INFLUVAC TETRA 15 Microgram Solution for injection in pre-filled syringe

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

A/MICHIGAN/45/2015 (H1N1) PDM09 - LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180A), A/HONG KONG/4801/2014 (H3N2) - LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013 -LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008 - LIKE STRAIN (B/BRISBANE/60/2008)

Доступно од:

Mylan Products Limited

АТЦ код:

J07BB02

INN (Међународно име):

A/MICHIGAN/45/2015 (H1N1) PDM09 - LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180A), A/HONG KONG/4801/2014 (H3N2) - LIKE STRAIN (A

Дозирање:

15 Microgram

Фармацеутски облик:

Solution for injection in pre-filled syringe

Тип рецептора:

Product subject to prescription which may not be renewed (A)

Терапеутска област:

Influenza vaccines

Статус ауторизације:

Authorised

Датум одобрења:

2017-08-25

Информативни летак

_Common EU PL Influvac Tetra _
_ _
_NL/H/3844/001 Sep2017 _
_ _
1/5
PACKAGE LEAFLET: INFORMATION FOR THE USER
INFLUVAC TETRA, SUSPENSION FOR INJECTION IN
PRE-FILLED SYRINGE
Influenza vaccine (surface antigen, inactivated)
2017/2018 season
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 YOU ARE VACCINATED, 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 pharmacist
-
This vaccine has been prescribed for you. Do not pass it on to others.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed
in this leaflet. See section 4.
IN THIS LEAFLET
1
What Influvac Tetra is and what it is used for
2
What you need to know before you use Influvac Tetra
3
How to use Influvac Tetra
4
Possible side effects
5
How to store Influvac Tetra
6
Contents of the pack and other information
1. WHAT INFLUVAC TETRA IS AND WHAT IT IS USED FOR
Influvac Tetra is a vaccine. This vaccine helps to protect you against
influenza (flu), particularly in subjects who
run a high risk of associated complications. Influvac Tetra is
prescribed for adults (18 years and older). The use
of Influvac Tetra should be based on official recommendations.
When a person is given the vaccine Influvac Tetra, 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 might need to be vaccinated every year. The
greatest risk of catching flu is during the
cold months between October and March. If you were not vaccinated in
the autumn,

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
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
Influvac Tetra, suspension for injection in pre-filled syringe
(influenza vaccine, surface antigen, inactivated).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (inactivated) (haemagglutinin and
neuraminidase) of the following strains*:
This vaccine complies with the World Health Organisation (WHO)
recommendation (northern hemisphere) and EU
recommendation for the 2017/2018 season.
For a full list of excipients see section 6.1.
Influvac Tetra 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 pre-filled syringe;
A colourless clear liquid, filled in single-dose syringes.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis of influenza, especially those who run an increased risk
of associated complications.
Influvac Tetra is indicated in adults (18 years of age and older).
The use of Influvac Tetra should be based on official recommendations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: 0.5 ml.
- A/Michigan/45/2015 (H1N1)pdm09-like strain
(A/Singapore/GP1908/2015, IVR-180)
15 micrograms HA **
- A/Hong Kong/4801/2014 (H3N2)-like strain
(A/Hong Kong/4801/2014, NYMC X-263B)
15 micrograms HA **
- B/Phuket/3073/2013-like strain
(B/Phuket/3073/2013, wild type)
15 micrograms HA **
-
B/Brisbane/60/2008-like strain
(B/Brisbane/60/2008, wild type)
15 micrograms HA **
per 0.5 ml dose
*
propagated in fertilised hens’ eggs from healthy chicken flocks
** haemagglutinin.
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