Rabipur

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Rabies vaccine 2.5 [iU]

Available from:

Seqirus (NZ) Ltd

INN (International Name):

Rabies vaccine 2.5 IU

Dosage:

2.5 IU

Pharmaceutical form:

Injection with diluent

Composition:

Active: Rabies vaccine 2.5 [iU] Excipient: Disodium edetate Potassium L-glutamate Polygeline Sodium chloride Sucrose Trometamol Water for injection

Prescription type:

Prescription

Manufactured by:

GSK Vaccines GmbH

Therapeutic indications:

Active immunisation against rabies virus, including (a) pre-exposure immunisation, (b) post-exposure treatment following exposure to rabies virus

Product summary:

Package - Contents - Shelf Life: Combination pack, 1 vial vaccine + 1 diluent (syringe) - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, glass, Diluent - 1 mL - 60 months from date of manufacture stored stored between 2 to 30 deg C - Vial, glass, Vaccine component - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2014-01-13

Patient Information leaflet

1
RABIPUR
_(Rab-ee-per)_
Inactivated Rabies Virus Vaccine
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about RABIPUR
(Inactivated Rabies Virus Vaccine).
It does not contain all the available
information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines, including vaccines,
have risks and benefits. Your
doctor has weighed the risks of you
or your child having RABIPUR
against the benefits they expect it
will have.
IF YOU HAVE ANY CONCERNS ABOUT
THIS VACCINE, ASK YOUR DOCTOR,
NURSE OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT RABIPUR IS USED
FOR
RABIPUR is a vaccine used to help
prevent rabies infection in people
who either:
•
have been; or
•
are at risk of being
bitten, licked or
scratched by an animal
infected with rabies
virus.
Rabies is a very serious infection.
The rabies virus attacks the nerves
and the brain. Rabies infection can
be fatal if not treated as early as
possible.
_HOW IT WORKS_
RABIPUR works by encouraging
your body to protect itself against
rabies. The body makes
substances called antibodies that
fight the rabies virus.
If the rabies virus gets into
someone who has been
vaccinated against rabies, the
antibodies kill the virus before it
can cause damage.
After vaccination your body
takes several weeks to develop
enough antibodies to
successfully fight rabies_._
For vaccination against rabies
you need a course of 3 to 5
injections.
After this course, most people
produce enough antibodies
against rabies_. _ However, as
with all vaccines, RABIPUR may
not fully protect all people who are
vaccinated.
For people at risk, further
booster injections of rabies
vaccine may be needed every
few years to ensure enough
antibodies are present.
The vaccine will not give you or
your child rabies.
The chance of a severe
reaction from RABIPUR is very
small,
but the
risks from not
being vaccinated against rabies
may be very serious.
BEFORE YOU ARE GIVEN
RABIPUR
_WHEN YOU OR YOUR CHILD _
_MUST NOT BE GIVEN

Summary of Product characteristics

NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
RABIPUR
Inactivated Rabies Virus Vaccine
Powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
RABIPUR
is an inactivated rabies virus vaccine, derived from the fixed-virus
strain,
Flury LEP. The virus is propagated in a Purified Chick Embryo Cell
(PCEC) culture,
inactivated using β-propiolactone and purified via centrifugation. It
is supplied in a
single-dose presentation consisting of a vial containing lyophilised
powder (vaccine
component), accompanied by a diluent (Water for Injections).
Each 1.0 mL dose of the reconstituted vaccine contains no less than
2.5 International
Units (IU) of inactivated rabies virus, in accordance with the World
Health Organization
requirements.
This vaccine contains residues of polygeline, chicken proteins (e.g.,
ovalbumin) and
human serum albumin. The antibiotics neomycin, chlortetracycline and
amphotericin B
(amphotericin) are used in the manufacturing process of this vaccine
and may be present
in trace amounts.
The manufacture of this product includes exposure to bovine derived
materials. No
evidence exists that any case of vCJD (considered to be the human form
of bovine
spongiform encephalitis) has resulted from the administration of any
vaccine product.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For active immunisation against rabies virus in individuals of all
ages, including:
a)
Pre-exposure immunisation,
b)
Post-exposure treatment following exposure to rabies virus.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
Recommended dosages, as outlined below, are the same for children,
adolescents
and adults.
Administration
The vaccine must be given by intramuscular injection (IM) into the
deltoid muscle, or into
the anterolateral region of the thigh in small children. The vaccine
must not be given by
intragluteal injection.
For instructions on reconstitution of the