ARTISS- fibrinogen human thrombin human ARTISS FROZEN- fibrinogen human thrombin human solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Baxalta US Inc.

INN (International Adı):

FIBRINOGEN HUMAN

Kompozisyon:

FIBRINOGEN HUMAN 90 mg in 1 mL

Terapötik endikasyonlar:

ARTISS is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age. ARTISS is indicated to adhere tissue flaps during facial rhytidectomy surgery (face-lift). ARTISS is not indicated as an adjunct to hemostasis. Do not inject ARTISS directly into blood vessels. Intravascular application of ARTISS may result in life-threatening thromboembolic events. Do not use ARTISS in individuals with a known hypersensitivity to aprotinin and/or hypersensitivity to any of the active substances or excipients (see WARNINGS/PRECAUTIONS, Hypersensitivity/Allergic/Anaphylactic Reactions (5.1) and ADVERSE REACTIONS (6)). Pregnancy Category C Animal reproduction studies have not been conducted with ARTISS. It is also not known whether ARTISS can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Some viruses, such as parvovirus B19, are particularly difficult to remove or inact

Ürün özeti:

ARTISS is supplied in the following pack sizes and presentations: See DOSAGE FORMS AND STRENGTHS (3) . Storage Store ARTISS in original carton to protect from light. Do not use after the expiration date. Discard if packaging of any components is damaged. ARTISS Kit (Freeze-Dried) Store at 2°C to 25°C. Avoid freezing. After reconstitution, the product must be used within 4 hours. Reconstituted solutions must not be refrigerated or frozen. ARTISS Pre-filled Syringe (Frozen)

Yetkilendirme durumu:

Biologic Licensing Application

Ürün özellikleri

ARTISS- FIBRINOGEN HUMAN THROMBIN HUMAN
ARTISS FROZEN- FIBRINOGEN HUMAN THROMBIN HUMAN SOLUTION
BAXALTA US INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARTISS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ARTISS
ARTISS [FIBRIN SEALANT (HUMAN)]
FOR TOPICAL USE ONLY
FROZEN SOLUTION AND LYOPHILIZED POWDER FOR SOLUTION FOR TOPICAL
APPLICATION
INITIAL U.S. APPROVAL: 2008
RECENT MAJOR CHANGES
Indications and Usage (1.2) 08/2011
Dosage and Administration (2.3) 08/2011
Adverse Reactions (6.1) 08/2011
INDICATIONS AND USAGE
ARTISS is indicated to adhere autologous skin grafts to surgically
prepared wound beds resulting from burns in adult
and pediatric populations greater than or equal to 1 year of age (1.1)
ARTISS is indicated to adhere tissue flaps during facial rhytidectomy
surgery (face-lift) (1.2)
ARTISS is not indicated as an adjunct to hemostasis (1)
DOSAGE AND ADMINISTRATION
FOR TOPICAL USE ONLY. DO NOT INJECT (2). APPLY ON SURFACE OF PREPARED
WOUND BEDS ONLY (2.3)
ARTISS Kit (Freeze-Dried) requires reconstitution prior to use (2.1)
ARTISS Pre-filled Syringe (Frozen) requires thawing prior to use (2.2)
Apply as a thin layer using the Easyspray and Spray Set (2.3, 5.2)
Dosage: 2 mL will cover approximately 100 cm surface area (2)
Vials and pre-filled syringes are for single use only. Discard unused
contents (2.3)
DOSAGE FORMS AND STRENGTHS
ARTISS is available as a two-component fibrin sealant, including
Sealer Protein (Human) and Thrombin (Human), in two
dosage forms, 2 mL, 4 mL and 10 mL Freeze-Dried Kit and 2 mL, 4 mL and
10 mL Frozen Solution in Pre-filled Syringe (3)
CONTRAINDICATIONS
Do not inject directly into the circulatory system (4.1)
Do not use in individuals with a known hypersensitivity to aprotinin
(4.2, 5.1)
WARNINGS AND PRECAUTIONS
Hypersensitivity or allergic/anaphylactoid reactions may occur with
the use of ARTISS (5.1)
Air or gas embolism has occurred with the use of spray devices
employing pressure regulator