FEIBA-NF factor VIII inhibitor bypassing fraction 2500U powder for injection vial with diluent vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Factor VIII inhibitor bypassing fraction, Quantity: 1000 mg

Available from:

Takeda Pharmaceuticals Australia Pty Ltd

INN (International Name):

Factor VIII inhibitor bypassing fraction

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium citrate dihydrate; sodium chloride

Administration route:

Intravenous

Units in package:

2500 U + 50 mL sWFI vial

Prescription type:

exempt from scheduling - Appendix A; prescription medicine

Therapeutic indications:

FEIBA-NF is indicated for routine prophylaxis, control of spontaneous bleeding episodes and use in surgery in haemophilia A or B patients with inhibitors.

Product summary:

Visual Identification: white to off-white or pale green powder or friable mass, free from foreign particles; Container Type: Multiple containers; Container Material: Glass; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2012-03-30

Patient Information leaflet

FEIBA
® NF
_Factor VIII inhibitor bypassing fraction powder for injection with
diluent vials (500, 1000, 2500 U/vial)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
YOU START USING FEIBA NF.
This leaflet answers some common
questions about the FEIBA NF. 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 against the benefits of using
FEIBA NF for you.
IF YOU HAVE ANY CONCERNS ABOUT
HAVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
WHAT FEIBA NF IS
USED FOR
FEIBA NF is used for the treatment
and prevention of bleeding in
haemophilia A and B patients who
have developed inhibitors
(antibodies) against coagulation
factor VIII (FVIII), and factor IX
(FIX) respectively.
It is possible that your doctor may
give you FEIBA NF for another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY YOU ARE BEING
GIVEN FEIBA NF.
_HOW DOES FEIBA NF WORK_
Under normal physiological
conditions, FVIII and FIX are
essential for blood clotting and
therefore the control of bleeding.
Individuals with haemophilia A have
decreased FVIII in their blood
circulation, and individuals with
haemophilia B have decreased levels
of FIX. These deficiencies may lead
to heavy bleeding into joints, muscles
or internal organs, either
spontaneously or as a result of
accidental or surgical trauma.
Some haemophilia A and
haemophilia B patients develop
antibodies against FVIII and FIX,
respectively, in the course of their
treatment, leading to replacement
therapy becoming ineffective.
In patients with acquired haemophilia
(non-haemophiliacs), some of these
coagulation factors are not working
properly because the patient has
developed antibodies to his/her own
coagulation factors.
FVIII and FIX replacement therapy
have been successfully used for the
treatment of haemophilia A and
haemophilia B as well as non-
haemophiliacs. FEIBA

Summary of Product characteristics

FEIBA NF PI V1.0 CCSI20920180202
Page
1
AUSTRALIAN PRODUCT INFORMATION
FEIBA NF
® (FACTOR VIII INHIBITOR BYPASSING FRACTION)
1
NAME OF THE MEDICINE
Factor VIII inhibitor bypassing fraction
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DESCRIPTION
FEIBA NF is a sterile lyophilised powder containing a complex of
coagulation Factors. It is
intended for intravenous administration after reconstitution.
The potency of FEIBA NF is expressed in arbitrary units of factor VIII
bypassing activity.
One Unit of activity is defined as that amount of FEIBA NF that
shortens the activated partial
thromboplastin time (aPTT) of a high titre Factor VIII inhibitor
reference plasma to 50% of
the blank value.
FEIBA NF contains Factors II, IX and X, mainly non-activated, and
Factor VII mainly in the
activated form. In addition, 1-6 units of Factor VIII coagulation
antigen (FVIII C: Ag) per
mL are present.
FEIBA NF is prepared from pooled human plasma. During manufacture, the
product is
subjected to two dedicated viral inactivation steps – vapour heat
treatment and nanofiltration.
FEIBA NF is available in three strengths with each vial containing 500
U, 1000 U or 2500 U
of factor VIII bypassing activity as contained in human plasma
protein.
Following reconstitution with the diluent vial provided, the FEIBA
activity in each vial is:
50 FEIBA units/mL (2500 U/50 mL, 1000 U/20 mL and 500 U/10 mL) or
25 FEIBA units/mL (500 U/20 mL).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Powder and diluent for injection
APPEARANCE
FEIBA NF is formulated as a sterile, nonpyrogenic, off-white,
lyophilised powder, for
intravenous injection. It is supplied in single-dose glass vials.
Each FEIBA NF 500 U pack contains:
-
1 powder vial of 500 FEIBA-units as contained in 200-600 mg human
plasma protein
-
1 diluent vial of either 10 mL or 20 mL water for injections
-
1 BAXJECT II Hi-Flow – Needleless transfer device intended for
transferring and mixing
drugs contained in two vials into a syringe.
FEIBA NF PI V1.0