VAQTA Adult 50 U/1 ml, suspension for injection in a prefilled syringe. Hepatitis A vaccine, inactivated, adsorbed. For adults

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Strain cr 326f hepatitis a virus, inactivated 50 u

Available from:

Merck Sharp & Dohme Ireland (Human Health) Limited

ATC code:

J07BC; J07BC02

INN (International Name):

Strain cr 326f hepatitis a virus, inactivated 50 u

Dosage:

50 U/1 millilitre(s)

Pharmaceutical form:

Suspension for injection in pre-filled syringe

Prescription type:

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

Therapeutic area:

Hepatitis vaccines; hepatitis A, inactivated, whole virus

Authorization status:

Not marketed

Authorization date:

1996-12-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VAQTA® 50 U/1 ML SUSPENSION FOR INJECTION IN A PREFILLED SYRINGE
Hepatitis A vaccine, inactivated, adsorbed
For adults
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE VACCINATED 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, pharmacist or
nurse.
-
This vaccine has been prescribed for you only. Do not pass it on to
others.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What VAQTA 50 U/1 mL is and what it is used for
2.
What you need to know before VAQTA 50 U/1 mL is given
3.
How VAQTA 50 U/1 mL is given
4.
Possible side effects
5.
How to store VAQTA 50 U/1 mL
6.
Contents of the pack and other information
1.
WHAT VAQTA 50 U/1 ML IS AND WHAT IT IS USED FOR
VAQTA 50 U/1 mL is a vaccine. Vaccines are used to protect against
infectious diseases. They work
by causing the body to produce its own protection against the targeted
disease.
VAQTA50 U/1 mL helps to protect adults (18 years of age and older)
against disease caused by
hepatitis A virus.
Hepatitis A infection is caused by a virus that attacks the liver. It
may be caught from food or drink that
contains the virus. Symptoms include jaundice (yellowing of the skin
and eyes) and feeling generally
unwell.
When you are given an injection of VAQTA 50 U/1 mL, the body’s
natural defences will start to
produce protection (antibodies) against the hepatitis A virus.
However, it usually takes 2 to 4 weeks
after receiving the injection before you will be protected.
VAQTA 50 U/1 mL will not prevent hepatitis caused by infectious agents
other than hepatitis A virus.
Additionally, if you are already infected with hepatitis A virus when
you are given VAQTA 50 U/1 mL,
the vaccination may not prevent the illness.
VAQTA 50 U/1 mL protects against hepatitis A but cannot cause a
hepatitis A infecti

Summary of Product characteristics

Health Products Regulatory Authority
08 December 2022
CRN00D9GG
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
VAQTA Adult 50 U/1 ml, suspension for injection in a prefilled
syringe. Hepatitis A vaccine, inactivated, adsorbed. For adults
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (1mL) contains:
Hepatitis A virus (strain CR 326F) (inactivated)
1, 2
…………………50 U
3
1
Produced on human diploid (MRC–5) fibroblast cells.
2
Adsorbed on amorphous aluminium hydroxyphosphate sulphate ( 0.45 mg Al
3+
).
3
Units measured according to the in-house method of the
manufacturer-Merck Sharp & Dohme LLC
This vaccine may contain traces of neomycin and formaldehyde, which
are used during the manufacturing process. See
sections 4.3 and 4.4.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection in a prefilled syringe.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
VAQTA 50 U/1 mL is indicated for active pre-exposure prophylaxis
against disease caused by hepatitis A virus. VAQTA
50 U/1 mL is recommended for healthy adults 18 years of age and older
who are at risk of contracting or spreading infection or
who are at risk of life-threatening disease if infected (e.g., those
with Human Immunodeficiency Virus [HIV] or hepatitis C with
diagnosed liver disease).
The use of VAQTA should be based on official recommendations.
For optimal antibody response, primary immunization should be given at
least 2, preferably 4 weeks prior to expected
exposure to hepatitis A virus.
VAQTA will not prevent hepatitis caused by infectious agents other
than hepatitis A virus.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The vaccination series consists of one primary dose and one booster
dose given according to the following schedule:
Health Products Regulatory Authority
08 December 2022
CRN00D9GG
Page 2 of 9
_Primary dose:_
Adults 18 years of age and older should receive a single 1.0 mL (50 U)
dose of vaccine at an elected date.
_Booster dose:_
Adults 18