FrancophonIA/ELRC3.0 huggingface dataset:
English: You or your child may be monitored by your doctor or nurse for an additional hour after the infusion.
Croatian: Nakon infuzije liječnik ili medicinska sestra može nadzirati Vas ili Vaše dijete tijekom još sat vremena.
English: What KANUMA contains
Croatian: KANUMA sadrži natrij
English: Two patients were determined to be positive for antibodies that inhibit in vitro enzyme activity and cellular uptake of the enzyme.
Croatian: U dva bolesnika utvrđena je prisutnost protutijela koja inhibiraju in vitro enzimsku aktivnost i unos enzima u stanicu.
English: ADA titres decreased to undetectable levels during continued treatment in 3 of the 4 patients.
Croatian: Titar ADA-a se u 3 od 4 bolesnika smanjio na nemjerljive razine tijekom nastavka liječenja.
English: Trisodium citrate dihydrate Citric acid monohydrate Human serum albumin Water for injections
Croatian: 6.1 Popis pomoćnih tvari trinatrijev citrat dihidrat citratna kiselina hidrat albumin, ljudski, serumski voda za injekcije
English: Deficient LAL enzyme activity results in the lysosomal accumulation of cholesteryl esters and triglycerides.
Croatian: Nedostatak enzimske aktivnosti LAL-a ima za posljedicu nakupljanje kolesterolskih estera i triglicerida u lizosomima.
English: There is limited information on the impact of anti-drug antibodies on sebelipase alfa pharmacokinetics.
Croatian: Informacije o utjecaju protutijela na lijek na farmakokinetiku sebelipaze alfa su ograničene.
English: Laryngeal oedema e, dyspnoea b,c,e
Croatian: Edem larinksae, dispnejab,c,e,
English: For diluted solutions, immediate use is recommended.
Croatian: Preporučuje se razrijeđenu otopinu primijeniti odmah.
English: Therefore, appropriate medical support must be readily available when sebelipase alfa is administered.
Croatian: Zbog toga je pri davanju sebelipaze alfa potrebno imati odgovarajuću medicinsku potporu koja je lako dostupna.
English: , abdominal pain b,e abdominal distension, nausea b e
Croatian: , distenzija abdomena, mučnina b e
English: Adverse reactions are listed by System Organ Class and frequency.
Croatian: Nuspojave su prikazane prema klasifikaciji organskih sustava i učestalosti.
English: Mechanism of action Sebelipase alfa is a recombinant human lysosomal acid lipase (rhLAL).
Croatian: Sebelipaza alfa je rekombinantna ljudska lizosomska kisela lipaza (engl. recombinant human lysosomal acid lipase, rhLAL)
English: Almac Pharma Services Ltd. Seagoe Industrial Estate Craigavon
Croatian: Seagoe Industrial Estate Craigavon
English: Four (4) of 65 patients in the open label period were dose escalated to 3 mg/kg once every other week based on clinical response.
Croatian: Na temelju kliničkog odgovora u četiri (4) od 65 bolesnika u razdoblju otvorenog ispitivanja doza je povećana na 3 mg/kg jednom svaki drugi tjedan.
English: KANUMA contains the active substance sebelipase alfa.
Croatian: KANUMA sadrži djelatnu tvar sebelipazu alfa.
English: LDL-cholesterol, mean % change from baseline non-HDL-cholesterol, mean % change from baseline Normalisation of AST
Croatian: Ne-HDL kolesterol, srednja vrijednost promjene od početne vrijednosti u %
English: Renal elimination of sebelipase alfa is considered a minor pathway for clearance.
Croatian: Smatra se da se putem bubrega sebelipaza alfa eliminira u manjoj mjeri.
English: KANUMA 2 mg/ml concentrate for solution for infusion sebelipase alfa
Croatian: KANUMA 2 mg/ml koncentrat za otopinu za infuziju sebelipaza alfa (sebelipase alfa)
English: Body temperature increased, oxygen saturation decreased, blood pressure increased, heart rate increased, respiratory rate increased a
Croatian: Povišena tjelesna temperatura, smanjena zasićenost kisikom, povišen krvni tlak, ubrzana srčana frekvencija, ubrzana frekvencija disanja a Vrlo često = zabilježeno u ≥ 1 bolesnika koji je primao KANUMU
English: e. Up to 10 ml of solution should be slowly withdrawn from each vial and diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion.
Croatian: Iz svake bočice treba polako izvući do 10 ml otopine i razrijediti s otopinom natrijevog klorida za infuziju od 9 mg/ml (0,9%).
English: Trisodium citrate dihydrate (see leaflet for further information) Citric acid monohydrate
Croatian: Pomoćne tvari: trinatrij citrat dihidrat (za daljnje informacije vidjeti Uputu o lijeku) limunska kiselina monohidrat ljudski serumski albumin voda za injekcije
English: Clear to slightly opalescent, colourless to slightly coloured solution.
Croatian: Bistra do blago opalescentna, bezbojna do blago obojena otopina.
English: If the infusion reaction is severe, your doctor may stop KANUMA infusion and start giving you or your child appropriate medical treatment.
Croatian: Ako je infuzijska reakcija teška, Vaš će liječnik možda zaustaviti infuziju i započeti odgovarajuće liječenje.
English: ≥ 18 years old N=18 Week 0 Week 22* Week 0 Week 22* Week 0 Week 22* AUCss (ng∙hr/mL) 1133.8 941.6 1436.4 1453.6 1989.3 1861.0 Cmax (ng/mL) Tmax (hr) CL (L/hr) Vc (L) T1/2 (hr) * Week 22 for placebo patients reset to Week 0, i.e. first week of active treatment.
Croatian: AUCss (ng/h/ml) Cmax (ng/ml) Tmax (h) CL (l/h) Vc (l) T1/2 (h) 22. tjedan je za bolesnike koji su primali placebo zapravo 0. tjedan, tj. prvi tjedan aktivnog liječenja.
English: Frequency a
Croatian: Učestalost a
English: There is a lack of data in patients with renal impairment.
Croatian: Nedostaju podaci o blesnicima s oštećenjem bubrega.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION KANUMA 2 mg/ml sterile concentrate sebelipase alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA KANUMA 2 mg/ml sterilni koncentrat sebelipaza alfa i.v. primjena nakon razrjeđivanja
English: KANUMA 2 mg/ml concentrate for solution for infusion
Croatian: KANUMA 2 mg/ml koncentrat za otopinu za infuziju
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 20 mg sebelipase alfa in 10 ml of solution (2 mg/ml)
Croatian: TVARI Jedna bočica sadrži 20 mg sebelipaze alfa u 10 ml otopine (2 mg/ml)
English: Menorrhagia
Croatian: Pvrijednostd
English: There are no data from studies in breast-feeding women.
Croatian: Nema podataka iz ispitivanja u dojilja.
English: Urinary tract infection
Croatian: Infekcija mokraćnih puteva
English: It is a solution that is clear to slightly opalescent, and colourless to slightly coloured.
Croatian: To je bistra do blago zamućena, bezbojna do blago obojena otopina.
English: Infants presenting with LAL deficiency
Croatian: Dojenčad s kliničkom slikom nedostatka LAL-a
English: Very common side effects reported in infants (1 to 6 months old) are: eyelid swelling agitation high blood pressure decreased muscle tone difficulty breathing wheezing paleness stuffy or swollen nose sneezing cough heartburn (reflux diseases)
Croatian: oticanje vjeđa uznemirenost visok krvni tlak snižen mišićni tonus otežano disanje zviždanje pri disanju bljedilo začepljen ili otečen nos kihanje kašalj žgaravica (refluksna bolest)
English: Age at first dose: 4 to 58 years e
Croatian: Dob pri primjeni prve doze: 4 do 58 godina e Zabilježeno u ≥ 2 bolesnika koji su primali KANUMU
English: A statistically significant improvement in multiple endpoints was observed in the sebelipase alfatreated group as compared to the placebo group at the completion of the 20-week double-blind period of the study, as shown in Table 3.
Croatian: U skupini bolesnika liječenih sebelipazom alfa na kraju 20 tjedana dvostruko slijepog razdoblja ispitivanja uočeno je statistički značajno poboljšanje više ishodau usporedbi sa skupinom koja je primala placebo, kako je prikazano u Tablici
English: Very common = Reported in ≥ 1 patient receiving KANUMA
Croatian: Reakcija povezana s infuzijomc a Često = zabilježeno u ≥ 1 bolesnika koji je primao KANUMU
English: Dose escalation to 3 mg/kg once weekly should be considered based on clinical response.
Croatian: Na temelju kliničkog odgovora treba se razmotriti povećanje doze na 3 mg/kg jednom tjedno.
English: Very common Chills, hyperthermia, pyrexia b,
Croatian: Zimica, hipertermija, pireksijab, edem
English: P-value d
Croatian: Tahikardija b
English: Fertility
Croatian: Hipotonija
English: A 1-hour infusion may be considered after patient tolerability is established.
Croatian: Nakon što se ustanovi da bolesnik dobro podnosi liječenje, može se razmotriti davanje infuzije tijekom 1 sata.
English: Tachycardia
Croatian: Menoragija
English: See Table 5 for recommended total infusion volumes by weight range.
Croatian: Za preporučene ukupne volumene infuzija prema rasponu težine vidjeti Tablicu 5. Otopinu treba nježno promiješati i ne tresti.
English: oedema
Croatian: Omaglica
English: You can help by reporting any side effects you or your child may get.
Croatian: Prijavom svih sumnji na nuspojavu, koja se javila u Vas ili Vašeg djeteta, i Vi možete pomoći.
English: If you or your child gets any side effects, talk to your doctor.
Croatian: Ako primijetite bilo koju nuspojavu koja se javila u Vas ili Vašeg djeteta, potrebno je obavijestiti liječnika.
English: Urticaria, rashc,e (including rash papular and rash pruritic), prurituse, eczema e
Croatian: (uključujući papularni osip i osip koji svrbi), pruritus e, ekcem e
English: See Table 1 for recommended total infusion volumes by weight range.
Croatian: Za preporučene ukupne volumene infuzija prema rasponu težine vidjeti Tablicu 1. Otopinu treba nježno promiješati i ne tresti.
English: ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: DODATAK II A. PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: Reported in ≥ 2 patients receiving KANUMA c Age at first dose: 1 to 6 months
Croatian: Dob pri primjeni prve doze: 1 do 6 mjeseci Tablica 2: Nuspojave zabilježene u djece i odraslih d koji su primali KANUMU
English: Chills, chest discomfort c,e
Croatian: Zimica, nelagoda u prsištu c,e
English: Very common Eyelid oedema
Croatian: makulopapularni osip
English: Very common Hypertension, pallor b
Croatian: Hipertenzija, bljedilob
English: Your doctor will decide how much medicine you will take and how often.
Croatian: Vaš će liječnik odlučiti koliko lijeka ćete uzimati i koliko često.
English: • Your asthma may get worse.
Croatian: • astma Vam se može pogoršati.
English: Date of latest renewal: 16 May 2018.
Croatian: Datum posljednje obnove odobrenja: 16. svibanj 2018.
English: • This medicine is usually given every day.
Croatian: • Ovaj lijek se obično daje svaki dan.
English: OHSS may progress rapidly (within 24 hours) or over several days to become a serious medical event.
Croatian: OHSS može brzo napredovati (u roku od 24 sata) ili u roku od nekoliko dana postati ozbiljan medicinski problem.
English: This medicine usually does not work if you have this problem.
Croatian: Ovaj lijek obično ne djeluje ako imate takav problem.
English: • The dose may be increased, depending on your response.
Croatian: • Doza se može povisiti ovisno o Vašem odgovoru.
English: It may be acceptable to extend the duration of stimulation in any one cycle to up to 5 weeks.
Croatian: Prihvatljivo je produljiti trajanje stimulacije u bilo kojem ciklusu do najviše 5 tjedana.
English: Men with too much FSH in their blood
Croatian: Muškarci s previše FSH u krvi
English: Please talk to your doctor as soon as you realise that you forgot a dose.
Croatian: Molimo obratite se liječniku čim shvatite da ste zaboravili dozu.
English: Proper treatment of your condition, however, requires close and constant co-operation with your doctor.
Croatian: Ispravno liječenje Vašeg stanja, međutim, zahtjeva blisku i neprekidnu suradnju s liječnikom.
English: Benzyl alcohol may cause allergic reactions.
Croatian: Benzilni alkohol može izazvati alergijske reakcije.
English: This usually takes about 10 days but can take any time between 5 and 20 days.
Croatian: Za to je obično potrebno oko 10 dana, ali može biti potrebno od 5 do 20 dana.
English: This gets your eggs ready for collection.
Croatian: Vaša jajašca postaju spremna za prikupljanje.
English: However, it should be taken into account that there are variations between LH measurements performed in different laboratories.
Croatian: Međutim, potrebno je uzeti u obzir da postoje razlike između mjerenja LH provedenih u različitim laboratorijima.
English: The doses described below are stated in International Units (IU).
Croatian: Doze opisane u nastavku izražene su u međunarodnim jedinicama (IU).
English: If you are a man, having too much natural FSH in your blood can be a sign of damaged testicles.
Croatian: Ako ste muškarac, previše prirodnog FSH u Vašoj krvi može biti znak oštećenja testisa.
English: Differences between the 2 groups were statistically significant (p < 0.05) for all criteria listed.
Croatian: Razlike između 2 skupine bile su statistički značajne (p < 0,05) za sva navedena mjerila.
English: • Treatment is continued until your eggs have developed to a desired point.
Croatian: • Liječenje se nastavlja sve dok se jajašca ne razviju do željene točke.
English: What the recommended dose is
Croatian: Koja je preporučena doza
English: Multiple pregnancy may lead to medical complications for you and your babies.
Croatian: Višeplodne trudnoće mogu dovesti do medicinskih komplikacija kod Vas i Vaše djece.
English: All strengths listed above contain the other ingredients.
Croatian: Sve gore navedene jačine sadrže ove druge sastojke.
English: The first injection should be performed under direct medical supervision.
Croatian: Prvu injekciju treba dati pod izravnim medicinskim nadzorom.
English: Children and adolescents This medicine is not indicated for use in children and adolescents less than 18 years of age.
Croatian: Ovaj lijek nije indiciran za primjenu u djece i adolescenata mlađih od 18 godina.
English: • you have difficulty in breathing.
Croatian: • otežano dišete.
English: • primary testicular insufficiency.
Croatian: • primarne testikularne insuficijencije.
English: Tell your doctor before you start treatment, if you or any member of your family have porphyria.
Croatian: Obavijestite svog liječnika prije nego što počnete s liječenjem ako Vi ili neki član Vaše obitelji imate porfiriju.
English: Do not use this medicine if any of the above applies to you.
Croatian: Nemojte primjenjivati ovaj lijek ako se nešto od gore navedenog odnosi na Vas.
English: You may be told not to have sex or to use a barrier contraceptive method for at least 4 days.
Croatian: Možda će Vam reći da se suzdržite od spolnog odnosa ili da koristite kontracepcijsku metodu barijere tijekom najmanje 4 dana.
English: It is advised to adhere to the recommended starting doses indicated below.
Croatian: Savjetuje se pridržavati se niže navedenih preporučenih početnih doza.
English: Deterioration or a first appearance of this condition may require cessation of treatment.
Croatian: Pogoršanje ili prvi znakovi tog stanja mogu zahtijevati prestanak liječenja.
English: It most often occurs after hormonal treatment has been discontinued and reaches its maximum at about 7 to 10 days following treatment.
Croatian: Najčešće nastaje nakon što se prekine hormonsko liječenje i postiže vrhunac oko 7 do 10 dana nakon liječenja.
English: Talk to your doctor straight away if:
Croatian: Odmah se obratite svom liječniku ako:
English: If you are a woman, this medicine increases your risk of developing OHSS.
Croatian: Ako ste žena, ovaj Vam lijek povećava rizik od razvoja OHSS.
English: • you get pain in the lower part of the abdomen (belly),
Croatian: • osjetite bol u donjem dijelu abdomena (trbuha),
English: In adult men
Croatian: U odraslih muškaraca
English: Your doctor or nurse will show you how to inject the medicine.
Croatian: Liječnik ili medicinska sestra pokazat će Vam kako da ubrizgate lijek.
English: Overall experience with IVF indicates that in general the treatment success rate remains stable during the first four attempts and gradually declines thereafter.
Croatian: Cjelokupno iskustvo s IVF pokazuje da stopa uspješnog liječenja općenito ostaje stabilna tijekom prva četiri pokušaja, a nakon toga postupno opada.
English: However, since Ovaleap is not indicated in pregnancy, these data are of limited clinical relevance.
Croatian: Međutim, budući da Ovaleap nije indiciran u trudnoći, ovi podaci imaju ograničenu kliničku važnost.
English: If you are developing OHSS your doctor may not give you any hCG in this treatment cycle.
Croatian: Ako razvijate OHSS, liječnik Vam možda uopće neće dati hCG u ovom ciklusu liječenja.
English: Following subcutaneous administration, the absolute bioavailability is about 70 %.
Croatian: Nakon supkutane primjene, apsolutna bioraspoloživost je oko 70%.
English: The very first injection of this medicine should only be given in the presence of a doctor or nurse.
Croatian: Prvu injekciju ovog lijeka treba dati samo u prisutnosti liječnika ili medicinske sestre.
English: No teratogenic effect has been observed in animal studies (see section 5.3).
Croatian: Nije opažen teratogeni učinak u ispitivanjima na životinjama (vidjeti dio 5.3).
English: Each cartridge must be used by a single patient only.
Croatian: Jedan uložak smije koristiti samo jedan pacijent.
English: • You will use these two medicines three times a week for at least 4 months.
Croatian: • Primjenjivat ćete ova dva lijeka tri puta tjedno tijekom najmanje 4 mjeseca.
English: • your skin becomes fragile and easily blistered, especially skin that has been frequently in the sun, and/or
Croatian: • ako Vam koža postane krhka i lako nastaju mjehurići, osobito na koži koja je često izložena suncu, i/ili
English: Semen analysis is recommended 4 to 6 months after the beginning of treatment as part of the assessment of the response.
Croatian: Analiza sjemena preporučuje se 4 do 6 mjeseci nakon početka liječenja u sklopu procjene odgovora.
English: Ovaleap must not be used when an effective response cannot be obtained, such as:
Croatian: Ovaleap se ne smije primjenjivati kad se ne može dobiti učinkovit odgovor, kao kod:
English: • You will use these two medicines each day for up to 5 weeks.
Croatian: • Primjenjivat ćete ta dva lijeka svakog dana do najviše 5 tjedana.
English: Your doctor or nurse will give you instructions on how to do this and you can also find instructions in the separate instructions for use of the pen.
Croatian: Liječnik ili medicinska sestra dat će Vam upute kako da to učinite, a upute možete pronaći i u zasebnim Uputama za uporabu brizgalice.
English: If you administer this medicine to yourself, please carefully read and follow the “Instructions for Use” of the pen.
Croatian: Ako lijek dajete sami sebi, pažljivo pročitajte i slijedite „Upute za uporabu“ brizgalice.
English: It should be noted however that pregnancy itself as well as OHSS also carry an increased risk of thromboembolic events.
Croatian: Međutim, treba naglasiti da sama trudnoća, kao i OHSS, također nose povišeni rizik od trombo-embolijskih događaja.
English: • if you are a man with: - testicular failure that is not treatable.
Croatian: • ako ste muškarac koji ima: - zatajenje testisa koje se ne može izliječiti.
English: If you think you are having this type of reaction, you must stop your Ovaleap injection and get medical help immediately.
Croatian: Ako mislite da imate ovu vrstu reakcije, morate prekinuti primjenu injekcija Ovaleapa i odmah zatražiti medicinsku pomoć.
English: The maximum daily dose is 450 IU.
Croatian: Najviša dnevna doza je 450 IU.
English: • If you have not responded to treatment after 4 months, your doctor may suggest that you continue using these two medicines for at least 18 months.
Croatian: • Ako niste odgovorili na liječenje nakon 4 mjeseca, liječnik Vam može predložiti da nastavite primjenjivati ova dva lijeka najmanje 18 mjeseci.
English: Special population
Croatian: Posebna populacija
English: • Swelling of the veins above and behind the testicles (a varicocele)
Croatian: • otečenost vena iznad i iza testisa (varikokela)
English: Self-administration should only be performed by patients who are well motivated, adequately trained and have access to expert advice.
Croatian: Injekcije smiju sami sebi davati samo pacijenti koji su dobro motivirani, prikladno obučeni i imaju pristup stručnom savjetu.
English: • malformations of sexual organs incompatible with pregnancy;
Croatian: • malformacija spolnih organa nespojivih s trudnoćom;
English: In men, FSH is needed for the production of sperm.
Croatian: U muškaraca, FSH je potreban za stvaranje sperme.
English: FSH is a gonadotropin, a type of hormone that plays an important role in human fertility and reproduction.
Croatian: FSH je gonadotropin, vrsta hormona koja igra važnu ulogu u plodnosti i reprodukciji kod ljudi.
English: Since these patients are amenorrhoeic and have low endogenous oestrogen secretion, treatment can commence at any time.
Croatian: Budući da ove pacijentice imaju amenoreju i nisko lučenje endogenog estrogena, liječenje može započeti u bilo kojem trenutku.
English: If you need to develop several eggs for collection prior to any assisted reproductive technology
Croatian: Ako trebate razviti nekoliko jajašaca za prikupljanje prije neke metode potpomognute oplodnje
English: There is evidence to suggest that hCG plays a key role in triggering OHSS and that the syndrome may be more severe and more protracted if pregnancy occurs.
Croatian: Postoje dokazi koji pokazuju da hCG igra ključnu ulogu u poticanju nastanka OHSS i da taj sindrom može biti teži i trajati dulje ako nastupi trudnoća.
English: In general adequate follicular development is achieved on average by the tenth day of treatment (range 5 to 20 days).
Croatian: Općenito se odgovarajući razvoj folikula prosječno postiže do desetog dana liječenja (raspon, 5 do 20 dana).
English: As the multidose cartridge is intended for several injections, clear instructions should be provided to the patients to avoid misuse of the medicine.
Croatian: Budući da je uložak za više doza namijenjen za nekoliko injekcija, pacijentima treba dati jasne upute kako da izbjegnu krivu uporabu višedoznog oblika lijeka.
English: This is a condition that may be passed on from parents to children which means that you have an inability to break down porphyrins (organic compounds).
Croatian: To je stanje koje dijete može naslijediti od roditelja, a znači da ne možete razgraditi porfirine (organske spojeve).
English: Mild or moderate OHSS has been commonly reported and should be considered as an intrinsic risk of the stimulation procedure.
Croatian: Blagi ili umjereni OHSS često je zabilježen i treba ga smatrati intrinzičnim rizikom postupka stimulacije.
English: If you are not ovulating and if the recommended dose and timing are followed, the occurrence of OHSS is less likely.
Croatian: Ako ne ovulirate i ako se pridržavate preporučene doze i rasporeda primjene, manja je vjerojatnost nastanka OHSS.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 September 2013.
Croatian: Datum prvog odobrenja: 27. rujna 2013.
English: Then Ovaleap is given approximately 2 weeks after the start of agonist treatment.
Croatian: Potom se Ovaleap daje približno 2 tjedna nakon početka liječenja agonistom.
English: If you are not sure, talk to your doctor or pharmacist before using this medicine.
Croatian: Ako niste sigurni, obratite se svom liječniku ili ljekarniku prije primjene ovog lijeka.
English: If your doctor decides to try Ovaleap treatment, they may monitor it by asking you to provide semen for analysis 4 to 6 months after starting treatment.
Croatian: Ako Vaš liječnik odluči pokušati s liječenjem Ovaleapom, može pratiti liječenje tako što će od Vas tražiti da date uzorak sjemena za analizu 4 do 6 mjeseci nakon početka liječenja.
English: There is no indication for use of Ovaleap during pregnancy.
Croatian: Nema indikacije za primjenu Ovaleapa tijekom trudnoće.
English: Therefore, patients should be followed for at least 2 weeks after hCG administration.
Croatian: Stoga je pacijentice potrebno pratiti najmanje 2 tjedna nakon primjene hCG.