Vihuma
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
07-11-2022
Karatteristiċi tal-prodott
(SPC)
07-11-2022
Rapport ta 'Valutazzjoni Pubblika
(PAR)
15-01-2019
Ingredjent attiv:
simoctocog alfa
Disponibbli minn:
Octapharma AB
Kodiċi ATC:
B02BD02
INN (Isem Internazzjonali):
simoctocog alfa
Grupp terapewtiku:
Antihemorrhagics
Żona terapewtika:
Hemophilia A
Indikazzjonijiet terapewtiċi:
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).Vihuma can be used for all age groups.
Sommarju tal-prodott:
Revision: 8
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2017-02-13
Fuljett ta 'informazzjoni
43
B. PACKAGE LEAFLET
44
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIHUMA 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
VIHUMA 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
VIHUMA 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
VIHUMA 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
VIHUMA 2500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
VIHUMA 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
VIHUMA 4000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
simoctocog alfa (recombinant human coagulation factor VIII)
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 Vihuma is and what it is used for
2.
What you need to know before you use Vihuma
3.
How to use Vihuma
4.
Possible side effects
5.
How to store Vihuma
6.
Contents of the pack and other information
1.
WHAT VIHUMA IS AND WHAT IT IS USED FOR
Vihuma contains the active substance human recombinant coagulation
factor VIII (also called
simoctocog alfa). Factor VIII is necessary for the blood to form clots
and stop bleeding. In patients
with haemophilia A (inborn factor VIII deficiency), factor VIII is
missing or does not work properly.
Vihuma replaces the missing factor VIII so the blood can clot
normally, and can be used in all age
groups to treat and prevent bleeding in patients with haemophilia A.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VIHUMA
DO NOT USE VIHUMA
•
if you are allergic to the active substance simoctocog alfa or any of
the other ingredients of
this medicine (listed in section 6).
If you are unsure about this, ask your doctor.
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Vihuma 250 IU powder and solvent for solution for injection
Vihuma 500 IU powder and solvent for solution for injection
Vihuma 1000 IU powder and solvent for solution for injection
Vihuma 2000 IU powder and solvent for solution for injection
Vihuma 2500 IU powder and solvent for solution for injection
Vihuma 3000 IU powder and solvent for solution for injection
Vihuma 4000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vihuma 250 IU powder and solvent for solution for injection
Each vial contains nominally 250 IU human coagulation factor VIII
(rDNA), simoctocog alfa.
Vihuma 250 IU contains approximately 100 IU/mL of human coagulation
factor VIII (rDNA),
simoctocog alfa after reconstitution.
Vihuma 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU human coagulation factor VIII
(rDNA), simoctocog alfa.
Vihuma 500 IU contains approximately 200 IU/mL of human coagulation
factor VIII (rDNA),
simoctocog alfa after reconstitution.
Vihuma 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU human coagulation factor VIII
(rDNA), simoctocog alfa.
Vihuma 1000 IU contains approximately 400 IU/mL of human coagulation
factor VIII (rDNA),
simoctocog alfa after reconstitution.
Vihuma 2000 IU powder and solvent for solution for injection
Each vial contains nominally 2000 IU human coagulation factor VIII
(rDNA), simoctocog alfa.
Vihuma 2000 IU contains approximately 800 IU/mL of human coagulation
factor VIII (rDNA),
simoctocog alfa after reconstitution.
Vihuma 2500 IU powder and solvent for solution for injection
Each vial contains nominally 2500 IU human coagulation factor VIII
(rDNA), simoctocog alfa.
Vihuma 2500 IU contains approximately 1000 IU/mL of human coagulation
factor VIII (rDNA),
simoctocog alfa after reconstitution.
Vihuma 3000 IU powder and solvent for solution for injection
Each vial contains nominally 3000 IU human
Aqra d-dokument sħiħ
