Gelfoam (Absorbable Gelatin)

Type
Product
Manufacturer
Country
Dosage
Qty
Price(USD)
Type: drug type
Product: Gelfoam 4/ box (ON BACKORDER)
Manufacturer: Pfizer
Country: Canada
Dosage: Sponge Size 12.7
Qty: 1
USD $101.99
Type: drug type
Product: Gelfoam 6/ box (ON BACKORDER)
Manufacturer: Pfizer
Country: Canada
Dosage: Sponge Size 100
Qty: 1
USD $231.99

Gelfoam Information

NO PRESCRIPTION REQUIRED FOR GELFOAM. Gelfoam is a medical device, intended for application to bleeding surfaces as a hemostatic. It is a water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified pork Skin Gelatin USP granules and Water for injection, USP and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Gelfoam sterile powder is a fine, dry, heat-sterilized light powder prepared by milling absorbable gelatin sponge. Gelfoam sterile sponge may be cut without fraying. Gelfoam has hemostatic properties. While its mode of action is not fully understood, its effect appears to be more physical than the result of altering the blood clotting mechanism.

When not used in excessive amounts. Gelfoam is absorbed completely, with little tissue reaction. This absorption is dependent on several factors, including the amount used, degree of saturation with blood or other fluids, and the site of use. When placed in soft tissues, Gelfoam is usually absorbed completely in from 4 to 6 weeks, without inducing excessive scar tissue. When applied to bleeding nasal, rectal or vaginal mucosa, it liquefies within 2 to 5 days.

Hemostasis: Gelfoam sterile sponge, used dry or saturated with sterile sodium chloride solution, and Gelfoam sterile powder, saturated with sterile sodium chloride solution are indicated in surgical procedures as a hemostatic device, when control of capillary, venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures is either ineffective or impractical. However, in case of brisk arterial bleeding, the pressure of the flow may prevent the sponge from remaining securely anchored, and bleeding is likely to continue. Contra-Indications: Gelfoam should not be used in closure of skin incisions because it may interfere with healing of the skin edges. This is due to mechanical interposition of gelatin and is not secondary to intrinsic interference with wound healing. Gelfoam should not be placed in intravascular compartments, because of the risk of embolization. Sterile technique should always be used. The minimum amount of Gelfoam should be applied to the bleeding site (see Directions For Use) with pressure until hemostasis is observed. Opened packages or jars of unused Gelfoam should always be discarded. Directions for Use: Sponge: Always use sterile technique when handling Gelfoam sterile sponge. Gelfoam should be cut to the minimum size required to attain hemostasis. Gelfoam may be applied dry or saturated with a physiologic saline solution. When applied dry, Gelfoam should be manually compressed before application to the bleeding site. When used with saline, Gelfoam should be soaked in the solution, then withdrawn, squeezed between gloved fingers to expel air bubbles present in the interstices, replaced in saline, and kept there until needed. Gelfoam should immediately return to its original size and shape when returned to the solution. If it does not swell, it should be removed and kneaded vigorously until all air is expelled and it does expand to its original shape when dropped into the solution. Gelfoam can be used wet or blotted to dampness on gauze before application to the bleeding site. Gelfoam should be applied to the bleeding surface and held in place with moderate pressure until hemostasis is attained. It is not necessary to apply suction to Gelfoam, since Gelfoam will draw up blood into its interstices by capillary action. Usually, the first application of Gelfoam will control bleeding, but if not, additional applications may be made, using fresh pieces of Gelfoam. Directions for Use: Powder: Gelfoam sterile powder can be saturated with sterile, isotonic sodium chloride solution (sterile saline), before use as an adjunct to hemostatis. The jar of Gelfoam sterile powder should be opened and the contents (1 g) poured carefully into a sterile beaker, avoiding contamination. Using sterile technique, a putty-like paste is prepared by adding a total of approximately 3 to 4 mL of sterile saline to the Gelfoam. Dispersion of the powder can be avoided by initially compressing it with the gloved fingers into the bottom of the beaker and then kneading it into the desired consistency. The resulting doughy paste may be smeared or pressed against the bleeding surface to control bleeding. When bleeding stops the excess should be removed. Use only the minimum amount of Gelfoam, necessary to produce hemostasis. The Gelfoam may be left in place at the bleeding site, when necessary. Since Gelfoam causes little more cellular reaction than does the blood clot, the wound may be closed over it. Gelfoam may be left in place when applied to mucosal surfaces until it liquefies.

Gelfoam Side Effects

There have been reports of fever associated with the use of Gelfoam, without demonstrable infection. Gelfoam may serve as a nidus for infection and abscess formation, and has been reported to potentiate bacterial growth. Giant-cell granuloma has been reported at the implantation site of absorbable gelatin product in the brain, as has compression of the brain and spinal cord resulting from the accumulation of sterile fluid. Foreign body reactions, "encapsulation" of fluid and hematoma have also been reported. When Gelfoam was used in laminectomy operations, multiple neurologic events were reported, including but not limited to cauda equina syndrome, spinal stenosis, meningitis, arachnoiditis, headaches, paresthesias, pain, bladder and bowel dysfunction, and impotence. Excessive fibrosis and prolonged fixation of a tendon have been reported when absorbable gelatin products were used in severed tendon repair. Toxic shock syndrome has been reported in association with the use of Gelfoam in nasal surgery. Fever, failure of absorption, and hearing loss have been reported in association with the use of Gelfoam during tympanoplasty. Adverse Reactions Reported From Unapproved Uses: Gelfoam is not recommended for use other than as an adjunct for hemostasis. While some adverse medical events following the unapproved use of Gelfoam have been reported to Pharmacia & Upjohn (see Adverse Effects), other hazards associated with such use may not have been reported. When Gelfoam has been used during intravascular catheterization for the purpose of producing vessel occlusion, the following adverse events have been reported: fever, duodenal and pancreatic infarct, embolization of lower extremity vessels, pulmonary embolization, splenic abscess, necrosis of specific anatomic areas, asterixis and death. These adverse medical events have been associated with the use of Gelfoam for repair of dural defects encountered during laminectomy and craniotomy operations: fever, infection, leg paresthesias, neck and back pain, bladder and bowel incontinence, cauda equina syndrome, neurogenic bladder, impotence, and paresis.

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Prescriptions Dispensed from Canada are Dispensed by: Candrug Pharmacy, ID#18985 604-543-8711. Pharmacy Manager: Sanaa Abdelati. This pharmacy is duly licensed in the province of British Columbia, Canada by the College of Pharmacists of BC. If you have any questions or concerns you can contact the college at: 200-1765 West 8th Ave Vancouver, BC V6J 5C6 Canada. All prices are in US dollars.
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