FrancophonIA/ELRC3.0 huggingface dataset:
English: Be especially aware of the following when using Xultophy:
Croatian: Kod primjene lijeka Xultophy, posebnu pozornost obratite na sljedeće:
English: If transferring from a long-acting GLP-1 receptor agonist (e.g. onceweekly dosing), the prolonged action should be considered.
Croatian: (npr. doziranje jedanput tjedno), treba uzeti u obzir produljeno djelovanje.
English: Xultophy is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to other oral medicinal products for the treatment of diabetes.
Croatian: radi poboljšanja regulacije glikemije, kao dodatak dijeti i tjelovježbi u kombinaciji s drugim peroralnim lijekovima za liječenje šećerne bolesti.
English: Your pen is designed to be used with NovoTwist or NovoFine disposable needles up to a length of 8 mm and as thin as 32G.
Croatian: NovoFine duljine do 8 mm i ne tanjim od 32 G.
English: Low blood sugar may happen if you:
Croatian: ► Niska razina šećera u krvi (hipoglikemija) Niska razina šećera u krvi može nastupiti ako:
English: When transferring from a GLP-1 receptor agonist, the recommended starting dose of Xultophy is 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) (see section 5.1).
Croatian: 16 odmjernih koraka (16 jedinica degludek inzulina i 0,6 mg liraglutida) (vidjeti dio 5.1).
English: Thyroid adverse events
Croatian: Prošireni MACE događaji
English: 48.7% of patients treated with Xultophy reached the HbA1c target of <7% without confirmed hypoglycaemic episodes.
Croatian: 48,7% bolesnika liječenih lijekom Xultophy postiglo je ciljnu vrijednost HbA1c <7% bez potvrđenih epizoda hipoglikemije, što je bio značajno veći udio od onog zapaženog s degludek inzulinom (15,6%; omjer šansi: 5,57; p<0,0001).
English: Non-cardiovascular death
Croatian: Nesmrtonosni tumori
English: Liraglutide lowered ethinylestradiol and levonorgestrel Cmax by 12 and 13%, respectively, following administration of a single dose of an oral contraceptive product.
Croatian: Nakon primjene jedne doze oralnog kontraceptiva, liraglutid je smanjio Cmax etinilestradiola za 12%, a levonorgestrela za 13%.
English: The rate per patient year of exposure (percentage of patients) of severe hypoglycaemia was 0.01 (1 patient out of 291) for Xultophy and 0.00 (0 patients out of 199) for GLP-1 receptor agonists.
Croatian: (1 bolesnik od 291) za Xultophy i 0,00 (0 bolesnika od 199) za agoniste GLP-1 receptora.
English: Insulin degludec
Croatian: Degludek inzulin
English: If you use more Xultophy than you should, your blood sugar may get low (hypoglycaemia) or you may feel or be sick (nausea or vomiting).
Croatian: Ako primijenite više lijeka Xultophy nego što ste trebali, može doći do pada razine šećera u krvi
English: Xultophy is a pre-filled dial-a-dose pen.
Croatian: Xultophy je napunjena brizgalica s mogućnošću odabira doze.
English: Hypersensitivity to either or both active substances or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na jednu ili obje djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1. 4.4 Posebna upozorenja i mjere opreza pri uporabi Xultophy se ne smije primjenjivati u bolesnika sa šećernom bolešću tipa 1 niti za liječenje dijabetičke ketoacidoze.
English: Anaphylactic reaction
Croatian: Koronarna revaskularizacija
English: • Increased heart rate.
Croatian: • ubrzani puls
English: • Measure your blood sugar if possible and rest. You may need to measure your blood sugar more than once.
Croatian: • Ako možete, izmjerite razinu šećera u krvi i odmorite se.
English: The Liraglutide Effect and Action in Diabetes Evaluation of Cardiovascular Outcome Results (LEADER) trial, was a multicentre, placebo-controlled, double-blind clinical trial.
Croatian: Ispitivanje LEADER (Liraglutide Effect and Action in Diabetes Evaluation of Cardiovascular
English: • Gallstones.
Croatian: • žučni kamenci
English: Cholecystitis
Croatian: Hipoglikemija
English: • Itching.
Croatian: (abdomen).
English: High blood sugar may happen if you:
Croatian: ► Visoka razina šećera u krvi (hiperglikemija) Visoka razina šećera u krvi može nastupiti ako:
English: Hypoglycaemia may develop if a patient is dosed with more Xultophy than required:
Croatian: Ako se primijeni doza lijeka Xultophy veća od potrebne, može se razviti hipoglikemija:
English: Pen scale Pen window
Croatian: Skala na brizgalici
English: Treatment is continued until the patient no longer benefits from it.
Croatian: Terapija se provodi sve do trenutka kada bolesnik od nje više nema koristi.
English: The cancer responded to treatment in 45% of those given Zirabev (162 of 358 patients) and in 45% of those given Avastin (161 of 361).
Croatian: Rak je reagirao na liječenje kod 45 % bolesnika koji su primali lijek Zirabev (162 od 358 bolesnika) te kod 45 % bolesnika koji su primali lijek Avastin (161 od 361).
English: This means that Zirabev is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Croatian: Drugim riječima, Zirabev je vrlo sličan drugom biološkom lijeku („referentnom lijeku”) koji je već odobren u EU-u.
English: The dose, which is given every 2 or 3 weeks, depends on the patient's body weight, the type of cancer being treated and what other cancer medicines are being used.
Croatian: Doza koja se daje svakih dva do tri tjedna ovisi o tjelesnoj težini bolesnika, vrsti raka koji se liječi i drugim lijekovima protiv raka koji se primjenjuju.
English: By attaching to VEGF, Zirabev stops its effect.
Croatian: Vezivanjem na VEGF Zirabev zaustavlja njegovo djelovanje.
English: What measures are being taken to ensure the safe and effective use of Zirabev?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zirabev?
English: Why is Zirabev authorised in the EU?
Croatian: Zašto je Zirabev odobren u EU-u?
English: The first infusion of Zirabev should last 90 minutes, but subsequent infusions may be given more quickly if the first infusion does not cause troublesome side effects.
Croatian: Prva infuzija lijeka Zirabev treba trajati najmanje 90 minuta, no naknadne infuzije mogu se primijeniti brže ako je bolesnik dobro podnio prvu infuziju.
English: Zirabev received a marketing authorisation valid throughout the EU on 14 February 2019 Further information on Zirabev can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zirabev.
Croatian: Više informacija o lijeku Zirabev nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/zirabev.
English: What is Zirabev and what is it used for?
Croatian: Što je Zirabev i za što se primjenjuje?
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Zirabev has a highly similar structure, purity and biological activity to Avastin and is distributed in the body in the same way.
Croatian: Europska agencija za lijekove zaključila je da, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Zirabev ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i lijek Avastin te se u tijelu raspoređuje na isti način.
English: Zirabev is used in combination with other cancer medicines, depending on the nature of any previous treatments or the presence of mutations (genetic changes) in the cancer that affect how well particular medicines work.
Croatian: Lijek Zirabev primjenjuje se u kombinaciji s drugim lijekovima protiv raka, ovisno o prirodi prethodnih terapija ili prisutnosti mutacija (genetskih promjena) u tkivu raka koje utječu na djelotvornost određenih lijekova.
English: The most serious side effects are gastrointestinal perforation (hole in the gut wall), haemorrhage (bleeding) and arterial thromboembolism (blood clots in the arteries).
Croatian: Najčešće ozbiljne nuspojave su gastrointestinalna perforacija (rupa u stijenci crijeva), hemoragija (krvarenje) i arterijski tromboembolizam (krvni ugrušci u arterijama).
English: Zirabev must not be used in people who are hypersensitive (allergic) to bevacizumab or any of the other ingredients, to Chinese hamster ovary cell products or other recombinant antibodies.
Croatian: Zirabev se ne smije koristiti u osoba koje su preosjetljive (alergične) na bevacizumab ili bilo koji drugi sastojak lijeka, na proizvode pripremljene od jajnih stanica kineskog hrčka ili druga rekombinantna protutijela.
English: Zirabev is a cancer medicine that is used to treat adults with the following cancers:
Croatian: Zirabev je lijek protiv raka koji se primjenjuje za liječenje odraslih osoba sa sljedećim vrstama raka:
English: What are the risks associated with Zirabev?
Croatian: Koji su rizici povezani s lijekom Zirabev ?
English: In addition, a study involving 719 patients with advanced non-small cell lung cancer showed that Zirabev was as effective as Avastin when given with the cancer medicines carboplatin and paclitaxel.
Croatian: Nadalje, ispitivanje koje je uključivalo 719 bolesnika s uznapredovalim rakom nemalih stanica pluća pokazalo je da je lijek Zirabev jednako djelotvoran kao i Avastin kada se primjenjuje zajedno s lijekovima za liječenje raka karboplatinom i paklitakselom.
English: Because Zirabev is a biosimilar medicine, the studies on effectiveness and safety of bevacizumab carried out with Avastin do not all need to be repeated for Zirabev.
Croatian: Budući da je lijek Zirabev biosličan lijek, ispitivanja djelotvornosti i sigurnosti bevacizumaba provedena za lijek Avastin nije potrebno ponavljati za lijek Zirabev.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zirabev have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Zirabev nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Side effects reported with Zirabev are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Zirabev pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: An overview of Zirabev and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Zirabev i zašto je odobren u EU-u
English: The reference medicine for Zirabev is Avastin.
Croatian: Referentni lijek za lijek Zirabev je Avastin.
English: The safety of Zirabev has been evaluated, and on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine Avastin.
Croatian: Ocijenjena je sigurnost primjene lijeka Zirabev i na temelju svih provedenih ispitivanja nuspojave lijeka smatraju se usporedivima s onima za referentni lijek Avastin.
English: Other information about Zirabev
Croatian: Ostale informacije o lijeku Zirabev
English: The active substance in Zirabev, bevacizumab, is a monoclonal antibody (a type of protein) that has been designed to attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and encourages the growth of new blood vessels.
Croatian: Djelatna tvar lijeka Zirabev, bevacizumab, monoklonsko je protutijelo (vrsta bjelančevine) koje se veže na krvožilni endotelni čimbenik rasta (VEGF), bjelančevinu koja cirkulira u krvi i potiče rast novih krvnih žila.
English: Laboratory studies comparing Zirabev with Avastin have shown that the active substance in Zirabev is highly similar to that in Avastin in terms of structure, purity and biological activity.
Croatian: Laboratorijska ispitivanja u kojima su uspoređivani lijekovi Zirabev i Avastin pokazala su da je djelatna tvar u lijeku Zirabev vrlo slična djelatnoj tvari u lijeku Avastin u pogledu strukture, čistoće i biološke aktivnosti.
English: Zirabev can be used unless the cancer originates in particular cells called squamous cells;
Croatian: Zirabev se može primjenjivati ako se rak nije inicijalno pojavio u određenim stanicama naziva skvamozne stanice.
English: • breast cancer that has spread to other parts of the body;
Croatian: • rakom dojke koji se proširio na druge dijelove tijela;
English: Therefore, the Agency's view was that, as for Avastin, the benefits of Zirabev outweigh the identified risks and it can be authorised for use in the EU.
Croatian: Agencije da, kao i kod lijeka Avastin, koristi od lijeka Zirabev nadmašuju identificirane rizike te da se lijek može odobriti za primjenu u EU-u.
English: • cancer of the cervix (the neck of the womb) that has persisted or come back after treatment, or spread to other parts of the body.
Croatian: • rakom cerviksa (grlića maternice) koji je perzistentan, vratio se nakon terapije ili se proširio na druge dijelove tijela.
English: Zirabev can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the use of cancer medicines.
Croatian: Lijek Zirabev izdaje se samo na liječnički recept, a liječenje mora nadzirati liječnik s iskustvom u primjeni lijekova protiv raka.
English: For more information about using Zirabev, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Zirabev pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: These data were considered sufficient to conclude that Zirabev will behave in the same way as Avastin in terms of effectiveness and safety in its authorised uses.
Croatian: Svi ti podatci smatraju se dovoljnima za donošenje zaključka da će lijek Zirabev za odobrene indikacije djelovati na isti način kao i lijek Avastin u pogledu učinkovitosti i sigurnosti primjene.
English: As for all medicines, data on the use of Zirabev are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Zirabev kontinuirano se prate.
English: In addition, a study in non-small cell lung cancer has shown that Zirabev's effectiveness is equivalent to that of Avastin in this condition.
Croatian: Osim toga, ispitivanje na raku pluća nemalih stanica pokazalo je da je djelotvornost lijeka Zirabev jednaka onoj lijeka Avastin kod ove bolesti.
English: • cancer of the colon (large bowel) or the rectum (the last section of the bowel), when it has spread to other parts of the body;
Croatian: • rakom debelog crijeva ili rektuma (zadnji dio crijeva) koji se proširio na druge dijelove tijela;
English: Zirabev contains the active substance bevacizumab and it is a ‘biosimilar medicine'.
Croatian: Lijek Zirabev sadrži djelatnu tvar bevacizumab te je „biosličan lijek”.
English: How does Zirabev work?
Croatian: Kako djeluje Zirabev ?
English: Studies have also shown that giving Zirabev produces similar levels of the active substance in the body to giving Avastin.
Croatian: Ispitivanja su utvrdila i da se primjenom lijeka Zirabev stvaraju slične razine djelatne tvari u tijelu kao i primjenom lijeka Avastin.
English: What benefits of Zirabev have been shown in studies?
Croatian: Koje su koristi od lijeka Zirabev utvrđene u ispitivanjima?
English: • cancer of the kidney (renal cell carcinoma) that is advanced or has spread elsewhere;
Croatian: • rakom bubrega (karcinomom bubrežnih stanica) koji je uznapredovao ili se proširio na druge dijelove tijela;
English: How is Zirabev used?
Croatian: Kako se Zirabev primjenjuje?
English: • a lung cancer called non-small cell lung cancer when it is advanced or has spread or come back,
Croatian: • rakom pluća nemalih stanica koji je uznapredovao, proširio se ili vratio te ga nije moguće liječiti kirurškim zahvatom.
English: For the full list of side effects with Zirabev, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Zirabev potražite u uputi o lijeku.
English: Zirabev is given by infusion (drip) into a vein.
Croatian: Lijek Zirabev primjenjuje se intravenskom infuzijom.
English: Immediate Packaging Pack size
Croatian: Unutarnje pakiranje Veličina pakiranja
English: Strength
Croatian: Silodozzin Recordati
English: Pharmaceutical Form Route of Administration
Croatian: Broj (EU) odobrenja Zaštićeno ime Jačina Farmaceutski oblik Put primjene
English: 4 ampoules
Croatian: 4 ampule
English: 5 mg/ml
Croatian: 2ml
English: Invented name Strength Pharmaceutical form Route of administration Packaging Content (concentration) Package size EU/1/04/284/001 Pedea
Croatian: EU/1/04/284/001 Pedea
English: Solution for injection Intravenous use
Croatian: Doza Farmaceutski oblik Put primjene
English: Ampoule (glass) 2 ml
Croatian: 5 mg/ml otopina za injekciju Intravenska primjena Ampule (staklo)
English: Samples from treated animals were collected at 4, 8, 12, 16, 20, 24 and 28 days after the end of treatment.
Croatian: Uzorci iz liječenih životinja prikupljeni su 4, 8, 12, 16, 20, 24 i 28 dana nakon završetka liječenja.
English: • A new residue depletion study is required regardless of whether the dosing regimen has changed or not.
Croatian: • Potrebno je provesti novo ispitivanje o razgradnji rezidua bez obzira na to je li se režim doziranja promijenio ili ne.
English: The reference product is authorised in Belgium since 1985.
Croatian: Referentni VMP odobren je u Belgiji od 1985.
English: Ceva Saúde Animal - Produtos Farmacêuticos e Imunológicos, Lda.
Croatian: Ceva Saúde AnimalProdutos Farmacêuticos e Imunológicos, Lda.
English: Belgium therefore considered that it is necessary to refer the matter to the CVMP in the interests of animal health and protecting consumer safety in the Union.
Croatian: Belgija je stoga smatrala da je predmet potrebno uputiti CVMP-u u interesu zaštite zdravlja životinja i sigurnosti potrošača u Uniji.
English: It may be administered by parenteral route.
Croatian: Može se primjenjivati parenteralno.
English: Justification of the dose and the duration of treatment are required.
Croatian: Potrebno je navesti obrazloženje doze i trajanja liječenja.
English: The target species are pigs and the route of administration is intramuscular.
Croatian: Ciljna vrsta su svinje, a put primjene je intramuskularno.
English: Therefore a withdrawal period cannot be reliably estimated.
Croatian: Stoga se razdoblje karencije ne može pouzdano procijeniti.
English: While target animal safety was not in the scope of this referral, there are no known adverse events in pigs.
Croatian: Iako sigurnost ciljne životinje nije obuhvaćena ovim arbitražnim postupkom, nema poznatih štetnih događaja u svinja.
English: The mechanism of action of paromomycin has been well described as well as the mechanisms of antimicrobial resistance to paromomycin.
Croatian: Mehanizam djelovanja paromomicina dobro je opisan, kao i mehanizmi antimikrobne rezistencije na paromomicin.
English: Animal species
Croatian: Životinjs ka vrsta
English: In conclusion, the CVMP considered that the efficacy of these veterinary medicinal products was not supported for any indication and posology.
Croatian: Zaključno, CVMP je smatrao da djelotvornost tih veterinarsko-medicinskih proizvoda nije potkrijepljena ni za jednu indikaciju i doziranje.
English: The sampling size in target strains was not optimal to distinguish between wild type and a population with acquired resistance determinants.
Croatian: Veličina uzorka ciljnih sojeva nije bila optimalna za utvrđivanje razlike između sojeva divljeg tipa i populacije koja je stekla determinante otpornosti.
English: The most relevant tissues for the presence of paromomycin residue were muscle at the injection site and kidney.
Croatian: Najrelevantnija tkiva za prisutnost rezidua paromomicina bili su mišić na mjestu primjene injekcije i bubrezi.
English: The product showed no accumulation during the treatment period (5 days).
Croatian: Nije uočeno nakupljanje VMP-a tijekom razdoblja liječenja (pet dana).
English: Luxembourg Ceva Sante Animale NV Metrologielaan 6
Croatian: Luksemburg Ceva Sante Animale NV Metrologielaan 6
English: Moreover, product administration at an inappropriate dose poses an added risk of resistance development.
Croatian: Štoviše, primjena VMP-a u neprimjerenoj dozi predstavlja dodatan rizik od razvoja rezistencije.
English: Hence, the veterinary medicinal product could be expected to be effective against E. coli as shown by the sensitivity results of a recent study, where 76% of the strains would be sensitive.
Croatian: Stoga se može očekivati da će veterinarsko-medicinski proizvod biti učinkovit protiv bakterije E. coli, što pokazuju i rezultati osjetljivosti nedavno provedenog ispitivanja prema kojima bi 76 % sojeva bilo osjetljivo.
English: Paromomycin has broad spectrum activity against numerous Gram-positive and Gram-negative bacteria and acts in a concentrationdependent manner.
Croatian: Paromomicin ima širok spektar djelovanja protiv brojnih gram-pozitivnih i gram-negativnih bakterija i djeluje ovisno o koncentraciji.
English: The withdrawal period should be based on robust and complete data (animal phase and validation of the analytical method) in accordance with the guidelines in force.
Croatian: Razdoblje karencije treba se temeljiti na pouzdanim i cjelovitim podatcima (faza testiranja životinja i potvrda analitičke metode) u skladu s važećim smjernicama.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, marketing authorisation holders in the Member States
Croatian: Popis naziva, farmaceutskog oblika, jačine veterinarskomedicinskih proizvoda, životinjskih vrsta, putova primjene, nositelja odobrenja za stavljanje VMP-a u promet u državama članicama
English: Within this referral procedure, one of the marketing authorisation holders proposed the following indications as an amendment to the current indications:
Croatian: U okviru ovog arbitražnog postupka, jedan od nositelja odobrenja za stavljanje VMP-a u promet predložio je izmjenu postojećih indikacija sljedećim indikacijama:
English: Muscle of injection site is not the most reliable tissue for withdrawal time calculation, as it is often characterised by a high variability in residues levels, confirmed also in this case by the limited number of samples with concentrations above limit of quantification (2/4 on Day 12).
Croatian: Mišić na mjestu primjene injekcije nije najpouzdanije tkivo za izračunavanje razdoblja karencije jer je često obilježen visokom varijabilnošću razina rezidua, što u ovom slučaju potvrđuje i ograničeni broj uzoraka s koncentracijom iznad granice kvantifikacije (2/4 na 12. dan).
English: The withdrawal period was determined in animals with a mean weight of 37.2 kg (range of 32 to 42.8 kg) treated according to the recommended posology at the longest duration of treatment.
Croatian: Razdoblje karencije utvrđeno je u životinja sa srednjom vrijednošću tjelesne težine od 37,2 kg (raspon od 32 do 42,8 kg) liječenih u skladu s preporučenim doziranjem u najduljem trajanju liječenja.
English: However, there are no pre-clinical and clinical data supporting the indication for the treatment of MMA in sows.
Croatian: Međutim, nema pretkliničkih i kliničkih podataka koji podupiru indikaciju za liječenje sindroma MMA u krmača.
English: In order to justify efficacy of the product, susceptibility data were provided for E. coli and A. pleuropneumoniae and a pharmacokinetics/pharmacodynamics (PK/PD) analysis was performed.
Croatian: Kako bi se opravdala djelotvornost VMP-a, dostavljeni su podatci o osjetljivosti za bakterije E. coli i A. pleuropneumoniae te je provedena analiza farmakokinetike i farmakodinamike (PK/PD).
English: • If efficacy is demonstrated for a different dosage regimen compared to the authorised dosage regimen at the time of marketing authorisation suspension, the following points should be reviewed from a safety point of view:
Croatian: • Ako se dokaže djelotvornost drugačijeg režima doziranja u usporedbi s režimom doziranja koji je bio odobren u vrijeme privremenog oduzimanja odobrenja za stavljanje VMP-a promet, potrebno je s obzirom na sigurnost preispitati sljedeće točke:
English: Belgium Ceva Sante Animale NV Metrologielaan 6
Croatian: Ceva Sante Animale NV Metrologielaan 6