Havrix Monodose Vaccine. Hepatitis A Vaccine (inactivated, adsorbed), 1440 ELISA units/ 1ml Suspension for injection in a pre-filled syringe

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Aluminium; Hepatitis A antigen

Beszerezhető a:

GlaxoSmithKline (Ireland) Limited

ATC-kód:

J07BC; J07BC02

INN (nemzetközi neve):

Aluminium; Hepatitis A antigen

Adagolás:

1440 enzyme-linked immunosorbent assay unit

Gyógyszerészeti forma:

Suspension for injection in pre-filled syringe

Recept típusa:

Product subject to prescription which may not be renewed (A)

Terápiás terület:

Hepatitis vaccines; hepatitis A, inactivated, whole virus

Engedélyezési státusz:

Not marketed

Engedély dátuma:

1994-12-13

Betegtájékoztató

- 1 -
GSK (LOGO)
PACKAGE LEAFLET: INFORMATION FOR THE
USER
HAVRIX MONODOSE
VACCINE
Hepatitis A Vaccine (Inactivated, adsorbed). 1440 ELISA Units/1 ml
Suspension for Injection in a pre-filled syringe
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, nurse or
pharmacist.
•
This vaccine has been prescribed for you only. Do not pass it on to
others. It may harm
them.
•
If you get any side-effects, talk to your doctor or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
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 inactivated hepatitis A virus.
It is used to boost the
body’s immune system to stop infection from hepatitis A 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
hepatitis A infection.
•
To ensure long term protection from hepatitis A of up to 40 years, you
should receive a
second (booster) vaccination 6 to 12 months after your first dose. As
long as you receive
the booster within 5 years, you should still be fully protected. Once
you have had your
booster vaccination, you are not expected to need an additional dose
of Havrix.
•
Having this vaccine will only protect against hepatitis A and not
against any other type

Termékjellemzők

Health Products Regulatory Authority
11 May 2023
CRN00DKK3
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Havrix Monodose Vaccine. Hepatitis A Vaccine (inactivated, adsorbed),
1440 ELISA units/ 1ml Suspension for injection in a
pre-filled syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance:
​
1 dose (1ml) contains:
​
​
Hepatitis A virus (HM175strain) (inactivated)
1,2
​
1440 ELISA units/1 ml
1
Adsorbed on aluminium hydroxide, hydrated (Total: 0.5 mg Al
3+
)
2
Produced on MRC-5 human diploid cells
Excipient(s) with known effect:
This vaccine contains phenylalanine 166 micrograms per dose (see
section 4.4).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suspension for injection in a pre-filled syringe.
Slightly opaque white suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Active immunisation with hepatitis A vaccine is recommended for
non-immune adult and adolescent (16 years of age and
above) travellers to high risk areas, (Africa, Asia, Central and South
America, the Middle East, possibly Southern and Eastern
Europe).
Other high risk non-immune groups may be considered for immunisation.
- Those with recent close contact with infected individual
- Child care workers
- Staff and residents at institutions for persons with mental handicap
- Persons with haemophilia and recipients of plasma-derived clotting
factors
- Patients with chronic liver disease especially if visiting a high
risk area
- Health care workers
- Food handlers
- Sewage workers
- Prison officers
- Those with renal failure prior to dialysis
- Military and diplomatic personnel
- Intravenous drug abusers
- Homosexuals
- Persons with multiple sexual partners
It is also indicated for use during outbreaks of hepatitis A
infection.
If there is a history of jaundice, age over 50 years or residence in
high risk areas, then screening for immunity to hepatitis A is
advised before immunisation.
If the blood test confirms immuity to hepatitis A, immunisation is not
neede