Electrolyte rehydration solution Baxter

Italy
Brand name Electrolyte rehydration solution Baxter
Form solution for infusion
Active substance / Dosage
POTASSIUM CHLORIDE
SODIUM CHLORIDE
SODIUM LACTATE
Prescription type Prescription only
ATC code
B05BB01
Registration number 030918
Manufacturer BAXTER S.P.A.

Table of Contents

Baxter SpA Electrolyte Rehydration I

PACKAGE LEAFLET

ELECTROLYTE REHYDRATING BAXTER

I Infusion Solution
EQUIVALENT MEDICINE
Pharmacotherapeutic Category
Electrolytes
Therapeutic Indications
Rehydration and replacement of fluids and electrolytes. Treatment of mild to moderate, but not severe, metabolic acidosis.
Contraindications

  • Known hypersensitivity to the active substances or to any of the excipients;
  • Severe renal failure;
  • Hypernatremia;
  • Hydro-saline plethora;
  • Hyperkalemia or conditions involving potassium retention;
  • Untreated Addison's disease;
  • Acute dehydration;
  • Heat cramps;
  • Lactic acidosis;
  • Impaired oxidative processes preventing lactate utilization (e.g., shock, hypoxemias);
  • Metabolic and respiratory alkalosis.

Precautions for Use
Use in patients with hypervolemia or hyperhydration, or conditions causing sodium retention and edema
Due to its sodium content, use with caution in patients with congestive heart failure, severe renal failure, and clinical conditions associated with edema and hydro-saline retention; in patients receiving cardiac inotropic drugs or corticosteroid or corticotropin drugs.
The medicine must be administered cautiously in hypervolemic or hyperhydrated patients.
The medicine must be administered with particular caution in patients with conditions that may cause sodium retention, fluid overload, and edema, such as primary hyperaldosteronism, secondary hyperaldosteronism (e.g., associated with hypertension, congestive heart failure, renal artery stenosis, or nephrosclerosis), peripheral or pulmonary edema, reduced renal function, pre-eclampsia, or other conditions associated with sodium retention (see Interactions).
Use in patients with or at risk of hyperkalemia
Baxter SpA Electrolyte Rehydrating I
The medicine must be administered with particular care to patients with conditions predisposing to hyperkalemia (such as severe renal impairment or adrenocortical insufficiency, acute dehydration, or extensive tissue damage or burns) and in patients with cardiac disorders.
Due to its potassium content, administration should be guided by serial electrocardiograms; serum potassium levels do not reflect intracellular potassium concentrations. High plasma potassium concentrations may cause death due to cardiac depression, arrhythmias, or cardiac arrest. To avoid potassium intoxication, the infusion must be slow.
The medicine must be administered with caution in patients:

  • With renal failure (administration of potassium-containing solutions in patients with reduced renal function may cause potassium retention);
  • With heart failure, especially if digitalized;
  • With adrenal insufficiency;
  • With hepatic insufficiency;
  • With familial periodic paralysis;
  • With congenital myotonia;
  • In the early postoperative phase. During infusion of the medicine, continuous ECG monitoring is essential, and it is good practice to monitor fluid balance, electrolytes, plasma osmolarity, and acid-base balance. Risk of gaseous embolism Do not use plastic containers connected in series, as they may cause gaseous embolism due to possible residual air from the primary container. Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates may cause gaseous embolism if residual air in the container is not completely removed before administration. Using an intravenous administration set with the vent in the open position may cause gaseous embolism. Intravenous administration sets with the vent in the open position must not be used with flexible plastic containers. Use in patients with type 2 diabetes Lactate is a substrate for gluconeogenesis. This should be taken into account when the medicine is used in patients with type 2 diabetes. Use in patients with or at risk of elevated lactate levels or impaired lactate utilization The medicine must be used with particular caution in patients with conditions associated with elevated lactate levels or impaired lactate utilization, such as severe hepatic insufficiency. Hyperlactatemia may develop in patients with severe hepatic insufficiency, as lactate metabolism may be impaired. Additionally, since lactate metabolism may be compromised, the medicine may fail to exert its alkalinizing effect in patients with severe hepatic insufficiency (see also Use in pediatric patients). Use in pediatric patients The safety and efficacy of the medicine in children have not been established by adequate and well-controlled studies.

Baxter SpA Electrolyte Rehydrating I
Solutions containing lactate must be administered with particular caution to neonates and infants under 6 months of age.
Use in elderly patients
When selecting the type of infusion solution and the volume/infusion rate for elderly patients, consider that elderly patients generally have a higher likelihood of cardiac, renal, hepatic, or other diseases or concomitant therapies.
Interactions
Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription.
Caution is advised when administering the medicine to patients treated with drugs whose renal elimination depends on pH. Due to its alkalinizing effect (bicarbonate formation), the medicine may interfere with the elimination of such drugs:

  • Renal clearance of acidic drugs such as salicylates, barbiturates, and lithium may be increased;
  • Renal clearance of basic drugs such as sympathomimetics (e.g., ephedrine, pseudoephedrine), quinidine, or dextroamphetamine sulfate may be decreased. Due to its potassium content, the medicine must be administered with caution in patients treated with agents or products that may cause hyperkalemia or increase its risk, such as potassium-sparing diuretics (amiloride, spironolactone, triamterene), especially in the presence of renal dysfunction. Therefore, in such cases, serum potassium levels must be closely monitored. The use of drugs such as ACE inhibitors, which reduce aldosterone levels, may lead to potassium retention. Therefore, serum potassium levels must be closely monitored. Due to its potassium content and the risk of hyperkalemia, administer with caution also in patients treated with angiotensin II receptor antagonists or immunosuppressants such as tacrolimus and cyclosporine. Potassium administration in patients treated with these drugs may cause severe and potentially fatal hyperkalemia, particularly in patients with severe renal failure. Caution is advised when administering the medicine to patients treated with drugs that may increase the risk of sodium and water retention, leading to edema and hypertension, such as corticosteroids, cardiac inotropic agents, or corticotropin drugs (see Precautions for Use).

Special Warnings
The medicine is not indicated for the treatment of hypochloremic hypokalemic alkalosis and must be used with caution in patients with hypochloremic hypokalemic alkalosis (e.g., due to prolonged vomiting, pyloric stenosis, prolonged nasogastric suction).
Hypersensitivity reactions
Hypersensitivity/infusion reactions, including anaphylactoid reactions, have been reported with other electrolyte-containing solutions.
Infusion must be stopped immediately if any sign or symptom of suspected hypersensitivity occurs. Appropriate therapeutic countermeasures must be instituted as clinically indicated.
Baxter SpA Electrolyte Rehydrating I
Risk of fluid and/or solute overload and electrolyte imbalances
Depending on the volume and rate of infusion, intravenous administration of the medicine may cause:

  • fluid overload leading to hyperhydration/hypervolemia and, for example, congestive states, including pulmonary congestion and edema
  • clinically significant electrolyte imbalances and acid-base imbalance (see also Use in pediatric patients) In general, the risk of dilutional states is inversely proportional to the electrolyte concentrations of the medicine. The risk of solute overload that may cause congestive states is directly proportional to the electrolyte concentrations of the medicine. Clinical evaluation and periodic laboratory tests may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or in any case where the patient's condition or rate of administration requires such evaluation. Risk of hyponatremia - Pediatric population Plasma electrolyte concentrations must be carefully monitored in the pediatric population, as this population may have a reduced capacity to regulate fluids and electrolytes. Infusion of hypotonic fluids together with non-osmotic ADH secretion may cause hyponatremia. Hyponatremia may cause headache, nausea, seizures, lethargy, coma, cerebral edema, and death. Therefore, severe symptomatic hyponatremic encephalopathy is considered a medical emergency. Use in patients with hypocalcemia The medicine does not contain calcium, and an increase in plasma pH due to its alkalinizing effect may lower ionized calcium concentration (not protein-bound). The medicine must be used with particular caution in patients with hypocalcemia. Use in patients with hypomagnesemia The medicine does not contain magnesium, and an increase in plasma pH due to its alkalinizing effect may lower ionized magnesium concentration (not protein-bound). The medicine must be used with particular caution in patients with hypomagnesemia. Use immediately after opening the container. The solution must be clear, colorless, and free from visible particles. It is intended for single, uninterrupted administration, and any residual solution must not be used.

Pregnancy and Breastfeeding
There are no data available on possible adverse effects of the medicine when administered during pregnancy or breastfeeding or on reproductive capacity.
Therefore, the medicine must not be used during pregnancy and breastfeeding unless absolutely necessary and only after evaluating the risk/benefit ratio.
Effects on the ability to drive and use machinery
The medicine does not affect the ability to drive or use machinery.
Baxter SpA Electrolyte Rehydrating I
Dosage, Route, and Duration of Administration
The solution is isotonic with blood and must be administered by intravenous infusion with caution and at a controlled infusion rate.
Shake well during preparation and before use.
The dosage, rate, and duration of administration must be individualized and depend on the patient's age, weight, clinical condition, concomitant treatment, and clinical and laboratory response to therapy.
The medicine must be administered with caution only in patients with intact renal function and at a rate not exceeding 10 mEq potassium/hour.
Adults
Generally, the dose is 2 liters/day, administered at an infusion rate of approximately 300 ml/hour.
Children
In children, the safety and efficacy of the medicine have not been determined.
Administration must be stopped if the patient experiences pain or redness at the injection site, as this may indicate extravasation of the drug.
Infusions that are too rapid may cause local pain, and the infusion rate must be adjusted according to tolerance.
It is advisable for the patient to remain lying down for a short period after administration.
Use the solution immediately after opening the container. It is intended for single, uninterrupted administration, and any residual solution must not be used.
Shake well before administration. Parenteral medicines must be visually inspected for particles and discoloration when the solution and container permit. Do not use the medicine if the solution is not clear and colorless, contains particles, or if the seal is not intact.
Adopt all usual precautions to maintain sterility before and during intravenous infusion.
If used to dilute medicines, consult the pharmacist if possible before adding additive drugs; consider the characteristics of the products to be added; when adding additive drugs, use aseptic techniques.
Additive drugs may be incompatible with the medicine. As with all parenteral solutions, compatibility of additive drugs with the solution must be evaluated before addition. Before adding a substance or drug, verify that it is soluble and/or stable in water and that the pH range of Electrolyte Rehydrating I is appropriate. After addition, check for any color change and/or formation of precipitates, insoluble complexes, or crystals.
Instructions for use of the additive drug and relevant literature should be consulted. Additive drugs known to be incompatible must not be used.
Baxter SpA Electrolyte Rehydrating I
When adding additive drugs to Electrolyte Rehydrating I, use aseptic technique. Mix the solution thoroughly when adding additive drugs; do not store solutions containing additive drugs.
Overdose
Symptoms
Excessive volume of the medicine may lead to fluid overload with risk of edema (peripheral and/or pulmonary), particularly when sodium excretion is impaired.
Excessive administration of Electrolyte Rehydrating may lead, depending on the patient's clinical condition, to hypernatremia and/or hypervolemia and hyperkalemia.
Hypernatremia and excessive sodium retention where renal sodium excretion is impaired lead to dehydration of internal organs, especially the brain, and accumulation of extracellular fluid with edema that may affect the cerebral, pulmonary, and peripheral circulation, resulting in pulmonary and peripheral edema.
High plasma potassium concentrations may cause death due to cardiac depression, arrhythmias, or arrest.
Excessive potassium administration may lead to the development of hyperkalemia, especially in patients with severe renal impairment.
Treatment
When assessing overdose, additive drugs in the solution must also be considered.
The effects of an overdose may require immediate medical attention and treatment.
Immediately discontinue the infusion and initiate corrective therapy to reduce plasma levels of excess ions and, if necessary, restore acid-base balance (see Precautions for Use).
The patient should be kept under observation to assess the onset of any signs and symptoms related to the administered drug, ensuring appropriate symptomatic and supportive measures as needed.
Loop diuretics may be used in cases of high natremia.
In cases of hyperkalemia, intravenous glucose (with or without insulin) or sodium bicarbonate may be administered.
Elevated plasma electrolyte levels may require dialysis.
In case of accidental ingestion/overdose of Electrolyte Rehydrating Baxter I, contact a doctor immediately or go to the nearest hospital.
If you have any doubts about the use of Electrolyte Rehydrating Baxter I, consult your doctor or pharmacist.
Undesirable Effects
Like all medicines, Electrolyte Rehydrating I can cause undesirable effects, although not everyone experiences them.
Baxter SpA Electrolyte Rehydrating I
The following undesirable effects of Electrolyte Rehydrating I are listed. There are insufficient data to establish the frequency of the individual effects listed.
Gastrointestinal disorders
Gastrointestinal disturbances, thirst, reduced salivation, nausea, vomiting, diarrhea, abdominal pain.
Nervous system disorders
Neuromuscular disturbances, paresthesia, flaccid paralysis, weakness, confusion, headache, dizziness, restlessness, fever, irritability, muscle rigidity, seizures, coma, death.
Cardiac disorders
Arrhythmias, conduction disorders, disappearance of the P wave, widening of the QRS complex on the electrocardiogram, cardiac arrest, tachycardia*, palpitations*.
Psychiatric disorders
Somnolence, confusion.
Respiratory, thoracic and mediastinal disorders
Dyspnea*, respiratory arrest, pulmonary edema, wheezing*.
Eye disorders
Reduced lacrimation.
Renal and urinary disorders
Renal failure.
Vascular disorders
Hypotension*, hypertension, peripheral edema, hyperemia*, flushing*.
Metabolism and nutrition disorders
Hypernatremia, hypervolemia, hyperchloremia, hyperosmolarity, hypocalcemia, metabolic acidosis, hyperkalemia.
General disorders and administration site conditions
Febrile episodes, infection/irritation at the infusion site, pain or local reaction, venous irritation, thrombosis or phlebitis extending from the infusion site, extravasation, tissue necrosis, burning sensation**, chest pain or discomfort*, chills*, feeling strange*.
Immune system disorders
Anaphylactoid reaction*, Urticaria*.
Baxter SpA Electrolyte Rehydrating I
Skin and subcutaneous tissue disorders
Piloerection*, cold sweats*.
Investigations
Increased respiratory rate*.
* Denotes manifestations of hypersensitivity/reactions at the infusion site
** May occur during product administration
Reporting of Undesirable Effects
If you experience any undesirable effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. You may also report undesirable effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting undesirable effects, you can help provide more information on the safety of this medicine.
Following the instructions in the package leaflet reduces the risk of undesirable effects.
Expiry and Storage
Expiry: see the expiry date on the packaging.
The expiry date refers to the product in intact packaging, correctly stored.
Caution: Do not use the medicine after the expiry date stated on the packaging.
Storage Conditions
Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
After opening the container, the contents must be used immediately and must not be stored for subsequent infusion. Do not reconnect partially used containers.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep the medicine out of the sight and reach of children.
Composition
1000 ml contains:
Active substances:
Sodium (S)-Lactate 60% solution 9.66 g
Sodium chloride 4.00 g
Potassium chloride 2.70 g
Excipients:
Water for injections q.s.
Hydrochloric acid q.s. to pH 5.5 – 7.0
mEq/liter: Na 120
K 36
Baxter SpA Electrolyte Rehydrating I
Cl 104
Lactate 52
Theoretical osmolarity (mOsm/liter) 312
pH 5.5–7.0
Pharmaceutical Form and Contents
Sterile infusion solution free from bacterial endotoxins.
Various pack sizes are available:
Glass bottles: 100, 250 and 500 ml Single packaging
Glass bottles 500 ml 20-unit packaging
Flexible bags ClearFlex: 100, 250, 500 and 1000 ml. Single packaging
Flexible bags ClearFlex: 500 ml 20-unit packaging
Flexible bags Viaflo: 1000 ml 10-unit packaging
Flexible bags Viaflo: 1000 ml 12-unit packaging
Marketing Authorization Holder
BAXTER S.p.A.
Piazzale dell’Industria 20 – 00144 Rome
Manufacturer
Bottles and bags:
BIEFFE MEDITAL S.p.A.
Via Nuova Provinciale - 23034 Grosotto (So)
Alternatively, bags may be manufactured by:
BIEFFE MEDITAL S.A.
Ctra de Biescas - 22666 Sabiñánigo (Spain)
PRESCRIPTION MEDICINE
...............................
Baxter SpA Electrolyte Rehydrating I
PACKAGE LEAFLET

ELECTROLYTE REHYDRATION BAXTER

III Infusion Solution
GENERIC MEDICINE
Pharmacotherapeutic Category
Electrolytes
Therapeutic Indications
Rehydration and replacement of fluids and electrolytes. Treatment of mild to moderate, but not severe, metabolic acidosis.
Contraindications

  • Known hypersensitivity to the active substances or to any of the excipients;
  • Hypercalcemia, hypercalciuria;
  • Severe renal insufficiency;

Baxter SpA Electrolyte Rehydration I

  • Hypernatremia;
  • Hydro-saline plethoras;
  • Hyperkalemia or conditions involving potassium retention;
  • Ventricular fibrillation (calcium chloride may increase the risk of arrhythmias);
  • Severe hepatic insufficiency (inability to metabolize the acetate ion);
  • Respiratory or metabolic alkalosis;
  • Renal calculi (may be exacerbated by calcium administration);
  • Sarcoidosis (may potentiate the typical hypercalcemia of this condition);
  • Hypercoagulability;
  • Concomitant therapy with cardiac glycosides (see Interactions);
  • Untreated Addison’s disease;
  • Acute dehydration;
  • Heat cramps.
  • Concomitant treatment with ceftriaxone in neonates (≤28 days of age), even when separate infusion lines are used. See Interactions, Undesirable Effects, and Incompatibilities.

Precautions for Use
Use in patients with hypervolemia or hyperhydration, or conditions causing sodium retention and edema
Due to the presence of sodium, use with caution in patients with congestive heart failure, severe renal insufficiency, and clinical conditions associated with edema and hydro-saline retention; in patients receiving inotropic cardiac drugs or corticosteroid or corticotropin medications.
The medicinal product must be administered with particular caution in hypervolemic or hyperhydrated patients.
The medicinal product must be administered with particular caution in patients with conditions that may cause sodium retention, fluid overload, and edema, such as primary hyperaldosteronism, secondary hyperaldosteronism (e.g., associated with hypertension, congestive heart failure, renal artery stenosis, or nephrosclerosis), peripheral or pulmonary edema, reduced renal function, pre-eclampsia, or other conditions associated with sodium retention (see Interactions).
Use in patients with or at risk of hyperkalemia
The medicinal product must be administered with particular care in patients with conditions predisposing to hyperkalemia (such as severe renal impairment or adrenocortical insufficiency, acute dehydration, or extensive tissue damage or burns) and in patients with cardiac disorders.
Due to the presence of potassium, administration should be guided by serial electrocardiograms; serum potassium levels do not reflect intracellular potassium concentrations.
High plasma potassium concentrations may cause death due to cardiac depression, arrhythmias, or arrest. To avoid potassium intoxication, the infusion must be slow.
The medicinal product must be administered with caution in patients:

  • With renal insufficiency (administration of potassium-containing solutions in patients with reduced renal function may cause potassium retention);
  • With heart failure, especially if digitalized;

Baxter SpA Electrolyte Rehydration I

  • With adrenal insufficiency;
  • With hepatic insufficiency;
  • With familial periodic paralysis;
  • With congenital myotonia;
  • In the early postoperative phase. Due to the presence of calcium, the medicinal product must be used with great caution in patients:
  • With renal disorders;
  • With cardiac disorders;
  • Who have received a blood transfusion, as calcium ion concentrations may differ from expected values. Since calcium chloride is acidifying, caution is required when administering it in conditions such as renal disorders, cor pulmonale, respiratory acidosis, or respiratory insufficiency, where acidification may worsen the clinical picture. Furthermore, caution is advised in conditions where there may be an increased risk of hypercalcemia, such as chronic renal insufficiency, dehydration, electrolyte imbalance, and calcium kidney stones or a history thereof. Since calcium salts may increase the risk of arrhythmias, care should be taken when prolonging calcium chloride administration in patients with cardiac disorders. Administration of calcium chloride may cause vasodilation and consequent lowering of blood pressure. Calcium chloride solution is irritating and therefore must not be administered intramuscularly, subcutaneously, or into peri-vascular tissue, as tissue necrosis may occur. Plasma calcium concentrations and urinary calcium excretion should be monitored frequently to avoid hypercalciuria, as hypercalciuria may lead to hypercalcemia. Use in patients with or at risk of hypermagnesemia Due to the presence of magnesium, the medicinal product must be administered with caution in patients:
  • With renal insufficiency;
  • With heart failure, especially if digitalized;
  • With severe myasthenia gravis;
  • Receiving central nervous system depressants or neuromuscular blocking agents;
  • With hypermagnesemia or conditions predisposing to hypermagnesemia, including but not limited to severe renal impairment or magnesium therapy such as for eclampsia. Serum magnesium levels must be closely monitored during therapy to ensure they do not exceed normal limits. Due to the presence of acetate, use with caution in patients with metabolic or respiratory alkalosis and in conditions where there is increased level or inadequate utilization of this ion, such as mild to moderate hepatic impairment. During infusion of the medicinal product, continuous monitoring of the electrocardiographic trace is essential, and it is good practice to monitor fluid balance, electrolytes, plasma osmolarity, blood pressure,

Baxter SpA Electrolyte Rehydration I
acid-base balance, and osteotendinous reflexes, the latter to monitor for possible respiratory paralysis.
Risk of gas embolism
Do not use plastic containers connected in series, as they may cause gas embolism due to possible residual air from the primary container.
Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates may cause gas embolism if residual air in the container is not completely eliminated before administration.
Using an intravenous administration set with the vent in the open position may cause gas embolism. Intravenous administration sets with the vent in the open position must not be used with flexible plastic containers.
Administration of anticoagulant citrates used to preserve blood
Due to the risk of coagulation precipitates caused by calcium content, the medicinal product must not be added to or administered through the same administration set as anticoagulant citrates used to preserve blood.
Use in pediatric patients
The safety and efficacy of the medicinal product in children have not been established by adequate and well-controlled studies.
Use in elderly patients
When selecting the type of infusion solution and the volume/rate of infusion for an elderly patient, consider that elderly patients generally have a higher likelihood of cardiac, renal, hepatic, or other diseases or are receiving concomitant therapy.
Interactions
Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription.
Caution is advised when administering the medicinal product to patients treated with drugs whose renal elimination depends on pH. Due to its alkalinizing effect (bicarbonate formation), the medicinal product may interfere with the elimination of such drugs:

  • Renal clearance of acidic drugs such as salicylates, barbiturates, and lithium may be increased;
  • Renal clearance of alkaline drugs such as sympathomimetics (e.g., ephedrine, pseudoephedrine), quinidine, or dextroamphetamine sulfate may be decreased. Due to potassium content, the medicinal product must be administered with caution in patients treated with agents or products that may cause hyperkalemia or increase its risk, such as potassium-sparing diuretics (amiloride, spironolactone, triamterene), especially in the presence of renal dysfunction. Therefore, in such cases, serum potassium levels must be closely monitored. Use of drugs such as ACE inhibitors, which cause decreased aldosterone levels, may lead to potassium retention. Therefore, serum potassium levels must be closely monitored. Due to potassium content and the risk of hyperkalemia, administer with caution also in patients treated with angiotensin II receptor antagonists or immunosuppressants such as

Baxter SpA Electrolyte Rehydration I
tacrolimus and
cyclosporine. Administration of potassium in patients treated with such drugs may cause severe and potentially fatal hyperkalemia, particularly in patients with severe renal insufficiency.
Caution is advised when administering the medicinal product to patients treated with drugs that may increase the risk of sodium and water retention, leading to edema and hypertension, such as corticosteroids, cardiac inotropic agents, or corticotropin drugs (see Precautions for Use).
Calcium chloride solution may interact with the following medicinal products:

  • Thiazide diuretics or vitamin D, as hypercalcemia may occur due to reduced renal calcium excretion;
  • Cardiac glycosides (digitalis), digoxin, and digitoxin, as concomitant use may increase the risk of arrhythmias due to synergistic inotropic and toxic effects;
  • Verapamil (and other calcium channel blockers), as concomitant use may reduce the antihypertensive effect of verapamil;
  • Medicinal products containing magnesium, as this may increase the risk of hypercalcemia or hypermagnesemia, especially in patients with renal disorders;
  • Neuromuscular blockers: calcium salts may antagonize the action of non-depolarizing blockers; in some cases, an increase and prolongation of the action of tubocurarine has also been observed.

As with other calcium-containing solutions, concomitant treatment with ceftriaxone is contraindicated
in neonates (≤28 days of age), even when separate infusion lines are used (risk of fatal precipitation of ceftriaxone-calcium salt in the neonate's bloodstream, see section Undesirable Effects).
In patients older than 28 days (including adults), ceftriaxone must not be administered concomitantly with intravenous solutions containing calcium, including Electrolyte Rehydration III, through the same infusion line (e.g., via a Y-connector).
If the same line is used for sequential administrations, it must be flushed with a compatible fluid between infusions.
Magnesium chloride may interact with the following medicinal products:

  • Central nervous system depressants: when barbiturates, narcotics, or other hypnotics (or systemic anesthetics) or other drugs that depress the central nervous system are administered concurrently with magnesium, their dosage must be carefully adjusted due to the additive central nervous system depressant effect of magnesium. Central nervous system and peripheral transmission depression caused by magnesium may be antagonized by calcium;
  • Cardiac glycosides (digitalis), digoxin, and digitoxin: magnesium chloride must be administered with extreme caution in patients taking digitalis due to changes in cardiac conduction that may lead to cardiac arrhythmia if calcium administration becomes necessary to treat magnesium intoxication;

Baxter SpA Electrolyte Rehydration I

  • Competitive and depolarizing neuromuscular blockers: parenteral administration of magnesium chloride potentiates the effect of competitive and depolarizing neuromuscular junction blockers;
  • Aminoglycoside antibiotics: the effect on neuromuscular blockade of parenterally administered magnesium and aminoglycoside antibiotics may be additive;
  • Eltrombopag: administration of products containing aluminum, calcium, or magnesium may reduce plasma concentrations of eltrombopag;
  • Rocuronium: simultaneous administration of rocuronium and magnesium may increase the risk of rocuronium toxicity (prolonged neuromuscular blockade, respiratory depression, and apnea);
  • Labetalol: simultaneous administration of labetalol and magnesium may cause bradycardia and decreased cardiac output (shortness of breath, dizziness, or fainting);
  • Calcium antagonists (isradipine, felodipine, nicardipine, and nifedipine): concomitant administration of magnesium with a calcium antagonist drug may result in hypotension.

Special Warnings
The medicinal product is not indicated for the treatment of hypochloremic hypokalemic alkalosis and must be used with caution in patients with hypochloremic hypokalemic alkalosis (e.g., due to prolonged vomiting, pyloric stenosis, prolonged nasogastric aspiration).
The medicinal product is not indicated for the treatment of hypomagnesemia.
The medicinal product is not indicated for the treatment of hypocalcemia.
Hypersensitivity reactions
Hypersensitivity reactions/infusion reactions, including anaphylactoid reactions, have been reported with other electrolyte-containing solutions.
Infusion must be stopped immediately if any sign or symptom of a suspected hypersensitivity reaction occurs. Appropriate therapeutic countermeasures must be instituted as clinically indicated.
Risk of fluid and/or solute overload and electrolyte imbalances
Depending on the volume and rate of infusion, intravenous administration of the medicinal product may cause:

  • fluid and/or solute overload leading to hyperhydration/hypervolemia and, for example, congestive states, including pulmonary congestion and edema
  • clinically relevant electrolyte imbalances and acid-base imbalance In general, the risk of dilution states is inversely proportional to the electrolyte concentrations of the medicinal product. The risk of solute overload that may cause congestive states is directly proportional to the electrolyte concentrations of the medicinal product. Clinical evaluation and periodic laboratory tests may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or in any case where the patient's condition or rate of administration requires such evaluation.

Baxter SpA Electrolyte Rehydration I
Use immediately after opening the container. The solution must be clear, colorless, and free of visible particles. It is for single, uninterrupted administration and any unused portion must not be retained.
Pregnancy and Lactation
No data are available on possible adverse effects of the medicinal product when administered during pregnancy or lactation or on reproductive capacity.
Therefore, the medicinal product must not be used during pregnancy and lactation unless absolutely necessary and only after evaluating the risk/benefit ratio.
Avoid use of magnesium 2 hours before delivery. If magnesium chloride is administered (especially for more than 24 hours before delivery) to control seizures in mothers with toxemic pregnancy, neonates may show signs of magnesium toxicity, including neuromuscular and respiratory depression.
Effects on Ability to Drive and Use Machines
The medicinal product does not affect the ability to drive or use machines.
Dosage, Route, and Duration of Administration
The solution is isotonic with blood and must be administered by intravenous infusion with caution and at a controlled infusion rate.
Shake well during preparation and before use.
The dose, rate, and duration of administration must be individualized and depend on the patient's age, weight, clinical condition, concomitant therapy, and clinical and laboratory response to treatment.
The medicinal product must be administered only with intact renal function and at a rate not exceeding 10 mEq potassium/hour.
Adults
Generally, the dose is 3 liters/day, administered at an infusion rate of approximately 1 liter/hour.
Children
In children, the safety and efficacy of the medicinal product have not been determined.
Do not inject intramuscularly, subcutaneously, or into perivascular tissues.
Administration must be stopped if the patient experiences pain or redness at the injection site, as this may indicate extravasation of the drug.
Too rapid infusions may cause local pain, and the infusion rate must be adjusted according to tolerance.
It is advisable for the patient to remain lying down for a short period after administration.
Use immediately after opening the container. The container is for single, uninterrupted administration and any unused portion must not be retained. Shake well before administration.
Do not use the medicinal product if the solution is not clear and colorless or contains particles.
Baxter SpA Electrolyte Rehydration I
Take all usual precautions to maintain sterility before and during intravenous infusion.
Parenteral medicinal products must be visually inspected for particulate matter and discoloration when the solution and container permit. Do not administer if the solution is not clear or if the seal is not intact.
When adding additive drugs to Electrolyte Rehydration III, use an aseptic technique. Mix the solution thoroughly after adding additive drugs; do not store solutions containing additive drugs (see Incompatibilities).
Incompatibilities with Electrolyte Rehydration Baxter III:
Due to the presence of calcium chloride, the medicinal product is incompatible with:

  • Magnesium sulfate: precipitation occurs;
  • Medicinal products containing phosphate: calcium phosphate precipitate forms;
  • Medicinal products containing carbonate: calcium carbonate precipitate forms;
  • Medicinal products containing tartrate: calcium tartrate precipitate forms. Incompatibilities of calcium chloride have been observed with:
  • Aminophylline: due to precipitate formation;
  • Amphotericin B: due to cloudiness;
  • Cefamandole: due to presence of sodium carbonate in cefamandole preparation;
  • Ceftriaxone sodium: calcium salts may form complexes with many drugs, leading to precipitate formation. Physical incompatibility has been reported with ceftriaxone (see sections Contraindications, Interactions, and Undesirable Effects). Calcium solution administration must not occur within 48 hours after ceftriaxone administration;
  • Cephalothin: due to physical incompatibility;
  • Cefradine: due to presence of sodium carbonate in cefradine preparation;
  • Chlorpheniramine: due to physical incompatibility;
  • Dobutamine: due to cloudiness;
  • Fat emulsion: due to flocculation;
  • Sodium heparin;
  • Indomethacin: due to precipitate formation;
  • Sodium nitrofurantoin;
  • Promethazine: due to precipitate formation;
  • Propofol: due to precipitate formation;
  • Streptomycin: calcium may inhibit streptomycin activity;
  • Tetracyclines: calcium salts may complex with tetracyclines. Due to magnesium content, the medicinal product is incompatible with solutions containing alcohol (at high concentrations), heavy metals, carbonates and bicarbonates, sodium hydrocortisone, succinates, phosphates, polymyxin B sulfate, procaine hydrochloride, calcium salicylate, clindamycin phosphate, tartrates, as precipitates may form.

Baxter SpA Electrolyte Rehydration I
Potential incompatibility is often influenced by changes in reagent concentrations and solution pH.
Additive drugs may be incompatible with the medicinal product. As with all parenteral solutions, compatibility of additive drugs with the solution must be evaluated before addition. Before adding a substance or drug, verify its solubility and/or stability in water and whether the pH range of Electrolyte Rehydration III is appropriate. After addition, check for any color change and/or formation of precipitates, insoluble complexes, or crystals.
Consult the Instructions for Use of the additive drug and relevant literature. Additive drugs known to be incompatible must not be used.
Mix the solution thoroughly when adding additive drugs; do not store solutions containing additive drugs.
Overdose
Symptoms
Excessive volume of the medicinal product may lead to fluid and sodium overload with risk of edema (peripheral and/or pulmonary), particularly when sodium excretion is impaired.
Excessive administration of sodium chloride may lead, depending on the patient's clinical condition, to hypernatremia and/or hypervolemia. Hypernatremia and excessive sodium retention where renal sodium excretion is impaired lead to dehydration of internal organs, especially the brain, and accumulation of extracellular fluids with edema affecting the cerebral, pulmonary, and peripheral circulation, resulting in pulmonary and peripheral edema.
High plasma potassium concentrations may cause death due to cardiac depression, arrhythmias, or arrest.
Excessive administration of potassium may lead to hyperkalemia, especially in patients with severe renal insufficiency.
Excessive administration of magnesium may lead to hypermagnesemia. With high doses of magnesium chloride, the following signs of intoxication may occur: flushing, sweating, hypotension, flaccid paralysis, hypothermia, circulatory collapse, cardiac and central nervous system depression that may progress to respiratory paralysis.
Magnesium intoxication manifests with a peak in blood pressure and respiratory paralysis.
Disappearance of the patellar reflex is a useful clinical sign to identify the onset of intoxication.
With high doses of calcium chloride, hypercalcemia may occur, especially in patients with renal disorders. Typical symptoms of hypercalcemia are: thirst, nausea, vomiting, constipation, polyuria, abdominal pain, muscle weakness, mental disturbances, and in severe cases, cardiac arrhythmias and coma. Hypercalcemia is defined as plasma calcium concentrations exceeding 2.6 mmol/l; therefore, such concentrations must be constantly monitored.
Treatment
When evaluating an overdose, any drugs added to the solution must also be considered.
Baxter SpA Electrolyte Rehydration I
The effects of an overdose may require immediate medical attention and treatment.
Immediately discontinue the infusion and initiate corrective therapy to reduce plasma levels of excess ions and, if necessary, restore acid-base balance (see Precautions for Use).
The patient should be closely observed for the appearance of any signs and symptoms related to the administered drug, ensuring appropriate symptomatic and supportive measures as needed.
In cases of high natremia, loop diuretics may be used.
In cases of hyperkalemia, intravenous glucose (with or without insulin) or sodium bicarbonate may be administered.
For mild calcium chloride overdose, treatment includes immediate discontinuation of the infusion and any other calcium-containing drug. In cases of severe overdose (plasma concentrations >2.9 mmol/l), the following measures should be taken:

  • Rehydration by administration of 0.9% sodium chloride solution;
  • Use of non-thiazide diuretics to promote calcium excretion;
  • Monitor plasma potassium and magnesium levels and immediately restore them to normal values;
  • Monitor cardiac function and use beta-blockers to reduce the risk of cardiac arrhythmia;
  • Consider hemodialysis if necessary. In cases of magnesium overdose, artificial respiration is required. To counteract the effects of hypermagnesemia, intravenous calcium must be administered (10-20 ml of a 5% solution). Subcutaneous administration of 0.5-1 mg of physostigmine may be helpful. Elevated plasma electrolyte levels may require dialysis.

In case of accidental ingestion/overdose of Electrolyte Rehydration Baxter III, contact a doctor immediately or go to the nearest hospital.
If you have any doubts about the use of Electrolyte Rehydration Baxter III, consult your doctor or pharmacist.
Undesirable Effects
Like all medicines, Electrolyte Rehydration III may cause undesirable effects, although not everyone will experience them.
The following are undesirable effects of Electrolyte Rehydration III. There are insufficient data to establish the frequency of the individual effects listed.
Gastrointestinal Disorders
Gastrointestinal disturbances and irritation, thirst, reduced salivation, nausea, vomiting, diarrhea, abdominal pain, constipation, delayed intestinal transit, paralytic ileus, metallic taste, chalky taste.
Baxter SpA Electrolyte Rehydration I
Nervous System Disorders
Neuromuscular disorders, muscle stiffness, paresthesia, flaccid paralysis, weakness, confusion, headache, dizziness, restlessness, irritability, seizures, coma, death.
Psychiatric Disorders
Somnolence, confusion, mental disturbances.
Cardiac Disorders
Arrhythmias, tachycardia*, bradycardia, conduction disorders, disappearance of P wave, widening of QRS on electrocardiogram, syncope, ventricular fibrillation, cardiac arrest, palpitations*.
Vascular Disorders
Hypotension*, hypertension, peripheral edema, vasodilation, flushing, excessive sweating, shock, hyperemia*, flushing*.
Respiratory, Thoracic and Mediastinal Disorders
Dyspnea*, respiratory arrest, pulmonary edema, pneumothorax, wheezing*.
Eye Disorders
Reduced lacrimation.
Renal and Urinary Disorders
Renal failure, polyuria.
Metabolism and Nutrition Disorders
Hypercalcemia, Burnett’s syndrome (milk-alkali syndrome), hypocalcemia, hypernatremia, hypervolemia, hyperchloremia, hyperkalemia.
Musculoskeletal and Connective Tissue Disorders
Muscle weakness.
General Disorders and Administration Site Conditions
Fever, infection/irritation at infusion site, pain or local reaction, redness, rash, venous irritation, thrombosis or phlebitis extending from the infusion site, extravasation, tissue necrosis, abscess formation, cutaneous calcification, erythema, burning sensation**, chest pain or discomfort*, chills*, feeling strange*.
Immune System Disorders
Anaphylactoid reaction*, urticaria*.
Baxter SpA Electrolyte Rehydration I
Skin and Subcutaneous Tissue Disorders
Piloerection*, cold sweats*.
Investigations
Increased respiratory rate*.
* Denotes manifestations of hypersensitivity/reactions at infusion site
** May occur during product administration.
Precipitation of calcium-ceftriaxone salt
Serious, and in some cases fatal, adverse reactions have rarely been reported in preterm and full-term neonates (age < 28 days) treated with intravenous ceftriaxone and calcium. Post-mortem findings revealed calcium-ceftriaxone salt precipitation in the lungs and kidneys. The high risk of precipitation in neonates is due to their low blood volume and longer ceftriaxone half-life compared to adults (see sections Contraindications and Interactions).
Cases of renal precipitation have been reported, mainly in children over 3 years of age treated with high daily doses (e.g., ≥ 80 mg/kg/day) or total doses exceeding 10 grams and who had other risk factors (e.g., fluid restriction, bedridden patients). The risk of precipitate formation increases in immobilized or dehydrated patients. This event may be symptomatic or asymptomatic, may cause renal failure and anuria, and is reversible upon discontinuation of administration.
Calcium-ceftriaxone salt precipitation in the gallbladder has been observed, mainly in patients treated with doses above the recommended standard dose. In children, prospective studies have shown variable incidence of precipitation with intravenous administration; in some studies, the incidence exceeded 30%. This incidence appears lower when infusions are administered slowly (20-30 minutes). This effect is generally asymptomatic, but in rare cases, precipitations have been accompanied by clinical symptoms such as pain, nausea, and vomiting. In such cases, symptomatic treatment is recommended. Precipitation is generally reversible upon discontinuation of administration.
Reporting of Undesirable Effects
If you experience any undesirable effect, including those not listed in this leaflet, consult your doctor or pharmacist. Undesirable effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
Reporting of undesirable effects helps provide more information on the safety of this medicinal product.
Expiry and Storage
Expiry: see the expiry date on the packaging.
The expiry date refers to the product in intact packaging, correctly stored.
Baxter SpA Electrolyte Rehydration I
Caution: Do not use after this date
Storage Conditions
Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
After opening the container, the contents must be used immediately and must not be stored for subsequent infusion. Do not reconnect partially used containers.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Keep this medicine out of the sight and reach of children.
Composition
1000 ml contains:
Active substances: Sodium chloride 5.0 g
Potassium chloride 0.75 g
Calcium chloride dihydrate 0.35 g
Magnesium chloride hexahydrate 0.31 g
Sodium acetate trihydrate 6.40 g
Sodium citrate 0.75 g
mEq/liter: Na 140
K 10
Ca 5
Mg 3
Cl 103
Acetate 47
Citrate 8
Theoretical osmolarity: (mOsm/liter) 307
pH: 5.0–7.0
Excipients:
Water for injections q.s. to 1000 ml
Hydrochloric acid q.s. to pH 5.0–7.0
Pharmaceutical Form and Contents
Sterile, endotoxin-free infusion solution
Various pack sizes available:
Glass bottles: 100, 250, and 500 ml Single packaging
Glass bottles: 500 ml Pack of 20 units
Flexible bags: 100, 250, 500, and 1000 ml. Single packaging
Flexible bags: 500 ml Pack of 20 units
Marketing Authorization Holder
BAXTER S.p.A.
Piazzale dell’Industria 20 – 00144 Rome
Baxter SpA Electrolyte Rehydration I
Manufacturer:
Bottles and bags:
BIEFFE MEDITAL S.p.A.
Via Nuova Provinciale - 23034 Grosotto (SO)
Alternatively, bags may be produced by:
BIEFFE MEDITAL S.A.
Ctra de Biescas - 22666 Sabiñánigo (Spain)
MEDICINAL PRODUCT SUBJECT TO MEDICAL PRESCRIPTION