Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fluorouracil sodium
Accord-UK Ltd
L01BC02
Fluorouracil sodium
50mg/1ml
Solution for injection
Intravenous; Intraarterial
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010300; GTIN: 5060149312155
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FLUOROURACIL 50 MG/ML SOLUTION FOR INJECTION OR 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 or 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 this leaflet. See Section 4. WHAT IS IN THIS LEAFLET 1. What Fluorouracil Injection is and what it is used for 2. What you need to know before you use Fluorouracil Injection 3. How to use Fluorouracil Injection 4. Possible side effects 5. How to store Fluorouracil Injection 6. Contents of the pack and other information 1. WHAT FLUOROURACIL INJECTION IS AND WHAT IT IS USED FOR The name of your medicine is ‘ Fluorouracil 50 mg/ml, Solution for Injection or Infusion’ but in the rest of the leaflet it will be called ‘Fluorouracil Injection’. WHAT FLUOROURACIL INJECTION IS Fluorouracil Injection contains the active ingredient Fluorouracil. It is an anti-cancer medication. WHAT FLUOROURACIL INJECTION IS USED FOR Fluorouracil Injection 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 INJECTION DO NOT USE FLUOROURACIL INJECTION if you are allergic (hypersensitive) to Fluorouracil or any of the other ingredients of Fluorouracil Injection (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 d Lire le document complet
OBJECT 1 FLUOROURACIL 50 MG/ML SOLUTION FOR INJECTION OR INFUSION Summary of Product Characteristics Updated 27-Apr-2016 | Accord Healthcare Limited 1. Name of the medicinal product Fluorouracil 50 mg/ml Solution for Injection or Infusion 2. Qualitative and quantitative composition 1 ml of solution contains 50 mg of fluorouracil (as sodium salt formed _in situ_). Each 5 ml vial contains 250 mg of fluorouracil. Each 10 ml vial contains 500 mg of fluorouracil. Each 20 ml vial contains 1000 mg of fluorouracil. Each 50 ml vial contains 2500 mg of fluorouracil. Each 100 ml vial contains 5000 mg of fluorouracil. Excipients with known effect: 8.25 mg/ml (0.360 mmol/ml) sodium For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for Injection or Infusion. A clear colourless solution with a pH in the range of 8.6 to 9.4. 4. Clinical particulars 4.1 Therapeutic indications Fluorouracil is indicated in adults. Fluorouracil 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 4.2 Posology and method of administration Posology 5-fluorouracil 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. Method of administration 5- Lire le document complet