AGRIPPAL Suspension for Injection

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181) A/TEXAS/50/2012 (H3N2) DERIVED STRAIN USED (NYMC X-233A) B/MASSACHUSETTS/2/2012-LIKE STRAIN USED B/MASSACHUSETTS/2/2012 WILD TYPE

Saatavilla:

Novartis Vaccines and Diagnostics S.r.l.

INN (Kansainvälinen yleisnimi):

A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181) A/TEXAS/50/2012 (H3N2) DERIVED STRAIN USED (NYMC X-233A) B/MAS

Lääkemuoto:

Suspension for Injection

Prescription tyyppi:

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

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

0000-00-00

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER 
AGRIPPAL, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 

INFLUENZA VACCINE (SURFACE ANTIGEN, INACTIVATED) 
_ _ 

READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU OR YOUR CHILD IS VACCINATED. 

- 
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 any of the side effects gets serious, or if you
notice any side effects not listed in this 
leaflet, please tell your doctor or pharmacist. 

IN THIS LEAFLET:  

1. 
WHAT AGRIPPAL IS AND WHAT IT IS USED FOR 
2. 
BEFORE YOU OR YOUR CHILD USES AGRIPPAL 
3. 
HOW TO USE AGRIPPAL 
4. 
POSSIBLE SIDE EFFECTS 
5. 
  HOW TO STORE AGRIPPAL 
6. 
FURTHER INFORMATION 

1. 
WHAT AGRIPPAL IS AND WHAT IT IS USED FOR 

Agrippal is a vaccine. This vaccine helps to protect you
or your child against influenza (flu), 
particularly in subjects who run a high risk of associated
complications. The use of Agrippal 
should be based on official recommendations. 

When a person is given the vaccine Agrippal, 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 was 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. 

A

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
AGRIPPAL, Suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated)
(2014/2015 SEASON)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (haemagglutinin and neuraminidase), of the following strains*:
A/California/7/2009 (H1N1)pdm09 – derived strain used (NYMC X-181)
15 micrograms HA**
A/Texas/50/2012 (H3N2) – derived strain used (NYMC X-223)
15 micrograms HA**
B/Massachusetts/2/2012 – (wild type)
15 micrograms HA**
Per 0.5 ml dose
* propagated in fertilized hens’ eggs from healthy chicken flocks
** haemagglutinin
This vaccine complies with the WHO recommendations (northern hemisphere) and EU decision for the 2014/2015
season.
Excipients:
For a full list of excipients see section 6.1
Agrippal may contain traces of eggs such as ovalbumin or chicken proteins, kanamycin and neomycin sulphate,
formaldehyde, cetyltrimethylammonium bromide (CTAB), polysorbate 80 and barium sulphate which are used during
the manufacturing process (see section 4.3).
3 PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
The vaccine appears as a clear liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis of influenza, especially in those who run an increased risk of associated complications.
Agrippal is indicated in adults and children from 6 months of age.
The use of AGRIPPAL should be based on official recommendations.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 28/08/2014_
_CRN 2148211_
_page number: 1_
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 t