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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FIBRINOGEN HUMAN (UNII: N94833051K) (FIBRINOGEN HUMAN - UNII:N94833051K)

Available from:

Baxalta US Inc.

INN (International Name):

FIBRINOGEN HUMAN

Composition:

FIBRINOGEN HUMAN 90 mg in 1 mL

Therapeutic indications:

TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. 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, can result in life-threatening thromboembolic events, and can increase the likelihood and severity of acute hypersensitivity reactions in susceptible patients (see Warnings and Precautions(5.3) and Adverse Reactions (6.2)).   Do not use TISSEEL in individuals with a known hypersensitivity to aprotinin  (see Warnings and Pre

Product summary:

How Supplied TISSEEL is supplied in the following pack sizes and presentations: TISSEEL Kit contains one vial each of: 1. Sealer Protein Concentrate (Human), Vapor Heated, Solvent/Detergent Treated, Freeze-Dried, Sterile 2. Fibrinolysis Inhibitor Solution, (Synthetic) Liquid, Sterile 3. Thrombin (Human), Vapor Heated, Solvent/Detergent Treated, Freeze-Dried, Sterile 4. Calcium Chloride Solution, Liquid, Sterile TISSEEL Pre-Filled Dual-Chambered Syringe contains: 1. Sealer Protein Solution, Vapor Heated, Solvent/Detergent Treated, Frozen Solution, Sterile 2. Thrombin Solution, Vapor Heated, Solvent/Detergent Treated, Frozen Solution, Sterile 3. Sterile accessory devices (DUO Set: 1 plunger, 2 joining pieces and 4 application cannulas) Storage TISSEEL Kit (Freeze-Dried) Store at 2 - 25°C. Avoid freezing. Do not freeze or refrigerate reconstituted solutions. TISSEEL Pre-filled Syringe (Frozen) Store at ≤ -20°C. Do not refrigerate or re-freeze after thawing. Do not use after the expiration date. Discard if packaging of any components is damaged.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

TISSEEL- FIBRINOGEN HUMAN AND THROMBIN HUMAN
TISSEEL FROZEN- FIBRINOGEN HUMAN AND THROMBIN HUMAN SOLUTION
BAXALTA US INC.
REFERENCE LABEL SET ID: 31BC99F4-C504-4E6A-8BB6-FE8F7A5C2424
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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
Indications and Usage (1) 09/2013
INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION
FOR TOPICAL USE ONLY. DO NOT INJECT (2)
Apply TISSEEL as a thin layer by dripping or spraying using cannula or
spray set (2.3, 5.2)
Ensure that the amount of TISSEEL to be applied is sufficient to
entirely cover the intended application area (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)
TISSEEL Pre-filled Syringe (Frozen) is supplied as 2 mL, 4 mL and 10
mL (total volume) pack sizes with the DUO Set (3)
CONTRAINDICATIONS
Do not inject directly into the circulatory system or into highly
vascularized tissue (4.1, 5.3)
Do not use in individuals with a known hypersensitivity to aprotinin
(4.2, 5.1, 6)
Do not use for the treatment of severe or brisk arterial or venous
bleeding (4.3)
WARNINGS AND PRECAUTIONS
TISSEEL contains aprotinin, a protein known to be associated with
anaphylactic reactions (4.2, 5.1,6)
Air or gas embolism has occurred when fibrin sealant was administered
using pressurized gas. This can occur if a spray
device is used at higher than recommended pressures and in close
proximity to the surface of the tissue (5.2)
TISSEEL is denatured when exposing to solutions containing alcohol,
iodine or heavy metals (5.2)
Apply only as a thin layer as excess clot thickness can negatively
interfere with wound healing (2,5.2)
Exercise caution to minimize the risk of intravascular ap