REVLIMID 25 MG

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

LENALIDOMIDE

Disponible desde:

NEOPHARM SCIENTIFIC LTD

Código ATC:

L04AX04

formulario farmacéutico:

HARD CAPSULE

Composición:

LENALIDOMIDE 25 MG

Vía de administración:

PER OS

tipo de receta:

Required

Fabricado por:

CELGENE EUROPE LTD, UK

Grupo terapéutico:

LENALIDOMIDE

Área terapéutica:

LENALIDOMIDE

indicaciones terapéuticas:

Multiple Myeloma (MM)Revlimid is indicated for the treatment of multiple myeloma.Myelodysplastic Syndromes REVLIMID is indicated for patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.Revlimid 7.5 mg is not indicated for treatment in MDS.Mantle Cell LymphomaREVLIMID is indicated for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL).Follicular lymphomaRevlimid in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma.

Fecha de autorización:

2014-04-30

Información para el usuario

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) 1986
This medicine is dispensed with a doctor's prescription only
REVLIMID 2.5 MG, 5 MG, 7.5 MG, 10 MG, 15 MG, 20 MG, 25 MG
HARD CAPSULES
Each hard capsule contains:
Lenalidomide 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg or 25 mg.
INACTIVE INGREDIENTS AND ALLERGENS: see section ‘IMPORTANT
INFORMATION ABOUT SOME OF
THIS MEDICINE’S INGREDIENTS’, and section 6 ‘ADDITIONAL
INFORMATION’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine.
If you have any further questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their medical condition is
similar to yours.
In addition to the leaflet, Revlimid has a Patient Information
Brochure. This brochure
contains important safety information that you need to know, before
starting and during
treatment with Revlimid and you should act according to it. The
brochure focuses on the
risk of birth defects to an unborn baby. Read the Patient Information
Brochure and the
Patient Information Leaflet before you begin taking the medicine. Keep
the brochure for
future reference if necessary.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Revlimid is used in adult patients for:
•
Multiple myeloma
•
Myelodysplastic syndromes (MDS)
•
Mantle cell lymphoma
(MCL)
•
Follicular lymphoma
Revlimid 7.5 mg is not indicated for treatment of myelodysplastic
syndromes.
THERAPEUTIC GROUP: The medicine belongs to a group of medicines which
affect how your immune
system works.
How Revlimid works
Revlimid works by affecting the body’s immune system and directly
attacking the cancer. It
works in a number of different ways:
•
by stopping the cancer cells developing
•
by stopping blood vessels growing in the cancer
•
by stimulating part of the immune system to attack the cancer cells
MULTIPLE MYELOMA
Multiple mye

Ficha técnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Revlimid 2.5 mg, hard capsules
Revlimid 5 mg, hard capsules
Revlimid 7.5 mg, hard capsules
Revlimid 10 mg, hard capsules
Revlimid 15 mg, hard capsules
Revlimid 20 mg, hard capsules
Revlimid 25 mg, hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Revlimid 2.5 mg hard capsules
Each capsule contains 2.5 mg of lenalidomide.
Excipient(s) with known effect
Each capsule contains 73.5 mg of lactose (as anhydrous lactose).
Revlimid 5 mg hard capsules
Each capsule contains 5 mg of lenalidomide.
Excipient(s) with known effect
Each capsule contains 147 mg of lactose (as anhydrous lactose).
Revlimid 7.5 mg hard capsules
Each capsule contains 7.5 mg of lenalidomide.
Excipient(s) with known effect
Each capsule contains 144.5 mg of lactose (as anhydrous lactose).
Revlimid 10 mg hard capsules
Each capsule contains 10 mg of lenalidomide.
Excipient(s) with known effect
Each capsule contains 294 mg of lactose (as anhydrous lactose).
Revlimid 15 mg hard capsules
Each capsule contains 15 mg of lenalidomide.
Excipient(s) with known effect
Each capsule contains 289 mg of lactose (as anhydrous lactose).
Revlimid 20 mg hard capsules
Each capsule contains 20 mg of lenalidomide.
Excipient(s) with known effect
Each capsule contains 244.5 mg of lactose (as anhydrous lactose).
Revlimid 25 mg hard capsules
Each capsule contains 25 mg of lenalidomide.
Excipient(s) with known effect
Each capsule contains 200 mg of lactose (as anhydrous lactose).
2
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Revlimid 2.5 mg hard capsules
Blue-green/white capsules, size 4, 14.3 mm, marked “REV 2.5 mg”.
Revlimid 5 mg hard capsules
White capsules, size 2, 18.0 mm, marked “REV 5 mg”.
Revlimid 7.5 mg hard capsules
Pale yellow/white capsules, size 2, 18.0 mm, marked “REV 7.5 mg”.
Revlimid 10 mg hard capsules
Blue-green/pale yellow capsules, size 0, 21.7 mm, marked “REV 10
mg”.
Revlimid 15 mg hard capsules
Pale blue/white capsules, siz