FrancophonIA/ELRC3.0 huggingface dataset:
English: How to prepare the infusion for intravenous administration:
Croatian: Kako pripremiti infuziju za intravensku primjenu:
English: Some people may also have hallucinations (seeing, hearing, or feeling things that are not there) or fits (seizures) which can lead to loss of consciousness.
Croatian: Neke osobe mogu imati i halucinacije (kod kojih vide, čuju ili osjećaju stvari koje nisu prisutne) ili napadaje koji mogu dovesti do gubitka svijesti.
English: Neuropsychiatric events
Croatian: Neuropsihijatrijski događaji
English: The initial 5 day treatment course could be extended for up to 5 additional days if clinical symptoms or patient characteristics warranted further treatment.
Croatian: Početni 5-dnevni ciklus liječenja mogao se produljiti za do 5 dodatnih dana ako su klinički simptomi ili bolesnikove značajke zahtijevali daljnje liječenje.
English: It is used when other flu treatments are not suitable.
Croatian: Koristi se kada druge terapije za gripu nisu prikladne.
English: There is no specific antidote to treat an overdose of this medicine.
Croatian: Nema specifičnog antidota za liječenje predoziranja ovim lijekom.
English: Belgique/Belgien
Croatian: België/Belgique/Belgien
English: Sudden changes in behaviour, hallucinations and fits
Croatian: Iznenadne promjene u ponašanju, halucinacije i napadaji
English: • if you are allergic to zanamivir or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na zanamivir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Dectova must not be mixed with other medicinal products except those mentioned in section 6.6.
Croatian: Dectova se ne smije miješati s drugim lijekovima osim onih navedenih u dijelu 6.6.
English: The safety and efficacy of Dectova in children aged under 6 months have not been established.
Croatian: Sigurnost i djelotvornost lijeka Dectova u djece mlađe od 6 mjeseci nisu ustanovljene.
English: • liver damage (hepatocellular injury)
Croatian: • oštećenje jetre (hepatocelularno oštećenje)
English: Contact your doctor or nurse straight away if you notice any of the following serious side effects:
Croatian: Odmah se obratite liječniku ili medicinskoj sestri ako primijetite bilo koju od sljedećih ozbiljnih nuspojava:
English: Dectova is administered by intravenous infusion over 30 minutes.
Croatian: Intravenski Dectova se primjenjuje intravenskom infuzijom tijekom 30 minuta.
English: • Calculate the required dose and volume of Dectova.
Croatian: • Izračunajte potrebnu dozu i volumen lijeka Dectova.
English: • seeing, hearing or feeling things which are not there
Croatian: • stanje kod kojega osoba vidi, čuje ili osjeća stvari koje nisu prisutne
English: All patients must have their renal function assessed before and regularly during treatment.
Croatian: Svim se bolesnicima bubrežna funkcija mora ocijeniti prije i redovito tijekom liječenja.
English: • Each vial is for single use only; once the seal has been broken, the remaining volume must be discarded.
Croatian: • Svaka je bočica namijenjena samo za jednokratnu uporabu; nakon skidanja zaštitnog zatvarača sav preostali volumen mora se baciti.
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stanovišta lijek se mora odmah primijeniti.
English: The volume of distribution of zanamivir in adults is approximately 16 litres, which approximates the volume of extracellular water.
Croatian: Volumen distribucije zanamivira u odraslih iznosi približno 16 litara, što približno odgovara volumenu izvanstanične vode.
English: Overall, the safety profile in paediatric patients was similar to that observed in adults in the clinical studies.
Croatian: Sveukupno je sigurnosni profil u pedijatrijskih bolesnika bio sličan onom opaženom u odraslih bolesnika u kliničkim ispitivanjima.
English: Table 7: Pharmacokinetic parameters in paediatric and adult subjects
Croatian: Tablica 7: Farmakokinetički parametri u pedijatrijskih i odraslih ispitanika
English: Serious hypersensitivity reactions
Croatian: Ozbiljne reakcije preosjetljivosti
English: Treatment of an overdose should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Croatian: Liječenje predoziranja treba se sastojati od općih potpornih mjera, koje uključuju praćenje vitalnih znakova i kliničkog statusa bolesnika.
English: The most important serious adverse reaction was hepatocellular injury, observed in two patients (<1%).
Croatian: Najvažnija ozbiljna nuspojava bilo je hepatocelularno oštećenje, koje je zabilježeno u dva bolesnika (< 1%).
English: Patients were stratified at randomisation based on time from onset of symptoms to initiation of treatment (≤4 days and 5 to 6 days).
Croatian: Bolesnici su pri randomizaciji stratificirani prema vremenu od nastupa simptoma do uvođenja liječenja (≤ 4 dana i 5 - 6 dana).
English: It is unlikely that you will be given too much, but if you think you have been given too much Dectova, tell your doctor or nurse immediately.
Croatian: Nije vjerojatno da ćete primiti previše lijeka Dectova, ali ako mislite da se to dogodilo, odmah to recite svom liječniku ili medicinskoj sestri.
English: Like all medicines, Dectova can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Dectova može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Therefore, patients should be closely monitored for behavioural changes and the benefits and risks of continuing treatment should be carefully evaluated for each patient (see section 4.8).
Croatian: Stoga bolesnike treba pažljivo nadzirati zbog mogućih promjena u ponašanju, a koristi i rizike nastavka liječenja pažljivo ocijeniti za svakog bolesnika pojedinačno (vidjeti dio 4.8).
English: The primary analysis was performed on the Influenza Positive Population (IPP) comprised of 488 patients.
Croatian: Influenza Positive Population, IPP), koju je činilo 488 bolesnika.
English: Other medicines and Dectova
Croatian: Drugi lijekovi i Dectova
English: This is equivalent to 3.54% of the recommended maximum daily intake of sodium for an adult.
Croatian: To odgovara 3,54% preporučenog maksimalnog dnevnog unosa natrija za odraslu osobu.
English: • If refrigerated, the infusion bag should be removed from the refrigerator and brought up to room temperature before use.
Croatian: • Ako se infuzijska vrećica čuva u hladnjaku, treba je izvaditi iz hladnjaka i pričekati da se ugrije na sobnu temperaturu prije primjene.
English: This means that for scientific reasons it has not been possible to get complete information on this medicine.
Croatian: To znači da zbog znanstvenih razloga nije bilo moguće dobiti potpune informacije o ovom lijeku.
English: There is no evidence that zanamivir is metabolised.
Croatian: Nema dokaza da se zanamivir metabolizira.
English: This being a marketing authorisation under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Croatian: Budući da je ovo odobrenje za stavljanje lijeka u promet u iznimnim okolnostima, sukladno članku 14. stavku 8. Uredbe (EZ) br. 726/2004, nositelj odobrenja dužan je unutar navedenog vremenskog roka provesti sljedeće mjere:
English: What Dectova is and what it is used for
Croatian: Što je Dectova i za što se koristi
English: These symptoms also occur in people with flu who are not being given Dectova.
Croatian: Ti se simptomi javljaju i u osoba oboljelih od gripe koje ne primaju lijek Dectova.
English: In vitro activity
Croatian: Aktivnost in vitro
English: Dectova contains zanamivir, which belongs to a group of medicines called antivirals.
Croatian: Dectova sadrži zanamivir, koji pripada skupini lijekova pod nazivom antivirotici.
English: Influenza can be associated with a variety of neurological and behavioural symptoms.
Croatian: Gripa može biti povezana s nizom različitih neuroloških i bihevioralnih simptoma.
English: If you are given more Dectova than you should
Croatian: Ako primite više lijeka Dectova nego što ste trebali
English: ➔ Tell a doctor or nurse immediately.
Croatian: Odmah o tome obavijestite liječnika ili medicinsku sestru.
English: Eligible patients were not to have had >3 days of prior antiviral treatment.
Croatian: Bolesnici pogodni za sudjelovanje u ispitivanju nisu smjeli prethodno primati antivirusno liječenje > 3 dana.
English: What Dectova looks like and contents of the pack
Croatian: Kako Dectova izgleda i sadržaj pakiranja
English: If any hypersensitivity reaction occurs during infusion of Dectova, the infusion must be stopped immediately and appropriate management should be instituted.
Croatian: Ako tijekom infuzije lijeka Dectova nastupi bilo kakva reakcija preosjetljivosti, infuzija se mora odmah prekinuti i treba uvesti odgovarajuće liječenje.
English: A doctor or nurse will give you Dectova as an infusion (drip) into a vein.
Croatian: Liječnik ili medicinska sestra dat će Vam lijek Dectova u obliku infuzije (dripa) u venu.
English: Dectova should be used in accordance with official guidance.
Croatian: Lijek Dectova treba primjenjivati u skladu sa službenim smjernicama.
English: 6 months to < 6 years
Croatian: 6 mjeseci do < 6 godina
English: The neuraminidase substitution Q136K (A/H1N1 and A/H3N2), confers high level resistance to zanamivir but is selected during adaptation to cell culture and not during treatment.
Croatian: Neuraminidazna supstitucija Q136K (A/H1N1 i A/H3N2) uzrokuje visok stupanj rezistencije na zanamivir, no izdvaja se tijekom prilagodbe staničnoj kulturi, a ne tijekom liječenja.
English: If your kidneys are not working as well as they should, your doctor will decide on the reduced dose for you.
Croatian: Ako Vam bubrezi ne rade kako treba, liječnik će odrediti koliko treba smanjiti dozu.
English: Serious skin and allergic reactions may occur with Dectova, but there isn't enough information to estimate how likely they are.
Croatian: Ozbiljne kožne i alergijske reakcije mogu se javiti kod primjene lijeka Dectova, ali nema dovoljno informacija da bi se procijenila vjerojatnost njihove pojave.
English: So it is not known if Dectova played a part in causing them.
Croatian: Stoga nije poznato ima li Dectova ulogu u njihovu razvoju.
English: Dectova is used to treat severe flu (influenza virus infection).
Croatian: Dectova se koristi za liječenje teške gripe (infekcije virusom gripe).
English: Nervous system disorders convulsions depressed level of consciousness not known
Croatian: Poremećaji živčanog sustava konvulzije smanjena razina svijesti nepoznato
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravne ni neizravne štetne učinke na reprodukciju (vidjeti dio 5.3).
English: Dectova has not been shown to reduce the risk of bacterial complications associated with influenza infection.
Croatian: Nije se pokazalo da Dectova smanjuje rizik od bakterijskih komplikacija povezanih s infekcijom virusom gripe.
English: Phase III study in patients with complicated influenza
Croatian: Ispitivanje faze III u bolesnika s kompliciranom gripom
English: Vials of Dectova are for single use only.
Croatian: Bočice lijeka Dectova namijenjene su samo za jednokratnu uporabu.
English: The pharmacokinetics in elderly subjects was similar to young adult subjects.
Croatian: Farmakokinetika u starijih ispitanika bila je slična onoj u mladih odraslih ispitanika.
English: Table 6: Statistical comparisons of TTCR between the 600 mg zanamivir group and each other group (IPP)
Croatian: Tablica 6: Statističke usporedbe TTCR-a između skupine koja je primala 600 mg zanamivira i svake od ostalih skupina (IPP)
English: The primary endpoint was time to clinical response (TTCR); clinical response was defined as a composite of vital sign stabilisation (temperature, oxygen saturation, respiratory status, heart rate and systolic blood pressure) or hospital discharge.
Croatian: Primarna mjera ishoda bilo je vrijeme do kliničkog odgovora (engl. time to clinical response, TTCR), koji se definirao kao stabilizacija vitalnih znakova (temperature, zasićenosti kisikom, respiratornog statusa, srčanog ritma i sistoličkog krvnog tlaka) ili otpuštanje iz bolnice.
English: • being less alert or not responding to loud sounds or being shaken
Croatian: • smanjena razina budnosti ili izostanak reakcije na glasne zvukove ili protresanje
English: There are limited data from the use of zanamivir in pregnant women.
Croatian: Postoje ograničeni podaci o primjeni zanamivira u trudnica.
English: Treatment with Dectova should commence as soon as possible and usually within 6 days of the onset of symptoms of influenza (see section 5.1).
Croatian: Liječenje lijekom Dectova treba započeti što je prije moguće, obično unutar 6 dana od nastupa simptoma gripe (vidjeti dio 5.1).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, or toxicity to reproduction and development, with the exception of a rat embryofoetal development study (subcutaneous administration).
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala te reproduktivne i razvojne toksičnosti, uz izuzetak ispitivanja učinaka na embriofetalni razvoj u štakora
English: Dectova should not be administered simultaneously with other intravenous medicinal products or prepared in solutions containing glucose or other electrolytes (see section 6.6).
Croatian: Dectova se ne smije primjenjivati istodobno s drugim lijekovima za intravensku primjenu niti pripremati u otopinama koje sadrže glukozu ili druge elektrolite (vidjeti dio 6.6).
English: • Use aseptic techniques throughout preparation of the dose.
Croatian: • Tijekom cijelog postupka pripreme doze mora se koristiti aseptična tehnika.
English: Pharmacotherapeutic group: Antivirals for systemic use, neuraminidase inhibitors ATC code: J05AH01
Croatian: Farmakoterapijska skupina: Antivirotici za sistemsku primjenu, inhibitori neuraminidaze ATK oznaka: J05AH01
English: During treatment with Dectova, changes in behaviour such as confusion and unresponsiveness may occur.
Croatian: Tijekom liječenja lijekom Dectova moguće su promjene u ponašanju, kao što su smetenost i izostanak reakcije na podražaje.
English: • Other anti-viral medicinal products for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient.
Croatian: • kada drugi antivirusni lijekovi za liječenje gripe, uključujući zanamivir za inhalacijsku primjenu, nisu prikladni za određenog bolesnika.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Dectova in one or more subsets of the paediatric population in the treatment and prevention of influenza (see section 4.2 for information on paediatric use).
Croatian: Pedijatrijska populacija Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Dectova u jednoj ili više podskupina pedijatrijske populacije za liječenje i prevenciju gripe (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The plasma protein binding of zanamivir is very low (less than 10%).
Croatian: Zanamivir se u vrlo maloj mjeri vezuje za proteine u plazmi (manje od 10%).
English: Psychiatric disorders abnormal behaviour hallucinations delirium not known
Croatian: Psihijatrijski poremećaji neuobičajeno ponašanje halucinacije delirij nepoznato
English: • The patient's influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/or
Croatian: • kada se zna ili sumnja da je virus gripe kojim je bolesnik zaražen otporan na druge lijekove protiv gripe osim zanamivira, i/ili
English: Pharmacokinetic studies in Thai, Chinese and Japanese healthy subjects did not identify any clinically relevant differences in the pharmacokinetics of zanamivir in these populations compared with Caucasians.
Croatian: Farmakokinetička ispitivanja provedena u tajlandskih, kineskih i japanskih zdravih ispitanika nisu ukazala ni na kakve klinički značajne razlike u farmakokinetici zanamivira u tim populacijama u odnosu na bijelce.
English: What you need to know before you are given Dectova
Croatian: Što morate znati prije nego počnete primati lijek Dectova
English: In the population pharmacokinetic analysis, age had no significant effect on the pharmacokinetics of zanamivir.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, dob nije značajno utjecala na farmakokinetiku zanamivira.
English: For patients receiving continuous renal replacement therapy, the dose should be selected using the appropriate CRRT clearance (CLCRRT in mL/min).
Croatian: Za bolesnike koji primaju kontinuiranu bubrežnu nadomjesnu terapiju dozu treba odabrati na temelju odgovarajućeg CRRT klirensa (CLCRRT u ml/min).
English: There is limited experience of overdose from administration of Dectova.
Croatian: Postoji ograničeno iskustvo s predoziranjem kod primjene lijeka Dectova.
English: Annual reports to be submitted
Croatian: Obvezno je podnositi godišnja izvješća
English: The amount you are given is based on your age, body weight, and the results of your blood tests (to check how well your kidneys are working).
Croatian: Vašoj dobi, tjelesnoj težini i nalazima krvnih pretraga (kojima se provjerava koliko Vam dobro rade bubrezi).
English: If you have any questions on the use of Dectova, ask the doctor or nurse who is giving it you.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom lijeka Dectova, obratite se liječniku ili medicinskoj sestri koja Vam ga daje.
English: Dectova has no or negligible influence on the ability to drive and use machines.
Croatian: Dectova ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Resistance selection during zanamivir treatment is rare.
Croatian: Selekcija rezistentnih sojeva virusa tijekom liječenja zanamivirom je rijetka.
English: Elderly No dose adjustment is required based on age.
Croatian: Nije potrebno prilagođavati dozu na temelju dobi.
English: Zanamivir is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from the plasma membrane of infected cells and promotes virus spread in the respiratory tract.
Croatian: Zanamivir je inhibitor neuraminidaze virusa gripe, enzima koji oslobađa virusne čestice iz plazmatske membrane zaraženih stanica i pospješuje širenje virusa u dišnom sustavu.
English: In adults with normal renal function, the elimination half-life is approximately 2-3 hours.
Croatian: Poluvrijeme eliminacije u odraslih s normalnom bubrežnom funkcijom iznosi približno 2 - 3 sata.
English: • severe allergic reactions, including features such as itchy rash, swelling of the face, throat or tongue, breathing difficulty, light headedness and vomiting.
Croatian: • teške alergijske reakcije, uključujući značajke kao što su osip koji svrbi, oticanje lica, grla ili jezika, otežano disanje, ošamućenost i povraćanje Česte nuspojave
English: As experience is limited, the use of zanamivir in breast-feeding mothers should be considered only if the possible benefit to the mother is thought to outweigh any possible risk to the child.
Croatian: S obzirom na ograničeno iskustvo, primjenu zanamivira u dojilja treba razmotriti samo ako se smatra da moguća korist za majku nadmašuje sve moguće rizike za dijete.
English: There are limited data on zanamivir exposure during concomitant continuous renal replacement therapy and very limited data with dialysis.
Croatian: Postoje ograničeni podaci o izloženosti zanamiviru tijekom istodobne kontinuirane bubrežne nadomjesne terapije i vrlo ograničeni podaci o primjeni kod dijalize.
English: • serum zanamivir levels from patients with complicated influenza (see section 5.1).
Croatian: • podataka o serumskim razinama zanamivira u bolesnika s kompliciranom gripom (vidjeti dio 5.1)
English: As experience is limited, the use of Dectova in pregnancy should only be considered if the possible benefit to the patient is thought to outweigh any possible risk to the foetus.
Croatian: S obzirom na ograničeno iskustvo, primjenu lijeka Dectova u trudnica treba razmotriti samo ako se smatra da moguća korist za bolesnicu nadmašuje sve moguće rizike za plod.
English: Hepatic impairment No dose modification is required (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu (vidjeti dio 5.2).
English: This medicine contains 70.8 mg sodium (main component of cooking/table salt) in each vial.
Croatian: Ovaj lijek sadrži 70,8 mg natrija (glavnog sastojka kuhinjske soli) u jednoj bočici.
English: Any unused solution should be discarded.
Croatian: Sva neupotrijebljena otopina mora se baciti.
English:  6 years to < 18 years
Croatian: ≥ 6 godina do < 18 godina
English: Zanamivir had a significant prophylactic effect against an experimental challenge with influenza A virus as demonstrated by the low infection rate (14% vs. 100% positive serology in placebo group, p <0.005), isolation of virus by viral culture (0% vs. 100% in placebo group, p <0.005), as well as reductions in fever (14% vs. 88% in placebo group, p <0.05), upper respiratory tract illness (0% versus 100% in placebo group, p<0.005) and total symptom scores (1 vs. 44 median score in placebo group, p<0.001).
Croatian: Zanamivir je pokazao značajan profilaktički učinak pri eksperimentalnom izlaganju virusu gripe tipa A, što je dokazano niskom stopom infekcije (pozitivan serološki nalaz: 14% naspram 100% u skupini koja je primala placebo, p < 0,005) i izolacije virusa iz virusne kulture (0% naspram 100% u skupini koja je primala placebo, p < 0,005), kao i smanjenjem stope vrućice (14% naspram 88% u skupini koja je primala placebo, p < 0,05) i bolesti gornjih dišnih putova (0% naspram 100% u skupini koja je primala placebo, p < 0,005) te ukupnih rezultata za simptome (medijan rezultata: 1 naspram 44 u skupini koja je primala placebo, p < 0,001).
English: For patients on intermittent haemodialysis or intermittent peritoneal dialysis, the dose should be given after completion of the dialysis session.
Croatian: U bolesnika koji su na intermitentnoj dijalizi ili intermitentnoj peritonejskoj dijalizi dozu treba primijeniti nakon završetka postupka dijalize.
English: The clinical impact of reduced susceptibility in these viruses is unknown, and the effects of specific substitutions on virus susceptibility to zanamivir may be strain-dependent.
Croatian: Klinički značaj smanjene osjetljivosti tih virusa nije poznat, a učinci specifičnih supstitucija na osjetljivost virusa na zanamivir mogli bi biti ovisni o soju.
English: The H275Y substitution is the most common neuraminidase resistance substitution and is associated with reduced susceptibility to peramivir and oseltamivir.
Croatian: Supstitucija H275Y najčešća je supstitucija neuraminidaze koja uzrokuje rezistenciju, a povezana je sa smanjenom osjetljivošću na peramivir i oseltamivir.
English: Reduced susceptibility to zanamivir is associated with mutations that result in amino acid changes in the viral neuraminidase or viral hemagglutinin or both.
Croatian: Smanjena osjetljivost na zanamivir povezana je s mutacijama koje dovode do promjena aminokiselina u virusnoj neuraminidazi, virusnom hemaglutininu ili oboma.
English: The serum half-life of zanamivir increases to approximately 12-20 hours in patients with severe renal impairment (creatinine clearance < 30 mL/min).
Croatian: Serumski poluvijek zanamivira produljuje se na približno 12 - 20 sati u bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina < 30 ml/min).
English: Zanamivir is not metabolised, therefore no effect of hepatic impairment is expected.
Croatian: Budući da se zanamivir ne metabolizira, ne očekuje se nikakav učinak oštećenja jetrene funkcije.
English: GM %CV
Croatian: GM Raspon GM %CV
English: Other ingredients are sodium chloride and water for injections.
Croatian: Drugi sastojci su natrijev klorid i voda za injekcije.
English: 50 to <80
Croatian: 50 do < 80