Pentocur 0,5 g Pulver till injektionsvätska, lösning

Țară: Suedia

Limbă: suedeză

Sursă: Läkemedelsverket (Medical Products Agency)

Ingredient activ:

tiopentalnatrium

Disponibil de la:

Abcur AB

Codul ATC:

N01AF03

INN (nume internaţional):

sodium thiopental

Dozare:

0,5 g

Forma farmaceutică:

Pulver till injektionsvätska, lösning

Compoziție:

tiopentalnatrium 0,5 g Aktiv substans

Tip de prescriptie medicala:

Receptbelagt

Rezumat produs:

Förpacknings: Injektionsflaska, 1 x 1 st (0,5 g); Injektionsflaska, 10 x 1 st (0,5 g); Injektionsflaska, 20 x 1 st (0,5 g); Injektionsflaska, 50 x 1 st (0,5 g)

Statutul autorizaţiei:

Godkänd

Data de autorizare:

2012-12-06

Caracteristicilor produsului

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