natgillin/translations-raw huggingface dataset:
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.
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.
Contact your doctor right away if you are concerned by increasing pain or symptoms in the fingers after the treatment.
Če ste zaskrbljeni zaradi vedno močnejše bolečine ali simptomov v prstih po zdravljenju,
Xiapex 0.9 mg powder for injection collagenase clostridium histolyticum Intralesional use
Xiapex 0,9 mg prašek za injekcijo kolagenaza clostridium histolyticum intralezijska uporaba
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.
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.
• 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
• 0,39 ml vehikla za vozliče, ki prizadenejo MP sklep pri Dupuytrenovi kontrakturi
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).
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.
• ringing in the ear
• zvonjenje v ušesih • oteklina trebuha
N=133 N=69 N=20 N=11
MP sklepia n = 133 n = 69 n = 20 n = 11
Gender, n (%) Male Female Family history of Dupuytren's disease, n
spol, n (%) moški ženski družinska anamneza Dupuytrenove bolezni, n da ne zdravnikova ocena stopnje resnosti ob izhodišču blaga zmerna huda ni podatka
Table 13: Long Term Efficacy variables - study AUX-CC-810 Baselinea
Preglednica 13: Spremenljivke dolgoročne učinkovitosti - študija AUX-CC-810 Izhodiščea vrednostb 2. leto 3. leto 4. leto 5. leto
XIAPEX N=202
Zdravilo XIAPEX n = 202
The following side effects have been seen with Xiapex:
Pri zdravilu Xiapex so opazili naslednje neželene učinke:
5.3 Preclinical safety data
5.3 Predklinični podatki o varnosti Toksičnost pri ponavljajočih odmerkih
If the cord has not disrupted after 3 attempts of extension, a follow-up visit may be scheduled approximately 4 weeks after the injection.
Če vozlič po 3 poskusih iztegovanja ni prekinjen, se lahko približno 4 tedne po injiciranju bolnika naroči na kontrolni obisk.
• 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.
• 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,
Severe penile haematoma including severe injection site haematoma were reported with the frequency very common.
Zelo pogosto so poročali o hudem hematomu penisa, vključno s hudim hematomom na mestu injiciranja.
Xiapex 0.9 mg powder and solvent for solution for injection
Xiapex 0,9 mg prašek in vehikel za raztopino za injiciranje
∗ reported from a post-marketing clinical study in a patient who had previous exposure to Xiapex for the treatment of Dupuytren's contracture.
* poročano v klinični študiji iz obdobja trženja zdravila pri bolniku, ki je bil zdravilu Xiapex predhodno izpostavljen zaradi zdravljenja Dupuytrenove kontrakture.
N=70 N=34 N=25 N=10
PIP sklepib n = 70 n = 34 n = 25 n = 10
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.
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.
CORD II Xiapex Placebo Xiapex Placebo
CORD II Xiapex placebo Xiapex placebo vsi sklepi n = 203 c n = 103 c n = 45 n = 21
Penile fracture (corporal rupture) or other serious injury to the penis
Zlom penisa (ruptura korpusa) ali druga resna poškodba penisa
Xiapex contains sodium
Zdravilo Xiapex vsebuje natrij
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).
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).
• 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 možnem tveganju navzkrižnih reakcij matričnih metaloproteinaz (MMP),
If the reconstituted Xiapex solution is refrigerated, allow this solution to return to room temperature for approximately 15 minutes before use.
Če rekonstituirano raztopino zdravila Xiapex hranite v hladilniku, jo je treba približno 15 minut pred uporabo pustiti, da se segreje na sobno temperaturo.
Xiapex significantly reduced patient-reported bother associated with Peyronie's disease compared with placebo (Table 10).
Zdravilo Xiapex je v primerjavi s placebom značilno zmanjšalo težave, povezane s Peyroniejevo boleznijo, o katerih so poročali bolniki (preglednica 10).
Peyronie's disease This condition does not occur in females.
Pri ženskah se to stanje ne pojavlja.
• small area of inflammation
• majhno območje vnetja • nočno potenje
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.
sklepov in 45,0 % ponovljenih PIP sklepov dosežen klinični uspeh po ponovnem zdravljenju z do tremi injekcijami zdravila Xiapex.
N=181 N=183 N=37
N = 181 N = 183 N = 37 N = 31 N = 167 N = 134
Grounds for the variation to the terms of the Marketing Authorisation
Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom
e) The penis should be in a flaccid state before Xiapex is injected.
e) Pred injiciranjem zdravila Xiapex mora biti penis v mlahavem stanju.
The package leaflet is updated accordingly.
Navodilo za uporabo se ustrezno posodobi.
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.
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.
Baseline Mean Mean Change a Treatment Difference (95% CI)
Povprečna sprememba v odstotkiha Razlika zdravljenja (95-odstotni IZ)
Marketing Authorisation Holder Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
Imetnik dovoljenja za promet z zdravilom Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Švedska
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) 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.
• disease of the lymph vessels
• bolezen limfnih žil
3 months prior to completion c Higher scores represent worse symptoms
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
This condition affects adult men, who have a ‘plaque' that can be felt and a curve to their erect penis.
Ta bolezen prizadene odrasle moške, kaže se v obliki ‘plaka', ki se ga lahko otipa, in z ukrivljenostjo penisa med erekcijo.
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.
9 oseb prejelo komercialno zdravilo Xiapex, 2 osebi sta imeli penilni vsadek, 18 oseb pa je imelo predhodni kirurški poseg za zdravljenje Peyroniejeve bolezni.
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).
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
b Includes: injection site swelling, penile oedema, penile swelling, local swelling, scrotal swelling,
b Vključuje: oteklino na mestu injiciranja, edem penisa, oteklino penisa, lokalno oteklino, oteklino skrotuma in edem na mestu injiciranja.
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.
Uporaba zdravila Xiapex pri bolnikih, ki so dobivali antikoagulante (z izjemo do 150 mg acetilsalicilne kisline na dan) v obdobju 7
The following information is intended for Peyronie's disease patients only:
Naslednje informacije so namenjene le bolnikom s Peyroniejevo boleznijo: Navodila za nežno raztezanje penisa
i) Discard the unused portion of the reconstituted solution and diluent after each injection.
i) Po vsakem injiciranju zavrzite neporabljeni delež rekonstituirane raztopine in vehikla.
Talk to your doctor or pharmacist before you are given Xiapex.
Pred apliciranjem zdravila Xiapex se posvetujte z zdravnikom ali farmacevtom.
Figure 4: Illustration how to straighten your penis
Slika 4: Prikaz poravnave penisa
The single dose vial containing Xiapex and the single dose vial containing the solvent for solution for injection for reconstitution must be refrigerated.
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.
• reactions at the injection site like pain, warmth, swelling, presence of a blister, redness of skin and/or skin rash
• reakcije na mestu injiciranja, na primer bolečina, toplota, oteklina, mehur, rdečina kože in/ali kožni izpuščaj;
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.
Zdravilo Xiapex mora dajati zdravnik, ki je ustrezno usposobljen za pravilno dajanje zdravila in ima izkušnje v diagnosticiranju in vodenju zdravljenja Dupuytrenove bolezni.
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:
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:
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.
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
• For cords affecting MP joints each dose is administered in an injection volume of 0.25 ml.
• Za vozliče, ki prizadenejo MP sklepe, za vsak odmerek uporabite volumen za injiciranje
Total ROM (°)
Skupaj RG (°)
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.
9 oseb prejelo komercialno zdravilo Xiapex, 1 oseba je imela penilni vsadek, 12 oseb pa je imelo predhodni kirurški poseg za zdravljenje Peyroniejeve bolezni.
• drainage from a blister on the penis
• izcedek iz mehurja na penisu
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.
Zdravijo vas lahko le zdravniki, ustrezno usposobljeni za pravilno uporabo zdravila Xiapex in z izkušnjami pri obravnavanju Dupuytrenove ali Peyroniejeve bolezni.
Penile Fracture (corporal rupture) or other serious injury to the penis has uncommonly occurred.
Do zloma penisa (rupture korpusa) ali drugih resnih poškodb penisa je prišlo občasno.
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:
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:
• superficial vein inflammation
• površinsko vnetje žil
If a satisfactory response has not been achieved, the injection and finger extension procedures may be repeated after approximately 4 weeks.
Injekcija in postopek iztegovanja prstov se lahko ponovita po približno 4 tednih, če ne pride do zadovoljivega odziva.
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