One Alpha

国家: 新西兰

语言: 英文

来源: Medsafe (Medicines Safety Authority)

有效成分:

Alfacalcidol 1ug

可用日期:

Link Pharmaceuticals Ltd

INN（国际名称）:

Alfacalcidol 1 µg

剂量:

1 mcg

药物剂型:

Liquid filled capsule

组成:

Active: Alfacalcidol 1ug Excipient: dl-Alpha tocopherol Gelatin Glycerol Iron oxide black Iron oxide red Potassium sorbate Sesame oil

每包单位数:

Blister pack, 10 blister foils of 10 capsules, 100 capsules

类:

Prescription

处方类型:

Prescription

厂商:

Leo Pharma A/S

產品總結:

Package - Contents - Shelf Life: Blister pack, - 100 capsules - 3 years from date of manufacture stored Store below 25°C protect from light

授权日期:

1980-08-21

资料单张

ONE-ALPHA
®
(0.25ΜG AND 1ΜG CAPSULES, 2ΜG/ML DROPS).
CONSUMER MEDICINE INFORMATION
1
ONE-ALPHA
®
ALFACALCIDOL (_AL-FAR-CAL-SEE-DOL) _
_ _
_Capsules: 1 _µg _or 0.25 _µg _alfacalcidol _
_Drops: _2 µg/mL _alfacalcidol _
_ _
CONSUMER MEDICINE INFORMATION (CMI)
_PLEASE READ THIS LEAFLET CAREFULLY _
_BEFORE YOU START YOUR TREATMENT. _
_ _
KEEP THIS LEAFLET. You may want to
read it again.
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about One- Alpha
®
. 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 One-Alpha
®
against the
benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
WHAT ONE-ALPHA
® IS
USED FOR?
ONE-ALPHA
® CAPSULES AND DROPS
both contain a type of vitamin D
called alfacalcidol (al-far-cal-see-
dol). Vitamin D controls the levels of
two substances called calcium and
phosphate in your body. Your body
needs both calcium and phosphate
for healthy bones and teeth.
One-Alpha
®
works by increasing the
amount of vitamin D in your body.
This means the levels of calcium and
phosphate in your body will increase
too.
ONE-ALPHA
®
is used to treat
diseases where the amount
of calcium in your body needs
changing. It is used to treat:
•
Changes in bone caused by
kidney disease.
•
High or low levels of
calcium in the blood due to
changes in small hormone
glands found in the neck. If
the amount of hormone
produced by these glands
is increased or decreased,
it can affect calcium levels
in the blood.
•
Low levels of calcium in the
blood of newborn babies.
•
Softening and/or a change
in shape of the bones due
to lack of calcium.
Your doctor may have prescribed
One-Alpha
®
for another reason.
Ask your doctor or pharmacist if
you have any questions about
why One-Alpha
®
has been
prescribed for you.
BEFORE YOU USE ONE-
ALPHA
®
_WHEN YOU MUST NOT USE _
_ONE-A

产品特点

NEW ZEALAND DATA SHEET
1
ONE-ALPHA
®
One-Alpha
®
0.25 microgram capsules
One-Alpha
®
1.0 microgram capsules
One-Alpha
®
2 micrograms/mL oral drops
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One-Alpha
®
capsules contain either 0.25 microgram or 1.0 microgram of
alfacalcidol.
One-Alpha
®
oral drops contain 2 micrograms/mL of alfacalcidol.
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
One-Alpha
®
0.25 microgram capsules: White oval capsules with a joining seam
around
the middle and 8 mm in length.
One-Alpha
®
1.0 microgram capsules: Smooth, brown oval capsules of 8 mm in length.
One-Alpha
®
2.0 microgram/mL drops is a clear colourless solution.
4
CLINICAL PARTICULARS
4.1
INDICATIONS
Disease caused by disturbances in the calcium metabolism in
consequence of reduced
endogenous production of 1,25-dihydroxyvitamin D
3
.
•
Renal osteodystrophy.
•
Postoperative or idiopathic hypoparathyroidism.
•
Pseudohypoparathyrodism.
•
As an adjunct to the management of tertiary hyperparathyroidism.
•
Vitamin D-resistant rickets or osteomalacia.
•
Vitamin D-dependent rickets, neonatal hypocalcaemia or rickets.
•
Malabsorption of calcium.
•
Malabsorptive and nutritional rickets and osteomalacia.
•
Postmenopausal osteoporosis.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
_ADULTS _
Initial dose: 1 microgram/day
_ELDERLY _
Initial dose: 0.5 microgram/day
_PAEDIATRIC POPULATION _
Initial dose:
Children above 20 kg body weight: 1 microgram/day
Children under 20 kg body weight: 0.05 microgram/kg/day
Neonates: 0.1 microgram/kg/day
It is important to adjust dosage thereafter according to the
biochemical responses and to
avoid hypercalcaemia. Indices of response include levels of serum
calcium, alkaline
phosphatase, parathyroid hormone, urinary calcium excretion as well as
radiographic
and histological investigations. Patients with marked bone disease
(other than those
with renal failure) may tolerate higher doses without developing
hypercalcaemia.
However, failure of the serum calcium to rise promptl