Isolyte

Patient Information Leaflet

ISOLYTE infusion solution

Electrolytes associated with carbohydrates
Please read this leaflet carefully before you are given this medicine
because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or nurse. See section 4.

Contents of this leaflet:

1. What ISOLYTE is and what it is used for
2. What you need to know before you are given ISOLYTE
3. How ISOLYTE is administered
4. Possible side effects
5. How ISOLYTE is stored
6. Contents of the pack and other information

1. What Isolyte is and what it is used for

Isolyte is an infusion solution containing electrolytes combined with carbohydrates.
Isolyte is indicated for the treatment of extracellular fluid and electrolyte losses, when it is necessary to:

• correct mild or moderate, but not severe, metabolic acidosis, a condition characterized by increased blood acidity,
• provide a caloric intake to the body.

Consult your doctor if you do not feel better or if you feel worse.

2. What you should know before you are given ISOLYTE

You will not be given ISOLYTE

• If you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
• If you have an abnormally high level of sugar in your blood (hyperglycemia).
• If you have high levels of potassium in your blood (hyperkalemia) or have a reduced ability to eliminate potassium from your body (potassium retention).
• If you have high levels of calcium in your blood (hypercalcemia).
• If you suffer from severe liver disease (severe hepatic insufficiency).
• If you have high levels of acetate or impaired ability to metabolize acetate.
• If you have low levels of acid in your blood (metabolic and respiratory alkalosis).
• If you are receiving a blood transfusion.
• If you have a congenital heart defect.
• If you suffer from severe kidney disease (severe renal failure).
• If you have fluid accumulation causing swelling (edema due to sodium retention).
• If you have any condition leading to high levels of potassium in your blood (hyperkalemia), such as:
  • Renal impairment
  • Adrenal or adrenocortical insufficiency (a disease of the adrenal glands affecting hormones that regulate substance concentrations in the body)
  • Acute dehydration (loss of water from the body, e.g., due to vomiting or diarrhea)
  • Extensive tissue damage (which may occur in severe burns)
  • Heart diseases

ISOLYTE is not indicated for the treatment of hypophosphatemia.
If the patient is a neonate (≤ 28 days of age), ISOLYTE must not be administered concomitantly with ceftriaxone (an antibiotic), even if separate infusion lines are used (see Other medicines and ISOLYTE).
In children and adults, ceftriaxone must not be administered simultaneously with intravenous solutions containing calcium, including ISOLYTE, through the same infusion line (e.g., via Y-connectors). If the same infusion line is used for sequential administration, the line must be thoroughly flushed between infusions with a compatible fluid.
Do not connect flexible plastic containers in series, as this may result in air embolism (formation of air bubbles in blood vessels) due to possible residual air in the primary container (see Precautions for use. Air embolism).

Warnings and precautions

Talk to your doctor or nurse before you are given ISOLYTE:

• If you have kidney problems (severe renal failure, reduced kidney function), as administration of this solution may cause sodium or potassium retention.
• If you have heart problems (congestive heart failure).
• If you suffer from fluid accumulation and swelling (see: "You will not be given ISOLYTE").
• If you suffer from sodium retention (see: "You will not be given ISOLYTE").
• If you have diabetes mellitus or glucose intolerance; your doctor will monitor your blood sugar levels and adjust therapy as necessary.
• If you are taking medications for the heart (cardiotonic inotropic agents) or corticosteroid or corticotropin medications—extreme caution is required (see section Other medicines and ISOLYTE).
• If you suffer from low levels of chloride and potassium ions in the blood with increased alkalinity in the body (hypochloremia, hypokalemia, alkalosis).
• If you are allergic to maize or maize-derived products.
• If you have high levels of magnesium in your blood (hypermagnesemia) or conditions predisposing to it, such as severe kidney disease (severe renal insufficiency), or if you are receiving magnesium therapy (e.g., for eclampsia—a condition that may affect pregnant women) or taking medications that may increase magnesium levels in the blood (e.g., lithium, antacids, laxatives).
• If you suffer from muscle weakness (myasthenia gravis).
• If you suffer from increased alkalinity in the blood (alkalosis).
• If you have increased blood volume (hypervolemia) or are overhydrated.
• If you have kidney stones or a history of kidney stones.
• If you are in a condition that may cause high levels of vasopressin, a hormone that regulates fluids in your body. You may have excessive vasopressin in your body, for example, if:
  • You have had a sudden, serious illness
  • You have pain
  • You have undergone surgery
  • You have an infection, burns, or a brain disorder
  • You have diseases affecting the heart, liver, kidneys, or central nervous system
  • You are taking certain medications (see section Other medicines and ISOLYTE)
    This may increase the risk of low sodium levels in the blood, which can cause headache, nausea, vomiting, seizures, lethargy, coma, cerebral edema, and death. Cerebral edema increases the risk of death and brain damage. Individuals at high risk of cerebral edema include:
  • Children
  • Women (especially women of childbearing age)
  • Individuals with conditions affecting cerebrospinal fluid levels, such as meningitis, intracranial hemorrhage, or brain injury

Inform your doctor or nurse immediately if you notice or suspect a hypersensitivity reaction such as swelling, palpitations, shortness of breath, or skin rash. Infusion must be stopped immediately at the first sign of a hypersensitivity reaction so that appropriate therapeutic countermeasures can be taken (see Precautions for use).

Children

The safety and efficacy of ISOLYTE in children have not been established.

Other medicines and ISOLYTE

Inform your doctor if you are taking, have recently taken, or might take any of the following medicines:

• Corticosteroids (medicines used to treat inflammation and allergies),
• Corticotropin,
• Ceftriaxone (an antibiotic). Ceftriaxone must not be administered simultaneously or concurrently with intravenous solutions containing calcium, including ISOLYTE, through the same infusion line (e.g., via Y-connectors), in both pediatric and adult populations. If the same infusion line is used for sequential administration, the line must be thoroughly flushed between infusions with a compatible fluid. Concomitant treatment with ceftriaxone is contraindicated in neonates (≤28 days of age), even when separate infusion lines are used (risk of precipitation of particles in the neonate’s bloodstream, which may be fatal).
• Salicylates: medicines used to treat inflammation and fever.
• Barbiturates: medicines used to treat seizures or sleep disorders.
• Lithium: a medicine used to treat certain psychiatric conditions (bipolar disorders).
• Ephedrine: a medicine used to treat low blood pressure or bronchospasms in asthma or bronchitis.
• Pseudoephedrine: a medicine used to treat cold and flu symptoms.
• Quinidine: a medicine used to treat or prevent irregular heartbeats.
• Dextroamphetamine (or dexamfetamine) sulfate: a medicine used to treat attention deficit disorders.

Some medicines affect the vasopressin hormone. These may include:

• Antidiabetic drugs (chlorpropamide)
• Cholesterol-lowering drugs (clofibrate)
• Some anticancer drugs (vincristine, ifosfamide, cyclophosphamide)
• Selective serotonin reuptake inhibitors (used to treat depression)
• Antipsychotics or opioids for severe pain relief
• Analgesic and/or anti-inflammatory drugs (also known as NSAIDs)
• Drugs that mimic or enhance the effect of vasopressin, such as desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat esophageal bleeding), and oxytocin (used to induce labor)
• Antiepileptic drugs (carbamazepine and oxcarbazepine)
• Diuretics (drugs to increase urine output)

The following interactions should be considered in case of increased blood levels of:

Sodium

• Corticosteroids and carbenoxolone, as they may promote sodium and water retention (leading to edema and high blood pressure).

Potassium
These medicines may increase potassium levels in the blood, especially if you have kidney disease:

• Suxamethonium, a medicine used for muscle relaxation;
• Potassium-sparing diuretics (amiloride, spironolactone, triamterene, alone or in combination);
• Tacrolimus, cyclosporine, medicines used after organ transplantation to prevent rejection;
• ACE inhibitors, medicines used to treat high blood pressure;
• Heparin, a medicine used to prevent blood clot formation.

Calcium

• Digitalis glycosides, medicines used to treat heart rhythm disorders, especially if you have high calcium levels in the blood (hypercalcemia).
• Vitamin D, a medicine used to support bone development.

Pregnancy, breastfeeding, and fertility

ISOLYTE should be administered with particular caution to pregnant women during labor, especially if given concomitantly with oxytocin, due to the risk of hyponatremia (see sections "Warnings and precautions" and "Other medicines and ISOLYTE").

If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before receiving this medicine.

The safety of this product in pregnant women has not been established.

ISOLYTE will be administered during pregnancy and breastfeeding only if clearly needed.

Maternal intravenous infusion of glucose-containing solutions during labor may stimulate fetal insulin production, increasing the risk of fetal hyperglycemia and metabolic acidosis, as well as rebound hypoglycemia in the newborn.

3. How ISOLYTE is administered

ISOLYTE will be prepared by a doctor, pharmacist, or nurse and will not be mixed or administered simultaneously with injections containing ceftriaxone.
ISOLYTE is generally administered by a doctor or nurse through intravenous infusion (into a vein).
Before and during the infusion, your doctor will monitor:

• potassium levels
• fluid volume in your body
• blood and urine acidity
• electrolyte levels in your body (particularly sodium, in patients with high vasopressin levels or who are taking other medicines that enhance the effect of vasopressin).

If you have any doubts, consult your doctor.
Your doctor will determine the appropriate dose of ISOLYTE for you, based on your age, weight, and health condition.

Use of ISOLYTE in the elderly.
In elderly patients, selection of the type of infusion solution and the volume/infusion rate should take into account the increased risk of concomitant cardiac, renal, hepatic, and/or other diseases and/or concomitant medications.

If you are given more ISOLYTE than you should be
It is highly unlikely that you will receive more infusion solution than required, as your doctor or nurse will monitor you during treatment.
Should you accidentally be given more Isolyte than prescribed, the doctor will stop the infusion and monitor you closely.

If you have any questions about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Cases of renal precipitation of calcium-ceftriaxone have been reported, mainly in children over 3 years of age treated with high daily doses. The risk of precipitate formation increases in bedridden or dehydrated patients. You may experience pain when urinating, or the amount of urine produced may decrease.
Precipitation of calcium-ceftriaxone salt in the gallbladder has been observed, mainly in patients treated with doses higher than the recommended standard dose, which may be accompanied by pain, nausea, and vomiting.
The possible side effects are listed below according to the following frequency:
Not known (frequency cannot be estimated from the available data)

• severe allergic reactions which may cause difficulty in breathing or dizziness (anaphylactoid reactions), hives
• high blood glucose levels (hyperglycaemia)
• high blood potassium levels (hyperkalaemia)
• fast heartbeat (tachycardia) or rapid and irregular heartbeat (palpitations)
• low blood pressure (hypotension), eye redness (hyperaemia)
• shortness of breath (dyspnoea), gasping
• goosebumps (piloerection), cold sweats
• reactions due to the method of administration: infection at the injection site, inflammation and/or blockage of the vein at the injection site (phlebitis, thrombophlebitis, venous thrombosis), localized pain at the injection site, fever, chills, redness, burning sensation, chest pain, malaise, weakness, feeling unwell, flushing, fluid accumulation under the skin, particularly in the ankles (peripheral oedema)
• increased respiratory rate
• Hospital-acquired hyponatraemia (low sodium levels in the blood which may develop during hospitalization)*
• Hyponatraemic encephalopathy (brain disorders)*

*Acute hyponatraemia may cause irreversible brain damage and death due to the development of cerebral oedema/swelling (see also section “Warnings and Precautions”)
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system at website: www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How ISOLYTE is stored

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bag after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ISOLYTE contains

• The active substances in 1000 ml of solution are:

mEq/liter approximately
Sodium 50.0
Potassium 22.5
Magnesium 5.0
Calcium 2.5
Chloride 50.0
Acetate 38.0
mOsm/l 450 approximately
pH 5 approximately
Kcal/l 200 (837 kJ/l)

• Other components are water for injections, acetic acid.

Description of the appearance of ISOLYTE and contents of the pack
ISOLYTE is a solution contained in a plastic Clearflex bag, sealed and enclosed in a plastic pouch.
ISOLYTE is a sterile, clear solution.
The bag contains 2000 ml of solution.
It is available in packs of 6 bags per box.
Marketing Authorization Holder and Manufacturer
Baxter S.p.A. - Via del Serafico 89
00142 Rome
Manufacturer
Bieffe Medital S.p.A. - Via Nuova Provinciale - 23034 Grosotto (SO)

The following information is intended exclusively for physicians or healthcare professionals:
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 List of Excipients.
As with other infusion solutions containing calcium, concomitant administration of ceftriaxone and ISOLYTE is contraindicated in neonates (≤28 days of age), even if separate infusion lines are used (there is a risk of formation of fatal precipitates of calcium and ceftriaxone salts in the circulatory system of infants). See sections 4.8 and 6.2.
In the pediatric population (patients older than 28 days) and in adults, ceftriaxone must not be administered simultaneously with intravenous solutions containing calcium, including ISOLYTE, through the same infusion line (e.g., via Y-connectors). If the same infusion line is used for sequential administration, the line must be thoroughly flushed between infusions with a compatible fluid.
ISOLYTE is contraindicated in patients with:

• clinically significant hyperglycemia
• hyperkalemia or conditions associated with potassium retention
• hypercalcemia
• severe hepatic insufficiency
• congenital cardiac defects
• severe renal insufficiency or clinical conditions associated with edema and sodium retention
• elevated acetate levels or impaired acetate metabolism, or in the presence of metabolic or respiratory alkalosis.

Due to the risk of coagulation, Isolyte (an aqueous solution, i.e., a glucose solution without electrolytes) must not be administered during blood transfusion, nor through the same venous line simultaneously using the same blood transfusion set, due to the possibility of pseudoagglutination or hemolysis.
Due to the risk of clot precipitation caused by its calcium content, ISOLYTE must not be administered simultaneously through the same lines with citrate-based anticoagulants or blood preservatives.
Do not connect flexible plastic containers in series to avoid gas embolism due to possible residual air in the primary container. (See section 4.4 Gas Embolism)
Precautions for use
Intravenous administration of this solution may lead to fluid or electrolyte overload and result in dilution of serum electrolyte concentrations, hyperhydration, congestive states, or pulmonary edema.
Dosage, rate, and duration of administration must be individualized and depend on the indication, age, weight, clinical condition, concomitant therapy, and the patient's clinical and laboratory response to treatment.
The infusion rate and volume of intravenous solutions containing dextrose must be selected cautiously in children (refer to the Pediatric population section).
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration. Do not administer unless the solution is clear and the seal is intact.
WARNINGS
Hypersensitivity and infusion-related reactions, including anaphylactoid reactions, have been reported with ISOLYTE.
Infusion must be stopped immediately at the first sign or symptom suggesting hypersensitivity reaction. Appropriate therapeutic countermeasures must be initiated.
Depending on the volume and rate of intravenous infusion, administration of ISOLYTE may cause:

• fluid or electrolyte overload leading to dilution of serum electrolyte concentrations, hyperhydration, congestive states, or pulmonary edema.
• clinically significant electrolyte disturbances and acid-base imbalance.

Clinical condition and laboratory tests (fluid balance, electrolyte levels) of the patient must be monitored to assess changes in fluid balance, electrolyte concentrations, acid-base balance, and plasma osmolarity during parenteral therapy with ISOLYTE, especially when prolonged, in order to evaluate patient status, dosage, or rate of administration.
Administer only with intact renal function and at an infusion rate not exceeding 10 mEq potassium/hour.
Administration of hyperosmolar solutions may cause venous irritation, including phlebitis.
Intravenous glucose infusions are generally isotonic solutions. However, in the body, glucose-containing solutions may become extremely hypotonic physiologically due to rapid glucose metabolism.
Monitoring of serum sodium is particularly important for hypotonic fluids and solutions.
ISOLYTE must be used with particular caution in patients with:

• hypochloremia, hypokalemia.
• known allergy to corn or corn-derived products
• severe renal impairment
• hyperosmolar conditions
• granulomatous diseases associated with increased calcitriol synthesis such as sarcoidosis
• calcium kidney stones or history of calcium kidney stones
• conditions predisposing to hypercalcemia, such as in patients with severe renal impairment and granulomatous diseases associated with increased calcitri0l synthesis such as sarcoidosis.
• congestive heart failure, in patients treated with cardiac inotropic drugs, corticosteroids, or corticotropin.
• impaired glucose tolerance or diabetes mellitus; monitor blood glucose levels to allow for necessary pharmacological adjustments
• hypermagnesemia or conditions predisposing to hypermagnesemia, including but not limited to severe renal impairment or magnesium therapy as in eclampsia, where clinical signs of magnesium excess should be monitored
• hypermagnesemia secondary to increased intake of antacids, laxatives, volume depletion, or lithium therapy, which impairs renal handling of magnesium (see section 4.5), myasthenia gravis

ISOLYTE must be administered with particular caution in patients with alkalosis or at risk of alkalosis, and excessive administration of ISOLYTE may cause metabolic alkalosis.
ISOLYTE must be administered with particular caution in patients with hypervolemia or fluid-overloaded patients.
ISOLYTE must be administered with particular caution in patients with conditions that may cause sodium retention, fluid excess, and edema, such as in patients with primary hyperaldosteronism, secondary hyperaldosteronism (associated, for example, with hypertension, congestive heart failure, renal artery stenosis, or nephrosclerosis), or preeclampsia.
Due to the presence of potassium, administration should be guided by serial electrocardiograms. It is important to note that hyperkalemia does not necessarily reflect intracellular potassium concentrations.
ISOLYTE must be administered with particular caution in patients with conditions predisposing to hyperkalemia such as adrenocortical insufficiency, acute dehydration, extensive tissue damage or burns, and in patients with cardiac diseases.
Gas embolism
Observance of the following precautions is important to avoid possible gas embolism:

• Do not connect flexible plastic containers in series to avoid gas embolism due to possible residual air in the primary container. Gas embolism risk exists when infusion bags are connected in series.
• Completely eliminate air from flexible plastic containers before administration. Applying high pressure to intravenous solutions contained in flexible plastic containers to increase flow rate may cause gas embolism if residual air has not been completely removed before administration. Gas embolism may occur when residual air in the primary container is drawn into the infusion set.
• Ventilated intravenous administration sets with the vent in the open position must not be used with flexible plastic containers, as this may cause gas embolism. Gas embolism may occur when residual air in the primary container is drawn into the infusion set. The risk of gas embolism also exists when intravenous solutions in flexible plastic containers containing residual air are pressurized.

Hyperglycemia
To avoid hyperglycemia, the infusion rate must not exceed the patient's ability to utilize glucose.
Hyperglycemia is implicated in increased cerebral ischemia and mental damage and reduced recovery capacity after acute ischemic stroke. Caution is recommended when using glucose-containing solutions in such patients.
Early hyperglycemia has been associated with poor outcomes in patients with severe traumatic brain injuries. Glucose-containing solutions should also be used cautiously in patients with head injuries, particularly during the first 24 hours after trauma.
If hyperglycemia occurs, the glucose administration rate should be reduced, or insulin administered or insulin dosage adjusted.
Use extreme caution in patients with impaired glucose tolerance or diabetes mellitus and monitor blood glucose levels to allow for necessary pharmacological adjustments.
Intrapartum maternal intravenous infusion of glucose-containing solutions may cause fetal insulin production, with an associated risk of fetal hyperglycemia and metabolic acidosis, as well as rebound hypoglycemia in the newborn.
Hyponatremia
Monitoring of serum sodium is particularly important for hypotonic solutions and fluids.
ISOLYTE may become extremely hypotonic after administration due to glucose metabolism in the body.
Electrolyte balance, serum glucose, serum sodium, and other electrolytes must be monitored before and during administration, especially in patients with non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant therapy with vasopressin agonists, due to the risk of hyponatremia.
Patients with non-osmotic vasopressin release (e.g., in the acute phase of illness, pain, postoperative stress, infections, burns, and central nervous system disorders), patients with cardiac, hepatic, or renal diseases, and patients treated with vasopressin agonists (see section 4.5) are particularly at risk of acute hyponatremia following infusion of hypotonic solutions.
Acute hyponatremia may cause acute hyponatremic encephalopathy (cerebral edema) characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema are particularly at risk of severe, irreversible, and life-threatening brain injury.
Children, women of childbearing age, and patients with reduced cerebral compliance (e.g., meningitis, intracranial hemorrhage, and cerebral contusion) are particularly at risk of severe, life-threatening cerebral edema caused by acute hyponatremia.
Depending on the tonicity of the solution, volume and rate of infusion, and the patient's underlying clinical condition and ability to metabolize glucose, intravenous glucose administration may cause electrolyte disturbances, particularly hypo- or hyperosmolar hyponatremia.
High-volume infusion should be used under specific monitoring in patients with cardiac or pulmonary insufficiency and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatremia.
Pediatric population
In children, safety and efficacy have not been established by adequate and well-controlled studies.
Infusion rate and volume depend on age, weight, metabolic and clinical condition of the patient, and concomitant therapies, and must be determined by medical professionals experienced in pediatric intravenous fluid therapy.
Neonates—especially premature infants with low birth weight—are at increased risk of developing hypo- or hyperglycemia and therefore require continuous monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control and prevent long-term adverse events. Hypoglycemia in neonates may cause prolonged epilepsy, coma, and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, primary or late bacterial and fungal infections, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged hospitalization, and death.
In children, it is important to define a precise dosage to avoid exceeding the patient's capacity to metabolize glucose.
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 with non-osmotic ADH secretion may cause hyponatremia.
In pediatric patients, and particularly in preterm neonates, the risk of developing hyponatremia is higher. Hyponatremia may cause headache, nausea, seizures, lethargy, coma, cerebral edema, and death. Therefore, acute symptomatic hyponatremic encephalopathy is considered a medical emergency.
Elderly patients When selecting a type of infusion solution and infusion volume/rate for elderly patients, it should be considered that these patients are generally more likely to have cardiac, renal, hepatic diseases, or other comorbidities and concomitant pharmacological therapies.
Method and time of administration
Use immediately after opening the container, after verifying its integrity.
For single, uninterrupted use only. Any unused portion must not be reused and must be discarded.
Use an aseptic technique.

1. Remove the bag from its protective pouch only at the time of use.
2. Check for leaks by pressing the bag. Inspect the solution for clarity and absence of foreign particles.
3. Hang the bag. Remove the protective cover from the bag's outlet tube.
4. Connect the intravenous administration set to be used, following the instructions for use provided.

To read the volume during administration, gently pull the bag slightly above the solution level.

• Precautions during administration
  • Do not use air vents.
  • Do not connect in series, as gas embolism may occur due to residual air drawn from the first container before solution administration from the second container.
• Do not store partially used bags.
  • Technique for adding supplementary medications If it is considered necessary to add supplementary medications, use an aseptic technique. Ensure complete mixing of added substances and their compatibility (see Other medicines and ISOLYTE).
• Keep the container in an upright position with tubing facing upwards.
• Disinfect the injection site.
• Inject the medication into the injection site using a 0.7–0.9 mm needle.
• Empty the tubes by pressing and gently agitate the container to ensure thorough mixing using the double inversion method. Unused medicine and waste materials derived from this medicine must be disposed of in accordance with local regulations.

Overdose
Symptoms
Administration of excessive doses of ISOLYTE may cause metabolic alkalosis. Metabolic alkalosis may also be accompanied by hypokalemia and reduced serum calcium and magnesium ion levels.
Excessive volume of ISOLYTE may cause fluid and sodium retention and risk of edema (peripheral and/or pulmonary), especially when renal sodium excretion capacity is impaired.
Excessive potassium administration may cause hyperkalemia, particularly in patients with severe renal insufficiency.
Excessive calcium administration may cause hypercalcemia.
Excessive magnesium administration may cause hypermagnesemia.
Excessive administration of glucose-containing solutions may cause hyperglycemia, hyperosmolarity, osmotic diuresis, and dehydration.
If overdose is due to added medications, signs and symptoms will depend on the added drugs.
Treatment In case of accidental overdose, treatment must be discontinued and the patient kept under observation to identify signs and symptoms related to the administered drug. If necessary, appropriate symptomatic and supportive measures should be taken.
When assessing an overdose, any additives added to the solution must also be considered. The effects of an overdose may require immediate treatment and clinical attention.