GENTAMYCIN 40 mg /Ml Solution

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Gentamycin Krka, 40 mg/ml, solution for injection and infusion
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Gentamycin Krka and what is it used for
   1. When is Gentamycin Krka used
4. Important information before using Gentamycin Krka
   1. When not to use Gentamycin Krka
   2. Warnings and precautions
   3. Gentamycin Krka and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Gentamycin Krka contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216).
   7. Gentamycin Krka contains sodium metabisulfite (E 223).
   8. Gentamycin Krka contains sodium.
5. How to use Gentamycin Krka
   1. Dosage
   2. Method of administration
   3. Using a higher dose of Gentamycin Krka than recommended
   4. Missing a dose of Gentamycin Krka
   5. Stopping treatment with Gentamycin Krka
6. Possible side effects
   1. If you experience any of the following side effects, tell your doctor immediately.
   2. Reporting side effects
7. How to store Gentamycin Krka
8. Contents of the pack and other information
   1. What Gentamycin Krka contains
   2. What Gentamycin Krka looks like and contents of the pack
   3. Marketing authorisation holder and manufacturer
   4. Information intended for healthcare professionals only: Dosage in patients with renal impairment

Leaflet attached to the packaging: patient information

Gentamycin Krka, 40 mg/ml, solution for injection and infusion

Gentamicin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Gentamycin Krka and what is it used for

Gentamycin Krka is an antibiotic belonging to the aminoglycoside group. It kills bacteria that cause severe infections of the body.

When is Gentamycin Krka used

Gentamycin Krka is used to treat severe infections caused by Gram-negative aerobic bacteria sensitive to its action. These infections include:

• septicaemia and other severe systemic infections,
• infections in the abdominal cavity: peritonitis, abscesses, cholangitis (the drug is usually administered with metronidazole or clindamycin),
• urinary tract infections,
• respiratory tract infections,
• secondary infections of burns and post-traumatic and post-operative wounds,
• severe infections in newborns.

2. Important information before using Gentamycin Krka

When not to use Gentamycin Krka

• if you are allergic to gentamicin, other aminoglycoside antibiotics or any of the other ingredients of this medicine (listed in section 6),
• if you have a disease called myasthenia (muscle weakness).

Warnings and precautions

If you have any chronic disease, have metabolic disorders, are hypersensitive (allergic) to other medicines or are taking other medicines, you should tell your doctor before starting to take Gentamycin Krka.
You should also inform your doctor if:

• you have hearing or balance disorders, Parkinson's disease or have had any kidney disease in the past,
• you have low calcium levels in the blood (hypocalcaemia),
• after starting treatment, you experience hearing disorders, dizziness or ringing in the ears,
• you have severe diarrhoea.

If you experience severe or prolonged diarrhoea associated with gentamicin treatment, you should immediately consult your doctor, who will determine whether it is not a life-threatening complication called pseudomembranous colitis

• that may require appropriate treatment. If you experience diarrhoea during gentamicin treatment, do not take any medicines that slow down bowel movements (peristalsis).

During treatment with Gentamycin Krka, symptoms of hearing disorders, especially in children, the elderly, patients with kidney function disorders, patients who have previously had such disorders, patients treated with other ototoxic medicines, those who are not sufficiently hydrated or treated with higher doses of gentamicin for a longer period, may occur. Your doctor will closely monitor your condition during treatment to prevent hearing damage.
He or she may examine your hearing, balance, kidney function and gentamicin levels in the blood.
If you or your mother have a history of a mitochondrial mutation (a genetic disease) or hearing loss caused by the use of antibiotic medicines, you should inform your doctor or pharmacist before taking an aminoglycoside; some mitochondrial mutations may increase the risk of hearing loss after taking this medicine. Before administering Gentamycin Krka, your doctor may recommend genetic testing.
Gentamicin may cause kidney function disorders. This is more common in patients taking high doses of gentamicin, the elderly, women, patients with pre-existing kidney function disorders, those who are not sufficiently hydrated, patients with nephrotic syndrome, patients with diabetic nephropathy and patients treated with other nephrotoxic medicines.

Gentamycin Krka and other medicines

Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
When Gentamycin Krka is used together with other medicines, the risk of side effects increases. You should inform your doctor if you are taking any of the following medicines:

• diuretics (especially ethacrynic acid and furosemide),
• succinylcholine, tubocurarine, botulinum toxin (muscle relaxants),
• certain antibiotics (amikacin, tobramycin, vancomycin, cephaloridine, viomycin, polymyxin B, netilmicin, neomycin, clindamycin, piperacillin and streptomycin),
• oral anticoagulants,
• amphotericin B (used in fungal infections),
• cyclosporin (an immunosuppressant),
• methoxyflurane (used for general anaesthesia during surgery),
• foscarnet (used in viral infections),
• cisplatin (used in the treatment of certain cancers),
• bisphosphonates (used in the treatment of osteoporosis),
• neostigmine, pyridostigmine (used in the treatment of muscle weakness),
• indomethacin (used in inflammatory conditions),
• intravenous contrast agents.

Indomethacin may also increase gentamicin levels in the blood in newborns.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Aminoglycoside antibiotics cross the placental barrier and may damage the fetus's hearing and balance organs. If you are pregnant, your doctor may prescribe Gentamycin Krka only in life-threatening situations when there is no other, safer antibiotic.
Breastfeeding
Gentamicin passes into breast milk, so breastfeeding is not recommended during treatment with Gentamycin Krka.

Driving and using machines

Gentamycin Krka may cause balance disorders, nausea and dizziness.
These symptoms may also occur after the end of treatment. During treatment, do not drive or operate machinery. If you experience disorders, consult your doctor.

Gentamycin Krka contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216).

The medicine may cause allergic reactions (including late allergic reactions) and bronchospasm.

Gentamycin Krka contains sodium metabisulfite (E 223).

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Gentamycin Krka contains sodium.

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means that it is considered "sodium-free".

3. How to use Gentamycin Krka

Dosage

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will determine the dose, frequency of administration and duration of treatment depending on the disease, the patient's tolerance to the medicine, response to treatment and any side effects.
Dosage in patients with normal kidney function
Children, adolescents and adults: 3 to 6 mg/kg body weight per day, administered in one dose (recommended) or divided into two doses administered every 12 hours.
Infants from 2 months of age:4.5 to 7.5 mg/kg body weight per day, administered in one dose (recommended) or divided into two doses administered every 12 hours.
Newborns:4 to 7 mg/kg body weight per day. Due to the longer half-life of the medicine in newborns, the daily dose is administered in a single dose.
Dosage in patients with renal impairment
The initial dose is the same as in patients with normal kidney function. During further treatment, your doctor may increase the intervals between doses or reduce the dose, depending on kidney function. Detailed recommendations are given at the end of the leaflet, in the section intended for healthcare professionals.

Method of administration

Gentamycin Krka is administered intramuscularly or intravenously. In both cases, the dose of the medicine is the same.
Detailed recommendations are given at the end of the leaflet, in the section intended for healthcare professionals.

Using a higher dose of Gentamycin Krka than recommended

Too high a dose or rapid administration of this medicine may lead to breathing difficulties, nausea, dizziness, vomiting, ringing or buzzing in the ears, a feeling of pressure in the ears and muscle cramps in the legs.
If you experience any of these symptoms or suspect that you have been given too high a dose of the medicine, tell your doctor.

Missing a dose of Gentamycin Krka

Your doctor will decide on the frequency of injections. If a planned injection is not given for any reason, inform your doctor.

Stopping treatment with Gentamycin Krka

If treatment is stopped too early, the symptoms of the disease may worsen.

4. Possible side effects

Like all medicines, Gentamycin Krka can cause side effects, although not everybody gets them.

If you experience any of the following side effects, tell your doctor immediately.

Symptoms that occur commonly(in 1 to 10 out of 100 patients)

• ringing, buzzing and a feeling of pressure in the ears (ear congestion), nausea, vomiting and dizziness

These may be the first symptoms of hearing and balance organ damage. Hearing and balance disorders, although rare, are usually irreversible and may worsen even after the end of treatment. The occurrence of these side effects is more likely in patients who have previously had hearing or balance disorders, patients with liver function disorders, those treated with other ototoxic medicines, those who do not drink enough fluids and those treated with high doses of Gentamycin Krka for a longer period. (See section 2 "Important information before using Gentamycin Krka")

• increased thirst and more or less frequent urination than usual

These may be symptoms of kidney function disorders, which occur more frequently in the elderly, women, patients who already have kidney function disorders and those who are not sufficiently hydrated and are treated with other nephrotoxic medicines.
Symptoms that occur rarely(in 1 to 10 out of 1,000 patients)

• hypersensitivity reactions (rash)

Symptoms that occur very rarely(in 1 to 10 out of 10,000 patients)

• breathing difficulties, low blood pressure, restlessness, weak rapid heartbeat, sweating (anaphylactic reaction)
• severe and prolonged diarrhoea, which may be a symptom of a specific type of colitis (pseudomembranous colitis)
• acute kidney failure
• high levels of phosphates and amino acids in the urine (a sign of acquired Fanconi syndrome associated with long-term administration of high doses of the medicine)

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

• transient and/or irreversible hearing loss, hearing loss (see section 2 "Important information before using Gentamycin Krka")
• fatigue
• confusion
• depression
• abnormal visions or sounds (hallucinations)
• nerve damage (including seizures, lack of energy, brain function disorders caused by a toxic substance or infection (encephalopathy))
• nerve damage in the arms and legs causing pain or numbness, burning and tingling (peripheral neuropathy),
• inflammation of the mucous membrane of the mouth.

Hypersensitivity reactions (including severe allergic reactions, such as anaphylaxis), which may include:

• itching, lumpy rash or urticaria
• swelling of the hands, feet, ankles, face, lips or throat, which may cause difficulty swallowing or breathing
• fainting, dizziness, feeling of dizziness (low blood pressure)
• infection with other gentamicin-resistant microorganisms
• diarrhoea with or without blood and/or stomach cramps

A severe allergic reaction of the skin and mucous membranes, accompanied by blisters and redness of the skin, which in very severe cases may affect internal organs and may be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome)).
Other side effects
Symptoms that occur commonly(in 1 to 10 out of 100 patients)

• dizziness, nystagmus
• nausea, vomiting, diarrhoea
• increased levels of creatinine and urea in the blood, protein in the urine

Symptoms that occur rarely(in 1 to 10 out of 1,000 patients)

• low levels of calcium, potassium and magnesium in the blood
• muscle weakness (neuromuscular blockade)

Symptoms that occur very rarely(in 1 to 10 out of 10,000 patients)

• decreased white blood cell and platelet count (leukopenia, thrombocytopenia), increased eosinophil count (a type of white blood cell), anaemia, decreased haemoglobin levels
• headache, fatigue, sensory disturbances (e.g. tingling)
• vision disorders
• increased bilirubin levels and increased liver enzyme activity (transaminases)
• increased body temperature, rapid heartbeat

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +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 authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gentamycin Krka

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date which is stated on the carton and ampoule after EXP.
The expiry date refers to the last day of that month.
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. Contents of the pack and other information

What Gentamycin Krka contains

• The active substance is gentamicin. 1 ml of solution for injection and infusion (1 ampoule of 1 ml) contains 40 mg of gentamicin in the form of sulfate. 2 ml of solution for injection and infusion (1 ampoule of 2 ml) contain 80 mg of gentamicin in the form of sulfate.
• The other ingredients are: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), disodium edetate, sodium metabisulfite (E 223), water for injections. See section 2 "Gentamycin Krka contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216).", "Gentamycin Krka contains sodium metabisulfite (E 223).", "Gentamycin Krka contains sodium."

What Gentamycin Krka looks like and contents of the pack

Gentamycin Krka is a clear, colourless or slightly yellowish solution, without visible mechanical impurities.
The pack contains 10 ampoules of 1 ml of solution for injection and infusion (40 mg/1 ml) or 10 ampoules of 2 ml of solution for injection and infusion (80 mg/2 ml).

Marketing authorisation holder and manufacturer

Krka d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
To obtain more detailed information on this medicine, please contact the local representative of the marketing authorisation holder:
Krka - Polska Sp. z o.o.
Równoległa 5
02-235 Warsaw
phone: +48 22 573 75 00
Date of last revision of the leaflet:05.10.2024

Information intended for healthcare professionals only: Dosage in patients with renal impairment

The initial dose is the same as in patients with normal kidney function. During further treatment, the intervals between doses should be increased or the dose reduced, depending on kidney function.
The table shows the dosage of gentamicin in patients with renal impairment.
Serum urea concentration
Creatinine clearance
Serum creatinine concentration
Dose and interval between doses
mg/100 ml
μmol/l
ml/min
ml/s
mg/100 ml
μmol/l
<40
<6-7
>70
>1.16
<1.4
<124
80 mg* every 8 hours
40-100
6-17
30-70
0.5-1.16
1.4-1.9
124-168
80 mg* every 12 hours
1.9-2.8
168-248
80 mg* every 18 hours
100-200
17-34
10-30
0.16-0.5
2.8-3.7
248-327
80 mg* every 24 hours
3.7-5.3
327-469
80 mg* every 36 hours
>200
>34
5-10
0.08-0.16
5.3-7.2
469-636
80 mg* every 48 hours
* Patients with a body weight of less than 60 kg are given 60 mg of gentamicin
Reducing the dose or increasing the interval between doses is equally appropriate, but it should be known that the doses determined in this way are only approximate and that despite the administration of the same doses of the medicine, the levels of the active substance in the blood may vary between patients. Therefore, in patients in a severe clinical condition, the level of gentamicin in the blood should be monitored and the doses adjusted accordingly. The level of gentamicin in the blood 30 to 60 minutes after intravenous or intramuscular administration should be at least 5 μg/ml.
After haemodialysis, gentamicin should be administered at a dose of 1 to 1.5 mg/kg body weight.
Patients undergoing peritoneal dialysis are given 1 mg of gentamicin per kg of body weight in 2 litres of dialysis fluid.
Method of administration
Intravenous and intramuscular administration.
Gentamicin is administered intramuscularly or intravenously. In both cases, the dose of the medicine is the same.
Due to the long post-antibiotic effect of gentamicin, the effect of each subsequent dose, administered during the post-antibiotic effect, is weaker, because the bacteria are less sensitive to the action of gentamicin during this time. Therefore, administering the medicine once a day is, from the point of view of the antibacterial effect of the medicine, twice as beneficial:

• due to the high initial concentration of gentamicin in the blood, its bactericidal effect is stronger,
• due to the longer interval between doses, the strength of the antibacterial effect of the next dose is greater.

It is not recommended to administer gentamicin once a day to patients with impaired immunity (neutropenia), severe renal impairment, cystic fibrosis, ascites, infectious endocarditis, patients with extensive burns (covering more than 20% of the body surface) and pregnant women.
In newborns, infants and children, after administration of gentamicin in the same doses as in adults, the levels of gentamicin in the blood are lower than in adults. Therefore, the therapeutic doses are slightly higher in them. For safety reasons, it is recommended to monitor the level of gentamicin in the blood in children daily. One hour after administration of gentamicin, its level in the blood should be at least 4 μg/ml.
If the daily dose of gentamicin is administered in divided doses, its level in the blood before the next dose should not be higher than 2 μg/ml. If the daily dose of gentamicin is administered in a single dose, its level in the blood before the next dose should not be higher than 1 μg/ml.
Intravenous administration
Gentamicin is administered directly into a vein or through a catheter placed in a vein. The administration time is 2 to 3 minutes. If gentamicin is administered in a single daily dose, it should be injected over 30 to 60 minutes.
Before administration in a short intravenous infusion, gentamicin should be diluted in 100 to 200 ml of 0.9% sodium chloride injection solution or 5% glucose injection solution. The concentration of gentamicin in the solution should not be higher than 1 mg/ml.
Incompatibilities
β-lactam antibiotics may inactivate gentamicin in vitro, so they should not be mixed in the same bottle with the infusion fluid.
Gentamicin should not be mixed with erythromycin, heparin or sodium bicarbonate.