FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with porphyria or a family history of porphyria should be closely monitored during treatment with Pergoveris.
Croatian: Pacijentice koje boluju od porfirije ili imaju porfiriju u obitelji treba pažljivo pratiti za vrijeme liječenja lijekom Pergoveris.
English: Safety, efficacy, and pharmacokinetics of this medicinal product in patients with renal or hepatic impairment have not been established.
Croatian: Sigurnost, djelotvornost i farmakokinetika ovog lijeka u pacijenata s oštećenjem bubrega ili jetre nije ustanovljena.
English: Via delle Magnolie 15 (Zona Industriale) I-70026 Modugno (Bari) Italy
Croatian: Via delle Magnolie 15 (Zona Industriale) I-70026 Modugno (Bari) Italija
English: Elimination Total clearance is around 2 L/h, and less than 5% of the dose is excreted in the urine.
Croatian: Eliminacija Ukupni klirens je oko 2 l/h, a manje od 5% doze izlučuje se u urin.
English: It should be noted however, that pregnancy itself as well as OHSS also carries an increased risk of thromboembolic events.
Croatian: No, treba navesti da i sama trudnoća nosi povećan rizik razvoja tromboembolije.
English: • If you administer Pergoveris to yourself, please carefully read and follow section “Instructions for Use”.
Croatian: • Ako sami sebi dajete Pergoveris, pažljivo pročitajte i pridržavajte se dijela „Upute za primjenu“.
English: Detailed information on this medicine is available on the European Medicine Agency web site: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 June 2007
Croatian: Datum prvog odobrenja: 25. lipnja 2007.
English: What Pergoveris is and what it is used for What you need to know before you use Pergoveris How to use Pergoveris
Croatian: Što je Pergoveris i za što se koristi Što morate znati prije nego počnete primjenjivati Pergoveris Kako primjenjivati Pergoveris Moguće nuspojave
English: Warning: Medicine should not be disposed of via wastewater or household waste.
Croatian: Upozorenje: Lijek se ne smije bacati u otpadne vode ili kućni otpad.
English: If an excessive response is obtained, treatment should be stopped and hCG withheld.
Croatian: U slučaju pretjerane reakcije, potrebno je obustaviti terapiju i izostaviti hCG.
English: If you get lower abdominal pain, gain any weight rapidly, feel sick or are vomiting or if you have difficulty in breathing, talk to your doctor straight away.
Croatian: Ako osjetite bol u donjem dijelu trbuha, brzo dobivate na težini, osjećate mučninu ili povraćate, ili otežano dišete, odmah se obratite svojem liječniku.
English: • When the pen is empty, ask your pharmacist how to dispose of it.
Croatian: • Kad se brizgalica isprazni, upitajte ljekarnika kako da je bacite.
English: • Carefully remove and discard the green inner shield.
Croatian: • Pažljivo uklonite i bacite zeleni unutarnji štitnik igle.
English: • if you have a condition that would make a normal pregnancy impossible, such as an early menopause, malformed sex organs or benign tumours of the womb.
Croatian: • ako bolujete od stanja zbog kojih ne možete imati normalnu trudnoću, kao što su preuranjena menopauza, deformacije spolnih organa ili benigni tumori maternice.
English: 6.6 Special precautions for disposal and other handling For immediate and single use following first opening and reconstitution.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Za neposrednu i jednokratnu primjenu nakon prvog otvaranja i rekonstitucije.
English: • After injection, read the number shown in the Dose Feedback Window.
Croatian: • Nakon injekcije, pročitajte broj prikazan u prozorčiću za prikaz doze.
English: • one sharps container for safe disposal of glass and needles
Croatian: • jedna posuda za sigurno uklanjanje stakla i igala
English: Follitropin alfa
Croatian: Folitropin alfa
English: You can turn the dose knob backwards if you turn it past 25 (Fig. 5).
Croatian: Možete zakrenuti kotačić za namještanje doze unatrag ako ga zakrenete na više od 25 (Sl. 5).
English: Your doctor will ensure, careful monitoring of the ovarian response, based on ultrasound and blood tests (oestradiol measurements) before and during the course of treatment.
Croatian: Vaš će liječnik pozorno pratiti odgovor jajnika, na temelju pretraga ultrazvukom i pretraga krvi (mjerenja razine estradiola) prije i tijekom liječenja.
English: Warning: Check that the Dose Feedback Window displays your complete prescribed dose before you move on to the next step.
Croatian: Upozorenje: Provjerite je li u prozorčiću za prikaz doze prikazana cijela propisana doza prije nego što krenete na sljedeći korak.
English: Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and oestrogen response.
Croatian: Terapiju treba prilagoditi individualnom odgovoru pacijentice, koji se ocjenjuje mjerenjem veličine folikula ultrazvukom i estrogenog odgovora.
English: If severe OHSS occurs, gonadotropin treatment should be stopped if still ongoing.
Croatian: Ako dođe do teškog OHSS-a, liječenje gonadotropinom, ukoliko je još uvijek u tijeku, treba prekinuti.
English: When you get the desired response, you will be given a single injection of human chorionic gonadotropin (hCG) 24 to 48 hours after your last Pergoveris injection.
Croatian: Kada je postignut željeni odgovor, dat će Vam se jedna injekcija humanog korionskog gonadotropina (hCG) 24-48 sati nakon zadnje injekcije lijeka Pergoveris.
English: The medicine must be administered immediately after reconstitution.
Croatian: Lijek se mora primijeniti odmah nakon pripreme.
English: • The pen comes in 3 different multi-dose presentations:
Croatian: • Brizgalica se isporučuje u 3 različita višedozna oblika:
English: Treatment Day Number
Croatian: Redni broj dana liječenja
English: DO NOT discard it.
Croatian: NEMOJTE ga baciti.
English: An example of a treatment diary using a pen:
Croatian: Primjer dnevnika liječenja pri uporabi brizgalice:
English: • Serious blood clotting problems (thromboembolic events) usually with severe OHSS are found very rarely.
Croatian: • Teški problemi sa zgrušavanjem krvi (tromboembolije), obično s teškim OHSS-om, vrlo su rijetki.
English: After the injection, dispose of the used needle safely.
Croatian: Nakon injekcije, uporabljenu iglu bacite na siguran način.
English: Other in-use storage times and conditions are the responsibility of the user.
Croatian: Drugačije trajanje čuvanja i drugačiji uvjeti čuvanja lijeka u primjeni odgovornost su korisnika.
English: Data on a limited number of exposed pregnancies indicate no adverse reactions of follitropin alfa and lutropin alfa on pregnancy, embryonal or foetal development, parturition or postnatal development following controlled ovarian stimulation.
Croatian: Podaci dobiveni na ograničenom broju izloženih trudnica ne upućuju na nuspojave folitropina alfa i lutropina alfa na trudnoću, embrionalni ili fetalni razvoj, parturiciju ili postnatalni razvoj nakon kontrolirane stimulacije jajnika.
English: Verify once more that the Dose Feedback Window displays the correct dose.
Croatian: 7.3. Provjerite još jedanput da prozorčić za prikaz doze prikazuje ispravnu dozu.
English: Warning: Refer to the Package leaflet for more information on the recommended dose regimen and always follow the dose recommended by your doctor.
Croatian: Upozorenje: Dodatne informacije o preporučenom režimu doziranja potražite u uputi o lijeku i uvijek se pridržavajte doze koju Vam je preporučio liječnik.
English: • Slowly press the dose knob down as far as it will go and hold it to complete the full injection.
Croatian: • Polako pritišćite kotačić za namještanje doze onoliko koliko ide i tako ga držite kako biste dovršili davanje cijele injekcije.
English: There is no relevant indication for the use of Pergoveris in the elderly population.
Croatian: Nema relevantne indikacije za primjenu lijeka Pergoveris u starijoj populaciji.
English: • if you have a brain tumour (in your hypothalamus or pituitary gland)
Croatian: • ako imate tumor mozga (hipotalamusa ili hipofize)
English: This side effect is uncommon (may affect up to 1 in 100 people).
Croatian: Ova nuspojava nije česta (može se pojaviti kod do 1 na 100 osoba).
English: Gonadotrophin therapy requires a certain time commitment by physicians and supportive health care professionals, as well as the availability of appropriate monitoring facilities.
Croatian: Terapija gonadotropinom zahtijeva određenu vremensku obvezu liječnika i ostalih zdravstvenih djelatnika te postojanje odgovarajuće opreme i mogućnosti praćenja postupka liječenja neplodnosti.
English: • Check that the peel-off seal on the outer needle cap is not damaged or loose (Fig.3).
Croatian: • Provjerite da odvojiva zaštitna folija na vanjskom zatvaraču igle nije oštećena ili odvojena (Sl. 3).
English: Verify the expiration date on the pen label (Fig. 2).
Croatian: Provjerite datum isteka roka valjanosti na naljepnici brizgalice (Sl. 2).
English: Talk to your doctor before you start your treatment.If you or any member of your family have porphyria (an inability to breakdown porphyrins that may be passed on from parents to children).
Croatian: Obavijestite liječnika ako bolujete od porfirije ili ako je netko u obitelji bolovao od te bolesti (nesposobnosti razgradnje porfirina koja se može prenositi s roditelja na djecu).
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, thrombophilia or severe obesity (body mass index > 30 kg/m2), treatment with gonadotrophins may further increase the risk.
Croatian: U žena koje su nedavno bolovale od tromboembolije ili od nje trenutačno boluju ili u žena s općepoznatim čimbenicima rizika za tromboembolijske događaje kao što su osobna i obiteljska anamneza, trombofilija ili teška pretilost (indeks tjelesne težine > 30 kg/m2) terapija gonadotropinima može dodatno povećati rizik.
English: Self-administration should only be performed by patients who are well motivated, adequately trained and with access to expert advice.
Croatian: Pacijentice si samostalno mogu davati injekcije samo ako su dovoljno motivirane, odgovarajuće podučene i one koje se u svako doba mogu posavjetovati sa stručnjakom.
English: This syndrome occurs with higher incidence in patients with polycystic ovarian disease.
Croatian: Incidencija ovog sindroma je veća kod pacijentica s policističnom bolešću jajnika.
English: • Continue by pushing the capped needle against a firm surface until you hear a “click”.
Croatian: • Zatim iglu pokrivenu zatvaračem pritisnite o čvrstu podlogu sve dok ne začujete ”klik”.
English: Do not use Pergoveris if you notice any visible signs of deterioration, if the liquid contains particles or is not clear.
Croatian: Pergoveris se ne smije upotrijebiti ako primijetite bilo kakve vidljive znakove kvarenja, ako tekućina sadrži čestice ili nije bistra.
English: Chemical and physical in-use stability has been demonstrated for 28 days at 25°C.
Croatian: Dokazano je da je lijek u primjeni kemijski i fizikalno stabilan tijekom 28 dana na temperaturi od 25 °C.
English: The pH of the solution is 6.5 - 7.5, its osmolality is 250 - 400 mOsm/kg.
Croatian: PH otopine je 6,5-7,5, a njezina osmolalnost je 250-400 mOsm/kg.
English: Pergoveris is indicated for use in infertility (see section 4.1).
Croatian: Pergoveris je indiciran za primjenu kod neplodnosti (vidjeti dio 4.1).
English: Pregnancy and breast-feeding Do not use Pergoveris if you are pregnant or breast-feeding.
Croatian: Trudnoća i dojenje Nemojte primjenjivati Pergoveris ako ste trudni ili dojite.
English: Check for particles as before, and do not use if the solution is not clear.
Croatian: Kao i prije, provjerite ima li čestica i nemojte primjenjivati ako otopina nije bistra.
English: Elimination Total clearance is 0.6 L/h and one-eighth of the follitropin alfa dose is excreted in the urine.
Croatian: Eliminacija Ukupni klirens je 0,6 l/h i jedna osmina doze folitropina alfa izlučuje se u urinu.
English: Independent risk factors for developing OHSS include young age, lean body mass, polycystic ovarian syndrome, higher doses of exogenous gonadotrophins, high absolute or rapidly rising serum oestradiol level (> 900 pg/mL or > 3,300 pmol/L in anovulation), previous episodes of OHSS and large number of developing ovarian follicles (3 follicles of ≥ 14 mm in diameter in anovulation).
Croatian: Neovisni faktori rizika za razvoj OHSS-a uključuju mladu dob, tjelesnu masu bez masnog tkiva, sindrom policističnih jajnika, veće doze egzogenih gonadotropina, visoku apsolutnu ili brzo rastuću razinu estradiola u serumu (> 900 pg/ml ili > 3300 pmol/l tijekom anovulacije), prethodne epizode OHSS-a i velik broj folikula jajnika u razvoju (3 folikula promjera ≥ 14 mm tijekom anovulacije).
English: Pergoveris is indicated for the stimulation of follicular development in adult women with severe LH and FSH deficiency.
Croatian: Pergoveris je indiciran za stimuliranje razvoja folikula u odraslih žena s teškim nedostatkom LH i FSH.
English: • It is important that your hands and the items you use be as clean as possible
Croatian: • Važno je da Vaše ruke i predmeti koje koristite budu što čišći • Prikladno mjesto je čisti stol ili kuhinjske površine
English: This becomes more likely if the medicine that is used for final follicular maturation (containing human chorionic gonadotrophin, hCG) is administered (see in section 3. under “How much to use” for details).
Croatian: To je vjerojatnije kada se daje lijek za poticanje konačnog sazrijevanja folikula (koji sadrži humani koriogonadotropin, hCG) (pogledajte detalje u dijelu 3 u „Koliko lijeka trebate primijeniti“).
English: * produced in genetically engineered Chinese hamster ovary (CHO) cells.
Croatian: * proizveden genetičkim inženjerstvom na stanicama jajnika kineskog hrčka (CHO).
English: 6.6 Special precautions for disposal and other handling Only clear solution without particles should be used.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Smije se primijeniti samo bistra otopina bez čestica.
English: Following intravenous administration, lutropin alfa is rapidly distributed with an initial half-life of approximately one hour and eliminated from the body with a terminal half-life of about 10-12 hours.
Croatian: Nakon intravenske primjene, lutropin alfa se brzo distribuira, uz početni poluvijek od približno 1 sata i eliminira se iz tijela s terminalnim poluvijekom od oko 10-12 sati.
English: There may be a degree of interpatient variability in response to FSH/LH administration, with a poor response to FSH/LH in some patients.
Croatian: Među pacijenticama mogu postojati razlike u odgovoru na primjenu FSH/LH, a neke mogu imati i slabi odgovor na FSH/LH.
English: • The numbers displayed in the Dose Feedback Window help you to:
Croatian: • Brojevi prikazani u prozorčiću za prikaz doze služe Vam da:
English: In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and appropriate specific treatment should be given.
Croatian: Posebno treba provjeriti boluju li pacijentice od hipotiroidizma, adrenokortikalne insuficijencije, hiperprolaktinemije te je tada potrebno primijeniti odgovarajuću terapiju.
English: Following subcutaneous administration, the absolute bioavailability is approximately 60%; the terminal half-life is slightly prolonged.
Croatian: Nakon supkutane primjene, apsolutna bioraspoloživost iznosi oko 60%, a terminalni poluvijek neznatno je produžen.
English: When using Pergoveris, you have a higher risk of being pregnant with more than one child at the same time (“multiple pregnancy”, mostly twins), than if you conceived naturally.
Croatian: Tijekom primjene lijeka Pergoveris postoji veći rizik od višeplodne trudnoće („višestruka trudnoća“, uglavnom blizanačka) nego kod prirodnog začeća.
English: In clinical trials the efficacy of the combination of follitropin alfa and lutropin alfa has been demonstrated in women with hypogonadotropic hypogonadism.
Croatian: U kliničkim ispitivanjima djelotvornost kombinacije folitropina alfa i lutropina alfa je dokazana kod žena s hipogonadotropnim hipogonadizmom.
English: Your doctor or nurse will have already advised you where to inject (e.g. tummy, front of thigh).
Croatian: Vaš liječnik ili medicinska sestra već su Vam savjetovali gdje trebate dati injekciju (npr. trbuh, prednji dio bedra).
English: A comparative clinical study between the freeze-dried and the liquid formulation showed bioequivalence between the two formulations.
Croatian: Klinička ispitivanja koja su uspoređivala liofiliziranu i tekuću formulaciju pokazala su da su te dvije formulacije bioekvivalentne.
English: • 1 vial containing Pergoveris powder • 1 vial containing water for injections (solvent)
Croatian: • 1 bočicu koja sadrži prašak Pergoveris • 1 bočicu koja sadrži vodu za injekcije (otapalo)
English: • LH stimulates the release of the eggs.
Croatian: • LH stimulira otpuštanje jajnih stanica.
English: If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7-14 day intervals and preferably by 37.5-75 IU increments using a licensed follitropin alfa preparation.
Croatian: Ako se pokaže potreba za povećanom dozom FSH, prilagodba doze bi se trebala izvršiti nakon intervala od 7 do 14 dana i to po mogućnosti uvećanjem za 37,5-75 IU uz korištenje registriranog pripravka folitropina alfa.
English: NOTE: Using your treatment diary to record your daily injection(s) allows you to verify that you received the full prescribed dose every day.
Croatian: Korištenje dnevnika liječenja za svakodnevno bilježenje primjene injekcija omogućuje Vam da provjerite jeste li svaki dan primili punu dozu koja Vam je propisana.
English: Caution: Never store the pen with the needle still attached.
Croatian: Oprez: Nikada nemojte čuvati brizgalicu s iglom koja je još spojena.
English: Warning: Do not recap the needle with the green inner shield, as it can lead to needle stick.
Croatian: Upozorenje: Nemojte vraćati zeleni unutarnji štitnik na iglu, jer to može dovesti do uboda na iglu.
English: There is no indication for the use of Pergoveris during pregnancy.
Croatian: Ne postoje indikacije za primjenu lijeka Pergoveris tijekom trudnoće.
English: If less than one vial daily is used, the follicular response may be unsatisfactory because the amount of lutropin alfa may be insufficient (see section 5.1).
Croatian: Ako se koristi manje od 1 bočice dnevno, odgovor folikula može biti nezadovoljavajuć zbog nedostatne količine lutropina alfa (vidjeti dio 5.1).
English: Talk to your doctor before using Pergoveris if you or a member of your family have ever had blood clots in the leg or in the lung, or a heart attack or stroke.
Croatian: Problemi sa zgrušavanjem krvi (tromboembolijski događaji) Obratite se svojem liječniku prije primjene lijeka Pergoveris ako ste Vi ili član Vaše obitelji imali krvne ugruške u nogama ili plućima, srčani ili moždani udar.
English: Manufacturer Merck Serono S.p.A, Via delle Magnolie 15 (Zona industriale), I-70026 Modugno (Bari), Italy
Croatian: Proizvođač Merck Serono S.p.A, Via delle Magnolie 15 (Zona industriale), I-70026 Modugno (Bari), Italija
English: For instructions on the use of this medicinal product, see the package leaflet, section 'Instructions for use'.
Croatian: Za upute o primjeni ovog lijeka vidjeti dio „Upute za primjenu” u uputi o lijeku.
English: Driving and using machines It is not expected that this medicine will affect your ability to drive or use machines.
Croatian: Ne očekuje se da će ovaj lijek utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
English: There have been isolated reports of non-serious allergic reactions to Pergoveris.
Croatian: Postoje podaci o izoliranim slučajevima blagih alergijskih reakcija na Pergoveris.
English: Read the leaflet for the shelf life of the reconstituted medicine.
Croatian: Pročitajte Uputu o lijeku za rok valjanosti rekonstituiranog lijeka.
English: a. Dial your prescribed dose.
Croatian: a. odaberete propisanu dozu.
English: • The OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty in breathing and/or possible fluid accumulation in your stomach or chest.
Croatian: • OHSS može postati težak uz jasno uvećane jajnike, smanjeno stvaranje mokraće, povećanje tjelesne težine, poteškoće pri disanju i/ili s mogućim nakupljanjem tekućine u trbuhu ili prsnom košu.
English: Clinical studies with Pergoveris were conducted with a freeze-dried formulation.
Croatian: Klinička ispitivanja lijeka Pergoveris provedena su s liofiliziranom formulacijom.
English: • If needed, turn the dose setting knob backward to correct the dose.
Croatian: • Po potrebi, zakrenite kotačić za namještanje doze unatrag da biste ispravili dozu.
English: c. Read the dose remaining to be injected with a second pen.
Croatian: c. pročitate preostalu dozu koju treba ubrizgati iz druge brizgalice.
English: • Get a new needle - only use the "single-use" needles supplied.
Croatian: • Uzmite novu iglu - koristite samo priložene igle za jednokratnu primjenu.
English: • The Dose Feedback Window will indicate the missing amount you need to inject using a new pen.
Croatian: • U prozorčiću za prikaz doze pokazat će se količina koja nedostaje i koju trebate ubrizgati pomoću nove brizgalice.
English: Do not use Pergoveris with other medicines in the same injection.
Croatian: Pergoveris se ne smije primjenjivati s drugim lijekovima u istoj injekciji.
English: • Pergoveris is intended to be given by injection just under the skin (subcutaneously).
Croatian: • Pergoveris je namijenjen za primjenu injekcijom pod kožu (potkožno).
English: What Pergoveris is and what it is used for
Croatian: Što je Pergoveris i za što se koristi
English: Pergoveris should be given as a course of daily injections.
Croatian: Pergoveris se treba primjenjivati u seriji dnevnih injekcija.
English: To minimise skin irritation, select a different injection site each day.
Croatian: Kako biste ublažili nadraživanje kože, svakog dana odaberite drugo mjesto injiciranja.
English: Other medicines and Pergoveris Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako primjenjujete, nedavno ste primijenili ili biste mogli primijeniti bilo koje druge lijekove.
English: Breast pain, pelvic pain, mild or moderate OHSS (including associated symptomatology)
Croatian: Bolovi u dojkama, bolovi u zdjelici, blagi do umjereni OHSS (uključujući i povezanu simptomatologiju)
English: Treatment with Pergoveris should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Croatian: Terapija lijekom Pergoveris treba započeti pod nadzorom liječnika s iskustvom u liječenju neplodnosti.
English: How to use your Pergoveris pre-filled pen treatment diary A treatment diary is included on the last page.
Croatian: Kako koristiti svoj dnevnik liječenja Pergoveris napunjenom brizgalicom Dnevnik liječenja nalazi se na zadnjoj stranici.
English: The effects of an overdose of Pergoveris are unknown.
Croatian: Učinci predoziranja lijekom Pergoveris nisu poznati.
English: THEN
Croatian: ONDA
English: Getting familiar with the parts of your Pergoveris pre-filled pen Getting your Pergoveris pre-filled pen ready for injection Setting the dose prescribed by your doctor Injecting the dose
Croatian: Upoznavanje s dijelovima Vaše Pergoveris napunjene brizgalice Priprema Vaše Pergoveris napunjene brizgalice za injekciju Namještanje doze koju Vam je propisao liječnik Ubrizgavanje doze
English: • Pick up your syringe and slowly inject the contents of the syringe into the vial of powder.
Croatian: • Podignite štrcaljku i polako ubrizgajte sadržaj štrcaljke u bočicu s praškom.
English: Caution: Do not release the dose knob until you remove the needle from the skin.
Croatian: Oprez: Nemojte otpuštati kotačić za namještanje doze prije nego što izvučete iglu iz kože.