Detremin 2000 IE Kapsel, mjuk

Country: সুইডেন

ভাষা: সুইডিশ

সূত্র: Läkemedelsverket (Medical Products Agency)

সক্রিয় উপাদান:

kolekalciferol

থেকে পাওয়া:

Renapharma AB

এটিসি কোড:

A11CC05

INN (International Name):

cholecalciferol

ডোজ:

2000 IE

ফার্মাসিউটিকাল ফর্ম:

Kapsel, mjuk

রচনা:

sorbitol Hjälpämne; glycerol Hjälpämne; kolekalciferol 50 mikrog Aktiv substans

প্রেসক্রিপশন টাইপ:

Receptbelagt

পণ্য সারাংশ:

Förpacknings: Burk, 90 kapslar; Burk, 250 kapslar

অনুমোদন অবস্থা:

Godkänd

অনুমোদন তারিখ:

2023-01-17

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE USER
DETREMIN, 2000 I.U. SOFT CAPSULE
cholecalciferol (vitamin D
3
)
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, pharmacist or
nurse. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
:
1. What Detremin is and what it is used for
2. What you need to know before you take Detremin
3. How to take Detremin
4. Possible side effects
5. How to store Detremin
6. Contents of the pack and other information
1.
WHAT DETREMIN IS AND WHAT IT IS USED FOR
Detremin soft capsule contains cholecalciferol (vitamin D
3
).
Detremin is used to treat vitamin D deficiency, in adults and
adolescents (children over 12 years).
Detremin is also used as prophylaxis and treatment of vitamin D
deficiency in malabsorption.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DETREMIN
DO NOT TAKE DETREMIN
-if you are allergic to vitamin D
3
or any of the other ingredients of this medicine (listed in section 6)
-if you have hypercalcemia (too high levels of calcium in the blood)
-if you have hypervitaminosis D (too high levels of vitamin D in the
blood)
Do not take this medicine together with calcium if you have severely
impaired renal function.
WARNINGS AND PRECAUTIONS
Do not take more Detremin than your doctor has prescribed, since over
dosage may occur. Do not
combine Detremin with other vitamin D containing products other than
the one your doctor has
prescribed.
Talk to your doctor, pharmacist or nurse before taking Detremin:
-if you have impaired renal function
-if you have or have had kidney stones
if you have renal calcification (calcification of the kidney)
-if you h

পণ্য বৈশিষ্ট্য

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Detremin, 2000 IU soft capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains cholecalciferol (vitamin D3) 2000 IU
(equivalent to 50 microgram vitamin
D3).
Excipient(s) with known effect:
Each capsule contains 8 mg of sorbitol (E420).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Soft capsule.
The soft capsule is clear, slightly yellow, in oval shape. Capsule
dimensions are
12 mm x 7 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of vitamin D deficiency, in adults and adolescents (children
≥12 years).
•
Prophylaxis and treatment of vitamin D deficiency in malabsorption
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Recommended dose
_Recommended dose for vitamin D deficiency:_
VITAMIN D STATUS
25(OH)D
NMOL/L*
DAILY DOSE
Deficiency
<25
1-2 CAPSULES
2000-4 000 IU
*Serum 25-hydroxycholecalciferol
The dose should be adjusted dependent upon serum levels of
25-hydroxycholecalciferol, the severity
of the disease, and the patient´s response to treatment. Measurement
of 25(OH)D, serum phosphate,
and serum calcium is recommended 1-3 months after treatment
initiation. When relevant,
2
measurements should also include serum albumin, serum ALP (alkaline
phosphatase), and serum
creatinine.
A regular daily dose of 2000 IU (one capsule) raises serum
25-hydroxycholecalciferol (25(OH)D) in
average by approximately 50 nmol/l within 4-5 months in adults.
The dose in adults and adolescents should not exceed 4000 IU (2
capsules) per day.
After initial correction of the vitamin D deficit for 3 - 6 months,
the dose should be adjusted
to a lower maintenance dose. The dose, treatment duration and the
necessity of further
monitoring shall be individualized, guided by the diagnosis, the
severity of the disease and the
patient’s response to treatment.
_Treatment of vitamin D deficiency in malabsorption:_
1 capsule per day. The dose may be adjusted up to 5 capsules per day
under monitoring.