Calcitriol-AFT

Country: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Calcitriol 0.25ug;  

Доступно од:

AFT Pharmaceuticals Ltd

INN (Међународно име):

Calcitriol 0.25 µg

Дозирање:

0.25 mcg

Фармацеутски облик:

Liquid filled capsule

Састав:

Active: Calcitriol 0.25ug   Excipient: Ascorbyl palmitate Butylated hydroxyanisole Gelatin Glycerol Iron oxide red Medium-chain triglycerides Sodium ethyl hydroxybenzoate Sodium propyl hydroxybenzoate Sorbitol Titanium dioxide

Јединице у пакету:

Bottle, glass, Amber, 100 capsules, 100 capsules

Класа:

Prescription

Тип рецептора:

Prescription

Произведен од:

Cerbios-Pharma SA

Терапеутске индикације:

- Established postmenopausal osteoporosis.

Резиме производа:

Package - Contents - Shelf Life: Bottle, glass, Amber, 100 capsules - 100 capsules - 24 months from date of manufacture stored at or below 25°C

Датум одобрења:

2002-09-26

Информативни летак

CALCITRIOL-AFT
CALCITRIOL 0.25ΜG AND 0.5ΜG SOFT GEL CAPSULES
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Calcitriol-AFT soft
gel 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 your
taking Calcitriol-AFT 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 CALCITRIOL-AFT IS USED FOR
Calcitriol occurs naturally in humans and is a biologically active
form of vitamin D.
Calcitriol-AFT is used to treat people with postmenopausal
osteoporosis (bone-
thinning) and to prevent osteoporosis in people taking oral
corticosteroids. Calcitriol-
AFT is also for the treatment of low blood calcium in patients with
renal
osteodystrophy
(a
form
of
bone
disease
due
to
failure
of
the
kidneys),
hypoparathyroidism from various causes (reduced function of the
parathyroid
glands), hyperparathyroidism (excessive levels of the parathyroid
hormone in the
body) and rickets (Vitamin D deficiency).
Calcitriol-AFT works by improving absorption of calcium from the
intestine and by
stimulating growth of healthy bones.
This medicine is available only with a doctor's prescription. Your
doctor may have
prescribed Calcitriol-AFT for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY CALCITRIOL-AFT HAS BEEN
PRESCRIBED FOR YOU.
BEFORE YOU TAKE CALCITRIOL-AFT
_WHEN YOU MUST NOT TAKE IT_
_ _
Do not take Calcitriol-AFT if:
•
you have had an allergic reaction to calcitriol or any other Vitamin
D-like
substances, or any ingredients listed in the Ingredients section of
this leaflet
•
you have high levels of calcium in your blood (called hypercalcaemia)
•
you have high levels of vitamin D in your blood
•
the package is torn or shows signs of tampering
•
the expiry date printed on the pack has pas

Карактеристике производа

Page 1 of 8
NEW ZEALAND DATA SHEET
1.
CALCITRIOL – AFT
Calcitriol – AFT capsules 0.25 μg
Calcitriol – AFT capsules 0.5 μg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcitriol – AFT 0.25 μg: Each capsule contains 0.25μg of
synthetic calcitriol, a biologically
active form of vitamin D3.
Calcitriol – AFT 0.5 μg: Each capsule contains 0.5μg of synthetic
calcitriol, a biologically active
form of vitamin D3.
Excipients with known effect:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, liquid filled.
Calcitriol - AFT are oval, orange soft-gel capsules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
• Established postmenopausal osteoporosis.
•
Renal osteodystrophy in patients with chronic renal failure,
particularly those undergoing
haemodialysis.
• Secondary hyperparathyroidism in patients with moderate to severe
chronic renal failure (pre-
dialysis).
• Postsurgical hypoparathyroidism.
• Idiopathic hypoparathyroidism.
• Pseudohypoparathyroidism.
• Vitamin D-dependent rickets.
• Hypophosphataemic vitamin D-resistant rickets.
• Prevention of corticosteroid induced osteoporosis
4.2
DOSE AND METHOD OF ADMINISTRATION
Standard dosage
The optimal daily dose of Calcitriol-AFT must be carefully determined
for each patient on the basis
of the serum calcium level. Calcitriol-AFT therapy should always be
started at the lowest possible
dose and should not be increased without careful monitoring of serum
calcium (see Patient
monitoring).
Page 2 of 8
A prerequisite for optimal efficacy of Calcitriol-AFT is adequate but
not excessive calcium intake
(in adults: approximately 800mg daily) at the beginning of therapy.
Calcium supplements may be
necessary.
Because of improved calcium absorption from the gastrointestinal
tract, some patients on Calcitriol-
AFT may be maintained on a lower calcium intake. Patients who tend to
develop hypercalcaemia
may require only low doses of calcium or no supplementation at all.
The total daily calcium intake (i.e. from food, and,