FOSRENOL Oral powder (2022)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Fosrenol 750 mg oral powder.
Qualitative and quantitative composition
Each sachet contains 750 mg lanthanum (as lanthanum carbonate hydrate). <u>Excipient(s) with known effect:</u> Each sachet also contains 641.7 mg dextrates, containing glucose. For the full list of excipients, ...
Pharmaceutical form
Oral Powder. White to off-white powder.
Therapeutic indications
Fosrenol is indicated as a phosphate binding agent for use in the control of hyperphosphataemia in chronic renal failure patients on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Fosrenol ...
Posology and method of administration
Fosrenol is for oral administration. Fosrenol oral powder is intended to be mixed with a small quantity of soft food (e.g. applesauce or other similar food product) and consumed immediately (within 15 ...
Contraindications
Hypersensitivity to lanthanum carbonate hydrate or to any of the excipients. Hypophosphataemia.
Special warnings and precautions for use
Tissue deposition of lanthanum has been shown with Fosrenol in animal studies. In 105 bone biopsies from patients treated with Fosrenol, some for up to 4.5 years, rising levels of lanthanum were noted ...
Interaction with other medicinal products and other forms of interaction
Lanthanum carbonate hydrate may increase gastric pH. It is recommended that compounds, which are known to interact with antacids, should not be taken within 2 hours of dosing with Fosrenol (e.g. chloroquine, ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of Fosrenol in pregnant women. One study in rats showed reproductive foetotoxicity (delayed eye opening and sexual maturation) and reduced pup weights ...
Effects on ability to drive and use machines
Fosrenol may induce dizziness and vertigo, which may impair the ability to drive and use machines.
Undesirable effects
The most commonly reported adverse drug reactions, with the exception of headache and allergic skin reactions, are gastrointestinal in nature; these are minimised by taking Fosrenol with food and generally ...
Overdose
No case of overdose has been reported. The highest daily dose of lanthanum administered to healthy volunteers during Phase I studies was 4718 mg given for 3 days. The adverse events seen were mild to moderate ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs for treatment of hyperkalaemia and hyperphosphataemia. <b>ATC code:</b> V03AE03 Fosrenol contains lanthanum carbonate hydrate. The activity of lanthanum carbonate ...
Pharmacokinetic properties
As binding between lanthanum and dietary phosphorus occurs in the lumen of the stomach and upper small intestine, the therapeutic effectiveness of Fosrenol is not dependent on levels of lanthanum in the ...
Preclinical safety data
Preclinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeated dose toxicity, fertility or genotoxicity. L anthanum carbonate hydrate reduced gastric ...
List of excipients
Dextrates (hydrated) Colloidal anhydrous silica Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
2.1 g of oral powder in sachets formed from a polyethylene terephthalate/aluminium/polyethylene laminate. <u>Pack size:</u> 90 sachets (Outer carton contains 9 cartons of 10 sachets).
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Takeda UK Ltd, 1 Kingdom Street, London, W2 6BD, United Kingdom
Marketing authorization number(s)
PL 16189/0141
Date of first authorization / renewal of the authorization
Date of first authorisation: 13/04/2012 Date of latest renewal: 19/03/2012
Date of revision of the text
02 November 2022
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