FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no experience in the use of Xiapex in breast-feeding women therefore the use of Xiapex is not recommended during breast-feeding.
Croatian: Nema iskustva s primjenom Xiapexa u dojilja pa se stoga ne preporučuje primjena Xiapexa tijekom dojenja.
English: Administration of a local anaesthetic medicinal product prior to injection of Xiapex into a Dupuytren's cord is not recommended, as it may interfere with proper placement of the injection.
Croatian: Ne preporučuje se primjena lokalnog anestetika prije injiciranja Xiapexa u Dupuytrenov tračak, jer bi mogao omesti pravilno uvođenje injekcije.
English: How Xiapex is used
Croatian: Kako se Xiapex primjenjuje
English: Retreatment of recurrent contractures
Croatian: Ponovno liječenje recidiva kontraktura
English: The solvent is a clear colourless solution.
Croatian: Otapalo je bistra, bezbojna otopina.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent vial for use with Xiapex label
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Naljepnica bočice s otapalom za primjenu sa Xiapexom
English: • breathing trouble
Croatian: • otežano disanje
English: Table 8 provides the baseline disease characteristics for the study population and Tables 9 -10 provide the results of the co-primary efficacy endpoints measured in the 2 double-blind placebo-controlled studies AUX-CC-803 and AUX-CC-804.
Croatian: U tablici 8 prikazana su početna obilježja bolesti ispitivane populacije, a u tablicama 9 i 10 rezultati dvaju primarnih ishoda djelotvornosti mjerenih u 2 dvostruko slijepa, placebom kontrolirana ispitivanja AUX-CC-803 i AUX-CC-804.
English: b) After removal of the flip-off cap from each vial, using aseptic technique swab the rubber stopper and surrounding surface of the vial containing Xiapex and the vial containing the diluent for reconstitution with sterile alcohol (no other antiseptics should be used).
Croatian: b) Nakon uklanjanja plastičnih poklopaca s obje bočice, koristeći se aseptičnom tehnikom obrišite gumeni čep i okolnu površinu bočice koja sadrži Xiapex i bočice koja sadrži otapalo za rekonstituciju sterilnim alkoholom (ne smije se upotrijebiti neki drugi antiseptik).
English: Instructions on how to gently stretch your penis
Croatian: Upute za nježno ispravljanje penisa
English: The reconstituted solution of Xiapex must be clear.
Croatian: Rekonstituirana otopina Xiapexa mora biti bistra.
English: Penis injury a Includes: injection site haematoma and penile haematoma were reported with the verbatim term of penile bruising or injection site bruising in 87% of patients.
Croatian: Ozljede, trovanja i proceduralne komplikacije bol prilikom postupka fraktura penisa laceracija kože otvorena rana hematom skrotuma ozljeda zgloba ozljeda penisa a Uključuje: hematom na mjestu injekcije i hematom penisa zabilježeni su doslovnim izrazima modrica na penisu ili modrica na mjestu injekcije u 87% bolesnika.
English: PIP Jointsb
Croatian: PIP zglobovib
English: • purple bruising and swelling of your penis
Croatian: • ljubičaste modrice i oticanje Vašeg penisa
English: Xiapex significantly reduced patient-reported bother associated with Peyronie's disease compared with placebo (Table 10).
Croatian: U bolesnika koji su primali Xiapex tegobe povezane s Peyronijevom bolešću znatno su se smanjile u usporedbi s onima koji su primali placebo (tablica 10).
English: • painful glands near the elbows or under the arm
Croatian: • bolne žlijezde u blizini lakta ili u pazuhu
English: Demographic and baseline characteristics Phase 3 Double-Blind, Placebo controlled studies (CORD I, CORD II)
Croatian: Dvostruko slijepa, placebom kontrolirana ispitivanja faze III (CORD I, CORD II) VARIJABLA
English: The overall safety profile was similar in the two Phase 3 double-blind placebo-controlled studies (832 male patients, 551 patients received Xiapex) and in an open-label Phase 3 study (189 male patients) of patients who had previously received placebo in the controlled studies.
Croatian: (832 muška bolesnika, 551 bolesnik primio je Xiapex) i jednom ispitivanju faze 3 otvorenog tipa (189 muških bolesnika) u bolesnika koji su prethodno primili placebo u kontroliranim ispitivanjima.
English: Mean Percent Change from Baseline in Curvature Deformity at Week 36 (LOCF) (mITT* Population) - study AUX-CC-806
Croatian: Tablica 11. Srednja vrijednost postotka promjene od početne deformirajuće zakrivljenosti u 36. tjednu (LOCF) (mITT* populacija) - ispitivanje AUX-CC-806 Xiapex N=126
English: Injection site cellulitis Lymphangitis
Croatian: Infekcije i infestacije celulitis na mjestu injiciranja limfangitis
English: Mean percent change in penile curvature deformity from baseline to week 52 - Studies 1 and 2
Croatian: Tablica 9. Srednji postotak promjene deformirajuće zakrivljenosti penisa od početka ispitivanja do 52. tjedna - Ispitivanja 1 i 2
English: Elevate the injected hand as much as possible until the day after the finger extension procedure.
Croatian: Nakon injekcije, držite šaku u povišenom položaju što više možete do dana nakon postupka ekstenzije prsta.
English: See Figure 1 below for an illustration of the injection technique.
Croatian: Za ilustraciju tehnike davanja injekcije, pogledajte sliku 1 niže.
English: Xiapex treatment significantly improved penile curvature deformity in patients with Peyronie's disease compared with placebo (Table 9).
Croatian: Liječenje Xiapexom u usporedbi s placebom značajno je poboljšalo deformirajuću zakrivljenost penisa u bolesnika s Peyronijevom bolešću (tablica 9).
English: Due to the lack of quantifiable systemic exposure of Xiapex in patients with Dupuytren's contracture and minimal and short-lived systemic exposure of Xiapex in patients with Peyronie's disease, no dose adjustment is necessary.
Croatian: Zbog nedostatka mjerljive sistemske izloženosti Xiapexu u bolesnika s Dupuytrenovom kontrakturom te minimalne i kratkotrajne sistemske izloženosti Xiapexu u bolesnika s Peyronijevom bolešću, nije potrebna prilagodba doze.
English: Before finger manipulation procedure will be performed tell your doctor, if you have a condition affecting your bones, e.g. osteopenia or osteoporosis.
Croatian: Prije provođenja postupka ekstenzije prsta recite liječniku ako imate neku bolest kostiju, npr.
English: Feeling hot Influenza like illness
Croatian: • bolest nalik gripi
English: • formation of a blood clot inside the penile vein
Croatian: • nastanak krvnog ugruška u veni penisa
English: Based on the Patient Global Assessment of Treatment Satisfaction, more than 85% of subjects in the CORD I and CORD II studies reported either being quite satisfied or very satisfied with their treatment with Xiapex versus approximately 30% treated with placebo (p<0.001).
Croatian: CORD I i CORD II izjavilo je da su dosta zadovoljni ili jako zadovoljni liječenjem Xiapexom nasuprot približno 30% liječenih placebom (p<0,001).
English: After removal of the flip-off cap from each vial, using aseptic technique swab the rubber stopper and surrounding surface of the vial containing Xiapex and the vial containing the diluent for reconstitution with sterile alcohol (no other antiseptics should be used).
Croatian: Nakon uklanjanja plastičnih poklopaca s obje bočice, koristeći se aseptičnom tehnikom obrišite gumeni čep i okolnu površinu bočice koja sadrži Xiapex i bočice koja sadrži otapalo za rekonstituciju sterilnim alkoholom (ne smije se upotrijebiti neki drugi antiseptik).
English: Mean Change from Baseline in Peyronie's Disease Bother Score at Week 36 (LOCF) (mITT* Population) - study AUX-CC-806
Croatian: Peyronijevu bolest u 36. tjednu (LOCF) (mITT* populacija) - ispitivanje AUX-CC-806 Xiapex N=126
English: c) Administer suitable local anaesthetic, if desired.
Croatian: Po želji, primijenite odgovarajući lokalni anestetik.
English: In the double-blind portion of the two phase 3 placebo-controlled clinical trials in Peyronie's disease, a greater proportion of Xiapex-treated patients (4%) compared to placebo-treated patients (1%) had localized pruritus after up to 4 treatment cycles (involving up to 8 Xiapex injections).
Croatian: Peyronijevom bolesti, veći udio bolesnika liječenih Xiapexom (4%) u usporedbi s bolesnicima liječenima placebom (1%) imao je lokaliziran svrbež nakon najviše 4 ciklusa liječenja (uključujući najviše 8 injekcija Xiapexa).
English: ∗ reported from a post-marketing clinical study in a patient who had previous exposure to Xiapex for the treatment of Dupuytren's contracture.
Croatian: * Zabilježeno u kliničkom ispitivanju nakon stavljanja lijeka u promet u bolesnika koji je prethodno bio izložen Xiapexu zbog liječenja Dupuytrenove kontrakture.
English: The recurrence day was the visit where the recurrence was reported or the day of intervention if a joint was treated for a worsening Dupuytren's contracture.
Croatian: Dan recidiva je dan posjeta na kojem je zabilježen recidiv ili dan intervencije ako je zglob liječen zbog pogoršanja
English: At baseline, penile pain was either not present or was mild in most (98%) patients.
Croatian: Na početku ispitivanja, većina bolesnika (98%) nije imala bol u penisu ili je ona bila blaga.
English: Diarrhoea Vomiting Abdominal pain upper
Croatian: Poremećaji probavnog sustava mučnina proljev povraćanje bol u gornjem dijelu abdomena
English: • The solvent contains calcium chloride dihydrate, sodium chloride and water for injections.
Croatian: - Otapalo sadrži kalcijev klorid dihidrat, natrijev klorid i vodu za injekcije.
English: A long-term, non-treatment, Year 2 to Year 5 follow-up study (AUX-CC-860) was undertaken to evaluate recurrence of contracture and long-term safety in subjects who received up to 8 single injections of Xiapex 0.58 mg in a previous Phase 3 open-label or double-blind with open-label extension study.
Croatian: (AUX-CC-860) kako bi se procijenio recidiv kontrakture i dugoročna sigurnost u ispitanika koji su primili do 8 pojedinačnih injekcija Xiapexa od 0,58 mg u prethodnom otvorenom ili dvostruko slijepom ispitivanju faze 3 s otvorenim produžetkom.
English: • reactions at the injection site like pain, warmth, swelling, presence of a blister, redness of skin and/or skin rash
Croatian: • reakcije na mjestu injekcije poput bola, topline, otečenosti, mjehura, crvenila kože i/ili kožnog osipa
English: Marketing Authorisation Holder Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Švedska
English: Two palpable cords affecting two joints may be injected or one palpable cord affecting two joints in the same finger may be injected at two locations during a treatment visit.
Croatian: Tijekom jednog terapijskog posjeta može se primijeniti injekcija u dva opipljiva tračka koja zahvaćaju dva zgloba ili se injekcija može primijeniti na dva mjesta u jedan opipljivi tračak koji zahvaća dva zgloba istog prsta.
English: If this syndrome were to develop, it would occur progressively and is characterized by one or more of the following signs and symptoms: arthralgia, myalgia, joint stiffness, stiffness of the shoulders, hand oedema, palmar fibrosis and thickening or nodules forming in the tendons.
Croatian: Ako se razvije taj sindrom, nastajat će postupno, a značajke su mu jedan ili više od sljedećih simptoma i znakova: artralgija, mialgija,
English: Xiapex must be administered by a physician appropriately trained in the correct administration of the medicinal product and experienced in the diagnosis and treatment of male urological diseases.
Croatian: Xiapex mora primijenjivati liječnik s odgovarajućom obukom u ispravnoj primjeni lijeka te iskusan u dijagnosticiranju i liječenju muških uroloških bolesti.
English: Inject the diluent slowly into the sides of the vial containing the lyophilized powder of Xiapex.
Croatian: Polagano ubrizgajte otapalo niz stijenku bočice koja sadrži liofilizirani prašak Xiapex.
English: • vomiting, diarrhoea, upper abdominal pain
Croatian: • povraćanje, proljev, bol u gornjem dijelu trbuha
English: Abdominal distension Constipation
Croatian: Poremećaji probavnog sustava distenzija abdomena konstipacija
English: Prior to use, the vial containing Xiapex and the vial containing the solvent for solution for reconstitution must be removed from the refrigerator and allowed to stand at room temperature for at least 15 minutes and no longer than 60 minutes.
Croatian: Prije primjene, bočica koja sadrži Xiapex i bočica koja sadrži otapalo za rekonstituciju otopine moraju se izvaditi iz hladnjaka i ostaviti na sobnoj temperaturi najmanje 15 minuta, ali ne dulje od 60 minuta.
English: The reconstituted Xiapex solution should be clear.
Croatian: Rekonstituirana otopina Xiapexa treba biti bistra.
English: The solvent should slowly be injected into the sides of the vial containing the lyophilised powder of Xiapex.
Croatian: Otapalo treba polagano ubrizgati niz stijenku bočice koja sadrži liofilizirani prašak Xiapex.
English: Yes No Physician Rating of Severity at Baseline Mild Moderate Severe Missing1 Note: Includes all patients who received at least 1 injection of double-blind study medicinal product (Xiapex 0.58 mg or placebo).
Croatian: Napomena: Uključuje sve bolesnike koji su primili najmanje 1 injekciju lijeka u dvostruko slijepom ispitivanju (Xiapex 0,58 mg ili placebo).
English: Package leaflet: Information for the user Xiapex 0.9 mg powder and solvent for solution for injection collagenase clostridium histolyticum
Croatian: Uputa o lijeku: Informacije za korisnika Xiapex 0,9 mg prašak i otapalo za otopinu za injekciju kolagenaza clostridium histolyticum
English: Complex regional pain syndrome Monoplegia Syncope vasovagal Tremor
Croatian: Poremećaji živčanog sustava parestezija hipoestezija osjećaj žarenja omaglica glavobolja kompleksni regionalni bolni sindrom monoplegija vazovagalna sinkopa tremor hiperestezija
English: • increased white blood cells
Croatian: • snižen broj krvnih pločica
English: TREATED PRIMARY JOINTS
Croatian: PRIMARNO LIJEČENI
English: • abnormal sensation
Croatian: • nenormalan osjet
English: 4.2 Posology and method of administration
Croatian: 4.2 Doziranje i način primjene Dupuytrenova kontraktura
English: All p-values < 0.001 for all comparisons between Xiapex and placebo, except for PIP joints in Study CORD II which was not eligible for statistical testing due to a hierarchical testing procedure.
Croatian: PIP zglobova u ispitivanju CORD II koji nisu bili pogodni za statističko testiranje zbog hijerarhijskog postupka testiranja.
English: If the reconstituted Xiapex solution is refrigerated, allow this solution to return to room temperature for approximately 15 minutes before use.
Croatian: Ako se rekonstituirana otopina Xiapexa čuva u hladnjaku, izvadite je otprilike 15 minuta prije primjene kako bi dosegla sobnu temperaturu.
English: • The active substance is collagenase clostridium histolyticum.
Croatian: - Djelatna tvar je kolagenaza clostridium histolyticum.
English: Slowly swirl the solution to ensure that all of the lyophilized powder has gone into solution.
Croatian: Polako promiješajte otopinu kružnim pokretima kako biste bili sigurni da je sav liofilizirani prašak prešao u otopinu.
English: The incidence of Xiapex-associated pruritus increased after more Xiapex injections in patients with Dupuytren's contracture.
Croatian: Incidencija pojave svrbeža povezanog s primjenom Xiapexa u bolesnika s Dupuytrenovom kontrakturom povećala se nakon više injekcija Xiapexa.
English: If the solution contains particulates, is cloudy, or is discoloured, do not inject the reconstituted solution.
Croatian: Ako rekonstituirana otopina sadrži čestice, zamućena je ili je promijenila boju, nemojte je injicirati.
English: • fever, general pain, discomfort, tiredness, feeling hot, malaise, flu-like illness
Croatian: • vrućica, generalizirani bol, nelagoda, umor, osjećaj vrućine, slabost, bolest nalik gripi • nepodnošenje hladnoće u liječenim prstima
English: Confirm the joint to be treated (metacarpophalangeal [MP] or proximal interphalangeal [PIP]) as the volume of solvent required for reconstitution is determined by the type of joint (PIP joint requires a smaller volume for injection).
Croatian: Odredite koji će se zglob liječiti (metakarpofalangealni [MP] ili proksimalni interfalangealni [PIP]) jer vrsta zgloba određuje volumen otapala potrebnog za rekonstituciju (za PIP zglob potreban je manji volumen za injekciju).
English: Following Xiapex injection, severe allergic reaction could occur, and patients should be observed for 30 minutes before leaving the clinic in order to monitor for 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: 30 minuta prije napuštanja ambulante kako bi se uočili bilo kakvi znakovi ili simptomi ozbiljne alergijske reakcije, npr. prošireno crvenilo ili osip, oticanje, stezanje u grlu ili otežano disanje.
English: Cases of skin laceration requiring skin graft after finger extension procedures have been reported postmarketing.
Croatian: Nakon stavljanja lijeka u promet zabilježeni su slučajevi laceracije kože koji su zahtijevali presađivanje kože nakon postupaka ekstenzije prsta.
English: Curvature*
Croatian: Zakrivljenost*
English: PDQ bother**
Croatian: Tegobe prema PDQ-u**
English: This includes medicines to help control the normal clotting of your blood (known as anticoagulation medicines), anthraquinone derivatives, some antibiotics (tetracyclines and anthracyclines/anthraquinolones) used to treat infections.
Croatian: derivate antrakinona, neke antibiotike (tetracikline i antracikline/antrakinolone) za liječenje infekcija.
English: Clinical study experience with Xiapex is currently limited to up to 3 injections per cord and up to 8 injections in total.
Croatian: Iskustvo iz kliničkih ispitivanja Xiapexa trenutno je ograničeno na najviše 3 injekcije po tračku i do 8
English: Baseline, mean (SD) Day 31, mean (SD) Change, mean (SD) FFC = Fixed flexion contracture ROM = Range of motion
Croatian: FFC = fiksna fleksijska kontraktura ROM = raspon pokreta
English: • superficial vein inflammation
Croatian: • upala površinskih vena
English: Total fixed flexion contracture and range of motion following administration of two concurrent injections of Xiapex 0.58 mg in the same hand, mITT population, study AUXCC-867 (first treatment cycle)
Croatian: Tablica 6. Cjelokupna fiksna fleksijska kontraktura i raspon pokreta nakon istovremene primjene dvije injekcije Xiapexa u dozi od 0,58 mg u istu šaku, populacija mITT, ispitivanje AUX
English: Contact your doctor right away if you are concerned by increasing pain or symptoms in the fingers after the treatment.
Croatian: Ako ste nakon terapijskog postupka zabrinuti zbog jačanja bolova ili nekih drugih simptoma povezanih s prstima, odmah se obratite liječniku.
English: The vial containing Xiapex and the vial containing the solvent for solution for injection for reconstitution must be refrigerated.
Croatian: Bočica koja sadrži Xiapex i bočica koja sadrži otapalo za rekonstituciju otopine za injekciju moraju biti u hladnjaku.
English: Reconfirm the cord to be injected.
Croatian: Ponovno utvrdite u koji tračak ćete dati injekciju.
English: • rupture of a tendon, ligament injury
Croatian: • puknuće tetive, ozljeda ligamenta
English: Tendon rupture or other serious injury to the injected finger/hand in the treatment of Dupuytren's contracture
Croatian: Ruptura tetive ili druge ozbiljne ozljede injiciranog prsta/šake u liječenju Dupuytrenove kontrakture Xiapex se smije injicirati samo u Dupuytrenov tračak.
English: In the double-blind portion of the three phase 3 placebo-controlled clinical studies in Dupuytren's contracture, 17% of Xiapex-treated patients had mild reactions (i.e. pruritus) after up to 3 injections.
Croatian: Dupuytrenovom kontrakturom, 17% bolesnika liječenih Xiapexom imalo je blage reakcije (tj. svrbež) nakon najviše 3 injekcije.
English: When Xiapex was given intravenously every other day to male and female rats before cohabitation and through mating and implantation, no effects on the oestrus cycle, tubal transport, implantation and pre-implantation development and/or on libido or epididymal sperm maturation were noted with intravenous doses up to 0.13 mg/dose (approximately 11 times the human dose on a mg/m2 basis).
Croatian: implantaciju i predimplantacijski razvoj i/ili libido ili sazrijevanje sperme u pasjemeniku kod intravenskih doza do 0,13 mg/dozi (približno 11 puta veće od ljudske doze na temelju mg/m2).
English: b “skin laceration” includes “injection site laceration” and “laceration” c “oedema peripheral” includes “injection site oedema” and “oedema” d see also section 4.4
Croatian: b „Laceracija kože“ uključuje „laceraciju na mjestu injekcije“ i „laceraciju“.
English: Haematoma Hypotension
Croatian: Krvožilni poremećaji hematomi hipotenzija
English: Gently stretch your penis 3 times a day.
Croatian: Nježno ispravljajte svoj penis jedanput na dan.
English: Headache Dizziness Dysgeusia Paraesthesia Burning sensation Hyperaesthesia Hypoaesthesia
Croatian: Poremećaji živčanog sustava glavobolja omaglica disgeuzija parestezija osjećaj žarenja hiperestezija hipoestezija
English: • scar tissue in penis
Croatian: • ožiljak na penisu
English: • burning sensation, partial loss of sensitivity, feeling of “pins and needles” or numbness
Croatian: • žarenje, djelomičan gubitak osjetljivosti, trnci i žmarci ili utrnulost
English: Penile fracture (corporal rupture) or other serious injury to the penis
Croatian: Prijelom penisa (ruptura korpusa) ili druge ozbiljne ozljede penisa
English: The solution should slowly be swirled to ensure that all of the lyophilised powder has gone into solution.
Croatian: Otopinu treba polako promiješati kružnim pokretima kako biste bili sigurni da je sav liofilizirani prašak prešao u otopinu.
English: • blood pressure increased
Croatian: • povišen krvni tlak • zadržavanje vode
English: An improvement from baseline was also seen in range of motion at Day 31 for all the treated joint pair subgroups, see Table 6.
Croatian: 31. dana bilo je opaženo i poboljšanje u rasponu pokreta u odnosu na početno stanje; vidjeti tablicu 6.
English: • disease of the lymph vessels
Croatian: • bolest limfnih žila
English: The efficacy of Xiapex 0.58 mg was evaluated in two pivotal randomized, double-blind, placebo-controlled studies, CORD I (AUX-CC-857) and CORD II (AUX-CC-859), in adult patients with Dupuytren's contracture.
Croatian: placebom kontrolirana ispitivanja, CORD I (AUX-CC-857) i CORD II (AUX-CC-859), u odraslih bolesnika s Dupuytrenovom kontrakturom.
English: • To return to see their physician approximately 24-72 hours after injection for an examination of the injected hand and a finger extension procedure to disrupt the cord.
Croatian: • približno 24-72 sata nakon injekcije posjete liječnika radi pregleda injicirane šake i postupka ekstenzije prsta da bi se razbio tračak.
English: a) Before use, remove the vial containing the lyophilized powder of Xiapex and the vial containing the diluent for reconstitution from the refrigerator and allow the two vials to stand at room temperature for at least 15 minutes and no longer than 60 minutes.
Croatian: a) Prije primjene, bočicu koja sadrži liofilizirani prašak Xiapex i bočicu koja sadrži otapalo za rekonstituciju otopine izvadite iz hladnjaka i ostavite obje bočice na sobnoj temperaturi najmanje 15 minuta i ne dulje od 60 minuta.
English: Study 1 or 2 b Each PDQ assessment required subjects to have had vaginal intercourse in the
Croatian: Ispitanici su bili iz ITT populacije i primili su najmanje jednu dozu ispitivanog lijeka u Ispitivanju 1 ili 2 b Svaka procjena upitnikom PDQ zahtijevala je da ispitanici imaju vaginalni snošaj unutar 3 mjeseca prije ispunjavanja upitnika c Veći broj bodova označava teže simptome
English: • popping sound/sensation indicating penile fracture
Croatian: • pucketajući zvuk/osjećaj koji upućuje na prijelom penisa • povišen šećer u krvi