OBIZUR susoctocog alfa (bhk) 500U antihemophilic factor (recombinant), porcine sequence powder for injection vial with water for injection syringe

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

susoctocog alfa, Quantity: 500 U/mL

Disponible desde:

Takeda Pharmaceuticals Australia Pty Ltd

Designación común internacional (DCI):

susoctocog alfa

formulario farmacéutico:

Injection

Composición:

Excipient Ingredients:

Vía de administración:

Intravenous

Unidades en paquete:

1, 10, 5

tipo de receta:

Not scheduled. Not considered by committee

indicaciones terapéuticas:

for the treatment of bleeding episodes in adults with acquired haemophilia A.,Safety and efficacy of OBIZUR have not been established in patients with baseline anti- porcine factor VIII inhibitor titre greater than 20 BU.,OBIZUR is not indicated for the treatment of congenital haemophilia A or von Willebrand disease.

Resumen del producto:

Visual Identification: Clear and colourless solution, practically free from visible particles; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estado de Autorización:

Licence status A

Fecha de autorización:

2016-04-29

Información para el usuario

OBIZUR
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING OBIZUR?
OBIZUR contains the active ingredient susoctocog alfa. OBIZUR is used
to treat bleeding episodes in adults with acquired
haemophilia A (a bleeding disorder caused by lack of Factor VIII
activity due to antibody development against Factor VIII).
For more information, see Section 1. Why am I using OBIZUR? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE OBIZUR?
Do not use if you have ever had an allergic reaction to OBIZUR, or you
are allergic to hamster proteins or any of the ingredients
listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
OBIZUR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
There are no known interactions of OBIZUR with other medicines.
For more information, see Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW WILL I BE GIVEN OBIZUR?
•
OBIZUR injection will be prepared and administered by a qualified
healthcare professional who is experienced in the care of
patients with haemophilia.
•
Your doctor will calculate your dose of OBIZUR depending on your
condition and body weight.
•
OBIZUR is given slowly by injection directly into your vein.
•
The frequency of infusions you receive, and the duration of treatment,
will depend on how well OBIZUR is working for you.
More instructions can be found in Section 4. How do I use OBIZUR? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING OBIZUR?
THINGS YOU
SHOULD DO
•
Tell your doctor or healthcare professional straight away if you
notice:
•
any sudden signs and symptoms of a severe allergic response, e.g.
shortness of breath, wheezing,
difficulty breathing; chest pain or discomfort; light heade

Ficha técnica

OBIZUR PI V3.0 CCDS 5.1
Page
1
AUSTRALIAN PRODUCT INFORMATION
OBIZUR
® (SUSOCTOCOG ALFA)
1
NAME OF THE MEDICINE
Susoctocog alfa (bhk).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each OBIZUR vial contains nominally 500 units (U) of susoctocog alfa,
which is a B domain
deleted recombinant derived antihaemophilic factor VIII (rpFVIII),
porcine sequence.
After reconstitution, OBIZUR contains nominally 500 U/mL susoctocog
alfa.
Each vial of OBIZUR is labelled with the actual rpFVIII activity
expressed in units determined
by a one-stage clotting assay, using a reference rpFVIII material
calibrated against the World
Health Organization (WHO) 8th International Standard for human factor
VIII concentrates.
The specific activity of OBIZUR is in the range of 11000 - 18000 Units
per milligram of
protein. The potency values of OBIZUR determined by the chromogenic
assay vary and are
approximately 20-50 % lower than those of the one-stage clotting
assay.
Susoctocog alfa is expressed in a genetically engineered baby hamster
kidney (BHK) cell line
and secreted into the cell culture medium, and the protein is purified
using a series of
chromatography and filtration steps. The production process includes
two dedicated viral
clearance steps - a solvent/detergent treatment step for viral
inactivation and a nanofiltration
step through a series of two 15-nm filters for removal of viruses. No
additives of human or
animal origin are used in the formulation of OBIZUR.
Excipient(s) with known effect
Each vial of OBIZUR contains maximally 4.4 mg (198 mM) sodium per mL
of reconstituted
solution (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Powder and diluent for solution for injection
OBIZUR is formulated as a white, sterile, non-pyrogenic, lyophilised
powder for intravenous
injection after reconstitution with the diluent.
The diluent, water for injections, is a clear and colourless solution,
practically free from visible
particles.
OBIZU