Havrix Junior

Country: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Hepatitis A vaccine 1440 EU/mL equivalent to 720 EU/0.5 mL;  ; Hepatitis A vaccine 1440 EU/mL equivalent to 720 EU/0.5mL

Disponibbli minn:

GlaxoSmithKline NZ Limited

INN (Isem Internazzjonali):

Hepatitis A vaccine 1440 EU/mL (= 720 EU/0.5 mL)

Dożaġġ:

720 ELISA U/0.5mL

Għamla farmaċewtika:

Suspension for injection

Kompożizzjoni:

Active: Hepatitis A vaccine 1440 EU/mL equivalent to 720 EU/0.5 mL   Excipient: Aluminium hydroxide Amino acids Dibasic sodium phosphate dihydrate Monobasic potassium phosphate Polysorbate 20 Potassium chloride Sodium chloride Active: Hepatitis A vaccine 1440 EU/mL equivalent to 720 EU/0.5mL Excipient: Aluminium hydroxide Amino acids Dibasic sodium phosphate dihydrate Monobasic potassium phosphate Phenoxyethanol Polysorbate 20 Potassium chloride Sodium chloride

Unitajiet fil-pakkett:

Syringe, glass, prefilled syringe, 0.5 mL

Klassi:

Prescription

Tip ta 'preskrizzjoni:

Prescription

Manifatturat minn:

GlaxoSmithKline Biologicals SA

Indikazzjonijiet terapewtiċi:

HAVRIX is indicated for active immunisation against HAV infection in subjects at risk of exposure to HAV. HAVRIX will not prevent hepatitis infection caused by other agents such as hepatitis B virus, hepatitis C virus, hepatitis E virus or other pathogens known to infect the liver. In areas of low and intermediate prevalence of hepatitis A, immunisation with HAVRIX is particularly recommended in subjects who are, or will be, at increased risk of infection.

Sommarju tal-prodott:

Package - Contents - Shelf Life: Syringe, glass, prefilled syringe - 0.5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 3 days not refrigerated stored at or below 25°C - Vial, glass, Monodose, Type 1 glass. - 0.5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 3 days not refrigerated stored at or below 25°C

Data ta 'l-awtorizzazzjoni:

1995-11-27

Fuljett ta 'informazzjoni

1
HAVRIX
®
1440 AND HAVRIX
®
JUNIOR
Inactivated Hepatitis A Virus Vaccine
CONSUMER MEDICINE INFORMATION LEAFLET_ _
In this leaflet, HAVRIX refers to the use of both HAVRIX 1440 for
adults and HAVRIX Junior for children.
WHAT IS IN THIS LEAFLET?
This leaflet answers some of the common questions about HAVRIX
vaccine. It does not contain all the available
information. It does not take the place of talking to your doctor,
nurse or pharmacist.
All medicines and vaccines have risks and benefits. Your doctor has
weighed the possible risks of you or your child
having HAVRIX against the expected benefits.
IF YOU HAVE ANY CONCERNS ABOUT HAVRIX TALK TO YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET WITH THIS VACCINE
. You may need to read it again.
WHAT IS HAVRIX USED FOR
HAVRIX is a vaccine used to prevent hepatitis A infection. The vaccine
works by causing the body to produce its own
protection (antibodies) against this disease.
Hepatitis A is an infectious disease, which can affect the liver. This
disease is caused by the hepatitis A virus.
The hepatitis A virus can be passed from person to person in food and
drink, or by swimming in water contaminated by
sewage. Symptoms of hepatitis A begin 3 to 6 weeks after coming into
contact with the virus. These consist of nausea
(feeling sick), fever and aches and pains. After a few days the whites
of eyes and skin may become yellowish
(jaundice). The severity and type of symptoms can vary. Young children
may not develop jaundice. Most people
recover completely but the illness is usually severe enough to keep
people off work for about a month.
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. Such areas include Asia, India,
Africa, Central and South America, the Pacific Islands,
the Middle East, and the Mediterranean basin. HAVRIX is recommended
for all travellers to these areas, including
people in the armed forces.
Hepatitis A occurs in New Zealand, but is not common. Some gr

Karatteristiċi tal-prodott

1
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
HAVRIX 1440: 1440 EU/mL inactivated hepatitis A virus (HM 175
hepatitis A virus strain)
vaccine, suspension for injection.
HAVRIX JUNIOR: 720 EU/0.5 mL inactivated hepatitis A virus (HM 175
hepatitis A virus
strain) vaccine, suspension for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (1.0 mL) of HAVRIX 1440 contains:
Hepatitis A virus (inactivated)
1,2
1440 ELISA Units
1
Produced on human diploid (MRC-5) cells
2
Adsorbed on aluminium hydroxide, hydrated
Total: 0.50 milligrams Al
3+
One dose (0.5 mL) of HAVRIX JUNIOR contains:
Hepatitis A virus (inactivated)
1,2
720 ELISA Units
1
Produced on human diploid (MRC-5) cells
2
Adsorbed on aluminium hydroxide, hydrated
Total: 0.25 milligrams Al
3+
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Suspension for injection.
Turbid liquid suspension. Upon storage, a fine white deposit with a
clear colourless
supernatant can be observed.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HAVRIX is indicated for active immunisation against HAV infection in
subjects at risk of
exposure to HAV.
HAVRIX will not prevent hepatitis infection caused by other agents
such as hepatitis B
virus, hepatitis C virus, hepatitis E virus or other pathogens known
to infect the liver.
In areas of low and intermediate prevalence of hepatitis A,
immunisation with HAVRIX is
particularly recommended in subjects who are, or will be, at increased
risk of infection,
such as:
2
TRAVELLERS:
Persons travelling to areas where the prevalence of hepatitis A is
high. These areas include
Africa, Asia, the Mediterranean basin, the Middle East, Central and
South America.
ARMED FORCES:
Armed forces personnel who travel to higher endemicity areas or to
areas where hygiene is
poor, have an increased risk of HAV infection. Active immunisation is
indicated for these
individuals.
PERSONS FOR WHOM HEPATITIS A IS AN OCCUPATIONAL HAZARD OR FOR WHOM
THERE IS AN
INCREASED RISK OF TRANSMISSION:
These include employees in