Pandemrix

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

split influenza virus inactivated, containing antigen equivalent to A/California/07/2009 (H1N1)-derived strain used NYMC X-179A

MAH:

GlaxoSmithKline Biologicals S.A.

ATC_code:

J07BB02

INN:

influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)

therapeutic_group:

Influenza vaccines

therapeutic_area:

Influenza, Human; Immunization; Disease Outbreaks

therapeutic_indication:

Prophylaxis of influenza caused by A (H1N1)v 2009 virus. Pandemrix should only be used if the recommended annual seasonal trivalent / quadrivalent influenza vaccines are not available and if immunisation against (H1N1)v is considered necessary (see sections 4.4 and 4.8).Pandemrix should be used in accordance with Official Guidance.

leaflet_short:

Revision: 23

authorization_status:

Withdrawn

authorization_date:

2008-05-20

PIL

35
B. PACKAGE LEAFLET
36
PACKAGE LEAFLET: INFORMATION FOR THE USER
PANDEMRIX SUSPENSION AND EMULSION FOR EMULSION FOR INJECTION
Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE THIS VACCINE
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 or nurse.
-
This vaccine has been prescribed for you only. Do not pass it on to
others.
-
If you get any of side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Pandemrix is and what it is used for
2.
What you need to know before you receive Pandemrix
3.
How Pandemrix is given
4.
Possible side effects
5.
How to store Pandemrix
6.
Contents of the pack and other information
1.
WHAT PANDEMRIX IS AND WHAT IT IS USED FOR
WHAT PANDEMRIX IS AND WHAT IT IS USED FOR
Pandemrix is a vaccine to prevent influenza (flu) caused by A(H1N1)v
2009 virus.
Your doctor will normally recommend a different vaccine (annual
trivalent/quadrivalent influenza
vaccine) instead of Pandemrix, but if the trivalent/quadrivalent
vaccines are not available Pandemrix may
still be an option if you need protection against A(H1N1)v influenza
(see Take special care with
Pandemrix).
HOW PANDEMRIX WORKS
When a person is given the vaccine, the immune system (the body’s
natural defence system) will produce
its own protection (antibodies) against the disease. None of the
ingredients in the vaccine can cause flu.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE PANDEMRIX
PANDEMRIX SHOULD NOT BE GIVEN:
•
if you have previously had a sudden life-threatening allergic reaction
to any ingredient of this
vaccine (listed in section 6) or

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of new
safety information. Healthcare professionals are asked to report any
suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Pandemrix suspension and emulsion for emulsion for injection.
Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After mixing, 1 dose (0.5 ml) contains:
Split influenza virus, inactivated, containing antigen
*
equivalent to:
_ _
A/California/07/2009 (H1N1) derived strain used NYMC X-179A
3.75 micrograms
**
*
propagated in eggs
**
haemagglutinin
AS03 adjuvant composed of squalene (10.69 milligrams), DL-
α
-tocopherol (11.86 milligrams) and
polysorbate 80 (4.86 milligrams)
The suspension and emulsion, once mixed, form a multidose vaccine in a
vial. See section 6.5 for the
number of doses per vial.
Excipient with known effect
The vaccine contains 5 micrograms thiomersal
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension and emulsion for emulsion for injection.
The suspension is a colourless light opalescent liquid.
The emulsion is a whitish to yellowish homogeneous milky liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of influenza caused by A (H1N1)v 2009 virus. Pandemrix
should only be used if the
recommended annual seasonal trivalent/quadrivalent influenza vaccines
are not available and if
immunisation against (H1N1)v is considered necessary (see sections 4.4
and 4.8).
Pandemrix should be used in accordance with Official Guidance.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
3
The dose recommendations take into account the safety and
immunogenicity data from clinical studies in
healthy subjects
See sections 4.4, 4.8 and 5.1 for details.
No data are available in children aged less than 6 months.
_Adults aged 18 years and older: _
One dose of 0.5 ml at an elected dat