FrancophonIA/ELRC3.0 huggingface dataset:
English: Data on the long-term recurrence rates following successful treatment with Xiapex are provided in Table 7.
Slovenian: Podatki o dolgoročnem deležu ponovitve po uspešnem zdravljenju z zdravilom XIAPEX so na voljo v preglednici 7.
English: You must limit motion of the treated finger for a day and it is not uncommon for the finger to straighten on its own for some patients.
Slovenian: Za en dan boste morali omejiti gibanje zdravljenega prsta, neredko se pri nekaterih bolnikih prst iztegne sam od sebe.
English: Men with Peyronie's disease may have an erection that is curved or bent.
Slovenian: Moški s Peyroniejevo boleznijo imajo lahko erekcijo, ki je ukrivljena ali upognjena.
English: • painful/increased urination
Slovenian: • boleče/pogostejše uriniranje
English: There were no adverse reactions on early embryonic development (indicating no evidence of teratogenicity) in rats.
Slovenian: Neželenih učinkov na zgodnji embrionalni razvoj pri podganah (kar kaže na to, da ni dokaza teratogenosti) ni bilo.
English: What Xiapex is and what it is used for What you need to know before you are given Xiapex How Xiapex is used
Slovenian: Kaj je zdravilo Xiapex in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Xiapex Kako se uporablja zdravilo Xiapex
English: 1 Not used to calculate physician rating of severity at baseline percentage-actual denominator of N=247 used.
Slovenian: 1 Ni bilo uporabljeno za izračun zdravnikove ocene stopnje resnosti ob izhodišču uporabljen je bil dejanski imenovalec n = 247.
English: Each injection was separated by approximately 4 weeks.
Slovenian: Med posameznimi injekcijami je bil interval približno 4 tedne.
English: • blood sugar increased
Slovenian: • povečanje krvnega sladkorja
English: a A joint was considered in an interval if the duration of assessment falls in the interval.
Slovenian: a Sklep je bil v intervalu zajet, če je trajanje ocene sodilo v ta interval.
English: Pharmacotherapeutic group: Other Drugs For Disorders of the Musculo-Skeletal System-Enzymes, ATC code: M09AB02
Slovenian: Farmakoterapevtska skupina: druga zdravila za zdravljenje motenj mišično-skeletnega sistemaencimi; oznaka ATC: M09AB02
English: An improvement from baseline was also seen in range of motion at Day 31 for all the treated joint pair subgroups, see Table 6.
Slovenian: Izboljšanje od izhodišča so opazili tudi v razponu gibanja na 31. dan za vse podskupine zdravljenih parov sklepov, glejte preglednico 6.
English: Incorrect injection into tendons, nerves or blood vessels may result in bleeding or damage and possible permanent injury to these structures.
Slovenian: Nepravilno injiciranje v kite, živce ali krvne žile lahko povzroči krvavitev ali poškodbo in možno trajno okvaro teh struktur.
English: Xiapex has not been studied in children and adolescents aged 0-18 years and hence no pharmacokinetic data are available.
Slovenian: Zdravilo Xiapex ni bilo preskušano pri otrocih in mladostnikih, starih 0-18 let, in zato farmakokinetični podatki niso na voljo.
English: Peyronie's plaque
Slovenian: Peyroniejev plak
English: • penis size reduced
Slovenian: • zmanjšana velikost penisa
English: Wrap the patient's treated hand with a soft, bulky, gauze dressing.
Slovenian: Povijte bolnikovo zdravljeno roko z mehko, obsežno obvezo iz gaze.
English: In this condition, a cord forms in the tissue in the palm of the hand and causes one or more fingers to bend toward the palm so that they cannot be straightened.
Slovenian: V tem stanju v tkivu dlani roke nastane vozlič, ki povzroči ukrivljanje enega ali več prstov proti dlani, tako da se jih ne da iztegniti.
English: After reconstitution, immediate use is recommended.
Slovenian: Po rekonstituciji je priporočljiva takojšnja uporaba.
English: Since the enzymes in Xiapex have some sequence homology with human matrix metalloproteinases (MMPs), anti-drug antibodies (ADA) could theoretically interfere with human MMPs.
Slovenian: Ker imajo encimi v zdravilu XIAPEX nekatera zaporedja homologna s človeškimi matričnimi metaloproteinazami (MMP), bi lahko protitelesa proti zdravilu (ADA - anti-drug antibodies) teoretično vplivala na človeške MMP.
English: Your doctor will tell you when to remove the dressing.
Slovenian: Zdravnik vam bo povedal, kdaj si obvezo odstranite.
English: For patients with an increased risk of fracture, e.g. patients with osteopenia/osteoporosis, special caution is needed during the manipulation procedure.
Slovenian: Pri bolnikih s povečanim tveganjem za zlom, npr. pri bolnikih z osteopenijo/osteoporozo, je potrebna posebna previdnost med postopkom obravnave.
English: In other Xiapex-treated patients (9 of 1044; 0.9%), a combination of penile ecchymoses or haematoma, sudden penile detumescence, and/or a penile “popping” sound or sensation was reported, and in these cases, a diagnosis of corporal rupture cannot be excluded.
Slovenian: Pri drugih bolnikih, zdravljenih z zdravilom Xiapex (9 od 1.044; 0,9 %), so poročali o kombinaciji ekhimoz ali hematoma penisa, nenadni detumescenci penisa in/ali o "pokajočem" zvoku ali občutku v penisu, v teh primerih diagnoze rupture korpusa ni mogoče izključiti.
English: Injection procedure a) The reconstituted Xiapex solution should be clear.
Slovenian: Postopek injiciranja a) Rekonstituirana raztopina zdravila Xiapex mora biti bistra.
English: Patients with penile curvature >90° were not included in the clinical studies.
Slovenian: > 90 ° v klinične študije niso bili vključeni.
English: The treatment cycle was repeated at approximately six-week intervals for up to three additional times, for a maximum of 8 total injection procedures and 4 total modelling procedures.
Slovenian: Cikel zdravljenja je bil ponovljen v približno šesttedenskih intervalih do še trikrat, s skupaj največ 8 postopki injiciranja in skupaj 4 postopki modeliranja.
English: Each treatment cycle consists of two Xiapex injections and one penile modelling procedure.
Slovenian: Vsak cikel zdravljenja sestavljata dve injekciji zdravila Xiapex in en postopek modeliranja penisa.
English: The total volume of the injection depends on the joint being treated.
Slovenian: Celotni volumen injekcije je odvisen od sklepa, ki ga zdravimo.
English: A total of 189 patients were enrolled and treated with Xiapex.
Slovenian: Vključenih je bilo skupaj 189 bolnikov, ki so bili zdravljeni z zdravilom Xiapex.
English: In these studies, patients were given up to 4 treatment cycles of Xiapex or placebo (weeks 0, 6, 12, 18), and were followed in a non-treatment follow-up period (weeks 24-52).
Slovenian: V teh študijah so bolniki prejeli do 4 cikle zdravljenja z zdravilom Xiapex ali placebo (0., 6., 12., 18. teden), nato pa so jih spremljali v obdobju spremljanja brez zdravljenja (24.
English: • increased/decreased sensitivity to stimuli to senses
Slovenian: • povečana/zmanjšana občutljivost na dražljaje za čutila
English: One exception is the use of up to 150 mg daily dose of acetylsalicylic acid (a substance present in many medicines used to prevent blood clotting) which can be taken.
Slovenian: Edina izjema je dnevni odmerek do 150 mg acetilsalicilne kisline (učinkovina, ki je prisotna v številnih zdravilih, ki se jih uporablja za preprečevanje strjevanja krvi), ki jo lahko jemljete.
English: A higher incidence of skin laceration may be attributable to more vigorous finger extension procedures in patients after receiving anaesthesia to the hand.
Slovenian: Večjo incidenco raztrganja kože je mogoče pripisati bolj močnim postopkom iztegovanja prsta pri bolnikih, ki so prejeli anestezijo v roko.
English: No safety concerns related to the inhibition of endogenous MMPs have been observed, in particular no adverse events indicating the development or exacerbation of autoimmune diseases or the development of a musculoskeletal syndrome (MSS).
Slovenian: Varnostnih problemov v povezavi z inhibicijo endogenih MMP niso opazili, zlasti ne neželenih učinkov, ki bi nakazovali razvoj poslabšanja avtoimunskih bolezni ali razvoj mišično-skeletnih sindromov (MSS).
English: With your non-dominant hand, secure the patient's hand to be treated while simultaneously applying tension to the cord.
Slovenian: S svojo nedominantno roko primite bolnikovo roko, ki jo boste zdravili, hkrati pa napnite vozlič.
English: Routine supportive care and symptomatic treatment must be provided in the case of overdose.
Slovenian: V primerih prevelikega odmerjanja je potrebno zagotoviti rutinsko podporno in simptomatsko zdravljenje.
English: Patients develop ADAs after repeated administration, the cross-reactivity of which versus endogenous MMPs involved in pregnancy and labour cannot be excluded.
Slovenian: Po večkratnih aplikacijah bolniki razvijejo protitelesa ADA, katerih križne reaktivnosti proti endogenim MMP, ki so vključeni v nosečnost in porod, ne moremo izključiti.
English: g) With the tip of the needle placed within the plaque, initiate injection, maintaining steady pressure to slowly inject the drug into the plaque.
Slovenian: g) S konico igle v plaku začnite z injiciranjem in ohranjajte stalni pritisk za počasno injiciranje zdravila v plak.
English: • With one hand hold your penis.
Slovenian: • Penis držite z eno roko.
English: Within each frequency group, adverse reactions are presented in order of decreasing seriousness.
Slovenian: Znotraj vsake skupine pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: b p-value < 0.01
Slovenian: b vrednost p < 0,01
English: Within each finger, begin with the affected joint in the most proximal aspect of the finger and continue toward the distal aspect (eg, MP to PIP).
Slovenian: Z vsakim prstom začnite s prizadetim sklepom na najbolj proksimalni strani prsta in nadaljujte proti distalni strani (npr. MP proti PIP).
English: As an exploratory analysis, female sexual partners completed two questionnaires at both the screening visit and week 36: the PDQ for Female Sexual Partners (an adaptation of Peyronie's disease bother and psychological symptom domains of the PDQ for men, scoring from 0-12) and the Female Sexual Function Index (FSFI, scale from 2-36, where a higher score represents better sexual functioning).
Slovenian: Za eksploratorno analizo so ženske spolne partnerice izpolnile dva vprašalnika ob presejalnem obisku in obisku v 36. tednu: PDQ za ženske spolne partnerice (prilagojen vprašalnik domene težav in psiholoških simptomov zaradi Peyroniejeve bolezni (PDQ) za moške, z lestvico od 0-12) in indeksa ženske spolne funkcije (FSFI, Female Sexual Function Index, lestvica od 2-36, pri čemer je višji rezultat boljša spolna funkcija).
English: • if you have a history of problems with the normal clotting of your blood or if you are taking any medicines to help control the normal clotting of your blood (known as anticoagulation medicines).
Slovenian: • če imate težave pri normalnem strjevanju krvi ali če jemljete kakršna koli zdravila, ki vplivajo na strjevanje krvi (antikoagulantna zdravila).
English: An open label phase 3 study, AUX-CC-806, evaluated the safety and efficacy of Xiapex.
Slovenian: V odprti študiji 3. faze, AUX-CC-806, so ocenili varnost in učinkovitost zdravila Xiapex.
English: Proper needle position is tested and confirmed by carefully noting resistance to minimal depression of the syringe plunger.
Slovenian: Pravilni položaj igle preverite in potrdite tako, da skrbno spremljate odpor na najmanjši pritisk na bat brizge.
English: Frequency of side effects not known
Slovenian: Neznana pogostnost neželenih učinkov
English: This bending is called a contracture and is caused by the abnormal formation of a cord containing collagen under your skin.
Slovenian: To upogibanje imenujemo kontraktura in ga povzroča nenormalna tvorba vozliča, ki vsebuje kolagen, pod vašo kožo.
English: No new safety signals were identified among subjects who were followed for 5 years after their initial injection of Xiapex in a previous clinical study.
Slovenian: Novih signalov o varnosti pri osebah, ki so jih spremljali 5 let po začetni injekciji zdravila Xiapex v predhodni klinični študiji, niso ugotovili.
English: This includes medicines to help control the normal clotting of your blood (known as anticoagulation medicines), anthraquinone derivatives, some antibiotics (tetracyclines and anthracyclines/anthraquinolones) used to treat infections.
Slovenian: To vključuje zdravila, ki vplivajo na strjevanje krvi (poznamo jih tudi pod imenom antikoagulantna zdravila), derivate antrakinona, nekatere antibiotike (tetracikline in antracikline/antrakinolone) za zdravljenje okužb.
English: Different Fingers, Both MPs (n=244)
Slovenian: Različna prsta, oba MP (n = 244)
English: Treatment of Peyronie's plaques that involve the penile urethra due to potential risk to this structure.
Slovenian: Zdravljenje Peyroniejevih plakov, ki zajemajo sečnico penisa, zaradi potencialnega tveganja za to strukturo.
English: The penile pressure should be hold for 30 seconds, thereafter released with a resting period for 30 seconds before repeating the penile modelling technique for a total of 3 modelling attempts at 30 seconds for each attempt.
Slovenian: Pritisk na penis je treba vzdrževati 30 sekund, nato se ga sprosti in počaka 30 sekund, preden se tehnika modeliranja penisa ponovi, in sicer skupaj 3 poskusi s po 30 sekundami za vsak poskus.
English: In each treatment cycle, you will receive one injection of Xiapex, followed by a second injection on a separate day (1 to 3 days later).
Slovenian: V vsakem ciklu zdravljenja boste prejeli eno injekcijo zdravila Xiapex, ki ji bo sledila druga injekcija na drug dan (1 do 3 dni kasneje).
English: The MAH, in agreement with the competent authorities in the Member States, shall implement, prior to the launch, an educational programme for physicians aiming to ensure proper injection placement to minimize occurrence of injection-related adverse events and to inform on expected and potential risks associated with the treatment.
Slovenian: Imetnik dovoljenja za promet z zdravilom morapred prihodom zdravila na trg, po dogovoru s pristojnimi organi v državah članicah, zagotoviti izobraževalni program za zdravnike, ki je namenjen zagotavljanju izbire primernega mesta za injiciranje zdravila za zmanjševanje pojavnosti neželenih dogodkov, ki so povezani z injiciranjem, ter informiranju o pričakovanih in možnih tveganjih povezanih z zdravljenjem.
English: • Not perform strenuous activity with the injected hand until advised to do so.
Slovenian: • naj ne izvajajo napornih aktivnosti s svojo roko, dokler jim tega ne svetujete;
English: Each injection contains a 0.58 mg dose.
Slovenian: Vsaka injekcija vsebuje odmerek 0,58 mg.
English: Post-treatment surgery The impact of treatment with Xiapex on subsequent surgery, if needed, is not known.
Slovenian: Vpliv zdravljenja z zdravilom Xiapex na naknadno operacijo, če je potrebna, ni znan.
English: Both collagenases effectively cleave interstitial collagen but at different sites on the molecule; additionally, they prefer different conformations (triple helical versus denatured or cleaved).
Slovenian: Obe kolagenazi učinkovito cepita intersticijski kolagen, vendar na različnih mestih molekule; poleg tega pa imata afiniteto do različnih oblik (trojna spirala proti denaturirana ali cepljena).
English: For further information see “Instructions on how to gently stretch your penis” and “Instructions on how to gently straighten your penis” at the end of the Patient leaflet.
Slovenian: Za več informacij glejte »Navodila za nežno raztezanje penisa« in »Navodila za nežno ravnanje penisa« na koncu navodila za uporabo.
English: Orient the needle so that it enters the plaque from the side, NOT downwards or perpendicularly towards the corpora cavernosum.
Slovenian: Iglo usmerite tako, da v plak vstopi s strani, NE navzdol ali pravokotno na kavernozni telesi.
English: Your doctor may recommend you perform a series of finger flexion and extension exercises several times a day for several months.
Slovenian: Zdravnik vam utegne svetovati, da izvajajte serije vaj upogibanja in iztegovanja prstov večkrat dnevno več mesecev.
English: Because Xiapex is not a substrate for cytochrome P450 or other medicinal product metabolizing enzyme pathways, and because no active metabolites are expected, no metabolism studies have been performed.
Slovenian: Ker zdravilo Xiapex ni substrat za citokrom P450 ali druge encimske poti, ki presnavljajo zdravila, in ker ne pričakujemo aktivnih presnovkov, študije presnove niso bile izvedene.
English: The improvement in curvature deformity was numerically similar among patients with baseline deformity from 30 to 60 degrees and those with curvature deformity from 61 to 90 degrees.
Slovenian: Izboljšanje deformacije ukrivljenosti je bilo v številkah podobno med bolniki z izhodiščno deformacijo od 30 do 60 stopinj in tistimi z deformacijo ukrivljenosti od 61 do 90 stopinj.
English: There are no known interactions with concomitant use of medicines for erectile dysfunction and Xiapex treatment.
Slovenian: Ni znanih interakcij pri sočasni uporabi zdravil za erektilno disfunkcijo in zdravilom Xiapex.
English: The primary endpoint of each study was to evaluate the proportion of patients who achieved a reduction in contracture of the selected primary joint (MP or PIP) to 5° or less of normal, approximately 4 weeks after the last injection of that joint.
Slovenian: Primarni opazovani dogodek v vsaki študiji je bila ocena deleža bolnikov, ki so dosegli zmanjšanje kontrakture izbranega primarnega sklepa (MP ali PIP) na 5° ali manj od normale, približno 4 tedne po zadnjem injiciranju v ta sklep.
English: • After each injection of Xiapex, your penis may be wrapped with a bandage.
Slovenian: • Po vsaki injekciji zdravila Xiapex bodo morda vaš penis povili s povojem.
English: Administration of Xiapex at greater than recommended doses is expected to be associated with increased local reactions at the site of injection.
Slovenian: Pričakuje se, da je aplikacija zdravila Xiapex v odmerkih, ki so večji od priporočenih, povezana z povečanim številom lokalnih reakcij na mestu injiciranja.
English: • One to three days after the second injection of Xiapex in a treatment cycle, you will need to return to your doctor for a manual procedure that will help stretch and help straighten your penis.
Slovenian: • En do tri dni po drugi injekciji zdravila Xiapex v ciklu zdravljenja se boste morali vrniti k zdravniku za ročni postopek, ki bo pomagal pri raztezanju in ravnanju penisa.
English: With your other hand, gently bend your penis in the opposite direction of the curve (see Figure 4).
Slovenian: Z drugo roko nežno upognite penis v smeri nasproti ukrivljenosti (glejte sliko 4).
English: Class I collagenases (α, β, γ, and η) are the products of the colG gene, they initiate collagen hydrolysis near the amino and carboxy termini of triple helical domains and generate large proteolytic fragments.
Slovenian: Kolagenaze razreda I (α, β, γ, in η) so produkti gena colG in začnejo hidrolizo kolagena blizu amino in karboksi koncev trojne spirale ter proizvajajo velike proteolitične fragmente.
English: Mean Penile Curvature Deformity (degrees) (Min-Max)
Slovenian: Povprečna deformacija ukrivljenosti penisa (stopinje) (min-maks)
English: If you experience dizziness, numbness or altered sensation, and headache immediately after an injection of Xiapex you must avoid potentially hazardous tasks such as driving or using machines until these effects have passed or until advised by your doctor.
Slovenian: Če se takoj po takoj po injiciranju zdravila Xiapex pojavijo omotica, odrevenelost ali spremenjeno občutenje in glavobol, se morate izogibati morebitnim nevarnim opravilom, kot je na primer vožnja ali uporaba strojev, dokler ti učinki ne minejo ali dokler vam tega ne svetuje zdravnik.
English: Through the 5 year follow up period (Table 13), subjects demonstrated an improvement in penile curvature and in PDQ bother compared with the last observed value from the previous phase 3 studies.
Slovenian: V 5-letnem obdobju spremljanja (preglednica 13) se je pri osebah pokazalo izboljšanje glede ukrivljenosti penisa in težav zaradi PDQ v primerjavi z zadnjo opazovano vrednostjo iz prejšnjih študij 3. faze.
English: If a cord contracture remains, a passive finger extension procedure will be performed in an attempt to disrupt the cord.
Slovenian: Če je kontrakturni vozlič še prisoten, bo napravljen postopek pasivnega iztegovanja prstov, da bi poskušali prekiniti vozlič.
English: Your doctor will carefully select an area where the collagen cord is best accessible and will proceed with the injection into the cord.
Slovenian: Zdravnik bo skrbno izbral predel, kjer je kolagenski vozlič najlažje dostopen, in bo vanj injiciral zdravilo.
English: Tell your doctor right away if you have trouble stretching or straightening your penis, or if you have pain or other concerns.
Slovenian: Zdravniku takoj povejte, če imate težave z raztezanjem ali ravnanjem penisa ali bolečino oziroma druge skrbi.
English: 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.
Slovenian: Rezultat Področja težav je sestavljen iz naslednjih postavk, o katerih poročajo bolniki: skrb zaradi bolečine ob erekciji, izgled erekcije in vpliv Peyroniejeve bolezni na spolni odnos in pogostnost spolnega odnosa.
English: 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.
Slovenian: Če je treba med obiskom za zdravljenje zdraviti dva vozliča prizadetega sklepa istega roke, je treba za vsako rekonstitucijo in injekcijo uporabiti ločeni viali in injekcijski brizgi.
English: f) Insert and advance the needle transversely through the width of the plaque, towards the opposite side of the plaque without passing completely through it.
Slovenian: f) Iglo vstavite in potiskajte prečno skozi širino plaka, proti nasprotni strani plaka, a je ne potisnite do konca skozi plak.
English: Swelling and pain may impair the use of the treated hand in Dupuytren's disease.
Slovenian: Otekanje in bolečina lahko ovirata uporabo zdravljene roke pri Dupuytrenovi bolezni.
English: Same Finger, 1 MP, 1 PIP (n=350)
Slovenian: Isti prst, 1 MP, 1 PIP (n = 350)
English: The review of data presented in the PSUR for Xiapex, covering the period from 28 February 2018 to 27 February 2019, identified post-marketing and literature case reports of finger necrosis and/or amputation and of finger fractures in patients with Dupuytren's contracture treated with collagenase clostridium histolyticum.
Slovenian: Pri pregledu podatkov, predstavljenih v oceni PSUR za zdravilo Xiapex, ki pokriva obdobje od 28. februarja 2018 do 27. februarja 2019, so zaznali poročila o primerih iz obdobja trženja in literature o nekrozi prstov in/ali amputaciji in zlomih prstov pri bolnikih z Dupuytrenovo kontraktururo, zdravljenih s kolagenazo clostridium histolyticum.
English: Both classes of collagenases readily hydrolyze gelatin (denatured collagen) and small collagen peptides, whereas Class II has higher affinity for small collagen fragments.
Slovenian: Oba razreda kolagenaz z lahkoto hidrolizirata želatino (denaturiran kolagen) in majhne kolagenske peptide, medtem ko imajo kolagenaze razreda II večjo afiniteto za majhne kolagenske fragmente.
English: What you need to know before you are given Xiapex You must not be given Xiapex:
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Xiapex Zdravila Xiapex ne smete dobiti:
English: Collagenase clostridium histolyticum was not mutagenic in Salmonella typhimurium (AMES test) and was not clastogenic in both an in vivo mouse micronucleus assay and an in vitro chromosomal aberration assay in human lymphocytes.
Slovenian: Kolagenaza clostridium histolyticum ni bila mutagena v Salmonella typhimurium (Amesov test) in ni bila klastogena v in vivo mikrojedrnih preskušanjih pri miših ter v in vitro preskušanjih kromosomskih aberacij v človeških limfocitih.
English: After treatment with Xiapex, one of these tubes may break during an erection.
Slovenian: Po zdravljenju z zdravilom Xiapex se lahko katera od teh cevk med erekcijo zlomi.