Kraj: Szwecja
Język: szwedzki
Źródło: Läkemedelsverket (Medical Products Agency)
tiopentalnatrium
Abboxia AB
N01AF03
sodium thiopental
Pulver till injektionsvätska, lösning
tiopentalnatrium 1 g Aktiv substans
Receptbelagt
Förpacknings: Injektionsflaska, 1 x 0,5 g; Injektionsflaska, 10 x 0,5 g; Injektionsflaska, 1 x 1,0 g; Injektionsflaska, 10 x 1,0 g
Avregistrerad
2021-02-09
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PENTOCUR 0.5 G POWDER FOR SOLUTION FOR INJECTION PENTOCUR 1 G POWDER FOR SOLUTION FOR INJECTION thiopental 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 or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Pentocur is and what it is used for 2. What you need to know before you are given Pentocur 3. How Pentocur is given 4. Possible side effects 5. How to store Pentocur 6. Contents of the pack and other information 1. WHAT PENTOCUR IS AND WHAT IT IS USED FOR Pentocur contains the active substance “thiopental sodium”. It is a thiobarbiturate with rapid onset for intravenous administration. Pentocur is used: • to start general anaesthesia (a state of heavy sleep e.g. during surgery) • to provide hypnosis (you are sleepy but not completely asleep) during anaesthesia together with other anaesthetic agents • as part of treatment for cramps (including those caused by local anaesthetics) • to reduce pressure in the skull (intracranial pressure) in patients where the pressure is increased (if respiratory assistance is provided) 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PENTOCUR PENTOCUR SHOULD NOT BE GIVEN TO YOU: - if you are allergic to thiopental, barbiturates or any of the other ingredients of this medicine (listed in section 6) - in case of obstruction of the airways (respiratory obstruction) - if you have acute asthma (severe asthma attack) - if you suffer from hereditary muscle degeneration (myotonic dystrophy) - if you are in severe shock - if you have porphyria WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before you are given Pentocur. The health care professionals should be extra careful and may have to adjust your dose, if you ha Przeczytaj cały dokument
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 Przeczytaj cały dokument