Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride

FDA Drug Information • Also known as: Delflex

Brand Names: Delflex
Route: INTRAPERITONEAL
Dosage Form: SOLUTION
Product Type: HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION The DELFLEX® peritoneal dialysis solutions (low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. The stay

safe exchange set utilizes an easy to use dial designed to eliminate the use of clamps and to prevent touch contamination of internal connection components. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2 . Table 2. Composition, calculated osmolarity, pH and ionic concentration Composition/100mL Total Osmolarity (mOsmoL/L) (calc) pH (5.0 - 6.0) Ionic Concentration (mEq/L) Dextrose Hydrous, USP (C 6 H 12 O 6

H 2 O) Sodium Chloride, USP (NaCl) Sodium Lactate (C 3 H 5 NaO 3 ) Calcium Chloride, USP (CaCl 2

2H 2 O) Magnesium Chloride, USP (MgCl 2

6H 2 O) Sodium Calcium Magnesium Chloride Lactate DELFLEX Low Magnesium, Low Calcium with 1.5% Dextrose 1.5 g 538 mg 448 mg 18.4 mg 5.08 mg 344 5.5 132 2.5 0.5 95 40 DELFLEX Low Magnesium, Low Calcium with 2.5% Dextrose 2.5 g 538 mg 448 mg 18.4 mg 5.08 mg 394 5.5 132 2.5 0.5 95 40 DELFLEX Low Magnesium, Low Calcium with 4.25% Dextrose 4.25g 538 mg 448 mg 18.4 mg 5.08 mg 483 5.5 132 2.5 0.5 95 40 Dextrose, USP, is chemically designated D-glucose monohydrate (C 6 H 12 O 6

H 2 O) a hexose sugar freely soluble in water. The structural formula is shown here: Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 2

2H 2 O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 2

6H 2 O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3 CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP,...

What Is Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride 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 )

Dosage and Administration

2 DOSAGE AND ADMINISTRATION ( 1 ) 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 and gather supplies: Masks (enough for everyone in the room). Warmed DELFLEX peritoneal dialysis solution bag with attached stay

safe exchange set. stay

safe organizer, a stand-alone item provided separately. Povidone iodine prefilled stay

safe cap, a stand-alone item provided separately. IV Pole (optional). Prescribed medication(s), if ordered by your healthcare provider. 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, the solution is cloudy or discolored, and/or the product is expired. Color may vary from clear to slightly yellow but does not affect efficacy and may be used. Prepare supplies: Retrieve stay

safe catheter extension set and ensure clamp is closed. Tear the overwrap from the slit edge 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. 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. Put on mask. Wash your hands per facility protocol. Position the stay

safe organizer at the edge of your clean work surface or with the stay

safe holder on the IV pole. Remove color-coded cover: Turn the blue dial as directed by the arrow in the color—coded cover. Remove the colored—coded cover from the stay

safe DISC. The blue dial will be in Position 1 ( ) DRAIN. Prepare organizer and solution bag: Place the stay

safe DISC and tubing into the organizer and tubing channels on the organizer. If you will be adding medication(s): Clean hands (as per facility's protocol). Clean the medication port as instructed by your healthcare...

Side Effects (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.

Contraindications

4 CONTRAINDICATIONS None. None

Pregnancy and Breastfeeding

8.1 Pregnancy Risk Summary DELFLEX solutions consist of electrolytes, lactate, and bicarbonate at physiological levels, and glucose to facilitate ultrafiltration. While there are no adequate and well controlled studies in pregnant women, appropriate administration of DELFLEX with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to cause fetal harm. Animal reproduction studies have not been conducted with DELFLEX. The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING DELFLEX peritoneal dialysis solutions with attached stay

safe exchange set are available in the sizes and formulations shown in Table 1 [ Dosage Forms and Strengths ].( 3 ) Table 3. DELFLEX peritoneal dialysis with attached stay

safe exchange set NDC designations Magnesium (Mg); Calcium (Ca) 2L 2.5L 3L Low Mg/Low Ca 1.5% Dextrose 49230-206-92 49230-206-94 49230-206-95 Low Mg/Low Ca 2.5% Dextrose 49230-209-92 49230-209-94 49230-209-95 Low Mg/Low Ca 4.25% Dextrose 49230-212-92 49230-212-94 49230-212-95 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F). See USP Controlled Room Temperature. Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Keep DELFLEX and all medicines out of the reach of children.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.