Ritemvia

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

rituximab

Dostupné z:

Celltrion Healthcare Hungary Kft.

ATC kód:

L01XC02

INN (Medzinárodný Name):

rituximab

Terapeutické skupiny:

Antineoplastic agents

Terapeutické oblasti:

Lymphoma, Non-Hodgkin; Microscopic Polyangiitis; Wegener Granulomatosis

Terapeutické indikácie:

Ritemvia is indicated in adults for the following indications:Non-Hodgkin’s lymphoma (NHL) Ritemvia is indicated for the treatment of previously untreated patients with stage III, IV follicular lymphoma in combination with chemotherapy.Ritemvia maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.Ritemvia 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.Ritemvia 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.Granulomatosis with polyangiitis and microscopic polyangiitis.Ritemvia, 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).

Prehľad produktov:

Revision: 8

Stav Autorizácia:

Withdrawn

Dátum Autorizácia:

2017-07-13

Príbalový leták

68
B. PACKAGE LEAFLET
Medicinal product no longer authorised
69
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RITEMVIA 100 MG CONCENTRATE FOR SOLUTION FOR INFUSION
RITEMVIA 500 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 Ritemvia is and what it is used for
2.
What you need to know before you use Ritemvia
3.
How to use Ritemvia
4.
Possible side effects
5.
How to store Ritemvia
6.
Contents of the pack and other information
1.
WHAT RITEMVIA IS AND WHAT IT IS USED FOR
WHAT RITEMVIA IS
Ritemvia 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 RITEMVIA IS USED FOR
Ritemvia may be used for the treatment of several different conditions
in adults and children. Your
doctor may prescribe Ritemvia 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, Ritemvia can be given alone or with other medicines called
“chemotherapy”.
In adult patients where the treatment is working, Ritemvia may be
continued for 2 years after
completing the initial treatment.
In children and adolescents, Ritemvia is given in combination with
“ch

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
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
Ritemvia 100 mg concentrate for solution for infusion
Ritemvia 500 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ritemvia 100mg concentrate for solution for infusion
Each mL contains 10 mg of rituximab.
Each 10 mL vial contains 100 mg of rituximab.
Ritemvia 500mg 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. 6mg) 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 6.3 – 6.8 and osmolality of 329
- 387 mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ritemvia is indicated in adults for the following indications:
Non-Hodgkin’s lymphoma (NHL)
Ritemvia is indicated for the treatment of previously untreated adult
patients with stage III-IV
follicular lymphoma in combination with chemotherapy.
Ritemvia maintenance therapy is indicated for the treatment of adult
follicular lymphoma
patients responding to induction therapy.
Ritemvia monotherapy is indicated for treatment of adul