Influvac sub-unit, suspension for injection (influenza vaccine, surface antigen, inactivated)

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Активный ингредиент:

A, GUANGDONG, MAONAN, SWL, HONG KONG, B, WASHINGTON

Доступна с:

Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

код АТС:

J07BB02

ИНН (Международная Имя):

A/GUANGDONG-MAONAN/SWL1536/2019 15 µg A/HONG KONG/2671/2019 15 µg B/WASHINGTON/02/2019 15 µg

Фармацевтическая форма:

SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

состав:

A/GUANGDONG-MAONAN/SWL1536/2019 15 µg A/HONG KONG/2671/2019 15 µg B/WASHINGTON/02/2019 15 µg

Тип рецепта:

POM

Терапевтические области:

VACCINES

Статус Авторизация:

Withdrawn

Дата Авторизация:

2007-06-27

тонкая брошюра

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PACKAGE LEAFLET: INFORMATION FOR THE USER
INFLUVAC SUB-UNIT, SUSPENSION FOR INJECTION
Influenza vaccine (surface antigen, inactivated)
2020/2021 season
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE
VACCINATED, BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU AND YOUR CHILD.
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Keep this leaflet. You may need to read it again.
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If you have any further questions, ask your doctor or pharmacist
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This vaccine has been prescribed for you or your child. Do not pass it
on to others.
-
If you or your child get any side effects, talk to your doctor or
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1 What Influvac is and what it is used for
2 What you need to know before you or your child use Influvac
3 How to use Influvac
4 Possible side effects
5 How to store Influvac
6 Contents of the pack and other information
1. WHAT INFLUVAC IS AND WHAT IT IS USED FOR
Influvac is a vaccine. This vaccine helps to protect you or your child
against influenza (flu),
particularly in people who run a high risk of associated
complications. The use of Influvac should be
based on official recommendations.
When a person is given the vaccine Influvac, 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.
Flu is a disease that can spread rapidly and is caused by different
types of strains that can change
every year. Therefore, this is why you or your child might need to be
vaccinated every year. The
greatest risk of catching flu is during the cold months between
October and March. If you or your
child were not vaccinated in the autumn, it is still sensible to be
vaccinated up until the spring since
you or your child runs the risk of catching flu until then. Your
doctor will be able to recommend the
best time to be vaccinated.
Influvac will protect you or your child against the three strains of
virus contained

Характеристики продукта

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Influvac sub-unit, suspension for injection (influenza vaccine,
surface antigen, inactivated).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (inactivated) (haemagglutinin and
neuraminidase) of the following
strains*:
- A/Guangdong-Maonan/SWL1536/2019 (H1N1)pdm09-like strain
(A/Guangdong-Maonan/SWL1536/2019, CNIC-1909)
15 micrograms HA **
- A/Hong Kong/2671/2019 (H3N2)-like strain
(A/Hong Kong/2671/2019, IVR-208)
15 micrograms HA **
- B/Washington/02/2019-like strain
(B/Washington/02/2019, wild type)
15 micrograms HA **
per 0.5 ml dose
*
propagated in fertilised hens’ eggs from healthy chicken flocks
** haemagglutinin.
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This vaccine complies with the World Health Organisation (WHO)
recommendation (northern
hemisphere) and EU recommendation for the 2020/2021 season.
For a full list of excipients see section 6.1.
Influvac sub-unit may contain traces of eggs (such as ovalbumin,
chicken proteins), formaldehyde,
cetyltrimethylammonium bromide, polysorbate 80 or gentamicin, which
are used during the
manufacturing process (see section 4.3).
3.
PHARMACEUTICAL FORM
Suspension for injection in prefilled syringe; a colourless clear
liquid, filled in single-dose syringes.
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4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Prophylaxis of influenza, especially those who run an increased risk
of associated complications.
Influvac sub-unit is indicated in adults and children from 6 months of
age.
The use of Influvac sub-unit should be based on official
recommendations.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: 0.5 ml.
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_Paediatric population _
Children from 36 months onwards: 0.5 ml.
Children from 6 months to 35 months: Clinical data are limited.
Dosages of 0.25 ml or 0.5 ml may
be given, for detailed instructions on administering a 0.25 ml or 0.5
ml dose, see section 6.6. The
dose given should be in accordance with existing national
recommendations.
For children, who have not previous