natgillin/translations-raw huggingface dataset:
To reduce local discomfort, it is recommended that the solution is at room temperature before administration.
Da bi se smanjila lokalna nelagoda preporučuje se da otopina bude na sobnoj temperaturi prije primjene.
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.
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.
Three-quarters of patients had previously been treated with octreotide intramuscular use and a quarter with lanreotide deep subcutaneous injection.
Tri četvrtine bolesnika prethodno je bilo liječeno oktreotidom primijenjenim intramuskularno, a četvrtina lanreotidom putem duboke supkutane injekcije.
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.
Signifor tako može blokirati proizvodnju ACTH-a, pomažući time u kontroli pretjerane proizvodnje kortizola, te poboljšati simptome Cushingove bolesti.
Population PK analyses of pasireotide intramuscular use suggest that race does not influence PK parameters.
PK analize populacije za pasireotid primijenjen intramuskularno upućuju da rasa ne utječe na PK parametre.
Pharmacokinetic steady state for pasireotide intramuscular use is achieved after three months.
Farmakokinetičko stanje ravnoteže za pasireotid primijenjen intramuskularno postiže se nakon tri mjeseca.
During the extension phase, 74 patients continued receiving pasireotide intramuscular use and 46 patients continued with octreotide intramuscular use treatment.
Tijekom faze produžetka, 74 bolesnika nastavilo je primati pasireotid intramuskularno, a 46 bolesnika nastavilo je liječenje oktreotidom intramuskularno.
You may experience dizziness, light headedness and dizziness or fainting on standing up.
Možete osjetiti omaglicu, ošamućenost i omaglicu ili nesvjesticu kada ustajete.
Baseline demographics were well balanced between the two randomised dose groups and consistent with the epidemiology of the disease.
Demografske karakteristike na početku bile su dobro uravnotežene između dviju skupina randomiziranih po dozama i u skladu s epidemiologijom bolesti.
Changes for the octreotide intramuscular use or lanreotide deep subcutaneous injection group were not statistically significant.
Promjene za skupinu koja je primala oktreotid intramuskularno ili onu koja je primala lanreotid dubokom supkutanom injekcijom nisu bile statistički značajne.
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.
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.
The therapeutic benefits of a reduction or normalisation of serum cortisol levels in female patients with Cushing's disease could potentially restore fertility.
Terapijske koristi smanjenja ili normalizacije razina kortizola u serumu u bolesnica s Cushingovom bolešću mogle bi potencijalno obnoviti plodnost.
Switch from intramuscular to subcutaneous formulation
Prelazak s intramuskularne na supkutanu formulaciju
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).
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).
IGF-1 mean values at baseline were 2.6, 2.8 and 2.9 x ULN, respectively.
Srednje vrijednosti IGF-1 na početku bile su 2,6, 2,8 odnosno 2,9 x GGN.
FPG/HbA1c monitoring during treatment should follow established guidelines.
Praćenje FPG/HbA1c tijekom liječenja treba se obavljati prema utvrđenim smjernicama.
Reductions in serum cortisol and plasma ACTH levels were also observed at month 7 and 12 for each dose group.
Smanjenja razina kortizola u serumu i ACTH-a u plazmi također su opažena u 7. i 12. mjesecu za svaku od doznih skupina.
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.
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.
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.
Učestalost i težina nuspojava obično su bile veće uz višu početnu dozu od 30 mg, ali to nije bio slučaj sa svim nuspojavama.
The overall incidence of hyperglycaemia-related adverse reactions was 75.3% (all grades) and 22.7% (CTC Grade 3).
Ukupna incidencija nuspojava povezanih s hiperglikemijom bila je 75,3% (svi stupnjevi), odnosno 22,7% (CTC stupanj 3).
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).
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).
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.
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.
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.
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.
Reductions in plasma ACTH levels were also observed at each time point for each dose group.
Smanjenja u razinama ACTH-a u plazmi bila su uočena i u svakoj vremenskoj točki za svaku doznu skupinu.
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.
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.
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.
Zbog toga tijelo proizvodi previše hormona koji se naziva adrenokortikotropni hormon (ACTH), što pak rezultira pretjeranom proizvodnjom drugog hormona koji se zove kortizol.
If you are using medicine to treat a heart condition, your doctor may also need to adjust its dosage.
Ako uzimate lijek za liječenje srca, liječnik će možda trebati prilagoditi njegovu dozu.
In patients who developed hyperglycaemia, the condition generally appeared to respond to antidiabetic therapy.
U bolesnika u kojih se razvila hiperglikemija, čini se da je stanje općenito odgovaralo na antidijabetičku terapiju.
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.
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.
Renal clearance has a minor contribution to the elimination of pasireotide in humans.
Bubrežni klirens malo doprinosi eliminaciji pasireotida u ljudi.
Gastrointestinal disorders were frequently reported with Signifor.
Poremećaji probavnog sustava su često prijavljivani sa Signiforom.
If a dose of Signifor is missed the missed injection should be administered as soon as possible.
Ako se propusti doza Signifora, propuštenu injekciju potrebno je što prije primijeniti.
A total of 201 Cushing's disease patients received Signifor in phase II and III studies.
Ukupno 201 bolesnik s Cushingovom bolešću primao je Signifor u ispitivanjima faze II i III.
If side effects occur your doctor may temporarily reduce your dose by 0.3 mg per injection.
Ako dođe do nuspojava, liječnik Vam može privremeno smanjiti dozu za 0,3 mg po injekciji.
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.
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.
DO NOT USE if it is broken or if the liquid looks cloudy or contains particles.
NE KORISTITE ju ako je razbijena ili ako tekućina izgleda zamućeno ili sadrži čestice.
Type 2 diabetes mellitus, glucose tolerance impaired, decreased appetite
Šećerna bolest tipa 2, poremećena tolerancija glukoze, smanjeni apetit
Preferred injection sites for subcutaneous injections are the top of the thighs and the abdomen (excluding the navel or waistline).
Najbolja mjesta za davanje supkutanih injekcija su prednji dio bedara i trbuh (isključujući područje pupka i struka).
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%).
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%).
Pasireotide 0.9 mg twice daily % change (n)
Pasireotid 0,9 mg dvaput na dan % promjene (n)
In clinical studies in Cushing's disease patients, QTcF of >500 msec was observed in two out of 201 patients.
U kliničkim ispitivanjima s bolesnicima oboljelima od Cushingove bolesti bio je uočen QTcF od >500 msec u dva od 201 bolesnika.
Patients who experience a significant reduction in urinary free cortisol (UFC) levels should continue to receive Signifor for as long as benefit is derived.
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.
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.
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.
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.
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.
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%).
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%).
A sharps container or other rigid closed disposal container
Spremnik za oštre predmete ili neki drugi čvrsti, zatvoreni spremnik za otpad
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).
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).
Signifor may have a minor influence on the ability to drive and use machines.
Signifor može imati mali utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
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%).
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%).
Pasireotide intramuscular use n (%) N=176
Pasireotid primijenjen intramuskularno n (%) N=176
Adverse reactions are listed according to MedDRA primary system organ class.
Nuspojave su navedene po primarnom organskom sustavu prema MedDRA-i.
Table 5 Key results - phase III study in Cushing's disease patients (intramuscular formulation)
Tablica 5 Ključni rezultati - ispitivanje faze III u bolesnika s Cushingovom bolešću (intramuskularna formulacija)
Pasireotide 0.6 mg twice daily % change (n)
Pasireotid 0,6 mg dvaput na dan % promjene (n)
Slowly depress the plunger until the syringe is empty.
Polako pritišćite klip dok se štrcaljka ne isprazni.
Pasireotide may decrease the relative bioavailability of ciclosporin.
Pasireotid bi mogao smanjiti relativnu bioraspoloživost ciklosporina.
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.
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.
At month 12, reduction in tumour volume was comparable between the treatment groups and in patients with and without previous pituitary surgery.
U 12. mjesecu smanjenje u volumenu tumora bilo je usporedivo između terapijskih skupina i u bolesnika s prethodnom operacijom hipofize ili bez nje.
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.
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.
The patient should be monitored for response and tolerability and further dose adjustments may be needed.
Potrebno je u bolesnika pratiti odgovor i podnošljivost te mogu biti potrebne daljnje prilagodbe doze.
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.
Nuspojave navedene u Tablici 1 uključuju događaje prijavljene u ključnim ispitivanjima s intramuskularnom formulacijom u bolesnika s akromegalijom i s Cushingovom bolešću.
Octreotide intramuscular use n (%) N=182
Oktreotid primijenjen intramuskularno n (%) N=182
Median change in UFC (% from baseline)
Medijan promjene UFC-a (% od početne vrijednosti)
The degree of hyperglycaemia appeared to be higher in patients with pre-diabetic conditions or established diabetes mellitus.
Čini se da je stupanj hiperglikemije bio viši u bolesnika s pred-dijabetičkim stanjima ili ustanovljenom šećernom bolešću.
Ampoules of Signifor of different strengths (0.3 mg, 0.6 mg and 0.9 mg) are available to match the specific dose prescribed by your doctor.
Dostupne su ampule Signifora različitih jačina (0,3 mg, 0,6 mg i 0,9 mg) kako bi odgovarale specifičnoj dozi koju Vam je propisao liječnik.
The apparent clearance (CL/F) of pasireotide intramuscular use in healthy volunteers is on average 4.5-8.5 litres/h.
Prividni klirens (CL/F) pasireotida primijenjenog intramuskularno u zdravih dobrovoljaca u prosjeku je 4,5-8,5 litara/h.
In healthy volunteers, pasireotide is widely distributed with large apparent volume of distribution (Vz/F >100 litres).
U zdravih dobrovoljaca pasireotid ima opsežnu distribuciju uz veliki volumen distribucije (Vz/F >100 litara).
It is not known whether Signifor passes into breast milk.
Nije poznato prelazi li Signifor u majčino mlijeko.
How long to use Signifor
Koliki dugo primjenjivati Signifor
If hyperglycaemia develops in a patient being treated with Signifor, the initiation or adjustment of antidiabetic treatment is recommended, following the established treatment guidelines for the management of hyperglycaemia.
Ako se razvije hiperglikemija kod bolesnika koji se liječi Signiforom, preporučuje se započeti ili prilagoditi antidijabetičko liječenje, slijedeći utvrđene terapijske smjernice za zbrinjavanje hiperglikemije.
Patients who did not meet these criteria were unblinded and the dose was increased by 0.3 mg twice daily.
Za bolesnike koji nisu ispunili te kriterije liječenje je bilo razotkriveno, a doza je povećana za 0,3 mg dvaput na dan.
This means that it is injected through a needle into the muscles of your buttocks.
To znači da se ubrizgava kroz iglu u mišić na Vašoj stražnjici.
Put the cover back on the needle.
Vratite poklopac na iglu.
Injection site reactions were reported in 13.6% of patients enrolled in the phase III study in Cushing's disease.
Reakcije na mjestu primjene injekcije bile su prijavljene u 13,6% bolesnika uključenih u ispitivanje faze III kod Cushingove bolesti.
Dose adjustment of medicinal products such as beta blockers, calcium channel blockers, or medicinal products to control electrolyte balance, may be necessary (see also section 4.5).
U tim slučajevima može biti potrebno prilagođavanje doze lijekova kao što su beta blokatori, blokatori kalcijevih kanala ili drugi lijekovi za kontroliranje ravnoteže elektrolita (vidjeti također dio 4.5).
Decreases in sitting systolic and diastolic blood pressure, body mass index (BMI) and total cholesterol were observed in both dose groups at month 6.
Smanjenja u sistoličkom i dijastoličkom krvnom tlaku u sjedećem položaju, indeksu tjelesne težine (BMI) i ukupnom kolesterolu bila su uočena u obje dozne skupine u 6. mjesecu.
Dose adjustments (decrease or increase) of insulin and antidiabetic medicinal products (e.g. metformin, liraglutide, vildagliptin, nateglinide) may be required when administered concomitantly with pasireotide (see also section 4.4).
Prilagođavanja doze (smanjenje ili povećanje) inzulina i antidijabetika (npr. metformina, liraglutida, vildagliptina, nateglinida) može biti potrebno kada se ti lijekovi primjenjuju istodobno s pasireotidom (vidjeti također dio 4.4).
Table 4 Key results at month 12 - phase III study in acromegaly patients
Tablica 4 Ključni rezultati u 12. mjesecu - ispitivanje faze III u bolesnika s akromegalijom
In both studies, mean FPG and HbA1c levels peaked within the first three months of treatment with pasireotide intramuscular use.
U oba ispitivanja, srednje razine FPG-a i HbA1c dosegle su vršne vrijednosti unutar prva tri mjeseca liječenja pasireotidom primijenjenim intramuskularno.
The elevations were mostly low grade and reversible while continuing treatment.
Povišenja su bila uglavnom niskog stupnja i reverzibilna uz nastavak liječenja.
Remove the lid film of the vial adapter packaging, but do NOT remove the vial adapter from its packaging.
Uklonite film kojim je pokriveno pakiranje nastavka za bočicu, ali NEMOJTE vaditi nastavak za bočicu iz njegovog pakiranja.
The safety profile of pasireotide intramuscular use was largely similar between the acromegaly and Cushing's disease indications.
Sigurnosni profil pasireotida koji se primjenjuje intramuskularno uvelike je bio sličan između indikacija akromegalije i Cushingove bolesti.
After four months of treatment, patients with mUFC ≤1.5xULN continued on the blinded dose to which they were randomised, and patients with mUFC >1.5xULN had their doses increased in a blinded manner from 10 mg to 30 mg, or from 30 mg to 40 mg, provided there were no tolerability concerns.
Nakon četiri mjeseca liječenja, bolesnici koji su imali mUFC ≤1,5xGGN nastavili su primati slijepu dozu na koju su bili randomizirani, a bolesnicima koji su imali mUFC >1,5xGGN doze su povećane na zaslijepljeni način s 10 mg na 30 mg, ili s 30 mg na 40 mg, pod uvjetom da nije bilo problema s podnošljivošću.
Your doctor may want to monitor your blood sugar and start treatment with or adjust your antidiabetic medicine.
Liječnik će možda htjeti pratiti razinu šećera u Vašoj krvi te započeti liječenje antidijabetikom ili prilagoditi antidijabetik koji uzimate.
Anticipated pharmacokinetic interactions resulting in effects on other medicinal products
Očekivane farmakokinetičke interakcije koje utječu na druge lijekove
The study met the primary efficacy objective for both dose groups (lower bound of the 95% CI for the response rate of each treatment arm >15%).
Ispitivanje je ispunilo svoj primarni cilj djelotvornosti za obje dozne skupine (donja granica 95%-tnog CI za stopu odgovora svake terapijske skupine >15%).
Not all pack sizes or strengths may be marketed.
Na tržištu se ne moraju nalaziti sve jačine ili veličine pakiranja.
81 patients were crossed over from octreotide intramuscular use to pasireotide intramuscular use, and 38 patients were crossed over from pasireotide intramuscular use to octreotide intramuscular use.
81 bolesnik je prešao s oktreotida primijenjenog intramuskularno na pasireotid primijenjen intramuskularno, a 38 bolesnika je prešlo s pasireotida primijenjenog intramuskularno na oktreotid primijenjen intramuskularno.
Management of suspected adverse reactions at any time during the treatment may require temporary dose reduction of Signifor.
Zbrinjavanje u slučaju sumnje na nuspojave u bilo kojem trenutku tijekom liječenja moglo bi zahtijevati privremeno smanjenje doze Signifora.
Inadequately controlled patients in study C2402 are defined as patients with a mean GH concentration of a 5-point profile over a 2-hour period >2.5 μg/l and sex- and age-adjusted IGF-1 >1.3 × ULN.
Neodgovarajuće kontrolirani bolesnici u ispitivanju C2402 definirani su kao bolesnici sa srednjom koncentracijom GH-a na profilu od 5 točaka tijekom razdoblja od 2 sata >2,5 μg/l i IGF-1 prilagođenim za spol i dob od >1,3 x GGN.