NDC 0942-9602 Intersol

Platelet Additive 3

NDC Product Code 0942-9602

NDC Product Information

Intersol with NDC 0942-9602 is a a human prescription drug product labeled by Fenwal, Inc.. The generic name of Intersol is platelet additive 3. The product's dosage form is solution and is administered via intravenous form.

Labeler Name: Fenwal, Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Intersol Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SODIUM CHLORIDE 452 mg/100mL
  • SODIUM ACETATE 442 mg/100mL
  • TRISODIUM CITRATE DIHYDRATE 318 mg/100mL
  • SODIUM PHOSPHATE, DIBASIC 305 mg/100mL
  • SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 93 mg/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Acidifying Activity - [MoA] (Mechanism of Action)
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Anti-coagulant - [EPC] (Established Pharmacologic Class)
  • Decreased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Calcium Chelating Activity - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Fenwal, Inc.
Labeler Code: 0942
FDA Application Number: BN080041 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-05-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Intersol Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Indications & Usage

Rx onlyStore 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 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 ranges described in the apheresis system Operator's Manuals may be stored for up to 5 days at 20-24°C, with continuous agitation.

Dosage & Administration

Dosage and Administration: InterSol solution is to be used with the AMICUS Separator System or the TRIMA ACCEL system. For full instructions on the use of InterSol solution, see the Operator's Manual for the respective platelet collection system.

Dosage Forms & Strengths

Dosage Forms and Strengths:InterSol solution is provided as a 500 mL sterile and non-pyrogenic solution in a non-PVC plastic container with a sterile and non-pyrogenic fluid path. 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.

Contraindications

Contraindications: InterSol solution is added to apheresis-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.

Warnings And Precautions

  • Warnings and 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.

Adverse Reactions

Adverse Reactions: InterSol solution is added to 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 AMICUS-derived, leukoreduced platelets 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 1011 to 3.5 x 1011 and included one product with a yield less than2.5 x 1011 and two products with yields greater than 3.5 x 1011. 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 AMICUS-derived, leukoreduced plateletsIn 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  AMICUS-derived, leukoreduced plateletsAn 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 (2) 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.In Vitro Biochemical and Functional Evaluations, TRIMA ACCEL-derived, leukoreduced plateletsInterSol platelet concentrates (n = 60) prepared using the Trima Apheresis system and stored for 5 days showed a mean pH value on Day 5 of 7.2 ± 0.1 (range 7.0 – 7.3), with a lower one-sided 95% confidence interval of 0.951. Supplemental in vitro assessments of TRIMA ACCEL-derived leukoreduced platelets stored in InterSol platelet and 100% plasma are presented in Table 3.In Vivo Recovery and Survival in Healthy Subjects, TRIMA ACCEL-derived, leukoreduced plateletsIn vivo evaluations of TRIMA ACCEL-derived platelets stored in InterSol at Day 5 (n = 24) compared to fresh platelet control resulted in a mean percent recovery of 45.2 ± 12.3 percent and 56.0 ± 13.2 percent and a mean survival of 5.4 ± 1.0 days and 7.9 ± 1.5 days, respectively. The in vivo data collected were used to calculate the upper limit of a one-sided 97.5% confidence interval of the mean percent recovery of the algebraic expression of (0.66 x Fresh – 5 Day) and the mean percent survival (days) of the algebraic expression (0.58 x Fresh – 5 Day). The lower limit of the one-sided 97.5% confidence intervals for recovery and survival on Day 5 was 4.0 and 0.4 respectively and met the requirement of greater than 0.

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.TRIMA ACCEL is a trademarks of Terumo BCT, Inc. © 2018 Fresenius Kabi AG. All rights reserved. Fresenius Kabi AG61346 Bad Homburg / Germany Tel.: +49 (0) 61 72 / 686-0 www.fresenius-kabi.com

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