Vantobra 170 mg solution for inhalation by nebulizer
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Vantobra 170 mg solution for inhalation by nebuliser
tobramycin
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Vantobra is and what it is used for
- What you need to know before using Vantobra
- How to use Vantobra
- Possible side effects
- How to store Vantobra
- Contents of the pack and other information
1. What Vantobra is and what it is used for
What Vantobra is
Vantobra contains an antibiotic called tobramycin. It belongs to a class of antibiotics known as aminoglycosides.
What Vantobra is used for
Vantobra 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.
Pseudomonas aeruginosa is a bacterium that frequently infects the lungs of patients with cystic fibrosis at some point in their lives. If the infection is not adequately treated, it continues to damage the lungs and causes worsening respiratory problems.
How Vantobra works
When inhaled, Vantobra delivers the antibiotic directly into the lungs to fight the bacteria causing the infection. This medicine works by disrupting the production of proteins that bacteria need to build their cell walls. This damages the bacteria and ultimately kills them.
2. What you need to know before using Vantobra
Do not use Vantobra:
- if you are allergic (hypersensitive) to tobramycin, or to any aminoglycoside antibiotic, or to any of the other components of Vantobra (listed in section 6).
If any of the above apply to you, inform your doctor before using Vantobra.
Warnings and precautions
Talk to your doctor if you have ever had any of the following conditions:
- hearing problems (including ringing in the ears and dizziness)
- kidney problems
- chest tightness
- blood in the sputum (the substance expelled when coughing)
- persistent or worsening muscle weakness over time, a symptom often associated with disorders such as myasthenia (muscle weakness) or Parkinson's disease.
If any of the above apply to you, inform your doctor before using Vantobra.
If you have hearing or kidney function problems, your doctor may take blood samples to monitor the amount of Vantobra in your body.
If you or members of your maternal family have a disease caused by a mitochondrial mutation (a genetic disorder) or hearing loss due to antibiotics, you are advised to inform your doctor or pharmacist before taking this medicine. Certain mitochondrial mutations may increase your risk of hearing loss with this product. Your doctor may recommend genetic testing before administration of Vantobra.
Inhalation of medications may cause chest tightness due to narrowing of the airways; this may occur with Vantobra. Your doctor may ask you to use other appropriate medications to widen the airways before using Vantobra.
Pseudomonas strains may become resistant to antibiotic treatment over time. This means that, over time, Vantobra may stop working as intended. If you have any concerns about this, speak with your doctor.
If you are also taking tobramycin or another aminoglycoside antibiotic administered by injection, this may increase the risk of adverse effects. Your doctor will monitor you as appropriate.
Children
This 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 using or have recently used any other medicines, including those obtained without a prescription.
You must not take the following medicines while using Vantobra:
-
furosemide, a diuretic (a medicine that increases urine volume)
-
other medicines with potential diuretic effects, such as urea or mannitol
-
other medicines that may damage your kidneys or hearing:
- amphotericin B, cephalothin, polymyxins (used to treat microbial infections), cyclosporine, tacrolimus (used to reduce the activity of the immune system). These medicines can damage the kidneys;
- platinum-based compounds, such as carboplatin and cisplatin (used to treat certain forms of cancer). These medicines can damage the kidneys or hearing.
The following medicines may increase the risk of harmful effects if administered while you are already receiving tobramycin or another aminoglycoside antibiotic by injection:
- anticholinesterases, such as neostigmine and pyridostigmine (used to treat muscle weakness), or botulinum toxin. These medicines may cause muscle weakness to appear or worsen.
If you are taking any of the above medicines, consult your doctor before using Vantobra.
Do not mix or dilute Vantobra with any other medicine in the hand-held nebulizer Tolero supplied with Vantobra.
If you are taking different medicines for cystic fibrosis, take them in the following order:
- Bronchodilator treatment, such as salbutamol
- Respiratory physiotherapy
- Other inhaled medicines
- Vantobra
Consult your doctor about the correct order.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
It is unknown whether inhaling this medicine during pregnancy may cause adverse effects. When administered by injection, tobramycin and other aminoglycoside antibiotics may cause harm to the fetus, such as deafness and kidney problems.
If you are breastfeeding, you should consult your doctor before using this medicine.
Driving and using machines
Vantobra is not expected to affect your ability to drive or operate machinery.
3. How to use Vantobra
Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor again.
The recommended dose is two ampoules per day (one in the morning and one in the evening) for 28 days.
- The dose is the same for all individuals aged 6 years and older.
- Inhale the full contents of one ampoule in the morning and another ampoule in the evening through the mouth using the Tolero handheld nebulizer.
- It is recommended that the interval between doses be as close as possible to 12 hours; in any case, this interval must be at least 6 hours.
- After using the medicine for 28 days, you will enter a 28-day rest period during which you will not inhale any Vantobra. After this rest period, you must start a new cycle (as illustrated below).
- It is important that you continue using the medicine twice daily for the full 28-day treatment period and that you follow the cycle of 28 days with treatment followed by 28 days without treatment.
Repeat the cycle
Continue using Vantobra according to this same schedule until your doctor tells you otherwise.
If you have any doubts about how long you should continue using Vantobra, consult your doctor or pharmacist.
Preparation of Vantobra for inhalation
- Use Vantobra only with the Tolero handheld nebulizer shown in the following image to ensure you inhale the correct dose. Do not use the Tolero handheld nebulizer with any other medicine.
- Read the instructions for use provided with the handheld nebulizer before using it.
- Make sure you have an eTrack or eBase controller to connect the Tolero handheld nebulizer to. The appropriate controller may be prescribed by your doctor or purchased separately.
- Wash your hands thoroughly with soap and water.
- Remove one Vantobra ampoule from the aluminum foil pouch immediately before inhalation.
- Store the remaining medicine refrigerated in the original carton.
- Place all parts of the Tolero handheld nebulizer on a clean, dry cloth or paper towel. Ensure the nebulizer is placed on a flat, stable surface.
- Assemble the Tolero handheld nebulizer as indicated in its instructions for use.
- Hold the ampoule upright and tap it gently before removing the top to prevent spillage. Empty the contents of one ampoule into the medication reservoir of the handheld nebulizer.
- Begin treatment by sitting upright in a well-ventilated room. Hold the nebulizer horizontally and breathe normally through your mouth. Avoid breathing through your nose. Continue breathing in and out comfortably until the treatment is complete. When the medication has been fully delivered, you will hear an audible signal indicating the end of administration.
- If, for any reason, you need to interrupt the treatment before completion, press and hold the On/Off button for one second. To resume treatment, press and hold the On/Off button for one second again.
- The Tolero handheld nebulizer must be cleaned and disinfected as described in the instructions for use.
- Use a new Tolero handheld nebulizer at the beginning of each treatment cycle (28 days of active treatment), as supplied with the medicine.
Do not use an alternative, untested nebulizer system, as this may alter the amount of medicine reaching the lungs, which could in turn affect the safety and efficacy of the medicine.
If you use more Vantobra than you should
If you inhale too much Vantobra, your voice may become very hoarse. Inform your doctor as soon as possible. If you swallow Vantobra, it is unlikely to cause serious problems, as tobramycin is poorly absorbed in the stomach; however, you should still inform your doctor as soon as possible.
If you forget to use Vantobra
If you forget to use Vantobra and there are at least 6 hours remaining before your next dose, take the missed dose as soon as possible. Otherwise, wait until your next scheduled dose. Do not use a double dose to make up for a missed dose.
If you stop using Vantobra
Do not stop using Vantobra unless instructed by your doctor, as the lung infection may not be adequately controlled and could worsen.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Some adverse effects can be serious
- chest discomfort with difficulty breathing (rare, may affect up to 1 in 1,000 people)
- allergic reactions, such as hives and itching (very rare, may affect up to 1 in 10,000 people)
If you experience any of these effects, stop using Vantobra and contact your doctor immediately.
People with cystic fibrosis have various symptoms of this disease. These symptoms may continue during treatment with Vantobra, but should not be more frequent or worse than before.
If your underlying lung condition appears to worsen while taking Vantobra, inform your doctor immediately.
Other adverse effects may include:
Uncommon (may affect up to 1 in 100 people)
- difficulty breathing
- voice alteration (hoarseness)
- increased frequency of coughing
- sore throat
Rare (may affect up to 1 in 1,000 people)
- Laryngitis (inflammation of the vocal cords which may cause voice changes, sore throat, and difficulty swallowing)
- Loss of voice
- Headache, weakness
- Nosebleed, nasal discharge
- Ringing in the ears (usually transient), hearing loss, dizziness
- Coughing up blood, producing more sputum than normal, chest discomfort, asthma, fever
- Taste disturbances, feeling of discomfort (nausea), mouth ulcers, malaise (vomiting), decreased appetite
- Rash
- Chest pain or generalized pain
- Worsening of pulmonary function test results
Very rare (may affect up to 1 in 10,000 people)
- Fungal infections in the mouth or throat, such as thrush
- Swelling of the lymph nodes
- Somnolence
- Ear pain, ear problems
- Hyperventilation, low blood oxygen levels, sinusitis
- Diarrhea, pain in or around the stomach
- Red pustules, skin papules
- Urticaria, pruritus
- Back pain
- General malaise
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Vantobra
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the ampoule, sachet, or carton, following «EXP». The expiry date refers to the last day of the month indicated.
Store in a refrigerator (between 2 °C and 8 °C). If a refrigerator is not available (for example, when transporting the medicine), the carton containing the medicine (even if the sachets are opened) may be stored below 25 °C for up to 4 weeks. If the medicine is stored at room temperature for more than 4 weeks, it must be discarded according to local regulations.
Do not use this medicine if it appears cloudy or if particles are visible in the solution.
Never store an opened ampoule. Once an ampoule is opened, it must be used immediately, and any remaining product must be discarded.
Medicines must not be disposed of via household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Vantobra
- The active substance is tobramycin. Each vial contains 170 mg of tobramycin as a single dose.
- The other components (excipients) are: sodium chloride, calcium chloride, magnesium sulfate, water for injections, sulfuric acid and sodium hydroxide to adjust the pH.
Appearance of Vantobra and contents of the pack
Vantobra for inhalation solution is supplied in a ready-to-use vial.
Vantobra is a clear to yellowish solution, which may vary in color up to dark yellow. This does not affect the efficacy of Vantobra as long as storage instructions have been followed.
The vials are packed in pouches, each pouch containing 8 vials, corresponding to four days of treatment.
Vantobra is available together with the Tolero handheld nebulizer. It is presented in a carton containing two inner boxes: one containing the medicinal product (56 vials of inhalation solution in 7 pouches) and the other containing the handheld nebulizer. One pack is sufficient for a 28-day treatment cycle.
Marketing Authorization Holder and Manufacturer
PARI Pharma GmbH
Moosstrasse 3
D-82319 Starnberg
Germany
Tel.: +49 (0) 89 – 74 28 46 - 10
Fax: +49 (0) 89 – 74 28 46 30
E-mail: [email protected]
Date of the most recent revision of this leaflet:
Other sources of information
Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu. Links to other websites on rare diseases and orphan medicinal products are also available.