Mabthera

Country: New Zealand

Bahasa: Inggeris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Rituximab 10 mg/mL (murine/human monoclonal antibody);  ;  ;  

Boleh didapati daripada:

Roche Products (NZ) Ltd

INN (Nama Antarabangsa):

Rituximab 10 mg/mL (murine/human monoclonal antibody)

Dos:

10 mg/mL

Borang farmaseutikal:

Concentrate for infusion

Komposisi:

Active: Rituximab 10 mg/mL (murine/human monoclonal antibody)       Excipient: Citric acid Hydrochloric acid Polysorbate 80 Sodium chloride Sodium citrate dihydrate Water for injection

Unit dalam pakej:

Vial, glass, 50 mL, 1 dose unit

Kelas:

Prescription

Jenis preskripsi:

Prescription

Dikeluarkan oleh:

Genentech Inc

Tanda-tanda terapeutik:

Mabthera is indicated for the treatment of patients with: · CD20 positive, previously untreated low-grade or follicular, B-cell non-Hodgkin's lymphoma in combination with chemotherapy. · CD20 positive, relapsed or chemoresistant low-grade or follicular, B-cell non-Hodgkin's lymphoma. · CD20 positive diffuse large B-cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy. Mabthera is indicated for maintenance treatment of patients with CD20 positive, low grade or follicular, B-cell non-Hodgkin's lymphoma.

Ringkasan produk:

Package - Contents - Shelf Life: Vial, glass, 50 mL - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 30 days diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Prepared with 0.9% aqueous saline solution 24 hours diluted stored at or below 30°C. Prepared with 0.9% aqueous saline solution 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze). Prepared with 5% aqueous dextrose solution 12 hours diluted stored at or below 30°C. Prepared with 5% aqueous dextrose solution - Vial, glass, 10 mL - 2 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 30 days diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Prepared with 0.9% aqueous saline solution 24 hours diluted stored at or below 30°C. Prepared with 0.9% aqueous saline solution 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze). Prepared with 5% aqueous dextrose solution 12 hours diluted stored at or below 30°C. Prepared with 5% aqueous dextrose solution

Tarikh kebenaran:

1997-06-03

Risalah maklumat

Mabthera

CMI (NHL & CLL)20230201
1
_ _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
MABTHERA
®
_NON-HODGKIN’S LYMPHOMA AND _
_ _
_ _
_ _
_ CHRONIC LYMPHOCYTIC LEUKAEMIA_
_ _
RITUXIMAB
100 MG IN 10 ML AND 500 MG IN 50 ML CONCENTRATE FOR SOLUTION FOR
INFUSION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about MABTHERA infusion.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you being given MABTHERA
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT MABTHERA IS USED FOR
MABTHERA contains the active ingredient rituximab.
MABTHERA is used to treat non-Hodgkin’s lymphoma and chronic
lymphocytic leukaemia (both are
types of blood cancer).
MABTHERA belongs to a group of medicines known as monoclonal
antibodies. Monoclonal antibodies
are proteins which specifically recognise and bind to another unique
protein called an antigen.
MABTHERA works by binding to an antigen on the surface of certain
white blood cells known as B
lymphocytes. It is the abnormally growing B lymphocytes that are
responsible for certain types of non-
Hodgkin’s lymphoma and chronic lymphocytic leukaemia. During the
process of binding to the antigen,
the abnormal growth of the B lymphocytes is stopped.
MABTHERA may be used on its own or together with other chemotherapy.
Your doctor, however, may have prescribed MABTHERA for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY MABTHERA HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with a doctor’s prescription.
Mabthera

CMI (NHL & CLL)20230201
2
_ _
BEFORE YOU ARE GIVEN MABTHERA
_WHEN YOU MUST NOT BE GIVEN MABTHERA _
YOU SHOULD NOT BE GIVEN MABTHERA IF:
•
YOU HAVE HAD AN ALLERGIC REACTION TO MABTHERA OR ANY OF THE
INGREDIENTS LISTED AT THE
END OF THIS LEAFLET
•
YOU

Ciri produk

MabThera 20230201
1
NEW ZEALAND DATA SHEET
MABTHERA
® (RITUXIMAB)
1.
PRODUCT NAME
MabThera (rituximab) concentrate for intravenous infusion 100mg
MabThera (rituximab) concentrate for intravenous infusion 500mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 10 mg of rituximab.
Each 10 mL vial of MabThera 100mg concentrate for intravenous (IV)
infusion contains
100 mg of rituximab.
Each 50 mL vial of MabThera 500mg concentrate for intravenous (IV)
infusion contains
500 mg of rituximab.
Rituximab
is
a
genetically
engineered
chimeric
mouse/human
monoclonal
antibody
representing a glycosylated immunoglobulin with human IgG1 constant
regions and murine
light
chain
and
heavy
chain
variable
region
sequences.
The
antibody
is
produced
by
mammalian
(Chinese
hamster
ovary)
cell
suspension
culture
and
purified
by
affinity
chromatography
and
ion
exchange,
including
specific
viral
inactivation
and
removal
procedures.
Excipients with known effect
MabThera 100mg contains 2.3 mmol (52.6 mg) sodium per 10mL vial.
MabThera 500mg contains 11.5 mmol (263.2 mg) sodium per 50mL vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
MabThera concentrate for solution for intravenous (IV) infusion is a
clear, colourless liquid
supplied in sterile, preservative-free, non-pyrogenic single-dose
vials.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NON-HODGKIN’S LYMPHOMA
MabThera is indicated for the treatment of patients with:
- CD20 positive, previously untreated low-grade or follicular, B-cell
non-Hodgkin’s
lymphoma in combination with chemotherapy,
- CD20 positive, relapsed or chemoresistant low-grade or follicular,
B-cell non-Hodgkin’s
lymphoma,
- CD20 positive diffuse large B-cell non-Hodgkin’s lymphoma in
combination with CHOP
(cyclophosphamide, doxorubicin, vincristine and prednisone)
chemotherapy.
MabThera is indicated for maintenance treatment of patients with CD20
positive, low grade or
follicular, B-cell non-Hodgkin’s lymphoma.
CHRONIC LYMPHOCYTIC LEUKAEMIA
MabThera in combinati