FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should start with the low dose of 2.5 micrograms for the first inhalation, and if the first dose is well tolerated, the second and consecutive doses should be 5 micrograms.
Slovenian: Bolniki morajo pri prvem vdihavanju uporabiti nizki 2,5-mikrogramski odmerek, čemur sledi 5-mikrogramski odmerek za drugo vdihavanje in vsa nadaljnja vdihavanja, če bolnik prvi odmerek dobro prenaša.
English: What is the risk associated with Ventavis?
Slovenian: Kakšna tveganja so povezana z zdravilom Ventavis?
English: Ventavis is an inhaled formulation of iloprost, a substance that is very similar to prostacyclin, a naturally occurring molecule that causes blood vessels to dilate (expand).
Slovenian: Zdravilo Ventavis je inhalacijska formulacija iloprosta, tj. učinkovine, ki je zelo podobna prostaciklinunaravno prisotni molekuli, ki povzroča dilatacijo (širjenje) krvnih žil.
English: Why has Ventavis been approved?
Slovenian: Zakaj je bilo zdravilo Ventavis odobreno?
English: How has Ventavis been studied?
Slovenian: Kako je bilo zdravilo Ventavis raziskano?
English: What is Ventavis?
Slovenian: Kaj je zdravilo Ventavis?
English: How does Ventavis work?
Slovenian: Kako zdravilo Ventavis deluje?
English: What is Ventavis used for?
Slovenian: Za kaj se zdravilo Ventavis uporablja?
English: How is Ventavis used?
Slovenian: Kako se zdravilo Ventavis uporablja?
English: Date of first authorisation: 03 May 1996 Date of latest renewal: 29 May 2006
Slovenian: Datum prve odobritve: 3. maj 1996 Datum zadnjega podaljšanja: 29. maj 2006
English: SN: NN:
Slovenian: PC: SN: NN:
English: Puregon is usually not effective in such cases.
Slovenian: V takih primerih zdravilo Puregon običajno ni učinkovito.
English: Clinical experience with Puregon is based on up to three treatment cycles in both indications.
Slovenian: Klinične izkušnje z zdravilom Puregon temeljijo na treh ciklusih zdravljenja za obe indikaciji.
English: Restricted to women with ovulation induced (Puregon, n = 76; u-FSH, n = 42).
Slovenian: Omejeno na ženske s sproženo ovulacijo (Puregon, n = 76; u-FSH, n = 42).
English: Your doctor will check the effects of the treatment regularly to be able to choose the correct dose of Puregon from day to day.
Slovenian: Zdravnik bo redno preverjal učinke zdravljenja, da bo lahko izbral pravilen odmerek zdravila Puregon za vsak dan posebej.
English: Clinical use of Puregon by the intramuscular or subcutaneous routes may lead to local reactions at the site of injection (3% of all patients treated).
Slovenian: Klinična uporaba zdravila Puregon intramuskularno ali subkutano lahko povzroči lokalne reakcije na mestu injiciranja (pri 3 % vseh zdravljenih bolnikov).
English: The use of Puregon during pregnancy is not indicated.
Slovenian: Uporaba zdravila Puregon med nosečnostjo ni indicirana.
English: Important information about some of the ingredients of Puregon
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Puregon
English: You should not use Puregon if you are already pregnant, or think you might be pregnant.
Slovenian: Zdravila Puregon ne smete uporabljati, če ste noseči ali menite, da bi lahko bili noseči.
English: In repeated-dose studies in rats (two weeks) and dogs (13 weeks) up to 100-fold the maximal human dose, Puregon induced no toxicologically significant effects.
Slovenian: V študijah s ponavljajočimi se odmerki pri podganah (dvotedenskih) in psih (13-tedenskih) z odmerki, ki so bili 100-krat večji od največjega odmerka za človeka, zdravilo Puregon ni povzročilo nobenih pomembnih toksikoloških učinkov.
English: * Women who are not ovulating A starting dose is set by your doctor.
Slovenian: • Ženske, ki nimajo ovulacije Začetni odmerek določi zdravnik.
English: In adult females: Puregon is indicated for the treatment of female infertility in the following clinical situations:
Slovenian: Pri odraslih ženskah: Zdravilo Puregon je indicirano za zdravljenje neplodnosti pri ženskah v naslednjih kliničnih primerih:
English: What Puregon is and what it is used for
Slovenian: Kaj je zdravilo Puregon in za kaj ga uporabljamo
English: Paediatric population There is no relevant use of Puregon in the paediatric population for the approved indication.
Slovenian: Pediatrična populacija Ustrezne uporabe zdravila Puregon v pediatrični populaciji za odobreno indikacijo ni.
English: Other medicines and Puregon
Slovenian: Druga zdravila in zdravilo Puregon
English: Treatment with Puregon, just as pregnancy itself, may increase the risk of having a blood clot (thrombosis).
Slovenian: Zdravljenje z zdravilom Puregon, prav tako kot sama nosečnost, lahko poveča tveganje za krvni strdek (trombozo).
English: The absolute bioavailability of subcutaneously administered Puregon is approximately 77%.
Slovenian: Absolutna biološka razpoložljivost subkutano danega zdravila Puregon je približno 77 %.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI) ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: This may be of particular relevance when switching between the pen-injector and a conventional syringe within one treatment cycle.
Slovenian: To je lahko še posebej pomembno pri prehodu z navadne brizge na peresnik v času enega ciklusa terapije.
English: In women with generally recognised risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia, treatment with gonadotropins, including Puregon, may further increase this risk.
Slovenian: Pri ženskah s splošno znanimi dejavniki tveganja za trombembolične dogodke, npr. z osebno ali družinsko anamnezo, hudo debelostjo ali trombofilijo, lahko zdravljenje z gonadotropini, vključno z zdravilom Puregon, dodatno poveča takšno tveganje.
English: Based on the results of comparative clinical studies, it is considered appropriate to give a lower total dosage of Puregon over a shorter treatment period than generally used for urinary FSH, not only in order to optimise follicular development but also to reduce the risk of unwanted ovarian hyperstimulation (see section 5.1).
Slovenian: Na osnovi rezultatov primerjalnih kliničnih študij se je izkazalo, da je primernejše dati manjše celotne odmerke zdravila Puregon v krajšem obdobju zdravljenja, kot se običajno dajejo pri urinskem FSH, ne le z namenom optimizacije razvoja folikla temveč tudi za zmanjšanje tveganja za neželeno hiperstimulacijo jajčnikov (glejte poglavje 5.1).
English: Puregon has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Puregon nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Treatment with Puregon should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Slovenian: Zdravljenje z zdravilom Puregon je treba začeti pod nadzorom zdravnika, izkušenega na področju zdravljenja neplodnosti.
English: Start again with Step 1 using a new syringe, new needles and a new vial of Puregon.
Slovenian: Potem spet začnite s prvim korakom, pri tem pa uporabite novo brizgo, nove igle in novo vialo zdravila Puregon.
English: No data on acute toxicity of Puregon in humans is available, but the acute toxicity of Puregon and of urinary gonadotrophin preparations in animal studies has been shown to be very low.
Slovenian: Podatkov o akutni toksičnosti zdravila Puregon pri ljudeh ni na voljo, vendar so poskusi na živalih pokazali, da je akutna toksičnost zdravila Puregon in urinskih gonadotropinov zelo majhna.
English: * Medically assisted reproduction programs, for instance IVF A starting dose is set by your doctor.
Slovenian: • Programi oploditve z biomedicinsko pomočjo, na primer IVF Začetni odmerek določi zdravnik.
English: It is not known if treatment with fertility medicines increases the risk of these tumors in infertile women.
Slovenian: Ni znano, ali zdravljenje z zdravili za plodnost poveča tveganje za takšne tumorje pri neplodnih ženskah.
English: When there are 30 or more follicles in total it is advised to withhold hCG administration.
Slovenian: Če je skupno število foliklov 30 ali več, je priporočljivo, da ženska ne dobi hCG.
English: To reduce the risk of OHSS, ultrasonographic assessments of follicular development should be performed prior to treatment and at regular intervals during treatment.
Slovenian: Za zmanjšanje tveganja za OHSS je treba razvoj foliklov ocenjevati z ultrazvočnimi preiskavami pred zdravljenjem in v rednih presledkih med zdravljenjem.
English: When using the pen-injector, it should be realised that the pen is a precision device which accurately delivers the dose to which it is set.
Slovenian: Pri uporabi injekcijskega peresnika je treba upoštevati, da je peresnik natančen pripomoček, ki natančno injicira nastavljeni odmerek.
English: If you forget to use Puregon
Slovenian: Če ste pozabili uporabiti zdravilo Puregon
English: Do not use Puregon after the expiry date which is stated on the label and carton after 'EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake ‘EXP'.
English: Single-dose administration of Puregon to rats induced no toxicologically significant effects.
Slovenian: Enkraten odmerek zdravila Puregon pri podganah ni povzročil pomembnih toksikoloških učinkov.
English: Puregon can thus be used to stimulate follicular development and steroid production in selected cases of disturbed gonadal function.
Slovenian: Zdravilo Puregon se torej lahko uporablja za spoodbujanje razvoja foliklov in tvorbe steroidov v izbranih primerih, kjer je moteno delovanje gonad.
English: After subcutaneous administration of Puregon, maximum concentration of FSH is reached within about 12 hours.
Slovenian: Po subkutanem dajanju zdravila Puregon je maksimalna koncentracija FSH dosežena v času približno 12 ur.
English: In these women the benefits of gonadotropin administration, including Puregon, need to be weighed against the risks.
Slovenian: Pri teh ženskah je treba koristi uporabe gonadotropinov, vključno z zdravilom Puregon, pretehtati v primerjavi s tveganji.
English: What you need to know before you use Puregon
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Puregon
English: If you use more Puregon than you should
Slovenian: Če ste uporabili večji odmerek zdravila Puregon, kot bi smeli
English: Puregon is usually prescribed at a dose of 450 IU per week, mostly in 3 dosages of 150 IU, in combination with another hormone (hCG), for at least 3 to 4 months.
Slovenian: Zdravilo Puregon se običajno predpisuje v odmerku 450 i.e. na teden; večinoma v 3 odmerkih po 150 i.e. v kombinaciji z drugim hormonom (hCG), najmanj 3 do 4 mesece.
English: Puregon solution for injection (injection) is a clear, colourless liquid.
Slovenian: Puregon raztopina za injiciranje (injekcija) je bistra, brezbarvna tekočina.
English: Elevated endogeneous FSH levels in men are indicative of primary testicular failure.
Slovenian: Zvišane vrednosti endogenega FSH pri moških so znak primarne odpovedi testisov.
English: In women undergoing assisted reproduction techniques, including in vitro fertilisation (IVF) and other methods, Puregon can bring about the development of multiple follicles.
Slovenian: Pri ženskah, ki so v postopku oploditve z biomedicinsko pomočjo, vključno z zunajtelesno oploditvijo (IVF - in vitro fertilisation) in drugimi metodami, zdravilo Puregon lahko povzroči razvoj večkratnih foliklov.
English: • Puregon may contain traces of streptomycin and/or neomycin.
Slovenian: • Zdravilo Puregon lahko vsebuje sledi streptomicina in/ali neomicina.
English: If you: • are allergic to follitropin beta or any of the other ingredients of Puregon (listed in section 6)
Slovenian: • če ste alergični na folitropin beta ali katero koli sestavino zdravila Puregon (navedeno v poglavju 6),
English: Self-administration of Puregon should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.
Slovenian: Bolniki si lahko zdravilo Puregon dajejo sami le, če so motivirani, primerno poučeni in imajo možnost posvetovati se s strokovnjakom.
English: It is unlikely that Puregon is passed into breast milk.
Slovenian: Malo verjetno je, da bi zdravilo Puregon prehajalo v materino mleko.
English: Puregon is unlikely to affect your ability to drive or use machines.
Slovenian: Malo verjetno je, da bi zdravilo Puregon vplivalo na vašo sposobnost vožnje in upravljanja strojev.
English: What Puregon is and what it is used for What you need to know before you use Puregon How to use Puregon
Slovenian: Kaj je zdravilo Puregon in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Puregon Kako uporabljati zdravilo Puregon Možni neželeni učinki
English: In clinical studies comparing recFSH (follitropin beta) and urinary FSH for controlled ovarian stimulation in women participating in an assisted reproduction technology (ART) program and for ovulation induction (see tables 1 and 2 below), Puregon was more potent than urinary FSH in terms of a lower total dose and a shorter treatment period needed to trigger follicular maturation.
Slovenian: V kliničnih študijah, kjer so primerjali uporabo rekombinantnega FSH (folitropina beta) in urinskega FSH za nadzorovano stimulacijo jajčnikov pri ženskah, ki so sodelovale v programu oploditve z biomedicinsko pomočjo in za indukcijo ovulacije (glejte preglednici 1 in 2 spodaj), je bilo zdravilo Puregon učinkovitejše od urinskega FSH v smislu manjšega celotnega odmerka in krajšega obdobja zdravljenja, ki je bilo potrebno za začetek zorenja foliklov.
English: This leaflet was last revised in Month YYYY
Slovenian: Navodilo je bilo nazadnje revidirano dne
English: Due to the relatively long elimination half-life, repeated administration of the same dose will lead to plasma concentrations of FSH that are approximately 1.5-2.5 times higher than after single dose administration.
Slovenian: Zaradi relativno dolgega razpolovnega časa izločanja vodi ponovno dajanje enakega odmerka do plazemskih koncentracij FSH, ki so približno 1,5 do 2,5-krat večje od koncentracij po enkratnem odmerku.
English: To prevent painful injections and minimise leakage from the injection site Puregon should be slowly administered intramuscularly or subcutaneously.
Slovenian: Da preprečite bolečino in zmanjšate iztekanje na mestu injiciranja, je treba zdravilo Puregon dati bolniku počasi intramuskularno ali subkutano.
English: Water for injections.
Slovenian: benzilalkohol vodo za injekcije.
English: If Puregon is used in a combination with clomifene citrate, the effect of Puregon may be increased.
Slovenian: Če uporabljate zdravilo Puregon v kombinaciji s klomifenijevim citratom, se učinek zdravila Puregon lahko poveča.
English: A sequential treatment scheme is recommended starting with daily administration of 50 IU Puregon.
Slovenian: Priporočamo postopno shemo zdravljenja, ki se začne z odmerki 50 i.e. zdravila Puregon na dan.
English: The first injection with Puregon should be performed under direct medical supervision.
Slovenian: Prvo injekcijo zdravila Puregon morajo bolniki prejeti pod neposrednim zdravniškim nadzorom.
English: Puregon is used in the treatment of women undergoing ovarian induction or controlled ovarian hyperstimulation in assisted reproduction programmes.
Slovenian: Zdravilo Puregon uporabljamo za zdravljenje žensk v postopku indukcije ovulacije ali nadzorovane hiperstimulacije jajčnikov v programih oploditve z biomedicinsko pomočjo.
English: Treatment with Puregon is generally followed by administration of hCG to induce the final phase of follicle maturation, resumption of meiosis and rupture of the follicle.
Slovenian: Zdravljenju z zdravilom Puregon običajno sledi dajanje hCG, da se sproži zadnja stopnja zorenja folikla, ponovitev mejoze in pretrganje folikla.
English: In men who are infertile due to lowered hormone levels, Puregon can be used for the production of sperm.
Slovenian: Pri moških, ki so neplodni zaradi zmanjšane koncentracije hormonov, se zdravilo Puregon lahko uporablja za nastajanje sperme.
English: Table 2: Results of study 37,609 (randomized, group comparative clinical study comparing safety and efficacy of Puregon with urinary FSH in ovulation induction).
Slovenian: Preglednica 2: Izsledki Študije 37.609 (randomizirana primerjalna klinična študija v kateri so varnost in učinkovitost zdravila Puregon primerjali z urinskim FSH pri indukciji ovulacije).
English: Polysorbate 20
Slovenian: L-metionin polisorbat 20
English: Finally hold the syringe with the needle pointing upwards and gently tap the side to force any air bubbles up to the top; then squeeze the plunger until all the air has been expelled, and only Puregon solution is left in the syringe (d).
Slovenian: Brizgo primite tako, da bo injekcijska igla obrnjena navzgor, in nežno potrkajte po brizgi, da morebitni zračni mehurčki splavajo na vrh; nato potisnite bat toliko, da iz brizge iztisnete ves zrak in v njej ostane le raztopina zdravila Puregon (d).
English: Medical conditions that contraindicate pregnancy should also be evaluated before starting treatment with Puregon.
Slovenian: Pred začetkom zdravljenja z zdravilom Puregon je treba oceniti tudi bolezenska stanja, pri katerih je nosečnost kontraindicirana.
English: If you inject yourself with Puregon, follow the instructions for use in the next section, to give Puregon properly and with minimal discomfort.
Slovenian: Če si boste sami injicirali zdravilo Puregon, upoštevajte navodila za uporabo, ki so podana v naslednjem poglavju, da si boste zdravilo Puregon dali pravilno in z najmanj neugodja.
English: Too high a dose of Puregon may cause hyperstimulation of the ovaries (OHSS).
Slovenian: Prevelik odmerek zdravila Puregon lahko povzroči preveliko stimulacijo jajčnikov (OHSS).
English: The active substance is follitropin beta.
Slovenian: Zdravilna učinkovina je folitropin beta.
English: Do not use Puregon
Slovenian: Ne uporabljajte zdravila Puregon
English: Table 1: Results of study 37,608 (randomized, group comparative clinical study comparing safety and efficacy of Puregon with urinary FSH in controlled ovarian stimulation).
Slovenian: Preglednica 1: Izsledki Študije 37.608 (randomizirana primerjalna klinična študija v kateri so varnost in učinkovitost zdravila Puregon primerjali z urinskim FSH pri nadzorovani stimulaciji jajčnikov).
English: Puregon cartridges are not designed to allow any other drug to be mixed in the cartridges.
Slovenian: Vložki Puregon niso namenjeni za mešanje katerega koli drugega zdravila v vložku.
English: Do not mix Puregon with any other medicines.
Slovenian: Zdravila Puregon ne smete mešati z drugimi zdravili.
English: If you are breast-feeding, tell your doctor before using Puregon.
Slovenian: Če dojite, morate to povedati zdravniku, preden začnete uporabljati zdravilo Puregon.
English: Concomitant use of Puregon and clomifene citrate may enhance the follicular response.
Slovenian: Sočasna uporaba zdravila Puregon in klomifenijevega citrata lahko poveča odziv foliklov.
English: Depending on the ovarian response, the following measurements can be considered to reduce OHSS: - withhold further stimulation with a gonadotropin for a maximum of 3 days (coasting); - withhold hCG and cancel the treatment cycle; - administer a dose lower than 10,000 IU of urinary hCG for triggering final oocyte maturation, e.g. 5,000 IU urinary hCG or 250 micrograms rec-hCG (which is equivalent to approximately 6,500 IU of urinary hCG); - cancel the fresh embryo transfer and cryopreserve embryos; - avoid administration of hCG for luteal phase support.
Slovenian: Odvisno od odziva jajčnikov pridejo za zmanjšanje možnosti za OHSS v poštev naslednji ukrepi: - odložitev nadaljnje stimulacije z gonadotropinom za največ 3 dni, - neuporaba hCG in opustitev ciklusa zdravljenja, - uporaba urinskega hCG v odmerku, manjšem od 10.000 i.e., za sprožitev končnega dozorevanja oocitov, npr. 5.000 i.e. urinskega hCG ali 250 mikrogramov rec-hCG (to ustreza približno 6.500 i.e. urinskega hCG), - opustitev prenosa svežega zarodka in krioprezervacija zarodka, - neuporaba hCG za podporo lutealne faze.
English: Children There is no relevant use of PUREGON in children.
Slovenian: Otroci Pri otrocih zdravilo Puregon nima ustrezne uporabe.
English: What Puregon looks like and contents of the pack
Slovenian: Izgled zdravila Puregon in vsebina pakiranja
English: In women who do not ovulate and do not respond to treatment with clomifene citrate, Puregon can be used to cause ovulation.
Slovenian: Pri ženskah, ki nimajo ovulacije in pri katerih je bilo zdravljenje s klomifenijevim citratom neuspešno, uporabljamo zdravilo Puregon za sprožitev ovulacije.
English: The very first injection of Puregon should only be given in the presence of a doctor or nurse.
Slovenian: Prvo injekcijo zdravila Puregon smete prejeti le pod nadzorom zdravnika ali medicinske sestre.
English: Puregon is used to treat infertility in any of the following situations:
Slovenian: Zdravilo Puregon uporabljamo za zdravljenje neplodnosti v katerem koli od naslednjih primerov:
English: After intramuscular administration of Puregon, the maximum FSH concentrations are higher and reached earlier in men as compared to women.
Slovenian: Po intramuskularnem dajanju se pri moških maksimalne koncentracije FSH pojavijo hitreje, njihova vrednost pa je večja kot pri ženskah.
English: Puregon can be given either alone, or, to prevent premature luteinisation, in combination with a GnRH agonist or antagonist.
Slovenian: Zdravilo Puregon lahko dajete kot monoterapijo ali v kombinaciji z agonistom ali antagonistom GnRH za preprečitev prezgodnje luteinizacije.
English: How to use Puregon
Slovenian: Kako uporabljati zdravilo Puregon
English: Using the pen, injection of Puregon can be carried out by the patient, provided that proper instructions are given by the physician.
Slovenian: Z uporabo peresnika lahko zdravilo Puregon injicira bolnik, če od zdravnika dobi ustrezna navodila.
English: For patient convenience, Puregon may be stored at or below 25ºC by the patient for a single period of not more than 3 months.
Slovenian: Zaradi lažje uporabe lahko bolnik zdravilo Puregon shranjuje pri temperaturi do 25 ºC, vendar ne več kot 3 mesece.
English: If you inject yourself with Puregon, follow the instructions carefully to give Puregonproperly and with minimal discomfort.
Slovenian: Če si boste sami injicirali zdravilo Puregon, upoštevajte navodila, da si boste zdravilo Puregon dali pravilno in z najmanj neugodja.
English: In males Puregon is used in the treatment of deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Slovenian: Pri moških uporabljamo zdravilo Puregon za zdravljenje zmanjšane spermatogeneze zaradi hipogonadotropnega hipogonadizma.
English: Puregon solution for injection contains follitropin beta, a hormone known as follicle-stimulating hormone (FSH).
Slovenian: Puregon raztopina za injiciranje vsebuje folitropin beta, hormon, ki je poznan kot folikle stimulirajoči hormon (FSH).
English: Such patients are unresponsive to Puregon/hCG therapy.
Slovenian: Taki bolniki se na zdravljenje z zdravilom Puregon in s hCG ne odzivajo.
English: These side effects are not considered to be related to the use of Puregon, but to Assisted Reproductive Technology (ART) or subsequent pregnancy.
Slovenian: Ti neželeni učinki ne veljajo za z zdravilom Puregon povezane neželene učinke, temveč za povezane s postopki oploditve z biomedicinsko pomočjo ali s poznejšo nosečnostjo.
English: There are no significant pharmacokinetic differences between intramuscular and subcutaneous administration of Puregon.
Slovenian: Med intramuskularno in subkutano uporabo zdravila Puregon ni pomembnih farmakokinetičnih razlik.
English: In rare instances, thromboembolism has been associated with follitropin beta /hCG therapy as with other gonadotrophins.
Slovenian: Tako kot zdravljenje z drugimi gonadotropini je bilo tudi zdravljenje s folitropinom beta/hCG v redkih primerih povezano s tromboembolizmom.