MONOFIX-VF human coagulation factor IX 1000IU powder for injection vial and 10 mL diluent vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Factor IX, Quantity: 1000 IU

Available from:

CSL Behring Australia Pty Ltd

INN (International Name):

Factor IX

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: phosphate; Plasma proteins; Antithrombin III; heparin sodium; sodium; citrate; chloride

Administration route:

Intravenous

Units in package:

Glass vial containing 1000 IU factor IX supplied with 1 x 10 mL diluent vial

Prescription type:

Not scheduled. Not considered by committee

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 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.

Product summary:

Visual Identification: A white powder plug or friable solid; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2005-05-31

Patient Information leaflet

MonoFIX-VF AU CMI 3.00
Page 1 of 6
MONOFIX
®
-VF_ _
Human coagulation factor IX.
CONSUMER MEDICINE INFORMATION
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 MEDICINE,
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.
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.
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 YOU ARE GIVEN
MONOFIX
®
-VF
TELL YOUR DOCTOR IF YOU:
•
have allergies to any
medicines
•
are taking or using any
other medicines. These
include medicines bought
from pharmacies,
supermarkets and health
food stores.
•
have any other medical
conditions
•
are pregnant or
breast-feeding
•
become pregnant during
your treatment.
If you want further information,
consult your doctor or
haemophilia treatment centre.
ABOUT BLOOD PRODUCTS
MonoFIX
®
-VF is manufactured
from human plasma (the liquid
component of blood) collected
by Australian Red Cross
Lifeblood. W

Summary of Product characteristics

MonoFIX-VF AU PI 4.00
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION
MONOFIX
®
-VF
(HUMAN COAGULATION FACTOR IX)
1
NAME OF THE MEDICINE
Human coagulation factor IX.
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 collected by Australian Red
Cross Lifeblood. 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
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
(FACTOR IX)
50 IU/ML
100 IU/ML
100 IU/ML
Not all registered presentations may be supplied.
For the full list of excipients, see section 6.1: List of excipients.
3
PHARMACEUTICAL FORM
Powder and diluent for solution for injection
Powder: white
Diluent (Water for Injections): clear, colourless
MonoFIX-VF AU PI 4.00
Page 2 of 13
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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 contain
therapeutic levels of these
coagulation factors. MonoFIX
®
-VF is not indicated for the treatment of haemophilia A
patients with factor VIII inhibitors.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
The dosage recommendations in
TABLE 2
are a general guideline for therapy. The exact
loading and maintenance doses and dosing intervals should be based on
the patient
’
s clinical
condition and response to therapy. Laboratory tests should be
performed to