Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Pharmaxis Europe Limited, 108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Ireland
Osmohale inhalation powder, hard capsule.
| Pharmaceutical Form |
|---|
|
Inhalation powder, hard capsules. The powder is white or almost white. The empty capsule is clear, printed with two white bands. The capsule containing 5 mg is half white, half clear, marked 5 mg. The capsule containing 10 mg is half yellow, half clear, marked 10 mg. The capsule containing 20 mg is half pink, half clear, marked 20 mg. Capsules containing 40 mg are half red, half clear, marked 40 mg. |
1 capsule contains 0 mg, 5 mg, 10 mg, 20 mg or 40 mg mannitol.
The delivered dose from each of the 5, 10, 20 and 40 mg capsules is approximately 3.4, 7.7, 16.5 and 34.1 mg, respectively.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Mannitol |
Mannitol is a naturally occurring sugar alcohol used clinically primarily for its osmotic diuretic properties. |
| List of Excipients |
|---|
|
None. |
Capsules are packed in Aluminium/Aluminium blisters.
1 diagnostic kit consists of:
1 empty capsule
1 capsule containing 5 mg mannitol
1 capsule containing 10 mg mannitol
1 capsule containing 20 mg mannitol
15 capsules containing 40 mg mannitol
1 inhaler made of styrene plastics
Pharmaxis Europe Limited, 108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Ireland
PL 50608/0001
Date of latest renewal: 20 October 2011
| Drug | Countries | |
|---|---|---|
| OSMOHALE | Estonia, Spain, Ireland, United Kingdom |
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