Glucosum Teva

Package Leaflet: Information for the User

GLUCOSUM TEVA

200 mg/ml solution for injection
400 mg/ml solution for injection
Glucosum

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Glucosum Teva and what is it used for
• 2. Important information before using Glucosum Teva
• 3. How to use Glucosum Teva
• 4. Possible side effects
• 5. How to store Glucosum Teva
• 6. Contents of the pack and other information

1. What is Glucosum Teva and what is it used for

Glucose is a simple sugar, a natural source of energy for the body, used mainly by nerve cells, heart muscle, striated muscles, and liver. 1 gram of glucose provides 4 kcal of energy.
Solutions of glucose from 10% to 40% are hypertonic fluids in relation to blood.
100 ml of 20% glucose solution provides 80 kcal.
100 ml of 40% glucose solution provides 160 kcal.
40% solutions, through their osmotic action, reduce intracranial pressure. They also have an alkalizing and diuretic effect.
Indications for the use of Glucosum Teva:

• hypoglycemia (too low blood glucose level)
• carbohydrate deficiency and energy deficiencies
• parenteral nutrition
• hyperosmolar and isoosmolar dehydration
• symptomatic treatment of conditions with increased intracranial pressure.

2. Important information before using Glucosum Teva

When not to use Glucosum Teva:

• diabetes
• hyperglycemic coma
• anuria
• bleeding into the central nervous system
• intolerance to glucose and galactose
• hypotonic dehydration
• overhydration
• delirium tremensin dehydrated patients
• states after acute cerebral hypoxia
• hypokalemia
• allergy to cereals or cereal products.

Warnings and precautions

Before starting treatment with Glucosum Teva, discuss it with your doctor or pharmacist.
During long-term use of glucose infusions, it is necessary to monitor the electrolyte composition of the blood, the degree of hydration of the body, and periodically - the glucose level in the blood. Glucose solutions with concentrations above 15% should be administered into central vessels, except in life-threatening conditions (severe hypoglycemia - significant drop in blood sugar level). In the case of hypoglycemia and the need to administer a high-concentration solution into a peripheral vein, slow administration is recommended. After sudden discontinuation of hypertonic glucose infusion, a secondary drop in blood glucose level may occur.
Cautions should also be exercised during infusions of concentrated glucose solutions to patients with sepsis, severe injuries, significant malnutrition, vitamin B deficiency, hypophosphatemia, and hemodilution (blood dilution).

Using Glucosum Teva in patients with kidney and/or liver impairment

There are no data indicating the need to adjust the dosage in patients with impaired kidney and/or liver function.

Glucosum Teva and other medicines

Glucose solutions should not be mixed with aminophylline, barbiturates, erythromycin, hydrocortisone, warfarin, kanamycin, sulfonamides, vitamin B, and phenytoin.
Glucose solution should not be administered using the same infusion set before, during, and after blood transfusion.
Cautions should be exercised in patients taking digitalis preparations, as concentrated glucose solutions may enhance their effect.

Pregnancy and breastfeeding

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.
No adequate studies have been conducted in pregnant or breastfeeding women.
The use of the medicine during pregnancy and breastfeeding is decided by the doctor.

Driving and using machines

Glucose does not affect psychophysical fitness and does not affect the ability to drive vehicles or operate machines.

3. How to use Glucosum Teva

This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
20% and 40% glucose solutions are administered intravenously, by injection or by drip infusion, in doses selected individually depending on the patient's health, age, and body weight.
It is recommended to carefully monitor the glucose and electrolyte levels in the blood, especially during long-term parenteral nutrition.
Adults:

• in malnourished and undernourished patients, up to 300 g of glucose can be administered as a slow infusion. When using concentrated glucose solutions, there is a need to administer insulin in a dose of 1 unit of insulin per approximately 4 g of glucose.
• in parenteral nutrition: the required dose is usually 1.5 g - 3.0 g of glucose/kg body weight per day, the recommended dose is 3 g of glucose/kg body weight per day, administered as a slow infusion into a central vein.
• in hypoglycemia: 20% or 40% glucose solution (0.2 g/kg body weight) should be administered intravenously until a normal blood glucose level is achieved.

Use in children:

• in hypoglycemia: 0.5 g of glucose/kg body weight is administered.
• during resuscitation procedures: from 0.5 g to 1 g of glucose/kg body weight, intravenously. If you feel that the effect of the medicine is too strong or too weak, you should consult a doctor.

Using a higher dose of Glucosum Teva than recommended

In case of glucose overdose, insulin should be administered, electrolyte disturbances should be corrected (biochemical parameters should be monitored), and symptomatic treatment should be carried out.
Glucose overdose may lead to hyperglycemia (too high blood glucose level), glucosuria (presence of glucose in urine), dehydration, which may result in hyperosmolar coma and even death.
In case of overdose, you should immediately inform your doctor, who will provide appropriate treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are listed below by system organ class and frequency (if known).
Frequency of occurrence: Very common: (≥1/10), Common: (≥1/100, <1>
(≥1/1000, <1>
Metabolic and nutritional disorders
Frequency unknown: electrolyte disturbances (including hypokalemia, hypomagnesemia, hypophosphatemia, hyponatremia), metabolic disorders (hyperglycemia, hyperglycemic coma, hyperosmolar, glucosuria, and hypoglycemia - due to hyperinsulinemia, following sudden discontinuation of concentrated glucose solution).
General disorders and administration site conditions
Frequency unknown: pain at the injection site, vein irritation
Single cases: feeling of heat (especially with too rapid administration)
Immune system disorders
Single cases: anaphylactoid reactions (in patients with asthma and diabetes)
Hypertonic glucose solutions may cause osmotic diuresis and dehydration of the body.
Concentrated glucose solutions (above 15%) damage the vascular endothelium, causing local thrombophlebitic changes in peripheral veins.
To prevent metabolic complications, it is necessary to monitor blood glucose levels and, if necessary, administer appropriate doses of exogenous insulin (without insulin, the body is able to metabolize glucose at a rate of approximately 0.25 g/kg body weight per hour).
Too rapid administration of glucose may cause circulatory failure, pulmonary edema, and peripheral edema.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Glucosum Teva

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging after: EXP. The expiry date refers to the last day of the month stated.
Once opened, the packaging should not be stored and used again.
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 other information

What Glucosum Teva 200 mg/ml solution for injection contains

• The active substance is glucose. 1 ml of solution contains 200 mg of glucose. Each ampoule (10 ml) contains 2.0 g of glucose.
• The other ingredients are water for injections.

What Glucosum Teva 400 mg/ml solution for injection contains

• The active substance is glucose. 1 ml of solution contains 400 mg of glucose. Each ampoule (10 ml) contains 4.0 g of glucose.
• The other ingredients are water for injections.

What Glucosum Teva looks like and contents of the pack

Clear, colorless solution.
Ampoules made of colorless glass with a capacity of 10 ml.
10 or 50 ampoules in a cardboard box or a collective packaging of 50 ampoules (5 packs of 10 ampoules).
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00

Manufacturer:

Merckle GmbH
Ludwig-Merckle Str. 3
89143 Blaubeuren, Germany

Date of last revision of the leaflet: March 2022