FrancophonIA/ELRC3.0 huggingface dataset:
English: However treatment-emergent resistance to oseltamivir did not affect treatment response and caused no prolongation of influenza symptoms.
Croatian: Međutim, razvoj rezistencije na oseltamivir tijekom liječenja nije utjecao na odgovor na liječenje i nije uzrokovao produljenje simptoma gripe.
English: The primary efficacy parameter for all of these studies was the incidence of laboratory-confirmed influenza.
Croatian: Primarni pokazatelj djelotvornosti u svim je studijama bila incidencija laboratorijski potvrđene gripe.
English: Reversible irritancy of rabbits' eyes was detected.
Croatian: Reverzibilna iritacija očiju otkrivena je u kunića.
English: Insufficient data are available for infants who have a postconceptual age of less than 36 weeks.
Croatian: Nedostatni su podaci za dojenčad postkoncepcijske dobi manje od 36 tjedana.
English: Add a small amount - no more than one teaspoonful - of sweet food to the powder in the bowl.
Croatian: Dodajte malu količinu - ne više od jedne čajne žličice - slatke hrane u zdjelicu s prahom.
English: ARs are added to the appropriate category in the tables according to the pooled analysis from clinical studies.
Croatian: Nuspojave su uključene u odgovarajuću kategoriju na temelju grupne analize kliničkih studija.
English: 60 ml or 75 ml*
Croatian: 60 ml ili 75 ml*
English: Multiple-dose pharmacokinetics were studied in a small number of children enrolled in a clinical efficacy study.
Croatian: Višekratna doza ispitivala se na malom broju djece uključene u kliničko ispitivanje djelotvornosti.
English: Results from pharmacokinetic analyses indicate a lower exposure to the active metabolite, however dose adjustments are not recommended for pregnant women in the treatment or prophylaxis of influenza (see section 5.2, Pharmacokinetics, Special Population).
Croatian: Iako rezultati farmakokinetičkih analiza ukazuju na nižu razinu izloženosti aktivnom metabolitu, ne preporučuje se prilagođavati dozu za liječenje ili profilaksu gripe u trudnica (vidjeti dio 5.2 Farmakokinetika, 'Posebne populacije').
English: Add a small amount - no more than one teaspoonful - of a sweet food to the second bowl.
Croatian: Dodajte malu količinu - ne više od 1 čajne žličice - slatke hrane u drugu zdjelicu.
English: Influenza is associated with adverse pregnancy and foetal outcomes, with a risk of major congenital malformations, including congenital heart defects.
Croatian: Gripa je povezana sa štetnim ishodima za trudnoću i plod, uz rizik od značajnih urođenih malformacija, uključujući urođene srčane greške.
English: Administration of 100 mg oseltamivir phosphate twice daily for 5 days to patients with various degrees of renal impairment showed that exposure to oseltamivir carboxylate is inversely proportional to declining renal function.
Croatian: Primjena oseltamivirfosfata od 100 mg dvaput dnevno tijekom 5 dana u bolesnika s različitim stupnjevima oštećenja bubrežne funkcije pokazala je da je ekspozicija oseltamivir karboksilatu obrnuto proporcionalna oštećenju bubrežne funkcije.
English: On the basis of drug exposure and tolerability, dosage adjustments are not required for older people unless there is evidence of moderate or severe renal impairment (creatinine clearance below 60 ml /min) (see section 4.2).
Croatian: Na temelju ekspozicije i podnošenja lijeka može se zaključiti da u starijih osoba nisu potrebne prilagodbe doze, ako nema dokaza o umjereno ili teško oštećenoj funkciji bubrega (klirens kreatinina manji od 60 ml/min) (vidjeti dio 4.2).
English: Since 2007 naturally occurring resistance associated with the H275Y mutation in seasonal H1N1 strains has been sporadically detected.
Croatian: Od 2007. godine sporadično je primijećena prirodno nastala rezistencija povezana s mutacijom H275Y u sojevima sezonske gripe H1N1.
English: The efficacy of oseltamivir in preventing naturally occurring influenza illness has been demonstrated in a post-exposure prevention study in households that included adults, adolescents, and children aged 1 to 12 years, both as index cases and as family contacts.
Croatian: Djelotvornost oseltamivira u prevenciji gripe pokazana je tijekom ispitivanja prevencije nakon izloženosti virusu u kućanstvima, koje je obuhvaćalo odrasle osobe, adolescente i djecu od 1 do 12 godina, koji su bili indeks slučajevi i obiteljski kontakti.
English: Pharmacokinetic properties of oseltamivir, such as low protein binding and metabolism independent of the CYP450 and glucuronidase systems (see section 5.2), suggest that clinically significant drug interactions via these mechanisms are unlikely.
Croatian: Farmakokinetička svojstva oseltamivira, kao što su slabo vezanje za proteine i metabolizam neovisan o CYP450 i glukuronidazi (vidjeti dio 5.2), upućuju na to da putem tih mehanizama nisu vjerojatne klinički značajne interakcije s drugim lijekovima.
English: The indication in infants below the age of 1 is based upon extrapolation of efficacy data from older children and the recommended posology is based upon pharmacokinetic modelling data (see Section 5.2).
Croatian: Indikacija za primjenu u dojenčadi mlađe od 1 godine temelji se na ekstrapolaciji podataka o djelotvornosti u starije djece, dok se preporuke za doziranje temelje na podacima dobivenima farmakokinetičkim modeliranjem (vidjeti dio 5.2).
English: In exceptional situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older.
Croatian: U iznimnim slučajevima (primjerice, u slučaju nepodudarnosti sojeva virusa koji cirkuliraju i sojeva virusa koji su u cjepivu te u slučaju pandemije) može se razmotriti sezonska prevencija u odraslih i djece s navršenom jednom godinom ili starije.
English: • if you have a severe medical condition, which may require immediate hospitalisation
Croatian: • bolujete li od neke ozbiljne bolesti koju biste morali odmah bolnički liječiti
English: How to take Ebilfumin
Croatian: Kako uzimati Ebilfumin
English: Statistical analyses are therefore presented only for influenza-infected subjects.
Croatian: Stoga se prikazuju samo statistički podaci koji se odnose na osobe zaražene virusom gripe.
English: 90 ml or 100 ml*
Croatian: 90 ml ili 100 ml*
English: Number of capsules and amount of vehicle needed to prepare the total volume of a pharmacy compounded 6 mg/ml suspension Total volume of compounded suspension to be prepared
Croatian: Number of capsules and amount of vehicle needed to prepare the total volume of a pharmacy compounded 6 mg/ml suspension
English: Decisions regarding the use of oseltamivir for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses, available information on influenza drug susceptibility patterns for each season and the impact of the disease in different geographical areas and patient populations (see section 5.1).
Croatian: Prilikom donošenja odluke o upotrebi oseltamivira za liječenje i prevenciju gripe treba uzeti u obzir saznanja o svojstvima cirkulirajućeg virusa gripe, dostupne informacije o obrascima osjetljivosti na lijek protiv gripe za svaku sezonu i utjecaj bolesti u različitim geografskim područjima i populacijama bolesnika (vidjeti dio 5.1).
English: Safety information available on oseltamivir administered for treatment of influenza in infants less than one year of age from prospective and retrospective observational studies (comprising together more than 2,400 infants of that age class), epidemiological databases research and postmarketing reports suggest that the safety profile in infants less than one year of age is similar to the established safety profile of children aged one year and older.
Croatian: Dostupni podaci o sigurnosti oseltamivira primijenjenog za liječenje gripe u dojenčadi mlađe od godinu dana, prikupljeni iz prospektivnih i retrospektivnih opservacijskih ispitivanja (u koja je bilo uključeno više od 2400 dojenčadi te dobne skupine), pretragom epidemioloških baza podataka i postmarketinških izvještaja, ukazuju da je profil sigurnosti u dojenčadi mlađe od godine dana sličan utvrđenom profilu sigurnosti za djecu od godine dana i stariju.
English: Very limited information is available on children breast-fed by mothers taking oseltamivir and on excretion of oseltamivir in breast milk.
Croatian: Dostupni su vrlo ograničeni podaci za dojenčad koja se hranila mlijekom majki koje su uzimale oseltamivir kao i o izlučivanju oseltamivira u majčino mlijeko.
English: Dispense the pharmacy compounded suspension with a graduated oral syringe for measuring small amounts of suspension.
Croatian: Suspenziju pripremljenu u ljekarni izdajte sa štrcaljkom za usta graduiranom za mjerenje malih količina suspenzije.
English: For people who find it hard to take capsules, including very young children, a liquid medicine may be available.
Croatian: Sljedeće informacije namijenjene su korisnicima Za osobe koje ne mogu progutati kapsule, uključujući vrlo malu djecu, može biti dostupan tekući oblik lijeka.
English: Body weight*
Croatian: Tjelesna težina*
English: In vitro studies demonstrated that neither oseltamivir nor the active metabolite is a substrate for, or an inhibitor of, the major cytochrome P450 isoforms.
Croatian: Ispitivanja in vitro pokazala su da ni oseltamivir ni aktivni metabolit nisu supstrati ili inhibitori glavnih izoformi citokroma P450.
English: Caution should be exercised when preparing oseltamivir oral suspension and when administering oseltamivir products to children.
Croatian: Potreban je oprez kod pripreme oralne suspenzije oseltamivira i davanja pripravaka oseltamivira djeci.
English: Children 1 to 12 years Body weight
Croatian: Djeca u dobi od 1 do 12 godina Tjelesna težina
English: Use of oseltamivir must not affect the evaluation of individuals for annual influenza vaccination.
Croatian: Primjena oseltamivira ne smije utjecati na odluku o godišnjem cijepljenju pojedinaca protiv gripe.
English: For measuring 5.0 ml of water, dispensers of 5 ml or 10 ml should be used.
Croatian: Za odmjeravanje 5,0 ml vode treba koristiti štrcaljke od 5 ml ili 10 ml.
English: The primary efficacy parameter for this study was the incidence of laboratory-confirmed clinical influenza in the households.
Croatian: Primarni pokazatelj djelotvornosti u ovom ispitivanju bila je incidencija laboratorijski potvrđene i klinički izražene gripe u kućanstvima.
English: A potential for skin sensitisation to oseltamivir was observed in a "maximisation" test in guinea pigs.
Croatian: Mogućnost senzibilizacije kože na oseltamivir primijećena je u testu "maksimizacije" na zamorcima.
English: The efficacy of oseltamivir in either treatment or prophylaxis of influenza in immunocompromised patients has not been firmly established.
Croatian: Djelotvornost oseltamivira u liječenju ili profilaksi gripe u imunokompromitiranih bolesnika nije sa sigurnošću utvrđena.
English: No dose adjustment is required when co-administering with probenecid in patients with normal renal function.
Croatian: Nije potrebna prilagodba doze kod istodobne primjene s probenecidom u bolesnika s normalnom funkcijom bubrega.
English: In a 12-week prophylaxis study in 475 immunocompromised patients, including 18 children 1 to 12 years of age and older, the safety profile in the 238 patients who received oseltamivir was consistent with that previously observed in oseltamivir prophylaxis clinical studies.
Croatian: U 12-tjednom ispitivanju profilakse provedenom na 475 imunokompromitiranih bolesnika, uključujući 18 djece u dobi od 1 do 12 godina i starije, profil sigurnosti u 238 bolesnika koji su primali oseltamivir bio je u skladu s ranije opaženim profilom u kliničkim ispitivanjima profilaktičke primjene oseltamivira.
English: This is based upon clinical data in infants and children 1 year of age or older and adults showing that a prophylaxis dose equivalent to half the daily treatment dose is clinically efficacious for the prevention of influenza.
Croatian: Preporuka se temelji na kliničkim podacima za dojenčad i djecu u dobi od 1 ili više godina i odrasle, prema kojima je polovica dnevne terapijske doze klinički djelotvorna za prevenciju gripe.
English: In all phase III treatment studies, patients were recruited only during the period in which influenza was circulating in the local community.
Croatian: U svim fazama III kliničkih ispitivanja bolesnici su uključivani u ispitivanje samo u vrijeme kada je gripa kružila lokalnom zajednicom.
English: The active metabolite is eliminated entirely by renal excretion.
Croatian: Aktivni metabolit u potpunosti se eliminira putem bubrega.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), a koji se nalazi u Modulu 1.8.2
English: The safety profile of oseltamivir observed in this study was consistent with that observed in previous clinical trials where oseltamivir was administered for treatment of influenza in nonimmunocompromised patients (otherwise healthy patients or “at risk” patients [i.e., those with respiratory and/or cardiac co-morbidities]).
Croatian: Sigurnosni profil oseltamivira opažen u ovom ispitivanju bio je u skladu s onim opaženim u prethodnim kliničkim ispitivanjima u kojima se oseltamivir primjenjivao za liječenje gripe u bolesnika koji nisu bili imunokompromitirani (bolesnici koji su inače bili zdravi ili „rizični“ bolesnici [tj. oni s bolestima dišnog sustava i/ili srčanim bolestima kao komorbiditetom]).
English: Second, determine the number of capsules and the amount of vehicle (water containing 0.05 % w/v sodium benzoate added as a preservative) that is needed to prepare the total volume (calculated from the table above) of pharmacy compounded 6 mg/ml suspension as shown in the table below:
Croatian: Drugo, potrebno je odrediti broj kapsula i količinu otapala (voda s 0,05 % m/v natrijeva benzoata koji je dodan kao konzervans) koji su potrebni za pripremu ukupnog volumena (izračunatog iz gornje tablice) suspenzije koncentracije 6 mg/ml pripremljene u ljekarni, kao što je prikazano u donjoj tablici:
English: These events were reported primarily among paediatric and adolescent patients and often had an abrupt onset and rapid resolution.
Croatian: Ovi su događaji zabilježeni prvenstveno u pedijatrijskih bolesnika i adolescenata i često su iznenada započinjali i brzo prestajali.
English: To find the correct amount to use, find the patient's weight on the left of the table.
Croatian: Kako biste odredili točnu količinu lijeka koju treba primijeniti, potražite bolesnikovu tjelesnu težinu na lijevoj strani tablice.
English: The signs of flu often include a sudden fever (more than 37.8 °C), cough, runny or stuffy nose, headaches, muscle aches and extreme tiredness.
Croatian: Simptomi gripe često uključuju nagli porast temperature (više od 37,8 °C), kašalj, curenje ili začepljenje nosa, glavobolju, bolove u mišićima i izrazit umor.
English: Prevention during an influenza epidemic in the community: The recommended dose for prevention of influenza during a community outbreak is 75 mg oseltamivir once daily for up to 6 weeks.
Croatian: Prevencija tijekom epidemije gripe u zajednici: Preporučena doza za prevenciju gripe tijekom izbijanja epidemije u zajednici iznosi 75 mg oseltamivira jednom dnevno tijekom najviše 6 tjedana.
English: There is insufficient clinical data available in infants and children (12 years of age and younger) with renal impairment to be able to make any dosing recommendation.
Croatian: Nema dovoljno kliničkih podataka u dojenčadi i djece (u dobi od 12 godina i mlađe) s oštećenjem funkcije bubrega da bi se mogle dati preporuke za doziranje.
English: Bronchitis, Herpes simplex, Nasopharyngitis, Upper respiratory tract infections, Sinusitis
Croatian: Infekcije i infestacije bronhitis, herpes simplex, nazofaringitis, infekcije gornjih dišnih putova, sinusitis
English: These patients were randomized to be treated, within 96 hours of symptoms onset, with standard dose (73 patients) or double dose (78 patients) of oseltamivir, for a duration of 10 days.
Croatian: Ti su bolesnici bili randomizirani za liječenje, unutar 96 sati od nastupa simptoma, standardnom dozom (73 bolesnika) ili dvostrukom dozom (78 bolesnika) oseltamivira tijekom 10 dana.
English: Oseltamivir has no influence on the ability to drive and use machines.
Croatian: Oseltamivir ne utječe na sposobnost upravljanja vozilima i rada na strojevima.
English: You should use only 30 mg capsules for 30 mg and 60 mg doses.
Croatian: Kapsule od 30 mg smijete koristiti samo za doze od 30 mg i 60 mg.
English: Peak plasma concentrations of oseltamivir carboxylate decline with a half-life of 6 to 10 hours in most subjects.
Croatian: Vršne koncentracije oseltamivir karboksilata u plazmi u većine ispitanika smanjuju se s poluvremenom od 6 do 10 sati.
English: • Stevens-Johnson syndrome and toxic epidermal necrolysis: complicated, possibly lifethreatening allergic reaction, severe inflammation of the outer and possibly inner skin, initially with fever, sore throat, and fatigue, skin rashes, leading to blisters, peeling, shedding of larger areas of skin, possible breathing difficulties and low blood pressure
Croatian: • Stevens-Johnsonov sindrom i toksična epidermalna nekroliza: komplicirana alergijska reakcija koja može biti opasna po život, teška upala vanjskog, a možda i unutarnjeg sloja kože, koja počinje s vrućicom, grloboljom i umorom, osip kože koji se razvija u mjehuriće, ljuštenje većih područja kože, moguće otežano disanje i nizak krvni tlak
English: However, for adult immunocompromised patients with renal impairment, doses should be adjusted as outlined in section 4.2.
Croatian: Međutim, u odraslih imunokompromitiranih bolesnika s oštećenjem bubrežne funkcije doze treba prilagoditi kako je navedeno u dijelu 4.2 'Doziranje i način primjene'.
English: Place a pharmacy label on the bottle that includes the patient's name, dosing instructions, use by date, name of medicinal product and any other required information to be in compliance with local pharmacy regulations.
Croatian: Na bočicu nalijepite naljepnicu s imenom bolesnika, uputama za doziranje, rokom valjanosti, nazivom lijeka i drugim potrebnim informacijama u skladu s lokalnim ljekarničkim propisima.
English: Hepato-biliary system disorders, including hepatitis and elevated liver enzymes in patients with influenza-like illness.
Croatian: Bolesti jetre i žuči, uključujući hepatitis i povišenu razinu jetrenih enzima u bolesnika sa bolešću sličnom gripi.
English: A rat fertility study up to a dose of 1,500 mg/kg/day demonstrated no adverse reactions on either sex.
Croatian: Ispitivanje fertiliteta uz doze do 1500 mg/kg/dan na štakorima pokazalo je da nema neželjenih učinaka ni za jedan spol.
English: The use of Ebilfumin may be considered during pregnancy if necessary and after considering the available safety and benefit information (for data on benefit in pregnant women please refer to section 5.1 “treatment of influenza in pregnant women”), and the pathogenicity of the circulating influenza virus strain.
Croatian: Primjena lijeka Ebilfumin u trudnoći može se razmotriti ako je to potrebno i nakon razmatranja dostupnih informacija o sigurnosti i koristi (za podatke o koristi u trudnica vidjeti 'Liječenje gripe u treudnica u dijelu 5.1) i podataka o patogenosti cirkulirajućeg soja virusa gripe.
English: In addition, 199 immunocompromised adult patients received oseltamivir for the treatment of influenza and 475 immunocompromised patients (including 18 children, of these 10 oseltamivir and 8 placebo) received oseltamivir or placebo for the prophylaxis of influenza.
Croatian: Uz to je 199 imunokompromitiranih odraslih bolesnika primilo oseltamivir za liječenje gripe, dok je 475 imunokompromitiranih bolesnika (uključujući 18 djece, od kojih je 10 primalo oseltamivir, a 8 placebo) primilo oseltamivir ili placebo radi profilakse gripe.
English: These symptoms can also be caused by other infections.
Croatian: Osim gripe iste simptome mogu izazvati i druge infekcije.
English: In patients with influenza who were receiving oseltamivir, there have been postmarketing reports of convulsions and delirium (including symptoms such as altered level of consciousness, confusion, abnormal behaviour, delusions, hallucinations, agitation, anxiety, nightmares), in a very few cases resulting in self-injury or fatal outcomes.
Croatian: Kod oboljelih od gripe koji su primali oseltamivir, u razdoblju nakon stavljanja lijeka u promet prijavljene su konvulzije i delirij (uključujući simptome kao što su promijenjena razina svijesti, konfuzija, abnormalno ponašanje, deluzije, halucinacije, agitacija, anksioznost i noćne more), koji su u vrlo malom broju slučajeva doveli do samoozljeđivanja ili smrti.
English: In the majority of cases reporting overdose, no adverse events were reported.
Croatian: U većini prijavljenih slučajeva predoziranja nisu prijavljene nuspojave.
English: [Only applicable for outer packaging:] PC: {number}
Croatian: [Primjenjivo samo za vanjsko pakiranje:] PC:
English: Ebilfumin has no effect on your ability to drive or use machines.
Croatian: Ebilfumin ne utječe na sposobnost upravljanja vozilima i strojevima.
English: Psychiatric disorders and nervous system disorders Influenza can be associated with a variety of neurologic and behavioural symptoms which can include events such as hallucinations, delirium, and abnormal behaviour, in some cases resulting in fatal outcomes.
Croatian: Gripu se može povezati s brojnim neurološkim simptomima i promjenama ponašanja koje mogu obuhvaćati događaje poput halucinacija, delirija i abnormalnog ponašanja, koji u nekim slučajevima mogu imati smrtni ishod.
English: A total of 158 children received the recommended dose of oseltamivir once daily in a post-exposure prophylaxis study in households (n = 99), a 6-week paediatric seasonal prophylaxis study (n = 49) and a 12week paediatric seasonal prophylaxis study in immunocompromised subjects (n = 10).
Croatian: Ukupno je 158 djece primalo preporučenu dozu oseltamivira jednom dnevno i to u ispitivanju profilakse nakon izlaganja virusu u kućanstvima (n = 99), u 6-tjednoj pedijatrijskoj studiji sezonske profilakse (n = 49) te u 12tjednoj pedijatrijskoj studiji sezonske profilakse u imunokompromitiranih bolesnika (n = 10) .
English: • Two small bowls
Croatian: • dvije zdjelice
English: Treatment: The recommended oral dose is 75 mg oseltamivir twice daily for 10 days for adults (see sections 4.4, 4.8 and 5.1).
Croatian: Liječenje: Preporučena peroralna doza za odrasle je 75 mg oseltamivira dvaput na dan tijekom 10 dana (vidjeti dijelove 4.4, 4.8 i 5.1).
English: Incidence of Oseltamivir Resistance in Clinical Studies Patient Population
Croatian: Incidencija rezistencije na oseltamivir u kliničkim ispitivanjima
English: 3 mg per kg body weight, twice daily
Croatian: 3 mg po kg tjelesne težine, dvaput dnevno
English: The safety profile reported in subjects who received the recommended dose of oseltamivir for prophylaxis (75 mg once daily for up to 6 weeks) was qualitatively similar to that seen in the treatment studies, despite a longer duration of dosing in the prophylaxis studies.
Croatian: Sigurnosni profil zabilježen u osoba koje su primale preporučenu dozu oseltamivira za profilaksu (75 mg jednom dnevno tijekom najdulje 6 tjedana) bio je kvalitativno sličan onomu zabilježenom u studijama liječenja usprkos duljem uzimanju lijeka u studijama profilakse.
English: How much mixture to draw up
Croatian: Koliko mješavine treba uvući u štrcaljku