D-CURE ORAL SOLUTION 25000IU

SOLUTION

**4.2 Posology and method of administration** Paediatrics: - Prevention of deficiency 0–1 years 25000 international units (1 single-dose oral solution in ampoule) every 8 weeks - Prevention of deficiency 1–18 years 25000 international units (1 single-dose oral solution in ampoule) every 6 weeks - Treatment of deficiency 0–18 years 25000 international units (1 single-dose oral solution in ampoule) once every 2 weeks for 6 weeks (followed by maintenance therapy of 400–1000 international units/day) _Administration to children:_ In children, Cholecalciferol (D-Cure) can be mixed with a small amount of children's foods, yogurt, milk, cheese or other dairy products. The parents should be warned not to mix Cholecalciferol (D-Cure) into a bottle of milk or container of soft foods in case the child does not consume the whole portion, and does not receive the full dose. The parents should ensure that their child takes the entire dose. For children who are not breast-feeding, the prescribed dose should be administered with a meal. Adults: - Prevention of vitamin D deficiency 25000 international units/month (1 single-dose oral solution in ampoule) - Treatment of vitamin D deficiency (<25 ng/ml) 50000 international units/week (2 single-dose oral solution in ampoule) for 6–8 weeks, followed by maintenance therapy (1400–2000 international units/day may be required; follow-up 25(OH)D measurements should be made approximately three to four months after initiating maintenance therapy to confirm that the target level has been achieved) - As an adjunct to specific therapy for osteoporosis: 25000 international units/month (1 single-dose oral solution in ampoule) _Administration to adults:_ Cholecalciferol (D-Cure) is an oral solution packaged in single-dose container. The content of the single-dose oral solution (in ampoule) is to be emptied directly into the mouth and swallowed orally. To help the patient, the full content of the single-dose oral solution (in ampoule) may be emptied onto a spoon and taken orally. D-Cure can also be taken by mixing with a small amount of cold or lukewarm food immediately prior to use. Cholecalciferol (D-Cure) is only for oral use. Certain populations are at high risk of vitamin D deficiency, and may require higher doses and monitoring of serum 25(OH)D: - Institutionalised or hospitalised individuals - Dark skinned individuals - Individuals with limited effective sun exposure due to protective clothing or consistent use of sun screens - Obese individuals - Patients being evaluated for osteoporosis - Use of certain concomitant medications (e.g., anticonvulsant medications, glucocorticoids) - Patients with malabsorption, including inflammatory bowel disease and coeliac disease - Those recently treated for vitamin D deficiency, and requiring maintenance therapy Special populations _Renal impairment_ Cholecalciferol (D-Cure) should not be used in combination with calcium in patients with severe renal impairment. _Hepatic impairment_ No posology adjustment is required in patients with hepatic impairment. Pregnancy and breastfeeding: - The high strength formulation is not recommended Method of administration Patients should be advised to take Cholecalciferol (D-Cure) preferably with meal (see section 5.2 Pharmacokinetic properties – “Absorption” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). See also section 6.6, Special precautions for handling and disposal – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.