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Dianeal PD2

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Dianeal PD-2

DIANEAL PD-2
(peritoneal dialysis solution
AMBU-FLEX Container For Peritoneal Dialysis

For intraperitoneal administration only

DRUG DESCRIPTION

DIANEAL PD-2 peritoneal dialysis solutions in AMBU-FLEX containers are sterile, nonpyrogenic solutions for intraperitoneal administration only. They contain no bacteriostatic or antimicrobial agents or added buffers.

D-Glucopyranose monohydrate structural formula illustration

Dextrose Hydrous, USP (D-Glucopyranose monohydrate)

Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 1.

Table 1.

  Composition/100 mL Osmolarity
(mOsmol/L) (calc)
pH Ionic Concentration
(mEq/L)
How Supplied
Sodium Calcium Magnesium Chloride Lactate Fill Volume (mL) Container Size (mL) Code NDC
*Dextrose, Hydrous, USP Sodium Chloride, USP
(NaCl)
Sodium Lactate
(C3H5 NaO3)
Calcium Chloride, USP
(CaCl2•2H2O)
Magnesium Chloride, USP
(MgCl2•6H2O)
Dianeal® PD-2 Peritoneal Dialysis 1.5% Dextrose AMBU-FLEX II CONTAINER 1.5 g 538 mg 448 mg 25.7 mg 5.08 mg 346 5.2
(4.0 to 6.5)
132 3.5 0.5 96 40 1000 1000 L5B5163 NDC 0941-0411-05
2000 3000 L5B5166 NDC 0941-0411-06
2500 3000 L5B5168 NDC 0941-0411-08
3000 3000 L5B5169 NDC 0941-0411-04
5000 6000 L5B5193 NDC 0941-0411-07
6000 6000 L5B9710 NDC 0941-0411-11
Dianeal® PD-2 Peritoneal Dialysis 1.5% Dextrose AMBU-FLEX III CONTAINER 1.5 g 538 mg 448 mg 25.7 mg 5.08 mg 346 5.2
(4.0 to 6.5)
132 3.5 0.5 96 40 250 500 5B5160 NDC 0941-0411-40
500 1000 5B5161 NDC 0941-0411-41
750 1000 5B5162 NDC 0941-0411-42
1000 1000 5B5163 NDC 0941-0411-43
1500 2000 5B5165 NDC 0941-0411-45
2000 2000 5B5166 NDC 0941-0411-46
2500 3000 5B5168 NDC 0941-0411-48
3000 3000 5B5169 NDC 0941-0411-49
5000 5000 5B5193 NDC 0941-0411-25
6000 6000 5B9710 NDC 0941-0411-28
Dianeal® PD-2 Peritoneal Dialysis 2.5% Dextrose AMBU-FLEX II CONTAINER 2.5 g 538 mg 448 mg 25.7 mg 5.08 mg 396 5.2
(4.0 to 6.5)
132 3.5 0.5 96 40 1000 1000 L5B5173 NDC 0941-0413-05
2000 3000 L5B5177 NDC 0941-0413-06
2500 3000 L5B5178 NDC 0941-0413-08
3000 3000 L5B5179 NDC 0941-0413-04
5000 6000 L5B5194 NDC 0941-0413-07
6000 6000 L5B9711 NDC 0941-0413-01
Dianeal® PD-2 Peritoneal Dialysis 2.5% Dextrose AMBU-FLEX III CONTAINER 2.5 g 538 mg 448 mg 25.7 mg 5.08 mg 396 5.2
(4.0 to 6.5)
132 3.5 0.5 96 40 250 500 5B5170 NDC 0941-0413-40
500 1000 5B5171 NDC 0941-0413-41
750 1000 5B5172 NDC 0941-0413-42
1000 1000 5B5173 NDC 0941-0413-43
1000 2000 5B5174 NDC 0941-0413-44
1500 2000 5B5175 NDC 0941-0413-45
2000 3000 5B5177 NDC 0941-0413-47
2500 3000 5B5178 NDC 0941-0413-48
3000 3000 5B5179 NDC 0941-0413-49
5000 5000 5B5194 NDC 0941-0413-25
6000 6000 5B9711 NDC 0941-0413-28
Dianeal® PD-2 Peritoneal Dialysis Solution with 3.5% Dextrose 3.5 g 538 mg 448 mg 25.7 mg 5.08 mg 447 5.2
(4.0 to 6.5)
132 3.5 0.5 96 40 2500 3000 5B4804 NDC 0941-0423-48
Dianeal® PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose AMBU-FLEX II CONTAINER 4.25 g 538 mg 448 mg 25.7 mg 5.08 mg 485 5.2
(4.0 to 6.5)
132 3.5 0.5 96 40 1000 1000 L5B5183 NDC 0941-0415-05
2000 3000 L5B5187 NDC 0941-0415-06
2500 3000 L5B5188 NDC 0941-0415-08
3000 3000 L5B5189 NDC 0941-0415-04
5000 6000 L5B5195 NDC 0941-0415-07
6000 6000 L5B9712 NDC 0941-0415-01
Dianeal® PD-2 Peritoneal Dialysis 4.25% Dextrose AMBU-FLEX III CONTAINER 4.25 g 538 mg 448 mg 25.7 mg 5.08 mg 485 5.2
(4.0 to 6.5)
132 3.5 0.5 96 40 250 500 5B5180 NDC 0941-0415-40
500 1000 5B5181 NDC 0941-0415-41
750 1000 5B5182 NDC 0941-0415-42
1000 1000 5B5183 NDC 0941-0415-43
1000 2000 5B5184 NDC 0941-0415-44
1500 2000 5B5185 NDC 0941-0415-45
2000 3000 5B5187 NDC 0941-0415-47
2500 3000 5B5188 NDC 0941-0415-48
3000 3000 5B5189 NDC 0941-0415-49
5000 5000 5B5195 NDC 0941-0415-25
6000 6000 5B9712 NDC 0941-0415-28

Potassium is omitted from DIANEAL solutions because dialysis may be performed to correct hyperkalemia. In situations in which there is a normal serum potassium level or hypokalemia, the addition of potassium chloride (up to a concentration of 4 mEq/L) may be indicated to prevent severe hypokalemia. Addition of potassium chloride should be made after careful evaluation of serum and total body potassium and only under the direction of a physician. Frequent monitoring of serum electrolytes is indicated.

Because average plasma magnesium levels in some chronic CAPD patients have been observed to be elevated (Nolph et al. 1981), the magnesium concentration of this formulation has been reduced to 0.5 mEq/L. Average plasma magnesium levels have not been reported for chronic IPD and CCPD patients. Serum magnesium levels should be monitored and if low, oral magnesium supplements, oral magnesium containing phosphate binders, or peritoneal dialysis solutions containing higher magnesium concentrations may be used.

Because average serum bicarbonate levels in some chronic CAPD patients (Nolph et al. 1981), some chronic IPD patients (La Greca et al. 1980), and some chronic CCPD patients (Diaz-Buxo et al. 1983) have been observed to be somewhat lower than normal values, the bicarbonate precursor (lactate) concentration of this formulation has been raised to 40 mEq/L. Serum bicarbonate levels should be monitored.

The osmolarities shown in Table 1 are calculated values. As an example, measured osmolarity by freezing point depression determination of DIANEAL PD-2 (peritoneal dialysis solution) peritoneal dialysis solution with 1.5% dextrose is approximately 334 mOsmol/L, compared with measured values in normal human serum of 280 mOsmol/L.

The plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

Last reviewed on RxList: 2/17/2009
This monograph has been modified to include the generic and brand name in many instances.

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