FrancophonIA/ELRC3.0 huggingface dataset:
English: The usual AMGEVITA 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) followed by 80 mg (as two 40 mg injections in one day) two weeks later, then 40 mg every other week.
Croatian: Uobičajena početna doza lijeka AMGEVITA za odrasle bolesnike s ulceroznim kolitisom je 160 mg (4 injekcije od 40 mg u jednom danu ili 2 injekcije od 40 mg na dan u dva uzastopna dana), nakon čega poslije dva tjedna slijedi doza od 80 mg (u obliku dvije injekcije od 40 mg u jednom danu).
English: EU/1/16/1164/008 - 4 pack
Croatian: EU/1/16/1164/008 4 pakiranja
English: Adolescent hidradenitis suppurativa (from 12 years of age, weighing at least 30 kg) There are no clinical trials with adalimumab in adolescent patients with HS.
Croatian: Adolescentni gnojni hidradenitis (u dobi od 12 i više godina, tjelesne težine najmanje 30 kg)
English: c Ankylosing Spondylitis Disease Activity Score d Partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Croatian: Ankylosing Spondylitis Disease Activity Score) d Djelomično pogoršanje definirano kao ASDAS ≥ 1,3 ali < 2,1 kod 2 uzasopne posjete ***, ** Statistički značajno kod p < 0,001 odnosno < 0,01 za sve usporedbe između adalimumaba i placeba
English: Discard the used syringe and the needle cap.
Croatian: Bacite iskorištenu štrcaljku i zatvarač igle.
English: Using your AMGEVITA pre-filled pen
Croatian: Primjena AMGEVITA napunjene brizgalice
English: AMGEVITA Dose for Paediatric Patients with Uveitis Patient Weight
Croatian: Tablica 5. Doza lijeka AMGEVITA za pedijatrijske bolesnike s uveitisom Tjelesna težina bolesnika
English: Syringe barrel
Croatian: pvrijednosta pvrijednostb pvrijednostc
English: NAME OF THE MEDICINAL PRODUCT AMGEVITA 20 mg solution for injection in pre-filled syringe.
Croatian: AMGEVITA 20 mg otopina za injekciju u napunjenoj štrcaljki.
English: Adalimumab 0.8 mg/kg eow N = 38
Croatian: Adalimumab 0,8 mg/kg svaki drugi tjedan N = 38
English: Low dose 20/10 mg eow
Croatian: Niska doza 20/10 mg svaki drugi tjedan
English: Age Group
Croatian: Dobne skupine
English: The usual dose regimen for Crohn's disease is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg every other week two weeks later.
Croatian: Uobičajena početna doza lijeka je 80 mg (u obliku dvije injekcije od 40 mg u jednom danu), nakon čega poslije dva tjedna slijedi doza od 40 mg svaki drugi tjedan.
English: Step 2: Get ready E. Pull the needle cap straight out and away from your body when you are ready to inject.
Croatian: Povucite zatvarač igle ravno i dalje od Vašeg tijela kada ste spremni za injiciranje.
English: NAME OF THE MEDICINAL PRODUCT AMGEVITA 40 mg solution for injection in pre-filled syringe adalimumab
Croatian: AMGEVITA 40 mg otopina za injekciju u napunjenoj štrcaljki adalimumab
English: It is recommended that children,
Croatian: I DOHVATA DJECE
English: Gastroesophageal reflux disease, Sicca syndrome
Croatian: Ispitivanje kod Crohnove bolesti u djece PCDAI klinička remisija i odgovori
English: G. Hold the pinch.
Croatian: Držite nabor kože.
English: • bruising;
Croatian: • tjeskoba,
English: AMGEVITA therapy should not be continued in patients failing to respond within this time period.
Croatian: U bolesnika u kojih u ovom razdoblju ne bude odgovora, liječenje lijekom AMGEVITA ne treba nastaviti.
English: Very common Leukopenia (including neutropenia and agranulocytosis), Anaemia
Croatian: vrlo često leukopenija (uključujući neutropeniju i agranulocitozu), anemija često leukocitoza, trombocitopenija manje često idiopatska trombocitopenična purpura rijetko pancitopenija
English: Double blind 32 weeks Adalimumab /
Croatian: Pedijatrijski odgovor ACR 30 (n/N) Ishodi za djelotvornost Dvostruko slijepa - 32 tjedna
English: In some cases, serious complications have occurred.
Croatian: U nekim slučajevima došlo je i do ozbiljnih komplikacija.
English: This may also help to delay future worsening of your MS.
Croatian: To Vam također može pomoći u odgađanju budućeg pogoršanja MS-a.
English: Your doctor may reduce your dose.
Croatian: Liječnik Vam može smanjiti dozu.
English: Take this starting dose for the first 7 days, then take the regular dose.
Croatian: Početnu dozu uzimajte prvih 7 dana, a zatim uzimajte redovnu dozu.
English: If you take more Tecfidera than you should
Croatian: Ako uzmete više Tecfidere nego što ste trebali
English: Do not use Tecfidera if you are pregnant unless you have discussed this with your doctor.
Croatian: Ne uzimajte Tecfideru ako ste trudni osim ako ste o tome razgovarali sa svojim liječnikom.
English: You may experience side effects similar to those described below in section 4.
Croatian: Možda ćete doživjeti nuspojave slične onima opisanim ispod u dijelu 4.
English: These symptoms may disappear completely when the relapse is over, but some problems may remain.
Croatian: Ovi simptomi mogu u potpunosti nestati jednom kad je relaps prošao, ali neki problemi mogu i ostati.
English: The need for further MRI scanning should be considered in accordance with national and local recommendations.
Croatian: Potrebu za daljnjim pregledima MR-om treba uzeti u obzir u skladu s nacionalnim i lokalnim preporukama.
English: Blood/laboratory tests
Croatian: Krvni/laboratorijski testovi
English: These events were not life-threatening, but led to hospitalisation.
Croatian: Ti događaji nisu bili opasni po život, ali je zbog njih bila potrebna hospitalizacija.
English: DK - 3400 Hillerød Denmark
Croatian: DK - 3400 Hillerød Danska
English: Glatiramer acetate
Croatian: Glatiramer acetat
English: Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.8, 5.1 i 5.2, međutim nije moguće dati preporuku o doziranju.
English: Tecfidera with alcohol
Croatian: Tecfidera s alkoholom
English: The capsule should be swallowed whole.
Croatian: Kapsule se moraju progutati cijele.
English: This leaflet was last revised in {MM YYYY}.
Croatian: Ova uputa je zadnji puta revidirana u {MM GGGG}.
English: These events may occur at any time during treatment.
Croatian: Ovi se događaji mogu pojaviti u bilo kojem trenutku tijekom liječenja.
English: Sun as a symbol Moon as a symbol
Croatian: Simbol sunca Simbol mjeseca
English: Subjects with progressive forms of MS were not included in these studies.
Croatian: Ispitanici s progresivnim oblikom MS nisu bili uključeni u ova ispitivanja.
English: Mean values for both parameters remained within normal range.
Croatian: Srednje vrijednosti za oba parametra ostale su u normalnom rasponu.
English: The clinical implications of these changes are unknown.
Croatian: Nisu poznate kliničke implikacije tih promjena.
English: The Tmax of monomethyl fumarate is 2 to 2.5 hours.
Croatian: Tmax monometilfumarata je 2 do 2,5 sati.
English: Other medicines and Tecfidera
Croatian: Drugi lijekovi i Tecfidera
English: There were no effects on fertility in the F1 offspring.
Croatian: Nije bilo utjecaja na plodnost u F1 potomstvu.
English: This could cause inflammation of the stomach (gastritis), especially in people already prone to gastritis.
Croatian: To može uzrokovati upalu želuca (gastritis), naročito u ljudi koji su već skloni gastritisu.
English: PML is an opportunistic infection caused by John-Cunningham virus (JCV), which may be fatal or result in severe disability.
Croatian: PML je oportunistička infekcija uzrokovana John-Cunningham virusom (JCV), koja može biti smrtonosna ili uzrokovati tešku invalidnost.
English: Do not reduce your dose unless your doctor tells you to.
Croatian: Ne smanjujte dozu ukoliko Vam liječnik ne kaže da je smanjite.
English: The safety and efficacy of Tecfidera in children and adolescents aged 10 to 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost Tecfidere u djece i adolescenata u dobi od 10 do 18 godina nisu još ustanovljene.
English: If your number of white blood cells decreases during treatment, your doctor may consider interrupting your treatment
Croatian: Ukoliko Vam se broj bijelih krvnih stanica smanjuje tijekom liječenja, liječnik može razmotriti prekidanje Vašeg liječenja.
English: - if you are allergic to dimethyl fumarate or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na dimetilfumarat ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Pharmacokinetics in special patient groups
Croatian: Farmakokinetički odnosi u posebnim skupinama bolesnika
English: Relapsing-remitting MS is characterised by repeated attacks (relapses) of nervous system symptoms.
Croatian: Relapsno-remitirajuća MS je karakterizirana ponavljanim napadima (relapsima) simptoma živčanog sustava.
English: PML can only occur in the presence of a JCV infection.
Croatian: PML se može pojaviti samo u prisutnosti JCV infekcije.
English: However, these changes did not affect fertility or the number of viable fetuses produced.
Croatian: Međutim, ove promjene ne utječu na plodnost ili broj začetih vijabilnih fetusa.
English: Swallow each capsule whole, with some water.
Croatian: Progutajte svaku kapsulu cijelu s vodom.
English: The benefit of breast-feeding for the child and the benefit of therapy for the woman should be taken into account.
Croatian: Mora se uzeti u obzir korist dojenja za dijete i korist terapije za ženu.
English: Date of first authorisation: 30 January 2014 Date of latest renewal: 20 September 2018
Croatian: Datum posljednje obnove odobrenja: 20. rujna 2018
English: The frequency of severe allergic reactions cannot be estimated from the available data (not known).
Croatian: Učestalost teških alergijskih reakcija ne može se procijeniti iz dostupnih podataka (nepoznato).
English: Herpes zoster infections
Croatian: Herpes zoster infekcije
English: Lymphocyte counts should be followed until recovery.
Croatian: Broj limfocita treba pratiti do oporavka.
English: Your doctor will help you decide whether you should stop breastfeeding, or stop using Tecfidera.
Croatian: Liječnik će Vam pomoći odlučiti trebate li prestati dojiti ili prestati koristiti Tecfideru.
English: Treatment should not be restarted (see section 4.8).
Croatian: Ne smije se ponovno započeti s liječenjem (vidjeti dio 4.8).
English: Tecfidera can generally be started immediately after discontinuation of interferon or glatiramer acetate.
Croatian: Tecfidera se općenito može početi primjenjivati odmah nakon prekida primjene interferona ili glatirameracetata.
English: Herpes zoster1
Croatian: nepoznato herpes zoster1
English: A complete blood count is recommended prior to initiating Tecfidera and regularly during treatment (see Blood/laboratory tests above).
Croatian: Preporučuje se provesti kompletnu krvnu sliku prije početka primjene Tecfidere i redovito tijekom liječenja (vidjeti Krvni/laboratorijski testovi u tekstu iznad).
English: Talk to your doctor about how to manage these side effects.
Croatian: Razgovarajte sa svojim liječnikom kako liječiti ove nuspojave.
English: Reactions generally occur after the first dose, but may also occur at any time during treatment, and may be serious and life threatening.
Croatian: Te reakcije uglavnom nastaju nakon prve doze, ali se također mogu pojaviti u bilo kojem trenutku tijekom liječenja te biti ozbiljne i opasne po život.
English: You may take the missed dose if you leave at least 4 hours between the doses.
Croatian: Možete uzeti zaboravljenu dozu ako prođe najmanje 4 sata između doza.
English: Contents of the pack and other information What Tecfidera contains
Croatian: Sadržaj pakiranja i druge informacije Što Tecfidera sadrži
English: Reduced white blood cells could mean your body is less able to fight an infection.
Croatian: Smanjenje razine bijelih krvnih stanica može značiti da Vaše tijelo ima manju sposobnost da se bori protiv infekcije.
English: Tecfidera should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the foetus.
Croatian: Tecfidera se smije primijeniti za vrijeme trudnoće samo ako je potreba jasna i ako potencijalna korist opravdava potencijalni rizik za fetus.
English: MS is a long-term condition that affects the central nervous system (CNS), including the brain and the spinal cord.
Croatian: MS je dugotrajno stanje koje utječe na središnji živčani sustav (SŽS), uključujući mozak i leđnu moždinu.
English: Your doctor will test these periodically during treatment.
Croatian: Liječnik će Vam povremeno provoditi ove pretrage tijekom liječenja.
English: What you need to know before you take Tecfidera Do not take Tecfidera:
Croatian: Što morate znati prije nego počnete uzimati Tecfideru Nemojte uzimati Tecfideru:
English: Pharmacokinetic data were obtained in subjects with multiple sclerosis and healthy volunteers.
Croatian: Farmakokinetički podaci su dobiveni u ispitanika s multiplom sklerozom i u zdravih dobrovoljaca.
English: Take Tecfidera with food - it may help to reduce some of the very common side effects (listed in section 4).
Croatian: Uzimajte Tecfideru s hranom - može pomoći smanjiti neke vrlo česte nuspojave (navedene u dijelu 4).
English: As Tecfidera gastro-resistant hard capsules contain microtablets, which are protected by an enteric coating, absorption does not commence until they leave the stomach (generally less than 1 hour).
Croatian: Budući da Tecfidera želučanootporne tvrde kapsule sadrže mikrotablete koje su zaštićene acidorezistentnom ovojnicom, apsorpcija ne započinje sve dok kapsule ne napuste želudac (općenito manje od 1 sata).
English: During treatment with Tecfidera, simultaneous use of other fumaric acid derivatives (topical or systemic) should be avoided.
Croatian: Tijekom liječenja s Tecfiderom treba izbjegavati istodobnu uporabu drugih derivata fumaratne kiseline (topikalnu ili sistemsku).
English: Approximately 1,056 patients have received more than 2 years of treatment with Tecfidera.
Croatian: Otprilike 1056 bolesnika primalo je više od 2 godine liječenje Tecfiderom.
English: Otherwise wait until your next planned dose.
Croatian: U suprotnom, pričekajte na sljedeću raspoređenu dozu.
English: Based on the mode of action of the active substance there are no theoretical reasons for any requirement for dose adjustments in the elderly.
Croatian: Prema načinu djelovanja djelatne tvari nema teorijskih razloga za prilagodbu doze u starijih osoba.
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, ATC code: L04AX07
Croatian: Farmakoterapijska skupina: Antineoplastici i imunomodulatori, ATK oznaka: L04AX07 Mehanizam djelovanja
English: then this may represent a severe allergic reaction (anaphylaxis)
Croatian: onda to može biti teška alergijska reakcija (anafilaksija).
English: Having a low white blood cell count for a long period of time can increase your risk of infection, including a risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML).
Croatian: Nizak broj bijelih krvnih stanica tijekom dugog vremenskog razdoblja može povećati Vaš rizik od infekcije, uključujući i rizik od rijetke infekcije mozga nazvane progresivna multifokalna leukoencefalopatija (PML).
English: The safety of Tecfidera in paediatric patients with multiple sclerosis below the age of 18 has not yet been established.
Croatian: Sigurnost Tecfidere u pedijatrijskih bolesnika s multiplom sklerozom mlađih od 18 godina nije još ustanovljena.
English: Before you start Tecfidera, your doctor will do a blood test to count the number of your white blood cells and will check that your kidneys and liver are working properly.
Croatian: Prije nego što počnete uzimati Tecfideru, liječnik će Vam raditi krvne pretrage kako bi provjerio broj bijelih krvnih stanica, te će provjeriti da Vam bubrezi i jetra rade ispravno.
English: There are no known therapeutic interventions to enhance elimination of Tecfidera nor is there a known antidote.
Croatian: Nema poznatih terapijskih intervencija koje bi pojačale eliminaciju Tecfidere, niti ima poznatog antidota.
English: After starting therapy, complete blood counts, including lymphocytes, must be performed every 3 months.
Croatian: Nakon početka terapije, kompletna krvna slika, uključujući limfocite, mora se provesti svaka 3 mjeseca.
English: A positive immune response defined as a ≥4-fold increase in antibody titer to the three vaccines, was achieved by fewer subjects in both treatment groups.
Croatian: Pozitivan imunosni odgovor definiran kao povećanje titra protutijela za ≥4 puta na ta tri cjepiva postigao je manji broj bolesnika u obje terapijske skupine.
English: The lower offspring body weight was considered secondary to maternal toxicity.
Croatian: Manja tjelesna težina potomstva smatrala se posljedicom toksičnosti za majku.
English: In the event of overdose, it is recommended that symptomatic supportive treatment be initiated as clinically indicated.
Croatian: U slučaju predoziranja, preporuča se započeti suportivno liječenje simptoma kako je klinički indicirano.
English: The symptoms described in these cases were consistent with the known adverse reaction profile of Tecfidera.
Croatian: Simptomi opisani u tim slučajevima bili su u skladu s poznatim profilom nuspojava Tecfidere.
English: It should also be noted that a negative anti JCV antibody test (in the presence of normal lymphocyte counts) does not preclude the possibility of subsequent JCV infection.
Croatian: Također, treba napomenuti da negativan test na anti-JCV protutijela (u prisustvu normalnog broja limfocita) ne isključuje mogućnost naknadne JCV infekcije.
English: The pharmacokinetics in patients aged 65 and over has not been studied.
Croatian: Farmakokinetika u bolesnika starih 65 i više godina nije ispitivana.
English: Live vaccines might carry an increased risk of clinical infection and should not be given to patients treated with Tecfidera unless, in exceptional cases, this potential risk is considered to be outweighed by the risk to the individual of not vaccinating.
Croatian: Živa cjepiva mogu predstavljati povećan rizik od kliničke infekcije i ne smiju se dati bolesnicima liječenim Tecfiderom, osim u iznimnim slučajevima, kada se smatra da je ovaj potencijalni rizik manji od rizika za pojedinca ako ga se ne cijepi.
English: Clinical studies of Tecfidera had limited exposure to patients aged 55 years and above, and did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients (see section 5.2).
Croatian: U kliničkim ispitivanjima s Tecfiderom bila je ograničena izloženost bolesnika u dobi od 55 godina i više i nije bio uključen dovoljan broj bolesnika u dobi od 65 godina i više kako bi se utvrdilo reagiraju li oni drugačije od mlađih bolesnika (vidjeti dio 5.2).
English: After 7 days, the dose should be increased to the recommended maintenance dose of 240 mg twice a day (see section 4.4).
Croatian: Nakon 7 dana, dozu je potrebno povisiti na preporučenu dozu održavanja od 240 mg dvaput na dan (vidjeti dio 4.4).
English: The relevance of these findings to humans is not known.
Croatian: Nije poznata relevantnost ovih nalaza za ljude.
English: Consumption of large quantities of strong alcoholic drinks (more than 30% alcohol by volume) should be avoided within an hour of taking Tecfidera, as alcohol may lead to increased frequency of gastrointestinal adverse reactions.
Croatian: Potrebno je izbjegavati konzumiranje velikih količina jakih alkoholnih pića (više od 30% alkohola po volumenu) unutar jednog sata od uzimanja Tecfidere, jer alkohol može dovesti do povećane učestalosti gastrointestinalnih nuspojava.
English: Data from preclinical studies do not suggest that dimethyl fumarate would be associated with an increased risk of reduced fertility (see section 5.3).
Croatian: Podaci iz pretkliničkih ispitivanja ne upućuju na to da bi dimetilfumarat bio povezan s povećanim rizikom od smanjenja plodnosti (vidjeti dio 5.3).
English: Based on the results of Analysis of Variance (ANOVA), body weight is the main covariate of exposure (by Cmax and AUC) in RRMS subjects, but did not affect safety and efficacy measures evaluated in the clinical studies.
Croatian: Na temelju rezultata analize varijance (ANOVA), tjelesna težina je glavna kovarijata izloženosti (prema Cmax i AUC-u) u ispitanika s RRMS-om, ali ne utječe na mjere sigurnosti i djelotvornosti procijenjene u kliničkim ispitivanjima.
English: If you forget to take Tecfidera
Croatian: Ako ste zaboravili uzeti Tecfideru
English: Upon recovery and in the absence of alternative treatment options, decisions about whether or not to restart Tecfidera after treatment discontinuation should be based on clinical judgement.
Croatian: Nakon oporavka i u nedostatku zamjenskih opcija liječenja, odluku o tome da li da se ponovno započne liječenje Tecfiderom nakon prekida terapije treba temeljiti na kliničkoj procjeni.
English: Do not divide, crush, dissolve, suck or chew the capsule as this may increase some side effects.
Croatian: Kapsulu ne smijete razdijeliti, zdrobiti, otopiti, sisati ili žvakati jer to može povećati neke nuspojave.
English: If treatment is continued despite a persistent lymphocyte count < 0.5x109/L, enhanced vigilance is recommended (see also subsection on PML).
Croatian: Ako se liječenje nastavlja unatoč trajnom broju limfocita <0,5x109/l, preporučuje se pojačano praćenje (vidjeti također pododjeljak o PML-u).
English: Tecfidera should be taken with food (see section 5.2).
Croatian: Tecfideru treba uzeti s hranom (vidjeti dio 5.2).
English: Symptoms may include new or worsening weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; or confusion or personality changes lasting for more than several days.
Croatian: Simptomi mogu uključivati novu ili pogoršanu slabost na jednoj strani tijela; nespretnost; promjene vida, razmišljanja ili pamćenja; ili smetenost ili promjene osobnosti koje traju dulje od nekoliko dana.
English: The experience in uncontrolled clinical trials is consistent with the experience in the placebo-controlled clinical trials.
Croatian: Iskustvo u nekontroliranim kliničkim ispitivanjima sukladno je iskustvu dobivenom u placebom kontroliranim kliničkim ispitivanjima.
English: If a patient misses a dose, a double dose should not be taken.
Croatian: Ako bolesnik propusti dozu, ne smije uzeti dvostruku dozu.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim slijedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: What Tecfidera looks like and contents of the pack
Croatian: Kako Tecfidera izgleda i sadržaj pakiranja
English: The lower fetal weight and delayed ossification were considered secondary to maternal toxicity (reduced body weight and food consumption).
Croatian: Manja težina fetusa i odgođeno okoštavanje smatrani su posljedicama toksičnosti za majke (smanjena tjelesna težina i potrošnja hrane).
English: Prior treatment with immunosuppressive or immunomodulating therapies
Croatian: Prethodne imunosupresivne ili imunomodulirajuće terapije
English: The annualised relapse rate for glatiramer acetate and placebo was 0.286 and 0.401 respectively in Study 2, corresponding to a reduction of 29% (p=0.013), which is consistent with approved prescribing information.
Croatian: Godišnja stopa relapsa za glatirameracetat i placebo je bila 0,286 odnosno 0,401 u Ispitivanju 2, što odgovara smanjenju od 29% (p = 0,013), a u skladu s odobrenim informacijama za propisivanje lijeka.
English: Carcinogenicity studies of dimethyl fumarate were conducted for up to 2 years in mice and rats.
Croatian: Ispitivanja kancerogenosti dimetilfumarata provedena su u razdoblju do 2 godine u miševa i štakora.