PROTHROMBINEX-VF human prothrombin complex powder for injection vial and diluent vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Factor IX, Quantity: 500 IU; Factor X, Quantity: 500 IU; Factor II, Quantity: 500 IU

Available from:

CSL Behring Australia Pty Ltd

INN (International Name):

Factor II,Factor IX,Factor X

Pharmaceutical form:

Injection, diluent for

Composition:

Excipient Ingredients: water for injections

Administration route:

Intravenous

Units in package:

Glass vial containing 500 IU factor II, 500 IU factor IX, 500 IU factor X supplied with 1 x 20 mL diluent vial.

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Prothrombinex-VF is indicated in - Treatment and perioperative prophylaxis of bleeding in acquired deficiency of prothrombin complex factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required. - Treatment and prophylaxis of bleeding in patients with single or multiple congenital deficiency of factor IX, II or X when purified specific coagulation factor product is not available (see PRECAUTIONS).

Product summary:

Visual Identification: clear and colourless liquid; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2006-01-30

Patient Information leaflet

Prothrombinex-VF AU CMI 14.00
Page 1 of 3
PROTHROMBINEX
®
-VF
Human prothrombin complex, powder and diluent for solution for
injection.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Prothrombinex
®
-VF. It does not
contain complete information
about Prothrombinex
®
-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 doctor if there is any
new information about this
medicine that you should know
since you were last treated.
WHAT
PROTHROMBINEX
®
-VF
IS USED FOR
Prothrombinex
®
-VF contains the
concentrated human coagulation
factors II, IX and X and low
levels of the factors V and VII.
These are proteins which are
essential for the normal blood
clotting process. The
coagulation factors II, VII, IX
and X which are synthesised in
the liver with the help of
vitamin K, are commonly called
the prothrombin complex.
Individuals with coagulation
factor levels lower than normal
exhibit signs of 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.
Prothrombinex
®
-VF is used in
patients who require reversal of
anticoagulant therapy and for
the prevention and treatment of
bleeding in patients with low
levels of factor II, IX or X. It is
not recommended for the
management of patients with
isolated factor V or factor VII
deficiency.
_ _
Ask your doctor if you have any
questions about why
Prothrombinex
®
-VF has been
prescribed for you.
BEFORE YOU ARE GIVEN
PROTHROMBINEX
®
-VF
Prothrombinex
®
-VF must not be
used if you:
•
are allergic to one of the
ingredients of this product
•
are allergic to heparin
•
have a h

Summary of Product characteristics

Prothrombinex-VF AU PI 14.00
Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION
PROTHROMBINEX
®
-VF
(HUMAN PROTHROMBIN COMPLEX)
POWDER AND DILUENT FOR SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Human prothrombin complex.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Prothrombinex
®
-VF is a sterile freeze-dried powder containing purified human
coagulation
factors II, IX and X and low levels of factors V and VII.
Prothrombinex
®
-VF is manufactured
from human plasma collected by Australian Red Cross Lifeblood.
The concentrate is prepared by adsorption of coagulation factors from
plasma onto an ion-
exchange medium followed by selective elution.
When reconstituted as recommended, each vial of Prothrombinex
®
-VF contains the active
ingredients listed in
TABLE 1
.
TABLE 1: PROTHROMBINEX
®
-VF ACTIVE INGREDIENT COMPOSITION
500 IU VIAL
ACTIVE INGREDIENTS
Factor IX
500 IU
Factor II
approx. 500 IU
Factor X
approx. 500 IU
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
Prothrombinex-VF AU PI 14.00
Page 2 of 18
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Prothrombinex
®
-VF is indicated in:
•
Treatment and perioperative prophylaxis of bleeding in acquired
deficiency of
prothrombin complex factors, such as deficiency caused by treatment
with vitamin K
antagonists, or in case of overdose of vitamin K antagonists, when
rapid correction of the
deficiency is required.
•
Treatment and prophylaxis of bleeding in patients with single or
multiple congenital
deficiency of factor IX, II or X when purified specific coagulation
factor product is not
available (see section 4.4: Special warnings and precautions for use).
4.2
D
OSE AND METHOD OF ADMINISTRATION
It is recommended that specialist guidelines are referred to when
administering
Prothrombinex
®
-VF. It is recommended that prescribed dosages of Prothrombinex
®
-VF are
expressed in International Units (written in ful