Freeflex glucose 5% solution for infusion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Freeflex Glucose 5% solution for infusion

Glucose

Package leaflet contents:

1. What Freeflex Glucose 5% is and what it is used for
2. Before you use Freeflex Glucose 5%
3. How to use Freeflex Glucose 5%
4. Possible side effects
5. How to store Freeflex Glucose 5%
6. Further information

1. What FREEFLEX GLUCOSE 5% is and what it is used for

Freeflex Glucose 5% is an intravenous infusion solution supplied in bags of 100 ml containing 50 ml or 100 ml of solution, as well as bags of 250 ml, 500 ml, and 1000 ml.

It 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 supply in parenteral nutrition when oral intake of food is limited, in carbohydrate metabolism disorders (hypoglycemia, insulin coma, hepatic coma, ketotic vomiting), and as a vehicle for the administration of compatible medications.

2. BEFORE USING FREEFLEX GLUCOSE 5%

Do not use Freeflex Glucose 5%

• if you are allergic (hypersensitive) to the active substance or to any of the other components of Freeflex Glucose 5%
• 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 or elevated blood glucose levels
• in conditions of hyperhydration (fluid overload)
• in cases of generalized edema (accumulation of fluid in body tissues)
• if you have hyperlactacidemia (presence of lactic acid in blood)
• if you suffer from significant disturbances in glucose tolerance, including hyperosmolar coma.

Warnings and precautions

Exercise special caution with Freeflex Glucose 5%

• Blood glucose concentration must 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 and acid-base imbalances. In patients with sodium deficiency, administration of sodium-free solutions may lead to peripheral circulatory collapse and oliguria (scant urine output).

• Regular blood tests for glucose, electrolytes, fluid balance, and acid-base equilibrium are recommended, since frequent and massive intravenous (parenteral) administration of glucose solutions may cause fluid overload (hyperhydration) and significant ionic depletions. In such cases, electrolyte supplementation may be necessary.

• Potassium may be administered along with glucose solution to prevent hypokalemia (low potassium levels in blood) caused by prolonged parenteral feeding with glucose.

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

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

• Blood must not be administered simultaneously using the same administration set as this medicine.

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

• Special attention will be given if you are elderly, as hepatic and/or renal functions may be impaired.

• Do not administer by intramuscular route.

  • If you are experiencing critical conditions, pain, postoperative stress, infections, burns, or central nervous system diseases

• You have any type of heart, liver, or kidney disease and are being treated with a medication that enhances the effect of vasopressin (a hormone regulating water retention in the body), as this may increase the risk of developing hospital-acquired low blood sodium levels (hyponatremia). (See section "Other medicines and Freeflex Glucose 5%")

All patients must be closely monitored. In cases where normal regulation of blood water content is disrupted due to increased secretion of vasopressin, also known as Antidiuretic Hormone (ADH), infusion of fluids with low sodium chloride concentration (hypotonic fluids) may result in low sodium levels in blood (hyponatremia). This can cause headache, nausea, seizures, lethargy, coma, brain swelling (cerebral edema), and death; therefore, these symptoms (acute symptomatic hyponatremic encephalopathy) are considered a medical emergency. (See section 4. Possible side effects)

Children, women of childbearing age, and patients with brain disorders such as meningitis, cerebral hemorrhage, cerebral contusion, and cerebral edema are at special risk of developing severe and potentially fatal brain swelling caused by acute hyponatremia.

Other medicines and Freeflex Glucose 5%

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, as it may be necessary to discontinue or adjust the dose of one or more of them.

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

• Insulin or oral antidiabetics (biguanides, sulfonylureas): these medicines reduce the effect of glucose

• Corticosteroids: due to the risk of increased blood glucose or because these medicines may retain sodium and water

• Digitalis glycosides (digoxin): if intravenous glucose administration coincides with treatment with digitalis glycosides (digoxin), there is a risk of developing toxicity from these medicines.

• Medicines that increase the effect of vasopressin (see section "Warnings and precautions"), for example:

  • Medicines that stimulate vasopressin release (e.g., antipsychotics, narcotics)
  • Medicines that enhance the action of vasopressin (e.g., non-steroidal anti-inflammatory drugs)
  • Medicines that act like vasopressin, known as vasopressin analogues

• Other medicines that increase the risk of hyponatremia, including diuretics in general and antiepileptics.

In any case, the doctor must verify the compatibility of any added medicines.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

This medicine should be administered with special caution in pregnant women during labor, especially if administered in combination with oxytocin (a hormone that may be given to induce labor and control bleeding), due to the risk of hyponatremia. During pregnancy, your doctor will decide whether 5% glucose solution is appropriate, as it should be used cautiously in this case. Intravenous glucose administration during pregnancy may elevate glucose and insulin levels, as well as acidic components, in fetal blood.

There is no evidence suggesting that 5% Glucose may cause adverse effects during breastfeeding in the neonate. Nevertheless, caution is recommended during this period.

Driving and use of machines

Not applicable, due to the characteristics of its use.

3. HOW TO USE FREEFLEX GLUCOSE 5%

Follow exactly the administration instructions for Freeflex Glucose 5% as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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.

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.

If you use more Freeflex Glucose 5% than you should

In case of overdose, hyperglycemia, glucosuria (presence of glucose in urine), hyperhydration, or electrolyte disturbances may occur. Administration should be discontinued and symptomatic treatment initiated.

If you are not hospitalized, go to the nearest hospital or contact the Toxicology Information Service. Telephone: 91 562 04 20.

4. Possible adverse effects

Like all medicines, Freeflex Glucose 5% may produce adverse effects, although not everyone will experience them.

Hyperglycemia, glycosuria (glucose in urine), or disturbances in fluid or electrolyte balance may occur if the solution 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.

Headache, nausea, seizures, lethargy. These may be caused by low sodium levels in the blood. When sodium levels in the blood drop significantly, water enters the brain cells causing them to swell. This results in increased intracranial pressure and leads to hyponatremic encephalopathy.

Whenever any of these adverse reactions occur, inform your doctor, who will assess whether it is necessary to discontinue treatment.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of FREEFLEX GLUCOSE 5%

No special storage conditions are required.

Keep out of the reach and sight of children.

Do not use Freeflex Glucose 5% after the expiry date stated on the container.

Do not use Freeflex Glucose 5% if the solution is not clear or contains precipitates.

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. ADDITIONAL INFORMATION

Composition of Freeflex Glucose 5%

The active substance is glucose. Each 100 ml of solution contains 5 g of glucose (as monohydrate, 5.5 g).

The other components are: water for injectable preparations, hydrochloric acid for pH adjustment.

Isotonic, sterile, pyrogen-free solution.

Theoretical osmolarity: 278 mosm/L

pH: 3.5–6.5

Theoretical caloric content: 200 kcal/L

Appearance of the product and contents of the pack

Freeflex Glucose 5% is a clear, colourless solution, free from visible particles. It is supplied in bags of 100 ml containing 50 ml or 100 ml of solution, and in bags of 250 ml, 500 ml and 1000 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Fresenius Kabi España S.A.U
C/ Marina 16-18
08005-Barcelona (Spain)

Manufacturer:

Fresenius Kabi France, S.A.
6, Rue du Rempart, B.P. 611
(Louviers) F-27400 France

Fresenius Kabi Deutschland, GmbH
Freseniusstraße 1
61169 Friedberg
Germany

HP Halden Pharma AS
Svinesundsveien 80
1788 Halden
Norway

This leaflet was last reviewed in February 2022

This information is intended for healthcare professionals only:

This medicinal product 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 this is not the case.

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

Use aseptic techniques when administering the solution and when preparing mixtures.

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

General advice

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 with products having a lower sodium concentration compared to serum sodium levels. Following infusion of Freeflex Glucose 5%, rapid and active transport of glucose into body cells occurs. This condition promotes an effect equivalent to the administration of free water and may lead to severe hyponatremia.