DANTRIUM IV

5mg/kg body weight (8-10 vials in adults). As long as the main clinical symptoms of tachycardia, hypoventilation, sustained hyperacidity (pH and pCO2 monitoring required) and hyperthermia persist, bolus injection should be repeated.

In most cases, a total dose of 10mg/kg body weight per 24hr is sufficient. This dose (10mg/kg) may need to be exceeded in individual cases. Safe uses up to 40mg/kg have been described. Based on this experience, higher dosages can be administered in isolated cases if required.

Paediatric population No dosage adjustment required. Method of administration For intravenous administration. Each vial should be prepared by adding 60ml of sterile water for injection and the vial shaken until the solution is dissolved.

The reconstituted solution should be filtered using the single use filter provided. 6.

Tabulated list of adverse reactions Adverse Drug Reactions related to dantrolene sodium are presented below according to system organ class and frequency.

Frequencies are defined according to:

Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1000 to < 1/100) Rare (≥ 1/10000 to < 1/1000) Very rare (<1/10000) Not known: frequency could not be estimated due to the present data System Organ Class Frequency Adverse Drug Reaction Immune system disorders Unknown Allergic reactions, anaphylaxis Metabolism and nutrition disorders Unknown Hyperkalaemia Nervous system disorders Unknown Drowsiness, dizziness, general weakness, somnolence, convulsion, speech disorder, headache Cardiac disorders Unknown Cardiac failure, bradycardia, tachycardia Vascular disorders Unknown Thrombophlebitis Respiratory, thoracic and mediastinal disorders Unknown Pulmonary oedema, Pleural effusion, respiratory failure, respiratory depression Gastrointestinal disorders Unknown Abdominal pain/cramps, nausea, vomiting, gastrointestinal bleeding, diarrhoea Hepatobiliary disorders Unknown Jaundice, hepatitis, hepatic dysfunction including fatal hepatic failure, idiosyncratic or hypertensive liver diseases Skin and subcutaneous disorders Unknown Urticaria, erythema, hyperhidrosis Musculoskeletal and connective tissue disorders Unknown Muscle weakness, muscle fatigue Renal and urinary disorders Unknown Crystalluria Reproductive system and breast disorders Unknown Uterine hypotonia General disorders and administration site conditions Unknown Fatigue, administration site reactions Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The use of Dantrium IV in the management of malignant hyperthermic crisis is not a substitute for other supportive measures. These must be individually continued in their various forms. Dantrium IV may only be infused intravenously. 5), extravascular injection/infusion must be avoided as it can lead to tissue necrosis.

Due to the risk of vascular occlusion, intraarterial injections must be avoided. Spill of the solution on skin should be avoided. If solution gets on the skin, it must be removed with sufficient water. In addition, due to the potential for undissolved crystals/particles to appear in the re-constituted product and the subsequent potential risk of exacerbation of injection site reactions/tissue necrosis from crystals within affected vials, use of the filtration device when drawing up the solution is required at all times.

Each vial of Dantrium IV contains 3g mannitol (for adjustment of isotonic solutions). This amount should be considered if mannitol is used to prevent and treat renal complications related to malignant hyperthermia. ), as an increase in serum potassium has been demonstrated in animal trials as a result of dantrolene.

Liver damage may occur during dantrolene therapy. This is dependent on the dosage and duration of therapy and may run a lethal course. This medicine contains less than 1mmol sodium (23mg) per vial that is to say essentially “sodium free”.

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