AMIKACINA 5 mg /Ml Infusion Solution

Зміст інструкції

1. Amikacina B. Braun 2.5 mg/ml solution for infusion, 5 mg/ml solution for infusion, 10 mg/ml solution for infusion
   1. What is Amikacina B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml and what is it used for
   2. What you need to know before you are given Amikacina B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml
   3. How Amikacin B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml is administered
   4. Possible side effects
   5. How to store Amikacina B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml
   6. Other information

Amikacina B. Braun 2.5 mg/ml solution for infusion, 5 mg/ml solution for infusion, 10 mg/ml solution for infusion

Amikacina

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Amikacina B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml is and what it is used for;
• 2. What you need to know before you are given Amikacina B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml;
• 3. How to use Amikacina B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml;
• 4. Possible side effects;
• 5. How to store Amikacina B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml;
• 6. Contents of the pack and other information.

1. What is Amikacina B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml and what is it used for

Amikacina B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml belongs to a group of medicines called
antibiotics, meaning it is used to treat serious infections caused by bacteria that can be killed by the
active substance amikacin. Amikacin belongs to a group of substances called aminoglycosides.
Amikacin may be administered to you for the treatment of the following diseases:

• Infections of the lungs and lower airways that occur during hospital treatment, including severe pneumonia.
• Infections within the abdomen, including inflammation of the peritoneum.
• Complicated and recurrent infections of the kidneys, urinary tracts and bladder.
• Infections of the skin and soft tissues, including severe burns.
• Bacterial inflammation of the inner lining of the heart.
• Infections following abdominal surgery.
• Amikacina 2.5 mg/ml, 5 mg/ml, 10 mg/ml can also be used in the treatment of patients with inflammation of the whole body that occurs in association with any of the infections listed, or of which an association is suspected.

2. What you need to know before you are given Amikacina B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml

Do not take Amikacina B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml

• if you are allergic (hypersensitive) to amikacin, to other similar substances (other aminoglycosides) or to any of the other ingredients of this medicine;

Warnings and precautions
Talk to your doctor before taking Amikacina B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml.
Particular caution should be exercised with Amikacina B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml if:

• you suffer from impaired kidney function,
• you suffer from impaired hearing,
• you suffer from nervous and muscular diseases, such as a particular type of muscle weakness called myasthenia gravis
• you suffer from Parkinson's disease,
• you have already been treated with another antibiotic similar to amikacin. In all these cases, your doctor must be particularly careful.

If you suffer from any of the following conditions, you may be at higher risk of developing harmful effects
to your hearing or your nerves:

• impaired kidney function
• advanced age (≥ 60 years)
• dehydration
• administration of high doses of this medicine
• prolonged therapy for more than 5-7 days, even in healthy patients.

The first signs of harmful effects to your hearing or your nerves after taking this medicine
may be:

• problems hearing high-pitched sounds (high-frequency hearing loss)
• dizziness
• numbness, skin tingling, muscle spasms, convulsions.

After the administration of this medicine, breathing (respiratory paralysis) and muscle and nerve functions (neuromuscular block) may be blocked. Your doctor will take appropriate countermeasures.

Elderly patients
If you are an elderly patient, your doctor will pay particular attention to your kidney function, and may conduct several tests to make sure that your kidneys are not impaired, as
elderly patients are more likely to have impaired kidney function.

Paediatric population
Caution is also required when administering the medicine to newborns or premature infants due to
immature kidney function.
During therapy with this medicine, the doctor will keep you under close observation, paying
particular attention to your hearing ability and kidney function.
The observation will involve

• kidney function, especially if you have kidney failure or signs indicating its onset during treatment;
• hearing and amikacin levels in the blood, if necessary.

If signs of kidney damage appear or if kidney damage worsens, the doctor will reduce daily doses
and/or lengthen the intervals between administrations. If kidney damage becomes severe, amikacin will
be discontinued.
Therapy with amikacin must also be discontinued if you experience ringing in the ears or
observe hearing loss.
If you undergo wound irrigation procedures with solutions
containing amikacin or a similar antibiotic during surgery, this must be taken into account for dosage
of amikacin.

Other medicines and Amikacina B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml
Tell your doctor if you are taking, have recently taken or may take any other
medicines.
The harmful effect of amikacin on the kidneys and auditory nerve may be strengthened by:

• other antibiotics similar to amikacin (e.g. kanamycin, paromomycin);
• other substances used to treat infections, such as bacitracin, amphotericin B, cephalosporin, vancomycin, polymyxins (polymyxin B, colistin) viomycin;
• anticancer drugs: carboplatin (at high doses), cisplatin, oxaliplatin (especially in case of pre-existing kidney failure);
• substances that suppress undesirable immune reactions: cyclosporine, tacrolimus;
• substances that rapidly increase urine flow: furosemide or ethacrylic acid (can damage hearing because water body deficit determines a high concentration of amikacin).
• Anesthesia with methoxyflurane: the anesthesiologist must know if you have taken or are taking amikacin or a similar antibiotic before performing anesthesia with methoxyflurane (an anesthetic gas) and, as far as possible, must avoid using this agent, due to a greater risk of serious damage to kidneys and nerves.

When it is necessary to combine amikacin with such substances, monitoring of hearing and
kidney function must be very frequent and rigorous. If you use amikacin together with
medicines that increase urine flow, rapidly, you must keep the water balance under observation.

Concomitant treatment with amikacin and muscle relaxants, other substances with effects on

muscles and nerves
Your doctor will pay particular attention if you receive amikacin in association with muscle
relaxants (such as succinylcholine, decamethonium, atracurium, rocuronium, vecuronium), a large
amount of blood treated to prevent coagulation (citrated blood) or anesthetics: breathing may
undergo a block (respiratory paralysis).
On the occasion of a surgical intervention, the anesthesiologist must be informed of the ongoing treatment
with amikacin, due to the risk of strengthening the block of nerve and muscle functions.
If the aminoglycoside causes a nervous and muscular block, it can be neutralized with calcium
salts.

Indometacin
In newborns receiving amikacin and indometacin (a medicine against
inflammation and pain) at the same time, the amikacin blood level must be carefully monitored.
Indometacin can increase the level of amikacin in the blood.

Bisphosphonates
Combined therapy with bisphosphonates (used to treat osteoporosis and similar diseases) has a high
risk of lowering blood calcium levels (hypocalcemia).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before taking this medicine.

Pregnancy
You will receive this medicine only if absolutely necessary.

Breastfeeding
Although it is rather unlikely that amikacin is absorbed through the intestine by breastfed babies, the doctor will carefully assess whether to discontinue breastfeeding or therapy with
amikacin.

Fertility
Studies in animals have not shown any effect on fertility.

Driving and operating machinery
Studies on the ability to drive vehicles and operate machinery have not been conducted. If
administered to outpatients, caution is advised when driving vehicles and operating machinery, considering possible adverse effects such as dizziness and vertigo.

Important information about some excipients of Amikacina B. Braun 2.5 mg/ml, 5 mg/ml,
10 mg/ml
This medicine contains 354 mg (or 15 mmol) of sodium per 100 ml in the form of common salt; it
is necessary to take this into account in patients following a low-sodium diet.

3. How Amikacin B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml is administered

Amikacin B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml is administered via an intravenous drip directly into a vein
(intravenous infusion). The contents of one vial are administered over 30-60 minutes.
The doctor will determine the correct dose for you. Usually, the following doses are used:

Dosage in patients with normal kidney function

• Adults and adolescents over 12 years of age (weighing more than 33 kg): The usual dose is 15 mg of amikacin per kg of body weight (BW) per 24 hours, divided into 2 identical doses: 7.5 mg per kg of BW every 12 hours. A maximum of 1.5 grams per kg of BW per day may be administered for a short period, if such high doses are absolutely necessary; in this case, rigorous and constant monitoring will be carried out during treatment. The total amount of amikacin that you can receive during the entire treatment must not exceed 15 grams.
• Infants, toddlers and children: A single daily dose of 15-20 mg/kg of amikacin or a dose of 7.5 mg/kg every 12 hours.
• Dosage for newborns: The initial dose is 10 mg of amikacin per kg of BW, and 12 hours later 7.5 mg of amikacin per kg of BW. Treatment continues with 7.5 mg of amikacin per kg of BW every 12 hours.
• Dosage for premature babies: 7.5 mg of amikacin per kg of BW every 12 hours.

However, this does not apply to patients with a weakened immune system, kidney failure,
cystic fibrosis, fluid in the abdomen, inflammation of the inner lining of the heart,
extensive burns (more than 20 percent of the skin surface), elderly patients and pregnant women.

Duration of treatment
Usually, treatment with amikacin will be administered for 7–10 days, and only in cases of severe and complicated infections for a longer period. The effect of therapy will usually manifest within 24-48
hours, otherwise it may be necessary to switch to another medicine. In this case, the doctor will assess your
condition and reconsider the treatment.
Careful monitoring of amikacin levels in the blood and dosage adjustment will be required throughout therapy.

Dosage in patients with impaired kidney function
If your kidney function is impaired, your amikacin levels in your blood and your kidney function
must be checked carefully and frequently, in order to correct the amikacin dose
as needed. The doctor knows how to calculate the doses you need to receive.
In patients undergoing hemodialysis or peritoneal dialysis, it may be necessary to administer a
modified dose of amikacin. In this case, the doctor will determine the correct dose for you.
Elderly patients.
Lower doses of amikacin than those for younger patients may be necessary in elderly patients to achieve therapeutic concentrations in plasma. Whenever possible, your kidney function will be assessed and, if necessary, the dose you receive will be modified.

Severely overweight patients
In these patients, the dosage is calculated based on ideal body weight, adding 40% of the
excess weight. Subsequently, the dosage can be adjusted based on amikacin levels in the
blood. The doctor will not administer more than 1.5 g of amikacin per day.
The usual duration of treatment is between 7 and 10 days.

Patients with fluid in the abdomen
Higher doses are needed to achieve adequate levels in the blood.

If you are given more Amikacin B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml than you should
Overdosage can damage the kidneys and nerves of the ear or cause a blockage of muscle function (paralysis). In this case, the amikacin infusion must be stopped and procedures to remove the medicine from the blood can be started (dialysis, hemofiltration). In newborns, a blood transfusion may
be considered; however, expert advice should be sought before taking such action.
In case of muscle and nerve blockage accompanied by respiratory blockage, the doctor will administer the necessary treatment. Calcium salts (e.g. gluconate or lactobionate in 10 to 20% solution) can be used to cancel the paralyzing effect. Mechanical ventilation may be necessary in respiratory paralysis.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Amikacina B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml can cause side effects, although not everybody gets them.
Amikacin and all other similar substances can show toxic effects on the auditory nerve, kidneys and
cause a muscle and nerve block. These effects are observed more often in patients

• who suffer from kidney problems,
• treated with other medicines that have a harmful effect also on the auditory nerve and kidneys,
• who receive a dosage that is too high or a prolonged treatment.

The adverse reactions that may be caused by the treatment are listed below according to their
absolute frequency.
The following adverse reactions can be serious and require immediate treatment:

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

• blockage of breathing (respiratory paralysis)

Not known (frequency cannot be estimated from available data)

• allergic reactions up to and including shock;
• deafness (irreversible);
• acute renal failure, kidney damage;
• paralysis.

Other side effects are:

Uncommon (may affect up to 1 in 100 people)

• Further infection or condition with resistant microbes.
• Dizziness, vertigo.
• Nausea, vomiting.
• Damage to certain parts of the kidney (renal tubules).
• Rash.

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

• Anemia, increased count of a certain type of white blood cells (eosinophils).
• Itching, hives.
• Low level of magnesium in the blood.
• Headache, numbness, tremors, loss of balance.
• Low blood pressure.
• Joint pain, uncontrolled muscle movements.
• Decreased diuresis, presence of albumin, white blood cells and/or red blood cells in the urine.
• Increased level of compounds containing creatinine and/or nitrogen in the blood (oliguria, azotemia).
• Drug-related fever.
• Blindness or other vision problems*
• Ringing in the ears (tinnitus), mild deafness (hypoacusis).

*This medicine is not made to be used in the eye. Following the injection of this
medicine into the eye, blindness and retinal infarction have been reported.

Not known (frequency cannot be estimated from available data):

• cells in the urine.
• cessation of breathing, difficulty breathing (bronchospasm).

Reporting of suspected adverse reactions
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through
the national reporting system at www.agenziafarmaco.gov.it/it/responsabili . Reporting side effects helps to provide more information on the safety of
this medicine.

5. How to store Amikacina B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml

Keep this medicine out of the sight and reach of children.
Do not use Amikacina B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml after the expiry date which is reported
on the vial and the outer packaging. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
The infusion solution must be used immediately.
Single use.
Discard any unused solution.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Other information

What contains Amikacina B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml
The active ingredient is:
amikacin.
1 ml of Amikacina B. Braun 2.5 mg/ml solution for infusion contains 2.5 mg of amikacin,
as amikacin sulfate.
1 bottle of 100 ml contains 250 mg of amikacin.
1 ml of Amikacina B. Braun 5 mg/ml solution for infusion contains 5 mg of amikacin, as
amikacin sulfate.
1 bottle of 100 ml contains 500 mg of amikacin.
1 ml of Amikacina B. Braun 10 mg/ml solution for infusion contains 10 mg of amikacin,
as amikacin sulfate.
1 bottle of 100 ml contains 1000 mg of amikacin.

• The other components are:
• sodium chloride, sodium hydroxide (for pH correction), water for injections.

Description of the appearance of Amikacina B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml and contents of the
pack
Amikacina B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml is an aqueous solution, clear and colorless, for
infusion;
It is contained in 100 ml polyethylene bottles.
It is supplied in packs of 10 and 20 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder

• B. Braun Melsungen AG Carl-Braun strasse, 1 34212 Melsungen Germany

Manufacturer

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

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
AustriaAmikacin B. Braun 2.5 mg/ml Infusionslösung;
Amikacin B. Braun 5 mg/ml Infusionslösung;

BelgiumAmikacine B. Braun 2.5 mg/ml Solution pour perfusion,
Oplossing voor infusie, Infusionslösung;
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

BulgariaАмикацин Б. Браун 2,5 mg/ml инфузионен разтвор
Амикацин Б. Браун 5 mg/ml инфузионен разтвор
Амикацин Б. Браун 10 mg/ml инфузионен разтвор

Czech RepublicAmikacin B. Braun 5 mg/ml
Amikacin B. Braun 10 mg/ml

GermanyAmikacin B. Braun 2.5 mg/ml Infusionslösung
Amikacin B. Braun 5 mg/ml Infusionslösung
Amikacin B. Braun 10 mg/ml Infusionslösung

EstoniaAmikacin B. Braun 5 mg/ml
Amikacin B. Braun 10 mg/ml

GreeceAmikacin B. Braun 2.5 mg/ml διάλυμα για έγχυση
Amikacin B. Braun 5 mg/ml διάλυμα για έγχυση
Amikacin B. Braun 10 mg/ml διάλυμα για έγχυση

FranceAMIKACINE 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

HungaryAmikacin B. Braun 5 mg/ml oldatos infúzió;
Amikacin B. Braun 10 mg/ml oldatos infúzió

ItalyAmikacina B. Braun 2.5 mg/ml soluzione per infusione
Amikacina B. Braun 5 mg/ml soluzione per infusione
Amikacina B. Braun 10 mg/ml soluzione per infusione

LuxembourgAmikacin B. Braun 2.5 mg/ml Infusionslösung;
Amikacin B. Braun 5 mg/ml Infusionslösung;
Amikacin B. Braun 10 mg/ml Infusionslösung

LatviaAmikacin B. Braun 5 mg/ml šķīdums infūzijām;
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The following information is only for doctors or healthcare professionals:
Additional warnings:
Neuro/ototoxicity
During therapy, patients who develop cochlear or vestibular damage may not
experience symptoms indicating the development of toxicity to the eighth nerve and may
develop bilateral, partial or total irreversible hearing loss, or disabling vertigo after
discontinuation of the medicine.
Toxic effects on the eighth cranial nerve can result in hearing loss, loss of
balance, or both. Amikacin primarily affects auditory function. Cochlear damage
includes high-frequency hearing loss and usually occurs before clinical hearing loss can
be detected by audiometric tests.
Aminoglycoside-induced ototoxicity is generally irreversible.
Neuromuscular toxicity
The possibility of respiratory paralysis must be considered if aminoglycosides are
administered by any route, especially in patients receiving medicines that induce
neuromuscular blockade concomitantly. If neuromuscular blockade occurs, calcium salts may reverse
respiratory paralysis, but mechanical respiratory support may be necessary. Neuromuscular
blockade and muscle paralysis have been demonstrated in laboratory animals that received high doses of
amikacin.
Interference with laboratory tests
Serum creatinine levels may provide falsely elevated values when
cephalosporins are administered concomitantly.
The mutual inactivation of amikacin and beta-lactam antibiotics can continue in samples
(e.g. serum, cerebrospinal fluid, etc.) taken for aminoglycoside dosage, leading in this way to erroneous
results. Therefore, samples should be analyzed immediately after
discontinuation or they should be refrigerated, or the beta-lactam antibiotic should be inactivated
by adding beta-lactamase. Inactivation of the aminoglycoside is clinically significant only in
patients with severely impaired renal function.

Patient monitoring
Renal and eighth cranial nerve function should be monitored as closely as
possible in patients with known or suspected renal insufficiency at the start of therapy, and also in those whose
renal function is initially normal but who develop signs of renal dysfunction during
therapy. When possible, serum concentrations of amikacin should be monitored to
ensure adequate levels and to avoid potentially toxic levels. Urine should be analyzed

for a reduced specific gravity, increased protein excretion, and the presence of cells or cylinders.
Blood urea nitrogen, serum creatinine, or creatinine clearanceshould be measured
periodically. When possible, serial audiograms should be obtained in patients who
are old enough to be tested, particularly in high-risk patients. Evidence of
ototoxicity (dizziness, vertigo, tinnitus, ringing in the ears, and hearing loss) or nephrotoxicity
requires discontinuation of the medicine or dosage adjustment.
Incompatibilities
Amikacina B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml are ready-to-use formulations and must not
be mixed with any other medicine, but administered separately, in accordance with the recommended dose
and route of administration.
Under no circumstances should aminoglycosides be mixed in an infusion solution with beta-lactam
antibiotics (e.g. penicillins, cephalosporins), due to the risk of causing physicochemical inactivation
of the associated antibiotic.
Chemical incompatibilities are known for amphotericin, chlorothiazides, erythromycin, heparin,
nitrofurantoin, novobiocin, phenytoin, sulfadiazine, thiopental, chlorotetracycline, vitamin B and
vitamin C. Amikacin should not be pre-mixed with these medicines.
The inactivation induced by mixing aminoglycosides and beta-lactams can persist even in
blood samples taken to measure antibiotic levels, inducing a considerable
underestimation with the consequence of dosage errors and risks of toxicity. Samples must be handled
quickly and placed on ice or beta-lactamase added.
Shelf life

Before opening:
3 years.

Shelf life in use (after opening):
From a microbiological point of view, the product must be used immediately. If not used
immediately, the user is responsible for the storage times in use and the conditions
prior to use, which usually should not exceed 24 hours at a temperature of 2-8°C.

Posology
Infusion volumes in patients with normal renal function:

Administering the Amikacina B. Braun 2.5 mg/ml, 5 mg/ml, 10 mg/ml infusion solution
with an infusion pump improves the accuracy of the dosage.
This formulation is for single use only, is ready to use and must not be diluted before
administration.
To avoid overdose, especially in children, the most suitable concentration should be chosen from
those available.

Patients with impaired renal function (clearanceof creatinine < 50 ml/min)

Note: the administration of amikacin once a day is not recommended in patients with
renal dysfunction ( clearanceof creatinine < 50 ml/min).
In case of impaired renal function with a glomerular filtration rate of less than
70 ml/minute, it is recommended to reduce the doses or prolong the dosing intervals, because accumulation of
amikacin is likely. In patients with impaired renal function, the loading dose of
amikacin is 7.5 mg/kg of body weight. The dosing interval for individual patients is
calculated as 9 times the serum creatinine level. For example, if the concentration of
creatinine is 2 mg/100 ml, the recommended individual dose (7.5 mg/kg of body weight) should
be administered every 2 x 9 = 18 hours.
For patients with chronic renal failure and known creatinine clearance, the maintenance dose
administered at 12-hour intervals is calculated using the formula:
( clearanceof creatinine of the patient in ml/minute ÷ normal value of clearanceof creatinine in
ml/minute) x amikacin 7.5 mg/kg of body weight.
The values presented in the following table can be used as a guide

Clearance
Amikacin dose for 12 hours
of for a patient weighing 70 kg
creatinine Daily amikacin dose body
[ml/min] [mg/kg of body weight per day] [mg]

• 70 – 80 7.6 – 8 266 – 280
• 60 – 69 6.4 – 7.6 224 – 266
• 50 – 59 5.4 – 6.4 186 – 224
• 40 – 49 4.2 – 5.4 147 – 186
• 30 – 39 3.2 – 4.2 112 – 147
• 20 – 29 2.1 – 3.1 77 – 112
• 15 – 19 1.6 – 2.0 56 – 77

For complete information on this medicine, please refer to the summary of product characteristics.