AMIKACIN NORMON 500 mg/2 ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amikacina Normon 500 mg / 2 ml solution for injection and infusion EFG

Amikacina

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Amikacina Normon is and what it is used for
2. What you need to know before you use Amikacina Normon
3. How to use Amikacina Normon
4. Possible side effects
5. Storage of Amikacina Normon
6. Contents of the pack and further information

1. What Amikacina Normon is and what it is used for

Amikacina Normon is an antibiotic of the aminoglycoside group that acts by eliminating bacteria (germs) that cause infections.

It is indicated for the treatment of the following severe, short-term infections:

• Severe generalized infection, also known as sepsis (including neonatal sepsis).
• Severe respiratory tract infections.
• Infection of the central nervous system (including meningitis).
• Intra-abdominal infections (including peritonitis).
• Infections of the skin, bones, soft tissues, and joints.
• Infections in burn patients.
• Infections following surgery (including post-vascular surgery).
• Complicated and recurrent urinary tract infections that cannot be treated with less toxic antibiotics.

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

Do not use Amikacina Normon

• If you are allergic (hypersensitive) to amikacina or any of the other components of this medication (listed in section 6).
• If you have ever had a severe allergic reaction (hypersensitivity) to any other type of aminoglycoside antibiotic.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Amikacina Normon.

• If you or your family members have a mitochondrial mutation 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 can increase your risk of hearing loss with this medication. Your doctor may recommend genetic tests before administering Amikacina Normon.
• If you use this medication, you will be subject to special controls due to the possible toxicity that can affect your ears and kidneys.
• If you have severe muscle disorders, such as myasthenia gravis or Parkinson's disease, as it may increase muscle weakness.

• If you have kidney problems or symptoms of kidney damage appear during treatment, blood and urine tests will be performed to adjust the dose or stop treatment.
• If you have heart disease or other diseases for which you are taking medications that cause fluid retention (medications called diuretics, such as etacrynic acid or furosemide).
• If you experience symptoms of ear toxicity such as dizziness, vertigo, ringing in the ears, and hearing loss.
• You should stay well-hydrated to avoid or minimize kidney damage caused by this medication.

If you need blood or urine tests, Amikacina may cause changes in the analysis values of: urea nitrogen, transaminases, alkaline phosphatase, bilirubin, creatinine, lactate dehydrogenase, sodium, potassium, magnesium, and calcium.

Children and adolescents

Aminoglycosides should be used with caution in premature infants (born before term) and neonates (up to 4 weeks of life) because their kidneys are not fully developed. See section 3 "How to use Amikacina Normon" for the dosage regimen.

Other medications and Amikacina Normon

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

It is not recommended to administer amikacina with the following medications:

• Anesthetics, such as ether, chloroform, medications used in general anesthesia.
• Amphotericin B, a medication used to treat fungal infections.
• Muscle relaxants, such as tubocurarine and pancuronium, used as relaxants in anesthesia.
• Antibiotics, used to treat bacterial infections, such as colistin, polymyxin, piperacillin, clindamycin, and cefalotin.
• Cisplatin, a medication used in cancer treatment.
• Clodronic acid, a medication used to treat bone diseases.
• Loop diuretics, such as etacrynic acid, furosemide, medications used to treat edema and high blood pressure.
• Indomethacin, a non-steroidal anti-inflammatory drug (NSAID), used for pain and inflammation.

You may need additional checks to monitor kidney function while taking amikacina, as these medications can increase the toxicity of amikacina.

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 medication.

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

There is no data on excretion in breast milk. As a general rule, it is recommended that women undergoing treatment with amikacina suspend breastfeeding due to possible adverse reactions in the infant.

Driving and using machines

There is no data available on the effect of Amikacina Normon on the ability to drive or use machines. However, if you experience side effects such as dizziness, vertigo, etc., your ability to drive vehicles or use machines may be impaired. If this happens, do not drive or use any tools or machines.

Amikacina Normon contains sodium metabisulfite and sodium

This medication can cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains metabisulfite (E-223).

This medication contains less than 23 mg (1 mmol) of sodium per dose, so it is considered essentially "sodium-free".

3. How to use Amikacina Normon

Follow exactly the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.Remember to use your medication. Your doctor will indicate the duration of your treatment with amikacina. Do not stop treatment before completion. If you think the action of this medication is too strong or too weak, tell your doctor or pharmacist.

Your doctor will determine the most suitable dose for you based on your age, weight, general condition, severity of the infection, and kidney function.

Your doctor will assess kidney function and monitor it during treatment.

Administration is exclusive to a healthcare professional. It can be administered intramuscularly or intravenously (exclusively by slow intravenous infusion).

Maximum concentrations (30-90 minutes after injection) above 35 µg/ml and minimum concentrations (just before the next dose) above 10 µg/ml should be avoided.

If you use more Amikacina Normon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Amikacina Normon

If you forget to use a dose, use it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed doses.

4. Possible side effects

Like all medications, Amikacina Normon can cause side effects, although not everyone gets them. Amikacina Normon may potentially cause toxicity in the ears and kidneys and neuromuscular blockade. These reactions occur more frequently in patients with previous treatment with medications that cause toxicity in the ears and kidneys and in patients treated for long periods and/or with doses higher than recommended.

The reactions are dose-dependent, frequency-dependent, and duration-dependent. Symptoms may appear during treatment or after completion of treatment.

If you experience any of the following effects, inform your doctor as soon as possible:

Very common (may affect more than 1 in 10 people):

• Neurological toxicity in the ears and muscle paralysis.
• Kidney toxicity.
• Hearing loss and balance disorders.
• Drug fever.

Uncommon (may affect up to 1 in 100 people):

• Nausea, vomiting.
• Headache, tremors.
• Rash.
• Permanent vision loss when amikacina is administered intravitreally (injection into the eye).
• Paresthesia, muscle and joint pain.

Rare (may affect up to 1 in 1000 people):

• Decreased blood pressure.
• Low magnesium levels in the blood.
• Anemia (decreased red blood cells) or eosinophilia (increased white blood cells in the blood).

If you observe any of these reactions or any other reaction not described in this leaflet, consult your doctor or pharmacist.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Amikacina Normon

Store below 25°C. Keep in the original package.

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

Do not use this medication after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This way, you will help protect the environment.

6. Container Content and Additional Information

Composition of Amikacina Normon

• The active ingredient is amikacina (as sulfate). Each vial (2 ml) contains 500 mg of amikacina (as sulfate). Each ml contains 250 mg of amikacina (as sulfate).
• The other components (excipients) are: sodium metabisulfite (E-223), sodium citrate, sulfuric acid (pH adjuster), and water for injectable preparations.

Appearance of the Product and Container Content

Amikacina Normon is presented in type I glass vials closed with a butyl rubber stopper and sealed with an aluminum cap. Transparent injectable solution in 2 ml vials.

The unit containers contain 1 vial and the clinical containers 50 vials.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Date of the Last Revision of this Prospectus:June 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended solely for healthcare professionals

It is administered by intramuscular and intravenous route (exclusively slow intravenous perfusion, 30-60 minutes).

It should be visually inspected for possible presence of particles and/or discoloration before administration, whenever the solution and container allow it. It should be reconstituted before use.

In intravenous administration, (exclusively intravenous perfusion), the vial should be reconstituted. The solution is prepared by adding 100 ml or 200 ml of sterile diluent, such as saline solution or 5% glucose in water or another compatible solution, to the required dose. The reconstituted solution is a clear and colorless solution. Occasionally, the solution may present a pale yellow coloration that does not indicate any alteration of the medication.

The chemical and physical stability in use of amikacina solutions in concentrations of 0.25 mg/ml and 5 mg/ml in 0.9% sodium chloride or in a concentration of 0.25 mg/ml in Ringer's lactate solution has been demonstrated for 24 hours if the product is stored below 25°C.

From a microbiological point of view, the diluted product should be used immediately. If it is not used immediately, the storage times and conditions before administration are the responsibility of the user and should not normally exceed 24 hours below 25°C.

Amikacina should not be physically mixed with other medications, but it can be administered independently according to the recommended dose and route.

Administration in adults and children over 12 years:

The recommended intramuscular or intravenous dose (slow intravenous perfusion) for adults is 15 mg/kg/day, divided into 2 or 3 equal doses administered at equivalent intervals, i.e., 7.5 mg/kg every 12 hours or 5 mg/kg every 8 hours. Treatment in patients with high body mass should not exceed 1.5 grams/day.

Single daily dose

In patients with normal renal function reflected by a creatinine clearance ≥ 50 ml/min, a single daily intravenous dose (slow intravenous perfusion) of 15 mg/kg/day can be administered in adults, in the treatment of bacteremia, sepsis, respiratory tract infections, complicated urinary tract infections, intra-abdominal infections, and in cases of febrile neutropenia. There is no sufficient information available on the use of a single daily dose in patients with impairment of other organs or systems.

Administration of normal doses at prolonged intervals:

If the creatinine clearance rate is not available, and the patient's conditions are stable, the dosing interval for a normal dose (the same as that administered to patients with normal renal function, 7.5 mg/kg twice a day) can be calculated by multiplying the patient's serum creatinine value by 9. For example, if the patient has a serum creatinine concentration of 2 mg/100 ml, the recommended single dose (7.5 mg/kg) should be administered every 18 hours.

Patient with impaired renal function

Administration of reduced doses at fixed time intervals:

When renal function is impaired and it is convenient to administer this medication at fixed time intervals, the dose should be reduced.

First, treatment is initiated by administering a normal dose of 7.5 mg/kg as a loading dose. This dose is the same as that administered to a patient with normal renal function. To determine the maintenance doses administered every 12 hours, the loading dose should be reduced in proportion to the reduction in the patient's creatinine clearance rate.

In patients with demonstrated renal insufficiency reflected by a creatinine clearance <50 ml min, it is not recommended to administer the total daily dose in a single administration, as patients would be exposed high serum concentrations. with renal insufficiency who receive doses 2 or 3 times day, amikacina concentrations should monitored by appropriate analytical procedures. can adjusted either administering normal at prolonged intervals reduced fixed intervals.< p>

Administration in patients over 65 years:

The recommended dose, intramuscular or intravenous, is 15 mg/kg/day, divided into 2 or 3 equal doses administered at equivalent intervals, i.e., 7.5 mg/kg every 12 hours or 5 mg/kg every 8 hours (see section 4.4)

Pediatric Population

Administration in children under 12 years:

The recommended intramuscular or intravenous dose (slow intravenous perfusion) in children is 15 mg/kg/day, which can be administered: 15 mg/kg, once a day; 7.5 mg/kg, twice a day; or 5 mg/kg, three times a day.

Administration in infants and newborns:

The recommended dose in preterm infants is 7.5 mg/kg every 12 hours. In newborns, a loading dose of 10 mg/kg should be administered, followed by 7.5 mg/kg every 12 hours. Children over 2 weeks should receive 7.5 mg/kg every 12 hours or 5 mg/kg every 8 hours.

Caution should be exercised when calculating exact doses, and when necessary, the reconstituted solution of 50 mg/ml should be further diluted to allow administration in premature neonates.

Single daily dose:A single daily intravenous dose of 20 mg/kg/day can be administered in children 4 weeks of age or older for the treatment of bacteremia, sepsis, respiratory tract infections, complicated urinary tract infections, intra-abdominal infections, and in cases of febrile neutropenia.