ALPHA D3 0.25 MCG

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

ALFACALCIDOL

Disponible depuis:

TRUEMED LTD, ISRAEL

Code ATC:

A11CC03

forme pharmaceutique:

CAPSULES SOFT GELATIN

Composition:

ALFACALCIDOL 0.25 MCG

Mode d'administration:

PER OS

Type d'ordonnance:

Required

Fabriqué par:

THERAMEX IRELAND LIMITED, IRELAND

Groupe thérapeutique:

ALFACALCIDOL

Domaine thérapeutique:

ALFACALCIDOL

indications thérapeutiques:

- Renal bone disease (renal osteodystrophy). - Hypoparathyroidism. - Hyperparathyroidism (with bone disease) - primary and tertiary. - Rickets and osteomalacia. - Osteoporosis.

Date de l'autorisation:

2022-05-31

Notice patient

PL-1044 02-01.22
PL-1044 02-01.22
IPS THX 2866
IPS THX 2866
PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE
PHARMACISTS’REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed with a
doctor’s prescription only
ALPHA D
3 0.25 MCG
ALPHA D
3 0.5 MCG
ALPHA D
3 1.0 MCG
CAPSULES
ACTIVE INGREDIENT
Each soft gelatin capsule contains:
Alfacalcidol 0.25 mcg, 0.5 mcg or 1 mcg
(1α hydroxyvitamin D
3
)
For the inactive and allergenic ingredients
in the medicine, see section 2 under
“Important information about some of the
ingredients of the medicine” and section
6 “Further Information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY
BEFORE USING THE MEDICINE. This leaflet
contains concise information about the
medicine. If you have further questions,
refer to the doctor or pharmacist.
This medicine has been prescribed for
the treatment of your ailment. Do not pass
it on to others. It may harm them, even if it
seems to you that their ailment is similar.
THE MEDICINE CONTAINS A NUMBER OF
INGREDIENTS THAT MAY CAUSE ALLERGY
IN PEOPLE SENSITIVE TO THEM; CAREFULLY
READ THE WARNINGS IN SECTION 2.
1. WHAT
IS
THE
MEDICINE
INTENDED FOR?
Alpha D
3
is intended to treat bone disease
related to kidney problems (renal bone
disease [renal osteodystrophy](, rickets
an
d osteomalacia,
hypoparathyroidism,
primary and tertiary hyperparathyroidism
)including bone disease) and osteoporosis.
THERAPEUTIC GROUP: Vitamin D and
analogs.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• You are sensitive (allergic( to
alfacalcidol, to vitamin D or its
derivatives or to any of the additional
ingredients contained in the medicine
)see section 6 “Further Information”).
• You are sensitive (allergic( to
peanuts or soya. The medicine
contains a small amount of peanut oil
(arachis oil(, which can cause a severe
allergic reaction in people sensitive to
these ingredients.
• You suffer from high levels of calcium
in the blood (hypercalcemia(.
• You suffer from calcification (a
condition in which you have high levels
of calcium i

Résumé des caractéristiques du produit

P a g e |
1
1 NAME OF THE MEDICINAL PRODUCT
ALPHA D
3 0.25 MCG
ALPHA D
3 0.5 MCG
ALPHA D
3 1.0 MCG
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_ALPHA D3 0.25 MCG _
Soft gelatin capsules containing alfacalcidol (1 α-hydroxyvitamin D
3
) 0.25
microgram.
_ALPHA D3 0.5 MCG _
Soft gelatin capsules containing alfacalcidol (1 α-hydroxyvitamin D
3
) 0.5
microgram.
_ALPHA D3 1 MCG _
Soft gelatin capsules containing alfacalcidol (1 α-hydroxyvitamin D
3
) 1
microgram.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft.
_ALPHA D_
_3_
_ 0.25 MCG_
Oval, opaque reddish-brown, elastic soft gelatin capsule, imprinted
“0.25” on
one side with black ink, containing clear, pale yellow oily solution.
_ALPHA D_
_3_
_ 0.5 MCG _
Oval, opaque pale pink, elastic soft gelatin capsule, imprinted
“0.5” on one
side with black ink, containing clear, pale, yellow oily solution.
_ALPHA D_
_3 _
_1 MCG _
Oval, opaque cream to ivory, elastic soft gelatin capsule, imprinted
“1.0” on
one side with black ink, containing clear, pale, yellow oily solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Renal bone disease (renal osteodystrophy)

Hypoparathyroidism

Hyperparathyroidism (with bone disease)- primary and tertiary.

Rickets and osteomalacia.

Osteoporosis
Page | 2
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_General _
The dosage and administration of Alpha D
3
should be adjusted according to
the indication-specific notes which follow.
The initial dosage for all indications, excepting osteoporosis, is as
follows:
Adults and children 20 kg and over bodyweight:
1 mcg/day
Elderly patients:
0.5 mcg/day
The recommended dosage in osteoporosis is 0.5 mcg/day. It should not
be
exceeded.
The dose should subsequently be adjusted to avoid hypercalcaemia,
according to the biochemical response. Plasma calcium levels
(preferably
corrected for protein binding) should initially be measured weekly.
The dose
of Alpha D
3
can be increased by increments of 0.25 to 0.5 mcg/day. Most
adults respond to doses of 1 to 3 mcg/day