QUINSAIR Nebuliser solution Ref.[7177] Active ingredients: Levofloxacin

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 (creatinine clearance <20 ml/min).

Hepatic impairment

No dose adjustment is required (see section 5.2).

Paediatric population

The safety and efficacy of Quinsair in children aged ˂18 years old have not yet been established. Currently available data are described in sections 4.8, 5.1, 5.2 and 5.3 but no recommendation on a posology can be made.

Method of administration

Inhalation use.

Once an ampoule is opened, the contents should be used immediately (see section 6.6).

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.

Quinsair should only be used with the Zirela Nebuliser Handset (including a Zirela Aerosol Head) provided in the pack connected to an eBase Controller or an eFlow rapid Control Unit (see section 6.6). The Manufacturer’s Instructions for Use of the Zirela Nebuliser System should be reviewed prior to the first use of Quinsair.

In vitro studies using the Zirela Nebuliser System with Quinsair have demonstrated the following drug delivery characteristics: mass median aerodynamic diameter (droplet size distribution): 3.56 micrometres (1.51 geometric standard deviation); drug delivery rate: 24.86 mg/minute (4.05 standard deviation, SD) and total drug delivered: 236.1 mg (7.1 SD). The Zirela Nebuliser System was used to administer Quinsair in the clinical studies described in section 5.1.

In the event of overdose, symptomatic treatment should be implemented. The patient should be observed and appropriate hydration maintained. ECG monitoring should be undertaken because of the possibility of QT interval prolongation. Haemodialysis, including peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD), are not effective in removing levofloxacin from the body. No specific antidote exists.

Shelf life: 3 years.

Store in the original package in order to protect from light. This medicinal product does not require any special temperature storage conditions.

Ampoule: 3 ml, Low density polyethylene ampoule.

Sachet: Sealed foil laminate sachet containing 4 ampoules.

Inner box: 56 (14 sachets of 4) ampoules.

Outer box: Quinsair is supplied as a 28-day pack. This comprises an inner carton box containing 56 ampoules and a Package Leaflet. The outer carton box also contains one Zirela Nebuliser Handset packaged in its own carton box with the Manufacturer’s Instruction for Use.

For single use only. Once an ampoule is opened, the contents should be used immediately. Any unused product must be discarded.

Quinsair is administered by inhalation over a 5 minute period using a Quinsair specific Zirela Nebuliser Handset and Zirela Aerosol Head connected to an eBase Controller or an eFlow rapid Control Unit (see section 4.2). Quinsair should not be used with any other type of handset or aerosol head.

Basic instructions for use are given below. More detailed instructions are available in the Package Leaflet and device Manufacturer’s Instructions for Use.

Squeeze all of the contents of one ampoule into the medicine reservoir of the Zirela Nebuliser Handset. Close the medicine reservoir by aligning the tabs of the medicine cap with the slots of the reservoir. Press down and turn the cap clockwise as far as it will go. Sit the patient in a relaxed, upright position. Holding the handset level, press and hold the on/off button on the controller for a few seconds. The controller will ‘beep’ once and the status light will turn green. After a few seconds, an aerosol mist will begin to flow into the aerosol chamber of the Zirela Nebuliser Handset. Keeping the handset level, place the mouthpiece in the patient’s mouth making sure their lips are closed around it. Ask the patient to inhale and exhale through the mouthpiece until the treatment is finished. When the treatment is complete, the controller will ‘beep’ twice. Disconnect the controller and dismantle the Zirela Nebuliser Handset for cleaning and disinfection.

Do not put other medicinal products into the Zirela Nebuliser Handset.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.