CELUTION 830/CRS SINGLE PROCEDURE PACK

Nazione: Italia

Lingua: italiano

Fonte: Ministero della Salute

Commercializzato da:

CYTORI THERAPEUTICS INC

Dettagli prodotto:

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

Stato dell'autorizzazione:

In commercio

Data dell'autorizzazione:

2012-01-24

Foglio illustrativo

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