FDA label 3170d1ee-c6ca-5c35-e063-6294a90a5f04

Administration of intravenous solutions may lead to fluid and/or solute overload, which may cause dilution of serum electrolyte concentration, overhydration, congestive states, or pulmonary edema. The risk of dilution is inversely proportional to the electrolyte concentration. The risk of developing congestive states that may lead to peripheral and pulmonary edema is directly proportional to the electrolyte concentration in the solution. The solution contains 154 mmol/l sodium (Na+) and 154 mmol/l chloride (Cl-); its osmolarity is approximately 308 mOsm/l, and its pH is 5.5 (4.5 - 7.0). Careful clinical monitoring is required at the beginning of all intravenous infusions. Applications should be carried out under regular and careful observation. Clinical and biological parameters, especially serum electrolyte levels, should be monitored. Sodium retention may be observed in premature or full-term newborn babies, since their renal functions are not yet fully developed. Therefore, repeated sodium chloride infusions should be given to newborn babies only after serum sodium levels have been determined. Solutions containing sodium should be used with caution in cases of hypertension, heart failure, peripheral or pulmonary edema or impaired renal function, in cases of preeclampsia, in cases of aldosteronism, or in other conditions and treatments that cause sodium retention (e.g., corticosteroid therapy). Pseudohyponatremia is a condition in which plasma sodium is falsely low when measured by conventional methods, even though it is not actually low. It can occur when large molecules are in abnormally high concentrations and the plasma water ratio is abnormally low as a result. This condition, which can be seen in hyperlipemia and hyperproteinemia, has also been reported to be seen in patients with diabetes mellitus. Real values ​​can be obtained by evaluating the concentration according to the plasma water ratio. Excessive application of potassium-free solutions can lead to a significant hypokalemia. Serum potassium levels should be maintained at normal levels and potassium should be added to the treatment if necessary. In order to minimize the risk of incompatibility with any other drug added to the solution, the final mixture to be infused should be checked for any turbidity or precipitation immediately after mixing, before administration and at certain intervals during administration. If the application is to be made with a controlled infusion pump, care should be taken to ensure that the pump is stopped before the bag is completely emptied, otherwise air embolism may occur. The solution is administered intravenously through sterile sets. It is recommended that sets used for intravenous administration be changed every 24 hours. It should only be used if the solution is clear and the bag is intact and not leaking. Laboratory tests: In long-term parenteral administration or when the patient's condition requires, clinical evaluation and periodic laboratory tests should be performed to monitor changes in the patient's fluid balance, electrolyte concentrations, and acid-base balance. When significant deviations from normal values ​​are observed, these values ​​should be normalized with alternative solutions. Warnings and precautions regarding pediatric use: Fluid and electrolyte balance in neonates or very young infants can be affected by even the administration of very small amounts of fluid. Care should be exercised in the treatment of neonates, especially preterm neonates, whose renal functions are not yet fully developed and whose ability to excrete solutes with fluids is limited. Fluid intake, urine output, and serum electrolyte levels should be closely monitored. Warnings and precautions regarding use in the elderly: In general, the dose should be selected carefully in elderly patients. Considering that the liver, kidney or cardiac functions may be reduced in the elderly, other drugs may be used together or there may be diseases other than the condition being treated, it is generally recommended to start treatment with doses at the bottom of the dosage range.

To report suspected adverse reactions" and "1-800-332-1088" (different telephone number for documents of type Vaccine Label (53404-0) Under normal treatment conditions, no undesirable effects are expected. Undesirable effects may be due to a deficiency or excess of ions in the solution; therefore, sodium and chloride levels should be closely monitored. It is also necessary to be aware that additional drugs administered in diluted form may also cause adverse effects. In such a case, the product information of the additional drug administered should be consulted. Inadvertent application of intravenous sodium chloride therapy (e.g., in the postoperative period, in patients with heart or kidney failure) may lead to hypernatremia. Osmotically induced water movement may reduce intracellular volume, leading to dehydration of internal organs, especially the brain, and thrombosis and hemorrhage. When any addition is made to isotonic solutions that make the solution hypertonic, if the application is made subcutaneously, pain may occur at the injection site. When large volumes are administered, sodium accumulation, edema and hyperchloremic acidosis may occur. If an adverse reaction is observed during administration, the infusion should be stopped, the patient's condition should be evaluated and appropriate treatment measures should be taken. Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from available data) The following adverse reactions are effects that may be seen as a result of excess sodium or chloride due to overdose or may develop depending on the application technique. The frequency of these adverse reactions is unknown (they may be seen in too few patients to be determined with the available data). Blood and lymphatic system disorders Not known:Thrombosis; Hemorrhage. Metabolism and nutritional disorders Not known: Sodium retention; Water retention and edema; Aggravation of congestive heart failure (due to hypernatremia); Hyperchloremic acidosis. Nervous system disorders Not known: Headache, dizziness, restlessness, irritation, convulsions, coma and death (cerebral dehydration due to hypernatremia). Cardiac disorders Not known: Tachycardia (due to hypernatremia). Vascular disorders Not known: Hypertension (due to hypernatremia). Respiratory, thoracic and mediastinal disorders Not known: Pulmonary edema, respiratory depression and respiratory arrest (due to hypernatremia). Gastrointestinal disorders Not known: Nausea, vomiting, diarrhea, abdominal cramps, thirst, decreased salivation (due to hypernatremia). Skin and subcutaneous tissue disorders Not known: Decreased sweating (due to hypernatremia). Musculoskeletal disorders, connective tissue and bone disorders Not known: Muscle twitching and stiffness (due to hypernatremia). Kidney and urinary disorders Unknown: Renal failure (due to hypernatremia). General disorders and diseases related to the application site Unknown: Fever; Weakness (due to hypernatremia); Pain at the injection site (due to subcutaneous administration of a solution made hypertonic by adding it into it). Surgical and medical procedures Unknown: Febrile reactions; Injection site infection; Venous thrombosis or phlebitis starting at the injection site and spreading; Extravasation and hypervolemia (adverse reactions that may be seen depending on the application technique). Reporting of suspected adverse reactions Reporting of suspected adverse reactions to drugs after authorization is of great importance. Reporting allows for continuous monitoring of the benefit/risk balance of the drug. Healthcare professionals should report any suspected adverse reactions to the Turkish Pharmacovigilance Center (TÜFAM) (www.titck.gov.tr; e-mail: tufam@titck.gov.tr; tel: 0 800 314 00 08; fax: 0 312 218 35 99).