Delflex Neutral Ph
Loading...Delflex Neutral Ph Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
Not for Intravenous Injection.
Use Aseptic Technique.
It is important to mix the buffer (Mini-Bag) and main solutions thoroughly. Administer within 24 hours after mixing. Once solutions are mixed, other prescribed medication(s) may be added prior to administration.
After removing the outerwrap, check for minute leaks by squeezing each of the solution bags firmly. If leaks are found, discard the solution because the sterility may be impaired. (A small amount of moisture may be present inside the outerwrap, which is normal condensation from the sterilization process).
Peritoneal dialysis should be done with great care, in patients with a number of conditions, including disruption of the peritoneal membrane or diaphragm by surgery or trauma, extensive adhesions, bowel distention, undiagnosed abdominal disease, abdominal wall infection, hernias or burns, fecal fistula or colostomy, tense ascites, obesity, large polycystic kidneys, recent aortic graft replacement, lactic acidosis and severe pulmonary disease. When assessing peritoneal dialysis as the mode of therapy in such extreme situations, the benefits to the patient must be weighed against the possible complications.
Solutions containing lactate ion should be used with great care in patients with metabolic or respiratory alkalosis. Lactate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency.
An accurate fluid balance record must be kept and the weight of the patient carefully monitored to avoid over or under hydration with severe consequences, including congestive heart failure, volume depletion and shock.
Excessive use of DELFLEX® peritoneal dialysis solution with 4.25% dextrose during a peritoneal dialysis treatment can result in significant removal of water from the patient.
Stable patients undergoing maintenance peritoneal dialysis should have routine periodic evaluation of blood chemistries and hematologic factors, as well as other indicators of patient status.
Serum calcium levels in patients using low calcium concentrations should be monitored and if found to be low, the peritoneal solution in use should be altered to one with a higher calcium concentration.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
DELFLEX® peritoneal dialysis solutions are indicated in the treatment of chronic renal failure patients being maintained on peritoneal dialysis when nondialytic medical therapy is judged to be inadequate.
History
There is currently no drug history available for this drug.
Other Information
DELFLEX® Neutral pH peritoneal dialysis solutions, (standard, low magnesium and 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. In comparison to conventional peritoneal dialysis solutions, DELFLEX® Neutral pH solutions are formulated to lower levels of glucose degradation products and provide a neutral pH of 7.0 ± 0.4, which is closer to physiologic pH. The osmotic and buffer solutions are stored separately and mixed by the patient prior to use. Composition, calculated osmolarity, pH and ionic concentrations of the mixed solutions are shown in Table 2.
Dextrose, USP, is chemically designated D-glucose monohydrate (C6H12O6•H2O) a hexose sugar freely soluble in water. The structural formula is shown here:
Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl2•2H2O) white fragments or granules freely soluble in water.
Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl2•6H2O) colorless flakes or crystals very soluble in water.
Sodium lactate solution, USP, is chemically designated (CH3CH(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, is chemically designated (H2O).
Hydrochloric acid, and sodium hydroxide may be added for pH adjustment. pH is 7.0 ± 0.4.
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. Since the flexible inner bag is compounded from a specific polyvinyl chloride, water may permeate from the inner bag into the outerwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers.
Nominal glucose degradation product (GDP) levels (immediately following sterilization) in DELFLEX® Neutral pH solution and DELFLEX® solution are reported in Table 1. The clinical relevance of these differences in GDP levels is unknown.
*This is the sum [µmol/L] of the various component GDPs including: formaldehyde, acetaldehyde, furaldehyde, glyoxal, methylglyoxal 5-hydroxymethylfurfural (5-HMF), and 3 deoxyglucosone (3DG).
Table 2. Composition, Calculated Osmolarity, pH, and Ionic Concentration
5 Liter DELFLEX® Neutral pH 6 Liter DELFLEX® Neutral pH
Sources
Delflex Neutral Ph Manufacturers
-
Fresenius Medical Care North America
![Delflex Neutral Ph (Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate) Solution [Fresenius Medical Care North America]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Delflex Neutral Ph | Fresenius Medical Care North America
DELFLEX® peritoneal dialysis solutions are provided for intraperitoneal administration only. 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.
To avoid the risk of severe dehydration or hypovolemia and to minimize the loss of protein, it is advisable to select the peritoneal dialysis solution with lowest level of osmolarity consistent with the fluid removal requirements for that exchange.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Additives may be incompatible. Do not store solutions containing additives.
For administration see Directions for Use section.
-
Fresenius Medical Care North America
Delflex Neutral Ph | Fresenius Medical Care North America
DELFLEX® peritoneal dialysis solutions are provided for intraperitoneal administration only. 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.
To avoid the risk of severe dehydration or hypovolemia and to minimize the loss of protein, it is advisable to select the peritoneal dialysis solution with lowest level of osmolarity consistent with the fluid removal requirements for that exchange.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Additives may be incompatible. Do not store solutions containing additives.
For administration see Directions for Use section.
-
Fresenius Medical Care North America
Delflex Neutral Ph | Fresenius Medical Care North America
DELFLEX® peritoneal dialysis solutions are provided for intraperitoneal administration only. 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.
To avoid the risk of severe dehydration or hypovolemia and to minimize the loss of protein, it is advisable to select the peritoneal dialysis solution with lowest level of osmolarity consistent with the fluid removal requirements for that exchange.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Additives may be incompatible. Do not store solutions containing additives.
For administration see Directions for Use section.
-
Fresenius Medical Care North America
Delflex Neutral Ph | Fresenius Medical Care North America
DELFLEX® peritoneal dialysis solutions are provided for intraperitoneal administration only. 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.
To avoid the risk of severe dehydration or hypovolemia and to minimize the loss of protein, it is advisable to select the peritoneal dialysis solution with lowest level of osmolarity consistent with the fluid removal requirements for that exchange.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Additives may be incompatible. Do not store solutions containing additives.
For administration see Directions for Use section.
![Delflex Neutral Ph (Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate) Solution [Fresenius Medical Care North America]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6da01480-39a9-11e2-b5eb-0002a5d5c51b&name=delflex-figure-17.jpg)
![Delflex Neutral Ph (Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate) Solution [Fresenius Medical Care North America]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=637727c1-29bc-11e2-81c1-0800200c9a66&name=delflex-nph-single-bag-pdp-1.jpg)
![Delflex Neutral Ph (Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate) Solution [Fresenius Medical Care North America]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=251f0061-e7ae-11e1-aff1-0800200c9a66&name=delflex-figure-17.jpg)
Login To Your Free Account