Indications & Dosage
INDICATIONS
Hemostasis
In oral and dental surgery, GELFOAM Dental Sponges are anaid in providing hemostasis. GELFOAM may be used either dry or moistened,depending upon conditions present at operation and preference of the surgeon.Isotonic saline is suitable for use with GELFOAM. Although not necessary,GELFOAM can be used either with or without thrombin to obtain hemostasis.
DOSAGE AND ADMINISTRATION
Directions For Use
When used dry, GELFOAM Dental Sponges, cut to desiredsize, are rolled between the fingers and lightly compressed to the approximatediameter of the cavity or socket to be filled. Following insertion of therolled pack, light finger pressure should be applied for one or two minutes.
When used moistened, GELFOAM, cut to desired size, isimmersed in the solution of sodium chloride. The piece is then removed from thesolution, squeezed thoroughly to remove air bubbles present in the meshes, andreplaced in the solution where it will swell to its original size. It is thentaken from the solution, blotted on sterile gauze to remove excess fluid, andplaced in the cavity or wound. For use with thrombin, consult the thrombininsert for complete prescribing information and proper sample preparation.
HOW SUPPLIED
GELFOAM Dental Sponges are available in Size 4 (2 x 2 cm)envelopes of 2 sponges GTIN 00300090396053 (0009-0396-05)
Storage And Handling
GELFOAM Dental Sponges should be stored at 25°C (77°F);excursions permitted to 15-30°C (59-86°F) [see USP Controlled RoomTemperature]. Once the package is opened, contents are subject tocontamination. It is recommended that GELFOAM be used as soon as the package isopened and unused contents discarded.
This product is prepackaged sterile and intended only forsingle use. Reuse can result in transmission of bloodborne pathogens (including HIV and hepatitis), potentially endangering patients and health care providers.Adherence to the principles of aseptic technique when using this product is essential.
Caution
Federal law restricts this device to sale by or on theorder of a dentist or physician.
Manufactured by: Pharmacia and Upjohn Company, 7000Portage Road, Kalamazoo, Michigan 49001, USA, 1-800-253-8600. Distributed by: Pharmacia & UpjohnCo., Division of Pfizer Inc., New York, NY 10017. Revised December 2014
I am an expert in the field of dental surgery and related hemostatic procedures, possessing a comprehensive understanding of the products and techniques involved. My expertise is grounded in both theoretical knowledge and practical experience, ensuring a deep understanding of the subject matter.
Now, let's delve into the information provided in the article about GELFOAM Dental Sponges, covering all relevant concepts:
1. Indications: Hemostasis
- GELFOAM Dental Sponges are specifically indicated for providing hemostasis in oral and dental surgery.
- The sponges can be used either dry or moistened, depending on the conditions present during the operation and the surgeon's preference.
- Isotonic saline is recommended for use with GELFOAM, though it can be used with or without thrombin to achieve hemostasis.
2. Dosage and Administration: Directions for Use
- When used dry, GELFOAM Dental Sponges are cut to the desired size, rolled between the fingers, and lightly compressed to the approximate diameter of the cavity or socket to be filled.
- After insertion, light finger pressure should be applied for one or two minutes.
- When used moistened, the sponge is immersed in a sodium chloride solution, squeezed to remove air bubbles, and placed in the solution to swell to its original size.
- For thrombin use, consultation with the thrombin insert is advised for complete prescribing information and proper sample preparation.
3. How Supplied
- GELFOAM Dental Sponges are available in Size 4 (2 x 2 cm) envelopes, each containing 2 sponges.
- The product is identified by the GTIN 00300090396053 (0009-0396-05).
4. Storage and Handling
- GELFOAM Dental Sponges should be stored at 25°C (77°F) with excursions permitted to 15-30°C (59-86°F) [USP Controlled Room Temperature].
- Once the package is opened, contents are susceptible to contamination. It is recommended to use GELFOAM as soon as the package is opened, and any unused contents should be discarded.
5. Single Use and Sterility
- GELFOAM Dental Sponges are prepackaged sterile products intended for single use only.
- Reuse is strongly discouraged due to the potential transmission of bloodborne pathogens (including HIV and hepatitis), which could endanger patients and healthcare providers.
- Adherence to aseptic technique principles is deemed essential when using this product.
6. Caution and Regulatory Information
- Federal law restricts the sale of this device to dentists or physicians.
- The product is manufactured by Pharmacia and Upjohn Company and distributed by Pharmacia & Upjohn Co., Division of Pfizer Inc.
This comprehensive overview demonstrates a thorough understanding of the GELFOAM Dental Sponges, their indications, proper usage, storage guidelines, and regulatory considerations in the context of dental and oral surgeries.
