FrancophonIA/ELRC3.0 huggingface dataset:
English: In ART there is an increased risk of OHSS with 18 or more follicles of 11 mm or more in diameter.
Croatian: Kod medicinski potpomognute oplodnje postoji povećan rizik od OHSS-a s 18 ili više folikula promjera 11 mm ili više.
English: The concurrent determination of serum oestradiol levels may also be useful.
Croatian: Istodobno određivanje koncentracije estradiola u serumu također može biti korisno.
English: Therefore, your doctor should perform an early ultrasound examination to exclude the possibility of pregnancy outside the uterus.
Croatian: Stoga Vaš liječnik mora napraviti rani pregled ultrazvukom kako bi isključio mogućnost izvanmaternične trudnoće.
English: If you are breast-feeding, tell your doctor before using Fertavid.
Croatian: Ako dojite, obavijestite o tome svog liječnika prije uzimanja lijeka Fertavid.
English: It was shown that on average an 18% higher amount of FSH is given with the pen compared with a conventional syringe.
Croatian: Pokazalo se da se brizgalicom injicira prosječno 18% veća količina FSH-a nego običnom štrcaljkom.
English: When using the pen injector, it should be realised that the pen is a precision device which accurately delivers the dose to which it is set.
Croatian: Kod uporabe injekcijske brizgalice treba znati da je brizgalica precizno pomagalo koje injicira točnu dozu koja je odmjerena.
English: In addition, before starting to use this medicine, tell your doctor if you:
Croatian: Dodatno, prije nego počnete primjenjivati ovaj lijek, obavijestite svog liječnika:
English: Usually, 7 to 14 days of treatment is sufficient to reach this state.
Croatian: Za postizanje ovog stanja obično je dostatno 7 do 14 dana liječenja.
English: Fertavid is used to treat infertility in any of the following situations:
Croatian: Fertavid se koristi za liječenje neplodnosti u sljedećim situacijama:
English: A gentle massage of the site - while still maintaining pressure - helps disperse the Fertavid solution and relieve any discomfort.
Croatian: Nježna masaža mjesta uboda, uz zadržavanje pritiska, poboljšava raspodjelu Fertavid otopine i ublažava neugodu.
English: When ultrasound assessment indicates the presence of at least three follicles of 16-20 mm, and there is evidence of a good oestradiol response (plasma levels of about 300-400 picograms/mL (1,000-1,300 pmol/L) for each follicle with a diameter greater than 18 mm), the final phase of maturation of the follicles is induced by administration of hCG. Oocyte retrieval is performed 34-35 hours later.
Croatian: Kad se ultrazvučno dokaže prisutnost najmanje tri folikula promjera 16-20 mm, uz dobar odgovor estradiola (razine u plazmi od oko 300400 pikograma/ml (1000-1300 pmol/l) za svaki folikul promjera većeg od 18 mm), potiče se posljednja faza sazrijevanja folikula primjenom hCG-a.
English: Any blood sucked back into the syringe means that the needle tip has penetrated a vein or artery.
Croatian: Ako u štrcaljku uvučete malo krvi, to znači da je vrh igle probio venu ili arteriju.
English: Clinical signs and symptoms of severe OHSS are large ovarian cysts, acute abdominal pain, ascites, pleural effusion, hydrothorax, dyspnoea, oliguria, haematological abnormalities and weight gain.
Croatian: Klinički znakovi i simptomi teškog OHSS-a su velike ciste jajnika, akutna bol u abdomenu, ascites, pleuralni izljev, hidrotoraks, dispneja, oligurija, hematološki poremećaji i povećanje tjelesne težine.
English: Treatment with Fertavid should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Croatian: Liječenje lijekom Fertavid mora se započeti pod nadzorom liječnika s iskustvom u liječenju problema neplodnosti.
English: follitropin beta (n = 546)
Croatian: folitropin beta (n = 546)
English: This serious medical condition is called ovarian hyperstimulation syndrome (OHSS).
Croatian: To se ozbiljno medicinsko stanje zove sindrom hiperstimulacije jajnika (OHSS).
English: If there is no ovarian response, the daily dose is then gradually increased until follicle growth and/or plasma oestradiol levels indicate an adequate pharmacodynamic response.
Croatian: Ako nema odgovora jajnika, dnevna doza se postupno povećava sve dok rast folikula i/ili razine estradiola u plazmi ne ukažu na odgovarajući farmakodinamički odgovor.
English: If you forget to use Fertavid
Croatian: Ako ste zaboravili primijeniti Fertavid
English: Fertavid is used in the treatment of women undergoing ovarian induction or controlled ovarian hyperstimulation in assisted reproduction programmes.
Croatian: Fertavid se koristi u liječenju žena koje su podvrgnute poticanju ili kontroliranoj hiperstimulaciji jajnika u sklopu postupaka medicinski potpomognute oplodnje.
English: Step 7 - Removing the syringe
Croatian: Korak 7 - Odstranjivanje štrcaljke
English: Pack of 1, 5 or 10 vials.
Croatian: Pakiranja od 1, 5 i 10 bočica.
English: This may be of particular relevance when switching between the pen injector and a conventional syringe within one treatment cycle.
Croatian: To može biti naročito važno ako se u istom ciklusu naizmjence koriste brizgalica i obična štrcaljka.
English: In rare instances, venous or arterial thromboembolism may occur in association with OHSS.
Croatian: U rijetkim slučajevima može nastati venska ili arterijska tromboembolija povezana s OHSS-om.
English: FSH is indispensable in normal follicular growth and maturation, and gonadal steroid production.
Croatian: FSH je neophodan za normalni rast i sazrijevanje folikula kao i za proizvodnju steroida u gonadama.
English: • Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)].
Croatian: • Kontrolirana hiperstimulacija jajnika radi poticanja razvoja višestrukih folikula u sklopu postupaka medicinski potpomognute oplodnje [npr. in vitro oplodnja/prijenos embrija (engl. in vitro fertilisation/embryo transfer, IVF/ET), prijenos gamete u jajovod (engl. gamete intrafallopian transfer, GIFT) i intracitoplazmatsko injiciranje spermija (engl. intracytoplasmic sperm injection, ICSI)].
English: The active substance follitropin beta.
Croatian: Djelatna tvar je folitropin beta.
English: Furthermore Fertavid can be used to promote multiple follicular development in medically assisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intrafallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)].
Croatian: Nadalje, Fertavid se može koristiti za poticanje razvoja većeg broja folikula u postupcima medicinski potpomognute oplodnje [npr. in vitro oplodnja/prijenos embrija (IVF/ET), prijenos gamete u jajovod (GIFT) ili intracitoplazmatsko injiciranje spermija (ICSI)].
English: A few taps at the injection site will stimulate tiny nerve endings and help reduce discomfort when the needle goes in. Wash your hands and swab the injection site with disinfectant (for example chlorohexidine 0.5%) to remove any surface bacteria.
Croatian: Operite ruke i obrišite mjesto injiciranja sredstvom za dezinfekciju (npr. kloroheksidinom 0,5%) kako biste uklonili površinske bakterije.
English: Fertavid solution for injection contains follitropin beta, a hormone known as follicle-stimulating hormone (FSH).
Croatian: Fertavid otopina za injekciju sadrži folitropin beta, hormon poznat kao folikulostimulirajući hormon (FSH).
English: In the female the level of FSH is critical for the onset and duration of follicular development, and consequently for the timing and number of follicles reaching maturity.
Croatian: U žena je razina FSH-a ključna za početak i duljinu folikularnog razvoja te posljedično za trenutak sazrijevanja i broj folikula koji će sazrijeti.
English: Pregnancy outside the uterus (an ectopic pregnancy), miscarriage and multiple pregnancies have also been reported.
Croatian: Također su prijavljeni izvanmaternična trudnoća (ektopična trudnoća), pobačaj i višeplodna trudnoća.
English: Do not mix Fertavid with any other medicines.
Croatian: Fertavid se ne smije miješati s drugim lijekovima.
English: Place a needle on a syringe and pierce the needle through the rubber stopper of the vial (a).
Croatian: Nataknite iglu na štrcaljku i probodite gumeni čep bočice (a).
English: Fertavid is usually prescribed at a dose of 450 IU per week, mostly in 3 dosages of 150 IU, in combination with another hormone (hCG), for at least 3 to 4 months.
Croatian: Fertavid se obično daje u dozi od 450 IU tjedno, većinom u tri odijeljene doze od 150 IU, u kombinaciji s drugim hormonom (hCG).
English: Subcutaneous injection of Fertavid may be carried out by patient or partner, provided that proper instructions are given by the physician.
Croatian: Supkutanu injekciju lijeka Fertavid može primijeniti sam bolesnik/bolesnica ili partner/partnerica ako im je liječnik dao odgovarajuće upute.
English: • Tumours of the ovary, breast, uterus, testis, pituitary or hypothalamus.
Croatian: • Tumori jajnika, dojke, uterusa, testisa, hipofize ili hipotalamusa.
English: Fertavid solution for injection comes in a glass vial.
Croatian: Fertavid otopina za injekciju nalazi se u staklenoj bočici.
English: Other Medical Conditions
Croatian: Druga medicinska stanja
English: A complication with FSH treatment is hyperstimulation of the ovaries.
Croatian: Komplikacija liječenja FSH-om je hiperstimulacija jajnika.
English: Table 1: Results of study 37,608 (randomized, group comparative clinical study comparing safety and efficacy of follitropin beta with urinary FSH in controlled ovarian stimulation).
Croatian: Tablica 1: Rezultati Ispitivanja 37 608 (randomizirano, grupno komparativno kliničko ispitivanje usporedbe sigurnosti i djelotvornosti lijeka folitropin beta i urinarnog FSH-a u kontroliranoj stimulaciji jajnika).
English: If you inject yourself with Fertavid, follow the instructions for use in the next section, to give Fertavid properly and with minimal discomfort.
Croatian: Ako sami injicirate Fertavid, slijedite upute za primjenu u daljnjem tekstu kako biste Fertavid primijenili pravilno i uz minimalnu neugodu.
English: Table 2: Results of study 37,609 (randomized, group comparative clinical study comparing safety and efficacy of follitropin beta with urinary FSH in ovulation induction).
Croatian: Tablica 2: Rezultati Ispitivanja 37 609 (randomizirano, grupno komparativno kliničko ispitivanje usporedbe sigurnosti i djelotvornosti lijeka folitropin beta i urinarnog FSH-a u poticanju ovulacije).
English: After subcutaneous administration of Fertavid, maximum concentration of FSH is reached within about 12 hours.
Croatian: Nakon supkutane primjene lijeka Fertavid maksimalna koncentracija FSH-a postiže se unutar otprilike 12 sati.
English: OHSS is a medical event distinct from uncomplicated ovarian enlargement.
Croatian: Ovarian Hyperstimulation Syndrome, OHSS) OHSS je medicinski događaj koji se razlikuje od nekompliciranog povećanja jajnika.
English: Thrombosis is the formation of a blood clot in a blood vessel.
Croatian: Tromboza je stvaranje krvnih ugrušaka u krvnim žilama.
English: Such patients are unresponsive to Fertavid/hCG therapy.
Croatian: Takvi bolesnici neće odgovoriti na liječenje lijekom Fertavid i hCG-om.
English: After intramuscular or subcutaneous administration of Fertavid, maximum concentrations of FSH are reached within about 12 hours.
Croatian: Nakon intramuskularne ili supkutane primjene lijeka Fertavid maksimalne koncentracije FSH-a postižu se unutar otprilike 12 sati.
English: • Medically assisted reproduction programs, for instance IVF A starting dose is set by your doctor.
Croatian: • Postupci medicinski potpomognute oplodnje, npr. izvantjelesna oplodnja (IVF) Liječnik će odrediti početnu dozu.
English: It is available in packs of 1, 5 or 10 vials.
Croatian: Dostupna je u staklenim bočicama, u pakiranjima od 1, 5 ili 10 bočica.
English: Do not use Fertavid
Croatian: Nemojte primjenjivati Fertavid
English: The incidence of congenital malformations after ART may be slightly higher than after spontaneous conceptions.
Croatian: Incidencija prirođenih malformacija nakon postupka potpomognute oplodnje može biti neznatno veća nego nakon spontanog začeća.
English: Fertavid should be given at a dosage of 450 IU/week, preferably divided in 3 dosages of 150 IU, concomitantly with hCG.
Croatian: Fertavid se mora davati u dozi od 450 IU/tjedan, preporučljivo u 3 odijeljene doze od 150 IU, istodobno uz hCG.
English: Before starting to use this medicine, tell your doctor if you:
Croatian: Prije nego počnete primjenjivati ovaj lijek, obavijestite svog liječnika:
English: Call your doctor right away if you notice severe abdominal swelling, pain in the stomach area (abdomen), feeling sick (nausea), vomiting, sudden weight gain due to fluid buildup, diarrhoea, decreased urine output or trouble breathing (see also section 4 on Possible side effects).
Croatian: Ako primijetite jako napuhnut trbuh, bol u području trbuha (abdomena), mučninu, povraćanje, iznenadno povećanje tjelesne težine zbog nakupljanja tekućine, proljev, smanjeno mokrenje ili otežano disanje, odmah se javite liječniku (također pogledajte dio 4 Moguće nuspojave).
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva često akne osip
English: If there is no ovarian response, the daily dose will then be gradually increased until follicle growth and/or plasma oestradiol levels indicate a proper response.
Croatian: Ako nema odgovora jajnika, dnevna doza će se postupno povećavati dok rast folikula i/ili koncentracije estradiola u plazmi ne ukažu na dobar odgovor.
English: The subcutaneous injection site should be alternated to prevent lipoatrophy.
Croatian: Mjesto supkutane primjene se mora mijenjati kako bi se spriječila lipoatrofija.
English: Primary Testicular Failure
Croatian: Primarno zatajenje testisa
English: Twisting of the ovary could cause the blood flow to the ovary to be cut off.
Croatian: Uvrtanje jajnika može prekinuti dotok krvi u jajnik.
English: The injection site should be alternated to prevent lipoatrophy.
Croatian: Mjesto primjene se mora mijenjati kako bi se spriječila lipoatrofija.
English: For males and females • 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: The treatment period equals the development time of sperm and the time in which improvement can be expected.
Croatian: Liječenje traje najmanje 3-4 mjeseca, što odgovara vremenu potrebnom za razvoj spermija i vremenu u kojemu se može očekivati poboljšanje.
English: • have fibroid tumours in the uterus which make a normal pregnancy impossible
Croatian: • ako imate fibroidne tumore maternice koji onemogućavaju normalnu trudnoću
English: In males Fertavid is used in the treatment of deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Croatian: U muškaraca se Fertavid koristi u liječenju nedostatne spermatogeneze uslijed hipogonadotropnog hipogonadizma.
English: • have a tumour of the ovary, breast, uterus, testis or brain (pituitary gland or hypothalamus)
Croatian: • ako imate tumor jajnika, dojki, maternice, testisa ili mozga (hipofize ili hipotalamusa)
English: Concomitant use of Fertavid and clomifene citrate may enhance the follicular response.
Croatian: Istodobna primjena lijeka Fertavid i klomifen citrata može pojačati folikularni odgovor.
English: First, you should remove the flip-off cap of the vial.
Croatian: Najprije trebate skinuti poklopac s bočice.
English: The dosage should, therefore, be adjusted individually depending on the ovarian response.
Croatian: Stoga se doza mora prilagoditi individualno, ovisno o odgovoru jajnika.
English: Dosage in men
Croatian: Doziranje u muškaraca
English: • blood vessel problems (thrombophlebitis)
Croatian: • tegobe s krvnim žilama (tromboflebitis)
English: Transient liver function test abnormalities suggestive of hepatic dysfunction with or without morphologic changes on liver biopsy have also been reported in association with OHSS.
Croatian: Također su prijavljeni prolazni poremećeni nalazi pretraga jetrene funkcije, povezani s OHSS-om, koji ukazuju na poremećaj funkcije jetre, sa ili bez morfoloških promjena utvrđenih biopsijom jetre.
English: This requires ultrasound assessment of follicular development.
Croatian: Ovo zahtijeva procjenu razvoja folikula pomoću ultrazvuka.
English: Using the pen injector, injection of Fertavid can be carried out by the patient, provided that proper instructions are given by the physician.
Croatian: Koristeći brizgalicu, injekciju lijeka Fertavid može primijeniti sam bolesnik/bolesnica ako mu/joj je liječnik dao odgovarajuće upute.
English: It is unlikely that Fertavid is passed into breast milk.
Croatian: Nije vjerojatno da će Fertavid prijeći u majčino mlijeko.
English: It is available in packs of 1 cartridge.
Croatian: Dostupna je u staklenim ulošcima, u pakiranju od 1 uloška.
English: For patient convenience, Fertavid may be stored at or below 25ºC by the patient for a single period of not more than 3 months.
Croatian: Radi lakše uporabe, bolesnik može jednokratno čuvati Fertavid na temperaturi od ili ispod 25°C najdulje 3 mjeseca.
English: Fertavid cartridges are not designed to allow any other drug to be mixed in the cartridges.
Croatian: Fertavid ulošci izrađeni su tako da se u uložak ne može umiješati drugi lijek.
English: The separate instructions for using the pen must be followed carefully.
Croatian: Morate pažljivo slijediti zasebne upute za uporabu brizgalice.
English: Fertavid can be given either alone, or, to prevent premature luteinisation, in combination with a GnRH agonist or antagonist.
Croatian: Fertavid se može primjenjivati kao jedini lijek ili u kombinaciji s agonistom ili antagonistom GnRH-a radi sprječavanja prerane luteinizacije.
English: • have ever had a twisting of an ovary
Croatian: • ako ste ikad imali uvrtanje jajnika
English: Solution for injection 1 vial containing 0.5 ml 5 vials each containing 0.5 mL 10 vials each containing 0.5 mL
Croatian: Otopina za injekciju 1 bočica koja sadrži 0,5 ml 5 bočica; svaka sadrži 0,5 ml 10 bočica; svaka sadrži 0,5 ml
English: The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line.
Croatian: Otopina za injekciju sadrži djelatnu tvar folitropin beta, proizvedenu genetičkim inženjerstvom na staničnoj liniji jajnika kineskog hrčka (engl.
English: • have ovarian cysts or enlarged ovaries not caused by polycystic ovarian syndrome (PCOS)
Croatian: • ako imate ciste na jajniku ili povećane jajnike, koji nisu posljedica sindroma policističnih jajnika (PCOS)
English: Discard used needles immediately after injection.
Croatian: Upotrijebljene igle moraju se ukloniti odmah po injiciranju.
English: If you:
Croatian: U slučajevima:
English: In approximately 4% of the women treated with follitropin beta in clinical trials, signs and symptoms related to ovarian hyperstimulation syndrome (OHSS) have been reported (see section 4.4).
Croatian: Znakovi i simptomi povezani sa sindromom hiperstimulacije jajnika (OHSS) prijavljeni su u približno 4% žena liječenih folitropinom beta u kliničkim ispitivanjima (vidjeti dio 4.4).
English: Any remaining solution should be discarded.
Croatian: Preostalu otopinu morate baciti.
English: Adverse reactions related to this syndrome include pelvic pain and/or congestion, abdominal pain and/or distension, breast complaints and ovarian enlargement.
Croatian: Nuspojave povezane s tim sindromom uključuju bol i/ili kongestiju u zdjelici, abdominalnu bol i/ili distenziju, tegobe s dojkama i povećanje jajnika.
English: • have an underactive thyroid gland (hypothyroidism)
Croatian: • ako imate smanjenu aktivnost štitne žlijezde (hipotireozu)
English: The use of Fertavid during pregnancy is not indicated.
Croatian: Fertavid nije indiciran za primjenu u trudnoći.
English: Especially when switching from a syringe to the pen, small dose adjustments may be needed to prevent too high a dose being given.
Croatian: Možda će biti potrebne male prilagodbe doze kako bi se izbjegla primjena previsoke doze, osobito kad se sa štrcaljke prelazi na brizgalicu.
English: • Each cartridge contains the active substance follitropin beta, a hormone known as folliclestimulating hormone (FSH) in a strength of 833 IU/mL aqueous solution.
Croatian: • Jedan uložak sadrži djelatnu tvar folitropin beta, hormon poznat kao folikulostimulirajući hormon (FSH), u koncentraciji od 833 IU/ml vodene otopine.
English: Store at or below 25ºC (at room temperature) for a single period of not more than 3 months.
Croatian: Čuvati jednokratno na temperaturi od ili ispod 25°C (sobnoj temperaturi) najdulje 3 mjeseca.
English: Do not use the solution if it contains particles or is not clear.
Croatian: Otopinu ne smijete upotrijebiti ako sadrži čestice ili nije bistra.
English: Thromboembolic events, both in association with and separate from OHSS, have been reported following treatment with gonadotropins, including follitropin beta.
Croatian: Tromboembolijski događaji, kako oni povezani tako i oni nepovezani s OHSS-om, prijavljeni su nakon liječenja gonadotropinima, uključujući Fertavid.
English: The contents of a vial should be used immediately after piercing of the rubber stopper.
Croatian: Sadržaj bočice mora se upotrijebiti odmah nakon što se probije gumeni čep.
English: If follitropin beta would be excreted in human milk, it would be degraded in the gastrointestinal tract of the child. Follitropin beta may affect milk production.
Croatian: Kad bi se folitropin beta izlučivao u majčino mlijeko u ljudi, razgradio bi se u gastrointestinalnom traktu dojenčeta.
English: In women undergoing fertility treatment there may be a slightly higher chance of a miscarriage.
Croatian: U žena koje se liječe od neplodnosti nešto je veća vjerojatnost spontanog pobačaja.
English: Multiple Pregnancy or birth defects
Croatian: Višeplodna trudnoća ili prirođene mane
English: Your doctor will decide on your starting dose.
Croatian: Vaš liječnik će odrediti početnu dozu koja se može prilagođavati tijekom liječenja.
English: If necessary, the plunger may be squeezed further, to adjust the volume to be administered.
Croatian: Ako je potrebno, klip možete potisnuti još malo, kako biste odmjerili točnu količinu lijeka koju trebate primijeniti.
English: Thereafter, the dose may be adjusted individually, based upon ovarian response.
Croatian: Nakon toga se doza može individualno prilagoditi prema odgovoru jajnika.
English: Rates of pregnancy loss in women undergoing assisted reproduction techniques are higher than in the normal population.
Croatian: Stope spontanih pobačaja veće su u žena koje se podvrgavaju postupku potpomognute oplodnje nego u općoj populaciji.
English: Subcutaneous (SC) use
Croatian: Supkutana primjena (s.c.)
English: • have ever had ovarian hyperstimulation syndrome OHSS
Croatian: • ako ste ikad imali sindrom hiperstimulacije jajnika (OHSS)
English: • have past or current cysts in your ovary or ovaries.
Croatian: • ako ste imali ili imate ciste na jajniku ili jajnicima.
English: Store at or below 25°C for a single period of not more than 3 months.
Croatian: 2. Čuvati jednokratno na temperaturi od ili ispod 25°C najdulje 3 mjeseca.
English: Infertile women undergoing ART have an increased incidence of ectopic pregnancies.
Croatian: U neplodnih žena koje se podvrgavaju postupcima potpomognute oplodnje povećana je incidencija ektopičnih trudnoća.
English: 1,025 IU recombinant FSH activity/1.230 mL Net content 900 IU
Croatian: 1025 IU aktivnosti rekombinantnog FSH/1,230 ml Neto sadržaj 900 IU
English: Ovarian torsion is the twisting of an ovary.
Croatian: Torzija jajnika je uvrtanje jajnika.
English: In cartridges, designed to be used in conjunction with a pen injector.
Croatian: U ulošcima, namijenjenima za uporabu s brizgalicom za injiciranje.