GLUCOSA PHYSAN 5% SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Glucosa Physan 5%, Solution for Infusion

Anhydrous Glucose

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 further questions, ask your doctor, pharmacist, or nurse. If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What is Glucosa Physan 5% and what is it used for

Glucosa Physan 5% belongs to the group of solutions for parenteral nutrition intended for the supply 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, in disorders of carbohydrate metabolism (hypoglycemia, insulin coma, hepatic coma, acetonemic vomiting) and as a vehicle for the administration of compatible medications.

2. What you need to know before you start using Glucosa Physan 5%

Do not use Glucosa Physan 5%:

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

• If you have been detected with hypotonic dehydration, loss of salts, or decreased urine volume.
• Within the first 24 hours after a cranial trauma.
• In states of hyperglycemia.
• In states of hyperhydration, generalized edema.
• If you have hyperlactacidemia.
• If you suffer from significant glucose tolerance disorders, including hyperosmolar coma.

Warnings and Precautions

Consult your doctor or pharmacist or nurse before starting to use Glucosa Physan 5%.

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

• In case of having suffered acute ischemic attacks (decreased or absent circulation in arteries), since hyperglycemia has been related to an increase in cerebral ischemic damage and difficulty in recovery.

• In case of shock and acid-base balance disorders, patients should be treated by administering electrolytes before the administration of glucose solutions. In patients with sodium deficiency, the administration of sodium-free solutions can cause peripheral circulatory collapse and oliguria (low urine output).

• It is recommended that regular controls of blood glucose, serum electrolytes, water balance, and acid-base balance be performed, as frequent and massive administration of parenteral glucose solutions can cause fluid overload (hyperhydration) and significant ionic depletions. In this case, it will be necessary to administer electrolyte supplements.

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

• If you have malnutrition, you may have a vitamin B1 deficiency. 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 can be used as long as you have initially received appropriate treatment (insulin). Blood glucose should be regularly monitored in diabetic patients and insulin requirements modified.

• 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 the veins) may occur.

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

• Do not administer intramuscularly.

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, volume, and infusion rate, and the patient's initial clinical condition and ability to metabolize glucose, intravenous glucose administration can cause electrolyte disturbances, the most important of which is hyperosmolar hypnatremia.

Hypnatremia:

Patients with non-osmotic release of vasopressin (e.g., in critical states, pain, postoperative stress, infections, burns, and CNS diseases), patients with heart, liver, and kidney diseases, and patients exposed to vasopressin agonists have a special risk of experiencing acute hypnatremia after infusion of hypotonic solutions.

Acute hypnatremia can cause acute hypnatremic 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, women of childbearing age, and patients with reduced cerebral distensibility (e.g., in case of meningitis, intracranial hemorrhage, and cerebral contusion) have a special risk of suffering severe and potentially fatal cerebral edema caused by acute hypnatremia.

Using Glucosa Physan 5% with other medicines

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

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

• Insulin or oral antidiabetics (biguanides, sulfonylureas): Intravenous glucose administration in patients treated with insulin or oral antidiabetics can decrease their effectiveness (antagonistic action).

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

• Digitalis glycosides (digoxin): If intravenous glucose administration coincides with treatment with digitalis glycosides (digoxin), an increase in digitalis activity can occur, with the risk of developing intoxication with these medicines. This is due to hypokalemia that can be caused by glucose administration if potassium is not added to the solution.

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

Medicines that potentiate the effect of vasopressin

The following medicines increase the effect of vasopressin, which reduces the renal excretion of water without electrolytes and increases the risk of hospital hyponatremia after inadequately balanced treatment with i.v. infusion solutions.

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

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

Other medicines that are known to increase the risk of hyponatremia are also diuretics in general and antiepileptics such as oxcarbazepine.

Pregnancy, Breastfeeding, and Fertility

Glucosa Physan 5% should be administered with special caution in pregnant women during childbirth, 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 have a baby, ask your doctor or pharmacist for advice before using this medicine.

In case of pregnancy, your doctor will decide whether to use a 5% glucose solution, as it should be used with caution in this case. The administration of glucose intravenously during pregnancy can elevate glucose and insulin levels, as well as acidic components in the fetal blood.

There is no evidence to suggest that Glucosa 5% can cause adverse effects during the breastfeeding period in the neonate. However, it is recommended to use with caution during this period.

Driving and Using Machines

Not applicable.

3. How to use Glucosa Physan 5%

Your doctor will indicate the most suitable dose for your needs. It is usually recommended to administer intravenously drop by drop according to your age, body weight, clinical situation, and metabolic state.

In adults, the maximum dose is 40 ml/kg body weight/day and the maximum infusion rate is 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 (0.2-0.36 ml of solution)/kg/min.

0-10 kg: 100 ml/kg/24h

10-20 kg: 1000 ml + 50 ml/kg/24 h for weight above 10 kg.

Above 20 kg: 1500 ml + 20 ml/kg/24h for weight above 20 kg.

(See also section 6).

If you have been administered more Glucosa Physan 5% than you should

In case of overdose, hyperglycemia, glucosuria, hyperhydration, or electrolyte disorders may appear. Administration will be discontinued and symptomatic treatment will be resorted to.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

On the other hand, the hyperglycemia resulting from rapid or excessive infusion 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 may occur at the injection site.

Whenever any of these adverse reactions occur, you should inform your doctor, who will assess whether or not to discontinue the medication.

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 you notice any of these side effects or any other not listed in this leaflet, please tell your doctor or pharmacist.

Adverse Reactions

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

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

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

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Glucosa Physan 5%

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 which is stated on the label after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Glucosa Physan 5%

• The active substance is glucose. Each 100 ml of solution contains 5 g of anhydrous glucose (5.5 g as glucose monohydrate).
• The other ingredients (excipients) are: water for injections, hydrochloric acid (for pH adjustment).

Theoretical osmolality: 278 mosm/l.

Theoretical calories: 200 kcal/l.

pH: 3.5-6.5.

Appearance of the Product and Contents of the Pack

Transparent, isotonic, apyrogenic, and sterile solution.

Glucosa Physan 5% is a solution for intravenous infusion presented in containers of 100 ml containing 50 ml or 100 ml of solution, containers of 250 ml, 500 ml, and 1000 ml.

For Unit Containers:

Presented in vials: Type II glass and polypropylene (PP).

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

In the following capacities:

• Vial and bag of 100 ml containing 50 ml or 100 ml of solution.
• Vial and bag of 250 ml
• Vial and bag of 500 ml
• Vial and bag of 1000 ml.

For Clinical Containers:

With the following presentations:

1. Glass Vials:

• 30 vials of 100 ml containing 50 ml or 100 ml of solution.
• 20 vials of 100 ml containing 50 ml or 100 ml of solution.
• 24 vials of 250 ml
• 10 vials of 250 ml
• 10 vials of 500 ml
• 10 bags of 1000 ml.

2. PP Vials:

• 30 vials of 100 ml containing 50 ml or 100 ml of solution.
• 50 vials of 100 ml containing 50 ml or 100 ml of solution.
• 20 vials of 250 ml
• 24 vials of 250 ml
• 10 vials of 500 ml
• 20 vials of 500 ml
• 10 vials of 1000 ml.

3. PP and PVC Bags:

• 50 bags of 100 ml containing 50 ml or 100 ml of solution.
• 30 bags of 250 ml
• 20 bags of 500 ml
• 10 bags of 1000 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

LAPHYSAN, S.A.U.

Anabel Segura, 11 Edificio A, Planta 4, Puerta 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, Nº8, Nº 15 y Nº 16 3450-232 Mortágua – Portugal

Date of the Last Revision of this Leaflet: March 2019

This information is intended only for healthcare professionals:

This medicine will always be administered by specialized personnel. It will be administered by infusion, through a central or peripheral vein.

The solution must be transparent and not contain precipitates. Do not administer otherwise. The contents of each vial, bottle, or bag are for single infusion; the unused fraction must be discarded.

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

Before adding medicines to the solution or administering them simultaneously with other medicines, it should be checked that there are no incompatibilities.

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

Monitoring of serum sodium is especially important when administering physiologically hypotonic solutions. Glucosa Physan 5% solution for infusion can become extremely hypotonic after administration due to glucose metabolism in the body.