Rabipur vaccine powder and solvent for solution for injection 1ml pre-filled syringes

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Rabies virus inactivated

Saatavilla:

Valneva UK Ltd

ATC-koodi:

J07BG01

INN (Kansainvälinen yleisnimi):

Rabies virus inactivated

Lääkemuoto:

Powder and solvent for solution for injection

Antoreitti:

Intramuscular

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 14040000; GTIN: 5000123114627

Pakkausseloste

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RABIPUR
Powder and solvent for solution for injection in pre-filled syringe
Rabies virus (Inactivated, strain Flury LEP)
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:
•
Have/h

Valmisteyhteenveto

OBJECT 1
RABIPUR PRE-FILLED SYRINGE
Summary of Product Characteristics Updated 07-Jun-2018 |
GlaxoSmithKline UK
1. Name of the medicinal product
Rabipur
Powder 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 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 with
rapid regimen has not yet been established (see also section 5.1).
Serological testing for the presence of
antibod