PERFAN Concentrate for solution for injection or infusion Ref.[27497] Active ingredients: Enoximone

Perfan 5mg/ml concentrate for solution for injection or infusion must be diluted 1:1 with either 0.9% sodium chloride injection or water for injection before administration.

Loading Dose: 0.5mg/kg initialy at a rate not greater than 12.5mg/min. This dose may be repeated in 30 minutes. A loading dose of 0.5mg/kg often produces increase in cardiac index of at least 25%. Peak response usually noted by 30 minutes. Some patients may benefit from a third bolus given after 60 minutes.

Maintenance Dose:

Infusion: 2.5-5micrograms/kg/min following loading dose. Most patients respond satisfactorily to 2.5-5.0 micrograms/kg/min. Maintaing and readjusting the infusion rate to the lowest effective dose is advisable.

Accumulation of enoximone and enoximone sulfoxide has been observed at infusion rates of 10microgarms/kg/min.

Continued response to enoximone has been observed in studies using continuous 4-8 hours infusion doses of 2.5-10 micrograsm/kg/min.

In clinical use, some patients have received up to 20microgarms/kg/min for variable durations; the benefit of higher doses must be weighded against the potential increase inside effects.

Intermittent Bolus:

0.5mg/kg every 4 to 8 hours after the initial dose. This dose may be repeated in 30 and 60 minutes depende on patient response. In studies using intermittent bolus not boluses over a 24 hour peroid patients responding well to the initial bolus series maintain their response throughout therapy.

Patients with Renal Dysfucntion

In patients with creatinine clearance below 40ml/min, enoximine clearance is signiificantly reduced and the ratio of enoximone sulfoxide (a metabolite which has shown activity in animal studies) to enoximone plasma concentrations is significantly increased. Therefore, the clinical benefits of enoximone must be carefully weighed against the potential risk of drug and metabolite accumulation. Continuous ECG and frequent blood pressure monitoring are recommended as a precaution against significant changes in cardiaa rhythm or blood pressure. Enoximone should be given by intermittent bolus rather than continuous infusion. The initial loading dose is given at standard doses and may be repeated in 30 minutes if there has been no response. Base on reductions in enoximone clearance, the maintenance dose is reduced.

Intravenous administration of Perfan 5 mg/ml concentrate for solution for injection or infusion has been shown to produce reductions in blood pressure with occasional instances of hypotensive symptoms. If symptomatic hypotension is observed, administration of Perfan 5mg/ml concentrate for solution for injection should be reduced or discontinued. No specific antidote is known, but general measures for circulatory support should be taken.

Unopened: 3 years.

Use immediately once diluted.

Do not store above 30ºC.

In-use: see section 6.3 and section 6.6.

Glass ampoules (TypeI Ph.Eur.) of 20ml in cartons containing 10 ampoules.

Prior to administration, Perfan 5mg/ml concentrate for solution for injection or infusion must be diluted 1:1 with isotonic sodium chloride solution or water for injections. Dilution should take place immediately prior to intravenous administration.

Perfan 5mg/ml concentrate for solution for injection or infusion may only be diluted with sodium chloride solution or water for injections. Other solutions, in particular glucose solution must not be used for dilution because of potential incompatibilities.

The diluted solution is clear and has a yellow colour. The product must not be used if the solution is not clear or contains a precipitate.

For dilution and administration of Perfan 5mg/ml concentrate for solution for injection or infusion, only equipment and syringes consisting of plastic materials generally used in hospitals may be used since crystallisation is possible when dilution is carried out in glass vessels.

Following dilution 1:1, 40ml of ready-to-use solution contains 100mg enoximone, 1ml of this solution contains 2.5mg enoximone.

Perfan 5mg/ml concentrate for solution for injection or infusion ampoules are for single use only. After dilution, use immediately and discard any unused portion. Any unused product or waste material should be disposed of in accordance with local requirements.