Samples of the donor skin are tested for and shown to be free of bacterial
Cymetra® Micronized AlloDerm® Tissue is micronized donated allograft
and fungal pathogens; non-pathogenic skin bacteria may be present.
human dermis, aseptically processed to remove cells and freeze-dried to remove moisture while preserving biologic components and structure of
Due to limitations in testing technology, testing and donor screening
cannot totally eliminate the risk that human source material will transmit disease.
Cymetra® Micronized Tissue is regulated by the US Food and Drug Administration (FDA) as human tissue for transplantation. Cymetra®
Cymetra® Micronized AlloDerm® Tissue is intended for homologous
Micronized Tissue is processed and marketed in accordance with the FDA’s
use when transplanted into sub-epidermal spaces from which such
requirements for banked human tissue (21 CFR, Part 1271) and Standards
tissue originates, for repair or replacement of damages or inadequate
for Tissue Banking of the American Association of Tissue Banks (AATB).
integumental tissues (e.g., correct soft-tissue defects, and depressed scars,
Cymetra® Micronized Tissue is compliant with the AATB Standards for
or for replacement of integumental tissue lost through atrophy).
Tissue Banking and the state guidelines of California, Florida, New York,
Each package of Cymetra® Micronized Tissue is intended for use in one
LifeCell™ has determined the donor of this tissue graft to be an eligible
Cymetra® Micronized Tissue is contraindicated for use in any patient who is
donor based on the results of donor screening and testing records and
sensitive to polysorbate 20 or any of the antibiotics listed on the package.
thereby declares the tissue to be safe for transplantation. Donor screening includes, but may not be limited to, review of relevant medical records
DO NOT USE Cymetra® Micronized Tissue in the periocular, forehead
including a current donor risk assessment interview; a physical examination
or glabellar areas. If Cymetra® Micronized Tissue is used in these areas,
of the donor; laboratory test results; existing coroner and autopsy
there is a risk of the Cymetra® Micronized Tissue entering and occluding
results; as well as other information pertaining to risk factors for relevant
blood vessels supplying the eye through retrograde flow, resulting in vision
Donor screening and testing is performed on all tissue donors according to FDA regulations and AATB standards. Refer to the Summary of Records label provided with each graft for details of the testing. DO NOT USE the Cymetra® Micronized Tissue if prior to rehydration it is not uniformly white to buff in coloration.
Processing of the tissue, laboratory testing and careful donor
DO NOT USE the Cymetra® Micronized AlloDerm® Tissue if it has
screening minimize the risks of the donor tissue transmitting disease
to the recipient patient. As with any processed donor tissue, the Cymetra® Micronized AlloDerm® Tissue cannot be guaranteed to be
Use of Cymetra® Micronized Tissue is limited to specific healthcare
free of all pathogens. No long-term studies have been conducted
professionals or practitioners (e.g., physicians).
to evaluate the carcinogenic or mutagenic potential or reproductive impact of the clinical application of the Cymetra® Micronized Tissue.
Unused or expired product should be discarded according to local institutional requirements.
• DO NOT RE-USE Cymetra® Micronized Tissue.
Failure to follow rehydration instructions may lead to sub-optimal results.
• DO NOT STERILIZE Cymetra® Micronized Tissue.
Aseptic technique must be adhered to throughout the procedure.
• DO NOT USE Cymetra® Micronized Tissue if the foil pouch is perforated
or torn. A damaged pouch may result in degradation or contamination
Cymetra® Micronized Tissue should be used within two hours following
• The foil pouch that contains the Cymetra® Micronized Tissue is NOT
Use the supplied 23-gauge needle for implanting rehydrated Cymetra®
STERILE. DO NOT PLACE the foil pouch in the sterile field.
Micronized Tissue. Use of a smaller gauge needle may increase the risk of the needle clogging.
PrecautionsPoor general medical condition or any pathology that would limit the
If the needle should become clogged during insertion, replace with a fresh
blood supply and compromise healing, as well as nonvascular surgical
sites, should be considered when selecting patients for implanting
Gentle massage by the physician of the treated area is recommended
Cymetra® Micronized Tissue as such conditions may compromise successful
during and following treatment to achieve symmetry. The patient should
implantation or lead to sub-optimal results.
NOT massage the treated area. Transient swelling, redness and firmness
Whenever clinical circumstances require implantation in a site that is
can be expected to occur following treatment.
contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken.
Adverse effectsPotential adverse effects which may result from placement of an implant or graft include, but are not limited to the following: wound or systemic infection; hypersensitive, allergic or other immune response; rapid resorption of graft material; and disease transmission.
Because Cymetra® Micronized AlloDerm® Tissue is placed into a superficial
subdermal tissue plane, there is potential for swelling, bruising, pain
Important: It is the responsibility of the healthcare professional or
or irritation during the immediate post-operative period. Skin redness,
practitioner to maintain recipient records for the purpose of tracing tissue
discoloration and herpetic lesions have been reported on rare occasions.
post-implantation. Patient tracking labels are provided for convenience.
These symptoms typically resolve without sequelae. In addition, lumpiness and a non-uniformity of contour may occur if care is not taken by the
Prepare treatment area for injection. If the injection site is susceptible to
physician to evenly distribute the material during placement. Firmness of
herpetic outbreak, the patient may be placed on prophylactic antiviral
the treated site may occur within the first 4 months, but typically resolves
agents. See “Preparation for placement” for anesthetic options.
Instructions for optimal rehydration are separately enclosed in the
Adverse outcomes potentially attributed to Cymetra® Micronized Tissue
Cymetra® Micronized AlloDerm® Tissue package. Failure to follow
must be reported promptly to LifeCell™ Corporation.
rehydration instructions may lead to sub-optimal results.
Refrigerate upon receipt between 1–10˚C (34–50˚F). The expiration date for
Cymetra® Micronized Tissue should be placed into a superficial sub-
the Cymetra® Micronized Tissue is recorded on the outer package as a year
dermal tissue plane. Cymetra® Micronized Tissue has been formulated
(4 digits) and month (2 digits), the product expires on the last day of the
to a consistency that will easily pass through a 23-gauge needle. Use
month indicated. Do not use product after expiration date.
of a smaller gauge needle may increase the risk of the needle clogging. Preparation of the injection site can be achieved using a variety of
Expiration date printed on the labeling is valid as long as product is stored
approaches to help maximize patient comfort during and after the
refrigerated and in an unopened foil bag.
placement of tissue, including: • Topical anesthetics such as lidocaine/prilocaine cream; • Regional nerve block; and
• Lidocaine with epinephrine, or ice placed on the site 2-3 minutes prior
Cymetra® Micronized Tissue is supplied as a dried, acellular dermal
to detection. (The use of lidocaine with epinephrine may alter the clinical
particulate. The Cymetra® Micronized Tissue package includes standard
endpoints of certain procedures such as laser resurfacing if concurrently
disposable supplies to facilitate rehydration and delivery. Refer to product
rehydration Instructions for contents.
Tissue Transplant Return RecordThe Tissue Transplant Return Record (TTRR) is attached to the Instructions for Use. Please separate the TTRR from the Instructions for Use and follow the directions provided on the form for completion and return to LifeCell™ Corporation.
InquiriesContact LifeCell™ Customer Support at 908.947.1215 or 800.367.5737, or e-mail LifeCell™ at [email protected] for additional information, to place an order, or to report adverse reactions.
Cymetra® Micronized AlloDerm® Tissue is processed and distributed by LifeCell™ Corporation, One Millennium Way, Branchburg, NJ 08876 USA.
This product and certain methods are covered by U.S. and foreign patents and patents pending. LifeCell Corporation One Millennium Way, Branchburg, NJ 08876 Tel: 908.947.1100 Fax: 800.226.2714 LifeCell™ Customer Support 800.367.5737 www.lifecell.com
Copyright 2012 LifeCell Corporation. All rights reserved. LifeCell™, AlloDerm® and Cymetra® are trademarks of LifeCell Corporation. LifeCell Corporation holds Canadian Registration #100128.
Tel/Fax (0351) 464 5938 WWW.HIPODROMOCORDOBA.COM.AR PROGRAMA NO OFICIAL Domingo 18 de Diciembre de 2011 Reunión Nº 10 PROGRAMA SUJETO A CAMBIOS. ACCESO EXCLUSIVO POR ENTRADA PRINCIPAL 1 º Carrera Apuestas a Ganador, Segundo, Exacta, Imperfecta y Trifecta CONCERTADA Premios: $150 P.C.C.- Insc. $150 R.O. $150 Der Prog $40 Procedencia Padre - Madre Cuidador
Formerly Aw l W eave Ghat The Newsletter of the American Association on Intellectual and Developmental Disorders’ (AAIDD) Humanist Action Group – December, 2007 v.1 issue 4 This newsletter expresses the opinion of this subgroup and not necessarily of AAIDD All data presented are opinions and alternative opinions may be printed in later issues. Send feedback and submissions