ISOPLATE- sodium chloride, sodium gluconate, sodium acetate, potassium chloride, magnesium chloride, sodium phosphate, dibasic,

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM GLUCONATE (UNII: R6Q3791S76) (GLUCONIC ACID - UNII:R4R8J0Q44B, SODIUM CATION - UNII:LYR4M0NH37), SODIUM ACETATE (UNII: 4550K0SC9B) (ACETATE ION - UNII:569DQM74SC, SODIUM CATION - UNII:LYR4M0NH37), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNI

Disponible desde:

Terumo BCT Ltd.

Designación común internacional (DCI):

SODIUM CHLORIDE

Composición:

SODIUM CHLORIDE 0.53 g in 100 mL

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

ISOPLATE SOLUTION - Platelet Additive Solution [PAS-F] is an isotonic solution to replace a portion of the plasma to store Platelets Pheresis Platelet Additive Solution (PAS) Added Leukocytes Reduced products collected using a hyperconcentrated collection on Terumo BCT's Trima Accel system [See Dosage and Administration (2).] Platelets Pheresis PAS Added Leukocytes Reduced products are stored in a mix of 65% ISOPLATE SOLUTION and 35% plasma. Platelets in the solution can be stored at a concentration range of 0.7 to 2.1 × 106 /µL for up to 5 days at 20-24 °C with continuous agitation in the Terumo BCT ELP bag [citrated polyvinyl chloride (PVC)] [See Clinical Studies (14).] DO NOT INFUSE ISOPLATE SOLUTION DIRECTLY TO THE PATIENTS.

Resumen del producto:

ISOPLATE SOLUTION - Platelet Additive Solution [PAS-F] is a clear solution supplied in sterile and nonpyrogenic polyolefin bags. The ISOPLATE SOLUTION bags are packaged 18 bags per case. STORAGE Store up to 25 °C [See USP Controlled Room Temperature]. Platelets Pheresis PAS Added Leukocytes Reduced products are stored in a mix of 65% ISOPLATE SOLUTION and 35% plasma. Platelets in the solution can be stored at a concentration range of 0.7 to 2.1 × 106/µL for up to 5 days at 20-24 °C with continuous agitation in the Terumo BCT ELP bag [citrated polyvinyl chloride (PVC)].

Estado de Autorización:

New Drug Application

Ficha técnica

ISOPLATE- SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM
CHLORIDE,
MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM
PHOSPHATE, MONOBASIC SOLUTION
TERUMO BCT LTD.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ISOPLATE SOLUTION - PLATELET ADDITIVE
SOLUTION [PAS-F] SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR ISOPLATE SOLUTION - PLATELET
ADDITIVE SOLUTION [PAS-F].
ISOPLATE SOLUTION
PLATELET ADDITIVE SOLUTION [PAS-F]
STERILE FLUID
POLYOLEFIN BAG
INITIAL U.S. APPROVAL: 2013
RECENT MAJOR CHANGES
Dosage and Administration (2.2)
5/2015
INDICATIONS AND USAGE
ISOPLATE SOLUTION - Platelet Additive Solution [PAS-F] is an isotonic
solution to replace a portion of the plasma to
store Platelets Pheresis Platelet Additive Solution (PAS) Added
Leukocytes Reduced products collected using a
hyperconcentrated collection on Terumo BCT's Trima Accel system.
Platelets Pheresis PAS Added Leukocytes Reduced
products are stored in a mix of 65% Isoplate and 35% plasma.
Platelets in ISOPLATE SOLUTION can be stored at a concentration range
of 0.7 to 2.1 × 10 /µL for up to 5 days at 20-24
°C with continuous agitation in the Terumo BCT ELP bag [citrated
polyvinyl chloride (PVC)]. (1)
DOSAGE AND ADMINISTRATION
ISOPLATE SOLUTION is added to hyperconcentrated platelets after the
apheresis procedure is complete. (2)
ISOPLATE SOLUTION may only be used with the Trima Accel system. For
instructions on the use of the solution with
the Trima Accel system, see the Trima Accel system operator's manual.
(2.1)
Follow the directions for connecting the ISOPLATE SOLUTION bag to the
Trima Accel System. (2.2)
DOSAGE FORMS AND STRENGTHS
500 mL sterile fluid in polyolefin bag (3)
CONTRAINDICATIONS
DO NOT INFUSE ISOPLATE SOLUTION DIRECTLY TO THE PATIENTS. (4)
WARNINGS AND PRECAUTIONS
Verify that the ISOPLATE SOLUTION has been securely attached to the
platelet additive solution line on the Trima
Accel system tubing set using aseptic technique. (5)
ADVER