FOSRENOL Chewable tablet (2022)
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Περιεχόμενα
Name of the medicinal product
Fosrenol 500 mg chewable tablets. Fosrenol 750 mg chewable tablets. Fosrenol 1000 mg chewable tablets.
Qualitative and quantitative composition
<u>Fosrenol 500 mg chewable tablets:</u> Each chewable tablet contains lanthanum carbonate hydrate corresponding to 500 mg lanthanum. <u>Fosrenol 750 mg chewable tablets:</u> Each chewable tablet contains ...
Pharmaceutical form
Chewable tablet. Fosrenol 500 mg chewable tablets: White, round, 18mm, bevelled-edge flat tablets debossed with S405/500 on one side. Fosrenol 750 mg chewable tablets: White, round, 20mm, bevelled-edge ...
Therapeutic indications
Fosrenol is indicated in adult patients as a phosphate binding agent for use in the control of hyperphosphataemia in chronic renal failure patients on haemodialysis or continuous ambulatory peritoneal ...
Posology and method of administration
Fosrenol is for oral administration. The tablets must be chewed completely and not swallowed whole. To aid with chewing the tablets may be crushed. Fosrenol oral powder can be used in patients who have ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 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 machinery.
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 4718mg 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. Lanthanum 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
White cylindrical HDPE bottles containing a rayon coil fitted with a tamper evident, child resistant polypropylene screw cap. <u>Pack sizes:</u> Fosrenol 500 mg chewable tablets: 20, 45 tablets. Multipack ...
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)
Fosrenol 500 mg chewable tablets: PL 16189/0139 Fosrenol 750 mg chewable tablets: PL 16189/0140 Fosrenol 1000 mg chewable tablets: PL 16189/0138
Date of first authorization / renewal of the authorization
Date of first authorisation: 12 September 2006 Date of latest renewal: 19 March 2014
Date of revision of the text
02 November 2022
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