FrancophonIA/ELRC3.0 huggingface dataset:
English: Such compounds can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue (see section 4.4).
Croatian: Takvi spojevi mogu pojačati toksičnost aminoglikozida time što mijenjaju koncentracije antibiotika u serumu i tkivima (vidjeti dio 4.4).
English: Ampoules are packed in sachets, one sachet contains 8 ampoules which correspond with 4 days of treatment.
Croatian: Ampule su zapakirane u vrećice, s time da jedna vrećica sadrži 8 ampula, što odgovara količini potrebnoj za 4 dana liječenja.
English: • hyperventilating, low oxygen levels in your blood, sinusitis
Croatian: • hiperventilacija, niska razina kisika u krvi, upala sinusa
English: If you forget to use Vantobra and there are at least 6 hours to your next dose, use your dose as soon as you can.
Croatian: Ako zaboravite primijeniti Vantobra, a imate najmanje 6 sati vremena prije iduće doze, primijenite lijek što je prije moguće.
English: It acts primarily by disrupting protein synthesis leading to altered cell membrane permeability, progressive disruption of the cell envelope and eventual cell death.
Croatian: Prvenstveno djeluje tako da ometa sintezu proteina, što dovodi do promjena u propusnosti stanične membrane, progresivnog prekida stanične ovojnice i u konačnici do smrti stanice.
English: • Nebulisation should take place in a well ventilated room.
Croatian: • Nebulizaciju je potrebno provoditi u dobro prozračenoj sobi.
English: In the case of any overdose, the possibility of drug interactions with alterations in the elimination of Vantobra or other medicinal products should be considered.
Croatian: U slučaju bilo kakvog predoziranja, mora se uzeti u obzir mogućnost interakcije lijekova, s promjenama u eliminaciji lijeka Vantobra ili drugih lijekova.
English: Urea and creatinine levels should be reassessed after every 6 complete cycles of Vantobra therapy (180 days of nebulised aminoglycoside therapy).
Croatian: Vrijednosti uree i kreatinina moraju se ponovno provjeriti nakon svakih 6 dovršenih ciklusa terapije lijekom Vantobra (180 dana terapije nebuliziranim aminoglikozidom).
English: The following medicines can increase the risks of harmful effects occurring if they are given to you while you also take tobramycin or another aminoglycoside antibiotic given by injection:
Croatian: Sljedeći lijekovi mogu povećati rizik od pojave štetnih učinaka ako ih uzimate dok primate tobramicin ili drugi aminoglikozidni antibiotik koji se daje injekcijom:
English: Do not use the Tolero nebuliser handset for any other medicine.
Croatian: Nemojte koristiti ručni nebulizator Tolero ni za koji drugi lijek.
English: Outer box contains:
Croatian: Vanjska kutija sadrži:
English: If less than 6 hours remain to the next planned dose, the patient should wait for the next dose and not inhale more to make up for the missed dose.
Croatian: Ako je preostalo manje od 6 sati do sljedeće planirane doze, bolesnik mora čekati sljedeću dozu i ne inhalirati više ampula kako bi nadoknadio propuštenu dozu.
English: • It is best to have an interval as close as possible to 12 hours between doses, but this interval must be at least 6 hours.
Croatian: • Najbolje je održavati razmak između doza što je bliže 12 sati, no ovaj razmak mora biti najmanje 6 sati.
English: Do not stop using Vantobra unless your doctor tells you to do so, as your lung infection may not be controlled sufficiently and may become worse.
Croatian: Nemojte prestati primjenjivati Vantobra ako Vam Vaš liječnik nije tako savjetovao, jer Vaša plućna infekcija možda nije dovoljno kontrolirana te se može pogoršati.
English: These medicines may cause muscle weakness to appear or become worse.
Croatian: Ovi lijekovi mogu uzrokovati pojavu ili pogoršanje slabosti mišića.
English: Any unused medicinal product or waste material should be disposed off in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: Limited data from one controlled clinical study over one treatment cycle indicate that the improvement in lung function was maintained above baseline during the 28-day off-treatment period.
Croatian: Ograničeni podaci prikupljeni u jednom kontroliranom kliničkom ispitivanju tijekom jednog ciklusa liječenja ukazuju da je poboljšanje plućne funkcije održano iznad početne razine tijekom 28-dnevnog razdoblja neuzimanja lijeka.
English: • It is important that you keep using the medicine twice each day during your 28 days on treatment, and that you keep to the 28-day on / 28-day off cycle.
Croatian: • Važno je primjenjivati lijek dva puta svaki dan tijekom 28 dana liječenja, te se pridržavati ciklusa od 28 dana primjene / 28 dana bez primjene.
English: If you inhale too much Vantobra you may get a very hoarse voice.
Croatian: Ako inhalirate previše lijeka Vantobra, glas Vam može postati jako hrapav.
English: Systemic exposure following inhalation of Vantobra is very low (see section 5.2).
Croatian: Sistemska izloženost nakon inhalacije lijeka Vantobra vrlo je niska (vidjeti dio 5.2).
English: Long-term safety data are not available for Vantobra (see also section 5.1).
Croatian: Podaci o dugoročnoj sigurnosti za lijek Vantobra nisu dostupni (vidjeti i dio 5.1).
English: This means that Vantobra may not work as well as it should over time.
Croatian: To znači da s vremenom lijek Vantobra možda više neće djelovati kako bi trebao.
English: There was no difference in the safety profile between pediatric and adult patient population treated with Vantobra.
Croatian: Nije bilo razlike u sigurnosnom profilu između pedijatrijske populacije i populacije odraslih bolesnika koji su liječeni lijekom Vantobra.
English: There is no evidence that patients treated with up to 18 months with tobramycin nebuliser solution were at a greater risk for acquiring B. cepacia, S. maltophilia or A. xylosoxidans, than would be expected in untreated patients.
Croatian: Nema dokaza da su bolesnici liječeni otopinom tobramicina za nebulizator do najviše 18 mjeseci bili izloženi većem riziku od zaraze bakterijama B. cepacia, S. maltophilia ili A. xylosoxidans nego što se očekuje u neliječenih bolesnika.
English: A cycle of 28 days of active therapy (on-treatment period) and 28 days of rest from treatment (off-treatment period) should be maintained.
Croatian: Mora se provoditi ciklus od 28 dana aktivne terapije (razdoblje liječenja) i 28 dana bez primjene lijeka (razdoblje bez liječenja).
English: The episodes of tinnitus were transient and resolved without discontinuation of tobramycin therapy.
Croatian: Slučajevi tinitusa bili su prolazni i riješeni su bez prekida terapije tobramicinom.
English: Do not use Vantobra:
Croatian: Nemojte primjenjivati Vantobra:
English: Animal studies do not indicate a teratogenic effect of tobramycin (see section 5.3).
Croatian: Ispitivanja na životinjama nisu pokazala teratogene učinke tobramicina (vidjeti dio 5.3).
English: Based upon in-vitro data and/or clinical trial experience, the organisms associated with pulmonary infections in CF may be expected to respond to Vantobra therapy as follows:
Croatian: Na temelju in vitro podataka i/ili iskustava iz kliničkih ispitivanja, za organizme vezane za plućne infekcije kod CF može se očekivati sljedeći odgovor na terapiju lijekom Vantobra:
English: There are insufficient data in this population to support a recommendation for or against dose adjustment.
Croatian: Nema dovoljno podataka za ovu populaciju koji bi opravdali preporuku za ili protiv prilagodbe doze.
English: The recommended dose is one ampoule (170 mg/1.7 ml) administered twice daily (i.e. total daily dose is 2 ampoules) for 28 days.
Croatian: Preporučena doza je jedna ampula (170 mg/1,7 ml) primijenjena dva puta na dan (tj. ukupna dnevna doza iznosi 2 ampule) tijekom 28 dana.
English: • coughing up blood, producing more sputum than normally, chest discomfort, asthma, fever
Croatian: • iskašljavanje krvi, nakupljanje više ispljuvka nego obično, nelagoda u prsnom košu, astma, vrućica
English: Treatment should be continued on a cyclical basis for as long as the physician considers the patient is gaining clinical benefit from the treatment taking into account that long-term safety data are not available for Vantobra.
Croatian: Liječenje treba nastaviti ciklički dokle god liječnik smatra da bolesnik ima kliničke koristi od liječenja, imajući u vidu da za lijek Vantobra nisu dostupni dugoročni sigurnosni podaci.
English: The performance parameters from in vitro aerosol characterisation studies are identical for the two controllers and are shown in section 5.1, Table 2.
Croatian: Parametri funkcionalnosti iz in vitro ispitivanja svojstava aerosola jednaki su za oba regulatora te su navedeni u dijelu 5.1, Tablica 2.
English: If you have questions about how long to use Vantobra, talk to your doctor or pharmacist.
Croatian: Ako imate pitanja o tome koliko dugo uzimati lijek Vantobra, obratite se svom liječniku ili ljekarniku.
English: No effect on male or female fertility was observed in animal studies after subcutaneous administration (see section 5.3).
Croatian: Nije uočen nikakav učinak na plodnost mužjaka ili ženki u ispitivanjima na životinjama nakon supkutane primjene (vidjeti dio 5.3).
English: Bronchospasm should be treated as medically appropriate.
Croatian: Bronhospazam se mora liječiti na medicinski primjeren način.
English: Other medicines and Vantobra
Croatian: Drugi lijekovi i Vantobra
English: Symptoms of aerosol overdose may include severe hoarseness.
Croatian: Simptomi predoziranja aerosolom mogu uključivati tešku promuklost.
English: • The Tolero nebuliser handset must be cleaned and disinfected as described in the instructions for use of the device.
Croatian: • Ručni nebulizator Tolero mora se očistiti i dezinficirati kako je opisano u uputama za uporabu uređaja.
English: • If you need to interrupt your treatment for any reason, press and hold the On/Off button for one full second.
Croatian: • Ako iz bilo kojeg razloga trebate prekinuti Vaše liječenje, pritisnite dugme
English: If you are taking several different treatments for cystic fibrosis, you should take them in the following order:
Croatian: Ako cističnu fibrozu liječite na nekoliko različitih načina potrebno je držati se sljedećeg redoslijeda:
English: • Remove one ampoule of Vantobra from the aluminium foil sachet just before inhalation.
Croatian: • Izvadite jednu ampulu lijeka Vantobra iz aluminijske vrećice neposredno prije inhaliranja.
English: Concurrent use of Vantobra with diuretic compounds (such as ethacrynic acid, furosemide, urea or mannitol) is not recommended.
Croatian: Ne preporučuje se istodobna primjena lijeka Vantobra s diuretičkim spojevima (kao što su etakrinatna kiselina, furosemid, urea ili manitol).
English: Tobramycin did not impair fertility in male or female rats at subcutaneous doses up to 100 mg/kg/day.
Croatian: Tobramicin nije oštetio plodnost mužjaka i ženki štakora prilikom supkutane primjene doza do 100 mg/kg/dan.
English: • Risk Management Plan (RMP) The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: The amount of tobramycin excreted in human breast milk after administration by inhalation is not known, though it is estimated to be very low considering the low systemic exposure.
Croatian: Količina tobramicina koja se izlučuje u majčino mlijeko u ljudi nakon primjene inhalacijom nije poznata, iako se procjenjuje da je vrlo niska s obzirom na nisku sistemsku izloženost.
English: • allergic reactions including hives and itching (very rare, affecting up to 1 in 10,000 people).
Croatian: • alergijske reakcije uključujući koprivnjaču i svrbež (vrlo rijetko, javlja se u do 1 na 10 000 ljudi).
English: • blood in your sputum (the substance you cough up);
Croatian: • stezanje u prsnom košu; • krv u sputumu (sadržaj koji iskašljavate);
English: Vantobra has no or negligible influence on the ability to drive and use machines.
Croatian: Vantobra ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Vantobra should not be used during pregnancy unless the benefits to the mother outweigh the risks to the foetus or baby.
Croatian: Lijek Vantobra se ne smije koristiti tijekom trudnoće osim kada koristi za majku premašuju rizike za plod ili dijete.
English: If you use more Vantobra than you should
Croatian: Ako primijenite više lijeka Vantobra nego što ste trebali
English: Aspergillus species were more frequently recovered from the sputum of treated patients; however, clinical sequelae such as Allergic Bronchopulmonary Aspergillosis (ABPA) were reported rarely and with similar frequency as in the control group.
Croatian: Vrste plijesni Aspergillus češće se nalaze u sputumu liječenih bolesnika, međutim klinički ishod poput alergijske bronhopulmonalne aspergiloze (ABPA) rijetko je zabilježen i sa sličnom učestalošću kao u kontrolnoj grupi.
English: Inhalation should be performed by applying a normal breathing pattern without interruption.
Croatian: Inhalacija se provodi normalnim disanjem, bez prekida.
English: • Inhale by mouth the full content of one ampoule in the morning, and one ampoule in the evening using the Tolero nebuliser handset.
Croatian: • Inhalirajte na usta ukupni sadržaj jedne ampule ujutro i jedne ampule navečer koristeći ručni nebulizator Tolero.
English: • Read the Instructions for Use provided with the handset device before use.
Croatian: • Prije uporabe pročitajte upute za uporabu priložene uz ručni uređaj.
English: Vantobra contains an antibiotic medicine called tobramycin.
Croatian: Vantobra sadrži antibiotski lijek nazvan tobramicin.
English: Serum concentrations greater than 12 µg/ml are associated with tobramycin toxicity and treatment should be discontinued if concentrations exceed this level.
Croatian: Koncentracije u serumu veće od 12 μg/ml povezane su s toksičnošću tobramicina pa je liječenje potrebno prekinuti ako koncentracija prijeđe tu razinu.
English: Patients receiving concomitant parenteral aminoglycoside therapy (or any medicine affecting renal excretion, such as diuretics) should be monitored as clinically appropriate taking into account the risk of cumulative toxicity.
Croatian: Bolesnici koji istodobno parenteralno primaju aminoglikozid (ili bilo koji lijek koji utječe na bubrežno izlučivanje, kao što su diuretici) moraju se odgovarajuće klinički pratiti uzimajući u obzir rizik od kumulativne toksičnosti.
English: If an allergic response is suspected, Vantobra should be discontinued.
Croatian: Ako postoji sumnja na alergijsku reakciju, uzimanje lijeka Vantobra mora se prekinuti.
English: In repeated dose toxicity studies it has been shown that target organs of toxicity are the kidneys and vestibular/cochlear functions.
Croatian: U ispitivanjima toksičnosti ponovljenih doza pokazalo se da su ciljni organi toksičnosti bubrezi i vestibularna/kohlearna funkcija.
English: platinum compounds (risk of increased nephrotoxicity and ototoxicity);
Croatian: - lijekovi koji sadržavaju platinu (rizik od povećane nefrotoksičnosti i ototoksičnosti);
English: The development of antibiotic-resistant P. aeruginosa and superinfection with other pathogens represent potential risks associated with antibiotic therapy.
Croatian: Razvoj bakterije P. aeruginosa rezistentne na antibiotike te superinfekcija drugim patogenima predstavljaju potencijalne rizike povezane s antibiotskom terapijom.
English: Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može izazvati nuspojave iako se one neće javiti kod svakoga.
English: Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution.
Croatian: Tinitus može biti simptom koji upozorava na ototoksičnost te stoga pojava ovog simptoma zahtijeva oprez.
English: It is bactericidal at concentrations equal to or slightly greater than inhibitory concentrations.
Croatian: Tobramicin djeluje baktericidno u koncentracijama jednakim ili malo većim od inhibicijskih koncentracija.
English: In clinical studies patients using inhaled tobramycin continued to take dornase alfa, bronchodilators, inhaled corticosteroids and macrolides.
Croatian: U kliničkim ispitivanjima, bolesnici koji su inhalirali tobramicin nastavili su s uzimanjem dornaze alfa, bronhodilatatora, inhalacijskih kortikosteroida i makrolida.
English: Tobramycin is not metabolised and is primarily excreted unchanged in the urine.
Croatian: Tobramicin se ne metabolizira i prvenstveno se izlučuje nepromijenjen u mokraću.
English: Vantobra should be used with great caution in patients with neuromuscular disorders such as Parkinsonism or other conditions characterized by myasthenia, including myasthenia gravis, as aminoglycosides may aggravate muscle weakness due to a potential curare-like effect on neuromuscular function.
Croatian: Lijek Vantobra mora se primjenjivati s velikim oprezom u bolesnika s neuromuskularnim poremećajima, kao što je parkinsonizam ili druga stanja praćena mijastenijom, uključujući mijasteniju gravis, jer aminoglikozidi mogu pogoršati mišićnu slabost zbog potencijalnog učinka na neuromuskularnu funkciju poput onog što ga izaziva kurare.
English: There are limited data from the parenteral use of tobramycin in pregnant women.
Croatian: Postoje ograničeni podaci o parentalnoj uporabi tobramicina u trudnica.
English: Continue using Vantobra on this cyclical basis for as long as your doctor tells you.
Croatian: Nastavite primjenjivati lijek Vantobra u ovakvim ciklusima onoliko dugo koliko odredi Vaš liječnik.
English: Pseudomonas aeruginosa is a bacterium that frequently infects the lungs of cystic fibrosis patients at some time during their lives.
Croatian: Pseudomonas aeruginosa je bakterija koja često zarazi pluća oboljelih od cistične fibroze tijekom njihova života.
English: Preparing Vantobra for inhalation
Croatian: Priprema lijeka Vantobra za inhaliranje
English: Your doctor may ask you to use other appropriate medicines to widen the airways before using Vantobra.
Croatian: Vaš liječnik može Vam dati druge odgovarajuće lijekove koji će proširiti dišne putove prije nego što upotrijebite lijek Vantobra.
English: Treatment with the 28-days on and 28-days off dose regimen in clinical studies showed a small but clear increase in tobramycin, amikacin and gentamicin MICs for P. aeruginosa isolates tested.
Croatian: Klinička ispitivanja režima liječenja koji se sastojao od 28 dana uzimanja i 28 dana neuzimanja lijeka pokazala su malo ali jasno povećanje MIK vrijednosti tobramicina, amikacina i gentamicina za testirane izolate P. aeruginosa.
English: In case of a missed dose with at least 6 hours remaining until the next dose, the patient should inhale the dose as soon as possible.
Croatian: U slučaju propuštene doze pri čemu je do sljedeće doze ostalo najmanje 6 sati, bolesnik mora inhalirati dozu čim bude moguće.
English: Assessment of tobramycin serum concentrations may be helpful in monitoring overdose.
Croatian: Određivanje serumskih koncentracija tobramicina može biti od pomoći u praćenju predoziranja.
English: Subcutaneous administration at doses of 100 mg/kg/day in rats and the maximum tolerated dose of 20 mg/kg/day in rabbits during organogenesis was not teratogenic.
Croatian: Međutim, supkutana primjena doze od 100 mg/kg/dan u štakora te najviša podnošljiva doza od 20 mg/kg/dan u kunića tijekom organogeneze nije bila teratogena.
English: In general, toxicity is seen at higher systemic tobramycin levels than are achievable by inhalation of the recommended clinical dose.
Croatian: Toksičnost se općenito opaža pri sistemskim razinama tobramicina višim od onih koje se postižu inhalacijom u preporučenoj kliničkoj dozi.
English: • Make sure you have an eFlowrapid or eBase controller to connect the Tolero nebuliser handset.
Croatian: • Pobrinite se da imate regulator eFlow rapid ili eBase na koji ćete priključiti ručni nebulizator Tolero.
English: The Tolero nebuliser handset can be operated either with an eBase controller or with the eFlow rapid control unit.
Croatian: Ručni nebulizator Tolero možete koristiti s regulatorom eBase ili kontrolnom jedinicom eFlow rapid.
English: • anticholinesterases such as neostigmine and pyridostigmine (used to treat muscle weakness), or botulinum toxin.
Croatian: • antikolinesteraze poput neostigmina i piridostigmina (za liječenje slabosti mišića) ili botulinum toksin.
English: As it is preservative-free, the contents of the whole ampoule should be used immediately after opening and any unused solution should be discarded.
Croatian: Budući da ne sadrži konzervanse, sadržaj ampule je potrebno iskoristiti odmah nakon otvaranja, a svu neiskorištenu otopinu treba baciti.
English: Based on the interaction profile for tobramycin following intravenous and aerosolised administration, concurrent and/or sequential use of Vantobra is not recommended with other medicinal products with nephrotoxic or ototoxic potential, such as:
Croatian: Na temelju profila interakcija za tobramicin nakon intravenske primjene i primjene aerosolom, ne preporučuje se istodobna i/ili sekvencijska primjena lijeka Vantobra s drugim lijekovima koji mogu imati nefrotoksične ili ototoksične učinke, kao što su:
English: CFU reduction as an indicator for suppression of P. aeruginosa was comparable for Vantobra and the reference product.
Croatian: Smanjenje CFU-a kao pokazatelj supresije P. aeruginosa je usporedivo za lijek Vantobra i referentni lijek.
English: There are no data in this population to support a recommendation for or against dose adjustment with Vantobra.
Croatian: Nema podataka za ovu populaciju koji bi opravdali preporuku za ili protiv prilagodbe doze lijeka Vantobra.
English: Because of the potential for ototoxicity and nephrotoxicity in infants, a decision should be made whether to terminate breast-feeding or discontinue treatment with Vantobra, taking into account the importance of the treatment to the mother.
Croatian: Zbog mogućeg rizika od ototoksičnosti i nefrotoksičnosti u dojenčadi, mora se odlučiti hoće li se prekinuti dojenje ili liječenje lijekom Vantobra, imajući pritom u vidu važnost liječenja za majku.
English: • chest tightness with difficulty in breathing (rare, affecting up to 1 in 1,000 people)
Croatian: • stezanje u prsnom košu s poteškoćama u disanju (rijetko, javlja se u do 1 na 1000 ljudi)
English: Following intravenous administration, systemically absorbed tobramycin is eliminated by glomerular filtration.
Croatian: Nakon primjene intravenskim putem, sistemski se apsorbirani tobramicin izlučuje glomerularnom filtracijom.
English: There was no evidence of nephrotoxicity during clinical trials with inhaled tobramycin and Vantobra.
Croatian: Nije bilo dokaza nefrotoksičnosti tijekom kliničkih ispitivanja inhaliranog tobramicina i lijeka Vantobra.
English: Teratogenicity could not be assessed at higher parenteral doses in rabbits as they induced maternal toxicity and abortion.
Croatian: Teratogenost parenteralno primijenjenih visokih doza u kunića nije se mogla procijeniti jer su dovodile do maternalne toksičnosti i pobačaja.
English: It is supplied in a box that contains two inner boxes, one with the medicine (56 ampoules with nebuliser solution in 7 sachets), and one with the nebuliser handset.
Croatian: Isporučuje se u kutiji koja sadrži dvije unutarnje kutije, jednu s lijekom (56 ampula s otopinom za nebulizator u 7 vrećica) i jednu s ručnim nebulizatorom.
English: Vantobra must not be administered by any other route or using any other device than the one provided in the pack.
Croatian: Lijek Vantobra ne smije se primjenjivati niti jednim drugim putem ili korištenjem bilo kojeg drugog uređaja osim onog koji je isporučen u pakiranju.
English: Strains of Pseudomonas can become resistant to treatment with an antibiotic over time.
Croatian: Pseudomonas tijekom vremena mogu postati otporni na liječenje antibioticima.