FrancophonIA/ELRC3.0 huggingface dataset:
English: The figures 1 and 2 below are for illustrative purposes only and may not be representative of the precise location of anatomical structures in an individual patient.
Croatian: Slike 1 i 2 niže služe samo za ilustraciju i ne pokazuju točno mjesto anatomskih struktura u pojedinog bolesnika.
English: • Xiapex is given as part of a treatment cycle.
Croatian: • Xiapex se daje kao dio ciklusa liječenja.
English: Before you are given this medicine, make sure your doctor knows:
Croatian: Prije nego što dobijete ovaj lijek, budite sigurni da je liječnik upoznat sa sljedećim:
English: For many people, a contracture causes significant difficulties with performing everyday tasks like driving, shaking hands, playing sports, opening jars, typing or holding objects.
Croatian: Mnogim ljudima ta kontraktura uzrokuje značajne poteškoće u izvođenju svakodnevnih zadataka poput upravljanja vozilom, rukovanja, bavljenja sportom, otvaranja staklenki, tipkanja i držanja predmeta.
English: • Your doctor will also tell you when to come back if more treatment cycles are needed.
Croatian: • Vaš će Vam liječnik također reći kada da ponovo dođete ako je potrebno više ciklusa liječenja.
English: Talk to your doctor or pharmacist before you are given Xiapex.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primite Xiapex.
English: Contents of the pack and other information What Xiapex contains
Croatian: Sadržaj pakiranja i druge informacije Što Xiapex sadrži
English: Preparation - Reconstitution procedure
Croatian: Priprema - postupak rekonstitucije
English: You must limit motion of the treated finger for a day and it is not uncommon for the finger to straighten on its own for some patients.
Croatian: Morat ćete ograničiti pokrete liječenog prsta na jedan dan i nije neuobičajeno da se u nekih bolesnika prst sam ispravi.
English: There were no changes in the international index of erectile function (IIEF) scores.
Croatian: Nije bilo promjena u rezultatu prema međunarodnom indeksu erektilne funkcije (engl. international index of erectile function, IIEF).
English: • if you have had an allergic reaction to a previous Xiapex injection.
Croatian: • ako ste imali alergijsku reakciju na prethodnu injekciju Xiapexa.
English: Severe allergic reaction has been reported uncommonly (1 case).
Croatian: Teška alergijska reakcija zabilježena je manje često (1 slučaj).
English: It is recommended to avoid strenuous activities of your finger until instructed further by your doctor.
Croatian: Preporučuje se izbjegavati aktivnosti koje opterećuju prst dok ne dobijete daljnje upute od liječnika.
English: Total FFC (°)
Croatian: Ukupni FFC (°)
English: These data support the long-term safety profile of Xiapex confirming that no new safety risks were identified during the 5 year follow-up period.
Croatian: Ovi podaci podupiru dugoročni sigurnosni profil Xiapexa potvrđujući da nisu uočeni novi sigurnosni rizici tijekom petogodišnjeg razdoblja praćenja.
English: The mean age was 63 years (range 33 to 89 years) and 80% of patients were male.
Croatian: Srednja dob bila je 63 godine (raspon od 33 do 89 godina) i 80% bolesnika bili su muškarci.
English: The duration of assessment started at the day of success (visit after the last injection where the 0° to 5° measurement was first recorded).
Croatian: Trajanje procjene počinjalo je na dan postignutog uspjeha (posjet nakon posljednje injekcije pri kojem je prvi put zabilježeno 0 - 5°).
English: Patients with penile curvature >90° were not included in the clinical studies.
Croatian: Bolesnici sa zakrivljenošću penisa >90° nisu bili uključeni u klinička ispitivanja.
English: Improvement was observed regardless of joint type or finger involvement (range: 60.5% to 83.9%).
Croatian: Poboljšanje je bilo opaženo bez obzira na vrstu zgloba ili zahvaćeni prst (raspon: 60,5% do 83,9%).
English: After confirming that the needle is correctly placed in the cord, inject approximately one-third of the dose.
Croatian: Nakon što potvrdite da je igla ispravno postavljena u tračak, ubrizgajte približno jednu trećinu doze.
English: The interval between treatment cycles is approximately six weeks.
Croatian: Vremenski interval između ciklusa liječenja iznosi otprilike 6 tjedana.
English: All plasma levels were below the limits of quantification within 30 minutes following dosing.
Croatian: Sve razine u plazmi bile su ispod granice kvantifikacije unutar 30 minuta od primjene.
English: c The nominal rate of recurrence was the total number of recurrences occurring prior to the last day of the interval divided by the total number of joints (×100).
Croatian: c Nominalna stopa recidiva bila je ukupan broj recidiva koji su nastupili prije posljednjeg dana razdoblja podijeljen s ukupnim brojem zglobova (×100).
English: Date of first authorisation: 28 February 2011 Date of latest renewal: 18 January 2016
Croatian: Datum posljednje obnove odobrenja: 18. siječnja 2016.
English: The median duration of disease was 4.9 years (range 2.0 to 27.9 years).
Croatian: Medijan trajanja bolesti iznosio je 4,9 godina (raspon: od 2,0 do 27,9 godina).
English: For plaques that are only a few millimetres in width, the distance of withdrawal of the syringe may be very minimal.
Croatian: Za plakove koji su široki samo nekoliko milimetara, pomak štrcaljke može biti minimalan.
English: Erectile dysfunction was reported in 52.9% of patients, and 27.5% reported previous trauma to penis.
Croatian: Erektilna disfunkcija bila je prijavljena u 52,9% bolesnika, a 27,5% prijavilo je prethodnu traumu penisa.
English: Your doctor will tell you when to remove the dressing.
Croatian: Vaš će Vam liječnik reći kada skinuti povoj.
English: Penile modelling procedure
Croatian: Postupak modeliranja penisa
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, or embryonal/foetal development, (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak na plodnost, trudnoću i embrionalni/fetalni razvoj (vidjeti dio 5.3).
English: b p-value < 0.05.
Croatian: b p-vrijednost <0,05.
English: • The treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy (see sections 4.2 and 4.4).
Croatian: • liječenje odraslih muškaraca s Peyronijevom bolešću s opipljivim plakom i deformirajućom zakrivljenošću od najmanje 30 stupnjeva na početku terapije (vidjeti dijelove 4.2 i 4.4).
English: The maximal individual plasma concentrations of AUX-I and AUX-II were <29 ng/mL and <71 ng/mL, respectively.
Croatian: Najveće individualne koncentracije AUX-I u plazmi bile su <29 ng/ml, a AUX-II <71 ng/ml.
English: Age category (years), n (%)
Croatian: Dobna skupina (godine), n (%)
English: If the curvature deformity is less than 15 degrees after the first, second or third treatment cycle, or if the physician determines that further treatment is not clinically indicated, then the subsequent treatment cycles should not be administered.
Croatian: Ako je deformirajuća zakrivljenost manja od 15 stupnjeva nakon prvog, drugog ili trećeg ciklusa liječenja ili ako liječnik zaključi da daljnje liječenje nije klinički indicirano, daljnji ciklusi liječenja ne smiju se primijeniti.
English: Peyronie's disease occurs exclusively in adult male patients and hence there is no relevant information for use in females.
Croatian: Peyronijeva bolest javlja se isključivo u odraslih muških bolesnika i zato nema relevantnih informacija za primjenu u žena.
English: You must not be given Xiapex if you know that you have had a serious allergic reaction to collagenase or any of the other ingredients.
Croatian: Ne smijete dobiti Xiapex ako znate da ste imali ozbiljnu alergijsku reakciju na kolagenazu ili bilo koji drugi sastojak ovog lijeka.
English: • Let go of the tip of your penis and let your penis return to its normal length.
Croatian: • Pustite vrh penisa i dopustite da se vrati na uobičajenu duljinu.
English: Cases of finger necrosis have been reported, which in some cases led to amputation of finger parts.
Croatian: Prijavljeni su slučajevi nekroze prsta, koji su u nekim slučajevima doveli do amputacije dijelova prsta.
English: The median age was 58 years (range 23 to 84 years).
Croatian: Medijan dobi iznosio je 58 godina (raspon 23 do 84 godine).
English: • Your doctor will show you how to gently stretch and straighten your penis the right way.
Croatian: • Vaš će Vam liječnik pokazati kako nježno istegnuti i ispraviti penis na pravilan način.
English: If you notice such symptoms you should inform your doctor.
Croatian: Ako primijetite takve simptome, obavijestite Vašeg liječnika.
English: Nominal Change in Recurrence Rate vs Previous Year (%)
Croatian: Nominalna promjena stope recidiva naspram prethodne godine (%)
English: Other medicines and Xiapex
Croatian: Drugi lijekovi i Xiapex
English: • With one hand hold your penis.
Croatian: • Jednom rukom držite svoj penis.
English: A total of 189 patients were enrolled and treated with Xiapex.
Croatian: Ukupno je 189 bolesnika bilo uključeno i liječeno Xiapexom.
English: Xiapex has not been studied in children and adolescents aged 0-18 years and hence no pharmacokinetic data are available.
Croatian: Xiapex nije ispitan u djece i adolescenata u dobi od 0 do 18 godina pa stoga nema dostupnih farmakokinetičkih podataka.
English: (degrees)
Croatian: (stupnjevi)
English: • sexual dysfunction
Croatian: • seksualna disfunkcija
English: In Study AUX-CC-867, most (85%) subjects received local anaesthesia prior to the finger extension procedure.
Croatian: U ispitivanju AUX-CC-867, većina ispitanika (85%) je primila lokalnu anesteziju prije postupka ekstenzije prsta.
English: Patients should be instructed:
Croatian: Bolesnicima je potrebno savjetovati da:
English: The powder is a white lyophilised powder.
Croatian: Prašak je bijeli liofilizirani prašak.
English: • pain at the injection site and above the penis
Croatian: • bol na mjestu injekcije i iznad penisa
English: There were no adverse reactions on early embryonic development (indicating no evidence of teratogenicity) in rats.
Croatian: Nije bilo nuspojava tijekom ranog embrionalnog razvoja (što znači da nema dokaza teratogenosti) u štakora.
English: Patients should be instructed to comply with the treatment instructions (see section 4.2) and to promptly contact the physician if there is trouble bending the finger after the swelling goes down (symptoms of tendon rupture).
Croatian: Bolesnicima treba savjetovati da se pridržavaju uputa za liječenje (vidjeti dio 4.2) i da se odmah jave liječniku ako imaju poteškoća sa savijanjem prsta nakon što oteklina splasne (simptomi rupture tetive).
English: The signs and symptoms of Peyronie's disease are caused by a collagen plaque.
Croatian: Znakovi i simptomi Peyronijeve bolesti uzrokovani su kolagenskim plakom.
English: In the unlikely event that your doctor administers a higher dose than recommended, you may experience an increase in the severity of possible side effects listed in section 4 “Possible Side Effects”.
Croatian: U malo vjerojatnom slučaju da liječnik primijeni višu dozu od preporučene, možete osjetiti jače moguće nuspojave navedene u dijelu 4 “Moguće nuspojave”.
English: This is called a corporal rupture or penile fracture.
Croatian: To se naziva ruptura korpusa ili prijelom penisa.
English: Patients must be instructed to avoid potentially hazardous tasks such as driving or using machines until it is safe to do so or as advised by the physician.
Croatian: Bolesnicima se mora savjetovati da izbjegavaju potencijalno opasne zadatke kao što su upravljanje vozilima i rad sa strojevima sve dok ne bude sigurno obavljati takve radnje ili dok to ne savjetuje liječnik.
English: Each injection was separated by approximately 4 weeks.
Croatian: Injekcije su se davale u razmaku od približno 4 tjedna.
English: The goal is to gradually create bending opposite to the patient's penile curvature, with stretching to the point of moderate resistance.
Croatian: Cilj je postupno savijanje u smjeru suprotnom od zakrivljenosti penisa bolesnika, s istezanjem do točke umjerenog otpora.
English: The flip-off plastic caps should be removed from both vials.
Croatian: Treba ukloniti plastične poklopce s obje bočice.
English: • if you are currently taking any anticoagulation medicines, you must not receive Xiapex within 7 days of last dose of your anticoagulation medicine.
Croatian: • ako trenutno uzimate antikoagulanse, ne smijete primiti Xiapex unutar 7 dana od zadnje doze antikoagulansa.
English: What Xiapex looks like and contents of the pack
Croatian: Kako Xiapex izgleda i sadržaj pakiranja
English: Both collagenases effectively cleave interstitial collagen but at different sites on the molecule; additionally, they prefer different conformations (triple helical versus denatured or cleaved).
Croatian: Obje kolagenaze učinkovito cijepaju intersticijski kolagen, ali na različitim mjestima na molekuli; osim toga, odabiru različite konformacije (trostruki heliks nasuprot denaturiranom ili rascijepljenom).
English: If you are treated for Peyronie's disease
Croatian: Ako se liječite zbog Peyronijeve bolesti
English: For patients who achieved a contracture of the selected joint to 5° or less, the mean number of injections required to achieve this was 1.5 in the 2 studies.
Croatian: U bolesnika u kojih se postiglo da kontraktura odabranog zgloba bude 5° ili manja, prosječni broj injekcija potrebnih da se to postigne u ova dva ispitivanja iznosio je 1,5.
English: At study entry, patients must have had penile curvature deformity of at least 30 degrees in the stable phase of Peyronie's disease.
Croatian: Na ulasku u ispitivanje, bolesnici su morali imati deformirajuću zakrivljenost penisa od najmanje 30 stupnjeva u stabilnoj fazi Peyronijeve bolesti.
English: • Recognition and treatment of severe immune-mediated reaction, including anaphylaxis.
Croatian: • Prepoznavanje i liječenje teške, imunološki posredovane reakcije, uključujući anafilaksiju.
English: All patients had participated in and completed the studies AUX-CC-803 or AUX-CC-804, in which they had received placebo.
Croatian: Svi su bolesnici bili sudjelovali i završili ispitivanja AUX-CC-803 ili AUX-CC-804, u kojima su primali placebo.
English: A treatment course consists of a maximum of 4 treatment cycles.
Croatian: Kura liječenja sastoji se od najviše 4 ciklusa liječenja.
English: IIEF erectile function**
Croatian: Erektilna funkcija prema IIEFu**
English: The finger extension procedures were performed approximately 24 to 72 hours after injection.
Croatian: Postupci ekstenzije prsta bili su provedeni približno 24 do 72 sata nakon injekcije.
English: Your doctor will take care of storing, handling and disposing of Xiapex.
Croatian: Vaš liječnik će paziti na čuvanje, rukovanje i uklanjanje Xiapexa.
English: The two polypeptides are purified by chromatographic steps customary for the separation and isolation of biotherapeutic proteins to yield a consistent, well characterized and controlled mixture of two collagenase enzymes.
Croatian: Ta dva polipeptida pročišćeni su u kromatografskim koracima uobičajenima za odvajanje i izolaciju bioterapijskih proteina za dobivanje konzistentne, dobro definirane i kontrolirane mješavine dva enzima kolagenaze.
English: Results showed no cross-reactivity with any of the five MMPs tested.
Croatian: Rezultati nisu pokazali križnu reaktivnost ni s jednom od pet ispitivanih matriksnih metaloproteinaza.
English: Severe injury like e.g. finger necrosis or fracture could result in loss of finger or finger parts.
Croatian: Teška ozljeda kao što je npr. nekroza ili prijelom prsta može dovesti do gubitka prsta ili dijelova prsta.
English: Standard two-year rodent bioassays have not been performed with Xiapex.
Croatian: Standardna dvogodišnja biološka ispitivanja na glodavcima nisu provedena za Xiapex.
English: • Reminder of the need to report adverse events, including medication errors.
Croatian: • Podsjetnik da je potrebno prijaviti nuspojave, uključujući i pogreške u primjeni lijeka.
English: What Xiapex is and what it is used for
Croatian: Što je Xiapex i za što se koristi
English: Time of finger extension after injection had no impact on the rate of clinical success for either MP or PIP joints.
Croatian: Vrijeme do ekstenzije prsta nakon injekcije nije utjecalo na stopu kliničkog uspjeha ni kod MP niti kod PIP zglobova.
English: Intralesional use.
Croatian: Intralezijska primjena.
English: If you experience dizziness, numbness or altered sensation, and headache immediately after an injection of Xiapex you must avoid potentially hazardous tasks such as driving or using machines until these effects have passed or until advised by your doctor.
Croatian: Ako osjećate omaglicu, utrnulost ili promjene osjeta te glavobolju neposredno nakon injekcije Xiapexa, morate izbjegavati potencijalno opasne zadatke kao što su upravljanje vozilima i strojevima sve dok ti učinci ne prođu ili dok Vam to ne savjetuje liječnik.
English: Incorrect injection into tendons, nerves or blood vessels may result in bleeding or damage and possible permanent injury to these structures.
Croatian: Pogrešno ubrizgavanje u tetive, živce ili krvne žile može dovesti do krvarenja ili oštećenja i moguće trajne ozljede tih struktura.
English: j) The second injection of each treatment cycle should be made approximately 2 to 3 mm apart from the first injection.
Croatian: j) Druga injekcija svakog ciklusa liječenja treba se dati otprilike 2-3 mm dalje od prve injekcije.
English: • Injection technique and dosing interval.
Croatian: • Tehniku primjene injekcije i interval doziranja.
English: The duration of assessment ended at the last available measurement or at the day of medical intervention for joints that did not recur and the recurrence day for recurrent joints.
Croatian: Trajanje procjene završavalo je pri zadnjem dostupnom mjerenju ili na dan medicinske intervencije za zglobove koji nisu imali recidiv i na dan recidiva za zglobove na kojima je došlo do recidiva kontrakture.
English: Volumes needed for administration
Croatian: Volumeni potrebni za primjenu
English: If a satisfactory response has not been achieved, the injection and finger extension procedures may be repeated after approximately 4 weeks.
Croatian: Ako se nije postigao zadovoljavajući odgovor, injekcija i postupak ekstenzije prsta mogu se ponoviti nakon otprilike 4 tjedna.
English: Each treatment cycle consists of two Xiapex injections and one penile modelling procedure.
Croatian: Svaki ciklus liječenja sastoji se od dvije injekcije Xiapexa i jednog postupka modeliranja penisa.
English: Reconstitute with appropriate volume before use.
Croatian: Prije primjene rekonstituirati s odgovarajućim volumenom otapala.
English: Peyronie's plaque
Croatian: Peyronijev plak
English: Men with Peyronie's disease may have an erection that is curved or bent.
Croatian: Muškarci s Peyronijevom bolešću mogu imati zakrivljenu ili savijenu erekciju.
English: Figure 1: Illustration of the injection technique.
Croatian: Slika 1: Ilustracija tehnike injiciranja.
English: There will be a small amount of reconstituted solution left in the vial.
Croatian: Mala količina rekonstituirane otopine ostat će u bočici.
English: As with any non-human protein medicinal product, patients may develop antibodies to the therapeutic protein.
Croatian: Kao na svaki drugi proteinski lijek koji nije ljudskog podrijetla, bolesnici mogu razviti protutijela i na ovaj protein koji se primjenjuje u terapijske svrhe.
English: The following information is intended for Peyronie's disease patients only:
Croatian: Sljedeće informacije namijenjene su samo oboljelima od Peyronijeve bolesti:
English: Collagenases are proteinases that hydrolyze collagen under physiological conditions.
Croatian: Kolagenaze su proteinaze koje hidroliziraju kolagen u fiziološkim uvjetima.
English: In other Xiapex-treated patients (9 of 1044; 0.9%), a combination of penile ecchymoses or haematoma, sudden penile detumescence, and/or a penile “popping” sound or sensation was reported, and in these cases, a diagnosis of corporal rupture cannot be excluded.
Croatian: U drugih bolesnika liječenih Xiapexom (9 od 1044; 0,9%) zabilježena je kombinacija ekhimoza ili hematoma penisa, iznenadna detumescencija penisa i/ili pucketajući zvuk ili osjećaj u penisu i u tim slučajevima ne može biti isključena dijagnoza rupture korpusa.
English: The goal is always to deposit the full dose entirely within the plaque.
Croatian: Cilj je uvijek cijelu dozu injicirati samo u plak.
English: • fractured finger • loss of finger or finger parts
Croatian: • prijelom prsta • gubitak prsta ili dijelova prsta.
English: • a small collection of blood under the skin at the injection site
Croatian: • mala nakupina krvi pod kožom na mjestu injekcije
English: Neutralizing antibodies were assayed for a subset of 70 samples selected to be representative of high and low titer binding antibody responses at week 12 of treatment.
Croatian: Neutralizirajuća protutijela testirana su na podskupini od 70 uzoraka odabranih kao reprezentativnih za visok i nizak titar odgovora vezujućih protutijela u dvanaestom tjednu liječenja.
English: For further information see “Instructions on how to gently stretch your penis” and “Instructions on how to gently straighten your penis” at the end of the Patient leaflet.
Croatian: Za daljnje informacije pogledajte "Upute za nježno istezanje penisa" i "Upute za nježno ispravljanje penisa" na kraju Upute o lijeku.
English: Injection procedure a) The reconstituted Xiapex solution should be clear.
Croatian: Postupak injiciranja a) Rekonstituirana otopina Xiapexa treba biti bistra.
English: Administration of Xiapex at greater than recommended doses is expected to be associated with increased local reactions at the site of injection.
Croatian: Očekuje se da će primjena Xiapexa u dozi većoj od preporučene biti povezana s povećanim lokalnim reakcijama na mjestu primjene injekcije.
English: Cumulative Nominal Recurrence Rate (%)c
Croatian: Kumulativna nominalna stopa recidiva (%)c
English: The total volume of the injection depends on the joint being treated.
Croatian: Ukupni volumen injekcije ovisi o zglobu koji se liječi.
English: The injection procedure is detailed in the package leaflet and the physician training material and must be followed.
Croatian: Postupak injiciranja detaljno je opisan u uputi o lijeku i materijalu za obuku liječnika i mora se slijediti.
English: • avoidance of sex
Croatian: • izbjegavanje spolnih odnosa
English: For each subject in whom a Week 12 sample was selected, the corresponding Week 6, 18, 24, and 52 samples were assayed if they were also binding antibody positive.
Croatian: Za svakog ispitanika čiji je uzorak iz dvanaestog tjedna odabran, odgovarajući uzorci u 6. 18., 24. te 52. tjednu također su testirani ako su bili pozitivni na vezujuća protutijela.
English: • You should only gently stretch your penis when you do not have an erection.
Croatian: • Penis trebate nježno istezati samo kada nemate erekciju.
English: What Xiapex is and what it is used for What you need to know before you are given Xiapex How Xiapex is used
Croatian: Što je Xiapex i za što se koristi Što morate znati prije nego primite Xiapex
English: With your other hand, gently bend your penis in the opposite direction of the curve (see Figure 4).
Croatian: Svojom drugom rukom nježno savijte penis u smjeru suprotnom od zakrivljenosti (pogledajte sliku 4).
English: • After a 30 second rest period, repeat the penile modelling technique for a total of 3 modelling attempts at 30 seconds for each attempt.
Croatian: • Nakon 30 sekundi odmora ponovite tehniku modeliranja penisa do ukupno 3 pokušaja modeliranja, s 30 sekundi za svaki pokušaj.
English: Table 13: Long Term Efficacy variables - study AUX-CC-810 Baselinea
Croatian: Tablica 13: Varijable dugoročne djelotvornosti - ispitivanje AUX-CC-810
English: Your doctor will carefully select an area where the collagen cord is best accessible and will proceed with the injection into the cord.
Croatian: Liječnik će pažljivo odabrati područje gdje je dostupnost kolagenskog tračka najbolja i onda će dati injekciju u tračak.