FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Ventavis (seen in more than 1 patient in 10) are headache, vasodilation (blood vessels becoming wider causing flushing or reddening of the face), bleeding episodes, chest pain and discomfort, peripheral oedema (swelling, especially of the ankles and feet), nausea (feeling sick), pain in the jaw and contraction of the jaw muscles, and cough.
Croatian: Najčešće nuspojave lijeka Ventavis (uočene kod više od 1 na 10 bolesnika) su glavobolja, vazodilatacija (proširenje krvnih žila što uzrokuje zajapurenost ili crvenilo lica), epizode krvarenja, bol i nelagoda u prsnom košu, periferni edem (oticanje, posebice gležnjeva i stopala), mučnina, bol u čeljusti i grč mišića čeljusti te kašalj.
English: Ventavis is used for the treatment of adult patients with class III primary pulmonary hypertension to improve exercise capacity (the ability to carry out physical activity) and symptoms.
Croatian: Ventavis se koristi za liječenje odraslih bolesnika s primarnom plućnom hipertenzijom klase III radi poboljšanja kapaciteta tjelesne aktivnosti (sposobnost obavljanja tjelesne aktivnosti) i ublažavanja simptoma.
English: Ventavis has been compared with placebo (a dummy treatment) in one study involving 203 adults with stable class III or IV pulmonary hypertension that was either primary or caused by another condition.
Croatian: Ventavis je uspoređen s placebom (prividno liječenje) u jednom ispitivanju koje je uključivalo 203 odrasle osobe sa stabilnom plućnom hipertenzijom klase III ili IV koja je bila ili primarna ili uzrokovana drugim zdravstvenim stanjem.
English: Ventavis is a medicine that contains the active substance iloprost.
Croatian: Ventavis je lijek koji sadrži djelatnu tvar iloprost.
English: Ventavis is given by inhalation using a nebuliser (a special machine that changes the solution into an aerosol that the patient can breathe in).
Croatian: Ventavis se daje inhalacijom pomoću atomizatora (posebnog uređaja koji mijenja otopinu u aerosol koji bolesnik može udisati).
English: A risk management plan has been developed to ensure that Ventavis is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Ventavis.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ventavis.
Croatian: Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek Ventavis da bi izdalo mišljenje u korist davanja odobrenja za stavljanje u promet i preporučilo uvjete za njegovu primjenu.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ventavis, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Ventavis nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Ventavis must not be used in patients who are at risk of bleeding, who have certain heart problems, who have recently had a stroke, or whose pulmonary hypertension is caused by a blocked or narrow vein.
Croatian: Ventavis se ne smije koristiti u bolesnika koji su izloženi riziku od krvarenja, koji imaju određenih problema sa srcem, koji su nedavno doživjeli moždani udar ili čija je plućna hipertenzija uzrokovana začepljenjem ili suženjem vene.
English: Pulmonary hypertension is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs that causes high blood pressure in the vessels taking blood from the right side of the heart to the lungs.
Croatian: Plućna hipertenzija je onesposobljavajuća bolest koja se odlikuje jakom konstrikcijom (suženjem) krvnih žila pluća što uzrokuje visoki krvni tlak u žilama koje odvode krv iz desne strane srca u pluća.
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).
Croatian: Ventavis je inhalirana formula iloprosta, tvari koja je vrlo slična prostaciklinu, prirodnoj molekuli koja uzrokuje dilataciju (širenje) krvnih žila.
English: It is available as a solution for inhalation using a nebuliser.
Croatian: Dostupan je kao otopina za inhalaciju pomoću atomizatora.
English: What is Ventavis?
Croatian: Što je Ventavis?
English: The CHMP decided that Ventavis's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) odlučilo je da koristi od lijeka Ventavis nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za stavljanje u promet.
English: ‘Primary' means that there are no other diseases of the heart or lungs causing the high blood pressure, and the ‘class' reflects the severity of the symptoms caused by the disease: ‘class III' involves marked limitation of physical activity.
Croatian: Plućna hipertenzija je nenormalno visoki krvni tlak u arterijama pluća. „Primarna” znači da ne postoje druge bolesti srca ili pluća koje uzrokuje visoki krvni tlak, a „klasa” odražava težinu simptoma koje uzrokuje bolest: „klasa III” uključuje značajno ograničenje tjelesne aktivnosti.
English: What is the risk associated with Ventavis?
Croatian: Koji su rizici povezani s lijekom Ventavis?
English: Why has Ventavis been approved?
Croatian: Zašto je Ventavis odobren?
English: What benefit has Ventavis shown during the studies?
Croatian: Koje su koristi lijeka Ventavis dokazane u ispitivanjima?
English: What is Ventavis used for?
Croatian: Za što se Ventavis koristi?
English: For the full list of all side effects reported with Ventavis, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Ventavis potražite u uputi o lijeku.
English: Ventavis was originally authorised under ‘exceptional circumstances' because, as the disease is rare, limited information was available at the time of approval.
Croatian: Ventavis je izvorno odobren u „iznimnim okolnostima”.
English: How is Ventavis used?
Croatian: Kako se Ventavis koristi?
English: How does Ventavis work?
Croatian: Kako djeluje Ventavis?
English: How has Ventavis been studied?
Croatian: Kako je Ventavis ispitivan?
English: Puregon is usually not effective in such cases.
Croatian: U takvim slučajevima Puregon obično nije učinkovit.
English: Treatment with Puregon and hCG should be continued for at least 3 to 4 months before any improvement in spermatogenesis can be expected.
Croatian: Liječenje lijekom Puregon i hCG-om se mora nastaviti najmanje 3 do 4 mjeseca prije nego se može očekivati bilo kakvo poboljšanje spermatogeneze.
English: You should not use Puregon if you are already pregnant, or think you might be pregnant.
Croatian: Ne smijete uzimati Puregon ako ste već trudni ili mislite da ste trudni.
English: What Puregon is and what it is used for
Croatian: Što je Puregon i za što se koristi
English: Other medicines and Puregon
Croatian: Drugi lijekovi i Puregon
English: Important information about some of the ingredients of Puregon
Croatian: Važne informacije o nekim sastojcima lijeka Puregon
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.
Croatian: Vaš liječnik će redovito provjeravati učinak liječenja kako bi iz dana u dan mogao odabrati pravilnu dozu lijeka Puregon.
English: What Puregon looks like and contents of the pack
Croatian: Kako Puregon izgleda i sadržaj pakiranja
English: When there are 30 or more follicles in total it is advised to withhold hCG administration.
Croatian: Kad je prisutno ukupno 30 ili više folikula, savjetuje se ne primijeniti hCG.
English: OHSS is a medical event distinct from uncomplicated ovarian enlargement.
Croatian: OHSS je medicinski događaj koji se razlikuje od nekompliciranog povećanja jajnika.
English: Date of first authorisation: 03 May 1996 Date of latest renewal: 29 May 2006
Croatian: Datum posljednje obnove: 29. svibnja 2006.
English: If you use more Puregon than you should
Croatian: Ako primijenite više lijeka Puregon nego što ste trebali
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.
Croatian: U istraživanjima ponovljenih doza na štakorima (2 tjedna) i psima (13 tjedana), pri dozama do 100 puta većima od maksimalne doze za ljude, Puregon nije izazvao značajne toksikološke učinke.
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).
Croatian: Klinička primjena lijeka Puregon intramuskularnim ili supkutanim putem može izazvati lokalne reakcije na mjestu injiciranja (u 3% svih liječenih bolesnika).
English: What Puregon contains
Croatian: Što Puregon sadrži
English: Start again with Step 1 using a new syringe, new needles and a new vial of Puregon.
Croatian: Krenite ponovno od Koraka 1 koristeći novu štrcaljku, nove igle i novu bočicu lijeka Puregon.
English: Self-administration of Puregon should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.
Croatian: Puregon si smiju davati samo bolesnici koji su dobro motivirani, primjereno obučeni i kojima je dostupan stručni savjet.
English: The first injection with Puregon should be performed under direct medical supervision.
Croatian: Prva injekcija lijeka Puregon mora se dati pod neposrednim medicinskim nadzorom.
English: What Puregon is and what it is used for What you need to know before you use Puregon How to use Puregon
Croatian: Što je Puregon i za što se koristi Što morate znati prije nego počnete primjenjivati Puregon Kako primjenjivati Puregon
English: Clinical experience with Puregon is based on up to three treatment cycles in both indications.
Croatian: Kliničko iskustvo s lijekom Puregon u obje se indikacije temelji na do tri ciklusa liječenja.
English: * Women who are not ovulating A starting dose is set by your doctor.
Croatian: * Žene koje nemaju ovulaciju Liječnik će odrediti početnu dozu.
English: Treatment with Puregon, just as pregnancy itself, may increase the risk of having a blood clot (thrombosis).
Croatian: Liječenje lijekom Puregon, baš kao i sama trudnoća, mogu povećati rizik od nastanka krvnog ugruška (tromboze).
English: Children There is no relevant use of PUREGON in children.
Croatian: Djeca Nema relevantne primjene lijeka Puregon u djece.
English: There are no significant pharmacokinetic differences between intramuscular and subcutaneous administration of Puregon.
Croatian: Nema značajnih farmakokinetičkih razlika između intramuskularne i supkutane primjene lijeka Puregon.
English: This leaflet was last revised in Month YYYY
Croatian: Ova uputa je zadnji puta revidirana u mjesec GGGG.
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.
Croatian: U žena s općenito prepoznatim rizičnim faktorima za tromboembolijske događaje, kao što je osobna ili obiteljska anamneza, jaka pretilost ili trombofilija, liječenje gonadotropinima, uključujući Puregon, može dalje povećati taj rizik.
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).
Croatian: Na kraju, držite štrcaljku uspravno s iglom prema gore i nježno lupkajte po tijelu štrcaljke kako bi mogući mjehurići zraka došli na vrh; tada potisnite klip dok ne izbacite sav zrak i u štrcaljki ne ostane samo Puregon otopina (d).
English: Single-dose administration of Puregon to rats induced no toxicologically significant effects.
Croatian: Primjena jedne doze lijeka Puregon u štakora nije izazvala značajne toksikološke učinke.
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.
Croatian: Nema dostupnih podataka o akutnoj toksičnosti lijeka Puregon u ljudi, ali je u istraživanjima na životinjama pokazano da je akutna toksičnost lijeka Puregon i urinarnih gonadotropina vrlo niska.
English: In adult females: Puregon is indicated for the treatment of female infertility in the following clinical situations:
Croatian: U odraslih žena: Puregon je indiciran za liječenje ženske neplodnosti u sljedećim kliničkim stanjima:
English: The very first injection of Puregon should only be given in the presence of a doctor or nurse.
Croatian: Prva injekcija lijeka Puregon smije se dati samo u prisustvu liječnika ili medicinske sestre.
English: Women with known risk factors for a high ovarian response may be especially prone to the development of OHSS during or following treatment with Puregeon.
Croatian: Žene s poznatim rizičnim faktorima za jaki odgovor jajnika mogu biti posebno sklone razvoju OHSS-a tijekom ili nakon liječenja lijekom Puregon.
English: Paediatric population There is no relevant use of Puregon in the paediatric population for the approved indication.
Croatian: Pedijatrijska populacija Nije opravdana primjena lijeka Puregon u pedijatrijskoj populaciji za odobrenu indikaciju.
English: What you need to know before you use Puregon
Croatian: Što morate znati prije nego počnete primjenjivati Puregon
English: Puregon solution for injection (injection) is a clear, colourless liquid.
Croatian: Puregon otopina za injekciju (injekcija) je bistra, bezbojna tekućina.
English: Puregon is unlikely to affect your ability to drive or use machines.
Croatian: Nije vjerojatno da će Puregon utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
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).
Croatian: Na temelju rezultata komparativnih kliničkih ispitivanja smatra se prikladnijim davati nižu ukupnu dozu lijeka Puregon tijekom kraćeg razdoblja liječenja nego što je uobičajeno kod primjene urinarnog FSH-a, ne samo radi optimalnog razvoja folikula, nego i kako bi se smanjio rizik od neželjene hiperstimulacije jajnika (vidjeti dio 5.1).
English: • Puregon may contain traces of streptomycin and/or neomycin.
Croatian: • Puregon može sadržavati streptomicin i/ili neomicin u tragovima.
English: In these women the benefits of gonadotropin administration, including Puregon, need to be weighed against the risks.
Croatian: U tih žena potrebno je odvagnuti koristi primjene gonadotropina, uključujući Puregon, u odnosu na rizike.
English: The absolute bioavailability of subcutaneously administered Puregon is approximately 77%.
Croatian: Apsolutna bioraspoloživost lijeka Puregon nakon supkutane primjene iznosi oko 77%.
English: Puregon may affect milk production.
Croatian: Puregon može utjecati na stvaranje mlijeka.
English: Median duration of treatment (days)
Croatian: Medijan ukupne doze (IU) Medijan trajanja liječenja (dani)
English: The active substance is follitropin beta.
Croatian: Djelatna tvar je folitropin beta.
English: In women undergoing assisted reproduction techniques, including in vitro fertilisation (IVF) and other methods, Puregon can bring about the development of multiple follicles.
Croatian: U žena koje su uključene u postupke medicinski potpomognute oplodnje, uključujući izvantjelesnu oplodnju (IVF) i druge metode, Puregon može dovesti do razvoja većeg broja folikula.
English: Talk to your doctor before using Puregon if you:
Croatian: Obratite se svom liječniku prije nego primijenite Puregon:
English: It is not known if treatment with fertility medicines increases the risk of these tumors in infertile women.
Croatian: Nije poznato povećava li liječenje lijekovima za plodnost rizik od tih tumora u neplodnih žena.
English: Puregon has no or negligible influence on the ability to drive and use machines.
Croatian: Puregon ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Elevated endogeneous FSH levels in men are indicative of primary testicular failure.
Croatian: Povišene koncentracije endogenog FSH-a u muškaraca ukazuju na primarno zatajenje testisa.
English: To reduce the risk of OHSS, ultrasonographic assessments of follicular development should be performed prior to treatment and at regular intervals during treatment.
Croatian: Kako bi se smanjio rizik od OHSS-a, potrebne su ultrazvučne procjene razvoja folikula prije liječenja i u redovitim vremenskim razmacima tijekom liječenja.
English: After treatment with gonadotrophin preparations, there is an increased chance of having multiple pregnancies, even when only one embryo is transferred into the uterus.
Croatian: Nakon liječenja preparatima gonadotropina, povećava se vjerojatnost višeplodne trudnoće, čak i kad se u maternicu prenese samo jedan zametak.
English: A sequential treatment scheme is recommended starting with daily administration of 50 IU Puregon.
Croatian: Preporučuje se postupna shema liječenja koja počinje primjenom 50 IU lijeka Puregon na dan.
English: Puregon can thus be used to stimulate follicular development and steroid production in selected cases of disturbed gonadal function.
Croatian: Puregon se stoga može koristiti za stimulaciju folikularnog razvoja i proizvodnju steroida u određenim slučajevima poremećaja funkcije spolnih žlijezda.
English: Do not use Puregon after the expiry date which is stated on the label and carton after 'EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake "EXP".
English: If you inject yourself with Puregon, follow the instructions carefully to give Puregonproperly and with minimal discomfort.
Croatian: Ako sami injicirate Puregon, pažljivo slijedite upute kako biste Puregon primijenili pravilno i uz minimalnu nelagodu.
English: If you forget to use Puregon
Croatian: Ako ste zaboravili primijeniti Puregon
English: Distribution, biotransformation and elimination Recombinant FSH is biochemically very similar to urinary human FSH and is distributed, metabolised, and excreted in the same way.
Croatian: Rekombinantni FSH biokemijski je vrlo sličan ljudskom urinarnom FHS pa se distribuira, metabolizira i izlučuje na isti način.
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.
Croatian: U kliničkim ispitivanjima u kojima se uspoređivala primjena rekombinantnog FSH-a (folitropin beta) i urinarnog FSH-a za kontroliranu stimulaciju jajnika u žena uključenih u postupak medicinski potpomognute oplodnje i za poticanje ovulacije (vidjeti tablice 1 i 2 u nastavku), Puregon se pokazao potentnijim od urinarnog FSH-a u smislu manje ukupne doze i kraćeg trajanja liječenja potrebnog za poticanje folikularnog sazrijevanja.
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.
Croatian: Nakon liječenja lijekom Puregon obično slijedi primjena hCG-a kako bi se potaknula posljednja faza sazrijevanja folikula, ponovna uspostava mejoze i ruptura folikula.
English: Treatment with Puregon should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Croatian: Liječenje lijekom Puregon mora započeti pod nadzorom liječnika s iskustvom u liječenju problema neplodnosti.
English: Puregon is used to treat infertility in any of the following situations:
Croatian: Puregon se koristi za liječenje neplodnosti u sljedećim situacijama:
English: Puregon solution for injection contains follitropin beta, a hormone known as follicle-stimulating hormone (FSH).
Croatian: Puregon otopina za injekciju sadrži folitropin beta, hormon poznat kao folikulostimulirajući hormon (FSH).
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.
Croatian: Ovisno o odgovoru jajnika, mogu se razmotriti sljedeće mjere kako bi se smanjio OHSS: - prekid daljnje stimulacije gonadotropinom tijekom maksimalno 3 dana (odgađanjeengl. coasting); - neprimjenjivanje hCG-a i otkazivanje terapijskog ciklusa; - primjena doze manje od 10 000 IU urinarnog hCG-a za poticanje konačnog sazrijevanja oocite, npr. 5000 IU urinarnog hCG-a ili 250 mikrograma rec-hCG-a (što odgovara približno 6500 IU urinarnog hCG-a); - otkazivanje prijenosa svježeg embrija i krioprezervacija embrija; - izbjegavanje primjene hCG-a za potporu lutealne faze.
English: Do not mix Puregon with any other medicines.
Croatian: Puregon se ne smije miješati s drugim lijekovima.
English: After intramuscular administration of Puregon, the maximum FSH concentrations are higher and reached earlier in men as compared to women.
Croatian: Nakon intramuskularne primjene lijeka Puregon maksimalne koncentracije FSH-a su veće i postižu se brže u muškaraca nego u žena.
English: * Medically assisted reproduction programs, for instance IVF A starting dose is set by your doctor.
Croatian: * Postupci medicinski potpomognute oplodnje, npr. izvantjelesna oplodnja (IVF) Liječnik će odrediti početnu dozu.
English: These side effects are not considered to be related to the use of Puregon, but to Assisted Reproductive Technology (ART) or subsequent pregnancy.
Croatian: Te se nuspojave ne smatraju povezanima s primjenom lijeka Puregon nego s medicinski potpomognutom oplodnjom ili posljedičnom trudnoćom.
English: Subcutaneous injection of Puregon may be carried out by patient or partner, provided that proper instructions are given by the physician.
Croatian: Supkutanu injekciju lijeka Puregon može primijeniti sam bolesnik/bolesnica ili partner/partnerica ako im je liječnik dao odgovarajuće upute.
English: Intramuscular (IM) and subcutaneous (SC) use The contents of the vial should be used immediately after piercing of the rubber stopper.
Croatian: Primjena u mišić (i.m.) ili potkožno (s.c.) Sadržaj bočice mora se upotrijebiti odmah nakon što se probije gumeni čep.
English: Do not use Puregon
Croatian: Nemojte primjenjivati Puregon
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.
Croatian: Kod uporabe injekcijske brizgalice treba znati da je brizgalica precizno pomagalo koje injicira točnu dozu koja je odmjerena.
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).
Croatian: Tablica 1: Rezultati Ispitivanja 37 608 (randomizirano, grupno komparativno kliničko ispitivanje usporedbe sigurnosti i djelotvornosti lijeka Puregon i urinarnog FSH-a u kontroliranoj stimulaciji jajnika).