BeneFix

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

nonacog alfa

Available from:

Wyeth Farma S.A.

INN (International Name):

nonacog alfa

Dosage:

500IU

Pharmaceutical form:

powder for solution for injection

Prescription type:

Prescription

Patient Information leaflet

TEXT SIZE
THE BODY TEXT
ON THIS A/W IS AT:
8.5 PT
THE SMALLEST TEXT
ON THIS A/W IS AT:
8.5 PT
Black
Profile
Perigord House
Damastown Industrial Park
Dublin 15
Ireland
Telephone [phone]
[e-mail]
ww.perigordpremedia.com
w
Pil BENEFIX ES/UK/PT
Leaflet
Algete (Spain)
PAA086208
PAA074287
PAA086208
N/A
311281
2
06 Jun 2017
MRP COMPONENT DESCRIPTION:
COMPONENT
PACKAGING PLANT
ITEM CODE
OLD ITEM CODE
PHARMA CODE (2D)
BARCODE NO.
JOB NO.
PASS NO.
DATE LAST MODIFIED
TINT VALUES
BLACK - 10%
BLACK - 20%
BLACK - 30%
PROSPECTO: INFORMACIÓN PARA EL USUARIO
BENEFIX 250 UI POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
BENEFIX 500 UI POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
BENEFIX 1000 UI POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
BENEFIX 1500 UI POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
BENEFIX 2000 UI POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
BENEFIX 3000 UI POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Nonacog alfa (factor IX de coagulación recombinante)
LEA TODO EL PROSPECTO DETENIDAMENTE ANTES DE EMPEZAR
A USAR ESTE MEDICAMENTO, PORQUE CONTIENE INFORMACIÓN
IMPORTANTE PARA USTED.
−
Conserve este prospecto, ya que puede tener que volver a
leerlo.
−
Si tiene alguna duda, consulte a su médico, farmacéutico o
enfermero.
−
Este medicamento se le ha recetado solamente a usted, y no
debe dárselo a otras personas aunque tengan los mismos
síntomas que usted, ya que puede perjudicarles.
−
Si experimenta efectos adversos, consulte a su médico,
farmacéutico o enfermero, incluso si se trata de efectos
adversos que no aparecen en este prospecto. Ver sección 4.
CONTENIDO DEL PROSPECTO:
1.
Qué es BeneFIX y para qué se utiliza
2.
Qué necesita saber antes de empezar a usar BeneFIX
3.
Cómo usar BeneFIX
4.
Posibles efectos adversos
5.
Conservación de BeneFIX
6.
Contenido del envase e información adicional
1.
QUÉ ES BENEFIX Y PARA QUÉ SE UTILIZA
BeneFIX es un producto de factor IX de la coagulación inyectable
obtenido por tecnología de ADN recombinante. La sustancia
activa de BeneF

Summary of Product characteristics

13
1.
NAME OF THE MEDICINAL PRODUCT
BeneFIX 500 IU powder and solvent for solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
The potency (IU) is determined using the European Pharmacopoeia
one-stage clotting assay. The
specific activity of BeneFIX is not less than 200 IU/mg protein.
BeneFIX contains recombinant coagulation factor IX, (INN = nonacog
alfa). Nonacog alfa is a
purified protein that has 415 amino acids in a single chain. It has a
primary amino acid sequence that
is comparable to the Ala
148
allelic form of plasma-derived factor IX, and some post-translational
modifications of the recombinant molecule are different from those of
the plasma-derived molecule.
Recombinant coagulation factor IX is a glycoprotein that is secreted
by genetically engineered
mammalian cells derived from a Chinese hamster ovary (CHO) cell line.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
White/almost white powder and clear and colourless solvent.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with haemophilia B
(congenital factor IX
deficiency).
BeneFIX can be used for all age groups.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be under the supervision of a physician experienced
in the treatment of
haemophilia.
Treatment monitoring
During the course of treatment, appropriate determination of factor IX
levels is advised to guide the
dose to be administered and the frequency of repeated infusions.
Individual patients may vary in their
response to factor IX, demonstrating different half-lives and
recoveries. Dose based on bodyweight
may require adjustment in underweight or overweight patients. In the
case of major surgical
in