Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
DOXORUBICIN HYDROCHLORIDE
Seacross Pharma (Europe) Limited
L01DB; L01DB01
DOXORUBICIN HYDROCHLORIDE
2 milligram(s)/millilitre
Concentrate for solution for infusion
Anthracyclines and related substances; doxorubicin
Not marketed
2010-01-29
_uk/ie-pl-clean-v11.1-20230209 _ _1 of 7_ PACKAGE LEAFLET: INFORMATION FOR THE USER DOXORUBICIN 2MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION REFERRED TO IN THIS LEAFLET AS DOXORUBICIN 2MG/ML DOXORUBICIN HYDROCHLORIDE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Doxorubicin 2 mg/ml is and what it is used for 2. Before you use Doxorubicin 2 mg/ml 3. How to use Doxorubicin 2 mg/ml 4. Possible side effects 5. How to store Doxorubicin 2 mg/ml 6. Further information 1. WHAT DOXORUBICIN 2MG/ML IS AND WHAT IT IS USED FOR Doxorubicin, the active ingredient in Doxorubicin 2 mg/ml, is a medicine that kills cancer cells. It is used to treat several types of cancer, e.g., breast cancer, lung cancer, leukaemia (cancer of the blood or bone marrow), tumours of the thyroid gland, bladder and ovaries, and paediatric malignancy. Doxorubicin 2 mg/ml is frequently used in combination with other anti-cancer treatments. 2. BEFORE YOU USE DOXORUBICIN 2 MG/ML DO NOT USE DOXORUBICIN 2 MG/ML - if you are hypersensitive (allergic) to doxorubicin or any of the other ingredients of Doxorubicin 2 mg/ml, or to other anthracyclines or anthracenediones (anti-cancer medicines) - if you are pregnant or breastfeeding _ _ INTRAVENOUS MEDICATION MUST NOT BE USED IF: - you have decreased bone marrow function or if severe oral mucositis (inflammation of the mouth) has occurred during previous cytotoxic therapy - you have a generalised infection - you have severe hepatic impairment (liver damage) - you have severe arrhythmia (irregular heart beat), cardiac impairment (problems with your heart function) or yo Прочитајте комплетан документ
Health Products Regulatory Authority 01 February 2023 CRN00DDLJ Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Doxorubicin 2mg/ml Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Doxorubicin hydrochloride 1ml contains 2 mg Doxorubicin hydrochloride. Each 5ml vial contains 10 mg of Doxorubicin hydrochloride. Each 10ml vial contains 20 mg of Doxorubicin hydrochloride. Each 25ml vial contains 50 mg of Doxorubicin hydrochloride. Each 50ml vial contains 100 mg of Doxorubicin hydrochloride. Each 100ml vial contains 200 mg of Doxorubicin hydrochloride. Excipients: The product contains sodium chloride (3.54 mg sodium per 1 ml). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion Red concentrate for infusion. 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 neuroblastoma. Doxorubicin is frequently used in combination chemotherapy regimens with other cytotoxic drugs. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Doxorubicin should be started by or after consulation with a doctor with extensive experience from cytostatic treatment. The concentrate is injected via the tubing of a freely-running intravenous infusion (Sodium chloride 0.9% intravenous infusion or Dextrose 5% 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 pat Прочитајте комплетан документ