ADVATE octocog alfa (rch) 1500 IU powder for injection vial with diluent vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Octocog alfa, Quantity: 1500 IU

Available from:

Takeda Pharmaceuticals Australia Pty Ltd

INN (International Name):

Octocog alfa

Pharmaceutical form:

Diluent, not applicable

Composition:

Excipient Ingredients: water for injections

Administration route:

Intravenous

Units in package:

1 vial with advate (octocog alfa (rch)) 1500 IU powder and 1 vial of diluent (WFI) with a drug delivery system (Baxject II or Baxject III)

Prescription type:

exempt from scheduling - Appendix A; prescription medicine

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:

Visual Identification: clear colourless liquid with no particulate matter; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2005-04-04

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

ADVATE PI V1.0 7OCT2020 (CCDS 7.0)
1 of 21
AUSTRALIAN PRODUCT INFORMATION
ADVATE
® (OCTOCOG ALFA)
1
NAME OF THE MEDICINE
Octocog alfa.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ADVATE 250, 500, 1000, 1500, 2000, 3000, 4000 International Units
(IU).
ADVATE contains nominally 250, 500, 1000, 1500, 2000, 3000 or 4000 IU
octocog alfa
[recombinant coagulation factor VIII (recombinant FVIII)]. 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 per
vial.
Octocog alfa, recombinant antihaemophilic factor VIII
Plasma/Albumin-Free Method
(rAHF-PFM), 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
process and the cell lines. In the first generation of rAHF
production, the cell lines are grown in
a culture medium containing animal/human derived proteins, whereas in
the rAHF-PFM
production, the cell lines are adapted to grow without using
animal/human components. The
CHO cells transfected with factor VI