FrancophonIA/ELRC3.0 huggingface dataset:
English: • in combination with a medicine called “human chorionic gonadotropin” (hCG) to help produce sperm in men that are infertile due to low levels of certain hormones.
Slovenian: • v kombinaciji z zdravilom "humani horionski gonadotropin" (hCG) za pomoč pri tvorbi sperme pri moških, ki so neplodni zaradi nizke ravni nekaterih hormonov.
English: Ovarian Hyperstimulation Syndrome (OHSS)
Slovenian: Sindrom hiperstimulacije jajčnikov (OHSS, Ovarian Hyperstimulation Syndrome)
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 hCG. Follitropin alfa should be given as a course of daily injections simultaneously with lutropin alfa.
Slovenian: Ženske z anovulacijo zaradi hudega pomanjkanja LH in FSH 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 hCG. Folitropin alfa se mora dajati kot zaporedje vsakodnevnih injekcij sočasno z lutropinom alfa.
English: In adult women, Ovaleap is used:
Slovenian: Pri odraslih ženskah se zdravilo Ovaleap uporablja:
English: The prevalence of ectopic pregnancy after ART, was reported to be higher than in the general population.
Slovenian: Poročali so o višji prevalenci zunajmaternične nosečnosti po ART kot pri splošni populaciji.
English: Before opening and within its shelf life, the medicinal product may be removed from the refrigerator, without being refrigerated again, for up to 3 months.
Slovenian: Pred odprtjem in v času roka uporabnosti se lahko zdravilo vzame iz hladilnika in se shranjuje zunaj njega do 3 mesece.
English: • primary ovarian failure;
Slovenian: • primarna odpoved jajčnikov
English: • to help ovulation (release of a mature egg cell from the follicle) in women that cannot ovulate and that have not responded to treatment with a medicine called “clomifene citrate”.
Slovenian: • za pomoč pri ovulaciji (sproščanje zrelih jajčnih celic iz folikla) pri ženskah, ki nimajo ovulacije in se ne odzivajo na zdravljenje z zdravilom, ki vsebuje "klomifen citrat";
English: Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and oestrogen response.
Slovenian: Zdravljenje mora biti prilagojeno odzivu posamezne bolnice, ki se oceni z merjenjem velikosti folikla z ultrazvokom in estrogenskim odzivom.
English: Following repeated administration, follitropin alfa accumulates 3-fold achieving a steady-state within 3-4 days.
Slovenian: Po večkratnem dajanju, doseže folitropin alfa trikratno raven v plazmi in doseže stanje dinamičnega ravnovesja v 3 do 4 dneh.
English: Teva Biotech GmbH Dornierstraße 10 D-89079 Ulm Germany
Slovenian: Teva Biotech GmbH Dornierstraße 10 D-89079 Ulm Nemčija
English: Treatment is continued until adequate follicular development has been achieved (as assessed by monitoring of serum oestrogen concentrations and/or ultrasound examination), with the dose adjusted according to the patient's response, to usually not higher than 450 IU daily.
Slovenian: Zdravljenje se nadaljuje, dokler ni dosežen zadosten folikularni razvoj (kar se oceni s spremljanjem serumske koncentracije estrogena in/ali ultrazvočnim pregledom), tako da se odmerek prilagaja odzivu bolnice in običajno ni večji od 450 i.e. na dan. Na splošno je zadosten folikularni razvoj v povprečju dosežen do desetega dneva zdravljenja (razpon 5 do 20 dni).
English: • Local reactions at the injection site, such as pain, redness, bruising, swelling and/or irritation
Slovenian: • lokalne reakcije na mestu injiciranja kot so bolečina, pordelost, modrice, oteklina in/ali draženje
English: In clinical trials, an increase of the ovarian sensitivity to follitropin alfa was shown when administered with lutropin alfa.
Slovenian: V kliničnih študijah se je pokazalo, da se poveča občutljivost jajčnikov za folitropin alfa, kadar se uporablja skupaj z lutropinom alfa.
English: • Complications of OHSS such as twisting of ovaries or blood clotting may occur rarely (may affect up to 1 in 1,000 people).
Slovenian: • Zapleti OHSS, kot je torzija jajčnikov ali nastajanje krvnih strdkov, se pojavijo redko (prizadenejo lahko največ 1 od 1.000 bolnic).
English: Number of oocytes retrieved Days of FSH stimulation required Total dose of FSH required (number of FSH 75 IU ampoules) Need to increase the dose (%)
Slovenian: Skupni odmerek potrebnega FSH (število ampul FSH 75 i.e.) Potreba po zvišanju odmerka (%)
English: EXP The cartridge in-use in the pen may be stored for a maximum of 28 days not above 25 °C.
Slovenian: EXP Vložek v injekcijskem peresniku lahko shranjujete največ 28 dni pri temperaturi do 25 °C.
English: Other medicines and Ovaleap Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: Ovaleap is a biosimilar medicinal product.
Slovenian: Zdravilo Ovaleap je podobno biološko zdravilo.
English: Mild to severe hypersensitivity reactions, including anaphylactic reactions and shock
Slovenian: Bolezni imunskega sistema zelo redki blage do hude preobčutljivostne reakcije, vključno z anafilaktičnimi reakcijami in šokom
English: Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events such as pulmonary embolism, ischaemic stroke or myocardial infarction.
Slovenian: Pri hudem OHSS je lahko zelo redek zaplet tudi torzija jajčnikov ali trombembolični dogodki kot so pljučni embolizem, ishemični cerebrovaskularni insult ali miokardni infarkt.
English: Do not use this medicine after the expiry date which is stated on the label and outer carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in zunanji ovojnini poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: The Ovaleap Pen is a device (a “pen”) used for giving injections into the tissue just under the skin.
Slovenian: Injekcijski peresnik Ovaleap Pen je pripomoček ("peresnik") za dajanje injekcij v tkivo tik pod kožo.
English: The pen cap must be put back on the pen after each injection in order to protect from light.
Slovenian: Pokrov peresnika je treba po vsakem injiciranju dati nazaj na peresnik za zagotovitev zaščite pred svetlobo.
English: The dose recommendations given for follitropin alfa are those in use for urinary FSH.
Slovenian: Priporočeni odmerek za folitropin alfa je enak kot za urinarni FSH.
English: • Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer.
Slovenian: • Spodbujanje razvoja več foliklov pri ženskah, pri katerih je potrebno izzvati superovulacijo v postopkih asistirane reprodukcije (ART, assisted reproductive technology), kot so in vitro oploditev (IVF), prenos gamete v jajcevod in prenos zigote v jajcevod.
English: Manufacturer Teva Biotech GmbH Dornierstraße 10 89079 Ulm Germany
Slovenian: Izdelovalec Teva Biotech GmbH Dornierstraße 10 89079 Ulm Nemčija
English: CLINICAL PARTICULARS 4.1 Therapeutic indications In adult women
Slovenian: 4.1 Terapevtske indikacije
English: What Ovaleap contains - The active substance is follitropin alfa.
Slovenian: Kaj vsebuje zdravilo Ovaleap - Učinkovina je folitropin alfa.
English: Ovaleap treatment seldom causes severe OHSS unless the medicine that is used for final follicular maturation (containing human chorionic gonadotropin, hCG) is given.
Slovenian: Zdravljenje z zdravilom Ovaleap redko povzroči hud sindrom hiperstimulacije jajčnikov, razen če se daje zdravilo, ki se uporablja za spodbuditev končnega folikularnega zorenja (vsebuje humani horionski gonadotropin hCG).
English: If your doctor cannot see a desired response after 4 weeks, that treatment cycle with Ovaleap should be stopped.
Slovenian: Če vaš zdravnik ne more doseči ustreznega odziva po 4 tednih zdravljenja, je treba ciklus zdravljenja z zdravilom Ovaleap opustiti.
English: The following symptomatology may be observed in severe cases of OHSS: abdominal pain, abdominal distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea.
Slovenian: V hudih primerih OHSS je možno opaziti naslednje znake: bolečine v trebuhu, povečanje trebuha, hudo povečanje jajčnikov, pridobivanje telesne mase, dispneo, oligurijo in gastrointestinalne znake vključno s slabostjo bruhanjem in drisko.
English: • Ovaleap in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency.
Slovenian: • Zdravilo Ovaleap se priporoča skupaj z luteinizirajočim hormonom (LH) za spodbujanje razvoja foliklov pri ženskah s hudim pomanjkanjem LH in FSH.
English: • if you have a tumour in your hypothalamus or pituitary gland (parts of the brain).
Slovenian: • če imate tumor hipotalamusa ali hipofize (dela možganov).
English: • Local reactions at the injection site, such as pain, redness, bruising, swelling and/or irritation Common (may affect up to 1 in 10 people)
Slovenian: • lokalne reakcije na mestu injiciranja kot so bolečina, pordelost, modrice, oteklina in/ali draženje Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov)
English: - The other ingredients are sodium dihydrogen phosphate dihydrate, sodium hydroxide (2 M) (for pH adjustment), mannitol, methionine, polysorbate 20, benzyl alcohol, benzalkonium chloride and water for injections.
Slovenian: - Druge sestavine zdravila so natrijev dihidrogenfosfat dihidrat, natrijev hidroksid (2 M) (za uravnavanje pH), manitol, metionin, polisorbat 20, benzilalkohol, benzalkonijev klorid in voda za injekcije.
English: Do not use this medicine if you notice it is cloudy or there are particles in it. Do not throw away any medicines via wastewater.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da je raztopina motna ali da so v njej delci.
English: In adult men, Ovaleap is used:
Slovenian: Pri odraslih moških se zdravilo Ovaleap uporablja:
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: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: V razvrstitvah pogostnosti so neželeni učinki razvrščeni po padajoči resnosti Zdravljenje žensk
English: However, the OHSS will only occur if hCG is also administered [see also section 2 under “Ovarian Hyper-Stimulation Syndrome (OHSS)”].
Slovenian: OHSS pa se lahko pojavi samo, če se uporabi tudi hCG [glejte tudi poglavje 2 "Sindrom hiperstimulacije jajčnikov (OHSS)"].
English: • When you get the desired response, you will be given hCG or r-hCG.
Slovenian: • Ko boste dosegli želeni odziv, boste prejeli hCG ali r-hCG. Ena injekcija bo vsebovala
English: In women with anovulation, the object of follitropin alfa therapy is to develop a single mature Graafian follicle from which the ovum will be liberated after the administration of hCG.
Slovenian: Pri ženskah z anovulacijo je cilj zdravljenja s folitropinom alfa razvoj enega zrelega Graafovega folikla, iz katerega se bo po dajanju hCG sprostilo jajčece.
English: This medicine is given as an injection into the tissue just under the skin (subcutaneous injection) using the Ovaleap Pen.
Slovenian: To zdravilo se daje kot injekcija v tkivo tik pod kožo (subkutana injekcija) z uporabo injekcijskega peresnika Ovaleap Pen.
English: Excipients: sodium dihydrogen phosphate dihydrate, sodium hydroxide (2 M) (for pH adjustment), mannitol, methionine, polysorbate 20, benzyl alcohol, benzalkonium chloride, water for injections.
Slovenian: Pomožne snovi: natrijev dihidrogenfosfat dihidrat, natrijev hidroksid (2 M) (za uravnavanje pH), manitol, metionin, polisorbat 20, benzilalkohol, benzalkonijev klorid, voda za injekcije.
English: Ovaleap solution for injection in cartridges has been developed for use in the Ovaleap Pen.
Slovenian: Zdravilo Ovaleap raztopina za injiciranje v vložkih je bilo razvito za uporabo v injekcijskih peresnikih Ovaleap Pen.
English: Concomitant use of follitropin alfa with other medicinal products used to stimulate ovulation (e.g. hCG, clomifene citrate) may potentiate the follicular response, whereas concurrent use of a GnRH agonist or antagonist to induce pituitary desensitisation may increase the dose of follitropin alfa needed to elicit an adequate ovarian response.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Sočasna uporaba folitropina alfa z drugimi zdravili, ki se uporabljajo za stimulacijo ovulacije (npr. hCG, klomifen citrat) lahko potencira folikularani odziv, medtem ko sočasna uporaba agonista ali antagonista GnRH za sprožitev desenzitizacije hipofize lahko poveča odmerek folitropina alfa, ki je potreben za dosego ustreznega odziva jajčnikov.
English: Monitoring of stimulation cycles by ultrasound scans as well as oestradiol 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: Sodium content Ovaleap contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodiumfree”.
Slovenian: Zdravilo Ovaleap vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni 'brez natrija'.
English: May be stored before opening not above 25 °C for up to 3 months.
Slovenian: Pred uporabo se lahko zdravilo shranjuje 3 mesece pri temperaturi do 25 °C.
English: The incidence of pregnancy loss by miscarriage or abortion is higher in patients undergoing stimulation of follicular growth for ovulation induction or ART than following natural conception.
Slovenian: Izguba nosečnosti zaradi spontanega splava ali abortusa je pri bolnicah, ki so vključene v postopke stimulacije folikularne rasti za indukcijo ovarijev ali tehnike asistirane reprodukcije, višja kot pri normalni zanositvi.
English: The Ovaleap cartridge is designed for use in conjunction with the Ovaleap Pen only, which is separately available.
Slovenian: Vložek zdravila Ovaleap je zasnovan samo za uporabo v povezavi z injekcijskim peresnikom Ovaleap Pen, ki je na voljo ločeno.
English: Ovaleap is not indicated during breast-feeding.
Slovenian: Zdravilo Ovaleap ni indicirano v obdobju dojenja.
English: There is no relevant use of follitropin alfa in the paediatric population.
Slovenian: Pediatrična populacija Folitropin alfa ni namenjen za uporabo pri pediatrični populaciji.
English: • If you use Ovaleap with other medicines which help ovulation such as human chorionic gonadotropin (hCG) or clomifene citrate, this may increase the response of your follicles.
Slovenian: • Sočasna uporaba zdravila Ovaleap z drugimi zdravili za stimuliranje ovulacije, kot sta humani horionski gonadotropin (hCG) ali klomifen citrat, lahko poveča folikularni odziv.
English: Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and/or oestrogen secretion.
Slovenian: Zdravljenje mora biti prilagojeno odzivu posamezne bolnice in se oceni z merjenjem velikosti folikla z ultrazvokom in/ali merjenjem izločanja estrogena.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of the solution contains 600 IU (equivalent to 44 micrograms) follitropin alfa*.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml raztopine vsebuje 600 i.e. (kar ustreza 44 mikrogramom) folitropina alfa*.
English: Other side effects in women
Slovenian: Drugi neželeni učinki pri ženskah
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja pogosti akne
English: Benzalkonium chloride
Slovenian: Vsebnost benzalkonijevega klorida
English: For the following cycle, your doctor will give you a lower dose of Ovaleap than before.
Slovenian: Za naslednji ciklus vam bo vaš zdravnik dal manjši odmerek zdravila Ovaleap kot v predhodnem ciklusu.
English: • to help follicles develop 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 foliklov pri ženskah v postopkih asistirane reprodukcije (postopek, ki lahko pomaga pri zanositvi) kot so "oploditev in vitro", "prenos gamete v jajcevod" ali "prenos zigote v jajcevod".
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 tehnik asistirane reprodukcije je v glavnem povezano s številom vsajenih embrijev, njihovo kakovostjo in starostjo bolnice.
English: This may indicate that the ovaries over-reacted to the treatment and that large ovarian cysts developed [see also section 2 under “Ovarian Hyper-Stimulation Syndrome (OHSS)”].
Slovenian: Lahko kažejo na to, da so se jajčniki premočno odzvali na zdravljenje in so se razvile velike ciste na jajčnikih (glejte tudi poglavje 2 "Sindrom hiperstimulacije jajčnikov (OHSS)").
English: Write down the date of first use in the patient diary, which will be provided with the Ovaleap Pen.
Slovenian: Prvi datum uporabe zabeležite v bolnikov dnevnik, ki ga boste prejeli skupaj z injekcijskim peresnikom Ovaleap Pen.
English: This side effect is uncommon (may affect up to 1 in 100 people).
Slovenian: Ta neželeni učinek je občasen (prizadene lahko največ 1 od 100 bolnic).
English: Thromboembolism (both in association with and separate from OHSS)
Slovenian: Žilne bolezni zelo redki trombembolizem (tako v povezavi z OHSS in nepovezano z njim)
English: METHOD AND ROUTE(S) OF ADMINISTRATION For use only with the Ovaleap Pen.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Samo za uporabo z injekcijskim peresnikom Ovaleap Pen.
English: If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7-14 day intervals and preferably by 37.5-75 IU increments.
Slovenian: Če se presodi, da je povečanje odmerka FSH primerno, se mora odmerek prilagajati najbolje po 7-14 dnevnih intervalih in najbolje v korakih po 37,5 do 75 i.e.
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 zdravili.
English: What Ovaleap is and what it is used for
Slovenian: Kaj je zdravilo Ovaleap in za kaj ga uporabljamo
English: Put the pen cap back on the Ovaleap Pen after each injection in order to protect the cartridge from light.
Slovenian: Po vsakem injiciranju namestite pokrovček nazaj na injekcijski peresnik Ovaleap Pen za zagotovitev zaščite vložka pred svetlobo.
English: Ovaleap is a clear and colourless solution.
Slovenian: Zdravilo Ovaleap je bistra in brezbarvna tekočina.
English: High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment as well as in pregnant women or while breast-feeding, because of the risk of accumulation and toxicity (metabolic acidosis).
Slovenian: Zaradi možnega kopičenja in toksičnosti (metabolična acidoza) se morajo veliki volumni uporabljati previdno in samo, če je nujno potrebno, posebno pri posameznikih z okvarjenim delovanjem jeter ali ledvic in pri nosečnicah ali med dojenjem.
English: INFORMATION IN BRAILLE Ovaleap 450 IU/0.75 mL
Slovenian: PODATKI V BRAILLOVI PISAVI Ovaleap 450 i.e./0,75 ml
English: Injection needles (stainless steel; 0.33 mm x 12 mm, 29 G x ½") Pack size of 1 cartridge and 20 injection needles.
Slovenian: Injekcijske igle (nerjavno jeklo: 0,33 mm x 12 mm, 29 G x ½").
English: Adherence to 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 minimum ob upoštevanju priporočenega odmerka in režima dajanja folitropina alfa ter ob skrbnem nadzorovanju zdravljenja.
English: The patient should write down in the patient diary provided with the Ovaleap Pen the date of first use.
Slovenian: V bolnikov dnevnik, ki ga prejme z injekcijskim peresnikom Ovaleap Pen, naj bolnik zabeleži datum prve uporabe.
English: Following intravenous administration, follitropin alfa is distributed to the extracellular fluid space with an initial half-life of around 2 hours and 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 2 uri in izloči iz telesa s končnim razpolovnim časom približno en dan. Volumen porazdelitve v stanju dinamičnega ravnovesja je 10 l in celokupni očistek je 0,6 l/h.
English: If you are a woman, this medicine increases your risk of developing OHSS.
Slovenian: Sindrom hiperstimulacije jajčnikov (OHSS, Ovarian Hyper-Stimulation Syndrome) Če ste ženska, to zdravilo povečuje vaše tveganje za razvoj sindroma hiperstimulacije jajčnikov.
English: Sodium dihydrogen phosphate dihydrate Sodium hydroxide (2 M) (for pH adjustment) Mannitol
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev dihidrogenfosfat dihidrat natrijev hidroksid (2 M) (za uravnavanje pH)
English: INFORMATION IN BRAILLE Ovaleap 300 IU/0.5 mL
Slovenian: PODATKI V BRAILLOVI PISAVI Ovaleap 300 i.e./0,5 ml
English: • tumours of the hypothalamus or pituitary gland;
Slovenian: • tumorji hipotalamusa ali hipofize
English: The Ovaleap and GnRH agonist are then both given until your follicles develop as desired.
Slovenian: Nato se dajeta zdravilo Ovaleap in agonist GnRH do želenega razvoja foliklov.
English: • ovarian, uterine or mammary carcinoma.
Slovenian: • karcinom jajčnika, maternice ali dojk
English: How to use Ovaleap
Slovenian: Kako uporabljati zdravilo Ovaleap
English: Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting, diarrhoea
Slovenian: Bolezni prebavil pogosti bolečine v trebuhu, trebušna distenzija, nelagodje v trebuhu, navzea, bruhanje, driska
English: • Breast development
Slovenian: • razvoj dojk
English: For the following treatment cycle, your doctor will give you a higher starting dose of this medicine than before.
Slovenian: Za naslednji ciklus zdravljenja vam bo vaš zdravnik predpisal zdravljenje z večjim začetnim odmerkom tega zdravila kot v predhodnem ciklusu.
English: INFORMATION IN BRAILLE Ovaleap 900 IU/1.5 mL
Slovenian: PODATKI V BRAILLOVI PISAVI Ovaleap 900 i.e./1,5 ml
English: However, since Ovaleap is not indicated in pregnancy, these data are of limited clinical relevance.
Slovenian: Vendar pa imajo ti podatki le omejen klinični pomen, ker zdravilo Ovaleap ni indicirano v nosečnosti.
English: • ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome;
Slovenian: • povečanje jajčnika ali ciste jajčnika, za katera vzrok ni sindrom policističnega jajčnika
English: You must follow the separate instructions for use of the Ovaleap Pen carefully.
Slovenian: Za uporabo injekcijskega peresnika Ovaleap Pen natančno upoštevajte ločena navodila za uporabo.