natgillin/translations-raw huggingface dataset:
Neutralizing antibodies to AUX-I or AUX-II, were detected in 60% and 51.8%, respectively, of patients tested. 
Nevtralizirajoča protitelesa proti AUX-I so odkrili pri 60 % , proti AUX-II pa pri 51,8 % testiranih bolnikov.
The target plaque is used as a fulcrum point with both hands, to firmly apply a steady pressure to elongate and stretch the plaque. 
Ciljni plak služi kot vzvodna točka, na katero se z obema rokama izvaja čvrst stalen pritisk in s tem podaljšuje in razteza plak.
In addition, patients were instructed to perform penile modelling at home for six weeks after each treatment cycle. 
Poleg tega so bolnikom naročili, naj šest tednov po vsakem ciklu zdravljenja doma izvajajo modeliranje penisa.
If the solution contains particulates, is cloudy, or is discoloured, do not inject the reconstituted solution. 
Če raztopina vsebuje delce, je motna ali obarvana, ne injicirajte rekonstituirane raztopine.
In each treatment cycle, two injections of Xiapex 0.58 mg or two injections of placebo were administered 1 to 3 days apart. 
V vsakem ciklu zdravljenja so bolniki dobili dve injekciji zdravila Xiapex 0,58 mg ali dve injekciji placeba z razmikom 1 do 3 dni.
In a single-dose phase or 61-day repeat-dose phase (3 times a week every 3 weeks for 3 cycles) study of intrapenile administration of collagenase clostridium histolyticum in dogs at exposures lower than or equal to the maximum recommended human dose on a mg/m2 basis, there was no evidence of systemic toxicity. 
V študiji intrapenilnega dajanja kolagenaze clostridium histolyticum psom v fazi enega odmerka ali v fazi 61-dnevnega ponavljajočega odmerjanja (3 cikli po 3-krat na teden vsake 3 tedne) pri izpostavljenostih, nižjih ali enakih največjemu priporočenemu odmerku pri ljudeh na podlagi mg/m2, ni bilo znakov sistemske toksičnosti.
• 0.39 ml of solvent for the penile plaque in Peyronie's disease e) Inject the diluent slowly into the sides of the vial containing the lyophilized powder of Xiapex. 
• 0,39 ml vehikla za plak penisa pri Peyroniejevi bolezni e) Vehikel počasi injicirajte ob steno viale, ki vsebuje liofiliziran prašek zdravila Xiapex.
For joints reported as recurring in a previous study, the day of recurrence was the first visit with a fixed flexion contracture measurement of 20° or greater following the report of recurrence. 
Za sklepe, pri katerih je bila ponovitev poročana v prejšnji študiji, je bil dan ponovitve prvi obisk s popravljeno izmerjeno fleksijsko kontrakturo
The diluent contains calcium which is required for the activity of Xiapex. 
Vehikel vsebuje kalcij, ki je potreben za delovanje zdravila Xiapex.
A study AUX-CC-862 was conducted in patients with Dupuytren's contracture who had recurrence of contracture in a joint that was effectively treated with Xiapex in a previous clinical study. 
Študijo AUX-CC-862 so izvedli pri bolnikih z Dupuytrenovo kontrakturo, ki se jim je kontraktura ponovila v sklepu, ki je bil v predhodni klinični študiji učinkovito zdravljen z zdravilom Xiapex.
Diagnostic imaging is recommended after manipulation if finger deformity, pain or increased swelling develops (see also section 4.8). 
Če se po obravnavi razvije deformacija prsta, bolečina ali povečana oteklina, se priporoča diagnostično slikanje (glejte tudi poglavje 4.8).
Xiapex is comprised of a mixture of Class I (AUX-I) and Class II (AUX-II) clostridial collagenases in a defined mass ratio. 
Zdravilo Xiapex sestavlja mešanica razreda I (AUX-I) in razreda II (AUX-II) klostridijskih kolagenaz v določenem masnem razmerju.
If your cord to be treated is attached to the skin, you are at higher risk of the skin splitting or tearing during the finger extension procedure following the injection of Xiapex. 
Če je vozlič, ki vam ga bodo zdravili, pričvrščen na kožo, obstaja večje tveganje, da bo prišlo do prebodenja ali raztrganja kože med postopkom iztegovanja prstov, ki sledi injiciranju zdravila Xiapex.
Call your doctor right away if you experience any of the symptoms of penile fracture or serious injury to your penis listed above, as this may require surgical intervention. 
Takoj pokličite zdravnika, če se pojavijo kateri koli simptomi zloma penisa ali resne poškodbe penisa, naštete zgoraj, saj bi bil zaradi tega morda lahko potreben kirurški poseg.
A penile modelling procedure was performed on patients at the study site 1 to 3 days after the second injection of the cycle. 
Postopek modeliranja penisa je bil opravljen pri bolnikih na mestu poteka študije 1 do 3 dni po drugem injiciranju v ciklu.
Elevate the injected hand as much as possible until the day after the finger extension procedure. 
Zdravljeno roko držite dvignjeno, kolikor je možno, do dneva po postopku iztegovanja prstov.
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. 
Za vsako osebo, za katero je bil izbran vzorec iz 12. tedna, so bili testirani tudi ustrezni vzorci iz 6., 18., 24. in
Tables 11-12 provide the results of the co-primary efficacy endpoints measured in the open label phase 3 study AUX-CC-806. 
V preglednicah 11-12 so rezultati sočasnih primarnih opazovanih dogodkov učinkovitosti, izmerjenih v odprti študiji 3. faze, AUX-CC-806.
Receiving an injection of Xiapex may cause damage to the tubes in your penis called the corpora. 
Injiciranje zdravila Xiapex lahko poškoduje cevke v penisu, imenovane korpusi.
Absorption Following administration of either a single dose of 0.58 mg of Xiapex to 16 patients with Dupuytren's contracture, or two concurrent injections of 0.58 mg of Xiapex in the same hand in 12 patients with Dupuytren's contracture, no quantifiable levels of Xiapex were detected in plasma from 5 minutes to 30 days post injection. 
Absorpcija Po aplikaciji bodisi enkratnega odmerka 0,58 mg zdravila Xiapex 16 bolnikom z Dupuytrenovo kontrakturo ali dveh sočasnih injekcij po 0,58 mg zdravila Xiapex v isto roko 12 bolnikom z Dupuytrenovo kontrakturo v času od 5 minut do 30 dni po injiciranju ni bilo zaznati merljivih nivojev zdravila Xiapex v plazmi.
• After a 30 second rest period, repeat the penile modelling technique for a total of 3 modelling attempts at 30 seconds for each attempt. 
• Nato ga sprostite in počakajte 30 sekund, preden tehniko modeliranja penisa ponovite, in sicer skupaj izvedite 3 poskuse s po 30 sekundami za vsak poskus.
Baseline disease characteristics of patientsa with Peyronie's Disease (PD) 
Značilnosti bolezni ob izhodišču pri bolnikiha s Peyroniejevo boleznijo (PB)
This is a condition where adult men have a ‘plaque' that can be felt and a curve to their penis. 
To je bolezen, pri kateri imajo odrasli moški ‘plak', ki se ga lahko otipa, in ukrivljenost penisa.
• 0.25 ml of reconstituted Xiapex for cords affecting a MP joint or • 0.20 ml of reconstituted Xiapex for cords affecting a PIP joint. 
• 0,25 ml rekonstituiranega zdravila Xiapex za vozliče, ki prizadenejo MP sklep, ali • 0,20 ml rekonstituiranega zdravila Xiapex za vozliče, ki prizadenejo PIP sklep.
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. 
Splošni varnostni profil je bil podoben v dveh dvojno slepih, s placebom nadzorovanih študijah 3. faze (832 bolnikov moškega spola, 551 bolnikov je prejemalo zdravilo Xiapex) in v odprti študiji 3. faze (189 bolnikov moškega spola) pri bolnikih, ki so predhodno v nadzorovanih študijah prejemali placebo.
Severe penile haematoma was also reported as an adverse reaction in 39 of 1044 patients (3.7%) in the controlled and uncontrolled clinical studies in Peyronie's disease. 
O hudem hematomu penisa kot neželenem učinku so poročali pri 39 od 1.044 bolnikov (3,7 %) v nadzorovanih in nenadzorovanih kliničnih študijah pri Peyroniejevi bolezni.
Xiapex also demonstrated a clinically significant benefit compared to placebo in decreasing the degree of contracture and increasing both the range of motion from baseline for all joints treated (MP plus PIP, MP only, PIP only) and the subject global assessment of treatment satisfaction. 
Zdravilo Xiapex je pokazalo tudi klinično pomembne koristi v primerjavi s placebom pri zmanjšanju stopnje kontrakture in zvečanju razpona gibanja glede na izhodišče za vse zdravljene sklepe (MP in PIP, samo MP, samo PIP), kot tudi pri globalni oceni zadovoljnosti z zdravljenjem preskušanca.
The syringe and needle used for reconstitution are thereafter removed and discarded. 
Brizgo in iglo, ki ste ju uporabili za rekonstitucijo, potem odstranite in zavrzite.
Avoid having the needle tip pass completely through the cord to help minimise the potential for injection of Xiapex into tissues other than the cord. 
Poskušajte se izogniti temu, da bi s konico igle prebodli vozlič, da zmanjšate možnost injiciranja zdravila Xiapex v druga tkiva.
• blood pressure increased 
• zvišanje krvnega tlaka
Peyronie's disease: The treatment area should be identified and marked with a surgical marker on the erected penis. 
Peyroniejeva bolezen: predel zdravljenja morate določiti na nabreklem penisu in ga označiti s kirurškim markerjem.
Pre-existing reduced peripheral circulation, e.g. Raynaud syndrome, and the use of epinephrine combined with local anaesthetics in these patients may contribute to this (see also section 4.8). 
npr. Raynaudov sindrom, in uporaba adrenalina v kombinaciji z lokalnimi anestetiki (glejte tudi poglavje 4.8).
b “skin laceration” includes “injection site laceration” and “laceration” c “oedema peripheral” includes “injection site oedema” and “oedema” d see also section 4.4 
c “periferni edem” vključuje “edem na mestu injiciranja” in “edem” d glejte tudi poglavje 4.4
Primary efficacy endpoint was fixed flexion contracture in the treated joint pair subgroup. 
Primarni opazovani dogodek učinkovitosti je bila popravljena fleksijska kontraktura v podskupini zdravljenega para sklepov.
• increased liver enzymes 
• povečane vrednosti jetrnih encimov;
Cases of digital phalangeal fractures have been reported after finger manipulation procedure. 
Poročali so o primerih falangealnih zlomov po postopku obravnave prstov.
PDQ bother** 
Težave zaradi PDQ**
Xiapex is supplied in a pack containing 1 vial of Xiapex powder and 1 vial of solvent. 
Zdravilo Xiapex je na voljo v pakiranju, ki vsebuje po 1 vialo praška zdravila Xiapex in 1 vialo z vehiklom.
At a follow-up visit 1 to 3 days after the second injection of each treatment cycle, perform a penile modelling procedure (as described below) on the flaccid penis to stretch and elongate the plaque that Xiapex has disrupted: 
Ob kontrolnem obisku 1 do 3 dni po drugi injekciji vsakega cikla zdravljenja opravite postopek modeliranja penisa (kot je opisano spodaj) pri mlahavem penisu, da zdravljeni plak, ki ga je zdravilo Xiapex prekinilo, raztezate in podaljšate:
When injecting a cord affecting a PIP joint of the fifth finger, the needle insertion must not be more than 2 to 3 mm in depth and not more than 4 mm distal to the palmar digital crease. 
Kadar injiciramo v vozlič PIP sklepa petega prsta, vbod z iglo ne sme biti globlji od 2 do 3 mm in mora biti oddaljen manj kot 4 mm distalno od palmarne gube.
The mITT population was defined as all randomized subjects who had both a penile curvature deformity measurement and a PDQ assessment at baseline and at one or more subsequent time points. 
Populacija mITT je bila opredeljena kot vse randomizirane osebe, ki so imele izmerjeno deformacijo ukrivljenosti penisa in oceno PDQ ob izhodišču in na eni ali več naslednjih časovnih točkah.
Please consult a doctor immediately if you experience any signs or symptoms of a serious allergic reaction, e.g., wide spread redness or rash, swelling, tightness in the throat or difficulty breathing. 
Nemudoma se posvetujte s svojim zdravnikom, če se pri vas pojavijo kakršnikoli znaki ali simptomi resnih alergijskih reakcij, npr. rdečina ali izpuščaj po celem telesu, oteklina, tiščanje v žrelu ali težave pri dihanju.
Xiapex is injected by your doctor into the cord in your finger/hand or plaque in your penis and works by breaking down the collagen in the cord or plaque. 
Zdravilo Xiapex vam zdravnik injicira v vozlič v prstu/roki ali v plak v penisu in deluje tako, da razgrajuje kolagen v vozliču ali plaku.
Xiapex is a lyophilized product for parenteral administration containing collagenase clostridium histolyticum which is comprised of two collagenases in a defined mass ratio. 
Zdravilo Xiapex je liofiliziran izdelek za parenteralno aplikacijo, ki vsebuje kolagenazo clostridium histolyticum, ki jo sestavljata dve kolagenazi v določenem masnem razmerju.
Xiapex should be injected into the target plaque when the penis is in a flaccid state. 
Zdravilo Xiapex je treba injicirati v ciljni plak, ko je penis v mlahavem stanju.
• collection of blood outside of a blood vessel on scrotum 
• kopičenje krvi zunaj krvne žile na skrotumu
1 vial of solvent 
1 viala vehikla
Following the finger extension procedure(s) and fitting patient with a splint (with treated joint in maximum extension), patients should be instructed to: 
Po postopku (postopkih) iztegovanja prstov in namestitvi opornice bolniku (z zdravljenim sklepom v maksimalni ekstenziji) je treba bolnikom naročiti:
Total FFC (°) 
Skupaj PFK (°)
At five years after the initial injection of Xiapex the majority of subjects (>90%) were seropositive for anti-AUX-I and anti-AUX-II antibodies. 
Pet let po začetni injekciji zdravila Xiapex je bila večina oseb (> 90 %) seropozitivnih za protitelesa proti AUX-I in proti AUX-II.
Xiapex demonstrated a clinically significant benefit compared to placebo in the proportion of patients achieving the primary endpoint of a reduction in the contracture of all joints treated to 5° or less, approximately 4 weeks after the last injection (MP plus PIP, MP only, PIP only). 
Zdravilo Xiapex je pokazalo klinično pomembne koristi v primerjavi s placebom v deležu bolnikov, ki so dosegli primarni opazovan dogodek zmanjšanja kontrakture vseh zdravljenih sklepov na 5° ali manj, približno 4 tedne po zadnjem injiciranju (MP in PIP, samo MP, samo PIP).
AUX-I and AUX-II are single polypeptide chains consisting of approximately 1000 amino acids of known sequence with a molecular weight of 114 kDa and 113 kDa respectively as determined by mass spectrometry. 
Kot je ugotovljeno z masno spektrometrijo sta AUX-I in AUX-II enojni polipeptidni verigi, ki ju sestavlja približno 1.000 aminokislin znanega zaporedja, z molekulskimi masami 114 kDa in 113 kDa.
A finger extension procedure was performed if needed, approximately 24 hours after injection to facilitate disruption of the cord. 
Če je bilo to potrebno, je bil napravljen postopek iztegovanja prsta, približno 24 ur po injiciranju, da je bila olajšana prekinitev vozliča.
The European Medicines Agency has waived the obligation to submit the results of studies with Xiapex in all subsets of the paediatric population in the treatment of Dupuytren's contracture (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Xiapex za zdravljenje Dupuytrenove kontrakture za vse podskupine pediatrične populacije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Injections in up to two cords or two affected joints in the same hand can be administered according to the injection procedure during a treatment visit. 
Injiciranje v do dva vozliča ali dva prizadeta sklepa iste roke je možno v skladu s postopkom injiciranja med obiskom za zdravljenje.
This medicine must only be injected into the collagen cord in your hand by your doctor. 
To zdravilo vam lahko zdravnik injicira samo v kolagenski vozlič v roki.
There were no other clinically relevant differences between two concurrent injections of Xiapex in the same hand and up to three single injections of Xiapex in the types of adverse events reported (i.e., most adverse events were local to the treated extremity and of mild or moderate intensity). 
Drugih klinično pomembnih razlik med dvema sočasnima injekcijama zdravila Xiapex v isto roko in do tremi enkratnimi injekcijami zdravila Xiapex med vrstami poročanih neželenih učinkov ni bilo (tj. večina neželenih učinkov je bilo lokalnih v zdravljeni okončini in blage do zmerne intenzivnosti).
If the disease has resulted in multiple contractures, additional cords may be treated at other treatment visits approximately 4 weeks apart. 
Če je bolezen povzročila več kontraktur, je možno dodatne vozliče zdraviti ob drugih obiskih za zdravljenje s približno 4-tedenskim časovnim zamikom.
b p-value < 0.05. 
b vrednost p < 0,05
Patients with Dupuytren's contractures that adhere to the skin may be at higher risk of skin lesions as a result of the pharmacological effect of Xiapex and the finger extension procedure on the skin overlying the targeted cord. 
Bolniki z Dupuytrenovimi kontrakturami, ki se držijo kože, imajo večje tveganje za kožne spremembe na koži, ki leži nad tarčnim vozličem, kot posledica farmakoloških učinkov zdravila Xiapex in postopka iztegovanja prsta.
Injections and finger extension procedures may be administered up to 3 times per cord at approximately 4-week intervals. 
Injekcije in postopek iztegovanja prstov se sme ponoviti do trikrat na posamezen vozlič v približno 4-tedenskih intervalih.
The site chosen for injection must be the area where the contracting cord is maximally separated from the underlying flexor tendons and where the skin is not intimately adhered to the cord. 
Mesto injiciranja mora biti izbrano tako, da je v predelu, kjer je kontrakcijski vozlič najbolj oddaljen od spodaj ležečih kit upogibalk in kjer koža ni pričvrščena neposredno na vozlič.
Following each of two intralesional administrations, separated by 24 hours, of Xiapex 0.58 mg into the penile plaque of 19 patients with Peyronie's disease, plasma levels of AUX-I and AUX-II in patients with quantifiable levels (82% and 40% for AUX-I and AUX-II, respectively) were minimal and shortlived. 
Po dveh intralezijskih aplikacijah 0,58 mg zdravila Xiapex v plak penisa pri 19 bolnikih s Peyroniejevo boleznijo s 24-urnim presledkom, so bile ravni AUX-I in AUX-II v plazmi pri bolnikih z merljivimi ravnmi (82 % za AUX-I in 40 % za AUX-II) minimalne in kratkotrajne.
There is no relevant use of Xiapex in children and adolescents aged 0-18 years for the treatment of Dupuytren's contracture or Peyronie's disease. 
Zdravilo Xiapex ni primerno za uporabo pri otrocih in mladostnikih, starih 0-18 let, za zdravljenje Dupuytrenove kontrakture ali Peyroniejeve bolezni.
For Peyronie's disease, Xiapex breaks down the collagen in the plaque that is causing your erect penis to curve, which may help the previously bent erection to become straighter and enable you to feel less bothered by your disease. 
Pri Peyroniejevi bolezni zdravilo Xiapex razgradi kolagen v plaku, ki povzroča ukrivljenost penisa med erekcijo, in lahko pomaga predhodno upognjeni erekciji, da postane bolj ravna, ter lajšanju težav,
Figure 3: Illustration how to stretch your penis 
Slika 3: Prikaz raztezanja penisa
Injection of Xiapex into collagen containing structures may result in damage to those structures, and possible permanent injury such as tendon rupture or ligament damage. 
Injiciranje zdravila Xiapex v strukture, ki vsebujejo kolagen, utegne poškodovati te strukture in povzročiti trajno poškodbo, na primer rupturo kite ali poškodbo ligamenta.
• swollen face 
• oteklina obraza
• skin wound at the site of injection 
• kožna rana na mestu injiciranja;
Six weeks after the eighth injection (fourth treatment cycle) of Xiapex >99% of Xiapex-treated patients developed high titers of antibodies to both AUX-I and AUX-II. 
Šest tednov po osmi injekciji (četrti cikel zdravljenja) zdravila Xiapex je > 99 % bolnikov, zdravljenih z zdravilom Xiapex, razvilo visoke titre protiteles proti AUX-I in
• skin wound, blood blister 
• kožna rana, krvav mehur;
Do not invert the vial or shake the solution. 
Viale ne obračajte in ne stresajte raztopine.
The active substance in Xiapex is collagenase clostridium histolyticum, and this collagenase is produced using the microorganism Clostridium histolyticum. 
Učinkovina v zdravilu Xiapex je encim kolagenaza clostridium histolyticum in ta kolagenaza se proizvaja s pomočjo mikroorganizma Clostridium histolyticum.
If the disease has resulted in multiple contractures, additional cords may be treated at other treatment visits approximately 4 weeks apart, as determined by your doctor. 
Če se bolezen kaže s številnimi kontrakturami, se lahko dodatni vozliči zdravijo ob drugih obiskih za zdravljenje s približno 4-tedenskim časovim zamikom, kot bo določil zdravnik.
Approximately 24-72 hours after injection, a finger extension procedure may be performed, as necessary, to facilitate cord disruption. 
Približno 24 - 72 ur po injiciranju lahko začnete izvajati postopek iztegovanja prstov, kot bo potrebno, da boste pospešili prekinitev vozliča.
• collection of blood outside the blood vessels 
• kopičenje krvi zunaj krvnih žil
Administration of a local anaesthetic medicinal product prior to injection of Xiapex is not recommended, as it may interfere with proper placement of the injection. 
Aplikacija lokalnega anestetika pred injiciranjem zdravila Xiapex ni priporočljiva, ker lahko vpliva na primeren položaj injiciranja.
Some patients with Dupuytren's contracture developed IgE-anti-drug antibodies in greater proportions and higher titers with successive Xiapex injections. 
Pri nekaterih bolnikih z Dupuytrenovo kontrakturo so se razvila protitelesa IgE proti zdravilu v večjem deležu in z višjimi titri pri naknadnih injekcijah zdravila Xiapex.
There is no experience in the use of Xiapex in breast-feeding women therefore the use of Xiapex is not recommended during breast-feeding. 
Izkušenj z uporabo zdravila Xiapex pri doječih ženskah ni, zato se uporaba zdravila Xiapex med dojenjem ne priporoča.
Dupuytren's contracture: The joint to be treated (MP or PIP) should be confirmed as the volume of solvent required for reconstitution is determined by the type of joint (PIP joint requires a smaller volume for injection). 
Dupuytrenova kontraktura: sklep, ki ga boste zdravili (MP ali PIP), je treba potrditi, saj je volumen vehikla, ki je potreben za rekonstitucijo, določen glede na vrsto sklepa (za PIP sklep je potreben manjši volumen za injiciranje).
• painful glands near the elbows or under the arm 
• boleče bezgavke blizu komolca ali pod pazduho;
While the patient's wrist is in the flexed position, a moderate stretching pressure should be applied to the injected cord by extending the finger for approximately 10 to 20 seconds. 
Ko je bolnikovo zapestje v skrčenem položaju, je treba izvajati zmeren raztezni pritisk na injicirani vozlič tako, da za približno 10 do 20 sekund iztegujete prst.
With your dominant hand, place the needle into the cord, using caution to keep the needle within the cord. 
S svojo dominantno roko namestite iglo v vozlič in pazite, da bo ostala v vozliču.
At the follow-up visit approximately 24-72 hours after injection, it should be determined if the contracture has resolved. 
Na kontrolnem obisku približno 24 - 72 ur po injiciranju je treba preveriti, ali je kontraktura odpravljena.
There was no evidence of accumulation following two sequential injections of Xiapex administered 24 hours apart. 
Znakov kopičenja po dveh zaporednih injekcijah zdravila Xiapex s 24-urnim presledkom ni bilo.
No formal medicinal product interaction studies with Xiapex have been performed. 
Študij medsebojnega delovanja zdravila Xiapex z drugimi zdravili niso izvedli.
• fever, general pain, discomfort, tiredness, feeling hot, malaise, flu-like illness 
• vročina, splošna bolečina, nelagodje, utrujenost, občutek vročine, splošno slabo počutje,