MEZAVANT XL Gastro-resistant, prolonged release tablets (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Mezavant XL 1200mg, gastro-resistant, prolonged release tablets.
Qualitative and quantitative composition
Each tablet contains 1200mg mesalazine. For a full list of excipients, see section 6.1.
Pharmaceutical form
Gastro-resistant, prolonged release tablets. Red-brown, ellipsoidal, film-coated tablet, debossed on one side with S476.
Therapeutic indications
For the induction of clinical and endoscopic remission in patients with mild to moderate, active ulcerative colitis. For maintenance of remission.
Posology and method of administration
Mezavant XL is intended for once daily, oral administration. The tablets must not be crushed or chewed and should be taken with food. Adults, including the elderly (>65 years) <u>For induction of remission: ...
Contraindications
History of hypersensitivity to salicylates (including mesalazine) or any of the excipients of Mezavant XL. Severe renal impairment (GFR <30ml/min/1.73m²) and/or severe hepatic impairment.
Special warnings and precautions for use
Reports of renal impairment, including minimal change nephropathy, acute/chronic interstitial nephritis and renal failure have been associated with preparations containing mesalazine and pro-drugs of mesalazine. ...
Interaction with other medicinal products and other forms of interaction
Drug-drug interaction studies in healthy adult subjects have been conducted with Mezavant to investigate any effect of Mezavant on the pharmacokinetics and safety of three commonly used antibiotics. There ...
Fertility, pregnancy and lactation
Pregnancy Limited experience with mesalazine in pregnancy does not indicate an increased risk of drug induced congenital malformations. Mesalazine crosses the placental barrier, but provides foetal concentrations ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Mezavant is considered to have negligible influence on these abilities.
Undesirable effects
The most frequently reported adverse drug reactions (ADRs)within the pooled safety analysis of clinical studies with Mezavant, including 3,611 patients, were colitis (including ulcerative colitis) 5.8%, ...
Overdose
Mezavant is an aminosalicylate, and signs of salicylate toxicity include tinnitus, vertigo, headache, confusion, drowsiness, pulmonary oedema, dehydration as a result of sweating, diarrhoea and vomiting, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Aminosalicyclic acid and similar agents ATC code: A07EC02 Mechanism of action Mesalazine is an aminosalicylate. The mechanism of action of mesalazine is not fully understood, ...
Pharmacokinetic properties
The mechanism of action of mesalazine (5-ASA) is not fully understood but appears to be topical, and therefore the clinical efficacy of Mezavant does not correlate with the pharmacokinetic profile. A major ...
Preclinical safety data
Effects in nonclinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
List of excipients
<u>Tablet core:</u> Carmellose sodium Carnauba wax Stearic acid Silica, colloidal hydrated Sodium starch glycolate (Type A) Talc Magnesium stearate <u>Film-coating:</u> Talc Methacrylic acid – Methyl methacrylate ...
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
Store below 25°C. Store in the original package in order to protect from moisture.
Nature and contents of container
Tablets are packed in polyamide/aluminium/PVC foil blister packs with aluminium push-through foil. Packs contain 60 or 120 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Shire Pharmaceutical Contracts Ltd, 1 Kingdom Street, London, W2 6BD, United Kingdom
Marketing authorization number(s)
PL 08081/0040
Date of first authorization / renewal of the authorization
Date of first authorisation: 23<sup>rd</sup> February 2007 Date of last renewal: 13<sup>th</sup> December 2011
Date of revision of the text
April 2019
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