InterSol

InterSol is an FDA-registered drug product whose active ingredient is PLATELET ADDITIVE 3. It is labelled by Fenwal, Inc. taken by intravenous and marketed as a human prescription drug product. Identifiers on file: NDC 0942-9601, application BN080041, label effective 20211116. It is one of 2 FDA drug label records sharing the active ingredient PLATELET ADDITIVE 3. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing PLATELET ADDITIVE 3 are most often described in connection with: mean kinetic, controlled room, temperature calculated, united states, intersol platelets, amicus separator, only store, freezing avoid. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 and 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.

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.

FDA lists 2 drug label records with PLATELET ADDITIVE 3 as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is InterSol used for?
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 …

Who makes InterSol?
Fenwal, Inc. is the labeler of record for InterSol. 2 FDA label records share the active ingredient PLATELET ADDITIVE 3, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does InterSol come in?
administered by intravenous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is InterSol prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing PLATELET ADDITIVE 3?
Yes. 2 FDA drug label records list PLATELET ADDITIVE 3 as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has InterSol been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.