FDA label 000b8a5a-7408-458f-a623-17bd6be9a6e6
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
- aea9c02c-eddf-435f-969c-e8ac9aaddadd
- SPL ID
- 000b8a5a-7408-458f-a623-17bd6be9a6e6
- Version
- 5
- Effective date
- 2002-02-02
- Source export date
- 2026-10-12
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:29:37
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 | 000b8a5a-7408-458f-a623-17bd6be9a6e6 | id | |
| spl set id | aea9c02c-eddf-435f-969c-e8ac9aaddadd | 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. Contamination of Luer lock connector may result in peritonitis. An improper clamping sequence may result in infusion of air into the peritoneum. Peritoneal dialysis should be done with great care, if at all, 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. 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 Dianeal ® PD-2 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. If the resealable rubber plug on the medication port is missing or partially removed, do not use product. After removing overpouch, check for minute leaks by squeezing container firmly. If leaks are found, discard the solution because the sterility may be impaired. After the pull ring has been removed from the outlet, check for broken connector frangible seal as evidenced by continuous fluid flow from port. A few drops of solution within the connector or protector cap may be present. If a continuous stream or droplets of fluid are noted, discard solution because sterility may be impaired. During solution drainage, fibrin strands may be observed in the solution and may become attached to the connector frangible closure. In occasional instances, partial or complete obstruction of draining may occur. Manipulation of the connector frangible closure in the tubing may free the fibrin obstruction.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Adverse reactions to 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 the peritoneal catheter, catheter site infection, catheter blockage, difficulty in fluid removal, and ileus are among the complications of the procedure. Solution related adverse reactions may include peritonitis, electrolyte and fluid imbalances, hypovolemia, hypervolemia, hypotension, hypertension, disequilibrium syndrome, allergic symptoms, and muscle cramping.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.