ZODORAY Capsule Ref.[50532] Active ingredients: Alfacalcidol

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2021  Publisher: Strides Pharma SA (Pty) Ltd., 106 16th Road, Building 2, Midrand, 1685

Product name and form

ZODORAY 0,25 µg capsules.

ZODORAY 0,5 µg capsules.

ZODORAY 1 µg capsules.

Pharmaceutical Form

ZODORAY 0,25 µg capsules: Reddish brown coloured, oval shaped soft gelatine capsules containing clear oily liquid.

ZODORAY 0,5 µg capsules: Light pink coloured, oval shaped soft gelatine capsules containing clear oily liquid.

ZODORAY 1 µg capsules: Pale yellow coloured, oval shaped soft gelatine capsules containing clear oily liquid.

Qualitative and quantitative composition

ZODORAY 0,25 µg capsules: Each capsule contains 0,25 µg alfacalcidol.

ZODORAY 0,5 µg capsules: Each capsule contains 0,50 µg alfacalcidol.

ZODORAY 1 µg capsules: Each capsule contains 1 µg alfacalcidol.

Excipient: Contains 98,7 mg arachis oil (peanut oil).

Contains sugar: Sorbitol 10 mg.

For 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

Anhydrous citric acid
All-rac-alpha-tocopherol (antioxidant)
Propyl gallate (antioxidant)
Anhydrous ethanol (1,0 % v/v)
Refined arachis oil (peanut oil)

Soft gelatine capsule shell:

Gelatine, glycerol
Partially dehydrated sorbitol liquid (anidrisorb)
Purified water
Medium chain triglyceride

Capsule colours:

For 1 µg Capsules: Titanium dioxide (E171) and ferric oxide yellow (E172).
For 0,5 µg Capsules: Titanium dioxide (E171) and ferric oxide red (E172).
For 0,25 µg Capsules: Titanium dioxide (E171), ferric oxide red (E172) and ferric oxide black (E172).

Warning(s): Contains refined peanut oil, sorbitol and ethanol (1,0 % v/v).

Pack sizes and marketing

White, opaque HDPE container with white opaque HDPE screw closure and induction sealing.

Pack sizes of 30’s, 50’s and 100’s.

Not all pack sizes may be marketed.

Marketing authorization holder

Strides Pharma SA (Pty) Ltd., 106 16th Road, Building 2, Midrand, 1685

Drugs

Drug Countries
ZODORAY South Africa
 
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