D-CURE Oral solution Ref.[116019] Active ingredients: Vitamin D3

Paediatrics

• Prevention of deficiency 0-1 years 25000 IU (1 single-dose oral solution in ampoule) every 8 weeks
• Prevention of deficiency 1-18 years 25000 IU (1 single-dose oral solution in ampoule) every 6 weeks
• Treatment of deficiency 0-18 years 25000 IU (1 single-dose oral solution in ampoule) once every 2 weeks for 6weeks (followed by maintenance therapy of 400-1000 IU/day)

Administration to children

In children, 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 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 IU/month (1 single-dose oral solution in ampoule)
• Treatment of vitamin D deficiency (<25 ng/ml) 50000 IU/week (2 single-dose oral solution in ampoule) for 6-8weeks, followed by maintenance therapy (1400-2000 IU/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 IU/month (1 single-dose oral solution in ampoule)

Administration to adults

D-Cure is an oral solution packaged in single-dose container. The content of the singledose 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. 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 sunscreens
• 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

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 D-Cure preferably with meal (see section 5.2 Pharmacokinetic properties - "Absorption").

See also section 6.6, Special precautions for handling and disposal.

Symptoms of overdose

Ergocalciferol (vitamin D2) and cholecalciferol (vitamin D3) have a relatively low therapeutic index. The threshold for vitamin D intoxication is between 40,000 and 100,000 IU daily for 1 to 2 months in adults with normal parathyroid function. Infants and small children may react sensitively to far lower concentrations. Therefore, it is warned against intake of vitamin D without medical supervision.

Overdose leads to increased serum and urinary phosphorus levels, as well as hypercalcaemic syndrome and consequently calcium deposits in the tissues and above all in the kidneys (nephrolithiasis, nephrocalcinosis) and the vessels.

Discontinue D-Cure when calcaemia exceeds 10.6 mg/dl (2.65 mmol/l) or if the calciuria exceeds 300 mg/24 hours in adults or 4-6 mg/kg/day in children.

Chronic overdosage may lead to vascular and organ calcification, as a result of hypercalcaemia. The symptoms of intoxication are little characteristic and manifest as nausea, vomiting, initially also diarrhoea, later constipation, loss of appetite, weariness, headache, muscle pain, joint pain, muscle weakness, persistent sleepiness, azotaemia, polydipsia and polyuria and, in the final stage, dehydration. Typical biochemical findings include hypercalcaemia, hypercalciuria, as well as increased serum 25 hydroxycholecalciferol concentrations.

Treatment of overdose

Symptoms of chronic vitamin D overdosage may require forced diuresis as well as administration of glucocorticoids or calcitonin.

Overdosage requires measures for treating the - often persisting and under certain circumstances lifethreatening - hypercalcaemia.

The first measure is to discontinue the vitamin D preparation; it takes several weeks to normalise hypercalcaemia caused by vitamin D intoxication.

Depending on the degree of hypercalcaemia, measures include a diet that is low in calcium or free of calcium, abundant liquid intake, increase of urinary excretion by means of the drug furosemide, as well as the administration of glucocorticoids and calcitonin.

If kidney function is adequate, calcium levels can be reliably lowered by infusions of isotonic sodium chloride solution (3-6 liters in 24 hours) with addition of furosemide and, in some circumstances, also 15 mg/kg body weight/hour sodium edetate accompanied by continuous calcium and ECG monitoring. In oligoanuria, in contrast, haemodialysis (calcium-free dialysate) is necessary.

No special antidote exists.

It is recommended to point out the symptoms of potential overdose to patients under chronic therapy with higher doses of vitamin D (nausea, vomiting, initially also diarrhoea, later constipation, anorexia, weariness, headache, muscle pain, joint pain, muscle weakness, persistent sleepiness, azotaemia, polydipsia and polyuria).

18 months.

Do not store above 30°C.

Store in the original package, in order to protect from light.

Transparent PVC/PVDC/PE ampoules.

Original Pack with 4 ampoules or 12 ampoules.

Not all pack sizes may be marketed.

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.