Label: information for the user

Gentamicin Braun 3 mg/ml infusion solution

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

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
• Soft tissue and skin infections (including burns)
• Lower respiratory tract infections, which occur during hospital treatment, including severe pneumonia
• Complicated and recurrent urinary tract infections
• Gastrointestinal tract infections, including peritonitis
• Heart valve infections (bacterial endocarditis)
• Surgical site infections

No use Gentamicina Braun 3 mg/ml:

• If you are allergic to gentamicin or any of the other components of this medication (see section 6), or to other aminoglycoside antibiotics.
• If you havemyasthenia gravis.
• Do not administer with other products that are toxic to the ear or kidney, or with powerful diuretics.

Advertencias 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 it may increase the risk of toxicity.
• If you have muscle disorders, such asmyasthenia gravisor Parkinson, as it 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 kidney toxicity symptoms appear.
• If you have, or have had a maternal history of mitochondrial disease (a genetic disease), or hearing loss due to antibiotic medications, it is recommended that you inform your doctor or pharmacist before taking an aminoglycoside; certain mitochondrial mutations may increase the risk of hearing loss with this medication. Your doctor may recommend a genetic test before administering Gentamicina Braun 3 mg/ml.
• If intense diarrhea appears.
• Your infection may not respond to gentamicin if it 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 ear and kidney nerve damage, your doctor will be especially careful to evaluate the following:

• Auditory, balance, and renal function monitoring before, during, and after treatment.
• Strict dosing according to renal function.
• If you have impaired renal function, the total dose will be taken into account for additional antibiotics administered directly at the site of infection.
• Monitoring of serum gentamicin concentrations during treatment if your case requires it.
• If you already have ear nerve damage (auditory function deterioration or balance disorder), or if treatment is prolonged, additional monitoring of balance and auditory function is required.
• Treatment with gentamicin should not exceed 10-14days (usually 7-10days).
• Sufficient time, 7-14days, should elapse between individual treatments with gentamicin and other closely related antibiotics.
• Avoid administering other substances that may be damaging to the auditory nerve or kidneys in combination with gentamicin. If this is unavoidable, close monitoring of renal function is required.
• The level of body fluids and urine production should be within the normal range.

Other medications and Gentamicina Braun 3 mg/ml

Inform your doctor if you are using, have used recently, or may need to use any other medication.

The administration ofGentamicina Braun 3 mg/mlwith the following medications may require modifying the dose of one or the other or interrupting treatment.

Ether, muscle relaxants

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

Anesthesia with methoxyflurane

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

Other medications with possible damaging effects on the auditory nerve and kidneys

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

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

You will also be closely monitored if you receive diuretics that contain, for example, etacrynic acid and furosemide.

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

Pregnancy and lactation:

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

It is not recommended to treat during pregnancy, although your doctor will evaluate the convenience of its use. If the medication is used during pregnancy, or if the patient becomes pregnant during treatment, she should be informed of the possible risks.

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

Driving and operating machinery:

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

Gentamicina Braun 3 mg/ml contains sodium:

80 ml bottles:

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

100 ml bottles:

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or nurse. If in doubt, ask your doctor or nurse.

Your doctor will inform you of the duration of your treatment. Do not discontinue treatment before.

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

Your doctor will determine the most suitable dose for you, based on your age, weight, general condition, severity of the infection, and kidney function. Renal function monitoring should be performed during treatment.

Adults and Adolescents (12 to 17 years)

As a general rule, the recommended dose in adults and adolescents with normal renal 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, gentamicin treatment will not last more than 7-10 days, except in cases of

severe and complicated infections, treatment may exceed 10 days.

Blood gentamicin levels 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 renal function. Your dose will be carefully adjusted to avoid renal 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 renal function is 3-6 mg/kg of body weight per day as 1 (preferably) to 2 single doses.

Dosing in patients with renal impairment

If you have renal impairment, you will be monitored to adjust the gentamicin blood concentrations appropriately, either by reducing the dose or prolonging the time between

doses. Your doctor knows how to adjust the dosing schedule in this case.

Dosing in patients undergoing renal dialysis

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

In patients with impaired liver function, no dose adjustment is necessary

Use in elderly patients:

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

Dosing in obese patients

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

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service (phone: 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 renal insufficiency, peritoneal dialysis or hemodialysis may facilitate the elimination of the antibiotic.

If a hypersensitivity reaction occurs, administration will be suspended, and the patient will be treated with the appropriate specific treatment for 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 forgot to use Gentamicina Braun 3 mg/ml:

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Gentamicina Braun 3 mg/ml

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following list of adverse reactions is presented according to the affected systems and in decreasing order of frequency according to the criteria:

Very frequent (1 in 10 patients), frequent (1 in 100 patients), infrequent (1 in 1,000 patients), rare (1 in 10,000 patients), and very rare (less than 1 in 100,000 patients)

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or nurse, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep this medication 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 shown on the packaging. The expiration date is the last day of the month indicated.

The contents of the vials must be used immediately after opening. Once the packaging is opened, discard any unused portion of the solution.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofGentamicin Braun 3 mg/ml

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

Each vial contains 3 mg/ml of gentamicin base.

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

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

Each bottle of 80 ml contains 240 mg of gentamicin

Each bottle of 100 ml contains 300 mg of gentamicin

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

Appearance of the product and contents of the package

It is presented in containers of 1 and 20 polyethylene bottles containing 80 ml and 100 ml of solution.

Holder of the marketing authorization and responsible for manufacturing

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

This leaflet was approved in October 2024.

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

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This information is intended solely for doctors or healthcare professionals:

They should carefully observe both renal and auditory nerve functions 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 dosage adjustment or suspension of treatment as needed.

Patients should be well-hydrated during treatment.

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

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

Handle in the usual conditions of asepsis in the use of intravenous infusion solutions.

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

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

PRESCRIPTION MEDICINE

B|BRAUN