ROCALTROL Soft capsules (2014)
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Περιεχόμενα
Name of the medicinal product
Rocaltrol 0.25 microgram Capsules. Rocaltrol 0.5 microgram Capsules.
Qualitative and quantitative composition
Each capsule contains either 0.25 or 0.5 microgram of calcitriol. For excipients, see 6.1.
Pharmaceutical form
Soft capsules. <u>0.25 microgram:</u> One length brown-orange to red-orange opaque and the other white to grey-yellow or grey-orange opaque. <u>0.5 microgram:</u> Both lengths brown-orange to red-orange ...
Therapeutic indications
Rocaltrol is indicated for the correction of the abnormalities of calcium and phosphate metabolism in patients with renal osteodystrophy. Rocaltrol is also indicated for the treatment of established post-menopausal ...
Posology and method of administration
The dose of Rocaltrol should be carefully adjusted for each patient according to the biological response so as to avoid hypercalcaemia. The effectiveness of treatment depends in part on an adequate daily ...
Contraindications
Rocaltrol is contraindicated: in all diseases associated with hypercalcaemia in patients with evidence of metastatic calcification in patients with known hypersensitivity to calcitriol (or drugs of the ...
Special warnings and precautions for use
There is a close correlation between treatment with calcitriol and the development of hypercalcaemia. All other vitamin D compounds and their derivatives, including proprietary compounds or foodstuffs ...
Interaction with other medicinal products and other forms of interaction
Dietary instructions, especially concerning calcium supplements, should be strictly observed, and uncontrolled intake of additional calcium-containing preparations avoided. Concomitant treatment with a ...
Pregnancy and lactation
The safety of Rocaltrol during pregnancy has not been established. Supravalvular aortic stenosis has been produced in foetuses by near-fatal oral doses of vitamin D in pregnant rabbits. There is no evidence ...
Effects on ability to drive and use machines
On the basis of the pharmacodynamic profile of reported adverse events, this product is presumed to be safe or unlikely to adversely affect such activities.
Undesirable effects
The adverse reactions listed below reflect the experience from investigational studies of Rocaltrol, and the post-marketing experience. The most commonly reported adverse reaction was hypercalcaemia. ...
Overdose
Treatment of asymptomatic hypercalcaemia (see section 4.2). Since calcitriol is a derivative of vitamin D, the symptoms of overdose are the same as for an overdose of vitamin D. Intake of high doses of ...
Pharmacodynamic properties
Calcitriol is the most active known form of vitamin D<sub>3</sub> in stimulating intestinal calcium transport. It is normally formed in the kidneys from its immediate precursor, 25-hydroxycholecalciferol. ...
Pharmacokinetic properties
Absorption Calcitriol is rapidly absorbed from the intestine. Peak serum concentrations following a single oral dose of 0.25-1µg Rocaltrol in healthy subjects were found within 2-6 hours. After a single ...
Preclinical safety data
Subchronic toxicity studies in rats and dogs indicated that calcitriol at an oral dose of 20 ng/kg/day (twice the usual human dosage) for up to 6 months produced no or minimal adverse effects. A dose of ...
List of excipients
Content: Butylhydroxyanisole Butylhydroxytoluene Medium-chain triglycerides Shell: Gelatin Glycerol Karion 83 (Sorbitol, Mannitol, Hydrogenated hydrolysed starch) Titanium dioxide E171 Iron oxide red E172 ...
Incompatibilities
None.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C. Store in the original package and keep the blisters in the outer carton in order to protect from light and moisture.
Nature and contents of container
PVC opaque blisters containing 100 capsules (5 strips of 20 capsules).
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom
Marketing authorization number(s)
Rocaltrol 0.25 microgram Capsules: PL 00031/0122 Rocaltrol 0.5 microgram Capsules: PL 00031/0123
Date of first authorization / renewal of the authorization
13 January 2003
Date of revision of the text
24 June 2014
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