FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Če je takšna zamenjava potrebna, se priporoča interval vsaj 28 dni med zadnjim injiciranjem intramuskularne oblike in prvim injiciranjem subkutane oblike ter začetno odmerjanje subkutane oblike zdravila v odmerku 0,6 mg pasireotida dvakrat dnevno.
English: ATTENTION: It is essential to start the reconstitution process only after the injection kit reaches room temperature.
Slovenian: OPOZORILO: Pomembno je, da s postopkom rekonstitucije začnete šele po tem, ko se komplet za injiciranje ogreje na sobno temperaturo.
English: Signifor 40 mg and Signifor 60 mg are also available in multipacks containing 3 intermediate packs.
Slovenian: Zdravili Signifor 40 mg in Signifor 60 mg sta na voljo tudi v skupnih pakiranjih, ki vsebujejo po 3 vmesna pakiranja.
English: Sites showing signs of inflammation or irritation should be avoided.
Slovenian: Pri tem se je treba izogibati mest, ki kažejo znake vnetja ali draženja.
English: Tap the syringe with your fingers to get rid of air bubbles.
Slovenian: S prsti rahlo krcnite brizgo, da se znebite zračnih mehurčkov.
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.
Slovenian: Po posamezni injekciji se koncentracija pasireotida v plazmi na dan injekcije sprva močno zviša, nato se od 2. do 7. dne znižuje, sledita pa počasno zviševanje do najvišje koncentracije, ki jo pasireotid doseže okrog 21. dne, in faza počasnega zniževanja koncentracije v nadaljnjih nekaj tednih, ki poteka sočasno s fazo dokončne razgradnje polimernega matriksa te odmerne oblike zdravila.
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.
Slovenian: Po zaključku osnovne faze so bolnikom, ki so dosegli biokemijsko urejenost ali jim je zdravljenje po oceni raziskovalca koristilo na drug način, omogočili, da so zdravljenje nadaljevali še v fazi podaljšanja, in sicer z zdravilom, ki jim je bilo z randomizacijo dodeljeno na začetku.
English: • metformin, liraglutide, vildagliptin, nateglinide (antidiabetic medicines).
Slovenian: • metformin, liraglutid, vildagliptin, nateglinid (antidiabetiki).
English: Pasireotide for intramuscular use is formulated as microspheres for long-acting release.
Slovenian: Pasireotid za intramuskularno uporabo je izdelan v obliki mikrokroglic z dolgotrajnim sproščanjem.
English: The dose may be titrated every 2 to 4 months based on response and tolerability.
Slovenian: Odmerek se lahko titrira vsake 2 do 4 mesece na osnovi odziva na zdravljenje in prenašanje zdravila.
English: 6 ampoules.
Slovenian: 6 ampul.
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.
Slovenian: Po podatkih analize populacijske farmakokinetike je bil ocenjeni CL/F približno 4,8 do 6,5 litra/h pri tipičnih bolnikih s Cushingovo boleznijo in približno 5,6 do 8,2 litra/h pri tipičnih bolnikih z akromegalijo.
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.
Slovenian: Če imate jetrno bolezen že pred začetkom zdravljenja akromegalije z zdravilom Signifor, vam bo zdravnik za začetek morda predpisal odmerek 20 mg.
English: It is not known whether Signifor passes into breast milk.
Slovenian: Ni znano, ali zdravilo Signifor prehaja v materino mleko.
English: Decreased total body clearance and increased pharmacokinetic exposures have been seen with increasing age.
Slovenian: Pri višji starosti so opažali zmanjšan celokupni telesni očistek in povečano farmakokinetično izpostavljenost zdravilu.
English: Severe hepatic impairment (Child Pugh C).
Slovenian: Huda okvara jeter (Child Pugh stopnje C).
English: • calcium channel blockers (bepridil, verapamil, diltiazem)
Slovenian: • zaviralci kalcijevih kanalčkov (bepridil, verapamil, diltiazem)
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).
Slovenian: Pri Cushingovi bolezni ocena varnosti oblike za intramuskularno dajanje temelji na podatkih 150 bolnikov, ki so prejemali pasireotid v študiji faze III z oznako G2304 (mediano trajanje izpostavljenosti zdravilu: 57 tednov).
English: Signifor may have a minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Signifor ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Thereafter liver function should be monitored as clinically indicated.
Slovenian: Kasneje je treba jetrno funkcijo določati le, če je to klinično indicirano.
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.
Slovenian: Rezultati študij in vitro so pokazali, da je na kortikotropnih tumorskih celicah bolnikov s Cushingovo boleznijo v velikem obsegu izražena podvrsta receptorja hsst5, medtem ko druge podvrste receptorja sploh niso izražene ali pa so izražene v manjši meri.
English: Most findings seen in repeated toxicity studies were reversible and attributable to the pharmacology of pasireotide.
Slovenian: Učinki, ki so jih opažali v študijah toksičnosti pri ponavljajočih se odmerkih, so bili večinoma reverzibilni in jih je bilo mogoče pripisati farmakološkemu delovanju pasireotida.
English: Paediatric population No studies have been performed in paediatric patients.
Slovenian: Pediatrična populacija Študij pri pediatričnih bolnikih niso izvajali.
English: Important safety information Caution: Keep the ampoules out of the reach of children.
Slovenian: Pomembna opozorila za varno uporabo Pozor: Ampule shranjujte nedosegljivo otrokom.
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Slovenian: V predkliničnih študijah so učinke opažali samo pri izpostavljenostih, ki so dovolj presegale največjo izpostavljenost pri človeku, tako da pomen teh učinkov za klinično uporabo skorajda ni pomemben.
English: The presence of gallstones in Signifor-treated patients is largely asymptomatic; symptomatic stones should be managed according to clinical practice.
Slovenian: Pri bolnikih, ki prejemajo zdravilo Signifor, je prisotnost žolčnih kamnov večinoma asimptomatska, simptomatske žolčne kamne pa je treba zdraviti v skladu s klinično prakso.
English: The data described below reflect exposure of 162 Cushing's disease patients to Signifor in the phase III study.
Slovenian: Spodaj prikazani podatki odražajo izpostavljenost zdravilu Signifor pri 162 bolnikih s Cushingovo boleznijo v študiji faze III.
English: Based on the accumulation ratios of AUC, the calculated effective half-life (t1/2,eff) in healthy volunteers was approximately 12 hours.
Slovenian: Efektivni razpolovni čas (t1/2,eff), izračunan iz razmerja kopičenja na podlagi vrednosti AUC, je pri zdravih prostovoljcih znašal približno 12 ur.
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.
Slovenian: Glede na izvide in vaše počutje vam bo zdravnik morda moral zvišati ali znižati odmerek zdravila Signifor v vsaki injekciji.
English: To reduce local discomfort, it is recommended that the solution is at room temperature before administration.
Slovenian: Zaradi zmanjšanja lokalnega neugodja se priporoča, da je raztopina pred injiciranjem sobne temperature.
English: Injection site reactions were also reported in clinical studies in other populations.
Slovenian: O reakcijah na mestu injiciranja so poročali tudi v drugih kliničnih študijah z drugimi populacijami preiskovancev.
English: How long to use Signifor You should continue using Signifor for as long as your doctor tells you to.
Slovenian: Kako dolgo je treba uporabljati zdravilo Signifor Zdravilo Signifor uporabljajte tako dolgo, kot vam naroči zdravnik.
English: Overall reductions in these parameters tended to be greater in patients that were mUFC responders.
Slovenian: V celoti je bilo znižanje vrednosti navedenih parametrov večinoma večje pri bolnikih z odzivom vrednosti mUFC.
English: Ampoules should be opened just prior to administration, and any unused portion discarded.
Slovenian: Ampule je treba odpreti tik pred injiciranjem in neporabljen del zavreči.
English: An audible “click” confirms proper activation.
Slovenian: Ob uspešni aktivaciji lahko slišite "klik".
English: These reactions were usually of low grade, required no intervention and improved with continued treatment.
Slovenian: Ti učinki so bili običajno nizke stopnje, zdravstveni posegi pa zaradi njih niso bili potrebni in so se z nadaljevanjem zdravljenja izboljšali.
English: Within each system organ class, adverse reactions are ranked by frequency.
Slovenian: V posamezni skupini organskega sistema so neželeni učinki navedeni po pogostnosti.
English: FPG/HbA1c monitoring during treatment should follow established guidelines.
Slovenian: Razmerje FPG/HbA1c je treba v času zdravljenja spremljati v skladu z veljavnimi smernicami.
English: This variation is moderate and considered of minor significance considering the wide age range in which the effect was observed.
Slovenian: To odstopanje je zmerno in mu ne pripisujejo večjega pomena glede na to, da ga opažajo šele pri veliki starostni razliki.
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.
Slovenian: Nenadno, popolno ali skoraj popolno zaviranje sproščanja ACTH zniža koncentracijo kortizola v krvnem obtoku in lahko povzroči prehoden hipokortizolizem/hipoadrenalizem.
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.
Slovenian: V študiji pre- in postnatalnega obdobja pri podganah pasireotid ni vplival na popadke in porod, je pa povzročil manjši zaostanek v razvoju uhljev in zmanjšano telesno maso mladičev.
English: Slowly release the skin fold and gently pull the needle out.
Slovenian: Počasi spustite kožno gubo in nežno izvlecite iglo.
English: Due to the increase in unbound drug exposure, Signifor should be used with caution in patients with severe renal impairment or end stage renal disease (see section 5.2).
Slovenian: Zaradi povečane izpostavljenosti nevezanemu zdravilu je treba zdravilo Signifor uporabljati previdno pri bolnikih s hudo okvaro ledvic ali končno ledvično odpovedjo (glejte poglavje 5.2).
English: If you interrupt your treatment with Signifor your symptoms may come back.
Slovenian: Če prekinete zdravljenje z zdravilom Signifor, se lahko simptomi bolezni vrnejo.
English: Remove the injection kit from the fridge and let the kit stand at room temperature for a minimum of 30 minutes before reconstitution, but do not exceed 24 hours.
Slovenian: Komplet za injiciranje vzemite iz hladilnika in ga pred rekonstituiranjem pustite na sobni temperaturi najmanj 30 minut, vendar ne več kot 24 ur.
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.
Slovenian: Po več mesečnih odmerkih je farmakokinetična izpostavljenost pasireotidu za intramuskularno uporabo približno sorazmerna z višino odmerka v okviru odmerjanja od 10 mg do 60 mg vsake 4 tedne.
English: Note: If not used within 24 hours, the injection kit can be returned to the fridge.
Slovenian: Opomba: Če kompleta niste uporabili v roku 24 ur, ga lahko ponovno shranite v hladilnik.
English: Bradycardia has been reported with the use of pasireotide (see section 4.8).
Slovenian: Pri uporabi pasireotida so poročali o bradikardiji (glejte poglavje 4.8).
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.
Slovenian: V primeru dokazanega hipokortizolizma je v nekaterih primerih treba začasno uvesti nadomestno eksogeno steroidno (glukokortikoidno) zdravljenje in/ali znižati oziroma prekiniti odmerjanje zdravila Signifor.
English: Signifor should not be used in patients with severe hepatic impairment (Child Pugh C) (see sections 4.3 and 4.4).
Slovenian: Zdravila Signifor se ne sme uporabljati pri bolnikih s hudo okvaro jeter (Child Pugh stopnje C) (glejte poglavji 4.3 in 4.4).
English: The efficacy of pasireotide intramuscular use has been demonstrated in two phase III, multicentre studies in acromegaly patients and in one phase III, multicentre study in Cushing's disease patients.
Slovenian: Učinkovitost pasireotida za intramuskularno uporabo so dokazali v dveh multicentričnih študijah faze III pri bolnikih z akromegalijo in v eni multicentrični študiji faze III pri bolnikih s Cushingovo boleznijo.
English: Maximum allowed dose was 60 mg for pasireotide intramuscular use and 30 mg for octreotide intramuscular use.
Slovenian: Najvišji dovoljeni odmerek je bil 60 mg za pasireotid za intramuskularno uporabo in 30 mg za oktreotid za intramuskularno uporabo.
English: Three-quarters of patients had previously been treated with octreotide intramuscular use and a quarter with lanreotide deep subcutaneous injection.
Slovenian: Tri četrtine bolnikov je predhodno prejemalo oktreotid za intramuskularno uporabo, ena četrtina pa lanreotid za globoko subkutano injiciranje.
English: If you interrupt your treatment with Signifor your cortisol level may increase again and your symptoms may come back.
Slovenian: Če prekinete zdravljenje z zdravilom Signifor, se vam lahko spet zviša raven kortizola, simptomi bolezni pa se lahko povrnejo.
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.
Slovenian: Če ste noseči ali mislite, da bi lahko bili, je pomembno, da to poveste zdravniku in se z njim pogovorite, ali lahko uporabljate zdravilo Signifor med nosečnostjo ali ne. - V času uporabe zdravila Signifor ne smete dojiti.
English: 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.
Slovenian: 81 bolnikov je prešlo z intramuskularne uporabe oktreotida na intramuskularno uporabo pasireotida, 38 bolnikov pa je prešlo z intramuskularne uporabe pasireotida na intramuskularno uporabo oktreotida.
English: If concomitant use of coumarin-derivative or heparin-derivative anticoagulants with Signifor intramuscular use cannot be avoided, patients should be monitored regularly for alterations in their coagulation parameters (PT and PTT) and the anticoagulant dose adjusted accordingly.
Slovenian: Če se sočasni uporabi zdravila Signifor za intramuskularno uporabo in antikoagulantov, ki so derivati kumarina ali heparina, ni mogoče izogniti, je treba bolnike redno spremljati glede sprememb koagulacijskih parametrov (PČ in PTČ) in ustrezno prilagajati odmerke antikoagulantov.
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).
Slovenian: Iz tega razloga je treba spremljati bolnika in ga poučiti o znakih in simptomih, ki so povezani s hipokortizolizmom (na primer šibkost, utrujenost, anoreksija, navzea, bruhanje, hipotenzija, hiperkaliemija, hiponatriemija, hipoglikemija).
English: Results are the meanSEM of IC50 values expressed as nmol/l.
Slovenian: Rezultati so navedeni kot povprečna vrednost  standardna napaka ocene povprečja (SEM) vrednosti IC50 in izraženi v nmol/l.
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.
Slovenian: V celoti je bilo znižanje vrednosti navedenih parametrov opazno pri povsem in deloma urejenih bolnikih glede na povprečno vrednost UFC, vendar je bilo nekoliko večje pri bolnikih, pri katerih je prišlo do normalizacije vrednosti UFC.
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.
Slovenian: Pri tem lahko deluje premočno in lahko pride do znakov in simptomov, ki so povezani s pomanjkanjem kortizola, kot so izredna šibkost, utrujenost, zmanjšanje telesne mase, občutek slabosti, bruhanje ali nizek krvni tlak.
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.
Slovenian: Odmerek se lahko zviša na največ 60 mg pri bolnikih, pri katerih koncentraciji rastnega hormona in/ali insulinu podobnega rastnega faktorja-1 (IGF-1) nista povsem urejeni po 3 mesecih zdravljenja z zdravilom Signifor v odmerku 40 mg.
English: If you forgot to inject a dose of Signifor, simply inject the next dose at the scheduled time.
Slovenian: Če ste si pozabili injicirati odmerek zdravila Signifor, si preprosto injicirajte naslednji odmerek po razporedu.
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.
Slovenian: Analiza populacijske farmakokinetike kaže, da na osnovi Cmax in AUC pride pri 90 % bolnikov s Cushingovo boleznijo do stanja dinamičnega ravnovesja po približno 1,5 oziroma 15 dneh.
English: Table 5 Key results - phase III study in Cushing's disease patients (intramuscular formulation)
Slovenian: Preglednica 5 Glavni rezultati - študija faze III pri bolnikih s Cushingovo boleznijo (intramuskularna oblika zdravila)
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:
Slovenian: Posebej pomembno je, da zdravniku poveste, če uporabljate katero od naslednjih zdravil: - ciklosporin (ki ga uporabljamo po presaditvah organov za zaviranje delovanja imunskega sistema); - zdravila za urejanje ravni krvnega sladkorja, kadar so previsoke (kot pri sladkorni bolezni) ali prenizke (hipoglikemija), kot so:
English: Baseline demographics were well balanced between the two randomised dose groups and consistent with the epidemiology of the disease.
Slovenian: Izhodiščni demografski podatki so bili v obeh randomiziranih skupinah enakomerno razporejeni in skladni z epidemiologijo bolezni.
English: In a clinical study with single subcutaneous dose administration of 900 µg pasireotide in subjects with impaired renal function, renal impairment of mild, moderate or severe degree, or end stage renal disease (ESRD) did not have a significant impact on total pasireotide plasma exposure.
Slovenian: V klinični študiji z enkratnim subkutanim odmerkom 900 µg pasireotida pri osebah z okvaro ledvic, okvara blage, zmerne ali hude stopnje ali končna odpoved ledvic ni pomembno vplivala na izpostavljenost celotnemu pasireotidu v plazmi.
English: The patient should be monitored for response and tolerability and further dose adjustments may be needed.
Slovenian: Bolnika je treba spremljati glede odziva na zdravljenje in prenašanja zdravila in po potrebi prilagoditi odmerjanje.
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.
Slovenian: Pri bolnikih, ki so prejemali pasireotid za intramuskularno uporabo in pri katerih so opažali znižanje vrednosti rastnega hormona in faktorja IGF-1, je do teh sprememb prišlo v prvih 3 mesecih zdravljenja, ohranile pa so se tudi do konca 24. tedna zdravljenja.
English: Especially, tell your doctor if you are using: - medicines to treat irregular heartbeat, such as medicines containing disopyramide,
Slovenian: Obvestite svojega zdravnika zlasti če uporabljate: - zdravila za zdravljenje nepravilnega srčnega ritma, kot so zdravila, ki vsebujejo dizopiramid,
English: Liver tests
Slovenian: Jetrni testi
English: Patients who did not meet these criteria were unblinded and the dose was increased by 0.3 mg twice daily.
Slovenian: Pri bolnikih, ki tem kriterijem niso ustrezali, so zdravljenje razkrili in jim povečali odmerek za 0,3 mg dvakrat na dan.
English: • cholinesterase inhibitors (rivastigmine, physostigmine); - medicines to control the balance of electrolytes (potassium, magnesium) in your body.
Slovenian: • zaviralci holinesteraze (rivastigmin, fizostigmin); - zdravila za vzdrževanje ravnovesja elektrolitov (kalija, magnezija) v telesu.
English: These episodes were sporadic and of single occurrence with no clinical consequence observed.
Slovenian: Do navedenega pojava je prihajalo sporadično in po enkrat pri posameznem bolniku, pri tem pa niso opažali nobenih kliničnih posledic.
English: If side effects occur your doctor may temporarily reduce your dose by 0.3 mg per injection.
Slovenian: Če pride do neželenih učinkov, vam lahko zdravnik začasno zniža odmerek za 0,3 mg pri vsakem injiciranju.
English: The study met the primary efficacy objective for the 0.9 mg twice-daily group as the lower limit of the 95% CI is greater than the pre-specified 15% boundary.
Slovenian: V študiji so dosegli primarni cilj učinkovitosti v skupini z odmerkom 0,9 mg dvakrat na dan, saj je bila pri tej skupini spodnja meja 95-odstotnega intervala zaupanja višja od vnaprej določene meje 15 %.
English: lumefantrine); - medicines to control blood pressure such as:
Slovenian: - zdravila za uravnavanje krvnega tlaka, kot so:
English: Withdraw the needle from the injection site and activate the safety guard.
Slovenian: Izvlecite iglo z mesta injiciranja in aktivirajte varnostni ščitnik.
English: DO NOT USE if it is broken or if the liquid looks cloudy or contains particles.
Slovenian: NE UPORABLJAJTE je, če je poškodovana ali če je tekočina v njej videti motna ali vsebuje delce.
English: If you are using medicine to treat a heart condition, your doctor may also need to adjust its dosage.
Slovenian: Če uporabljate zdravila za srce, vam bo moral zdravnik morda prilagoditi tudi odmerjanje teh zdravil.
English: These reactions resolved spontaneously and required no intervention.
Slovenian: Navedene reakcije so spontano izzvenele in zaradi njih ni bil potreben dodaten zdravstveni poseg.
English: During your treatment with Signifor: - Signifor may cause your blood sugar to increase.
Slovenian: V času zdravljenja z zdravilom Signifor - Zdravilo Signifor vam lahko zviša koncentracijo sladkorja v krvi.
English: This is a long-term treatment, possibly lasting for years.
Slovenian: Kako dolgo je treba uporabljati zdravilo Signifor Gre za dolgotrajno zdravljenje, ki lahko traja tudi več let.