ONE-ALPHA Solution for injection (2017)
Active ingredients: Alfacalcidol
Product Name and Form
One-Alpha 2 microgram/ml injection.
Solution for injection.
Clear, colourless liquid in 1 ml one-point-cut amber glass ampoule.
Qualitative and Quantitative Composition
Alfacalcidol 2 micrograms/ml.
Excipients with known effect: Ethanol, sodium citrate.
For the full list of excipients, see section 6.1.
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.
Water for injection
Pack sizes and Marketing
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
Date of first authorisation: 22 July 1991
Date of latest renewal: 11 November 2005