FrancophonIA/ELRC3.0 huggingface dataset:
English: (EU/1/00/155/001-003) One vial of solvent contains: 1 ml water for injection.
Slovenian: (EU/1/00/155/001-003) Ena viala z vehiklom vsebuje: 1 ml vode za injekcije.
English: ATC code: G03GA07
Slovenian: Oznaka ATC: G03GA07
English: Please contact your doctor.
Slovenian: Posvetujte se z zdravnikom.
English: It is essentially “sodium free”.
Slovenian: To v bistvu pomeni „brez natrija“.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, gonadotropins.
Slovenian: Farmakoterapevtska skupina: spolni hormoni in modulatorji genitalnega sistema, gonadotropini.
English: The steady state volume of distribution is around 10-14 l. The mean residence time is approximately 5 hours.
Slovenian: Volumen porazdelitve v stanju dinamičnega ravnovesja je približno 10-14 l. Srednji čas zadrževanja je približno 5 ur.
English: Consult your doctor to find out if a more suitable alternative may be available for you.
Slovenian: Posvetujte se z zdravnikom, katere primernejše možnosti so vam na voljo.
English: Although these adverse reactions were not observed, there is the possibility that they may also occur with Luveris.
Slovenian: Čeprav teh neželenih reakcij niso opazili, obstaja možnost, da se pojavijo tudi pri uporabi zdravila Luveris.
English: Other studies have shown that lutropin alfa is not mutagenic.
Slovenian: Druge študije so pokazale, da lutropin alfa ni mutagen.
English: It is not yet established whether or not treatment with gonadotropins increases the risk of these tumours in infertile women.
Slovenian: Ni še ugotovljeno, ali zdravljenje z gonadotropini zvišuje tveganje za te tumorje pri neplodnih ženskah.
English: Ovarian Hyper-Stimulation Syndrome (OHSS) was observed in less than 6 % of patients treated with Luveris.
Slovenian: Sindrom hiperstimulacije jajčnikov (OHSS) so opazili pri manj kot 6 % bolnic, ki so se zdravile z zdravilom Luveris.
English: Total body clearance is around 2 l/h with less than 5 % of the dose being excreted in the urine.
Slovenian: Celokupni očistek je približno 2 l/h in manj kot 5 % odmerka se izloči z urinom.
English: No severe injection site reactions were reported.
Slovenian: O hudih reakcijah na mestu injiciranja niso poročali.
English: Do not use Luveris:
Slovenian: Ne uporabljajte zdravila Luveris:
English: Tumours of sexual organs
Slovenian: Tumorji na spolnih organih
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.
Slovenian: Ko uporabljate zdravilo Luveris, obstaja večje tveganje za nosečnost z več kot enim otrokom hkrati („večplodna nosečnost“, predvsem dvojčki), kot če bi zanosili po naravni poti.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 29. november 2000.
English: The first injection of Luveris should be performed under direct medical supervision.
Slovenian: Prvo injekcijo zdravila Luveris je treba dati pod neposrednim zdravniškim nadzorom.
English: You can reduce the risk of multiple pregnancy by using the right dose of Luveris at the right times.
Slovenian: Tveganje za večplodno nosečnost lahko zmanjšate z uporabo pravilnega odmerka zdravila Luveris ob pravem času.
English: In these women, the benefits of gonadotropin administration need to be weighed against the risks.
Slovenian: Pri teh ženskah je treba oceniti koristi uporabe gonadotropina glede na tveganja.
English: If you forget to use Luveris Do not use a double dose to make up for a forgotten dose.
Slovenian: Če ste pozabili uporabiti zdravilo Luveris Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
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.
Slovenian: Kot je bilo pričakovati zaradi heterologne proteinske narave hormona, je lutropin alfa povečal odziv protiteles pri poskusnih živalih po obdobju, v katerem so se zmanjšale merljive serumske vrednosti LH, vendar ni popolnoma preprečil njegovega biološkega delovanja.
English: Tell your doctor before you start treatment, if you or any member of your family have porphyria (an inability to break down porphyrins that may be passed on from parents to children).
Slovenian: Pred začetkom zdravljenja zdravniku povejte, če imate vi ali član vaše družine porfirijo (nezmožnost razgradnje porfirinov, ki je lahko dedna).
English: Do not use Luveris if any of the above applies to you.
Slovenian: Zdravila Luveris ne uporabljajte, če kaj od zgoraj navedenega velja za vas.
English: Treatment with Luveris should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Slovenian: Zdravljenje z zdravilom Luveris se mora začeti pod nadzorom zdravnika, ki je izkušen v zdravljenju težav s plodnostjo.
English: 1082 MA Amsterdam The Netherlands
Slovenian: 1082 MA Amsterdam
English: You may be at a higher risk of serious blood clots or existing clots might become worse with Luveris treatment.
Slovenian: Morda je pri vas tveganje za pojav resnih krvnih strdkov večje ali pa se obstoječi strdki lahko poslabšajo ob jemanju zdravila Luveris.
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.
Slovenian: Ne uporabljajte tega zdravila, če opazite vidne znake kvarjenja, kot so sprememba barve praška ali poškodovan vsebnik.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Carefully set the syringe down on the work-surface, taking care not to touch the needle.
Slovenian: Brizgo previdno položite na delovno površino in pri tem pazite, da se ne dotaknete igle.
English: It is more commonly seen in women with polycystic ovarian syndrome and usually regresses without treatment.
Slovenian: Pogosteje se pojavi pri ženskah s sindromom policističnih jajčnikov in se običajno odpravi brez zdravljenja.
English: Luveris must not be used when a condition exists which would make a normal pregnancy impossible, such as:
Slovenian: Zdravila Luveris ni dovoljeno uporabljati v pogojih, ki bi onemogočili normalno nosečnost, na primer:
English: Monitoring of stimulation cycles by ultrasound scans as well as estradiol measurements are recommended to early identify risk factors.
Slovenian: Priporočeni so nadzorovanje ciklov stimulacije z ultrazvokom ter meritve estradiola za zgodnje odkrivanje dejavnikov tveganja.
English: Deterioration or a first appearance of this condition may require cessation of treatment.
Slovenian: V primerih poslabšanja ali ob prvih znakih te motnje bo morda potrebno zdravljenje prekiniti.
English: 37.5-75 IU at 7 to 14-day intervals.
Slovenian: 75 i.e., v 7- do 14-dnevnih časovnih razmakih.
English: To minimise the risk of higher order multiple pregnancy, careful monitoring of ovarian response is recommended.
Slovenian: Za zmanjšanje tveganja večplodne nosečnosti visokega reda priporočamo podrobno spremljanje odziva jajčnikov.
English: The medicine should be administered immediately after dissolving the powder.
Slovenian: Zdravilo morate injicirati takoj po raztapljanju praška.
English: Allergic reactions such as rash, red skin, hives, swelling of your face with difficulty breathing can sometimes be serious.
Slovenian: Alergijske reakcije, kot so izpuščaji, pordela koža, koprivnica, oteklina obraza z oteženim dihanjem, so včasih lahko hude.
English: The effects of an overdose of Luveris are unknown.
Slovenian: Učinki prevelikega odmerka zdravila Luveris niso poznani.
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.
Slovenian: Obstajajo dokazi, da ima hCG pomembno vlogo pri sprožanju OHSS ter da bi bil sindrom hujši in bi trajal dalj časa, če bi prišlo do nosečnosti.
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).
Slovenian: • če ste alergični na gonadotropine (kot so luteinizirajoči hormon, folikle stimulirajoči hormon ali humani horionski gonadotropin) ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
English: It belongs to the family of hormones called gonadotropins, which are involved in the normal control of reproduction.
Slovenian: Spada v družino hormonov, ki se imenujejo gonadotropini in predstavljajo sestavni del normalnega uravnavanja reprodukcije.
English: Luveris treatment seldom causes severe OHSS.
Slovenian: Zdravljenje z zdravilom Luveris redko povzroči hud OHSS.
English: Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.
Slovenian: Poškodbe jajčnika zaradi slabše prekrvavitve lahko omejimo z zgodnjo diagnozo in takojšnjo detorzijo.
English: • hypersensitivity to active substances or to any of the excipients listed in section 6.1.
Slovenian: • s preobčutljivostjo na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1
English: What you need to know before you use Luveris
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Luveris
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.
Slovenian: Pri ženskah z nedavno ali trenutno prisotno trombembolično boleznijo ali pri ženskah s splošno znanim dejavnikom tveganja za trombembolične dogodke, na primer v anamnezi ali v družinski anamnezi, ter pri ženskah s trombofilijo ali hudo debelostjo (indeks telesne mase > 30 kg/m2) lahko zdravljenje z gonadotropini dodatno zviša tveganje za poslabšanje ali prisotnost takih dogodkov.
English: • Serious blood clotting complications (thromboembolic events) usually with severe OHSS are found very rarely.
Slovenian: • Hudi zapleti strjevanja krvi (trombembolični dogodki) običajno s hudim OHSS, se pojavijo zelo redko.
English: Gently push the plunger until the air bubbles are gone.
Slovenian: Nežno potiskajte bat, dokler zračni mehurčki ne izginejo.
English: Luveris is intended for subcutaneous use which means it is given by injection under the skin.
Slovenian: Zdravilo Luveris je namenjeno za subkutano uporabo, kar pomeni, da se ga injicira pod kožo.
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.
Slovenian: Zdravilo Luveris se priporoča za zdravljenje odraslih žensk, za katere se je izkazalo, da tvorijo zelo majhne količine nekaterih hormonov, ki predstavljajo del naravnega reproduktivnega ciklusa.
English: In distinction to uncomplicated ovarian enlargement, OHSS is a condition that can manifest itself with increasing degrees of severity.
Slovenian: V nasprotju z nekompliciranim povečanjem jajčnikov je OHSS stanje, ki se lahko kaže s stopnjevanjem resnosti.
English: Treatment should recommence in the next cycle at a dose of FSH lower than that of the previous cycle.
Slovenian: Ponovno zdravljenje v naslednjem ciklusu se mora začeti z nižjim odmerkom FSH-ja kot v predhodnem ciklusu.
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.
Slovenian: Če se razvije huda oblika OHSS, priporočamo, da zdravljenje z gonadotropini, če to še traja, ustavite in da bolnico hospitalizirate ter začnete z ustrezno terapijo.
English: Via delle Magnolie 15 (Zona industriale) I-70026 Modugno (Bari) Italy
Slovenian: Via delle Magnolie 15 (Zona industriale) I-70026 Modugno (Bari) Italija
English: Alternatively, intrauterine insemination (IUI) may be performed.
Slovenian: Alternativno se lahko izvede intrauterina osemenitev (IUI).
English: Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and oestrogen response.
Slovenian: Zdravljenje mora biti prilagojeno individualnemu odzivu bolnice, katerega ovrednotimo z merjenjem velikosti folikla z ultrazvokom in estrogenskega odziva.
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.
Slovenian: • Odstranite vse uporabljene predmete: ko ste zaključili z vbrizgavanjem, takoj odstranite vse igle in prazne steklene vsebnike v zaščitno posodo, ki je priložena.
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”).
Slovenian: Vaši jajčniki so se morda prekomerno odzvali na zdravljenje in razvile so se velike vrečke s tekočino ali ciste (glejte tudi poglavje 2 „Sindrom hiperstimulacije jajčnikov“).
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.
Slovenian: Težave s strjevanjem krvi (trombembolični dogodki) Pred uporabo zdravila Luveris se posvetujte z zdravnikom, če ste vi ali član vaše družine kdaj imeli krvne strdke v nogi ali pljučih ali če ste vi ali član vaše družine kdaj doživeli srčni napad ali kap.
English: Ovarian torsion has been reported after treatment with other gonadotropins.
Slovenian: O zasuku jajčnika so poročali po zdravljenju z ostalimi gonadotropini.
English: This could cause chest pain, breathlessness, stroke or heart attack (see also in section 2 under “Blood clotting problems”).
Slovenian: Ti povzročajo bolečine v prsnem košu, težko dihanje, kap ali srčni napad (glejte tudi poglavje 2 „Težave s strjevanjem krvi“).
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.
Slovenian: Če se pri vas razvije OHSS, vam zdravnik v tem ciklusu zdravljenja morda ne bo dal hCG in vam bo naročil, da v obdobju najmanj štirih dni nimate spolnih odnosov ali da v tem času uporabljate mehanska kontracepcijska sredstva.
English: Other medicines and Luveris
Slovenian: Druga zdravila in zdravilo Luveris
English: For the following cycle, your doctor will prescribe FSH at a lower dose than that of the previous cycle.
Slovenian: Za naslednji ciklus vam bo zdravnik predpisal manjši odmerek FSH kot v predhodnem ciklusu.
English: Multiple pregnancy, especially high order, carry an increased risk of adverse maternal and perinatal outcomes.
Slovenian: Večplodna nosečnost, zlasti visokega reda, predstavlja povečano tveganje za neželen izid nosečnosti za mater in otroka.
English: This side effect is very rare (may affect up to 1 in 10,000 people).
Slovenian: Ti neželeni učinki so zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov).
English: Safety, efficacy, and pharmacokinetics of Luveris in patients with renal or hepatic impairment have not been established.
Slovenian: Varnost, učinkovitost in farmakokinetika zdravila Luveris pri bolnikih z ledvično ali jetrno okvaro niso bile dokazane.
English: Important information about some of the ingredients of Luveris Luveris contains less than 1 mmol sodium (23 mg) per dose.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Luveris Zdravilo Luveris vsebuje manj kot 1 mmol (23 mg) natrija na odmerek.
English: Luveris is contraindicated in patients with:
Slovenian: Zdravilo Luveris je kontraindicirano pri bolnicah:
English: • ovarian enlargement or ovarian cyst unrelated to polycystic ovarian disease and of unknown origin
Slovenian: • s povečanjem jajčnikov ali cisto jajčnikov, ki ni povezana s policistično boleznijo ovarijev in je neznanega izvora
English: Following intravenous administration, lutropin alfa is rapidly distributed with an initial half-life of approximately one hour.
Slovenian: Po intravenskem dajanju se lutropin alfa hitro porazdeli z začetnim razpolovnim časom približno 1 uro.
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).
Slovenian: To postane bolj verjetno, če jemljete zdravilo, ki se uporablja za sprožitev končnega folikularnega zorenja (ki vsebuje humani horionski gonadotropin, hCG) (za podrobnosti glejte poglavje 3 „Koliko zdravila uporabiti“.
English: Safety and effectiveness of Luveris in elderly patients have not been established.
Slovenian: Varnost in učinkovitost zdravila Luveris pri starejših bolnikih nista bili dokazani.
English: Directly below it is where the neck of the ampoule has been treated to make it easier to break.
Slovenian: Direktno pod njo je vrat ampule, ki je obdelan tako, da ga je najlažje zlomiti.
English: Following subcutaneous administration, the terminal half-life is slightly prolonged.
Slovenian: Po subkutanem dajanju je končni razpolovni čas rahlo podaljšan.
English: In patients with porphyria or a family history of porphyria Luveris may increase the risk of an acute attack.
Slovenian: Pri bolnicah s porfirijo ali pri bolnicah, ki imajo porfirijo v družini, lahko zdravilo Luveris poveča tveganje za akutni napad.
English: If an excessive response is obtained, treatment should be stopped and hCG withheld (see section ‘Possible Side Effects').
Slovenian: Če pride do čezmernega odziva, je treba zdravljenje prekiniti in opustiti hCG (glejte poglavje „Možni neželeni učinki“).
English: One ampoule of solvent contains: 1 ml water for injection.
Slovenian: Ena ampula z vehiklom vsebuje: 1 ml vode za injekcije.
English: If you are not sure, talk to your doctor or pharmacist before using this medicine.
Slovenian: Če niste prepričani, se pred uporabo zdravila pogovorite z zdravnikom ali farmacevtom.
English: One vial of powder for injection contains 75 IU (International Units).
Slovenian: Ena viala s praškom za injiciranje vsebuje 75 i.e. (internacionalne enote).
English: Luveris is usually used every day for up to three weeks simultaneously with injections of FSH.
Slovenian: Zdravilo Luveris je treba jemati vsak dan največ tri tedne skupaj z injekcijami FSH.
English: • The active substance is lutropin alfa.
Slovenian: • Zdravilna učinkovina je lutropin alfa.
English: • gynaecological haemorrhages of unknown origin
Slovenian: • z ginekološkimi krvavitvami neznanega izvora
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”).
Slovenian: Če občutite bolečino v spodnjem delu trebuha, hitro pridobite na telesni masi, vam je slabo ali bruhate ali če je vaše dihanje oteženo, se takoj pogovorite z zdravnikom, ki vam bo morda naročil, da prenehate jemati to zdravilo (glejte poglavje 4 „ Resni neželeni učinki“).
English: Name and address of the manufacturer responsible for batch release Merck Serono S.p.A.
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij Merck Serono S.p.A.
English: • ovarian, uterine, or mammary carcinoma
Slovenian: • z ovarijskim, materničnim karcinomom ali karcinomom dojke
English: Following subcutaneous administration of Luveris, lutropin alfa is eliminated from the body with a terminal half-life of about 10-12 hours.
Slovenian: Po subkutanem dajanju zdravila Luveris se lutropin alfa izloči iz telesa s končnim razpolovnim časom približno 10-12 ur.
English: The powder is packaged in 3 ml neutral colourless glass (type I) vials.
Slovenian: Prašek je pakiran v 3 ml viale iz nevtralnega brezbarvnega stekla (tip I).
English: This leaflet was last revised in .
Slovenian: Navodilo je bilo nazadnje revidirano dne {MM/LLLL}
English: Clinical evaluation may reveal signs such as hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, pleural effusions, or acute pulmonary distress.
Slovenian: Klinični pregled lahko pokaže znake, kot so hipovolemija, hemokoncentracija, elektrolitsko neravnovesje, ascites, plevralni izliv ali akutna pulmonalna stiska.
English: If you administer Luveris to yourself, please carefully read the following instructions: • Wash your hands.
Slovenian: Če si sami dajete zdravilo Luveris, vas prosimo, da natančno preberete naslednja navodila:
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.
Slovenian: Samostojni dejavniki tveganja za razvoj OHSS vključujejo mlada leta, mršavo telesno maso, sindrom policističnih jajčnikov, večje odmerke eksogenih gonadotropinov, visoke absolutne ali hitro rastoče ravni serumskega estradiola in predhodno pojavljanje OHSS, veliko število razvijajočih se ovarijskih foliklov in veliko število oocitov v ciklusih ART.
English: What Luveris is and what it is used for
Slovenian: Kaj je zdravilo Luveris in za kaj ga uporabljamo
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.
Slovenian: Zdravila Luveris ne smemo dajati kot mešanico z drugimi zdravili v isti injekcijski brizgi, razen s folitropinom alfa, za katerega so študije pokazale, da njegovo sočasno dajanje ne spremeni pomembno učinka, stabilnosti, farmakokinetičnih ali farmakodinamičnih lastnosti zdravilnih učinkovin.
English: Carefully place the open ampoule upright on the worksurface.
Slovenian: Odprto ampulo previdno položite v pokončnem položaju na delovno površino.
English: Lutropin alfa shows linear pharmacokinetics, as assessed by area under curve (AUC) which is directly proportional to the dose administered.
Slovenian: Lutropin alfa izkazuje linearno farmakokinetiko, kot so ocenili s površino pod krivuljo (AUC), ki je direktno sorazmerna danemu odmerku.
English: Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated.
Slovenian: Pred začetkom zdravljenja je treba primerno oceniti neplodnost para in ovrednotiti domnevne kontraindikacije za nosečnost.
English: • The solvent is water for injection.
Slovenian: • Vehikel je voda za injekcije.
English: Vascular disorders Very rare: Thromboembolism, usually associated with severe OHSS
Slovenian: Žilne bolezni Zelo redki: trombembolija, običajno povezana s hudim OHSS
English: Inspect for particles as before, and do not use if the solution is not clear.
Slovenian: Enako kot prej, raztopino preglejte na prisotnost delcev in je ne uporabite, če ni bistra.
English: Immune system disorders Very rare: Mild to severe hypersensitivity reactions including anaphylactic reactions and shock.
Slovenian: Bolezni imunskega sistema Zelo redki: blaga do huda preobčutljivostna reakcija, vključno z anafilaktičnimi reakcijami in šokom
English: Nervous system disorders Common: Headache
Slovenian: Bolezni živčevja Pogosti: glavobol
English: However, drug-related teratogenesis was not observed in either animal model.
Slovenian: Vendar pa pri nobenem od živalskih modelov niso opazili z zdravilom povezane teratogenosti.