Tobramycin via pharma

Package leaflet: Information for the patient

Tobramycin Via pharma, 300 mg/5 ml solution for nebulization
Tobramycin
Please read all of this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Tobramycin Via pharma is and what it is used for
2. What you need to know before using Tobramycin Via pharma
3. How to use Tobramycin Via pharma
4. Possible side effects
5. How to store Tobramycin Via pharma
6. Contents of the pack and other information

1. What Tobramycin Via pharma is and what it is used for

Tobramycin Via pharma is an aminoglycoside antibiotic.
Tobramycin Via pharma is used in patients with cystic fibrosis aged 6 years and older
for the treatment of lung infections caused by a bacterium called Pseudomonas aeruginosa.
Tobramycin Via pharma combats lung infections caused by Pseudomonas bacteria and helps the
patient to breathe more easily.
During inhalation of Tobramycin Via pharma, the antibiotic is delivered directly to the lungs to
fight the bacteria causing the infection. To achieve the best possible treatment outcome,
this medicine should be used exactly as instructed in this leaflet.

What is Pseudomonas aeruginosa?
Pseudomonas aeruginosa is a very common bacterium that, at some point in life, causes lung infection in nearly every patient with cystic fibrosis. Some patients become infected later in life, while others at a very early age.
It is one of the most harmful bacteria for people with cystic fibrosis. If the infection is not adequately treated, it may lead to progressive lung damage and worsening breathing problems.
Tobramycin Via pharma kills Pseudomonas bacteria responsible for lung infections. The infection can be effectively treated, especially if diagnosed early.

2. Important information before using Tobramycin Via pharma

When not to use Tobramycin Via pharma:

• If the patient is allergic to tobramycin or to any aminoglycoside antibiotic, or to any of the other ingredients of this medicine (listed in section 6).

If any of the conditions listed above apply to the patient, inform the
doctor before using Tobramycin Via pharma.
Warnings and precautions
Before starting treatment with Tobramycin Via pharma, discuss with the doctor or
pharmacist if the patient has ever had any of the following conditions:

• Hearing problems (including tinnitus and dizziness)
• Kidney disease
• Unusual breathing difficulties associated with wheezing or cough, chest tightness
• Blood in the sputum (expectorated mucus)
• Muscle weakness that persists or worsens over time; this symptom is most commonly associated with conditions such as myasthenia gravis or Parkinson's disease.

Inhaled medicines may cause chest tightness and wheezing; these symptoms may
occur after administration of Tobramycin Via pharma. The first dose of Tobramycin Via
pharma should be administered under medical supervision, and the doctor will assess lung function before and after administration of the dose. If the patient has not previously used a bronchodilator (e.g. salbutamol), the doctor may recommend using such a medicine before taking Tobramycin Via pharma.
When the patient is using Tobramycin Via pharma, Pseudomonas aeruginosa strains may over time become resistant to treatment. This may mean that the medicine may become less effective over time. If concerned, discuss this with the doctor.
Tobramycin administered by injection may occasionally cause hearing loss, dizziness,
kidney damage, and may also harm an unborn child.
Children and adolescents
Tobramycin Via pharma may be used in children and adolescents aged 6 years and older.
Tobramycin Via pharma should not be given to children under 6 years of age.
Tobramycin Via pharma and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not take the following medicines while using Tobramycin Via pharma:

• Furosemide (a diuretic)
• Urea or mannitol
• Other medicines that may damage the nervous system, kidneys, or hearing

The following medicines may increase the risk of adverse effects if administered at the same time as injections of tobramycin:

• Amphotericin B, cephalothin, cyclosporine, tacrolimus, polymyxins: these medicines may damage the kidneys.
• Platinum-containing compounds (such as carboplatin and cisplatin): these medicines may damage the kidneys or hearing.
• Cholinesterase inhibitors (such as neostigmine and pyridostigmine) or botulinum toxin: these medicines may cause occurrence or worsening of muscle weakness. If the patient is taking any of the above medicines, discuss this with the doctor before starting Tobramycin Via pharma.

Do not mix or dilute Tobramycin Via pharma with any other medicines
in the nebulizer.
If the patient is taking several different medicines for cystic fibrosis, the following
order should be followed:

1. bronchodilator, such as salbutamol
2. chest physiotherapy
3. other inhaled medicines
4. then Tobramycin Via pharma
   This order should be confirmed by consulting the doctor.

Pregnancy and breastfeeding
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.
It is not known whether inhaled use of Tobramycin Via pharma in pregnant women may
cause adverse effects.
Tobramycin and other aminoglycoside antibiotics administered by injection may harm
the unborn child, for example by causing deafness.
Driving and operating machinery
Tobramycin Via pharma is not expected to affect the ability to drive
or operate machinery.

3. How to use Tobramycin Via pharma

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor.

What dose and how often should Tobramycin Via pharma be used

• The recommended dose is the same for all patients aged 6 years and older.
• Use two ampoules per day for 28 days. Inhale the entire contents of one ampoule in the morning and one in the evening. It is best to maintain a 12-hour interval between doses.
• The interval between two consecutive doses of Tobramycin Via pharma must be at least 6 hours.
• After 28 days of treatment, a 28-day break follows, during which Tobramycin Via pharma is not taken. After the break, another treatment cycle begins.
• It is important to consistently use the medicine twice daily during the 28-day treatment period and to follow the cycle of 28 days of treatment and 28 days off treatment.

Taking Tobramycin Via pharma
Break from taking Tobramycin Via pharma
Take Tobramycin Via pharma daily, twice a day, for 28 days
Do not take Tobramycin Via pharma for the next 28 days

Repeat the cycle

Taking more Tobramycin Via pharma than recommended
If too high a dose of Tobramycin Via pharma is inhaled, severe hoarseness may occur. Inform your doctor as soon as possible. If Tobramycin Via pharma is accidentally swallowed, inform your doctor immediately.

Missing a dose of Tobramycin Via pharma
If a dose of Tobramycin Via pharma is missed and at least 6 hours remain before the next dose, take the missed dose as soon as possible. Otherwise, wait until the next scheduled dose. Do not use a double dose to make up for a missed dose.

Equipment needed for inhalation of Tobramycin Via pharma
Tobramycin Via pharma must be used with a clean and dry reusable nebulizer.
The LC PLUS nebulizer (manufactured by PARI GmbH) is suitable for administering Tobramycin Via pharma.
Your doctor or physiotherapist can instruct you on how to properly use Tobramycin Via pharma and which device is required. Different types of nebulizers may be needed for administering other medications used in cystic fibrosis.

Preparing for inhalation of Tobramycin Via pharma

• Wash hands thoroughly with soap and water.
• Each foil sachet contains 7 ampoules of Tobramycin Via pharma. To open the sachet, cut or tear it open. Remove one ampoule of Tobramycin Via pharma from the sachet. Return the remaining ampoules to the sachet and store them in the refrigerator.
• Lay out all parts of the nebulizer on a clean, dry paper towel or cloth.
• Check whether you have the appropriate compressor and connecting tubes to attach the nebulizer to the compressor.
• Carefully follow the operating instructions provided for your specific type of nebulizer. Read the leaflet supplied by the manufacturer. Before starting treatment, verify that the nebulizer and compressor are functioning properly according to the manufacturer's instructions.

Using Tobramycin Via pharma with the LC PLUS nebulizer (PARI GmbH)
More detailed information on using the nebulizer can be found in the leaflet provided with the PARI LC PLUS device.

1. Unscrew the top and bottom parts of the nebulizer by turning the top part counterclockwise, then lift it off. Place the top part aside on a towel and position the bottom part upright on the towel.
2. Connect one end of the tube to the outlet port of the compressor. Ensure the tube fits securely. Plug the compressor into an electrical outlet.
3. Open the Tobramycin Via pharma ampoule by holding its lower part with one hand and twisting and breaking off the top with the other hand. Squeeze the entire contents of the ampoule into the bottom part of the nebulizer.

4. Screw the top part of the nebulizer back onto the bottom part. Attach the mouthpiece and the inspiratory filter to the correct positions on the nebulizer. Then connect the compressor according to the instructions provided with the PARI LC PLUS nebulizer.
5. Turn on the compressor. Ensure a uniform mist is coming from the mouthpiece. If no mist is produced, check all connections and confirm that the compressor is working properly.
6. Sit or stand upright in a position that allows normal breathing.
7. Place the mouthpiece between your teeth, on your tongue. Breathe normally, but only through your mouth (nasal clips may be used if permitted by your doctor). Avoid blocking airflow with your tongue.

8. Continue until all of the Tobramycin Via pharma has been used and mist production stops. The entire dose should take approximately 15 minutes to inhale. After the nebulizer empties, a sputtering sound may be heard.

9. Remember to clean and disinfect the nebulizer after each use, according to the manufacturer's instructions. Never use a nebulizer that is dirty or clogged. The nebulizer is intended for personal use only and should not be shared with others.
If the treatment is interrupted, or if coughing or a break is needed during administration, turn off the compressor to save the remaining medication for later. Turn the compressor back on when the patient is ready to resume treatment. If less than 6 hours remain before the next scheduled dose, discard the remaining portion of the dose.

4. Possible adverse reactions

Like any medicine, Tobramycin Via pharma may cause adverse reactions, although they do not
occur in everyone.
Some adverse reactions may be serious.
If any of the symptoms listed below occur in the patient, treatment with Tobramycin Via pharma
must be discontinued and the physician must be informed immediately:

• unusual difficulty in breathing, with wheezing or coughing and chest tightness
• allergic reactions, including hives and itching (very rare)

If any of the following symptoms occur in the patient, the physician must be informed
immediately:

• hearing loss (ringing in the ears may be an early sign of hearing loss), noises (such as buzzing) in the ears

The patient's underlying lung disease may worsen during treatment with Tobramycin Via pharma.
This may be due to lack of treatment effectiveness. If this occurs, the physician must be informed
immediately.
Some adverse reactions are very common
They may affect more than 1 in 10 patients

• nasal discharge or sensation of nasal congestion, sneezing
• voice changes (hoarseness)
• change in color of expectorated sputum
• worsening of lung function test results
  If any of these symptoms are significantly intensified, the physician should be informed.

Some adverse reactions are common
They may affect less than 1 in 10 patients

• general malaise
• muscle pain
• voice change with sore throat and difficulty swallowing (laryngitis)
  If any of these symptoms are significantly intensified, the physician should be informed.

Other adverse reactions:

• itching
• itchy rash
• rash
• loss of voice
• taste disturbances
• sore throat
  If any of these symptoms are significantly intensified, the physician should be informed.

Hearing loss as an adverse reaction has been reported when Tobramycin Via pharma was used
concurrently with or following multiple cycles of treatment with tobramycin or another
aminoglycoside antibiotic administered by injection.
Administration of tobramycin or other aminoglycosides by injection may cause allergic reactions,
hearing problems, and kidney problems.
Patients with cystic fibrosis may experience multiple disease-related symptoms. These symptoms
may persist during treatment with Tobramycin Via pharma, but should not occur more frequently
or become more severe than before.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, the
physician or pharmacist should be informed. Adverse reactions can be reported directly to the
Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal
Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel. +48 22 49 29 301
Fax: +48 22 49 29 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tobramycin Via pharma

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, outer packaging, or ampoule. The expiry date refers to the last day of the stated month.
Do not use Tobramycin Via pharma if cloudiness or particles are observed in the solution.
Store in a refrigerator (2°C - 8°C). If a refrigerator is not available (for example, during transport of the medicine), the product in its foil sachet (intact or opened) may be stored at room temperature (not exceeding 25°C) for up to 28 days.
Do not use Tobramycin Via pharma if the ampoules have been stored at room temperature for longer than 28 days.
Tobramycin Via pharma is usually light yellow in colour, but its shade may vary and sometimes appear darker. This does not affect the properties of Tobramycin Via pharma, provided it has been stored according to the recommended conditions.
An opened ampoule must never be stored. After opening, the ampoule should be used immediately and any remaining solution must be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the package and other information

What Tobramycin Via pharma contains

• The active substance is tobramycin. One 5 ml vial contains 300 mg of tobramycin, which constitutes a single dose of the medicine.
• The other ingredients are: sodium chloride, water for injections, sodium hydroxide 1N and sulfuric acid 2N (to adjust the solution's acidity).

What Tobramycin Via pharma looks like and contents of the pack
Tobramycin Via pharma is a clear, light yellow solution in ready-to-use vials.
Vials are packed in foil sachets. One foil sachet contains 7 vials.
Tobramycin Via pharma is available in packs containing 56 vials. This quantity
is sufficient for one treatment cycle.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
UAB Via pharma
J.Galvydžio g. 5
LT-08236 Vilnius
Lithuania
Manufacturer:
MEDICHEM S.A
Narcís Monturiol, 41 A
Sant Joan Despí, 08970 Barcelona
Spain
The medicinal product is available in the European Economic Area countries under the following names: