natgillin/translations-raw huggingface dataset:
• if you are allergic to follitropin alfa, Follicle Stimulating Hormone (FSH) or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na folitropin alfa, folikle stimulirajoči hormon (FSH) ali katero koli sestavino tega zdravila, navedeno v poglavju 6.
In patients undergoing ovulation induction, the incidence of multiple pregnancy is increased compared with natural conception.
Pri bolnicah v postopku indukcije ovulacije je pogostnost večplodne nosečnosti, v primerjavi z naravno zanositvijo, povečana.
Impaired fertility has been reported in rats exposed to pharmacological doses of follitropin alfa (≥ 40 IU/kg/day) for extended periods, through reduced fecundity.
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.
No direct comparison of follitropin alfa/LH versus human menopausal gonadotropin (hMG) has been performed.
Direktna primerjava med folitropinom alfa/LH in humanim menopavzalnim gonadotropinom (hMG) ni bila izvedena.
Safety and effectiveness of follitropin alfa in elderly patients have not been established.
Varnost in učinkovitost folitropina alfa pri starejših bolnikih nista bili dokazani.
If you are developing OHSS your doctor may not give you any hCG in this treatment cycle.
Če se pri vas razvije sindrom hiperstimulacije jajčnikov, vam zdravnik ne sme dati hCG v tem ciklusu zdravljenja.
*Follitropin alfa (recombinant human follicle-stimulating hormone [r-hFSH]) is produced in Chinese Hamster Ovary Cells (CHO DHFR-) by recombinant DNA technology.
*Folitropin alfa (rekombinantni humani folikle stimulirajoči hormon [r-hFSH]), pridobljen iz celic jajčnika kitajskega hrčka (CHO DHFR) z uporabo tehnologije rekombinante DNA.
• The usual starting dose of this medicine is 75 to 150 IU each day.
• Običajni začetni odmerek tega zdravila je 75 do 150 i.e. vsak dan.
• Serious blood clotting complications (thromboembolic events), sometimes independent of OHSS, may be found very rarely (may affect up to 1 in 10,000 people).
• Resni zapleti zaradi krvnih strdkov (trombembolični dogodki), ki so včasih neodvisni od OHSS, so zelo redki (prizadenejo lahko največ 1 od 10.000 bolnic).
• Lower stomach ache together with nausea or vomiting may be the symptoms of Ovarian Hyper-Stimulation Syndrome (OHSS).
• Bolečine v spodnjem delu trebuha skupaj s slabostjo ali bruhanjem so lahko simptomi sindroma hiperstimulacije jajčnikov (OHSS).
Severe OHSS (including associated symptomatology) (see section 4.4)
občasni hud OHSS (vključno s povezanimi simptomi) (glejte poglavje 4.4)
● At the request of the European Medicines Agency;
Posodobljen RMP je treba predložiti: ● na zahtevo Evropske agencije za zdravila;
This medicine usually does not work if you have this problem.
V takih primerih to zdravilo običajno ni učinkovito.
• Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene citrate.
• Anovulacija (vključno s sindromom policističnih jajčnikov) pri ženskah, ki se niso odzvale na zdravljenje s klomifen citratom.
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.
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.
If your doctor cannot see a response after 5 weeks, that treatment cycle should be stopped.
Če vaš zdravnik ne more doseči odziva po 5 tednih zdravljenja, je treba ciklus zdravljenja opustiti.
Women undergoing ovarian stimulation for multiple follicular development prior to in vitro fertilisation or other ART
Ženske v postopku stimulacije ovarijev za doseganje razvoja več foliklov pred in vitro oploditvijo ali drugimi ART
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.
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.
This medicine is given as an injection into the tissue just under the skin (subcutaneous injection).
To zdravilo se daje kot injekcija v tkivo tik pod kožo (subkutana injekcija).
What Ovaleap looks like and contents of the pack Ovaleap is a solution for injection (injection).
Izgled zdravila Ovaleap in vsebina pakiranja Zdravilo Ovaleap je raztopina za injiciranje (injekcije).
What you need to know before you use Ovaleap
Kaj morate vedeti, preden boste uporabili zdravilo Ovaleap
Discard used needles immediately after injection.
Uporabljene injekcijske igle zavrzite takoj po injiciranju.
• 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.
• 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.
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.
Razpon odziva na zdravljenje s FSH se lahko med bolniki razlikuje, pri nekaterih bolnikih je odziv na FSH zelo majhen in pri drugih pretiran.
• The usual starting dose of Ovaleap is 75 to 150 IU together with 75 IU of lutropin alfa.
• Običajni začetni odmerek zdravila Ovaleap je 75 do 150 i.e. skupaj s 75 i.e. lutropina alfa.
Patients undergoing stimulation of follicular growth, whether as treatment for anovulatory infertility or ART procedures, may experience ovarian enlargement or develop hyperstimulation.
Pri bolnicah v postopku stimulacije folikularne rasti, bodisi kot zdravljenje anovulacijske neplodnosti ali v postopkih ART, se lahko povečajo jajčniki ali se razvije hiperstimulacija.
• primary testicular insufficiency.
• primarna insuficienca testisov
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.
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.
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).
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).
• 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).
• 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).
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.
Pri ženskah z boleznijo jajcevodov v anamnezi obstaja tveganje zunajmaternične nosečnosti, ne glede na to ali pride do zanositve spontano ali z zdravljenjem neplodnosti.
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.
Pri ženskah z zavrtim izločanjem endogenega gonadotropina pa se je izkazalo, da folitropin alfa učinkovito spodbuja razvoj foliklov in steroidogenezo, kljub nemerljivim ravnem LH.
• 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.
• 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.
Ovaleap cartridges are not designed to allow any other medicinal product to be mixed in the cartridges.
Vložki zdravila Ovaleap so oblikovani tako, da ne dopuščajo mešanja z drugim zdravilom v vložkih.
The solution must not be used if it contains particles or if the solution is not clear.
Raztopine ne uporabljajte, če vsebuje delce ali ni bistra.
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.
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.
Ovaleap is intended for subcutaneous use.
Zdravilo Ovaleap je namenjeno za subkutano uporabo.
• 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.
• v kombinaciji z zdravilom "humani horionski gonadotropin" (hCG) za pomoč pri tvorbi sperme pri moških, ki so neplodni zaradi nizke ravni nekaterih hormonov.
Ovarian Hyperstimulation Syndrome (OHSS)
Sindrom hiperstimulacije jajčnikov (OHSS, Ovarian Hyperstimulation Syndrome)
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.
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.
In adult women, Ovaleap is used:
Pri odraslih ženskah se zdravilo Ovaleap uporablja:
The prevalence of ectopic pregnancy after ART, was reported to be higher than in the general population.
Poročali so o višji prevalenci zunajmaternične nosečnosti po ART kot pri splošni populaciji.
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.
Pred odprtjem in v času roka uporabnosti se lahko zdravilo vzame iz hladilnika in se shranjuje zunaj njega do 3 mesece.
• primary ovarian failure;
• primarna odpoved jajčnikov
• 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”.
• 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";
Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and oestrogen response.
Zdravljenje mora biti prilagojeno odzivu posamezne bolnice, ki se oceni z merjenjem velikosti folikla z ultrazvokom in estrogenskim odzivom.
Following repeated administration, follitropin alfa accumulates 3-fold achieving a steady-state within 3-4 days.
Po večkratnem dajanju, doseže folitropin alfa trikratno raven v plazmi in doseže stanje dinamičnega ravnovesja v 3 do 4 dneh.
Teva Biotech GmbH Dornierstraße 10 D-89079 Ulm Germany
Teva Biotech GmbH Dornierstraße 10 D-89079 Ulm Nemčija
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.
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).
• Local reactions at the injection site, such as pain, redness, bruising, swelling and/or irritation
• lokalne reakcije na mestu injiciranja kot so bolečina, pordelost, modrice, oteklina in/ali draženje
In clinical trials, an increase of the ovarian sensitivity to follitropin alfa was shown when administered with lutropin alfa.
V kliničnih študijah se je pokazalo, da se poveča občutljivost jajčnikov za folitropin alfa, kadar se uporablja skupaj z lutropinom alfa.
• Complications of OHSS such as twisting of ovaries or blood clotting may occur rarely (may affect up to 1 in 1,000 people).
• Zapleti OHSS, kot je torzija jajčnikov ali nastajanje krvnih strdkov, se pojavijo redko (prizadenejo lahko največ 1 od 1.000 bolnic).
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 (%)
Skupni odmerek potrebnega FSH (število ampul FSH 75 i.e.) Potreba po zvišanju odmerka (%)
EXP The cartridge in-use in the pen may be stored for a maximum of 28 days not above 25 °C.
EXP Vložek v injekcijskem peresniku lahko shranjujete največ 28 dni pri temperaturi do 25 °C.
Other medicines and Ovaleap Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
Ovaleap is a biosimilar medicinal product.
Zdravilo Ovaleap je podobno biološko zdravilo.
Mild to severe hypersensitivity reactions, including anaphylactic reactions and shock
Bolezni imunskega sistema zelo redki blage do hude preobčutljivostne reakcije, vključno z anafilaktičnimi reakcijami in šokom
Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events such as pulmonary embolism, ischaemic stroke or myocardial infarction.
Pri hudem OHSS je lahko zelo redek zaplet tudi torzija jajčnikov ali trombembolični dogodki kot so pljučni embolizem, ishemični cerebrovaskularni insult ali miokardni infarkt.
Do not use this medicine after the expiry date which is stated on the label and outer carton after EXP.
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.
The Ovaleap Pen is a device (a “pen”) used for giving injections into the tissue just under the skin.
Injekcijski peresnik Ovaleap Pen je pripomoček ("peresnik") za dajanje injekcij v tkivo tik pod kožo.
The pen cap must be put back on the pen after each injection in order to protect from light.
Pokrov peresnika je treba po vsakem injiciranju dati nazaj na peresnik za zagotovitev zaščite pred svetlobo.
The dose recommendations given for follitropin alfa are those in use for urinary FSH.
Priporočeni odmerek za folitropin alfa je enak kot za urinarni FSH.
• 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.
• 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.
Manufacturer Teva Biotech GmbH Dornierstraße 10 89079 Ulm Germany
Izdelovalec Teva Biotech GmbH Dornierstraße 10 89079 Ulm Nemčija
CLINICAL PARTICULARS 4.1 Therapeutic indications In adult women
4.1 Terapevtske indikacije
What Ovaleap contains - The active substance is follitropin alfa.
Kaj vsebuje zdravilo Ovaleap - Učinkovina je folitropin alfa.
Ovaleap treatment seldom causes severe OHSS unless the medicine that is used for final follicular maturation (containing human chorionic gonadotropin, hCG) is given.
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).
If your doctor cannot see a desired response after 4 weeks, that treatment cycle with Ovaleap should be stopped.
Če vaš zdravnik ne more doseči ustreznega odziva po 4 tednih zdravljenja, je treba ciklus zdravljenja z zdravilom Ovaleap opustiti.
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.
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.
• 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.
• Zdravilo Ovaleap se priporoča skupaj z luteinizirajočim hormonom (LH) za spodbujanje razvoja foliklov pri ženskah s hudim pomanjkanjem LH in FSH.
• if you have a tumour in your hypothalamus or pituitary gland (parts of the brain).
• če imate tumor hipotalamusa ali hipofize (dela možganov).
• Local reactions at the injection site, such as pain, redness, bruising, swelling and/or irritation Common (may affect up to 1 in 10 people)
• lokalne reakcije na mestu injiciranja kot so bolečina, pordelost, modrice, oteklina in/ali draženje Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov)
- 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.
- 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.
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.
Ne uporabljajte tega zdravila, če opazite, da je raztopina motna ali da so v njej delci.
In adult men, Ovaleap is used:
Pri odraslih moških se zdravilo Ovaleap uporablja:
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).
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).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
V razvrstitvah pogostnosti so neželeni učinki razvrščeni po padajoči resnosti Zdravljenje žensk
However, the OHSS will only occur if hCG is also administered [see also section 2 under “Ovarian Hyper-Stimulation Syndrome (OHSS)”].
OHSS pa se lahko pojavi samo, če se uporabi tudi hCG [glejte tudi poglavje 2 "Sindrom hiperstimulacije jajčnikov (OHSS)"].
• When you get the desired response, you will be given hCG or r-hCG.
• Ko boste dosegli želeni odziv, boste prejeli hCG ali r-hCG. Ena injekcija bo vsebovala
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.
Pri ženskah z anovulacijo je cilj zdravljenja s folitropinom alfa razvoj enega zrelega Graafovega folikla, iz katerega se bo po dajanju hCG sprostilo jajčece.
This medicine is given as an injection into the tissue just under the skin (subcutaneous injection) using the Ovaleap Pen.
To zdravilo se daje kot injekcija v tkivo tik pod kožo (subkutana injekcija) z uporabo injekcijskega peresnika Ovaleap Pen.
Excipients: sodium dihydrogen phosphate dihydrate, sodium hydroxide (2 M) (for pH adjustment), mannitol, methionine, polysorbate 20, benzyl alcohol, benzalkonium chloride, water for injections.
Pomožne snovi: natrijev dihidrogenfosfat dihidrat, natrijev hidroksid (2 M) (za uravnavanje pH), manitol, metionin, polisorbat 20, benzilalkohol, benzalkonijev klorid, voda za injekcije.
Ovaleap solution for injection in cartridges has been developed for use in the Ovaleap Pen.
Zdravilo Ovaleap raztopina za injiciranje v vložkih je bilo razvito za uporabo v injekcijskih peresnikih Ovaleap Pen.
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.
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.
Monitoring of stimulation cycles by ultrasound scans as well as oestradiol measurements are recommended to early identify risk factors.
Za zgodnje odkrivanje dejavnikov tveganja se priporoča nadzor stimulacije ciklusov z ultrazvokom in merjenjem estradiola.
Sodium content Ovaleap contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodiumfree”.
Zdravilo Ovaleap vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni 'brez natrija'.
May be stored before opening not above 25 °C for up to 3 months.
Pred uporabo se lahko zdravilo shranjuje 3 mesece pri temperaturi do 25 °C.
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.
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.
The Ovaleap cartridge is designed for use in conjunction with the Ovaleap Pen only, which is separately available.
Vložek zdravila Ovaleap je zasnovan samo za uporabo v povezavi z injekcijskim peresnikom Ovaleap Pen, ki je na voljo ločeno.
Ovaleap is not indicated during breast-feeding.
Zdravilo Ovaleap ni indicirano v obdobju dojenja.
There is no relevant use of follitropin alfa in the paediatric population.
Pediatrična populacija Folitropin alfa ni namenjen za uporabo pri pediatrični populaciji.
• 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.
• Sočasna uporaba zdravila Ovaleap z drugimi zdravili za stimuliranje ovulacije, kot sta humani horionski gonadotropin (hCG) ali klomifen citrat, lahko poveča folikularni odziv.