FrancophonIA/ELRC3.0 huggingface dataset:
English: Very common: may affect more than 1 in 10 people - Cough - Abnormal sense of taste - Tiredness, weakness and lower tolerance to exercise - Loss of appetite and weight loss - Shortness of breath - Changes in the amount and thickness of mucus/phlegm - Coughing up blood - Decreased amount of air that can be breathed out in one second (decreased FEV1 test)
Slovenian: Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov - kašelj - nenormalen občutek za okušanje - utrujenost, šibkost in slabše prenašanje vadbe - izgubo apetita in zmanjšanje telesne mase - kratka sapa - spremembe količine in gostote mukusa/sluzi - izkašljevanje krvi - zmanjšana količina zraka, ki ga lahko izdihnete v eni sekundi (zmanjšan rezultat testa FEV1)
English: Weight decreased**, Forced expiratory volume decreased*
Slovenian: Preiskave zmanjšanje telesne mase**, zmanjšanje forsiranega ekspiratornega volumna*
English: Do not put other medicinal products into the Zirela Nebuliser Handset.
Slovenian: V nebulator Zirela ne dajajte drugih zdravil.
English: One nebuliser handset should be used for one 28-day treatment course.
Slovenian: Nebulatorja ne uporabljajte dlje kot za en 28-dnevni cikel zdravljenja.
English: • Congenital long QT syndrome.
Slovenian: • sindromu prirojenega podaljšanja intervala QT,
English: Non-clinical studies conducted with levofloxacin using the inhalation route revealed no special hazard for humans based on conventional studies of safety pharmacology (respiratory), single dose toxicity and repeated dose toxicity.
Slovenian: Predklinične študije z levofloksacinom, uporabljenim z inhalacijo, na osnovi običajnih študij farmakološke (respiratorne) varnosti, toksičnosti enkratnih odmerkov in toksičnosti pri ponavljajočih odmerkih ne kažejo posebnega tveganja za človeka.
English: Due to possible increases in coagulation tests (PT/INR) and/or bleeding in patients treated with levofloxacin in combination with a vitamin K antagonist (e.g. warfarin), coagulation tests should be monitored when these active substances are given concomitantly (see section 4.5).
Slovenian: Med zdravljenjem z levofloksacinom v kombinaciji z antagonistom vitamina K (npr. varfarinom) se lahko pojavijo zvišane vrednosti koagulacijskih testov (PČ/INR) in/ali krvavitve, zato je treba med sočasno uporabo teh zdravilnih učinkovin spremljati koagulacijske teste (glejte poglavje 4.5).
English: - Do not use Quinsair if you notice that the sealed foil sachet or ampoules have been tampered with.
Slovenian: - Zdravila Quinsair ne uporabljajte, če opazite spremembe na nepredušno zaprti vrečici iz folije ali ampulah.
English: 500 mg IV QD*
Slovenian: 500 mg i.v.
English: Levofloxacin is systemically absorbed following inhalation of Quinsair and eliminated similarly to levofloxacin following systemic administration.
Slovenian: Po inhaliranju zdravila Quinsair se levofloksacin sistemsko absorbira in izloči podobno kot sistemsko uporabljen levofloksacin.
English: Sealed foil laminate sachet containing 4 ampoules.
Slovenian: Nepredušno zaprta vrečica iz laminirane folije, ki vsebuje 4 ampule.
English: Inhale your medicine as follows: - 1 ampoule in the morning using the Zirela Nebuliser - 1 ampoule in the evening using the Zirela Nebuliser It is best to leave close to 12 hours between your doses.
Slovenian: Zdravilo inhalirajte, kot sledi: - 1 ampulo zjutraj s pomočjo nebulatorja Zirela.
English: - Do not try to inhale Quinsair using any other type of nebuliser handset.
Slovenian: - Zdravila Quinsair ne inhalirajte z nobeno drugo vrsto nebulatorja.
English: This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, depression, memory impairment, severe fatigue, and severe sleep disorders.
Slovenian: To vključuje bolečino v kitah, mišicah in sklepih zgornjih in spodnjih okončin, težave pri hoji, nenormalne občutke, kot so mravljinčenje, ščemenje, žgečkanje, odrevenelost ali skelenje (parestezija), motnje čutil, vključno z okvaro vida, okusa, vonja in sluha, depresijo, motnje spomina, hudo utrujenost in hude motnje spanja.
English: How to use it
Slovenian: Kako uporabljati zdravilo
English: ≥ 12 to < 18 years, n (%) ≥ 18 years, n (%) Baseline mean (SD) Relative change from Baseline to Day 28
Slovenian: ≥ 12 do < 18 let, n (%) ≥ 18 let, n (%)
English: LS mean [95% CI]: P = 0.046 e
Slovenian: Povprečje LS [95-% IZ]: P=0,046 e
English: When the treatment is complete, the controller will ‘beep' twice.
Slovenian: Po koncu zdravljenja krmilnik dvakrat zapiska.
English: Disconnect the controller and dismantle the Zirela Nebuliser Handset for cleaning and disinfection.
Slovenian: Krmilnik odklopite in nebulator Zirela razstavite, da ga očistite in razkužite.
English: Blood alkaline phosphatase increased*, Electrocardiogram QT prolonged*, Eosinophil count increased*, Platelet count decreased*
Slovenian: nenormalne vrednosti jetrne funkcije, povečanje ravni alkalne fosfataze v krvi* podaljšan interval QT na elektrokardiogramu*, povečano število eozinofilcev*, zmanjšano število trombocitov*
English: Tendinitis was reported in patients with CF receiving Quinsair as an uncommon adverse reaction during clinical trials (see section 4.8).
Slovenian: Med kliničnimi preskušanji so pri bolnikih s CF, ki so prejemali zdravilo Quinsair, poročali o tendinitisu kot o občasnem neželenem učinku (glejte poglavje 4.8).
English: Please refer to the Manufacturer's Instructions for Use for cleaning and storage advice.
Slovenian: Za nasvete o čiščenju in shranjevanju glejte navodila izdelovalca za uporabo.
English: 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.
Slovenian: Predklinični podatki na osnovi običajnih študij toksičnosti pri enkratnem odmerku, toksičnosti pri ponavljajočih odmerkih, kancerogenega potenciala in vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: If acute, symptomatic bronchospasm occurs after receiving treatment, patients may benefit from the use of a short-acting inhaled bronchodilator prior to subsequent doses (see section 4.2).
Slovenian: Če se po prejemu zdravila pojavi akuten, simptomatski bronhospazem, lahko bolnikom morda koristi uporaba kratkodelujočega inhaliranega bronhodilatatorja pred naslednjimi odmerki (glejte poglavje 4.2).
English: A total of 259 patients were randomised to Quinsair 240 mg twice daily for 28 days (≥ 18 years, n = 226; ≥ 12 to < 18 years old, n = 33) and 147 were randomised to placebo (≥ 18 years, n = 127; ≥ 12 to < 18 years old, n = 20).
Slovenian: Skupaj 259 bolnikov je bilo randomiziranih za prejemanje zdravila Quinsair 240 mg dvakrat na dan za obdobje 28 dni (≥ 18 let, n = 226; ≥ 12 do < 18 let, n = 33) in 147 bolnikov je bilo randomiziranih v skupino s placebom (≥ 18 let, n = 127; ≥ 12 do < 18 let, n = 20).
English: The effects of race on the pharmacokinetics of levofloxacin administered by inhalation have not been studied.
Slovenian: Učinka rase na farmakokinetiko levofloksacina, uporabljenega z inhaliranjem, niso preučili.
English: What Quinsair contains - The active substance is levofloxacin.
Slovenian: Kaj vsebuje zdravilo Quinsair - Zdravilna učinkovina je levofloksacin.
English: Psychiatric disorders1
Slovenian: Psihiatrične motnje1
English: (platelets) - Low or high numbers of white cells in the blood - Feeling anxious, restless or agitated and/or depressed - Reduced sense of smell - Feeling sleepy - Changes in eyesight - Loss of hearing - Increased heart beat - Difficulty in breathing - Retching - Indigestion - Passing wind - Hives/nettle rash and itching - Chest wall pain - Kidney failure - Changes in heart rhythm
Slovenian: (trombocitov) - majhno ali veliko število belih krvnih celic - občutek anksioznosti, nemira ali vznemirjenosti in/ali depresija - zmanjšan čut za voh - zaspanost - spremembe vida - izguba sluha - hitrejši srčni utrip - težave z dihanjem - spahovanje - prebavne težave - vetrovi - koprivnica/urtikarija in srbenje - bolečine v steni prstnega koša
English: Close the medicine reservoir by aligning the tabs of the medicine cap with the slots of the reservoir.
Slovenian: Zaprite vsebnik za zdravilo tako, da poravnate jeziček pokrova za zdravilo z zarezami na vsebniku.
English: Each ampoule contains 240 mg of levofloxacin.
Slovenian: Ena ampula vsebuje 240 mg levofloksacina.
English: Baseline to Day 28 of Cycle 1
Slovenian: Sprememba od izhodišča do 28. dneva 1. cikla
English: Cases of severe bullous skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with systemic administration of levofloxacin (see section 4.8).
Slovenian: Pri sistemski uporabi levofloksacina so poročali o hudih buloznih kožnih reakcijah, npr. Stevens-Johnsonovem sindromu ali toksični epidermalni nekrolizi (glejte poglavje 4.8).
English: If you notice any changes in your eyesight or any other problems with your eyes whilst using Quinsair, contact an eye specialist immediately.
Slovenian: Če se med uporabo zdravila Quinsair pojavijo motnje vida ali kakršni koli učinki na očeh, se morate takoj posvetovati s specialistom za oči.
English: LIST OF EXCIPIENTS magnesium chloride hexahydrate and water for injections.
Slovenian: SEZNAM POMOŽNIH SNOVI magnezijev klorid heksahidrat in voda za injekcije
English: Peripheral sensory neuropathy, Peripheral sensory motor neuropathy, Dyskinesia, Extrapyramidal disorder,
Slovenian: Bolezni živčevja1 tremor konvulzije, parestezija periferna senzorična nevropatija, periferna senzorimotorična nevropatija, diskinezija, ekstrapiramidna motnja, sinkopa, benigna intrakranialna hipertenzija
English: Hazard ratio [95% CI] d: P = 0.154 e
Slovenian: Razmerje tveganja [95-% IZ]d: P = 0,154 e
English: The effects of renal impairment on the pharmacokinetics of levofloxacin administered by inhalation have not been studied.
Slovenian: Učinka okvare ledvic na farmakokinetiko levofloksacina, uporabljenega z inhaliranjem, niso preučili.
English: In addition, the pharmacokinetics of weight-based doses of levofloxacin administered by inhalation once daily for 14 days in paediatric patients with CF (≥ 6 to < 12 years old, n = 14 and ≥ 12 to < 17 years old, n = 13) were evaluated in Study 206.
Slovenian: Poleg tega so v študiji 206 ocenili farmakokinetiko odmerkov levofloksacina na podlagi telesne mase, uporabljenih v obliki inhalacije enkrat na dan za 14 dni pri pediatričnih bolnikih s CF (≥ 6 do < 12 let, n = 14 in ≥ 12 do < 17 let, n = 13).
English: The pharmacokinetics of levofloxacin administered by inhalation have not been studied in the elderly.
Slovenian: Farmakokinetike levofloksacina, uporabljenega z inhaliranjem, niso preučili pri starejših bolnikih.
English: If acute, symptomatic bronchoconstriction occurs after receiving Quinsair, patients may benefit from the use of a short-acting inhaled bronchodilator prior to subsequent doses (see sections 4.2 and 4.4).
Slovenian: Če se po prejemu zdravila Quinsair pojavi akutna, simptomatska bronhokonstrikcija, lahko bolnikom morda koristi uporaba kratkodelujočega inhaliranega bronhodilatatorja pred naslednjimi odmerki (glejte poglavji 4.2 in 4.4).
English: Toxic epidermal necrolysis,
Slovenian: Bolezni kože in podkožja hiperhidroza toksična epidermalna nekroliza,
English: Each ml of nebuliser solution contains levofloxacin hemihydrate equivalent to 100 mg of levofloxacin.
Slovenian: En mililiter inhalacijske raztopine za nebulator vsebuje levofloksacin hemihidrat v količini, ki ustreza 100 mg levofloksacina.
English: Quinsair should not be used with any other type of handset or aerosol head.
Slovenian: Zdravila Quinsair ne uporabljajte z drugimi vrstami nebulatorjev ali pršilnih glav.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON BOX CONTAINING 56 (14 SACHETS OF 4) AMPOULES
Slovenian: PODATKI NA ZUNANJI OVOJNINI NOTRANJA ŠKATLA, KI VSEBUJE 56 AMPUL (14 VREČIC S PO 4 AMPULAMI)
English: FEV1 Relative change from Baseline to Day 28 of Cycle 3
Slovenian: Relativna sprememba FEV1 od izhodišča do 28. dneva 3. cikla
English: Levofloxacin is contraindicated in patients with a history of epilepsy (see section 4.3) and, as with other quinolones, should be used with extreme caution in patients predisposed to seizures or on concomitant treatment with active substances that lower the cerebral seizure threshold, such as theophylline (see section 4.5).
Slovenian: Tako kot druge kinolone ga je treba izredno previdno uporabljati pri bolnikih z nagnjenostjo h konvulzivnim napadom ali pri sočasnem zdravljenju z zdravilnimi učinkovinami, ki znižujejo prag za cerebralne napade, kot je teofilin (glejte poglavje 4.5).
English: Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones.
Slovenian: Pri bolnikih, ki so dobivali kinolone in fluorokinolone, so poročali o primerih senzorične ali senzorimotorične polinevropatije, ki se je odražala kot parestezija, hipestezija, disestezija ali šibkost.
English: Jaundice and severe liver injury, including cases with fatal acute liver failure
Slovenian: Bolezni jeter, žolčnika in žolčevodov zlatenica in hude poškodbe jeter, vključno s smrtnimi primeri akutne odpovedi jeter
English: Anaphylactic shock, Anaphylactoid shock
Slovenian: Bolezni imunskega sistema angioedem anafilaktični šok, anafilaktoidni šok
English: Hypotension
Slovenian: Hemoptiza
English: Try not to breathe through your nose.
Slovenian: Ne poskušajte dihati skozi nos. Sproščeno vdihujte in izdihujte do konca zdravljenja.
English: Holding the handset level, press and hold the on/off button on the controller for a few seconds.
Slovenian: Nebulator držite ravno ter pritisnite in nekaj sekund držite gumb za vklop/izklop na krmilniku.
English: Press down and turn the cap clockwise as far as it will go.
Slovenian: Pokrov za zdravilo pritisnite navzdol in ga obračajte v smeri urnega kazalca, dokler gre.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of nebuliser solution contains levofloxacin hemihydrate equivalent to 100 mg of levofloxacin.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN En mililiter inhalacijske raztopine za nebulator vsebuje levofloksacin hemihidrat v količini, ki ustreza 100 mg levofloksacina.
English: Levofloxacin is metabolised to a very small extent, the metabolites being desmethyl-levofloxacin and levofloxacin N-oxide.
Slovenian: Levofloksacin se presnavlja v zelo majhni meri v presnovka desmetil-levofloksacin in levofloksacin N-oksid.
English: • History of tendon disorders related to fluoroquinolone administration.
Slovenian: • bolezni tetiv, povezane z dajanjem fluorokinolonov, v anamnezi
English: Hepatitis*, Hyperbilirubinaemia*
Slovenian: Bolezni jeter, žolčnika in žolčevodov hepatitis*, hiperbilirubinemija*
English: LS Mean (SE) Treatment Difference at Day 28 [95% CI] b
Slovenian: 28. dan [95-% IZ] b
English: Talk to your doctor if you have any concerns or questions about this and using Quinsair.
Slovenian: Če imate v zvezi s tem in uporabo zdravila Quinsair kakršne koli pomisleke ali vprašanja, se posvetujte z zdravnikom.
English: Psychotic reactions (e.g. hallucination, paranoia), Agitation, Abnormal dreams, Nightmares
Slovenian: stanje zmedenosti, živčnost psihotične reakcije (npr. halucinacije, paranoja), agitacija, nenormalne sanje, nočne more psihotične motnje s samoogrožajočim vedenjem, vključno s samomorilnim razmišljanjem ali poskusi samomora
English: Hazard ratio [95% CI] d: P = 0.040 e
Slovenian: Razmerje tveganja [95-% IZ]d: P = 0,040 e
English: This is because both active substances are capable of blocking the renal tubular secretion of levofloxacin.
Slovenian: Oba namreč lahko zavreta sekrecijo levofloksacina v ledvičnih tubulih.
English: • Breast-feeding women.
Slovenian: • doječe ženske
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Magnesium chloride hexahydrate Water for injections
Slovenian: 6.1 Seznam pomožnih snovi magnezijev klorid heksahidrat
English: The controller will ‘beep' once and the status light will turn green. After a few seconds, an aerosol mist will begin to flow into the aerosol chamber of the Zirela Nebuliser Handset.
Slovenian: Po nekaj sekundah bo začel v komoro za aerosol nebulatorja Zirela pršeti aerosol.
English: Levofloxacin did not show any genotoxic potential in a photomutagenicity assay.
Slovenian: Z fotomutagenskim testom so pokazali, da levofloksacin nima genotoksičnega potenciala.
English: The Zirela Nebuliser System was used to administer Quinsair in the clinical studies described in section 5.1.
Slovenian: V kliničnih študijah, opisanih v poglavju 5.1, je bil za dajanje zdravila Quinsair uporabljen nebulatorski sistem Zirela.
English: Uncommon (≥ 1/1,000 to
Slovenian: Redki (≥ 1/10.000 do
English: If you experience palpitations or an irregular heart beat whilst using Quinsair you should tell your doctor immediately.
Slovenian: Če se med uporabo zdravila Quinsair pojavijo palpitacije ali nereden srčni utrip, se takoj posvetujte z zdravnikom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON BOX CONTAINING INNER CARTON BOX CONTAINING 56 (14 SACHETS OF 4) AMPOULES PLUS ONE “ZIRELA” NEBULISER HANDSET
Slovenian: ZUNANJA ŠKATLA Z NOTRANJO ŠKATLO, KI VSEBUJE 56 AMPUL (14 VREČIC S PO 4 AMPULAMI) IN EN NEBULATOR "ZIRELA"
English: You may develop diarrhoea during or after your treatment with Quinsair.
Slovenian: Med zdravljenjem z zdravilom Quinsair ali po njem se lahko pojavi driska.
English: - Do not mix Quinsair with any other medicines in the Zirela Nebuliser Handset.
Slovenian: - Zdravila Quinsair v nebulatorju Zirela ne mešajte z drugimi zdravili.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING FOIL LAMINATE SACHET CONTAINING 4 AMPOULES
Slovenian: PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI VREČICE IZ LAMINIRANE FOLIJE, KI VSEBUJEJO 4 AMPULE
English: 5) Breathe normally (inhale and exhale) through the mouthpiece.
Slovenian: Slika 3 5) Normalno dihajte (vdihavajte in izdihavajte) skozi ustnik.
English: Common: may affect up to 1 in 10 people - Fungal infection around vagina - Insomnia or difficulty sleeping - Headache - Dizziness - Ringing or noise in the ears (tinnitus) - Change to the voice - Feeling and being sick - Abdominal pain - Diarrhoea - Constipation - Rash - Joint or muscle pain - Fever - Abnormal blood test results (increased levels of certain liver enzymes or bilirubin in the blood,
Slovenian: Pogosti: pojavijo se lahko pri do 1 od 10 bolnikov - glivične okužbe okoli nožnice - nespečnost ali težave s spanjem - glavobol - omotica - zvenenje ali šum v ušesih (tinitus) - spremembe glasu - občutek slabosti in bruhanje - bolečine v trebuhu - driska - zaprtje - izpuščaj - bolečina v sklepih ali mišicah - zvišana telesna temperatura - nenormalni rezultati krvnih testov (zvišane ravni nekaterih jetrnih encimov ali bilirubina v krvi in zmanjšan rezultat testa delovanja ledvic) - zmanjšan rezultat testa pljučne funkcije - povečana ali zmanjšana količina sladkorja (glukoze) v krvi - nenormalni zvoki pri dihanju
English: Quinsair 240 mg nebuliser solution Levofloxacin
Slovenian: Quinsair 240 mg inhalacijska raztopina za nebulator levofloksacin
English: NAME OF THE MEDICINAL PRODUCT Quinsair 240 mg nebuliser solution
Slovenian: IME ZDRAVILA Quinsair 240 mg inhalacijska raztopina za nebulator
English: Erythema multiforme, Photosensitivity reaction,
Slovenian: Stevens-Johnsonov sindrom, multiformni eritem, fotosenzitivne reakcije, levkocitoklastični vaskulitis, stomatitis
English: High levofloxacin concentrations were observed in sputum following Quinsair 240 mg twice daily dosing in patients with CF.
Slovenian: Po odmerjanju zdravila Quinsair 240 mg dvakrat na dan pri bolnikih s CF so v sputumu opazili visoke koncentracije levofloksacina.
English: - Do not put any medicines other than Quinsair in the Zirela Nebuliser Handset.
Slovenian: - V nebulator Zirela ne dajajte drugih zdravil, razen zdravila Quinsair.
English: - Kidney problems.
Slovenian: - Težave z ledvicami.
English: FEV1 Relative change from Baseline to Day 28 of Cycle 2
Slovenian: Sekundarni opazovani dogodki: Relativna sprememba FEV1 od izhodišča do 28. dneva 2. cikla
English: The adverse reactions with at least a reasonable possibility of a causal relationship with Quinsair are presented according to the MedDRA System Organ Classification.
Slovenian: Neželeni učinki z vsaj razumno možnostjo vzročne zveze z zdravilom Quinsair so predstavljeni po razvrstitvi na organske sisteme v skladu z MedDRA. Neželeni učinki zdravila so razvrščeni po pogostnosti, pri čemer so najpogostejši neželeni učinki našteti prvi.
English: Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and/or aortic dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet's disease, hypertension, known atherosclerosis).
Slovenian: Pri bolnikih s pozitivno družinsko anamnezo anevrizme ali pri bolnikih, ki so jim postavili diagnozo obstoječe aortne anevrizme in/ali aortne disekcije, ali ob prisotnosti drugih dejavnikov tveganja ali stanj, ki imajo predispozicijo za aortno anevrizmo in disekcijo (npr. Marfanov sindrom, vaskularna oblika Ehlers-Danlosovega sindroma, Takayasujev arteritis, velikocelični arteritis, Behçetova bolezen, hipertenzija, znana ateroskleroza), se smejo zato fluorokinoloni uporabljati le po natančni oceni razmerja med koristmi in tveganji ter razmisleku o drugih možnostih zdravljenja.
English: 1 Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting several, sometimes multiple, system organ classes and senses (including reactions such as tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impairment of hearing, vision, taste and smell) have been reported in association with the use of quinolones and fluoroquinolones in some cases irrespective of pre-existing risk factors (see section 4.4).
Slovenian: 1 V zelo redkih primerih so v povezavi z uporabo kinolonov ali fluorokinolonov, v nekaterih primerih ne glede na obstoječe dejavnike tveganja, poročali o dolgotrajnih (trajanje več mesecev ali let), onesposabljajočih in potencialno ireverzibilnih neželenih učinkih zdravila, ki so vplivali na različne organske sisteme in čute, včasih na več njih (vključno z učinki, kot so tendonitis, pretrganje tetive, artralgija, bolečina v okončinah, težave pri hoji, nevropatije, povezane s parestezijo, depresija, utrujenost, motnje spomina, motnje spanja ter okvara sluha, vida, okusa in vonja) (glejte poglavje 4.4).
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora alergijski pnevmonitis
English: Tabulated list of adverse reactions reported with Quinsair
Slovenian: Neželeni učinki, o katerih so poročali z zdravilom Quinsair, v obliki preglednice
English: Stomatitis
Slovenian: Disglikemija
English: - Diabetes
Slovenian: - Sladkorna bolezen
English: Increased coagulation tests (PT/INR) and/or bleeding, which may be severe, have been reported in patients treated with levofloxacin in combination with a vitamin K antagonist (e.g. warfarin).
Slovenian: Pri bolnikih, ki so dobivali levofloksacin v kombinaciji z antagonistom vitamina K (npr. varfarinom), so poročali o zvišanih vrednostih koagulacijskih testov (PČ/INR) in/ali krvavitvah, ki so lahko bile hude.