FLUOROURACIL Solution for injection or infusion (2019)

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Περιεχόμενα

Name of the medicinal product

Fluorouracil 50 mg/ml Solution for Injection or Infusion.

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 ...

Pharmaceutical form

Solution for Injection or Infusion. A clear colourless solution with a pH in the range of 8.6 to 9.4.

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 ...

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 ...

Contraindications

Hypersensitivity to the fluorouracil or to any of the excipients listed in section 6.1. Fluorouracil is contraindicated in the following Serious infections (e.g. Herpes zoster, chickenpox). Seriously debilitated ...

Special warnings and precautions for use

It is recommended that fluorouracil should only be given by, or under the strict supervision of, a qualified physician who is conversant with the use of potent antimetabolites and has the facilities for ...

Interaction with other medicinal products and other forms of interaction

Various agents have been reported to biochemically modulate the anti-tumour efficacy or toxicity of Fluorouracil. Common drugs include methotrexate, metronidazole, leucovorin interferon alfa and allopurinol. ...

Pregnancy and lactation

Pregnancy There are no adequate and well-controlled studies in pregnant women, however, fetal defects and miscarriages have been reported. Women of childbearing potential should be advised to avoid becoming ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machinery have been performed. Fluorouracil may induce side effects such as nausea and vomiting. It can also produce adverse event on nervous system ...

Undesirable effects

Frequencies are defined using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10000 to <1/1000), Very rare (<1/10000), Not known (cannot ...

Overdose

The symptoms and signs of overdosage are qualitatively similar to the adverse reactions but commonly are more pronounced particularly, the following adverse reactions might occur: Nausea, vomiting, diarrhoea, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents; Antimetabolites; Pyrimidine analogues ATC code: L01BC02 Mechanism of action Fluorouracil is an analogue of uracil, a component of ribonucleic acid. The ...

Pharmacokinetic properties

After intravenous administration, Fluorouracil is distributed through the body water and disappears from the blood within 3 hours. It is preferentially taken up by actively dividing tissues and tumours ...

Preclinical safety data

Preclinical information has not been included, as the clinical toxicity profile of fluorouracil has been established after many years of clinical use.

List of excipients

Sodium hydroxide (For pH adjustment) Hydrochloric acid (For pH adjustment) Water for Injections

Incompatibilities

Fluorouracil is incompatible with folinic acid, Carboplatin, Cisplatin, Cytarabine, Diazepam, Doxorubicin, Droperidol, Filgrastim, Gallium nitrate, Methotrexate, Metoclopramide, Morphine, Ondansetrone, ...

Shelf life

Shelf life of unopened vial: 2 years. Vial after first opening: Use immidiately after opening Shelf Life after dilution: In use: Chemical and physical in-use stability has been demonstrated ...

Special precautions for storage

Store below 25°C. Do not refrigerate or freeze. Keep vial in the outer carton in order to protect from light. The pH of Fluorouracil Injection is 8.9 and the drug has maximal stability over the pH range ...

Nature and contents of container

Fluorouracil Injection 50 mg/ml, 5 ml is filled in 5 ml Type I clear glass vials with rubber closure. Fluorouracil Injection 50 mg/ml, 10 ml is filled in 10 ml Type I clear glass vials with rubber closure. ...

Special precautions for disposal and other handling

Cytotoxic Handling Guidelines Fluorouracil should be administered only by or under the supervision of a qualified physician who is experienced in the use of cancer chemotherapeutic drugs. Fluorouracil ...

Marketing authorization holder

Accord Healthcare Limited, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Marketing authorization number(s)

PL 20075/0078

Date of first authorization / renewal of the authorization

10/06/2009 / 28/04/2014

Date of revision of the text

08/04/2019

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