FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, if signs of ovarian hyperstimulation occur, it is recommended that hCG be withheld and the patient be advised to refrain from coitus or use barrier contraceptive methods for at least 4 days.
Croatian: Stoga, u slučaju pojave znakova hiperstimulacije jajnika preporučuje se obustava terapije hCG-om, a pacijentice treba savjetovati da se suzdrže od spolnog odnosa ili da koriste barijernu metodu kontracepcije tijekom najmanje 4 dana.
English: Safety and effectiveness of Luveris in elderly patients have not been established.
Croatian: Sigurnost i djelotvornost lijeka Luveris nisu ustanovljene u starijih pacijentica.
English: • Dispose of all used items: Once you have finished your injection, immediately discard all needles and empty glass containers in the sharps container provided.
Croatian: • Bacite sve korištene predmete: Nakon dovršetka injiciranja odmah bacite sve igle i prazne staklene spremnike u spremnik za oštre predmete.
English: • The active substance is lutropin alfa.
Croatian: • Djelatna tvar je lutropin alfa.
English: Multiple pregnancy, especially high order, carry an increased risk of adverse maternal and perinatal outcomes.
Croatian: Višeplodna trudnoća, pogotovo ona s velikim brojem plodova, donosi povećani rizik neželjenih majčinih i perinatalnih ishoda.
English: If an excessive response is obtained, treatment should be stopped and hCG withheld.
Croatian: U slučaju pretjeranog odgovora, potrebno je obustaviti liječenje i ne primijeniti hCG.
English: The pharmacokinetics of lutropin alfa have been studied in pituitary desensitised female volunteers from 75 IU up to 40,000 IU.
Croatian: Farmakokinetika lutropina alfa proučavana je u ženskih dobrovoljaca s desenzitiziranom hipofizom u jedinicama od 75 do 40 000 IU.
English: You may also mix Luveris and follitropin alfa as an alternative to injecting each product separately.
Croatian: Možete također miješati Luveris i folitropin alfa kao alternativu injiciranju svakog lijeka zasebno.
English: In this case Luveris should be reconstituted first and then used to reconstitute the follitropin alfa powder.
Croatian: U tom slučaju Luveris treba rekonstruirati prvi i potom ga upotrijebiti za rekonstituciju praška folitropina alfa.
English: If an excessive response is obtained, treatment should be stopped and hCG withheld (see section ‘Possible Side Effects').
Croatian: U slučaju prekomjernog odgovora, liječenje treba obustaviti te ne primjenjivati hCG (pogledajte dio „Moguće nuspojave“).
English: Reproductive system neoplasms
Croatian: Neoplazme reproduktivnog sustava
English: Luteal phase support may be considered since lack of substances with luteotrophic activity (LH/hCG) after ovulation may lead to premature failure of the corpus luteum.
Croatian: Može se razmotriti i potpora luteinskoj fazi, budući da manjak tvari s luteotropnim djelovanjem (LH/hCG) nakon ovulacije može dovesti do preranog propadanja žutog tijela.
English: Luveris is recommended for the treatment of adult women who have been shown to produce very low levels of some of the hormones involved in the natural reproductive cycle.
Croatian: Luveris se preporučuje za liječenje odraslih žena kod kojih su nađene vrlo niske razine nekih hormona uključenih u prirodni ciklus reprodukcije.
English: Luveris has no or negligible influence on the ability to drive and use machines.
Croatian: Luveris ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Nervous system disorders Common: Headache
Croatian: Poremećaji živčanog sustava Često: Glavobolja.
English: The solvent is packaged either in 2 or 3 ml neutral colourless glass (type I) vials with a Teflon-coated rubber stopper or in 2 ml neutral colourless glass (type I) ampoules.
Croatian: Otapalo se nalazi u bočicama od 2 ili 3 ml od bezbojnog neutralnog stakla (tip I) s gumenim čepom obloženim teflonom ili u ampulama volumena 2 ml od neutralnog bezbojnog stakla (tip I).
English: INFORMATION IN BRAILLE luveris 75 iu
Croatian: 16. PODACI NA BRAILLEOVOM PISMU luveris 75 iu
English: Driving and using machines Luveris has no or negligible influence on the ability to drive and use machines.
Croatian: Upravljanje vozilima i strojevima Luveris ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: In order to avoid the injection of large volumes, one vial of Luveris can be reconstituted together with one or two ampoule(s)/vial(s) of follitropin alfa, 37.5 IU, 75 IU or 150 IU, in 1 ml of solvent.
Croatian: Kako bi se izbjeglo injiciranje velikih volumena, jedna bočica Luverisa može se rekonstituirati zajedno s jednom ili dvije ampule/bočice folitropina alfa jačine 37,5 IU, 75 IU ili 150 IU, u 1 ml otapala.
English: The powder is packaged in 3 ml neutral colourless glass (type I) vials.
Croatian: Prašak je pakiran u bočice volumena 3 ml od bezbojnog neutralnog stakla (tip I).
English: Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events, such as pulmonary embolism, ischaemic stroke or myocardial infarction.
Croatian: Vrlo rijetko, teški OHSS može biti popraćen komplikacijama kao što su torzija jajnika ili tromboembolijskim događajima kao što su plućna embolija, ishemijski moždani udar ili infarkt miokarda.
English: Independent risk factors for developing OHSS include young age, lean body mass, polycystic ovarian syndrome, higher doses of exogenous gonadotropins, high absolute or rapidly rising serum estradiol levels and previous episodes of OHSS, large number of developing ovarian follicles and large number of oocytes retrieved in ART cycles.
Croatian: Nezavisni čimbenici za razvoj OHSS uključuju mlađu dob, bezmasnu tjelesnu masu, sindrom policističnih jajnika, više doze egzogenih gonadotropina, visoku apsolutnu ili brzorastuću serumsku razinu estradiola i prethodne epizode OHSS, veliki broj folikula jajnika u razvoju i veliki broj oocita dobivenih u ciklusima tehnika potpomognute oplodnje.
English: Lutropin alfa shows linear pharmacokinetics, as assessed by area under curve (AUC) which is directly proportional to the dose administered.
Croatian: Lutropin alfa pokazuje linearnu farmakokinetiku kako je to ocijenjeno površinom ispod krivulje (AUC) koja je izravno proporcionalna primijenjenoj dozi.
English: Clinical evaluation may reveal signs such as hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, pleural effusions, or acute pulmonary distress.
Croatian: Klinička procjena može otkriti znakove poput hipovolemije, hemokoncentracije, neravnoteže elektrolita, ascitesa, pleuralnog izljeva ili akutnog plućnog distresa.
English: What Luveris contains
Croatian: Što Luveris sadrži
English: The lutropin alfa pharmacokinetics following single and repeated administration of Luveris are comparable and the accumulation ratio of lutropin alfa is minimal.
Croatian: Farmakokinetika lutropina alfa nakon jedne i ponovljene primjene lijeka Luveris usporedive su, a stupanj akumulacije lutropina alfa je minimalan.
English: Luveris should be given as a course of daily injections simultaneously with FSH.
Croatian: Luveris treba davati kao dnevne injekcije simultano s FSH.
English: Lutropin alfa is produced in genetically engineered Chinese Hamster Ovary (CHO) cells.
Croatian: Lutropin alfa proizvodi se genetičkim inženjerstvom u stanicama jajnika kineskog hrčka (CHO).
English: In clinical trials, patients were defined by an endogenous serum LH level < 1.2 IU/l as measured in a central laboratory.
Croatian: U kliničkim ispitivanjima, pacijentice su bile definirane razinama endogenog LH u serumu < 1,2 IU/l kako je izmjereno u središnjem laboratoriju.
English: Once the powder has dissolved, draw the solution back into the syringe.
Croatian: Nakon što se prašak otopi, povucite otopinu ponovno u štrcaljku.
English: Name and address of the manufacturer responsible for batch release Merck Serono S.p.A.
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Merck Serono S.p.A.
English: Luveris is indicated for the stimulation of follicular development, in association with FSH (see section 4.1).
Croatian: Plodnost Luveris je indiciran za stimulaciju razvoja folikula u vezi s FSH (vidjeti dio 4.1).
English: The effects of an overdose of Luveris are unknown.
Croatian: Učinci predoziranja lijekom Luveris nisu poznati.
English: Do not shake.
Croatian: Nemojte potresati.
English: When an optimal response is obtained, a single injection of 250 microgramsof r-hCG or 5,000 IU to 10,000 IU hCG should be administered 24-48 hours after the last Luveris and FSH injections.
Croatian: Kad se postigne optimalan odgovor, treba se primijeniti jedna injekcija od 250 mikrograma rekombinantnog humanog korionskog gonadotropina (r-hCG) ili hCG od 5000 IU do 10 000 IU, 24-48 sati nakon posljednje injekcije Luverisa i FSH-a.
English: • ovarian enlargement or ovarian cyst unrelated to polycystic ovarian disease and of unknown origin
Croatian: • povećanje jajnika ili ciste jajnika koje nisu posljedica policistične bolesti jajnika i onih nepoznate etiologije
English: Solvent: Water for injection
Croatian: Otapalo: voda za injekcije
English: • tumours of the hypothalamus and pituitary gland
Croatian: • tumore hipotalamusa i hipofize
English: After dissolving the Luveris powder, draw the solution back into the syringe and re-inject it into the container with the follitropin alfa powder.
Croatian: Nakon otapanja praška Luveris, uvucite otopinu nazad u štrcaljku i ponovno injicirajte u spremnik s praškom folitropina alfa.
English: Talk to your doctor before using Luveris 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) Razgovarajte sa svojim liječnikom prije uporabe lijeka Luveris ili ako je član Vaše obitelji ikada imao krvne ugruške u nogama ili plućima, ili srčani ili moždani udar.
English: This 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 ovarian syndrome.
Croatian: To je možda povezano s ostalim faktorima rizika, kao što su OHSS, trudnoća, prethodna operacija u trbuhu, torzija jajnika u anamnezi, prethodna ili trenutačna cista na jajniku i sindrom policističnih jajnika.
English: Adherence to recommended Luveris and FSH dosage and regimen of administration can minimise the risk of ovarian hyperstimulation.
Croatian: Pridržavanje preporučenih doza Luverisa i FSH te režima primjene može smanjiti rizik od hiperstimulacije jajnika.
English: Paediatric population There is no relevant indication for the use of Luveris in the paediatric population.
Croatian: Pedijatrijska populacija Nema relevantne primjene lijekaLuveris u pedijatrijskoj populaciji.
English: The pharmacokinetic profile of lutropin alfa is similar to that of urinaryderived hLH.
Croatian: Farmakokinetički profil lutropina alfa sličan je hLH dobivenom iz mokraće.
English: In clinical trials, Luveris has been shown to increase the ovarian sensitivity to follitropin alfa.
Croatian: U kliničkim ispitivanjima dokazano je da Luveris povećava osjetljivost jajnika na folitropin alfa.
English: Alternatively, intrauterine insemination (IUI) may be performed.
Croatian: Drugi način može biti provođenje intrauterine inseminacije (IUI).
English: Packs of 1, 3 or 10 vials with the corresponding number of solvent vials or ampoules.
Croatian: Pakiranja od 1, 3 ili 10 bočica s odgovarajućim brojem bočica otapala ili ampula.
English: At doses of 10 IU/kg/day and greater, repeated administration of lutropin alfa to pregnant rats and rabbits caused impairment of reproductive function including resorption of foetuses and reduced body weight gain of the dams.
Croatian: Pri dozama od 10 IU/kg/dan i većim, opetovana primjena lutropina alfa kod gravidnih ženki štakora i kunića uzrokovala je oštećenje reproduktivne funkcije uključujući resorpciju fetusa i slabiji porast tjelesne težine mladunčadi.
English: A recommended regimen commences at 75 IU of lutropin alfa (ie. one vial of Luveris) daily with 75-150 IU FSH.
Croatian: Preporučeni protokol doziranja počinje sa 75 IU lutropina alfa (tj. jedna bočica lijeka Luveris) dnevno s 75-150 IU FSH.
English: The incidence of pregnancy loss by miscarriage or abortion is higher in patients undergoing stimulation of follicular growth for ovulation induction than following natural conception.
Croatian: Incidencija gubitka trudnoće pobačajem ili abortusom viša je u pacijentica koje se podvrgavaju stimulaciji rasta folikula kako bi se potaknula ovulacija, nego nakon prirodnog začeća.
English: • Change the needle for the fine-bore needle and remove any air bubbles: If you see air bubbles in the syringe, hold the syringe with the needle pointing upwards and gently flick the syringe until all the air collects at the top.
Croatian: • Promijenite iglu za iglu s finim otvorom i uklonite sve mjehuriće zraka: Ako vidite mjehuriće zraka u štrcaljki, držite štrcaljku s iglom uperenom prema gore i lagano je kucnite sve dok se zrak ne skupi na vrhu.
English: Gently flick the top section of the ampoule so that any fluid in the neck of the ampoule drops into the bottom chamber.
Croatian: Lagano tapkajte vrh ampule tako da tekućina u vratu ampule padne na donji dio.
English: It comprises marked ovarian enlargement, high serum sex steroids, and an increase in vascular permeability which can result in an accumulation of fluid in the peritoneal, pleural and, rarely, in the pericardial cavities.
Croatian: Uključuje izraženo povećanja jajnika, visoku razinu serumskih spolnih steroidnih hormona i povećanja vaskularne propusnosti, čija posljedica može biti nakupljanje tekućine u peritonealnoj, pleuralnoj te rijetko u perikardijalnoj šupljini.
English: • Local reactions at the injection site, such as pain, itching, bruising, swelling or irritation.
Croatian: • Lokalne reakcije na mjestu injiciranja kao što su bol, svrbež, modrice, crvenilo ili oticanje.
English: No teratogenic effect of Luveris has been observed in animal studies.
Croatian: U studijama na životinjama nisu opaženi teratogeni učinci Luverisa.
English: This increases your risk of developing Ovarian HyperStimulation Syndrome or OHSS.
Croatian: Time se povećava rizik razvijanja sindroma hiperstimulacije jajnika ili OHSS-a.
English: Common: Injection site reaction (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection)
Croatian: Često: Reakcija na mjestu davanja injekcije (npr. bol, eritem, hematom, oticanje i/ili iritacija na mjestu injekcije).
English: Torsion of the ovary and bleeding into the abdomen have not been reported with Luveris, however, there have been rare cases reported following treatment with human menopausal gonadotropin (hMG), a urine-derived medication also containing LH.
Croatian: Uvrtanje jajnika i krvarenje u trbuhu nisu prijavljene kod uporabe lijeka Luveris, no, prijavljeni su rijetki slučajevi nakon liječenje humanim menopauzalnim gonadotropinom (hMG), lijekom dobivenim iz mokraće koji također sadrži LH.
English: In rare instances, adnexal torsion (a complication of ovarian enlargement), and haemoperitoneum have been associated with human menopausal gonadotropin therapy.
Croatian: U rijetkim slučajevima torzija adneksa (komplikacija uvećanja jajnika) i hemoperitoneum bili su povezani s liječenjem humanim menopauzalnim gonadotropinom.
English: Ectopic pregnancy (embryo implanted outside the womb) may occur especially in women with a history of prior tubal disease.
Croatian: Izvanmaternična trudnoća (embrio usađen izvan maternice) može se pojaviti posebice u žena koje su imale bolesti jajovoda.
English: Luveris is a medicine containing lutropin alfa, a recombinant Luteinising Hormone (LH) which is essentially similar to the hormone found naturally in humans, but is made by means of biotechnology.
Croatian: Luveris je lijek koji sadrži lutropin alfa, rekombinantni luteinizirajući hormon (LH) koji je u osnovi sličan hormonu koji se prirodno nalazi kod ljudi, ali se dobiva biotehnološkim postupkom.
English: In patients undergoing induction of ovulation, the incidence of multiple pregnancy and births is increased compared with natural conception.
Croatian: Kod pacijentica koje se podvrgavaju indukcijama ovulacije, incidencija višeplodnih trudnoća i poroda povećana je u usporedbi s prirodnim začećem.
English: Talk to your doctor, pharmacist or nurse before using Luveris.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Luveris.
English: Luteinising Hormone (LH) binds on the ovarian theca (and granulosa) cells and testicular Leydig cells, to a receptor shared with human chorionic gonadotropin hormone (hCG).
Croatian: Luteinizirajući hormon (LH) veže se na teka (kao i na granuloza) stanice jajnika i na Leydigove stanice testisa, na receptor zajednički s humanim korionskim hormonom gonadotropinom (hCG).
English: • If you have ovarian enlargement or sacs of fluid within the ovaries (ovarian cyst) of unknown origin.
Croatian: • U slučaju uvećanja jajnika ili vrećica s tekućinom unutar jajnika (cista na jajnicima) nepoznatog podrijetla.
English: In the stimulation of follicular development in anovulatory women deficient in LH and FSH, the primary effect resulting from administration of lutropin alfa is an increase in estradiol secretion by the follicles, the growth of which is stimulated by FSH.
Croatian: U stimulaciji razvoja folikula kod anovulatornih žena s nedostatkom LH i FSH, primarni učinak primjene lutropina alfa je porast lučenja estradiola od strane folikula čiji rast je stimuliran s FSH.
English: Package leaflet: Information for the user Solvent in ampoules
Croatian: Uputa o lijeku: Informacija za korisnika Otapalo u bočicama
English: In patients undergoing Assisted Reproductive Technology (ART) procedures the risk of multiple pregnancy is related mainly to the number of embryos replaced, their quality and the patient age.
Croatian: U pacijentica koje su se podvrgnule tehnikama pomognute oplodnje rizik od višeplodnih trudnoća povezan je uglavnom s brojem transferiranih embrija, njihovom kvalitetom i dobi pacijentice.
English: Marketing Authorisation Holder Merck Europe B.V.
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet Merck Europe B.V.
English: • Luveris comes as a powder and solvent for solution for injection.
Croatian: • Luveris se isporučuje kao prašak i otapalo za otopinu za injekciju.
English: Common: Mild or moderate OHSS (including associated symptomatology), ovarian cyst, breast pain, pelvic pain
Croatian: Često: Blagi ili umjereni OHSS (uključujući povezanu simptomatologiju), cista na jajnicima, bol u dojkama, bol u zdjelici.
English: • gynaecological haemorrhages of unknown origin
Croatian: • ginekološko krvarenje nepoznate etiologije
English: • Lutropin alfa is recombinant human Luteinising Hormone (r-hLH), produced by recombinant DNA technology.
Croatian: • Lutropin alfa je rekombinantni humani luteinizirajući hormon (r-hLH) proizveden tehnologijom rekombinantne DNK.
English: It is followed by treatment with a single dose of human Chorionic Gonadotropin (hCG), which leads to the release of an egg from the follicle (ovulation).
Croatian: Nakon toga slijedi primjena jedne doze humanog korionskog gonadotropina (hCG) što dovodi do oslobađanja jajnih stanica iz folikula (ovulacija).
English: More user-friendly presentations are available for self administration by patients at home.
Croatian: Pakiranja lijeka koja su više prilagođena pacijentu dostupna su za samostalnu primjenu lijeka kod kuće.
English: • Prepare the injection solution: Remove the protective cap from the Luveris powder vial, pick up your syringe and slowly inject the solvent into the vial of Luveris.
Croatian: • Priprema otopine za injekciju: Uklonite zaštitni poklopac s Luveris bočice s praškom, podignite svoju štrcaljku i polako injicirajte otapalo u bočicu Luverisa.
English: What Luveris is
Croatian: Što je Luveris
English: Vascular disorders Very rare: Thromboembolism, usually associated with severe OHSS
Croatian: Krvožilni poremećaji Vrlo rijetko: Tromboembolija, obično povezana s teškim OHSS.
English: • Open the ampoule of solvent: On the head of the solvent ampoule, you will see a small coloured dot.
Croatian: • Otvaranje ampule s otapalom: Pri vrhu ampule s otapalom primijetit ćete malu obojanu točku.
English: Firmly pinch the skin together and insert the needle at a 45° to 90° angle using a dart-like motion.
Croatian: Čvrsto primite kožu prstima i uvedite iglu pod kutom od 45 ° do 90 ° kao da želite baciti strelicu pikada.
English: • The solvent is water for injection.
Croatian: • Otapalo je voda za injekcije.
English: After ovulation, LH stimulates progesterone production in the corpus luteum by increasing the conversion of cholesterol to pregnenolone.
Croatian: Nakon ovulacije LH stimulira nastanak progesterona u žutom tijelu povećanjem pretvorbe kolesterola u pregnenolon.
English: In clinical trials these patients were defined by an endogenous serum LH level <1.2 IU/l.
Croatian: U kliničkim ispitivanjima ti su bolesnici definirani endogenom razinom LH u serumu < 1,2 IU/l.
English: In LH and FSH deficient women, the objective of Luveris therapy in association with FSH is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of human chorionic gonadotropin (hCG).
Croatian: Kod žena s manjkom LH i FSH, cilj terapije Luverisom u kombinaciji s FSH je razvijanje jednog zrelog Graafovog folikula iz kojeg će oocita biti oslobođena nakon primjene humanog korionskog gonadotropina (hCG).
English: This could be due to parental factors (e.g. maternal age, genetics), ART procedures and multiple pregnancies.
Croatian: To može biti zbog roditeljskih utjecaja (primjerice, dob majke, genetika), procedura metoda potpomognute oplodnje i višeplodnih trudnoća.
English: The steady state volume of distribution is around 10-14 l. The mean residence time is approximately 5 hours.
Croatian: Volumen distribucije u stanju dinamičke ravnoteže iznosi oko 10-14 l.
English: Inject the solution by pushing gently on the plunger.
Croatian: Injicirajte otopinu nježno gurajući klip.
English: The powder must be reconstituted with the solvent before use by gentle swirling.
Croatian: Prašak se mora rekonstituirati s otapalom prije upotrebe blagim okretanjem.
English: Women with a history of tubal disease are at risk of ectopic pregnancy, whether the pregnancy is obtained by spontaneous conception or with fertility treatments.
Croatian: Žene s povijesti bolesti jajovoda izložene su riziku od ektopične trudnoće, bilo da je do trudnoće došlo spontanim začećem ili liječenjem neplodnosti.
English: Luveris is used for the stimulation of follicular development in association with follitropin alfa.
Croatian: Luveris se koristi za stimulaciju razvoja folikula zajedno s folitropinom alfa.
English: Do not use Luveris as a mixture with other medicines in the same injection, except for follitropin alfa, if prescribed by your doctor.
Croatian: Nemojte primjenjivati Luveris pomiješan s drugim lijekovima u istoj injekciji, osim s folitropinom alfa ako ga je propisao Vaš liječnik.
English: • fibroid tumours of the uterus incompatible with pregnancy
Croatian: • fibroidni tumori maternice nespojivi s trudnoćom.
English: Following subcutaneous administration, the terminal half-life is slightly prolonged.
Croatian: Nakon supkutane primjene, terminalni poluvijek blago je produljen.
English: In the ovaries, during the follicular phase, LH stimulates theca cells to secrete androgens, which will be used as the substrate by granulosa cell aromatase enzyme to produce estradiol, supporting FSH-induced follicular development.
Croatian: U jajnicima, tijekom folikularne faze, LH stimulira teka stanice na lučenje androgena koji se potom koriste kao supstrat enzima aromataze u granuloza stanicama kako bi se proizveo estradiol koji podržava razvoj folikula potaknut s FSH.