Drugplain

Solucion InterSol 442 mg/100mL

Solucion aditiva para plaquetas 3 · SOLUTION · Fenwal, Inc.

No Recall History
Plain English

Solucion Intersol is an additive solution used to help preserve and maintain platelets during storage for transfusion purposes. It is administered intravenously as part of blood bank procedures to extend the shelf life of platelet products.

Key Facts

Brand Name
Solucion InterSol
Generic Name
Solucion aditiva para plaquetas 3
NDC Code (Product)
0942-9603
Manufacturer
Fenwal, Inc.
Strength
442 mg/100mL
Dosage Form
SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
BN080041
Marketing Start
10/25/2012

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 t

Dosage & Administration

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

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

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.

Frequently Asked Questions

What is Solucion InterSol used for?

Solucion Intersol is an additive solution used to help preserve and maintain platelets during storage for transfusion purposes. It is administered intravenously as part of blood bank procedures to extend the shelf life of platelet products.

Is Solucion InterSol a controlled substance?

Solucion InterSol is not classified as a controlled substance by the DEA.

What is the generic name for Solucion InterSol?

The generic name for Solucion InterSol is Solucion aditiva para plaquetas 3. There are no other listed brand versions of Solucion aditiva para plaquetas 3.

What is the NDC code for Solucion InterSol 442 mg/100mL?

The NDC (National Drug Code) for Solucion InterSol 442 mg/100mL is 0942-9603, listed by Fenwal, Inc..

Product NDC

0942-9603

Package NDC

0942-9603-12

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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