Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
FIBRINOGEN HUMAN (UNII: N94833051K) (FIBRINOGEN HUMAN - UNII:N94833051K)
Baxalta US Inc.
FIBRINOGEN HUMAN
FIBRINOGEN HUMAN 90 mg in 1 mL
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
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)
Biologic Licensing Application
ARTISS- FIBRINOGEN HUMAN THROMBIN HUMAN ARTISS FROZEN- FIBRINOGEN HUMAN THROMBIN HUMAN SOLUTION BAXALTA US INC. ---------- 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 Lire le document complet