RECOTHROM
thrombin topical recombinant · KIT · Baxter Healthcare Corporation
RECOTHROM is a kit containing thrombin topical recombinant. Manufactured by Baxter Healthcare Corporation.
Key Facts
- Brand Name
- RECOTHROM
- Generic Name
- thrombin topical recombinant
- NDC Code (Product)
0338-0330- Manufacturer
- Baxter Healthcare Corporation
- Dosage Form
- KIT
- Marketing Status
- Application #
- BLA125248
- Marketing Start
- 06/09/2008
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND 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
2 DOSAGE AND 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…
Contraindications
4 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
6 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 gelati…
Frequently Asked Questions
What is RECOTHROM used for?
RECOTHROM contains thrombin topical recombinant. It is a kit taken as directed. Consult your doctor for specific uses.
Is RECOTHROM a controlled substance?
RECOTHROM is not classified as a controlled substance by the DEA.
What is the generic name for RECOTHROM?
The generic name for RECOTHROM is thrombin topical recombinant. There are no other listed brand versions of thrombin topical recombinant.
What is the NDC code for RECOTHROM ?
The NDC (National Drug Code) for RECOTHROM is 0338-0330, listed by Baxter Healthcare Corporation.
Other RECOTHROM Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)