FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor or a pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Each ampoule is for single use only.
Slovenian: Vsaka ampula je samo za enkratno uporabo.
English: Study 207 (ITT)
Slovenian: Študija 207 (ITT)
English: How much do I use?
Slovenian: Koliko zdravila naj uporabim?
English: FEV1 percent predicted
Slovenian: Napovedani odstotek FEV1
English: Sometimes lengthy treatment with antibiotics can mean that you get another infection caused by other bacteria which are not affected by the antibiotic (superinfection).
Slovenian: Dolgotrajno zdravljenje z antibiotiki lahko včasih pomeni, da boste dobili še drugo okužbo, ki jo povzroča druga bakterija, na katero antibiotik ne vpliva (superinfekcija).
English: Pivotal Study - Study 209 (Core Phase; ITT)
Slovenian: Osrednja študija - študija 209 (osrednja faza; ITT)
English: Cyclical therapy may be continued for as long as the physician considers that the patient is obtaining clinical benefit.
Slovenian: S cikličnim zdravljenjem se lahko nadaljuje tako dolgo, dokler zdravnik ocenjuje, da ima bolnik klinične koristi.
English: * See paragraph below for further details.
Slovenian: * Za več podrobnosti glejte spodnji odstavek.
English: ** See paragraph below for further details.
Slovenian: ** Za več podrobnosti glejte spodnji odstavek.
English: - False test results
Slovenian: - Napačni rezultati preiskav
English: The frequency categories are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data).
Slovenian: Kategorije pogostnosti so opredeljene v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Elderly patients and women may be more sensitive to QTc-prolonging medicinal products.
Slovenian: Starejši bolniki in ženske so morda bolj občutljivi na zdravila, ki podaljšajo interval QTc.
English: 1) Make sure that the Zirela Nebuliser Handset is on a flat and stable surface.
Slovenian: 1) Prepričajte se, da je nebulator Zirela postavljen na ravno in stabilno površino.
English: What if I need to stop my treatment before I've finished?
Slovenian: Kaj naredim, če moram predčasno ustaviti zdravljenje?
English: Prevention of photosensitisation
Slovenian: Preprečitev fotosensibilizacije
English: You then start another treatment course.
Slovenian: Nato začnite naslednji cikel zdravljenja.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Slovenian: Pri zdravljenju je treba upoštevati uradne smernice o ustrezni uporabi protibakterijskih zdravil.
English: Quinsair should not be given to children and adolescents less than 18 years old as there is not enough information about its use in this age group.
Slovenian: Otroci in mladostniki, stari manj kot 18 let, zdravila Quinsair ne smejo uporabljati, saj ni dovolj podatkov o uporabi v tej starostni skupini.
English: 1) When you start your treatment, sit in a relaxed, upright position.
Slovenian: 1) Ob začetku zdravljenja sedite v sproščenem, vzravnanem položaju.
English: Interference with laboratory tests
Slovenian: Vpliv na laboratorijske preiskave
English: In the event of overdose, symptomatic treatment should be implemented.
Slovenian: V primeru prevelikega odmerjanja je treba uvesti simptomatsko zdravljenje.
English: Study 204 (ITT) a
Slovenian: Študija 204 (ITT) a
English: Women who take these types of medicines may be more likely to be affected.
Slovenian: Bolj pogosto so prizadete ženske, ki jemljejo te vrste zdravil.
English: Inhale this medicine at least 15 minutes or up to 4 hours before your next dose of Quinsair.
Slovenian: To zdravilo inhalirajte vsaj 15 minut ali do 4 ure pred naslednjim odmerkom zdravila Quinsair.
English: Interactions with CYP inhibitors or inducers are thus not expected.
Slovenian: Medsebojnega delovanja z zaviralci ali induktorji CYP zato ni pričakovati.
English: In addition to study drug, patients remained on standard of care treatment for chronic pulmonary infection.
Slovenian: Poleg študijskega zdravila so bolniki še naprej prejemali standardno oskrbo za kronično okužbo pljuč.
English: Parameter
Slovenian: Parametri
English: If you are diabetic, you should monitor your blood glucose levels carefully.
Slovenian: Če ste sladkorni bolnik, morate natančno spremljati svoje ravni glukoze v krvi.
English: Pain (including pain in back, chest and extremities)
Slovenian: bolečine (vključno z bolečinami v hrbtu, prsnem košu in udih)
English: If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately (see sections 4.7 and 4.8).
Slovenian: Če se pojavijo motnje vida ali se pojavijo kakršni koli učinki na očeh, se je treba nemudoma posvetovati s specialistom za oči (glejte poglavji 4.7 in 4.8).
English: 4) Keeping the handset level, place the mouthpiece in your mouth and close your lips around it (Figure 3).
Slovenian: 4) Nebulator držite ravno, dajte ustnik v usta in okoli njega zaprite ustnice (slika 3).
English: However, at the tested doses in the study, the statistically significant kinetic differences are unlikely to be of clinical relevance.
Slovenian: Toda pri odmerkih, testiranih v študiji, je malo verjetno, da bi bile statistično značilne razlike v kinetiki tudi klinično pomembne.
English: You will hear one ‘beep' and the status light will turn green.
Slovenian: Zaslišali boste pisk in statusna lučka se bo spremenila na zeleno.
English: Treatment Difference a
Slovenian: Razlika v zdravljenju na
English: These effects can be attributed to inhibition of topoisomerase II.
Slovenian: Te učinke je mogoče pripisati zaviranju topoizomeraze II.
English: Your risk is increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems or if you are being treated with corticosteroids.
Slovenian: Tveganje se poveča, če ste starejši (nad 60 let), so vam presadili organ, imate težave z delovanjem ledvic ali se zdravite s kortikosteroidi.
English: Following systemic administration, the effect of race on levofloxacin pharmacokinetics was examined through a covariate analysis performed on data from 72 subjects: 48 white and 24 non-white.
Slovenian: Po sistemski uporabi so učinek rase na farmakokinetiko levofloksacina preučili s pomočjo analize sospremenljivk s podatki za 72 oseb: 48 belcev in 24 ne-belcev.
English: Levofloxacin may inhibit the growth of Mycobacterium tuberculosis and, therefore, may give false-negative results in the bacteriological diagnosis of tuberculosis.
Slovenian: Levofloksacin lahko zavira rast Mycobacterium tuberculosis in s tem povzroči lažno negativne rezultate pri bakteriološki diagnozi tuberkuloze.
English: Prolonged, disabling and potentially irreversible serious adverse drug reactions
Slovenian: Dolgotrajni, onesposabljajoči in potencialno ireverzibilni neželeni učinki
English: Based on these limited data, there does not appear to be any clinically relevant difference in the safety profile of Quinsair in these subsets of the paediatric population compared to adults.
Slovenian: Na podlagi teh omejenih podatkov ne kaže, da bi obstajale kliničino pomembne razlike v profilu varnosti zdravila Quinsair v teh podskupinah pediatrične populacije v primerjavi z odraslimi.
English: The parameters associated with the antibacterial effects of levofloxacin are the Cmax/MIC and AUC/MIC ratios (Cmax = maximum concentration at the site of infection, AUC = area under the curve and MIC = minimal inhibitory concentration).
Slovenian: Parametra, povezana s protibakterijskimi učinki levofloksacina, sta razmerji Cmax/MIC in AUC/MIC (Cmax = največja koncentracija na mestu okužbe, AUC = površina pod krivuljo (area under the curve) in MIC = minimalna inhibitorna koncentracija (minimal inhibitory concentration)).
English: The use of inhaled medicinal products may induce a cough reflex.
Slovenian: Uporaba inhalacijskih zdravil lahko izzove refleks kašlja.
English: The renal clearance of levofloxacin was reduced by cimetidine (24%) and probenecid (34%).
Slovenian: Ledvični očistek levofloksacina zmanjšata tako cimetidin (24%) kot tudi probenecid (34%).
English: Sit the patient in a relaxed, upright position.
Slovenian: Bolnik naj sedi v sproščenem, pokončnem položaju.
English: In patients treated with levofloxacin, determination of opiates in urine may give false-positive results.
Slovenian: Pri bolnikih, zdravljenih s levofloksacinom, so lahko rezultati določanja opiatov v urinu lažno pozitivni.
English: To conduct a non-interventional post-authorisation safety study in a registry of patients with cystic fibrosis to investigate the long term safety profile of Quinsair in normal clinical practice in the European Union.
Slovenian: Izvedba neintervencijske študije varnosti po pridobitvi dovoljenja za promet z zdravilom v registru bolnikov s cistično fibrozo za preučitev dolgoročnega profila varnosti za zdravilo Quinsair v običajni klinični praksi v Evropski uniji.
English: These metabolites account for ˂ 5% of the dose following systemic administration and are excreted in urine.
Slovenian: Ta dva presnovka predstavljata ˂ 5% odmerka po sistemski uporabi in se izločita z urinom.
English: Dornase alfa;
Slovenian: 2. dornaza alfa,
English: This medicine does not require any special temperature storage conditions.
Slovenian: Za shranjevanje zdravila niso potrebni posebni temperaturni pogoji.
English: It may be necessary to confirm positive opiate screens by more specific methods.
Slovenian: Za potrditev pozitivnih izsledkov opiatov je morda treba uporabiti bolj specifično metodo.
English: Bacteria can become resistant to treatment with an antibiotic over time.
Slovenian: Sčasoma lahko bakterije postanejo odporne na zdravljenje z antibiotikom.
English: 7) Once complete, open the medicine cap to ensure all of the medicine has been used.
Slovenian: 7) Po koncu odprite pokrovček za zdravilo in preverite, ali ste porabili vse zdravilo.
English: Following oral and intravenous administration, levofloxacin is eliminated relatively slowly from the plasma (t1/2: 6 to 8 hours).
Slovenian: Po peroralni in intravenski uporabi se levofloksacin relativno počasi izloča iz plazme (t1/2 : 6 do 8 ur).
English: Once an ampoule is opened, the contents should be used immediately (see section 6.6).
Slovenian: Vsebino odprte ampule je treba uporabiti takoj (glejte poglavje 6.6).
English: Anxiety*, Depression*
Slovenian: anksioznost*, depresija*
English: Elimination is primarily by the renal route (> 85% of the dose following oral or intravenous administration).
Slovenian: Primarna pot izločanja je skozi ledvice (> 85% odmerka po peroralnem ali intravenskem dajanju).
English: How do I use the Zirela Nebuliser System?
Slovenian: Kako naj uporabljam sistem nebulatorja Zirela?
English: if you have experienced a previous episode of aortic dissection (a tear in the aorta wall).
Slovenian: če ste že kdaj doživeli epizodo aortne disekcije (raztrganina aortne stene);
English: - Do not swallow the liquid in the ampoule.
Slovenian: - Tekočine v ampuli ne smete zaužiti.
English: However, two cases of arthralgia have been observed in children in clinical studies with Quinsair and long-term safety data are missing especially considering the effects on cartilage observed in animals.
Slovenian: Vendar pa so pri otrocih v kliničnih študijah z zdravilom Quinsair opazili dva primera artralgije, dolgoročni podatki o varnosti pa manjkajo, zlasti ob upoštevanju učinkov na hrustanec, ki so jih ugotovili pri živalih.
English: * Adverse events with uncertain relatedness to Quinsair but which are known to be associated with systemic administration of levofloxacin and/or are plausibly associated with Quinsair and were reported more frequently than with placebo in clinical studies.
Slovenian: * Neželeni učinki, ki niso zagotovo povezani z zdravilom Quinsair, vendar je znano, da so povezani s sistemsko uporabo levofloksacina in/ali so verjetno povezani z zdravilom Quinsair ter so bili v kliničnih študijah poročani pogosteje kot pri placebu.
English: - A disease causing muscle weakness and fatigue called myasthenia gravis.
Slovenian: - Bolezen, ki povzroča mišično šibkost in utrujenost, imenovana miastenija gravis.
English: Median time to pulmonary exacerbation
Slovenian: Mediani čas do pljučnega poslabšanja
English: b LS Mean difference for Quinsair minus placebo.
Slovenian: b Povprečna razlika LS za zdravilo Quinsair minus placebo.
English: Tell your doctor if you are taking any of the following medicines: - Vitamin K antagonists such as warfarin (used to prevent blood clots).
Slovenian: Obvestite zdravnika, če uporabljate katero od naslednjih zdravil: - Antagoniste vitamina K, kot je varfarin (uporablja se za preprečevanje krvnih strdkov).
English: Stop using Quinsair and tell your doctor immediately: - if you experience pain, stiffness and/or swelling in your joints - if you develop problems with your liver.
Slovenian: Prenehajte uporabljati zdravilo Quinsair in takoj povejte zdravniku: - če se pojavi bolečina, togost in/ali oteklost sklepov - če se razvijejo težave z jetri.
English: Following systemic administration, there were no significant differences in levofloxacin pharmacokinetics between young and elderly subjects except those associated with age-related decreases in creatinine clearance.
Slovenian: Po sistemski uporabi ni bilo značilnih razlik v farmakokinetiki levofloksacina med mlajšimi in starejšimi osebami, razen tistih, ki so povezane z zmanjšanjem očistka kreatinina zaradi starosti.
English: - Superinfections
Slovenian: - Superinfekcije
English: - Nerve damage
Slovenian: - Poškodba živcev
English: A few drops of medicine may remain at the bottom of the reservoir at the end of treatment.
Slovenian: Na dnu vsebnika ob koncu zdravljenja lahko ostane nekaj kapljic zdravila.
English: The medicine comes in small 3 ml plastic ampoules.
Slovenian: Zdravilo je na voljo v majhnih 3 ml plastičnih ampulah.
English: You must inhale and exhale through the mouthpiece as before.
Slovenian: Kot prej morate vdihavati in izdihavati skozi ustnik.
English: Before taking this medicine
Slovenian: Pred uporabo tega zdravila
English: What Quinsair is and what it is used for
Slovenian: Kaj je zdravilo Quinsair in za kaj ga uporabljamo
English: Ask the patient to inhale and exhale through the mouthpiece until the treatment is finished.
Slovenian: Bolnika prosite, naj vdihava in izdihava skozi ustnik, dokler ni zdravljenje končano.
English: Quinsair may make your skin become more sensitive to sunlight.
Slovenian: Zdravilo Quinsair lahko povzroči večjo občutljivost kože na sončno svetlobo.
English: The mean post-dose sputum concentrations were approximately 500-1900 µg/ml and were approximately 400-1700 times higher than those observed in serum.
Slovenian: Povprečne koncentracije v sputumu po odmerku so bile približno 500-1.900 µg/ml in približno 400-1.700-krat višje kot v serumu.
English: Via Palermo, 26/A 43122 Parma
Slovenian: Chiesi Farmaceutici S.p.A, Via Palermo, 26/A 43122 Parma
English: The doses should be inhaled as close as possible to 12 hours apart.
Slovenian: Odmerke je treba inhalirati s presledkom, čim bližjim 12-urnemu.
English: System organ class Very common
Slovenian: Organski sistem Zelo pogosti
English: Pharmacokinetic parameter
Slovenian: Farmakokinetični parametri
English: 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.
Slovenian: Levofloksacin je treba prekiniti takoj ob prvih znakih ali simptomih kakršnih koli resnih neželenih učinkov, bolniku pa je treba svetovati, naj se posvetuje z zdravnikom, ki mu je zdravilo predpisal.
English: 5th Inhaled steroids
Slovenian: 5. inhalirani steroidi.
English: Pharmacotherapeutic group: antibacterials for systemic use, fluoroquinolones ATC code: J01MA12
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje bakterijskih infekcij, fluorokinoloni Oznaka ATC: J01MA12
English: The most frequently reported adverse reactions were cough/productive cough (54%), dysgeusia (30%) and fatigue/asthenia (25%).
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali, so bili kašelj/produktivni kašelj (54%), disgevzija (30%) in utrujenost/astenija (25%).
English: It belongs to the group of antibiotics called fluoroquinolones.
Slovenian: Sodi v skupino antibiotikov, imenovanih fluorokinoloni.
English: When do I use it?
Slovenian: Kdaj naj zdravilo uporabim?
English: If the contents of the ampoule are swallowed, don't worry but tell your doctor as soon as possible.
Slovenian: Če vsebino ampule zaužijete, ne skrbite, a to čim prej povejte zdravniku.
English: Do not take any medicines to treat your diarrhoea without first checking with your doctor.
Slovenian: Ne uporabljajte nobenih zdravil za zdravljenje driske, ne da bi se prej posvetovali z zdravnikom.
English: How do I prepare my Nebuliser System to inhale the medicine?
Slovenian: Kako naj pred inhaliranjem zdravila pripravim sistem nebulatorja?
English: However if there are more than a few drops left, replace the medicine cap and restart treatment.
Slovenian: Če pa ostane več kot le nekaj kapljic, zaprite pokrov in ponovno začnite z zdravljenjem.
English: There is a limited amount of data from the use of levofloxacin in pregnant women.
Slovenian: Podatkov o uporabi levofloksacina pri nosečnicah je malo.
English: Inhaling Quinsair at the same time each day will help you remember when to take your medicine.
Slovenian: Če boste zdravilo Quinsair vsak dan inhalirali ob istem času, si boste lažje zapomnili, kdaj morate zdravilo uporabiti.
English: Patients with glucose-6-phosphate dehydrogenase deficiency
Slovenian: Bolniki s pomanjkanjem glukoza-6-fosfat-dehidrogenaze
English: This means that Quinsair should not be used to prevent lung infections.
Slovenian: To pomeni, da se zdravilo Quinsair ne sme uporabljati za preprečevanje pljučnih okužb.
English: The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, patients receiving daily doses of 1000 mg levofloxacin, and those treated concurrently with corticosteroids.
Slovenian: Tveganje za tendinitis in pretrganje tetive je povečano pri starejših bolnikih, bolnikih z okvaro ledvic, bolnikih s presajenimi organi, bolnikih, ki prejemajo dnevne odmerke 1.000 mg levofloksacina, in tistih, ki se sočasno zdravijo s kortikosteroidi.
English: The Manufacturer's Instructions for Use will give full details on cleaning and disinfecting.
Slovenian: V navodilih izdelovalca za uporabo najdete vse podrobnosti o čiščenju in razkuževanju.
English: Inner box
Slovenian: Notranja škatla
English: - Difficulty in breathing which can range from mild to severe (bronchospasm).
Slovenian: - Težave z dihanjem, ki so lahko blage do hude (bronhospazem).
English: However if it is nearly the time for your next dose, skip the missed dose.
Slovenian: Če je že skoraj čas za naslednji odmerek, preskočite odmerek, ki ste ga pozabili uporabiti.
English: The affected limb(s) should be appropriately treated (e.g. immobilisation).
Slovenian: Prizadeto okončino ali okončine je treba ustrezno obravnavati (npr. imobilizacija).
English: Transient vision loss
Slovenian: prehodna izguba vida
English: Quinsair must not be used whilst pregnant or breast-feeding.
Slovenian: Zdravila Quinsair se ne sme uporabljati med nosečnostjo ali dojenjem.
English: IV = intravenous; QD = quaque die (once a day); BID = bis in die (twice a day) * Predicted value from population PK analysis in CF patients ** Healthy males 18-53 years old
Slovenian: = intravensko; QD = quaque die (enkrat na dan); BID = bis in die (dvakrat na dan) * Napovedana vrednost iz FK populacijske analize pri bolnikih s CF ** Zdravi moški, stari 18-53 let
English: Get urgent medical treatment immediately if you notice a severe allergic reaction after inhaling Quinsair.
Slovenian: Takoj poiščite nujno zdravljenje, če po inhaliranju zdravila Quinsair opazite hudo alergijsko reakcijo.
English: Haemodialysis, including peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD), are not effective in removing levofloxacin from the body.
Slovenian: Hemodializa, vključno s peritonealno dializo in kontinuirano ambulantno peritonealno dializo (CAPD), ni učinkovita pri odstranjevanju levofloksacina iz telesa.
English: In the “crimped area” on either side of the ampoule tail LOT
Slovenian: "Stisnjen del" na obeh straneh spodnjega dela ampule Lot
English: Furthermore, clinical data do not suggest interaction with P-glycoprotein (P-gp) substrates such as digoxin.
Slovenian: Klinični podatki nadalje ne kažejo na medsebojno delovanje s substrati P-glikoproteina (P-gp), kot je digoksin.
English: There is insufficient information on the excretion of levofloxacin in human milk; however, other fluoroquinolones are excreted in breast milk.
Slovenian: Ni dovolj podatkov o izločanju levofloksacina v materino mleko, vendar se drugi fluorokinoloni izločajo v materino mleko.
English: Caution is recommended if levofloxacin is used in psychotic patients or in patients with a history of psychiatric disease.
Slovenian: Previdnost se priporoča ob uporabi levofloksacina pri psihotičnih bolnikih ali pri bolnikih s psihiatrično boleznijo v anamnezi.
English: 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.
Slovenian: Redko se lahko pojavijo simptomi poškodbe živcev (nevropatija), kot so bolečina, skelenje, mravljinčenje, odrevenelost in/ali šibkost, zlasti v stopalih in nogah ali dlaneh in rokah.
English: Treatment of these patients with levofloxacin should only be initiated in the absence of alternative treatment options and after careful benefit/risk assessment (see also section 4.3).
Slovenian: Zdravljenje teh bolnikov z levofloksacinom se sme uvesti le v primeru, da ni drugih možnosti zdravljenja, in po skrbni oceni razmerja med koristmi in tveganji (glejte tudi poglavje 4.3).
English: Diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with levofloxacin (including several weeks after treatment), may be symptomatic of Clostridium difficile-associated disease (CDAD).
Slovenian: Driska, zlasti huda, dolgotrajna in/ali krvava, med zdravljenjem z levofloksacinom ali po njem (vključno z več tedni po zdravljenju) je lahko znak bolezni, povezane s Clostridium difficile.
English: If aerosol mist does not begin to flow, please refer to the Zirela Manufacturer's Instructions for Use for help.
Slovenian: Če aerosol ne začne pršeti, glejte navodila izdelovalca za sistem Zirela za pomoč.
English: If you forget to use Quinsair
Slovenian: Če ste pozabili uporabiti zdravilo Quinsair
English: Cross-resistance between levofloxacin and other fluoroquinolones is observed.
Slovenian: Opazili so navzkrižno odpornost med levofloksacinom in drugimi fluorokinoloni.
English: Weight decrease was reported as an adverse event during clinical studies, but was primarily thought to be disease rather than drug-related.
Slovenian: Med kliničnimi študijami so kot o neželenem učinku poročali o zmanjšanju telesne mase, vendar prevladuje mnenje, da je to povezano z boleznijo in ne zdravilom.
English: You should avoid prolonged exposure to sunlight or strong sunlight and should not use sunbeds or any other UV lamps whilst using Quinsair and for 48 hours after stopping treatment.
Slovenian: Preprečite dolgotrajno izpostavljanje sončni svetlobi ali močni sončni svetlobi in ne uporabljajte solarijev ali drugih UV-svetilk, medtem ko se zdravite z zdravilom Quinsair in še 48 ur po prenehanju zdravljenja.