ROCALTROL calcitriol 0.25 microgram capsule blister pack

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

calcitriol, Quantity: 0.25 microgram

Commercializzato da:

Atnahs Pharma Australia Pty Ltd

Forma farmaceutica:

Capsule, soft

Composizione:

Excipient Ingredients: Gelatin; butylated hydroxyanisole; glycerol; iron oxide red; iron oxide yellow; titanium dioxide; medium chain triglycerides; butylated hydroxytoluene; maize starch; sorbitol; mannitol

Via di somministrazione:

Oral

Confezione:

100 capsules

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

For the management of established post-menopausal osteoporosis by increasing calcium absorption, elevating circulating levels of calcitriol, and reducing vertebral fracture frequency. For the prevention of corticosteriod-induced osteoporosis in patients commencing oral steroid therapy in a dose and regimen expected to result in a significant bone loss. For the treatment of hypoclacamia in patients with uraemic osteodystrophy, hypoparathyroidism and Vitamin D resistant rickets. INDICATIONS AS AT 4 MARCH 2004: Rocaltrol is indicated for the treatment of established osteoporosis diagnosed by objective measuring techniques, such as densitometry, or by radiographic evidence of a traumatic fracture. Rocaltrol is also indicated for the prevention of corticosteriod-induced osteoporosis in patients commencing oral steroid therapy in a dose and regimen expected to result in a significant bone loss. Rocaltrol is indicated in the treatment of hypocalcemia in patients with uremic osteodystrophy, hypoparathyroidism and in hypophosphatemic rickets.

Dettagli prodotto:

Visual Identification: OVAL SOFT GELATIN CAPSULES, ONE HALF BROWN-ORANGE TO RED-ORANGE, OPAQUE, ONE HALF WHITE TO GREY-YELLOW OR ORANGE-GREY, OPAQUE.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2003-03-18

Foglio illustrativo

ROCALTROL
®
_contains the active ingredient calcitriol_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Rocaltrol capsules.
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 Rocaltrol
capsules 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 ROCALTROL IS USED
FOR
Rocaltrol is used to treat people with
osteoporosis and to prevent
osteoporosis in people taking oral
corticosteroids.
Rocaltrol capsules are 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.
Rocaltrol works by improving
absorption of calcium from the
intestine and by stimulating growth
of healthy bones.
Rocaltrol contains calcitriol which
occurs naturally in humans and is a
biologically active form of vitamin
D.
There are many different types of
medicines used to treat bone
conditions. Rocaltrol belongs to a
group of medicines known as vitamin
D compounds.
Your doctor, may have prescribed
Rocaltrol for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY ROCALTROL HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
Rocaltrol is not addictive.
BEFORE YOU TAKE
ROCALTROL
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ROCALTROL IF:
1.
YOU HAVE HAD AN ALLERGIC
REACTION TO ROCALTROL, CALCITRIOL,
OTHER VITAMIN D COMPOUNDS, OR
ANY INGREDIENTS LISTED AT THE END
OF THIS LEAFLET
2.
YOU HAVE HIGH LEVELS OF CALCIUM
IN YOUR BLOOD (CALLED
HYPERCALCAEMIA)
3.
YOU HAVE VITAMIN D TOXICITY
4.
YOU ARE BREAST-FEEDING OR
INTEND TO BREAST-FEED
Rocaltrol may pass into breast
milk and have unwanted effects
in the baby.
DO

Scheda tecnica

1
AUSTRALIAN PRODUCT INFORMATION
ROCALTROL (CALCITRIOL)
1.
NAME OF THE MEDICINE
Calcitriol
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rocaltrol 0.25 microgram capsules containing 0.25micrograms of
calcitriol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Soft capsules
Capsules are opaque, coloured half brown-orange to red-orange and half
white to grey-
yellow/grey-orange.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rocaltrol is indicated for the treatment of established osteoporosis
diagnosed by objective
measuring techniques, such as densitometry, or by radiographic
evidence of a traumatic
fracture.
Rocaltrol is also indicated for the prevention of
corticosteroid-induced osteoporosis in
patients commencing oral steroid therapy in a dose and regimen
expected to result in a
significant bone loss.
Rocaltrol is indicated in the treatment of hypocalcaemia in patients
with uraemic
osteodystrophy, hypoparathyroidism and in hypophosphataemic rickets.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
The optimal daily dose of Rocaltrol 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 Rocaltrol 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 Rocaltrol 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, Rocaltrol should be suspended immediately
and serum calcium
and phosphate levels must be determined d