In accordance with paragraph 8 of Section IV of the Procedure for Conducting Expert Evaluation, the applicant must make amendments to the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information about the medicinal product corresponds to current scientific knowledge.
Having considered the available evidence, including additional information provided by the registration certificate holder (RCH) regarding the risk of medication errors associated with accidental overdose in children and adolescents, PRAC decided that all RCHs of medicinal products containing risperidone [oral solution] must provide dosing devices with clearly visible markings at 0,25 mL intervals.
Smaller intervals, for example 0,05 mL, should be marked with lines, but they do not necessarily need to be labeled with numbers.
RCHs must include clear instructions together with illustrations in the instructions for medical use in order to teach patients and caregivers to measure volumes correctly, especially small ones. Owing to the variability of dosing devices for different medicinal products, no uniform schemes can be recommended in this procedure.
Each RCH must introduce appropriate illustrations corresponding to the specific dosing device supplied with its medicinal product containing risperidone [oral solution].
TO ANALYZE THE PUBLISHED INFORMATION AND SUBMIT THE RELEVANT APPLICATION FOR AMENDMENTS TO THE REGISTRATION MATERIALS, THE APPLICANT MUST USE THE ORIGINAL TEXT AVAILABLE AT THE FOLLOWING LINKS:
