FEIBA NF

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Factor VIII inhibitor bypassing fraction 1000 U;  ;  

Available from:

Takeda New Zealand Limited

INN (International Name):

Factor VIII inhibitor bypassing fraction 1000 U

Dosage:

1000 U

Pharmaceutical form:

Powder for injection with diluent

Composition:

Active: Factor VIII inhibitor bypassing fraction 1000 U     Excipient: Sodium chloride Sodium citrate dihydrate Water for injection

Units in package:

Combination pack, FEIBA + diluent, 20 mL

Class:

General sale

Prescription type:

General sale

Manufactured by:

Baxter Manufacturing SpA

Therapeutic indications:

FEIBA NF is indicated for treatment of haemorrhage and to cover surgical interventions in: · Haemophilia A patients with Factor VIII inhibitors · Haemophilia B patients with Factor IX inhibitors. FEIBA NF is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in haemophilia A subjects with inhibitors experiencing >/= 12 bleeding episodes per year. Prophylaxis with FEIBA NF is recommended for patients with high titer (>5BU) inhibitor or low titer (<5 BU) inhibitor, refractory to increased dosing with FVIII or FIX.

Product summary:

Package - Contents - Shelf Life: Combination pack, FEIBA + diluent - 20 mL - 24 months from date of manufacture stored at or below 25°C protect from light. do not freeze 3 hours reconstituted stored at or below 25°C - Vial, glass, diluent - WFI - 20 mL - 48 months from date of manufacture stored at or below 25°C. do not freeze - Vial, glass, FEIBA - 1000 U - 24 months from date of manufacture stored at or below 25°C protect from light. do not freeze 3 hours reconstituted stored at or below 25°C

Authorization date:

2000-12-08

Patient Information leaflet

FEIBA-NF V2.0
1
FEIBA
® NF
_Factor VIII inhibitor bypassing fraction powder for injection with
diluent vials (500, 1000, 2500 U/vial) _
NEW ZEALAND 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
of bleeding in haemophilia A and B
patients who have developed
inhibitors (antibodies) against
coagulation factor VIII (FVIII), and
factor IX (FIX) respectively.
FEIBA NF may also be used for
treating non-haemophiliacs with
acquired inhibitors to factors VIII, XI
and XII in case of severe or life
threatening haemorrhages.
FEIBA NF is also used to prevent or
reduce the frequency of bleeding
episodes in haemophilia A patients
who have developed inhibitors and
who experience 12 or more bleeding
episodes per year.
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 beco

Summary of Product characteristics

NEW ZEALAND DATA SHEET
FEIBA NF Data Sheet V3.0 CCDSv3
Page 1
1 PRODUCT NAME
FEIBA NF 500 U injection with diluent
FEIBA NF 1000 U injection with diluent
FEIBA NF 2500 U injection with diluent
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Factor VIII inhibitor bypassing fraction 500 U, 1000 U and 2500 U.
FEIBA NF contains a complex of coagulation factors. The potency of
FEIBA NF is expressed in arbitrary
units of factor FVIII 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 (FVIII) inhibitor
reference plasma to 50% of the blank value.
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).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Injection with diluent.
FEIBA NF is formulated as a sterile, nonpyrogenic, off-white,
lyophilised powder, for intravenous
injection after reconstitution with the water for injection diluent
provided.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
On-demand and surgery indication
FEIBA NF is indicated for treatment of haemorrhage and to cover
surgical interventions in:
•
Haemophilia A patients with FVIII inhibitor
•
Haemophilia B patients with FIX inhibitor
FEIBA NF was also used in combination with Factor VIII concentrate for
a continual long term therapy
to achieve a complete and permanent elimination of the FVIII inhibitor
so as to allow for regular
treatment with FVIII concentrate as in patients without inhibitor.
In addition, FEIBA NF may be used for treating non-haemophiliacs with
acquired inhi