Prospect: information for the user

Amicacina Braun 500 mg/2ml injectable solution

The medicationAmicacina Braun 500 mg/2mlis an aqueous solution of amikacin, a bactericidal antibiotic from the aminoglycoside group.

It is used for the short-term treatment of severe infections caused by sensitive microorganisms. It is mainly used in the following cases:

• Blood infection, also known as sepsis
• Severe lower respiratory tract infections
• Central nervous system infections (including meningitis)
• Intra-abdominal infections, including peritonitis
• Skin, bone, and soft tissue infections (including burns)
• Complicated and recurrent urinary tract infections
• Infections following surgical intervention

No use Amicacina Braun 500 mg/2ml:

• If you are allergic to amikacin or other aminoglycoside antibiotics,
• If you havemyasthenia gravis,
• Do not administer with other products that are toxic to the ear or kidney, or with potent diuretics,

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to use Amicacina Braun 500 mg/2ml.

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

• If you are allergic to amikacin or other aminoglycoside antibiotics,
• If your kidneys do not function well, as it may increase the risk of toxicity,
• If you have muscular 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 sensation), buzzing in the ears, and hearing loss or kidney toxicity symptoms appear.
• If you experience intense diarrhea,
• It is possible that your infection may not respond to amikacin 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 or your family members have a mitochondrial disease (a genetic disease) or hearing loss due to antibiotics, you are advised to inform your doctor or pharmacist before taking an aminoglycoside; certain mitochondrial mutations may increase your risk of hearing loss with this medication. Your doctor may recommend genetic testing before administering Amicacina Braun 500 mg/2ml,
• Amikacin may cause alterations in the values of some substances such as: urea nitrogen, transaminases, alkaline phosphatase, bilirubin, creatinine, lactate dehydrogenase, sodium, potassium, magnesium, and calcium.

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.
• Strictly according to renal function dosing.
• 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 amikacin concentrations during treatment if your case requires it.
• If you already have ear nerve damage (auditory or balance function deterioration), or if treatment is long-term, additional balance and auditory function monitoring is required.
• Treatment with amikacin should not exceed 10-14days (usually 7-10days).
• A sufficient time of 7-14days should elapse between individual treatments with amikacin and other closely related antibiotics.
• Avoid administering other substances with potential damaging effects on the auditory nerve or kidneys in combination with amikacin. If this is unavoidable, especially careful renal function monitoring is required.
• The level of body fluids and urine production should be within the normal range.

Children

This medication will be administered with caution and only if there is no other alternative in premature and newborn patients due to the incomplete renal development of these patients.

Other medications and Amicacina Braun 500 mg/2ml

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

The administration ofAmicacina Braun 500 mg/2mlwith the following medications may require modifying the dose of one of them or interrupting treatment.

-Other aminoglycoside antibiotics (gentamicin, tobramycin...) or capreomycin.

-Ampicillin, vancomycin, immunosuppressive agents, cytotoxic agents (toxic to cells such as cyclosporine or cisplatin), cephalosporins (cephalothin) or potent diuretics.

-Halogenated hydrocarbon anesthetics, massive blood transfusions with citrate, and neuromuscular blockers.

-Antihistamines, buclizine, cyclizine, loxapine, meclozine, phenothiazines, thioxanthenes, or trimethobenzamide.

-Anti-myasthenic agents (medications totreat myasthenia gravis - muscle weakness).

-Indomethacin.

-Malation.

-Polypeptide antibiotics (colistin, polymyxin).

-Opioid analgesics.

-Betalactam antibiotics (penicillin).

- Indomethacin intravenous in children.

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.

This medication is not recommended during pregnancy, although your doctor will evaluate its use. If the medication is used during pregnancy, or if you become pregnant during treatment, you should be informed of the possible risks.

No data are available on excretion in breast milk, but as a general rule, breastfeeding should not be performed while under treatment.

Driving and operating machinery:

No evidence of effects on the ability to drive vehicles or operate machinery is available. However, this ability may be impaired if adverse reactions such as dizziness, vertigo, and lethargy appear.

Amicacina Braun 500 mg/2ml contains sodium metabisulfite (E-223), methylparaben (E-218), and propylparaben (E-216).

This medication may cause severe allergic reactions and bronchospasm (sudden sensation of choking) due to the presence of sodium metabisulfite (E-223).

It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden sensation of choking) due to the presence of methylparaben (E-218) and propylparaben (E-216).

This medication contains less than 23 mg of sodium (1 mmol) per 2 ml vial; it is essentially "sodium-free".

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

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

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 should be monitored during treatment.

Concentrations above 35 micrograms/min (30-90 minutes after injection) and below 10 micrograms/min (just before the next dose) should be avoided.

For adults with normal renal function, the recommended dose is 15-20 mg/kg/day, administered as a single daily dose or divided into 2 or 3 equal doses at equivalent intervals.

Use in children

Adolescents (12 to less than 18 years) and children (2 to 11 years):

The recommended dosage is the same as for adults.

Newborns at term of 2 weeks or more and infants (28 days to 23 months):

The recommended dose in children over 2 weeks is 7.5 mg/kg every 12 hours or 5 mg/kg every 8 hours.

Newborns at term of less than 2 weeks (0 to 13 days):

A loading dose of 10 mg/kg should be administered, followed by 7.5 mg/kg every 12 hours.

Preterm infants:

The recommended dose is 7.5 mg/kg every 12 hours.

Amikacin Braun 500 mg/2ml may not be suitable for adjusting the dosage in all cases. Other presentations of intravenous solution may be used in this situation.

If the patient has impaired renal function, the doctor will closely monitor it and, if necessary, adjust the dose or extend the intervals between doses.

Amikacin Braun 500 mg/2 ml should be administered intramuscularly.

If you use more Amikacin Braun 500 mg/2ml than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or contact the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the leaflet to the healthcare professional.

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 should be discontinued, and the patient should be treated with the appropriate specific treatment for the nature and intensity of the reaction (antihistamines, corticosteroids, adrenaline, etc.).

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

Like all medicines, Amicacina Braun 500 mg may 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 (> 1/10), frequent (>1/100, <1>1/1000, <1>1/10000, <1>

Reporting of suspected adverse reactions

It is essential to report suspected adverse reactions to the medicine after its authorization. This allows for continuous monitoring of the benefit-risk ratio of the medicine. Healthcare professionals are invited to report suspected adverse reactions through the Spanish System of Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es

Keep out of the sight and reach of children.

Store in a cool place and in the original packaging to protect it from light.

Do not use Amicacina Braun 500 mg/2ml after the expiration date that appears 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 the unused portion of the solution.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

Composition ofAmicacina Braun 500 mg/2ml

The active ingredient of Amicacina Braun 500 mg/2ml is amikacin sulfate

Each vial contains 500 mg of amikacin base.

The other components are: methylparaben (E-218), propylparaben (E-216), sodium metabisulfite (E-223), disodium edetate, and water for injection preparations.

Appearance of the product and contents of the package

It is presented in containers containing 1 and 50 glass vials of 2 ml.

Holder of the marketing authorization and responsible for manufacturing

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Date of the last review of this leaflet:June 2023

The detailed information of this medication is available on the website of the Spanish Agency for 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 renal and auditory nerve function in patients with renal insufficiency, when used for long periods or when administered at doses higher than those recommended, as there have been reported disturbances of the VIII cranial nerve, as well as renal function. The appearance of signs of nephrotoxicity or ototoxicity will determine a dosage adjustment or suspension of treatment, as the case may be.

They should study plasma levels of amikacin, adjusting their dosage to avoid prolonged levels above 35 micrograms/ml. Urine should be examined to detect increases in protein excretion, the presence of cells or cylinders, and decreased density.

The ototoxicity in children is not well determined.

In case of appearing superinfections produced by resistant microorganisms, treatment should be suspended and the appropriate therapy applied.

Patients should be well hydrated during treatment.

Dosage

Patients with normal renal function can receive a single daily dose, as long as the maximum concentration does not exceed 35 mg/ml. The usual duration of treatment is 7 to 10 days.

In difficult and complicated infections, a longer treatment may be necessary. In these cases, renal, auditory (cochlear), and vestibular functions will be monitored.

The recommended dose for adults, adolescents, and children over 2 years is 15-20 mg/kg/day in the form of a single daily dose or divided into two or three equal doses administered at equivalent intervals (i.e., for a dose of 15 mg/kg/day, it is administered divided into doses of 7.5 mg/kg every 12 hours or 5 mg/kg every 8 hours).

The total dose should not exceed 1.5 g/day.

Pediatric population

Newborns at term of 2 weeks or more and infants (28 days to 23 months):

The recommended dose in children over 2 weeks is 7.5 mg/kg every 12 h or 5 mg/kg every 8 h.

Newborns at term of less than 2 weeks (0 to 13 days):

A first loading dose of 10 mg/kg will be administered, followed by 7.5 mg/kg every 12 hours.

Preterm infants:

The recommended dose is 7.5 mg/kg every 12 hours.

Amicacina Braun 500 mg/2ml may not be suitable for adjusting the dosage in all cases. Other presentations of intravenous infusion solution may be used in this situation.

Special populations

Renal insufficiency

In patients with renal insufficiency, measured by a creatinine clearance <50

The dosage may be adjusted by either increasing the interval between doses or by administering reduced doses.

Dosage adjustment based on serum creatinine values:

1. Increase the dosing interval, at the normal dose:

The increase in the interval in hours for a normal dosage (7.5 mg/kg every 12 hours) can be calculated by multiplying the value of serum creatinine by 9. For example, if the value of serum creatinine is 2 mg/100 ml, the recommended dosage would be 7.5 mg/kg every 18 hours.

2. Modification of the dose, maintaining the interval between administrations:

Initially, the normal dose of 7.5 mg/kg will be administered as a loading dose. To determine the maintenance dose to be administered every 12 hours, the dose should be reduced in proportion to the reduction in creatinine clearance:

Maintenance dose (every 12 h):

Obese patients

The dose should be adjusted to body weight and renal function. In obese patients, the initial dose should be calculated with the ideal weight plus a 40% excess of weight.

Patients with burns and with severe infections

They may require a higher dose or administration at intervals of four to six hours due to the shorter half-life of the drug in these cases.

Administration form

Intramuscular direct route.

Monitoring recommendations:

To calculate the correct dose, the following should be taken into account:

• The patient's weight before treatment.
• The state of renal function, determining the concentration of serum creatinine or creatinine clearance. Renal function should be monitored during treatment.

Whenever possible, serum amikacin concentrations should be determined to ensure adequate levels. It is recommended to measure serum concentrations intermittently during treatment. Concentrations above 35 µg/ml (30-90 minutes after injection) and above 10 µg/ml (just before the next dose) should be avoided.

Aminoglycosides should be administered separately, regardless of the administration route, and should not be physically pre-mixed with other drugs.

DRUG SUBJECT TO PRESCRIPTION BY A DOCTOR

HOSPITAL USE