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ONE-ALPHA Solution for injection (2017)

Active ingredients: Alfacalcidol

Product Name and Form

One-Alpha 2 microgram/ml injection.

Pharmaceutical form

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.

Chemical substance
Description

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
Ethanol
Sodium citrate
Propylene glycol
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.

Marketing authorization holder
Authorization dates

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

Marketing authorization number:

PL 00043/0183