FrancophonIA/ELRC3.0 huggingface dataset:
English: • Medically assisted reproduction programs, for instance IVF A starting dose is set by your doctor.
Slovenian: • Programi oploditve z biomedicinsko pomočjo, na primer IVF Začetni odmerek določi zdravnik.
English: Restricted to women with ovulation induced (follitropin beta, n = 76; u-FSH, n = 42).
Slovenian: Omejeno na ženske s sproženo ovulacijo (Fertavid, n = 76; u-FSH, n = 42).
English: In women with generally recognised risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia, treatment with gonadotropins, including Fertavid, may further increase this risk.
Slovenian: Pri ženskah s splošno znanimi dejavniki tveganja za trombembolične dogodke, npr. z osebno ali družinsko anamnezo, hudo debelostjo ali trombofilijo, lahko zdravljenje z gonadotropini, vključno z zdravilom Fertavid, dodatno poveča takšno tveganje.
English: • if you are severely overweight.
Slovenian: • če imate zelo prekomerno telesno maso.
English: After treatment with gonadotrophin preparations, there is an increased chance of having multiple pregnancies, even when only one embryo is transferred into the uterus.
Slovenian: Po zdravljenju z zdravili z gonadotropinom obstaja večja možnost za večplodno nosečnost, tudi če je v maternico prenesen le en zarodek.
English: If a patient has not responded after this period, the combination therapy may be continued; current clinical experience indicates that treatment for up to 18 months or longer may be necessary to achieve spermatogenesis.
Slovenian: Če v tem času ni opaziti odziva, zdravljenje s kombinacijo omenjenih zdravil lahko nadaljujete; sedanje klinične izkušnje kažejo, da je lahko potrebno 18 mesecev ali več, da dosežemo spermatogenezo.
English: To find the right dosage, your doctor will check your follicle growth by means of ultrasound scanning, and measurement of the amount of oestradiol (female sex hormone) in the blood.
Slovenian: Za določitev pravega odmerka bo zdravnik opazoval rast folikla z ultrazvočno preiskavo in meril količino estradiola (ženskega spolnega hormona) v krvi.
English: Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.
Slovenian: Zato je zgodnja ultrazvočna preiskava, ki potrjuje maternično nosečnost, zelo pomembna.
English: Paediatric population There is no relevant use of Fertavid in the paediatric population for the approved indication.
Slovenian: Pediatrična populacija Ustrezne uporabe zdravila Fertavid v pediatrični populaciji za odobreno indikacijo ni.
English: • have adrenal glands that are not working properly (adrenocortical insufficiency)
Slovenian: • če vam nadledvični žlezi ne delujeta pravilno (adrenokortikalna insuficienca),
English: What Fertavid is and what it is used for
Slovenian: Kaj je zdravilo Fertavid in za kaj ga uporabljamo
English: The absolute bioavailability of subcutaneously administered Fertavid is approximately 77%.
Slovenian: Absolutna biološka razpoložljivost subkutano danega zdravila Fertavid je približno 77 %.
English: In women undergoing Assisted Reproduction Technologies (ART) procedures, the risk of a multiple pregnancy is mainly related to the number of embryos transferred.
Slovenian: Pri ženskah v postopku oploditve z biomedicinsko pomočjo (ART) je tveganje za večplodno nosečnost v glavnem povezano s številom prenesenih zarodkov.
English: Based on the results of comparative clinical studies, it is considered appropriate to give a lower total dosage of Fertavid over a shorter treatment period than generally used for urinary FSH, not only in order to optimise follicular development but also to reduce the risk of unwanted ovarian hyperstimulation (see section 5.1).
Slovenian: Na osnovi rezultatov primerjalnih kliničnih študij se je izkazalo, da je primernejše dati manjše celotne odmerke zdravila Fertavid v krajšem obdobju zdravljenja, kot se običajno dajejo pri urinskem FSH, ne le z namenom optimizacije razvoja folikla temveč tudi za zmanjšanje tveganja za neželeno hiperstimulacijo jajčnikov (glejte poglavje 5.1).
English: Important information about some of the ingredients of Fertavid
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Fertavid
English: Ovarian torsion may be associated with other risk factors such as OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovaries.
Slovenian: Torzija jajčnikov je lahko povezana z drugimi dejavniki tveganja, kot so OHSS, nosečnost, predhodni abdominalni kirurški poseg, torzija jajčnikov v pretekli anamnezi, pretekla ali obstoječa cista na jajčnikih in policistični jajčniki.
English: For anovulatory women undergoing ovulation induction, monitoring follicular development with transvaginal ultrasonography may aid in determining whether or not to continue the cycle in order to reduce the risk of multiple pregnancies.
Slovenian: Pri ženskah brez ovulacij, pri katerih poteka indukcija ovulacije, lahko spremljanje razvoja foliklov s transvaginalno ultrazvočno preiskavo pomaga pri odločitvi, ali naj se ciklus nadaljuje ali ne, da bi zmanjšali tveganje za večplodno nosečnost.
English: Fertavid has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Fertavid nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: The volume of the syringe should be small enough so that the prescribed dose can be given with reasonable accuracy.
Slovenian: Prostornina brizge mora biti dovolj majhna, da omogoča primerno natančno dajanje predpisanega odmerka.
English: This leaflet was last revised in Month YYYY.
Slovenian: Navodilo je bilo nazadnje revidirano dne
English: Since follicles of over 14 mm may lead to pregnancies, multiple pre-ovulatory follicles exceeding 14 mm carry the risk of multiple gestations.
Slovenian: Ker folikli s premerom, večjim od 14 mm, lahko omogočijo nosečnost, multipli predovulacijski folikli s premerom, večjim od 14 mm, predstavljajo tveganje za večplodno nosečnost.
English: In men, FSH is needed for the production of sperm.
Slovenian: Pri moških pa je FSH potreben za nastajanje sperme.
English: • if you already know you have an increased chance of having thrombosis
Slovenian: • če veste, da imate povečano tveganje za nastanek tromboze,
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.
Slovenian: Pri uporabi injekcijskega peresnika je treba upoštevati, da je peresnik natančen pripomoček, ki natančno injicira nastavljeni odmerek.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na injekcijo, kar v bistvu pomeni 'brez natrija'.
English: Antibiotic hypersensitivity reactions
Slovenian: Preobčutljivostne reakcije za antibiotike
English: Your doctor will do ultrasound scans of your ovaries to carefully monitor the number of maturing follicles.
Slovenian: Zdravnik bo izvajal ultrazvočne preiskave jajčnikov, da bo natančno spremljal število dozorevajočih foliklov.
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).
Slovenian: Pri približno 4 % žensk, v kliničnih preskušanjih zdravljenih s folitropinom beta, so poročali o sindromu hiperstimulacije jajčnikov (OHSS) (glejte poglavje 4.4).
English:  Regular monitoring of the response to FSH-treatment helps to prevent ovarian overstimulation.
Slovenian:  Redno spremljanje odziva na zdravljenje s FSH pomaga preprečiti prekomerno stimulacijo jajčnikov.
English: Your doctor may also check blood hormone levels.
Slovenian: Zdravnik vam bo morda kontroliral tudi koncentracijo hormonov v krvi.
English: In women, FSH is needed for the growth and development of follicles in the ovaries.
Slovenian: Pri ženskah je FSH potreben za rast in razvoj foliklov v jajčnikih.
English: Other medicines and Fertavid
Slovenian: Druga zdravila in zdravilo Fertavid
English: To assess the response, semen analysis is recommended 4 to 6 months after the beginning of treatment.
Slovenian: Za oceno odziva pri bolniku je priporočljivo opraviti analizo sperme 4 do 6 mesecev po začetku zdravljenja.
English: Treatment with Fertavid, just as pregnancy itself, may increase the risk of having a blood clot (thrombosis).
Slovenian: Zdravljenje z zdravilom Fertavid, prav tako kot sama nosečnost, lahko poveča tveganje za krvni strdek (trombozo).
English: For posology and method of administration, see section 4.2.
Slovenian: Za odmerjanje zdravila in način uporabe glejte poglavje 4.2.
English: • Controlled ovarian hyperstimulation in medically assisted reproduction programs Various stimulation protocols are applied.
Slovenian: • Nadzorovana hiperstimulacija jajčnikov pri programih oploditve z biomedicinsko pomočjo Uporabljamo več različnih stimulacijskih protokolov.
English: When given under the skin the injection may, in some cases, be given by yourself or your partner.
Slovenian: Podkožno (subkutano) injekcijo si lahko v nekaterih primerih date sami ali vam jo da vaš partner.
English: It is not known if treatment with fertility medicines increases the risk of these tumours in infertile women.
Slovenian: Ni znano, ali zdravljenje z zdravili za plodnost poveča tveganje za takšne tumorje pri neplodnih ženskah.
English: • Fertavid may contain traces of streptomycin and/or neomycin.
Slovenian: • Zdravilo Fertavid lahko vsebuje sledi streptomicina in/ali neomicina.
English: You may regularly have ultrasound scans of the ovaries.
Slovenian: Lahko boste imeli redne ultrazvočne preiskave jajčnikov.
English: Clean about two inches around the point where the needle will go in and let the disinfectant dry for at least one minute before you proceed.
Slovenian: Očistite približno 5 cm okoli mesta vboda in počakajte vsaj eno minuto, da se razkužilo posuši, preden nadaljujete.
English: Injections may be given slowly into a muscle (for instance in the buttock, upper leg or upper arm) or under the skin (in the lower stomach, for example).
Slovenian: Injekcijo lahko dajemo počasi v mišico (npr. v zadnjico, stegno ali nadlaket) ali pod kožo (npr. v spodnji del trebuha).
English: Do not use Fertavid after the expiry date which is stated on the label and carton after 'EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake ‘EXP'.
English: Fertavid can thus be used to stimulate follicular development and steroid production in selected cases of disturbed gonadal function.
Slovenian: Zdravilo Fertavid se torej lahko uporablja za spoodbujanje razvoja foliklov in tvorbe steroidov v izbranih primerih, kjer je moteno delovanje gonad.
English: Treatment with Fertavid should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Slovenian: Zdravljenje z zdravilom Fertavid je treba začeti pod nadzorom zdravnika, izkušenega na področju zdravljenja neplodnosti.
English: No data on acute toxicity of Fertavid in humans is available, but the acute toxicity of Fertavid and of urinary gonadotrophin preparations in animal studies has been shown to be very low.
Slovenian: Podatkov o akutni toksičnosti zdravila Fertavid pri ljudeh ni na voljo, vendar so poskusi na živalih pokazali, da je akutna toksičnost zdravila Fertavid in urinskih gonadotropinov zelo majhna.
English: After subcutaneous administration of Fertavid, maximum concentration of FSH is reached within about 12 hours.
Slovenian: Po subkutanem dajanju zdravila Fertavid je maksimalna koncentracija FSH dosežena v času približno 12 ur.
English: In these women the benefits of gonadotropin administration, including Fertavid, need to be weighed against the risks.
Slovenian: Pri teh ženskah je treba koristi uporabe gonadotropinov, vključno z zdravilom Fertavid, pretehtati v primerjavi s tveganji.
English: • are a man and are infertile because of a condition called primary testicular failure.
Slovenian: • če ste moški in ste neplodni zaradi bolezni, ki ji pravimo primarna odpoved mod.
English: No teratogenic effect has been observed in animal studies.
Slovenian: Tudi študije na živalih niso pokazale teratogenih učinkov.
English: It was shown that on average an 18% higher amount of FSH is given with the pen compared with a conventional syringe.
Slovenian: Pokazali so, da s peresnikom injiciramo v povprečju 18 % večjo količino FSH kot z navadno brizgo.
English: Fertavid is unlikely to affect your ability to drive or use machines.
Slovenian: Malo verjetno je, da bi zdravilo Fertavid vplivalo na vašo sposobnost vožnje in upravljanja strojev.
English: Multiple gestation, especially high order, carries an increased risk of adverse maternal (pregnancy and delivery complications) and perinatal (low birth weight) outcomes.
Slovenian: Večplodno nosečnost (zlasti številčnejšo) spremlja večje tveganje za neželene maternalne (zapleti med nosečnostjo in porodom) in perinatalne (nizka porodna masa) izide.
English: The daily dose is then maintained until a follicle of proper size is present.
Slovenian: Dnevni odmerek vam bo potem vzdrževal, dokler ne bo prisoten folikel primerne velikosti.
English: • Anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate.
Slovenian: • odsotnost ovulacije (vključno s sindromom policističnih jajčnikov (PCOS - polycystic ovarian syndrome)) pri ženskah, pri katerih je bilo zdravljenje s klomifenijevim citratom neuspešno;
English: The treatment period equals the development time of sperm and the time in which improvement can be expected.
Slovenian: Zdravljenje traja tako dolgo, kot je potrebno za razvoj sperme, in v obdobju, ko lahko pričakujemo izboljšanje.
English: Pain in the stomach, feeling sick or diarrhoea are the first symptoms.
Slovenian: Bolečina v trebuhu, slabost ali driska so lahko prvi znaki.
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.
Slovenian: Zdravilo Fertavid se običajno predpisuje v odmerku 450 i.e. na teden; večinoma v 3 odmerkih po 150 i.e. v kombinaciji z drugim hormonom (hCG), najmanj 3 do 4 mesece.
English: OHSS may be caused by administration of human Chorionic Gonadotropin (hCG) and by pregnancy (endogenous hCG).
Slovenian: OHSS lahko povzročita uporaba humanega horionskega gonadotropina (hCG) in nosečnost (endogeni hCG).
English: In clinical studies comparing recFSH (follitropin beta) and urinary FSH for controlled ovarian stimulation in women participating in an assisted reproduction technology (ART) program and for ovulation induction (see tables 1 and 2 below), follitropin beta 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 študijah, kjer so primerjali uporabo rekombinantnega FSH (folitropina beta) in urinskega FSH za nadzorovano stimulacijo jajčnikov pri ženskah, ki so sodelovale v programu oploditve z biomedicinsko pomočjo in za indukcijo ovulacije (glejte preglednici 1 in 2 spodaj), je bilo zdravilo Fertavid učinkovitejše od urinskega FSH v smislu manjšega celotnega odmerka in krajšega obdobja zdravljenja, ki je bilo potrebno za začetek zorenja foliklov.
English: When a sufficient number of follicles of proper size are present, the final phase of maturation of the follicles is induced by giving hCG. Retrieval of the egg(s) is performed 34-35 hours later.
Slovenian: Ko je prisotno zadostno število foliklov primerne velikosti, vam bo zdravnik sprožil končno fazo zorenja foliklov z dajanjem hCG, 34 do 35 ur pozneje pa bo opravil punkcijo jajčeca (jajčec).
English: Elevated endogenous FSH levels in men are indicative of primary testicular failure.
Slovenian: Zvišane vrednosti endogenega FSH pri moških so znak primarne odpovedi testisov.
English: • are allergic to follitropin beta or any of the other ingredients of Fertavid (listed in section 6)
Slovenian: • če ste alergični na folitropin beta ali katero koli sestavino zdravila Fertavid (navedeno v poglavju 6),
English: Primary Testicular Failure
Slovenian: Primarna odpoved testisov
English: This dose is continued for at least the first four days.
Slovenian: Prejemali ga boste najmanj prve štiri dni.
English: Pinch the skin a little.
Slovenian: Kožo nežno stisnite v gubo.
English: Too high a dosage of FSH may lead to hyperstimulation of the ovaries (see section 4.4).
Slovenian: Preveliki odmerki FSH lahko povzročijo hiperstimulacijo jajčnikov (glejte poglavje 4.4).
English: Contact your doctor immediately if you are experiencing stomach pains, also if this occurs some days after the last injection has been given.
Slovenian: V primeru bolečin v trebuhu se nemudoma posvetujte z zdravnikom, tudi če se bolečine pojavijo nekaj dni po prejemu zadnje injekcije.
English: • have high prolactin levels in the blood (hyperprolactinemia)
Slovenian: • če imate visoko koncentracijo prolaktina v krvi (hiperprolaktinemija),
English: Pre-ovulatory conditions are reached when there is ultrasonographic evidence of a dominant follicle of at least 18 mm in diameter and/or when plasma oestradiol levels of 300-900 picograms/mL (1,000-3,000 pmol/L) are attained.
Slovenian: Predovulacijski pogoji so doseženi tedaj, ko ultrazvočna preiskava pokaže prisotnost dominantnega folikla s premerom najmanj 18 mm in/ali ko plazemske vrednosti estradiola dosežejo 300 do 900 pikogramov/ml (1.000 do 3.000 pmol/l).
English: Single-dose administration of Fertavid to rats induced no toxicologically significant effects.
Slovenian: Enkraten odmerek zdravila Fertavid pri podganah ni povzročil pomembnih toksikoloških učinkov.
English: Ovarian overstimulation may develop into a medical condition called ovarian hyperstimulation syndrome (OHSS), which can be a serious medical problem.
Slovenian: Prekomerna stimulacija jajčnikov se lahko razvije v bolezensko stanje, ki ga imenujemo sindrom hiperstimulacije jajčnikov (OHSS) in je lahko resna zdravstvena težava.
English: • heart attack
Slovenian: • srčni infarkt,
English: Ovarian response is monitored by ultrasound assessment.
Slovenian: Odziv jajčnikov se spremlja z ultrazvočnimi preiskavami.
English: In women undergoing assisted reproduction techniques, including in vitro fertilisation (IVF) and other methods, Fertavid can bring about the development of multiple follicles.
Slovenian: Pri ženskah, ki so v postopku oploditve z biomedicinsko pomočjo, vključno z zunajtelesno oploditvijo (IVF - in vitro fertilisation) in drugimi metodami, zdravilo Fertavid lahko povzroči razvoj večkratnih foliklov.
English: What Fertavid is and what it is used for What you need to know before you use Fertavid How to use Fertavid
Slovenian: Kaj je zdravilo Fertavid in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Fertavid Kako uporabljati zdravilo Fertavid Možni neželeni učinki
English: If you forget to use Fertavid
Slovenian: Če ste pozabili uporabiti zdravilo Fertavid
English: Please discuss this with your doctor, before starting treatment, especially:
Slovenian: Pred začetkom zdravljenja se posvetujte z zdravnikom, še posebej:
English: Local reactions at the site of injection include induration and pain.
Slovenian: Med lokalne reakcije na mestu injiciranja sodita zatrdlina in bolečina.
English: If Fertavid is used in a combination with clomifene citrate, the effect of Fertavid may be increased.
Slovenian: Če uporabljate zdravilo Fertavid v kombinaciji s klomifenijevim citratom, se učinek zdravila Fertavid lahko poveča.
English: When given into a muscle the injection should be given by the doctor or nurse.
Slovenian: Injekcijo v mišico lahko dajeta le zdravnik ali medicinska sestra.
English: Fertavid solution for injection (injection) is a clear, colourless liquid.
Slovenian: Fertavid raztopina za injiciranje (injekcija) je bistra, brezbarvna tekočina.
English: Self-administration of Fertavid should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.
Slovenian: Bolniki si lahko zdravilo Fertavid dajejo sami le, če so motivirani, primerno poučeni in imajo možnost posvetovati se s strokovnjakom.
English: Please put the day of first use of the cartridge on the dosing record table as shown in the Instruction Manual of the Puregon Pen.
Slovenian: Vpišite datum prve uporabe vložka v tabelo za evidenco odmerkov, kot je prikazano v priročniku za uporabo peresnika Puregon Pen.
English: What you need to know before you use Fertavid
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Fertavid
English: • have heavy or irregular vaginal bleeding where the cause is unknown
Slovenian: • če imate močne ali neredne krvavitve iz nožnice brez znanega vzroka,
English: Rare side effects (may affect up to 1 in 1,000 people): - Blood clots (this may also occur in the absence of unwanted overstimulation of the ovaries, see warnings and precautions in section 2)
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnic): - krvni strdki (ti se lahko pojavijo tudi brez neželene prekomerne stimulacije jajčnikov, glejte razdelek Opozorila in previdnostni ukrepi v 2. poglavju)
English: To check the effects of treatment, your doctor may ask you for a semen sample to be analysed, four to six months after the start of treatment.
Slovenian: Zaradi nadzora učinkovitosti zdravljenja vas bo zdravnik lahko napotil na analizo vzorca sperme štiri do šest mesecev po začetku zdravljenja.
English: Rates of pregnancy loss in women undergoing assisted reproduction techniques are higher than in the normal population.
Slovenian: Število splavov pri ženskah v postopku oploditve z biomedicinsko pomočjo je večje kot pri normalni populaciji.
English: When used for an ovulation induction cycle, appropriate FSH dose adjustment(s) should prevent multiple follicle development.
Slovenian: Če je FSH uporabljen za ciklus indukcije ovulacije, bi morala ustrezna prilagoditev odmerka/odmerkov FSH preprečiti razvoj več foliklov.
English: Air bubbles must be removed from the cartridge before injection (see instructions for using the pen).
Slovenian: Pred injiciranjem morate iz vložka odstraniti zračne mehurčke (glejte navodila za uporabo peresnika).
English: Congenital Malformations
Slovenian: Prirojene malformacije
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).
Slovenian: Takoj pokličite zdravnika, če opazite hudo otekanje trebuha, bolečine v trebuhu, slabost v želodcu (siljenje na bruhanje), bruhanje, nenadno povečanje telesne mase zaradi kopičenja tekočine, drisko, zmanjšano izločanje urina ali težave z dihanjem (glejte tudi poglavje 4, Možni neželeni učinki).
English: To prevent painful injections and minimise leakage from the injection site Fertavid should be slowly administered intramuscularly or subcutaneously.
Slovenian: Da preprečite bolečino in zmanjšate iztekanje na mestu injiciranja, je treba zdravilo Fertavid dati bolniku počasi intramuskularno ali subkutano.
English: Distribution, biotransformation and elimination Recombinant FSH is biochemically very similar to urinary human FSH and is distributed, metabolised, and excreted in the same way.
Slovenian: Rekombinantni FSH je biokemično zelo podoben humanemu urinskemu FSH in se porazdeli, presnovi in izloči na enak način.
English: In case of inadvertent exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of recombinant FSH.
Slovenian: V primeru nenamerne uporabe med nosečnostjo ne moremo izključiti možnosti teratogenih učinkov rekombinantnega FSH zaradi pomanjkanja kliničnih podatkov.
English: Any blood sucked back into the syringe means that the needle tip has penetrated a vein or artery.
Slovenian: Če pri tem v brizgo priteče kri, to pomeni, da je vrh igle predrl veno ali arterijo.