Land: Canada
Sprog: engelsk
Kilde: Health Canada
LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE)
PRO DOC LIMITEE
J01MA12
LEVOFLOXACIN
500MG
TABLET
LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE) 500MG
ORAL
50/100
Prescription
QUINOLONES
Active ingredient group (AIG) number: 0131663004; AHFS:
APPROVED
2016-10-03
pseudomonal β (≥65 yearsofage): § § § § § ≤ (≥65 yearsofage) therapy) occurringin ≥1%of ≥ ≤ ≥20 mL/min otherclasses ofantimicrobial agents,suchasβ maybe susceptibletofluoroquinolones.Forexample,β ∞ reported,unless otherwise specified; ≤ · · 65% predicted,with ≥4 exacerbationsinthepreceding 12monthsand/orthepresence ofsignificantco once daily for≥24hours 8hfor ≥3days ThemITTpopulationincluded patientswhohad aclinicaldiagnosisofAPorcUTIandwho had apositive(≥10 (≥ 10 ≥600mg/kg, ≥200mg/kg, ≥6mg/kg, ≥30mg/kg, ≥6mg/kg, respirationdepth;≤10 mg/kg, pressure;≥ ≥200mg/kg, ≥200mg/kg, ≥10x10 withimpairedrenal function(creatinineclearance≤80 mL/min). Dosageadjustmentmaybe ≤0.008 ≤0.008 ≤0.008 ≤ 0.008 ≤0.008 (MIC ≤0.06 ≤0.004 ≥2.0 ≤0.004 (MIC≤0.25 (MIC ≥1.0 (MIC ≥1.0 ≤2 ≥8 ≤2 ≤2 ≥8 ≥17 ≤13 ≥17 ≥17 ≤13 ↓ ↓ ↓ ↓ ↑ ↑ ↓ ↓ ↓ ↓ ↑ ↓ ↓ ↓ ♀ ♂ andhypothermiaat800mg/kg. Transient↓fcintreated ♂ ↓bw gainduring week 1in ♂ ↑ WBCdue to↑in lymphocytesat800mg/kg.PMNs↓ in ♀ ♂ ↓K ,andureaand ↑ P and ALT (primaril ↓relativeheartweightsat800 mg/kgand ↑ cecal ♀ ♂ Salivation,↑ largefecal haircoatmainlyat 320mg/kg. ↑ fc at80 and320mg/kg, ↑ ♀ ↓ PMNsin alltreated rats, ↑ glucose(treated ♂ ), ↓triglycerides (320 mg/kg♀ ↓ß (treatedrats),↓α ♀),↓Cl ♀ ↓total protein( ♂), and↑ urinarypHat 80and 320mg/kg. related ↑cecal weight, elongatedand/ordistendedceca and ♀ ♂ ↓bw at400and800mg/kg. ↓ (≥200 ♂ only).↑ALPat800mg/kg(♀ ↓absoluteliverweight≥400 ♂ ↑ cecalweightandcecal distension(≥100).Noarthropathy. ♂ ♂ ↑cecalweightand ↓ (mild)ASTand ALT at 160 mg/kg. Noarthropathy. ♀ ♂ Transient↓ ♂), ↓ ↓ activity, urinary protein,andRBC. ↑ WBC,retic, andfibrinogenat ↓ braindue to↓ ↑cecalweightat60 and 180mg/kg. Arthropathy at60 ♀ ♂ Slight↓fc ♂ Mild ↓ ♂ ↓ fc. Mild↑ A/Gandalbumin at30and 90 mg/kg(♂ ♂ ♀ ↑ Læs hele dokumentet