Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK
One-Alpha 2 microgram/ml injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear, colourless liquid in 1 ml one-point-cut amber glass ampoule. |
Alfacalcidol 2 micrograms/ml.
Excipients with known effect: Ethanol, sodium citrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Alfacalcidol |
Alfacalcidol is Vitamin D-hormone analog (an active metabolite of Vitamin D), which performs important functions in regulation of the calcium balance and the bone metabolism and is activated by the enzyme 25-hydroxylase (converted rapidly in the liver to 1,25-dihydroxyvitamin D) for systemic and in osteoblasts for local D-hormone actions. |
| List of Excipients |
|---|
|
Citric acid |
10 × 0.5 ml amber glass ampoules.
10 × 1.0 ml amber glass ampoules.
Not all pack sizes may be marketed.
LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK
PL 00043/0183
Date of first authorisation: 22 July 1991
Date of latest renewal: 11 November 2005
| Drug | Countries | |
|---|---|---|
| ONE-ALPHA | Canada, Cyprus, Germany, Estonia, Hong Kong, Ireland, Lithuania, Malta, New Zealand, Romania, Singapore, United Kingdom, South Africa |
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