Hepatyrix

देश: न्यूज़ीलैंड

भाषा: अंग्रेज़ी

स्रोत: Medsafe (Medicines Safety Authority)

सक्रिय संघटक:

Hepatitis A vaccine 1440 EU/mL (virus antigen (HM175 strain)); Vi capsular polysaccharide of S. typhi ty2 25 µg/mL;  

थमां उपलब्ध:

GlaxoSmithKline NZ Limited

INN (इंटरनेशनल नाम):

Hepatitis A vaccine 1440 EU/mL (virus antigen (HM175 strain))

फार्मास्यूटिकल फॉर्म:

Suspension for injection

रचना:

Active: Hepatitis A vaccine 1440 EU/mL (virus antigen (HM175 strain)) Vi capsular polysaccharide of S. typhi ty2 25 µg/mL   Excipient: Aluminium hydroxide Amino acids Formaldehyde Neomycin sulfate Polysorbate 20 Sodium chloride Trometamol Water for injection

पैकेज में यूनिट:

Syringe, glass, pre-filled, 1 mL

वर्ग:

Prescription

प्रिस्क्रिप्शन प्रकार:

Prescription

द्वारा बनाया गया:

GlaxoSmithKline Biologicals SA

चिकित्सीय संकेत:

HEPATYRIX is indicated for active immunisation of adults and adolescents older than 15 years of age at risk of both hepatitis A virus infection and typhoid fever. Immunisation with HEPATYRIX is particularly recommended in subjects who are, or will be, at increased risk of infection such as travellers from countries of low endemicity to areas where the prevalence of hepatitis A and typhoid fever is high.

उत्पाद समीक्षा:

Package - Contents - Shelf Life: Syringe, glass, pre-filled - 1 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, glass, pre-filled, 1mL - 10 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, - 3 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, 3mL pack - 10 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

प्राधिकरण की तारीख:

2002-02-21

सूचना पत्रक

1
HEPATYRIX
®
(COMBINED INACTIVATED HEPATITIS A AND VI POLYSACCHARIDE TYPHOID
VACCINE)
CONSUMER MEDICINE INFORMATION LEAFLET
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions about HEPATYRIX
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 HEPATYRIX against the expected
benefits.
IF YOU HAVE ANY CONCERNS ABOUT RECEIVING HEPATYRIX TALK TO YOUR
DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET WITH THIS VACCINE. You may need to read it again.
WHAT HEPATYRIX IS USED FOR
HEPATYRIX is a combination vaccine used to prevent hepatitis A and
typhoid fever. The
vaccine works by causing the body to produce its own protection
(antibodies) against
these diseases.
Hepatitis A is an infectious disease caused by a virus, which causes
the liver to be
become inflamed (swollen). Typhoid fever is an infectious disease
caused by a bacteria
called _Salmonella typhi._
_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 beome 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.
_Typhoid Fever _
Symptoms of typhoid fever can begin at varying times after coming into
contact with
the bacteria. These consist of headache, pains in the stomach,
constipation or
diarrhoea and a fever that may last for one or two weeks. Patients
normally get better
after about four weeks, but relapses can occur.
The hepatitis A virus and _Salmonella typhi _bacteria can both be
passed from person to
person in food and drink, or by swimming in water contaminated by
sewage. These
diseases are very

उत्पाद विशेषताएं

1
DATA SHEET
NAME OF MEDICINAL PRODUCT
HEPATYRIX
_Inactivated hepatitis A and purified Vi polysaccharide typhoid
vaccine _
PRESENTATION
HEPATYRIX

is a combined vaccine formulated by pooling bulk preparations of the
purified, inactivated hepatitis A virus (HM175 hepatitis A virus
strain) adsorbed onto
aluminium hydroxide and the Vi capsular polysaccharide extracted from
_ Salmonella _
_typhi_ Ty2 strain.
HEPATYRIX

meets the WHO requirements for manufacture of biological substances
and complies with the European Pharmacopoeia monograph for Vi
polysaccharide
typhoid vaccines and the European Pharmacopoeia monograph for
Hepatitis A vaccine
(inactivated, adsorbed).
Each 1 ml dose of vaccine contains 25 µg of the Vi polysaccharide of
_Salmonella typhi_
and not less than 1440 ELISA Units (EL.U.) of inactivated hepatitis A
viral antigen.
_THERAPEUTIC INDICATIONS _
HEPATYRIX

is indicated for active immunisation of adults and adolescents older
than
15 years of age at risk of both hepatitis A virus infection and
typhoid fever.
Immunisation with HEPATYRIX

is particularly recommended in subjects who are, or
will be, at increased risk of infection such as travellers from
countries of low endemicity
to
areas
where
the
prevalence
of
hepatitis
A
and
typhoid
fever
is
high.
_POSOLOGY AND METHOD OF ADMINISTRATION _
The vaccine is a ready-to-use suspension. It must be shaken well
before use, since upon
storage, the vaccine settles down as a fine white deposit with a clear
colourless
supernatant. After shaking the vaccine is a slightly opaque, white
suspension. Discard if
the contents appear otherwise. All parenteral compounds and vaccine
products should be
inspected visually prior to administration for discolouration or
particulate matter.
DOSAGE
A dose of 1.0 ml is recommended for adults and adolescents older than
15 years of age.
A single dose of HEPATYRIX

is used for primary immunisation. For travellers, this
dose should be given at least 2 weeks prior to departure.
2
_BOOSTER DOSE _
The anti-HAV and anti-Vi a