Prothromplex TOTAL 500 IU powder and solvent for solution for injection

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Baxalta Innovations GmbH Industriestrasse 67, 1221, Vienna, Austria

ATC code:

B02BD01

INN (International Name):

HUMAN COAGULATION FACTOR X 30 IU/ml HUMAN COAGULATION FACTOR IX 30 IU/ml HUMAN COAGULATION FACTOR VII 25 IU/ml HUMAN COAGULATION FACTOR II 22.5-42.5 IU/ml

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composition:

HUMAN COAGULATION FACTOR X 30 IU/ml HUMAN COAGULATION FACTOR IX 30 IU/ml HUMAN COAGULATION FACTOR VII 25 IU/ml HUMAN COAGULATION FACTOR II 22.5-42.5 IU/ml

Prescription type:

POM

Therapeutic area:

ANTIHEMORRHAGICS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2023-05-23

Patient Information leaflet

Page 1 of 14
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROTHROMPLEX TOTAL 500 IU
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Human Prothrombin Complex
READ ALL OF THIS LEAFLET CAREFULLY BEFORE ADMINISTRATION OF THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Prothromplex TOTAL is and what it is used for
2.
What you need to know before you use Prothromplex TOTAL
3.
How to use Prothromplex TOTAL
4.
Possible side effects
5.
How to store Prothromplex TOTAL
6.
Contents of the pack and other information
1.
WHAT PROTHROMPLEX TOTAL IS AND WHAT IT IS USED FOR
Prothromplex TOTAL is a preparation made from human plasma (the liquid
part of blood). It
contains the blood clotting factors II, VII, IX and X (prothrombin
complex coagulation factors), as
well as protein C.
These clotting factors are vitamin K-dependent and, like vitamin K,
they play an important role in
blood clotting. In the event of a deficiency of one of these factors,
blood does not clot as rapidly as
usual, which leads to an increased bleeding tendency.
Prothromplex TOTAL is used for:
•
the treatment of bleeding
•
the prevention of bleeding immediately before or after surgery
•
the conditions acquired deficiency and congenital deficiency of
coagulation factors
_Acquired deficiency: _
You may develop a deficiency of the vitamin K-dependent coagulation
factors (acquired
deficiency), for example, from treatment with or an overdose of
medicinal products that reduce the
effect of vitamin K (so-called vitamin K antagonists).
_Congenital deficiency:_
If you were born with a deficiency (congenital deficiency), this
medicine may be given to you
immediately before or after surgery if the appropriate individual
factor concentrat

Summary of Product characteristics

Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Prothromplex TOTAL 500 IU powder and solvent for solution for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: human prothrombin complex
Prothromplex TOTAL 500 IU is a powder for solution for intravenous
application. Each vial
nominally contains the following IU of human coagulation factors.
PER VIAL
[IU]
AFTER RECONSTITUTION IN 17 ML STERILIZED
WATER FOR INJECTIONS
[IU/ML]
Human coagulation factor II
375 – 708
22.5 – 42.5
Human coagulation
factor VII
417
25
Human coagulation factor IX
500
30
Human coagulation factor X
500
30
The total protein content per vial is 250 – 625 mg. The specific
activity of the product is at least
0.6 IU/mg, in relation to the factor IX activity.
One vial contains at least 333 IU protein C co-purified with the blood
coagulation factors.
The activity (IU) of factor IX was determined by the one-step
coagulation test described in the
European Pharmacopoeia, which is calibrated against the International
Standard for Factor IX
Concentrates of the World Health Organisation (WHO).
The activity (IU) of factor II, factor VII and factor X was determined
by the chromogenic assay
described in the European Pharmacopoeia, which is calibrated against
the International Standards
for Factor II, Factor VII and Factor X Concentrates of the World
Health Organisation (WHO).
The activity (IU) of protein C was determined by the chromogenic assay
described in the European
Pharmacopoeia, which is calibrated against the International Standard
for protein C Concentrates of
the World Health Organisation (WHO).
Excipients with known effect
Prothromplex TOTAL 500 IU contains 68 mg sodium per vial. Furthermore,
each vial contains
heparin sodium (max. 0.5 IU/IU factor IX).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Powder: White to light yellow, freeze dried powdery or compact dry
substance.
Page 2 of 14
Solvent: Sterilized water for