THIOPENTAL Powder for solution for injection (2018)
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Περιεχόμενα
Name of the medicinal product
Thiopental 500mg powder for solution for injection.
Qualitative and quantitative composition
1 vial contains 500 mg thiopental sodium and sodium carbonate (equivalent to 470 mg thiopental sodium). Excipient with known effect: Each vial of 500 mg contains 53 mg (2.3 mmol) sodium/vial. For the full ...
Pharmaceutical form
Powder for solution for injection. Yellowish-white powder.
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. ...
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 anesthetics should be constantly available during the administration ...
Contraindications
Hypersensitivity to barbiturates or to any of the excipients listed in section 6.1. Thiopental is contra-indicated in respiratory obstruction, acute asthma, severe shock and dystrophia myotonica. Administration ...
Special warnings and precautions for use
Thiopental may cause addiction. Keep endotracheal intubation equipment, oxygen and resuscitative equipment readily available. Caution must be taken in patients with increased intracranial pressure or asthma. ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions Thiopental sodium has been shown to interact with sulphafurazole. Reduced initial doses may be required to achieve adequate anaesthesia, but repeat doses may also be necessary ...
Fertility, pregnancy and lactation
Pregnancy It has been shown that thiopental can be used without adverse effects during pregnancy. However, when considering use of thiopental the clinician should only use the drug when the expected benefits ...
Effects on ability to drive and use machines
This medicinal product has major influence on the ability to drive and use machines. Even though the recovery after use of this medicinal product is rapid; post-operative vertigo, disorientation and sedation ...
Undesirable effects
The frequencies of adverse events are ranked according to the following: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), ...
Overdose
Overdosage may occur from too rapid or repeated injections. Too rapid injection may be followed by an alarming fall in blood pressure and shock. Apnea may occur in connection with too excessive or too ...
Pharmacodynamic properties
Pharmaceutical group: General anesthetics ATC Code: N01AF03 This medicinal product is a thiobarbiturate with rapid onset for intravenous administration. Thiopental induces hypnosis and anesthesia, but ...
Pharmacokinetic properties
Following intravenous administration, unconsciousness occurs within 30 seconds and will be continued for 20 to 30 minutes after a single dose. Rapid uptake occurs to most vascular areas of the brain followed ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.
List of excipients
None.
Incompatibilities
This medicine must not be mixed with other medicinal products except those mentioned in section 6.6. The solutions prepared with THIOPENTAL are strongly alkaline and are not compatible with volume replacement ...
Shelf life
Shelf life: 3 years. Shelf-life after reconstitution: Chemical and physical in-use stability has been demonstrated for 9 hours below 25°C and 24 hours at 2°C to 8°C. From a microbiological point of view, ...
Special precautions for storage
This medicinal product does not require any special storage conditions. For storage conditions after reconstitution of the medicinal product, see section 6.3. For single use after reconstitution. Discard ...
Nature and contents of container
20 mL vials made from colourless type III glass with a rubber stopper, aluminium seal and a polypropylene flip-off cap. Pack size: 1, 10, 25 and 50 vials. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Solutions should be prepared aseptically with one of the three following diluents: Sterile Water for Injection (according Ph.Eur.), solution for infusion of sodium chloride (9 mg/ml), 5% dextrose solution ...
Marketing authorization holder
PANPHARMA, Z.I. du Clairay, 35133, Luitré, France
Marketing authorization number(s)
PL 44124/0021
Date of first authorization / renewal of the authorization
05/01/2018
Date of revision of the text
30/01/2018
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