Glucose 5% Mein solution for infusion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Glucosa 5% Mein solution for infusion

Glucose

Package leaflet contents:

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

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

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

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 source in parenteral nutrition when oral intake 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 GLUCOSE 5% MEIN

Do not use Glucose 5% Mein

• if you are allergic (hypersensitive) to the active substance or to any of the other components of Glucose 5% Mein
• if you have been diagnosed with hypotonic dehydration, salt loss, or decreased urine volume.
• during the first 24 hours after head trauma.
• in cases of hyperglycemia or elevated blood glucose levels.
• in states of hyperhydration (fluid overload)
• in conditions of generalized edema (accumulation of fluid in body tissues)
• if you have hyperlactacidemia (presence of lactic acid in the blood)
• if you suffer from significant disturbances in glucose tolerance, including hyperosmolar coma.

Warnings and precautions

Exercise special caution with Glucose 5% Mein

• 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 disturbances in acid-base balance. In patients with sodium deficiency, administration of sodium-free solutions may cause peripheral circulatory collapse and oliguria (scant urine secretion).

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

• Alongside glucose solution, potassium may be administered 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 already been initiated. Blood glucose levels should 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 infusion site may lead to thrombophlebitis (vein inflammation).

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

• Do not administer by intramuscular route.

• If you suffer from critical conditions, pain, postoperative stress, infections, burns, or diseases of the central nervous system

• If 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), because this may increase the risk of developing low blood sodium levels (hyponatremia) in hospital settings. (See section Other medicines and Glucose 5% Mein)

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 blood sodium levels (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 Glucose 5% Mein

Inform your doctor or pharmacist if you are taking, have recently taken, or might take 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 levels or because these medicines can 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 potentiate 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 physician must verify the compatibility of added medications.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

This medicine should be administered with special caution in pregnant women during childbirth, 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 the use of 5% glucose solution is appropriate, as it should be used cautiously in this case. Intravenous administration of glucose 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 in the neonate during breastfeeding. Nevertheless, caution is recommended during this period.

Driving and using machines

Not applicable, due to the characteristics of its use.

3. HOW TO USE GLUCOSE 5% MEIN

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

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 Glucose 5% Mein 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, Glucosa 5% Mein 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 levels of sodium 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 additional 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 GLUCOSE 5% MEIN

No special storage conditions are required.

Keep out of the reach and sight of children.

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Glucose 5% Mein

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 injections, hydrochloric acid for pH adjustment.

Isotonic, apyrogenic and sterile solution.

Theoretical osmolarity: 278 mosm/l
pH: 3.5–6.5
Theoretical calories: 200 kcal/l

Appearance of the product and contents of the container

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

Marketing Authorization Holder

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

Manufacturer

Fresenius Kabi Italia S.R.L.
Via Camagre, 41/43
37063 Isola della Scala - Verona
(Italy)

This leaflet has been last reviewed in

August 2018

This information is intended for healthcare professionals only:

This medicine must always be administered by trained personnel. It is administered by intravenous infusion via 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 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 concomitantly with other drugs, compatibility must be verified to ensure no incompatibilities exist.

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. After infusion of Glucose 5% Mein, 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.