Negara: Italia
Bahasa: Italia
Sumber: Ministero della Salute
CYTORI THERAPEUTICS INC
Il sistema Celution 830/CRS include uno ciascuno dei seguenti prodotti: Celution 805/CRS Consumable Set, Celase, 35 mg, Cytori 200/CK Procedure Pack, Puregraft 250/PURE System
In commercio
2012-01-24
CELASE® 835/CRS, 35 MG Instructions for Use Mode d’emploi Gebrauchsanleitung Instrucciones de uso Istruzioni per l'uso Aanwijzingen voor gebruik IN50075_L Effective: 2015-04 Page 1 of 2 DESCRIPTION The Cytori Therapeutics Celase ® 835/CRS reagent is a blended proteolytic enzyme used to dissociate adipose tissue in order to release the Adipose-Derived Regenerative Cells (ADRCs) using the Cytori Therapeutics Celution ® System. Celase 835/CRS is a mixture of highly purified collagenase and neutral protease enzymes, formulated for efficient, gentle, and reproducible dissociation of nucleated cells from their surrounding tissue matrix (i.e., adipose tissue). The target substrates for the Celase enzyme blend are the collagen and non-collagen proteins that comprise the extracellular matrix and entrap the stem cells and associated progenitor cells. Celase 835/CRS has been aseptically processed, sterile filtered, and highly purified to assure the lowest levels of impurities (i.e., endotoxins). Celase is provided as a single-use unit which consists of a clear glass vial within a protective canister. FORMULATION Celase 835/CRS is a white lyophilizate consisting of aseptically filled, blended enzymes, and a small quantity of buffer salts. INTENDED USE Celase 835/CRS is intended for use exclusively with the Celution 800/CRS Device to digest and liquefy the adipose tissue matrix for the purpose of releasing stromal stem cells and associated progenitor cells from the adipose tissue matrix. PROCEDURE 1) Reconstitute the Celase 835/CRS reagent into stock solution as follows: NOTE: DO NOT USE BACTERIOSTATIC WATER FOR INJECTION. THIS TYPE OF WATER CONTAINS PRESERVATIVES THAT INHIBIT COLLAGENASE ENZYME ACTIVITY. a. Remove the plastic cap and swab rubber septum with alcohol wipe. b. Using a sterile needle and syringe, pierce the rubber septum and add 5 mL sterile Lactated Ringer’s to the vial of 35 mg Celase 835/CRS. Note: Reconstitute the entire vial. Do not weigh individual aliquots of the lyophilizate. The introduction of m Baca dokumen lengkapnya