Amikacin Kabi

Leaflet accompanying the packaging: information for the user

Amikacin Kabi, 5 mg/mL, solution for infusion

Amikacin

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Amikacin Kabi and what is it used for

Amikacin Kabi contains the active substance amikacin. It belongs to a group of medicines called antibiotics. They are used to treat severe infections caused by bacteria that are sensitive to 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 hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP);
• complicated kidney, urinary tract, and bladder infections;
• complicated abdominal cavity infections, including peritonitis;
• skin and soft tissue infections, including severe burns;
• bacterial endocarditis (infection of the membrane lining the inner surfaces of the heart) (only in combination therapy with other antibiotics). Amikacin Kabi can also be used to treat patients who have inflammation of internal organs associated with any of the above infections or who are suspected of having such an association.

2. Important information before using Amikacin Kabi

When not to use Amikacin Kabi:

Warnings and precautions

Before starting treatment with Amikacin Kabi, you should discuss it with your doctor, pharmacist, or nurse. You should inform your doctor if the patient:

• has kidney function disorders;
• has hearing disorders;
• has neuromuscular disorders, such as a specific type of muscle weakness called myasthenia;
• suffers from Parkinson's disease;
• has been previously treated with another antibiotic similar to amikacin. In each of these situations, the doctor will exercise special caution.

If the patient or their family members have a disease associated with 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 aminoglycoside antibiotics; some mitochondrial mutations may increase the risk of hearing loss after using this medicine. Before administering Amikacin Kabi, the doctor may recommend genetic testing. The doctor will also exercise special caution if the patient is 60 years old or older or if the patient is dehydrated (has a water deficiency in the body). During treatment, the doctor will monitor the patient's condition, including:

• kidney function, especially if the patient is 60 years old or older or has kidney function disorders;
• hearing;
• amikacin concentration in the blood, if necessary.

If the patient experiences or worsens symptoms of kidney function disorders, the daily dose should be reduced and/or the intervals between individual doses should be extended. If severe kidney function disorders occur, amikacin administration will be discontinued. Amikacin treatment should also be discontinued if the patient experiences tinnitus or hearing loss. To avoid the risk of kidney, nerve, and muscle damage, Amikacin Kabi should not be used for more than 10 days, unless the doctor considers it necessary. During treatment, the patient should be provided with adequate fluid intake. If the patient had wounds flushed with amikacin or a similar antibiotic during surgery, this should be taken into account when calculating the amikacin dose.

Children

Caution should be exercised when administering this medicine to premature and newborn infants due to their kidney immaturity.

Amikacin Kabi and other medicines

You should tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. The harmful effect of Amikacin Kabi on the kidneys and hearing nerve may be enhanced by the use of the following medicines:

• other antibiotics similar to amikacin;
• other substances used to treat infections, such as bacitracin, amphotericin B, penicillin or cephalosporin antibiotics, vancomycin, kanamycin, paromomycin, polymyxin B, colistin;
• anticancer medicines: carboplatin (in high doses), cisplatin, oxaliplatin (especially if the patient has previously had kidney function disorders);
• substances that suppress unwanted immune reactions: cyclosporine, tacrolimus;
• rapidly acting diuretics: furosemide or ethacrynic acid (may lead to irreversible hearing damage);
• bisphosphonates (used to treat osteoporosis and similar diseases);
• thiamine (vitamin B), as it may reduce its effectiveness;
• indomethacin (an anti-inflammatory medicine used to reduce fever, pain, and swelling and stiffness of the joints). This may lead to an increased concentration of Amikacin Kabi in the blood of newborns.

It is recommended to avoid administering the above medicines simultaneously or after administering Amikacin Kabi, if possible. If it is necessary to use amikacin together with the above 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.

Also, caution should be exercised during:

• Anesthesia with methoxyflurane Before starting methoxyflurane anesthesia (an anesthetic gas), the anesthesiologist should check if the patient has received or is receiving amikacin or a similar antibiotic. This should be avoided due to the increased risk of severe kidney and nerve damage.
• Concomitant use of amikacin with muscle relaxants (e.g., d-tubocurarine), other curare-like agents, botulinum toxins, or anesthetic gases such as halothane If the patient is being treated with amikacin, the anesthesiologist should be informed before surgery, due to the risk of significant enhancement of neuromuscular blockade. If aminoglycosides cause neuromuscular blockade, it can be reversed with calcium salts. In newborns receiving Amikacin Kabi and indomethacin (an anti-inflammatory and analgesic medicine) concomitantly, the amikacin concentration in the blood will be closely monitored. Indomethacin may increase the amikacin concentration in the blood.
• Use with other antibiotics Combination therapy with appropriate antibiotics may significantly enhance the treatment effect.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Pregnancy If the patient is pregnant, they will only receive this medicine if the doctor considers it absolutely necessary. Breastfeeding Although it is unlikely that amikacin will be absorbed from the breastfed infant's gut, the doctor will carefully consider whether to stop breastfeeding or amikacin treatment.

Driving and using machines

No studies have been conducted on the effect of amikacin on the ability to drive and use machines. If the patient is receiving amikacin on an outpatient basis, they should be cautious when driving and using machines, due to possible side effects such as dizziness of central or vestibular origin.

Amikacin Kabi contains sodium

This medicine contains 177 mg of sodium (the main component of common salt) in 50 mL. This corresponds to 8.85% of the maximum recommended daily sodium intake in the diet for adults. This medicine contains 354 mg of sodium (the main component of common salt) in 100 mL. This corresponds to 17.7% of the maximum recommended daily sodium intake in the diet for adults. This medicine contains 708 mg of sodium (the main component of common salt) in 200 mL. This corresponds to 35.4% of the maximum recommended daily sodium intake in the diet for adults.

3. How to use Amikacin Kabi

Amikacin Kabi is administered by infusion, directly into a vein (intravenous infusion). The duration of the infusion can range from 30 to 60 minutes. The dose suitable for the individual patient is determined by the doctor. The following are the usual doses used.

Patients with normal kidney function

Adults and adolescents aged 12 years and older (body weight over 33 kg) The usual dose is 15 mg of amikacin per kg of body weight (bw) per 24 hours, administered in a single dose or divided into two equal doses: 7.5 mg per kg bw every 12 hours. The maximum dose the patient can receive is up to 1.5 grams per day for a short period, if the doctor considers it absolutely necessary (e.g., life-threatening infections and/or infections caused by certain bacteria, such as Pseudomonas, Acinetobacter, or Enterobacteriales) and if it is possible to closely monitor the patient during treatment. The total amount of amikacin the patient can receive during the entire treatment will not exceed 15 grams. Infants, young children, and children (aged 4 weeks to 11 years) The single daily dose of amikacin is 15 to 20 mg/kg bw or a dose of 7.5 mg/kg bw administered every 12 hours. Newborns (aged 0 to 27 days) The initial dose is 10 mg of amikacin per kg bw, and after 12 hours, 7.5 mg of amikacin per kg bw should be administered. Treatment should be continued, administering 7.5 mg of amikacin per kg bw every 12 hours. Premature infants 7.5 mg of amikacin per kg bw every 12 hours.

Special patient groups

It is not recommended to administer a single daily dose to patients with impaired immunity, kidney failure, cystic fibrosis, ascites, endocarditis, or extensive burns (covering more than 20% of the skin) and to pregnant women. Patients with kidney function disorders If the patient has kidney function disorders, the amikacin concentration in the blood and kidney function will be closely monitored at regular intervals to adjust the dose accordingly. The doctor knows how to calculate the dose to be administered. Patients undergoing hemodialysis or peritoneal dialysis Patients in this group receive half the normal dose at the end of dialysis. Elderly patients In elderly patients, kidney function may be decreased. Whenever possible, kidney function will be assessed and the dose adjusted if necessary. Overweight patients 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 maximum dose is 1.5 grams of amikacin per day. The duration of treatment is usually 7-10 days. Patients with ascites Higher doses are necessary to achieve adequate blood levels of the medicine. Duration of treatment The duration of treatment is usually 7-10 days. It may be longer only in the case of severe and complicated infections. The effects of treatment usually appear in the patient within 24-48 hours; otherwise, a change of medicine may be necessary. The amikacin concentration in the blood will be closely monitored in all patients, with special attention to elderly patients, newborns, overweight patients, and patients with kidney function disorders or cystic fibrosis, and the dose will be carefully adjusted during treatment.

Administration of a higher dose of Amikacin Kabi than recommended

If the patient believes they have received a higher dose than recommended, they should immediately consult their doctor or nurse. Overdose may cause kidney and hearing nerve damage or muscle paralysis. In such a case, the amikacin infusion will be discontinued. In case of any further doubts regarding the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. In patients treated with amikacin, toxic effects on the hearing nerve and kidneys have been observed. These adverse effects can be prevented by strictly following the contraindications and cautiously determining the dosage by the doctor, in accordance with the recommendations. The doctor will monitor the signs of adverse effects.

In case of noticing any of the following serious side effects, you should immediately contact your doctor:

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

• swelling of the face, lips, or tongue, skin rash, difficulty breathing, these may be symptoms of an allergic reaction;
• ringing in the ears or hearing loss (deafness);
• respiratory muscle paralysis;
• kidney function disorders, including decreased urine output (acute kidney failure).

Other side effects:

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

• dizziness, balance disorders;
• involuntary eye movements (nystagmus);
• additional infection or colonization (by yeast-like fungi called Candida);
• ringing in the ears, feeling of pressure in the ears, hearing disorders;
• nausea;
• damage to certain parts of the kidneys, kidney function disorders.

Rare (may occur in less than 1 in 1,000 patients):

• abnormally low white or red blood cell or platelet count, increased count of certain white blood cells (eosinophilia);
• allergic reactions, skin rash, itching, hives;
• low magnesium level in the blood;
• headache, migraine, numbness, tremors;
• blindness or other vision disorders;
• low blood pressure;
• respiratory depression;
• vomiting;
• joint pain;
• drug fever;
• increased activity of certain liver enzymes in the blood.

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

• muscle blockade;
• acute kidney failure.

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

• allergic reactions to antibiotics similar to amikacin (aminoglycosides).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amikacin Kabi

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the bottle and carton. The expiry date refers to the last day of the month stated. There are no special precautions for storing the medicine. Shelf-life after first opening/reconstitution:Chemical and physical stability of the medicine has been demonstrated for 24 hours at 25°C and from 2°C to 8°C. From a microbiological point of view, the medicine should be used immediately. If the medicine is not used immediately, the responsibility for the storage time and conditions before use lies with the user, and this time should not normally exceed 24 hours at 2°C to 8°C, unless the opening/reconstitution has been carried out under controlled and validated aseptic conditions. Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Kabi contains

• The active substance of the medicine is amikacin.

One mL of the solution for infusion contains 5 mg of amikacin (as amikacin sulfate). One 50 mL bottle of solution contains 250 mg of amikacin. One 100 mL bottle of solution contains 500 mg of amikacin. One 200 mL bottle of solution contains 1000 mg of amikacin.

• The other ingredients are sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injections.

What Amikacin Kabi looks like and contents of the pack

Amikacin Kabi is a solution for infusion, administered by drip through a small tube or cannula placed in a vein. It is a clear, colorless, aqueous solution. Amikacin Kabi is available in a KabiPac bottle made of LDPE, closed with a PP or PE/PP cap with a rubber disk allowing needle insertion, in a cardboard box. Pack sizes: 10 x 50 mL, 10 x 100 mL, and 10 x 200 mL solution for infusion. Not all pack sizes may be marketed.

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw

Manufacturer

Fresenius Kabi Polska Sp. z o.o., ul. Sienkiewicza 25, 99-300 Kutno For more detailed information on this medicine, please contact the marketing authorization holder: Fresenius Kabi Polska Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw, tel.: +48 22 345 67 89

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

Date of last revision of the leaflet:10.04.2024

Information intended for healthcare professionals only:

Incompatibilities

Amikacin Kabi is a ready-to-use medicine and should not be mixed with any other medicines (except those listed below), and should be administered separately, in accordance with the recommended dose and method of administration. Aminoglycosides should not be mixed in a solution for infusion with beta-lactam antibiotics (e.g., penicillins, cephalosporins), as this may cause physical-chemical inactivation of the second medicine. Chemical incompatibilities with amphotericin, chlorothiazide, erythromycin, heparin, nitrofurantoin, novobiocin, phenytoin, sulfadiazine, thiopental, chlortetracycline, vitamin B, and vitamin C are known. Amikacin should not be mixed with these medicines.

Special precautions for disposal of unused medicinal products or waste materials

For single use only. Any unused medicine should be disposed of. Dilution should be performed under aseptic conditions. Before administration, the solution should be inspected for particulate matter or discoloration. Only a clear solution free from particles should be used. Amikacin Kabi is compatible with the following solutions for infusion:

• Ringer's solution;
• Ringer's solution with lactate;
• sodium chloride 9 mg/mL (0.9%) solution for injection;
• glucose 5 mg/mL (5%) solution for injection;
• glucose 10 mg/mL (10%) solution for injection.

Storage

See section 5: "How to store Amikacin Kabi".

Administration

See section 3: "How to use Amikacin Kabi".

Dosing

See section 3: "How to use Amikacin Kabi". Amikacin Kabi should be administered only by intravenous infusion, with a duration of infusion of 30 to 60 minutes. Volumes of the solution for infusion in patients with normal kidney function:

The accuracy of Amikacin Kabi dosing is greater if an infusion pump is used.

Instructions for dilution

Before administering Amikacin Kabi to children and adolescents, it is recommended to dilute it. To obtain amikacin at a concentration of 2.5 mg/mL, suitable for the selected dose, the corresponding amount (in mL) of Amikacin Kabi, 5 mg/mL, should be mixed with an equal amount of one of the above-mentioned solutions for infusion. Children and adolescents should receive an infusion lasting 1 to 2 hours. Volumes of the diluted solution for infusion 2.5 mg/mL amikacin:

Treatment of overdose

In case of overdose or symptoms of toxicity, amikacin infusion should be discontinued, and forced diuresis can be used to accelerate the elimination of amikacin from the blood. Peritoneal dialysis and hemodialysis can contribute to the elimination of amikacin that accumulates in the blood. Hemodialysis is more effective in removing amikacin from the blood than peritoneal dialysis. In newborns, exchange transfusion may be considered, but before using such a measure, it is necessary to consult a specialist. To counteract the muscle relaxant effect, calcium salts can be administered. If respiratory muscle paralysis occurs, mechanical ventilation may be necessary.