Rixubis nonacog gamma (rch) 3000 IU powder and solvent for solution for injection glass vials

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nonacog gamma, Quantity: 3000 IU

Available from:

Takeda Pharmaceuticals Australia Pty Ltd

INN (International Name):

nonacog gamma,water for injections

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: histidine; sodium chloride; calcium chloride dihydrate; mannitol; sucrose; polysorbate 80

Administration route:

Intravenous

Units in package:

1 powder vial, 1 WFI vial and 1 BaxJect II Needleless Transfer Device

Prescription type:

exempt from scheduling - Appendix A; prescription medicine

Therapeutic indications:

1) Routine prophylaxis of bleeding episodes in patients with haemophilia B 2) Treatment and prevention of bleeding episodes in patients with haemophilia B (congenital factor IX deficiency) 3) Peri-operative management in patients with haemophilia B

Product summary:

Visual Identification: White or almost white, lyophilised powder and diluent for solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-02-05

Patient Information leaflet

RIXUBIS
®
_nonacog gamma (rch) (recombinant coagulation factor IX), 250, 500,
1000, 2000, 3000 IU /vial_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about RIXUBIS. It does
not contain all of the available
information. All medicines have risks
and benefits. Your doctor has
weighed the risks of using your
medicine against the benefit that it
will have for you.
It does not take the place of talking to
your doctor or pharmacist.
IF YOU HAVE ANY CONCERNS ABOUT
HAVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Please read this leaflet carefully
before using your medicine as it
contains information about your
medicine.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT RIXUBIS IS
RIXUBIS, nonacog gamma (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 RIXUBIS IS USED
FOR
People with haemophilia B
(Christmas disease) are deficient in
coagulation factor IX. RIXUBIS
works by replacing factor IX to
enable blood to clot.
Your medicine is used to prevent and
control bleeding in people with
haemophilia B.
Your doctor may give you RIXUBIS
when you have surgery.
Your medicine can reduce the
number of bleeding episodes when
used regularly (prophylaxis).
BEFORE YOU USE
RIXUBIS
To make sure that your medicine is
suitable for you, it is important to tell
your doctor or pharmacist if any of
the points below apply to you. If
there is anything you do not
understand, ask your doctor or
pharmacist to explain.
Do not use RIXUBIS if you:
•
are allergic to hamsters.
•
are allergic to any ingredients in
RIXUBIS (see "What is in
RIXUBIS?").
_WHAT SHOULD I TEL

Summary of Product characteristics

RIXUBIS PI V1.0 CCDS22820150519
Page 1
AUSTRALIAN PRODUCT INFORMATION
RIXUBIS
® (RECOMBINANT COAGULATION FACTOR IX (RFIX), NONACOG GAMMA (RCH))
1
NAME OF THE MEDICINE
Recombinant Coagulation Factor IX (rFIX), Nonacog gamma (rch)), rFIX
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The product is available in the following strengths: 250 IU, 500 IU,
1000 IU, 2000 IU, and
3000 IU.
The product concentration differs for each strength as every strength
is reconstituted with the
accompanying 5 mL of water for injections.
The specific activity of rFIX is ≥ 200 IU factor IX per mg.
COMPOSITION
TABLE 1. UNIT FORMULATION: AFTER RECONSTITUTION WITH WATER FOR
INJECTIONS TO 5 ML
RIXUBIS
250 IU
500 IU
1000 IU
2000 IU
3000 IU
_ACTIVE INGREDIENT: _
Nonacog gamma
[Recombinant Coagulation
FIX (rch)]
_ _
250 IU
_ _
500 IU
_ _
1000 IU
2000 IU
_ _
3000 IU
_APPROXIMATE PRODUCT _
_CONCENTRATION: _
(IU rFIX per mL of
reconstituted solution)
_ _
_ _
_ _
50 IU/mL
_ _
_ _
100 IU/mL
_ _
_ _
200 IU/mL
_ _
_ _
400 IU/mL
_ _
_ _
600 IU/mL
The amounts of the inactive ingredients are constant in all strengths.
For the full list of
excipients, see Section 6.1 LIST OF EXCIPIENTS -Table 13.
3
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
APPEARANCE
White, lyophilised powder and diluent for solution, for intravenous
administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
RIXUBIS is indicated for:
•
Routine prophylaxis of bleeding episodes in patients with haemophilia
B
•
Treatment and prevention of bleeding episodes in patients with
haemophilia B (congenital
factor IX deficiency)
•
Peri-operative management in patients with haemophilia B
RIXUBIS PI V1.0 CCDS22820150519
Page 2
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL
Treatment should be initiated under the supervision of a physician
experienced in the
treatment of haemophilia.
It is recommended that prescribed doses of RIXUBIS are expressed as
‘International Units’
(written in full) of factor IX.
Patients and their caregivers should be adequately trained