FrancophonIA/ELRC3.0 huggingface dataset:
English: Ruconest is a medicine used to treat attacks of hereditary angioedema in adults and adolescents.
Croatian: Ruconest je lijek koji se koristi u liječenju napadaja nasljednog angioedema u odraslih osoba i adolescenata.
English: Ruconest can only be obtained with a prescription and treatment should be started under the supervision of a doctor with experience in diagnosing and treating hereditary angioedema.
Croatian: Ruconest se izdaje samo na recept, a terapiju treba započeti pod nadzorom liječnika iskusnog u dijagnosticiranju i liječenju nasljednog angioedema.
English: The company that markets Ruconest will ensure that healthcare professionals who are expected to prescribe Ruconest are provided with an educational pack containing information on the proper use of the medicine and warnings about the risk of allergy.
Croatian: Tvrtka koja lijek Ruconest stavlja na tržište osigurat će da zdravstveni radnici za koje se očekuje da će propisivati Ruconest prime edukacijske pakete koji sadrže informacije o ispravnoj primjeni lijeka i upozorenja o riziku od alergije.
English: Ruconest was studied in two main studies involving a total of 70 adults and adolescents with hereditary angioedema caused by low levels of C1 esterase inhibitor protein.
Croatian: Ruconest je ispitivan u dvama glavnim ispitivanjima kojima je obuhvaćeno ukupno 70 odraslih osoba i adolescenata s nasljednim angioedemom uzrokovanim niskim koncentracijama proteina inhibitora C1 esteraze.
English: How does Ruconest work?
Croatian: Kako djeluje Ruconest?
English: For more information about treatment with Ruconest, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Ruconest pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: What benefits of Ruconest have been shown in studies?
Croatian: Koje su koristi lijeka Ruconest dokazane u ispitivanjima?
English: The C1 esterase inhibitor protein is required to control the ‘complement' and ‘contact' systems, collections of proteins in the blood that fight against infection and cause inflammation.
Croatian: Protein naziva inhibitor C1 esteraze potreban je za kontrolu sustava kontakta i komplemenata, nakupina proteina u krvi koji se bore protiv infekcije i uzrokuju upalu.
English: The CHMP decided that Ruconest's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Ruconest nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: How is Ruconest used?
Croatian: Kako se Ruconest koristi?
English: Ruconest is used in patients with hereditary angioedema that is linked to naturally low levels of a protein called ‘C1 esterase inhibitor'.
Croatian: Ruconest se primjenjuje u bolesnika s nasljednim angioedemom koji je povezan s prirodno niskim koncentracijama proteina koji se naziva „inhibitor C1 esteraze”.
English: The active substance in Ruconest, conestat alfa, is a copy of the C1 esterase inhibitor protein and wor ks in the same way as the natural human protein.
Croatian: Djelatna tvar u lijeku Ruconest, konestat alfa, kopija je proteina inhibitora C1 esteraze i djeluje na jednak način kao prirodni humani protein.
English: Ruconest must not be used in patients with known or suspected allergy to rabbits.
Croatian: Ruconest se ne smije primjenjivati u bolesnika s utvrđenom alergijom na kuniće ili u bolesnika za koje se sumnja da su alergični na kuniće.
English: Ruconest contains the active substance conestat alfa.
Croatian: Lijek sadrži djelatnu tvar konestat alfa.
English: For the full list of all side effects reported with Ruconest, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Ruconest potražite u uputi o lijeku.
English: Over 50 different enzymes have been identified.
Croatian: Identificirano je više od 50 različitih enzima.
English: This mechanism takes place at high concentrations.
Croatian: Ovaj se mehanizam odvija u visokim koncentracijama.
English: Discussion of the data available
Croatian: Rasprava o dostupnosti podataka
English: Estonia Interchemie werken "De Adelaar" Eesti AS
Croatian: Estonija Interchemie werken "De Adelaar" Eesti AS
English: The Committee concluded that most of the current broad indications would not be supported by data.
Croatian: Odbor je zaključio kako većina aktualnog širokog spektra indikacija ne bi bila podržana podacima.
English: With relation to the already approved target species horses, the wording below should be used:
Croatian: Za već odobrenu ciljnu vrstu konja treba koristiti niže navedeni tekst:
English: The interpretation of the EU legislation and consideration of compliance with the legal provisions of Article 6(3) of the Directive are not within the remit of the Committee and therefore these issues are not addressed in the assessment of the referral procedure.
Croatian: Tumačenje EU zakonodavstva i razmatranje sukladnosti s pravnim odredbama članka 6.(3) Direktive ne ubraja se u zadaće Odbora te stoga ova pitanja nisu obuhvaćena ocjenom postupka upućivanja.
English: It is currently included in the list of essential medicines for human use of the World Health Organisation (WHO).
Croatian: Trenutno je uvršten u popisu osnovnih lijekova za primjenu u ljudi Svjetske zdravstvene organizacije (World Health Organisation, WHO-a)).
English: There are insufficient data available to support the currently approved indications.
Croatian: Trenutno nema dovoljno dostupnih podataka koji bi podržali aktualno odobrene indikacije.
English: All other dosing regimens appear to be approved based on expert reports, scientific publications and PK/PD characteristics.
Croatian: Svi se ostali režimi doziranja čine odobrenima na temelju izvješća stručnjaka, znanstvenih publikacija i FK/FD značajki.
English: ATCvet code: QJ01GB03
Croatian: ATCvet kod: QJ01GB03
English: Foals, calves, sucklings - the first month of life
Croatian: Ždrjebad, telad, sisavci - prvi mjesec života
English: Do not exceed the proposed dosing regimen.
Croatian: Ne premašujte predloženi režim doziranja.
English: The dosing regimen must not be exceeded.
Croatian: Režim doziranja se ne smije premašiti.
English: Spain MEVET, S.A.U Poligono Industrial El Segre, Parcela 409-410
Croatian: Španjolska MEVET, S.A.U Poligono Industrial El Segre, Parcela 409-410
English: 24010 León Spain
Croatian: 24010 León Španjolska
English: Spain CENAVISA Camí Pedra Estela s/n 43205 Reus Tarragona) Spain
Croatian: Španjolska CENAVISA Camí Pedra Estela s/n 43205 Reus Tarragona)
English: 43206 Tarragona Spain
Croatian: 43206 Tarragona Španjolska
English: Most of the injectable products for horses containing gentamicin were initially approved in the 1980s and 1990s, and (compared to current requirements) only very limited data are available to support indications or dosing regimens in horses.
Croatian: Većina injektibilnih proizvoda za konje koji sadrže gentamicin prvenstveno je odobrena u 1980.-ima i 1990.-ima, te (uspoređujući s trenutnim zahtjevima) dostupni su samo vrlo ograničeni podaci koji podržavaju indikacije ili režime doziranja u konja.
English: Lithuania LABORATORIOS SYVA, S.A. Av. Párroco Pablo Díez, 49-57 24010, León
Croatian: LABORATORIOS SYVA, S.A. Av. Párroco Pablo Díez, 49-57 24010, León
English: Austria Vana GmbH Wolfgang Schmälzl Gasse 6 1020 Wien
Croatian: Austrija Vana GmbH Wolfgang Schmälzl Gasse 6 1020 Wien
English: The scope of referral procedures is limited to evaluation of quality, safety and efficacy of veterinary medicinal products.
Croatian: Predmet postupaka upućivanja ograničen je na ocjenu kvalitete, sigurnosti i djelotvornosti medicinskoveterinarskih proizvoda.
English: Furthermore, higher approved doses (e.g. Genta Equine 10% solution for injection) may pose a threat to target animal safety due to the known nephrotoxicity of gentamicin.
Croatian: Nadalje, veće odobrene doze (primjerice Genta Equine 10% otopina za injekciju) mogu predstavljati prijetnju sigurnosti ciljnih životinja uslijed poznate nefrotoksičnosti gentamicina.
English: Croatia PROPHARMA VET d.o.o.
Croatian: Hrvatska PROPHARMA VET d.o.o. Vijenac A.
English: The reference product is Gentaject 10% solution for injection for horses which has been authorised in Ireland since 1988 (VPA 10976/2/1; Franklin Pharmaceuticals Ltd).
Croatian: Referenti VMP je Gentaject 10% otopina za injekciju za konje koja je odobrena u Irskoj od 1988. (VPA 10976/2/1; Franklin Pharmaceuticals Ltd).
English: Spain B.BRAUN VETCARE, S.A. Crta.
Croatian: Španjolska B.BRAUN VETCARE, S.A. Crta.
English: As such, gentamicin has a narrow margin of safety.
Croatian: Kao takav, gentamicin ima vrlo usko ograničenje sigurne primjene.
English: Referral procedures on the basis of Article 35 of Directive 2001/82/EC require a clearly formulated question referred to the Committee.
Croatian: Direktive 2001/82/EZ zahtijevaju jasno formulirano pitanje upućeno Odboru.
English: Ozzano Emilia (Bologna) Italy
Croatian: Ozzano Emilia (Bologna) Italija
English: To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid under- or over-dosing.
Croatian: Kako bi se osiguralo ispravno doziranje, tjelesnu težinu treba utvrditi što je preciznije moguće da bi se izbjeglo premalo ili prekomjerno doziranje.
English: The approved dosing regimens vary widely, ranging between doses of 2-10 mg/kg bw at intervals of 8-24 hours over 3-5 days.
Croatian: Odobreni režimi doziranja uvelike se razlikuju, i to u rasponu doza od 2 do 10 mg/kg tt u intervalima od 8 do 24 sata tijekom 3-5 dana.
English: Additionally, development of antimicrobial resistance towards gentamicin would present a serious risk both to human and animal health.
Croatian: Nadalje, razvoj antimikrobijske rezistencije na gentamicin predstavlja ozbiljan rizik kako za zdravlje ljudi tako i za zdravlje životinja.
English: Spain LABIANA LIFE SCIENCE, S.A. C/ Venus, 26
Croatian: Španjolska LABIANA LIFE SCIENCE, S.A. C/ Venus, 26
English: The substance is highly polar, hydrophilic and transport appears to be an active process closely linked to electron transport, oxidative phosphorylation and the respiratory quinones in the cell membrane.
Croatian: Tvar je izrazito polarna, hidrofilna, a čini se da je transport aktivan proces koji je usko povezan s transportom elektrona, oksidativnom fosforilacijom i respiratornim kvinoima u staničnoj membrani.
English: Therefore, on 14 February 2014, Denmark presented to the European Medicines Agency (‘the Agency') a referral notification under Article 35 of Directive 2001/82/EC, for all veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses.
Croatian: Stoga, 14. veljače 2014., Danska je dostavila Europskoj agenciji za lijekove (Agenciji) obavijest o postupku upućivanja u skladu sa člankom 35. Direktive 2001/82/EZ, za sve veterinarsko-medicinske proizvode koji sadrže gentamicin, a koji se primjenjuju kao injekcija za uporabu u konja.
English: C/ Prudenci Bertrana, 5 Polígono Industrial Agro-Reus Reus
Croatian: Španjolska POLICHEM S.L.U. C/ Prudenci Bertrana, 5 Polígono Industrial Agro-Reus Reus
English: Do not use in known cases of renal dysfunction.
Croatian: Ne koristite u poznatim slučajevima disfunkcije bubrega.
English: Where blood monitoring is available, target peak plasma gentamicin concentrations should be approximately 16-20 µg/ml.
Croatian: U slučaju kada je dostupno praćenje krvi, ciljne koncentracije gentamicina u plazmi trebaju iznositi otprilike 16-20 µg/ml.
English: • on the basis of the available data, the CVMP considered that all other indications and dosage regimens in horses should be deleted from the product information;
Croatian: • na osnovu dostupnih podataka, CVMP zaključio da se sve ostale indikacije i režimi doziranja u konja trebaju obrisati iz informacija o proizvodu;
English: As only very limited data are available to support all the current indications in horses the CVMP focused in their review mainly on the assessment of current scientific literature and minimum inhibitory concentration (MIC) data.
Croatian: Budući da su dostupni samo vrlo ograničeni podaci koji podržavaju sve aktualne indikacije u konja, CVMP se usredotočio u svojem pregledu uglavnom na ocjenu trenutne znanstvene literature i podataka o minimalnoj inhibitornoj koncentraciji (MIC-u).
English: Intravenous use.
Croatian: Intravenozna primjena.
English: During this MRP Denmark noted that the originator and the generic products have different indications and dosing regimens.
Croatian: Tijekom ovog MRP-a, Danska je istaknula kako izvorni VMP i generički VMP imaju različite indikacije i režime doziranja.
English: The marketing authorisations of the products concerned by this referral procedure are assumed to have been granted by the national competent authorities on the basis of Article 6(3) of Directive 2001/82/EC.
Croatian: Pretpostavljeno je da su odobrenja za stavljanje u promet VMP-ova koji su obuhvaćeni ovim postupkom upućivanja izdana od strane nacionalno nadležnih tijela na osnovu članka 6.(3) Direktive 2001/82/EZ.
English: In one mechanism, gentamicin can interfere with the correct amino acid polymerisation and elongation.
Croatian: U jednom mehanizmu, gentamicin može interefirati s pravilnom polimerizacijom amino kiseline i elongacije.
English: Spain LABORATORIOS SYVA, S.A.U.
Croatian: Španjolska LABORATORIOS SYVA, S.A.U.
English: Whenever possible, use of the product should be based on susceptibility testing of the bacteria isolated from the animal.
Croatian: Kada je to moguće, primjenu VMP-a treba temeljiti na testu podložnosti bakterija izoliranih iz životinja.
English: Latvia CP - Pharma Handelsges.
Croatian: CP - Pharma Handelsges.
English: Spain Industrial Veterinaria, S.A. Esmeralda, 19
Croatian: Španjolska Industrial Veterinaria, S.A. Esmeralda, 19
English: Enzymatic modification results in highlevel resistance.
Croatian: Enzimatična modifikacija rezultira rezistencijom velike razine.
English: Thus, the use of these products may present a serious risk to animal health in terms of lack of efficacy, as well as target animal safety.
Croatian: Stoga, primjena ovih VMP-ova može predstavljati ozbiljan rizik za zdravlje životinja u smislu nedostatka djelotvornosti kao i sigurnosti za ciljne životinje.
English: Whereas:
Croatian: Budući da je:
English: Belgium EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium
Croatian: Belgija EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgija
English: The product should therefore only be used based on the benefit-risk assessment by the responsible veterinary surgeon for each individual horse, taking into account alternative available treatment.
Croatian: VMP se stoga treba koristiti samo na temelju ocjene omjera koristi i rizika od strane odgovornog veterinarskog kirurga za svakog pojedinog konja, uzimajući u obzir dostupna alternativna liječenja.
English: However, studies in laboratory animals have shown evidence of fetal nephrotoxicity.
Croatian: No, ispitivanjima provedenima u laboratorijskih životinja utvrđena je fetalna nefrotoksičnost.
English: Spain SUPER´S DIANA, S.L Ctra.
Croatian: Španjolska SUPER´S DIANA, S.L Ctra.
English: A harmonised dosing regimen to be used in adult horses is proposed, that conforms to the desired PK/PD characteristics of a concentration-dependent antibiotic and reflects data available in horses.
Croatian: Predložen je usklađeni režim doziranja koji će se koristiti u odraslih konja, a koji je u skladu s željenim FK/FD značajkama antibiotika ovisnih o koncentraciji i reflektira podatke dostupne u konja.
English: The CVMP recommended a dosing regimen for adult horses of 6.6 mg/kg once daily for 3-5 days, accompanied by strong warnings in the product literature about the lack of target animal safety data.
Croatian: CVMP je preporučio režim doziranja za odrasle konje od 6,6 mg/kg jednom dnevno tijekom 3-5 dana, popraćeno strogim upozorenjima u literaturi proizvoda o nedostatku podataka o sigurnoj primjeni u ciljnih životinja.
English: Extra caution is advised if using gentamicin in old horses, or with fever, endotoxemia, sepsis and dehydration.
Croatian: Savjetuje se poseban oprez pri primjeni gentamicina u starijih konja, ili konja s groznicom, endotoksemijom, sepsom i dehidratacijom.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, applicants/marketing authorisation holders in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačina veterinarskomedicinskih proizvoda, životinjskih vrsti, podnositelja zahtjeva/nositelja odobrenja za stavljanje VMP-a u promet u državama članicama
English: However, foals, especially neonates, were recognised as significantly different from adult horses with regard to both an effective dosing regimen and target animal safety.
Croatian: No, prepoznato je da se ždrjebad, posebice neonatalna, značajno razlikuje od odraslih konja s obzirom na učinkovit režim doziranja i sigurnu primjenu u ciljnih životinja.
English: This leads to incorrect amino acid sequencing and nonsense proteins.
Croatian: Ovo rezultira nepravilnim sekvenciranjem aminokiseline i nonsense proteina.
English: Differences between neonatal foal kidneys and adults include a slower clearance of gentamicin in foals.
Croatian: Razlike između bubrega neonatalne ždrjebadi i odraslih životinja uključuju sporije čišćenje gentamicina u ždrjebadi.
English: Gentamicin sulphate is bactericidal in action by irreversibly binding to 30S ribosomal subunits, and acts through two different mechanisms.
Croatian: Gentamicin sulfat je baktericidan u djelovanju ireverzibilno se vezući na 30S ribosomalne podjedinice, te djeluje kroz dva različita mehanizma.
English: Warning sentences and advice for safe use have been included in the product information, which reflect the lack of target animal safety data in horses and foals.
Croatian: Rečenice koje sadrže upozorenja i savjete o sigurnoj primjeni uključene su u informacije o proizvodu, što reflektira nedostatak podataka o sigurnoj primjeni u ciljnih životinja, odnosno konja i ždrjebadi.
English: There are several mechanisms by which various strains of bacteria have developed resistance against aminoglycosides like gentamicin.
Croatian: Postoji nekoliko mehanizama kojima su različiti sojevi bakterija razvili rezistenciju na aminoglikozide poput gentamicina.
English: Single dose of 6.6 mg/kg body weight given intravenously once daily for 3-5 consecutive days.
Croatian: Jedna doza od 6,6 mg/kg tjelesne težine primjenjuje se intravenozno jednom dnevno tijekom 3-5 uzastopna dana.
English: The CVMP considered that this dose was supported by clinical experiences, taking into account that a single daily administration would reduce the risk of nephrotoxicity in adult horses (compared to more frequent daily administrations) and also the risk of the theoretical concept of adaptive resistance.
Croatian: CVMP je zaključio da je ova doza podržana kliničkim iskustvima, uzimajući u obzir da bi primjena jedne dnevne doze smanjila rizik od nefrotoksičnosti u odraslih konja (u usporedbi s učestalijim dnevnim primjenama) kao i rizik od teoretskog koncepta prilagodljive rezistencije.
English: The CVMP notes that there is no MRL for gentamicin for horses.
Croatian: CVMP je napomenuo da ne postoji MRL za gentamicin za primjenu u konja.
English: The CVMP Antimicrobials Working Party (AWP) and Efficacy Working Party (EWP) were consulted on several aspects of a safe dosing regimen of gentamicin in horses.
Croatian: Od antimikrobne radne skupine (AWP) i radne skupine o učikovitosti (EWP) CVMP-a zatraženi su savjeti o nekoliko aspekata režima sigurnog doziranja gentamicina u konja.
English: Gentamicin is primarily distributed within extracellular fluids.
Croatian: Gentamicin je primarno distribuiran unutar ekstrastaničnih tekućina.
English: Studies on the margin of safety of the currently approved dosing regimens were neither submitted by the MAHs nor could be identified in the scientific literature.
Croatian: Nositelji odobrenja nisu dostavili ispitivanja o granicama sigurne primjene aktualno odobrenih režima doziranja niti su iste mogle biti identificirane u znanstvenoj literaturi.
English: 4.1 Target species Horses (non food-producing horses).
Croatian: 4.1. Ciljne vrste Konji (konji koji se ne koriste za prehranu ljudi).
English: Gentamicin does not distribute to the cerebrospinal fluid.
Croatian: Gentamicin se ne distribuira u cerebrospinalnu tekućinu.
English: Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.
Croatian: Ne koristite u slučajevima poznate preosjetljivosti na djelatnu tvar ili na bilo koju pomoćnu tvar.
English: There are also isolated reports of ototoxicity with gentamicin.
Croatian: Postoje čak i izolirane prijave ototoksičnosti povezane s gentamicinom.
English: This monitoring includes assessing relevant kidney parameters in blood (e.g. creatinine and urea) and urinalysis (e.g. gamma glutamyl transferase/creatinine ratio).
Croatian: Ovakvo praćenje uključuje ocjenu relevantnih parametara funkcije bubrega u krvi (primjerice kreatinin i urea) i urinoanalizu (primjerice omjer gama glutamil transferaze/kreatinina).
English: In order to reduce the nephrotoxic risk, adequate hydration of animals under treatment should be ensured, and fluid therapy should be instituted, if required.
Croatian: Da bi se smanjio rizik od nefrotoksičnosti, potrebno je osigurati primjerenu hidrataciju životinja koje se podvrgavaju liječenju, te ako je potrebno treba započeti i terapiju tekućinom.
English: Gentamicin is well known to induce nephrotoxicity even at therapeutic doses.
Croatian: Poznato je da gentamicin inducira nefrotoksičnost čak i u terapijskim dozama.
English: In addition, there are only limited choices available for the treatment of Gram-negative infections in horses, and clinical experience has shown that gentamicin is effective in adult horses at a single daily dose of 6.6 mg/kg bw (intravenously) over 3-5 days.
Croatian: Nadalje, dostupan je samo ograničen izbor za liječenje gram-negativnih infekcija u konja, a kliničko je iskustvo pokazalo kako je gentamicin djelotvoran u odraslih konja u jednoj dnevnoj dozi od 6,6 mg/kg tt (intravenozno) tijekom 3-5 dana.
English: Constitución, 1 Planta baja 3 08960 Sant Just Desvern Barcelona
Croatian: Španjolska FATRO IBERICA, S.L. Constitución, 1 Planta baja 3 08960 Sant Just Desvern Barcelona
English: The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to harmonise the indication(s) and dosing regimens of the concerned products, taking into account the available data and in particular with regard to target animal safety.
Croatian: Od Odbora za veterinarsko-medicinske proizvode (CVMP) zatraženo je da uskladi indikaciju(e) i režime doziranja predmetnih VMP-ova, uzimajući u obzir dostupne podatke, a posebice u vezi sa sigurnom primjenom u ciljnih životinja.
English: Enzymatic modification is the most common type of aminoglycoside resistance.
Croatian: Enzimatična modifikacija je najčešći tip aminoglikozidne rezistencije.
English: Over-use of gentamicin products might result in an increased risk of the theoretical concept of adaptive resistance.
Croatian: Prekomjerna uporaba VMP-ova koji sadrže gentamicin može rezultirati povećanim rizikom od teorijskog koncepta adaptivne rezistencije.
English: Use of the product deviating from the instructions given in the SPC increases the risk of nephrotoxicity, and may increase the prevalence of bacteria resistant to gentamicin.
Croatian: Uporaba VMP-a koja odstupa od uputa navedenih u SPC-u povećava rizik od nefrotoksičnosti, te može povećati prevalenciju bakterija rezistentnih na gentamicin.
English: Calves, foals and piglets at the age of one month
Croatian: Goveda, ždrjebad i praščići u dobi od mjesec dana
English: In addition, gentamicin is known to be one of the most nephrotoxic aminoglycosides, with a very narrow margin of safety, which is of particular concern in young aninmals, i.e. foals.
Croatian: Nadalje, gentamicin je poznat kao jedan od najviše nefrotoksičnih aminoglikozida, s vrlo uskom marginom sigurne primjene, što je posebice razlog za zabrinutost u mladih životinja, primjerice ždrjebadi.