Maa: Armenia
Kieli: englanti
Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
moxifloxacin (moxifloxacin hydrochloride)
Bayer Pharma AG
J01MA14
moxifloxacin (moxifloxacin hydrochloride)
1.6mg/ml
solution for infusion
glass vial 250ml
Prescription
Registered
2015-10-20
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Lue koko asiakirja
, 1 r section 5.2 far more details). There is insufficient data in patients with impaired liver firnction (see seotion '4r3)r Other special populations i.{$ No adjustment of dosage is required in the elderly and in patients with low l l r Paediatric population Moxifloxacin is contraindicated in chitdren and growing adolescents. Efficacy and safety of moxifloxacin in chilclren and adolescents have not been establishecl (see section 4.3). Method of adrn in istration For inffavenous use; constant inf,usion over 60 minutes (sce also scction 4.4). ' : : : l . lf medically indicated the solution for infusion can be administered via a T-tube, together with compatible infusion solutions (see section 6.6). 4.3 C o n t r a i n d i c a t i o n s ' 6 . 1 . ' Hypersensitivity to moxifloxacin, other quinolones or to any of the excipients listed in section Pregnancy and lactation (see section 4,6). Patients below l8 years of age. Patients with a history of tendon disease/disorder related to quinolone treatment. Both in preclinical investigations and in huntans, changes in cardiac electrophysiology have been observed following exposure to moxifloxacin, in the form of QT prolongation. For reasons of drug safety, rnoxifloxacin is therefore contraindicated in patients with: - Congenital or documented acquired QT prolongation - Electrolyte disturbances,padicularly in uncorrected hypokalaenria - Clinicallyrelevarrtbradycardia - Clinically relevant heart failure with reduced left-ventricular ejection fraction - Previous history of symptomatic arrlrythmias Moxifloxacin should not bg used concurently lvith other drugs that prolong the QT interval (see also section 4.5), Due to lirnited clinical data, moxifloxacin is also contraindicated in patients with impairecl liver function (Child Pugh C) and in patients with transaminases increase > 5fold ULN. 4.4 Special warnings and precautions for use The beriefit of moxifloxacin treatment especially in infections with a low degree of severity should be balanced with the information conlained in Lue koko asiakirja