ViATIM, Suspension and solution for suspension for injection in pre-filled syringe. Hepatitis A (inactivated, adsorbed) and Typhoid polysaccharide vaccine

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Vi polysaccharide of salmonella typhi; Hepatitis a virus

Disponibil de la:

Sanofi Pasteur

Codul ATC:

J07CA; J07CA10

INN (nume internaţional):

Vi polysaccharide of salmonella typhi; Hepatitis a virus

Dozare:

160/25

Forma farmaceutică:

Solution and suspension for suspension for injection in pre-filled syringe

Tip de prescriptie medicala:

Product subject to prescription which may not be renewed (A)

Zonă Terapeutică:

Bacterial and viral vaccines, combined; typhoid-hepatitis A

Statutul autorizaţiei:

Not marketed

Data de autorizare:

2003-05-16

Caracteristicilor produsului

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