natgillin/translations-raw huggingface dataset:
sudden loss of the ability to maintain an erection, pain in your penis, purple bruising and swelling of your penis, difficulty urinating or blood in the urine, a collection of blood under the skin at the injection site. 
Takoj pokličite zdravnika, če se pojavijo simptomi zloma penisa ali druge resne poškodbe penisa, ki so naslednje: pokajoč zvok ali občutek v penisu med erekcijo, nenadna izguba zmožnosti ohranjanja erekcije, bolečina v penisu, vijolična modrica in oteklina penisa, težave z uriniranjem ali kri v urinu, kopičenje krvi pod kožo na mestu injiciranja.
Caution should be exercised when performing finger extension procedures in patients with bone fragility, which may predispose to digital phalangeal fracture (e.g. in patients with osteopenia/osteoporosis). 
Pri bolnikih s krhkimi kostmi, ki bi lahko bili nagnjeni k falangealnim zlomom (npr. pri bolnikih z osteopenijo/osteoporozo), je pri izvajanju postopkov iztegovanja prstov potrebna previdnost.
Cases of skin laceration requiring skin graft after finger extension procedures have been reported postmarketing. 
V obdobju trženja zdravila so po postopkih iztegovanja prstov poročali o primerih raztrganin kože,
There has been no evidence of systemic toxicity to date in the clinical studies conducted with Xiapex administered through localized injection into the Dupuytren's cord or into the Peyronie's plaque. 
Do danes v kliničnih študijah, ki so jih naredili z aplikacijo zdravila Xiapex z lokalno injekcijo v Dupuytrenov vozlič ali v Peyroniejev plak, ni bilo dokazov sistemske toksičnosti.
• Not to attempt to disrupt the injected cord by self-manipulation at any time. 
• naj nikoli sami ne poskušajo pretrgati injiciranega vozliča;
Xiapex powder is supplied in a clear glass vial (3 ml, type I glass) with rubber stopper, aluminium seal and flip-off cap (polypropylene). 
Prašek Xiapex v viali iz prosojnega stekla (3 ml, steklo tip I) z gumijastim zamaškom, aluminijastim obročkom in dvižno zaporko (polipropilen)
Use only the supplied diluent for reconstitution. 
Uporabite samo priložen vehikel za rekonstitucijo.
If refrigerated, the reconstituted solution must be allowed to return to ambient room temperature (20ºC-25ºC) for approximately 15 minutes before use. 
Če jo shranjujete v hladilniku, je treba rekonstituirano raztopino približno 15 minut pred uporabo pustiti, da se segreje na sobno temperaturo (20 ºC-25 ºC).
Contents of the pack and other information 
Shranjevanje zdravila Xiapex Vsebina pakiranja in dodatne informacije
When Xiapex was given intravenously every other day to male and female rats before cohabitation and through mating and implantation, no effects on the oestrus cycle, tubal transport, implantation and pre-implantation development and/or on libido or epididymal sperm maturation were noted with intravenous doses up to 0.13 mg/dose (approximately 11 times the human dose on a mg/m2 basis). 
vgnezditev in pred-vgnezditveni razvoj in/ali libido ali epididimsko zorenje semena pri intravenskih odmerkih do 0,13 mg/odmerek (približno 11-krat človeški odmerek na osnovi izračuna mg/m2).
You should gently straighten your penis 1 time a day for 6 weeks after each treatment cycle. 
Penis si 6 tednov po vsakem ciklu zdravljenja nežno ravnajte 1-krat na dan.
Clinical study experience with Xiapex is currently limited to up to 3 injections per cord and up to 8 injections in total. 
Trenutno pridobljene izkušnje iz kliničnih študij z zdravilom Xiapex se nanašajo na do 3 injekcije na posamezni vozlič in na 8 injekcij skupaj.
Before use, remove the vial containing the lyophilized powder of Xiapex and the vial containing the diluent for reconstitution from the refrigerator and allow the two vials to stand at room temperature for at least 15 minutes and no longer than 60 minutes. 
Pred uporabo vialo, ki vsebuje liofiliziran prašek zdravila Xiapex, in vialo, ki vsebuje vehikel za rekonstitucijo, vzemite iz hladilnika in obe viali pustite na sobni temperaturi vsaj 15 minut in ne dlje kot 60 minut.
The vial containing Xiapex and the vial containing the solvent for solution for injection for reconstitution must be refrigerated. 
Viala, ki vsebuje zdravilo Xiapex, in viala, ki vsebuje vehikel za raztopino za injiciranje za rekonstitucijo morata biti shranjeni v hladilniku.
Only straighten your penis if you have an erection that happens without any sexual activity (spontaneous erection). 
Navodila za nežno ravnanje penisa Penis nežno ravnajte enkrat na dan. Penis si nežno ravnajte le, ko imate erekcijo, do katere pride brez spolne aktivnosti (spontana erekcija).
d) Using a new hubless syringe containing 0.01 ml graduations with a permanently fixed 27-gauge 
d) Z uporabo nove sterilne brizge brez spojnega dela, z oznakami po 0,01 ml in trajno pričvrščene
No new safety signals were identified among subjects who were retreated with Xiapex. 
Pri osebah, ki so bile ponovno zdravljenje z zdravilom Xiapex, niso ugotovili novih signalov glede varnosti.
• the change from baseline to Week 52 in the Bother domain of the Peyronie's Disease 
• sprememba od izhodišča do 52. tedna v rezultatu Področja težav (Bother domain) Vprašalnika o
Table 2: Tabulated list of adverse reactions. 
Preglednica 2: Seznam neželenih učinkov v preglednici
You should gently stretch your penis 3 times a day for 6 weeks after each treatment cycle. 
Penis si 6 tednov po vsakem ciklu zdravljenja nežno raztezajte 3-krat na dan.
• rupture of a tendon, ligament injury 
• pretrganje kite, poškodba ligamenta (vezivno tkivo med kostmi);
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
PRILOGA II A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE IN IZDELOVALEC (IZDELOVALCI),
Clinical success (a reduction of contracture to ≤5° within 30 days) after two concurrent injections of Xiapex (one per joint) in the same hand was achieved for the majority of MP joints (64.6%) compared with 28.6% of PIP joints following a single injection per affected joint. 
Xiapex (ena na sklep) v isto roko so dosegli za večino MP sklepov (64,6 %), v primerjavi z 28,6 %
The overall safety profile was similar regardless of the timing of the post-injection finger extension procedure (i.e., 24 hours, 48 hours, and ≥72 hours after injection) among patients who received two concurrent injections of Xiapex in Study AUX-CC-867. 
24 ur, 48 ur in ≥ 72 ur po injiciranju), med bolniki, ki so prejeli dve sočasni injekciji zdravila Xiapex v študiji AUX-CC-867.
Hydrochloric acid 2.4% w/w (for pH adjustment) 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi prašek saharoza trometamol klorovodikova kislina 2,4 % w/w (za uravnavanje pH)
Reconstituted Xiapex can be kept at ambient room temperature (20ºC-25ºC) for up to one hour or refrigerated at 2ºC-8˚C for up to 4 hours prior to administration. 
Rekonstituirano zdravilo Xiapex lahko shranjujete pri sobni temperaturi (20 ºC-25 ºC) največ eno uro ali v hladilniku pri 2 ºC-8 ˚C največ 4 ure pred aplikacijo.
Because Xiapex lyses collagen, care must be taken to avoid injecting into tendons, nerves, blood vessels, or other collagen-containing structures of the hand. 
je treba paziti, da ga ne injiciramo v kite, živce, krvne žile ali druge strukture roke, ki vsebujejo kolagen.
The incidence of Xiapex-associated pruritus increased after more Xiapex injections in patients with Dupuytren's contracture. 
Dupuytrenovo kontrakturo po več injekcijah zdravila Xiapex povečala.
Yes No Physician Rating of Severity at Baseline Mild Moderate Severe Missing1 Note: Includes all patients who received at least 1 injection of double-blind study medicinal product (Xiapex 0.58 mg or placebo). 
Opomba: vključuje vse bolnike, ki so prejeli vsaj eno injekcijo dvojno slepega zdravila v kliničnem preskušanju (Xiapex 0,58 mg ali placebo).
Baseline, mean (SD) Day 31, mean (SD) Change, mean (SD) FFC = Fixed flexion contracture ROM = Range of motion 
PFK = popravljena fleksijska kontraktura RG = razpon gibanja
a Baseline was defined as the last observation prior to the first injection of Xiapex in the previous phase 3 study (i.e AUX-CC-802, AUX-CC-803, AUX-CC-804 or AUX-CC-806) b Reference was defined as the last post-baseline non-missing observed value from the previous phase 3 study (i.e AUX-CC-802, AUX-CC-803, AUX-CC-804 or AUX-CC-806) * Note: 29 subjects were excluded from this analysis. 
b Referenčna vrednost je bila opredeljena kot zadnja znana opazovana vrednost po izhodišču iz prejšnje študije 3. faze (tj. AUX-CC-802, AUX-CC-803, AUX-CC-804 ali AUX-CC-806).
Table 1: Tabulated list of adverse reactions. 
Preglednica 1: Seznam neželenih učinkov v preglednici
N=183 N=183 N=34 
N = 183 N = 183 N = 34 N = 29 N = 154 N = 123
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 Peyronie's disease (see section 4.2 for information on paediatric use). 
Xiapex za zdravljenje Peyroniejeve bolezni za vse podskupine pediatrične populacije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
This indicates the target area in the plaque for Xiapex deposition 
To je ciljno območje v plaku za vnos zdravila
d Includes: contusion, ecchymosis, penile haemorrhage, and injection site haemorrhage. 
d Vključuje: kontuzijo, ekhimoze, krvavitev penisa in krvavitev na mestu injiciranja.
Discard the syringe and needle used for reconstitution and the diluent vial. 
Brizgo in iglo, ki ste ju uporabili za rekonstitucijo, in vialo z vehiklom zavrzite.
Cumulative Nominal Recurrence Rate (%)c 
Delež skupne nominalne ponovitve c
• formation of a blood clot inside the penile vein 
• nastajanje krvnih strdkov znotraj vene penisa
• Locate the plaque at the point of maximum concavity (or focal point) in the bend of the penis 
• Določite plak na točki največje vbokline (fokalni točki) v prelomu penisa • Točko označite s kirurškim markerjem.
Almost all patients had positive titers for anti-AUX-I antibodies (97.9%) and anti-AUX-II antibodies (97.5%) 60 days post two concurrent injections. 
AUX-I (97,9 %) in protitelesa proti AUX-II (97,5 %).
Xiapex 0.58 mg dose† 
Volumen injekcije za aplikacijo odmerka zdravila Xiapex 0,58 mg†
Treatment area 
Operacija po zdravljenju
Hold pressure for 30 seconds then release. 
Pritisk na penis je treba vzdrževati 30 sekund.
Other endpoints included ≥50% reduction from baseline in degree of contracture, percent change from baseline in degree of contracture, change from baseline in range of motion, subject global assessment of treatment satisfaction and physician global assessment of severity. 
spremembo razpona gibanja glede na izhodišče, globalno oceno zadovoljnosti z zdravljenjem preskušanca in zdravnikovo globalno oceno resnosti.
• pain at the injection site and above the penis 
• bolečina na mestu injiciranja in nad penisom • mehur ali rdečina/obarvanje penisa
• For cords affecting PIP joints, each dose is administered in an injection volume of 0.20 ml. 
• Za vozliče, ki prizadenejo PIP sklepe, za vsak odmerek uporabite volumen za injiciranje
Using a 1 ml syringe with 0.01 ml graduations with a 27-gauge 12-13 mm needle (not supplied), withdraw the correct volume of the diluent supplied: 
Uporabite 1 ml brizgo, ki ima oznake po 0,01 ml, in 12-13 mm iglo velikosti G 27 (ni priložena) ter izvlecite pravilni volumen priloženega vehikla:
In the double-blind portion of the two phase 3 placebo-controlled clinical trials in Peyronie's disease, a greater proportion of Xiapex-treated patients (4%) compared to placebo-treated patients (1%) had localized pruritus after up to 4 treatment cycles (involving up to 8 Xiapex injections). 
V dvojno slepem delu dveh kliničnih preskušanj 3. faze za Peyroniejevo bolezen, ki sta bila nadzorovana s placebom, je imel po do 4 ciklih zdravljenja (vključno z do 8 injekcijami zdravila
N=203 c 
n = 202
• dizziness, headache, nausea 
• omotica, glavobol, navzea;
Skin disorder, nodule, granuloma, blister, irritation or oedema 
napetost kože, odrevenelost, draženje ali vozliči, krasta, rana;
An anaphylactic reaction was reported in a post-marketing clinical study in a patient who had previous exposure to Xiapex for the treatment of Dupuytren's contracture, demonstrating that severe reactions including anaphylaxis can occur following Xiapex injections. 
Iz klinične študije v obdobju trženja zdravila so poročali o anafilaktični reakciji pri bolniku, ki je bil predhodno izpostavljen zdravilu Xiapex zaradi zdravljenja Dupuytrenove kontrakture, kar kaže na to,
Administration of a local anaesthetic medicinal product prior to injection of Xiapex into a Dupuytren's cord is not recommended, as it may interfere with proper placement of the injection. 
Dajanje lokalnih anestetikov pred injiciranjem zdravila Xiapex v Dupuytrenov vozlič se ne priporoča,
Each vial of powder contains 0.9 mg of collagenase clostridium histolyticum*. 
Ena viala praška vsebuje 0,9 mg kolagenaze clostridium histolyticum*.
Sodium injected per joint in the treatment of Dupuytren's contracture: Metacarpophalangeal (MP) joints: 0.9 mg. 
natrij, injiciran na sklep pri zdravljenju Dupuytrenove kontrakture: metakarpofalangealni (MP) sklepi: 0,9 mg proksimalni interfalangealni (PIP) sklepi: 0,7 mg natrij, injiciran na plak pri zdravljenju Peyroniejeve bolezni: 0,9 mg Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Mean duration of PD (years) (Min-Max) 
Povprečno trajanje PB (leta)
• a small collection of blood under the skin at the injection site 
• majhno število krvnih ploščic v krvi;
3 ml solution is supplied in a 5 ml type I clear glass vial with rubber stopper, aluminium seal and flip-off plastic cap. 
3 ml raztopine je na voljo v 5 ml viali iz prosojnega stekla tipa I z gumijastim zamaškom, aluminijastim obročkom in plastično polipropilensko dvižno zaporko.
System organ class Very common Common Uncommon 
Organski sistem zelo pogosti pogosti
Xiapex 0.9 mg powder and solvent for solution for injection collagenase clostridium histolyticum 
Xiapex 0,9 mg prašek in vehikel za raztopino za injiciranje kolagenaza clostridium histolyticum
• scrotal redness, swelling and pain 
• rdečina, oteklina in bolečina skrotuma
Discard the unused portion of the reconstituted solution and solvent after injection. 
Po injiciranju zavrzite neporabljeno rekonstituirano raztopino in vehikel.
The powder is a white lyophilised powder. 
prašek in vehikel za raztopino za injiciranje Prašek je bel, liofiliziran prašek.
The solution should slowly be swirled to ensure that all of the lyophilised powder has gone into solution. 
Raztopino morate sukati počasi s krožnimi gibi, da se bo ves liofiliziran prašek raztopil v raztopini.
Mean Percent Change from Baseline in Curvature Deformity at Week 36 (LOCF) (mITT* Population) - study AUX-CC-806 
36. tednu (LOCF) (populacija mITT*) - študija AUX-CC-806 Xiapex N = 126
Solvent for Xiapex 
Zdravilo XIAPEX
The following side effects have been seen with Xiapex administered in up to two cords or joints per treatment visit: 
Pri zdravilu Xiapex, danem v do dva vozliča ali sklepa na obisk za zdravljenje, so opažali naslednje neželene učinke:
Dupuytren's MP joints 
Dupuytrenovi MP sklepi
Digital necrosisd Digital fractured a reported with a higher incidence (very common) in patients who received two concurrent injections of Xiapex in the same hand compared with subjects treated with up to three single injections in the Phase 3 placebo-controlled pivotal studies in Dupuytren's contracture. 
Xiapex,v isto roko v primerjavi z osebami, zdravljenimi z do tremi enkratnimi injekcijami v ključnih študijah 3. faze za Dupuytrenovo kontrakturo, nadzorovanih s placebom.
12 or 13 mm needle (not supplied), withdraw a volume of 0.25 ml of reconstituted solution 
12 ali 13-milimetrske igle velikosti G 27 (ni priložena) izvlecite volumen 0,25 ml rekonstituirane raztopine (ki vsebuje 0,58 mg zdravila Xiapex).
Injections in up to two cords or two affected joints in the same hand can be administered during a treatment visit. 
Med obiskom za zdravljenje se lahko injicira zdravilo v do dva vozliča ali dva prizadeta sklepa iste roke.
• burning sensation, partial loss of sensitivity, feeling of “pins and needles” or numbness 
• oteklina in bolečina sklepov; • pekoč občutek, delna izguba občutkov, mravljinčenje ali odrevenelost;
• reactions at the site of injection including peeling of the skin, skin discolouration, infection, pain, skin tightness, numbness, irritation or nodules, scab, wound 
• reakcije na mestu injiciranja, vključno z luščenjem kože, obarvanje kože, okužba, bolečina,
• shortness of breath, hyperventilation 
• kratka sapa, pospešeno dihanje;
Suprapubic pain 
Dupuytrenovi PP sklepi
A. 
AUX-II.
• tenderness in ligament at base of penis 
• občutljivost ligamenta na korenu penisa
• tenderness 
• omotičnost
Peyronie's Disease Questionnaire (PDQ)b,Mean Patient-Reported PD Bother Domain Score (range: 0-16) c 
(PDQ)b, - povprečni rezultat Področja težav, kot jih poročajo bolniki (razpon:
Powder: Contains sucrose, trometamol, hydrochloric acid Solvent: Contains calcium chloride dihydrate, sodium chloride, water for injection 
Vehikel: vsebuje kalcijev klorid dihidrat, natrijev klorid, vodo za injekcije.
A single-use syringe containing 0.01-ml graduations with a permanently fixed 27-gauge 12 or 13 mm needle (not supplied) should be used to withdraw the volume of reconstituted solution. 
Za izvlek volumna rekonstituirane raztopine je treba uporabiti brizgo za enkratno uporabo z oznakami po 0,01 ml s fiksno pritrjeno 12- ali 13-mm iglo velikosti G 27 (ni priložena).
Sexual dysfunction Scrotal erythema Genital discomfort Genital haemorrhage Pelvic pain 
presnovne in prehranske motnje zastajanje tekočine psihiatrične motnje nenormalne sanje depresija zavrta spolnost bolezni živčevja glavobol omotica disgevzija parestezija pekoč občutek hiperestezija hipoestezija
Penile blister Pruritus genital Painful erection Erectile dysfunction Dyspareunia Penile erythema 
oteklinab, bolečinac ali ekhimozad mehur na penisu genitalni pruritus boleča erekcija erektilna disfunkcija disparevnija eritem penisa adhezija penisa bolezen penisa napredovanje Peyroniejeve bolezni spolna disfunkcija eritem skrotuma genitalno nelagodje genitalna krvavitev bolečina v medenici zmanjšanje velikosti penisa tromboza vene penisa edem skortuma bolečina skrotuma
• penis disorder 
• bolezen penisa
• constipation 
• občutljivost
30 seconds. 
0 stopinj).
• skin cut 
• raztrganina na koži
Musculoskeletal discomfort or stiffness, joint stiffness or crepitation Limb discomfort Tendonitis Muscle spasms or weakness 
obarvanje ali krasta bolezni mišično skeletnega sistema in vezivnega tkiva bolečina v udu artralgija tvorba pod pazduho oteklina sklepa mialgija bolečina v prsnem košu, dimljah, vratu ali rami nelagodje ali togost mišično-skeletnega sistema, togost ali krepitacije sklepa nelagodje uda tendonitis mišični spazmi ali šibkost mišic motnje reprodukcije in dojk občutljivost dojk hipertrofija dojk
Questionnaire (PDQ) 
povprečje (SD)
A popping noise or popping sensation in the penis, sometimes described as “snapping” or “cracking” and sometimes accompanied by detumescence, haematoma and/or pain, were reported in 73/551 (13.2%) Xiapex-treated patients and 1/281 (0.3%) placebo-treated patients, in Studies 1 and 2 combined. 
zdravljenih s placebom, se je v študiji 1 in 2 skupaj pojavil pokajoč zvok ali pokajoč občutek v penisu, včasih opisan kot "tleskanje" ali "pokanje", ki so ga včasih spremljali detumescenca, hematom in/ali bolečina.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent vial for use with Xiapex label 
OVOJNINAH nalepka na viali vehikla za uporabo z zdravilom Xiapex
Each powder vial contains 0.9 mg collagenase clostridium histolyticum 
Ena viala s praškom vsebuje 0,9 mg kolagenaze clostridium histolyticum.
In the two Phase 3 double-blind placebo-controlled studies, most adverse reactions were local events of the penis and groin and the majority of these events were of mild or moderate severity, and most (79%) resolved within 14 days of the injection. 
Večina teh posledic je bila blagih ali zmernih in največ (79 %) jih je izzvenelo v 14 dneh po injiciranju.
After needle placement, if there is any concern that the needle is in the flexor tendon, apply a small amount of passive motion at the distal interphalangeal (DIP) joint. 
Po namestitvi igle izvedite majhen pasiven gib distalnega interfalagealnega sklepa (DIP), da se prepričate, da igla ni v kiti upogibalki.
• pain in your penis 
• bolečina v prsnem košu
Solvent: 3 ml solution supplied in a clear glass vial (5 ml, type I glass) with rubber stopper, aluminium seal and flip-off cap (polypropylene). 
Vehikel: 3 ml raztopine v viali iz prosojnega stekla (5 ml, steklo tip I) z gumijastim zamaškom,
Next, keeping the needle under the skin at all times, withdraw the needle tip from the cord and reposition it in a slightly more distal location (approximately 2-3 mm) to the initial injection in the cord and inject another one-third of the dose. 
Nato izvlecite konico igle iz vozliča in jo namestite nekoliko bolj distalno v vozlič (približno 2
How to store Xiapex 
Shranjevanje zdravila Xiapex
Xiapex treatment significantly improved penile curvature deformity in patients with Peyronie's disease compared with placebo (Table 9). 
Peyroniejevo boleznijo v primerjavi s placebom (preglednica 9).
• hives 
• modrice
Caution should be exercised when Xiapex is administered to a breast-feeding woman. 
Xiapex doječim ženskam je potrebna previdnost.
Slowly swirl the solution to ensure that all of the lyophilized powder has gone into solution. 
Počasi s krožnimi gibi sukajte raztopino, da se bo ves liofiliziran prašek raztopil.
• groin pain and discomfort 
• bolečina v bezgavki in otekle bezgavke
• sore on the skin of the penis 
• razjede na koži penisa
Symptoms of penile fracture (corporal rupture) or other serious injury to your penis may include: 
Simptomi zloma penisa (rupture korpusa) ali drugih resnih poškodb penisa lahko vključujejo: • pokajoč zvok ali občutek v penisu med erekcijo
Baselinea 
• koprivnica
• increased perspiration 
• povečano znojenje.
• discomfort, injury, paralysis of the limb 
• kronična bolečina; • nelagodje, poškodba ali ohromelost okončine;
The white lyophilized powder is supplied in a 3 ml type I clear glass vial with rubber stopper, aluminium seal and flip-off plastic cap. 
3 ml viali iz prosojnega stekla tipa I z gumijastim zamaškom, aluminijastim obročkom in plastično dvižno zaporko.
• swollen or enlarged glands near the elbow or under the arm 
• občutek bolečine v roki, zapestju ali celi zgornji okončini; • otečene ali povečane bezgavke blizu komolca ali pod pazduho;
- If you get any side effects, talk to your doctor. 
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
Inspect the solution visually for particulate matter and discolouration prior to administration. 
Pred uporabo raztopino preglejte s prostim očesom, ali vsebuje delce in ali je obarvana.
Visually inspect the vial containing Xiapex. 
Vialo, ki vsebuje zdravilo Xiapex, preglejte s prostim očesom.
The solution should visually be inspected for particulate matter and discoloration prior to administration. 
Raztopino morate pred aplikacijo pregledati s prostim očesom, da se prepričate, da ne vsebuje delcev in da ni obarvana.
• skin disorder/irritation 
• kožna bolezen/draženje kože
Use caution with cords as they approach the PIP flexion crease area. 
Pri vozličih, ki se nahajajo blizu predela PIP fleksijske gube, bodite previdni.
Penile size reduced Penile vein thrombosis Scrotal oedema Scrotal pain 
OVOJNINAH nalepka na viali praška Xiapex
• vomiting, diarrhoea, upper abdominal pain 
• bruhanje, driska, bolečina v zgornjem delu trebuha; • izpuščaj, ekcem;
XIAPEX N=199 
n = 199
Skin lacerationa,b 
Bel liofoliziran prašek je na voljo v
• injection site rash 
• izpuščaj na mestu injiciranja
f) The reconstituted Xiapex solution can be kept at room temperature (20º to 25ºC) for up to one hour or refrigerated at 2º to 8°C for up to 4 hours prior to administration. 
f) Rekonstituirano raztopino zdravila Xiapex lahko hranite pri sobni temperaturi (20 º do 25 ºC)
STATEMENT OF ACTIVE SUBSTANCE(S) 
Sprememba od izhodišča povprečje (SD)
Procedural pain Fracture of penis Skin laceration 
• bolečino v penisu • vijolično modrico in oteklino penisa