FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant administration of pasireotide and ciclosporin may require adjustment of the ciclosporin dose to maintain therapeutic levels.
Croatian: Istodobna primjena pasireotida i ciklosporina mogla bi zahtijevati prilagođavanje doze ciklosporina kako bi se održale terapijske razine.
English: As a result, it reduces the symptoms of acromegaly, which include headache, increased sweating, numbness of the hands and feet, tiredness and joint pain.
Croatian: Kao rezultat toga smanjuje simptome akromegalije, koji uključuju glavobolju, pojačano znojenje, utrnulost šaka i stopala, umor i bol u zglobovima.
English: If such a switch should be required, it is recommended to maintain an interval of at least 28 days between the last intramuscular injection and the first subcutaneous injection, and to initiate the subcutaneous injections at a dose of 0.6 mg pasireotide twice a day.
Croatian: Ako je takav prelazak potreban, preporučuje se zadržati interval od barem 28 dana između zadnje intramuskularne injekcije i prve supkutane injekcije te započeti sa supkutanom injekcijom u dozi od 0,6 mg pasireotida dvaput na dan.
English: If you forget to use Signifor
Croatian: Ako ste zaboravili primijeniti Signifor
English: The coloured dot on the top part marks the position of the breaking point on the neck of the ampoule.
Croatian: Obojana točka na gornjem dijelu označava mjesto loma na vratu ampule.
English: Abdominal distension, vomiting
Croatian: Abdominalna distenzija, povraćanje
English: Slowly release the skin fold and gently pull the needle out.
Croatian: Polako otpustite kožu i lagano izvucite iglu.
English: Pancreatitis is a potential adverse reaction associated with the use of somatostatin analogues due to the association between cholelithiasis and acute pancreatitis.
Croatian: Pankreatitis je potencijalna nuspojava povezana s uporabom analoga somatostatina zbog povezanosti između kolelitijaze i akutnog pankreatitisa.
English: Like the natural peptide hormones somatostatin-14 and somatostatin-28 (also known as somatotropin release inhibiting factor [SRIF]) and other somatostatin analogues, pasireotide exerts its pharmacological activity via binding to somatostatin receptors.
Croatian: Poput prirodnih peptidnih hormona somatostatina-14 i somatostatina-28 (poznatih i kao faktor koji inhibira otpuštanje somatotropina [engl. somatotropin release inhibiting factor, SRIF]) i drugih analoga somatostatina, pasireotid vrši svoju farmakološku aktivnost putem vezivanja za somatostatinske receptore.
English: The unbound plasma pasireotide exposure (AUCinf,u) was increased in subjects with renal impairment (mild: 33%; moderate: 25%, severe: 99%, ESRD: 143%) compared to control subjects.
Croatian: Izloženost nevezanom pasireotidu u plazmi (AUCinf,u) bila je povećana u ispitanika s bubrežnim oštećenjem (blago: 33%, umjereno: 25%, teško: 99%, ESRD: 143%) u odnosu na kontrolne ispitanike.
English: A total of 198 patients were randomised to receive pasireotide intramuscular use 40 mg (n=65), pasireotide intramuscular use 60 mg (n=65) or active control (n=68).
Croatian: Ukupno je 198 bolesnika bilo randomizirano na primanje pasireotida 40 mg intramuskularno (n=65), pasireotida 60 mg intramuskularno (n=65) ili aktivne kontrole (n=68).
English: INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Croatian: MEĐUPAKIRANJE U VIŠESTRUKOM PAKIRANJU (BEZ PLAVOG OKVIRA)
English: Thereafter liver function should be monitored as clinically indicated.
Croatian: Nakon toga jetrenu funkciju treba pratiti prema kliničkim indikacijama.
English: Pasireotide demonstrates low clearance (CL/F ~7.6 litres/h for healthy volunteers and ~3.8 litres/h for Cushing's disease patients).
Croatian: Pasireotid pokazuje niski klirens (CL/F ~7,6 litara/h za zdrave dobrovoljce i ~3,8 litara/h za bolesnike s Cushingovom bolešću).
English: Cardiovascular related events
Croatian: Događaji povezani s kardiovaskularnim sustavom
English: Ampoules should be opened just prior to administration, and any unused portion discarded.
Croatian: Ampule treba otvoriti netom prije primjene, a neiskorišteni dio lijeka potrebno je baciti.
English: Paediatric population No studies have been performed in paediatric patients.
Croatian: Pedijatrijska populacija Nisu provedena ispitivanja na pedijatrijskim bolesnicima.
English: If you interrupt your treatment with Signifor your symptoms may come back.
Croatian: Ako prekinete liječenje Signiforom, simptomi bi Vam se mogli vratiti.
English: The patient should be evaluated for clinical benefit after the first month of treatment and periodically thereafter.
Croatian: Potrebno je procijeniti kliničku korist za bolesnika nakon prvog mjeseca liječenja te periodički nakon toga.
English: • beta blockers (metoprolol, carteolol, propranolol, sotalol)
Croatian: • beta blokatori (metoprolol, karteolol, propranolol, sotalol),
English: In Cushing's disease, the safety assessment of the intramuscular formulation was made based on 150 patients who received pasireotide in the phase III study G2304 (median duration of exposure: 57 weeks).
Croatian: Kod Cushingove bolesti je sigurnost intramuskularne formulacije procijenjena na temelju 150 bolesnika koji su primali pasireotid u ispitivanju G2304 faze III (medijan trajanja izloženosti: 57 tjedana).
English: CARTON OF UNIT PACK
Croatian: KARTONSKA KUTIJA JEDINIČNOG PAKIRANJA
English: This means that it is injected through a short needle into the fatty tissue just under the skin.
Croatian: To znači da se ubrizgava kroz kratku iglu u masno tkivo odmah ispod kože.
English: The reactions were most frequently reported as local pain, erythema, haematoma, haemorrhage and pruritus.
Croatian: Reakcije su najčešće bile prijavljene kao lokalna bol, eritem, hematom, krvarenje i pruritus.
English: Store Signifor ampoules according to the storage conditions listed on the box.
Croatian: Ampule Signifora čuvajte u skladu s uvjetima čuvanja koji su navedeni na kutiji.
English: prolongation (see section 4.5).
Croatian: (vidjeti dio 4.5).
English: To reduce local discomfort, it is recommended that the solution is at room temperature before administration.
Croatian: Da bi se smanjila lokalna nelagoda preporučuje se da otopina bude na sobnoj temperaturi prije primjene.
English: Non-clinical safety data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Croatian: Neklinički podaci o sigurnosti primjene ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala, reproduktivne i razvojne toksičnosti.
English: Three-quarters of patients had previously been treated with octreotide intramuscular use and a quarter with lanreotide deep subcutaneous injection.
Croatian: Tri četvrtine bolesnika prethodno je bilo liječeno oktreotidom primijenjenim intramuskularno, a četvrtina lanreotidom putem duboke supkutane injekcije.
English: Signifor is thus able to block the production of ACTH, helping to control the over-production of cortisol and improve the symptoms of Cushing's disease.
Croatian: Signifor tako može blokirati proizvodnju ACTH-a, pomažući time u kontroli pretjerane proizvodnje kortizola, te poboljšati simptome Cushingove bolesti.
English: Population PK analyses of pasireotide intramuscular use suggest that race does not influence PK parameters.
Croatian: PK analize populacije za pasireotid primijenjen intramuskularno upućuju da rasa ne utječe na PK parametre.
English: Pharmacokinetic steady state for pasireotide intramuscular use is achieved after three months.
Croatian: Farmakokinetičko stanje ravnoteže za pasireotid primijenjen intramuskularno postiže se nakon tri mjeseca.
English: During the extension phase, 74 patients continued receiving pasireotide intramuscular use and 46 patients continued with octreotide intramuscular use treatment.
Croatian: Tijekom faze produžetka, 74 bolesnika nastavilo je primati pasireotid intramuskularno, a 46 bolesnika nastavilo je liječenje oktreotidom intramuskularno.
English: You may experience dizziness, light headedness and dizziness or fainting on standing up.
Croatian: Možete osjetiti omaglicu, ošamućenost i omaglicu ili nesvjesticu kada ustajete.
English: Baseline demographics were well balanced between the two randomised dose groups and consistent with the epidemiology of the disease.
Croatian: Demografske karakteristike na početku bile su dobro uravnotežene između dviju skupina randomiziranih po dozama i u skladu s epidemiologijom bolesti.
English: Changes for the octreotide intramuscular use or lanreotide deep subcutaneous injection group were not statistically significant.
Croatian: Promjene za skupinu koja je primala oktreotid intramuskularno ili onu koja je primala lanreotid dubokom supkutanom injekcijom nisu bile statistički značajne.
English: Patients had to be treated with maximum indicated doses of octreotide intramuscular use (30 mg) or lanreotide deep subcutaneous injection (120 mg) for at least 6 months prior to randomisation.
Croatian: Bolesnici su se morali liječiti najvišim indiciranim dozama oktreotida primijenjenog intramuskularno (30 mg) ili lanreotida primijenjenog dubokom supkutanom injekcijom (120 mg) najmanje 6 mjeseci prije randomizacije.
English: The therapeutic benefits of a reduction or normalisation of serum cortisol levels in female patients with Cushing's disease could potentially restore fertility.
Croatian: Terapijske koristi smanjenja ili normalizacije razina kortizola u serumu u bolesnica s Cushingovom bolešću mogle bi potencijalno obnoviti plodnost.
English: Switch from intramuscular to subcutaneous formulation
Croatian: Prelazak s intramuskularne na supkutanu formulaciju
English: Data on the use of Signifor in patients older than 65 years are limited, but there is no evidence to suggest that dose adjustment is required in these patients (see section 5.2).
Croatian: Podaci o primjeni Signifora u bolesnika starijih od 65 godina su ograničeni, ali nema dokaza koji bi upućivali na to da je za te bolesnike potrebno prilagođavanje doze (vidjeti dio 5.2).
English: IGF-1 mean values at baseline were 2.6, 2.8 and 2.9 x ULN, respectively.
Croatian: Srednje vrijednosti IGF-1 na početku bile su 2,6, 2,8 odnosno 2,9 x GGN.
English: FPG/HbA1c monitoring during treatment should follow established guidelines.
Croatian: Praćenje FPG/HbA1c tijekom liječenja treba se obavljati prema utvrđenim smjernicama.
English: Reductions in serum cortisol and plasma ACTH levels were also observed at month 7 and 12 for each dose group.
Croatian: Smanjenja razina kortizola u serumu i ACTH-a u plazmi također su opažena u 7. i 12. mjesecu za svaku od doznih skupina.
English: A dose increase to 0.9 mg may be considered based on the response to the treatment, as long as the 0.6 mg dose is well tolerated by the patient.
Croatian: Može se razmotriti povećanje doze na 0,9 mg na temelju odgovora na liječenje, pod uvjetom da bolesnik dobro podnosi dozu od 0,6 mg.
English: The frequency and severity of adverse reactions tended to be higher with the higher starting dose of 30 mg, but this was not consistent for all adverse reactions.
Croatian: Učestalost i težina nuspojava obično su bile veće uz višu početnu dozu od 30 mg, ali to nije bio slučaj sa svim nuspojavama.
English: The overall incidence of hyperglycaemia-related adverse reactions was 75.3% (all grades) and 22.7% (CTC Grade 3).
Croatian: Ukupna incidencija nuspojava povezanih s hiperglikemijom bila je 75,3% (svi stupnjevi), odnosno 22,7% (CTC stupanj 3).
English: The degree and frequency of hyperglycaemia observed in the two pivotal studies in acromegaly patients were higher with Signifor intramuscular use than with active control (octreotide intramuscular use or lanreotide deep subcutaneous injection).
Croatian: Stupanj i učestalost hiperglikemije uočeni u dva ključna ispitivanja na bolesnicima s akromegalijom bili su viši uz Signifor primijenjen intramuskularno nego uz aktivnu kontrolu (oktreotid primijenjen intramuskularno ili duboka supkutana injekcija lanreotida).
English: Patients with significantly increased prothrombin time (PT) and partial thromboplastin time (PTT) values or patients receiving coumarin-derivative or heparin-derivative anticoagulants were excluded from clinical studies with pasireotide as the safety of the combination with such anticoagulants has not been established.
Croatian: Bolesnici sa značajno povećanim vrijednostima protrombinskog vremena (PT) i djelomičnog tromboplastinskog vremena (PTT) ili bolesnici koji su primali antikoagulanse koji su derivati kumarina ili heparina bili su isključeni iz kliničkih ispitivanja s pasireotidom zato što sigurnost kombinacije s takvim antikoagulansima nije utvrđena.
English: In acromegaly, the safety assessment was made based on 491 patients who received pasireotide (419 patients received pasireotide intramuscular use and 72 received pasireotide subcutaneous use) in phase I, II and III studies.
Croatian: Kod akromegalije je sigurnost procijenjena na temelju 491 bolesnika koji su primali pasireotid (419 bolesnika primalo je pasireotid intramuskularno, a 72 je primalo pasireotid supkutano) u ispitivanjima faze I, II i III.
English: Reductions in plasma ACTH levels were also observed at each time point for each dose group.
Croatian: Smanjenja u razinama ACTH-a u plazmi bila su uočena i u svakoj vremenskoj točki za svaku doznu skupinu.
English: The control may be too strong and you may experience signs or symptoms associated with a lack of cortisol, such as extreme weakness, tiredness, weight loss, nausea, vomiting or low blood pressure.
Croatian: Ta bi kontrola mogla biti presnažna i mogli biste osjetiti znakove ili simptome povezane s nedostatkom kortizola, kao što su izražena slabost, umor, gubitak težine, mučnina, povraćanje ili niski tlak.
English: This leads the body to over-produce a hormone called adrenocorticotropic hormone (ACTH), which in turn results in over-production of another hormone called cortisol.
Croatian: Zbog toga tijelo proizvodi previše hormona koji se naziva adrenokortikotropni hormon (ACTH), što pak rezultira pretjeranom proizvodnjom drugog hormona koji se zove kortizol.
English: If you are using medicine to treat a heart condition, your doctor may also need to adjust its dosage.
Croatian: Ako uzimate lijek za liječenje srca, liječnik će možda trebati prilagoditi njegovu dozu.
English: In patients who developed hyperglycaemia, the condition generally appeared to respond to antidiabetic therapy.
Croatian: U bolesnika u kojih se razvila hiperglikemija, čini se da je stanje općenito odgovaralo na antidijabetičku terapiju.
English: At month 25, 48.6% of patients (36/74) in the pasireotide intramuscular use group and 45.7% (21/46) in the octreotide intramuscular use group achieved biochemical control.
Croatian: U 25. mjesecu, 48,6% bolesnika (36/74) u skupini koja je primala pasireotid intramuskularno i 45,7% (21/46) u skupini koja je primala oktreotid intramuskularno postiglo je biokemijsku kontrolu.
English: Renal clearance has a minor contribution to the elimination of pasireotide in humans.
Croatian: Bubrežni klirens malo doprinosi eliminaciji pasireotida u ljudi.
English: Gastrointestinal disorders were frequently reported with Signifor.
Croatian: Poremećaji probavnog sustava su često prijavljivani sa Signiforom.
English: If a dose of Signifor is missed the missed injection should be administered as soon as possible.
Croatian: Ako se propusti doza Signifora, propuštenu injekciju potrebno je što prije primijeniti.
English: A total of 201 Cushing's disease patients received Signifor in phase II and III studies.
Croatian: Ukupno 201 bolesnik s Cushingovom bolešću primao je Signifor u ispitivanjima faze II i III.
English: If side effects occur your doctor may temporarily reduce your dose by 0.3 mg per injection.
Croatian: Ako dođe do nuspojava, liječnik Vam može privremeno smanjiti dozu za 0,3 mg po injekciji.
English: Population pharmacokinetic analysis suggests that based on Cmax and AUC, 90% of steady state in Cushing's disease patients is reached after approximately 1.5 and 15 days, respectively.
Croatian: Farmakokinetička analiza populacije upućuje da se na temelju Cmax i AUC-a kod 90% bolesnika s Cushingovom bolešću stanje dinamičke ravnoteže postiže nakon otprilike 1,5 odnosno 15 dana.
English: DO NOT USE if it is broken or if the liquid looks cloudy or contains particles.
Croatian: NE KORISTITE ju ako je razbijena ili ako tekućina izgleda zamućeno ili sadrži čestice.
English: Type 2 diabetes mellitus, glucose tolerance impaired, decreased appetite
Croatian: Šećerna bolest tipa 2, poremećena tolerancija glukoze, smanjeni apetit
English: Preferred injection sites for subcutaneous injections are the top of the thighs and the abdomen (excluding the navel or waistline).
Croatian: Najbolja mjesta za davanje supkutanih injekcija su prednji dio bedara i trbuh (isključujući područje pupka i struka).
English: Facial rubor improved in 43.5% (47/108) of patients, and more than a third of patients demonstrated improvement in supraclavicular fat pad (34.3%) and dorsal fat pad (34.6%).
Croatian: Crvenilo lica poboljšalo se u 43,5% (47/108) bolesnika, a više od trećine bolesnika imalo je poboljšanje u masnom tkivu iznad ključne kosti (34,3%) i dorzalnom masnom tkivu (34,6%).
English: Pasireotide 0.9 mg twice daily % change (n)
Croatian: Pasireotid 0,9 mg dvaput na dan % promjene (n)
English: In clinical studies in Cushing's disease patients, QTcF of >500 msec was observed in two out of 201 patients.
Croatian: U kliničkim ispitivanjima s bolesnicima oboljelima od Cushingove bolesti bio je uočen QTcF od >500 msec u dva od 201 bolesnika.
English: Patients who experience a significant reduction in urinary free cortisol (UFC) levels should continue to receive Signifor for as long as benefit is derived.
Croatian: Bolesnici kod kojih dođe do značajnog smanjenja u razinama slobodnog kortizola u mokraći (engl. urinary free cortisol, UFC) trebaju nastaviti primati Signifor dokle god od toga imaju koristi.
English: Due to its broad binding profile to somatostatin receptors, pasireotide has the potential to stimulate both hsst2 and hsst5 subtype receptors relevant for inhibition of GH and IGF-1 secretion and therefore to be effective for the treatment of acromegaly.
Croatian: Zbog svog širokog profila vezanja za somatostatinske receptore, pasireotid ima potencijal stimuliranja hsst2 i hsst5 podvrsta receptora koji su važni za inhibiciju izlučivanja GH-a i IGF-1 te bi stoga mogao biti djelotvoran za liječenje akromegalije.
English: In the pre- and postnatal study in rats, pasireotide had no effects on labour and delivery, but caused slight retardation in the development of pinna detachment and reduced body weight of the offspring.
Croatian: U pred- i postnatalnom ispitivanju u štakora, pasireotid nije imao utjecaj na trudove i porođaj, ali je uzrokovao blagu retardaciju u razvoju odvajanja ušne školjke i smanjio tjelesnu težinu potomstva.
English: A supportive efficacy analysis was conducted in which patients were further classified into 3 response categories regardless of up-titration at month 3: Fully controlled (UFC ≤1.0 x ULN), partially controlled (UFC >1.0 x ULN but with a reduction in UFC ≥50% compared to baseline) or uncontrolled (reduction in UFC <50%).
Croatian: Provedena je potporna analiza djelotvornosti u kojoj su bolesnici dalje bili razvrstani u 3 kategorije odgovora bez obzira na povećanje titracije u 3. mjesecu: potpuno kontrolirani (UFC ≤1,0 x GGN), djelomično kontrolirani (UFC >1,0 x GGN, ali sa smanjenjem UFC-a ≥50% u usporedbi s početnom vrijednošću) ili nekontrolirani (smanjenje UFC-a <50%).
English: A sharps container or other rigid closed disposal container
Croatian: Spremnik za oštre predmete ili neki drugi čvrsti, zatvoreni spremnik za otpad
English: It is therefore necessary to monitor and instruct patients on the signs and symptoms associated with hypocortisolism (e.g. weakness, fatigue, anorexia, nausea, vomiting, hypotension, hyperkalaemia, hyponatraemia, hypoglycaemia).
Croatian: Stoga je nužno pratiti bolesnike i uputiti ih u znakove i simptome povezane s hipokortizolizmom (npr. slabost, umor, anoreksija, mučnina, povraćanje, hipotenzija, hiperkalijemija, hiponatrijemija, hipoglikemija).
English: Signifor may have a minor influence on the ability to drive and use machines.
Croatian: Signifor može imati mali utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: Further decrease in tumour volume was observed at month 12 after crossover for both treatment groups, and was higher in patients who crossed over to pasireotide intramuscular use (-24.7%) than in patients who crossed over to octreotide intramuscular use (-17.9%).
Croatian: Daljnje smanjenje volumena tumora bilo je uočeno u 12. mjesecu nakon ukrižene zamjene za obje terapijske skupine te je bilo više u bolesnika koji su prešli na pasireotid primijenjen intramuskularno (-24,7%) nego u bolesnika koji su prešli na oktreotid primijenjen intramuskularno (-17,9%).
English: Pasireotide intramuscular use n (%) N=176
Croatian: Pasireotid primijenjen intramuskularno n (%) N=176
English: Adverse reactions are listed according to MedDRA primary system organ class.
Croatian: Nuspojave su navedene po primarnom organskom sustavu prema MedDRA-i.
English: Table 5 Key results - phase III study in Cushing's disease patients (intramuscular formulation)
Croatian: Tablica 5 Ključni rezultati - ispitivanje faze III u bolesnika s Cushingovom bolešću (intramuskularna formulacija)
English: Pasireotide 0.6 mg twice daily % change (n)
Croatian: Pasireotid 0,6 mg dvaput na dan % promjene (n)
English: Slowly depress the plunger until the syringe is empty.
Croatian: Polako pritišćite klip dok se štrcaljka ne isprazni.
English: Pasireotide may decrease the relative bioavailability of ciclosporin.
Croatian: Pasireotid bi mogao smanjiti relativnu bioraspoloživost ciklosporina.
English: Female acromegaly patients had a higher exposure of 32% and 51% compared to male patients in studies with medical treatment naïve patients and inadequately controlled patients, respectively; these differences in exposure were not clinically relevant based on efficacy and safety data.
Croatian: Bolesnice s akromegalijom imale su višu izloženost od 32% odnosno 51% u usporedbi s muškim bolesnicima u ispitivanjima s bolesnicima koji nisu ranije primali terapiju lijekovima odnosno s neodgovarajuće kontroliranim bolesnicima; te razlike u izloženosti nisu bile klinički relevantne na temelju podataka o djelotvornosti i sigurnosti.
English: At month 12, reduction in tumour volume was comparable between the treatment groups and in patients with and without previous pituitary surgery.
Croatian: U 12. mjesecu smanjenje u volumenu tumora bilo je usporedivo između terapijskih skupina i u bolesnika s prethodnom operacijom hipofize ili bez nje.
English: The dose may be increased to a maximum of 60 mg for patients whose growth hormone (GH) and/or insulin-like growth factor-1 (IGF-1) levels are not fully controlled after 3 months of treatment with Signifor at 40 mg.
Croatian: Doza se može povisiti na najviše 60 mg za bolesnike čije razine hormona rasta (engl. growth hormone, GH) i/ili inzulinu sličnog faktora rasta-1 (engl. insulin like growth factor 1, IGF-1) nisu u potpunosti pod kontrolom nakon 3 mjeseca liječenja Signiforom u dozi od 40 mg.
English: The patient should be monitored for response and tolerability and further dose adjustments may be needed.
Croatian: Potrebno je u bolesnika pratiti odgovor i podnošljivost te mogu biti potrebne daljnje prilagodbe doze.
English: The adverse reactions in Table 1 include events reported in the pivotal studies with the intramuscular formulation in patients with acromegaly and with Cushing's disease.
Croatian: Nuspojave navedene u Tablici 1 uključuju događaje prijavljene u ključnim ispitivanjima s intramuskularnom formulacijom u bolesnika s akromegalijom i s Cushingovom bolešću.
English: Octreotide intramuscular use n (%) N=182
Croatian: Oktreotid primijenjen intramuskularno n (%) N=182
English: Median change in UFC (% from baseline)
Croatian: Medijan promjene UFC-a (% od početne vrijednosti)