MonoFIX-VF

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Factor IX 500 [iU] (Human Coagulation 100IU/mL when reconstituted with 5mL water for injections)

Tilgjengelig fra:

CSL Behring (NZ) Ltd

INN (International Name):

Factor IX 500 IU (Human Coagulation 100IU/mL when reconstituted with 5mL water for injections)

Dosering :

500 IU

Legemiddelform:

Injection with diluent

Sammensetning:

Active: Factor IX 500 [iU] (Human Coagulation 100IU/mL when reconstituted with 5mL water for injections) Excipient: Antithrombin III Chloride Citric acid monohydrate Heparin Phosphorus Plasma protein fraction Sodium Water for injection

Enheter i pakken:

Combination pack, Vial + diluent, 500 IU

Klasse:

General sale

Resept typen:

General sale

Produsert av:

CSL Behring (Australia) Pty Ltd

Indikasjoner:

MonoFIX®-VF is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia B. MonoFIX®-VF is not indicated for the treatment of factor II, VII or X deficiencies because it does not contain therapeutic levels of these coagulation factors. MonoFIX®-VF is not indicated for the treatment of haemophilia A patients with factor VIII inhibitors.

Produkt oppsummering:

Package - Contents - Shelf Life: Combination pack, Vial + diluent - 500 IU - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, diluent - 5 mL - 0 months Not applicable - Vial, glass, lypholiised powder - 500 IU - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Autorisasjon dato:

2004-07-12

Informasjon til brukeren

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INFORMATION FOR
CONSUMERS
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Consumer Medicine
Information
MonoFIX
®
-VF
Human coagulation factor IX, freeze-dried.
What is in this leaflet
This leaflet answers some common questions about MonoFIX
®
-VF. It does not contain complete
information about MonoFIX
®
-VF. It does not take the place of talking to your doctor. If you have any
concerns about using this product, please talk to your doctor. Follow your doctor's advice, even if it is
different from what this leaflet says.
Please read this leaflet carefully and keep it for future reference. However, the information in this leaflet
is subject to change. Please check with your haemophilia treatment centre if there is any new
information about this medicine that you should know since you were last treated with this medicine.
What MonoFIX
®
-VF is used for
MonoFIX
®
-VF contains purified and concentrated factor IX, a protein which is essential for normal
blood clotting. MonoFIX
®
-VF is used in patients with haemophilia B or Christmas disease, a bleeding
disorder, in which there are reduced levels of the clotting factor. Also, it is available for use in surgery.
Individuals with factor IX levels lower than normal have difficulty in forming blood clots, with these
clots often taking longer to be made than normal. Sometimes the individual may bleed unexpectedly into
their joints, muscles or internal organs.
Ask your haemophilia treatment centre if you have any questions about why MonoFIX
®
-VF has been
prescribed for you.
Before your doctor gives you MonoFIX
®
-VF
SPECIAL WARNING
This product is made from human blood. When products are made from human blood and injected into
This product is made from

Preparatomtale

NEW ZEALAND DATA SHEET
MonoFIX®-VF NZ DS 5.00
Page 1 of 13
1 PRODUCT NAME
MonoFIX
®
-VF 500 IU powder and diluent (10 mL) for solution for injection
MonoFIX
®
-VF 500 IU powder and diluent (5 mL) for solution for injection
MonoFIX
®
-VF 1000 IU powder and diluent (10 mL) for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
MonoFIX
®
-VF is a sterile freeze-dried powder containing purified human
coagulation factor IX.
MonoFIX
®
-VF is manufactured from human plasma donated by New Zealand’s
voluntary and
non-remunerated donors. The factor IX in MonoFIX
®
-VF is purified using ion-exchange and
heparin affinity chromatography to remove other vitamin K-dependent
factors such as factors II, VII
and X.
MonoFIX
®
-VF is presented in two different concentrations (strengths): 50 IU/mL
and 100 IU/mL,
and in three different presentations as detailed in
TABLE 1
.
TABLE 1: MONOFIX
®
-VF PRESENTATIONS
PRESENTATION
500 IU
(50 IU
FACTOR IX/ML)
500 IU
(100 IU
FACTOR IX/ML)
1000 IU
(100 IU
FACTOR IX/ML)
ACTIVE INGREDIENT IU/VIAL (NOMINAL)
Factor IX
500
500
1000
RECONSTITUTION VOLUME (ML)
10
5
10
CONCENTRATION
50 IU/ML
100 IU/ML
100 IU/ML
PLASMA PROTEINS (MG/ML)
≤ 2
≤ 4
≤ 4
Not all registered presentations may be supplied.
EXCIPIENTS WITH KNOWN EFFECT
MonoFIX
®
-VF contains 28 mg (1.2 mmol) sodium in each 500 IU vial and 56 mg
(2.4 mmol) sodium
in each 1000 IU vial.
MonoFIX
®
-VF contains 50–140 IU heparin in each 500 IU vial and 100–280 IU
heparin in each
1000 IU vial.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and diluent for solution for injection
Powder: white
Diluent (Water for Injections): clear, colourless.
NEW ZEALAND DATA SHEET
MonoFIX®-VF NZ DS 5.00
Page 2 of 13
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MonoFIX
®
-VF is indicated for the treatment of haemorrhages, for use in
surgery, and as prophylaxis
in patients with haemophilia B. MonoFIX
®
-VF is not indicated for the treatment of factor II, VII or
X deficiencies because it does not