País: Malta
Língua: inglês
Origem: Medicines Authority
DOXORUBICIN HYDROCHLORIDE
Mylan S.A.S. 117 Allee des Parcs, 69800 Saint Priest, France
L01DB01
DOXORUBICIN HYDROCHLORIDE 2 mg
CONCENTRATE FOR SOLUTION FOR INFUSION
DOXORUBICIN HYDROCHLORIDE 2 mg
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2015-02-18
1 PACKAGE LEAFLET: INFORMATION FOR THE USER DOXORUBICIN MYLAN 2 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Doxorubicin hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Doxorubicin Mylan is and what it is used for 2. What you need to know before you receive Doxorubicin Mylan 3. How Doxorubicin Mylan is administered 4. Possible side effects 5. How to store Doxorubicin Mylan 6. Contents of the pack and other information 1. WHAT DOXORUBICIN MYLAN IS AND WHAT IT IS USED FOR Doxorubicin Mylan belongs to a group of anti-cancer medicines called anthracyclines. Doxorubicin Mylan_ _is used to treat the following types of cancer: - Small cell lung cancer - Bladder cancer - Bone cancer - Breast cancer - Cancer of the blood - Cancer in the lymph system (Hodgkin and Non-Hodgkin’s lymphoma) - Cancer of the bone marrow - Cancer in the thyroid gland - Cancer in soft tissue (in adult age) - Recurrent cancer in the ovaries - Advanced or recurrent cancer in the mucous membrane lining the uterus - Certain type of kidney cancer that affects children (Wilm´s tumour) - Certain type of advanced cancer in nerve cells that affects children (neuroblastoma) Doxorubicin Mylan is also used in combination with other anti-cancer drugs. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DOXORUBICIN MYLAN YOU MUST NOT RECEIVE Doxorubicin Mylan - if you are allergic to doxorubicin or any of the other ingredients of this medicine (listed in section 6); - if you are allergic to drugs of the class anthracyclines or anthracendiones; - if you are breastfeeding. Please talk to your doctor in case any of the above applies to you. YOU MUST NOT RECEIVE DOXORUBICIN MYLAN INTRAVENOUSLY - if yo Leia o documento completo
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Doxorubicin Mylan 2 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of Doxorubicin Mylan 2 mg/ml contains 2 mg doxorubicin hydrochloride 5 ml of Doxorubicin Mylan 2 mg/ml contains 10 mg doxorubicin hydrochloride 10 ml of Doxorubicin Mylan 2 mg/ml contains 20 mg doxorubicin hydrochloride 25 ml of Doxorubicin Mylan 2 mg/ml contains 50 mg doxorubicin hydrochloride 100 ml of Doxorubicin Mylan 2 mg/ml contains 200 mg doxorubicin hydrochloride Excipients with known effect: Sodium 3,54 mg per ml concentrate (0,154 mmol/l) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, red orange solution. pH = 2.5 – 3.5 The osmolarity of the solution is between 240 and 370 mOsmol/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Small-cell lung cancer (SCLC) - Breast cancer - Recurrent ovarian carcinoma - Intravesical prophylaxis of recurrences of superficial bladder carcinoma following transurethral resection (TUR) - Systemic treatment of local advanced or metastasized bladder carcinoma - Neoadjuvant and adjuvant therapy of osteosarcoma - Advanced soft-tissue sarcoma in adults - Ewing’s sarcoma - Hodgkin’s lymphoma - Highly malignant non-Hodgkin’s lymphoma - Induction and consolidation therapy in acute lymphatic leukaemia - Acute myeloblastic leukaemia - Advanced multiple myeloma - Advanced or recurrent endometrial carcinoma - Wilms’ tumour (in stage II in highly malignant variants, all advanced stages [III – IV]) - Advanced papillary/follicular thyroid cancer - Anaplastic thyroid cancer - Advanced neuroblastoma Doxorubicin is frequently used in combination chemotherapy regimens with other cytotoxic drugs. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Doxorubicin Mylan should be administered only under the supervision of a qualified physician with extensive experience in cytotoxic therapy. Also, patients must be carefully and frequently Leia o documento completo