ialysis.
INFECTIONS AND INFESTATIONS: Fungal peritonitis, Peritonitis bacterial, Catheter related infectionMETABOLISM AND NUTRITION DISORDERS: Hypovolemia, Hypervolemia, Fluid retention, Hypokalemia,Hyponatremia, Dehydration, Hypochloremia
VASCULAR DISORDERS: Hypotension, Hypertension
RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS: Dyspnea
GASTROINTESTINAL DISORDERS: Sclerosing encapsulating peritonitis, Peritonitis, Peritoneal cloudy effluent,Vomiting, Diarrhea, Nausea, Constipation, Abdominal pain, Abdominal distension, Abdominal discomfort SKIN AND SUBCUTANEOUS DISORDERS: Stevens-Johnson syndrome, Urticaria, Rash, (including pruritic,erythematous and generalized), Pruritus
MUSCULOSKELETAL, CONNECTIVE TISSUE DISORDERS: Myalgia, Muscle spasms, Musculoskeletal painGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Generalized edema, Pyrexia, Malaise,Infusion site pain, Catheter related complication
7 DRUG INTERACTIONS
As with other dialysis solutions, blood concentrations of dialyzable drugs may be reduced by dialysis. Dosageadjustment of concomitant medications may be necessary.
Diabetic patients may require dosage adjustments of insulin or other treatments for hyperglycemia [see Warningsand Precautions (5.5)].
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
DIANEAL peritoneal dialysis solution is a pharmacologically inactive solution. While there are no adequate andwell controlled studies in pregnant women, appropriate administration of DIANEAL solutions, with appropriatemonitoring of hematology, electrolytes, blood chemistry and fluid status is not expected to cause fetal harm. Animalreproduction studies have not been conducted with DIANEAL solutions.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Inthe U.S. general population, the estimated background risk of major birth defects and miscarriage in clinicallyrecognized pregnancies is 2-4% and 15-20%, respectively.
8.2 Lactation
The components of DIANEAL solutions are excreted in human milk.
8.4 Pediatric Use
Safety and effectiveness have been established based on published clinical data. No adequate and well-controlledstudies have been conducted with DIANEAL solutions in pediatric patients.
8.5 Geriatric Use
Safety and effectiveness have been established based on published clinical data.
10 OVERDOSAGE
There is a potential for overdose resulting in hypervolemia, hypovolemia, electrolyte disturbances or hyperglycemia.
Excessive use of DIANEAL peritoneal dialysis solution with 4.25% dextrose during a peritoneal dialysis treatmentcan result in significant removal of water from the patient.
11 DESCRIPTION
DIANEAL peritoneal dialysis solutions are sterile, nonpyrogenic solutions in flexible containers for intraperitonealadministration only. The peritoneal dialysis solutions contain no bacteriostatic or antimicrobial agents.
DIANEAL solutions are hyperosmolar solutions.
Table 4 - DIANEAL PD-2 and Low Calcium Peritoneal Dialysis SolutionULTRABAG Container for CAPD therapyAMBU-FLEX 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
&bul |
