FrancophonIA/ELRC3.0 huggingface dataset:
English: No data on acute toxicity of Fertavid in humans is available, but the acute toxicity of Fertavid and of urinary gonadotrophin preparations in animal studies has been shown to be very low.
Croatian: Nema dostupnih podataka o akutnoj toksičnosti lijeka Fertavid u ljudi, ali je u istraživanjima na životinjama pokazano da je akutna toksičnost lijeka Fertavid i urinarnih gonadotropina vrlo niska.
English: The first injection with Fertavid should be performed under direct medical supervision.
Croatian: Prva injekcija lijeka Fertavid mora se dati pod neposrednim medicinskim nadzorom.
English: • have high prolactin levels in the blood (hyperprolactinemia)
Croatian: • ako imate visoke razine prolaktina u krvi (hiperprolaktinemija)
English: Due to the relatively long elimination half-life, repeated administration of the same dose will lead to plasma concentrations of FSH that are approximately 1.5-2.5 times higher than after single dose administration.
Croatian: Zbog relativno dugog poluvremena eliminacije, ponovljena primjena iste doze dovest će do koncentracija FSH-a u plazmi koje su oko 1,5 do 2,5 puta veće nego nakon primjene jedne doze.
English: Early OHSS usually occurs within 10 days after hCG administration and may be associated with an excessive ovarian response to gonadotropin stimulation.
Croatian: Rani OHSS obično nastaje unutar 10 dana nakon primjene hCG-a i može biti povezan s prekomjernim odgovorom jajnika na stimulaciju gonadotropinima.
English: In these women the benefits of gonadotropin administration, including Fertavid, need to be weighed against the risks.
Croatian: U tih žena potrebno je odvagnuti koristi primjene gonadotropina, uključujući Fertavid, u odnosu na rizike.
English: Your doctor may also check blood hormone levels.
Croatian: Vaš liječnik Vam također može provjeriti razine hormona u krvi.
English: To check the effects of treatment, your doctor may ask you for a semen sample to be analysed, four to six months after the start of treatment.
Croatian: Kako bi provjerio učinak liječenja, liječnik može zatražiti analizu uzorka sjemena 4 do 6 mjeseci nakon početka liječenja.
English: After treatment with gonadotrophin preparations, there is an increased chance of having multiple pregnancies, even when only one embryo is transferred into the uterus.
Croatian: Nakon liječenja preparatima gonadotropina povećava se vjerojatnost višeplodne trudnoće, čak i kad se u maternicu prenese samo jedan zametak.
English: Furthermore, multiple pregnancies and characteristics of the patients undergoing fertility treatment (e.g. age of the female, sperm characteristics, genetic background of both parents) may be associated with an increased risk of birth defects.
Croatian: Osim toga, višeplodne trudnoće kao i posebne osobine bolesnika koji se liječe od neplodnosti (npr. dob žene, osobine sperme, genetsko nasljeđe oba roditelja) mogu biti povezane s povećanim rizikom od prirođenih mana.
English: Antibiotic hypersensitivity reactions
Croatian: Reakcije preosjetljivosti na antibiotike
English: There are no significant pharmacokinetic differences between intramuscular and subcutaneous administration of Fertavid.
Croatian: Nema značajnih farmakokinetičkih razlika između intramuskularne i supkutane primjene lijeka Fertavid.
English: Single-dose administration of Fertavid to rats induced no toxicologically significant effects.
Croatian: Primjena jedne doze lijeka Fertavid u štakora nije izazvala značajne toksikološke učinke.
English: The very first injection of Fertavid should only be given in the presence of a doctor or nurse.
Croatian: Prva injekcija lijeka Fertavid smije se dati samo u prisustvu liječnika ili medicinske sestre.
English: • blockage in your lungs (pulmonary embolus)
Croatian: • začepljenje u plućima (plućna embolija)
English: Children There is no relevant use of Fertavid in children.
Croatian: Djeca Nema relevantne primjene lijeka Fertavid u djece.
English: To find the right dosage, your doctor will check your follicle growth by means of ultrasound scanning, and measurement of the amount of oestradiol (female sex hormone) in the blood.
Croatian: Kako bi odredio pravilnu dozu, Vaš liječnik će provjeravati rast folikula ultrazvukom i mjerenjem količine estradiola (ženskog spolnog hormona) u krvi.
English: Fertavid is unlikely to affect your ability to drive or use machines.
Croatian: Nije vjerojatno da će Fertavid utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
English: • Fertavid may contain traces of streptomycin and/or neomycin.
Croatian: • Fertavid može sadržavati streptomicin i/ili neomicin u tragovima.
English: Pull the syringe out quickly and apply pressure to the injection site with a swab containing disinfectant.
Croatian: Štrcaljku izvucite brzo i pritisnite mjesto uboda vatom s dezinfekcijskim sredstvom.
English: Injections may be given slowly into a muscle (for instance in the buttock, upper leg or upper arm) or under the skin (in the lower stomach, for example).
Croatian: Injekcija se daje polako, ili u mišić (na primjer u stražnjicu, bedro ili nadlakticu), ili pod kožu (na primjer u donjem dijelu trbuha).
English: When given under the skin the injection may, in some cases, be given by yourself or your partner.
Croatian: Ako se injicira pod kožu, u nekim slučajevima injekciju si možete dati sami, ili Vam je može dati partner/partnerica.
English: Follow current clinical practice for reducing the risk of OHSS during Assisted Reproductive Technology (ART).
Croatian: Potrebno je slijediti trenutačnu kliničku praksu za smanjenje rizika od OHSS-a tijekom postupka potpomognute oplodnje (engl.
English: Women with known risk factors for a high ovarian response may be especially prone to the development of OHSS during or following treatment with Fertavid.
Croatian: Žene s poznatim rizičnim faktorima za jaki odgovor jajnika mogu biti posebno sklone razvoju OHSS-a tijekom ili nakon liječenja lijekom Fertavid.
English: Multiple gestation, especially high order, carries an increased risk of adverse maternal (pregnancy and delivery complications) and perinatal (low birth weight) outcomes.
Croatian: Višeplodna trudnoća, osobito s velikim brojem zametaka, nosi povećan rizik štetnih ishoda za majku (komplikacije tijekom trudnoće i porođaja) i plod (niska porođajna težina).
English: Talk to your doctor before using Fertavid if you:
Croatian: Obratite se svom liječniku prije nego primijenite Fertavid:
English: In women undergoing assisted reproduction techniques, including in vitro fertilisation (IVF) and other methods, Fertavid can bring about the development of multiple follicles.
Croatian: U žena koje su uključene u postupke medicinski potpomognute oplodnje, uključujući izvantjelesnu oplodnju (IVF) i druge metode, Fertavid može dovesti do razvoja većeg broja folikula.
English: Fertavid may affect milk production.
Croatian: Fertavid može utjecati na stvaranje mlijeka.
English: For anovulatory women undergoing ovulation induction, monitoring follicular development with transvaginal ultrasonography may aid in determining whether or not to continue the cycle in order to reduce the risk of multiple pregnancies.
Croatian: Kod žena s anovulacijskim ciklusima koje prolaze indukciju ovulacije, nadziranje razvoja folikula pomoću transvaginalnog ultrazvuka može pomoći da se odredi nastaviti ili ne s ciklusom kako bi se smanjio rizik od višeplodne trudnoće.
English: Depress the plunger slowly and steadily, so the solution is correctly injected and the skin tissues are not damaged.
Croatian: Polako i ravnomjerno potiskujte klip štrcaljke kako biste pravilno injicirali otopinu, a da ne oštetite kožno tkivo.
English: Your doctor will do ultrasound scans of your ovaries to carefully monitor the number of maturing follicles.
Croatian: Vaš liječnik će Vam pregledavati jajnike ultrazvukom kako bi pažljivo pratio broj sazrijevajućih folikula.
English: Ovarian response is monitored by ultrasound assessment.
Croatian: Odgovor jajnika prati se pomoću pregleda ultrazvukom.
English: Ovarian torsion may be associated with other risk factors such as OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovaries.
Croatian: Torzija jajnika mogla bi biti povezana s ostalim rizičnim faktorima kao što su OHSS, trudnoća, ranija operacija u abdomenu, torzija jajnika u anamnezi, postojeća ili ranija cista jajnika i policistični jajnici.
English: To monitor the risk of OHSS, ultrasonographic assessments of follicular development should be performed prior to treatment and at regular intervals during treatment; the concurrent determination of serum oestradiol levels may also be useful.
Croatian: Kako bi se pratio rizik od OHSS-a, potrebne su ultrazvučne procjene razvoja folikula prije liječenja i u redovitim vremenskim razmacima tijekom liječenja; istodobno određivanje koncentracije estradiola u serumu također može biti korisno.
English: You may regularly have ultrasound scans of the ovaries.
Croatian: Možda ćete obavljati redovne ultrazvučne preglede jajnika.
English: There is no information available from clinical or animal studies on the excretion of follitropin beta in milk.
Croatian: Nema podataka iz kliničkih ispitivanja ili istraživanja na životinjama o izlučivanju folitropina beta u majčino mlijeko.
English: Since follicles of over 14 mm may lead to pregnancies, multiple pre-ovulatory follicles exceeding 14 mm carry the risk of multiple gestations.
Croatian: Budući da folikuli veći od 14 mm omogućavaju trudnoću, veći broj folikula većih od 14 mm u predovulacijskoj fazi nosi rizik od višeplodne trudnoće.
English: Based on the results of comparative clinical studies, it is considered appropriate to give a lower total dosage of Fertavid over a shorter treatment period than generally used for urinary FSH, not only in order to optimise follicular development but also to reduce the risk of unwanted ovarian hyperstimulation (see section 5.1).
Croatian: Na temelju rezultata komparativnih kliničkih ispitivanja smatra se prikladnijim davati nižu ukupnu dozu lijeka Fertavid tijekom kraćeg razdoblja liječenja nego što je uobičajeno kod primjene urinarnog FSH-a, ne samo radi optimalnog razvoja folikula, nego i kako bi se smanjio rizik od neželjene hiperstimulacije jajnika (vidjeti dio 5.1).
English: Fertavid solution for injection (injection) is a clear, colourless liquid.
Croatian: Fertavid otopina za injekciju (injekcija) je bistra, bezbojna tekućina.
English: When used for an ovulation induction cycle, appropriate FSH dose adjustment(s) should prevent multiple follicle development.
Croatian: Kad se primjenjuje za indukciju ovulacijskog ciklusa, odgovarajuća prilagodba(e) doze FSH trebala bi spriječiti razvoj većeg broja folikula.
English: • Anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate.
Croatian: • Anovulacija (uključujući sindrom policističnih jajnika; engl. polycystic ovarian syndrome, PCOS) u žena koje nisu odgovorile na liječenje klomifen citratom.
English: Step 5 - Checking the correct needle position
Croatian: Korak 5 - Provjerite je li igla ispravno postavljena
English: Distribution, biotransformation and elimination Recombinant FSH is biochemically very similar to urinary human FSH and is distributed, metabolised, and excreted in the same way.
Croatian: Rekombinantni FSH biokemijski je vrlo sličan ljudskom urinarnom FSH pa se distribuira, metabolizira i izlučuje na isti način.
English: Too high a dosage of FSH may lead to hyperstimulation of the ovaries (see section 4.4).
Croatian: Previsoke doze FSH-a mogu izazvati hiperstimulaciju jajnika (vidjeti dio 4.4).
English: In women undergoing Assisted Reproduction Technologies (ART) procedures, the risk of a multiple pregnancy is mainly related to the number of embryos transferred.
Croatian: U žena koje prolaze postupke medicinski potpomognute oplodnje, rizik od višeplodne trudnoće većinom je povezan s brojem prenijetih embrija.
English: Elevated endogenous FSH levels in men are indicative of primary testicular failure.
Croatian: Povišene koncentracije endogenog FSH-a u muškaraca ukazuju na primarno zatajenje testisa.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2.)
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2)
English: This medicinal product contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po injekciji, tj. zanemarive količine natrija.
English: In particular, patients should be evaluated for hypothyroidism, adrenocortical insufficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given.
Croatian: Osobito, bolesnike treba pregledati na hipotireozu, adrenokortikalnu insuficijenciju, hiperprolaktinemiju i tumore hipofize ili hipotalamusa te primijeniti odgovarajuće specifično liječenje.
English: Using the pen, injections just under the skin (in the lower stomach, for example) can be given by yourself or your partner.
Croatian: Koristeći brizgalicu, injekciju neposredno pod kožu (na primjer u donji dio trbuha) si možete dati sami, ili Vam je može dati partner/partnerica.
English: Intramuscular (IM) and subcutaneous (SC) use The contents of the vial should be used immediately after piercing of the rubber stopper.
Croatian: Primjena intramuskularno (i.m.) ili supkutano (s.c.) Sadržaj bočice mora se upotrijebiti odmah nakon što se probije gumeni čep.
English: In women, FSH is needed for the growth and development of follicles in the ovaries.
Croatian: U žena je FSH potreban za rast i razvoj folikula u jajnicima.
English: If you: • are allergic to follitropin beta or any of the other ingredients of Fertavid (listed in section 6)
Croatian: • ako ste alergični na folitropin beta ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: OHSS may be caused by administration of human Chorionic Gonadotropin (hCG) and by pregnancy (endogenous hCG).
Croatian: OHSS može biti uzrokovan primjenom humanog korionskog gonadotropina (hCG) i trudnoćom (endogeni hCG).
English: • have heavy or irregular vaginal bleeding where the cause is unknown
Croatian: • ako imate jako ili nepravilno krvarenje iz rodnice nepoznatog uzroka
English: Pre-ovulatory conditions are reached when there is ultrasonographic evidence of a dominant follicle of at least 18 mm in diameter and/or when plasma oestradiol levels of 300-900 picograms/mL (1,000-3,000 pmol/L) are attained.
Croatian: Predovulacijski uvjeti su postignuti kad se ultrazvukom dokaže dominantni folikul promjera najmanje 18 mm i/ili kad koncentracija estradiola u plazmi dosegne 300-900 pikograma/ml (1000-3000 pmol/l).
English: Air bubbles must be removed from the cartridge before injection (see instructions for using the pen).
Croatian: Prije injiciranja iz uloška se moraju odstraniti mjehurići zraka (vidjeti upute za uporabu brizgalice).
English:  Contact your doctor immediately if you are experiencing stomach pains, or any of the other symptoms of ovarian hyperstimulation, also if this occurs some days after the last injection.
Croatian:  Odmah se javite liječniku ako osjetite bolove u trbuhu ili ako se pojavi neki drugi simptom hiperstimulacije jajnika, čak i ako se to dogodi nekoliko dana nakon posljednje injekcije.
English: In that case hCG should be withheld and pregnancy should be avoided in order to prevent multiple gestations.
Croatian: U tom slučaju se ne smije primijeniti hCG i mora se izbjeći trudnoća kako bi se spriječila višeplodna trudnoća.
English: Step 2 - The injection site
Croatian: Korak 2 - Mjesto injiciranja
English: The absolute bioavailability of subcutaneously administered Fertavid is approximately 77%.
Croatian: Apsolutna bioraspoloživost lijeka Fertavid nakon supkutane primjene iznosi oko 77%.
English: What you need to know before you use Fertavid
Croatian: Što morate znati prije nego počnete primjenjivati Fertavid
English: Ovarian overstimulation may develop into a medical condition called ovarian hyperstimulation syndrome (OHSS), which can be a serious medical problem.
Croatian: Prekomjerna stimulacija jajnika može prijeći u medicinsko stanje koje se zove sindrom hiperstimulacije jajnika (OHSS), što može predstavljati ozbiljan medicinski problem.
English: • have ever had stomach (abdominal) surgery
Croatian: • ako ste ikad imali kirurški zahvat u trbuhu (abdomenu)
English: • Fibroid tumours of the uterus incompatible with pregnancy.
Croatian: • Fibroidni tumori uterusa nespojivi s trudnoćom.
English: This is thought to be due to differences in parental characteristics (e.g., maternal age, sperm characteristics) and multiple gestations.
Croatian: Smatra se da su razlog tome razlike u osobinama roditelja (npr. dob majke, osobine sperme) kao i višeplodne trudnoće.
English: Fertavid has no or negligible influence on the ability to drive and use machines.
Croatian: Fertavid ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: OHSS causes fluid to build up suddenly in your stomach and chest areas and can cause blood clots to form.
Croatian: OHSS uzrokuje iznenadno nakupljanje tekućine u području trbuha i prsnog koša i može uzrokovati stvaranje krvnih ugrušaka.
English: Treatment with Fertavid is generally followed by administration of hCG to induce the final phase of follicle maturation, resumption of meiosis and rupture of the follicle.
Croatian: Nakon liječenja lijekom Fertavid obično slijedi primjena hCG-a kako bi se potaknula posljednja faza sazrijevanja folikula, ponovna uspostava mejoze i ruptura folikula.
English: Please put the day of first use of the cartridge on the dosing record table as shown in the Instruction Manual of the Puregon Pen.
Croatian: Zabilježite dan prve uporabe uloška u tablicu doziranja, kako je navedeno u Priručniku za uporabu brizgalice Puregon Pen.
English: There is a slightly increased risk of a pregnancy outside the uterus (an ectopic pregnancy).
Croatian: Postoji nešto povećan rizik od izvanmaternične trudnoće (ektopična trudnoća).
English: • have ovaries that do not work because of a condition called primary ovarian failure
Croatian: • ako Vam jajnici ne funkcioniraju zbog stanja koje se zove primarno zatajenje jajnika
English: The daily dose is then maintained until a follicle of proper size is present.
Croatian: Nakon toga se dnevna doza održava sve dok se ne uoči folikul odgovarajuće veličine.
English: Pregnancy complications
Croatian: Komplikacije trudnoće
English: • have malformations of the sexual organs which make a normal pregnancy impossible
Croatian: • ako imate nepravilnosti spolnih organa koje onemogućavaju normalnu trudnoću
English: This dose is continued for at least the first four days.
Croatian: Ta se doza daje najmanje prva četiri dana.
English: Do not use Fertavid after the expiry date which is stated on the label and carton after 'EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake "EXP".
English: These side effects are not considered to be related to the use of Fertavid, but to Assisted Reproductive Technology (ART) or subsequent pregnancy.
Croatian: Te se nuspojave ne smatraju povezanima s primjenom lijeka Fertavid nego s medicinski potpomognutom oplodnjom ili posljedičnom trudnoćom.
English: In rare cases, severe OHSS may be life-threatening.
Croatian: U rijetkim slučajevima, teški oblik OHSS-a može biti životno opasan.
English:  Regular monitoring of the response to FSH-treatment helps to prevent ovarian overstimulation.
Croatian:  Redovito praćenje odgovora na liječenje FSH-om pridonosi sprječavanju pretjerane stimulacije jajnika.
English: Fertavid can thus be used to stimulate follicular development and steroid production in selected cases of disturbed gonadal function.
Croatian: Fertavid se stoga može koristiti za stimulaciju folikularnog razvoja i proizvodnju steroida u određenim slučajevima poremećaja funkcije spolnih žlijezda.
English: follitropin beta (n = 105)
Croatian: folitropin beta (n = 105)
English: Rare side effects (may affect up to 1 in 1,000 people): - Blood clots (this may also occur in the absence of unwanted overstimulation of the ovaries, see warnings and precautions in section 2)
Croatian: Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba) - krvni ugrušci (mogu se javiti i bez neželjene pretjerane stimulacije jajnika, pogledajte upozorenja i mjere opreza u dijelu 2).
English: It is not established whether or not treatment with gonadotrophins increases the risk of these tumours in infertile women.
Croatian: Nije utvrđeno povećava li liječenje gonadotropinima rizik za razvoj tih tumora u neplodnih žena.
English: Congenital Malformations
Croatian: Prirođene malformacije
English: The starting dose is maintained for at least seven days.
Croatian: Početna se doza održava najmanje 7 dana.
English: In clinical studies comparing recFSH (follitropin beta) and urinary FSH for controlled ovarian stimulation in women participating in an assisted reproduction technology (ART) program and for ovulation induction (see tables 1 and 2 below), follitropin beta 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 uspoređivala primjena rekombinantnog FSH-a (folitropin beta) i urinarnog FSH-a za kontroliranu stimulaciju jajnika u žena uključenih u postupak medicinski potpomognute oplodnje i za poticanje ovulacije (vidjeti tablice 1 i 2 u nastavku), folitropin beta se pokazao potentnijim od urinarnog FSH-a u smislu manje ukupne doze i kraćeg trajanja liječenja potrebnog za poticanje folikularnog sazrijevanja.
English: Do not use this solution.
Croatian: Ne smijete upotrijebiti tu otopinu.
English: The daily dose is then maintained until pre-ovulatory conditions are reached.
Croatian: Ta se dnevna doza zatim održava do postizanja predovulacijskih uvjeta.
English: In more severe cases symptoms may include enlargement of the ovaries, accumulation of fluid in the abdomen and/or chest (which may cause sudden weight gain due to fluid buildup) and the occurrence of blood clots in the circulation.
Croatian: U težim slučajevima simptomi mogu uključivati povećanje jajnika, nakupljanje tekućine u trbuhu i/ili prsnom košu (što može uzrokovati iznenadno povećanje tjelesne težine zbog nakupljanja tekućine) i nastanak krvnih ugrušaka u cirkulaciji.
English: A sequential treatment scheme is recommended starting with daily administration of 50 IU Fertavid.
Croatian: Preporučuje se postupna shema liječenja koja počinje primjenom 50 IU lijeka Fertavid na dan.
English: No teratogenic effect has been observed in animal studies.
Croatian: Istraživanja na životinjama nisu pokazala teratogene učinke.
English: If you inject yourself with Fertavid, follow the instructions carefully to give Fertavid properly and with minimal discomfort.
Croatian: Ako sami injicirate Fertavid, pažljivo slijedite upute kako biste Fertavid primijenili pravilno i uz minimalnu nelagodu.
English: • Before starting treatment, the couple's infertility should be assessed as appropriate.
Croatian: • Prije početka liječenja potrebno je na odgovarajući način procijeniti plodnost para.
English: These are considered to be related to ART or subsequent pregnancy.
Croatian: Smatraju se povezanima s medicinski potpomognutom oplodnjom ili posljedičnom trudnoćom.
English: Once the rubber inlay of a cartridge is pierced by a needle, the product may be stored for a maximum of 28 days.
Croatian: Nakon što se iglom probije gumeni umetak uloška, lijek se smije čuvati najdulje 28 dana.
English: This dose is continued for at least seven days.
Croatian: Ta se doza daje najmanje sedam dana.
English: After intramuscular administration of Fertavid, the maximum FSH concentrations are higher and reached earlier in men as compared to women.
Croatian: Nakon intramuskularne primjene lijeka Fertavid maksimalne koncentracije FSH-a su veće i postižu se brže u muškaraca nego u žena.