l;6H2O)
DIANEAL PD-2
1.5% Dextrose
1.5 g 538 mg 448 mg 25.7 mg 5.08 mg
DIANEAL PD-2
2.5% Dextrose
2.5 g 538 mg 448 mg 25.7 mg 5.08 mg
DIANEAL PD-2
4.25% Dextrose
4.25 g 538 mg 448 mg 25.7 mg 5.08 mg
DIANEAL Low Calcium
(2.5 mEq/L)
1.5% Dextrose
1.5 g 538 mg 448 mg 18.3 mg 5.08 mg
DIANEAL Low Calcium
(2.5 mEq/L)
2.5% Dextrose
2.5 g 538 mg 448 mg 18.3 mg 5.08 mg
DIANEAL Low Calcium
(2.5 mEq/L)
4.25% Dextrose
4.25 g 538 mg 448 mg 18.3 mg 5.08 mg
Table 5 - DIANEAL Low Calcium Peritoneal Dialysis Solution
Plastic container with blue pull tip for APD therapy
Composition/100 mL
*Dextrose,
Hydrous
Sodium
Chloride
(NaCl)
Sodium
Lactate
(C3H5NaO3
)
Calcium
Chloride
(CaCl2
•2H2O)
Magnesium
Chloride
(MgCl2
•6H2O)
DIANEAL Low Calcium
(2.5 mEq/L)
1.5% Dextrose
1.5 g 538 mg 448 mg 18.4 mg 5.08 mg
DIANEAL Low Calcium
(2.5 mEq/L)
2.5% Dextrose
2.5 g 538 mg 448 mg 18.4 mg 5.08 mg
DIANEAL Low Calcium
(2.5 mEq/L)
4.25% Dextrose
4.25 g 538 mg 448 mg 18.4 mg 5.08 mg
Table 6 - DIANEAL Low Calcium Peritoneal Dialysis Solution
Plastic container with pull ring for APD therapy
Composition/100 mL
*Dextrose,
Hydrous,
USP
Sodium
Chloride,
USP (NaCl)
Sodium
Lactate
(C3H5NaO3
)
Calcium
Chloride, USP
(CaCl2
•2H2O)
Magnesium
Chloride, USP
(MgCl2
•6H2O)
DIANEAL Low Calcium
(2.5 mEq/L)
1.5% Dextrose
1.5 g 538 mg 448 mg 18.3 mg 5.08 mg
DIANEAL Low Calcium
(2.5 mEq/L)
2.5% Dextrose
2.5 g 538 mg 448 mg 18.3 mg 5.08 mg
The plastic container is fabricated from polyvinyl chloride (PVC Plastic). Exposure to temperatures above25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead togreater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expirationperiod. The amount of water that can permeate from inside the solution container into the overwrap is insufficient toaffect the solution significantly.
Solutions in contact with the plastic container can leach out certain of its chemical components in very smallamounts within the expiration period, e.g. di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, thesafety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers aswell as by cell culture toxicity studies.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
DIANEAL peritoneal dialysis solutions are a pharmacologically inactive, hypertonic peritoneal dialysis solutioncontaining dextrose, a monosaccharide, as the primary osmotic agent. An osmotic gradient must be created betweenthe peritoneal membrane and the dialysis solution in order for ultrafiltration to occur. The hypertonic concentrationof glucose in DIANEAL solutions exert an osmotic pressure across the peritoneal membrane resulting intranscapillary ultrafiltration. Like other peritoneal dialysis solutions, DIANEAL solutions contain electrolytes tofacilitate the correction of electrolyte abnormalities. DIANEAL solutions contain a buffer, lactate, to help normalizeacid-base abnormalities.
12.3 Pharmacokinetics
Absorption
Glucose is rapidly absorbed from the peritoneal cavity by diffusion and appears quickly in the circulation due to thehigh glucose conc |
