Quinsair

2). The doses should be inhaled as close as possible to 12 hours apart. 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.

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.

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 . Quinsair is not recommended for use in patients with severe renal impairment.

2). Paediatric population The safety and efficacy of Quinsair in children aged ˂ 18 years old have not yet been established. 3 but no recommendation on a posology can be made. Method of administration Inhalation use. 6). For patients taking multiple inhaled therapies, the recommended order of administration is as follows: 1.

Bronchodilators; 2. Dornase alfa; 3. Airway clearance techniques; 4. Quinsair; 5. Inhaled steroids. 6). The Manufacturer’s Instructions for Use of the Zirela Nebuliser System should be reviewed prior to the first use of Quinsair.

Summary of the safety profile The most frequently reported adverse reactions were cough/productive cough (54%), dysgeusia (30%) and fatigue/asthenia (25%). Tabulated list of adverse reactions reported with Quinsair The adverse reactions with at least a reasonable possibility of a causal relationship with Quinsair are presented according to the MedDRA System Organ Classification.

The adverse drug reactions are ranked by frequency with the most frequent reactions first. The frequency categories are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data).

4). * Adverse events with uncertain relatedness to Quinsair but which are known to be associated with systemic administration of levofloxacin and/or are plausibly associated with Quinsair and were reported more frequently than with placebo in clinical studies.

4). *** See paragraph below for further details. Tabulated list of additional adverse reactions reported following systemic administration of levofloxacin The adverse reactions with at least a reasonable possibility of a causal relationship with levofloxacin are presented according to the MedDRA System Organ Classification.

The adverse drug reactions are ranked by frequency with the most serious reactions first. The frequency categories are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data).

g. hallucination, paranoia), Agitation, Abnormal dreams, Nightmares Psychotic disorders with self-endangering behaviour including suicidal ideation or suicide attempt Nervous system disorders1 Tremor Convulsion, Paraesthesia Peripheral sensory neuropathy, Peripheral sensory motor neuropathy, Dyskinesia, Extrapyramidal disorder, Syncope, Benign intracranial hypertension Eye disorders1 Transient vision loss Ear and labyrinth disorders1 Vertigo Cardiac disorders** Palpitation Ventricular tachycardia, Ventricular arrhythmia and torsade de pointes Vascular disorders** Hypotension Respiratory, thoracic and mediastinal disorders Pneumonitis allergic Hepatobiliary disorders Jaundice and severe liver injury, including cases with fatal acute liver failure Skin and subcutaneous tissue disorders Hyperhidrosis Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Fixed drug eruption Toxic epidermal necrolysis, Stevens-Johnson syndrome, Erythema multiforme, Photosensitivity reaction, Leukocytoclastic vasculitis, Stomatitis Musculoskeletal and connective tissue disorders1 Muscular […]

8). 3). g. including angioedema and anaphylactic shock). 8). g. 8). 4 Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop such as anorexia, jaundice, dark urine, pruritus or tender abdomen.

9) such as, for example: • Congenital long QT syndrome. g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics). g. hypokalaemia, hypomagnesaemia). g. heart failure, myocardial infarction, bradycardia).

Elderly patients and women may be more sensitive to QTc-prolonging medicinal products. Therefore, caution should be taken when using fluoroquinolones, including levofloxacin, in these populations. 8). 5). Psychotic reactions Psychotic reactions have been reported in patients receiving quinolones, including levofloxacin.

8). Caution is recommended if levofloxacin is used in psychotic patients or in patients with a history of psychiatric disease. Peripheral neuropathy Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones.

8). Exacerbation of myasthenia gravis Fluoroquinolones, including levofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Post-marketing serious adverse reactions, including deaths and the requirements for respiratory support, have been associated with fluoroquinolone use in patients with myasthenia gravis.

Levofloxacin is not recommended in patients with a known history of myasthenia gravis. Tendinitis and tendon rupture Tendinitis and tendon rupture (especially, but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment.

1; • History of tendon disorders related to fluoroquinolone administration; • Epilepsy; • Pregnancy; • Breast-feeding.