AMIKACIN KABI 5 mg/ml SOLUTION FOR INFUSION

2. What you need to know before you use Amikacina Kabi

Do not use Amikacina Kabi

• if you are allergic to amikacina or any of the other components of this medicine (listed in section 6).
• if you are allergic to other similar substances (other aminoglycosides),

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Amikacina Kabi.

Tell your doctor if you have:

• kidney problems
• hearing problems
• muscle and nerve disorders, such as Myasthenia gravis, a condition that causes muscle weakness.
• Parkinson's disease.
• have been treated with another antibiotic similar to amikacina.

Your doctor will take the necessary precautions if you are in any of the above situations.

Your doctor will also take the necessary precautions if you are 60 years or older, or if you are dehydrated (have a water deficit).

Your doctor will perform checks during treatment, including:

• kidney function, especially if you are 60 years or older or have kidney problems,
• hearing,
• amikacina blood levels, if necessary.

The daily doses will be reduced and/or the time between doses will be extended if signs of kidney problems appear, or if kidney problems worsen. If the kidney problem worsens, treatment with Amikacina Kabi will be discontinued.

Therapy with amikacina will also be suspended if ringing in the ears or hearing loss occurs.

To avoid the risk of kidney damage, nerve damage, and muscle function damage, treatment with Amikacina Kabi will not be extended beyond 10 days unless your doctor considers it necessary.

During treatment, you will be ensured a sufficient fluid supply.

If you undergo any procedure involving washing with solutions containing amikacina or a similar antibiotic in wounds during surgery, this will be taken into account for your amikacina dose.

Children

This medicine will be administered with caution in premature and newborn infants due to the immaturity of the kidneys in these patients.

Other medicines and Amikacina Kabi

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

The harmful effect of Amikacina Kabi on the kidneys and hearing nerve can be increased with the use of the following medicines:

• other antibiotics similar to amikacina;
• other substances used to treat infections such as bacitracin, amphotericin B, penicillin-type antibiotics or cephalosporins, vancomycin, kanamycin, paromomycin, polymyxin B, colistin;
• cancer medicines: high-dose carboplatin, cisplatin, oxaliplatin (especially in cases of existing kidney failure);
• substances that inhibit unwanted immune reactions: cyclosporine, tacrolimus;
• fast-acting medicines that increase urine flow: furosemide or ethacrynic acid. Irreversible deafness may occur;
• bisphosphonates (used to treat osteoporosis and similar diseases)
• thiamine (vitamin B1), as it may lose its effectiveness
• indomethacin (an anti-inflammatory medicine to reduce fever, pain, and joint swelling and stiffness). This may increase the amount of Amikacina Kabi absorbed in newborns.

Administration of these medicines together with or after Amikacina Kabi should be avoided as much as possible.

When Amikacina Kabi is administered in combination with these substances, hearing and kidney function will be carefully and continuously monitored. In cases where Amikacina Kabi is administered together with fast-acting medicines that increase urine flow, fluid balance will be monitored.

Attention should also be paid to the following medicines:

Methoxyflurane anesthesia:

The anesthesiologist should know if you have received or are receiving amikacina or a similar antibiotic before performing methoxyflurane anesthesia (an anesthetic gas), and avoid using this agent whenever possible, as there is a higher risk of severe kidney and nerve damage.

Simultaneous treatment with amikacina and a muscle relaxant (e.g. d-tubocurarine), other agents such as curare, botulinum toxin, or narcotic gases, such as halothane:

In the case of surgery, the anesthesiologist should be informed that you are being treated with amikacina, as there is a risk of worsening nerve and muscle function blockage. In case the aminoglycoside causes muscle and nerve blockage, calcium salts can reverse it.

In newborns receiving Amikacina Kabi, the medicine level in the blood will be carefully monitored if indomethacin is administered simultaneously, as indomethacin can increase the blood level of amikacina.

Other antibiotics:

Combination therapy with suitable antibiotics can significantly enhance the treatment effect.

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.

Pregnancy

If you are pregnant, your doctor will only administer this medicine if it is strictly necessary.

Breastfeeding

Although it is highly unlikely that amikacina will be absorbed through the intestine of breastfed babies, your doctor will decide whether to interrupt breastfeeding or treatment with amikacina.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines.

In the case of administration to outpatients, caution is recommended when driving and using machines due to possible unwanted effects, such as dizziness and vertigo.

Amikacina Kabi contains sodium

This medicine contains 354 mg of sodium (main component of table/cooking salt) per 100 ml. This is equivalent to 17.7% of the maximum recommended daily sodium intake for an adult.

3. How to use Amikacina Kabi

Amikacina Kabi is administered by drip directly into a vein (intravenous infusion). The duration of the infusion can last between 30 and 60 minutes.

Your doctor will determine the suitable dose for you. The following are commonly used doses:

Patients with normal kidney function

Adults and adolescents from 12 years onwards (over 33 kg body weight):

The usual dose is 15 mg of amikacina per kg of body weight every 24 hours, which can be administered in a single dose or divided into 2 equal doses: 7.5 mg per kg of body weight every 12 hours.

At most, you can receive up to 1.5 grams per day for a short period if there is an absolute need for such high doses (e.g. life-threatening infections and/or infections caused by certain bacteria, i.e. pseudomonas, acinetobacter or enterobacteriaceae) and during treatment, you will be properly monitored.

The total amount of amikacina you can receive during the entire treatment will not exceed 15 grams.

Use in infants, children, and adolescents (from 4 weeks to 11 years):

A single daily dose of amikacina of 15-20 mg per kg of body weight or a dose of 7.5 mg per kg of body weight every 12 hours.

Newborns (from 0 to 27 days):

The initial dose is 10 mg of amikacina per kg of body weight, and 12 hours later 7.5 mg of amikacina per kg of body weight. Treatment continues with 7.5 mg of amikacina per kg of body weight every 12 hours.

Preterm infants:

7.5 mg of amikacina per kg of body weight every 12 hours.

Special populations

The daily dose is not recommended in patients with weakened immune systems, kidney failure, cystic fibrosis, ascites, inflammation of the inner lining of the heart, extensive burns (more than 20% of the skin), and during pregnancy.

Patients with kidney problems

If you have kidney failure, the amikacina level in the blood and your kidney function will be carefully and frequently monitored to adjust your amikacina dose accordingly. Your doctor knows how to calculate the doses you will receive.

Patients undergoing hemodialysis or peritoneal dialysis

They receive half the normal dose at the end of the dialysis process.

Older patients

In older patients, kidney function may be reduced. This will be evaluated whenever possible, and your amikacina dose will be adjusted if necessary.

Patients with severe obesity

In these patients, the dose is calculated according to the ideal body weight plus 40% of the excess weight. Later, your dose may be adjusted according to your amikacina blood levels. The maximum dose is 1.5 grams per day. The usual duration of treatment is 7 to 10 days.

Patients with ascites

Higher doses should be administered to achieve adequate medicine levels in the blood.

Treatment duration

Usually, you will receive treatment with amikacina for 7-10 days, only in cases of severe and complicated infections may it be extended for a longer period. Normally, the treatment will show an effect within the next 24 to 48 hours; otherwise, it is possible that your medicine will be modified.

Amikacina levels in the blood will be carefully monitored in all patients, but especially in older patients, newborns, obese individuals, and those with kidney problems or cystic fibrosis, and your dose will be carefully adjusted throughout treatment.

If you receive more Amikacina Kabi than you should

If you think you have been given too much medicine, inform your doctor, nurse, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount received.

An overdose can damage the kidneys and hearing nerve or cause a blockage of muscle function (paralysis). In such a case, the amikacina infusion should be discontinued.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Toxic effects on the hearing nerve and kidneys have been observed in patients treated with Amikacina Kabi. Your doctor can largely avoid these side effects by taking the necessary precautions and administering the doses according to the instructions. Your doctor will monitor your condition to detect any signs of side effects.

If you experience any of the following serious side effects, inform your doctor immediately:

Very rare (may affect up to 1 in 10,000 people)

• swelling of the face, lips, or tongue, skin rash, difficulty breathing, as these may be signs of an allergic reaction
• ringing in the ears or hearing loss (deafness), respiratory paralysis
• kidney problems, including a reduction in urine production (acute kidney failure)

Other side effects:

Uncommon (may affect up to 1 in 100 people)

• dizziness, vertigo
• involuntary eye movements (nistagmus)
• additional infection or colonization (with resistant fungal cells (yeast) called Candida)
• ringing in the ears, ear pressure, hearing problems
• feeling unwell
• damage to certain parts of the kidney, kidney function problems

Rare (may affect up to 1 in 1,000 people)

• abnormally low counts of white or red blood cells or platelets in the blood; increased count of a certain type of white blood cell (eosinophils)
• allergic reactions, skin rash, itching, hives
• low magnesium level in the blood
• headache, migraine, numbness, tremors
• blindness or other vision problems
• low blood pressure
• respiratory depression
• nausea
• joint pain
• drug-related fever
• increased blood levels of certain liver enzymes

Very rare (may affect up to 1 in 10,000 people)

• blockage of muscle function
• severe kidney damage

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

• allergic reactions to substances similar to amikacina (aminoglycosides)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, 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: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amikacina Kabi

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

Do not use this medicine after the expiry date stated on the vial and carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

Shelf life during use (after opening/dilution):

Chemical and physical stability has been demonstrated during use for 24 hours at 25°C and 2-8°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage conditions and times are the responsibility of the user and should not normally exceed 24 hours at 2-8°C, unless the opening/dilution method has been carried out under controlled and validated aseptic conditions.

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

6. Container Content and Additional Information

Composition of Amikacina Kabi

The active ingredient is amikacin.

Each ml of solution for infusion contains 5 mg of amikacin (as sulfate).

Each 50 ml vial of solution contains 250 mg of amikacin.

Each 100 ml vial of solution contains 500 mg of amikacin.

Each 200 ml vial of solution contains 1000 mg of amikacin.

The other components are sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injectable preparations.

Product Appearance and Container Content

Amikacina Kabi is a solution for infusion, i.e., it is administered by dripping through a small tube or cannula placed in a vein.

It is a clear, colorless aqueous solution.

Container sizes: 10 x 50 ml, 10 x 100 ml, and 10 x 200 ml of solution for infusion.

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi España, S.A.U

Marina 16-18

08005 Barcelona

Spain

Manufacturer

Fresenius Kabi Polska Sp. z o.o. ul. Sienkiewicza 25, 99-300 Kutno Poland

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

Date of the Last Revision of this Leaflet:March 2024

Detailed information on this medicinal product 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 only for healthcare professionals:

Incompatibilities

Amikacina Kabi is a ready-to-use formulation and should not be mixed with any other medicinal product (except those mentioned below), but 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 combined pair.

Chemical incompatibilities are known for amphotericin, chlorothiazide, erythromycin, heparin, nitrofurantoin, novobiocin, phenytoin, sulfadiazine, thiopental, chlortetracycline, vitamin B, and vitamin C. Amikacina should not be mixed with these medicinal products beforehand.

Inactivation when mixing aminoglycosides and beta-lactam antibiotics may also persist when taking samples to measure serum antibiotic levels, and, as a consequence, lead to considerable underestimation with dosing errors and toxicity risks. Samples should be handled quickly and placed on ice or beta-lactamase should be added.

Special Precautions for Disposal and Other Handling.

For single use.

Discard any unused solution.

Dilution should be performed under aseptic conditions. The solution should be visually inspected for particles and discoloration before administration. The solution should only be used if the contents are clear and free of particles.

Amikacina Kabi is compatible with the following infusion solutions:

• Ringer's Solution
• Ringer's Lactate Solution
• Sodium Chloride 9 mg/ml (0.9%) injectable solution
• Glucose 5 mg/ml (5%) injectable solution
• Glucose 10 mg/ml (10%) injectable solution

Storage Information

See section 5 "Storage of Amikacina Kabi"

Method of Administration

See section 3 "How to Use Amikacina Kabi"

Posology

See section 3 "How to Use Amikacina Kabi"

Amikacina Kabi is for intravenous infusion only; the infusion duration can last between 30 and 60 minutes.

Infusion Volumes in Patients with Normal Renal Function

The accuracy of dosing is improved if Amikacina Kabi solution for infusion is administered with an infusion pump.

Instructions for Dilution

In pediatric patients, it may be advisable to dilute Amikacina Kabi.

To obtain a concentration of amikacina of 2.5 mg/ml, the respective amount (in ml) of Amikacina 5 mg/ml for the desired dose must be mixed with the same amount of one of the infusion solutions mentioned above.

Pediatric patients should receive an infusion of 1 to 2 hours

Volumes for Infusion of the Diluted Amikacina 2.5 mg/ml Solution:

Treatment of Overdose

In case of overdose or toxic reaction, the infusion of amikacina should be discontinued and forced diuresis applied to accelerate the elimination of amikacina from the blood if necessary. Peritoneal dialysis or hemodialysis may help to remove accumulated amikacina from the blood. Hemodialysis is more effective than peritoneal dialysis in removing amikacina from the blood.

In neonates, the possibility of exchange transfusion may be considered; however, consultation with an expert should be sought before implementing such a measure.

Calcium salts are indicated to neutralize the curare-like effect. Mechanical ventilation may be necessary in respiratory paralysis.