BENEFIX 2000 IUVIAL

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

COAGULATION FACTOR IX RECOMBINANT-RFIX

Available from:

PFIZER PHARMACEUTICALS ISRAEL LTD

ATC code:

B02BD04

Pharmaceutical form:

LYOPHILIZED POWDER FOR INJECTION

Composition:

COAGULATION FACTOR IX RECOMBINANT-RFIX 2000 IU

Administration route:

I.V

Prescription type:

Required

Manufactured by:

WYETH FARMA S.A, SPAIN

Therapeutic group:

COAGULATION FACTOR IX

Therapeutic area:

COAGULATION FACTOR IX

Therapeutic indications:

Benefix is indicated for the control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency or christmas disease), including control and prevention of bleeding in surgical settings, in previously treated patients (PTP) and previously untreated patients (PUP). Benefix is not indicated for the treatment of other factor deficiencies (e.g. factors II,VII, and X)' nor for the treatment of hemophilia A patients with inhibitors to factor VIII, nor for the reversal of coumarin-induced anticoagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.

Authorization date:

2020-11-30

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986
This medicine is dispensed with a doctor’s prescription only
BENEFIX
® 250 IU
BENEFIX
® 500 IU
BENEFIX
® 1000 IU
BENEFIX
® 2000 IU
POWDER AND DILUENT FOR SOLUTION FOR INTRAVENOUS )IV( INJECTION
EACH VIAL CONTAINS:
RECOMBINANT COAGULATION FACTOR IX 250IU, 500IU, 1000IU, 2000IU
For a list of inactive ingredients and allergens, see section 6
“Further information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet
contains concise information about this medicine. If you have any
further
questions, consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others.
It may harm them, even if it seems to you that their medical condition
is
similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Benefix
®
is indicated for prevention and reduction of the rate of bleeding
episodes in patients with hemophilia B (congenital factor IX
deficiency or
Christmas disease), including control of bleeding in surgical
settings, in
previously treated patients and previously untreated patients.
Benefix
®
is not indicated for the treatment of other factor deficiencies
(factors
II, VII, X), not for treatment of hemophilia A patients with
inhibitors to factor
VIII, not for reversal of coumarin (Warfarin)-induced anticoagulation
and not
for treatment of bleeding due to low levels of liver-dependent
coagulation
factors.
THERAPEUTIC GROUP: coagulation factor.
2. BEFORE USING THIS MEDICINE
Do not use this medicine if: you had a life-threatening, immediate
hypersensitivity, including anaphylaxis, to the active ingredient or
to any of
the other ingredients in this medicine, listed in section 6, including
sensitivity
to hamster protein.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
CALL YOUR DOCTOR RIGHT AWAY IF BLEEDING IS NOT CONTROLLED AFTER
INJECTING
THE MEDICINE.
BEFORE TREATMENT WITH BENEFIX
®
, TELL YOUR DOCTOR IF:
•
you have any allergies, including allergies to hamsters.

Summary of Product characteristics

Benefix LPD CC 12 Dec 2022
1
2022-0079930
BENEFIX
®
-
NAME OF THE MEDICINAL PRODUCT
BeneFIX 250 IU
BeneFIX 500 IU
BeneFIX 1000 IU
BeneFIX 2000 IU
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Benefix 250 IU contains nominally 250 IU nonacog alfa
(recombinant coagulation
factor IX).
Each vial of Benefix 500 IU contains nominally 500 IU nonacog alfa
(recombinant coagulation
factor IX).
Each vial of Benefix 1000 IU contains nominally 1000 IU nonacog alfa
(recombinant coagulation
factor IX).
Each vial of Benefix 20000 IU contains nominally 2000 IU nonacog alfa
(recombinant coagulation
factor IX).
For the full list of excipients, see section 11.
PHARMACEUTICAL FORM
BeneFIX 250 IU, 500 IU, 1000 IU, 2000 IU powder and solvent for
solution for injection
White powder and clear and colorless solvent.
1 INDICATIONS AND USAGE
1.1
CONTROL AND PREVENTION
OF
BLEEDING EPISODES IN HEMOPHILIA B
BeneFIX
®
, Coagulation Factor IX (Recombinant), is indicated for the control
and
prevention of bleeding episodes in adult and pediatric patients with
hemophilia B (congenital factor IX deficiency or Christmas disease).
1.2
PERI
-OPERATIVE MANAGEMENT IN PATIENTS WITH HEMOPHILIA B
BeneFIX, Coagulation Factor IX (Recombinant), is indicated for
peri-operative
management
in adult and pediatric patients with hemophilia B.
BeneFIX, Coagulation Factor IX (Recombinant), is
NOT
indicated for:
a.
treatment of other factor deficiencies (e.g., factors II, VII, VIII,
and X),
b.
treatment of hemophilia A patients with inhibitors to factor VIII,
c.
reversal of coumarin-induced anticoagulation,
d.
treatment of bleeding due to low levels of liver-dependent coagulation
factors.
2.DOSAGE AND ADMINISTRATION
Benefix LPD CC 12 Dec 2022
2
2022-0079930
2.1GENERAL CONSIDERATIONS FOR ADMINISTRATION FOR
INTRAVENOUS USE AFTER RECONSTITUTION
•
TREATMENT WITH BENEFIX, COAGULATION FACTOR IX (RECOMBINANT), SHOULD
BE INITIATED UNDER THE SUPERVISION OF A PHYSICIAN EXPERIENCED IN THE
TREATMENT OF HEMOPHILIA B.
•
EACH VIAL OF BENEFIX HAS THE RFIX POTENCY IN THE