INTERSOL- platelet additive 3 solution
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
20-10-2020
Send request.
Active ingredient:
Sodium Chloride (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698), SODIUM ACETATE (UNII: 4550K0SC9B) (ACETATE ION - UNII:569DQM74SC), Trisodium Citrate Dihydrate (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL), SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR), Sodium Phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR)
Available from:
Fenwal, Inc.
Administration route:
INTRAVENOUS
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
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 biohaza
Product summary:
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 AG 61346 Bad Homburg / Germany Tel.: +49 (0) 61 72 / 686-0 www.fresenius-kabi.com
Authorization status:
New Drug Application
Summary of Product characteristics
INTERSOL - PLATELET ADDITIVE 3 SOLUTION
FENWAL, INC.
----------
DIRECTION INSERT
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
Read the complete document
