InterSol
Platelet Additive 3 · Solution · Intravenous
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
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
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
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.
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.
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.
How supplied
How Supplied/Storage and Handling : 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
Label text from the FDA structured product label by Fenwal, Inc. (revised Jun 27, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Sodium Chloride in 3 products
- Sodium Acetate in 3 products
- Trisodium Citrate Dihydrate in 3 products
- Sodium Phosphate, Monobasic, Monohydrate in 3 products
- Sodium Phosphate, Dibasic, Unspecified Form in 2 products
- Sodium Phosphate, Dibasic in 1 product
InterSol NDC products (3)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0942-9601 | Sodium Chloride 452 mg/100mL; Sodium Acetate 442 mg/100mL; Trisodium Citrate Dihydrate 318 mg/100mL; Sodium Phosphate,… Solution | Fenwal, Inc. | NDA |
| 0942-9602 | Sodium Chloride 452 mg/100mL; Sodium Acetate 442 mg/100mL; Trisodium Citrate Dihydrate 318 mg/100mL; Sodium Phosphate,… Solution | Fenwal, Inc. | NDA |
| 0942-9605 | Sodium Chloride 452 mg/100mL; Sodium Acetate 442 mg/100mL; Trisodium Citrate Dihydrate 318 mg/100mL; Sodium Phosphate,… Solution | Fenwal, Inc. | NDA |
Frequently asked questions
What is InterSol used for?
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…
What are the side effects of InterSol?
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. See the full label for the complete list.
Who makes InterSol?
InterSol is listed by 1 labeler in the FDA NDC directory, including Fenwal, Inc..