Afstyla

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

lonoctocog alfa

Διαθέσιμο από:

CSL Behring GmbH

Φαρμακολογική κατηγορία (ATC):

B02BD02

INN (Διεθνής Όνομα):

lonoctocog alfa

Θεραπευτική ομάδα:

Antihemorrhagics

Θεραπευτική περιοχή:

Hemophilia A

Θεραπευτικές ενδείξεις:

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).Afstyla can be used for all age groups.

Περίληψη προϊόντος:

Revision: 10

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2017-01-04

Φύλλο οδηγιών χρήσης

44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE USER
AFSTYLA 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
AFSTYLA 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
AFSTYLA 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
AFSTYLA 1500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
AFSTYLA 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
AFSTYLA 2500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
AFSTYLA 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
lonoctocog alfa (recombinant, single-chain coagulation factor VIII)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START
USING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, ask your doctor, pharmacist or nurse.
•
This medicine has been prescribed for you
OR YOUR CHILD
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 AFSTYLA is and what it is used for
2.
What you need to know before you
OR YOUR CHILD
use AFSTYLA
3.
How to use AFSTYLA
4.
Possible side effects
5.
How to store AFSTYLA
6.
Contents of the pack and other information
1.
WHAT AFSTYLA IS AND WHAT IT IS USED FOR
AFSTYLA is a human clotting (coagulation) factor VIII product that is
produced by recombinant
DNA technology. The active substance in AFSTYLA is lonoctocog alfa.
AFSTYLA is used to treat and prevent bleeding episodes in patients
with haemophilia A (inborn factor
VIII deficiency). Factor VIII is a protein needed for blood to clot.
Patients with haemophilia A lack
this factor, so blood does not clot as quickly as it should and they
have an increased tendency to bleed.
AFSTYLA works by replacing the missing factor VIII in haemophilia A
patients enabling their blood
to clot normally.
AFSTYLA can be

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
AFSTYLA 250 IU powder and solvent for solution for injection
AFSTYLA 500 IU powder and solvent for solution for injection
AFSTYLA 1000 IU powder and solvent for solution for injection
AFSTYLA 1500 IU powder and solvent for solution for injection
AFSTYLA 2000 IU powder and solvent for solution for injection
AFSTYLA 2500 IU powder and solvent for solution for injection
AFSTYLA 3000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AFSTYLA 250 IU powder and solvent for solution for injection
Each vial contains nominally 250 IU recombinant, single-chain
coagulation factor VIII
_ _
(rVIII-
SingleChain, INN = lonoctocog alfa). After reconstitution with 2.5 ml
water for injections the
solution contains 100 IU/ml of rVIII-SingleChain.
AFSTYLA 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU recombinant, single-chain
coagulation factor VIII
_ _
(rVIII-
SingleChain, INN = lonoctocog alfa). After reconstitution with 2.5 ml
water for injections the
solution contains 200 IU/ml of rVIII-SingleChain.
AFSTYLA 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU recombinant, single-chain
coagulation factor VIII
_ _
(rVIII-
SingleChain, INN = lonoctocog alfa). After reconstitution with 2.5 ml
water for injections the
solution contains 400 IU/ml of rVIII-SingleChain.
AFSTYLA 1500 IU powder and solvent for solution for injection
Each vial contains nominally 1500 IU recombinant, single-chain
coagulation factor VIII
_ _
(rVIII-
SingleChain, INN = lonoctocog alfa). When reconstituted with 5 ml
water for injections the
solution contains 300 IU/ml of rVIII-SingleChain.
AFSTYLA 2000 IU powder and solvent for solution for injection
Each vial contains nominally 2000 IU recombinant, single-chain
coagulation factor VIII
_ _
(rVIII-
SingleChain, INN = lonoctocog alfa). When reconstituted with 5 ml
water for injections the
solution contains 400 IU