VAQTA Paediatric vaccine suspension for injection 0.5ml vials

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Hepatitis A virus inactivated

Saadav alates:

Organon Pharma (UK) Ltd

ATC kood:

J07BC02

INN (Rahvusvaheline Nimetus):

Hepatitis A virus inactivated

Ravimvorm:

Suspension for injection

Manustamisviis:

Intramuscular

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 14040000; GTIN: 5015973393016

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER
VAQTA
® PAEDIATRIC, SUSPENSION FOR INJECTION
Hepatitis A vaccine, inactivated, adsorbed
For children and adolescents
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD IS
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 or your child only. Do not
pass it on to
others.
•
If you or your child gets 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 Paediatric is and what it is used for
2.
What you need to know before Vaqta Paediatric is given
3.
How Vaqta Paediatric is given
4.
Possible side effects
5.
How to store Vaqta Paediatric
6.
Contents of the pack and other information
Vaqta Paediatric is one of a general group of medicines called
vaccines. Vaccines are
used to protect against infectious diseases. They work by causing the
body to produce its
own protection against the targeted disease.
This vaccine helps to protect against hepatitis A infection.
Hepatitis A is a virus that attacks the liver, which can be caught
from food or drink that
contains the virus. Symptoms of hepatitis A include a yellowing of the
skin and eyes
(jaundice) and feeling generally unwell.
When an injection of this vaccine is given, the body’s natural
defences will produce
protection (antibodies) against the hepatitis A infection. However, it
usually takes 2 to 4
weeks after receiving the injection before you or your child will be
protected.
This vaccine will not protect against other viruses that infect the
liver (such as hepatitis
B, hepatitis C or hepatitis E). This vaccine protects against
hepatitis A but cannot cause a
hepatitis A infection.
The vaccination may not work properly if the person to be vaccinated
is already infected
with the hepatitis A virus.
Vaqta Pae

Toote omadused

OBJECT 1
VAQTA PAEDIATRIC
Summary of Product Characteristics Updated 03-Feb-2017 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
VAQTA® PAEDIATRIC, SUSPENSION FOR INJECTION
Hepatitis A Vaccine, inactivated, adsorbed.
For children and adolescents.
2. Qualitative and quantitative composition
One dose (0.5mL) contains:
Hepatitis A virus (strain CR 326F) (inactivated)
1,2
…………………25 U
3
1
Produced on human diploid (MRC–5) fibroblast cells.
2
Adsorbed on amorphous aluminium hydroxyphosphate sulphate (0.225 mg Al
3+
).
3
Units measured according to the in-house method of the
manufacturer-Merck Sharp & Dohme Corp.
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 or vial.
4. Clinical particulars
4.1 Therapeutic indications
VAQTA Paediatric is indicated for active pre-exposure prophylaxis
against disease caused by hepatitis A
virus. VAQTA Paediatric is recommended for healthy individuals from 12
months of age to 17 years of
age who are at risk of contracting or spreading infection or who are
at risk of life-threatening disease if
infected (e.g., hepatitis C with diagnosed liver disease).
The use of VAQTA Paediatric should be based on official
recommendations.
For optimal antibody response, primary immunisation should be given at
least 2, preferably 4, weeks
prior to expected exposure to hepatitis A virus.
VAQTA Paediatric 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:
_Primary dose:_
Children and adolescents aged 12 months to 17 years of age should
receive a single 0.5 mL (25U) dose of
vaccine at an elected date.
Safety and effectiveness in infants <12 months of age have not been
est