What is Vantobra - tobramycin and what is it used for?
Vantobra is an antibiotic indicated for the treatment of chronic lung infection caused by the Pseudomonas aeruginosa bacteria in patients from six years of age with cystic fibrosis. Cystic fibrosis is a hereditary disease in which an accumulation of thick mucus is observed in the lungs, which allows bacteria to multiply more easily, causing infections. Lung infection caused by P. aeruginosa bacteria is common in patients with cystic fibrosis. Before using Vantobra, doctors should consider official guidelines on the correct use of antibiotics. Vantobra is a "hybrid" medicine. It contains the active substance tobramycin, which is the same active ingredient as the reference medicine, Tobi. Both medicines are available as a nebulizer solution. However, the concentration of active ingredient present in Vantobra is greater than in Tobi and the medicine is inhaled with a different nebulizer.
How is Vantobra - tobramycin used?
Vantobra is available as a nebulizer solution in single-dose vials called "ampoules". The medicine can only be obtained with a prescription. Vantobra is inhaled through a nebuliser called Tolero, which transforms the solution of the vial into aerosol with very fine drops. The medicine should not be inhaled with other devices. Vantobra EMA / 169512/2015 Page 2/3 The recommended dose is one ampoule twice a day, possibly at an interval of 12 hours. After 28 days of treatment, therapy should be interrupted for 28 days before starting a new cycle. The cycles can be repeated until the doctor believes that the patient benefits from it. If the patient is subjected to other inhalation treatments or to chest therapy, it is recommended to use Vantobra last.
How does Vantobra - tobramycin work?
The active ingredient present in Vantobra, tobramycin, is an antibiotic belonging to the group of "aminoglycosides". It works by blocking the production of proteins that P. aeruginosa needs to build its cell walls, thus causing damage to the bacteria until it is eliminated.
What benefit has Vantobra - tobramycin shown during the studies?
Tobramycin has been used for some years in the treatment of P. aeruginosa infections in patients with cystic fibrosis. In support of the use of Vantobra the applicant presented data taken from the literature. In addition, the applicant conducted a "bioequivalence" study on 58 patients with cystic fibrosis from 6 years of age to determine whether Vantobra produces levels of the active substance similar to the reference medicine, Tobi. The results of the study showed that Vantobra can be considered comparable to Tobi.
What is the risk associated with Vantobra - tobramycin?
The side effects of Vantobra are not common. However, the following side effects are seen in between 1 and 10 patients in 1 000: dyspnoea (difficulty breathing), dysphonia (voice changes), pharyngitis (sore throat) and cough. For the full list of side effects and limitations, see the package leaflet.
Why has Vantobra - tobramycin been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vantobra's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP noted that inhalation of tobramycin is the best practice for the treatment of P. aeruginosa infection in patients with cystic fibrosis and that some individuals cannot use the dry powder formulation for intolerance problems. For these patients, Vantobra, which is inhaled as a nebuliser solution, could be a viable alternative. Furthermore, the time needed to inhale Vantobra is less than other tobramycin nebulizers and comparable to the time required to inhale dry powder. Vantobra therefore offers the advantage of better convenience and greater likelihood that patients will follow the treatment. As for safety, the committee noted that the safety profile of inhaled tobramycin is widely known. There are no unusual safety effects in relation to the use of Vantobra.
What measures are being taken to ensure the safe and effective use of Vantobra - tobramycin?
A risk management plan has been developed to ensure that Vantobra is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vantobra, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan
More information on Vantobra - tobramycin
On 18 March 2015, the European Commission issued a marketing authorization for Vantobra, valid throughout the European Union. For the full version of the EPAR and the summary of the Vantobra risk management plan, consult the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Vantobra therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 03-2015
