FrancophonIA/ELRC3.0 huggingface dataset:
English: The agreed harmonised dose for both indications was 40,000 IU apramycin per kg bw (corresponding to 72 mg of product/kg bw), daily for 5 consecutive days.
Croatian: Dogovorena usklađena doza za obje indikacije bila je 40 000 IU apramicina po kg tm dnevno (što odgovara količini od 72 mg proizvoda/kg tm) tijekom 5 uzastopnih dana.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to apramycin or any other aminoglycoside should avoid contact with the product.
Croatian: Osobe preosjetljive na apramicin ili bilo koji drugi aminoglikozid trebaju izbjegavati kontakt s proizvodom.
English: Do not use in calves with functional rumen.
Croatian: Ne primjenjivati kod teladi s funkcionalnim buragom.
English: MIC90 of European isolates of E. coli for apramycin was demonstrated to be 16 μg/ml with a wild-type cut-off value of ≥32 μg/ml.
Croatian: Dokazano je da MIC90 europskih izolata bakterije E. coli za apramicin iznosi 16 μg/ml, uz graničnu vrijednost od ≥32 μg/ml za sojeve divljeg tipa.
English: • the CVMP reviewed the summary of product characteristics, labelling and package leaflet proposed by the marketing authorisation holder and considered all the overall submitted data; the CVMP has recommended the amendment of the marketing authorisations for Girolan and its associated name Apralan as referred in Annex I for which the summary of product characteristics, labelling and package leaflet are set out in Annex III.
Croatian: CVMP preporučuje izmjenu odobrenja za stavljanje VMP-a u promet za Girolan i pridruženo ime Apralan kako je navedeno u Prilogu I., za koji su sažetak opisa svojstava VMP-a, označivanje i uputa o VMP-u navedeni u Prilogu III.
English: Meat and offal: Zero days.
Croatian: Meso i iznutrice: 0 dana.
English: 4.2 Indications for use, specifying the target species
Croatian: 4.2 Indikacije za primjenu, navesti ciljne vrste životinja Svinje (odbijena prasad):
English: Shelf life after first opening the immediate packaging: use immediately.
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakiranja: odmah upotrijebiti.
English: Apramycin sulfate equivalent to 1000 g apramycin activity per bag.
Croatian: Apramicin-sulfat ekvivalentan 1000 g aktivnosti apramicina po vreći.
English: In the case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju da se proizvod nehotice proguta, odmah potražite pomoć liječnika i pokažite mu uputu o VMP ili etiketu.
English: According to the assessment performed, Salmonella can be considered eligible to be listed for Union intervention as laid down in Article 5(3) of the Animal Health Law.
Croatian: Unije kako je utvrđeno u članku 5. stavku 3. Zakona o zdravlju životinja.
English: Council as regards requirements for the use of specific control methods in the framework of the national programmes for the control of salmonella in poultry - link disease caused by Salmonella Pullorum is considered an exceptional circumstance that would require to treat (or slaughter) clinically affected flocks.
Croatian: Council as regards requirements for the use of specific control methods in the framework of the national programmes for the control of salmonella in poultry - link kontrolnim programima za perad uspostavljenima u Europi tih ju pet serovara kolokvijalno poznato kao zoonotski.
English: MIC90 values from a large pan-European study have been calculated for apramycin against E. coli from pigs as 16 μg/ml.
Croatian: U okviru velike paneuropske studije izračunano je da vrijednosti MIK90 za apramicin protiv bakterije E. coli iz svinja iznose 16 μg/ml.
English: Do not use within 4 weeks of the start of the laying period.
Croatian: Nije dopuštena upotreba unutar prva četiri tjedna razdoblja nesenja.
English: Avda.
Croatian: Abt.
English: Each sachet contains 2 x 106 IU apramycin sulfate and weight of 3.6 g of product.
Croatian: Svaka vrećica sadržava 2 x 106 IU apramicin-sulfata i 3,6 g proizvoda.
English: Dose (mg product per kg bodyweight per day)
Croatian: Doza (mg VMP/kg tjelesne mase/dan)
English: It should be noted that in some Member States Girolan was also authorised for use against Salmonella in pigs, however the marketing authorisation holder decided to remove this indication, as it could not be supported.
Croatian: Potrebno je napomenuti da je Girolan u nekim državama članicama odobren i za primjenu protiv bakterije Salmonella u svinja.
English: 4.8 Interaction with other medicinal products and other forms of interaction
Croatian: 4.8 Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija Aminoglikozidi mogu imati negativan utjecaj na funkciju bubrega.
English: MARKETING AUTHORISATION HOLDER To be completed nationally.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE U PROMET Ispuniti na nacionalnoj razini.
English: STATEMENT OF ACTIVE SUBSTANCES 1 g contains 552,000 IU apramycin (as apramycin sulfate)
Croatian: SASTAV DJELATNIH TVARI 1 g sadržava 552 000 IU apramicina (u obliku apramicin-sulfata)
English: • the CVMP considered the scope of the referral was the harmonisation of the summary of product characteristics, labelling and package leaflet;
Croatian: • CVMP je zaključio da se postupak upućivanja odnosi na usklađivanje sažetka opisa svojstava
English: Pigs (weaned piglets)
Croatian: Svinje (odbijena prasad)
English: The dosage, route and frequency of administration are those proposed in the product information.
Croatian: Doze, put i učestalost primjene jednaki su dozama, putu i učestalosti predloženima u informacijama o VMP-u.
English: SPC section 6.3
Croatian: Dio 6.3.
English: Each bag contains 1,000 x 106 IU apramycin sulfate and weight of 1,812 g of product.
Croatian: Svaka vreća sadržava 1000 x 106 IU apramicin-sulfata i 1812 g proizvoda.
English: MIC90 values from a large pan-European study have been calculated for apramycin against E. coli from calves as 16 μg/ml.
Croatian: U okviru velike paneuropske studije izračunano je da vrijednosti MIK90 za apramicin protiv bakterije E. coli iz teladi iznose 16 μg/ml.
English: Calves: Calves were given apramycin in milk replacer daily for five days, at doses up to 120 mg/kg of bodyweight.
Croatian: Telad: telad je primila apramicin u zamjenskom mlijeku svaki dan tijekom pet dana, u dozama do
English: Nature and composition of immediate packaging:
Croatian: 17. OSTALE INFORMACIJE Osobine i sastav unutarnjeg pakovanja:
English: Scientific Opinion on the assessment of listing and categorisation of animal diseases within the framework of the Animal Health Law (Regulation (EU) No 2016/429): Salmonella infection in poultry with serotypes of animal health relevance (S. Pullorum, S. Gallinarum and S. arizonae).
Croatian: Scientific Opinion on the assessment of listing and categorisation of animal diseases within the framework of the Animal Health Law (Regulation (EU) No 2016/429):
English: MARKETING AUTHORISATION NUMBER(S) To be completed nationally.
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET Ispuniti na nacionalnoj razini.
English: Administer 12,500 IU apramycin sulfate per kilogram of bodyweight (corresponding to 22.5 mg of product/kg bw), daily for 7 consecutive days.
Croatian: Upotrijebite 12 500 IU apramicin-sulfata po kilogramu tjelesne mase (što odgovara 22,5 mg proizvoda/kg t.m.) dnevno, tijekom 7 uzastopnih dana.
English: Apramycin sulfate equivalent to 1 g apramycin activity per sachet.
Croatian: Apramicin-sulfat ekvivalentan 1 g aktivnosti apramicina po vrećici.
English: Pigs (weaned piglets):
Croatian: Svinje (odbijena prasad):
English: A wild-type cut-off value of ≥32 μg/ml for E. coli of cattle origin has been proposed.
Croatian: Za bakteriju E. coli koja potječe od goveda predložena je granična vrijednost od ≥32 μg/ml za sojeve divljeg tipa.
English: STATEMENT OF THE ACTIVE SUBSTANCE (S) AND OTHER INGREDIENTS 1 g contains 552,000 IU apramycin (as apramycin sulfate) Light to medium brown granular powder.
Croatian: 1 g sadržava 552 000 IU apramicina (u obliku apramicin-sulfata) Granulirani prašak svijetle do srednje smeđe boje.
English: Excipients:
Croatian: Apsorpcija:
English: In order to obtain the correct dose, the concentration of the veterinary medicinal product has to be adjusted accordingly.
Croatian: potrebno je prilagoditi koncentraciju VMP.
English: Aminoglycosides may cause neuromuscular blockade.
Croatian: Aminoglikozidi mogu izazvati neuromuskularnu blokadu, što je potrebno uzeti u obzir prilikom anesteziranja tretiranih životinja.
English: In support of the proposed indication ‘Treatment and metaphylaxis of bacterial enteritis caused by Escherichia coli susceptible to apramycin', the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Croatian: Kako bi potkrijepio predloženu indikaciju „liječenje i metafilaksa bakterijskog enteritisa prouzročenog bakterijom Escherichia coli osjetljivom na apramicin”, nositelj odobrenja dostavio je in vitro podatke o osjetljivosti i kliničke podatke, uključujući terenske studije.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE - COMBINED LABEL AND PACKAGE LEAFLET
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJUKOMBINIRANA ETIKETA
English: Administer 80,000 IU apramycin sulfate per kilogram of bodyweight (corresponding to 144 mg of product/kg bw), daily for 5 consecutive days.
Croatian: Upotrijebite 80 000 IU apramicin-sulfata po kilogramu tjelesne mase (što odgovara 144 mg proizvoda/kg t.m.) dnevno, tijekom 5 uzastopnih dana.
English: Cattle, pigs, chickens, rabbits
Croatian: Goveda, svinje, kokoši, kunići
English: To support it, the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Croatian: Kako bi to potkrijepio, nositelj odobrenja za stavljanje u promet dostavio je in vitro podatke o osjetljivosti i kliničke podatke, uključujući terenske studije.
English: The clinical data provided demonstrated that Girolan was effective in the treatment of bacterial enteritis caused by E. coli and clinical outbreaks due to Salmonella Dublin when administered at 40,000 IU apramycin per kilogram of bodyweight (corresponding to 72 mg of product/kg bw), daily for 5 consecutive days.
Croatian: Pruženi klinički podatci dokazuju da se Girolan pokazao djelotvornim u liječenju bakterijskog enteritisa prouzročenog bakterijom E. coli i kliničkih epidemija zbog bakterije Salmonella Dublin kada se primjenjivao na dnevnoj osnovi pri dozi od 40 000 IU apramicina po kilogramu tjelesne mase (što odgovara količini od 72 mg proizvoda/kg tm) tijekom pet uzastopnih dana.
English: A wild-type cut-off value of ≥32 μg/ml for E. coli of pig origin has been proposed.
Croatian: Za bakteriju E. coli koja potječe od svinja predložena je granična vrijednost od ≥32 μg/ml za sojeve divljeg tipa.
English: Treatment and metaphylaxis of bacterial enteritis caused by Escherichia coli susceptible to apramycin.
Croatian: Liječenje i metafilaksa bakterijskog enteritisa uzrokovanog bakterijom Escherichia coli osjetljivom na apramicin.
English: The provided clinical data demonstrated that Girolan was effective in the treatment of colibacillosis when administered at 80,000 IU apramycin per kilogram of bodyweight (corresponding to 144 mg of product/kg bw), daily for 5 consecutive days.
Croatian: Dostavljenim kliničkim podatcima dokazano je da je Girolan djelotvoran u liječenju kolibaciloze kada se primjenjivao na dnevnoj osnovi pri dozi od 80 000 IU apramicina po kilogramu tjelesne mase (što odgovara količini od 144 mg proizvoda/kg tm) tijekom pet uzastopnih dana.
English: In support of the indication for treatment of bacterial enteritis caused by E. coli and clinical outbreaks due to Salmonella Dublin the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Croatian: Kako bi potkrijepio indikaciju za liječenje bakterijskog enteritisa prouzročenog bakterijom E. coli i kliničkih epidemija zbog bakterije Salmonella Dublin, nositelj odobrenja dostavio je in vitro podatke o osjetljivosti i kliničke podatke, uključujući terenske studije.
English: Treatment of bacterial enteritis caused by Escherichia coli and clinical outbreaks due to Salmonella enterica subsp.
Croatian: Liječenje bakterijskog enteritisa uzrokovanog bakterijom Escherichia coli i kliničke epidemije uzrokovane bakterijom Salmonella enterica subsp. enterica serovar Dublin (Salmonella Dublin)
English: Administer 20,000 IU apramycin sulfate per kilogram of bodyweight (corresponding to 36 mg of product/kg bw), daily for 5 consecutive days.
Croatian: Upotrijebite 20 000 IU apramicin-sulfata po kilogramu tjelesne mase (što odgovara 36 mg proizvoda/kg t.m.) dnevno, tijekom 5 uzastopnih dana.
English: Grounds for amendment of the summary of product characteristics, labelling and package leaflet
Croatian: Razlozi za izmjenu sažetka opisa svojstava VMP-a, označivanja i uputa o VMP-u
English: Calves.
Croatian: Telad.
English: TARGET SPECIES Pigs, calves, chickens and rabbits.
Croatian: CILJNE VRSTE ŽIVOTINJA Svinje, telad, kokoši, kunići
English: Antimicrobial treatment of meat-producing birds increases the risk of carcase contamination with resistant Salmonella spp.
Croatian: Antimikrobno liječenje ptica za proizvodnju mesa povećava rizik od kontaminacije trupla otpornim bakterijama Salmonella spp. i Campylobacter spp. te otpornim nametničkim bakterijama, što ujedno može prenijeti gene za otpornost na druge bakterije.
English: Seven trials were conducted as a blind study in Greece, Italy, Spain and the UK.
Croatian: U Grčkoj, Italiji, Španjolskoj i Ujedinjenoj Kraljevini provedeno je sedam ispitivanja u obliku slijepih studija.
English: The provided clinical data demonstrated that Girolan was effective in the treatment of bacterial enteritis caused by E. coli when administered at 12,500 IU apramycin per kg bw (corresponding to 22.5 mg of product/kg bw), daily for 7 consecutive days.
Croatian: Dostavljenim kliničkim podatcima dokazano je da je Girolan djelotvoran u liječenju bakterijskog enteritisa prouzročenog bakterijom E. coli kada se primjenjivao na dnevnoj osnovi pri dozi od 12 500 IU apramicina po kg tm (što odgovara količini od 22,5 mg proizvoda/kg tm) tijekom sedam uzastopnih dana.
English: 'Salmonella Dublin in Irish cattle' Vet Ireland J 4:642-3
Croatian: O´Leary, C. 2014. 'Salmonella Dublin in Irish cattle'
English: To support this indication, the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Croatian: Kako bi potkrijepio tu indikaciju, nositelj odobrenja dostavio je in vitro podatke o osjetljivosti i kliničke podatke, uključujući terenske studije.
English: Withdrawal periods: Pigs:
Croatian: INDIKACIJE Svinje (odbijena prasad):
English: The provided clinical data demonstrated that Girolan was effective in the treatment and metaphylaxis of bacterial enteritis caused by Escherichia coli when administered at 20,000 IU apramycin per kilogram of bodyweight (corresponding to 36 mg of product/kg bw), daily for 5 consecutive days.
Croatian: Dostavljenim kliničkim podatcima dokazano je da je Girolan djelotvoran u liječenju i metafilaksi bakterijskog enteritisa prouzročenog bakterijom E. coli kada se primjenjuje u dozi od 20 000 IU apramicina po kilogramu tjelesne mase (što odgovara iznosu od 36 mg proizvoda/kg tm) svakodnevno tijekom pet uzastopnih dana.
English: Administer 40,000 IU apramycin sulfate per kilogram of bodyweight (corresponding to 72 mg of product/kg bw), daily for 5 consecutive days.
Croatian: Upotrijebite 40 000 IU apramicin-sulfata po kilogramu tjelesne mase (što odgovara 72 mg proizvoda/kg t.m.) dnevno, tijekom 5 uzastopnih dana.
English: Calves, pigs, chickens
Croatian: Telad, svinje, kokoši
English: Pre-ruminant calves
Croatian: Streptomyces tenebrarius.
English: To be administered via the drinking water.
Croatian: Za primjenu u pitkoj vodi.
English: Calves, pigs, rabbits
Croatian: Telad, svinje, kunići
English: In support of the indication for treatment of colibacillosis the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Croatian: Kako bi potkrijepio indikaciju za liječenje kolibaciloze, nositelj odobrenja dostavio je in vitro podatke o osjetljivosti i kliničke podatke, uključujući terenske studije.
English: High density polyethylene bottle with polypropylene screw cap. Each bottle contains 50 x 106 IU apramycin and weight of 91 g of product.
Croatian: Svaka boca sadržava 50 x 106 IU apramicin-sulfata i 91 g proizvoda.
English: Summary of product characteristics, labelling and package leaflet
Croatian: Dodatak III Sažetak opisa svojstva, označavanje i uputa o VMP
English: In support of the indication for treatment and metaphylaxis of bacterial enteritis caused by E. coli the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Croatian: Kako bi potkrijepio indikaciju za liječenje i metafilaksu bakterijskog enteritisa prouzročenog bakterijom E. coli, nositelj odobrenja dostavio je in vitro podatke o osjetljivosti i kliničke podatke, uključujući terenske studije.
English: and Campylobacter spp.
Croatian: Sažetka opisa svojstava VMP-a
English: apramycin sulfate and weight of 91 g of product.
Croatian: apramicin-sulfata i 1,8 g proizvoda.
English: Treatment of bacterial enteritis caused by Escherichia coli susceptible to apramycin.
Croatian: Liječenje bakterijskog enteritisa uzrokovanog bakterijom Escherichia coli osjetljivom na apramicin.
English: Active substance:
Croatian: Predpreživačka telad:
English: In support of the indication for treatment of bacterial enteritis caused by E. coli the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Croatian: Kako bi potkrijepio indikaciju za liječenje bakterijskog enteritisa prouzročenog bakterijom E. coli, nositelj odobrenja dostavio je in vitro podatke o osjetljivosti i kliničke podatke, uključujući terenske studije.
English: There was no toxic effect.
Croatian: 120 mg/kg t.m. Nije bilo toksičnog učinka.
English: INDICATION(S) Read the package leaflet before use.
Croatian: Prije primjene pročitati upute za uporabu.
English: Treatment of colibacillosis caused by Escherichia coli susceptible to apramycin.
Croatian: Liječenje kolibaciloze uzrokovane bakterijom Escherichia coli osjetljivom na apramicin.
English: Interaction with other medicinal products and other forms of interaction:
Croatian: Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija: Aminoglikozidi mogu imati negativan utjecaj na funkciju bubrega.
English: In support of the proposed indication, ‘Treatment of bacterial enteritis caused by Escherichia coli and clinical outbreaks due to Salmonella enterica subsp.
Croatian: Predložena indikacija bila je „liječenje kolibaciloze prouzročene bakterijom Escherichia
English: 'Salmonella Serovars And Their Host Specificity.'
Croatian: 3 741-744 3 Vikash Singh. 2013. 'Salmonella Serovars And Their Host Specificity.'
English: Powder for drinking solution
Croatian: Polígono Industrial de Alcobendas
English: This information can be coordinated at individual Member States level.
Croatian: Te se informacije mogu koordinirati na razini pojedine države članice.
English: Furthermore the blood pressure of patients should be carefully monitored.
Croatian: Nadalje je potrebno pažljivo nadzirati krvni tlak bolesnica.
English: The analysis of case reports from the literature was hampered by the limited information available.
Croatian: Analiza slučajeva iz literature bila je ugrožena ograničenim brojem dostupnih informacijama.
English: Overall, considering the substantial exposure to this active substance, the PRAC considered the number of cases as low.
Croatian: Općenito, uzimajući u obzir značajnu izloženost ovoj djelatnoj tvari, PRAC je smatrao da je broj slučajeva nizak.
English: The PRAC also considered the available data on the efficacy of these products;
Croatian: PRAC je također razmatrao dostupne podatke o djelotvornosti tih lijekova.
English: Avoiding the elective use of this drug in patients with pregnancy-induced hypertension might constitute a reasonable clinical response to these findings.
Croatian: Izbjegavanje elektivne uporabe ovog lijeka u bolesnika s hipertenzijom uzrokovanom trudnoćom može predstavljati razuman klinički odgovor na te nalaze.
English: From the pathogenic point of view, it is likely that vasospasm is responsible for these events.
Croatian: Sa stajališta patogenosti, vjerojatno je da je vazospazam odgovoran za ta stanja.
English: In the European Union (EU) it is also used to treat other conditions, such as hyperprolactinaemia and Parkinson's disease; however these indications are not in the scope of this European review.
Croatian: U Europskoj uniji (EU) također se koristi za liječenje drugih stanja poput hiperprolaktinemije i Parkinsonove bolesti; međutim te indikacije nisu predmet ove europske procjene.
English: Indeed, as per the posology one dose given should not exceed 2.5 mg.
Croatian: Naime, prema doziranju jedna doza ne smije premašiti 2,5 mg.
English: This is considered an appropriate risk minimisation measure to reduce the misuse of the product.
Croatian: To je smatrano odgovarajućom mjerom smanjenja rizika kako bi se smanjila zlouporaba lijeka.
English: In the clinical trial assessing the efficacy of bromocriptine in late post-partum, treatment was initiated at times covering adequately the late post-partum period (10 to 13.8 days post-partum and 38.9 days to 16.7 weeks post-partum).
Croatian: U kliničkom ispitivanju kojim se procjenjivalo djelotvornost bromokriptina u kasnom postpartalnom razdoblju, liječenje je započeto u razdoblju koje je odgovarajući pokrivalo kasni dio postpartalnog razdoblja (10 do 13,8 dana postpartalnog razdoblja i 38,9 dana do 16,7 tjedana postpartalnog razdoblja).
English: The absolute number of cases reported in post-marketing is low, especially given the fact that bromocriptine has been available in the EU since 1973, with a substantial patient exposure; overall incidence rates are estimated to 0.005% to 0.04%.
Croatian: Apsolutni broj slučajeva prijavljenih nakon stavljanja lijeka u promet je nizak, posebice uzevši u obzir činjenicu da je bromokriptin dostupan u državama EU-a od 1973. godine sa značajnom izloženosti bolesnica; ukupne stope incidencije procijenjene su na 0,005% do 0,04%.
English: The PRAC concluded that these should not be mentioned in the product information as examples of situations where bromocriptine could be used.
Croatian: PRAC je zaključio da se te informacije ne smiju navoditi u informacijama o lijeku kao primjeri slučajeva u kojima se bromokriptin smije koristiti.
English: Scientific conclusions and grounds for variation to the terms of the marketing authorisations
Croatian: Znanstveni zaključci i temelji za izmjene uvjeta odobrenja za stavljanje lijeka u promet
English: Nevertheless, further information and awareness among the healthcare professionals is advisable to ensure safe use of the product.
Croatian: Bez obzira na sve, preporučuje se prikupljanje daljnjih informacija od zdravstvenih djelatnika kako bi se osigurala sigurna uporaba lijeka.
English: No causal association was shown in the three observational studies investigating the risk of seizures, (Rothman, 1990) cardio- and cerebrovascular events, (Herings, 1995) and hypertension (Watson, 1989).
Croatian: Nije dokazana uzročna povezanost u tri opservacijska ispitivanja koja su proučavala rizik od napadaja (Rothman, 1990.), kardiovaskularna i cerebrovaskularna stanja, (Herings, 1995.) i hipertenzija (Watson, 1989.).