GENTAMICIN BRAUN 3 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Gentamicina Braun 3 mg/ml Solution for Infusion

Contents of the pack:

1. What is Gentamicina Braun 3 mg/ml and what is it used for
2. What you need to know before you use Gentamicina Braun 3 mg/ml
3. How to use Gentamicina Braun 3 mg/ml
4. Possible side effects
5. Storage of Gentamicina Braun 3 mg/ml
6. Contents of the pack and other information

1. What is Gentamicina Braun 3 mg/ml and what is it used for

Gentamicina Braun 3 mg/ml is an aqueous solution of gentamicin, a bactericidal antibiotic of the aminoglycoside group.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold.

It is essential that you follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Gentamicina Braun is used for short-term treatment, in combination with other antibiotics, for the treatment of the following diseases, except for complicated kidney, urinary tract, and bladder infections.

The main indications are as follows:

• blood infection, also known as septicemia
• infections of the skin and soft tissues (including burns)
• infections of the lower respiratory tract, which occur during hospital treatment, including severe pneumonia
• complicated and recurrent urinary tract infections
• infections of the gastrointestinal tract, including peritonitis
• infections of the heart valves (bacterial endocarditis)
• post-surgical infections

2. What you need to know before you use Gentamicina Braun 3mg/ml

Do not use Gentamicina Braun 3 mg/ml:

• If you are allergic to gentamicin or any of the other components of this medicine (see section 6), or to other aminoglycoside antibiotics.
• If you have myasthenia gravis.
• It must not be administered with other products that are toxic to the ear or kidney, or with potent diuretics.

Warnings and precautions

Consult your doctor or nurse before starting to use Gentamicina Braun 3 mg/ml.

Inform your doctor of any allergy or medical problem you have or have had, especially:

• if you are allergic to gentamicin or other aminoglycoside antibiotics.
• if your kidneys do not function properly, as this may increase the risk of toxicity
• if you have muscle disorders, such as myasthenia gravis or Parkinson's disease, as this may worsen muscle weakness.
• if you are taking diuretics that may be toxic to the ear
• if symptoms of ear toxicity such as dizziness, vertigo, tinnitus (ringing in the ears), buzzing in the ears, and hearing loss, or symptoms of kidney toxicity appear.
• if you have or have had a history of mitochondrial mutation disease (a genetic disease), or hearing loss due to antibiotic medications, you should inform your doctor or pharmacist before taking an aminoglycoside; certain mitochondrial mutations may increase the risk of hearing loss with this medicine. Your doctor may recommend a genetic test before administering Gentamicina Braun 3 mg/ml.
• if you experience severe diarrhea
• it is possible that your infection may not respond to gentamicin if you did not respond to other aminoglycosides, and you may have an allergic reaction if you are already allergic to another aminoglycoside.
• if you are pregnant or breastfeeding.

To reduce the risk of nerve damage to the ear and kidney, your doctor will be especially careful when evaluating the following:

• Monitoring of hearing, balance, and kidney function before, during, and after treatment.
• Dosage strictly according to kidney function.
• If you have altered kidney function, the total dose will be taken into account, including additional antibiotics administered directly to the site of infection.
• Monitoring of gentamicin serum concentrations during treatment if the details of your case require it.
• If you already have nerve damage in the ear (hearing loss or balance disorder), or if treatment is long-term, additional monitoring of balance and hearing function is required.
• In case of possible treatment with gentamicin, it will not exceed 10-14 days (normally 7-10 days).
• A sufficient amount of time, 7-14 days, must pass between individual treatments with gentamicin and other closely related antibiotics.
• Avoid administering other substances with potential harmful effects on the auditory nerve or kidneys in combination with gentamicin. If this is unavoidable, careful monitoring of kidney function is required.
• The level of body fluids and urine production must be within the normal range.

Other medicines and Gentamicina Braun 3 mg/ml

Tell your doctor if you are using, have recently used, or might use any other medicines.

Administration of Gentamicina Braun 3 mg/ml together with the following medicines may require modifying the dose of one of them or interrupting treatment.

Ether, muscle relaxants

The blockade of nerve and muscle function by aminoglycosides is reinforced by ether and muscle relaxants. Therefore, you will be closely monitored while receiving these substances.

Methoxyflurane anesthesia

The anesthesiologist should know if you have received or are receiving aminoglycosides before performing methoxyflurane anesthesia (an anesthetic gas) and avoid using this agent if possible, due to a higher risk of kidney damage.

Other medicines with potential harmful effects on the auditory nerve and kidneys

You will be closely monitored if you receive gentamicin before, during, or after treatment with medicines containing the following substances:

• amphotericin B (against fungal infections),
• colistin (for intestinal decontamination),
• cyclosporine (for suppressing undesirable immune reactions),
• cisplatin (anticarcinogenic agent),
• vancomycin, streptomycin, viomycin, carbenicillin, other aminoglycosides, cephalosporins (antibiotics).

You will also be closely monitored if you receive medicines to increase urine flow that contain, for example, ethacrynic acid and furosemide.

Gentamicin may produce alterations in the values of some substances in analyses, such as urea, transaminases, alkaline phosphatase, bilirubin, creatinine, lactate dehydrogenase, sodium, potassium, magnesium, and calcium.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Treatment during pregnancy is not recommended, although your doctor will assess the convenience of its use. If the medicine is used during pregnancy, or if you become pregnant during treatment, you must be informed of the possible risks.

As a general rule, breastfeeding should not be done if the mother is under treatment. Your doctor will assess the convenience of its use in each case.

Driving and using machines:

The use of this medicine may affect your ability to drive vehicles or use machinery, even after treatment, especially if you have received prolonged treatments or high doses, in cases of uncontrolled kidney failure, or in advanced age. Therefore, you should exercise extreme caution when driving vehicles or using machinery.

Gentamicina Braun 3 mg/ml contains sodium:

Bottles of 80 ml:

This medicine contains 283.47 mg of sodium (main component of table salt/cooking salt) in each 80 ml bottle. This is equivalent to 14.17% of the maximum recommended daily sodium intake for an adult.

Bottles of 100 ml:

This medicine contains 354.33 mg of sodium (main component of table salt/cooking salt) in each 100 ml bottle. This is equivalent to 17.72% of the maximum recommended daily sodium intake for an adult.

3. How to use Gentamicina Braun 3 mg/ml

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or nurse. In case of doubt, ask your doctor or nurse.

Your doctor will indicate the duration of your treatment. Do not stop treatment before completion.

Gentamicina Braun 3 mg/ml will be administered by healthcare personnel only by intravenous infusion over 30-60 minutes.

Your doctor will determine the most suitable dose for you, according to your age, weight, general condition, severity of the infection, and kidney function. Kidney function should be monitored during treatment.

Adults and Adolescents (12 to 17 years old)

As a general rule, the recommended dose in adults and adolescents with normal kidney function is 3-6 mg/kg/day of gentamicin base in the form of a single daily dose or divided into two daily infusions.

Generally, treatment with gentamicin will not last more than 7-10 days, only in cases of severe and complicated infections may treatment exceed 10 days.

Gentamicin levels in the blood will be carefully monitored by examining blood samples taken at the end of a dosing interval and immediately after the end of the infusion, mainly to monitor kidney function. Your dose will be carefully adjusted to avoid kidney damage.

Use in children

The daily dose in newborns is 4 to 7 mg/kg of body weight per day. Newborns receive the required daily dose in a single dose.

The daily dose in infants after the first month of life is 4.5-7.5 mg/kg of body weight per day as 1 (preferably) to 2 single doses.

The recommended daily dose in older children with normal kidney function is 3-6 mg/kg of body weight per day as 1 (preferably) to 2 single doses.

Dosage in patients with impaired kidney function

If you have kidney function impairment, you will be monitored to adjust gentamicin concentrations in the blood properly, either by reducing the dose or prolonging the time between individual doses. Your doctor knows how to adjust the dosing schedule in such cases.

Dosage in patients undergoing renal dialysis

In this case, your dose will be carefully adjusted according to gentamicin levels in the blood.

In patients with impaired liver function, it is not necessary to adjust the dose

Use in elderly patients:

Elderly patients may require lower maintenance doses than younger adults to achieve sufficient gentamicin levels in the blood.

Dosage in patients with obesity

The initial dose should be based on the ideal body weight plus 40% of excess weight.

If you use more Gentamicina Braun 3 mg/ml than you should:

In case of overdose or accidental ingestion, consult the Toxicology Information Service (telephone: 91 562 04 20) or consult your doctor or pharmacist. Bring this leaflet with you.

In case of a toxic reaction due to high dosing or accumulation, especially in patients with severe kidney failure, peritoneal dialysis or hemodialysis may facilitate the elimination of the antibiotic.

If a hypersensitivity reaction occurs, its administration will be discontinued, and the patient will receive specific treatment according to the nature and intensity of the reaction (antihistamines, corticosteroids, adrenaline...)

If you have any other questions about the use of this product, ask your doctor or pharmacist.

If you forget to use Gentamicina Braun 3 mg/ml:

Do not take a double dose to make up for forgotten doses.

If you stop treatment with Gentamicina Braun 3 mg/ml

If you have any other questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following is a list of adverse reactions by system organ class and frequency, according to the following criteria:

Very common (1 in 10 patients), common (1 in 100 patients), uncommon (1 in 1,000 patients), rare (1 in 10,000 patients), and very rare (less than 1 in 100,000 patients)

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gentamicina Braun 3 mg/ml.

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use Gentamicina Braun 3 mg/ml after the expiration date stated on the packaging. The expiration date is the last day of the indicated month.

The contents of the vials should be used immediately after opening. Once the package is opened, discard the unused portion of the solution.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of packaging and medicines that are no longer needed. This will help protect the environment.

6. Package contents and additional information

Composition ofGentamicina Braun 3 mg/ml

The active ingredient of Gentamicina Braun 3 mg/ml is Gentamicina sulfate

Each vial contains 3 mg/ml of gentamicina base.

The active ingredient is gentamicina (in the form of sulfate).

Each ml of solution contains gentamicina (as sulfate) equivalent to 3 mg of gentamicina.

Each 80 ml vial contains 240 mg of gentamicina

Each 100 ml vial contains 300 mg of gentamicina

The other components are: sodium chloride, sodium edetate, and water for injectables in sufficient quantity.

Appearance of the product and package contents

It is presented in packages of 1 and 20 vials of polyethylene containing 80 ml and 100 ml of solution.

Marketing authorization holder and manufacturer

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

This leaflet was approved in October 2024.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

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This information is intended solely for doctors or healthcare professionals:

Renal and auditory nerve functions should be carefully monitored in patients with renal insufficiency when used for long periods or when administered in doses higher than recommended. The appearance of signs of nephro or ototoxicity will determine a readjustment of the dosage or suspension of treatment according to the cases.

Patients should be well hydrated during treatment.

Gentamicina Braun 3 mg/ml solution for intravenous perfusion is a ready-to-use solution and therefore should not be diluted before administration. However, it can be perfused simultaneously in the same intravenous line with 0.9% sodium chloride or 5% glucose solutions.

Aminoglycosides should not be mixed with any other medicine, but should be administered separately.

Handle under usual asepsis conditions for the use of solutions for intravenous perfusion.

Once the package is opened, discard the unused portion of the solution.

Due to the potential toxicity of aminoglycosides, "fixed dose" recommendations that are not based on body weight should not be followed. However, it is essential to calculate the dosage to establish the needs of each patient.

MEDICINE SUBJECT TO MEDICAL PRESCRIPTION

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