Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
FIBRINOGEN HUMAN (UNII: N94833051K) (FIBRINOGEN HUMAN - UNII:N94833051K), HUMAN THROMBIN (UNII: 6K15ABL77G) (HUMAN THROMBIN - UNII:6K15ABL77G)
Baxalta US Inc.
FIBRINOGEN HUMAN
FIBRINOGEN HUMAN 90 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
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 not indicated for 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, Overall Adverse Reactions (6.1)). 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 inactivate at this time. Parvovirus B19 most seriously affects pregnant women (f
ARTISS is supplied in the following pack sizes and presentations: See DOSAGE FORMS AND STRENGTHS, Package Contents (3.2) . Storage Store ARTISS in original carton to protect from light. 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) Do not use after the expiration date. Discard if packaging of any components is damaged.
Biologic Licensing Application
ARTISS FROZEN- FIBRINOGEN HUMAN THROMBIN HUMAN SOLUTION ARTISS- FIBRINOGEN HUMAN THROMBIN HUMAN 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 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) ARTISS is not indicated for 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 Kit (Freeze-Dried) is supplied as 2 mL, 4 mL and 10 mL (total volume) pack sizes with and without the DUPLOJECT system (3.1) ARTISS Pre-filled Syringe (Frozen) is supplied as 2 mL, 4 mL and 10 mL (total volume) pack sizes with the DUO set (3.1) 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, 6.1) WARNINGS AND PRECAUTIONS Apply only as thin layer (2.3, 5.2) Air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer fibrin sealants. This event appears to be related to the use of the spray device at higher than recommended pressures and in close proximity to the surface of the tissue (5.2) Exposure to solutions containing alcohol, iodine or heavy metals may cause ARTISS to Olvassa el a teljes dokumentumot