Prothromplex TOTAL 600 IU powder and solvent for solution for injection

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

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

Fáanlegur frá:

Baxalta Innovations GmbH

ATC númer:

B02BD; B02BD01

INN (Alþjóðlegt nafn):

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

Skammtar:

600 international unit(s)

Lyfjaform:

Powder and solvent for solution for injection

Stjórnsýsluleið:

intravenous route s

Einingar í pakka:

1 x 600 IU

Gerð lyfseðils:

Product subject to prescription which may not be renewed (A)

Meðferðarhópur:

antihemorrhagics, coagulation factors IX, II, VII and X in combination

Lækningarsvæði:

Blood coagulation factors; coagulation factor IX, II, VII and X in combination

Ábendingar:

Treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of prothrombin complex coagulation factors, such as a deficiency caused by treatment with vitamin K antagonists or in case of overdose with vitamin K antagonists, when rapid correction of the deficiency is required. Treatment and perioperative prophylaxis of hemorrhages in congenital deficiency of vitamin K-dependent coagulation factors, when purified specific coagulation factor concentrate is not available.

Leyfisstaða:

Marketed

Leyfisdagur:

2014-11-03

Upplýsingar fylgiseðill

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PROTHROMPLEX TOTAL 600 IU
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Active substance: 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.
-
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

Vara einkenni

Health Products Regulatory Authority
04 July 2022
CRN00D077
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prothromplex TOTAL 600 IU powder and solvent for solution for
injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: human prothrombin complex
Prothromplex TOTAL 600 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 20 ML STERILIZED WATER FOR INJECTIONS
IU/ML
Human coagulation factor II
450 - 480
22.5- 42.5
Human coagulation factor VII
500
25
Human coagulation factor IX
600
30
Human coagulation factor X
600
30
The total protein content per vial is 300 - 750 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 400 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 600 IU contains 81.7 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
subs