国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Vi polysaccharide of salmonella typhi; Hepatitis a virus
Sanofi Pasteur
J07CA; J07CA10
Vi polysaccharide of salmonella typhi; Hepatitis a virus
160/25
Solution and suspension for suspension for injection in pre-filled syringe
Product subject to prescription which may not be renewed (A)
Bacterial and viral vaccines, combined; typhoid-hepatitis A
Not marketed
2003-05-16
Health Products Regulatory Authority 15 February 2021 CRN00C081 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ViATIM, Suspension and solution for suspension for injection in pre-filled syringe. Hepatitis A (inactivated, adsorbed) and Typhoid polysaccharide vaccine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The dual-chamber syringe contains 0.5 millilitre of inactivated hepatitis A vaccine and 0.5 millilitre of typhoid polysaccharide vaccine which are mixed prior to administration. After reconstitution, 1 dose (1ml) contains: Originally contained in the suspension: Hepatitis A virus, GBM strain (inactivated) 1,2 ………….160 U 3 1 produced in human diploid (MRC-5) cells 2 adsorbed on aluminium hydroxide, hydrated (0.3 milligrams Al) 3 In the absence of an international standardised reference, the antigen content is expressed using an in-house reference Originally contained in the solution: Salmonella typhi (Ty 2 strain) capsular Vi polysaccharide………25 micrograms Excipient(s) with known effect (see Section 4.4): Phenylalanine………………10 micrograms For the full list of excipients, see section 6.1. ViATIM may contain traces of neomycin, which is used during the manufacturing process (see section 4.3). 3 PHARMACEUTICAL FORM Suspension and solution for suspension for injection in pre-filled syringe. The inactivated hepatitis A vaccine is a cloudy and white suspension and the typhoid polysaccharide vaccine is a clear and colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ViATIM is indicated for simultaneous active immunisation against typhoid fever and hepatitis A virus infection in subjects from 16 years of age. ViATIM should be given in accordance with official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dosagefor subjects of at least 16 years of age is 1 millilitre of the mixed vaccine. Initial protection is achieved with one single dose of ViATIM. Protective levels of antibody may not be reached until 14 完全なドキュメントを読む