TISSEEL FROZEN- fibrinogen human and thrombin human solution TISSEEL- fibrinogen human and thrombin human

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Baxalta US Inc.

INN (International Nazwa):

FIBRINOGEN

Skład:

FIBRINOGEN 90 [iU] in 1 mL

Droga podania:

TOPICAL

Wskazania:

TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in surgeries involving cardiopulmonary bypass and treatment of blunt or penetrating splenic injuries when control of bleeding by conventional surgical techniques, including suture, ligature, and cautery, is ineffective or impractical. TISSEEL is a hemostatic agent that may be used in fully heparinized patients undergoing cardiopulmonary bypass. TISSEEL is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies. Do not inject TISSEEL directly into the circulatory system or into highly vascularized tissue. Intravascular application of TISSEEL can lead to intravascular coagulation, may result in life-threatening thromboembolic events, and may increase the likelihood and severity of acute hypersensitivity reactions in susceptible patients (see WARNINGS AND PRECAUTIONS, Use in Cardiopulmonary Surgery (5.3

Podsumowanie produktu:

TISSEEL is supplied in the following pack sizes and presentations: Storage TISSEEL Kit (Freeze-Dried) Store at 2°C to 25°C. Avoid freezing. After reconstitution, the product must be used within 4 hours. Do not freeze or refrigerate reconstituted solutions. TISSEEL Pre-filled Syringe (Frozen) Room Temperature Thawing: Unopened pouches may be stored for up to 48 hours at room temperature (15-25°C). Quick Thawing: Maintain the product at 33-37°C until use. If the package is opened or warmed to 33-37°C it must be used within 4 hours. Do not use after the expiration date. Discard if packaging of any components is damaged.

Status autoryzacji:

Biologic Licensing Application

Charakterystyka produktu

TISSEEL FROZEN- FIBRINOGEN HUMAN AND THROMBIN HUMAN SOLUTION
TISSEEL- FIBRINOGEN HUMAN AND THROMBIN HUMAN
BAXALTA US INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TISSEEL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TISSEEL.
TISSEEL [FIBRIN SEALANT]
FOR TOPICAL USE ONLY
FROZEN SOLUTION AND LYOPHILIZED POWDER FOR SOLUTION FOR TOPICAL
APPLICATION
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Adverse Reactions; Post Marketing (6.3) 11/2009
INDICATIONS AND USAGE
HEMOSTASIS: TISSEEL is a fibrin sealant indicated for use as an
adjunct to hemostasis in surgeries involving
cardiopulmonary bypass and treatment of blunt or penetrating splenic
injuries when control of bleeding by conventional
surgical techniques, including suture, ligature, and cautery, is
ineffective or impractical. TISSEEL is a hemostatic agent
that may be used in fully heparinized patients undergoing
cardiopulmonary bypass (1.1)
SEALING: TISSEEL is a fibrin sealant indicated as an adjunct to
standard surgical techniques (such as suture and
ligature) to prevent leakage from colonic anastomoses following the
reversal of temporary colostomies (1.2)
DOSAGE AND ADMINISTRATION
FOR TOPICAL USE ONLY. DO NOT INJECT (2)
TISSEEL Kit (Freeze-Dried) requires reconstitution prior to use (2.1)
TISSEEL Pre-filled Syringe (Frozen) requires thawing prior to use
(2.2)
Apply TISSEEL as a thin layer (2.3, 5.2)
Vials and pre-filled syringes are for single use only. Discard unused
contents (2.3)
To ensure adequate mixing, expel and discard the first several drops
from the cannula in cases where very small volumes
(1-2 drops) are applied (2.3)
DOSAGE FORMS AND STRENGTHS
TISSEEL Kit (Freeze-Dried) is supplied as 2 mL, 4 mL and 10 mL (total
volume) pack sizes with and without the
DUPLOJECT System (3.1).
TISSEEL Pre-filled Syringe (Frozen) is supplied as 2 mL, 4 mL and 10
mL (total volume) pack sizes with the DUO Set (3.1).
CONTRAINDICATIONS
Do not inject directly into the circulatory syst