GENTAMICINA 1 мг/мл Инфузионный раствор

Содержание инструкции

1. Gentamicina B. Braun 1 mg/ml solution for infusion, 3 mg/ml solution for infusion
   1. What is Gentamicina b. Braun 1 mg/ml or Gentamicina b. Braun 3 mg/ml and what
   2. What you need to know before you take Gentamicina B. BRAUN 1 mg/ml or
   3. How to take Gentamicina B. Braun 1 mg/ml, Gentamicina B. Braun 3 mg/ml
   4. Possible side effects
   5. How to store Gentamicina B. Braun 1 mg/ml Gentamicina, B. Braun 3 mg/ml
   6. Package Contents and Other Information

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

Gentamicina

Read this leaflet carefully before you use this medicine as 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 any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Contents of this leaflet
• 1. What Gentamicina B. Braun 1 mg/ml or Gentamicina B. Braun 3 mg/ml is and what it is used for.
• 2. What you need to know before you are given Gentamicina B. Braun 1 mg/ml or Gentamicina B. Braun 3 mg/ml.
• 3. How to use Gentamicina B. Braun 1 mg/ml or Gentamicina B. Braun 3 mg/ml.
• 4. Possible side effects
• 5. How to store Gentamicina B. Braun 1 mg/ml and Gentamicina B. Braun 3 mg/ml.
• 6. Contents of the pack and other information

1. What is Gentamicina b. Braun 1 mg/ml or Gentamicina b. Braun 3 mg/ml and what

is it used for
Gentamicina B. Braun 1 mg/ml or Gentamicina B. Braun 3 mg/ml belongs to a group of
medicines called antibiotics that are used to treat serious infections caused by bacteria
that can be eliminated by gentamicin, the active substance.
For the treatment of the diseases listed below, except for complicated infections of the kidneys,
urinary tract and bladder, Gentamicina B. Braun 1 mg/ml or Gentamicina B. Braun 3
mg/ml must be used only in association with other antibiotics.
You may receive Gentamicina B. Braun 1 mg/ml or Gentamicina B. Braun 3 mg/ml for the
treatment of the following diseases:

• complicated and recurrent infections of the kidneys, urinary tract and bladder;
• infections of the lungs and airways that occur during treatment in a hospital setting;
• infections of the abdomen, including inflammation of the peritoneum;
• infections of the skin and soft tissues, including severe burns;
• sepsis (an infection of the whole body), bacteria in the blood;
• inflammation of the internal lining of the heart (to treat infections);
• to treat infections after surgical procedures.

2. What you need to know before you take Gentamicina B. BRAUN 1 mg/ml or

Gentamicina B. BRAUN 3 mg/ml
This medicine should 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 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 have inner ear deafness. In this case you will only take gentamicin if your doctor considers it essential for the treatment of the disease you are suffering from. The doctor will ensure that your dose of gentamicin is appropriately adjusted.

The doctor will pay particular attention if you suffer from any disease that affects the
function of nerves and muscles, such as PARKINSON's disease, or if you receive a muscle
relaxant during a surgical operation, because gentamicin can cause a blockage of
nervous and muscular function.
You must immediately inform your doctor in case of severe diarrhea.
Your infection may not respond to gentamicin if your body has not reacted to
other aminoglycosides and you may have an allergic reaction to gentamicin, if you are already allergic to
another aminoglycoside.
There are only limited studies 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, the doctor will carefully evaluate the following:

• monitoring of hearing, balance and kidney function before, during and after treatment;
• dose strictly dependent on your kidney function;
• if you have impaired kidney function, the total dose will take into consideration the supplementary administration of antibiotics directly at the site of infection;
• monitoring of gentamicin concentrations in the serum during therapy, if the particularities of the case so require;
• if you have already suffered damage to the auditory nerve (impaired hearing or balance) or if long-term treatment is expected, supplementary monitoring of balance and hearing is necessary;
• if possible, you will receive therapy with gentamicin for no more than 10-14 days (usually 7 to 10 days);
• you must spend a sufficient amount of time, 7-14 days, between single treatments with gentamicin or with other closely related antibiotics;
• exclusion of the administration of other substances with potential harmful effects on the auditory nerve or kidneys together with gentamicin. If this is unavoidable, particularly careful monitoring of kidney function will be necessary;
• the level of body fluid and urine production must be normal. Other medicines and Gentamicina B. Braun 1 mg/ml Gentamicina B. Braun 3 mg/mlTell your doctor if you are taking, have recently taken or might take any other medicines. Caution should be exercised with the following medicines: Ether, muscle relaxantsThe blockage of nervous and muscular function by aminoglycosides is potentiated by ether and muscle relaxants. You will therefore be monitored with particular attention while receiving these substances. Anesthesia with methoxyfluraneThe anesthesiologist must know if you have taken or are taking aminoglycosides before performing

anesthesia with methoxyflurane (an anesthetic 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 subjected to very careful monitoring if you take gentamicin before, during
or after treatment with medicinal products containing the following substances:

• amphotericin B (against fungal infections);
• colistin (for intestinal decontamination);
• cyclosporine (for the suppression of unwanted immune reactions);
• cisplatin (an antineoplastic drug);
• vancomycin, streptomycin, viomycin, carbenicillin, other aminoglycosides, cephalosporins (antibiotics). You will also be subjected to very careful monitoring if you receive medicines to increase urine flow, containing e.g. ethacrinic acid and furosemide. Pregnancy and breastfeedingPregnancyIf you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with breast milk, ask your doctor for advice before taking this medicine. This medicine should not be used during pregnancy unless absolutely necessary. BreastfeedingTell your doctor if you are breastfeeding. The doctor will carefully assess whether you should stop breastfeeding or gentamicin therapy. Driving and using machinesCaution is advised when driving vehicles and using machines, considering possible side effects such as dizziness and vertigo. Gentamicina B. Braun 1 mg/ml and Gentamicina B. Braun 3 mg/ml contains sodiumThis medicinal product contains 283 mg of sodium per vial of solution for infusion. This must be taken into consideration by patients who are following a sodium-controlled diet. This medicinal product contains 283/425 mg of sodium per vial of 80/120 ml of solution for infusion. This must be taken into consideration by patients who are following a sodium-controlled 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 of body weight per day in 1 (preferred) to 2 single doses.
Normally, treatment with gentamicin does not last more than 7-10 days; treatment may
exceed 10 days only in cases of severe and complicated infections.
Your blood levels of gentamicin will be carefully monitored by analyzing blood samples
taken at the end of a dosing interval and immediately after the end of
the infusion, mainly to control your renal function. Your dose will be
carefully adjusted to avoid kidney damage.

Children(from 2 to 12 years)
The daily dose in neonates is 4-7 mg/kg of body weight per day. Neonates are given
the necessary daily dose in 1 single dose.
The daily dose in infants after the first month of life is 4.5-7.5 mg/kg of body weight
per day in 1 (preferred) to 2 single doses. The recommended daily dose in older children
with normal renal function is 3-6 mg/kg of body weight per day in 1
(preferred) to 2 single doses.

Dosage in patients with impaired renal function.
If you have impaired renal function, you will be monitored to appropriately adjust
the concentrations of gentamicin in the blood, by decreasing the dose or
prolonging the time between single doses. In this case, the doctor will know how to adjust the
dosage regimen.

Dosage in patients undergoing renal dialysis
In this case, your dose will be carefully adjusted based on your gentamicin level
in the blood.
Elderly patientsmay require lower maintenance doses than those of younger adults
to achieve sufficient gentamicin levels in the blood.
In severely overweight patients, the initial dose should be based on ideal body weight
plus 40 percent of excess weight.
For patients with hepatic impairment, no dosage adjustment is necessary.

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), further damage to the kidneys and auditory nerve may occur.
Treatment in case of overdose
Treatment will initially be discontinued. There is no specific antidote. Gentamicin can be removed from the blood with renal dialysis. For the treatment of blockage
of nerve and muscle function, calcium chloride may be administered and, if
necessary, artificial respiration may be performed.
If you have any doubts about the use of this medicine, ask your doctor or nurse.

Route of administration
Gentamicina B. Braun 1 mg/ml solution for infusion Gentamicina B. Braun 3 mg/ml
solution for infusion is administered via intravenous infusion directly into a vein.
The infusion solution in the polyethylene bottle is administered for a
period of 30-60 minutes.
Gentamicina B. Braun 1 mg/ml solution for infusion Gentamicina B. Braun 3 mg/ml
solution for infusion should not be administered by injection into the muscle or
vein (intramuscular or intravenous injection)

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Under certain conditions, gentamicin has toxic effects on the auditory nerve and kidneys.
Kidney impairment is commonly observed in patients treated with gentamicin and
usually resolves after discontinuation of the drug. In most cases, the
renal toxicity is associated with an excessively high dose or long-term
treatment, pre-existing kidney abnormalities, or other substances that also have a toxic effect
on the kidneys.
Further risk factors for renal toxicity are advanced age, low blood pressure,
decreased blood volume or shock, or known liver disease. Risk factors for toxic effects on the auditory nerve are liver and auditory impairment, the presence of bacteria in the
blood and fever.
The following side effects, which can occur very rarely, i.e. in less than
1 in 10,000 treated patients, may be serious and require immediate treatment:

• serious (allergic) hypersensitivity reactions;
• acute renal failure. Skin rashes, itching and difficulty breathing may be signs of acute hypersensitivity. A decrease in the amount of urine or complete cessation of urine (oliguria, anuria), excessive nighttime urination and generalized swelling (fluid retention) are signs of acute renal failure.

If any side effects occur, tell your doctor. This includes any possible side effects not listed in this leaflet.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the
safety of this medicine.

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

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial and the 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 Gentamicina B. Braun 3 mg/ml Contains
The active ingredient is gentamicin.
1 ml of Gentamicina B. Braun 1 mg/ml solution for infusion contains 1 mg of gentamicin,
as gentamicin sulfate.
1 vial of 80 ml contains 80 mg of gentamicin.
1 ml of Gentamicina B. Braun 3 mg/ml solution for infusion contains 3 mg of gentamicin,
as gentamicin sulfate.
1 vial of 80 ml contains 240 mg of gentamicin.
1 vial of 120 ml 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 solutions for infusion;
they are administered drop by drop through a small probe or cannula inserted into
a vein.
These are clear and colorless solutions.
Gentamicina B. Braun 1 mg/ml solution for infusion is available in polyethylene
vials of 80 ml
in packs of 10 or 20 vials.
Gentamicina B. Braun 3 mg/ml solution for infusion is available in polyethylene
vials of 80 or 120 ml 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 the Member States of the EEA with 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
Rep. Ceca 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. Braun1 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 healthcare professionals or operators:
Gentamicina B. Braun 1mg/ml solution for infusion and Gentamicina B. Braun 3 mg/ml
solution for infusion is a ready-to-use formulation and must not be diluted before
administration.
Never mix aminoglycosides in an infusion solution with beta-lactam antibiotics
(e.g. penicillins, cephalosporins), erythromycin or lipiphysan to avoid physicochemical
inactivation. This also applies to a combination of gentamicin with diazepam,
furosemide, flecainide acetate or sodium heparin.
The following active ingredients or the solution for reconstitution/dilution must not be
administered simultaneously:
gentamicin is incompatible with amphotericin B, cefalothin sodium, nitrofurantoin
sodium, sulfadiazine sodium and tetracyclines.
The addition of gentamicin to solutions containing bicarbonate may lead to release of
carbon dioxide.
From a microbiological point of view, the product must be used immediately. If not used
immediately, the storage times and conditions before use are the
responsibility of the user and should not normally exceed 24 hours at 2-8°C.
The solution must be administered with sterile equipment using aseptic technique.
The equipment must be filled with solution to prevent air from entering the
system.
For single use only.
Unused solution must be discarded.
Before administration, the solution must be visually inspected for the presence of
particles and discoloration. Use the solution only if it is clear and
free of particles.