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Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose

FDA Drug Information • Also known as: Dianeal Low Calcium With Dextrose, Dianeal Pd-2 With Dextrose

Brand Names
Dianeal Low Calcium With Dextrose, Dianeal Pd-2 With Dextrose
Route
INTRAPERITONEAL
Dosage Form
INJECTION, SOLUTION
Product Type
HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION DIANEAL peritoneal dialysis solutions are sterile, nonpyrogenic solutions in flexible containers for intraperitoneal administration only. The peritoneal dialysis solutions contain no bacteriostatic or antimicrobial agents. DIANEAL solutions are hyperosmolar solutions. Table 4 - DIANEAL PD-2 and Low Calcium Peritoneal Dialysis Solution ULTRABAG Container for CAPD therapy AMBU-FLEX/Plastic Container with pull ring for APD therapy Composition/100 mL *Dextrose, Hydrous, USP Sodium Chloride, USP (NaCl) Sodium Lactate (C3H5NaO3) Calcium Chloride, USP (CaCl2

  • 2H2O) Magnesium Chloride, USP (MgCl2
  • 6H2O) DIANEAL PD-2 1.5% Dextrose 1.5 g 538 mg 448 mg 25.7 mg 5.08 mg DIANEAL PD-2 2.5% Dextrose 2.5 g 538 mg 448 mg 25.7 mg 5.08 mg DIANEAL PD-2 4.25% Dextrose 4.25 g 538 mg 448 mg 25.7 mg 5.08 mg DIANEAL Low Calcium (2.5 mEq/L) 1.5% Dextrose 1.5 g 538 mg 448 mg 18.3 mg 5.08 mg DIANEAL Low Calcium (2.5 mEq/L) 2.5% Dextrose 2.5 g 538 mg 448 mg 18.3 mg 5.08 mg DIANEAL Low Calcium (2.5 mEq/L) 4.25% Dextrose 4.25 g 538 mg 448 mg 18.3 mg 5.08 mg Table 5 - DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic container with blue pull tip for APD therapy Composition/100 mL *Dextrose, Hydrous Sodium Chloride (NaCl) Sodium Lactate (C3H5NaO3) Calcium Chloride (CaCl2
  • 2H2O) Magnesium Chloride (MgCl2
  • 6H2O) DIANEAL Low Calcium (2.5 mEq/L) 1.5% Dextrose 1.5 g 538 mg 448 mg 18.4 mg 5.08 mg DIANEAL Low Calcium (2.5 mEq/L) 2.5% Dextrose 2.5 g 538 mg 448 mg 18.4 mg 5.08 mg DIANEAL Low Calcium (2.5 mEq/L) 4.25% Dextrose 4.25 g 538 mg 448 mg 18.4 mg 5.08 mg The plastic container is fabricated from polyvinyl chloride (PVC Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the solution container into the...

    • What Is Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And 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.

    Dosage and Administration

    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....

    Side Effects (Adverse Reactions)

    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

    Drug Interactions

    7 DRUG INTERACTIONS As with other dialysis solutions, blood concentrations of dialyzable drugs may be reduced by dialysis. Dosage adjustment of concomitant medications may be necessary. Diabetic patients may require dosage adjustments of insulin or other treatments for hyperglycemia [see Warnings and Precautions (5.5) ].

    Contraindications

    4 CONTRAINDICATIONS DIANEAL peritoneal dialysis solutions are contraindicated in patients with severe lactic acidosis.

  • Pre-existing severe lactic acidosis ( 4 )

    • Pregnancy and Breastfeeding

    8.1 Pregnancy DIANEAL peritoneal dialysis solution is a pharmacologically inactive solution. While there are no adequate and well controlled studies in pregnant women, appropriate administration of DIANEAL solutions, with appropriate monitoring of hematology, electrolytes, blood chemistry and fluid status is not expected to cause fetal harm. Animal reproduction studies have not been conducted with DIANEAL solutions. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

    Overdosage

    10 OVERDOSAGE There is a potential for overdose resulting in hypervolemia, hypovolemia, electrolyte disturbances or hyperglycemia. Excessive use of DIANEAL peritoneal dialysis solution with 4.25% dextrose during a peritoneal dialysis treatment can result in significant removal of water from the patient.

    How Supplied

    16 HOW SUPPLIED/STORAGE AND HANDLING DIANEAL peritoneal dialysis solutions are available in the following single-dose containers and fill volumes as shown in Tables 6-7: Table 6 - DIANEAL Peritoneal Dialysis Solutions for CAPD therapy Container Fill Volume (mL) Container Size (mL) Product Code NDC ULTRABAG Container DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose 2000 2500 2000 3000 5B9866 5B9868 0941-0426-52 0941-0426-53 DIANEAL PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose 2000 2500 2000 3000 5B9876 5B9878 0941-0427-52 0941-0427-53 DIANEAL PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose 2000 2500 2000 3000 5B9896 5B9898 0941-0429-52 0941-0429-53 DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose 1500 2000 2500 2000 2000 3000 5B9765 5B9766 5B9768 0941-0424-51 0941-0424-52 0941-0424-53 DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 1500 2000 2500 2000 2000 3000 5B9775 5B9776 5B9778 0941-0430-51 0941-0430-52 0941-0430-53 DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose 1500 2000 2500 2000 2000 3000 5B9795 5B9796 5B9798 0941-0433-51 0941-0433-52 0941-0433-53 Table 7 - DIANEAL Peritoneal Dialysis Solutions for APD therapy Container Fill Volume (mL) Container Size (mL) Product Code NDC AMBU-FLEX / Plastic Container with pull ring DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose 1000 2000 3000 5000 6000 1000 3000 3000 6000 6000 L5B5163 L5B5166 L5B5169 L5B5193 L5B9710 0941-0411-05 0941-0411-06 0941-0411-04 0941-0411-07 0941-0411-11 DIANEAL PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose 1000 2000 3000 5000 6000 1000 3000 3000 6000 6000 L5B5173 L5B5177 L5B5179 L5B5194 L5B9711 0941-0413-05 0941-0413-06 0941-0413-04 0941-0413-07 0941-0413-01 DIANEAL PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose 1000 2000 3000 5000 6000 1000 3000 3000 6000 6000 L5B5183 L5B5187 L5B5189 L5B5195 L5B9712 0941-0415-05 0941-0415-06 0941-0415-04...

    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.