ZODORAY Capsule (2021)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
ZODORAY 0,25 µg capsules. ZODORAY 0,5 µg capsules. ZODORAY 1 µg capsules.
2. Qualitative and quantitative composition
ZODORAY 0,25 µg capsules: Each capsule contains 0,25 µg alfacalcidol. ZODORAY 0,5 µg capsules: Each capsule contains 0,50 µg alfacalcidol. ZODORAY 1 µg capsules: Each capsule contains 1 µg alfacalcidol. ...
3. Pharmaceutical form
<u>ZODORAY 0,25 µg capsules:</u> Reddish brown coloured, oval shaped soft gelatine capsules containing clear oily liquid. <u>ZODORAY 0,5 µg capsules:</u> Light pink coloured, oval shaped soft gelatine ...
4.1. Therapeutic indications
a) Renal osteodystrophy b) Hypoparathyroidism c) Hyperparathyroidism (with bone disease) d) Hypophosphataemic vitamin D resistant rickets and osteomalacia e) Pseudo-deficiency (vitamin D-dependent) rickets ...
4.2. Posology and method of administration
Posology Initial dose for all indications <u>Adults:</u> 1 µg daily <u>Children 20 kg body weight and above:</u> 1 µg daily <u>Children less than 20 kg body weight:</u> 0,05 µg/kg daily <u>Elderly:</u> ...
4.3. Contraindications
Hypersensitivity to alfacalcidol or to any of the excipients (see section 6.1). Hypercalcaemia or evidence of vitamin D intoxication. Pregnancy and lactation.
4.4. Special warnings and precautions for use
1α-OHD<sub>3</sub> should be given with care to patients with impaired renal function. If hypercalcaemia is induced by 1α-OHD<sub>3</sub> it can be rapidly corrected by stopping treatment Throughout treatment, ...
4.5. Interaction with other medicinal products and other forms of interaction
<u>Thiazide diuretics and calcium containing preparations:</u> Concurrent use of thiazide diuretics or calcium containing preparations may enhance the risk of hypercalcaemia. Calcium levels should be monitored. ...
4.6. Fertility, pregnancy and lactation
Pregnancy ZODORAY should not be used in pregnancy. ZODORAY should not be used in the first trimester of pregnancy. Hypercalcaemia may produce congenital disorders. There are no adequate data from the use ...
4.7. Effects on ability to drive and use machines
ZODORAY has no or negligible influence on the ability to drive or use machines.
4.8. Undesirable effects
a. Summary of the safety profile The most frequently reported undesirable effects are hypercalcaemia and various skin reactions such as pruritus and rash, gastrointestinal pain/discomfort and hyperphosphataemia. ...
4.9. Overdose
The initial signs and symptoms of vitamin D intoxication associated with hypercalcaemia include weakness, fatigue, somnolence, headache, anorexia, nausea, vomiting, diarrhoea, and pruritus. If hypercalcaemia ...
5.1. Pharmacodynamic properties
<b>Pharmacological classification:</b> A 22.1.4 Vitamins: Other Pharmacotherapeutic group: Vitamin D and analogues <b>ATC code:</b> A11CC03 1α-hydroxyvitamin D<sub>3</sub> (1α-OHD<sub>3</sub>) is converted ...
5.2. Pharmacokinetic properties
In patients with renal failure, 1-5 microgram/day of 1α-hydroxyvitamin D (1α-OHD<sub>3</sub>) increased intestinal calcium and phosphorus absorption in a dose related manner. This effect was observed within ...
6.1. List of excipients
Anhydrous citric acid All-rac-alpha-tocopherol (antioxidant) Propyl gallate (antioxidant) Anhydrous ethanol (1,0 % v/v) Refined arachis oil (peanut oil) <u>Soft gelatine capsule shell:</u> Gelatine, glycerol ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years. Store at or below 25°C.
6.4. Special precautions for storage
This medicine does not require any special storage conditions.
6.5. Nature and contents of container
White, opaque HDPE container with white opaque HDPE screw closure and induction sealing. Pack sizes of 30s, 50s and 100s. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Strides Pharma SA (Pty) Ltd., 106 16th Road, Building 2, Midrand, 1685
10. Date of revision of the text
09 March 2021
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
