FrancophonIA/ELRC3.0 huggingface dataset:
English: In psoriasis patients treated with infliximab as a maintenance regimen in the absence of concomitant immunomodulators, approximately 28% developed antibodies to infliximab (see section 4.4: “Infusion reactions and hypersensitivity”).
Croatian: Približno 28% bolesnika s psorijazom liječenih infliksimabom kao terapijom održavanja bez istodobnog liječenja imunomodulatorima razvilo je protutijela na infliksimab
English: Pyelonephritis.
Croatian: Manje često: pijelonefritis
English: Lymphoma, non-Hodgkin's lymphoma, Hodgkin's disease, leukaemia, melanoma, cervical cancer.
Croatian: Rijetko: limfom, ne-Hodgkinov limfom, Hodgkinova bolest, leukemija, melanom, rak cerviksa Nepoznato: hepatosplenički limfom T-stanica (prvenstveno u adolescenata i mlađih odraslih muškaraca s Crohnovom bolešću i ulceroznim kolitisom), karcinom Merkelovih stanica
English: In clinical studies using single and multiple infliximab doses ranging from 1 to 20 mg/kg, antibodies to infliximab were detected in 14% of patients with any immunosuppressant therapy, and in 24% of patients without immunosuppressant therapy.
Croatian: protutijela na infliksimab otkrivena su u 14% bolesnika koji su primali neku imunosupresivnu terapiju te u 24% bolesnika koji nisu primali imunosupresivnu terapiju.
English: Meningitis, opportunistic infections (such as invasive fungal infections [pneumocystosis, histoplasmosis, aspergillosis, coccidioidomycosis, cryptococcosis, blastomycosis], bacterial infections [atypical mycobacterial, listeriosis, salmonellosis], and viral infections [cytomegalovirus]), parasitic infections, hepatitis B reactivation.
Croatian: salmoneloza] i virusne infekcije [citomegalovirus]), parazitske infekcije, reaktivacija hepatitisa B
English: Efficacy and safety of infliximab were assessed in two multicenter, double-blind, placebocontrolled studies 8 and 9 in patients with active ankylosing spondylitis (Bath Ankylosing
Croatian: placebom kontrolirana ispitivanja 8 i 9 u bolesnika s aktivnim ankilozantnim spondilitisom (rezultat ≥ 4 prema Bath indeksu aktivnosti ankilozantnog spondilitisa [engl.
English: In post-marketing experience, cases of anaphylactic-like reactions, including laryngeal/pharyngeal oedema and severe bronchospasm, and seizure have been associated with infliximab administration (see section 4.4).
Croatian: sarkoidozu/ reakciju nalik na sarkoidozu, intestinalne ili perianalne apscese (kod Crohnove bolesti) i ozbiljne reakcije vezane uz infuziju (vidjeti dio 4.4).
English: Tell your doctor straight away if you get signs of infection during treatment with Zessly.
Croatian: Odmah obavijestite svog liječnika ako tijekom liječenja lijekom Zessly dobijete simptome infekcije.
English: Infliximab does not cross react with TNFα from species other than human and chimpanzee.
Croatian: Infliksimab pokazuje križnu reakciju samo s TNFα ljudi i čimpanza, ali ne i drugih vrsta, stoga su konvencionalni neklinički podaci o sigurnosti primjene lijeka ograničeni.
English: infusions of infliximab 5 mg/kg, 10 mg/kg, or placebo over 6 weeks.
Croatian: Bolesnici su primili infuzije infliksimaba u dozi od 3 mg/kg odnosno 5 mg/kg ili placeba u 0., 2. i 6. tjednu.
English: Zessly 100 mg powder for concentrate infliximab
Croatian: Zessly 100 mg prašak za koncentrat infliksimab samo za i.v. primjenu
English: In patients who have several or significant risk factors for tuberculosis and have a negative test for latent tuberculosis, antituberculosis therapy should be considered before the initiation of Zessly.
Croatian: Treba razmotriti primjenu antituberkulozne terapije prije početka liječenja lijekom Zessly u bolesnika koji imaju brojne ili značajne čimbenike rizika za tuberkulozu, a rezultati testa na latentnu tuberkulozu su im negativni.
English: Chest pain, fatigue, fever, injection site reaction, chills, oedema.
Croatian: Često: bol u prsištu, umor, vrućica, reakcije na mjestu injekcije, zimica,
English: Tell your doctor straight away if you get symptoms of a nerve disease during treatment with Zessly.
Croatian: Odmah obavijestite svog liječnika ako tijekom liječenja lijekom Zessly dobijete simptome neke bolesti živčanog sustava.
English: In patients treated with Zessly, an invasive fungal infection such as aspergillosis, candidiasis, pneumocystosis, histoplasmosis, coccidioidomycosis or blastomycosis should be suspected if they develop a serious systemic illness, and a physician with expertise in the diagnosis and treatment of invasive fungal infections should be consulted at an early stage when investigating these patients.
Croatian: U bolesnika liječenih lijekom Zessly u kojih se razvije ozbiljna sistemska bolest treba posumnjati na neku invazivnu gljivičnu infekciju poput aspergiloze, kandidijaze, pneumocistoze, histoplazmoze, kokcidioidomikoze ili blastomikoze.
English: Your baby should not receive a ‘live vaccine', such as BCG (used to prevent tuberculosis) within 6 months after birth.
Croatian: Vaše dijete ne smije primiti "živo cjepivo", kao što je BCG
English: During Zessly treatment, other concomitant therapies, e.g. corticosteroids and immunosuppressants should be optimised.
Croatian: Tijekom liječenja lijekom Zessly treba optimalno prilagoditi istodobnu terapiju drugim lijekovima,
English: Study 13
Croatian: ispitivanje 1
English: AZA Monotherapy infliximab Monotherapy infliximab + AZA Combination Therapy
Croatian: Kombinirana terapija infliksimab + AZA
English: • Bleeding in the stomach or intestines, diarrhoea, indigestion, heartburn, constipation
Croatian: • otežano ili bolno disanje, bol u prsnom košu • krvarenje u želucu ili crijevima, proljev, loša probava, žgaravica, zatvor
English: Disodium succinate hexahydrate Succinic acid
Croatian: 6.1 Popis pomoćnih tvari dinatrijev sukcinat heksahidrat sukcinatna kiselina saharoza polisorbat 80
English: • Severely decreased numbers of white blood cells have been reported in infants born to women treated with infliximab during pregnancy.
Croatian: • U dojenčadi čije su majke tijekom trudnoće liječene infliksimabom prijavljeno je značajno smanjenje bijelih krvnih stanica.
English: Cases of malignancies, including lymphoma, have also been reported in the post-marketing setting (see section 4.4).
Croatian: Slučajevi zloćudnih bolesti, uključujući limfom, prijavljeni su i nakon stavljanja lijeka u promet
English: At 54 weeks, 44.9% of patients in the combined infliximab treatment group were in clinical response compared to 19.8% in the placebo treatment group (p < 0.001).
Croatian: Djelotvornost infliksimaba tijekom 54. tjedna ispitivala se u ispitivanju 6. U 54. je tjednu klinički odgovor imalo 44,9% bolesnika u objema skupinama liječenima infliksimabom, u odnosu na 19,8%
English: Tell your doctor straight away if you get signs of TB during treatment with Zessly.
Croatian: Odmah obavijestite svog liječnika ako tijekom liječenja lijekom Zessly dobijete simptome tuberkuloze.
English: Caution should be exercised in considering treatment of patients with increased risk for malignancy due to heavy smoking.
Croatian: U bolesnika koji imaju povećan rizik za razvoj maligne bolesti jer su teški pušači mogućnost liječenja infliksimabom treba razmotriti uz oprez.
English: A reduction in the rate of the progression of structural joint damage (erosions and joint space narrowing) was observed in all infliximab groups at 54 weeks (Table 3).
Croatian: primijećeno je nakon 54 tjedna u svim skupinama bolesnika koji su primali infliksimab (Tablica 3).
English: Percentage of subjects in clinical remission and sustained remission
Croatian: Postotak ispitanika u kliničkoj remisiji i održanoj remisiji Klinička remisija u 8. tjednua
English: • Eye problems including blurred or reduced vision, puffy eyes or sties
Croatian: • problemi s očima uključujući zamagljen ili oslabljen vid, natečene oči ili ječmenac • novonastalo zatajenje srca ili pogoršanje postojećeg, usporen ritam srca
English: Gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation.
Croatian: Često: gastrointestinalno krvarenje, proljev, dispepsija, gastroezofagealni refluks, konstipacija Manje često: perforacija crijeva, stenoza crijeva, divertikulitis, pankreatitis, heilitis
English: For results see Table 6.
Croatian: Zbirni podaci iz ispitivanja 6 i 7
English: Allergic respiratory symptom.
Croatian: Često: alergijske reakcije dišnog sustava
English: The efficacy of a single dose treatment with infliximab was assessed in 108 patients with active
Croatian: Djelotvornost liječenja jednokratnom dozom infliksimaba ispitana je u 108 bolesnika s aktivnom Crohnovom bolešću (indeks aktivnosti Crohnove bolesti, engl.
English: Elevations of ALT ≥ 5 x Upper
Croatian: ≥ 5 x GGN
English: All patients were required to be on a stable dose of 6-MP, AZA or MTX (35% were also receiving corticosteroids at baseline).
Croatian: AZA ili MTX (35% ih je na početku ispitivanja primalo i kortikosteroide).
English: • Liver failure
Croatian: • otečeni limfni čvorovi
English: Efficacy and safety were assessed in two multicenter, double-blind, placebo-controlled studies in patients with active psoriatic arthritis (studies 10 and 11).
Croatian: U drugom ispitivanju (ispitivanje 11), djelotvornost i sigurnost primjene infliksimaba ispitivane su u 200 bolesnika s aktivnim psorijatičnim artritisom (≥ 5 otečenih zglobova i ≥ 5 bolnih zglobova).
English: Percentage of subjects with mucosal healing
Croatian: Postotak ispitanika s cijeljenjem sluznice
English: • Psoriasis, skin problems such as eczema and hair loss
Croatian: • psorijaza, problemi s kožom kao što su ekcemi i gubitak kose • reakcije na mjestu davanja injekcije kao što su bol, oteklina, crvenilo ili svrbež
English: After preparation each ml contains 10 mg of infliximab.
Croatian: jedan ml sadrži 10 mg infliksimaba.
English: • Tell your doctor before you are given Zessly if you are a carrier of hepatitis B or have ever had it.
Croatian: • Prije nego počnete primati Zessly, obavijestite svog liječnika ako ste nositelj virusa hepatitisa B
English: Placebo → infliximab 5 mg/kg (at week 24)
Croatian: 5 mg/kg (u 24. tjednu)
English: Cardiac failure (new onset or worsening), arrhythmia, syncope, bradycardia.
Croatian: Manje često: zatajenje srca (novonastalo ili pogoršanje postojećeg), aritmija,
English: Patients must be monitored closely for infections including tuberculosis before, during and after treatment with Zessly.
Croatian: Prije, tijekom i nakon liječenja lijekom Zessly bolesnike se mora pomno nadzirati kako bi se uočile infekcije, uključujući tuberkulozu.
English: For patients who have resided in or travelled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of Zessly treatment should be carefully considered before initiation of Zessly therapy.
Croatian: Prije uvođenja lijeka Zessly treba pažljivo ocijeniti koristi i rizike liječenja ovim lijekom u bolesnika koji su boravili ili putovali u područja za koja su karakteristične endemske invazivne gljivične infekcije kao što su histoplazmoza, kokcidioidomikoza ili blastomikoza.
English: Autoantibody positive.
Croatian: Manje često: pozitivan nalaz na autoprotutijela
English: Zessly is indicated for treatment of severe, active Crohn's disease, in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies.
Croatian: Zessly je indiciran za liječenje teške, aktivne Crohnove bolesti u djece i adolescenata u dobi između 6 i 17 godina, koji nisu odgovorili na konvencionalnu terapiju uključujući kortikosteroid,
English: Adult ulcerative colitis
Croatian: Ulcerozni kolitis u odraslih bolesnika
English: Further treatment with Zessly must not be given if a patient develops a serious infection or sepsis.
Croatian: Ako se u bolesnika razvije teška infekcija ili sepsa, liječenje lijekom Zessly ne smije se nastaviti.
English: e
Croatian: U
English: It is recommended that paediatric patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating Zessly therapy.
Croatian: Prije početka terapije lijekom Zessly, preporučuje se po mogućnosti cijepiti pedijatrijske bolesnike u skladu s važećim programom cijepljenja.
English: Treatment is continued over a period of up to 72 hours.
Croatian: Terapija se nastavlja tijekom razdoblja do maksimalno 72 sata.
English: What is Zalviso and what is it used for?
Croatian: Što je Zalviso i za što se koristi?
English: Why is Zalviso approved?
Croatian: Zašto je Zalviso odobren?
English: The full EPAR and risk management plan summary for Zalviso can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Zalviso nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Zalviso is a ‘hybrid medicine'.
Croatian: Zalviso je „hibridni lijek”.
English: The device locks for 20 minutes after the patient has taken a tablet and does not allow the patient to take more than 3 doses in one hour.
Croatian: Uređaj se zaključava na 20 minuta nakon što je bolesnik uzeo tabletu i ne dozvoljava bolesniku da uzme više od 3 doze unutar jednog sata.
English: The tablets must be allowed to dissolve under the tongue and must not be chewed or swallowed.
Croatian: Tablete se moraju otopiti ispod jezika i ne smiju se žvakati ili progutati.
English: What are the risks associated with Zalviso?
Croatian: Koji su rizici povezani s lijekom Zalviso?
English: However, considering the fact that post-operative pain improves by itself over time as well as the potential for addiction or the body becoming used to the opioid and requiring larger doses, the medicine and its administration device should only be used in a hospital setting, and restricted to use for a maximum duration of 72 hours.
Croatian: No, uzimajući u obzir da se postoperativna bol poboljšava tijekom vremena kao i izgledi za razvoj ovisnosti ili da se tijelo navikne na opioid te da mu je potrebna veća doza, lijek i uređaj za njegovu primjenu trebaju se koristiti samo u bolničkom okruženju i ograničiti se na maksimalno razdoblje od 72 sata.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Zalviso is available in a different form.
Croatian: To znači da je sličan „referentom lijeku” koji sadrži iste djelatne tvari, no Zalviso je dostupan u drugom obliku.
English: The most serious side effect is respiratory depression (impaired breathing) which could potentially lead to the patient stopping breathing altogether.
Croatian: Najozbiljnija nuspojava je respiratorna depresija (otežano disanje) koja može potencijalno rezultirati potpunim prestankom disanja kod bolesnika.
English: What measures are being taken to ensure the safe and effective use of Zalviso?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zalviso?
English: Zalviso must not be used in patients who already have significant impaired breathing.
Croatian: Zalviso se ne smije koristiti u bolesnika koji već imaju značajno otežano disanje.
English: The main measure of effectiveness was based on a patient score that measured the decrease in intensity of pain over 48 hours of treatment.
Croatian: Glavna mjera djelotvornosti temeljila se na rezultatu bolesnika koji je bio pokazatelj smanjenja intenziteta boli tijekom razdoblja od 48 sati terapije.
English: Of 177 patients using Zalviso, 139 rated their pain control as excellent or good (79%), compared with 118 of 180 (66%) using morphine.
Croatian: Od 177 bolesnika koji su primjenjivali Zalviso, 139 ocijenilo je svoju kontrolu boli kao odličnu ili dobru (79%), u usporedbi s 118 od 180 (66%) uz primjenu morfija.
English: Regarding safety, the side effects were those expected of opioids, and were considered manageable.
Croatian: Vezano uz sigurnost, nuspojave su bile iste onima koje se očekuju od opioida, i smatraju se upravljivima.
English: This is a summary of the European public assessment report (EPAR) for Zalviso.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Zalviso.
English: This allows the medicine to be transported to receptors in the brain and spinal cord where sufentanil acts to relieve pain.
Croatian: Ovo omogućuje prijenos lijeka do receptora u mozgu i kralježnične moždine gdje sufentanil djeluje tako da ublaži bol.
English: Zalviso is available as sublingual tablets containing 15 micrograms of sufentanil.
Croatian: Zalviso dostupan je kao sublingualne tablete koje sadrže 15 mikrograma sufentanila.
English: In both cases Zalviso was compared with placebo (a dummy treatment).
Croatian: U oba slučaja lijek Zalviso bio je uspoređen s placebom (lažnim liječenjem).
English: Other information about Zalviso
Croatian: Ostale informacije o lijeku Zalviso
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zalviso's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Zalviso nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: The device also uses an identifier so that only the patient who has been given a special thumb tag can release tablets.
Croatian: Uređaj se također koristi kao identifikator tako da bolesnik koji je dobio poseban ježičak za palac može otpustiti tablete.
English: The tablets are only for use in hospital and can only be obtained with a prescription from a doctor experienced in treating patients with opioids.
Croatian: Tablete su dostupne samo za uporabu u bolnici i izdaju se na recept od strane liječnika iskusnog u liječenju bolesnika opioidima.
English: When the patient places a Zalviso tablet under the tongue, a dose of sufentanil is rapidly absorbed into the blood stream through the blood vessels in the lining of the mouth.
Croatian: Kada bolesnik stavi tabletu lijeka Zalviso ispod jezika, doza sufentanila se brzo apsorbira u krvotok kroz krvne žile u ovojnici usta.
English: A risk management plan has been developed to ensure that Zalviso is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Zalviso.
English: It is not intended to provide practical advice on how to use Zalviso.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Zalviso.
English: Because Zalviso is a hybrid generic, the applicant presented data on the reference medicine in addition to results from its own studies.
Croatian: Budući da je Zalviso hibridni generički lijek, podnositelj zahtjeva dostavio je podatke o referentnom lijeku uz rezultate iz svojih vlastitih ispitivanja.
English: One main study involved 178 patients who had abdominal surgery (surgery on the belly) and another involved 426 patients who had surgery on the knee or hip.
Croatian: Jedno glavno ispitivanje obuhvatilo je 178 bolesnika koji su imali abdominalni kirurški zahvat (kirurški zahvat na želucu), dok je drugo ispitivanje obuhvatilo 426 bolesnika koji su imali kirurški zahvat na koljenu ili kuku.
English: The Committee considered that an additional option for patient-controlled pain relief immediately after surgery, when the pain is worst, was beneficial, especially since it did not need to be given into a vein.
Croatian: Odbor je zaključio da je dodatna mogućnost za ublažavanje boli koju kontrolira bolesnik trenutno nakon kirurškog zahvata, ako se bol pogorša, što je korisno posebno ako se ne mora primjenjivati u venu.
English: The most common side effects with Zalviso (which may affect more than 1 in 10 people) are nausea (feeling sick) and vomiting.
Croatian: Najčešće nuspojave lijeka Zalviso (mogu se javiti u više od 1 na 10 osoba) su mučnina (osjećaj slabosti), povraćanje, proljev i zatvor.
English: A third main study compared Zalviso with a patient-controlled pain relief system using morphine, another opioid, and involved 359 patients who had undergone major abdominal, knee or hip surgery.
Croatian: Treće glavno ispitivanje usporedilo je Zalviso s sustavom za ublažavanje boli kojeg kontrolira bolesnik uz primjenu morfina, drugog opioida, i obuhvatilo je 359 bolesnika koji su podvrgnuti većem kururškom zahvatu na želucu, koljenu ili kuku.
English: The reference medicine for Zalviso is called Sufenta Forte, and is available as a solution for injection, whereas Zalviso is available as sublingual tablets (tablets to be dissolved under the tongue).
Croatian: Referentni lijek za Zalviso je Sufenta Forte, koji je dostupan kao otopina za injekciju, dok je Zalviso dostupan kao sublingualne tablete (tablete za topljenje ispod jezika).
English: How is Zalviso used?
Croatian: Kako se Zalviso koristi?
English: For knee and hip surgery the decrease in pain intensity was around 88 points greater with Zalviso (76 versus -11) than with placebo.
Croatian: U slučaju operacije koljena i kuka smanjenje u intenzitetu boli bilo je oko 88 točaka veće s lijekom Zalviso (76 u odnosu na -11) u usporedbi s placebom.
English: For abdominal surgery, the average decrease in pain intensity was 50 points greater with Zalviso than with placebo (106 versus 56).
Croatian: U slučaju abdominalnog kirurškog zahvata, prosječno smanjenje u intenzitetu boli bilo je za 50 bodova veće s lijekom Zalviso u odnosu na placebo (160 u odnosu na 56).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zalviso, 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 za lijek Zalviso nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: For more information about treatment with Zalviso, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Zalviso pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: The patient places the Zalviso tablets under their tongue when needed using a special device.
Croatian: Bolesnik stavlja lijek Zalviso ispod jezika kada je to potrebno i uz pomoć posebnog uređaja.
English: The active substance in Zalviso, sufentanil, is an opioid.
Croatian: Sufentanil, djelatna tvar u lijeku Zalviso, je opioid.
English: What benefits of Zalviso have been shown in studies?
Croatian: Koje su koristi lijeka Zalviso utvrđene u ispitivanjima?
English: For practical information about using Zalviso, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Zalviso pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: For the full list of side effects and restrictions with Zalviso, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja koje su zabilježene s lijekom Zalviso potražite u uputi o lijeku.
English: How does Zalviso work?
Croatian: Kako djeluje Zalviso?
English: Zalviso is an opioid (a strong painkiller) that is used to treat pain occurring in adults after an operation.
Croatian: Zalviso je opioid (snažni analgetik) koji se koristi za liječenje boli koja se pojavljuje u odraslih osoba nakon kirurškog zahvata Sadrži djelatnu tvar sufentanil.
English: This will help to protect against the diseases caused by these viruses.
Croatian: To pomaže pri zaštiti od bolesti koju uzrokuju virusi.
English: These side effects were normally mild or moderate.
Croatian: Te su nuspojave većinom bile blage ili umjerene.
English: These virus-like particles are not capable of causing infection or disease.
Croatian: Ove čestice slične virusu ne mogu uzrokovati infekciju niti bolest.