Quinsair 240 mg nebuliser solution
Each ml of nebuliser solution contains levofloxacin hemihydrate equivalent to 100 mg of levofloxacin. Each ampoule contains 240 mg of levofloxacin.
For the full list of excipients, see section 6.1.
Nebuliser solution.
Clear, pale yellow solution.
Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis (CF, see section 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Posology
The recommended dosage is 240 mg (one ampoule) administered by inhalation twice daily (see section 5.2).
Quinsair is taken in alternating cycles of 28 days on treatment followed by 28 days off treatment. Cyclical therapy may be continued for as long as the physician considers that the patient is obtaining clinical benefit.
The doses should be inhaled as close as possible to 12 hours apart.
If a dose is missed, it should be taken as soon as the patient remembers providing that at least an 8 hour interval is allowed before inhaling the next dose. Patients should not inhale the contents of more than one ampoule to compensate for the missed dose.
If acute symptomatic bronchospasm occurs after receiving Quinsair, patients may benefit from the use of a short-acting inhaled bronchodilator at least 15 minutes to 4 hours prior to subsequent doses (see sections 4.4 and 4.8).
Elderly patients (≥ 65 years old)
The safety and efficacy of Quinsair in elderly patients with CF have not been established.
Renal impairment
Doses do not need to be adjusted in patients with mild to moderate renal impairment (estimated creatinine clearance ≥ 20 ml/min using the Cockcroft-Gault formula). Quinsair is not recommended for use in patients with severe renal impairment
