Professional development Vacancies

Key performance indicators of the pharmacovigilance system of Ukraine for 2019

06.03.2020 Updated 21.05.2020 12427 views

Key indicators of the pharmacovigilance system of Ukraine for 2019 year

 

  1. ACTIVITY OF ADMINISTRATIVE-TERRITORIAL UNITS OF UKRAINE IN THE CONDUCT OF PHARMACOVIGILANCE

Table 1

NUMBER OF RECEIVED REPORTS OF AR/NPPI OF MEDICINAL PRODUCTS BY REGION

 

No. Region Number of reports received Including valid Including invalid
1 Vinnytsia Oblast 1606 1551 55
2 Volyn Oblast 378 360 18
3 Dnipropetrovsk Oblast 4605 4492 113
4 Donetsk Oblast 1339 1300 39
5 Zhytomyr Oblast 376 369 7
6 Zakarpattia Oblast 320 314 6
7 Zaporizhzhia Oblast 2035 1968 67
8 Ivano-Frankivsk Oblast 479 461 18
9 Kyiv Oblast 487 453 34
10 Kirovohrad Oblast 381 361 20
11 Luhansk Oblast 1032 1008 24
12 Lviv Oblast 805 778 27
13 Kyiv 2173 2067 106
14 Mykolaiv Oblast 1239 1203 36
15 Odesa Oblast 971 919 52
16 Poltava Oblast 963 931 32
17 Rivne Oblast 477 463 14
18 Sumy Oblast 351 345 6
19 Ternopil Oblast 688 670 18
20 Kharkiv Oblast 2343 2249 94
21 Kherson Oblast 1439 1329 110
22 Khmelnytskyi Oblast 1285 1223 62
23 Cherkasy Oblast 423 404 19
24 Chernivtsi Oblast 643 583 60
25 Chernihiv Oblast 506 499 7
26 Not determined 80 70 10
Total 27424 26370 1054

 

Note: * – temporarily occupied territory of Ukraine

** – territories of Luhansk and Donetsk oblasts controlled by Ukraine

*** – reports received from patients, registration certificate holders without indication of the region

 

  1. DISTRIBUTION OF MEDICINAL PRODUCTS BY PHARMACOLOGICAL GROUPS AND INTERNATIONAL NONPROPRIETARY NAME (INN), IN CONNECTION WITH WHICH REPORTS ON AR/NPPI WERE RECEIVED

Table 2a

PHARMACOTHERAPEUTIC GROUPS OF MEDICINAL PRODUCTS FOR WHICH REPORTS OF AR/NPPI WERE RECEIVED (first level ATC)

 

ATC Pharmacotherapeutic group of the medicinal product By number of AR/NPPI By number of AR/NPPI (%)
    Previous-year period Current period Previous-year period Current period
A Agents affecting the digestive system and metabolism 1291 1281 5,3% 4,6%
B Agents affecting the blood system and hematopoiesis 1027 966 4,2% 3,5%
C Agents affecting the cardiovascular system 2799 2855 11,5% 10,3%
D Dermatological agents 150 157 0,6% 0,6%
G Agents affecting the genitourinary system and sex hormones 173 183 0,7% 0,7%
H Systemic hormonal preparations, excluding sex hormones and insulins 77 63 0,3% 0,2%
J Antimicrobial agents for systemic use 14457 17439 59,2% 63,1%
L Antineoplastic and immunomodulating agents 171 175 0,7% 0,6%
M Agents affecting the musculoskeletal system 1010 1053 4,1% 3,8%
N Agents acting on the nervous system 2088 1995 8,5% 7,2%
P Antiparasitic agents, insecticides and repellents 31 29 0,1% 0,1%
R Agents acting on the respiratory system 836 866 3,4% 3,1%
S Agents acting on the sensory organs 133 134 0,5% 0,5%
V Miscellaneous agents 67 47 0,3% 0,2%
Not determined 120 375 0,5% 1,4%
Total 24430 27618 100,0% 100,0%

 

Table 2b

PHARMACOTHERAPEUTIC GROUPS OF MEDICINAL PRODUCTS FOR WHICH AR/AEFI REPORTS WERE RECEIVED (second level ATC)Pharmacotherapeutic groups of medicinal products for which AR/AEFI reports were received (second level ATC)

 

ATC Pharmacotherapeutic group of the medicinal product Quantity %
A01 Agents for use in dentistry 20 0,1%
A02 Agents for the treatment of acid-related disorders 162 0,6%
A03 Agents used in functional gastrointestinal disorders 225 0,8%
A04 Antiemetics and anti-nausea preparations 8 0,0%
A05 Agents used to treat diseases of the liver and biliary tract 110 0,4%
A06 Laxatives 4 0,0%
A07 Antidiarrheal agents, products used to treat infectious and inflammatory bowel diseases 46 0,2%
A09 Replacement therapy agents used in digestive disorders, including enzymes 26 0,1%
A10 Antidiabetic agents 244 0,9%
A11 Vitamins 278 1,0%
A12 Mineral supplements 27 0,1%
A13 Tonic preparations 1 0,0%
A14 Anabolic agents for systemic use 2 0,0%
A15 Appetite stimulants 1 0,0%
A16 Other agents affecting the digestive system and metabolic processes 127 0,5%
B01 Antithrombotic agents 202 0,7%
B02 Antihemorrhagic agents 67 0,2%
B03 Antianemic preparations 127 0,5%
B05 Blood substitutes and perfusion solutions 565 2,0%
B06 Other hematological agents 5 0,0%
C01 Cardiac preparations 508 1,8%
C02 Antihypertensive agents 15 0,1%
C03 Diuretic preparations 120 0,4%
C04 Peripheral vasodilators 165 0,6%
C05 Angioprotectors 204 0,7%
C07 Beta-adrenoceptor blockers 204 0,7%
C08 Calcium antagonists 652 2,4%
C09 Agents acting on the renin-angiotensin system 858 3,1%
C10 Lipid-lowering agents 129 0,5%
D01 Antifungal agents for use in dermatology 17 0,1%
D02 Preparations with emollient and protective action 2 0,0%
D03 Agents for the treatment of wounds and ulcerative lesions 19 0,1%
D04 Antipruritic agents (including antihistamines, local anesthetics, and other agents) 6 0,0%
D06 Antibiotics and chemotherapeutic agents for use in dermatology 23 0,1%
D07 Corticosteroids for use in dermatology 13 0,0%
D08 Antiseptics and disinfectants 73 0,3%
D10 Acne treatments 4 0,0%
G01 Antimicrobial and antiseptic agents used in gynecology 79 0,3%
G02 Other gynecological agents 19 0,1%
G03  Sex gland hormones and preparations used in disorders of the reproductive system 36 0,1%
G04 Agents used in urology 49 0,2%
H01 Pituitary and hypothalamic hormones and their analogues 9 0,0%
H02 Corticosteroids for systemic use 36 0,1%
H03 Thyrotropic agents 17 0,1%
H05 Agents regulating calcium metabolism 1 0,0%
J01 Antibacterial agents for systemic use 5751 20,8%
J02 Antifungal agents for systemic use 20 0,1%
J04 Agents acting on mycobacteria 8337 30,2%
J05 Antiviral agents for systemic use 1170 4,2%
J06 Immune sera and immunoglobulins 11 0,0%
J07 Vaccines 2150 7,8%
L01 Ixabepilone 109 0,4%
L02 Agents used for hormone therapy 6 0,0%
L03 Immunostimulants 48 0,2%
L04 Immunosuppressants 12 0,0%
M01 Anti-inflammatory and antirheumatic agents 855 3,1%
M02 Topical agents for joint and muscle pain 66 0,2%
M03 Muscle relaxants 86 0,3%
M04 Agents used for the treatment of gout 14 0,1%
M05 Agents used for treatment of bone diseases 8 0,0%
M09 Other agents used in musculoskeletal pathology 24 0,1%
N01 Anesthetics 377 1,4%
N02 Analgesics 339 1,2%
N03 Antiepileptic agents 152 0,6%
N04 Antiparkinsonian agents 7 0,0%
N05 Psycholeptic agents 581 2,1%
N06 Psychoanaleptics 324 1,2%
N07 Other agents acting on the nervous system 215 0,8%
P01 Antiprotozoal agents 12 0,0%
P02 Anthelmintic agents 14 0,1%
P03 Agents acting on ectoparasites, including preparations for the treatment of scabies and repellents 3 0,0%
R01 Agents used for diseases of the nasal cavity 58 0,2%
R02 Preparations used for throat diseases 109 0,4%
R03 Agents for the treatment of obstructive airway diseases 175 0,6%
R05 Agents used for cough and cold-related diseases 436 1,6%
R06 Antihistamines for systemic use 83 0,3%
R07 Other agents acting on the respiratory system 5 0,0%
S01 Agents used in ophthalmology 115 0,4%
S02 Preparations used in otology 11 0,0%
S03 Preparations used in ophthalmology and otology 8 0,0%
V03 All other medicinal products 11 0,0%
V04 Diagnostic agents 0 0,0%
V06 General-purpose nutrients 5 0,0%
V07 All other medical devices 0 0,0%
V08 Contrast agents 31 0,1%
Not determined 375 1,4%

 

Table 2v

MEDICINAL PRODUCTS (BY INN) WHOSE USE PROMPTED REPORTS OF AR/NPPI

 

No. INN Total cases <>* ve* nn* np* sn* sp* NPPI*
1 Abacavir 1 0 0 0 1 0 0 0
2 Abacavir; Lamivudine and abacavir 1 0 0 0 0 0 1 0
3 Aceclofenac 12 0 0 0 11 0 1 0
4 Acetazolamide 4 0 0 0 4 0 0 0
5 Acetylcysteine 27 0 0 0 27 0 0 0
6 Acetylsalicylic acid 46 0 0 0 38 0 8 0
7 Acetylsalicylic acid, combinations excl. psycholeptics 14 0 0 0 11 0 3 0
8 Aciclovir 15 0 0 0 15 0 0 0
9 Ademetionine 11 0 0 0 11 0 0 0
10 Adenosine 6 0 0 0 6 0 0 0
11 Agni casti fructus 4 0 0 0 4 0 0 0
12 Albendazole 12 0 0 0 12 0 0 0
13 Albumin 3 0 0 0 3 0 0 0
14 Alendronic acid 5 0 0 0 5 0 0 0
15 Allopurinol 10 0 0 0 10 0 0 0
16 Aloe** 5 0 0 0 5 0 0 0
17 Alprostadil 3 0 0 0 3 0 0 0
18 Alteplase 1 0 0 0 1 0 0 0
19 Althaea officinalis** 7 0 0 0 6 0 1 0
20 Althea root 2 0 0 0 2 0 0 0
21 Aluminium hydroxide, combinations* 2 0 0 0 2 0 0 0
22 Aluminium phosphate 1 0 0 0 1 0 0 0
23 Alverine, combinations 1 0 0 0 1 0 0 0
24 Amantadine 1 0 0 0 1 0 0 0
25 Ambazone 2 0 0 0 2 0 0 0
26 Ambroxol 113 0 0 0 109 0 4 0
27 Amikacin 36 0 0 0 33 0 3 0
28 Amino acids 2 0 0 0 2 0 0 0
29 Aminobutyric acid 4 0 0 0 4 0 0 0
30 Aminocaproic acid 3 0 0 0 3 0 0 0
31 Amiodarone 66 0 0 0 59 0 7 0
32 Amisulpride 14 0 0 0 14 0 0 0
33 Amitriptyline 26 0 0 0 25 0 1 0
34 Amlodipine 547 0 0 0 543 0 4 0
35 Amlodipine and diuretics 6 0 0 0 6 0 0 0
36 Amoxicillin 141 0 0 0 132 0 9 0
37 Amoxicillin and enzyme inhibitor 372 0 1 0 343 0 28 0
38 Amphotericin B 2 0 0 0 1 0 1 0
39 Ampicillin 11 0 0 0 10 0 1 0
40 Ampicillin and enzyme inhibitor 14 0 0 0 13 0 1 0
41 Anastrozole 1 0 0 0 1 0 0 0
42 Antral* 16 0 0 0 16 0 0 0
43 Aprotinin 24 0 0 0 15 0 9 0
44 Arginine glutamate 32 0 0 0 30 0 2 0
45 Arginine hydrochloride 160 0 0 0 154 0 6 0
46 Aripiprazole 34 0 0 0 33 0 1 0
47 Articaine, combinations 121 0 0 0 92 0 29 0
48 Ascorbic acid (vit C) 20 0 0 0 19 0 1 0
49 Asparaginase 2 0 0 0 2 0 0 0
50 Atazanavir 148 0 0 0 109 0 39 0
51 Atenolol 6 0 0 0 6 0 0 0
52 Atenolol and other antihypertensives 14 0 0 0 14 0 0 0
53 Atenolol and other diuretics 1 0 0 0 1 0 0 0
54 Atomoxetine 1 0 0 0 1 0 0 0
55 Atorvastatin 24 0 0 0 24 0 0 0
56 Atorvastatin and amlodipine 1 0 0 0 1 0 0 0
57 Atracurium 12 0 0 0 2 0 10 0
58 Atropine 6 0 0 0 4 0 2 0
59 Azathioprine 2 0 0 0 2 0 0 0
60 Azilsartan medoxomil 3 0 0 0 3 0 0 0
61 Azithromycin 244 0 0 0 239 0 5 0
62 Barbiturates in combination with other drugs 17 0 0 0 17 0 0 0
63 Beclometasone 3 0 0 0 3 0 0 0
64 Bedaquiline 133 0 0 0 123 0 10 0
65 Bendamustine 1 0 0 0 1 0 0 0
66 Bendazol* 2 0 0 0 2 0 0 0
67 Benzocaine 3 0 0 0 3 0 0 0
68 Benzydamine 7 0 0 0 6 0 1 0
69 Benzyl benzoate 3 0 0 0 3 0 0 0
70 Benzylpenicillin 4 0 0 0 4 0 0 0
71 Betahistine 16 0 0 0 16 0 0 0
72 Betamethasone 11 0 0 0 11 0 0 0
73 Betamethasone and antibiotics 3 0 0 0 2 0 1 0
74 Betaxolol 4 0 0 0 4 0 0 0
75 Bicalutamide 3 0 0 0 3 0 0 0
76 Biclotymol* 2 0 0 0 2 0 0 0
77 Bilastine 2 0 0 0 2 0 0 0
78 Biotin 2 0 0 0 2 0 0 0
79 Bisacodyl 1 0 0 0 1 0 0 0
80 Bismuth subcitrate 11 0 0 0 11 0 0 0
81 Bisoprolol 92 0 0 0 89 0 3 0
82 Bisoprolol and amlodipine 2 0 0 0 2 0 0 0
83 Boric acid 1 0 0 0 1 0 0 0
84 Bosutinib 2 0 0 0 2 0 0 0
85 Botulinum antitoxin 1 0 0 0 1 0 0 0
86 Brimonidine 1 0 0 0 1 0 0 0
87 Brinzolamide 5 0 0 0 5 0 0 0
88 Brinzolamide, combinations 3 0 0 0 3 0 0 0
89 Bromhexine 6 0 0 0 6 0 0 0
90 Bromocriptine 1 0 0 0 1 0 0 0
91 Budesonide 10 0 0 0 10 0 0 0
92 Bupivacaine 9 0 2 0 4 0 3 0
93 Butamirate 1 0 0 0 1 0 0 0
94 Butorphanol 4 0 0 0 4 0 0 0
95 Butylscopolamine 2 0 0 0 2 0 0 0
96 Cabergoline 3 0 0 0 3 0 0 0
97 Caffeine and sodium benzoate 1 0 0 0 1 0 0 0
98 Calcium chloride 1 0 0 0 1 0 0 0
99 Calcium gluconate 5 0 0 0 4 0 1 0
100 Calendula officinalis** 2 0 0 0 2 0 0 0
101 Candesartan 8 0 0 0 8 0 0 0
102 Candesartan and diuretics 1 0 0 0 1 0 0 0
103 Capreomycin 508 0 0 0 429 0 79 0
104 Captopril 25 0 0 0 25 0 0 0
105 Captopril and diuretics 33 0 0 0 33 0 0 0
106 Carbamazepine 47 0 0 0 45 0 2 0
107 Carbamide 2 0 0 0 2 0 0 0
108 Carbimazole 2 0 0 0 2 0 0 0
109 Carbocisteine 15 0 0 0 13 0 2 0
110 Carboplatin 8 0 0 0 7 0 1 0
111 Carvedilol 46 0 0 0 42 0 4 0
112 Carvedilol and ivabradine 1 0 0 0 1 0 0 0
113 Cefalexin 5 0 0 0 5 0 0 0
114 Cefazolin 10 0 0 0 8 0 2 0
115 Cefepime 46 0 0 0 44 0 2 0
116 Cefixime 62 0 0 0 58 0 4 0
117 Cefoperazone 32 0 0 0 28 0 4 0
118 Cefoperazone and beta-lactamase inhibitor 30 0 0 0 27 0 3 0
119 Cefotaxime 75 0 0 0 68 0 7 0
120 Cefpodoxime 60 0 0 0 57 0 3 0
121 Ceftazidime 48 0 0 0 45 0 3 0
122 Ceftriaxone 881 0 0 0 748 0 133 0
123 Ceftriaxone, combinations 29 0 0 0 28 0 1 0
124 Cefuroxime 53 0 0 0 50 0 3 0
125 Cetirizine 5 0 0 0 5 0 0 0
126 Chloramphenicol 13 0 0 0 10 0 3 0
127 Chlorhexidine 11 0 0 0 11 0 0 0
128 Chlorhexidine, combinations 3 0 0 0 3 0 0 0
129 Chlormadinone and ethinylestradiol 1 0 0 0 1 0 0 0
130 Chlorophyllipt* 22 0 0 0 21 0 1 0
131 Chloropyramine 13 0 0 0 11 0 2 0
132 Chlorpromazine 31 0 0 0 30 0 1 0
133 Chlorprothixene 6 0 0 0 6 0 0 0
134 Choline alfoscerate 33 0 0 0 30 0 3 0
135 Chondroitin sulfate 11 0 0 0 11 0 0 0
136 Chymotrypsin 1 0 0 0 1 0 0 0
137 Ciclosporin 1 0 0 0 1 0 0 0
138 Cilostazol 7 0 0 0 6 0 1 0
139 Cimicifugae rhizoma 1 0 0 0 1 0 0 0
140 Cineole 1 0 0 0 1 0 0 0
141 Cinnarizine 5 0 0 0 5 0 0 0
142 Cinnarizine, combinations 6 0 0 0 5 0 1 0
143 Ciprofloxacin 105 0 0 0 98 0 7 0
144 Ciprofloxacin and ornidazole 6 0 0 0 6 0 0 0
145 Ciprofloxacin and tinidazole 9 0 0 0 9 0 0 0
146 Cisplatin 9 0 0 0 9 0 0 0
147 Citicoline 66 0 0 0 61 0 5 0
148 Clarithromycin 55 0 0 0 54 0 1 0
149 Clemastine 2 0 0 0 2 0 0 0
150 Clindamycin 6 0 0 0 6 0 0 0
151 Clindamycin, combinations 1 0 0 0 1 0 0 0
152 Clofazimine 257 0 0 0 240 0 17 0
153 Clomipramine 3 0 0 0 2 0 1 0
154 Clonidine 5 0 0 0 5 0 0 0
155 Clopidogrel 94 0 0 0 91 0 3 0
156 Clotrimazole 12 0 0 0 12 0 0 0
157 Clozapine 32 0 0 0 30 0 2 0
158 Cocarboxylase* 5 0 0 0 4 0 1 0
159 Colecalciferol 9 0 0 0 9 0 0 0
160 Comb drug 763 0 0 0 727 0 36 0
161 Combinations of imidazole derivatives 4 0 0 0 4 0 0 0
162 Combinations of vitamins 5 0 0 0 5 0 0 0
163 Cough suppressants and expectorants 5 0 0 0 5 0 0 0
164 Cough suppressants and mucolytics 11 0 0 0 11 0 0 0
165 Cromoglicic acid 1 0 0 0 1 0 0 0
166 Cyanocobalamin 30 0 0 0 30 0 0 0
167 Cyclobenzaprine 1 0 0 0 1 0 0 0
168 Cycloferon* 1 0 0 0 1 0 0 0
169 Cyclopentolate 3 0 0 0 3 0 0 0
170 Cyclophosphamide 2 0 0 0 2 0 0 0
171 Cycloserine 603 0 0 0 529 0 74 0
172 Cynara scolymus** 6 0 0 0 5 0 1 0
173 Cytarabine 2 0 0 0 2 0 0 0
174 Cytisine 1 0 0 0 1 0 0 0
175 Cytochrom C* 9 0 0 0 8 0 1 0
176 Dabigatran etexilate 4 0 0 0 3 0 1 0
177 Dacarbazine 1 0 0 0 1 0 0 0
178 Dalargin* 6 0 0 0 4 0 2 0
179 Darunavir 1 0 0 0 1 0 0 0
180 Decamethoxine 20 0 0 0 19 0 1 0
181 Delamanid 15 0 0 0 15 0 0 0
182 Dequalinium 11 0 0 0 11 0 0 0
183 Desloratadine 12 0 0 0 12 0 0 0
184 Desmopressin 1 0 0 0 1 0 0 0
185 Desogestrel and ethinylestradiol 4 0 0 0 4 0 0 0
186 Dexamethasone 17 0 0 0 16 0 1 0
187 Dexamethasone and antiinfectives 9 0 0 0 9 0 0 0
188 Dexibuprofen 11 0 0 0 11 0 0 0
189 Dexketoprofen 60 0 0 0 58 0 2 0
190 Dexpanthenol 2 0 0 0 2 0 0 0
191 Dextran 17 0 0 0 14 0 3 0
192 Diacerein 1 0 0 0 1 0 0 0
193 Diatrizoic acid 13 0 0 0 12 0 1 0
194 Diazepam 19 0 0 0 7 0 12 0
195 Diclofenac 241 0 0 0 228 0 13 0
196 Diclofenac, combinations 32 0 0 0 30 0 2 0
197 Dienogest 1 0 0 0 1 0 0 0
198 Dienogest and ethinylestradiol 2 0 0 0 2 0 0 0
199 Digoxin 6 0 0 0 6 0 0 0
200 Dimethyl sulfoxide 14 0 0 0 14 0 0 0
201 Dimetindene 5 0 0 0 5 0 0 0
202 Diosmectite 3 0 0 0 3 0 0 0
203 Diosmin 5 0 0 0 5 0 0 0
204 Diosmin, combinations 23 0 0 0 22 0 1 0
205 Dioxydine* 2 0 0 0 2 0 0 0
206 Diphenhydramine 7 0 0 0 6 0 1 0
207 Diphtheria-Hemophilus influenzae B-pertussis-poliomyelitis-tetanus 6 0 0 0 5 0 0 1
208 Diphtheria-hemophilus influenzae B-pertussis-poliomyelitis-tetanus-hepatitis B 50 1 0 0 41 0 5 4
209 Diphtheria-Hemophilus influenzae B-pertussis-tetanus-hepatitis B 40 1 0 0 39 0 1 0
210 Diphtheria-pertussis-poliomyelitis-tetanus 9 0 0 0 8 0 1 0
211 Dipyridamole 5 0 0 0 5 0 0 0
212 Disulfiram 1 0 0 0 0 0 1 0
213 Docetaxel 6 0 0 0 6 0 0 0
214 Dolutegravir 67 0 0 0 60 0 7 0
215 Domperidone 9 0 0 0 9 0 0 0
216 Dopamine 1 0 0 0 1 0 0 0
217 Dorzolamide 3 0 0 0 3 0 0 0
218 Doxazosin 1 0 0 0 1 0 0 0
219 Doxofylline 6 0 0 0 6 0 0 0
220 Doxorubicin 11 0 0 0 10 0 1 0
221 Doxycycline 31 0 0 0 30 0 1 0
222 Doxylamine 2 0 0 0 2 0 0 0
223 Doxylamine, combinations 1 0 0 0 1 0 0 0
224 Drospirenone and estrogen 1 0 0 0 1 0 0 0
225 Drospirenone and ethinylestradiol 9 0 0 0 9 0 0 0
226 Drotaverine 57 0 0 0 55 0 2 0
227 Duloxetine 6 0 0 0 6 0 0 0
228 Dydrogesterone 1 0 0 0 1 0 0 0
229 Echinacea purpurea** 1 0 0 0 1 0 0 0
230 Econazole 2 0 0 0 2 0 0 0
231 Edaravone* 3 0 0 0 3 0 0 0
232 Efavirenz 40 0 0 0 38 0 2 0
233 Electrolytes 29 0 0 1 27 0 1 0
234 Electrolytes in combination with other drugs 163 0 0 0 153 0 10 0
235 Electrolytes with carbohydrates 19 0 0 0 16 0 3 0
236 Emicizumab 1 0 0 0 1 0 0 0
237 Emoxypin* 3 0 0 0 3 0 0 0
238 Empagliflozin 1 0 0 0 1 0 0 0
239 Emtricitabine, tenofovir disoproxil and efavirenz 331 0 0 0 294 0 37 0
240 Enalapril 315 0 0 0 314 0 1 0
241 Enalapril and diuretics 30 0 0 0 30 0 0 0
242 Enalapril and lercanidipine 3 0 0 0 3 0 0 0
243 Enalapril and nitrendipine 1 0 0 0 1 0 0 0
244 Enisamium iodide 15 0 0 0 15 0 0 0
245 Enoxaparin 7 0 0 0 6 0 1 0
246 Epirubicin 1 0 0 0 1 0 0 0
247 Eplerenone 6 0 0 0 6 0 0 0
248 Erdosteine 18 0 0 0 18 0 0 0
249 Erythromycin 3 0 0 0 3 0 0 0
250 Escitalopram 6 0 0 0 6 0 0 0
251 Esmolol 1 0 0 0 1 0 0 0
252 Esomeprazole 6 0 0 0 6 0 0 0
253 Etamsylate 8 0 0 0 8 0 0 0
254 Ethacizin* 3 0 0 0 3 0 0 0
255 Ethambutol 225 0 0 0 195 0 30 0
256 Ethionamide 807 0 0 0 731 0 76 0
257 Etodolac 3 0 0 0 2 0 1 0
258 Etoposide 4 0 0 0 2 0 2 0
259 Etoricoxib 2 0 0 0 2 0 0 0
260 Famotidine 7 0 0 0 7 0 0 0
261 Febuxostat 3 0 0 0 3 0 0 0
262 Felodipine 1 0 0 0 1 0 0 0
263 Fenoterol and ipratropium bromide 10 0 0 0 10 0 0 0
264 Fenspiride 35 0 0 0 34 0 1 0
265 Fentanyl 8 0 0 0 0 0 8 0
266 Fenticonazole 2 0 0 0 2 0 0 0
267 Ferric oxide dextran complex* 6 0 0 0 5 0 1 0
268 Ferric oxide polymaltose complexes 10 0 0 0 10 0 0 0
269 Ferrous fumarate 3 0 0 0 3 0 0 0
270 Ferrous sulfate 5 0 0 0 5 0 0 0
271 Ferrous sulfate with folic acid 6 0 0 0 6 0 0 0
272 Fexofenadine 1 0 0 0 1 0 0 0
273 Filgrastim 1 0 0 0 0 0 1 0
274 Flecainide 1 0 0 0 1 0 0 0
275 Fluconazole 15 0 0 0 15 0 0 0
276 Fluocinolone acetonide 1 0 0 0 1 0 0 0
277 Fluocinonide and antibiotics 3 0 0 0 3 0 0 0
278 Fluorescein 1 0 0 0 0 0 1 0
279 Fluorouracil 4 0 0 0 3 0 1 0
280 Fluoxetine 7 0 0 0 6 0 1 0
281 Flupenthixol 4 0 0 0 4 0 0 0
282 Fluphenazine 8 0 0 0 8 0 0 0
283 Flurbiprofen 1 0 0 0 1 0 0 0
284 Fluticasone 1 0 0 0 1 0 0 0
285 Folic acid 1 0 0 0 1 0 0 0
286 Formoterol 3 0 0 0 3 0 0 0
287 Formoterol and budesonide 2 0 0 0 2 0 0 0
288 Fosfomycin 9 0 0 0 9 0 0 0
289 Furazidin 22 0 0 0 19 0 3 0
290 Furosemide 12 0 0 0 12 0 0 0
291 Furosemide and potassium-sparing agents 1 0 0 0 1 0 0 0
292 Fusidic acid 1 0 0 0 1 0 0 0
293 Gabapentin 18 0 0 0 18 0 0 0
294 Gadoteric acid 3 0 0 0 3 0 0 0
295 Ganciclovir 2 0 0 0 2 0 0 0
296 Gatifloxacin 10 0 0 0 9 0 1 0
297 Gelatin agents 7 0 0 0 7 0 0 0
298 Gemcitabine 4 0 0 0 3 0 1 0
299 Gentamicin 12 0 0 0 11 0 1 0
300 Gestodene and ethinylestradiol 1 0 0 0 1 0 0 0
301 Ginkgo folium 1 0 0 0 1 0 0 0
302 Glatiramer acetate 2 0 0 0 2 0 0 0
303 Glaucine* 3 0 0 0 3 0 0 0
304 Glibenclamide 3 0 0 0 3 0 0 0
305 Gliclazide 16 0 0 0 16 0 0 0
306 Glimepiride 6 0 0 0 6 0 0 0
307 Glucosamine 5 0 0 0 5 0 0 0
308 Glucose 30 0 0 0 23 0 7 0
309 Glyceryl trinitrate 7 0 0 0 7 0 0 0
310 Glycine 11 0 0 0 11 0 0 0
311 Glycyrrhiza** 3 0 0 0 3 0 0 0
312 Goserelin 1 0 0 0 1 0 0 0
313 G-strophanthin 1 0 0 0 1 0 0 0
314 Haloperidol 147 0 0 0 146 0 1 0
315 Hederae helicis folium 25 0 0 0 23 0 2 0
316 Helichrysum arenarium** 1 0 0 0 1 0 0 0
317 Hemophilus influenzae B, purified antigen conjugated 59 2 0 0 51 0 4 4
318 Heparin 6 0 0 0 6 0 0 0
319 Heparin, combinations 4 0 0 0 4 0 0 0
320 Hepatitis A, inactivated, whole virus 1 0 0 0 1 0 0 0
321 Hepatitis B, purified antigen 37 7 0 0 24 0 5 8
322 Hexetidine 2 0 0 0 2 0 0 0
323 Hexoprenaline 4 0 0 0 4 0 0 0
324 Hippocastani semen 3 0 0 0 2 0 1 0
325 Hippophae rhamnoides** 1 0 0 0 1 0 0 0
326 Hopantenic acid* 2 0 0 0 2 0 0 0
327 Hyaluronidase 5 0 0 0 5 0 0 0
328 Hydazepam* 6 0 0 0 6 0 0 0
329 Hydrochlorothiazide 14 0 0 0 14 0 0 0
330 Hydrocortisone 1 0 0 0 1 0 0 0
331 Hydrocortisone and antibiotics 1 0 0 0 1 0 0 0
332 Hydroxyethylstarch 1 0 0 0 1 0 0 0
333 Hydroxyzine 2 0 0 0 2 0 0 0
334 Ibandronic acid 1 0 0 0 1 0 0 0
335 Ibuprofen 205 0 0 0 202 0 3 0
336 Ibuprofen, combinations 3 0 0 0 3 0 0 0
337 Iloprost 3 0 0 0 3 0 0 0
338 Imatinib 1 0 0 0 0 0 1 0
339 Imipenem and cilastatin 2 0 0 0 1 0 1 0
340 Imipenem and enzyme inhibitor 64 0 0 0 58 0 6 0
341 Immunoglobulins, normal human, for intravascular adm. 1 0 0 0 1 0 0 0
342 Indapamide 18 0 0 0 18 0 0 0
343 Indometacin 6 0 0 0 5 0 1 0
344 Infliximab 1 0 0 0 1 0 0 0
345 Influenza, inactivated, split virus or surface antigen 5 0 0 0 5 0 0 0
346 Inosine 19 0 0 0 18 0 1 0
347 Inosine pranobex 29 0 0 0 28 0 1 0
348 Insulin (human) 34 0 0 0 34 0 0 0
349 Insulin aspart 4 0 0 0 4 0 0 0
350 Insulin degludec 1 0 0 0 1 0 0 0
351 Insulin degludec and insulin aspart 2 0 0 0 2 0 0 0
352 Insulin detemir 2 0 0 0 2 0 0 0
353 Insulin glargine 2 0 0 0 2 0 0 0
354 Interferon alfa-2b 10 0 0 0 8 0 2 0
355 Interferon beta-1a 1 0 0 0 1 0 0 0
356 Iodine 12 0 0 0 12 0 0 0
357 Iodixanol 3 0 0 0 3 0 0 0
358 Iohexol 4 0 0 0 3 0 1 0
359 Iopromide 4 0 0 0 2 0 2 0
360 Ipidacrine 12 0 0 0 11 0 1 0
361 Ipratropium bromide 1 0 0 0 1 0 0 0
362 Irbesartan and diuretics 1 0 0 0 1 0 0 0
363 Irinotecan 2 0 0 0 1 0 1 0
364 Iron, parenteral preparations 6 0 0 0 6 0 0 0
365 Iron, vitamin B12 and folic acid 1 0 0 0 1 0 0 0
366 Isoniazid 860 0 0 0 779 0 81 0
367 Isosorbide dinitrate 88 0 0 0 84 0 4 0
368 Isosorbide mononitrate 7 0 0 0 7 0 0 0
369 Isoxsuprine 2 0 0 0 2 0 0 0
370 Itraconazole 1 0 0 0 1 0 0 0
371 Josamycin 5 0 0 0 4 0 1 0
372 Kanamycin 658 0 0 0 544 0 114 0
373 Ketamine 3 0 0 0 3 0 0 0
374 Ketoconazole 6 0 0 0 6 0 0 0
375 Ketoprofen 14 0 0 0 12 0 2 0
376 Ketorolac 39 0 0 0 37 0 2 0
377 Ketotifen 2 0 0 0 2 0 0 0
378 Lactic acid producing organisms, combinations 2 0 0 0 2 0 0 0
379 Lactulose 1 0 0 0 1 0 0 0
380 Lamivudine 3 0 0 0 3 0 0 0
381 Lamivudine and abacavir 54 0 0 0 50 0 4 0
382 Lamivudine, abacavir and dolutegravir 1 0 0 0 1 0 0 0
383 Lamivudine, tenofovir disoproxil and efavirenz 1 0 0 0 1 0 0 0
384 Lamotrigine 9 0 0 0 7 0 2 0
385 Lansoprazole 1 0 0 0 1 0 0 0
386 Lansoprazole, clarithromycin and tinidazole 5 0 0 0 5 0 0 0
387 Latanoprost 7 0 0 0 7 0 0 0
388 Lavandulae aetheroleum 1 0 0 0 1 0 0 0
389 Leflunomide 2 0 0 0 2 0 0 0
390 Lercanidipine 19 0 0 0 19 0 0 0
391 Lespedeza bicolor** 1 0 0 0 1 0 0 0
392 Levetiracetam 1 0 0 0 1 0 0 0
393 Levocarnitine 4 0 0 1 2 0 1 0
394 Levocetirizine 23 0 0 0 23 0 0 0
395 Levodopa and decarboxylase inhibitor 4 0 0 0 4 0 0 0
396 Levodropropizine 27 0 0 0 27 0 0 0
397 Levofloxacin 1120 0 0 0 1024 0 96 0
398 Levofloxacin and ornidazole 7 0 0 0 6 0 1 0
399 Levomepromazine 5 0 0 0 5 0 0 0
400 Levonorgestrel 1 0 0 0 0 0 1 0
401 Levothyroxine sodium 6 0 0 0 6 0 0 0
402 Lidocaine 202 0 0 0 179 0 23 0
403 Lincomycin 28 0 0 0 27 0 1 0
404 Linezolid 614 0 0 0 554 0 60 0
405 Lisinopril 65 0 0 0 63 0 2 0
406 Lisinopril and amlodipine 8 0 0 0 8 0 0 0
407 Lisinopril and diuretics 39 0 0 0 38 0 1 0
408 Lomefloxacin 2 0 0 0 2 0 0 0
409 Loperamide 5 0 0 0 5 0 0 0
410 Loperamide, combinations 1 0 0 0 1 0 0 0
411 Lopinavir and ritonavir 84 0 0 0 82 0 2 0
412 Loratadine 5 0 0 0 5 0 0 0
413 Lornoxicam 20 0 0 0 19 0 1 0
414 Losartan 94 0 0 0 93 0 1 0
415 Losartan and diuretics 4 0 0 0 4 0 0 0
416 Lysine 103 0 0 0 98 0 5 0
417 Macrogol 1 0 0 0 1 0 0 0
418 Magnesium (different salts in combination) 12 0 0 0 12 0 0 0
419 Magnesium oxide 1 0 0 0 1 0 0 0
420 Magnesium sulfate 57 0 0 0 56 0 1 0
421 Mannitol 6 0 0 0 5 0 1 0
422 Measles, combinations with mumps and rubella, live attenuated 54 4 0 0 43 0 6 5
423 Measles, combinations with mumps, rubella and varicella, live attenuated 1 0 0 0 0 0 1 0
424 Mebendazole 1 0 0 0 1 0 0 0
425 Mebeverine 6 0 0 0 6 0 0 0
426 Mebhydrolin 6 0 0 0 6 0 0 0
427 Mebicar 6 0 0 0 6 0 0 0
428 Mecobalamin 4 0 0 0 4 0 0 0
429 Mefenamic acid 34 0 0 0 33 0 1 0
430 Melatonin 3 0 0 0 3 0 0 0
431 Meldonium 87 0 0 0 80 0 7 0
432 Meloxicam 84 0 0 0 79 0 5 0
433 Memantine 5 0 0 0 5 0 0 0
434 Mepivacaine 2 0 0 0 1 0 1 0
435 Meropenem 120 0 0 0 110 0 10 0
436 Metamizole sodium 72 0 0 0 67 0 5 0
437 Metamizole sodium, combinations excl. psycholeptics 6 0 0 0 5 0 1 0
438 Metamizole sodium, combinations with psycholeptics 8 0 0 0 7 0 1 0
439 Metformin 151 0 0 0 151 0 0 0
440 Metformin and dapagliflozin 1 0 0 0 1 0 0 0
441 Metformin and empagliflozin 1 0 0 0 1 0 0 0
442 Metformin and sulfonamides 6 0 0 0 6 0 0 0
443 Methadone 3 0 0 0 3 0 0 0
444 Methotrexate 11 0 0 0 8 0 3 0
445 Methylii salicylas* 1 0 0 0 1 0 0 0
446 Methylprednisolone 3 0 0 0 3 0 0 0
447 Methyluracil* 2 0 0 0 2 0 0 0
448 Metoclopramide 24 0 0 0 23 0 1 0
449 Metoprolol 24 0 0 0 23 0 1 0
450 Metronidazole 72 0 0 0 70 0 2 0
451 Mexidol* 80 0 0 0 78 0 2 0
452 Mexiletine 1 0 0 0 1 0 0 0
453 Mianserin 3 0 0 0 3 0 0 0
454 Miconazole 1 0 0 0 1 0 0 0
455 Midecamycin 1 0 0 0 1 0 0 0
456 Mirtazapine 1 0 0 0 1 0 0 0
457 Mitoxantrone 1 0 0 0 0 0 1 0
458 Molsidomine 29 0 0 0 29 0 0 0
459 Mometasone 12 0 0 0 11 0 1 0
460 Mono 108 0 0 0 104 0 4 0
461 Montelukast 14 0 0 0 14 0 0 0
462 Montelukast, combinations 1 0 0 0 1 0 0 0
463 Morphine 6 0 0 0 6 0 0 0
464 Moxifloxacin 316 0 0 0 282 0 34 0
465 Moxonidine 2 0 0 0 2 0 0 0
466 Multienzymes (lipase, protease etc.) 22 0 0 0 22 0 0 0
467 Multivitamins and other minerals, incl. combinations 5 0 0 0 5 0 0 0
468 Multivitamins and trace elements 5 0 0 0 5 0 0 0
469 Mupirocin 2 0 0 0 2 0 0 0
470 Mycophenolic acid 3 0 0 0 3 0 0 0
471 Myramistin* 7 0 0 0 7 0 0 0
472 Nabumetone 3 0 0 0 3 0 0 0
473 Nalbuphine 16 0 0 0 14 0 2 0
474 Naphazoline 4 0 0 0 4 0 0 0
475 Naproxen 8 0 0 0 7 0 1 0
476 Natamycin 1 0 0 0 1 0 0 0
477 Nebivolol 8 0 0 0 8 0 0 0
478 Nebivolol and thiazides 1 0 0 0 1 0 0 0
479 Neostigmine 6 0 0 0 5 0 1 0
480 Nicergoline 2 0 0 0 1 0 1 0
481 Nicotinic acid 40 0 0 0 38 0 2 0
482 Nifedipine 51 0 0 0 50 0 1 0
483 Nifuratel 1 0 0 0 1 0 0 0
484 Nifuroxazide 18 0 0 0 16 0 2 0
485 Nikethamide 2 0 0 0 2 0 0 0
486 Nimesulide 59 0 0 0 56 0 3 0
487 Nimodipine 2 0 0 0 2 0 0 0
488 Nitrendipine 1 0 0 0 1 0 0 0
489 Nitrofural 2 0 0 0 2 0 0 0
490 Nitrofurantoin 10 0 0 0 10 0 0 0
491 Nitroxoline 6 0 0 0 6 0 0 0
492 Norethisterone 1 0 0 0 1 0 0 0
493 Norfloxacin 11 0 0 0 11 0 0 0
494 Nystatin 2 0 0 0 2 0 0 0
495 Nystatin, combinations 3 0 0 0 3 0 0 0
496 Octenidine, combinations 1 0 0 0 1 0 0 0
497 Octreotide 1 0 0 0 1 0 0 0
498 Ofloxacin 36 0 0 0 35 0 1 0
499 Ofloxacin and ornidazole 9 0 0 0 8 0 1 0
500 Olanzapine 3 0 0 0 3 0 0 0
501 Olmesartan medoxomil 1 0 0 0 1 0 0 0
502 Olmesartan medoxomil and amlodipine 1 0 0 0 1 0 0 0
503 Omeprazole 31 0 0 0 29 0 2 0
504 Omeprazole, amoxicillin and clarithromycin 4 0 0 0 3 0 1 0
505 Ondansetron 8 0 0 0 6 0 2 0
506 Opium derivatives and expectorants 2 0 0 0 1 0 1 0
507 Ordinary salt combinations 3 0 0 0 3 0 0 0
508 Ornidazole 20 0 0 0 18 0 2 0
509 Ornithine* 10 0 0 1 8 0 1 0
510 Oseltamivir 1 0 0 0 1 0 0 0
511 Otilonium bromide 1 0 0 0 1 0 0 0
512 Oxaliplatin 9 0 0 0 6 0 3 0
513 Oxybuprocaine 1 0 0 0 1 0 0 0
514 Oxybutynin 3 0 0 0 3 0 0 0
515 Oxymetazoline 15 0 0 0 15 0 0 0
516 Oxytocin 6 0 0 0 6 0 0 0
517 Paclitaxel 15 0 0 0 12 0 3 0
518 Pantoprazole 44 0 0 0 44 0 0 0
519 Papaverine 14 0 0 0 14 0 0 0
520 Paracetamol 111 0 0 0 106 0 5 0
521 Paracetamol, combinations excl. psycholeptics 72 0 0 0 66 0 6 0
522 Parecoxib 2 0 0 0 1 0 1 0
523 Pasiflora incarnata** 1 0 0 0 1 0 0 0
524 Pegaspargase 2 0 0 0 1 0 1 0
525 Pegfilgrastim 1 0 0 0 1 0 0 0
526 Peginterferon alfa-2a 4 0 0 0 4 0 0 0
527 Pelargonii radix** 8 0 0 0 8 0 0 0
528 Pentoxifylline 99 0 0 0 98 0 1 0
529 Perindopril 12 0 0 0 12 0 0 0
530 Perindopril and amlodipine 16 0 0 0 16 0 0 0
531 Perindopril and bisoprolol 5 0 0 0 5 0 0 0
532 Perindopril and diuretics 35 0 0 0 35 0 0 0
533 Perindopril, amlodipine and indapamide 52 0 0 0 51 0 1 0
534 Pertussis, purified antigen, combinations with toxoids 1575 38 0 0 1485 0 66 24
535 Phenazepam* 2 0 0 0 2 0 0 0
536 Phenibut 19 0 0 0 19 0 0 0
537 Phenol 18 0 0 0 18 0 0 0
538 Phenylephrine 3 0 0 0 3 0 0 0
539 Phenylephrine, combinations 4 0 0 0 4 0 0 0
540 Phthalylsulfathiazole 1 0 0 0 1 0 0 0
541 Pinaverium bromide 1 0 0 0 1 0 0 0
542 Pioglitazone 2 0 0 0 2 0 0 0
543 Pipemidic acid 3 0 0 0 3 0 0 0
544 Piperacillin and enzyme inhibitor 2 0 0 0 1 0 1 0
545 Piracetam 26 0 0 0 26 0 0 0
546 Piroxicam 4 0 0 0 4 0 0 0
547 Pitofenone and analgesics 58 0 0 0 50 0 8 0
548 Plantago** 4 0 0 0 4 0 0 0
549 Platyphylline* 8 0 0 0 8 0 0 0
550 Pneumococcus purified polysaccharides antigen and Haemophilus influenzae, conjugated 7 0 0 0 6 0 1 0
551 Pneumococcus, purified polysaccharides antigen conjugated 2 0 0 0 1 0 0 1
552 Poliomyelitis oral, bivalent, live attenuated 36 1 0 0 32 0 0 4
553 Poliomyelitis, trivalent, inactivated, whole virus 91 8 0 0 77 0 7 7
554 Potassium and magnesium aspartate* 1 0 0 0 1 0 0 0
555 Potassium chloride 2 0 0 0 2 0 0 0
556 Potassium iodide 3 0 0 0 3 0 0 0
557 Povidone-iodine 20 0 0 0 19 0 1 0
558 Pramipexole 1 0 0 0 1 0 0 0
559 Pramiracetam 1 0 0 0 1 0 0 0
560 Prednisolone 7 0 0 0 7 0 0 0
561 Pregabalin 48 0 0 0 46 0 2 0
562 Prenoxdiazine 4 0 0 0 4 0 0 0
563 Prifinium bromide 11 0 0 0 11 0 0 0
564 Procainamide 4 0 0 0 4 0 0 0
565 Procaine 24 0 0 0 22 0 2 0
566 Prochlorperazine 5 0 0 0 5 0 0 0
567 Progesterone 12 0 0 0 12 0 0 0
568 Propafenone 6 0 0 0 4 0 2 0
569 Propofol 24 0 0 1 3 0 20 0
570 Propolis* 1 0 0 0 1 0 0 0
571 Propranolol 7 0 0 0 7 0 0 0
572 Propyphenazone, combinations with psycholeptics 1 0 0 0 1 0 0 0
573 Protionamide 430 0 0 0 392 0 38 0
574 Proxymetacaine 1 0 0 0 1 0 0 0
575 Pyrazinamide 2437 0 0 0 2150 0 287 0
576 Pyridostigmine bromide 2 0 0 0 2 0 0 0
577 Pyridoxine (vit B6) 18 0 0 0 17 0 1 0
578 Quercetin* 1 0 0 0 1 0 0 0
579 Quetiapine 23 0 0 0 20 0 3 0
580 Rabeprazole 16 0 0 0 16 0 0 0
581 Rabies immunoglobulin 6 0 0 0 5 0 1 0
582 Rabies, inactivated, whole virus 4 0 0 0 4 0 0 0
583 Ramipril 32 0 0 0 31 0 1 0
584 Ramipril and amlodipine 3 0 0 0 3 0 0 0
585 Ramipril and diuretics 5 0 0 0 5 0 0 0
586 Ranitidine 12 0 0 0 12 0 0 0
587 Rebamipide 3 0 0 0 3 0 0 0
588 Reserpine and diuretics, combinations with other drugs 2 0 0 0 2 0 0 0
589 Rifabutin 14 0 0 0 13 0 1 0
590 Rifampicin 611 0 0 0 557 0 54 0
591 Rifampicin and isoniazid 157 0 0 0 153 0 4 0
592 Rifampicin, ethambutol, isoniazid* 1 0 0 0 1 0 0 0
593 Rifampicin, pyrazinamide, ethambutol and isoniazid 687 0 0 0 648 0 39 0
594 Rimantadine 20 0 0 0 20 0 0 0
595 Risperidone 100 0 0 0 97 0 3 0
596 Ritonavir 12 0 0 0 7 0 5 0
597 Rituximab 6 0 0 0 5 0 1 0
598 Rivaroxaban 3 0 0 0 3 0 0 0
599 Rizatriptan 1 0 0 0 1 0 0 0
600 Rosuvastatin 17 0 0 0 17 0 0 0
601 Rosuvastatin and amlodipine 1 0 0 0 1 0 0 0
602 Rosuvastatin and valsartan 1 0 0 0 1 0 0 0
603 Rota virus, live attenuated 1 1 0 0 0 0 0 1
604 Rutoside, combinations 6 0 0 0 6 0 0 0
605 Sabalis serrulatae fructus 1 0 0 0 1 0 0 0
606 Saccharated iron oxide 12 0 0 0 12 0 0 0
607 Saccharomyces boulardii 3 0 0 0 3 0 0 0
608 Salbutamol 25 0 0 0 25 0 0 0
609 Salicylic acid 2 0 0 0 2 0 0 0
610 Salmeterol and fluticasone 3 0 0 0 3 0 0 0
611 Sanguiritrin* 1 0 0 0 1 0 0 0
612 Secnidazole 1 0 0 0 1 0 0 0
613 Serrapeptase* 20 0 0 0 20 0 0 0
614 Sertaconazole 5 0 0 0 5 0 0 0
615 Sertraline 4 0 0 0 3 0 1 0
616 Sildenafil 2 0 0 0 2 0 0 0
617 Silicium dioxide* 1 0 0 0 1 0 0 0
618 Silicones 10 0 0 0 10 0 0 0
619 Silodosin 2 0 0 0 2 0 0 0
620 Silymarin 9 0 0 0 9 0 0 0
621 Simvastatin 78 0 0 0 77 0 1 0
622 Sodium aminosalicylate 335 0 0 0 304 0 31 0
623 Sodium bicarbonate 1 0 0 0 1 0 0 0
624 Sodium chloride 40 0 0 8 11 16 5 0
625 Sodium citrate 1 0 0 0 1 0 0 0
626 Sodium oksodyhidroakrydynilatsetat (Cridanimod*) 1 0 0 0 1 0 0 0
627 Sodium oxybate 1 0 0 0 0 0 1 0
628 Sodium tetraborate* 1 0 0 0 1 0 0 0
629 Sofosbuvir and velpatasvir 1 0 0 0 1 0 0 0
630 Solidago virgaurea* 1 0 0 0 1 0 0 0
631 Solifenacin 1 0 0 0 1 0 0 0
632 Spiramycin 4 0 0 0 4 0 0 0
633 Spironolactone 54 0 0 0 53 0 1 0
634 Sulbutiamine 1 0 0 0 1 0 0 0
635 Sulfacetamide 7 0 0 0 7 0 0 0
636 Sulfadimethoxine 2 0 0 0 2 0 0 0
637 Sulfamethoxazole and trimethoprim 51 0 0 0 47 0 4 0
638 Sulfanilamide 3 0 0 0 2 0 1 0
639 Sulfasalazine 4 0 0 0 3 0 1 0
640 Sulfathiazole 2 0 0 0 2 0 0 0
641 Sulfocamphocain* 6 0 0 0 5 0 1 0
642 Sulfur 3 0 0 0 3 0 0 0
643 Sulpiride 15 0 0 0 15 0 0 0
644 Sumatriptan 1 0 0 0 1 0 0 0
645 Suxamethonium 10 0 0 0 1 0 9 0
646 Tacrolimus 2 0 0 0 2 0 0 0
647 Tamsulosin 9 0 0 0 9 0 0 0
648 Tamsulosin and dutasteride 1 0 0 0 1 0 0 0
649 Taurine* 2 0 0 0 2 0 0 0
650 Telmisartan 7 0 0 0 7 0 0 0
651 Telmisartan and diuretics 2 0 0 0 2 0 0 0
652 Tenecteplase 1 0 0 0 1 0 0 0
653 Tenofovir disoproxil 17 0 0 0 16 0 1 0
654 Tenofovir disoproxil and emtricitabine 134 0 0 0 111 0 23 0
655 Tenoxicam 6 0 0 0 6 0 0 0
656 Terbinafine 5 0 0 0 5 0 0 0
657 Terizidone 90 0 0 0 73 0 17 0
658 Tetanus immunoglobulin 1 0 0 0 1 0 0 0
659 Tetanus toxoid 2 1 0 0 1 0 1 0
660 Tetanus toxoid, combinations with diphtheria toxoid 178 3 0 0 171 0 5 2
661 Tetracycline 1 0 0 0 1 0 0 0
662 Theophylline 34 0 0 0 33 0 1 0
663 Theophylline, combinations excl. psycholeptics 13 0 0 0 13 0 0 0
664 Thiamazole 7 0 0 0 7 0 0 0
665 Thiamine (vit B1) 23 0 0 0 23 0 0 0
666 Thiocolchicoside 12 0 0 0 12 0 0 0
667 Thioctic acid 58 0 0 0 53 0 5 0
668 Thiopental 4 0 0 0 4 0 0 0
669 Thioridazine 5 0 0 0 5 0 0 0
670 Thiosulfate 9 0 0 0 8 0 1 0
671 Thiotriazolin* 1 0 0 0 1 0 0 0
672 Thymus serpyllum** 1 0 0 0 0 0 1 0
673 Tiazotic acid 50 0 0 0 48 0 2 0
674 Ticagrelor 17 0 0 0 16 0 1 0
675 Tilorone 20 0 0 0 19 0 1 0
676 Timolol 4 0 0 0 4 0 0 0
677 Timolol, combinations 11 0 0 0 11 0 0 0
678 Tizanidine 25 0 0 0 24 0 1 0
679 Tobramycin 8 0 0 0 8 0 0 0
680 Tolperisone 9 0 0 0 6 0 3 0
681 Topiramate 1 0 0 0 1 0 0 0
682 Torasemide 10 0 0 0 9 0 1 0
683 Toremifene 1 0 0 0 1 0 0 0
684 Tramadol 3 0 0 0 3 0 0 0
685 Tranexamic acid 29 0 0 0 29 0 0 0
686 Trastuzumab 2 0 0 0 2 0 0 0
687 Travoprost 4 0 0 0 4 0 0 0
688 Trazodone 8 0 0 0 8 0 0 0
689 Triamcinolone 1 0 0 0 1 0 0 0
690 Triamcinolone and antiseptics 2 0 0 0 2 0 0 0
691 Trifluoperazine 45 0 0 0 43 0 2 0
692 Trihexyphenidyl 2 0 0 0 2 0 0 0
693 Trimebutine 12 0 0 0 12 0 0 0
694 Trimetazidine 39 0 0 0 38 0 1 0
695 Troxerutin 5 0 0 0 5 0 0 0
696 Troxerutin, combinations 1 0 0 0 1 0 0 0
697 Tuberculosis, live attenuated 16 8 0 0 3 0 1 12
698 Tyrothricin 3 0 0 0 3 0 0 0
699 Umifenovir 4 0 0 0 4 0 0 0
700 Urapidil 5 0 0 0 5 0 0 0
701 Ursodeoxycholic acid 11 0 0 0 11 0 0 0
702 Valaciclovir 6 0 0 0 6 0 0 0
703 Valerianae radix 5 0 0 0 5 0 0 0
704 Validol* 5 0 0 0 5 0 0 0
705 Valproic acid 31 0 0 0 30 0 1 0
706 Valsartan 9 0 0 0 9 0 0 0
707 Valsartan and amlodipine 19 0 0 0 19 0 0 0
708 Valsartan and diuretics 15 0 0 0 15 0 0 0
709 Valsartan and sacubitril 1 0 0 0 1 0 0 0
710 Valsartan, amlodipine and hydrochlorothiazide 6 0 0 0 6 0 0 0
711 Vancomycin 29 0 0 0 26 0 3 0
712 Various 1 0 0 0 0 0 1 0
713 Venlafaxine 5 0 0 0 5 0 0 0
714 Verapamil 16 0 0 0 16 0 0 0
715 Vincamine 2 0 0 0 2 0 0 0
716 Vinpocetine 28 0 0 0 27 0 1 0
717 Viride nitens* 6 0 0 0 6 0 0 0
718 Vitamin B1 in combination with vitamin B6 and/or vitamin B12 128 0 0 0 124 0 4 0
719 Warfarin 10 0 0 0 9 0 1 0
720 Xantinol nicotinate 15 0 0 0 15 0 0 0
721 Xylometazoline 16 0 0 0 15 0 1 0
722 Yellow fever, live attenuated 1 0 0 0 1 0 0 0
723 Zidovudine 2 0 0 0 2 0 0 0
724 Zidovudine and lamivudine 146 0 0 0 138 0 8 0
725 Zoledronic acid 2 0 0 0 1 0 1 0
726 Zuclopenthixol 23 0 0 0 22 0 1 0
727 Unknown 385 0 0 0 320 0 65 0
Total 27161 75 3 12 24865 16 2192 73

 

Note: * <> – adverse events that coincided in time with vaccination/tuberculin diagnostics (administration of immunoglobulins) for which, as of 31.12.2018, no Investigation Protocols from regional rapid response groups have been received for 84 case(s)
ve – lack of efficacy of a medicinal product
nn – non-serious unexpected AR of a medicinal product
np – non-serious expected AR of a medicinal product
sn – serious unexpected AR of a medicinal product
sp – serious expected AR of a medicinal product
AEFI – adverse event following immunization

 

 

  1. DISTRIBUTION OF AR/NPPI OF MEDICINAL PRODUCTS BY CLASS OF DISEASES IN THE TREATMENT OF WHICH THEY WERE USED

Table 3

CLASSES OF DISEASES (ACCORDING TO ICD-10) IN THE TREATMENT OR PREVENTION OF WHICH ADVERSE REACTIONS/LACK OF EFFICACY OF MEDICINAL PRODUCTS WERE IDENTIFIED

 

No. Class Code Name of the disease class, according to ICD-10 Number of AR/NPPI %
1 I A00-B99 Certain infectious and parasitic diseases 11431 41,64%
2 II C00-D48 Neoplasms 180 0,66%
3 III D50-D89 Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism 74 0,27%
4 IV E00-E90 Endocrine, nutritional and metabolic diseases 371 1,35%
5 IX I00-I99 Diseases of the circulatory system 3035 11,06%
6 V F00-F99 Mental and behavioral disorders 706 2,57%
7 VI G00-G99 Diseases of the nervous system 371 1,35%
8 VII H00-H59 Diseases of the eye and adnexa 118 0,43%
9 VIII H60-H95 Diseases of the ear and mastoid process 90 0,33%
10 X J00-J99 Respiratory diseases 2971 10,82%
11 XI K00-K93 Diseases of the digestive system 896 3,26%
12 XII L00-L99 Diseases of the skin and subcutaneous tissue 232 0,85%
13 XIII M00-M99 Diseases of the musculoskeletal system and connective tissue 785 2,86%
14 XIV N00-N99 Diseases of the genitourinary system 685 2,50%
15 XIX S00-T98 Injury, poisoning and certain other consequences of external causes 218 0,79%
16 XV O00-O99 Pregnancy, childbirth and the postpartum period 209 0,76%
17 XVI P00-P96 Certain conditions originating in the perinatal period 9 0,03%
18 XVII Q00-Q99 Congenital malformations, deformations and chromosomal abnormalities 21 0,08%
19 XVIII R00-R99 Symptoms, signs and abnormal findings from laboratory and clinical examinations, not classified elsewhere 58 0,21%
20 XX V01-Y98 External causes of morbidity and mortality 23 0,08%
21 XXI Z00-Z99 Factors influencing the health status of the population and contact with health care facilities 2269 8,27%
22 Condition not classified under ICD-10 2699 9,83%
Total 27451 100,00 %

 

  1. DISTRIBUTION OF ARs/NPPIs BY COUNTRY OF MANUFACTURE OF THE MEDICINAL PRODUCT

Table 4

DISTRIBUTION OF AR/NPPI CASES OF MEDICINAL PRODUCTS BY MANUFACTURER'S COUNTRY

No. Country of manufacture Quantity %
1 Austria 126 0,46%
2 Belgium 211 0,77%
3 Belarus 54 0,20%
4 Bulgaria 188 0,68%
5 Bosnia and Herzegovina 11 0,04%
6 Great Britain 212 0,77%
7 Vietnam 2 0,01%
8 Armenia 7 0,03%
9 Greece 172 0,63%
10 Georgia 1 0,00%
11 Denmark 53 0,19%
12 Estonia 1 0,00%
13 Egypt 23 0,08%
14 Israel 15 0,05%
15 India 11623 42,34%
16 Indonesia 2 0,01%
17 Iran 76 0,28%
18 Ireland 25 0,09%
19 Iceland 5 0,02%
20 Spain 131 0,48%
21 Italy 272 0,99%
22 Jordan 77 0,28%
23 Canada 28 0,10%
24 Cyprus 77 0,28%
25 PRC 25 0,09%
26 Latvia 203 0,74%
27 Lithuania 3 0,01%
28 Macedonia 49 0,18%
29 Malta 43 0,16%
30 Netherlands 121 0,44%
31 Germany 846 3,08%
32 Norway 11 0,04%
33 Pakistan 4 0,01%
34 South Korea 44 0,16%
35 Poland 179 0,65%
36 Portugal 2 0,01%
37 Russia 62 0,23%
38 Romania 100 0,36%
39 Saudi Arabia 1 0,00%
40 Serbia 31 0,11%
41 Singapore 4 0,01%
42 Slovakia 18 0,07%
43 Slovenia 441 1,61%
44 USA 25 0,09%
45 Thailand 4 0,01%
46 Turkey 108 0,39%
47 Hungary 303 1,10%
48 Ukraine 10035 36,56%
49 Finland 23 0,08%
50 France 536 1,95%
51 Croatia 40 0,15%
52 Czech Republic 25 0,09%
53 Switzerland 65 0,24%
54 Sweden 28 0,10%
55 Japan 92 0,34%
56 Not determined 588 2,14%
Total 27451 100,00%

 

  1. DISTRIBUTION OF AR/NPPI OF MEDICINAL PRODUCTS BY SYSTEMIC MANIFESTATIONS

Table 5

SYSTEMIC MANIFESTATIONS OF AR/NPPI OF A MEDICINAL PRODUCT

 

No. Systems and organs Quantity %
1 General disorders and administration site conditions 6857 14,19%
2 Infections and infestations 64 0,13%
3 Congenital, hereditary and genetic disorders 3 0,01%
4 Examination 2833 5,86%
5 Mental disorders 1870 3,87%
6 Respiratory, thoracic and mediastinal disorders 1572 3,25%
7 Hepatobiliary disorders 494 1,02%
8 Endocrine disorders 10 0,02%
9 Immune system disorders 450 0,93%
10 Blood and lymphatic system disorders 487 1,01%
11 Nervous system disorders 6513 13,48%
12 Renal and urinary disorders 489 1,01%
13 Musculoskeletal and connective tissue disorders 1731 3,58%
14 Eye disorders 356 0,74%
15 Ear and labyrinth disorders 931 1,93%
16 Cardiac disorders 899 1,86%
17 Genital/reproductive system and breast disorders 122 0,25%
18 Vascular disorders 447 0,92%
19 Skin and subcutaneous tissue disorders 10194 21,09%
20 Metabolic and nutritional disorders 818 1,69%
21 Injuries, damage and procedural complications 77 0,16%
22 Gastrointestinal disorders 10878 22,51%
23 Not determined 232 0,48%
Total 48327 100,00%

 

  1. DISTRIBUTION OF ADRs/NPPI OF MEDICINAL PRODUCTS BY ESTABLISHED CAUSAL RELATIONSHIP, EXPECTEDNESS AND SERIOUSNESS

 

Table 6a

DISTRIBUTION OF AR/NPPI OF MEDICINAL PRODUCTS BY ESTABLISHED CAUSAL RELATIONSHIP

 

No. Causal relationship established Quantity %
1 Defined 3381 6,66%
2 Probable 24686 48,66%
3 Possible 22168 43,69%
4 Not classifiable 2 0,00%
5 Doubtful 56 0,11%
6 Conditional 2 0,00%
7 Not determined 440 0,87%
Total 50735 100,00%

 

Table 6b

DISTRIBUTION OF MANIFESTATIONS OF AR/NPPI OF MEDICINAL PRODUCTS BY EXPECTEDNESS

 

No. Expectedness of AR manifestations Quantity %
1 Provided 49809 98,17%
2 Unexpected 93 0,18%
3 Not specified 833 1,64%
Total 50735 100,00%

 

Table 6v

DISTRIBUTION OF ADR/AEFI OF MEDICINAL PRODUCTS BY REASON OF SERIOUSNESS

 

No. Reason for seriousness of the ADR case Quantity %
1 Life-threatening 474 21,55%
2 Patient death 28 1,27%
3 Hospitalization of an outpatient 431 19,59%
4 Extension of hospitalization periods 840 38,18%
5 Long-term disability 38 1,73%
6 Disability 35 1,59%
7 Other medically important health condition 354 16,09%
8 Congenital malformations 0 0,00%
Total 2200 100,00 %

 

Table 6d

DISTRIBUTION OF ADR/AEFI OF MEDICINAL PRODUCTS BY DEGREE OF SERIOUSNESS

 

No. Degree of seriousness Quantity %
1 Serious 2071 7,89%
2 Non-serious 24184 92,11%
Total 26255 100,00%

 

 

 

 

 

 

Table 6e

DATA ON CASES OF UNEXPECTED ADRs

 

No. MP Dosage form Manufacturer PR description
1 DIPROFOL® emulsion for injection 1% in 20 ml ampoules; 5 ampoules per blister; 1 blister per cardboard pack; 50 ml in a vial; 1 vial per cardboard pack PJSC “Farmak” (packaging from in bulk form of the manufacturer Synthon Hispania, S.L., Spain (at the production site of Fresenius Kabi Austria GmbH, Austria) During the surgical intervention, after the start of the infusion of Diprofol solution, marked hypertension (200-220/130-140 mm Hg), tachycardia up to 140-150 bpm, hyperthermia up to 38 °C, and skin manifestations in the form of facial and chest hyperemia were observed
2 LARNAMIN concentrate for solution for infusion, 500 mg/mL; 10 mL in an ampoule; 5 or 10 ampoules in a cardboard pack; 10 mL in an ampoule; 5 ampoules in a blister; 1 or 2 blisters in a cardboard pack PJSC “Farmak” After taking the medicinal product “Larnamin”, dizziness and palpitations appeared
3 METACARTIN solution for injection, 1 g/5 ml, 5 ml in an ampoule; 5 ampoules in a blister pack; 1 or 2 blister packs in a cardboard box Mefar Ilac San. A.S. Skin itching and skin rash
4 SODIUM CHLORIDE solution for infusion, 9 mg/mL, 100 mL or 200 mL or 400 mL in bottles; 100 mL or 200 mL or 250 mL or 400 mL or 500 mL or 1000 mL or 2000 mL or 3000 mL or 5000 mL in polymer containers LLC “Yuria-Pharm” increase in temperature to 38.6°C, chills, headache
5 SODIUM CHLORIDE solution for infusion, 9 mg/mL, 100 mL or 200 mL or 400 mL in bottles; 100 mL or 200 mL or 250 mL or 400 mL or 500 mL or 1000 mL or 2000 mL or 3000 mL or 5000 mL in polymer containers LLC “Yuria-Pharm” body temperature rise to 37.5°C, chills, general weakness, blood pressure increase 180/100 mm Hg
6 SODIUM CHLORIDE solution for infusion, 9 mg/mL, 100 mL or 200 mL or 400 mL in bottles; 100 mL or 200 mL or 250 mL or 400 mL or 500 mL or 1000 mL or 2000 mL or 3000 mL or 5000 mL in polymer containers LLC “Yuria-Pharm” body temperature increase to 39.2°C, chills, general weakness
7 SODIUM CHLORIDE solution for infusion, 9 mg/mL, 100 mL or 200 mL or 400 mL in bottles; 100 mL or 200 mL or 250 mL or 400 mL or 500 mL or 1000 mL or 2000 mL or 3000 mL or 5000 mL in polymer containers LLC “Yuria-Pharm” After intravenous infusion: general weakness, a rise in body temperature to 39.8 C and a drop in blood pressure.
8 SODIUM CHLORIDE solution for infusion, 9 mg/mL, 100 mL or 200 mL or 400 mL in bottles; 100 mL or 200 mL or 250 mL or 400 mL or 500 mL or 1000 mL or 2000 mL or 3000 mL or 5000 mL in polymer containers LLC “Yuria-Pharm” After administration of the drug, the patient developed: marked general weakness, headache, chills and a rise in body temperature to 39.0 C.
9 SODIUM CHLORIDE solution for infusion, 9 mg/mL, 100 mL or 200 mL or 400 mL in bottles; 100 mL or 200 mL or 250 mL or 400 mL or 500 mL or 1000 mL or 2000 mL or 3000 mL or 5000 mL in polymer containers LLC “Yuria-Pharm” After administration of the drug, the patient developed: headache and a rise in body temperature to 39.0 C.
10 SODIUM CHLORIDE solution for infusion, 9 mg/mL, 100 mL or 200 mL or 400 mL in bottles; 100 mL or 200 mL or 250 mL or 400 mL or 500 mL or 1000 mL or 2000 mL or 3000 mL or 5000 mL in polymer containers LLC “Yuria-Pharm” After administration of the medicinal product, the patient developed: headache, tremor and a rise in body temperature to 39.5 C.
11 SODIUM CHLORIDE solution for infusion, 9 mg/mL, 100 mL or 200 mL or 400 mL in bottles; 100 mL or 200 mL or 250 mL or 400 mL or 500 mL or 1000 mL or 2000 mL or 3000 mL or 5000 mL in polymer containers LLC “Yuria-Pharm” After administration of the drug, the patient developed: headache, tremor, body temperature increase to 39,5 C and nausea.
12 SODIUM CHLORIDE solution for infusion, 9 mg/mL, 100 mL or 200 mL or 400 mL in bottles; 100 mL or 200 mL or 250 mL or 400 mL or 500 mL or 1000 mL or 2000 mL or 3000 mL or 5000 mL in polymer containers LLC “Yuria-Pharm” After administration of the medicinal product, the patient developed general weakness, headache, chills and a rise in body temperature to 39.0 C.
13 SODIUM CHLORIDE solution for infusion, 9 mg/mL, 100 mL or 200 mL or 400 mL in bottles; 100 mL or 200 mL or 250 mL or 400 mL or 500 mL or 1000 mL or 2000 mL or 3000 mL or 5000 mL in polymer containers LLC “Yuria-Pharm” After administration of the medicinal product, the patient developed general weakness, headache, chills and a rise in body temperature to 40.0 C.
14 SODIUM CHLORIDE solution for infusion, 9 mg/mL, 100 mL or 200 mL or 400 mL in bottles; 100 mL or 200 mL or 250 mL or 400 mL or 500 mL or 1000 mL or 2000 mL or 3000 mL or 5000 mL in polymer containers LLC “Yuria-Pharm” After administration of the drug, the patient developed: general weakness, headache, tremor, chills and a rise in body temperature to 38.6 C.
15 SODIUM CHLORIDE solution for infusion, 9 mg/mL, 100 mL or 200 mL or 400 mL in bottles; 100 mL or 200 mL or 250 mL or 400 mL or 500 mL or 1000 mL or 2000 mL or 3000 mL or 5000 mL in polymer containers LLC “Yuria-Pharm” After administration of the medicinal product, the patient developed general weakness, headaches, chills and a rise in body temperature to 39.0 C.
16 SODIUM CHLORIDE solution for infusion, 9 mg/mL, 100 mL or 200 mL or 400 mL in bottles; 100 mL or 200 mL or 250 mL or 400 mL or 500 mL or 1000 mL or 2000 mL or 3000 mL or 5000 mL in polymer containers LLC “Yuria-Pharm” After administration of the drug, the patient developed chills and a rise in body temperature to 39.4 C.
17 SODIUM CHLORIDE solution for infusion, 9 mg/mL, 100 mL or 200 mL or 400 mL in bottles; 100 mL or 200 mL or 250 mL or 400 mL or 500 mL or 1000 mL or 2000 mL or 3000 mL or 5000 mL in polymer containers LLC “Yuria-Pharm” skin redness, difficulty breathing, increased BP 220/100 mm Hg
18 SODIUM CHLORIDE solution for infusion, 9 mg/mL, 100 mL or 200 mL or 400 mL in bottles; 100 mL or 200 mL or 250 mL or 400 mL or 500 mL or 1000 mL or 2000 mL or 3000 mL or 5000 mL in polymer containers LLC “Yuria-Pharm” itching, redness of the entire trunk
19 SODIUM CHLORIDE solution for infusion, 9 mg/mL, 100 mL, or 200 mL, or 250 mL, or 400 mL, or 500 mL in a bottle; 1 bottle in a cardboard box; 100 mL, 200 mL or 250 mL, or 400 mL, or 500 mL in bottles Limited Liability Company firm "Novofarm-Biosyntez" increase in body temperature to 39,5 C, increased blood pressure (170/100 mm Hg) , tremor, chills
20 SODIUM CHLORIDE solution for infusion, 9 mg/mL, 100 mL, or 200 mL, or 250 mL, or 400 mL, or 500 mL in a bottle; 1 bottle in a cardboard box; 100 mL, 200 mL or 250 mL, or 400 mL, or 500 mL in bottles Limited Liability Company firm "Novofarm-Biosyntez" increase in body temperature to 39,5 C, increased blood pressure (180 mm Hg), tremor, chills
21 SODIUM CHLORIDE SOLUTION 0,9 % solution for infusion 0,9% in 100 ml, or 200 ml, or 250 ml, or 400 ml, or 500 ml in bottles Private Joint-Stock Company “Infuzia” 02.08.2019 during intravenous drip infusion of 150 ml of the medicinal product Sodium Chloride, the child developed manifestations of an AR: body temperature rise to 40,7° C, chills. The infusion therapy was discontinued. The manifestations of the AR disappeared after withdrawal of the suspected medicinal product and administration of drug therapy to eliminate the manifestations of the AR: Analgin 0,5 ml and Papaverine 0,5 ml were administered intramuscularly. Other concomitant therapy was continued in subsequent treatment without adverse consequences.
22 SODIUM CHLORIDE SOLUTION 0,9 % solution for infusion 0,9% in 100 ml, or 200 ml, or 250 ml, or 400 ml, or 500 ml in bottles Private Joint-Stock Company “Infuzia” 03.08.2019 during intravenous drip administration of 200 ml of the medicinal product Sodium chloride, the patient developed adverse reaction manifestations: body temperature increased to 38,9° C, fine tremor, lethargy, acrocyanosis, extremities cool to the touch. Infusion therapy was discontinued. The adverse reaction manifestations resolved within an hour after withdrawal of the suspected medicinal product and administration of drug therapy to eliminate the manifestations: Analgin 0,8 ml, Papaverine 0,8 ml, Diphenhydramine 0,8 ml were administered intramuscularly. Other concomitant therapy was continued in subsequent treatment without adverse consequences. increase in body temperature to 38,9 C, lethargy, acrocyanosis, tremor
23 SODIUM CHLORIDE SOLUTION 0,9 % solution for infusion 0,9% in 100 ml, or 200 ml, or 250 ml, or 400 ml, or 500 ml in bottles Private Joint-Stock Company “Infuzia” 03.08.2019 during intravenous drip infusion of 50 ml of the medicinal product Sodium chloride, the patient developed manifestations of an adverse reaction: body temperature rise to 39,8°C, chills, dyspnea, tachycardia, acrocyanosis, pallor of the skin and mucous membranes. The infusion therapy was stopped. The manifestations of the adverse reaction disappeared within an hour after withdrawal of the suspected medicinal product and administration of drug therapy to eliminate them: Suprastin 0,4 ml and dexazon 0,5 ml were administered i.m. Other concomitant therapy was continued afterwards without adverse consequences.
24 SODIUM CHLORIDE SOLUTION 0,9 % solution for infusion 0,9% in 100 ml, or 200 ml, or 250 ml, or 400 ml, or 500 ml in bottles Private Joint-Stock Company “Infuzia” 03.08.2019 during an intravenous drip infusion of 200 mL of Sodium Chloride medicinal product, the child developed manifestations of an AR: body temperature rose to 39,4° C, chills, restlessness, pallor of the skin and mucous membranes. The extremities were cool to the touch. The infusion therapy was stopped. The manifestations of the AR disappeared after withdrawal of the suspected medicinal product and administration of drug therapy to eliminate the manifestations of the AR. Other concomitant therapy was continued in subsequent treatment without negative consequences.
25 SODIUM CHLORIDE SOLUTION 0,9 % solution for infusion 0,9% in 100 ml, or 200 ml, or 250 ml, or 400 ml, or 500 ml in bottles Private Joint-Stock Company “Infuzia” Headache, general weakness, chills, increase in body temperature (t) to 39,2C
26 SODIUM CHLORIDE SOLUTION 0,9 % solution for infusion 0,9% in 100 ml, or 200 ml, or 250 ml, or 400 ml, or 500 ml in bottles Private Joint-Stock Company “Infuzia” General weakness, chills, increase in body temperature to 39,4C
27 SODIUM CHLORIDE SOLUTION 0,9 % solution for infusion 0,9% in 100 ml, or 200 ml, or 250 ml, or 400 ml, or 500 ml in bottles Private Joint-Stock Company “Infuzia” Body temperature increase to 40C, general weakness
28 RINGER'S SOLUTION solution for infusion, 200 ml or 400 ml in bottles Private Joint-Stock Company “Infuzia” Trembling and a feeling of heat in the body, body temperature rising to 38 degrees

 

  1. INFORMATION ON FATAL CASES OF ARs TO MEDICINAL PRODUCTS AND AEFIs (FATAL CASES)

Table 7a

CASES OF ADRs TO MEDICINAL PRODUCTS THAT RESULTED IN DEATH

 

No. Age Sex Suspected medicinal products PR description Diagnosis/Indications
1 44 yr. M DEXAMETHASONE severe shortness of breath, diffuse cyanosis of the upper half of the trunk, loss of consciousness J44.8 Other specified chronic obstructive pulmonary disease
MUCOSOL severe shortness of breath, diffuse cyanosis of the upper half of the trunk, loss of consciousness J44.8 Other specified chronic obstructive pulmonary disease
SODIUM CHLORIDE severe shortness of breath, diffuse cyanosis of the upper half of the trunk, loss of consciousness J44.8 Other specified chronic obstructive pulmonary disease
SODIUM CHLORIDE severe shortness of breath, diffuse cyanosis of the upper half of the trunk, loss of consciousness J44.8 Other specified chronic obstructive pulmonary disease
PROMOCEF® severe shortness of breath, diffuse cyanosis of the upper half of the trunk, loss of consciousness J44.8 Other specified chronic obstructive pulmonary disease
2 40 yr. F LIDOCAINE-DARNYTSIA after paracervical administration of a lidocaine solution, the patient complained of dizziness and lost consciousness, blood pressure was undetectable, breathing was absent, pulse in the carotid artery was undetectable, the skin was pale, with cyanosis of the face, tonic-clonic seizures pain relief
SODIUM CHLORIDE after paracervical administration of a lidocaine solution, the patient complained of dizziness and lost consciousness, blood pressure was undetectable, breathing was absent, pulse in the carotid artery was undetectable, the skin was pale, with cyanosis of the face, tonic-clonic seizures solvent
3 44 yr. F CEFTRIAXONE-BKhFZ On 16.03.2019 at 11 o'clock, intravenous administration of the suspected medicinal product Ceftriaxone-BCFZ in 10 mL of water for injection was started; almost immediately (approximately 0,5 mL had been administered) the patient suddenly lost consciousness. The nurse administered 0,5 mL of adrenaline solution and 2 mL of dexamethasone. The head of the outpatient clinic of general practice and family medicine was called; she established cardiac arrest and began cardiopulmonary resuscitation. A resuscitation team was called from the district hospital. Resuscitation measures were carried out for an hour, but without effect. At 12 o'clock, 16.03.2019, biological death of a woman born in 1974 was pronounced. J45.9 Asthma, unspecified
4 54 yr. F METONAT after administration of Methonat, the patient developed swelling of the face and lips, cyanosis of the skin of the face, trunk, and especially the extremities, a drop in blood pressure to 0 mm Hg, and loss of consciousness I67.4 Hypertensive encephalopathy
5 60 yr. M TOMOHEXOL® During diagnostic arteriography, at minute 5 of intra-arterial jet injection of the contrast agent Tomohexol 50.0 ml, the patient developed a sharp drop in blood pressure and asystole. The patient had previously been given analgesia: analgin solution 50%-2.0 ml; diphenhydramine solution 1%-1.0 intravenous jet; novocaine solution 0.5%-5.0 subcutaneously. To eliminate the manifestations of the adverse reaction, cardiopulmonary resuscitation was carried out for 40 min, namely: artificial lung ventilation, closed cardiac massage, intravenous administration of 0,18 % Adrenaline solution in Sodium chloride solution 0,9%, and dexamethasone. Sinus rhythm was restored, but against a background of persistent hypotension, despite repeated administration of adrenaline, dexamethasone, and atropine, the patient developed asystole again. Resuscitation measures were ineffective. On 03.06.2019 at 13 h 30 min, biological death of the man, born in 1959, was declared. I70.2 Atherosclerosis of the arteries of the extremities
6 59 yr. M ULTRAVIST 370 During balloon angioplasty, under combined anesthesia with intravenous administration of fentanyl 1.0 and subcutaneous administration of novocaine solution 0.5%-20.0, the right common femoral artery was catheterized and a catheter was advanced to the left subclavian artery with administration of Ultravist 370-30.0. 3-5 min after the administration of Ultravist, the patient developed pronounced general weakness and persistent hypotension. Emergency care was started: epinephrine 1 mg every 5 min, dexamethasone 8 mg, infusion of mesatone 180 mg/kg, dopamine 10 mcg/kg/min. Despite the therapy, persistent hypotension remained, ventricular fibrillation occurred, and defibrillation, indirect cardiac massage and intubation were performed. Despite the measures taken, biological death was declared at 15.05. I70.2 Atherosclerosis of the arteries of the extremities
7 20 yr. F ARTYFRYN-ZDOROV'YA FORTE Anaphylactic reaction manifested clinically by nausea, vomiting, a drop in blood pressure, a barking cough, and general weakness
8 32 yr. M INGALIPT-ZDOROVIA After inhalation of Ingalipt, gradually increasing suffocation began, and a choking cough appeared J06.9
9 22 yr. F LIDOCAINE-DARNYTSIA anaphylactic shock, asystole, post-resuscitation disease N10 Acute tubulointerstitial nephritis
CEFTRIAXONE anaphylactic shock, asystole, post-resuscitation disease N10 Acute tubulointerstitial nephritis
10 25 yr. F ATRACURIUM-NOVO Arterial hypotension, sinus tachycardia Q18.8 Median cyst of the neck
DIPROFOL® Arterial hypotension, sinus tachycardia Q18.8 Median cyst of the neck
DITILIN-BIOLIK Arterial hypotension, sinus tachycardia Q18.8 Median cyst of the neck
11 41 yr. F ATRACURIUM-NOVO Rhabdomyolysis, distributive shock, multiple organ failure, death induction, maintenance of anesthesia
DIPROFOL® Rhabdomyolysis, distributive shock, multiple organ failure, death induction, maintenance of anesthesia
DIPROFOL® Rhabdomyolysis, distributive shock, multiple organ failure, death induction, maintenance of anesthesia
DITYLIN-DARNYTSIA Rhabdomyolysis, distributive shock, multiple organ failure, death induction, maintenance of anesthesia
SIBAZON Rhabdomyolysis, distributive shock, multiple organ failure, death induction, maintenance of anesthesia
FENTANYL KALCEKS Rhabdomyolysis, distributive shock, multiple organ failure, death induction, maintenance of anesthesia

 

Table 7b

AEFI CASES (FATAL CASES) REGISTERED FOLLOWING THE USE OF VACCINES AND TEMPORALLY ASSOCIATED WITH VACCINATION

 

No. Age Sex Suspected medicinal products NPPI description Diagnosis/Indications
1 3 mo. F VACCINE FOR THE PREVENTION OF DIPHTHERIA, TETANUS AND PERTUSSIS, ADSORBED, WITH C Mechanical asphyxia. Accidental strangulation and suffocation in bed Z27.1 Necessity of immunization against diphtheria, tetanus, and pertussis
CONJUGATE VACCINE FOR THE PREVENTION OF DISEASES CAUSED BY HAE Mechanical asphyxia. Accidental strangulation and suffocation in bed Z25.8 Need for immunization against HIB infection
2 6 mo. M INFANRIX HEXA™/INFANRIX HEXA™ COMBINED VACCINE FOR THE PREVENTION OF D Multiple organ failure. Other disorders of lipoprotein metabolism, ICD-10 code E93.8; Other significant (background) conditions – Other specified lesions of the brain. Z27 – Need for immunization against diphtheria, tetanus, pertussis, poliomyelitis, viral hepatitis B and HIB infection
3 1 mo. M BCG VACCINE, LYOPHILIZED /BCG VACCINE FREEZE-DRIED Influenza A (H1N1). Viral serous-desquamative bronchopneumonia. Intoxication of the body. Z23.2 Need for immunization against tuberculosis
4 1 mo. M BCG VACCINE, LYOPHILIZED /BCG VACCINE FREEZE-DRIED R95 Sudden infant death Z23.2 Need for immunization against tuberculosis
5 25 days M BCG VACCINE, LYOPHILIZED /BCG VACCINE FREEZE-DRIED Acute respiratory viral infection Z23.2 Need for immunization against tuberculosis
6 6 mo. F EUVAX B VACCINE FOR THE PREVENTION OF HEPATITIS B, RECOMBINANT LIQUID Sudden death of an infant with signs of respiratory failure Z24.6 Need for immunization against viral hepatitis B
IMOVAX POLIO VACCINE FOR THE PREVENTION OF POLIOMYELITIS, INACTIVATED, LIQUID Sudden death of an infant with signs of respiratory failure Z24.0 Need for immunization against poliomyelitis
7 3 mo. M VACCINE FOR THE PREVENTION OF DIPHTHERIA, TETANUS AND PERTUSSIS, ADSORBED, WITH C Cerebral edema of unknown etiology Z27.1 Necessity of immunization against diphtheria, tetanus, and pertussis
EUVAX B VACCINE FOR THE PREVENTION OF HEPATITIS B, RECOMBINANT LIQUID Cerebral edema of unknown etiology Z24.6 Need for immunization against viral hepatitis B
8 2 mo. M VACCINE FOR THE PREVENTION OF DIPHTHERIA, TETANUS AND PERTUSSIS, ADSORBED, WITH C Mechanical asphyxia due to aspiration of gastric contents. Z27.1 Necessity of immunization against diphtheria, tetanus, and pertussis
IMOVAX POLIO VACCINE FOR THE PREVENTION OF POLIOMYELITIS, INACTIVATED, LIQUID Mechanical asphyxia due to aspiration of gastric contents. Z24.0 Need for immunization against poliomyelitis
9 14 days F BCG VACCINE, LYOPHILIZED /BCG VACCINE FREEZE-DRIED Congenital heart defect. Coarctation of the aorta. Ventricular septal defect. Fibroelastosis Z23.2 Need for immunization against tuberculosis
EUVAX B VACCINE FOR THE PREVENTION OF HEPATITIS B, RECOMBINANT LIQUID Congenital heart defect. Coarctation of the aorta. Ventricular septal defect. Fibroelastosis Z24.6 Need for immunization against viral hepatitis B
10 1 mo. M BCG VACCINE, LYOPHILIZED /BCG VACCINE FREEZE-DRIED Pneumonia. Respiratory failure. Z23.2 Need for immunization against tuberculosis
11 1 yr. F M-M-R II MEASLES, MUMPS AND RUBELLA VIRUS VACCINE, LIVE / M-M-R® II MEASLES, MUMPS AND RUBELLA VIRUS VACCINE, LIVE Dilated cardiomyopathy ICD 10 – I 40.2 Z27.4 Necessity of immunization against measles, mumps, and rubella
12 8 mo. F VACCINE FOR THE PREVENTION OF DIPHTHERIA, TETANUS AND PERTUSSIS, ADSORBED, WITH C Bilateral polysegmental pneumonia. Multiple organ failure. Post-vaccination period: V3 “DTP,” V3 “Euvax B,” V2 Hib, V3 OPV (11.04.2019). Z27.1 Necessity of immunization against diphtheria, tetanus, and pertussis
CONJUGATE VACCINE FOR THE PREVENTION OF DISEASES CAUSED BY HAE Bilateral polysegmental pneumonia. Multiple organ failure. Post-vaccination period: V3 “DTP,” V3 “Euvax B,” V2 Hib, V3 OPV (11.04.2019). Z25.8 Need for immunization against HIB infection
EUVAX B VACCINE FOR THE PREVENTION OF HEPATITIS B, RECOMBINANT LIQUID Bilateral polysegmental pneumonia. Multiple organ failure. Post-vaccination period: V3 “DTP,” V3 “Euvax B,” V2 Hib, V3 OPV (11.04.2019). Z24.6 Need for immunization against viral hepatitis B
POLIO SABIN™ ONE AND THREE (ORAL) BIVALENT VACCINE FOR THE PREVENT Bilateral polysegmental pneumonia. Multiple organ failure. Post-vaccination period: V3 “DTP,” V3 “Euvax B,” V2 Hib, V3 OPV (11.04.2019). Z24.0 Need for immunization against poliomyelitis
13 1 mo. M BCG VACCINE, LYOPHILIZED /BCG VACCINE FREEZE-DRIED mechanical asphyxia due to aspiration of gastric contents Z23.2 Need for immunization against tuberculosis
14 7 days M BCG VACCINE, LYOPHILIZED /BCG VACCINE FREEZE-DRIED Congenital sepsis: meningoencephalitis, bilateral focal pneumonia, hepatitis (ICD-10 code P 36.9). Complications of the main diagnosis: Multiple organ failure: respiratory distress syndrome (hemorrhagic pulmonary edema), marked dystrophy of the liver and kidneys. DIC syndrome. Cerebral edema and swelling. Z23.2 Need for immunization against tuberculosis
15 5 yr. F M-M-R II VACCINE AGAINST MEASLES, MUMPS AND RUBELLA, VIRAL, LIVE / M-M- ICD code: A 41.9 Sepsis: purulent meningoencephalitis, bilateral focal pneumonia. Immunodeficiency. Venous congestion and dystrophy of parenchymal organs. Cerebral edema and swelling. Z27.4 Necessity of immunization against measles, mumps, and rubella
16 9 mo. M VACCINE FOR THE PREVENTION OF DIPHTHERIA, TETANUS AND PERTUSSIS, ADSORBED, WITH C cannot be classified due to the absence of the final conclusion of the forensic medical examination with the results of histological studies Z27.1 Necessity of immunization against diphtheria, tetanus, and pertussis
17 1 mo. F BCG VACCINE, LYOPHILIZED /BCG VACCINE FREEZE-DRIED acute cardiopulmonary failure, bilateral serous-hemorrhagic pneumonia Z23.2 Need for immunization against tuberculosis
18 4 mo. F ROTARIX™/ROTARIX™ VACCINE FOR THE PREVENTION OF ROTAVIRUS INFECTION R95 Sudden infant death preventive vaccination
19 3 mo. F HEXAXIM® / HEXAXIM VACCINE FOR THE PREVENTION OF DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR COMPONENT), HEPATITIS B RECOMBINANT, POLIOMYELITIS INACTIVATED AND DISEASES CAUSED BY HAEMOPHILUS TYPE B, CONJUGATED, ADSORBED, LIQUID Aspiration of stomach contents Z27 – need for immunization against diphtheria, tetanus, pertussis, poliomyelitis, viral hepatitis B and HIB infection

 

  1. DEPENDENCE OF THE OCCURRENCE OF ADRs/AEFIs ON THE START OF TREATMENT AND THE ADMINISTRATION OF IMMUNOPROPHYLAXIS

 

 

Figure 1. DEVELOPMENT OF AR/NPPI DEPENDING ON THE DURATION OF TREATMENT WITH MEDICINAL PRODUCTS

 

 

  1. DISTRIBUTION OF ARs/NPPIs BY ROUTE OF ADMINISTRATION

Figure 2. DISTRIBUTION OF AR/NPPI DEPENDING ON THE ROUTE OF ADMINISTRATION OF MEDICINAL PRODUCTS

 

  1. DISTRIBUTION OF OCCURRENCE OF ADRs/AEFIs OF MEDICINAL PRODUCTS BY GENDER AND AGE CHARACTERISTICS

Table 8

GENDER AND AGE CHARACTERISTICS OF DEVELOPMENT OF ARs/NPPIs OF MEDICINAL PRODUCTS

Children
Age girls boys unknown
  Quantity % Quantity % Quantity %
0-27 days 15 0,06 % 21 0,08 % 2 0,01 %
28 days-23 months 862 3,28 % 891 3,39 % 50 0,19 %
2-11 years 758 2,89 % 837 3,19 % 44 0,17 %
12-17 years 236 0,90 % 192 0,73 % 10 0,04 %
Total 1871 7,13 % 1941 7,39 % 106 0,40 %

 

Adults
Age, years women men unknown
  Quantity % Quantity % Quantity %
18-30 1404 5,35 % 1239 4,72 % 53 0,20 %
31-45 2952 11,24 % 4355 16,59 % 134 0,51 %
46-60 2743 10,45 % 3378 12,87 % 149 0,57 %
61-72 2240 8,53 % 1483 5,65 % 79 0,30 %
73-80 838 3,19 % 397 1,51 % 33 0,13 %
more than 80 533 2,03 % 192 0,73 % 22 0,08 %
Total 10710 40,79 % 11044 42,06 % 470 1,79 %

 

Age unknown
Age, years women men unknown
  Quantity % Quantity % Quantity %
– 48 0,18 % 53 0,20 % 12 0,05 %
Total 48 0,18 % 53 0,20 % 12 0,05 %

 

  1. DEPENDENCE OF THE OCCURRENCE OF ARs/AEFIs ON THE NUMBER OF MEDICINAL PRODUCTS USED (CMPs – concomitant medicinal products)

 

Figure 3. DEPENDENCE OF THE OCCURRENCE OF AR/NPPI ON THE NUMBER OF MEDICINAL PRODUCTS USED

  1. RESULTS OF THE WORK OF THE CENTER’S REPRESENTATIVES ON PHARMACOVIGILANCE (PV) IN ADMINISTRATIVE-TERRITORIAL UNITS

Table 9

DYNAMICS OF KEY PERFORMANCE INDICATORS

Measures taken Number of events

 

Number of conferences, seminars and meetings on pharmacovigilance issues held at the level of regional health departments by representatives of the Center on pharmacovigilance issues in the regions 978
Number of seminars on pharmacovigilance issues in healthcare facilities conducted by representatives of the Center on pharmacovigilance issues in the regions 1407
Number of scientific and practical conferences in which representatives of the Center took part and gave presentations on pharmacovigilance issues in the regions 118
Number of published scientific articles, informational letters and methodological recommendations in specialized scientific publications on pharmacovigilance issues by the Center’s representatives on pharmacovigilance issues in the regions 160
Number of published scientific articles, information letters, methodological recommendations in specialized publications and popular articles, information letters in central and local press and online publications, appearances on radio and television on pharmacovigilance issues 297
Number of individual visits to heads and doctors of healthcare facilities on pharmacovigilance issues 3641
Number of healthcare facilities submitting reports on adverse reactions and/or lack of efficacy of medicinal products 1699

(68,4%)