What Ventavis contains:
- The active substance
1 ml solution contains 10 micrograms iloprost (as iloprost trometamol).
Each ampoule with 1 ml contains 10 micrograms iloprost.
Each ampoule with 2 ml contains 20 micrograms iloprost.
- The other ingredients are trometamol, ethanol 96%, sodium chloride, hydrochloric acid for pH adjustment, and water for injections.
Ventavis is provided in colourless ampoules (type I glass), containing either 1 ml or 2 ml nebuliser solution.
What Ventavis looks like and content of the pack:
Ventavis is a clear, colourless nebuliser solution for inhalation.
Ventavis is available in packs containing:
- 30, 90, 100, or 300 ampoules with 2 ml for the use with HaloLite, Prodose and Venta-Neb. The ampoules containing 2 ml show two coloured rings (white ? pink).
- or 30 or 168 ampoules with 1 ml for use with the I-Neb nebuliser. The ampoules containing 1 ml show two coloured rings (white - yellow).
Not all pack-sizes may be marketed.
Marketing Authorisation Holder:
Bayer Schering Pharma AG, D-13342 Berlin, Germany
Berlimed S.A., Poligono Industrial Santa Rosa s/n, 28806 Alcalá de Henares, Madrid, Spain
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
BelgiëBelgiqueBelgien Bayer SA-NV TélTel 32-02-535 63 11 LuxembourgLuxemburg Bayer SA-NV TélTel 32-02-535 63 11
. 359-02-81 401 01 Magyarország Bayer Hungária KFT Tel. 36-1-487 4100
eská republika Bayer s.r.o. Tel 420-266 101 111 Malta. Alfred Gera and Sons Ltd. Tel 35-621 44 62 05
Danmark Bayer AS Tlf 45-45 235 000 Nederland Bayer B.V., Bayer Schering Pharma Tel 31-0297-28 06 66
Deutschland Bayer Vital GmbH Tel 49-0214-30 513 48 Norge Bayer AS Tlf 47-24 11 18 00
Eesti Bayer OÜ Tel 372-655 85 65 Österreich Bayer Austria Ges.m.b.H. Tel 43-01-711 460
Bayer 30-210-618 75 00 Polska Bayer Sp. z o.o. Tel. 48-22-572 35 00
España Bayer Hispania S.L. Tel 34-93-495 65 00 Portugal Bayer Portugal S.A. Tel 351-21-416 42 00
France Bayer Santé Tél. 33-03-28 16 34 00 Romania SC Bayer SRL Tel. 40-021-528 59 00
Ireland Bayer Limited Tel 353-01-2999 313 Slovenija Bayer d.o.o. Tel 386-01-58 14 400
Ísland Icepharma hf. Sími 354-540 8000 Slovenská republika Bayer, spol. s r.o. Tel. 421-02-59 21 31 11
Italia Italfarmaco S.p.A. Tel 39-02-644 31 SuomiFinland Bayer Oy, Bayer Schering Pharma PuhTel 358-020-78521
NOVAGEM Limited 357-22-747 747 Sverige Bayer AB Tel 46-08-580 223 00
Latvija SIA Bayer Tel 371-67 84 55 63 United Kingdom Bayer plc Tel 44-01635-56 30 00
Tel. +370-5-23 36 868
This leaflet was last approved in
This medicine has been authorised under ?exceptional circumstances?.
This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
The European Medicines Agency (EMA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
The following information is intended for medical or healthcare professionals only:
Instructions for use and handling
Two compressed air nebuliser systems, HaloLite and Prodose, have been shown to be suitable nebulisers for the administration of Ventavis. For each inhalation session the content of one ampoule containing 2 ml of Ventavis nebuliser solution will be transferred into the nebuliser medication chamber immediately before use. HaloLite and Prodose are dosimetric systems. They stop automatically after the pre-set dose has been delivered. The inhalation time depends on the patient?s breathing pattern.
Device Dose of iloprost at mouthpiece Estimated Inhalation time frequency of 15 breaths per minute HaloLite 2.5 micrograms 5 micrograms 4 to 5 min 8 to 10 min Prodose 2.5 micrograms 5 micrograms 4 to 5 min 8 to 10 min
For a dose of 5 micrograms iloprost at mouthpiece it is recommended to complete two inhalation cycles with 2.5 micrograms pre-set dose program with a filling of one ampoule containing 2 ml Ventavis nebuliser solution, which shows two coloured rings (white ? pink).
For details refer to the instruction manuals of the HaloLite and Prodose nebuliser.
VentaNeb, a portable ultrasonic battery-powered nebuliser, has also been shown to be suitable for the administration of Ventavis. The measured MMAD of the aerosol droplets was 2.6 micrometres. For each inhalation session, the content of one ampoule containing 2 ml of Ventavis nebuliser solution and showing two coloured rings (white ? pink) will be transferred into the nebuliser medication chamber immediately before use.
Two programs can be operated:
P1 Program 1: 5,0 micrograms active substance on the mouth piece 25 inhalation cycles. P2 Program 2: 2,5 micrograms active substance on the mouth piece 10 inhalation cycles. The selection of the pre set program is made by the physician.
VentaNeb prompts the patient to inhale by an optical and an acoustic signal. It stops after the pre-set dose has been administered. To obtain the optimal droplet size for the administration of Ventavis the green baffle plate should be used. For details refer to the instruction manual of the Venta-Neb nebuliser.
Device Dose of iloprost at mouthpiece Estimated Inhalation time VentaNeb 2.5 micrograms 5 micrograms 4 min 8 min
The I-Neb AAD System is a portable, hand-held, vibrating mesh technology nebuliser system, This system generates droplets by ultrasound, which is forcing the solution through a mesh. The I-Neb AAD nebuliser has also been shown to be suitable for the administration of Ventavis. The measured MMAD of the aerosol droplets was 2.1 micrometres.
This nebuliser monitors the breathing pattern to determine the aerosol pulse time required to deliver the pre-set dose of 2.5 or 5 micrograms iloprost.
The pre-set dose provided by the I-Neb AAD system is controlled by the medication chamber and in combination with a control disc. There are two different colour coded medication chambers. For each medication chamber there is a corresponding colour coded control disc:
For the 2.5 micrograms dose the medication chamber (350 microliter) with the red latch is used together with the red control disc.
For the 5 micrograms dose the medication chamber (650 microliter) with the purple coloured latch is used together with the purple control disc.
For each inhalation session with the I-Neb AAD, the content of one 1-ml ampoule of Ventavis, showing two coloured rings (white - yellow), will be transferred into the appropriate nebuliser medication chamber immediately before use.
Device Dose of iloprost at mouthpiece Estimated Inhalation time I-Neb AAD 2.5 micrograms 5 micrograms 3.2 min 6.5 min
Since the I-Neb nebuliser has been shown to produce an aerosol with slightly different physical characteristics to those of HaloLite, Prodose and VentaNeb devices and a faster delivery of the solution, patients stabilized on one nebuliser should not switch to another nebuliser without supervision by the treating physician.
The efficacy and tolerability of inhaled iloprost when administered with other nebulising systems, which provide different nebulisation characteristics of iloprost solution, have not been established.