LENALIDOMIDE-TEVA lenalidomide (as hydrochloride monohydrate) 5 mg capsule blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

lenalidomide hydrochloride monohydrate, Quantity: 6.05 mg

Disponible desde:

Teva Pharma Australia Pty Ltd

formulario farmacéutico:

Capsule

Composición:

Excipient Ingredients: colloidal anhydrous silica; Gelatin; purified talc; microcrystalline cellulose; croscarmellose sodium; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Vía de administración:

Oral

Unidades en paquete:

21, 28, 14

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Multiple Myeloma (MM),Lenalidomide-Teva is indicated for the treatment of multiple myeloma.,Myelodysplastic Syndromes (MDS),Lenalidomide-Teva is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Resumen del producto:

Visual Identification: Lenalidomide capsules, 5 mg are hard, non-transparent capsules with black mark 5 on white body and with white cap.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Estado de Autorización:

Registered

Fecha de autorización:

2021-06-16

Información para el usuario

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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI has more details. If you are worried about using this
medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING LENALIDOMIDE-TEVA?
Lenalidomide-Teva contains the active ingredient lenalidomide (as
lenalidomide hydrochloride monohydrate). Lenalidomide-
Teva is used to treat patients with Multiple Myeloma.
Lenalidomide-Teva is also used to treat patients who have conditions
called
myelodysplastic syndromes (MDS) in whom the bone marrow does not
produce enough mature blood cells. For more information,
see Section 1. Why am I using Lenalidomide-Teva? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LENALIDOMIDE-TEVA?
Do not use if you have ever had an allergic reaction to
Lenalidomide-Teva or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2.
What should I know before I use Lenalidomide-Teva? in the
full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Lenalidomide-Teva and affect how it
works. A list of these medicines is in Section 3. What if I am
taking other medicines? in the full CMI.
4.
HOW DO I USE LENALIDOMIDE-TEVA?
•
Your doctor will tell you how much Lenalidomide-Teva to take and for
how long you will need to take it. More instructions can be
found in Section 4. How do I use Lenalidomide-Teva? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LENALIDOMIDE-TEVA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Lenalidomide-Teva.
•
FEMALE PATIENTS:
Tell your doctor immediately if you become pregnant or suspect that
you may be pregnant. You should
also immediately stop taking Lenalidomide-Teva in

Ficha técnica

1
Lenalidomide-Teva
(lenalidomide) capsules version 3.0
AUSTRALIAN PRODUCT INFORMATION
LENALIDOMIDE-TEVA
(LENALIDOMIDE) CAPSULES
1.
NAME OF THE MEDICINE
Lenalidomide (as lenalidomide hydrochloride monohydrate)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 mg capsule contains 2.5 mg of lenalidomide (as hydrochloride
monohydrate).
Each 5 mg capsule contains 5 mg of lenalidomide (as hydrochloride
monohydrate).
Each 7.5 mg capsule contains 7.5 mg of lenalidomide (as hydrochloride
monohydrate).
Each 10 mg capsule contains 10 mg of lenalidomide (as hydrochloride
monohydrate).
Each 15 mg capsule contains 15 mg of lenalidomide (as hydrochloride
monohydrate).
Each 20 mg capsule contains 20 mg of lenalidomide (as hydrochloride
monohydrate).
Each 25 mg capsule contains 25 mg of lenalidomide (as hydrochloride
monohydrate)
.
For the full list of excipients, see Section 6.1 (List of excipients).
3.
PHARMACEUTICAL FORM
Lenalidomide 2.5 mg capsules: hard, non-transparent capsules with
black mark 2.5 on white body
and with green cap.
Lenalidomide 5 mg capsules: hard, non-transparent capsules with black
mark 5 on white body and
with white cap.
Lenalidomide 7.5 mg capsules: hard, non-transparent capsules with
black mark 7.5 on white body
and with ivory cap.
Lenalidomide 10 mg capsules: hard, non-transparent capsules with black
mark 10 on ivory body
and with green cap.
Lenalidomide 15 mg capsules: hard, non-transparent capsules with black
mark 15 on white body
and with blue cap.
Lenalidomide 20 mg capsules: hard, non-transparent capsules with black
mark 20 on blue body and with
green cap.
Lenalidomide 25 mg capsules: hard, non-transparent capsules with black
mark 25 on white body and
with white cap.
DO NOT USE LENALIDOMIDE DURING PREGNANCY.
TERATOGENIC EFFECTS: LENALIDOMIDE IS STRUCTURALLY RELATED TO
THALIDOMIDE. THALIDOMIDE IS A KNOWN
HUMAN TERATOGEN THAT CAUSES SEVERE LIFE-THREATENING HUMAN BIRTH
DEFECTS. IF LENALIDOMIDE IS TAKEN
DURING PREGNANCY, IT MAY CAUSE BIRTH DEFECTS OR DEATH TO AN UNBORN
BABY. WOMEN SHOULD BE
ADVISE