The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
DESCRIPTION:5% dextrose solution is sterile, non-pyrogenic for fluid and calorie replacement, and is supplied in single-dose containers for intravenous administration. Discard the unused portion. Does not contain antimicrobial agents. Chemically, dextrose (glucose) is a monosaccharide containing an aldehyde group (an aldose). In water it exists primarily as a six membered hemi-acetal ring in equilibrium with a minor amount of the free aldehyde form and a five membered hemiacetal form. Dextrose used is either an anhydrous or monohydrate form. The Plastic container, a semi-rigid bottle, is made of a low-density polyethylene which is a flexible and resistant material. No venting is necessary during infusion.COMPOSITION:Each 100mL containsDextrose monohydrate 5.50g equivalent 5g dextrose; Water for injection q. s.Total osmolarity Calc is 278 milliosmoles per literP.H. 3.2-6.5
CLINICAL PHARMACOLOGY:5% Dextrose solution has value as a source of water and calories. It is capable of inducing diuresisdepending on the clinical condition of the patient. Glucose is a nutrient of the first order, provides 4.1 Kcal per gram and like all carbohydrates has the property of decreasing protein catabolism
INDICATIONS AND USAGE:5% dextrose solution is indicated as a source of water and calories. It is used to decrease the excessive pressure of spinal brain fluid, also as sclerosing to treat varicose veins and decrease intracranial pressure
WARNING:5% Dextrose Injection should not be administered simultaneously with blood through the sameadministration set because of the possibility of pseudoagglutination or hemolysis. The intravenous administration of 5% Dextrose Injection can cause fluid and/or solute overloadingresulting in dilution of serum electrolyte concentrations, over hydration, congested states, or pulmonary edema. The risk of dilutive states is inversely proportional to the electrolyte concentrations of the injections.The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections. Excessive administration of dextrose injections may result in significant hypokalemia.
ADVERSE REACTIONS:Reactions which may occur because of the injection 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.
PRECAUTIONS:Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. 5% Dextrose Injection should be used with caution in patients with overt or subclinical diabetes mellitus. Do not administer unless solution is clear and seal is intact. This is a hypotonic solution and as such should not be used for resuscitation
OVERDOSAGE:In an event of over hydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See Warnings, Precautions, and Adverse Reactions.
Dosage & Administration
DOSAGE AND ADMINISTRATION:As directed by a veterinarian. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. All injections in plastic containers are intended for intravenous administration using sterile equipment. Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with veterinarian, if available. If, in the informed judgment of the veterinarian, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.
- DIRECTIONS FOR USE PLASTIC CONTAINER:To OpenCheck for minute leaks by squeezing the container firmly. If leaks are found, discard solution as sterility may be impaired. Use the solution immediately after the bottle is opened, discard the remaining one. Discard unused portion. If supplemental medication is desired follow directions below:Preparation and administrationCheck for minute leaks by squeezing the container firmly. If leaks are found, discard solution as sterility may be impaired.Suspend container from eyelet supportRemove Plastic protector from ports area at the bottom of container.Hold the bottle in vertical position and inset pyrogen free IV administration set in the outlet port. Use aseptic TechniqueTo Add MedicationWARNING: Additives may be incompatible.To add medication before solution administration1. Prepare medication site.2. Using syringe with 19 to 22 gauge needle, puncture inlet port and inject.3. Mix solution and medication thoroughly.To add medication during solution administration1. Close clamp on the set.2. Prepare medication site.3. Using syringe with 19 to 22 gauge needle, puncture inlet port and inject.4. Remove container from IV pole and/or turn to an upright position.5. Mix solution and medication thoroughly.6. Return container to in use position and continue administration.
Storage And Handling
STORAGE:Store at temperatures no higher than 30ºC (86ºF)Keep out of the reach of children
Information For Owners/Caregivers
Manfactured by:LABORATORIOS ALFA S.R.L.,Santo Domingo, Dominican RepublicRevised October 2019