FrancophonIA/ELRC3.0 huggingface dataset:
English: However, it should be taken into account that there are variations between LH measurements performed in different laboratories.
Croatian: Međutim, treba uzeti u obzir da postoje varijacije između mjerenja LH provedenim u različitim laboratorijima.
English: Wash your hands and find a clean area
Croatian: Operite ruke i pronađite čistu površinu
English: Do not touch the needle and do not allow the needle to touch any surface.
Croatian: Ne dirajte iglu i nemojte dopustiti da igla dodirne bilo koju površinu.
English: Multiple pregnancy may lead to medical complications for you and your babies.
Croatian: Višeplodne trudnoće mogu uzrokovati medicinske komplikacije za Vas i Vašu bebu.
English: EXP Shelf-life after first use: 28 days
Croatian: EXP EXP nakon prve primjene: 28 dana
English: •Wash your hands with soap and water.
Croatian: •Operite ruke vodom i sapunom.
English: Your doctor will decide how much medicine you will take and how often.
Croatian: Vaš će liječnik odlučiti koliko lijeka trebate uzimati i koliko često.
English: OHSS may progress rapidly (within 24 hours) or over several days to become a serious medical event.
Croatian: OHSS može brzo napredovati (unutar 24 sata) ili čak nekoliko dana te prerasti u teško medicinsko stanje.
English: • Give yourself the injection at the same time each day.
Croatian: • Injekciju si dajte svakog dana u isto vrijeme.
English: See the “Instructions for Use”.
Croatian: Vidjeti „Upute za uporabu“.
English: It most often occurs after hormonal treatment has been discontinued and reaches its maximum at about seven to ten days following treatment.
Croatian: Najčešće se događa nakon prekida hormonskog liječenja i doseže svoj maksimum otprilike 7 do 10 dana nakon liječenja.
English: Do not inject directly into a vein.
Croatian: Ne injicirajte izravno u venu.
English: Gonadotropins are involved in reproduction and fertility.
Croatian: Gonadotropini sudjeluju u reprodukciji i plodnosti.
English: An example of a treatment diary:
Croatian: Primjer dnevnika liječenja:
English: • Record the treatment day number (1), date (2) and time (3) of your injection.
Croatian: • Zabilježite broj dana liječenja (1), datum (2) i vrijeme (3) davanja injekcije.
English: • GONAL-f is usually given every day.
Croatian: • GONAL-f obično se daje svaki dan.
English: The medicine must be administered immediately after preparation.
Croatian: Lijek se mora primijeniti odmah nakon pripreme.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Date of latest renewal: 20 October 2010.
Croatian: Datum posljednje obnove odobrenja: 20. listopada 2010.
English: Put it aside for later use.
Croatian: Odložite ga sa strane za kasniju uporabu.
English: Differences between the 2 groups were statistically significant (p< 0.05) for all criteria listed.
Croatian: Razlike između 2 grupe bile su statistički značajne (p< 0,05) za sve navedene kriterije.
English: • Before starting the preparation, please read these instructions the whole way through first.
Croatian: • Prije početka pripreme prvo pročitajte ove upute u cijelosti.
English: Dose (IU)
Croatian: Doza (IU)
English: Not provided in the pack:
Croatian: U pakiranju se ne nalaze:
English: The prepared solution is for your use alone and must not be given to other patients.
Croatian: Pripremljena otopina namijenjena je samo za Vas i ne smije se davati drugim pacijentima.
English: Any unused solution must be discarded not later than 28 days after first opening.
Croatian: Sva neiskorištena otopina mora se baciti najkasnije 28 dana nakon prvog otvaranja.
English: Warning: Do not attach the needle too tightly; the needle could be difficult to remove after the injection.
Croatian: Upozorenje: Nemojte prečvrsto spojiti iglu; iglu će možda biti teško ukloniti nakon injekcije.
English: The next injection should be done at the same time the next day.
Croatian: Sljedeću je injekciju potrebno dati u isto doba sljedećeg dana.
English: Due to a local reactivity to benzyl alcohol, the same site of injection should not be used on consecutive days.
Croatian: Zbog lokalne reaktivnosti na benzilni alkohol isto mjesto uboda injekcije ne bi se trebalo upotrebljavati nekoliko dana zaredom.
English: A treatment diary is included on the last page.
Croatian: Dnevnik liječenja nalazi se na zadnjoj stranici.
English: Do not use GONAL-f if any of the above applies to you.
Croatian: Nemojte uzimati GONAL-f ako se bilo što od gore navedenog odnosi na Vas.
English: Studies have shown that these two medicines can be mixed and injected together, without either product being adversely affected.
Croatian: Studije su pokazale da se ova dva lijeka mogu miješati i zajedno injicirati bez negativnih utjecaja na bilo koji od tih lijekova.
English: It is not expected that this medicine will affect your ability to drive and use machines.
Croatian: Ne očekuje se da će ovaj lijek utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: If the peel-off seal is damaged or loose, do not use the needle.
Croatian: Ako je odvojiva folija oštećena ili odlijepljena, nemojte koristiti tu iglu.
English: If you do not have periods you can start using the medicine on any convenient day.
Croatian: Ako menstruacija izostaje, možete početi uzimati lijek bilo koji odgovarajući dan.
English: Please talk to your doctor as soon as you notice that you forgot a dose.
Croatian: Obratite se svojem liječniku odmah kada primijetite da ste zaboravili primijeniti dozu.
English: Days of FSH stimulation required 11.7 ± 1.9
Croatian: Broj dana potrebnih za stimulaciju s FSH 11,7 ± 1,9
English: It should be noted however that pregnancy itself as well as OHSS also carry an increased risk of thromboembolic events.
Croatian: No, također treba imati na umu da trudnoća, sama po sebi, baš kao i OHSS, također donosi povećani rizik od tromboembolijskih događaja.
English: Deterioration or a first appearance of this condition may require cessation of treatment.
Croatian: Pogoršanje ili pojava prvih simptoma te bolesti može zahtijevati prekid terapije.
English: • You will use these two medicines each day for up to five weeks.
Croatian: • Ta ćete 2 lijeka primjenjivati svakog dana najviše 5 tjedana.
English: No teratogenic effect has been observed in animal studies (see section 5.3).
Croatian: U ispitivanjima na životinjama nije opažen teratogeni učinak (vidjeti dio 5.3).
English: The product must be discarded if it has not been used after 3 months.
Croatian: Lijek je potrebno baciti ako se ne upotrijebi nakon 3 mjeseca.
English: Therefore patients should be followed for at least two weeks after hCG administration.
Croatian: Pacijentice stoga treba pratiti najmanje 2 tjedna nakon primjene hCG-a.
English: Get a new needle.
Croatian: Uzmite novu iglu.
English: In general adequate follicular development is achieved on average by the tenth day of treatment (range 5 to 20 days).
Croatian: Općenito, adekvatni razvoj folikula postiže se prosječno 10. dan terapije (raspon je od 5 do 20 dana).
English: If you use more GONAL-f than you should
Croatian: Ako primijenite više GONAL-f nego što ste trebali
English: Warning: Always make sure to use a new needle for each injection.
Croatian: Upozorenje: Pazite da za svaku injekciju uvijek koristite novu iglu.
English: Tell your doctor straight away if:
Croatian: Odmah obavijestite svog liječnika ako primijetite sljedeće:
English: Following subcutaneous administration, the absolute bioavailability is about 70 %.
Croatian: Nakon supkutane primjene, apsolutna bioraspoloživost iznosi oko 70%.
English: If you forget to use GONAL-f, do not take a double dose to make up for a forgotten dose.
Croatian: Ako zaboravite primijeniti GONAL-f, nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Store in a refrigerator (2°C-8°C).
Croatian: Čuvati u hladnjaku (2 °C-8 °C).
English: • You will use these two medicines three times a week for at least 4 months.
Croatian: • Ta ćete 2 lijeka primjenjivati 3 puta tjedno najmanje 4 mjeseca.
English: This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and multiple pregnancies.
Croatian: Smatra se da je to posljedica razlika u karakteristikama roditelja (na primjer: dob majke, karakteristike sperme) i višeplodnih trudnoća.
English: • 1 needle for preparation
Croatian: • 1 iglu za pripremu
English: Warning: Medicine should not be disposed of via wastewater or household waste.
Croatian: Upozorenje: Lijek se ne smije uklanjati putem otpadnih voda ili kućnog otpada.
English: • Carefully remove and discard the green inner shield.
Croatian: • Pažljivo uklonite i bacite zeleni unutarnji štitnik.
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 ne odgovorite na liječenje nakon 4 mjeseca, liječnik će Vam možda predložiti da nastavite primjenjivati ta 2 lijeka najmanje 18 mjeseci.
English: In these women, the benefits of gonadotropin administration need to be weighed against the risks.
Croatian: U ovih žena dobrobiti primjene gonadotropina treba usporediti s rizicima.
English: However, since GONAL-f is not indicated in pregnancy, these data are of limited clinical relevance.
Croatian: No budući da GONAL-f nije indiciran u trudnoći, ovi podaci imaju ograničeni klinički značaj.
English: After the powder has dissolved (which usually occurs immediately), check that the resulting solution is clear and does not contain any particles.
Croatian: Kada se prašak otopi (što se obično događa odmah) provjerite je li dobivena otopina bistra te da ne sadrži nikakve čestice.
English: Treatment Day Number
Croatian: Broj dana liječenja
English: • If you administer GONAL-f to yourself, please carefully read and follow the “Instructions for
Croatian: • Ako si sami dajete GONAL-f, molimo Vas pažljivo pročitajte i slijedite „Upute za uporabu“.
English: Semen analysis is recommended 4 to 6 months after the beginning of treatment as part of the assessment of the response.
Croatian: Preporučeno je analizirati sjeme 4 do 6 mjeseci nakon početka terapije, što je dio procjene odgovora na terapiju.
English: • Inject under the skin by pushing gently the plunger, as you were taught.
Croatian: • Injicirajte pod kožu polaganim pritiskom klipa, kao što su Vas naučili.
English: Push the plunger until the air bubbles are gone.
Croatian: Pogurajte klip sve dok ne nestanu mjehurići zraka.
English: 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.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti pojedinačnih i ponovljenih doza i genotoksičnosti pored onih navedenih u drugim dijelovima ovog Sažetka.
English: • primary testicular insufficiency
Croatian: • primarna insuficijencija testisa
English: • GONAL-f dose may be increased, depending on your response.
Croatian: • Doza lijeka GONAL-f može se povećati, što ovisi o Vašem odgovoru.
English: Set the dose that was prescribed by your doctor (in the example shown in the figure, it is 50 IU).
Croatian: 5.3 Podesite dozu koju Vam je propisao liječnik (u primjeru sa slike, to je 50 IU).
English: Using your treatment diary to record your daily injection(s) allows you to verify every day that you received the full prescribed dose.
Croatian: Dnevnik liječenja u koji zapisujete dnevnu injekciju (dnevne injekcije) omogućuje vam da svaki dan provjerite jeste li primili cijelu propisanu dozu.
English: Since these patients are amenorrhoeic and have low endogenous oestrogen secretion, treatment can commence at any time.
Croatian: Budući da ove pacijentice pate od amenoreje i imaju slabo lučenje endogenog estrogena, terapija se može započeti u bilo kojem trenutku.
English: For accurate interpretation of the indices of follicle development and maturation, the physician should be experienced in the interpretation of the relevant tests.
Croatian: Kako bi točno tumačio indekse razvoja i sazrijevanja folikula, liječnik mora imati određeno iskustvo u interpretaciji relevantnih testova.
English: • When the pen is empty, ask your pharmacist how to dispose of it.
Croatian: • Kada se brizgalica isprazni, upitajte svojeg ljekarnika kako je baciti.
English: Take as much time as you need to inject all the solution.
Croatian: Dajte si koliko god Vam je vremena potrebno da injicirate svu otopinu.
English: This could cause chest pain, breathlessness, stroke or heart attack (see also in section 2. under “Blood clotting problems”).
Croatian: To može uzrokovati bol u prsnom košu, nedostatak zraka, moždani ili srčani udar (pogledajte također u dijelu 2. pod "Problemi sa zgrušavanjem krvi").
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: Sveukupno iskustvo s umjetnom oplodnjom upućuje na to da, općenito, stopa uspješnosti terapije ostaje jednak prilikom prva 4 pokušaja, a potom se postupno smanjuje.
English: The following table states the volume to be administered to deliver the prescribed dose:
Croatian: U sljedećoj su tablici navedeni volumeni koji se trebaju primijeniti da bi se u organizam unijela propisana doza:
English: Mild or moderate OHSS (including associated symptomatology)
Croatian: Blagi ili umjereni OHSS (uključujući povezanu simptomatologiju)
English: If you are developing OHSS your doctor may not give you any hCG in this treatment cycle and you may be told not to have sex or to use a barrier contraceptive method for at least four days.
Croatian: Ako počinjete razvijati OHSS, liječnik Vam možda neće dati hCG u tom ciklusu liječenja te će Vas uputiti da se suzdržavate od spolnih odnosa ili koristite barijernu metodu kontracepcije najmanje četiri dana.
English: Men with hypogonadotrophic hypogonadism
Croatian: Muškarci s hipogonadotropnim hipogonadizmom
English: • Your dose of GONAL-f may be increased every 7 or every 14 days by 37.5 to 75 IU, until you get the desired response.
Croatian: • Vaše doziranje lijeka GONAL-f može se povećati svakih 7 ili 14 dana za 37,5 do 75 IU, sve dok ne postignete željeni odgovor.
English: Weight gain
Croatian: Dobivanje na težini
English: • you have stomach, arm or leg pain.
Croatian: • ako imate bolove u trbuhu, rukama ili nogama.
English: Your doctor will use blood tests and/or an ultrasound machine to check when this is.
Croatian: Vaš će liječnik pomoću pretraga krvi i ultrazvuka provjeriti kada je to.
English: Studies have shown that co-administration with lutropin alfa, does not significantly alter the activity, stability, pharmacokinetic nor pharmacodynamic properties of the active substances.
Croatian: Studije su pokazale da istovremena primjena s lutropinom alfa znatno ne mijenja djelovanje, stabilnost, farmakokintetička ni farmakodinamička svojstva djelatnih tvari.
English: Monitoring of stimulation cycles by ultrasound scans as well as oestradiol measurements are recommended to early identify risk factors.
Croatian: Praćenje ciklusa stimulacije pregledima ultrazvukom i mjerenjima estradiola preporučuje se za rano prepoznavanje faktora rizika.
English: • malformations of sexual organs incompatible with pregnancy
Croatian: • malformacija spolnih organa koje su nespojive s trudnoćom
English: • Your doctor or nurse will show you how to inject GONAL-f before you can inject yourself.
Croatian: • Vaš liječnik ili medicinska sestra pokazat će Vam kako se injicira GONAL-f prije nego što ga možete sami injicirati.
English: Volume to be injected (mL)
Croatian: Volumen za injiciranje (ml)
English: Appearance of the powder: white lyophilised pellet.
Croatian: Izgled praška: bijeli liofilizirani pelet.
English: Total dose of FSH required (number of FSH 75 IU ampoules)
Croatian: Ukupni broj potrebnih FSH doza (broj FSH 75 IU ampula)
English: Contents of the pack and other information Instructions for Use.
Croatian: Sadržaj pakiranja i druge informacije Upute za uporabu
English: The injection site should be alternated daily.
Croatian: Mjesto injiciranja treba mijenjati svakog dana.
English: • Swelling of the veins above and behind the testicles (varicocele).
Croatian: • Oticanje vena iznad i iza testisa (varikokela).
English: • For further injections with the prepared solution of GONAL-f, repeat steps 4. to 7.
Croatian: • Za daljnje injekcije pripremljene otopine lijeka GONAL-f, ponovite korake od 4. do 7.
English: If you notice any of the above-listed side effects you should immediately contact your doctor who might ask you to stop using GONAL-f.
Croatian: Ako primijetite bilo koju gore navedenu nuspojavu, odmah se obratite svojem liječniku koji će od Vas možda zatražiti da prestanete uzimati GONAL-f.
English: Other medicines and GONAL-f
Croatian: Drugi lijekovi i GONAL-f
English: Table: Results of study GF 8407 (randomised parallel group study comparing efficacy and safety of GONAL-f with urinary FSH in assisted reproduction technologies)
Croatian: Tablica: Rezultati studije GF 8407 (randomizirana studija s usporednim skupinama koja je uspoređivala djelotvornost i sigurnost lijeka GONAL-f s urinarnim FSH pri medicinski potpomognutoj oplodnji)
English: A commonly used regimen commences at 75-150 IU FSH daily and is increased preferably by 37.5 or 75 IU at 7 or preferably 14 day intervals if necessary, to obtain an adequate, but not excessive, response.
Croatian: Uobičajeni režim započinje sa 75-150 IU FSH na dan te se povećava za 37,5 ili 75 IU u intervalima od 7 ili još bolje 14 dana, po potrebi, kako bi se postigao odgovarajući, ali ne i prejaki odgovor.
English: In women with recent or ongoing thromboembolic disease or women with generally recognised risk factors for thromboembolic events, such as personal or family history, treatment with gonadotropins may further increase the risk for aggravation or occurrence of such events.
Croatian: U žena s nedavnom ili trenutno prisutnom tromboembolijskom bolešću ili u žena s opće prepoznatim rizicima za tromboembolijske događaje, kao što su osobna ili obiteljska anamneza, liječenje gonadotropinima može još više povećati rizik od pogoršanja ili pojave takvih događaja.
English: If you had in the past or recently blood clots in the leg or in the lung, or a heart attack or stroke, or if those happened in your family, then you might have a higher risk that these problems occur or become worse with GONAL-f treatment.
Croatian: Ako ste nedavno ili u prošlosti imali krvne ugruške u nogama ili plućima, ili srčani ili moždani udar, ili ako je u Vašoj obitelji bilo takvih bolesti, postoji povećan rizik da se ovi problemi pojave ili pogoršaju tijekom liječenja lijekom GONAL-f.
English: Number of oocytes retrieved
Croatian: Broj dobivenih oocita
English: If you do not see a tiny drop(s) at or near the needle tip the first time you use a new pen, you must perform the steps on the next page.
Croatian: Ako ne ugledate kapljicu (kapljice) na vrhu ili blizu vrha igle kad prvi put koristite novu brizgalicu, morate provesti korake opisane na sljedećoj stranici.
English: This instructionsfor use was last revised in:
Croatian: Uputa je zadnji puta revidirana u:
English: Warning: Please read these instructions for use before using your GONAL-f pre-filled pen.
Croatian: Upozorenje: Molimo Vas da pročitate ove upute za uporabu prije nego što počnete koristiti napunjenu brizgalicu lijeka GONAL-f.
English: It is not yet established whether or not treatment with gonadotropins increases the risk of these tumours in infertile women.
Croatian: Još nije utvrđeno povećava li terapija gonadotropinima osnovni rizik za razvoj ovih tumora u neplodnih žena ili ne.
English: In women, the most important effect resulting from parenteral administration of FSH is the development of mature Graafian follicles.
Croatian: U žena, najvažniji učinak koji proizlazi iz parenteralne primjene FSH-a je razvoj zrelih Graafovih folikula.
English: Following intravenous administration, follitropin alfa is distributed to the extracellular fluid space with an initial half-life of around 2 hours and eliminated from the body with a terminal half-life of about one day.
Croatian: Nakon intravenske primjene, folitropin alfa se raspoređuje u prostor izvanstanične tekućine s početnim poluvijekom od oko 2 sata i eliminira iz tijela s terminalnim poluvijekom od otprilike 1 dana.
English: • Store the pen in its original packaging in a safe place.
Croatian: • Čuvajte brizgalicu u originalnom pakiranju na sigurnom mjestu.
English: To minimise the risk of multiple pregnancy, careful monitoring of ovarian response is recommended.
Croatian: Kako bi se smanjio rizik od višeplodnih trudnoća, preporučuje se pažljivo praćenje odgovora jajnika.
English: Switzerland or
Croatian: Švicarska ili
English: Proceed to Section 5: Setting the dose prescribed by your doctor.
Croatian: Nastavite do dijela 5: Podešavanje doze koju Vam je propisao liječnik
English: Therefore, it is considered appropriate to give a lower total dose of GONAL-f than generally used for urinary FSH, not only in order to optimise follicular development but also to minimise the risk of unwanted ovarian hyperstimulation.
Croatian: Stoga se smatra prikladnim davati manje ukupne doze lijeka GONAL-f od doza općenito primjenjivanih za urinarni FSH, ne samo radi optimiziranja razvoja folikula, nego također radi umanjivanja rizika od neželjene hiperstimulacije jajnika.
English: GONAL-f should not be used when an effective response cannot be obtained.
Croatian: GONAL-f se ne smije koristiti kada se ne može postići učinkovita reakcija.
English: GONAL-f must not be used when an effective response cannot be obtained, such as:
Croatian: GONAL-f se ne smije koristiti kada se ne može postići učinkovita reakcija, primjerice, u sljedećim slučajevima:
English: Your doctor will have told you how many IUs to inject each day.
Croatian: Vaš liječnik će Vam reći koliko IU trebate ubrizgati svaki dan.
English: • If you have irregular periods, start using GONAL-f within the first 7 days of your menstrual cycle.
Croatian: • Ako imate neredovite menstruacije, počinite primjenjivati GONAL-f unutar prvih 7 dana menstruacijskog ciklusa.
English: • An empty syringe for injection (see illustration below)
Croatian: • Praznu štrcaljku za injekciju (vidjeti sliku u nastavku)
English: • After a minimum of 5 seconds, pull the needle out of the skin while keeping the dose setting knob pressed down (3).
Croatian: • Nakon najmanje 5 sekundi, izvucite iglu iz kože i dalje držeći pritisnut gumb za podešavanje (3).
English: Women with anovulation resulting from severe LH and FSH deficiency.
Croatian: Žene s anovulacijom kao posljedicom teškog nedostatka LH i FSH.
English: • Breast development, acne or weight gain.
Croatian: • Razvoj dojki, akne ili dobivanje na težini.
English: • Serious blood clotting complications (thromboembolic events) sometimes independent of OHSS may be found very rarely (may affect up to 1 in 10,000 people).
Croatian: • Ozbiljne komplikacije zbog zgrušavanja krvi (tromboembolijski događaji) ponekad neovisno o OHSS vrlo se rijetko bilježe (mogu se javiti u manje od 1 na 10 000 osoba).
English: • if you are allergic to Follicle Stimulating Hormone or any of the other ingredients of this medicine listed in section 6.
Croatian: • ako ste alergični na folikul stimulirajući hormon ili neki drugi sastojak ovog lijeka naveden u dijelu 6.
English: Patients must be provided with the correct number of pens for their treatment course and educated to use the proper injection techniques.
Croatian: Pacijenti moraju dobiti odgovarajući broj brizgalica za svoj ciklus liječenja te ih je potrebno educirati o pravilnim tehnikama injiciranja.
English: Never store the pen with the needle attached.
Croatian: Nikad nemojte pohraniti brizgalicu s pričvršćenom iglom.
English: The maximal daily dose is usually not higher than 225 IU FSH.
Croatian: Najveća dnevna doza obično nije veća od 225 IU FSH.