Focetria

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/California/7/2009 (H1N1)-derived strain used NYMC X-181

Available from:

Novartis Vaccines and Diagnostics S.r.l.

ATC code:

J07BB02

INN (International Name):

influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)

Therapeutic group:

Influenza vaccines

Therapeutic area:

Influenza, Human; Immunization; Disease Outbreaks

Therapeutic indications:

Prophylaxis of influenza caused by A (H1N1v) 2009 virus.Focetria should be used in accordance with official guidance.

Product summary:

Revision: 9

Authorization status:

Withdrawn

Authorization date:

2007-05-02

Patient Information leaflet

35
B. PACKAGE LEAFLET
Medicinal product no longer authorised
36
PACKAGE LEAFLET: INFORMATION FOR THE USER
FOCETRIA SUSPENSION FOR INJECTION
Influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)
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.
-
If any of the side effects gets serious, talk to your doctor. This
includes any possible side effects
not listed in this leaflet.
WHAT IS IN THIS LEAFLET
:
1.
What Focetria is and what it is used for
2.
What you need to know before you receive Focetria
3.
How Focetria is given
4.
Possible side effects
5.
How to store Focetria
6.
Contents of the pack and other information
1.
WHAT FOCETRIA IS AND WHAT IT IS USED FOR
Focetria is a vaccine to prevent influenza (flu) caused by A(H1N1v)
2009 virus.
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
ingredient in the vaccine can cause flu.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE FOCETRIA
DO NOT RECEIVE FOCETRIA:

if you have previously had a sudden life-threatening allergic reaction
to any ingredient of
Focetria (these are listed at the end of the leaflet) or to any of the
substances that may be present
in trace amounts as follows: egg and chicken protein, ovalbumin,
formaldehyde, kanamycin and
neomycin sulphate (antibiotics) or cetyltrimethylammonium bromide
(CTAB). Signs of an allergic
reaction may include itchy skin rash, shortness of breath and swelling
of the face or tongue.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR NURSE BEFORE RECEIVING FOCETRIA
TAKE SPECIAL CARE WITH FOCETRIA:

if you have had any allergic reaction other than a sudden
life-threatening allergic reaction to any
ingredient contained in the vaccine, to thiomersal (only for the
multidose vial presentation),
to egg and, chicken protein

Summary of Product characteristics

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Focetria suspension for injection in pre-filled syringe
Influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (haemagglutinin and neuraminidase)*
of strain:
A/California/07/2009 (H1N1)-derived strain used NYMC X-181
7.5 micrograms** per 0.5 ml dose
* propagated in eggs
** expressed in microgram haemagglutinin.
Adjuvant MF59C.1 containing:
squalene
9.75 milligrams
polysorbate 80
1.175 milligrams
sorbitan trioleate
1.175 milligrams
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
Milky-white liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of influenza caused by A (H1N1v) 2009 virus (see section
4.4).
Focetria should be used in accordance with Official Guidance.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The dose recommendations take into account the safety and
immunogenicity data from clinical studies
in healthy subjects.
Posology
Adults (18-60 years):
One dose of 0.5 ml at an elected date.
Immunogenicity data obtained at three weeks after one dose of Focetria
H1N1v suggest that a single
dose may be sufficient.
If a second dose is administered there should be an interval of at
least three weeks between the first
and second dose.
Elderly (>60 years):
One dose of 0.5 ml at an elected date.
A second dose of vaccine should be given after an interval of at least
three weeks.
_Paediatric population _
Medicinal product no longer authorised
3
Children and adolescents aged 3-17 years:
One dose of 0.5 ml at an elected date.
Immunogenicity data obtained at three weeks after one dose of Focetria
H1N1v suggest that a single
dose may be sufficient. If a second dose is administered there should
be an interval of at least three
weeks between the first and second dose.
Children aged 6 months to 35 months
:
One dose of 0.5 ml at a