BeneFIX

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Nonacog alfa 2000 [iU] (+ 10% overage)

Available from:

Pfizer New Zealand Limited

INN (International Name):

Nonacog alfa 2000 IU (+ 10% overage)

Dosage:

2000 IU

Pharmaceutical form:

Powder for injection with diluent

Composition:

Active: Nonacog alfa 2000 [iU] (+ 10% overage) Excipient: Glycine Histidine Polysorbate 80 Sucrose Sodium chloride Water for injection

Units in package:

Combination pack, vial + pre-filled syringe diluent + infusion set, 1 dose unit

Class:

General sale

Prescription type:

General sale

Manufactured by:

Wyeth Biopharma, Division of Wyeth Pharmaceuticals Inc., a Subsidiary of Pfizer Inc.

Therapeutic indications:

for the control and prevention of haemorrhagic episodes in patients with haemophilia B (congenital factor IX deficiency or Christmas disease), including control and prevention of bleeding in surgical settings.

Product summary:

Package - Contents - Shelf Life: Combination pack, vial + pre-filled syringe diluent + infusion set - 1 dose units - 6 months unopened stored at or below 30°C. After which cannot be returned to refrigerated conditions. 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, Pre-filled glass, Diluent - 10 mL - 48 months from date of manufacture stored at or below 30°C - Vial, glass, Powder for reconstitution - 2000 IU - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2006-05-16

Patient Information leaflet

BENEFIX
®
1
BENEFIX
®
_nonacog alfa (rch) (recombinant coagulation factor IX), 250, 500,
1000, 2000, 3000 IU /vial_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about BeneFIX. It
does not contain all of the available
information. It does not take the
place of talking to your doctor or
hospital pharmacist.
IF YOU HAVE ANY CONCERNS ABOUT
USING BENEFIX, ASK YOUR DOCTOR OR
HOSPITAL PHARMACIST.
Your doctor and hospital pharmacist
have more information.
KEEP THIS LEAFLET WITH YOUR
BENEFIX.
You may need to read it again.
WHAT BENEFIX IS
BeneFIX, nonacog alfa (rch) is a
coagulation factor IX product that is
produced by recombinant
technology. Mammalian cells, which
have the DNA for human coagulation
factor IX put in them, are grown in
large amounts in cell culture
laboratories. These cells make
recombinant human factor IX, which
is released into cell culture media and
then very highly purified. The
recombinant factor IX does not
contain any human blood,
preservatives, or added animal or
human components.
WHAT BENEFIX IS USED
FOR
People with haemophilia B
(Christmas disease) are deficient in
coagulation factor IX. BeneFIX
works by replacing factor IX to
enable blood to clot.
BeneFIX is used for the control and
treatment of bleeding and the
prevention of bleeding in people with
haemophilia B.
BeneFIX has been approved for use
in haemophilia B. Ask your doctor if
you have any questions about why
BeneFIX has been prescribed for
you.
There is no evidence that BeneFIX is
addictive.
BeneFIX is not expected to affect
your ability to drive a car or operate
machinery.
BEFORE YOU USE
BENEFIX
_WHEN YOU MUST NOT USE IT_
DO NOT USE BENEFIX IF YOU ARE
ALLERGIC TO HAMSTER PROTEINS OR ANY
OF THE INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
Signs of allergy include a skin rash,
itching, chest tightness, wheezing,
dizziness, hives, faintness, rapid
heartbeat, blurred vision, shortness of
breath and/or a swollen face. If any
of these signs occur, stop using
BeneFIX and see your

Summary of Product characteristics

Version: pfdbenev11218
Supersedes: pfdbenev10117
Page 1 of 13
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
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 2000 IU powder and solvent for solution for injection.
BeneFIX 3000 IU powder and solvent for solution for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of BeneFIX 250 IU powder for injection contains nominally
250 IU* of 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.
Each vial of BeneFIX 500 IU powder for injection contains nominally
500 IU* of 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.
Each vial of BeneFIX 1000 IU powder for injection contains nominally
1000 IU* of 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.
Each vial of BeneFIX 2000 IU powder for injection contains nominally
2000 IU* of 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 nonacog alfa.
Each vial of BeneFIX 3000 IU powder for injection contains nominally
3000 IU* of 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
600 IU nonacog alfa.
*The potency (in international units, IU) is determined using an
_in vitro_
one-stage clotting assay
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