FrancophonIA/ELRC3.0 huggingface dataset:
English: The solvent should slowly be injected into the sides of the vial containing the lyophilised powder of Xiapex.
Slovenian: Vehikel morate počasi injicirati ob steno viale, ki vsebuje liofiliziran prašek zdravila Xiapex.
English: Your doctor will perform all injections of Xiapex.
Slovenian: Vsa injiciranja zdravila Xiapex bo opravil vaš zdravnik.
English: Calcium chloride dihydrate Sodium chloride Water for injections
Slovenian: vehikel kalcijev klorid dihidrat natrijev klorid voda za injekcije
English: Wearing gloves the physician should grasp the plaque or indurated portion of the flaccid penis about 1 cm proximal and distal to the injection site.
Slovenian: Zdravnik naj nadene rokavice in plak ali trdi del mlahavega penisa prime približno 1 cm proksimalno in distalno na mesto injiciranja.
English: • popping sound/sensation indicating penile fracture
Slovenian: • pokajoč zvok/občutek, ki kaže na zlom penisa
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton containing 1 vial of powder and 1 vial of solvent
Slovenian: PODATKI NA ZUNANJI OVOJNINI škatla, ki vsebuje 1 vialo praška in 1 vialo vehikla
English: If injecting into a cord affecting the PIP joint of the fifth (little) finger, care must be taken to inject as close to the palmar digital crease as possible and not to insert more than 2 mm to 3 mm in depth.
Slovenian: Če injicirate v vozlič, ki prizadene PIP sklep petega prsta (mezinca), morate biti previdni, da boste injicirali čim bliže palmarni digitalni gubi in vbod z iglo ne sme biti globlji od 2 do 3 mm. Za PIP sklepe mora biti vbod oddaljen manj kot 4 mm distalno od palmarne digitalne gube.
English: • To return to see their physician approximately 24-72 hours after each injection for an examination of the injected hand and a possible finger extension procedure to disrupt the cord.
Slovenian: • naj se vrnejo k svojemu zdravniku približno 24 - 72 ur po vsakem injiciranju, da jim bo pregledal zdravljeno roko in morda izvedel postopek iztegovanja prstov za prekinitev vozliča.
English: • You should only gently straighten your penis if you have an erection that happens without any sexual activity (spontaneous erection).
Slovenian: • Penis si nežno ravnajte le, ko imate erekcijo, do katere pride brez spolne aktivnosti
English: Administration of regional anaesthesia (penile block) or topical anaesthesia could be applied prior to Xiapex injection when desired.
Slovenian: Po želji se lahko pred injiciranjem zdravila Xiapex uporabi regionalna anestezija (blokada penisa) ali topikalna anestezija.
English: Due to the lack of quantifiable systemic exposure of Xiapex in patients with Dupuytren's contracture and minimal and short-lived systemic exposure of Xiapex in patients with Peyronie's disease, no dose adjustment is necessary.
Slovenian: Ker nivo sistemske izpostavljenosti zdravilu Xiapex pri bolnikih z Dupuytrenovo kontrakturo ni merljiv in je sistemska izpostavljenost zdravilu Xiapex pri bolnikih s Peyroniejevo boleznijo minimalna in kratkotrajna, prilagajanje odmerka ni potrebno.
English: • reactions at the injection site such as presence of a blister, swelling, itching or a solid raised area under the skin
Slovenian: • reakcije na mestu injiciranja, kot so mehur, oteklina, srbečica ali trd dvignjen predel pod kožo
English: Table 8 provides the baseline disease characteristics for the study population and Tables 9 -10 provide the results of the co-primary efficacy endpoints measured in the 2 double-blind placebo-controlled studies AUX-CC-803 and AUX-CC-804.
Slovenian: V preglednici 8 so značilnosti bolezni ob izhodišču za študijsko populacijo, v preglednicah 9 - 10 pa so rezultati sočasnih primarnih opazovanih dogodkov učinkovitosti, izmerjeni v 2 dvojno slepih, s placebom nadzorovanih študijah AUX-CC-803 in AUX-CC-804.
English: N=247 N=247 N=51
Slovenian: N = 247 N = 247 N = 51 N = 43 N = 225 N = 180
English: c Includes: injection site pain, penile pain, and injection site discomfort.
Slovenian: c Vključuje: bolečino na mestu injiciranja, bolečino penisa in nelagodje na mestu injiciranja.
English: • scar tissue in penis
Slovenian: • brazgotinasto tkivo v penisu
English: Demographic and baseline characteristics Phase 3 Double-Blind, Placebo controlled studies (CORD I, CORD II)
Slovenian: Faza 3 dvojno slepih, s placebom nadzorovanih študij (CORD I, CORD II) SPREMENLJIVKA
English: 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.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da so vsi zdravniki, ki bodo predvidoma predpisovali/uporabljali zdravilo Xiapex ustrezno usposobljeni za pravilno dajanje zdravila ter izkušeni v diagnostiki in obravnavi Dupuytrenove kontrakture in Peyroniejeve bolezni.
English: If the cord has not disrupted after 3 attempts of extension per cord, a follow-up visit may be scheduled approximately 4 weeks after the injection.
Slovenian: Če se vozlič ne prekine po treh poskusih iztegovanja na vozlič, je predviden kontrolni pregled približno 4 tedne po injiciranju.
English: Pack of 1 vial of powder and 1 vial of solvent
Slovenian: Pakiranje s po 1 vialo praška in 1 vialo vehikla
English: Xiapex was not associated with shortening of penile length in clinical trials in the treatment of Peyronie's disease.
Slovenian: Zdravilo Xiapex v kliničnih preskušanjih za zdravljenje Peyroniejeve bolezni ni bilo povezano s skrajšanjem dolžine penisa.
English: Two palpable cords affecting two joints may be injected or one palpable cord affecting two joints in the same finger may be injected at two locations during a treatment visit.
Slovenian: Med obiskom za zdravljenje se lahko injicirata dva otipljiva vozliča, ki prizadeneta dva sklepa, ali en otipljiv vozlič, ki prizadene dva sklepa v istem prstu na dveh mestih.
English: TREATED PRIMARY JOINTS
Slovenian: ZDRAVLJENI PRIMARNI SKLEPI
English: • muscle spasm, muscle weakness, musculoskeletal stiffness or discomfort
Slovenian: • okorelost, škripanje sklepov; • mišični krči, šibkost mišic, mišično-skeletna okorelost ali nelagodje;
English: g) Discard the syringe and needle used for reconstitution and the diluent vial.
Slovenian: g) Brizgo in iglo, ki ste ju uporabili za rekonstitucijo, in vialo z vehiklom zavrzite.
English: Because the collagen lysis process following Xiapex administration is localized and does not require or result in quantifiable systemic levels of AUX-I and AUX-II, the primary pharmacodynamic activity of Xiapex cannot be evaluated in subjects and therefore, such studies have not been undertaken.
Slovenian: Proces razgradnje kolagena, ki sledi aplikaciji zdravila Xiapex, je lokaliziran in ne zahteva ali vodi v merljive sistemske nivoje AUX-I in AUX-II, zato primarne farmakodinamične aktivnosti zdravila
English: Xiapex must be administered by a physician appropriately trained in the correct administration of the medicinal product and experienced in the diagnosis and treatment of male urological diseases.
Slovenian: Zdravilo Xiapex mora dajati zdravnik, ki je ustrezno usposobljen za pravilno dajanje zdravila in ima izkušnje v diagnosticiranju in zdravljenju uroloških bolezni pri moških.
English: The efficacy of Xiapex was evaluated in two randomized, double-blind, placebo-controlled studies, Study 1 (AUX-CC-803) and Study 2 (AUX-CC-804), in adult males with Peyronie's disease.
Slovenian: Peyroniejeva bolezen Učinkovitost zdravila Xiapex je bila ocenjena v dveh randomiziranih, dvojno slepih, s placebom nadzorovanih študijah, v študiji 1 (AUX-CC-803) in študiji 2 (AUX-CC-804), pri odraslih moških s Peyroniejevo boleznijo.
English: Contact your doctor right away if you are concerned by increasing pain or symptoms in the fingers after the treatment.
Slovenian: Če ste zaskrbljeni zaradi vedno močnejše bolečine ali simptomov v prstih po zdravljenju,
English: Xiapex 0.9 mg powder for injection collagenase clostridium histolyticum Intralesional use
Slovenian: Xiapex 0,9 mg prašek za injekcijo kolagenaza clostridium histolyticum intralezijska uporaba
English: The administration of two concurrent Xiapex injections into Dupuytren's cords in the same hand was evaluated in clinical study AUX-CC-867, a historically-controlled, open-label multi-centre trial in 715 adult subjects (1450 Xiapex injections) with Dupuytren's contracture.
Slovenian: Dajanje dveh sočasni injekcij zdravila Xiapex v Dupuytrenove vozličke v isto roko so ocenili v klinični študiji AUX-CC-867, z obstoječimi podatki nadzorovanem, odprtem multicentričnem preskušanju s 715 odraslimi osebami (1.450 injekcij zdravila Xiapex) z Dupuytrenovo kontrakturo.
English: • 0.39 ml of solvent for cords affecting a MP joint in Dupuytren's contracture • 0.31 ml of solvent for cords affecting a PIP joint in Dupuytren's contracture
Slovenian: • 0,39 ml vehikla za vozliče, ki prizadenejo MP sklep pri Dupuytrenovi kontrakturi
English: b) After removal of the flip-off cap from each vial, using aseptic technique swab the rubber stopper and surrounding surface of the vial containing Xiapex and the vial containing the diluent for reconstitution with sterile alcohol (no other antiseptics should be used).
Slovenian: b) Ko z vsake viale odstranite dvižno zaporko, z uporabo aseptične tehnike s sterilnim alkoholom (drugih razkužil se ne sme uporabiti) obrišite gumijasti zanašek in površino okoli viale, ki vsebuje zdravilo Xiapex, ter vialo, ki vsebuje vehikel za rekonstitucijo.
English: • ringing in the ear
Slovenian: • zvonjenje v ušesih • oteklina trebuha
English: N=133 N=69 N=20 N=11
Slovenian: MP sklepia n = 133 n = 69 n = 20 n = 11
English: Gender, n (%) Male Female Family history of Dupuytren's disease, n
Slovenian: spol, n (%) moški ženski družinska anamneza Dupuytrenove bolezni, n da ne zdravnikova ocena stopnje resnosti ob izhodišču blaga zmerna huda ni podatka
English: Table 13: Long Term Efficacy variables - study AUX-CC-810 Baselinea
Slovenian: Preglednica 13: Spremenljivke dolgoročne učinkovitosti - študija AUX-CC-810 Izhodiščea vrednostb 2. leto 3. leto 4. leto 5. leto
English: XIAPEX N=202
Slovenian: Zdravilo XIAPEX n = 202
English: The following side effects have been seen with Xiapex:
Slovenian: Pri zdravilu Xiapex so opazili naslednje neželene učinke:
English: 5.3 Preclinical safety data
Slovenian: 5.3 Predklinični podatki o varnosti Toksičnost pri ponavljajočih odmerkih
English: If the cord has not disrupted after 3 attempts of extension, a follow-up visit may be scheduled approximately 4 weeks after the injection.
Slovenian: Če vozlič po 3 poskusih iztegovanja ni prekinjen, se lahko približno 4 tedne po injiciranju bolnika naroči na kontrolni obisk.
English: • 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.
Slovenian: • naj pridejo na kontrolo k svojemu zdravniku približno 24 - 72 ur po injiciranju da jim bo pregledal roko in izvedel postopek iztegovanja prstov za prekinitev vozliča,
English: Severe penile haematoma including severe injection site haematoma were reported with the frequency very common.
Slovenian: Zelo pogosto so poročali o hudem hematomu penisa, vključno s hudim hematomom na mestu injiciranja.
English: Xiapex 0.9 mg powder and solvent for solution for injection
Slovenian: Xiapex 0,9 mg prašek in vehikel za raztopino za injiciranje
English: ∗ reported from a post-marketing clinical study in a patient who had previous exposure to Xiapex for the treatment of Dupuytren's contracture.
Slovenian: * poročano v klinični študiji iz obdobja trženja zdravila pri bolniku, ki je bil zdravilu Xiapex predhodno izpostavljen zaradi zdravljenja Dupuytrenove kontrakture.
English: N=70 N=34 N=25 N=10
Slovenian: PIP sklepib n = 70 n = 34 n = 25 n = 10
English: Prior to use, the vial containing Xiapex and the vial containing the solvent for solution for reconstitution must be removed from the refrigerator and allowed to stand at room temperature for at least 15 minutes and no longer than 60 minutes.
Slovenian: Pred uporabo je treba vialo, ki vsebuje zdravilo Xiapex, in vialo, ki vsebuje vehikel za raztopino za rekonstitucijo, vzeti iz hladilnika in pustiti na sobni temperaturi vsaj 15 minut in ne dlje kot 60 minut.
English: CORD II Xiapex Placebo Xiapex Placebo
Slovenian: CORD II Xiapex placebo Xiapex placebo vsi sklepi n = 203 c n = 103 c n = 45 n = 21
English: Penile fracture (corporal rupture) or other serious injury to the penis
Slovenian: Zlom penisa (ruptura korpusa) ali druga resna poškodba penisa
English: Xiapex contains sodium
Slovenian: Zdravilo Xiapex vsebuje natrij
English: Injection of Xiapex into collagen-containing structures such as the corpora cavernosa of the penis may result in damage to those structures and possible injury such as corporal rupture (penile fracture).
Slovenian: Ruptura korpusa (zlom penisa) ali druge resne poškodbe penisa pri zdravljenju Peyroniejeve bolezni Injiciranje zdravila Xiapex v strukture, ki vsebujejo kolagen, kot sta kavernozni telesi penisa, lahko povzročijo okvare teh struktur in morebitne poškodbe, kot je ruptura korpusa (zlom penisa).
English: • Information on the potential risk of matrix metalloproteinases (MMP) cross reactivity including the development of musculoskeletal syndrome and exacerbation/initiation of autoimmune disorders.
Slovenian: • informacije o možnem tveganju navzkrižnih reakcij matričnih metaloproteinaz (MMP),
English: If the reconstituted Xiapex solution is refrigerated, allow this solution to return to room temperature for approximately 15 minutes before use.
Slovenian: Če rekonstituirano raztopino zdravila Xiapex hranite v hladilniku, jo je treba približno 15 minut pred uporabo pustiti, da se segreje na sobno temperaturo.
English: Xiapex significantly reduced patient-reported bother associated with Peyronie's disease compared with placebo (Table 10).
Slovenian: Zdravilo Xiapex je v primerjavi s placebom značilno zmanjšalo težave, povezane s Peyroniejevo boleznijo, o katerih so poročali bolniki (preglednica 10).
English: Peyronie's disease This condition does not occur in females.
Slovenian: Pri ženskah se to stanje ne pojavlja.
English: • small area of inflammation
Slovenian: • majhno območje vnetja • nočno potenje
English: In study AUX-CC-862, 64.5% of recurrent MP joints and 45.0% of recurrent PIP joints achieved clinical success after retreatment with up to three injections of Xiapex.
Slovenian: sklepov in 45,0 % ponovljenih PIP sklepov dosežen klinični uspeh po ponovnem zdravljenju z do tremi injekcijami zdravila Xiapex.
English: N=181 N=183 N=37
Slovenian: N = 181 N = 183 N = 37 N = 31 N = 167 N = 134
English: Grounds for the variation to the terms of the Marketing Authorisation
Slovenian: Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom
English: e) The penis should be in a flaccid state before Xiapex is injected.
Slovenian: e) Pred injiciranjem zdravila Xiapex mora biti penis v mlahavem stanju.
English: The package leaflet is updated accordingly.
Slovenian: Navodilo za uporabo se ustrezno posodobi.
English: 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.
Slovenian: Ni merljive sistemske izpostavljenosti po enkratnem injiciranju zdravila Xiapex pri bolnikih z Dupuytrenovo kontrakturo, pri bolnikih s Peyroniejevo boleznijo pa je izpostavljenost zdravilu Xiapex le minimalna in kratkotrajna.
English: Baseline Mean Mean Change a Treatment Difference (95% CI)
Slovenian: Povprečna sprememba v odstotkiha Razlika zdravljenja (95-odstotni IZ)
English: Marketing Authorisation Holder Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
Slovenian: Imetnik dovoljenja za promet z zdravilom Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Švedska
English: 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.
Slovenian: a) 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.
English: • disease of the lymph vessels
Slovenian: • bolezen limfnih žil
English: 3 months prior to completion c Higher scores represent worse symptoms
Slovenian: ali 2 b Pri vsaki oceni PDQ se je od osebe zahtevalo, da ima v 3 mesecih pred izpolnitvijo vaginalni spolni odnos c Višji rezultati predstavljajo slabše simptome
English: This condition affects adult men, who have a ‘plaque' that can be felt and a curve to their erect penis.
Slovenian: Ta bolezen prizadene odrasle moške, kaže se v obliki ‘plaka', ki se ga lahko otipa, in z ukrivljenostjo penisa med erekcijo.
English: 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.
Slovenian: 9 oseb prejelo komercialno zdravilo Xiapex, 2 osebi sta imeli penilni vsadek, 18 oseb pa je imelo predhodni kirurški poseg za zdravljenje Peyroniejeve bolezni.
English: 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).
Slovenian: Sklep, ki ga boste zdravili (metakarpofalangealni [MP] ali proksimalni interfalangealni [PIP]), je treba potrditi in volumen vehikla, ki je potreben za rekonstitucijo, se določi glede na vrsto sklepa (za PIP
English: b Includes: injection site swelling, penile oedema, penile swelling, local swelling, scrotal swelling,
Slovenian: b Vključuje: oteklino na mestu injiciranja, edem penisa, oteklino penisa, lokalno oteklino, oteklino skrotuma in edem na mestu injiciranja.
English: Use of Xiapex in patients who have received anticoagulants (with the exception of up to 150 mg acetylsalicylic acid daily) within 7 days prior to receiving an injection of Xiapex is not recommended.
Slovenian: Uporaba zdravila Xiapex pri bolnikih, ki so dobivali antikoagulante (z izjemo do 150 mg acetilsalicilne kisline na dan) v obdobju 7
English: The following information is intended for Peyronie's disease patients only:
Slovenian: Naslednje informacije so namenjene le bolnikom s Peyroniejevo boleznijo: Navodila za nežno raztezanje penisa
English: i) Discard the unused portion of the reconstituted solution and diluent after each injection.
Slovenian: i) Po vsakem injiciranju zavrzite neporabljeni delež rekonstituirane raztopine in vehikla.
English: Talk to your doctor or pharmacist before you are given Xiapex.
Slovenian: Pred apliciranjem zdravila Xiapex se posvetujte z zdravnikom ali farmacevtom.
English: Figure 4: Illustration how to straighten your penis
Slovenian: Slika 4: Prikaz poravnave penisa
English: The single dose vial containing Xiapex and the single dose vial containing the solvent for solution for injection for reconstitution must be refrigerated.
Slovenian: Viala za enkratno uporabo, ki vsebuje zdravilo Xiapex, in viala za enkratno uporabo, ki vsebuje vehikel za raztopino za injiciranje za rekonstitucijo, morata biti shranjeni v hladilniku.
English: • reactions at the injection site like pain, warmth, swelling, presence of a blister, redness of skin and/or skin rash
Slovenian: • reakcije na mestu injiciranja, na primer bolečina, toplota, oteklina, mehur, rdečina kože in/ali kožni izpuščaj;
English: 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.
Slovenian: Zdravilo Xiapex mora dajati zdravnik, ki je ustrezno usposobljen za pravilno dajanje zdravila in ima izkušnje v diagnosticiranju in vodenju zdravljenja Dupuytrenove bolezni.
English: Using a new sterile, hubless syringe with 0.01 ml graduations and a permanently fixed, 26 or 27 gauge, 12 or 13 mm needle (not supplied), withdraw the adequate volume of reconstituted solution for a 0.58 mg dose of Xiapex required for injection to deliver:
Slovenian: 12 ali 13-milimetrske igle velikosti G 26 ali 27 (ni priložena) izvlecite ustrezen volumen rekonstituirane raztopine za odmerek zdravila Xiapex 0,58 mg, ki je potreben za injiciranje, da dobite:
English: A significant mean improvement (74.4%) from baseline to Day 31 was observed overall in fixed flexion contracture following administration of two concurrent injections of Xiapex 0.58 mg (one injection per joint) in the same hand, see Table 6.
Slovenian: Značilno povprečno izboljšanje (74,4 %) od izhodišča do 31. dne so na splošno opazili v popravljeni fleksijski kontrakturi po dajanju dveh sočasnih injekcij zdravila Xiapex
English: • For cords affecting MP joints each dose is administered in an injection volume of 0.25 ml.
Slovenian: • Za vozliče, ki prizadenejo MP sklepe, za vsak odmerek uporabite volumen za injiciranje
English: Total ROM (°)
Slovenian: Skupaj RG (°)
English: 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.
Slovenian: 9 oseb prejelo komercialno zdravilo Xiapex, 1 oseba je imela penilni vsadek, 12 oseb pa je imelo predhodni kirurški poseg za zdravljenje Peyroniejeve bolezni.
English: • drainage from a blister on the penis
Slovenian: • izcedek iz mehurja na penisu
English: 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.
Slovenian: Zdravijo vas lahko le zdravniki, ustrezno usposobljeni za pravilno uporabo zdravila Xiapex in z izkušnjami pri obravnavanju Dupuytrenove ali Peyroniejeve bolezni.
English: Penile Fracture (corporal rupture) or other serious injury to the penis has uncommonly occurred.
Slovenian: Do zloma penisa (rupture korpusa) ali drugih resnih poškodb penisa je prišlo občasno.
English: d) 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:
Slovenian: d) Uporabite 1 ml brizgo, ki ima oznake po 0,01 ml in 12-13 mm iglo velikosti G27 (ni priložena) ter izvlecite pravilni volumen priloženega vehikla:
English: • superficial vein inflammation
Slovenian: • površinsko vnetje žil
English: If a satisfactory response has not been achieved, the injection and finger extension procedures may be repeated after approximately 4 weeks.
Slovenian: Injekcija in postopek iztegovanja prstov se lahko ponovita po približno 4 tednih, če ne pride do zadovoljivega odziva.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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.