Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Phenobarbital sodium
Martindale Pharmaceuticals Ltd
N03AA; N03AA02
Phenobarbital sodium
60 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Barbiturates and derivatives; phenobarbital
Not marketed
1994-05-16
PACKAGE LEAFLET: INFORMATION FOR THE USER PHENOBARBITAL SODIUM INJECTION 15MG/ML, 30MG/ML, 60MG/ML OR 200MG/ML Phenobarbital Sodium (Referred to as Phenobarbital Injection in this leaflet) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, please ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Phenobarbital Injection is and what it is used for 2. Before Phenobarbital Injection is given 3. How Phenobarbital Injection will be given 4. Possible side effects 5. How to store Phenobarbital Injection 6. Further information 1. WHAT PHENOBARBITAL INJECTION IS AND WHAT IT IS USED FOR Phenobarbital belongs to a group of drugs known as barbiturates. Barbiturates have antiepileptic properties which mean they help prevent some types of epileptic seizures. They can also make you feel sleepy. Phenobarbital Injection is used in the treatment of most types of epilepsy except absence seizures (petit mal). 2. BEFORE PHENOBARBITAL INJECTION IS GIVEN DO NOT USE PHENOBARBITAL INJECTION IF: • You are allergic (hypersensitive) to any barbiturates or any of the ingredients of this medicine (see section 6) • You suffer from acute intermittent porphyria (a type of blood disorder) • You suffer from severe breathing difficulties (respiratory depression) • You suffer from liver or kidney problems If your problem is not severe your doctor may decide to give you the medicine with caution. Talk to your doctor, they will advise you on your particular situation. TAKE SPECIAL CARE WITH PHENOBARBITAL INJECTION IF: • You have an alcohol or drug problem • You are pregnant, planning to become pregnant or are breast-feeding • You are young, Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Phenobarbital Sodium 60mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 60mg of Phenobarbital sodium. Each ml of solution contains 0.934g of propylene glycol For excipients, see 6.1. 3 PHARMACEUTICAL FORM Solution for Injection Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS An anti-convulsant for the treatment of all forms of epilepsy except absence seizures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of Administration By intramuscular, subcutaneous or, after dilution with 10 times its own volume of Water for Injection, by slow intravenous administration. Adults 50-200mg as a single dose by intramuscular, subcutaneous or, after, by intravenous injection. Repeated, if necessary, after 6 hours. Maximum daily intake 600mg. Elderly The use of phenobarbital must be the subject of a clinical risk/benefit assessment. Dose schedules may need to be reduced. Children 3-5mg per kilogram body weight as a single dose by the intramuscular route. 4.3 CONTRAINDICATIONS Acute intermittent porphyria. Severe renal, hepatic or respiratory dysfunction. Known hypersensitivity to barbiturates or any of the ingredients. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _4_ _/_ _0_ _1_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _0_ _7_ _6_ _7_ _1_ _9_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Sui Прочитайте повний документ