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Section 2: Addition of new size - 1ml ampoule containing 10 micrograms of iloprost
Section 4.2: Change in description of ampoule ie from one 2-ml ampoule of Ventavis to one ampoule containing 2ml of Ventavis.
Addition of coloured rings to one ampoule size.
Insertion of text re I-Neb AAD System as follows - The I-Neb 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 nebluliser has also been shown to be suitable for the administration of Ventavis. The measured MMAD of the aerosol droplets was 2.1µm. This nebuliser monitors the breathing pattern to determine the aerosol pulse time required to deliver the pre-set dose of 2.5 or 5µg iloprost. The pre-set dose provided by the I-Neb AAD system is controlled by the medication chamber 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 2.5µg dose the medication chamber (350µl) with the red latch is used together with the red control disc. For the 5µg dose the medication chamber (650µl) 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 three coloured rings (pink - red - red), will be transferred into the appropriate nebuliser medication chamber immediately before use.
(Table inserted). 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, patients stabilized on one nebuliser should not switch to another nebuliser without supervision by the treating physician.
Section 4.8: Additional undesirable effect under cardiovascular disorders - dizziness related to hypotension and under musculoskeletal disorders - pain in jaw.
Insertion of new paragraph - Adverse events in healthy volunteers - In a randomized placebo-controlled study in 160 healthy volunteers, inhaled doses of iloprost solution were given either with a fixed dose of 2.5mcg iloprost 6 times daily (total daily dose of 15mcg), or beginning with 5.0mcg and increasing up to 20mcg or the highest tolerated dose for a total of 6 dose inhalations (total daily dose of 70mcg). In the fixed dose group of 2.5mcg per inhalation chest pain or chest discomfort (32.5%), pharyngolaryngeal pain, or throat irritation (22.5%) and nausea (7.5%) (all non-serious and mild in intensity) occurred more frequently in comparison with the adverse events obtained from the placebo controlled phase II and III studies in patients with doses of 2.5mcg or 5mcg per inhalation. Five volunteers were unable to increase the dose up to 20mcg per inhalation because of mild to moderate transient chest pain or chest discomfort, usually accompanied by headache, dizziness and nausea.
Section 6.5: Nature & contents of container -Addition of new text: 1-ml ampoules, colourless, glass type I, containing 1ml nebuliser solution , ring coded with three coloured rings (pink-red-red).
Addition of ring coding to 3-ml ampoules - ring coded with two coloured rings (white-pink). 1ml nebuliser solution - packages containg 30 or 168 ampoules. 2ml nebuliser solution - packages containing 30, 100 or 300 ampoules. Not all pack sizes may be marketed.
Section 8: Addition of 2 MA numbers - EU/1/03/255/004 & 005
Section 10: Revision date amended from 5 September 2005 to 8 June 2006
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