FrancophonIA/ELRC3.0 huggingface dataset:
English: The AMH concentration is to be expressed in pmol/L and is to be rounded off to the nearest integer.
Croatian: Koncentraciju AMH je potrebno izraziti u pmol/L i zaokružiti na najbliži cijeli broj.
English: Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.
Croatian: Oštećenje jajnika uslijed smanjene opskrbe krvlju može se umanjiti ranom dijagnozom i hitnom detorzijom.
English: For example, if the number in column C is 5.34, round your remaining dose to 5.33.
Croatian: Na primjer, ukoliko je broj u stupcu C 5,34, zaokružite Vašu preostalu dozu na 5,33.
English: The fraction of follitropin delta excreted unchanged in the urine was estimated to 9%.
Croatian: Procijenjeno je da frakcija folitropina delta koja se izlučuje nepromijenjena u urinu iznosi 9%.
English: • Keep pressing the injection button in and when you see the number ‘0' lined up with the dose indicator, wait for 5 seconds (slowly count to 5).
Croatian: • Držite pritisnuto dugme za ubrizgavanje i kad vidite da se broj “0” poravnao s pokazivačem doze pričekajte 5 sekundi (polako brojite do 5).
English: If the patient had adequate ovarian response in the previous cycle without developing OHSS, the same daily dose should be used.
Croatian: Ako je bolesnica imala odgovarajući odgovor jajnika u prethodnom ciklusu bez da se razvio OHSS, potrebno je primijeniti istu dnevnu dozu.
English: REKOVELLE pre-filled pens: • Throw away (dispose of) your used pens in accordance with local waste regulations.
Croatian: REKOVELLE napunjena brizgalica: • Bacite (odložite) Vaše iskorištene brizgalice u skladu s lokalnim propisima o odlaganju otpada.
English: Please contact your doctor as soon as you notice that you forgot a dose.
Croatian: Vašeg liječnika čim primijetite da ste zaboravili primijeniti dozu.
English: • Throw away (dispose of) the used needle carefully (D).
Croatian: • Pažljivo bacite (zbrinite) iskorištenu iglu (D).
English: If you use more REKOVELLE than you should
Croatian: Ako primijenite više lijeka REKOVELLE nego što ste trebali
English: • You have slowly counted to 5 while you are still holding the injection button in and the needle is still in your skin.
Croatian: • Polako ste brojili do 5 dok ste i dalje držali pritisnutim dugme za injiciranje doze i igla je još u Vašoj koži.
English: • Doses should be rounded off to nearest increment, X.00, X.33 or X.66 micrograms.
Croatian: • Doze se moraju zaokružiti na najbliži korak: X,00, X,33 ili X,66 mikrograma.
English: Do not use REKOVELLE if:
Croatian: Nemojte primjenjivati REKOVELLE:
English: Your healthcare provider should show you how to prepare and inject REKOVELLE the right way before you inject it for the first time.
Croatian: Zdravstveni djelatnik mora Vam pokazati kako pripremiti i ubrizgati REKOVELLE na ispravan način prije nego si ubrizgavate lijek prvi put.
English: The relevance of these findings for the clinical use of REKOVELLE is limited.
Croatian: Značaj ovih nalaza za kliničku primjenu lijeka REKOVELLE je ograničen.
English: • Use a new injection site for each injection to lower the risk of skin reactions as redness and irritation.
Croatian: • Koristite novo mjesto injiciranja kod svake primjene kako biste smanjili rizik kožnih reakcija kao što su crvenilo i nadraženost.
English: Gonadotropin therapy requires time commitment by physicians and supportive healthcare professionals, as well as the availability of appropriate monitoring facilities.
Croatian: Terapija gonadotropinima zahtijeva mnogo vremena liječnika i pratećeg zdravstvenog osoblja, kao i dostupnost prikladnih uvjeta za kontrolu.
English: It should be noted however that pregnancy itself as well as OHSS also carry an increased risk of thromboembolic events.
Croatian: Potrebno je napomenuti da i sama trudnoća, kao i OHSS, donosi povećan rizik od tromboembolije.
English: Before starting treatment with this medicine, a doctor should check you and your partner for possible causes of your fertility problems.
Croatian: Prije nego započnete liječenje ovim lijekom, potrebno je da Vas i Vašeg partnera liječnik pregleda zbog mogućeg uzroka problema s plodnošću.
English: Conversely, increasing body weight leads to a decrease in the number of oocytes retrieved (only clinically relevant for REKOVELLE doses below 12 micrograms).
Croatian: Suprotno tome, s povećanjem tjelesne težine opada broj dobivenih oocita (klinički značajno samo za doze lijeka REKOVELLE niže od 12 mikrograma).
English: Single blastocyst transfer on day 5 was compulsory with the exception of patients 38-40 years in whom double blastocyst transfer was performed if no good-quality blastocysts were available.
Croatian: Prijenos jedne blastociste 5. dana je bio obavezan osim kod bolesnica u dobi od 38-40 godina u kojih je izveden prijenos dvije blastociste ako nije bilo blastocista dobre kakvoće.
English: The dose should be based on a recent determination of AMH (i.e. within the last 12 months) measured by the following diagnostic test from Roche: ELECSYS AMH Plus immunoassay (see section 4.4).
Croatian: Dozu je potrebno temeljiti na nedavnom određivanju razine AMH (odnosno unutar posljednjih 12 mjeseci) pomoću sljedećeg dijagnostičkog testa proizvođača Roche: ELECSYS AMH Plus imunotest (vidjeti dio 4.4).
English: Ongoing pregnancy rate 30.7% Ongoing implantation rate 35.2% Population: all randomised and exposed
Croatian: Stopa implantacije u tijeku 35,2% Populacija: svi randomizirani i izloženi
English: In all patients with anti-FSH antibodies, titres were undetectable or very low and without neutralising capacity.
Croatian: U svih bolesnica s anti-FSH antitijelima, titar je bio nedetektibilan ili vrlo nizak i bez neutralizacijskog kapaciteta.
English: For the next treatment cycle, your doctor will in this case give you either a higher or a lower daily dose of REKOVELLE than before.
Croatian: Za sljedeći će Vam ciklus liječenja Vaš liječnik u tom slučaju dati ili višu ili nižu dnevnu dozu lijela REKOVELLE od prethodne.
English: • The injection button is firmly pushed in all the way until it stops.
Croatian: • Dugme za injiciranje je čvrsto pritisnuto do kraja, sve dok se ne zaustavi.
English: The frequency of these adverse reactions might decrease with repeated treatment cycles, as this has been observed in clinical trials.
Croatian: Učestalost ovih nuspojava može se smanjiti s ponavljanjem ciklusa liječenja kao što je to primijećeno tijekom kliničkih ispitivanja.
English: Before starting to use this medicine, tell your doctor if:
Croatian: Prije početka primjene ovog lijeka, obavijestite svog liječnika ako:
English: • Do not inject into an area that is sore (tender), bruised, red, hard, scarred or where you have stretch marks.
Croatian: • Nemojte injicirati u područje koje je bolno (osjetljivo), s modricama, crveno, tvrdo ili gdje postoje ožiljci ili strije.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 December 2016
Croatian: Datum prvog odobrenja: 12. prosinca 2016
English: Follitropin delta is a recombinant human FSH.
Croatian: Folitropin delta je rekombinantni humani FSH.
English: • If needed, the outside of your pen may be cleaned with a cloth moistened with water.
Croatian: • Ukoliko je potrebno, vanjski dio brizgalice možete očistiti pomoću krpice navlažene vodom.
English: Do not use the pen if it is damaged.
Croatian: Nemojte je upotrijebiti ukoliko je oštećena.
English: Throw away (dispose of) the pen if it has not been used after 3 months.
Croatian: Bacite (zbrinite) brizgalicu nakon isteka 3 mjeseca ukoliko je niste koristili.
English: • Do not put the pen in water or any other liquid.
Croatian: • Nemojte uranjati Vašu brizgalicu u vodu ili bilo koju drugu tekućinu.
English: Do not use this medicine if you are pregnant or breast-feeding.
Croatian: Ne primjenjujte ovaj lijek ako ste trudni ili dojite.
English: Studies in animals have shown reproductive toxicity with REKOVELLE doses above the recommended maximal dose in humans (section 5.3).
Croatian: Ispitivanja na životinjama su pokazala reproduktivnu toksičnost kod primjene lijeka REKOVELLE u dozama višim od maksimalnih preporučenih doza za ljude (vidjeti dio 5.3).
English: In distinction to uncomplicated ovarian enlargement, OHSS is a condition that can manifest itself with increasing degrees of severity.
Croatian: Za razliku od nekompliciranog povećanja jajnika, OHSS je stanje koje se može manifestirati povećavajućim stupnjevima težine.
English: Other medicines and REKOVELLE
Croatian: Drugi lijekovi i REKOVELLE
English: Because of the risk of developing OHSS patients should be followed for at least two weeks after triggering of final follicular maturation.
Croatian: Zbog rizika od razvoja OHSS-a, bolesnice je potrebno pratiti tijekom najmanje dva tjedna nakon indukcije konačnog sazrijevanja folikula.
English: • Do not use a pen if it has been dropped or hit against hard surfaces.
Croatian: • Nemojte upotrijebiti brizgalicu ako Vam je ispala ili je udarila u tvrdu površinu.
English: Ovarian hyperstimulation syndrome may possibly occur, which is described in section 4.
Croatian: Može doći do sindroma hiperstimulacije jajnika, što je opisano u dijelu 4.
English: • Make sure you have the correct pen with correct strength.
Croatian: • Provjerite imate li odgovarajuću brizgalicu s odgovarajućom jačinom.
English: Follitropin delta is expected to be eliminated similarly to other follitropins, i.e. mainly by the kidneys.
Croatian: Za folitropin delta se očekuje da se eliminira slično drugim folitropinima, odnosno, uglavnom preko bubrega.
English: If you have any of these symptoms you should contact a doctor immediately.
Croatian: Ako imate bilo koji od ovih simptoma, odmah kontaktirajte Vašeg liječnika.
English: • malformations of sexual organs incompatible with pregnancy
Croatian: • malformacije spolnih organa koje nisu kompatibilne s trudnoćom
English: It is important to stress the value of careful and frequent monitoring of follicular development in order to reduce the risk of OHSS.
Croatian: Važno je istaknuti važnost pažljivog i redovitog praćenja razvoja folikula u svrhu smanjenja rizika od OHSS-a.
English: • Pinch your skin and insert the needle straight into your skin as shown by your healthcare provider.
Croatian: • Uhvatite kožni nabor i uvedite iglu ravno u kožu na način kako Vam je pokazao Vaš zdravstveni djelatnik.
English: Priming - (Step 7 to 9)
Croatian: Priprema - (Korak 7 do 9)
English: The most important effect resulting from parenteral administration of FSH is the development of multiple mature follicles.
Croatian: Najvažniji učinak parenteralne primjene FSH je razvoj više zrelih folikula.
English: Call your healthcare provider (doctor, nurse or pharmacist) if you have any questions about how to give your REKOVELLE injection.
Croatian: Nazovite Vašeg zdravstvenog djelatnika (liječnika, medicinsku sestru ili ljekarnika) ukoliko imate bilo kakvih pitanja o tome kako primijeniti injekciju lijeka REKOVELLE.
English: • Column B shows an example of the dose that is left in the pen (this is equal to what you are able to dial).
Croatian: • Stupac B prikazuje primjer doze koja je preostala u brizgalici (to je jednako onom što možete odabrati).
English: Gonadotropins like this medicine may cause ovarian hyperstimulation syndrome.
Croatian: Gonadotropini poput ovog lijeka mogu uzrokovati sindrom hiperstimulacije jajnika.
English: • Do not press the injection button when dialing the dose to avoid loss of medicine.
Croatian: • Nemojte pritiskati dugme za ubrizgavanje za vrijeme odabira doze kako biste izbjegli gubitak lijeka.
English: The maximum daily dose for the first treatment cycle is 12 micrograms.
Croatian: Maksimalna dnevna doza u prvom ciklusu liječenja je 12 mikrograma.
English: In these women, the benefits of gonadotropin administration need to be weighed against the risks.
Croatian: U tih je žena potrebno procijeniti korist od primjene gonadotropina u odnosu na rizik.
English: • Check the pen to see that it is not damaged.
Croatian: • Provjerite brizgalicu da nije oštećena.
English: If you decide to give a split-dose injection, follow these instructions and write down how much medicine to give using the split-dose diary on Page 231.
Croatian: Ukoliko se odlučite za primjenu podijeljene doze, slijedite ove upute i zapišite koliko ćete lijeka primijeniti u dnevnik podijeljenih doza na stanici 231.
English: After first use: Use within 28 days.
Croatian: Nakon prve primjene: Upotrijebiti unutar 28 dana.
English: Infertility treatment can increase the risk of this happening, especially if you are overweight or you or someone in your family (blood relative) have a known blood clotting disease (thrombophilia).
Croatian: Liječenje neplodnosti može povećati rizik od ovog događaja, posebno ako ste pretili ili ako Vi ili netko iz Vaše obitelji (krvni srodnik) imate poznati poremećaj zgrušavanja krvi (trombofilija).
English: REKOVELLE stimulates the ovaries to grow and develop many egg sacs (‘follicles'), from which eggs are collected and fertilised in the laboratory.
Croatian: REKOVELLE potiče jajnike na rast i razvoj mnogo jajnih vrećica ('folikula'), iz kojih se jajne stanice skupljaju i oplođuju u laboratoriju.
English: The incidence of anti-FSH antibodies after treatment with REKOVELLE was 1.1% in cycle 1, 0.8% in cycle 2 and 1.1% in cycle 3.
Croatian: Incidencija anti-FSH antitijela nakon liječenja lijekom REKOVELLE bila je 1,1% u 1. ciklusu, 0,8% u 2. ciklusu i 1,1% u 3. ciklusu.
English: The overdose of follitropin delta resulted in pharmacological or exaggerated pharmacological actions.
Croatian: Predoziranje folitropinom delta uzrokovalo je farmakološku ili pretjeranu farmakološku aktivnost.
English: Step 11 and 12:
Croatian: Korak 11 i 12:
English: Examples of prescribed dose (in micrograms)
Croatian: Primjeri propisane doze (u mikrogramima)
English: Follitropin delta leads to greater exposure than follitropin alfa.
Croatian: Folitropin delta dovodi do veće izloženosti nego folitropin alfa.
English: • If blood appears at the injection site, press a gauze pad or cotton ball lightly to the injection site.
Croatian: • Ukoliko se pojavi krv na mjestu injiciranja, lagano pritisnite jastučić gaze ili pamučni jastučić na mjesto injiciranja.
English: The terminal elimination half-life after single subcutaneous administration is 40 hours and after multiple subcutaneous administration is 28 hours.
Croatian: Terminalno poluvrijeme eliminacije nakon jednokratne supkutane primjene je 40 sati, a nakon višekratne supkutane primjene je 28 sati.
English: Following repeated daily subcutaneous administrations, REKOVELLE reaches steady-state within 6 to 7 days with a threefold higher concentration compared with the concentration after the first dose.
Croatian: Kod ponovljene svakodnevne supkutane primjene, REKOVELLE postiže stanje dinamičke ravnoteže unutar 6 do 7 dana s trostruko višom koncentracijom u odnosu na koncentraciju nakon prve doze.
English: • After the needle is inserted, place your thumb on the injection button.
Croatian: • Nakon što ste uveli iglu, smjestite Vaš palac na dugme za ubrizgavanje.
English: The prevalence of ectopic pregnancy after ART has been reported to be higher than in the general population.
Croatian: Prijavljeno je da je prevalencija ektopične trudnoće nakon MPO-a viša nego u općoj populaciji.
English: • If the injection button is not easy to push in, do not use force.
Croatian: • Ukoliko dugme za injiciranje ne možete lagano pritisnuti, nemojte upotrebljavati silu.
English: REKOVELLE pre-filled pen and its parts
Croatian: REKOVELLE napunjena brizgalica i njeni dijelovi
English: • You may need more than one pen to complete your prescribed dose.
Croatian: • Možda će Vam trebati više od jedne brizgalice za potpunu primjenu propisane doze.
English: It is more commonly seen in patients with polycystic ovarian syndrome and usually regresses without treatment.
Croatian: Češće je primijećen u bolesnica sa sindromom policističnih jajnika i obično se povlači bez liječenja.
English: If the injection button still is not easy to push in after changing the needle, use a new pen.
Croatian: Ukoliko se dugme za injiciranje i nakon promjene igle ne može lagano pritisnuti, upotrijebite novu brizgalicu.
English: • Store the pen out of the reach of children and anyone who has not been trained to use the pen.
Croatian: • Čuvajte brizgalicu izvan dohvata djece ili bilo koga tko nije obučen za primjenu brizgalice.
English: Because follitropin delta is produced in the human cell line PER.C6, the glycosylation profile is different from follitropin alfa and follitropin beta.
Croatian: Obzirom da je folitropin delta proizveden na ljudskoj staničnoj liniji PER.C6, glikozilacijski profil drugačiji je nego kod folitropina alfa i folitropina beta.
English: • If you are blind or have poor eyesight and cannot read the dose scale on the pen, do not use this pen without help.
Croatian: • Ukoliko ste slijepa ili slabovidna osoba i ne možete očitati ljestvicu doza na brizgalici, nemojte upotrebljavati brizgalicu bez pomoći.
English: Women with recent or ongoing thromboembolic disease or women with generally recognised risk factors for thromboembolic events, such as personal or family history, severe obesity (body mass index >30 kg/m2) or thrombophilia may have an increased risk of venous or arterial thromboembolic events, during or following treatment with gonadotropins.
Croatian: Žene koje su nedavno imale ili imaju tromboembolijsku bolest ili žene koje imaju opće poznate faktore rizika za tromboemboliju, kao što su osobna ili obiteljska anamneza, teška pretilost (indeks tjelesne mase >30 kg/m2) ili trombofilija, mogu imati povećan rizik od venske ili arterijske tromboembolije tijekom ili nakon liječenja gonadotropinima.
English: • you suffer from bleeding from the vagina without any known cause
Croatian: • ako imate krvarenje iz rodnice nepoznatog uzroka
English: This medicine does not affect your ability to drive and use machines.
Croatian: Ovaj lijek ne utječe na Vašu sposobnost vožnje i upravljanja strojevima.
English: Therefore, in cases of ovarian hyperstimulation it is prudent to withhold hCG and advise the patient to refrain from coitus or to use barrier contraceptive methods for at least 4 days.
Croatian: Zbog toga, u slučaju hiperstimulacije jajnika, savjetuje se ne primijeniti hCG i savjetovati bolesnicu da se suzdrži od spolnih odnosa ili koristi mehaničke metode kontracepcije tijekom najmanje 4 dana.
English: 20 (Dial to 20)
Croatian: 20 (Okrenite do 20)
English: • Prepare and prime a new pen (Step 1 to 9).
Croatian: • Pripremite novu brizgalicu (Korak 1 do 9).
English: Step 3: • Pull off the protective foil from the needle.
Croatian: Korak 3: • Skinite zaštitnu foliju s igle.
English: • Check the pen (cartridge) to see that the medicine is clear and does not contain particles.
Croatian: • Provjerite brizgalicu (uložak) da biste vidjeli je li lijek bistar i da ne sadrži vidljive čestice.
English: As the rat bioassay might not fully reflect the potency of the FSH in REKOVELLE in humans, REKOVELLE is dosed in micrograms and not in IU.
Croatian: Kako bioispitivanje u štakora ne mora u potpunosti prikazivati potentnost FSH iz lijeka REKOVELLE u ljudi, REKOVELLE se dozira u mikrogramima, a ne u IU.
English: For the first treatment cycle, the individual daily dose will be determined on the basis of the woman's serum anti-Müllerian hormone (AMH) concentration and her body weight.
Croatian: U prvom ciklusu liječenja, individualna dnevna doza bit će određena temeljem koncentracije serumskog anti-Müllerovog hormona (AMH) u žene i njezine tjelesne težine.
English: Before use - (Step 1)
Croatian: Prije uporabe - (Korak 1) Korak 1:
English: Clots in the blood vessels (veins or arteries) are more likely in women who are pregnant.
Croatian: Pojava ugrušaka u krvnim žilama (venama ili arterijama) je vjerojatnija u trudnih žena.
English: The two co-primary endpoints were ongoing pregnancy rate and ongoing implantation rate in the fresh cycle, defined as at least one intrauterine viable fetus 10-11 weeks after transfer and number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of blastocysts transferred, respectively.
Croatian: Dvije ko-primarne mjere ishoda su bile stopa trudnoće u tijeku i stopa implantacije u tijeku u novom ciklusu, definirane kao najmanje jedan intrauterini vijabilan fetus 10-11 tjedana nakon prijenosa, odnosno, broj intrauterinih vijabilnih fetusa 10-11 tjedana nakon prijenosa podijeljeno s brojem prenesenih blastocista.
English: • The dose scale of the pen is numbered from 0 to 20 micrograms.
Croatian: • Dozna ljestvica brizgalice je označena brojevima od 0 do 20 mikrograma.
English: The patients should be advised of the potential risk of multiple births before starting treatment.
Croatian: Bolesnice je potrebno savjetovati o mogućem riziku od višeplodne trudnoće prije početka liječenja.
English: • After pressing in the injection button for 5 seconds, release the injection button.
Croatian: • Nakon što ste držali pritisnutim dugme za injiciranje kroz 5 sekundi, pustite dugme za injiciranje.
English: • When turning the dial to your dose, you will hear a click sound and feel resistance on the dial for each increment to help you dial the correct dose.
Croatian: • Kad okrećete izbornik za podešavanje doze, čuti ćete zvuk “klik” i osjetiti otpor na izborniku za svako povećanje kako bi Vam se olakšalo biranje ispravne doze.
English: Adherence to the REKOVELLE dose and regimen of administration and careful monitoring of therapy will minimise the incidence of such events.
Croatian: Pridržavanje dozi lijeka REKOVELLE i režimu primjene te pažljivo praćenje liječenja, svest će na minimum incidenciju takvih događaja.
English: L-methionine
Croatian: L-metionin
English: • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
Croatian: • se može zatvoriti s poklopcem koji čvrsto prijanja i neprobojan je, bez mogućnosti da oštri predmet izađe,
English: In particular, patients should be evaluated for hypothyroidism and hyperprolactinemia, and the appropriate specific treatment should be given.
Croatian: Posebice je u bolesnica potrebno provjeriti mogućnost hipotireoze i hiperprolaktemije te odrediti odgovarajuće specifično liječenje.
English: Safe and effective use of REKOVELLE calls for monitoring of ovarian response with ultrasound alone, or in combination with measurement of serum estradiol levels, on a regular basis.
Croatian: Sigurna i učinkovita primjena lijeka REKOVELLE zahtijeva redovito praćenje odgovora jajnika pomoću samo ultrazvuka ili u kombinaciji s mjerenjem serumskih razina estradiola.
English: Circulating levels of follitropin delta are inversely related to the body weight, which supports individualised dosing based on body weight.
Croatian: Cirkulirajuće razine folitropina delta obrnuto su proporcionalne tjelesnoj težini, što podupire individualizirano doziranje na temelju tjelesne težine.
English: OHSS is an intrinsic risk of the ovarian stimulation.
Croatian: OHSS je intrinzičan rizik kod stimulacije jajnika.
English: Treatment with REKOVELLE should be initiated day 2 or 3 after start of menstrual bleeding, and continue until adequate follicular development (≥3 follicles ≥17 mm) has been achieved, which on average is by the ninth day of treatment (range 5 to 20 days).
Croatian: Liječenje lijekom REKOVELLE treba započeti 2. ili 3. dan nakon početka menstrualnog krvarenja i nastaviti dok se ne dosegne odgovarajući razvoj folikula (≥3 folikula ≥17 mm), što je u prosjeku do devetog dana liječenja (raspon od 5. do 20. dana).
English: If the AMH concentration is in ng/mL, the concentration should be converted to pmol/L by multiplying with 7.14 (ng/mL x 7.14 = pmol/L) before use.
Croatian: Ako je koncentracija AMH u ng/mL, koncentraciju je potrebno izraziti u pmol/L množenjem sa 7,14 (ng/mL x 7.14 = pmol/L) prije primjene. μg: mikrogrami