Gentamicin Bialmed

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language.

Gentamicin Bialmed (Gentamicin EIPICO), 40 mg/ml, solution for injection/infusion

Gentamicin
Gentamicin Bialmed and Gentamicin EIPICO are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should 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 side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Gentamicin Bialmed and what is it used for

Gentamicin Bialmed is an antibiotic from the aminoglycoside group. It kills bacteria that cause severe infections of the body.

When is Gentamicin Bialmed used

Gentamicin Bialmed is used to treat severe infections caused by aerobic Gram-negative 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 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 Gentamicin Bialmed

When not to use Gentamicin Bialmed

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 tell their doctor before starting to take Gentamicin Bialmed.
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 pseudo-membranous colitis - a life-threatening complication that can occur with the use of antibiotics. Appropriate treatment may be necessary. If gentamicin treatment causes diarrhoea, the patient should not take any medicines that slow down bowel movements (peristalsis).
During treatment with Gentamicin Bialmed, symptoms of hearing disorders may occur, especially in children, the elderly, patients with kidney function disorders, patients who have previously experienced such disorders, patients treated with other ototoxic medicines, patients who are not sufficiently hydrated or treated with higher doses of gentamicin for a longer period.
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 receiving high doses of gentamicin, the elderly, women, patients with kidney function disorders, patients who are not sufficiently hydrated, patients with nephrotic syndrome, patients with diabetic nephropathy and patients treated with other nephrotoxic medicines.

Gentamicin Bialmed and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
When Gentamicin Bialmed and other medicines are used at the same time, the risk of side effects increases. The patient should inform their doctor if they 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 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 using this medicine.
Pregnancy
Aminoglycoside antibiotics cross the placental barrier and may damage the foetus's hearing and balance organs. If the woman is pregnant, the doctor may recommend Gentamicin Bialmed only in life-threatening situations, when there is no other, safer antibiotic available.
Breastfeeding
Gentamicin passes into breast milk, so breastfeeding is not recommended during treatment with Gentamicin Bialmed.

Driving and using machines

Gentamicin Bialmed may cause balance disorders, nausea and dizziness. These symptoms may also occur after treatment has finished. During treatment, the patient should not drive vehicles or operate machines. If symptoms occur, the patient should consult their doctor.

Gentamicin Bialmed contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216).

The medicine may cause allergic reactions (including late-type reactions) and, rarely, bronchospasm.

Gentamicin Bialmed contains sodium metabisulphite (E 223).

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Gentamicin Bialmed contains sodium.

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

3. How to use Gentamicin Bialmed

Dosage

This medicine should always be used exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
The 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 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, 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, 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

Gentamicin Bialmed 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 Gentamicin Bialmed than recommended

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 that they have been given too high a dose of the medicine, they should tell their doctor.

Missing a dose of Gentamicin Bialmed

The frequency of injections is decided by the doctor. If a planned injection is not given for any reason, the patient should inform their doctor.

Stopping treatment with Gentamicin Bialmed

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

4. Possible side effects

Like all medicines, Gentamicin Bialmed can cause side effects, although not everybody gets them.

If the patient experiences any of the following side effects, they should immediately inform their doctor.

Side effects that occur not very often(in 1 to 10 out of 100 patients)

• ringing, buzzing and 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 patients who have previously experienced hearing or balance disorders, patients with liver function disorders, patients treated with other ototoxic medicines, patients who do not drink enough fluids and patients receiving high doses of Gentamicin Bialmed for a longer period. (See section 2 "Important information before using Gentamicin Bialmed")

• more frequent than usual feeling of thirst and more frequent or less frequent than usual urination

These may be symptoms of kidney function disorders, which occur more frequently in the elderly, women, patients with pre-existing kidney function disorders and patients who are not sufficiently hydrated and are treated with other nephrotoxic medicines.
Side effects that occur rarely(in 1 to 10 out of 1000 patients)

• hypersensitivity reactions (rash)

Side effects 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, deafness (see section 2 "Important information before using Gentamicin Bialmed")
• fatigue
• feeling of 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 hands and feet causing pain or numbness, burning and tingling (peripheral neuropathy),
• inflammation of the mouth mucosa.

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

• itchy, 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

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
Side effects that occur not very often(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

Side effects that occur rarely(in 1 to 10 out of 1000 patients)

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

Side effects 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Gentamicin Bialmed

The medicine should be stored out of the sight and reach of children.
Store in a temperature below 30°C in the original packaging. Do not store in the refrigerator or freeze.
Do not use this medicine after the expiry date stated on the carton and ampoule after: EXP.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Gentamicin Bialmed contains

• The active substance of the medicine is gentamicin. 2 ml of the solution for injection/infusion (1 ampoule of 2 ml) contains 80 mg of gentamicin in the form of gentamicin 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 "Gentamicin Bialmed contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216).", "Gentamicin Bialmed contains sodium metabisulphite (E 223).", "Gentamicin Bialmed contains sodium."

What Gentamicin Bialmed looks like and contents of the pack

Gentamicin Bialmed is a clear, colourless or slightly yellowish solution, without visible mechanical impurities.
The pack contains 10 ampoules of 2 ml of the solution for injection/infusion (80 mg/2 ml).
For more detailed information, the patient should contact the marketing authorisation holder or parallel importer.

Marketing authorisation holder in Romania, the country of export:

E.I.P.I.CO MED S.R.L.
Unirii Boulevard no. 6, Bl. 8C sc.1, ap 9, Sector 4
Bucharest, Romania

Manufacturer:

FELSIN Farm. S.R.L.
Drumul Piscul Cerbului Street, no. 20-28, etaj P, camerele 1-9 și etaj, sector 1
Bucharest, Romania

Parallel importer:

Bialmed Sp. z o.o.
Kazimierzowska Street 46/48/35
02-546 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
Działkowa Street 56
02-234 Warsaw
LABOR Pharmaceutical-Chemical Enterprise Sp. z o.o.
Długosza Street 49
51-162 Wrocław

Marketing authorisation number in Romania, the country of export: 8064/2015/01

Parallel import authorisation number: 294/24

Date of leaflet approval: 22.07.2024

[parallel importer's logo]

Information intended only for healthcare professionals: 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.
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 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 noted 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 levels 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 in a dose of 1 to 1.5 mg/kg body weight.
Patients undergoing peritoneal dialysis should be 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, because the bacteria are less sensitive to the action of 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 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 these patients. For safety reasons, it is recommended to monitor the levels of gentamicin in the blood in children on a daily basis. 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 either.