Label: information for the user

Glucosa Physan 20% solution for perfusion

Anhydrous glucose

Read this label carefully before starting to use the medication, because it contains important information for you

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

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

2. What you need to know before starting to use Glucosa Physan 20%

3. How to use Glucosa Physan 20%

4. Possible adverse effects.

5. Storage of Glucosa Physan 20%

6. Contents of the package and additional information

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 supplement in parenteral nutrition, and in carbohydrate metabolism disorders (hypoglycemia, insulin coma, hepatic coma, acetone vomiting).

No use Glucosa Physan 20%:

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

- If you have been diagnosed with hypotonic dehydration, loss of electrolytes, 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 have significant alterations in glucose tolerance, including hyperosmolar coma.

Warnings and precautions

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

-The blood glucose concentration must be carefully controlled in cases of intracranial hypertension.

- In the event of acute ischemic attacks (decrease or absence of circulation in arteries), as hyperglycemia has been related to an increase in ischemic cerebral damage and difficulty in recovery.

- In shock and alterations of acid-base balance, patients should be treated by administering electrolytes before administering glucose solutions. In patients with sodium deficiency, the administration of solutions without sodium may cause peripheral circulatory collapse and oliguria (scanty urine excretion).

- Regularly scheduled controls of blood glucose, serum electrolytes, water balance, and acid-base balance are recommended, as frequent and massive administration of parenteral glucose solutions can cause fluid overload (hyperhydration) and significant ionic depletions. In this case, electrolyte supplements will be necessary.

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

- If malnutrition is present, you may have a deficiency of vitamin B1. 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 may be used as long as initial appropriate treatment (insulin) has been established. Blood glucose should be regularly monitored in diabetic patients and insulin requirements adjusted.

- 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 veins) may occur.

- Special attention should be given if used in elderly patients, as they may have impaired liver and/or kidney function.

- Do not administer by intramuscular route.

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 the rate of infusion, as well as the initial clinical condition of the patient and their ability to metabolize glucose, intravenous administration of glucose may cause electrolyte imbalances, the most important of which is hyperosmolar hyponatremia.

Hyponatremia:

Patients with non-osmotic vasopressin release (e.g., in the presence of critical states, pain, postoperative stress, infections, burns, and CNS diseases) 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 and potentially fatal brain damage.

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

Use of Glucosa Physan 20% with other medications

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

It is essential to inform your doctor if you are using any of the following medications:

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

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

- Digitalis glycosides (digoxin): If intravenous administration of glucose coincides with treatment with digitalis glycosides (digoxin), an increase in digitalis activity may occur, with a risk of developing digitalis intoxication. This is due to the hypokalemia that may be caused by glucose administration, unless potassium is added to the solution.

- Erythromycin: Glucose increases its degradation rate.

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

Medications that potentiate the effect of vasopressin:

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

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

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

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

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using any medication.

In the case of pregnancy, your doctor will decide whether to use a 20% glucose solution, as it should be used with caution in this case. Administration of glucose by intravenous route during pregnancy can elevate glucose and insulin levels, as well as acidic components in the blood of the fetus.

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 delivery, especially if administered in combination with oxytocin, due to the risk of hyponatremia.

Driving and operating machinery:

No.

Administer intravenously drop by drop, according to the clinical situation and input/output balance. (See section 6).

Hyperosmolar solutions should be administered preferably through a central route. In case of use for emergency treatment of hypoglycemia, it can be infused slowly in peripheral veins.

Dosage will be established according to medical criteria. In general, 250 –1.500 ml per day is recommended, at a rate of 20-40 drops per minute. It should not exceed 100 drops per minute.

If you have been administered moreGlucosa Physan 20%than you should:

In case ofoverdose, hyperglycemia, glucosuria, hyperhydration, or electrolyte disorders may appear. Administration will be suspended and symptomatic treatment will be sought.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

It may cause hyperglycemia, glucosuria (glucose in urine) or alterations in fluid or electrolyte balance if administered too quickly or if the volume of liquid is excessive, or in cases of metabolic insufficiency.

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

A local reaction may occur at the site of injection.

Whenever any of these adverse reactions occur, you should inform your doctor, who will evaluate whether to discontinue the medication.

If you observe these adverse effects or any other not described in this prospectus, consult your doctor or pharmacist.

Adverse Reactions

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

Central nervous system disorders with hypnatremic encephalopathy** of unknown frequency.

** Hospital-acquired hyponatremia can cause irreversible brain damage and death due to the onset of acute hypnatremic encephalopathy

Reporting 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the label after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe visible signs of deterioration.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Glucose Physan 20% Composition

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

Theoretical osmolarity: 1.112 mosm/l.

Theoretical calories: 800 kcal/l.

pH: 3.5-6.5.

Product Appearance and Packaging Content

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

Glucose Physan 20% is an intravenous infusion solution that is presented in 250 ml and 500 ml containers.

Glucose Laphysan 20% infusion solution is presented in type II glass bottles of the following capacities:

- 250 ml bottles.

- 500 ml bottles.

For Clinical Containers:

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 Responsible Manufacturer

Marketing Authorization Holder:

LAPHYSAN, S.A.U.

Anabel Segura, 11 Building A, 4th Floor, Door D

28108 Alcobendas – Madrid, Spain

Responsible Manufacturer:

S.M. FARMACEUTICI SRL

Industrial Zone

85050 TITO – POTENZA, Italy

or

LABORATORIOS BASI – INDUSTRIA FARMACÉUTICA, S.A.

Manuel Lourenço Ferreira Industrial Park, No. 8, No. 15, and No. 16

3450-232 Mortágua - Portugal

Last Review Date of this Brochure: October 2022

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This information is intended solely for healthcare professionals:

This medication will be administered only by specialized personnel. It will be administered by intravenous infusion. In case of direct administration, it will be administered through a central vein. When administered diluted to a concentration of 10% or less, it may be administered through a peripheral vein.

The solution must be transparent and not contain precipitates. Do not administer otherwise. The contents of each bottle are for a single infusion, and any unused portion must be discarded.

Use an aseptic method to administer the solution and in case of preparation of mixtures.

Before adding medications to the solution or administering simultaneously with other medications, check for any incompatibilities.

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

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