FrancophonIA/ELRC3.0 huggingface dataset:
English: You should also read the instructions at the end of this leaflet.
Croatian: Trebate pročitati i naputke na kraju ove upute.
English: If you use more Signifor than you should
Croatian: Ako primijenite više Signifora nego što ste trebali
English: Never share needles and syringes.
Croatian: Nikad nemojte dijeliti igle i štrcaljke.
English: If this happens, tell your doctor immediately.
Croatian: Ako se to dogodi, odmah se obratite svom liječniku.
English: The safety and efficacy of Signifor in children and adolescents aged 0 to 18 years have not been established.
Croatian: Sigurnost i djelotvornost Signifora u djece i adolescenata u dobi od 0 do 18 godina nisu ustanovljene.
English: The dose may be decreased either temporarily or permanently.
Croatian: Doza se može smanjiti privremeno ili trajno.
English: This is a long-term treatment, possibly lasting for years.
Croatian: Ovo je dugotrajna terapija, koja može trajati godinama.
English: Normalisation of IGF-1
Croatian: Normalizacija IGF-1
English: - You should not use Signifor during pregnancy unless clearly necessary.
Croatian: - Ne smijete koristiti Signifor tijekom trudnoće osim ako to nije nužno.
English: Also contains:
Croatian: Također sadrži:
English: Ask your doctor about the need for contraception before taking this medicine.
Croatian: Upitajte svog liječnika o potrebi kontracepcije prije nego uzmete ovaj lijek.
English: The improvement observed up to week 24 between the treatment groups was also not statistically significant.
Croatian: Poboljšanja uočena do 24. tjedna između terapijskih skupina također nisu bila statistički značajna.
English: Linearity and time dependency
Croatian: Linearnost i ovisnost o vremenu
English: - If you are a sexually active woman, you should use an effective method of contraception during treatment.
Croatian: - Ako ste spolno aktivna žena, trebate upotrebljavati učinkovitu metodu kontracepcije za vrijeme liječenja.
English: To give yourself an injection you will need:
Croatian: Da biste si dali injekciju treba Vam:
English: Month 6 Month 12
Croatian: 6. mjesec 12. mjesec
English: Similar results were also seen at month 12.
Croatian: Slični rezultati bili su uočeni i u 12. mjesecu.
English: 192 patients were treated.
Croatian: Liječeno je 192 bolesnika.
English: Do not let the needle touch anything.
Croatian: Pazite da igla ništa ne dodiruje.
English: Using Signifor at the same time each day will help you remember when to use your medicine.
Croatian: Primjenjivanje Signifora u isto vrijeme svakoga dana pomoći će Vam da zapamtite kada trebate primijeniti lijek.
English: An audible “click” confirms proper activation.
Croatian: Čut ćete “klik” kao potvrdu pravilne aktivacije.
English: Do not give this medicine to children and adolescents below 18 years old because no data are available in this age group.
Croatian: Nemojte davati ovaj lijek djeci i adolescentima mlađima od 18 godina budući da nema dostupnih podataka za tu dobnu skupinu.
English: The dose may be titrated every 2 to 4 months based on response and tolerability.
Croatian: Doza se može titrirati svakih 2 do 4 mjeseca na temelju odgovora i podnošljivosti.
English: The incidence of such events was highest in the first 3 months of treatment.
Croatian: Incidencija takvih događaja bila je najviša u prva 3 mjeseca liječenja.
English: These reactions resolved spontaneously and required no intervention.
Croatian: Te su se reakcije riješile spontano i nisu zahtijevale intervenciju.
English: Similar trends were observed at month 12.
Croatian: Slični su trendovi bili uočeni u 12. mjesecu.
English: When you are ready to give yourself the injection, carefully follow the steps below: - Wash your hands thoroughly with soap and water.
Croatian: Kada ste spremni dati si injekciju, pažljivo slijedite korake navedene u nastavku: - Temeljito operite ruke sapunom i vodom.
English: Date of first authorisation: 24 April 2012 Date of latest renewal: 18 November 2016
Croatian: Datum posljednje obnove odobrenja: 18. studenog 2016.
English: Long-term follow-up data are not available.
Croatian: Podaci iz dugoročnog praćenja nisu dostupni.
English: Once the ampoule is open, put it upright on a clean, flat surface.
Croatian: Jednom kad je ampula otvorena, stavite ju uspravno na čistu, ravnu površinu.
English: Based on the local clinical practice, your doctor or nurse will tell you which method to use.
Croatian: Ovisno o lokalnoj kliničkoj praksi, Vaš liječnik ili medicinska sestra će Vam reći koju metodu koristiti.
English: Cushing's disease
Croatian: Cushingova bolest
English: During the extension phase, tumour volume continued to decrease.
Croatian: Tijekom faze produžetka volumen tumora nastavio se smanjivati.
English: Alopecia, pruritus
Croatian: Alopecija, pruritus
English: Signifor reduces the production of these hormones and possibly also the size of the adenoma.
Croatian: Signifor smanjuje proizvodnju tih hormona, a moguće i veličinu adenoma.
English: - Inspect the ampoule.
Croatian: - Pregledajte ampulu.
English: The clinical relevance of these effects in humans is unknown.
Croatian: Klinički značaj tih učinaka u ljudi nije poznat.
English: Patients uncontrolled at both month 1 and month 2 are likely (90%) to remain uncontrolled at months 6 and 12.
Croatian: Za bolesnike koji nisu bili kontrolirani u 1. i 2. mjesecu vjerojatno je (90%) da će ostati nekontrolirani u 6. i 12. mjesecu.
English: - Prolonged QT interval (an abnormal electrical signal in your heart that can be seen in tests).
Croatian: - Produženi QT interval (poremećeni električni signal u Vašem srcu koji se može vidjeti na pretragama).
English: Additional dose adjustments (up to a maximum of 40 mg) were allowed at months 7 and 9 of the core phase.
Croatian: Dodatne prilagodbe doze (do najviše 40 mg) bile su dopuštene u 7. i 9. mjesecu osnovne faze.
English: Therefore, do not stop using Signifor unless your doctor tells you to.
Croatian: Stoga nemojte prestati primjenjivati Signifor osim ako Vam to ne kaže liječnik.
English: Your doctor will check regularly how you respond to the treatment with Signifor and determine which dose is best for you.
Croatian: Vaš liječnik će redovito provjeravati kako reagirate na liječenje Signiforom i odrediti koja je doza najbolja za Vas.
English: ATTENTION:
Croatian: OPREZ:
English: These receptor subtypes are expressed in different tissues under normal physiological conditions.
Croatian: Te podvrste receptora izražene su u različitim tkivima u normalnim fiziološkim stanjima.
English: Table 3 Key results at week 24 (Study C2402)
Croatian: Tablica 3 Ključni rezultati u 24. tjednu (ispitivanje C2402)
English: A total of 358 patients were randomised and treated.
Croatian: Ukupno je 358 bolesnika bilo randomizirano i liječeno.
English: - Take the ampoule out of the box.
Croatian: - Izvadite ampulu iz kutije.
English: The study enrolled 150 patients.
Croatian: U ispitivanje je bilo uključeno 150 bolesnika.
English: Hold the syringe in one hand between two fingers with your thumb at the bottom of the plunger.
Croatian: Držite štrcaljku u jednoj ruci između dva prsta, s palcem na dnu klipa.
English: vomiting and low blood pressure.
Croatian: povraćanje i niski krvni tlak.
English: Do not use Signifor - if you are allergic to pasireotide or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Signifor - ako ste alergični na pasireotid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: All QT-related events were transient and resolved without therapeutic intervention.
Croatian: Svi događaji povezani s QT-om bili su prolazni i riješili se bez terapijske intervencije.
English: N=65 n (%), p value
Croatian: N=65 n (%), p vrijednost
English: Depending on the results and how you are feeling, the dose of Signifor given in each injection may need to be reduced or increased.
Croatian: Ovisno o rezultatima i tome kako se osjećate, možda će biti potrebno smanjiti ili povećati dozu Signifora koja se daje u svakoj injekciji.
English: - Low blood pressure.
Croatian: - Niski krvni tlak.
English: This variation is moderate and considered of minor significance considering the wide age range in which the effect was observed.
Croatian: To je odstupanje umjereno i smatra se da je od manje važnosti s obzirom na široki raspon godina u kojem je taj učinak bio uočen.
English: Alcohol wipes or similar
Croatian: Vatice s alkoholom ili slično
English: The clinical significance of this prolongation is unknown.
Croatian: Nije poznat klinički značaj tog produženja.
English: Other medicines and Signifor
Croatian: Drugi lijekovi i Signifor
English: What Signifor is and what it is used for
Croatian: Što je Signifor i za što se koristi
English: A total of 181 patients completed the core phase (24 weeks) of the study.
Croatian: Ukupno je 181 bolesnik dovršio osnovnu fazu (24 tjedna) ispitivanja.
English: Important safety information Caution: Keep the ampoules out of the reach of children.
Croatian: Važne sigurnosne informacije Oprez: Ampule čuvajte izvan dohvata djece.
English: What Signifor is and what it is used for What you need to know before you use Signifor How to use Signifor
Croatian: Što je Signifor i za što se koristi Što morate znati prije nego počnete primjenjivati Signifor Kako primjenjivati Signifor
English: Five human somatostatin receptor subtypes are known: hsst1, 2, 3, 4, and 5.
Croatian: Poznato je pet podvrsta humanih somatostatinskih receptora: hsst1, 2, 3, 4, i 5.
English: Use of the same injection site for two consecutive injections is not recommended.
Croatian: Ne preporučuje se korištenje istog mjesta primjene za dvije uzastopne injekcije.
English: Based on the accumulation ratios of AUC, the calculated effective half-life (t1/2,eff) in healthy volunteers was approximately 12 hours.
Croatian: Na temelju kumulativnih omjera AUC-a, izračunato efektivno poluvrijeme života (t1/2,eff) u zdravih dobrovoljaca bio je približno 12 sati.
English: This may involve measuring the levels of growth hormone or other hormones in your blood.
Croatian: To bi moglo uključivati mjerenje razina hormona rasta ili drugih hormona u Vašoj krvi.
English: In both these cases, return the entire pack to the pharmacy.
Croatian: U oba slučaja, vratite cijelo pakiranje u ljekarnu.
English: Your doctor may wish to monitor your heart rate using a machine that measures electrical activity of the heart (an “ECG”, or electrocardiogram).
Croatian: Liječnik će možda htjeti pratiti Vašu brzinu otkucaja srca korištenjem uređaja koji mjeri električnu aktivnost srca (“EKG”, ili elektrokardiogram).
English: The injection site is the place on your body where you are going to give yourself the injection.
Croatian: Mjesto primjene injekcije je mjesto na Vašem tijelu na kojem si dajete injekciju.
English: Use syringes and needles only once.
Croatian: Upotrijebite štrcaljke i igle samo jednom.
English: If you are using other medicines at the same time as Signifor (including medicines obtained without a prescription), your doctor may need to monitor your heart more carefully or change the dose of Signifor or the other medicines.
Croatian: Ako primjenjujete druge lijekove istodobno kad i Signifor (uključujući lijekove koje ste dobili bez recepta), liječnik će Vam možda morati pažljivije pratiti rad srca ili promijeniti dozu Signifora ili drugih lijekova.
English: In all these cases, return the entire pack to the pharmacy.
Croatian: U takvim slučajevima vratite cijelo pakiranje u ljekarnu.
English: - your doctor may also wish to check your gallbladder, liver enzymes and pituitary hormones periodically, since these might all be affected by this medicine.
Croatian: - Liječnik će možda periodički htjeti provjeriti i Vaš žučni mjehur, jetrene enzime i hormone hipofize, budući da bi ovaj lijek mogao utjecati na sve njih.
English: Tell your doctor straight away if you get any of the following:
Croatian: Odmah se obratite svom liječniku ako primijetite nešto od sljedećeg:
English: Carcinogenicity studies conducted in rats and transgenic mice did not identify any carcinogenic potential.
Croatian: Ispitivanja kancerogenosti povedena na štakorima i transgeničnim miševima nisu utvrdila nikakav kancerogeni potencijal.
English: Doses should not be doubled to make up for a missed dose.
Croatian: Doze se ne smiju udvostručavati da bi se nadoknadila propuštena doza.
English: One long thick blunt sterile needle for drawing up the solution (your doctor or nurse will tell you if this is needed)
Croatian: Jedna dugačka debela tupa sterilna igla za izvlačenje otopine (Vaš liječnik ili medicinska sestra će Vam reći je li ona potrebna)
English: Embryo toxicity was seen in rats and rabbits at doses that caused maternal toxicity but no teratogenic potential was detected.
Croatian: Toksičnost za embrije bila je uočena u štakora i zečeva pri dozama koje su uzrokovale maternalnu toksičnost, ali nije bio uočen teratogeni potencijal.
English: The reconstituted Signifor is now ready for immediate administration.
Croatian: Rekonstituirani Signifor sada je spreman da se odmah primijeni.
English: If you see blood in the syringe, first remove the needle from the skin, then replace the short needle with a new one and insert it into a different injection site.
Croatian: Ako vidite krv u štrcaljki, prvo izvucite iglu iz kože, zatim zamijenite kratku iglu novom i ubodite je u drugo mjesto primjene.
English: Keep the plunger pressed down and hold the syringe in place for 5 seconds.
Croatian: Držite klip pritisnut i štrcaljku na mjestu 5 sekundi.
English: Extension phase
Croatian: Faza produžetka
English: Signifor may affect the way some other medicines work.
Croatian: Signifor bi mogao utjecati na način na koji djeluju neki lijekovi.
English: Multipack containing 3 intermediate cartons
Croatian: Višestruko pakiranje koje sadrži 3 međupakiranja
English: In healthy volunteers, pasireotide is predominantly found in unchanged form in plasma, urine and faeces.
Croatian: U zdravih dobrovoljaca pasireotid se uglavnom nalazi u nepromijenjenom obliku u plazmi, mokraći i stolici.
English: If you are pregnant or think that you may be, it is important to tell your doctor who will discuss with you whether you can use Signifor during your pregnancy.
Croatian: Ako ste trudni ili mislite da biste mogli biti trudni, važno je da se obratite svom liječniku koji će raspraviti s Vama možete li primjenjivati Signifor tijekom trudnoće.
English: Check the expiry date which is stated on the ampoule label (after “EXP”) and check that the ampoule contains the dose that your doctor has prescribed.
Croatian: Provjerite rok valjanosti koji je naveden na naljepnici na ampuli (iza “EXP”) i provjerite da ampula sadrži dozu koju Vam je propisao liječnik.
English: Effect on female fertility
Croatian: Učinak na plodnost u žena
English: Plasma protein binding is moderate (88%) and independent of concentration.
Croatian: Vezanje na proteine plazme je umjereno (88%) i ne ovisi o koncentraciji.
English: • The injection kit must reach room temperature.
Croatian: • Set za primjenu injekcije mora dosegnuti sobnu temperaturu.
English: Distribution between blood cells and plasma is concentration independent and shows that pasireotide is primarily located in the plasma (91%).
Croatian: Distribucija između krvnih stanica i plazme ovisi o koncentraciji i pokazuje da je pasireotid u prvom redu smješten u plazmi (91%).
English: The 60 mg strength is only to be used in the treatment of acromegaly.
Croatian: Jačina od 60 mg koristi se samo u liječenju akromegalije.
English: Your treatment with Signifor should continue for as long as your doctor tells you that it is necessary.
Croatian: Vaša terapija Signiforom treba se nastaviti dokle god Vam liječnik kaže da je to potrebno.
English: All analyses were conducted based on the randomised dose groups.
Croatian: Sve su analize bile provedene na temelju randomiziranih doznih skupina.
English: However, before using the ampoule, please read the following information carefully.
Croatian: Međutim, prije nego što primijenite ampulu, pažljivo pročitajte informacije u nastavku.
English: If not used within 24 hours, the injection kit can be returned to the fridge.
Croatian: Ako se ne upotrijebi u roku od 24 sata, set za primjenu injekcije može se vratiti u hladnjak.
English: Gallbladder and related events
Croatian: Žučni mjehur i povezani događaji
English: Active control N=68 n (%)
Croatian: Aktivna kontrola N=68 n (%)
English: What you need to know before you use Signifor
Croatian: Što morate znati prije nego počnete primjenjivati Signifor
English: * Grouped terms: Adrenal insufficiency includes adrenal insufficiency and blood cortisol decreased.
Croatian: * Objedinjeni izrazi: adrenalna insuficijencija uključuje adrenalnu insuficijenciju i sniženje kortizola u krvi.
English: Other side effects of Signifor may include:
Croatian: Ostale nuspojave Signifora mogu uključivati:
English: ATTENTION: It is essential to start the reconstitution process only after the injection kit reaches room temperature.
Croatian: OPREZ: Nužno je da započnete proces rekonstitucije tek nakon što je set za primjenu injekcije dosegnuo sobnu temperaturu.
English: Pasireotide did not affect insulin sensitivity.
Croatian: Pasireotid nije utjecao na osjetljivost na inzulin.
English: Elderly patients (≥65 years) Age is not a significant covariate in the population pharmacokinetic analysis of patients.
Croatian: Stariji bolesnici (≥65 godina) Dob nije značajna kovarijabla u farmakokinetičkoj analizi populacije bolesnika.
English: Patients who have not responded to Signifor after two months of treatment should be considered for discontinuation.
Croatian: Kod bolesnika koji nisu odgovorili na Signifor nakon dva mjeseca liječenja treba razmisliti o prekidu primjene.
English: - with hypokalaemia and/or hypomagnesaemia.
Croatian: - s hipokalijemijom i/ili hipomagnezemijom.
English: If you have been told to use two needles, you should now replace the long needle with the short one.
Croatian: Ako Vam je rečeno da koristite dvije igle, sada trebate zamijeniti dugačku iglu s kratkom.
English: Insert the needle fully into the left or right gluteus at a 90° angle to the skin.
Croatian: Ubodite iglu do kraja u lijevi ili desni gluteus pod kutem od 90° u odnosu na kožu.
English: If response was not achieved at month 6 or if the response was not maintained during the open-label treatment period, dosage could be increased by 0.3 mg twice daily.
Croatian: Ako odgovor nije bio postignut u 6. mjesecu ili ako odgovor nije bio održan tijekom razdoblja otvorenog liječenja, doza se mogla povećati za 0,3 mg dvaput na dan.
English: It is used to treat acromegaly in adult patients.
Croatian: Primjenjuje se za liječenje akromegalije u odraslih bolesnika.
English: The site of repeat intramuscular injections should be alternated between the left and right gluteal muscle.
Croatian: Mjesto uboda svake sljedeće intramuskularne injekcije treba izmjenjivati između lijevog i desnog glutealnog mišića.
English: The human body naturally produces a substance called somatostatin, which blocks the production of certain hormones, including ACTH.
Croatian: Ljudsko tijelo prirodno proizvodi tvar koja se zove somatostatin, koja blokira proizvodnju određenih hormona, uključujući ACTH.
English: Overall reductions in these parameters tended to be greater in patients that were mUFC responders.
Croatian: Ukupna smanjenja tih parametara obično su bila veća u bolesnika koji su imali odgovor mUFC-a.
English: If you are not sure about giving yourself the injection or if you have any questions, please ask your doctor or nurse for help.
Croatian: Ako niste sigurni oko toga da sami sebi dajete injekciju ili ako imate ikakvih pitanja, zamolite svog liječnika ili medicinsku sestru za pomoć.
English: - Store in a refrigerator (2°C-8°C).
Croatian: - Čuvati u hladnjaku (2°C-8°C).
English: At the end of the core phase, patients not adequately responding to their initial therapy were allowed to switch treatment.
Croatian: Na kraju osnovne faze bolesnici koji nisu odgovarajuće odgovorili na početnu terapiju smjeli su promijeniti terapiju.
English: Do not inject a double dose of Signifor to make up for a forgotten dose.
Croatian: Nemojte ubrizgati dvostruku dozu Signifora kako biste nadoknadili zaboravljenu dozu.
English: Signifor should not be used in patients with severe hepatic impairment (Child Pugh C) (see sections 4.3 and 4.4).
Croatian: Signifor se ne smije koristiti u bolesnika s teškim oštećenjem jetre (Child Pugh C) (vidjeti dijelove 4.3 i 4.4).
English: This medicine comes in an ampoule, i.e. a small glass container.
Croatian: Ovaj lijek isporučuje se u ampuli, tj. malom staklenom spremniku.
English: Signifor 40 mg and Signifor 60 mg are also available in multipacks containing 3 intermediate packs.
Croatian: Signifor 40 mg i Signifor 60 mg su također dostupni u višestrukim pakiranjima koja sadrže 3 međupakiranja.
English: Data on Cushing's disease patients older than 65 years are limited but do not suggest any clinically significant differences in safety and efficacy in relation to younger patients.
Croatian: Podaci o bolesnicima s Cushingovom bolešću starijima od 65 godina ograničeni su, ali ne upućuju na bilo kakve značajne razlike u sigurnosti i djelotvornosti u odnosu na mlađe bolesnike.
English: Each ampoule is packed in a cardboard tray which is placed in an outer box.
Croatian: Svaka ampula pakirana je u kartonsku posudicu koja se nalazi u vanjskoj kutiji.
English: Talk to your doctor before using Signifor if you currently have or have ever had: - problems with your blood sugar levels, whether too high (as in diabetes) or too low
Croatian: Obratite se svom liječniku prije nego primijenite Signifor ako trenutno imate ili ste nekad imali: - probleme s razinama šećera u krvi, bilo previsokim (kao kod šećerne bolesti) ili preniskim
English: These reactions were usually of low grade, required no intervention and improved with continued treatment.
Croatian: Te su reakcije obično bile niskog stupnja, nisu zahtijevale intervenciju i poboljšale su se s nastavkom liječenja.
English: Results are the meanSEM of IC50 values expressed as nmol/l.
Croatian: Rezultati su srednja vrijednostSEM (engl. standard error of mean) vrijednosti IC50 izraženi kao nmol/l.
English: The injection can be prepared using either two different needles to draw up and inject the solution or one short fine injection needle for both steps.
Croatian: Injekcija se može pripremiti ili korištenjem dviju različitih igala za izvlačenje i ubrizgavanje otopine ili korištenjem jedne kratke tanke injekcijske igle za oba koraka.
English: For a range of 60-100 kg the reduction in AUCss with increasing weight is predicted to be approximately 27%, which is considered moderate and of minor clinical significance.
Croatian: Predviđa se da je za raspon od 60-100 kg smanjenje u AUCss s većom težinom približno 27%, što se smatra umjerenim i od malog kliničkog značaja.
English: - Slow heart beat.
Croatian: - Usporeni otkucaji srca.
English: These episodes were sporadic and of single occurrence with no clinical consequence observed.
Croatian: Te su epizode bile sporadične i jednokratne bez uočenih kliničkih posljedica.
English: - Use new disposable needles and syringes every time you give yourself an injection.
Croatian: - Upotrijebite nove štrcaljke i igle za jednokratnu uporabu svaki put kad si dajete injekciju.
English: Repeat moderate shaking for another 30 seconds if the powder is not completely suspended.
Croatian: Ponovno umjereno tresite još 30 sekundi ako se prašak nije u potpunosti suspendirao.
English: There are two critical steps in the reconstitution of Signifor.
Croatian: Dva su ključna koraka u rekonstituciji Signifora.
English: Pasireotide was not genotoxic in in vitro and in vivo assays.
Croatian: Pasireotid nije bio genotoksičan u in vitro i in vivo testovima.
English: Withdraw the needle from the injection site and activate the safety guard (as shown in Step 8).
Croatian: Izvucite iglu s mjesta primjene i aktivirajte štitnik (kako je prikazano u 8. koraku).