Coagadex

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Human coagulation factor X

Saatavilla:

BPL Bioproducts Laboratory GmbH

ATC-koodi:

B02BD13

INN (Kansainvälinen yleisnimi):

human coagulation factor X

Terapeuttinen ryhmä:

Vitamin K and other hemostatics, Antihemorrhagics, coagulation factor X

Terapeuttinen alue:

Factor X Deficiency

Käyttöaiheet:

Coagadex is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency. Coagadex is indicated in all age groups.

Tuoteyhteenveto:

Revision: 9

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2016-03-16

Pakkausseloste

27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COAGADEX 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
COAGADEX 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
human coagulation factor X
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Coagadex is and what it is used for
2.
What you need to know before you use Coagadex
3.
How to use Coagadex
4.
Possible side effects
5.
How to store Coagadex
6.
Contents of the pack and other information
1.
WHAT COAGADEX IS AND WHAT IT IS USED FOR
Coagadex is a concentrate of human coagulation factor X, a protein
that is needed for blood to clot. The
factor X in Coagadex is extracted from human plasma (the liquid part
of blood). It is used to treat and
prevent bleeding in patients with hereditary factor X deficiency,
including during surgery.
Patients with factor X deficiency do not have sufficient factor X for
their blood to clot properly, leading to
excessive bleeding. Coagadex replaces the missing factor X and allows
their blood to clot normally.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE COAGADEX
_ _
DO NOT USE COAGADEX:
-
if you are allergic to human coagulation factor X or any of the other
ingredients of this medicine
(listed in section 6).
Check with your doctor if you think this applies to you.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Coagadex:
-
if you have a larger or longer bleed than usual and the bleeding does
not stop after an injection of
Coagadex.
-
if you are taking a medicine to prevent

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Coagadex 250 IU powder and solvent for solution for injection
Coagadex 500 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Coagadex 250 IU powder and solvent for solution for injection
Each vial contains nominally 250 IU human coagulation factor X.
Coagadex contains approximately 100 IU/mL human coagulation factor X
after reconstitution with 2.5 mL
sterilised water for injections.
Coagadex 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU human coagulation factor X.
Coagadex contains approximately 100 IU/mL human coagulation factor X
after reconstitution with 5 mL
sterilised water for injections.
Produced from the plasma of human donors.
Excipients with known effect:
Coagadex contains up to 0.4 mmol/mL (9.2 mg/mL) of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Powder vial containing white or off-white powder.
Solvent vial containing clear colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Coagadex is indicated for the treatment and prophylaxis of bleeding
episodes and for perioperative
management in patients with hereditary factor X deficiency.
Coagadex is indicated in all age groups
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
experienced in the treatment of rare
bleeding disorders.
Posology
The dose and duration of the treatment depend on the severity of the
factor X deficiency (i.e. the patient’s
baseline factor X level), on the location and extent of the bleeding
and on the patient’s clinical condition.
Careful control of replacement therapy is especially important in
cases of major surgery or life-threatening
bleeding episodes.
Not more than 60 IU/kg daily should be administered in any age group.
3
In adults and adolescents at least 12 years of age, the expected
_in vivo_
peak i