User Information: Package Insert

GLUCOSA TRAVEL PHARMA 50% Solution for Infusion

Read this package insert carefully before starting to use the medication.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor.

GLUCOSA TRAVEL PHARMA 50% solution for perfusion belongs to the group of solutions for parenteral nutrition intended for the provision of water and energy.

It is indicated for the treatment of hypertonic dehydration (vomiting, diarrhea, profuse sweating), in carbohydrate metabolism alterations (hypoglycemia, insulin coma, acetone vomiting).

Do not use GLUCOSA TRAVEL PHARMA 50% solution for perfusion

• If you are allergic (hypersensitive) to the active ingredient or any of the other components of GLUCOSA TRAVEL PHARMA 50% solution for perfusion
• If you have been diagnosed with hypotonic dehydration, loss of electrolytes, or decreased urine volume
• Within the first 24 hours after a head trauma
• In states of hyperglycemia
• In states of hyperhydration, generalized edema
• If you have hyperlactacidemia
• If you have significant alterations in glucose tolerance, including hyperosmolar coma

Be especially careful with GLUCOSA TRAVEL PHARMA 50% solution for perfusion

• Blood glucose levels must be closely monitored in cases of intracranial hypertension

• If you have suffered acute ischemic attacks (decreased or absent circulation in arteries), as hyperglycemia has been related to an increase in ischemic cerebral damage and difficulty in recovery
• In cases of shock and acid-base balance alterations, patients should be treated by administering electrolytes before administering glucose solutions. In patients with sodium deficiency, administering solutions without sodium may cause peripheral circulatory collapse and oliguria (scanty urine secretion)
• Regularly monitor glucose, serum electrolytes, water balance, and acid-base balance, as frequent and massive administration of parenteral glucose solutions can cause fluid overload (hyperhydration) and significant ionic depletions. In this case, electrolyte supplements will be necessary
• To avoid hypopotasemia produced during prolonged parenteral glucose feedings, potassium may be added to the glucose solution as a safety measure
• If you are malnourished, you may have a deficiency of vitamin B1. This vitamin is essential for glucose metabolism, so this deficiency must be corrected first if necessary
• If you have diabetes. In this case, glucose solutions may be used as long as initial appropriate treatment (insulin) has been established. Glucose levels must 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
• When administered continuously in the same infusion site, it may cause thrombophlebitis (inflammation of the veins)
• Special attention should be paid if used in elderly patients, as they may have impaired liver and/or renal function
• Do not administer by intramuscular route

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription

It is essential to inform your doctor if you are using any of the following medications:

• Insulin or oral antidiabetic agents (biguanides, sulfonylureas): Intravenous administration of glucose in patients treated with insulin or oral antidiabetic agents may decrease their effectiveness (antagonistic action)
• Corticosteroids: Intravenous administration of glucose solutions in patients treated with systemic corticosteroids with glucocorticoid activity (cortisol) may lead to a significant increase in plasma glucose levels, due to the hypoglycemic action of these substances. In the case of 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 may occur, with the risk of developing intoxication by these medications. This is due to the hypopotasemia that may be caused by glucose administration, unless potassium is added to the solution

In any case, the doctor must check the compatibility of the added medications

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication

In the case of pregnancy, your doctor will decide whether to use 50% glucose solution, as it should be used with caution in this case. Administration of glucose by intravenous route during pregnancy may elevate glucose and insulin levels as well as acidic components in the fetus's blood

There is no evidence to suggest that 50% glucose may cause adverse effects during the lactation period in the neonate. However, it is recommended to use with caution during this period

Driving and operating machinery

It is not advisable, due to its characteristics of use

Follow exactly the administration instructions for GLUCOSA TRAVEL PHARMA 50% solution for perfusion as indicated by your doctor. Consult your doctor if you have any doubts.

The normal dose is administered intravenously drop by drop according to your age, body weight, clinical condition, and metabolic state.

According to individual needs, 1.5-3.0 g of glucose per kilogram of body weight per day; or up to 0.5 g of glucose per kg of body weight per hour; recommended perfusion rate 40-60 drops/minute.

If you use more GLUCOSA TRAVEL PHARMA 50% solution for perfusion than you should:

In case of overdosing, hyperglycemia, glucosuria, hyperhydration, or electrolyte disorders may appear. Administration will be suspended and symptomatic treatment will be sought.

If you are not admitted to a hospital, go to the nearest hospital or contact the Toxicological Information Service. Phone: 91 562 04 20.

Like all medications, GLUCOSA TRAVEL PHARMA 50% solution for infusion, may have adverse effects, although not all people may experience them.

Hypoglycemia, glucosuria (glucose in urine) or alterations 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, hyperglycemia resulting from rapid infusion or excessive fluid volume should be monitored in severe cases of diabetes mellitus, and can be prevented by reducing the dose and infusion rate or administering insulin.

A local reaction may occur at the site of injection.

Whenever any of these adverse reactions occur, you should inform your doctor, who will evaluate the need to discontinue the medication.

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

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use GLUCOSA TRAVEL PHARMA 50% solution for perfusion after the expiration date that appears on the label. The expiration date is the last day of the month indicated.

No special storage conditions are required.

The solution must be transparent and not contain precipitates. Do not use otherwise. The contents of each vial are for a single perfusion, discard any unused portion.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will help protect the environment.

Composition of GLUCOSA TRAVEL PHARMA 50% solution for infusion

The active ingredient is glucose.

The other components are injection water.

Appearance of the product and contents of the package

GLUCOSA TRAVEL PHARMA 50% solution for infusion is an injectable solution, colorless and transparent.

GLUCOSA TRAVEL PHARMA 50% solution for infusion is an intravenous infusion solution that is available in 500 ml and 1000 ml containers.

It is also available in a clinical container for all presentations:

• 10 containers of 500 ml.
• 10 containers of 1000 ml.

Holder of the marketing authorization and responsible for manufacturing

TRAVEL PHARMA COMPANY 28, S.L.

C/Marcelino González, nº 12 – basement

Gijón (Asturias)

This information is intended solely for medical professionals or healthcare professionals

Administration method

This medication will be administered only by specialized personnel. It will be administered by infusion, through a central or peripheral vein.

Precautions for use

Use an aseptic method to administer the solution and in case of preparing mixtures.

Before adding medications to the solution or administering simultaneously with other medications, check for any incompatibilities.

This prospectus was approved in March 2009