natgillin/translations-raw huggingface dataset:
Ebilfumin contains oseltamivir, which belongs to a group of medicines named neuraminidase inhibitors.
Ebilfumin sadrži oseltamivir, koji pripada skupini lijekova pod nazivom inhibitori neuraminidaze.
Add the water to the powder in the bowl.
Dodajte vodu u zdjelicu s prahom.
Developing oseltamivir-resistant virus during treatment was more frequent in children than adults, ranging from less than 1% in adults to 18% in infants aged below 1 year.
Razvoj virusa rezistentnih na oseltamivir tijekom liječenja zabilježen je češće u djece nego u odraslih, a kretao se u rasponu od manje od 1% u odraslih do 18% u dojenčadi mlađe od 1 godine.
It can be used when you have flu symptoms, and the flu virus is known to be going round in your community.
Može se koristiti kada imate simptome gripe, a poznato je da virus gripe kruži u zajednici.
The column on the right of the table shows how much of the liquid mixture you will need to draw up.
U stupcu na desnoj strani tablice navodi se koliko tekuće mješavine trebate navući.
Due to the wide safety margin of the active metabolite, no dose adjustments are required in adults due to their immunocompromised status.
S obzirom na široku sigurnosnu marginu aktivnog metabolita, nije potrebno prilagođavati dozu u odraslih bolesnika prema statusu imunokompromitiranosti.
The virulence of influenza epidemics is not predictable and varies within a region and from season to season, therefore the number needed to treat (NNT) in order to prevent one case of influenza illness varies.
Virulentnost gripe nije predvidiva i razlikuje se od područja do područja te od sezone do sezone, zbog čega varira i broj osoba koje treba liječiti (NNT = number needed to treat) da bi se spriječio jedan slučaj gripe.
Of the older subjects, 64 % were influenza-positive and of those with chronic cardiac and/or respiratory disease 62 % were influenza-positive.
Među starijim ispitanicima bilo je 64 % influencapozitivnih, a među onima s kroničnim srčanim ili respiratornim oboljenjima bilo je 62 % influencapozitivnih.
The majority of these ARs were reported on a single occasion on either the first or second treatment day and resolved spontaneously within 1-2 days.
U većini slučajeva, navedene nuspojave su se pojavile jednokratno, prvi ili drugi dan uzimanja lijeka i spontano su nestajale unutar 1-2 dana.
The lower predicted exposure however, remains above inhibitory concentrations (IC95 values) and at a therapeutic level for a range of influenza virus strains.
Međutim, ta niža predviđena razina izloženosti i dalje se nalazi iznad inhibicijskih koncentracija (vrijednosti IC95) i na razini kojom se ostvaruje terapijski učinak na čitav niz sojeva virusa gripe.
See Section 5.2 for exposure simulation details.
Vidjeti dio 5.2 za detalje vezane za simulaciju izloženosti virusu.
Oseltamivir prophylaxis lasted for 10 days.
Profilaksa oseltamivirom trajala je 10 dana.
In the oseltamivir treated group, the median duration of illness was not reduced significantly.
U skupini koja je primala oseltamivir, medijan trajanja bolesti se nije značajno smanjio.
Additional information
Dodatni podaci
This pharmacy preparation is the preferred option.
Taj ljekarnički pripravak je opcija kojoj se daje prednost.
The rate of clearance of the active metabolite, corrected for bodyweight, decreases with ages below one year.
Brzina klirensa aktivnog metabolita, korigirana za tjelesnu težinu, smanjuje se s dobi manjom od jedne godine.
Children with pre-existing bronchial asthma
Djeca koja boluju od bronhalne astme
For home preparation, separate dispensers should be provided for taking the correct volume of water and for measuring the Ebilfumin-water mixture.
Za pripremu kod kuće treba osigurati odvojene štrcaljke za uzimanje točnog volumena vode i za odmjeravanje potrebne količine mješavine Ebilfumin-voda.
Therefore, dose adjustments are not recommended for pregnant women in the treatment or prophylaxis of influenza (see section 4.6 Fertility, pregnancy and lactation).
Stoga se ne preporučuje prilagođavati dozu za liječenje ili profilaksu gripe u trudnica (vidjeti dio 4.6 Plodnost, trudnoća i dojenje).
When only 75 mg capsules are available, and doses of 30 mg or 45 mg are needed, the preparation of Ebilfumin suspension involves additional steps.
Kada su dostupne samo kapsule od 75 mg, a potrebne su doze od 30 mg ili 45 mg, priprema Ebilfumin suspenzije uključuje dodatne korake.
Considering the margins of exposure in relation to the expected exposure in the human use, these findings do not change the benefit-risk of oseltamivir in its adopted therapeutic indications.
Uzimajući u obzir granice ekspozicije u odnosu na očekivanu ekspoziciju u ljudi, ta otkrića ne mijenjaju odnos koristi i rizika pri primjeni oseltamivira u prihvaćenim terapijskim indikacijama.
Table 2 shows the most frequently reported ARs from paediatric clinical trials.
U Tablici 2 prikazane su najčešće prijavljivane nuspojave u pedijatrijskim kliničkim ispitivanjima.
Dermatitis (including allergic and atopic dermatitis)
(uključujući alergijski i atopijski dermatitis)
• Neuropsychiatric disorders, as described below.
• neuropsihijatrijski poremećaji opisani u nastavku
Draw up the correct amount of liquid mixture from the first bowl.
Navucite točnu količinu tekuće mješavine iz prve zdjelice.
In both cases, the correct volumes should preferably be marked on the syringes.
U oba slučaja, bilo bi poželjno potrebne volumene naznačiti na štrcaljkama.
If so, your dose may need adjustment
U tom će slučaju možda trebati prilagoditi dozu.
Shelf life of 6 weeks at 2°C - 8°C.
Rok valjanosti je 6 tjedana ako se čuva na temperaturi 2°C - 8°C.
Stir the mixture with the teaspoon for about 2 minutes.
Miješajte sadržaj čajnom žličicom oko 2 minute.
For all patients under the age of 1 year, 3 mg/kg should be used to determine dose regardless of the weight of the patient.
Za sve bolesnike mlađe od 1 godine dozu treba određivati na bazi 3 mg/kg, bez obzira na težinu bolesnika.
However, the duration of treatment of influenza in immunocompromised adult patients should be 10 days, as there are no studies of a shorter course of oseltamivir in this patient group (see section 5.1).
Međutim, liječenje gripe u imunokompromitiranih odraslih bolesnika trebalo bi trajati 10 dana jer nisu provedena ispitivanja kraćeg liječenja oseltamivirom u toj skupini bolesnika (vidjeti dio 5.1).
The total volume required is determined by the weight of the patient according to the recommendation in the table below.
Potreban ukupni volumen određuje se na temelju tjelesne težine bolesnika prema preporukama u donjoj tablici.
Absorbed oseltamivir is primarily (> 90 %) eliminated by conversion to oseltamivir carboxylate.
Apsorbirani oseltamivir uglavnom se (> 90 %) eliminira pretvorbom u oseltamivir karboksilat.
The active metabolite is a selective inhibitor of influenza virus neuraminidase enzymes, which are glycoproteins found on the virion surface.
Aktivni metabolit selektivni je inhibitor enzima neuraminidaze virusa gripe, glikoproteina koji se nalaze na površini viriona.
Open the stated amount of Ebilfumin capsules and transfer the content of each capsule directly to the preserved water in the glass beaker.
Otvorite navedeni broj Ebilfumin kapsula te prebacite sadržaj svake kapsule izravno u vodu s konzervansom u staklenoj graduiranoj čaši.
• if you have problems with your kidneys.
• imate li problema s bubrezima.
Oseltamivir should be used for the treatment and prevention of influenza only when reliable epidemiological data indicate that influenza virus is circulating in the community.
Oseltamivir treba koristiti za liječenje i prevenciju gripe samo ako se na temelju pouzdanih epidemioloških podataka može zaključiti da virus gripe kruži zajednicom.
Many of the side effects listed below may also be caused by influenza.
Mnoge od sljedećih nuspojava mogu biti i posljedica gripe.
To allow for accurate volume withdrawal of up to 10 doses (2 withdrawals per daily treatment dose for 5 days), the column indicating measurement loss is to be considered for compounding.
Kako bi se omogućilo precizno izvlačenje najviše 10 doza (2 izvlačenja terapijske doze dnevno tijekom 5 dana), kod pripreme se mora uzeti u obzir stupac u kojemu se navodi gubitak pri odmjeravanju.
Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms.
Dokazana je djelotvornost ako se liječenje započne unutar dva dana od pojave prvih simptoma.
If you stop taking Ebilfumin
Ako prestanete uzimati Ebilfumin
• If you need smaller doses, making Ebilfumin suspension from capsules involves extra steps.
• Ako su Vam potrebne manje doze lijeka, priprema Ebilfumin suspenzije iz kapsula uključuje dodatne korake.
For preventing flu or after being exposed to an infected person, take one dose daily for 10 days.
Za prevenciju gripe ili nakon kontakta sa zaraženom osobom uzimajte jednu dozu dnevno tijekom
Stop taking Ebilfumin and contact a doctor or pharmacist immediately.
Prestanite uzimati Ebilfumin i odmah se obratite liječniku ili ljekarniku.
Oseltamivir has no kinetic interaction with amoxicillin, which is eliminated via the same pathway, suggesting that oseltamivir interaction with this pathway is weak.
Oseltamivir nema kinetičke interakcije s amoksicilinom, koji se izlučuje istim putem, što upućuje na to da je interakcija oseltamivira tim putem slaba.
Step 3: Sweeten the powder and give the dose
3. korak: Zasladite prah i dajte dozu
Post-exposure prevention: The recommended post-exposure prevention dose of Ebilfumin is:
Prevencija nakon izloženosti virusu: Preporučena preventivna doza lijeka Ebilfumin nakon izloženosti virusu iznosi:
Viral neuraminidase enzyme activity is important both for viral entry into uninfected cells and for the release of recently formed virus particles from infected cells, and for the further spread of infectious virus in the body.
Aktivnost enzima virusne neuraminidaze važna je i za ulazak virusa u nezaražene stanice i za oslobađanje tek formiranih virusnih čestica iz zaraženih stanica te za daljnje širenje virusa u tijelu.
No phase 2 conjugates of either compound have been identified in vivo.
Ni za jedan od tih spojeva nisu in vivo identificirani konjugati faze 2.
If there is anything left in the second bowl, rinse the bowl with a small amount of water and get the child to drink it all.
Ako je u drugoj zdjelici nešto preostalo, isperite zdjelicu malom količinom vode i neka dijete sve to popije.
Results of the conventional rodent carcinogenicity studies showed a trend towards a dose-dependent increase in the incidence of some tumours that are typical for the rodent strains used.
Rezultati konvencionalnih ispitivanja karcinogenosti na glodavcima pokazali su trend o dozi ovisnog povećanja incidencije nekih tumora tipičnih za korištene sojeve glodavaca.
The pharmacy preparation should be preferred to home preparation.
Prednost treba dati ljekarničkom pripravku u odnosu na pripravak izrađen kod kuće.
You must use the amount of oral capsules or suspension prescribed by the doctor.
Morate koristiti količinu oralnih kapsula ili suspenziju propisane od strane liječnika.
once daily mg per kg = mg for each kilogram of the infant's body weight.
3 mg/kg jednom dnevno mg/kg = mg po svakom kilogramu tjelesne težine djeteta.
In special situations, such as widespread flu or for patients with a weak immune system, treatment will continue for up to 6 or 12 weeks.
U posebnim okolnostima kao što je rasprostranjena gripa te u bolesnika s oslabljenim imunološkim sustavom liječenje će trajati najdulje 6 ili 12 tjedana.
A vaccine gives you antibodies against the virus.
Cjepivo stvara protutijela protiv virusa.
Always complete the course that your doctor prescribed.
Uvijek dovršite cijelu terapiju koju Vam je propisao liječnik.
[Only applicable for outer packaging:] 2D barcode carrying the unique identifier included.
[Primjenjivo samo za vanjsko pakiranje:] Sadrži 2D barkod s jedinstvenim identifikatorom.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister
Renal clearance (18.8 l/h) exceeds glomerular filtration rate (7.5 l/h) indicating that tubular secretion occurs in addition to glomerular filtration.
Bubrežni klirens (18,8 l/h) premašuje brzinu glomerularne filtracije (7,5 l/h), što upućuje da se uz glomerularnu filtraciju odvija i tubularna sekrecija.
Whereas very high oral single doses of oseltamivir phosphate salt, up to the highest dose tested (1,310 mg/kg), had no adverse reactions in adult rats, such doses resulted in toxicity in juvenile 7-day- old rat pups, including death.
Dok vrlo visoke jednokratne peroralne doze soli oseltamivirfosfata, do najveće testirane doze (1310 mg/kg) nisu imale štetan utjecaj na odrasle štakore, takve doze su kod mladih, 7 dana starih štakora izazivale toksičnost, uključujući i smrt.
In general, the adverse reaction profile in children with pre-existing bronchial asthma was qualitatively similar to that of otherwise healthy children.
Profil nuspojava u djece koja boluju od bronhalne astme bio je kvalitativno sličan onomu u inače zdrave djece.
Step 2: Add water to dilute the medicine
2. korak: Dodajte vodu da razrijedite lijek
Approximately 50 % of the animals treated with the unformulated active substance showed erythema after challenging the induced animals.
Približno 50 % životinja koje su primale neformuliranu djelatnu tvar imalo je eritem.
Susceptibility of circulating influenza virus strains to oseltamivir has been shown to be highly variable (see section 5.1).
Pokazalo se da je osjetljivost cirkulirajućih sojeva virusa gripe na oseltamivir vrlo promjenjiva (vidjeti dio 5.1).
Exposure to the active metabolite at steady state was 25 to 35 % higher in older people (age 65 to 78 years) compared to adults less than 65 years of age given comparable doses of oseltamivir.
Ekspozicija aktivnom metabolitu u stanju dinamičke ravnoteže bila je 25 % do 35 % veća u starijih osoba (od 65 do 78 godina) u usporedbi s odraslim bolesnicima mlađima od 65 godina koji su primali usporedive doze oseltamivira.
It is not further metabolised and is eliminated in the urine.
Aktivni metabolit dalje se ne metabolizira i eliminira se urinom.
- Ebilfumin is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2).
- Ebilfumin je indiciran za prevenciju gripe u dojenčadi mlađe od 1 godine nakon njihove izloženosti virusu gripe tijekom pandemije (vidjeti dio 5.2).
True influenza infection only occurs during annual outbreaks (epidemics) when flu viruses are spreading in the local community.
Prava infekcija gripom događa se samo tijekom godišnjih epidemija u vrijeme kada se virus gripe širi zajednicom.
Paediatric population (infants less than one year of age)
Pedijatrijska populacija (dojenčad mlađa od godine dana)
Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar.
Možete pripremiti i šećernu vodu: pomiješajte žličicu vode s tri četvrtine (3/4) žličice šećera.
137.5 ml (or 150 ml)*
137,5 ml (ili 150 ml)*
* There is no combination of this capsule strength that can be used to achieve the target concentration; therefore, please use an alternative capsule strength.
* Nije moguće postići ciljnu koncentraciju lijeka kombinacijom ove jačine kapsula; stoga treba upotrijebiti drugu jačinu kapsula.
Pharmacotherapeutic group: Antivirals for systemic use, neuraminidase inhibitors, ATC code: J05AH02
5.1 Farmakodinamička svojstva Farmakoterapijska skupina: Lijekovi za liječenje sustavnih virusnih infekcija, inhibitori neuraminidaze; ATK oznaka: J05AH02
Put an ancillary label on the bottle indicating “Shake Gently Before Use”.
Na bočicu nalijepite dodatnu naljepnicu s uputom “Nježno protresti prije upotrebe”.
Total volume of compounded suspension to be prepared
Ukupan volumen suspenzije koji treba pripremiti
Since neuraminidase activity is extracellular, oseltamivir carboxylate distributes to all sites of influenza virus spread.
Budući da je aktivnost neuraminidaze izvanstanična, oseltamivir karboksilat distribuira se na sva mjesta na koja se širi virus gripe.
Oseltamivir is effective only against illness caused by influenza viruses.
Oseltamivir je učinkovit samo protiv bolesti uzrokovane virusima gripe.
Treatment of influenza in pregnant women: No controlled clinical studies have been conducted on the use of oseltamivir in pregnant women, however, there is evidence from post-marketing and retrospective observational studies showing benefit of the current dosing regimen in this patient population in terms of lower morbidity/mortality.
Liječenje gripe u trudnica: Nisu provedena kontrolirana klinička ispitivanja primjene oseltamivira u trudnica, međutim, postoje dokazi prikupljeni tijekom praćenja lijeka nakon stavljanja u promet i retrospektivnih opservacijskih ispitivanja koji pokazuju korisne učinke sadašnjeg režima doziranja u ovoj populaciji bolesnica u smislu manjeg pobola/smrtnosti.
In the majority of patients, these ARs did not lead to discontinuation of oseltamivir.
U većine bolesnika te nuspojave nisu uzrokovale prekid primjene oseltamivira.
Immunocompromised patients and young children are at a higher risk of developing oseltamivir-resistant virus during treatment.
Imunokompromitirani bolesnici i mlađa djeca imaju, tijekom liječenja, veći rizik za razvoj virusa rezistentnih na oseltamivir.
Treatment of influenza B infection: Overall, 15 % of the influenza-positive population were infected by influenza B, proportions ranging from 1 to 33 % in individual studies.
B: Ukupno je 15 % influenca-pozitivne populacije bilo zaraženo gripom B, a odnosi su u pojedinačnim ispitivanjima varirali od 1 % do 33 %.
Clinically important drug interactions involving competition for renal tubular secretion are unlikely, due to the known safety margin for most of these substances, the elimination characteristics of the active metabolite (glomerular filtration and anionic tubular secretion) and the excretion capacity of these pathways.
Klinički značajne interakcije s drugim lijekovima koje bi uključivale kompeticiju za renalnu tubularnu sekreciju nisu vjerojatne zbog poznate sigurnosne širine većine tih lijekova, eliminacijskih karakteristika aktivnog metabolita (glomerularna filtracija i anionska tubularna sekrecija) te kapaciteta izlučivanja tih puteva.
In children, the most commonly reported adverse reaction was vomiting.
Najčešće prijavljena nuspojava u djece bilo je povraćanje.
If there is some mixture left in the bowl, rinse the bowl with a small amount of water and get the patient to drink it all.
Ako je u zdjelici ostalo nešto mješavine, isperite zdjelicu malom količinom vode i dajte bolesniku da sve to popije.
Exposure to the pro-drug is less than 5 % relative to the active metabolite.
Ekspozicija predlijeku u usporedbi s aktivnim metabolitom iznosi manje od 5 %.
Recommended doses are detailed in the table below.
Preporučene doze navedene su u sljedećoj tablici.
Transfer the suspension to an amber glass or amber polyethyleneterephthalate (PET) bottle.
Premjestite suspenziju u smeđu staklenu bočicu ili smeđu bočicu od polietilentereftalata (PET).
Younger children cleared both the pro-drug and its active metabolite faster than adults, resulting in a lower exposure for a given mg/kg dose.
U mlađe djece se predlijek i aktivni metabolit uklanja brže nego u odraslih, što rezultira manjom ekspozicijom dozi danoj u mg/kg.
• Upper respiratory tract infections (inflammation of the nose, throat and sinuses)
• infekcije gornjih dišnih putova (upala nosa, grla i sinusa)
Patients with Resistance Mutations (%) Phenotyping* Geno- and Phenotyping*
Bolesnici s otpornim sojevima (%) Fenotipizacija*
Gently squirt the correct dose into the second bowl.
Nježno izlijte točnu dozu u drugu zdjelicu.
When side effects were reported, they were similar to those from normal doses, as listed in section 4.
Kada su prijavljene nuspojave, one su bile slične onima kod uzimanja normalnih doza, koje su popisane u dijelu
The ARs listed in the tables below fall into the following categories: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), and very rare (< 1/10,000).
Tablični prikaz nuspojava Nuspojave navedene u sljedećim tablicama razvrstane su prema učestalosti u sljedeće kategorije: vrlo česte (≥ 1/10), česte (≥ 1/100 i < 1/10), manje česte (≥ 1/1000 i < 1/100), rijetke (≥ 1/10 000 i
The primary endpoint in this study was the incidence of laboratory-confirmed clinical influenza as determined by viral culture and/or a four-fold rise in HAI antibodies.
Primarna mjera ishoda ispitivanja bila je odrediti incidenciju kliničke, laboratorijski potvrđene gripe, određene na temelju virusne kulture i/ili četverostrukog povećanja HAI antitijela.
Neuropsychiatric events have been reported during administration of oseltamivir in patients with influenza, especially in children and adolescents.
Neuropsihijatrijski događaji su prijavljivani tijekom primjene oseltamivira kod oboljelih od gripe, posebno kod djece i adolescenata.
No information is available regarding the safety and efficacy of oseltamivir in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalisation.
Nisu dostupne informacije o sigurnosti i djelotvornosti oseltamivira u bolesnika u bilo kojem medicinski ozbiljnom ili nestabilnom stanju za koje može biti potrebna hospitalizacija.
Infants and children 1 year of age or older: The pharmacokinetics of oseltamivir have been evaluated in single-dose pharmacokinetic studies in infants, children and adolescents 1 to 16 years of age.
Dojenčad i djeca u dobi od 1 godine i starija: Farmakokinetika oseltamivira ocjenjivana je tijekom farmakokinetičkog ispitivanja primjene jednokratne doze u dojenčadi, djece i adolescenata u dobi od 1 do 16 godina.
Make sure you have the right size dispenser.
Provjerite imate li pravilnu veličinu štrcaljke.
Teratology studies have been conducted in rats and rabbits at doses of up to 1,500 mg/kg/day and 500 mg/kg/day, respectively.
Ispitivanje teratogenosti provedeno je na štakorima i kunićima u dozama do 1500 mg/kg/dan, odnosno 500 mg/kg/dan.
Plasma concentrations of both pro-drug and active metabolite are proportional to dose and are unaffected by co-administration with food.
Koncentracije predlijeka i aktivnog metabolita u plazmi proporcionalne su dozi i na njih ne utječe istodobno uzimanje hrane.
The pharmacokinetics of oseltamivir in children and adolescents 12 years of age or older are similar to those in adults.
Farmakokinetika oseltamivira u djece i adolescenata u dobi od 12 godina i starijih jednaka je onoj u odraslih osoba.
Label for HDPE tablet container and outer carton for tablet container and blister
Naljepnica na HDPE spremniku s tabletama i kutija za spremnik s tabletama i blisterom
Older people and patients with chronic cardiac and/or respiratory disease The population included in the influenza treatment studies is comprised of otherwise healthy adults/adolescents and patients “at risk” (patients at higher risk of developing complications associated with influenza, e.g. older people and patients with chronic cardiac or respiratory disease).
Stariji osobe i bolesnici s kroničnim srčanim bolestima i/ili bolestima dišnog sustava Populacija uključena u ispitivanja liječenja gripe sastojala se od inače zdravih odraslih osoba/ adolescenata i „rizičnih“ bolesnika (bolesnika s povećanim rizikom za razvoj komplikacija povezanih s gripom kao što su starije osobe i bolesnici s kroničnim bolestima srca ili dišnog sustava).
Overdose has been reported more frequently for children than adults and adolescents.
Predoziranje je češće zabilježeno u djece nego u odraslih i adolescenata.
Recommended dose for prevention
Preporučena doza za prevenciju
Ebilfumin is indicated in adults and children including full-term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community.
Ebilfumin je indiciran u odraslih i djece, uključujući terminsku novorođenčad , koji imaju simptome tipične za gripu kada je virus gripe raširen u zajednici.