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ONE-ALPHA CAPSULE 0.25 MCG [SIN05972P]

Active ingredients: ONE-ALPHA CAPSULE 0.25 MCG

Last updated 26 October 2025

Product Info

ONE-ALPHA CAPSULE 0.25 MCG

[SIN05972P]

Product information

Active Ingredient and Strength

ALFACALCIDOL - 0.25 MCG

Dosage Form

CAPSULE, LIQUID FILLED

Manufacturer and Country

LEO PHARMA A/S - DENMARK
SWISS CAPS AG (ENCAPSULATION SITE) - SWITZERLAND

Registration Number

SIN05972P

Licence Holder

ZUELLIG PHARMA PTE. LTD.

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

A11CC03

4.1 Therapeutic indications
Diseases caused by disturbances in the calcium metabolism in consequence of reduced endogenous production of 1.25‐dihydroxyvitamin D3. Renal osteodystrophy, postoperative or idiopathic hypo-parathyroidism, pseudohypoparathyroidism, as an adjunct to the management of tertiary hyperparathyroidism, vitamin D‐resistant rickets or osteomalacia, vitamin D‐dependent rickets, neonatal hypocalcaemia or rickets, malabsorption of calcium, osteoporosis, malabsorptive and nutritional rickets, and osteomalacia.

4.2 Posology and method of administration
Individual dosage under thorough control of serum calcium.

Adults and children over 20 kg: Initially 1 microgram daily
Maintenance dose: Usually 0.25 – 2 micrograms daily
Children (>1 month) under 20 kg: Initially 0.05 microgram/kg/day
One-Alpha® drops to neonates (<1 month): 0.1 micrograms/kg/day.
One-Alpha® drops must be taken orally.
One-Alpha® capsules must be swallowed whole.
One-Alpha® solution for injection is intended for intravenous injection and should be injected slowly.
Must be shaken before use.

Elderly: There is no specific clinical experience in the treatment of elderly patients. Special attention is not deemed necessary. Reduced renal function: See section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Reduced liver function: With severe liver insufficiency the hydroxylation of 1α-hydroxy vitamin D3 to 1.25 dihydroxy vitamin D3 may be reduced, and the intestinal absorption may be reduced because of decreased enterohepatic circulation. A higher dosage may be necessary.

One-Alpha® can be given as an i.v. injection following each haemodialysis. The injection should be administered into the return line from the haemodialysis machine at the end of each dialysis. The initial dosage for adults is 1 microgram per dialysis. The maximum dose recommended is 6 micrograms per dialysis and not more than 12 micrograms per week.

Food intake: It is not known whether the effect of One-Alpha® is affected if taken together with food.

4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
Hypercalcaemia.