Intanza

Nchi: Nyuzilandi

Lugha: Kiingereza

Chanzo: Medsafe (Medicines Safety Authority)

Viambatanisho vya kazi:

Influenza virus A/California/7/2009 (H1N1) - like strain 9ug (A/California/7/2009 NYMC X-179A); Influenza virus A/Texas/50/2012 (H3N2) like strain 9ug (A/Texas/50/2012 NYMC X-223A); Influenza virus B/Massachusetts/2/2012 like strain 9ug (wild type)

Inapatikana kutoka:

sanofi-aventis new zealand limited

INN (Jina la Kimataifa):

Influenza virus A/California/7/2009 (H1N1) - like strain 9 µg (A/California/7/2009 NYMC X-179A)

Kipimo:

9 mcg

Dawa fomu:

Suspension for injection

Tungo:

Active: Influenza virus A/California/7/2009 (H1N1) - like strain 9ug (A/California/7/2009 NYMC X-179A) Influenza virus A/Texas/50/2012 (H3N2) like strain 9ug (A/Texas/50/2012 NYMC X-223A) Influenza virus B/Massachusetts/2/2012 like strain 9ug (wild type) Excipient: Dibasic sodium phosphate dihydrate Hydrochloric acid Monobasic potassium phosphate Potassium chloride Sodium chloride Sodium hydroxide Water for injection

Vitengo katika mfuko:

Syringe, glass, 0.1mL, 1 dose unit

Darasa:

Prescription

Dawa ya aina:

Prescription

Viwandani na:

Sanofi Pasteur SA

Matibabu dalili:

INTANZA 9mcg is indicated for prophylaxis of influenza in adults from 18 to 59 years of age. The use of INTANZA 9mcg in New Zealand should be based on the Ministry of Health recommendations for influenza vaccination as published in the current New Zealand Immunisation Handbook.

Bidhaa muhtasari:

Package - Contents - Shelf Life: Syringe, glass, 0.1mL - 1 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, 0.1mL - 10 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Idhini ya tarehe:

2009-07-07

Taarifa za kipeperushi

NEW ZEALAND 
CONSUMER MEDICINE INFORMATION 
INTANZA
®
, 9μg/strain/0.1ml, suspension for injection in pre-filled syringe 
with a Micro-Injection system 
Influenza Vaccine (split virion, inactivated) 
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 9ΜG is and what it is used for 
Before you use INTANZA 9ΜG   
How to use INTANZA 9ΜG 
Possible side effects 
Storing INTANZA 9ΜG 
Further information 
WHAT INTANZA 9ΜG IS AND WHAT IT IS USED FOR 
INTANZA 9ΜG 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 9ΜG is given, the immune
system (body's natural 
defences) will induce protection against Influenza infection. 
INTANZA 9ΜG will protect you against Influenza infection from about
2 to 3 weeks after 
the injection. 
Page 1 of 6 
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 9ΜG should be used in accordance with official
recommendations for 
influenza vaccination.

Tabia za bidhaa

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

           Page 1 of 10 

DATA SHEET 

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 

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