Important Safety Information
Indication: Collagenase SANTYL Ointment (“SANTYL”) is indicated for debriding chronic dermal ulcers and severely burned areas.
Contraindications: SANTYL is contraindicated in patients who have shown local or systemic hypersensitivity to collagenase.
Warnings and Precautions: The optimal pH range of collagenase is 6 to 8. Higher or lower pH conditions will decrease the enzyme’s activity and appropriate precautions should be taken. The enzymatic activity is also adversely affected by certain detergents, and heavy metal ions such as mercury and silver which are used in some antiseptics. As such, the wound should be properly cleansed prior to application of SANTYL. Debilitated patients should be closely monitored for systemic bacterial infections because of the theoretical possibility that debriding enzymes may increase the risk of bacteremia. A slight transient erythema has been noted occasionally in the surrounding tissue, particularly when SANTYL was not confined to the wound. SANTYL is not indicated for wound closure. Discontinue use of SANTYL after granulation tissue is well-established.
Adverse Reactions: No allergic sensitivity or toxic reactions have been noted in clinical use when used as directed. The risk information provided herein is not comprehensive.
To see the complete Prescribing Information, please see the FDA-approved product labeling. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.
The products used in the T.I.M.E. clinical decision support tool may vary in different markets. Not all products referred to may be approved for use or available in all markets. Please consult your local Smith & Nephew representative for further details on products available in your market.
*Refer to precautions: only the 45-degree VERSAJET II Exact instrument is suitable for use outside of the operating room – conditions apply to use. Please refer to the Instruction for Use.
**Use appropriate secondary dressings according to your local protocol.
A healthcare professional must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Smith & Nephew does not dispense medical advice and recommends that healthcare professionals be trained in the use of any particular product before using it on patients.
For detailed product information, including indications for use, contraindications, effects, precautions, warnings, and important safety information, please consult the Instructions for Use (IFU) prior to use.