Rixathon

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

rituximab

Διαθέσιμο από:

Sandoz GmbH

Φαρμακολογική κατηγορία (ATC):

L01FA01

INN (Διεθνής Όνομα):

rituximab

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Leukemia, Lymphocytic, Chronic, B-Cell; Wegener Granulomatosis; Microscopic Polyangiitis; Pemphigus

Θεραπευτικές ενδείξεις:

Rixathon is indicated in adults for the following indications:Non-Hodgkin’s lymphoma (NHL)Rixathon is indicated for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma in combination with chemotherapy.Rixathon maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy.Rixathon 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.Rixathon 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.Rixathon 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)Rixathon 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 rituximab or patients refractory to previous rituximab plus chemotherapy.See section 5.1 for further information.Rheumatoid arthritisRixathon 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.Rituximab 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 polyangiitisRixathon, 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).Rixathon, 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 vulgarisRixathon is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).

Περίληψη προϊόντος:

Revision: 12

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2017-06-15

Φύλλο οδηγιών χρήσης

72
B. PACKAGE LEAFLET
73
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RIXATHON 100 MG CONCENTRATE FOR SOLUTION FOR INFUSION
RIXATHON 500 MG CONCENTRATE FOR SOLUTION FOR INFUSION
rituximab
READ ALL OF 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 Rixathon is and what it is used for
2.
What you need to know before you are given Rixathon
3.
How Rixathon is given
4.
Possible side effects
5.
How to store Rixathon
6.
Contents of the pack and other information
1.
WHAT RIXATHON IS AND WHAT IT IS USED FOR
WHAT RIXATHON IS
Rixathon 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 RIXATHON IS USED FOR
Rixathon may be used for the treatment of several different conditions
in adults and children. Your
doctor may prescribe Rixathon 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 Rixathon can be given alone or with other medicines called
“chemotherapy”.
In adult patients where the treatment is working, Rixathon may be used
as a maintenance treatment for
2 years after completing the initial treatment.
In children and adolescents, rituximab is given in combination with
“chemotherapy”.
B)
CHRONIC LYMPHOCYTIC LEUKAEMIA (CLL)
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.
Patients

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Rixathon 100 mg concentrate for solution for infusion
Rixathon 500 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rixathon 100 mg concentrate for solution for infusion
Each mL contains 10 mg of rituximab.
Each 10 mL vial contains 100 mg of rituximab.
Rixathon 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.
Excipient with known effect
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 (sterile concentrate).
Clear, colourless to slightly yellowish liquid with pH of 6.3 – 6.7
and osmolality of ≥ 240 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rixathon is indicated in adults for the following indications:
Non-Hodgkin’s lymphoma (NHL)
Rixathon is indicated for the treatment of previously untreated adult
patients with stage III-IV
follicular lymphoma in combination with chemotherapy.
Rixathon maintenance therapy is indicated for the treatment of adult
follicular lymphoma patients
responding to induction therapy.
Rixathon 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.
3
Rixathon is indicated for the treatment of adult patients with CD20
positive diffuse large B cell non-
Hodgkin’s lymph