Lenalidomide Teva Capsules Hard 15mg

Krajina: Malta

Jazyk: angličtina

Zdroj: Malta Medicines Authority

Aktívna zložka:

LENALIDOMIDE

Dostupné z:

Teva B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

ATC kód:

L04AX04

INN (Medzinárodný Name):

LENALIDOMIDE 15 mg

Forma lieku:

HARD CAPSULE

Zloženie:

LENALIDOMIDE 15 mg

Typ predpisu:

POM

Terapeutické oblasti:

IMMUNOSUPPRESSANTS

Stav Autorizácia:

Withdrawn

Dátum Autorizácia:

2018-08-10

Príbalový leták

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LENALIDOMIDE TEVA 10 MG HARD CAPSULES
LENALIDOMIDE TEVA 15 MG HARD CAPSULES
LENALIDOMIDE TEVA 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 Teva is and what it is used for
2.
What you need to know before you take Lenalidomide Teva
3.
How to take Lenalidomide Teva
4.
Possible side effects
5.
How to store Lenalidomide Teva
6.
Contents of the pack and other information
1.
WHAT LENALIDOMIDE TEVA IS AND WHAT IT IS USED FOR
WHAT LENALIDOMIDE TEVA IS
Lenalidomide Teva contains the active substance ‘lenalidomide’.
This medicine belongs to a group of
medicines which affect how your immune system works.
Lenalidomide Teva is used in adults for Multiple myeloma.
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’.
Newly diagnosed multiple myeloma – in patients who have had a bone
marrow transplant
Lenalidomide Teva is used on its own as maintenance therapy after
patients have recovered enough
following a bone marrow transplant.
Newly diagnosed multiple myeloma – in patients who cannot have a
bone marrow transplant
Lenalidomide Teva is taken with other medic

Súhrn charakteristických

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lenalidomide Teva 10 mg hard capsules
Lenalidomide Teva 15 mg hard capsules
Lenalidomide Teva 25 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lenalidomide Teva 10 mg hard capsules
Each capsule contains lenalidomide hydrochloride hydrate corresponding
to 10 mg of lenalidomide.
Lenalidomide Teva 15 mg hard capsules
Each capsule contains lenalidomide hydrochloride hydrate corresponding
to 15 mg of lenalidomide.
Lenalidomide Teva 25 mg hard capsules
Each capsule contains lenalidomide hydrochloride hydrate corresponding
to 25 mg of lenalidomide.
Excipients with known effect:
Lenalidomide Teva 10 mg hard capsules:
Each capsule contains 0.9 mg of sodium.
Lenalidomide Teva 15 mg hard capsules:
Each capsule contains 1.35 mg of sodium.
Lenalidomide Teva 25 mg hard capsules:
Each capsule contains 2.25 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Lenalidomide Teva 10 mg hard capsules
Hard, non-transparent capsules, size “2” (approximately 18 mm in
length), imprinted in black
with ‘10’ on ivory body and with green cap, containing off-white
to pale yellow or beige powder or
compressed powder.
Lenalidomide Teva 15 mg hard capsules
Hard, non-transparent capsules, size “1” (approximately 19.4 mm in
length), imprinted in black
with ‘15’ on white body and with blue cap, containing off-white to
pale yellow or beige powder or
compressed powder.
Lenalidomide Teva 25 mg hard capsules
Hard, non-transparent capsules, size “0” (approximately 21.7 mm in
length), imprinted in black
with ‘25’ on white body and with white cap, containing off-white
to pale yellow or beige powder or
compressed powder.
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4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Multiple myeloma
Lenalidomide Teva as monotherapy is indicated for the maintenance
treatment of adult patients with
newly diagnosed multiple myeloma who have undergone autologous stem
cell transplantation.
Len