FrancophonIA/ELRC3.0 huggingface dataset:
English: For Dupuytren's disease, Xiapex breaks down the collagen forming the cord and thereby releasing the contracture completely or partly and enabling your finger(s) to be straighter.
Croatian: Kod Dupuytrenove bolesti Xiapex razgrađuje kolagen koji tvori tračak te na taj način dovodi do potpunog ili djelomičnog popuštanja kontrakture i omogućuje Vam jače ispružanje prsta (prstiju).
English: The double-blind study population comprised 832 male patients of whom 551 patients received Xiapex and 281 received placebo.
Croatian: Populacija u dvostruko slijepim ispitivanjima sastojala se od 832 muška bolesnika od kojih je 551 bolesnik primio Xiapex, a 281 placebo.
English: If your cord to be treated is attached to the skin, you are at higher risk of the skin splitting or tearing during the finger extension procedure following the injection of Xiapex.
Croatian: Ako je tračak koji će se liječiti povezan s kožom, imate veći rizik od kidanja ili pucanja kože tijekom postupka ekstenzije prsta nakon injekcije Xiapexa.
English: Patients with Dupuytren's contractures that adhere to the skin may be at higher risk of skin lesions as a result of the pharmacological effect of Xiapex and the finger extension procedure on the skin overlying the targeted cord.
Croatian: Bolesnici s Dupuytrenovom kontrakturom koja se hvata za kožu mogu imati veći rizik od kožnih lezija koje nastaju kao posljedica farmakološkog učinka Xiapexa i postupka ekstenzije prsta na kožu iznad ciljnog tračka.
English: Tell your doctor if you are thinking about receiving or have previously received Xiapex to treat a condition known as Dupuytren's contracture.
Croatian: Recite svom liječniku ako razmišljate o primanju ili ste prethodno primili Xiapex za liječenje stanja poznatog kao Dupuytrenova kontraktura.
English: Parturition or postnatal development studies in animals were not conducted since human pharmacokinetic studies show that Xiapex levels are not quantifiable in the systemic circulation following injection into a Dupuytren's cord (see section 5.1).
Croatian: Ispitivanja utjecaja na rađanje ili postnatalni razvoj u životinja nisu provedena, budući da su farmakokinetička ispitivanja u ljudi pokazala da se koncentracije Xiapexa u sistemskoj cirkulaciji nakon injekcije u Dupuytrenov tračak ne mogu izmjeriti (vidjeti dio 5.1).
English: At baseline, the mean (SD) Female PDQ score was 4.7 (3.61) and 2.7 (3.06) at week 36, i.e. a change from baseline of -2.0.
Croatian: Srednja vrijednost (SD) bodova na upitniku PDQ za žene iznosila je 4,7 (3,61) na početku i 2,7 (3,06) u 36. tjednu, tj. promjena od početne vrijednosti za -2,0.
English: There were no clinically meaningful differences in the incidence of adverse events following treatment with Xiapex based on the severity of baseline erectile dysfunction or concomitant phosphodiesterase type 5 (PDE5) inhibitor use.
Croatian: Nije bilo klinički značajnih razlika u incidenciji štetnih događaja nakon liječenja Xiapexom s obzirom na težinu početne erektilne disfunkcije ili istovremenu primjenu inhibitora fosfodiesteraze 5 (PDE5).
English: Severe penile haematoma including severe injection site haematoma were reported with the frequency very common.
Croatian: Težak oblik hematoma penisa uključujući i težak oblik hematoma na mjestu injekcije zabilježen je vrlo često.
English: Figure 2: Three step injection of Xiapex into the cord.
Croatian: Slika 2: Injiciranje Xiapexa u tračak u tri koraka.
English: At five years after the initial injection of Xiapex the majority of subjects (>90%) were seropositive for anti-AUX-I and anti-AUX-II antibodies.
Croatian: Pet godina nakon prve injekcije lijeka Xiapex većina je ispitanika (> 90%) bila seropozitivna na anti-AUX-I i anti-AUX-II protutijela.
English: • For Peyronie's disease if the treatment of your plaque involves the tube (called the urethra) that your urine passes through.
Croatian: • za Peyronijevu bolest, ako bi liječenje plaka zahvatilo cijev kroz koju prolazi mokraća (naziva se uretra).
English: The syringe and needle used for reconstitution are thereafter removed and discarded.
Croatian: Štrcaljku i iglu uporabljene za rekonstituciju nakon upotrebe treba izvući i baciti.
English: Xiapex also demonstrated a clinically significant benefit compared to placebo in decreasing the degree of contracture and increasing both the range of motion from baseline for all joints treated (MP plus PIP, MP only, PIP only) and the subject global assessment of treatment satisfaction.
Croatian: Xiapex je također pokazao klinički značajnu korist u usporedbi s placebom u smanjivanju stupnja kontrakture i povećanju opsega pokreta u odnosu na početno stanje svih liječenih zglobova (MP plus PIP, samo MP, samo PIP) i opće procjene ispitanika zadovoljstvom liječenja.
English: • 0.39 ml of solvent for the penile plaque in Peyronie's disease e) Inject the diluent slowly into the sides of the vial containing the lyophilized powder of Xiapex.
Croatian: • 0,39 ml otapala za plak u penisu kod Peyronijeve bolesti e) Polagano ubrizgajte otapalo niz stijenku bočice koja sadrži liofilizirani prašak Xiapex.
English: If more than one plaque is present, only the plaque causing the curvature deformity should be injected.
Croatian: Ako postoji više plakova, treba injicirati samo u onaj koji uzrokuje deformirajuću zakrivljenost.
English: • penis size reduced
Croatian: • smanjenje veličine penisa
English: Your doctor may recommend you perform a series of finger flexion and extension exercises several times a day for several months.
Croatian: Liječnik Vam može preporučiti niz vježbi savijanja i ispružanja prsta koje trebate raditi nekoliko puta na dan tijekom nekoliko mjeseci.
English: • Perform a series of finger flexion and extension exercises several times a day for several months.
Croatian: • nekoliko puta dnevno izvode seriju vježbi fleksije i ekstenzije prsta tijekom nekoliko mjeseci.
English: Signs or symptoms that may reflect serious injury to the penis should be promptly evaluated in order to assess for corporal rupture or severe penile haematoma, which may require surgical intervention.
Croatian: Znakove ili simptome koji mogu ukazivati na ozbiljnu ozljedu penisa treba procijeniti što prije kako bi se otkrila ruptura korpusa ili težak oblik hematoma penisa, koji mogu zahtijevati kiruršku intervenciju.
English: During clinical studies, blood samples from patients with Dupuytren's contracture and Peyronie's disease were tested at multiple time points for antibodies to the protein components of the medicinal product (AUX-I and AUX-II).
Croatian: Tijekom kliničkih ispitivanja, uzorci krvi bolesnika s Dupuytrenovom kontrakturom i Peyronijevom bolešću bili su testirani na protutijela na proteinske sastavnice ovog lijeka (AUX-I i AUX-II) više puta.
English: a Metacarpophalangeal joint; b Proximal interphalangeal joint; c 2 primary joints were excluded from the efficacy analysis (1 joint from the placebo group was not evaluated and 1 joint from the Xiapex treated group had a baseline contracture of 0 degrees before treatment).
Croatian: a Metakarpofalangealni zglob; b Proksimalni interfalangealni zglob; c 2 primarna zgloba bila su isključena iz analize djelotvornosti (1 zglob iz skupine koja je primala placebo nije bio procijenjen i 1 zglob iz skupine liječene Xiapexom imao je početnu kontrakturu od 0 stupnjeva prije liječenja).
English: • Wear the splint at bedtime for up to 4 months.
Croatian: • Da nose udlagu tijekom spavanja do 4 mjeseca.
English: All Joints p-value
Croatian: Svi zglobovi p-vrijednost
English: Withdraw the needle slowly so as to deposit the full dose along the needle track within the plaque.
Croatian: Polako izvlačite iglu tako da injicirate čitavu dozu duž puta koji igla prijeđe unutar plaka.
English: Clinical success (a reduction of contracture to ≤5° within 30 days) after two concurrent injections of Xiapex (one per joint) in the same hand was achieved for the majority of MP joints (64.6%) compared with 28.6% of PIP joints following a single injection per affected joint.
Croatian: Klinički uspjeh (smanjenje kontrakture na ≤5° unutar 30 dana) nakon dvije istovremeno primijenjene injekcije Xiapexa (jedna po zglobu) u istu šaku postignut je u većine MP zglobova (64,6%) u usporedbi s 28.6% PIP zglobova nakon jedne injekcije po zahvaćenom zglobu.
English: In addition, based on the review of post marketing case reports of penile fracture in patients with Peyronie's disease, the PRAC considers that the product information for Xiapex should be updated to include a new wording for section 4.4 of the SmPC and section 2 of the PIL to increase the minimum time span between injection and resumption of sexual activity to at least 4 weeks and to be cautious when resuming sexual activity.
Croatian: Povrh toga, na temelju pregleda prikaza slučajeva iz razdoblja nakon stavljanja lijeka u promet o prijelomu penisa u bolesnika s Peyronijevom bolešću, PRAC smatra da je potrebno ažurirati informacije o lijeku za Xiapex kako bi uključile novi opis u dijelu 4.4 Sažetka opisa svojstava lijeka i u dijelu 2 Upute o lijeku na način da se poveća minimalno razdoblje između injekcije i nastavka seksualne aktivnosti na najmanje 4 tjedna te navede da je potreban oprez kod nastavka seksualne aktivnosti.
English: Post-treatment surgery The impact of treatment with Xiapex on subsequent surgery, if needed, is not known.
Croatian: Nije poznat učinak liječenja Xiapexom na naknadno operativno liječenje, ako bude potrebno.
English: Xiapex should be injected into the target plaque when the penis is in a flaccid state.
Croatian: Xiapex je potrebno injicirati u ciljni plak dok je penis u opuštenom stanju.
English: Avoid having the needle tip pass completely through the cord to help minimise the potential for injection of Xiapex into tissues other than the cord.
Croatian: Pazite da vrškom igle potpuno ne probijete tračak kako biste minimalizirali mogućnost da injekciju Xiapexa date u neko drugo tkivo umjesto tračka.
English: Severe allergic reactions can happen in patients who receive Xiapex, because it contains proteins foreign to the human body.
Croatian: U bolesnika koji prime Xiapex može doći do teških alergijskih reakcija jer sadrži protein stran ljudskom tijelu.
English: Recurrence was assessed in successfully treated joints (i.e., subjects had a reduction in contracture to 5° or less at the Day 30 evaluation after the last injection of Xiapex in a previous study) and was defined as an increase in joint contracture by at least 20° in the presence of a palpable cord, or the joint underwent medical or surgical intervention primarily to correct a new or worsening Dupuytren's contracture in that joint.
Croatian: Recidiv kontrakture bio je procijenjen na uspješno liječenim zglobovima (tj. ispitanicima koji su postigli smanjenje kontrakture na 5° ili manje na procjeni 30. dana nakon posljednje injekcije Xiapexa u prethodnom ispitivanju) i bio je definiran kao povećanje kontrakture zgloba za najmanje 20° u prisutnosti opipljivog tračka ili podvrgavanje zgloba medicinskom ili kirurškom zahvatu prvenstveno zato da bi se ispravila nova Dupuytrenova kontraktura ili njeno pogoršanje na tom zglobu.
English: Injections and finger extension procedures may be administered up to 3 times per cord at approximately 4-week intervals.
Croatian: Injekcije i postupak ekstenzije prsta mogu se ponoviti do 3 puta po tračku u razmacima od približno 4 tjedna.
English: Injection procedure
Croatian: Postupak injiciranja
English: Injection site reactions were very common, occurring in the vast majority of patients, were mostly mild to moderate in severity and generally subsided within 1-2 weeks post injection.
Croatian: Reakcije na mjestu injekcije, koje su bile vrlo česte i nastale su u goleme većine bolesnika, uglavnom su bile blage do umjerene težine i općenito su se povlačile u roku od 1-2 tjedna nakon injekcije.
English: Xiapex demonstrated a clinically significant benefit compared to placebo in the proportion of patients achieving the primary endpoint of a reduction in the contracture of all joints treated to 5° or less, approximately 4 weeks after the last injection (MP plus PIP, MP only, PIP only).
Croatian: Xiapex je pokazao klinički značajnu korist u usporedbi s placebom u jednom postotku bolesnika koji su postigli primarni ishod smanjenja kontrakture svih liječenih zglobova na 5° ili manje, približno 4 tjedna nakon posljednje injekcije (MP plus PIP, samo MP, samo PIP).
English: Xiapex is a lyophilized product for parenteral administration containing collagenase clostridium histolyticum which is comprised of two collagenases in a defined mass ratio.
Croatian: Xiapex je liofilizirani lijek za parenteralnu primjenu koji sadrži kolagenazu clostridium histolyticum koja se sastoji od dvije kolagenaze u definiranom masenom omjeru.
English: a A joint was considered in an interval if the duration of assessment falls in the interval.
Croatian: a Zglob je ubrojen u pojedino razdoblje ako je trajanje procjene padalo u to razdoblje.
English: • shortness of breath, hyperventilation
Croatian: • nedostatak zraka (zaduha), hiperventilacija
English: The active substance in Xiapex is collagenase clostridium histolyticum, and this collagenase is produced using the microorganism Clostridium histolyticum.
Croatian: Djelatna tvar u Xiapexu je kolagenaza clostridium histolyticum, a ta se kolagenaza proizvodi pomoću mikroorganizma Clostridium histolyticum.
English: • skin wound, blood blister
Croatian: • rana na koži, krvavi mjehur
English: This medicine must only be injected into the collagen cord in your hand by your doctor.
Croatian: Ovaj lijek smije ubrizgati samo Vaš liječnik i to samo u kolagenski tračak u Vašoj ruci.
English: Following each of two intralesional administrations, separated by 24 hours, of Xiapex 0.58 mg into the penile plaque of 19 patients with Peyronie's disease, plasma levels of AUX-I and AUX-II in patients with quantifiable levels (82% and 40% for AUX-I and AUX-II, respectively) were minimal and shortlived.
Croatian: Nakon svake od ukupno dvije intralezijske primjene 0,58 mg Xiapexa u plak penisa u razmaku od 24 sata u 19 bolesnika s Peyronijevom bolešću, razine AUX-I i AUX-II u plazmi bolesnika s mjerljivim razinama (82% za AUX-I i 40% za AUX-II) bile su minimalne i kratkotrajne.
English: There are no known interactions with concomitant use of medicines for erectile dysfunction and Xiapex treatment.
Croatian: Nema poznatih interakcija pri primjeni lijekova za erektilnu disfunkciju istovremeno s liječenjem Xiapexom.
English: Baseline disease characteristics of patientsa with Peyronie's Disease (PD)
Croatian: Početna obilježja bolesnikaa s Peyronijevom bolešću (PB)
English: • Not perform strenuous activity with the injected hand until advised to do so.
Croatian: • ne obavljaju teške aktivnosti injiciranom šakom dok im se ne savjetuje drugačije.
English: • collection of blood outside the blood vessels
Croatian: • nakupljanje krvi izvan krvnih žila
English: Treatment of two concurrent injections
Croatian: Liječenje istovremenom primjenom dvije injekcije
English: • increased liver enzymes
Croatian: • povišeni jetreni enzimi
English: Diagnostic imaging is recommended after manipulation if finger deformity, pain or increased swelling develops (see also section 4.8).
Croatian: Ako se nakon ekstenzije razvije deformacija, bol ili pojačano oticanje prsta, preporučuje se dijagnostičko oslikavanje (vidjeti i dio 4.8).
English: Following this disruption of the plaque, penile curvature deformity and patient bother caused by Peyronie's disease are reduced.
Croatian: Nakon razgradnje plaka smanjena je deformirajuća zakrivljenost penisa i bolesnikove tegobe uzrokovane Peyronijevom bolešću.
English: The study inclusion and exclusion criteria as well as the treatment schedule and the co-primary efficacy endpoints were the same as in the pivotal AUX-CC-803 and AUX-CC-804 studies.
Croatian: Kriteriji uključenja i isključenja u tom ispitivanju, kao i raspored liječenja i koprimarni ishodi djelotvornosti bili su isti kao i u pivotalnim ispitivanjima AUX-CC-803 i AUX-CC-804.
English: Call your doctor right away if you experience any of the symptoms of penile fracture or serious injury to your penis listed above, as this may require surgical intervention.
Croatian: Odmah se javite svom liječniku ako Vam se javi bilo koji od gore nabrojenih simptoma prijeloma penisa ili ozbiljne ozljede penisa, jer to može zahtijevati kiruršku intervenciju.
English: If the disease has resulted in multiple contractures, additional cords may be treated at other treatment visits approximately 4 weeks apart, as determined by your doctor.
Croatian: Ako je bolest dovela do nastanka višestrukih kontraktura, dodatni tračci mogu se liječiti prilikom drugih terapijskih posjeta u razmaku od približno 4 tjedna, kako odredi Vaš liječnik.
English: Therefore, Xiapex must be injected only into the Peyronie's plaque and care should be taken to avoid injecting into the urethra, nerves, blood vessels, corpora cavernosa or other collagen-containing structures of the penis.
Croatian: Xiapex mora injicirati samo u Peyronijev plak i treba paziti da ga se ne bi injiciralo u uretru, živce, krvne žile, kavernozna tijela ili druge strukture penisa koje sadrže kolagen.
English: Administration of regional anaesthesia (penile block) or topical anaesthesia could be applied prior to Xiapex injection when desired.
Croatian: Po želji, može se primijeniti regionalna (penilni blok) ili topikalna anestezija prije injekcije Xiapexa.
English: A penile modelling procedure was performed on patients at the study site 1 to 3 days after the second injection of the cycle.
Croatian: Postupak modeliranja penisa proveden je bolesnicima u ispitivačkom centru 1 do 3 dana nakon druge injekcije u ciklusu.
English: h) Upon complete withdrawal of the needle, apply gentle pressure at the injection site.
Croatian: h) Nakon završenog izvlačenja igle, nježno pritisnite mjesto injekcije.
English: c) Use only the supplied diluent for reconstitution.
Croatian: c) Upotrijebite samo priloženo otapalo za rekonstituciju.
English: Instructions on how to gently straighten your penis Gently straighten your penis one time a day.
Croatian: Upute za nježno istezanje penisa Nježno istegnite svoj penis 3 puta na dan.
English: Please consult a doctor immediately if you experience any signs or symptoms of a serious allergic reaction, e.g., wide spread redness or rash, swelling, tightness in the throat or difficulty breathing.
Croatian: Molimo odmah potražite savjet liječnika ako osjetite ikakve znakove ili simptome ozbiljne alergijske reakcije, npr. prošireno crvenilo ili osip, otečenost, stezanje u grlu ili otežano disanje.
English: If injecting into a cord affecting the PIP joint of the fifth (little) finger, care must be taken to inject as close to the palmar digital crease as possible and not to insert more than 2 mm to 3 mm in depth.
Croatian: Ako se injekcija daje u tračak koji zahvaća PIP zglob petog (malog) prsta, treba paziti da se ubrizga što bliže palmarnodigitalnoj brazdi i ne uvede dublje od 2 mm do 3 mm.
English: Xiapex is supplied in a pack containing 1 vial of Xiapex powder and 1 vial of solvent.
Croatian: Xiapex se isporučuje u pakiranju koje sadrži 1 bočicu praška Xiapex i 1 bočicu otapala.
English: At a follow-up visit 1 to 3 days after the second injection of each treatment cycle, perform a penile modelling procedure (as described below) on the flaccid penis to stretch and elongate the plaque that Xiapex has disrupted:
Croatian: Na kontrolnom posjetu 1 do 3 dana nakon druge injekcije svakog ciklusa liječenja, provedite postupak modeliranja penisa (kako je opisano niže) na opuštenom penisu kako bi se plak razgrađen Xiapexom rastegnuo i produljio:
English: If the disease has resulted in multiple contractures, additional cords may be treated at other treatment visits approximately 4 weeks apart.
Croatian: Ako je bolest dovela do višestrukih kontraktura, dodatni tračci mogu se liječiti prilikom drugih terapijskih posjeta u razmaku od približno 4 tjedna.
English: A higher incidence of skin laceration may be attributable to more vigorous finger extension procedures in patients after receiving anaesthesia to the hand.
Croatian: Viša incidencija laceracije kože može se pripisati žustrijim postupcima ekstenzije prsta u bolesnika nakon što su dobili anesteziju u šaku.
English: • the change from baseline to Week 52 in the Bother domain of the Peyronie's Disease
Croatian: • promjena od početka ispitivanja do 52. tjedna u dijelu "tegobe" upitnika za Peyronijevu bolest
English: • With one hand, hold the tip of your penis with your fingers.
Croatian: • Prstima jedne ruke držite vrh penisa.
English: Treatment of Peyronie's plaques that involve the penile urethra due to potential risk to this structure.
Croatian: Liječenje Peyronijevog plaka koji zahvaća uretru, zbog mogućeg rizika za uretru.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton containing 1 vial of powder and 1 vial of solvent
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija koja sadrži 1 bočicu praška i 1 bočicu otapala
English: Your doctor will ask you to return approximately 24-72 hours after your injection to attempt to extend your finger to straighten it.
Croatian: Liječnik će Vam reći da se vratite približno 24-72 sata nakon injekcije kako bi Vam pokušao ispraviti prst, tako da ga možete ispružiti.
English: Blood glucose increased Blood pressure systolic increased
Croatian: Pretrage povišena glukoza u krvi povišen sistolički krvni tlak povišena tjelesna temperatura
English: Primary efficacy endpoint was fixed flexion contracture in the treated joint pair subgroup.
Croatian: Primarni ishod djelotvornosti bio je fiksna fleksijska kontraktura u podskupini s liječenim parom zglobova.
English: A finger extension procedure was performed if needed, approximately 24 hours after injection to facilitate disruption of the cord.
Croatian: Postupak ekstenzije prsta napravljen je po potrebi, približno 24 sata nakon injekcije, kako bi se olakšalo razbijanje tračka.
English: Taking into account the plausibility of the mechanism of collagenase clostridium histolyticum and the subsequent manipulation procedure in patients with Dupuytren's contracture, the PRAC considers that the product information for Xiapex should be updated to include a warning with regards to finger necrosis resulting in some cases in finger amputation and a warning with regards to finger fracture should be included in section 4.4 of the SmPC.
Croatian: Uzimajući u obzir vjerojatnost mehanizma djelovanja kolagenaze clostridium histolyticum i naknadni postupak ekstenzije prsta u bolesnika s Dupuytrenovom kontrakturom, PRAC smatra da je potrebno ažurirati informacije o lijeku za Xiapex kako bi u dijelu 4.4 Sažetka opisa svojstava lijeka uključile upozorenje o nekrozi prsta koja u nekim slučajevima rezultira amputacijom prsta, te upozorenje o prijelomu prsta.
English: If two cords of affected joints on the same hand are to be treated during a treatment visit, separate vials and syringes should be used for each reconstitution and injection.
Croatian: Ako će se tijekom terapijskog posjeta liječiti dva tračka zahvaćenih zglobova na istoj šaci, za svaku rekonstituciju i injekciju treba uporabiti zasebne bočice i štrcaljke.
English: Sodium injected per joint in the treatment of Dupuytren's contracture: Metacarpophalangeal (MP) joints: 0.9 mg.
Croatian: Natrij ubrizgan po zglobu kod liječenja Dupuytrenove kontrakture: Metakarpofalangealni (MP) zglobovi: 0,9 mg.
English: The Bother domain score is a composite of the following patient-reported items: concern about erection pain, erection appearance, and the impact of Peyronie's disease on intercourse and on frequency of intercourse.
Croatian: U dijelu "tegobe" boduju se sljedeće sastavnice koje bolesnik zabilježi: zabrinutost zbog bolne erekcije, pojava erekcije i utjecaj Peyronijeve bolesti na snošaj i na učestalost snošaja.
English: • 0.25 ml of reconstituted Xiapex for cords affecting a MP joint or • 0.20 ml of reconstituted Xiapex for cords affecting a PIP joint.
Croatian: • 0,25 ml rekonstituiranog Xiapexa u tračke koji zahvaćaju MP zglob ili • 0,20 ml rekonstituiranog Xiapex u tračke koji zahvaćaju PIP zglob.