on-vent adaptor
| 16:25 Feb 12, 2009 |
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| English to Polish translations [Non-PRO] Medical - Medical: Pharmaceuticals | |||||||
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2 hrs peer agreement (net): +2 |
| Reference Reference information: Findings "on-vent" = on ventilation/requiring breathing assistance "off-vent" = off ventilation/not requiring breathing assistance http://209.85.229.132/search?q=cache:NHYm_hRFQMYJ:www.bioriv... Amikacin Inhale is a unique drug-device combination, being developed by Bayer HealthCare in cooperation with Nektar Therapeutics, combining a special liquid formulation of the aminoglycoside antibiotic amikacin with Nektar Therapeutics’ proprietary Liquid Pulmonary Technology (LPTTM), designed to deliver amikacin deep into the infected lungs. The device can be integrated into mechanical ventilation systems and can also be used as a handheld ‘off-vent’ device for patients no longer requiring breathing assistance. This allows for a unique full course of drug therapy in critically ill patients with Gram-negative pneumonia. ‘Gram-negative pneumonia’ refers to pneumonia caused by a laboratory-defined group of pathogens, the Gram-negative bacteria. These account for a substantial proportion, if not the majority of pneumonias in intensive care units (ICUs). About Phase II Studies High Amikacin Lung Deposition in MVP (2) In the multi-center, randomized, double-blind, placebo-controlled Phase II study mechanically ventilated patients (MVP) received 400 mg doses of amikacin with Amikacin Inhale every 24 hours (n=24) or every 12 hours (n=21) for 7-14 days. Serial serum, tracheal aspirate and urine samples were collected on Day 3. Clinical parameters, such as Clinical Pulmonary Infection Score (CPIS), days on ventilator and intravenous antibiotic use were monitored. In another study healthy volunteers (n=14) inhaled a single dose of 400 mg of amikacin via the proprietary delivery system using the hand held adaptor. This was done to compare the lung doses between on-vent and hand-held adaptors using the same proprietary nebulizer. Mean peak tracheal aspirate of amikacin after Amikacin Inhale use every 12 hours was 16,212±3,675 μg/mL as compared to 14±4.2 μg/mL after intravenous administration (15mg/kg per day)(3). After Amikacin Inhale use, peak serum levels of amikacin were 3.2±0.5 μg/mL versus 47±4.2 μg/mL after intravenous administration. On average, 43 percent of the dose was delivered to the lungs using the hand-held system with a comparable low systemic exposure. The dose delivered to the lungs with the proprietary nebulizer is comparable between the on-vent and hand-held adaptors. |
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