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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Baxalta US Inc.

INN (International Name):

FIBRINOGEN HUMAN

Composition:

FIBRINOGEN HUMAN 90 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

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
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