Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Diurnal Europe B.V., Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, The Netherlands, Tel. +31 (0)20 6615 072, info@diurnal.co.uk
Alkindi 0.5 mg granules in capsules for opening.
Alkindi 1 mg granules in capsules for opening.
Alkindi 2 mg granules in capsules for opening.
Alkindi 5 mg granules in capsules for opening.
| Pharmaceutical Form |
|---|
|
Granules in capsules for opening. The granules are white to off-white and contained in a transparent colourless (size 00el) hard capsule. Alkindi 0.5 mg granules in capsules for opening: The capsule is printed with “INF-0.5” in red ink. Alkindi 1 mg granules in capsules for opening: The capsule is printed with “INF-1.0” in blue ink. Alkindi 2 mg granules in capsules for opening: The capsule is printed with “INF-2.0” in green ink. Alkindi 5 mg granules in capsules for opening: The capsule is printed with “INF-5.0” in grey ink. |
Alkindi 0.5 mg granules in capsules for opening: Each capsule contains 0.5 mg hydrocortisone.
Alkindi 1 mg granules in capsules for opening: Each capsule contains 1 mg hydrocortisone.
Alkindi 2 mg granules in capsules for opening: Each capsule contains 2 mg hydrocortisone.
Alkindi 5 mg granules in capsules for opening: Each capsule contains 5 mg hydrocortisone.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Hydrocortisone |
Hydrocortisone is the main glucocorticoid secreted by the adrenal cortex. Hydrocortisone is an anti-inflammatory steroid. Its anti-inflammatory action is due to reduction in the vascular component of the inflammatory response and reduction in the formation of inflammatory fluid and cellular exudates. |
| List of Excipients | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Granules: Microcrystalline cellulose Printing ink:
|
Hard capsule for opening, containing a single dose of granules. The capsules are provided in high-density polyethylene bottles with polypropylene closure with integrated desiccant.
Pack sizes: 1 bottle containing 50 capsules.
Diurnal Europe B.V., Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, The Netherlands, Tel. +31 (0)20 6615 072, info@diurnal.co.uk
Alkindi 0.5 mg granules in capsules for opening: EU/1/17/1260/001
Alkindi 1 mg granules in capsules for opening: EU/1/17/1260/002
Alkindi 2 mg granules in capsules for opening: EU/1/17/1260/003
Alkindi 5 mg granules in capsules for opening: EU/1/17/1260/004
Date of first authorisation: 09 February 2018
| Drug | Countries | |
|---|---|---|
| ALKINDI | Austria, Estonia, Croatia, Ireland, Israel, Lithuania, Poland, Romania, United Kingdom |
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