natgillin/translations-raw huggingface dataset:
The vial should be vigorously shaked until contents are completely dissolved.
Vialo je treba močno stresati, dokler se vsebina popolnoma ne raztopi.
Fluoroquinolones have been associated with an increased risk of central nervous system (CNS) reactions, including: convulsions and increased intracranial pressure (including pseudotumor cerebri) and toxic psychosis.
Fluorokinoloni so bili povezani s povečanim tveganjem za reakcije centralnega ţ ivčnega sistema (CNS - Central Nervous system), vključno s konvulzijami in zvišanim intrakranialnim tlakom (vključno s psevdotumor cerebri) in toksično psihozo.
• Feeling lightheaded or faint, usually because of a drop in blood pressure
• občutek vrtoglavosti ali izgube zavesti, največkrat zaradi padca krvnega tlaka
Dyspnoea Cough Dry throat
Dispneja Kašelj Suho grlo
If you might become pregnant you have to use effective contraception during treatment with Quofenix.
Če bi lahko zanosili, morate med zdravljenjem z zdravilom Quofenix uporabljati učinkovito kontracepcijo.
Accumulation of the intravenous vehicle sulfobutylbetadex sodiumoccurs in patients with moderate to severe renal impairment; therefore serum creatinine levels should be closely monitored in these patients, and, if increases occur, consideration should be given to switch to Quofenix 450 mg tablet every 12 hours.
Kopičenje intravenskega nosilca natrijevega sulfobutilbetaciklodekstrina se pojavi pri zmernih do hudih ledvičnih okvarah, zato je treba pri teh bolnikih skrbno spremljati ravni kreatinina v serumu, in če pride do zvišanja, je treba razmisliti o prehodu na zdravilo Quofenix 450 mg tablete vsakih 12 ur.
The effects of delafloxacin on fertility in humans have not been studied.
Učinkov delafloksacina na plodnost pri ljudeh niso raziskali.
• If you have ever had a problem with your tendons such as tendonitis that was related to treatment with a ‘quinolone antibiotic'.
• Če ste ţe kdaj imeli teţave s tetivami, na primer tendonitisom, ki je bil povezan z zdravljenjem s kinolonskim antibiotikom.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo
Pack sizes of 10 x1, 20 x1, 30 x1, 50 x1, 60 x1 or 100 x1 tablets.
Velikosti pakiranj po 10 x1, 20 x1, 30 x1, 50 x1, 60 x1 ali 100 x1 tablet.
Gastritis erosive
Erozivni gastritis
Patients with glucose-6-phosphate dehydrogenase deficiency
Bolniki s pomanjkanjem glukoza-6-fosfat dehidrogenaze
• an antacid, multivitamin, or other product that has magnesium, aluminium, iron, or zinc
• antacidov, multivinaminov ali drugih izdelkov, ki vsebujejo magnezij, aluminij, ţelezo ali cink
If you have diabetes, you should monitor your blood glucose levels carefully.
Če ste sladkorni bolnik, morate natančno spremljati svoje ravni glukoze v krvi.
• You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness especially in the feet and legs or hands and arms.
• Redko se pojavijo simptomi poškodbe ţivcev (nevropatija), kot so bolečina, ţarenje, mravljinčenje, otrplost in/ali šibkost, zlasti v stopalih in nogah, dlaneh in rokah.
You will be given one infusion of Quofenix, containing 300 mg of the medicine, twice a day between 5 and 14 days at the discretion of your doctor.
Prejeli boste eno infuzijo zdravila Quofenix, ki vsebuje 300 mg zdravila, dvakrat na dan med 5 in 14 dni, po presoji vašega zdravnika.
• didanosine buffered tablets for oral suspension or the paediatric powder for oral solution
• didanozinijevih puferskih tablet za peroralno suspenzijo ali pediatričnega praška za peroralno raztopino
See section 4.8 for how to report adverse reactions.
Glejte poglavje 4.8, kako poročati o neţ elenih učinkih.
Gram-positive micro-organisms:
Grampozitivni mikroorganizmi:
It is used to treat adults with serious short-term infections of the skin and tissues under the skin caused by certain bacteria when usual antibiotics cannot be used or have not worked.
Uporablja se za zdravljenje odraslih za kratkotrajno zdravljenje hudih okuţ b koţ e in tkiv pod koţ o, ki jih povzročajo nekatere bakterije, kadar običajnih antibiotikov ni mogoče uporabiti ali ne delujejo.
The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, and those treated concurrently with corticosteroids.
Tveganje za tendinitis in rupturo tetive je povečano pri starejših bolnikih, bolnikih z okvaro ledvic, bolnikih s presajenimi organi in pri tistih, ki se sočasno zdravijo s kortikosteroidi.
Pharmacotherapeutic group: Antibacterials for systemic use, fluoroquinolones, ATC code: J01MA23 Mechanism of action
Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje bakterijskih infekcij, fluorokinoloni, Oznaka ATC: J01MA23
Aortic dissection and aneurysm
Disekcija aorte in anevrizma
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, tell your doctor before you are given this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden boste prejeli to zdravilo.
The European Medicines Agency has waived the obligation to submit the results of studies with Quofenix in all subsets of the paediatric population in the treatment of local infections of skin and subcutaneous tissues (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odloţ ila zahtevo za predloţ itev rezultatov študij z zdravilom Quofenix za vse podskupine pediatrične populacije za zdravljenje lokalne okuţ be koţ e in koţ nih struktur (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
In diabetic patients, careful monitoring of blood glucose is recommended.
Pri sladkornih bolnikih se priporoča skrbno spremljanje vrednosti glukoze v krvi.
Treatment of these patients with delafloxacin should only be initiated in the absence of alternative treatment options and after careful benefit/risk assessment (see also section 4.3).
Zdravljenje teh bolnikov z delafloksacinom se sme uvesti le, če ni drugih moţ nosti zdravljenja in po natančni oceni koristi/tveganja (glejte tudi poglavje 4.3).
Dosing in patients with severe renal impairment (CrCl of <30 mL/min) should be decreased to 200 mg intravenously every 12 hours; alternatively patients should receive 450 mg delafloxacin orally every 12 hours (see section 4.4 and 5.2).
Odmerek pri bolnikih s hudo ledvično okvaro (CrCl < 30 ml/min) je treba zniţ ati na 200 mg intravensko vsakih 12 ur, alternativno lahko bolniki prejemajo 450 mg delafloksacina peroralno vsakih 12 ur (glejte poglavji 4.4 in 5.2).
Clostridioides difficile-associated disease
Bolezen povezana s Clostridioides difficile
Long-term carcinogenicity studies have not been conducted with delafloxacin.
Dolgoročnih študij karcinogenosti z delafloksacinom niso opravili.
Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping Quofenix therapy.
Vnetje in pretrganje tetiv se lahko pojavijo ţ e v prvih 48 urah zdravljenja, lahko pa tudi več mesecev po prenehanju zdravljenja z zdravilom Quofenix.
Please, inform your doctor or nurse immediately if you get any of these symptoms, as the medicine should be stopped and you may need urgent medical attention:
Če opazite katerega koli od teh simptomov, nemudoma obvestite zdravnika ali medicinsko sestro, saj je treba zdravljenje prekiniti in boste morda potrebovali nujno medicinsko pomoč:
Resistance to fluoroquinolones, including delafloxacin, can occur due to mutations in defined regions of the target bacterial enzymes topoisomerase IV and DNA gyrase referred to as Quinolone-Resistance Determining Regions (QRDRs), or through other resistance mechanisms such as efflux mechanisms.
Odpornost na fluorokinolone, vključno z delafloksacinom, se lahko pojavi zaradi mutacij v določenih regijah tarčnih bakterijskih encimov topoizomeraze IV in DNA-giraze, t.i. regije kinolonskih odpornostnih determinant (QRDRs - Quinolone-Resistance Determining Regions), ali prek drugih mehanizmov odpornosti kot so mehanizmi izlivnih črpalk.
Peak plasma delafloxacin concentrations are achieved at the end of the 1 hour intravenous infusion.
Najvišje plazemske koncentracije delafloksacina so doseţ ene ob koncu 1-urne intravenske infuzije.
Sinus tachycardia Palpitations Bradycardia
Sinusna tahikardija Palpitacije Bradikardija
In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.
Ob nenadni bolečini v trebuhu, hrbtu ali prsnem košu se bolnikom priporoča, da se nemudoma posvetujejo z zdravnikom na urgentnem oddelku.
Delafloxacin 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.
Zdravljenje z delafloksacinom je treba prenehati takoj ob prvih znakih ali simptomih kakršnih koli resnih neţ elenih učinkov, bolniku pa je treba svetovati, naj se posvetuje z zdravnikom, ki mu je zdravilo predpisal.
If superinfection occurs during therapy, appropriate measures should be taken.
Če pride med zdravljenjem do superinfekcije, je potrebno ustrezno ukrepati.
Patients under treatment with delafloxacin should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop in order to prevent the development of potentially irreversible condition (see section 4.8).
Bolnike, ki se zdravijo z delafloksacinom, je treba opozoriti, da pred nadaljevanjem zdravljenja obvestijo svojega zdravnika, če se pojavijo simptomi nevropatije, kot so bolečina, pekoč občutek, mravljinčenje, odrevenelost ali šibkost, da se prepreči razvoj potencialno nepovratnega stanja (glejte poglavje 4.8).
Quofenix will be given to you by a nurse or doctor via an infusion (drip) into a vein.
Zdravilo Quofenix vam bo dal zdravnik ali medicinska sestra v obliki infuzije (kapanja) v ţ ilo.
The fAUC24/MIC ratio, as for other quinolone antibiotics, resulted in the pharmacokinetic/ pharmacodynamic parameter most closely associated with the efficacy of delafloxacin.
Razmerje fAUC24/MIK je, tako kot pri drugih kinolonskih antibiotikih, privedlo do farmakokinetičnega/farmakodinamičnega parametra, ki je najbolj povezan z učinkovitostjo delafloksacina.
Therefore, no dosage adjustment is necessary.
Zato prilagajanje odmerkov ni potrebno.
The tablets are swallowed whole with a sufficient amount of water, and can be taken with or without food.
Tablete je potrebno pogoltniti cele z dovolj veliko količino tekočine, lahko se jih vzame s hrano ali brez hrane.
Tell your doctor if you suffer from kidney problems because your dose may need to be adjusted.
Obvestite svojega zdravnika, če imate teţ ave z ledvicami, ker je v teh primerih potrebno odmerke prilagoditi.
There are no data concerning an interaction of intravenous delafloxacin with multivitamins, other supplements or didanosine.
Podatkov o medsebojnem delovanju intravensko uporabljenega delafloksacina z multivitamini, drugimi dodatki ali didanozinom ni.
It is unknown whether delafloxacin/metabolites are excreted in human milk.
Ni znano ali se delafloksacin/presnovki izločajo v materino mleko.
• You or a member of your family is known to have a deficiency in glucose-6-phosphate dehydrogenase.
• sami ali katerikoli član vaše druţine trpi za pomanjkanjem glukoza-6-fosfat-dehidrogenaze.
As with all quinolones, disturbances in blood glucose, including both hypoglycaemia and hyperglycaemia have been reported (see section 4.8), usually in diabetic patients receiving concomitant treatment with an oral hypoglycaemic agent (e.g., glibenclamide) or with insulin.
Tako kot pri vseh kinolonih so poročali o motnjah vrednosti glukoze v krvi, vključno s hipoglikemijo in hiperglikemijo (glejte poglavje 4.8), običajno pri sladkornih bolnikih, ki so se sočasno zdravili s peroralnimi antidiabetiki (npr. glibenklamid) ali z insulinom.
By blocking these enzymes, Quofenix kills bacteria that cause the infection.
Z blokiranjem teh encimov, zdravilo Quofenix ubije bakterije, ki povzročajo okuţ bo.
Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment.
Tendinitis in ruptura tetive (zlasti, a ne izključno, Ahilove tetive), včasih obojestransko, se lahko pojavita ţ e v 48 urah po začetku zdravljenja s kinoloni in fluorokinoloni, o njiju pa so poročali tudi še več mesecev po prenehanju zdravljenja.
The steady state volume of distribution of delafloxacin is about 40 L which approximates total body water.
V stanju dinamičnega ravnovesja je volumen porazdelitve delafloksacina je pribliţ no 40 l, kar pribliţ no ustreza celotni količini vode v telesu.
Paediatric population Quofenix is contraindicated in children and adolescents (see section 4.3).
Pediatrična populacija Zdravilo Quofenix je kontraindicirano pri otrocih in mladostnikih (glejte poglavje 4.3).
Some adverse drug reactions (e.g. dizziness, headache, visual disorders) may impair the patient's ability to concentrate and react, and therefore may constitute a risk in situations where the patient operates an automobile or machinery or engages in other activities requiring mental alertness and coordination.
Nekateri neţ eleni učinki (npr. omotica, glavobol, motnje vida) lahko poslabšajo bolnikovo koncentracijo in sposobnost reagiranja, zato lahko predstavljajo tveganje v okoliščinah, ko bolnik upravlja z avtomobilom ali stroji ali se ukvarja z drugimi dejavnostmi, ki zahtevajo mentalno pozornost in usklajenost gibov.
• Increase in the amount of enzymes produced by your liver called transaminases -shown in blood tests
• povečanje vrednosti encimov, ki nastajajo v jetrih, imenovanih transaminaze, kar kaţejo krvne preiskave
At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with delafloxacin should be discontinued and alternative treatment should be considered.
Ob prvem znaku tendinitisa (npr. boleča oteklina, vnetje) je treba zdravljenje z delafloksacinom prenehati in razmisliti o drugačnem zdravljenju.
• Cold sweat
• hladen znoj
Millmount Healthcare Block-7, City North Business Campus, Stamullen, Co. Meath Ireland or
Millmount Healthcare Block-7, City North Business Campus, Stamullen, Co. Meath Irska ali
MillMount Healthcare Block-7, City North Business Campus, Stamullen, Co. Meath Ireland or
MillMount Healthcare Block-7, City North Business Campus, Stamullen, Co. Meath Irska ali
Organism
Organizem
A tendon is the cord that joins your muscle to your skeleton.
Tetiva (kita) je »vrvica«, ki pritrjuje mišice na vaše okostje.
Clinically significant gender-related differences in delafloxacin pharmacokinetics have not been observed in healthy subjects or in patients with ABSSSI.
Klinično pomembnih razlik, povezanih s spolom, pri farmakokinetiki delafloksacina niso zaznali niti pri zdravih osebah niti pri bolnikih z ABSSSI.
• Seasonal allergy
• sezonske alergije
Each tablet contains 39 mg of sodium.
Ena tableta vsebuje 39 mg natrija.
Hypersensitivity (see section 4.4) Seasonal allergy
Preobčutljivost (glejte poglavje 4.4) Sezonska alergija
Gram-negative micro-organisms:
Gramnegativni mikroorganizmi:
What Quofenix is and what it is used for
Kaj je zdravilo Quofenix in za kaj ga uporabljamo
Therefore, delafloxacin should be taken at least 2 hours before or 6 hours after these agents.
Delafloksacin je zato potrebno vzeti najmanj 2 uri pred oziroma 6 ur po zauţ itju zgoraj omenjenih učinkovin.
There are no available data concerning specific effects of other medicinal products on delafloxacin.
Ni razpoloţ ljivih podatkov o posebnih učinkih drugih zdravil na delafloksacin.
This medicinal product does not require any special storage conditions if kept unopened in the original container.
Za shranjevanje zdravila ni posebnih navodil, če ga shranjujete zaprtega v originalni ovojnini.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neţ elenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
Cross-resistance between delafloxacin and other fluoroquinolones may be observed, although some isolates resistant to other fluoroquinolone may retain susceptibility to delafloxacin.
Opaţ ena je lahko navzkriţ na odpornost med delafloksacinom in drugimi fluorokinoloni, čeprav lahko nekateri izolati, odporni na druge fluorokinolone, ohranijo občutljivost na delafloksacin.
• Irregular or rapid heart beats, feeling your heart beat (palpitation), decrease of heart beat
• nepravilno ali hitro utripanje srca, občutek bitja srca (palpitacije), počasno bitje srca
Serious side effects
Resni neţeleni učinki
- Drop in blood pressure; blurred vision; dizziness.
- padec krvnega tlaka; motnje vida; omotica.
Fluoroquinolone antibiotics, including Quofenix, may cause levels of glucose in the blood to rise too high or fall too low.
Fluorokinolonski antibiotiki, vključno z zdravilom Quofenix, lahko povzročijo previsoke ali prenizke ravni glukoze v krvi.
Arthritis reactive
Reaktivni artritis
This medicine contains 175 mg of sodium (main component of cooking salt) in each vial.
To zdravilo vsebuje 175 mg natrija (glavne sestavine kuhinjske soli) na vialo.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Za navodila o rekonstituciji in redčenju zdravila pred uporabo glejte poglavje 6.6.
• You have experienced a previous episode of aortic dissection (a tear in the aorta wall).
• ste ţe kdaj doţiveli epizodo aortne disekcije (raztrganina aortne stene);
Efficacy has been demonstrated in clinical studies against the following pathogens that were susceptible to delafloxacin in vitro.
V kliničnih študijah je bila dokazana učinkovitost za naslednje patogene, ki so bili in vitro občutljivi na delafloksacin.
• You have or may have problems with the central nervous system (e.g. severe cerebral arteriosclerosis, epilepsy) or have other risk factors that may put you at more risk of having seizures (fits).
• imate ali ste imeli teţave z osrednjim ţivčnim sistemom (npr. huda cerebralna arterioskleroza, epilepsija) ali imate druge dejavnike tveganja, zaradi katerih obstaja večja nevarnost napada krčev.
The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Imetnik dovoljenja za promet z zdravilom mora prvo PSUR za to zdravilo predloţ iti v 6 mesecih po pridobitvi dovoljenja za promet.
• You may have a severe skin reaction such as blistering or lesion.
• ste kdaj imeli hude koţne reakcije, kot so mehurji ali lezije.
Pharmacokinetic/pharmacodynamic relationship
Farmakokinetično/farmakodinamična povezava
• Decrease of special blood cells necessary for blood clotting
• zmanjšano število posebnih krvnih celic, potrebnih za strjevanje krvi
There are no significant circulating metabolites (mean=9.6%) in humans.
Pri ljudeh ni pomembnih presnovkov v obtoku (povprečna vrednost = 9,6%).
In the two major trials in ABSSSI the types of infections treated were confined to cellulitis/erysipelas, abscesses and wound infections only.
V dveh večjih preskušanjih z ABSSSI so bile vrste zdravljenih okuţ b, omejene samo na celulitis/šen, abscese in okuţ be ran.
This is equivalent to 8.8% of the recommended maximum daily dietary intake of sodium for an adult.
To je enako 8,8% priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
It is available in packs containing 10 vials.
Na voljo je pakiranje po 10 vial.
If Clostridioides difficile-associated disease is suspected or confirmed treatment with delafloxacin should be discontinued and appropriate supportive measures together with the specific antibacterial treatment of C. difficile should be considered.
Če obstaja sum na ali potrditev bolezni, povezane s Clostridioides difficile, je treba zdravljenje z delafloksacinom prekiniti in razmisliti o ustreznih podpornih ukrepih, skupaj s specifičnim protibakterijskim zdravljenjem C. difficile.
At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking Quofenix, contact your doctor and rest the painful area.
Ob prvem znaku bolečine ali vnetja tetiv (na primer v gleţ nju, zapestju, komolcu, rami ali kolenu) prenehajte jemati zdravilo Quofenix, posvetujte se z zdravnikom in pustite, da prizadeti ud miruje.
Delafloxacin inhibits bacterial topoisomerase IV and DNA gyrase (topoisomerase II), enzymes required for bacterial DNA replication, transcription, repair, and recombination.
Delafloksacin zavira bakterijsko topoizomerazo IV in DNA-girazo (topoizomeraza II), encime, potrebne za podvajanje bakterijske DNA, prepisovanje, popravljanje in rekombinacijo.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Pred začetkom jemanja uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Other medicines and Quofenix
Druga zdravila in zdravilo Quofenix
Quofenix must not be used if you are pregnant or breast-feeding.
Zdravila Quofenix se ne sme uporabljati med nosečnostjo ali dojenjem.
Pharmacokinetic parameters are not altered in obese patients (BMI ≥ 30 kg/m2).
Pri bolnikih s prekomerno telesno maso se farmakokinetični parametri ne spremenijo (BMI ≥ 30 kg/m
• If you are allergic to any other fluoroquinolone or quinolone antibacterial medicine.
• Če ste alergični na katero koli drugo fluorokinolonsko ali kinolonsko protibakterijsko zdravilo.
If you feel sudden, severe pain in your abdomen, chest or back, go immediately to an emergency room.
Če v trebuhu, prsih ali hrbtu začutite nenadno hudo bolečino, takoj obiščite urgentno ambulanto.
The safety and efficacy of the dose recommendation in patients with severe renal impairment has not been clinically evaluated and is based on pharmacokinetic modelling data.
Varnosti in učinkovitosti priporočenega odmerka pri bolnikih s hudo okvaro ledvic niso klinično ocenili in temelji na podatkih farmakokinetičnega modeliranja.
- Abdominal (belly) pain with possible severe diarrhoea; fever and nausea.
- abdominalna bolečina (bolečina v trebuhu) z moţ no hudo drisko; vročina in slabost.
Corticosteroids should not be used if signs of tendinopathy occur (see section 4.8).
Če se pojavijo znaki tendinopatije, se ne sme uporabiti kortikosteroidov (glejte poglavje 4.8).
Prolonged, disabling and potentially irreversible serious side effects
Dolgotrajni, onesposabljajoči in potencialno ireverzibilni resni neţ eleni učinki
Injection/infusion site reaction
Reakcije na mestu injiciranja/infundiranja
• Worsening of a wound
• poslabšanje stanja rane
The safety and efficacy of the dose adjustment guidance in patients with severe renal impairment has not been clinically evaluated and is based on pharmacokinetic modelling data.
Varnost in učinkovitost prilagajanja odmerka pri bolnikih s hudo okvaro ledvic ni bila klinično ocenjena in temelji na podatkih farmakokinetičnega modeliranja.
Musculoskeletal and connective tissue disorders*
Bolezni mišičnoskeletnega sistema in vezivnega tkiva*
The following adverse reactions have been identified in four comparative ABSSSI Phase 2 and 3 studies classified by preferred term and System Organ Class, and by frequency.
Naslednji neţ eleni učinki, ki so bili zaznani v štirih primerjalnih študijah ABSSSI faze 2 in 3, so navedeni po prednostnih izrazih in organskih sistemih in razvrščeni po pogostnosti.
As per fluoroquinolone class patients aged over 60 years are at increased risk for developing severe tendon disorders including tendon rupture (see sections 4.4 and
Pri zdravilih iz skupine fluorokinolonov za bolnike, starejše od 60 let, obstaja večje tveganje za razvoj hudih teţ av s tetivami, vključno z rupturo tetive (glejte poglavji 4.4 in 5.2).