NovoThirteen
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
21-03-2022
Fachinformation
(SPC)
21-03-2022
Öffentlichen Beurteilungsberichts
(PAR)
26-11-2020
Wirkstoff:
catridecacog
Verfügbar ab:
Novo Nordisk A/S
ATC-Code:
B02BD11
INN (Internationale Bezeichnung):
catridecacog
Therapiegruppe:
Antihemorrhagics
Therapiebereich:
Blood Coagulation Disorders, Inherited
Anwendungsgebiete:
Long-term prophylactic treatment of bleeding in adult and paediatric patients 6 years and above with congenital factor-XIII-A-subunit deficiency.
Produktbesonderheiten:
Revision: 7
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2012-09-03
Gebrauchsinformation
22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE USER
NOVOTHIRTEEN 2500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
catridecacog (recombinant coagulation factor XIII)
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. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What NovoThirteen is and what it is used for
2.
What you need to know before you use NovoThirteen
3.
How to use NovoThirteen
4.
Possible side effects
5.
How to store NovoThirteen
6.
Contents of the pack and other information.
1.
WHAT NOVOTHIRTEEN IS AND WHAT IT IS USED FOR
WHAT NOVOTHIRTEEN IS
NovoThirteen contains the active substance catridecacog, which is
identical to human coagulation
factor XIII, an enzyme necessary for blood clotting. NovoThirteen
replaces the missing factor XIII and
helps to stabilise the initial blood clot by producing a mesh around
the clot.
WHAT NOVOTHIRTEEN IS USED FOR
NovoThirteen is
used to prevent bleeding in patients who do not have enough or are
missing part of
factor XIII (that is called A-subunit).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NOVOTHIRTEEN
It is important that you use NovoThirteen for injection immediately
after preparation.
DO NOT USE NOVOTHIRTEEN
•
If you are allergic to catridecacog or any of the other ingredients of
this medicine (listed in
section 6).
If you are not sure, ask your doctor before using this medicine.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using NovoThirteen:
•
If you have or have ever had a higher risk of blood clots forming
(thrombosis), as NovoThirteen
may increase the severity of a pre-existing blood clot.
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
NovoThirteen 2500 IU powder and solvent for solution for injection
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains catridecacog (recombinant coagulation factor XIII)
(rDNA): 2500 IU per 3 ml, after
reconstitution corresponding to a concentration of 833 IU/ml. The
specific activity of NovoThirteen is
approximately 165 IU/mg protein.
The active substance is produced in yeast cells (
_Saccharomyces cerevisiae_
) by recombinant DNA
technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is white and the solvent is clear and colourless.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Long term prophylaxis of bleeding in patients with congenital factor
XIII A-subunit deficiency.
Treatment of breakthrough bleeding episodes during regular
prophylaxis.
NovoThirteen can be used for all age groups.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a doctor
experienced in the treatment of rare
bleeding disorders. The congenital factor XIII A-subunit deficiency
should be confirmed by
appropriate diagnostic procedures including factor XIII activity and
immunoassay and if applicable
genotyping.
Posology
The potency of this medicinal product is expressed in international
units (IU).
Although expressed in the same unit (IU), the posology of NovoThirteen
is different from the dosing
schedule of the other FXIII containing products (see section 4.4).
_Prophylaxis _
The recommended dose for prophylactic treatment is 35 IU/kg body
weight once monthly (every
28 days ± 2 days), administered as an intravenous bolus injection.
_Treatment of bleeds _
If a breakthrough bleed occurs during regular prophylaxis, it is
recommended to treat with a single
dose of 35 IU/kg body weight administered as an intravenous bolus
injection.
If bleeds occur in a patient who is not on regular prophylaxis, a
single dose of 35
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