BENEFIX factor IX recombinant 1000 IU powder for injection vial and diluent syringe composite pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Nonacog alfa, Quantity: 1000 IU

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

factor IX (Recombinant)

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: polysorbate 80; histidine; sucrose; glycine

Administration route:

Intravenous

Units in package:

1 x powder for injection vial + 1 x diluent syringe

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

BeneFIX is indicated 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. BeneFIX is not indicated for the treatment of other factor deficiencies (e.g. factors II, VII and X), nor for the treatment of haemophilia A patients with inhibitors to factor VIII, nor for the reversal of coumarin induced anti-coagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.

Product summary:

Visual Identification: Lyophilised white powder.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2007-09-27

Patient Information leaflet

BENEFIX
®
B
e
n
e
F
I
X
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING BENEFIX?
BeneFIX contains the active ingredient nonacog alfa, a coagulation
factor IX product. BeneFIX is used to control and treat bleeding
and prevent bleeding in people with haemophilia B. People with
haemophilia B are deficient in coagulation factor IX.
For more information, see Section 1. Why am I using BeneFIX? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BENEFIX?
Do not use BeneFIX if you have had an allergic reaction to nonacog
alfa, hamster proteins or any of the ingredients listed at the end
of the CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant
or are breastfeeding.
For more information, see Section 2. What should I know before I use
BeneFIX? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with BeneFIX and affect how it works. For
more information, see Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE BENEFIX?
•
BeneFIX comes in five dosage strengths. Your doctor will prescribe the
dosage strength and dose that is right for you.
•
BeneFIX is given by injection directly into your veins.
•
The BeneFIX powder needs to be reconstituted (made-up) before use. Use
only the materials provided in the pack for dissolving
the BeneFIX powder with the sodium chloride solution and injecting the
made-up BeneFIX solution.
•
Your doctor, nurse or pharmacist will show you how to use BeneFIX
before you use it for the first time.
More instructions can be found in Section 4. How do I use BeneFIX? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BENEFIX?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
BeneFIX.
•
See your doctor immediately if your bleeding does not stop as
expected.
•
St

Summary of Product characteristics

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Page 1 of 14
AUSTRALIAN
PRODUCT
INFORMATION
–
BENEFIX
® (NONACOG ALFA)
1.
NAME OF THE MEDICINE
Nonacog alfa
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The potency (in international units, IU) is determined using an
_in vitro_
one-stage clotting assay
against
the
World
Health
Organisation
(WHO)
International
Standard
for
Factor
IX
concentrate. One IU is the amount of factor IX activity present in 1
mL of pooled, normal
human plasma. The specific activity of BeneFIX is greater than or
equal to 200 IU per
milligram of protein. BeneFIX is not derived from human blood and
contains no preservatives
or added animal or human components. BeneFIX is inherently free from
the risk of
transmission of human blood-borne pathogens such as HIV, hepatitis
viruses and parvovirus.
BeneFIX is formulated as a sterile, non-pyrogenic, lyophilised powder
preparation. BeneFIX
is intended for intravenous (IV) injection. It is available in single
use vials containing the
labelled amount of factor IX activity, expressed in IU. Each vial
contains nominally 250, 500,
1000, 2000 or 3000 IU of nonacog alfa.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3.
PHARMACEUTICAL FORM
Sterile, lyophilised white powder for injection.
All dosage strengths yield a clear, colourless solution upon
reconstitution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BeneFIX is indicated 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.
BeneFIX is not indicated for the treatment of other factor
deficiencies (e.g. factors II, VII and
X), nor for the treatment of haemophilia A patients with inhibitors to
factor VIII, nor for the
reversal of coumarin-induced anti-coagulation, nor for the treatment
of bleeding due to low
levels of liver-dependent coagulation factors.
Version: pfpbenev10719
Supersedes: pfpbenev10217
Page 2 of 14
4.2 DO