দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
PENTOXIFYLLINE
Sanofi-Aventis Ireland Limited
400 Milligram
Modified-release Tablets
1977-03-07
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Trental 400 mg Modified-Release, Coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400 mg of pentoxifylline. Excipients: Sucrose 141.88 mg. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Modified-release, coated tablet. Oblong, pink tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS USES: Trental 400 is indicated in the management of peripheral vascular disease. Trental has been shown to increase cerebral blood flow but this may not necessarily be accompanied by an improvement in clinical signs and symptoms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended initial dose is 1 tablet (400mg) three times daily; two tablets daily may prove sufficient in some patients, particularly for maintenance therapy. _Elderly_: No special dosage requirements. Children: No experience is available concerning the use of pentoxifylline in children. Consequently Trental 400mg is not currently recommended for use in children. Special Cases: In patients with impairment of renal function (creatinine clearance below 30ml/min) a dose reduction by approx. 30% to 50% may be necessary – guided by individual tolerance, see section 4.4 A dose reduction-guided by individual tolerance- is necessary in patients with severely impaired liver function, see section 4.4. Treatment must be started at low-dose levels in hypotensive patients or patients whose circulation is unstable as well as in patients, who would be at particular risk from a reduction in blood pressure (e.g. patients with severe coronary heart disease or relevant stenoses of blood vessels supplying the brain); in such cases, the dose must only be increased gradually, see section 4.4. 4.3 CONTRAINDICATIONS Trental 400 is সম্পূর্ণ নথি পড়ুন