TOBRAMYCIN 3 mg /Ml Solution

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Tobramycin B. Braun, 1 mg/ml, solution for infusion
3. Tobramycin B. Braun, 3 mg/ml, solution for infusion
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Tobramycin B. Braun and what is it used for
5. Important information before using Tobramycin B. Braun
   1. When not to use Tobramycin B. Braun
   2. Warnings and precautions
   3. Tobramycin B. Braun and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Tobramycin B. Braun contains sodium
6. How to use Tobramycin B. Braun
   1. Dosing in patients with normal kidney function
   2. Dosing in patients with kidney function disorders
   3. Patients with significant overweight
   4. Duration of treatment
   5. Using a higher dose of Tobramycin B. Braun than recommended
7. Possible side effects
   1. The following side effects, which may occur only rarely, may be severe and require immediate treatment:
   2. Reporting side effects
8. How to store Tobramycin B. Braun
9. Contents of the packaging and other information
   1. What Tobramycin B. Braun contains
   2. What Tobramycin B. Braun looks like and contents of the packaging
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet: 2021-11-11
   7. Information intended for healthcare professionals only:

Leaflet attached to the packaging: information for the user

Tobramycin B. Braun, 1 mg/ml, solution for infusion

Tobramycin B. Braun, 3 mg/ml, solution for infusion

Tobramycin

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or nurse. See section 4.

Table of contents of the leaflet

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

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

Tobramycin B. Braun belongs to a group of medicines called antibiotics, i.e. it is used to treat severe infections caused by bacteria that can be killed by the active substance - tobramycin.
The patient may receive tobramycin to treat the following diseases:

• hospital-acquired infections of the lungs and lower respiratory tract;
• lung and lower respiratory tract infections in patients with cystic fibrosis;
• complicated and recurrent infections of the kidneys, urinary tract, and bladder;
• intra-abdominal infections;
• skin and soft tissue infections, including severe burns. If necessary, therapy may also include other antibiotics.

2. Important information before using Tobramycin B. Braun

When not to use Tobramycin B. Braun

Warnings and precautions

Before starting treatment with Tobramycin B. Braun 1 mg/ml or 3 mg/ml, discuss it with your doctor or pharmacist.
Particular caution should be exercised if

• the patient has kidney disease,
• the patient has hearing disorders or any inner ear abnormalities,
• the patient has Parkinson's disease,
• if the patient or their family members have a disease related to mitochondrial mutation (a disease caused by variants of mitochondrial genomes, parts of cells involved in energy production) or hearing loss caused by antibiotic drugs; some mitochondrial mutations may increase the risk of hearing loss after using this medicine.

If the patient has any of the above diseases, they should inform their doctor.
Tobramycin may have a harmful effect on the kidneys and the auditory nerve, so the patient will be closely monitored for any symptoms that may indicate such damage during treatment.
Monitoring of kidney function, hearing, and balance is particularly important when the patient already has

• or may have - kidney function disorders or when kidney function deteriorates during treatment.

Avoid using tobramycin with rapidly acting drugs that increase urine production, or other drugs that may also damage the kidneys and the auditory nerve.
Monitoring will include

• kidney function, especially if the patient is elderly or has impaired kidney function,
• hearing,
• tobramycin concentration in the blood, as often as possible.

If symptoms of kidney function impairment or worsening kidney function occur, the daily doses will be reduced and (or) the interval between doses will be extended. If kidney function disorders become severe, therapy will be discontinued. Tobramycin treatment will also be discontinued if there is damage to the auditory nerve, manifested by tinnitus or hearing loss.
If the patient experiences severe diarrhea, they should immediately inform their doctor.
If muscle blockage occurs, it can be treated with calcium salts.
During treatment, fluid and electrolyte levels will be monitored.
If the patient has extensive burn wounds, the tobramycin concentration in the blood will be closely monitored.
If the patient is undergoing surgical procedures involving wound irrigation with solutions containing tobramycin or other aminoglycosides, this will be taken into account when determining the tobramycin dose.
Particular caution should be exercised if the patient is elderly.
Children
In premature and full-term newborns, tobramycin will be administered with particular caution.

Tobramycin B. Braun and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Pay attention to the medicines listed below.
Muscle relaxants, ether, citrated blood:
They may increase the risk of nerve or muscle blockage. Such a combination will be avoided whenever possible.
Methoxyflurane anesthesia
Inform your anesthesiologist before undergoing methoxyflurane anesthesia (an anesthetic gas) that you have taken or are taking aminoglycosides, and avoid using methoxyflurane whenever possible due to the increased risk of kidney damage.
Other medicines that may also damage the kidneys and the auditory nerve
The harmful effect of tobramycin on the kidneys and the auditory nerve may be enhanced by:

• other substances used to treat infections, such as amphotericin B, polymyxin B, colistin, cephalothin, aminoglycosides;
• cisplatin (an anticancer drug - in this case, kidney damage may occur even three to four weeks after administration of these drugs);
• cyclosporine, tacrolimus (a substance that suppresses unwanted immune reactions);
• rapidly acting drugs that increase urine production: furosemide or ethacrynic acid. Whenever possible, avoid administering these drugs simultaneously with tobramycin or after using tobramycin.

Other antibiotics
Combination therapy with appropriate antibiotics (e.g. beta-lactams) may significantly enhance the therapeutic effect. However, the effect of tobramycin is weakened by antibiotics similar to penicillin, if the patient has severe kidney function disorders.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Pregnancy
If you are pregnant, your doctor will prescribe this medicine only if it is absolutely necessary.
Breastfeeding
Although tobramycin is not usually absorbed in the intestines of breastfed children, your doctor will carefully consider whether to discontinue breastfeeding or treatment with tobramycin.

Driving and using machines

Caution is recommended when driving vehicles and operating machines due to possible side effects such as dizziness.

Tobramycin B. Braun contains sodium

Tobramycin B. Braun, 1 mg/ml
The medicine contains 283 mg of sodium (the main component of common salt) in each 80 ml vial. This corresponds to 14.2% of the maximum recommended daily sodium intake in the diet for adults.
Tobramycin B. Braun, 3 mg/ml
The medicine contains 283 mg of sodium (the main component of common salt) in each 80 ml vial. This corresponds to 14.2% of the maximum recommended daily sodium intake in the diet for adults.
The medicine contains 425 mg of sodium (the main component of common salt) in each 120 ml vial. This corresponds to 21.3% of the maximum recommended daily sodium intake in the diet for adults.

3. How to use Tobramycin B. Braun

Tobramycin B. Braun is administered by intravenous infusion directly into a vein.
The recommended administration time for the contents of one vial is 30 minutes, but it may be extended to 60 minutes.
Your doctor will determine the appropriate dose for you.
The following are the usual doses used.

Dosing in patients with normal kidney function

Adults and adolescents
Severe infections
3 mg of tobramycin per kg of body weight (bw) per day in one dose or 1 mg/kg bw in divided doses administered every 8 hours.
Life-threatening infections
Up to 5 mg of tobramycin per kg of body weight (bw) per day in one dose or 1.66 mg/kg bw in divided doses administered every 8 hours (or 1.25 mg/kg bw every 6 hours). As soon as the patient's clinical condition improves, the dose should be reduced.
Cystic fibrosis
Up to 8-10 mg of tobramycin per kg of body weight (bw) per day in divided doses.
Newborns and children over 1 week of age:
From 6 to 7.5 mg of tobramycin per kg of body weight (bw) per day in one dose or 2 to 2.5 mg/kg bw every 8 hours, or 1.5 to 1.9 mg/kg bw every 6 hours.
The dose and vial size the patient receives will depend on their body weight. Your doctor or nurse will ensure that the volume administered to the patient does not exceed the recommended dose. It is essential to be absolutely certain that the patient receives the correct dose.
The daily dose of tobramycin may be given as a single dose
This does not apply to patients with impaired immunity, kidney failure, a history of or symptoms indicating hearing loss, ascites, extensive burns (over 20% of skin surface), and pregnant women. Patients with normal kidney function will receive 5 mg/kg body weight in a single daily dose.

Dosing in patients with kidney function disorders

If the patient has kidney function disorders, the tobramycin concentration in the blood and kidney function will be carefully and frequently monitored to adjust the tobramycin dose accordingly. Your doctor knows how to calculate and adjust the doses you should receive.
If the patient is undergoing hemodialysis or peritoneal dialysis, the dose will be carefully selected based on the tobramycin concentration in the blood.

Patients with significant overweight

In these patients, the dose is calculated based on the estimated ideal body weight plus 40% of excess body weight.

Duration of treatment

Tobramycin treatment usually lasts 7-10 days. Longer treatment may be necessary in cases of severe and complicated infections. Kidney function, hearing, and balance will be monitored.

Using a higher dose of Tobramycin B. Braun than recommended

Overdose may lead to kidney damage or auditory nerve damage or muscle blockage (paralysis). In such cases, the tobramycin infusion should be discontinued. In patients with normal kidney function, your doctor will check if there is proper urine excretion. Tobramycin excretion can be forced by dialysis. Muscle blockage can be treated with calcium salts. If respiratory paralysis occurs, respiratory support may be necessary.
If an acute allergic reaction occurs, emergency measures should be taken.
If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In this leaflet, the frequency of side effects is defined as follows:
Very common:
occurs in more than 1 in 10 patients treated;
Common:
occurs in 1 to 10 in 100 patients treated;
Uncommon:
occurs in 1 to 10 in 1,000 patients treated;
Rare:
occurs in 1 to 10 in 10,000 patients treated;
Very rare:
occurs in less than 1 in 10,000 patients treated;
Frequency not known: frequency cannot be estimated from the available data.
Tobramycin is harmful to the auditory nerve and kidneys. Kidney function disorders have been uncommonly observed in patients treated with tobramycin. These disorders usually resolve after the medicine is discontinued.
In most cases, the harmful effect is related to an excessively high dose or prolonged treatment, already existing kidney disorders, or is related to other substances that also have a harmful effect on the kidneys. The occurrence of a harmful effect is more likely in the elderly and in patients with fluid deficiency. It is possible to avoid side effects to a significant extent by strictly following the precautions and careful dosing according to the instructions.

The following side effects, which may occur only rarely, may be severe and require immediate treatment:

• severe acute hypersensitivity reactions (allergic) with shock,
• hearing loss, which may develop into deafness,
• acute kidney failure.

Side effects that may be caused by treatment are listed below according to their frequency.
Common side effects

• Increased number of a certain type of white blood cell (eosinophilia).
• Inner ear damage in patients with kidney function disorders, manifested by dizziness, balance disorders, tinnitus, and hearing loss.
• Thrombophlebitis.
• Elevated bilirubin levels and certain liver enzymes (aspartate aminotransferase, alanine aminotransferase).
• Kidney damage in patients with kidney function disorders.
• Pain and local reactions at the injection site.

Uncommon side effects

• Low white blood cell count (leukopenia).
• Headache.
• Inner ear damage in patients with normal kidney function (same symptoms as above).
• Nausea, vomiting.
• Elevated bilirubin levels and liver enzyme activity (alkaline phosphatase, lactate dehydrogenase).
• Allergic skin rash, itching.
• Kidney damage in patients with normal kidney function.

Rare side effects

• Low red blood cell count, certain white blood cell count (granulocytopenia), and platelet count; elevated white blood cell count (leukocytosis).
• Allergic reactions (rash, itching, urticaria).
• Confusion, disorientation.
• Diarrhea.
• Redness of the skin.
• Fever, indifference.
• Low blood levels of calcium, magnesium, sodium, and potassium.

Very rare side effects

• Severe acute hypersensitivity reaction (allergic) up to shock.
• Severe allergic reaction involving the skin and mucous membranes, with blistering and redness of the skin (erythema multiforme), which can affect internal organs and take the form of a life-threatening reaction (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Acute kidney failure.

Side effects with unknown frequency

• Colitis (usually caused by other antibiotics), infection with bacteria resistant to tobramycin.
• Numbness, tingling of the skin, muscle tremors, seizures, drowsiness.
• Neuromuscular blockage.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration 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.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Tobramycin B. Braun

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and outer packaging. The expiry date refers to the last day of the month.
The abbreviation "EXP" means expiry date.
Only clear solutions without particles are suitable for use.
There are no special precautions for storage.
This medicine is for single use only.
Any unused solution should be discarded.
Medicines should not be disposed of via wastewater or household waste. Your pharmacist will know how to dispose of this medicine. This will help protect the environment.

6. Contents of the packaging and other information

What Tobramycin B. Braun contains

• The active substance is tobramycin. 1 ml of Tobramycin B. Braun, 1 mg/ml, solution for infusion contains 1 mg of tobramycin. 1 polyethylene vial of 80 ml contains 80 mg of tobramycin. 1 ml of Tobramycin B. Braun, 3 mg/ml, solution for infusion contains 3 mg of tobramycin. 1 polyethylene vial of 80 ml contains 240 mg of tobramycin. 1 polyethylene vial of 120 ml contains 360 mg of tobramycin.
• The other ingredients are: Tobramycin B. Braun, 1 mg/ml: Sodium chloride Water for injection Sulfuric acid (for pH adjustment)

Tobramycin B. Braun, 3 mg/ml:
Sodium chloride
Water for injection
Hydrochloric acid (for pH adjustment)

What Tobramycin B. Braun looks like and contents of the packaging

Tobramycin B. Braun is a solution for infusion, i.e. it is administered in the form of an infusion through a thin tube or cannula inserted into a vein.
This is a clear, colorless solution.
Tobramycin B. Braun, 1 mg/ml, solution for infusion is supplied in 80 ml polyethylene vials.
It is available in packs of 10 or 20 vials.
Tobramycin B. Braun, 3 mg/ml, solution for infusion is supplied in 80 ml or 120 ml polyethylene vials.
It is available in packs of 10 or 20 vials.

Marketing authorization holder

• B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany

Manufacturer

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

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria
Tobramycin B. Braun 1 mg/ml Infusionslösung
Tobramycin B. Braun 3 mg/ml Infusionslösung
Germany
Tobramycin B. Braun 1 mg/ml Infusionslösung
Tobramycin B. Braun 3 mg/ml Infusionslösung
Finland
Tobramycin B. Braun 1 mg/ml infuusioneste, liuos
Tobramycin B. Braun 3 mg/ml infuusioneste, liuos
Italy
Tobramicina B. Braun 1 mg/ml soluzione per infusione
Tobramicina B. Braun 3 mg/ml soluzione per infusione
Luxembourg
Tobramycin B. Braun 1 mg/ml Infusionslösung
Tobramycin B. Braun 3 mg/ml Infusionslösung
Norway
Tobramycin B. Braun 1 mg/ml Infusjonsvæske, oppløsning
Tobramycin B. Braun 3 mg/ml Infusjonsvæske, oppløsning
Poland
Tobramycin B. Braun, 1 mg/ml, solution for infusion
Tobramycin B. Braun, 3 mg/ml, solution for infusion

Date of last revision of the leaflet: 2021-11-11

_______________________________________________________________________________________

Information intended for healthcare professionals only:

Tobramycin B. Braun is a ready-to-use solution.
Under no circumstances should aminoglycosides be mixed in an infusion solution with beta-lactam antibiotics (e.g. penicillins, cephalosporins), as this may cause chemical-physical inactivation of the combined medicine. If tobramycin is administered together with penicillin or cephalosporin, both substances should be administered separately. For each medicinal product, the recommended dose should be used.
Tobramycin is incompatible with heparin.
For intravenous administration only.
For single use only.
Residual unused solution should be discarded.
Only clear solutions without particles are suitable for use.
From a microbiological point of view, the product should be used immediately. If not used immediately, the user is responsible for the storage conditions and duration before use. Under normal conditions, these should not exceed 24 hours of storage at 2-8°C.
The solution should be administered using sterile equipment and aseptic technique. The equipment should be prepared together with the solution to avoid air entering the system.
For detailed information on dosing, see section 4.2 of the Summary of Product Characteristics (SmPC).