RabipurPowder and solvent for solution for injection in pre-filled syringe.Rabies vaccine (inactivated)

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Rabies virus (flury lep) inactivated

Tilgængelig fra:

GSK Vaccines GmbH

ATC-kode:

J07BG; J07BG01

INN (International Name):

Rabies virus (flury lep) inactivated

Dosering:

>= 2.5 international unit(s)/millilitre

Lægemiddelform:

Infus/Pdr/Oral Soln

Recept type:

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

Terapeutisk område:

Rabies vaccines; rabies, inactivated, whole virus

Autorisation status:

Not marketed

Autorisation dato:

2016-07-08

Indlægsseddel

492267
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RABIES VIRUS (INACTIVATED, STRAIN FLURY LEP)
PACKAGE LEAFLET: INFORMATION FOR THE USER
RABIPUR
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU/YOUR CHILD RECEIVES
RABIPUR. 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/your child 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 RABIPUR is and what it is used for
2.
What you need to know before you/your child receives RABIPUR
3.
How to use RABIPUR
4.
Possible side effects
5.
How to store RABIPUR
6.
Contents of the pack and other information
1 WHAT RABIPUR IS AND WHAT IT IS USED FOR
WHAT RABIPUR IS
Rabipur is a vaccine containing rabies virus that has been killed.
After administration of the vaccine, the immune system (the body's
natural defence system) forms antibodies to rabies viruses. These
antibodies protect from infections or diseases by the virus
that causes rabies. None of the components of the vaccine can cause
rabies.
WHAT RABIPUR IS USED FOR
Rabipur can be used in individuals of all ages.
Rabipur can be used to prevent rabies:
•
before possible risk of exposure to rabies virus (pre-exposure
prophylaxis).
or
•
after suspected or proven exposure to rabies virus (post-exposure
prophylaxis).
Rabies is an infection that can be transmitted when a person is
bitten, scratched or even just licked by an infected animal,
particularly when
the skin is already injured. Even contact with animal traps that were
licked or bitten by infected animals can cause infections in humans.
2. WHAT YOU NEED TO KNOW BEFORE YOU/YOUR CHILD RECEIVES RABIPUR
YOU/YOUR CHILD MUST NOT RECEIVE RABIPUR BEFORE POSSIBLE RISK OF
EXPOSURE TO THE RABIES VIRUS IF YOU/YOUR CHILD:
•
H

Produktets egenskaber

Health Products Regulatory Authority
02 December 2019
CRN0097SG
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
RabipurPowder and solvent for solution for injection in pre-filled
syringe.Rabies vaccine (inactivated)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 vial (1.0 ml) contains:
Rabies virus* (Inactivated, strain Flury
LEP)……………………… ≥ 2.5 IU
* produced on purified chick embryo cells (PCEC)
This vaccine contains residues of chicken proteins (e.g., ovalbumin),
human serum albumin, and may contain traces of
neomycin, chlortetracycline and amphotericin B. See section 4.4.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection in pre-filled syringe.
The powder is white.
The solvent is clear and colourless.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rabipur is indicated for active immunization against rabies in
individuals of all ages.
See Sections 4.2 and 5.1 for detailed information about pre- and
post-exposure prophylaxis.
Rabipur should be used in accordance with official recommendations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose for both primary immunization and boosters is 1.0
ml.
_Pre-exposure prophylaxis_
Primary immunization
In previously unvaccinated individuals, three doses should be
administered according to the conventional or rapid regimen, as
shown in Table 1.
Table 1 Primary immunization regimens
_Conventional regimen_
_Rapid Regimen*_
1
st
dose
Day 0
Day 0
2
nd
dose
Day 7
Day 3
3
rd
dose
Day 21 (or 28)
Day 7
*
The rapid regimen should only be considered for adults aged 18-65
years not able to complete the conventional pre-exposure
prophylaxis regimen within 21 or 28 days before protection is
required.
Booster doses
Booster doses are generally recommended every 2-5 years. Timing for
booster after vaccination with rapid regimen has not yet
been established (see also section 5.1). Serological testing for the
presence of antibody �