TACHOSIL- thrombin human and fibrinogen patch

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

HUMAN THROMBIN (UNII: 6K15ABL77G) (HUMAN THROMBIN - UNII:6K15ABL77G), FIBRINOGEN HUMAN (UNII: N94833051K) (FIBRINOGEN HUMAN - UNII:N94833051K)

זמין מ:

Baxter Healthcare Corporation

INN (שם בינלאומי):

HUMAN THROMBIN

הרכב:

HUMAN THROMBIN 2.0 [USP'U]

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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

leaflet_short:

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.

מצב אישור:

Biologic Licensing Application

מאפייני מוצר

TACHOSIL- THROMBIN HUMAN AND FIBRINOGEN PATCH
BAXTER HEALTHCARE CORPORATION
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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.
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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