Twinrix Junior

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Hepatitis A vaccine 720 EU/mL;  ; Hepatitis B surface antigen, recombinant 20 µg/mL; Hepatitis A vaccine 720 EU/mL; Hepatitis B surface antigen, recombinant 20 µg/mL

Available from:

GlaxoSmithKline NZ Limited

INN (International Name):

Hepatitis A vaccine 720 EU/mL

Pharmaceutical form:

Suspension for injection

Composition:

Active: Hepatitis A vaccine 720 EU/mL   Hepatitis B surface antigen, recombinant 20 µg/mL Excipient: Aluminium Amino acids Formaldehyde Neomycin sulfate Phenoxyethanol Polysorbate 20 Sodium chloride Water for injection Active: Hepatitis A vaccine 720 EU/mL Hepatitis B surface antigen, recombinant 20 µg/mL Excipient: Aluminium Amino acids Dibasic sodium phosphate monohydrate Formaldehyde Monobasic sodium phosphate dihydrate Neomycin sulfate Polysorbate 20 Sodium chloride Trometamol Water for injection

Units in package:

Syringe, 0.5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

GlaxoSmithKline Biologicals SA

Therapeutic indications:

TWINRIX JUNIOR is indicated for active immunisation against hepatitis A and hepatitis B virus infection in infants, children and adolescents from 1 year up to and including 15 years of age at risk of, or who wish to be protected against, both infections.

Product summary:

Package - Contents - Shelf Life: Syringe, - 0.5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

1996-10-14

Patient Information leaflet

1
TWINRIX
® ADULT AND TWINRIX
® JUNIOR
Inactivated hepatitis A and recombinant DNA hepatitis B vaccine
CONSUMER MEDICINE INFORMATION
In this leaflet, TWINRIX refers to both TWINRIX ADULT and TWINRIX
JUNIOR.
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions about TWINRIX
vaccine. It does not contain all the
available information. It does not take the place of talking to your
doctor or pharmacist.
All medicines and vaccines have risks and benefits. Your doctor has
weighed the possible risks of you or
your child having TWINRIX against the expected benefits.
IF YOU HAVE ANY CONCERNS ABOUT RECEIVING TWINRIX TALK TO YOUR DOCTOR,
NURSE OR PHARMACIST.
WHAT TWINRIX IS USED FOR
TWINRIX is a combination vaccine used to prevent hepatitis A and
hepatitis B infection. The vaccine
works by causing the body to produce its own protection (antibodies)
against these diseases.
Hepatitis A and hepatitis B are infectious diseases, which cause the
liver to be become inflamed (swollen).
These diseases are caused by viruses - hepatitis A and hepatitis B
viruses.
Hepatitis A
Symptoms of hepatitis A usually begin 3 to 6 weeks after coming into
contact with the virus. These consist
of nausea (feeling sick), fever, aches and pains. After a few days the
skin and/or the whites of the eyes may
become yellowish (jaundice). The severity and type of symptoms can
vary. Hepatitis A is often milder in
young children. Most people recover completely but the illness is
usually severe enough to keep adults off
work for about a month.
The hepatitis A virus can be passed from person to person in food and
drink, or by swimming in water
contaminated by sewage. Hepatitis A is very common in many parts of
the world and the risk of infection is
greatest in those areas where hygiene and sanitation are poor. Areas
include Asia, India, Africa, Central and
South America, the Pacific Islands, the Middle East, and the
Mediterranean Basin. Vaccination is
recommended for travellers to these areas, including people in the
armed forces.
Some gro

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
TWINRIX: inactivated hepatitis A vaccine 720 EU/mL and recombinant DNA
hepatitis B
surface antigen, 20 µg/mL, suspension for injection
TWINRIX JUNIOR: inactivated hepatitis A vaccine 720 EU/mL and
recombinant DNA
hepatitis B surface antigen, 20 µg/mL, suspension for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
TWINRIX and TWINRIX JUNIOR are combined vaccines formulated by pooling
bulk
preparations of the purified, inactivated hepatitis A (HA) virus and
purified hepatitis B
surface antigen (HBsAg), separately adsorbed onto aluminium hydroxide
and aluminium
phosphate. The HA virus is propagated in MRC5 human diploid cells.
HBsAg is produced
by culture, in a selective medium, of genetically engineered yeast
cells.
A 1.0 mL dose of TWINRIX contains not less than 720 ELISA units of
inactivated HA virus,
and 20

g of recombinant HBsAg protein.
A 0.5 mL dose of TWINRIX JUNIOR contains not less than 360 ELISA units
of inactivated
HA virus, and 10

g of recombinant HBsAg protein.
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Suspension for injection.
When re-suspended, the vaccine will have a uniform hazy white
appearance. Upon
storage, a fine white deposit with a clear colourless layer above may
be observed.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TWINRIX is indicated for active immunisation against hepatitis A and
hepatitis B virus
infection in adults.
TWINRIX is indicated in, but not limited to, the following groups of
susceptible subjects at
risk of acquiring hepatitis A and hepatitis B virus infection:
•
Healthcare personnel
•
Patients frequently receiving blood products
•
Personnel and residents of institutions
•
Persons at increased risk due to their sexual behaviour
2
•
Illicit users of addictive injectable drugs
•
Travellers to areas of high HAV and HBV endemicity
•
Persons originating from areas of high HAV and HBV endemicity
•
Organ transplant candidates
•
Armed forces personnel