देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
FOMEPIZOLE SULPHATE
EUSA Pharma (UK) Limited
V03AB34
FOMEPIZOLE SULPHATE
5 Mg/Ml
Concentrate for Soln for Inf
Product subject to prescription which may not be renewed (A)
fomepizole
Marketed
2002-10-11
1 FOMEPIZOLE EUSA PHARMA 5 MG/ML, CONCENTRATE FOR SOLUTION FOR INFUSION Fomepizole (as sulphate) 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. 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. IN THIS LEAFLET: 1. What FOMEPIZOLE EUSA Pharma is and what it is used for 2. Before you use FOMEPIZOLE EUSA Pharma 3. How to use FOMEPIZOLE EUSA Pharma 4. Possible side effects 5. How to store FOMEPIZOLE EUSA Pharma 6. Further information 7. Practical information for medical and healthcare professionals 1. WHAT FOMEPIZOLE EUSA PHARMA IS AND WHAT IT IS USED FOR FOMEPIZOLE EUSA Pharma is an antidote. It is used as an emergency treatment for oral ethylene glycol poisoning. Your doctor has prescribed you this medicine because you have ingested a toxic substance called ethylene glycol (clear, colorless, odorless liquid with a sweet taste, widely used as an automotive antifreeze). FOMEPIZOLE EUSA Pharma halts the progression of ethylene glycol poisoning and allows removal of ethylene glycol from blood. 2. BEFORE YOU USE FOMEPIZOLE EUSA PHARMA DO NOT USE FOMEPIZOLE EUSA PHARMA • If you are allergic (hypersensitive) to the active substance (fomepizole) or any of the other ingredients of FOMEPIZOLE EUSA Pharma (see section 6). • If you are allergic to other medicines belonging to the same family (pyrazoles). In such case, you may also be allergic to fomepizole. TAKE SPECIAL CARE WITH FOMEPIZOLE EUSA PHARMA • If you experience: - a sudden swelling of the throat, face, lips or mouth, - redness, skin rush or itching. It is an allergic reaction. In this case, your doctor will monitor the observed signs. If your allergic reaction becomes more important or gets worse, you should पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fomepizole EUSA Pharma 5 mg/mL, concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 8 mg fomepizole sulphate, equivalent to 5 mg fomepizole. An ampoule of 20 ml contains 160 mg fomepizole sulphate, equivalent to 100 mg fomepizole. Excipients: An ampoule of 20 ml contains 2.4 mmol sodium. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion Fomepizole EUSA Pharma is a clear and colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fomepizole EUSA Pharma is an antidote used in the treatment of acute ethylene glycol poisoning. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The treatment should begin whenever ethylene glycol poisoning is suspected, as early as possible after its ingestion, even in the absence of signs of toxicity. In the absence of ethylene glycol assay, ethylene glycol poisoning should be suspected on the following criteria: - patient’s history ; - osmolar gap > 20 mOsm/kg H 2 0 ; - metabolic acidosis with anion gap > 16 mmol/l (presence of high levels of glycolates) ; - calcium oxalate crystals in the urine. An assay for plasma ethylene glycol should be performed at admission, but this determination should not delay start of treatment with fomepizole. Plasma ethylene glycol levels should be monitored every 12 to 24 hours_._ Fomepizole EUSA Pharma 5mg/mL, concentrate for solution for infusion, is to be diluted before use (see section 6.6). The diluted solution should be administered by slow intravenous infusion. Dosage depends on plasma ethylene glycol concentration and renal function: - patients with normal renal or mild to moderate impaired renal function as assessed by serum creatinine (100 to 265 µmol/l) in whom hemodialysis is not required : Administration should be performed by slow intravenous infusion, over 30 to 45 minutes, given as follows: infusion of a loading dose of 15 mg/kg followed by doses every 12 hour पूरा दस्तावेज़ पढ़ें