FrancophonIA/ELRC3.0 huggingface dataset:
English: For adolescents with type 2 diabetes, the CHMP concluded that although safety and effectiveness had only been shown for type 1 diabetes, the results of studies carried out in adolescents with type 1 and other studies in adults with type 2 diabetes could be applied to adolescents with type 2.
Croatian: Kod adolescenata s dijabetesom tipa 2, CHMP je zaključio da, iako je sigurnost i djelotvornost lijeka prikazana samo za dijabetes tipa 1, mogu se primijeniti rezultati studija provedenih na adolescentima s dijabetesom tipa 1 i drugih studija na odraslim osobama s dijabetesom tipa 2. CHMP je odlučio da koristi od lijeka Tresiba nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Six other main studies involving 4,076 adults with type 2 diabetes compared Tresiba with insulin glargine, insulin detemir or sitagliptin (a medicine taken by mouth for type 2 diabetes).
Croatian: Drugih šest ispitivanja uključivalo je 4076 odraslih bolesnika s dijabetesom tipa 2 te je uspoređivalo Tresibu s inzulin glarginom, inzulinom detemirom ili sitagliptinom (lijekom koji se uzima peroralno za liječenje dijabetesa tipa 2).
English: What benefit has Tresiba shown during the studies?
Croatian: Koje su koristi lijeka Tresiba dokazane u ispitivanjima?
English: What is Tresiba used for?
Croatian: Za što se Tresiba koristi?
English: Patients were also given rapid-acting insulin at mealtimes.
Croatian: Bolesnicima je davan i inzulin brzog djelovanja u vrijeme obroka.
English: How is Tresiba used?
Croatian: Kako se Tresiba koristi?
English: How does Tresiba work?
Croatian: Kako djeluje Tresiba?
English: Tresiba is a replacement insulin that is very similar to the natural insulin with a difference that it is absorbed more slowly in the body and takes longer to reach its target.
Croatian: Razlika je u njegovoj sporijoj apsorpciji u tijelu, i dužem vremenu do postizanja cilja, što znači da Tresiba dulje djeluje.
English: How has Tresiba been studied?
Croatian: Kako je lijek Tresiba ispitivan?
English: You have two options:
Croatian: Imate dvije mogućnosti:
English: Your doctor will tell you when and how to do this.
Croatian: Liječnik će Vam reći kada i na koji način to možete učiniti.
English: * Differences between the 2 groups were statistically significant (p0.05).
Croatian: * Razlike između 2 skupine su bile statistički značajne (p  0,05).
English: • This medicine has been prescribed for you only.
Croatian: - Ovaj lijek je propisan samo Vama.
English: Your doctor or nurse will tell you where to inject.
Croatian: Liječnik ili medicinska sestra će Vam reći gdje možete injicirati.
English: However, to date, no particular malformative effect has been reported.
Croatian: Međutim, do danas nije prijavljen malformacijski učinak.
English: Blood clots can lead to serious medical conditions, such as:
Croatian: Krvni ugrušci mogu dovesti do ozbiljnih medicinskih stanja, kao što su:
English: The majority of these local reactions are mild and transient in nature.
Croatian: Većina tih lokalnih reakcija su blage i prolazne.
English: See also section 4 on possible side effects.
Croatian: Također pogledajte dio 4 o mogućim nuspojavama.
English: • are pregnant or think that you may be pregnant
Croatian: • ako ste trudni ili mislite da biste mogli biti trudni
English: If you are a man:
Croatian: Ako ste muškarac:
English: Fertavid is usually not effective in such cases.
Croatian: U takvim slučajevima Fertavid obično nije učinkovit.
English: • have been told by a doctor that pregnancy would be dangerous for you.
Croatian: • ako Vam je liječnik rekao da trudnoća za Vas može biti opasna.
English: Men with too much FSH in their blood
Croatian: Muškarci koji imaju previše FSH-a u krvi
English: You should not use Fertavid if you are already pregnant, or think you might be pregnant.
Croatian: Ne smijete uzimati Fertavid ako ste već trudni ili mislite da ste trudni.
English: Both have an absolute bioavailability of approximately 77%.
Croatian: U oba slučaja apsolutna bioraspoloživost iznosi oko 77%.
English: This makes it impossible to set a uniform dosage scheme.
Croatian: Zbog toga nije moguće postaviti jedinstvenu shemu doziranja.
English: It is possible to inject in other areas.
Croatian: Moguće je injekciju dati i na druga mjesta.
English: • if you, or anyone in your immediate family, have ever had a thrombosis
Croatian: • ako ste Vi ili netko u Vašoj užoj obitelji imali trombozu
English:  Contact your doctor.
Croatian:  Javite se liječniku.
English: Please discuss this with your doctor, before starting treatment, especially:
Croatian: Molimo razgovarajte o tome sa svojim liječnikom prije početka liječenja, a osobito:
English: Because of the risk of developing OHSS, patients should be monitored for at least two weeks after hCG administration.
Croatian: Zbog rizika od razvoja OHSS-a, bolesnice treba nadzirati najmanje dva tjedna nakon primjene hCG-a.
English: See warnings and precautions in section 2.
Croatian: Pogledajte upozorenja i mjere opreza u dijelu 2.
English: Treatment with Fertavid and hCG should be continued for at least 3 to 4 months before any improvement in spermatogenesis can be expected.
Croatian: Liječenje lijekom Fertavid i hCG-om se mora nastaviti najmanje 3 do 4 mjeseca prije nego se može očekivati bilo kakvo poboljšanje spermatogeneze.
English: In clinical studies it was shown that maintenance dosages ranging from 75-375 IU for six to twelve days are sufficient, although longer treatment may be necessary.
Croatian: U kliničkim ispitivanjima pokazalo se da su dovoljne doze održavanja u rasponu od 75-375 IU tijekom 6 do 12 dana, iako može biti potrebno i dulje liječenje.
English: • have had an allergic reaction to certain antibiotics (neomycin and/or streptomycin)
Croatian: • ako ste imali alergijsku reakciju na neke antibiotike (neomicin i/ili streptomicin)
English: Adverse reactions that are reported only once are listed as common because a single report raises the frequency above 1%.
Croatian: Nuspojave prijavljene samo jednom navedene su kao česte jer jedna prijava povisi učestalost iznad 1%.
English: • have any other medical conditions (for example, diabetes, heart disease, or any other long-term disease).
Croatian: • ako imate neka druga zdravstvena stanja (na primjer, šećernu bolest, srčanu bolest ili neku drugu dugotrajnu bolest).
English: Small differences in the carbohydrate chain structure are known to exist.
Croatian: Poznato je da postoje male razlike u strukturi lanca ugljikohidrata.
English: Date of first authorisation: 19 March 2009 Date of latest renewal: 21 February 2014
Croatian: Datum posljednje obnove odobrenja: 21. veljače 2014.
English: How are the injections given
Croatian: Kako se daju injekcije
English: Empty cartridges must not be refilled.
Croatian: Prazni ulošci se ne smiju ponovno puniti.
English: Make a note of when you start storing the product out of the refrigerator.
Croatian: Zabilježite kada ste lijek počeli čuvati izvan hladnjaka.
English: A starting dose of 100-225 IU is recommended for at least the first four days.
Croatian: Preporučuje se početna doza od 100-225 IU tijekom najmanje prva četiri dana.
English: If you are troubled by stomach pains, tell your doctor immediately.
Croatian: Ako Vas muče bolovi u trbuhu, odmah obavijestite liječnika.
English: If you are a woman:
Croatian: Ako ste žena:
English: Median total dose (IU)
Croatian: Medijan ukupne doze (IU)
English: Start again with Step 1 using a new syringe, new needles and a new vial of Fertavid.
Croatian: Krenite ponovno od Koraka 1 koristeći novu štrcaljku, nove igle i novu bočicu lijeka Fertavid.
English: • Undiagnosed vaginal bleeding.
Croatian: • Nerazjašnjeno vaginalno krvarenje.
English: There are large differences between women in the response of the ovaries to FSH, which makes it impossible to set a dosage schedule which is suitable for all patients.
Croatian: Postoje velike razlike među ženama u odgovoru jajnika na FSH, zbog čega nije moguće odrediti režim doziranja koji bi bio prikladan za sve bolesnice.
English: Other medicines and Fertavid
Croatian: Drugi lijekovi i Fertavid
English: Late OHSS occurs more than 10 days after hCG administration, as a consequence of the hormonal changes with pregnancy.
Croatian: Kasni OHSS nastaje više od 10 dana nakon primjene hCG-a, kao posljedica hormonskih promjena u trudnoći.
English: If OHSS develops, standard and appropriate management of OHSS should be implemented and followed.
Croatian: Ako se razvije OHSS, potrebno je uvesti i slijediti standardno i odgovarajuće liječenje OHSS-a.
English: If you forget a dose do not use a double dose to make up for a missed dose.
Croatian: Ako ste zaboravili primijeniti dozu, nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: The best site for an injection under the skin is in the lower stomach around the navel (e) where there is a lot of loose skin and layers of fatty tissue.
Croatian: Najbolje mjesto za injekciju pod kožu je donji dio trbuha oko pupka (e), gdje ima dosta labave kože i naslaga masnog tkiva.
English: In repeated-dose studies in rats (two weeks) and dogs (13 weeks) up to 100-fold the maximal human dose, Fertavid 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, Fertavid nije izazvao značajne toksikološke učinke.
English: This is very important since too high a dose of FSH may lead to rare but serious complications in which the ovaries are overly stimulated and the growing follicles become larger than normal.
Croatian: Ovo je vrlo važno jer previsoka doza FSH-a može dovesti do rijetkih ali ozbiljnih komplikacija kada su jajnici pretjerano stimulirani pa rastući folikuli mogu postati veći nego što je normalno.
English: It should be noted, however, that pregnancy itself also carries an increased risk of thrombosis.
Croatian: Međutim, potrebno je istaknuti da sama trudnoća također nosi povećan rizik od tromboze.
English: Additionally for females
Croatian: Dodatno za žene
English: What Fertavid is and what it is used for
Croatian: Što je Fertavid i za što se koristi
English: Your doctor will check the effects of the treatment regularly to be able to choose the correct dose of Fertavid from day to day.
Croatian: Vaš liječnik će redovito provjeravati učinak liječenja kako bi iz dana u dan mogao odabrati pravilnu dozu lijeka Fertavid.
English: You should vary the injection site a little with each injection.
Croatian: Morate mijenjati mjesto injiciranja sa svakom injekcijom.
English: A daily increase of oestradiol levels of 40-100% is considered to be optimal.
Croatian: Optimalnim se smatra dnevni porast razine estradiola od 40-100%.
English: Due to the sustained release from the injection site and the elimination half-life of about 40 hours (ranging from 12 to 70 hours), FSH levels remain increased for 24-48 hours.
Croatian: Zbog postupnog otpuštanja s mjesta injiciranja i poluvremena eliminacije od oko 40 sati (u rasponu od 12 do 70 sati), razine FSH-a ostaju povišene tijekom 24 do 48 sati.
English: If your sperm production has not started after this period, your treatment may carry on for at least 18 months.
Croatian: Ako nakon tog razdoblja nije započelo stvaranje spermija, liječenje se može nastaviti još najmanje 18 mjeseci.
English: Severe OHSS may be life-threatening.
Croatian: Teški OHSS može biti životno opasan.
English: • Malformations of the reproductive organs incompatible with pregnancy.
Croatian: • Malformacije reproduktivnih organa nespojive s trudnoćom.
English: • have adrenal glands that are not working properly (adrenocortical insufficiency)
Croatian: • ako Vam nadbubrežne žlijezde ne rade ispravno (adrenokortikalna insuficijencija)
English: With the other hand, insert the needle at an angle of 90 degrees into the skin's surface, as shown in the picture (f).
Croatian: Drugom rukom ubodite iglu u površinu kože pod kutem od 90°, kako je prikazano na slici (f).
English: This increase enables therapeutic FSH concentrations to be reached.
Croatian: Taj porast omogućava postizanje terapijskih koncentracija FSH-a.
English: Pharmacotherapeutic group: sex hormones and modulators of the genital system, gonadotrophins; ATC code: G03G A06.
Croatian: Farmakoterapijska skupina: spolni hormoni i ostali pripravci koji djeluju na spolni sustav, gonadotropini; ATK oznaka: G03G A06.
English: • are a man and are infertile because of a condition called primary testicular failure.
Croatian: • ako ste muškarac i neplodni ste zbog stanja koje se zove primarno zatajenje testisa.
English: Further details on the treatment schedule are given below.
Croatian: Detalji o režimima liječenja navedeni su u nastavku.
English: If a patient has not responded after this period, the combination therapy may be continued; current clinical experience indicates that treatment for up to 18 months or longer may be necessary to achieve spermatogenesis.
Croatian: Ako bolesnik nakon tog razdoblja nije odgovorio na liječenje, kombinacijsko liječenje se može nastaviti; današnje kliničko iskustvo pokazuje da za postizanje spermatogeneze može biti potrebno do 18 ili više mjeseci liječenja.
English: The risk can be reduced by careful monitoring of follicular development during treatment.
Croatian: Rizik se može smanjiti pažljivim praćenjem razvoja folikula tijekom liječenja.
English: Median duration of treatment (days)
Croatian: Medijan trajanja liječenja (dani)
English: The primary amino acid sequence is identical to that of natural human FSH.
Croatian: Primarni slijed aminokiselina identičan je onom kod prirodnog humanog FSH-a.
English: Clinical use of Fertavid 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 Fertavid intramuskularnim ili supkutanim putem može izazvati lokalne reakcije na mjestu injiciranja (u 3% svih liječenih bolesnika).
English: FSH belongs to the group of gonadotrophins, which play an important role in human fertility and reproduction.
Croatian: FSH pripada skupini gonadotropina, koji su važni za ljudsku plodnost i reprodukciju.
English: Usually, 7 to 14 days of treatment are sufficient.
Croatian: Za to je obično dovoljno 7-14 dana liječenja.
English: Overall experience with IVF indicates that in general the treatment success rate remains stable during the first four attempts and gradually declines thereafter.
Croatian: Sveukupno iskustvo s in vitro oplodnjom ukazuje na to da općenito stopa uspješnosti liječenja ostaje stabilna u prva četiri pokušaja, a da se nakon toga postupno smanjuje.
English: • Primary gonadal failure
Croatian: • Primarno zatajenje gonada.
English: The instructions for using the pen must be followed carefully.
Croatian: Upute za uporabu brizgalice moraju se pažljivo slijediti.
English: What Fertavid looks like and contents of the pack
Croatian: Kako Fertavid izgleda i sadržaj pakiranja
English: When given into a muscle the injection should be given by the doctor or nurse.
Croatian: Ako se injicira u mišić, injekciju mora dati liječnik ili medicinska sestra.
English: If this happens pull out the syringe, cover the injection site with a swab containing disinfectant and apply pressure; the site will stop bleeding in a minute or two.
Croatian: Ako se to dogodi, izvadite štrcaljku i pritisnite mjesto uboda vatom s dezinfekcijskim sredstvom; krvarenje će prestati za 1-2 minute.
English: The volume of the syringe should be small enough so that the prescribed dose can be given with reasonable accuracy.
Croatian: Volumen štrcaljke mora biti dovoljno malen da se propisana doza može precizno odmjeriti.
English: If the number of responding follicles is too high or oestradiol levels increase too rapidly, i.e. more than a daily doubling for oestradiol for two or three consecutive days, the daily dose should be decreased.
Croatian: Ako je broj rastućih folikula prevelik ili razine estradiola rastu prebrzo, tj. više nego dvostruki dnevni porast koncentracija estradiola tijekom 2 ili 3 uzastopna dana, dnevna doza se mora smanjiti.
English: Draw the solution up into the syringe (b), and replace the needle with an injection needle (c).
Croatian: Navucite otopinu u štrcaljku (b) i zamijenite iglu za navlačenje iglom za injekciju (c).
English: If you use more Fertavid than you should
Croatian: Ako primijenite više lijeka Fertavid nego što ste trebali
English: For women having their first cycle of ovarian stimulation, for whom risk factors are only partially known, close observation for early signs and symptoms of OHSS is recommended.
Croatian: U žena koje prolaze prvi ciklus stimulacije jajnika, u kojih su rizični faktori samo djelomično poznati, preporučuje se pažljivo promatranje zbog ranih znakova i simptoma OHSS-a.
English: These antibiotics may cause hypersensitivity reactions in susceptible persons.
Croatian: Ti antibiotici u osjetljivih osoba mogu izazvati reakcije preosjeljivosti.
English: Important information about some of the ingredients of Fertavid
Croatian: Važne informacije o nekim sastojcima lijeka Fertavid
English: Treatment of females:
Croatian: Liječenje žena:
English: Multiple pregnancies carry an increased health risk for both the mother and her babies around the time of birth.
Croatian: Višeplodne trudnoće predstavljaju povećan zdravstveni rizik i za majku i za bebe u vrijeme oko poroda.
English: Clinical experience with Fertavid is based on up to three treatment cycles in both indications.
Croatian: Kliničko iskustvo s lijekom Fertavid u obje se indikacije temelji na do tri ciklusa liječenja.
English: Clean about two inches around the point where the needle will go in and let the disinfectant dry for at least one minute before you proceed.
Croatian: Očistite otprilike 5 cm oko predviđenog mjesta uboda i pustite da se sredstvo suši najmanje jednu minutu prije nego nastavite.
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 Fertavid 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 Fertavid otopina (d).
English: To assess the response, semen analysis is recommended 4 to 6 months after the beginning of treatment.
Croatian: Za ocjenu odgovora na liječenje preporučuje se analiza sjemena 4 do 6 mjeseci nakon početka liječenja.
English: Treatment with Fertavid, just as pregnancy itself, may increase the risk of having a blood clot (thrombosis).
Croatian: Liječenje lijekom Fertavid, baš kao i sama trudnoća, mogu povećati rizik od nastanka krvnog ugruška (tromboze).
English: Local reactions at the site of injection include induration and pain.
Croatian: 2. Lokalne reakcije na mjestu injiciranja uključuju induraciju i bol.
English: Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.
Croatian: Oštećenje jajnika zbog smanjene opskrbe krvlju može se umanjiti ranom dijagnozom i hitnom detorzijom (odvrtanjem).
English: • if you already know you have an increased chance of having thrombosis
Croatian: • ako znate da imate povećan rizik za razvoj tromboze
English: Contact your doctor immediately if you are experiencing stomach pains, also if this occurs some days after the last injection has been given.
Croatian: Odmah se javite svom liječniku ako osjetite bolove u trbuhu, čak i ako se to dogodi nekoliko dana nakon posljednje injekcije.
English: What Fertavid contains
Croatian: Što Fertavid sadrži
English: There are great inter- and intra-individual variations in the response of the ovaries to exogenous gonadotrophins.
Croatian: Postoje velike interindividualne i intraindividualne varijacije u odgovoru jajnika na egzogene gonadotropine.
English: Generalised hypersensitivity reactions have been observed uncommonly (approximately 0.2% of all patients treated with follitropin beta).
Croatian: Generalizirane reakcije preosjetljivosti zabilježene su manje često (u oko 0,2% svih bolesnika liječenih folitropinom beta).
English: Self-administration of Fertavid should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.
Croatian: Fertavid si smiju davati samo bolesnici koji su dobro motivirani, primjereno obučeni i kojima je dostupan stručni savjet.
English: What Fertavid is and what it is used for What you need to know before you use Fertavid How to use Fertavid
Croatian: Što je Fertavid i za što se koristi Što morate znati prije nego počnete primjenjivati Fertavid Kako primjenjivati Fertavid
English: In men, FSH is needed for the production of sperm.
Croatian: U muškaraca je FSH potreban za stvaranje spermija.
English: Generalised hypersensitivity reaction include erythema, urticaria, rash and pruritus
Croatian: Opća reakcija preosjetljivosti uključuje eritem, urtikariju, osip i pruritus
English: • Anovulation
Croatian: • Anovulacija
English: In adult males: • Deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Croatian: U odraslih muškaraca: • Nedostatna spermatogeneza uslijed hipogonadotropnog hipogonadizma.
English: • a lack of blood flow (deep venous thrombosis) that may result in a loss of your arm or leg.
Croatian: • nedostatak protoka krvi (duboka venska tromboza) zbog čega možete izgubiti ruku ili nogu.
English: • if you are severely overweight.
Croatian: • ako imate izrazito povećanu tjelesnu težinu.
English: Kloosterstraat 6, 5349 AB Oss Veersemeer 4, 5347 JN Oss The Netherlands
Croatian: Kloosterstraat 6, 5349 AB Oss Veersemeer 4, 5347 JN Oss Nizozemska
English: • Controlled ovarian hyperstimulation in medically assisted reproduction programs Various stimulation protocols are applied.
Croatian: • Kontrolirana hiperstimulacija jajnika u sklopu postupaka medicinski potpomognute oplodnje Primjenjuju se razni protokoli stimulacije.
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 Fertavid, 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 Fertavid, može dalje povećati taj rizik.
English: If the needle position is correct the plunger should be quite difficult to draw back.
Croatian: Ako je igla u pravilnom položaju, bit će teško povući klip štrcaljke unazad.
English: Intravascular thrombosis, which may originate in venous or arterial vessels, can result in reduced blood flow to vital organs or the extremities.
Croatian: Intravaskularna tromboza, koja može nastati u venskim ili arterijskim žilama, može dovesti do smanjenog dotoka krvi do vitalnih organa ili ekstremiteta.
English: Increased FSH blood levels are a sign of damage to the testicles.
Croatian: Povećane razine FSH-a u krvi su znak oštećenja testisa.
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: Paediatric population There is no relevant use of Fertavid in the paediatric population for the approved indication.
Croatian: Pedijatrijska populacija Nema relevantne primjene lijeka Fertavid u pedijatrijskoj populaciji za odobrenu indikaciju.
English: Storage by the patient
Croatian: Čuvanje kod bolesnika
English: In adult females: Fertavid is indicated for the treatment of female infertility in the following clinical situations:
Croatian: U odraslih žena: Fertavid je indiciran za liječenje ženske neplodnosti u sljedećim kliničkim stanjima:
English: Ectopic Pregnancy
Croatian: Ektopična trudnoća