Hepatyrix vaccine suspension for injection 1ml pre-filled syringes

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Hepatitis A virus (HM175 strain) inactivated; Salmonella typhi (Ty2 strain) Vi capsular polysaccharide

可用日期:

GlaxoSmithKline UK Ltd

ATC代码:

J07BC20

INN（国际名称）:

Hepatitis A virus (HM175 strain) inactivated; Salmonella typhi (Ty2 strain) Vi capsular polysaccharide

药物剂型:

Suspension for injection

给药途径:

Intramuscular; Subcutaneous

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 14040000; GTIN: 5000483258702 5000483258801

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
HEPATYRIX

suspension for injection
Hepatitis A (inactivated) and Typhoid Polysaccharide vaccine
(adsorbed).
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING THIS
VACCINE BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This vaccine has been prescribed for you. Do not pass it on to others.
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section
4
IN THIS LEAFLET:
1.
What Hepatyrix is and what it is used for
2.
What you need to know before you receive Hepatyrix
3.
How Hepatyrix is given
4.
Possible side effects
5.
How to store Hepatyrix
6.
Contents of the pack and other information
1
WHAT HEPATYRIX IS AND WHAT IT IS USED FOR
Hepatyrix is a vaccine which helps prevent hepatitis A and typhoid
fever. Hepatitis A
is an infectious illness of the liver caused by a virus. Typhoid fever
is an infectious
illness caused by a type of bacteria called _Salmonella typhi. _
This vaccine should only be given to adults and teenagers aged 15
years and above.
HOW HEPATYRIX WORKS
Hepatyrix contains inactive hepatitis A virus and a very small part of
the bacterium
which cause typhoid fever.

The hepatitis A virus is not alive, so this vaccine cannot cause
hepatitis A
infection.

There are no live bacteria in this vaccine, so it cannot cause typhoid
fever.

When you are given the vaccine it will trigger the body’s immune
system to
prepare itself to protect against these viruses in the future.

Like other vaccines, Hepatyrix may not be totally effective in
protecting you
against hepatitis A and typhoid fever.

Hepatyrix will not protect you if you have already caught hepatitis A
or typhoid
fever.

Hepatyrix will only prevent diseases caused by Hepatitis A virus and
by the
bacterium _Salmonella typhi. _
Hepatitis A virus causes an infection of the

产品特点

OBJECT 1
HEPATYRIX
Summary of Product Characteristics Updated 16-Mar-2015 |
GlaxoSmithKline UK
1. Name of the medicinal product
Hepatyrix, suspension for injection
Hepatitis A (inactivated) and Typhoid Polysaccharide vaccine
(adsorbed).
2. Qualitative and quantitative composition
1 dose (1 ml) contains:
Hepatitis A virus (HM175 strain) (inactivated)
1
Vi polysaccharide of _Salmonella typhi_ (Ty2 strain)
1
Produced in human diploid (MRC-5) cells
Adsorbed on aluminium hydroxide, hydrated
1440 ELISA Units
25 micrograms
0.5 milligrams Al
3+
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Suspension for injection.
Hepatyrix is a slightly opaque white suspension.
4. Clinical particulars
4.1 Therapeutic indications
Hepatyrix is indicated for active immunisation against hepatitis A
virus infection and typhoid fever in
adults and adolescents 15 years of age and older.
Hepatyrix should be given in accordance with official recommendations.
4.2 Posology and method of administration
_Posology_
Primary vaccination
A single dose of 1.0 ml is recommended for both adults and adolescents
aged 15 years and older.
The vaccine should be given at least two weeks prior to risk of
exposure to typhoid and hepatitis A (see
section 5.1 for immunogenicity data).
Booster vaccination
In order to provide long term protection against infection caused by
hepatitis A virus, a booster dose of an
inactivated hepatitis A vaccine is recommended at any time between 6
and 12 months after a single dose
of Hepatyrix.
Hepatyrix may also be given as a single dose of 1.0 ml for booster
vaccination between 6 and 12 months
following primary immunisation with an inactivated hepatitis A vaccine
to subjects who also require
protection against typhoid fever.
Subjects who remain at risk of typhoid fever should be revaccinated
using a single dose of Vi
polysaccharide vaccine every 3 years (see section 5.1). Hepatyrix may
be used to revaccinate against
typhoid fever in subjects that also need to have a dose of hepatitis A
vaccine.
_Paediatri