natgillin/translations-raw huggingface dataset:
-11.4% b a Mean percent change, treatment difference, 95% CI, and p-value were based on an ANOVA model with factors for treatment, stratum of baseline penile curvature, and their interaction and using last observation carried forward (LOCF) in the modified intent-to-treat (mITT) population.
-11,4 % b a Povprečna sprememba v odstotkih, razlika v zdravljenju, 95-odstotni IZ in vrednost p so temeljili na modelu ANOVA z dejavniki za zdravljenje, stratumom izhodiščne ukrivljenosti penisa in njihovo interakcijo ter z uporabo zadnjega opazovanja, prenesenega naprej (LOCF, last observation carried forward) v prilagojeni populaciji z namenom zdravljenja (mITT, modified intent-to-treat).
h) Upon complete withdrawal of the needle, apply gentle pressure at the injection site.
h) Po popolnem izvleku igle nežno pritisnite na mesto injiciranja.
Your doctor will inject Xiapex into the plaque that is causing your penis to curve.
Zdravnik vam bo zdravilo Xiapex injiciral v plak, ki povzroča ukrivljanje penisa.
b) Apply antiseptic at the site of the injection and allow the skin to dry.
b) Na mesto injiciranja nanesite antiseptik in počakajte, da se koža osuši.
Whilst there is no clinical evidence of an interaction between tetracycline and anthracycline/anthraquinolone antibiotics and anthraquinone derivatives and Xiapex, such derivatives have been shown to inhibit matrix metalloproteinase-mediated collagen degradation at pharmacologically relevant concentrations in vitro.
antraciklinskih/antrakinolonskih antibiotikov in derivatov antrakinona z zdravilom Xiapex, je bilo ugotovljeno, da ti derivati zavirajo razgradnjo kolagena z matrično metaloproteinazo pri farmakološko relevantnih koncentracijah in vitro.
Mean Baseline (SD) Mean Final (SD) Mean increase (SD)
povprečno izhodišče (SD) povprečna končna vrednost (SD) povprečno zvečanje (SD)
• Wearing gloves, grasp the plaque or indurated portion of the flaccid penis about 1 cm proximal and distal to the injection site.
• Oblecite rokavice in plak ali trdi del mlahavega penisa primite približno 1 cm proksimalno in distalno na mesto injiciranja.
These collagenases, referred to as AUX-I and AUX-II, are representative of the two major collagenase classes (Class I and
Ti dve kolagenazi, ki jih imenujemo AUX-I in AUX-II, sta predstavnici dveh glavnih razredov kolagenaz (razred I in razred II), ki jih izdeluje Clostridium histolyticum.
At the follow-up visit 1 to 3 days after the second injection of each treatment cycle, the trained physician should perform a penile modelling procedure on the flaccid penis to stretch and elongate the treated plaque that Xiapex has disrupted.
Ob kontrolnem obisku 1 do 3 dni po drugi injekciji vsakega cikla zdravljenja mora usposobljen zdravnik opraviti postopek modeliranja penisa pri mlahavem penisu, da zdravljeni plak, ki ga je zdravilo Xiapex prekinilo, razteza in podaljša.
-1.1 b a Mean change, treatment difference, 95% CI, and p-value all based on an ANOVA model with factors for treatment, stratum of baseline penile curvature, and their interaction and using last observation carried forward (LOCF) in the modified intent-to-treat (mITT) population.
-1,1 b a Povprečna sprememba, razlika v zdravljenju, 95-odstotni IZ in vrednost p so temeljili na modelu ANOVA z dejavniki za zdravljenje, stratumom izhodiščne ukrivljenosti penisa in njihovo interakcijo ter z uporabo zadnjega opazovanja, prenesenega naprej (LOCF, last observation carried forward) v prilagojeni populaciji z namenom zdravljenja (mITT, modified intent-to-treat).
Special penile conditions/diseases not studied in clinical trials Xiapex treatment in patients having a calcified plaque that could have interfered with the injection technique, chordee in the presence or absence of hypospadias, thrombosis of the dorsal penile artery and/or vein, infiltration by a benign or malignant mass resulting in penile curvature, infiltration by an infectious agent, such as in lymphogranuloma venereum, ventral curvature from any cause and isolated hourglass deformity of the penis has not been studied and treatment in these patients should be avoided.
Posebna stanja/bolezni penisa, ki jih v kliničnih preskušanjih niso preučili Zdravljenje z zdravilom Xiapex pri bolnikih s kalcificiranim plakom, ki bi lahko vplival na tehniko injiciranja, ukrivljenostjo penisa nazvdol v prisotnosti ali odsotnosti hipospadiaze, trombozo dorzalne arterije in/ali vene penisa, infiltracijo benigne ali maligne tvorbe, ki povzroča ukrivljenost penisa,
At baseline, penile pain was either not present or was mild in most (98%) patients.
Ob izhodišču pri večini bolnikov (98 %) bolečine v penisu ni bilo ali pa je bila blaga.
• To elevate the injected hand as much as possible until the day after the finger extension procedure.
• naj držijo zdravljeno roko dvignjeno, kolikor je možno, do dneva po postopku iztegovanja prstov.
After the injection, your doctor will place a dressing on your hand.
Po injiciranju vam bo zdravnik roko obvezal.
The recommended dose of Xiapex is 0.58 mg per injection administered into a Peyronie's plaque.
Priporočeni odmerek zdravila Xiapex je 0,58 mg na injekcijo v Peyroniejev plak.
A higher rate for skin laceration has been shown following two concurrent injections in the same hand in a controlled post-marketing trial (see also Section 4.8).
V nadzorovanem preskušanju po prihodu zdravila na trg se je pokazalo, da so po dveh sočasnih injekcijah v isto roko raztrganine kože pogostejše (glejte tudi poglavje 4.8).
Curvature*
Ukrivljenost*
The cake of lyophilized powder should be intact and white in colour.
Pogača liofiliziranega praška mora biti cela in bele barve.
Therefore, the use of Xiapex is not recommended in pregnancy and treatment should be postponed until after pregnancy.
Zato zdravila Xiapex ne uporabljajte v času nosečnosti in zdravljenje odložite do zaključka nosečnosti.
Prior to each treatment cycle, identify the treatment area as follows:
Določanje predela zdravljenja Pred začetkom cikla zdravljenja določite predel zdravljenja kot sledi:
In the Dupuytren's contracture clinical trials at 30 days post the first injection, 92% of patients had circulating antibodies detected against AUX-I and 86% of patients against AUX-II.
V kliničnih preskušanjih Dupuytrenove kontrakture so po 30 dneh po prvem injiciranju pri 92 % bolnikov zaznali cirkulirajoča protitelesa proti AUX-I in pri 86 % bolnikov proti AUX-II.
a Metacarpophalangeal joint; b Proximal interphalangeal joint; c 2 primary joints were excluded from the efficacy analysis (1 joint from the placebo group was not evaluated and 1 joint from the Xiapex treated group had a baseline contracture of 0 degrees before treatment).
a metakarpofalangealni sklep; b proksimalni interfalangealni sklep; c 2 primarna sklepa sta bila izključena iz analize učinkovitosti (1 sklep iz placebo skupine ni bil ocenjen in 1 sklep iz skupine, zdravljene z zdravilom Xiapex, je imel izhodiščno kontrakturo pred zdravljenjem 0 stopinj).
How Xiapex is used
Kako se uporablja zdravilo Xiapex
Clinical study experience with Xiapex is currently limited to four treatment cycles in which a total of 8 injections may be administered into the plaque causing the curvature.
Izkušnje iz kliničnih študij z zdravilom Xiapex so trenutno omejene na štiri cikle zdravljenja, v katerih se lahko v plak, ki povzroča ukrivljenost, aplicira skupno do 8 injekcij.
• upper respiratory infection
• okužba zgornjih dihal
Powder and solvent for solution for injection 1 vial of powder
prašek in vehikel za raztopino za injiciranje 1 viala praška
Based on the Patient Global Assessment of Treatment Satisfaction, more than 85% of subjects in the CORD I and CORD II studies reported either being quite satisfied or very satisfied with their treatment with Xiapex versus approximately 30% treated with placebo (p<0.001).
Na osnovi globalne ocene zadovoljnosti z zdravljenjem je več kot 85 % preskušancev v študijah CORD I in CORD II poročalo, da so bodisi precej zadovoljni bodisi zelo zadovoljni s svojim zdravljenjem z zdravilom
• fast heart rate
• hiter srčni utrip
Different Fingers, 1 MP, 1 PIP (n=58)
1 MP, 1 PIP (n = 58)
The symptoms of musculoskeletal syndrome could be joint or muscle pain, shoulder stiffness, hand swelling, fibrosis of the palms, and thickening or nodule forming of tendons.
Simptomi mišično-skeletnega sindroma so lahko: bolečina v sklepu ali mišicah, togost v rami, otekanje roke, razraščanje veziva v dlani in zadebelitev ali vozliči v kitah.
Most of the side effects that occurred in the clinical studies were mild or moderate in severity and most resolved within 2 weeks of the injection.
Večina neželenih učinkov, ki so se pojavili v kliničnih študijah, je bila po resnosti blaga ali zmerna in je večinoma izzvenela v 2 tednih od injiciranja.
Tell your doctor if you are thinking about receiving or have previously received Xiapex to treat a condition known as Dupuytren's contracture.
Zdravniku povejte, če ste že prejemali ali razmišljate o prejemanju zdravila Xiapex za zdravljenje bolezni, imenovane Dupuytrenova kontraktura.
• The solvent contains calcium chloride dihydrate, sodium chloride and water for injections.
• Vehikel vsebuje kalcijev klorid dihidrat, natrijev klorid in vodo za injekcije.
Most of the side effects that occurred in the clinical studies were mild or moderate in severity and were localised to the hand treated.
Večina neželenih učinkov, ki so se pojavili v kliničnih študijah, je bilo blagih do zmernih in omejenih na zdravljeno roko.
c) Use only the supplied diluent for reconstitution.
c) Uporabite samo priložen vehikel za rekonstitucijo.
Adverse reactions reported from the clinical programme are those that occurred in the Phase 3 double blind placebo-controlled studies for the treatment of Dupuytren's contracture in adult patients with a palpable cord (AUX-CC-857, AUX-CC-859) and the post-marketing clinical studies (AUX-CC-864, AUX-CC-867) for two concurrent injections in the same hand.
Neželeni učinki, o katerih so poročali v kliničnem programu, so tisti, ki so se pojavili v fazi 3 dvojno slepih, s placebom nadzorovanih študij za zdravljenje Dupuytrenove kontrakture pri odraslih bolnikih z otipljivim vozličem (AUX-CC-857, AUX-CC-859) in v kliničnih študijah AUX-CC-864, AUX-CC-867) iz obdobja trženja za dve sočasni injekciji v isto roko.
Low levels of Xiapex were quantifiable in the plasma of evaluable male patients for up to 30 minutes following administration of Xiapex into the penile plaque of patients with Peyronie's disease (see section 5.2).
V plazmi moških bolnikov, ki so bili primerni za ocenitev, so bile v 30 minutah po injiciranju zdravila Xiapex v plak penisa pri bolnikih s Peyroniejevo boleznijo merljive nizke ravni zdravila Xiapex (glejte poglavje 5.2).
The reconstituted solution of Xiapex must be clear.
Rekonstituirana raztopina zdravila Xiapex mora biti bistra.
Mean Change in Peyronie's Disease Bother Domain Score from Baseline to Week 52 - Studies 1 and 2
Povprečna sprememba rezultata Področja težav Peyroniejeve bolezni od izhodišča do 52. tedna - študiji 1 in 2 Študija 1
At five years after the initial injection of Xiapex, 92.8% and 93.4% of subjects were seropositive for anti-AUX-I and anti-AUX-II respectively.
Po petih letih po začetni injekciji zdravila Xiapex je bilo 92,8 % oseb seropozitivnih za anti-AUX-I in 93,4 % oseb je bilo seropozitivnih za anti-AUX-II.
• feeling of pain in the groin, shoulder, chest wall, or neck
• občutek bolečine v dimljah, rami, prsnem košu ali vratu;
• bruising or swelling of the penis and pain in the penis
• modrica ali oteklina penisa in bolečina v penisu
The rubber stopper and surrounding surface of the vial containing Xiapex and the vial containing the solvent for reconstitution should be swabbed with sterile alcohol (no other antiseptics must be used).
Gumijasti zamašek in površino okoli viale, ki vsebuje zdravilo Xiapex, in na viali, ki vsebuje vehikel za rekonstitucijo, je treba očistiti s sterilnim alkoholom (drugih razkužil se ne sme uporabiti).
The following information is intended for healthcare professionals only: Instructions for use and handling
Naslednje informacije so namenjene samo zdravstvenemu osebju: Navodila za uporabo in rokovanje z zdravilom Peyroniejeva bolezen
The incidence of skin laceration (29.1%) was higher for subjects treated with two concurrent injections of Xiapex in historically-controlled clinical study AUX-CC-867 compared with subjects treated with up to three single injections in the Phase 3 placebo-controlled pivotal studies in Dupuytren's contracture (CORD I and CORD II) (8.8%).
Incidenca raztrganja kože (29,1 %) je bila v klinični študiji AUX-CC-867, nadzorovani z obstoječimi podatki, večja za osebe, zdravljene z dvema sočasnima injekcijama zdravila Xiapex, v primerjavi z osebami, zdravljenimi z do tremi enkratnimi injekcijami v ključnih študijah 3. faze za Dupuytrenovo kontrakturo, nadzorovanih s placebom (CORD I in CORD II) (8,8 %).
Only stretch your penis if your penis is not hard (erect).
Penis nežno raztezajte 3-krat na dan. Penis si raztezajte le, če ni trd (v erekciji).
The patient should then be instructed to self-perform penile modelling activities at home each day for the 6-week period following the physician penile plaque modelling visit of each treatment cycle, according to the detailed instructions provided in the package leaflet.
Bolniku je treba dati navodila za samoizvajanje aktivnosti modeliranja penisa doma, vsak dan za obdobje 6 tednov po obisku vsakega cikla zdravljenja, na katerem zdravnik opravi modeliranje plaka penisa, v skladu s podrobnimi navodili v navodilu za uporabo.
In the double-blind portion of the three phase 3 placebo-controlled clinical studies in Dupuytren's contracture, 17% of Xiapex-treated patients had mild reactions (i.e. pruritus) after up to 3 injections.
V dvojno slepem delu treh kliničnih študij 3. faze za Dupuytrenovo kontrakturo, ki so bile nadzorovane s placebom, je imelo 17 % bolnikov, zdravljenih z zdravilom Xiapex, blage reakcije (npr. pruritus) po do 3 injekcijah.
• the percent change from baseline to Week 52 in penile curvature deformity and
• sprememba deformacije ukrivljenosti penisa v odstotkih od izhodišča do 52. tedna in
In the three double-blind, placebo-controlled phase 3 studies in Dupuytren's contracture, 73% of Xiapex-treated patients reported an ecchymosis or a contusion and 38% reported a haemorrhage at the injection site.
V treh dvojno slepih, s placebom nadzorovanih študijah 3. faze za Dupuytrenovo kontrakturo je 73 % bolnikov, ki so bili zdravljeni z zdravilom Xiapex, poročalo o pojavu ekhimoze ali kontuzije in 38 % o pojavu krvavitve na mestu injiciranja.
The section 4.8 of the SmPC is updated to include the adverse reactions “digital necrosis” and “digital fracture” with a frequency “not known”.
povzetka glavnih značilnosti zdravila se posodobi tako, da se vključijo neželeni učinki “nekroza prsta” in “zlom prsta” s pogostnostjo “neznana”.
If the solution contains particles, is cloudy or discoloured, it should not be injected.
Če raztopina vsebuje delce, je motna oziroma obarvana, je ne smete uporabiti.
Baseline, mean (SD) Day 31, mean (SD) Change, mean (SD) % Change, mean (SD)
izhodišče, povprečje (SD) 31. dan, povprečje (SD) sprememba, povprečje (SD) sprememba v %, povprečje
• if you are currently taking any anticoagulation medicines, you must not receive Xiapex within 7 days of last dose of your anticoagulation medicine.
• če trenutno jemljete kakršnakoli zdravila proti strjevanju krvi, zdravila Xiapex ne smete dobiti 7
Manufacturer Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
Izdelovalec Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Švedska
For cords affecting the PIP joint, perform the finger extension procedure when the MP joint is in the flexed position.
Za vozliče, ki prizadenejo PIP sklep, izvajajte postopek iztegovanja prstov, ko je MP sklep v skrčenem položaju.
At the follow-up visit approximately 24-72 hours after injection, determine if the contracture has resolved.
Na kontrolnem pregledu približno 24 - 72 ur po injiciranju preverite, ali je kontraktura odpravljena.
Local anaesthesia may be applied before the modelling if desired.
Pred modeliranjem se lahko po želji uporabi lokalni anestetik.
The recommended dose of Xiapex is 0.58 mg per injection into a palpable Dupuytren's cord.
Priporočeni odmerek zdravila Xiapex je 0,58 mg na injekcijo v otipljiv Dupuytrenov vozlič.
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.
Učinkovitost zdravila Xiapex 0,58 mg je bila ovrednotena v dveh ključnih randomiziranih, dvojno slepih, s placebom nadzorovanih študijah, CORD I (AUX-CC-857) in CORD II (AUX-CC-859), pri odraslih bolnikih z Dupuytrenovo kontrakturo.
Clinical study experience with Xiapex is currently limited to up to 3 injections per cord and up to a total of 8 injections in the hands.
Izkušnje iz kliničnih študij z zdravilom Xiapex so trenutno omejene na do 3 injiciranja na vozlič in do skupno 8 injiciranj v roki.
No dose adjustment is necessary in any special patient groups e.g., Elderly, Renally or Hepatically Impaired, by Gender or Race.
V nobeni od posebnih skupin bolnikov (npr. starostniki, bolniki z okvaro ledvic ali jeter, spol, rasa) ni potrebna prilagoditev odmerka.
Place the needle tip on the side of the target plaque in alignment with the point of maximal concavity.
Konico igle namestite ob strani ciljnega plaka, poravnanoo s točko največje vbokline.
The solvent should slowly be injected into the sides of the vial containing the lyophilised powder of Xiapex.
Vehikel morate počasi injicirati ob steno viale, ki vsebuje liofiliziran prašek zdravila Xiapex.
Your doctor will perform all injections of Xiapex.
Vsa injiciranja zdravila Xiapex bo opravil vaš zdravnik.
Calcium chloride dihydrate Sodium chloride Water for injections
vehikel kalcijev klorid dihidrat natrijev klorid voda za injekcije
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.
Zdravnik naj nadene rokavice in plak ali trdi del mlahavega penisa prime približno 1 cm proksimalno in distalno na mesto injiciranja.
• popping sound/sensation indicating penile fracture
• pokajoč zvok/občutek, ki kaže na zlom penisa
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton containing 1 vial of powder and 1 vial of solvent
PODATKI NA ZUNANJI OVOJNINI škatla, ki vsebuje 1 vialo praška in 1 vialo vehikla
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.
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.
• 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.
• 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.
• You should only gently straighten your penis if you have an erection that happens without any sexual activity (spontaneous erection).
• Penis si nežno ravnajte le, ko imate erekcijo, do katere pride brez spolne aktivnosti
Administration of regional anaesthesia (penile block) or topical anaesthesia could be applied prior to Xiapex injection when desired.
Po želji se lahko pred injiciranjem zdravila Xiapex uporabi regionalna anestezija (blokada penisa) ali topikalna anestezija.
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.
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.
• reactions at the injection site such as presence of a blister, swelling, itching or a solid raised area under the skin
• reakcije na mestu injiciranja, kot so mehur, oteklina, srbečica ali trd dvignjen predel pod kožo
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.
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.
N=247 N=247 N=51
N = 247 N = 247 N = 51 N = 43 N = 225 N = 180
c Includes: injection site pain, penile pain, and injection site discomfort.
c Vključuje: bolečino na mestu injiciranja, bolečino penisa in nelagodje na mestu injiciranja.
• scar tissue in penis
• brazgotinasto tkivo v penisu
Demographic and baseline characteristics Phase 3 Double-Blind, Placebo controlled studies (CORD I, CORD II)
Faza 3 dvojno slepih, s placebom nadzorovanih študij (CORD I, CORD II) SPREMENLJIVKA
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.
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.
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.
Če se vozlič ne prekine po treh poskusih iztegovanja na vozlič, je predviden kontrolni pregled približno 4 tedne po injiciranju.
Pack of 1 vial of powder and 1 vial of solvent
Pakiranje s po 1 vialo praška in 1 vialo vehikla
Xiapex was not associated with shortening of penile length in clinical trials in the treatment of Peyronie's disease.
Zdravilo Xiapex v kliničnih preskušanjih za zdravljenje Peyroniejeve bolezni ni bilo povezano s skrajšanjem dolžine penisa.
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.
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.
TREATED PRIMARY JOINTS
ZDRAVLJENI PRIMARNI SKLEPI
• muscle spasm, muscle weakness, musculoskeletal stiffness or discomfort
• okorelost, škripanje sklepov; • mišični krči, šibkost mišic, mišično-skeletna okorelost ali nelagodje;
g) Discard the syringe and needle used for reconstitution and the diluent vial.
g) Brizgo in iglo, ki ste ju uporabili za rekonstitucijo, in vialo z vehiklom zavrzite.
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.
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
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.
Zdravilo Xiapex mora dajati zdravnik, ki je ustrezno usposobljen za pravilno dajanje zdravila in ima izkušnje v diagnosticiranju in zdravljenju uroloških bolezni pri moških.