The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Instructions For Blood Collection Using Cpd Optipac™ Unit With An Integrally Attached Container Of Adsol™ Red Cell Preservation Solution
- Rx Only Opti-SystemUse aseptic techniqueCaution: Do not use unless the solutions are clear.1.Identify BLOOD-PACK™ OPTIPAC™ unit using appropriate donor identification system.2.Adjust donor scale to desired collection weight/volume.3.Suspend primary container from donor scale as far as possible below donor arm and clamp donor tubing with hemostat.4.Apply pressure to donor’s arm and disinfect site of venipuncture.5.If blood pressure cuff is used, inflate to approximately 60 mm Hg, or use tourniquet as applicable.6.Remove needle cover per instructions below:a)Hold the needle hub upwards. With the other hand, grasp the base of the needle cover (Figure 1), twist approximately 1/4 turn to break tamper evident seal (Figure 2).b)Remove needle cover (Figure 3), be careful not to drag cover across the needle point (Figure 4).7.Perform venipuncture, appropriately secure donor needle and/or tubing and release hemostat.8.Mix blood and anticoagulant at several intervals during collection and immediately after collection.9.Collect labeled volume of blood. Anticoagulant volume is sufficient for labeled volume ± 10%.10.Apply hemostat to donor tubing.11.If it is necessary, obtain whole anticoagulated blood samples for typing or crossmatching by returning donor tubing blood to the primary bag, mixing and allowing tubing to refill. Repeat once. Seal donor tubing at the desired intervals in order to obtain the desired total blood samples.12.Centrifuge primary and secondary bags in order to prepare CPD Red Blood Cells.13.Refer to the OPTIPRESS™ Blood Components Automated Extractor User Manual, in order to prepare the components.14.After separation, seal transfer tubing in three places near the primary bag and cut middle seal taking care to avoid fluid splatter.NOTE: In OPTIPAC Quadruple BLOOD-PACK unit, the empty transfer unit may be used for preparation of other components.15.Fill empty tubing of OPTIPAC AS-1 for red blood cells by stripping the tubing and mixing the AS-1 containter, twice, in order to ensure that the tubing is correctly filled. Seal on "X" marks on tubing in order to obtain red blood cells samples.16.Mix Adsol Solution and red cells thoroughly.17.Store suspended Red Blood Cells between 1 and 6 °C.For further processing, use standard techniques for component processing.Sterile, non-pyrogenic fluid path. Sterilized by steam. Single use only. Dispose of container appropriately.Store at Controlled Room TemperatureUSP Definition of “Controlled Room Temperature”United States Pharmacopeia, General Notices.United States Pharmacopeial Convention, Inc.12601 Twinbrook Parkway, Rockville, MDManufactured by:Fenwal International, Inc.Road 357, Km. 0.8Maricao, PR 00606Made in USA07-19-05-015 REV: A07/2010Imported and distributed in Indonesia by:PT.Medquest Jaya GlobalMenara Salemba 6th FloorJl.Salemba Raya Kav 5-5AJakarta-Indonesia 10440Reg. No.: DEPKES RI AKL 20209902359Imported and distributed in Thailand by:Fenwal (Thailand) Ltd.17th Fl. Thanapoom Tower1550 New Petchburi Rd., MakasanRajthevi, Bangkok 10400ThailandReg. No.:Imported and distributed in Philippines by:Medlink MarketingUnit 404 Vicar’s Building,No.31 Visayas Ave.,Vasra, Quezon City 1100PhilippinesReg. No.: DVR-5805– ManufacturerFENWAL, ADSOL, BLOOD-PACK, OPTIPAC and OPTIPRESS are trademarks of Fenwal, Inc.© 2010 Fenwal, Inc. All rights reserved.
Package/Label Display Panel
Code: A4R7473 3 UnitsFenwal™CPD/ADSOL™ BLOOD-PACK™ Unit Quadruple OPTIPAC™ Opti-SystemRx onlyEach unit consists of a PL 146 bag containing 63 mL of Citrate, Phosphate and Dextrose Anticoagulant Solution (CPD) with 450 mL of capacity; a PL 146 transfer pack containing 100 mL of Adenine, Dextrose and Mannitol Solution (ADSOL), 450 mL of capacity; and two PL 1240 transfer packs, 400 mL of capacity.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 contain: 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.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 sign of deterioration. Dispose of container appropriately.Store at Controlled Room Temperature (refer to direction insert).Unused units in open foil pouch may be kept up to 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.Manufactured by:Fenwal International, Inc.Road 357, Km. 0.8Maricao, PR 00606Made In USAImported and distributed in Philippines by:Medlink MarketingUnit 404 Vicar’s Building,No.31 Visayas Ave.,Vasra, Quezon City 1100PhilippinesReg No.: DVR-5805Imported and distributed in Indonesia by:PT.Medquest Jaya GlobalMenara Salemba 6th FloorJl.Salemba Raya Kav 5-5AJakarta-Indonesia 10440Reg No.: DEPKES RI AKL 20209902359FENWAL, BLOOD-PACK, OPTIPAC and ADSOL are trademarks of Fenwal, Inc.07-28-05-041 REV: ALot:Exp. Date:
* Please review the disclaimer below.