natgillin/translations-raw huggingface dataset:
• fever, general pain, discomfort, tiredness, feeling hot, malaise, flu-like illness 
• vrućica, generalizirani bol, nelagoda, umor, osjećaj vrućine, slabost, bolest nalik gripi • nepodnošenje hladnoće u liječenim prstima
Confirm the joint to be treated (metacarpophalangeal [MP] or proximal interphalangeal [PIP]) as the volume of solvent required for reconstitution is determined by the type of joint (PIP joint requires a smaller volume for injection). 
Odredite koji će se zglob liječiti (metakarpofalangealni [MP] ili proksimalni interfalangealni [PIP]) jer vrsta zgloba određuje volumen otapala potrebnog za rekonstituciju (za PIP zglob potreban je manji volumen za injekciju).
Following Xiapex injection, severe allergic reaction could occur, and patients should be observed for 30 minutes before leaving the clinic in order to monitor for any signs or symptoms of a serious allergic reaction, e.g. wide spread redness or rash, swelling, tightness in the throat or difficulty breathing. 
30 minuta prije napuštanja ambulante kako bi se uočili bilo kakvi znakovi ili simptomi ozbiljne alergijske reakcije, npr. prošireno crvenilo ili osip, oticanje, stezanje u grlu ili otežano disanje.
Cases of skin laceration requiring skin graft after finger extension procedures have been reported postmarketing. 
Nakon stavljanja lijeka u promet zabilježeni su slučajevi laceracije kože koji su zahtijevali presađivanje kože nakon postupaka ekstenzije prsta.
Curvature* 
Zakrivljenost*
PDQ bother** 
Tegobe prema PDQ-u**
This includes medicines to help control the normal clotting of your blood (known as anticoagulation medicines), anthraquinone derivatives, some antibiotics (tetracyclines and anthracyclines/anthraquinolones) used to treat infections. 
derivate antrakinona, neke antibiotike (tetracikline i antracikline/antrakinolone) za liječenje infekcija.
Clinical study experience with Xiapex is currently limited to up to 3 injections per cord and up to 8 injections in total. 
Iskustvo iz kliničkih ispitivanja Xiapexa trenutno je ograničeno na najviše 3 injekcije po tračku i do 8
Baseline, mean (SD) Day 31, mean (SD) Change, mean (SD) FFC = Fixed flexion contracture ROM = Range of motion 
FFC = fiksna fleksijska kontraktura ROM = raspon pokreta
• superficial vein inflammation 
• upala površinskih vena
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) 
Tablica 6. Cjelokupna fiksna fleksijska kontraktura i raspon pokreta nakon istovremene primjene dvije injekcije Xiapexa u dozi od 0,58 mg u istu šaku, populacija mITT, ispitivanje AUX
Contact your doctor right away if you are concerned by increasing pain or symptoms in the fingers after the treatment. 
Ako ste nakon terapijskog postupka zabrinuti zbog jačanja bolova ili nekih drugih simptoma povezanih s prstima, odmah se obratite liječniku.
The vial containing Xiapex and the vial containing the solvent for solution for injection for reconstitution must be refrigerated. 
Bočica koja sadrži Xiapex i bočica koja sadrži otapalo za rekonstituciju otopine za injekciju moraju biti u hladnjaku.
Reconfirm the cord to be injected. 
Ponovno utvrdite u koji tračak ćete dati injekciju.
• rupture of a tendon, ligament injury 
• puknuće tetive, ozljeda ligamenta
Tendon rupture or other serious injury to the injected finger/hand in the treatment of Dupuytren's contracture 
Ruptura tetive ili druge ozbiljne ozljede injiciranog prsta/šake u liječenju Dupuytrenove kontrakture Xiapex se smije injicirati samo u Dupuytrenov tračak.
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. 
Dupuytrenovom kontrakturom, 17% bolesnika liječenih Xiapexom imalo je blage reakcije (tj. svrbež) nakon najviše 3 injekcije.
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). 
implantaciju i predimplantacijski razvoj i/ili libido ili sazrijevanje sperme u pasjemeniku kod intravenskih doza do 0,13 mg/dozi (približno 11 puta veće od ljudske doze na temelju mg/m2).
b “skin laceration” includes “injection site laceration” and “laceration” c “oedema peripheral” includes “injection site oedema” and “oedema” d see also section 4.4 
b „Laceracija kože“ uključuje „laceraciju na mjestu injekcije“ i „laceraciju“.
Haematoma Hypotension 
Krvožilni poremećaji hematomi hipotenzija
Gently stretch your penis 3 times a day. 
Nježno ispravljajte svoj penis jedanput na dan.
Headache Dizziness Dysgeusia Paraesthesia Burning sensation Hyperaesthesia Hypoaesthesia 
Poremećaji živčanog sustava glavobolja omaglica disgeuzija parestezija osjećaj žarenja hiperestezija hipoestezija
• scar tissue in penis 
• ožiljak na penisu
• burning sensation, partial loss of sensitivity, feeling of “pins and needles” or numbness 
• žarenje, djelomičan gubitak osjetljivosti, trnci i žmarci ili utrnulost
Penile fracture (corporal rupture) or other serious injury to the penis 
Prijelom penisa (ruptura korpusa) ili druge ozbiljne ozljede penisa
The solution should slowly be swirled to ensure that all of the lyophilised powder has gone into solution. 
Otopinu treba polako promiješati kružnim pokretima kako biste bili sigurni da je sav liofilizirani prašak prešao u otopinu.
• blood pressure increased 
• povišen krvni tlak • zadržavanje vode
An improvement from baseline was also seen in range of motion at Day 31 for all the treated joint pair subgroups, see Table 6. 
31. dana bilo je opaženo i poboljšanje u rasponu pokreta u odnosu na početno stanje; vidjeti tablicu 6.
• disease of the lymph vessels 
• bolest limfnih žila
The efficacy of Xiapex 0.58 mg was evaluated in two pivotal randomized, double-blind, placebo-controlled studies, CORD I (AUX-CC-857) and CORD II (AUX-CC-859), in adult patients with Dupuytren's contracture. 
placebom kontrolirana ispitivanja, CORD I (AUX-CC-857) i CORD II (AUX-CC-859), u odraslih bolesnika s Dupuytrenovom kontrakturom.
• To return to see their physician approximately 24-72 hours after injection for an examination of the injected hand and a finger extension procedure to disrupt the cord. 
• približno 24-72 sata nakon injekcije posjete liječnika radi pregleda injicirane šake i postupka ekstenzije prsta da bi se razbio tračak.
a) 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. 
a) Prije primjene, bočicu koja sadrži liofilizirani prašak Xiapex i bočicu koja sadrži otapalo za rekonstituciju otopine izvadite iz hladnjaka i ostavite obje bočice na sobnoj temperaturi najmanje 15 minuta i ne dulje od 60 minuta.
Study 1 or 2 b Each PDQ assessment required subjects to have had vaginal intercourse in the 
Ispitanici su bili iz ITT populacije i primili su najmanje jednu dozu ispitivanog lijeka u Ispitivanju 1 ili 2 b Svaka procjena upitnikom PDQ zahtijevala je da ispitanici imaju vaginalni snošaj unutar 3 mjeseca prije ispunjavanja upitnika c Veći broj bodova označava teže simptome
• popping sound/sensation indicating penile fracture 
• pucketajući zvuk/osjećaj koji upućuje na prijelom penisa • povišen šećer u krvi
Xiapex must be administered by a physician appropriately trained in the correct administration of the medicinal product and experienced in the diagnosis and management of Dupuytren's disease. 
Xiapex mora primjenjivati liječnik s odgovarajućom obukom u ispravnoj primjeni lijeka i iskustvom u dijagnostici i liječenju Dupuytrenove bolesti.
If the cord has not disrupted after 3 attempts of extension, a follow-up visit may be scheduled approximately 4 weeks after the injection. 
Ako tračak nije raskinut nakon 3 pokušaja ekstenzije, može se dogovoriti kontrolni posjet otprilike
Do not attempt to disrupt the injected cord by self manipulation at any time. 
Nikad nemojte sami pokušavati raskinuti tračak u koji je ubrizgana injekcija.
Only doctors that have been appropriately trained in the correct use of Xiapex and are experienced in the management of Dupuytren's or Peyronie's disease are allowed to give you treatment. 
Smiju Vas liječiti samo liječnici s odgovarajućom obukom za ispravnu primjenu Xiapexa i iskustvom u liječenju Dupuytrenove ili Peyronijeve bolesti.
• Not attempt to disrupt the injected cord by self manipulation at any time. 
• nikada ne pokušavaju sami raskinuti injicirani tračak.
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). 
Otapalo: 3 ml otopine u bočici od prozirnog stakla (5 ml, staklo tipa I) s gumenim čepom,
In each treatment cycle, you will receive one injection of Xiapex, followed by a second injection on a separate day (1 to 3 days later). 
Xiapexa, a zatim još jednu neki drugi dan (1-3 dana kasnije).
• discomfort, injury, paralysis of the limb 
• nelagoda, ozljeda, paraliza uda
d Includes: contusion, ecchymosis, penile haemorrhage, and injection site haemorrhage. 
d Uključuje: kontuziju, ekhimozu, krvarenje penisa i krvarenje na mjestu injekcije.
• 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. 
(MP) i proksimalne interfalangealne (PIP) zglobove s Dupuytrenovom kontrakturom i za plak u Peyronijevoj bolesti.
• Information on the potential risk of matrix metalloproteinases (MMP) cross reactivity including the development of musculoskeletal syndrome and exacerbation/initiation of autoimmune disorders. 
• Informacije o mogućem riziku od ukrižene reaktivnosti matriksnih metaloproteinaza (MMP)
b Includes: injection site swelling, penile oedema, penile swelling, local swelling, scrotal swelling, 
b Uključuje: oticanje na mjestu injekcije, edem penisa, oticanje penisa, lokalno oticanje, oticanje skrotuma i edem na mjestu injekcije.
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. 
Peyronijevoj bolesti 65,5% bolesnika liječenih Xiapexom razvilo je hematom penisa i 14,5%
Xiapex powder is supplied in a clear glass vial (3 ml, type I glass) with rubber stopper, aluminium seal and flip-off cap (polypropylene). 
Xiapex prašak isporučuje se u bočici od prozirnog stakla (3 ml, staklo tipa I) s gumenim čepom,
Hypersensitivity Anaphylactic reaction 
Poremećaji imunološkog sustava preosjetljivost anafilaktička reakcija
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. 
Injekcija Xiapexa u Dupuytrenov tračak koji je većinom građen od intersticijskog kolagena tipa
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. 
Tijekom jednog terapijskog posjeta mogu se primijeniti injekcije u najviše dva tračka ili dva zahvaćena zgloba na istoj šaci u skladu s postupkom davanja injekcije.
• blister or redness/discolouration of the penis 
• mjehur ili crvenilo/promjena boje penisa
Data on the long-term recurrence rates following successful treatment with Xiapex are provided in Table 7. 
Podaci o stopama recidiva kontraktura u dugoročnom praćenju nakon uspješnog liječenja XIAPEXOM
The package leaflet is updated accordingly. 
Uputa o lijeku je odgovarajuće ažurirana.
Cases of digital phalangeal fractures have been reported after finger manipulation procedure. 
Nakon postupka ekstenzije prsta prijavljeni su slučajevi prijeloma falangi prsta.
• drainage from a blister on the penis 
• iscjedak iz mjehura na penisu
i) Discard the unused portion of the reconstituted solution and diluent after each injection. 
Nakon svake injekcije bacite neiskorišten dio rekonstituirane otopine i otapala.
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. 
Prije primjene, bočicu koja sadrži liofilizirani prašak Xiapex i bočicu koja sadrži otapalo za rekonstituciju otopine izvadite iz hladnjaka i ostavite obje bočice na sobnoj temperaturi najmanje 15 minuta i ne dulje od 60 minuta.
• swollen face 
• svrbež u šaci
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. 
Ukupni sigurnosni profil u bolesnika koji su primili dvije injekcije Xiapexa istovremeno u ispitivanju AUX-CC-867 bio je sličan bez obzira na vrijeme kada se nakon injekcije izvodio postupak ekstenzije prsta (tj. 24 sata, 48 sati ili ≥72 sata nakon injekcije).
Xiapex 0.9 mg powder for injection collagenase clostridium histolyticum Intralesional use 
Xiapex 0,9 mg prašak za injekciju kolagenaza clostridium histolyticum
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: 
Pomoću štrcaljke od 1 ml s oznakama na svakih 0,01 ml i igle promjera 27 G i duljine 1213 mm (nije priložena) izvucite odgovarajući volumen priloženog otapala:
g) Discard the syringe and needle used for reconstitution and the diluent vial. 
g) Štrcaljku i iglu koje ste upotrijebili za rekonstituciju te bočicu od otapala bacite.
The single dose vial containing Xiapex and the single dose vial containing the solvent for solution for injection for reconstitution must be refrigerated. 
Jednodozna bočica Xiapexa i jednodozna bočica koja sadrži otapalo za rekonstituciju otopine za injekciju moraju se čuvati u hladnjaku.
All Joints 
Svi zglobovi
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. 
Odmah nazovite svog liječnika ako Vam se javi bilo koji od sljedećih simptoma prijeloma penisa ili druge ozbiljne ozljede penisa: pucketajući zvuk ili osjećaj u penisu u erekciji, iznenadan gubitak mogućnosti zadržavanja erekcije, bol u penisu, ljubičaste modrice i oticanje penisa, otežano mokrenje ili krv u mokraći, nakupina krvi pod kožom na mjestu injekcije.
Drug hypersensitivity Anaphylactic reaction* 
Poremećaji imunološkog sustava preosjetljivost na lijek anafilaktička reakcija*
Questionnaire (PDQ) 
Peyronie's Disease Questionnaire, PDQ)
Penile Fracture (corporal rupture) or other serious injury to the penis has uncommonly occurred. 
Prijelom penisa (ruptura korpusa) ili druga ozbiljna ozljeda penisa bili su manje česti događaji.
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. 
>99% bolesnika liječenih Xiapexom razvilo je visok titar protutijela i na AUX-I i na AUX-II.
If the needle is in the proper location, there will be some resistance noted during the injection procedure. 
osjetit ćete blagi otpor tijekom postupka injiciranja.
There is no quantifiable systemic exposure following a single injection of Xiapex in patients with Dupuytren's contracture and only minimal and short-lived systemic exposure of Xiapex in patients with Peyronie's disease. 
Sistemska izloženost Xiapexu nakon jedne injekcije Xiapexa u bolesnika s Dupuytrenovom kontrakturom nije mjerljiva, a u bolesnika s Peyronijevom bolešću sistemska izloženost Xiapexu je minimalna i kratkotrajna.
Until advised by your doctor, do not flex or extend the fingers of the injected hand. 
Nemojte savijati niti ispružati prste ruke nakon injekcije dok Vam to ne savjetuje liječnik.
Peyronie's disease Penile Fracture (corporal rupture) or other serious injury to the penis 
Prijelom penisa (ruptura korpusa) ili druga ozbiljna ozljeda penisa
Caution should be exercised when Xiapex is administered to a breast-feeding woman. 
Potreban je oprez kod primjene Xiapexa u dojilja.
Inspect the solution visually for particulate matter and discolouration prior to administration. 
Prije primjene vizualno pregledajte otopinu na prisutnost čestica i promjenu boje.
Respiratory, thoracic and mediastinal disorders 
Poremećaji dišnog sustava, prsišta i sredoprsja dispneja hiperventilacija
9 subjects received commercial Xiapex and 1 subject had penile implant during the course of the non-treatment study (AUX-CC-810), and 12 subjects had prior surgical intervention for the treatment of Peyronie´s Disease. 
(AUX-CC-810), 9 ispitanika primilo je komercijalno dostupan Xiapex, jednom je ispitaniku ugrađen penilni implantat, dok je u 12 ispitanika prethodno provedena kirurška intervencija za liječenje
• The summary of product characteristics and the patient information leaflet. 
• Sažetak opisa svojstava lijeka i uputu o lijeku.
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. 
Klinička ispitivanja Xiapexa primijenjenog putem lokalne injekcije u Dupuytrenov tračak ili u
9 subjects received commercial Xiapex and 2 subjects had penile implant during the course of the non-treatment study (AUX-CC-810), and 18 subjects had prior surgical intervention for the treatment of Peyronie´s Disease. 
(AUX-CC-810), 9 ispitanika primilo je komercijalno dostupan Xiapex, dvama je ispitanicima ugrađen penilni implantat, dok je u 18 ispitanika prethodno provedena kirurška intervencija za liječenje
Skin disorder, nodule, granuloma, blister, irritation or oedema 
zatezanje kože, utrnulost, nadraženost ili čvoriće, svrbež, ranu
Frequency of side effects not known 
Nuspojave nepoznate učestalosti
• blood sugar increased 
• pojačano znojenje
Xiapex 0.9 mg powder and solvent for solution for injection collagenase clostridium histolyticum 
Xiapex 0,9 mg prašak i otapalo za otopinu za injekciju kolagenaza clostridium histolyticum
The MAH shall ensure that all physicians who are expected to prescribe/use Xiapex are appropriately trained in the correct administration of the medicinal product and experienced in the diagnosis and management of Dupuytren's contracture and Peyronie's disease. 
Xiapex budu odgovarajuće obučeni u ispravnoj primjeni lijeka i da imaju iskustva u dijagnosticiranju i liječenju Dupuytrenove kontrakture i Peyronijeve bolesti.
Your doctor will perform all injections of Xiapex. 
Sve injekcije Xiapexa dat će Vam Vaš liječnik.
• the percent change from baseline to Week 52 in penile curvature deformity and 
• postotak promjene deformirajuće zakrivljenosti penisa od početka ispitivanja do 52. tjedna i
-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. 
ANOVA modelu s faktorima za liječenje i stratumom početne zakrivljenosti penisa te njihovom interakcijom uz primjenu LOCF metode (metoda prijenosa posljednjeg zabilježenog rezultata) u modificiranoj ITT populaciji (modificirana populacija koju se namjeravalo liječiti, mITT).
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. 
Ruptura korpusa zabilježena je kao ozbiljna nuspojava nakon injekcije Xiapexa u 5 od 1044 bolesnika
• joint injury 
• ozljeda zgloba
Injection volume to deliver 
Injekcija Xiapexa u
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. 
Ciljno mjesto za primjenu lijeka u Peyronijevom plaku prepoznaje se kao točka najjače udubljenosti
The review of data presented in the PSUR for Xiapex, covering the period from 28 February 2018 to 27 February 2019, identified post-marketing and literature case reports of finger necrosis and/or amputation and of finger fractures in patients with Dupuytren's contracture treated with collagenase clostridium histolyticum. 
27. veljače 2019. otkrio je slučajeve nekroze i/ili amputacije prsta te prijeloma prsta u bolesnika s
• skin cut 
• oticanje lica
Injection site reaction, malaise, irritation, anaesthesia, desquamation, nodule or discoloration Cold intolerance of the treated fingers 
deskvamacija, čvorić ili promjena boje na mjestu injekcije nepodnošenje hladnoće u liječenim prstima
Eyelid oedema 
Poremećaji oka edem vjeđa
e) The penis should be in a flaccid state before Xiapex is injected. 
e) Prije injiciranja Xiapexa, penis treba biti u opuštenom stanju.
Each vial of powder contains 0.9 mg of collagenase clostridium histolyticum*. 
Jedna bočica praška sadrži 0,9 mg kolagenaze clostridium histolyticum*.
• constipation 
• osjetljivost
Mean Baseline (SD) Mean Final (SD) Mean increase (SD) 
Završni prosjek (SD)
• scrotal redness, swelling and pain 
• crvenilo, oticanje i bol u mošnji
• bruising 
• omaglica
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). 
Gumeni čep i okolnu površinu bočice koja sadrži Xiapex i bočice koja sadrži otapalo za rekonstituciju treba obrisati sterilnim alkoholom
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. 
AUX-CC-859) i kliničkim ispitivanjima istovremene primjene dvije injekcije u istu šaku (AUX-CC864, AUX-CC-867) nakon stavljanja lijeka u promet.
(containing 0.58 mg of Xiapex). 
0,25 ml rekonstituirane otopine (sadrži 0,58 mg Xiapexa).
In these studies, patients were given up to 4 treatment cycles of Xiapex or placebo (weeks 0, 6, 12, 18), and were followed in a non-treatment follow-up period (weeks 24-52). 
U ovim ispitivanjima bolesnici su primili najviše 4 ciklusa liječenja Xiapexom ili placebom (u 0.,
The joint to be treated (metacarpophalangeal [MP] or proximal interphalangeal [PIP]) should be confirmed and the volume of solvent required for reconstitution is determined by the type of joint (PIP joint requires a smaller volume for injection). 
Potrebno je potvrditi koji će se zglob liječiti (metakarpofalangealni [MP] ili proksimalni interfalangealni [PIP]), a volumen otapala potreban za rekonstituciju određen je vrstom zgloba (za PIP
• tenderness in ligament at base of penis 
• osjetljivost ligamenta kod korijena penisa
Each powder vial contains 0.9 mg collagenase clostridium histolyticum 
Jedna bočica praška sadrži 0,9 mg kolagenaze clostridium histolyticum
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) Rekonstituirana otopina Xiapexa može se čuvati na sobnoj temperaturi (20º do 25ºC) najviše jedan sat ili u hladnjaku na 2° do 8°C najviše 4 sata prije primjene.
Haematoma 
Mutagenost
VARIABLE 
OBLIK
Pigmentation disorder Skin hyperpigmentation 
granulom, mjehur, nadraženost ili edem poremećaj pigmentacije hiperpigmentacija kože
• swollen or enlarged glands near the elbow or under the arm 
• osjećaj bola u šaci, zapešću ili ruci • otečene ili povećane žlijezde blizu lakta ili u pazuhu