D-CURE ORAL SOLUTION 25000IU

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CHOLECALCIFEROL

Available from:

HYPHENS PHARMA PTE. LTD.

ATC code:

A11CC05

Pharmaceutical form:

SOLUTION

Composition:

CHOLECALCIFEROL 25000IU

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

SMB Technology S.A.

Authorization status:

ACTIVE

Authorization date:

2017-06-05

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Cholecalciferol (D-Cure) 25,000 IU oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution (1 single-dose oral solution in ampoule) contains 0.625
mg cholecalciferol, equivalent to
25,000 IU vitamin D.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral solution
Clear, slightly yellow, oily liquid with an orange odour
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Indicated for 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
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 6 weeks (followed by maintenance therapy of 400-1000 IU/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 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 6-8 weeks, 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 be