Rituzena (previously Tuxella)
Nazione: Unione Europea
Lingua: inglese
Fonte: EMA (European Medicines Agency)
Foglio illustrativo
(PIL)
18-02-2019
Scheda tecnica
(SPC)
18-02-2019
Relazione pubblica di valutazione
(PAR)
26-09-2017
Principio attivo:
rituximab
Commercializzato da:
Celltrion Healthcare Hungary Kft.
Codice ATC:
L01XC02
INN (Nome Internazionale):
rituximab
Gruppo terapeutico:
Antineoplastic agents
Area terapeutica:
Lymphoma, Non-Hodgkin; Microscopic Polyangiitis; Leukemia, Lymphocytic, Chronic, B-Cell; Wegener Granulomatosis
Indicazioni terapeutiche:
Rituzena is indicated in adults for the following indications:Non-Hodgkin’s lymphoma (NHL)Rituzena is indicated for the treatment of previously untreated patients with stage III IV follicular lymphoma in combination with chemotherapy.Rituzena monotherapy is indicated for treatment of patients with stage III IV follicular lymphoma who are chemo resistant or are in their second or subsequent relapse after chemotherapy.Rituzena is indicated for the treatment of patients with CD20 positive diffuse large B cell non Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.Chronic lymphocytic leukaemia (CLL)Rituzena 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 Rituzenaor patients refractory to previous Rituzena plus chemotherapy.Granulomatosis with polyangiitis and microscopic polyangiitisRituzena, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).
Dettagli prodotto:
Revision: 7
Stato dell'autorizzazione:
Withdrawn
Data dell'autorizzazione:
2017-07-13
Foglio illustrativo
78
B. PACKAGE LEAFLET
79
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RITUZENA 100 MG CONCENTRATE FOR SOLUTION FOR INFUSION
rituximab
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Rituzena is and what it is used for
2.
What you need to know before you use Rituzena
3.
How to use Rituzena
4.
Possible side effects
5.
How to store Rituzena
6.
Contents of the pack and other information
1.
WHAT RITUZENA IS AND WHAT IT IS USED FOR
WHAT RITUZENA IS
Rituzena contains the active substance “rituximab”. This is a type
of protein called a “monoclonal
antibody”. It is designed to stick to a type of white blood cell
called “B-Lymphocyte”. When
sticking to the surface of this cell, rituximab causes the cell to
die.
WHAT RITUZENA IS USED FOR
Rituzena may be used for the treatment of several different conditions
in adults. Your doctor may
prescribe Rituzena for the treatment of:
A)
NON-HODGKIN’S LYMPHOMA
This is a disease of the lymph tissue (part of the immune system) that
affects B-Lymphocytes.
Rituzena can be given alone or with other medicines called
“chemotherapy”.
B)
CHRONIC LYMPHOCYTIC LEUKAEMIA
Chronic lymphocytic leukaemia (CLL) is the most common form of adult
leukaemia. CLL affects
B-lymphocytes, which originate in the bone marrow and develop in the
lymph nodes. Patients with
CLL have too many abnormal lymphocytes, which accumulate mainly in the
bone marrow and blood.
The spread of these abnorm
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Scheda tecnica
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Rituzena 100 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg of rituximab.
Each mL of concentrate contains 10mg 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.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rituzena is indicated in adults for the following indications:
Non-Hodgkin’s lymphoma (NHL)
Rituzena is indicated for the treatment of previously untreated
patients with stage III-IV follicular
lymphoma in combination with chemotherapy.
Rituzena monotherapy is indicated for treatment of patients with stage
III-IV follicular lymphoma
who are chemo-resistant or are in their second or subsequent relapse
after chemotherapy.
Rituzena is indicated for the treatment of patients with CD20 positive
diffuse large B cell
non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide,
doxorubicin, vincristine,
prednisolone) chemotherapy.
Chronic lymphocytic leukaemia (CLL)
Rituzena 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
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