Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Fomepizole sulphate
SERB S.A.,
V03AB; V03AB34
Fomepizole sulphate
5 milligram(s)/millilitre
Concentrate for solution for infusion
Antidotes; fomepizole
Marketed
2002-10-11
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FOMEPIZOLE SERB 5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Fomepizole (as sulphate) 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. • 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. This include any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What FOMEPIZOLE SERB is and what it is used for 2. What you need to know before you use FOMEPIZOLE SERB 3. How to use FOMEPIZOLE SERB 4. Possible side effects 5. How to store FOMEPIZOLE SERB 6. Contents of the pack and other information 1. WHAT FOMEPIZOLE SERB IS AND WHAT IT IS USED FOR FOMEPIZOLE SERB 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 SERB halts the progression of ethylene glycol poisoning and allows removal of ethylene glycol from blood. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FOMEPIZOLE SERB DO NOT USE FOMEPIZOLE SERB • If you are allergic to fomepizole or any of the other ingredients of this medicine (listed in 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. WARNINGS AND PRECAUTIONS TAKE SPECIAL CARE WITH FOMEPIZOLE SERB • 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 mo Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 01 December 2022 CRN00D90X Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fomepizole SERB 5 mg/mL, concentrate for solution for infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 8 mg of fomepizole sulphate equivalent to 5 mg fomepizole. An ampoule of 20 ml contains 160 mg fomepizole sulphate, equivalent to 100 mg fomepizole; Excipient(s) with known effect: An ampoule of 20 ml contains 2,4 mmol sodium For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Fomepizole SERB is a clear and colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fomepizole SERBis an antidote used in the treatment of acute ethylene glycol poisoning. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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_._ 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 mmol/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 hours until ethylene glycol levels has been reduced below 0.2 g/l (3.2 mmol/l). _Fomepizole dose (mg/kg body we Lesen Sie das vollständige Dokument