Lenalidomide Lotus 2.5mg hard capsules

Riik: Malta

keel: inglise

Allikas: Malta Medicines Authority

Toimeaine:

LENALIDOMIDE

Saadav alates:

Lotus Support Services S.R.L. 47 Theodor Pallady Blvd. 2nd Office, Entrance B, 1st Floor 3rd District Bucharest, Romania

ATC kood:

L04AX04

INN (Rahvusvaheline Nimetus):

LENALIDOMIDE 2.5 mg

Ravimvorm:

HARD CAPSULE

Koostis:

LENALIDOMIDE 2.5 mg

Retsepti tüüp:

POM

Terapeutiline ala:

IMMUNOSUPPRESSANTS

Toote kokkuvõte:

Licence number in the source country: NOT APPLICAPABLE

Volitamisolek:

Withdrawn

Loa andmise kuupäev:

2020-08-12

Infovoldik

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Lenalidomide Lotus 2.5 mg hard capsules
Lenalidomide Lotus 5 mg hard capsules
Lenalidomide Lotus 7.5 mg hard capsules
Lenalidomide Lotus 10 mg hard capsules
Lenalidomide Lotus 15 mg hard capsules
Lenalidomide Lotus 20 mg hard capsules
Lenalidomide Lotus 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 Lotus is and what it is used for
2.
What you need to know before you take Lenalidomide Lotus
3.
How to take Lenalidomide Lotus
4.
Possible side effects
5.
How to store Lenalidomide Lotus
6.
Contents of the pack and other information
1.
WHAT LENALIDOMIDE LOTUS IS AND WHAT IT IS USED FOR
WHAT LENALIDOMIDE LOTUS IS
Lenalidomide Lotus contains the active substance ‘lenalidomide’.
This medicine belongs to a group
of medicines which affect how your immune system works.
WHAT LENALIDOMIDE LOTUS IS USED FOR
Lenalidomide Lotus is used in adults for:
-
Multiple myeloma
-
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 cells 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’.
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Newly diagnosed multiple myeloma in patients who have had a bone
ma

Toote omadused

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Lenalidomide Lotus 2.5 mg hard capsules
Lenalidomide Lotus 5 mg hard capsules
Lenalidomide Lotus 7.5 mg hard capsules
Lenalidomide Lotus 10 mg hard capsules
Lenalidomide Lotus 15 mg hard capsules
Lenalidomide Lotus 20 mg hard capsules
Lenalidomide Lotus 25 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lenalidomide Lotus 2.5 mg hard capsules
Each capsule contains 2.5 mg of lenalidomide.
Excipient with known effect:
Each capsule contains 53.5 mg of lactose.
Lenalidomide Lotus 5 mg hard capsules
Each capsule contains 5 mg of lenalidomide.
Excipient with known effect:
Each capsule contains 107 mg of lactose.
Lenalidomide Lotus 7.5 mg hard capsules
Each capsule contains 7.5 mg of lenalidomide.
Excipient with known effect:
Each capsule contains 160.5 mg of lactose.
Lenalidomide Lotus 10 mg hard capsules
Each capsule contains 10 mg of lenalidomide.
Excipient with known effect:
Each capsule contains 214 mg of lactose.
Lenalidomide Lotus 15 mg hard capsules
Each capsule contains 15 mg of lenalidomide.
Excipient with known effect:
Each capsule contains 120 mg of lactose.
Lenalidomide Lotus 20 mg hard capsules
Each capsule contains 20 mg of lenalidomide.
Excipient with known effect:
Each capsule contains 160 mg of lactose.
Lenalidomide Lotus 25 mg hard capsules
Each capsule contains 25 mg of lenalidomide.
Excipient with known effect:
Each capsule contains 200 mg of lactose.
For the full list of excipients, see section 6.1.
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3.
PHARMACEUTICAL FORM
Hard capsule.
Lenalidomide Lotus 2.5 mg hard capsules
A dark blue opaque cap and light orange opaque body, capsule shell
size No. 4, 14-15 mm,
imprinted in black ink with “LP” on the cap and “637” on the
body and filled with white powder.
Lenalidomide Lotus 5 mg hard capsules
A green opaque cap and light brown opaque body, capsule shell size No.
2, 18-19 mm, imprinted in
black ink with “LP” on the cap and “638” on the body and
filled with whit