SURGIFOAM is a sterile‚ water-insoluble‚ malleable‚ porcine gelatin absorbable sponge or powder intended for hemostatic use by applying to a bleeding surface․ The sponge is off-white and porous in appearance․ SURGIFOAM is absorbed completely within 4 to 6 weeks when used in appropriate amounts․ When applied to bleeding mucosal regions‚ it liquefies within 2 to 5 days․ SURGIFOAM should be removed from the site of application when used in‚ around‚ or in proximity to foramina in bone‚ areas of bony confine‚ the spinal cord‚ and/or the optic nerve and chiasm․ The safety and effectiveness of SURGIFOAM for use in ophthalmic procedures have not been established․
Introduction
SURGIFOAM Absorbable Gelatin Sponge‚ U․S․P․ is a sterile‚ water-insoluble‚ malleable‚ porcine gelatin absorbable sponge intended for hemostatic use by applying to a bleeding surface․ The sponge is off-white and porous in appearance; SURGIFOAM Sponge has hemostatic properties․ SURGIFLO fills and envelops bleeding sites to stop bleeding fast․ SURGIFLO maintains uniform viscosity better from beginning to end than FLOSEAL3․ Based on in vitro viscosity testing of SURGIFLO 8 mL and FLOSEAL Hemostatic Matrix 5 mL; each product was prepared following Instructions for Use․ SURGIFOAM is a sterile water-soluble‚ porcine-based gelatin sponge wound dressing designed to be absorbed by the body․ For hemostatic use‚ SURGIFOAM dressings should be applied directly to a bleeding surface‚ where it will integrate with the body over the next few days․ SURGIFOAM Sponge‚ used dry or saturated with sterile sodium chloride solution‚ is indicated for surgical procedures (except ophthalmic) for hemostasis‚ when control of capillary‚ venous and arteriolar bleeding by pressure‚ ligature and other conventional procedures is ineffective or impractical․ SURGIFOAM‚ used dry or saturated with sterile sodium chloride solution‚ is indicated for surgical procedures (except ophthalmic) for hemostasis‚ when control of capillary‚ venous and arteriolar bleeding by pressure‚ ligature and other conventional procedures is ineffective or impractical․ SURGIFOAM Absorbable Hemostatic Gelatin Sponges‚ USP‚ are available in the following size⁚ Please note that all SURGIFOAM Absorbable Gelatin Sponges may not be approved for use in countries outside of the United States and Canada․ SURGIFOAM Powder‚ saturated with sterile sodium chloride solution‚ is indicated for surgical procedures (except ophthalmic) for hemostasis‚ when control of capillary‚ venous and arteriolar bleeding by pressure‚ ligature and other conventional procedures is ineffective or impractical․
Indications for Use
SURGIFOAM Sponge‚ used dry or saturated with sterile sodium chloride solution‚ is indicated for surgical procedures (except ophthalmic) for hemostasis‚ when control of capillary‚ venous and arteriolar bleeding by pressure‚ ligature and other conventional procedures is ineffective or impractical․ SURGIFOAM‚ used dry or saturated with sterile sodium chloride solution‚ is indicated for surgical procedures (except ophthalmic) for hemostasis‚ when control of capillary‚ venous and arteriolar bleeding by pressure‚ ligature and other conventional procedures is ineffective or impractical․ SURGIFOAM Absorbable Hemostatic Gelatin Sponges‚ USP‚ are available in the following size⁚ Please note that all SURGIFOAM Absorbable Gelatin Sponges may not be approved for use in countries outside of the United States and Canada․ SURGIFOAM Powder‚ saturated with sterile sodium chloride solution‚ is indicated for surgical procedures (except ophthalmic) for hemostasis‚ when control of capillary‚ venous and arteriolar bleeding by pressure‚ ligature and other conventional procedures is ineffective or impractical․ SURGIFLO Hemostatic Matrix ‚ mixed with with sterile saline or thrombin solution‚ is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical․ SURGIFOAM is a sterile‚ water-insoluble‚ malleable‚ porcine gelatin absorbable sponge or powder intended for hemostatic use by applying to a bleeding surface․ When used in appropriate amounts‚ SURGIFOAM is absorbed completely within 4 to 6 weeks․ Safe and effective use of SURGIFOAM Sponge has been reported in a published neurologic retrospective study involving 1700 cases in Europe․ Safe and effective use in neurosurgery has not been proven through randomized‚ controlled clinical studies in the United States․ SURGIFOAM should be removed from the site of application when used in‚ around‚ or in proximity to foramina in bone‚ areas of bony confine‚ the spinal cord‚ and/or the optic nerve and chiasm․ The safety and effectiveness of SURGIFOAM for use in ophthalmic procedures have not been established․ SURGIFOAM Sponge‚ used dry or saturated with sterile sodium chloride solution‚ is indicated for surgical procedures (except ophthalmic) for hemostasis‚ when control of capillary‚ venous and arteriolar bleeding by pressure‚ ligature and other conventional procedures is ineffective or impractical․
Contraindications
SURGIFOAM is contraindicated in patients with known hypersensitivity to porcine-derived products․ SURGIFOAM should not be used in ophthalmic procedures as the safety and effectiveness of SURGIFOAM for use in ophthalmic procedures have not been established․ SURGIFOAM should be removed from the site of application when used in‚ around‚ or in proximity to foramina in bone‚ areas of bony confine‚ the spinal cord‚ and/or the optic nerve and chiasm․ SURGIFOAM Sponge‚ used dry or saturated with sterile sodium chloride solution‚ is indicated for surgical procedures (except ophthalmic) for hemostasis‚ when control of capillary‚ venous and arteriolar bleeding by pressure‚ ligature and other conventional procedures is ineffective or impractical․ SURGIFOAM Absorbable Hemostatic Gelatin Sponges‚ USP‚ are available in the following size⁚ Please note that all SURGIFOAM Absorbable Gelatin Sponges may not be approved for use in countries outside of the United States and Canada․ SURGIFOAM Powder‚ saturated with sterile sodium chloride solution‚ is indicated for surgical procedures (except ophthalmic) for hemostasis‚ when control of capillary‚ venous and arteriolar bleeding by pressure‚ ligature and other conventional procedures is ineffective or impractical․ SURGIFLO Hemostatic Matrix ‚ mixed with with sterile saline or thrombin solution‚ is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical․ SURGIFOAM is a sterile‚ water-insoluble‚ malleable‚ porcine gelatin absorbable sponge or powder intended for hemostatic use by applying to a bleeding surface․ When used in appropriate amounts‚ SURGIFOAM is absorbed completely within 4 to 6 weeks․ Safe and effective use of SURGIFOAM Sponge has been reported in a published neurologic retrospective study involving 1700 cases in Europe․ Safe and effective use in neurosurgery has not been proven through randomized‚ controlled clinical studies in the United States․
Preparation and Application
SURGIFOAM is a sterile‚ water-insoluble‚ malleable‚ porcine gelatin absorbable sponge or powder intended for hemostatic use by applying to a bleeding surface․ SURGIFOAM Sponge‚ used dry or saturated with sterile sodium chloride solution‚ is indicated for surgical procedures (except ophthalmic) for hemostasis‚ when control of capillary‚ venous and arteriolar bleeding by pressure‚ ligature and other conventional procedures is ineffective or impractical․ SURGIFOAM Sponge‚ used dry or saturated with sterile sodium chloride solution‚ is indicated for surgical procedures (except ophthalmic) for hemostasis‚ when control of capillary‚ venous and arteriolar bleeding by pressure‚ ligature and other conventional procedures is ineffective or impractical․ SURGIFOAM Absorbable Hemostatic Gelatin Sponges‚ USP‚ are available in the following size⁚ Please note that all SURGIFOAM Absorbable Gelatin Sponges may not be approved for use in countries outside of the United States and Canada․ SURGIFOAM Powder‚ saturated with sterile sodium chloride solution‚ is indicated for surgical procedures (except ophthalmic) for hemostasis‚ when control of capillary‚ venous and arteriolar bleeding by pressure‚ ligature and other conventional procedures is ineffective or impractical․ SURGIFLO Hemostatic Matrix ‚ mixed with with sterile saline or thrombin solution‚ is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical․ SURGIFOAM is a sterile‚ water-insoluble‚ malleable‚ porcine gelatin absorbable sponge or powder intended for hemostatic use by applying to a bleeding surface․ When used in appropriate amounts‚ SURGIFOAM is absorbed completely within 4 to 6 weeks․ Safe and effective use of SURGIFOAM Sponge has been reported in a published neurologic retrospective study involving 1700 cases in Europe․ Safe and effective use in neurosurgery has not been proven through randomized‚ controlled clinical studies in the United States․
Dosage and Administration
SURGIFOAM is a sterile‚ water-insoluble‚ malleable‚ porcine gelatin absorbable sponge or powder intended for hemostatic use by applying to a bleeding surface․ SURGIFOAM Sponge‚ used dry or saturated with sterile sodium chloride solution‚ is indicated for surgical procedures (except ophthalmic) for hemostasis‚ when control of capillary‚ venous and arteriolar bleeding by pressure‚ ligature and other conventional procedures is ineffective or impractical․ SURGIFOAM‚ used dry or saturated with sterile sodium chloride solution‚ is indicated for surgical procedures (except ophthalmic) for hemostasis‚ when control of capillary‚ venous and arteriolar bleeding by pressure‚ ligature and other conventional procedures is ineffective or impractical․ SURGIFOAM Absorbable Hemostatic Gelatin Sponges‚ USP‚ are available in the following size⁚ Please note that all SURGIFOAM Absorbable Gelatin Sponges may not be approved for use in countries outside of the United States and Canada․ SURGIFOAM Powder‚ saturated with sterile sodium chloride solution‚ is indicated for surgical procedures (except ophthalmic) for hemostasis‚ when control of capillary‚ venous and arteriolar bleeding by pressure‚ ligature and other conventional procedures is ineffective or impractical․ SURGIFLO Hemostatic Matrix ‚ mixed with with sterile saline or thrombin solution‚ is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical․ SURGIFOAM is a sterile‚ water-insoluble‚ malleable‚ porcine gelatin absorbable sponge or powder intended for hemostatic use by applying to a bleeding surface․ When used in appropriate amounts‚ SURGIFOAM is absorbed completely within 4 to 6 weeks․ Safe and effective use of SURGIFOAM Sponge has been reported in a published neurologic retrospective study involving 1700 cases in Europe․ Safe and effective use in neurosurgery has not been proven through randomized‚ controlled clinical studies in the United States․
Precautions
SURGIFOAM is a sterile‚ water-insoluble‚ malleable‚ porcine gelatin absorbable sponge or powder intended for hemostatic use by applying to a bleeding surface․ The sponge is off-white and porous in appearance․ SURGIFOAM is absorbed completely within 4 to 6 weeks when used in appropriate amounts․ When applied to bleeding mucosal regions‚ it liquefies within 2 to 5 days․ SURGIFOAM should be removed from the site of application when used in‚ around‚ or in proximity to foramina in bone‚ areas of bony confine‚ the spinal cord‚ and/or the optic nerve and chiasm․ The safety and effectiveness of SURGIFOAM for use in ophthalmic procedures have not been established․ SURGIFOAM is a sterile‚ water-insoluble‚ malleable‚ porcine gelatin absorbable sponge or powder intended for hemostatic use by applying to a bleeding surface․ SURGIFOAM Sponge‚ used dry or saturated with sterile sodium chloride solution‚ is indicated for surgical procedures (except ophthalmic) for hemostasis‚ when control of capillary‚ venous and arteriolar bleeding by pressure‚ ligature and other conventional procedures is ineffective or impractical․ SURGIFOAM‚ used dry or saturated with sterile sodium chloride solution‚ is indicated for surgical procedures (except ophthalmic) for hemostasis‚ when control of capillary‚ venous and arteriolar bleeding by pressure‚ ligature and other conventional procedures is ineffective or impractical․ SURGIFOAM Absorbable Hemostatic Gelatin Sponges‚ USP‚ are available in the following size⁚ Please note that all SURGIFOAM Absorbable Gelatin Sponges may not be approved for use in countries outside of the United States and Canada․ SURGIFOAM Powder‚ saturated with sterile sodium chloride solution‚ is indicated for surgical procedures (except ophthalmic) for hemostasis‚ when control of capillary‚ venous and arteriolar bleeding by pressure‚ ligature and other conventional procedures is ineffective or impractical․ SURGIFLO Hemostatic Matrix ‚ mixed with with sterile saline or thrombin solution‚ is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical․
Adverse Reactions
SURGIFOAM is a sterile‚ water-insoluble‚ malleable‚ porcine gelatin absorbable sponge or powder intended for hemostatic use by applying to a bleeding surface․ The sponge is off-white and porous in appearance․ SURGIFOAM is absorbed completely within 4 to 6 weeks when used in appropriate amounts․ When applied to bleeding mucosal regions‚ it liquefies within 2 to 5 days․ SURGIFOAM should be removed from the site of application when used in‚ around‚ or in proximity to foramina in bone‚ areas of bony confine‚ the spinal cord‚ and/or the optic nerve and chiasm․ The safety and effectiveness of SURGIFOAM for use in ophthalmic procedures have not been established․ SURGIFOAM is a sterile‚ water-insoluble‚ malleable‚ porcine gelatin absorbable sponge or powder intended for hemostatic use by applying to a bleeding surface․ SURGIFOAM Sponge‚ used dry or saturated with sterile sodium chloride solution‚ is indicated for surgical procedures (except ophthalmic) for hemostasis‚ when control of capillary‚ venous and arteriolar bleeding by pressure‚ ligature and other conventional procedures is ineffective or impractical․ SURGIFOAM‚ used dry or saturated with sterile sodium chloride solution‚ is indicated for surgical procedures (except ophthalmic) for hemostasis‚ when control of capillary‚ venous and arteriolar bleeding by pressure‚ ligature and other conventional procedures is ineffective or impractical․ SURGIFOAM Absorbable Hemostatic Gelatin Sponges‚ USP‚ are available in the following size⁚ Please note that all SURGIFOAM Absorbable Gelatin Sponges may not be approved for use in countries outside of the United States and Canada․ SURGIFOAM Powder‚ saturated with sterile sodium chloride solution‚ is indicated for surgical procedures (except ophthalmic) for hemostasis‚ when control of capillary‚ venous and arteriolar bleeding by pressure‚ ligature and other conventional procedures is ineffective or impractical․ SURGIFLO Hemostatic Matrix ‚ mixed with with sterile saline or thrombin solution‚ is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical․
