FrancophonIA/ELRC3.0 huggingface dataset:
English: Conjunctivitis, eye pain, abnormal vision, lacrimal gland disorder
Croatian: konjunktivitis, bol u oku, poremećaj vida, poremećaj suzne žlijezde
English: IntronA contains less than 1 mmol sodium (23 mg) per 3 mL, i.e., essentially "sodium-free".
Croatian: IntronA sadrži manje od 1 mmol natrija (23 mg) u 3 ml, tj. zanemarive količine natrija.
English: One vial of solution for injection or infusion contains 5 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 0.5 mL of solution.
Croatian: Jedna bočica otopine za injekciju ili infuziju sadrži 5 milijuna IU rekombinantnog interferona alfa-2b, proizvedenog na E. coli tehnologijom rekombinantne DNK, u 0,5 ml otopine.
English: irritability, chest pain, malaise Injection site pain Injection site necrosis, face oedema
Croatian: §, astenija, razdražljivost, bol u grudnom košu, malaksalost bol na mjestu injekcije nekroza na mjestu injekcije, edem lica
English: EU/1/99/127/047 12 multiple dose vial, 72 injection syringes with attached needle and needle protection device of 1 mL and 144 cleansing swabs
Croatian: EU/1/99/127/047 12 višedoznih bočica, 72 štrcaljke za injekciju s pričvršćenom iglom i uređajem za zaštitu igle od 1 ml i 144 tupfera za čišćenje
English: EU/1/99/127/044 12 multiple dose vials, 72 injection syringes of 1 mL, 72 injection needles and 144 cleansing swabs
Croatian: EU/1/99/127/044 12 višedoznih bočica, 72 štrcaljke za injekciju od 1 ml, 72 igle za injekciju i 144 tupfera za čišćenje
English: EU/1/99/127/042 12 multiple dose vials, 72 injection syringes of 1 mL, 72 injection needles and 144 cleansing swabs
Croatian: EU/1/99/127/042 12 višedoznih bočica, 72 štrcaljke za injekciju od 1 ml, 72 igle za injekciju i 144 tupfera za čišćenje
English: 1 single dose vial, 1 injection syringe of 2 mL, 1 injection needle and 1 cleansing swab 6 single dose vials, 6 injection syringes of 2 mL, 6 injection needles and 6 cleansing swabs 12 single dose vials, 12 injection syringes of 2 mL, 12 injection needles and 12 cleansing swabs
Croatian: 1 jednodozna bočica, 1 štrcaljka za injekciju od 2 ml, 1 igla za injekciju i 1 tupfer za čišćenje 6 jednodoznih bočica, 6 štrcaljki za injekciju od 2 ml, 6 igala za injekciju i 6 tupfera za čišćenje 12 jednodoznih bočica, 12 štrcaljki za injekciju od 2 ml, 12 igala za injekciju i 12 tupfera za čišćenje
English: Stomatitis ulcerative, right upper quadrant pain, glossitis, gingivitis, constipation, loose stools Pancreatitis, ischaemic colitis, ulcerative colitis, gingival bleeding
Croatian: mučnina/povraćanje, bol u abdomenu, dijarea, stomatitis, dispepsija ulcerativni stomatitis, bol u gornjem desnom kvadrantu, glositis, gingivitis, konstipacija, mekana stolica pankreatitis, ishemijski kolitis, ulcerativni kolitis, krvarenje iz desni poremećaji parodonta (nespecificirani), poremećaji zuba (nespecificirani)
English: EU/1/99/127/051 1 multiple dose vial, 6 injection syringes with attached needle of 1 mL and 12 cleansing swabs
Croatian: EU/1/99/127/051 1 višedozna bočica, 6 štrcaljki za injekciju s pričvršćenom iglom od 1 ml i 12 tupfera za čišćenje
English: 1 single dose vial, 1 injection syringe of 1 mL, 1 injection needle and 1 cleansing swab 6 single dose vials, 6 injection syringes of 1 mL, 6 injection needles and 6 cleansing swabs 12 single dose vials, 12 injection syringes of 1 mL, 12 injection needles and 12 cleansing swabs
Croatian: 1 jednodozna bočica, 1 štrcaljka za injekciju od 1 ml, 1 igla za injekciju i 1 tupfer za čišćenje 6 jednodoznih bočica, 6 štrcaljki za injekciju od 1 ml, 6 igala za injekciju i 6 tupfera za čišćenje 12 jednodoznih bočica, 12 štrcaljki za injekciju od 1 ml, 12 igala za injekciju i 12 tupfera za čišćenje
English: EU/1/99/127/016 1 single dose vial, 1 injection syringe of 1 mL, 1 injection needle and 1 cleansing swab
Croatian: EU/1/99/127/016 1 jednodozna bočica, 1 štrcaljka za injekciju od 1 ml, 1 igla za injekciju i 1 tupfer za čišćenje
English: EU/1/99/127/028 1 multiple dose vial, 6 injection syringes of 1 mL, 6 injection needles and 12 cleansing swabs
Croatian: EU/1/99/127/028 1 višedozna bočica, 6 štrcaljki za injekciju od 1 ml, 6 igala za injekciju i 12 tupfera za čišćenje
English: Ear and labyrinth Common:
Croatian: Poremećaji uha i labirinta često: vrlo rijetko:
English: Headache, dizziness
Croatian: Bolesti zuba i parodonta
English: EU/1/99/127/020 1 single dose vial, 1 injection syringe of 2 mL, 1 injection needle and 1 cleansing swab
Croatian: EU/1/99/127/020 1 jednodozna bočica, 1 štrcaljka za injekciju od 2 ml, 1 igla za injekciju i 1 tupfer za čišćenje
English: EU/1/99/127/018 12 single dose vials, 12 injection syringes of 1 mL, 12 injection needles and 12 cleansing swabs
Croatian: EU/1/99/127/018 12 jednodoznih bočica, 12 štrcaljki za injekciju od 1 ml, 12 igala za injekciju i 12 tupfera za čišćenje
English: EU/1/99/127/022 12 single dose vials, 12 injection syringes of 2 mL, 12 injection needles and 12 cleansing swabs
Croatian: EU/1/99/127/022 12 jednodoznih bočica, 12 štrcaljki za injekciju od 2 ml, 12 igala za injekciju i 12 tupfera za čišćenje
English: EU/1/99/127/048 1 multiple dose vial, 6 injection syringes with attached needle and needle protection device of 1 mL and 12 cleansing swabs
Croatian: EU/1/99/127/048 1 višedozna bočica, 6 štrcaljki za injekciju s pričvršćenom iglom i uređajem za zaštitu igle od 1 ml i 12 tupfera za čišćenje
English: IntronA 3 million IU/0.5 mL solution for injection or infusion interferon alfa-2b
Croatian: IntronA 3 milijuna IU/0,5 ml otopina za injekciju ili infuziju interferon alfa-2b
English: IntronA 5 million IU/0.5 mL solution for injection or infusion Interferon alfa-2b
Croatian: IntronA 5 milijuna IU/0,5 ml otopina za injekciju ili infuziju interferon alfa-2b
English: EU/1/99/127/014 12 single dose vials, 12 injection syringes of 1 mL, 12 injection needles and 12 cleansing swabs
Croatian: EU/1/99/127/014 12 jednodoznih bočica, 12 štrcaljki za injekciju od 1 ml, 12 igala za injekciju i 12 tupfera za čišćenje
English: EU/1/99/127/045 1 multiple dose vial, 6 injection syringes with attached needle and needle protection device of 1 mL and 12 cleansing swabs
Croatian: EU/1/99/127/045 1 višedozna bočica, 6 štrcaljki za injekciju s pričvršćenom iglom i uređajem za zaštitu igle od 1 ml i 12 tupfera za čišćenje
English: EU/1/99/127/017 6 single dose vials, 6 injection syringes of 1 mL, 6 injection needles and 6 cleansing swabs
Croatian: EU/1/99/127/017 6 jednodoznih bočica, 6 štrcaljki za injekciju od 1 ml, 6 igala za injekciju i 6 tupfera za čišćenje
English: Musculoskeletal and connective tissue disorders
Croatian: Odbacivanje presatka bubrega i jetre
English: EU/1/99/127/052 2 multiple dose vial, 12 injection syringes with attached needle of 1 mL and 24 cleansing swabs
Croatian: EU/1/99/127/052 2 višedozne bočice, 12 štrcaljki za injekciju s pričvršćenom iglom od 1 ml i 24 tupfera za čišćenje
English: EU/1/99/127/013 6 single dose vials, 6 injection syringes of 1 mL, 6 injection needles and 6 cleansing swabs
Croatian: EU/1/99/127/013 6 jednodoznih bočica, 6 štrcaljki za injekciju od 1 ml, 6 igala za injekciju i 6 tupfera za čišćenje
English: EU/1/99/127/021 6 single dose vials, 6 injection syringes of 2 mL, 6 injection needles and 6 cleansing swabs
Croatian: EU/1/99/127/021 6 jednodoznih bočica, 6 štrcaljki za injekciju od 2 ml, 6 igala za injekciju i 6 tupfera za čišćenje
English: EU/1/99/127/049 2 multiple dose vial, 12 injection syringes with attached needle and needle protection device of 1 mL and 24 cleansing swabs
Croatian: EU/1/99/127/049 2 višedozne bočice, 12 štrcaljki za injekciju s pričvršćenom iglom i uređajem za zaštitu igle od 1 ml i 24 tupfera za čišćenje
English: - One mL of solution contains 10 million IU of interferon alfa-2b
Croatian: - Jedan ml otopine sadrži 10 milijuna IU interferona alfa-2b.
English: Maintenance treatment: 10 million IU/m 2, 3 times a week (every other day) injected subcutaneously (under the skin).
Croatian: Terapija održavanja: 10 milijuna IU/m 2, triput na tjedan (svaki drugi dan)
English: EU/1/99/127/012 1 single dose vial, 1 injection syringe of 1 mL, 1 injection needle and 1 cleansing swab
Croatian: EU/1/99/127/012 1 jednodozna bočica, 1 štrcaljka za injekciju od 1 ml, 1 igla za injekciju i 1 tupfer za čišćenje
English: Subcutaneous use:
Croatian: Potkožna primjena:
English: EU/1/99/127/046 2 multiple dose vial, 12 injection syringes with attached needle and needle protection device of 1 mL and 24 cleansing swabs
Croatian: EU/1/99/127/046 2 višedozne bočice, 12 štrcaljki za injekciju s pričvršćenom iglom i uređajem za zaštitu igle od 1 ml i 24 tupfera za čišćenje
English: EU/1/99/127/043 2 multiple dose vials, 12 injection syringes of 1 mL, 12 injection needles and 24 cleansing swabs
Croatian: EU/1/99/127/043 2 višedozne bočice, 12 štrcaljki za injekciju od 1 ml, 12 igala za injekciju i 24 tupfera za čišćenje
English: EU/1/99/127/024 1 multiple dose vial 6 injection syringes of 1 mL, 6 injection needles and 12 cleansing swabs
Croatian: EU/1/99/127/024 1 višedozna bočica, 6 štrcaljki za injekciju od 1 ml, 6 igala za injekciju i 12 tupfera za čišćenje
English: - The active substance is recombinant interferon alfa-2b Each vial contains 18 million IU in 3 mL of solution.
Croatian: Kao uvodna terapija interferon alfa-2b se primjenjuje intravenski u dozi od 20 milijuna IU/m2 na dan,
English: IntronA is supplied as: - Pack of 1 vial - Pack of 1 vial, 6 injection syringes of 1 mL, 6 injection needles and 12 cleansing swabs - Pack of 1 vial, 6 injection syringes with attached needle and needle protection device of 1 mL
Croatian: IntronA je dostupan kao: - pakiranje sa 1 bočicom - pakiranje sa 1 bočicom, 1 štrcaljkom za injekciju od 1 ml, 1 iglom za injekciju i 1 tupferom za čišćenje - pakiranje sa 6 bočica, 6 štrcaljki za injekciju od 1 ml, 6 igala za injekciju i 6 tupfera za čišćenje - pakiranje sa 12 bočica, 12 štrcaljki za injekciju od 1 ml, 12 igala za injekciju i 12 tupfera za čišćenje
English: EU/1/99/127/041 2 multiple dose vials, 12 injection syringes of 1 mL, 12 injection needles and 24 cleansing swabs
Croatian: EU/1/99/127/041 2 višedozne bočice, 12 štrcaljki za injekciju od 1 ml, 12 igala za injekciju i 24 tupfera za čišćenje
English: - if you have psoriasis, it may get worse during treatment with IntronA.
Croatian: - ako imate cirozu ili druge tegobe s jetrom (osim hepatitisa B ili C). - ako imate psorijazu, bolest se može pogoršati tijekom liječenja lijekom IntronA. - dok uzimate IntronA možete privremeno imati povećan rizik od razvoja infekcije.
English: Important information about some of the ingredients of IntronA This medicinal product contains less than 1 mmol sodium (23 mg) per 2.5 mL, i.e., essentially "sodium-free".
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) u 2,5 ml, tj. zanemarive količine natrija.
English: Important information about some of the ingredients of IntronA This medicinal product contains less than 1 mmol sodium (23 mg) per 1 mL, i.e., essentially "sodiumfree".
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) u 1 ml, tj. zanemarive količine natrija.
English: Important information about some of the ingredients of IntronA This medicinal product contains less than 1 mmol sodium (23 mg) per 3 mL, i.e., essentially "sodiumfree".
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) u 3 ml, tj. zanemarive količine natrija.
English: Pack of 1 vial, 1 injection syringe of 1 mL, 1 injection needle and 1 cleansing swab Pack of 6 vials, 6 injection syringes of 1 mL, 6 injection needles and 6 cleansing swabs Pack of 12 vials, 12 injection syringes of 1 mL, 12 injection needles and 12 cleansing swabs Not all pack sizes may be marketed.
Croatian: - pakiranje sa 1 bočicom, 1 štrcaljkom za injekciju od 1 ml, 1 iglom za injekciju i 1 tupferom za čišćenje - pakiranje sa 6 bočica, 6 štrcaljki za injekciju od 1 ml, 6 igala za injekciju i 6 tupfera za čišćenje - pakiranje sa 12 bočica, 12 štrcaljki za injekciju od 1 ml, 12 igala za injekciju i 12 tupfera za čišćenje
English: Important information about some of the ingredients of IntronA This medicinal product contains less than 1 mmol sodium (23 mg) per 0.5 mL, i.e., essentially "sodium-free".
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) u 0,5 ml, tj. zanemarive količine natrija.
English: EU/1/99/127/050 12 multiple dose vial, 72 injection syringes with attached needle and needle protection device of 1 mL and 144 cleansing swabs EU/1/99/127/053 12 multiple dose vial, 72 injection syringes with attached needle of 1 mL and 144 cleansing swabs
Croatian: EU/1/99/127/050 12 višedoznih bočica, 72 štrcaljke za injekciju s pričvršćenom iglom i uređajem za zaštitu igle od 1 ml i 144 tupfera za čišćenje
English: The efficacy of IntronA is enhanced when given in combination with ribavirin.
Croatian: Bolesnici koji prethodno nisu bili liječeni (odrasli) Djelotvornost lijeka IntronA pojačava se kada se daje u kombinaciji s ribavirinom.
English: The Commission Decision C(2014)5053 was issued on 11 July 2014.
Croatian: Odluka Komisije C(2014)5053 izdana je 11. srpnja 2014.
English: The results are favourable but the treatment was metaphylactic.
Croatian: Rezultati su povoljni, no liječenje je bilo metafilaktičko.
English: Special warnings for each target species:
Croatian: Posebna upozorenja za svaku ciljanu vrstu:
English: Animals must not be slaughtered for human consumption during treatment.
Croatian: Životinje se ne smiju klati za ljudsku hranu tijekom liječenja.
English: Following a referral procedure (EMEA/V/A/088)
Croatian: Nakon postupka upućivanja (EMEA/V/A/088)
English: This is however difficult to interpret in terms of field efficacy since this study was based on an experimental infection model.
Croatian: Međutim, to je teško tumačiti u smislu učinkovitosti na terenu jer se ispitivanje temeljilo na eksperimentalnom modelu infekcije.
English: The treatment durations were unclear but were probably of several weeks.
Croatian: Trajanje tih liječenja nije jasno navedeno, no vjerojatno je riječ o liječenjima u trajanju od nekoliko tjedana.
English: Some of the strains might be naturally resistant.
Croatian: Neki od sojeva mogu biti prirodno rezistentni.
English: The recommended dosage rates are:
Croatian: Preporučene stope doziranja su:
English: Add, to all products and delete the existing text: 5.1 Pharmacodynamic properties
Croatian: Za sve proizvode potrebno je dodati i obrisati postojeći tekst: 5.1 Farmakodinamička svojstva
English: Zavet AD Ul.
Croatian: Zavet AD
English: Via Emilia, 285 40064 Ozzano Emilia (BO) Italy
Croatian: Via Emilia, 285 40064 Ozzano Emilia (BO)
English: Powder for use in drinking water or milk
Croatian: Prašak za primjenu u vodi za piće ili u mlijeku
English: Messogeion Ave 15451 Neo Psychiko Athens
Croatian: 15451 Neo Psychiko Athens
English: This CVMP decision should also be taken into account in the present referral procedure.
Croatian: U trenutačnom postupku upućivanja također treba uzeti u obzir odluku CVMP-a.
English: Add, to all products: 4.4 Special warnings for each target species
Croatian: Za sve proizvode potrebno je dodati: 4.4 Posebna upozorenja za svaku ciljanu vrstu
English: The data available do not allow the establishment of a clear time pattern for the evolution of MICs.
Croatian: Dostupni podatci ne omogućuju utvrđivanje jasnog vremenskog uzorka za evoluciju MIK-ova.
English: Pigs: To be completed nationally.
Croatian: Svinje: Ispunjava se na nacionalnoj razini.
English: It is likely that at the beginning, the product was developed and used in the same manner as a growth promoter and to prevent mortality and performance loss.
Croatian: Proizvod je u početku vjerojatno razvijan i primjenjivan na isti način kao poticatelj rasta te za prevenciju smrtnosti i gubitka izvedbe.
English: Andrew Street London, EC4A 3AE United Kingdom
Croatian: London, EC4A 3AE United Kingdom
English: In those trials, it seems that the treatment is used for prevention in a non-specific manner, maybe even as a growth promoter.
Croatian: Čini se da je u tim ispitivanjima liječenje primjenjivano radi prevencije na nespecifičan način, možda čak i za poticanje rasta.
English: Moreover, product use in such conditions is associated with a risk of further resistance selection or co-selection.
Croatian: Štoviše, primjena proizvoda u takvim uvjetima povezana je s rizikom od daljnjeg odabira ili suodabira rezistencije.
English: 49377 Vechta
Croatian: 49377 Vechta Germany
English: Bacteria were frequently re-isolated in the treated animals and in the case of E. coli, the reduction in the percentage of positive animals is not statistically significant.
Croatian: Bakterije su se često nanovo izolirale u liječenih životinja, a u slučaju E. coli smanjenje postotka broja životinja pozitivnih na bakteriju nije statistički značajno.
English: Thus the overall benefit-risk balance for such product formulations is considered negative.
Croatian: Stoga se ukupni omjer koristi i rizika za takve formulacije proizvoda smatra negativnim.
English: No firm clinical breakpoint could be proposed which would allow the prediction of clinical efficacy in the presence of poorly susceptible isolates, which currently represent the majority of isolates.
Croatian: Ne može se predložiti čvrsta klinička točka prijeloma koja bi omogućila predviđanje kliničke djelotvornosti u prisutnosti slabo osjetljivih izolata koji trenutačno predstavljaju većinu izolata.
English: In those bacterial species there is no evidence of an important resistant population or of an evolving resistance status.
Croatian: U slučaju tih bakterijskih vrsta ne postoje dokazi o bitnoj rezistentnoj populaciji ili statusu razvijajuće rezistencije.
English: 25191 Lérida Spain
Croatian: 25191 Lérida
English: 4.1 Target species
Croatian: 4.1 Ciljane vrste
English: Most importantly, these studies are very old (they were conducted in the context of the development and marketing of the combination more than 40 years ago) and the in vitro susceptibility of the B. hyodysenteriae strains is unknown.
Croatian: Što je najvažnije od svega, ta su ispitivanja vrlo stara (provedena su u kontekstu razvoja i promicanja primjene ove kombinacije prije više od 40 godina), a podatci o in vitro osjetljivosti sojeva bakterije B. hyodysenteriae nisu poznati.
English: nv Hoge Mauw 900 2370 Arendonk Belgium
Croatian: V.M.D. nv Hoge Mauw 900 2370 Arendonk Belgium
English: Pfizer Animal Health MA EEIG
Croatian: Rumunjska Pfizer Animal Health MA EEIG
English: Chickens: To be completed nationally.
Croatian: Pilići: Ispunjava se na nacionalnoj razini.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, and marketing authorisation holders in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačina veterinarskomedicinskih proizvoda, vrsta životinja, putova primjene i nositelja odobrenja za stavljanje u promet u državama članicama
English: Podružnica Zagreb za promidžbu Petra Hektorovića 2 10000 Zagreb Croatia
Croatian: Petra Hektorovića 2 10000 Zagreb Croatia
English: A series of old field studies, which investigated the impact of a systematic treatment on the zootechnical performances of flocks in comparison to a positive control, are also presented.
Croatian: Predočen je i niz starih terenskih ispitivanja u okviru kojih se ispitivao učinak sustavnog liječenja na zootehničke izvedbe jata u usporedbi s pozitivnom kontrolom.
English: Therefore, on 5 May 2015, Belgium initiated a procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry.
Croatian: Belgija je stoga 5. svibnja 2015. pokrenula postupak u skladu s člankom 35. Direktive 2001/82/EZ za veterinarsko-medicinske proizvode koji sadrže kombinaciju linkomicina i spektinomicina za peroralnu primjenu u svinja i/ili peradi.
English: 3, although the two situations are not directly comparable since the MIC values for tylosin are, overall, higher, and the doses used and pharmacokinetics may also differ.
Croatian: 3 iako navedene dvije situacije nisu izravno usporedive jer su vrijednosti MIK-a za tilozin, ukupno gledajući veće, a mogu se razlikovati i doze koje se upotrebljavaju u farmakokinetici.
English: D-10785 Berlin
Croatian: D-10785 Berlin Germany
English: 1902 Paiania Attiki Greece
Croatian: 2 Km Paiania-Spata Av 1902 Paiania Attiki Greece
English: Lincomycin-Spectinomycin 1,1% "Animed Service"Pulver zum Eingeben für Schweine
Croatian: Spectinomycin 1,1% "Animed Service"Pulver zum Eingeben für Schweine
English: The associated aetiology of B. hyodysenteriae and its role in pathogenesis is however not fully clear and no bacteriological follow-up has been performed in those studies.
Croatian: Međutim, povezana etiologija bakterije B. hyodysenteriae i njezina uloga u patogenezi nisu potpuni jasni i u tim ispitivanjima nije provedeno naknadno bakteriološko praćenje.
English: TARGET SPECIES
Croatian: CILJANE VRSTE
English: 24192 León Spain
Croatian: 24192 León
English: Those data indicate that strains with some level of MIC increase might nevertheless be effectively treated, leading to a favourable clinical outcome.
Croatian: Ti podatci pokazuju da se sojevi s određenom razinom povećanja MIK-a mogu svejedno učinkovito liječiti što dovodi do povoljnog kliničkog ishoda.
English: Although doses are only expressed as levels in water, it can be estimated that the optimal doses range from 75 to 300 mg combined actives/kg bw.
Croatian: Iako su doze prikazane samo kao razine u vodi, može se procijeniti da su optimalne doze u rasponu od 75 do 300 mg kombiniranih djelatnih tvari po kilogramu tjelesne težine.
English: For similar reasons, i.e. because of high in vitro resistance rates, in 2014, in the context of a referral procedure (EMEA/V/A/100)
Croatian: Zbog sličnih razloga, odnosno zbog visokih stopa in vitro rezistencije, CVMP je 2014., u kontekstu postupka upućivanja (EMEA/V/A/100)
English: The indication against swine dysentery caused by B. hyodysenteriae, can no longer be maintained and should be removed.
Croatian: Indikacija protiv svinjske dizenterije uzrokovane bakterijom B. hyodysenteriae više nije održiva i treba je ukloniti.
English: From the available information it appears that the resistance rates in the target bacteria are relatively low, and there is no indication of an evolving status.
Croatian: Na temelju dostupnih informacija čini se da su stope rezistencije ciljanih bakterija razmjerno niske te da ne postoji indikacija statusa evoluiranja.
English: Therefore, most available clinical data do not take into account the current status of in vitro susceptibility/resistance of the concerned bacterial species.
Croatian: Stoga se u većini dostupnih kliničkih podataka ne uzima u obzir trenutačno stanje u pogledu in vitro osjetljivosti/rezistentnosti bakterijskih vrsta o kojima je riječ.
English: Therefore there is no need to change the currently approved withdrawal periods for the products under assessment.
Croatian: Stoga nije potrebno mijenjati trenutačno odobrena razdoblja karencije za proizvode koji su u postupku procjene.
English: SPC warnings informing the user about that resistance status are not considered sufficient to mitigate that risk, notably because of the absence of interpretive criteria and standardised methods for susceptibility testing.
Croatian: Upozorenja u sažetku opisa svojstava kojima se korisnika obavješćuje o statusu u pogledu rezistencije ne smatraju se dovoljnima za ublažavanje rizika, osobito zbog nedostatka interpretativnih kriterija i standardiziranih metoda za ispitivanje osjetljivosti.
English: Where the following target species have already been approved, the wording below relating to the relevant species should be used:
Croatian: Ako su sljedeće ciljane vrste već odobrene, potrebno je upotrijebiti tekst u nastavku koji se odnosi na odgovarajuću vrstu: