Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune)

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain

Available from:

AstraZeneca AB

ATC code:

J07BB03

INN (International Name):

pandemic influenza vaccine (H5N1) (live attenuated, nasal)

Therapeutic group:

Vaccines

Therapeutic area:

Influenza, Human

Therapeutic indications:

Prophylaxis of influenza in an officially declared pandemic situation in children and adolescents from 12 months to less than 18 years of age.Pandemic influenza vaccine H5N1 AstraZeneca should be used in accordance with official guidance

Product summary:

Revision: 9

Authorization status:

Authorised

Authorization date:

2016-05-20

Patient Information leaflet

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE USER
PANDEMIC INFLUENZA VACCINE H5N1 ASTRAZENECA, NASAL SPRAY SUSPENSION
Pandemic influenza vaccine (H5N1) (live attenuated, nasal)
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 THE VACCINE IS GIVEN BECAUSE
IT CONTAINS IMPORTANT
INFORMATION FOR YOU OR YOUR CHILD.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, nurse or
pharmacist.
-
This vaccine has been prescribed for you or your child only. Do not
pass it on to others.
-
If any of the side effects gets serious, talk to your doctor, nurse or
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Pandemic influenza vaccine H5N1 AstraZeneca is and what it is
used for
2.
What you need to know before you are given Pandemic influenza vaccine
H5N1 AstraZeneca
3.
How Pandemic influenza vaccine H5N1 AstraZeneca is given
4.
Possible side effects
5.
How to store Pandemic influenza vaccine H5N1 AstraZeneca
6.
Contents of the pack and other information
1.
WHAT PANDEMIC INFLUENZA VACCINE H5N1 ASTRAZENECA IS AND WHAT IT IS
USED FOR
Pandemic influenza vaccine H5N1 AstraZeneca is a vaccine to prevent
influenza (flu) in an officially
declared pandemic. It is used in children and adolescents 12 months to
less than 18 years of age.
Pandemic flu is a type of influenza that happens at intervals that
vary from less than 10 years to many
decades. It spreads rapidly around the world. The signs of pandemic
flu are similar to those of ordinary
flu but may be more serious.
HOW PANDEMIC INFLUENZA VACCINE H5N1 ASTRAZENECA WORKS
Pandemic influenza vaccine H5N1 AstraZeneca is similar to Fluenz Tetra
(a nasal influenza vaccine
containing four strains), except Pandemic influenza vaccin

Summary of Product characteristics

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
Pandemic influenza vaccine H5N1 AstraZeneca nasal spray, suspension
Pandemic influenza vaccine (H5N1) (live attenuated, nasal)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.2 ml) contains:
Reassortant influenza virus* (live attenuated) of the following
strain**:
A/Vietnam/1203/2004 (H5N1) strain
(A/Vietnam/1203/2004, MEDI 0141000136)
10
7.0±0.5
FFU***
*
propagated in fertilised hens’ eggs from healthy chicken flocks.
**
produced in VERO cells by reverse genetic technology. This product
contains a genetically
modified organism (GMO).
***
fluorescent focus units
This vaccine complies with the WHO recommendation and EU decision for
the pandemic.
The vaccine may contain residues of the following substances: egg
proteins (e.g. ovalbumin) and
gentamicin. The maximum amount of ovalbumin is less than 0.024
micrograms per 0.2 ml dose (0.12
micrograms per ml).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, suspension
The suspension is colourless to pale yellow, clear to opalescent with
a pH of approximately 7.2. Small
white particles may be present.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of influenza in an officially declared pandemic situation
in children and adolescents
from 12 months to less than 18 years of age.
Pandemic influenza vaccine H5N1 AstraZeneca should be used in
accordance with official guidance.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Children and adolescents from 12 months to less than 18 years of age_
0.2 ml (administered as 0.1 ml per nostril).
Two doses are recommended for all children and adolescents. The second
dose should be administered
after an interval of at least 4 weeks.
_Childre