RIXUBIS

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

Nonacog gamma 200 IU/mL equivalent to 1000 IU/vial;  

Saatavilla:

Takeda New Zealand Limited

INN (Kansainvälinen yleisnimi):

Nonacog gamma 200 IU/mL (equivalent to 1000 IU/vial)

Annos:

200 IU/mL

Lääkemuoto:

Powder for injection

Koostumus:

Active: Nonacog gamma 200 IU/mL equivalent to 1000 IU/vial   Excipient: Calcium chloride dihydrate Histidine Mannitol Polysorbate 80 Sodium chloride Sucrose Water for injection

Prescription tyyppi:

General sale

Valmistaja:

Baxalta Manufacturing Sarl

Käyttöaiheet:

· Routine prophylaxis of bleeding episodes in patients with haemophilia B · Treatment & prevention of bleeding episodes in patients with haemophilia B (congenital factor IX deficiency) · Peri-operative management in patients with haemophilia B

Tuoteyhteenveto:

Package - Contents - Shelf Life: Combination pack, 1 vial active + 1 vial diluent - 1000 U - 36 months from date of manufacture stored at or below 30°C. do not freeze 3 hours reconstituted stored at or below 30°C. do not refrigerate or freeze - Vial, glass, diluent - 5 mL -   - Vial, glass, active component - 1000 U -  

Valtuutus päivämäärä:

2013-03-28

Pakkausseloste

RIXUBIS
1
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 S

Valmisteyhteenveto

NEW ZEALAND DATA SHEET
RIXUBIS Data Sheet V0.1 CCDS22820150519
Page 1
1 RIXUBIS (50 IU/mL, 100 IU/mL, 200 IU/mL, 400 IU/mL and 600 IU/mL
powder for injection)
RIXUBIS is available in the following strengths:
50 IU/mL equivalent to 250 IU,
100 IU/mL equivalent to 500 IU,
200 IU/mL equivalent to 1000 IU,
400 IU/mL equivalent to 2000 IU,
600 IU/mL equivalent to 3000 IU.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Nonacog gamma (rch), Recombinant Coagulation Factor
IX (rFIX).
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.
Unit Formulation: after reconstitution with water for injections to
5mL
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
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
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.
4.2
Dose and method of administration
_General _
Treatment should be initiated under the supervision of a physician
experienced in the treatment of
haemophilia.
NEW ZEALAND DATA SHEET
RIXUBIS Data Sheet V0.1 CCDS22820150519
Page 2
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 in the
correct administration technique
before