MABTHERA 10 MGML I.V

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

RITUXIMAB

Available from:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

ATC code:

L01XC02

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

RITUXIMAB 10 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

HOFFMANN LA ROCHE LTD, SWITZERLAND

Therapeutic group:

RITUXIMAB

Therapeutic area:

RITUXIMAB

Therapeutic indications:

MabThera is indicated for the following indications: * Non-Hodgkin’s lymphoma (NHL)MabThera is indicated for the treatment of patients with relapsed or refractory low-grade or follicular, B-cell non-hodgkin’s lymphoma.MabThera is indicated for the treatment of previously untreated patients with low-grade or follicular lymphoma in combination with chemotherapy MabThera is indicated for the treatment of patients with CD20 positive diffuse large B-cell non-Hodgkin's lymphoma in combination with CHOP chemotherapy. MabThera maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. * Chronic lymphocytic leukaemia (CLL)MabThera in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including MabThera or patients refractory to previous MabThera plus chemotherapy.* Rheumatoid arthritisMabThera is indicated, in combination with methotrexate, to reduce signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis who had an inadequate response or intolerance to one or more TNF antagonist therapies.* Granulomatosis with polyangiitis and Microscopic polyangiitisMabThera, in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis (WG) and Microscopic polyangiitis (MPA). *Pemphigus vulgarisMabThera is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris (PV).

Authorization date:

2023-09-30

Patient Information leaflet

יאמ
2019
10MG/ML IV
)
RITUXIMAB
(
HERA
T
AB
M
CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION
,ה/רקי ת/חקור ,ה/רקי ה/אפור
לע םכעידוהל תשקבמ מ"עב (לארשי)
הקיטבצמרפ שור תרבח
רישכתל תפסונ היוותה םושיר
הרטבמ
10
ל"מ/ג"מ
IV
םירגובמב לופיטל ,
םע
ב סירגלוו סוגיפמפ
וא תינוניב הלחמ תגרד
הרומח
.
:ןמקלדכ וניה רישכתה לש אלמה תויוותהה
חסונ
יוותהה
תו
מושרה
תו
ל רישכת
:לארשיב
Non-Hodgkin’s lymphoma (NHL)
MabThera is indicated for the treatment of patients with relapsed or
refractory
low-grade or follicular, B-cell non-hodgkin’s lymphoma.
MabThera is indicated for the treatment of previously untreated
patients with
low-grade or follicular lymphoma in combination with chemotherapy
MabThera is indicated for the treatment of patients with CD20 positive
diffuse
large B-cell non-Hodgkin's lymphoma in combination with CHOP
chemotherapy.
MabThera maintenance therapy is indicated for the treatment of
follicular
lymphoma patients responding to induction therapy.
Chronic lymphocytic leukaemia (CLL)
MabThera in combination with chemotherapy is indicated for the
treatment of
patients with previously untreated and relapsed/refractory chronic
lymphocytic
leukaemia. Only limited data are available on efficacy and safety for
patients
previously treated with monoclonal antibodies including MabThera or
patients
refractory to previous MabThera plus chemotherapy.
Rheumatoid arthritis
MabThera is indicated, in combination with methotrexate, to reduce
signs and
symptoms in adult patients with moderately to severely active
rheumatoid
arthritis who had an inadequate response or intolerance to one or more
TNF
antagonist therapies.
Granulomatosis with polyangiitis and Microscopic polyangiitis
MabThera, in combination with glucocorticoids, is indicated for the
treatment of
adult patients with Granulomatosis with polyangiitis (GPA)
(Wegener’s
Granu

Summary of Product characteristics

1
MABTHERA 10 MG/ML PI VERSION 10
MABTHERA
®
10MG/ML I.V.
RITUXIMAB
CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION
1.
NAME OF THE MEDICINAL PRODUCT
MabThera 10mg/mL I.V.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MabThera 100 mg concentrate for solution for infusion
Each mL contains 10 mg of rituximab.
Each 10 mL vial contains100 mg of rituximab.
MabThera 500 mg concentrate for solution for infusion
Each mL contains 10 mg of rituximab.
Each 50 mL vial 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 effects:
Each 10 mL vial contains 2.3 mmol (52.6 mg) sodium.
Each 50 mL vial contains 11.5 mmol (263.2 mg) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless liquid with pH of 6.2 – 6.8 and osmolality of 324
- 396 mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MabThera is indicated for the following indications:
Non-Hodgkin’s lymphoma (NHL)
MabThera is indicated for the treatment of patients with relapsed or
refractory low-grade or follicular,
B-cell non-hodgkin’s lymphoma.
MabThera is indicated for the treatment of previously untreated
patients with low-grade or follicular
lymphoma in combination with chemotherapy
2
MabThera is indicated for the treatment of patients with CD20 positive
diffuse large B-cell non-
Hodgkin's lymphoma in combination with CHOP chemotherapy.
MabThera maintenance therapy is indicated for the treatment of
follicular lymphoma patients
responding to induction therapy.
Chronic lymphocytic leukaemia (CLL)
MabThera in combination with chemotherapy is indicated fo