ONE-ALPHA CAPSULES 0.5 mcg

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

ALFACALCIDOL

Dostupné z:

ZUELLIG PHARMA PTE. LTD.

ATC kód:

A11CC03

Dávkovanie:

0.5 mcg

Forma lieku:

CAPSULE, LIQUID FILLED

Zloženie:

ALFACALCIDOL 0.5 mcg

Spôsob podávania:

ORAL

Typ predpisu:

Prescription Only

Výrobca:

LEO Pharma A/S

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

1999-07-14

Príbalový leták

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
P
A
RTICULARS
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

Súhrn charakteristických

LEAFLET ONE-ALPHA WKA (LK-SG)
DRAFT (DATE) 07.09.2021 [09:00 uhr] (4)
COLOURS Black linework
DIMENSIONS 170 x 320 mm
MATERIAL NUMBER CP 90006177/10
FONT SIZE 8 pt
MATERIAL NUMBER LEO 070618
PREVIOUS MATERIAL NUMBER LEO 066669
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,
oste