Fultium 67 IE/droppe Orala droppar, lösning

Valsts: Zviedrija

Valoda: zviedru

Klimata pārmaiņas: Läkemedelsverket (Medical Products Agency)

Aktīvā sastāvdaļa:

kolekalciferol

Pieejams no:

STADA Arzneimittel AG

ATĶ kods:

A11CC05

SNN (starptautisko nepatentēto nosaukumu):

cholecalciferol

Deva:

67 IE/droppe

Zāļu forma:

Orala droppar, lösning

Kompozīcija:

kolekalciferol 1,67 mikrog Aktiv substans

Receptes veids:

Receptbelagt

Produktu pārskats:

Förpacknings: Flaska, 1025 droppar (25 ml)

Autorizācija statuss:

Godkänd

Autorizācija datums:

2017-05-22

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FULTIUM 2 740 IU/ML ORAL DROPS, SOLUTION
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fultium is and what it is used for
2.
What you need to know before you take Fultium
3.
How to take Fultium
4.
Possible side effects
5.
How to store Fultium
6.
Contents of the pack and other information
1.
WHAT FULTIUM IS AND WHAT IT IS USED FOR
Fultium contains the active ingredient cholecalciferol (vitamin D
3
):
Vitamin D
3
regulates the uptake and metabolism of calcium as well as the
incorporation of calcium in
bone tissue.
Fultium
is used to prevent and treat vitamin D
3
deficiency in adults, adolescents and children with an
identified risk of vitamin D
3
deficiency.
Fultium
can also be used
as an adjunct to specific bone loss medication.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FULTIUM
DO NOT TAKE FULTIUM
-
if you are allergic to vitamin D or any of the other ingredients of
this medicine (listed in section
6)
-
if you have high levels of vitamin D in your blood (hypervitaminosis
D)
-
if you have high blood levels of calcium (hypercalcaemia) or high
urine levels of calcium
(hypercalciuria)
-
if you have kidney stones and/or nephrocalcinosis (renal
calcification) or serious kidney
problems.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Fultium
-
if you have kidney damage or disease. Your doctor will need to measure
the levels of calcium in
your blood or urine
-
if you are being treated for heart disease

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fultium 2 740 IU/ml Oral Drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml oral solution contains:
Cholecalciferol (vitamin D3, equivalent to 2 740 IU) 68.5 micrograms.
1 drop contains:
Cholecalciferol (vitamin D3, equivalent to 67 IU) 1.67 micrograms.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral drops, solution
Clear, colourless to slightly yellow oil.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention and treatment of vitamin D deficiency in adults,
adolescents and children with an identified
risk.
In addition to specific therapy for osteoporosis in patients with
vitamin D deficiency, preferably in
combination with calcium.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
_Prevention of vitamin D deficiency and osteoporosis:_
Recommended dose is 6-12 drops (400 IU – 800 IU) per day.
_Treatment of vitamin D deficiency:_
12 drops (800IU) per day. Higher doses should be adjusted dependent
upon desirable serum levels of
25-hydroxycolecalciferol (25(OH)D), the severity of the disease and
the patient´s response to
treatment.
The daily dose should not exceed 4,000 IU (60 drops).
Paediatric population
_Prevention:_
Children (0 up to 11 years old) with an identified risk: 6 drops (400
IU) per day
Adolescents (12 years to 18 years) with an identified risk: 6-12 drops
(400 IU – 800 IU) per day.
_Treatment:_
In vitamin D deficiency, the dose should be adjusted dependent upon
desirable serum levels of 25-
hydroxycolecalciferol (25(OH)D), the severity of the disease and the
patient´s response to treatment.
The daily dose should not exceed 1000 IU per day for infants <1 years,
2000 IU per day for children
1-10 years and 4000 IU per day for adolescents >11 years.
Alternatively, national posology recommendations in prevention and
treatment of vitamin D
deficiency can be followed.
Where higher doses are required, higher strength products may be more
appropriate to deliver the
dose.
_Dosag