natgillin/translations-raw huggingface dataset:
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.
Budući da Xiapex nije supstrat citokroma P450 niti nekog drugog enzimskog puta kojim se metaboliziraju lijekovi i budući da se ne očekuju nikakvi aktivni metaboliti, nisu provedena ispitivanja metabolizma.
A popping noise or popping sensation in the penis, sometimes described as “snapping” or “cracking” and sometimes accompanied by detumescence, haematoma and/or pain, were reported in 73/551 (13.2%) Xiapex-treated patients and 1/281 (0.3%) placebo-treated patients, in Studies 1 and 2 combined.
Pucketajući zvuk ili osjećaj u penisu, ponekad opisan kao "škljocanje" ili "pucanje" i ponekad praćen detumescencijom, hematomom i/ili bolom, zabilježen je u 73/551 (13,2%) bolesnika liječenih Xiapexom i u 1/281 (0,3%) bolesnika liječenih placebom, u Ispitivanjima 1 i 2 zajedno.
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.
Jedina iznimka je uzimanje do 150 mg acetilsalicilne kiseline na dan (tvari koja je prisutna u mnogim lijekovima za sprječavanje zgrušavanja krvi), što je doza koja se smije uzimati.
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.
f) Uvedite iglu u plak i nastavite transverzalno kroz cijelu širinu plaka prema suprotnoj strani, ali nemojte potpuno proći kroz plak.
Direct pressure on the injection site should be avoided.
Treba izbjegavati izravan pritisak na mjesto injiciranja.
Each injection contains a 0.58 mg dose.
Svaka injekcija sadrži dozu od 0,58 mg.
Store in a refrigerator (2ºC-8ºC).
Čuvati u hladnjaku (2ºC-8ºC).
Serious adverse reactions of tendon rupture (6 cases), tendonitis (1 case), other ligament injury (2 cases) and complex regional pain syndrome (1 case) related to the medicinal product were reported.
Zabilježene su ozbiljne nuspojave u vezi s ovim lijekom, poput rupture tetive (6 slučajeva), tendinitisa (1 slučaj), drugih oštećenja ligamenta (2 slučaja) i kompleksnog regionalnog bolnog sindroma (1 slučaj).
If your finger is still not able to straighten during a follow-up visit with your doctor, you may need additional treatments with Xiapex which may be administered approximately 4 weeks after the first treatment.
Ako se u vrijeme kontrolnog posjeta liječniku Vaš prst i dalje ne može ispraviti, možda će Vam trebati dodatno liječenje Xiapexom, koji se može primijeniti približno 4 tjedna nakon prvog liječenja.
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.
Ciklus liječenja ponavljao se u razmacima od 6 tjedana još najviše 3 puta, do najviše 8 postupaka injiciranja i ukupno 4 postupka modeliranja.
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.
Pritisak na penis treba zadržati tijekom 30 sekundi, a zatim opustiti tijekom perioda odmora od 30 sekundi prije ponavljanja tehnike modeliranja penisa do ukupno 3 pokušaja modeliranja, s 30 sekundi za svaki pokušaj.
Since the enzymes in Xiapex have some sequence homology with human matrix metalloproteinases (MMPs), anti-drug antibodies (ADA) could theoretically interfere with human MMPs.
Budući da enzimi u lijeku Xiapex imaju djelomično homologan slijed ljudskim matriksnim metaloproteinazama (MMP), protutijela na lijek teoretski mogu ometati ljudske MMP.
• The need to inform the patient about the signs and symptoms associated with the treatment and when to seek attention from the health care provider.
• Važnost upoznavanja bolesnika sa simptomima povezanima s liječenjem i simptomima zbog kojih treba potražiti savjet liječnika.
• tremor/shaking, increased sensitivity to stimuli
• tremor/drhtanje, pojačana osjetljivost na podražaje
You will be given Xiapex as an injection directly into the area that is causing your finger/penis to bend (intralesional injection).
Xiapex će Vam se davati kao injekcija izravno u područje koje uzrokuje savijanje Vašeg prsta/penisa (intralezijska injekcija).
Improvement of the total fixed flexion contracture was also observed irrespectively of the time of finger extension, 24, 48 or 72 hours after injection, with a mean improvement at Day 31 of 75.2% 74.8% and 72.4% respectively.
Također je bilo opaženo poboljšanje cjelokupne fiksne fleksijske kontrakture neovisno o tome je li se ekstenzija prsta provela 24 sata, 48 sati ili 72 sata nakon injekcije, uz srednju vrijednost poboljšanja 31. dana od 75,2%, 74,8% odnosno 72,4%.
Identification of treatment area a) Prior to each treatment cycle, identify the treatment area as follows:
Utvrđivanje područja liječenja a) Prije svakog ciklusa liječenja utvrdite područje liječenja na sljedeći način:
Only the supplied solvent must be used for reconstitution; it contains calcium which is required for the activity of Xiapex.
Za rekonstituciju se mora uporabiti samo priloženo otapalo; ono sadrži kalcij koji je potreban za djelovanje Xiapexa.
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.
Tijekom petogodišnjeg razdoblja praćenja (tablica 13) ispitanici su pokazali poboljšanje u zakrivljenosti penisa i tegobama prema PQD upitniku u usporedbi sa zadnjom opaženom vrijednošću u prethodnim ispitivanjima faze III.
Same Finger, 1 MP, 1 PIP (n=350)
Isti prst, 1 MP, 1 PIP (n=350)
For joints reported as recurring in a previous study, the day of recurrence was the first visit with a fixed flexion contracture measurement of 20° or greater following the report of recurrence.
Za zglobove za koje je zabilježen recidiv u prethodnom ispitivanju, kao dan recidiva uzet je dan prvog posjeta s fiksnom fleksijskom kontrakturom od 20° ili više nakon prijave recidiva.
Severe penile haematoma was also reported as an adverse reaction in 39 of 1044 patients (3.7%) in the controlled and uncontrolled clinical studies in Peyronie's disease.
Težak oblik hematoma penisa također je zabilježen kao nuspojava u 39 od 1044 bolesnika (3,7%) u kontroliranim i nekontroliranim kliničkim ispitivanjima u Peyronijevoj bolesti.
The median age of the patients included was 60, ranging between 33 and 77 years.
Medijan dobi uključenih bolesnika iznosio je 60 godina, u rasponu između 33 i 77 godina.
Alanine aminotransferase increased Aspartate aminotransferase increased Body temperature increased
Pretrage opipljiv limfni čvor povišena alanin aminotransferaza povišena aspartat aminotransferaza povišena tjelesna temperatura
Routine supportive care and symptomatic treatment must be provided in the case of overdose.
U slučaju predoziranja mora se osigurati rutinska potporna skrb i simptomatsko liječenje.
Anaphylactic reaction was reported in a patient previously treated with Xiapex (1 case).
Anafilaktička reakcija bila je zabilježena u jednog bolesnika prethodno liječenog Xiapexom (1 slučaj).
Avoid direct pressure on the injection site.
Izbjegavajte izravan pritisak na mjesto injiciranja.
No dose adjustment is necessary in any special patient groups e.g., Elderly, Renally or Hepatically Impaired, by Gender or Race.
Nije potrebna prilagodba doze ni u jedne posebne skupine bolesnika, npr., starijih ili onih s oštećenjem bubrega ili jetre ili prema spolu ili rasi.
Taking into account the PRAC Assessment Report on the PSUR(s) for collagenase clostridium histolyticum, the scientific conclusions of the CHMP are as follows:
Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za kolagenazu clostridium histolyticum, znanstveni zaključci CHMP-a su sljedeći:
Signs or symptoms that may reflect serious injury to the treated finger/hand after injection or manipulation should be promptly evaluated because surgical intervention may be required.
Znakove ili simptome koji mogu ukazivati na ozbiljnu ozljedu liječenog prsta/šake nakon injekcije ili manipulacije treba što prije procijeniti, jer može biti potrebna kirurška intervencija.
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.
Kolagenaza clostridium histolyticum nije bila mutagena u Salmonella typhimurium (Amesovom testu) i nije bila klastogena ni u in vivo mišjem mikronukleusnom testu, niti u in vitro testu aberacije kromosoma u ljudskim limfocitima.
4.6 Fertility, pregnancy and lactation
4.6 Plodnost, trudnoća i dojenje Trudnoća i plodnost
No systemic toxicity was observed in this study at any dose level.
Sistemska toksičnost u ovom ispitivanju nije bila opažena ni kod koje veličine doze.
This is a disease that causes your finger(s) to bend inward.
To je bolest zbog koje se Vaš(i) prst(i) savijaju prema unutra.
1 Not used to calculate physician rating of severity at baseline percentage-actual denominator of N=247 used.
1 Nije korišteno za izračunavanje postotka liječnički ocjenjene početne težine - stvarni nazivnik koji se koristio je N=247.
The site chosen for injection must be the area where the contracting cord is maximally separated from the underlying flexor tendons and where the skin is not intimately adhered to the cord.
Mjesto odabrano za injekciju mora biti područje u kojem je kontraktura maksimalno odvojena od tetiva fleksora ispod nje i u kojem koža ne prianja uz tračak.
• Locate the plaque at the point of maximum concavity (or focal point) in the bend of the penis
• Odredite položaj plaka u točki maksimalne udubljenosti (ili žarišnoj točki) na zakrivljenom dijelu penisa
The potential risk for humans on parturition and postnatal development is unknown.
Nije poznato postoji li rizik za porođaj i postnatalni razvoj u ljudi.
• worsening of Peyronie's disease
• pogoršanje Peyronijeve bolesti
0.25 ml †Note that injection volume for delivery of a 0.58 mg dose is less than the total volume of solvent used for reconstitution.
0,25 ml †Obratite pažnju na to da je volumen injekcije potreban za isporuku doze od 0,58 mg manji od ukupnog volumena otapala upotrijebljenog za rekonstituciju.
*A formulation of two collagenase enzymes co-expressed and harvested from anaerobic fermentation of a phenotypically selected strain of Clostridium histolyticum bacterium.
*Formulacija s dva enzima kolagenaze istovremeno izražena i prikupljena anaerobnom fermentacijom fenotipski odabranog soja bakterije Clostridium histolyticum.
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) Kada je vrh igle postavljen u plak, započnite s injiciranjem zadržavajući stalan pritisak kako biste polako injicirali lijek u plak.
Almost all patients had positive titers for anti-AUX-I antibodies (97.9%) and anti-AUX-II antibodies (97.5%) 60 days post two concurrent injections.
Gotovo su svi bolesnici imali pozitivan titar protutijela na AUX-I (97,9%) i na AUX-II (97,5%) 60 dana nakon dvije istovremene injekcije.
No patients had quantifiable plasma levels 15 minutes after modelling of plaque on Day 3 (i.e., 24 hours after Injection 2 on Day 2).
Nijedan bolesnik nije imao mjerljive razine u plazmi 15 minuta nakon modeliranja plaka 3. dana (tj. 24 sata nakon 2. injekcije 2. dana).
**Based on the 95% CI of the mean not including zero, the percent change from baseline was considered statistically significant.
**Na temelju 95% CI srednje vrijednosti ne uključujući nulu, postotak promjene od početne vrijednosti smatrao se statistički značajnim.
Hold the penis in this more straightened position for 30 seconds, then let go.
Zadržite penis u ispravljenom položaju 30 sekundi zatim ga pustite.
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.
Primarni ishod svakog ispitivanja bio je procijeniti udio bolesnika u kojih se postiglo smanjenje kontrakture odabranog primarnog zgloba (MP ili PIP) na 5° ili manje u odnosu na normalu, približno 4 tjedna nakon posljednje injekcije u taj zglob.
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 može onemogućiti pravilnu erekciju jer se ne rastegne kao ostatak penisa.
After the injection, your doctor will place a dressing on your hand.
Nakon injekcije, liječnik će Vam staviti povoj na šaku.
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).
Nije opaženo da je sigurnost smanjena zbog inhibicije endogenih MMP; konkretno, nisu opažene nuspojave koje bi ukazivale na razvoj ili pogoršanje autoimunih bolesti ili razvoj mišićno-koštanog sindroma.
Following extension of your finger, your doctor will fit you with a splint to wear at bedtime for up to 4 months.
Nakon što Vam ispravi prst, liječnik će Vam dati udlagu za šaku koju ćete nositi tijekom spavanja do 4 mjeseca.
• Not to flex or extend the fingers of the injected hand to reduce extravasation of Xiapex out of the cord until the finger extension procedure is completed.
• ne savijaju ili ispružaju prste injicirane šake kako bi se smanjilo istjecanje Xiapexa iz tračka dok postupak ekstenzije prsta nije dovršen.
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).
Na svakom prstu počnite od najproksimalnijeg zahvaćenog zgloba i nastavite prema distalnijim zglobovima (npr. od MP prema PIP).
In the controlled and uncontrolled clinical studies of Xiapex in Peyronie's disease corporal rupture and other serious penile injury were reported uncommonly (see section 4.4)
U kontroliranim i nekontroliranim kliničkim ispitivanjima Xiapexa u Peyronijevoj bolesti ruptura korpusa i druge ozbiljne ozljede penisa zabilježene su manje često (vidjeti dio 4.4).
After treatment with Xiapex, blood vessels in your penis may also break, causing blood to collect under the skin (which is called a haematoma).
Nakon liječenja Xiapexom u Vašem penisu također mogu puknuti krvne žile, zbog čega se pod kožom nakuplja krv (što se naziva hematom).
The volume of reconstituted Xiapex to be administered into the plaque is 0.25 ml (for reconstitution instructions, see section 6.6, Table 14).
Volumen rekonstituiranog Xiapexa koji treba primijeniti u plak je 0,25 ml (za upute o rekonstituciji, vidjeti dio 6.6, tablicu 14).
Early diagnosis and prompt evaluation and treatment are important because tendon rupture/ligament injury may potentially affect overall hand function.
Važna je rana dijagnoza, kao i brza procjena i liječenje, jer ruptura tetive/ozljeda ligamenta može utjecati na cjelokupnu funkciju šake.
If the first finger extension procedure does not result in disruption of the cord, a second and third attempt can be performed at 5- to 10-minute intervals.
Ako prvi postupak ekstenzije prsta ne dovede do raskidanja tračka, može se pokušati drugi i treći put u razmacima od 5 do 10 minuta.
Orient the needle so that it enters the plaque from the side, NOT downwards or perpendicularly towards the corpora cavernosum.
Usmjerite iglu tako da uđe u plak sa strane, NE odozgo ili okomito prema kavernoznim tijelima.
Total (n=724)
Ukupno (n=724)
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.
Kolagenaze skupine I (α, β, γ i η) proizvodi su gena colG, započinju hidrolizu kolagena u blizini amino- i karboksi kraja domena trostrukog heliksa i stvaraju velike proteolitičke fragmente.
• Information on bleeding risk in patients with coagulation disorders including those on concurrent anti-coagulation therapy.
• Obavijesti o riziku od krvarenja u bolesnika s poremećajima koagulacije uključujući one koji istovremeno uzimaju antikoagulantnu terapiju.
• abnormal dreams
• nenormalni snovi
In addition, seropositivity for neutralizing anti-AUX-I and anti-AUX-II antibodies was maintained.
održana je seropozitivnost na neutralizirajuća protutijela na AUX-I i AUX-II.
Figure 4: Illustration how to straighten your penis
Slika 4: Ilustracija kako ispravljati penis
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.
Kod ovog stanja, u tkivu dlana ruke nastaje tračak i uzrokuje savijanje jednog ili više prstiju prema dlanu tako da se ne mogu ispružiti.
• agitation, disorientation, irritability, restlessness, difficulty sleeping
• uznemirenost, dezorijentacija, razdražljivost, nemir, poteškoće sa spavanjem
Treatment area
Područje za liječenje
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.
Budući da je proces razgradnje kolagena nakon primjene Xiapexa lokaliziran i ne zahtijeva niti izaziva mjerljive sistemske razine AUX-I i AUX-II, ne može se procijeniti primarna farmakodinamička aktivnost Xiapexa u ispitanika i stoga takva ispitivanja nisu niti pokrenuta.
Penile modelling helps relieve curvature deformity and straighten the penile shaft.
Modeliranje penisa pomaže smanjiti deformirajuću zakrivljenost i ispraviti tijelo penisa.
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.
Iako nema kliničkog dokaza interakcije tetraciklina, antraciklinskih/antrakinonskih antibiotika i derivata antrakinona sa Xiapexom, pokazalo se da takvi derivati inhibiraju razgradnju kolagena posredovanu matriksnim metaloproteinazama u farmakološki relevantnim koncentracijama in vitro.
Percentage of patients who achieved reduction in contracture to 5° or less (Last injection)
Tablica 4. Postotak bolesnika u kojih se postiglo smanjenje kontrakture na 5° ili manje (posljednja injekcija)
There was no evidence of accumulation following two sequential injections of Xiapex administered 24 hours apart.
Nije bilo dokaza o nakupljanju nakon dvije uzastopne injekcije Xiapexa primijenjene u razmaku od 24 sata.
Your doctor must not use Xiapex if the reconstituted solution is discoloured or contains particles.
Vaš liječnik ne smije primijeniti Xiapex ako je rekonstituirana otopina promijenila boju ili sadrži čestice.
Both classes of collagenases readily hydrolyze gelatin (denatured collagen) and small collagen peptides, whereas Class II has higher affinity for small collagen fragments.
Obje skupine kolagenaza brzo hidroliziraju želatinu (denaturirani kolagen) i male kolagenske peptide, s time da skupina II ima veći afinitet za male fragmente kolagena.
Swelling and pain may impair the use of the treated hand in Dupuytren's disease.
Otečenost i bol mogu narušiti uporabu liječene šake kod Dupuytrenove bolesti.
Open wound
• otvorena rana
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.
Poboljšanje deformirajuće zakrivljenosti bilo je numerički slično u bolesnika s početnom zakrivljenošću od 30 do 60 stupnjeva i u onih s deformirajućom zakrivljenošću od 61 do 90 stupnjeva.
This bending is called a contracture and is caused by the abnormal formation of a cord containing collagen under your skin.
To savijanje se zove kontraktura, a uzrokuje ju neprirodno stvaranje tračaka koji sadrže kolagen ispod kože.
Whilst there is no clinical evidence from the current safety data of a musculoskeletal syndrome developing following the administration of Xiapex, the potential for it to occur cannot be excluded.
Iako u podacima o sigurnosti trenutno nema kliničkih dokaza da se mišićno-koštani sindrom razvija nakon primjene lijeka Xiapex, ta se mogućnost ne može isključiti.
No new safety signals were identified during the 5 year follow-up period.
Tijekom tog petogodišnjeg razdoblja praćenja nisu utvrđeni nikakvi novi sigurnosni signali.
Tell your doctor if you have previously received or are thinking about receiving Xiapex to treat a condition known as Peyronie's disease.
Obavijestite svog liječnika ako ste prethodno primili ili razmišljate o primanju Xiapexa za liječenje stanja poznatog kao Peyronijeva bolest.
The recommended dose of your prescribed medicine is 0.58 mg.
Preporučena doza propisanog lijeka je 0,58 mg.
The diluent contains calcium which is required for the activity of Xiapex.
Otapalo sadrži kalcij koji je potreban za aktivnost Xiapexa.
The adverse reaction profile was similar after each injection, regardless of the number of injections administered.
Profil nuspojava bio je sličan nakon svake injekcije, bez obzira na broj primijenjenih injekcija.
Caution should be exercised when performing finger extension procedures in patients with bone fragility, which may predispose to digital phalangeal fracture (e.g. in patients with osteopenia/osteoporosis).
Potreban je oprez pri provođenju postupaka ekstenzije prsta u bolesnika s krhkim kostima, što može biti predispozicija za prijelom falangi prsta (npr. u bolesnika s osteopenijom/osteoporozom).
Proximal interphalangeal (PIP) joints: 0.7 mg.
Proksimalni interfalangealni (PIP) zglobovi: 0,7 mg.
Peyronie's disease: The treatment area should be identified and marked with a surgical marker on the erected penis.
Peyronijeva bolest: Potrebno je odrediti područje za liječenje i obilježiti ga kirurškim flomasterom na penisu u erekciji.
This is a condition where adult men have a ‘plaque' that can be felt and a curve to their penis.
To je stanje u kojem odrasli muškarci imaju "plak" koji se može napipati i koji savija njihov penis.
The majority of adverse events reported during the long-term follow-up period were non-serious, mild or moderate in intensity, and were not related to the local administration of Xiapex.
Većina štetnih događaja zabilježenih tijekom razdoblja dugoročnog praćenja nije bila ozbiljna, bila je blagog do umjerenog intenziteta te nije bila povezana s lokalnom primjenom Xiapexa.
The solution must be clear, colourless with no lumps or flakes or particles.
Otopina mora biti bistra, bezbojna, bez nakupina, pahuljica ili čestica.
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.
U bolesnika liječenih u ove dvije indikacije nije bilo nikakve očite korelacije između učestalosti razvoja protutijela, titra protutijela ili neutralizirajućeg statusa i kliničkog odgovora ili nuspojava.
Call your doctor right away if you have any of these symptoms of an allergic reaction after an injection of Xiapex:
Odmah nazovite svog liječnika ako nakon injekcije Xiapexa primijetite bilo koji od ovih simptoma alergijske reakcije:
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.
Nisu uočeni novi sigurnosni signali u ispitanika praćenih 5 godina nakon prve injekcije Xiapexa primljene u prethodnom kliničkom ispitivanju.