Cholecalciferol Pharmemma 1.000 IE, zachte capsules

দেশ: নেদারল্যান্ডস

ভাষা: ডাচ

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

সক্রিয় উপাদান:

CHOLECALCIFEROL 25 µg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 1000 IE/stuk

থেকে পাওয়া:

Pharmemma Limited Unit 2, Ashbourne Manufacturing Park A84 KH58 ASHBOURNE (IERLAND)

INN (আন্তর্জাতিক নাম):

CHOLECALCIFEROL 25 µg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 1000 IE/stuk

ফার্মাসিউটিকাল ফর্ম:

Capsule, zacht

রচনা:

BRILJANTBLAUW FCF (E 133) ; CHINOLINEGEEL (E 104) ; GELATINE (E 441) ; GLYCEROL (E 422) ; SORBITOL VLOEIBAAR, GEDEELTELIJK GEDEHYDRATEERD ; TOCOFEROL, DL-ALFA ACETAAT ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD

প্রশাসন রুট:

Oraal gebruik

অনুমোদন তারিখ:

1900-01-01

তথ্য লিফলেট

NL/H/5338/001-003/IA/001/G
1
PACKAGE LEAFLET
NL/H/5338/001-003/IA/001/G
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
Cholecalciferol Pharmemma 1.000 IE, zachte capsules
Cholecalciferol
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 Cholecalciferol Pharmemma Capsules are and what they are used for
2.
What you need to know before you take Cholecalciferol Pharmemma
Capsules
3.
How to take Cholecalciferol Pharmemma Capsules
4.
Possible side effects
5.
How to store Cholecalciferol Pharmemma Capsules
6.
Contents of the pack and other information
1.
WHAT CHOLECALCIFEROL PHARMEMMA CAPSULES ARE AND WHAT THEY ARE USED FOR
The active substance of Cholecalciferol Pharmemma Capsules is vitamin
D3. Vitamin D helps the body
to absorb calcium and enhances bone formation.
_ _
This medicine is recommended in the following cases:
•
To prevent vitamin D deficiency in adults.
•
To treat vitamin D deficiency in adolescents and adults.
Vitamin D deficiency may occur when your diet or lifestyle does not
provide you enough
vitamin D or when your body requires more vitamin D.
•
For certain bone conditions, such as conditions that affect bone
development (osteomalacia),
thinning of the bone (osteoporosis), when it will be given to you with
other medicines.
Cholecalciferol Pharmemma Capsules are used in adults and the elderly
and adolescents.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHOLECALCIFEROL PHARMEMMA
CAPSULES
DO NOT TAKE CHOLECALCIFEROL PHARMEMMA CAPSULES:
-
if you are allergic to cholecalciferol (vitamin D)

পণ্য বৈশিষ্ট্য

NL/H/5338/001-003/IB/005
1
SUMMARY OF PRODUCT CHARACTERISTICS
NL/H/5338/001-003/IB/005
2
PRODUCT SUMMARY
1
N
AME OF THE
M
EDICINAL
P
RODUCT
Cholecalciferol Pharmemma 1.000 IE, zachte capsules
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Each capsule contains:
25 micrograms Cholecalciferol (vitamin D3), equivalent to 1,000 IU
Excipient(s) with known effect:
Each capsule also contains 16.5 milligrams of sorbitol.
For the full list of excipients, see section 6.1.
3
P
HARMACEUTICAL
F
ORM
Soft capsule
Green coloured clear transparent round shaped gelatin capsule with a
clear, colourless liquid fill with
approximate dimensions 7.36 mm x 6.27 mm.
4.
C
LINICAL
P
ARTICULARS
4.1 THERAPEUTIC INDICATIONS
_ _
Treatment of Vitamin D deficiency (serum 25(OH)D < 25 nmol/l) in
adults, the elderly and
adolescents.
Prevention of vitamin D deficiency in high-risk patients in adults and
the elderly.
As an adjunct to specific therapy for osteoporosis in patients with
vitamin D deficiency or at risk of
vitamin D insufficiency.
NL/H/5338/001-003/IB/005
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
Dose should be established on an individual basis depending on the
extent of the necessary vitamin D
supplementation. Cholecalciferol Pharmemma 1,000 IU capsules are
suitable for daily vitamin D
supplementation. Dosage should be established by a physician.
_ _
_Osteomalacia in adults:_
The dosage should be established by the treating physician. Certain
populations are at high risk of vitamin D deficiency, and may require
higher doses and monitoring of
serum 25(OH)D.
_ _
_Osteoporosis: _
For the adjunct therapy of osteoporosis a daily
doses equivalent of 2,000 IU vitamin D should be considered in fragile
elderly patients who are at
particular risk of falls and fractures. Recommended dose
Cholecalciferol Pharmemma 1,000 IU soft
capsules: 2 capsules/daily. Patients should receive supplemental
calcium if intake from diet is
inadequate.
_Vitamin D deficiency (serum levels < 25 nmol/l or < 10 ng/ml) in
adults and the elderly: _
800