CEDOCARD Solution for infusion Ref.[50278] Active ingredients: Isosorbide dinitrate

Dosage

Adults, including the elderly

Intravenous route: A dose of between 2mg and 12mg per hour is usually satisfactory. However, dosages up to 20mg per hour administered should be adjusted to the patient response.

Intra-coronary Route: The usual dose is 1mg given as a bolus injection prior to balloon inflation. Further doses maybe given not exceeding 5mg within a 30 minute period.

Children

The safety and efficacy of Cedocard has not yet been established in children.

Administration

Cedocard is a concentrated solution and must be diluted prior use. The diluted solution should never be injected directly in the form of a bolus except via the intra-coronary route prior to balloon inflation. A dilution of 50% is advocated for intracoronary administration. Cedocard can be administered as an intravenous admixture with a suitable vehicle such as sodium chloride injection BP or dextrose injection BP. Prepared Cedocard admixtures should be given by intravenous infusion or with the aid of a syringe pump incorporating a glass or rigid plastic syringe. During administration the patients blood pressure and pulse should be closely monitored.

General supportive therapy.

5 years, as packaged for sale. Admixtures are stable for approximately 24 hours at room temperature in the recommended containers. Open ampoules or bottles should be used immediately and any unused drug discarded.

Store between 15-25°C.

10ml glass ampoules and 50ml, 100ml glass vials.

Clear, Type I glass vials sealed with a grey stopper and a red flip-off aluminium cap, containing 50ml or 100ml of concentrate. The bottle is packed in a cardboard carton containing a Sterifix Minispike to aid withdrawal of the product from the bottle.

Example of admixture preparationTo obtain a dose of 6 mg per hour, add 50 ml of Cedocard 0.1% to 450 ml of a suitable vehicle, under aseptic conditions. The resultant admixture (500ml) contains 100 µg/ml (1mg/10ml) isosorbide dinitrate. An infusion rate of 60ml per hour (equivalent to 60 paediatric microdrops per minute or 20 standard drops per minute) will deliver the required dose of 6mg per hour. Should it be necessary to reduce fluid intake, 100ml of Cedocard 0.1% may be diluted to 500ml using a suitable vehicle. The resultant solution now contains 200 µg/ml (2mg/10ml) isosorbide dinitrate.

An infusion rate of 30ml per hour (equivalent to 30 paediatric microdrops per minute or 10 standard drops per minute), will deliver the required dose of 6 mg per hour. A dilution of 50% is advocated to produce a solution containing 0.5 mg/ml where fluid intake is strictly limited.