STAMARIL Yellow fever vaccine, live, stabilised powder for injection vial and diluent syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Yellow fever virus, Quantity: 1000 PFU e.1000 mouse LD50

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: calcium chloride dihydrate; magnesium sulfate heptahydrate; histidine hydrochloride; sodium chloride; dibasic sodium phosphate dihydrate; alanine; sorbitol; potassium chloride; lactose monohydrate; monobasic potassium phosphate; sodium hydroxide

Administration route:

Subcutaneous, Intramuscular

Units in package:

single dose diluent syringe, single dose vial

Prescription type:

Not scheduled. Not considered by committee, (S4) Prescription Only Medicine

Therapeutic indications:

Prevention of yellow fever. Vaccination is recommended for:,? Every individual aged 9 months and over living or travelling through an endemic area with a current or periodic risk of yellow fever transmission. ? Non-vaccinated individual moving from an endemic area with a current or periodic risk of yellow fever transmission to a potentially receptive non-endemic area with a current or periodic risk of yellow fever transmission. ? Laboratory workers handling potentially infectious materials. In order to be officially recognised, the yellow fever vaccination must be administered in an approved vaccination centre and registered on an international certificate. The validity period of the certificate is established according to International Health Regulations recommendations and starts 10 days after primary vaccination and immediately after re-vaccination.

Product summary:

Visual Identification: Lyophilised plug prior to reconstitution. After reconstitution the vaccine is an opalescent beige to beige-pink solution.; Container Type: Vial; Container Material: Other composite material; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1998-05-14

Patient Information leaflet

STAMARIL
®
_YELLOW FEVER VACCINE (LIVE)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU OR YOUR CHILD IS
VACCINATED.
•
Keep this leaflet. You may need
to read it again.
•
If you have any further questions,
ask your doctor or pharmacist.
•
This vaccine has been prescribed
for you or your child. Do not pass
it on to others.
•
If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or
pharmacist.
IN THIS LEAFLET:
•
What STAMARIL is and what it
is used for
•
Before you or your child is given
STAMARIL
•
How STAMARIL is given
•
Possible side effects
•
Storing STAMARIL
•
Further Information
WHAT STAMARIL IS
AND WHAT IT IS USED FOR
STAMARIL is a vaccine that
provides protection against a serious
infectious disease called yellow
fever.
Yellow fever occurs in certain areas
of the world and is spread to people
through the bites of infected
mosquitoes.
STAMARIL is given to people who:
•
are travelling to, passing through
or living in an area where yellow
fever is present or may be
present,
•
are travelling to any country that
requires an International
Certificate of Vaccination for
entry, this may depend on the
countries previously visited
during the same trip,
•
may handle infectious materials
such as laboratory workers.
To obtain a vaccination certificate
against yellow fever it is necessary to
be vaccinated in an approved
vaccination centre by a qualified and
trained health care professional so
that an International Certificate of
Vaccination can be issued. This
certificate is valid from the 10th day
after the vaccination.
BEFORE YOU OR YOUR
CHILD IS GIVEN
STAMARIL
_STAMARIL SHOULD NOT BE_
_GIVEN IF YOU OR YOUR CHILD:_
•
women who are pregnant or
breast-feeding,
•
children under 6 months of age,
•
is allergic to eggs, chicken
proteins or any other ingredient of
STAMARIL,
•
has experienced a serious reaction
after an injection of a yellow
fever vaccine,
•
has an il

Summary of Product characteristics

sta-ccdsv11-piv5-16sep20
Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION – STAMARIL
® (YELLOW
FEVER VIRUS) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Yellow Fever Vaccine (Live)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mL dose of reconstituted vaccine from the freeze-dried
product contains an injectable
suspension in stabiliser of the attenuated 17D strain of yellow fever
virus. The virus has been
propagated in specific pathogen-free chick embryos, in particular free
from avian leucosis
viruses. Each dose contains not less than 1000 IU.
Stamaril meets the World Health Organization (WHO) requirements for
manufacture of
biological substances.
The manufacture of this product includes exposure to bovine materials.
No evidence exists that
any case of vCJD (considered to be the human form of bovine spongiform
encephalopathy) 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 diluent for suspension for injection.
Stamaril is a beige to orange beige and homogenous powder, which after
reconstitution with
sodium chloride solution (a clear and colourless solution) forms a
beige to pinked beige
suspension, more or less opalescent.
_ _
_ _
_ _
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of yellow fever. Vaccination is recommended for:
•
Every individual aged 9 months and over living or travelling through
an endemic area
where there is a current or periodic risk of yellow fever
transmission.
•
Non-vaccinated individual moving from an endemic area where there is a
current or periodic risk of yellow fever transmission to a potentially
receptive
non-endemic area
where there is a current or periodic risk of yellow fever
transmission
.
•
Laboratory workers handling potentially infectious materials.
In order to be officially recognised, the yellow fever vaccination
must be administered in an
approved vaccination centre by a qualified and trained health care
professional and registered
on