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Rx

InterSol

platelet additive 3 · InterSol is a prescription drug containing platelet additive 3, made by Fenwal, Inc..

Type
Prescription
Drug class
Not classified
Route
Intravenous
Manufacturers
1

6B7800S 12x 800 mL Rx only Store at Controlled Room Temperature.

Related recalls

FDA drug recalls that name this drug or its active ingredient

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Uses

6B7800S 12x 800 mL Rx 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 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 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 and strengths

InterSol solution is provided as a 800 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

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

  • 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.

Side effects (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.

Abuse and dependence

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

Overdose

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

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.

How supplied

800 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. Fresenius Kabi AG Else-Kröner-Str. 1 61352 Bad Homburg Germany Tel.: +49 (0) 61 72 / 686-0 www.fresenius-kabi.com www.fresenius-kabi.com/us/symbolglossary For US: 1-800-933-6925 All trademarks shown are property of their respective owners. © 2025 Fresenius Kabi AG. All rights reserved. 472317814 [B] 2025/03 symbols6B7800s mf6b7800s

Forms and strengths

From the FDA NDC Directory · 3 product codes

Dosage formStrengthRouteNDCs
Solution452 mg/100mL / 442 mg/100mL / 318 mg/100mL / 305 mg/100mL / 93 mg/100mLintravenous2
Solution452 mg/100mL / 442 mg/100mL / 318 mg/100mL / 93 mg/100mL / 305 mg/100mLintravenous1

Manufacturers and labels

3 FDA labels

  • Fenwal, Inc.Shown hereBN080041 · Label 06/27/2025 · NDC 0942-9605Full label
  • Fenwal, Inc.BN080041 · Label 11/16/2021 · NDC 0942-9601Full label
  • Fenwal, Inc.BN080041 · Label 10/20/2020 · NDC 0942-9602Full label

InterSol: common questions

What is InterSol used for?
6B7800S 12x 800 mL Rx only Store at Controlled Room Temperature.
What are the side effects of InterSol?
InterSol solution is added to leukoreduced platelet concentrates after the apheresis procedure is complete. See the full side effects section on this page, and ask your doctor or pharmacist about any side effect that bothers you.
Is InterSol a prescription drug?
Yes. InterSol is a prescription (Rx) drug.
Who makes InterSol?
Fenwal, Inc. lists InterSol with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 06/27/2025 · Label text is shown as published by the manufacturer. Not medical advice

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