FrancophonIA/ELRC3.0 huggingface dataset:
English: The company will also carry out studies to confirm the long-term safety of the medicine.
Croatian: Tvrtka će provesti i ispitivanja kako bi potvrdila dugoročnu sigurnost lijeka.
English: It is usually used when other medicines or treatments have failed, in adults with the following diseases:
Croatian: Obično se koristi kad drugi lijekovi i liječenja nemaju uspjeha, kod odraslih sa sljedećim stanjima:
English: Some side effects, including infections, may be more common in children than in adults.
Croatian: Neke nuspojave, uključujući infekcije, mogu biti češće kod djece nego kod odraslih.
English: A risk management plan has been developed to ensure that Inflectra is used as safely as possible.
Croatian: Razvijen je plan upravljanja rizikom kako bi se osiguralo da se Inflectra koristi što je sigurnije moguće.
English: The full EPAR for Inflectra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za Inflectru može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Inflectra is usually given as 3 mg per kilogram body weight in rheumatoid arthritis, although the dose can be increased if necessary.
Croatian: Inflectra se obično primjenjuje u dozi od 3 mg po kilogramu tjelesne težine kod reumatoidnog artritisa, iako se doza može povećati ako je to potrebno.
English: How often the treatment is repeated depends on which disease is being treated, and on the patient's response to the medicine.
Croatian: Koliko često se liječenje ponavlja ovisi o bolesti koja se liječi i o odgovoru bolesnika na liječenje.
English: It is not intended to provide practical advice on how to use Inflectra.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja Inflectre.
English: All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards.
Croatian: Svi bolesnici se nadziru za bilo kakve reakcije tijekom infuzije i najmanje jedan do dva sata nakon infuzije.
English: The dose is 5 mg per kilogram for the other diseases.
Croatian: Preporučena doza za druge bolesti je 5 mg po kilogramu tjelesne težine.
English: To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Inflectra or the infusion time may be slowed down.
Croatian: Kako bi smanjili rizik od reakcija povezanih s infuzijom, bolesnicima se mogu dati drugi lijekovi prije ili tijekom liječenja lijekom Inflectra ili se brzina primjene infuzije može usporiti.
English: What is Inflectra and what is it used for?
Croatian: Što je Inflectra i za što se koristi?
English: Inflectra is produced by a method known as ‘recombinant DNA technology'.
Croatian: Inflectra se proizvodi metodom koja je poznata kao „tehnologija rekombinantne DNK”.
English: What measures are being taken to ensure the safe and effective use of Inflectra?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Inflectra?
English: For more information on biosimilar medicines, see the question-and-answer document here.
Croatian: Za više informacija o biološki sličnim lijekovima, pogledajte dokument s pitanjima i odgovorima ovdje.
English: This means that Inflectra is similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU) and that Inflectra and the reference medicine contain the same active substance.
Croatian: To znači da je lijek Inflectra sličan biološkom lijeku („referentni lijek”) koji je već odobren u Europskoj uniji (EU) i da Inflectra i referentni lijek sadrže istu djelatnu tvar.
English: The most common side effects with Inflectra (seen in more than 1 patient in 10) are viral infections (such as flu or cold sores), headache, upper respiratory-tract infection (colds), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusion-related reactions and pain.
Croatian: Najčešće nuspojave lijeka Inflectra (koje se mogu javiti u više od 1 na 10 osoba) su virusne infekcije (kao što su gripa ili plikovi), glavobolja, infekcija gornjih dišnih putova (prehlade), sinusitis (upala sinusa), mučnina (osjećaj slabosti), abdominalna bol (bol u trbuhu), reakcije povezane s infuzijom i bol.
English: By blocking TNF-alpha, infliximab improves the inflammation and other symptoms of the diseases.
Croatian: Blokirajući TNF-alpha, infliksimab umanjuje upalu i druge simptome bolesti.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Inflectra has been shown to have a comparable quality, safety and efficacy profile to Remicade.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučilo je da je, u skladu sa zahtjevima EU, lijek Inflectra pokazao kvalitetu, sigurnost i učinkovitost koja se može uspoređivati s lijekom Remicade.
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) in the body.
Croatian: Monoklonsko protutijelo je protutijelo (vrsta bjelančevine) koja je dizajnirana kako bi prepoznala i spojila se sa specifičnom strukturom (koja se zove antigen) u tijelu.
English: Inflectra is given as an infusion lasting one or two hours.
Croatian: Inflectra se primjenjuje u obliku infuzije koja traje jedan do dva sata.
English: After 30 weeks of treatment Inflectra was as effective as Remicade with around 60 % of patients responding to treatment with either medicine.
Croatian: Nakon 30 tjedana liječenja lijek Inflectra bio je učinkovit kao i Remicade s oko 60% ispitanika koji su odgovorili na liječenje s jednim od lijekova.
English: Inflectra was compared with Remicade in one main study involving 606 adult patients with rheumatoid arthritis.
Croatian: Lijek Inflectra uspoređivao se s lijekom Remicade u jednom glavnom ispitivanju koje je uključivalo 606 odraslih ispitanika s reumatoidnim artritisom.
English: Inflectra is used with methotrexate (a medicine that acts on the immune system);
Croatian: Inflectra se koristi uz metotreksat (lijek koji djeluje na imunološki sustav);
English: Other information about Inflectra
Croatian: Druge informacije o lijeku Inflectra
English: The European Commission granted a marketing authorisation valid throughout the European Union for Inflectra on 10 September 2013.
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za lijek Inflectra vrijedi na prostoru Europske unije od 10/09/2013.
English: In addition, the company that markets Inflectra will provide educational material to doctors who are expected to prescribe the medicine in adults and children including information on the safety of the medicine and an alert card to be given to patients.
Croatian: Nadalje, nositelj odobrenja za stavljanje u promet lijeka Inflectra daje edukativne materijale liječnicima za koje se očekuju da propisuju lijek kod odraslih i djece uključujući informacije o sigurnosti lijeka i karton za upozorenje koji se mora dati bolesnicima.
English: An additional study was also carried involving 250 patients with ankylosing spondylitis out to show that Inflectra produces levels of the active substance in the body that are comparable to the reference medicine, Remicade.
Croatian: Provedeno je dodatno ispitivanje uključujući 250 ispitanika s ankilozirajućim spondilitisom kako bi se pokazalo da lijek Inflectra proizvodi razine djelatne tvari u tijelu koje se mogu usporediti s onim referentnog lijeka Remicade.
English: This is a summary of the European public assessment report (EPAR) for Inflectra.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za Inflectru.
English: Inflectra 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: Lijek Inflectra ne smije se koristiti kod bolesnika s tuberkulozom, drugim ozbiljnim infekcijama ili umjerenim do teškim zatajenjem srca (nesposobnost srca da pumpa dovoljno krvi kroz tijelo).
English: The infliximab is made by cells that have received a gene (DNA), which makes them able to produce it.
Croatian: Infliksimab proizvode stanice koje su primile gen (DNK) koji im omogućuje da ga proizvode.
English: See the summary of product characteristics (also part of the EPAR) for full details.
Croatian: Pogledajte sažetak opisa svojstava lijeka (također dio EPAR-a) za sve pojedinosti.
English: It can only be obtained with a prescription and treatment should be started and supervised by a specialised doctor who has experience in the diagnosis and treatment of the diseases that Inflectra can be used to treat.
Croatian: Dostupan je samo na recept i liječenje mora započeti i nadzirati specijalist koji ima iskustava u dijagnosticiranju i liječenju bolesti za koje je lijek Inflectra namijenjen.
English: What are the risks associated with Inflectra?
Croatian: Koji su rizici povezani s lijekom Inflectra?
English: This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Inflectra is used to treat.
Croatian: Taj je glasnik uključen u uzrokovanje upale i pronađene su visoke razine kod oboljelih od onih bolesti za čije liječenje se upotrebljava Inflectra.
English: Why is Inflectra approved?
Croatian: Zašto je lijek Inflectra odobren?
English: The Committee recommended that Inflectra be approved for use in the EU.
Croatian: Povjerenstvo je preporučilo da se lijek Inflectra odobri za korištenje u Europskoj uniji.
English: How is Inflectra used?
Croatian: Kako se Inflectra koristi?
English: Therefore, the CHMP's view was that, as for Remicade, the benefit outweighs the identified risks.
Croatian: Stoga je stav CHMP-a da njegove koristi, kao i za lijek Remicade, nadmašuju s njim povezane rizike.
English: Patients who receive Inflectra must be given a special alert card that summarises the safety information about the medicine.
Croatian: Bolesnici koji primaju lijek Inflectra moraju dobiti poseban karton za upozorenje koji sažeto prikazuje sigurnosne informacije o lijeku.
English: For more information about treatment with Inflectra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Inflectra pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: • Crohn's disease (a disease causing inflammation of the digestive tract), when the disease is moderate to severe or fistulising (with the formation of fistulae, abnormal passageways between the gut and other organs);
Croatian: • Crohnova bolest (bolest koja uzrokuje upalu probavnog trakta), kad je bolest umjerena do teška ili fistulizirajuća (sa stvaranjem fistula, abnormalnih kanala između crijeva i drugih organa);
English: The reference medicine for Inflectra is Remicade.
Croatian: Referentni lijek za lijek Inflectra je Remicade.
English: ‘Inflectra is a ‘biosimilar' medicine.
Croatian: Inflectra je „biološki sličan” lijek.
English: Patients received either Inflectra or Remicade in addition to methotrexate for 30 weeks.
Croatian: Ispitanici su primali bilo lijek Inflectra, bilo Remicade kao dodatak uz metotreksat kroz 30 tjedana.
English: For practical information about using Inflectra, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju Inflectre bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: Infliximab has been designed to attach to a chemical messenger in the body called tumour necrosis factor-alpha (TNF-alpha).
Croatian: Infliksimab je dizajniran kako bi se spojio na kemijskog glasnika u tijelu koji se naziva čimbenik nekroze tumora alfa (eng.
English: Inflectra must not be used in patients who have experienced hypersensitivity (allergy) to infliximab in the past, or who are hypersensitive (allergic) to mouse proteins or any of the other ingredients of Inflectra.
Croatian: Inflectra se ne smije upotrebljavati kod bolesnika koji su ranije imali preosjetljivost (alergiju) na infliksimab ili koji su preosjetljivi (alergični) na bjelančevine miša ili bilo koji drugi sastojak lijeka Inflectra.
English: Inflectra was studied to show that it is comparable to the reference medicine, Remicade.
Croatian: Lijek Inflectra ispitivao se kako bi se pokazalo može li se uspoređivati s referentnim lijekom Remicade.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Inflectra, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za lijek Inflectra uključene su sigurnosne informacije uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: • rheumatoid arthritis (an immune-system disease causing inflammation of the joints).
Croatian: • reumatoidni artritis (bolest imunološkog sustava koja uzrokuje upalu zglobova).
English: Inflectra is an anti-inflammatory medicine that contains the active substance infliximab.
Croatian: Inflectra je protuupalni lijek koji sadrži djelatnu tvar infliksimab.
English: Inflectra is available as a powder to be made up into a solution for infusion (drip) into a vein.
Croatian: Inflectra je dostupna u obliku praška koji se priprema u otopinu za infuziju (drip) za venu.
English: What benefits of Inflectra have been shown in studies?
Croatian: Koje koristi lijeka Inflectra su dokazane u ispitivanjima?
English: The active substance in Inflectra, infliximab, is a monoclonal antibody.
Croatian: Djelatna tvar u lijeku Inflectra je infliksimab, monoklonsko protutijelo.
English: Inflectra is also used in patients aged between six and 17 years with severe, active Crohn's disease or severely active ulcerative colitis, when they have not responded to or cannot take other medicines or treatments.
Croatian: • psorijaza (bolest koja uzrokuje crvene ljuskave mrljaste naslage na koži); Inflectra se također koristi kod bolesnika u dobi između šest i 17 godina s teškom aktivnom Crohnovom bolešću ili teškim ulceroznim kolitisom, kad na njih nisu djelovali prethodni lijekovi ili liječenja ili kada ih ne mogu primati.
English: • ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine);
Croatian: • ankilozirajući spondilitis (bolest koja uzrokuje upalu i bol u zglobovima kralježnice);
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints);
Croatian: • psorijatični artritis (bolest koja uzrokuje crvene ljuskave mrljaste naslage na koži i upalu zglobova);
English: How does Inflectra work?
Croatian: Kako Inflectra djeluje?
English: For the full list of all side effects reported with Inflectra, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s lijekom Inflectra potražite u uputi o lijeku.
English: • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
Croatian: • ulcerozni kolitis (bolest koja uzrokuje upalu i vrijedove sluznice crijeva);
English: At any time:
Croatian: U bilo kojem trenutku:
English: Urgent treatment may be necessary.
Croatian: Može Vam biti potrebno hitno liječenje.
English: • Grade ≤1;
Croatian: • stupanj ≤ 1;
English: The next prescribed dose should be taken at the usual time.
Croatian: Sljedeću propisanu dozu treba uzeti u uobičajeno vrijeme.
English: Do not stop taking IBRANCE unless your doctor tells you to.
Croatian: Nemojte prestati uzimati IBRANCE osim ako Vam liječnik to nije rekao.
English: Swallow the capsule whole with a glass of water.
Croatian: Progutajte cijelu kapsulu s čašom vode.
English: Patients should be encouraged to take their dose at approximately the same time each day.
Croatian: Bolesnice treba ohrabriti da uzimaju svoju dozu u približno isto vrijeme svaki dan.
English: Discuss contraception with your doctor if there is any possibility that you or your partner may become pregnant.
Croatian: Raspravite o kontracepciji s Vašim liječnikom ako postoji ikakva mogućnost da biste Vi ili Vaša partnerica mogli ostati trudni.
English: Do not take a double dose to make up for the forgotten capsules.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljene kapsule.
English: Withhold until symptoms resolve to:
Croatian: Prekinuti dok se simptomi ne povuku na:
English: Approximately 20% of patients were pre/perimenopausal.
Croatian: Približno 20% bolesnica bile su u pre/perimenopauzi.
English: Day 15 of first 2 cycles:
Croatian: 15. dan prva dva ciklusa:
English: Coadministration should only be considered after careful evaluation of the potential benefits and risks.
Croatian: Istodobna primjena smije se uzeti u obzir samo nakon pažljive procjene mogućih koristi i rizika.
English: The majority of the material was excreted as metabolites.
Croatian: Većina materijala izlučena je kao metaboliti.
English: Your doctor will tell you how many capsules of IBRANCE to take.
Croatian: Vaš liječnik će Vam reći koliko kapsula lijeka IBRANCE trebate uzeti.
English: In vitro studies with transporters
Croatian: In vitro ispitivanja s transporterima
English: Do not open the capsules.
Croatian: Nemojte otvarati kapsule.
English: Take the carton and this leaflet, so that the doctor knows what you have been taking.
Croatian: Uzmite kutiju i ovu uputu tako da liječnik zna što uzimate.
English: IBRANCE with food and drink
Croatian: IBRANCE s hranom i pićem
English: Age, gender, and body weight
Croatian: Dob, spol i tjelesna težina
English: IBRANCE is not to be used in children or adolescents (under 18 years of age).
Croatian: IBRANCE se ne smije koristiti u djece ili adolescenata (mlađih od 18 godina).
English: Date of first authorisation: 09 November 2016
Croatian: Datum prvog odobrenja: 09. studenog 2016.
English: *If further dose reduction below 75 mg/day is required, discontinue the treatment.
Croatian: *Ako je potrebno daljnje smanjenje doze ispod 75 mg/dan, prekinite liječenje.
English: IBRANCE may reduce the number of your white blood cells and weaken your immune system.
Croatian: IBRANCE može smanjiti broj Vaših bijelih krvnih stanica i oslabiti Vaš imunitet.
English: If you feel unusually tired, take special care when driving or using machines.
Croatian: Ako se osjećate neobično umorni, budite posebno oprezni kod upravljanja vozilima i rukovanja strojevima.
English: However, no clinical data have been obtained on fertility in humans.
Croatian: Međutim, nisu dobiveni klinički podaci o plodnosti u ljudi.
English: If you have taken too much IBRANCE, see a doctor or go to a hospital immediately.
Croatian: Ako ste uzeli previše lijeka IBRANCE, odmah posjetite liječnika ili otiđite u bolnicu.
English: What IBRANCE is and what it is used for
Croatian: Što je IBRANCE i za što se koristi
English: Other medicines and IBRANCE
Croatian: Drugi lijekovi i IBRANCE
English: Talk to your doctor, pharmacist or nurse before taking IBRANCE.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete IBRANCE.
English: Physicians should inform patients to promptly report any episodes of fever.
Croatian: Liječnici moraju informirati bolesnice da odmah prijave bilo kakve epizode vrućice.
English: Dose modification of IBRANCE is recommended based on individual safety and tolerability.
Croatian: Prilagodbe doze Promjena doze lijeka IBRANCE preporučuje se na temelju pojedinačne sigurnosti i podnošljivosti.
English: When recovered to Grade ≤2, start the next cycle at the same dose.
Croatian: Kad se oporavi na stupanj ≤ 2, započnite sa sljedećim ciklusom u istoj dozi.
English: Grade 1 or 2
Croatian: Stupanj 1 ili 2
English: Do not take IBRANCE:
Croatian: Nemojte uzimati IBRANCE:
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: What IBRANCE is and what it is used for 2.
Croatian: Što je IBRANCE i za što se koristi 2.
English: Do not chew or crush the capsules.
Croatian: Nemojte žvakati ili lomiti kapsule.
English: If the patient vomits or misses a dose, an additional dose should not be taken that day.
Croatian: Ako bolesnica povraća ili propusti dozu, dodatna doza ne smije se uzeti isti dan.
English: It may therefore have risk of foetal harm if used during pregnancy.
Croatian: Stoga može predstavljati rizik od oštećenja fetusa ako se koristi tijekom trudnoće.
English: No studies have been conducted in humans or animals to assess the effect of palbociclib on milk production, its presence in breast milk, or its effects on the breast-fed child.
Croatian: Nisu provedena ispitivanja u ljudi ili na životinjama kako bi se procijenio učinak palbocikliba na stvaranje mlijeka, njegovu prisutnost u mlijeku ili njegove učinke na dojeno dijete.
English: Blocking these proteins can slow down growth of cancer cells and delay the progression of your cancer.
Croatian: Blokada tih bjelančevina može usporiti rast stanica raka i odgoditi napredovanje Vašeg raka.
English: PVC/PCTFE/PVC/Al blister strip containing 7 hard capsules (one capsule per cell).
Croatian: PVC/PCTFE/PVC/Al blister koji sadrži 7 tvrdih kapsula (jedna kapsula po svakom polju blistera).
English: Tell your doctor, pharmacist or nurse if you experience signs or symptoms of an infection, such as chills or fever.
Croatian: Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako iskusite znakove ili simptome infekcije, kao što su zimica ili vrućica.
English: If you experience certain side effects while you are taking IBRANCE (see section 4 “Possible side effects”), your doctor may lower your dose or stop treatment, either temporarily or permanently.
Croatian: Ako primjetite određene nuspojave dok uzimate IBRANCE (vidjeti dio 4 „Moguće nuspojave“), Vaš liječnik može smanjiti Vašu dozu ili prekinuti liječenje, bilo privremeno bilo trajno.
English: If Grade 4 on Day 22, see Grade 4 dose modification guidelines below.
Croatian: Ako se 22. dana ustanovi stupanj 4, vidjeti niže navedene smjernice o promjeni doze za stupanj 4.
English: At the data cutoff date of 26-February-2016, the study met its primary objective of improving PFS.
Croatian: Na zaključni datum prikupljanja podataka, 26. veljače 2016. ispitivanje je ispunilo svoj primarni cilj u poboljšavanju PFS-a.
English: After a median follow-up time of 45 months, the final OS analysis was performed based on 310 events (60% of randomised patients).
Croatian: Nakon medijana praćenja koji je iznosio 45 mjeseci provedena je konačna analiza OS-a na temelju 310 događaja (60 % randomiziranih bolesnica).
English: You will have regular blood tests during treatment to check whether IBRANCE affects your blood cells (white blood cells, red blood cells, and platelets).
Croatian: Tijekom liječenja redovito će Vam se raditi krvne pretrage kako bi se provjerilo utječe li IBRANCE na Vaše krvne stanice (bijele krvne stanice, crvene krvne stanice i krvne pločice).
English: • difficulty breathing or shortness of breath
Croatian: • otežano disanje ili nedostatak zraka
English: Frequency categories are defined as: very common (≥1/10), common (≥1/100 to <1/10), and uncommon (≥1/1,000 to
Croatian: Kategorije učestalosti definirane su kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10) i manje često (≥ 1/1000 i
English: If you take more IBRANCE than you should
Croatian: Ako uzmete više lijeka IBRANCE nego što ste trebali
English: The treatment with IBRANCE should be continued as long as the patient is deriving clinical benefit from therapy or until unacceptable toxicity occurs.
Croatian: Liječenje lijekom IBRANCE treba nastaviti sve dok bolesnica ostvaruje kliničku korist od terapije ili dok se ne pojavi neprihvatljiva toksičnost.