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The product code(s) for this leaflet is: PLGB 32288/0006.
Vantobra 170mg nebuliser solution
Vantobra 170 mg nebuliser solution
tobramycin
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
Vantobra contains an antibiotic medicine called tobramycin. It belongs to a class of antibiotic medicines called aminoglycosides.
Vantobra is used in patients with cystic fibrosis aged 6 years and older to treat lung infections caused by bacteria named Pseudomonas aeruginosa.
Pseudomonas aeruginosa is a bacterium that frequently infects the lungs of cystic fibrosis patients at some time during their lives. If the infection is not properly treated, it continues to damage the lungs, causing further problems with breathing.
When you inhale Vantobra, the antibiotic can enter directly into your lungs to fight the bacteria causing the infection. It works by disrupting the production of proteins that the bacteria need to build their cell walls. This damages the bacteria and eventually kills them.
If this applies to you, tell your doctor before using Vantobra.
Talk to your doctor if you have ever had any of the following conditions:
If any of these apply to you, tell your doctor before using Vantobra.
If you have problems with your hearing or kidney function, your doctor may take blood samples to monitor the amount of Vantobra in your system.
If you or your maternal family members have a mitochondrial mutation disease (a genetic condition) or loss of hearing due to antibiotic medicines, you are advised to inform your doctor or pharmacist before you take 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.
Inhaling medicines can cause 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 widen the airways before using Vantobra.
Strains of Pseudomonas can become resistant to treatment with an antibiotic over time. This means that Vantobra may not work as well as it should over time. Talk to your doctor if you are concerned about this.
If you are also taking tobramycin or another aminoglycoside antibiotic by injection, it may increase the risk of side effects and your doctor will monitor for these as appropriate.
The medicine is not intended for use in children under 6 years of age.
Tell your doctor or a pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
You should not take the following medicines while you are using Vantobra:
The following medicines can increase the risks of harmful effects occurring if they are given to you while you also take tobramycin or another aminoglycoside antibiotic given by injection:
If you are taking one or more of the above medicines, talk to your doctor before you use Vantobra.
You should not mix or dilute Vantobra with any other medicine in your Tolero nebuliser handset which is provided together with Vantobra.
If you are taking several different treatments for cystic fibrosis, you should take them in the following order:
1. Bronchodilator therapy, such as salbutamol
2. Chest physiotherapy
3. Other inhaled medicines
4. Vantobra
Please check this order with your doctor as well.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
It is not known whether inhaling this medicine while you are pregnant causes side effects. When they are given by injection, tobramycin and other aminoglycoside antibiotics can cause harm to an unborn child, such as deafness and kidney problems.
If you are breast feeding, you should talk to your doctor before using this medicine.
Vantobra is not expected to affect your ability to drive or use machines.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
The recommended dose is two ampoules each day (one in the morning and one in the evening) for 28 days.
Continue using Vantobra on this cyclical basis for as long as your doctor tells you.
If you have questions about how long to use Vantobra, talk to your doctor or pharmacist.
Do not use an alternative untested nebuliser system because it may alter the amount of medicine reaching the lungs. This in turn may alter how well the medicine works and its safety.
If you inhale too much Vantobra you may get a very hoarse voice. Tell your doctor as soon as possible. If Vantobra is swallowed, it is unlikely to cause severe problems as tobramycin is poorly absorbed from the stomach, but you should still tell your doctor as soon as possible.
If you forget to use Vantobra and there are at least 6 hours to your next dose, use your dose as soon as you can. Otherwise, wait for your next dose. Do not use a double dose to make up for a forgotten dose.
Do not stop using Vantobra unless your doctor tells you to do so, as your lung infection may not be controlled sufficiently and may become worse.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of these, stop using Vantobra and tell your doctor straight away.
People with cystic fibrosis have many symptoms of the disease. These may still occur while using Vantobra, but should not be as frequent or worse than before.
If your underlying lung disease seems to become worse while you are using Vantobra, tell your doctor straight away.
Other side effects may include:
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the ampoule or the sachet or box after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). If you don’t have a refrigerator available (such as when you are transporting your medicine) you can store the box with the medicine (sachets opened or unopened) below 25°C for up to 4 weeks. If the product has been stored at room temperature for longer than 4 weeks, it has to be disposed according to local requirements.
Do not use this medicine if you notice that it has become cloudy, or if there are particles in the solution.
Never store an opened ampoule. Once opened an ampoule should be used immediately, and any remaining product should be discarded.
Do not throw away any medicines via household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Vantobra nebuliser solution is provided in a ready-to-use ampoule.
Vantobra is a clear to slightly yellow coloured solution which can vary to a darker yellow. This does not change how Vantobra works provided that the storage instructions have been followed.
Ampoules are packed in sachets, one sachet contains 8 ampoules which correspond with 4 days of treatment.
Vantobra is available together with a Tolero nebuliser handset. It is supplied in a box that contains two inner boxes, one with the medicine (56 ampoules with nebuliser solution in 7 sachets), and one with the nebuliser handset. A package is sufficient for one treatment cycle of 28 days.
This leaflet was last revised in
June 2023