FrancophonIA/ELRC3.0 huggingface dataset:
English: It will also maintain a registry of patients inadvertently treated with Vibativ during pregnancy, to monitor the subsequent effect on development of children from birth to 12 months of age.
Croatian: Ona će također voditi registar bolesnica koje su nehotično liječeni lijekom Vibativ tijekom trudnoće radi nadzora kasnijeg učinka na razvoj djece od rođenja do 12 mjeseci starosti.
English: This includes pneumonia caused by the use of a ventilator (a machine used in hospitals that helps patients to breathe).
Croatian: To uključuje upalu pluća uzrokovanu primjenom ventilatora (uređaja koji se upotrebljava u bolnicama, a koji bolesnicima olakšava disanje).
English: For obese patients, a lower dose of 7.5 mg per kg body weight once every 24 hours is recommended.
Croatian: Za pretile bolesnike preporučuje se manja doza od 7,5 mg po kilogramu tjelesne težine jedanput svaka 24 sata.
English: The company that markets Vibativ will ensure all doctors who are expected to prescribe or use Vibativ receive a letter and an educational pack containing the summary of product characteristics, package leaflet and a guide setting out important safety information on the correct use of Vibativ.
Croatian: Tvrtka koja lijek Vibativ stavlja u promet osigurat će da svi liječnici za koje se očekuje da će propisivati ili primjenjivati lijek Vibativ dobiju pismo i edukativni paket koji sadrži sažetak opisa svojstava lijeka, uputu o lijeku i upute s važnim sigurnosnim informacijama o ispravnoj primjeni lijeka Vibativ.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Vibativ.
English: In addition, care should be taken when giving Vibativ to patients taking other medicines that could cause kidney problems, those who already have kidney disease or have other diseases that make them more likely to have kidney problems, such as diabetes, congestive heart failure (a type of heart disease) and hypertension (high blood pressure).
Croatian: Osim toga, potrebno je obratiti pozornost prilikom davanja lijeka Vibativ bolesnicima koji uzimaju druge lijekove koji mogu uzrokovati probleme s bubrezima, onima koji već boluju od bolesti bubrega ili boluju od drugih bolesti koje mogu uzrokovati probleme s bubrezima, kao što su dijabetes, kongestivno zatajenje srca (vrsta srčane bolesti) i hipertenzija (visoki krvni tlak).
English: For more information about treatment with Vibativ, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Vibativ pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: What is the risk associated with Vibativ?
Croatian: Koji su rizici povezani s lijekom Vibativ?
English: It is available as a powder to be made up into a solution for infusion (drip) into a vein.
Croatian: Dostupan je kao prašak za pripremu otopine za infuziju (drip u venu).
English: It works by stopping the bacteria causing the infection from making their own cell walls and by disrupting their cell membranes, thereby killing the bacteria.
Croatian: Djeluje tako da onemogućuje bakterijama koje uzrokuju infekciju da proizvode vlastite stanične stijenke i probija njihove stanične membrane, čime ubija bakterije.
English: The most common side effects with Vibativ (seen in more than 1 patient in 10) are dysgeusia (taste disturbances) and nausea (feeling sick).
Croatian: Najčešće nuspojave lijeka Vibativ (uočene u više od 1 na 10 bolesnika) su poremećaj okusa (disgeuzija) i mučnina (osjećaj slabosti).
English: The active substance in Vibativ, telavancin, is an antibiotic that belongs to the group ‘glycopeptides'.
Croatian: Djelatna tvar u lijeku Vibativ, telavancin, jest antibiotik koji pripada skupini „glikopeptida”.
English: Vibativ was also compared with vancomycin in two main studies involving a total of 1,897 adults with complicated infections of the skin and soft tissue below the skin caused by Gram-positive bacteria, where the medicines were given for up to 14 days.
Croatian: Vibativ je također uspoređen s vankomicinom u dvama glavnim ispitivanjima koja su uključivala ukupno 1 897 odraslih osoba s kompliciranim infekcijama kože i mekog tkiva ispod kože uzrokovanima gram-pozitivnim bakterijama, pri čemu su lijekovi primjenjivani u razdoblju do najviše 14 dana.
English: Vibativ is a medicine that contains the active substance telavancin.
Croatian: Vibativ je lijek koji sadrži djelatnu tvar telavancin.
English: Vibativ must not be given to patients with severe kidney problems or acute (sudden) kidney failure.
Croatian: Lijek Vibativ ne smije se davati bolesnicima s ozbiljnim problemima s bubrezima ili akutnim (iznenadnim) zatajenjem bubrega.
English: Why has Vibativ been approved?
Croatian: Zašto je lijek Vibativ odobren?
English: It is effective against MRSA bacteria, which are resistant to other commonly used groups of antibiotics such as penicillins (including methicillin and oxacillin) and cephalosporins.
Croatian: Učinkovita je protiv bakterija MRSA koje su otporne na antibiotike koji se uobičajeno koriste, a koji su poznati kao penicilini (uključujući metilicin i oksalicin) i cefalosporini.
English: What measures are being taken to ensure the safe use of Vibativ?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vibativ?
English: The CHMP concluded that, although Vibativ had been shown to be effective in treating both nosocomial pneumonia and complicated infections of the skin and soft tissue, its toxic effect on the kidneys was an important safety concern.
Croatian: CHMP je zaključio da, iako se lijek Vibativ pokazao učinkovitim u liječenju bolničke upale pluća i kompliciranih infekcija kože i mekog tkiva, njegovi toksični utjecaji izazivaju značajnu zabrinutost u pogledu sigurnosti.
English: Vibativ is used only when the infection is known or believed to be caused by bacteria called ‘methicillin-resistant Staphylococcus aureus' (MRSA) and when other treatments (such as other antibiotics) are not suitable.
Croatian: Vibativ se koristi samo u onim slučajevima kada je utvrđeno ili se smatra da je infekciju uzrokovala bakterija meticilin-rezistentan Staphylococcus aureus (MRSA) i kada druge terapije (kao što su drugi antibiotici) nisu prikladne.
English: Vibativ was compared with vancomycin (another antibiotic) in two main studies involving a total of 1,503 adults with nosocomial pneumonia caused by Gram-positive bacteria (types of bacteria that include MRSA).
Croatian: Vibativ je uspoređen s vankomicinom (drugim antibiotikom) u dvama glavnim ispitivanjima koja su uključivala ukupno 1 503 odrasle osobe s bolničkom upalom pluća koju uzrokuju gram-pozitivne bakterije (vrste bakterija koje uključuju MRSA).
English: However, the Committee considered that Vibativ could be valuable for treating patients with nosocomial pneumonia known or believed to be caused by MRSA for whom other treatments are not suitable.
Croatian: Međutim, Odbor je smatrao da bi lijek Vibativ mogao biti koristan za liječenje bolesnika s bolničkom upalom pluća za koju je utvrđeno ili se smatra da ju je uzrokovala bakterija MRSA za koju druge terapije nisu prikladne.
English: Therefore, the CHMP decided that Vibativ's benefits are only greater than its risks for patients who are severely ill with nosocomial pneumonia and are under close observation in hospital, and recommended that it be given marketing authorisation.
Croatian: Stoga je CHMP odlučio da koristi od lijeka Vibativ nadmašuju s njim povezane rizike samo u slučaju bolesnika koji boluju od teške bolničke upale pluća i koji su pod strogim bolničkim nadzorom te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Vibativ was as effective as vancomycin at curing nosocomial pneumonia and complicated infections of the skin and soft tissue.
Croatian: Lijek Vibativ pokazao se jednako učinkovitim kao vankomicin u izlječenju bolničke upale pluća i kompliciranih infekcija kože te mekog tkiva.
English: Kidney function should be monitored and the initial and subsequent doses may have to be lowered for patients with minor kidney problems, while treatment may need to be stopped if kidney function gets markedly worse.
Croatian: Potrebno je pratiti funkciju rada bubrega te će kod bolesnika s manjim problemima s bubrezima možda biti potrebno smanjiti početne i naredne doze, dok će u slučaju znatnog pogoršanja funkcije bubrega možda biti potrebno prekinuti liječenje.
English: Studies showed that more patients developed kidney problems following treatment with Vibativ than with vancomycin (3.8% versus 2.2%).
Croatian: Ispitivanja su pokazala da je više bolesnika imalo problema s bubrezima nakon liječenja lijekom Vibativ nego nakon liječenja vankomicinom (3,8 % naspram 2,2 %).
English: What benefit has Vibativ shown during the studies?
Croatian: Koje su koristi lijeka Vibativ dokazane u ispitivanjima?
English: The company will carry out a study to assess side effects that are experienced by patients using Vibativ and another to monitor for the development of bacteria resistant to the medicine.
Croatian: Tvrtka će provesti ispitivanje radi procjene nuspojava koje se javljaju u bolesnika koji uzimaju lijek Vibativ te još jedno ispitivanje radi nadzora razvoja bakterija otpornih na lijek.
English: How does Vibativ work?
Croatian: Kako djeluje Vibativ?
English: The European Commission granted a marketing authorisation valid throughout the European Union
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Vibativ na snazi u Europskoj uniji od 2. rujna 2011.
English: For the full list of restrictions with Vibativ, see the package leaflet.
Croatian: Potpuni popis ograničenja za lijek Vibativ potražite u uputi o lijeku.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vibativ have also been included in the summary of product characteristics and the
Croatian: U sažetku opisa svojstava lijeka i uputi o lijeku također se nalaze preporuke i mjere opreza za sigurnu i učinkovitu primjenu lijeka Vibativ kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: In the first study in complicated infections of the skin and soft tissue, 76% of patients treated with Vibativ (323 out of 426) were cured after treatment compared with 75% treated with vancomycin (321 out of 429).
Croatian: U prvom ispitivanju na bolesnicima s kompliciranim infekcijama kože i mekog tkiva, nakon liječenja bilo je izliječeno 76 % bolesnika koji su primali lijek Vibativ (323 od 426) u usporedbi sa 75 % bolesnika koji su primali vankomicin (321 od 429).
English: In the second study, 77% of patients treated with Vibativ (387 out of 502) were cured after treatment compared with 74% of those treated with vancomycin (376 out of 510).
Croatian: U drugom ispitivanju, nakon liječenja bilo je izliječeno 77 % bolesnika koji su primali lijek Vibativ (387 od 502) u usporedbi sa 74 % bolesnika koji su primali vankomicin (376 od 510).
English: In the first study in nosocomial pneumonia, 58% of patients treated with Vibativ (214 out of 372) were cured after treatment compared with 59% of patients treated with vancomycin (221 out of 374).
Croatian: U prvom ispitivanju među bolesnicima s bolničkom upalom pluća, nakon liječenja bilo je izliječeno 58 % bolesnika koji su primali lijek Vibativ (214 od 372) u usporedbi s 59 % bolesnika koji su primali vankomicin (221 od 374).
English: Vibativ is used to treat adults with nosocomial pneumonia (an infection of the lungs).
Croatian: Vibativ je indiciran za liječenje odraslih osoba s bolničkom upalom pluća. „Bolnička” znači da je do infekcije došlo u bolnici.
English: For the full list of all side effects reported with Vibativ, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Vibativ potražite u uputi o lijeku.
English: How has Vibativ been studied?
Croatian: Kako se Vibativ koristi?
English: In the second study, 60% of patients treated with Vibativ (227 out of 377) were cured after treatment compared with 60% of patients treated with vancomycin (228 out of
Croatian: U drugom ispitivanju, nakon liječenja bilo je izliječeno 60 % bolesnika koji su primali lijek Vibativ (227 od 377) u usporedbi sa 60 % bolesnika koji su primali vankomicin (228 od 380).
English: Treatment can be repeated once a month.
Croatian: Tretiranje se može ponoviti jednom mjesečno.
English: These usually disappear within 24 hours after administration.
Croatian: Te nuspojave obično nestaju u roku od 24 sata nakon primjene.
English: Treated dogs should not be permitted to sleep with their owners, especially children, on the day of treatment.
Croatian: Tretiranim psima ne smije se dopustiti da na dan liječenja spavaju sa svojim vlasnicima, a posebno s djecom.
English: Further information on Vectra 3D can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/vectra-3d.
Croatian: Više informacija o VMP-u Vectra 3D nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/veterinary/EPAR/vectra-3d.
English: This means that they kill parasites that come into contact with the skin or fur of animals, such as fleas, ticks or flying insects.
Croatian: To znači da ubijaju parazite koji dolaze u dodir s kožom ili dlakom životinja, kao što su buhe, krpelji ili leteći insekti.
English: The application site should be allowed to dry before the dog is allowed to come into contact with fabrics or furnishings.
Croatian: Treba pričekati da se mjesto primjene osuši prije nego što pas dođe u kontakt s tkaninama ili namještajem.
English: If accidental exposure to the eyes occurs, the eyes should be thoroughly rinsed with water and in case of accidental exposure to the skin, the skin should be washed immediately with soap and water.
Croatian: U slučaju nehotičnog dodira s očima, oči treba temeljito isprati vodom, a u slučaju nehotičnog dodira s kožom, kožu treba odmah oprati sapunom i vodom.
English: People applying the medicine should not smoke, eat or drink and should wash their hands thoroughly after handling the product.
Croatian: Tijekom rukovanja ovim VMP-om ne smije se pušiti, jesti ni piti te nakon rukovanja proizvodom treba temeljito oprati ruke.
English: Vectra 3D must not be used on cats and they must not be allowed to groom dogs recently treated with the medicine, as it may cause harmful effects that could be fatal.
Croatian: Vectra 3D ne smije se koristiti u mačaka i njima se ne smije dozvoliti da ližu pse nedavno tretirane VMP-om jer to može imati štetne posljedice koje mogu biti smrtonosne.
English: The active substances in Vectra 3D act as ‘ectoparasiticides'.
Croatian: Djelatne tvari u lijeku Vectra 3D djeluju kao „ektoparaziticidi”.
English: Children must not handle treated dogs for at least four hours after application of the veterinary medicine.
Croatian: Djeca ne smiju dirati tretirane pse barem 24 sata nakon primjene VMP-a.
English: Other information about Vectra 3D
Croatian: Ostale informacije o VMP-u Vectra 3D
English: People with known hypersensitivity (allergy) to any of the ingredients should avoid contact with the product.
Croatian: Osobe koje su preosjetljive (alergične) na bilo koji sastojak lijeka trebaju izbjegavati kontakt s VMPom.
English: The effectiveness of Vectra 3D against fleas, ticks, mosquitoes and flies was investigated in 24 laboratory studies and in two field studies.
Croatian: Učinkovitost VMP-a Vectra 3D protiv buha, krpelja, komaraca i muha ispitivana je u 24 laboratorijska ispitivanja i u dvama terenskim ispitivanjima.
English: The content of one full Vectra 3D applicator is applied directly to the dog's skin, after parting its fur, either in one or more spots on the back, depending on the dog's weight, or in a continuous line along the centre of the back from the base of the tail to the shoulder blades.
Croatian: Nakon što se razmakne dlaka psa, sadržaj jednog punog aplikatora VMP-a Vectra 3D primjenjuje se izravno na njegovu kožu, na jednu ili više točaka na leđima, ovisno o tjelesnoj težini psa, ili u kontinuiranoj liniji uzduž središnjeg dijela leđa od baze repa do lopatica.
English: Its actions last for up to a month, and it prevents fleas from hatching and developing for two months.
Croatian: VMP djeluje do mjesec dana i sprječava lijeganje i razvoj buha tijekom dva mjeseca.
English: Pyriproxyfen is an insect growth regulator which stops the flea life cycle by causing production of infertile eggs as well as blocking development of juvenile flea stages into adults.
Croatian: Piriproksifen je regulator rasta insekata koji zaustavlja životni ciklus buha tako što uzrokuje stvaranje neplodnih jajašca te inhibira razvoj buhe od juvenilnih stadija do odrasle jedinke.
English: What is Vectra 3D and what is it used for?
Croatian: Što je Vectra 3D i za što se koristi?
English: Vectra 3D (dinotefuran / pyriproxyfen / permethrin)
Croatian: Vectra 3D (dinotefuran / piriproksifen / permetrin)
English: Other side effects with Vectra 3D (which may affect up to 1 in 1000 dogs) are behavioural disorders such as increased activity, barking or signs of anxiety, lethargy (lack of energy), or anorexia (loss of appetite), and nervous system signs such as muscle tremor (shaking).
Croatian: Druge nuspojave VMP-a Vectra 3D (koje se mogu javiti u do 1 na 1 000 pasa) jesu promjene u ponašanju, kao što je povećana aktivnost, lajanje ili znakovi tjeskobe, letargija (manjak energije) ili anoreksija (gubitak apetita) te znakovi povezani sa živčanim sustavom, kao što je tremor (drhtanje).
English: The first field study involved 485 dogs with flea and/or tick infestations.
Croatian: Prvo terensko ispitivanje obuhvatilo je 485 pasa s infestacijama buhama i/ili krpeljima.
English: Vectra 3D is a veterinary medicine used on dogs to treat and prevent flea and tick infestations and to repel sand flies, mosquitoes and stable flies.
Croatian: Vectra 3D je veterinarsko-medicinski proizvod koji se koristi u pasa za liječenje i sprječavanje infestacije buhama i krpeljima te za odbijanje pješčanih mušica, komaraca i stajskih muha.
English: The European Medicines Agency decided that Vectra 3D'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 VMP-a Vectra 3D nadmašuju s njim povezane rizike te da se može izdati odobrenje za njegovu primjenu u Europskoj uniji.
English: If skin or eye irritation persists, or if the veterinary medicine is accidentally swallowed, immediate medical advice should be sought and the package leaflet or label shown to the doctor.
Croatian: Ako nadraženost kože ili očiju ne prestaje ili ako se VMP nehotično proguta, odmah treba potražiti savjet liječnika i pokazati mu uputu o VMP-u ili naljepnicu.
English: An overview of Vectra 3D and why it is authorised in the EU
Croatian: Pregled informacija o VMP-u Vectra 3D i zašto je odobren u EU-u
English: What are the risks associated with Vectra 3D?
Croatian: Koji su rizici povezani s VMP-om Vectra 3D?
English: Why is Vectra 3D authorised in the EU?
Croatian: Zašto je Vectra 3D odobren u EU-u?
English: Vectra 3D can be obtained without a prescription and is available as a spot-on solution in applicators of five different strengths for use on dogs of different weights.
Croatian: Vectra 3D se izdaje bez veterinarskog recepta u obliku otopine za nakapavanje u aplikatorima pet različitih jačina za primjenu u pasa različitih težina.
English: The second field study involved 278 dogs with flea infestations which were treated three times at monthly intervals either with Vectra 3D or another spot-on product containing fipronil and (s)methoprene.
Croatian: Drugim terenskim ispitivanjem obuhvaćeno je 278 pasa s infestacijama buhama, koji su bili tretirani tri puta u razmaku od mjesec dana, bilo VMP-om Vectra 3D ili nekim drugim proizvodom za nakapavanje koji sadržava fipronil i (s)-metopren.
English: Dinotefuran acts on nerve receptors called nicotinic acetylcholine receptors and permethrin interferes with sodium channels on nerves that play a role in transmitting signals; when given together, they reinforce each other's action.
Croatian: Dinotefuran djeluje na živčane receptore naziva nikotinski acetilkolinski receptori, a permetrin ometa natrijeve kanale u živcima koji igraju ulogu u prenošenju signala.
English: Dinotefuran and permethrin are insecticides which kill insects by acting on their nervous system by different mechanisms; permethrin also acts similarly on ticks.
Croatian: Dinotefuran i permetrin su insekticidi koji ubijaju insekte tako što djeluju na njihov živčani sustav različitim mehanizmima.
English: Vectra 3D received a marketing authorisation valid throughout the EU on 4 December 2013.
Croatian: Za VMP Vectra 3D izdano je odobrenje za stavljanje u promet koje je na snazi u EU-u od 4. prosinca
English: The most common side effects with Vectra 3D (which may affect up to 1 in 1000 dogs) are short-lived redness, itching or other signs of discomfort at the application site.
Croatian: Najčešće nuspojave VMP-a Vectra 3D (koje se mogu javiti u do 1 na 1 000 pasa) jesu kratkotrajno crvenilo, svrbež ili drugi znakovi nelagode na mjestu primjene.
English: The dogs treated with Vectra 3D had an average tick reduction of 94% over 4 weeks compared with 97% with the other product.
Croatian: U pasa tretiranih VMP-om Vectra 3D prosječno smanjenje broja krpelja iznosilo je 94 % tijekom 4 tjedana, u odnosu na smanjenje od 97 % u pasa tretiranih drugim proizvodom.
English: How does Vectra 3D work?
Croatian: Kako djeluje Vectra 3D?
English: Vectra 3D contains three active substances: dinotefuran, pyriproxyfen and permethrin.
Croatian: Vectra 3D je veterinarskomedicinski proizvod koji sadrži tri djelatne tvari: dinotefuran, piriproksifen i permetrin.
English: For a full list of all side-effects reported with Vectra 3D, see the package leaflet.
Croatian: Potpuni popis svih nuspojava pri primjeni VMP-a Vectra 3D potražite u uputi o VMP-u.
English: What benefits of Vectra 3D have been shown in studies?
Croatian: Koje su koristi od VMP-a Vectra 3D utvrđene u ispitivanjima?
English: How is Vectra 3D used?
Croatian: Kako se Vectra 3D koristi?
English: It showed that Vectra 3D-treated dogs had an average flea count reduction of 95% compared with 97% for the dogs treated with fipronil and (s)-methoprene.
Croatian: Tim je ispitivanjem utvrđeno da se u pasa tretiranih VMP-om Vectra 3D prosječan broj buha smanjio za 95 %, u usporedbi sa smanjenjem od 97 % u pasa tretiranih fipronilom i (s)-metoprenom.
English: It showed that dogs treated once with Vectra 3D had fleas reduced by 79% over the 4 week study period compared with a reduction of 57% for dogs treated once with another spot-on product containing two other substances
Croatian: Utvrđeno je da se broj buha u pasa koji su jednom tretirani VMP-om Vectra 3D smanjio za 79 % tijekom razdoblja ispitivanja od 4 tjedna u odnosu na smanjenje od 57 % u pasa koji su tretirani jednom nekim drugim proizvodom za nakapavanje koji sadržava druge dvije tvari kojima se suzbijaju buhe i krpelji, i to fipronil i (s)-metopren.
English: --1 Each dose (0.007 ml) of undiluted vaccine contains: - Eimeria acervulina, strain 003 - 332-450 sporulated oocysts - Eimeria maxima, strain 013 - 196 - 265 sporulated oocysts - Eimeria mitis, strain 006 - 293 - 397 sporulated oocysts - Eimeria praecox, strain 007 - 293 - 397 sporulated oocysts - Eimeria tenella, strain 004 - 276-374 sporulated oocysts
Croatian: --1 Svaka doza (0,007 ml) nerazrijeđenog cjepiva sadrži: - Eimeria acervulina, soj 003 - 332 - 450 sporuliranih oocista - Eimeria maxima, soj 013 - 196 - 265 sporuliranih oocista - Eimeria mitis, soj 006 - 293 - 397 sporuliranih oocista - Eimeria praecox, soj 007 - 293 - 397 sporuliranih oocista - Eimeria tenella, soj 004 - 276 - 374 sporuliranih oocista
English: This is called ‘overgrowth' or ‘superinfection'.
Croatian: To se naziva „pretjeranim rastom” ili „superinfekcijom”.