Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING RECOTHROM Thrombin topical (Recombinant), is supplied in single-use, preservative-free vials in the following packages: NDC 0338-0322-01 A 5,000-unit vial of RECOTHROM with a 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride, USP), a sterile needle-free vial access device, and a 5-mL sterile empty transfer syringe. NDC 0338-0326-01 A 20,000-unit vial of RECOTHROM with a 20-mL vial of diluent (containing sterile 0.9% sodium chloride, USP), 2 sterile needle-free vial access devices, and a 20-mL sterile empty transfer syringe. NDC 0338-0330-01 The 20,000-unit RECOTHROM kit co-packaged with RECOTHROM Spray Applicator Kit. No RECOTHROM kit components contain latex. Store RECOTHROM sterile powder vials at 2°C to 25°C (36°F to 77°F). Do not freeze. Reconstituted solutions of RECOTHROM prepared with sterile 0.9% sodium chloride, USP, may be stored for up to 24 hours at 2°C to 25°C (36°F to 77°F). Discard reconstituted solution after 24 hours.; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Carton Label PS 5,000 units NDC: 0338-0322-01 FOR TOPICAL USE ONLY - DO NOT INJECT Baxter Logo RECOTHROM THROMBIN TOPICAL (RECOMBINANT) Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA US License No. 0140 Made in Italy FPO FPO 5,000 units Rx only CONTENTS: • One single-use vial containing 5,000 International Units of sterile Thrombin topical (Recombinant) • One 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride injection, USP) • One sterile needle-free transfer device • One sterile 5-mL empty syringe for transfer PS 5,000 units NDC: 0338-0322-01 FOR TOPICAL USE ONLY - DO NOT INJECT Baxter Logo RECOTHROM THROMBIN TOPICAL (RECOMBINANT) Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA US License No. 0140 Baxter and Recothrom are registered trademarks of Baxter International Inc. Made in Italy Rx only CONTENTS: • One single-use vial containing 5,000 International Units of sterile Thrombin topical (Recombinant) • One 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride injection, USP) • One sterile needle-free transfer device • One sterile 5-mL empty syringe for transfer FPO 5,000 UNITS Rx only Store at 2-25°C (36-77°F). Do not freeze. See package insert Full Prescribing Information. Baxter Logo 07-01-00-1475 5,000 units NDC: 0338-0322-01 FOR TOPICAL USE ONLY - DO NOT INJECT Baxter Logo RECOTHROM THROMBIN TOPICAL (RECOMBINANT) Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA US License No. 0140 Made in Italy Rx only Store at 2-25°C (36-77°F). Do not freeze. See package insert Full Prescribing Information. No components contain latex. No preservative. Carton Label 20,000 units NDC: 0338-0326-01 FOR TOPICAL USE ONLY - DO NOT INJECT Baxter Logo RECOTHROM THROMBIN TOPICAL (RECOMBINANT) Rx only Store at 2-25°C (36-77°F). Do not freeze. See package insert Full Prescribing Information. Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA US License No. 0140 Made in Italy FPO FPO 20,000 units NDC: 0338-0326-01 Rx only Store at 2-25°C (36-77°F). Do not freeze. See package insert Full Prescribing Information. CONTENTS: • One single-use vial containing 20,000 International Units of sterile Thrombin topical (Recombinant) • One vial diluent (containing 20-mL sterile 0.9% sodium chloride injection, USP) • Two sterile needle-free transfer devices • One sterile 20-mL empty syringe for transfer 20,000 units NDC: 0338-0326-01 FOR TOPICAL USE ONLY - DO NOT INJECT Baxter Logo RECOTHROM THROMBIN TOPICAL (RECOMBINANT) Rx only Store at 2-25°C (36-77°F). Do not freeze. See package insert Full Prescribing Information. CONTENTS: • One single-use vial containing 20,000 International Units of sterile Thrombin topical (Recombinant) • One vial diluent (containing 20-mL sterile 0.9% sodium chloride injection, USP) • Two sterile needle-free transfer devices • One sterile 20-mL empty syringe for transfer FPO 20,000 units NDC: 0338-0326-01 FOR TOPICAL USE ONLY - DO NOT INJECT Baxter Logo RECOTHROM THROMBIN TOPICAL (RECOMBINANT) Rx only Store at 2-25°C (36-77°F). Do not freeze. See package insert Full Prescribing Information. 07-01-00-1478 20,000 units NDC: 0338-0326-01 FOR TOPICAL USE ONLY - DO NOT INJECT Baxter Logo RECOTHROM THROMBIN TOPICAL (RECOMBINANT) Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA US License No. 0140 Made in Italy Rx only Store at 2-25°C (36-77°F). Do not freeze. See package insert Full Prescribing Information. No Components contain latex. No preservative. Baxter and Recothrom are registered trademarks of Baxter International Inc. Carton Label 20,000 units NDC: 0338-0330-01 FOR TOPICAL USE ONLY - DO NOT INJECT RECOTHROM THROMBIN TOPICAL (RECOMBINANT) 20,000 units WITH SPRAY APPLICATOR KIT Rx only Store at 2-25°C (36-77°F). Do not freeze. See package insert Full Prescribing Information. No components contain latex. No preservative. RECOTHROM CONTENTS: • One single-use vial containing 20,000 International Units of sterile Thrombin topical (Recombinant) • One vial diluent (containing 20-mL sterile 0.9% sodium chloride injection, USP) • Two sterile needle-free transfer devices • One sterile 20-mL empty syringe for transfer SPRAY APPLICATOR CONTENTS: • One spray pump • One spray bottle • One syringe spray tip • One 20-mL syringe • One 30-mL bowl • Two blank labels • Instructions for use Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA US License No. 0140 Made in Italy Baxter Logo Baxter and Recothrom are registered trademarks of Baxter International Inc. 20,000 units NDC: 0338-0330-01 FOR TOPICAL USE ONLY - DO NOT INJECT RECOTHROM THROMBIN TOPICAL (RECOMBINANT) 20,000 units WITH SPRAY APPLICATOR KIT Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA US License No. 0140 Made in Italy Baxter Logo 07-03-00-1214 FPO 20,000 units NDC: 0338-0330-01 FOR TOPICAL USE ONLY - DO NOT INJECT RECOTHROM THROMBIN TOPICAL (RECOMBINANT) 20,000 units WITH SPRAY APPLICATOR KIT Rx only Store at 2-25°C (36-77°F). Do not freeze. See package insert Full Prescribing Information. No components contain latex. No preservative. 07-03-00-1214 20,000 units NDC: 0338-0330-01 FOR TOPICAL USE ONLY - DO NOT INJECT RECOTHROM THROMBIN TOPICAL (RECOMBINANT) 20,000 units WITH SPRAY APPLICATOR KIT Rx only Store at 2-25°C (36-77°F). Do not freeze. See package insert Full Prescribing Information. No components contain latex. No preservative. RECOTHROM CONTENTS: • One single-use vial containing 20,000 International Units of sterile Thrombin topical (Recombinant) • One vial diluent (containing 20-mL sterile 0.9% sodium chloride injection, USP) • Two sterile needle-free transfer devices • One sterile 20-mL empty syringe for transfer SPRAY APPLICATOR CONTENTS: • One spray pump • One spray bottle • One syringe spray tip • One 20-mL syringe • One 30-mL bowl • Two blank labels • Instructions for use FPO FPO 20,000 units NDC: 0338-0330-01 Baxter Logo RECOTHROM THROMBIN TOPICAL (RECOMBINANT) 20,000 units WITH SPRAY APPLICATOR KIT FOR TOPICAL USE ONLY - DO NOT INJECT Rx only Store at 2-25°C (36-77°F). Do not freeze. See package insert Full Prescribing Information. No components contain latex. No preservative. RECOTHROM CONTENTS: • One single-use vial containing 20,000 International Units of sterile Thrombin topical (Recombinant) • One vial diluent (containing 20-mL sterile 0.9% sodium chloride injection, USP) • Two sterile needle-free transfer devices • One sterile 20-mL empty syringe for transfer SPRAY APPLICATOR CONTENTS: • One spray pump • One spray bottle • One syringe spray tip • One 20-mL syringe • One 30-mL bowl • Two blank labels • Instructions for use Recothrom Representative Carton Label 0338-0322-01 1 of 3 Recothrom Representative Carton Label 0338-0322-01 2 of 3 Recothrom Representative Carton Label 0338-0322-01 3 of 3 Recothrom Representative Carton Label 0338-0326-01 1 of 3 Recothrom Representative Carton Label 0338-0326-01 2 of 3 Recothrom Representative Carton Label 0338-0326-01 3 of 3 Recothrom Representative Carton Label 0338-0330-01 1 of 2 Recothrom Representative Carton Label 0338-0330-01 2 of 2
- 16 HOW SUPPLIED/STORAGE AND HANDLING RECOTHROM Thrombin topical (Recombinant), is supplied in single-use, preservative-free vials in the following packages: NDC 0338-0322-01 A 5,000-unit vial of RECOTHROM with a 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride, USP), a sterile needle-free vial access device, and a 5-mL sterile empty transfer syringe. NDC 0338-0326-01 A 20,000-unit vial of RECOTHROM with a 20-mL vial of diluent (containing sterile 0.9% sodium chloride, USP), 2 sterile needle-free vial access devices, and a 20-mL sterile empty transfer syringe. NDC 0338-0330-01 The 20,000-unit RECOTHROM kit co-packaged with RECOTHROM Spray Applicator Kit. No RECOTHROM kit components contain latex. Store RECOTHROM sterile powder vials at 2°C to 25°C (36°F to 77°F). Do not freeze. Reconstituted solutions of RECOTHROM prepared with sterile 0.9% sodium chloride, USP, may be stored for up to 24 hours at 2°C to 25°C (36°F to 77°F). Discard reconstituted solution after 24 hours.
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Carton Label PS 5,000 units NDC: 0338-0322-01 FOR TOPICAL USE ONLY - DO NOT INJECT Baxter Logo RECOTHROM THROMBIN TOPICAL (RECOMBINANT) Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA US License No. 0140 Made in Italy FPO FPO 5,000 units Rx only CONTENTS: • One single-use vial containing 5,000 International Units of sterile Thrombin topical (Recombinant) • One 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride injection, USP) • One sterile needle-free transfer device • One sterile 5-mL empty syringe for transfer PS 5,000 units NDC: 0338-0322-01 FOR TOPICAL USE ONLY - DO NOT INJECT Baxter Logo RECOTHROM THROMBIN TOPICAL (RECOMBINANT) Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA US License No. 0140 Baxter and Recothrom are registered trademarks of Baxter International Inc. Made in Italy Rx only CONTENTS: • One single-use vial containing 5,000 International Units of sterile Thrombin topical (Recombinant) • One 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride injection, USP) • One sterile needle-free transfer device • One sterile 5-mL empty syringe for transfer FPO 5,000 UNITS Rx only Store at 2-25°C (36-77°F). Do not freeze. See package insert Full Prescribing Information. Baxter Logo 07-01-00-1475 5,000 units NDC: 0338-0322-01 FOR TOPICAL USE ONLY - DO NOT INJECT Baxter Logo RECOTHROM THROMBIN TOPICAL (RECOMBINANT) Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA US License No. 0140 Made in Italy Rx only Store at 2-25°C (36-77°F). Do not freeze. See package insert Full Prescribing Information. No components contain latex. No preservative. Carton Label 20,000 units NDC: 0338-0326-01 FOR TOPICAL USE ONLY - DO NOT INJECT Baxter Logo RECOTHROM THROMBIN TOPICAL (RECOMBINANT) Rx only Store at 2-25°C (36-77°F). Do not freeze. See package insert Full Prescribing Information. Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA US License No. 0140 Made in Italy FPO FPO 20,000 units NDC: 0338-0326-01 Rx only Store at 2-25°C (36-77°F). Do not freeze. See package insert Full Prescribing Information. CONTENTS: • One single-use vial containing 20,000 International Units of sterile Thrombin topical (Recombinant) • One vial diluent (containing 20-mL sterile 0.9% sodium chloride injection, USP) • Two sterile needle-free transfer devices • One sterile 20-mL empty syringe for transfer 20,000 units NDC: 0338-0326-01 FOR TOPICAL USE ONLY - DO NOT INJECT Baxter Logo RECOTHROM THROMBIN TOPICAL (RECOMBINANT) Rx only Store at 2-25°C (36-77°F). Do not freeze. See package insert Full Prescribing Information. CONTENTS: • One single-use vial containing 20,000 International Units of sterile Thrombin topical (Recombinant) • One vial diluent (containing 20-mL sterile 0.9% sodium chloride injection, USP) • Two sterile needle-free transfer devices • One sterile 20-mL empty syringe for transfer FPO 20,000 units NDC: 0338-0326-01 FOR TOPICAL USE ONLY - DO NOT INJECT Baxter Logo RECOTHROM THROMBIN TOPICAL (RECOMBINANT) Rx only Store at 2-25°C (36-77°F). Do not freeze. See package insert Full Prescribing Information. 07-01-00-1478 20,000 units NDC: 0338-0326-01 FOR TOPICAL USE ONLY - DO NOT INJECT Baxter Logo RECOTHROM THROMBIN TOPICAL (RECOMBINANT) Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA US License No. 0140 Made in Italy Rx only Store at 2-25°C (36-77°F). Do not freeze. See package insert Full Prescribing Information. No Components contain latex. No preservative. Baxter and Recothrom are registered trademarks of Baxter International Inc. Carton Label 20,000 units NDC: 0338-0330-01 FOR TOPICAL USE ONLY - DO NOT INJECT RECOTHROM THROMBIN TOPICAL (RECOMBINANT) 20,000 units WITH SPRAY APPLICATOR KIT Rx only Store at 2-25°C (36-77°F). Do not freeze. See package insert Full Prescribing Information. No components contain latex. No preservative. RECOTHROM CONTENTS: • One single-use vial containing 20,000 International Units of sterile Thrombin topical (Recombinant) • One vial diluent (containing 20-mL sterile 0.9% sodium chloride injection, USP) • Two sterile needle-free transfer devices • One sterile 20-mL empty syringe for transfer SPRAY APPLICATOR CONTENTS: • One spray pump • One spray bottle • One syringe spray tip • One 20-mL syringe • One 30-mL bowl • Two blank labels • Instructions for use Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA US License No. 0140 Made in Italy Baxter Logo Baxter and Recothrom are registered trademarks of Baxter International Inc. 20,000 units NDC: 0338-0330-01 FOR TOPICAL USE ONLY - DO NOT INJECT RECOTHROM THROMBIN TOPICAL (RECOMBINANT) 20,000 units WITH SPRAY APPLICATOR KIT Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA US License No. 0140 Made in Italy Baxter Logo 07-03-00-1214 FPO 20,000 units NDC: 0338-0330-01 FOR TOPICAL USE ONLY - DO NOT INJECT RECOTHROM THROMBIN TOPICAL (RECOMBINANT) 20,000 units WITH SPRAY APPLICATOR KIT Rx only Store at 2-25°C (36-77°F). Do not freeze. See package insert Full Prescribing Information. No components contain latex. No preservative. 07-03-00-1214 20,000 units NDC: 0338-0330-01 FOR TOPICAL USE ONLY - DO NOT INJECT RECOTHROM THROMBIN TOPICAL (RECOMBINANT) 20,000 units WITH SPRAY APPLICATOR KIT Rx only Store at 2-25°C (36-77°F). Do not freeze. See package insert Full Prescribing Information. No components contain latex. No preservative. RECOTHROM CONTENTS: • One single-use vial containing 20,000 International Units of sterile Thrombin topical (Recombinant) • One vial diluent (containing 20-mL sterile 0.9% sodium chloride injection, USP) • Two sterile needle-free transfer devices • One sterile 20-mL empty syringe for transfer SPRAY APPLICATOR CONTENTS: • One spray pump • One spray bottle • One syringe spray tip • One 20-mL syringe • One 30-mL bowl • Two blank labels • Instructions for use FPO FPO 20,000 units NDC: 0338-0330-01 Baxter Logo RECOTHROM THROMBIN TOPICAL (RECOMBINANT) 20,000 units WITH SPRAY APPLICATOR KIT FOR TOPICAL USE ONLY - DO NOT INJECT Rx only Store at 2-25°C (36-77°F). Do not freeze. See package insert Full Prescribing Information. No components contain latex. No preservative. RECOTHROM CONTENTS: • One single-use vial containing 20,000 International Units of sterile Thrombin topical (Recombinant) • One vial diluent (containing 20-mL sterile 0.9% sodium chloride injection, USP) • Two sterile needle-free transfer devices • One sterile 20-mL empty syringe for transfer SPRAY APPLICATOR CONTENTS: • One spray pump • One spray bottle • One syringe spray tip • One 20-mL syringe • One 30-mL bowl • Two blank labels • Instructions for use Recothrom Representative Carton Label 0338-0322-01 1 of 3 Recothrom Representative Carton Label 0338-0322-01 2 of 3 Recothrom Representative Carton Label 0338-0322-01 3 of 3 Recothrom Representative Carton Label 0338-0326-01 1 of 3 Recothrom Representative Carton Label 0338-0326-01 2 of 3 Recothrom Representative Carton Label 0338-0326-01 3 of 3 Recothrom Representative Carton Label 0338-0330-01 1 of 2 Recothrom Representative Carton Label 0338-0330-01 2 of 2
Overview
RECOTHROM Thrombin topical (Recombinant), is a human coagulation protein produced via recombinant DNA technology from a genetically modified CHO cell line. RECOTHROM is identical in amino acid sequence and structurally similar to naturally occurring human thrombin. RECOTHROM precursor is secreted to culture medium as single chain form that is proteolytically converted to a two-chain active form (using a protein derived from snakes) and is purified by a chromatographic process that yields a product having hemostatic activities similar to native human thrombin. The cell line used to manufacture RECOTHROM has been tested and shown to be free of known infectious agents. The cell culture process used in the manufacture of RECOTHROM employs no additives of human or animal origin. The purification process includes solvent-detergent treatment and nano-filtration steps dedicated to viral clearance. RECOTHROM is provided as a sterile, white to off-white, preservative-free, lyophilized powder in vials for reconstitution with diluent (sterile 0.9% sodium chloride, USP). Reconstitution with the provided diluent, as described [see Dosage and Administration (2.1) ] , yields a solution with a pH of 6.0 containing 1,000 units/mL of recombinant thrombin for topical use. The formulated product is a clear, colorless solution upon reconstitution and contains the following excipients: histidine, mannitol, sucrose, polyethylene glycol 3350, sodium chloride, and calcium chloride dihydrate, USP.
Indications & Usage
RECOTHROM Thrombin topical (Recombinant), is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP. RECOTHROM Thrombin topical (Recombinant), is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. (1) RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP. (1)
Dosage & Administration
For topical use only. DO NOT INJECT. For topical use only. DO NOT INJECT. (2) • Reconstitute RECOTHROM Thrombin topical (Recombinant) powder with sterile 0.9% sodium chloride, USP, yielding a solution containing 1,000 units (international units of potency) per mL. (2.1) • Apply RECOTHROM solution with absorbable gelatin sponge or RECOTHROM Spray Applicator Kit directly to the bleeding site surface. The amount required depends upon the area of tissue to be treated. (2.2) • 5,000-unit RECOTHROM may be used in conjunction with FLOSEAL NT Hemostatic Matrix, 5mL ( 2.2 ) 2.1 Reconstitution of RECOTHROM Thrombin The volume of reconstituted RECOTHROM Thrombin topical (Recombinant) required will vary depending on the size and number of bleeding sites to be treated and the method of application. Inspect the integrity of the RECOTHROM package and contents. Do not use if the packaging or contents have been damaged or opened. Reconstitute the lyophilized powder using the supplied diluent. Use aseptic technique when handling vials and syringes. 5,000-unit RECOTHROM Thrombin topical (Recombinant) Reconstitution Units used herein represent international units of potency determined using a reference standard that has been calibrated against the World Health Organization Second International Standard for Thrombin. 1. Remove flip-off cap from the top of the RECOTHROM vial. 2. Attach the needle-free vial access device (VAD) and snap it into place on the vial by placing the vial on a flat surface and pushing the VAD straight down into the center of the vial stopper. 3. Attach the prefilled diluent syringe to the VAD. 4. Transfer the 5 mL of diluent from the syringe into the RECOTHROM vial. 5. DO NOT reuse the diluent syringe for transfer of the reconstituted product. Remove and discard the diluent syringe. 6. Gently swirl and invert the RECOTHROM vial until the powder is completely dissolved. Avoid excessive agitation. The powder should dissolve in less than one minute at room temperature. RECOTHROM solution should remain in the vial until ready for transfer to a labeled sterile bowl or basin. 7. Withdraw reconstituted RECOTHROM solution into transfer syringe labeled For topical use only, DO NOT INJECT. Transfer RECOTHROM solution into a labeled sterile bowl or basin. 8. RECOTHROM is ready for application. RECOTHROM is for topical use only – DO NOT INJECT. See Application techniques below (2.2). RECOTHROM is for single use only. Discard unused contents. 20,000-unit RECOTHROM Thrombin topical (Recombinant) Reconstitution 1. Remove the flip-off cap from the top of the RECOTHROM vial and the diluent vial. 2. There are two needle-free vial access devices (VADs) provided. Attach one VAD to the RECOTHROM vial and one VAD to the diluent vial. To attach a VAD to a vial, place the vial on a flat surface and push straight down on the VAD into the center of the vial stopper. 3. Attach the empty 20-mL transfer syringe to the VAD on the diluent vial (injection of air into the diluent vial may facilitate withdrawal of the diluent). This syringe will be used twice: 1. To draw up the diluent from the diluent vial to be transferred into the RECOTHROM vial for reconstitution and 2. To draw up the reconstituted RECOTHROM solution. 4. Draw up 20 mL of diluent from the vial into the syringe. 5. Remove the diluent-filled syringe from the diluent vial and attach the syringe to the VAD on the RECOTHROM vial. 6. Transfer the 20 mL of diluent from the syringe into the RECOTHROM vial. 7. Leave the syringe attached and gently swirl and invert the RECOTHROM vial until the powder is completely dissolved. Avoid excessive agitation. The powder should dissolve in less than one minute at room temperature. RECOTHROM solution should remain in the vial until ready for transfer to a labeled sterile bowl or basin. 8. Withdraw reconstituted RECOTHROM solution into the attached transfer syringe labeled For topical use only, DO NOT INJECT. Use the transfer syringe for immediate transfer of RECOTHROM solution into a labeled sterile bowl or basin. 9. RECOTHROM is ready for application. RECOTHROM is for topical use only—DO NOT INJECT. See Application Techniques below (2.2). RECOTHROM vial is for single use only. Discard unused contents. 2.2 Application Techniques For topical use only. DO NOT INJECT. RECOTHROM solution should remain in the vial until ready for transfer to a labeled sterile bowl or basin. RECOTHROM Thrombin topical (Recombinant) solution is now ready to use, either with an absorbable gelatin sponge, FLOSEAL NT or used with the RECOTHROM Spray Applicator Kit for surface application. DO NOT INJECT. The amount required depends upon the area of tissue to be treated and the method of application. Vials are for single use only. Discard unused contents. Use with Absorbable Gelatin Sponge Refer to the absorbable gelatin sponge labeling for safety information and instructions on appropriate use. 1. Transfer RECOTHROM solution from transfer syringe labeled For topical use only, DO NOT INJECT to a labeled sterile bowl or basin. 2. Place the desired size pieces of the absorbable gelatin sponge into the bowl containing reconstituted RECOTHROM to completely saturate the sponge(s). 3. Remove the saturated sponge(s) and squeeze gently to remove excess RECOTHROM. 4. Apply the sponge to the bleeding site in a single layer. Use with RECOTHROM Spray Applicator Kit The RECOTHROM Spray Applicator Kit is double-packaged to allow for the aseptic transfer of the inner sterile package into a sterile field. Refer to Spray Applicator Kit instructions for use. Use in conjunction with FLOSEAL NT Hemostatic Matrix, 5mL 1. 5,000-unit RECOTHROM may be used with FLOSEAL NT Hemostatic Matrix, 5mL according to the FLOSEAL NT Hemostatic Matrix, 5mL instructions for use (IFU).
Warnings & Precautions
• RECOTHROM Thrombin topical (Recombinant) causes thrombosis if it enters the circulatory system. (5.1) • Hypersensitivity reactions, including anaphylaxis, may occur. (5.2) 5.1 Thrombosis RECOTHROM Thrombin topical (Recombinant) causes thrombosis if it enters the circulatory system. Apply topically. DO NOT INJECT. 5.2 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, may occur. RECOTHROM Thrombin topical (Recombinant) is produced in a genetically modified Chinese Hamster Ovary (CHO) cell line and may contain hamster or snake proteins [see Contraindications (4) and Description (11) ] .
Contraindications
• Do not inject directly into the circulatory system. • Do not use for the treatment of massive or brisk arterial bleeding. • Do not administer to patients with a history of hypersensitivity to RECOTHROM Thrombin topical (Recombinant) or any components of RECOTHROM. • Do not use in patients with known hypersensitivity to hamster proteins. • Do not inject directly into the circulatory system. (4) • Do not use for the treatment of massive or brisk arterial bleeding. (4) • Do not administer to patients with a history of hypersensitivity to RECOTHROM Thrombin topical (Recombinant), any components of RECOTHROM or hamster proteins. (4)
Adverse Reactions
Thromboembolic adverse reactions were reported in 6% of surgical patients treated with RECOTHROM Thrombin topical (Recombinant) in all completed clinical trials (N=644) [see Warnings and Precautions (5.1) ] . Antibody formation to RECOTHROM occurred in <1% of patients. None of the antibodies detected neutralized native human thrombin [see Adverse Reactions (6.2) ] . • The most common adverse reaction (incidence 6%) was thromboembolic events. (5.1 , 6) • Antibody formation to RECOTHROM Thrombin topical (Recombinant) occurred in <1% of patients. None of the antibodies detected neutralized native human thrombin. (6.2) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug product cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical trials have been performed with RECOTHROM Thrombin topical (Recombinant) applied with absorbable gelatin sponge and applied with a spray applicator. A total of 644 patients were exposed to RECOTHROM in these studies. RECOTHROM Thrombin topical (Recombinant) Used in Conjunction with Absorbable Gelatin Sponge Four hundred eleven (411) patients were treated in a randomized, double-blind, controlled trial that compared RECOTHROM to bovine thrombin. Both thrombins were applied with a gelatin sponge in patients undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access. 1 The incidence of thromboembolic adverse reactions was similar between the RECOTHROM and bovine thrombin treatment groups (see Table 1 ). Table 1: Incidence of Adverse Reactions with RECOTHROM Thrombin topical (Recombinant) and Bovine Thrombin Adverse Reaction Category RECOTHROM (N=205) n (%) Bovine Thrombin THROMBIN-JMI Thrombin, Topical (Bovine) (N=206) n (%) Thromboembolic events 11 (5%) 12 (6%) In an open-label, single-group trial (N=209), patients with documented or highly likely prior exposure to bovine thrombin within the previous three years were treated with RECOTHROM when undergoing surgeries (spinal, peripheral arterial bypass, or arteriovenous graft formation for hemodialysis access). 2 The incidence of thromboembolic adverse reactions in this study was 9%. In an open-label, single-group trial of re-exposure to RECOTHROM (N=31), patients with documented prior exposure to RECOTHROM were treated with RECOTHROM during surgery (spinal, peripheral arterial bypass, arteriovenous graft formation, or other procedures). 3 The incidence of thromboembolic adverse reactions in this study was 3%. In other randomized, double-blind trials across a range of surgical settings (N=130; spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access), the safety of RECOTHROM (n=88 patients) was compared to placebo (RECOTHROM excipients reconstituted with sterile 0.9% sodium chloride, USP) (n=42 patients). The incidence of thromboembolic adverse reactions in this study was 5% for RECOTHROM and 12% for placebo. RECOTHROM Thrombin topical (Recombinant) Applied with Spray Applicator RECOTHROM was applied with a spray applicator in two open-label clinical trials: a single-group trial in adult and pediatric burn patients (N=72; ≤16 years of age, (n=4) and ≥17 years of age, (n=68)) treated with RECOTHROM applied to the wound excision site prior to autologous skin grafting 4 ; and in a single-group trial in pediatric patients (one month to 17 years of age) undergoing synchronous burn wound excision and autologous skin grafting (N=30; ≤16 years of age, (n=26); ≥17 years of age, (n=4)). 5 In the first study, the incidence of thromboembolic adverse reactions was 1%. In the second study, there were no reported thromboembolic adverse reactions [see Use in Specific Populations (8.4) ] . 6.2 Immunogenicity The detection of antibody formation is highly dependent upon the sensitivity and specificity of the assay. The absolute immunogenicity rates reported here are difficult to compare with the results from other products due to differences in assay methodology, patient populations, and other underlying factors. The potential for development of antibodies to RECOTHROM Thrombin topical (Recombinant) was evaluated in multiple clinical trials and included patients with a single exposure to RECOTHROM as well as patients who were re-exposed to RECOTHROM during a subsequent surgical procedure. Only patients with both baseline and post-treatment antibody specimens available were evaluated for the development of specific anti-RECOTHROM product antibodies, which was defined as seroconversion or a ≥1.0 titer unit (≥10-fold) increase in antibody levels after study treatment. Five of 609 (0.8%; 95% CI, 0.4%-2.8%) evaluable patients developed specific anti-RECOTHROM product antibodies. None of these antibodies were found to neutralize native human thrombin. There was no difference in anti-RECOTHROM product antibody formation incidence among patients exposed to RECOTHROM applied with absorbable gelatin sponge, USP or with spray applicator. In a clinical trial comparing RECOTHROM to bovine thrombin (N=411; n=398 antibody evaluable) for the development of specific anti-product antibodies, blood samples were collected at baseline and at Day 29 in both treatment groups and were analyzed by ELISA. 1 At baseline, 1.5% of RECOTHROM patients (n=3/198) had positive anti-product antibody titers compared with 5% of bovine thrombin patients (n=10/200). Of these patients, none of the RECOTHROM group and eight in the bovine thrombin group exhibited ≥1.0 titer unit (≥10-fold) increases in anti-product antibody levels after study treatment. At Day 29, three of 198 (1.5%; 95% CI, 0%-4%) patients in the RECOTHROM group developed specific anti-product antibodies (one patient also developed anti-CHO host cell protein antibodies); 43 of 200 patients in the bovine thrombin group (22%; 95% CI, 16%-28%) developed specific antibodies to bovine thrombin product. Treatment with RECOTHROM resulted in a statistically significant lower incidence of specific anti-product antibody development. Because the study was not powered to detect a difference in clinical outcomes attributable to antibody formation, no conclusions can be drawn regarding the clinical significance of the difference in antibody formation based on the results of this study. None of the antibodies in the RECOTHROM group neutralized native human thrombin. Antibodies against bovine thrombin product were not tested for neutralization of native human thrombin. In a trial of patients with a high likelihood of prior exposure to bovine thrombin, 15.6% of patients (n=32/205) had anti-bovine thrombin product antibodies and 2% of patients (n=4/200) had anti-RECOTHROM product antibodies at baseline. 2 Following treatment, none of the 200 evaluable patients (patients for whom post-treatment specimens were available) developed antibodies to RECOTHROM. In a trial of patients previously exposed to RECOTHROM, 31 patients were re-exposed to RECOTHROM during a subsequent surgery. 3 None of the evaluable patients (n=30) had anti- RECOTHROM product antibodies at baseline and none developed antibodies at Day 29. In a trial of RECOTHROM, including 26 pediatric patients (aged one month to 16 years) and four patients 17 years of age, one patient without prior thrombin exposure had pre-existing anti-RECOTHROM product antibodies at baseline. 5 None of the 27 evaluable patients developed anti-RECOTHROM product antibodies at Day 29.
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