Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
HUMAN THROMBIN (UNII: 6K15ABL77G) (HUMAN THROMBIN - UNII:6K15ABL77G), FIBRINOGEN HUMAN (UNII: N94833051K) (FIBRINOGEN HUMAN - UNII:N94833051K)
Baxter Healthcare Corporation
HUMAN THROMBIN
HUMAN THROMBIN 2.0 [USP'U]
TOPICAL
PRESCRIPTION DRUG
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 Do not use TachoSil for: Risk Summary A review of available data suggests that major birth defects occur in 2-4% of the U.S. general population and that miscarriage occurs in 15-20% of clinically recognized pregnancies, regardless of drug exposure. Animal reproduction studies have not been conducted with TachoSil. There are no adequate and well-controlled studies in pregnant women. It is also not known whether TachoSil can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TachoSil should be administered to pregnant women only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, ca
Each TachoSil patch is packaged individually in a tray with lidding. This is placed in an outer pouch with a desiccant bag and packaged into a folding carton. TachoSil is supplied in the following pack sizes: (NDC 0338-8701-01) (NDC 0338-8702-02) Storage •Use TachoSil before expiration date indicated on the package. •Store unopened packages of TachoSil between 2ºC and 25ºC. TachoSil does not require refrigeration. Do not freeze. •Do not use if package is opened or damaged.
Biologic Licensing Application
TACHOSIL- THROMBIN HUMAN AND FIBRINOGEN PATCH BAXTER HEALTHCARE CORPORATION ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TACHOSIL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TACHOSIL. TACHOSIL FIBRIN SEALANT PATCH ABSORBABLE PATCH FOR TOPICAL USE INITIAL U.S. APPROVAL: 2010 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. (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 AND ADMINISTRATION Apply on the surface of cardiovascular or hepatic tissue only. • • DOSAGE FORMS AND STRENGTHS • • CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • • • • ADVERSE REACTIONS The most common adverse reactions reported in >1% of patients during clinical trials were anemia, ® 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) TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge. Each absorbable patch contains, per square inch (inch ): human fibrinogen 23.2 to 47.7 mg (35.5 mg); human thrombin 8.4 to 17.4 Units (12.9 U) per cm : human fibrinogen 3.6 to 7.4 mg (5.5 mg); human thrombin 1.3 to 2.7 Units (2.0 U). (3) 2 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) Thrombosis can occur if TachoSil is applied Przeczytaj cały dokument