País: Nova Zelândia
Língua: inglês
Origem: Medsafe (Medicines Safety Authority)
Phenobarbital 30mg; ; ; ;
Noumed Pharmaceuticals Limited
Phenobarbital 30 mg
30 mg
Tablet
Active: Phenobarbital 30mg Excipient: Lactose monohydrate Magnesium stearate Purified talc Wheat starch
Blister pack, 90 tablets
Class C5 Controlled Drug
Class C5 Controlled Drug
Nantong Jinghua Pharmaceutical Co., Ltd.
Phenobarbitone is indicated for use as preoperative medication to help reduce anxiety and facilitate induction of anaesthesia. Phenobarbitone a long acting barbiturate is indicated as long term anticonvulsant therapy for the treatment of generalised tonic-clonic and simple partial (cortical focus) seizures. Seizures (prophylaxis and treatment) of febrile seizures.
Package - Contents - Shelf Life: Blister pack, - 90 tablets - 60 months from date of manufacture stored at or below 25°C - Blister pack, - 500 tablets - 60 months from date of manufacture stored at or below 25°C
1969-12-30
NEW ZEALAND DATA SHEET New Zealand Data Sheet Page 1 of 16 1. PRODUCT NAME Phenobarbitone (Noumed), Tablet, 15mg Phenobarbitone (Noumed), Tablets, 30mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Name and strength of the active substance Phenobarbital 15mg Phenobarbital 30mg Excipient(s) with known effect Contains gluten and sugars (as lactose). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral – tablet Presentations Phenobarbitone (Noumed) tablets 15 mg: A white, biconvex, circular tablet. Phenobarbitone (Noumed) tablets 30 mg: A white, biconvex, circular tablet. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Phenobarbital is indicated for use as preoperative medication to help reduce anxiety and facilitate induction of anaesthesia. Phenobarbital a long-acting barbiturate is indicated as long-term anticonvulsant therapy for the treatment of generalised tonic-clonic and simple partial (cortical focus) seizures. Seizures (prophylaxis and treatment) of febrile seizures. 4.2 Dose and method of administration Phenobarbital is a barbiturate which may be used as an antiepileptic agent to control tonic- clonic (grand mal) and partial (focal) seizures. The dose should be adjusted to the needs of the individual patient to achieve adequate control of seizures; this usually requires plasma concentrations of 10 to 40mcg per mL (43 to NEW ZEALAND DATA SHEET New Zealand Data Sheet Page 2 of 16 172 micromoles per litre). Up to 350 mg daily in divided doses may be taken. 4.3 Contraindications Hypersensitivity to barbituric acid derivatives. Phenobarbital is contraindicated in patients with acute intermittent porphyria, severe respiratory depression or pulmonary insufficiency, renal impairment, hepatic impairment, sleep apnoea, uncontrolled diabetes mellitus, severe anaemia due to folate deficiency, hyperkinetic children, suicidal potential, alcoholism, and drug dependency. Phenobarbital is also contraindicated in those who have a natural or acquired idiosyncrasy to barbiturates. Not to be admin Leia o documento completo