FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of pregnancy loss by miscarriage or abortion is higher in patients undergoing stimulation of follicular growth for ovulation induction or ART than following natural conception.
Croatian: Incidencija gubitka trudnoće u vidu spontanog pobačaja ili prekida trudnoće veća je u pacijentica kod kojih se provodi stimulacija rasta folikula za poticanje ovulacije ili za metode medicinski potpomognute oplodnje u odnosu na prirodno začeće.
English: Ovarian Hyper-Stimulation Syndrome (OHSS)
Croatian: Sindrom hiperstimulacije jajnika (engl. ovarian hyperstimulation syndrome, OHSS)
English: In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and should be treated accordingly.
Croatian: Posebno treba provjeriti boluju li pacijentice od hipotireoze, smanjene aktivnosti kore nadbubrežne žlijezde ili hiperprolaktinemije te primijeniti odgovarajuće liječenje.
English: If your doctor cannot see a response after 5 weeks, that treatment cycle with Bemfola should be stopped.
Croatian: Ako Vaš liječnik ne primijeti željeni odgovor nakon 5 tjedana terapije, taj ciklus liječenja lijekom Bemfola treba prekinuti.
English: No direct comparison of follitropin alfa/LH versus human menopausal gonadotropin (hMG) has been performed.
Croatian: Nisu izravno uspoređene terapija folitropinom alfa/LH-om i terapija humanim menopauzalnim gonadotropinom (hMG).
English: Do not push the dosage knob in any further, at this point.
Croatian: Oprez: u ovom trenutku više nemojte pritiskati dugme za doziranje.
English: Bemfola 75 IU/0.125 mL pre-filled pen Bemfola 150 IU/0.25 mL pre-filled pen Bemfola 225 IU/0.375 mL pre-filled pen
Croatian: Bemfola 75 IU/0,125 ml napunjena brizgalica Bemfola 150 IU/0,25 ml napunjena brizgalica Bemfola 225 IU/0,375 ml napunjena brizgalica
English: Remove the inner needle cap.
Croatian: Uklonite unutarnji zatvarač igle.
English: This side effect is uncommon (may affect up to 1 in 100 people).
Croatian: Ta je nuspojava manje česta (može se javiti u do 1 na 100 osoba).
English: • If you use Bemfola at the same time as a “gonadotropin-releasing hormone” (GnRH) agonist or antagonist (these medicines reduce your sex hormone levels and stop you ovulating) you may need a higher dose of Bemfola to produce follicles.
Croatian: • Istodobna primjena lijeka Bemfola i agonista ili antagonista „hormona koji oslobađa gonadotropin“ (engl. gonadotropin-releasing hormone, GnRH) (lijekova koji smanjuju razine spolnih hormona i prekidaju ovulaciju) može zahtijevati povećanje doze lijeka Bemfola potrebne za stvaranje folikula.
English: • Each mL of the solution contains 600 IU (equivalent to 44 micrograms) follitropin alfa.
Croatian: • Jedan ml otopine sadrži 600 IU (što odgovara 44 mikrograma) folitropina alfa.
English: If your body responds too strongly, your treatment with Bemfola will be stopped and you will not be given any hCG (see section 2, OHSS).
Croatian: Ako dođe do prejakog odgovora Vašeg organizma, terapija lijekom Bemfola će se prekinuti i nećete primiti hCG (pogledajte odlomak o OHSS-u u dijelu 2.).
English: • The usual dose of Bemfola is 150 IU (0.25 mL) together with hCG.
Croatian: Muškarci • Uobičajena doza lijeka Bemfola je 150 IU (0,25 ml) zajedno s hCG-om.
English: • tumours of the hypothalamus or pituitary gland;
Croatian: • tumori hipotalamusa ili hipofize
English: 10 pre-filled pens 10 injection needles 10 alcohol swabs
Croatian: 10 napunjenih brizgalica 10 igala za injekcije
English: • Allergic reactions such as rash, red skin, hives, swelling of your face with difficulty breathing can sometimes be serious.
Croatian: • Alergijske reakcije kao što su osip, crvenilo kože, koprivnjača, oticanje lica i poteškoće pri disanju ponekad mogu biti ozbiljne.
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, koji je gotovo identičan prirodnom hormonu koji stvara
English: • Sacs of fluid within the ovaries (ovarian cysts)
Croatian: • vrećice s tekućinom u jajnicima (ciste na jajnicima)
English: Then Bemfola is started approximately two weeks after start of agonist treatment.
Croatian: Zatim se približno dva tjedna nakon početka liječenja agonistom počinje primjenjivati Bemfola.
English: You and your partner's fertility should be evaluated before the treatment is started by a doctor experienced in treating fertility disorders.
Croatian: Prije početka liječenja potrebno je provjeriti Vašu plodnost i plodnost Vašeg partnera kod liječnika iskusnog u liječenju problema s plodnošću.
English: Bemfola treatment seldom causes severe OHSS unless the medicine that is used for final follicular maturation (containing human chorionic gonadotropin, hCG) is administered.
Croatian: Terapija lijekom Bemfola rijetko uzrokuje težak OHSS, osim kada se daje lijek za poticanje konačnog sazrijevanja folikula (koji sadrži humani koriogonadotropin, hCG).
English: • malformations of sexual organs incompatible with pregnancy;
Croatian: • malformacije spolnih organa koje su nespojive s trudnoćom • fibroidni tumori maternice nespojivi s trudnoćom
English: Bemfola contains sodium
Croatian: Bemfola sadrži natrij
English: 5 pre-filled pens 5 injection needles 5 alcohol swabs
Croatian: 5 napunjenih brizgalica 5 igala za injekcije
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of fertility disorders.
Croatian: 4.2 Doziranje i način primjene Terapiju treba započeti pod nadzorom liječnika s iskustvom u liječenju poremećaja plodnosti.
English: In patients undergoing ART procedures the risk of multiple pregnancy is related mainly to the number of embryos replaced, their quality and the patient age.
Croatian: Rizik od višeplodne trudnoće nakon metoda medicinski potpomognute oplodnje prvenstveno je povezan s brojem prenesenih embrija, njihovom kvalitetom i dobi pacijentice.
English: The best time to have sex is on the day of the hCG injection and the day after.
Croatian: Preporučeno je imati spolni odnos na dan injekcije hCG-a i dan nakon toga.
English: Bemfola 300 IU/0.50 mL pre-filled pen Bemfola 450 IU/0.75 mL pre-filled pen
Croatian: Bemfola 300 IU/0,50 ml napunjena brizgalica Bemfola 450 IU/0,75 ml napunjena brizgalica
English: Poloxamer 188
Croatian: 4.8 Nuspojave
English: If an excessive response is obtained, treatment should be stopped and hCG withheld.
Croatian: U slučaju pretjeranog odgovora organizma potrebno je obustaviti terapiju i prestati primjenjivati hCG.
English: • The usual starting dose of Bemfola is 75 to 150 IU (0.12 to 0.25 mL) each day.
Croatian: • Uobičajena početna doza lijeka Bemfola je 75 - 150 IU (0,12 - 0,25 ml) svaki dan.
English: • together with another medicine called “human chorionic gonadotropin” (hCG) to help produce sperm in men that are infertile due to a low level of certain hormones.
Croatian: Chorionic Gonadotropin, hCG), s ciljem stvaranja sperme u muškaraca čija je neplodnost uzrokovana niskim razinama određenih hormona.
English: Other side effects in women
Croatian: Ostale nuspojave u žena
English: Down-regulation with a gonadotropin-releasing hormone (GnRH) agonist or antagonist is now commonly used in order to suppress the endogenous LH surge and to control tonic levels of LH.
Croatian: gonadotropin-releasing hormone, GnRH) kako bi se negativnom povratnom spregom suprimirao porast endogenog LH-a i kontrolirala tonička razina LH-a.
English: Luteal phase support may be considered since lack of substances with luteotrophic activity (LH/hCG) after ovulation may lead to premature failure of the corpus luteum.
Croatian: Može se razmotriti i podržavanje luteinske faze budući da manjak tvari s luteotropnim djelovanjem
English: Follitropin alfa is not indicated during breastfeeding.
Croatian: Folitropin alfa nije indiciran za vrijeme dojenja.
English: Weight gain
Croatian: povećanje tjelesne težine
English: Before opening and within its shelf life, the medicinal product may be removed from the refrigerator, and without being refrigerated again, may be stored for up to 3 months at or below 25°C.
Croatian: Prije otvaranja i unutar roka valjanosti, lijek se može izvaditi i čuvati izvan hladnjaka do 3 mjeseca na 25°C ili ispod 25°C, bez ponovnog odlaganja u hladnjak.
English: Bemfola 75 IU/0.125 mL (5.5 micrograms/0.125 mL) is not designed to allow the cartridge to be removed.
Croatian: Bemfola 75 IU/0,125 ml (5,5 mikrograma/0,125 ml) je izrađena tako da ne dopušta uklanjanje uloška.
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-a, primjena folitropina alfa istovremeno s hCG-om kroz najmanje
English: MARKETING AUTHORISATION HOLDER Gedeon Richter Plc.
Croatian: Gedeon Richter Plc.
English: Very common (may affect more than 1 in 10 people):
Croatian: Vrlo česte (mogu se javiti se u više od 1 na 10 osoba):
English: What Bemfola is used for
Croatian: Za što se Bemfola koristi
English: INFORMATION IN BRAILLE Bemfola 75 IU/0.125 mL
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Bemfola 75 IU/0,125 ml
English: Posology
Croatian: SADRŽAJ
English: A single injection of 250 micrograms r-hCG or 5,000 IU up to 10,000 IU hCG is administered 24-48 hours after the last follitropin alfa injection to induce final follicular maturation.
Croatian: Jedna injekcija od 250 mikrograma rekombinantnog r-hCG-a ili 5000 IU do najviše 10 000 IU hCG-a daje se 24 do 48 sati nakon zadnje injekcije folitropina alfa kako bi se potaknulo konačno sazrijevanje folikula.
English: Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting, diarrhoea
Croatian: bol u abdomenu, distenzija abdomena, nelagoda u abdomenu, mučnina, povraćanje, proljev
English: Bemfola 75 IU/0.125 mL solution for injection in pre-filled pen Bemfola 150 IU/0.25 mL solution for injection in pre-filled pen Bemfola 225 IU/0.375 mL solution for injection in pre-filled pen
Croatian: Bemfola 75 IU/0,125 ml otopina za injekciju u napunjenoj brizgalici Bemfola 150 IU/0,25 ml otopina za injekciju u napunjenoj brizgalici Bemfola 225 IU/0,375 ml otopina za injekciju u napunjenoj brizgalici
English: • primary ovarian failure;
Croatian: • primarno zatajenje rada jajnika
English: Bemfola usually does not work if you have this problem.
Croatian: U ovim slučajevima lijek Bemfola obično nije učinkovit.
English: INFORMATION IN BRAILLE Bemfola 225 IU/0.375 mL
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Bemfola 225 IU/0,375 ml
English: Thromboembolism (both in association with and separate from OHSS.
Croatian: tromboembolija (i povezana ili nepovezana s OHSS-om)
English: • Anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomiphene citrate.
Croatian: • Anovulacija (uključujući sindrom policističnih jajnika [engl. polycystic ovarian syndrome, PCOS]) u žena koje ne reagiraju na terapiju klomifencitratom.
English: Bemfola 225 IU/0.375 mL (16.5 micrograms/0.375 mL) is not designed to allow the cartridge to be removed.
Croatian: Bemfola 225 IU/0,375 ml (16,5 mikrograma/0,375 ml) je izrađena tako da ne dopušta uklanjanje uloška.
English: Bemfola 150 IU/0.25 mL (11 micrograms/0.25 mL) is not designed to allow the cartridge to be removed.
Croatian: Bemfola 150 IU/0,25 ml (11 mikrograma/0,25 ml) je izrađena tako da ne dopušta uklanjanje uloška.
English: • ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome;
Croatian: • povećani jajnici ili ciste na jajnicima koje nisu uzrokovane sindromom policističnih jajnika
English: • Bemfola 150 IU/0.25 mL: Each cartridge contains 150 IU (equivalent to 11 micrograms) follitropin alfa in 0.25 mL solution.
Croatian: • Bemfola 150 IU/0,25 ml: Jedan uložak sadrži 150 IU (što odgovara 11 mikrograma) folitropina alfa u 0,25 ml otopine.
English: • Bemfola 225 IU/0.375 mL: Each cartridge contains 225 IU (equivalent to 16.5 micrograms) follitropin alfa in 0.375 mL solution.
Croatian: • Bemfola 225 IU/0,375 ml: Jedan uložak sadrži 225 IU (što odgovara 16,5 mikrograma) folitropina alfa u 0,375 ml otopine.
English: Each pre-filled pen delivers 150 IU follitropin alfa, equivalent to 11 micrograms per 0.25 mL.
Croatian: Jedna napunjena brizgalica isporučuje 150 IU folitropin alfa, što odgovara 11 mikrograma u 0,25 ml.
English: Pregnancy and breast-feeding Do not use Bemfola if you are pregnant or breast-feeding.
Croatian: Nemojte primjenjivati lijek Bemfola ako ste trudni ili dojite.
English: How to use the Bemfola pre-filled pen
Croatian: Kako koristiti napunjenu brizgalicu s lijekom Bemfola
English: • The usual starting dose of Bemfola is 150 to 225 IU (0.25 to 0.37 mL) each day, from day 2 or 3 of your treatment cycle.
Croatian: • Uobičajena početna doza lijeka Bemfola je 150 - 225 IU (0,25 - 0,37 ml) svaki dan, od 2. ili
English: This side effect is common (may affect up to 1 in 10 people).
Croatian: Ta je nuspojava česta (može se javiti u do 1 na 10 osoba).
English: • Bemfola 75 IU/0.125 mL: Each cartridge contains 75 IU (equivalent to 5.5 micrograms) follitropin alfa in 0.125 mL solution.
Croatian: • Bemfola 75 IU/0,125 ml: Jedan uložak sadrži 75 IU (što odgovara 5,5 mikrograma) folitropina alfa u 0,125 ml otopine.
English: Getting your pre-filled pen ready for injection
Croatian: Priprema napunjene brizgalice za injekciju
English: You should also hear a click, and some liquid will splash out (this is normal).The pen is now ready to set the dose.
Croatian: Trebali biste čuti i „klik“, a iz igle će izaći malo tekućine
English: INFORMATION IN BRAILLE Bemfola 300 IU/0.5 mL
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Bemfola 300 IU/0,5 mL
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Gedeon Richter Plc.
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Gedeon Richter Plc.
English: In ART, follitropin alfa at a lower total dose and shorter treatment period than urinary FSH, resulted in a higher number of oocytes retrieved when compared to urinary FSH.
Croatian: Kod medicinski potpomognute oplodnje, folitropin alfa je pri manjoj ukupnoj dozi i uz kraće trajanje terapije nego kod urinarnog FSH rezultirao većim brojem dobivenih oocita u usporedbi s urinarnim FSH-om.
English: Each pre-filled pen delivers 225 IU follitropin alfa, equivalent to 16.5 micrograms per 0.375 mL.
Croatian: Jedna napunjena brizgalica isporučuje 225 IU folitropin alfa, što odgovara 16,5 mikrograma u 0,375 ml.
English: Each pre-filled pen delivers 450 IU follitropin alfa, equivalent to 33 micrograms per 0.75 mL.
Croatian: Jedna napunjena brizgalica isporučuje 450 IU folitropin alfa, što odgovara 33 mikrograma u 0,75 ml.
English: Bemfola 450 IU/0.75 mL (33 micrograms/0.75 mL) is not designed to allow the cartridge to be removed.
Croatian: Bemfola 450 IU/0,75 ml (33 mikrograma/0,75 ml) je izrađena tako da ne dopušta uklanjanje uloška.
English: For the following cycle, your doctor will give you a lower dose of Bemfola than before.
Croatian: Za sljedeći ciklus liječnik će Vam propisati lijek Bemfola u manjoj dozi nego u prethodnom ciklusu.
English: Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Phosphoric acid
Croatian: 6.1 Popis pomoćnih tvari poloksamer 188 saharoza metionin natrijev hidrogenfosfat dihidrat natrijev dihidrogenfosfat dihidrat fosfatna kiselina voda za injekcije
English: • When you get the desired response, you will be given a single injection of 250 micrograms of “recombinant hCG” (r-hCG, an hCG made in a laboratory by a special DNA technique), or 5,000 to 10,000 IU of hCG, 24 to 48 hours after your last Bemfola injection.
Croatian: • Kada se postigne željeni odgovor, daje se jedna injekcija od 250 mikrograma „rekombinantnog hCG-a“ (r-hCG, hCG dobiven u laboratoriju posebnom DNK tehnikom) ili 5 000 IU - 10 000 IU hCG-a 24 - 48 sati nakon posljednje injekcije lijeka Bemfola.
English: Each prefilled pen delivers 75 IU (equivalent to 5.5 micrograms) in 0.125 mL.
Croatian: Jedna napunjena brizgalica osigurava primjenu 75 IU (što odgovara 5,5 mikrograma) u 0,125 ml.
English: INFORMATION IN BRAILLE Bemfola 450 IU/0.75 mL
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Bemfola 450 IU/0,75 mL
English: Women undergoing ovarian stimulation for multiple follicular development prior to in vitro fertilisation or other assisted reproductive technologies A commonly used regimen for superovulation involves the administration of 150-225 IU of follitropin alfa daily commencing on days 2 or 3 of the cycle.
Croatian: Uobičajeni režim terapije za superovulaciju uključuje primjenu 150-225 IU folitropina alfa dnevno, počevši 2. ili 3. dana ciklusa.
English: • Bemfola 450 IU/0.75 mL: Each cartridge contains 450 IU (equivalent to 33 micrograms) follitropin alfa in 0.75 mL solution.
Croatian: • Bemfola 450 IU/0,75 ml: Jedan uložak sadrži 450 IU (što odgovara 33 mikrograma) folitropina alfa u 0,75 ml otopine.
English: Reproductive system and breast disorders Common:
Croatian: Poremećaji reproduktivnog sustava i dojki Vrlo često:
English: Each prefilled pen delivers 300 IU (equivalent to 22 micrograms) in 0.5 mL.
Croatian: Jedna napunjena brizgalica osigurava primjenu 300 IU (što odgovara 22 mikrograma) u 0,5 ml.
English: How to store Bemfola
Croatian: Kako primjenjivati lijek Bemfola
English: Each pre-filled pen delivers 300 IU follitropin alfa, equivalent to 22 micrograms per 0.5 mL.
Croatian: Jedna napunjena brizgalica isporučuje 300 IU folitropin alfa, što odgovara 22 mikrograma u 0,5 ml.
English: Each prefilled pen delivers 150 IU (equivalent to 11 micrograms) in 0.25 mL.
Croatian: Jedna napunjena brizgalica osigurava primjenu 150 IU (što odgovara 11 mikrograma) u 0,25 ml.
English: • When you get the desired response, you will be given a single injection of 250 micrograms of “recombinant hCG” (r-hCG, an hCG made in a laboratory by a special DNA technique), or 5,000 to 10,000 IU of hCG, 24 to 48 hours after your last injections of Bemfola and lutropin alfa.
Croatian: • Kada se postigne željeni odgovor, daje se jedna injekcija od 250 mikrograma „rekombinantnog hCG-a“ (r-hCG, hCG dobiven u laboratoriju posebnom DNK tehnikom) ili 5 000 IU - 10 000 IU hCG-a 24 - 48 sati nakon posljednje injekcije lijeka Bemfola i lutropina alfa.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.125 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 0,125 ml
English: Miscarriage
Croatian: Doziranje
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Croatian: Naziv i adresa proizvođača biološke djelatne tvari
English: • Bemfola 300 IU/0.50 mL: Each cartridge contains 300 IU (equivalent to 22 micrograms) follitropin alfa in 0.50 mL solution.
Croatian: • Bemfola 300 IU/0,50 ml: Jedan uložak sadrži 300 IU (što odgovara 22 mikrograma) folitropina alfa u 0,50 ml otopine.
English: Marketing Authorisation Holder and Manufacturer Gedeon Richter Plc.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Gedeon Richter Plc.
English: INFORMATION IN BRAILLE Bemfola 150 IU/0.25 mL
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Bemfola 150 IU/0,25 ml
English: Each prefilled pen delivers 225 IU (equivalent to 16.5 micrograms) in 0.375 mL.
Croatian: Jedna napunjena brizgalica osigurava primjenu 225 IU (što odgovara 16,5 mikrograma) u 0,375 ml.
English: Bemfola 300 IU/0.50 mL (22 micrograms/0.5 mL) is not designed to allow the cartridge to be removed.
Croatian: Bemfola 300 IU/0,50 ml (22 mikrograma/0,5 ml) je izrađena tako da ne dopušta uklanjanje uloška.
English: For the following cycle, your doctor will give you a higher starting dose of Bemfola than before.
Croatian: Za sljedeći ciklus liječnik će Vam propisati lijek Bemfola u većoj početnoj dozi nego u prethodnom ciklusu.
English: Each prefilled pen delivers 450 IU (equivalent to 33 micrograms) in 0.75 mL.
Croatian: Jedna napunjena brizgalica osigurava primjenu 450 IU (što odgovara 33 mikrograma) u 0,75 ml.
English: When an optimal response is obtained, a single injection of 250 micrograms of recombinant human chorionic gonadotropin alfa (r-hCG) or 5,000 IU up to 10,000 IU hCG should be administered 24-48 hours after the last follitropin alfa injection.
Croatian: Kada se postigne optimalan odgovor, potrebno je dati jednu injekciju od 250 mikrograma rekombinantnog humanog koriogonadotropina alfa (r-hCG) ili 5000 IU - 10 000 IU humanog korionskog gonadotropina 24 - 48 sati nakon zadnje injekcije folitropina alfa.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.375 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 0,375 ml
English: • The usual starting dose of Bemfola is 75 to 150 IU (0.12 to 0.25 mL) together with 75 IU (0.12 mL) of lutropin alfa.
Croatian: • Uobičajena početna doza lijeka Bemfola je 75 - 150 IU (0,12 - 0,25 ml) zajedno sa 75 IU
English: Exacerbation or aggravation of asthma Gastrointestinal disorders Common:
Croatian: egzacerbacija ili pogoršanje astme
English: Exacerbation or aggravation of asthma Skin and subcutaneous tissue disorders Common:
Croatian: Poremećaji kože i potkožnog tkiva Često:
English: Bemfola 300 IU/0.50 mL solution for injection in pre-filled pen Bemfola 450 IU/0.75 mL solution for injection in pre-filled pen follitropin alfa
Croatian: Bemfola 300 IU/0,50 ml otopina za injekciju u napunjenoj brizgalici Bemfola 450 IU/0,75 ml otopina za injekciju u napunjenoj brizgalici
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 225 IU/0.375 mL injection follitropin alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Bemfola 225 IU/0,375 ml injekcija folitropin alfa s.c.
English: When an optimal response is obtained, a single injection of 250 micrograms r-hCG or 5,000 IU up to 10,000 IU hCG should be administered 24-48 hours after the last follitropin alfa and lutropin alfa injections.
Croatian: Kada se postigne optimalan odgovor na terapiju, treba dati jednu injekciju s 250 mikrograma r-hCG-a ili 5000 - 10 000 IU hCG-a 24 - 48 sati nakon zadnje injekcije folitropina alfa i lutropina alfa.
English: NAME OF THE MEDICINAL PRODUCT Bemfola 75 IU/0.125 mL solution for injection in pre-filled pen
Croatian: NAZIV LIJEKA Bemfola 75 IU/0,125 ml otopina za injekciju u napunjenoj brizgalici
English: • gynaecological haemorrhages of unknown aetiology;
Croatian: • ginekološka krvarenja nepoznate etiologije • karcinom jajnika, maternice ili dojke.
English: Each cartridge contains 0.375 mL solution for injection.
Croatian: Svaki uložak sadrži 0,375 ml otopine za injekcije.
English: Multiple pregnancy
Croatian: Višeplodne trudnoće
English: Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting,
Croatian: bol u abdomenu, distenzija abdomena, nelagoda u abdomenu, mučnina,
English: Women
Croatian: DJECE
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 75 IU/0.125 mL injection follitropin alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Bemfola 75 IU/0,125 ml injekcija folitropin alfa s.c.
English: Nevertheless one could expect Ovarian HyperStimulation Syndrome (OHSS) to occur, which is described in section 4.
Croatian: Učinci predoziranja lijekom Bemfola nisu poznati, ali može se očekivati pojava sindroma hiperstimulacije jajnika (OHSS), koji je opisan u dijelu 4. No, OHSS će se pojaviti samo ako se primjenjuje i hCG (pogledajte odlomak o OHSS-u u dijelu 2.).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 450 IU/0.75 mL injection follitropin alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Bemfola 450 IU/0,75 ml injekcija folitropin alfa s.c.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 300 IU/0.5 mL injection follitropin alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Bemfola 300 IU/0,5 ml injekcija folitropin alfa s.c.
English: • Feeling sick, vomiting, diarrhoea, abdominal cramps and bloating
Croatian: • mučnina, povraćanje, proljev, grčevi u trbuhu i nadutost
English: NAME OF THE MEDICINAL PRODUCT Bemfola 225 IU/0.375 mL solution for injection in pre-filled pen
Croatian: NAZIV LIJEKA B[MI2]emfola 225 IU/0,375 ml otopina za injekciju u napunjenoj brizgalici