Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Phenytoin sodium
Advanz Pharma
N03AB02
Phenytoin sodium
50mg/1ml
Solution for injection
Intravenous; Intramuscular
No Controlled Drug Status
Valid as a prescribable product
BNF: 04080200; GTIN: 5021691164180
OBJECT 1 PHENYTOIN SODIUM 50MG/ML SOLUTION FOR INJECTION Summary of Product Characteristics Updated 19-Dec-2017 | Concordia International - formerly AMCo 1. Name of the medicinal product Phenytoin Sodium 50mg/ml Solution for Injection 2. Qualitative and quantitative composition Each 5ml of solution contains Phenytoin Sodium 250mg. Excipient(s) with known effect Each 5ml of solution also contains 395.75 mg of Ethanol and not more than 23mg of Sodium. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for Injection. A clear colourless particle free solution. 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. 4.2 Posology and method of administration Posology _Status epilepticus :_ In a patient having continuous seizure activity, as compared to the more common rapidly recurring seizures, i.e. serial epilepsy, intravenous diazepam or a short-acting barbiturate is recommended prior to administration of phenytoin because of the more rapid onset of action of the former. Following the use of diazepam in patients having continuous seizures and in the initial management of serial epilepsy a loading dose of phenytoin 10 - 15mg/kg should be injected slowly intravenously, at a rate not exceeding 50mg per minute in adults (this will require approximately 20 minutes in a 70kg patient). The loading dose should be followed by maintenance doses of 100mg orally or intravenously every 6 to 8 hours. In neonates, it has been shown that absorption of phenytoin is unreliable after oral administration, but a loading dose of 15-20mg/kg of phenytoin intravenously will usually produce serum concentrations of 10– 20 mg/l phenytoin which is within the generally accepted therapeutic range. The drug should be injected slowly intravenously at a rate of 1-3mg/kg/min. Determination of phenytoin seru Prečítajte si celý dokument