FrancophonIA/ELRC3.0 huggingface dataset:
English: Exposure to corifollitropin alfa increases proportionally with dose within the range of 60 micrograms to 240 micrograms.
Croatian: Izloženost korifolitropinu alfa povećava se proporcionalno dozi, u rasponu od 60 mikrograma do 240 mikrograma.
English: The chance of having this complication can be reduced by carefully monitoring the number of maturing follicles.
Croatian: Vjerojatnost da dobijete ovu komplikaciju može se smanjiti pažljivim nadzorom broja sazrijevajućih folikula.
English: Distribution, metabolism and elimination of corifollitropin alfa are very similar to other gonadotropins, such as FSH, hCG and LH.
Croatian: Distribucija, metabolizam i eliminacija korifolitropina alfa vrlo su slični ostalim gonadotropinima poput FSH, hCG i LH.
English: In animal studies reproductive toxicity has been observed (see preclinical safety data in section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost (vidjeti nekliničke podatke o sigurnosti primjene u dijelu 5.3).
English: In each case, these antibodies were non-neutralizing and did not interfere with the response to stimulation or the normal physiologic responses of the Hypothalamic-Pituitary-Ovarian (HPO) axis.
Croatian: U svakom slučaju, ta protutijela nisu bila neutralizirajuća i nisu ometala odgovor na stimulaciju ili normalne fiziološke odgovore osi hipotalamus-hipofiza-jajnici.
English: More than one injection of Elonva within one treatment cycle or too high a dose of Elonva and/or (rec)FSH may increase the risk of OHSS (see OHSS in section 4.4.
Croatian: Više od jedne Elonva injekcije unutar jednog ciklusa ili previsoke doze lijeka Elonva i/ili (rek)FSH mogu povećati rizik od OHSS-a (vidjeti OHSS u dijelu 4.4).
English: Subcutaneous injection of Elonva may be carried out by the woman herself or her partner, provided that proper instructions are given by the physician.
Croatian: Supkutanu injekciju lijeka Elonva može primijeniti sama žena ili njezin partner ako im je liječnik dao odgovarajuće upute.
English: In case of an excessive ovarian response, see the recommendations given in section 4.4 in order to reduce the risk for developing ovarian hyperstimulation syndrome (OHSS).
Croatian: U slučaju prekomjernog odgovora jajnika, pogledajte preporuke u dijelu 4.4 kako bi se smanjio rizik za razvoj sindroma hiperstimulacije jajnika (engl. ovarian hyperstimulation syndrome, OHSS).
English: Multiple pregnancies carry an increased health risk for both the mother and her babies.
Croatian: Višeplodne trudnoće nose povećan zdravstveni rizik i za majku i za njenu novorođenčad.
English: This leaflet was last revised in Month YYYY.
Croatian: Ova uputa je zadnji puta revidirana u mjesec GGGG.
English: If you use more Elonva or (rec)FSH than you should If you think you have used more Elonva or (rec)FSH than you should, contact your doctor immediately.
Croatian: Ako primijenite više lijeka Elonva ili (rek)FSH-a nego što ste trebali Ako mislite da ste primijenili više lijeka Elonva ili (rek)FSH-a nego što ste trebali, odmah se javite liječniku.
English: Two of these four women became pregnant during the same treatment cycle in which antibodies were detected, suggesting that the presence of non-neutralizing antibodies after stimulation with Elonva is not clinically relevant.
Croatian: Dvije od tih četiri žena zatrudnjele su tijekom istog ciklusa liječenja u kojem su otkrivena protutijela, što ukazuje na to da prisutnost ne-neutralizirajućih protutijela nakon stimulacije lijekom Elonva nije klinički značajno.
English: You may use Elonva only once during the same treatment cycle, otherwise, the chance of having OHSS may increase.
Croatian: Lijek Elonva smijete koristiti samo jedanput unutar istog ciklusa liječenja, jer se inače može povećati vjerojatnost razvoja OHSS-a.
English: In these clinical trials, the safety profile of a single injection with Elonva was comparable to daily injections with recFSH.
Croatian: U ovim kliničkim ispitivanjima, sigurnosni profil jedne injekcije lijeka Elonva bio je usporediv s dnevnim injekcijama rekFSH-a.
English: In rare cases, severe OHSS may be life-threatening.
Croatian: U rijetkim slučajevima, teški OHSS može biti opasan po život.
English: After a single subcutaneous injection of Elonva, the maximum serum concentration of corifollitropin alfa is 4.24 ng/mL (2.49-7.21 ng/mL
Croatian: Nakon jedne supkutane injekcije lijeka Elonva, maksimalna serumska koncentracija korifolitropina alfa iznosi 4,24 ng/ml (2,49-7,21 ng/ml
English: Talk to your doctor before using Elonva.
Croatian: Obratite se svom liječniku prije nego primijenite lijek Elonva.
English: To check the effects of treatment, your doctor will do ultrasound scans of your ovaries.
Croatian: Kako bi provjerio učinke liječenja, liječnik će Vam napraviti ultrazvučni pregled jajnika.
English: Reproduction toxicology studies in rats and rabbits indicated that corifollitropin alfa does not adversely affect fertility.
Croatian: Ispitivanja reproduktivne toksičnosti na štakorima i kunićima pokazala su da korifolitropin alfa ne utječe štetno na plodnost.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Elonva in one or more subsets of the paediatric population in hypogonadotrophic hypogonadism (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Elonva u jednoj ili više podskupina pedijatrijske populacije u hipogonadotropnom hipogonadizmu (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Make a note of when you start storing the product out of the refrigerator, and use it within one month of that date.
Croatian: Zabilježite kada ste lijek počeli čuvati izvan hladnjaka te ga iskoristite unutar mjesec dana od zabilježenog datuma.
English: Do not inject Elonva into a muscle.
Croatian: Nemojte injicirati lijek Elonva u mišić.
English: In women with generally recognized risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia, treatment with gonadotropins may further increase this risk.
Croatian: U žena s opće poznatim faktorima rizika za tromboembolijske događaje, poput pozitivne osobne ili obiteljske anamneze, jake pretilosti ili trombofilije, liječenje gonadotropinima može dodatno povećati ovaj rizik.
English: The recommended doses of Elonva have only been established in a treatment cycle with a GnRH antagonist that was administered from stimulation day 5 or day 6 onwards (see also sections 4.1, 4.4, and 5.1).
Croatian: Preporučene doze lijeka Elonva ustanovljene su samo u ciklusu liječenja s antagonistom GnRH koji se primjenjivao od 5. ili 6. dana stimulacije nadalje (vidjeti također dijelove 4.1, 4.4, i 5.1).
English:  Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Severe OHSS may be life-threatening.
Croatian: Teški OHSS može ugrožavati život.
English: Multiple pregnancies and specific characteristics of couples with fertility problems (e.g., a woman's age, certain sperm problems, genetic background of both parents) may also be associated with an increased chance of birth defects.
Croatian: Višeplodne trudnoće i specifične osobine parova koji imaju problem neplodnosti (na primjer dob žene, određeni problemi sa spermom, genetska podloga oba roditelja) mogu također biti povezani s povećanim rizikom od urođenih nedostataka ploda.
English: The woman and her partner should be advised of the potential risks for the mother (pregnancy and delivery complications) and the neonate (low birth weight) before starting treatment.
Croatian: Prije početka liječenja žene i njihove partnere treba upozoriti na potencijalne rizike za majku (trudnoća i komplikacije pri porodu) i novorođenče (mala porođajna težina).
English: This is thought to be due to differences in parental characteristics (e.g., maternal age, sperm characteristics) and the higher incidence of multiple pregnancies.
Croatian: Smatra se da su razlog tome razlike u osobinama roditelja (npr. dob majke, osobine sperme) kao i veća incidencija višeplodnih trudnoća.
English: Driving and using machines Elonva may cause dizziness.
Croatian: Upravljanje vozilima i strojevima Elonva može uzrokovati omaglicu.
English: The number of oocytes retrieved was a key secondary efficacy endpoint.
Croatian: Broj dobivenih oocita bio je ključni sekundarni ishod djelotvornosti.
English: OHSS may be caused by administration of hCG and by pregnancy (endogenous hCG).
Croatian: OHSS može biti uzrokovan primjenom hCG-a kao i trudnoćom (endogeni hCG).
English: Intravascular thrombosis, which may originate in venous or arterial vessels, can result in reduced blood flow to vital organs or the extremities.
Croatian: Intravaskularna tromboza, koja može nastati u venama ili arterijama, može dovesti do smanjenog dotoka krvi u vitalne organe ili ekstremitete.
English: - Swab the injection site (the area just below your belly button) with a disinfectant (for example, alcohol) to remove any surface bacteria.
Croatian: - Očistite mjesto primjene injekcije (područje kože neposredno ispod pupka) dezinfekcijskim sredstvom (na primjer, alkoholom) kako biste uklonili bakterije s površine.
English: Elonva contains the active ingredient corifollitropin alfa and belongs to the group of medicines called gonadotropic hormones.
Croatian: Elonva sadrži djelatnu tvar korifolitropin alfa i pripada skupini lijekova koji se zovu gonadotropni hormoni.
English: Treatment with a GnRH antagonist should be started on stimulation day 5 or day 6 depending on the ovarian response, i.e. the number and size of growing follicles.
Croatian: Liječenje antagonistom GnRH treba započeti 5. ili 6. dana stimulacije, ovisno o odgovoru jajnika, tj. o broju i veličini folikula koji se razvijaju.
English: Alanine aminotransferase increased, aspartate aminotransferase increased
Croatian: Pretrage manje često povišena alanin aminotransferaza, povišena aspartat aminotransferaza
English: Corifollitropin alfa is designed as a sustained follicle stimulant with the same pharmacodynamic profile as (rec)FSH, but with a markedly prolonged duration of FSH activity.
Croatian: Korifolitropin alfa dizajniran je kao kontinuirani stimulator folikula istog farmakodinamičkog profila kao i (rek)FSH, ali s izrazito produljenim trajanjem aktivnosti FSH-a.
English: Please discuss this with your doctor, before starting treatment, especially if: - you know you already have an increased chance of having a thrombosis - you, or anyone in your immediate family, have ever had a thrombosis - you are severely overweight.
Croatian: Molimo da o tome razgovarate s liječnikom prije početka liječenja, a osobito: - ako znate da već imate povećan rizik za razvoj tromboze, - ako ste Vi ili netko u Vašoj užoj obitelji ikad imali trombozu, - ako ste vrlo pretili.
English: The relevance of these findings for the clinical use of Elonva is limited.
Croatian: Značaj ovih nalaza za primjenu lijeka Elonva u kliničkoj praksi je ograničen.
English: 1) and a clearance of 0.13 L/h
Croatian: 1), a klirens je 0,13 l/h
English: The pH may have been adjusted with sodium hydroxide and/or hydrochloric acid.
Croatian: Za podešavanje pH može se koristiti natrijev hidroksid i/ili kloridna kiselina.
English: Due to the long elimination half-life, after administration of the recommended dose, serum concentrations of corifollitropin alfa are sufficient to sustain multiple follicular growth for an entire week.
Croatian: Zbog dugog poluvijeka eliminacije, nakon primjene preporučene doze, serumska koncentracija korifolitropina alfa dovoljna je za održavanje rasta većeg broja folikula tijekom cijelog tjedna.
English: Of the 2,511 women treated with Elonva who were evaluated for the formation of post-treatment antibodies, four (0.16%) had evidence of antibody formation, including three who had been exposed once to Elonva and one who had been exposed twice to Elonva.
Croatian: Od 2511 žena liječenih lijekom Elonva u kojih se procijenilo stvaranje protutijela nakon liječenja, u njih četiri (0,16%) dokazano je stvaranje protutijela, uključujući tri koje su bile izložene lijeku Elonva jedanput i jednu koja je bila izložena lijeku Elonva dvaput.
English: Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.
Croatian: Oštećenje jajnika zbog smanjene opskrbe krvlju može se ograničiti ranom dijagnozom i hitnim uklanjanjem torzije.
English: One of these gonadotropic hormones is follicle-stimulating hormone (FSH), which is needed in women for the growth and development of follicles (small round sacs in your ovaries that contain the eggs).
Croatian: Jedan od tih gonadotropnih hormona je hormon koji stimulira folikule (FSH), koji je potreban u žena za rast i razvoj folikula (malih okruglih vrećica u jajnicima koje sadrže jajne stanice).
English: Corifollitropin alfa exposure after a single subcutaneous injection is 665 hours*ng/mL (AUC, 426-1,037 hours*ng/mL
Croatian: Izloženost korifolitropinu alfa nakon jedne supkutane injekcije traje 665 sati*ng/ml (AUC, 426-1037 sati*ng/ml
English: The most frequently reported adverse reactions during treatment with Elonva in clinical trials (N=2,397) are pelvic discomfort (6.0%), OHSS (4.3%, see also section 4.4), headache (4.0%), pelvic pain (2.9%), nausea (2.3%), fatigue (1.5%), and breast tenderness (1.3%).
Croatian: Najčešće nuspojave za vrijeme liječenja lijekom Elonva prijavljene u kliničkim ispitivanjima (N=2397) su nelagoda u zdjelici (6,0%), OHSS (4,3%, također vidjeti dio 4.4), glavobolja (4,0%), bol u zdjelici (2,9%), mučnina (2,3%), umor (1,5%) i osjetljivost dojki (1,3%).
English: After absorption into the blood, corifollitropin alfa is distributed mainly to the ovaries and the kidneys.
Croatian: Nakon apsorpcije u krv, korifolitropin alfa većinom se distribuira u jajnike i bubrege.
English: Stimulation day 8:
Croatian: 8. dan stimulacije:
English: No interaction studies with Elonva and other medicines have been performed.
Croatian: Nisu provedena ispitivanja interakcija lijeka Elonva s drugim lijekovima.
English: Congenital malformations reported in infants born after a frozen-thawed embryo transfer (FTET) cycle
Croatian: Kongenitalne malformacije prijavljene u dojenčadi rođene nakon ciklusa s odmrznutim embrijima (FTET)
English: The table below displays the main adverse reactions in women treated with Elonva in clinical trials and post-marketing surveillance according to system organ class and frequency; 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), very rare (< 1/10,000), and not known (cannot be estimated from available data).
Croatian: U sljedećoj tablici navedene su glavne nuspojave zabilježene u žena liječenih lijekom Elonva u kliničkim ispitivanjima i praćenjem nakon stavljanja lijeka u promet, razvrstane prema klasifikaciji organskih sustava i učestalosti pojavljivanja; vrlo često (≥ 1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The syringe is packed together with a sterile injection needle.
Croatian: Štrcaljka je pakirana zajedno sa sterilnom iglom za injekciju.
English: Mean number of oocytes Difference [95% CI]
Croatian: Srednja vrijednost broja oocita Razlika [95% CI]
English: Storage by the pharmacist Store in a refrigerator.
Croatian: Čuvanje u ljekarni Čuvati u hladnjaku.
English: Do not use this medicine after the expiry date which is stated on the label and outer carton after “EXP” (expiry date).
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i na kutiji iza oznake "EXP".
English: No studies on the ability to drive and use machines have been performed.
Croatian: Nisu provedena ispitivanja utjecaja na sposobnost upravljanja vozilima i rada sa strojevima.
English: Women with known risk factors for a high ovarian response may be especially prone to the development of OHSS following treatment with Elonva.
Croatian: Žene s poznatim faktorima rizika za pojačan odgovor jajnika mogu biti posebno sklone razvoju OHSS-a nakon liječenja lijekom Elonva.
English: Do not use Elonva if the solution is not clear.
Croatian: Ne koristiti lijek Elonva ako otopina nije bistra.
English: Ovarian torsion may be related to other conditions, such as OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, and previous or current ovarian cysts.
Croatian: Torzija jajnika može biti povezana s drugim stanjima, kao što su OHSS, trudnoća, prethodni abdominalni kirurški zahvat, torzija jajnika u anamnezi te prethodne ili sadašnje ciste jajnika.
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije manje često bol pri postupku
English: In women undergoing ART procedures the risk of multiple pregnancy is mainly related to the number of embryos transferred.
Croatian: Kod žena u postupku medicinski potpomognute oplodnje rizik od višeplodnih trudnoća većinom je vezan uz broj transferiranih embrija.
English: Your doctor will do ultrasound scans of your ovaries to carefully monitor the number of maturing follicles.
Croatian: Liječnik će Vam napraviti nekoliko pregleda jajnika ultrazvukom kako bi pažljivo nadzirao broj sazrijevajućih folikula.
English:  Primary ovarian failure.
Croatian: • Primarno zatajenje jajnika.
English: One pre-filled syringe is available in a single pack.
Croatian: Jedna napunjena štrcaljka dostupna je u pojedinačnom pakiranju.
English: Women older than 36 years of age who weighed less than 50 kilograms were not studied.
Croatian: Žene starije od 36 godina tjelesne težine manje od 50 kilograma nisu bile ispitane.
English: Ovarian overstimulation may develop into a medical condition called ovarian hyperstimulation syndrome (OHSS), which can be a serious medical problem.
Croatian: Pretjerana stimulacija jajnika može se razviti u zdravstveno stanje koje se zove sindrom hiperstimulacije jajnika (OHSS) i može predstavljati ozbiljan zdravstveni problem.
English: Do not inject Elonva without talking with your doctor.
Croatian: Nemojte injicirati lijek Elonva, a da o tome niste razgovarali s liječnikom.
English: The GnRH antagonist is used to prevent premature Luteinising Hormone (LH) surges.
Croatian: Antagonist GnRH koristi se za sprječavanje prijevremenog naglog porasta razine luteinizirajućeg hormona (LH).
English: The concurrent determination of serum oestradiol levels may also be useful.
Croatian: Istodobno određivanje razine estradiola u serumu također može biti korisno.
English: Contact your doctor without delay if you have pain in the stomach (abdomen) or any of the other symptoms of ovarian hyperstimulation, even if they occur some days after the injection has been given.
Croatian: Odmah se obratite svom liječniku ako imate bol u trbuhu (abdomenu) ili neki drugi simptom pretjerane stimulacije jajnika, čak i ako se javi više dana nakon primjene injekcije.
English: Elonva must be injected under the skin (subcutaneously) into a skin fold (that you pinch between your thumb and index finger), preferably just below the navel.
Croatian: Elonva se mora injicirati pod kožu (supkutano), u kožni nabor (koji uhvatite palcem i kažiprstom), najbolje odmah ispod pupka.
English: Stimulation day 1:
Croatian: 1. dan stimulacije:
English: You should not use Elonva if you are already pregnant, or think that you might be pregnant, or if you are breast-feeding.
Croatian: Ne smijete primijeniti lijek Elonva ako ste trudni ili mislite da biste mogli biti trudni ili ako dojite.
English: Elonva 150 µg recFSH 300 IU n N % n N % n N % n N %
Croatian: Elonva 150 µg rekFSH 300 IU n N % n N % n N % n N %
English: Package leaflet: Information for the user
Croatian: Uputa o lijeku: Informacije za korisnicu
English: Clear and colourless aqueous solution.
Croatian: Bistra i bezbojna vodena otopina.
English: This may be due to cross-reactivity of hCG pregnancy tests with the carboxy-terminal peptide of the beta subunit of Elonva.
Croatian: To može biti posljedica križne reaktivnosti nekih hCG testova za trudnoću s peptidom na karboksilnom kraju beta podjedinice lijeka Elonva.
English:  Malformations of the reproductive organs incompatible with pregnancy.
Croatian: • Malformacije spolnih organa nespojive s trudnoćom.
English: o A basal antral follicle count > 20.
Croatian: o Bazalni broj antralnih folikula >20.
English: What Elonva contains - The active substance is corifollitropin alfa.
Croatian: Što Elonva sadrži - Djelatna tvar je korifolitropin alfa.
English: If you forget to use Elonva
Croatian: Ako ste zaboravili primijeniti lijek Elonva
English: IVF involves collecting the eggs from the ovary, fertilising them in the laboratory, and transferring the embryos into the uterus a few days later.
Croatian: Izvantjelesna oplodnja uključuje sakupljanje jajnih stanica iz jajnika, oplodnju tih stanica u laboratoriju te prijenos embrija u maternicu nakon nekoliko dana.
English: Components of the Elonva syringe with needle
Croatian: Dijelovi Elonva štrcaljke s iglom
English: Pharmacokinetic parameters of corifollitropin alfa were evaluated after subcutaneous administration in women undergoing a COS treatment cycle.
Croatian: Farmakokinetički parametri korifolitropina alfa bili su procijenjeni nakon supkutane primjene u žena podvrgnutih ciklusu liječenja kontroliranom stimulacijom jajnika.
English: Hepatic metabolism contributes to a minor extent to the elimination of corifollitropin alfa.
Croatian: Jetreni metabolizam u manjoj mjeri pridonosi eliminaciji korifolitropina alfa.
English: Pituitary suppression with a GnRH antagonist (ganirelix acetate injection at a daily dose of 0.25 mg) was used in each of the three clinical trials.
Croatian: Supresija hipofize pomoću antagonista GnRH (injekcija ganireliksacetata u dnevnoj dozi od 0,25 mg) primijenila se u svakom od ova tri klinička ispitivanja.
English: There are limited data on the use of Elonva in combination with a GnRH agonist.
Croatian: Postoje ograničeni podaci o primjeni lijeka Elonva u kombinaciji s agonistom GnRH.
English: In these women the benefits of gonadotropin administration need to be weighed against the risks.
Croatian: U tih žena treba procijeniti korist u odnosu na rizike primjene gonadotropina.
English: The mean number of embryos transferred in the FTET cycles of ENGAGE was 1.7 in both treatment groups.
Croatian: Srednja vrijednost broja embrija transferiranih u FTET ciklusima u ispitivanju ENGAGE iznosila je 1,7 u obje liječene skupine.
English: Follow current clinical practice for reducing the risk of OHSS during Assisted Reproductive Technology (ART).
Croatian: Potrebno je slijediti trenutačnu kliničku praksu za smanjenje rizika OHSS-a tijekom postupka potpomognute oplodnje (engl.
English: It is not known if treatment with fertility medicines increases the risk of these tumours in infertile women.
Croatian: Nije poznato povećava li liječenje lijekovima za plodnost rizik od tih tumora u neplodnih žena.
English: The incidence of congenital malformations after ART may be slightly higher than after spontaneous conceptions.
Croatian: Incidencija kongenitalnih malformacija nakon postupka potpomognute oplodnje može biti nešto veća nego nakon spontanog začeća.
English: The first symptoms of ovarian overstimulation may be noticed as pain in the stomach (abdomen), feeling sick or diarrhoea.
Croatian: Prvi simptomi pretjerane stimulacije jajnika mogu se opaziti kao bol u trbuhu (abdomenu), mučnina ili proljev.
English: *Live birth rate was a secondary efficacy endpoint in ENGAGE and PURSUE.
Croatian: *Stopa živorođenih bila je sekundarni ishod djelotvornosti u ispitivanjima ENGAGE i PURSUE.
English: 1) postdose.
Croatian: 1) nakon primjene.
English: For women having their first cycle of ovarian stimulation, for whom risk factors are only partially known, close observation for early signs and symptoms of OHSS is recommended.
Croatian: Preporučuje se pažljivo nadzirati žene koje imaju prvi ciklus stimulacije jajnika i za koje su tek djelomično poznati faktori rizika zbog ranih znakova i simptoma OHSS-a.