According to the State Register of Medicinal Products, the vaccine for the prevention of diphtheria, tetanus, pertussis, hepatitis B, and diseases caused by Haemophilus influenzae type b, conjugated, adsorbed (hereinafter – DTP-Hib-HepB), manufactured by Serum Institute of India Pvt. Ltd., India, was registered in Ukraine 16.04.2019 (registration certificate UA/17318/01/01).
The DTP-Hib-HepB vaccine with this antigenic composition has not been used in Ukraine. This vaccine is a suspension that must be shaken thoroughly before use. According to the information given in the instruction for medical use, the preferred injection site for the DTP-Hib-HepB vaccine is the anterolateral part of the thigh, or the deltoid muscle for older children. According to the recommendations of the World Health Organization (WHO), the injection site for children under 3 years of age is the anterolateral part of the thigh, and for those over 3 years it is the deltoid muscle. Unacceptable is the injection of the DTP-Hib-HepB vaccine into the gluteal muscle, as this may cause damage to the sciatic nerve.
It is prohibited to administer the DTP-Hib-HepB vaccine subcutaneously or intravenously. The route of administration of the DTP-Hib-HepB vaccine is intramuscular only.
The DTP-Hib-HepB vaccine should not be mixed in a vial or syringe with other vaccines unless it is licensed for use as a combination product.
Before administering the DTP-Hib-HepB vaccine, the vaccine vial should be inspected for any foreign particles and/or deviations in physical properties. If there are any deviations, do not use the vaccine; dispose of it.
Before administering the DTP-Hib-HepB vaccine to a child, a medical examination by a doctor and temperature measurement must be performed, and the contraindications specified in the package leaflet must also be taken into account.
In accordance with generally accepted immunization rules, after vaccination the child must be monitored for 30 min. in a medical facility in order to provide timely emergency medical care in case of an immediate-type allergic reaction.
The type and intensity of severe adverse reactions do not differ significantly from the reactions to the combined vaccine against pertussis, diphtheria and tetanus (DTP), the hepatitis B monovaccine and the vaccine against diseases caused by haemophilus influenzae type b, which are described separately.
The most common adverse reactions after administration of the DTP-Hib-HepB vaccine are changes at the injection site (pain, swelling, hyperemia, infiltrate), which usually occur in the first 72 hours after immunization, and an increase in body temperature, which occurs within 48 hours after immunization. The list of possible adverse reactions can be found in the section “Adverse reactions” of the package insert for medical use.
The package leaflet for the DTP-Hib-HepB vaccine, approved by MoH order No. 859 of 16.04.2019, is available at http://www.drlz.com.ua/.
After immunization, parents must be advised to seek medical care if any health problems appear in the child within 30 days after vaccination.
If adverse reactions and/or adverse events following immunization/tuberculin diagnostics develop, the physician should notify the State Expert Center of the Ministry of Health of Ukraine by completing a report form. The report form, in paper and/or electronic format, can be found at https://dec.gov.ua/materials/medichnim-ta-farmaczevtichnim-praczivnikam/?role=doctors. We remind you that from 2017, the report form can be submitted quickly and conveniently through the automated pharmacovigilance information system (AISF) https://aisf.dec.gov.ua/Account/LogOn.
