国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Phenytoin sodium
Viatris UK Healthcare Ltd
N03AB02
Phenytoin sodium
50mg/1ml
Solution for injection
Intramuscular; Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 04080200; GTIN: 5013457011395
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EPANUTIN ® RMP (READY MIXED PARENTERAL) 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 Epanutin RMP 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 Epanutin RMP (or any other form of phenytoin). WHAT IS IN THIS LEAFLET 1. What Epanutin RMP is and what it is used for 2. What you need to know before you are given Epanutin RMP 3. How Epanutin RMP is given 4. Possible side effects 5. How to store Epanutin RMP 6. Contents of the pack and other information _ _ 1. WHAT EPANUTIN RMP 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 drugs. Epanutin RMP 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. Epanutin RMP is also used to control or prevent seizures for short periods of time when antiepileptic drugs cannot be taken by mouth. Epanutin RMP can also be used 阅读完整的文件
OBJECT 1 EPANUTIN READY MIXED PARENTERAL Summary of Product Characteristics Updated 06-Feb-2018 | Pfizer Limited 1. Name of the medicinal product Epanutin Ready Mixed Parenteral 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 440.4 mg ethanol 96% and 24.6 mg of sodium. For the full list of excipients see section 6.1. 3. Pharmaceutical form Solution for Injection or Infusion. Clear, colourless, sterile solution. 4. Clinical particulars 4.1 Therapeutic indications Parenteral Epanutin is indicated for the control of status epilepticus of the tonic-clonic (grand mal) type and for the 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 Method of administration For parenteral administration Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit. Parenteral Epanutin 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. A faint yellow colouration may develop, however, this has no effect on the potency of this solution. There is a relatively small margin between full therapeutic effect and minimally toxic doses of this drug. Optimum control without clinical signs of toxicity occurs most often with serum levels between 10 mcg/mL and 20 mcg/mL (40-80 micromoles/l). Because of 阅读完整的文件