Colecalciferol Sandoz 20.000 IE, zachte capsules

Pajjiż: Olanda

Lingwa: Olandiż

Sors: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ingredjent attiv:

CHOLECALCIFEROL ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL

INN (Isem Internazzjonali):

CHOLECALCIFEROL ; COMPOSITION equivalent to CHOLECALCIFEROL

Għamla farmaċewtika:

Capsule, zacht

Kompożizzjoni:

BUTYLHYDROXYTOLUEEN (E 321) ; GELATINE (E 441) ; GLYCEROL (E 422) ; IJZEROXIDE ROOD (E 172) ; TITAANDIOXIDE (E 171) ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD

Rotta amministrattiva:

Oraal gebruik

Data ta 'l-awtorizzazzjoni:

2022-10-05

Fuljett ta 'informazzjoni

Sandoz B.V.
Page 1/7
Colecalciferol Sandoz 20.000 IE, zachte capsules
RVG 129688
1313-v1
1.3.1.3 Bijsluiter
September 2022
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
Colecalciferol Sandoz 20.000 IE, zachte capsules
colecalciferol (Vitamin D3)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What {[Nationally completed name]} is and what it is used for
2.
What you need to know before you take {[Nationally completed name]}
3.
How to take {[Nationally completed name]}
4.
Possible side effects
5.
How to store {[Nationally completed name]}
6.
Contents of the pack and other information
1 .
WHAT {[NATIONALLY COMPLETED NAME]} IS AND WHAT IT IS USED FOR
{[Nationally completed name]} contains colecalciferol (vitamin D).
Vitamin D helps the body to
absorb calcium and enhances bone formation.
This medicine is recommended for the starting treatment of clinically
relevant vitamin D deficiency
(serum level < 25 nmol/L (<10 ng/mL)) in adults.
{[Nationally completed name]} is indicated in adults.
2 .
WHAT YOU NEED TO KNOW BEFORE YOU TAKE {[NATIONALLY COMPLETED NAME]}
DO NOT TAKE {[NATIONALLY COMPLETED NAME]}:
Sandoz B.V.
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Colecalciferol Sandoz 20.000 IE, zachte capsules
RVG 129688
1313-v1
1.3.1.3 Bijsluiter
September 2022
-
if you are allergic to cholecalciferol or any of the other ingredients
of this medicine (listed in section
6)
-
if you have high levels of calcium in your blood (hypercalcaemia) or
urine (hypercalciuria)
-
if you have severe kidney problems (severe renal impairment)
-
if you have high levels of vitamin D i

Karatteristiċi tal-prodott

Sandoz B.V.
Page 1/9
Colecalciferol Sandoz 20.000 IE, zachte capsules
RVG 129688
1311-v1
1.3.1.1 Samenvatting van de Productkenmerken
September 2022
1.
NAAM VAN HET GENEESMIDDEL
Colecalciferol Sandoz 20.000 IE, zachte capsules
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 0.5 mg colecalciferol (Vitamin D3),
equivalent to 20,000 IU.
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Soft capsule.
{[Nationally completed name] 20,000 IU soft capsules} are pink opaque,
size 3, oval soft capsules.
Capsule length is approximately 11.2 mm and width is approximately 6.4
mm.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Initial treatment of clinically relevant vitamin D deficiency (serum
level < 25 nmol/L (<10 ng/mL)) in
adults.
{[Nationally completed name]} 20,0000IU IU soft capsules are indicated
in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage must be determined individually by the treating doctor
depending on the extent of the
necessary vitamin D supplementation. The dose should be adjusted
dependent upon desirable serum
levels of 25- hydroxycolecalciferol (25(OH)D), severity of the disease
and patients response to
treatment.
The patient’s dietary habits should be carefully evaluated and
artificially added vitamin D content of
certain food types should be taken into consideration.
_The initial loading dose of in total 100,000 IU can be achieved by 1
capsule of 20,000IU /week for up _
_to 4-5 weeks _
Sandoz B.V.
Page 2/9
Colecalciferol Sandoz 20.000 IE, zachte capsules
RVG 129688
1311-v1
1.3.1.1 Samenvatting van de Productkenmerken
September 2022
After completion of this loading dose, a lower maintenance dose should
be considered, dependent
upon desirable serum levels of 25-hydroxycolecalciferol (25(OH)D), the
severity of the disease and
the patient’s response to treatment.
Alternatively, national posology recommendations in treatment of
vitamin D deficiency can be
followed.
_Special populations _
_Hepatic impairment _
No dose