FrancophonIA/ELRC3.0 huggingface dataset:
English: What you need to know before you use Signifor
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Signifor
English: Therefore, do not stop using Signifor unless your doctor tells you to.
Slovenian: Iz tega razloga ne prenehajte uporabljati zdravila Signifor, razen če vam tako naroči zdravnik.
English: At the end of the core phase, patients not adequately responding to their initial therapy were allowed to switch treatment.
Slovenian: Po zaključku osnovne faze so bolnikom, pri katerih ni prišlo do ustreznega odziva na začetno zdravljenje, omogočili, da so zamenjali zdravilo.
English: Signifor reduces the production of these hormones and possibly also the size of the adenoma.
Slovenian: Zdravilo Signifor zmanjšuje tvorbo teh hormonov in lahko zmanjša tudi obseg adenoma.
English: Grade 1 and 2 adverse reactions were reported in 57.4% of patients.
Slovenian: O neželenih učinkih 1. in 2. stopnje so poročali pri 57,4 % bolnikov.
English: Other medicines and Signifor
Slovenian: Druga zdravila in zdravilo Signifor
English: The injection site is the place on your body where you are going to give yourself the injection.
Slovenian: Mesto injiciranja je mesto na vašem telesu, kamor si boste injicirali zdravilo.
English: Octreotide intramuscular use n (%) N=182
Slovenian: oktreotid intramuskularna uporaba n (%) N=182
English: Each ampoule is packed in a cardboard tray which is placed in an outer box.
Slovenian: Vsaka ampula leži na kartonskem podstavku, ki je pakiran v zunanjo škatlo.
English: If you are using other medicines at the same time as Signifor (including medicines obtained without a prescription), your doctor may need to monitor your heart more carefully or change the dose of Signifor or the other medicines.
Slovenian: Če sočasno z zdravilom Signifor uporabljate še druga zdravila (vključno z zdravili, ki jih lahko dobite brez recepta), vam bo moral morda zdravnik bolj skrbno pregledovati srce ali spremeniti odmerek zdravila Signifor oziroma odmerke drugih zdravil.
English: Available toxicological data in animals have shown excretion of pasireotide in milk.
Slovenian: Razpoložljivi toksikološki podatki pri živalih kažejo na izločanje pasireotida v mleko.
English: Carcinogenicity studies conducted in rats and transgenic mice did not identify any carcinogenic potential.
Slovenian: V študijah kancerogenosti, ki so jih izvajali na podganah in transgenskih miših, niso odkrili, da bi imel pasireotid kancerogeni potencial.
English: This medicine will be given to you by a trained healthcare professional.
Slovenian: To zdravilo vam bo dajal usposobljen zdravstveni delavec.
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.
Slovenian: V primeru prevelikega odmerjanja je priporočeno začeti z ustreznim podpornim zdravljenjem v skladu z bolnikovim kliničnim stanjem, dokler simptomi niso odpravljeni.
English: This may involve measuring the levels of cortisol in your blood or urine.
Slovenian: To lahko vključuje merjenje ravni kortizola v krvi in urinu.
English: If you have been told to use two needles, you should now replace the long needle with the short one.
Slovenian: Če so vam naročili, da uporabljate dve igli, morate zdaj zamenjati dolgo iglo s kratko.
English: Anticipated pharmacodynamic interactions
Slovenian: Predvidene farmakodinamične interakcije
English: Tell your doctor straight away if you get any of the following:
Slovenian: Takoj povejte zdravniku, če se pri vas pojavi kateri od naslednjih neželenih učinkov:
English: - Store in a refrigerator (2°C-8°C).
Slovenian: - Shranjujte v hladilniku (2 °C-8 °C).
English: Data on Cushing's disease patients older than 65 years are limited but do not suggest any clinically significant differences in safety and efficacy in relation to younger patients.
Slovenian: Podatkov o bolnikih, ki imajo Cushingovo bolezen in so stari več kot 65 let, je malo, vendar ne kažejo klinično pomembnih razlik glede varnosti in učinkovitosti zdravila v primerjavi z mlajšimi bolniki.
English: The patient should be evaluated for clinical benefit after the first month of treatment and periodically thereafter.
Slovenian: Bolnika je treba oceniti glede kliničnih koristi po prvem mesecu zdravljenja in nato redno tekom zdravljenja.
English: - your doctor may also wish to check your gallbladder, liver enzymes and pituitary hormones periodically, since these might all be affected by this medicine.
Slovenian: - Zdravnik vam bo morda želel redno pregledovati tudi žolčnik in vrednosti jetrnih encimov ter hipofiznih hormonov, saj to zdravilo lahko vpliva nanje.
English: There is a limited amount of data from the use of pasireotide in pregnant women.
Slovenian: Podatkov o uporabi pasireotida pri nosečnicah je malo.
English: Fatigue includes fatigue and asthenia.
Slovenian: Utrujenost vključuje utrujenost in astenijo.
English: Pasireotide 10 mg N=74
Slovenian: pasireotid 10 mg N=74
English: Your doctor may wish to monitor your heart rate using a machine that measures electrical activity of the heart (an “ECG”, or electrocardiogram).
Slovenian: Zdravnik bo morda hotel spremljati vaš srčni utrip in vam posneti električno aktivnost srca (preiskava “EKG” oziroma elektrokardiogram).
English: The mean age of patients was approximately 40 years and the majority of patients (77.8%) were female.
Slovenian: Povprečna starost bolnikov je bila približno 40 let in večina bolnikov (77,8 %) je bila ženskega spola.
English: Ask your doctor about the need for contraception before taking this medicine.
Slovenian: O potrebi po kontracepciji se posvetujte z zdravnikom, preden začnete uporabljati to zdravilo.
English: In healthy volunteers, pasireotide is predominantly found in unchanged form in plasma, urine and faeces.
Slovenian: Pri zdravih prostovoljcih je pasireotid mogoče najti v plazmi, urinu in blatu pretežno v nespremenjeni obliki.
English: Pasireotide 30 mg N=76
Slovenian: pasireotid 30 mg N=76
English: Before you proceed to step 4, clean the injection site with an alcohol wipe.
Slovenian: Preden nadaljujete s 4. korakom, očistite mesto injiciranja z alkoholno blazinico.
English: Using Signifor at the same time each day will help you remember when to use your medicine.
Slovenian: Če boste uporabljali zdravilo Signifor vsak dan ob istem času, se boste laže spomnili, kdaj si ga morate odmeriti.
English: Withdraw the needle from the injection site and activate the safety guard (as shown in Step 8).
Slovenian: Izvlecite iglo z mesta injiciranja in aktivirajte varnostni ščitnik (kot je prikazano pri 8. koraku).
English: • The injection kit must reach room temperature.
Slovenian: • Komplet za injiciranje se mora ogreti na sobno temperaturo.
English: Pasireotide works in a very similar way to somatostatin.
Slovenian: Pasireotid deluje zelo podobno kot somatostatin.
English: No change in the pharmacokinetics (rate or extent of exposure) of pasireotide was observed.
Slovenian: Sprememb v farmakokinetiki pasireotida (v stopnji ali obsegu izpostavljenosti) niso opazili.
English: Keep the plunger pressed down and hold the syringe in place for 5 seconds.
Slovenian: Bat držite pritisnjen do konca in zadržite brizgo na mestu približno 5 sekund.
English: Never share needles and syringes.
Slovenian: Igel in brizg nikoli ne posojajte.
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.
Slovenian: Nežno stisnite kožo na mestu za injiciranje in zabodite iglo pod kotom približno 45 stopinj (kot je prikazano na sliki) v kožo na mestu injiciranja.
English: INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Slovenian: ŠKATLA ZA VMESNO PAKIRANJE V SKUPNEM PAKIRANJU (BREZ “BLUE BOX” PODATKOV)
English: Episodes of torsade de pointes were not observed either in those studies or in clinical studies in other patient populations.
Slovenian: Epizod torsade de pointes niso opažali niti v teh študijah niti v kliničnih študijah z drugimi populacijami bolnikov.
English: The site of repeat intramuscular injections should be alternated between the left and right gluteal muscle.
Slovenian: Nadaljnje intramuskularne injekcije je treba dajati izmenično v levo in desno glutealno mišico.
English: Patients should be advised to be cautious when driving or using machines if they experience fatigue, dizziness or headache during treatment with Signifor.
Slovenian: Bolnikom je treba svetovati previdnost pri vožnji ali upravljanju s stroji, če so med zdravljenjem z zdravilom Signifor utrujeni, omotični ali imajo glavobol.
English: Medicinal products that prolong the QT interval
Slovenian: Zdravila, ki podaljšujejo interval QT
English: Insulin and antidiabetic medicinal products
Slovenian: Insulin in antidiabetiki
English: - Signifor may lower your heart rate.
Slovenian: - Zdravilo Signifor vam lahko upočasni srčni utrip.
English: This means that it is injected through a short needle into the fatty tissue just under the skin.
Slovenian: To pomeni, da ga je s kratko iglo treba injicirati v maščobno tkivo tik pod kožo.
English: Two months after the start of Signifor therapy, patients should be evaluated for clinical benefit.
Slovenian: Dva meseca po začetku zdravljenja z zdravilom Signifor je treba oceniti klinične koristi zdravljenja za bolnika.
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.
Slovenian: Bolniki, pri katerih pride do pomembnega znižanja koncentracije prostega kortizola v urinu (angl. urinary free cortisol, UFC), bi morali še naprej prejemati zdravilo Signifor, dokler jim to koristi.
English: To prepare Signifor for deep intramuscular injection, please adhere to the following instructions:
Slovenian: Pri pripravi zdravila Signifor za globoko intramuskularno injiciranje upoštevajte naslednja navodila:
English: Pregnancy, breast-feeding and fertility Ask your doctor or pharmacist for advice before using any medicine.
Slovenian: Nosečnost, dojenje in plodnost Posvetujte se z zdravnikom ali s farmacevtom, preden uporabite katerokoli zdravilo.
English: * Cholecystitis includes cholecystitis acute
Slovenian: * holecistitis vključuje akutni holecistitis
English: Take the sterile syringe and attach the needle to it.
Slovenian: Vzemite sterilno brizgo in nanjo namestite iglo.
English: If you have any questions about how Signifor works or why this medicine has been prescribed for you, ask your doctor.
Slovenian: Če vas zanima, kako zdravilo Signifor deluje ali zakaj so vam predpisali to zdravilo, se obrnite na svojega zdravnika.
English: The dose should not exceed 60 mg.
Slovenian: Odmerek ne sme presegati 60 mg.
English: The 60 mg strength is only to be used in the treatment of acromegaly.
Slovenian: Zdravilo v jakosti 60 mg je namenjeno samo za zdravljenje akromegalije.
English: During the pivotal study, HbA1c levels increased significantly and stabilised but did not return to baseline values (see section 4.8).
Slovenian: Med potekom ključne študije so se vrednosti HbA1c bistveno povečale in nato stabilizirale, niso pa se vrnile na izhodiščno vrednost (glejte poglavje 4.8).
English: These receptor subtypes are expressed in different tissues under normal physiological conditions.
Slovenian: V normalnih fizioloških pogojih se te podvrste receptorjev izražajo v različnih tkivih.
English: Table 2 Binding affinities of somatostatin (SRIF-14), pasireotide, octreotide and lanreotide to the five human somatostatin receptor subtypes (hsst1-5)
Slovenian: Preglednica 2 Vezavne afinitete somatostatina (SRIF-14), pasireotida, oktreotida in lanreotida za pet humanih podvrst receptorjev za somatostatin (hsst1-5)
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).
Slovenian: O uporabi zdravila Signifor pri bolnikih, ki so stari več kot 65 let, je na voljo le malo podatkov, vendar ti ne kažejo, da bi bilo treba pri teh bolnikih prilagajati odmerjanje (glejte poglavje 5.2).
English: The apparent clearance (CL/F) of pasireotide intramuscular use in healthy volunteers is on average 4.5-8.5 litres/h.
Slovenian: Navidezni očistek (CL/F) pasireotida za intramuskularno uporabo je pri zdravih prostovoljcih v povprečju 4,5-8,5 l/h.
English: Cholecystitis includes cholecystitis acute and cholecystitis chronic.
Slovenian: Holecistitis vključuje akutni holecistitis in kronični holecistitis.
English: The dose should not exceed 40 mg.
Slovenian: Odmerek ne sme presegati 40 mg.
English: What Signifor is and what it is used for
Slovenian: Kaj je zdravilo Signifor in za kaj ga uporabljamo
English: Use of the same injection site for two consecutive injections is not recommended.
Slovenian: Za injiciranje ni priporočeno uporabiti istega injekcijskega mesta dvakrat zaporedoma.
English: A total of 181 patients completed the core phase (24 weeks) of the study.
Slovenian: Osnovno fazo v študiji (24 tednov) je zaključilo skupno 181 bolnikov.
English: For information on the instructions for use, please see the end of the package leaflet “How to inject Signifor”.
Slovenian: Za informacije glede napotkov za uporabo glejte zadnji del Navodila za uporabo “Kako injicirati zdravilo Signifor”.
English: Effect on female fertility
Slovenian: Vpliv na plodnost pri ženskah
English: If you stop using Signifor
Slovenian: Če ste prenehali uporabljati zdravilo Signifor
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.
Slovenian: Pogostnost in izraženost neželenih učinkov sta bili pogosto večji pri uporabi višjega začetnega odmerka 30 mg, vendar to ne velja za vse neželene učinke.
English: During the extension phase, 74 patients continued receiving pasireotide intramuscular use and 46 patients continued with octreotide intramuscular use treatment.
Slovenian: V fazi podaljšanja je 74 bolnikov še naprej prejemalo pasireotid za intramuskularno uporabo, 46 bolnikov pa je nadaljevalo zdravljenje z oktreotidom za intramuskularno uporabo.
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.
Slovenian: V študijah faze III so bile reakcije na mestu injiciranja (na primer bolečina na mestu injiciranja in neprijeten občutek na mestu injiciranja) večinoma stopnje 1 ali 2.
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, somatostatin and analogues, ATC code: H01CB05
Slovenian: Farmakoterapevtska skupina: hipofizni in hipotalamični hormoni ter sorodne učinkovine, somatostatin in analogi, oznaka ATC: H01CB05
English: The injection can be prepared using either two different needles to draw up and inject the solution or one short fine injection needle for both steps.
Slovenian: Injekcija se lahko pripravi bodisi z uporabo dveh različnih igel za vnos raztopine v brizgo ter za injiciranje raztopine, bodisi z uporabo ene kratke tanke injekcijske igle za oba koraka.
English: No QTcF values >500 ms were observed in any of the pivotal studies.
Slovenian: Intervalov QTcF s trajanjem > 500 ms niso opažali v nobeni od ključnih študij.
English: For a range of 60-100 kg the reduction in AUCss with increasing weight is predicted to be approximately 27%, which is considered moderate and of minor clinical significance.
Slovenian: Pri razponu telesne mase od 60 do 100 kg je mogoče predvideti, da se bo AUCss z višanjem telesne mase zmanjšala za približno 27 %, kar velja za zmerno zmanjšanje in nima večjega kliničnega pomena.
English: How much Signifor to use
Slovenian: Koliko zdravila Signifor uporabljati
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.
Slovenian: Povprečno trajanje izpostavljenosti zdravilu do vnaprej izbranega datuma za analizo primarnih ciljev učinkovitosti in varnosti je znašalo 10,37 meseca (od 0,03 do 37,8), pri čemer je bilo 66,0 % bolnikov izpostavljenih najmanj šest mesecev.
English: 1 vial of powder
Slovenian: 1 viala s praškom
English: If you forget to use Signifor
Slovenian: Če ste pozabili uporabiti zdravilo Signifor
English: If you have been told to use two needles, you should use the long thick blunt one for this step.
Slovenian: Če so vam naročili, da uporabljate dve igli, morate v tem koraku uporabiti dolgo, debelo in topo.
English: The mean age was 35.8 years, and the majority of patients were female (78.8%).
Slovenian: Povprečna starost bolnikov je bila 35,8 leta, večina jih je bila ženskega spola (78,8 %).
English: Insert the needle fully into the left or right gluteus at a 90° angle to the skin.
Slovenian: Iglo zabodite do konca v levi ali desni gluteus pod kotom 90°.
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.
Slovenian: V preučevanem starostnem okviru od 18 do 73 let je mogoče predvidevati, da bo površina pod krivuljo v stanju dinamičnega ravnovesja za en odmerni interval 12 ur (AUCss) v okviru od 86 % do 111 % vrednosti pri tipičnem bolniku v starosti 41 let.
English: To avoid sedimentation, you may gently shake the syringe to maintain a uniform suspension.
Slovenian: Da bi preprečili usedanje vsebine, lahko brizgo nežno stresate, tako da ostane suspenzija enotna.
English: This medicine comes in an ampoule, i.e. a small glass container.
Slovenian: To zdravilo je na voljo v ampuli, to je majhen steklen vsebnik.
English: If you are not sure about giving yourself the injection or if you have any questions, please ask your doctor or nurse for help.
Slovenian: Če niste prepričani, da si lahko sami injicirate zdravilo ali če imate kakršnakoli vprašanja, se za pomoč obrnite na svojega zdravnika ali medicinsko sestro.
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.
Slovenian: Adenom povzroči, da v telesu nastaja preveč hormonov, ki uravnavajo rast tkiv, organov in kosti, zato se kosti in tkiva povečajo, zlasti v dlaneh in stopalih.
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.
Slovenian: Podobno kot naravni peptidni hormoni somatostatin-14 in somatostatin-28 (ki ju imenujemo tudi sproščanje somatotropina zavirajoči hormon [angl. somatotropin release inhibiting factor, SRIF]) in drugi analogi somatostatina tudi pasireotid izraža svojo farmakološko aktivnost z vezavo na receptorje za somatostatin.
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.
Slovenian: - Če dojite, se posvetujte z zdravnikom, preden začnete jemati to zdravilo, saj ni znano, ali zdravilo Signifor prehaja v materino mleko.
English: Follow the instructions below carefully to ensure proper reconstitution of Signifor powder and solvent for suspension for injection before deep intramuscular injection.
Slovenian: Natančno upoštevajte spodnja navodila, da boste zdravilo Signifor prašek in vehikel za suspenzijo za injiciranje pravilno rekonstituirali pred dajanjem z globoko intramuskularno injekcijo.
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.
Slovenian: Naslednji odmerek nato načrtujte 4 tedne po injiciranju odmerka, tako da boste spet vzpostavili normalni razpored jemanja enega odmerka na 4 tedne.
English: In healthy volunteers, pasireotide is rapidly absorbed and peak plasma concentration is reached within 0.25-0.5 h. Cmax and AUC are approximately dose-proportional following administration of single and multiple doses.
Slovenian: Pri zdravih prostovoljcih se pasireotid hitro absorbira in doseže najvišjo koncentracijo v plazmi v 0,25-0,5 h. Cmax in AUC sta približno sorazmerna višini odmerka, in sicer po aplikaciji enkratnega ali večkratnih odmerkov.
English: Population pharmacokinetic analyses of Signifor suggest that race and gender do not influence pharmacokinetic parameters.
Slovenian: Analiza populacijske farmakokinetike zdravila Signifor kaže, da rasa in spol ne vplivata na farmakokinetične parametre.
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.
Slovenian: Pri osebah z zmerno oziroma s hudo okvaro jeter je bila AUCinf povečana za 60 % oziroma za 79 %, Cmax zvišana za 67 % oziroma za 69 %, očistek CL/F pa je bil znižan za 37 % oziroma za 44 %.
English: Pasireotide 0.9 mg twice daily % change (n)
Slovenian: pasireotid 0,9 mg dvakrat na dan odstotna sprememba (n)
English: Patients who have not responded to Signifor after two months of treatment should be considered for discontinuation.
Slovenian: Pri bolnikih, pri katerih po dveh mesecih ne pride do odziva na zdravilo Signifor, je treba razmisliti o prekinitvi zdravljenja.
English: • After adding the solvent, shake the vial moderately for a minimum of 30 seconds until a uniform suspension is formed.
Slovenian: • Po dodajanju vehikla vialo zmerno stresajte najmanj 30 sekund, dokler ne nastane enotna suspenzija.
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%).
Slovenian: Rdečica obraza se je izboljšala pri 43,5 % (47/108) bolnikov, pri več kot tretjini bolnikov je prišlo do izboljšanja glede supraklavikularnih maščobnih blazinic (34,3 %) in maščobnih blazinic na hrbtu (34,6 %).
English: The reconstituted Signifor is now ready for immediate administration.
Slovenian: Rekonstituirano zdravilo Signifor je zdaj pripravljeno za takojšnje injiciranje.
English: Improvements were observed in both dose groups for CushingQoL and the Mental Component Summary (MCS) of SF-12v2, but not for the Physical Component Summary (PCS) of SF-12v2.
Slovenian: Izboljšanja so opazili v obeh odmernih skupinah in sicer pri rezultatih vprašalnika CushingQoL in pri skupni oceni duševne komponente (angl. Mental Component Summary, MCS) vprašalnika SF-12v2, ne pa pri rezultatih skupne ocene fizične komponente (angl. Physical Component Summary, PCS) vprašalnika SF-12v2.
English: Slowly depress the plunger until the syringe is empty.
Slovenian: Počasi potiskajte bat navzdol, dokler brizga ni prazna.
English: Monitoring of liver function is recommended prior to treatment with pasireotide and after one, two, four, eight and twelve weeks during treatment.
Slovenian: Jetrno funkcijo je priporočeno spremljati pred začetkom zdravljenja s pasireotidom in en, dva, štiri, osem ter dvanajst tednov po začetku zdravljenja z njim.
English: If no clinical benefit is observed, the patient should be considered for discontinuation.
Slovenian: Če pri bolniku ni opaziti kliničnih koristi, je treba razmisliti o ukinitvi zdravljenja.
English: What Signifor is and what it is used for What you need to know before you use Signifor How to use Signifor
Slovenian: Kaj je zdravilo Signifor in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Signifor Kako uporabljati zdravilo Signifor Možni neželeni učinki
English: OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Slovenian: ŠKATLA ZA ZUNANJE PAKIRANJE V SKUPNEM PAKIRANJU (VKLJUČNO Z “BLUE BOX” PODATKI)