FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and/or estrogen secretion.
Slovenian: Zdravljenje mora biti prilagojeno odzivu posamezne bolnice in se oceni z merjenjem velikosti folikla z ultrazvokom in/ali merjenjem izločenega estrogena.
English: Serious side effects in women
Slovenian: Resni neželeni učinki pri ženskah
English: Treatment should recommence in the next cycle at a dose of FSH lower than that of the previous cycle.
Slovenian: Ponovno zdravljenje se mora v naslednjem ciklusu začeti z manjšimi odmerki FSH kot v predhodnem ciklusu.
English: If your doctor cannot see a desired response after 4 weeks, that treatment cycle with Bemfola should be stopped.
Slovenian: Če vaš zdravnik ne more doseči ustreznega odziva po štirih tednih zdravljenja, je treba ciklus zdravljenja z zdravilom Bemfola opustiti.
English: Lightly pinch the skin of the injection area.
Slovenian: Na mestu injiciranja kožo rahlo stisnite v gubo.
English: Respiratory, thoracic and mediastinal disorders Very rare:
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo redki:
English: In clinical trials, an increase of the ovarian sensitivity to follitropin alfa was shown when administered with lutropin alfa.
Slovenian: V kliničnih preskušanjih se je pokazalo, da se poveča občutljivost jajčnikov za folitropin alfa, kadar se uporablja skupaj z lutropinom alfa.
English: • The other ingredients are poloxamer 188, sucrose, methionine, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, phosphoric acid and water for injections.
Slovenian: - Druge sestavine zdravila so poloksamer 188, saharoza, metionin, dinatrijev fosfat dihidrat, natrijev dihidrogenfosfat dihidrat, fosforjeva kislina in voda za injekcije.
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).
Slovenian: To zdravilo vsebuje učinkovino folitropin alfa, ki je skoraj enaka naravnemu hormonu, imenovanemu
English: with unexplained vaginal bleeding.
Slovenian: neznanega izvora; z ginekološkimi krvavitvami nepojasnjenega vzroka;
English: For example, following two weeks of treatment with an agonist, 150-225 IU follitropin alfa are administered for the first 7 days.
Slovenian: Na primer, po dvotedenskem zdravljenju z agonistom se prvih 7 dni daje 150-225 i.e. folitropina alfa.
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.
Slovenian: Pri ART je folitropin alfa pri nižjem skupnem odmerku in krajšem obdobju zdravljenja glede na urinarni FSH povzročil večje število pridobljenih oocitov kot urinarni FSH.
English: You and your partner's fertility should be evaluated before the treatment is started by a doctor experienced in treating fertility disorders.
Slovenian: Pred pričetkom mora vašo plodnost in plodnost vašega partnerja oceniti zdravnik z izkušnjami pri zdravljenju motenj plodnosti.
English: • Bemfola is supplied in packs with 1, 5 or 10 pre-filled pens, 1, 5 or 10 disposable needles and 1,
Slovenian: • Zdravilo Bemfola je na voljo je v pakiranjih z 1, 5 ali 10 napolnjenim injekcijskimi peresniki, 1, 5 ali 10 injekcijskih igel za enkratno uporabo in 1, 5 ali 10 alkoholna zloženca.
English: Your doctor will have told you how many IU to inject each day.
Slovenian: koliko i.e. si morate vsak dan injicirati.
English: Pregnancy and breast-feeding Do not use Bemfola if you are pregnant or breast-feeding.
Slovenian: Ne uporabljajte zdravila Bemfola, če ste noseči ali če dojite.
English: with cancer in your ovaries, womb or breasts.
Slovenian: rak na jajčniku, maternici ali dojkah.
English: Clean the injection site with the alcohol swab using a circular motion.
Slovenian: Mesto injiciranja očistite s krožnimi gibi z alkoholnim zložencem.
English: Women with anovulation resulting from severe LH and FSH deficiency In LH and FSH deficient women (hypogonadotropic hypogonadism), the objective of follitropin alfa therapy in association with lutropin alfa is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of human chorionic gonadotropin (hCG).
Slovenian: Pri ženskah s pomanjkanjem LH in FSH (hipogonadotropni hipogonadizem) je cilj zdravljenja s folitropinom alfa skupaj z lutropinom alfa razvoj enega samega zrelega Graafovega folikla, iz katerega se bo sprostilo jajčece po dajanju humanega horionskega gonadotropina (hCG).
English: The dose recommendations given for follitropin alfa are those in use for urinary FSH.
Slovenian: Priporočeni odmerek folitropina alfa je enak kot za urinarni FSH.
English: One-eighth of the follitropin alfa dose is excreted in the urine.
Slovenian: Ena osmina odmerka folitropin alfa se izloči z urinom.
English: Monitoring of stimulation cycles by ultrasound scans as well as estradiol measurements are recommended to early identify risk factors.
Slovenian: Za zgodnje odkrivanje dejavnikov tveganja se priporoča nadzor stimulacije ciklusov z ultrazvokom in merjenjem estradiola.
English: Posology
Slovenian: VSEBINA
English: If an excessive response is obtained, treatment should be stopped and hCG withheld (see section 4.4).
Slovenian: Če pride do pretiranega odziva, se mora zdravljenje prekiniti in opustiti dajanje hCG (glejte poglavje 4.4).
English: Do not twist it on. You will hear a click when it is securely fixed.
Slovenian: Ko bo varno pritrjena, boste slišali klik.
English: Poloxamer 188, sucrose, methionine, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, phosphoric acid and water for injections.
Slovenian: SEZNAM POMOŽNIH SNOVI poloksamer 188, saharoza, metionin, dinatrijev fosfat dihidrat, natrijev dihidrogenfosfat dihidrat, fosforjeva kislina in voda za injekcije.
English: Paediatric population There is no relevant use of follitropin alfa in the paediatric population.
Slovenian: Pediatrična populacija Folitropin alfa ni primeren za uporabo pri pediatričnih bolnikih.
English: Severe OHSS is uncommon (see section 4.4).
Slovenian: Hud OHSS je občasen (glejte poglavje 4.4).
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.
Slovenian: Po intravenski uporabi se folitropin alfa porazdeli v zunajcelični prostor z začetnim razpolovnim časom približno dve uri in izloči iz telesa s končnim razpolovnim časom približno en dan. Volumen porazdelitve v stanju dinamičnega ravnovesja je 10 l, celokupni očistek je 0,6 l/h.
English: • If you use Bemfola with other medicines which help ovulation (such as hCG or clomiphene citrate), this may increase the response of your follicles.
Slovenian: • Sočasna uporaba zdravila Bemfola z drugimi zdravili za stimuliranje ovulacije (kot sta hCG ali klomifen citrat) lahko potencira folikularni odziv.
English: The most commonly reported adverse reactions are headache, ovarian cysts and local injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection).
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali, so glavobol, ciste jajčnikov ali lokalne reakcije na mestu injiciranja (npr. bolečina, eritem, hematom, oteklina in/ali razdraženost na mestu injiciranja).
English: 5 or 10 alcohol swabs.
Slovenian: 5 alkoholnih zložencev
English: This side effect is uncommon (may affect up to 1 in 100 people).
Slovenian: Ta neželeni učinek je občasen (pojavi se lahko pri največ 1 bolniku od 100).
English: 5 pre-filled pens 5 injection needles 5 alcohol swabs
Slovenian: 5 napolnjenih injekcijskih peresnikov 5 injekcijskih igel
English: The medicinal product must be discarded if it has not been used after 3 months.
Slovenian: Če se zdravilo po treh mesecih ne uporabi, ga je treba zavreči.
English: Caution: Do not push the dosage knob, while inserting the needle.
Slovenian: Pozor: Med vbodom igle ne potiskajte gumba za nastavitev odmerka.
English: • The active substance is follitropin alfa.
Slovenian: - Učinkovina je folitropin alfa.
English: For the following cycle, your doctor will give you a lower dose of Bemfola than before.
Slovenian: Za naslednji ciklus vam bo vaš zdravnik predpisal manjši odmerek zdravila Bemfola kot v predhodnem ciklusu.
English: Multiple pregnancy
Slovenian: Večplodna nosečnost
English: Follitropin alfa is not indicated during breastfeeding.
Slovenian: Folitropin alfa ni indiciran v obdobju dojenja.
English: No other clinically significant medicinal product interaction has been reported during follitropin alfa therapy.
Slovenian: Med zdravljenjem s folitropinom alfa niso poročali o drugih klinično pomembnih interakcijah z medicinskimi produkti.
English: Hold the pen by its sides and attach the needle by clicking it into place.
Slovenian: Injekcijski peresnik držite ob straneh in s klikom namestite iglo.
English: Discard used pen and needle immediately after injection.
Slovenian: Uporabljena injekcijski peresnik in injekcijsko iglo zavrzite takoj po injiciranju.
English: Replace the outer needle cap onto the needle carefully.
Slovenian: Na iglo previdno ponovno namestite zunanji pokrovček igle.
English: Thromboembolism (both in association with and separate from OHSS) Respiratory, thoracic and mediastinal disorders Very rare:
Slovenian: trombembolizem, (tako v povezavi z in ločeno od OHSS) Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo redki:
English: One needle and one alcohol swab to be used with the pen for administration.
Slovenian: Ena injekcijska igla in en alkoholni zloženec se uporabita z injekcijskim peresnikom za dajanje zdravila.
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)
Slovenian: Preglednica 1: Rezultati preskušanja GF 8407 (randomizirano preskušanje z vzporednima skupinama,
English: PHARMACEUTICAL FORM Solution for injection (injection).
Slovenian: FARMACEVTSKA OBLIKA Raztopina za injiciranje (injekcija) Bistra, brezbarvna raztopina.
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).
Slovenian: • Spodbujanje razvoja več foliklov pri ženskah, pri katerih je treba izzvati superovulacijo v postopkih asistirane reprodukcije (ART- assisted reproductive technologies), kot so oploditev in vitro (IVF-in vitro fertilisation), prenos gamete v jajcevod (GIFT - gamete intra-fallopian transfer) in prenos zigote v jajcevod (ZIFT-zygote intra-fallopian transfer).
English: What Bemfola is and what it is used for
Slovenian: Kaj je zdravilo Bemfola in za kaj ga uporabljamo Kaj je zdravilo Bemfola
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.
Slovenian: Tveganje večplodne nosečnosti po uporabi postopkov asistirane reprodukcije je v glavnem povezano s številom vsajenih embrijev, njihovo kakovostjo in starostjo bolnice.
English: MARKETING AUTHORISATION HOLDER Gedeon Richter Plc.
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Gedeon Richter Plc.
English: Reproductive system and breast disorders Common:
Slovenian: Motnje reprodukcije in dojk Pogosti:
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.
Slovenian: Neklinični podatki na osnovi običajnih študij toksičnosti, pri enkratnih in ponavljajočih se odmerkih, in genotoksičnosti ne kažejo posebnega tveganja za človeka, poleg že omenjenega v drugih poglavjih tega povzetka glavnih značilnosti zdravila.
English: • hypersensitivity to the active substance or to any of the excipients listed in section 6.1;
Slovenian: 4.3 Kontraindikacije preobčutljivost za učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1; tumorji hipotalamusa ali hipofize;
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.
Slovenian: Obsega izrazito povečanje jajčnikov, visoko raven spolnih steroidnih hormonov in povečano prepustnost žil, kar lahko pripelje do nabiranja tekočine v trebušni votlini,
English: The effects of taking too much Bemfola are unknown.
Slovenian: Če ste uporabili večji odmerek zdravila Bemfola, kot bi smeli Učinki jemanja prevelike količine zdravila Bemfola niso znani.
English: Ectopic pregnancy
Slovenian: Zunajmaternična nosečnost
English: 10 pre-filled pens 10 injection needles 10 alcohol swabs
Slovenian: 10 napolnjenih injekcijskih peresnikov 10 injekcijskih igel
English: Very common (may affect more than 1 in 10 people):
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 bolniku od 10):
English: • to help develop several follicles (each containing an egg) in women undergoing assisted reproductive technology procedures (procedures that may help you to become pregnant) such as “in vitro fertilisation”, “gamete intra-fallopian transfer” or “zygote intra-fallopian transfer”.
Slovenian: • za pomoč pri razvoju več foliklov (od katerih vsak vsebuje jajčece) pri ženskah v postopkih asistirane reprodukcije (postopku, ki lahko pomaga pri zanositvi), kot so „oploditev in vitro“, „prenos gamete v jajcevod“ ali „prenos zigote v jajcevod“.
English: Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: For the following cycle, your doctor will give you a higher starting dose of Bemfola than before.
Slovenian: Za naslednji ciklus vam bo vaš zdravnik predpisal zdravljenje z večjim začetnim odmerkom zdravila Bemfola kot v predhodnem ciklusu.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED PEN LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: • The usual starting dose of Bemfola is 75 to 150 IU (0.12 to 0.25 mL) each day.
Slovenian: • Običajni začetni odmerek zdravila Bemfola je 75 do 150 i.e. (0,12 do 0,25 ml) skupaj s 75 i.e.
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.
Slovenian: Folitropin alfa je močna gonadotropna učinkovina, ki lahko povzroči blage do hude neželene reakcije,
English: • ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome;
Slovenian: • povečanje jajčnika ali ciste jajčnika, katere vzrok ni sindrom policističnega jajčnika;
English: INFORMATION IN BRAILLE Bemfola 75 IU/0.125 mL
Slovenian: PODATKI V BRAILLOVI PISAVI Bemfola 75 i.e./0,125 ml
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Gedeon Richter Plc.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Gedeon Richter Plc.
English: • Follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotropin (hCG) therapy.
Slovenian: indiciran za stimulacijo spermatogeneze pri moških, ki imajo prirojen ali pridobljen hipogonadotropni hipogonadizem.
English: What Bemfola contains
Slovenian: Kaj vsebuje zdravilo Bemfola
English: Adherence to the recommended follitropin alfa dose and regimen of administration, and careful monitoring of therapy will minimise the incidence of such events.
Slovenian: Pogostnost takih dogodkov se zmanjša na najmanjši možni obseg ob upoštevanju priporočenega odmerka in režima dajanja folitropina alfa ter ob skrbnem nadzorovanju zdravljenja.
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.
Slovenian: Podpora lutealne faze je morda potrebna, ker lahko pomanjkanje snovi z luteotropnim učinkom
English: Very common (may affect more than 1 in 10 people): • Local reactions at the injection site, such as pain, redness, bruising, swelling and/or irritation
Slovenian: Zelo redki (pojavijo se lahko pri največ 1 bolniku od 10.000): • pojavijo se lahko alergijske reakcije, kot so osip, pordela koža, koprivnica, oteklost obraza s težavami dihanja.
English: Pack sizes of 1, 5 and 10 pre-filled pens including one disposable needle and alcohol swab per pen.
Slovenian: V pakiranju je 1, 5 ali 10 napolnjenih injekcijskih peresnikov, ena injekcijska igla za enkratno uporabo in en alkoholni zloženec na injekcijski peresnik.
English: • Bemfola 150 IU/0.25 mL: Each cartridge contains 150 IU (equivalent to 11 micrograms) follitropin alfa in 0.25 mL solution.
Slovenian: Bemfola 150 i.e./0,25 ml: En vložek vsebuje 150 i.e. (kar ustreza 11 mikrogramom) folitropina alfa v 0,25 ml raztopine.
English: INFORMATION IN BRAILLE Bemfola 300 IU/0.5 mL
Slovenian: PODATKI V BRAILLOVI PISAVI Bemfola 300 i.e./0,5 ml
English: Bemfola 75 IU/0.125 mL (5.5 micrograms/0.125 mL) is not designed to allow the cartridge to be removed.
Slovenian: Zdravilo Bemfola 75 i.e./0,125 ml (5,5 mikrograma/0,125 ml) je oblikovano tako, da ne dopušča odstranitve vložka.
English: In clinical trials comparing r-hFSH (follitropin alfa) and urinary FSH in ART (see table 1 below) and in ovulation induction, follitropin alfa was more potent than urinary FSH in terms of a lower total dose and a shorter treatment period needed to trigger follicular maturation.
Slovenian: V kliničnih preskušanjih so primerjali r-hFSH (folitropin alfa) in urinarni FSH pri ART (glejte preglednico spodaj) ter pri indukciji ovulacije.
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.
Slovenian: Ena sama 250-mikrogramska injekcija r-hCG ali 5.000 i.e. do 10.000 i.e. hCG se injicira 24 do 48 ur po zadnji injekciji folitropina alfa za sprožitev končnega zorenja foliklov.
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
Slovenian: Bemfola 75 i.e./0,125 ml napolnjen injekcijski peresnik Bemfola 150 i.e./0,25 ml napolnjen injekcijski peresnik Bemfola 225 i.e./0,375 ml napolnjen injekcijski peresnik
English: INFORMATION IN BRAILLE Bemfola 225 IU/0.375 mL
Slovenian: PODATKI V BRAILLOVI PISAVI Bemfola 225 i.e./0,375 ml
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
Slovenian: Bemfola 75 i.e./0,125 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Bemfola 150 i.e./0,25 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Bemfola 225 i.e./0,375 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
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.
Slovenian: Ko je dosežen optimalen odziv, je treba dati eno samo 250-mikrogramsko injekcijo rekombinantnega humanega horionskega gonadotropina alfa (r-hCG) ali 5.000 i.e. do 10.000 i.e. hCG 24 do 48 ur po zadnji injekciji folitropina alfa.
English: Hold the pen so that the needle is pointing upright.
Slovenian: Injekcijski peresnik držite tako, da je igla obrnjena navzgor.
English: Acne
Slovenian: akne
English: Throw away the packaging box, inner needle cap, peel tab, alcohol swab and the instructions for use in the normal household waste.
Slovenian: alkoholni zloženec in navodila za uporabo zavrzite v navadne gospodinjske odpadke.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: The patient is recommended to have coitus on the day of, and on the day following, hCG administration.
Slovenian: Bolnici se priporoča spolni odnos na isti dan, ko je prejela hCG, in naslednji dan.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.125 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 0,125 ml
English: Bemfola 225 IU/0.375 mL (16.5 micrograms/0.375 mL) is not designed to allow the cartridge to be removed.
Slovenian: Zdravilo Bemfola 225 i.e./0,375 ml (16,5 mikrograma/0,375 ml) je oblikovano tako, da ne dopušča odstranitve vložka.
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.
Slovenian: • Običajni začetni odmerek zdravila Bemfola je 75 do 150 i.e. (0,12 do 0,25 ml) vsak dan. • Vaš odmerek zdravila Bemfola se lahko poveča vsakih 7 ali 14 dni za 37,5 do 75 i.e., dokler ne boste dosegli želenega odziva ali dokler vam zdravnik ne pove, da lahko prenehate, glejte spodaj.
English: Thromboembolism (both in association with and separate from OHSS.
Slovenian: trombembolizem tako v povezavi z in ločeno od OHSS
English: Within its shelf life, the unopened pen may be stored at or below 25°C for up to 3 months without being refrigerated again and must be discarded if it has not been used after 3 months.
Slovenian: V času roka uporabnosti se lahko neodprti injekcijski peresnik shranjuje pri temperaturi do 25 °C do tri mesece, brez ponovnega shranjevanja v hladilniku.
English: Do not pass it on to others.
Slovenian: Ne privijajte je.
English: Bemfola 150 IU/0.25 mL (11 micrograms/0.25 mL) is not designed to allow the cartridge to be removed.
Slovenian: Zdravilo Bemfola 150 i.e./0,25 ml (11 mikrogramov/0,25 ml) je oblikovano tako, da ne dopušča odstranitve vložka.
English: Each mL of the solution contains 600 IU equivalent to 44 micrograms.
Slovenian: En mililiter raztopine vsebuje 600 i.e. (kar ustreza 44 mikrogramom).
English: There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple treatment regimens for infertility treatment.
Slovenian: Pri ženskah, ki so bile vključene v več režimov zdravljenja neplodnosti, so poročali o benignih in malignih novotvorbah na jajčnikih in drugih delih reprodukcijskega sistema.
English: • Bemfola 225 IU/0.375 mL: Each cartridge contains 225 IU (equivalent to 16.5 micrograms) follitropin alfa in 0.375 mL solution.
Slovenian: Bemfola 225 i.e./0,375 ml: En vložek vsebuje 225 i.e. (kar ustreza 16,5 mikrograma) folitropina alfa v 0,375 ml raztopine.
English: • Bemfola 75 IU/0.125 mL: Each cartridge contains 75 IU (equivalent to 5.5 micrograms) follitropin alfa in 0.125 mL solution.
Slovenian: Bemfola 75 i.e./0,125 ml: En vložek vsebuje 75 i.e. (kar ustreza 5,5 mikrograma) folitropina alfa v 0,125 ml raztopine.
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.
Slovenian: Ko je dosežen optimalen odziv, se injicira ena sama 250-mikrogramska injekcija r-hCG ali 5.000 i.e. do 10.000 i.e. hCG 24 do 48 ur po zadnji injekciji folitropina alfa in lutropina alfa.
English: Each pre-filled pen delivers 150 IU follitropin alfa, equivalent to 11 micrograms per 0.25 mL.
Slovenian: En napolnjen injekcijski peresnik zagotavlja odmerek 150 i.e. folitropina alfa, kar ustreza 11 mikrogramom, v 0,25 ml.