Glucose Physan 10% solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Glucosa Physan 10%, solution for infusion

Glucose anhydrous

Read this entire leaflet carefully before you start using this medicine, as 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 side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Glucosa Physan 10% is and what it is used for
2. What you need to know before you start using Glucosa Physan 10%
3. How to use Glucosa Physan 10%
4. Possible side effects
5. How to store Glucosa Physan 10%
6. Contents of the pack and other information

1. What Glucosa Physan 10% is and what it is used for

Glucosa Physan 10% 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, in carbohydrate metabolism disorders (hypoglycemia, insulin coma, hepatic coma, ketotic vomiting), and as a vehicle for the administration of compatible medications.

2. What you need to know before using Glucosa Physan 10%

Do not use Glucosa Physan 10%:

If you are allergic to anhydrous glucose or 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 following head trauma.
• In states 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 10%.

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

• If you have suffered acute ischemic events (reduced or absent blood flow in arteries), as 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 lead to peripheral circulatory collapse and oliguria (low urine output).

• Regular monitoring of blood glucose, serum electrolytes, fluid balance, and acid-base equilibrium is recommended, since frequent and large intravenous infusions of glucose solutions may cause fluid overload (hyperhydration) and significant ionic depletions. In such cases, electrolyte supplementation may be necessary.

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

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

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

• Do not administer blood simultaneously using the same infusion equipment 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 liver and/or kidney function.

• Do not administer by intramuscular route.

Intravenous glucose solutions for infusion are generally isotonic. However, in the body, glucose solutions may become physiologically extremely hypotonic 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 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 central nervous system diseases), 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, and cerebral contusion) are at special risk of developing severe and potentially fatal cerebral edema due to acute hyponatremia.

Use of Glucosa Physan 10% with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

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 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 effect of these agents. As for corticosteroids with mineralocorticoid activity, they should be used with caution due to their capacity to retain water and sodium.

• Digitalis glycosides (digoxin): If intravenous glucose is administered concurrently with digitalis glycosides (digoxin), increased 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.

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

Medicines that enhance 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, ifosfamide, antipsychotics, narcotics
• Medicines that potentiate vasopressin action; 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, breastfeeding, and fertility

Glucosa Physan 10% 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 are planning to become pregnant, consult your doctor or pharmacist before using any medicine.

During pregnancy, your doctor will decide whether the use of 10% glucose solution is appropriate, as it should be used with caution in this case. Intravenous glucose administration during pregnancy may increase glucose and insulin levels, as well as acid components, in fetal blood.

There is no evidence suggesting that 10% glucose may cause adverse effects in the neonate during lactation. Nevertheless, caution is recommended during this period.

Driving and use of machines:

Not applicable.

3. How to use Glucosa Physan 10%

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

In adults, the maximum dose is 20 ml/kg body weight/day and the maximum infusion rate is

2.5 ml/kg body weight/hour = 0.25 g/kg body weight/hour.

Use in children

In children, the infusion rate depends on the child's age and weight, and generally should not exceed 10–18 mg of glucose (0.1–0.18 ml of solution)/kg/min.

0–10 kg: 50 ml/kg/24h

10–20 kg: 500 ml + 25 ml/kg/24h for weight above 10 kg.

Over 20 kg: 750 ml + 10 ml/kg/24h for weight above 20 kg.

(See also section 6).

If you have been administered more Glucosa Physan 10% than you should have:

In case of overdose, hyperglycemia, glucosuria, 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 can cause adverse effects, although not everyone will experience them.

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

Moreover, hyperglycemia 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, inform your doctor, who will assess whether it is necessary or not to discontinue the treatment.

If used as a vehicle for the administration of other medicines, the nature of the added medicines will determine the likelihood of other adverse reactions.

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

Adverse reactions

Metabolism and nutrition disorders: hospital-acquired hyponatremia** with unknown frequency.

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

** Hospital-acquired hyponatremia can cause irreversible brain damage and death due to the development of 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 can 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 10%

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

No special storage conditions are required.

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 medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Glucosa Physan 10%

• The active substance is glucose. Each 100 ml of solution contains 10 g of anhydrous glucose (11 g as glucose monohydrate).
• The other components (excipients) are: water for injections, hydrochloric acid (for pH adjustment).

Theoretical osmolarity: 556 mosm/l. Theoretical calories: 400 kcal/l.

pH: 3.5–6.5

Appearance of the product and contents of the package

Clear, hypertonic, pyrogen-free, sterile solution.

Glucosa Physan 10% is an intravenous infusion solution supplied in 250 ml and 500 ml containers.

For single-use containers:

Available in bottles: Type II glass and polypropylene (PP).

Also in bags: Polypropylene (PP) and polyvinyl chloride (PVC).

Available in the following sizes:

• 250 ml bottle and bag
• 500 ml bottle and bag

For Clinical Packs:

Available in the following presentations:

1.- Glass Bottles:

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

2.- PP Bottles:

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

3.- PP and PVC Bags:

• 30 bags of 250 ml
• 20 bags of 500 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

SALF SPA LABORATORIO FARMACOLOGICO
Via Marconi 2
24069 Cenate Sotto (Bergamo), Italy

or

PARACELSIA INDUSTRIA FARMACEUTICA
Rua Antero de Quental, 639
P-4200-068 Porto, Portugal

or

LABORATORIOS BASI - INDUSTRIA FARMACÉUTICA, S.A.
Parque Industrial Manuel Lourenço Ferreira, Nº 8, Nº 15 and Nº 16
3450-232 Mortágua – Portugal

Date of the most recent revision of this leaflet: March 2019

This information is intended for healthcare professionals only:

This medicine must always be administered by trained healthcare personnel. It is administered by intravenous infusion, either through a central or peripheral vein.

The solution must be clear and free from precipitates. Do not administer if this is not the case. The contents of each bottle, vial, or bag are intended for single use only; any unused portion must be discarded.

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

Before adding medications to the solution or administering it concomitantly with other medicinal products, compatibility must be verified to rule out incompatibilities.

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. Glucosa Physan 10% solution for infusion may become extremely hypotonic after administration due to the metabolism of glucose in the body.