Colecalciferol Thame 10,000IU/ml Oral Solution

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Wirkstoff:

COLECALCIFEROL

Verfügbar ab:

Syri Pharma Limited Floor 0 1 WML, 1 Windmill Lane Dublin 2, D02 F206, Ireland

ATC-Code:

A11CC05

INN (Internationale Bezeichnung):

COLECALCIFEROL 1000 IU/ml

Darreichungsform:

ORAL SOLUTION

Zusammensetzung:

COLECALCIFEROL 1000 IU/ml

Verschreibungstyp:

POM

Therapiebereich:

VITAMINS

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2019-04-15

Gebrauchsinformation

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PACKAGE LEAFLET: INFORMATION FOR THE USER
COLECALCIFEROL THAME 10000 IU/ML ORAL SOLUTION
colecalciferol (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.
The name of your medicine is Colecalciferol Thame 10000 IU/ml Oral
Solution but it will be
referred to as Colecalciferol throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Colecalciferol is and what it is used for
2.
What you need to know before you take Colecalciferol
3.
How to take Colecalciferol
4.
Possible side effects
5.
How to store Colecalciferol
6.
Contents of the pack and other information
1. WHAT COLECALCIFEROL IS AND WHAT IT IS USED FOR
Colecalciferol oral solution contains the active substance called
colecalciferol (vitamin D
3
). Vitamin
D
3
can be found in some foods and is also produced by the body when skin
is exposed to sunlight.
Vitamin D
3
helps the kidneys and intestine absorb calcium and it helps build
bones. Vitamin D
3
deficiency is the predominant cause of rickets (defective
mineralisation of bones in children) and
osteomalacia (inadequate mineralisation of bones in adults).
Colecalciferol is used:
►
to prevent and treat vitamin D
3
deficiency in adults, adolescents and children with an identified
risk of vitamin D
3
deficiency
►
as an adjunct to specific bone loss medication.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COLECALCIFEROL
DO NOT TAKE COLECALCIFEROL IF:
►
You are allergic to colecalciferol (vitamin D
3
) or any of the other ingredients of this medicine
(listed in section 6)
►
You have high levels

Fachinformation

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Colecalciferol Thame 10000IU/ml Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Colecalciferol oral solution contains the active substance,
colecalciferol.
Each ml of oral solution contains 10000IU colecalciferol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
A clear, yellow coloured solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention and treatment of vitamin D deficiency in adults,
adolescents and children with an
identified risk.
As an adjunct to specific therapy for osteoporosis in patients with
vitamin D deficiency or at
risk of vitamin D insufficiency.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults:
_Prevention of vitamin D deficiency and osteoporosis:_
Recommended dose is 600 – 800 IU per day (0.06-0.08ml).
_Treatment of vitamin D deficiency: _
800 IU (0.08ml) 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 (0.4ml per day).
Paediatric population
_Prevention_
:
For prevention in children (0 years to 11 years old) with an
identified risk, the recommended
dose is 400 IU (0.04ml) per day.
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For prevention in adolescents (12 years to 18 years old) with an
identified risk, the
recommended dose is 600-800 IU (0.06-0.08ml) per day.
_Treatment of deficiency in children and adolescents_
:
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 (0.1ml) per day for infants
<1 year, 2000 IU
(0.2ml) per day for children 1-10 years and 4000 IU (0.4ml) per day
for adolescents >11
years.
Alternatively, national posology recommendations in prevention and
treatment of vitamin D
deficiency can be followed.
Special Po