natgillin/translations-raw huggingface dataset:
Xiapex is indicated for: 
Zdravilo Xiapex je indicirano za:
• avoidance of sex 
• izogibanje spolnosti
At study entry, patients must have had penile curvature deformity of at least 30 degrees in the stable phase of Peyronie's disease. 
Ob vstopu v študijo so morali imeti bolniki deformacijo ukrivljenosti penisa vsaj 30 stopinj v stabilni fazi Peyroniejeve bolezni.
All p-values < 0.001 for all comparisons between Xiapex and placebo, except for PIP joints in Study CORD II which was not eligible for statistical testing due to a hierarchical testing procedure. 
Vse p-vrednosti < 0,001 za vse primerjave med zdravilom Xiapex in placebom, razen za sklepe PIP v študiji CORD II, ki zaradi hierarhičnega testnega postopka ni bil primeren za statistično testiranje.
Animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, or embryonal/foetal development, (see section 5.3). 
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na plodnost, nosečnost ali razvoj zarodka/plodu (glejte poglavje 5.3).
Penile modelling procedure 
Postopek modeliranja penisa
Neutralizing antibodies were assayed for a subset of 70 samples selected to be representative of high and low titer binding antibody responses at week 12 of treatment. 
Nevtralizirajoča protitelesa so bila testirana pri podskupini 70 vzorcev, izbranih kot reprezentativnih za visok in nizek titer odgovora vezavnih protiteles v 12. tednu zdravljenja.
The clinical efficacy in study AUX-CC-862 was similar to that reported in studies CORD I and CORD II. 
Klinična učinkovitost v študiji AUX-CC-862 je bila podobna tisti, o kateri so poročali v študijah CORD I in CORD II.
If the curvature deformity is less than 15 degrees after the first, second or third treatment cycle, or if the physician determines that further treatment is not clinically indicated, then the subsequent treatment cycles should not be administered. 
Če je deformacija ukrivljenosti po prvem, drugem ali tretjem ciklu zdravljenja manjša od 15 stopinj ali če zdravnik določi, da nadaljnje zdravljenje ni klinično indicirano, se naknadnih ciklov zdravljenja ne sme izvršiti.
This is a disease that causes your finger(s) to bend inward. 
To je bolezen, ki povzroči upogib vašega prsta (vaših prstov) navznoter v dlan.
• The treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy (see sections 4.2 and 4.4). 
• zdravljenje odraslih moških s Peyroniejevo boleznijo z otipljivim plakom in deformacijo ukrivljenosti na začetku zdravljenja vsaj 30 stopinj (glejte poglavji 4.2 in 4.4).
After confirming that the needle is correctly placed in the cord, inject approximately one-third of the dose. 
Potem, ko ste preverili, da je igla pravilno nameščena v vozliču, injicirajte približno eno tretjino odmerka.
• Xiapex is given as part of a treatment cycle. 
• Zdravilo Xiapex se daje kot del cikla zdravljenja.
Retreatment of recurrent contractures 
Ponovno zdravljenje ponovljenih kontraktur
Early diagnosis and prompt evaluation and treatment are important because tendon rupture/ligament injury may potentially affect overall hand function. 
Zgodnja diagnoza in hitra ocenitev ter zdravljenje so pomembni, saj lahko ruptura kite/poškodba ligamenta vpliva na splošno funkcijo roke.
The goal is always to deposit the full dose entirely within the plaque. 
Cilj je vedno vnos celotnega odmereka znotraj plaka.
Peyronie's disease occurs exclusively in adult male patients and hence there is no relevant information for use in females. 
Peyroniejeva bolezen se pojavlja samo pri odraslih moških bolnikih, zato za uporabo pri ženskah ni relevantnih podatkov.
Your doctor must not use Xiapex if the reconstituted solution is discoloured or contains particles. 
Vaš zdravnik ne sme uporabiti zdravila Xiapex, če je rekonstituirana raztopina obarvana ali vsebuje delce.
The signs and symptoms of Peyronie's disease are caused by a collagen plaque. 
Znaki in simptomi Peyroniejeve bolezni so posledica kolagenskega plaka.
Collagenases are proteinases that hydrolyze collagen under physiological conditions. 
Kolagenaze so proteinaze, ki hidrolizirajo kolagen v fizioloških pogojih.
Other minor influences on the ability to drive and use machines include dizziness, paresthesia, hypoesthesia, and headache that have also been reported following injection of Xiapex. 
Drugi manjši vplivi na sposobnost vožnje in upravljanja strojev vključujejo omotico, parestezijo, hipestezijo in glavobol, ki so jih prav tako opisovali po injekciji zdravila Xiapex.
The maximal individual plasma concentrations of AUX-I and AUX-II were <29 ng/mL and <71 ng/mL, respectively. 
Največji posamični koncentraciji AUX-I oz. AUX-II v plazmi sta bili < 29 ng/ml oz. < 71 ng/ml.
Treatment of two concurrent injections 
Zdravljenje z dvema sočasnima injekcijama
This is called a corporal rupture or penile fracture. 
Temu se reče ruptura korpusa ali zlom penisa.
The median age of the patients included was 60, ranging between 33 and 77 years. 
Mediana starost vključenih bolnikov je bila 60 let, z razponom med 33 in 77 leti.
j) The second injection of each treatment cycle should be made approximately 2 to 3 mm apart from the first injection. 
j) Drugo injekcijo vsakega cikla zdravljenja je treba aplicirati približno 2 do 3 mm proč od prve injekcije.
The majority of the skin lacerations occurred on the manipulation day. 
Večina raztrganin kože se je pojavila na dan obravnave.
Time of finger extension after injection had no impact on the rate of clinical success for either MP or PIP joints. 
Čas iztegovanja prsta po injiciranju ni vplival na stopnjo kliničnega uspeha za MP ali PIP sklepe.
In addition, seropositivity for neutralizing anti-AUX-I and anti-AUX-II antibodies was maintained. 
Poleg tega je bila ohranjena seropozitivnost za nevtralizirajoča protitelesa proti AUX-I in proti AUX-II.
• increased white blood cells 
• povečano število belih krvnih celic
The safety of more than one treatment course of Xiapex for Peyronie's disease is not known. 
Varnost več kot enega postopka zdravljenja z zdravilom Xiapex za Peyroniejevo bolezen ni znana.
Use in patients with coagulation disorders 
Uporaba pri bolnikih z motnjami koagulacije
In patients treated for these two indications, there was no apparent correlation of antibody frequency, antibody titers, or neutralizing status to clinical response or adverse reactions. 
Pri bolnikih, zdravljenih za ti dve indikaciji, ni bilo očitne povezave med pogostnostjo protiteles, titrov protiteles ali nevtralizirajočega statusa in kliničnim odzivom ali neželenimi učinki.
Xiapex must be used with caution in patients with coagulation disorders or those taking anticoagulants. 
Zdravilo Xiapex je treba pri bolnikih z motnjami koagulacije ali pri tistih, ki jemljejo antikoagulante, uporabljati previdno.
Your doctor will take care of storing, handling and disposing of Xiapex. 
Zdravnik bo poskrbel za shranjevanje, pripravo in odstranjevanje zdravila Xiapex.
The two polypeptides are purified by chromatographic steps customary for the separation and isolation of biotherapeutic proteins to yield a consistent, well characterized and controlled mixture of two collagenase enzymes. 
Oba polipeptida sta očiščena s kromatografskimi koraki, ki so običajni za separacijo in izolacijo bioterapevtskih beljakovin, da nastane konsistentna, jasno opredeljena in nadzorovana mešanica dveh encimov kolagenaz.
• Recognition and treatment of severe immune-mediated reaction, including anaphylaxis. 
• prepoznava in zdravljenje hudih imunsko pogojenih reakcij, vključno z anafilaksijo,
• painful erection, painful sex and erectile dysfunction. 
• boleča erekcija, boleč spolni odnos in erektilna disfunkcija
N (%) of Joints in Each Intervala 
N (%) sklepov za vsak intervala
The median age was 58 years (range 23 to 84 years). 
Mediana starost je bila 58 let (razpon od 23 do 84 let).
The plaque may interfere with the ability to get a straight erection because the plaque will not stretch as much as the rest of the penis. 
Plak lahko vpliva na sposobnost ravne erekcije, saj se ne raztegne toliko kot preostanek penisa.
If more than one plaque is present, only the plaque causing the curvature deformity should be injected. 
Če je prisoten več kot en plak, je treba injicirati samo v plak, ki povzroča ukrivljenost.
Before finger manipulation procedure will be performed tell your doctor, if you have a condition affecting your bones, e.g. osteopenia or osteoporosis. 
Pred izvedbo postopka obravnave prsta povejte zdravniku, če imate bolezen, ki vpliva na kosti, npr. osteopenijo ali osteoporozo.
The finger extension procedures were performed approximately 24 to 72 hours after injection. 
Postopke iztegovanja prstov so opravili približno 24 do 72 ur po injiciranju.
All patients had participated in and completed the studies AUX-CC-803 or AUX-CC-804, in which they had received placebo. 
Vsi bolniki so prej sodelovali v študiji AUX-CC-803 ali AUX-CC-804, v kateri so prejemali placebo, in jo zaključili.
If you receive more Xiapex than you should 
Če ste dobili večji odmerek zdravila Xiapex, kot bi smeli
The injection procedure is detailed in the package leaflet and the physician training material and must be followed. 
Postopek injiciranja je podrobno opisan v navodilu za uporabo in gradivu za usposabljanje zdravnika in ga je treba upoštevati.
Patients should be instructed to comply with the treatment instructions (see section 4.2) and to promptly contact the physician if there is trouble bending the finger after the swelling goes down (symptoms of tendon rupture). 
Bolnikom je treba naročiti, naj upoštevajo navodila za zdravljenje (glejte poglavje 4.2) in se takoj obrnejo na svojega zdravnika, če bodo imeli težave pri pregibanju prstov potem, ko bo oteklina splahnela (simptomi rupture kite).
Severe injury like e.g. finger necrosis or fracture could result in loss of finger or finger parts. 
Huda poškodba, npr. nekroza ali zlom prsta, lahko povzroči izgubo prsta ali delov prsta.
The potential for a serious allergic reaction or the development of a musculoskeletal syndrome upon repeated use of Xiapex cannot be excluded. 
Možnosti za resno alergijsko reakcijo ali za razvoj mišično-skeletnega sindroma po ponovni uporabi zdravila Xiapex ni mogoče izključiti.
Data on the long-term recurrence rates following successful treatment with Xiapex are provided in Table 7. 
Podatki o dolgoročnem deležu ponovitve po uspešnem zdravljenju z zdravilom XIAPEX so na voljo v preglednici 7.
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. 
Za en dan boste morali omejiti gibanje zdravljenega prsta, neredko se pri nekaterih bolnikih prst iztegne sam od sebe.
Men with Peyronie's disease may have an erection that is curved or bent. 
Moški s Peyroniejevo boleznijo imajo lahko erekcijo, ki je ukrivljena ali upognjena.
• painful/increased urination 
• boleče/pogostejše uriniranje
There were no adverse reactions on early embryonic development (indicating no evidence of teratogenicity) in rats. 
Neželenih učinkov na zgodnji embrionalni razvoj pri podganah (kar kaže na to, da ni dokaza teratogenosti) ni bilo.
What Xiapex is and what it is used for What you need to know before you are given Xiapex How Xiapex is used 
Kaj je zdravilo Xiapex in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Xiapex Kako se uporablja zdravilo Xiapex
1 Not used to calculate physician rating of severity at baseline percentage-actual denominator of N=247 used. 
1 Ni bilo uporabljeno za izračun zdravnikove ocene stopnje resnosti ob izhodišču uporabljen je bil dejanski imenovalec n = 247.
Each injection was separated by approximately 4 weeks. 
Med posameznimi injekcijami je bil interval približno 4 tedne.
• blood sugar increased 
• povečanje krvnega sladkorja
a A joint was considered in an interval if the duration of assessment falls in the interval. 
a Sklep je bil v intervalu zajet, če je trajanje ocene sodilo v ta interval.
Pharmacotherapeutic group: Other Drugs For Disorders of the Musculo-Skeletal System-Enzymes, ATC code: M09AB02 
Farmakoterapevtska skupina: druga zdravila za zdravljenje motenj mišično-skeletnega sistemaencimi; oznaka ATC: M09AB02
An improvement from baseline was also seen in range of motion at Day 31 for all the treated joint pair subgroups, see Table 6. 
Izboljšanje od izhodišča so opazili tudi v razponu gibanja na 31. dan za vse podskupine zdravljenih parov sklepov, glejte preglednico 6.
Incorrect injection into tendons, nerves or blood vessels may result in bleeding or damage and possible permanent injury to these structures. 
Nepravilno injiciranje v kite, živce ali krvne žile lahko povzroči krvavitev ali poškodbo in možno trajno okvaro teh struktur.
Xiapex has not been studied in children and adolescents aged 0-18 years and hence no pharmacokinetic data are available. 
Zdravilo Xiapex ni bilo preskušano pri otrocih in mladostnikih, starih 0-18 let, in zato farmakokinetični podatki niso na voljo.
Peyronie's plaque 
Peyroniejev plak
• penis size reduced 
• zmanjšana velikost penisa
Wrap the patient's treated hand with a soft, bulky, gauze dressing. 
Povijte bolnikovo zdravljeno roko z mehko, obsežno obvezo iz gaze.
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. 
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.
After reconstitution, immediate use is recommended. 
Po rekonstituciji je priporočljiva takojšnja uporaba.
Since the enzymes in Xiapex have some sequence homology with human matrix metalloproteinases (MMPs), anti-drug antibodies (ADA) could theoretically interfere with human MMPs. 
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.
Your doctor will tell you when to remove the dressing. 
Zdravnik vam bo povedal, kdaj si obvezo odstranite.
For patients with an increased risk of fracture, e.g. patients with osteopenia/osteoporosis, special caution is needed during the manipulation procedure. 
Pri bolnikih s povečanim tveganjem za zlom, npr. pri bolnikih z osteopenijo/osteoporozo, je potrebna posebna previdnost med postopkom obravnave.
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. 
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.
Injection procedure a) The reconstituted Xiapex solution should be clear. 
Postopek injiciranja a) Rekonstituirana raztopina zdravila Xiapex mora biti bistra.
Patients with penile curvature >90° were not included in the clinical studies. 
> 90 ° v klinične študije niso bili vključeni.
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. 
Cikel zdravljenja je bil ponovljen v približno šesttedenskih intervalih do še trikrat, s skupaj največ 8 postopki injiciranja in skupaj 4 postopki modeliranja.
Each treatment cycle consists of two Xiapex injections and one penile modelling procedure. 
Vsak cikel zdravljenja sestavljata dve injekciji zdravila Xiapex in en postopek modeliranja penisa.
The total volume of the injection depends on the joint being treated. 
Celotni volumen injekcije je odvisen od sklepa, ki ga zdravimo.
A total of 189 patients were enrolled and treated with Xiapex. 
Vključenih je bilo skupaj 189 bolnikov, ki so bili zdravljeni z zdravilom Xiapex.
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). 
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.
• increased/decreased sensitivity to stimuli to senses 
• povečana/zmanjšana občutljivost na dražljaje za čutila
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. 
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.
A higher incidence of skin laceration may be attributable to more vigorous finger extension procedures in patients after receiving anaesthesia to the hand. 
Večjo incidenco raztrganja kože je mogoče pripisati bolj močnim postopkom iztegovanja prsta pri bolnikih, ki so prejeli anestezijo v roko.
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). 
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).
With your non-dominant hand, secure the patient's hand to be treated while simultaneously applying tension to the cord. 
S svojo nedominantno roko primite bolnikovo roko, ki jo boste zdravili, hkrati pa napnite vozlič.
Routine supportive care and symptomatic treatment must be provided in the case of overdose. 
V primerih prevelikega odmerjanja je potrebno zagotoviti rutinsko podporno in simptomatsko zdravljenje.
Patients develop ADAs after repeated administration, the cross-reactivity of which versus endogenous MMPs involved in pregnancy and labour cannot be excluded. 
Po večkratnih aplikacijah bolniki razvijejo protitelesa ADA, katerih križne reaktivnosti proti endogenim MMP, ki so vključeni v nosečnost in porod, ne moremo izključiti.
g) With the tip of the needle placed within the plaque, initiate injection, maintaining steady pressure to slowly inject the drug into the plaque. 
g) S konico igle v plaku začnite z injiciranjem in ohranjajte stalni pritisk za počasno injiciranje zdravila v plak.
• With one hand hold your penis. 
• Penis držite z eno roko.
Within each frequency group, adverse reactions are presented in order of decreasing seriousness. 
Znotraj vsake skupine pogostnosti so neželeni učinki navedeni po padajoči resnosti.
b p-value < 0.01 
b vrednost p < 0,01
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). 
Z vsakim prstom začnite s prizadetim sklepom na najbolj proksimalni strani prsta in nadaljujte proti distalni strani (npr. MP proti PIP).
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). 
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).
• 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). 
• če imate težave pri normalnem strjevanju krvi ali če jemljete kakršna koli zdravila, ki vplivajo na strjevanje krvi (antikoagulantna zdravila).
An open label phase 3 study, AUX-CC-806, evaluated the safety and efficacy of Xiapex. 
V odprti študiji 3. faze, AUX-CC-806, so ocenili varnost in učinkovitost zdravila Xiapex.
Proper needle position is tested and confirmed by carefully noting resistance to minimal depression of the syringe plunger. 
Pravilni položaj igle preverite in potrdite tako, da skrbno spremljate odpor na najmanjši pritisk na bat brizge.
Frequency of side effects not known 
Neznana pogostnost neželenih učinkov
This bending is called a contracture and is caused by the abnormal formation of a cord containing collagen under your skin. 
To upogibanje imenujemo kontraktura in ga povzroča nenormalna tvorba vozliča, ki vsebuje kolagen, pod vašo kožo.
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. 
Novih signalov o varnosti pri osebah, ki so jih spremljali 5 let po začetni injekciji zdravila Xiapex v predhodni klinični študiji, niso ugotovili.
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. 
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.
Different Fingers, Both MPs (n=244) 
Različna prsta, oba MP (n = 244)
Treatment of Peyronie's plaques that involve the penile urethra due to potential risk to this structure. 
Zdravljenje Peyroniejevih plakov, ki zajemajo sečnico penisa, zaradi potencialnega tveganja za to strukturo.
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. 
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.
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). 
V vsakem ciklu zdravljenja boste prejeli eno injekcijo zdravila Xiapex, ki ji bo sledila druga injekcija na drug dan (1 do 3 dni kasneje).
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. 
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.
• Not perform strenuous activity with the injected hand until advised to do so. 
• naj ne izvajajo napornih aktivnosti s svojo roko, dokler jim tega ne svetujete;
Each injection contains a 0.58 mg dose. 
Vsaka injekcija vsebuje odmerek 0,58 mg.
Post-treatment surgery The impact of treatment with Xiapex on subsequent surgery, if needed, is not known. 
Vpliv zdravljenja z zdravilom Xiapex na naknadno operacijo, če je potrebna, ni znan.