LINADEX 10 CAPSULES 10 MG

Pays: Singapour

Langue: anglais

Source: HSA (Health Sciences Authority)

Ingrédients actifs:

Lenalidomide (Form H1)

Disponible depuis:

HETERO SINGAPORE PTE. LTD.

Code ATC:

L04AX04

forme pharmaceutique:

CAPSULE

Composition:

Lenalidomide (Form H1) 10.000 mg

Mode d'administration:

ORAL

Type d'ordonnance:

Prescription Only

Fabriqué par:

HETERO LABS LIMITED (Unit-V)

Statut de autorisation:

ACTIVE

Date de l'autorisation:

2023-04-18

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LINADEX 5MG, 10MG, 15MG, 25MG HARD CAPSULES
LINADEX 5MG, 10MG,
15MG, 25MG HARD CAPSULES
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 Linadex is and what it is used for
2. What you need to know before you take Linadex
3. How to take Linadex
4. Possible side effects
5. How to store Linadex
6. Content of the pack and other information
1. WHAT LINADEX IS AND WHAT IT IS USED FOR
WHAT LINADEX IS
Linadex contains the active substance 'lenalidomide'. This medicine
belongs to a group of medicines
which affect how your immune system works.
WHAT LINADEX IS USED FOR
Linadex 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
Linadex 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
Linadex is taken with other medicine:
·
an anti-inflammatory medicine called 'dexamethasone'.
You will take this other medicine at the start of treatment

Résumé des caractéristiques du produit

LINADEX 5/10/15/25
LENALIDOMIDE CAPSULES 5 mg/10 mg/15 mg/25 mg
NAME OF THE MEDICINAL PRODUCT
LINADEX 5 CAPSULES 5 MG
LINADEX 10 CAPSULES 10 MG
LINADEX 15 CAPSULES 15 MG
LINADEX 25 CAPSULES 25 MG
FORMULATION
LINADEX 5 (Lenalidomide Capsules 5 mg)
Each hard gelatin capsules contains: Lenalidomide 5 mg
LINADEX 10 (Lenalidomide Capsules 10 mg)
Each hard gelatin capsules contains: Lenalidomide 10 mg
LINADEX 15 (Lenalidomide Capsules 15 mg)
Each hard gelatin capsules contains: Lenalidomide 15 mg
LINADEX 25 (Lenalidomide Capsules 25 mg)
Each hard gelatin capsules contains: Lenalidomide 25 mg
DESCRIPTION:
LENALIDOMIDE CAPSULES 5 MG
White opaque cap and white opaque body, size '2' hard gelatin capsules
imprinted with ' H' on cap and 'L2' on body, filled with off white to
pale
yellow color powder.
LENALIDOMIDE CAPSULES 10 MG
Orange opaque cap and white opaque body, size '0' hard gelatin
capsules imprinted with ' H' on cap and 'L4' on body, filled with off
white to pale
yellow color powder.
LENALIDOMIDE CAPSULES 15 MG
Red opaque cap and white opaque body, size '0' hard gelatin capsules
imprinted with ' H' on cap and 'L5' on body, filled with off white to
pale
yellow color powder.
LENALIDOMIDE CAPSULES 25 MG
White opaque cap and white opaque body, size '0' hard gelatin capsules
imprinted with ' H' on cap and 'L7' on body, filled with off white to
pale
yellow color powder.
Lenalidomide is described chemically as I.)
3-(4-Amino-1-oxo1,3-dihydro-2H-isoindol-2-yl) piperidine- 2,6-dione
ii.) 3-(4-Amino-1,3-dihydro-1-oxo-
2H-isoindol-2-yl)-2,6-piperidinedione iii.)
1-oxo-2(2,6-dioxopiperidine-3-yl)-4-aminoisoindoline. The molecular
formula is C H N O and the
13
13
3
3
molecular weight is 259.27
The chemical structure of Lenalidomide is:
Lenalidomide is an off-white to pale-yellow powder and pKa acid value
is found as less than 1.0. Slightly soluble in dimethyl formamide.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Lenalidomide as monotherapy is indicated for the maintenance treatment
of adult patients with newly diagnosed mu