APO-CALCITRIOL calcitriol 0.25 microgram capsule blister pack

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

calcitriol

متاح من:

Apotex Pty Ltd

INN (الاسم الدولي):

Calcitriol

الوضع إذن:

Registered

نشرة المعلومات

APO-CALCITRIOL
CAPSULES
_Contains the active ingredient calcitriol_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Calcitriol. It contains the active
ingredient, calcitriol.
It is used to treat people with
osteoporosis and to prevent
osteoporosis in people taking oral
corticosteroids.
It is also prescribed by doctors for
the treatment of low blood calcium in
patients with osteodystrophy (a form
of bone disease), hypoparathyroidism
(reduced function of the parathyroid
glands) and rickets.
_HOW IT WORKS_
It works by improving absorption of
calcium from the intestine and by
stimulating growth of healthy bones.
Calcitriol occurs naturally in humans
and is a biologically active form of
vitamin D.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
calcitriol or any other medicine
containing vitamin D compounds
•
any of the ingredients listed at the
end of this leaflet
Symptoms of an allergic reaction
may include:
•
cough, shortness of breath,
wheezing or difficulty breathing
•
swelling of the face, lips, tongue,
throat or other parts of the body
•
rash, itching or hives on the ski

خصائص المنتج

1
AUSTRALIAN PRODUCT INFORMATION
APO-CALCITRIOL (CALCITRIOL) CAPSULES
1
NAME OF THE MEDICINE
Calcitriol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each APO-Calcitriol capsule contains 0.25 μg of calcitriol as active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Gelatin
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Red coloured, oval soft gelatin capsules containing a clear oily
liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
APO-Calcitriol is indicated for the:
•
treatment
of
established
osteoporosis
diagnosed
by
objective
measuring
techniques, such as densitometry, or by radiographic evidence of a
traumatic
fracture
•
prevention of corticosteroid-induced osteoporosis in patients
commencing oral
steroid therapy in a dose and regimen expected to result in a
significant bone loss
•
treatment
of
hypocalcaemia
in
patients
with
uraemic
osteodystrophy,
hypoparathyroidism and in hypophosphataemic rickets.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Calcitriol capsules are intended for oral administration.
DOSAGE
GENERAL
The optimal daily dose of calcitriol must be carefully determined for
each patient and indication.
Dosage
optimisation
should
be
accompanied
by
regular
monitoring
of
serum
calcium
concentration.
When the optimal dosage of calcitriol has been determined, the serum
calcium levels should
be checked regularly. As soon as serum calcium nears hypercalcaemic
levels (1 mg per
100 mL [0.25 mmol/L] above normal 9-11 mg per 100 mL [2.25-2.75
mmol/L] on average), the
dosage of calcitriol should be substantially reduced or treatment
stopped altogether until
normocalcaemia
ensues.
If
hypercalcaemia
occurs,
the
drug
should
be
immediately
discontinued until normocalcaemia ensues. Withdrawal of additional
doses of calcium can also
be
of
benefit
in
bringing
about
rapid
normalisation
of
serum
calcium
levels.
Careful
consideration should also be given to lowering the dietary calcium
intake.
Should hypercalcaemia occur, calcitriol should be suspended
immediately and se