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

Enoximone therapy has been associated with reductions in platelet counts to below 100x 10⁶/L. Platelet count should be monitored.

Enoximone should be used with caution in patients with congestive cardiac failure associated with blood platelet counts below 100x 10⁶/L.

Transient and variable changes in liver function tests have been observed, the patients should be carefully and regularly monitored with reference to hepatic and renal function.

In patients with fast atrial fibrillation or fluter, the enhanced atrioventricular conduction is not affected by enoximone and concommitant administration of digitalis should be considered. In such cases or in those with multifocal or runs of premature ventricular contractions, are ful dose titration and close ECG monitorings advisable, especially during intravenous thearpy.

Blood pressure and heart rate should be monitored during intravenous therapy. Significant increases in heart rate are rare but the rate of infusion may have to be slowed or stopped in patients showing a tendency to hypotension and, if severe, supportive measures and intraveonus fluid administration instituted.

Improvement in cardiac output is often followed by increased renal perfusion with result and diuresis and fluid and electrolyte changes may require correction. Care should be taken during intravenous therapy to avoid extravascular leakage of enoximone since this may cause irritation.

The safety and efficacy of enoximonen ijection for use in children has not been established.

No clinical manifestation of sun toward drug interaction were observed in patients receiving Perfan 5mg/ml concentrate for solution for injection or infusion most of whom concomitantly recieved one or more of the following: diuretics (amiloride, triamterene, frusemide and spironolactone), digitalis glycosides (digoxin), potassium supplements, antiarrhythmics (diltiazem, propranolol, lignocaine, nifedipine, Procainamide and quinidine), vasodilators (captropril, hydralazine, nitroprusside and nitrates), anticoagulants (warfarin and heparin), analgesics (acetylsalicylic acid, paracetamol and codeine), sedatives (chloral hydrate, diazepam and lorazepam) and positive inotropic agents (dobutamine and dopamine).

There are no adequate and well-controlled studies in pregnant women. Perfan 5 mg/ml concentrate for solution for injection or infusion should be used during pregnancy only if the potential benefit justifies the potential risk.

It is not known whether this drug is excreted in human milk. Use in women breastfeeding infants is not recommended.

Not applicable as the product is used on hospitalised patients.

Side effects include ectopic beats, ventricular tachyarrhythmias, supraventricular and other arrythmias, hypotension, headache, insomnia, nausea and/or vomiting or diarrhoea. Chills, oliguria, urinary retention, upper and lower extermity pain and fever.

Perfan 5mg/ml concentrate for solution for infusion may only be diluted with sodium chloride solution or water for injections (see section 6.6).

Other drugs or fluids must not be mixed in the same container or administered concomitantilny the same infusion line as Perfan 5mg/ml concentrate for solution for injection.

Crystal formation has occured when enoximone injection was mixed in glass containers or syringes.

Glucose solutions should not be used as crystal formation may occur.