DELFLEX 25.7 mg/100mL
Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride · SOLUTION · Fresenius Medical Care North America
DELFLEX is a solution containing dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride at 25.7 mg/100mL, taken intraperitoneal. Manufactured by Fresenius Medical Care North America.
Key Facts
- Brand Name
- DELFLEX
- Generic Name
- Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride
- NDC Code (Product)
49230-191- Manufacturer
- Fresenius Medical Care North America
- Strength
- 25.7 mg/100mL
- Dosage Form
- SOLUTION
- Route
- INTRAPERITONEAL
- Marketing Status
- Application #
- NDA018883
- Marketing Start
- 11/30/1984
Recall History
Fresenius Medical Care, North America
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Fresenius Medical Care Holdings, Inc.
Temperature Abuse: Product exposed to temperature outside specified limits.
Fresenius Medical Care Holdings, Inc.
Temperature Abuse: Product exposed to temperature outside specified limits.
Fresenius Medical Care Holdings, Inc.
Lack of Sterility Assurance
Fresenius Medical Care Holdings, Inc.
Temperature Abuse: Product exposed to temperature outside specified limits.
Fresenius Medical Care Holdings, Inc.
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Fresenius Medical Care Holdings, Inc.
Temperature Abuse: Product exposed to temperature outside specified limits.
Fresenius Medical Care Holdings, Inc.
Temperature Abuse: Product exposed to temperature outside specified limits.
Fresenius Medical Care Renal Therapies Group, LLC
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Fresenius Medical Care Holdings, Inc.
Temperature Abuse: Product exposed to temperature outside specified limits.
Full Prescribing Information
Indications & Usage
1. INDICATIONS AND USAGE DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis. For treatment of chronic kidney failure. ( 1 )
Dosage & Administration
2. DOSAGE AND ADMINISTRATION For intraperitoneal dialysis only. ( 2 ) 2.1 Basic Dosing Information DELFLEX® is intended for intraperitoneal administration only. Not for intravenous or intra-arterial administration. The mode of therapy, frequency of treatment, formulation, exchange volume, duration of dwell, and length of dialysis should be selected by the physician responsible for the treatment of the individual patient. Utilize the peritoneal dialysis solution with lowest level of osmolarity consistent with the fluid removal requirements for that exchange. Do not store solutions containing additives. 2.2 Administration Instructions Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not heat in a microwave oven. Get Ready Clean work surface. Gather supplies: DELFLEX peritoneal dialysis bag(s). Prescribed medication(s), if ordered by your healthcare provider. Mask. PVC Tear the overwrap from the slit edge down the length of the inner bag to open. Locate pull tabs on overwrap. Grasping one tab in each hand, pull outward, down the length of the inner bag to open. Wipe away an…
Contraindications
4. CONTRAINDICATIONS None. None
Adverse Reactions
6. ADVERSE REACTIONS Solution related adverse reactions may include peritonitis, catheter site infection, electrolyte and fluid imbalances, hypovolemia, hypervolemia, hypertension, hypotension, disequilibrium syndrome, muscle cramping, abdominal pain, abdominal distension, and abdominal discomfort. Adverse reactions may include peritonitis, catheter site infection, electrolyte and fluid imbalances, hypovolemia, hypervolemia, hypertension, disequilibrium syndrome, muscle cramping, abdominal pain, abdominal distension, and abdominal discomfort. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Medical Care North America at 1-800-323-5188 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is DELFLEX used for?
DELFLEX contains Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride. It is a solution taken intraperitoneal. Consult your doctor for specific uses.
Is DELFLEX a controlled substance?
DELFLEX is not classified as a controlled substance by the DEA.
What is the generic name for DELFLEX?
The generic name for DELFLEX is Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride. There are 3 other brand versions of Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride.
What is the NDC code for DELFLEX 25.7 mg/100mL?
The NDC (National Drug Code) for DELFLEX 25.7 mg/100mL is 49230-191, listed by Fresenius Medical Care North America.