INFLUVAC SUB-UNIT 0.5 Microgram Suspension for Injection

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/CALIFORNIA/7/2009, X-181), A/HONG KONG/4801/2014 (H3N2) - LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008 - LIKE STRAIN (B/BRISBANE/60/2008)

Tersedia dari:

BGP Products Ltd

Kode ATC:

J07BB02

INN (Nama Internasional):

A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/CALIFORNIA/7/2009, X-181), A/HONG KONG/4801/2014 (H3N2) - LIKE STRAIN (A/HONG KON

Dosis:

0.5 Microgram

Bentuk farmasi:

Suspension for Injection

Jenis Resep:

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

Area terapi:

Influenza vaccines

Status otorisasi:

Transfer Pending

Tanggal Otorisasi:

2015-01-30

Selebaran informasi

1105121
PACKAGE LEAFLET: INFORMATION FOR THE USER
INFLUVAC® SUB-UNIT, SUSPENSION FOR INJECTION
(influenza vaccine surface antigen, inactivated)
2016/2017season 
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE
VACCINATED, BECAUSE IT 
CONTAINS IMPORTANT INFORMATION FOR YOU AND YOUR CHILD.  
-  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 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.
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

Karakteristik produk

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 (haemagglutinin and neuraminidase) of the following strains*:
- A/California/7/2009 (H1N1)pdm09-like strain (A/California/7/2009, X-181)
15 micrograms HA **
- A/Hong Kong/4801/2014 (H3N2)-like strain (A/Hong Kong/4801/2014, X-263B)
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.
This vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU
recommendation for the 2016/2017 season.
For a full list of excipients see section 6.1.
Influvac 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 syringes; a colourless clear liquid, filled in single-dose syringes (glass, type I).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis of influenza, especially those who run an increased risk of associated complications.
Influvac is indicated in adults and children from 6 months of age.
The use of Influvac should be based on official recommendations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: 0.5 ml.
_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, se