Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
PHENYTOIN SODIUM
Mercury Pharmaceuticals (Ireland) Ltd
N03AB02
PHENYTOIN SODIUM
250 MG/5ml
Solution for Injection
Product subject to prescription which may not be renewed (A)
Hydantoin derivatives
Authorised
1992-03-23
PACKAGE LEAFLET: INFORMATION FOR THE USER PHENYTOIN SODIUM 250MG/5ML SOLUTION FOR INJECTION 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. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. This product will be referred to as Phenytoin Injection from here on. WHAT IS IN THIS LEAFLET: 1. What Phenytoin Injection is and what it is used for 2. What you need to know before you use Phenytoin Injection 3. How to use Phenytoin Injection 4. Possible side effects 5. How to store Phenytoin Injection 6. Contents of the pack and other information 1. WHAT PHENYTOIN INJECTION IS AND WHAT IT IS USED FOR Phenytoin belongs to a group of medicines called anti-epileptic drugs. Phenytoin injection is used to treat: • severe epileptic seizures or fits (status epilepticus) • and control the condition in which seizures occur continuously • or prevent seizures during or after brain surgery • specific changes in the rhythm of the heart (cardiac arrhythmias), particularly when these are caused by the digitalis drugs such as digoxin. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PHENYTOIN INJECTION DO NOT USE PHENYTOIN INJECTION IF: • you know that you are allergic (hypersensitive) to Phenytoin Sodium or other hydantoins or any of the other ingredients listed in Section 6 of this leaflet • you have a slow heart beat or any heart problems that interfere with the rate at which your heart beats • you suffer from sudden fainting with occasional fits. WARNINGS AND PRECAUTIONS: Talk to your doctor, pharmacist or nurse before using Phenytoin Injection if: • you have low blood press Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Phenytoin Sodium 250 mg/5 ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of solution contains 250 mg of Phenytoin Sodium. Each 1 ml of solution contains 50 mg of Phenytoin Sodium. Excipients with known effect: Sodium (23 mg per 5 ml solution) Ethanol (395 mg per 5 ml solution) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection A clear, colourless, sterile solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Phenytoin Sodium 250mg/5ml Solution for Injection is indicated for the control of status epilepticus and other persistent convulsive disorders; for the prophylactic control of seizures in neurosurgery. It is also indicated in the treatment of cardiac arrhythmias when these are digitalis induced. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults: Status epilepticus: a loading dose of Phenytoin 10-15mg/kg (150 to 250 mg) should be injected slowly intravenously, at a rate not exceeding 50mg per minute to avoid hypotension (this will require approximately 20 minutes in a 70Kg patient). This dose can be repeated if necessary after 30 minutes. The loading dose should be followed by maintenance doses of 100mg orally or intravenously every 6 to 8 hours. This drug must be administered slowly. In adults, intravenous administration should not exceed a rate of 50mg per minute. Use in cardiac arrhythmias: 3.5 - 5mg per kg of bodyweight intravenously initially, repeated once if necessary. The solution should be injected slowly, and at a uniform rate which should not exceed 50mg per minute. Neurosurgery: In a patient who has not previously received the drug, Phenytoin Sodium 250mg/5ml Solution for Injection 100-200mg (2-4ml) Lire le document complet