RABIES VACCINE CIPLA POWDER

Kraj: Republika Południowej Afryki

Język: angielski

Źródło: South African Health Products Regulatory Authority (SAHPRA)

Dostępny od:

Cipla Medpro (Pty) Ltd

Dawkowanie:

2,5 IU

Forma farmaceutyczna:

POWDER

Skład:

EACH 1,0 ml DOSE CONTAINS PURIFIED RABIES ANTIGEN (RABIES VIRUS PITMAN-MOORE STRAIN 3218) =2,5 IU

Status autoryzacji:

Registered

Ulotka dla pacjenta

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PATIENT INFORMATION LEAFLET
FOR RABIES VACCINE CIPLA
SCHEDULING STATUS
RABIES VACCINE CIPLA (2,5 IU Lyophilised powder for reconstitution)
Purified Rabies Antigen
(Rabies virus Pitman-Moore strain 3218- VERO)
Contains Sugar: sucrose 40 mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN RABIES VACCINE
CIPLA
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist, nurse
or other healthcare
provider.
WHAT IS IN THIS LEAFLET
1.
What is RABIES VACCINE CIPLA and what is used for:
2.
What you need to know before you are administered RABIES VACCINE
CIPLA.
3.
How to use RABIES VACCINE CIPLA.
4.
Possible side effects
5.
How to store RABIES VACCINE CIPLA
6.
Contents of the pack and other information.
1.
WHAT IS RABIES VACCINE CIPLA AND WHAT IT IS USED FOR
S4
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RABIES VACCINE CIPLA is a sterile, purified rabies vaccine injection.
It is a freeze-dried
powder that is to be reconstituted with a 1 mL diluent.
RABIES VACCINE CIPLA is indicated for the prevention of rabies in
adults and children. It
can be used before or after exposure to the rabies virus as well as a
booster dose.
_Pre-exposure prophylaxis _
RABIES VACCINE CIPLA is administered in people who are at risk of
being exposed to the
rabies virus, such as veterinarians, veterinary medicine students,
animal keepers, hunters,
forestry workers, animal handlers and other people who are at high
risk of exposure to rabies.
_Post-exposure prophylaxis _
RABIES VACCINE CIPLA is administered immediately to people who are
suspected to be
exposed to the rabies virus.
Table 1: Contact categories
CATEGORY
TYPE OF CONTACT
RECOMMENDED TREATMENT
I
Touching or feeding animals, licks on the
intact skin
No treatment is required, if a
reliable case history is
obtained.
II
Nibbling of uncovered skin, minor scratches
or abrasions without bleeding
Immediate vaccination
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III
Single or multiple transdermal bites or
scratches, contamination of mucous
membrane with saliva from licks, licks

Charakterystyka produktu

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PROFESSIONAL INFORMATION FOR
RABIES VACCINE CIPLA
SCHEDULING STATUS
1. NAME OF THE MEDICINE
RABIES VACCINE CIPLA (2,5 IU, Lyophilised powder for reconstitution)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
QUALITATIVE DECLARATION
RABIES VACCINE CIPLA (Freeze dried) is a sterile, purified inactivated
rabies vaccine
prepared on vero cells. Rabies Vaccine Inactivated is freeze dried and
is provided with a
single diluent (1 dose of powder in vial and 1 mL of diluent in
ampoule). The vaccine has
a milky white friable mass.
QUANTITATIVE DECLARATION
Each 1 mL dose of reconstituted vaccine contains:
Purified Rabies antigen (Rabies virus Pitman-Moore strain 3218) Vero
adapted and
grown on vero cells, inactivated with beta-propiolactone ≥ 2,5 IU.
RABIES VACCINE CIPLA contains sugar: 40 mg of sucrose.
For full list of excipients, see section 6.1.
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Page 2 of 18
3. PHARMACEUTICAL FORM
Lyophilised powder for reconstitution
The vaccine milky white friable mass appearance.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
RABIES VACCINE CIPLA is indicated for the prevention of rabies in all
age groups (adults
and children). It can be used before or after exposure, as a primary
immunisation or as a
booster dose (see sections 4.4 and 5.1).
PRE-EXPOSURE PROPHYLAXIS
Pre-exposure vaccination should be offered to people at high risk of
exposure to the
rabies virus. This vaccination is primarily recommended for
veterinarians, veterinary
medicine students, animal keepers, hunters, forestry workers, animal
handlers, butchers,
personnel working in rabies diagnostic and research laboratories as
well as children at a
high risk of exposure to rabies.
POST-EXPOSURE PROPHYLAXIS
RABIES VACCINE CIPLA is indicated for post-exposure prophylaxis of
rabies infection. It
should
be
administered
immediately
to
individuals
with
suspected
rabies
exposure.
Administration
of
RABIES
VACCINE
CIPLA
must
always
be
based
on
the
official
recommendations of the World Health Organization (WHO), depending on
the type of
exposure with a suspected r