natgillin/translations-raw huggingface dataset:
In addition to the in-office penile modelling procedure, patients should be provided instructions on the appropriate technique to self-perform penile modelling activities at home each day for the 6-week period following the physician penile plaque modelling visit of each treatment cycle, according to the detailed instructions provided in the package leaflet. 
Poleg ambulantnega postopka modeliranja penisa je treba bolnikom dati navodila za ustrezno tehniko za samoizvajanje aktivnosti modeliranja penisa doma, vsak dan za obdobje 6 tednov po obisku vsakega cikla zdravljenja, na katerem zdravnik opravi modeliranje plaka penisa, v skladu s podrobnimi navodili iz navodila za uporabo.
Mean percent change in penile curvature deformity from baseline to week 52 - Studies 1 and 2 
Povprečna sprememba deformacije ukrivljenosti penisa v odstotkih od izhodišča do 52. tedna - študiji 1 in 2 Študija 1
While the patient's wrist is in the flexed position, apply moderate stretching pressure to the injected cord by extending the finger for approximately 10 to 20 seconds. 
Ko je bolnikovo zapestje v skrčenem položaju, izvajajte zmeren raztezni pritisk na injiciran vozlič tako, da za približno 10 do 20 sekund iztegujete prst.
Apply antiseptic at the site of the injection and allow the skin to dry. 
Na mesto injiciranja nanesite antiseptik in počakajte, da se koža osuši.
There is no experience in the use of Xiapex in pregnant women therefore the use of Xiapex is not recommended in pregnancy, and treatment should be postponed until after pregnancy. 
Izkušenj z uporabo zdravila Xiapex pri nosečnicah ni, zato uporaba zdravila Xiapex v času nosečnosti ni priporočljiva in je treba zdravljenje odložiti na čas po nosečnosti.
A phase 4, non-treatment, long-term follow-up study (AUX-CC-810) was undertaken to evaluate the efficacy and safety up to 5 years after the first injection of Xiapex in the pivotal 12-month doubleblind placebo-controlled phase 3 studies or in the 9-month open-label phase 3 studies. 
Izvedli so dolgoročno študijo spremljanja brez zdravljenja, 4. faze, (AUX-CC-810), s katero so ocenili učinkovitost in varnost do 5 let po prvi injekciji zdravila Xiapex v ključnih 12-mesečnih dvojno slepih, s placebom nadzorovanih študijah 3. faze ali v 9-mesečnih odprtih študijah 3. faze.
There were no clinically meaningful differences in the incidence of adverse events following treatment with Xiapex based on the severity of baseline erectile dysfunction or concomitant phosphodiesterase type 5 (PDE5) inhibitor use. 
Klinično pomembnih razlik v incidenci neželenih učinkov po zdravljenju z zdravilom Xiapex na podlagi resnosti erektilne disfunkcije ob izhodišču ali sočasne uporabe zaviralca fosfodiesteraze tipa 5
What Xiapex looks like and contents of the pack 
Izgled zdravila Xiapex in vsebina pakiranja
In the two double-blind, placebo-controlled phase 3 studies in Peyronie's disease, 65.5% of Xiapex-treated patients developed penile haematoma and 14.5% developed penile ecchymosis. 
V dveh dvojno slepih, s placebom nadzorovanih študijah 3. faze za Peyroniejevo bolezen se je pri 65,5 % bolnikov, zdravljenih z zdravilom Xiapex, razvil hematom penisa, pri 14,5 % pa se je razvila ekhimoza penisa.
Total fixed flexion contracture and range of motion following administration of two concurrent injections of Xiapex 0.58 mg in the same hand, mITT population, study AUXCC-867 (first treatment cycle) 
Skupna popravljena fleksijska kontraktura in razpon gibanja po dajanju dveh sočasnih injekcij zdravila Xiapex 0,58 mg v isto roko, populacija mITT, študija AUX-CC-867 (prvi cikel zdravljenja)
Apply a dressing as necessary. 
Po potrebi ga obvežite.
Cumulative Nominal Recurrence by Joint Type (%) 
Skupna nominalna ponovitev glede na vrsto sklepa (%)
• The need to inform the patient about the signs and symptoms associated with the treatment and when to seek attention from the health care provider. 
• opomnik, da je potrebno poročanje o neželenih učinkih, vključno z napakami pri uporabi zdravila, • potreba po informiranju bolnikov o znakih in simptomih, ki so povezani z zdravljenjem, ter o tem, kdaj morajo poiskati pomoč zdravstvenih delavcev, • povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Taking into account the PRAC Assessment Report on the PSUR(s) for collagenase clostridium histolyticum, the scientific conclusions of the CHMP are as follows: 
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za kolagenazo clostridium histolyticum je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
Therefore, use of Xiapex in patients who have received tetracycline antibiotics (e.g., doxycycline) within 14 days prior to receiving an injection of Xiapex is not recommended. 
Uporaba zdravila Xiapex zatorej pri bolnikih, ki so 14 dni pred injekcijo zdravila Xiapex dobivali tetraciklinske antibiotike (npr. doksiciklin), ni priporočljiva.
Erectile dysfunction was reported in 52.9% of patients, and 27.5% reported previous trauma to penis. 
bolnikov, 27,5 % pa jih je poročalo o predhodni poškodbi penisa.
• The active substance is collagenase clostridium histolyticum. 
• Učinkovina je kolagenaza clostridium histolyticum.
The volume of solvent required and the volume of reconstituted Xiapex to be administered into the Dupuytren's cord differs depending on the type of joint being treated (for the reconstitution instructions, see section 6.6, Table 14). 
Volumen potrebnega vehikla in volumen rekonstituiranega zdravila, ki ga bomo dali v Dupuytrenov vozlič, je odvisen od vrste sklepa, ki ga zdravimo (za navodila glede rekonstitucije glejte poglavje 6.6, preglednico 14).
Mean Change from Baseline in Peyronie's Disease Bother Score at Week 36 (LOCF) (mITT* Population) - study AUX-CC-806 
Povprečna sprememba od izhodišča v Seštevku težav zaradi Peyroniejeve bolezni v 36. tednu (LOCF) (populacija mITT*) - študija AUX-CC-806 Xiapex N = 126
A long-term, non-treatment, Year 2 to Year 5 follow-up study (AUX-CC-860) was undertaken to evaluate recurrence of contracture and long-term safety in subjects who received up to 8 single injections of Xiapex 0.58 mg in a previous Phase 3 open-label or double-blind with open-label extension study. 
Izvedli so dolgoročno študijo 2-letnega do 5-letnega spremljanja brez zdravljenja (AUX-CC-860) za ocenitev ponovitev kontrakture in dolgoročne varnosti oseb, ki so prejeli do 8 enkratnih injekcij zdravila Xiapex 0,58 mg v predhodni odprti študiji 3. faze ali dvojno slepi študiji z odprtim podaljšanjem.
This medicine must only be injected into the plaque in your penis by your doctor. 
To zdravilo vam lahko v plak penisa injicira samo zdravnik.
• With one hand, hold the tip of your penis with your fingers. 
• S prsti ene roke držite konico penisa.
Finger extension procedure 
Postopek iztegovanja prstov
Xiapex is a powder and solvent for solution for injection. 
Zdravilo Xiapex je prašek in vehikel za raztopino za injiciranje.
Using a sterile syringe calibrated with 0.01 ml graduations, the appropriate amount of solvent supplied should be withdrawn in order to deliver as follows: 
S sterilno brizgo, ki ima oznake po 0,01 ml, je treba izvleči ustrezno količino priloženega vehikla, da boste dobili naslednje volumne:
Peyronie's disease Penile Fracture (corporal rupture) or other serious injury to the penis 
Peyroniejeva bolezen Zlom penisa (ruptura korpusa) ali druga resna poškodba penisa
• Induce a penile erection 
• Izzovite erekcijo penisa
N=29 N=154 N=123 Mean±SD 6.5±3.47 3.4±3.30 3.2±3.30 2.7±2.84 2.5±3.01 2.4±2.89 Median 6.0 Min, Max 0, 15 
Povprečna vrednost ± SD 6,5 ± 3,47 3,4 ± 3,30 3,2 ± 3,30 2,7 ± 2,84 2,5 ± 3,01 2,4 ± 2,89 Mediana vrednost Min, maks
• thickening near ligament at base of penis 
• odebelitev v bližini ligamentov na korenu penisa
No more than 3 attempts per affected joint are recommended to disrupt a cord. 
Več kot 3 poskusi prekinitve vozliča na prizadeti sklep niso priporočljivi.
Table 3 provides demographic and baseline characteristics for the study population and Tables 4-5 provide the results of the major efficacy endpoints measured in the 2 double-blind placebo-controlled studies CORD I (AUX-CC-857) and CORD II (AUX-CC-859). 
V preglednici 3 so navedene demografske in osnovne značilnosti študijske populacije, preglednici 4-5 pa prikazujeta rezultate glavnih opazovanih dogodkov učinkovitosti, merjenih v dveh dvojno slepih, s placebom nadzorovanih študijah CORD I (AUX-CC-857) in CORD II (AUX-CC-859).
• Using the target plaque as a fulcrum point, use both hands to apply firm, steady pressure to elongate and stretch the plaque. 
• Ciljni plak služi kot vzvodna točka, na katero z obema rokama izvajajte čvrst stalen pritisk in s tem podaljšujete in raztezate plak.
You will be given Xiapex as an injection directly into the area that is causing your finger/penis to bend (intralesional injection). 
Zdravilo Xiapex boste prejeli kot injekcijo neposredno v predel, ki povzroča ukrivljanje prstov/penisa
Do not attempt to disrupt the injected cord by self manipulation at any time. 
Nikoli ne poskušajte pretrgati injiciranega vozliča sami.
-11.4% b a Mean percent change, treatment difference, 95% CI, and p-value were based on an ANOVA model with factors for treatment, stratum of baseline penile curvature, and their interaction and using last observation carried forward (LOCF) in the modified intent-to-treat (mITT) population. 
-11,4 % b a Povprečna sprememba v odstotkih, razlika v zdravljenju, 95-odstotni IZ in vrednost p so temeljili na modelu ANOVA z dejavniki za zdravljenje, stratumom izhodiščne ukrivljenosti penisa in njihovo interakcijo ter z uporabo zadnjega opazovanja, prenesenega naprej (LOCF, last observation carried forward) v prilagojeni populaciji z namenom zdravljenja (mITT, modified intent-to-treat).
h) Upon complete withdrawal of the needle, apply gentle pressure at the injection site. 
h) Po popolnem izvleku igle nežno pritisnite na mesto injiciranja.
Your doctor will inject Xiapex into the plaque that is causing your penis to curve. 
Zdravnik vam bo zdravilo Xiapex injiciral v plak, ki povzroča ukrivljanje penisa.
b) Apply antiseptic at the site of the injection and allow the skin to dry. 
b) Na mesto injiciranja nanesite antiseptik in počakajte, da se koža osuši.
Whilst there is no clinical evidence of an interaction between tetracycline and anthracycline/anthraquinolone antibiotics and anthraquinone derivatives and Xiapex, such derivatives have been shown to inhibit matrix metalloproteinase-mediated collagen degradation at pharmacologically relevant concentrations in vitro. 
antraciklinskih/antrakinolonskih antibiotikov in derivatov antrakinona z zdravilom Xiapex, je bilo ugotovljeno, da ti derivati zavirajo razgradnjo kolagena z matrično metaloproteinazo pri farmakološko relevantnih koncentracijah in vitro.
Mean Baseline (SD) Mean Final (SD) Mean increase (SD) 
povprečno izhodišče (SD) povprečna končna vrednost (SD) povprečno zvečanje (SD)
• Wearing gloves, grasp the plaque or indurated portion of the flaccid penis about 1 cm proximal and distal to the injection site. 
• Oblecite rokavice in plak ali trdi del mlahavega penisa primite približno 1 cm proksimalno in distalno na mesto injiciranja.
These collagenases, referred to as AUX-I and AUX-II, are representative of the two major collagenase classes (Class I and 
Ti dve kolagenazi, ki jih imenujemo AUX-I in AUX-II, sta predstavnici dveh glavnih razredov kolagenaz (razred I in razred II), ki jih izdeluje Clostridium histolyticum.
At the follow-up visit 1 to 3 days after the second injection of each treatment cycle, the trained physician should perform a penile modelling procedure on the flaccid penis to stretch and elongate the treated plaque that Xiapex has disrupted. 
Ob kontrolnem obisku 1 do 3 dni po drugi injekciji vsakega cikla zdravljenja mora usposobljen zdravnik opraviti postopek modeliranja penisa pri mlahavem penisu, da zdravljeni plak, ki ga je zdravilo Xiapex prekinilo, razteza in podaljša.
-1.1 b a Mean change, treatment difference, 95% CI, and p-value all based on an ANOVA model with factors for treatment, stratum of baseline penile curvature, and their interaction and using last observation carried forward (LOCF) in the modified intent-to-treat (mITT) population. 
-1,1 b a Povprečna sprememba, razlika v zdravljenju, 95-odstotni IZ in vrednost p so temeljili na modelu ANOVA z dejavniki za zdravljenje, stratumom izhodiščne ukrivljenosti penisa in njihovo interakcijo ter z uporabo zadnjega opazovanja, prenesenega naprej (LOCF, last observation carried forward) v prilagojeni populaciji z namenom zdravljenja (mITT, modified intent-to-treat).
Special penile conditions/diseases not studied in clinical trials Xiapex treatment in patients having a calcified plaque that could have interfered with the injection technique, chordee in the presence or absence of hypospadias, thrombosis of the dorsal penile artery and/or vein, infiltration by a benign or malignant mass resulting in penile curvature, infiltration by an infectious agent, such as in lymphogranuloma venereum, ventral curvature from any cause and isolated hourglass deformity of the penis has not been studied and treatment in these patients should be avoided. 
Posebna stanja/bolezni penisa, ki jih v kliničnih preskušanjih niso preučili Zdravljenje z zdravilom Xiapex pri bolnikih s kalcificiranim plakom, ki bi lahko vplival na tehniko injiciranja, ukrivljenostjo penisa nazvdol v prisotnosti ali odsotnosti hipospadiaze, trombozo dorzalne arterije in/ali vene penisa, infiltracijo benigne ali maligne tvorbe, ki povzroča ukrivljenost penisa,
At baseline, penile pain was either not present or was mild in most (98%) patients. 
Ob izhodišču pri večini bolnikov (98 %) bolečine v penisu ni bilo ali pa je bila blaga.
• To elevate the injected hand as much as possible until the day after the finger extension procedure. 
• naj držijo zdravljeno roko dvignjeno, kolikor je možno, do dneva po postopku iztegovanja prstov.
After the injection, your doctor will place a dressing on your hand. 
Po injiciranju vam bo zdravnik roko obvezal.
The recommended dose of Xiapex is 0.58 mg per injection administered into a Peyronie's plaque. 
Priporočeni odmerek zdravila Xiapex je 0,58 mg na injekcijo v Peyroniejev plak.
A higher rate for skin laceration has been shown following two concurrent injections in the same hand in a controlled post-marketing trial (see also Section 4.8). 
V nadzorovanem preskušanju po prihodu zdravila na trg se je pokazalo, da so po dveh sočasnih injekcijah v isto roko raztrganine kože pogostejše (glejte tudi poglavje 4.8).
Curvature* 
Ukrivljenost*
The cake of lyophilized powder should be intact and white in colour. 
Pogača liofiliziranega praška mora biti cela in bele barve.
Therefore, the use of Xiapex is not recommended in pregnancy and treatment should be postponed until after pregnancy. 
Zato zdravila Xiapex ne uporabljajte v času nosečnosti in zdravljenje odložite do zaključka nosečnosti.
Prior to each treatment cycle, identify the treatment area as follows: 
Določanje predela zdravljenja Pred začetkom cikla zdravljenja določite predel zdravljenja kot sledi:
In the Dupuytren's contracture clinical trials at 30 days post the first injection, 92% of patients had circulating antibodies detected against AUX-I and 86% of patients against AUX-II. 
V kliničnih preskušanjih Dupuytrenove kontrakture so po 30 dneh po prvem injiciranju pri 92 % bolnikov zaznali cirkulirajoča protitelesa proti AUX-I in pri 86 % bolnikov proti AUX-II.
a Metacarpophalangeal joint; b Proximal interphalangeal joint; c 2 primary joints were excluded from the efficacy analysis (1 joint from the placebo group was not evaluated and 1 joint from the Xiapex treated group had a baseline contracture of 0 degrees before treatment). 
a metakarpofalangealni sklep; b proksimalni interfalangealni sklep; c 2 primarna sklepa sta bila izključena iz analize učinkovitosti (1 sklep iz placebo skupine ni bil ocenjen in 1 sklep iz skupine, zdravljene z zdravilom Xiapex, je imel izhodiščno kontrakturo pred zdravljenjem 0 stopinj).
How Xiapex is used 
Kako se uporablja zdravilo Xiapex
Clinical study experience with Xiapex is currently limited to four treatment cycles in which a total of 8 injections may be administered into the plaque causing the curvature. 
Izkušnje iz kliničnih študij z zdravilom Xiapex so trenutno omejene na štiri cikle zdravljenja, v katerih se lahko v plak, ki povzroča ukrivljenost, aplicira skupno do 8 injekcij.
• upper respiratory infection 
• okužba zgornjih dihal
Powder and solvent for solution for injection 1 vial of powder 
prašek in vehikel za raztopino za injiciranje 1 viala praška
Based on the Patient Global Assessment of Treatment Satisfaction, more than 85% of subjects in the CORD I and CORD II studies reported either being quite satisfied or very satisfied with their treatment with Xiapex versus approximately 30% treated with placebo (p<0.001). 
Na osnovi globalne ocene zadovoljnosti z zdravljenjem je več kot 85 % preskušancev v študijah CORD I in CORD II poročalo, da so bodisi precej zadovoljni bodisi zelo zadovoljni s svojim zdravljenjem z zdravilom
• fast heart rate 
• hiter srčni utrip
Different Fingers, 1 MP, 1 PIP (n=58) 
1 MP, 1 PIP (n = 58)
The symptoms of musculoskeletal syndrome could be joint or muscle pain, shoulder stiffness, hand swelling, fibrosis of the palms, and thickening or nodule forming of tendons. 
Simptomi mišično-skeletnega sindroma so lahko: bolečina v sklepu ali mišicah, togost v rami, otekanje roke, razraščanje veziva v dlani in zadebelitev ali vozliči v kitah.
Most of the side effects that occurred in the clinical studies were mild or moderate in severity and most resolved within 2 weeks of the injection. 
Večina neželenih učinkov, ki so se pojavili v kliničnih študijah, je bila po resnosti blaga ali zmerna in je večinoma izzvenela v 2 tednih od injiciranja.
Tell your doctor if you are thinking about receiving or have previously received Xiapex to treat a condition known as Dupuytren's contracture. 
Zdravniku povejte, če ste že prejemali ali razmišljate o prejemanju zdravila Xiapex za zdravljenje bolezni, imenovane Dupuytrenova kontraktura.
• The solvent contains calcium chloride dihydrate, sodium chloride and water for injections. 
• Vehikel vsebuje kalcijev klorid dihidrat, natrijev klorid in vodo za injekcije.
Most of the side effects that occurred in the clinical studies were mild or moderate in severity and were localised to the hand treated. 
Večina neželenih učinkov, ki so se pojavili v kliničnih študijah, je bilo blagih do zmernih in omejenih na zdravljeno roko.
c) Use only the supplied diluent for reconstitution. 
c) Uporabite samo priložen vehikel za rekonstitucijo.
Adverse reactions reported from the clinical programme are those that occurred in the Phase 3 double blind placebo-controlled studies for the treatment of Dupuytren's contracture in adult patients with a palpable cord (AUX-CC-857, AUX-CC-859) and the post-marketing clinical studies (AUX-CC-864, AUX-CC-867) for two concurrent injections in the same hand. 
Neželeni učinki, o katerih so poročali v kliničnem programu, so tisti, ki so se pojavili v fazi 3 dvojno slepih, s placebom nadzorovanih študij za zdravljenje Dupuytrenove kontrakture pri odraslih bolnikih z otipljivim vozličem (AUX-CC-857, AUX-CC-859) in v kliničnih študijah AUX-CC-864, AUX-CC-867) iz obdobja trženja za dve sočasni injekciji v isto roko.
Low levels of Xiapex were quantifiable in the plasma of evaluable male patients for up to 30 minutes following administration of Xiapex into the penile plaque of patients with Peyronie's disease (see section 5.2). 
V plazmi moških bolnikov, ki so bili primerni za ocenitev, so bile v 30 minutah po injiciranju zdravila Xiapex v plak penisa pri bolnikih s Peyroniejevo boleznijo merljive nizke ravni zdravila Xiapex (glejte poglavje 5.2).
The reconstituted solution of Xiapex must be clear. 
Rekonstituirana raztopina zdravila Xiapex mora biti bistra.
Mean Change in Peyronie's Disease Bother Domain Score from Baseline to Week 52 - Studies 1 and 2 
Povprečna sprememba rezultata Področja težav Peyroniejeve bolezni od izhodišča do 52. tedna - študiji 1 in 2 Študija 1
At five years after the initial injection of Xiapex, 92.8% and 93.4% of subjects were seropositive for anti-AUX-I and anti-AUX-II respectively. 
Po petih letih po začetni injekciji zdravila Xiapex je bilo 92,8 % oseb seropozitivnih za anti-AUX-I in 93,4 % oseb je bilo seropozitivnih za anti-AUX-II.
• feeling of pain in the groin, shoulder, chest wall, or neck 
• občutek bolečine v dimljah, rami, prsnem košu ali vratu;
• bruising or swelling of the penis and pain in the penis 
• modrica ali oteklina penisa in bolečina v penisu
The rubber stopper and surrounding surface of the vial containing Xiapex and the vial containing the solvent for reconstitution should be swabbed with sterile alcohol (no other antiseptics must be used). 
Gumijasti zamašek in površino okoli viale, ki vsebuje zdravilo Xiapex, in na viali, ki vsebuje vehikel za rekonstitucijo, je treba očistiti s sterilnim alkoholom (drugih razkužil se ne sme uporabiti).
The following information is intended for healthcare professionals only: Instructions for use and handling 
Naslednje informacije so namenjene samo zdravstvenemu osebju: Navodila za uporabo in rokovanje z zdravilom Peyroniejeva bolezen
The incidence of skin laceration (29.1%) was higher for subjects treated with two concurrent injections of Xiapex in historically-controlled clinical study AUX-CC-867 compared with subjects treated with up to three single injections in the Phase 3 placebo-controlled pivotal studies in Dupuytren's contracture (CORD I and CORD II) (8.8%). 
Incidenca raztrganja kože (29,1 %) je bila v klinični študiji AUX-CC-867, nadzorovani z obstoječimi podatki, večja za osebe, zdravljene z dvema sočasnima injekcijama zdravila Xiapex, v primerjavi z osebami, zdravljenimi z do tremi enkratnimi injekcijami v ključnih študijah 3. faze za Dupuytrenovo kontrakturo, nadzorovanih s placebom (CORD I in CORD II) (8,8 %).
Only stretch your penis if your penis is not hard (erect). 
Penis nežno raztezajte 3-krat na dan. Penis si raztezajte le, če ni trd (v erekciji).
The patient should then be instructed to self-perform penile modelling activities at home each day for the 6-week period following the physician penile plaque modelling visit of each treatment cycle, according to the detailed instructions provided in the package leaflet. 
Bolniku je treba dati navodila za samoizvajanje aktivnosti modeliranja penisa doma, vsak dan za obdobje 6 tednov po obisku vsakega cikla zdravljenja, na katerem zdravnik opravi modeliranje plaka penisa, v skladu s podrobnimi navodili v navodilu za uporabo.
In the double-blind portion of the three phase 3 placebo-controlled clinical studies in Dupuytren's contracture, 17% of Xiapex-treated patients had mild reactions (i.e. pruritus) after up to 3 injections. 
V dvojno slepem delu treh kliničnih študij 3. faze za Dupuytrenovo kontrakturo, ki so bile nadzorovane s placebom, je imelo 17 % bolnikov, zdravljenih z zdravilom Xiapex, blage reakcije (npr. pruritus) po do 3 injekcijah.
• the percent change from baseline to Week 52 in penile curvature deformity and 
• sprememba deformacije ukrivljenosti penisa v odstotkih od izhodišča do 52. tedna in
In the three double-blind, placebo-controlled phase 3 studies in Dupuytren's contracture, 73% of Xiapex-treated patients reported an ecchymosis or a contusion and 38% reported a haemorrhage at the injection site. 
V treh dvojno slepih, s placebom nadzorovanih študijah 3. faze za Dupuytrenovo kontrakturo je 73 % bolnikov, ki so bili zdravljeni z zdravilom Xiapex, poročalo o pojavu ekhimoze ali kontuzije in 38 % o pojavu krvavitve na mestu injiciranja.
The section 4.8 of the SmPC is updated to include the adverse reactions “digital necrosis” and “digital fracture” with a frequency “not known”. 
povzetka glavnih značilnosti zdravila se posodobi tako, da se vključijo neželeni učinki “nekroza prsta” in “zlom prsta” s pogostnostjo “neznana”.
If the solution contains particles, is cloudy or discoloured, it should not be injected. 
Če raztopina vsebuje delce, je motna oziroma obarvana, je ne smete uporabiti.