EVARREST 8.6 mg/cm2
Fibrinogen Human and Human Thrombin · PATCH · Ethicon, Inc.
EVARREST is a patch containing fibrinogen human and human thrombin at 8.6 mg/cm2, taken topical. Manufactured by Ethicon, Inc..
Key Facts
- Brand Name
- EVARREST
- Generic Name
- Fibrinogen Human and Human Thrombin
- NDC Code (Product)
63713-050- Manufacturer
- Ethicon, Inc.
- Strength
- 8.6 mg/cm2
- Dosage Form
- PATCH
- Route
- TOPICAL
- Marketing Status
- Application #
- BLA125392
- Marketing Start
- 03/01/2013
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. Limitations for Use TachoSil cannot safely or effectively be used in place of sutures or other form of mechanical ligation for the treatment of major arterial or venous bleeding. Not for use in children under one month of age. TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. ( 1 ) Limitations for Use Not for use in place of sutures or other forms of mechanical ligation in treatment of major arterial or venous bleeding. ( 1 ) Not for use in children under one month of age. ( 8.4 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For topical use on cardiovascular or hepatic tissue only Determine the number of patches to be applied by the size of the bleeding area. Apply the yellow, active side of the patch to the bleeding area. When applying TachoSil, do not exceed the maximum number of patches shown in Table 1 [see Warnings and Precautions (5.6) ] . Table 1. Amount of Fibrinogen and Thrombin per Total Patch Size and Maximum Number of TachoSil Patches to be Applied TachoSil Patch Size Human Fibrinogen (mg) Human Thrombin (Units) Maximum Number of Patches to be Applied 3.7 inch x 1.9 inch (9.5 cm x 4.8 cm) 337.4 123.1 10 1.9 inch x 1.9 inch (4.8 cm x 4.8 cm) 170.5 62.2 14 Apply on the surface of cardiovascular or hepatic tissue only. • Determine the number of TachoSil patches to be applied by the size of the bleeding area. ( 2 ) • Apply the yellow, active side of the patch to the bleeding surface. ( 2 ) 2.1 Preparation for Application TachoSil comes ready to use in sterile packages and must be handled using sterile technique in aseptic conditions. Discard damaged packages as resterilization is not possible. When in the operating room, the outer aluminum foil pouch may be opened in…
Contraindications
4 CONTRAINDICATIONS Do not use TachoSil for: • Intravascular application. Bleeding from large defects in visible arteries or veins where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of TachoSil to blood flow during absorption of the product. This can result in life-threatening thromboembolic events [see Warnings and Precautions (5.1) ] . • Individuals known to have anaphylactic or severe systemic reaction to human blood products or horse proteins [see Warnings and Precautions (5.2) ] . Do not apply TachoSil intravascularly. Intravascular application of TachoSil may result in life-threatening thromboembolic events. ( 4 ) Do not use TachoSil in individuals with known hypersensitivity to human blood products or horse proteins. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The adverse reactions reported in more than one percent of patients during clinical trials were anemia, nausea and vomiting, fever, abdominal pain, increased white blood cell count, ascites, itching, atrial fibrillation, pleural effusion, gastrointestinal hemorrhage, wound infection, hypophosphatemia, urinary tract infection, and post-procedural bile leakage in hepatic surgery. The most common adverse reactions reported in >1% of patients during clinical trials were anemia, nausea and vomiting, fever, abdominal pain, increased white blood cell count, ascites, itching, atrial fibrillation, pleural effusion, gastrointestinal hemorrhage, wound infection, hypophosphatemia, urinary tract infection and post-procedural bile leakage in hepatic surgery. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Corza Medical GmbH at 1-800-997-1067 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 cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed i…
Frequently Asked Questions
What is EVARREST used for?
EVARREST contains Fibrinogen Human and Human Thrombin. It is a patch taken topical. Consult your doctor for specific uses.
Is EVARREST a controlled substance?
EVARREST is not classified as a controlled substance by the DEA.
What is the generic name for EVARREST?
The generic name for EVARREST is Fibrinogen Human and Human Thrombin. There are no other listed brand versions of Fibrinogen Human and Human Thrombin.
What is the NDC code for EVARREST 8.6 mg/cm2?
The NDC (National Drug Code) for EVARREST 8.6 mg/cm2 is 63713-050, listed by Ethicon, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)