FDA label 8dbee83f-7418-705e-e053-2a95a90af5f1
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- SPL set ID
- 637727c1-29bc-11e2-81c1-0800200c9a66
- SPL ID
- 8dbee83f-7418-705e-e053-2a95a90af5f1
- Version
- 5
- Effective date
- 2019-07-15
- Source export date
- 2026-09-28
- Source partition
- 6
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:41:32
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 8dbee83f-7418-705e-e053-2a95a90af5f1 | id | |
| spl set id | 637727c1-29bc-11e2-81c1-0800200c9a66 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings Not for Intravenous Injection. Use Aseptic Technique. It is important to mix the buffer (Mini-Bag) and main solutions thoroughly. Administer within 24 hours after mixing. Once solutions are mixed, other prescribed medication(s) may be added prior to administration. After removing the outerwrap, check for minute leaks by squeezing each of the solution bags firmly. If leaks are found, discard the solution because the sterility may be impaired. (A small amount of moisture may be present inside the outerwrap, which is normal condensation from the sterilization process). Peritoneal dialysis should be done with great care, in patients with a number of conditions, including disruption of the peritoneal membrane or diaphragm by surgery or trauma, extensive adhesions, bowel distention, undiagnosed abdominal disease, abdominal wall infection, hernias or burns, fecal fistula or colostomy, tense ascites, obesity, large polycystic kidneys, recent aortic graft replacement, lactic acidosis and severe pulmonary disease. When assessing peritoneal dialysis as the mode of therapy in such extreme situations, the benefits to the patient must be weighed against the possible complications. Solutions containing lactate ion should be used with great care in patients with metabolic or respiratory alkalosis. Lactate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency. An accurate fluid balance record must be kept and the weight of the patient carefully monitored to avoid over or under hydration with severe consequences, including congestive heart failure, volume depletion and shock. Excessive use of DELFLEX ® peritoneal dialysis solution with 4.25% dextrose during a peritoneal dialysis treatment can result in significant removal of water from the patient. Stable patients undergoing maintenance peritoneal dialysis should have routine periodic evaluation of blood chemistries and hematologic factors, as well as other indicators of patient status. Serum calcium levels in patients using low calcium concentrations should be monitored and if found to be low, the peritoneal solution in use should be altered to one with a higher calcium concentration.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
Adverse Reactions Adverse reactions occurring with administration of peritoneal dialysis include mechanical and solution related problems as well as the results of contamination of equipment or improper technique in catheter placement. Abdominal pain, bleeding, peritonitis, subcutaneous infection around a peritoneal catheter, catheter blockage, difficulty in fluid removal, and ileus are among the complications of the procedure. Solution related adverse reactions might include peritonitis, catheter site infection, electrolyte and fluid imbalances, hypovolemia, hypervolemia, hypertension, hypotension, disequilibrium syndrome and muscle cramping. If an adverse reaction does occur, institute appropriate therapeutic procedures according to the patient’s needs and conditions, and save the remainder of the fluid in the bag for evaluation if deemed necessary.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.