Cluvot 250 IU, powder and solvent for solution for injection/infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HUMAN COAGULATION, FACTOR XIII

Available from:

CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Germany

ATC code:

B02BD07

INN (International Name):

HUMAN COAGULATION FACTOR XIII 250 IU

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INFUSION OR INJECTION

Composition:

HUMAN COAGULATION FACTOR XIII 250 IU

Prescription type:

POM

Therapeutic area:

ANTIHEMORRHAGICS

Authorization status:

Authorised

Authorization date:

2014-02-27

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CLUVOT 250 IU
Powder and solvent for solution for injection/infusion.
Human Plasma Coagulation Factor XIII concentrate
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 or pharmacist.
•
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 or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Cluvot is and what it is used for
2.
What you need to know before you are given Cluvot
3.
How to use Cluvot
4.
Possible side effects
5.
How to store Cluvot
6.
Contents of the pack and other information
1.
WHAT CLUVOT IS AND WHAT IT IS USED FOR
_WHAT IS CLUVOT? _
Cluvot is presented as white powder and solvent. The made up solution
should be given by
injection into a vein.
Cluvot is a human plasma coagulation factor XIII (FXIII) product (this
is the liquid part of the
blood), and has important functions in haemostasis (stopping
bleeding).
_WHAT IS CLUVOT USED FOR? _
Cluvot is used for aedult and paediatric patients
•
for preventative treatment of inherited factor XIII deficiency and
•
for peri-operative management of surgical bleeding with congenital
FXIII deficiency.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CLUVOT
The following sections contain information that your doctor should
consider before you are
given Cluvot.
DO NOT USE CLUVOT:
•
if you are allergic to the active substances or any other ingredients
of this medicine (listed
in section 6).
PLEASE INFORM YOUR DOCTOR IF YOU ARE ALLERGIC TO ANY MEDICINE OR FOOD.
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WARNINGS AND PRECAUTIONS
•
if you have experienced allergic reactions on coagulation FXIII in the
past. You should
take antihistamines

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cluvot 250 IU, powder and solvent for solution for injection/infusion.
Cluvot 1250 IU, powder and solvent for solution for
injection/infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
: Cluvot is a purified concentrate of human plasma coagulation factor
XIII
(FXIII). It is presented as a white powder.
Each vial contains nominally 250 or 1250 IU human plasma coagulation
factor XIII.
Cluvot contains approximately 62.5 IU/ml (250 IU/4 ml and 1250 IU/20
ml) of human plasma
coagulation factor XIII when reconstituted with 4 and 20 ml water for
injection, respectively.
The specific activity of Cluvot is approximately 6 – 10 IU/mg
protein.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection/ infusion.
White powder and clear, colourless solvent.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cluvot is indicated for adult and paediatric patients
•
for prophylactic treatment of congenital FXIII deficiency and
•
for peri-operative management of surgical bleeding with congenital
FXIII deficiency.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY _
1 ml is equivalent to approximately 62.5 IU, and 100 IU are equivalent
to 1.6 ml, respectively.
Important:
The amount to be administered and the frequency of administration
should always be oriented
towards the clinical efficacy in the individual case.
_DOSAGE _
The dosing regimen should be individualized based on body weight,
laboratory values, and
the patient’s clinical condition.
Routine Prophylaxis Dosing Schedule
Initial dose
•
40 International Units (IU) per kg body weight
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The injection rate should not exceed 4 ml per minute.
Subsequent dosing
•
Dosing should be guided by the most recent trough FXIII activity
level, with dosing every
28 days (4 weeks) to maintain a trough FXIII activity level of
approximately 5 to 20%.
•
Recommended dosing adjustments of ±5 IU per kg should