Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Epirubicin hydrochloride
Pfizer Ltd
L01DB03
Epirubicin hydrochloride
2mg/1ml
Solution for injection
Intravenous; Intravesical
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010200; GTIN: 5013457026672
Page 1 of 16 PATIENT LEAFLET: INFORMATION FOR THE USER PHARMORUBICIN® 2 MG/ML SOLUTION FOR INJECTION OR INFUSION Epirubicin 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, please ask your doctor, pharmacist or nurse. • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. WHAT PHARMORUBICIN IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USEPHARMORUBICIN 3. HOW TO USE PHARMORUBICIN 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE PHARMORUBICIN 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT PHARMORUBICIN IS AND WHAT IT IS USED FOR • Pharmorubicin is an injection that contains epirubicin hydrochloride. It belongs to a group of medicines called cytotoxics used for chemotherapy. Pharmorubicin causes cells that are actively growing, such as cancer cells, to slow or stop their growth and increases the likelihood that they die. This medicine helps to selectively kill the cancer tissue rather than normal, healthy tissue. • Pharmorubicin is used to treat a variety of cancers, either alone or in combination with other drugs. The way in which it is used depends upon the type of cancer that is being treated. • It has been found to be particularly useful in the treatment of cancers of the breast, ovaries, stomach, bowel and lung. In addition, this medicine can be given to treat cancers of the blood forming tissues such as malignant lymphomas, leukaemias and multiple myeloma. • Pharmorubicin can also be put directly into the bladder through a tube. This is sometimes used to treat abnormal cells or cancers of the bladder wall. It can be used after Read the complete document
OBJECT 1 PHARMORUBICIN Summary of Product Characteristics Updated 05-Sep-2016 | Pfizer Limited 1. Name of the medicinal product Pharmorubicin 2 mg/ml Solution for Injection 2. Qualitative and quantitative composition Epirubicin hydrochloride 2 mg per ml 5 ml vials contain 10 mg of epirubicin hydrochloride 10 ml vials contain 20 mg of epirubicin hydrochloride 25 ml vials contain 50 mg of epirubicin hydrochloride 100 ml vials contain 200 mg epirubicin hydrochloride. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection or infusion. Red, sterile, preservative-free, aqueous solution. 4. Clinical particulars 4.1 Therapeutic indications Pharmorubicin has produced responses in a wide range of neoplastic conditions, including breast, ovarian, gastric, lung and colorectal carcinomas, malignant lymphomas, leukaemias and multiple myeloma. Intravesical administration of Pharmorubicin has been found to be beneficial in the treatment of superficial bladder cancer, carcinoma-in-situ and in the prophylaxis of recurrences after transurethral resection. 4.2 Posology and method of administration Pharmorubicin is not active when given orally and should not be injected intramuscularly or intrathecally. It is advisable to give the drug via the tubing of a freely-running IV saline infusion after checking that the needle is well placed in the vein. This method minimises the risk of drug extravasation and makes sure that the vein is flushed with saline after the administration of the drug. Extravasation of Pharmorubicin from the vein during injection may give rise to severe tissue lesions, even necrosis. Venous sclerosis may result from injection into small vessels or repeated injections into the same vein. _Conventional doses:_ When Pharmorubicin is used as a single agent, the recommended dosage in adults is 60-90 mg/m 2 body area; the drug should be injected I.V. over 3-5 minutes and, depending on the patient's haematomedullary status, the dose should be repeated at 21-day intervals. _High dose Read the complete document