DIANEAL PD-1 peritoneal dialysis solutions in AMBU-FLEX lll containers are available in nominal size flexible containers with fill volumes and dextrose concentrations as indicated in Table 1. All DIANEAL PD-1 peritoneal dialysis solutions have overfills which are declared on container labeling. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F): brief exposure up to 40°C (104°F) does not adversely affect the product. Directions for Use Use aseptic technique. For complete system preparation, see directions accompanying ancillary equipment. Peritoneal dialysis solutions may be warmed in the overpouch to 37°C (98.6°F) to enhance patient comfort. However, only dry heat (for example, heating pad) should be used. Solutions should not be heated in water due to an increased risk of infection. Microwave ovens should not be used to heat solutions because there is a potential for damage to the solution container. Moreover, microwave oven heating may potentially cause overheating and/or non-uniform heating of the solution that may result in patient injury or discomfort. To Open Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. If supplemental medication is desired, follow directions below before preparing for administration. Check for minute leaks by squeezing container firmly. To Add Medication Additives may be incompatible. If the resealable rubber plug on the medication port is missing or partially removed, do not use product if medication is to be added. 1. Prepare medication site. 2. Using a syringe with a 1 inch long 19 to 25 gauge needle, puncture resealable medication port and inject. 3. Position container with ports up and evacuate the medication port by squeezing and tapping it. 4. Mix solution and medication thoroughly. Preparation for Administration 1. Place container on table or suspend from support (depending on technique). 2. Remove protector from >outlet port of container. 3. Attach appropriate solution transfer set. Refer to complete directions in hardware manual and/or directions accompanying transfer set. Discard unused portion. References Chang, T.M.S. 1977. Criteria, evaluation, and perspectives of various microencapsulated charcoal hemoperfusion systems. Dial and Transplant 6:50-53.
Diaz-Buxo, J.A. et al. 1981. Continuous cyclic peritoneal dialysis: a preliminary report. Int Soc Artif Organs 81:157-161.
Furman, K.l. et al. 1978. Activity of intraperitoneal heparin during peritoneal dialysis. Clin Nephrol 9:15-18.
Irwin, M.A. et al. 1981. Continuous ambulatory peritoneal dialysis in pediatrics. AANNT J 8:11-13,44.
Kim, D. et al. 1984. Continuous ambulatory peritoneal dialysis with three-liter exchanges: a prospective study. Peritoneal Dial Bull 4:82-85.
Knepshield, J.H. et al. 1977. Dialysis of poisons and drugs - update. Trans Am Soc Artif Intern Organs 23:762-842.
Mattocks, A.M. and El-Bassiouni, E.A. 1971. Peritoneal dialysis: a review. J Pharm Sci 60:1767-1782.
Moncrief, J.W. et al. 1982. CAPD: Are three exchanges per day adequate? AANNT J 9:39-43.
Popovich, R.P. et al. 1978. Continuous ambulatory peritoneal dialysis. Ann Intern Med 8:449-456.
Potter, D.E. et al. 1981. Continuous ambulatory dialysis (CAPD) in children. Trans Am Soc Artif Intern Organs 27:64-67.
Ribot, S. et al. 1966. Complications of peritoneal dialysis. Am J Med Sci 252:505-517.
Vaamonde, C.A. and Perez, G.O. 1977. Peritoneal dialysis today. Kidney 10:31-36.
Twardowski, Z.J. and Janicka, L. 1981. Three exchanges with a 2.5 liter volume for continuous ambulatory peritoneal dialysis. Kidney Int 20:281-284.
Twardowski, Z.J. et al. 1983. High volume low frequency continuous ambulatory peritoneal dialysis. Kidney Int 23:64-70.
Twardowski, Z.J. and Burrows, L. 1984. Two year experience with high volume, low frequency continuous ambulatory peritoneal dialysis. Peritoneal Dial Bull 4:S67. Baxter, DIANEAL, AMBU-FLEX, and PL 146 are trademarks of Baxter International Inc.
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Printed in USA Copyright 1981, 1982, 1983, 1984, 1989, Baxter Healthcare Corporation. All rights reserved.
FDA rev date 9/05Last reviewed on RxList: 12/25/2005
This monograph has been modified to include the generic and brand name in many instances.