SOLUCION INTERSOL- solucion aditiva para plaquetas 3 solution

Solucion InterSol by

Drug Labeling and Warnings

Solucion InterSol by is a Prescription medication manufactured, distributed, or labeled by Fenwal, Inc., Fenwal International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • ADVERSE REACTIONS

    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.

  • DRUG ABUSE AND DEPENDENCE

    Drug Abuse / Dependence:
    InterSol solution is used as a storage solution for platelet concentrates and has no pharmacological effect.

  • OVERDOSAGE

    Overdosage:
    InterSol solution is used as a storage solution for platelet concentrates and it is not for direct intravenous infusion.

  • DESCRIPTION

    Description:
    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.

  • CLINICAL PHARMACOLOGY

    Clinical Pharmacology:
    InterSol solution is used as a storage solution for platelet concentrates and it is not for direct intravenous infusion. This solution has no pharmacological effect.

  • CLINICAL STUDIES

    Clinical Studies:

    In Vitro Biochemical and Functional Evaluations
    InterSol platelet concentrates (n=70) prepared using the AMICUS separator and stored for 5 days showed a median and mean pH value on Day 5 of 7.2 and 7.2 ± 0.1 (range: 6.9-7.5), respectively, with a lower non-parametric 95%/95% tolerance limit of 6.9.

    Supplemental in vitro assessments of InterSol platelets and AMICUS-derived leukoreduced platelets stored in 100% plasma are presented in Table 2.

    InterSol platelets irradiated (n=18) at either 2500 or 2800 cGray (dependent on site procedures) were compared to non-irradiated InterSol platelets. At the end of storage on Day 5 the platelet yields of the irradiated products were concentrated between 2.5 x 10^11 to 3.5 x 10^11 and included one product with a yield less than2.5 x 10^11 and two products with yields greater than 3.5 x 10^11. In vitro testing is not predictive of in vivo performance, which was not evaluated. Summary statistics are presented in Table 3.

    In Vivo Recovery and Survival in Healthy Subjects

    In vivo evaluation of InterSol platelets at Day 5 (n=33) compared to a fresh platelet control resulted in a mean percent recovery of 46.4 ± 11.9 percent and 58.0 ± 10.7 percent and mean survival of 5.7 ± 1.4 days and 8.0 ± 1.4 days, respectively. The in vivo data collected were used to calculate the upper limit of a two-sided 95% confidence interval of the mean percent recovery of the algebraic expression (0.66 x Fresh – 5 Day), and of the mean percent survival (days) of the algebraic expression (0.58 x Fresh – 5 Day). The upper bound of the two-sided 95% confidence intervals for recovery and survival on Day 5 was –4.6 and –0.6 respectively and met the requirement of less than 0.

    Post-Market Transfusion-Related Adverse Events (AE) Study

    An open label, non-randomized, retrospective medical record review study was performed in 6 centers to demonstrate that the overall rate of transfusion-related AEs in patients receiving InterSol Platelet transfusions was not more than double the rate in patients receiving apheresis platelets stored in 100% plasma (Plasma Platelets). The study categorized adverse transfusion reactions according to the definitions outlined by the Biovigilance Component of the National Healthcare Safety Network (NHSN) System. All sites that participated were required to have systems in place to observe transfusion-related AEs and to record when no transfusion-related AE was observed. An independent Clinical Events Committee (CEC) blinded to platelet type and study site adjudicated the reported events.

    Patients were prescribed platelet transfusions per each site’s standard practice. The type of platelet unit the patient received was based on the site’s inventory at the time the transfusion was ordered. Site personnel observed the platelet transfusion recipient following their standard procedures. Signs and symptoms of a potential transfusion-related reaction were noted using existing reporting systems. A total of 14,005 transfusions from 6 study sites were included in the final analysis. A total of 4,160 InterSol Platelet transfusions were given to a total of 1,444 patients, and 9,845 Plasma Platelet transfusions were given to 2,202 patients. There were 165 CEC-adjudicated adverse reactions reported. Of those, 23 events were associated with InterSol Platelets and 142 events were associated with Plasma Platelets.

    Overall, 1.13% of all transfusions resulted in an AE. The percentage of InterSol Platelet transfusions which led to AEs was 0.55%, while 1.37% of Plasma Platelet transfusions resulted in AEs. The 97.5% upper confidence limit for the relative risk of transfusion-related AE associated with InterSol Platelets relative to Plasma Platelets was 0.66, indicating that the study objective of ruling out a doubling of transfusion-related AEs for InterSol vs. Plasma Platelets was met.

    The majority of the 165 CEC-adjudicated reactions were Allergic (n=93) or Febrile Non-Hemolytic Transfusions Reactions (FNHTR, n=56), at 0.66% and 0.40% of total transfusions, respectively. There were allergic reactions associated with 0.29% of InterSol Platelet transfusions and 0.82% of Plasma Platelet transfusions. FNHTR events were associated with 0.17% of InterSol Platelet transfusions and 0.50% of Plasma Platelet transfusions.

    No InterSol Platelet transfusion was associated with more than one reaction. Seven (7) Plasma Platelet transfusions (0.07% of total transfusions) were associated with two separate adverse reactions each. Two (2) InterSol Platelet and five (5) Plasma Platelet adverse reactions were classified as severe. All other reactions were classified as non-severe. All adverse reactions were reported with an outcome of “Minor or No Sequelae”.

    No adverse safety trends were identified after review of all the AEs by the independent Clinical Events Committee.
    table2 table3

  • HOW SUPPLIED

    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.

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    © 2019 Fresenius Kabi AG. All rights reserved.

     
    Fresenius Kabi AG
    61346 Bad Homburg / Germany
    Tel.: +49 (0) 61 72 / 686-0
    www.fresenius-kabi.com
     

  • 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.
    eslabelsym1




    esprimmfg1
    Fabricado para
    Fresenius Kabi AG
    61346 Bad Homburg / Germany
    Tel.: +49 (0) 61 72 / 686-0



    esprimmfg2

    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.: [Pending Number]


    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.
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    Manufacturer
    Fresenius Kabi AG
    61346 Bad Homburg / Germany
    Tel.: +49 (0) 61 72 / 686-0 



    mfg2

    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.: [Pending Number]



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  • INGREDIENTS AND APPEARANCE
    SOLUCION INTERSOL 
    solucion aditiva para plaquetas 3 solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0942-9603
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Chloride (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) Sodium Chloride452 mg  in 100 mL
    SODIUM ACETATE (UNII: 4550K0SC9B) (ACETATE ION - UNII:569DQM74SC) SODIUM ACETATE442 mg  in 100 mL
    Trisodium Citrate Dihydrate (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid318 mg  in 100 mL
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC305 mg  in 100 mL
    Sodium Phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR) Sodium Phosphate, Monobasic, Monohydrate93 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0942-9603-12500 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN08004110/25/2012
    Labeler - Fenwal, Inc. (794519020)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fenwal International, Inc.091164590MANUFACTURE(0942-9603)

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