Dianeal PD-2

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.

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.