Gentamicin B. Braun

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gentamicin B. Braun 1 mg/ml solution for infusion, 3 mg/ml solution for infusion

Gentamicin
Read this leaflet carefully before using 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.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet

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

1. What Gentamicin B. Braun 1 mg/ml or Gentamicin B. Braun 3 mg/ml is and what it is used for

What it is
Gentamicin B. Braun 1 mg/ml or Gentamicin B. Braun 3 mg/ml belongs to a group of
medicines called antibiotics, which are used to treat serious bacterial infections caused by organisms susceptible to gentamicin, the active substance.

For the treatment of the conditions listed below, except for complicated infections of the kidneys, urinary tract, and bladder, Gentamicin B. Braun 1 mg/ml or Gentamicin B. Braun 3 mg/ml should be used only in combination with other antibiotics.

You may receive Gentamicin B. Braun 1 mg/ml or Gentamicin B. Braun 3 mg/ml for the treatment of the following conditions:

• complicated and recurrent infections of the kidneys, urinary tract, and bladder;
• lung and respiratory tract infections occurring during hospital treatment;
• abdominal infections, including peritonitis;
• skin and soft tissue infections, including severe burns;
• sepsis (a systemic infection), bacteria in the blood;
• inflammation of the inner lining of the heart (to treat infections);
• infections following surgical procedures.

2. What you should know before taking Gentamicin B. BRAUN 1 mg/ml or

Gentamicin B. BRAUN 3 mg/ml
This medicinal product must not be used

• if you are allergic to gentamicin, to other similar substances, or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from severe myasthenia gravis.

Warnings and precautions
Talk to your doctor before taking this medicine if:

• you are pregnant or breastfeeding;
• you have impaired kidney function or inner ear hearing loss. In such cases, you will only be given gentamicin if your doctor considers it essential for treating your illness. Your doctor will carefully adjust your gentamicin dosage as appropriate.

Your doctor will pay particular attention if you suffer from any disease affecting nerve and muscle function, such as PARKINSON's disease, or if you are receiving a muscle relaxant during surgery, because gentamicin may cause blockade of nerve and muscle function.
You must inform your doctor immediately if you develop severe diarrhoea.
Your infection may not respond to gentamicin if your body has previously not responded to other aminoglycosides, and you may have an allergic reaction to gentamicin if you are already allergic to another aminoglycoside.
There are only limited data on the administration of a single daily dose of gentamicin in elderly patients.
To reduce the risk of damage to the auditory nerve or kidneys, your doctor will carefully consider the following:

• monitoring of hearing, balance, and kidney function before, during, and after treatment;
• dosage strictly adjusted according to your kidney function;
• if you have impaired kidney function, additional administration of antibiotics directly into the site of infection will be considered when determining the total dose;
• monitoring of gentamicin serum concentrations during therapy, if the individual case requires it;
• if you have previously experienced damage to the auditory nerve (hearing or balance impairment), or if long-term treatment is expected, additional monitoring of balance and hearing is necessary;
• if possible, your gentamicin therapy should not exceed 10–14 days (normally 7–10 days);
• a sufficient interval of 7–14 days should elapse between individual courses of gentamicin or other closely related antibiotics;
• avoid concomitant administration of other substances with potential harmful effects on the auditory nerve or kidneys together with gentamicin. If this is unavoidable, particularly close monitoring of kidney function will be required;
• your body fluid levels and urine output should be within normal range.

Other medicines and Gentamicin B. Braun 1 mg/ml Gentamicin B. Braun 3 mg/ml
Inform your doctor if you are taking, have recently taken, or might take any other medicines. Special caution is required with the following medicines:

Ether, muscle relaxants
The nerve and muscle blockade caused by aminoglycosides is enhanced by ether and muscle relaxants. You will therefore be monitored particularly closely while receiving these substances.

Anaesthesia with methoxyflurane
The anaesthetist must know if you have taken or are currently taking aminoglycosides before administering anaesthesia with methoxyflurane (an anaesthetic gas), and, if possible, should avoid using this substance due to the increased risk of kidney damage.

Other medicinal products with potential harmful effects on the auditory nerve and kidneys
You will be closely monitored if you take gentamicin before, during, or after treatment with medicinal products containing the following substances:

• amphotericin B (for fungal infections);
• colistin (for intestinal decontamination);
• ciclosporin (to suppress unwanted immune reactions);
• cisplatin (an antineoplastic agent);
• vancomycin, streptomycin, viomycin, carbenicillin, other aminoglycosides, cephalosporins (antibiotics).

You will also be closely monitored if you receive diuretic medicines (to increase urine flow) containing, for example, ethacrynic acid or furosemide.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. This medicine should not be used during pregnancy unless absolutely necessary.

Breastfeeding
Inform your doctor if you are breastfeeding. Your doctor will carefully assess whether you should discontinue breastfeeding or the gentamicin therapy.

Driving and using machines
Caution is advised when driving vehicles or operating machinery, due to possible adverse effects such as dizziness and vertigo.

Gentamicin B. Braun 1 mg/ml and Gentamicin B. Braun 3 mg/ml contains sodium
This medicinal product contains 283 mg of sodium per infusion vial. This should be taken into account by patients on a controlled sodium diet. This medicinal product contains 283/425 mg of sodium per 80/120 ml infusion vial. This should be taken into account by patients on a controlled sodium diet.

3. How to take Gentamicina B. Braun 1 mg/ml, Gentamicina B. Braun 3 mg/ml

Dosage in patients with normal renal function
Adults/Adolescents
The recommended daily dose in adolescents and adults with normal renal function is
3–6 mg/kg body weight per day, given as 1 (preferably) up to 2 single doses.
Normally, a gentamicin treatment does not last longer than 7–10 days; treatment may
exceed 10 days only in cases of severe and complicated infections.
Your blood levels of gentamicin will be closely monitored by analyzing blood samples
taken at the end of a dosing interval and immediately after completion of the infusion,
primarily to monitor your renal function. Your dose will be carefully adjusted to avoid
renal damage.
Children (from 2 to 12 years of age)
The daily dose in neonates is 4–7 mg/kg body weight per day. In neonates, the required
daily dose is administered as a single dose.
The daily dose in infants after the first month of life is 4.5–7.5 mg/kg body weight per day,
given as 1 (preferably) up to 2 single doses. The recommended daily dose in older children
with normal renal function is 3–6 mg/kg body weight per day, given as 1 (preferably) up
to 2 single doses.
Dosage in patients with impaired renal function
If you have impaired renal function, you will be monitored so that gentamicin blood
concentrations can be appropriately adjusted by reducing the dose or prolonging the
interval between doses. In this case, your doctor will know how to adjust the dosing regimen.
Dosage in patients undergoing renal dialysis
In this case, your dose will be carefully adjusted based on your blood gentamicin levels.
Elderly patients may require lower maintenance doses than younger adults to achieve
adequate blood levels of gentamicin.
In heavily overweight patients, the initial dose should be based on ideal body weight plus
40 percent of excess weight.
No dosage adjustment is necessary in patients with impaired hepatic function.
If you take more Gentamicina B. Braun 1 mg/ml or Gentamicina B. Braun 3 mg/ml than
you should
In case of accumulation (e.g., as a result of impaired renal function), additional damage
to the kidneys and the auditory nerve may occur.
Treatment in case of overdose
Treatment will be initially discontinued. There is no specific antidote. Gentamicin can be
removed from the blood by renal dialysis. For treatment of neuromuscular blockade,
calcium chloride may be administered, and if necessary, artificial respiration may be performed.
If you have any doubts about the use of this medicine, consult your doctor or nurse.
Method of administration
Gentamicina B. Braun 1 mg/ml solution for infusion and Gentamicina B. Braun 3 mg/ml
solution for infusion are administered via intravenous infusion (intravenous infusion). The infusion solution in the polyethylene vial should be administered over a period of 30–60 minutes.
Gentamicina B. Braun 1 mg/ml solution for infusion and Gentamicina B. Braun 3 mg/ml
solution for infusion must not be administered by intramuscular or intravenous injection.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Under certain conditions, gentamicin may have toxic effects on the auditory nerve and the kidneys.
Kidney impairment is commonly observed in patients treated with gentamicin and usually resolves after discontinuation of the drug. In most cases, renal toxicity is associated with excessively high doses or prolonged treatment, pre-existing kidney abnormalities, or concomitant use of other substances that also have kidney toxic effects.
Additional risk factors for renal toxicity include advanced age, low blood pressure, reduced blood volume, or shock, or known liver disease. Risk factors for toxic effects on the auditory nerve include liver and hearing impairment, presence of bacteria in the blood (bacteraemia), and fever.
The following side effects, which may occur very rarely, i.e. in less than 1 in 10,000 treated patients, can be severe and require immediate treatment:

• severe acute (allergic) hypersensitivity reactions;
• acute renal failure. Skin rashes, itching, and breathing difficulties may be signs of acute hypersensitivity. Decreased urine output or complete cessation of urine (oliguria, anuria), excessive urination at night, and generalized swelling (fluid retention) are signs of acute renal failure.

If you experience any adverse reaction, consult your doctor. This includes any
possible adverse reaction not listed in this leaflet.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your
doctor, pharmacist, or nurse. You may also report adverse reactions directly through the
national reporting system available at the website
www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, you can help provide more information on the safety of this
medicinal product.

5. How to store Gentamicina B. Braun 1 mg/ml, Gentamicina B. Braun 3 mg/ml

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial and outer carton after "Exp.". The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
The solution must be used immediately after first opening.
This medicinal product is for single use only. Use the solution only if it is clear, colourless and free from particles.
Any unused solution must be discarded.

6. Package contents and other information

What Gentamicina B. Braun 1 mg/ml and Gentamicina B. Braun 3 mg/ml contain
The active substance is gentamicin.
1 ml of Gentamicina B. Braun 1 mg/ml infusion solution contains 1 mg of gentamicin
as gentamicin sulfate.
One 80 ml vial contains 80 mg of gentamicin.
1 ml of Gentamicina B. Braun 3 mg/ml infusion solution 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.
The excipients are:
disodium edetate (3 mg/ml solution), sodium chloride, water for injections.

Description of the appearance of Gentamicina B. Braun 1 mg/ml and Gentamicina B. Braun 3 mg/ml and package contents
Gentamicina B. Braun 1 mg/ml and Gentamicina B. Braun 3 mg/ml are infusion solutions;
they are administered drop by drop through a small catheter or cannula inserted into a vein.
They are clear, colourless solutions.
Gentamicina B. Braun 1 mg/ml infusion solution is available in 80 ml polyethylene vials,
in packs of 10 or 20 vials.
Gentamicina B. Braun 3 mg/ml infusion solution is available in 80 ml or 120 ml polyethylene vials,
in packs of 10 or 20 vials.
Not all pack sizes may be marketed.

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

Manufacturer
B. Braun Medical SA
Carretera de Terrasa, 121
08191 Rubi (Barcelona)
Spain

This medicinal product is authorised in EEA Member States 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
Gentamycine B. Braun 3 mg/ml Solution pour perfusion / Infusionslösung / Oplossing voor infusie
Czech Republic: Gentamicin B. Braun 1 mg/ml
Gentamicin B. Braun 3 mg/ml
Denmark: Gentamicin B. Braun
Germany: Gentamicin B. Braun 1 mg/ml Infusionslösung
Gentamicin B. Braun 3 mg/ml Infusionslösung
Greece: Gentamicin B. Braun 1 mg/ml
Gentamicin B. Braun 3 mg/ml
Finland: Gentamicin B. Braun 1 mg/ml
Gentamicin B. Braun 3 mg/ml
France: Gentamicine B. Braun 1 mg/ml solution pour perfusion
Gentamicine B. Braun 3 mg/ml solution pour perfusion
Ireland: Gentamicin 1 mg/ml solution for infusion
Gentamicin 3 mg/ml solution for infusion
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
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: Gentamicin 1 mg/ml solution for infusion
Gentamicin 3 mg/ml solution for infusion

The following information is intended exclusively for medical or healthcare professionals:
Gentamicina B. Braun 1 mg/ml infusion solution and Gentamicina B. Braun 3 mg/ml infusion solution are ready-to-use formulations and must not be diluted prior to administration.
Never mix aminoglycosides in an infusion solution with beta-lactam antibiotics (e.g. penicillins, cephalosporins), erythromycin or lipiphysan to avoid physico-chemical inactivation. This also applies to combinations of gentamicin with diazepam, furosemide, flecainide acetate or sodium heparin.
The following active substances or reconstitution/dilution solutions must not be administered simultaneously:
gentamicin is incompatible with amphotericin B, cephalothin sodium, sodium nitrofurantoin, sodium sulfadiazine and tetracyclines.
Adding gentamicin to solutions containing bicarbonate may result in the release of carbon dioxide.
From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8°C.
The solution must be administered using sterile equipment and aseptic technique. The administration set must be filled with solution to prevent air from entering the system.
For single use only.
Any unused solution must be discarded.
Before administration, the solution should be inspected visually for the presence of particles and discoloration. Use the solution only if it is clear and free from particles.