FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Študije na živalih o vplivu na porod ali postnatalni razvoj niso bile izvedene, ker človeške farmakokinetične študije kažejo, da nivo zdravila Xiapex v sistemski cirkulaciji po injekciji v Dupuytrenov vozlič ni merljiv (glejte poglavje 5.1).
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.
Slovenian: Po injiciranju zdravila Xiapex se lahko pojavijo hude alergijske reakcije in bolnike je treba opazovati 30 minut, preden zapustijo kliniko, za spremljanje morebitnih znakov ali simptomov resnih alergijskih reakcij, npr. rdečina ali izpuščaj po celem telesu, oteklina, tiščanje v žrelu ali težave pri dihanju.
English: Call your doctor right away if you have any of these symptoms of an allergic reaction after an injection of Xiapex:
Slovenian: Takoj pokličite zdravnika, če imate po injiciranju zdravila Xiapex katerega koli od teh simptomov alergijske reakcije:
English: Figure 2: Three step injection of Xiapex into the cord.
Slovenian: Slika 2: trije koraki injiciranja zdravila Xiapex v vozlič
English: In the retreatment study AUX-CC-862, 150 anti-AUX-I antibody positive samples and 149 anti-AUX-II antibody positive samples were assessed for potential cross-reactivity with human MMPs-1, -2, -3, -8, and -13.
Slovenian: V študiji ponovnega zdravljenja AUX-CC-862 so ocenili 150 vzorcev, pozitivnih za protitelesa proti AUX-I, in 149 vzorcev, pozitivnih za protitelesa proti AUX-II, glede morebitne navzkrižne reaktivnosti s človeškimi MMP-1, -2, -3, -8 in -13.
English: • tremor/shaking, increased sensitivity to stimuli
Slovenian: • tremor/tresavica, povečana občutljivost na dražljaje;
English: On the basis of the scientific conclusions for collagenase clostridium histolyticum the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing collagenase clostridium histolyticum is unchanged subject to the proposed changes to the product information.
Slovenian: Na podlagi znanstvenih zaključkov za kolagenazo clostridium histolyticum odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) kolagenazo clostridium histolyticum,nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: After treatment with Xiapex, blood vessels in your penis may also break, causing blood to collect under the skin (which is called a haematoma).
Slovenian: Po zdravljenju z zdravilom Xiapex lahko počijo tudi krvne žile v penisu, kar povzroči kopičenje krvi pod kožo (to se imenuje hematom).
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.
Slovenian: Dan ponovitve je bil obisk, na katerem je bila ponovitev poročana, ali dan posega, če je bil sklep zdravljen zaradi poslabšanja Dupuytrenove kontrakture.
English: • You should only gently stretch your penis when you do not have an erection.
Slovenian: • Penis si lahko nežno raztezate le, ko nimate erekcije.
English: • agitation, disorientation, irritability, restlessness, difficulty sleeping
Slovenian: • vznemirjenost, motnje orientacije, razdražljivost, nemir, težave pri spanju;
English: Open wound
Slovenian: • odprta rana
English: Xiapex may have a major influence on the ability to drive and use machines due to the swelling and pain which may impair the use of the treated hand in Dupuytren's disease.
Slovenian: Zdravilo Xiapex utegne imeti pomemben vpliv na sposobnost vožnje in upravljanja strojev zaradi otekanja in bolečine, ki lahko ovirata uporabo zdravljene roke pri Dupuytrenovi bolezni.
English: Whilst there is no clinical evidence from the current safety data of a musculoskeletal syndrome developing following the administration of Xiapex, the potential for it to occur cannot be excluded.
Slovenian: Ker iz trenutnih varnostnih podatkov ni kliničnih dokazov o razvoju mišično-skeletnega sindroma po aplikaciji zdravila XIAPEX, možnosti za njegov razvoj ne moremo izključiti.
English: Figure 1: Illustration of the injection technique.
Slovenian: Slika 1: prikaz tehnike injiciranja
English: Following this disruption of the plaque, penile curvature deformity and patient bother caused by Peyronie's disease are reduced.
Slovenian: Po prekinitvi plaka se deformacija ukrivljenosti penisa in težave, ki jih bolniku povzroča Peyroniejeva bolezen, zmanjšajo.
English: If you are treated for Dupuytren's contracture
Slovenian: Če se zdravite zaradi Dupuytrenove kontrakture
English: • Wear the splint at bedtime for up to 4 months.
Slovenian: • naj nosijo opornico ponoči do 4 mesece dolgo,
English: Long Term Recurrence Rates for Joints Treated Successfully with XIAPEX
Slovenian: Dolgoročni delež ponovitve za sklepe, uspešno zdravljene z zdravilom XIAPEX
English: Identification of treatment area a) Prior to each treatment cycle, identify the treatment area as follows:
Slovenian: Določanje predela zdravljenja a) Pred začetkom cikla zdravljenja določite predel zdravljenja kot sledi:
English: If you are treated for Peyronie's disease
Slovenian: Če se zdravite zaradi Peyroniejeve bolezni
English: For Xiapex no clinical data on exposed pregnancies are available.
Slovenian: Za zdravilo Xiapex ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
English: • worsening of Peyronie's disease
Slovenian: • poslabšanje Peyroniejeve bolezni
English: • water retention
Slovenian: • zastajanje vode
English: Injection procedure
Slovenian: Postopek injiciranja
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).
Slovenian: • naj se takoj obrnejo na svojega zdravnika, če se pojavijo znaki okužbe (npr. vročina, mrzlica, povečanje rdečine ali edem) ali če imajo težave pri pregibanju prsta potem, ko oteklina splahni (simptomi rupture kite);
English: As with any non-human protein medicinal product, patients may develop antibodies to the therapeutic protein.
Slovenian: Imunogenost Kot pri drugih zdravilih, ki vsebujejo kakršnekoli beljakovine nehumanega izvora, lahko bolniki razvijejo protitelesa proti terapevtski beljakovini.
English: Following extension of your finger, your doctor will fit you with a splint to wear at bedtime for up to 4 months.
Slovenian: Po iztegovanju prstov vam bo zdravnik namestil opornico, da jo boste nosili ponoči do 4 mesece dolgo.
English: The solution must be clear, colourless with no lumps or flakes or particles.
Slovenian: Raztopina mora biti bistra, brezbarvna, brez grudic ali kosmičev ali delcev.
English: • Not to flex or extend the fingers of the injected hand to reduce extravasation of Xiapex out of the cord until the finger extension procedure is completed.
Slovenian: • naj ne krčijo ali iztegujejo prstov zdravljene roke, da ne bi zdravilo Xiapex uhajalo ven iz vozliča, dokler postopek iztegovanja prstov ne bo zaključen;
English: The mean (SD) FSFI score was 20.56 (10.08) at baseline and 26.72 (7.73) at week 36, a change from baseline of 7.54.
Slovenian: Povprečni (SD) seštevek FSFI je bil 20,56 (10,08) ob izhodšiču in 26,72 (7,73) v 36. tednu, tj. sprememba od izhodišča 7,54.
English: Contents of the pack and other information What Xiapex contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Xiapex
English: • For Peyronie's disease if the treatment of your plaque involves the tube (called the urethra) that your urine passes through.
Slovenian: • za Peyronijevo bolezen, če je v zdravljenje plaka vpletena cevka (imenovana sečnica), skozi katero prehaja urin.
English: b A recurrent joint was a joint evaluated by the investigator as having a worsening Dupuytren's contracture due to a palpable cord.
Slovenian: b Sklep, pri katerem je prišlo do ponovitve, je bil sklep, ki ga je raziskovalec ocenil s poslabšanjem Dupuytrenove kontrakture zaradi otipljivega vozliča.
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.
Slovenian: Poleg tega je treba na podlagi pregleda poročil o primerih iz obdobja trženja o zlomih penisa pri bolnikih s Peyroniejevo boleznijo odbor PRAC meni, da je treba informacije o zdravilu Xiapex posodobiti tako, da se vključi novo besedilo v poglavje 4.4 povzetka glavnih značilnosti zdravila in poglavje 2 navodila za uporabo, da se poveča najkrajše časovno obdobje med injiciranjem in ponovno spolno aktivnostjo na najmanj 4 tedne, in da je potrebna pri ponovni spolni aktivnosti previdnost.
English: The adverse reaction profile was similar after each injection, regardless of the number of injections administered.
Slovenian: Profil neželenih učinkov je bil podoben po vsakem injiciranju, ne glede na število danih injekcij.
English: The recommended dose of your prescribed medicine is 0.58 mg.
Slovenian: Priporočen odmerek predpisanega zdravila je 0,58 mg.
English: Severe allergic reactions can happen in patients who receive Xiapex, because it contains proteins foreign to the human body.
Slovenian: Bolniki, ki prejmejo zdravilo Xiapex, lahko doživijo hude alergijske reakcije, saj zdravilo vsebuje človeškemu telesu tuje beljakovine.
English: *A formulation of two collagenase enzymes co-expressed and harvested from anaerobic fermentation of a phenotypically selected strain of Clostridium histolyticum bacterium.
Slovenian: *Formulacija dveh encimov kolagenaz, ki se izražata skupaj in ju pridelajo z anaerobno fermentacijo fenotipsko izbranega seva bakterije Clostridium histolyticum.
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.
Slovenian: Če bi se ta sindrom razvil, bi se pojavil progresivno in zanj bi bili značilni eden ali več naslednjih znakov in simptomov: artralgija, mialgija, otrdelost sklepov, otrdelost v ramenih, edem rok, palmarna fibroza in zadebelitev ali nastajanje vozličev v kitah.
English: The double-blind study population comprised 409 patients of whom 272 received Xiapex 0.58 mg and 137 received placebo.
Slovenian: Populacijo dvojno slepe študije je sestavljalo 409 bolnikov, od katerih jih je 272 prejemalo zdravilo Xiapex 0,58 mg in 137 jih je prejemalo placebo.
English: At study entry, patients in the clinical studies had: (1) a finger flexion contracture with a palpable cord of at least one finger (other than the thumb) of 20° to 100° in a MP joint or 20° to 80° in PIP joint and (2) a positive “table top test” defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
Slovenian: Ob vključitvi v študijo so imeli bolniki v kliničnih študijah: (1) fleksijsko kontrakturo prsta z otipljivim vozličem na vsaj enem prstu (razen na palcu) 20° do 100° v MP sklepu ali 20° do 80° v PIP sklepu in (2) pozitiven “test mize”, ki je definiran kot nezmožnost hkratne postavitve prizadetega prsta (prstov) in dlani ravno na površino mize.
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.
Slovenian: Pri Dupuytrenovi bolezni zdravilo Xiapex razgradi kolagen, ki tvori vozlič, in s tem kontrakturo povsem ali delno sprosti ter omogoči prstu(om), da so bolj ravni.
English: In the controlled and uncontrolled clinical studies of Xiapex in Peyronie's disease corporal rupture and other serious penile injury were reported uncommonly (see section 4.4)
Slovenian: V nadzorovanih in nenadzorovanih kliničnih študijah z zdravilom Xiapex za Peyroniejevo bolezen so občasno poročali o rupturi korpusa in drugih resnih poškodbah penisa (glejte poglavje 4.4)
English: • breathing trouble
Slovenian: • težave z dihanjem
English: Signs or symptoms that may reflect serious injury to the treated finger/hand after injection or manipulation should be promptly evaluated because surgical intervention may be required.
Slovenian: Znake ali simptome, ki lahko kažejo na resno poškodbo zdravljenega prsta/roke po injiciranju ali obravnavi, je treba hitro oceniti, ker je morda potreben kirurški poseg.
English: Reconstitute with appropriate volume before use.
Slovenian: Samo za intralezijsko uporabo Pred uporabo rekonstituirajte z ustreznim volumnom.
English: The flip-off plastic caps should be removed from both vials.
Slovenian: Z obeh vial je treba odstraniti plastično dvižno zaporko.
English: In the pivotal clinical studies about 30% of the patients received penile block before injection.
Slovenian: V ključnih kliničnih študijah je blokado penisa pred injiciranjem prejelo približno 30 % bolnikov.
English: What Xiapex is and what it is used for
Slovenian: Kaj je zdravilo Xiapex in za kaj ga uporabljamo
English: Each vial of Xiapex and sterile solvent for reconstitution should only be used for a single injection.
Slovenian: Vsako vialo zdravila Xiapex in sterilni vehikel za rekonstitucijo se lahko uporabi le za eno injekcijo.
English: N (%) of Recurrent Joints in Each Intervalb
Slovenian: N (%) sklepov s ponovitvij o za vsak interval b
English: Different Fingers, Both PIPs (n=72)
Slovenian: Različna prsta, oba PIP (n = 72)
English: Anaphylactic reaction was reported in a patient previously treated with Xiapex (1 case).
Slovenian: O anafilaktični reakciji so poročali pri bolniku, predhodno zdravljenemu z zdravilom Xiapex (1 primer).
English: Your doctor will take care to avoid injecting into tendons, nerves or blood vessels.
Slovenian: Zdravnik bo pri tem pazil, da ne bo injiciral v kite, živce ali krvne žile.
English: If your finger is still not able to straighten during a follow-up visit with your doctor, you may need additional treatments with Xiapex which may be administered approximately 4 weeks after the first treatment.
Slovenian: Če svojega prsta med kontrolnim pregledom ne boste mogli iztegniti, boste morda potrebovali dodatna zdravljenja z zdravilom Xiapex, ki se ga lahko daje v razmaku 4 tedne po prvem zdravljenju.
English: It is not known whether collagenase clostridium histolyticum is excreted in human milk.
Slovenian: Ni znano, ali se kolagenaza clostridium histolyticum izloča v materino mleko.
English: Adverse reactions reported from the clinical programme are those that occurred in the Phase 3 double-blind placebo-controlled studies.
Slovenian: Neželeni učinki, o katerih so poročali iz kliničnega programa, so tisti, ki so se zgodili v dvojno slepih, s placebom nadzorovanih študijah 3. faze.
English: • Gently pull your penis away from your body to its full length and hold the stretch for
Slovenian: • Penis nežno povlecite stran od telesa do celotne dolžine in ga držite iztegnjenega 30 sekund.
English: Clinically meaningful improvement in hand function as determined by the URAM (Unite´ Rhumatologique des Affections de la Main) score was observed at Day 31 (-11.3) and Day 61 (-12.3).
Slovenian: Klinično pomembno izboljšanje funkcije roke, določeno po lestvici URAM (Unite´ Rhumatologique des Affections de la Main), so opazili na 31. dan
English: Store in a refrigerator at 2ºC-8ºC.
Slovenian: Shranjujte v hladilniku pri 2 ºC-8 ºC.
English: No patients had quantifiable plasma levels 15 minutes after modelling of plaque on Day 3 (i.e., 24 hours after Injection 2 on Day 2).
Slovenian: Noben od bolnikov 15 minut po modeliranju plaka 3. dan (tj. 24 ur po 2. injekciji 2. dan) ni imel merljivih ravni v plazmi.
English: Tendon rupture or other serious injury to the injected finger/hand in the treatment of Dupuytren's contracture
Slovenian: Ruptura kite ali druge resne poškodbe na zdravljenem prstu/zdravljeni roki pri zdravljenju Dupuytrenove kontrakture
English: The most frequently reported adverse drug reactions (≥25%) during the Xiapex controlled clinical studies were penile haematoma, penile swelling and penile pain.
Slovenian: Najpogosteje poročani neželeni učinki zdravila (≥ 25 %) med nadzorovanimi kliničnimi študijami z zdravilom Xiapex, so bili hematom penisa, oteklina penisa in bolečina v penisu.
English: Most adverse events were non-serious, mild or moderate in intensity, and related to the local administration of Xiapex or to the finger extension procedure to facilitate cord disruption.
Slovenian: Večina neželenih učinkov ni bilo resnih, in so bili po intenzivnosti blagi ali zmerni in povezani z lokalnim apliciranjem zdravila Xiapex ali s postopkom iztegovanja prstov za lažjo prekinitev vozliča.
English: Peyronie's disease
Slovenian: Peyroniejeva bolezen
English: The disease can cause a change in the shape of the erect penis due to the abnormal build-up of scar tissue, known as a plaque, within the stretchy fibres of the penis.
Slovenian: Bolezen lahko povzroči spremembo oblike penisa med erekcijo zaradi nenormalnega kopičenja brazgotinastega tkiva, znanega kot plak, v raztegljivih vlaknih penisa.
English: Until advised by your doctor, do not flex or extend the fingers of the injected hand.
Slovenian: Dokler vam tega ne dovoli zdravnik, prstov zdravljene roke ne smete upogibati ali iztegovati.
English: If insertion of the needle into a tendon is suspected or paresthesia is noted by the patient, withdraw the needle and reposition it into the cord.
Slovenian: Če sumite na vbod kite z iglo ali če bolnik navaja parestezije, izvlecite iglo in jo ponovno namestite v vozlič.
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.
Slovenian: Znake ali simptome, ki lahko odražajo resno poškodbo penisa, je treba takoj oceniti, da se ugotovi, če je prišlo do rupture korpusa ali hudega hematoma penisa, ki lahko zahtevata kirurški poseg.
English: • inflammation of the lymph nodes (lymphadenitis), inflammation of lymphatic channels (lymphangitis) leading to reddened skin with elevated borders, tender and warm, usually accompanied by a red streak, enlarged lymph nodes
Slovenian: • vnetje bezgavk (limfadenitis), vnetje limfnih kanalov (limfangitis), ki vodi do pordele kože z dvignjenimi robovi, občutljivosti in občutka toplote, kar običajno spremljajo rdeče lise, ter povečanih bezgavk.
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.
Slovenian: Reakcije na mestu aplikacije so bile zelo pogoste, pojavile so se pri veliki večini bolnikov, bile so večinoma blage do zmerne in so navadno izzvenele v enem do dveh tednih po injiciranju.
English: **Based on the 95% CI of the mean not including zero, the percent change from baseline was considered statistically significant.
Slovenian: ** Na podlagi 95-% IZ povprečja izključujoč nič je bila odstotna sprememba od izhodišča obravnavana kot statistično pomembna.
English: Store in a refrigerator (2ºC-8ºC).
Slovenian: Shranjujte v hladilniku (2 ºC-8 ºC).
English: Standard two-year rodent bioassays have not been performed with Xiapex.
Slovenian: Standardnih dvoletnih bioloških preskušanj na glodalcih z zdravilom Xiapex niso izvedli.
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.
Slovenian: Ob upoštevanju možnosti vzročne povezanosti med mehanizmom delovanja kolagenaze clostridium histolyticum in sledečih postopkov obravnave pri bolnikih z Dupuytrenovo kontraktururo odbor PRAC meni, da je treba informacije o zdravilu Xiapex posodobiti tako, da se vključijo opozorila v zvezi z nekrozo prstov, zaradi katere je bila v nekaterih primerih potrebna amputacija prsta, in opozorila glede zloma prsta, v poglavje 4.4 povzetka glavnih značilnosti zdravila.
English: Xiapex is used for the treatment of two different conditions: Dupuytren's contracture in adult patients with a palpable cord and Peyronie's disease in adult men.
Slovenian: Zdravilo Xiapex se uporablja za zdravljenje dveh različnih bolezni: Dupuytrenove kontrakture pri odraslih bolnikih s tipljivim vozličem in Peyroniejeve bolezni pri odraslih moških.
English: Do not store, pool, or use any vials containing unused reconstituted solution or solvent.
Slovenian: Ne shranjujte, zbirajte ali uporabljajte vial, ki vsebujejo neporabljeno rekonstituirano raztopino ali vehikel.
English: Your doctor must not use this medicine after the expiry date which is stated on the carton and vial label after EXP.
Slovenian: Vaš zdravnik tega zdravila ne sme uporabiti po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Penile modelling helps relieve curvature deformity and straighten the penile shaft.
Slovenian: Modeliranje penisa pomaga ublažiti deformacijo ukrivljenosti in izravnati penis.
English: Physicians should advise the patient to wait for at least 4 weeks after the second injection of a treatment cycle before resuming sexual activity taking care to ensure that any pain and swelling has ceased and to be cautious when resuming sexual activity.
Slovenian: Zdravniki morajo bolniku svetovati, naj pred ponovno spolno aktivnostjo počaka vsaj 4 tedne po drugi injekciji v ciklu zdravljenja, ko se prepriča, da sta vsakršna bolečina in oteklina izginili, ter naj bo previden pri nadaljevanju spolne aktivnosti.
English: Total (n=724)
Slovenian: Skupaj (n = 724)
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.
Slovenian: Zato je treba zdravilo Xiapex injicirati le v Peyroniejev plak in je potrebna previdnost, da se prepreči injiciranje v sečnico, živce, krvne žile, kavernozni telesi ali druge strukture penisa, ki vsebujejo kolagen.
English: The location of the target treatment area in the Peyronie's plaque is identified at the point of maximum concavity (or focal point) in the erect penis state and marked with a surgical marker.
Slovenian: Mesto ciljnega predela zdravljenja v Peyroniejevem plaku se določi na točki največje vbokline (ali fokalne točke) v stanju penisa med erekcijo in se ga označi s kirurškim markerjem.
English: Serious adverse reactions of tendon rupture (6 cases), tendonitis (1 case), other ligament injury (2 cases) and complex regional pain syndrome (1 case) related to the medicinal product were reported.
Slovenian: tendinitis (1 primer), druge poškodbe ligamentov (2 primera) in sindrom sestavljene regionalne bolečine (1 primer).
English: When administering two injections in the same hand during a treatment visit, begin with the affected finger in the most ulnar aspect of the hand and continue toward the radial aspect (eg, fifth finger to index finger).
Slovenian: Pri dajanju dveh injekcij v isto roko med obiskom za zdravljenje začnite s prizadetim prstom na najbolj ulnarni strani roke ter nadaljujte proti radialni strani (npr. mezinec proti kazalcu).
English: Age (years)
Slovenian: starost (leta)