Product Elements:
Dextrose dextrose monohydrate dextrose monohydrate anhydrous dextrose water
Indications and Usage:
Indications and usage intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient. in this dosage form, 5% dextrose injection, usp is intended to be used as a diluent for the contents of an add-vantage vial, or single-dose vials with 20 mm closure using the add-vantage addaptor tm .
Warnings:
Warnings excessive administration of potassium-free solutions may result in significant hypokalemia. the intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. the risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. the risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.
Dosage and Administration:
Dosage and administration the dose is dependent on the age, weight and clinical condition of the patient. as reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. see precautions .
Contraindications:
Contraindications dextrose injection without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.
Adverse Reactions:
Adverse reactions reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. if an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
Overdosage:
Overdosage in the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. see warnings , precautions , and adverse reactions .
Description:
Description 5% dextrose injection, usp solution is sterile and nonpyrogenic. it is a parenteral solution containing 50 mg/ml of dextrose, hydrous in water for injection and is intended for intravenous administration after admixing with an add-vantage vial, or single-dose powdered drug vials with 20 mm closure using the add-vantage addaptor tm (warning: do not use with chemotherapy agents) . the solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. when smaller doses are required the unused portion should be discarded. the solution is slightly hypotonic (253 mosmol/liter; calc.) in relation to the extracellular fluid (approx. 280 mosmol/liter). the ph of the solution is 4.3 (3.2 - 6.5). the solution is a parenteral fluid and nutrient replenisher. dextrose, usp is chemically designated d-glucose, monohydrate (c 6 h 12 o 6 ⢠h 2 o), a hexose sugar freely soluble in water. it has the following structural formula: water for injection, usp is chemically designated h 2 o. the flexible plastic container is fabricated from a specially formulated polyvinylchloride. water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. 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. structural formula dextrose
Clinical Pharmacology:
Clinical pharmacology when administered intravenously, this solution provides a source of water and carbohydrate. solutions containing carbohydrate in the form of dextrose restore blood glucose levels and provide calories. carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. dextrose injected parenterally undergoes oxidation to carbon dioxide and water. water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. average normal adult daily requirements range from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). water balance is maintained by various regulatory mechanisms. water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (na + ) plays a major role in maintaining physiologic equilibrium.
How Supplied:
How supplied 5% dextrose injection, usp is supplied in single-dose flexible plastic add-vantage tm diluent containers. store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] unit of sale volume ndc 0409-7100-66 case of 50 â 50 ml bags 50 ml bags ndc 0409-7100-67 case of 50 â 100 ml bags 100 ml bags ndc 0409-7100-02 case of 24 â 250 ml bags 250 ml bags instructions for use with add-vantage vial these instructions for use should be made available to the individuals who perform the reconstitution steps. to open: peel overwrap at corner and remove solution container. use unit within 30 days of opening overwrap, as long as the use date does not exceed the printed expiration date. some opacity of the plastic due to moisture absorption during the sterilization process may be observed. this is normal and does not affect the solution quality or safety. the opacity will diminish gradually. to assemble vial and flexible diluent container: (use aseptic techni
Read more...que) 1. remove the protective covers from the top of the vial and the vial port on the diluent container as follows: a. to remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (see figure 1.), then pull straight up to remove the cap. (see figure 2.) note: once the breakaway cap has been removed, do not access vial with syringe. fig. 1 fig. 2 b. to remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (see figure 3.) 2. screw the vial into the vial port until it will go no further. the vial must be screwed in tightly to assure a seal. this occurs approximately 1/2 turn (180°) after the first audible click. (see figure 4.) the clicking sound does not assure a seal; the vial must be turned as far as it will go. note: once vial is seated, do not attempt to remove. (see figure 4.) 3. recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly. 4. label appropriately. fig. 3 fig. 4 to reconstitute the drug: 1. squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial. 2. with the other hand, push the drug vial down into the container telescoping the walls of the container. grasp the inner cap of the vial through the walls of the container. (see figure 5.) 3. pull the inner cap from the drug vial. (see figure 6.) verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix. 4. mix container contents thoroughly and use within the specified time. 5. look through the bottom of the vial to verify that the stopper has been removed and complete mixing has occurred. (see figure 7.) if the rubber stopper is not removed from the vial and medication is not released on the first attempt, the inner cap may be manipulated back into the rubber stopper without removing the drug vial from the diluent container. repeat steps 3 through 5. fig. 5 fig. 6 fig. 7 preparation for administration: (use aseptic technique) 1. confirm the activation and admixture of vial contents. 2. check for leaks by squeezing container firmly. if leaks are found, discard unit as sterility may be impaired. 3. close flow control clamp of administration set. 4. remove cover from outlet port at bottom of container. 5. insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. note: see full directions on administration set carton. 6. lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. bend the loop outward to lock it in the upright position, then suspend container from hanger. 7. squeeze and release drip chamber to establish proper fluid level in chamber. 8. open flow control clamp and clear air from set. close clamp. 9. attach set to venipuncture device. if device is not indwelling, prime and make venipuncture. 10. regulate rate of administration with flow control clamp. warning: do not use flexible container in series connections. instructions for use with add-vantage addaptor tm the instructions for use provided with the add-vantage addaptor tm should be made available to the individuals who perform the reconstitution steps. distributed by hospira, inc., lake forest, il 60045 usa lab-1143-3.0 revised: 09/2021 figure 1 figure 2 figure 3 figure 4 figure 5 figure 6 figure 7 hospira logo
Package Label Principal Display Panel:
Principal display panel - 50 ml bag label pull inner plug/stopper and mix drug before use add-vantage⢠unit ndc 0409-7100-68 5% dextrose injection, usp 50 ml each 100 ml contains dextrose, hydrous 5 g. 253 mosmol/liter (calc.). ph 4.3 (3.2 to 6.5) dextrose solutions without salts should not be used in blood transfusions because of possible rouleau formation. for use only with add-vantage⢠system components. single- dose container. for iv use. usual dosage: see package insert. sterile, nonpyrogenic. use only if solution is clear and container is undamaged. must not be used in series connections. distributed by hospira, inc., lake forest, il 60045 usa rx only im-4480 14475201 3 v contains dehp principal display panel - 50 ml bag label
Principal display panel - 100 ml bag label pull inner plug/stopper and mix drug before use add-vantage⢠unit ndc 0409-7100-69 5% dextrose injection, usp 100 ml each 100 ml contains dextrose, hydrous 5 g. 253 mosmol/liter (calc.). ph 4.3 (3.2 to 6.5) dextrose solutions without salts should not be used in blood transfusions because of possible rouleau formation. for use only with add-vantage⢠system components. single-dose container. for iv use. usual dosage: see package insert. sterile, nonpyrogenic. use only if solution is clear and container is undamaged. must not be used in series connections. distributed by hospira, inc., lake forest, il 60045 usa rx only im-4481 14475601 3 v contains dehp principal display panel - 100 ml bag label
Principal display panel - 250 ml bag label lot exp. pull inner plug/stopper and mix drug before use add-vantage⢠unit ndc 0409-7100-04 5% dextrose injection, usp 250 ml each 100 ml contains dextrose, hydrous 5 g. 253 mosmol/liter (calc). ph 4.3 (3.2 to 6.5) dextrose solutions without salts should not be used in blood transfusions because of possible rouleau formation. for use only with add-vantage⢠system components. single- dose container. for intravenous use. usual dosage: see insert. sterile, nonpyrogenic. use only if solution is clear and container is undamaged. must not be used in series connections. rx only distributed by hospira, inc., lake forest, il 60045 usa hospira 3 v contains dehp im-4482 14475801 principal display panel - 250 ml bag label
Principal display panel - overwrap â wr-0583 one/add-vantage⢠unit to openâpeel at corner for use only with add-vantage⢠system components. the overwrap is a moisture barrier. use unit within 30 days of opening overwrap, as long as the use date does not exceed the printed expiration date. store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] protect from freezing. see insert. after removing the overwrap, check for minute leaks by squeezing container firmly. if leaks are found, discard unit as sterility may be impaired. rx only 14475901 distributed by hospira, inc., lake forest, il 60045 usa hospira wr-0583 principal display panel - overwrap â wr-0583
Principal display panel - overwrap â wr-0581 to open â peel at notch five/add-vantage⢠units for use only with add-vantage⢠system components. the overwrap is a moisture barrier. use units within 30 days of opening overwrap, as long as the use date does not exceed the printed expiration date. after removing the overwrap, check for minute leaks by squeezing container firmly. if leaks are found, discard unit as sterility may be impaired. store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] rx only 14475301 distributed by hospira, inc., lake forest, il 60045 usa hospira wr-0581 principal display panel - overwrap â wr-0581