FrancophonIA/ELRC3.0 huggingface dataset:
English: You might have a higher risk of these problems occurring or becoming worse with Ovaleap treatment.
Croatian: Možete imati povišen rizik od nastanka ovih tegoba ili njihovog pogoršanja uz liječenje Ovaleapom.
English: • The usual dose of this medicine is 150 IU together with hCG.
Croatian: • Uobičajena doza ovog lijeka je 150 IU zajedno s hCG.
English: Follitropin alfa should not be used when an effective response cannot be obtained.
Croatian: Folitropin alfa ne smije se primjenjivati kad se ne može dobiti učinkoviti odgovor.
English: If you are not ovulating, have no periods and have been diagnosed with very low levels of FSH and LH hormones
Croatian: Ako nemate ovulaciju, nemate menstruaciju i dijagnosticirane su Vam vrlo niske razine hormona FSH i LH
English: If severe OHSS occurs, it is recommended that gonadotropin treatment be stopped if still ongoing and that the patient be hospitalised and appropriate therapy be started.
Croatian: Ako nastane teški OHSS, preporučuje se prekinuti liječenje gonadotropinom ako se ono i dalje provodi i hospitalizirati pacijenticu te započeti s odgovarajućom terapijom.
English: When using this medicine, you have a higher risk of being pregnant with more than one child (i.e. “multiple pregnancy”, typically twins) than if you conceived naturally.
Croatian: Tijekom primjene ovog lijeka imate viši rizik od trudnoće s više od jednog djeteta (tj. „višeplodne trudnoće“, tipično blizanci) nego da ste začeli prirodno.
English: Complication of severe OHSS
Croatian: rijetko komplikacije teškog OHSS
English: • you feel sick or are vomiting,
Croatian: • imate mučninu ili povraćate,
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital systems, gonadotropins, ATC code: G03GA05.
Croatian: Farmakoterapijska skupina: spolni hormoni i modulatori genitalnog sustava, gonadotropini, ATK oznaka: G03GA05.
English: You can reduce the risk of multiple pregnancy by using the right dose of this medicine at the right times.
Croatian: Taj rizik od višeplodnih trudnoća možete smanjiti primjenom odgovarajuće doze ovog lijeka u odgovarajuće vrijeme.
English: The instructions for use of the pen must be followed carefully.
Croatian: Upute za uporabu brizgalice moraju se pažljivo slijediti.
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 sve većim stupnjem težine.
English: In menstruating women treatment should commence within the first 7 days of the menstrual cycle.
Croatian: U žena s menstruacijom liječenje treba započeti unutar prvih 7 dana menstrualnog ciklusa.
English: If after this period, the patient has not responded, the combination treatment may be continued; current clinical experience indicates that treatment for at least 18 months may be necessary to achieve spermatogenesis.
Croatian: Ako nakon tog razdoblja kod pacijenta nema odgovora, može se nastaviti s kombiniranim liječenjem; suvremeno kliničko iskustvo pokazuje da može biti potrebno najmanje 18 mjeseci liječenja da bi se postigla spermatogeneza.
English: • When you get the desired response, you will be given hCG or “recombinant hCG” (r-hCG, an hCG made in a laboratory by a special DNA technique).
Croatian: • Kad dobijete željeni odgovor, dat će Vam se hCG ili „rekombinantni hCG“ (r-hCG, to je hCG napravljen u laboratoriju pomoću posebne DNK tehnike).
English: If you experience the above symptoms your doctor might ask you to stop using this medicine (see also section 4 under “Serious side effects in women").
Croatian: Ako dobijete gore opisane simptome, liječnik Vas može zamoliti da prestanete primjenjivati ovaj lijek (pogledajte također dio 4 pod „Ozbiljne nuspojave u žena“).
English: Mild or moderate OHSS usually resolves spontaneously.
Croatian: Blagi ili umjereni OHSS obično spontano nestaje.
English: For accurate interpretation of the indices of follicle development and maturation, the physician should be experienced in the interpretation of the relevant tests.
Croatian: Da bi točno protumačio znakove razvoja i sazrijevanja folikula, liječnik treba imati iskustva u tumačenju relevantnih pretraga.
English: This is when your follicles develop too much and become large cysts.
Croatian: To je stanje kod kojeg se folikuli previše razviju i pretvore u velike ciste.
English: 4.7 Effects on ability to drive and use machines Ovaleap has no or negligible influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Ovaleap ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: May be stored before opening not above 25 °C for up to 3 months.
Croatian: Može se čuvati prije otvaranja na temperaturi ne iznad 25 °C do najviše 3 mjeseca.
English: Follitropin alfa should be given at a dose of 150 IU three times a week, concomitantly with hCG, for a minimum of 4 months.
Croatian: Folitropin alfa treba davati u dozi od 150 IU tri puta tjedno, istovremeno s hCG, tijekom najmanje 4 mjeseca.
English: Therefore, it is considered appropriate to give a lower total dose of follitropin alfa than generally used for urinary FSH, not only in order to optimise follicular development but also to minimise the risk of unwanted ovarian hyperstimulation (see section 5.1).
Croatian: Stoga se smatra prikladnim dati nižu ukupnu dozu folitropina alfa od one u kojoj se općenito primjenjuje urinarni FSH, ne samo radi optimiziranja razvoja folikula, nego i radi umanjivanja rizika od neželjene hiperstimulacije jajnika (vidjeti dio 5.1).
English: If you experience the above symptoms your doctor may recommend that you stop treatment.
Croatian: Ako dobijete gore opisane simptome, liječnik Vam može preporučiti da prestanete s liječenjem.
English: It is more commonly seen in women with polycystic ovarian syndrome and usually regresses without treatment.
Croatian: Češće se opaža u žena sa sindromom policističnih jajnika i obično nestaje bez liječenja.
English: Gonadotropin therapy requires a certain time commitment by physicians and supportive health professionals, as well as the availability of appropriate monitoring facilities.
Croatian: Terapija gonadotropinom iziskuje određenu vremensku posvećenost liječnika i pomoćnog zdravstvenog osoblja, kao i dostupnost odgovarajućih načina praćenja.
English: The adverse reactions are ranked under heading of frequency using the following convention: 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 the available data).
Croatian: Nuspojave su prikazane prema učestalosti sukladno sljedećoj konvenciji: 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
English: Tell your doctor straight away if:
Croatian: Odmah obavijestite svog liječnika:
English: There may be a degree of interpatient variability in response to FSH administration, with a poor response to FSH in some patients and exaggerated response in others.
Croatian: Može postojati određeni stupanj varijabilnosti odgovora na primjenu FSH između pacijenata, pri čemu odgovor na FSH u nekih pacijenata može biti slab, a u drugih prejak.
English: • If you have irregular periods, start using this medicine within the first 7 days of your menstrual cycle.
Croatian: • Ako imate neredovite menstruacije, počnite uzimati ovaj lijek unutar prvih 7 dana menstrualnog ciklusa.
English: Your doctor may suggest that you learn how to inject yourself with this medicine.
Croatian: Liječnik Vam može predložiti da naučite kako da sami sebi date ovaj lijek.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity and genotoxicity additional to that already stated in other sections of this SmPC.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti i genotoksičnosti jednokratne i ponovljenih doza uz onu već opisanu u drugim dijelovima ovog Sažetka opisa svojstava lijeka.
English: • you have stomach, arm or leg pain.
Croatian: • ako imate bol u trbuhu, ruci ili nozi.
English: Nevertheless one could expect Ovarian Hyper-Stimulation Syndrome (OHSS) to occur, which is described in section 4 under “Serious side effects in women".
Croatian: Ipak, može se očekivati nastanak sindroma hiperstimulacije jajnika (OHSS), koji je opisan u dijelu 4 pod „Ozbiljne nuspojave u žena“.
English: It is not yet established whether or not treatment with gonadotropins increases the risk of these tumours in infertile women.
Croatian: Još nije ustanovljeno povećava li liječenje gonadotropinima rizik od takvih tumora u neplodnih žena.
English: For instructions on the administration with the Ovaleap Pen, see section 6.6.
Croatian: Za upute o primjeni s brizgalicom Ovaleap Pen, vidjeti dio 6.6.
English: Excipient(s) with known effect:
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom
English: If you do not have periods, you can start using the medicine on any convenient day.
Croatian: Ako nemate menstruaciju, možete početi uzimati ovaj lijek bilo kojeg dana kad Vam je to prikladno.
English: Elevated endogenous FSH levels are indicative of primary testicular failure.
Croatian: Povišene razine endogenog FSH indikativne su za primarno zatajenje testisa.
English: If a patient fails to respond adequately after 4 weeks of treatment, that cycle should be abandoned and the patient should undergo further evaluation after which she may recommence treatment at a higher starting dose than in the abandoned cycle.
Croatian: Ako u pacijentice ne nastupi odgovarajući odgovor nakon 4 tjedna liječenja, taj je ciklus potrebno prekinuti, a pacijenticu dodatno pregledati nakon čega može započeti liječenje višim početnim dozama od onih u prekinutom ciklusu.
English: In women with recent or ongoing thromboembolic disease or women with generally recognised risk factors for thromboembolic events, such as personal or family history, treatment with gonadotropins may further increase the risk for aggravation or occurrence of such events.
Croatian: U žena s nedavnom ili postojećom tromboembolijskom bolešću ili u žena s općepoznatim čimbenicima rizika za tromboembolijske događaje, kao što su trombo-embolijski događaji u osobnoj ili obiteljskoj anamnezi, liječenje gonadotropinima može dodatno povećati rizik od pogoršanja ili nastanka takvih događaja.
English: The effects of an overdose of follitropin alfa are unknown, nevertheless, there is a possibility that OHSS may occur (see section 4.4).
Croatian: Učinci predoziranja folitropinom alfa nisu poznati, međutim, postoji mogućnost nastanka OHSS (vidjeti dio 4.4).
English: Patients with porphyria or a family history of porphyria should be closely monitored during treatment with follitropin alfa.
Croatian: Pacijente s porfirijom ili obiteljskom anamnezom porfirije treba pažljivo pratiti tijekom liječenja folitropinom alfa.
English: • The maximum daily dose of this medicine is usually not higher than 225 IU.
Croatian: • Najviša dnevna doza ovog lijeka obično nije viša od 225 IU.
English: To minimise the risk of multiple pregnancy, careful monitoring of ovarian response is recommended.
Croatian: Da bi se smanjio rizik od višeplodne trudnoće, preporučuje se pažljivo pratiti odgovor jajnika.
English: Table 3: Results of study GF 8407 (randomised parallel group study comparing efficacy and safety of follitropin alfa with urinary FSH in ART)
Croatian: Tablica 3: Rezultati ispitivanja GF 8407 (randomizirano ispitivanje na usporednim skupinama u kojem su se uspoređivale djelotvornost i sigurnost folitropina alfa s urinarnim FSH kod MPO)
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine po učestalosti, nuspojave su navedene slijedom prema sve manjoj ozbiljnosti.
English: In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of follitropin alfa.
Croatian: U slučaju izloženosti tijekom trudnoće, nema dovoljno kliničkih podataka da bi se isključio teratogeni učinak folitropina alfa.
English: A commonly used regimen commences at 75-150 IU FSH daily and is increased preferably by 37.5 or 75 IU at 7 or preferably 14 day intervals if necessary, to obtain an adequate, but not excessive, response.
Croatian: Režim koji se uobičajeno primjenjuje započinje sa 75-150 IU FSH dnevno i povećava se po mogućnosti za 37,5 ili 75 IU u vremenskim razmacima od 7 ili još bolje 14 dana, po potrebi, da bi se postigao odgovarajući, ali ne prejaki odgovor.
English: Adherence to recommended follitropin alfa dose and regimen of administration can minimise the risk of ovarian hyperstimulation (see sections 4.2 and 4.8).
Croatian: Pridržavanje preporučene doze folitropina alfa i režima primjene može smanjiti rizik od hiperstimulacije jajnika (vidjeti dijelove 4.2 i 4.8).
English: Women
Croatian: Žene
English: Ovaleap is a biosimilar medicinal product.
Croatian: Ovaleap je biosličan lijek.
English: If you have ever had blood clots in your leg or lung, or a heart attack or stroke, or if your family have experienced these, inform your doctor.
Croatian: Tegobe zbog krvnih ugrušaka (tromboembolijski događaji) Ako ste ikad imali krvne ugruške u nogama ili plućima, srčani ili moždani udar ili ako se to dogodilo u Vašoj obitelji, obavijestite svog liječnika.
English: What Ovaleap is and what it is used for What you need to know before you use Ovaleap How to use Ovaleap
Croatian: Što je Ovaleap i za što se koristi Što morate znati prije nego počnete primjenjivati Ovaleap Kako primjenjivati Ovaleap
English: This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and multiple pregnancies.
Croatian: Smatra se da je to zbog razlika u osobinama roditelja (npr. dob majke, osobine sperme) i višeplodnih trudnoća.
English: The maximal daily dose is usually not higher than 225 IU FSH.
Croatian: Najveća dnevna doza obično nije viša od 225 IU FSH.
English: Luteal phase support may be considered since lack of substances with luteotropic activity (LH/hCG) after ovulation may lead to premature failure of the corpus luteum.
Croatian: Može se razmotriti podržavanje lutealne faze jer nedostatak tvari s luteotropnom aktivnosti (LH/hCG) nakon ovulacije može dovesti do preuranjenog propadanja žutog tijela.
English: 6.6 Special precautions for disposal and other handling No special requirements for disposal.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Nema posebnih zahtjeva za zbrinjavanje.
English: • you gain any weight rapidly,
Croatian: • brzo Vam se poveća tjelesna težina,
English: A certain degree of ovarian enlargement is an expected effect of controlled ovarian stimulation.
Croatian: Određeni stupanj povećanja jajnika očekivani je učinak kontrolirane stimulacije jajnika.
English: This could be related to multiple pregnancies or to parent characteristics such as maternal age and sperm characteristics.
Croatian: To može biti povezano s višeplodnim trudnoćama ili sa značajkama roditelja poput dobi majke i karakteristika sperme.
English: • if you are allergic to follitropin alfa, Follicle Stimulating Hormone (FSH) or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na folitropin alfa, folikulostimulirajući hormon (FSH) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: • Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients listed in section 6.1;
Croatian: • preosjetljivost na djelatnu tvar folitropin alfa, FSH ili neku od pomoćnih tvari navedenih u dijelu 6.1;
English: High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment as well as in pregnant women or while breast-feeding, because of the risk of accumulation and toxicity (metabolic acidosis).
Croatian: Veliki volumeni trebaju se primjenjivati s oprezom i samo ako je neophodno, osobito u osoba s oštećenjem funkcije jetre ili bubrega, kao i u trudnica ili dojilja, zbog rizika od akumulacije i toksičnosti (metabolička acidoza).
English: • The usual starting dose of this medicine is 150 to 225 IU each day, from day 2 or 3 of your menstrual cycle.
Croatian: • Uobičajena početna doza ovog lijeka je 150 do 225 IU svakog dana, od 2. ili 3. dana Vašeg menstrualnog ciklusa.
English: For example, following two weeks of treatment with an agonist, 150-225 IU follitropin alfa are administered for the first 7 days.
Croatian: Na primjer, nakon dva tjedna liječenja agonistom, primjenjuje se 150-225 IU folitropina alfa tijekom prvih 7 dana.
English: If your doctor cannot see a response after 5 weeks, that treatment cycle should be stopped.
Croatian: Ako Vaš liječnik ne vidi odgovor nakon 5 tjedana, taj ciklus liječenja treba prekinuti.
English: Following intravenous administration, follitropin alfa is distributed to the extracellular fluid space with an initial half-life of around 2 hours and eliminated from the body with a terminal half-life of about one day.
Croatian: Nakon intravenske primjene, folitropin alfa raspodjeljuje se u prostor izvanstanične tekućine, uz početni poluvijek od približno 2 sata, i uklanja se iz tijela uz krajnji poluvijek od približno jednog dana.
English: This medicine contains the active substance follitropin alfa, which is almost identical to a natural hormone produced by your body called “follicle-stimulating hormone” (FSH).
Croatian: Ovaj lijek sadrži djelatnu tvar folitropin alfa, koja je gotovo istovjetna prirodnom hormonu koji se stvara u Vašem tijelu a zove se „folikulostimulirajući hormon“ (FSH).
English: • The usual starting dose of this medicine is 75 to 150 IU each day.
Croatian: • Uobičajena početna doza ovog lijeka je 75 do 150 IU svakog dana.
English: The prevalence of congenital malformations after ART may be slightly higher than after spontaneous conceptions.
Croatian: Prevalencija kongenitalnih malformacija nakon MPO može biti neznatno viša nego nakon spontanog začeća.
English: This could cause chest pain, breathlessness, stroke or heart attack [see also section 2 under “Blood clotting problems (thromboembolic events)”].
Croatian: To može uzrokovati bol u prsnom košu, nedostatak zraka, moždani ili srčani udar [pogledajte također dio 2 pod „Tegobe zbog krvnih ugrušaka (tromboembolijski događaji)“].
English: Alternatively, intrauterine insemination may be performed by placing the sperm into the womb cavity.
Croatian: Alternativno, može se provesti intrauterina oplodnja stavljanjem sperme u šupljinu maternice.
English: The Ovaleap and GnRH agonist are then both given until your follicles develop as desired.
Croatian: Onda se Ovaleap i agonist GnRH daju sve dok se folikuli ne razviju do željenog stupnja.
English: What Ovaleap looks like and contents of the pack Ovaleap is a solution for injection (injection).
Croatian: Kako Ovaleap izgleda i sadržaj pakiranja Ovaleap je otopina za injekciju (injekcija).
English: The dose is then adjusted according to the ovarian response.
Croatian: Doza se potom prilagođava odgovoru jajnika.
English: Treatment is continued until adequate follicular development has been achieved (as assessed by monitoring of serum oestrogen concentrations and/or ultrasound examination), with the dose adjusted according to the patient's response, to usually not higher than 450 IU daily.
Croatian: S liječenjem se nastavlja sve dok se ne postigne odgovarajući razvoj folikula (što se procjenjuje praćenjem koncentracija estrogena u serumu i/ili ultrazvučnim pregledom), uz dozu prilagođenu sukladno odgovoru pacijentice, no obično ne višu od 450 IU na dan.
English: What Ovaleap contains - The active substance is follitropin alfa.
Croatian: Što Ovaleap sadrži - Djelatna tvar je folitropin alfa.
English: Thromboembolism may occur very rarely (see section 4.4).
Croatian: Tromboembolija može nastati vrlo rijetko (vidjeti dio 4.4).
English: In ART, aspiration of all follicles prior to ovulation may reduce the occurrence of hyperstimulation.
Croatian: Kod MPO, aspiracija svih folikula prije ovulacije može smanjiti pojavu hiperstimulacije.
English: The solution must not be used if it contains particles or if the solution is not clear.
Croatian: Otopina se ne smije primijeniti ako sadrži čestice ili nije bistra.
English: In women, FSH is needed for the growth and development of the sacs (follicles) in the ovaries that contain the egg cells.
Croatian: U žena je FSH potreban za rast i razvoj mjehurića (folikula) u jajnicima, koji sadrže jajne stanice.
English: • When your eggs are ready, you will be given hCG or r-hCG.
Croatian: • Kad jajašca budu spremna, dobit ćete hCG ili r-hCG.
English: Before opening and within its shelf life, you may remove this medicine from the refrigerator, without being refrigerated again, for up to 3 months.
Croatian: Prije otvaranja i unutar roka valjanosti, ovaj lijek možete izvaditi iz hladnjaka, a da ga ne vraćate ponovno u hladnjak, na najduže 3 mjeseca.
English: • primary ovarian failure;
Croatian: • primarnog zatajenja jajnika;
English: In men deficient in FSH, follitropin alfa administered concomitantly with hCG for at least 4 months induces spermatogenesis.
Croatian: U muškaraca s manjkom FSH, folitropin alfa primjenjivan istovremeno s hCG-om tijekom najmanje 4 mjeseca potiče spermatogenezu.
English: Such patients are unresponsive to follitropin alfa/hCG therapy.
Croatian: Ti pacijenti ne odgovaraju na terapiju folitropinom alfa/hCG-om.
English: In these women, the benefits of gonadotropin administration need to be weighed against the risks.
Croatian: U tih je žena potrebno procijeniti koristi naspram rizika primjene gonadotropina.
English: Treatment with follitropin alfa should be initiated under the supervision of a physician experienced in the treatment of fertility disorders.
Croatian: Liječenje folitropinom alfa treba započeti pod nadzorom liječnika s iskustvom u liječenju poremećaja plodnosti.
English: The Ovaleap Pen is a device (a “pen”) used for giving injections into the tissue just under the skin.
Croatian: Brizgalica Ovaleap Pen je naprava („brizgalica“) koja se koristi za davanje injekcija u tkivo neposredno ispod kože.
English: The dose recommendations given for follitropin alfa are those in use for urinary FSH.
Croatian: Preporučene doze dane za folitropin alfa su one koje se primjenjuju za urinarni FSH.
English: • Allergic reactions such as skin rash, raised itchy areas of skin and severe allergic reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the face have been reported very rarely (may affect up to 1 in 10,000 people).
Croatian: • alergijske reakcije kao što je kožni osip, odignuta područja na koži koja svrbe i teške alergijske reakcije sa slabošću, sniženjem krvnog tlaka, otežanim disanjem i otečenošću lica zabilježene su vrlo rijetko (mogu se javiti u manje od 1 na 10 000 osoba).
English: Adherence to recommended follitropin alfa dose and regimen of administration and careful monitoring of therapy will minimise the incidence of such events.
Croatian: Pridržavanje preporučene doze folitropina alfa i režima primjene te pažljivo praćenje terapije smanjit će incidenciju takvih pojava.
English: Clinical assessment of follitropin alfa indicates that its daily doses, regimens of administration and treatment monitoring procedures should not be different from those currently used for urinary FSH-containing medicinal products.
Croatian: Klinička procjena folitropina alfa pokazuje da dnevne doze, režimi primjene i postupci praćenja terapije ne bi smjeli biti različiti od onih koji se trenutno primjenjuju za lijekove koji sadrže urinarni FSH.