ZURAMPIC Film-coated tablet (2017)
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Περιεχόμενα
Name of the medicinal product
Zurampic 200 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 200 mg of lesinurad. Excipient with known effect: Each tablet contains 52.92 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet (tablet). Oval, 5.7 12.9 mm, blue tablets. Tablets are engraved with LES200 on one side.
Therapeutic indications
Zurampic, in combination with a xanthine oxidase inhibitor, is indicated in adults for the adjunctive treatment of hyperuricaemia in gout patients (with or without tophi) who have not achieved target serum ...
Posology and method of administration
Posology The recommended dose of Zurampic is 200 mg once daily in the morning. This is also the maximum dose (see section 4.4). Zurampic tablets must be co-administered at the same time as the morning ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with tumour lysis syndrome or Lesch-Nyhan syndrome. Severe renal impairment (CrCL less than 30 mL/min), ...
Special warnings and precautions for use
Renal events Treatment with lesinurad 200 mg in combination with a xanthine oxidase inhibitor was associated with an increased incidence of serum creatinine elevations, which are related to increased renal ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions Salicylates Salicylates at doses higher than 325 mg per day may decrease the serum uric acid lowering activity of lesinurad and should not be co-administered with Zurampic. ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of lesinurad in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a ...
Effects on ability to drive and use machines
Lesinurad has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The safety of Zurampic 200 mg was evaluated in the Phase 3 combination therapy clinical trials (including extension studies). The most commonly reported adverse reactions ...
Overdose
There is no specific treatment in the event of an overdose, and symptoms of overdose are not established. In case of overdose, patients should be managed by symptomatic and supportive care including adequate ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antigout preparations, preparations increasing uric acid excretion ATC code: M04AB05 Mechanism of action Lesinurad is a selective uric acid reabsorption inhibitor that inhibits ...
Pharmacokinetic properties
Absorption The absolute bioavailability of lesinurad is approximately 100%. Lesinurad is rapidly absorbed after oral administration. Following administration of a single oral dose of lesinurad in either ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. ...
List of excipients
Tablet core: Hypromellose Microcrystalline cellulose Lactose monohydrate Crospovidone type A Magnesium stearate Tablet coat: Hypromellose Titanium dioxide Triacetin Indigo Carmine Brilliant Blue FCF
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Clear (PVC/PVDC/Aluminium) blister of 10 or 14 (calendar blister) tablets. Pack sizes of 10, 28, 30, 98 in non-perforated blisters. Pack size of 100 1 film-coated tablet in perforated unit dose blisters. ...
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Grünenthal GmbH, Zieglerstr. 6, 52078, Aachen, Germany, Tel.: +49-241-569-0
Marketing authorization number(s)
EU/1/15/1080/001 10 film-coated tablets EU/1/15/1080/002 28 film-coated tablets EU/1/15/1080/003 30 film-coated tablets EU/1/15/1080/004 98 film-coated tablets EU/1/15/1080/005 100x1 film-coated tablets ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 18 February 2016
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