GLUCOSA PHYSAN 20% SOLUTION FOR INFUSION

2. What you need to know before you start using Glucosa Physan 20%

Do not use Glucosa Physan 20%:

If you are allergic to anhydrous glucose or to any of the other components of this medicine (listed in section 6).

• If you have been detected with hypotonic dehydration, loss of salts, or decreased urine volume.
• In the first 24 hours after a head trauma.
• In states of hyperglycemia.
• In states of hyperhydration, generalized edema.
• If you have hyperlactacidemia.
• If you suffer from significant glucose tolerance disorders, including hyperosmolar coma.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Glucosa Physan 20%.

• Blood glucose concentration should be carefully monitored in cases of intracranial hypertension.

• In case of having suffered acute ischemic attacks (decreased or absent circulation in arteries), since hyperglycemia has been related to an increase in cerebral ischemic damage and difficulty in recovery.

• In case of shock and acid-base balance disorders, patients should be treated by administering electrolytes before the administration of glucose solutions. In patients with sodium deficiency, the administration of sodium-free solutions may cause peripheral circulatory collapse and oliguria (scant urine excretion).

• It is recommended that regular checks of blood glucose, serum electrolytes, water balance, and acid-base balance be performed, as frequent and massive administration of parenteral glucose solutions can cause fluid overload (hyperhydration) and significant ionic depletions. In this case, it will be necessary to administer electrolyte supplements.

• To avoid hypokalemia produced during prolonged parenteral nutrition with glucose, potassium may be added to the glucose solution as a safety measure.

• If you have malnutrition, you may have a vitamin B1 deficiency. This vitamin is essential for glucose metabolism, so if necessary, this deficiency should be corrected first.

• If you have diabetes. In this case, glucose solutions can be used as long as you have initially been given the appropriate treatment (insulin). Blood glucose should be regularly monitored in diabetic patients and insulin requirements modified.

• Do not administer blood simultaneously using the same infusion equipment due to the risk of pseudoagglutination and/or hemolysis.

• If administered continuously in the same infusion site, thrombophlebitis (inflammation of the veins) may occur.

• Special attention should be paid if used in elderly patients, as they may have affected liver and/or kidney function.

• Do not administer intramuscularly.

Glucose solutions for intravenous infusion are generally isotonic. However, in the body, glucose solutions can become extremely hypotonic physiologically due to the rapid metabolism of glucose.

Depending on the tonicity of the solution, the volume and rate of infusion, and the patient's initial clinical condition and ability to metabolize glucose, intravenous glucose administration can cause electrolyte disturbances, the most important of which is hyperosmolar hyponatremia.

Hyponatremia:

Patient with non-osmotic release of vasopressin (e.g., in critical states, pain, postoperative stress, infections, burns, and CNS diseases), patients with heart, liver, and kidney diseases, and patients exposed to vasopressin agonists have a special risk of experiencing acute hyponatremia after infusion of hypotonic solutions.

Acute hyponatremia can cause acute hyponatremic encephalopathy (cerebral edema) characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema have a special risk of suffering severe, irreversible, and potentially fatal brain damage.

Children, women of childbearing age, and patients with reduced cerebral distensibility (e.g., in case of meningitis, intracranial hemorrhage, and cerebral contusion) have a special risk of suffering severe and potentially fatal cerebral edema caused by acute hyponatremia.

Using Glucosa Physan 20% with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

It is important that you inform your doctor if you are using any of the following medicines:

• Insulin or oral antidiabetics (biguanides, sulfonylureas): Intravenous glucose administration in patients treated with insulin or oral antidiabetics may decrease their effectiveness (antagonistic action).

• Corticosteroids: Intravenous administration of glucose solutions in patients treated with systemic corticosteroids with glucocorticoid activity (cortisol) may result in a significant increase in plasma glucose levels due to the hyperglycemic action of these latter. As for corticosteroids with mineralocorticoid activity, they should be administered with caution due to their ability to retain water and sodium.

• Digitalis glycosides (digoxin): If intravenous glucose administration coincides with treatment with digitalis glycosides (digoxin), an increase in digitalis activity may occur, with the risk of developing intoxication with these medicines. This is due to the hypokalemia that can be caused by glucose administration if potassium is not added to the solution.

• Erythromycin: Glucose increases its degradation rate.

In any case, the doctor should check the compatibility of the added medicines.

Medicines that potentiate the effect of vasopressin:

The following medicines increase the effect of vasopressin, which reduces the renal excretion of water without electrolytes and increases the risk of hospital hyponatremia after inadequately balanced treatment with intravenous infusion solutions.

• Medicines that stimulate the release of vasopressin; e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxymethamphetamine, ifosfamide, antipsychotics, narcotics.
• Medicines that potentiate the action of vasopressin; e.g.: chlorpropamide, NSAIDs, cyclophosphamide.

• Vasopressin analogs; e.g.: desmopressin, oxytocin, vasopressin, terlipressin.

Other medicines that are known to increase the risk of hyponatremia are diuretics in general and antiepileptics such as oxcarbazepine.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using any medicine.

In case of pregnancy, your doctor will decide whether to use a 20% glucose solution, as it should be used with caution in this case. The administration of glucose intravenously during pregnancy may increase glucose and insulin levels, as well as acidic components in the fetal blood.

There is no evidence to suggest that 20% Glucose may cause adverse effects during the lactation period in the neonate. However, it is recommended to use with caution during this period.

Glucosa Physan 20% should be administered with special caution in pregnant women during labor, especially if administered in combination with oxytocin, due to the risk of hyponatremia.

Driving and Using Machines

Not applicable.

3. How to use Glucosa Physan 20%

Intravenous drip administration, according to the clinical situation and input/output balance (see section 6).

Hypertonic solutions should be administered preferably through a central vein. In case of emergency treatment of hypoglycemia, it can be infused slowly into peripheral veins.

Dosage will be established according to medical criteria. In general, it is recommended to administer 250-1,500 ml per day, at a rate of 20-40 drops per minute. It should not exceed 100 drops per minute.

If you have been administered more Glucosa Physan 20% than you should have:

In case of overdose, hyperglycemia, glucosuria, hyperhydration, or electrolyte disorders may appear. Administration will be discontinued and symptomatic treatment will be provided.

In case of overdose, consult the Toxicology Information Service. Phone: 91 562 04 20.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Hyperglycemia, glucosuria (glucose in urine), or disturbances in fluid or electrolyte balance may occur if administered too quickly or if the fluid volume is excessive, or in cases of metabolic insufficiency.

On the other hand, the hyperglycemia resulting from rapid or excessive infusion should be monitored in severe cases of diabetes mellitus, and can be avoided by reducing the dose and rate of infusion or by administering insulin.

A local reaction may occur at the injection site.

Whenever any of these adverse reactions occur, you should inform your doctor, who will assess whether or not to discontinue the medication.

If you experience any of these side effects or any other not listed in this leaflet, consult your doctor or pharmacist.

Adverse Reactions

Metabolic and nutritional disorders with hospital hyponatremia** of unknown frequency.

Nervous system disorders with hyponatremic encephalopathy** of unknown frequency.

** Hospital hyponatremia can cause irreversible brain damage and death due to the occurrence of acute hyponatremic encephalopathy.

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Glucosa Physan 20%

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date is the last day of the month shown.

Do not use this medicine if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

Composition of Glucosa Physan 20%

• The active substance is glucose. Each 100 ml of solution contains 20 g of anhydrous glucose (22 g as glucose monohydrate).
• The other ingredients (excipients) are: water for injectable preparations, hydrochloric acid (for pH adjustment).

Theoretical osmolality: 1.112 mosm/l.

Theoretical calories: 800 kcal/l.

pH: 3.5-6.5.

Appearance of the Product and Contents of the Pack

Clear, colorless to slightly yellowish, hypertonic, apyrogenic, and sterile solution.

Glucosa Physan 20% is a solution for intravenous infusion presented in 250 ml and 500 ml containers.

Glucosa Laphysan 20% solution for infusion is presented in type II glass vials of the following capacities:

• 250 ml vials.
• 500 ml vials.

For Clinical Containers:

1. Glass Vials:

• 24 vials of 250 ml.
• 10 vials of 500 ml.

2. PP Vials:

• 20 vials of 500 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

LAPHYSAN, S.A.U.

Anabel Segura, 11 Edificio A, Planta 4, Puerta D

28108 Alcobendas – Madrid, Spain

Manufacturer:

S.M. FARMACEUTICI SRL

Zona industriale

85050 TITO – POTENZA, Italy

or

LABORATORIOS BASI – INDUSTRIA FARMACÉUTICA, S.A.

Parque Industrial Manuel Lourenço Ferreira,

Nº 8, Nº 15 y Nº 16

3450-232 Mortágua - Portugal

Date of the Last Revision of this Leaflet: October 2022

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This information is intended only for healthcare professionals:

This medicine will always be administered by specialized personnel. It will be administered by intravenous infusion. If administered directly, it will be through a central vein. When administered diluted to a concentration of 10% or less, a peripheral vein can be used.

The solution must be transparent and not contain precipitates. Do not administer otherwise. The contents of each vial are for single infusion; the unused fraction must be discarded.

An aseptic method should be used to administer the solution and in the preparation of mixtures.

Before adding medicines to the solution or administering them simultaneously with other medicines, it should be checked that there are no incompatibilities.

It may be necessary to monitor fluid balance, blood glucose, serum sodium, and other electrolytes before and during administration, especially in patients with increased non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant medication with vasopressin agonists due to the risk of hyponatremia.

Monitoring of serum sodium is especially important when administering physiologically hypotonic solutions. Glucosa Physan 20% solution for infusion can become extremely hypotonic after administration due to glucose metabolism in the body.