ONE-ALPHA INJECTION 2 MCG/ML [SIN06140P]

Product Info

ONE-ALPHA INJECTION 2 MCG/ML

[SIN06140P]

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.