Dextrose Monohydrate, Sodium Lactate, Potassium Chloride, Magnesium Chloride, Potassium Phosphate, Monobasic, and Sodium Phosphate, Monobasic, Monohydrate for Cholera

INDICATIONS AND USAGE Ionosol MB and 5% Dextrose Injection is indicated for intravenous administration to infants for treatment of dehydration, acidosis, diarrhea, and burns, but only after administration of an initial priming solution: 15 mL of 5% dextrose and 0.45% Sodium Chloride Injection/kg of body weight. In adults, Ionosol MB and 5% Dextrose Injection is indicated postoperatively for intravenous fluid and electrolyte maintenance therapy, with a small amount of carbohydrate calories for reducing catabolism of endogenous protein reserves.

DOSAGE AND ADMINISTRATION The dose is dependent upon the age, weight and clinical condition of the patient. In infants, Ionosol MB and 5% Dextrose Injection is given only after administration of an initial priming solution: 15 mL of half isotonic saline in 5% dextrose and 0.45% Sodium Chloride Injection/kg of body weight, administered to small infants at a maximum rate of 0.8 mL/minute. Infants typically tolerate not more than 150 to 200 mL of Ionosol MB and 5% Dextrose Injection per kg body weight/day. 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. In adults, intravenous infusions of Ionosol MB and 5% Dextrose Injection are given postoperatively, at a rate not greater than 4 mL/minute. Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. See PRECAUTIONS . INSTRUCTIONS FOR USE To Open: Tear outer wrap at notch and remove solution container. Some opacity of the plastic due to moisture absorption during sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. If supplemental medication is desired, follow directions below before preparing for administration. To Add Medication Prepare additive port. Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication. The additive port may be protected by covering with an additive cap. Mix container contents thoroughly. To Administer Attach administration set per manufacturer's instructions. Regulate rate of administration per institutional policy. WARNING: Do not use flexible container in series connections.

WARNINGS Solutions which contain potassium ions should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present. Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. Solutions containing lactate ions should be used with great care, if at all, in patients with metabolic or respiratory alkalosis. The administration of lactate ions should be done with great care in those conditions in which there is an increased level or an impaired utilization of lactate ions, such as severe hepatic insufficiency. The intravenous administration of Ionosol MB and 5% Dextrose Injection 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.

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.