Gentamicin Krka

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

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

Gentamicin
Gentamycin Krka and Gentamicin Krka are different trade names for the same medicine.

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Gentamycin Krka is an antibiotic from 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 medicine is usually administered together with metronidazole or clindamycin),
• urinary tract infections,
• respiratory tract infections,
• secondary infections of burns and traumatic and postoperative wounds,
• severe infections in newborns.

2. Important information before taking Gentamycin Krka

When not to take Gentamycin Krka

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

Warnings and precautions

If the patient has any chronic disease, has metabolic disorders, hypersensitivity (allergy) to other medicines, or is taking other medicines, they should inform their doctor before starting to take Gentamycin Krka.
The patient should also inform their doctor if:

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

If the patient experiences severe or prolonged diarrhoea associated with gentamicin treatment, they should immediately consult a doctor, who will determine whether it is not a potentially life-threatening complication called pseudomembranous colitis, which sometimes occurs as a result of taking antibiotics. Appropriate treatment may be necessary. If gentamicin treatment causes diarrhoea, 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, those who have previously experienced such disorders, patients treated with other ototoxic medicines, those who are not sufficiently hydrated, or those treated with higher doses of gentamicin for a longer period, may occur.
The doctor will closely monitor the patient's condition during treatment to prevent hearing damage. They may examine the patient's hearing, balance, kidney function, and gentamicin levels in the blood.
Gentamicin may cause kidney function disorders. This is more common in patients taking high doses of gentamicin, the elderly, women, patients with kidney function disorders, those who are not sufficiently hydrated, patients with nephrotic syndrome, those with diabetic nephropathy, and patients treated with other nephrotoxic medicines.

Gentamycin Krka and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
When Gentamycin Krka and other medicines are taken at the same time, the risk of side effects increases. 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 immunosuppressive medicine),
• 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 of newborns.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Aminoglycoside antibiotics cross the placental barrier and may harm the foetus's hearing and balance organs. If a woman is pregnant, the doctor may prescribe Gentamycin Krka only in life-threatening situations when no other, safer antibiotic is available.
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 treatment has finished. During treatment, do not drive or operate machinery. If symptoms occur, consult a doctor.

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

The medicine may cause allergic reactions (possible late reactions) and, exceptionally, bronchospasm.

Gentamycin Krka contains sodium metabisulphite (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 the medicine is considered 'sodium-free'.

3. How to take Gentamycin Krka

Dosage

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
The doctor will determine the dose, frequency of administration, and duration of treatment based on the disease, the patient's tolerance to the medicine, response to treatment, and any side effects.
Dosage for patients with normal kidney function
Children, adolescents, and adults:3 to 6 mg/kg body weight per day, administered in a single 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 a single 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, they are given the daily dose in a single dose.
Dosage for patients with kidney impairment
The initial dose is the same as for patients with normal kidney function. During further treatment, the 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.

Overdose of Gentamycin Krka

Too high doses or rapid administration of this medicine may lead to breathing difficulties, nausea, dizziness, vomiting, ringing or buzzing in the ears, feeling of pressure in the ears, and muscle cramps in the legs.
If the patient experiences such symptoms or suspects they have been given too high a dose of the medicine, they should inform their doctor.

Missed dose of Gentamycin Krka

The frequency of injections is determined by the doctor. If a planned injection is not given for any reason, the doctor should be informed.

Stopping treatment with Gentamycin Krka

If treatment is stopped prematurely, 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.

Uncommon side effects (may affect up to 1 in 10 people)

• ringing, buzzing, or 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 treatment has finished. The occurrence of these side effects is more likely in people who have previously experienced hearing or balance disorders, those with liver function disorders, those treated with other ototoxic medicines, those who do not drink enough fluids, and those receiving high doses of Gentamycin Krka for a longer period. (See section 2 "Important information before taking 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 with pre-existing kidney function disorders, those who are not sufficiently hydrated, and those treated with other nephrotoxic medicines.
Rare side effects (may affect up to 1 in 1,000 people)

• hypersensitivity reactions (rash)

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

• 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, deafness (See section 2 "Important information before taking Gentamycin Krka")
• fatigue
• confusion
• depression
• abnormal visions or sounds (hallucinations)
• nerve damage (including seizures, lack of energy, brain function disorders caused by the action of a harmful substance or infection (encephalopathy))
• nerve damage in the hands and feet causing pain or numbness, burning, and tingling (peripheral neuropathy),
• inflammation of the mucous membrane of the mouth.

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

• itchy, lumpy rash or hives
• 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

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 be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome)).
Other side effects
Uncommon side effects (may affect up to 1 in 100 people)

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

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

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

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

• decreased white blood cell and platelet count (leukopenia, thrombocytopenia), increased eosinophil count (a type of white blood cell), anaemia, decreased haemoglobin levels
• headache, fatigue, sensation disorders (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, tell your doctor, pharmacist, or nurse. 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
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gentamycin Krka

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the 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 packaging and other information

What Gentamycin Krka contains

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

What Gentamycin Krka looks like and contents of the packaging

Gentamycin Krka is a clear, colourless or slightly yellowish solution, without visible mechanical impurities.
The packaging contains 10 ampoules of 1 ml of the solution for injection and infusion (40 mg/1 ml) or 10 ampoules of 2 ml of the solution for injection and infusion (80 mg/2 ml).
For more detailed information, please contact the marketing authorisation holder or parallel importer.

Marketing authorisation holder in Romania, the country of export:

Krka d.d. Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer:

Krka d.d. Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorisation number in Romania, the country of export:
13060/2020/01
13061/2020/01

Parallel import authorisation number: 370/24

Date of leaflet approval:22.10.2024
[Information about the trademark]

Information intended only for healthcare professionals: Dosage for patients with kidney impairment

The initial dose is the same as for 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 for patients with kidney impairment.
Urea levels in the blood
Creatinine clearance
Creatinine levels in the blood
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 weighing 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 gentamicin level in the blood should be monitored and the dose adjusted accordingly. The gentamicin level 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/kg 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, as the bacteria are less sensitive to gentamicin during this time. Therefore, administering the medicine once a day is twice as beneficial from the point of view of the medicine's antibacterial effect:

• due to the high initial gentamicin concentration 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 kidney impairment, cystic fibrosis, ascites, infectious endocarditis, those 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 gentamicin levels 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 gentamicin level in the blood daily in children. One hour after gentamicin administration, the level in the blood should be at least 4 μg/ml.
If the daily dose of gentamicin is administered in divided doses, the 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, the 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 gentamicin concentration 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 either.