REVLIMID 10 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LENALIDOMIDE

Available from:

NEOPHARM SCIENTIFIC LTD

ATC code:

L04AX04

Pharmaceutical form:

HARD CAPSULE

Composition:

LENALIDOMIDE 10 MG

Administration route:

PER OS

Prescription type:

Not required

Manufactured by:

CELGENE EUROPE LTD, UK

Therapeutic area:

LENALIDOMIDE

Therapeutic indications:

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..

Authorization date:

2014-04-30

Patient Information leaflet

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דבכנ ת/חקור ,ה/אפור
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, לע ךעידוהל החמש םרפואינ לש הרושיא
היוותה תפסות
רישכתל
:םי
REVLIMID 2.5 MG Hard Capsule דימילבר
2.5
ג"מ
החישק היילבט
REVLIMID 5 MG Hard Capsule דימילבר
5 ג"מ
החישק היילבט
REVLIMID 7.5 MG Hard Capsule דימילבר
7.5 ג"מ
החישק היילבט
REVLIMID 10 MG Hard Capsule דימילבר
10 ג"מ
החישק היילבט
REVLIMID 15 MG Hard Capsule דימילבר
15 ג"מ
החישק היילבט
REVLIMID 20 MG Hard Capsule דימילבר
20 ג"מ
החישק היילבט
REVLIMID 25 MG Hard Capsule דימילבר
25 ג"מ
החישק היילבט
םירמוחה
םיליעפה
:םתומכו
Revlimid 2.5 mg: each hard capsule contains 2.5 mg Lenalidomide.
Revlimid 5 mg: each hard capsule contains 5 mg Lenalidomide.
Revlimid 7.5 mg: each hard capsule contains 7.5 mg Lenalidomide.
Revlimid 10 mg: each hard capsule contains 10 mg Lenalidomide.
Revlimid 15 mg: each hard capsule contains 15 mg Lenalidomide.
Revlimid 20 mg: each hard capsule contains 20 mg Lenalidomide.
Revlimid 25 mg: each hard capsule contains 25 mg Lenalidomide.
:השדחה היוותהה חסונ
MULTIPLE MYELOMA
Revlimid is indicated for:
•The maintenance treatment of adult patients with newly diagnosed
multiple myeloma (MM) who
have undergone autologous stem cell transplantation.
• Previously untreated multiple myeloma in adult patients who are
not eligible for transplant.
• In combination with dexamethasone treatment of multiple myeloma
patients who have received
at least one prior therapy.
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 LYMPHOMA
REVLIMID is indicated for the treatment of adult patients with
relapsed and

Summary of Product characteristics

1
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, size 0, 21.7 mm, marked “REV 15 mg�