Vitamine D3 Teva 25.000 IE, zachte capsules

Country: Belanda

Bahasa: Belanda

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

Bahan aktif:

CHOLECALCIFEROL 625 µg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 25000 IE/stuk

INN (Nama Antarabangsa):

CHOLECALCIFEROL 625 µg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 25000 IE/stuk

Borang farmaseutikal:

Capsule, zacht

Komposisi:

GELATINE (E 441) ; GLYCEROL (E 422) ; IJZEROXIDE GEEL (E 172) ; PHOSAL 53 MCT ; TITAANDIOXIDE (E 171) ; TOCOFEROL, DL-ALFA (E 307) ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD

Laluan pentadbiran:

Oraal gebruik

Tarikh kebenaran:

1900-01-01

Risalah maklumat

Cholecalciferol, NL/H/5389/001
pack size, 11.04.23
1
rvg 128280 EU PIL IB/003 met NL info-clean
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
VITAMINE D3 TEVA 25.000 IE, ZACHTE CAPSULES
Cholecalciferol (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 or pharmacist.
-
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
contains the active ingredient cholecalciferol (vitamin
D3) that regulates the
uptake and metabolism of calcium as well as the incorporation of
calcium in bone tissue.
is used for initial treatment of clinically relevant
vitamin D deficiency in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE :
−
if you are allergic to cholecalciferol or any of the other ingredients
of this medicine (listed in
section 6).
−
if you have hypercalcaemia (increased levels of calcium in the blood)
or hypercalciuria
(increased levels of calcium in the urine).
−
if you have kidney stones
−
if you have calcium deposits in your kidneys (nephrocalcinosis)
− if you have severe kidney impairment.
− if you are allergic to peanut or soya.
If any of the above applies to you, talk to your doctor or pharmacist
before taking .
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking

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Ciri produk

Cholecalciferol, NL/H/5389/001
pack size, 11.04.23
Rvg 128280 EU SPC IB/003 met NL info-clean
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAAM VAN HET GENEESMIDDEL
Vitamine D3 Teva 25.000 IE, zachte capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
25,000 IU capsules, soft
Each capsule contains 0.625 mg cholecalciferol (vitamin D3),
equivalent to 25,000 IU vitamin D3.
Excipient with known effect:
The capsules may contain trace amounts of soya lecithin (may contain
soya oil).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsule, soft.
Yellow, opaque, oval soft gelatin capsule with dimension of
approximately 9 mm x 6 mm.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Initial treatment of clinically relevant vitamin D deficiency in
adults (serum level <25 nmol/L
(<10 ng/mL)).
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.
Recommended dose:
25,000 IU every week.
After first month, lower doses may be considered.
Following this initial treatment, maintenance therapy may be required
with a dose determined
individually by the treating doctor.
Alternatively, national posology recommendations in treatment of
vitamin D deficiency can be
followed.
_Hepatic impairment _
No dose adjustment is required.
_Renal impairment _
must not be used in patients with severe renal
impairment.
Cholecalciferol, NL/H/5389/001
pack size, 11.04.23
Rvg 128280 EU SPC IB/003 met NL info-clean
_Paediatric population _
is not recommended for use in children and adolescents
under 18 years of age.
Method of administration
The capsules should be swallowed whole with water.
Patients should be advised to take preferably with a
meal.
4.3 CONTRAINDICATIONS
•
hypersens