FrancophonIA/ELRC3.0 huggingface dataset:
English: Side effects reported with Quofenix are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Quofenix pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The European Medicines Agency decided that Quofenix's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Quofenix nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Quofenix have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Quofenix nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Fluoroquinolones work by preventing bacteria involved in skin infections from making copies of their DNA (genetic material).
Croatian: Fluorokinoloni djeluju tako što sprječavaju bakterije koje uzrokuju infekciju da stvaraju kopije svojeg DNK-a (genetskog materijala).
English: Quofenix can only be obtained with a prescription and prescribers should take into account official guidance on the use of antibiotics.
Croatian: Quofenix se izdaje samo na recept, a liječnici koji propisuju lijek trebaju uzeti u obzir službene smjernice o primjerenoj upotrebi antibiotika.
English: The active substance in Quofenix, delafloxacin, belongs to a group of antibiotics called fluoroquinolones.
Croatian: Djelatna tvar u lijeku Quofenix, delafloksacin, pripada skupini antibiotika naziva fluorokinoloni.
English: What is Quofenix and what is it used for?
Croatian: Što je Quofenix i za što se koristi?
English: Other information about Quofenix
Croatian: Ostale informacije o lijeku Quofenix
English: As for all medicines, data on the use of Quofenix are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Quofenix kontinuirano se prate.
English: For more information about using Quofenix, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Quofenix pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: Quofenix was shown to be as effective as alternative antibiotics in two main studies of adults with acute bacterial skin and skin structure infections.
Croatian: Lijek Quofenix pokazao se jednako učinkovitim kao alternativni antibiotici u dvama glavnim ispitivanjima u odraslih bolesnika s akutnim bakterijskim infekcijama kože i kožnih struktura.
English: Quofenix must not be used in patients who are hypersensitive (allergic) to quinolone or fluoroquinolone antibiotics or in patients who have had tendon disorders related to treatment with a fluoroquinolone antibiotic.
Croatian: Quofenix se ne smije primjenjivati u bolesnika koji su preosjetljivi (alergični) na antibiotike kinolone ili fluorokinolone ili u bolesnika koji su imali poremećaje tetiva povezane s primjenom antibiotika fluorokinolona.
English: Quofenix is an antibiotic used in adults to treat bacterial infections of the skin and underlying tissues (acute bacterial skin and skin structure infections) when other medicines are not suitable.
Croatian: Quofenix je antiobiotik koji se u odraslih osoba koristi za liječenje bakterijskih infekcija kože i potkožnih tkiva (akutnih bakterijskih infekcija kože i kožnih struktura) kad se upotreba drugih lijekova smatra neprikladnom.
English: Why is Quofenix authorised in the EU?
Croatian: Zašto je lijek Quofenix odobren u EU-u?
English: An overview of Quofenix and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Quofenix i zašto je odobren u EU-u
English: The most common side effects with Quofenix (which may affect up to 1 in 10 people) are diarrhoea and nausea (feeling sick), which are mild to moderate.
Croatian: Najčešće nuspojave lijeka Quofenix (koje se mogu javiti u do 1 na 10 osoba) jesu proljev i mučnina te su blage do umjerene.
English: It contains the active substance delafloxacin.
Croatian: Sadrži djelatnu tvar delafloksacin.
English: What are the risks associated with Quofenix?
Croatian: Koji su rizici povezani s lijekom Quofenix?
English: After treatment for up to 14 days, 58% of patients who received Quofenix were cured of their infection compared with 60% of patients who received vancomycin and aztreonam.
Croatian: Nakon najviše 14 dana terapije 58 % bolesnika koji su primali lijek Quofenix bili su izliječeni od infekcije u usporedbi sa 60 % bolesnika koji su primali vankomicin i aztreonam.
English: Quofenix is as effective as alternative antibiotics given into a vein in treating acute bacterial skin and skin structure infections and offers the possibility of switching to treatment by mouth, which may be more convenient for the patient and could reduce hospitalisation costs.
Croatian: Lijek Quofenix jednako je učinkovit kod liječenja akutnih bakterijskih infekcija kože i kožnih struktura kao i alternativni antibiotici koji se daju u obliku infuzije te za njega postoji mogućnost prelaska na peroralnu primjenu, što može biti praktičnije za bolesnika i može smanjiti troškove hospitalizacije.
English: How does Quofenix work?
Croatian: Kako djeluje Quofenix?
English: In the first study involving 660 patients, Quofenix given into a vein was compared with vancomycin plus aztreonam (two other antibiotics) both given into a vein.
Croatian: U prvom ispitivanju koje je obuhvaćalo 660 bolesnika lijek Quofenix primijenjen u obliku infuzije uspoređivan je s vankomicinom i aztreonamom (druga dva antibiotika) primijenjenima u obliku
English: In the second study involving 850 patients, Quofenix given into a vein for 3 days and afterwards given as tablets by mouth was compared with vancomycin plus aztreonam given into a vein.
Croatian: U drugom ispitivanju koje je obuhvaćalo 850 bolesnika lijek Quofenix, koji je primjenjivan prva tri dana u obliku infuzije i nakon toga peroralno u obliku tableta, uspoređivan je s vankomicinom i aztreonamom koji su primjenjivani u obliku infuzije.
English: For the full list of side effects and restrictions with Quofenix, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja povezanih s primjenom lijeka Quofenix potražite u uputi o lijeku.
English: What benefits of Quofenix have been shown in studies?
Croatian: Koje su koristi od lijeka Quofenix utvrđene u ispitivanjima?
English: Persistent and disabling side effects have occurred with fluoroquinolone antibiotics in some patients.
Croatian: Neki od bolesnika koji su uzimali antibiotike fluorokinolone imali su trajne i onesposobljavajuće nuspojave.
English: patients treated with Quofenix were cured of their infection, compared with 51% of patients treated with vancomycin and aztreonam.
Croatian: Nakon najviše 14 dana terapije 52 % bolesnika koji su primali lijek Quofenix izliječeni su od infekcije u usporedbi s 51 % bolesnika koji su liječeni vankomicinom i aztreonamom.
English: This overview was last updated in September 2019.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u rujnu 2019.
English: Virulent means that the virus is capable of producing severe disease.
Croatian: Virulentan znači da virus može prouzročiti tešku bolest.
English: Further information on Gumbohatch can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/gumbohatch.
Croatian: Više informacija o cjepivu Gumbohatch dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/veterinary/EPAR/gumbohatch.
English: Studies have shown the start of protection to be from between 24 days of age and 28 days of age.
Croatian: Ispitivanja su pokazala da zaštita počinje u razdoblju između 24. i 28. dana starosti.
English: Gumbohatch was investigated in 5 laboratory and 3 field studies.
Croatian: Cjepivo Gumbohatch ispitivano je u pet laboratorijskih i tri terenska ispitivanja.
English: Protection against IBD starts from between 24 to 28 days of age and lasts up to 43 days of age.
Croatian: Zaštita od zarazne bolesti burze započinje između 24. i 28. dana starosti i traje do 43. dana starosti.
English: This loss of lymphocytes does not cause immunosuppression in the chickens.
Croatian: Gubitak limfocita ne uzrokuje imunosupresiju kod pilića.
English: The start of protection depends on the initial maternal antibody level of the batch of chickens and even then will be different for individual chickens.
Croatian: Početak zaštite ovisi o početnoj razini majčinskih protutijela u određenoj seriji pilića, a čak i tada će biti odstupanja među pojedinim pilićima.
English: What is the withdrawal period in food-producing animals?
Croatian: Koje je razdoblje karencije u životinja koje se koriste za proizvodnju hrane?
English: The vaccine can be given to one-day-old chicks as a single injection under the skin or directly into 18day-old chicken eggs containing embryos (unhatched developing chicks).
Croatian: Cjepivo se može dati pilićima starima jedan dan kao jednokratna injekcija pod kožu ili izravno u jaja stara 18 dana koja sadržavaju zametke (neizvaljene piliće u razvoju).
English: After handling vaccinated birds or their litter, hands should be washed and disinfected because the virus is excreted by vaccinated birds for up to 3 weeks.
Croatian: Nakon rukovanja cijepljenim pticama ili njihovim leglom treba oprati i dezinficirati ruke jer cijepljene ptice izlučuju virus u razdoblju do tri tjedna.
English: The withdrawal period for meat and eggs from chickens treated with Gumbohatch is ‘zero' days, which means that there is no mandatory waiting time.
Croatian: Razdoblje karencije za meso i jaja pilića liječenih cjepivom Gumbohatch iznosi „nula” dana, odnosno nema obveznog razdoblja čekanja.
English: Vaccines work by preparing the immune system (the body's natural defences) to defend itself against a specific disease.
Croatian: Cjepiva djeluju tako što pripremaju imunosni sustav (prirodnu obranu tijela) na obranu od određene bolesti.
English: Gumbohatch is a vaccine.
Croatian: Gumbohatch je cjepivo.
English: When the chicken comes into contact with a similar IBD virus, these antibodies, together with other components of the chicken's immune system, will be able to fight the infection and help protect it against the disease.
Croatian: Kada pilić dođe u kontakt sa sličnim virusom zarazne bolesti burze, ta će se protutijela, zajedno s drugim sastavnicama imunosnog sustava pilića, moći boriti protiv infekcije i pomoći u zaštiti od bolesti.
English: Other information about Gumbohatch
Croatian: Ostale informacije o VMP-u Gumbohatch
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Croatian: U slučaju slučajnog samoinjektiranja potrebno je odmah potražiti liječnički savjet te mu pokazati uputu o VMP-u ili njegovu etiketu.
English: Why is Gumbohatch authorised in the EU?
Croatian: Zašto je Gumbohatch odobren u EU-u?
English: What is Gumbohatch and what is it used for?
Croatian: Što je Gumbohatch i za što se koristi?
English: When a chick or chicken egg is given the vaccine, the immune system recognises the weakened virus in the vaccine as ‘foreign' and makes its own antibodies against the virus.
Croatian: Kada pilić ili kokošje jaje prime cjepivo, imunosni sustav prepoznaje oslabljeni virus u cjepivu kao „strano tijelo” i protiv njega proizvodi vlastita protutijela.
English: The vaccine reduces signs of the disease and damage to the bursa of Fabricius, an organ only present in birds which is part of their immune system.
Croatian: Cjepivo ublažava simptome bolesti i oštećenje Fabricijeve burze, organa koji imaju samo ptice i koji je sastavni dio njihovog imunosnog sustava.
English: Signs of chickens infected with Gumboro disease include trembling, ruffled feathers, poor appetite, dehydration, diarrhoea, huddling and depression.
Croatian: U simptome zaraze gumborskom bolešću spadaju drhtanje, razbarušeno perje, smanjen apetit, dehidracija, proljev, pripijanje pilića jednih uz druge i depresija.
English: IBD, also known as Gumboro disease, is a highly contagious (spreads easily) viral infection of young chickens that reduces their immunity (body's ability to fight disease) and can lead to their death at 3 to 6 weeks of age.
Croatian: Zarazna bolest burze, poznata i kao gumborska bolest, iznimno je zarazna (lako se širi) virusna infekcija mladih pilića koja oslabljuje njihov imunitet (sposobnost tijela da se brani od bolesti) i može prouzročiti smrt u dobi od tri do šest tjedana.
English: The European Medicines Agency decided that Gumbohatch's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od cjepiva Gumbohatch nadmašuju s njim povezane rizike te da cjepivo može biti odobreno za primjenu u EU-u.
English: Hands and equipment should be washed and disinfected after use of the vaccine.
Croatian: Nakon primjene cjepiva potrebno je oprati i dezinficirati ruke i opremu.
English: For more information about using Gumbohatch, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Za dodatne informacije o primjeni cjepiva Gumbohatch pogledajte uputu o VMP-u, odnosno obratite se svom veterinaru ili ljekarniku.
English: What are the risks associated with Gumbohatch?
Croatian: Koji su rizici povezani s VMP-om Gumbohatch?
English: The studies showed Gumbohatch to reduce clinical signs and damage to the bursa of Fabricius caused by very virulent (powerful) IBD virus infection, following vaccination of eggs or chicks.
Croatian: Ispitivanja su pokazala da cjepivo Gumbohatch smanjuje kliničke znakove i oštećenje Fabricijeve burze, koju uzrokuje vrlo virulentna (snažna) infekcija virusom zarazne bolesti burze, nakon cijepljenja jaja ili pilića.
English: An overview of Gumbohatch and why it is authorised in the EU
Croatian: Pregled informacija o VMP-u Gumbohatch i zašto je odobren u EU-u
English: Gumbohatch is a vaccine used to protect broiler chickens (reared for meat) against infectious bursal disease (IBD) virus infection caused by a very virulent IBD virus.
Croatian: Gumbohatch je cjepivo koje se koristi za zaštitu pilića-brojlera (koji se uzgajaju za proizvodnju mesa) od infekcije virusom zarazne bolesti burze (IBD), koju uzrokuje vrlo virulentan virus zarazne bolesti burze.
English: Gumbohatch contains a live strain of IBD virus (strain 1052) that has been weakened so that it does not cause the disease.
Croatian: Cjepivo Gumbohatch sadrži soj živog virusa zarazne bolesti burze (soj 1052), koji je oslabljen kako ne bi uzrokovao bolest.
English: The vaccine should be used only in flocks that are known to have maternal antibodies (transmitted from the mother) against IBD virus.
Croatian: Cjepivo se treba koristiti samo u jatima za koja je utvrđeno da imaju majčinska protutijela (koja im prenosi majka) protiv virusa zarazne bolesti burze.
English: It is also the time required after administration of a medicine before eggs may be used for human consumption.
Croatian: To je također vrijeme koje treba proći nakon primjene VMP-a prije nego što ljudi smiju konzumirati jaja dotične životinje.
English: For the full list of restrictions, see the package leaflet.
Croatian: Potpuni popis ograničenja povezanih s primjenom potražite u uputi o VMP-u.
English: The laboratory studies involved chicks with maternal antibodies against IBD virus.
Croatian: Laboratorijska su ispitivanja uključivala piliće s majčinskim protutijelima protiv virusa zarazne bolesti burze.
English: Gumbohatch contains small amounts of weakened IBD virus attached to antibodies.
Croatian: Gumbohatch sadrži male količine oslabljenog virusa zarazne bolesti burze koje su spojene na protutijela.
English: Gumbohatch must not be used in flocks without maternal antibodies against IBD virus.
Croatian: Gumbohatch se ne smije primjenjivati u jatima koja nemaju majčinskih protutijela protiv virusa zarazne bolesti burze.
English: Gumbohatch is available as a freeze dried powder (lyophilisate) and solvent to be made into a suspension for injection and can only be obtained with a prescription.
Croatian: Cjepivo Gumbohatch dostupno je u obliku smrznutog osušenog praha (liofilizata) i u obliku otapala za pripremu suspenzije za injekciju, a izdaje se samo na veterinarski recept.
English: The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption.
Croatian: Razdoblje karencije je vrijeme koje treba proći od primjene VMP-a do klanja životinje i korištenja mesa za prehranu ljudi.
English: How is Gumbohatch used?
Croatian: Kako se Gumbohatch koristi?
English: The most common side effect with Gumbohatch (which may affect more than 1 in 10 animals) is a fall in the number of lymphocytes (a type of white blood cell which is part of the chicken's immune system) in the bursa of Fabricius, followed by an increase and recovery of the bursa of Fabricius.
Croatian: Najčešće nuspojave cjepiva Gumbohatch (mogu se javiti u više od 1 na 10 životinja) jesu pad broja limfocita (vrste bijelih krvnih stanica koje su sastavni dio imunosnog sustava pilića)
English: How does Gumbohatch work?
Croatian: Kako djeluje Gumbohatch?
English: What benefits of Gumbohatch have been shown in studies?
Croatian: Koje su koristi od VMP-a Gumbohatch utvrđene u ispitivanjima?
English: Gumbohatch received a marketing authorisation valid throughout the EU on 12 November 2019.
Croatian: Za cjepivo Gumbohatch izdano je odobrenje za stavljanje u promet koje je na snazi u EU-u od
English: MA (EU) number
Croatian: Broj (EU) odobrenja (Zaštićeno) ime
English: Your body can also make too much sugar.
Croatian: Vaše tijelo može također proizvoditi previše šećera.
English: Do not take a double dose of this medicine.
Croatian: Nemojte uzeti dvostruku dozu ovog lijeka.
English: The potential risk for humans is unknown.
Croatian: Nije poznat potencijalni rizik za ljude.
English: A double dose should not be taken on the same day.
Croatian: Ne smije se uzeti dvostruka doza istoga dana.
English: Based on a Cox model stratified by region.
Croatian: Na temelju Coxova modela stratificiranog prema regijama.
English: Poznańska 12 05-850 Ożarów Mazowiecki Poland
Croatian: Poznańska 12 05-850 Ożarów Mazowiecki Poljska
English: You can take this medicine with or without food and drink.
Croatian: Ovaj lijek možete uzimati sa ili bez hrane i pića.
English: Children and adolescents below 18 years should not use this medicine.
Croatian: Djeca i adolescenti mlađi od 18 godina ne smiju uzimati ovaj lijek.
English: What Ristaben is and what it is used for
Croatian: Što je Ristaben i za što se koristi
English: You should not take this medicine during pregnancy.
Croatian: Ne smijete uzimati ovaj lijek tijekom trudnoće.
English: Opaque blisters (PVC/PE/PVDC and aluminum).
Croatian: Neprozirni blisteri (PVC/PE/PVDC i aluminij).
English: In particular, tell your doctor if you are taking digoxin (a medicine used to treat irregular heart beat and other heart problems).
Croatian: Naročito, recite Vašem liječniku ukoliko uzimate digoksin (lijek koji se koristi za liječenje nepravilnog srčanog ritma i drugih problema sa srcem).
English: Diet and exercise can help your body use its blood sugar better.
Croatian: Dijeta i tjelovježba mogu pomoći da tijelo bolje iskoristi šećer u krvi.
English: Secondary Outcome
Croatian: Sekundarni ishod
English: Onset of these reactions occurred within the first 3 months after initiation of treatment, with some reports occurring after the first dose.
Croatian: Ove su reakcije nastupile unutar prva 3 mjeseca nakon početka liječenja, a u nekim slučajevima prijavljene su već nakon prve doze.
English: STOP taking Ristaben and contact a doctor immediately if you notice any of the following serious side effects:
Croatian: PRESTANITE uzimati Ristaben i odmah se javite liječniku ako primijetite bilo koju od sljedećih ozbiljnih nuspojava:
English: Rare: reduced number of platelets
Croatian: Rijetko: smanjen broj krvnih pločica
English: There was no difference in the incidence of severe hypoglycaemia.
Croatian: Nije bilo razlike u incidenciji teške hipoglikemije.
English: It is not known if this medicine is safe and effective when used in children and adolescents under 18 years of age.
Croatian: Nije poznato je li ovaj lijek siguran i djelotvoran kada ga uzimaju djeca i adolescenti mlađi od 18 godina.
English: When this happens, sugar (glucose) builds up in the blood.
Croatian: Kad se to dogodi, šećer (glukoza) se nakuplja u krvi.
English: Do not throw away medicines via wastewater or household waste.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: The relevance of these findings for humans is unknown.
Croatian: Nije poznat značaj ovih nalaza za ljude.
English: Date of first authorisation: 15 March 2010 Date of latest renewal: 16 December 2014
Croatian: Datum posljednje obnove odobrenja: 16. prosinca 2014.
English: What is type 2 diabetes?
Croatian: Što je šećerna bolest tipa 2?
English: Uncommon: dry mouth
Croatian: Manje često: suha usta
English: Do not take Ristaben - if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati lijek Ristaben - ako ste alergični na sitagliptin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Common: flu
Croatian: Često: gripa
English: Studies in animals have shown reproductive toxicity at high doses (see section 5.3).
Croatian: Istraživanja na životinjama pokazala su reproduktivnu toksičnost pri visokim dozama (vidjeti dio 5.3).
English: Common: swelling of the hands or legs
Croatian: Često: oticanje ruku ili nogu
English: What Ristaben looks like and contents of the pack
Croatian: Kako Ristaben izgleda i sadržaj pakiranja
English: Frequencies are defined as: 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).
Croatian: Učestalosti su definirane kao: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule.
Croatian: Ako se ne sjetite dok nije vrijeme za sljedeću dozu, preskočite propuštenu dozu i nastavite s uobičajenim rasporedom.
English: 2031 BN Haarlem The Netherlands
Croatian: 2031 BN Haarlem Nizozemska
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: You should not stop taking this medicine without talking to your doctor first.
Croatian: Ne smijete prestati uzimati ovaj lijek ako prethodno niste o tome razgovarali s liječnikom.
English: This medicine helps to increase the levels of insulin produced after a meal and decreases the amount of sugar made by the body.
Croatian: Ovaj lijek pomaže povisiti razine inzulina koje se proizvedu nakon obroka i smanjuje količinu šećera kojeg tijelo proizvodi.
English: Elderly subjects (65 to 80 years) had approximately 19 % higher plasma concentrations of sitagliptin compared to younger subjects.
Croatian: Stariji ispitanici (65 do 80 godina) imali su približno 19% više koncentracije sitagliptina u plazmi u odnosu na mlađe ispitanike.
English: No dose adjustment of digoxin is recommended.
Croatian: Ne preporučuje se prilagodba doze digoksina.