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.

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

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
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.

4.8 UNDESIRABLE EFFECTS
The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical studies and spontaneous reporting.
The most frequently reported undesirable effects are various skin reactions such as pruritus and rash, hypercalcaemia, gastrointestinal pain/discomfort and hyperphosphataemia.
Renal failure has been reported post-marketing.
Undesirable effects are listed by MedDRA system organ class (SOC) and the individual undesirable effects are listed starting with the most frequently reported one. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Very common ≥1/10
Common ≥1/100 to < 1/10
Uncommon ≥1/1,000 to <1/100
Rare ≥1/10,000 to <1/1,000
Very rare <1/10,000

Metabolism and nutrition disorders
Common: Hypercalcaemia
Hyperphosphatemia
Psychiatric disorders
Uncommon: Confusional state
Nervous system disorders
Uncommon: Headache
Rare: Dizziness
Gastrointestinal disorders
Common: Abdominal pain and discomfort
Uncommon: Diarrhoea
Vomiting
Constipation
Nausea
Skin and subcutaneous tissue disorders
Common: Rash*
Pruritus
*Various types of rash such as erythematous, maculo-papular and pustular have been reported
Musculoskeletal and connective tissue disorders
Uncommon: Myalgia
Renal and urinary disorders
Common: Hypercalciuria
Uncommon: Renal impairment (including acute renal failure)
Nephrolithiasis/Nephrocalcinosis
General disorders and administration site conditions
Uncommon: Fatigue/asthenia/malaise/Calcinosis

6.3 Special precautions for storage
Capsules
Protect from direct sunlight; store below 25 °C.
Drops
Keep bottle in outer carton to protect from direct sunlight; store at 2-8 °C.
Solution for injection
Keep ampoules in outer carton to protect from light; store at 2-8 °C.
Keep out of the reach of children