Advate

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Octocog alfa 3000 [iU];  

Available from:

Takeda New Zealand Limited

INN (International Name):

Octocog alfa 3000 IU

Dosage:

3000 IU

Pharmaceutical form:

Injection with diluent

Composition:

Active: Octocog alfa 3000 [iU]   Excipient: Calcium chloride dihydrate Glutathione Histidine Mannitol Polysorbate 80 Sodium chloride Trehalose dihydrate Trometamol Water for injection

Units in package:

Combination pack, 1 vial active + 1 vial diluent + 1 BaxJect II, 5 mL

Class:

General sale

Prescription type:

General sale

Manufactured by:

Baxalta Manufacturing Sarl

Therapeutic indications:

ADVATE is indicated for use in haemophilia A for prevention and control of haemorrhagic episodes. Patients with haemophilia A may be treated with ADVATE as perioperative management. ADVATE is not indicated in von Willebrand's disease.

Product summary:

Package - Contents - Shelf Life: Combination pack, 1 vial active + 1 vial diluent + 1 BaxJect II - 5 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 6 months not refrigerated stored at or below 25°C protect from light 3 hours reconstituted (not refrigerated) stored at or below 25°C protect from light - Vial, glass, Diluent. Chloro- or bromo-butyl stopper - 5 mL -   - Vial, glass, active - 3000 IU -  

Authorization date:

2007-07-27

Patient Information leaflet

ADVATE
®
_(WITH BAXJECT II)_
_Octocog alfa_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
YOU START USING ADVATE.
This leaflet answers some common
questions about ADVATE.
It does not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using ADVATE
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may wish to read it again.
Information in this leaflet is subject
to change over time.
Ask your doctor or visit the Health
Authority website (in Australia:
www.ebs.tga.gov.au; in New
Zealand: www.medsafe.govt.nz) for
the latest Consumer Medicine
Information.
WHAT IS ADVATE USED
FOR
ADVATE belongs to the group of
medicines called blood coagulation
factor VIII.
It is used for the treatment and
prophylaxis of bleeding in patients
with haemophilia A (congenital
factor VIII deficiency).
ADVATE does not contain von
Willebrand factor and is therefore not
suitable for use in von Willebrand's
disease.
ADVATE contains the active
ingredient octocog alfa, which is a
human recombinant coagulation
factor VIII produced by recombinant
DNA technology.
_HOW DOES ADVATE WORK_
Under normal physiological
condition, factor VIII is essential for
blood clotting and maintenance of a
bleeding episode.
Individuals with haemophilia A
disease, which is a hereditary
disorder of blood coagulation have a
low level of factor VIII in their blood
circulation. As a result of factor VIII
deficiency, the individual with this
disease may have a heavy bleeding
into joints, muscles or internal organs
either spontaneously or as a result of
accidental or surgical trauma.
ADVATE is similar to and works in
the same way as plasma-derived
factor VIII. As such, it can be used as
a replacement therapy to correct the
factor VIII deficiency in patients
with haemophilia A.
BEFORE YOU

Summary of Product characteristics

NEW ZEALAND DATA SHEET
ADVATE Data Sheet V1.0 CCDS 7.0
Page 1
1 PRODUCT NAME
ADVATE 250 IU powder for injection with diluent
ADVATE 500 IU powder for injection with diluent
ADVATE 1000 IU powder for injection with diluent
ADVATE 1500 IU powder for injection with diluent
ADVATE 2000 IU powder for injection with diluent
ADVATE 3000 IU powder for injection with diluent
ADVATE 4000 IU powder for injection with diluent
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Octacog alfa.
_Laboratory code_
rAHF-PFM
ADVATE contains nominally 250, 500, 1000, 1500, 2000, 3000 or 4000 IU
octocog alfa [recombinant
coagulation factor VIII (rFVIII)]. The product contains approximately
40 to 960 IU per mL octocog alfa
when reconstituted with either 5 mL or 2 mL sterile water for
injections.
ADVATE is available in the following strengths with 5 mL diluent of
water for injections:
250, 500, 1000, 1500, 2000, 3000 or 4000 IU.
ADVATE is available in the following strengths with 2 mL diluent of
water for injections:
250, 500, 1000, 1500 IU.
Each ADVATE vial is labelled with the strength expressed in IU
(International Units) per vial.
_Biological origin of the active substance _
Octocog alfa (rAHF-PFM / Recombinant Antihaemophilic Factor VIII
Plasma/Albumin-Free Method) is
produced from a genetically engineered Chinese Hamster Ovary (CHO)
cell-line under conditions
which are free from the use of animal derived protein.
Trehalose, a disaccharide of two glucose molecules linked by an α,
α, glucopyranose of glycoside bond
has been used as a stabiliser in the formulation, instead of human
albumin. The active ingredient,
octocog alfa, has been manufactured by a method that is free from the
use of animal or human
derived proteins. This manufacturing process provides a low risk of
transmission of blood-borne
viruses derived from exogenous human and animal origins.
The molecular integrity and biological activity of rAHF-PFM is
indistinguishable from that of the first
generation of rAHF. They differ on the culture media used during the
manufacturing pr