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How Supplied/Storage and Handling : 500 mL sterile solution in a non-PVC plastic container with a sterile, non-pyrogenic fluid path. The InterSol solution container is supplied in a vented plastic overwrap covering that serves as a dust cover for the container. The dust cover is not a sterility barrier and is not an element that defines the expiration date of the InterSol product. © 2021 Fresenius Kabi AG. All rights reserved. Fresenius Kabi AG 61346 Bad Homburg / Germany Tel.: +49 (0) 61 72 / 686-0 www.fresenius-kabi.com ensymbols; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL L6B7850 NDC No. 0942-9603-12 Solamente Rx 500 mL Solución InterSol Solución aditiva para plaquetas 3 Para ser usada exclusivamente con el separador AMICUS. Almacenar a temperatura ambiente controlada. Proteger de la congelación. Evitar el calor excesivo. Deseche la porción no utilizada. Cada 100 mL contienen 305 mg de fosfato de sodio dibásico, anhidro, USP; 93 mg de fosfato de sodio monobásico, monohidratado, USP; 318 mg de citrato de sodio, dihidratado, USP; 442 mg de acetato de sodio, trihidratado, USP; 452 mg de cloruro de sodio, USP; agua para inyección, USP, en cantidad suficiente. NO PARA INFUSIÓN INTRAVENOSA DIRECTA. Fabricado para Fresenius Kabi AG 61346 Bad Homburg / Germany Tel.: +49 (0) 61 72 / 686-0 Fabricado por Fenwal International Inc. Road 357 K.M. 0.8 Maricao, Puerto Rico 00606 Made in US Importado y Distribuido por: Uruguay BIOERIX SA Simón Bolívar 1472- Tel/Fax 27081624 Dirección Técnica: Q.F. Mariela Ricca Importado y distribuido por: Fresenius Kabi México S.A. de C.V. Av. Paseo del Norte No. 5300-A, Colonia San Juan de Ocotán, C.P. 45010, Zapopan, Jalisco, México Reg. No.: 0459C2021 SSA Importado y distribuido por: Fresenius Kabi Colombia S.A.S. Avenida Carrera 7° No. 155c-20 Piso 40 Bogotá, Colombia Phone: +57 (1) 7 56 04 04 Reg. San. No. INVIMA 2021DM-0006825-R1 47-17-11-646 REV: A L6B7850 NDC No. 0942-9603-12 Rx Only 500 mL InterSol Solution Platelet Additive Solution 3 For use with the AMICUS separator only. Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. Discard unused portion. Each 100 mL contains 305 mg Dibasic Sodium Phosphate, Anhydrous, USP; 93 mg Monobasic Sodium Phosphate, Monohydrate, USP; 318 mg Sodium Citrate, Dihydrate, USP; 442 mg Sodium Acetate, Trihydrate, USP; 452 mg Sodium Chloride, USP; Water for Injection, USP quantity sufficient. NOT FOR DIRECT INTRAVENOUS INFUSION. Manufacturer Fresenius Kabi AG 61346 Bad Homburg / Germany Tel.: +49 (0) 61 72 / 686-0 Manufacturing facility/ Manufacture by Fenwal International Inc. Road 357 K.M. 0.8 Maricao, Puerto Rico 00606 Made in US Imported and distributed by: Uruguay BIOERIX SA Simón Bolívar 1472- Tel/Fax 27081624 Dirección Técnica: Q.F. Mariela Ricca Imported and distributed by: Fresenius Kabi México S.A. de C.V. Av. Paseo del Norte No. 5300-A, Colonia San Juan de Ocotán, C.P. 45010, Zapopan, Jalisco, México Reg. No.: 0459C2021 SSA Imported and distributed by: Fresenius Kabi Colombia S.A.S. Avenida Carrera 7° No. 155c-20 Piso 40 Bogotá, Colombia Phone: +57 (1) 7 56 04 04 Reg. San. No. INVIMA 2021DM-0006825-R1 47-17-11-646 REV: A spanish pack label symbols esprimmfg1 esprimmfg2 primlabsym1 mfg1 mfg2 spanish label image
- How Supplied/Storage and Handling : 500 mL sterile solution in a non-PVC plastic container with a sterile, non-pyrogenic fluid path. The InterSol solution container is supplied in a vented plastic overwrap covering that serves as a dust cover for the container. The dust cover is not a sterility barrier and is not an element that defines the expiration date of the InterSol product. © 2021 Fresenius Kabi AG. All rights reserved. Fresenius Kabi AG 61346 Bad Homburg / Germany Tel.: +49 (0) 61 72 / 686-0 www.fresenius-kabi.com ensymbols
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL L6B7850 NDC No. 0942-9603-12 Solamente Rx 500 mL Solución InterSol Solución aditiva para plaquetas 3 Para ser usada exclusivamente con el separador AMICUS. Almacenar a temperatura ambiente controlada. Proteger de la congelación. Evitar el calor excesivo. Deseche la porción no utilizada. Cada 100 mL contienen 305 mg de fosfato de sodio dibásico, anhidro, USP; 93 mg de fosfato de sodio monobásico, monohidratado, USP; 318 mg de citrato de sodio, dihidratado, USP; 442 mg de acetato de sodio, trihidratado, USP; 452 mg de cloruro de sodio, USP; agua para inyección, USP, en cantidad suficiente. NO PARA INFUSIÓN INTRAVENOSA DIRECTA. Fabricado para Fresenius Kabi AG 61346 Bad Homburg / Germany Tel.: +49 (0) 61 72 / 686-0 Fabricado por Fenwal International Inc. Road 357 K.M. 0.8 Maricao, Puerto Rico 00606 Made in US Importado y Distribuido por: Uruguay BIOERIX SA Simón Bolívar 1472- Tel/Fax 27081624 Dirección Técnica: Q.F. Mariela Ricca Importado y distribuido por: Fresenius Kabi México S.A. de C.V. Av. Paseo del Norte No. 5300-A, Colonia San Juan de Ocotán, C.P. 45010, Zapopan, Jalisco, México Reg. No.: 0459C2021 SSA Importado y distribuido por: Fresenius Kabi Colombia S.A.S. Avenida Carrera 7° No. 155c-20 Piso 40 Bogotá, Colombia Phone: +57 (1) 7 56 04 04 Reg. San. No. INVIMA 2021DM-0006825-R1 47-17-11-646 REV: A L6B7850 NDC No. 0942-9603-12 Rx Only 500 mL InterSol Solution Platelet Additive Solution 3 For use with the AMICUS separator only. Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. Discard unused portion. Each 100 mL contains 305 mg Dibasic Sodium Phosphate, Anhydrous, USP; 93 mg Monobasic Sodium Phosphate, Monohydrate, USP; 318 mg Sodium Citrate, Dihydrate, USP; 442 mg Sodium Acetate, Trihydrate, USP; 452 mg Sodium Chloride, USP; Water for Injection, USP quantity sufficient. NOT FOR DIRECT INTRAVENOUS INFUSION. Manufacturer Fresenius Kabi AG 61346 Bad Homburg / Germany Tel.: +49 (0) 61 72 / 686-0 Manufacturing facility/ Manufacture by Fenwal International Inc. Road 357 K.M. 0.8 Maricao, Puerto Rico 00606 Made in US Imported and distributed by: Uruguay BIOERIX SA Simón Bolívar 1472- Tel/Fax 27081624 Dirección Técnica: Q.F. Mariela Ricca Imported and distributed by: Fresenius Kabi México S.A. de C.V. Av. Paseo del Norte No. 5300-A, Colonia San Juan de Ocotán, C.P. 45010, Zapopan, Jalisco, México Reg. No.: 0459C2021 SSA Imported and distributed by: Fresenius Kabi Colombia S.A.S. Avenida Carrera 7° No. 155c-20 Piso 40 Bogotá, Colombia Phone: +57 (1) 7 56 04 04 Reg. San. No. INVIMA 2021DM-0006825-R1 47-17-11-646 REV: A spanish pack label symbols esprimmfg1 esprimmfg2 primlabsym1 mfg1 mfg2 spanish label image
Overview
InterSol solution is an isotonic solution designed to replace a proportion of the plasma used in the storage of platelets. The solution contains constituents that are naturally occurring components present in many cellular systems: sodium acetate as a nutrient, sodium citrate to prevent platelet clumping and activation, sodium phosphate for buffering and sodium chloride for osmolarity. InterSol solution does not have a pharmacological effect in vivo, but rather acts to provide the appropriate environment and nutrients in lieu of a portion of the plasma normally used for the storage of platelets.
Indications & Usage
Rx only For use with the AMICUS Separator only . Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. Definition of "Controlled Room Temperature": "A temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15°C and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40°C are permitted as long as they do not exceed 24 hours ... The mean kinetic temperature is a calculated value that may be used as an isothermal storage temperature that simulates the non isothermal effects of storage temperature variations." Reference: United States Pharmacopeia, General Notices. United States Pharmacopeial Convention, Inc. 12601 Twinbrook Parkway, Rockville, MD. Dispose of waste in appropriate biohazard container or according to local regulatory requirements. Indications and Usage: InterSol solution is an isotonic solution designed to replace a proportion of the plasma used in the storage of AMICUS™-derived leukoreduced apheresis platelets under standard blood banking conditions. There is no direct therapeutic effect to be expected from the formulation. The solution should never be infused directly into a patient. InterSol platelets are leukocyte-reduced apheresis platelet concentrates that are stored in a mix of 65% InterSol and 35% plasma, nominal. InterSol platelets prepared within the range of Table 1 may be stored for up to 5 days at 20-24°C, with continuous agitation. table1
Dosage & Administration
: InterSol solution may only be used with the AMICUS Separator System using an AMICUS Apheresis Kit with a Platelet Additive Solution (PAS) Connector. For full instructions on the use of InterSol solution with the AMICUS separator, see the AMICUS Operator’s Manual. Prior to use of InterSol solution, check the plastic container for leaks by squeezing the bag firmly. If leaks are found, discard solution. To connect the InterSol solution to the AMICUS Apheresis Kit: 1) Close the clamp on the PAS Connector line. 2) Remove the protective cap from the membrane port on the InterSol solution container. 3) Insert the spike on the PAS Connector line into the membrane port on the InterSol solution container until firmly seated. 4) For the addition of InterSol solution to the platelet product, follow the instructions provided in the AMICUS Separator Operator’s Manual.
Warnings & Precautions
: • InterSol solution is NOT FOR DIRECT INTRAVENOUS INFUSION. • Do not use if particulate matter is present or if the solution is cloudy. • Do not use if the container is damaged, leaking or if there is any visible sign of deterioration. • Do not vent. • Do not reuse. Discard unused or partially used InterSol solution. • Protect from sharp objects. • Verify that the InterSol solution has been securely attached to the PAS Connector line to avoid disconnection and leaks.
Contraindications
: InterSol solution is added to AMICUS-derived leukoreduced platelet concentrates after the apheresis procedure is complete. It is not for direct intravenous infusion. There are no known contraindications associated with the use of InterSol solution for the preparation of InterSol platelets.
Adverse Reactions
InterSol solution is added to AMICUS-derived leukoreduced platelet concentrates after the apheresis procedure is complete. It is not for direct intravenous infusion. InterSol solution is not expected to cause adverse events other than those normally associated with platelet transfusion.
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