מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
DOXORUBICIN HYDROCHLORIDE
Accord Healthcare Ireland Ltd.
L01DB; L01DB01
DOXORUBICIN HYDROCHLORIDE
2 milligram(s)/millilitre
Concentrate for solution for infusion
Anthracyclines and related substances; doxorubicin
Not marketed
2010-07-09
NL/H/4562/001/II/034, Version 01, DEC 2023 PACKAGE LEAFLET: INFORMATION FOR THE USER DOXORUBICIN 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. • 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 Doxorubicin concentrate for solution for infusion is and what it is used for 2. What you need to know before you use Doxorubicin concentrate for solution for infusion 3. How to use Doxorubicin concentrate for solution for infusion 4. Possible side effects 5. How to store Doxorubicin concentrate for solution for infusion 6. Contents of the pack and other information 1. WHAT DOXORUBICIN CONCENTRATE FOR SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR The name of your medicine is “Doxorubicin 2 mg/ml Concentrate for Solution for Infusion” but in the rest of the leaflet it will be called ‘Doxorubicin concentrate for solution for infusion’. Doxorubicin is one of a group of medicines called the anthracyclines. These drugs are also known as cancer drugs, chemotherapy, or "chemo". They are used in the treatment of various cancers to slow or stop the growth of cancer cells. A combination of different types of cancer drugs will often be used to achieve better results and minimize side effects. Doxorubicin concentrate for solution for infusion is used to treat the following forms of cancer: • breast cancer • cancer of the connective tissue, ligaments, bone, muscle (sarcoma) • cancer develops within the stomach or intestine • lung cancer • lymphomas, a cancer affecting קרא את המסמך השלם
Health Products Regulatory Authority 20 February 2024 CRN00F4MM Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Doxorubicin 2 mg/ml Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 2 mg Doxorubicin hydrochloride. Each 5 ml vial contains 10 mg of Doxorubicin hydrochloride. Each 10 ml vial contains 20 mg of Doxorubicin hydrochloride. Each 25 ml vial contains 50 mg of Doxorubicin hydrochloride. Each 50 ml vial contains 100 mg of Doxorubicin hydrochloride Each 100 ml vial contains 200 mg of Doxorubicin hydrochloride. EXCIPIENT(s) with known effect: Contains sodium 3.5 mg/ml (0.15 mmol) For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. The product is a clear, red solution, with a pH in the range of 2.5-3.5 and osmolality between 270 mOsm/kg to 320 mOsm/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Doxorubicin is indicated in the following neoplastic conditions. Examples include: Small-cell lung cancer (SCLC) Breast cancer Advanced ovarian carcinoma Intravesically for bladder cancer Neoadjuvant and adjuvant therapy of osteosarcoma Advanced soft-tissue sarcoma in adults Ewing's sarcoma Hodgkin's disease Non-Hodgkin's lymphoma Acute lymphatic leukaemia Acute myeloblastic leukaemia Advanced multiple myeloma Advanced or recurrent endometrial carcinoma Wilms' tumour Advanced papillary/follicular thyroid cancer Anaplastic thyroid cancer Advanced neuroblastoma Doxorubicin is frequently used in combination chemotherapy regimens with other cytotoxic drugs. Health Products Regulatory Authority 20 February 2024 CRN00F4MM Page 2 of 15 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Doxorubicin Injection should be administered only under the supervision of a qualified physician with extensive experience in cytotoxic treatment. Also, patients must be carefully and frequently monitored during the treatment (see section 4.4) Due to קרא את המסמך השלם