ONE-ALPHA INJECTION 2 mcg/ml

ZUELLIG PHARMA PTE. LTD.

ZUELLIG PHARMA PTE. LTD.

Therapeutic

Prescription Only

INJECTION

**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.