RUXIENCE

Valsts: Izraēla

Valoda: angļu

Klimata pārmaiņas: Ministry of Health

Aktīvā sastāvdaļa:

RITUXIMAB

Pieejams no:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATĶ kods:

L01XC02

Zāļu forma:

CONCENTRATE FOR SOLUTION FOR INFUSION

Kompozīcija:

RITUXIMAB 10 MG/ML

Ievadīšanas:

I.V

Receptes veids:

Required

Ražojis:

PFIZER MANUFACTURING BELGIUM NV, BELGIUM

Ārstniecības joma:

RITUXIMAB

Ārstēšanas norādes:

Ruxience is indicated for:Non-Hodgkin’s lymphoma (NHL):Ruxience is indicated for the treatment of patients with relapsed or refractory low-grade or follicular, B-cell non-hodgkin’s lymphoma.Ruxience is indicated for the treatment of previously untreated patients with low-grade or follicular lymphoma in combination with chemotherapyRuxience is indicated for the treatment of patients with CD20 positive diffuse large B-cell nonHodgkin's lymphoma in combination with CHOP chemotherapy.Ruxience maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.Chronic lymphocytic leukaemia (CLL):Ruxience in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. Rheumatoid arthritis:Ruxience 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:Ruxience, 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 vulgaris:Ruxience is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris (PV).

Autorizācija datums:

2021-06-23

Produkta apraksts

Ruxience LPD CC 8
Page Ϭ of ΚΚ
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RUXIENCE
®
1.
NAME OF THE MEDICINAL PRODUCT
Ruxience
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ruxience 100 mg concentrate for solution for infusion
Each mL contains 10 mg of rituximab.
Each 10 mL vial contains 100 mg of rituximab.
Ruxience 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
This medicinal product contains less than 1 mmol sodium (23 mg) per
dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear to slightly opalescent, colourless to pale brownish-yellow
liquid.
Ruxience is a biosimilar medicinal product that has been demonstrated
to be similar in quality, safety
and efficacy to the reference medicinal product MabThera
®
10mg/ml I.V. Please be aware of any
differences in the indication between the biosimilar medicinal product
and the reference product. The
biosimilar is not to be switched with the reference medicinal product
unless specifically stated
otherwise. More detailed information regarding biosimilar medicinal
products is available on the
website of the Ministry of Health:
https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/Registration/Pages/Biosimilars.aspx
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ruxience is indicated for the following indications:
Non-Hodgkin’s lymphoma (NHL)
Ruxience is indicated for the treatment of patients with relapsed or
refractory low-grade or follicular,
B-cell non-hodgkin's lymphoma.
Ruxience i