ALPHA D3 1.0 MCG

Země: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktivní složka:

ALFACALCIDOL

Dostupné s:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

ATC kód:

A11CC03

Léková forma:

CAPSULES SOFT GELATIN

Složení:

ALFACALCIDOL 1 MCG

Podání:

PER OS

Druh předpisu:

Required

Výrobce:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Terapeutické oblasti:

ALFACALCIDOL

Terapeutické indikace:

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

Datum autorizace:

2014-10-05

Informace pro uživatele

ALPH CAPS PL SH 220118
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
® 1 MCG
CAPSULES
COMPOSITION
Each soft gelatin capsule contains:
Alfacalcidol 0.25 mcg or 1 mcg
(1α hydroxyvitamin D
3
)
For a list of the inactive ingredients in the preparation,
see section 6 - “Further Information”.
READ THIS 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.
THE MEDICINE CONTAINS A NUMBER OF INGREDIENTS
THAT MAY CAUSE ALLERGY IN PEOPLE SENSITIVE TO
THEM; CAREFULLY READ THE WARNINGS IN SECTION 2.
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.
1. WHAT IS THE MEDICINE INTENDED FOR?
Alpha D
3
is intended to treat renal bone disease
(renal osteodystrophy), rickets and osteomalacia,
hypoparathyroidism,
primary
and
tertiary
hyperparathyroidism (including bone disease) and
osteoporosis.
THERAPEUTIC GROUP:
Vitamin D and analogues.
2. BEFORE USING THE MEDICINE: DO NOT USE THIS MEDICINE IF:
∙ You are sensitive (allergic) to alfacalcidol, to vitamin D
or its derivatives or to any of the other ingredients
contained in the medicine (see section 6 - Further
Information)
∙ You are sensitive (allergic) to peanuts or soya
(the medicine contains small amounts of arachis
oil ]peanut 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 in your body tissues)
BEFORE TREATMENT WITH ALPHA D
3
, TELL YOUR DOCTOR IF:
∙ You suffer from kidney dysfunction, including kidney
stones.
∙ You are on a low-calcium diet (impairs the medicine’s
effectiven

Charakteristika produktu

Alpha D3, MoH 11.2017 SZ - LK
The format of this leaflet was determined by the Ministry of health
and its content was
checked and approved on November 2017
ALPHA D
3
®
Capsules
COMPOSITION
_ALPHA D3 CAPSULES 0.25 MCG _
Each soft gelatin capsule contains:
_CAPSULE CONTENT _
_Active Ingredient _
Alfacalcidol (1

-OHD
3
) 0.25 mcg
_Other Ingredients _
Arachis oil (peanut oil), dehydrated alcohol, Propyl gallate,
dl-alpha-tocopherol,
citric acid anhydrous.
_SOFT GELATIN CAPSULE SHELL _
Gelatin,
glycerol,
Anidrisorb
85/70
(sorbitol,
mannitol,
sorbitan,
hydrogenation
products of partly hydrolyzed starch, water), red iron oxide (E 172),
priting ink black,
water.
_ALPHA D3 CAPSULES 0.5 MCG _
Each soft gelatin capsule contains:
_CAPSULE CONTENT _
_Active Ingredient _
Alfacalcidol (1

-OHD
3
) 0.5 mcg
_Other Ingredients _
Arachis oil (peanut oil), dehydrated alcohol, Propyl gallate,
dl-alpha-tocopherol,
citric acid anhydrous.
_SOFT GELATIN CAPSULE SHELL _
Gelatin,
glycerol,
Anidrisorb
85/70
(sorbitol,
mannitol,
sorbitan,
hydrogenation
products of partly hydrolyzed starch, water), titanium dioxide (E171),
red iron oxide
(E172), printing ink black, water.
_ALPHA D3 CAPSULES 1 MCG _
Each soft gelatin capsule contains:
_CAPSULE CONTENT _
_Active Ingredient _
Alfacalcidol (1

-OHD
3
) 1 mcg
_ _
_Other Ingredients _
Arachis oil (peanut oil), dehydrated alcohol, Propyl gallate,
dl-alpha-tocopherol,
citric acid anhydrous.
_ _
2
Alpha D3, MoH 11.2017 SZ - LK
_SOFT GELATIN CAPSULE SHELL _
Gelatin,
glycerol,
Anidrisorb
85/70
sorbitol,
mannitol,
sorbitan,
hydrogenation
products of partly hydrolyzed starch, water), titanium dioxide (E171),
yellow iron
oxide (E172), priting ink black, water.
THERAPEUTIC INDICATIONS
Alpha D
3
is used for treating:

Renal bone disease (renal osteodystrophy)

Hypoparathyroidism

Hyperparathyroidism (with bone disease)- primary and tertiary.

Rickets and osteomalacia.

Osteoporosis
DOSAGE AND ADMINISTRATION
_General _
_ _The dosage and administration of Alpha D
3
should be adjusted