Gentamicin b.braun

Package leaflet: Information for the user

Gentamicin B. BRAUN, 1 mg/ml, solution for infusion
Gentamicin B. BRAUN, 3 mg/ml, solution for infusion
Gentamicin
Please read all of this leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor.
• If you experience any adverse reactions, including any not listed in this leaflet, you must inform your doctor or nurse. See section 4.

Table of contents

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

1. What Gentamicin B. Braun is and what it is used for

Gentamicin B. Braun belongs to a group of antibiotics called aminoglycosides. These are used in the treatment of serious bacterial infections caused by bacteria susceptible to the active substance gentamicin.

Gentamicin B. Braun is used in combination with other antibiotics for the treatment of the following infections, except complicated urinary tract infections.

Gentamicin B. Braun may be used in patients for the treatment of the following conditions:

• complicated and recurrent kidney, urinary tract, and bladder infections;
• lung and respiratory tract infections occurring during hospital treatment;
• intra-abdominal infections, including peritonitis;
• skin and soft tissue infections, including severe burns;
• sepsis (bloodstream infection), bacteraemia;
• endocarditis (infection of the inner lining of the heart chambers and valves);
• postoperative infections.

2. Important information before using Gentamicin B. Braun

When not to use this medicine

• If the patient is allergic to gentamicin, other similar substances, or to any of the other ingredients of this medicine (listed in section 6).
• If the patient suffers from myasthenia gravis.

Warnings and precautions
Before starting treatment with this medicine, inform the doctor if:

• the patient is pregnant or breastfeeding;

• the patient has impaired kidney function or inner ear deafness;

• if the patient or family history reveals a disease associated with mitochondrial mutation (a genetic disorder) or hearing loss caused by antibiotic treatment, it is recommended to inform the doctor or pharmacist before using an aminoglycoside; certain mitochondrial mutations may increase the risk of hearing loss after
  administration of this medicine. Before administering Gentamicin B. Braun, the doctor may recommend genetic testing.
  In such cases, the patient will receive gentamicin only if the doctor considers it necessary for treating the disease. The doctor will pay special attention to the appropriate selection of the gentamicin dose for the patient.
  The doctor will exercise particular caution if the patient has any condition affecting nerve and muscle function, such as Parkinson's disease, or if the patient is concurrently receiving muscle relaxants, because gentamicin may inhibit nerve and muscle function.
  If the patient develops severe diarrhoea, inform the doctor or pharmacist.
  The infection may not respond to gentamicin if it did not respond to other aminoglycosides; the patient may experience an allergic reaction to gentamicin if previously allergic to other aminoglycosides.
  Experience with once-daily administration of gentamicin in elderly patients is limited.
  To reduce the risk of damage to the hearing organ or kidneys, the doctor will recommend:

• monitoring hearing, vestibular function, and kidney function before, during, and after treatment;

• dosing strictly adjusted according to kidney function;

• in patients with impaired kidney function – taking into account the dose of antibiotic administered locally in the total dosage;

• monitoring serum gentamicin concentrations during treatment, if necessary in a given case;

• additional monitoring of balance and hearing in patients with pre-existing inner ear damage (hearing or balance disorders) or during prolonged treatment;

• administering gentamicin for no longer than 10–14 days, if possible (usually 7–10 days);

• re-administration of gentamicin or another antibiotic derivative no earlier than 7–14 days after completion of treatment;

• avoiding concomitant use of other substances that may damage the auditory nerve or kidneys; if unavoidable, careful monitoring of kidney function is required;

• ensuring adequate fluid intake to maintain normal urine production.

Gentamicin B. Braun and other medicines
Inform the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Exercise caution when using the following medicinal products.
Neuromuscular blocking agents and ether
Neuromuscular transmission blockade caused by aminoglycosides is enhanced by ether and muscle relaxants. Therefore, patients receiving these substances will be monitored with special care.
Anaesthesia with methoxyflurane
Before starting anaesthesia with methoxyflurane (an anaesthetic gas), inform the anaesthesiologist that the patient is receiving aminoglycosides, so that use of this agent can be avoided if possible, due to increased risk of kidney damage.
Other medicines that may damage hearing or kidneys
The patient will be monitored particularly carefully if receiving gentamicin before, during, or after treatment with medicinal products containing the following substances:

• amphotericin B (for fungal infections),
• colistin (for bowel disinfection),
• cyclosporine (to suppress immune system reactions),
• cisplatin (an anticancer drug),
• vancomycin, streptomycin, viomycin, carbenicillin, other aminoglycosides, cephalosporins (antibiotics). Patients receiving diuretics such as ethacrynic acid or furosemide will also be closely monitored.

Pregnancy and breastfeeding
Pregnancy
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult the doctor before using this medicine. This medicine should not be used during pregnancy unless absolutely necessary.
Breastfeeding
If the patient is breastfeeding, she should inform the doctor. The doctor will carefully consider whether to discontinue breastfeeding or administration of gentamicin.
Driving and operating machinery
Caution is advised when driving or operating machinery due to the possibility of adverse effects such as dizziness or balance disorders.
Gentamicin B. Braun contains sodium
[Gentamicin B. Braun 1 mg/ml]
The medicine contains 283 mg of sodium (main component of table salt) per vial.
This corresponds to 14.2% of the maximum recommended daily dietary sodium intake for adults.
[Gentamicin B. Braun 3 mg/ml]
The medicine contains 283/425 mg of sodium (main component of table salt) per 80/120 ml vial.
This corresponds to 14.2%/21.3% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Gentamicin B. Braun

Dosage in patients with normal kidney function
Adults and adolescents
The recommended daily dose for adolescents and adults with normal kidney function is 3 to 6 mg/kg body
weight, administered as a single dose (recommended) or divided into two doses.
Treatment usually lasts no longer than 7–10 days; only treatment of acute and complicated infections may last
longer than 10 days.
Blood levels of gentamicin will be monitored—blood samples will be taken just before the next dose and
immediately after completion of infusion, primarily to monitor kidney function. The dose will be carefully
adjusted to avoid kidney damage.
Children
The daily dose for newborns is 4–7 mg/kg body weight. Newborns receive the required dose as a single daily
dose.
The daily dose for infants after the first month of life is 4.5–7.5 mg/kg body weight as a single dose
(recommended) or divided into two doses.
The recommended daily dose for older children with normal kidney function is 3 to 6 mg/kg body weight,
administered as a single dose (recommended) or divided into two doses.
Dosage in patients with impaired kidney function
If a patient has impaired kidney function, monitoring will be performed to ensure appropriate therapeutic
blood levels, achieved either by reducing the dose or increasing the dosing intervals. The treating physician
knows how to select the appropriate dosing regimen.
Dosage in dialyzed patients
In such cases, the physician will carefully adjust the dose according to the blood concentration of gentamicin.
Elderly patients – due to impaired kidney function, maintenance doses may need to be lower than in younger
adults.
Obese patients – the initial dose is calculated based on ideal body weight plus 40% of excess weight.
Patients with impaired liver function – no dose adjustment is necessary.
Accidental overdose of Gentamicin B. Braun
If drug accumulation occurs (e.g., due to impaired kidney function), additional kidney or auditory nerve
damage may occur.
Management in case of overdose
First, discontinue administration of the drug. There is no specific antidote. Gentamicin can be removed from
the blood by hemodialysis. If neuromuscular blockade occurs, calcium chloride may be administered and, if
necessary, assisted ventilation should be provided.
Method of administration
Gentamicin B. Braun is administered by intravenous infusion. The infusion solution contained in the
polyethylene bottle should be given over 30–60 minutes.
The infusion solution of Gentamicin B. Braun is not intended for intramuscular administration or for slow
intravenous injection (intramuscular or intravenous injections).
If you have any further questions about the use of this medicine, please consult your doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Under certain conditions, gentamicin may have harmful effects on hearing and the kidneys. Impaired kidney function is frequently observed in patients treated with gentamicin and usually resolves after discontinuation of the medicine. In most cases, it is associated with administration of too high a dose or prolonged treatment, pre-existing kidney dysfunction, or concomitant use of other substances harmful to the kidneys. Additional risk factors for kidney toxicity include: advanced age, low blood pressure, reduced blood volume, shock, or liver disease. Risk factors for ototoxicity (toxicity to the auditory nerve) include: liver disease, hearing disorders, presence of bacteria in the blood, and fever.

The following adverse effects, which may very rarely occur (i.e. less frequently than in 1 in 10,000 patients), may be severe and may require immediate treatment:

• severe acute hypersensitivity reactions (allergy);
• acute kidney failure.

Symptoms of acute hypersensitivity may include: skin rash, itching, and breathing difficulties.
Symptoms of acute kidney failure include: reduced or absent urine output (oliguria, anuria), excessive urination at night, and generalized swelling (fluid retention in the body).

Infections and parasitic infections
Unknown frequency (cannot be estimated from available data): Infections caused by bacteria resistant to gentamicin. Diarrhea with or without blood and (or) abdominal cramps.

Blood and lymphatic system disorders
Uncommon (may occur in 1 in 1,000 patients): Abnormal blood composition
Very rare (may occur less frequently than in 1 in 10,000 patients): Low numbers of various types of blood cells, increased number of eosinophils (a specific type of white blood cell)

Immune system disorders
Unknown frequency (cannot be estimated from available data): Allergic reactions (including severe reactions such as anaphylaxis), which may include:
 itchy, nodular rash or urticaria (hives)
 swelling of hands, feet, ankles, face, lips, or throat, which may cause difficulty in swallowing or breathing
 fainting, dizziness, feeling lightheaded (low blood pressure)

Metabolism and nutrition disorders
Rare (may occur in 1 to 10 in 10,000 patients): Low blood potassium, calcium, and magnesium levels (associated with long-term use of high doses), loss of appetite, weight loss
Very rare (may occur less frequently than in 1 in 10,000 patients): Low blood phosphate levels (associated with long-term use of high doses)

Psychiatric disorders
Very rare (may occur less frequently than in 1 in 10,000 patients): Confusion, hallucinations, depression

Nervous system disorders
Rare (may occur in 1 to 10 in 10,000 patients): Peripheral nerve damage, sensory disturbances or loss of sensation
Very rare (may occur less frequently than in 1 in 10,000 patients): Organic brain disorders, seizures, neuromuscular blockade, dizziness, balance disorders, headache

Eye disorders
Very rare (may occur less frequently than in 1 in 10,000 patients): Visual disturbances

Ear and labyrinth disorders
Very rare (may occur less frequently than in 1 in 10,000 patients): Damage to the auditory nerve, hearing loss, Meniere’s disease, ringing or buzzing in the ears (tinnitus), peripheral vertigo
Unknown frequency (cannot be estimated from available data): Irreversible hearing loss, deafness

Cardiac disorders
Very rare (may occur less frequently than in 1 in 10,000 patients): Low blood pressure, high blood pressure

Gastrointestinal disorders
Rare (may occur in 1 to 10 in 10,000 patients): Vomiting, nausea, excessive salivation, inflammation of the mouth

Hepatobiliary disorders
Rare (may occur in 1 to 10 in 10,000 patients): Transient increases in liver enzyme activity and blood bilirubin levels

Skin and subcutaneous tissue disorders
Uncommon (may occur in 1 in 10 to 1,000 patients): Allergic skin rash, itching
Rare (may occur in 1 to 10 in 10,000 patients): Skin redness
Very rare (may occur less frequently than in 1 in 10,000 patients): Hair loss, severe allergic skin and mucosal reactions with blistering and skin redness (erythema multiforme)
Unknown frequency (cannot be estimated from available data): Severe allergic skin and mucosal reactions with blistering and redness, potentially affecting other organs and life-threatening in severe cases (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Musculoskeletal and connective tissue disorders
Rare (may occur in 1 to 10 in 10,000 patients): Muscle pain
Very rare (may occur less frequently than in 1 in 10,000 patients): Muscle twitching (impairing ability to maintain standing posture or motor coordination)

Renal and urinary disorders
Common (may occur in 1 to 10 in 100 patients): Impaired kidney function (usually resolves after treatment ends)
Rare (may occur in 1 to 10 in 10,000 patients): Increased blood urea nitrogen (transient)
Very rare (may occur less frequently than in 1 in 10,000 patients): Acute kidney failure, high levels of phosphates and amino acids in urine (signs of acquired Fanconi syndrome associated with long-term administration of high doses)

General disorders and administration site conditions
Rare (may occur in 1 to 10 in 10,000 patients): Increased body temperature
Very rare (may occur less frequently than in 1 in 10,000 patients): Pain at injection site

If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Gentamicin B. Braun

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton after:
"Expiry date". The expiry date refers to the last day of the specified month.
No special storage conditions required for this medicine.
The solution should be used immediately after first opening.
The medicinal product is intended for single use only. Use only if the solution is
clear, colourless, and free from solid particles.
Dispose of any unused medicine.

6. Contents of the pack and other information

What Gentamicin B. Braun contains

• The active substance is gentamicin.

Infusion solution 1 mg/ml
1 ml of infusion solution Gentamicin B. Braun contains 1 mg of gentamicin as gentamicin sulfate.
One 80 ml vial contains 80 mg of gentamicin.

• Other ingredients are: sodium chloride, water for injections.

Infusion solution 3 mg/ml
1 ml of infusion solution Gentamicin B. Braun contains 3 mg of gentamicin as gentamicin sulfate.
One 80 ml vial contains 240 mg of gentamicin.
One 120 ml vial contains 360 mg of gentamicin.

• Other ingredients are: disodium edetate, sodium chloride, water for injections.

What Gentamicin B. Braun infusion solution looks like and contents of the pack
Gentamicin B. Braun is an infusion solution, which means it is administered via an intravenous drip through a thin tube or cannula placed into a vein.
The solution is clear and colourless.
Gentamicin B. Braun 1 mg/ml infusion solution is supplied in polyethylene bottles (Ecoflac plus) with a capacity of 80 ml.
The medicine is supplied in packs containing 10 or 20 bottles.
Gentamicin B. Braun 3 mg/ml infusion solution is supplied in polyethylene bottles (Ecoflac plus) with a capacity of 80 ml and 120 ml.
Both pack sizes are available in packs containing 10 or 20 bottles.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
B. Braun Melsungen AG
Carl-Braun-Straße 1
Correspondence address:
34212 Melsungen, Germany
34209 Melsungen, Germany
Telephone: +49/5661/71-0
Fax: +49/5661/71-4567

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

For further information, please contact the representative of the Marketing Authorisation Holder:
Aesculap Chifa Sp. z o.o.
ul. Tysiąclecia 14
64-300 Nowy Tomyśl
Tel. (61) 44 20 100

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Austria: Gentamicin B. Braun 1 mg/ml Infusionslösung
Gentamicin B. Braun 3 mg/ml Infusionslösung

Belgium: Gentamycine B. Braun 1 mg/ml Solution pour perfusion/Infusionslösung/Oplossing voor infusie YES Pharmaceutical Development Services
Gentamycine B. Braun 3 mg/ml Solution pour perfusion/Infusionslösung/Oplossing voor infusie

Czech Republic: Gentamicin B. Braun

Denmark: Gentamicin B. Braun

Iceland: Gentamicin B. Braun 1 mg/ml innrennslislyf, lausn
Gentamicin B. Braun 3 mg/ml innrennslislyf, lausn

Italy: Gentamicina B. Braun 1 mg/ml soluzione per infusione
Gentamicina B. Braun 3 mg/ml soluzione per infusione

Luxembourg: Gentamicin B. Braun 1 mg/ml Infusionslösung
Gentamicin B. Braun 3 mg/ml Infusionslösung

Norway: Gentamicin B. Braun 1 mg/ml infusjonsvæske, oppløsning
Gentamicin B. Braun 3 mg/ml infusjonsvæske, oppløsning

Poland: Gentamicin B. Braun
Gentamicin B. Braun

Portugal: Gentamicina B. Braun 1 mg/ml Solução para perfusão
Gentamicina B. Braun 3 mg/ml Solução para perfusão

Slovenia: Gentamicin B. Braun 1 mg/ml raztopina za infundiranje
Gentamicin B. Braun 3 mg/ml raztopina za infundiranje

Slovakia: Gentamicin B. Braun 1 mg/ml infúzny roztok
Gentamicin B. Braun 3 mg/ml infúzny roztok

United Kingdom (Northern Ireland): Gentamicin 1 mg/ml solution for infusion
Gentamicin 3 mg/ml solution for infusion

Other sources of information
Detailed information about this medicine is available on the website of {Office for Registration of Medicinal Products, Medical Devices and Biocidal Products | (urpl.gov.pl)}

Information intended exclusively for healthcare professionals

Gentamicin B. Braun infusion solution is ready for use and must not be diluted prior to administration.
Under no circumstances should aminoglycosides be mixed in the same infusion solution with beta-lactam antibiotics (e.g. penicillins, cephalosporins), erythromycin, or fat emulsion (a special oil-in-water emulsion for parenteral nutrition), as physicochemical inactivation may occur. This also applies to combinations of gentamicin with diazepam, furosemide, flecainide acetate, or sodium heparin.
Active substances or solvents/diluents that must not be administered simultaneously:
gentamicin is incompatible with amphotericin B, cephalothin sodium, sodium nitrofurantoin, and tetracyclines.
Addition of gentamicin to solutions containing bicarbonate may lead to release of carbon dioxide.
From a microbiological standpoint, the product should be used immediately. If the medicinal product is not used immediately, the user assumes full responsibility for storage duration and conditions prior to use; however, storage should generally not exceed 24 hours at a temperature of 2 to 8°C.
The solution should be administered using a sterile infusion set, applying aseptic technique.
The infusion set should be primed with the solution to prevent air from entering the system.
For single use only.
Any unused solution should be discarded.
Before administration, inspect the solution for particles or discoloration. The solution may only be used if it is clear and free from particles.