দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
PHENYTOIN SODIUM
Accord Healthcare Limited
N03AB02
PHENYTOIN SODIUM
250mg/5ml Mg/Ml
Solution for Inj/Inf
Product subject to prescription which may not be renewed (A)
phenytoin
Authorised
2017-10-13
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PHENYTOIN 250 MG/5 ML SOLUTION FOR INJECTION OR INFUSION Phenytoin sodium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, 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. This includes any possible side effects not listed in this leaflet. See section 4. - You may have been given Phenytoin injection as a single dose to control seizures in an emergency (status epilepticus). In this case, you will only be able to read this leaflet after you have had the product given to you. Your doctor will have considered the important safety information in this leaflet, but your urgent need for treatment may have been more important than some of the normal cautions. Check them now, especially if you are going to continue to be given Phenytoin injection (or any other form of phenytoin). WHAT IS IN THIS LEAFLET: 1. What Phenytoin injection is and what it is used for 2. What you need to know before you are given Phenytoin injection 3. How Phenytoin injection is given 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 This medicine is a solution for injection or infusion containing phenytoin, which belongs to a group of medicines called antiepileptic medicines. Phenytoin injection can be used to treat severe epileptic seizures or fits (status epilepticus). It can also be used to control or prevent seizures during or after brain surgery and/or severe head injury. Phenytoin injection is also used to control or prevent seizures for short periods of time when antiepileptic medicinal products cannot be taken by mouth. Phenyt সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Phenytoin 250 mg/5 ml solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml ampoule contains phenytoin sodium 250 mg (50 mg/ml). Excipients with known effect Each 5 ml also contains 406 mg ethanol 96 %, 21.6 mg of sodium and 2075 mg of propylene glycol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection or Infusion. Clear, colourless, sterile solution practically free from visible particles and pH of solution in the range of 11.5 to 12.1. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Phenytoin injection is indicated for the control of status epilepticus of the tonic-clonic (grand mal) type and prevention and treatment of seizures occurring during or following neurosurgery and/or severe head injury. It is also indicated for the treatment of life-threatening ventricular arrhythmias or arrhythmias secondary to digitalis intoxication, when these have not responded to other available antiarrhythmic treatments or when other antiarrhythmic agents cannot be used. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit. Parenteral Phenytoin injection is suitable for use as long as it remains free of haziness and precipitate. Upon refrigeration or freezing a precipitate might form; this will dissolve again after the solution is allowed to stand at room temperature. The product is still suitable for use. Only a clear solution should be used. There is a relatively small margin between full therapeutic effect and minimally toxic doses of this medicine. Optimum control without clinical signs of toxicity occurs most often with serum levels between 10 and 20 mg/l (40-80 micromoles/l). Because of the risk of local toxicity, intravenous Phenytoin injection should be injected slowly directly into a large vein through a large-gauge needl সম্পূর্ণ নথি পড়ুন