DIANEAL Low Calcium with Dextrose

DIANEAL Low Calcium with Dextrose is an FDA-registered drug product whose active ingredient is SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE. It is labelled by Vantive US Healthcare LLC taken by intraperitoneal and marketed as a human prescription drug product. Identifiers on file: NDC 0941-0409, application NDA017512, label effective 20260416. 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 SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE are most often described in connection with: acute chronic, renal failure, usage dianeal, peritoneal dialysis. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE DIANEAL peritoneal dialysis solutions are indicated for patients in acute or chronic renal failure. For management of acute or chronic renal failure.

2 DOSAGE AND ADMINISTRATION For intraperitoneal administration only. ( 2 ) 2.1 Basic Dosing Information DIANEAL peritoneal dialysis solutions are intended for intraperitoneal administration only. Not for intravenous or intra-arterial administration. Select mode of therapy, frequency of treatment, formulation, fill volume, duration of dwell, and length of dialysis based on the patient’s clinical condition, fluid, electrolyte and specific needs. The fill volume depends on body size, usually from 2.0 to 2.5 liters per 1.73m 2 for adults. DIANEAL peritoneal dialysis solutions are intended for use in Continuous Ambulatory Peritoneal Dialysis (CAPD) or Automated Peritoneal Dialysis (APD). Refer to directions accompanying ancillary equipment for CAPD and APD system preparation. Product Selection To avoid the risk of severe dehydration and hypovolemia and to minimize the loss of protein, it is advisable to select the peritoneal dialysis solution with the lowest level of osmolarity consistent with the fluid removal requirements for that exchange. As the patient’s body weight becomes closer to the ideal dry weight, lowering the dextrose concentration of DIANEAL solution is recommended. DIANEAL 4.25% dextrose-containing solution has the highest osmolarity of the DIANEAL solutions and using it for all exchanges may cause dehydration [see Dosage Forms and Strengths (3) ] . 2.2 Adding Medications If the resealable rubber plug on the medication port is missing or partly removed, do not use the product if medication is to be added. To add a medication: 1. Put on mask. Clean and/or disinfect hands. 2. Prepare medication port site using aseptic technique. 3. Using a syringe with a 1-inch long, 25- to 19-gauge needle, puncture the medication port and inject additive. 4. Reposition container with container ports up and evacuate medication port by squeezing and tapping it. 5. Mix solution and additive thoroughly. 2.3 Directions for Use Warming DIANEAL peritoneal dialysis solution can be warmed to 37°C (98.6°F). Only dry heat should be used. For CAPD, it is best to warm solutions within the overwrap using a heating pad. Do not immerse DIANEAL solutions in water for warming. Do not use a microwave oven to warm DIANEAL solutions. To Open To open, tear the overwrap down at the slit and remove the solution container. Do not use sharp objects to remove the overwrap. Product Inspection Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use solutions that are cloudy, discolored, contain visible particulate matter, or show evidence of leakage. Some opacity of the plastic, due to moisture absorption during the sterilization process, may be observed. This does not affect the solution quality or safety and may often leave a slight amount of moisture within the overwrap. The opacity should diminish gradually. Inspect the bag connector to ensure the tip protector (pull ring or blue pull tip) is attached. Do not use if the tip protector is not attached to the connector. Inspect the DIANEAL solution container for signs of leakage and check for minute leaks by squeezing the container firmly. If the container has frangible(s), inspect that they are positioned correctly and are not broken. Do not use DIANEAL solution if the frangible(s) are broken or leaks are suspected as sterility may be impaired. For DIANEAL solutions in ULTRABAG containers, inspect the tubing and drain container for presence of solution. Small droplets are acceptable, but if solution flows past the frangible prior to use, do not use and discard the units. CAPD therapy using ULTRABAG containers Select appropriate formulation from Table 1. Put on mask. Clean and/or disinfect hands. Using aseptic technique; 1. Uncoil tubing and drain bag, ensuring that the transfer set is closed. 2. Break the connector (Y-set) frangible. 3. Remove the tip protector from connector of solution container. Do not reuse the solution or container once the tip protector is removed. 4. Immediately attach the solution container to patient connector (transfer set). 5. Clamp solution line and then break frangible near solution bag. Hang solution container and place the drainage container below the level of the abdomen. 6. Open transfer set to drain the solution from abdomen. If drainage cannot be established, contact your clinician. When drainage complete, close transfer set. 7. Remove clamp from solution line and flush new solution to flow into the drainage container for 5 seconds to prime the line. Clamp drain line after flush complete. 8. Open transfer set to fill. When fill complete, close transfer set. 9. Disconnect ULTRABAG container from transfer set and apply MINICAP disconnect cap. 10. Upon completion of therapy, discard any unused portion. APD therapy using AMBU-FLEX containers with pull rings or plastic containers with blue pull tips or pull rings Select appropriate formulation from Table 1, 2 or 3. Put on mask. Clean and/or disinfect hands. Using aseptic technique; 1. Remove the tip protector from connector of solution container. Do not reuse the solution or container once the tip protector is removed. 2. Immediately attach the solution container to an appropriate automated peritoneal dialysis set. 3. Continue therapy as instructed in user manual or directions accompanying tubing sets for automated peritoneal dialysis. 4. Upon completion of therapy, discard any unused portion.

4 CONTRAINDICATIONS DIANEAL peritoneal dialysis solutions are contraindicated in patients with severe lactic acidosis. • Pre-existing severe lactic acidosis ( 4 )

6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the label: Peritonitis and Encapsulating Peritoneal Sclerosis [see Warnings and Precautions (5.1) ] Electrolyte and Fluid Imbalances [see Warnings and Precautions (5.4) ] To report SUSPECTED ADVERSE REACTIONS, contact Vantive US Healthcare LLC at 1-855-857-0003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience There are no data available on adverse reactions from controlled clinical trials conducted to evaluate the safety of DIANEAL peritoneal dialysis solutions. 6.2 Post-Marketing Experience The following adverse experiences have been identified during post-approval use of DIANEAL solutions or in conjunction with performing the peritoneal dialysis procedure. Because these experiences are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship during drug exposure. Most of these adverse experiences are believed to be consequences of peritoneal dialysis. INFECTIONS AND INFESTATIONS: Fungal peritonitis, Peritonitis bacterial, Catheter related infection METABOLISM AND NUTRITION DISORDERS: Hypovolemia, Hypervolemia, Fluid retention, Hypokalemia, Hyponatremia, Dehydration, Hypochloremia VASCULAR DISORDERS: Hypotension, Hypertension RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS: Dyspnea GASTROINTESTINAL DISORDERS: Sclerosing encapsulating peritonitis, Peritonitis, Peritoneal cloudy effluent, Vomiting, Diarrhea, Nausea, Constipation, Abdominal pain, Abdominal distension, Abdominal discomfort SKIN AND SUBCUTANEOUS DISORDERS: Stevens-Johnson syndrome, Urticaria, Rash, (including pruritic, erythematous and generalized), Pruritus MUSCULOSKELETAL, CONNECTIVE TISSUE DISORDERS: Myalgia, Muscle spasms, Musculoskeletal pain GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Generalized edema, Pyrexia, Malaise, Infusion site pain, Catheter related complication

What is DIANEAL Low Calcium with Dextrose used for?
1 INDICATIONS AND USAGE DIANEAL peritoneal dialysis solutions are indicated for patients in acute or chronic renal failure. For management of acute or chronic renal failure.

Who makes DIANEAL Low Calcium with Dextrose?
Vantive US Healthcare LLC is the labeler of record for DIANEAL Low Calcium with Dextrose.

What form does DIANEAL Low Calcium with Dextrose 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 DIANEAL Low Calcium with Dextrose 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.

Has DIANEAL Low Calcium with Dextrose been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.