Source: Υπουργείο Υγείας (CY) Revision Year: 2017 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Frenolyn 200 micrograms inhalation powder.
| Pharmaceutical Form |
|---|
|
Inhalation powder. Breath actuated metered dose dry powder, administrated with a Miat–Haler device. The device, Miat–Haler, consists of a light grey body with a dark brown screw closure, that when opened shows a light grey inhaler. |
Budesonide.
Each metered dose contains 200 micrograms of budesonide.
Excipient with known effect: lactose monohydrate. Each metered dose contains 2300 micrograms of lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Budesonide |
Budesonide is a glucocorticosteroid with a high local anti-inflammatory effect. At doses clinically equivalent to systemically acting glucocorticosteroids, budesonide gives significantly less HPA axis suppression and has a lower impact on inflammatory markers. |
| List of Excipients |
|---|
|
Frenolyn also contains lactose monohydrate. |
Miat–Haler:
Polypropylene container consisting of a brown screw cap and a grey case. Removal of the cap reveals the body of the inhaler, consisting of a polyacetal (POM) mouthpiece, acrilonitrile butadiene styrene (ABS) body, a polybutylene terephthalate (PBT) dosing mechanism, and the immediate drug container made of methacrylate butadiene styrene (MABS) and sealed with a low density polyethylene (LDPE) stopper.
The grey case also contains a desiccant pill, with a symbol indicating not for oral ingestion. This should not be removed.
Each Miat–Haler is packed into a polyester – aluminium – polyethylene strip, and packaged, with a patient information leaflet, in a card carton.
Miat–Haler budesonide 200 is available in devices with 100 doses, or 200 doses.
Cartons containing one inhaler, or three inhalers are available.
Not all pack sizes may be marketed.
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
20291
29.01.2008 / 02.02.2015
| Drug | Countries | |
|---|---|---|
| FRENOLYN | Cyprus, Malta, Romania, Singapore |
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