CALITROL calcitriol 0.25 microgram capsule blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

calcitriol, Quantity: 0.25 microgram

Dostopno od:

Arrotex Pharmaceuticals Pty Ltd

INN (mednarodno ime):

Calcitriol

Farmacevtska oblika:

Capsule, soft

Sestava:

Excipient Ingredients: fractionated coconut oil; butylated hydroxyanisole; butylated hydroxytoluene; Gelatin; glycerol; sorbitol solution (70 per cent) (non-crystallising); purified water; iron oxide red; iron oxide yellow; titanium dioxide

Pot uporabe:

Oral

Enote v paketu:

100 capsules

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

Calcitriol is indicated for the treatment of established osteoporosis diagnosed by objective measuring techniques, such as densitometry, or by radiographic evidence of atraumatic fracture.,Calcitriol 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.,Calcitriol is indicated in the treatment of hypocalcemia in patients with uremic osteodystrophy, hypoparathyroidism and in hypophosphataemic rickets.

Povzetek izdelek:

Visual Identification: Red coloured, oval soft gelatin capsules containing a clear oily liquid.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Status dovoljenje:

Licence status A

Datum dovoljenje:

2015-12-01

Navodilo za uporabo

_ _
_CALITROL capsules – Consumer Medicine Information _
_ _
_CALITROL CMI _
_ _
_ _
_Page 1 _
CALITROL CAPSULES
_Calcitriol _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
CALITROL 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
CALITROL 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 CALITROL IS
USED FOR
CALITROL contains
the
active
ingredient calcitriol,
one
of
the
naturally
occurring
and
biologically
active
forms
of
Vitamin D. Calcitriol acts in the
body
in
a
similar
manner
to
Vitamin D.
CALITROL is used to treat people
with
osteoporosis,
a
disease
where
the
bones
of
the
body
weaken, and in the prevention of
osteoporosis
in people
taking
oral corticosteroids.
CALITROL
capsules
are
also
prescribed for patients who have
low blood calcium levels due to
osteodystrophy (a type of bone
disease),
hypoparathyroidism (a
condition where the parathyroid
glands have decreased function)
and rickets.
CALITROL
increases
calcium
absorption
in
the intestine and
stimulates healthy bone growth.
There are many different types
of medicines used to treat bone
conditions.
CALITROL belongs
to a group of medicines known as
vitamin D compounds.
Your doctor may have prescribed
CALITROL for another purpose.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS WHY CALITROL
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only
with a doctor's prescription.
CALITROL is not addictive.
BEFORE YOU TAKE
CALITROL
_ _
_WHEN YOU MUST NOT TAKE _
_IT _
_ _
DO NOT TAKE CALITROL IF:
•
YOU
HAVE
HAD
AN
ALLERGIC
REACTION
TO
CALITROL,
CALCITRIOL
OR
ANY
INGREDIENTS
LISTED
IN
THE
INGREDIENTS
SECTION OF THIS LEAFLET
•
YOU
HAVE
HIGH
BLOOD
CALCIUM
LEVELS
(HYPERCALCAE

Lastnosti izdelka

1
AUSTRALIAN PRODUCT INFORMATION –
CALITROL (
CALCITRIOL 0.25 MICROGRAM
) CAPSULES
1
NAME OF THE MEDICINE
The name of the medicine is Calcitriol.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcitriol is available as soft gelatin capsules containing 0.25
micrograms of calcitriol.
Calcitriol is a white, crystalline compound, which occurs naturally in
humans. It is soluble in organic
solvents but practically insoluble in water.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
CALITROL 0.25 microgram is supplied as soft red coloured, oval soft
gelatine capsule containing a
clear oily liquid.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
CALITROL is indicated for the treatment of established osteoporosis
diagnosed by objective
measuring techniques, such as densitometry, or by radiographic
evidence of atraumatic fracture.
CALITROL 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.
CALITROL is indicated in the treatment of hypocalcemia in patients
with uremic osteodystrophy,
hypoparathyroidism and in hypophosphataemic rickets.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The optimal daily dose of CALITROL must be carefully determined for
each patient and
indication. Dosage optimisation should be accompanied by regular
monitoring of serum calcium
concentration. If hypercalcemia occurs, the drug should be immediately
discontinued until
normocalcemia ensues.
ADULTS: OSTEOPOROSIS:
_ESTABLISHED OSTEOPOROSIS: _The recommended dose of CALITROL is 0.25
microgram twice daily. If a
satisfactory response is not obtained with this dose, it may be
increased, with regular serum
calcium monitoring, to a maximum of 0.5 microgram twice daily. This
increased dose should rarely
be necessary.
2
_CORTICOSTEROID-INDUCED OSTEOPOROSIS: _The recommended dose is 0.25
microgram twice daily for
steroid doses equivalent to < 10 mg/day of oral prednisone increasing
to 0.