Special Warning : אזהרת שימוש

4.4      Special warnings and precautions for use
The use of Ventavis is not recommended in patients with unstable pulmonary hypertension, with advanced right heart failure. In case of deterioration or worsening of right heart failure transfer to other medicinal products should be considered.

Hypotension
Blood pressure should be checked while initiating Ventavis. In patients with low systemic blood pressure and in patients with postural hypotension or receiving medicinal products known to reduce blood pressure levels, care should be taken to avoid further hypotension.
Ventavis should not be initiated in patients with systolic blood pressure less than 85 mmHg.
Physicians should be alerted to the presence of concomitant conditions or medicinal products that might increase the risk of hypotension and syncope (see section 4.5).

Syncope
The pulmonary vasodilatory effect of inhaled iloprost is of short duration (one to two hours). Syncope is a common symptom of the disease itself and can also occur under therapy. Patients who experience syncope in association with pulmonary hypertension should avoid any exceptional straining, for example during physical exertion. Before physical exertion it might be useful to inhale. The increased occurrence of syncope can reflect therapeutic gaps, insufficient effectiveness and/or deterioration of the disease. The need to adapt and/or change the therapy should be considered (see section 4.8).

Patients with diseases of the respiratory tract
Ventavis inhalation might entail the risk of inducing bronchospasm, especially in patients with bronchial hyperactivity (see section 4.8). Moreover, the benefit of Ventavis has not been established in patients with concomitant Chronic Obstructive Pulmonary Disease (COPD) and severe asthma.

Patients with concomitant acute pulmonary infections, COPD, and severe asthma should be carefully monitored.


Pulmonary veno-occlusive disease
Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease. Should signs of pulmonary oedema occur, the possibility of associated pulmonary veno-occlusive disease should be considered and treatment with Ventavis should be discontinued.
Interruption of therapy
In case of interruption of Ventavis therapy, the risk of rebound effect is not formally excluded. Careful monitoring of the patient should be performed, when inhaled iloprost therapy is stopped and an alternative treatment should be considered in critically ill patients.

Renal or hepatic impairment
Data with intravenously administered iloprost indicated that the elimination is reduced in patients with hepatic dysfunction and in patients with renal failure requiring dialysis (see section 5.2). A cautious initial dose titration using dosing intervals of 3-4 hours is recommended (see section 4.2).

Serum glucose levels
Prolonged oral treatment with iloprost clathrate in dogs up to one year was associated with slightly increased fasted serum glucose levels. It cannot be excluded that this is also relevant to humans on prolonged Ventavis therapy.

Undesirable exposure to Ventavis
To minimise accidental exposure, it is recommended to use Ventavis with nebulisers with inhalation-triggered systems (such as I-Neb), and to keep the room well ventilated.
Newborns, infants and pregnant women should not be subjected to Ventavis in the room air.

Skin and eye contact, oral ingestion
Ventavis nebuliser solution should not come into contact with skin and eyes; oral ingestion of Ventavis solution should be avoided. During nebulisation sessions a facial mask must be avoided and only a mouthpiece should be used.

Ventavis contains ethanol
Ventavis 10 microgram/ml contains 0.81 mg alcohol (ethanol) in each ml which is equivalent to 0.081% (w/v). The amount of 0.81 mg of alcohol in 1 ml of this medicine is equivalent to less than 1 ml beer or wine.
The small amount of alcohol in this medicine will not have any noticeable effects.

Effects on Driving

4.7    Effects on ability to drive and use machines

Ventavis has major influence on the ability to drive and use machines for patients experiencing hypotensive symptoms such as dizziness.
Care should be exercised during initiation of therapy until any effects on the individual have been determined.