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ONE-ALPHA Capsules (2017)

Active ingredients: Alfacalcidol

Product Name and Form

One-Alpha 1 microgram soft capsules.

One-Alpha 0.25 microgram soft capsules.

One-Alpha 0.5 microgram soft capsules.

Pharmaceutical form

One-Alpha 1 microgram soft capsules: Brown, egg-shaped soft gelatin capsules, holding 0.1 g oily solution.

One-Alpha 0.25 microgram soft capsules: Cream-coloured, egg-shaped soft gelatin capsules, holding 0.1 g oily solution.

One-Alpha 0.5 microgram soft capsules: Reddish, egg-shaped soft gelatin capsules, holding 0.1 g oily solution.

Qualitative and Quantitative Composition

Each capsule contains 1 microgram of alfacalcidol.

Each capsule contains 0.25 micrograms of alfacalcidol.

Each capsule contains 0.5 micrograms of alfacalcidol.

Excipient with known effect: Sesame oil.

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

One-Alpha1 microgram soft capsules:

Sesame oil
All-rac-α-tocopherol
Gelatine
Glycerol
Potassium sorbate
Black iron oxide
Red iron oxide

One-Alpha0.25 microgram soft capsules:

Sesame oil
All-rac-α-tocopherol
Gelatin
Glycerol
Potassium sorbate
Titanium dioxide

One-Alpha0.5 microgram soft capsules:

Sesame oil
All-rac-α-tocopherol
Gelatin
Glycerol
Potassium sorbate
Red iron oxide
Titanium dioxide

Pack sizes and Marketing

PVC/AL blister of 30 (OP), with polyamide-coated aluminium cover.

Marketing authorization holder
Authorization dates

LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK

Date of first authorisation:

One-Alpha 1 microgram soft capsules: 26 January 1978
One-Alpha 0.25 microgram soft capsules: 25 January 1978
One-Alpha 0.5 microgram soft capsules: 22 September 1999

Date of latest renewal:

One-Alpha 1 microgram soft capsules: 7 February 2004
One-Alpha 0.25 microgram soft capsules: 8 November 2006
One-Alpha 0.5 microgram soft capsules: 21 September 2004

Marketing authorization number:

One-Alpha 1 microgram soft capsules: PL 00043/0050
One-Alpha 0.25 microgram soft capsules: PL 00043/0052
One-Alpha 0.5 microgram soft capsules: PL 00043/0206