Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
ALFACALCIDOL
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
CAPSULES SOFT GELATIN
ALFACALCIDOL 0.5 MCG
PER OS
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
- Renal bone disease (renal osteodystrophy). - Hypoparathyroidism. - Hyperparathyroidism (with bone disease) - primary and tertiary. - Rickets and osteomalacia. - Osteoporosis.
2016-10-31
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 Pročitajte cijeli dokument
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 Pročitajte cijeli dokument