PepFactor Mandatory

Read this entire package insert carefully prior to use. Single patient use only, on a single visit. Restricted to sale by or on the order of a physician or Licensed Medical Professional. Only qualified licensed professionals should treat their patients/clients with the PepFactor™ product. Growth factors (GFs) are signaling proteins that affect cellular processes such as growth, proliferation, and differentiation. GFs are used as cosmeceuticals, exerting anti-wrinkle, anti-aging, and whitening effects, and as pharmaceuticals to treat wounds, growth failure, and oral mucositis. ReGen Factor PepFactor™ contains 50 micrograms of recombinant human Basic. PepFactor™ per 5ml freeze dried PepFactor™ 5 ml vial. PepFactor™ is processed using proprietary techniques to produce cost-effective, bioidentical rh bFGF. This product provides natural cell to cell communication signals to support local tissue repair. ReGen Factor assumes no responsibility for the clinical use of this product; the licensed healthcare professional determines the administration and method of use. Warranty These basic Fibroblast Growth Factors are processed under cGMP standards. This product is unique and does not constitute a surgical product under liability laws. No implied warranties of merchantability or fitness for a specific purpose are applicable. No implied warranties exist as to defects in biologics, which cannot be detected, removed, or prevented by reasonable use of available scientific procedures or techniques. Furthermore, all warranties are disclaimed, whether expressed or implied by operation of law or otherwise including all implied warranties of merchantability or fitness for a particular purpose. Warnings Same and similar potential medical/surgical, conditions or complications that apply to any surgical procedure may occur during or following usage or application of PepFactor™. The physician or surgeon is responsible for informing patient of the risks associated with their treatment and the possibility of complications or adverse reactions. As with any procedure, the potential for transmission of infectious agents may exist. Precautions Prior to use, the practitioner must become familiar with the product and the treatment procedure. PepFactor™ should be used with considerable caution in sites where an active infection is present, in necrotic sites or in sites with poor perfusion. This product is intended for homologous use only. Appropriate delivery of PepFactor™ is critical for successful outcomes. If the container seal is damaged or not intact or has any physical damage; If the container label is severely damaged, not legible or is If the expiration date shown on the container label has passed. Processing In mammalian and bacterial cells, low productivity and expression in inclusion bodies, respectively, of competitor GFs does not satisfy the consumer demand. ReGen Factor has developed a bacterial expression system that produces high yields of soluble and bioidentical GFs that can be purified in their native forms. The product is meticulously processed and packaged in an aseptic environment, every precaution has been taken and exercised to insure the absence of any bioburden. Contraindications The presence of skin and other cancers, active or latent infection, or uncontrolled infection at the site excludes the patient from treatment. Storage and Shipping This product is supplied as a freeze-dried powder in 5ml glass vials and can be stored below 30°C for up to 2 years. or between -20°C and -40°C for up to 6 months. The product must be stored while it is still frozen. PepFactor™ should not be stored in liquid nitrogen as storage vials are not rated for ultra-cold storage. Packaging and Labeling PepFactor™ is aseptically processed. The product is sealed, labeled and placed inside a product box with this IFU. This product must not be used under any of the following circumstances: Missing or; Once a container seal has been compromised, the PepFactor™ shall be discarded. The PepFactor™ Package card, which has a postage paid return label pre-printed on it, should be completed and returned if the PepFactor™ vial is used or discarded for tracking purposes. Disclaimer: It is the responsibility of the End-User clinician to maintain PepFactor™ kits in appropriate storage conditions and temperatures. Recipient records must be maintained for tracing PepFactor™ post-administration, and the PepFactor™ Tracking Record (PTR) returned to ReGen Factor. ReGen Factor Pty Ltd, will not be liable for any damages, whether direct or indirect, special, incidental, or consequential, resulting from improper storage or use of this product. The instructions for use are specific, and ReGen Factor waives all responsibility associated with mishandling, inappropriately storing, and/or not taking proper precautions with the product included with this insert. DESCRIPTION AND STORAGE CONDITIONS For homologous use on a single visit/surgery/episode for a single patient, it cannot be shared. Do not use: If past expiration date specified on the product label. If the packaging is damaged. If there are discrepancies in label information. To prevent contamination, use sterile technique for preparation and administration. Do not sterilize or re-use after mixing. Use standard practices for handling and disposal. Promptly report all complaints and patient adverse events to ReGen Factor. Take photographs, maintain packaging and labels if possible and document any concerns. Outer packaging is not sterile, only the product inside the vial is considered sterile. Open packaging using aseptic technique. Open the PepFactor™ vial containing the bFGF. Open the vial containing the mixing liquid, Hyaluronic acid for PepFactor Skin™ treatments. Open the vial containing the mixing liquid, Copper Peptide for PepFactor Scalp™ treatments. Pour the liquid into the freeze-dried vial containing the PepFactor™. Replace the cap on the mixed product and shake well foe 30 seconds. Use a sterile needle and syringe to draw the PepFactor Skin™ or PepFactor Scalp™ mixture into a Syringe. Apply the PepFactor Skin™ or PepFactor Scalp™ mixture to the treatment area as determined necessary. Use a Micro needling device with to infuse the PepFactor™ product into the treatment area. Only use sterile, new micro needling needles for each treatment. Discard of micro needling needles after use in an appropriate manner. Physician experience and knowledge are key to proper application and usage of product. If unsure as to appropriate application, do not use until fully informed as to protocol and technique from an experienced user. Contact your sales representative or customer service for more info. Fill out the Tissue Tracking Record card (even if the PepFactor™ is discarded) and return to ReGen Factor. This information is an FDA requirement and is kept confidential and used only for product tracking. Follow your patient and inform ReGen Factor of any adverse events, concerns, or questions immediately by contacting your sales representative or customer service. It is important to read and understand the following instructions prior to clinical use. Improper preparation technique may adversely affect handling properties. Universal Precautions should be used when handling the product. General instructions: 1. 2. a. b. c. 3. 4. 5. 6. 7. 8. a. b. c. d. e. f. g. h. i. j. 9. 10. 11. If the product received is defective, please document and take photographs to document damage, defects, or deficiencies, and send to ReGen Factor via email immediately. Call the number below to report the issue to customer service. The product issue or concern will be reviewed, and the product will be appropriately replaced or refunded. Customer Returns and Concerns Disclaimer: It is the responsibility of the End-User