Gelfoam® - Pfizer

1 Gelfoam absorbable gelatin sponge, USPDESCRIPTIONGELFOAM Dental Sponges are small,sterile, surgical sponges preparedfrom specially treated and purifiedgelatin solution which is beaten todesired porosity, dried, sectioned,packaged, sealed, and sterilized by dry heat. GELFOAM is pliable, and is capable of absorbing and holding within itsmeshes many times its weight inwhole blood. It is used as a hemostatic implanted in tissues, GELFOAMD ental Sponges are completely absorbed within four to six weekswithout inducing excessive scar AND USAGEH emostasis:In oral and dentalsurgery, GELFOAM Dental Sponges arean aid in providing may be used either dry or moistened, depending upon conditions present at operation and preference of the surgeon.

2 Isotonic saline issuitable for use with not necessary, GELFOAM canbe used either with or without thrombin to obtain FOR USEWhen used dry, GELFOAM DentalSponges, cut to desired size, are rolledbetween the fingers and lightly compressed to the approximate diameterof the cavity or socket to be insertion of the rolled pack,light finger pressure should be appliedfor one or two used moistened, GELFOAM, cutto desired size, is immersed in thesolution of sodium chloride. The pieceis then removed from the solution,squeezed thoroughly to remove airbubbles present in the meshes, andreplaced in the solution where it willswell to its original size. It is thentaken from the solution, blotted onsterile gauze to remove excess fluid,and placed in the cavity or use with thrombin, consult the thrombin insert for complete prescribinginformation and proper sample Dental Sponges should notbe used in closure of skin incisionsbecause they may interfere with thehealing of skin not use GELFOAM Dental Sponges in patients with known allergies to product should not be resterilized by heat, because heating maychange absorption time.

3 Ethylene oxide is not recommended for resterilization because it may be trapped inthe interstices of the foam. Althoughnot reported for GELFOAM DentalSponges, the gas is toxic to tissue andin trace amounts may cause burns orirritation. Although the safety and efficacy of the combined use of GELFOAM with other agents such as topicalthrombin has not been evaluated incontrolled clinical trials, ifin the physician's judgment concurrent use of other agentsis medically advisable, the product literaturefor that agent should be consulted forcomplete prescribing is supplied as a sterile product and cannot be resterilized. Unused,opened envelopes of GELFOAM should be : To prevent contamination, employ aseptic procedure in opening envelope and withdrawing GELFOAM.

4 If the envelope is torn or punctured, the contained GELFOAM should not be of GELFOAM Dental Sponges is not recommended in presence offrank infection. If signs of infection orabscess develop in an area whereGELFOAM has been placed, reoperationmay be necessary to remove infectedmaterial and allow absorbing fluid, GELFOAM mayexpand and impinge on neighboringstructures. Therefore, when placedinto cavities or closed tissue spaces,minimal preliminary compression isadvised and care should be exercisedto avoid over 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 REACTIONSA lthough sterile, GELFOAM DentalSponges may form a nidus of infectionand SUPPLIEDGELFOAM Dental Sponges are available inSize 4(2 x 2 cm) envelopes of2 spongesGTIN 00300090396053 (0009-0396-05)STORAGE AND HANDLINGGELFOAM Dental Sponges should bestoredat 25 C (77 F).

5 Excursions permitted to 15-30 C (59-86 F) [see USPC ontrolled Room Temperature]. Oncethe package is opened, contents aresubject to contamination. It is recommended that GELFOAM be used assoon as the package is opened andunused contents product is prepackaged sterile and intended only for single can result in transmission of bloodborne pathogens (including HIV and hepatitis), potentially endangering patientsand health care providers. Adherence to the principles of aseptic technique when using this product is :Federal law restricts thisdevice to sale by or on the order of adentist or product s label may have been updated. For current full prescribing information, please visit NOT RE-USEM ethod of sterilization using steam or dry heatAttention, see instructions for useCONSULT Instructions for UseDO NOT RESTERILIZEDO NOT USE IF PACKAGE IS DAMAGEDM anufactured by:Pharmacia and Upjohn Company 7000 Portage RoadKalamazoo, December2014