natgillin/translations-raw huggingface dataset:
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 zglob; b Proksimalni interfalangealni zglob; c 2 primarna zgloba bila su isključena iz analize djelotvornosti (1 zglob iz skupine koja je primala placebo nije bio procijenjen i 1 zglob iz skupine liječene Xiapexom imao je početnu kontrakturu od 0 stupnjeva prije liječenja).
• Wear the splint at bedtime for up to 4 months.
• Da nose udlagu tijekom spavanja do 4 mjeseca.
All Joints p-value
Svi zglobovi p-vrijednost
Withdraw the needle slowly so as to deposit the full dose along the needle track within the plaque.
Polako izvlačite iglu tako da injicirate čitavu dozu duž puta koji igla prijeđe unutar plaka.
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.
Klinički uspjeh (smanjenje kontrakture na ≤5° unutar 30 dana) nakon dvije istovremeno primijenjene injekcije Xiapexa (jedna po zglobu) u istu šaku postignut je u većine MP zglobova (64,6%) u usporedbi s 28.6% PIP zglobova nakon jedne injekcije po zahvaćenom zglobu.
In addition, based on the review of post marketing case reports of penile fracture in patients with Peyronie's disease, the PRAC considers that the product information for Xiapex should be updated to include a new wording for section 4.4 of the SmPC and section 2 of the PIL to increase the minimum time span between injection and resumption of sexual activity to at least 4 weeks and to be cautious when resuming sexual activity.
Povrh toga, na temelju pregleda prikaza slučajeva iz razdoblja nakon stavljanja lijeka u promet o prijelomu penisa u bolesnika s Peyronijevom bolešću, PRAC smatra da je potrebno ažurirati informacije o lijeku za Xiapex kako bi uključile novi opis u dijelu 4.4 Sažetka opisa svojstava lijeka i u dijelu 2 Upute o lijeku na način da se poveća minimalno razdoblje između injekcije i nastavka seksualne aktivnosti na najmanje 4 tjedna te navede da je potreban oprez kod nastavka seksualne aktivnosti.
Post-treatment surgery The impact of treatment with Xiapex on subsequent surgery, if needed, is not known.
Nije poznat učinak liječenja Xiapexom na naknadno operativno liječenje, ako bude potrebno.
Xiapex should be injected into the target plaque when the penis is in a flaccid state.
Xiapex je potrebno injicirati u ciljni plak dok je penis u opuštenom stanju.
Avoid having the needle tip pass completely through the cord to help minimise the potential for injection of Xiapex into tissues other than the cord.
Pazite da vrškom igle potpuno ne probijete tračak kako biste minimalizirali mogućnost da injekciju Xiapexa date u neko drugo tkivo umjesto tračka.
Severe allergic reactions can happen in patients who receive Xiapex, because it contains proteins foreign to the human body.
U bolesnika koji prime Xiapex može doći do teških alergijskih reakcija jer sadrži protein stran ljudskom tijelu.
Recurrence was assessed in successfully treated joints (i.e., subjects had a reduction in contracture to 5° or less at the Day 30 evaluation after the last injection of Xiapex in a previous study) and was defined as an increase in joint contracture by at least 20° in the presence of a palpable cord, or the joint underwent medical or surgical intervention primarily to correct a new or worsening Dupuytren's contracture in that joint.
Recidiv kontrakture bio je procijenjen na uspješno liječenim zglobovima (tj. ispitanicima koji su postigli smanjenje kontrakture na 5° ili manje na procjeni 30. dana nakon posljednje injekcije Xiapexa u prethodnom ispitivanju) i bio je definiran kao povećanje kontrakture zgloba za najmanje 20° u prisutnosti opipljivog tračka ili podvrgavanje zgloba medicinskom ili kirurškom zahvatu prvenstveno zato da bi se ispravila nova Dupuytrenova kontraktura ili njeno pogoršanje na tom zglobu.
Injections and finger extension procedures may be administered up to 3 times per cord at approximately 4-week intervals.
Injekcije i postupak ekstenzije prsta mogu se ponoviti do 3 puta po tračku u razmacima od približno 4 tjedna.
Injection procedure
Postupak injiciranja
Injection site reactions were very common, occurring in the vast majority of patients, were mostly mild to moderate in severity and generally subsided within 1-2 weeks post injection.
Reakcije na mjestu injekcije, koje su bile vrlo česte i nastale su u goleme većine bolesnika, uglavnom su bile blage do umjerene težine i općenito su se povlačile u roku od 1-2 tjedna nakon injekcije.
Xiapex demonstrated a clinically significant benefit compared to placebo in the proportion of patients achieving the primary endpoint of a reduction in the contracture of all joints treated to 5° or less, approximately 4 weeks after the last injection (MP plus PIP, MP only, PIP only).
Xiapex je pokazao klinički značajnu korist u usporedbi s placebom u jednom postotku bolesnika koji su postigli primarni ishod smanjenja kontrakture svih liječenih zglobova na 5° ili manje, približno 4 tjedna nakon posljednje injekcije (MP plus PIP, samo MP, samo PIP).
Xiapex is a lyophilized product for parenteral administration containing collagenase clostridium histolyticum which is comprised of two collagenases in a defined mass ratio.
Xiapex je liofilizirani lijek za parenteralnu primjenu koji sadrži kolagenazu clostridium histolyticum koja se sastoji od dvije kolagenaze u definiranom masenom omjeru.
a A joint was considered in an interval if the duration of assessment falls in the interval.
a Zglob je ubrojen u pojedino razdoblje ako je trajanje procjene padalo u to razdoblje.
• shortness of breath, hyperventilation
• nedostatak zraka (zaduha), hiperventilacija
The active substance in Xiapex is collagenase clostridium histolyticum, and this collagenase is produced using the microorganism Clostridium histolyticum.
Djelatna tvar u Xiapexu je kolagenaza clostridium histolyticum, a ta se kolagenaza proizvodi pomoću mikroorganizma Clostridium histolyticum.
• skin wound, blood blister
• rana na koži, krvavi mjehur
This medicine must only be injected into the collagen cord in your hand by your doctor.
Ovaj lijek smije ubrizgati samo Vaš liječnik i to samo u kolagenski tračak u Vašoj ruci.
Following each of two intralesional administrations, separated by 24 hours, of Xiapex 0.58 mg into the penile plaque of 19 patients with Peyronie's disease, plasma levels of AUX-I and AUX-II in patients with quantifiable levels (82% and 40% for AUX-I and AUX-II, respectively) were minimal and shortlived.
Nakon svake od ukupno dvije intralezijske primjene 0,58 mg Xiapexa u plak penisa u razmaku od 24 sata u 19 bolesnika s Peyronijevom bolešću, razine AUX-I i AUX-II u plazmi bolesnika s mjerljivim razinama (82% za AUX-I i 40% za AUX-II) bile su minimalne i kratkotrajne.
There are no known interactions with concomitant use of medicines for erectile dysfunction and Xiapex treatment.
Nema poznatih interakcija pri primjeni lijekova za erektilnu disfunkciju istovremeno s liječenjem Xiapexom.
Baseline disease characteristics of patientsa with Peyronie's Disease (PD)
Početna obilježja bolesnikaa s Peyronijevom bolešću (PB)
• Not perform strenuous activity with the injected hand until advised to do so.
• ne obavljaju teške aktivnosti injiciranom šakom dok im se ne savjetuje drugačije.
• collection of blood outside the blood vessels
• nakupljanje krvi izvan krvnih žila
Treatment of two concurrent injections
Liječenje istovremenom primjenom dvije injekcije
• increased liver enzymes
• povišeni jetreni enzimi
Diagnostic imaging is recommended after manipulation if finger deformity, pain or increased swelling develops (see also section 4.8).
Ako se nakon ekstenzije razvije deformacija, bol ili pojačano oticanje prsta, preporučuje se dijagnostičko oslikavanje (vidjeti i dio 4.8).
Following this disruption of the plaque, penile curvature deformity and patient bother caused by Peyronie's disease are reduced.
Nakon razgradnje plaka smanjena je deformirajuća zakrivljenost penisa i bolesnikove tegobe uzrokovane Peyronijevom bolešću.
The study inclusion and exclusion criteria as well as the treatment schedule and the co-primary efficacy endpoints were the same as in the pivotal AUX-CC-803 and AUX-CC-804 studies.
Kriteriji uključenja i isključenja u tom ispitivanju, kao i raspored liječenja i koprimarni ishodi djelotvornosti bili su isti kao i u pivotalnim ispitivanjima AUX-CC-803 i AUX-CC-804.
Call your doctor right away if you experience any of the symptoms of penile fracture or serious injury to your penis listed above, as this may require surgical intervention.
Odmah se javite svom liječniku ako Vam se javi bilo koji od gore nabrojenih simptoma prijeloma penisa ili ozbiljne ozljede penisa, jer to može zahtijevati kiruršku intervenciju.
If the disease has resulted in multiple contractures, additional cords may be treated at other treatment visits approximately 4 weeks apart, as determined by your doctor.
Ako je bolest dovela do nastanka višestrukih kontraktura, dodatni tračci mogu se liječiti prilikom drugih terapijskih posjeta u razmaku od približno 4 tjedna, kako odredi Vaš liječnik.
Therefore, Xiapex must be injected only into the Peyronie's plaque and care should be taken to avoid injecting into the urethra, nerves, blood vessels, corpora cavernosa or other collagen-containing structures of the penis.
Xiapex mora injicirati samo u Peyronijev plak i treba paziti da ga se ne bi injiciralo u uretru, živce, krvne žile, kavernozna tijela ili druge strukture penisa koje sadrže kolagen.
Administration of regional anaesthesia (penile block) or topical anaesthesia could be applied prior to Xiapex injection when desired.
Po želji, može se primijeniti regionalna (penilni blok) ili topikalna anestezija prije injekcije Xiapexa.
A penile modelling procedure was performed on patients at the study site 1 to 3 days after the second injection of the cycle.
Postupak modeliranja penisa proveden je bolesnicima u ispitivačkom centru 1 do 3 dana nakon druge injekcije u ciklusu.
h) Upon complete withdrawal of the needle, apply gentle pressure at the injection site.
h) Nakon završenog izvlačenja igle, nježno pritisnite mjesto injekcije.
c) Use only the supplied diluent for reconstitution.
c) Upotrijebite samo priloženo otapalo za rekonstituciju.
Instructions on how to gently straighten your penis Gently straighten your penis one time a day.
Upute za nježno istezanje penisa Nježno istegnite svoj penis 3 puta na dan.
Please consult a doctor immediately if you experience any signs or symptoms of a serious allergic reaction, e.g., wide spread redness or rash, swelling, tightness in the throat or difficulty breathing.
Molimo odmah potražite savjet liječnika ako osjetite ikakve znakove ili simptome ozbiljne alergijske reakcije, npr. prošireno crvenilo ili osip, otečenost, stezanje u grlu ili otežano disanje.
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.
Ako se injekcija daje u tračak koji zahvaća PIP zglob petog (malog) prsta, treba paziti da se ubrizga što bliže palmarnodigitalnoj brazdi i ne uvede dublje od 2 mm do 3 mm.
Xiapex is supplied in a pack containing 1 vial of Xiapex powder and 1 vial of solvent.
Xiapex se isporučuje u pakiranju koje sadrži 1 bočicu praška Xiapex i 1 bočicu otapala.
At a follow-up visit 1 to 3 days after the second injection of each treatment cycle, perform a penile modelling procedure (as described below) on the flaccid penis to stretch and elongate the plaque that Xiapex has disrupted:
Na kontrolnom posjetu 1 do 3 dana nakon druge injekcije svakog ciklusa liječenja, provedite postupak modeliranja penisa (kako je opisano niže) na opuštenom penisu kako bi se plak razgrađen Xiapexom rastegnuo i produljio:
If the disease has resulted in multiple contractures, additional cords may be treated at other treatment visits approximately 4 weeks apart.
Ako je bolest dovela do višestrukih kontraktura, dodatni tračci mogu se liječiti prilikom drugih terapijskih posjeta u razmaku od približno 4 tjedna.
A higher incidence of skin laceration may be attributable to more vigorous finger extension procedures in patients after receiving anaesthesia to the hand.
Viša incidencija laceracije kože može se pripisati žustrijim postupcima ekstenzije prsta u bolesnika nakon što su dobili anesteziju u šaku.
• the change from baseline to Week 52 in the Bother domain of the Peyronie's Disease
• promjena od početka ispitivanja do 52. tjedna u dijelu "tegobe" upitnika za Peyronijevu bolest
• With one hand, hold the tip of your penis with your fingers.
• Prstima jedne ruke držite vrh penisa.
Treatment of Peyronie's plaques that involve the penile urethra due to potential risk to this structure.
Liječenje Peyronijevog plaka koji zahvaća uretru, zbog mogućeg rizika za uretru.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton containing 1 vial of powder and 1 vial of solvent
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija koja sadrži 1 bočicu praška i 1 bočicu otapala
Your doctor will ask you to return approximately 24-72 hours after your injection to attempt to extend your finger to straighten it.
Liječnik će Vam reći da se vratite približno 24-72 sata nakon injekcije kako bi Vam pokušao ispraviti prst, tako da ga možete ispružiti.
Blood glucose increased Blood pressure systolic increased
Pretrage povišena glukoza u krvi povišen sistolički krvni tlak povišena tjelesna temperatura
Primary efficacy endpoint was fixed flexion contracture in the treated joint pair subgroup.
Primarni ishod djelotvornosti bio je fiksna fleksijska kontraktura u podskupini s liječenim parom zglobova.
A finger extension procedure was performed if needed, approximately 24 hours after injection to facilitate disruption of the cord.
Postupak ekstenzije prsta napravljen je po potrebi, približno 24 sata nakon injekcije, kako bi se olakšalo razbijanje tračka.
Taking into account the plausibility of the mechanism of collagenase clostridium histolyticum and the subsequent manipulation procedure in patients with Dupuytren's contracture, the PRAC considers that the product information for Xiapex should be updated to include a warning with regards to finger necrosis resulting in some cases in finger amputation and a warning with regards to finger fracture should be included in section 4.4 of the SmPC.
Uzimajući u obzir vjerojatnost mehanizma djelovanja kolagenaze clostridium histolyticum i naknadni postupak ekstenzije prsta u bolesnika s Dupuytrenovom kontrakturom, PRAC smatra da je potrebno ažurirati informacije o lijeku za Xiapex kako bi u dijelu 4.4 Sažetka opisa svojstava lijeka uključile upozorenje o nekrozi prsta koja u nekim slučajevima rezultira amputacijom prsta, te upozorenje o prijelomu prsta.
If two cords of affected joints on the same hand are to be treated during a treatment visit, separate vials and syringes should be used for each reconstitution and injection.
Ako će se tijekom terapijskog posjeta liječiti dva tračka zahvaćenih zglobova na istoj šaci, za svaku rekonstituciju i injekciju treba uporabiti zasebne bočice i štrcaljke.
Sodium injected per joint in the treatment of Dupuytren's contracture: Metacarpophalangeal (MP) joints: 0.9 mg.
Natrij ubrizgan po zglobu kod liječenja Dupuytrenove kontrakture: Metakarpofalangealni (MP) zglobovi: 0,9 mg.
The Bother domain score is a composite of the following patient-reported items: concern about erection pain, erection appearance, and the impact of Peyronie's disease on intercourse and on frequency of intercourse.
U dijelu "tegobe" boduju se sljedeće sastavnice koje bolesnik zabilježi: zabrinutost zbog bolne erekcije, pojava erekcije i utjecaj Peyronijeve bolesti na snošaj i na učestalost snošaja.
• 0.25 ml of reconstituted Xiapex for cords affecting a MP joint or • 0.20 ml of reconstituted Xiapex for cords affecting a PIP joint.
• 0,25 ml rekonstituiranog Xiapexa u tračke koji zahvaćaju MP zglob ili • 0,20 ml rekonstituiranog Xiapex u tračke koji zahvaćaju PIP zglob.
In the Peyronie's disease clinical studies, at 6 weeks after the first treatment cycle of Xiapex, approximately 75% of patients had antibodies against AUX-I and approximately 55% of patients had antibodies against AUX-II.
U kliničkim ispitivanjima u Peyronijevoj bolesti 6 tjedana nakon prvog ciklusa liječenja Xiapexom, približno 75% bolesnika imalo je protutijela protiv AUX-I i približno 55% bolesnika imalo je protutijela protiv AUX-II.
The target plaque is used as a fulcrum point with both hands, to firmly apply a steady pressure to elongate and stretch the plaque.
Ciljni plak služi kao uporišna točka za obje ruke, kako bi se čvrsto primijenio ravnomjeran pritisak te produljio i rastegnuo plak.
In each treatment cycle, two injections of Xiapex 0.58 mg or two injections of placebo were administered 1 to 3 days apart.
svakom ciklusu liječenja primijenjene su dvije injekcije s 0,58 mg Xiapexa ili placeba u razmaku od 1 do 3 dana.
Xiapex must be used with caution in patients with coagulation disorders or those taking anticoagulants.
Primjena u bolesnika s poremećajima koagulacije Xiapex se mora primjenjivati s oprezom u bolesnika s poremećajima koagulacije i onih koji uzimaju antikoagulanse.
Tables 11-12 provide the results of the co-primary efficacy endpoints measured in the open label phase 3 study AUX-CC-806.
Tablice 11-12 prikazuju rezultate koprimarnih ishoda djelotvornosti mjerenih u ispitivanju faze 3 otvorenog tipa AUX-CC-806.
Tabulated list of adverse reactions Table 2 presents adverse reactions listed by system organ class and frequency categories, using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to
Tablica 2 prikazuje nuspojave prema klasifikaciji organskih sustava i kategorijama učestalosti sukladno sljedećoj konvenciji: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i
Neutralizing antibodies to AUX-I or AUX-II, were detected in 60% and 51.8%, respectively, of patients tested.
otkrivena su u 60% odnosno 51,8% testiranih bolesnika.
Injection of Xiapex into collagen containing structures may result in damage to those structures, and possible permanent injury such as tendon rupture or ligament damage.
Injekcija Xiapexa u strukture koje sadrže kolagen može rezultirati oštećenjem tih struktura i mogućom trajnom ozljedom, kao što je ruptura tetive ili oštećenje ligamenta.
• To promptly contact their doctor if there is evidence of infection (e.g., fever, chills, increasing redness or oedema) or trouble bending the finger after the swelling goes down (symptoms of tendon rupture).
• Da odmah posjete liječnika ako se pojave znakovi infekcije (npr., vrućica, zimica, pojačano crvenilo ili edem) ili ako je savijanje prsta otežano nakon što se oteklina povuče
There is no experience in the use of Xiapex in pregnant women therefore the use of Xiapex is not recommended in pregnancy, and treatment should be postponed until after pregnancy.
Nema iskustva s primjenom Xiapexa u trudnica pa se stoga ne preporučuje primjena Xiapexa u trudnoći, a liječenje treba odgoditi do razdoblja nakon trudnoće.
It is not known whether collagenase clostridium histolyticum is excreted in human milk.
Nije poznato izlučuje li se kolagenaza clostridium histolyticum u majčino mlijeko.
This medicine must only be injected into the plaque in your penis by your doctor.
Ovaj lijek smije ubrizgati samo Vaš liječnik i to samo u plak u Vašem penisu.
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.
U bolesnika s kalcificiranim plakom zbog kojeg se tehnika injiciranja ne bi mogla pravilno izvesti, bolesnika s tračcima uz hipospadiju ili bez nje, bolesnika s trombozom dorzalne arterije i/ili vene penisa, bolesnika u kojih je zakrivljenost penisa uzrokovana infiltracijom benignom ili malignom tumorskom masom, bolesnika s infektivnom infiltracijom kao kod lymphogranuloma venereum, bolesnika s ventralnom zakrivljenošću bilo kojeg uzroka i bolesnika s izoliranim deformitetom penisa u obliku pješčanog sata liječenje Xiapexom nije ispitivano i liječenje takvih bolesnika treba izbjegavati.
Powder: Contains sucrose, trometamol, hydrochloric acid Solvent: Contains calcium chloride dihydrate, sodium chloride, water for injection
Prašak: sadrži saharozu, trometamol, kloridnu kiselinu Otapalo: sadrži kalcijev klorid dihidrat, natrijev klorid, vodu za injekcije
No more than 3 attempts per affected joint are recommended to disrupt a cord.
Ne preporučuje se više od 3 pokušaja po zahvaćenom zglobu za raskidanje tračka.
You should gently stretch your penis 3 times a day for 6 weeks after each treatment cycle.
Trebate nježno istezati penis 3 puta dnevno tijekom 6 tjedana nakon svakog ciklusa liječenja.
There is no relevant use of Xiapex in the paediatric population aged 0-18 years for the treatment of Dupuytren's contracture.
Nema relevantne primjene Xiapexa u pedijatrijskoj populaciji u dobi od 0 do 18 godina za liječenje Dupuytrenove kontrakture.
The volume of solvent required and the volume of reconstituted Xiapex to be administered into the Dupuytren's cord differs depending on the type of joint being treated (for the reconstitution instructions, see section 6.6, Table 14).
Volumen potrebnog otapala i volumen rekonstituiranog Xiapexa koji će se primijeniti u Dupuytrenov tračak ovisi o vrsti zgloba koji se liječi (za upute o rekonstituciji vidjeti dio 6.6, tablicu 14).
A study AUX-CC-862 was conducted in patients with Dupuytren's contracture who had recurrence of contracture in a joint that was effectively treated with Xiapex in a previous clinical study.
Ispitivanje AUX-CC-862 provedeno je u bolesnika s Dupuytrenovom kontrakturom u kojih je došlo do recidiva kontrakture u zglobu koji je bio uspješno liječen Xiapexom u prethodnom kliničkom ispitivanju.
Xiapex must be reconstituted with the solvent provided and to the appropriate volume prior to intralesional injection (see section 6.6).
Xiapex se prije intralezijske injekcije mora rekonstituirati priloženim otapalom i do odgovarajućeg volumena (vidjeti dio 6.6).
In the two Phase 3 double-blind placebo-controlled studies, most adverse reactions were local events of the penis and groin and the majority of these events were of mild or moderate severity, and most (79%) resolved within 14 days of the injection.
U ta dva dvostruko slijepa, placebom kontrolirana ispitivanja faze 3, većina nuspojava bile su lokalne pojave u području penisa i prepona, većinom su bile blage ili umjerene težine i većina (79%) ih se povukla unutar 14 dana od injekcije.
Patients develop ADAs after repeated administration, the cross-reactivity of which versus endogenous MMPs involved in pregnancy and labour cannot be excluded.
Bolesnici nakon ponovne primjene razvijaju protutijela na lijek, čija se ukrižena reaktivnost s endogenim matriksnim metaloproteinazama uključenima u trudnoću i porođaj ne može isključiti.
When injecting a cord affecting a PIP joint of the fifth finger, the needle insertion must not be more than 2 to 3 mm in depth and not more than 4 mm distal to the palmar digital crease.
Kad se injicira u tračak koji zahvaća PIP zglob petog prsta ruke, igla se ne smije uvesti više od 2 do 3 mm u dubinu i ne više od 4 mm distalno od brazde korijena prsta.