Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride
Generic Name: dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
Brand Names:
Delflex
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.
Overview
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.
Uses
1. INDICATIONS AND USAGE DELFLEX® is indicated in the treatment of chronic kidney failure patients being maintained on peritoneal dialysis For treatment of chronic kidney failure. ( 1 )
Dosage
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.
Side Effects
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 .
Warnings
5. Warnings and Precautions Monitor patient for electrolyte, fluid, and nutrition imbalances. ( 5.1 ) Encapsulating Peritoneal Sclerosis (EPS) ( 5.2 ) Peritonitis: Initiate appropriate antimicrobial therapy ( 5.2 ) Monitor for Lactic Acidosis in patients at risk. ( 5.3 ) 5.1 Electrolyte, Fluid and Nutrition Imbalances Peritoneal dialysis may affect a patient's protein, water-soluble vitamin, potassium, sodium, chloride, bicarbonate, and magnesium levels and volume status. Monitor electrolytes and blood chemistry periodically and take appropriate clinical action. Potassium is omitted from DELFLEX solutions because dialysis may be performed to correct hyperkalemia. 4. Contraindications None. None
Pregnancy
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.
Storage
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) DELFLEX peritoneal dialysis solutions are delivered in transparent, single-dose flexible bags. The solution is clear with color being slightly yellow to colorless. Table 3.
Frequently Asked Questions
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 patients being maintained on peritoneal dialysis For treatment of chronic kidney failure. ( 1 )
What are the side effects of Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride?▼
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 .
Can I take Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride during pregnancy?▼
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.
What are the important warnings for Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride?▼
5. Warnings and Precautions Monitor patient for electrolyte, fluid, and nutrition imbalances. ( 5.1 ) Encapsulating Peritoneal Sclerosis (EPS) ( 5.2 ) Peritonitis: Initiate appropriate antimicrobial therapy ( 5.2 ) Monitor for Lactic Acidosis in patients at risk. ( 5.3 ) 5.1 Electrolyte, Fluid and Nutrition Imbalances Peritoneal dialysis may affect a patient's protein, water-soluble vitamin, potassium, sodium, chloride, bicarbonate, and magnesium levels and volume status. Monitor electrolytes and blood chemistry periodically and take appropriate clinical action. Potassium is omitted from DELFLEX solutions because dialysis may be performed to correct hyperkalemia. 4. Contraindications None. None
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.