PERFAN

Perfan Injection is for intravenous administration (slow injection or continuous infusion) and must be diluted before use. 0. 9 % sodium chloride injection or water for injections before administration. Do not use more dilute solutions or other diluents, particularly dextrose injection, as crystal formation may occur.

Use only plastic containers or syringes for dilution. When Perfan Injection has been diluted in glass containers or syringes, crystal formation has been observed within approximately 1 hour. Method of Administration The following procedure is recommended for the administration of the diluted Perfan® Injection.

0 mg/kg is reached. Alternatively, treatment may be initiated as an infusion at a rate of 90 μg/kg/minute administered over 10 - 30 minutes until the required haemodynamic response is achieved. 0 mg/kg) may be repeated as required every 3 - 6 hours and adjusted according to the response of the patient: Alternatively, a continuous or intermittent infusion at a rate of 5 to 20 μg/kg/minute may be instituted.

0 mg/kg. In patients with renal impairment the dosage or dosage frequency may need to be reduced. This dosing regimen will produce, in the majority of patients, a 30 % or greater increase in cardiac output and/or decreases in pulmonary capillary wedge pressure of about 30 % and right atrial pressure of about 40 %.

It should be noted that the initial haemodynamic response determines the subsequent rate of administration as well as the duration of treatment. Precautions should be taken to avoid venous extravasation during administration. The duration of therapy should depend on the patient’s continued positive and beneficial response.

Sustained haemodynamic and clinical effects have been observed in patients treated for up to 48 hours. Use in children Safety and effectiveness in children have not been established. There is no experience in children.

The following undesirable effects have been reported:

Common (>1/100 to <1/10): − hypotension* − insomnia − headache − platelet count reduction (without clinical symptoms, e. g. 000 to <1/100): − ventricular tachycardia and supraventricular arrhythmia (e. g. 4 ‘Special warnings and precautions for use’ 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

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.

Hypersensitivity to the active substance or to any of the excipients.