FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, contact with skin or eyes should be avoided.
Croatian: Stoga je potrebno izbjegavati kontakt s kožom ili očima.
English: The dose to use is calculated according to the animal's weight.
Croatian: Doza se izračunava na temelju težine životinje.
English: The full EPAR for Zactran can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Zactran nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Why is Zactran approved?
Croatian: Zašto je Zactran odobren?
English: What is Zactran and what is it used for?
Croatian: Što je Zactran i za što se koristi?
English: The cattle may also show signs of slight pain at the site of injection for one day.
Croatian: Goveda također mogu pokazati znakove blage boli na mjestu injekcije u trajanju od jednog dana.
English: The European Commission granted a marketing authorisation valid throughout the EU for Zactran on 24 July 2008.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Zactran na snazi u Europskoj uniji od 24. srpnja 2008.
English: Zactran gamithromycin
Croatian: Zactran gamitromicin
English: This means that the antibiotic may no longer work on bacteria infecting either animals or humans.
Croatian: To znači da postoji mogućnost da antibiotik više ne djeluje na bakterije koje napadaju životinje ili ljude.
English: Zactran may cause irritation to the eyes or the skin.
Croatian: Zactran može prouzročiti nadraženost očiju ili kože.
English: It should also not be used within 2 months of calving in pregnant cows and heifers intended to produce milk for human consumption or within 1 month of lambing in pregnant ewes intended to produce milk for human consumption.
Croatian: Također se ne smije koristiti u roku od dva mjeseca nakon teljenja u gravidnih krava i junica koje će proizvoditi mlijeko za prehranu ljudi ili u roku od mjesec dana nakon janjenja u gravidnih ovaca koje će proizvoditi mlijeko za prehranu ljudi.
English: Cattle weighing more than 250 kg, and pigs and sheep weighing more than 125 kg, will need to have the dose divided and injected at more than one site.
Croatian: Dozu VMP-a za goveda koja teže više od 250 kg i za svinje i ovce koje teže više 125 kg bit će potrebno podijeliti i injicirati je na više mjesta.
English: These local reactions are short-lived and typically resolve within 2 days for pigs and 4 days for sheep.
Croatian: Te lokalne reakcije uglavnom su blage i obično nestanu u roku od dva dana kod svinja i četiri dana kod ovaca.
English: The main measures of effectiveness were respiratory and depression scores as well as body temperature.
Croatian: Glavna mjerila djelotvornosti bili su rezultati za dišni sustav i depresiju te tjelesnu temperaturu.
English: What are the risks associated with Zactran?
Croatian: Koji su rizici povezani s VMP-om Zactran?
English: Zactran can also be used metaphylactically, which means to treat at the same time both diseased cattle and healthy cattle in close contact with them, in order to prevent healthy animals from developing infection and so prevent further spread of the disease.
Croatian: Zactran se također može upotrebljavati metafilaktički, što znači da se istodobno liječi bolesna i zdrava stoka koja je u bliskom kontaktu s bolesnom stokom kako bi se spriječio razvoj infekcija u zdravih životinja te time daljnje širenje bolesti.
English: It is not intended to provide practical advice on how to use Zactran.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni VMP-a Zactran.
English: Zactran is a type of antibiotic called a macrolide that is used to treat the following bacterial infections:
Croatian: Zactran je vrsta antibiotika naziva makrolid, koji se koristi za liječenje sljedećih bakterijskih infekcija:
English: Zactran is given as a single dose, by injection under the skin for cattle and sheep and into muscle for pigs.
Croatian: Zactran se daje kao jednokratna doza, govedima i ovcama injekcijom pod kožu, a svinjama u mišić.
English: Zactran must not be given to animals hypersensitive (allergic) to any macrolide, and must not be used at the same time as other macrolides or another type of antibiotic called lincosamides.
Croatian: Zactran se ne smije davati životinjama koje su preosjetljive (alergične) na bilo koji makrolid i ne smije se koristiti istodobno s drugim makrolidima ili drugom vrstom antibiotika naziva linkozamidi.
English: When using Zactran for metaphylaxis of BRD, the presence of the disease in the herd should be established first;
Croatian: Pri korištenju VMP-a Zactran radi metafilakse BRD-a prvo je potrebno utvrditi prisutnost bolesti u krdu;
English: It works by blocking the bacteria's ribosomes, which are parts of the cells where proteins are produced, and so prevents the bacteria from growing.
Croatian: Djeluje blokiranjem ribosoma bakterija, koji su dio stanica u kojem se proizvode bjelančevine, čime se sprječava rast bakterija.
English: The swelling generally resolves in 3 to 14 days but may persist in some cattle for up to
Croatian: Otekline uglavnom nestaju za 3 do 14 dana, ali u nekih životinja mogu se zadržati i do 35 dana nakon liječenja.
English: • foot rot in sheep caused by Dichelobacter nodosus and Fusobacterium necrophorum needing systemic treatment (treatment reaching the bacteria via the blood stream, e.g. by injection).
Croatian: • truleži papaka u ovaca uzrokovane bakterijama Dichelobacter nodosus i Fusobacterium necrophorus koja se liječi sistemskom terapijom (liječenje koje do bakterija dopire kroz krv, npr. injekcijom).
English: Other information about Zactran
Croatian: Ostale informacije o VMP-u Zactran
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Zactran's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a Zactran nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: If Zactran comes in direct contact with the eyes, they should be flushed immediately with clean water.
Croatian: Ako dođe do izravnog kontakta VMP-a Zactran s očima, potrebno ih je odmah isprati čistom vodom.
English: In a study involving 364 sheep with typical signs of foot rot, 98% of Zactran-treated sheep were successfully treated after 3 weeks compared to 93% of tilmicosin-treated sheep based on lameness scores.
Croatian: U ispitivanju na 364 ovce s tipičnim simptomima truleži papaka, na temelju ljestvice hromosti 98 % ovaca liječenih VMP-om Zactran uspješno je izliječeno nakon tri tjedna, u usporedbi s 93 % ovaca liječenih tilmikozinom.
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or the label should be presented to the doctor.
Croatian: U slučaju nehotičnog samoinjektiranja treba odmah potražiti liječnički savjet te mu pokazati uputu o proizvodu ili etiketu.
English: People with known hypersensitivity (allergy) to similar antibiotics (macrolide class) should avoid contact with Zactran.
Croatian: Osobe koje su preosjetljive (alergične) na slične antibiotike (skupina makrolida) trebaju izbjegavati kontakt s VMP-om Zactran.
English: Treatment success was 97% in the Zactran-treated pigs compared to 93% in the tildipirosin group.
Croatian: Uspješnost liječenja iznosila je 97 % u svinja liječenih VMP-om Zactran u usporedbi s 93 % svinja iz skupine liječene tildipirosinom.
English: Similarly, if Zactran comes into direct contact with skin, the affected area should be washed immediately with clean water.
Croatian: Slično tomu, ako dođe do izravnog kontakta VMP-a Zactran s kožom, zahvaćeno područje potrebno je odmah isprati čistom vodom.
English: This is a summary of the European public assessment report (EPAR) for Zactran.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) veterinarsko-medicinskog proizvoda Zactran.
English: As Zactran is an antibiotic, it is essential to closely follow the instructions in the package leaflet to minimise the development of antibiotic resistance.
Croatian: Budući da je VMP Zactran antibiotik, važno je slijediti upute o VMP-u kako bi se razvoj otpornosti na antibiotik sveo na najmanju moguću mjeru.
English: A second field study in pigs with SRD compared Zactran to tulathromycin, however, in this study Zactran was not as effective as tulathromycin.
Croatian: U drugom terenskom ispitivanju u svinja sa SRD-om, Zactran je uspoređen s tulatromicinom, međutim u tom ispitivanju Zactran nije bio jednako djelotvoran kao tulatromicin.
English: Zactran was shown to be effective in the treatment and metaphylaxis of BRD associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Croatian: Zactran se pokazao djelotvornim u liječenju i metafilaksi BRD-a povezanog s bakterijama Mannheimia haemolytica, Pasteurella multocida i Histophilus somni.
English: The most common side effects with Zactran in cattle (which may affect more than 1 in 10 cattle) are swellings at the site of injection.
Croatian: Najčešće nuspojave VMP-a Zactran (mogu se javiti u više od 1 na 10 goveda) su otekline na mjestu injekcije.
English: The withdrawal period is 64 days for meat from cattle, 16 days for meat from pigs and 29 days for meat from sheep treated with Zactran.
Croatian: Razdoblje karencije za meso goveda liječenih VMP-om Zactran iznosi 64 dana, za meso svinja 16 dana te za meso ovaca 29 dana.
English: Zactran was as effective as tilmicosin in treating severe foot rot in sheep.
Croatian: Zactran se pokazao jednako djelotvornim kao tilmikozin u liječenju teške truleži papaka u ovaca.
English: When treating foot rot in sheep, appropriate flock management measures should be used, such as keeping sheep in a dry environment.
Croatian: Prije liječenja truleži papaka u ovaca treba poduzeti odgovarajuće mjere za stado, kao što je držanje ovaca na suhom.
English: For the metaphylaxis of BRD, the effect of Zactran was studied in comparison to placebo (dummy treatment) in cattle which had been in contact with diseased animals on the same farm and, therefore, likely also to develop the disease.
Croatian: Za metafilaksu BRD-a djelotvornost VMP-a Zactran ispitivana je u usporedbi s placebom (prividnim liječenjem) u goveda koja su bila u dodiru s bolesnim životinjama na istom gospodarstvu te u kojih stoga postoji vjerojatnost za razvoj bolesti.
English: Zactran contains the active substance gamithromycin.
Croatian: Zactran sadrži djelatnu tvar gamitromicin.
English: For the treatment of SRD, a field study was conducted in pigs with SRD comparing Zactran to tildipirosin, another macrolide antibiotic.
Croatian: Za liječenje SRD-a provedeno je terensko ispitivanje u svinja sa SRD-om u kojem je Zactran uspoređen s tildipirosinom, drugim makrolidnim antibiotikom.
English: How is Zactran used?
Croatian: Kako se Zactran koristi?
English: The active substance of Zactran, gamithromycin, is an antibiotic of the macrolide group.
Croatian: Djelatna tvar VMP-a Zactran, gamitromicin, antibiotik je iz skupine makrolida.
English: • swine respiratory disease (SRD), a lung infection in pigs, caused by Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Bordetella bronchiseptica;
Croatian: • respiratorne bolesti svinja (SRD), infekcije dišnih puteva u svinja uzrokovane bakterijama Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuisiBordetella bronchiseptica;
English: The most common side effects with Zactran in pigs and sheep (which may affect up to 1 in 10 animals) are mild to moderate swellings at the site of injection.
Croatian: Najčešće nuspojave VMP-a Zactran u svinja i ovaca (mogu se javiti u do 1 na 10 životinja) blage su do umjerene otekline na mjestu injekcije.
English: The medicine can only be obtained with a prescription and is available as a solution for injection.
Croatian: VMP Zactran izdaje se samo na veterinarski recept i dostupan je u obliku otopine za injekciju.
English: The medicine is not authorised for use in animals producing milk for human consumption.
Croatian: VMP nije odobren za primjenu kod životinja od kojih se dobiva mlijeko za prehranu ljudi.
English: In the treatment of BRD, Zactran was shown to be as effective as tulathromycin.
Croatian: U liječenju BRD-a dokazana je jednaka djelotvornost VMPa Zacrtan kao i tulatromicina.
English: What benefits of Zactran have been shown in studies?
Croatian: Koje su koristi od VMP-a Zactran utvrđene u ispitivanjima?
English: For the treatment of BRD, Zactran was studied in comparison to another macrolide antibiotic (tulathromycin) in cattle already affected by the disease.
Croatian: U liječenju BRD-a Zactran je ispitivan u usporedbi s drugim makrolidnim antibiotikom (tulatromicin) u bolesnih goveda.
English: • bovine respiratory disease (BRD), a lung infection in cattle, caused by the bacteria Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Croatian: • respiratorne bolesti goveda (BRD), infekcije dišnih puteva u stoke uzrokovane bakterijama Mannheimia haemolytica, Pasteurella multocida i Histophilus somni.
English: As the efficacy of antimicrobial treatment of foot rot might be reduced by others factors, such as wet environmental conditions or inappropriate farm management, treatment of foot rot should therefore be undertaken along with other flock management tools.
Croatian: Djelotvornost antimikrobnog liječenja truleži papaka mogu umanjiti drugi čimbenici, kao što su vlažan okoliš ili neadekvatni uvjeti na farmi.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Zactran, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Croatian: U sažetku opisa svojstava i u uputi o VMP-u Zactran nalaze se informacije o sigurnosti primjene, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: How does Zactran work?
Croatian: Kako djeluje Zactran?
English: For practical information about using Zactran, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Zactran vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti veterinaru ili ljekarniku.
English: For the full list of all side effects reported with Zactran, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni VMP-a Zactran potražite u uputi o VMP-u.
English: For more information about treatment with Zactran, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Zactran vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti veterinaru ili ljekarniku.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Croatian: To znači da, iako ne postoji dovoljno dokaza iz kliničkih ispitivanja, učinkovitost ovih biljnih lijekova je vjerojatna te postoji dokaz o njihovoj sigurnoj uporabi na ovaj način tijekom najmanje 30 godina (uključujući najmanje 15 godina na području EU).
English: var. sorbilis (Mart.) Ducke, semen
Croatian: Ducke, semen
English: The HMPC recommended that these medicines should not be used in patients with stomach and gut ulcers, hyperthyroidism (overactive thyroid gland) or cardiovascular problems, such as hypertension (high blood pressure) and arrhythmias (heart rhythm problems).
Croatian: HMPC je preporučio da se ovi lijekovi ne smiju primjenjivati u bolesnika sa čirevima želuca i crijeva, hipertiroidizmom (prekomjerno aktivnom štitnom žlijezdom) ili kardiovaskularnim poremećajima, poput hipertenzije (visokog krvnog tlaka) i aritmija (poremećaja srčanog ritma).
English: Guarana seed should only be used in adults.
Croatian: Sjemenke paulinije smiju se koristiti samo u odraslih osoba.
English: Guarana seed EMA/HMPC/284498/2013
Croatian: Sjemenke paulinije EMA/HMPC/284498/2013
English: If symptoms persist for longer than one week during the use of Guarana seed, a qualified healthcare practitioner should be consulted.
Croatian: Ako se simptomi ne povuku tjedan dana nakon početka uzimanja sjemenki paulinije, potrebno je savjetovati se s kvalificiranim zdravstvenim djelatnikom.
English: Further information on the HMPC assessment of guarana seed medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Dodatne informacije o HMPC-ovoj ocjeni lijekova koji sadrže sjemenkepaulinije, uključujući pojedinosti zaključaka Povjerenstva, mogu se pronaći u rubrici 'All documents' na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Paulinia cupana Kunth ex H.B.K.
Croatian: Paulinia cupana Kunth ex H.B.K. var. sorbilis (Mart.)
English: This summary is not intended to provide practical advice on how to use medicines containing guarana seed.
Croatian: Svrha ovog sažetka nije pružanje praktičnih savjeta o načinu uporabe lijekova koji sadrže sjemenke paulinije.
English: Any applications for the licensing of medicines containing guarana seed have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Croatian: Svi zahtjevi za odobrenje lijekova koji sadrže sjemenke paulinije moraju se podnijeti nacionalnim tijelima nadležnim za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: Further information on the risks associated with guarana seed medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Više informacija o rizicima povezanim s lijekovima koji sadrže sjemenke paulinije, uključujući odgovarajuće mjere opreza za njihovu sigurnu uporabu, možete pronaći u monografiji u rubrici 'All documents' na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC conclusions on the use of guarana seed medicines for fatigue and weakness are based on their ‘traditional use'.
Croatian: Zaključci HMPC-a o uporabi lijekova koji sadrže sjemenke paulinije za umor i slabost temelje se na „tradicionalnoj uporabi”.
English: Guarana seed can also be found in combination with other herbal substances in some herbal medicines.
Croatian: Sjemenke paulinije prisutne su također i u kombinaciji s drugim biljnim tvarima u određenim biljnim lijekovima.
English: Information on the use and licensing of guarana seed medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o uporabi i odobrenju za lijekove koji sadrže sjemenke paulinije u državama članicama Europske unije mogu se dobiti od nadležnih nacionalnih tijela.
English: Herbal medicines containing guarana seed are usually available in solid forms to be taken by mouth.
Croatian: Biljni lijekovi koji sadrže sjemenke paulinije obično su dostupni u krutom obliku i uzimaju se kroz usta.
English: What is guarana seed?
Croatian: Što su sjemenke paulinije?
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing guarana seed.
Croatian: Države članice Europske unije uzimaju u obzir zaključke HMPC-a prilikom ocjenjivanja zahtjeva za odobrenje biljnih lijekova koji sadrže sjemenke paulinije.
English: Guarana seed is the common name for the seed of the plant Paulinia cupana Kunth ex H.B.K.
Croatian: Sjemenke paulinije su uobičajeni naziv za sjemenke biljke Paulinia cupana Kunth ex H.B.K. var. sorbilis (Mart.)
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of guarana seed.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Povjerenstva za biljne lijekove (HMPC) u pogledu medicinske uporabe sjemenki paulinije.
English: The HMPC concluded that, on the basis of its long-standing use, guarana seed can be used for the relief of symptoms of fatigue (tiredness) and weakness.
Croatian: Zaključak HMPC-a je da se, na temelju njihove dugogodišnje uporabe, sjemenke guarane mogu koristiti za ublažavanje simptoma umora i slabosti.
English: EMA/HMPC/284498/2013
Croatian: EMA/HMPC/284498/2013 Povjerenstvo za biljne lijekove (HMPC)
English: In its assessment, the HMPC considered studies on the effects of guarana seed on behaviour, which showed that it had a stimulant effect and led to improvements in symptoms of fatigue.
Croatian: HMPC je prilikom ocjene, razmotrio studije o učinku sjemenki paulinije na ponašanje, u kojima se pokazalo da sjemenke paulinije ima stimulativni učinak i dovode do smanjenja simptoma umora.
English: Detailed instructions on how to take guarana seed medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: Detaljne upute o tome kako uzimati lijekove koji sadrže sjemenke paulinije i tko ih može uzimati dostupne su u uputi o lijeku koja je priložena uz lijek.
English: Guarana seed preparations are obtained by drying and powdering the seeds.
Croatian: Pripravci sjemenki paulinije dobivaju se sušenjem i usitnjavanjem sjemenki u prašak.
English: Other information about guarana seed medicines
Croatian: Ostale informacije o lijekovima koji sadrže sjemenke paulinije
English: What are the risks associated with guarana seed medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže sjemenke paulinije?
English: For practical information about using guarana seed medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Croatian: Za praktične informacije o uporabi lijekova koji sadrže sjemenke paulinije bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svom liječniku ili ljekarniku.
English: For more information about treatment with guarana seed medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekovima koji sadrže sjemenke paulinije pročitajte u uputi o lijeku priloženoj uz lijek odnosno obratite se svom liječniku ili ljekarniku.
English: What evidence supports the use of guarana seed medicines?
Croatian: Koji dokazi potkrjepljuju uporabu lijekova koji sadrže sjemenke paulinije?
English: Guarana seed
Croatian: Sjemenke paulinije
English: How are guarana seed medicines approved in the EU?
Croatian: Kako se u Europskoj uniji odobravaju lijekovi koji sadrže sjemenkepaulinije?
English: --1 Cell-associated live recombinant turkey herpesvirus expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus: 103.3 - 104.6 PFU* * PFU: plaque forming units.
Croatian: --1 4Živi rekombinirani, stanično vezan herpesvirus pura koji izražava fuziju proteina virusa Newcastle bolesti i VP2 proteina virusa zarazne bolesti burze: 103,3 - 104,6 PFU*
English: Invented name Strength Pharmaceutical form
Croatian: Jačina Farmaceutski oblik
English: Withdrawal period
Croatian: Suspenzija :1 ampula
English: Always take Xagrid exactly as your doctor has told you.
Croatian: Uvijek uzmite Xagrid točno onako kako Vam je rekao liječnik.
English: 9/l or
Croatian: 9/l ili
English: The amount of Xagrid that people take can be different, and this depends on your condition.
Croatian: Količina lijeka Xagrid koju ljudi uzimaju može biti različita, a to ovisi o Vašem stanju.