absorbable gelatin sponge, USP
GELFOAM Dental Sponges are small, sterile, surgical sponges prepared from specially treated and purified gelatin solution which is beaten to desired porosity, dried, sectioned, packaged, sealed, and sterilized by dry heat. GELFOAM is pliable, and is capable of absorbing and holding within its meshes many times its weight in whole blood. It is used as a hemostatic device.
In oral and dental surgery, GELFOAM Dental Sponges are an aid in providing hemostasis. GELFOAM may be used either dry or moistened, depending upon conditions present at operation and preference of the surgeon. Isotonic saline is suitable for use with GELFOAM. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
DOSAGE AND ADMINISTRATION
Directions For Use
When used dry, GELFOAM Dental Sponges, cut to desired size, are rolled between the fingers and lightly compressed to the approximate diameter of the cavity or socket to be filled. Following insertion of the rolled pack, light finger pressure should be applied for one or two minutes.
When used moistened, GELFOAM, cut to desired size, is immersed in the solution of sodium chloride. The piece is then removed from the solution, squeezed thoroughly to remove air bubbles present in the meshes, and replaced in the solution where it will swell to its original size. It is then taken from the solution, blotted on sterile gauze to remove excess fluid, and placed in the cavity or wound. For use with thrombin, consult the thrombin insert for complete prescribing information and proper sample preparation.
GELFOAM Dental Sponges are available in Size 4 (2 x 2 cm) envelopes of 2 sponges GTIN 00300090396053 (0009-0396-05)
Storage And Handling
GELFOAM Dental Sponges should be stored at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Once the package is opened, contents are subject to contamination. It is recommended that GELFOAM be used as soon as the package is opened and unused contents discarded.
This product is prepackaged sterile and intended only for single use. Reuse can result in transmission of bloodborne pathogens (including HIV and hepatitis), potentially endangering patients and health care providers. Adherence to the principles of aseptic technique when using this product is essential.
Federal law restricts this device to sale by or on the order of a dentist or physician.
Manufactured by: Pharmacia and Upjohn Company, 7000 Portage Road, Kalamazoo, Michigan 49001, USA, 1-800-253-8600. Distributed by: Pharmacia & Upjohn Co., Division of Pfizer Inc., New York, NY 10017. Revised December 2014
This product should not be resterilized by heat, because heating may change absorption time. Ethylene oxide is not recommended for resterilization because it may be trapped in the interstices of the foam. Although not reported for GELFOAM Dental Sponges, the gas is toxic to tissue and in trace amounts may cause burns or irritation.
Although the safety and efficacy of the combined use of GELFOAM with other agents such as topical thrombin has not been evaluated in controlled clinical trials, if in the physician's judgment concurrent use of other agents is medically advisable, the product literature for that agent should be consulted for complete prescribing information.
GELFOAM is supplied as a sterile product and cannot be resterilized. Unused, opened envelopes of GELFOAM should be discarded. WARNING: To prevent contamination, employ aseptic procedure in opening envelope and withdrawing GELFOAM. If the envelope is torn or punctured, the contained GELFOAM should not be used.
Use of GELFOAM Dental Sponges is not recommended in presence of frank infection. If signs of infection or abscess develop in an area where GELFOAM has been placed, reoperation may be necessary to remove infected material and allow drainage.
By absorbing fluid, GELFOAM may expand and impinge on neighboring structures. Therefore, when placed into cavities or closed tissue spaces, minimal preliminary compression is advised and care should be exercised to avoid over packing.
Positioning of the patient resulting in negative peripheral venous pressure during a procedure has been reported to be a contributing factor resulting in life-threatening thromboembolic events.
Report Problems to the Food and Drug Administration
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