Glucose Physan 20% solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Glucosa Physan 20% solution for infusion

Glucose anhydrous

Read all of this leaflet carefully before you start using 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, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Glucosa Physan 20% is and what it is used for
2. What you need to know before you use Glucosa Physan 20%
3. How to use Glucosa Physan 20%
4. Possible side effects
5. How to store Glucosa Physan 20%
6. Contents of the pack and other information

1. What Glucosa Physan 20% is and what it is used for

Glucosa Physan 20% belongs to the group of parenteral nutrition solutions intended for the provision of water and energy.

It is indicated for the treatment of hypertonic dehydration (vomiting, diarrhea, profuse sweating, gastrointestinal fistulas), as an energy source in parenteral nutrition, and in carbohydrate metabolism disorders (hypoglycemia, insulin coma, hepatic coma, ketotic vomiting).

2. What you need to know before starting to use 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 diagnosed with hypotonic dehydration, salt loss, or reduced urine volume.
• During the first 24 hours after head trauma.
• In cases of hyperglycemia.
• In conditions of hyperhydration or generalized edema.
• If you have hyperlactacidemia.
• If you suffer from significant disturbances in glucose tolerance, including hyperosmolar coma.

Warnings and precautions

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

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

• If you have suffered acute ischemic events (reduced or absent blood flow in arteries), since hyperglycemia has been associated with increased cerebral ischemic damage and impaired recovery.

• In cases of shock or acid-base imbalances, patients should be treated with electrolytes prior to administration of glucose solutions. In patients with sodium deficit, administration of sodium-free solutions may cause peripheral circulatory collapse and oliguria (low urine output).

• Regular monitoring of blood glucose, serum electrolytes, fluid balance, and acid-base balance is recommended, as frequent and massive administration of parenteral glucose solutions may lead to fluid overload (hyperhydration) and significant ionic depletions. In such cases, electrolyte supplementation may be necessary.

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

• If you suffer from malnutrition, you may have a deficiency in vitamin B1 (thiamine). This vitamin is essential for glucose metabolism, and if necessary, this deficiency should be corrected first.

• If you have diabetes. In such cases, glucose solutions may be used provided that appropriate initial treatment (insulin) has been established. Blood glucose must be regularly monitored in diabetic patients, and insulin requirements adjusted accordingly.

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

• If administered continuously at the same infusion site, thrombophlebitis (vein inflammation) may occur.

• Special caution is required when used in elderly patients, as they may have impaired hepatic and/or renal function.

• Do not administer by intramuscular route.

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

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

Hyponatremia:

Patients with non-osmotic release of vasopressin (e.g., in critical conditions, pain, postoperative stress, infections, burns, and CNS disorders), patients with heart, liver, or kidney disease, and patients exposed to vasopressin agonists are at special risk of developing 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 at particular risk of severe, irreversible, and potentially fatal brain damage.

Children, women of childbearing age, and patients with reduced cerebral compliance (e.g., in cases of meningitis, intracranial hemorrhage, or cerebral contusion) are at special risk of severe and potentially fatal cerebral edema caused by acute hyponatremia.

Use of Glucosa Physan 20% with other medicines

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

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

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

• Corticosteroids: Intravenous administration of glucose solutions in patients treated with systemic corticosteroids with glucocorticoid activity (e.g., cortisol) may lead to a significant increase in plasma glucose levels due to the hyperglycemic effect of these agents. As for corticosteroids with mineralocorticoid activity, they should be administered with caution due to their capacity 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, increasing the risk of toxicity. This is due to hypokalemia that may result from glucose administration if potassium is not added to the solution.

• Erythromycin: Glucose increases its degradation rate.

In any case, the physician must verify the compatibility of any added medications.

Medicines that potentiate the effect of vasopressin:

The following medicines increase the effect of vasopressin, thereby reducing renal excretion of electrolyte-free water and increasing the risk of hospital-acquired hyponatremia during inadequately balanced intravenous infusion therapy:

• Medicines that stimulate vasopressin release; e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine (MDMA), ifosfamide, antipsychotics, narcotics

• Medicines that enhance vasopressin action; e.g.: chlorpropamide, NSAIDs, cyclophosphamide

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

Other medicines known to increase the risk of hyponatremia include diuretics in general and antiepileptic drugs such as oxcarbazepine.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

During pregnancy, your doctor will decide whether the use of 20% glucose solution is appropriate, as it should be used with caution in such cases. Intravenous glucose administration during pregnancy may increase glucose and insulin levels, as well as acidic components, in fetal blood.

There is no evidence suggesting that 20% Glucose may cause adverse effects in the neonate during breastfeeding. Nevertheless, caution is recommended 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 use of machines:

Not applicable.

3. How to use Glucosa Physan 20%

Intravenous infusion drop by drop, according to the clinical condition and fluid balance in and out. (see section 6).

Hypertonic solutions should preferably be administered through a central route. However, in emergency treatment of hypoglycemia, slow infusion into peripheral veins may be performed.

Dosage will be determined according to medical judgment. Generally, 250–1,500 mL per day at a rate of 20–40 drops per minute is recommended. The rate 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, glycosuria, hyperhydration, or electrolyte disturbances may occur. Administration should be discontinued and symptomatic treatment initiated.

In case of overdose, contact the Toxicology Information Service. Telephone: 91 562 04 20.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

Hyperglycaemia, glycosuria (glucose in urine), or disturbances in fluid or electrolyte balance may occur if the solution is administered too rapidly, if the fluid volume is excessive, or in cases of metabolic insufficiency.

Moreover, hyperglycaemia resulting from rapid infusion or excessive volume should be monitored in severe cases of diabetes mellitus, and can be avoided by reducing the dose and infusion rate or by administering insulin.

A local reaction at the injection site may occur.

Whenever any of these adverse reactions occur, you should inform your doctor, who will assess whether it is necessary to discontinue the treatment.

If these adverse effects or any others not described in this leaflet occur, consult your doctor or pharmacist.

Adverse reactions

Metabolism and nutrition disorders: hospital-acquired hyponatraemia**, frequency not known.

Nervous system disorders: hyponatraemic encephalopathy**, frequency not known.

** Hospital-acquired hyponatraemia may cause irreversible brain damage and death due to the development of acute hyponatraemic encephalopathy.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the label after EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if there are any visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This helps 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 components (excipients) are: water for injections, hydrochloric acid (for pH adjustment).

Theoretical osmolarity: 1,112 mosm/l.

Theoretical calories: 800 kcal/l.

pH: 3.5–6.5.

Appearance of the product and contents of the container

A clear, colourless to slightly yellow, hypertonic, apyrogenic and sterile solution.

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

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

• Bottles of 250 ml.
• Bottles of 500 ml.

For Clinical Packs:

1.- Glass Bottles:

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

2.- PP Bottles:

• 20 bottles of 500 ml.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder:

LAPHYSAN, S.A.U.

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

28108 Alcobendas – Madrid, Spain

Manufacturing Responsible Party:

S.M. FARMACEUTICI SRL

Zona industriale

85050 TITO – POTENZA, Italy

or

LABORATORIOS BASI – INDUSTRIA FARMACÉUTICA, S.A.

Parque Industrial Manuel Lourenço Ferreira,

Nos 8, 15 and 16

3450-232 Mortágua - Portugal

Date of the most recent review of this package leaflet: October 2022

This information is intended for healthcare professionals only:

This medicinal product must always be administered by specialized personnel. It is administered by intravenous infusion. When administered directly, it must be given through a central vein. When diluted to a concentration of 10% or less, it may be administered through a peripheral vein.

The solution must be clear and free from precipitates. Do not administer if otherwise. The content of each vial is intended for single infusion use only; any unused portion must be discarded.

An aseptic technique must be used when administering the solution and when preparing mixtures.

Before adding other medicinal products to the solution or administering concomitantly with other drugs, compatibility must be verified to ensure no incompatibilities exist.

Monitoring of fluid balance, serum glucose, serum sodium, and other electrolytes may be required before and during administration, particularly in patients with non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant treatment with vasopressin agonists due to the risk of hyponatremia.

Serum sodium monitoring is especially important when physiologically hypotonic solutions are administered. Glucosa Physan 20% solution for infusion may become extremely hypotonic after administration due to glucose metabolism in the body.