LEVOFLOXACIN IBIGEN

Posology The dosage depends on the type and severity of the infection and the susceptibility of the presumed causative pathogen. Treatment with Levofloxacin Ibigen after initial use of the intravenous preparation may be completed with an appropriate oral presentation according to the SPC of an appropriate oral presentation and as considered appropriate for the individual patient.

. Given the bioequivalence of the parenteral and oral forms, the same dosage can be used.

The following dose recommendations can be given for Levofloxacin Ibigen:

Dose in patients with normal renal function (creatinine clearance> 50 ml/min) Indication Daily dose regimen (according to severity) Duration of treatment1 (according to severity) Community-acquired pneumonia 500 mg once or twice daily 7-14 days Pyelonephritis 500 mg once daily 7-10 days Complicated urinary tract infections 500 mg once daily 7-14 days Chronic bacterial prostatitis 500mg once daily 28 days Complicated skin and soft tissue infections 500 mg once or twice daily 7-14 days Inhalation anthrax 500 mg once daily 8 weeks 1Treatment duration includes intravenous plus oral treatment.

The time to switch from intravenous to oral treatment depends on the clinical situation but is normally 2 to 4 days Special populations Impaired renal function (creatinine clearance 50ml/min) Dose regimen 250 mg/24 h 500 mg/24 h 500 mg/12 h Creatinine clearance first dose: 250 mg first dose: 500 mg first dose: 500 mg 50 - 20 ml/min then: 125 mg/24 h then: 250 mg/24 h then : 250 mg/12 h 19-10 ml/min then: 125 mg/48 h then: 125 mg/24 h then: 125 mg/12 h < 10 ml/min (including haemodialysis and CAPD) 1 then: 125 mg/48 h then: 125 mg/24 h then: 125 mg/24 h 1No additional doses are required after haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

Impaired liver function No adjustment of dosage is required since levofloxacin is not metabolised to any relevant extent by the liver and is mainly excreted by the kidneys. 4 “Tendinitis and tendon rupture” and “QT interval prolongation”).

3). Method of administration Levofloxacin Ibigen solution for infusion is administered by slow intravenous infusion once or twice daily. 4). 6

The information given below is based on data from clinical studies in more than 8300 patients and on extensive post marketing experience. Frequencies are defined as follows: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).

In the following table, adverse reactions are listed by system organ class and MedDRA- preferred term. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. g. 4). 4), Parosmia including anosmia, Dyskinesia, Extrapyramidal disorder, Ageusia, Syncope, Benign intracranial hypertension.

g. g. due to interstitial nephritis) Common Infusion site reaction (pain, reddening) Uncommon Asthenia Rare Pyrexia General disorders and administration site conditions* Not known Pain (including pain in back, chest, and extremities) Endocrine disorders Rare Syndrome of inappropriate secretion of antidiuretic hormone (SIADH) aAnaphylactic and anaphylactoid reactions may sometimes occur even after the first dose.

4). A range of psychiatric symptoms may occur as part of these side effects, which may include, but are not necessarily limited to, sleep disorders, anxiety, panic attacks, confusion, or depression. There are no pharmacological treatments established to be effective treatments of the symptoms of long lasting or disabling side effects associated with fluoroquinolones.

The frequency of these prolonged, disabling and potentially irreversible serious drug […]

Prolonged, disabling and potentially irreversible serious adverse drug reactions Cases of prolonged (continuing for months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple, body systems (including musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk factors.

There are no pharmacological treatments established to be effective treatments of the symptoms of long lasting or disabling side effects associated with fluoroquinolones. Levofloxacin should be discontinued immediately at the first signs or symptoms of any serious adverse reaction and patients should be advised to contact their prescriber for advice, so that symptoms can be appropriately investigated and to avoid further exposure which could potentially worsen adverse reactions.

8). 3). Methicillin-resistant S. aureus are very likely to possess co-resistance to fluoroquinolones, including levofloxacin. Therefore levofloxacin is not recommended for the treatment of known or suspected MRSA infections unless laboratory results have confirmed susceptibility of the organism to levofloxacin (and commonly recommended antibacterial agents for the treatment of MRSA-infections are considered inappropriate).

Resistance to fluoroquinolones of E. coli – the most common pathogen involved in urinary tract infections – varies across the European Union. Prescribers are advised to take into account the local prevalence of resistance in E. coli to fluoroquinolones.

Inhalation Anthrax: use in humans is based on in vitro Bacillus anthracis susceptibility data and on animal experimental data together with limited human data. Treating physicians should refer to national and/or international consensus documents regarding the treatment of anthrax.

Aortic aneurysm and dissection, and heart valve regurgitation/incompetence Epidemiologic studies report an increased risk of aortic aneurysm and dissection, particularly in elderly patients, and of aortic and mitral valve regurgitation after intake of fluoroquinolones.

1 • in patients with epilepsy • in patients with history of tendon disorders related to fluoroquinolone administration • in children or growing adolescents • during pregnancy • in breast-feeding women