ONE-ALPHA INJECTION 2 mcgml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ALFACALCIDOL

Available from:

ZUELLIG PHARMA PTE. LTD.

ATC code:

A11CC03

Dosage:

2 mcg/ml

Pharmaceutical form:

INJECTION

Composition:

ALFACALCIDOL 2 mcg/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

CENEXI

Authorization status:

ACTIVE

Authorization date:

1991-06-20

Patient Information leaflet

008828-07

008828-07
VITAMIN D ANALOGUE
ONE-ALPHA
®
CAPSULES
Alfacalcidol 0.25 µg, 0.5 µg or 1 µg
Pack size: 100
DROPS
Alfacalcidol 2 µg/ml (one drop provides 0.1 µg)
SOLUTION
Alfacalcidol 0.2 µg/ml
INJECTION
Alfacalcidol 2 µg/ml (for i.v. use)
PROPERTIES
Alfacalcidol (1
α
-hydroxyvitamin D
3
) is rapidly converted in the
liver to 1.25-dihydroxyvitamin D
3
, the metabolite of vitamin D
which acts as a regulator of calcium and phosphate homeostasis.
Impaired endogenous production of 1.25-dihydroxyvitamin D
3
by the kidneys contributes to the disturbances in mineral
metabolism found in several disorders, including renal bone
disease, hypoparathyroidism, and vitamin D-dependent rickets.
These disorders require high doses of vitamin D for their correction
but only small doses of One-Alpha
®
. As compared with Vitamin D,
the main advantage of One-Alpha
®
is the more rapid onset and
reversal of action which allows a more accurate dose titration and
decreases the risk of prolonged hypercalcaemia.
INDICATIONS
Diseases caused by disturbances in the calcium metabolism in
consequence of reduced endogenous production of 1.25-
dihydroxyvitamin D
3
.
Renal osteodystrophy, postoperative or idiopathic hypo-
parathyroidism, pseudohypoparathyroidism, 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,
osteoporosis, malabsorptive and nutritional rickets, and
osteomalacia.
DOSAGE
Initial dose:
Adults and children above 20 kg body weight: 1 µg daily.
Children under 20 kg body weight: 0.05 µg/kg/day.
Neonates: 0.1 µg/kg/day.
It is important to adjust the dosage according to the biochemical
responses 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 r

Summary of Product characteristics

ONE‐ALPHA®
1.
NAME OF MEDICINAL PRODUCT
One‐Alpha
®
Alfacalcidol
Carefully read this insert before administering this product. It
contains information about your treatment.
If you have any doubt or you are not sure about something, please ask
your physician or Pharmacist chemist.
Keep this insert as you might need to read it again.
Verify this product fully corresponds to the one prescribed by your
physician.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CAPSULES
Alfacalcidol 0.25 microgram, 0.5 microgram and 1 microgram
Pack sizes: 10, 30, 50 and 100 capsules
Excipients the clinician should be aware of: Sesame oil
DROPS
Alfacalcidol 2 micrograms/ml (one drop provides 0.1 microgram)
Excipients
the
clinician
should
be
aware
of:
Ethanol,
sorbitol,
methyl
parahydroxybenzoate,
macrogolglycerol hydroxystearate
Pack sizes: 10 ml and 20 ml
SOLUTION FOR INJECTION
Alfacalcidol 2 micrograms/ml (for i.v. use)
Pack sizes: 0.5 ml x 10 ampules and 1 ml x 10 ampules
List of excipients, see section 6.1
Not all pack sizes, strengths and formulations may be marketed
3.
PHARMACEUTICAL FORM
CAPSULES
Soft capsules; cream‐coloured (0.25 microgram), pink (0.5
microgram), or brownish (1 microgram)
DROPS
Oral drops; slightly cloudy to clear, colourless
SOLUTION FOR INJECTION
Solution for injection (for i.v. use); clear and colourless
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Diseases caused by disturbances in the calcium metabolism in
consequence of reduced endogenous
production
of
1.25‐dihydroxyvitamin
D
3
.
Renal
osteodystrophy,
postoperative
or
idiopathic
hypo‐
parathyroidism,
pseudohypoparathyroidism,
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, osteoporosis,
malabsorptive and nutritional rickets,
and osteomalacia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Individual dosage under thorough control of serum calcium.
Adults and children over 20 kg: Initially 1