Rixathon Concentrate for Solution for Infusion 500mg50ml

Država: Malezija

Jezik: engleski

Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivni sastojci:

RITUXIMAB

Dostupno od:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International ime):

RITUXIMAB

Jedinice u paketu:

1 Units; 2 Units

Proizveden od:

LEK PHARMACEUTICALS D.D.

Svojstava lijeka

1.
NAME OF THE MEDICINAL PRODUCT
Rixathon Concentrate for Solution for Infusion 100mg/10ml
Rixathon Concentrate for Solution for Infusion 500mg/50ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100mg/10ml
Each 10 mL vial contains 100 mg of rituximab.
500mg/50ml
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.
Rixathon is a biosimilar medicine to the reference product MabThera.
Rixathon has been developed as a similar biological medicinal product
to MabThera and has been shown
to have a comparable quality, safety and efficacy profile to MabThera.
Therefore, switching with the
reference product is possible, as long as this is in agreement with
the treating physician in consultation with
the patient. However, automatic substitution (i.e the practice by
which a different product to that specified
on the prescription is dispensed to the patient without the prior
informed consent of the treating physician)
and active substance-based prescription cannot apply to biologicals,
including biosimilars.
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.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
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
NON-HODGKIN’S LYMPHOMA
Rixathon is indicated for the treatment of:
•
patients with relapsed or chemoresistant low-grade or follicular,
CD20-positive, B-cell non-Hodgkin’s
lymphoma;
•
previously untreated patients with stage III-IV follicular lymphoma in
comb