Prothromplex TOTAL 500 IU powder and solvent for solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Human coagulation factor ii; Human coagulation factor vii; Human coagulation factor ix; Human coagulation factor x; Human Protein C

Available from:

Baxalta Innovations GmbH

ATC code:

B02BD01

INN (International Name):

Human coagulation factor ii; Human coagulation factor vii; Human coagulation factor ix; Human coagulation factor x; Human Protein C

Pharmaceutical form:

Powder and solvent for solution for injection

Therapeutic area:

coagulation factor IX, II, VII and X in combination

Authorization status:

Not marketed

Authorization date:

2023-06-09

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 concentrate is not available.
2
2.

Summary of Product characteristics

Health Products Regulatory Authority
13 June 2023
CRN00CW39
Page 1 of 13
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