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  • Sodium Chloride 0.45 % and Glucose 5.0 % Solution for Infusion Baxter
    / Teva


    Active Ingredient *

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Solution for Infusion

    10 X 1000 ml

    full basket chart

    Solution for Infusion

    20 X 500 ml

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    Dosage

    As directed by a physician. Dosage is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations.
    The dosage and constant infusion rate of solution must be selected with caution in pediatric patients, particularly neonates and low weight infants, because of the increased risk of hyperglycemia/hypoglycemia.
    See prescribing information for full details.


    Indications

    Indicated to provide electrolytes and calories and as a source of water for hydration.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients
    Extracellular hyperhydration or hypervolaemia
    Fluid and sodium retention
    Severe renal insufficiency (with oliguria/anuria)
    Uncompensated cardiac failure
    Hyponatraemia or hypochloraemia
    General oedema and ascitic cirrhosis
    Clinically significant hyperglycaemia. The solution is also contraindicated in case of uncompensated diabetes, other known glucose intolerances (such as metabolic stress situations), hyperosmolar coma or hyperlactataemia.


    Special Precautions

    GHypokalaemia
    The infusion of Sodium chloride 0.9% w/v and Glucose 5% w/v solution may result in hypokalaemia. Close clinical monitoring may be warranted in patients with or at risk for hypokalaemia, for example:
    -Persons with metabolic alkalosis
    -Persons with thyrotoxic periodic paralysis. Administration of intravenous glucose has been associated in aggravating hypokalaemia
    -Persons with increased gastrointestinal losses (e.g., diarrhea, vomiting)
    -Prolonged low potassium diet
    -Persons with primary hyperaldosteronism
    -Patients treated with medications that increase the risk of hypokalaemia (e.g. diuretics, beta-2 agonists or insulin)
    Sodium retention, fluid overload and oedema
    Sodium chloride 0.9% w/v and Glucose 5% w/v solution should be used with particular caution in
    -Patients with metabolic acidosis
    -Patients at risk of
    -Hypernatraemia
    -Hyperchloraemia
    -Hypervolaemia
    -Patients with conditions that may cause sodium retention, fluid overload and oedema (central and peripheral), such as
    +Primary hyperaldosteronism,
    +secondary hyperaldosteronism associated with, for example,
    -hypertension,
    -congestive heart failure,
    -liver disease (including cirrhosis),
    -renal disease (including renal artery stenosis, nephrosclerosis)
    -Pre-eclampsia.
    Patients taking medications that may increase the risk of sodium and fluid retention, such as corticosteroids
    Hyperosmolality, serum electrolytes and water imbalance
    Depending on the volume, rate of infusion, the patient’s underlying clinical condition and capability to metabolize glucose, administration of Sodium chloride 0.9% w/v and Glucose 5% w/v solution can cause:
    -Hyperosmolality, osmotic diuresis and dehydration
    -Electrolyte disturbances such as
    + hyponatraemia (see “Sodium imbalance” below)
    + hypokalaemia (see above)
    + hypophosphataemia,
    + hypomagnesaemia
    -Acid-base imbalance
    -Overhydration/hypervolaemia and, for example, congested states, including central (e.g. pulmonary congestion) and peripheral oedema.
    -An increase in serum glucose concentration is associated with an increase in serum osmolality. Osmotic diuresis associated with hyperglycaemia can result in or contribute to the development of dehydration and in electrolyte losses.
    Electrolyte balance (see ‘Sodium imbalance’ below)
    Glucose intravenous infusions are usually isotonic solutions. In the body, however, glucose containing fluids can become extremely physiologically hypotonic due to rapid glucose metabolization. Depending on the tonicity of the solution, the volume and rate of infusion and depending on a patient’s underlying clinical condition and capability to metabolize glucose, intravenous administration of glucose can cause electrolyte disturbances most importantly hypo- or hyperosmotic hyponatraemia.
    Hyponatraemia:
    Patients with non-osmotic vasopressin release (e.g. in acute illness, pain, post-operative stress, infections, burns, and CNS diseases), patients with heart-, liver- and kidney diseases and patients exposed to vasopressin agonists are at particular risk of acute hyponatraemia upon infusion of hypotonic fluids.
    Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (brain oedema) characterized by headache, nausea, seizures, lethargy and vomiting. Patients with brain oedema are at particular risk of severe, irreversible and life-threatening brain injury. Children, women in the fertile age and patients with reduced cerebral compliance (e.g. meningitis, intracranial bleeding, and cerebral contusion) are at particular risk of the severe and life-threatening brain swelling caused by acute hyponatraemia. Clinical evaluation and periodic laboratory determinations may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation.
    Hyperglycaemia
    Rapid administration of glucose solutions may produce substantial hyperglycaemia and hyperosmolar syndrome. In order to avoid hyperglycaemia the infusion rate should not exceed the patient’s ability to utilize glucose. To reduce the risk of hyperglycaemia-associated complications, the infusion rate must be adjusted and/or insulin administered if blood glucose levels exceed levels considered acceptable for the individual patient Intravenous glucose should be administered with caution in patients with, for example:
    -Impaired glucose tolerance (such as in diabetes mellitus, renal impairment, or in the presence of sepsis, trauma, or shock),
    -Severe malnutrition (risk of precipitating a refeeding syndrome, see below),
    -Thiamine deficiency, e.g., in patients with chronic alcoholism (risk of severe lactic acidosis due to impaired oxidative metabolism of pyruvate),
    -Water and electrolyte disturbances that could be aggravated by increased glucose and/or free water load
    Other groups of patients in whom Sodium chloride 0.9% w/v and Glucose 5% w/v solution should be used with caution include:
    -Patients with ischemic stroke. Hyperglycaemia has been implicated in increasing cerebral ischemic brain damage and impairing recovery after acute ischemic strokes.
    -Patients with severe traumatic brain injury (in particular during the first 24 hours following the trauma). Early hyperglycaemia has been associated with poor outcomes in patients with severe traumatic brain injury.
    -Newborns (See Paediatric glycaemia-related issues). Prolonged intravenous administration of glucose and associated hyperglycaemia may result in decreased rates of glucose-stimulated insulin secretion.
    Hypersensitivity Reactions
    -Hypersensitivity/infusion reactions, including anaphylaxis, have been reported.
    -Stop the infusion immediately if signs or symptoms of hypersensitivity/infusion reactions develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated.
    Solutions containing glucose should be used with caution in patients with known allergy to corn or corn products
    Refeeding syndrome
    Refeeding severely undernourished patients may result in the refeeding syndrome that is characterized by the shift of potassium, phosphorus, and magnesium intracellularly as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. Careful monitoring and slowly increasing nutrient intake while avoiding overfeeding can prevent these complications
    Severe renal impairment
    Sodium chloride 0.9% w/v and Glucose 5% w/v solution should be administered with particular caution to patients at risk of (severe) renal impairment. In such patients, administration may result in sodium retention and/or fluid overload.
    Paediatric use
    The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy, and should be determined by a physician experienced in paediatric intravenous fluid therapy.
    Paediatric glycaemia-related issues
    Newborns, especially those born premature and with low birth weight, are at increased risk of developing hypo- or hyperglycaemia. Close monitoring during treatment with intravenous glucose solutions is needed to ensure adequate glycaemic control, in order to avoid potential long term adverse effects.
    -Hypoglycaemia in the newborn can cause, e.g., prolonged seizures, coma, and cerebral injury
    -Hyperglycaemia has been associated with cerebral injury, including intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, increased oxygen requirements, prolonged length of hospital stay, and death.
    Paediatric hyponatraemia-related issues
    Children (including neonates and older children) are at increased risk of developing hyponatraemia as well as for developing hyponatraemic encephalopathy.
    -Hyponatraemia can lead to headache, nausea, seizures, lethargy, coma, cerebral oedema and death; therefore, acute symptomatic hyponatraemic encephalopathy is considered a medical emergency.
    -Plasma electrolyte concentrations should be closely monitored in the paediatric population
    -Rapid correction of hyponatraemia is potentially dangerous (risk of serious neurologic complications). Dosage, rate, and duration of administration should be determined by a physician experienced in paediatric intravenous fluid therapy.
    Blood
    Sodium chloride 0.9% w/v and Glucose 5% w/v solution should not be administered simultaneously with blood through the same administration set because of the possibility of
    pseudoagglutination or haemolysis.
    Geriatric use
    When selecting the volume/rate of infusion for a geriatric patient, consider that geriatric patients are generally more likely to have cardiac, renal, hepatic and other diseases or concomitant drug therapy.


    Side Effects

    Frequencies of adverse reactions cannot be estimated from the available data as all listed adverse reactions are based on spontaneous reporting.
    Adverse reactions may be associated to the medicinal product(s) added to the solution; the nature of the additive will determine the likelihood of any other adverse reactions.


    Drug interactions

    No studies have been conducted by Baxter.
    Both the glycaemic and effects on water and electrolyte balance should be taken into account when administering the solution to patients treated with other substances that affect glycaemic control or fluid and/or electrolyte balance.
    Drugs leading to an increased vasopressin effect
    The below listed drugs increase the vasopressin effect, leading to reduced renal electrolyte free water excretion and increase the risk of hospital acquired hyponatraemia following inappropriately balanced treatment with i.v. fluids
    – Drugs stimulating vasopressin release, e.g.: Chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3.4-methylenedioxy-Nmethamphetamine, ifosfamide, antipsychotics, narcotics
    – Drugs potentiating vasopressin action, e.g.: Chlorpropamide, NSAIDs, cyclophosphamide
    – Vasopressin analogues, e.g. : Desmopressin, oxytocin, terlipressin
    Other medicinal products increasing the risk of hyponatraemia also include diuretics in general and antiepileptics such as oxcarbazepine.
    Caution is advised in patients treated with
    – lithium. Renal sodium and lithium clearance may be increased during administration and can result in decreased lithium levels.
    – corticosteroids, which are associated with the retention of sodium and water (with oedema and hypertension).
    – diuretics, beta-2 agonist, or insulin, whom increase the risk of hypokalemia
    – certain antiepileptic and psychotropic medications that increase the risk of hyponatraemia.


    Pregnancy and Lactation

    Pregnancy
    Intrapartum maternal intravenous glucose infusion may result in foetal hyperglycaemia and metabolic acidosis as well as rebound neonatal hypoglycaemia due to foetal insulin production.
    Should be administrated with special caution for pregnant women during labour particularly if administered in combination with oxytocin due to the risk of hyponatraemia.
    Lactation:
    The solution can be used during breast-feeding. The potential risks and benefits for each specific patient should be carefully considered before administration.
    Fertility
    There is no information on the effects of the solution for Infusion Baxter on fertility.


    Overdose

    Overdose of the solution can cause:
    Hyperglycaemia, adverse effects on water and electrolyte balance, and corresponding complications. For example, severe hyperglycaemia and severe dilutional hyponatraemia, and their complications, can be fatal.
    Hyponatraemia (which can lead to CNS manifestations, including seizures, coma, cerebral oedema and death).
    Fluid overload (which can lead to central and/or peripheral oedema).
    When assessing an overdose, any additives in the solution must also be considered.
    Clinically significant overdose of Sodium Chloride 0.45 % and Glucose 5.0 % Solution for Infusion Baxter may therefore, constitute a medical emergency.
    Interventions include discontinuation of administration, dose reduction, administration of insulin and other measures as indicated for the specific clinical constellation.


    Manufacturer
    Bieffe Medital S.A., Spain
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