Havrix Monodose Vaccine

দেশ: মাল্টা

ভাষা: ইংরেজি

সূত্র: Medicines Authority

সক্রিয় উপাদান:

HEPATITIS A VIRUS (INACTIVATED)

থেকে পাওয়া:

Smithkline Beecham Limited

এটিসি কোড:

J07BC02

INN (আন্তর্জাতিক নাম):

HEPATITIS A VIRUS (INACTIVATED)

ফার্মাসিউটিকাল ফর্ম:

SUSPENSION FOR INJECTION

রচনা:

HEPATITIS A VIRUS (INACTIVATED) 1440 ELISA unit/dose

প্রেসক্রিপশন টাইপ:

POM

থেরাপিউটিক এলাকা:

VACCINES

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2006-11-22

তথ্য লিফলেট

Reason for Update: SB name change plc to Ltd 
MHRA Approval Date: 5 March 2014 
Text Date: 10 January 2014 
Text Issue and Draft No.: Issue 7, Draft 1 
SPC Issue and Draft No.: Issue 6, Draft 1 

- 1 - 
GLAXOSMITHKLINE (LOGO) 

PACKAGE LEAFLET: INFORMATION FOR THE USER 
HAVRIX® MONODOSE®  VACCINE  
Suspension for injection in a pre-filled syringe 
Hepatitis A (inactivated) vaccine (adsorbed) 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU RECEIVE 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, nurse or
pharmacist. 

  This vaccine has been prescribed for you. Do not
pass it on to others. It may harm them.  

  If you get any side effects talk to your doctor, nurse or
pharmacist.  This includes any 
possible side effects not listed in this leaflet. 
WHAT IS IN THIS LEAFLET: 
1  What Havrix Monodose is and what it is used for 
2  What you need to know before you receive Havrix Monodose 
3  How Havrix Monodose is given 
4  Possible side effects 
5  How to store Havrix Monodose 
6  Contents of the pack and other information 

1  
WHAT HAVRIX MONODOSE IS AND WHAT IT IS USED FOR  

Havrix Monodose is a vaccine containing hepatitis A virus. 
It is used to boost the body’s 
immune system to help
protect against hepatitis A  infection in adults and
adolescents (16 
years of age and above). 

HOW HAVRIX MONODOSE WORKS 

  The virus is not alive so this vaccine cannot cause
hepatitis A infection. 

  When you are given Havrix Monodose vaccine your body
will make antibodies (the 
body’s natural defence system) against the hepatitis A virus. 

  After 2 to 4 weeks, these antibodies will have been produced
and will protect you against 
hepati

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Havrix Monodose Vaccine
Suspension for injection in a pre-filled syringe
Hepatitis A (inactivated) vaccine (adsorbed)
Havrix Monodose Vaccine
Suspension for injection in a vial
Hepatitis A (inactivated) vaccine (adsorbed)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (1.0 ml) 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+
Havrix Monodose Vaccine may contain traces of neomycin B sulfate,
which is
used during the manufacturing process (see section 4.3).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Suspension for injection.
Turbid liquid suspension.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Active immunisation against infections caused by hepatitis A virus.
The
vaccine is particularly indicated for those at increased risk of
infection or
transmission. For example immunisation should be considered for the
following risk groups:
Travellers visiting areas of medium or high endemicity, i.e. anywhere
outside
northern or western Europe, Australia, North America and New Zealand.
Military and diplomatic personnel.
Persons for whom Hepatitis A is an occupational hazard or for whom
there is
an increased risk of transmission. These include employees in day care
centres, nursing, medical and paramedical personnel in hospitals and
institutions, especially gastroenterology and paediatric units, sewage
workers
and food packagers or handlers.
Haemophiliacs.
Intravenouse drug abusers.
Homosexual men.
Patients with chronic liver disease (including alcoholic cirrhosis,
chronic
hepatitis B, chronic hepatitis C, autoimmune hepatitis, primary
biliary
cirrhosis).
Since virus shedding from infected persons may occur for a prolonged
period,
active immunisation of close contacts may be considered.
In addition there may be other groups at risk or specific
circumstances such as
an outbreak of hepatitis A inf