In vitro dose characterization studies were performed to evaluate the delivery of VENTOLIN HFA via holding chambers with attached masks. The studies were conducted with 2 different holding chambers with masks (small and medium size). The in vitro study data when simulating patient breathing suggest that the dose of VENTOLIN HFA presented for inhalation via a valved holding chamber with mask will be comparable to the dose delivered in adults without a spacer and mask per kilogram of body weight (Table 2). However, clinical trials in children younger than 4 years described above suggest that either the optimal dose of VENTOLIN HFA has not been defined in this age-group or VENTOLIN HFA is not effective in this age-group. The safety and effectiveness of VENTOLIN HFA administered with or without a spacer device in children younger than 4 years have not been demonstrated.
To use the inhaler, remove the mouthpiece cover. Place the mouthpiece inside your mouth. Do not bite the inhaler. Breathe out. Just after you start to breathe in, press down on the top button to release a “puff”. Breathe in deeply. Remove your finger from the button and remove your mouth from the mouthpiece. Hold your breath, but only for as long as this is comfortable. Wait about half a minute between puffs, if multiple puffs are necessary. Replace the mouthpiece cover right away to avoid dust and other debris entering the inhaler. You should stand up or sit up straight whilst using your ventolin inhaler. You can take your ventolin inhaler with or without food.
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