Stamaril Powder+Solvent for Susp for Injection in pre-filled syringe, Yellow fever vaccine (Live)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

YELLOW FEVER, VIRUS STRAIN, D

Available from:

Sanofi Pasteur 14 Espace Henry Vallée , 69007 Lyon, France

ATC code:

J07BL01

INN (International Name):

YELLOW FEVER VIRUS STRAIN 17D 1000 IU

Pharmaceutical form:

POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Composition:

YELLOW FEVER VIRUS STRAIN 17D 1000 IU

Prescription type:

POM

Therapeutic area:

VACCINES

Authorization status:

Authorised

Authorization date:

2007-03-26

Patient Information leaflet

PAGE 1 OF 8
PACKAGE LEAFLET
PAGE 2 OF 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
STAMARIL, POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION IN
PRE-FILLED SYRINGE
YELLOW FEVER VACCINE (LIVE)
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your healthcare professional.
-
This vaccine has been prescribed for you or your child only. Do not
pass it on to others.
-
If you get any side effects talk to your healthcare professional and
tell them that you received yellow
fever vaccine. This includes any possible side effects not listed in
this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET
1.
What STAMARIL is and what it is used for
2.
What you need to know before you or your child use STAMARIL
3.
How to use STAMARIL
4.
Possible side effects
5.
How to store STAMARIL
6.
Contents of the pack and other information
1.
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 man
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 occurs,
-
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 valid vaccination certificate against yellow fever, it is
necessary to be vaccinated in an approved
vaccination centre
by a qualified and trained healthcare professional so that an
International Certificate of
Vaccination can be issued. This certificate is valid from 10 days
after the first dose of vaccine. In some
circumstances, when a booster is needed, the certificate (see Section
3) is valid immediately after the
injection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD USE STAMARIL
It is important to tell your heal

Summary of Product characteristics

PAGE 1 OF 12
SUMMARY OF PRODUCT CHARACTERISTICS
PAGE 2 OF 12
1
NAME OF THE MEDICINAL PRODUCT
STAMARIL, powder and solvent for suspension for injection in
pre-filled syringe.
Yellow fever vaccine (Live).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 mL) contains:
Yellow fever virus
1
17D-204 strain (live, attenuated)
........................................... not less than 1000 IU
1
produced in specified pathogen-free chick embryos
Excipients with known effects:
This product contains approximately 8 mg of sorbitol (E420) per dose.
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Powder and solvent for suspension for injection.
Before reconstitution, the powder is homogeneous, beige to orange
beige, and the solvent is a clear
and colorless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
STAMARIL is indicated for active immunization against yellow fever in
persons:
•
travelling to, passing through or living in an area where there is a
current or periodic risk of
yellow fever transmission.
•
travelling to any country that requires an International Certificate
of Vaccination for entry (which
may or may not depend on the previous itinerary),
•
handling potentially infectious materials (
_e.g._
laboratory personnel).
See Sections 4.2, 4.3 and 4.4 regarding the minimum age for
vaccination of children under special
circumstances and guidance for vaccination of other specific patient
populations.
For updated yellow fever vaccination requirements and recommendations
consult the WHO dedicated
website or refer to resources provided by national health authorities.
In order to comply with vaccine regulations and to be officially
recognized, yellow fever vaccines
must be administered in an approved World Health Organization (WHO)
vaccination centre by a
qualified and trained health care professional and registered on an
International Certificate of
Vaccination. The validity period of this Certificate is established
according to International Health
Regulat