VIVAXIM

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

HEPATITIS A IMMUNOGLOBULIN HUMAN; SALMONELLA TYPHI-IMMUNOGEN

Tersedia dari:

AVENTIS PHARMA - Indonesia

INN (Nama Internasional):

HEPATITIS A IMMUNOGLOBULIN HUMAN; SALMONELLA TYPHI-IMMUNOGEN

Bentuk farmasi:

CAIRAN INJEKSI

Unit dalam paket:

DUS, 1 SYRINGE @ 1 DOSIS (0,5 mL)

Diproduksi oleh:

SANOFI PASTEUR - France

Tanggal Otorisasi:

2016-06-21

Karakteristik produk

VIVAXIM
COMBINED TYPHOID (PURIFIED Vi
POLYSACCHARIDE) AND HEPATITIS A
(INACTIVATED) VACCINE
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 (1 mL) 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 milligram 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 (Ty2 strain) capsular Vi polysaccharides
...............................................25 micrograms
Excipient(s) with known effect (see section Special warnings and
precautions for use):
Phenylalanine
.......................................................................................................................................
10
micrograms
For the full list of excipients, see section List of excipients
VIVAXIM may contain traces of neomycin, which is used during the
manufacturing process (see section
Contraindications).
PHARMACEUTICAL FORM
Suspension for injection in a prefilled dual chamber syringe.
The inactivated hepatitis A vaccine is a cloudy and whitish
suspension; the typhoid polysaccharide vaccine
is a clear and colourless solution.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
VIVAXIM is indicated for combined active immunisation against typhoid
fever and infection with Hepatitis
A virus in subjects aged 16 years or more.
VIVAXIM must be administered according to official recommendations.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 1 m
l of mixed vaccine.
Initial protection is obtained after a single injection of VIVAXIM.
Protective antibody levels are
only obtained 14 days after administration