Glucose Physan 5% solution for infusion

Package leaflet: Information for the user

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 questions, ask your doctor, pharmacist, or nurse. If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Glucosa Physan 5% 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 5%

Do not use Glucosa Physan 5%:

• If you are allergic to anhydrous glucose or to 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 after a head injury.

• In cases 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 5%.

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

• In patients who have suffered acute ischemic events (reduced or absent arterial circulation), 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-volume administration of parenteral glucose solutions may cause fluid overload (hyperhydration) and significant ionic depletions. In such cases, electrolyte supplementation may be necessary.

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

• If you suffer from malnutrition, you may have a deficiency of vitamin B1 (thiamine). This vitamin is essential for glucose metabolism; therefore, if needed, this deficiency should be corrected first.

• 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 monitored regularly in diabetic patients, and insulin requirements adjusted accordingly.

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

• Continuous administration at the same infusion site may lead to thrombophlebitis (vein inflammation).

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

• Do not administer by intramuscular route.

Glucose solutions for intravenous infusion are generally isotonic. However, in the body, glucose solutions may become physiologically highly 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 administration of glucose may cause electrolyte disturbances, the most important being hyperosmolar hyponatremia.

Hyponatremia:

Patients with non-osmotic release of vasopressin (e.g., in critical illness, pain, postoperative stress, infections, burns, and CNS disorders), patients with heart, liver, or kidney disease, and patients exposed to vasopressin agonists are at particular 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 reproductive age, and patients with reduced cerebral compliance (e.g., meningitis, intracranial hemorrhage, cerebral contusion) are at particular risk of severe and potentially fatal cerebral edema caused by acute hyponatremia.

Use of Glucosa Physan 5% with other medicines

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

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 having glucocorticoid activity (e.g., 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 administered with caution due to their capacity to retain water and sodium.

• Digitalis glycosides (digoxin): If intravenous glucose administration coincides with treatment 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 when inadequately balanced intravenous perfusion solutions are used:

• 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 potentiate 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 lactation and fertility

Glucose Physan 5% must be administered with special caution in pregnant women during labor, especially if given 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 this medicine.

During pregnancy, your doctor will decide whether the use of 5% glucose solution is appropriate, as it should be used with caution in such cases. Intravenous administration of glucose during pregnancy may increase glucose and insulin levels, as well as acidic components in the fetal blood.

There is no evidence suggesting that 5% glucose may cause adverse effects during lactation in the neonate. Nevertheless, caution is recommended when using it during this period.

Driving and use of machines:

Not applicable.

3. How to use Glucosa Physan 5%

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 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 body 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/24h for weight above 10 kg.
Over 20 kg: 1500 ml + 20 ml/kg/24h for weight above 20 kg.

(See also section 6).

If you have been given more Glucosa Physan 5% 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, you should inform your doctor, who will assess whether it is necessary or not to discontinue 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 you observe these adverse effects or any others not described in this leaflet, 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 may 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 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 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 containers you no longer need. This will help protect the environment.

6. Contents of the container and other 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 components (excipients) are: water for injections, hydrochloric acid (for pH adjustment).

Theoretical osmolarity: 278 mosm/l.

Theoretical calories: 200 kcal/l.

pH: 3.5–6.5.

Appearance of the product and contents of the container

Clear, isotonic, non-pyrogenic, sterile solution.

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

For single-dose containers:

Available in bottles made of Type II glass and polypropylene (PP), as well as in bags made of polypropylene (PP) and polyvinyl chloride (PVC).

Available in the following sizes:

• Bottle and Bag of 100 ml containing 50 ml or 100 ml of solution.
• Bottle and Bag of 250 ml
• Bottle and Bag of 500 ml
• Bottle and Bag of 1000 ml.

For Clinical Packs:

Available in the following presentations:

1.- Glass Bottles:

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

2.- PP Bottles:

• 30 bottles of 100 ml containing 50 ml or 100 ml of solution.
• 50 bottles of 100 ml containing 50 ml or 100 ml of solution.
• 20 bottles of 250 ml
• 24 bottles of 250 ml
• 10 bottles of 500 ml
• 20 bottles of 500 ml
• 10 bottles 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 most recent revision of this package leaflet: March 2019

This information is intended for healthcare professionals only:

This medicine must always be administered by trained 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 otherwise. The contents of each bottle, vial, or bag 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 administering it concomitantly with other drugs, compatibility must be verified.

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 5% infusion solution may become extremely hypotonic after administration due to the metabolism of glucose in the body.