Product Pictures

Absorbable Hemostat

(Gelatin Powder Hemostat)



PAHACEL® Gelatin Hemostat is an absorbable gelatin powder for hemostatic use on bleeding surfaces. PAHACEL® Gelatin Hemostat is beige in appearance and a gamma sterilized powder.

Absorbable Hemostat (Gelatin Powder Hemostat) having properties of:

Indications

PAHACEL® Gelatin Hemostat is used in surgical procedures to assist in the ceasing and control of capillary, venous and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective.

Contraindications

Do not use PAHACEL® Gelatin Hemostat in closure of skin incisions because it may interfere with the healing of skin edges. This interference is due to mechanical interposition of gelatin and is not secondary to intrinsic interference with wound healing. Do not use PAHACEL® Gelatin Hemostat in intravascular compartments because of the risk of embolization. Do not use PAHACEL® Gelatin Hemostat in patients with known allergies to gelatin.

Warnings

PAHACEL® Gelatin Hemostat is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis.

PAHACEL® Gelatin Hemostat should not be used in the presence of infection. PAHACEL® Gelatin Hemostat should be used with caution in contaminated areas of the body. If signs of infection or abscess develop where PAHACEL® Gelatin Hemostat has been positioned, reoperation may be necessary in order to remove the infected material and allow drainage.

PAHACEL® Gelatin Hemostat should not be used in instances of pumping arterial hemorrhage. It should not be used where blood or other fluids have pooled or in cases where the point of hemorrhage is submerged. PAHACEL® Gelatin Hemostat will not act as a tampon or plug in a bleeding site, nor will it close off an area of blood collecting behind a tampon.

PAHACEL® Gelatin Hemostat should be removed if possible once hemostasis has been achieved because of the possibility of dislodgment of the device or compression of other nearby anatomic structures.

PAHACEL® Gelatin Hemostat 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. Care should be exercised to avoid overpacking. PAHACEL® Gelatin Hemostat may swell creating the potential for nerve damage.

The safety and effectiveness of PAHACEL® Gelatin Hemostat for use in ophthalmic and urological procedures has not been established.

PAHACEL® Gelatin Hemostat should not be used for controlling post-partum intrauterine bleeding or menorrhagia.

The safety and effectiveness of PAHACEL® Gelatin Hemostat has not been established in children and pregnant women.

Precautions

PAHACEL® Gelatin Hemostat is supplied as a sterile product and cannot be resterilized.

While packing a cavity for hemostasis is sometimes surgically indicated, PAHACEL® Gelatin Hemostat should not be used in this manner unless excess product that is not needed to maintain hemostasis is removed.

Only the required amount of PAHACEL® Gelatin Hemostat needed to achieve hemostasis should be used. Once hemostasis is achieved, any excess PAHACEL® Gelatin Hemostat should be carefully removed.

PAHACEL® Gelatin Hemostat should not be used in conjunction with autologous blood salvage circuits.

PAHACEL® Gelatin Hemostat should not be used in conjunction with methylmethacrylate adhesives.

PAHACEL® Gelatin Hemostat should not be used for the primary treatment of coagulation disorders.

Although, the safety and effectiveness of the combined use of PAHACEL® Gelatin Hemostat with other agents such as topical thrombin, antibiotic solution or antibiotic powder has not been evaluated in controlled clinical trials, if in the physician's judgment, concurrent use of topical thrombin or other agents is medically advisable, the product literature for that agent should be consulted for complete prescribing information.

Classification

PAHACEL® Gelatin Hemostat is classified as Class III according to Medical Device Directives.

Package

PAHACEL® Gelatin Hemostat is packed as 1 gram and 2 grams vials.

Sterility

Pahacel® Absorbable Hemostat (Gelatin Powder Hemostat) issterilized by Gamma irradiation technique.

Product Pictures