FrancophonIA/ELRC3.0 huggingface dataset:
English: • When the medicine is given by mouth, it can be given either as tablets or a liquid, but the dose needed when using the tablets (how much and how often) is different from the one needed when using the liquid.
Croatian: • Ako se lijek uzima kroz usta, može se uzimati u obliku tableta ili kao tekućina, ali se potrebna doza kada se lijek uzima u obliku tablete (po količini i učestalosti) razlikuje od doze potrebne kada se lijek uzima kao tekućina.
English: • The usual dose of tablets is three tablets (300 mg) twice a day on the first day, then 300 mg once a day.
Croatian: • Uobičajena je doza tableta tri tablete (od 300 mg) dvaput na dan prvog dana, a zatim 300 mg jedanput na dan.
English: It is also used in patients with weakened immune systems (such as transplant patients) to treat thrush (fungal infection of the throat or mouth due to Candida) or prevent invasive fungal infections.
Croatian: Primjenjuje se i u bolesnika s oslabljenim imunosnim sustavom (kao što su bolesnici koji su bili podvrgnuti transplantaciji) za liječenje oralne kandidijaze (gljivična infekcija grla ili usta koju uzrokuje gljivica Candida) ili za prevenciju invazivnih gljivičnih infekcija.
English: It is available as a solution for infusion (drip) into a vein, but also as tablets and oral suspension for use by mouth.
Croatian: Dostupan je kao otopina za intravensku infuziju (drip), ali i u obliku tableta i oralne suspenzije za primjenu kroz usta.
English: • Noxafil is a medicine used to treat serious infections caused by fungi, when other medicines cannot be used or are not effective.
Croatian: • Noxafil je lijek za liječenje teških infekcija uzrokovanih gljivicama koji se primjenjuje ako su drugi lijekovi neprimjenjivi ili nedjelotvorni.
English: Doses of the liquid (200 mg, one 5-ml spoonful) are taken three or four times a day.
Croatian: Doze lijeka u obliku tekućine (200 mg u jednoj žlici od 5 ml) uzimaju se tri ili četiri puta na dan.
English: Product information for Noxafil (posaconazole) is to be updated to strengthen warnings that the two dose forms given by mouth cannot be simply interchanged at the same dose.
Croatian: Informacije o proizvodu za lijek Noxafil (posakonazol) potrebno je ažurirati kako bi se navela dodatna upozorenja o tome da se dva farmaceutska oblika lijeka koja se primjenjuju kroz usta ne mogu međusobno zamijeniti u istoj dozi.
English: The recommended oral dosage is 300 mg once a day with the tablets (after a loading dose of 300 mg twice daily on day 1) and 200 mg three to four times a day (600 to 800 mg daily) with the oral suspension.
Croatian: Preporučena je oralna doza od 300 mg jedanput na dan za tablete (nakon početne doze od 300 mg koja se uzima dvaput na dan prvog dana) te 200 mg tri ili četiri puta na dan (600 do 800 mg na dan) za oralnu suspenziju.
English: The product information is therefore to be updated to strengthen existing warnings that the two forms cannot be simply interchanged, and the packaging will also be changed to distinguish the two forms more clearly and to carry a warning statement that they should not be substituted for one another without adjusting the dose.
Croatian: Stoga je potrebno ažurirati informacije o proizvodu kako bi se navela dodatna upozorenja o tome da dva oblika ovog lijeka nisu međusobno zamjenjiva, a planira se i promjena ambalaže lijeka kako bi se ta dva oblika jasnije razlikovala i kako bi se dodalo upozorenje o tome da se jedan oblik lijeka ne može primjenjivati umjesto drugoga bez prilagodbe doze.
English: • Noxafil tablets and oral suspension are not interchangeable due to the differences between these two formulations in the frequency of dosing, administration with food and plasma drug concentration achieved.
Croatian: • Tablete Noxafil i oralna suspenzija Noxafil nisu međusobno zamjenjive jer se te dvije formulacije razlikuju s obzirom na učestalost doziranja, mogućnost primjene uz hranu i postignutu koncentraciju plazme u lijeku.
English: • Patients should not switch between taking Noxafil tablets and Noxafil oral suspension without talking to their doctor or pharmacist first as it may result in a decreased effectiveness or an increased risk of side effects.
Croatian: Noxafil oralnom suspenzijom Noxafil, ili obratno, a da prethodno o tome ne razgovaraju s liječnikom ili ljekarnikom jer to može rezultirati smanjenom djelotvornošću lijeka ili povećanim rizikom od nuspojava.
English: Prescribers are advised to make clear which form is intended when they write a prescription, and pharmacists should ensure that the correct form is dispensed.
Croatian: Liječnicima koji propisuju ovaj lijek savjetuje se da u receptu jasno naznače koji oblik lijeka propisuju, a ljekarnici trebaju voditi računa o tome da bolesniku ne daju pogrešan oblik lijeka.
English: Some patients have mistakenly received oral solution instead of tablets, leading to underdosing and to a potential lack of effect.
Croatian: Neki su bolesnici pogreškom primili oralnu suspenziju umjesto tableta, što je dovelo do uzimanja nedovoljnih doza i moguće neučinkovitosti lijeka.
English: Similarly, there are reports of patients given tablets instead of oral solution, leading to overdosage and side effects.
Croatian: Isto tako, zabilježeno je da su neki bolesnici primili tablete umjesto oralne suspenzije, što je dovelo do predoziranja i pojave nuspojava.
English: • The SmPC and patient information leaflet for Noxafil are being updated to strengthen warnings about the differences between the two formulations, and the outer cartons will be revised to further differentiate the two and to include a warning statement that they cannot be simply substituted without adjusting the dose.
Croatian: • Sažetak opisa svojstava lijeka i upute o lijeku za bolesnike za lijek Noxafil trenutačno se ažuriraju kako bi se navela dodatna upozorenja o razlikama između tih dviju formulacija, a revidirat će se i vanjska ambalaža lijeka kako bi se dodatno naznačile te razlike i uključilo upozorenje o tome da jedna formulacija ne može samo tako zamijeniti drugu bez prilagodbe doze.
English: • Medication errors have been reported following erroneous switching, resulting in over- or underdosage and consequent dose-related toxicity or lack of efficacy.
Croatian: • Zabilježeni su slučajevi pogrešnog uzimanja lijeka zbog zamjene oblika lijekova, što je rezultiralo predoziranjem ili nedovoljnim dozama i toksičnošću povezanom s primljenom dozom ili nedjelovanjem lijeka.
English: • There have been cases where patients were provided with the wrong form of the medicine, and so took the wrong dose, resulting either in side effects or in the medicine not being effective.
Croatian: • Zabilježeni su slučajevi davanja pogrešnog oblika lijeka bolesnicima koji su stoga primili pogrešnu dozu, što je rezultiralo pojavom nuspojava ili nedjelovanjem lijeka.
English: • It is important that the dosage form as well as the relevant dose be specified on the prescription, and that pharmacists ensure the correct oral dosage form is dispensed.
Croatian: • Važno je da se u receptu naznače farmaceutski oblik i odgovarajuća doza te da ljekarnici vode računa o tome da bolesnicima daju ispravan farmaceutski oblik lijeka koji se daje kroz usta.
English: Avoid contact with skin or eyes.
Croatian: Izbjegavajte kontakt s kožom ili očima.
English: These reactions will resolve within a maximum of 23 days.
Croatian: Te reakcije prolaze unutar najviše 23 dana.
English: ATCvet code: QJ01DD90.
Croatian: ATCvet kod: QJ01DD90.
English: In the event of contact, wash with clean water.
Croatian: Ako dođe do kontakta, isperite ih čistom vodom.
English: To ensure a correct dosage, bodyweight should be accurately determined to avoid under-dosing.
Croatian: Da bi se osigurala pravilna doza, tjelesnu težinu treba precizno utvrditi kako bi se izbjeglo poddoziranje.
English: If clinical signs have not improved 48 hours after treatment, the diagnosis and treatment of the condition should be re-evaluated.
Croatian: Ako se klinički znakovi ne poboljšaju 48 sati nakon liječenja, treba ponovo razmotriti dijagnozu i liječenje stanja.
English: Opaque white to light brown suspension.
Croatian: Neprozirna bijela do svijetlo smeđa suspenzija.
English: Resolution has been observed at 56 days post-injection.
Croatian: Povlačenje je primijećeno 56 dana nakon injekcije.
English: Whenever possible, cephalosporins should only be used based on susceptibility testing.
Croatian: Kada god je to moguće, cefalosporine treba upotrebljavati samo na temelju testiranja osjetljivosti.
English: Take appropriate precautions to avoid intra-arterial or intravenous injection.
Croatian: Poduzmite odgovarajuće mjere opreza da biste izbjegli intraarterijsko ili intravensko ubrizgavanje.
English: Sum of all residues retaining the betalactam structure expressed as desfuroylceftiofur
Croatian: Zbroj svih rezidua koji zadržavaju betalaktam ske strukture izražene kao desfuroilceftiofur
English: Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
Croatian: Primjenu proizvoda treba temeljiti na testiranju osjetljivosti, a u obzir treba uzeti službenu i lokalnu antimikrobnu politiku.
English: Date of first authorisation: 08/10/2009.
Croatian: Datum prvog odobrenja: 08/10/2009.
English: The active substance in Naxcel is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Croatian: Djelatne tvari u Naxcelu navedene se u tablici 1 dodatka Uredbe Komisije (EU) br. 37/2010 kako slijedi:
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Croatian: Pomoćne tvari navedene u odjeljku 6.1 Sažetka svojstava proizvoda dopuštene su tvari za koje je u tablici 1 dodatka Uredbe Komisije (EU) br. 37/2010 naznačeno da određivanje MRL-a nije nužno, odnosno, smatra se da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u ovom veterinarsko-medicinskom proizvodu.
English: Lactation: This veterinary medicinal product can be used during lactation.
Croatian: Laktacija: Ovaj veterinarsko-medicinski proizvod može se primjenjivati tijekom laktacije.
English: • Hold the syringe and insert the needle behind the animal's ear so the needle and syringe point in the direction of an imaginary line that would pass through the head toward the animal's opposite eye (see
Croatian: • Držite štrcaljku i uvedite iglu iza uške životinje kako bi igla i štrcaljka bile usmjerene u smjeru zamišljene crte koja bi prolazila kroz glavu prema suprotnom oku (vidi sliku 2).
English: Approximately 60% and 15% of the dose are excreted in the urine and faeces, respectively, within 10 days after administration.
Croatian: Približno 60% i 15% doze izlučuje se u urinu, odnosno u fekalijama, u roku od 10 dana nakon primjene.
English: Bordetella bronchiseptica is inherently insensitive to ceftiofur in vitro.
Croatian: Bordetella bronchiseptica je inherentno neosjetljiva na ceftiofur in vitro.
English: Visible swellings have been noted at the injection site in about two thirds of treated animals, two days after injection in field conditions.
Croatian: Na mjestu ubrizgavanja uočene su vidljive otekline kod otprilike dvije trećine liječenih životinja dva dana nakon ubrizgavanja u terenskim uvjetima.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Croatian: Budući da ne postoje studije kompatibilnosti, ovaj se veterinarsko-medicinski proizvod ne smije miješati s ostalim veterinarsko-medicinskim proizvodima.
English: No effects on the reproductive performance were observed in both species.
Croatian: Ni u jedne od tih dviju vrsta nije primijećen učinak na reproduktivne funkcije.
English: 1348 Louvain-la-Neuve
Croatian: 1348 Louvain-la-Neuve BELGIJA
English: In very rare cases, sudden death has been reported following administration of the product.
Croatian: U vrlo rijetkim slučajevima nakon primjene proizvoda prijavljena je iznenadna smrt.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi poslije “EXP”.
English: • Administer in the posterior part of the ear base (see Figure 1).
Croatian: • Primijeniti u stražnjem dijelu baze uške (vidi sliku 1).
English: It is recommended to limit injection volumes to a maximum of 4 ml.
Croatian: Preporučuje se ograničiti količinu za ubrizgavanje na maksimalno 4 ml.
English: Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa.
Croatian: Preosjetljivost na peniciline može dovesti do križnih reakcija na cefalosporine i obrnuto.
English: Injection site swellings may result in mild to moderate pain in some animals in the initial days following injection.
Croatian: Otekline na mjestu ubrizgavanja mogu uzrokovati od blage do umjerene boli u nekih životinja u prvim danima nakon ubrizgavanja.
English: Desfuroylceftiofur is the principal active metabolite.
Croatian: Desfuroilceftiofur je glavni aktivni metabolit.
English: Do not use as prophylaxis in case of retained placenta.
Croatian: Ne primjenjivati kao profilaksu u slučaju retencije posteljice.
English: In cattle, although Naxcel has not been specifically tested for overdoses, no signs of systemic toxicity related to ceftiofur have been observed following 55 mg/kg parenteral daily overdoses of ceftiofur sodium for five days.
Croatian: Kod goveda, iako Naxcel nije konkretno testiran na predoziranje, nisu primijećeni znakovi sustavne toksičnosti povezane s ceftiofurom nakon dnevnih predoziranja količinom od 55 mg/kg parenteralno ceftiofur-natrijem tijekom pet dana.
English: Do not store above 25 °C.
Croatian: Nemojte čuvati na temperaturi iznad 25 °C.
English: Pregnancy and fertility:
Croatian: Graviditet i plodnost:
English: Cattle.
Croatian: Goveda
English: It is recommended to limit injection volumes to a maximum of 30 ml per injection site.
Croatian: Preporučuje se ograničiti količinu za ubrizgavanje na maksimalno 30 ml po mjestu ubrizgavanja.
English: Protein binding of ceftiofur and its major metabolite is high, approximately 70% - 90%.
Croatian: Proteinsko vezanje ceftiofura i njegova glavnog metabolita visokih je vrijednosti, približno 70 - 90%.
English: Date of last renewal: 26/05/2010.
Croatian: Datum posljednjeg produljenja odobrenja: 26/05/2010.
English: • Take appropriate precautions to avoid intra-arterial or intravenous injection, such as restraining appropriately the animal (chute or head restraint for example) and using appropriate needles [1 inch (2.54 cm) long, 16 gauge].
Croatian: • Poduzmite odgovarajuće mjere opreza da biste izbjegli intraarterijsko ili intravensko ubrizgavanje, kao što su sputavanje životinje (kao npr. u stojnici ili fiksacija glave) i upotreba prikladne igle [2,54 cm x 1,3 mm].
English: Swelling of the face, lips or eyes or difficulty with breathing are serious reactions and require urgent medical attention.
Croatian: Oticanje lica, usnica ili očiju ili teškoće pri disanju ozbiljne su reakcije i zahtijevaju hitnu medicinsku pomoć.
English: Mild tissue reactions at the injection site, such as small areas (less than 6 cm²) of discolouration and small cysts have been observed for up to 42 days after injection.
Croatian: Blage reakcije tkiva na mjestu ubrizgavanja, kao što su mala područja gubitka boje (manja od 6 cm2) i male ciste, primijećeni su do 42 dana nakon ubrizgavanja.
English: After administration, ceftiofur is quickly metabolised to desfuroylceftiofur, the principal active metabolite.
Croatian: Nakon primjene ceftiofur se brzo metabolizira u desfuroilceftiofur, glavni aktivni metabolit.
English: Occasionally, transient local swelling may occur following intramuscular injection.
Croatian: Nakon intramuskularne injekcije povremeno se može pojaviti prolazna lokalna oteklina.
English: Protein binding of ceftiofur and its major metabolite is approximately 70%.
Croatian: Proteinsko vezanje ceftiofura i njegova glavnog metabolita iznosi približno 70%.
English: Laboratory studies in mice have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.
Croatian: Laboratorijske studije na miševima nisu dale nikakve dokaze teratogenog, fetotoksičnog ili maternotoksičnog djelovanja.
English: Maximum concentrations in plasma (4.2±0.9 µg/ml) are reached at approximately 22 hours after administration.
Croatian: Maksimalne koncentracije u plazmi (4,2 ± 0,9 µg/ml) dosegnu se približno 22 sata nakon primjene.
English: Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
Croatian: Oticanje lica, usnica ili očiju ili teškoće pri disanju ozbiljniji su simptomi i zahtijevaju hitnu medicinsku pomoć.
English: Official, national and regional antimicrobial policies should be taken into account when the product is used.
Croatian: Pri uporabi proizvoda u obzir treba uzeti službenu, nacionalnu i regionalnu antimikrobnu politiku.
English: Penicillins and cephalosporins such as ceftiofur may cause hypersensitivity in people and in animals following injection, inhalation, ingestion or skin contact.
Croatian: Penicilini i cefalosporini poput ceftiofura mogu uzrokovati preosjetljivost u ljudi i životinja nakon ubrizgavanja, udisanja, gutanja ili kontakta s kožom.
English: Treatment of acute interdigital necrobacillosis in cattle also known as Panaritium or foot rot.
Croatian: Liječenje akutne interdigitalne nekrobaciloze u goveda također poznate i kao panaricij ili zarazna šepavost.
English: Shake the bottle vigorously for 30 seconds, or until all visual settlement has been resuspended.
Croatian: Snažno tresite bočicu 30 sekundi ili dok se sav vidljivi talog ponovo ne rasprši u tekućini.
English: Pharmacotherapeutic group: Antibacterials for systemic use, third-generation cephalosporins.
Croatian: FARMAKOLOŠKA SVOJSTVA Farmakoterapijska grupa: Antibakterijska sredstva za sistemsku upotrebu , cefalosporini treće generacije.
English: Pasteurella multocida, Haemophilus parasuis and Streptococcus suis.
Croatian: Pasteurella multocida, Haemophilus parasuis i Streptococcus suis.
English: People with known hypersensitivity to penicillins and cephalosporins should avoid contact with this veterinary medicinal product.
Croatian: Osobe preosjetljive na peniciline i cefalosporine trebale bi u potpunosti izbjegavati kontakt s ovim veterinarsko-medicinskim proizvodom.
English: Ceftiofur is well absorbed in cattle following base of the ear injection.
Croatian: Ceftiofur se dobro apsorbira kod goveda nakon ubrizgavanja u bazu uške.
English: No studies have been conducted in pregnant or lactating sows, or in breeding pigs.
Croatian: Nisu provedene studije na gravidnim ili laktirajućim krmačama ili na rasplodnim svinjama.
English: Ceftiofur is a third generation cephalosporin antibiotic, which is active against many Gram-positive and Gram-negative pathogens.
Croatian: Ceftiofur je cefalosporinski antibiotik treće generacije koji djeluje na mnoge gram-pozitivne i gram negativne patogene.
English: Plasma concentrations above 0.2 µg/ml of ceftiofur and its metabolite are maintained for an appropriate period of time.
Croatian: Koncentracije u plazmi iznad 0,2 µg/ml ceftiofura i njegova metabolita održavaju se odgovarajuće vremensko razdoblje.
English: Meat and offal: 71 days.
Croatian: Meso i jestive iznutrice: 71 dan.
English: Owing to the low toxicity of ceftiofur in pigs overdoses do not typically lead to any clinical signs, other than transient local swellings as described in section 6 (Adverse reactions).
Croatian: Zbog niske toksičnosti ceftiofura u svinja predoziranje obično ne uzrokuje nikakve kliničke znakove, osim prolaznih lokalnih oteklina, kao što je opisano u odjeljku 6 (nuspojave).
English: Total plasma concentrations above 0.2µg/ml and 1µg/ml of ceftiofur and its active metabolites are maintained for at least 7 and 4 days, respectively.
Croatian: Ukupne koncentracije u plazmi iznad 0,2 mg/ml i 1 µg/ml ceftiofura i njegovih aktivnih metabolita održavaju se najmanje 7, odnosno 4 dana.
English: Maximum concentrations in plasma (about 5 µg/ml) occurred from 12 hours following administration.
Croatian: Maksimalne koncentracije u plazmi (oko 5 µg/ml) javljaju se počevši od 12 sati nakon primjene.
English: When considering the treatment strategy, it is appropriate to consider improvement of the herd management practice and use supporting treatment with suitable local products (e.g. disinfectants).
Croatian: Kada se razmatra strategija liječenja, uputno je razmotriti unapređenje upravljanja stadom u praksi i primjenu dodatnog liječenja odgovarajućim lokalnim proizvodima (npr. sredstvima za dezinfekciju).
English: Special precautions for use in animals:
Croatian: Posebna upozorenja za primjenu na životinjama:
English: Ceftiofur inhibits the bacterial cell wall synthesis, thereby exerting bactericidal properties.
Croatian: Ceftiofur inhibira sintezu bakterijske stanične stjenke, čime djeluje baktericidno.
English: Ceftiofur (as crystalline free acid)
Croatian: Ceftiofur (kao kristalinična slobodna kiselina)
English: It is essential that Naxcel is only administered subcutaneously at the base of ear location in non-edible tissue, as described in section 4.9, in order to comply with the meat withdrawal period.
Croatian: Bitno je da se Naxcel primjenjuje samo subkutano a u nejestivo tkivo baze uške, kao što je opisano u odjeljku 4.9, kako bi se primijenilo razdoblje karencije mesa.
English: If you develop symptoms following exposure such as a skin rash or persistent eye irritation, you should seek medical advice.
Croatian: Ako se nakon izlaganja pojave simptomi, na primjer osip na koži ili dugotrajna iritacija očiju, trebali biste potražiti savjet liječnika.
English: Treatment of acute interdigital necrobacillosis (Panaritium, foot rot).
Croatian: Liječenje akutne interdigitalne nekrobaciloze (panaricij, zarazna šepavost).
English: OTHER INFORMATION Naxcel is available in 50 ml or 100 ml vials.
Croatian: 15. OSTALE INFORMACIJE Naxcel je dostupan u bočicama od 50 ml ili 100 ml.
English: - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: OTHER INFORMATION Naxcel is available in 100 ml vials.
Croatian: 15. OSTALE INFORMACIJE Naxcel je dostupan u bočicama od 100 ml.
English: One hour after a single administration, plasma concentrations are above 1 µg/ml.
Croatian: Jedan sat nakon pojedinačne primjene koncentracije u plazmi budu iznad 1 µg/ml.
English: One hour after a single administration, plasma concentrations are greater than 1 µg/ml.
Croatian: Jedan sat nakon pojedinačne primjene koncentracije u plazmi budu veće od 1 µg/ml.
English: Ceftiofur is particularly active against the following target pathogens causing respiratory and other diseases in pigs: Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Streptococcus suis.
Croatian: Ceftiofur posebno dobro djeluje na sljedeće ciljne patogene koji uzrokuju bolesti dišnih putova i ostale bolesti u svinja: Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis i Streptococcus suis.
English: Treatment of acute post-partum (puerperal) metritis in cattle, in cases where treatment with another antimicrobial has failed.
Croatian: Liječenje akutnog postpartalnog (puerperalnog) metritisa u goveda u slučajevima kada liječenje drugim antimikrobnim sredstvima nije uspjelo.