Pandemic Influenza Vaccine H5N1 Baxter

البلد: نيوزيلاندا

اللغة: الإنجليزية

المصدر: Medsafe (Medicines Safety Authority)

العنصر النشط:

Influenza vaccine whole virion, vero cell derived, inactivated 7.5ug (A(H5N1) (A/Vietnam/1203/2004));  

متاح من:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (الاسم الدولي):

Influenza vaccine whole virion, vero cell derived, inactivated 7.5 µg (A(H5N1) (A/Vietnam/1203/2004))

جرعة:

7.5 mcg/0.5mL

الشكل الصيدلاني:

Suspension for injection

تركيب:

Active: Influenza vaccine whole virion, vero cell derived, inactivated 7.5ug (A(H5N1) (A/Vietnam/1203/2004))   Excipient: Polysorbate 80 Sodium chloride Trometamol Water for injection

الوحدات في الحزمة:

Syringe, glass, 1 x single dose syringe, 1 dose unit

الفئة:

Prescription

نوع الوصفة الطبية :

Prescription

المصنعة من قبل:

Baxter AG

الخصائص العلاجية:

Prophylaxis of influenza in an officially declared pandemic situation. The vaccine may only be marketed or distributed in accordance with the directives contained in the current version of the New Zealand Influenza Pandemic Action Plan.

ملخص المنتج:

Package - Contents - Shelf Life: Syringe, glass, 1 x single dose syringe - 1 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, multi-dose, 10mL clear Type I with bromobutyl rubber stopper. 10 x 0.5mL doses per vial, 20 vials per pack - 200 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 3 hours opened stored at or below 25°C

تاريخ الترخيص:

2008-06-23

خصائص المنتج

PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 
New Zealand Data Sheet 

PANDEMIC INFLUENZA VACCINE H5N1 Data Sheet 14 August 2012 
 Page 1 of 15 
Baxter 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 
_WHOLE VIRION, VERO CELL DERIVED, INACTIVATED, _
_SUSPENSION FOR INJECTION _
QUALITATIVE & QUANTITATIVE COMPOSITION 
Suspension for injection. 
One dose of 0.5mL contains: 
Whole virion, non-adjuvanted influenza vaccine, inactivated,
containing antigen
†
 of strain: 
A/Vietnam/1203/2004 (H5N1) 7.5 micrograms*. 
†
   propagated in Vero cells (continuous cell line of
mammalian origin) 
* expressed in micrograms haemagglutinin. 
This vaccine complies with the WHO recommendation and EU decision for
the pandemic. 
This vaccine is either available in a single dose pre-filled syringe
or in a multidose container, _see _
_Pharmaceutical Particulars/Nature and Contents of the
Container _for the number of doses per vial. 
For a full list of excipients, see _Pharmaceutical Particulars/List
of Excipients._ 
PHARMACEUTICAL FORM 
Suspension for injection.  The H5N1 vaccine is a clear to
 opalescent, translucent suspension.  
CLINICAL PARTICULARS 
_THERAPEUTIC INDICATIONS _
Prophylaxis of influenza in an officially declared pandemic situation.

The vaccine may only be marketed or distributed in accordance with
the directives contained in the 
current version of the New Zealand Influenza Pandemic Action Plan. 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER has been evaluated in adults 18
- 59 years 
of age and in elderly 60 years of age and above.  
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 
New Zealand Data Sheet 

PANDEMIC INFLUENZA VACCINE H5N1 Data Sheet 14 August 2012 
 Page 2 of 15 
Baxter 
_DOSAGE AND METHOD OF ADMINISTRATION _
ADULTS (18 YEARS AND OLDER) 
First dose of 0.5mL at an elected date.  
A second dose of vaccine should be given after an interval of at
least 3 weeks. 
Immunization should be carried out by intramuscular injection
into