D-CURE 25000IU ORAL SOLUTION

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Δραστική ουσία:

CHOLECALCIFEROL (VITAMIN D3)

Διαθέσιμο από:

HYPHENS PHARMA SDN. BHD.

INN (Διεθνής Όνομα):

CHOLECALCIFEROL (VITAMIN D3)

Μονάδες σε πακέτο:

4 x 1mL Ampoules

Κατασκευάζεται από:

SMB TECHNOLOGY S.A.

Φύλλο οδηγιών χρήσης

D-CURE 25,000 IU ORAL SOLUTION IN AMPOULE
_Consumer Medication Information Leaflet (RiMUP)_
Cholecalciferol
1
WHAT IS IN THIS LEAFLET
-
What
Cholecalciferol
(D-cure)
is
used for
-
How
Cholecalciferol
(D-cure)
works
-
Before you use Cholecalciferol (D-
cure)
-
How
to
use
Cholecalciferol
(D-
cure)
-
While
you
are
using
Cholecalciferol (D-cure)
-
Side effects
-
Storage
and
disposal
of
Cholecalciferol (D-cure)
-
Product description
-
Manufacturer and product
registration holder
-
Date of revision
WHAT
CHOLECALCIFEROL
(D-CURE)
IS
USED FOR
Cholecalciferol
(D-cure)
25,000IU
Oral Solution is a
vitamin product
containing
cholecalciferol
(equivalent
to
vitamin
D
3
).
Vitamin
D
can
be
found in some
foods
and
also
produced
by
the
body
when
skin
is
exposed
to
sunlight.
Vitamin
D
helps
the
kidneys
and
intestine
absorb
calcium
and
it
helps
build
bones
[refer
to
section
Before
you
take
Cholecalciferol (D-cure)].
Cholecalciferol
(D-cure)
25,000IU
Oral Solution is
used:
-
For
prevention
of
vitamin
D
deficiency when there is significant
risk of deficiency or/and increased
demand for vitamin D
-
With other medicines to treat certain
bone conditions, such as thinning of
the bone (osteoporosis)
-
To treat vitamin D deficiency that
has
been
confirmed
by
laboratory
tests
HOW
CHOLECALCIFEROL
(D-CURE)
WORKS
In its biologically active form
Vitamin D, stimulates intestinal
calcium absorption, incorporation of
calcium into the bone, and release of
calcium fro m bone tissue. In the
small intestine it promotes rapid and
delayed calcium uptake. The passive
and active transport of phosphate
is
also stimulated. In the kidney, it
inhibits
the
excretion
of
calcium
and
phosphate. The
production
of
parathyroid
hormone
(PTH)
in
the
parathyroids
is
inhibited
directly by
the biologically active
form of vitamin D3. PTH secretion
is
inhibited
additionally
by
the
increased
calcium
uptake
in
the
small intestine under the influence
of biologically active vitamin D.
BEFORE YOU USE CHOLECALCIFEROL (D-
CURE)
WHEN YOU MUST NOT USE IT
Do not take Cholecalciferol

Αρχείο Π.Χ.Π.

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