Version May 2024
Hemostasis: Topical: Apply dry directly to source of bleeding; remove excess material after ~5 to 10 minutes. If breakthrough bleeding occurs in areas of thin application, additional product may be applied depending on the severity of bleeding (in capillary bleeding, 1 g will usually be sufficient for a 50 cm2 area; thicker coverage will be required for more brisk bleeding).
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Postmarketing:
Hypersensitivity: Anaphylaxis (Woodruff 2014)
Neuromuscular & skeletal: Laryngospasm (transient; with dental use)
Miscellaneous: Granuloma (including colonic serosa, foreign body granuloma) (Doita 2006, McGregor 1986), seroma (subgaleal)
Closure of skin incisions; application to bone surfaces to which prosthetic materials are attached with methylmethacrylate adhesives.
Concerns related to adverse effects:
• Pain/numbness/paralysis: Pain, numbness, or paralysis have been reported if used near a bony or neural space and left inside patient; use minimum amount necessary to achieve hemostasis (FDA, 2004).
Dosage forms specific issues:
• Sponge: Do not use in instances of pumping arterial hemorrhage, where blood or other fluids have pooled, or where the point of hemorrhage is submerged as it may mask an underlying source of bleeding, resulting in hematoma.
Other warnings/precautions:
• Appropriate use: Not for injection, intraocular, or intravascular use. Do not use as a surface dressing except for immediate control of bleeding; use minimum amount necessary to achieve hemostasis. Avoid spillage on nonbleeding surfaces particularly in abdominal or thoracic viscera. Remove as much of agent as possible after hemostasis is achieved. Do not use in conjunction with autologous blood salvage circuits because fragments of MCH may pass through filters of blood scavenging systems; avoid reintroduction of blood from operative sites treated with MCH. Not intended to treat systemic coagulation disorders. Do not reuse, reprocess, resterilize, or repackage because doing so may lead to device failure or create a risk of contamination of the device and/or cause patient infection or cross infection.
• Bovine origin: Contains bovine serum protein; increases in anti-BSA titer have been observed. Use is not recommended in patients sensitive to bovine derived collagen.
• Infection: Use in contaminated wounds may enhance infection; do not leave MCH in a contaminated or infected space.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Miscellaneous, External:
Actifoam Collagen Sponge: (10 ea)
Endo Avitene: (1 ea)
Syringe Avitene: (1 g)
Ultrafoam Sponge 2x6.25x7CM: 2 cm x 6.25 cm x 7 cm (1 ea)
Ultrafoam Sponge 8x12.5x1CM: 8 cm x 12.5 cm x 1 cm (1 ea)
Ultrafoam Sponge 8x12.5x3CM: 8 cm x 12.5 cm x 3 cm (1 ea)
Ultrafoam Sponge 8x25x1CM: 8 cm x 25 cm x 1 cm (1 ea)
Ultrafoam Sponge 8x6.25x1CM: 8 cm x 6.25 cm x 1 cm (1 ea)
Pad, External:
Avitene: (1 ea)
Powder, External:
Avitene Flour: (6 ea, 1 g, 5 g)
No
For topical use only in in surgical procedures; not for injection, intraocular, or intravascular use. MCH will adhere to wet gloves, instruments, or tissue surfaces; use dry, smooth forceps or a pre-loaded applicator device to apply. Surfaces to be treated should be compressed with dry sponges immediately prior to application. Administer dry (avoiding spillage on nonbleeding surfaces) and then apply pressure over the application site with a dry sponge until hemostasis results (1 minute may suffice for capillary bleeding, but >3 to 5 minutes may be required for brisk bleeding or high pressure leaks in major artery suture holes). For control of oozing from cancellous bone, firmly pack into the spongy bone surface. Avoid packing tightly in cavities, especially within the bony enclosure of the CNS or within other relatively rigid cavities where swelling may interfere with normal function or possibly cause necrosis. After ~5 to10 minutes, remove excess material with blunt forceps and facilitate by wetting with sterile NS and irrigation.
Hemostasis: Adjunct to hemostasis in surgical procedures when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Avitene may be confused with Ativan
Over 100 reports of paralysis or other neural deficits have been received by the FDA, attributable to collagen hemostat-associated neuronal impingement; see Warnings/Precautions
None known.
There are no known significant interactions.
Collagen hemostat is an absorbable topical hemostatic agent prepared from purified bovine corium collagen and shredded into fibrils. Physically, microfibrillar collagen hemostat yields a large surface area. Chemically, it is collagen with hydrochloric acid noncovalently bound to some of the available amino groups in the collagen molecules. When in contact with a bleeding surface, collagen hemostat attracts platelets which adhere to its fibrils and undergo the release phenomenon. This triggers aggregation of the platelets into thrombi in the interstices of the fibrous mass, initiating the formation of a physiologic platelet plug.
Onset of hemostasis: 2 to 5 minutes
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