FDA label 31d5a70d-d1fe-a5cd-e063-6394a90ac2f9

Special warnings and precautions for use Hypersensitivity reactions If any signs or symptoms suggestive of a hypersensitivity reaction occur during administration, the infusion should be stopped immediately. Appropriate therapeutic interventions should be implemented as clinically indicated. Incompatibilities Ceftriaxone: In patients older than 28 days, including adults, ceftriaxone should not be used simultaneously with calcium-containing solutions, including TURKFLEKS LACTATED RINGER, through the same infusion line. If the same administration set is to be used for successive applications, the set should be thoroughly rinsed with compatible solutions before administration. For the use of TURKFLEKS LACTATED RINGER with ceftriaxone in newborn infants younger than 28 days, see “4.3. Contraindications”. Electrolyte balance Hypernatremia: In cases of hypernatremia, TURKFLEKS LACTATED RINGER should only be used after careful investigation of the cause of the underlying disease and in cases where alternative intravenous fluid treatments cannot be applied. In such cases, it is recommended to monitor plasma sodium levels and plasma volume and apply. TURKFLEKS LACTATED RINGER should be applied with special care in cases that increase the tendency to hypernatremia (such as adrenocortical insufficiency, diabetes insipidus or widespread tissue damage) and in patients with cardiac disease. Hyperchloremia: In cases of hyperchloremia, TURKFLEKS LACTATED RINGER should be used only after the cause of the underlying disease has been carefully investigated and in cases where alternative intravenous fluid treatments cannot be applied. In such cases, it is recommended to apply by monitoring plasma chloride levels and plasma acid-base balance. TURKFLEKS LACTATED RINGER should be administered with special care in conditions that increase the tendency to hyperchloremia (such as renal failure and renal tubular acidosis, diabetes insipidus), in patients who have undergone urinary diversion or who are taking certain diuretics (such as carbonic anhydrase inhibitors such as acetazolamide) or steroids (androgens, estrogens, corticosteroids), and in patients with severe dehydration. Use in patients with potassium deficiency: Although the amount of potassium in the composition of TURKFLEKS LACTATED RINGER is similar to that of plasma, the solution should not be used for this purpose, as it is not at a level that will have a beneficial effect in cases of severe potassium deficiency. Use in patients at risk of hyperkalemia: TURKFLEKS LACTATED RINGER should be applied with special care in conditions that increase the tendency to hyperkalemia (such as severe renal failure or adrenocortical insufficiency, acute dehydration or widespread tissue damage or burns) and in patients with cardiac disease. It is recommended to closely monitor plasma potassium levels in patients at risk of hyperkalemia. Use in patients at risk of hypercalcemia: Calcium chloride is an irritant; therefore, care should be taken not to leak solution out of the vein when administered intravenously or intramuscularly. Solutions containing calcium salts should be used with caution in patients with impaired renal function or high vitamin D levels, such as sarcoidosis. In addition, it should be avoided in patients with a history of calcium stones in the kidneys. Fluid balance / kidney functions Use in patients with impaired renal function: TURKFLEKS LACTATED RINGER should be administered with special care to patients with impaired renal function. In such patients, administration of TURKFLEKS LACTATED RINGER may cause sodium and/or potassium accumulation. Use in patients at risk of fluid and/or solute overload and electrolyte disturbances: Depending on the volume administered and the rate of administration, intravenous administration of TURKFLEKS LACTATED RINGER may cause the following conditions: - Fluid and/or solute overload leading to overhydration and congestive conditions (including pulmonary congestion and edema). - Clinically relevant electrolyte disturbances and acid-base imbalance. During long-term parenteral administration, the patient's clinical condition and laboratory parameters should be monitored at regular intervals whenever the patient's condition or the rate of intravenous fluid administration requires it. High-volume infusions should be administered with special monitoring in patients with heart or lung failure. Use in patients with hypervolemia, overhydration or conditions that lead to sodium retention and edema: TURKFLEKS LACTATED RINGER should be administered with special caution in patients with hypervolemia or overhydration. TURKFLEKS LACTATED RINGER should be administered with special caution in patients with primary hyperaldosteronism, secondary hyperaldosteronism (e.g. hypertension, congestive heart failure, renal artery stenosis or nephrosclerosis) or conditions that may lead to sodium retention, fluid overload and edema such as preeclampsia due to its sodium chloride content (See Section 4.5.). Acid-base balance Use in patients at risk of alkalosis: TURKFLEKS LACTATED RINGER should be administered with special care in patients at risk of alkalosis. Since lactate is metabolized to bicarbonate, the solution may cause metabolic alkalosis in such patients or may aggravate an existing metabolic alkalosis. Although convulsions may be induced in lactate-induced alkalosis, this is not a common condition. Other warnings Application with citrate anticoagulated/stored blood: Due to the calcium it contains, it is not recommended to add TURKFLEKS LACTATED RINGER to citrate anticoagulated/stored blood, to citrate anticoagulated/stored blood, to administer simultaneously or to administer together from the same infusion system. Use in patients with type 2 diabetes: Lactate is a substrate for gluconeogenesis. This should be taken into consideration when using TURKFLEKS LACTATED RINGER in patients with type 2 diabetes. Warnings regarding administration: Addition of additional drugs according to the procedure or failure to perform the application with appropriate techniques may lead to fever reactions due to pyrogen contamination. In such a case, the infusion should be stopped immediately. Please see Sections 6.2 and 6.6 regarding incompatibilities of the solution and addition of additional drugs to the product. During long-term parenteral therapy, the patient should be given appropriate nutritional support.

Listed below are adverse reactions reported spontaneously in post-marketing experience. Adverse reactions are listed according to the MedDRA System Organ Classification. The following terminology is used when reporting frequency: 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, including isolated reports (<1/10,000); not known (cannot be estimated from available data). Immune system disorders Not known: Hypersensitivity/infusion reactions (including anaphylactic/anaphylactoid reactions) with one or more of the following symptoms: angioedema, chest pain, chest discomfort, decreased heart rate, tachycardia, decreased blood pressure, respiratory distress, bronchospasm, dyspnea, cough, urticaria, rash, pruritus, erythema, flushing of the face and/or neck, throat irritation, paresthesia, hypoesthesia of the mouth, dysgeusia, nausea, anxiety, pyrexia, and headache. Metabolism and nutritional disorders Not known: Hyperkalemia. General disorders and administration site conditions Not known: Infusion site reactions, which may be seen with one or more of the following symptoms: Phelbitis, inflammation at the infusion site, swelling, rash, pruritus, erythema, pain and burning sensation. The following is a list of adverse reactions that have been spontaneously reported during the use of other sodium lactate-containing solutions: Immune system disorders Not known: Hypersensitivity reactions: Laryngeal edema (Quincke edema), skin swelling, nasal congestion, sneezing/sneezing. Metabolism and nutritional disorders Unknown: Electrolyte disorders. Psychiatric disorders Unknown: Anxiety. Vascular disorders Unknown: Hypervolemia. General disorders and administration site conditions Unknown: Other infusion site reactions: infusion site infection, extravasation, infusion site anesthesia (numbness). Reporting of suspected adverse reactions Reporting of suspected adverse reactions to drugs after licensing is of great importance. Reporting allows 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).