FrancophonIA/ELRC3.0 huggingface dataset:
English: In a commonly used protocol, follitropin alfa is started approximately 2 weeks after the start of agonist treatment, both being continued until adequate follicular development is achieved.
Slovenian: Po protokolu, ki se splošno uporablja, se zdravljenje s folitropinom alfa začne približno 2 tedna po začetku zdravljenja z agonistom in se nadaljuje z dajanjem obeh zdravil, dokler ni dosežen zadosten folikularni razvoj.
English: Table 2: Adverse reactions in men System organ class
Slovenian: Preglednica 2: Neželeni učinki pri moških Organski sistem
English: Semen analysis is recommended 4 to 6 months after the beginning of treatment as part of the assessment of the response.
Slovenian: Kot del ocenjevanja odziva se priporoča analiza semenske tekočine 4 do 6 mesecev po začetku zdravljenja.
English: Women with anovulation (including polycystic ovarian syndrome) Follitropin alfa may be given as a course of daily injections.
Slovenian: Ženske z anovulacijo (vključno s sindromom policističnih jajčnikov) Folitropin alfa se lahko daje kot zaporedje dnevnih injekcij.
English: • You will use these two medicines each day for up to 5 weeks.
Slovenian: • Ti dve zdravili boste naslednjih pet tednov uporabljali vsak dan.
English: • When you get the desired response, you will be given hCG or “recombinant hCG” (r-hCG, an hCG made in a laboratory by a special DNA technique).
Slovenian: • Ko boste dosegli želeni odziv, boste prejeli hCG ali "rekombinantni hCG" (r-hCG, v laboratoriju izdelan hCG s posebno tehnologijo DNA).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 September 2013.
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 27. september 2013 Datum zadnjega podaljšanja: 16. maja 2018
English: If your doctor decides to try Ovaleap treatment, they may monitor it by asking you to provide semen for analysis 4 to 6 months after starting treatment.
Slovenian: Če se zdravnik odloči, da vas bo poskusil zdraviti z zdravilom Ovaleap, vas bo za spremljanje vašega zdravljenja 4 do 6 mesecev po začetku zdravljenja morda prosil za vzorce sperme za analizo.
English: Do not attempt to self-administer this medicine without this training by your doctor or nurse.
Slovenian: Tega zdravila si ne poskušajte injicirati sami, če vas o tem nista ustrezno poučila vaš zdravnik ali medicinska sestra.
English: Follitropin alfa is a potent gonadotropic 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 učinke in jo zato smejo uporabljati samo zdravniki, ki dobro poznajo težave z neplodnostjo in njihovo obvladovanje.
English: Driving and using machines This medicine does not affect your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev To zdravilo ne vpliva na sposobnost vožnje ali upravljanja strojev.
English: • The usual starting dose of this medicine is 150 to 225 IU each day, from day 2 or 3 of your menstrual cycle.
Slovenian: • Običajni začetni odmerek tega zdravila je 150 do 225 i.e. vsak dan, od 2. ali 3. dneva vašega menstrualnega ciklusa.
English: • The maximum daily dose of this medicine is usually not higher than 225 IU.
Slovenian: • Največji dnevni odmerek tega zdravila običajno ne presega 225 i.e..
English: Patients with porphyria or a family history of porphyria should be closely monitored during treatment with follitropin alfa.
Slovenian: Bolnike s porfirijo ali s porfirijo v družinski anamnezi moramo med zdravljenjem s folitropinom alfa skrbno nadzorovati.
English: Treatment with follitropin alfa should be initiated under the supervision of a physician experienced in the treatment of fertility disorders.
Slovenian: Zdravljenje s folitropinom alfa se mora pričeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem motenj plodnosti.
English: Independent risk factors for developing OHSS include polycystic ovarian syndrome high absolute or rapidly rising serum oestradiol levels (e.g. > 900 pg/mL or > 3,300 pmol/L in anovulation; > 3,000 pg/mL or > 11,000 pmol/L in ART) and large number of developing ovarian follicles (e.g. > 3 follicles of ≥ 14 mm in diameter in anovulation; ≥ 20 follicles of ≥ 12 mm in diameter in ART).
Slovenian: Neodvisni dejavniki tveganja za razvoj OHSS vključujejo sindrom policističnih jajčnikov, visoke absolutne ali hitro naraščajoče ravni estradiola v serumu (npr. > 900 pg/ml ali > 3.300 pmol/l v anovulaciji; > 3.000 pg/ml ali > 11.000 pmol/l v ART) in veliko število razvijajočih se ovarijskih foliklov (npr. > 3 folikli s premerom ≥ 14 mm v anovulaciji; ≥ 20 foliklov premera ≥ 12 mm v ART).
English: For instructions on the administration with the Ovaleap Pen, see section 6.6.
Slovenian: Za navodilo o dajanju zdravila z injekcijskim peresnikom Ovaleap Pen glejte poglavje 6.6.
English: The instructions for use of the pen must be followed carefully.
Slovenian: Navodila za uporabo injekcijskega peresnika je treba natančno upoštevati.
English: In women, the most important effect resulting from parenteral administration of FSH is the development of mature Graafian follicles.
Slovenian: Pri ženskah je najpomembnejši učinek po parenteralni uporabi FSH razvoj zrelih Graafovih foliklov.
English: If you experience the above symptoms your doctor might ask you to stop using this medicine (see also section 4 under “Serious side effects in women").
Slovenian: Če se pojavijo zgornji simptomi, vas bo morda zdravnik prosil, da zdravilo prenehate uporabljati (glejte tudi poglavje 4 "Neželeni učinki pri ženskah").
English: When being conceived by assisted reproductive technology, a baby may have a slightly higher risk of birth defects than after natural conception.
Slovenian: Pri zanositvi s tehnikami asistirane reprodukcije ima otrok lahko nekoliko večje tveganje za prirojene napake kot pri naravni zanositvi.
English: If you are not sure, talk to your doctor or pharmacist before using this medicine.
Slovenian: Če niste prepričani, se pred začetkom jemanja tega zdravila posvetujte z zdravnikom ali farmacevtom.
English: Ovaleap is indicated for use in infertility (see section 4.1).
Slovenian: Zdravilo Ovaleap je indicirano za uporabo pri neplodnosti (glejte poglavje 4.1).
English: • gynaecological haemorrhages of unknown aetiology;
Slovenian: • ginekološka krvavitev neznane etiologije
English: When using this medicine, you have a higher risk of being pregnant with more than one child (i.e. “multiple pregnancy”, typically twins) than if you conceived naturally.
Slovenian: Pri uporabi tega zdravila je tveganje za nosečnost z več plodi večja (npr. "večplodna nosečnost", običajno dvojčki) kot pri naravni zanositvi.
English: In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/L.
Slovenian: V kliničnih študijah so bile te bolnice določene na podlagi ravni endogenega LH v serumu < 1,2 i.e./l.
English: Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated.
Slovenian: Pred začetkom zdravljenja se mora primerno oceniti neplodnost para ter ovrednotiti domnevne kontraindikacije za nosečnost.
English: If you notice any of the above-listed side effects you should immediately contact your doctor who may ask you to stop using Ovaleap.
Slovenian: Če opazite katerega koli od zgoraj navedenih neželenih učinkov, se takoj posvetujte z zdravnikom, ki vam bo morda svetoval da prenehate uporabljati zdravilo Ovaleap.
English: • OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty in breathing and/or possible fluid accumulation in your stomach or chest.
Slovenian: • OHSS lahko postane resen z izrazito povečanimi jajčniki, zmanjšanim nastajanjem urina, s pridobivanjem telesne mase, težavami dihanja in/ali morebitnim nabiranjem tekočine v trebuhu ali prsnem košu.
English: There is no indication for use of Ovaleap during pregnancy.
Slovenian: Za uporabo zdravila Ovaleap med nosečnostjo ni indikacij.
English: Therefore, if signs of ovarian hyperstimulation occur such as serum oestradiol level > 5,500 pg/mL or > 20,200 pmol/L and/or ≥ 40 follicles in total, it is recommended that hCG be withheld and the patient be advised to refrain from coitus or to use barrier contraceptive methods for at least 4 days.
Slovenian: Zato je v primeru pojava znakov hiperstimulacije jajčnikov, kot so ravni estradiola v serumu > 5.500 pg/ml ali > 20.200 pmol/l in/ali skupno ≥40 foliklov, priporočljivo, da se opusti dajanje hCG in se bolnici svetuje, da se vzdrži spolnih odnosov ali uporablja mehanska kontracepcijska sredstva najmanj 4 dni.
English: In women, FSH is needed for the growth and development of the sacs (follicles) in the ovaries that contain the egg cells.
Slovenian: Pri ženskah je FSH potreben za rast in razvoj jajčnih mehurčkov (foliklov) v jajčnikih.
English: In women, safe and effective use of follitropin alfa calls for monitoring of ovarian response with ultrasound, alone or preferably in combination with measurement of serum oestradiol levels, on a regular basis.
Slovenian: Pri ženskah je za varno in učinkovito uporabo folitropina alfa potrebno redno nadzorovanje odziva jajčnikov z ultrazvokom ali še bolje z ultrazvokom v kombinaciji z merjenjem serumskih ravni estradiola.
English: Safety, efficacy and pharmacokinetics of follitropin alfa in patients with renal or hepatic impairment have not been established.
Slovenian: Varnost, učinkovitost in farmakokinetika folitropina alfa pri bolnikih z ledvično ali jetrno okvaro niso bili dokazani.
English: • in combination with a medicine called “lutropin alfa” (a version of another gonadotropin, “luteinising hormone” or LH) to help ovulation in women that are not ovulating because their body is producing too little FSH and LH.
Slovenian: • v kombinaciji z drugim zdravilom, ki se imenuje "lutropin alfa" (različica drugega gonadotropina, "luteinizirajočega hormona" ali LH) za pomoč pri ovulaciji pri ženskah, ki nimajo ovulacije, ker njihovo telo proizvaja premalo FSH in LH.
English: Before the treatment is started you and your partner's fertility should be evaluated by a doctor experienced in treating fertility disorders.
Slovenian: Pred začetkom zdravljenja mora plodnost vas in vaše partnerke/partnerja oceniti zdravnik z izkušnjami pri zdravljenju motenj plodnosti.
English: • fibroid tumours of the uterus incompatible with pregnancy;
Slovenian: • fibroidni tumorji maternice, ki niso združljivi z nosečnostjo
English: Marketing Authorisation Holder Theramex Ireland Limited 3rd Floor, Kilmore House,
Slovenian: Imetnik dovoljenja za promet z zdravilom Theramex Ireland Limited 3rd Floor, Kilmore House,
English: Exacerbation or aggravation of asthma
Slovenian: • poslabšanje astme
English: If a patient fails to respond adequately after 4 weeks of treatment, that cycle should be abandoned and the patient should undergo further evaluation after which she may recommence treatment at a higher starting dose than in the abandoned cycle.
Slovenian: Če pri bolnici ni zadovoljivega odziva na zdravljenje po 4 tednih, se mora ta ciklus zdravljenja opustiti, bolnico ponovno oceniti, nato pa bo morda morala ponovno zdravljenje začeti z večjim začetnim odmerkom kot v opuščenem ciklusu.
English: Then Ovaleap is given approximately 2 weeks after the start of agonist treatment.
Slovenian: Nato se približno 2 tedna po začetku zdravljenja z agonistom daje zdravilo Ovaleap.
English: Merckle GmbH Graf-Arco-Straße 3 89079 Ulm, Germany
Slovenian: Merckle GmbH Graf-Arco-Straße 3 89079 Ulm, Nemčija
English: Clinical evaluation may reveal hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, or acute pulmonary distress.
Slovenian: Klinična ocena lahko razkrije hipovolemijo, hemokoncentracijo, elektrolitsko neravnovesje, ascites, hemoperitonej, plevralni izliv, hidrotoraks ali akutno respiratorno stisko.
English: Do not use Ovaleap:
Slovenian: Ne uporabljajte zdravila Ovaleap:
English: If you are not ovulating and if the recommended dose and timing are followed, the occurrence of OHSS is less likely.
Slovenian: Če nimate ovulacije in upoštevate priporočeni odmerek in čas, je manj verjetno, da bi se pojavil sindrom hiperstimulacije jajčnikov.
English: • Your dose of this medicine may be increased every 7 or every 14 days by 37.5 to 75 IU, until you get the desired response.
Slovenian: • Vaš odmerek tega zdravila se lahko poveča vsakih 7 ali 14 dni za 37,5 do 75 i.e., dokler ne boste dosegli želenega odziva.
English: If you forget to use Ovaleap
Slovenian: Če ste pozabili uporabiti zdravilo Ovaleap
English: Luteal phase support may be considered since lack of substances with luteotropic 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 (LH/hCG) po ovulaciji vodi do prezgodnje odpovedi rumenega telesca.
English: When undergoing assisted reproductive technology the risk of having a multiple pregnancy is related to your age, the quality and number of fertilised eggs or embryos placed inside you.
Slovenian: Pri uporabi tehnik asistirane reprodukcije je tveganje za večplodno nosečnost povezano z vašo starostjo in kakovostjo ter številom prenesenih oplojenih jajčec ali embrijev.
English: Comparative clinical studies have shown that on average patients require a lower cumulative dose and shorter treatment duration with follitropin alfa compared with urinary FSH.
Slovenian: Primerjalne klinične študije so pokazale, da potrebuje bolnik v povprečju nižji skupni odmerek in krajše trajanje zdravljenja s folitropinom alfa kot z urinarnim FSH.
English: • if you are allergic to follitropin alfa, Follicle Stimulating Hormone (FSH) or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na folitropin alfa, folikle stimulirajoči hormon (FSH) ali katero koli sestavino tega zdravila, navedeno v poglavju 6.
English: In patients undergoing ovulation induction, the incidence of multiple pregnancy is increased compared with natural conception.
Slovenian: Pri bolnicah v postopku indukcije ovulacije je pogostnost večplodne nosečnosti, v primerjavi z naravno zanositvijo, povečana.
English: Impaired fertility has been reported in rats exposed to pharmacological doses of follitropin alfa (≥ 40 IU/kg/day) for extended periods, through reduced fecundity.
Slovenian: O okvarah plodnosti so poročali pri podganah, ki so bile izpostavljene farmakološkim odmerkom folitropina alfa (≥ 40 i.e./kg/dan) skozi daljše obdobje, in sicer v obliki zmanjšane plodnosti.
English: No direct comparison of follitropin alfa/LH versus human menopausal gonadotropin (hMG) has been performed.
Slovenian: Direktna primerjava med folitropinom alfa/LH in humanim menopavzalnim gonadotropinom (hMG) ni bila izvedena.
English: Safety and effectiveness of follitropin alfa in elderly patients have not been established.
Slovenian: Varnost in učinkovitost folitropina alfa pri starejših bolnikih nista bili dokazani.
English: If you are developing OHSS your doctor may not give you any hCG in this treatment cycle.
Slovenian: Če se pri vas razvije sindrom hiperstimulacije jajčnikov, vam zdravnik ne sme dati hCG v tem ciklusu zdravljenja.
English: *Follitropin alfa (recombinant human follicle-stimulating hormone [r-hFSH]) is produced in Chinese Hamster Ovary Cells (CHO DHFR-) by recombinant DNA technology.
Slovenian: *Folitropin alfa (rekombinantni humani folikle stimulirajoči hormon [r-hFSH]), pridobljen iz celic jajčnika kitajskega hrčka (CHO DHFR) z uporabo tehnologije rekombinante DNA.
English: • The usual starting dose of this medicine is 75 to 150 IU each day.
Slovenian: • Običajni začetni odmerek tega zdravila je 75 do 150 i.e. vsak dan.
English: • Serious blood clotting complications (thromboembolic events), sometimes independent of OHSS, may be found very rarely (may affect up to 1 in 10,000 people).
Slovenian: • Resni zapleti zaradi krvnih strdkov (trombembolični dogodki), ki so včasih neodvisni od OHSS, so zelo redki (prizadenejo lahko največ 1 od 10.000 bolnic).
English: • Lower stomach ache together with nausea or vomiting may be the symptoms of Ovarian Hyper-Stimulation Syndrome (OHSS).
Slovenian: • Bolečine v spodnjem delu trebuha skupaj s slabostjo ali bruhanjem so lahko simptomi sindroma hiperstimulacije jajčnikov (OHSS).
English: Severe OHSS (including associated symptomatology) (see section 4.4)
Slovenian: občasni hud OHSS (vključno s povezanimi simptomi) (glejte poglavje 4.4)
English: ● At the request of the European Medicines Agency;
Slovenian: Posodobljen RMP je treba predložiti: ● na zahtevo Evropske agencije za zdravila;
English: This medicine usually does not work if you have this problem.
Slovenian: V takih primerih to zdravilo običajno ni učinkovito.
English: • Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene citrate.
Slovenian: • Anovulacija (vključno s sindromom policističnih jajčnikov) pri ženskah, ki se niso odzvale na zdravljenje s klomifen citratom.
English: 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.
Slovenian: Režim, ki se običajno uporablja za superovulacijo, vključuje dajanje 150-225 i.e. folitropina alfa na dan, s pričetkom na 2. ali 3. dan ciklusa.
English: If your doctor cannot see a response after 5 weeks, that treatment cycle should be stopped.
Slovenian: Če vaš zdravnik ne more doseči odziva po 5 tednih zdravljenja, je treba ciklus zdravljenja opustiti.
English: Women undergoing ovarian stimulation for multiple follicular development prior to in vitro fertilisation or other ART
Slovenian: Ženske v postopku stimulacije ovarijev za doseganje razvoja več foliklov pred in vitro oploditvijo ali drugimi ART
English: Non-clinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity and genotoxicity additional to that already stated in other sections of this SmPC.
Slovenian: Predklinični podatki na osnovi običajnih študij toksičnosti pri enkratnih in ponavljajočih odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka, razen že omenjenega v drugih poglavjih tega povzetka glavnih značilnosti zdravila.
English: This medicine is given as an injection into the tissue just under the skin (subcutaneous injection).
Slovenian: To zdravilo se daje kot injekcija v tkivo tik pod kožo (subkutana injekcija).
English: What Ovaleap looks like and contents of the pack Ovaleap is a solution for injection (injection).
Slovenian: Izgled zdravila Ovaleap in vsebina pakiranja Zdravilo Ovaleap je raztopina za injiciranje (injekcije).
English: What you need to know before you use Ovaleap
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Ovaleap
English: Discard used needles immediately after injection.
Slovenian: Uporabljene injekcijske igle zavrzite takoj po injiciranju.
English: • Your dose of Ovaleap may be increased every 7 or every 14 days by 37.5 to 75 IU, until you get the desired response.
Slovenian: • Vaš odmerek zdravila Ovaleap se lahko poveča vsakih 7 ali 14 dni za 37,5 do 75 i.e., dokler ne boste dosegli želenega odziva.
English: There may be a degree of interpatient variability in response to FSH administration, with a poor response to FSH in some patients and exaggerated response in others.
Slovenian: Razpon odziva na zdravljenje s FSH se lahko med bolniki razlikuje, pri nekaterih bolnikih je odziv na FSH zelo majhen in pri drugih pretiran.
English: • The usual starting dose of Ovaleap is 75 to 150 IU together with 75 IU of lutropin alfa.
Slovenian: • Običajni začetni odmerek zdravila Ovaleap je 75 do 150 i.e. skupaj s 75 i.e. lutropina alfa.
English: Patients undergoing stimulation of follicular growth, whether as treatment for anovulatory infertility or ART procedures, may experience ovarian enlargement or develop hyperstimulation.
Slovenian: Pri bolnicah v postopku stimulacije folikularne rasti, bodisi kot zdravljenje anovulacijske neplodnosti ali v postopkih ART, se lahko povečajo jajčniki ali se razvije hiperstimulacija.
English: • primary testicular insufficiency.
Slovenian: • primarna insuficienca testisov
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 prepustnostjo žil, kar lahko rezultira v nabiranju tekočine v trebušni votlini, plevralni votlini in redko v perikardialni votlini.
English: Given in high doses (≥ 5 IU/kg/day) follitropin alfa caused a decrease in the number of viable foetuses without being a teratogen and dystocia similar to that observed with urinary Menopausal Gonadotropin (hMG).
Slovenian: V visokih odmerkih (≥ 5 i.e./kg/dan) je folitropin alfa povzročil zmanjšanje števila živih zarodkov brez teratogenega učinka in distocijo, podobno tisti, ki je bila opažena pri urinarnem menopavznem gonadotropinu (hMG).
English: • Allergic reactions such as skin rash, raised itchy areas of skin and severe allergic reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the face have been reported very rarely (may affect up to 1 in 10,000 people).
Slovenian: • Zelo redko so poročali o alergijskih reakcijah, kot je izpuščaj na koži, izbočeni srbeči predeli kože in hude alergijske reakcije s šibkostjo, padcem krvnega tlaka, težavami z dihanjem in oteklostjo obraza (pojavijo se lahko pri največ 1 od 10.000 bolnikov).
English: Women with a history of tubal disease are at risk of ectopic pregnancy, whether the pregnancy is obtained by spontaneous conception or with fertility treatments.
Slovenian: Pri ženskah z boleznijo jajcevodov v anamnezi obstaja tveganje zunajmaternične nosečnosti, ne glede na to ali pride do zanositve spontano ali z zdravljenjem neplodnosti.
English: In women whose endogenous gonadotropin secretion is suppressed, follitropin alfa has nevertheless been shown to effectively stimulate follicular development and steroidogenesis, despite unmeasurable LH levels.
Slovenian: Pri ženskah z zavrtim izločanjem endogenega gonadotropina pa se je izkazalo, da folitropin alfa učinkovito spodbuja razvoj foliklov in steroidogenezo, kljub nemerljivim ravnem LH.
English: • If you use Ovaleap 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 Ovaleap to produce follicles.
Slovenian: • Če uporabljate zdravilo Ovaleap sočasno z agonisti ali antagonisti "gonadotropin sproščujočega hormona" (GnRH) (ta zdravila zmanjšajo ravni spolnih hormonov in prekinejo ovulacijo), boste morda potrebovali večji odmerek zdravila Ovaleap za tvorbo foliklov.
English: Ovaleap cartridges are not designed to allow any other medicinal product to be mixed in the cartridges.
Slovenian: Vložki zdravila Ovaleap so oblikovani tako, da ne dopuščajo mešanja z drugim zdravilom v vložkih.
English: The solution must not be used if it contains particles or if the solution is not clear.
Slovenian: Raztopine ne uporabljajte, če vsebuje delce ali ni bistra.
English: In clinical trials, patients with severe FSH and LH deficiency were defined by an endogenous serum LH level < 1.2 IU/L as measured in a central laboratory.
Slovenian: V kliničnih študijah so določili bolnice s hudim pomanjkanjem FSH in LH na podlagi serumske ravni endogenega LH < 1,2 i.e./l, izmerjene v centralnem laboratoriju.
English: Ovaleap is intended for subcutaneous use.
Slovenian: Zdravilo Ovaleap je namenjeno za subkutano uporabo.