QUINSAIR Nebuliser solution (2019)
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Περιεχόμενα
Name of the medicinal product
Quinsair 240 mg nebuliser solution.
Qualitative and quantitative composition
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.
Pharmaceutical form
Nebuliser solution. Clear, pale yellow solution.
Therapeutic indications
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 ...
Posology and method of administration
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 ...
Contraindications
Hypersensitivity to the active substance, other quinolones or to any of the excipients listed in section 6.1. History of tendon disorders related to fluoroquinolone administration. Epilepsy. Pregnancy. ...
Special warnings and precautions for use
The use of levofloxacin should be avoided in patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products (see section 4.8). Treatment ...
Interaction with other medicinal products and other forms of interaction
Effect of other medicinal products on levofloxacin Levofloxacin is primarily excreted unchanged in the urine and metabolism is minimal (see section 5.2). Interactions with CYP inhibitors or inducers are ...
Fertility, pregnancy and lactation
Pregnancy There is a limited amount of data from the use of levofloxacin in pregnant women. Animal studies with levofloxacin do not indicate direct or indirect harmful effects with respect to reproductive ...
Effects on ability to drive and use machines
Some adverse reactions (e.g. fatigue, asthenia, visual disturbances, dizziness) may impair patients ability to concentrate and react. Patients who experience such symptoms should be advised not to drive ...
Undesirable effects
Summary of the safety profile The safety of the recommended dose of Quinsair was evaluated in 472 patients with CF from two double-blind, single-cycle, placebo-controlled trials and from an active-comparator ...
Overdose
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 ...
Pharmacodynamic properties
Pharmacotherapeutic group: antibacterials for systemic use, fluoroquinolones ATC code: J01MA12 Levofloxacin is an antibacterial agent of the fluoroquinolone class and is the S (-) enantiomer of the racemic ...
Pharmacokinetic properties
Absorption The maximal plasma concentration (C<sub>max</sub>) of levofloxacin following administration by inhalation occurred at approximately 0.5-1 hour post-dose. Multiple dose administration of Quinsair ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of single dose toxicity, repeated dose toxicity, carcinogenic potential and toxicity to reproduction and development. ...
List of excipients
Magnesium chloride hexahydrate Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Store in the original package in order to protect from light. This medicinal product does not require any special temperature storage conditions.
Nature and contents of container
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 ...
Special precautions for disposal and other handling
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 ...
Marketing authorization holder
Chiesi Farmaceutici S.p.A., Via Palermo, 26/A, 43122 Parma, Italy
Marketing authorization number(s)
EU/1/14/973/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 26/03/2015
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