FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to an increased risk of infection, patients taking Simponi must be monitored closely for infections, including tuberculosis, during and for up to 5 months after treatment.
Croatian: Zbog povećanja rizika od infekcije, bolesnike koji uzimaju Simponi potrebno je pažljivo nadzirati za slučaj pojave infekcija, uključujući tuberkulozu, tijekom terapije i do pet mjeseci nakon terapije.
English: Simponi must not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body).
Croatian: Simponi se ne smije primjenjivati u bolesnika s tuberkulozom, drugim teškim infekcijama i umjerenim ili teškim zatajenjem srca (nemogućnost srca da pumpa dovoljne količine krvi u tijelu).
English: Simponi is used in combination with methotrexate (a medicine that acts on the immune system).
Croatian: Simponi se primjenjuje u kombinaciji s metotreksatom (lijekom koji djeluje na imunosni sustav).
English: The most common side effects with Simponi are upper respiratory tract infections such as infections of the nose, throat or voice box.
Croatian: Najčešće nuspojave lijeka Simponi su infekcije gornjih dišnih putova poput infekcija nosa, grla ili glasnica.
English: It can be used in adults who have not responded adequately to other treatments including methotrexate whose disease is moderate to severe, and in patients who have not previously been treated with methotrexate whose disease is severe and progressive;
Croatian: Može se primjenjivati u odraslih bolesnika koji nisu adekvatno reagirali na druge terapije, uključujući i terapiju metotreksatom, čija je bolest umjerena do ozbiljna, te u bolesnika koji prethodno nisu bili liječeni metotreksatom, a čija je bolest ozbiljna i progresivna;
English: The European Medicines Agency decided that Simponi's benefits are greater than its risks and that it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Simponi nadmašuju s njim povezane rizike te da može biti odobren za primjenu u Europskoj uniji.
English: What are the risks associated with Simponi?
Croatian: Koji su rizici povezani s lijekom Simponi?
English: Treatment with Simponi and methotrexate was not compared with placebo or any other treatment.
Croatian: Terapija lijekom Simponi i metotreksatom nije uspoređena s placebom ili bilo kojom drugom terapijom.
English: Golimumab has been designed to attach to and block a substance in the body called tumour necrosis factor alpha (TNF-α).
Croatian: Golimumab je osmišljen kako bi vezivanjem na nju blokirao tvar u organizmu naziva faktor nekroze tumora alfa (TNF-α-).
English: Why is Simponi authorised in the EU?
Croatian: Zašto je lijek Simponi odobren u EU-u?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Simponi have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Simponi također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: As for all medicines, data on the use of Simponi is continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Simponi kontinuirano se prate.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body.
Croatian: Monoklonsko protutijelo je protutijelo (vrsta bjelančevine) namijenjeno prepoznavanju određene strukture (nazvane antigen) u organizmu i vezivanju na nju.
English: An overview of Simponi and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Simponi i zašto je odobren u EU-u
English: Simponi has been shown to be effective at reducing the number and severity of symptoms in patients with the conditions for which it is authorised.
Croatian: Lijek Simponi pokazao se djelotvornim u smanjenju broja i težine simptoma u bolesnika s bolestima za čije je liječenje odobren.
English: Simponi is available as pre-filled pens and syringes containing a solution for injection under the skin.
Croatian: Simponi je dostupan u obliku napunjenih brizgalica i štrcaljki koje sadrže otopinu za injektiranje pod kožu.
English: Side effects reported with Simponi are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Simponi pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Simponi is used in combination with methotrexate.
Croatian: Simponi se primjenjuje u kombinaciji s metotreksatom.
English: Patients should show this card when seeing a healthcare professional, so that they are aware that the patient is using Simponi.
Croatian: Bolesnici bi tu karticu trebali pokazati kod svakog liječničkog pregleda, kako bi liječnik znao da bolesnik uzima lijek Simponi.
English: Data from X-rays taken before and after two years of treatment showed less joint damage in patients receiving Simponi than in those receiving placebo.
Croatian: Podatci iz rendgenskih snimaka napravljenih prije i nakon dvije godine terapije pokazali su manje oštećenje zglobova u bolesnika koji su primali lijek Simponi u odnosu na one koji su primali placebo.
English: For polyarticular juvenile idiopathic arthritis, 173 patients between 2 and 18 years old who had not responded adequately to treatment with methotrexate were treated for 12 weeks with Simponi and methotrexate.
Croatian: Kod poliartikularnog juvenilnog idiopatskog artritisa, 173 bolesnika u dobi od 2 i 18 godina, koji nisu adekvatno odgovorili na terapiju metotreksatom primilo je terapiju lijekom Simponi i metotreksatom.
English: Simponi can only be obtained with a prescription and treatment must be initiated and supervised by a qualified doctor who has experience in the diagnosis and treatment of the diseases that Simponi is used to treat.
Croatian: Lijek Simponi izdaje se samo na liječnički recept, a liječenje treba započeti i nadzirati liječnik s iskustvom u dijagnosticiranju i liječenju bolesti koje se liječe lijekom Simponi.
English: • polyarticular juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints).
Croatian: • poliartikularnog juvenilnog idiopatskog artritisa (rijetke dječje bolesti koja uzrokuje upalu velikog broja zglobova).
English: The active substance in Simponi, golimumab, is a monoclonal antibody.
Croatian: Djelatna tvar lijeka Simponi, golimumab, monoklonsko je protutijelo.
English: How does Simponi work?
Croatian: Kako djeluje Simponi?
English: The recommended dose depends on the disease Simponi is used to treat and the response of the patient.
Croatian: Preporučena doza lijeka Simponi ovisi o bolesti koju treba liječiti i reakciji bolesnika na terapiju.
English: What benefits of Simponi have been shown in studies?
Croatian: Koje su koristi od lijeka Simponi utvrđene u ispitivanjima?
English: Simponi is used in adults who have not responded adequately to other treatments.
Croatian: Simponi se primjenjuje u odraslih koji nisu adekvatno reagirali na druge terapije.
English: It is used in children from 2 years of age who have not responded adequately to treatment with methotrexate.
Croatian: Primjenjuje se u djece od dvije godine i starijih koja nisu adekvatno reagirala na terapiju metotreksatom.
English: Of these patients, 87% of (151 out of 173) had 30% reduction in the number and severity of symptoms after 16 weeks.
Croatian: Od tih je bolesnika u njih 87 % (151 od 173) došlo do 30 %-tnog smanjenja broja i težine simptoma nakon 16 tjedana.
English: For more information about using Simponi, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Simponi pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: • active and progressive psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).
Croatian: • aktivnog i progresivnog psorijatičnog artritisa (bolesti koja uzrokuje crvene ljuskave lezije na koži i upalu zglobova).
English: The first study, involving 1,065 patients, compared different doses of Simponi with placebo as induction treatment.
Croatian: U prvom ispitivanju na 1 065 bolesnika uspoređivane su različite doze lijeka Simponi s placebom kao indukcijskom terapijom.
English: Patients treated with Simponi must be given a reminder card that summarises the safety information about the medicine and when to seek medical advice.
Croatian: Bolesnici na terapiji lijekom Simponi moraju dobiti posebnu karticu u kojoj su sažete informacije o sigurnoj primjeni lijeka te u kojim slučajevima treba potražiti liječničku pomoć.
English: It can be used alone or in combination with methotrexate;
Croatian: Može se primjenjivati kao monoterapija ili u kombinaciji s metotreksatom.
English: Simponi is used in adults who have not responded adequately to, or cannot use, conventional treatment;
Croatian: Simponi se primjenjuje u odraslih koji nisu adekvatno reagirali na konvencionalnu terapiju ili je ne mogu primiti.
English: This substance is involved in causing inflammation and is found at high levels in patients with the diseases that Simponi is used to treat.
Croatian: Ta je tvar uključena u nastanak upale te se u visokim razinama nalazi u bolesnika oboljelih od bolesti koje se liječe lijekom Simponi.
English: In the third study, in patients who had not been previously treated with either methotrexate or another anti-TNF-α, after 24 weeks, 40% of patients (64 out of 159) who received Simponi with methotrexate achieved 50% reductions compared with 29% of patients (47 out of 160) who received placebo and methotrexate.
Croatian: U trećem ispitivanju u bolesnika koji prethodno nisu bili liječeni ni metotreksatom ni drugim anti-TNF-, nakon 24 tjedna u 40 % bolesnika (64 od 159) koji su primili lijek Simponi s metotreksatom došlo je do 50 %-tnog smanjenja, u usporedbi s 29 % bolesnika (47 od 160) koji su primili placebo i metotreksat.
English: The second study, involving 1,228 patients, compared Simponi 50 or 100 mg with placebo as maintenance treatment.
Croatian: U drugom ispitivanju na 1 228 bolesnika, uspoređivane su doze lijeka Simponi od 50 ili 100 mg s placebom kao terapijom održavanja.
English: After training, patients may inject themselves with Simponi if their doctor agrees.
Croatian: Nakon obuke i uz suglasnost liječnika, bolesnici si sami mogu injektirati lijek Simponi.
English: • axial spondyloarthritis (a disease causing inflammation and pain in the joints of the spine), including: - adults with severe active ankylosing spondylitis who have not responded adequately to other treatments; - adults with severe non-radiographic axial spondyloarthritis (when there are objective signs of inflammation but no abnormalities seen on x-ray) who have not responded adequately or are intolerant to anti-inflammatory medicines called non-steroidal anti-inflammatory drugs (NSAIDs);
Croatian: - odrasle bolesnike s ozbiljnim aksijalnim spondiloartritisom bez radiografskih dokaza (kada postoje objektivni znakovi upale, ali abnormalnosti nisu uočene na rendgenskoj snimci) koji nisu adekvatno reagirali na protuupalne lijekove naziva nesteroidni protuupalni lijekovi (NSAID-ovi) ili ih ne podnose;
English: For non-radiographic axial spondyloarthritis, Simponi was compared with placebo over 16 weeks in one main study involving 198 patients who had the disease without evidence of ankylosing spondylitis but with signs of inflammation and who had not responded adequately to treatment with NSAIDs.
Croatian: Kod aksijalnog spondiloartritisa Simponi je uspoređen s placebom tijekom 16 tjedana u jednom glavnom ispitivanju koje je uključivalo 198 bolesnika s ovom bolešću bez dokaza ankilozantnog spondilitisa, ali sa znakovima upale, koji nisu adekvatno reagirali na terapiju NSAID-ovima.
English: In the first study, around 51% of patients receiving induction treatment with Simponi (starting at 200 mg) responded to treatment after 6 weeks, compared with around 30% of patients given placebo.
Croatian: U prvom je ispitivanju 51 % bolesnika koji su primali indukcijsku terapiju lijekom Simponi (s početnom dozom od 200 mg) reagiralo na liječenje nakon 6 tjedana, u usporedbi s oko 30 % bolesnika koji su primili placebo.
English: Simponi contains the active substance golimumab.
Croatian: Lijek Simponi sadrži djelatnu tvar golimumab.
English: • moderately to severely active ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut).
Croatian: • umjerenog do teškog aktivnog ulceroznog kolitisa (bolesti koja uzrokuje upalu i čireve na stijenci crijeva).
English: In the first study, in which patients were also given methotrexate, after 14 weeks, 55% patients who received Simponi (49 out of 89) achieved 20% reductions compared with 33% (44 out of 133) of patients who received placebo.
Croatian: U prvom ispitivanju u kojem su bolesnici također primili metotreksat, nakon 14 tjedana u 55 % bolesnika koji su primili lijek Simponi (49 od 89) došlo je do 20 %-tnog smanjenja, u usporedbi s 33 % (44 od133) bolesnika koji su primili placebo.
English: In the second study, after 14 weeks, 35% of patients who received Simponi alone (54 out of 153) achieved 20% reductions in the number and severity of symptoms compared with 18% of patients who received placebo (28 out of 155).
Croatian: U drugom ispitivanju, nakon 14 tjedana, u 35 % bolesnika koji su primili samo Simponi (54 od 153) došlo je do 20 %-tnog smanjenja broja i težine simptoma, u usporedbi s 18 % bolesnika koji su primili placebo (28 od 155).
English: • active rheumatoid arthritis (a disease causing inflammation of the joints).
Croatian: • aktivnog reumatoidnog artritisa (bolesti koja uzrokuje upalu zglobova).
English: In the second study, around 50% of patients receiving maintenance treatment with Simponi 100 mg and around 47% of those given Simponi 50 mg responded to treatment after 54 weeks, compared with around 31% of patients given placebo.
Croatian: U drugom je ispitivanju oko 50 % bolesnika koji su primili terapiju održavanja lijekom Simponi od 100 mg i oko 47 % bolesnika koji su primili Simponi od 50 mg reagiralo na liječenje nakon 54 tjedna, u usporedbi s 31 % bolesnika koji su primili placebo.
English: How is Simponi used?
Croatian: Kako se Simponi primjenjuje?
English: For rheumatoid arthritis, Simponi was compared with placebo (a dummy treatment) in three studies involving 1,542 patients with moderate to severe rheumatoid arthritis, including patients who had not received or responded adequately to other treatments.
Croatian: Kod reumatoidnog artritisa Simponi je uspoređen s placebom (prividnim liječenjem) u trima ispitivanjima koja su obuhvatila 1 542 bolesnika s umjerenim do ozbiljnim reumatoidnim artritisom, uključujući bolesnike koji prethodno nisu primili drugu terapiju ili na nju nisu adekvatno reagirali.
English: For ankylosing spondylitis, Simponi was compared with placebo over 24 weeks in one main study involving 356 patients who had not responded adequately to other treatments.
Croatian: Kod ankilozantnog spondilitisa Simponi je uspoređen s placebom tijekom 24 tjedna u jednom glavnom ispitivanju na 356 bolesnika koji nisu adekvatno reagirali na druge terapije.
English: For the full list of restrictions with Simponi, see the package leaflet.
Croatian: Potpuni popis ograničenja za lijek Simponi potražite u uputi o lijeku.
English: For psoriatic arthritis, Simponi was compared with placebo over 24 weeks in one main study involving 405 patients who had not responded adequately to other treatments.
Croatian: Kod psorijatičnog artritisa, Simponi je uspoređen s placebom tijekom 24 tjedna u jednom glavnom ispitivanju koje je obuhvatilo 405 bolesnika koji nisu adekvatno reagirali na druge terapije.
English: Of the patients who received Simponi, 71% (69 out of 97) had 20% reductions in the number and severity of symptoms after 16 weeks, compared with 40% of patients who were given placebo (40 out of 100).
Croatian: U bolesnika koji su primali Simponi, u 71 % (69 od 97) njih došlo je do 20 %-tnog smanjenja broja i težine simptoma nakon 16 tjedana, u usporedbi s 40 % bolesnika koji su primali placebo (40 od 100).
English: Of the patients who received Simponi, 59% (82 out of 138) had 20% reductions in the number and severity of symptoms after 14 weeks, compared with 22% of patients who were given placebo (17 out of 78).
Croatian: U bolesnika koji su primali Simponi, u 59 % (82 od 138) njih došlo je do 20 %-tnog smanjenja broja i težine simptoma, u usporedbi s 22 % bolesnika koji su primali placebo (17 od 78).
English: For ulcerative colitis, Simponi was compared with placebo in two main studies in patients who had not responded to or could not use other treatments.
Croatian: Kod ulceroznog kolitisa Simponi je uspoređen s placebom u dvama glavnim ispitivanjima na bolesnicima koji nisu reagirali na prethodne terapije ili za koje druge terapije nisu bile primjerene.
English: Of the patients who received Simponi, 51% (74 out of 146) had 20% reductions in the number and severity of symptoms after 14 weeks, compared with 9% of patients who were given placebo (10 out of 113).
Croatian: U bolesnika koji su primali Simponi, u 51 % (74 od 146) njih došlo je do 20 %-tnog smanjenja broja i težine simptoma, u usporedbi s 9 % bolesnika koji su primali placebo (10 od 113).
English: For the full list of side effects reported with Simponi, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Simponi potražite u uputi o lijeku.
English: Annex IV
Croatian: Dodatak IV.
English: 17 June 2015
Croatian: 17. lipnja 2015.
English: Adoption of CMDh agreement:
Croatian: Usvajanje sporazuma CMDh-a:
English: 16 October 2015
Croatian: 16. listopada 2015.
English: Implementation of the agreement by the Member States (submission of the variation type IB by the Marketing Authorisation Holder):
Croatian: Provedba sporazuma u državama članicama (nositelj odobrenja za stavljanje lijeka u promet predaje izmjenu tipa IB):
English: May 2015 CMDh meeting
Croatian: Sastanak CMDh-a u svibnju 2015.
English: Transmission to National Competent Authorities of the translations of the annexes to the agreement:
Croatian: Dostavljanje prijevoda dodataka sporazumu nacionalnim nadležnim tijelima:
English: Data in the elderly patients are very limited.
Croatian: Podaci za starije bolesnike vrlo su ograničeni.
English: Very common: may affect more than 1 in 10 people are listed below:
Croatian: Vrlo često: mogu se javiti u više od 1 na 10 osoba, navedene su niže:
English: If you forget to take a dose,take your capsules as soon as you remember.
Croatian: Ako ste zaboravili uzeti dozu, uzmite kapsule čim se sjetite.
English: Date of latest renewal: 22 July 2016
Croatian: Datum posljednje obnove odobrenja: 22. srpnja 2016.
English: Co. Meath,
Croatian: Meath,
English: Eventually, the amyloid causes the symptoms of this disease.
Croatian: Na kraju će amiloid izazvati simptome ove bolesti.
English: Component of a multipack, can't be sold separately.
Croatian: Sastavni dio višestrukog pakiranja, ne može se prodavati zasebno.
English: The Physician Information Leaflet should contain the following key messages:
Croatian: Informativni letak za liječnike treba sadržavati sljedeće ključne poruke:
English: • Vaginal infection in women
Croatian: • vaginalna infekcija u žena
English: In case of overdose, standard supportive measures should be instituted as required.
Croatian: U slučaju predoziranja, po potrebi se trebaju uvesti standardne potporne mjere.
English: 15 INSTRUCTIONS ON USE
Croatian: 15. UPUTE ZA UPORABU
English: Tafamidis is highly protein bound (99.9%) in plasma.
Croatian: Tafamidis je u visokom postotku (99,9%) vezan za proteine u plazmi.
English: No dosage adjustment is required for elderly patients (≥ 65 years).
Croatian: Nije potrebno prilagođavati dozu u starijih bolesnika (u dobi od ≥ 65 godina).
English: Talk to your doctor, pharmacist or nurse before taking Vyndaqel.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Vyndaqel.
English: TTR is a protein that carries other substances, such as hormones, through the body.
Croatian: TTR je protein koji prenosi druge tvari, kao što su hormoni, po tijelu.
English: Dose and time linearity
Croatian: Linearnost doze i vremena
English: Amyloid can build up around your nerves and in other places in your body, preventing them from working normally.
Croatian: Amiloid se može nakupiti oko živaca i na drugim mjestima u tijelu i tako spriječiti njihovo normalno funkcioniranje.
English: • The active substance is tafamidis.
Croatian: • Djelatna tvar je tafamidis.
English: You should not take more capsules than your doctor tells you to.
Croatian: Ne smijete uzeti više kapsula nego što Vam je rekao liječnik.
English: Do not stop taking Vyndaqel without first speaking to your doctor.
Croatian: Nemojte prestati uzimati Vyndaqel bez prethodnog razgovora s liječnikom.
English: If you take more capsules than you have been told to take, contact your doctor.
Croatian: Ako uzmete više kapsula nego što Vam je rečeno da uzmete, obratite se svom liječniku.
English: If you are allergic to tafamidis meglumine or any of the other ingredients of this medicine (listed in section 6).
Croatian: ako ste alergični na tafamidismeglumin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Liver effects were seen at doses above (>3) human exposure and have generally been shown to be reversible.
Croatian: Učinci na jetru opaženi su pri dozama većima (>3) od izloženosti ljudi i općenito su se pokazali reverzibilnima.
English: Tafamidis meglumine is a specific stabilizer of transthyretin.
Croatian: Tafamidismeglumin je specifični stabilizator transtiretina.
English: If this leaflet is difficult to see or read or you would like it in a different format, please contact the Marketing Authorisation Holder's local office number that is provided in this leaflet.
Croatian: Ako se ova uputa slabo vidi ili ju je teško pročitati ili biste je voljeli dobiti u drugačijem obliku, obratite se na broj telefona lokalnog nositelja odobrenja koji se nalazi u ovoj uputi.
English: Summary of safety profile
Croatian: Sažetak profila sigurnosti
English: Vyndaqel % change relative to Placebo
Croatian: Vyndaqel % promjena u odnosu na placebo
English: No cases of acute overdose have been reported.
Croatian: Nije zabilježen niti jedan slučaj akutnog predoziranja.
English: This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG}.
English: Cmax(ss) and Cmin(ss) was 2.7 and 1.6 µg/ml, respectively.
Croatian: Cmax(ss) iznosio je 2,7 µg/ml, a Cmin(ss) 1,6 µg/ml.
English: Vyndaqel is therefore not used for children and adolescents.
Croatian: Vyndaqel se stoga ne primjenjuje u djece i adolescenata.
English: Studies in animals have shown developmental toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su razvojnu toksičnost (vidjeti dio 5.3).
English: Nonclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, fertility and early embryonic development, genotoxicity and carcinogenic potential.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, plodnosti i ranog embrionalnog razvoja, genotoksičnosti i kancerogenog potencijala.
English: • You should not take Vyndaqel if you are pregnant or breast-feeding.
Croatian: • Ne smijete uzimati Vyndaqel ako ste trudni ili dojite.
English: Physicians should monitor patients and continue to assess the need for other therapy, including the need for liver transplantation, as part of this standard of care.
Croatian: Liječnici trebaju nadzirati bolesnike i nastaviti s procjenom potrebe za drugom terapijom, uključujući potrebu za transplantacijom jetre, kao dio ove standardne njege.