Страна: Мальта
Язык: английский
Источник: Malta Medicines Authority
FLUOROURACIL
Mylan S.A.S. 117 Allee des Parcs, 69800 Saint Priest, France
L01BC02
FLUOROURACIL 50 mg/ml
SOLUTION FOR INFUSION OR INJECTION
FLUOROURACIL 50 mg/ml
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2014-07-02
Page 1 of 12 PACKAGE LEAFLET: INFORMATION FOR THE USER FLUOROURACIL MYLAN 50 MG/ML SOLUTION FOR INJECTION/INFUSION Fluorouracil 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, 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 or pharmacist or nurse. This includes any possible side effects not listed in thisleaflet. See Section 4. WHAT IS IN THIS LEAFLET 1. What Fluorouracil Mylan is and what it is used for 2. What you need to know before you use Fluorouracil Mylan 3. How to use Fluorouracil Mylan 4. Possible side effects 5. How to store Fluorouracil Mylan 6. Contents of the pack and other information 1. WHAT FLUOROURACIL MYLAN IS AND WHAT IT IS USED FOR Fluorouracil Mylan contains the active ingredient fluorouracil. It is an anti-cancer medicine. This medicine is used to treat many common cancers, particularly cancers of the large bowel, oesophagus, pancreas, stomach, head and neck and breast. It may be used in combination with other anti-cancer medicines and radiotherapy. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLUOROURACIL MYLAN DO NOT USE FLUOROURACIL MYLAN if you are allergic to fluorouracil or any of the other ingredients of this medicine (listed in section 6). if you have serious infections (e.g. Herpes zoster, chickenpox) if your tumour is non-malignant. if you have been very much weakened by long illness. if your bone marrow has been damaged by other treatments (including radiotherapy). if you are taking brivudin, sorivudin and analogues (an antiviral medicine) if you are pregnant or breast feeding women if you have serious impaired liver function if you are homozygotic for dihydropyrimidine dehydrogenase (DPD) enzy Прочитать полный документ
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fluorouracil Mylan 50 mg/ml solution for injection/infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains 50 mg of fluorouracil. Each 10 ml vial contains 500 mg of fluorouracil. Each 20 ml vial contains 1 g of fluorouracil. Each 50 ml vial contains 2.5g of fluorouracil. Each 100 ml vial contains 5 g of fluorouracil. Each ml of solution for injection/infusion contains approximately 0.34 to 0.39mmol / ml (or 7.9–9.0 mg/ml) of sodium in the form of Sodium Hydroxide. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection/infusion. Clear colourless to yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fluorouracil Mylan is indicated in the treatment of the following malignancies and disease settings: - in the treatment of metastatic colorectal cancer - as adjuvant treatment in colon and rectal cancer - in the treatment of advanced gastric cancer, - in the treatment of advanced pancreatic cancer, - in the treatment of advanced oesophageal cancer, - in the treatment of advanced or metastatic breast cancer, - as adjuvant treatment in patients with operable primary invasive breast cancer, - in the treatment of inoperable locally advanced squamous cell carcinoma of the head and neck in previously untreated patients - in the treatment of locally recurrent or metastatic squamous cell carcinoma of the head and neck Page 2 of 15 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Fluorouracil Mylan should be administered only under the supervision of a qualified physician with extensive experience in cytotoxic treatment. Patients must be carefully and frequently monitored during the treatment. The risks and benefits to individual patients should be carefully considered before each treatment. Fluorouracil Mylan can be administered by intravenous injection as bolus, infusion or continuous infusion for up to several days. “These are general advices. Please refer to a local or Прочитать полный документ