Artiss

Artiss

Manufacturer:

Baxter

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per mL of component 1 Human fibrinogen 91 mg, aprotinin 3,000 KIU. Per mL of component 2 Human thrombin 4 IU, Ca chloride 40 micromol
Indications/Uses
Tissue glue to adhere/seal SC tissue in plastic, reconstructive & burn surgery, as a replacement or an adjunct to sutures or staples.
Dosage/Direction for Use
Individualized dosage ranging from 0.2-12 mL. Surfaces gluing 2 mL for at least 10 cm2 area.
Contraindications
Hypersensitivity. Replace skin sutures intended to close surgical wounds, massive & brisk arterial or venous bleeding. Intravascular application.
Special Precautions
Not to be used as inj. Not for hemostasis & sealing in situations where a fast sealant clotting is required. Not recommended for laparoscopic surgery. Not for use in neurosurgery & suture support for GI or vascular anastomoses. Hypersensitivity, allergies to bovine proteins. Soft tissue inj. Application using pressurized air or gas. Excessive clot thickness may negatively interfere w/ efficacy & wound healing process. Monitor changes in BP, pulse, O2 saturation & end tidal CO2. Ensure sufficient protection/cover to parts outside the designated application area to prevent tissue adhesion at undesired sites. Discontinue use if any hypersensitivity reactions occur. Perform selection of donors, screening of individual donations & plasma pools for specific markers of infection & inclusion of effective manufacturing steps for inactivation/removal of viruses to prevent transmitting infections. Parvovirus B19 infection in pregnant women & individuals w/ immunodeficiency or increased erythropoiesis eg, hemolytic anemia. Concurrent use w/ oxycellulose-containing prep as carrier materials. Pregnancy & lactation. Patients >65 yr.
Adverse Reactions
Hypersensitivity or allergic reactions. Pruritus; skin graft failure.
Drug Interactions
Reduced efficacy w/ oxycellulose-containing prep. Denaturation after exposure to soln containing alcohol, iodine or heavy metals (eg, antiseptic soln).
MIMS Class
ATC Classification
B02BC30 - combinations ; Belongs to the class of local hemostatics. Used in the treatment of hemorrhage.
Presentation/Packing
Form
Artiss soln for sealant
Packing/Price
(single-use double chamber) 2 mL x 2's (RM750.00/syringe)
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