FrancophonIA/ELRC3.0 huggingface dataset:
English: • Complications of OHSS such as twisting of ovaries or blood clotting may occur rarely (may affect up to 1 in 1,000 people).
Croatian: • Komplikacije OHSS kao što su uvrtanje jajnika ili krvni ugrušci mogu rijetko nastati (mogu se javiti u manje od 1 na 1000 osoba).
English: Reproductive system neoplasms
Croatian: Novotvorine reproduktivnog sustava
English: Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and oestrogen response.
Croatian: Liječenje treba prilagoditi individualnom odgovoru pojedine pacijentice koji se procjenjuje mjerenjem veličine folikula ultrazvukom i estrogenskog odgovora.
English: • if you are a woman with: - large ovaries or sacs of fluids within the ovaries (ovarian cysts) of unknown origin.
Croatian: • ako ste žena koja ima: - povećane jajnike ili mjehuriće ispunjene tekućinom unutar jajnika (ciste jajnika) nepoznatog porijekla. - neobjašnjeno vaginalno krvarenje.
English: Write down the date of first use in the patient diary, which will be provided with the Ovaleap Pen.
Croatian: Zapišite datum prve primjene u dnevnik pacijenta, koji će biti priložen uz brizgalicu Ovaleap Pen.
English: The majority of multiple conceptions are twins.
Croatian: Većina višeplodnih trudnoća su blizanačke trudnoće.
English: EXP The cartridge in-use in the pen may be stored for a maximum of 28 days not above 25 °C.
Croatian: Uložak u uporabi u brizgalici može se čuvati najdulje 28 dana na temperaturi ne iznad 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.
Croatian: Incidencija gubitka trudnoće zbog spontanog ili izazvanog pobačaja viši je u pacijentica u kojih se stimulira rast folikula zbog indukcije ovulacije ili MPO nego nakon prirodnog začeća.
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.
Croatian: • Doza Ovaleapa može se povisiti svakih 7 ili svakih 14 dana za 37,5 do 75 IU, dok ne postignete željeni odgovor.
English: Pregnancy and breast-feeding You should not use this medicine if you are pregnant or breast-feeding.
Croatian: Ne smijete primjenjivati ovaj lijek ako ste trudni ili dojite.
English: Teva Biotech GmbH Dornierstraße 10 D-89079 Ulm Germany
Croatian: Teva Biotech GmbH Dornierstraße 10 D-89079 Ulm Njemačka
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva često akne
English: You are more likely to have a miscarriage than the average woman when undergoing assisted reproductive technology or stimulation of your ovaries to produce eggs.
Croatian: Vjerojatnost pobačaja veća je kod Vas nego kod prosječne žene kad se primjenjuju metode potpomognute oplodnje ili stimulacija jajnika zbog stvaranja jajašaca.
English: In clinical studies comparing r-hFSH (follitropin alfa) and urinary FSH in ART (see table 3 below) and in ovulation induction, follitropin alfa was more potent than urinary FSH in terms of a lower total dose and a shorter treatment period needed to trigger follicular maturation.
Croatian: U kliničkim ispitivanjima u kojima se uspoređivao r-hFSH (folitropin alfa) i urinarni FSH kod MPO (vidjeti tablicu 3 u nastavku) i kod indukcije ovulacije, folitropin alfa bio je potentniji od urinarnog FSH u smislu niže ukupne doze i kraćeg razdoblja liječenja potrebnog da se potakne sazrijevanje folikula.
English: - cancer in your ovaries, womb or breasts.
Croatian: • karcinom jajnika, maternice ili dojke.
English: You are more likely to have a pregnancy outside the womb (an ectopic pregnancy) than the average woman when undergoing assisted reproductive technology and if you have damaged fallopian tubes.
Croatian: Vjerojatnost trudnoće izvan maternice (ektopične trudnoće) veća je kod Vas nego kod prosječne žene kad se provode metode potpomognute oplodnje ili ako imate oštećene jajovode.
English: Ovaleap contains 0.02 mg per mL of benzalkonium chloride Ovaleap contains 10.0 mg per mL of benzyl alcohol For the full list of excipients, see section 6.1.
Croatian: Ovaleap sadrži 0,02 mg po ml benzalkonijeva klorida Ovaleap sadrži 10,0 mg po ml benzilnog alkohola Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
English: • if you have a tumour in your hypothalamus or pituitary gland (parts of the brain).
Croatian: • ako imate tumor hipotalamusa ili hipofize (dijelovi mozga).
English: Ovaleap contains sodium, benzalkonium chloride and benzyl alcohol This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Croatian: Ovaleap sadrži natrij, benzalkonij klorid i benzilni alkohol Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, to jest, zanemarive količine natrija.
English: In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/L.
Croatian: U kliničkim se ispitivanjima to stanje kod pacijentica definiralo razinom endogenog LH u serumu od < 1,2 IU/l.
English: Ovaleap is not indicated during breast-feeding.
Croatian: Ovaleap nije indiciran tijekom dojenja.
English: Safety and effectiveness of follitropin alfa in elderly patients have not been established.
Croatian: Sigurnost i učinkovitost folitropina alfa u starije populacije nisu ustanovljene.
English: Mild to severe hypersensitivity reactions, including anaphylactic reactions and shock
Croatian: Poremećaji imunološkog sustava vrlo rijetko blage do jake reakcije preosjetljivosti, uključujući anafilaktičke reakcije i šok
English: Do not attempt to self-administer this medicine without this training by your doctor or nurse.
Croatian: Nemojte pokušati sami sebi dati ovaj lijek a da Vam liječnik ili medicinska sestra nisu prethodno pokazali kako to učiniti.
English: The steady state volume of distribution and total clearance are 10 L and 0.6 L/h, respectively.
Croatian: Volumen raspodjele kod stanja dinamičke ravnoteže iznosi 10 l, a ukupni klirens 0,6 l/sat.
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.
Croatian: Žene koje u anamnezi imaju bolesti jajovoda izložene su većem riziku od ektopične trudnoće, bilo da je trudnoća nastupila spontanim začećem ili liječenjem neplodnosti.
English: One-eighth of the follitropin alfa dose is excreted in the urine.
Croatian: Jedna osmina doze folitropina alfa izluči se mokraćom.
English: This medicine is given as an injection into the tissue just under the skin (subcutaneous injection) using the Ovaleap Pen.
Croatian: Ovaj se lijek daje injekcijom u tkivo neposredno ispod kože (potkožna injekcija) pomoću brizgalice Ovaleap Pen.
English: Manufacturer Teva Biotech GmbH Dornierstraße 10 89079 Ulm Germany
Croatian: Proizvođač Teva Biotech GmbH Dornierstraße 10 89079 Ulm Njemačka
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).
Croatian: Najčešće zabilježene nuspojave su glavobolja, ciste jajnika i lokalne reakcije na mjestu primjene injekcije (npr. bol, eritem, hematom, otečenost i/ili nadraženost na mjestu primjene injekcije).
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.
Croatian: U žena s anovulacijom, cilj terapije folitropinom alfa je razviti jedan zreli Graafov folikul iz kojeg će se osloboditi jajna stanica nakon primjene hCG.
English: What Ovaleap is
Croatian: Što je Ovaleap
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated.
Croatian: Prije početka liječenja potrebno je napraviti prikladnu procjenu neplodnosti i utvrditi kontraindikacije za trudnoću.
English: • Local reactions at the injection site, such as pain, redness, bruising, swelling and/or irritation
Croatian: • lokalne reakcije na mjestu primjene injekcije, kao što su bol, crvenilo, modrice, otečenost i/ili nadraženost
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of the solution contains 600 IU (equivalent to 44 micrograms) follitropin alfa*.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml otopine sadrži 600 IU (što odgovara 44 mikrograma) folitropina alfa*.
English: • gynaecological haemorrhages of unknown aetiology;
Croatian: • ginekološka krvarenja nepoznatog uzroka;
English: Very rare (may affect up to 1 in 10,000 people)
Croatian: Vrlo rijetko (mogu se javiti u manje od 1 na 10 000 osoba)
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”.
Croatian: • za poticanje razvoja folikula u žena u kojih se provode postupci medicinski potpomognute oplodnje (postupci koji Vam mogu pomoći da zatrudnite), kao što su „in vitro oplodnja“, „unošenje gamete u jajovod“ ili „unošenje zigote u jajovod“.
English: follitropin alfa (n = 130)
Croatian: (n = 130)
English: However, the OHSS will only occur if hCG is also administered [see also section 2 under “Ovarian Hyper-Stimulation Syndrome (OHSS)”].
Croatian: Međutim, OHSS će nastati samo ako se primijeni i hCG [pogledajte također dio 2 pod „Sindrom hiperstimulacije jajnika (OHSS)“].
English: • tumours of the hypothalamus or pituitary gland;
Croatian: • tumori hipotalamusa ili hipofize;
English: What Ovaleap is used for
Croatian: Za što se Ovaleap koristi
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)”].
Croatian: To može ukazivati na prejaku reakciju jajnika na liječenje i razvoj velikih cista [pogledajte također dio 2 pod „Sindrom hiperstimulacije jajnika (OHSS)“].
English: Down-regulation with a gonadotropin-releasing hormone (GnRH) agonist or antagonist is now commonly used in order to suppress the endogenous LH surge and to control tonic levels of LH.
Croatian: Danas se uobičajeno primjenjuje agonist hormona koji oslobađa gonadotropin (GnRH) kako bi se potisnuo porast endogenog LH i kontrolirale toničke razine LH.
English: No direct comparison of follitropin alfa/LH versus human menopausal gonadotropin (hMG) has been performed.
Croatian: Folitropin alfa/LH nije izravno uspoređen s humanim menopauzalnim gonadotropinom (hMG).
English: Benzalkonium chloride content Ovaleap contains 0.02 mg/mL of benzalkonium chloride
Croatian: Sadržaj benzalkonijeva klorida Ovaleap sadrži 0,02 mg/ml benzalkonijeva klorida
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.
Croatian: Žene s anovulacijom zbog teškog nedostatka LH i FSH U žena s nedostatkom LH i FSH (hipogonadotropni hipogonadizam), cilj terapije folitropinom alfa u kombinaciji s lutropinom alfa je razvoj jednog zrelog Graafovog folikula iz kojeg će se osloboditi oocita nakon primjene hCG.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications In adult women
Croatian: 4.1 Terapijske indikacije
English: The patients should be advised of the potential risk of multiple births before starting treatment.
Croatian: Prije početka liječenja, pacijentice treba upozoriti na mogući rizik od višeplodne trudnoće.
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.
Croatian: • Ako primjenjujete Ovaleap u isto vrijeme kao i agonist ili antagonist „hormona koji oslobađa gonadotropin“ (GnRH) (ti lijekovi snižavaju razine spolnih hormona i zaustavljaju ovulaciju)
English: If an FSH dose increase is deemed appropriate, dose adaptation should preferably be at 7-14 day intervals and preferably with 37.5-75 IU increments.
Croatian: Ako se smatra da bi bilo primjereno povisiti dozu FSH, dozu treba po mogućnosti prilagođavati u vremenskim razmacima od 7-14 dana, a povećanje bi po mogućnosti trebalo iznositi 37,5-75 IU.
English: - any condition that usually makes normal pregnancy impossible, such as ovarian failure (early menopause), fibroid tumours of the womb or malformed reproductive organs.
Croatian: - rak jajnika, maternice ili dojke. - bilo koje stanje koje obično onemogućuje normalnu trudnoću, kao što su zatajenje jajnika (rana menopauza), fibroidni tumori maternice ili deformacija spolnih organa.
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.
Croatian: • Stimulacija razvoja većeg broja folikula u žena u kojih se stimulira superovulacija zbog medicinski potpomognute oplodnje (MPO) kao što su oplodnja in vitro (IVF), unošenje gamete u jajovod i unošenje zigote u jajovod.
English: Patients undergoing stimulation of follicular growth, whether as treatment for anovulatory infertility or ART procedures, may experience ovarian enlargement or develop hyperstimulation.
Croatian: U pacijentica u kojih se provodi stimulacija rasta folikula, bilo kao liječenje anovulacijske neplodnosti ili u sklopu postupaka MPO-a, može doći do povećanja jajnika ili nastanka hiperstimulacije.
English: Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and/or oestrogen secretion.
Croatian: Liječenje treba biti prilagođeno odgovoru pojedine pacijentice koji se procjenjuje mjerenjem veličine folikula ultrazvukom i/ili lučenjem estrogena.
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 (%)
Croatian: Dani potrebne stimulacije FSH-om 11,7 ± 1,9 Ukupna potrebna doza FSH (broj ampula FSH od 75 IU)
English: INFORMATION IN BRAILLE Ovaleap 450 IU/0.75 mL
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Ovaleap 450 IU/0,75 ml
English: Other side effects in women
Croatian: Druge nuspojave u žena
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.
Croatian: - Drugi sastojci su natrijev dihidrogenfosfat dihidrat, natrijev hidroksid (2 M) (za podešavanje pH), manitol, metionin, polisorbat 20, benzilni alkohol, benzalkonijev klorid i voda za injekcije.
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)
Croatian: • lokalne reakcije na mjestu injekcije, kao što je bol, crvenilo, modrica, otečenost i/ili nadraženost Često (mogu se javiti u manje od 1 na 10 osoba)
English: Ovaleap cartridges are not designed to allow any other medicinal product to be mixed in the cartridges.
Croatian: Ulošci Ovaleap napravljeni su tako da se u njih ne može dodati neki drugi lijek.
English: • ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome;
Croatian: • povećanje jajnika ili cista jajnika koja nije uzrokovana sindromom policističnih jajnika;
English: If your body responds too strongly, your treatment with Ovaleap will be stopped and you will not be given any hCG [see also section 2 under “Ovarian Hyper-Stimulation Syndrome (OHSS)”].
Croatian: Ako odgovor Vašeg tijela bude prejak, liječenje Ovaleapom bit će prekinuto i nećete dobiti hCG [pogledajte također dio 2 pod „Sindrom hiperstimulacije jajnika (OHSS)“].
English: If your body responds too strongly, your treatment will be stopped and you will not be given any hCG [see also section 2 under “Ovarian Hyper-Stimulation Syndrome (OHSS)”].
Croatian: Ako odgovor Vašeg tijela bude prejak, liječenje će biti zaustavljeno i nećete dobiti hCG [pogledajte također dio 2 pod „Sindrom hiperstimulacije jajnika (OHSS)“].
English: Injection needles (stainless steel; 0.33 mm x 12 mm, 29 G x ½") Pack size of 1 cartridge and 20 injection needles.
Croatian: Igle za injekciju (nehrđajući čelik: 0,33 mm x 12 mm, 29 G x ½").
English: Must be discarded if it has not been used after 3 months.
Croatian: Ako se nije primijenio, mora se baciti nakon 3 mjeseca.
English: Severe OHSS is uncommon (see section 4.4).
Croatian: Teški OHSS manje je čest (vidjeti dio 4.4).
English: There is no relevant use of follitropin alfa in the paediatric population.
Croatian: Pedijatrijska populacija Nema relevantne primjene folitropina alfa u pedijatrijskoj populaciji.
English: Excipients: sodium dihydrogen phosphate dihydrate, sodium hydroxide (2 M) (for pH adjustment), mannitol, methionine, polysorbate 20, benzyl alcohol, benzalkonium chloride, water for injections.
Croatian: Pomoćne tvari: natrijev dihidrogenfosfat dihidrat, natrijev hidroksid (2 M) (za podešavanje pH), manitol, metionin, polisorbat 20, benzilni alkohol, benzalkonijev klorid, voda za injekcije.
English: Each mL of the solution contains 600 IU (equivalent to 44 micrograms) follitropin alfa.
Croatian: Jedan ml otopine sadrži 600 IU (što odgovara 44 mikrograma) folitropina alfa.
English: How to store Ovaleap
Croatian: Kako čuvati Ovaleap
English: For the following treatment cycle, your doctor will give you a higher starting dose of this medicine than before.
Croatian: U sljedećim ciklusima liječenja, liječnik će Vam dati višu početnu dozu ovog lijeka nego prije.
English: In ART, follitropin alfa at a lower total dose and shorter treatment period than urinary FSH, resulted in a higher number of oocytes retrieved when compared to urinary FSH.
Croatian: Kod MPO, folitropin alfa je u nižoj ukupnoj dozi i kraćem razdoblju liječenja nego urinarni FSH doveo do većeg broja dobivenih oocita u usporedbi s urinarnim FSH.
English: Sodium content Ovaleap contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodiumfree”.
Croatian: Ovaleap sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: Monitoring of stimulation cycles by ultrasound scans as well as oestradiol measurements are recommended to early identify risk factors.
Croatian: Za rano otkrivanje čimbenika rizika preporučuje se praćenje ciklusa stimulacije ultrazvučnim pregledima, kao i mjerenjem estradiola.
English: The instructions for use of the pen will be provided together with the Ovaleap Pen.
Croatian: Upute za uporabu brizgalice priložene su uz Ovaleap Pen.
English: Ovaleap solution for injection in cartridges has been developed for use in the Ovaleap Pen.
Croatian: Ovaleap otopina za injekciju u ulošcima prilagođena je za primjenu s brizgalicom Ovaleap Pen.
English: The patient should write down in the patient diary provided with the Ovaleap Pen the date of first use.
Croatian: Pacijent treba zapisati datum prve primjene u dnevnik za pacijenta priložen uz brizgalicu Ovaleap Pen.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS CARTRIDGE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE ULOŽAK
English: INFORMATION IN BRAILLE Ovaleap 900 IU/1.5 mL
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Ovaleap 900 IU/1,5 ml
English: For the following cycle, your doctor will give you a higher starting dose of this medicine than before.
Croatian: U sljedećem ciklusu liječnik će Vam dati višu početnu dozu ovog lijeka nego prije.
English: • Sacs of fluid within the ovaries (ovarian cysts) Common (may affect up to 1 in 10 people)
Croatian: • mjehurići tekućine unutar jajnika (ciste jajnika) Često (mogu se javiti u manje od 1 na 10 osoba)
English: INFORMATION IN BRAILLE Ovaleap 300 IU/0.5 mL
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Ovaleap 300 IU/0,5 ml
English: Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting, diarrhoea
Croatian: Poremećaji probavnog sustava često bol u abdomenu, distenzija abdomena, nelagoda u abdomenu, mučnina, povraćanje, proljev
English: Ovaleap is designed for use in conjunction with the Ovaleap Pen only.
Croatian: Ovaleap je napravljen za primjenu samo s brizgalicom Ovaleap Pen.
English: You must discard this medicine if it has not been used after 3 months.
Croatian: Ako ga niste primijenili, lijek morate baciti nakon 3 mjeseca.
English: Ovaleap 900 IU/1.5 mL: Each cartridge contains 900 IU (equivalent to 66 micrograms) follitropin alfa in 1.5 mL solution.
Croatian: Ovaleap 900 IU/1,5 ml: jedan uložak sadrži 900 IU (što odgovara 66 mikrograma) folitropina alfa u 1,5 ml otopine.
English: The Ovaleap cartridge is designed for use in conjunction with the Ovaleap Pen only, which is separately available.
Croatian: Uložak Ovaleapa napravljen je tako da se primjenjuje samo s brizgalicom Ovaleap Pen, koja je dostupna u zasebnom pakiranju.
English: For the following cycle, your doctor will give you a lower dose of Ovaleap than before.
Croatian: U sljedećem ciklusu, liječnik će Vam dati nižu dozu Ovaleapa nego prije.
English: This side effect is uncommon (may affect up to 1 in 100 people).
Croatian: Ova nuspojava je manje česta (mogu se javiti u manje od 1 na 100 osoba).
English: Ovaleap 900 IU/1.5 mL solution for injection EU/1/13/871/003
Croatian: Ovaleap 900 IU/1,5 ml otopina za injekciju EU/1/13/871/003
English: METHOD AND ROUTE(S) OF ADMINISTRATION For use only with the Ovaleap Pen.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Samo za primjenu s brizgalicom Ovaleap Pen.
English: Ovaleap 450 IU/0.75 mL solution for injection EU/1/13/871/002
Croatian: Ovaleap 450 IU/0,75 ml otopina za injekciju EU/1/13/871/002
English: Ovaleap 450 IU/0.75 mL is available in packs containing 1 cartridge and 10 injection needles.
Croatian: Ovaleap 450 IU/0,75 ml je dostupan u pakiranjima koja sadrže 1 uložak i 10 igala za injekciju.
English: Ovaleap 900 IU/1.5 mL is available in packs containing 1 cartridge and 20 injection needles.
Croatian: Ovaleap 900 IU/1,5 ml je dostupan u pakiranjima koja sadrže 1 uložak i 20 igala za injekciju.
English: Ovaleap 450 IU/0.75 mL: Each cartridge contains 450 IU (equivalent to 33 micrograms) follitropin alfa in 0.75 mL solution.
Croatian: Ovaleap 450 IU/0,75 ml: jedan uložak sadrži 450 IU (što odgovara 33 mikrograma) folitropina alfa u 0,75 ml otopine.
English: Before the treatment is started you and your partner's fertility should be evaluated by a doctor experienced in treating fertility disorders.
Croatian: Prije početka liječenja liječnik s iskustvom u liječenju poremećaja plodnosti treba procijeniti Vašu plodnost i plodnost Vašeg partnera ili partnerice.
English: Ovaleap 300 IU/0.5 mL is available in packs containing 1 cartridge and 10 injection needles.
Croatian: Ovaleap 300 IU/0,5 ml je dostupan u pakiranjima koja sadrže 1 uložak i 10 igala za injekciju.
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.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je zamućen ili sadrži čestice.
English: Ask your doctor or pharmacist for advice if you have a liver or kidney disease, and if you are pregnant or breast-feeding.
Croatian: Obratite se svom liječniku ili ljekarniku za savjet ako imate bolest jetre ili bubrega te ako ste trudni ili dojite, jer se velike količine benzilnog alkohola mogu nakupiti u Vašem tijelu i uzrokovati nuspojave (zvane „metabolička acidoza“).