VANTOBRA 170 mg Solution For Nebulization

Зміст інструкції

1. Vantobra 170 mg solution for nebulizer
   1. What is Vantobra and what is it used for
   2. What you need to know before using Vantobra
   3. How to use Vantobra
   4. Possible side effects
   5. How to store Vantobra
   6. Contents of the pack and other information

Vantobra 170 mg solution for nebulizer

Tobramycin

Read this leaflet carefully before using 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Vantobra and what is it used for

What is Vantobra
Vantobra contains a medicine called tobramycin. It belongs to a group of antibiotics called
aminoglycosides.

What is Vantobra used for
Vantobra is used in patients with cystic fibrosis who are at least 6 years of age, for the treatment of
lung infections caused by bacteria called Pseudomonas aeruginosa.

Pseudomonas aeruginosais a bacterium that frequently infects the lungs of patients who suffer from
cystic fibrosis during their life. If the infection is not treated correctly, it continues to
damage the lungs, causing further breathing problems.

How Vantobra works
When Vantobra is inhaled, the antibiotic is able to penetrate directly into the lungs and fight the
bacteria that cause the infection. The antibiotic works by interfering with the production of the proteins that
bacteria need to create their cell walls. This damages the bacteria until it kills them.

2. What you need to know before using Vantobra

Do not use Vantobra

• if you are allergic to tobramycin, to any type of aminoglycoside antibiotic or to any of the other ingredients of this medicine (listed in section 6). If this applies to you, inform your doctor before using Vantobra.

Warnings and precautions
Consult your doctor if you have ever suffered from the following conditions:

• hearing problems (including ringing in the ears and dizziness)
• kidney problems
• chest tightness
• presence of blood in the sputum (the substance produced with coughing)
• prolonged or worsening muscle weakness - a symptom mainly related to conditions such as myasthenia (muscle weakness) or Parkinson's disease. If you are in any of these situations, inform your doctor before using Vantobra.

If you have hearing or kidney problems, your doctor may take blood samples to check
the amount of Vantobra present in your body.
If you or your maternal relatives have a mitochondrial mutation disease (a genetic disease) or hearing loss
caused by antibiotics, we advise you to inform your doctor or pharmacist before taking
this medicine; some mitochondrial mutations may increase the risk of hearing loss with
this medicine. Your doctor may recommend genetic testing before administering
Vantobra.
Inhalation of medicines can cause a feeling of chest tightness due to narrowing of the airways,
and this can happen with Vantobra. Your doctor may ask you to use other appropriate medicines
to dilate the airways before using Vantobra.
Over time, some strains of Pseudomonasmay become resistant to treatment with an
antibiotic. This means that, over time, the effectiveness of Vantobra may be reduced. Inform your doctor
if this worries you.
If you are also taking tobramycin or another aminoglycoside antibiotic by injection, this could
increase the risk of side effects and your doctor will perform appropriate checks.

Children
The medicine is not intended for use in children under 6 years of age.

Other medicines and Vantobra
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Do not take the following medicines while you are using Vantobra:

• furosemide, a diuretic
• other medicines that may be diuretic, such as urea or mannitol
• other medicines that can damage the kidneys or hearing: such as amphotericin B, cefalotin, polymyxins (for the treatment of microbial infections), cyclosporine, tacrolimus (to reduce the activity of the immune system). These medicines can damage the kidneys. or platinum compounds, such as carboplatin and cisplatin (for the treatment of some types of cancer). These medicines can damage the kidneys or hearing.

The following medicines may increase the risk of side effects if they are administered to you while
you are also taking tobramycin or another aminoglycoside antibiotic administered by injection:

• anticholinesterases, such as neostigmine and pyridostigmine (for the treatment of muscle weakness), or botulinum toxin. These medicines can lead to the appearance of muscle weakness or its worsening. If you are taking one or more of the aforementioned medicines, inform your doctor before using Vantobra.

Do not mix or dilute Vantobra with other medicines inside the Tolero nebulizer mouthpiece, provided
with Vantobra.
If you are following various different therapies for cystic fibrosis, you should take them in this order:

• 1. Bronchodilator therapy, such as salbutamol
• 2. Chest physiotherapy
• 3. Other inhalation medicines
• 4. Vantobra Check this order also with your doctor.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with milk
ask your doctor for advice before using this medicine.
It is not known whether inhalation of this medicine during pregnancy may cause adverse effects.
When administered by injection, tobramycin and other aminoglycoside antibiotics can
harm the fetus, for example causing deafness and kidney problems.
If you are breastfeeding, talk to your doctor before using this medicine.

Driving and operating machinery
Vantobra is not expected to affect your ability to drive or operate machinery.

3. How to use Vantobra

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor.
The recommended dose is two vials per day (one in the morning and one in the evening) for 28 days.

• The dose is identical for all people aged 6 years and over.
• Inhale the entire contents of one vial through your mouth in the morning, and of one vial in the evening, using the Tolero nebulizer mouthpiece.
• It is advisable that 12 hours pass between doses, but this interval must still be at least 6 hours.
• After using the medicine for 28 days, you will stop taking it for another 28 days and during this period you will not inhale Vantobra. Afterwards, you will start another cycle after the break period (as shown).
• It is important that you continue to use the medicine twice a day for the 28 days of treatment, and that you respect the 28 days of treatment / 28 days without treatment regimen.

IN TREATMENT with Vantobra NOT IN TREATMENT with Vantobra
Use Vantobra twice a day for 28 days Do not use Vantobra for the next 28 days

Repeat the cycle
Continue to use Vantobra in this cyclic way, until your doctor tells you to do so.
If you have any doubts about the duration of Vantobra use, consult your doctor or pharmacist.

How to prepare Vantobra for inhalation

• Use Vantobra exclusively with the Tolero nebulizer mouthpiece shown in the illustration below, to ensure you inhale the correct dose. Do not use the Tolero nebulizer mouthpiece for any other medicine.
• Read the instructions for use provided with the nebulizer mouthpiece before using it.

• Check that you have an eTrack or eBase Controller unit to connect the Tolero nebulizer mouthpiece to. The respective control unit can be prescribed by your doctor or purchased separately.
• Wash your hands thoroughly with soap and water.
• Remove a vial of Vantobra from the aluminum pouch just before inhalation.
• Store the remaining medicine in the refrigerator, in the original box.
• Place all the components of the Tolero nebulizer mouthpiece on clean, dry paper towels or a fabric cloth. Make sure the nebulizer mouthpiece is on a flat, stable surface.
• Assemble the Tolero nebulizer mouthpiece as illustrated in the device's instructions for use.
• Hold the vial in an upright position and tap it gently before breaking the top, to avoid spills of medicine. Pour the contents of one vial into the medicine container on the nebulizer mouthpiece.
• Start the treatment by sitting with your back straight, in a well-ventilated room. Hold the nebulizer mouthpiece horizontally and breathe normally through your mouth. Avoid breathing through your nose. Continue to inhale and exhale without effort, until the end of the treatment. When all the medicine has been administered, you will hear an audible signal confirming that the treatment is complete.
• If for any reason you need to interrupt the treatment, press and hold the On/Off power button for a whole second. To resume treatment, press and hold the On/Off power button again for a whole second.
• The Tolero nebulizer mouthpiece must be cleaned and disinfected as described in the device's instructions for use.
• Use a new Tolero nebulizer mouthpiece for each treatment cycle (28 days of treatment), as provided with the medicine.

Do not use other nebulization systems that have not been tested, as they may alter the amount of medicine that
reaches the lungs. This in turn may alter the degree of efficacy of the medicine and its safety.

If you use more Vantobra than you should
If you inhale an excessive amount of Vantobra, your voice may become very hoarse. Inform your doctor
as soon as possible. If Vantobra is ingested, it is unlikely to cause serious problems, as tobramycin
is poorly absorbed by the stomach. However, inform your doctor as soon as possible anyway.

If you forget to use Vantobra
If you forget to use Vantobra and at least 6 hours remain before taking the next dose, use your
dose as soon as possible. Otherwise, wait until the next dose. Do not use a double dose to
make up for a missed dose.

If you stop the treatment with Vantobra
Do not stop using Vantobra unless your doctor tells you to do so, as your lung infection
may not be sufficiently under control and may worsen.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects may be serious

• chest tightness with difficulty breathing (rare, affects up to 1 in 1,000 people)
• allergic reactions, including hives and itching (very rare, affects up to 1 in 10,000 people). If you experience any of these disorders, stop using Vantobra and inform your doctor immediately.

People affected by cystic fibrosis may have many symptoms of the disease. These symptoms may also
occur during the use of Vantobra, but they should not be as frequent or worse than
before.
If your initial lung disease seems to worsen during treatment with Vantobra, inform your
doctor immediately.
Other side effects may include:
Uncommon (may affect up to 1 in 100 people)

• shortness of breath
• change in voice (hoarseness)
• increased cough
• sore throat

Rare (may affect up to 1 in 1,000 people)

• laryngitis (inflammation of the larynx which can cause change in voice, sore throat and difficulty swallowing)
• loss of voice
• headache, weakness
• nosebleed, runny nose
• ringing in the ears (usually transient), hearing loss, dizziness
• bloody cough, production of more sputum than usual, chest discomfort, asthma, fever
• altered taste, nausea, mouth ulcers, vomiting, loss of appetite
• skin rash
• chest or generalized pain
• worsening of lung function test results

Very rare (may affect up to 1 in 10,000 people)

• fungal infections of the mouth or throat, such as thrush
• swelling of the lymph nodes
• drowsiness
• earache, ear problems
• hyperventilation, low blood oxygen levels, sinusitis
• diarrhea, pain inside and around the stomach
• appearance of red pustules, papules on the skin
• hives, itching
• back pain
• feeling generally unwell

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system listed in Annex V. By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Vantobra

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the vial, sachet or carton
after Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2ºC – 8ºC). If you do not have a refrigerator (for example when you are transporting the
medicine), you can store the pack with the medicine (even if the sachets are open) at
a temperature below 25°C for a maximum of 4 weeks. If the medicine has been stored at
room temperature for more than 4 weeks, it must be discarded in accordance with current local regulations.
Do not use this medicine if you notice that it has become cloudy, or if the solution contains particles.

Never store an opened vial. After opening, the vial must be used immediately and
any remaining product must be discarded.
Do not dispose of any medicine in household waste. Ask your pharmacist how to eliminate medicines that you
no longer use. This will help to protect the environment.

6. Contents of the pack and other information

What Vantobra contains

• The active substance is tobramycin. One vial contains 170 mg of tobramycin as a single dose.
• The other ingredients are: sodium chloride, calcium chloride, magnesium sulfate, water for injections, sulfuric acid and sodium hydroxide for pH adjustment.

Description of the appearance of Vantobra and contents of the pack
Vantobra solution for nebulizer is supplied inside a ready-to-use vial.
Vantobra is a colorless to slightly yellow solution, and its color may vary to a darker yellow.
This does not change the way Vantobra works, provided the storage instructions have been
respected.
Eight vials are packaged inside a sachet corresponding to four days of treatment.
Vantobra is available together with the Tolero nebulizer mouthpiece. It is supplied in a box, containing in
turn two inner boxes: one with the medicinal product (56 vials of solution for nebulizer, in 7 sachets) and
one with the nebulizer mouthpiece. One pack is sufficient for a treatment cycle of 28 days.

Marketing authorisation holder and manufacturer
PARI Pharma GmbH
Moosstrasse 3
82319 Starnberg
Germany
Tel.: +49 (0) 89 – 74 28 46 - 10
Fax: +49 (0) 89 – 74 28 46 30
E-Mail: [email protected]

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu. Furthermore, links to other websites on rare diseases and related
therapeutic treatments are provided.