PATIENT INFORMATION LEAFLET

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

Amikacina

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before using Amikacina Normon

3. How to use Amikacina Normon

4. Possible side effects

5. Storage of Amikacina Normon

6. Contents of the pack and additional information

Amikacina Normon is an antibiotic from 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, known as sepsis (including neonatal sepsis).
• Severe respiratory tract infections.
• Central nervous system infections (including meningitis).
• Intra-abdominal infections (including peritonitis).
• Skin, bone, soft tissue, and joint infections.
• Burn infections.
• Surgical site infections (including post-vascular surgery).
• Complicated and recurrent urinary tract infections that cannot be treated with less toxic antibiotics.

No use Amikacina Normon

• If you are allergic (hypersensitive) to amikacin 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 disease (a genetic disorder) 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 administration of Amikacina Normon.
• If you use this medication, you will be subject to special controls due to the possible toxicity that may affect the 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 failure or symptoms of renal impairment during treatment, blood and urine analyses will be performed to adjust the dose or discontinue 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 symptoms of ototoxicity such as dizziness, vertigo, ringing in the ears, and hearing loss appear.
• You must remain well-hydrated to avoid or minimize kidney damage caused by this medication.

Amikacina may cause alterations in blood and urine analysis values: 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 time) and neonates (with 4 weeks of life) because the kidneys are not fully formed.See later, section 3 "How to use Amikacina Normon", for the dosing schedule.

Other medications and Amikacina Normon

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

Do not recommend the administration of amikacin with the following medications:

• Anesthetics, such as ether, chloroform, medications used in general anesthesia.
• Amphotericin B, 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 cephalothin.
• Cisplatin, medication used in cancer treatment.
• Chlorodronic acid, medication used to treat bone diseases.
• Diuretics of the loop, such as etacrynic acid, furosemide, medications used to treat edema and high blood pressure.
• Indomethacin, non-steroidal anti-inflammatory drug (NSAID), used for pain and inflammation.

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

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

This medication is not recommended during pregnancy, although your doctor will evaluate the need for 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. As a general rule, women taking amikacina are advised to suspend breastfeeding due to possible adverse reactions to the infant.

Driving and operating machinery

No data are available on the effect of Amikacina Normon on the ability to drive or operate machinery. However, if you experience adverse reactions such as dizziness, vertigo, etc., your ability to drive vehicles or operate machinery may be impaired. If this occurs, do not drive or use any tools or machinery.

Amikacina Normon contains sodium metabisulfite and sodium

This medication may cause severe allergic reactions and bronchospasm (sudden sensation of choking) 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".

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.Remember to use your medication. Your doctor will inform you of the duration of your treatment with amikacina. Do not discontinue treatment prematurely. If you estimate that the effect of this medication is too strong or too weak, inform 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 establish the state of renal function and should perform a follow-up of renal function during treatment.

Administration exclusively by a healthcare professional.It can be administered via intramuscular or intravenous route (exclusively by slow intravenous infusion).

Concentrations above 35 µg/ml (30-90 minutes after injection) and below 10 µg/ml (just before the next dose) 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Amikacina Normon

If you forget to use a dose, use it as soon as you remember. However, if there is little time left for the next dose, skip the missed dose. Do not receive a double dose to compensate for missed doses.

Like all medications, Amikacina Normon may produce adverse effects, although not everyone will experience them. Amikacina Normon may potentially induce a risk of toxicity in the ears and kidneys and neuromuscular blockade. These reactions occur more frequently in patients previously treated with medications that produce ear and kidney toxicity and in patients treated for long periods and/or with doses higher than those recommended.

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

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

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

• Neurological toxicity in the ears and muscle paralysis.
• Kidney toxicity.
• Loss of hearing and balance.
• Drug fever.

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

• Nausea, vomiting.
• Headache, tremors.
• Skin rash.
• Permanent infarction with loss of vision when administered intravitreally (injection into the eye).
• Paresthesias, 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 prospectus, consult your doctor or pharmacist.

Reporting Adverse Effects:

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

Store below 25°C. Store in the original packaging.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Amikacin Normon

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

Aspect of the product and content of the package

Amikacin Normon is presented in glass vials type I closed with a rubber-bulb stopper and sealed with an aluminum capsule. Transparent injectable solution in vials of 2 ml.

Unit packages contain 1 vial and clinical packages 50 vials.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Last review date of this leaflet:June 2023

This information is intended solely for healthcare professionals

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

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

In intravenous administration, (exclusively slow intravenous infusion), the vial should be reconstituted. The solution is prepared by adding to the required dose 100 ml or 200 ml of sterile diluent, such as saline solution or 5% glucose in water or other compatible solution. The reconstituted solution is a transparent and colorless solution. In some cases, the solution may present a pale yellow color that does not indicate any alteration of the medicine.

The chemical and physical stability in use of amikacin solutions in concentrations of 0.25 mg/ml and 5 mg/ml in sodium chloride 0.9% or in 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 not used immediately, the storage times and conditions in use, prior to administration, are the responsibility of the user and should not normally exceed 24 hours below 25°C.

Amikacin should not be physically mixed with other medicines, but it may be administered independently according to the recommended dose and route.

Administration in adults and children over 12 years:

The recommended intramuscular or intravenous (slow intravenous infusion) dose 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 h or 5 mg/kg every 8 h. The treatment in patients with a large body mass should not exceed 1.5 grams/day.

Single daily dose

In patients with normal renal function reflected by a creatinine clearance of 50 ml/min, a single daily intravenous (slow intravenous infusion) dose of 15 mg/kg/day in adults may be administered for 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 between doses:

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 would be administered to patients with normal renal function, i.e. 7.5 mg/kg twice a day) may be calculated by multiplying the patient's serum creatinine concentration 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.

Patients with renal impairment

Administration of reduced doses with fixed time intervals between doses:

When renal function is impaired and it is desirable to administer this medicine 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 would be 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 of <50

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 h or 5 mg/kg every 8 h (see section 4.4)

Pediatric population

Administration in children under 12 years:

The recommended intramuscular or intravenous (slow intravenous infusion) dose in children is 15 mg/kg/day, which may 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 neonates and newborns:

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

Care should be taken to calculate the exact doses and, when necessary, the reconstituted solution of 50 mg/ml should be diluted further to allow administration in neonates.

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