Pays: Biélorussie
Langue: russe
Source: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Carnamedica Sp. z o.o., ПОЛЬША
изделия медицинского назначения
Carnamedica Sp. z o.o. (контрактное производство в Польше)
2018-08-30
INSTRUCTIONS FOR USE EN PlegiStore ® Container with perfusion and preservation solution for organs intended for transplantation IfU/PLST/en/2020/01/07 CARNAMEDICA SP. Z O.O. ul. Olszynki Grochowskiej 21 lok. U6 04-281 Warsaw, Poland 2 EN INSTRUCTIONS FOR USE Container contents: Solution for perfusion and cold storage of organs for transplantation PlegiStore ® Bretschneider’s Histidine – Tryptophan – Ketoglutarate Solution STERILE AND NON-PYROGENIC SOLUTION FOR PERFUSION AND COLD STORAGE OF ORGANS FOR TRANSPLANTATION NOT INJECTABLE Description: Composition: 1000 ml solution contains: sodium chloride 0.8766 g 15.0 mmol/l potassium chloride 0.6710 g 9.0 mmol/l magnesium chloride · H 2 O 0.8132 g 4.0 mmol/l histidine hydrochloride · H 2 O 3.7733 g 18.0 mmol/l histidine 27.9289 g 180.0 mmol/l tryptophan 0.4085 g 2.0 mmol/l mannitol 5.4651 g 30.0 mmol/l calcium chloride · H2O 0.0022 g 0.015 mmol/l potassium hydrogen 2-oxopentandioate 0.1842 g 1.0 mmol/l Potassium hydroxide 2N to pH adjustment q.s. Water for injection q.s. 1.000 ml Physical properties: pH: 7.02-7.20 at 25° C; 7.40-7.45 at 4° C; Osmolality: 310 mOsm/kg Type of device and mode of action: Electrolyte and amino acid aqueous solution for organ perfusion and preservation. Cardiac arrest by electromechanical decoupling. Organ protection, preservation and conservation. Surface cooling of organs (heart, kidney, liver, lung, pancreas). Protection of vessel grafts. Indications: In cardioplegia (multi organ protective irrigation) in connection with heart surgery, organ protec- tion during operations under ischemia (heart, kidney, liver), preservation of organs for transplantation with venous or arterial segments (heart, kidney, liver, lung, pancreas). The solution should be used only by medical healthcare staff, adequately trained, according to established operating protocols. Contraindications: None known at present. Precautions and warnings: Histidine – Tryptophan – Ketoglutarate solution is not intended for intravenous or intraarterial administr Lire le document complet