Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
Fibrinogen Human (UNII: N94833051K) (Fibrinogen Human - UNII:N94833051K)
Ethicon Inc
Fibrinogen Human
Fibrinogen Human 85 mg in 1 mL
EVICEL® fibrin sealant (human) is indicated as an adjunct to hemostasis for use in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical. Do not use EVICEL®: - Directly into the circulatory system. Intravascular application of EVICEL® may result in life-threatening thromboembolic events [see Warnings and Precautions, (5.1) and Adverse Reactions, (6.2)]. - In individuals known to have anaphylactic or severe systemic reaction to human blood products [see Adverse Reactions (6.2)]. - For brisk arterial bleeding. - For spraying in endoscopic or laparoscopic procedures in those instances where the minimum recommended distance from the applicator tip to the target site cannot be ensured. [see Dosage and Administration (2.3)]. Risk Summary There are no data with EVICEL® use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with EVICEL® . It is not known whether
EVICEL® is supplied as a kit consisting of two separate packages: The different EVICEL® dosage strengths include the following sizes (Table 10): The vials must be stored in an upright position. Store frozen vials at -18°C or colder (frozen) for up to 2 years. Store unopened vials at 2°C to 8°C (refrigerated) for up to 30 days. The two EVICEL® components, BAC2 and Thrombin, have been shown to be stable for up to 24 hours at room temperature. Do not use after the expiration date stated on the box, or after 30 days if stored at 2°C to 8°C after thawing. Do not re-freeze EVICEL® once it has been thawed. Do not refrigerate EVICEL® once it has reached room temperature. Discard unused product after 24 hours at room temperature. Discard if the packaging of EVICEL® is damaged. Vials are for single use only. Discard unused contents.
Biologic Licensing Application
EVICEL FIBRIN SEALANT (HUMAN)- FIBRINOGEN HUMAN AND THROMBIN HUMAN ETHICON INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE EVICEL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EVICEL . EVICEL (FIBRIN SEALANT [HUMAN]) FROZEN SOLUTIONS, FOR TOPICAL USE ONLY INITIAL U.S. APPROVAL: 2003 RECENT MAJOR CHANGES APPLICATION TECHNIQUES (2.3) (03/2018) APPLICATION PRECAUTIONS (5.1) (03/2018) INDICATIONS AND USAGE EVICEL is a Fibrin Sealant (Human) indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical (1) DOSAGE AND ADMINISTRATION FOR TOPICAL USE ONLY. DO NOT INJECT DIRECTLY INTO THE CIRCULATORY SYSTEM (2, 4). After thawing, use the two components of EVICEL (BAC2 and Thrombin) within 24 hours if stored at room temperature, or within 30 days if stored refrigerated (2.2). EVICEL is applied onto the tissue surface using a variety of application tips and techniques. To reduce the risk of potentially life-threatening gas embolism when spraying EVICEL , spray using only pressurized CO gas at the pressures and distances recommended for specific tips (2, 3). The amount of EVICEL required depends upon the area of tissue to be treated and the method of application. Vials are for single use only. Discard unused contents (2.3, 16). DOSAGE FORMS AND STRENGTHS EVICEL is supplied as a kit consisting of two separate packages (3): A package containing one vial each of BAC2 (55–85 mg/ml fibrinogen) and Thrombin (800–1200 IU/ml human thrombin) frozen solutions. A modular application device which includes a 6 cm yellow flexible tip. Optional accessory tips are distributed se pe rate ly. The different EVICEL dosage strengths include the following sizes (3): BAC2 VIAL SIZE THROMBIN VIAL SIZE PACKAGE SIZE 1.0 ml 1.0 ml 2.0 ml 2.0 ml 2.0 ml 4.0 ml 5.0 ml 5.0 ml 10.0 ml CONTRAINDICATIONS Do not inject directly into Lue koko asiakirja