Celvapan

Land: Europäische Union

Sprache: Englisch

Quelle: EMA (European Medicines Agency)

Wirkstoff:

Whole virion influenza vaccine, inactivated containing antigen of strain A/California/07/2009 (H1N1)v

Verfügbar ab:

Nanotherapeutics Bohumil, s.r.o.

ATC-Code:

J07BB01

INN (Internationale Bezeichnung):

influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated)

Therapiegruppe:

Vaccines

Therapiebereich:

Disease Outbreaks; Influenza, Human; Immunization

Anwendungsgebiete:

Prophylaxis of influenza caused by A(H1N1)v 2009 virus.Celvapan should be used in accordance with official guidance.

Produktbesonderheiten:

Revision: 11

Berechtigungsstatus:

Withdrawn

Berechtigungsdatum:

2009-03-04

Gebrauchsinformation

24
B. PACKAGE LEAFLET
Medicinal product no longer authorised
25
PACKAGE LEAFLET: INFORMATION FOR THE USER
CELVAPAN SUSPENSION FOR INJECTION
Influenza vaccine (H1N1)v (whole virion, Vero cell derived,
inactivated)
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 you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Celvapan is and what it is used for
2.
What you need to know before you receive Celvapan
3.
How Celvapan is given
4.
Possible side effects
5.
How to store Celvapan
6.
Contents of the pack and other information
1.
WHAT CELVAPAN IS AND WHAT IT IS USED FOR
Celvapan is a vaccine to prevent influenza (flu) caused by A(H1N1)v
2009 virus
When a person is given the vaccine, the immune system (the body’s
natural defense 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 CELVAPAN
YOU SHOULD NOT RECEIVE CELVAPAN:

if you previously had a sudden life-threatening allergic reaction to
any ingredient of Celvapan
or to any of the substances that may be present in trace amounts as
follows: formaldehyde,
benzonase, sucrose.
-
Signs of an allergic reaction may include itchy skin rash, shortness
of breath and swelling
of the face or tongue.
If you are not sure, talk to your doctor or nurse before having this
vaccine.
TAKE SPECIAL CARE WITH CELVAPAN:
Check with your doctor or nurse before you are given Celvapan if

you have had any allergic reaction other than a sudden
life-threatening allergic reaction to any
ingredient contained in the vaccine, to formaldehyde, benzonase, or to
sucrose. (see section 6.
Further information).

you have a severe infection with a high temperature (over 38 °C). I

Fachinformation

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Celvapan suspension for injection
Influenza vaccine (H1N1)v (whole virion, Vero cell derived,
inactivated)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Whole virion influenza vaccine, inactivated containing antigen of
strain *:
A/California/07/2009 (H1N1)v
7.5 micrograms**
per 0.5 ml dose
*
propagated in Vero cells (continuous cell line of mammalian origin)
**
expressed in micrograms haemagglutinin.
This is a multidose container. See section 6.5 for the number of doses
per vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
The vaccine is a clear to opalescent, translucent suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of influenza caused by A(H1N1)v 2009 virus (See section
4.4).
Celvapan should be used in accordance with Official Guidance
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
The dose recommendations take into account available data from
clinical studies in healthy subjects
who received two doses of Celvapan (H1N1)v.
From clinical studies limited immunogenicity and safety data are
available for Celvapan (H1N1)v in
healthy adult and older subjects and in children (see section 4.4,
4.8, and 5.1).
Adults and older people
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.
Children and adolescents aged 3 to 17 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.
Children aged 6 to 35 months
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.
Medicinal product no longer authorised
3
Children aged less than 6 months
Vaccination is not currently recommended in this age group.
For further information, see sections 4.8 and 5.1.
It is recommended that subjects who receive a first dose of Celvapa