DANTRIUM Powder for solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Dantrium IV 20mg.
Qualitative and quantitative composition
Each vial contains 20mg dantrolene sodium. For the full list of excipients, see 6.1.
Pharmaceutical form
Powder for solution for injection.
Therapeutic indications
For the treatment of malignant hyperthermia.
Posology and method of administration
Posology As soon as the malignant hyperthermia syndrome is recognised all anaesthetic agents should be discontinued. An initial Dantrium IV dose of 1mg/kg should be given rapidly into the vein. If the ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
In some subjects as much as 10mg/kg of Dantrium IV has been needed to reverse the crisis. In a 70kg man this dose would require approximately 36 vials. Such a volume has been administered in approximately ...
Interaction with other medicinal products and other forms of interaction
The combination of therapeutic doses of intravenous dantrolene sodium and verapamil in halothane/alpha-chloralose anaesthetised swine has resulted in ventricular fibrillation and cardiovascular collapse ...
Fertility, pregnancy and lactation
Pregnancy The safety of Dantrium IV in pregnant women has not been established. Dantrolene crosses the placenta, and should be given only when the potential benefits have been weighed against the possible ...
Effects on ability to drive and use machines
A decrease in grip strength and weakness of leg muscles, especially walking down stairs, can be expected post-operatively. In addition, symptoms such as lightheadedness may be noted. Since some of these ...
Undesirable effects
Summary of the safety profile There have been occasional reports of death following malignant hyperthermia crisis even when treated with intravenous dantrolene sodium; incidence figures are not available ...
Overdose
None stated.
Pharmacodynamic properties
Pharmacotherapeutic group: Muscle relaxants, directly acting agents ATC code: M03CA01 Mechanism of action The receptor molecule for dantrolene has not been identified. Radiolabelled dantrolene sodium binds ...
Pharmacokinetic properties
Distribution Dantrolene sodium is a highly lipophobic drug. In addition, it lacks hydrophilicity. Dantrolene sodium binds to human serum albumin (HSA) with a molar ratio of 0.95 to 1.68 in-vitro. The association ...
Preclinical safety data
Carcinogenicity Whilst there is no clinical evidence of carcinogenicity in humans, this possibility cannot be absolutely excluded. Dantrolene sodium has shown some evidence of tumourgenicity at high dose ...
List of excipients
Mannitol Sodium hydroxide
Incompatibilities
Dantrium IV should not be mixed with other intravenous infusions.
Shelf life
Shelf life: Three years. The reconstituted solution should be usedwithin six hours.
Special precautions for storage
Unopened product: Do not store above 25°C. Reconstituted solution: store between 15 and 25°C. Do not refrigerate or freeze. Protect from direct light.
Nature and contents of container
Type I glass vial with chlorobutyl rubber stopper with aluminium seal. Each vial is provided with a single-use filtration device. Supplied in packs of 12 or 36 vials. Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
Reconstitution Each vial of Dantrium IV should be reconstituted by adding 60ml of water for injection Ph.Eur, and shaken until the powder is dissolved. Filter the reconstituted product with the single-use ...
Marketing authorization holder
Norgine Pharmaceuticals Limited, Norgine House, Widerwater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK
Marketing authorization number(s)
PL 20011/0034
Date of first authorization / renewal of the authorization
14/02/1980
Date of revision of the text
02 January 2019
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