natgillin/translations-raw huggingface dataset:
The most frequently reported adverse drug reactions (≥25%) during the Xiapex controlled clinical studies were penile haematoma, penile swelling and penile pain. 
Najpogosteje poročani neželeni učinki zdravila (≥ 25 %) med nadzorovanimi kliničnimi študijami z zdravilom Xiapex, so bili hematom penisa, oteklina penisa in bolečina v penisu.
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. 
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.
Peyronie's disease 
Peyroniejeva bolezen
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. 
Bolezen lahko povzroči spremembo oblike penisa med erekcijo zaradi nenormalnega kopičenja brazgotinastega tkiva, znanega kot plak, v raztegljivih vlaknih penisa.
Until advised by your doctor, do not flex or extend the fingers of the injected hand. 
Dokler vam tega ne dovoli zdravnik, prstov zdravljene roke ne smete upogibati ali iztegovati.
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. 
Če sumite na vbod kite z iglo ali če bolnik navaja parestezije, izvlecite iglo in jo ponovno namestite v vozlič.
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. 
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.
• 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 
• 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.
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. 
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.
**Based on the 95% CI of the mean not including zero, the percent change from baseline was considered statistically significant. 
** Na podlagi 95-% IZ povprečja izključujoč nič je bila odstotna sprememba od izhodišča obravnavana kot statistično pomembna.
Store in a refrigerator (2ºC-8ºC). 
Shranjujte v hladilniku (2 ºC-8 ºC).
Standard two-year rodent bioassays have not been performed with Xiapex. 
Standardnih dvoletnih bioloških preskušanj na glodalcih z zdravilom Xiapex niso izvedli.
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. 
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.
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. 
Zdravilo Xiapex se uporablja za zdravljenje dveh različnih bolezni: Dupuytrenove kontrakture pri odraslih bolnikih s tipljivim vozličem in Peyroniejeve bolezni pri odraslih moških.
Do not store, pool, or use any vials containing unused reconstituted solution or solvent. 
Ne shranjujte, zbirajte ali uporabljajte vial, ki vsebujejo neporabljeno rekonstituirano raztopino ali vehikel.
Your doctor must not use this medicine after the expiry date which is stated on the carton and vial label after EXP. 
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.
Penile modelling helps relieve curvature deformity and straighten the penile shaft. 
Modeliranje penisa pomaga ublažiti deformacijo ukrivljenosti in izravnati penis.
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. 
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.
Total (n=724) 
Skupaj (n = 724)
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. 
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.
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. 
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.
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. 
tendinitis (1 primer), druge poškodbe ligamentov (2 primera) in sindrom sestavljene regionalne bolečine (1 primer).
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). 
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).
Age (years) 
starost (leta)
The efficacy and safety of Xiapex in patients receiving anticoagulant medicinal products other than up to 150 mg acetylsalicylic acid per day prior to Xiapex administration is not known. 
Učinkovitost in varnost zdravila Xiapex pri bolnikih, ki dobivajo antikoagulantna zdravila, razen do 150 mg acetilsalicilne kisline na dan, pred dajanjem zdravila Xiapex, nista znani.
Other medicines and Xiapex 
Druga zdravila in zdravilo Xiapex
Local anaesthesia may be used, if needed, during the finger extension procedure. 
Po potrebi se lahko med postopkom iztegovanja prstov uporabi lokalna anestezija.
Your doctor will ask you to return approximately 24-72 hours after your injection to attempt to extend your finger to straighten it. 
Zdravnik vam bo naročil, da se vrnete približno 24 - 72 ur po injiciranju, da bo poskušal iztegniti vaš prst, da bi ga izravnal.
Only the supplied solvent must be used for reconstitution; it contains calcium which is required for the activity of Xiapex. 
Uporabljati je treba samo priložen vehikel za rekonstitucijo; vsebuje kalcij, ki je potreben za delovanje zdravila Xiapex.
Patients were excluded if they had a ventral curvature deformity, an isolated hourglass deformity or a calcified plaque that could have interfered with the injection technique. 
Izključeni so bili bolniki, ki so imeli ventralno deformacijo ukrivljenosti, izolirano deformacijo v obliki peščene ure ali kalcificiran plak, kar bi lahko vplivalo na tehniko injiciranja.
The CHMP recommends that the terms of the Marketing Authorisation should be varied. 
Odbor CHMP zato priporoča spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom.
The most frequently reported adverse reactions during the Xiapex clinical studies (272 of 409 patients received up to three single injections of Xiapex and 775 patients received two concurrent injections in the same hand) were local injection site reactions such as oedema peripheral (local to the injection site), contusion (including ecchymosis), injection site haemorrhage and injection site pain. 
Najpogosteje poročani neželeni učinki med kliničnimi študijami zdravila Xiapex (do tri enkratne injekcije zdravila Xiapex je prejelo 272 od 409 bolnikov in 775 bolnikov je prejelo dve sočasni injekciji v isto roko) so bili: reakcije na mestu aplikacije, kot na primer periferni edem (na mestu injiciranja), kontuzija (vključno z ekhimozo), krvavitev na mestu injiciranja in bolečina na mestu injiciranja.
If, at that subsequent visit the contracted cord persists, an additional injection and finger extension procedure may be performed. 
Če je kontrakturni vozlič na tem naknadnem obisku še prisoten, se lahko opravi dodatni postopek injiciranja in iztegovanja prstov.
In contrast, the Class II collagenases (δ, ε, and ζ,) are products of colH gene, their initial cleavage sites are located within the interior of the collagen molecule and generate smaller collagen fragments. 
Nasprotno pa so kolagenaze razreda II (δ, ε, in ζ,) produkti gena colH, njihova cepilna mesta se nahajajo znotraj kolagenske molekule in proizvajajo manjše kolagenske fragmente.
Tell your doctor if you have previously received or are thinking about receiving Xiapex to treat a condition known as Peyronie's disease. 
Zdravniku povejte, če ste že prejemali ali razmišljate o prejemanju zdravila Xiapex za zdravljenje bolezni, imenovane Peyroniejeva bolezen.
See Figure 1 below for an illustration of the injection technique. 
spodaj za prikaz tehnike injiciranja.
Injection of Xiapex into a Dupuytren's cord, which is comprised mostly of interstitial collagen types I and III, results in enzymatic disruption of the cord. 
Injiciranje zdravila Xiapex v Dupuytrenov vozlič, ki je večinoma sestavljen iz intersticijskega kolagena tipa I in III, povzroči encimsko prekinitev vozliča.
The goal is to gradually create bending opposite to the patient's penile curvature, with stretching to the point of moderate resistance. 
Cilj je, da se z raztezanjem do točke zmernega odpora postopno ustvari upognjenost, ki je nasprotna bolnikovi ukrivljenosti penisa.
The vial containing the solution should not be inverted or shaken. 
Viale, ki vsebuje raztopino, ne smete obračati ali tresti.
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. 
Ob izhodišču je bil povprečni (SD) seštevek PDQ za ženske 4,7 (3,61), v 36. tednu pa 2,7 (3,06), tj. sprememba od izhodišča za -2,0.
The volume of reconstituted Xiapex to be administered into the plaque is 0.25 ml (for reconstitution instructions, see section 6.6, Table 14). 
Volumen rekonstituiranega zdravila Xiapex, ki ga bomo dali v plak, je 0,25 ml (za navodila glede rekonstitucije glejte poglavje 6.6, preglednico 14).
Class I cleaves insoluble triple helical collagen with higher affinity than Class II collagenase. 
Razred I cepi netopno trojno spiralo kolagena z večjo afiniteto kot kolagenaze razreda II.
Do not have sex or have any other sexual activity for at least 4 weeks after the second injection of a treatment cycle with Xiapex and after any pain and swelling has ceased and be cautious when resuming sexual activity. 
Spolnega odnosa ali drugih spolnih aktivnosti ne smete imeti vsaj 4 tedne po drugi injekciji v ciklu zdravljenja z zdravilom Xiapex in po izginotju vsakršne bolečine in otekline ter bodite previdni, ko postanete ponovno spolno aktivni.
(degrees) 
(stopinje)
0.25 ml †Note that injection volume for delivery of a 0.58 mg dose is less than the total volume of solvent used for reconstitution. 
0,25 ml †Volumen injekcije za prenos odmerka 0,58 mg je manjši kot skupni volumen vehikla, uporabljenega za rekonstitucijo.
Most patients experiencing tendon/ligament rupture or injury have gone on to have successful surgical repair. 
Pri večini bolnikov so rupturo kite/ligamenta ali poškodbo uspešno kirurško zdravili.
The majority of adverse events reported during the long-term follow-up period were non-serious, mild or moderate in intensity, and were not related to the local administration of Xiapex. 
Večina neželenih učinkov, o katerih so poročali v dolgoročnem obdobju spremljanja, ni bilo resnih in so bili po intenzivnosti blagi ali zmerni ter nepovezani z lokalnim apliciranjem zdravila Xiapex.
Physician-rated change in contracture severity was reported as very much improved or much improved in 86% and 80% of the subjects in the Xiapex group compared to 3% and 5% of subjects in the placebo group for the CORD I and CORD II studies, respectively (p<0.001). 
Zdravnikova ocena spremembe resnosti kontrakture je bila poročana kot zelo izboljšano stanje ali precej izboljšano stanje v 86 % in 80 % preskušancev v skupini z zdravilom Xiapex v primerjavi s 3 % in 5 % preskušancev v skupini placebo za študiji CORD I in CORD II (p < 0,001).
If the first finger extension procedure does not result in disruption of the cord, a second and third attempt can be performed at 5- to 10-minute intervals. 
Če po prvem postopku iztegovanja prstov ne pride do prekinitve vozliča, se lahko v 5 do 10-minutnih intervalih postopek ponovi še drugič ali tretjič.
The double-blind study population comprised 832 male patients of whom 551 patients received Xiapex and 281 received placebo. 
Populacijo dvojno slepe študije je sestavljalo 832 moških bolnikov, od katerih je 551 bolnikov prejemalo zdravilo Xiapex in 281 jih je prejemalo placebo.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
• The treatment of Dupuytren's contracture in adult patients with a palpable cord. 
• zdravljenje Dupuytrenove kontrakture pri odraslih bolnikih z otipljivim vozličem.
Solvent required for reconstitution 
Vehikel, potreben za rekonstitucijo
The second Xiapex injection is administered 1 to 3 days after the first injection. 
Druga injekcija zdravila Xiapex se injicira 1 do 3 dni po prvi injekciji.
• Proper amount of volumes for both reconstitution and injection differences in the metocarpophalangeal (MP) and proximal interphalangeal (PIP) joints for Dupuytren's contracture and for the Peyronie's disease plaque. 
• ustrezne količine rekonstitucijske tekočine in tekočine za injiciranje, ki so različne za metakarpofalangealne (MP) in proksimalne interfalagealne (PIP) sklepe, za Dupuytrenovo kontrakturo in plak Peyroniejeve bolezni,
When administering two injections in the same hand during a treatment visit, use a new syringe and separate vial of reconstituted solution (containing 0.58 mg of Xiapex) for the second injection. 
Pri dajanju dveh injekcij v isto roko med obiskom za zdravljenje je treba uporabiti novo injekcijsko brizgo in ločeno vialo z rekonstituirano raztopino (ki vsebuje 0,58 mg zdravila
If the needle is in the proper location, there will be some resistance noted during the injection procedure. 
Če je igla na pravilnem mestu, boste med injiciranjem čutili malo upora.
Care should be taken when injecting Xiapex into cords contracting the PIP joints as clinical studies indicate an increased risk of tendon rupture and ligament injury associated with treatment of PIP contractures with Xiapex. 
Previdnost je potrebna pri injiciranju zdravila Xiapex v kontrakcijske vozliče PIP sklepov, saj klinične študije kažejo povečano tveganje rupture kite in poškodbe ligamenta, povezane z zdravljenjem kontraktur PIP sklepov z zdravilom Xiapex.
Again keeping the needle under the skin at all times, withdraw the needle tip from the cord and reposition it a third time proximal to the initial injection (approximately 2-3 mm) and inject the final portion of the dose into the cord (see Figure 2). 
Ponovno pazite, da je igla ves čas pod kožo, in ponovno izvlecite konico igle iz vozliča ter jo namestite proksimalno od prvotnega mesta injiciranja (približno 2 do 3 mm) in injicirajte še zadnjo tretjino odmerka v vozlič (glejte sliko 2).
A penile modelling procedure is performed 1 to 3 days after the second injection of each treatment cycle. 
Postopek modeliranja penisa se opravi 1 do 3 dni po drugi injekciji vsakega cikla zdravljenja.
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. 
Vključitvena in izključitvena merila za študijo, pa tudi režim zdravljenja ter sočasni primarni opazovani dogodki, so bili enaki kot v ključnih študijah AUX-CC-803 in AUX-CC-804.
• Perform a series of finger flexion and extension exercises several times a day for several months. 
• naj izvajajo serije vaj upogibanja in iztegovanja prstov večkrat dnevno več mesecev.
Xiapex must be reconstituted with the solvent provided and to the appropriate volume prior to intralesional injection (see section 6.6). 
Zdravilo Xiapex je treba pred intralezijsko injekcijo rekonstituirati do primernega volumna z vehiklom, ki je priložen (glejte poglavje 6.6).
Xiapex must only be injected into the Dupuytren's cord. 
Zdravilo Xiapex je treba injicirati samo v Dupuytrenov vozlič.
Peyronie's disease occurs exclusively in adult male patients and hence there is no relevant use of Xiapex in the paediatric population aged 0-18 years for the treatment of Peyronie's disease. 
Peyroniejeva bolezen se pojavlja samo pri odraslih moških bolnikih, zato zdravilo Xiapex ni primerno za uporabo pri pediatrični populaciji, stari od 0-18 let, za zdravljenje Peyroniejeve bolezni.
The incidence of Xiapex-associated pruritus was similar after each injection regardless of the number of injections administered. 
Incidenca pruritusa, povezanega z zdravilom Xiapex, je bila po vsaki injekciji podobna, ne glede na število danih injekcij.
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). 
Med kliničnimi študijami so večkrat testirali krvne vzorce bolnikov z Dupuytrenovo kontrakturo in Peyroniejevo boleznijo na prisotnost protiteles proti beljakovinskim komponentam zdravila (AUX-I in AUX-II).
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. 
Ponovitev je bila ocenjevana v uspešno zdravljenih sklepih (tj. osebe so imele zmanjšanje kontrakture na 5° ali manj na 30. dan ocenitve po zadnji injekciji zdravila Xiapex v predhodni študiji) in je bila definirana kot zvečanje kontrakture sklepa na vsaj 20° v prisotnosti otipljivega vozliča, ali pa je bil na sklepu opravljen zdravniški ali operativni poseg, primarno za korekturo nove ali poslabšane
Table 1 presents adverse reactions listed by system organ class and frequency categories, using the following convention: very common (≥1/10), common (≥1/100 to <1/10), and uncommon (≥1/1,000 to <1/100), and not known: cannot be estimated from the available data. 
V preglednici 2 so predstavljeni neželeni učinki, našteti po organskih sistemih in kategorijah pogostnosti po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100) in neznana pogostnost: ni mogoče oceniti iz razpoložljivih podatkov.
c) Administer suitable local anaesthetic, if desired. 
c) Po želji uporabite ustrezni lokalni anestetik.
If cords of two affected joints in one finger were treated, perform the finger extension procedure on the cord affecting the MP joint before performing the procedure on the cord affecting the PIP joint. 
Če zdravite vozliča dveh prizadetih sklepov enega prsta, izvedite postopek iztegovanja prstov na vozliču, ki je prizadel MP sklep, preden postopek izvedete na vozliču, ki je prizadel PIP sklep.
Injection of Xiapex into a Peyronie's plaque, which is comprised mostly of collagen, may result in enzymatic disruption of the plaque. 
Injiciranje zdravila Xiapex v Peyroniejev plak, ki je večinoma sestavljen iz kolagena, lahko povzroči encimsko prekinitev plaka.
• abnormal sensation 
• nenormalen občutek
The solvent that is used to dissolve the powder is a clear colourless liquid. 
Vehikel, ki se uporablja za raztapljanje praška, je prosojna brezbarvna tekočina.
Corporal rupture was reported as a serious adverse reaction after Xiapex injection in 5 out of 1044 patients (0.5%) in the controlled and uncontrolled clinical trials in Peyronie's disease. 
O rupturi korpusa so poročali kot o resnem neželenem učinku po injiciranju zdravila Xiapex pri 5 od 1.044 bolnikov (0,5 %) v nadzorovanih in nenadzorovanih kliničnih preskušanjih pri Peyroniejevi bolezni.
With the other hand, hold the base of your penis with the fingers (see Figure 3). 
S prsti druge roke držite koren penisa (glejte sliko 3).
In the Peyronie's disease clinical studies, at 6 weeks after the first treatment cycle of Xiapex, approximately 75% of patients had antibodies against AUX-I and approximately 55% of patients had antibodies against AUX-II. 
V kliničnih študijah Peyroniejeve bolezni je imelo 6 tednov po prvem ciklu zdravljenja z zdravilom Xiapex približno 75 % bolnikov protitelesa proti AUX-I in približno 55 % bolnikov je imelo protitelesa proti AUX-II.
Withdraw the needle slowly so as to deposit the full dose along the needle track within the plaque. 
Iglo počasi izvlecite tako, da celoten odmerek vnašate vzdolž poti igle znotraj plaka.
The reduction in the Bother domain score was numerically similar between patient groups stratified by degree of baseline curvature deformity (30 to 60 degrees and 61 to 90 degrees). 
Zmanjšanje rezultata Področja težav je bilo v številkah podobno med skupinama bolnikov, stratificiranima po stopnji deformacije ukrivljenosti ob izhodišču (30 do 60 stopinj in 61 do 90 stopinj).
• The other ingredients are sucrose, trometamol and hydrochloric acid 2.4% w/w (for pH 
• Pomožne snovi so saharoza, trometamol in klorovodikova kislina 2,4 % w/w (za uravnavanje pH).
Improvement of the total fixed flexion contracture was also observed irrespectively of the time of finger extension, 24, 48 or 72 hours after injection, with a mean improvement at Day 31 of 75.2% 74.8% and 72.4% respectively. 
24, 48 oz. 72 ur po injekciji, s povprečnim izboljšanjem 31. dne za 75,2 %, 74,8 % oz. 72,4 %.
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”. 
Če vam bo zdravnik kljub majhni verjetnosti dal večji odmerek od priporočenega, se utegnejo pojaviti resnejši neželeni učinki, ki so navedeni v poglavju 4 »Možni neželeni učinki« tega navodila za uporabo.