FrancophonIA/ELRC3.0 huggingface dataset:
English: Probenecid/Lamivudine
Croatian: URIKOZURICI probenecid/lamivudin
English: Rifampicin/Lamivudine
Croatian: ANTIMIKOBAKTERICI rifampicin/lamivudin
English: Phenytoin/Zidovudine
Croatian: fenitoin/zidovudin
English: Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 970070
Croatian: Österreich ratiopharm Arzneimittel Vertriebs-GmbH
English: Musculoskeletal and connective tissue disorders Common: Arthralgia, muscle disorders Rare: Rhabdomyolysis
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Često: artralgija, mišićni poremećaji
English: Then continue your treatment as before.
Croatian: Teva na isti način.
English: Zidovudine:
Croatian: Zidovudin:
English: Contents of the pack and other information What Lamivudine/Zidovudine Teva contains
Croatian: Što Lamivudin/Zidovudin Teva sadrži
English: Tel: +371 67323666
Croatian: Sicor Biotech filiāle Latvijā Tel: +371 67323666
English: Respiratory, thoracic and mediastinal disorders Uncommon: Dyspnoea
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja: Manje često: dispneja
English: Children weighing between 21 kg and 30 kg: the recommended oral dose of Lamivudine/Zidovudine Teva is one-half tablet taken in the morning and one whole tablet taken in the evening.
Croatian: Djeca s tjelesnom težinom između 21 kg i 30 kg: preporučena oralna doza Lamivudina/Zidovudina
English: Discussion of the data available
Croatian: Rasprava o dostupnim podacima
English: Milk: 13.5 days.
Croatian: Mlijeko: 13,5 dana.
English: The MIC distribution pattern has not changed notably during recent years.
Croatian: Uzorak distribucije MIK-a nije značajno promijenjen posljednjih godina.
English: Member State EU/EEA
Croatian: Država članica EU-a/EGP-a
English: 1107 Budapest Hungary
Croatian: 1107 Budapest Mađarska
English: A Piso 2 Parque Industrial e Comercial Serra das Minas
Croatian: Parque Industrial e Comercial Serra das Minas
English: This procedure is necessary so that individual injection sites are kept apart.
Croatian: Ovaj je postupak neophodan kako bi se pojedinačna mjesta injekcije držala odvojena.
English: Therefore, the risk of resistance development among these bacteria can presently not be fully evaluated.
Croatian: Stoga se rizik od razvoja rezistencije među ovim bakterijama trenutno ne može u cijelosti ocijeniti.
English: Antimicrobial resistance
Croatian: Antimikrobijska rezistencija
English: Via Vittor Pisani 16 20124 Milano Italy
Croatian: Via Vittor Pisani 16 20124 Milano Italija
English: If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Croatian: Ukoliko to nije moguće, terapiju treba temeljiti na lokalnim (regionalnim, na razini farme) epidemiološkim informacijama o osjetljivosti ciljnih bakterija.
English: The establishment of withdrawal periods was based on the better conducted and most reliable study.
Croatian: Procjena razdoblja karencije temeljila se na bolje provedenom i najpouzdanijem ispitivanju.
English: 4.1 Target species
Croatian: 4.1 Ciljne vrste
English: Quality, target animal safety, user safety and environmental risk were not assessed in this referral procedure.
Croatian: Kvaliteta, sigurnost ciljnih životinja, sigurnost korisnika i rizik za okoliš nisu procijenjeni u ovom postupku upućivanja.
English: Use of the product should be based on susceptibility testing of the bacteria isolated from the animal.
Croatian: Uporabu proizvoda treba temeljiti na testiranju osjetljivosti bakterija izoliranih iz životinje.
English: Spiramicin proved to be more efficacious and with a lower relapse rate compared to the positive controls.
Croatian: Dokazano je da je Spiramicin djelotvorniji i ima manju stopu relapsa u usporedbi s pozitivnim kontrolama.
English: If this means that the dose must be divided into two injections, then injections should be administered on opposite sides of the neck.
Croatian: Ako ovo znači da se doza mora podijeliti u dvije injekcije, injekcije treba primijeniti u suprotne strane vrata.
English: Other indications in cattle and all indications in pigs
Croatian: Druge indikacije u goveda i sve indikacije u svinja
English: Following intramuscular injection, spiramycin is rapidly absorbed and maximal plasma concentrations are reached within 3 hours.
Croatian: Nakon intramuskularne injekcije, spiramicin se brzo apsorbira, a maksimalne koncentracije plazme postižu se unutar 3 sata.
English: A limited resistant populaton was observed above 64 µg/ml.
Croatian: Uočena je ograničena rezistentna populacija pri dozi većoj od 64 µg/ml.
English: The following Minimum Inhibitory Concentrations (MIC) have been determined for spiramycin in European isolates collected from diseased animals between 2007 to 2012:
Croatian: Utvrđene su sljedeće minimalne inhibitorne koncentracije (MIK) za spiramicin u europskih izolata prikupljenih iz bolesnih životinja između 2007. i 2012.:
English: Cattle Mannheimia haemolytica Cattle
Croatian: Goveda Mannheimia haemolytica Goveda
English: Use of the product deviating from the instructions given in the product information may increase the prevalence of bacteria resistant to spiramycin.
Croatian: Uporaba proizvoda koja odstupa od uputa navedenih u informacijama o proizvodu može povećati prevalenciju bakterije koja je otporna na spiramicin.
English: It is assumed that compared to cattle the pharmacokinetic profile of spiramycin in calves would be similar or even more favourable.
Croatian: Pretpostavlja se da u usporedbi s profilom u goveda, farmakokinetički profil spiramicina u teladi bi bio sličan ili čak povoljniji.
English: 5.2 Pharmacokinetic particulars
Croatian: 5.2 Farmakokinetičke posebnosti
English: Special precautions for use in animals:
Croatian: Posebne mjere opreza u životinja:
English: Efficacy issues
Croatian: Pitanja djelotvornosti
English: However, in line with CVMP guideline on the conduct of bioequivalence studies in veterinary medicinal products (EMA/CVMP/016/00)3, product specific data are required to establish the residue depletion profile at the injection site.
Croatian: No, u skladu sa smjernicama CVMP-a o provođenju ispitivanja bioekvivaletnosti u veterinasko-medicinskih proizvoda (EMA/CVMP/016/00)3, neophodni su podaci specifični za proizvod kako bi se utvrdio profil razgradnje rezidua u mjestu injekcije.
English: The data were, however, not appropriate to support subclinical or chronic mastitis or mastitis caused by other bacteria like S. uberis.
Croatian: No podaci nisu bili primjereni kako bi se podržala indikacija subkliničkog ili kroničnog mastitisa ili mastitisa uzrokovanog drugim bakterijama poput S. uberis.
English: In a worst-case scenario a AUC/MIC-ratio of 100-125 hours as target for spiramycin has been proposed.
Croatian: U slučaju najgoreg scenarija, omjer AUC/MIK od 100-125 sati predložen je kao ciljana vrijednost za spiramicin.
English: • on the basis of the available data, the CVMP considered that indications as provided in Annex III
Croatian: • je na temelju dostupnih podataka, CVMP zaključio da su indikacije koje su navedene u Dodatku III
English: Regarding bovine mastitis pathogens such as S. aureus and S. uberis, there exists already a resistant proportion of strains, as evident from recent surveillance programs.
Croatian: Vezano uz patogene goveđeg mastitisa poput S. aureus i S. uberis, već postoji rezistentan dio sojeva, kao što je to vidljivo iz najnovijeg programa nadzora.
English: • on the on basis of the available data, the CVMP considered that all other indications and dosage regimens in cattle and all indications in pigs should be deleted from the product information;
Croatian: • je na temelju dostupnih podataka, CVMP zaključio da se sve druge indikacije i režimi doziranja u goveda i sve indikacije u svinja trebaju obrisati iz informacija o proizvodu;
English: The comparison of earlier with more recently determined MIC-data is, more over, complicated by the different laboratory methods used, and the fact that no break points validated for veterinary medicine exist.
Croatian: Usporedba ranijih s novije utvrđenim podacima za MIK jest, što više, otežana različitim primijenjenim laboratorijskim metodama, te činjenicom da ne postoje točke prekida potvrđene za veterinarsko-medicinske proizvode.
English: Spiramycin is weakly bound to plasma proteins.
Croatian: Spiramicin se slabo vezuje na proteine plazme.
English: Due to concerns related to efficacy, antimicrobial resistance and withdrawal periods, on 12 September 2012, Germany presented to the Agency a referral notification under Article 35 of Directive 2001/82/EC for Suanovil 20 and associated names, Captalin and associated names, and generic products thereof.
Croatian: Zbog zabrinutosti povezane s djelotvornosti, antimikrobijskom rezistencijom i razdobljima karencije, dana 12. rujna 2012., Njemačka je dostavila Agenciji obavijest o postupku upućivanja u skladu sa člankom 35. Direktive 2001/82/EZ za VMP-ove Suanovil 20 i povezane nazive, Captalin i povezane nazive, kao i generičke proizvode istih.
English: Belgium Merial Belgium SA Culliganlaan 1c
Croatian: Merial Belgium SA Culliganlaan 1c 1831 Diegem Belgija
English: Labelling:
Croatian: Etiketa:
English: Spiramycin levels in tissues and fluids were further increased when spiramycin was injected for a second time after 48 hours.
Croatian: Koncentracije spiramicina u tkivima i tekućinama povećavale su se nakon što je spiramicin ubrizgan po drugi puta nakon 48 sati.
English: Applicant/Marketing Authorisation Holder
Croatian: Podnositelj zahtjeva/nositelj odobrenja
English: were justified;
Croatian: opravdane;
English: In these studies the efficacy of spiramycin had been compared to negative controls or to other antibiotics approved for these indications (oxytetracycline and tylosin).
Croatian: U ovim ispitivanjima uspoređena je djelotvornost spiramicina s negativnim kontrolama ili s drugim antibioticima odobrenima za ove indikacije (oksitetraciklin i tilozin).
English: Spiramycin is a weak base, not ionized and liposoluble which crosses easily cellular membranes by passive diffusion.
Croatian: Spiramicin je slaba baza, nije ioniziran i liposolubilni, zbog čega lako prolazi kroz stanične membrane pasivnom difuzijom.
English: MIC of spiramycin (µg/mL) Range
Croatian: MIK spiramicina (µg/mL) Raspon
English: Rue de Bourgelat 17 69002 Lyon France
Croatian: Rue de Bourgelat 17 69002 Lyon Francuska
English: Respiratory infections:
Croatian: Infekcije dišnih putova:
English: Bacteria species
Croatian: Bakterijske vrste
English: Using the statistical analysis1 the residues depletion at the injection sites suggested a withdrawal period of 52 days.
Croatian: Primjenom statističke analize1, razgradnja rezidua u mjestima injekcije ukazuje na razdoblje ustezanja u trajanju od 52 dana.
English: Do not administer more than 20 ml per injection site.
Croatian: Ne primjenjujte više od 20 ml po mjestu injekcije.
English: 4.5 Special precautions for use Special precautions for use in animals
Croatian: 4.5 Posebne mjere opreza Posebne mjere opreza u životinja
English: Cattle.
Croatian: Goveda.
English: Despite of several limitations, in particular the small number of animals and the short (14 days) observation period, the study was found appropriate to justify the indication ‘acute S. aureus mastitis', since results in the primary end point (bacteriological cure was reached in 7 out of 8 test cows, but in none of the 9 control cows) and some of the secondary endpoints (particularly the somatic cell count) were convincing.
Croatian: Usprkos nekoliko ograničenja, posebice malog broja životinja i kratkog (14 dana) opservacijskog razdoblja, utvrđeno je da je ispitivanje primjereno kako bi opravdalo indikaciju „akutni mastitis S. aureus“, budući da su rezultati bili uvjerljivi u primarnoj završnoj točki (bakteriološko liječenje ostvareno je u 7 od 8 testnih krava, no niti u jednoj od 9 kontrolnih krava), te pojedine u sekundarnim završnim točkama (posebice broj somatskih stanica).
English: Ceva Sante Animale 10 avenue de la Ballastiere 33500 Libourne France
Croatian: Ceva Sante Animale 10 avenue de la Ballastiere 33500 Libourne Francuska
English: Rua Doutor António Loureiro Borges, 9/9A, 9ºA Miraflores 1495-131 Algés
Croatian: 9/9A, 9ºA Miraflores 1495-131 Algés Portugal
English: Earlier and more recent in vitro susceptibility data of the target pathogens had been derived from a large number of strains collected from cattle in several EU Member States.
Croatian: Stariji i noviji podaci o in vitro osjetljivosti ciljnih patogena izvedeni su iz velikog broja sojeva prikupljenih iz goveda u nekoliko država članica EU.
English: Consequently these indications/dosage regimens in cattle and target species pigs should be deleted from the product information.
Croatian: Slijedom toga, ove indikacije/ovi režimi doziranja u goveda i ciljnih vrsta svinja trebaju se obrisati iz informacija o proizvodu.
English: • on the basis of the available residue depletion data in cattle, the CVMP considered that withdrawal periods should be amended to provide assurance for consumer safety;
Croatian: • je na temelju dostupnih podataka o razgradnji rezidua u stoke, CVMP zaključio da se razdoblja karencije trebaju dopuniti kako bi se osigurala sigurnost potrošača;
English: La Ballastière 33500 Libourne France
Croatian: La Ballastière 33500 Libourne Francuska
English: Spiramycin is metabolised in the liver; its primary metabolite, neospiramycin, possesses antimicrobial activity.
Croatian: Spiramicin se metabolizira u jetri; njegov primaran metabolit, neospiramicin, posjeduje antimikrobno djelovanje.
English: While for S. aureus this fraction amounted to less than 10% of the strains examined, the tri-modal MIC-distribution pattern obtained for S. uberis indicated that in addition to the susceptible fraction 10% of the strains examined had intermediate susceptibility and 20% were resistant.
Croatian: Iako u slučaju S. aureus ovaj dio iznosi manje od 10% ispitanih sojeva, tri-modalni uzorci distribucije za MIK prikupljeni za S. uberis ukazuju da je osjetljivi dio od 10% ispitanih sojeva imao srednji stupanj osjetljivosti, a 20% je bilo rezistentno.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Croatian: DOZIRANJE ZA SVAKU VRSTU, PUT(EVI) I NAČIN PRIMJENE
English: Failure to follow these instructions may result in residues above the established maximum residue limit of 200 µg/kg for muscle.
Croatian: Ukoliko se ne pridržavate ovih uputa, može doći do nakupljanja rezidua iznad maksimalnog ograničenja za rezidue od 200 µg/kg za mišiće.
English: Do not administer more than 15 ml per injection site.
Croatian: Ne primjenjujte više od 15 ml po mjestu injekcije.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to give its opinion on the indications, dosing regimens and withdrawal periods in cattle and pigs, in order to ensure efficacious treatment and lower the risk of development of antimicrobial resistance to spiramycin taking into account the available data and also to harmonise the withdrawal periods in cattle and pigs for the concerned products.
Croatian: Od Odbora za veterinarsko-medicinske proizvode (CVMP) zatraženo je da donese svoje mišljenje o indikacijama, režimima doziranja i razdobljima karencije u goveda i svinja sa ciljem osiguravanja djelotvornog liječenja i smanjenja rizika od razvoja antimikrobijske rezistencije uzimajući u obzir dostupne podatke, te usklađivanje razdoblja karencije u goveda i svinja za predmetne proizvode.
English: Based on a residue depletion study performed in accordance with the current guidance2 for the determination of withdrawal periods for milk, a withdrawal period of 27 milkings (13.5 days) can be recommended for milk.
Croatian: Na temelju ispitivanja razgradnje rezidua provedenog u skladu s aktualnim smjernicama2 za utvrđivanje razdoblja karencije za mlijeko, razdoblje karencije od 27 mužnji (13,5 dana) može se preporučiti za mlijeko.
English: Mannheimia haemolytica Cattle Staphylococcus aureus
Croatian: Mannheimia haemolytica Goveda Staphylococcus aureus Goveda
English: Captalin solution for injection contains 31.25 g spiramycin per 100 ml, corresponding to 1 000 000 IU spiramycin per ml.
Croatian: Captalin otopina za injekciju sadrži 31,25 g spiramicina na 100 ml, što odgovara 1 000 000 IU spiramicina po ml.
English: Therefore, the benefit-risk balance is considered negative for these indications in cattle and all indications in pigs.
Croatian: Stoga se omjer koristi i rizika smatra negativnim za ove indikacije u goveda i za sve indikacije u svinja.
English: Data from clinical surveillance monitoring programs (VetPath I: 1997-2004, VetPath III: 2007-2012) show that a considerable proportion of bovine mastitis strains of S. aureus were susceptible to spiramycin in vitro, with MIC50 and MIC90 of 4 µg/ml and 8 µg/ml, respectively.
Croatian: Podaci iz programa praćenja kliničkog nadzora (VetPath I: 1997-2004, VetPath III: 2007-2012) potvrđuju da je značajan dio sojeva goveđeg mastitisa bakterije S. aureus bio osjetljiv na spiramicin in vitro, s vrijednostima MIC50 i MIC90 od 4 µg/ml odnosno 8 µg/ml.
English: Particularly high spiramycin concentrations were determined in lung macrophages.
Croatian: Posebno visoke koncentracije spiramicina utvrđene su u makrofagima pluća.
English: However, as Spirovet is bioequivalent to Suanovil 20 the same withdrawal period of 27 milkings (13.5 days) can be recommended.
Croatian: No, budući da je Spirovet bioekvivalent VMP-a Suanovil 20 isto razdoblje karencije od 27 mužnji (13,5 dana) može se preporučiti za mlijeko.
English: However since the assessment identified some deficiencies such as no surrounding injection site samples in adult cattle, it was considred necessary to use the alternative approach1 and add a 20% safety span.
Croatian: No, budući da je ocjenom identificirano nekoliko nedostataka, poput primjerice izostanak uzorka iz mjesta koja okružuju mjesto injekcije u odraslih goveda, smatrano je neophodnim primijeniti alternativan pristup1 i dodati sigurnosni raspon od 20%.
English: Using the statistical analysis the calculated withdrawal period for cattle meat and offal is 75 days.
Croatian: Primjenom statističke analize izračunata je karencija za goveđe meso i iznutrice u trajanju od 75 dana.
English: The overall benefit-risk balance of the products under this procedure was deemed positive subject to the recommended changes in the product information (see Annex III).
Croatian: Zaključeno je da je cjelokupan omjer koristi i rizika VMP-ova obuhvaćenih ovim postupkom pozitivan te da je predmetom izmjena informacija o proizvodu (vidjeti Dodatak III).
English: Lung levels determined following this treatment regime reached a multiple of the corresponding plasma levels from 4 hours after injection onwards and persisted on a high level for 32 hours after a single injection.
Croatian: Koncentracije u plućima utvrđene nakon ovog režima liječenja dosegnule su višestruke vrijednosti koncentracija plazme koje odgovaraju onima 4 sata nakon injekcije i održale su se na jednako visokoj razini do 32 sata nakon jedne injekcije.
English: Since the study has shortcomings (no data for tissues other than injection site and in some samples residues in the surrounding injection site were higher than in the core), it was considered necessary to use the alternative approach and add a 30% safety span which resulted in a withdrawal period of 68 days for cattle meat and offal.
Croatian: Budući da je ispitivanje imalo nedostataka (nisu dostavljeni nikakvi podaci za tkivo izuzev za mjesto injekcije, a u pojedinim uzorcima vrijednosti za rezidue prikupljene iz tkiva oko mjesta injekcije bile su veće nego u samom središtu), smatrano je neophodnim da se primjeni alternativan pristup te da se doda sigurnosni raspon od 30% koji je rezultirao razdobljem karencije od 68 dana za goveđe meso i iznutrice.
English: Spiramycin acts on bacterial protein synthesis by binding to the 50S ribosomal subunits, inhibiting the translocation step.
Croatian: Spiramicin djeluje na sintezu bakterijskih proteina vezujući se na ribosomalne podjedinice 50S, inhibirajući translokacijski korak.
English: The withdrawal periods for cattle meat and milk should be amended as proposed to provide assurance for consumer safety.
Croatian: Razdoblja karencije za goveđe meso i mlijeko treba dopuniti sukladno preporukama kako bi se osigurala sigurnost konzumenata.
English: 4.9 Amounts to be administered and administration route
Croatian: 4.9 Količine za primjenu i putovi primjene
English: Mastitis caused by S. aureus should be treated once clinical signs are observed.
Croatian: Mastitis uzrokovan bakterijom S. aureus treba liječiti čim se uoče klinički znakovi.
English: If more than two injections are needed, a distance of at least 15 cm should be maintained between injections given on the same side of the neck.
Croatian: Ako je potrebno više od dvije injekcije, potrebno je zadržati razmak od 15 cm između dvije injekcije koje se primjenjuju u istu stranu vrata.
English: Body weight should be determined as accurately as possible to avoid underdosing.
Croatian: Kako bi se izbjeglo predoziranje potrebno je utvrditi što je točnije moguće tjelesnu težinu.
English: Regarding bovine respiratory pathogens like Pasteurella multocida and Mannheimia haemolytica, in vitro MIC-values of spiramycin are generally high, but their mono-modal distribution pattern does not indicate a relevant resistant fraction.
Croatian: Vezano uz respiratorne patogene poput Pasteurella multocida i Mannheimia haemolytica, in vitro vrijednosti MIK za spiramicin su načelno visoke, no njihov mono-modalni uzorak raspodjele ne ukazuje na relevantnu rezistentnu frakciju.
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 za odobrenje za stavljanje VMP-a u promet/nositelja odobrenja za stavljanje VMP-a u promet u državama članicama
English: Lactating cows
Croatian: Krave u laktaciji
English: Spiramycin is active against Staphylococcus aureus, Mannheimia haemolytica and Pasteurella multocida.
Croatian: Spiramicin je djelotvoran protiv Staphylococcus aureus, Mannheimia haemolytica i Pasteurella multocida.
English: Its tissue distribution is extensive, with high concentration particularly in bronchial secretions, lung parenchyma, alveolar macrophages, udders and milk.
Croatian: Njegova distribucija u tkivu je opsežna, s visokim koncentracijama posebice u bronhijalnim sekrecijama, plućnim parenhimima, alveolarnim makrofagima, vimenima i mlijeku.
English: Meat and offal: 75 days.
Croatian: Meso i iznutrice: 75 dana.
English: Szállás u. 5
Croatian: A Piso 2
English: Overall summary of the scientific evaluation of Suanovil 20 and associated names, Captalin and associated names and generic products thereof (see Annex I)
Croatian: Cjelokupan sažetak znanstvene ocjene VMP-a Suanovil 20 i povezanih naziva, Captalin i povezanih naziva te generičkih VMP-ova istih(vidjeti Dodatak I)
English: Cattle (calves)
Croatian: Goveda (telad)
English: The veterinary medicinal products Suanovil 20 solution for injection and its generic product Spirovet are solutions for injection which contain 20 g spiramycin per 100 ml, corresponding to 600 000 IU spiramycin per ml.
Croatian: Veterinarski-medicinski proizvodi Suanovil 20 otopina za injekciju i njegov generički proizvod Spirovet su otopine za injekciju koje sadrže 20 g spiramicina na 100 ml, što odgovara 600 000 IU spiramicina po ml.
English: For the second dose (after 24 h or 48 h) the same practice should be followed, ensuring that a distance of at least 15 cm is maintained between all injections administered as part of the treatment.
Croatian: Za drugu dozu (nakon 24 sata ili 48 sati) treba primijeniti istu praksu, pri čemu je potrebno osigurati razmak od najmanje 15 cm između svih injekcija koje se primjenjuju kao dio liječenja.
English: Only acute cases of mastitis caused by S. aureus with clinical signs observed for less than 24 h should be treated.
Croatian: Trebaju se liječiti samo akutni znakovi mastitisa uzrokovanog S. aureus s kliničkim znakovima uočenima u manje od 24 sata.