FrancophonIA/ELRC3.0 huggingface dataset:
English: Only after reconstitution Shake well before use.
Slovenian: peroralna uporaba uporaba samo po rekonstituciji Pred uporabo močno pretresite.
English: • caffeine
Slovenian: − kofeina
English: Severely impaired renal function leads to increased half lives of ciprofloxacin of up to 12 h.
Slovenian: Hude okvare ledvic zvečajo razpolovni čas ciprofloksacina do 12 ur.
English: Ciprofloxacin Bayer may increase the levels of the following medicines in your blood:
Slovenian: Zdravilo Ciprofloksacin Bayer lahko v krvi zveča vrednosti naslednjih zdravil:
English: Long-term safety profile of ciprofloxacin to treat upper-respiratory tract infections The CHMP requested that applicant/MAH provide the rationale for a 3-month treatment duration of upper respiratory tract infections and substantiate the long-term safety of the drug in such a prolonged use.
Slovenian: Dolgoročni varnostni profil ciprofloksacina pri zdravljenju okužb zgornjega dela dihal CHMP je predlagatelja/imetnika dovoljenja za promet z zdravilom zaprosil, naj predloži utemeljitev za zdravljenje zgornjega dela dihal v trajanju treh mesecev in podkrepi dolgoročno varnost zdravila pri tako dolgotrajni uporabi.
English: Reclose the bottle properly after use according to the instructions on the cap.
Slovenian: Zaprite stekleničko točno po navodilu na zaporki.
English: • mineral supplements
Slovenian: − mineralne pripravke
English: The use of ciprofloxacin for specific severe infections other than those mentioned above has not been evaluated in clinical trials and the clinical experience is limited.
Slovenian: Uporabo ciprofloksacina pri hudih okužbah, ki niso omenjene zgoraj, niso ocenjevali v kliničnih preskušanjih.
English: If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately.
Slovenian: Če imate okužbo s simptomi zvišane telesne temperature in resnim poslabšanjem vašega splošnega stanja, ali zvišano telesno temperaturo s simptomi lokalne okužbe (npr. vneto grlo, žrelo, usta) ali težave s sečili, morate takoj obiskati zdravnika.
English: Slow infusion into a large vein will minimise patient discomfort and reduce the risk of venous irritation.
Slovenian: Počasno infundiranje v veliko veno bo zmanjšalo nevarnost vnetja vene, postopek bo za bolnika bolj primeren.
English: • Hypersensitivity to the active substance, to other quinolones or to any of the excipients (see section 6.1).
Slovenian: • preobčutljivost za zdravilno učinkovino, druge kinolone ali katerokoli pomožno snov (glejte poglavje 6.1)
English: On concurrent administration of ciprofloxacin and caffeine or pentoxifylline (oxpentifylline), raised serum concentrations of these xanthine derivatives were reported.
Slovenian: Pri sočasni uporabi ciprofloksacina in kofeina ali pentoksifilina (okspentifilin) so poročali o zvečanih serumskih koncentracijah teh ksantinskih derivatov.
English: Using Ciprofloxacin Bayer together with these medicines can influence the therapeutic effect of these medicines.
Slovenian: Uporaba zdravila Ciprofloksacin Bayer sočasno s temi zdravili lahko vpliva na terapevtski učinek teh zdravil.
English: In juvenile and prenatal animals exposed to quinolones, effects on immature cartilage have been observed, thus, it cannot be excluded that the drug could cause damage to articular cartilage in the human immature organism / foetus (see section
Slovenian: Pri mladih in prenatalnih živalih, ki so bile izpostavljene kinolonom, so opažali učinke na nerazvitem hrustancu, zato se možnosti poškodb sklepnega hrustanca pri nerazvitih organizmih/fetusih ne da zanesljivo izključiti (glejte poglavje 5.3).
English: Safety data from a randomised double-blind study on ciprofloxacin use in children (ciprofloxacin: n=335, mean age = 6.3 years; comparators: n=349, mean age = 6.2 years; age range = 1 to 17 years) revealed an incidence of suspected drug-related arthropathy (discerned from joint-related clinical signs and symptoms) by Day +42 of 7.2% and 4.6%.
Slovenian: Podatki o varnosti iz randomizirane, dvojno slepe študije o uporabi ciprofloksacina pri otrocih (ciprofloksacin: n = 335, povprečna starost = 6,3 leta; primerjalno zdravilo: n = 349, povprečna starost = 6,2 leti, starost = 1 do 17 let) so pokazali, da se z zdravilom domnevno povezana artropatija (glede na klinične znake in simptome) pojavi do 42. dneva v 7,2 % oz. 4,6 %.
English: Anaerobic micro-organisms Peptostreptococcus spp.
Slovenian: anaerobni mikroorganizmi Peptostreptococcus spp.
English: Tell your doctor immediately, if any of the following occurs during treatment with Ciprofloxacin Bayer.
Slovenian: Obvestite svojega zdravnika, če se kaj od navedenega pojavi med zdravljenjem z zdravilom Ciprofloksacin Bayer.
English: Ciprofloxacin is known to be a moderate inhibitor of the CYP 450 1A2 iso-enzymes.
Slovenian: Ciprofloksacin je srednje močni zaviralec encimskega sistema CYP450 1A2.
English: Pharmacotherapeutic group: Fluoroquinolones, ATC code: J01MA02
Slovenian: Farmakoterapevtska skupina: fluorokinoloni, oznaka ATC: J01MA02
English: The CHMP was of the opinion that the therapeutic indication “selective digestive decontamination in immuno-suppressed patients” could not be accepted, as there is an absence of specific data submitted by the Applicant/MAH to support such therapeutic use and there is no consensus in the scientific community on the use ciprofloxacin in such indication.
Slovenian: CHMP je izrazil mnenje, da terapevtska indikacija „selektivna dekontaminacija prebavil pri bolnikih z oslabljenim imunskim sistemom“ ni sprejemljiva, saj predlagatelj/imetnik dovoljenja za promet z zdravilom ni predložil zadostnih specifičnih podatkov, ki bi takšno terapevtsko uporabo potrjevali, prav tako pa v strokovni javnosti ni oblikovanega soglasja o uporabi ciprofloksacina pri tej indikaciji.
English: Tizanidine
Slovenian: Tizanidin
English: In such cases, ciprofloxacin should immediately be discontinued, and an appropriate therapy initiated.
Slovenian: V takih primerih je treba zdravljenje s ciprofloksacinom takoj prekiniti in pričeti z ustreznim zdravljenjem bolnika.
English: What Ciprofloxacin Bayer is and what it is used for Before you take Ciprofloxacin Bayer How to take Ciprofloxacin Bayer Possible side effects
Slovenian: Kaj je zdravilo Ciprofloksacin Bayer in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Ciprofloksacin Bayer Kako jemati zdravilo Ciprofloksacin Bayer Možni neželeni učinki
English: Following an intravenous infusion of ciprofloxacin the mean maximum serum concentrations were achieved at the end of infusion.
Slovenian: Po intravenski uporabi ciprofloksacina je povprečna Najvišja serumska koncentracija ciprofloksacina ob koncu infundiranja.
English: Resistant
Slovenian: Odpornost
English: The following medicines are known to interact with Ciprofloxacin Bayer in your body.
Slovenian: Za naslednja zdravila je znano, da v telesu medsebojno delujejo z zdravilom Ciprofloksacin Bayer.
English: Ciprofloxacin works by killing bacteria that cause infections.
Slovenian: Ciprofloksacin uničuje določene vrste bakterij, ki povzročajo okužbe.
English: Simultaneous administration of ciprofloxacin and phenytoin may result in increased or reduced serum levels of phenytoin such that monitoring of drug levels is recommended.
Slovenian: Sočasna uporaba ciprofloksacina in fenitoina lahko povzroči zvišanje ali znižanje serumskih ravni fenitoina zato se priporoča skrbno spremljanje ravni zdravila.
English: Total duration of treatment (including switch to oral therapy as soon as possible)
Slovenian: skupno trajanje zdravljenja (tudi peroralno zdravljenje takoj, ko je možno)
English: Incompatibility appears with all infusion solutions/drugs that are physically or chemically unstable at the pH of the solution (e.g. penicillins, heparin solutions), especially in combination with solutions adjusted to an alkaline pH (pH of the ciprofloxacin infusion solutions: 3.5-4.6).
Slovenian: Do nekompatibilnosti pride z vsemi raztopinami za infundiranje/zdravili, ki so pri vrednosti pH raztopine ciprofloksacina fizikalno ali kemijsko nestabilne(a) (npr. penicilini, raztopine heparina), zlasti pri kombinacijah z raztopinami, prilagojenimi na alkalno vrednost pH (vrednost pH raztopin za infundiranje ciprofloksacina je 3,5 do 4,6).
English: - nausea, diarrhoea - joint pains in children
Slovenian: − slabost, driska − bolečine v sklepih pri otrocih
English: Film-coated tablet [To be completed nationally]
Slovenian: Filmsko obložena tableta [Izpolni država članica]
English: If possible, take the oral suspension or the box with you to show the doctor.
Slovenian: Če je mogoče, vzemite s seboj peroralno suspenzijo ali škatlo in jo pokažite zdravniku.
English: Depression Hallucinations
Slovenian: nočne more depresija halucinacije
English: In line with the data submitted, the benefit/risk in prophylaxis was regarded as favourable in patients with neutrophil count less than 1000/mm3.
Slovenian: Predloženi podatki namreč kažejo, da je razmerje med koristjo in tveganjem v primeru profilakse pri bolnikih s številom belih krvničk v krvi manjšim od 1000/mm3.
English: You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efficacy if you do not respect appropriate:
Slovenian: Z nepravilnim jemanjem se lahko povzroči tudi, da se razvije odpornost bakterij in se zato podaljša vaše zdravljenje ali zmanjša učinkovitost antibiotiokov.
English: Due to its neurological effects, ciprofloxacin may affect reaction time.
Slovenian: Zaradi nevroloških učinkov zdravilo ciprofloksacin lahko vpliva na odzivne sposobnosti.
English: Methotrexate The concomitant use of ciprofloxacin with methotrexate is not recommended (see section 4.5).
Slovenian: Metotreksat Sočasna uporaba ciprofloksacina in metotreksata se ne priporoča (glej poglavje 4.5).
English: • Pelvic inflammatory disease including cases due to Neisseria gonorrhoeae In the above genital tract infections when thought or known to be due to Neisseria gonorrhoeae it is particularly important to obtain local information on the prevalence of resistance to ciprofloxacin and to confirm susceptibility based on laboratory testing.
Slovenian: • medenična vnetna bolezen, tudi če jo povzroča Neisseria gonorrhoeae Pri zgoraj navedenih genitalnih okužbah, ko je dokazano ali pa obstaja sum, da je povzročitelj Neisseria gonorrhoae, je posebno pomembno, da se upošteva lokalne podatke o prevalenci odpornosti na ciprofloksacin.
English: The CHMP raised concerns on the following wording in Section 4.1 of the SPC : “Other severe infections in accordance with Official guidance, after careful benefit-risk evaluation when other treatments cannot be used, or after failure to conventional therapy and when the microbiological documentation can justify a ciprofloxacin use.” It was deemed to describe clinical situations in which the use of ciprofloxacin may be considered in spite of a missing indication, in children and adolescents.
Slovenian: Uporaba ciprofloksacina pri otrocih in mladostnikih CHMP je izrazil zadržke glede ubeseditve poglavja 4.1 v povzetku glavnih značilnosti zdravila: „Druge hude okužbe v skladu z uradnimi smernicami, po pozorni ocenitvi razmerja med koristjo in tveganjem, kadar ni mogoče uporabiti drugih zdravljenj ali po neuspešni konvencionalni terapiji in kadar mikrobiološka dokumentacija upravičuje uporabo ciprofloksacina.“ Potrebno je bilo opisati klinične situacije, v katerih je uporaba ciprofloksacina pri otrocih in mladostnikih možna navkljub nezadostnim indikacijam.
English: the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Ciprofloxacin Bayer and associated names (see Annex I).
Slovenian: je CHMP priporočil dopolnitev dovoljenj za promet z zdravilom Ciprofloxacin Bayer in z njim povezana imena, za katera so v Dodatku III določeni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo (glejte Dodatek I).
English: 400 mg twice daily 60 days from the confirmation of Bacillus anthracis exposure
Slovenian: 400 mg dvakrat na dan 60 dni od potrjene izpostavljenosti Bacillus anthracis
English: 500 mg twice daily 60 days from the confirmation of Bacillus anthracis exposure
Slovenian: 500 mg dvakrat na dan 60 dni od potrjene izpostavljenosti Bacillus anthracis
English: At any sign of tendinitis (e.g. painful swelling, inflammation), ciprofloxacin treatment should be discontinued.
Slovenian: Če se pojavijo znaki tendinitisa (npr. boleča oteklina, vnetje), je treba prekiniti zdravljenje s ciprofloksacinom.
English: Single doses of 100-750 mg produced dose-dependent maximum serum concentrations (Cmax) between 0.56 and 3.7 mg/L.
Slovenian: Po enkratnih odmerkih od 100 do 750 mg so Najvišje serumske koncentracije med 0,56 in 3,7 mg/l.
English: The applicant/MAH provided documentation to support the use of ciprofloxacin as a valuable therapeutic option both prophylaxis and treatment of febrile neutropenic patients.
Slovenian: Predlagatelj/imetnik dovoljenja za promet z zdravilom je predložil dokumentacijo v podporo uporabi ciprofloksacina kot pomembne terapevtske možnosti tako za profilakso kot zdravljenje bolnikov z vročinsko nevtropenijo.
English: Propionibacterium acnes INHERENTLY RESISTANT ORGANISMS Aerobic Gram-positive micro-organisms Actinomyces
Slovenian: Propionibacterium acnes ODPORNI ORGANIZMI aerobni, po Gramu pozitivni mikroorganizmi Actinomyces
English: Ciproxin oral suspension oral use
Slovenian: Ciproxin peroralna suspenzija peroralna uporaba
English: Very rare side effects (less than 1 in every 10,000 people are likely to get these):
Slovenian: Zelo redki (manj kot 1 od 10.000 bolnikov)
English: Ciprofloxacin should be co-administered with another appropriate antibacterial agent unless ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded.
Slovenian: Ciprofloksacin je treba aplicirati hkrati z ustreznim antibakterijskim zdravilom, razen če se lahko izključi za ciprofloksacin odporno Neisseria gonorrhoeae.
English: Taking Ciprofloxacin Bayer with food and drink
Slovenian: Jemanje zdravila Ciprofloksacin Bayer skupaj s hrano in pijačo
English: Restriction of the indication “Infections of the lower respiratory tract” The CHMP noted that ciprofloxacin was not suited for therapy of pneumococci and its efficacy against chlamydia was worse compared to other fluoroquinolones such as levofloxacin or moxifloxacin.
Slovenian: Odbor za zdravila za uporabo v humani medicini je navedel, da ciprofloksacin ni primeren za terapijo pnevmokokov ter da je njegova učinkovitost pri klamidiji slabša v primerjavi z drugimi fluorokinoloni, kot sta na primer levofloksacin ali moksifloksacin.
English: Aerobic Gram-negative micro-organisms Aeromonas spp.
Slovenian: aerobni, po Gramu negativni mikroorganizmi Aeromonas spp.
English: Comparison of the pharmacokinetic parameters for a twice a day and three times a day intravenous dose regimen indicated no evidence of drug accumulation for ciprofloxacin and its metabolites.
Slovenian: uporabi zdravila dvakrat in trikrat na dan ne potrjuje kopičenja ciprofloksacina in njegovih presnovkov.
English: Excretion of ciprofloxacin (% of dose)
Slovenian: izločanje ciprofloksacina (% odmerka)
English: You can take the tablets at mealtimes or between meals.
Slovenian: Tablete lahko jemljete ne glede na obroke hrane.
English: DATE OF REVISION OF THE TEXT {MM/YYYY} [To be completed nationally]
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA: {MM/LLLL} [Izpolni država članica]
English: Ciprofloxacin Bayer is used in adults to treat the following bacterial infections:
Slovenian: Zdravilo Ciprofloksacin Bayer se pri odraslih uporablja za zdravljenje naslednjih bakterijskih okužb:
English: Therefore, the following statement was recommended in Section 4.2 of the SPC: “ciprofloxacin should be co-administered with appropriate antibacterial agents in accordance to official guidance”.
Slovenian: Tako je v poglavju 4.2 povzetka glavnih značilnosti zdravila priporočena vključitev naslednje izjave: „v skladu z uradnimi smernicami naj se ciprofloksacin uporablja hkrati z ustreznimi protimikrobnimi snovmi“.
English: In patients with low-risk neutropenic fever, a 750 mg bid ciprofloxacin regimen can also be used.
Slovenian: Pri bolnikih z nizkim tveganjem nevtropenične vročine, se prav tako lahko uporablja 750 mg odmerek z bid odmerjanjem.
English: Ciprofloxacin is a broad spectrum antibacterial agent that belongs to the fluoroquinolone family.
Slovenian: Ciprofloksacin je protibakterijska učinkovina širokega spektra, ki sodi v skupino fluorokinolonov.
English: • Gonococcal urethritis and cervicitis (only for oral formulations)
Slovenian: • gonoroični uretritis in cervicitis (le za peroralne pripravke)
English: Injection Site Reaction
Slovenian: Reakcije na mestu injiciranja
English: • Severe, sudden allergic reaction (an anaphylactic reaction/shock, angio-oedema).
Slovenian: − takojšnje hude alergijske reakcije (anafilaktične reakcije/šok, edem žil).
English: • Acute exacerbations of chronic sinusitis, especially if these are caused by Gram-negative bacteria
Slovenian: • akutna eksacerbacija kroničnega sinusitisa, zlasti če so njegovi povzročitelji po Gramu negativne bakterije
English: Therefore, the CHMP agreed that the safety data did not show any evidence that the safety profile of ciprofloxacin is affected by a longer treatment duration up to 3 months.
Slovenian: Tako se je CHMP strinjal, da varnostni podatki ne kažejo nobenih dokazov o vplivu dolgotrajnega zdravljenja s ciprofloksacinom, do treh mesecev, na varnostni profil zdravila.
English: It is preferable to avoid the use of Ciprofloxacin Bayer during pregnancy.
Slovenian: Po možnosti se izogibajte uporabi zdravila Ciprofloksacin Bayer med nosečnostjo.
English: Treatment of infections due to certain bacteria (e.g. Pseudomonas aeruginosa, Acinetobacter or Staphylococci) may require higher ciprofloxacin doses and co-administration with other appropriate antibacterial agents.
Slovenian: Za zdravljenje okužb, ki so jih povzročili Pseudomonas aeruginosa, Acinetobacter ali Staphylococci, so lahko potrebni večji odmerki ciprofloksacina in sočasna uporaba drugih ustreznih antibakterijskih zdravil.
English: 200-400 mg every 24 h
Slovenian: 200 - 400 mg vsakih 24 h
English: Effects of ciprofloxacin on other medicinal products:
Slovenian: Vpliv ciprofloksacina na druga zdravila:
English: The pharmacokinetics of ciprofloxacin oral suspension 50 mg/mL and 100 mg/mL are similar to those of tablets.
Slovenian: Farmakokinetika ciprofloksacina v peroralni suspenziji 50 mg/ml in 100 mg/ml je enaka kot farmakokinetika ciprofloksacina v tabletah.
English: • have a history of tendon problems during previous treatment with antibiotics such as
Slovenian: − ste imeli težave s tetivami pri prejšnjih zdravljenjih z antibiotiki, ki so podobni zdravilu
English: 6.6 Special precautions for disposal and other handling The small bottle contains the active substance and the large bottle contains the solvent.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Majha steklenička vsebuje zdravilno učinkovino, plastenka vsebuje suspenzijo.
English: Infection of bone and joint infections due to Gram-positive bacteria:
Slovenian: Okužbe kosti in sklepov zaradi Gram pozitivne bakterije:
English: If you notice any symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or tenderness of the stomach, stop taking Ciprofloxacin Bayer and contact your doctor immediately.
Slovenian: Če opazite katerikoli simptom kot so izguba apetita, zlatenica (porumenelost kože), temen seč, srbenje ali napetost trebuha, prekinite jemati zdravilo Ciprofloksacin Bayer in se posvetujte s svojim zdravnikom.
English: Do not take Ciprofloxacin Bayer together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see Section 2: "Do not take Ciprofloxacin Bayer").
Slovenian: Ne jemljite zdravila Ciprofloksacin Bayer hkrati s tizanidinom, ker se lahko pojavijo neželeni učinki, npr. nizek krvni tlak, zaspanost (glejte poglavje 2: Ne jemljite zdravila Ciprofloksacin Bayer).
English: Ciprofloxacin Bayer is an antibiotic belonging to the fluoroquinolone family.
Slovenian: Zdravilo Ciprofloksacin Bayer je antibiotik iz skupine fluorokinolonov.
English: Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin)
Slovenian: skupno trajanje zdravljenja (lahko vključuje tudi začetno parenteralno zdravljenje s ciprofloksacinom)
English: The frequency analysis takes into account data from both oral and intravenous administration of ciprofloxacin.
Slovenian: Pri pogostnosti so upoštevani podatki o peroralni in intravenski uporabi ciprofloksacina.
English: 1% of the dose is excreted via the biliary route.
Slovenian: Z žolčem se izloči 1 % odmerka.
English: The pharmacokinetics of ciprofloxacin 250 mg and 500 mg oral suspension in single-dose sachets are similar to those of tablets.
Slovenian: Farmakokinetika ciprofloksacina 250 mg in 500 mg v peroralni suspenziji v vrečicah za enkratno uporabo je enaka kot farmakokinetika ciprofloksacina v tabletah.
English: The CHMP considered that the therapeutic indication “septicaemia due to Gram negative bacteria” could not be accepted as the Applicant/MAH did not provide reassurance on the fact that ciprofloxacin could be viewed as an adequate option in this severe situation with regards its level of activity and the available therapeutic alternatives.
Slovenian: CHMP je menil, da indikacija „septikemija zaradi Gram negativne bakterije“ ne more biti sprejemljiva saj predlagatelj/imetnik dovoljenja za promet z zdravilom ni predložil nobenih podatkov, ki bi potrjevali, da je ciprofloksacin glede na svojo raven delovanja ter ostale terapevtske možnosti lahko ustrezna izbira pri tej hudi bolezni.
English: Geriatric patients should receive a dose selected according to the severity of the infection and the patient`s creatinine clearance.
Slovenian: Starejšim bolnikom je treba odmerek zdravila prilagoditi glede na resnost bolezni in očistek kreatinina.
English: The graduated measuring spoon must be used for measuring the required prescribed amount of Ciprofloxacin oral suspension 100 mg/mL.
Slovenian: Graduirano merilno žličko je treba uporabiti za odmerjanje zahtevane predpisane količine 10 % peroralne suspenzije ciprofloksacina.
English: There may be a particular risk of selecting for ciprofloxacin-resistant bacteria during extended durations of treatment and when treating nosocomial infections and/or infections caused by Staphylococcus and Pseudomonas species.
Slovenian: Tveganje je večje posebno med dolgotrajnim zdravljenjem, pri zdravljenju nozokomialnih okužb in/ali kadar so povzročitelji iz vrst Staphylococcus in Pseudomonas.
English: Ciprofloxacin should be used with caution in patients with myasthenia gravis (see section 4.8).
Slovenian: Ciprofloksacin je treba previdno uporabljati pri bolnikih z miastenijo gravis (glejte poglavje 4.8).
English: The graduated measuring spoon must be used for measuring the required prescribed amount of Ciprofloxacin oral suspension 50 mg/mL.
Slovenian: Graduirano merilno žličko je treba uporabiti za odmerjanje zahtevane predpisane količine 5 % peroralne suspenzije ciprofloksacina.
English: Increased amylase * These events were reported during the postmarketing period and were observed predominantly among patients with further risk factors for QT prolongation (see section 4.4).
Slovenian: amilaze * O teh neželenih učinkih so poročali v obdobju trženja in so jih opazili pretežno pri bolnikih pri katerih obstaja tveganje za podaljšanje intervala QT (glejte poglavje 4.4).