FrancophonIA/ELRC3.0 huggingface dataset:
English: Luveris is usually used every day for up to three weeks simultaneously with injections of FSH.
Croatian: Luveris se obično koristi svaki dan do tri tjedna istovremeno s injekcijama FSH.
English: This leaflet was last revised in .
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG}
English: • According to your response, your doctor may increase your dose of FSH by preferably
Croatian: • U skladu s Vašim odgovorom, Vaš liječnik može povećati Vašu dozu FSH po mogućnosti za
English: ATC code: G03GA07
Croatian: ATK oznaka: G03GA07
English: Do not use Luveris:
Croatian: Nemojte primjenjivati Luveris:
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, gonadotropins.
Croatian: Farmakoterapijska skupina: Spolni hormoni i modulatori genitalnog sustava, gonadotropini.
English: This medicine stimulates your ovaries.
Croatian: Ovaj lijek stimulira jajnike.
English: The first injection of Luveris should be performed under direct medical supervision.
Croatian: Prvu injekciju lijeka Luveris treba dati pod izravnim medicinskim nadzorom.
English: (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), frequency not known (cannot be estimated from the available data).
Croatian: Učestalost pojavljivanja opisana je sljedećom terminologijom u daljnjem tekstu: vrlo često (≥ 1/10), cesto (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), učestalost nepoznata (ne može se procijeniti iz dostupnih podataka).
English: What Luveris looks like and contents of the pack
Croatian: Kako Luveris izgleda i sadržaj pakiranja
English: Treatment should recommence in the next cycle at a dose of FSH lower than that of the previous cycle.
Croatian: Liječenje treba ponovo započeti u idućem ciklusu s dozom FSH manjom u odnosu na prethodni ciklus.
English: Do not use Luveris if any of the above applies to you.
Croatian: Nemojte primjenjivati Luveris ako se bilo što od navedenog odnosi na Vas.
English: Luveris is contraindicated in patients with:
Croatian: Luveris je kontraindiciran u pacijentica koje imaju:
English: Since these patients are amenorrhoeic and have low endogenous oestrogen secretion, treatment can commence at any time.
Croatian: Budući da ove pacijentice imaju amenoreju i smanjeno lučenje endogenog estrogena, terapija se može započeti u bilo kojem trenutku.
English: For the following cycle, your doctor will prescribe FSH at a lower dose than that of the previous cycle.
Croatian: Za sljedeći ciklus Vaš liječnik će Vam propisati FSH u nižoj dozi od one u prethodnom ciklusu.
English: In patients with porphyria or a family history of porphyria Luveris may increase the risk of an acute attack.
Croatian: U pacijenata s porfirijom ili obiteljskom anamnezom porfirije Luveris može povećati rizik od akutnog udara.
English: Carefully set the syringe down on the work-surface, taking care not to touch the needle.
Croatian: Pažljivo položite štrcaljku na radnu površinu pazeći da ne dotaknete iglu.
English: Other studies have shown that lutropin alfa is not mutagenic.
Croatian: Druga ispitivanja su pokazala da lutropin alfa nije mutagen.
English: 1082 MA Amsterdam The Netherlands
Croatian: 1082 MA Amsterdam
English: You may be at a higher risk of serious blood clots or existing clots might become worse with Luveris treatment.
Croatian: Možete biti pod većim rizikom od ozbiljnih krvnih ugrušaka ili se postojeći ugrušci mogu pogoršati liječenjem lijekom Luveris.
English: This LH/CG transmembrane receptor is a member of the super-family of G proteincoupled receptors; specifically, it has a large extra-cellular domain.
Croatian: Ovaj transmembranski receptor LH/CG je član nadređene obitelji receptora udruženih s G proteinom; specifična mu je značajka velika izvanstanična domena.
English: However, drug-related teratogenesis was not observed in either animal model.
Croatian: Međutim, nije uočena teratogeneza povezana s lijekom ni na jednom životinjskom modelu.
English: • hypersensitivity to active substances or to any of the excipients listed in section 6.1.
Croatian: • preosjetljivost na djelatnu tvar ili na neku od pomoćnih tvari navedenih u dijelu 6.1.
English: What Luveris is and what it is used for What you need to know before you use Luveris How to use Luveris
Croatian: Što je Luveris i za što se koristi Što morate znati prije nego počnete primjenjivati Luveris Kako primjenjivati Luveris
English: • Serious blood clotting complications (thromboembolic events) usually with severe OHSS are found very rarely.
Croatian: • Ozbiljne komplikacije zgrušavanja krvi (tromboembolijski događaji) obično s teškim OHSS događaju se vrlo rijetko.
English: Absorption Following subcutaneous administration, the absolute bioavailability is approximately 60 %.
Croatian: Apsorpcija Nakon supkutane primjene, apsolutna bioraspoloživost iznosi približno 60%.
English: One vial of powder for injection contains 75 IU (International Units).
Croatian: Jedna bočica praška za injekciju sadrži 75 IU (međunarodnih jedinica).
English: Allergic reactions such as rash, red skin, hives, swelling of your face with difficulty breathing can sometimes be serious.
Croatian: Alergijske reakcije kao što su osip, crvenilo kože, koprivnjača, otekline lica i poteškoće pri disanju katkada mogu biti ozbiljne.
English: When using Luveris, 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: Za vrijeme liječenja Luverisom pod povećanim ste rizikom od trudnoće s više od jednim djetetom u isto vrijeme („višeplodna trudnoća“, uglavnom blizanci) nego da začnete prirodnim putem.
English: Luveris treatment seldom causes severe OHSS.
Croatian: Liječenje Luverisom rijetko uzrokuje teški OHSS.
English: Tumours of sexual organs
Croatian: Tumori spolnih organa
English: Non clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti.
English: This side effect is very rare (may affect up to 1 in 10,000 people).
Croatian: Ta je nuspojava vrlo rijetka (može se pojaviti kod do 1 na 10 000 osoba).
English: Ovarian Hyper-Stimulation Syndrome (OHSS) was observed in less than 6 % of patients treated with Luveris.
Croatian: Sindrom hiperstimulacije jajnika (OHSS) uočen je u manje od 6% pacijentica koje su primale Luveris.
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 rizik za razvoj ovih tumora u neplodnih žena ili ne.
English: Gently push the plunger until the air bubbles are gone.
Croatian: Blago pogurajte klip sve dok ne nestanu mjehurići zraka.
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 who might ask you to stop using this medicine (see in section 4 under “Serious side effects”).
Croatian: Ako osjetite bol u donjem dijelu trbuha, dobijete naglo na težini, osjećate mučninu ili povraćate ili imate poteškoća u disanju odmah razgovarajte sa svojim liječnikom koji bi mogao od Vas tražiti da prekinete liječenje lijekom Luveris (pogledajte u dijelu 4 pod dijelom „Ozbiljne nuspojave“).
English: This could cause chest pain, breathlessness, stroke or heart attack (see also in section 2 under “Blood clotting problems”).
Croatian: To je moglo uzrokovati bol u prsima, nedostatak zraka, srčani ili moždani udar (pogledajte također u 2. poglavlju u „Problemi sa zgrušavanjem krvi“).
English: Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and oestrogen response.
Croatian: Liječenje treba prilagoditi individualnom odgovoru pacijentice koji se procjenjuje mjerenjem veličine folikula ultrazvukom i mjerenjem estrogenskog odgovora.
English: As expected from the heterologous protein nature of the hormone, lutropin alfa raised an antibody response in experimental animals after a period that reduced the measurable serum LH levels but did not fully prevent its biological action.
Croatian: Kako se očekuje od heterologne proteinske strukture hormona, lutropin alfa potaknuo je odgovor protutijela u eksperimentalnih životinja nakon razdoblja tijekom kojeg se smanjuju razine mjerljivog serumskog LH, ali nije u potpunosti spriječio njegovu biološku aktivnost.
English: Monitoring of stimulation cycles by ultrasound scans as well as estradiol measurements are recommended to early identify risk factors.
Croatian: Nadzor ciklusa stimulacije ultrazvukom kao i mjerenjima estradiola preporučuju se za utvrđivanje ranih čimbenika rizika.
English: There is evidence to suggest that hCG plays a key role in triggering OHSS and that the syndrome may be more severe and more protracted if pregnancy occurs.
Croatian: Postoje dokazi koji upućuju da hCG ima važnu ulogu u poticanju OHSS-a i da taj sindrom može postati teži te se produžiti ako dođe do trudnoće.
English: It is recommended not to use Luveris if you have any condition that usually makes a normal pregnancy impossible, such as ovaries that do not work because of a condition called primary ovarian failure, or malformations of sexual organs.
Croatian: Preporučuje se da ne koristite Luveris ako imate bilo koje stanje koje inače onemogućava normalnu trudnoću poput jajnika koji ne funkcioniraju zbog stanja zvanog primarno zatajenje jajnika ili malformacije spolnih organa.
English: Directly below it is where the neck of the ampoule has been treated to make it easier to break.
Croatian: Odmah je ispod mjesta gdje je vrat ampule obrađen kako bi je se lakše prelomilo.
English: If severe OHSS occurs, it is recommended that gonadotropin treatment be stopped if still ongoing and that the patient be hospitalised and appropriate therapy be started.
Croatian: Ako dođe do razvoja teškog oblika OHSS-a, liječenje gonadotropinima treba obustaviti ukoliko još traje, a pacijenticu hospitalizirati i započeti odgovarajuću terapiju.
English: You can reduce the risk of multiple pregnancy by using the right dose of Luveris at the right times.
Croatian: Rizik od višeplodne trudnoće može se smanjiti upotrebom prave doze Luverisa u pravo vrijeme.
English: The medicine should be administered immediately after dissolving the powder.
Croatian: Lijek treba primijeniti odmah nakon otapanja praška.
English: Luveris is intended for subcutaneous use which means it is given by injection under the skin.
Croatian: Luveris je namijenjen za potkožnu primjenu što znači da se daje injekcijom pod kožu.
English: Date of latest renewal: 30
Croatian: Datum posljednje obnove: 30. studenog 2005.
English: • If you are allergic to gonadotropins (such as luteinising hormone, follicle stimulating hormone or human chorionic gonadotropin), or any of the other ingredients of this medicine (listed in section 6).
Croatian: • Ako ste alergični na gonadotropine (poput luteinizirajućeg hormona, hormona koji stimulira folikule ili humanog korionskog gonadotropina) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: There is no pharmacokinetic interaction with follitropin alfa when administered simultaneously.
Croatian: Nema farmakokinetičke interakcije s folitropinom alfa kada se daju istovremeno.
English: When the desired response has been obtained, a single injection of hCG is given 24 to 48 hours after the last injections of Luveris and FSH.
Croatian: Kad se postigne željeni odgovor, daje se jedna injekcija hCG od 24 do 48 sati nakon zadnje injekcije Luverisa i FSH.
English: Total body clearance is around 2 l/h with less than 5 % of the dose being excreted in the urine.
Croatian: Ukupni tjelesni klirens je otprilike 2 l/h s manje od 5% izlučene doze u mokraći.
English: EU/1/00/155/001 (1 vial/ 1 ampoule) EU/1/00/155/002 (3 vials/ 3 ampoules) EU/1/00/155/003 (10 vials/ 10 ampoules) EU/1/00/155/004 (1 vial/ 1 vial) EU/1/00/155/005 (3 vial/ 3 vials) EU/1/00/155/006 (10 vials/ 10 vials)
Croatian: EU/1/00/155/001 (1 bočica/1 ampula) EU/1/00/155/002 (3 bočice/3 ampule) EU/1/00/155/003 (10 bočica/10 ampula) EU/1/00/155/004 (1 bočica/1 bočica) EU/1/00/155/005 (3 bočice/3 bočice) EU/1/00/155/006 (10 bočica/10 bočica)
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 gonadotropins may further increase the risk for aggravation or occurrence of such events.
Croatian: U žena s nedavnim ili trenutno prisutnim tromboembolijskim događajima ili u žena s općenito prepoznatim čimbenicima rizika za tromboembolijske događaje poput osobne ili obiteljske anamneze, trombofilije ili teške pretilosti (indeks tjelesne težine >30 kg/m2), liječenje gonadotropinima može dodatno povećati rizik od pogoršanja ili pojave takvih događaja.
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: Important information about some of the ingredients of Luveris Luveris contains less than 1 mmol sodium (23 mg) per dose.
Croatian: Važne informacije o nekim sastojcima lijeka Luveris Luveris sadrži manje od 1 mmol (23 mg) natrija po dozi.
English: Treatment with Luveris should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Croatian: Liječenje lijekom Luveris treba započeti pod nadzorom liječnika s iskustvom u liječenju problema plodnosti.
English: Consult your doctor to find out if a more suitable alternative may be available for you.
Croatian: Obratite se liječniku kako biste istražili povoljnije mogućnosti koje bi Vam mogle biti dostupne.
English: Single doses of up to 40,000 IU of lutropin alfa have been administered to healthy female volunteers without serious adverse reactions and were well tolerated.
Croatian: Pojedinačne doze od 40 000 IU lutropina alfa primjenjivane su na zdravim ženskim dobrovoljcima bez ozbiljnih nuspojava i dobro su se podnosile.
English: In these women, the benefits of gonadotropin administration need to be weighed against the risks.
Croatian: U ovih žena koristi primjene gonadotropina treba usporediti s rizicima.
English: To minimise the risk of higher order multiple pregnancy, careful monitoring of ovarian response is recommended.
Croatian: Za minimizaciju rizika od višeplodnih trudnoća s velikim brojem plodova preporučuje se pažljivi nadzor odgovora jajnika.
English: Your doctor will decide on the dose and schedule of administration, which are most appropriate for you during this course of treatment.
Croatian: Vaš će liječnik odlučiti o dozi i rasporedu primjene u skladu s onim što je najprikladnije za Vas tijekom ciklusa liječenja.
English: Following subcutaneous administration of Luveris, lutropin alfa is eliminated from the body with a terminal half-life of about 10-12 hours.
Croatian: Nakon supkutane primjene Luverisa, lutropin alfa se eliminira iz tijela s terminalnim poluvijekom od približno 10-12 sati.
English: What you need to know before you use Luveris
Croatian: Što morate znati prije nego počnete primjenjivati Luveris
English: No severe injection site reactions were reported.
Croatian: Teške reakcije na mjestu davanja injekcije nisu zabilježene.
English: Inspect for particles as before, and do not use if the solution is not clear.
Croatian: Kao i prethodno, provjerite ima li čestica i nemojte upotrebljavati ako otopina nije čista.
English: Your ovaries may have over-reacted to the treatment and formed large sacs of fluid or cysts (see also in section 2 under “Ovarian HyperStimulation Syndrome”).
Croatian: Vaši su jajnici možda prekomjerno reagirali na liječenje te su se stvorile velike vrećice s tekućinom ili ciste (pogledajte također u dijelu 2 pod „Sindrom hiperstimulacije jajnika“).
English: Luveris should not be administered as a mixture with other medicinal products, in the same injection, except follitropin alfa for which studies have shown that co-administration does not significantly alter the activity, stability, pharmacokinetic nor pharmacodynamic properties of the active substances.
Croatian: Luveris se ne smije primjenjivati kao mješavina s drugim lijekovima, u istoj injekciji osim folitropina alfa za kojeg su ispitivanja pokazala kako njegova istovremena primjena ne mijenja znatno aktivnost, stabilnost, farmakokinetiku ili farmakodinamička svojstva djelatnih tvari.
English: Carefully place the open ampoule upright on the worksurface.
Croatian: Pažljivo položite otvorenu ampulu u uspravnom položaju na radnu površinu.
English: There is no indication for the use of Luveris during pregnancy.
Croatian: Ne postoje indikacije za primjenu lijeka Luveris tijekom trudnoće.
English: What Luveris is and what it is used for
Croatian: Što je Luveris i za što se koristi
English: Do not use this medicine if you notice any visible signs of deterioration, such as discolouration of the powder or damage to the container.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite vidljive znakove kvarenja poput promjene boje praška ili oštećenje spremnika.
English: Your doctor will ensure careful monitoring of ovarian response, based on ultrasound and blood sampling before and during the course of treatment.
Croatian: Vaš liječnik će pomno nadzirati odgovor jajnika na temelju ultrazvuka i uzimanja uzoraka krvi prije i tijekom liječenja.
English: Luveris is intended for subcutaneous use.
Croatian: Luveris je namijenjen za supkutanu primjenu.
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 možda uputiti da se suzdržavate od spolnih odnosa ili koristite barijernu kontracepciju najmanje četiri dana.
English: Immune system disorders Very rare: Mild to severe hypersensitivity reactions including anaphylactic reactions and shock.
Croatian: Poremećaji imunološkog sustava Vrlo rijetko: Blage do teške reakcije preosjetljivosti uključujući anafilaktičke reakcije i šok.
English: This side effect is common (may affect up to 1 in 10 people).
Croatian: Ta je nuspojava česta (može se pojaviti kod do 1 na 10 osoba).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29
Croatian: DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
English: Following intravenous administration, lutropin alfa is rapidly distributed with an initial half-life of approximately one hour.
Croatian: Nakon intravenske primjene lutropin alfa se brzo distribuira s početnim poluvijekom od približno sat vremena.
English: In addition, patients should be evaluated for hypothyroidism, adrenocortical deficiency and hyperprolactinemia and appropriate specific treatment given.
Croatian: Pored toga pacijentice treba testirati na hipotiroidizam, adrenokortikalnu insuficijenciju i hiperprolaktinemiju te primijeniti odgovarajuće liječenje.
English: Appearance of the powder: white lyophilised pellet Appearance of the solvent: clear colourless solution The pH of the reconstituted solution is 7.5-8.5.
Croatian: Izgled otapala: bistra bezbojna otopina pH rekonstituirane otopine je 7,5-8,5.
English: Safety, efficacy, and pharmacokinetics of Luveris in patients with renal or hepatic impairment have not been established.
Croatian: Sigurnost, djelotvornost i farmakokinetika lijeka Luveris u pacijentica s oštećenjem jetre ili bubrega nisu ustanovljene.
English: Name and address of the manufacturer of the biological active substance Merck Serono SA
Croatian: Naziv i adresa proizvođača biološke djelatne tvari Merck Serono SA
English: If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7-14 day intervals and preferably by 37.5 IU-75 IU increments.
Croatian: Ako se utvrdi da je potrebno povećanje doze FSH, prilagodbu doze treba po mogućnosti provesti nakon intervala od 7-14 dana i po mogućnosti s povećanjima za 37,5 IU do 75 IU.
English: In vitro the affinity binding of recombinant hLH to the LH/CG receptor on Leydig tumour cells (MA-10) is between that for hCG and that of pituitary hLH, but within the same order of magnitude.
Croatian: In vitro afinitet vezivanja rekombinantnog hLH na LH/CG receptor tumorskih Leydigovih stanica (MA-10) je između onog za hCG i onog od hipofiznog hLH, ali unutar istog reda jačine.
English: Ovarian torsion has been reported after treatment with other gonadotropins.
Croatian: Postoje izvješća o torziji jajnika nakon liječenja ostalim gonadotropinima.
English: If you forget to use Luveris Do not use a double dose to make up for a forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: The vials are sealed with bromobutyl stoppers protected by aluminium seal rings and flip-off caps.
Croatian: Bočice su zatvorene bromobutilnim čepovima zaštićenim aluminijskim prstenovima i „flip-off“ zatvaračima.
English: When undergoing assisted reproductive technology or stimulation of your ovaries to produce eggs, you are more likely to have a miscarriage than the average woman.
Croatian: Kada se podvrgavate tehnikama medicinski potpomognute oplodnje ili stimulaciji jajnika zbog proizvodnje jajnih stanica, veća je vjerojatnost da ćete doživjeti spontani pobačaj nego kod prosječne žene.
English: Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.
Croatian: Oštećenje jajnika zbog smanjenje opskrbe krvlju može se ograničiti ranom dijagnozom i trenutačnim uklanjanjem torzije.
English: Data on a limited number of exposed pregnancies indicate no adverse reactions of gonadotropins on pregnancy, embryonal or foetal development, parturition or postnatal development following controlled ovarian stimulation.
Croatian: Podaci na ograničenom broju trudnica izloženih lijeku ne ukazuju na štetne događaje gonadotropina na trudnoću, embrionalni ili fetalni razvoj, porod ili postnatalni razvoj nakon kontrolirane stimulacije jajnika.
English: This becomes more likely if the medicine that is used for final follicular maturation (containing human Chorionic Gonadotropin, hCG) is administered (see in section 3 under “How much to use” for details).
Croatian: To postaje vjerojatnije ako se primjenjuje lijek koji se koristi za konačno sazrijevanje folikula (koji sadrže humani korionski gonadotropin, hCG) (za više pojedinosti pogledajte dio 3 „Koliko lijeka trebate primijeniti“).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 75 IU of lutropin alfa (recombinant human Luteinising Hormone {r-hLH}).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sadrži 75 IU lutropina alfa (rekombinantni humani luteinizirajući hormon {r-hLH}).
English: • The usual starting dose is 75 IU (1 vial) of Luveris together with 75 IU or 150 IU of FSH.
Croatian: • Uobičajena početna doza je 75 IU (1 bočica) Luverisa zajedno s 75 IU ili 150 IU FSH.
English: No signs of toxicity due to the development of antibodies to lutropin alfa were observed.
Croatian: Nisu uočeni znakovi toksičnosti zbog razvoja protutijela na lutropin alfa.
English: In a clinical trial, mild and moderate injection site reactions (bruising, pain, redness, itching or swelling) were reported in 7.4 % and 0.9 % of the injections, respectively.
Croatian: U kliničkom ispitivanju zabilježene su blage i umjerene reakcije na mjestu injiciranja (modrice, bol, crvenilo, svrbež ili oticanje) u 7,4% odnosno 0,9% danih injekcija.