FrancophonIA/ELRC3.0 huggingface dataset:
English: Rapid, complete or near-complete suppression of ACTH may lead to a decrease in circulating levels of cortisol and potentially to transient hypocortisolism/hypoadrenalism.
Croatian: Brza, potpuna ili gotovo potpuna supresija ACTH-a može dovesti do smanjenja u cirkulirajućim razinama kortizola i potencijalno do prolaznog hipokortizolizma/hipoadrenalizma.
English: - You should not breast-feed while using Signifor.
Croatian: - Ne smijete dojiti dok primjenjujete Signifor.
English: Most findings seen in repeated toxicity studies were reversible and attributable to the pharmacology of pasireotide.
Croatian: Većina nalaza uočenih u ponovljenim ispitivanjima toksičnosti bila je reverzibilna i mogla se pripisati farmakologiji pasireotida.
English: Especially, tell your doctor if you are using: - medicines used in organ transplantation to reduce the activity of the immune system
Croatian: Svakako recite liječniku ako uzimate: - lijekove koji se koriste kod presađivanja organa za smanjivanje aktivnosti imunološkog sustava
English: Gently pinch the skin at the injection site and, holding the needle at an angle of approximately 45 degrees (as shown in the picture) insert it into the injection site.
Croatian: Nježno uštipnite kožu na mjestu primjene injekcije i držeći iglu pod kutem od otprilike 45 stupnjeva (kako je prikazano na slici) ubodite ju u kožu.
English: After the initial 6 months in the study, patients entered an additional 6-month open-label treatment period.
Croatian: Nakon početnih 6 mjeseci u ispitivanju, bolesnici su ušli u dodatno 6-mjesečno razdoblje otvorenog liječenja.
English: Patients should be advised to be cautious when driving or using machines if they experience fatigue, dizziness or headache during treatment with Signifor.
Croatian: Bolesnike treba upozoriti da budu oprezni kada upravljaju vozilima ili rade sa strojevima ako osjete umor, omaglicu ili glavobolju tijekom liječenja Signiforom.
English: Rapid decreases in cortisol levels may be associated with decreases in white blood cell count.
Croatian: Brza smanjenja razina kortizola mogu biti povezana sa smanjenjem broja bijelih krvnih stanica.
English: Pasireotide 10 mg N=74
Croatian: Pasireotid 10 mg N=74
English: Table 2 Binding affinities of somatostatin (SRIF-14), pasireotide, octreotide and lanreotide to the five human somatostatin receptor subtypes (hsst1-5)
Croatian: Tablica 2 Afinitet vezanja somatostatina (SRIF-14), pasireotida, oktreotida i lanreotida za pet podvrsta humanog somatostatin receptora (hsst1-5)
English: - Signifor may lower your heart rate.
Croatian: - Signifor bi Vam mogao sniziti brzinu rada srca.
English: Population pharmacokinetic analyses of Signifor suggest that race and gender do not influence pharmacokinetic parameters.
Croatian: Farmakokinetičke analize populacije za Signifor upućuju da rasa i spol ne utječu na farmakokinetičke parametre.
English: Cushing's disease study G2304
Croatian: Ispitivanje u bolesnika s Cushingovom bolešću G2304
English: During the pivotal study, HbA1c levels increased significantly and stabilised but did not return to baseline values (see section 4.8).
Croatian: Za vrijeme ključnog ispitivanja, razine HbA1c značajno su se povisile i stabilizirale, ali se nisu vratile na početne vrijednosti (vidjeti dio 4.8).
English: How long to use Signifor You should continue using Signifor for as long as your doctor tells you to.
Croatian: Koliki dugo primjenjivati Signifor Signifor trebate nastaviti primjenjivati dokle god Vam liječnik to kaže.
English: - If you are breast-feeding, ask your doctor for advice before taking this medicine, as it is not known whether Signifor passes into breast milk.
Croatian: - Ako dojite, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek, jer nije poznato prelazi li Signifor u majčino mlijeko.
English: This medicine will be given to you by a trained healthcare professional.
Croatian: Ovaj lijek će Vam primijeniti educirani zdravstveni radnik.
English: Available toxicological data in animals have shown excretion of pasireotide in milk.
Croatian: Dostupni toksikološki podaci u životinja pokazali su izlučivanje pasireotida u mlijeku.
English: What Signifor contains - The active substance is pasireotide.
Croatian: Što Signifor sadrži - Djelatna tvar je pasireotid.
English: - Signifor may cause your blood sugar to increase.
Croatian: - Signifor bi mogao uzrokovati povećanje šećera u krvi.
English: Pasireotide 30 mg N=76
Croatian: Pasireotid 30 mg N=76
English: The mean age of patients was approximately 40 years and the majority of patients (77.8%) were female.
Croatian: Srednja dob bolesnika bila je otprilike 40 godina, a većina bolesnika (77,8%) bile su žene.
English: You should also avoid injections at sites that are sore or where the skin is irritated.
Croatian: Također trebate izbjegavati injekcije na mjestima koja su bolna ili na kojima je koža nadražena.
English: Make sure there is no air bubble in the syringe by pressing the plunger until the first drop appears on the tip of the needle.
Croatian: Provjerite da nema mjehurića zraka u štrcaljki tako što ćete pritisnuti klip dok se na vrhu igle ne pojavi prva kapljica.
English: Sinus bradycardia includes bradycardia and sinus bradycardia.
Croatian: Sinusna bradikardija uključuje bradikardiju i sinusnu bradikardiju.
English: After a single injection, the plasma pasireotide concentration shows an initial burst release on the injection day, followed by a dip from day 2 to day 7, then a slow increase to maximum concentration around day 21, and a slow declining phase over the next weeks, concomitant with the terminal degradation phase of the polymer matrix of the dosage form.
Croatian: Nakon jednokratne injekcije, koncentracija pasireotida u plazmi pokazuje početno naglo oslobađanje na dan injekcije, nakon čega slijedi pad od 2. do 7. dana, a zatim sporo povećanje do maksimalne koncentracije oko 21. dana te spora faza opadanja tijekom narednih tjedana, istodobno s fazom terminalne degradacije polimernog matriksa farmaceutskog oblika.
English: Adrenal insufficiency*
Croatian: Adrenalna insuficijencija*
English: Treatment should not be restarted if the liver function abnormalities are suspected to be related to pasireotide.
Croatian: Ne smije se ponovno započinjati liječenje ako se sumnja da su abnormalnosti u funkciji jetre povezane s pasireotidom.
English: The dose could be reduced by decrements of 0.3 mg twice daily at any time during the study for reasons of intolerability.
Croatian: Doza se mogla smanjiti za po 0,3 mg dvaput na dan u bilo kojem trenutku tijekom ispitivanja zbog nepodnošljivosti.
English: After you have started treatment, your doctor may reassess your dose.
Croatian: Nakon što ste započeli liječenje, liječnik bi mogao ponovno procijeniti Vašu dozu.
English: To avoid sedimentation, you may gently shake the syringe to maintain a uniform suspension.
Croatian: Da biste izbjegli sedimentaciju možete lagano protresti štrcaljku kako bi suspenzija ostala jednolična.
English: Somatostatin analogues bind to hsst receptors with different potencies (see Table 2).
Croatian: Analozi somatostatina vežu se za hsst receptore različitim snagama (vidjeti Tablicu 2).
English: Before you proceed to step 4, clean the injection site with an alcohol wipe.
Croatian: Prije nego što prijeđete na korak 4, očistite mjesto primjene injekcije tupferom natopljenim alkoholom.
English: Overall reductions in these parameters were observed in patients with full and partial mean UFC control but tended to be greater in patients with normalised UFC.
Croatian: Ukupna smanjenja u tim parametrima bila su uočena u bolesnika s potpunom i djelomičnom kontrolom srednjeg UFC-a, ali obično su bila veća u bolesnika s normaliziranim UFC-om.
English: Signifor suspension must only be prepared immediately before administration.
Croatian: Suspenzija Signifora mora se pripremiti tek neposredno prije primjene.
English: Tap the ampoule with your finger in order to make sure there is no liquid in the top part when you open the ampoule.
Croatian: Lagano kucnite ampulu prstom kako biste osigurali da nema tekućine u gornjem dijelu ampule kada ju otvarate.
English: Not following them could result in failure to deliver the injection appropriately.
Croatian: Ako ih se ne pridržavate, moguće je da nećete moći pravilno primijeniti injekciju.
English: If uncontrolled hyperglycaemia persists despite appropriate medical management, the dose of Signifor should be reduced or Signifor treatment discontinued (see also section 4.5).
Croatian: Ako nekontrolirana hiperglikemija ustraje usprkos odgovarajućem medicinskom zbrinjavanju, treba smanjiti dozu Signifora ili prekinuti liječenje Signiforom (vidjeti također dio 4.5).
English: Breast-feeding should be discontinued during treatment with Signifor.
Croatian: Dojenje treba prekinuti za vrijeme liječenja Signiforom.
English: Two months after the start of Signifor therapy, patients should be evaluated for clinical benefit.
Croatian: Dva mjeseca nakon početka terapije Signiforom kod bolesnika treba procijeniti kliničku korist.
English: The thighs and the abdomen are good areas for subcutaneous injection.
Croatian: Bedra i trbuh su dobra područja za potkožnu injekciju.
English: In the event of overdose, it is recommended that appropriate supportive treatment be initiated, as dictated by the patient's clinical status, until resolution of the symptoms.
Croatian: U slučaju predoziranja, preporučuje se započinjanje odgovarajućeg potpornog liječenja, u skladu s bolesnikovim kliničkim statusom, do povlačenja simptoma.
English: Pregnancy, breast-feeding and fertility Ask your doctor or pharmacist for advice before using any medicine.
Croatian: Trudnoća, dojenje i plodnost Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.
English: The presence of gallstones in Signifor-treated patients is largely asymptomatic; symptomatic stones should be managed according to clinical practice.
Croatian: Prisutnost žučnih kamenaca u bolesnika liječenih Signiforom uglavnom je asimptomatska; simptomatske kamence treba zbrinjavati u skladu s kliničkom praksom.
English: If you forgot to inject a dose of Signifor, simply inject the next dose at the scheduled time.
Croatian: Ako ste zaboravili ubrizgati dozu Signifora, jednostavno ubrizgajte sljedeću dozu u predviđeno vrijeme.
English: You may experience sudden back pain or pain in the right side of your abdomen.
Croatian: Možete osjetiti iznenadnu bol u leđima ili bol na desnoj strani trbuha.
English: * Cholecystitis includes cholecystitis acute
Croatian: *Kolecistitis uključuje akutni kolecistitis
English: The mean age was 35.8 years, and the majority of patients were female (78.8%).
Croatian: Srednja dob bila je 35,8 godina, a većina bolesnika bila je ženskog spola (78,8%).
English: Check the expiry date and the dose
Croatian: Provjerite rok valjanosti i dozu
English: The adenoma leads the body to over-produce hormones that control growth of tissues, organs and bones, resulting in an increase in the size of bones and tissues, especially in the hands and feet.
Croatian: Zbog adenoma tijelo proizvodi previše hormona koji kontroliraju rast tkiva, organa i kostiju, što rezultira povećanjem veličine kostiju i tkiva, osobito u šakama i stopalima.
English: To prepare Signifor for deep intramuscular injection, please adhere to the following instructions:
Croatian: Da biste pripremili Signifor za duboku intramuskularnu injekciju slijedite upute u nastavku:
English: • insulin;
Croatian: • inzulin;
English: Medicinal products that prolong the QT interval
Croatian: Lijekovi koji produžuju QT interval
English: The two treatment groups were well balanced in terms of baseline demographics and disease characteristics.
Croatian: Dvije terapijske skupine bile su dobro uravnotežene u smislu početnih demografskih podataka i karakteristika bolesti.
English: Severe hepatic impairment (Child Pugh C).
Croatian: Teško oštećenje jetre (Child Pugh C).
English: In vitro studies have shown that corticotroph tumour cells from Cushing's disease patients display a high expression of hsst5, whereas the other receptor subtypes either are not expressed or are expressed at lower levels.
Croatian: In vitro ispitivanja pokazala su da kortikotropne tumorske stanice bolesnika s Cushingovom bolešću imaju visoku ekspresiju hsst5, dok druge podvrste receptora ili nisu izražene ili su izražene u manjoj mjeri.
English: Follow the instructions below carefully to ensure proper reconstitution of Signifor powder and solvent for suspension for injection before deep intramuscular injection.
Croatian: Pažljivo slijedite upute u nastavku kako biste osigurali pravilnu rekonstituciju Signifor praška i otapala za suspenziju za injekciju prije duboke intramuskularne injekcije.
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, somatostatin and analogues, ATC code: H01CB05
Croatian: Farmakoterapijska skupina: hipofizni i hipotalamički hormoni i analozi, somatostatin i analozi, ATK oznaka: H01CB05
English: Pasireotide for intramuscular use is formulated as microspheres for long-acting release.
Croatian: Pasireotid za intramuskularnu primjenu formuliran je u obliku mikrosfera za dugotrajno oslobađanje.
English: If you have been told to use two needles, you should use the long thick blunt one for this step.
Croatian: Ako Vam je rečeno da koristite dvije igle, za ovaj korak koristite dugačku debelu tupu iglu.
English: It is particularly important that you mention any of the following medicines: - ciclosporin (used in organ transplantation to reduce the activity of the immune system); - medicines to treat blood sugar levels that are too high (as in diabetes) or too low (hypoglycaemia), such as:
Croatian: Osobito je važno da spomenete ako uzimate bilo koji od sljedećih lijekova: - ciklosporin (koristi se kod presađivanja organa da bi se smanjila aktivnost imunološkog sustava); - lijekove za liječenje razina šećera u krvi koje su previsoke (kao kod šećerne bolesti) ili preniske (hipoglikemija), kao što su:
English: In subjects with moderate and severe hepatic impairment, AUCinf was increased 60% and 79%, Cmax was increased 67% and 69%, and CL/F was decreased 37% and 44%, respectively.
Croatian: U ispitanika s umjerenim i teškim oštećenjem jetre, AUCinf se povećao 60% odnosno 79%, Cmax se povećao 67% odnosno 69%, a CL/F se smanjio 37% odnosno 44%.
English: The median exposure to the treatment up to the cut-off date of the primary efficacy and safety analysis was 10.37 months (0.03-37.8), with 66.0% of patients having at least six months' exposure.
Croatian: Medijan izloženosti liječenju do isključnog datuma za primarnu analizu djelotvornosti i sigurnosti bio je 10,37 mjeseci (0,03-37,8), pri čemu je 66,0% bolesnika bilo izloženo terapiji najmanje šest mjeseci.
English: • cholinesterase inhibitors (rivastigmine, physostigmine); - medicines to control the balance of electrolytes (potassium, magnesium) in your body.
Croatian: • inhibitori kolinesteraze (rivastigmin, fizostigmin), - lijekove za kontroliranje ravnoteže elektrolita (kalija, magnezija) u Vašem tijelu.
English: During your treatment with Signifor: - Signifor may cause your blood sugar to increase.
Croatian: Tijekom liječenja Signiforom - Signifor bi mogao uzrokovati povećanje šećera u krvi.
English: No change in the pharmacokinetics (rate or extent of exposure) of pasireotide was observed.
Croatian: Nije uočena promjena u farmakokinetici (brzini ili opsegu izloženosti) pasireotida.
English: In patients treated with pasireotide intramuscular use in whom reductions in GH and IGF-1 levels were observed, these changes occurred during the first 3 months of treatment and were maintained up to week 24.
Croatian: U bolesnika liječenih pasireotidom primijenjenim intramuskularno u kojih su uočena smanjenja razina GH-a i IGF-1, te su se promjene javile tijekom prva 3 mjeseca liječenja i održale su se do 24. tjedna.
English: If you have liver disease before you start Signifor treatment for acromegaly, your doctor may want to start your treatment with a dose of 20 mg.
Croatian: Ako imate bolest jetre prije nego što započnete liječenje Signiforom za akromegaliju, liječnik će možda htjeti da započnete liječenje dozom od 20 mg.
English: The eligibility criteria included a mean urinary free cortisol (mUFC) value of between 1.5 and 5 times upper limit of normal (ULN) at screening.
Croatian: Kriteriji podobnosti uključivali su srednju vrijednost slobodnog kortizola u urinu (mUFC) između 1,5 i 5 puta gornje granice normale (GGN) na probiru.
English: Myalgia, arthralgia
Croatian: Mijalgija, artralgija
English: If you stop using Signifor
Croatian: Ako prestanete primjenjivati Signifor
English: Frequencies were defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100).
Croatian: Učestalost je definirana na sljedeći način: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100).
English: If no clinical benefit is observed, the patient should be considered for discontinuation.
Croatian: Ukoliko nije opažena klinička korist u bolesnika, potrebno je razmotriti obustavu primjene.
English: At the end of the core phase, patients achieving biochemical control or benefiting from the treatment as assessed by the investigator could continue to be treated in the extension phase with the study treatment to which they were initially randomised.
Croatian: Na kraju osnovne faze, bolesnici koji su postigli biokemijsku kontrolu ili imali koristi od liječenja prema procjeni ispitivača mogli su se nastaviti liječiti u fazi produžetka ispitivanom terapijom na koju su inicijalno bili randomizirani.
English: Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Croatian: Vaše stanje da bi provjerio ima li terapija željeni učinak.
English: Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding.
Croatian: Bolesnike kod kojih se razviju povišene razine transaminaze treba pratiti s drugom procjenom jetrene funkcije kako bi se potvrdio nalaz.
English: The next dose should then be planned for 4 weeks after the injection is administered in order to resume the normal schedule of one dose every 4 weeks.
Croatian: Sljedeću dozu zatim treba planirati za 4 tjedna od primijenjene injekcije kako bi se nastavilo s uobičajenim rasporedom primjene jedne doze svaka 4 tjedna.
English: Injection site reactions were also reported in clinical studies in other populations.
Croatian: Reakcije na mjestu primjene injekcije bile su prijavljene i u kliničkim ispitivanjima na drugim populacijama.
English: Two-thirds of all patients had undergone prior surgery.
Croatian: Dvije trećine svih bolesnika prethodno je bilo podvrgnuto kirurškom zahvatu.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Croatian: Sav neiskorišteni lijek ili otpadni materijal treba ukloniti u skladu s lokalnim propisima.
English: Based on population pharmacokinetic (PK) analyses, the estimated CL/F was approximately 4.8 to 6.5 litres/h for typical Cushing's disease patients, and approximately 5.6 to 8.2 litres/h for typical acromegaly patients.
Croatian: Na temelju farmakokinetičkih (PK) analiza populacije, procijenjeni CL/F bio je približno 4,8 do 6,5 litara/h za tipične bolesnike s Cushingovom bolešću, te približno 5,6 do 8,2 litara/h za tipične bolesnike s akromegalijom.
English: ATTENTION: Keep the plunger pressed and shake the vial moderately for a minimum of 30 seconds so that the powder is completely suspended.
Croatian: OPREZ: Držite klip pritisnut i tresite bočicu umjereno najmanje 30 sekundi kako bi se prašak u potpunosti suspendirao.
English: At month 7, most patients demonstrated either improvement in or stable signs of Cushing's disease such as hirsuitism, striae, bruising and muscle strength.
Croatian: U 7. mjesecu u većine je bolesnika bilo prisutno ili poboljšanje ili stabilizacija znakova Cushingove bolesti kao što su hirzutizam, strije, podljevi i mišićna snaga.
English: Cholecystitis includes cholecystitis acute and cholecystitis chronic.
Croatian: Kolecistitis uključuje akutni kolecistitis i kronični kolecistitis.
English: One short fine sterile needle
Croatian: Jedna kratka tanka sterilna igla
English: In addition, monitoring of FPG 4 weeks and HbA1c 3 months after the end of the treatment should be performed.
Croatian: Nadalje, treba obavljati praćenje FPG-a četiri tjedna, a HbA1c 3 mjeseca nakon završetka liječenja.
English: Monitoring of liver function is recommended prior to treatment with pasireotide and after one, two, four, eight and twelve weeks during treatment.
Croatian: Praćenje jetrene funkcije preporučuje se prije liječenja pasireotidom te nakon jedan, dva, četiri, osam i dvanaest tjedana tijekom liječenja.
English: If you interrupt your treatment with Signifor your cortisol level may increase again and your symptoms may come back.
Croatian: Ako prekinete liječenje Signiforom, razina kortizola mogla bi Vam se ponovo povisiti i simptomi bi se mogli vratiti.
English: Grade 1 and 2 adverse reactions were reported in 57.4% of patients.
Croatian: Nuspojave 1. i 2. stupnja bile su prijavljene kod 57,4% bolesnika.
English: In the phase III studies, injection site related reactions (e.g. injection site pain, injection site discomfort) were mostly grade 1 or 2 in severity.
Croatian: U ispitivanjima faze III, reakcije na mjestu primjene injekcije (npr. bol na mjestu primjene injekcije, nelagoda na mjestu primjene injekcije) bile su po težini uglavnom stupnja 1 ili 2.
English: In the studied age range 18-73 years, the area under the curve at steady state for one dosing interval of 12 hours (AUCss) is predicted to range from 86% to 111% of that of the typical patient of 41 years.
Croatian: U ispitivanom dobnom rasponu od 18-73 godina, predviđa se da će površina ispod krivulje u stanju dinamičke ravnoteže za jedan interval doziranja od 12 sati (AUCss) biti od 86% do 111% površine tipičnog bolesnika starog 41 godinu.
English: Pasireotide should be used with caution and the benefit risk carefully weighed in patients who are at significant risk of developing prolongation of QT, such as those: - with congenital long QT syndrome.
Croatian: Pasireotid treba oprezno koristiti te pažljivo odvagnuti omjer koristi i rizika u bolesnika kod kojih postoji značajan rizik od razvoja produženja QT intervala, kao što su bolesnici: - s prirođenim sindromom dugog QT intervala.
English: Take the sterile syringe and attach the needle to it.
Croatian: Uzmite sterilnu štrcaljku i na nju pričvrstite iglu.
English: This may involve measuring the levels of cortisol in your blood or urine.
Croatian: To bi moglo uključivati mjerenje razina kortizola u Vašoj krvi ili mokraći.
English: • calcium channel blockers (bepridil, verapamil, diltiazem)
Croatian: • blokatori kalcijevih kanala (bepridil, verapamil, diltiazem),
English: In the event of documented hypocortisolism, temporary exogenous steroid (glucocorticoid) replacement therapy and/or dose reduction or interruption of Signifor therapy may be necessary.
Croatian: U slučaju dokumentiranog hipokortizolizma možda će biti potrebna privremena egzogena nadomjesna terapija steroidima (glukokortikoidom) i/ili smanjenje ili prekid uzimanja terapije Signiforom.
English: Patients should receive instructions from the physician or a healthcare professional on how to inject Signifor subcutaneously.
Croatian: Bolesnici trebaju dobiti upute od liječnika ili zdravstvenog radnika za supkutano ubrizgavanje Signifora.
English: The dose should not exceed 40 mg.
Croatian: Doza ne smije premašiti 40 mg.
English: Each ampoule contains 1 ml of solution for injection.
Croatian: Svaka ampula sadrži 1 ml otopine za injekciju.
English: 6 ampoules.
Croatian: 6 ampula.
English: Following multiple monthly doses, pasireotide intramuscular use demonstrates approximately dose-proportional pharmacokinetic exposures in the dose range of 10 mg to 60 mg every 4 weeks.
Croatian: Nakon višestrukih mjesečnih doza, pasireotid primijenjen intramuskularno pokazuje otprilike dozi proporcionalne farmakokinetičke izloženosti u rasponu doze od 10 mg do 60 mg svaka 4 tjedna.
English: The dose should not exceed 60 mg.
Croatian: Doza ne smije premašiti 60 mg.