FrancophonIA/ELRC3.0 huggingface dataset:
English: Halimatoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.
Croatian: AS-a kod odraslih, ali s objektivnim znakovima upale u obliku povišenog C-reaktivnog proteina (CRP) i/ili nalaza magnetne rezonance (MRI), u kojih nije postignut zadovoljavajući odgovor na nesteroidne protuupalne lijekove (NSAIL) ili koji ih ne podnose.
English: Vertigo and visual impairment may occur following administration of Halimatoz (see section 4.8).
Croatian: Nakon primjene lijeka Halimatoz mogu se pojaviti vrtoglavica i poremećaji vida (vidjeti dio 4.8).
English: If you take Halimatoz the risk of getting lymphoma, leukaemia, or other cancers may increase.
Croatian: Rizik obolijevanja od limfoma, leukemije ili drugih tumora može se povećati ako primjenjujete lijek Halimatoz.
English: The recommended dose of Halimatoz for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Croatian: U odraslih bolesnika preporučena početna doza lijeka Halimatoz je 80 mg supkutano, nakon čega slijedi 40 mg supkutano svaka dva tjedna, počevši jedan tjedan nakon početne doze.
English: Crohn's disease is an inflammatory disease of the gut.
Croatian: Crohnova bolest u odraslih i djece Crohnova bolest je upalna bolest crijeva.
English: Halimatoz 40 mg solution for injection in pre-filled pen adalimumab
Croatian: Halimatoz 40 mg otopina za injekciju u napunjenoj brizgalici adalimumab
English: • You might get infections more easily while you are receiving Halimatoz treatment.
Croatian: • Dok primate terapiju lijeka Halimatoz, možete biti podložniji infekcijama.
English: Halimatoz is supplied in a single-use clear type I glass syringe with a stainless steel needle with a needle guard with finger flange, rubber needle cap and plastic plunger rod, containing 0.8 ml of solution.
Croatian: I s iglom od nehrđajućeg čelika sa štitnikom za iglu sa hvatištem za prste, gumenim zatvaračem igle i plastičnim klipom, a sadrži 0,8 ml otopine.
English: Package leaflet: Information for the patient Halimatoz 40 mg solution for injection in pre-filled syringe adalimumab This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika Halimatoz 40 mg otopina za injekciju u napunjenoj štrcaljki adalimumab
English: Beyond 16 weeks, patients with inadequate response to Halimatoz 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week.
Croatian: U bolesnika u kojih nije postignut zadovoljavajući odgovor na Halimatoz u dozi od 40 mg svaki drugi tjedan nakon 16 tjedana, možda će biti korisno povećati doziranje na 40 mg lijeka svaki tjedan ili 80 mg svaki drugi tjedan.
English: Halimatoz is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen (SensoReady) with transparent window and label.
Croatian: Halimatoz se isporučuje u jednokratnoj, napunjenoj štrcaljki uloženoj u brizgalicu trokutastog oblika
English: Halimatoz 40 mg solution for injection in pre-filled pen:
Croatian: Halimatoz 40 mg otopina za injekciju u napunjenoj brizgalici:
English: The usual Halimatoz dose for adults with ulcerative colitis is 160 mg initially (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), then 80 mg (as two 40 mg injections) two weeks later, and then 40 mg every other week.
Croatian: Uobičajena početna doza lijeka Halimatoz za odrasle bolesnike s ulceroznim kolitisom je 160 mg (u obliku četiri injekcije od 40 mg u jednom danu ili dvije injekcije na dan tijekom dva uzastopna dana), nakon čega poslije dva tjedna slijedi doza od 80 mg (u obliku dvije injekcije od 40 mg u jednom danu).
English: Room spinning sensation (vertigo) and vision disturbances may occur after taking Halimatoz.
Croatian: Nakon uzimanja lijeka Halimatoz može se javiti osjećaj da se prostorija vrti (vrtoglavica) te smetnje vida.
English: Methotrexate should be continued during treatment with Halimatoz.
Croatian: Halimatoz treba nastaviti primjenu metotreksata.
English: The usual dose regimen is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg two weeks later.
Croatian: Uobičajena početna doza lijeka Halimatoz je 80 mg (u obliku dvije injekcije od 40 mg u jednom danu), nakon čega poslije dva tjedna slijedi doza od 40 mg.
English: Halimatoz dose for paediatric patients with uveitis Patient weight
Croatian: Tablica 5. Doza lijeka Halimatoz za pedijatrijske bolesnike s uveitisom
English: Long-term safety evaluations are ongoing.
Croatian: Procjene dugoročne sigurnosti su u tijeku.
English: The reasons for this are not fully known and are possibly related to the mechanism of action.
Croatian: Razlozi za to nisu potpuno poznati i možda su u vezi s mehanizmom djelovanja.
English: Do not vigorously shake or invert.
Croatian: Nemojte snažno tresti niti okretati.
English: Reconstituted and diluted solutions: Use immediately.
Croatian: Rekonstituirane i razrijeđene otopine: Upotrijebiti odmah.
English: Over time, there was no significant increase in the rate of serious infections.
Croatian: Tijekom vremena nije bilo značajnog porasta u stopi ozbiljnih infekcija.
English: If you feel dizzy, do not drive or use tools or machines.
Croatian: Ako osjećate omaglicu, nemojte voziti niti koristiti alate ili strojeve.
English: The safety and efficacy of vedolizumab in children aged 0 to 17 years old have not been established.
Croatian: Sigurnost i djelotvornost vedolizumaba u djece u dobi od 0 do 17 godina nisu još ustanovljene.
English: Exploratory analyses provide additional data on key subpopulations studied.
Croatian: Eksplorativne analize daju dodatne podatke o ključnim ispitivanim subpopulacijama.
English: What Entyvio is and what it is used for
Croatian: Što je Entyvio i za što se koristi
English: and CD8
Croatian: i CD8
English: Every 8 weeks
Croatian: Svakih 8 tjedana
English: Your doctor may decide to alter this treatment schedule depending on how well Entyvio works for you.
Croatian: Vaš liječnik može odlučiti promijeniti ovakav raspored liječenja ovisno o tome kako Entyvio kod Vas djeluje.
English: • if you have cancer, tell your doctor.
Croatian: • ako imate karcinom, recite svom liječniku.
English: If not fully dissolved after 20 minutes, allow another 10 minutes for dissolution.
Croatian: Ako se sadržaj ne otopi u cijelosti nakon 20 minuta, pričekajte još dodatnih 10 minuta.
English: Date of first authorisation: 22 May 2014 Date of latest renewal: 12 December 2018
Croatian: Datum posljednje obnove odobrenja: 12. prosinca 2018.
English: • night sweats
Croatian: • noćna znojenja
English: All patients should be observed continuously during each infusion.
Croatian: Sve bolesnike treba neprekidno nadzirati tijekom svake infuzije.
English: If you have Crohn's disease you will first be given other medicines.
Croatian: Ako imate Crohnovu bolest, prvo ćete dobiti druge lijekove.
English: Tell your doctor or nurse immediately when you first receive this medicine, during treatment, and between doses:
Croatian: Odmah obavijestite svog liječnika ili medicinsku sestru kada prvi put primite ovaj lijek, tijekom liječenja i između doza:
English: What you need to know before you are given Entyvio
Croatian: Što morate znati prije nego primite Entyvio
English: No individual Preferred Term reported as an IRR occurred at a rate above 1%.
Croatian: Nijedan individualni standardni pojam prijavljen kao RPI nije se dogodio u stopi većoj od 1%.
English: You should use adequate contraception during treatment and for at least 4.5 months after the last treatment.
Croatian: Morate koristiti učinkovitu kontracepciju tijekom liječenja i najmanje 4,5 mjeseca nakon zadnjeg liječenja.
English: • if you are allergic to vedolizumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na vedolizumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)
English: Entyvio is not recommended for use in children or adolescents (under 18 years of age) due to the lack of information regarding the use of this medicine in this age group.
Croatian: Entyvio se ne preporučuje za primjenu u djece i adolescenata (mlađih od 18 godina) zbog nedostatka podataka o primjeni ovog lijeka u toj dobnoj skupini.
English: The treatment interruption period in clinical trials extended up to one year.
Croatian: Razdoblje prekida liječenja u kliničkim ispitivanjima trajalo je do godine dana.
English: • Physician's Educational Material
Croatian: • Edukacijski materijal za liječnike
English: As noted in Table 4, although the primary endpoint was not met, exploratory analyses show that clinically meaningful results were observed.
Croatian: Kao što je navedeno u tablici 4, iako primarni ishod nije ostvaren, eksplorativne analize pokazuju da su uočeni klinički značajni rezultati.
English: If you have ulcerative colitis, you will first be given other medicines.
Croatian: Ako imate ulcerozni kolitis, prvo ćete dobiti druge lijekove.
English: Gently swirl the vial for at least 15 seconds.
Croatian: Lagano vrtite bočicu najmanje 15 sekundi.
English: If you forget or miss your Entyvio infusion
Croatian: Ako ste zaboravili ili propustite primiti Entyvio infuziju
English: • Your doctor will also give you a Patient Alert Card for you to keep with you at all times.
Croatian: • Vaš će Vam liječnik također dati Karticu s upozorenjima za bolesnika koju uvijek nosite sa sobom.
English: Administration of the influenza vaccine should be by injection in line with routine clinical practice.
Croatian: Cjepivo protiv gripe treba primijeniti injekcijom u skladu s rutinskom kliničkom praksom.
English: Some infections may become serious and possibly even life-threatening if left untreated.
Croatian: Neke infekcije mogu postati ozbiljne te moguće čak opasne po život ako se ne liječe.
English: ¶Durable clinical remission: Clinical remission at ≥ 80% of study visits including final visit (week 52)
Croatian: ¶Trajna klinička remisija: Klinička remisija kod ≥ 80% studijskih posjeta uključujući završni posjet (tjedan 52)
English: Induction of remission in Crohn's disease may take up to 14 weeks in some patients.
Croatian: Indukcija remisije kod Crohnove bolesti može u nekih bolesnika trajati do 14 tjedana.
English: Tell your doctor immediately if you notice any of the following:
Croatian: Razgovarajte sa svojim liječnikom odmah ako primijetite bilo što od sljedećeg:
English: Overall, results from the clinical program to date do not suggest an increased risk for malignancy with vedolizumab treatment; however, the number of malignancies was small and long-term exposure was limited.
Croatian: Ukupno gledano, rezultati kliničkog programa dosad ne ukazuju na povećani rizik zloćudnih bolesti uz liječenje vedolizumabom; međutim, broj zloćudnih bolesti bio je mali, a dugoročna izloženost ograničena.
English: Other live vaccines may be administered concurrently with vedolizumab only if the benefits clearly outweigh the risks.
Croatian: Druga živa cjepiva mogu se davati istovremeno s vedolizumabom samo ako koristi jasno nadmašuju rizike.
English: • blurred vision (loss of sharpness of eyesight)
Croatian: • zamućen vid (gubitak oštrine vida)
English: Enrolled patients have failed at least one conventional therapy,
Croatian: Uključeni bolesnici nisu odgovorili na barem jednu standardnu terapiju,
English: Most infusion related reactions were not serious and occurred during the infusion or within the first hour after infusion is completed.
Croatian: Većina reakcija povezanih s infuzijom nisu bile ozbiljne i dogodile su se tijekom infuzije ili unutar prvog sata nakon dovršetka infuzije.
English: Entyvio may affect the way you respond to a vaccination.
Croatian: Entyvio može utjecati na način kako reagirate na cjepivo.
English: If you have previously taken natalizumab (a medicine used to treat multiple sclerosis) or rituximab (a medicine used to treat certain types of cancer and rheumatoid arthritis), tell your doctor, who will decide if you can be given Entyvio.
Croatian: Ako ste prethodno uzimali natalizumab (lijek za liječenje multiple skleroze) ili rituksimab (lijek koji se koristi za liječenje određenih vrsta karcinoma i reumatoidnog artritisa), recite svom liječniku, koji će odlučiti smijete li primati Entyvio.
English: 1 Up to 30 minutes are allowed for reconstitution
Croatian: 1Za rekonstituiranje je dozvoljeno do 30 minuta.
English: If you do not respond well enough or are intolerant to these medicines, your doctor may give you Entyvio to reduce the signs and symptoms of your disease.
Croatian: Ako ne reagirate dovoljno dobro ili ako ne podnosite te lijekove, liječnik Vam može dati Entyvio kako bi se smanjili znakovi i simptomi
English: Population pharmacokinetic analyses indicate that the distribution volume of vedolizumab is approximately 5 litres.
Croatian: Analize populacijske farmakokinetike ukazuju da je volumen distribucije vedolizumaba približno 5 litara.
English: There was no clinically meaningful difference in clinical remission between treatment groups at these time points.
Croatian: Nije bilo klinički značajne razlike u kliničkoj remisiji između skupina u ovim vremenskim točkama.
English: Therefore, this medicine is not recommended for use during pregnancy unless you and your doctor decide that the benefit to you clearly outweighs the potential risk to yourself and your baby.
Croatian: Stoga se primjena ovog lijeka ne preporučuje tijekom trudnoće osim ako Vi i Vaš liječnik ne odlučite da korist od liječenja izričito nadilazi potencijalni rizik za Vas i Vaše dijete.
English: If PML is suspected, treatment with vedolizumab must be withheld; if confirmed, treatment must be permanently discontinued.
Croatian: Ako se sumnja na PML, potrebno je obustaviti liječenje vedolizumabom; u slučaju potvrde, liječenje se mora trajno prekinuti.
English: Caution should be exercised when considering the use of Entyvio in these patients.
Croatian: Potreban je oprez kad se razmatra uporaba lijeka Entyvio u ovih bolesnika.
English: These could occur during or after the infusion.
Croatian: Ti se znakovi mogu pojaviti tijekom ili nakon infuzije.
English: Therefore, the use of Entyvio in such patients is not recommended.
Croatian: Stoga se uporaba lijeka Entyvio u takvih bolesnika ne preporučuje.
English: 0 weeks
Croatian: 0 tjedana
English: Patients should be monitored during and after infusion (see section 4.4).
Croatian: Bolesnici moraju biti pod nadzorom tijekom i nakon infuzije (vidjeti dio 4.4).
English: uncommon (≥ 1/1,000 to < 1/100) and very rare (< 1/10,000).
Croatian: (≥1 /100 i < 1/10), manje često (≥ 1/1000 i < 1/100) i vrlo rijetko (< 1/10 000).
English: • wheezing or difficulty breathing
Croatian: • piskanje ili poteškoće u disanju
English: 6 weeks after Treatment 1
Croatian: 6 tjedana nakon liječenja 1
English: Instructions for reconstitution and infusion
Croatian: Upute za rekonstituciju i infuziju
English: For the first two infusions, they should also be observed for approximately 2 hours following completion of the infusion for signs and symptoms of acute hypersensitivity reactions.
Croatian: Prilikom prve dvije infuzije mora ih se također nadzirati približno 2 sata nakon završetka infuzije radi znakova i simptoma akutnih reakcija preosjetljivosti.
English: Some integrin antagonists and some systemic immunosuppressive agents have been associated with progressive multifocal leukoencephalopathy (PML), which is a rare and often fatal opportunistic infection caused by the John Cunningham (JC) virus.
Croatian: Neki antagonisti integrina i neki sistemski imunosupresivi povezani su s progresivnom multifokalnom leukoencefalopatijom (PML) koja je rijetka i često smrtonosna oportunistička infekcija uzrokovana virusom John Cunningham (JC).
English: • if you have an infection, or think you have an infection, if you develop chills, shivering, persistent cough or a high fever.
Croatian: • ako imate infekciju, ili mislite da imate infekciju, ako razvijete zimicu, drhtavicu, ustrajni kašalj ili povišenu temperaturu.
English: Further treatments
Croatian: Daljnja liječenja
English: Observed IRRs generally resolved with no or minimal intervention following the infusion.
Croatian: Uočene RPI općenito su se povukle bez intervencija ili uz minimalne intervencije nakon infuzije.
English: Other medicines and Entyvio Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su prikazane slijedom smanjenja ozbiljnosti.
English: Once reconstituted, the infusion solution should be used as soon as possible.
Croatian: Nakon rekonstitucije, otopinu za infuziju treba upotrijebiti čim je prije moguće.
English: The majority of IRRs were mild or moderate in intensity and < 1% resulted in discontinuation of study treatment.
Croatian: Većina RPI bilo je blagog do umjerenog intenziteta, a < 1% reakcija rezultiralo je prekidom ispitivanog liječenja.
English: 3 This period may include up to 12 hours at 20 °C-25 °C.
Croatian: 3To razdoblje može uključiti do 12 sati pri 20 °C-25 °C.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Entyvio therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Entyvio uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Pharmacotherapeutic group: immunosuppressants, selective immunosuppressants, ATC code: L04AA33
Croatian: Farmakoterapijska skupina: imunosupresivi, selektivni imunosupresivi, ATK oznaka: L04AA33.
English: The exact elimination route of vedolizumab is not known.
Croatian: Točan put eliminacije vedolizumaba nije poznat.
English: For more detailed information, see infusion and allergic reactions in section 4.
Croatian: Za više pojedinosti pogledajte infuzijske i alergijske reakcije u poglavlju 4.
English: Entyvio is administered as an intravenous infusion over 30 minutes.
Croatian: Entyvio se primjenjuje kao intravenska infuzija tijekom 30 minuta.
English: 2 weeks after Treatment 1
Croatian: 2 tjedna nakon liječenja 1
English: Long-term animal studies with vedolizumab to assess its carcinogenic potential have not been conducted because pharmacologically responsive models to monoclonal antibodies do not exist.
Croatian: Dugoročna ispitivanja vedolizumaba na životinjama za procjenu njegovog kancerogenog potencijala nisu provedena jer farmakološki modeli odgovora na monoklonska protutijela ne postoje.
English: • acne (pimples)
Croatian: • akne (bubuljice)
English: • moderately to severely active Crohn's disease.
Croatian: • umjereno do izrazito aktivne Crohnove bolesti.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for vedolizumab, the scientific conclusions of the CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za vedolizumab, znanstveni zaključci CHMP-a su sljedeći:
English: • if you are going to receive any vaccination or have recently had a vaccination.
Croatian: • ako ćete primiti cjepivo ili ste nedavno cijepljeni.
English: Starting at week 6, patients received 300 mg vedolizumab every eight or four weeks.
Croatian: Počevši od 6. tjedna, bolesnici su primali 300 mg vedolizumaba svakih osam ili četiri tjedna.
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Entyvio are provided with a physician pack containing the following:
Croatian: Nositelj odobrenja mora osigurati da, prije puštanja lijeka u promet, svi liječnici za koje se predviđa da će propisivati/upotrebljavati Entyvio dobiju paket informacija za liječnike koji sadrži sljedeće:
English: Given the known risk of PML development in patients with previous natalizumab exposure, physicians should normally wait 12 weeks after the last natalizumab dose prior to initiating Entyvio treatment.
Croatian: Uzevši u obzir poznati rizik od razvoja PML-a u bolesnika prethodno izloženih natalizumabu, liječnici trebaju u pravilu pričekati 12 tjedana nakon zadnje doze natalizumaba prije početka liječenja lijekom Entyvio.
English: Antibodies to vedolizumab may develop during vedolizumab treatment most of which are neutralising.
Croatian: Tijekom liječenja vedolizmabom mogu se razviti protutijela na vedolizumab, od kojih je većina neutralizirajuća.
English: Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake „EXP“.
English: It is to be reconstituted and further diluted prior to intravenous administration
Croatian: Mora se rekonstituirati i dodatno razrijediti prije intravenske primjene.
English: This leaflet is available in formats suitable for the blind or partially sighted patient and can be requested from respective local representative of the Marketing Authorisation Holder.
Croatian: Ova je uputa dostupna u formatima za slijepe i slabovidne osobe a može se zatražiti od lokalnog predstavnika nositelja odobrenja za stavljanje lijeka u promet.
English: Although no systemic immunosuppressive effect was noted in healthy subjects the effects on systemic immune system function in patients with inflammatory bowel disease is not known.
Croatian: Iako nije uočen sustavni imunosupresivni učinak u zdravih ispitanika, sistemski učinci na imunološki sustav bolesnika s upalnom bolešću crijeva nisu poznati.
English: There are no data on the secondary transmission of infection by live vaccines in patients receiving vedolizumab.
Croatian: Nema podataka o sekundarnom prijenosu infekcije živim cjepivima u bolesnika koji primaju vedolizumab.
English: Physicians should be aware of the potential increased risk of opportunistic infections or infections for which the gut is a defensive barrier (see section 4.8).
Croatian: Liječnici trebaju biti svjesni potencijalno povećanog rizika od oportunističkih infekcija ili infekcija za koje su crijeva obrambena barijera (vidjeti dio 4.8).
English: Immunomodulatory medicinal products may increase the risk of malignancy (see section 4.8).
Croatian: Imunomodulatorni lijekovi mogu povećati rizik od malignih bolesti (vidjeti dio 4.8).
English: in cerebrospinal fluid pre- and post-vedolizumab administration in healthy human volunteers.
Croatian: u cerebrospinalnoj tekućini prije i nakon primjene vedolizumaba kod zdravih ljudskih dobrovoljaca.
English: Based on plausible mechanism and available number of spontaneous reports of herpes zoster, the PRAC concluded that the product information should be updated with herpes zoster as a new adverse drug reaction with frequency uncommon.
Croatian: Na temelju vjerojatnog mehanizma djelovanja i određenog broja dostupnih spontanih prijava herpes zostera, PRAC je zaključio da se informacije o lijeku moraju ažurirati navođenjem herpes zostera kao nove nuspojave lijeka, s učestalošću „manje često“.
English: Vedolizumab did not affect CD4
Croatian: Vedolizumab nije utjecao na promet CD4
English: Solution should be clear or opalescent, colourless to light yellow and free of visible particulates.
Croatian: Otopina mora biti bistra ili opalescentna, bezbojna do svijetložuta i bez vidljivih čestica.
English: Administer the infusion solution over 30 minutes (see section 4.2).
Croatian: Otopinu za infuziju primijenite tijekom 30 minuta (vidjeti dio 4.2).