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ARTISS is a brand name for Aprotinin, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
and 7 WARNINGS AND PRECAUTIONS, Vascular Disorders) • Severe hypersensitivity and anaphylactic reactions have been reported with ARTISS. ) • ARTISS is made from pooled human plasma which may contain infectious agents, such as viruses, that can cause disease (see 7 WARNINGS AND PRECAUTIONS, General) 4.
2. Recommended Dose and Dosage Adjustment Application of the product must be individualized to the patient by the treating physician. 2-12 mL. , the sealing of large, burned surfaces), larger volumes may be required. The initial amount of the product to be applied at a chosen anatomic site or target surface area should be sufficient to entirely cover the intended application area.
The application can be repeated, if necessary. However, avoid re-application of ARTISS (Fibrin Sealant (Human), Slow Set) to a pre-existing polymerized ARTISS layer as ARTISS may not adhere firmly to a polymerized layer. The amount of ARTISS to be applied depends on the size of the surface to be covered.
4. Administration For topical use only – do not inject. ARTISS is available as frozen solutions for thawing. ARTISS consists of a pre-filled double-chamber syringe (PRIMA syringe) containing Sealer Area to be sealed (cannula, catheter) Area to be sealed using compressed gas (spray application) Required package size of ARTISS 8 cm2 16 cm2 40 cm2 25-100 cm2 50-200 cm2 125-500 cm2 2 mL 4 mL 10 L ARTISS, Fibrin Sealant (Human), Slow Set Page 6 of 42 Protein-Aprotinin Solution and Thrombin-Calcium Chloride Solution.
ARTISS is available in 2, 4 and 10 mL pack sizes. Various methods can be used to simultaneously apply the two components of ARTISS: • using application cannula contained in DUPLOJECT COMBI • using TISSEEL / ARTISS Spray Set and EASYSPRAY Pressure Regulator • using DUPLOCATH Application Catheters or other accessories provided by Baxter Preparation of ARTISS • Do not use ARTISS unless it is completely thawed and warmed (liquid consistency).
• ARTISS must not be exposed to temperatures above 37°C and must not be microwaved. • The protective syringe cap should not be removed until thawing is complete, and application tip is ready to be attached. ARTISS may be thawed and warmed under controlled conditions using one of the two following options: Quick Thawing/Warming Methods An Overview of the quick thawing/warming methods is provided in Table 2 Table 2: Quick Thawing /Warming Methods at 33°C – 37°C Pack Size Minimum Thawing/Warming Times Sterile Water Bath (Pouches Removed) Non-Sterile Water Bath (In Pouches) Incubator (In Pouches) 2 mL 5 min 15 min 40 min 4 mL 5 min 20 min 50 min 10 mL 10 min 35 min 90 min Sterile Water Bath (Recommended Method) • Transfer the pre-filled syringe packed in the inner pouch into the sterile area.
• Remove the pre-filled syringe from the inner pouch and place the syringe directly into the sterile water heated to 33°C - 37°C ensuring the syringe is completely immersed in the water (See Table 2 for minimum thawing/warming times).
, Vascular Disorders). ARTISS, Fibrin Sealant (Human), Slow Set Page 5 of 42 • Fatal air or gas embolism has occurred with application of ARTISS using pressurized air or gas (see 4 DOSAGE AND ADMINISTRATION and 7 WARNINGS AND PRECAUTIONS, Vascular Disorders) • Severe hypersensitivity and anaphylactic reactions have been reported with ARTISS.
) • ARTISS is made from pooled human plasma which may contain infectious agents, such as viruses, that can cause disease (see 7 WARNINGS AND PRECAUTIONS, General) 4. 2. Recommended Dose and Dosage Adjustment Application of the product must be individualized to the patient by the treating physician.
2-12 mL. , the sealing of large, burned surfaces), larger volumes may be required. The initial amount of the product to be applied at a chosen anatomic site or target surface area should be sufficient to entirely cover the intended application area.
The application can be repeated, if necessary. However, avoid re-application of ARTISS (Fibrin Sealant (Human), Slow Set) to a pre-existing polymerized ARTISS layer as ARTISS may not adhere firmly to a polymerized layer. The amount of ARTISS to be applied depends on the size of the surface to be covered.
4. Administration For topical use only – do not inject. ARTISS is available as frozen solutions for thawing. ARTISS consists of a pre-filled double-chamber syringe (PRIMA syringe) containing Sealer Area to be sealed (cannula, catheter) Area to be sealed using compressed gas (spray application) Required package size of ARTISS 8 cm2 16 cm2 40 cm2 25-100 cm2 50-200 cm2 125-500 cm2 2 mL 4 mL 10 L ARTISS, Fibrin Sealant (Human), Slow Set Page 6 of 42 Protein-Aprotinin Solution and Thrombin-Calcium Chloride Solution.
ARTISS is available in 2, 4 and 10 mL pack sizes. Various methods can be used to simultaneously apply the two components of ARTISS: • using application cannula contained in DUPLOJECT COMBI • using TISSEEL / ARTISS Spray Set and EASYSPRAY Pressure Regulator • using DUPLOCATH Application Catheters or other accessories provided by Baxter Preparation of ARTISS • Do not use ARTISS unless it is completely thawed and warmed (liquid consistency).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Aprotinin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
• To monitor the specified temperature range, control the water temperature using a thermometer and change the water as necessary. Non-Sterile Water Bath • Place the pre-filled syringe packed in both pouches, in a water bath heated to 33°C - 37°C outside the sterile area, ensuring the pouches remain immersed in the water (See Table 2 for minimum thawing/warming times).
ARTISS, Fibrin Sealant (Human), Slow Set Page 7 of 42 • Remove the pouches from the water bath after thawing and warming. • Dry the outer pouch and transfer the pre-filled syringe in the inner pouch, onto the sterile area. Incubator • Place the pre-filled syringe, packed in both pouches, in an incubator outside the sterile area (See Table 2 for minimum thawing/warming times).
• After thawing/warming in the incubator, remove the outer pouch and transfer the pre- filled syringe, inside the inner pouch, into the sterile area. Thawing at Room Temperature (not above +25°C) followed by Warming in Incubator • Thaw the pre-filled syringe, packed in both pouches, at room temperature outside the sterile area (See Table 3 for minimum thawing times).
• Warm the pre-filled syringe, packed in both pouches, in an incubator at 33°C-37°C outside the sterile area (See Table 3 for minimum thawing/warming times). • After thawing/warming in the incubator, remove the outer pouch and transfer the pre- filled syringe, inside the inner pouch, into the sterile area.
Table 3:
Thawing at Room Temperature and warming in Incubator Pack Size Minimum Thawing/Warming Times Thawing at Room Temperature (Not above +25⁰C) Warming in Incubator (33⁰C-37⁰C) 2 mL 80 min 11min 4 mL 90 min 13 min 10 mL 160 min 25 min Stability after Thawing After quick thawing and warning: Once the package is opened or the product is warmed to 33°C to 37°C, it must be used within 12 hours.
Product thawed at room temperature:
Unopened pouches of ARTISS, may be stored for up to 7 days at room temperature (15°C to 25°C) after removal from the freezer. After thawing, the product must not be refrigerated or, refrozen. Method of Application Application Considerations See 7 WARNINGS AND PRECAUTIONS, General and Application Precautions.
The use of ARTISS is restricted to experienced surgeons who have been trained in the use of ARTISS. The setting rate depends on the concentration of human Thrombin contained in the Thrombin- ARTISS, Fibrin Sealant (Human), Slow Set Page 8 of 42 Calcium Chloride solution used.
The ARTISS Thrombin component is provided in a 4 IU/mL concentration. Time to clot formation/ […]
• ARTISS must not be exposed to temperatures above 37°C and must not be microwaved. • The protective syringe cap should not be removed until thawing is complete, and application tip is ready to be attached. ARTISS may be thawed and warmed under controlled conditions using one of the two following options: Quick Thawing/Warming Methods An Overview of the quick thawing/warming methods is provided in Table 2 Table 2: Quick Thawing /Warming Methods at 33°C – 37°C Pack Size Minimum Thawing/Warming Times Sterile Water Bath (Pouches Removed) Non-Sterile Water Bath (In Pouches) Incubator (In Pouches) 2 mL 5 min 15 min 40 min 4 mL 5 min 20 min 50 min 10 mL 10 min 35 min 90 min Sterile Water Bath (Recommended Method) • Transfer the pre-filled syringe packed in the inner pouch into the sterile area.
• Remove the pre-filled syringe from the inner pouch and place the syringe directly into the sterile water heated to 33°C - 37°C ensuring the syringe is completely immersed in the water (See Table 2 for minimum thawing/warming times).
• To monitor the specified temperature range, control the water temperature using a thermometer and change the water as necessary. Non-Sterile Water Bath • Place the pre-filled syringe packed in both pouches, in a water bath heated to 33°C - 37°C outside the sterile area, ensuring the pouches remain immersed in the water (See Table 2 for minimum thawing/warming times).
ARTISS, Fibrin Sealant (Human), Slow Set Page 7 of 42 • Remove the pouches from the water bath after thawing and warming. • Dry the outer pouch and transfer the pre-filled syringe in the inner pouch, onto the sterile area. Incubator • Place the pre-filled syringe, packed in both pouches, in an incubator outside the sterile area (See Table 2 for minimum thawing/warming times).
• After thawing/warming in the incubator, remove the outer pouch and transfer the pre- filled syringe, inside the inner pouch, into the sterile area. Thawing at Room Temperature (not above +25°C) followed by Warming in Incubator • Thaw the pre-filled syringe, packed in both pouches, at room temperature outside the sterile area (See Table 3 for minimum thawing times).
• Warm the pre-filled syringe, packed in both pouches, in an incubator at 33°C-37°C outside the sterile area (See Table 3 for minimum thawing/warming times). • After thawing/warming in the incubator, remove the outer pouch and transfer the pre- filled syringe, inside the inner pouch, into the sterile area.
Table 3:
Thawing at Room Temperature and warming in Incubator Pack Size Minimum Thawing/Warming Times Thawing at Room Temperature (Not above +25⁰C) Warming in Incubator (33⁰C-37⁰C) 2 mL 80 min 11min 4 mL 90 min 13 min 10 mL 160 min 25 min Stability after Thawing After quick thawing and warning: Once the package is opened or the product is warmed to 33°C to 37°C, it must be used within 12 hours.
Product thawed at room temperature:
Unopened pouches of ARTISS, may be stored for up to 7 days at room temperature (15°C to 25°C) after removal from the freezer. After thawing, the product must not be refrigerated or, refrozen. Method of Application Application Considerations See 7 WARNINGS AND PRECAUTIONS, General and Application Precautions.
The use of ARTISS is restricted to experienced surgeons who have been trained in the use of ARTISS. The setting rate depends on the concentration of human Thrombin […]