DELFLEX

DELFLEX is an FDA-registered drug product whose active ingredient is DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE. It is labelled by Fresenius Medical Care Renal Therapies Group, LLC taken by intraperitoneal and marketed as a human prescription drug product. Identifiers on file: NDC 49230-188, application NDA018883, label effective 20260818. It is one of 4 FDA drug label records sharing the active ingredient DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE are most often described in connection with: treatment chronic, kidney failure, usage delflex, maintained peritoneal. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 )

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 any moisture from the solution bags. Some opacity may be observed in the plastic of the bag and/or tubing and is due to moisture absorption during the sterilization process. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Wipe away any moisture from the solution bags. Inspect DELFLEX Solution Bag After removing the overwrap, check your DELFLEX solution bag(s) for strength, clarity, amount, leaks, and expiration date. Do not use DELFLEX solution if leaks are found, the solution bag is damaged, and/or the solution is cloudy or discolored, or the product is expired. Color may vary from clear to slightly yellow but does not affect efficacy and may be used. Visually check that the solution bag tubing is free from kinks. If kinks are present, straighten tubing to allow the solution to flow freely. Note: Retain DELFLEX peritoneal dialysis bag sample for manufacturer evaluation and notify your healthcare provider if any of the above defects are found. Note: DELFLEX peritoneal dialysis solutions utilize the Safe-Lock® Connection System. This unique system consists of two Safe-Lock connectors, one located on the administration port of the bag, and the mating connector is located on the cycler set. The Safe-Lock connectors were designed to reduce the potential risk of touch contamination of the internal connection components. Put on mask. Wash your hands. If you will be adding medications(s): Clean hands (as per facility's protocol) Clean the medication port as instructed by your healthcare provider. Add the medicine(s). Turn the bag upside down several times to mix the medicine(s). To connect the bag(s) to the cycler set, unscrew the protective caps of the administration port and the cycler set solution line connector. Secure these two connectors with a twisting motion to lock in place, so that the cycler set connector is seated over the administration port O-ring to assure a firm and tight fit. After completing Step 8, wait for the cycler prompt to break the administration port cone and initiate solution flow. Do this by placing the thumb firmly on the tube over the cone and pressing towards the outer wall of the tube and away from the bag. Perform your treatment as prescribed. At the end of your treatment, throw away the fluid and used set as instructed by your healthcare provider. In case of cloudiness, save the fluid and the used set and immediately contact your healthcare provider. Dispose of your empty solution bag according to your local recycling program. Empty solution bags may not be recyclable in your area. Figure Figure Figure Figure 2.3 Compatible Medications Compatible medications can be added via the medication port [see Dosage and Administration ( 2.2 )]. The following medications have demonstrated stability with DELFLEX solutions: cefazolin, ceftazidime, gentamicin, and vancomycin [see Clinical Pharmacology ( 12.3 )] .

4. CONTRAINDICATIONS None. None

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.

FDA lists 4 drug label records with DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is DELFLEX used for?
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 )

Who makes DELFLEX?
Fresenius Medical Care Renal Therapies Group, LLC is the labeler of record for DELFLEX. 4 FDA label records share the active ingredient DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does DELFLEX come in?
administered by intraperitoneal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is DELFLEX prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE?
Yes. 4 FDA drug label records list DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has DELFLEX been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.