FrancophonIA/ELRC3.0 huggingface dataset:
English: Differences between the 2 groups were statistically significant (p< 0.05) for all criteria listed.
Croatian: Razlike između dvije grupe bile su statistički značajne (p<0,05) za sve navedene kriterije.
English: Do not remove the needle immediately, wait for 5 seconds, before pulling it out.
Croatian: Nemojte odmah izvući iglu; pričekajte 5 sekundi prije nego što je izvučete.
English: Take the pen out of the fridge 5 to 10 minutes before using it.
Croatian: Izvadite brizgalicu iz hladnjaka 5 do 10 minuta prije primjene.
English: In men, FSH is needed for the production of sperm.
Croatian: U muškaraca, FSH je potreban za proizvodnju sperme.
English: Deterioration or a first appearance of this condition may require cessation of treatment.
Croatian: Pogoršanje ili prva pojava te bolesti može zahtijevati prekid terapije.
English: It most often occurs after hormonal treatment has been discontinued and reaches its maximum at about seven to ten days following treatment.
Croatian: Najčešće se javlja nakon prekida hormonskog liječenja i doseže maksimum približno 7 - 10 dana nakon liječenja.
English: The medicinal product must be discarded if it has not been used after 3 months.
Croatian: Lijek se mora zbrinuti ako se ne iskoristi nakon 3 mjeseca.
English: The doses described below are stated in International Units (IU) and millilitres (mL).
Croatian: Doze navedene u nastavku izražene su u međunarodnim jedinicama (IU) i mililitrima (ml).
English: After the injection
Croatian: Nakon injekcije
English: If you forget to use Bemfola, do not take a double dose to make up for a forgotten dose.
Croatian: Ako zaboravite primijeniti lijek Bemfola, nemojte primijeniti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: It should be noted however that pregnancy itself as well as OHSS also carry an increased risk of thromboembolic events.
Croatian: No, treba imati na umu da trudnoća sama po sebi, baš kao i OHSS, također nosi povećan rizik od tromboembolijskih događaja.
English: • primary testicular insufficiency.
Croatian: • primarna insuficijencija testisa.
English: FSH is a gonadotropin, a type of hormone that plays an important role in human fertility and reproduction.
Croatian: FSH je gonadotropin, tip hormona koji ima važnu ulogu u ljudskoj plodnosti i reprodukciji.
English: Other medicines and Bemfola
Croatian: Drugi lijekovi i Bemfola
English: Please talk to your doctor as soon as you notice that you forgot a dose.
Croatian: Obratite se svom liječniku odmah kada primijetite da ste zaboravili primijeniti dozu.
English: • You will use these two medicines three times a week for at least 4 months.
Croatian: • Ta ćete dva lijeka primjenjivati tri puta tjedno najmanje 4 mjeseca.
English: • Swelling of the veins above and behind the testicles (varicocele).
Croatian: • oticanje vena iznad i iza testisa (varikokela)
English: Therefore patients should be followed for at least two weeks after hCG administration.
Croatian: Pacijentice stoga treba pratiti najmanje dva tjedna nakon primjene hCG-a.
English: Mild or moderate OHSS usually resolves spontaneously.
Croatian: Blagi ili umjereni OHSS obično prestaje spontano.
English: • You will use these two medicines each day for up to five weeks.
Croatian: • Ta ćete dva lijeka primjenjivati svaki dan tijekom najviše pet tjedana.
English: Following subcutaneous administration, the absolute bioavailability is about 70%.
Croatian: Nakon supkutane primjene, apsolutna bioraspoloživost iznosi oko 70%.
English: Date of latest renewal:
Croatian: Datum posljednje obnove odobrenja:
English: • you have stomach, arm or leg pain.
Croatian: • imate bolove u trbuhu, rukama ili nogama.
English: • If you administer Bemfola to yourself, please carefully read and follow the “Instructions for Use”.
Croatian: • Ako ćete si sami davati lijek Bemfola, pažljivo pročitajte i slijedite „Upute za uporabu”.
English: Tell your doctor straight away if:
Croatian: Odmah obavijestite svojeg liječnika ako primijetite sljedeće:
English: If you use more Bemfola than you should
Croatian: Ako primijenite više lijeka Bemfola nego što ste trebali
English: In adult women
Croatian: U odraslih žena
English: Your doctor will have told you how many IU to inject each day.
Croatian: Liječnik će Vam reći koliko si jedinica (IU) morate ubrizgati svaki dan.
English: In adult women, Bemfola is used:
Croatian: U odraslih žena Bemfola se koristi:
English: Men with hypogonadotropic hypogonadism
Croatian: Muškarci s hipogonadotropnim hipogonadizmom
English: The majority of multiple conceptions are twins.
Croatian: Većina višestrukih začeća rezultira blizancima.
English: • The numbers on the dose display are measured in International Units or IU.
Croatian: • Brojevi u prozorčiću za prikaz doze izraženi su u internacionalnim jedinicama ili IU.
English: In general adequate follicular development is achieved on average by the tenth day of treatment (range 5 to 20 days).
Croatian: Općenito se adekvatni razvoj folikula postiže prosječno 10. dana terapije (raspon je od 5 do 20 dana).
English: • your skin becomes fragile and easily blistered, especially skin that has been frequently in the sun, and/or
Croatian: • koža Vam postaje krhka i lako se stvaraju mjehurići, naročito na mjestima koja su često izložena sunčevoj svjetlosti, i/ili
English: No teratogenic effect has been observed in animal studies (see section 5.3).
Croatian: U ispitivanjima na životinjama nije primijećen teratogeni učinak (vidjeti dio 5.3).
English: Your doctor will use blood tests and/or an ultrasound machine to check when this is.
Croatian: Vaš će liječnik pomoću krvnih pretraga i/ili ultrazvuka provjeriti kada je to postignuto.
English: • Bemfola dose may be increased, depending on your response.
Croatian: • Doza lijeka Bemfola može se povećati, što ovisi o Vašem odgovoru.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital systems, gonadotropins, ATC code: G03GA05.
Croatian: Farmakoterapijska skupina: Spolni hormoni i modulatori spolnog sustava, gonadotropini, ATK oznaka: G03GA05.
English: What Bemfola is and what it is used for
Croatian: Što je Bemfola i za što se koristi
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 posljedica razlika u značajkama roditelja (na primjer: dob majke, značajke sperme) i višeplodnih trudnoća.
English: To minimise skin irritation, select a different injection site each day.
Croatian: Kako biste ublažili nadraživanje kože, svaki dan odaberite drugo mjesto za injiciranje.
English: Perform the injection every day around the same time.
Croatian: Injekciju si dajte svaki dan otprilike u isto vrijeme.
English: If you need to develop several eggs for collection prior to any assisted reproductive technology
Croatian: Ako morate razviti nekoliko jajnih stanica za prikupljanje prije primjene tehnika medicinski potpomognute oplodnje
English: Since these patients are amenorrhoeic and have low endogenous estrogen secretion, treatment can commence at any time.
Croatian: Budući da ove pacijentice pate od amenoreje i imaju slabo lučenje endogenog estrogena, terapija se može započeti u bilo kojem trenutku.
English: • If you have not responded to treatment after 4 months, your doctor may suggest that you continue using these two medicines for at least 18 months.
Croatian: • Ako ne odgovorite na liječenje nakon 4 mjeseca, liječnik će Vam možda predložiti da nastavite primjenjivati ta dva lijeka najmanje 18 mjeseci.
English: Note: The pen is now ready for injection.
Croatian: Napomena: brizgalica je sada spremna za injekciju.
English: What Bemfola looks like and contents of the pack
Croatian: Kako Bemfola izgleda i sadržaj pakiranja
English: Clinical efficacy and safety in men
Croatian: Klinička djelotvornost i sigurnost u muškaraca
English: Semen analysis is recommended 4 to 6 months after the beginning of treatment as part of the assessment of the response.
Croatian: Preporučuje se analizirati sjeme 4 - 6 mjeseci nakon početka terapije, što je dio ocjene odgovora na terapiju.
English: This side effect is very rare
Croatian: Ta je nuspojava vrlo rijetka.
English: • Give yourself the injection around the same time each day.
Croatian: • Injekciju si dajte svaki dan otprilike u isto vrijeme.
English: Bemfola is a biosimilar medicinal product.
Croatian: Bemfola je biosličan lijek.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Croatian: • Periodička izvješća o neškodljivosti Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Caution:
Croatian: Oprez:
English: In these women, the benefits of gonadotropin administration need to be weighed against the risks.
Croatian: U tih žena dobrobiti primjene gonadotropina treba usporediti s rizicima.
English: However, since follitropin alfa is not indicated in pregnancy, these data are of limited clinical relevance.
Croatian: No, budući da folitropin alfa nije indiciran u trudnoći, ovi podaci imaju ograničen klinički značaj.
English: • if you are allergic to follicle stimulating hormone or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na folikulostimulirajući hormon ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
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 trenutno prisutnom tromboembolijskom bolešću ili u žena s opće prepoznatim faktorima rizika za tromboembolijske događaje, kao što su osobna ili obiteljska anamneza, liječenje gonadotropinima može još više povećati rizik od pogoršanja ili pojave takvih događaja.
English: There is evidence to suggest that hCG plays a key role in triggering OHSS and that the syndrome may be more severe and more protracted if pregnancy occurs.
Croatian: Postoje dokazi koji upućuju na to da hCG ima ključnu ulogu u poticanju OHSS-a i da taj sindrom može postati teži te se produžiti ako dođe do trudnoće.
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 tumačio indekse razvoja i sazrijevanja folikula, liječnik mora imati određeno iskustvo u interpretaciji relevantnih testova.
English: What you need to know before you use Bemfola
Croatian: Što morate znati prije nego počnete primjenjivati lijek Bemfola
English: Ectopic pregnancy
Croatian: Ektopična trudnoća
English: It is not yet established whether or not treatment with gonadotropins increases the risk of these tumours in infertile women.
Croatian: Još nije utvrđeno povećava li terapija gonadotropinima rizik od razvoja ovih tumora u neplodnih žena ili ne.
English: Do not use Bemfola if any of the above applies to you.
Croatian: Nemojte primjenjivati lijek Bemfola ako se bilo što od gore navedenog odnosi na Vas.
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, FSH je potreban za rast i razvoj vrećica (folikula) u jajnicima koje sadrže jajne stanice.
English: This is when your follicles develop too much and become large cysts.
Croatian: To je stanje pri kojem se Vaši folikuli prekomjerno razvijaju te postaju velike ciste.
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 davati manje ukupne doze folitropina alfa od doza koje se obično koriste za urinarni FSH, ne samo radi optimiziranja razvoja folikula, nego i radi umanjivanja rizika od neželjene hiperstimulacije jajnika (vidjeti dio 5.1).
English: Overall experience with IVF indicates that in general the treatment success rate remains stable during the first four attempts and gradually declines thereafter.
Croatian: Sveukupno iskustvo s in vitro oplodnjom upućuje na to da stopa uspješnosti terapije općenito ostaje stabilna prilikom prva 4 pokušaja, a potom se postupno smanjuje.
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).
Croatian: 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)
English: The maximal daily dose is usually not higher than 225 IU FSH.
Croatian: Najveća dnevna doza obično nije veća od 225 IU FSH-a.
English: Data on a limited number of exposed pregnant women (less than 300 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of follitropin alfa.
Croatian: Podaci o ograničenom broju izloženih trudnica (manje od 300 ishoda trudnoća) ne pokazuju malformacijski učinak ni fetalnu/neonatalnu toksičnost folitropina alfa.
English: Self-administration of Bemfola should only be performed by patients who are well motivated, adequately trained and have access to expert advice.
Croatian: Samostalna primjena lijeka Bemfola preporučuje se samo kod pacijenata koji su dovoljno motivirani, odgovarajuće podučeni i koji se mogu posavjetovati sa stručnjakom.
English: Clinical efficacy and safety in women
Croatian: Klinička djelotvornost i sigurnost u žena
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27/03/2014
Croatian: Datum prvog odobrenja: 27.03.2014.
English: As the Bemfola pre-filled pen with the single-dose cartridge is intended for only one injection, clear instructions should be provided to the patients to avoid misuse of the single dose presentation.
Croatian: Budući da je napunjena brizgalica s jednodoznim uloškom lijeka Bemfola namijenjena samo za jednu injekciju, pacijentima se moraju dati jasne upute kako bi se izbjegla pogrešna primjena jednodozne formulacije.
English: • if you have a tumour in your hypothalamus or pituitary gland (both are parts of the brain).
Croatian: • ako imate tumor hipotalamusa ili hipofize (oboje su dijelovi mozga)
English: If you are not sure, talk to your doctor or pharmacist before using this medicine.
Croatian: Ako niste sigurni, provjerite sa svojim liječnikom ili ljekarnikom prije nego što primijenite ovaj lijek.
English: Gently tap the pen so that any large air bubbles rise to the top.
Croatian: Nježno lupkajte brizgalicu kako bi se svi veliki mjehurići zraka digli na površinu.
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, menstruacije Vam izostaju i dijagnosticirane su Vam vrlo niske razine hormona FSH ili LH
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: Uobičajeni režim započinje sa 75-150 IU FSH-a na dan te se povećava za 37,5 ili 75 IU u intervalima od 7 ili još bolje 14 dana, po potrebi, kako bi se postigao odgovarajući, ali ne i pretjerani odgovor.
English: BATCH NUMBER<, DONATION AND PRODUCT CODES> Lot
Croatian: 13. BROJ SERIJE <, OZNAKE DONACIJE I PROIZVODA> Serija
English: Do not throw any medicines away via wastewater or household waste.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: If you are developing OHSS your doctor may not give you any hCG in this treatment cycle and you may be told not to have sex or to use a barrier contraceptive method for at least four days.
Croatian: Ako se počine razvijati OHSS, liječnik Vam možda neće dati hCG u tom ciklusu liječenja te će Vas uputiti da se suzdržavate od spolnih odnosa ili koristite mehaničku metodu kontracepcije najmanje četiri dana.
English: Congenital malformation
Croatian: Kongenitalne malformacije
English: • Treatment is continued until your eggs have developed to a desired point.
Croatian: • Liječenje se nastavlja sve dok se jajne stanice ne razviju do željenog stanja.
English: PHARMACEUTICAL FORM Solution for injection (injection).
Croatian: OBLIK Otopina za injekciju (injekcija).
English: This could cause chest pain, breathlessness, stroke or heart attack (see also section 2 under ‘Blood clotting problems').
Croatian: Mogu uzrokovati bol u prsnom košu, nedostatak zraka, moždani ili srčani udar (pogledajte i odlomak „Problemi sa zgrušavanjem krvi“ u dijelu 2.).
English: • Your doctor or nurse will show you how to use the Bemfola pre-filled pen to inject the medicine.
Croatian: • Vaš liječnik ili medicinska sestra pokazat će Vam kako se koristi napunjena brizgalica za injiciranje lijeka Bemfola.
English: Patients must be provided with the correct number of pens for their treatment course and educated to use the proper injection techniques.
Croatian: Pacijentima se mora dati točan broj brizgalica za njihovo liječenje te ih se mora podučiti kako pravilno primjenjivati tehnike ubrizgavanja lijeka.
English: • Serious blood clotting complications (thromboembolic events) sometimes independent of OHSS may be found very rarely (may affect up to 1 in 10,000 people).
Croatian: • Ozbiljne komplikacije zbog zgrušavanja krvi (tromboembolijski događaji) ponekad neovisne o OHSS-u vrlo su rijetke (mogu se javiti u do 1 na 10 000 osoba).
English: If you notice any of the above-listed side effects you should immediately contact your doctor, who might ask you to stop using Bemfola.
Croatian: Ako primijetite bilo koju gore navedenu nuspojavu, odmah se obratite svom liječniku, koji će od Vas možda zatražiti da prestanete uzimati lijek Bemfola.
English: Tell your doctor before you start treatment, if you or any member of your family have porphyria (an inability to break down porphyrins that may be passed on from parents to children).
Croatian: Prije nego što započnete s liječenjem, obavijestite svog liječnika ako bolujete od porfirije ili ako netko u Vašoj obitelji boluje od te bolesti (nesposobnosti razgradnje porfirina, koja se može prenositi s roditelja na djecu).
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: 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 pacijent ne odgovara na terapiju, navedena se kombinacija lijekova može nastaviti primjenjivati; dosadašnje kliničko iskustvo upućuje na to da je za postizanje spermatogeneze ponekad potrebna terapija koja traje najmanje 18 mjeseci.
English: • The active substance is follitropin alfa.
Croatian: • Djelatna tvar je folitropin alfa.
English: Elevated endogenous FSH levels are indicative of primary testicular failure.
Croatian: Povećana razina endogenog FSH-a znak je primarne insuficijencije testisa.
English: • Your asthma may get worse
Croatian: • može doći do pogoršanja astme
English: A certain degree of ovarian enlargement is an expected effect of controlled ovarian stimulation.
Croatian: Određen stupanj povećanja jajnika očekivan je učinak kontrolirane stimulacije jajnika.
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 medicinsko stanje koje se može manifestirati u rastućim stupnjevima težine.
English: • Complications of OHSS such as twisting of ovaries or blood clotting may occur rarely (may affect up to 1 in 1,000 people).
Croatian: • Komplikacije OHSS-a, poput uvrtanja jajnika ili krvnih ugrušaka, su rijetke (mogu se javiti u do 1 na 1 000 osoba).
English: Following intravenous administration, follitropin alfa is distributed to the extracellular fluid space with an initial half-life of around 2 hours and is eliminated from the body with a terminal half-life of about one day.
Croatian: Nakon intravenske primjene, folitropin alfa se raspoređuje u prostor izvanstanične tekućine uz početni poluvijek od približno 2 sata te se eliminira iz tijela uz terminalni poluvijek od približno 1 dana.
English: Mild or moderate OHSS (including associated symptomatology)
Croatian: blagi ili umjereni OHSS (uključujući pridružene simptome)
English: Use the prefilled pen only once then it should be disposed of in a safe manner.
Croatian: Koristite napunjenu brizgalica samo jednom te zatim zbrinite na siguran način.
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 dođe do razvoja teškog oblika OHSS-a, liječenje gonadotropinima treba obustaviti (ako još traje), a pacijenticu hospitalizirati i započeti odgovarajuću terapiju.
English: This gets your eggs ready for collection.
Croatian: Tako će Vaše jajne stanice postati spremne za prikupljanje.
English: • Your dose of Bemfola may be increased every 7 or every 14 days by 37.5 to 75 IU, until you get the desired response or your doctor tells you to stop, see below.
Croatian: • Vaša doza lijeka Bemfola može se povećati svakih 7 ili svakih 14 dana za 37,5 - 75 IU, sve dok ne postignete željeni odgovor ili vam liječnik kaže da prekinete, pogledajte dolje.
English: Driving and using machines It is not expected that this medicine will affect your ability to drive and use machines.
Croatian: Ne očekuje se da će ovaj lijek utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
English: In menstruating women treatment should commence within the first 7 days of the menstrual cycle.
Croatian: U pacijentica s menstruacijom terapiju treba započeti unutar prvih 7 dana od početka menstrualnog ciklusa.
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 primjenjivati u dozi od 150 IU tri puta tjedno, istodobno s hCG-om, kroz najmanje 4 mjeseca.
English: In women, the most important effect resulting from parenteral administration of FSH is the development of mature Graafian follicles.
Croatian: U žena je najvažniji učinak koji proizlazi iz parenteralne primjene FSH-a razvoj zrelih Graafovih folikula.
English: Porphyria
Croatian: Porfirija
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 zahtijeva određenu vremensku obvezu liječnika i pomoćnih zdravstvenih djelatnika te postojanje odgovarajuće opreme i mogućnosti praćenja postupka liječenja neplodnosti.
English: If you do not have periods you can start using the medicine on any convenient day.
Croatian: Ako menstruacija izostaje, možete početi primjenjivati lijek bilo koji dan.
English: In case you are not ovulating, and if the recommended dose and schedule of administration are adhered to, the occurrence of OHSS is less likely.
Croatian: Ako nemate ovulaciju i pridržavate se preporučene doze i rasporeda primjene lijeka, pojava OHSS-a malo je vjerojatna.