GLUCOSA PHYSAN 10% SOLUTION FOR INFUSION

2. What you need to know before you start 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, loss of salts, or decreased urine volume.
• In the first 24 hours after a head injury.
• In states of hyperglycemia.
• In states of hyperhydration, generalized edema.
• If you have hyperlactacidemia.
• If you have significant glucose tolerance disorders, 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 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 ischemic cerebral 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 (scant urine excretion).

• 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 feeding 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, the volume and rate of infusion, 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 hyponatremia.

Hyponatremia:

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 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, 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 hyponatremia.

Using Glucosa Physan 10% with other medicines

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

It is important that you inform your doctor if you use 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 activity, 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 the 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 intravenous 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 diuretics in general and antiepileptics such as oxcarbazepine.

Pregnancy, Breast-feeding, and Fertility

Glucosa Physan 10% 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 breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using any medicine.

In case of pregnancy, your doctor will decide whether to use a 10% 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 10% glucose can cause adverse effects during the lactation 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 10%

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 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/24 h for weight above 10 kg.

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

(See also section 6).

If you have been given too much Glucosa Physan 10%:

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

In case of overdose, consult the Toxicology 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 suspend 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 mentioned in this leaflet, please tell your doctor or pharmacist.

Side Effects

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

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

** Hospital hyponatremia can cause irreversible brain damage and death due to the occurrence of acute hyponatremic 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 side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side 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 which is stated on the label after EXP. The expiry date is the last day of the month stated.

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 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 injectable preparations, hydrochloric acid (for pH adjustment).

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

pH: 3.5-6.5

Appearance of the Product and Contents of the Pack

Transparent solution, hypertonic, apyrogenic, and sterile.

Glucosa Physan 10% is a solution for intravenous infusion presented in 250 ml and 500 ml containers.

For single-dose containers:

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

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

In the following capacities:

• Vial and Bag of 250 ml
• Vial and Bag of 500 ml

For Clinical Containers:

With the following presentations:

1.- Glass Vials:

• 24 vials of 250 ml
• 10 vials of 250 ml
• 10 vials of 500 ml

2.- PP Vials:

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

20 vials 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 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, Nº 8 Nº 15 y Nº 16 3450-232 Mortágua – Portugal

Date of the Last Revision of this Leaflet: March 2019

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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 a 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 the water 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 10% solution for infusion can become extremely hypotonic after administration due to glucose metabolism in the body.