FrancophonIA/ELRC3.0 huggingface dataset:
English: In the Peyronie's disease clinical studies, at 6 weeks after the first treatment cycle of Xiapex, approximately 75% of patients had antibodies against AUX-I and approximately 55% of patients had antibodies against AUX-II.
Croatian: U kliničkim ispitivanjima u Peyronijevoj bolesti 6 tjedana nakon prvog ciklusa liječenja Xiapexom, približno 75% bolesnika imalo je protutijela protiv AUX-I i približno 55% bolesnika imalo je protutijela protiv AUX-II.
English: The target plaque is used as a fulcrum point with both hands, to firmly apply a steady pressure to elongate and stretch the plaque.
Croatian: Ciljni plak služi kao uporišna točka za obje ruke, kako bi se čvrsto primijenio ravnomjeran pritisak te produljio i rastegnuo plak.
English: In each treatment cycle, two injections of Xiapex 0.58 mg or two injections of placebo were administered 1 to 3 days apart.
Croatian: svakom ciklusu liječenja primijenjene su dvije injekcije s 0,58 mg Xiapexa ili placeba u razmaku od 1 do 3 dana.
English: Xiapex must be used with caution in patients with coagulation disorders or those taking anticoagulants.
Croatian: Primjena u bolesnika s poremećajima koagulacije Xiapex se mora primjenjivati s oprezom u bolesnika s poremećajima koagulacije i onih koji uzimaju antikoagulanse.
English: Tables 11-12 provide the results of the co-primary efficacy endpoints measured in the open label phase 3 study AUX-CC-806.
Croatian: Tablice 11-12 prikazuju rezultate koprimarnih ishoda djelotvornosti mjerenih u ispitivanju faze 3 otvorenog tipa AUX-CC-806.
English: Tabulated list of adverse reactions Table 2 presents adverse reactions listed by system organ class and frequency categories, using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to
Croatian: Tablica 2 prikazuje nuspojave prema klasifikaciji organskih sustava i kategorijama učestalosti sukladno sljedećoj konvenciji: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i
English: Neutralizing antibodies to AUX-I or AUX-II, were detected in 60% and 51.8%, respectively, of patients tested.
Croatian: otkrivena su u 60% odnosno 51,8% testiranih bolesnika.
English: Injection of Xiapex into collagen containing structures may result in damage to those structures, and possible permanent injury such as tendon rupture or ligament damage.
Croatian: Injekcija Xiapexa u strukture koje sadrže kolagen može rezultirati oštećenjem tih struktura i mogućom trajnom ozljedom, kao što je ruptura tetive ili oštećenje ligamenta.
English: • To promptly contact their doctor if there is evidence of infection (e.g., fever, chills, increasing redness or oedema) or trouble bending the finger after the swelling goes down (symptoms of tendon rupture).
Croatian: • Da odmah posjete liječnika ako se pojave znakovi infekcije (npr., vrućica, zimica, pojačano crvenilo ili edem) ili ako je savijanje prsta otežano nakon što se oteklina povuče
English: There is no experience in the use of Xiapex in pregnant women therefore the use of Xiapex is not recommended in pregnancy, and treatment should be postponed until after pregnancy.
Croatian: Nema iskustva s primjenom Xiapexa u trudnica pa se stoga ne preporučuje primjena Xiapexa u trudnoći, a liječenje treba odgoditi do razdoblja nakon trudnoće.
English: It is not known whether collagenase clostridium histolyticum is excreted in human milk.
Croatian: Nije poznato izlučuje li se kolagenaza clostridium histolyticum u majčino mlijeko.
English: This medicine must only be injected into the plaque in your penis by your doctor.
Croatian: Ovaj lijek smije ubrizgati samo Vaš liječnik i to samo u plak u Vašem penisu.
English: Special penile conditions/diseases not studied in clinical trials Xiapex treatment in patients having a calcified plaque that could have interfered with the injection technique, chordee in the presence or absence of hypospadias, thrombosis of the dorsal penile artery and/or vein, infiltration by a benign or malignant mass resulting in penile curvature, infiltration by an infectious agent, such as in lymphogranuloma venereum, ventral curvature from any cause and isolated hourglass deformity of the penis has not been studied and treatment in these patients should be avoided.
Croatian: U bolesnika s kalcificiranim plakom zbog kojeg se tehnika injiciranja ne bi mogla pravilno izvesti, bolesnika s tračcima uz hipospadiju ili bez nje, bolesnika s trombozom dorzalne arterije i/ili vene penisa, bolesnika u kojih je zakrivljenost penisa uzrokovana infiltracijom benignom ili malignom tumorskom masom, bolesnika s infektivnom infiltracijom kao kod lymphogranuloma venereum, bolesnika s ventralnom zakrivljenošću bilo kojeg uzroka i bolesnika s izoliranim deformitetom penisa u obliku pješčanog sata liječenje Xiapexom nije ispitivano i liječenje takvih bolesnika treba izbjegavati.
English: Powder: Contains sucrose, trometamol, hydrochloric acid Solvent: Contains calcium chloride dihydrate, sodium chloride, water for injection
Croatian: Prašak: sadrži saharozu, trometamol, kloridnu kiselinu Otapalo: sadrži kalcijev klorid dihidrat, natrijev klorid, vodu za injekcije
English: No more than 3 attempts per affected joint are recommended to disrupt a cord.
Croatian: Ne preporučuje se više od 3 pokušaja po zahvaćenom zglobu za raskidanje tračka.
English: You should gently stretch your penis 3 times a day for 6 weeks after each treatment cycle.
Croatian: Trebate nježno istezati penis 3 puta dnevno tijekom 6 tjedana nakon svakog ciklusa liječenja.
English: There is no relevant use of Xiapex in the paediatric population aged 0-18 years for the treatment of Dupuytren's contracture.
Croatian: Nema relevantne primjene Xiapexa u pedijatrijskoj populaciji u dobi od 0 do 18 godina za liječenje Dupuytrenove kontrakture.
English: The volume of solvent required and the volume of reconstituted Xiapex to be administered into the Dupuytren's cord differs depending on the type of joint being treated (for the reconstitution instructions, see section 6.6, Table 14).
Croatian: Volumen potrebnog otapala i volumen rekonstituiranog Xiapexa koji će se primijeniti u Dupuytrenov tračak ovisi o vrsti zgloba koji se liječi (za upute o rekonstituciji vidjeti dio 6.6, tablicu 14).
English: A study AUX-CC-862 was conducted in patients with Dupuytren's contracture who had recurrence of contracture in a joint that was effectively treated with Xiapex in a previous clinical study.
Croatian: Ispitivanje AUX-CC-862 provedeno je u bolesnika s Dupuytrenovom kontrakturom u kojih je došlo do recidiva kontrakture u zglobu koji je bio uspješno liječen Xiapexom u prethodnom kliničkom ispitivanju.
English: Xiapex must be reconstituted with the solvent provided and to the appropriate volume prior to intralesional injection (see section 6.6).
Croatian: Xiapex se prije intralezijske injekcije mora rekonstituirati priloženim otapalom i do odgovarajućeg volumena (vidjeti dio 6.6).
English: In the two Phase 3 double-blind placebo-controlled studies, most adverse reactions were local events of the penis and groin and the majority of these events were of mild or moderate severity, and most (79%) resolved within 14 days of the injection.
Croatian: U ta dva dvostruko slijepa, placebom kontrolirana ispitivanja faze 3, većina nuspojava bile su lokalne pojave u području penisa i prepona, većinom su bile blage ili umjerene težine i većina (79%) ih se povukla unutar 14 dana od injekcije.
English: Patients develop ADAs after repeated administration, the cross-reactivity of which versus endogenous MMPs involved in pregnancy and labour cannot be excluded.
Croatian: Bolesnici nakon ponovne primjene razvijaju protutijela na lijek, čija se ukrižena reaktivnost s endogenim matriksnim metaloproteinazama uključenima u trudnoću i porođaj ne može isključiti.
English: When injecting a cord affecting a PIP joint of the fifth finger, the needle insertion must not be more than 2 to 3 mm in depth and not more than 4 mm distal to the palmar digital crease.
Croatian: Kad se injicira u tračak koji zahvaća PIP zglob petog prsta ruke, igla se ne smije uvesti više od 2 do 3 mm u dubinu i ne više od 4 mm distalno od brazde korijena prsta.
English: The incidence of Xiapex-associated pruritus was similar after each injection regardless of the number of injections administered.
Croatian: Incidencija pojave svrbeža povezanog s primjenom Xiapexa bila je slična nakon svake injekcije, bez obzira na broj primijenjenih injekcija.
English: Again keeping the needle under the skin at all times, withdraw the needle tip from the cord and reposition it a third time proximal to the initial injection (approximately 2-3 mm) and inject the final portion of the dose into the cord (see Figure 2).
Croatian: Držeći iglu pod kožom cijelo vrijeme, ponovno izvucite vršak igle iz tračka i promijenite joj položaj treći put, proksimalno u odnosu na prvu injekciju (približno 2-3 mm) i injicirajte zadnji dio doze u tračak (vidjeti sliku 2).
English: • 0.39 ml of solvent for cords affecting a MP joint in Dupuytren's contracture • 0.31 ml of solvent for cords affecting a PIP joint in Dupuytren's contracture
Croatian: • 0,39 ml otapala za tračke koji zahvaćaju MP zglob kod Dupuytrenove kontrakture • 0,31 ml otapala za tračke koji zahvaćaju PIP zglob kod Dupuytrenove kontrakture
English: Other endpoints included ≥50% reduction from baseline in degree of contracture, percent change from baseline in degree of contracture, change from baseline in range of motion, subject global assessment of treatment satisfaction and physician global assessment of severity.
Croatian: Ostali ishodi uključivali su smanjenje stupnja kontrakture za ≥50% u odnosu na početni, postotak promjene u odnosu na početni stupanj kontrakture, promjenu opsega pokreta u odnosu na početni, opću procjenu zadovoljstva liječenjem ispitanika i liječničku opću procjenu težine stanja.
English: Mean age (years) (Min-Max)
Croatian: Srednja dob (godine) (min-maks.)
English: No formal medicinal product interaction studies with Xiapex have been performed.
Croatian: Nisu provedena ispitivanja interakcija lijekova za Xiapex.
English: This indicates the target area in the plaque for Xiapex deposition
Croatian: Ona označava ciljno područje u plaku za unos
English: • chronic pain
Croatian: • kronična bol
English: The cord affecting a selected primary joint received up to 3 injections of 0.58 mg of Xiapex or placebo.
Croatian: U tračak koji zahvaća određeni primarni zglob primijenilo se 3 injekcije od 0,58 mg Xiapexa ili placebo.
English: If, at that subsequent visit the contracted cord persists, an additional injection and finger extension procedure may be performed.
Croatian: Ako na tom posjetu kontraktura i dalje bude prisutna, može se dati dodatna injekcija i ponovno napraviti postupak ekstenzije prsta.
English: Following the finger extension procedure(s) and fitting patient with a splint (with treated joint in maximum extension), the patients should be instructed to:
Croatian: Nakon postup(a)ka ekstenzije prsta i postavljanja udlage (s liječenim zglobom u položaju maksimalne ekstenzije) bolesnicima je potrebno savjetovati da:
English: Absorption Following administration of either a single dose of 0.58 mg of Xiapex to 16 patients with Dupuytren's contracture, or two concurrent injections of 0.58 mg of Xiapex in the same hand in 12 patients with Dupuytren's contracture, no quantifiable levels of Xiapex were detected in plasma from 5 minutes to 30 days post injection.
Croatian: Nakon primjene bilo jedne doze od 0,58 mg Xiapexa u 16 bolesnika s Dupuytrenovom kontrakturom, bilo dvije istovremene injekcije Xiapexa u dozi od 0,58 mg u istu šaku u 12 bolesnika s Dupuytrenovom kontrakturom nisu otkrivene mjerljive razine Xiapexa u plazmi u razdoblju od 5 minuta do 30 dana nakon injekcije.
English: Dupuytren's contracture
Croatian: Dupuytrenova kontraktura
English: Baseline, mean (SD) Day 31, mean (SD) Change, mean (SD) % Change, mean (SD)
Croatian: Početno stanje, srednja vrijednost (SD) 31. dan, srednja vrijednost (SD) Promjena, srednja vrijednost (SD) % promjene, srednja vrijednost (SD)
English: This condition affects adult men, who have a ‘plaque' that can be felt and a curve to their erect penis.
Croatian: Ovo stanje se javlja u odraslih muškaraca koji imaju "plak" koji se može napipati i koji savija njihov penis.
English: Using a sterile syringe calibrated with 0.01 ml graduations, the appropriate amount of solvent supplied should be withdrawn in order to deliver as follows:
Croatian: Pomoću sterilne kalibrirane štrcaljke s oznakama na svakih 0,01 ml treba izvući odgovarajuću količinu priloženog otapala kako biste ga injicirali prema sljedećem:
English: Reduced peripheral circulation may be one contributing factor for finger necrosis.
Croatian: Faktor koji doprinosi nekrozi prstiju može biti smanjena periferna cirkulacija.
English: Patients were excluded if they had a ventral curvature deformity, an isolated hourglass deformity or a calcified plaque that could have interfered with the injection technique.
Croatian: Bolesnici koji su imali ventralnu deformirajuću zakrivljenost, izolirani deformitet u obliku pješčanog sata ili kalcificirani plak koji bi mogao ometati pravilno izvođenje tehnike injiciranja bili su isključeni.
English: • The other ingredients are sucrose, trometamol and hydrochloric acid 2.4% w/w (for pH
Croatian: Drugi sastojci su saharoza, trometamol i kloridna kiselina 2,4% m/m (za podešavanje pH).
English: Prior to each treatment cycle, identify the treatment area as follows:
Croatian: Utvrđivanje područja liječenja Prije svakog ciklusa liječenja, utvrdite područje liječenja na sljedeći način:
English: The symptoms of musculoskeletal syndrome could be joint or muscle pain, shoulder stiffness, hand swelling, fibrosis of the palms, and thickening or nodule forming of tendons.
Croatian: Simptomi mišićno-koštanog sindroma mogu biti bolnost zglobova ili mišića, ukočenost ramena, otečenost šake, fibroza dlanova i zadebljanje tetiva i stvaranje čvorića u tetivama.
English: Do not invert the vial or shake the solution.
Croatian: Nemojte preokretati bočicu niti tresti otopinu.
English: The vial containing the solution should not be inverted or shaken.
Croatian: Bočica s otopinom ne smije se preokretati ili tresti.
English: Xiapex is a powder and solvent for solution for injection.
Croatian: Xiapex je prašak i otapalo za otopinu za injekciju.
English: Wrap the patient's treated hand with a soft, bulky, gauze dressing.
Croatian: Povijte liječenu šaku bolesnika mekim, velikim povojem od gaze.
English: Discard the unused portion of the reconstituted solution and solvent after injection.
Croatian: 12. Bacite nepotrošeni dio rekonstituirane otopine i otapalo nakon davanja injekcije.
English: • If you are allergic to collagenase clostridium histolyticum or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na kolagenazu clostridium histolyticum ili neki drugi sastojak ovog lijeka
English: Therefore, use of Xiapex in patients who have received tetracycline antibiotics (e.g., doxycycline) within 14 days prior to receiving an injection of Xiapex is not recommended.
Croatian: Stoga se ne preporučuje primjena Xiapexa u bolesnika koji su primali tetraciklinske antibiotike (npr. doksiciklin) unutar 14 dana prije dobivanja injekcije Xiapexa.
English: Physician-rated change in contracture severity was reported as very much improved or much improved in 86% and 80% of the subjects in the Xiapex group compared to 3% and 5% of subjects in the placebo group for the CORD I and CORD II studies, respectively (p<0.001).
Croatian: Zabilježena promjena težine kontrakture prema ocjeni liječnika bila je jako poboljšana ili dosta poboljšana u 86% odnosno 80% ispitanika u skupini koja je primala Xiapex u usporedbi s 3% odnosno 5% ispitanika u skupini koja je primala placebo u ispitivanjima CORD I i CORD II (p<0,001).
English: At the follow-up visit approximately 24-72 hours after injection, determine if the contracture has resolved.
Croatian: Na kontrolnom posjetu približno 24-72 sata nakon injekcije utvrdite je li kontraktura nestala.
English: • Wearing gloves, grasp the plaque or indurated portion of the flaccid penis about 1 cm proximal and distal to the injection site.
Croatian: • Noseći rukavice uhvatite plak ili indurirani dio opuštenog penisa otprilike 1 cm proksimalno i distalno od mjesta injiciranja.
English: A phase 4, non-treatment, long-term follow-up study (AUX-CC-810) was undertaken to evaluate the efficacy and safety up to 5 years after the first injection of Xiapex in the pivotal 12-month doubleblind placebo-controlled phase 3 studies or in the 9-month open-label phase 3 studies.
Croatian: Provedeno je ispitivanje faze IV (AUX-CC-810) s dugoročnim praćenjem bez liječenja kako bi se procijenila djelotvornost i sigurnost u razdoblju do 5 godina nakon prve injekcije Xiapexa primijenjene u ključnim 12-mjesečnim, dvostruko slijepim, placebom kontroliranim ispitivanjima faze III ili u 9mjesečnim, otvorenim ispitivanjima faze III.
English: • small area of inflammation
Croatian: • malo područje upale
English: Table 2: Tabulated list of adverse reactions.
Croatian: Tablica 2: Tablični popis nuspojava.
English: Next, keeping the needle under the skin at all times, withdraw the needle tip from the cord and reposition it in a slightly more distal location (approximately 2-3 mm) to the initial injection in the cord and inject another one-third of the dose.
Croatian: Nadalje, držeći iglu pod kožom cijelo vrijeme, izvucite vršak igle iz tračka i promijenite joj položaj na malo distalniju lokaciju (približno 2-3 mm) u odnosu na prvu injekciju u tračak i ubrizgajte drugu trećinu doze.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Xiapex in all subsets of the paediatric population in the treatment of Peyronie's disease (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Xiapex u svim podskupinama pedijatrijske populacije u liječenju Peyronijeve bolesti (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: For cords affecting the PIP joint, perform the finger extension procedure when the MP joint is in the flexed position.
Croatian: Za tračke koji zahvaćaju PIP zglob, napravite postupak ekstenzije prsta kad je MP zglob u položaju fleksije.
English: • difficulty urinating or blood in the urine
Croatian: • otežano mokrenje ili krv u mokraći
English: • painful/increased urination
Croatian: • bolno/pojačano mokrenje
English: If cords of two affected joints in one finger were treated, perform the finger extension procedure on the cord affecting the MP joint before performing the procedure on the cord affecting the PIP joint.
Croatian: Ako su bili liječeni tračci dva zahvaćena zgloba na jednom prstu, provedite postupak ekstenzije prsta na tračku koji zahvaća MP zglob prije nego što provedete postupak na tračku koji zahvaća
English: Table 3 provides demographic and baseline characteristics for the study population and Tables 4-5 provide the results of the major efficacy endpoints measured in the 2 double-blind placebo-controlled studies CORD I (AUX-CC-857) and CORD II (AUX-CC-859).
Croatian: Tablica 3 prikazuje demografska obilježja ispitivane populacije i obilježja na početku ispitivanja, a tablice 4-5 donose rezultate glavnih ciljeva za djelotvornost mjerene u dva dvostruko slijepa, placebom kontrolirana ispitivanja CORD I (AUX-CC-857) i CORD II (AUX-CC-859).
English: Do not store, pool, or use any vials containing unused reconstituted solution or solvent.
Croatian: Nemojte čuvati, skupljati ili upotrebljavati bočice koje sadrže neiskorištenu rekonstituiranu otopinu ili otapalo.
English: Peyronie's disease This condition does not occur in females.
Croatian: Ovo stanje se ne pojavljuje u žena.
English: Only stretch your penis if your penis is not hard (erect).
Croatian: Istežite ga samo ako nije tvrd (u erekciji).
English: No new safety signals were identified among subjects who were retreated with Xiapex.
Croatian: Nisu uočeni novi sigurnosni signali u ispitanika koji su ponovno liječeni Xiapexom.
English: The efficacy and safety of Xiapex in patients receiving anticoagulant medicinal products other than up to 150 mg acetylsalicylic acid per day prior to Xiapex administration is not known.
Croatian: Nije poznata djelotvornost i sigurnost Xiapexa u bolesnika koji primaju neki drugi antikoagulans osim acetilsalicilne kiseline u dozi do 150 mg na dan prije primjene Xiapexa.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Xiapex in all subsets of the paediatric population in the treatment of Dupuytren's contracture (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Xiapex u svim podskupinama pedijatrijske populacije u liječenju Dupuytrenove kontrakture (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Store in a refrigerator at 2ºC-8ºC.
Croatian: Čuvati u hladnjaku na temperaturi od 2ºC do 8ºC.
English: You should gently straighten your penis 1 time a day for 6 weeks after each treatment cycle.
Croatian: Trebate nježno ispravljati penis 1 dnevno tijekom 6 tjedana nakon svakog ciklusa liječenja.
English: • Using the target plaque as a fulcrum point, use both hands to apply firm, steady pressure to elongate and stretch the plaque.
Croatian: • Koristeći ciljni plak kao uporišnu točku s obje ruke primijenite čvrst i ravnomjeran pritisak kako bi se plak produljio i rastegnuo.
English: Visually inspect the vial containing Xiapex.
Croatian: Vizualno pregledajte bočicu s Xiapexom.
English: If a cord contracture remains, a passive finger extension procedure will be performed in an attempt to disrupt the cord.
Croatian: Ako je kontraktura s tračkom i dalje prisutna, izvest će se postupak pasivne ekstenzije prsta kako bi se raskinulo tračak.
English: The incidence of skin laceration (29.1%) was higher for subjects treated with two concurrent injections of Xiapex in historically-controlled clinical study AUX-CC-867 compared with subjects treated with up to three single injections in the Phase 3 placebo-controlled pivotal studies in Dupuytren's contracture (CORD I and CORD II) (8.8%).
Croatian: Incidencija laceracije kože (29,1%) bila je viša u ispitanika koji su istovremeno primili dvije injekcije Xiapexa u ispitivanju AUX-CC-867 u kojem se koristila kontrolna skupina iz prošlosti u usporedbi s ispitanicima koji su primili do tri jednokratne injekcije u placebom kontroliranim ključnim ispitivanjima faze III (CORD I i CORD II) kod Dupuytrenove kontrakture (8,8%).
English: After needle placement, if there is any concern that the needle is in the flexor tendon, apply a small amount of passive motion at the distal interphalangeal (DIP) joint.
Croatian: Nakon što postavite iglu, ako Vas brine da je igla u tetivi fleksora, primjenom blagog pritiska pasivno pokrenite distalni interfalangealni (DIP) zglob.
English: Approximately 24-72 hours after injection, a finger extension procedure may be performed, as necessary, to facilitate cord disruption.
Croatian: Otprilike 24-72 sata nakon injekcije, po potrebi se može napraviti postupak ekstenzije prsta kako bi se olakšalo raskidanje tračka.
English: The reduction in the Bother domain score was numerically similar between patient groups stratified by degree of baseline curvature deformity (30 to 60 degrees and 61 to 90 degrees).
Croatian: Smanjenje bodova u dijelu "tegobe" bilo je numerički slično u skupinama bolesnika stratificiranih prema stupnju početne deformirajuće zakrivljenosti (30-60 stupnjeva i 61-90 stupnjeva).
English: The recommended dose of Xiapex is 0.58 mg per injection administered into a Peyronie's plaque.
Croatian: Preporučena doza Xiapexa je 0,58 mg po injekciji primijenjenoj u Peyronijev plak.
English: Grounds for the variation to the terms of the Marketing Authorisation
Croatian: Razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet