Colecalciferol 1A Pharma 50.000 IE, zachte capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

CHOLECALCIFEROL 1,25 mg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 50000 IE/stuk

INN (Algemene Internationale Benaming):

CHOLECALCIFEROL 1,25 mg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 50000 IE/stuk

farmaceutische vorm:

Capsule, zacht

Samenstelling:

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

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

Sandoz B.V.
Page 1/7
Colecalciferol 1A Pharma 25.000 IE/ 50.000 IE, zachte
capsules
RVG 128774-5
1313-v1
1.3.1.3 Bijsluiter
September 2022
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
Colecalciferol 1A Pharma 25.000 IE, zachte capsules
Colecalciferol 1A Pharma 50.000 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.
Page 2/7
Colecalciferol 1A Pharma 25.000 IE/ 50.000 IE, zachte
capsules
RVG 128774-5
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 se

Productkenmerken

Sandoz B.V.
Page 1/9
Colecalciferol 1A Pharma 25000 IE, 50000 IE, zachte
capsules
RVG 128774-5
1311-v1b
1.3.1.1 Samenvatting van de Productkenmerken
Okotober 2022
1.
NAAM VAN HET GENEESMIDDEL
Colecalciferol 1A Pharma 25.000 IE, zachte capsules
Colecalciferol 1A Pharma 50.000 IE, zachte capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 0.625 mg colecalciferol (Vitamin D3),
equivalent to 25,000 IU.
Each soft capsule contains 1.25 mg colecalciferol (Vitamin D3),
equivalent to 50,000 IU.
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Soft capsule.
{[Nationally completed name] 25,000 IU soft capsules} soft capsules
are white opaque, size 3, oval
soft capsules. Capsule length is approximately 11.3 mm and width is
approximately 6.9 mm.
{[Nationally completed name] 50,000 IU soft capsules} are red opaque,
size 6, oval soft capsules.
Capsule length is approximately 13.5 mm and width is approximately 8.4
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]} 25,000IU and 50,000 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.
Sandoz B.V.
Page 2/9
Colecalciferol 1A Pharma 25000 IE, 50000 IE, zachte
capsules
RVG 128774-5
1311-v1b
1.3.1.1 Samenvatting van de Productkenmerken
Okotober 2022
_The initial loading dose of in total 100,000 IU can be achieved by
EITHER, 1 capsule of 25,000IU _
_/week for up to 4 weeks OR 1 to 2 capsules