FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment is continued until adequate follicular development has been achieved (as assessed by monitoring of serum estrogen concentrations and/or ultrasound examination), with the dose adjusted according to the patient's response, to usually not higher than 450 IU daily.
Croatian: Liječenje se nastavlja sve dok se ne postigne odgovarajući razvoj folikula (što se ocjenjuje praćenjem koncentracije estrogena u serumu i/ili pregledom ultrazvukom), a doza se prilagođava ovisno o odgovoru pacijentice, obično do maksimalno 450 IU na dan.
English: After the withdrawal of the needle: clean the skin with an alcohol swab using a circular motion.
Croatian: Nakon uklanjanja igle: očistite kožu jastučićem od vate natopljenog alkoholom kružnim pokretima.
English: If your doctor decides to try Bemfola treatment, to monitor the treatment, they may ask you to provide semen for analysis 4 to 6 months after starting treatment.
Croatian: Ako Vaš liječnik odluči pokušati liječenje lijekom Bemfola, možda će od Vas zatražiti uzorak sjemena za analizu 4 - 6 mjeseci nakon početka terapije kako bi mogao pratiti liječenje.
English: Blood clotting problems (thromboembolic events)
Croatian: Problemi sa zgrušavanjem krvi (tromboembolije)
English: A recommended regimen commences at 75 IU of lutropin alfa daily with 75-150 IU FSH.
Croatian: Preporučeni režim terapije započinje sa 75 IU lutropina alfa dnevno, zajedno sa 75-150 IU FSH-a.
English: Follitropin alfa should not be used when an effective response cannot be obtained.
Croatian: Folitropin alfa ne smije se koristiti kada se ne može postići učinkovit odgovor.
English: The used pen needs to be discarded in a sharps container and returned to the pharmacy for a correct disposal.
Croatian: Upotrijebljenu brizgalicu treba odložiti u spremnik za oštre predmete i vratiti u ljekarnu radi pravilnog zbrinjavanja.
English: The dose recommendations given for follitropin alfa are those in use for urinary FSH.
Croatian: Navedene preporučene doze za folitropin alfa su one koje se inače koriste za urinarni FSH.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1, 5 OR 10 PRE-FILLED PENS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S 1, 5 ILI 10 NAPUNJENIH BRIZGALICA
English: • Bemfola is presented as a clear, colourless liquid for injection in a pre-filled pen (injection).
Croatian: • Bemfola je bistra, bezbojna tekućina za injekciju u napunjenoj brizgalici (injekciji).
English: Mild or moderate ovarian hyperstimulation syndrome (OHSS) has been commonly reported and should be considered as an intrinsic risk of the stimulation procedure.
Croatian: Često je prijavljen blag ili umjeren sindrom hiperstimulacije jajnika (OHSS), koji treba smatrati intrinzičnim rizikom postupka stimulacije.
English: Patients with porphyria or a family history of porphyria should be closely monitored during treatment with follitropin alfa.
Croatian: Pacijente koji boluju od porfirije ili imaju porfiriju u obitelji treba pažljivo pratiti za vrijeme liječenja folitropinom alfa.
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 upućuje na to da se njegove dnevne doze, režimi primjene i metode praćenja terapije ne bi trebali razlikovati od onih koji se trenutno koriste za pripravke koji sadrže urinarni FSH.
English: Severe OHSS (including associated symptomatology) (see section 4.4)
Croatian: teški OHSS (uključujući i pridružene simptome) (vidjeti dio 4.4)
English: The lowest effective dose in relation to the treatment objective should be used in both men and women.
Croatian: I kod žena i kod muškaraca treba koristiti najnižu učinkovitu dozu u odnosu na cilj terapije.
English: If you are a man, having too much FSH in your blood can be a sign of damaged testicles.
Croatian: Ako ste muškarac, povećana razina folikulostimulirajućeg hormona u krvi može biti znak oštećenja testisa.
English: • Before starting to use your pre-filled pen, please read these instructions and the package leaflet the whole way through first.
Croatian: • Prije početka korištenja napunjene brizgalice prvo pročitajte ove upute i upute o lijeku do kraja.
English: There is no indication for use of follitropin alfa during pregnancy.
Croatian: Ne postoji indikacija za korištenje folitropina alfa tijekom trudnoće.
English: You can reduce the risk of multiple pregnancy by using the right dose of Bemfola at the right times.
Croatian: Rizik od višeplodne trudnoće možete smanjiti ako primjenjujete preporučene doze lijeka Bemfola u pravo vrijeme.
English: • The first injection of Bemfola should be given under supervision of your doctor.
Croatian: • Prvu injekciju lijeka Bemfola treba primijeniti pod izravnim nadzorom Vašeg liječnika.
English: It is more commonly seen in women with polycystic ovarian syndrome and usually regresses without treatment.
Croatian: Češći je u žena sa sindromom policističnih jajnika te obično prolazi bez liječenja.
English: Adherence to the recommended follitropin alfa dose and regimen of administration, and careful monitoring of therapy will minimise the incidence of such events.
Croatian: Pridržavanje preporučene doze i režima primjene folitropina alfa te pažljivo praćenje terapije smanjit će incidenciju takvih pojava.
English: * recombinant human follicle stimulating hormone (r-hFSH) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Croatian: * rekombinantni humani folikulostimulirajući hormon (r-hFSH), proizveden u stanicama jajnika kineskog hrčka (CHO) tehnologijom rekombinantne DNK.
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 nema povoljnog odgovora pacijentice nakon 4 tjedna od početka terapije, taj ciklus treba prekinuti i napraviti daljnju procjenu stanja pacijentice, nakon čega pacijentica može ponovno započeti terapiju većom početnom dozom od one u prekinutom ciklusu.
English: Still holding the pen upright, push the dosage knob in until the activation bar with the small arrow disappears.
Croatian: Držeći i dalje brizgalicu uspravno, pritišćite dugme za doziranje sve dok više ne bude vidljiva aktivacijska traka s malom strelicom.
English: Alternatively, intrauterine insemination may be performed by placing the sperm into the womb cavity.
Croatian: Alternativa je provođenje intrauterine inseminacije umetanjem sperme u maternicu.
English: How much to use
Croatian: Koliko lijeka trebate primijeniti
English: In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of follitropin alfa.
Croatian: U slučaju primjene za vrijeme trudnoće, ne postoji dovoljno kliničkih podataka kojima bi se isključio teratogeni učinak folitropina alfa.
English: Treatment in men
Croatian: Liječenje muškaraca
English: Adherence to the recommended follitropin alfa dose and to the regimen of administration can minimise the risk of ovarian hyperstimulation (see sections 4.2 and 4.8).
Croatian: Pridržavanjem preporučenih doza i režima primjene folitropina alfa minimizira se rizik od hiperstimulacije jajnika (vidjeti dijelove 4.2 i 4.8).
English: • If you have irregular periods, start using Bemfola within the first 7 days of your menstrual cycle.
Croatian: • Ako imate neredovite menstruacije, počnite primjenjivati lijek Bemfola unutar prvih 7 dana menstruacijskog ciklusa.
English: Follitropin alfa is a potent gonadotrophic substance capable of causing mild to severe adverse reactions, and should only be used by physicians who are thoroughly familiar with infertility problems and their management.
Croatian: Folitropin alfa snažna je gonadotropna tvar sposobna izazvati blage do teške nuspojave i trebaju je primjenjivati samo oni liječnici koji su detaljno upoznati s problemima neplodnosti i njihovim liječenjem.
English: In a commonly used protocol, follitropin alfa is started approximately 2 weeks after the start of agonist treatment, both being continued until adequate follicular development is achieved.
Croatian: Prema uobičajenom protokolu, terapija folitropinom alfa započinje približno 2 tjedna nakon početka terapije agonistom, a oba se lijeka nastavljaju primjenjivati sve dok se ne postigne zadovoljavajući razvoj folikula.
English: • OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty in breathing and/or possible fluid accumulation in your stomach or chest.
Croatian: • OHSS može postati težak uz jasno uvećane jajnike, smanjeno stvaranje mokraće, povećanje tjelesne težine, poteškoće pri disanju i/ili moguće nakupljanje tekućine u trbuhu ili prsnom košu.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance Polymun Scientific Immunbiologische Forschung GmbH Donaustraße 99
Croatian: Polymun Scientific Immunbiologische Forschung GmbH Donaustraße 99
English: If you forget to use Bemfola
Croatian: Ako ste zaboravili primijeniti lijek Bemfola
English: When undergoing assisted reproductive technology or stimulation of your ovaries to produce eggs, you are more likely to have a miscarriage than the average woman.
Croatian: Kada se podvrgavate tehnikama medicinski potpomognute oplodnje ili poticanju rada jajnika radi stvaranja jajnih stanica, vjerojatnije ćete doživjeti spontani pobačaj nego prosječna žena.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity and genotoxicity in addition to those already stated in the other sections of this SmPC.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti pojedinačnih i ponovljenih doza i genotoksičnosti osim onih navedenih u drugim dijelovima ovog sažetka opisa svojstava lijeka.
English: The different parts of your pen
Croatian: Različiti dijelovi brizgalice
English: The first injection of Bemfola should be performed under direct medical supervision.
Croatian: Prvu injekciju lijeka Bemfola treba primijeniti pod izravnim nadzorom liječnika.
English: Do not use this medicine if you notice any visible signs of deterioration, if the liquid contains particles or is not clear.
Croatian: Lijek se ne smije upotrijebiti ako primijetite vidljive znakove kvarenja ili ako tekućina sadrži čestice ili nije bistra.
English: If you are not ovulating and have irregular or no periods
Croatian: Žene Ako nemate ovulacije i imate neredovite menstruacije ili izostanak menstruacije
English: Serious side effects in men and women
Croatian: Ozbiljne nuspojave u muškaraca i žena
English: To minimise the risk of multiple pregnancy, careful monitoring of ovarian response is recommended.
Croatian: Kako bi se minimizirao rizik od višeplodnih trudnoća, preporučuje se pažljivo praćenje odgovora jajnika.
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: Među pacijentima mogu postojati razlike u odgovoru na FSH, pri čemu je kod nekih pacijenata moguć slab odgovor na FSH, a kod drugih pak pretjeran odgovor.
English: This may indicate that the ovaries over-reacted to the treatment and that large ovarian cysts developed (see also section 2 “Take special care with Bemfola”).
Croatian: To može značiti da su jajnici prekomjerno reagirali na liječenje te da su nastale velike ciste na jajnicima (pogledajte odlomak „Budite posebno oprezni s lijekom Bemfola“ u dijelu 2.).
English: Push in the dosage knob slowly and continuously until it stops, and the dose bar has disappeared.
Croatian: Polako i neprekidno pritišćite dugme za doziranje dok se ono ne zaustavi, a traka za doziranje više ne bude vidljiva.
English: Ovarian Hyperstimulation Syndrome (OHSS)
Croatian: Sindrom hiperstimulacije jajnika (OHSS)
English: For instructions on the administration with the pre-filled pen, see section 6.6 and the package leaflet.
Croatian: Za upute o primjeni napunjenom brizgalicom vidjeti dio 6.6 i Uputu o lijeku.
English: • Bemfola is supplied in packs with 1, 5 or 10 pre-filled pens, 1, 5 or 10 disposable needles and 1,
Croatian: • Bemfola se isporučuje u pakiranjima s 1, 5 ili 10 napunjenih brizgalica, 1, 5 ili 10
English: The safety and efficacy of follitropin alfa in elderly patients have not been established.
Croatian: Sigurnost i učinkovitost folitropina alfa u pacijenata starije dobi nisu ustanovljene.
English: Follitropin alfa should be given as a course of daily injections simultaneously with lutropin alfa.
Croatian: Folitropin alfa treba primjenjivati u obliku dnevnih injekcija istodobno s lutropinom alfa.
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, no ipak postoji mogućnost pojave OHSS-a (vidjeti dio 4.4).
English: Monitoring of stimulation cycles by ultrasound scans as well as oestradiol measurements are recommended to early identify risk factors.
Croatian: Preporučuje se praćenje ciklusa stimulacije pregledima ultrazvukom i mjerenjima razine estradiola za rano prepoznavanje faktora rizika.
English: When using Bemfola, you have a higher risk of being pregnant with more than one child at the same time (“multiple pregnancy”, mostly twins), than if you conceive naturally.
Croatian: Tijekom primjene lijeka Bemfola postoji veća vjerojatnost za višeplodne trudnoće („višestruka trudnoća“, uglavnom blizanci) nego kod prirodnog začeća.
English: Such patients are unresponsive to follitropin alfa/hCG therapy.
Croatian: Ovi pacijenti ne reagiraju na terapiju folitropinom alfa/hCG-om.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati (navesti) u zdravstvenom kartonu bolesnika.
English: These instructions can be found at the end of the package leaflet.
Croatian: Te se upute nalaze na kraju Upute o lijeku.
English: • Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT).
Croatian: • Stimulacija razvoja većeg broja folikula u žena kod kojih se stimulira superovulacija za metode medicinski potpomognute oplodnje kao što su in vitro umjetna oplodnja (engl. in vitro fertilisation, IVF), transfer gamete u jajovod (engl. gamete intra-fallopian transfer, GIFT) i transfer zigote u jajovod (engl. zygote intra-fallopian transfer, ZIFT).
English: Table 1: Results of study GF 8407 (randomised parallel group study comparing efficacy and safety of follitropin alfa with urinary FSH in assisted reproduction technologies) follitropin alfa (n = 130)
Croatian: Tablica 1: Rezultati ispitivanja GF 8407 (randomizirano ispitivanje s usporednim skupinama koja je uspoređivalo djelotvornost i sigurnost folitropina alfa s onima urinarnog FSH-a pri medicinski potpomognutoj oplodnji)
English: Caution: Do not push the dosage knob, while inserting the needle.
Croatian: Oprez: ne pritišćite dugme za doziranje prilikom uvođenja igle.
English: The safety, efficacy and pharmacokinetics of follitropin alfa in patients with renal or hepatic impairment have not been established.
Croatian: Sigurnost, djelotvornost i farmakokinetika folitropina alfa u pacijenata s oštećenjem funkcije bubrega ili jetre nisu ustanovljene.
English: It comprises marked ovarian enlargement, high serum sex steroids, and an increase in vascular permeability which can result in an accumulation of fluid in the peritoneal, pleural and, rarely, in the pericardial cavities.
Croatian: Uključuje izraženo povećanje jajnika, visoku razinu spolnih steroidnih hormona u serumu i povećanje vaskularne propusnosti, čija posljedica može biti nakupljanje tekućine u peritonealnoj, pleuralnoj, a rijetko i u perikardijalnoj šupljini.
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.
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.
English: Follitropin alfa must not be used when an effective response cannot be obtained, such as in cases of:
Croatian: Folitropin alfa ne smije se koristiti kada se ne može postići učinkovit odgovor, primjerice, u sljedećim slučajevima:
English: In women, safe and effective use of follitropin alfa calls for monitoring of the ovarian response with ultrasound, alone or preferably in combination with measurement of serum estradiol levels, on a regular basis.
Croatian: U žena, sigurna i učinkovita primjena folitropina alfa iziskuje redovito praćenje odgovora jajnika ultrazvukom, samostalno ili po mogućnosti u kombinaciji s mjerenjem razine estradiola u serumu.
English: The maximum daily dose is 450 IU (0.75 mL).
Croatian: Najveća dnevna doza iznosi 450 IU (0,75 ml).
English: • Lower abdominal pain together with nausea or vomiting may be the symptoms of Ovarian Hyper-Stimulation Syndrome (OHSS).
Croatian: • Bol u donjem dijelu trbuha uz mučninu ili povraćanje može biti simptom sindroma hiperstimulacije jajnika (OHSS).
English: • Your doctor/pharmacist will tell you how many Bemfola pens you need to use for your complete treatment course.
Croatian: • Liječnik/ljekarnik će Vam reći koliko Vam je brizgalica s lijekom Bemfola potrebno za cjelokupan ciklus liječenja.
English: In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/L.
Croatian: U kliničkim ispitivanjima te su pacijentice definirane razinom endogenog LH-a u serumu < 1,2 IU/l.
English: Do not use this medicine after the expiry date, which is stated on the pen label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici brizgalice ili kutiji iza oznake „Rok valjanosti“ (EXP).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED PEN LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NAPUNJENE BRIZGALICE
English: In case of the above events your doctor may recommend that you stop treatment.
Croatian: Liječnik će Vam u tim slučajevima možda savjetovati prekid liječenja.
English: Throw away the packaging box, inner needle cap, peel tab, alcohol swab and the instructions for use in the normal household waste.
Croatian: Odložite ambalažu, unutarnji zatvarač igle, zaštitnu foliju, jastučić od vate natopljen alkoholom i upute za uporabu u običan kućni otpad.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA
English: The Bemfola and GnRH agonist are then both given until your follicles develop as desired.
Croatian: GnRH-a zatim se primjenjuju zajedno sve dok se folikuli ne razviju na željeni način.
English: Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: • The maximum daily dose of Bemfola is usually not higher than 225 IU (0.375 mL).
Croatian: • Najveća dnevna doza lijeka Bemfola obično nije veća od 225 IU (0,375 ml).
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodiumfree”.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events such as pulmonary embolism, ischaemic stroke or myocardial infarction.
Croatian: Vrlo rijetko, teški OHSS može biti popraćen komplikacijama kao što su torzija jajnika ili tromboembolijski događaji poput plućne embolije, ishemijskog moždanog udara ili infarkta miokarda.
English: Pregnancy loss
Croatian: Gubitak trudnoće
English: In patients undergoing ovulation induction, the incidence of a multiple pregnancy is increased compared with natural conception.
Croatian: U pacijentica koje su podvrgnute indukciji ovulacije povećana je incidencija višeplodnih trudnoća u usporedbi s prirodnim začećem.
English: Treatment in women
Croatian: Liječenje žena
English: Turn the dosage knob until your prescribed dose is in line with the display window.
Croatian: Okrećite dugme za doziranje sve dok se u prozorčiću za prikaz doze ne prikaže doza koja Vam je propisana.
English: In women whose endogenous gonadotropin secretion is suppressed, follitropin alfa has nevertheless been shown to effectively stimulate follicular development and steroidogenesis, despite unmeasurable LH levels.
Croatian: U žena sa supresijom lučenja endogenog gonadotropina, pokazalo se da folitropin alfa ipak učinkovito stimulira razvoj folikula i steroidogenezu, unatoč nemjerljivim razinama LH-a.
English: Bemfola is intended for subcutaneous use.
Croatian: Bemfola je namijenjena potkožnoj primjeni.
English: In other cases, your doctor may first stop you from ovulating by using a gonadotropin-releasing hormone (GnRH) agonist or antagonist.
Croatian: U ostalim slučajevima, liječnik prvo može zaustaviti ovulaciju primjenom agonista ili antagonista hormona koji oslobađa gonadotropin (GnRH).
English: Instructions for use
Croatian: Upute za primjenu
English: What Bemfola contains
Croatian: Što Bemfola sadrži
English: Clinical evaluation may reveal hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, or acute pulmonary distress.
Croatian: Klinička procjena može otkriti hipovolemiju, hemokoncentraciju, poremećaj ravnoteže elektrolita, ascites, krv u trbušnoj šupljini, pleuralni izljev, hidrotoraks ili akutni respiratorni distres.
English: Using this medicine
Croatian: Primjena ovog lijeka
English: One-eighth of the follitropin alfa dose is excreted in the urine.
Croatian: Jedna osmina doze folitropina alfa izlučuje se u mokraću.
English: Other side effects in men
Croatian: Ostale nuspojave u muškaraca
English: The patients should be advised of the potential risk of multiple births before starting treatment.
Croatian: Prije početka terapije, pacijentice treba upozoriti na potencijalan rizik od rođenja većeg broja djece.
English: The following symptomatology may be observed in severe cases of OHSS: abdominal pain, abdominal distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea.
Croatian: U teškim slučajevima OHSS-a mogu se uočiti sljedeći simptomi: bol u abdomenu, distenzija abdomena, veliko povećanje jajnika, povećanje tjelesne težine, dispneja, oligurija i gastrointestinalni simptomi, uključujući mučninu, povraćanje i proljev.
English: • together with another medicine called “lutropin alfa” (“luteinising hormone” or LH) to help release an egg from the ovary (ovulation) in women that are not ovulating because their body is producing very little gonadotropins (FSH and LH).
Croatian: • zajedno s još jednim hormonom, „lutropinom alfa“ („luteinizirajući hormon“ ili LH), s ciljem poticanja otpuštanja jajne stanice iz jajnika (ovulacije) u žena koje ne ovuliraju zato što im tijelo proizvodi vrlo malo gonadotropina (FSH i LH).
English: Elderly population
Croatian: Starije osobe
English: Now you are ready to immediately give yourself the injection: Your doctor or nurse will have already advised you where to inject (e.g. tummy, front of thigh).
Croatian: Vaš liječnik ili medicinska sestra su Vam već savjetovali gdje trebate dati injekciju (npr. trbuh, prednji dio bedra).