FrancophonIA/ELRC3.0 huggingface dataset:
English: It is caused by a thickening of the tissues under the skin of the palm that form ‘cords' pulling down on the fingers.
Croatian: Uzrokovane su zadebljanjem tkiva ispod kože dlana koji tvori „niti“ koje vuku prste prema dolje.
English: Xiapex must not be used to treat Peyronie's disease if the plaque affects the urethra (the tube that carries urine and semen to the outside).
Croatian: Xiapex se ne smije koristiti za liječenje Peyronijeve bolesti ako plak utječe na mokraćnu cijev (cijev kojom mokraća i sjeme izlaze van).
English: Xiapex is a powder and solvent that are made up into a solution for injection.
Croatian: Xiapex je prašak i otapalo od kojih se radi otopina za injekciju.
English: A risk management plan has been developed to ensure that Xiapex is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Xiapex.
English: The main measures of effectiveness were the reduction in the abnormal curvature of the penis and the extent to which the condition was bothersome to the patient.
Croatian: Glavna mjera djelotvornosti bilo je smanjenje u abnormalnoj zakrivljenosti penisa i mjera u kojoj je stanje bilo neugodno za bolesnika.
English: Xiapex was also more effective than placebo in treating Peyronie's disease, producing a 38% and 31% improvement in abnormal curvature in the two studies, compared with 21% and 15% respectively for placebo.
Croatian: Xiapex je također bio djelotvorniji od placeba u liječenju Peyronijeve bolesti, s rezultatom od 38% i 31% poboljšanja abnormalne zakrivljenosti u dva ispitivanja, u usporedbi s 21% i 15% u skupini koja je primala placebo.
English: Other information about Xiapex
Croatian: Ostale informacije o lijeku Xiapex:
English: Peyronie's disease is a condition in which men develop plaques of fibrous, scar-like tissue in their penis, causing it to become abnormally curved, and sometimes leading to pain or difficulty in sexual intercourse.
Croatian: Peyronijeva bolest je stanje u kojem se u muškaraca razvijaju plakovi fibroze, tkiva sličnog ožiljcima u penisu, što uzrokuje abnormalnu zakrivljenost, a ponekad uzrokuje bol ili poteškoće tijekom spolnog odnosa.
English: Xiapex is used in patients with plaques that can be felt through the skin and in whom the abnormal curvature of the penis is at least 30 degrees at the start of therapy.
Croatian: Xiapex se koristi u bolesnika s plakovima koji se mogu osjetiti kroz kožu i u kojih abnormalna zakrivljenost penisa iznosi najmanje 30 stupnjeva na početku terapije.
English: The main measure of effectiveness was the proportion of patients whose main affected joint could be straightened so that it was bent forwards by no more than 5 degrees.
Croatian: Glavna mjera djelotvornosti bio je omjer bolesnika čiji se glavni zahvaćeni zglob mogao izravnati tako da se savijao prema naprijed za ne više od 5 stupnjeva.
English: Xiapex is to be used in patients with cords in their palms that are thick enough to be felt through the skin.
Croatian: Xiapex se koristi u bolesnika s nitima u dlanovima koje su dovoljno debele da se osjete kroz kožu.
English: A ‘penile modeling procedure' is then performed by the doctor after a further 1 to 3 days to gently stretch and bend the plaque in the opposite direction to the abnormal curvature.
Croatian: Zatim liječnik provodi "postupak modeliranja penisa" nakon daljnja 1 do 3 dana pažljivog istezanja i savijanja plaka u suprotnom smjeru od normalne zakrivljenosti.
English: For patients with Peyronie's disease, Xiapex is given for up to 4 treatment cycles each lasting about 6 weeks.
Croatian: U slučaju bolesnika s Peyronijevom bolešću, Xiapex se primjenjuje do maksimalno 4 terapijska ciklusa, pri čemu svaki ciklus traje otprilike 6 tjedana.
English: Patients received up to 4 treatment cycles, each involving two injections and subsequent modeling procedures, and the effects were measured on follow-up after 1 year.
Croatian: Bolesnici su primili do 4 terapijska ciklusa, pri čemu je svaki obuhvatio dvije injekcije i naknadni postupak modeliranja, a djelovanje je izmjereno prilikom kontrole nakon 1 godine.
English: For Dupuytren's contracture, the doctor injects the appropriate dose of Xiapex directly into a cord in the patient's palm.
Croatian: U slučaju Dupuytrenove kontrakture, liječnik ubrizgava odgovarajuću dozu lijeka Xiapex izravno u nit na dlanu bolesnika.
English: For Peyronie's disease, Xiapex was compared with placebo in two further studies involving 832 men.
Croatian: U slučaju Peyronijeve bolesti, Xiapex je uspoređen s placebom u dva daljnja ispitivanja koja su obuhvatila 832 muškarca.
English: The CHMP decided that Xiapex's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Xiapex nadmašuju s njim povezane rizike te je za njega preporučio izdavanje odobrenja za stavljanje u promet.
English: The collagenases in Xiapex are extracted from the bacterium Clostridium histolyticum.
Croatian: Kolagenaze u lijeku Xiapex ekstrahiraju se iz bakterije clostridium histolyticum.
English: Xiapex is used to treat Dupuytren's contracture and Peyronie's disease in adults.
Croatian: Xiapex se koristi za liječenje Dupuytrenove kontrakture i Peyronijeve bolesti u odraslih.
English: Xiapex was compared with placebo (a dummy treatment) in two main studies involving a total of 374 adult patients with Dupuytren's contracture.
Croatian: Xiapex je uspoređen s placebom (prividnim liječenjem) u dva glavna ispitivanja koja su obuhvatila 374 odrasla bolesnika s Dupuytrenovom kontrakturom.
English: In the second study the figures were 44% (20 out of 45) for the Xiapex group and 5% (1 out of 21) for the placebo group.
Croatian: U drugom ispitivanju te su vrijednosti bile 44% (u 20 od 45 osoba) u skupini koja je primala Xiapex te 5% (u 1 od 21 osobe) u skupini koja je primala placebo.
English: For more information about treatment with Xiapex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Xiapex pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: What is the risk associated with Xiapex?
Croatian: Koji su rizici povezani s lijekom Xiapex?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Xiapex, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku Xiapex nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: For more information on the use of Xiapex, including instructions on finger extension and penile modeling procedures, see the summary of product characteristics (also part of the EPAR).
Croatian: Za dodatne informacije o primjeni lijeka Xiapex, uključujući i upute o ekstenziji prsta i postupku modeliranja penisa, vidjeti sažetak opisa svojstava lijeka (također dio EPAR-a).
English: Why has Xiapex been approved?
Croatian: Zašto je Xiapex odobren?
English: What is Xiapex?
Croatian: Što je Xiapex?
English: The company that markets Xiapex must also ensure that all doctors expected to use the medicine are properly trained on the use of the medicine and experienced in diagnosing and managing Dupuytren's contracture or Peyronie's disease.
Croatian: Tvrtka koja stavlja lijek Xiapex u promet mora također osigurati da svi liječnici za koje se očekuje da će koristiti lijek prođu odgovarajuću obuku za primjenu lijeka te da imaju iskustva u dijagnosticiranju i upravljanju Dupuytrenovom kontrakturom i Peyronijevom bolešću.
English: There was also a greater improvement with Xiapex than placebo in patient-reported scores of how bothersome the condition was after treatment.
Croatian: Također je zapaženo veće poboljšanje s lijekom Xiapex u odnosu na placebo u rezultatima koje su dali bolesnici u pogledu razine neugode koju su osjetili nakon liječenja.
English: Xiapex was shown to be more effective at treating Dupuytren's contracture than placebo.
Croatian: Utvrđeno je da je Xiapex djelotvorniji u liječenju Dupuytrenove kontrakture od placeba.
English: It contains the active substance collagenase clostridium histolyticum.
Croatian: Sadrži djelatnu tvar kolagenazu clostridium histolyticum.
English: The cords in the palm of patients with Dupuytren's contracture and the plaques in Peyronie's disease are made of fibres of a protein called collagen.
Croatian: Niti u dlanu bolesnika s Dupuytrenovom kontrakturom i plakovima u Peyronijevoj bolesti sastoje su od vlakana bjelančevine pod nazivom kolagen.
English: When injected into a cord or a plaque, the collagenases break up the collagen fibres.
Croatian: Ako se ubrizgava u nit ili plak, kolagenaza razgrađuje vlakna kolagena, što oslabljuje i prekida nit ili plak.
English: Xiapex must be given by a doctor trained in the use of the medicine and experienced in diagnosing and managing Dupuytren's contracture or male genital problems.
Croatian: Xiapex mora primjenjivati liječnik s odgovarajućom obukom u ispravnoj primjeni lijeka i iskustvom u dijagnostici i liječenju Dupuytrenove kontrakture ili muških genitalnih problema.
English: What is Xiapex used for?
Croatian: Za što se Xiapex koristi?
English: What benefit has Xiapex shown during the studies?
Croatian: Koje su koristi lijeka Xiapex utvrđene u ispitivanjima?
English: How is Xiapex used?
Croatian: Kako se Xiapex koristi?
English: How does Xiapex work?
Croatian: Kako djeluje Xiapex?
English: How has Xiapex been studied?
Croatian: Kako je Xiapex ispitivan?
English: For the full list of all side effects and restrictions with Xiapex, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Xiapex potražite u uputi o lijeku.
English: Do this at a speed that is comfortable for you.
Croatian: Radite ovo brzinom koja Vam je ugodna.
English: Date of first authorisation: 10 November 2017
Croatian: Datum prvog odobrenja: 10. studenoga 2017.
English: You will need these supplies:
Croatian: Bit će Vam potreban sljedeći pribor:
English: Lift straight up
Croatian: Podignite ravno prema gore
English: However, the physician should ensure appropriate medical follow-up of patients.
Croatian: Međutim, liječnik treba osigurati odgovarajuće medicinsko praćenje bolesnika.
English: Week After Randomisation
Croatian: Tjedan nakon randomizacije
English: • if you have an active infection, including active tuberculosis
Croatian: • ako imate aktivnu infekciju, uključujući aktivnu tuberkulozu
English: If you stop treatment, symptoms of psoriasis may come back.
Croatian: Ako prekinete liječenje, simptomi psorijaze mogu se vratiti.
English: Your injection is now complete!
Croatian: Injekcija je sada gotova!
English: • if you have tuberculosis or have been in close contact with someone with tuberculosis
Croatian: • ako imate tuberkulozu ili ste bili u bliskom kontaktu s nekime tko ima tuberkulozu
English: Response over time
Croatian: Odgovor tijekom vremena
English: Injection is complete when the handle is pushed all the way down, you hear a click, and the green body is no longer visible.
Croatian: Injekcija je gotova kada se držač pritisne skroz prema dolje i čuje se klik, a zeleno tijelo više nije vidljivo.
English: No data are available on the response to live or inactive vaccines.
Croatian: Nema dostupnih podataka o odgovoru na živa ili inaktivirana cjepiva.
English: Place your thumb, index and middle fingers directly under the finger flange, as shown.
Croatian: Položite palac, kažiprst i srednji prst neposredno ispod rubnika za prste, kako je prikazano.
English: No specific studies have been conducted in elderly patients.
Croatian: Nisu provedena specifična ispitivanja primjene u starijih bolesnika.
English: • if you think you have an infection or have symptoms of an infection (see below under ‘Look out for infections and allergic reactions')
Croatian: • ako mislite da imate infekciju ili imate simptome infekcije (pogledajte odlomak ‘Pripazite na infekcije i alergijske reakcije' u nastavku)
English: The yellow band indicates that the needle guard is locked.
Croatian: Žuta pruga ukazuje na to da je štitnik igle zaključan.
English: • if you have an infection that does not go away or that keeps coming back
Croatian: • ako imate infekciju koja ne prolazi ili se stalno vraća
English: The last dose was at week 44 for both treatment groups.
Croatian: Posljednja doza primjenjena je u 44. tjednu u obje skupine liječenih bolesnika.
English: • if you are allergic to guselkumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na guselkumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Tremfya may increase the risk of infection.
Croatian: Tremfya može povećati rizik od infekcija.
English: There may be a small amount of blood or liquid at the injection site.
Croatian: Možda ćete vidjeti malo krvi ili tekućine na mjestu injiciranja.
English: Wash hands
Croatian: Operite ruke
English: Patients were examined at four week intervals for a total of four visits.
Croatian: Bolesnike se ocjenjivalo svaka četiri tjedna, tijekom ukupno četiri posjeta.
English: Do not remove until you are ready to inject Tremfya (See Step 2).
Croatian: Nemojte ga skinuti dok ne budete spremni injicirati lijek Tremfya (pogledajte 2. korak)
English: • if you are being treated for an infection
Croatian: • ako se liječite zbog infekcije
English: Human IgGs are known to be excreted in breast milk during the first few days after birth, and decrease to low concentrations soon afterwards; consequently, a risk to the breast-fed infant during this period cannot be excluded.
Croatian: Poznato je da se humana IgG protutijela izlučuju u majčino mlijeko prvih nekoliko dana nakon rođenja, a da se izlučivanje ubrzo nakon toga smanjuju na niske koncentracije; posljedično, rizik za dojeno dijete tijekom ovog razdoblja ne može se isključiti.
English: For further information on elimination of guselkumab, see section 5.2.
Croatian: Za dodatne informacije o eliminaciji guselkumaba vidjeti dio 5.2.
English: For further instructions on preparation and special precautions for handling, see section 6.6 and the ‘Instructions for use' leaflet.
Croatian: Za dodatne upute za pripremu i posebne mjere opreza pri rukovanju vidjeti dio 6.6 i ‘Upute za uporabu'.
English: • Front of thighs (recommended)
Croatian: • prednja strana bedara (preporučeno)
English: Clinically important active infections (e.g., active tuberculosis, see section 4.4).
Croatian: Klinički važne aktivne infekcije (npr. aktivna tuberkuloza, vidjeti dio 4.4).
English: The safety and efficacy of Tremfya in children and adolescents below the age of 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Tremfya u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
English: This instruction guide does not take the place of talking with your doctor about your medical condition or your treatment.
Croatian: Ove upute za uporabu ne zamjenjuju razgovor s liječnikom o Vašoj bolesti i njezinu liječenju.
English: There is limited information in subjects aged ≥ 65 years.
Croatian: Postoje ograničene informacije o primjeni u ispitanika u dobi od ≥ 65 godina.
English: Do not touch plunger or area above finger flange as this may cause the needle safety device to activate.
Croatian: Nemojte dodirivati klip ni područje iznad rubnika za prste jer tako možete aktivirati sigurnosnu napravu za iglu.
English: 2333CB Leiden The Netherlands
Croatian: 2333CB Leiden Nizozemska
English: Interactions with CYP450 substrates
Croatian: Interakcije sa supstratima CYP450
English: Regional disease
Croatian: Regionalna bolest
English: • 1 Sharps container (See Step 3)
Croatian: • 1 spremnik za oštre predmete (pogledajte 3. korak)
English: This medicine is for single use only.
Croatian: Ovaj je lijek namijenjen samo za jednokratnu uporabu.
English: The key efficacy results for the primary and major secondary study endpoints are shown in Table 2 below.
Croatian: Ključni rezultati za djelotvornost kod primarnih i glavnih sekundarnih mjera ishoda navedeni su u Tablici 2 u nastavku.
English: Keep Tremfya and all medicines out of reach of children.
Croatian: Čuvajte lijek Tremfya i sve lijekove izvan dohvata djece.
English: Tremfya can potentially cause serious side effects, including allergic reactions and infections.
Croatian: Tremfya može uzrokovati ozbiljne nuspojave, uključujući alergijske reakcije i infekcije.
English: Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC16.
Croatian: Farmakoterapijska skupina: Imunosupresivi, inhibitori interleukina, ATK oznaka: L04AC16.
English: What Tremfya is and what it is used for
Croatian: Što je Tremfya i za što se koristi
English: • Tremfya should not be used in pregnancy as the effects of this medicine in pregnant women are not known.
Croatian: • Tremfya se ne smije primjenjivati u trudnoći jer nisu poznati učinci tog lijeka u trudnica.
English: Do not touch needle or let it touch any surface.
Croatian: Nemojte dodirivati iglu i nemojte dopustiti da ona dodiruje druge površine.
English: Stop using Tremfya and tell your doctor or seek medical help immediately if you notice any signs indicating a possible serious allergic reaction or an infection.
Croatian: Prestanite uzimati lijek Tremfya i odmah se obratite svom liječniku ili potražite medicinsku pomoć ako primijetite bilo kakve znakove koji ukazuju na moguću ozbiljnu alergijsku reakciju ili infekciju.
English: You should not be given certain types of vaccines (live vaccines) while using Tremfya.
Croatian: Ne smijete primiti određene vrste cjepiva (živa cjepiva) dok primjenjujete lijek Tremfya.
English: Green Body
Croatian: Zeleno tijelo
English: The adverse reactions are classified by MedDRA System Organ Class and frequency, using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Nuspojave su navedene prema MedDRA klasifikaciji organskih sustava i sljedećim kategorijama učestalosti: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, toxicity to reproduction and pre- and post-natal development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, reproduktivne toksičnosti te prenatalnog i postnatalnog razvoja.
English: Antidrug antibodies were not associated with lower efficacy or development of injection-site reactions.
Croatian: Protutijela na lijek nisu bila povezana sa smanjenom djelotvornošću ni razvojem reakcija na mjestu injiciranja.
English: You should not stop using Tremfya without speaking to your doctor first.
Croatian: Ne smijete prestati primjenjivati lijek Tremfya bez prethodnog razgovora sa svojim liječnikom.
English: If needed, cover injection site with a bandage.
Croatian: Ako je potrebno, prekrijte mjesto injiciranja flasterom.
English: Tremfya has not been studied in these patient populations.
Croatian: Tremfya se nije ispitivala u tim populacijama bolesnika.
English: Position syringe at about a 45 degree angle to the skin.
Croatian: Namjestite štrcaljku pod kutom od približno 45 stupnjeva u odnosu na kožu.
English: It is important to pinch enough skin to inject under the skin and not into the muscle.
Croatian: Važno je da uhvatite dovoljno velik nabor kože da injicirate lijek pod kožu, a ne u mišić.
English: Position the pre-filled pen straight onto the skin (about 90 degrees relative to injection site).
Croatian: Namjestite napunjenu brizgalicu okomito na kožu (približno 90 stupnjeva u odnosu na mjesto injekcije).
English: Do not lift the pre-filled pen during the injection.
Croatian: Nemojte dizati napunjenu brizgalicu tijekom injekcije.
English: See section 5.3 for information on the excretion of guselkumab in animal (cynomolgus monkey) milk.
Croatian: Vidjeti dio 5.3 za informacije o izlučivanju guselkumaba u mlijeko životinja (ženki makaki majmuna).
English: If you use more Tremfya than you should
Croatian: Ako primijenite više lijeka Tremfya nego što ste trebali
English: If you forget to use Tremfya If you have forgotten to inject a dose of Tremfya, inform your doctor.
Croatian: Ako ste zaboravili primijeniti lijek Tremfya Ako ste zaboravili injicirati dozu lijeka Tremfya, obavijestite o tome svog liječnika.
English: Call your doctor to talk about any questions you may have.
Croatian: Obratite se svom liječniku sa svim pitanjima koja imate.
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravne ni neizravne štetne učinke na plodnost (vidjeti dio 5.3).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Tremfya in plaque psoriasis in one or more subsets of the paediatric population (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka lijek Tremfya u jednoj ili više podskupina pedijatrijske populacije za liječenje plak psorijaze (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: A decision should be made whether to discontinue, or abstain from initiating treatment with Tremfya, taking into account the benefit of breast-feeding to the child and the benefit of Tremfya therapy to the woman.
Croatian: Potrebno je donijeti odluku o prekidu ili suzdržavanju od započinjanja liječenja lijekom Tremfya, uzimajući u obzir korist dojenja za dijete i korist liječenja lijekom Tremfya za ženu.
English: Hold pressure over your skin with a cotton ball or gauze pad until any bleeding stops.
Croatian: Pritisnite kožu pamučnom vatom ili gazom dok krvarenje ne prestane.
English: Baseline characteristics for randomised patients were similar to those observed in VOYAGE 1 and 2.
Croatian: Početne značajke randomiziranih bolesnika bile su slične onima opaženima u ispitivanjima VOYAGE 1 i 2.
English: Overall skin disease
Croatian: Ukupna kožna bolest
English: Use your other hand to pinch skin at the injection site.
Croatian: Drugom rukom uhvatite nabor kože na mjestu injiciranja.
English: If you think you may be allergic, ask your doctor for advice before using Tremfya
Croatian: Ako mislite da ste biste mogli biti alergični, obratite se svom liječniku za savjet prije nego što primijenite lijek Tremfya.
English: EU/1/17/1234/001 1 pre-filled syringe EU/1/17/1234/002 1 pre-filled pen EU/1/17/1234/003 2 pre-filled pens EU/1/17/1234/004 2 pre-filled syringes
Croatian: EU/1/17/1234/001 1 napunjena štrcaljka EU/1/17/1234/002 1 napunjena brizgalica EU/1/17/1234/003 2 napunjene brizgalice EU/1/17/1234/004 2 napunjene štrcaljke
English: After proper training in subcutaneous injection technique, patients may inject Tremfya if a physician determines that this is appropriate.
Croatian: Nakon propisne obuke o tehnici supkutanog injiciranja, bolesnici mogu sami injicirati lijek Tremfya ako liječnik utvrdi da je to prikladno.
English: Select from the following areas for your injection:
Croatian: Odaberite jedno od sljedećih mjesta za injekciju:
English: Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku.
English: Talk to your doctor, pharmacist or nurse before using Tremfya:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite lijek Tremfya: