ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) by is a Prescription medication manufactured, distributed, or labeled by Fenwal, Inc., Fenwal International. Drug facts, warnings, and ingredients follow.
Sólamente Rx
Antes de continuar, identifique la unidad BOLSANG™ utilizando el sistema de identificación de donante adecuado.
NOTAS:
PRECAUCIONES A TOMARSE
Superficie interior estéril y libre de pirógenos. Esterilización por vapor. Utilice sólo una vez. No ventilar. Deseche el envase según corresponda.
Almacenar a temperatura ambiente controlada.
Farmacopea de los Estados Unidos. “Avisos Generales” United States
Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD
Rx only
Before proceeding further, identify BLOOD-PACK™ unit using appropriate donor identification system.
NOTES:
CAUTIONS TO BE TAKEN
Sterile, non-pyrogenic fluid path. Steam sterilized.
Single use only. Do not vent.
Dispose of container appropriately.
Store at Controlled Room Temperature. USP Definition of “Controlled Room Temperature” United States Pharmacopeia, General Notices.
United States Pharmacopeial Convention, Inc.
12601 Twinbrook Parkway, Rockville, MD
– Fabricante/Manufacturer
Fabricado por/Manufactured by:
Fenwal International, Inc.
Road 357, Km. 0.8
Maricao, PR 00606
Hecho en EE. UU. / Made in USA
Importado y distribuido en India por:/
Imported and distributed in India by:
Fenwal India Pvt Ltd
Upper Ground Floor, Tower B
DLF Building No. 10, DLF Cyber City
DLF Phase II, Gurgaon 122 002,
Haryana, India
Import License No.: FF-504-14890
Importado y distribuido en Indonesia por:/
Imported and distributed in Indonesia by:
PT. Medquest Jaya Global
Menara Salemba 6th Floor
Jl.Salemba Raya Kav 5-5A
Jakarta-Indonesia 10440
Reg. No.: DEPKES RI AKL 20209902358
Importado y distribuido en Thailand por:/
Imported and distributed in Thailand by:
Fenwal (Thailand) Ltd.
17th Fl. Thanapoom Tower
1550 New Petchburi Rd., Makasan
Rajthevi, Bangkok 10400
Thailand
Reg. No.:
Importado y distribuido en Perú por:/
Imported and distributed in Perú by:
HERSIL S.A. LABORATORIOS INDUSTRIALES FARMACÉUTICOS
Av. Los Frutales No. 220
Ate, Lima 3 –Perú
RUC: 20100060150
Q.F. Responsable: Antonio Benitez Z.
Reg. No.:
Importado y distribuido en Venezuela por:/
Imported and distributed in Venezuela by:
SOLUCARE GT, C.A. RIF J-30512494-9
en La Urbina, Caracas,
Republica Bolivariana de Venezuela
TELF (0212) 2436663
Importado y distribuido en Colombia por:/
Imported and distributed in Colombia by:
Fenwal Colombia Ltda.
Centroempresa, Cali, Colombia
Reg. No.: INVIMA-2006M-0000140-R1
07-19-04-576 REV: A 03/2010
FENWAL, BOLSANG, ADSOL, TRANSFER PACK, OPTIPRESS y OPTIPAC son Marcas Registradas de Fenwal, Inc.
FENWAL, BLOOD-PACK, ADSOL, TRANSFER PACK, OPTIPRESS and OPTIPAC are trademarks of Fenwal, Inc.
DONORCARE is a trademark of ITL Corporation.
DONORCARE es una marca comercial de ITL Corporación.
© 2010 Fenwal, Inc. Todos los derechos reservados. All rights reserved.
R4R7794
4 Units
Fenwal™
QUADRUPLE BLOOD-PACK™ OPTIPAC™ UNIT, CPD/ADSOL™
PL 146
PL 1240
Plastic
Rx Only
Quadruple BLOOD-PACK™ OPTIPAC™ unit consisting of a primary pack containing 63 mL of CPD anticoagulant solution for collection of 450 mL of blood, one TRANSFER PACK™ containing 100 mL of ADSOL™ solution and two TRANSFER PACK™ containers without solution. 16 gauge needle.
See instructions for use. Sterile, non-pyrogenic fluid path. Steam sterilized. Single use only. Do not vent. Do not use if there is any visible evidence of deterioration. Dispose of container appropriately.
Store at Controlled Room Temperature (refer to direction insert).
Unused packs in open foil pouch may be kept 60 days by folding and securing open end of foil pouch, to prevent possible loss of moisture.
Direct handling of product surfaces prior to extended storage in the foil pouch may result in mold growth.
Units removed from the foil pouch must be used within 4 days (96 hours). Units out of the foil pouch for longer than 4 days must be discarded.
Each 63 mL of CPD solution contains: 1.66 g, Sodium citrate (dihydrate), USP, 1.61 g, Dextrose (monohydrate), USP, 188 mg, Citric acid (anhydrous), USP, 140 mg Monobasic sodium phosphate (monohydrate), USP. Water for Injection USP to 63 mL.
Each 100 mL of ADSOL solution contains: Sodium chloride, USP, 900 mg, Dextrose monohydrate, USP, 2.20 g, Adenine, USP, 27.0 mg, Mannitol, USP, 750 mg. Water for Injection USP to 100 mL.
Manufactured by:
Fenwal International, Inc.
Road 357, Km. 0.8
Maricao, PR 00606
Made in USA
FENWAL, ADSOL, OPTIPAC, TRANSFER PACK and BLOOD-PACK are trademarks of Fenwal, Inc.
07-28-04-571 REV: A
Imported and distributed in India by:
Fenwal India Pvt Ltd
Upper Ground Floor, Tower B
DLF Building No. 10
DLF Cyber City, DLF Phase-II, Gurgaon 122 002
Haryana, India
Import License No.: FF-504-14890
MRP Rs.: 850 (Inclusive of all taxes)
Lot No.:
Exp.:
ADSOL RED CELL PRESERVATION SOLUTION SYSTEM IN PLASTIC CONTAINER (PL 146 PLASTIC)
anticoagulant citrate phosphate dextrose (cpd) solution and adsol preservation solution kit |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
Labeler - Fenwal, Inc. (794519020) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Fenwal International, Inc. | 091164590 | MANUFACTURE(0942-6494) |