BeneFix 500IU powder and solvent for solution for injection

País: Armênia

Língua: inglês

Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes ativos:

nonacog alfa

Disponível em:

Wyeth Farma S.A.

Código ATC:

B02BD04

DCI (Denominação Comum Internacional):

nonacog alfa

Dosagem:

500IU

Forma farmacêutica:

powder and solvent for solution for injection

Unidades em pacote:

glass vial and solvent in pre-filled syringe 5ml, vial adapter, sterile infusion set, (2) alcohol swabs, plaster, gauze pad

Tipo de prescrição:

Prescription

Status de autorização:

Registered

Data de autorização:

2019-07-09

Folheto informativo - Bula

1
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PACKAGE LEAFLET: INFORMATION FOR THE USER
BENEFIX 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
BENEFIX 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
BENEFIX 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
BENEFIX 1500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
BENEFIX 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
BENEFIX 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
nonacog alfa (recombinant coagulation factor IX)
Read all of this leaflet carefully before you start taking 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, pharmacist or
nurse.
-
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 BeneFIX is and what it is used for
2.
What you need to know before you take BeneFIX
3.
How to take BeneFIX
4.
Possible side effects
5.
How to store BeneFIX
6.
Contents of the pack and other information
1.
WHAT BENEFIX IS AND WHAT IT IS USED FOR
BeneFIX is an injectable clotting (coagulation) factor IX product that
is produced by recombinant
DNA technology. The active ingredient in BeneFIX is nonacog alfa.
People who are born with
haemophilia B (Christmas disease) lack sufficient factor IX to control
bleeding. BeneFIX works by
replacing factor IX in haemophilia B patients to enable their blood to
clot.
BeneFIX is used for the treatment and prevention of bleeding in
patients with haemophilia B
(congenital factor IX deficiency) in all age groups.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BENEFIX
DO NOT TAKE BENEFIX
-
if you are allergic to nonacog alfa or any of the other ingredients of
this medicine (listed in
section 6).
-
if you are allergic to hamster proteins.
WARNINGS AND PRE

Características técnicas

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ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
BeneFIX 250 IU powder and solvent for solution for injection
BeneFIX 500 IU powder and solvent for solution for injection
BeneFIX 1000 IU powder and solvent for solution for injection
BeneFIX 1500 IU powder and solvent for solution for injection
BeneFIX 2000 IU powder and solvent for solution for injection
BeneFIX 3000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
BeneFIX 250 IU powder and solvent for solution for injection
Each vial contains nominally 250 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 mL (0.234%) sodium chloride
solution for injection, each mL
of the solution contains approximately 50 IU nonacog alfa.
BeneFIX 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 mL (0.234%) sodium chloride
solution for injection, each mL
of the solution contains approximately 100 IU nonacog alfa.
BeneFIX 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 mL (0.234%) sodium chloride
solution for injection, each mL
of the solution contains approximately 200 IU nonacog alfa.
BeneFIX 1500 IU powder and solvent for solution for injection
Each vial contains nominally 1500 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 mL (0.234%) sodium chloride
solution for injection, each mL
of the solution contains approximately 300 IU nonacog alfa.
BeneFIX 2000 IU powder and solvent for solution for injection
Each vial contains nominally 2000 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 mL (0.234%) sodium chloride
solution for injection, each mL
of the solution contains approximately 400 IU