FEIBA NF

Land: Neuseeland

Sprache: Englisch

Quelle: Medsafe (Medicines Safety Authority)

Wirkstoff:

Factor VIII inhibitor bypassing fraction 1000 U;  ;  

Verfügbar ab:

Takeda New Zealand Limited

INN (Internationale Bezeichnung):

Factor VIII inhibitor bypassing fraction 1000 U

Dosierung:

1000 U

Darreichungsform:

Powder for injection with diluent

Zusammensetzung:

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

Einheiten im Paket:

Combination pack, FEIBA + diluent, 20 mL

Klasse:

General sale

Verschreibungstyp:

General sale

Hergestellt von:

Baxter Manufacturing SpA

Anwendungsgebiete:

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.

Produktbesonderheiten:

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

Berechtigungsdatum:

2000-12-08

Gebrauchsinformation

FEIBA NF
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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 FEIBA NF?
FEIBA NF contains the active ingredient factor VIII inhibitor
bypassing fraction. FEIBA NF is used to treat and prevent bleeding
in patients with haemophilia A and B who have developed inhibitors
(antibodies) against coagulation factor VIII and factor IX,
respectively. For more information, see Section 1. Why am I using
FEIBA NF? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE FEIBA NF?
Do not use if you are allergic to FEIBA NF or any of the ingredients
listed at the end of the CMI. Do not use if you are suffering from
a blood clotting condition called Disseminated Intravascular
Coagulation. Talk to your doctor if you have or have had any other
medical conditions, if you take any other medicines, if you are
pregnant or plan to become pregnant or if you are breastfeeding or
plan to breastfeed. If you are taking a medicine called emicizumab, it
is very important you talk to your doctor before using FEIBA
NF. For more information, see Section 2. What should I know before I
use FEIBA NF? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with FEIBA NF and how it works. Tell your
doctor or Haemophilia Treatment Centre if you are taking
or using any other medicines including any that you get without a
prescription from your pharmacy, supermarket, or health food
shop. For more information, see Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW WILL I BE GIVEN FEIBA NF?
•
FEIBA NF injection is prepared and administered by a qualified
healthcare professional who is experienced in the care of
patients with haemophilia.
•
Your dose of FEIBA NF is dependent on your condition and body weight,
and your dose may change during treatment.
•
The frequency of your infusions will depend on how well FEIBA NF is
working for you.
•
F

Fachinformation

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