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Dianeal PD1

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Dianeal PD-1

DIANEAL PD-1
(peritoneal) Dialysis Solution
AMBU-FLEX III Container
For Peritoneal Dialysis For intraperitoneal administration only

DRUG DESCRIPTION

DIANEAL PD-1 peritoneal dialysis solutions in AMBU-FLEX lll containers with a flanged port are sterile, nonpyrogenic solutions for intraperitoneal administration only. They contain no bacteriostatic or antimicrobial agents or added buffers.

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

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.

The osmolarities shown in Table 1 are calculated values. As an example, measured osmolarity by freezing point depression determination of DIANEAL PD-1 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.

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
(C3H5NaO3)
Calcium Chloride, USP
(CaCl2·2H2O)
Magnesium Chloride, USP
MgCl2·6H2O)
Sodium Calcium Magnesium Chloride Lactate Fill
Volume
(mL)
Container
Size
(mL)
Code NDC
DIANEAL PD-1
Peritoneal
Dialysis
Solution with
1.5% Dextrose
1.5
g
567
mg
392
mg
25.7
mg
15.2
mg
347 5.2
(4.0 to 6.5)
132 3.5 1.5 102 35 2000
5000
2000
5000
5B5136
5B5190
NDC 0941-0377-46
NDC 0941-0377-25
DIANEAL PD-1
Peritoneal
Dialysis
Solution with
2.5% Dextrose
2.5
g
567
mg
392
mg
25.7
mg
15.2
mg
398 5.2
(4.0 to 6.5)
132 3.5 1.5 102 35 2000
2000
5000
2000
3000
5000
5B5146
5B5147
5B5191
NDC 0941-0383-46
NDC 0941-0383-47
NDC 0941-0383-25
DIANEAL PD-1
Peritoneal
Dialysis
Solution with
4.25% Dextrose
4.25 567
mg
392
mg
25.7
mg
15.2
mg
486 5.2
(4.0 to 6.5)
132 3.5 1.5 102 35 2000
5000
3000
5000
5B5157
5B5192
NDC 0941-0379-47
NDC 0941-0379-25

Last reviewed on RxList: 12/25/2005
This monograph has been modified to include the generic and brand name in many instances.

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