DANTRIUM Powder for solution for injection Ref.[8168] Active ingredients: Dantrolene

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 physiological and metabolic abnormalities persist or reappear, this dose may be repeated up to a cumulative dose of 10mg/kg. Clinical experience to date has shown that the average dose of Dantrium IV required to reverse the manifestations of malignant hyperthermia has been 2.5mg/kg. If a relapse or recurrence occurs, Dantrium IV should be readministered at the last effective dose.

Method of administration

Dantrium 20 mg powder for solution is for intravenous use only.

After reconstitution, the solution must be filtered with the filtration device provided when drawing up the solution into the syringe (see section 4.4).. Remove the single-use filtration device from the syringe prior to attachment to an intravenous cannula or giving set.

For instructions on reconstitution and filtration of the medicinal product before administration, see section 6.6.

None stated.

Shelf life: Three years. The reconstituted solution should be usedwithin six hours.

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.

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.

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 filtration device provided when drawing up the solution into the syringe. The reconstituted solution must be used within 6 hours but filtered immediately before use. Remove the filtration device from the syringe prior to attachment to an intravenous cannula or giving set.

Discard the filtration device and product vial in an approved sharps collector.

Use a new filtration device with every vial of Dantrium IV. Administer Dantrium IV Intravenous immediately upon filtration.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Only use the filtration device provided.