Glucosaline hypertonic Physan solution for infusion

Patient Information Leaflet

Introduction

Patient Information Leaflet

Glucosalino Hipertónico Physan infusion solution

Sodium chloride, Anhydrous glucose

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you

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

Leaflet Contents

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

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

Glucosalino Hipertónico Physan belongs to the group of medicines known as electrolyte balance-affecting solutions. Electrolytes associated with carbohydrates.

It is used to provide salts and water in cases of dehydration with moderate losses of salts and water: vomiting, diarrhoea, fistulas, excessive sweating, and in situations requiring administration of water, carbohydrates, and salts with altered sugar metabolism: ketotic vomiting, insulin coma.

2. What you need to know before using Glucosalino Hipertónico Physan

Do not use Glucosalino Hipertónico Physan:

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

If you have:

• Extracellular hyperhydration or hypervolemia
• Fluid and sodium retention
• Severe kidney diseases
• Heart diseases
• Hypernatremia (excess sodium in blood)
• Hyperchloremia (excess chloride in blood)
• Generalized edema or ascitic cirrhosis
• Must not be administered within 24 hours following head trauma
• Decompensated 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.

Infusion of large volumes should be performed under specific monitoring in patients with heart, lung, or kidney failure.

If you have cardiovascular decompensation or are receiving treatment with corticosteroids or corticotropin.

Sodium salts should be administered cautiously in patients with hypertension, cardiac failure, peripheral or pulmonary edema, renal dysfunction, preeclampsia, or other conditions associated with sodium retention.

Due to immature renal function, preterm infants and full-term neonates may retain excess sodium. Therefore, repeated infusions of sodium chloride in preterm and full-term infants should only be given after determination of serum sodium levels.

Infusion of glucose solutions is contraindicated during the first 24 hours after head trauma, and blood glucose concentration must be carefully monitored during episodes of intracranial hypertension.

In case of recent acute ischemic events (reduced or absent arterial circulation), as hyperglycemia has been associated with increased cerebral ischemic damage and impaired recovery.

If you have diabetes or kidney disease, your doctor may request blood tests to monitor your condition, as water, glucose, and electrolyte balance in the body must be controlled.

In diabetes, glucose solutions may be used provided appropriate treatment (insulin) has been initiated. Blood glucose must be regularly monitored in diabetic patients, and insulin requirements adjusted accordingly.

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

In prolonged treatments, adequate nutritional support should be provided to the patient.

To prevent hypokalemia caused by prolonged parenteral administration of glucosaline, potassium may be added to the glucosaline solution as a safety measure.

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

Intravenous glucose infusion solutions are generally isotonic. However, in the body, glucose solutions may become extremely hypotonic physiologically due to the rapid metabolism of glucose.

Depending on the tonicity of the solution, volume and rate of infusion, and the patient's initial clinical status 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 diseases, 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 suffering 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, and cerebral contusion) are at special risk of developing severe and potentially fatal cerebral edema due to acute hyponatremia.

Use of Glucosalino Hipertónico Physan with other medicines

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

Sodium chloride interacts with lithium salts, whose renal excretion is directly proportional to body sodium levels. Thus, administration of solutions containing sodium chloride may accelerate renal excretion of lithium, leading to reduced therapeutic effect.

Solutions containing glucose may reduce the therapeutic efficacy of insulin or oral antidiabetics (biguanides, sulfonylureas).

Concomitant administration with corticosteroids may lead to high glucose levels (hyperglycemic effect) and water and sodium retention.

If glucose administration coincides with treatment with digitalis glycosides (digoxin), increased digitalis activity may occur, with risk of toxicity due to hypokalemia that may result from this solution if potassium is not added.

Glucose-containing solutions must not be administered through the same infusion equipment as whole blood due to the risk of hemolysis and agglutination.

In any case, the physician must verify the compatibility of 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 following 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 the action of vasopressin; e.g.: chlorpropamide, NSAIDs, cyclophosphamide
• Vasopressin analogs; 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 and breastfeeding

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

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

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

To date, relevant epidemiological data are lacking; therefore, it is recommended to use this medicine with caution during this period.

Driving and use of machines:

Not applicable, due to the nature of its use.

3. How to use Glucosalino Hipertónico Physan

Your doctor will determine the most appropriate dose for your needs. Generally, intravenous drop-by-drop administration is recommended, adjusted according to your age, body weight, clinical condition, and metabolic status.

The recommended dosage is:

• For adults, elderly patients, and adolescents: 500 ml to 3 liters every 24 hours.

• For infants and children:

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

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

  • 20 kg body weight: 1500 ml + (20 ml/kg for each kg above 20 kg)/24 h.

The usual infusion rate is 40 ml/kg/24 h in adults, elderly patients, and adolescents.

In pediatric patients, the infusion rate is typically 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 aged 12–23 months, and 2–4 ml/kg/h for school-aged children (2–11 years).

The infusion rate must not exceed the patient's glucose oxidation capacity in order to avoid hyperglycemia (excess blood sugar). 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 at the same infusion site, thrombophlebitis (vein inflammation) may occur.

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

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

It is advisable to monitor fluid, electrolyte, and glucose balance, especially in cases of cardiovascular decompensation or when receiving treatment with corticosteroids or corticotropin.

If you have been administered more Glucosalino Hipertónico Physan infusion 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 occur. Administration should be discontinued and symptomatic treatment initiated.

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

• Hyperglycemia should be closely monitored in severe cases of diabetes mellitus and can be prevented by reducing the dose and infusion rate or by administering insulin.

• Abuse or excessively rapid administration may result in excess water and sodium (hypernatremia), with risk of edema, particularly when renal sodium excretion is impaired. In such cases, extrarenal dialysis may be necessary.

• Hypernatremia rarely occurs after therapeutic doses of sodium chloride. The most serious effect of hypernatremia is brain dehydration, which causes somnolence and confusion progressing to seizures, coma, respiratory failure, and death. Other symptoms include thirst, reduced salivation and lacrimation, fever, tachycardia, hypertension, headache, dizziness, fatigue, irritability, and weakness.

• Excessive administration of chloride salts may lead to bicarbonate loss, resulting in an acidifying effect.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 915 620 420.

4. Possible adverse effects

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

When administering this solution, it has been observed that fluid retention (hyperhydration) and heart failure may frequently occur in patients with heart disease, as well as pulmonary edema and asymptomatic electrolyte disturbances.

Too rapid administration may cause hyperglycemia and hyperosmolar syndrome (risk of loss of consciousness or mental confusion), especially in patients with glucose intolerance.

Adverse reactions related to 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 also be related to any added medications; the nature of the added substance will determine the possibility of additional undesirable effects.

Adverse reactions

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

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

** Hospital-acquired hyponatremia may cause irreversible brain damage and death due to acute hyponatremic 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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Glucosalino Hypertonic Physan

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

Glass bottles: No special storage conditions required.

Polypropylene bottles: Store below 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 you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Glucosalino Hipertónico Laphysan

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

Electrolytic composition:

Sodium ion 154 mmol/l (154 mEq/l).

Chloride ion 154 mmol/l (154 mEq/l).

Theoretical osmolarity: 586 mOsm/l.

Theoretical calories: 200 kcal/l.

pH: 3.5–6.5.

Nature of the product and contents of the container

Clear, colourless solution, free from visible particles, sterile and pyrogen-free.

Glucosalino Hipertónico Physan is an infusion solution available in containers of 100 ml containing 50 ml or 100 ml of solution, as well as 250 ml, 500 ml and 1000 ml containers.

It is supplied in Type II glass bottles, polypropylene bottles (Flip-Off cap), and polypropylene bottles (twin-head cap) with 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

Clinical packs are also available in 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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

LAPHYSAN, S.A.U.

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

28108 Alcobendas – Madrid, Spain

Manufacturer:

S.M. FARMACEUTICI SRL

Zona industriale

85050 TITO – POTENZA, Italy

or

Laboratórios Basi - Indústria Farmacêutica S.A.

Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16

3450-232 Mortágua

Portugal

Date of the most recent revision of this leaflet: October 2022

This information is intended for healthcare professionals only:

This medicine will always be administered by trained personnel. It is administered by intravenous infusion via a central or peripheral vein.

The solution must be clear, free from particles and precipitates. Do not administer if this is not the case.

The contents of each bottle are intended for single use only; any unused portion must be discarded.

Use an aseptic technique when administering the solution and when preparing mixtures.

Before adding medications to the solution or co-administering with other medicines, compatibility must be verified to ensure no incompatibilities exist.

Discard after single use.

Discard partially used containers.

Do not reconnect partially used containers.

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

Monitoring of serum sodium is especially important when physiologically hypotonic solutions are administered. Glucosalino Hipertónico Physan may become extremely hypotonic after administration due to the metabolism of glucose in the body.