EVICEL FIBRIN SEALANT (HUMAN)- fibrinogen human and thrombin human kit

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Fibrinogen Human (UNII: N94833051K) (Fibrinogen Human - UNII:N94833051K)

Mevcut itibaren:

Ethicon Inc

INN (International Adı):

Fibrinogen Human

Kompozisyon:

Fibrinogen Human 85 mg in 1 mL

Terapötik endikasyonlar:

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

Ürün özeti:

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.

Yetkilendirme durumu:

Biologic Licensing Application

Ürün özellikleri

EVICEL FIBRIN SEALANT (HUMAN)- FIBRINOGEN HUMAN AND THROMBIN HUMAN
ETHICON INC
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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