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Colecalciferol
Jenson Pharmaceutical Services Ltd
A11CC05
Colecalciferol
68.5 micrograms/ml vitamin D3
Oral drops, solution
Oral use
Pack size: 25 ml
POM - Prescription Only Medicine
Jenson Pharmaceutical Services Ltd
Vitamin D and analogues
It is used for the prevention and treatment of vitamin D deficiency and as an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency
Authorised
2015-06-05
FultiumD3 Drops Summary of Product Characteristics Updated 15Jun2015 | Internis Pharmaceuticals Ltd 1. Name of the medicinal product FultiumD3 Drops 2. Qualitative and quantitative composition 1 ml oral solution contains: 2740 IU Colecalciferol (equivalent to 68.5 micrograms/ml vitamin D3) 3 drops contains 200 IU Colecalciferol (vitamin D3) For the full list of excipients, see section 6.1. 3. Pharmaceutical form Oral drops, solution Clear, colourless to slightly yellow oil. 4. Clinical particulars 4.1 Therapeutic indications The prevention and treatment of vitamin D deficiency. As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency. 4.2 Posology and method of administration Posology 3 drops contains 200 IU vitamin D. 1 ml is equivalent to 41 drops. Treatment vitamin D deficiency should be for up to 12 weeks dependent upon the severity of the disease and the patient's response to treatment, followed by the appropriate long term maintenance therapy. Paediatric posology Infants aged 0 up to 2 years Treatment of vitamin D deficiency 6 – 15 drops (400 – 1,000 IU) daily. Long term maintenance therapy following treatment of deficiency AND Prevention of vitamin D deficiency 3 – 15 drops (200 – 1,000 IU) daily. Children aged 2 years to 11 years Treatment of vitamin D deficiency 6 – 30 drops (400 – 2,000 IU) daily. Long term maintenance therapy following treatment of deficiency AND Prevention of vitamin D deficiency 6 – 15 drops (400 – 1,000 IU) daily. Adolescents aged 12 years to 18 years Treatment of vitamin D deficiency 6 – 60 drops (400 – 4,000 IU) daily. Long term maintenance therapy following treatment of deficiency AND Prevention of vitamin D deficiency 6 – 24 dr Lue koko asiakirja