FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will decide if you can give yourself further doses of this medicine at home, but only after receiving adequate training.
Slovenian: Zdravnik bo odločil, ali si lahko zdravilo dajete sami doma, vendar samo po opravljenem ustreznem usposabljanju.
English: Therefore the AMH result from a blood sample (taken within the last 12 months) should be available before you start treatment.
Slovenian: Zato mora biti rezultat AMH iz vzorca krvi (odvzetega v zadnjih 12 mesecih) na voljo pred začetkom zdravljenja.
English: Why do I have to count to 5 while holding the injection button?
Slovenian: Zakaj moram med držanjem gumba za injiciranje šteti do 5?
English: • Do not store the pen in extreme temperatures, direct sunlight or very cold conditions, such as in a car or freezer.
Slovenian: • Injekcijskega peresnika ne shranjujte pri ekstremnih temperaturah, na neposredni sončni svetlobi ali v zelo hladnih razmerah, kot na primer v avtomobilu ali zamrzovalniku.
English: OHSS may progress rapidly (within 24 hours to several days) to become a serious medical event.
Slovenian: SHSJ se lahko hitro (v 24 urah do nekaj dneh) razvije v resen zdravstven zaplet.
English: It most often occurs after hormonal treatment has been discontinued.
Slovenian: Najpogosteje se pojavi po prekinitvi hormonskega zdravljenja.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 December 2016
Slovenian: Datum prve odobritve: 12. december 2016
English: 0.66 (priming dose)
Slovenian: 0,66 (pripravljalni odmerek)
English: Summary of safety profile
Slovenian: Povzetek profila varnosti
English: Multiple pregnancy may lead to medical complications for you and your babies.
Slovenian: Večplodna nosečnost lahko vodi v zdravstvene zaplete pri vas in vaših otrocih.
English: 2300 Copenhagen S Denmark
Slovenian: 2300 København S
English: Examples of prescribed dose (in micrograms)
Slovenian: Primeri predpisanega odmerka (v mikrogramih)
English: The risk of having a side effect is described by the following categories:
Slovenian: Tveganje za neželene učinke je opisano z naslednjimi kategorijami:
English: Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.
Slovenian: Poškodbe jajčnikov zaradi zmanjšane oskrbe s krvjo je mogoče omejiti z zgodnjo diagnozo in takojšnjo detorzijo.
English: If your body´s response to treatment is too weak or too strong, your doctor may decide to stop treatment with REKOVELLE.
Slovenian: Če je odziv vašega telesa na zdravljenja prešibak ali premočan, se lahko zdravnik odloči za prekinitev zdravljenja z zdravilom REKOVELLE.
English: It must be discarded afterwards.
Slovenian: Zatem ga je treba zavreči.
English: Please contact your doctor as soon as you notice that you forgot a dose.
Slovenian: Zdravnika obvestite takoj, ko opazite, da ste pozabili vzeti odmerek.
English: The first injection should be performed under direct medical supervision.
Slovenian: Prvo injekcijo je treba uporabiti pod neposrednim zdravniškim nadzorom.
English: Page numbers refer to the printed Instructions For Use booklet and not to actual page numbers in this document.
Slovenian: 1 Številke strani se nanašajo na natisnjena navodila za uporabo in ne na dejansko oštevilčenje tega dokumenta.
English: When you feel a light resistance it is safely on.
Slovenian: Ko začutite rahel upor, je varno nameščena.
English: Before starting treatment with this medicine, a doctor should check you and your partner for possible causes of your fertility problems.
Slovenian: Pred začetkom zdravljenja s tem zdravilom mora zdravnik pri vas in vašem partnerju preveriti možne vzroke vaših težav s plodnostjo.
English: • See “Disposal” at Page 181.
Slovenian: • Glejte razdelek »Odstranjevanje« na strani 181.
English: • properly labeled to warn of hazardous waste inside the container.
Slovenian: • je pravilno označena z opozorili o nevarnih odpadkih v posodi.
English: mcg: micrograms
Slovenian: µg: mikrogrami
English: For storage conditions after first use of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po prvi uporabi zdravila glejte poglavje 6.3.
English: Contact
Slovenian: Kontakt
English: Furthermore, the syndrome may be more severe and more protracted if pregnancy occurs.
Slovenian: Prav tako je lahko sindrom hujši in dolgotrajnejši v primeru nosečnosti.
English: (Dial to 11)
Slovenian: (obrnite do 11)
English: The relevance of these findings for the clinical use of REKOVELLE is limited.
Slovenian: Pomen teh ugotovitev za klinično rabo zdravila REKOVELLE je omejen.
English: • upright and stable during use,
Slovenian: • je med uporabo pokončna in stabilna;
English: The patients were up to 40 years of age and had regular menstrual cycles presumed to be ovulatory.
Slovenian: Bolnice so bile stare do 40 let in so imele redne menstrualne cikle z domnevno ovulacijo.
English: EXP After first use: Use within 28 days.
Slovenian: EXP Po prvi uporabi: Uporabite v 28 dneh.
English: Change the needle.
Slovenian: Zamenjajte iglo.
English: • You will hear or feel a click when the needle is safely on.
Slovenian: • Zaslišali boste klik ali začutili, kdaj je igla varno nameščena.
English: Clear and colourless solution with a pH of 6.0-7.0.
Slovenian: Bistra in brezbarvna raztopina z vrednostjo pH 6,0-7,0.
English: D-24109 Kiel Germany
Slovenian: D-24109 Kiel
English: Treatment with gonadotropins may further increase the risk for aggravation or occurrence of such events.
Slovenian: Zdravljenje z gonadotropini lahko še dodatno poveča tveganje za poslabšanje ali pojav tovrstnih dogodkov.
English: Before use - (Step 1)
Slovenian: Pred uporabo - (1. korak)
English: • you have had an early menopause
Slovenian: • če imate zgodnjo menopavzo;
English: For example, if the number in column C is 5.34, round your remaining dose to 5.33.
Slovenian: Če je na primer v stolpcu C vrednost 5,34, svoj preostali odmerek zaokrožite na 5,33.
English: The needles are for single-use only.
Slovenian: Igle so namenjene samo za enkratno uporabo.
English: If the number in column C is 9.67, round your remaining dose to 9.66.
Slovenian: Če je vrednost v stolpcu C 9,67, svoj preostali odmerek zaokrožite na 9,66.
English: What REKOVELLE is and what it is used for 2.
Slovenian: Kaj je zdravilo REKOVELLE in za kaj ga uporabljamo 2.
English: If you do not have a sharps disposal container, you may use a household container that is:
Slovenian: Če nimate posode za odstranjevanje ostrih predmetov, lahko uporabite gospodinjsko posodo, ki:
English: The dose should be based on a recent determination of AMH (i.e. within the last 12 months) measured by the following diagnostic test from Roche: ELECSYS AMH Plus immunoassay (see section 4.4).
Slovenian: Odmerek mora temeljiti na nedavno določeni vrednosti AMH (tj. v zadnjih 12 mesecih), izmerjene s sledečim diagnostičnim testom družbe Roche: imunski test ELECSYS AMH Plus (glejte poglavje 4.4).
English: There may be state or local laws about how you should throw away used needles.
Slovenian: Državni ali lokalni zakoni morda določajo, kako je treba uporabljene igle zavreči med odpadke.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z zdravili brez recepta.
English: • have difficulty in breathing
Slovenian: • če težko dihate.
English: • If a broken needle remains stuck in the body or remains under the skin, get medical help right away.
Slovenian: • Če zlomljena igla ostane v telesu ali pod kožo, nemudoma poiščite zdravniško pomoč.
English: Frequently Asked Questions (FAQ)
Slovenian: Pogosto zastavljena vprašanja
English: Safety - immunogenicity
Slovenian: Varnost - imunogenost
English: After first use: Use within 28 days.
Slovenian: Po prvi uporabi: Uporabite v 28 dneh.
English: The first injection of this medicine should be given under the supervision of a doctor or a nurse.
Slovenian: Prvo injekcijo tega zdravila boste prejeli pod nadzorom zdravnika ali medicinske sestre.
English: Although limited, data did not indicate a need for a different dosing regimen of REKOVELLE in this patient population (see section 4.4).
Slovenian: Podatki, čeprav omejeni, niso pokazali potrebe po drugačnem režimu odmerjanja zdravila REKOVELLE pri tej populaciji bolnic (glejte poglavje 4.4).
English: In all patients with anti-FSH antibodies, titres were undetectable or very low and without neutralising capacity.
Slovenian: Pri vseh bolnicah s protitelesi proti FSH so bili titri nezaznavni ali zelo nizki in brez sposobnosti nevtraliziranja.
English: • you have been told by another doctor that pregnancy would be dangerous for you
Slovenian: • če vam je kateri drug zdravnik odsvetoval nosečnost kot nevarno za vas,
English: • you suffer from bleeding from the vagina without any known cause
Slovenian: • če imate krvavitev iz nožnice brez znanega vzroka;
English: The most important effect resulting from parenteral administration of FSH is the development of multiple mature follicles.
Slovenian: Najpomembnejši učinek parenteralne uporabe FSH je razvoj več zrelih foliklov.
English: • Doses should be rounded off to nearest increment, X.00, X.33 or X.66 micrograms.
Slovenian: • Odmerke je treba zaokrožiti na najbližji korak, tj. X,00, X,33 ali X,66 mikrogramov.
English: Single blastocyst transfer on day 5 was compulsory with the exception of patients 38-40 years in whom double blastocyst transfer was performed if no good-quality blastocysts were available.
Slovenian: Na peti dan je bil obvezen prenos ene blastociste, z izjemo bolnic, starih 38-40 let, pri katerih so izvedli prenos dveh blastocist, če ni bilo na voljo blastocist dobre kakovosti.
English: • You may also screw on the needle.
Slovenian: • Iglo lahko tudi privijete.
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Slovenian: Zdravljenje je treba uvesti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem težav s plodnostjo.
English: Do not touch the injection button yet.
Slovenian: Gumba za injiciranje se še ne dotikajte.
English: If the patient had adequate ovarian response in the previous cycle without developing OHSS, the same daily dose should be used.
Slovenian: Če je imela bolnica v prejšnjem ciklu zadosten odziv jajčnikov, ne da bi se razvil SHSJ, je treba uporabljati enak dnevni odmerek.
English: The maximum daily dose for the first treatment cycle is 12 micrograms.
Slovenian: Največji dnevni odmerek za prvi cikel zdravljenja je 12 mikrogramov.
English: In these women, the benefits of gonadotropin administration need to be weighed against the risks.
Slovenian: Pri teh ženskah je treba pretehtati koristi uporabe gonadotropinov glede na tveganja.
English: For calculation of the REKOVELLE dose, the body weight is to be measured without shoes and overcoat just prior to start of stimulation.
Slovenian: Pri izračunu odmerka zdravila REKOVELLE je treba telesno maso izmeriti brez čevljev in vrhnjih oblačil neposredno pred začetkom spodbujanja.
English: It should be noted however that pregnancy itself as well as OHSS also carry an increased risk of thromboembolic events.
Slovenian: Vendar moramo upoštevati, da tudi sama nosečnost in SHSJ povečujeta tveganje za trombembolične dogodke.
English: • Read Step 11 and 12 at Page 14 to 151 before giving your injection.
Slovenian: • Pred injiciranjem preberite 11. in 12. korak na straneh 14 do 151.
English: • The REKOVELLE pre-filled pen and the needles are for use by only one person and should not be shared with others.
Slovenian: • Napolnjen injekcijski peresnik REKOVELLE in igle lahko uporablja samo ena oseba in ga ne sme deliti z drugimi ljudmi.
English: How are injections given
Slovenian: Kako dajati injekcije
English: The AMH concentration is to be expressed in pmol/L and is to be rounded off to the nearest integer.
Slovenian: Vrednost AMH mora biti izražena v pmol/l in zaokrožena na najbližje celo število.
English: • The number ‘0' is lined up with the dose indicator.
Slovenian: • Število »0« je poravnano s kazalnikom odmerka.
English: This is when your follicles develop too much and become large cysts.
Slovenian: To pomeni, da se folikli prekomerno razvijejo in postanejo velike ciste.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital systems, gonadotropins, ATC code: G03GA10
Slovenian: Farmakoterapevtska skupina: spolni hormoni in zdravila za uravnavanje delovanja spolovil, gonadotropni hormoni, oznaka ATC: G03GA10
English: What you need to know before you use REKOVELLE 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo REKOVELLE 3.
English: Your doctor will monitor the effect of REKOVELLE treatment, and treatment is stopped when an appropriate number of egg sacs are present.
Slovenian: Zdravnik bo spremljal učinek zdravljenja z zdravilom REKOVELLE in ga prekinil, ko bo prisotno ustrezno število jajčnih mešičkov.
English: Conversely, increasing body weight leads to a decrease in the number of oocytes retrieved (only clinically relevant for REKOVELLE doses below 12 micrograms).
Slovenian: Obratno pa povečanje telesne mase povzroči zmanjšanje števila pridobljenih oocitov (to je klinično pomembno samo za odmerke zdravila REKOVELLE, manjše od 12 mikrogramov).
English: Twisting of the ovary could cut off the blood flow to the ovary.
Slovenian: Zasuk jajčnikov lahko prekine dotok krvi do jajčnikov.
English: Follitropin delta is expected to be eliminated similarly to other follitropins, i.e. mainly by the kidneys.
Slovenian: Za folitropin delta se pričakuje, da se bo izločal podobno kot drugi folitropini, tj. predvsem skozi ledvice.
English: Then slowly remove the needle from the injection site by pulling it straight out of the skin.
Slovenian: Nato počasi odstranite iglo z mesta injiciranja tako, da jo naravnost izvlečete iz kože.
English: Because of the risk of developing OHSS patients should be followed for at least two weeks after triggering of final follicular maturation.
Slovenian: Zaradi tveganja za razvoj SHSJ je treba bolnice spremljati še vsaj dva tedna po sprožitvi končnega zorenja foliklov.
English: Follitropin delta is a recombinant human FSH.
Slovenian: Folitropin delta je rekombinantni humani FSH.
English: In particular, patients should be evaluated for hypothyroidism and hyperprolactinemia, and the appropriate specific treatment should be given.
Slovenian: Bolnice je treba pregledati zlasti glede hipotiroidizma in hiperprolaktinemije ter jim zagotoviti ustrezno specifično zdravljenje.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Slovenian: • preobčutljivost za zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1
English: The REKOVELLE dose is fixed for the whole treatment period with no adjustments to increase or decrease your daily dose.
Slovenian: Odmerek zdravila REKOVELLE je stalen v celotnem obdobju zdravljenja, brez povečevanja ali zmanjševanja vašega dnevnega odmerka.
English: Your doctor may ask you to stop using this medicine (see section 4).
Slovenian: Zdravnik vam lahko odsvetuje nadaljnjo uporabo tega zdravila (glejte poglavje 4).
English: The fraction of follitropin delta excreted unchanged in the urine was estimated to 9%.
Slovenian: Frakcija folitropina delta, izločenega z urinom v nespremenjeni obliki, je bila ocenjena na 9 %.
English: Studies in animals have shown reproductive toxicity with REKOVELLE doses above the recommended maximal dose in humans (section 5.3).
Slovenian: Študije na živalih so pokazale reproduktivno toksičnost odmerkov zdravila REKOVELLE, ki so bili večji od priporočenih največjih odmerkov za ljudi (poglavje 5.3).
English: Follow the instructions carefully even if you have used a similar injection pen before.
Slovenian: Natančno preberite navodila, četudi ste že uporabljali podoben injekcijski peresnik.
English: When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.
Slovenian: Ko je posoda za odstranjevanje ostrih predmetov skoraj polna, morate upoštevati lokalne smernice za pravilno odstranjevanje posode za odstranjevanje ostrih predmetov med odpadke.
English: What if the dose knob cannot be turned to the required dose?
Slovenian: Kaj naj storim, če gumba za odmerjanje ni mogoče obrniti do želenega odmerka?
English: Therefore, in cases of ovarian hyperstimulation it is prudent to withhold hCG and advise the patient to refrain from coitus or to use barrier contraceptive methods for at least 4 days.
Slovenian: Zato je smiselno, da se v primeru hiperstimulacije jajčnikov hCG ne uporabi, bolnici pa se svetuje vzdržnost od spolnih odnosov ali uporaba barierne metode kontracepcije najmanj štiri dni.
English: Other medicines and REKOVELLE
Slovenian: Druga zdravila in zdravilo REKOVELLE
English: A certain degree of ovarian enlargement is an expected effect of controlled ovarian stimulation.
Slovenian: Določena stopnja povečanja jajčnikov je pričakovani učinek nadzorovanega spodbujanja jajčnikov.
English: The maximum daily dose is 24 micrograms.
Slovenian: Največji dnevni odmerek znaša 24 mikrogramov.
English: Gonadotropin therapy requires time commitment by physicians and supportive healthcare professionals, as well as the availability of appropriate monitoring facilities.
Slovenian: Zdravljenje z gonadotropinom zahteva od zdravnika in zdravstvenega osebja čas ter razpoložljivost ustrezne opreme za spremljanje zdravljenja.
English: Ovarian hyperstimulation syndrome may possibly occur, which is described in section 4.
Slovenian: Lahko se pojavi sindrom hiperstimulacije jajčnikov, ki je opisan v poglavju 4.
English: • The dose scale of the pen is numbered from 0 to 20 micrograms.
Slovenian: • Velikosti odmerka injekcijskega peresnika so oštevilčene od 0 do 20 mikrogramov.
English: Before first use, store in the original package in order to protect from light.
Slovenian: Pred prvo uporabo shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: For the next treatment cycle, your doctor will in this case give you either a higher or a lower daily dose of REKOVELLE than before.
Slovenian: V tem primeru vam bo za naslednji cikel zdravljenja zdravnik dal večji ali manjši dnevni odmerek zdravila REKOVELLE kot prej.
English: The dosing regimen is specific for REKOVELLE and the microgram dose cannot be applied to other gonadotropins.
Slovenian: Režim odmerjanja je specifičen za zdravilo REKOVELLE in odmerek v mikrogramih ne velja za druge gonadotropine.
English: Infertility treatment can increase the risk of this happening, especially if you are overweight or you or someone in your family (blood relative) have a known blood clotting disease (thrombophilia).
Slovenian: Zdravljenje neplodnosti lahko poveča tovrstno tveganje, zlasti če imate prekomerno telesno maso ali če vi ali član vaše družine (krvni sorodnik) trpi za znano boleznijo strjevanja krvi (trombofilijo).
English: The incidence of anti-FSH antibodies after treatment with REKOVELLE was 1.1% in cycle 1, 0.8% in cycle 2 and 1.1% in cycle 3.
Slovenian: Pojavnost protiteles proti FSH je bila po zdravljenju z zdravilom REKOVELLE 1,1 % v 1. ciklu, 0,8 % v 2. ciklu in 1,1 % v 3. ciklu.
English: In distinction to uncomplicated ovarian enlargement, OHSS is a condition that can manifest itself with increasing degrees of severity.
Slovenian: Za razliko od povečanja jajčnikov brez zapletov je SHSJ stanje, ki se lahko izrazi z naraščajočo stopnjo resnosti.
English: Do not use this medicine if you are pregnant or breast-feeding.
Slovenian: Nosečnost in dojenje Ne uporabljajte tega zdravila, če ste noseči ali dojite.
English: • Use the pen only for the medical condition it is prescribed for and as directed by your healthcare provider.
Slovenian: • Injekcijski peresnik uporabljajte samo za zdravstveno stanje, za katerega je predpisan in po navodilih vašega zdravstvenega delavca.
English: Follitropin delta leads to greater exposure than follitropin alfa.
Slovenian: Folitropin delta vodi k večji izpostavljenosti kot folitropin alfa.
English: The number of oocytes retrieved increases with the dose of REKOVELLE and serum AMH concentration.
Slovenian: Število pridobljenih oocitov se povečuje z odmerkom zdravila REKOVELLE in serumsko koncentracijo AMH.
English: • Sleepiness/drowsiness
Slovenian: • zaspanost/dremavost,
English: Treatment with REKOVELLE should be initiated day 2 or 3 after start of menstrual bleeding, and continue until adequate follicular development (≥3 follicles ≥17 mm) has been achieved, which on average is by the ninth day of treatment (range 5 to 20 days).
Slovenian: Zdravljenje z zdravilom REKOVELLE je treba uvesti drugi ali tretji dan po začetku menstrualne krvavitve in z njim nadaljevati, dokler ni dosežen zadosten razvoj foliklov (≥ 3 folikli ≥ 17 mm), kar v povprečju traja do devetega dne zdravljenja (razpon od 5 do 20 dni).
English: The terminal elimination half-life after single subcutaneous administration is 40 hours and after multiple subcutaneous administration is 28 hours.
Slovenian: Končni razpolovni čas izločanja po enkratnem subkutanem odmerku je 40 ur in po večkratnih subkutanih odmerkih 28 ur.
English: Before starting to use this medicine, tell your doctor if:
Slovenian: Pred začetkom zdravljenja s tem zdravilom obvestite svojega zdravnika:
English: For women with AMH <15 pmol/L the daily dose is 12 micrograms, irrespective of body weight.
Slovenian: Pri ženskah z vrednostjo AMH < 15 pmol/l je dnevni odmerek 12 mikrogramov ne glede na telesno maso.
English: Safe and effective use of REKOVELLE calls for monitoring of ovarian response with ultrasound alone, or in combination with measurement of serum estradiol levels, on a regular basis.
Slovenian: Za varno in učinkovito uporabo zdravila REKOVELLE je potrebno redno spremljanje odziva jajčnikov, ali samo z ultrazvokom ali v kombinaciji z merjenjem serumskih vrednosti estradiola.
English: Immunogenicity in terms of development of anti-FSH antibodies is a potential risk of gonadotropin therapy (see section 5.1).
Slovenian: Imunogenost v smislu razvoja protiteles proti FSH je potencialno tveganje pri zdravljenju z gonadotropinom (glejte poglavje 5.1)
English: At the end of the treatment any unused solution must be discarded.
Slovenian: Po končanem zdravljenju je treba neuporabljeno raztopino zavreči.
English: Because follitropin delta is produced in the human cell line PER.C6, the glycosylation profile is different from follitropin alfa and follitropin beta.
Slovenian: Ker se folitropin delta pridobiva iz človeške celične linije PER.C6, se profila glikozilacije folitropina alfa in folitropina beta razlikujeta.
English: It is more commonly seen in patients with polycystic ovarian syndrome and usually regresses without treatment.
Slovenian: Pogosteje nastopi pri bolnicah s sindromom policističnih jajčnikov in navadno izzveni brez zdravljenja.
English: Store in refrigerator (2 °C - 8 °C).
Slovenian: Shranjujte v hladilniku (2 °C - 8 °C).
English: These rates were similar to the incidence of pre-existing anti-FSH antibodies before exposure to REKOVELLE in cycle 1 which was 1.4%, and comparable to the incidences of anti-FSH antibodies after treatment with follitropin alfa.
Slovenian: Te vrednosti so bile podobne pojavnosti predhodno prisotnih protiteles proti FSH pred izpostavljenostjo zdravilu REKOVELLE v 1. ciklu, ki je znašala 1,4 %, in primerljive s pojavnostjo protiteles proti FSH po zdravljenju s folitropinom alfa.
English: Children and adolescents (under 18 years of age)
Slovenian: Otroci in mladostniki (mlajši od 18 let) To zdravilo se ne uporablja pri otrocih in mladostnikih.
English: Step 11 and 12:
Slovenian: 11. in 12. korak:
English: Follitropin delta had a negative effect on fertility and early embryonic development in rats when administered in doses ≥0.8 micrograms/kg/day which is above the recommended maximal dose in humans.
Slovenian: Folitropin delta je imel negativen vpliv na plodnost in zgodnji embrionalni razvoj pri podganah v odmerkih ≥ 0,8 mikrograma/kg/dan, kar presega priporočeni največji odmerek za ljudi.