Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
DOXORUBICIN HYDROCHLORIDE
Cell Pharm GmbH
L01DB; L01DB01
DOXORUBICIN HYDROCHLORIDE
2 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Anthracyclines and related substances; doxorubicin
Not marketed
2004-03-19
1 PACKAGE LEAFLET: INFORMATION FOR THE USER DOXORUBICIN 2 MG/ML SOLUTION FOR INJECTION Doxorubicin hydrochloride 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 effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Doxorubicin 2 mg/ml Solution for Injection is and what it is used for 2. What you need to know before you use Doxorubicin 2 mg/ml Solution for Injection 3. How to use Doxorubicin 2 mg/ml Solution for Injection 4. Possible side effects 5. How to store Doxorubicin 2 mg/ml Solution for Injection 6. Contents of the pack and other information 1. WHAT DOXORUBICIN 2 MG/ML SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR Doxorubicin 2 mg/ml Solution for Injection is an anti-cancer medicine. Often, Doxorubicin 2 mg/ml Solution for Injection is used in combination with other anti-cancer medicines. Doxorubicin 2 mg/ml Solution for Injection is used to treat the following forms of cancer: - breast cancer - cancer of the connective tissue, ligaments, bone, muscle (sarcoma ) - lung cancer - cancer of the lymphnodes (Hodgkin’s disease or non-Hodgkin’s lymphoma ) - blood cancer (acute leukaemia) - cancer of the thyroid gland - cancer of the ovaries - bladder cancer - tumours in children such as neuroblastoma 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DOXORUBICIN 2 MG/ML SOLUTION FOR INJECTION DO NOT USE DOXORUBICIN 2 MG/ML SOLUTION FOR INJECTION - if you are allergic to doxorubicin, other medicines of the anthracycline or anthracenedione groups (e. g. daunorubicin, mitoxantrone and epirubicin) or any of the other ingredients of this medicine (list Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Doxorubicin 2 mg/ml solution for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 2 mg doxorubicin hydrochloride. Excipient with know effect: 9 mg/ml sodium chloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection Clear red solution for injection. pH = 2.5 – 3.5 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Breast cancer, sarcoma, small-cell carcinoma of the lung, Hodgkin disease or non-Hodgkin lymphoma, acute leukaemia, cancer of the thyroid, bladder, ovaries, Paediatric tumours, such as neuroblastom. Doxorubicin is frequently used in combination chemotherapy regimens with other cytotoxic drugs. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Doxorubicin 2 mg/ml solution for injection should be started by or after consultation with a doctor with extensive experience from cytostatic treatment. The solution is injected via the tubing of a freely-running intravenous infusion over 2-15 minutes. This technique minimizes the risk of thrombophlebitis or perivenous extravasation which can lead to severe cellulitis and vesication. Intravenous administration: The dosage of doxorubicin depends on dosage regimen, general status and previous treatment of the patient. Several dosage regimens exist: The recommended dose is 60-75 mg/m² body surface i.v. as a single dose or in divided doses on 2-3 consecutive days administered with 21 day’s intervals. The lower dose should be given to patients with bone marrow depression. When Doxorubicin 2 mg/ml solution for injection is administered in combination with other cytostatics, the dosage should be reduced to 30-60 mg/m². In patients, who cannot receive the full dose (eg. in case of immunosuppression, old age), an alternative dosage is 15- 20 mg/m² body surface per week_._ In order to avoid cardiomyopathy, it is recommended that the cumulative total lifetime dose of doxorubicin (including related drugs such as daunorubicin) should Perskaitykite visą dokumentą