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

Nchi: Umoja wa Ulaya

Lugha: Kiingereza

Chanzo: EMA (European Medicines Agency)

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
06-10-2022
Tabia za bidhaa Tabia za bidhaa (SPC)
06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma (PAR)
07-07-2017

Viambatanisho vya kazi:

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

Inapatikana kutoka:

AstraZeneca AB

ATC kanuni:

J07BB03

INN (Jina la Kimataifa):

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

Kundi la matibabu:

Vaccines

Eneo la matibabu:

Influenza, Human

Matibabu dalili:

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

Bidhaa muhtasari:

Revision: 9

Idhini hali ya:

Authorised

Idhini ya tarehe:

2016-05-20

Taarifa za kipeperushi

                                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
                                
                                Soma hati kamili

Tabia za bidhaa

                                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
                                
                                Soma hati kamili

Bidhaa zinazofanana

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

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

ATC kanuni J07BB03

J07BB03

Mzalishaji au wazalishaji wadogowadogo AstraZeneca AB

AstraZeneca AB

INN (Jina la Kimataifa) pandemic influenza vaccine (H5N1) (live attenuated, nasal)

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

Nyaraka katika lugha zingine

Taarifa za kipeperushi Taarifa za kipeperushi Kibulgaria 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kibulgaria 06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kibulgaria 07-07-2017
Taarifa za kipeperushi Taarifa za kipeperushi Kihispania 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kihispania 06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kihispania 07-07-2017
Taarifa za kipeperushi Taarifa za kipeperushi Kicheki 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kicheki 06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kicheki 07-07-2017
Taarifa za kipeperushi Taarifa za kipeperushi Kidenmaki 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kidenmaki 06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kidenmaki 07-07-2017
Taarifa za kipeperushi Taarifa za kipeperushi Kijerumani 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kijerumani 06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kijerumani 07-07-2017
Taarifa za kipeperushi Taarifa za kipeperushi Kiestonia 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kiestonia 06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiestonia 07-07-2017
Taarifa za kipeperushi Taarifa za kipeperushi Kigiriki 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kigiriki 06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kigiriki 07-07-2017
Taarifa za kipeperushi Taarifa za kipeperushi Kifaransa 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kifaransa 06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kifaransa 07-07-2017
Taarifa za kipeperushi Taarifa za kipeperushi Kiitaliano 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kiitaliano 06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiitaliano 07-07-2017
Taarifa za kipeperushi Taarifa za kipeperushi Kilatvia 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kilatvia 06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kilatvia 07-07-2017
Taarifa za kipeperushi Taarifa za kipeperushi Kilithuania 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kilithuania 06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kilithuania 07-07-2017
Taarifa za kipeperushi Taarifa za kipeperushi Kihungari 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kihungari 06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kihungari 07-07-2017
Taarifa za kipeperushi Taarifa za kipeperushi Kimalta 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kimalta 06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kimalta 07-07-2017
Taarifa za kipeperushi Taarifa za kipeperushi Kiholanzi 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kiholanzi 06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiholanzi 07-07-2017
Taarifa za kipeperushi Taarifa za kipeperushi Kipolandi 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kipolandi 06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kipolandi 07-07-2017
Taarifa za kipeperushi Taarifa za kipeperushi Kireno 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kireno 06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kireno 07-07-2017
Taarifa za kipeperushi Taarifa za kipeperushi Kiromania 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kiromania 06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiromania 07-07-2017
Taarifa za kipeperushi Taarifa za kipeperushi Kislovakia 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kislovakia 06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kislovakia 07-07-2017
Taarifa za kipeperushi Taarifa za kipeperushi Kislovenia 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kislovenia 06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kislovenia 07-07-2017
Taarifa za kipeperushi Taarifa za kipeperushi Kifinlandi 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kifinlandi 06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kifinlandi 07-07-2017
Taarifa za kipeperushi Taarifa za kipeperushi Kiswidi 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kiswidi 06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiswidi 07-07-2017
Taarifa za kipeperushi Taarifa za kipeperushi Kinorwe 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kinorwe 06-10-2022
Taarifa za kipeperushi Taarifa za kipeperushi Kiaisilandi 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kiaisilandi 06-10-2022
Taarifa za kipeperushi Taarifa za kipeperushi Kroeshia 06-10-2022
Tabia za bidhaa Tabia za bidhaa Kroeshia 06-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kroeshia 07-07-2017

Tafuta arifu zinazohusiana na bidhaa hii

Taadhari Pandemic influenza vaccine H5N1 reassortant virus the following

Pandemic influenza vaccine H5N1 reassortant virus the following

Tazama historia ya hati

Historia ya nyaraka Historia ya nyaraka

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