AMIKACIN 10 mg /Ml Solution

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. Amikacin B. Braun, 5 mg/ml, solution for infusion
   2. Amikacin B. Braun, 10 mg/ml, solution for infusion
   3. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   4. Table of contents of the leaflet
2. What is Amikacin B. Braun and what is it used for
3. Important information before using Amikacin B. Braun
   1. When not to use Amikacin B. Braun
   2. Warnings and precautions
   3. Amikacin B. Braun and other medicines
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
   6. Important information about some ingredients of Amikacin B. Braun
4. How to use Amikacin B. Braun
   1. Duration of treatment
   2. Dosing in patients with normal kidney function
   3. Dosing in patients with kidney function disorders
   4. Dosing in patients undergoing hemodialysis or peritoneal dialysis
   5. Elderly patients
   6. Patients with significant overweight
   7. Patients with ascites
   8. Administration of a higher dose of Amikacin B. Braun than recommended
5. Possible side effects
   1. The following adverse reactions may be severe and require immediate treatment.
   2. Other side effects
   3. Reporting side effects
6. How to store Amikacin B. Braun
7. Contents of the packaging and other information
   1. What Amikacin B. Braun contains
   2. What Amikacin B. Braun looks like and contents of the packaging
   3. Marketing authorization holder and manufacturer
   4. This medicine is authorized in the Member States of the European Economic Area under the following names:
   5. Date of last revision of the leaflet: 08.01.2025
   6. Patient monitoring
   7. Incompatibilities
   8. Shelf life
   9. Dosing
   10. Volume of infusion solution in patients with normal kidney function

Leaflet attached to the packaging: patient information

Amikacin B. Braun, 2.5 mg/ml, solution for infusion

Amikacin B. Braun, 5 mg/ml, solution for infusion

Amikacin B. Braun, 10 mg/ml, solution for infusion

Amikacin

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Amikacin B. Braun and what is it used for

Amikacin B. Braun belongs to a group of medicines called antibiotics. They are used to treat severe infections caused by bacteria sensitive to the active substance - amikacin. Amikacin belongs to a group of substances called aminoglycosides. The patient may receive amikacin to treat the following diseases:

• lung and lower respiratory tract infections, occurring during hospital treatment, including severe pneumonia;
• infections in the abdominal cavity, including peritonitis;
• complicated and recurrent kidney, urinary tract, and bladder infections;
• skin and soft tissue infections, including severe burns;
• bacterial endocarditis;
• infections after abdominal surgery.

Amikacin B. Braun can also be used to treat patients who have an inflammatory condition of the internal organs associated with any of the above-mentioned infections or who are suspected of having a connection with any of the above-mentioned infections.

2. Important information before using Amikacin B. Braun

When not to use Amikacin B. Braun

• If the patient is allergic (hypersensitive) to amikacin, other similar substances (other aminoglycosides), or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Amikacin B. Braun, the patient should discuss it with their doctor. Particular caution should be exercised when using Amikacin B. Braun if the patient:

• has kidney function disorders,
• has hearing disorders,
• has neuromuscular disorders, such as a disease called myasthenia (a specific type of muscle weakness),
• suffers from Parkinson's disease,
• if the patient or their family members have a disease related to mitochondrial mutation (a genetic disease) or hearing loss caused by the use of antibiotics, it is recommended to inform the doctor or pharmacist before taking an aminoglycoside; some mitochondrial mutations may increase the risk of hearing loss after taking this medicine. Before administering Amikacin B. Braun, the doctor may recommend genetic testing,
• has been previously treated with another antibiotic similar to amikacin. In each of these situations, the doctor will exercise particular caution.

If the patient is affected by any of the following factors, there is a greater risk of harmful effects on hearing or nerves:

• impaired kidney function,
• advanced age (≥60 years),
• dehydration,
• receiving high doses of this medicine,
• treatment lasting longer than 5-7 days, even in patients who have already been cured.

The first symptoms of harmful effects on hearing or nerves, occurring after administration of this medicine, may be:

• hearing problems with high sounds (hearing loss covering high frequencies),
• dizziness,
• a feeling of numbness and tingling of the skin, muscle cramps, seizures.

After administration of the medicine, respiratory arrest (paralysis of respiratory muscles) and inhibition of nerve and muscle function (neuromuscular blockade) may occur. In such a situation, the doctor will use appropriate treatment. Elderly patients The doctor will pay particular attention to kidney function in elderly patients. The doctor may perform several tests to ensure that there has been no harmful effect on the kidneys, as the risk of kidney function disorder is higher in elderly patients. Children It is also necessary to exercise caution when using the medicine in premature infants or full-term newborns, due to immature kidney function. During treatment with this medicine, the doctor will closely monitor the patient, paying particular attention to hearing and kidney function. The following will be monitored in the patient:

• kidney function, especially in patients with kidney failure or symptoms of kidney failure that occurred during treatment,
• hearing,
• amikacin concentration in the blood (if necessary).

If the patient experiences or worsens symptoms of kidney failure, the doctor will reduce the daily dose and (or) extend the intervals between individual doses. If severe kidney failure occurs, amikacin administration will be discontinued. Treatment with amikacin should also be discontinued if tinnitus or hearing loss occurs. If the patient is irrigated with amikacin or a similar antibiotic during surgery, this will be taken into account when calculating the amikacin dose.

Amikacin B. Braun and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The harmful effect of amikacin on the kidneys and hearing nerve may be increased by:

• other antibiotics similar to amikacin (e.g., kanamycin, paromomycin),
• other substances used to treat infections, such as bacitracin, amphotericin B, cephalosporins, vancomycin, polymyxins (polymyxin B, colistin), viomycin,
• anticancer medicines: carboplatin (in high doses), cisplatin, oxaliplatin (especially if the patient has previously had kidney function disorders),
• substances that inhibit unwanted immune reactions: cyclosporine, tacrolimus,
• rapidly acting diuretics: furosemide or ethacrynic acid (which can lead to hearing damage, as dehydration leads to high amikacin concentrations),
• methoxyflurane used for anesthesia: the anesthesiologist should know that the patient received or is receiving amikacin or a similar antibiotic before using methoxyflurane anesthesia and, if possible, avoid this gas due to the increased risk of severe kidney or nerve damage.

If it is necessary to use amikacin together with the above-mentioned substances, frequent and thorough checks of hearing and kidney function will be performed. If amikacin is used together with rapidly acting diuretics, fluid balance will be monitored. Concurrent treatment with amikacin and muscle relaxants or other substances affecting muscles and nerves The doctor will monitor the patient particularly closely if they receive amikacin together with muscle relaxants (such as succinylcholine, decamethonium, atracurium, rocuronium, vecuronium), a large volume of blood with an anticoagulant (citrate), or anesthetics: respiratory arrest (muscle paralysis) may occur. If the patient is treated with amikacin, they should inform the anesthesiologist before surgery due to the risk of significant enhancement of neuromuscular blockade. If aminoglycosides cause neuromuscular blockade, it can be reversed with calcium salts. Indomethacin In newborns receiving amikacin and indomethacin (an anti-inflammatory and analgesic) at the same time, the amikacin concentration in the blood will be closely monitored. Indomethacin may increase the amikacin concentration in the blood. Bisphosphonates Concurrent use with bisphosphonates (used to treat osteoporosis and similar diseases) is associated with a high risk of decreased calcium levels in the blood (hypocalcemia).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine. Pregnancy If the patient is pregnant, they will only receive this medicine if it is absolutely necessary. Breastfeeding Although it is unlikely that amikacin will be absorbed from the intestine of a breastfed child, the doctor will carefully consider whether to stop breastfeeding or treatment with amikacin. Fertility Animal studies have not shown any effect on fertility.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines. If the patient receives the medicine in an outpatient setting, it is recommended to exercise caution when driving and using machines due to possible side effects such as dizziness and balance disorders.

Important information about some ingredients of Amikacin B. Braun

This medicine contains 354 mg of sodium in the form of salt (the main component of table salt) per 100 ml of solution, which corresponds to 17.7% of the recommended maximum daily intake of sodium for adults.

3. How to use Amikacin B. Braun

Amikacin B. Braun is administered by intravenous infusion directly into a vein. The contents of one vial are administered over 30-60 minutes.

Duration of treatment

Amikacin treatment is usually used for 7-10 days, and longer only in severe and complicated infections. The effects of treatment are usually visible after 24 to 48 hours; otherwise, a change of medicine may be necessary. In such a situation, the doctor will assess the patient's condition and consider possible changes in treatment. The appropriate dose for the patient is determined by the doctor. The following are the usual doses used.

Dosing in patients with normal kidney function

• Adults and adolescents over 12 years old (body weight over 33 kg) The usual dose is 15 mg of amikacin per kg of body weight per 24 hours, administered in a single dose or divided into two equal doses: 7.5 mg per kg every 12 hours. A maximum of 1.5 grams per day can be administered for a short time if it is absolutely necessary to administer such high doses and if it is possible to closely and constantly monitor the patient during treatment.
• Infants, young children, and children The single daily dose of amikacin is 15-20 mg/kg or 7.5 mg/kg every 12 hours.
• Dosing in newborns The initial dose is 10 mg of amikacin per kg of body weight, and after 12 hours, 7.5 mg of amikacin per kg of body weight should be administered. Treatment should be continued, administering 7.5 mg of amikacin per kg of body weight every 12 hours.
• Dosing in premature infants 7.5 mg of amikacin per kg of body weight every 12 hours.

This does not apply to patients with impaired immunity, kidney failure, cystic fibrosis, ascites, endocarditis, or extensive burns (covering more than 20% of the skin), elderly patients, or pregnant women. During treatment, the amikacin concentration in the blood will be closely monitored, and the dose will be carefully adjusted.

Dosing in patients with kidney function disorders

If patients have kidney function disorders, their amikacin blood levels and kidney function will be regularly and closely monitored to adjust the dose accordingly. The doctor knows how to calculate the dose to be administered to the patient.

Dosing in patients undergoing hemodialysis or peritoneal dialysis

In this group of patients, it may be necessary to modify the amikacin dose. The doctor will ensure that the correct dose has been determined for the patient.

Elderly patients

To achieve therapeutic concentrations in the serum of elderly patients, it may be necessary to use smaller doses of amikacin than in younger patients. As soon as possible, kidney function will be assessed, and the dose will be adjusted if necessary.

Patients with significant overweight

In these patients, the dose is calculated based on the ideal body weight plus 40% of the excess weight. The dose can then be adjusted based on the amikacin concentration in the blood. The doctor will not administer a dose greater than 1.5 grams of amikacin per day.

Patients with ascites

Higher doses should be administered to achieve appropriate blood levels of the medicine.

Administration of a higher dose of Amikacin B. Braun than recommended

Overdose can cause kidney and hearing nerve damage or muscle paralysis. In such a case, the amikacin infusion will be discontinued, and procedures to remove the medicine from the blood (dialysis, hemofiltration) may be used. In newborns, exchange transfusion may be considered, but before implementing such treatment, specialist advice should be sought. If neuromuscular blockade with respiratory arrest occurs, the doctor will use all necessary treatment methods. To reverse muscle paralysis, calcium salts (e.g., in the form of gluconate or lactobionate in a 10-20% solution) can be used. In case of respiratory arrest, mechanical ventilation may be necessary. If there are any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Amikacin B. Braun can cause side effects, although not everybody gets them. Amikacin (and all other similar substances) can be toxic to the hearing nerve and kidneys, as well as block neuromuscular conduction. Such effects are most commonly observed in patients:

• with kidney function disorders,
• being treated with other medicines that also have harmful effects on the hearing nerve and kidneys, and
• receiving excessive doses or being treated for a long time.

Side effects that may be caused by treatment are listed below according to their absolute frequency of occurrence.

The following adverse reactions may be severe and require immediate treatment.

Very rare (may occur in less than 1 in 10,000 patients):

• respiratory arrest (paralysis of respiratory muscles).

Frequency not known (frequency cannot be estimated from the available data):

• allergic reactions, up to anaphylactic shock,
• deafness (irreversible),
• acute kidney failure, kidney damage,
• paralysis.

Other side effects

Uncommon (may occur in less than 1 in 100 patients):

• superinfection or colonization with resistant microorganisms,
• dizziness, balance disorders,
• nausea, vomiting,
• damage to certain parts of the kidneys (renal tubules),
• rash.

Rare (may occur in up to 1 in 1,000 patients):

• anemia, increased number of certain types of white blood cells (eosinophilia),
• itching, hives,
• low magnesium levels in the blood,
• headache, numbness, tremors, balance disorders,
• low blood pressure,
• joint pain, uncontrolled muscle movements,
• decreased urine output, presence of albumin, white and/or red blood cells in the urine,
• increased creatinine and/or other nitrogenous compounds in the blood (oliguria, azotemia),
• drug fever,
• blindness or other vision disorders*,
• tinnitus (ringing in the ears), slight hearing loss (hearing loss).

* This medicine is not intended for use in the eye. Blindness and retinal infarction have been reported after injection of this medicine into the eye. Frequency not known (frequency cannot be estimated from the available data):

• presence of cells in the urine,
• respiratory arrest, bronchospasm.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: (22) 4921 301, fax: (22) 4921 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Amikacin B. Braun

The medicine should be stored out of sight and reach of children. Do not use Amikacin B. Braun after the expiry date stated on the vial and outer packaging. The expiry date refers to the last day of the month stated. There are no special precautions for the storage of this medicinal product. The infusion solution should be used immediately. For single use only. Any unused product or waste material should be disposed of. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Amikacin B. Braun contains

• The active substance of the medicine is amikacin.

1 ml of Amikacin B. Braun, 2.5 mg/ml, solution for infusion, contains 2.5 mg of amikacin in the form of amikacin sulfate. 1 vial of 100 ml contains 250 mg of amikacin. 1 ml of Amikacin B. Braun, 5 mg/ml, solution for infusion, contains 5 mg of amikacin in the form of amikacin sulfate. 1 vial of 100 ml contains 500 mg of amikacin. 1 ml of Amikacin B. Braun, 10 mg/ml, solution for infusion, contains 10 mg of amikacin in the form of amikacin sulfate. 1 vial of 100 ml contains 1000 mg of amikacin.

• The medicine also contains: sodium chloride, sodium hydroxide (for pH adjustment), water for injections.

What Amikacin B. Braun looks like and contents of the packaging

Amikacin B. Braun is a clear, colorless solution for infusion. It is available in polyethylene vials of 100 ml. It is supplied in packs of 10 and 20 vials. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

• B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany Tel: +49-5661-71-0 Fax: +49-5661-71-4567

Manufacturer

• B. Braun Medical S. A. Carretera de Terrassa 121 08191 Rubí (Barcelona) Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria Amikacin B. Braun 2.5 mg/ml Infusionslösung Amikacin B. Braun 5 mg/ml Infusionslösung Belgium Amikacine B. Braun 5 mg/ml Solution pour perfusion, Oplossing voor infusie, Infusionslösung Amikacine B. Braun 10 mg/ml Solution pour perfusion, Oplossing voor infusie, Infusionslösung Bulgaria Амикацин Б. Браун 5 mg/ml инфузионен разтвор Амикацин Б. Браун 10 mg/ml инфузионен разтвор Czech Republic Amikacin B. Braun 5 mg/ml Amikacin B. Braun 10 mg/ml Germany Amikacin B. Braun 2.5 mg/ml Infusionslösung Amikacin B. Braun 5 mg/ml Infusionslösung Amikacin B. Braun 10 mg/ml Infusionslösung Estonia Amikacin B. Braun 5 mg/ml Amikacin B. Braun 10 mg/ml Greece Amikacin B. Braun 5 mg/ml διάλυμα για έγχυση France AMIKACINE B. Braun 2.5 mg/ml, solution pour perfusion AMIKACINE B. Braun 5 mg/ml, solution pour perfusion AMIKACINE B. Braun 10 mg/ml, solution pour perfusion Hungary Amikacin B. Braun 5 mg/ml oldatos infúzió Italy Amikacina B. Braun 5 mg/ml soluzione per infusione Amikacina B. Braun 10 mg/ml soluzione per infusione Luxembourg Amikacin B. Braun 2.5 mg/ml Infusionslösung Amikacin B. Braun 5 mg/ml Infusionslösung Amikacin B. Braun 10 mg/ml Infusionslösung Latvia Amikacin B. Braun 5 mg/ml šķīdums infūzijām Amikacin B. Braun 10 mg/ml šķīdums infūzijām Poland Amikacin B. Braun, 2.5 mg/ml, solution for infusion Amikacin B. Braun, 5 mg/ml, solution for infusion Amikacin B. Braun, 10 mg/ml, solution for infusion Slovakia Amikacin B. Braun 5 mg/ml Amikacin B. Braun 10 mg/ml

Date of last revision of the leaflet: 08.01.2025

--------------------------------------------------------------------------------------------------------------------------- Information intended for healthcare professionals only: Neurotoxicity and ototoxicity In patients treated with aminoglycoside antibiotics, toxic effects on the nervous system may occur, manifesting as vestibular and/or auditory toxicity. The risk of ototoxicity associated with aminoglycosides is higher in patients with kidney function disorders and in patients receiving the medicine for longer than 5-7 days, even in patients who have already been cured. The first symptom to appear is usually high-frequency hearing loss, which can only be detected by audiometry. Severe dizziness may occur, indicating damage to the vestibular nerve. Other symptoms of toxic effects on the nervous system may include a feeling of numbness and tingling of the skin, muscle cramps, and seizures. Ototoxic effects of aminoglycosides are usually irreversible. Toxic effects on neuromuscular conduction During treatment with aminoglycosides, regardless of the route of administration, the possibility of respiratory muscle paralysis should be considered, especially in patients receiving other medicines that block neuromuscular conduction. If neuromuscular blockade occurs, administration of calcium salts may reverse muscle paralysis, but mechanical ventilation may be necessary. Neuromuscular blockade and muscle paralysis have been demonstrated in laboratory animals administered high doses of amikacin. Effect on laboratory tests The results of serum creatinine measurement may be falsely elevated if cephalosporins are administered concurrently. Inactivation of amikacin and beta-lactam antibiotics may also occur in samples (e.g., serum, cerebrospinal fluid) taken for measurement of aminoglycoside concentrations, leading to incorrect results. Therefore, samples should be analyzed immediately after collection, stored in the refrigerator after collection, or the beta-lactam antibiotic should be inactivated by adding beta-lactamase. Inactivation of the aminoglycoside antibiotic is clinically significant only in patients with severe kidney function disorders.

Patient monitoring

Kidney function and the eighth cranial nerve should be closely monitored, especially in patients with known or suspected kidney function disorders at the start of treatment, as well as in patients with initially normal kidney function who develop signs of kidney function disorders during treatment. Whenever possible, amikacin concentrations in the serum should be monitored to ensure appropriate concentrations and avoid toxic concentrations. Urine tests should be performed to detect decreased specific gravity, increased proteinuria, and the presence of cells or casts. Periodically, blood urea nitrogen, serum creatinine, or creatinine clearance should be measured. Whenever possible, a series of audiograms should be performed in patients of appropriate age for the test, especially in high-risk patients. If symptoms of ototoxicity (peripheral or central dizziness, tinnitus, or sudden hearing loss) or nephrotoxicity occur, treatment should be discontinued or the dose adjusted.

Incompatibilities

Amikacin B. Braun, 2.5 mg/ml, 5 mg/ml, and 10 mg/ml, solution for infusion, are ready-to-use products. They should not be mixed with any other medicinal product; they should be administered separately, according to the recommended dose and method of administration. Aminoglycosides should not be mixed in an infusion solution with beta-lactam antibiotics (e.g., penicillins, cephalosporins), as this may cause physical-chemical inactivation of the second medicine. Chemical incompatibilities are known with amphotericin, chlorothiazide, erythromycin, heparin, nitrofurantoin, novobiocin, phenytoin, sulfadiazine, thiopental, chlortetracycline, vitamin B, and vitamin C. Amikacin should not be mixed with these medicinal products. Inactivation occurring during mixing of aminoglycosides and beta-lactam antibiotics may persist even when samples are taken for measurement of antibiotic concentrations in the serum and may lead to significant underestimation and errors in dosing, resulting in the risk of toxicity. These samples should be analyzed quickly and stored on ice or beta-lactamase should be added.

Shelf life

Before opening3 years After first opening of the containerFrom a microbiological point of view, the product should be used immediately. If not used immediately, the user is responsible for the storage period and conditions before use. The product should not be stored for longer than 24 hours at a temperature of 2°C to 8°C.

Dosing

Accurate administration of the Amikacin B. Braun, 2.5 mg/ml, 5 mg/ml, 10 mg/ml, solution for infusion, is possible if an infusion pump is used. This pharmaceutical form is ready to use, the solution should not be diluted before administration, and it is intended for single use only. To avoid overdose, especially in children, the most suitable of the available strengths should be chosen.

Volume of infusion solution in patients with normal kidney function

Patients with impaired kidney function (creatinine clearance <60 ml min)< h4>

Note. In patients with impaired kidney function (creatinine clearance <60 ml min), it is not recommended to administer amikacin once daily. due the expected accumulation of in patients with impaired kidney function and creatinine clearance <60 min, reduce dose or increase intervals between doses. this group patients, loading 7.5 mg kg body weight. doses are calculated by multiplying serum concentration 9. if, for example, 2 100 ml, single patient (7.5 weight) should be administered every × 9=18 hours. chronic failure known clearance, maintenance 12 hours using formula: [ml min] weight values given following table can used as a guide. obtain full information about medicinal product, consult summary product characteristics.< p>

Creatinine clearance	Daily amikacin dose	Amikacin dose every 12 hours for a patient with a body weight of 70 kg
[ml/min]	[mg/kg body weight per day]	[mg]
50 – 59 40 – 49 30 – 39 20 – 29 15 – 19	5.4 – 6.4 4.2 – 5.4 3.2 – 4.2 2.1 – 3.1 1.6 – 2.0	186 – 224 147 – 186 112 – 147 77 – 112 56 – 77