Perfan Injection should be used cautiously when heart failure is associated with hypertrophic cardiomyopathy, stenotic or obstructive valvular disease or other outlet obstruction. Blood pressure and heart rate should be closely monitored during intravenous administration of Perfan Injection.
In patients who show symptomatic decreases in blood pressure, Perfan Injection should be administered at a reduced rate or, if necessary, should be stopped. Patients with severe congestive heart failure have a high incidence of arrhythmias and are particularly vulnerable to the development of arrhythmias.
It is recommended that patients be observed closely while receiving Perfan Injection. Electrolyte and Fluid Balance Fluid and electrolyte status and renal function should be assessed during therapy with Perfan Injection. Improvement in cardiac output with associated diuresis may require a reduction in the dose of diuretic drugs.
Abnormal serum potassium levels (which may be due to excessive diuresis) may predispose patients to arrhythmias especially those on digitalis. Therefore, serum potassium levels should be monitored carefully and corrective measures should be instituted before or during therapy with Perfan Injection.
Hypovolaemia with inadequate cardiac filling pressure (which may be due to diuretic therapy) may prevent patients from responding adequately to Perfan Injection. Fluid and electrolyte status should be continuously monitored and corrective measures should be instituted before or during therapy with Perfan Injection.
Management of Adverse Reactions Arrhythmias The occurrence of severe supraventricular and ventricular arrhythmias may require immediate discontinuation of Perfan Injection and institution of appropriate antiarrhythmic therapy. Platelet Count Reduction Platelet counts before and during therapy are recommended.
Gastrointestinal Side Effects Severe gastrointestinal side effects may be managed by reducing dosage, or if necessary, administration of Perfan Injection may be temporarily interrupted. Increases in Hepatic Enzyme Levels It is recommended to monitor patients for changes in hepatic enzyme levels.
If clinically significant increases in hepatic enzymes occur following the intravenous administration of Perfan Injection, therapy should be discontinued. 4 vol % ethanol (alcohol), i. e. 44 g in the maximum daily dose of 360 mL (based on the recommendation that the total daily dose should not exceed 24 mg/kg and assuming a patient with 75 kg), equivalent to appr.
750 ml beer resp. 300 ml wine per maximum daily dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease or epilepsy.
The amount of alcohol in this medicinal product may alter the effects of other medicines. The amount of alcohol in this medicinal product may impair your ability to drive or use machines. This medicine contains less than 1 mmol sodium (23 mg) per 20 ml-ampoule, that is to say essentially ‘sodium-free’.
This medicinal product contains propylene glycol. Various adverse events, such as hyperosmolality, lactic acidosis; renal dysfunction (acute tubular necrosis), acute renal failure; cardiotoxicity (arrhythmia, hypotension); central nervous system disorders (depression, coma, seizures); respiratory depression, dyspnoea; liver dysfunction; haemolytic reaction (intravascular haemolysis) and haemoglobinuria; or multisystem organ dysfunction, have been reported with high doses or prolonged use of propylene glycol.
Adverse events usually reverse following weaning off of propylene glycol, and in more severe cases following hemodialysis. Medical monitoring is required.