Land: Sverige
Språk: svenska
Källa: Läkemedelsverket (Medical Products Agency)
tiopentalnatrium
Abcur AB
N01AF03
sodium thiopental
1 g
Pulver till injektionsvätska, lösning
tiopentalnatrium 1 g Aktiv substans
Receptbelagt
Förpacknings: Injektionsflaska, 1 x 1 st (1 g); Injektionsflaska, 10 x 1 st (1 g); Injektionsflaska, 20 x 1 st (1 g); Injektionsflaska, 50 x 1 st (1 g)
Godkänd
2012-12-06
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Pentocur 0.5 g powder for solution for injection Pentocur 1 g powder for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of Pentocur 0.5 g powder for solution for injection contains 500 mg thiopental sodium (as thiopental sodium and sodium carbonate). Each vial of Pentocur 1 g powder for solution for injection contains 1000 mg thiopental sodium (as thiopental sodium and sodium carbonate). Excipients with known effect: Each vial of Pentocur 0.5 g contains 2.2-2.4 mmol sodium (51-56 mg). Each vial of Pentocur 1 g contains 4.4-4.9 mmol sodium (102-112 mg). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection Yellowish-white powder 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Intravenous anaesthesia. Induction of general anaesthesia and also as an adjunct to provide hypnosis during balanced anaesthesia with other anaesthetic agents, including analgesics and muscle relaxants. As an adjunct for control of _ _ refractory convulsive disorders of various aetiology, including those caused by local anaesthetics. Reducing the intracranial pressure in patients with increased intracranial pressure, if controlled ventilation is provided. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Using of thiopental is reserved only for health care personnel trained in anaesthesiology. A person qualified in the use of anaesthetics should be constantly available during the administration of the medicinal product. After continuous administration of thiopental the effect duration is prolonged, personnel qualified in the use of anaesthetics should be constantly available during the administration of the medicinal product. A normal adult dose for induction of anaesthesia is 4-6 mg/kg body weight, but the individual response to the drug is so varied that there can be no fixed dosage. The drug should be titrated against patient requirements as governed by age, sex, body weight and the p Läs hela dokumentet