FrancophonIA/ELRC3.0 huggingface dataset:
English: Both classes of collagenases readily hydrolyze gelatin (denatured collagen) and small collagen peptides, whereas Class II has higher affinity for small collagen fragments.
Croatian: Obje skupine kolagenaza brzo hidroliziraju želatinu (denaturirani kolagen) i male kolagenske peptide, s time da skupina II ima veći afinitet za male fragmente kolagena.
English: Swelling and pain may impair the use of the treated hand in Dupuytren's disease.
Croatian: Otečenost i bol mogu narušiti uporabu liječene šake kod Dupuytrenove bolesti.
English: Open wound
Croatian: • otvorena rana
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.
Croatian: 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.
English: This bending is called a contracture and is caused by the abnormal formation of a cord containing collagen under your skin.
Croatian: To savijanje se zove kontraktura, a uzrokuje ju neprirodno stvaranje tračaka koji sadrže kolagen ispod kože.
English: 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.
Croatian: 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.
English: No new safety signals were identified during the 5 year follow-up period.
Croatian: Tijekom tog petogodišnjeg razdoblja praćenja nisu utvrđeni nikakvi novi sigurnosni signali.
English: Tell your doctor if you have previously received or are thinking about receiving Xiapex to treat a condition known as Peyronie's disease.
Croatian: Obavijestite svog liječnika ako ste prethodno primili ili razmišljate o primanju Xiapexa za liječenje stanja poznatog kao Peyronijeva bolest.
English: The recommended dose of your prescribed medicine is 0.58 mg.
Croatian: Preporučena doza propisanog lijeka je 0,58 mg.
English: The diluent contains calcium which is required for the activity of Xiapex.
Croatian: Otapalo sadrži kalcij koji je potreban za aktivnost Xiapexa.
English: The adverse reaction profile was similar after each injection, regardless of the number of injections administered.
Croatian: Profil nuspojava bio je sličan nakon svake injekcije, bez obzira na broj primijenjenih injekcija.
English: 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).
Croatian: 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).
English: Proximal interphalangeal (PIP) joints: 0.7 mg.
Croatian: Proksimalni interfalangealni (PIP) zglobovi: 0,7 mg.
English: Peyronie's disease: The treatment area should be identified and marked with a surgical marker on the erected penis.
Croatian: Peyronijeva bolest: Potrebno je odrediti područje za liječenje i obilježiti ga kirurškim flomasterom na penisu u erekciji.
English: This is a condition where adult men have a ‘plaque' that can be felt and a curve to their penis.
Croatian: To je stanje u kojem odrasli muškarci imaju "plak" koji se može napipati i koji savija njihov penis.
English: 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.
Croatian: 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.
English: The solution must be clear, colourless with no lumps or flakes or particles.
Croatian: Otopina mora biti bistra, bezbojna, bez nakupina, pahuljica ili čestica.
English: 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.
Croatian: 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.
English: Call your doctor right away if you have any of these symptoms of an allergic reaction after an injection of Xiapex:
Croatian: Odmah nazovite svog liječnika ako nakon injekcije Xiapexa primijetite bilo koji od ovih simptoma alergijske reakcije:
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.
Croatian: Nisu uočeni novi sigurnosni signali u ispitanika praćenih 5 godina nakon prve injekcije Xiapexa primljene u prethodnom kliničkom ispitivanju.
English: • You should only gently straighten your penis if you have an erection that happens without any sexual activity (spontaneous erection).
Croatian: • Penis trebate nježno ispravljati samo kada imate erekciju koja se pojavila bez ikakve seksualne aktivnosti (spontana erekcija).
English: Figure 3: Illustration how to stretch your penis
Croatian: Slika 3: Ilustracija kako istezati penis
English: Different Fingers, Both PIPs (n=72)
Croatian: Različiti prsti, oba PIP (n=72)
English: These differences account for the ability of the two classes of enzymes to digest collagen in a complementary manner.
Croatian: Zbog ovih razlika te dvije skupine enzima razgrađuju kolagen na komplementarni način.
English: In contrast, the Class II collagenases (δ, ε, and ζ,) are products of colH gene, their initial cleavage sites are located within the interior of the collagen molecule and generate smaller collagen fragments.
Croatian: Za razliku od njih, kolagenaze klase II (δ, ε i ζ,) proizvodi su gena colH, mjesta s kojih započinju cijepanje smještena su u unutrašnjosti molekule kolagena i stvaraju manje kolagenske fragmente.
English: Be sure to ask your doctor when you can resume normal activities after treatment with Xiapex.
Croatian: Nemojte zaboraviti pitati liječnika kada smijete nastaviti s normalnim aktivnostima nakon liječenja
English: Sodium injected per plaque in the treatment of Peyronie's disease: 0.9 mg.
Croatian: Natrij ubrizgan po plaku kod liječenja Peyronijeve bolesti: 0,9 mg.
English: The cake of lyophilized powder should be intact and white in colour.
Croatian: Disk liofliliziranog praška treba biti intaktan i bijele boje.
English: AUX-I and AUX-II are single polypeptide chains consisting of approximately 1000 amino acids of known sequence with a molecular weight of 114 kDa and 113 kDa respectively as determined by mass spectrometry.
Croatian: AUX-I i AUX-II jednostruki su polipeptidni lanci koji se sastoje od približno 1000 aminokiselina poznatog slijeda i prema mjerenju masenom spektrometrijom, imaju molekularnu masu od 114 kDa odnosno 113 kDa.
English: The disease can cause a change in the shape of the erect penis due to the abnormal build-up of scar tissue, known as a plaque, within the stretchy fibres of the penis.
Croatian: Bolest može uzrokovati promjenu oblika penisa u erekciji zbog pretjeranog rasta ožiljkastog tkiva, koje se naziva plak, u rastezljivom tkivu penisa.
English: The mean (SD) FSFI score was 20.56 (10.08) at baseline and 26.72 (7.73) at week 36, a change from baseline of 7.54.
Croatian: FSFI-ju iznosila je 20,56 (10,08) na početku i 26,72 (7,73) u 36. tjednu, promjena od početne vrijednosti za 7,54.
English: Most patients experiencing tendon/ligament rupture or injury have gone on to have successful surgical repair.
Croatian: Većina bolesnika u kojih je nastala ruptura ili ozljeda tetive/ligamenta odlučila se na kirurški popravak, koji je bio uspješan.
English: For patients with an increased risk of fracture, e.g. patients with osteopenia/osteoporosis, special caution is needed during the manipulation procedure.
Croatian: U bolesnika s povećanim rizikom od prijeloma, tj. u bolesnika s osteopenijom/osteoporozom, potreban je poseban oprez tijekom postupka ekstenzije prsta.
English: Do not have sex or have any other sexual activity for at least 4 weeks after the second injection of a treatment cycle with Xiapex and after any pain and swelling has ceased and be cautious when resuming sexual activity.
Croatian: Nemojte imati spolne odnose ni bilo kakve druge seksualne aktivnosti najmanje 4 tjedna nakon druge injekcije u ciklusu liječenja Xiapexom te dok ne prestanu bol i oticanje, a potom budite pažljivi kod nastavka seksualne aktivnosti.
English: For Peyronie's disease, Xiapex breaks down the collagen in the plaque that is causing your erect penis to curve, which may help the previously bent erection to become straighter and enable you to feel less bothered by your disease.
Croatian: Kod Peyronijeve bolesti Xiapex razgrađuje kolagen u plaku koji uzrokuje zakrivljenost penisa u erekciji što može pomoći da prethodna zakrivljenost erekcije bude manja i omogućiti da osjećate manje tegoba zbog svoje bolesti.
English: Most adverse events were non-serious, mild or moderate in intensity, and related to the local administration of Xiapex or to the finger extension procedure to facilitate cord disruption.
Croatian: Većina nuspojava nije bila ozbiljna, bila je blagog do umjerenog intenziteta i povezana s lokalnom primjenom Xiapexa ili postupkom ekstenzije prsta kako bi se olakšalo raskidanje tračka.
English: The most frequently reported adverse drug reactions (≥25%) during the Xiapex controlled clinical studies were penile haematoma, penile swelling and penile pain.
Croatian: Najčešće zabilježene nuspojave (≥25%) tijekom kontroliranih kliničkih ispitivanja Xiapexa bile su hematom penisa, oticanje penisa i bol u penisu.
English: Peyronie's disease occurs exclusively in adult male patients and hence there is no relevant use of Xiapex in the paediatric population aged 0-18 years for the treatment of Peyronie's disease.
Croatian: Peyronijeva bolest nastaje isključivo kod odraslih muških bolesnika i zato nema odgovarajuće primjene Xiapexa u pedijatrijskoj populaciji u dobi od 0 do 18 godina za liječenje Peyronijeve bolesti.
English: For PIP joints do not inject more than 4 mm distal to the palmar digital crease.
Croatian: U PIP zglobove nemojte davati injekciju više od 4 mm distalno od palmarno-digitalne brazde.
English: The most frequently reported adverse reactions during the Xiapex clinical studies (272 of 409 patients received up to three single injections of Xiapex and 775 patients received two concurrent injections in the same hand) were local injection site reactions such as oedema peripheral (local to the injection site), contusion (including ecchymosis), injection site haemorrhage and injection site pain.
Croatian: Najčešće zabilježene nuspojave tijekom kliničkih ispitivanja Xiapexa (272 od 409 bolesnika primila su do tri jednokratne injekcije Xiapexa, a 775 bolesnika primilo je istovremeno dvije injekcije u istu šaku) bile su lokalne reakcije na mjestu injekcije, kao što su periferni edem (lokalno na mjestu injekcije), kontuzija (uključujući ekhimozu) te krvarenje i bol na mjestu injekcije.
English: The double-blind study population comprised 409 patients of whom 272 received Xiapex 0.58 mg and 137 received placebo.
Croatian: Populacija u dvostruko slijepim ispitivanjima sastojala se od 409 bolesnika od kojih je 272 primilo 0,58 mg Xiapexa, a 137 placebo.
English: • Induce a penile erection
Croatian: • Inducirajte erekciju penisa
English: In study AUX-CC-862, 64.5% of recurrent MP joints and 45.0% of recurrent PIP joints achieved clinical success after retreatment with up to three injections of Xiapex.
Croatian: U ispitivanju AUX-CC-862, u 64,5% MP zglobova s recidivom i 45,0% PIP zglobova s recidivom postignut je klinički uspjeh nakon ponovnog liječenja s najviše 3 injekcije Xiapexa.
English: Clinically meaningful improvement in hand function as determined by the URAM (Unite´ Rhumatologique des Affections de la Main) score was observed at Day 31 (-11.3) and Day 61 (-12.3).
Croatian: Rhumatologique des Affections de la Main) bilo je opaženo 31. (-11,3) i 61. dana (-12,3).
English: Proper needle position is tested and confirmed by carefully noting resistance to minimal depression of the syringe plunger.
Croatian: Pravilan položaj igle pažljivo ispitajte i potvrdite otporom koji se javlja na minimalni pritisak na klip štrcaljke.
English: The safety of more than one treatment course of Xiapex for Peyronie's disease is not known.
Croatian: Sigurnost više od jedne kure liječenja Xiapexom u liječenju Peyronijeve bolesti nije poznata.
English: Abnormal dreams Depression Sexual inhibition
Croatian: Psihijatrijski poremećaji nenormalni snovi depresija seksualna inhibicija
English: The potential for a serious allergic reaction or the development of a musculoskeletal syndrome upon repeated use of Xiapex cannot be excluded.
Croatian: Ne može se isključiti mogućnost pojave ozbiljne alergijske reakcije ili razvoja mišićno-koštanog sindroma nakon ponovne primjene Xiapexa.
English: The second Xiapex injection is administered 1 to 3 days after the first injection.
Croatian: Druga injekcija Xiapexa primjenjuje se 1-3 dana nakon prve injekcije.
English: Mean duration of PD (years) (Min-Max)
Croatian: Srednje trajanje PB (godine) (min-maks.)
English: On the basis of the scientific conclusions for collagenase clostridium histolyticum the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing collagenase clostridium histolyticum is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za kolagenazu clostridium histolyticum, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) kolagenazu clostridium histolyticum nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Solvent required for reconstitution
Croatian: Otapalo potrebno za rekonstituciju
English: Xiapex is comprised of a mixture of Class I (AUX-I) and Class II (AUX-II) clostridial collagenases in a defined mass ratio.
Croatian: Xiapex se sastoji od mješavine skupine I (AUX-I) i skupine II (AUX-II) klostridijskih kolagenaza u definiranom masenom omjeru.
English: Together, these collagenases work to provide broad hydrolytic activity towards collagen.
Croatian: Zajedno te kolagenaze djeluju tako da imaju širok raspon hidrolitičkog djelovanja na kolagen.
English: N=29 N=154 N=123 Mean±SD 6.5±3.47 3.4±3.30 3.2±3.30 2.7±2.84 2.5±3.01 2.4±2.89 Median 6.0 Min, Max 0, 15
Croatian: Srednja vrijednost±SD 6,5±3,47 3,4±3,30 3,2±3,30 2,7±2,84 2,5±3,01 2,4±2,89
English: With your non-dominant hand, secure the patient's hand to be treated while simultaneously applying tension to the cord.
Croatian: Nedominantnom rukom čvrsto uhvatite šaku bolesnika koju treba liječiti i istovremeno pritisnite tračak.
English: Your doctor will inject Xiapex into the plaque that is causing your penis to curve.
Croatian: Vaš će Vam liječnik ubrizgati Xiapex u plak koji uzrokuje zakrivljenost Vašeg penisa.
English: With the other hand, hold the base of your penis with the fingers (see Figure 3).
Croatian: Prstima druge ruke držite korijen penisa (pogledajte sliku 3).
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.
Croatian: • Jedan do tri dana nakon druge injekcije Xiapexa u ciklusu liječenja trebat ćete otići kod svog liječnika kako bi se proveo ručni postupak istezanja i izravnavanja Vašeg penisa.
English: Your doctor will tell you when to come back for this.
Croatian: Vaš liječnik će Vam reći kada da dođete obaviti postupak.
English: In a single-dose phase or 61-day repeat-dose phase (3 times a week every 3 weeks for 3 cycles) study of intrapenile administration of collagenase clostridium histolyticum in dogs at exposures lower than or equal to the maximum recommended human dose on a mg/m2 basis, there was no evidence of systemic toxicity.
Croatian: U ispitivanju jednokratne doze, kao i u ispitivanju ponovljenih doza tijekom 61 dana (3 puta tjedno svaka 3 tjedna kroz 3 ciklusa), primjena kolagenaze clostridium histolyticum u penis pasa pri izloženostima nižim ili jednakim maksimalnoj preporučenoj dozi u ljudi (temeljeno na mg/m2), nije bilo dokaza sistemske toksičnosti.
English: Physicians should advise the patient to wait for at least 4 weeks after the second injection of a treatment cycle before resuming sexual activity taking care to ensure that any pain and swelling has ceased and to be cautious when resuming sexual activity.
Croatian: Liječnici trebaju savjetovati bolesniku da pričeka najmanje 4 tjedna nakon druge injekcije u ciklusu liječenja prije nastavka seksualne aktivnosti, uz pretpostavku da su bol i oteklina dotad već prošle, a pri čemu trebaju biti oprezni kod nastavka seksualne aktivnosti.
English: When administering two injections in the same hand during a treatment visit, use a new syringe and separate vial of reconstituted solution (containing 0.58 mg of Xiapex) for the second injection.
Croatian: Kada prilikom terapijskog posjeta primjenjujete dvije injekcije u istu šaku, uporabite novu štrcaljku i zasebnu bočicu rekonstituirane otopine (koja sadrži 0,58 mg Xiapexa) za drugu injekciju.
English: The clinical efficacy in study AUX-CC-862 was similar to that reported in studies CORD I and CORD II.
Croatian: Klinička djelotvornost u ispitivanju AUX-CC-862 bila je slična onoj zabilježenoj u ispitivanjima CORD I i
English: Care should be taken when injecting Xiapex into cords contracting the PIP joints as clinical studies indicate an increased risk of tendon rupture and ligament injury associated with treatment of PIP contractures with Xiapex.
Croatian: Potreban je oprez kada se Xiapex injicira u tračke koji izazivaju kontrakturu PIP zglobova, jer klinička ispitivanja ukazuju na povećan rizik od rupture tetive i ozljede ligamenta povezano s liječenjem PIP kontraktura Xiapexom.
English: Xiapex is used for the treatment of two different conditions: Dupuytren's contracture in adult patients with a palpable cord and Peyronie's disease in adult men.
Croatian: Xiapex se primjenjuje za liječenje dva različita stanja: Dupuytrenove kontrakture u odraslih bolesnika s opipljivim tračkom i Peyronijeve bolesti u odraslih muškaraca.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE sight and REACH OF CHILDREN
Croatian: POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
English: If insertion of the needle into a tendon is suspected or paresthesia is noted by the patient, withdraw the needle and reposition it into the cord.
Croatian: Ako sumnjate da je igla uvedena u tetivu ili ako bolesnik osjeti paresteziju, izvucite iglu i ponovno je uvedite u tračak.
English: Therefore, the use of Xiapex is not recommended in pregnancy and treatment should be postponed until after pregnancy.
Croatian: Stoga se ne preporučuje primjena Xiapexa u trudnica i liječenje treba odgoditi do završetka trudnoće.
English: A penile modelling procedure is performed 1 to 3 days after the second injection of each treatment cycle.
Croatian: Postupak modeliranja penisa provodi se 1-3 dana nakon druge injekcije svakog ciklusa liječenja.
English: • inflammation of the lymph nodes (lymphadenitis), inflammation of lymphatic channels (lymphangitis) leading to reddened skin with elevated borders, tender and warm, usually accompanied by a red streak, enlarged lymph nodes
Croatian: • upala limfnih čvorova (limfadenitis), upala limfnih žila (limfangitis) od koje koža postaje crvena s uzdignutim rubovima, osjetljiva na dodir i topla, obično popraćena crvenom prugom, povećanjem limfnih čvorova
English: Apply antiseptic at the site of the injection and allow the skin to dry.
Croatian: Nanesite antiseptik na mjesto injiciranja i ostavite da se koža osuši.
English: At study entry, patients in the clinical studies had: (1) a finger flexion contracture with a palpable cord of at least one finger (other than the thumb) of 20° to 100° in a MP joint or 20° to 80° in PIP joint and (2) a positive “table top test” defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
Croatian: Na ulasku u ispitivanje, bolesnici u kliničkim ispitivanjima imali su: (1) fleksijsku kontrakturu prsta s opipljivim tračkom barem jednog prsta (osim palca) od 20° do 100° na metakarpofalangealnom (MP) zglobu ili od 20° do 80° na proksimalnom interfalangealnom (PIP) zglobu i (2) pozitivan “test površine stola” definiran kao nemogućnost da zahvaćeni prst(i) budu priljubljeni uz površinu stola istovremeno s dlanom.
English: • increased/decreased sensitivity to stimuli to senses
Croatian: • povećana/smanjena osjetljivost osjetila na podražaje
English: In the retreatment study AUX-CC-862, 150 anti-AUX-I antibody positive samples and 149 anti-AUX-II antibody positive samples were assessed for potential cross-reactivity with human MMPs-1, -2, -3, -8, and -13.
Croatian: U AUX-CC-862 ispitivanju ponovnog liječenja procijenjena je moguća križna reaktivnost 150 uzoraka pozitivnih na anti-AUX-I protutijela i 149 uzoraka pozitivnih na anti-AUX-II protutijela s ljudskim MMP 1, 2, 3, 8 i 13.
English: The following side effects have been seen with Xiapex:
Croatian: Opažene su sljedeće nuspojave Xiapexa:
English: Pre-existing reduced peripheral circulation, e.g. Raynaud syndrome, and the use of epinephrine combined with local anaesthetics in these patients may contribute to this (see also section 4.8).
Croatian: U tih je bolesnika tome mogla pridonijeti već prisutna oslabljena periferna cirkulacija (npr. Raynaudov sindrom) te primjena adrenalina u kombinaciji s lokalnim anesteticima (vidjeti i dio 4.8).
English: If you are treated for Dupuytren's contracture
Croatian: Ako se liječite zbog Dupuytrenove kontrakture
English: Mean Penile Curvature Deformity (degrees) (Min-Max)
Croatian: Srednja deformirajuća zakrivljenost penisa (stupnjevi) (min-maks.)
English: Instructions for use and handling
Croatian: Upute za primjenu i rukovanje
English: The solvent that is used to dissolve the powder is a clear colourless liquid.
Croatian: Otapalo koje se upotrebljava za otapanje praška je bistra, bezbojna tekućina.
English: Low levels of Xiapex were quantifiable in the plasma of evaluable male patients for up to 30 minutes following administration of Xiapex into the penile plaque of patients with Peyronie's disease (see section 5.2).
Croatian: Niske razine Xiapexa bile su mjerljive u plazmi muških bolesnika do 30 minuta nakon primjene Xiapexa u plak penisa u bolesnika s Peyronijevom bolešću (vidjeti dio 5.2).
English: When administering two injections in the same hand during a treatment visit, begin with the affected finger in the most ulnar aspect of the hand and continue toward the radial aspect (eg, fifth finger to index finger).
Croatian: Kada prilikom terapijskog posjeta primjenjujete dvije injekcije u istu šaku, počnite od zahvaćenog prsta s ulnarne strane šake i nastavite prema radijalnoj strani (npr. od petog prsta prema kažiprstu).
English: With your dominant hand, place the needle into the cord, using caution to keep the needle within the cord.
Croatian: Dominantnom rukom uvedite iglu u tračak, pazeći pritom da iglu zadržite unutar tračka.
English: Xiapex may have a major influence on the ability to drive and use machines due to the swelling and pain which may impair the use of the treated hand in Dupuytren's disease.
Croatian: Xiapex može značajno utjecati na sposobnost upravljanja vozilima i rada sa strojevima zbog otečenosti i bola, koji mogu narušiti funkciju liječene šake kod Dupuytrenove bolesti.
English: • pain in your penis
Croatian: • bol u Vašem penisu
English: b) Apply antiseptic at the site of the injection and allow the skin to dry.
Croatian: b) Nanesite antiseptik na mjesto injiciranja i ostavite da se koža osuši.