Kraj: Włochy
Język: włoski
Źródło: Ministero della Salute
INVENTIS SRL
N
2011-04-01
4 GB PRODUCT DESCRIPTION SPONGOSTAN™ Absorbable Haemostatic Gelatin Sponge is a sterile, water-insoluble, malleable, porcine gelatin absorbable sponge intended for haemostatic use by applying to a bleeding surface. The sponge is off-white and porous in appearance. ACTIONS When used in appropriate amounts SPONGOSTAN™ Sponge is absorbed completely within 4 to 6 weeks. In an animal implantation study, tissue reactions were classified as negligible when observed macroscopically, and moderate when observed microscopically with SPONGOSTAN™ Sponge. When applied to bleeding mucosal regions, it liquefies within 2 to 5 days. INTENDED USE/INDICATIONS SPONGOSTAN™ Sponge, used dry or saturated with sterile sodium chloride solution, is indicated for surgical procedures (except ophthalmic) for haemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical. Although not necessary, SPONGOSTAN™ Sponge can be used with thrombin to achieve haemostasis. † CONTRAINDICATIONS Do not use SPONGOSTAN™ Sponge in closure of skin incisions because it may interfere with the healing of skin edges. This interference is due to mechanical interposition of gelatin and is not secondary to intrinsic interference with wound healing. Do not use SPONGOSTAN™ Sponge in intravascular compartments because of the risk of embolization. Do not use SPONGOSTAN™ Sponge in patients with known allergies to porcine collagen. WARNINGS • SPONGOSTAN™ Sponge is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for haemostasis. • SPONGOSTAN™ Sponge should not be used in the presence of infection. SPONGOSTAN™ Sponge Przeczytaj cały dokument