VIVAXIM 1mL injection syringe composite pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Hepatitis a virus antigen, Quantity: 160 ELISA unit

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: neomycin; formaldehyde; bovine serum albumin; polysorbate 80; aluminium hydroxide hydrate; phenoxyethanol; glucose monohydrate; ascorbic acid; sodium chloride; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; monobasic potassium phosphate; dibasic sodium phosphate; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; isoleucine; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; Biotin; ergocalciferol; calcium pantothenate; choline chloride; folic acid; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium

Administration route:

Intramuscular

Units in package:

1 x single dose pre-filled dual-chamber syringe

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

VIVAXIM is indicated for simultaneous active immunisation against typhoid fever and hepatitis A virus infections in subject's aged 16 and older.

Product summary:

Visual Identification: CLOUDY, WHITISH SUSPENSION.; Container Type: Syringe; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2002-09-24

Patient Information leaflet

VIVAXIM
®
_Salmonella typhi Vi polysaccharide and inactivated hepatitis A virus
antigen vaccine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Vivaxim.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines, including vaccines,
have risks and benefits. Your doctor
has weighed the risks of you having
Vivaxim against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
VACCINE, ASK YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET. YOU MAY NEED TO
READ IT AGAIN.
WHAT VIVAXIM IS USED
FOR
Vivaxim is a vaccine used to help
prevent typhoid fever and hepatitis A
disease in adults aged 16 years and
older who are at risk of these
diseases.
_HOW IT WORKS_
Vivaxim works by causing your body
to produce its own protection against
typhoid fever and hepatitis A
infection. It does this by making
substances called antibodies in the
blood, which fight the typhoid
bacteria and hepatitis A virus. If a
vaccinated person comes into contact
with the typhoid or hepatitis A
organisms, the body is usually ready
to destroy them.
Your body usually takes two weeks
after vaccination to develop
protection against typhoid fever and
hepatitis A infection.
Initial protection is provided by one
dose of Vivaxim. For long-lasting
protection against hepatitis A virus a
booster vaccination with a hepatitis
A vaccine will be required 6 to 36
months after vaccination with
Vivaxim. The body does not develop
long-term protection against typhoid
fever and repeat vaccinations are
required to maintain protection.
Most people will produce enough
antibodies against typhoid fever and
hepatitis A infection. However, as
with all vaccines, 100% protection
cannot be guaranteed.
The vaccine will not give you
typhoid fever or hepatitis A infection.
The chance of a severe reaction from
Vivaxim is very small, but the risks
from not being vaccinated against
typhoid fever or hepatitis A infection
may be ve

Summary of Product characteristics

viv-ccdsv09-piv4-05mar20
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION – VIVAXIM (_SALMONELLA _
_TYPHI_ VI POLYSACCHARIDE & HEPATITIS A VIRUS ANTIGEN)
VACCINE
1
NAME OF THE MEDICINE
_Salmonella typhi_
Vi polysaccharide and hepatitis A virus antigen.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vivaxim contains a sterile suspension of purified
_Salmonella typhi _
Vi polysaccharide and
formaldehyde-inactivated hepatitis A virus (HAV) antigen (GBM strain)
adsorbed onto
aluminium hydroxide. Vivaxim is presented in a dual-chamber by-pass
syringe. The contents
of both chambers are mixed immediately prior to injection by slowly
pressing the plunger.
Each 1.0 mL dose of mixed vaccine contains:
ACTIVE INGREDIENTS:
_Salmonella typhi_
Vi polysaccharide (Ty 2 strain)
25 micrograms
Hepatitis A virus antigen*
160 antigen units**
*
GBM strain cultured on MRC-5 human diploid cells. MRC-5 is a cell line
that was
derived from human embryonic lung tissue in the 1960s.
**
In the absence of an international standardised reference, the antigen
content is
expressed using an in-house reference.
Excipients with known effects: phenylalanine and residual neomycin.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
The typhoid polysaccharide component is a clear and colourless
solution, the hepatitis A
component (inactivated, adsorbed) is a cloudy whitish suspension.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vivaxim is indicated for simultaneous active immunisation against
typhoid fever and
hepatitis A virus infections in subjects aged 16 and older.
viv-ccdsv09-piv4-05mar20
Page 2 of 14
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dosage is 1 mL of the mixed vaccine.
Vivaxim should be administered by slow intramuscular injection in the
deltoid region.
Vivaxim must not be administered intradermally or intravenously.
Primary immunisation is achieved with a single dose of Vivaxim.
The vaccine should be administered at least 14 days prior to risk of
exposure to both typhoid
fever and hepat