Havrix Monodose vaccine suspension for injection 1ml pre-filled syringes

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Hepatitis A virus inactivated

Dostupné s:

GlaxoSmithKline UK Ltd

ATC kód:

J07BC02

INN (Mezinárodní Name):

Hepatitis A virus inactivated

Léková forma:

Suspension for injection

Podání:

Intramuscular

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 14040000; GTIN: 5000483111090 5000483111106

Informace pro uživatele

- 1 -
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
hepatitis A infection.
•
To ensure long term protection, 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 of
hepatitis virus or any other illness that can cause hepatitis
(inflammation of the liver).

Charakteristika produktu

OBJECT 1
HAVRIX MONODOSE VACCINE
Summary of Product Characteristics Updated 09-Dec-2016 |
GlaxoSmithKline UK
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 ma