MabThera SC

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Rituximab 120 mg/mL;  

Dostupné z:

Roche Products (NZ) Ltd

INN (Medzinárodný Name):

Rituximab 120 mg/mL

Dávkovanie:

1400mg/11.7mL

Forma lieku:

Solution for injection

Zloženie:

Active: Rituximab 120 mg/mL   Excipient: Histidine Histidine hydrochloride Hyaluronidase Methionine Polysorbate 80 Trehalose dihydrate Water for injection

Typ predpisu:

Prescription

Výrobca:

Genentech Inc

Terapeutické indikácie:

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.

Prehľad produktov:

Package - Contents - Shelf Life: Vial, glass, single dose, - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 48 hours opened stored at 2° to 8°C (Refrigerate, do not freeze). Physical and chemical stability demonstrated only, protect from direct sunlight 8 hours opened stored at or below 30°C. Physical and chemical stability demonstrated only, protect from direct sunlight

Dátum Autorizácia:

2013-04-15

Príbalový leták

Mabthera
®
SC CMI (NHL and CLL) 20230201
1
_ _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
MABTHERA
® SC
_RITUXIMAB _
1400 mg solution for subcutaneous injection for non-Hodgkin’s
Lymphoma and 1600mg solution for
subcutaneous injection for chronic lymphocytic leukaemia
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Mabthera SC.
This leaflet answers some common questions about Mabthera SC for
subcutaneous (under the skin)
injection. 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
SC against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT MABTHERA SC IS USED FOR
Mabthera SC contains the active ingredient rituximab.
Mabthera SC 1400mg is used to treat non-Hodgkin’s lymphoma. Mabthera
SC 1600mg is used to treat
chronic lymphocytic leukaemia. Non-Hodgkin’s lymphoma and chronic
lymphocytic leukaemia are types
of blood cancers.
Mabthera SC 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 SC 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 SC may be used on its own or together with chemotherapy .
Your doctor may have prescribed Mabthera SC for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY MABTHERA SC HAS
BEEN PRESCRIBED FOR YOU.
This medicine is available only with a doctor’s prescription.
Mabthera
®
SC CMI

Súhrn charakteristických

1
Mabthera SC 20230201
NEW ZEALAND DATA SHEET
MABTHERA
® SC (RITUXIMAB)
1.
PRODUCT NAME
Mabthera 1400mg solution for subcutaneous injection (Mabthera SC
1400mg)
Mabthera 1600mg solution for subcutaneous injection (Mabthera SC
1600mg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rituximab 120mg/mL
Each vial of Mabthera SC 1400mg solution for subcutaneous injection
contains
1400 mg/11.7mL rituximab.
Each vial of Mabthera SC 1600mg solution for subcutaneous injection
contains
1600 mg/13.4mL of rituximab.
_EXCIPIENTS WITH KNOWN EFFECT _
Mabthera SC contains the excipient vorhyaluronidase alfa, an enzyme
used to increase the
dispersion and absorption of co-administered drugs when administered
subcutaneously
(see sections 4.4 and 4.6).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Mabthera solution for SC injection is a sterile, preservative-free non
pyrogenic clear to
opalescent, colourless to yellowish solution in a single-dose vial.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_NON-HODGKIN’S LYMPHOMA _
Mabthera SC 1400mg 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 SC 1400mg is indicated for maintenance treatment of patients
with CD20 positive,
low grade or follicular, B-cell non-Hodgkin’s lymphoma.
_CHRONIC LYMPHOCYTIC LEUKAEMIA _
Mabthera SC 1600mg in combination with chemotherapy is indicated for
the treatment of
patients with chronic lymphocytic leukaemia.
2
Mabthera SC 20230201
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL
Substitution by any other biological medicinal product requires the
consent of the
prescribing physician.
Mabthera SC should be administered as a SC