מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
lenalidomide hydrochloride monohydrate, Quantity: 6.05 mg
Teva Pharma Australia Pty Ltd
Capsule
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
Oral
21, 28, 14
(S4) Prescription Only Medicine
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.
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
Registered
2021-06-16
LENALIDOMIDE-TEVA ® L e n a l i d o m i d e - T e v a ® v 3 . 0 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 קרא את המסמך השלם
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 קרא את המסמך השלם