300 mg/5 ml solution for nebulizer
What Tobi is and what it is used for
What is Tobi?
Tobi contains tobramycin. It is an antibiotic that belongs to the group of aminoglycosides.
Tobi is used in patients from the age of six with cystic fibrosis to treat lung infections caused by a bacterium called Pseudomonas aeruginosa.
Tobi treats infection in the lungs caused by the Pseudomonas bacteria and helps to facilitate breathing.
When you inhale Tobi, the medicine goes directly into the lungs where it kills the bacteria that caused the infection. For the best effect of the medicine, follow the instructions in this information.
What is Pseudomonas aeruginosa ?
This is a very common bacteria that affects almost everyone with cystic fibrosis at some point in their lives. Some get an infection later in life, while others get it at a very young age.
It is one of the most harmful bacteria for people with cystic fibrosis. If an infection is not treated properly, it can continue to damage the lungs, leading to further breathing problems.
Tobi kills the bacteria that caused the lung infection. If treatment is started at an early stage, the infection can be treated with good results.
What you need to know before using Tobi
Do not use Tobi:
- if you are allergic to tobramycin, any aminoglycoside antibiotic, or any of the other ingredients of this medicine (listed in section 6).
If any of the above applies to you, do not take this medicine without consulting your doctor. Consult your doctor if you think you are allergic.
Warnings and precautions
Consult a doctor before using Tobi if you have or have ever had any of the following problems:
- Hearing problems (including ringing in the ears and dizziness).
- Kidney problems.
- Unusual difficulty breathing with wheezing or coughing, chest tightness.
- Bloody mucus (when expectorated).
- Muscle weakness that is persistent or worsens over time, symptoms mainly associated with myasthenia (muscle weakness) or Parkinson’s disease
If any of the above apply to you, tell your doctor before using Tobi.
Inhalation of medications can cause spasms in the trachea and wheezing, which can also occur with Tobi. The doctor will be with you when you take the first dose and examine the lung function before and after dosing. If you are not already using an airway dilator, the doctor may prescribe one (eg salbutamol ) before you take Tobi.
When using Tobi, Pseudomonas strains may become resistant to the treatment over time. This means that the medicine no longer works as well as it should. Talk to your doctor if this is something that worries you.
If you receive tobramycin by injection, it can cause deafness, dizziness, kidney damage, and lead to birth defects.
Children and young people
Tobi can be taken by children and young people aged 6 and over. Tobi should not be given to children under 6 years of age.
If you are 65 years of age or older, your doctor may perform additional tests to determine if Tobi is the right treatment for you.
Other medicines and Tobi
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
You should not take the following medicines during treatment with Tobi:
- furosemide or ethacrynic acid , diuretics
- mannitol is given intravenously or urea
- other medicines that can damage the nervous system, kidneys, or hearing.
The following medicines may increase the risk of side effects occurring if they are given when you are receiving tobramycin injection at the same time :
- amphotericin B, cephalothin, cyclosporine, tacrolimus, and polymyxins: these medicines can damage the kidneys.
- medicines containing platinum (eg carboplatin and cisplatin): these medicines can damage the kidneys and hearing.
- cholinesterase inhibitors (eg neostigmine and pyridostigmine) or botulinum toxins: these medicines can cause or worsen muscle weakness.
If you are using one or more of the above medicines, consult your doctor before using Tobi.
Tobi must not be mixed or diluted with any other medicine in the nebulizer.
If you have several different medicines for cystic fibrosis, you should take them in the following order:
- bronchodilators eg salbutamol
- breathing exercises
- other inhaled medicines
- then Tobi.
Also, check the order with the doctor.
Pregnancy and breastfeeding
If you are trying to become pregnant or are pregnant, you should consult the doctor about the possible risk that this medicine could harm you or the fetus.
It is not known whether inhalation of the drug causes birth defects during pregnancy.
When given by injection, tobramycin and other aminoglycoside antibiotics can cause birth defects such as deafness.
If you are breastfeeding, you should talk to your doctor before taking the medicine.
Driving ability and use of machinery
Tobi should not affect your ability to drive or use machines.
How to use Tobi
Always use this medicine as directed by your doctor. Consult a doctor if you are unsure.
- The recommended dose is the same for everyone from the age of 6.
- Use two ampoules daily for 28 days. Inhale the entire contents of one ampoule in the morning and one in the evening. The doses should preferably be taken 12 hours apart.
- At least 6 hours must pass between two Tobi inhalations.
- After you have taken the medicine for 28 days, 28 treatment-free days follow when you do not take the medicine, before you start a treatment period again.
- It is important that you take the medicine twice a day during the treatment period and that you follow the 28-day interval with or without treatment.
If you have taken too much Tobi
If you have inhaled too much Tobi, you may become hoarse. Tell the doctor about this as soon as possible. If you accidentally swallow Tobi, tell your doctor as soon as possible.
If you forget to take Tobi
If you forget to take Tobi and it is at least 6 hours until the next dose, take dose one as soon as you can, otherwise, you will skip dose one. Do not take a double dose to make up for a missed dose.
Instructions for using Tobi
This section of the leaflet explains how Tobi should be used and handled. Read through and follow these instructions carefully.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Equipment for inhalation of Tobi
Tobi should be used with a clean and dry reusable nebulizer.
The LC PLUS nebulizer (manufactured by PARI GmbH) is suitable for use with Tobi.
A doctor or physiotherapist can advise you on how to use Tobi correctly and on the equipment you need. You may need different nebulizers for your other inhaled medicines for cystic fibrosis.
Preparation for inhalation of Tobi
- Wash hands thoroughly with soap and water.
- Each foil bag contains a tray with 14 ampoules. Cut or tear open the bag. Remove an ampoule from the tray by gently pulling it apart from the other attached ampoule by the tabs on the outer edge. Put the tray back in the foil bag and put it in the fridge.
- Place the nebulizer parts on a clean, dry piece of paper or a towel.
- Make sure you have a compressor that fits and hoses to connect the nebulizer to the compressor.
- Follow the instructions for the nebulizer carefully. You must read the information provided by the manufacturer of the nebulizer. Check that the nebulizer and compressor are working according to the manufacturer’s instructions before you start taking the medicine.
Use of Tobi with LC PLUS (PARI GmbH)
For more detailed instructions on the use of the nebulizer, read the instructions that come with PARI LC PLUS.
If you are interrupted or need to cough or rest during treatment, turn off the compressor to save the medicine. Turn the compressor back on as soon as you are ready to continue. If it is less than 6 hours until your next regular dose, skip this dose.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious
If you experience any of the following, stop taking Tobi and contact your doctor immediately:
- Unusually difficult breathing with wheezing or coughing and chest tightness.
- Allergic reactions include hives and itching.
If you get any of the following, see a doctor immediately:
- Hearing loss (ringing in the ears is a potential warning sign of hearing loss), noises (eg hissing) in the ears.
The underlying lung disease may worsen while taking Tobi. This may be due to a lack of power. Talk to your doctor immediately if this happens.
Some side effects are very common
These side effects occur in more than 1 in 10 people.
- Runny or stuffy nose, sneezing
- Voice changes (hoarseness)
- Discoloration of the expectorated mucus
- Impaired pulmonary function tests
If any of these side effects affect you seriously, contact a doctor.
Some side effects are common
These side effects occur in up to 1 in 10 people.
- General malaise
- Muscle pain
- Voice changes with a sore throat and difficulty swallowing (throat inflammation)
If any of these side effects affect you seriously, contact a doctor.
Other side effects:
- Itchy rash
- Loss of voice
- Taste changes
- Sore throat
If any of these symptoms affect you seriously, consult a doctor.
If you have received Tobi at the same time as the injection of tobramycin or another aminoglycoside antibiotic, or after repeated injection treatments, hearing loss has been reported as a side effect. Injection with tobramycin or other aminoglycoside antibiotics can cause allergic reactions, hearing problems, and kidney problems.
People with cystic fibrosis have several symptoms of the disease. These may persist when Tobi is used, but should not occur more frequently or worsen compared to before.
How Tobi should be stored
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date stated on the packaging, bag, or ampoule.
- Do not use this medicine if the solution becomes cloudy or if there are particles in the solution.
- Store at 2-8°C ( in a refrigerator ). If a refrigerator is not available (e.g. when transporting the medicine), you can store the foil bags (opened or unopened) at room temperature (at a maximum of 25°C) for a maximum of 28 days.
- Do not use Tobi ampoules that have been stored at room temperature for longer than 28 days.
- Keep the ampoules in the original packaging as this medicine is sensitive to strong light. This medicine is normally pale yellow, but the color can vary slightly and can sometimes be a darker yellow. However, this does not affect the effectiveness of this medicine provided that the storage instructions have been followed.
Never save an opened ampoule. Once an ampoule has been opened, it should be used immediately and any remaining amount should be discarded.
Contents of the packaging and other information
- The active substance is tobramycin. One ampoule contains 300 mg tobramycin as a single dose.
- Other ingredients are sodium chloride, water for injections, sodium hydroxide, and sulfuric acid (for pH adjustment ).
Appearance and package sizes of the medicine
Tobi is a clear, slightly yellow solution supplied in ampoules.
The ampoules are packed in foil bags. A foil bag contains 14 ampoules, which corresponds to 7 days of treatment.
Tobi is supplied in packs of 56, 112, and 168 ampoules, which correspond to one, two, and three treatment periods respectively.
Not all pack sizes may be marketed.
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Viatris AB, Box 23033 104 35 Stockholm
McDermott Laboratories Ltd T/A Mylan Dublin
Unit 25 Baldoyle Industrial Estate
Grange Road, Baldoyle
Dublin 13, D13 N5X2
Mylan Germany GmbH
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