MabThera
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
29-11-2023
Karatteristiċi tal-prodott
(SPC)
29-11-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
11-12-2020
Ingredjent attiv:
rituximab
Disponibbli minn:
Roche Registration GmbH
Kodiċi ATC:
L01XC02
INN (Isem Internazzjonali):
rituximab
Grupp terapewtiku:
Antineoplastic agents
Żona terapewtika:
Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Leukemia, Lymphocytic, Chronic, B-Cell
Indikazzjonijiet terapewtiċi:
MabThera is indicated in adults for the following indications:Non‑Hodgkin’s lymphoma (NHL)MabThera is indicated for the treatment of previously untreated adult patients with stage III‑IV follicular lymphoma in combination with chemotherapy.MabThera maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy.MabThera monotherapy is indicated for treatment of adult patients with stage III‑IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.MabThera is indicated for the treatment of adult patients with CD20 positive diffuse large B cell non‑Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.MabThera in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL).Chronic lymphocytic leukaemia (CLL)MabThera in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. 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 in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease‑modifying anti‑rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.MabThera has been shown to reduce the rate of progression of joint damage as measured by X‑ray and to improve physical function, when given in combination with methotrexate.Granulomatosis with polyangiitis and microscopic polyangiitisMabThera, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).MabThera, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active GPA (Wegener’s) and MPA.Pemphigus vulgarisMabThera is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Sommarju tal-prodott:
Revision: 60
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
1998-06-02
Fuljett ta 'informazzjoni
125
B PACKAGE LEAFLET
126
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MABTHERA 100 MG CONCENTRATE FOR SOLUTION FOR INFUSION
MABTHERA 500 MG CONCENTRATE FOR SOLUTION FOR INFUSION
rituximab
READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1
What MabThera is and what it is used for
2
What you need to know before you use MabThera
3
How to use MabThera
4
Possible side effects
5
How to store MabThera
6
Contents of the pack and other information
1
WHAT MABTHERA IS AND WHAT IT IS USED FOR WHAT MABTHERA IS
MabThera contains the active substance “rituximab”. This is a type
of protein called a “monoclonal
antibody”. It sticks to the surface of a type of white blood cell
called “B-Lymphocyte”. When
rituximab sticks to the surface of this cell, the cell dies.
WHAT MABTHERA IS USED FOR
MabThera may be used for the treatment of several different conditions
in adults and children. Your
doctor may prescribe MabThera for the treatment of:
A)
NON-HODGKIN’S LYMPHOMA
This is a disease of the lymph tissue (part of the immune system) that
affects a type of white blood cell
called B-Lymphocytes.
In adults MabThera can be given alone or with other medicines called
“chemotherapy”.
In adult patients where the treatment is working, MabThera may be used
as a maintenance treatment
for 2 years after completing the initial treatment.
In children and adolescents, MabThera is given in combination with
“chemotherapy”.
B)
CHRONIC LYMPHOCYTIC LEUKAEMIA
Chronic lymphocytic leukaemia (CLL) is the most common form of adult
leukaemia. CLL affects a
particular lymphocyte, the B cell, which originates from the bone
marrow and develops in the lymph
nodes. Pati
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1
NAME OF THE MEDICINAL PRODUCT
MabThera 100 mg concentrate for solution
for infusion MabThera 500 mg concentrate for
solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MabThera 100 mg concentrate for solution for infusion
Each mL contains 10 mg of rituximab.
Each 10 mL vial contains 100 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 in adults for the following
indications: Non-Hodgkin’s lymphoma (NHL)
MabThera is indicated for the treatment of previously untreated adult
patients with
stage III-IV follicular lymphoma in combination with chemotherapy.
MabThera maintenance therapy is indicated for the treatment of adult
follicular
lymphoma patients responding to induction therapy.
3
MabThera monotherapy is indicated for treatment of adult patients with
stage III-IV
follicular lymphoma who are chemoresistant or are in their second or
subsequent relapse
after chemotherapy.
MabThera is indicated for the treatment of adult patients with CD20
positive diffuse large
B cell non-Hodgkin’s lymphoma in combination with CHOP
(cyclophospha
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