Leaflet: information for the user

Glucosalino Hipertónico Physan solution for perfusion

Sodium chloride, Anhydrous Glucose

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

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

1.What is Glucosalino Hipertónico Physan and what it is used for

2.What you need to know before starting to use Glucosalino Hipertónico Physan

3.How to use Glucosalino Hipertónico Physan

4.Possible adverse effects

5.Storage of Glucosalino Hipertónico Physan

6.Contents of the pack and additional information

Glucosalino Hipertónico Physan belongs to the group of medications called solutions that affect the electrolyte balance. Associated electrolytes with carbohydrates.

It is used as a supply of salts and water in cases where there is dehydration with moderate losses of salts and water: vomiting, diarrhea, fistulas, excessive sweating, in cases where the administration of water, carbohydrates, and salts is needed and altered sugar metabolism: ketotic vomiting, insulin coma.

No use Glucosalino Hipertónico Physan:

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

If you have:

-Extracellular hyperhydration or hypervolemia

-Fluid and sodium retention

-Severe kidney diseases.

-Heart diseases.

-Hypernatremia (excess of sodium in blood)

-Hypochloremia (excess of chloride in blood)

-General edema or ascitic cirrhosis

-Do not administer within 24 hours after suffering a head trauma.

-Uncompensated diabetes or other known glucose intolerances, hyperosmolar coma, hyperglycemia, and hyperlactacidemia.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Glucosalino Hipertónico Physan.

The solution is hypertonic with an approximate osmolarity of 586 mosmol/l.

Large volume perfusion should be performed under specific monitoring in patients with heart, lung, or kidney failure.

If you have cardiovascular decompensation or receive treatment with corticosteroids or corticotropin.

Sodium salts should be administered with caution to patients with hypertension, heart failure, peripheral or pulmonary edema, renal dysfunction, preeclampsia, or other conditions associated with sodium retention.

Due to immature renal function, premature infants and term lactants may retain an excess of sodium. Therefore, in premature infants and term lactants, repeated perfusions of sodium chloride should only be given after determination of serum sodium levels.

Perfusion of glucose solutions is contraindicated in the first 24 hours after head trauma, and blood glucose concentration should be closely monitored during episodes of intracranial hypertension.

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

If you have diabetes or kidney diseases, your doctor may request blood tests to monitor your condition, as it is necessary to control the balance of water, glucose, and salts in the body.

In diabetes, glucose solutions can be used as long as appropriate treatment has been established (insulin). Blood glucose should be regularly monitored in diabetic patients and insulin requirements adjusted.

If hyperglycemia occurs, the perfusion rate should be adjusted or insulin administered.

In prolonged treatments, provide the patient with adequate nutritional treatment.

To avoid hypokalemia produced during prolonged parenteral administration of glucosaline, potassium can be added to the glucosaline solution as a safety measure.

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

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

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

Hypotonic 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 perfusion 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, 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 Glucosalino Hipertónico Physan with other medications

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

Sodium chloride interacts with lithium salts, whose renal excretion is directly proportional to sodium levels in the body. Therefore, administration of solutions containing sodium chloride can accelerate renal excretion of lithium, leading to a decrease in the therapeutic effect of this medication.

Glucose solutions can reduce the therapeutic effect of insulin or oral antidiabetic agents (biguanides, sulfonylureas).

Administration with corticosteroids can lead to high glucose levels (hypoglycemic action) and water and sodium retention.

If glucose administration coincides with treatment with digitalis glycosides (digoxin), an increase in digitalis activity may occur, with a risk of developing digitalis intoxication due to hypokalemia that may be caused by administration of this solution if potassium is not added.

Glucose solutions should not be administered through the same perfusion equipment as whole blood, due to the risk of hemolysis and agglutination.

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

Medications that potentiate the effect of vasopressin

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

• Medications that stimulate vasopressin release; e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, 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 and lactation

Glucosalino Hipertónico Physan should be administered with special caution in pregnant women during delivery, especially if administered in combination with oxytocin, due to the risk of hyponatremia.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using a medication.

As long as administration is correct and controlled, no adverse effects are expected during pregnancy and lactation.

No epidemiological data are available at present, so it is recommended that if used during this period, it be done with caution.

Driving and operating machinery:

It is not advisable, due to its characteristics of use.

Your doctor will inform you of the most suitable dose for your needs. Generally, intravenous administration drop by drop is recommended according to your age, body weight, clinical condition, and metabolic state.

The recommended dosage is:

-for adults, elderly, and adolescents: 500 ml to 3 liters every 24 hours.

-for infants and children:

0 to 10 kg body weight: 100 ml/kg/24 h.

10 to 20 kg body weight: 1000 ml + (50 ml/kg above 10 kg)/24 h.

>20 kg body weight: 1500 ml + (20 ml/kg above 20 kg)/ 24 h.

The perfusion rate is normally 40 ml/kg/24 h for adults, elderly, and adolescents.

In pediatric patients, the perfusion rate is 5 ml/kg/h on average, but this value varies with age: 6-8 ml/kg/h for children under 12 months, 4-6 ml/kg/h for children 12-23 months, and 2-4 ml/kg/h for school-age children (2-11 years).

The perfusion rate should not exceed the patient's glucose oxidation capacity to avoid hyperglycemia (excess sugar in the blood). Therefore, the maximum dose ranges from 5 mg/kg/min for adults to 10-18 mg/kg/min for infants and children depending on age and total body mass.

If administered continuously in the same perfusion site, it may cause thrombophlebitis (inflammation of the veins).

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

Sodium salts should be administered with caution to patients with hypertension, heart failure, peripheral or pulmonary edema, renal dysfunction, seizures, or other conditions associated with sodium retention.

It is recommended to perform water, salt, and glucose balance controls, especially if there is cardiovascular decompensation or if receiving corticosteroid or corticotropin treatment.

If you have been administered more Glucosalino Hipertónico Physan perfusion solution than you should have:

-In case of overdose, hyperglycemia (high blood sugar concentration), glucosuria (sugar in urine), hyperhydration, or hypernatremia (high sodium concentration in blood) and generalized edema (fluid accumulation) may appear. Administration will be suspended, and symptomatic treatment will be sought.

-Prolonged or rapid administration of large volumes of solutions containing glucose may lead to hyperosmolarity (risk of loss of consciousness or mental confusion), dehydration, hyperglycemia, hyperglycosuria, and osmotic diuresis (due to hyperglycemia).

-Hyperglycemia should be closely monitored in severe cases of diabetes mellitus, and it can be prevented by reducing the dose and perfusion rate or administering insulin.

-Abuse or rapid administration may lead to excess water and sodium (hypernatremia) with a risk of edema, particularly when there is defective renal excretion of sodium. In this case, renal dialysis may be necessary.

-Rarely, hypernatremia occurs after therapeutic doses of sodium chloride. The most serious effect of hypernatremia is dehydration of the brain, which causes drowsiness and confusion that progress to seizures, coma, respiratory failure, and death. Other symptoms include reduced thirst, salivation, and lacrimation, fever, tachycardia, hypertension, headache, vertigo, fatigue, irritability, and weakness.

-Excessive administration of chloride salts may produce a loss of bicarbonate with an acidifying effect.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 915 620 420.

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

When administering this solution, it has been observed that it frequently causes hyperhydration (fluid retention) and heart failure in patients with heart disease or pulmonary edema and asymptomatic electrolyte imbalances.

A too rapid administration may cause hyperglycemia and hyperosmolar syndrome (risk of loss of consciousness or mental confusion) especially in those intolerant to glucose.

Adverse reactions associated with the administration technique may occur, including fever, infection at the injection site, local reaction or pain, venous irritation, venous thrombosis or phlebitis extending from the injection site, extravasation, and hypervolemia.

Adverse reactions may be associated with the added medications in the solution, the nature of the added medication will determine the possibility of any other undesirable effect.

Adverse Reactions

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

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

**Hospital-acquired hyponatremia may 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 that does not appear 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.

Glass bottles: No special storage conditions are required.

Polypropylene bottles: Store below 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. This will help protect the environment.

Composition of Hypertonic Glucosaline Laphysan

• The active principles are: per 100 ml, sodium chloride 0.9g, anhydrous glucose 5g.
• The other components (excipients) are: water for injectable preparations and hydrochloric acid (for pH adjustment).

The electrolytic composition is:

Sodium ion 154 mmol/l, (154 meq/l).

Chloride ion 154 mmol/l, (154 meq/l).

Theoretical osmolality: 586 mosm/l.

Theoretical calories: 200 kcal/l.

pH: 3.5-6.5.

Appearance of the product and contents of the packaging

Transparent and colorless solution, without visible particles, sterile and apyrogenic.

Hypertonic Glucosaline Physan is a perfusion solution that is presented in 100 ml containers containing 50 ml or 100 ml of solution, 250 ml, 500 ml and 1000 ml containers.

It is presented in type II glass bottles, Polypropylene bottles (Flip Off cap), Polypropylene bottles (Twin Head cap), of the following capacities:

- Bottles of 100 ml containing 50 ml or 100 ml of solution.

- Bottles of 250 ml

- Bottles of 500 ml

- Bottles of 1000 ml.

There are also clinical containers with the following presentations:

- 30 bottles of 100 ml containing 50 ml or 100 ml of solution.

- 24 bottles of 250 ml

- 10 bottles of 500 ml

- 20 bottles of 500 ml

- 10 bottles of 1000 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

LAPHYSAN, S.A.U.

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

28108 Alcobendas – Madrid, Spain

Responsible for manufacturing:

S.M. FARMACEUTICI SRL

Industrial Zone

85050 TITO – POTENZA, Italy

or

Laboratórios Basi - Indústria Farmacêutica S.A.

Manuel Lourenço Ferreira Industrial Park, Lots 8, 15 and 16

3450-232 Mortágua

Portugal

Date of the last review of this prospectus:October 2022

------------------------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals:

This medication will be administered only by specialized personnel. It will be administered by perfusion, through a central or peripheral vein.

The solution must be transparent, without particles and not contain precipitates. Do not administer otherwise.

The contents of each bottle are for a single perfusion, discard the unused fraction.

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.

Discard after a single use.

Discard partially used containers.

Do not reconnect partially used containers.

You may need 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 physiological solutions. Hypertonic Glucosaline Physan can become extremely hypotonic after administration due to glucose metabolism in the body.