LENALIDOMIDE-TEVA CAPSULE 25MG

Quốc gia: Singapore

Ngôn ngữ: Tiếng Anh

Nguồn: HSA (Health Sciences Authority)

Thành phần hoạt chất:

Lenalidomide hydrochloride hydrate eqv Lenalidomide

Sẵn có từ:

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Mã ATC:

L04AX04

Dạng dược phẩm:

CAPSULE

Thành phần:

Lenalidomide hydrochloride hydrate eqv Lenalidomide 25 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

Prescription Only

Sản xuất bởi:

PLIVA Croatia Ltd.

Tình trạng ủy quyền:

ACTIVE

Ngày ủy quyền:

2022-04-14

Tờ rơi thông tin

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LENALIDOMIDE-TEVA CAPSULE 25MG
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.
Content of the pack and other information
1. WHAT LENALIDOMIDE-TEVA IS AND WHAT IT
IS USED FOR
WHAT LENALIDOMIDE IS
Lenalidomide-Teva contains the active substance
‘lenalidomide’. This medicine belongs to a group of
medicines which affect how your immune system works.
WHAT LENALIDOMIDE-TEVA IS USED FOR
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 medicine:
•
an anti-inflammatory medicine called �

Đặc tính sản phẩm

1.
NAME OF THE MEDICINAL PRODUCT
LENALIDOMIDE-TEVA CAPSULE 25MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hard, non-transparent capsules with black mark 25 on white body and
with white cap
Each hard capsule contains 25mg of Lenalidomide in the form of
Lenalidomide hydrochloride hydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lenalidomide as monotherapy is indicated for the maintenance treatment
of adult patients with newly diagnosed multiple myeloma who have
undergone autologous
stem cell transplantation.
Lenalidomide in combination with dexamethasone is indicated for the
treatment of previously untreated multiple myeloma patients who are
not eligible for transplant.
Lenalidomide in combination with dexamethasone is indicated for the
treatment of multiple myeloma patients who have received at least one
prior therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Lenalidomide should only be prescribed by Specialist Physician
experienced in the management of malignancies, who have undergone the
lenalidomide educational
programme on Pregnancy Prevention Programme.
Treatment must be initiated and monitored under the supervision of
physicians experienced in the management of multiple myeloma (MM).
For all indications described below:
•
Dose is modified based upon clinical and laboratory findings (see
section 4.4).
•
Dose adjustments, during treatment and restart of treatment, are
recommended to manage grade 3 or 4 thrombocytopenia, neutropenia, or
other grade 3 or
4 toxicity judged to be related to lenalidomide.
•
In case of neutropenia, the use of growth factors in patient
management should be considered.
•
If less than 12 hours has elapsed since missing a dose, the patient
can take the dose. If more than 12 hours has elapsed since missing a
dose at the normal time,
the patient should not take the dose, but take the next dose at the
normal time on the following day.
_Posology_
_Newly diagnosed multiple myeloma (NDM