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discolorazioni ungueali,onicolisi -
discolouration, onycholysis
Last Update: 2008-03-04
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le seguenti modificazioni, osservate in ratti e macachi trattati con l' associazione irbesartan/ idroclorotiazide a 10/ 10 e a 90/ 90 mg/ kg/ die sono state anche osservate con uno dei due medicinali in monoterapia e/ o erano secondarie a diminuzioni della pressione arteriosa (non sono state osservate interazioni tossicologiche significative): modificazioni renali, caratterizzate da lievi aumenti dell’ uricemia e della creatininemia, e da iperplasia/ ipertrofia dell’ apparato juxtaglomerulare, che sono una conseguenza diretta dell’ interazione di irbesartan col sistema renina-angiotensina; lievi diminuzioni dei parametri eritrocitari (eritrociti, emoglobina, ematocrito); discolorazioni gastriche, ulcere e necrosi focali della mucosa gastrica sono state osservate in pochi ratti in uno studio di tossicità a 6 mesi con irbesartan somministrato alla dose di 90 mg/ kg/ die, idroclorotiazide 90 mg/ kg/ die e irbesartan/ idroclorotiazide 10/ 10 mg/ kg/ die.
the following changes, observed in rats and macaques receiving the irbesartan/ hydrochlorothiazide combination at 10/ 10 and 90/ 90 mg/ kg/ day, were also seen with one of the two medicinal products alone and/ or were secondary to decreases in blood pressure (no significant toxicologic interactions were observed): kidney changes, characterized by slight increases in serum urea and creatinine, and hyperplasia/ hypertrophy of the juxtaglomerular apparatus, which are a direct consequence of the interaction of irbesartan with the renin-angiotensin system; slight decreases in erythrocyte parameters (erythrocytes, haemoglobin, haematocrit); stomach discoloration, ulcers and focal necrosis of gastric mucosa were observed in few rats in a 6 months toxicity study at irbesartan 90 mg/ kg/ day, hydrochlorothiazide 90 mg/ kg/ day, and irbesartan/ hydrochlorothiazide 10/ 10 mg/ kg/ day.
Last Update: 2012-04-12
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