FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of the strong CYP3A4 inducer rifampicin (600 mg daily for 31 days) to healthy volunteers increased cabozantinib clearance (4.3-fold) and decreased single-dose plasma cabozantinib exposure (AUC) by 77%.
Croatian: Primjena jakog induktora CYP3A4 rifampicina (600 mg dnevno tijekom 31 dana) u zdravih dobrovoljaca izazvala je povećanje klirensa kabozantiniba (za 4,3 puta) te smanjenje plazmatske izloženosti kabozantinibu
English: The other ingredients are: - Tablet contents: microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide anhydrous, magnesium stearate.
Croatian: - Sadržaj tablete: mikrokristalična celuloza; bezvodna laktoza; hidroksipropilceluloza; umrežena karmelozanatrij; koloidni, bezvodni silicijev dioksid; magnezijev stearat (pogledajte dio 2 za sadržaj laktoze)
English: MARKETING AUTHORISATION NUMBER(S) Cabometyx 20 mg film-coated tablets
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET CABOMETYX 20 mg filmom obložene tablete
English: CABOMETYX Placebo these therapies had to discontinue study treatment.
Croatian: Ispitanici koji su primali te terapije morali su prekinuti liječenje.
English: You should also use a barrier contraceptive (e.g. condom or diaphragm) whilst taking CABOMETYX and for at least 4 months after treatment has finished.
Croatian: Za vrijeme uzimanja CABOMETYXA i najmanje 4 mjeseca nakon završetka liječenja trebate također koristiti i mehanička kontraceptivna sredstva (npr. kondom ili dijafragmu).
English: CABOMETYX 40 mg film-coated tablets are yellow, triangle shaped with no score, and identified with “XL” on one side and “40” on the other side.
Croatian: CABOMETYX 40 mg filmom obložene tablete su žute, trokutastog oblika bez ureza, s oznakom “XL” s jedne strane i “40” s druge strane.
English: In the treatment-naïve RCC study (CABOSUN), the incidence of severe haemorrhagic events (Grade ≥ 3) was 5.1% (4/78) in cabozantinib-treated RCC patients.
Croatian: U ispitivanju prethodno neliječenog RCC-a (CABOSUN), incidencija teških hemoragijskih događaja (≥3 stupnja) u bolesnika s RCC-om liječenih kabozantinibom iznosila je 5,1 % (4/78).
English: CYP3A4 inducers and inhibitors Cabozantinib is a CYP3A4 substrate.
Croatian: Induktori i inhibitori CYP3A4
English: • Increase in amylase levels in the blood
Croatian: • Povišene razine amilaze u krvi
English: Method of administration CABOMETYX is for oral use.
Croatian: CABOMETYX je namijenjen za peroralnu primjenu.
English: This syndrome should be considered in any patient presenting with multiple symptoms, including seizures, headache, visual disturbances, confusion or altered mental function.
Croatian: glavobolju, poremećaje vida, konfuziju i promjenu mentalne funkcije.
English: CABOMETYX 60 mg film-coated tablets are yellow, oval shaped with no score, and identified with “XL” on one side and “60” on the other side.
Croatian: CABOMETYX 60 mg filmom obložene tablete su žute, ovalnog oblika bez ureza, s oznakom “XL” s jedne strane i “60” s druge strane.
English: CABOMETYX 20 mg film-coated tablets
Croatian: CABOMETYX 20 mg filmom obložene tablete
English: Cabozantinib was an inhibitor (IC50 = 7.0 μM), but not a substrate, of P-glycoprotein (P-gp) transport activities in a bi-directional assay system using MDCK-MDR1 cells.
Croatian: U sustavu za ispitivanje prolaska u oba smjera na MDCK-MDR1 stanicama kabozantinib se pokazao kao inhibitor (IC50 = 7,0 μM), ali ne i supstrat transportnog djelovanja P-glikoproteina (P-gp).
English: Excipient related warnings
Croatian: Upozorenja povezana s pomoćnim tvarima
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: Nositelj odobrenja za stavljanje lijeka u promet
English: The tablets are yellow round with no score, and debossed with “XL” on one side and “20” on the other side of the tablet.
Croatian: Tablete su žute boje, okrugle bez ureza, s utisnutim “XL” s jedne strane i “20” s druge strane tablete.
English: Figure 3: Kaplan Meier curve for progression-free survival by IRC in treatment-naïve RCC subjects
Croatian: Slika 3: Kaplan-Meierova krivulja preživljenja bez progresije bolesti u prethodno neliječenih ispitanika s RCC-om prema odboru za neovisnu radiološku procjenu
English: Table 3: Summary of PFS findings by independent radiology review committee in RCC subjects following prior vascular endothelial growth factor (VEGF)-targeted therapy (METEOR)
Croatian: Tablica 3: Prikaz rezultata PFS-a u ispitanika s RCC-om nakon prethodne terapije usmjerene na vaskularni endotelni faktor rasta (VEGF) prema odboru za neovisnu radiološku procjenu (METEOR)
English: General disorders and administration site conditions fatigue, mucosal inflammation, asthenia, peripheral oedema
Croatian: Opći poremećaji i reakcije na mjestu primjene umor, upala sluznice, astenija, periferni edem
English: Subjects receiving
Croatian: MATERIJALA KOJI POTJEČU
English: • Haemorrhoids (piles)
Croatian: • Upala gušterače
English: Centralpharma Communications OÜ Ipsen Poland Sp. z o.o.
Croatian: Ipsen Poland Sp. z o.o. Al. Jana Pawła II 29
English: How to take CABOMETYX 4.
Croatian: 3. Kako uzimati CABOMETYX
English: Cabozantinib treatment should be discontinued in patients with RPLS.
Croatian: U bolesnika s RPLS-om liječenje kabozantinibom se mora prekinuti.
English: Progression-free survival (PFS)3 Median PFS in months (95% CI) HR (95% CI)1 p-value1
Croatian: Preživljenje bez progresije bolesti (PFS)3 Medijan PFS-a u mjesecima (95 % CI) 5,2 (4,0; 5,5) HR (95 % CI) 1 p-vrijednost1
English: CABOMETYX 60 mg film-coated tablets: Each tablet contains cabozantinib (S)-malate equivalent to 60 mg of cabozantinib.
Croatian: CABOMETYX 60 mg filmom obložene tablete: jedna tableta sadrži kabozantinib (S)-malat u količini koja odgovara 60 mg kabozantiniba.
English: Closer monitoring is advised in patients with mild or moderate hepatic impairment.
Croatian: Preporučuje se pažljivo praćenje bolesnika s blagim do umjerenim oštećenjem funkcije jetre.
English: CABOMETYX 20 mg film-coated tablets Each film-coated tablet contains cabozantinib (S)-malate equivalent to 20 mg cabozantinib.
Croatian: CABOMETYX 20 mg filmom obložene tablete Jedna filmom obložena tableta sadrži kabozantinib (S)-malat u količini koja odgovara 20 mg kabozantiniba.
English: Cabozantinib was an inhibitor (IC50 = 7.0 μM), but not a substrate, of P-gp transport activities in a bi-directional assay system using MDCK-MDR1 cells.
Croatian: U sustavu za ispitivanje prolaska u oba smjera na MDCK-MDR1 stanicama kabozantinib se pokazao kao inhibitor (IC50 = 7,0 μM), ali ne i supstrat transportnog djelovanja P-gp-a.
English: CABOMETYX 60 mg film-coated tablets
Croatian: CABOMETYX 60 mg filmom obložene tablete
English: CABOMETYX 40 mg film-coated tablets: Each tablet contains cabozantinib (S)-malate equivalent to 40 mg of cabozantinib.
Croatian: CABOMETYX 40 mg filmom obložene tablete: jedna tableta sadrži kabozantinib (S)-malat u količini koja odgovara 40 mg kabozantiniba.
English: The tablets are yellow oval shaped with no score, and debossed with “XL” on one side and “60” on the other side of the tablet.
Croatian: Tablete su žute boje, ovalnog oblika bez ureza, s utisnutim “XL” s jedne strane i “60” s druge strane tablete.
English: Fatal perforations have occurred in the cabozantinib clinical program.
Croatian: U kliničkom programu primjene kabozantiniba bilo je pojave smrtonosnih perforacija.
English: The tablets are yellow triangle shaped with no score, and debossed with “XL” on one side and “40” on the other side of the tablet.
Croatian: Tablete su žute boje, trokutastog oblika bez ureza, s utisnutim “XL” s jedne strane i “40” s druge strane tablete.
English: CABOMETYX 40 mg film-coated tablets
Croatian: CABOMETYX 40 mg filmom obložene tablete
English: CABOMETYX 60 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU CABOMETYX 60 mg
English: Fatal haemorrhages have occurred in the cabozantinib clinical program.
Croatian: U kliničkom programu primjene kabozantiniba bilo je pojave smrtonosnih fistula.
English: In the HCC study (CELESTIAL), hepatic encephalopathy was reported more frequently in the cabozantinib than the placebo arm. Cabozantinib has been associated with diarrhoea, vomiting, decreased appetite and electrolyte abnormalities.
Croatian: U ispitivanju HCC-a (CELESTIAL), hepatična encefalopatija prijavljena je češće u skupini koja je primala kabozantinib nego u skupini koja je primala placebo.
English: CABOMETYX 20 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU CABOMETYX 20 mg
English: NAME OF THE MEDICINAL PRODUCT CABOMETYX 20 mg film-coated tablets cabozantinib STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains cabozantinib (S)-malate equivalent to 20 mg of cabozantinib.
Croatian: NAZIV LIJEKA CABOMETYX 20 mg filmom obložene tablete kabozantinib NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži kabozantinib (S)-malat u količini koja odgovara 20 mg kabozantiniba.
English: NAME OF THE MEDICINAL PRODUCT CABOMETYX 20 mg film-coated tablets cabozantinib
Croatian: NAZIV LIJEKA CABOMETYX 20 mg filmom obložene tablete kabozantinib NAZIV NOSITELJA
English: • Increase in lipase levels in the blood
Croatian: • Povišene razine lipaze u krvi
English: Film-coated tablet 28 film-coated tablets 30 film-coated tablets
Croatian: OBLIK I SADRŽAJ Filmom obložena tableta 28 filmom obloženih tableta 30 filmom obloženih tableta NAČIN I PUT(EVI) PRIMJENE LIJEKA Primjena kroz usta
English: Bucureşti, 010623
Croatian: Bucureşti, 010623 Tel: + 40 (021) 231 27 20
English: Each film-coated tablet contains cabozantinib (S)-malate equivalent to 40 mg cabozantinib.
Croatian: Jedna filmom obložena tableta sadrži kabozantinib (S)-malat u količini koja odgovara 40 mg kabozantiniba.
English: Each film-coated tablet contains cabozantinib (S)-malate equivalent to 60 mg cabozantinib.
Croatian: Jedna filmom obložena tableta sadrži kabozantinib (S)-malat u količini koja odgovara 60 mg kabozantiniba.
English: NAME OF THE MEDICINAL PRODUCT CABOMETYX 60 mg film-coated tablets cabozantinib
Croatian: NAZIV LIJEKA CABOMETYX 60 mg filmom obložene tablete kabozantinib NAZIV NOSITELJA
English: CABOMETYX 20 mg film-coated tablets: Each tablet contains cabozantinib (S)-malate equivalent to 20 mg of cabozantinib.
Croatian: CABOMETYX 20 mg filmom obložene tablete: jedna tableta sadrži kabozantinib (S)-malat u količini koja odgovara 20 mg kabozantiniba.
English: Overall Survival Median OS in months (95% CI)
Croatian: Ukupno preživljenje (OS) Medijan OS-a (95% CI), mjeseci
English: Table 4: Summary of ORR findings per independent radiology committee review (IRC) and investigator review, in RCC subjects following prior vascular endothelial growth factor (VEGF)-targeted therapy
Croatian: Tablica 4: Prikaz rezultata ORR-a u ispitanika s RCC-om nakon prethodne terapije usmjerene na vaskularni endotelni faktor rasta (VEGF) prema odboru za neovisnu radiološku procjenu (engl.
English: Progression-free survival (PFS) by Investigator Median PFS in months (95% CI) HR (95% CI); stratified b,c Two-sided log-rank p-value: stratified b p=0.0042
Croatian: Preživljenje bez progresije bolesti (PFS) prema ispitivaču Medijan PFS-a (95% CI), mjeseci HR (95% CI); stratificirani b,c
English: Progression-free survival (PFS) by IRC a Median PFS in months (95% CI) HR (95% CI); stratified b,c Two-sided log-rank p-value: stratified b p=0.0005
Croatian: Preživljenje bez progresije bolesti (PFS) prema IRC-u a Medijan PFS-a (95% CI), mjeseci HR (95% CI); stratificiran b,c
English: NAME OF THE MEDICINAL PRODUCT CABOMETYX 40 mg film-coated tablets cabozantinib
Croatian: NAZIV LIJEKA CABOMETYX 40 mg filmom obložene tablete kabozantinib NAZIV NOSITELJA
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON NAME OF THE MEDICINAL PRODUCT CABOMETYX 40 mg film-coated tablets cabozantinib STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains cabozantinib (S)-malate equivalent to 40 mg of cabozantinib.
Croatian: NAZIV LIJEKA CABOMETYX 40 mg filmom obložene tablete kabozantinib NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži kabozantinib (S)-malat u količini koja odgovara 40 mg kabozantiniba.
English: • Increase in level of potassium in the blood
Croatian: • Povišena razina kalija u krvi
English: CABOMETYX 40 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU CABOMETYX 40 mg
English: • Bone damage in the jaw
Croatian: • Oštećenje kosti čeljusti
English: España
Croatian: Francuska
English: CABOMETYX Placebo
Croatian: CABOMETYX
English: • Swelling in your legs and arms
Croatian: • Oticanje ruku i nogu
English: Hepatic encephalopathy hepatitis cholestatic
Croatian: Poremećaji jetre i žuči hepatična encefalopatija kolestatski hepatitis
English: Cabozantinib should be restarted with a lower dose when PPES has been resolved to grade 1.
Croatian: Kada se PPES povuče do 1. stupnja, primjena kabozantiniba mora se nastaviti sa smanjenom dozom.
English: Cabozantinib should be discontinued in patients who experience a GI perforation or a fistula that cannot be adequately managed.
Croatian: U bolesnika u kojih se pojavi GI perforacija ili fistula koja se ne može odgovarajuće zbrinuti mora se prekinuti primjena kabozantiniba.
English: Endpoint
Croatian: Placebo
English: Cabozantinib should be discontinued in patients who develop nephrotic syndrome.
Croatian: U bolesnika u kojih se razvije nefrotski sindrom primjena kabozantiniba se mora prekinuti.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Croatian: Populacija s namjerom liječenja (ITT)
English: (see section 2 for lactose content) - Film coating: hypromellose, titanium dioxide (E171), triacetin, iron oxide yellow (E172) What CABOMETYX looks like and contents of the pack CABOMETYX 20 mg film-coated tablets are yellow, round with no score, and identified with “XL” on one side and “20” on the other side.
Croatian: - Film-ovojnica: hipromeloza; titanijev dioksid (E171); triacetin; željezov oksid, žuti (E172)
English: Member State EU/EEA
Croatian: Država Članica EU/EEA
English: ATCvet code: QJ01MA90.
Croatian: ATCvet kod: QJ01MA90.
English: The main areas of disharmony in the existing product information relate to:
Croatian: Glavna područja neusuglašenosti u postojećim informacijama za proizvod su:
English: Bayer BV Energieweg 1
Croatian: Nizozemska Bayer BV Energieweg 1
English: Discussion of data available
Croatian: Razmatranje dostupnih podataka
English: Do not eat, drink or smoke whilst handling the product.
Croatian: Ne jesti, piti ili pušiti tijekom rukovanja s VMP-om.
English: Do not use in cats less than 8 weeks of age.
Croatian: Ne primjenjivati mačkama mlađim od 8 tjedana.
English: Because the safety and the efficiency of the product have not been assessed in cats less than 8 weeks, the contraindication in such animals is justified.
Croatian: Budući da djelotvornost i sigurnost proizvoda nije ocijenjena u mačaka mlađih od 8 tjedana, opravdane su kontraindikacije u takvih životinja.
English: Viale Certosa, 130 20156 Milano Italy
Croatian: Viale Certosa, 130 20156 Milano Italija
English: Wash hands after use.
Croatian: Nakon primjene treba oprati ruke.
English: If accidental self-injection occurs seek medical advice immediately.
Croatian: U slučaju nehotičnog samoinjiciranja odmah treba zatražiti savjet liječnika.
English: The local tolerance was followed during tolerance and/or clinical studies in pigs, calves and dogs.
Croatian: Lokalna tolerancija uslijedila je tijekom ispitivanja tolerancije i/ili kliničkih ispitivanja u svinja, goveda i pasa.
English: In dogs, a moderate and transient local reaction (such as oedema) may occur.
Croatian: U pasa se može očitovati umjerena i prolazna lokalna reakcija (kao što je edem).
English: During this referral and considering the scope of the procedure, adequate data have been submitted to support the following posology (depending on the indications):
Croatian: Tijekom ovog upućivanja i razmatrajući opseg postupka, dostavljeni su primjereni podaci u prilog sljedećih doziranja (ovisno o indikacijama):
English: <Date of first authorisation:> <{DD/MM/YYYY}><{DD month YYYY}.>
Croatian: Datum prvog odobrenja:> <{DD/MM/GGGG}> <{DD mjesec GGGG}.
English: 50 ml and 100 ml in a cardboard box.
Croatian: 50 mL i 100 mL u kartonskoj kutiji.
English: Do not use in young dogs during their growth, i.e. in small breeds of dogs less than 8 months of age, in big breeds of dogs less than 12 months of age, in giant breeds of dogs less than 18 months of age.
Croatian: Ne primjenjivati mladim psima u razdoblju rasta tj. malim pasminama pasa mlađim od 8 mjeseci, velikim pasminama pasa mlađim od 12 mjeseci i vrlo velikim pasminama pasa mlađim od 18 mjeseci.
English: Local reactions at injection site
Croatian: Lokalne reakcije na mjestu injekcije
English: No residue depletion data were made available.
Croatian: Nisu dostavljeni podaci o pražnjenu rezidua.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holders in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačina veterinarsko medicinskog proizvoda, životinjskih vrsta, putova primjene, nositelja odobrenja za stavljanje u promet u Državama
English: Do not use concurrently with theophylline as the elimination of theophylline may be delayed.
Croatian: Ne smije se primjenjivati istodobno s teofilinom jer eliminacija teofilina može biti usporena.
English: Concerning target species cattle and pigs a risk has been identified regarding an insufficient dose rate against target pathogens in cattle and pigs.
Croatian: Vezano uz ciljne vrste goveda i svinja, rizik je identificiran s obzirom na nedostatnu dozu protiv ciljnih patogena u goveda i svinja.
English: It has antibacterial activity against a broad spectrum of Gram-negative and Grampositive bacteria.
Croatian: Ima antibakterijsko djelovanje protiv širokog spektra gram pozitivnih i gram negativnih bakterija.
English: EXPIRY DATE EXP {month/year} Once broached use by …
Croatian: ROK VALJANOSTI EXP { mjesec/godina} Jednom otvoren upotrijebiti do…
English: Bayer Austria GmbH Herbststraße 6-10 1160 Wien Austria
Croatian: Bayer Austria GmbH Herbststraße 6-10 1160 Wien Austrija
English: In very rare cases intravenous treatment of cattle can cause shock reactions, presumably as a result of circulatory impairment.
Croatian: U vrlo rijetkim slučajevima primjena u venu kod goveda može uzrokovati šok reakcije, pretpostavlja se zbog poremećaja u cirkulaciji.
English: Warning sentences are sufficient to ensure the safe use of the product by the person who administers the product.
Croatian: Rečenice koje sadrže upozorenja dostatne su kako bi se osigurala sigurna primjena proizvoda od strane osoba koje primjenjuju proizvod.
English: Shelf life of the veterinary product as packaged for sale: 4 years.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 4 godine.
English: All mechanisms lead to a reduced susceptibility of the bacteria to fluoroquinolones.
Croatian: Svi mehanizmi dovode do smanjene osjetljivosti bakterija prema fluorokinolonima.
English: To be completed nationally.
Croatian: Popunjava se na nacionalnoj razini.
English: Then in countries where feeding of fallen stock to scavenger bird populations is permitted as a conservation measure special warnings have to be keep in order to reduce the risk for these birds.
Croatian: Nadalje, u državama u kojima je hranjenje populacije strvinara uginulom stokom dozvoljeno, potrebno je pridržavanje posebnih mjera upozorenja za očuvanje mesa kako bi se smanjio rizik za ove ptice.
English: In accidental overdose there is no antidote and treatment should be symptomatic.
Croatian: U slučaju nehotičnog predoziranja ne postoji antidot, a liječenje je simptomatsko.
English: In countries where feeding of fallen stock to scavenger bird populations is permitted as a conservation measure (see Commission Decision 2003/322/EC), the possible risk to hatching success should be considered before feeding carcasses of livestock recently treated with this product.
Croatian: U zemljama gdje je dopušteno hranjenje populacije ptica iz skupine strvinara na uginuloj stoci kao mjera očuvanja (vidi Odluku Komisije 2003/322/EZ), prije dozvole hranjenja na lešinama životinja tretiranih ovim VMP-om, treba uzeti u obzir mogući rizik za uspješnost leženja.
English: • the CVMP reviewed the summaries of product characteristics, labelling and package leaflets proposed by the marketing authorisation holders and considered all the overall submitted data;
Croatian: • je CVMP pregledao sažetke opisa svojstava VMP-a, etikete i uputa za uporabu predložene od strane nositelja odobrenja za stavljanje VMP-a u promet i razmotrio sve dostavljene podatke;
English: Care should be taken to avoid accidental self-injection.
Croatian: Potreban je oprez kako bi se izbjeglo slučajno samoinjiciranje.
English: 220 Avenue de la Recherche 59120 Loos
Croatian: Francuska Bayer Sante 220 Avenue de la Recherche 59120 Loos
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan mL otopine sadržava:
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Croatian: POSEBNO(A) UPOZORENJE(A), UKOLIKO JE POTREBNO Pročitati uputu o VMP-u prije primjene.
English: Although horses are not authorised as target species the Committee considered that a contraindication for use in growing horses should be included in the product information for the 50 mg/ml and 100 mg/ml strengths.
Croatian: Iako konji nisu odobrena ciljna vrsta, Povjerenstvo smatra da u informacije o proizvodu treba uvrstiti kontraindikaciju za jačine od 50 mg/ml i 100 mg/ml.
English: EXP {month/year} Once broached use within 28 days.
Croatian: EXP {mjesec/godina} Jednom otvoreno upotrijebiti u roku 28 dana.
English: They may persist at least up to 17 days after the injection.
Croatian: One mogu potrajati najmanje 17 dana nakon injekcije.
English: Taking into account the available data, the CVMP concluded that the poor bacteriological results obtained in vivo and the results from the PK/PD analysis do not sufficiently support this indication.
Croatian: Uzimajući u obzir dostupne podatke, CVMP je zaključio da slabi bakteriološki rezultati dobiveni in vivo i rezultati iz FK/FD analiza u dostatnoj mjeri ne podržavaju ovu indikaciju.
English: Avoid skin and eye contact.
Croatian: Treba izbjegavati dodir s kožom i očima.
English: Furthermore, it has to be considered that large differences exist in the pharmacokinetic behaviour of enrofloxacin among different species, which additionally will influence the decision about the correct dosage of “product name (to be completed nationally)”.
Croatian: Nadalje, mora se uzeti u obzir da velike razlike u farmakokinetici enrofloksacina postoje kod različitih vrsta, što će dodatno utjecati na odluku o ispravnom doziranju <Izmišljeno ime> otopine za injekciju.
English: Regarding E. coli, a PK/PD study was conducted at the proposed dose.
Croatian: U slučaju E. coli provedeno je FK/FD ispitivanje u predloženoj dozi.
English: The overall benefit-risk balance of the products was deemed positive subject to the recommended changes in the product information (see Annex III).
Croatian: Cjelokupan omjer koristi i rizika VMP-ova ocijenjen je pozitivnim, a predmetom je preporučenih izmjena u informacijama o proizvodu (vidjeti Dodatak III).
English: Depending on species, the safety of the veterinary medicinal product has been established through specific studies in pregnant and/or lactating animals (cows, sows).
Croatian: Ovisno o vrsti, sigurnost veterinarsko-medicinskog proizvoda utvrđena je pomoću specifičnih ispitivanja u gravidnih životinja i/ili životinja u laktaciji (krave, krmače).
English: Regarding Histophilus somni, only susceptibility data originated in Canada, USA and Europe were provided, showing the high susceptibility of the bacterium to enrofloxacin.
Croatian: U vezi sa Histophilus somni, dostavljeni su samo podaci o osjetljivosti koji potječu iz Kanade, SADa i Europe, te dokazuju visoku osjetljivost bakterije na enrofloksacin.