Dianeal Low Calcium peritoneal dialysis solutions in Ambu-Flex III containers are available in nominal size flexible containers with fill volumes as indicated in Table 1. All Dianeal Low Calcium 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 overpouch 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. The opacity will diminish gradually. 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.
- Prepare medication site.
- Using a syringe with a 1 inch long 19 to 25 gauge needle, puncture resealable medication port and inject.
- Position container with ports up and evacuate the medication port by squeezing and tapping it.
- Mix solution and medication thoroughly.
Preparation for Administration
- Place container on table or suspend from support (depending on technique).
- Remove protector from outlet port of container. If a continuous fluid flow is noted, discard container.
- Attach appropriate solution transfer set to container. Refer to complete directions in hardware manual and/or directions accompanying transfer set.
- If the container has not been suspended, suspend at this time.
Discard unused portion. Table 1
Composition/100 mL OSMOLARITY (mOsmol/L) (calc) pH Ionic Concentration (mEq/L) How Supplied *Dextrose, Hydrous, USP Sodium Chloride, USP (NaCl) Sodium Lactate (C 3H5NaO3) Calcium Chloride, USP (CaCl2•2H2O) Magnesium Chloride, USP (MgCl2•6H2O) Sodium Calcium Magnesium Chloride Lactate Fill Volume (mL) Container Size (mL) Code NDC Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose 1.52g 538mg 448mg 18.3mg 5.08mg 344 5.2(4.0 to 6.5) 132 2.5 0.5 95 40 1500 2000 5B9715 0941-0409-45 2000 2000 5B4825 0941-0409-36 2500 3000 5B9718 0941-0409-48 3000 3000 5B9901 0941-0409-49 5000 5000 5B4826 0941-0409-27 6000 6000 5B9770 0941-0409-28 Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 2.52g 538mg 448mg 18.3mg 5.08mg 395 5.2(4.0 to 6.5) 132 2.5 0.5 95 40 1500 2000 5B9725 0941-0457-45 2000 3000 5B9727 0941-0457-47 2500 3000 5B9728 0941-0457-48 3000 3000 5B9902 0941-0457-49 5000 5000 5B5202 0941-0457-25 6000 6000 5B9771 0941-0457-28 Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 3.5% Dextrose 3.52g 538mg 448mg 18.3mg 5.08mg 445 5.2(4.0 to 6.5) 132 2.5 0.5 95 40 2500 3000 5B9738 0941-0463-48 Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose 4.25g 538mg 448mg 18.3mg 5.08mg 483 5.2(4.0 to 6.5) 132 2.5 0.5 95 40 1500 2000 5B9745 0941-0459-45 2000 3000 5B9747 0941-0459-47 2500 3000 5B9748 0941-0459-48 3000 3000 5B9903 0941-0459-49 5000 5000 5B5203 0941-0459-25 6000 6000 5B9772 0941-0459-28 REFERENCES Diaz-Buxo, J.A. et al. 1981. Continuous cyclic peritoneal dialysis: a preliminary report. Int Soc Artif Organs 81:157-161. Diaz-Buxo, J.A. et al. 1983. Observations on inadequate base buffer concentrations in peritoneal dialysis solutions. ASAIO Abstracts 43. Furman, K.I. et al. 1978. Activity of intraperitoneal heparin during peritoneal dialysis. Clin Nephrol 9:15-18. Gross, M. and McDonald, Jr., H.P. 1967. Effect of dialysate temperature and flow rate on peritoneal clearance. JAMA202:363-365. 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. La Greca, G. et al. 1980. Acid base balance on peritoneal dialysis. Clinical Nephrology16(1):1-6. 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. Nolph, K.D. et al. 1981. Considerations for dialysis solution modifications. In Peritoneal Dialysis,eds. Robert C. Atkins et al. Chapter 25. New York: Churchill Livingston. 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. Slatopolsky, E. et al. 1986. Calcium carbonate as a phosphate binder in patients with chronic renal failure undergoing dialysis. NEJM3:315, 157-160. 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. Vaamonde, C.A. and Perez, G.O. 1977. Peritoneal dialysis today. Kidney 10:31-36. Baxter Healthcare Corporation, Deerfield, IL 60015 USA. 2004/05. FDA rev date: 8/8/2006 Last reviewed on RxList: 11/14/2008
This monograph has been modified to include the generic and brand name in many instances.