Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
Avondale Pharmaceuticals, LLC
TOPICAL
For prescription use only. Protyl Ag is indicated for the treatment of partial and full thickness wounds, including; - pressure injuries (Stages 1-4) - diabetic ulcers - grafted wounds and donor sites - surgical wounds - superficial wounds - venous stasis ulcers - first and second degree burns - traumatic wounds - ulcers resulting from arterial insufficiency Contraindicated for individuals with a known sensitivity to silver.
Protyl Ag Rx Wound Gel is available in a 42g tube, NDC 71740-010-42. Store at room temperature (59˚F - 86˚F) and protect from freezing. Extreme temperatures may affect viscosity, but will not affect performance of the product.
Premarket Notification
PROTYL AG- DRESSING, WOUND, DRUG GEL AVONDALE PHARMACEUTICALS, LLC ---------- PROTYL AG™ RX WOUND GEL (hyCURE is a unique Type 1 Bovine Hydrolyzed Collagen; 1% Silver Oxide) INDICATIONS For prescription use only. Protyl Ag is indicated for the treatment of partial and full thickness wounds, including; pressure injuries (Stages 1-4) diabetic ulcers grafted wounds and donor sites surgical wounds superficial wounds venous stasis ulcers first and second degree burns traumatic wounds ulcers resulting from arterial insufficiency DESCRIPTION Protyl Ag is an absorbent hydrolyzed collagen gel for the management of exudative wounds. It provides a physiologically favorable moist wound environment for wound healing. Protyl Ag absorbs excess wound exudate. Protyl Ag is made from natural materials that contain the proteins and amino acids that constitute the major building blocks of normal skin and connective tissue as well as silver as a preservative to control bacterial growth within the gel. Protyl Ag provides a physiologically favorable environment that encourages wound healing and conforms to the wound site. It is easy to use, biocompatible and biodegradable. Protyl Ag supports natural autolysis by rehydrating and softening necrotic tissue and eschar thereby encouraging autolytic debridement. The silver preservative in the dressing controls microbial growth within the gel. PRODUCT ADMINISTRATION Cleanse the wound site using normal saline or sterile water. Apply a layer of gel directly into the wound site and onto the surrounding area. Cover the wound with a non-adherent dressing. Reapply gel and redress as needed. Superficial wounds such as cuts and abrasions may not require a secondary dressing due to the film that the gel forms on the wound site after drying. Dressing may be moistened with sterile water or normal saline to ease removal. ® CAUTION In case of deep or puncture wounds or serious burns, consult a physician. If redness, irritation, swelling or pain persists or increases or if infection occurs, discontinue Прочитајте комплетан документ