Intanza

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

Influenza virus haemagglutinin

Fáanlegur frá:

Sanofi-Aventis Australia Pty Ltd

Tegund:

Medicine Listed (Export Only)

Upplýsingar fylgiseðill

INTANZA
®

9µg/strain/0.1ml, suspension for injection in pre-filled syringe with
a Micro-Injection system
_Influenza Vaccine (split virion, inactivated)_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU ARE 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. 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:
What INTANZA 9 mcg is and what
it is used for
Before you use INTANZA 9 mcg
How to use INTANZA 9 mcg
Possible side effects
Storing INTANZA 9 mcg
Further information
WHAT INTANZA 9 MCG
IS USED FOR
INTANZA 9 mcg is a vaccine.
Vaccines are used to protect you
against infectious diseases.
This vaccine is recommended to help
to protect you against influenza.
The vaccine may be administered to
persons 18 to 59 years of age,
especially in those who run an
increased risk of associated
complications.
When an injection of INTANZA 9
mcg is given, the immune system
(body's natural defences) will induce
protection against Influenza
infection.
INTANZA 9 mcg will protect you
against Influenza infection from
about 2 to 3 weeks after the injection.
Influenza is a disease caused by
different types of virus and can
spread rapidly, especially in homes
or institutions where it is very easy to
catch and spread the infection. The
greatest risk of catching influenza is
during the cold months between May
and October. Your doctor will be
able to recommend you the best time
to be vaccinated. Influenza is present
every year even when epidemics or
outbreaks are not reported.
INTANZA 9 mcg should be used in
accordance with official
recommendations for influenza
vaccination.
The vaccine will only help to prevent
influenza if it is caused by one of the
three strains of virus contained in the
vaccine, or other

Vara einkenni

INTANZA Intradermal 9μg Dose Influenza Vaccine for
persons 18-59 years of age 
2013 season 

Page 1 of 10 

AUSTRALIAN PRODUCT INFORMATION 

NAME OF THE MEDICINE 
INTANZA 9μg/strain/0.1 mL suspension for injection in pre-filled syringe with a Micro-
Injection System. Influenza vaccine (split virion, inactivated). 

DESCRIPTION 
ACTIVE INGREDIENTS: 

Split  Influenza  virus*,  inactivated,  containing  antigens  equivalent  to  the  following 
strains: 

  A/CALIFORNIA/7/2009  (H1N1)PDM09-LIKE  STRAIN  (A/CALIFORNIA/7/2009  NYMC 
X-179A) 9 MICROGRAMS HA** 

  A/VICTORIA/361/2011  (H3N2)-LIKE  STRAIN  (A/VICTORIA/361/2011  IVR-165)  9 
MICROGRAMS HA** 

  B/WISCONSIN/1/2010  -LIKE  STRAIN  (B/HUBEI-WUJIAGANG/158/2009  NYMC  BX-
39) 9 MICROGRAMS HA** 
Per 0.1 mL dose 

* propagated in fertilised hens’ eggs from healthy chicken
flocks 
** haemagglutinin 

The  vaccine  complies  with  the  TGA  recommendations  (Southern  Hemisphere)  for  the 
2013 season. 

EXCIPIENTS: 

Buffer solution: 
• Sodium chloride 
• Potassium chloride 
• Sodium phosphate - dibasic dihydrate 
• Potassium phosphate - monobasic 
• Water for injections 

No  adjuvant  or  antimicrobial  preservative  is  added.  The  vaccine  does  not  contain  more 
than 0.05 microgram of ovalbumin per dose. In each dose the vaccine may contain traces 
of  octoxinol  9  (≤  150  microgram),  formaldehyde  (≤  0.6  microgram)  and  neomycin  (≤ 
0.05 picogram). 

The vaccine is  a colourless  and opalescent  suspension for injection in  pre-filled syringe 
with a Micro-Injection System. 
INTANZA Intradermal 9μg Dose Influenza Vaccine for
persons 18-59 years of age 
2013 season 

Page 2 of 10 

PHARMACOLOGY 
_MECHANISM OF ACTION _
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