Drug product Suitable inhalation device (nebuliser) to be used Ventavis 10 microgram/ml Breelib I-Neb AAD Venta-Neb Ventavis should only be initiated and monitored by a physician experienced in the treatment of pulmonary hypertension.
5 microgram iloprost as delivered at the mouthpiece of the nebuliser. If this dose is well tolerated, dosing should be increased to 5 microgram iloprost and maintained at that dose. 5 microgram iloprost. Daily dose The dose per inhalation session should be administered 6 to 9 times per day according to the individual need and tolerability.
Duration of treatment The duration of treatment depends on clinical status and is left to the physician’s discretion. Should patients deteriorate on this treatment intravenous prostacyclin treatment should be considered. 2). To avoid undesired accumulation over the day, special caution has to be exercised with these patients during initial dose titration.
5 microgram iloprost should be administered using Ventavis 10 microgram/ml with dosing intervals of 3-4 hours (corresponds to administration of max. 6 times per day). Thereafter, dosing intervals may be shortened cautiously based on individual tolerability.
If a dose up to 5 microgram iloprost is indicated, again dosing intervals of 3-4 hours should be chosen initially and shortened according to individual tolerability. An accumulation of iloprost following treatment over several days is not likely due to the overnight break in administration of the medicinal product.
Renal impairment There is no need for dose adaptation in patients with a creatinine clearance >30 ml/min (as determined from serum creatinine using the Cockroft and Gault formula). Patients with a creatinine clearance of ≤30 ml/min were not investigated in the clinical trials.
Data with intravenously administered iloprost indicated that the elimination is reduced in patients with renal failure requiring dialysis. Therefore, the same dosing recommendations as in patients with hepatic impairment (see above) are to be applied.
Paediatric population The safety and efficacy of Ventavis in children aged up to 18 years have not been established. No data from controlled clinical trials are available. Method of administration Ventavis is intended for inhalation use by nebulisation.
To minimize accidental exposure it is recommended to keep the room well ventilated. 6). 2). • Breelib Breelib is a small handheld, battery-powered, breath activated, vibrating mesh technology system. 5 microgram and Ventavis 20 microgram/ml nebuliser solution delivers 5 microgram at the mouthpiece of the Breelib nebuliser.
4). If inhalation with Ventavis 10 microgram/ml is well tolerated, the dose should be increased by using Ventavis 20 microgram/ml. This dose should be maintained. 4). The duration of an inhalation session with Breelib nebuliser is approximately 3 minutes, which reflects the higher delivery rate of the Breelib compared to other nebulisers.
Patients initiating Ventavis treatment or switching from an alternative device to Breelib should be closely supervised by the treating physician to ensure that dose and speed of inhalation are well tolerated. When using the Breelib nebuliser please follow the instructions for use provided with the device.
Fill the medication chamber with Ventavis immediately before use. • I-Neb AAD The I-Neb AAD system is a portable, hand-held, vibrating mesh technology nebuliser system. This system generates droplets by ultrasound, which forces the solution through a mesh.
The I-Neb AAD nebuliser has been shown to be suitable for the administration of Ventavis 10 microgram/ml (1 ml ampoule) and 20 microgram/ml nebuliser solution. : around 2 micrometres) but with faster delivery when using Ventavis 20 microgram/ml.
The dose delivered by the I-Neb AAD system is controlled by the medication chamber in combination with a control disc. Each medication chamber is colour coded and has a corresponding colour coded control disc. 5 microgram iloprost as delivered at the mouthpiece of the nebuliser using 1 ml ampoule of Ventavis 10 microgram/ml.
If this dose is well tolerated, dosing should be increased to 5 microgram iloprost using 1 ml ampoule of Ventavis 10 microgram/ml and maintained at that dose. In case of poor tolerability of the 5 microgram dose, the […]