Lenalidomide Synthon Capsules Hard 5mg

国家: 马耳他

语言: 英文

来源: Medicines Authority

有效成分:

LENALIDOMIDE

可用日期:

Synthon BV Microweg 22, 6545 CM Nijmegen, Netherlands

ATC代码:

L04AX04

INN（国际名称）:

LENALIDOMIDE 5 mg

药物剂型:

HARD CAPSULE

组成:

LENALIDOMIDE 5 mg

处方类型:

POM

治疗领域:

IMMUNOSUPPRESSANTS

授权状态:

Withdrawn

授权日期:

2018-11-12

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LENALIDOMIDE SYNTHON 2.5 MG HARD CAPSULES
LENALIDOMIDE SYNTHON 5 MG HARD CAPSULES
LENALIDOMIDE SYNTHON 7.5 MG HARD CAPSULES
LENALIDOMIDE SYNTHON 10 MG HARD CAPSULES
LENALIDOMIDE SYNTHON 15 MG HARD CAPSULES
LENALIDOMIDE SYNTHON 20 MG HARD CAPSULES
LENALIDOMIDE SYNTHON 25 MG HARD CAPSULES
lenalidomide
READ ALL OF 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 or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lenalidomide Synthon is and what it is used for
2.
What you need to know before you take Lenalidomide Synthon
3.
How to take Lenalidomide Synthon
4.
Possible side effects
5.
How to store Lenalidomide Synthon
6.
Contents of the pack and other information
1
WHAT LENALIDOMIDE SYNTHON IS AND WHAT IT IS USED FOR
Lenalidomide Synthon contains the active substance lenalidomide. This
medicine belongs to a group
of medicines which affect how your immune system works.
Lenalidomide Synthon is used in adults for
•
Multiple Myeloma
•
Myelodysplastic syndromes
•
Follicular lymphoma
MULTIPLE MYELOMA
Multiple myeloma is a type of cancer which affects a certain kind of
white blood cell, called the
plasma cell.
These c
ells collect in the bone marrow and divide, becoming out of control.
This can damage the
bones and kidneys.
Multiple myeloma generally cannot be cured. However, the signs and
symptoms can be greatly
reduced or disappear for a period of time. This is called a
‘response’.
Newly diagnosed multiple myeloma - in patients who have had a bone
marrow transplant
Lenalidomide Synthon is used on its own as mainten

产品特点

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1.
NAME OF THE MEDICINAL PRODUCT
Lenalidomide Synthon 2.5 mg hard capsules
Lenalidomide Synthon 5 mg hard capsules
Lenalidomide Synthon 7.5 mg hard capsules
Lenalidomide Synthon 10 mg hard capsules
Lenalidomide Synthon 15 mg hard capsules
Lenalidomide Synthon 20 mg hard capsules
Lenalidomide Synthon 25 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 2.5 mg of lenalidomide.
Each capsule contains 5 mg of lenalidomide.
Each capsule contains 7.5 mg of lenalidomide.
Each capsule contains 10 mg of lenalidomide.
Each capsule contains 15 mg of lenalidomide.
Each capsule contains 20 mg of lenalidomide.
Each capsule contains 25 mg of lenalidomide.
Excipient(s) with known effect:
Each capsule contains 33.2 mg of lactose.
Each capsule contains 66.4 mg of lactose.
Each capsule contains 99.7 mg of lactose.
Each capsule contains 132.9 mg of lactose.
Each capsule contains 199.3 mg of lactose.
Each capsule contains 265.8 mg of lactose.
Each capsule contains 332.2 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Opaque white body and opaque green to light green cap, with a length
of approximately14.3 mm,
marked “L9NL” and “2.5”.
Opaque white body and opaque white cap, with a length of approximately
18.0 mm, marked
“L9NL” and “5”.
Opaque white body and opaque yellow cap, with a length of
approximately 18.0 mm, marked
“L9NL” and “7.5”.
Opaque yellow body and opaque green to light green cap, with a length
of approximately 21.7 mm,
marked “L9NL” and “10”.
Opaque white body and opaque blue to light blue cap, with a length of
approximately 21.7 mm,
marked “L9NL” and “15”.
Opaque blue to light blue body and opaque green to light green cap,
with a length of approximately
21.7 mm, marked “L9NL” and “20”.
Opaque white body and opaque white cap, with a length of approximately
21.7 mm, marked
“L9NL” and “25”.
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4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Multiple myelom