Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
Because of the high pH of the final infusion solutions, care should be taken to avoid extravasation during their administration and consequent risk of tissue damage.

Flolan is a potent pulmonary and systemic vasodilator. The cardiovascular effects during infusion disappear within 30 min of the end of administration.

Flolan is a potent inhibitor of platelet aggregation, therefore, an increased risk for haemorrhagic complications should be considered, particularly for patients with other risk factors for bleeding (see section 4.5).

If excessive hypotension occurs during administration of Flolan, the dose should be reduced or the infusion discontinued. Hypotension may be profound in overdose and may result in loss of consciousness (see section 4.9).

Blood pressure and heart rate should be monitored during administration of Flolan.

Flolan may either decrease or increase heart rate. The change is thought to depend on both the basal heart rate and the concentration of Flolan administered.

The effects of Flolan on heart rate may be masked by concomitant use of drugs which affect cardiovascular reflexes.

Extreme caution is advised in patients with coronary artery disease.

Elevated serum glucose levels have been reported (see section 4.8).
The solvent contains no preservative; consequently a vial should be used once only and then discarded.

Sodium content
This medicinal product contains sodium, which should be taken into consideration by patients on a controlled sodium diet.

The amount of sodium present in the reconstituted concentrate solution equals 73 mg approximately, equivalent to approximately 4 % of the WHO recommended maximum daily dietary intake of 2 g of sodium for an adult.

The amount of sodium present in the powder for solution for infusion equals 3 mg approximately per vial, equivalent to approximately 0.2 % of the WHO recommended maximum daily dietary intake of 2 g of sodium for an adult.

The amount of sodium present in the solvent for parenteral use equals 70 mg approximately per vial, equivalent to approximately 4 % of the WHO recommended maximum daily dietary intake of 2 g of sodium for an adult.

Some patients with pulmonary arterial hypertension have developed pulmonary oedema during dose-ranging, which may be associated with pulmonary veno-occlusive disease. Flolan must not be used chronically in patients who develop pulmonary oedema during dose initiation (see section 4.3).

Abrupt withdrawal or interruption of infusion must be avoided, except in life-threatening situations. An abrupt interruption of therapy can induce a rebound of pulmonary arterial hypertension resulting in dizziness, asthenia, increased dyspnoea, and may lead to death (see section 4.2).

Flolan is infused continuously through a permanent indwelling central venous catheter via a small, portable infusion pump. Thus, therapy with Flolan requires commitment by the patient to sterile drug reconstitution, drug administration, care of the permanent central venous catheter, and access to intense and ongoing patient education.

Sterile technique must be adhered to in preparing the drug and in the care of the catheter. Even brief interruptions in the delivery of Flolan may result in rapid symptomatic deterioration. The decision to administer Flolan for pulmonary arterial hypertension should be based upon the patient’s understanding that there is a high likelihood that therapy with Flolan will be needed for prolonged periods, possibly years, and the patient’s ability to accept and care for a permanent i.v. catheter and infusion pump should be carefully considered.

Effects on Driving

4.7   Effects on ability to drive and use machines
Pulmonary arterial hypertension and its therapeutic management may affect the ability to drive and operate machinery.