Stamaril vaccine powder and solvent for suspension for injection 0.5ml vials

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Yellow fever virus strain 17D

Verfügbar ab:

Sanofi

ATC-Code:

J07BL01

INN (Internationale Bezeichnung):

Yellow fever virus strain 17D

Darreichungsform:

Powder and solvent for suspension for injection

Verabreichungsweg:

Subcutaneous

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 14040000; GTIN: 5015973333012

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
STAMARIL, POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION IN
PRE-FILLED SYRINGE
YELLOW FEVER VACCINE (LIVE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE
VACCINATED BECAUSE 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 or 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 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 so that an International Certificate of
Vaccination can be issued. This
certificate is valid from 10 days after the first dose of vaccine.
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 the doctor or nurse if any of the points below
apply to you or your child

Fachinformation

OBJECT 1
STAMARIL
Summary of Product Characteristics Updated 04-Jan-2018 | Sanofi
Pasteur
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
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 limpid
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 endemic area,
• 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.
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 and registered on
an International Certificate of Vaccination. The validity period of
this Certificate is established according
to International Health Regulations (IHR) recommendations, and starts
10 days after primary vaccination
and immediately after re-vaccination (see Section 4.2).
4.2 Posology and method of administration
Posology
• Primary vaccination
The vaccine should be given at least 10 days before entering an
endemic area since protective immunity
may not be achieved until at least this time has elapsed.
_Adu