STAMARIL, powder and solvent for suspension for injection in pre-filled syringe.Yellow fever vaccine (Live)

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Yellow fever virus 17 d-204 strain

Available from:

Sanofi Pasteur

ATC code:

J07BL; J07BL01

INN (International Name):

Yellow fever virus 17 d-204 strain

Dosage:

1000 international unit(s)

Pharmaceutical form:

Powder and solvent for suspension for injection in pre-filled syringe

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Yellow fever vaccines; yellow fever, live attenuated

Authorization status:

Marketed

Authorization date:

1999-09-07

Patient Information leaflet

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 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 YO

Summary of Product characteristics

Health Products Regulatory Authority
28 January 2021
CRN009LPR
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
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 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 Certificat