FrancophonIA/ELRC3.0 huggingface dataset:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS HDPE vials (25 or 50 doses)
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA HDPE bočice (25 ili 50 doza)
English: Single intramuscular injection in the neck behind the ear of one dose (2 ml) to pigs from 3 weeks of age.
Croatian: Jedna intramuskularna injekcija, jedne doze (2 ml), u vrat iza uha, svinjama u dobi od 3 tjedna.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste material derived from the use of such products, if appropriate
Croatian: 6.6 Posebne mjere opreza prilikom odlaganja neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda, ako je prikladno
English: Shake well before administration and intermittently during the process of vaccination.
Croatian: Dobro protresite prije primjene te povremeno tijekom cijepljenja.
English: Fertility No information is available on the safety of this vaccine in breeding boars.
Croatian: Nema dostupnih informacija o neškodljivosti primjene ovog cjepiva u rasplodnih nerasta.
English: High density polyethylene vials of 50 ml, of 100 ml and of 250 ml (25, 50 and 125 doses), with a chlorobutyl elastomer closure and sealed with an aluminium cap.
Croatian: Bočica od polietilena visoke gustoće, od 50 ml, 100 ml i 250 ml (25, 50 i 125 doza), s klorbutilnim elastomernim čepom i brtvom s aluminijskim poklopcem.
English: 25 doses (50 ml) 50 doses (100 ml) 125 doses (250 ml)
Croatian: 25 doza (50 ml) 50 doza (100 ml) 125 doza (250 ml)
English: PACKAGE LEAFLET: Suvaxyn Circo emulsion for injection for pigs
Croatian: Suvaxyn Circo emulzija za injekciju za svinje
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: - česte (više od 1, ali manje od 10 na 100 tretiranih životinja) - manje česte (više od 1, ali manje od 10 na 1000 tretiranih životinja) - rijetke (više od 1, ali manje od 10 na 10000 tretiranih životinja)
English: 10 vial pack: 10 x 25 doses (50 ml) 10 vial pack: 10 x 50 doses (100 ml) 4 vial pack: 4 x 125 doses (250 ml)
Croatian: Pakovanje od 10 bočica: 10 x 25 doza (50 ml) Pakovanje od 10 bočica: 10 x 50 doza (100 ml) Pakovanje od 4 bočice: 4 x 125 doza (250 ml)
English: For active immunisation of pigs from 3 weeks of age against Porcine Circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues and fecal shedding caused by infection with PCV2.
Croatian: Za aktivnu imunizaciju svinja u dobi od 3 tjedna protiv cirkovirusa svinja tipa 2 (PCV2) kako bi se smanjila količina virusa u krvi i limfoidnim tkivima te izlučivanje virusa izmetom uzrokovano infekcijom virusom
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable.
Croatian: Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Intramuscular use.
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI) PRIMJENE
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE HDPE vials (125 doses)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU HDPE bočice (125 doza)
English: Disodium phosphate anhydrous Sodium phosphate dibasic heptahydrate Disodium tetraborate decahydrate EDTA tetrasodium
Croatian: Dinatrijev tetraborat dekahidrat EDTA tetranatrij Voda za injekcije
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals: Not applicable.
Croatian: Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama:
English: Cardboard box of 10 vials of 50 ml (25 doses ) or 100ml (50 doses).
Croatian: Kartonska kutija s 10 bočica od 50 ml (25 doza) ili 100ml (50 doza).
English: Cardboard box of 4 vials of 250 ml (125 doses)
Croatian: Kartonska kutija s 4 bočice od 250 ml (125 doza)
English: Cardboard box of 1 vial of 50 ml (25 doses), 100ml (50 doses) or 250 ml (125 doses).
Croatian: Kartonska kutija s 1 bočicom od 50 ml (25 doza), 100ml (50 doza) ili 250 ml (125 doza).
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNE TVAR I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: A transient increase in body temperature (on average 0.8°C) was observed 4 hours after administration of a 2fold overdose.
Croatian: Predoziranje (simptomi, hitni postupci, antidoti): Prolazno povećanje tjelesne temperature (za prosječno 0,8°C) uočeno je 4 sata nakon primjene dvostruko veće doze.
English: Monobasic potassium phosphate anhydrous Sodium chloride
Croatian: Monobazični kalijev fosfat, bezvodni
English: Duration of immunity: 23 weeks after vaccination
Croatian: Trajanje imuniteta:
English: Duration of immunity: 23weeks after vaccination
Croatian: 23 tjedna nakon cijepljenja.
English: Onset of immunity: from 3 weeks after vaccination.
Croatian: 3 tjedna nakon cijepljenja.
English: Special precautions for use in animals None
Croatian: 4.5 Posebne mjere opreza prilikom primjene Posebne mjere opreza prilikom primjene na životinjama
English: BELGIUM
Croatian: KARENCIJA
English: The vaccine contains an inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein.
Croatian: Cjepivo sadrži inaktivirani rekombinirani himerni cirkovirus svinja tip 1, koji sadrži ORF2 protein cirkovirusa svinja tipa
English: Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein
Croatian: Inaktivirani rekombinirani himerni cirkovirus svinja tip 1, koji sadrži ORF2 protein cirkovirusa svinja tipa 2
English: WITHDRAWAL PERIOD(S) Withdrawal period: Zero days
Croatian: Karencija: nula dana.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Croatian: Pročitati uputu o VMP prije primjene.
English: Active substance:
Croatian: Djelatne tvari:
English: STATEMENT OF ACTIVE SUBSTANCES Each dose (2 ml) contains: Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein
Croatian: KOLIČINA DJELATNE(IH) TVARI Inaktivirani rekombinirani himerni cirkovirus svinja tip 1, koji sadrži ORF2 protein cirkovirusa svinja tipa 2
English: Marketing authorization holder and manufacturer responsible for batch release: Zoetis Belgium SA
Croatian: Nositelj odobrenja za stavljanje u promet i proizvođač odgovoran za puštanje serije u promet:
English: SPECIAL WARNING(S)
Croatian: DODATAK II
English: The frequency of possible adverse effects is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Croatian: - rijetke (više od 1, ali manje od 10 na 10000 tretiranih životinja)
English: Call your doctor immediately.
Croatian: Odmah nazovite liječnika.
English: Your injection could take about 10 seconds.
Croatian: Injiciranje može potrajati oko 10 sekundi.
English: CI 95% for HRa
Croatian: 95% CI za HRa
English: Single use only.
Croatian: Samo za jednokratnu upotrebu.
English: 1) including spontaneous reporting data
Croatian: 1) uključujući podatke iz spontanog prijavljivanja
English: “Click”
Croatian: “klik”
English: Double-Blind Response at Week 68
Croatian: Dvostruko slijepi odgovor u 68. tjednu
English: Always take the outer carton of this medicine with you, even if it is empty.
Croatian: Vanjsko pakiranje lijeka uvijek ponesite sa sobom, čak i ako je prazno.
English: You can use:
Croatian: Možete odabrati:
English: This is part of the syringe.
Croatian: To je dio štrcaljke.
English: You may also wish to make a note of these details in case you are asked for this information in the future.
Croatian: I vi također možete zabilježiti te podatke u slučaju da Vas se zatraže te informacije u budućnosti.
English: Tell your healthcare provider if you are allergic to latex.
Croatian: Obavijestite zdravstvenog radnika ako ste alergični na lateks.
English: Dun Laoghaire, Co Dublin Ireland
Croatian: Dun Laoghaire, Co Dublin Irska
English: - if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: • Ako ste alergični na adalimumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open-label extension studies
Croatian: * detaljnije informacije mogu se pronaći u dijelovima 4.3, 4.4 i 4.8 ** uključujući otvorene produžetke ispitivanja
English: ASDAS Inactive Disease hs-CRPd,f,g
Croatian: ASDAS neaktivna bolest hs-CRPd,f,g
English: Other medicines and AMGEVITA
Croatian: Drugi lijekovi i AMGEVITA
English: The Patient Reminder Cards (adult and paediatric) contain the following key elements
Croatian: Kartica s podsjetnikom za bolesnika (odrasle i djecu) sadrži sljedeće ključne elemente
English: What AMGEVITA is and what it is used for
Croatian: Što je AMGEVITA i za što se koristi
English: Note: After you remove the pre-filled pen from your skin, the needle will be automatically covered.
Croatian: Napomena: Kada uklonite napunjenu brizgalicu s kože, igla će biti automatski pokrivena.
English: The window turns yellow When the injection is done
Croatian: Prozorčić postaje žut kada je injiciranje završeno
English: Important: When you remove the pre-filled pen, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means you have not received a full dose.
Croatian: Važno: Kada uklonite napunjenu brizgalicu, ako prozorčić nije postao žut, ili ako izgleda da injiciranje lijeka još traje, to znači da niste primili punu dozu.
English: - Any part appears cracked or broken.
Croatian: - Bilo koji dio napunjene štrcaljke izgleda napuknuto ili oštećeno.
English: ASAS partial remission BASDAIb 50
Croatian: ASAS djelomična remisija BASDAIb 50
English: You and your doctor should pay special attention to signs of infection while you are being treated with AMGEVITA.
Croatian: I Vi i Vaš liječnik morate obratite posebnu pažnju na znakove infekcije dok se liječite lijekom AMGEVITA.
English: There may be local guidelines for disposal.
Croatian: Možda postoje lokalni propisi o odlaganju.
English: Dry natural rubber
Croatian: Suha prirodna guma
English: You will also need these additional items, as they are not included in the carton:
Croatian: Također ćete trebati ostali pribor koji nije dio pakiranja:
English: Disease flares at the end of 32 weeksa (n/N)
Croatian: Reaktivacija bolesti pri kraju razdoblja od 32 tjednaa (n/N)
English: Ps study IV efficacy results at 16, 26 and 52 weeks
Croatian: Ispitivanje Ps IV rezultati djelotvornosti u 16., 26. i 52. tjednu
English: ● Do not leave the syringe in direct sunlight.
Croatian: Ne izlažite štrcaljku izravnoj sunčevoj svjetlosti.
English: Grab Here
Croatian: Uhvatite ovdje
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 March 2017
Croatian: Datum prvog odobrenja: 22. ožujka 2017.
English: What AMGEVITA looks like and contents of the pack
Croatian: Kako AMGEVITA izgleda i sadržaj pakiranja
English: OTHER SPECIAL WARNING(S), IF NECESSARY Contains latex, read the package leaflet before use.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Sadrži lateks, prije uporabe pročitajte uputu o lijeku.
English: Thousand Oaks, California
Croatian: One Amgen Center Drive Thousand Oaks, California
English: In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding.
Croatian: • U nekih bolesnika postoji mogućnost da tijelo ne uspije proizvesti dovoljne količine krvnih stanica koje Vam pomažu u borbi protiv infekcija ili zaustavljanju krvarenja.
English: Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted and 80% of patients continued to receive at least one of these medications.
Croatian: Istodobne stabilne doze aminosalicilata, kortikosteroida i/ili imunomodulatorskih lijekova bile su dozvoljene te je 80% bolesnika nastavilo uzimati barem jedan od ovih lijekova.
English: Firmly push the pre-filled pen down onto the skin until it stops moving.
Croatian: Čvrsto pritisnite napunjenu brizgalicu prema dolje na kožu, dok se ne prestane micati.
English: When you are ready to inject, press the blue start button.
Croatian: Kada ste spremni na injiciranje, stisnite plavo dugme za injiciranje.
English: Talk to your doctor or pharmacist before using AMGEVITA:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite lijek AMGEVITA:
English: Advise your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of contracting HBV.
Croatian: • Obavijestite svog liječnika ako ste nositelj virusa hepatitisa B (HBV), ako imate aktivni HBV ili mislite da biste se mogli zaraziti HBV-om.
English: If there is blood, press a cotton ball or gauze pad on your injection site.
Croatian: Ako ima krvi, pritisnite pamučnu vatu ili jastučić gaze na mjesto injiciranja.
English: When done, release your thumb, and gently lift the syringe off of your skin.
Croatian: Kada ste gotovi, otpustite palac i lagano odvojite štrcaljku od kože.
English: The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and non-randomised design.
Croatian: Na interpretaciju podataka mogu utjecati metodološka ograničenja ispitivanja, uključujući malu veličinu uzorka i dizajn koji nije uključivao randomizaciju.
English: Results from the overall UC-II study population are shown in table 28.
Croatian: Rezultati za ukupnu populaciju iz ispitivanja UC-II prikazani su u Tablici 28.
English: Glacial acetic acid
Croatian: Ledena acetatna kiselina
English: The decision to stop using AMGEVITA should be discussed with your doctor.
Croatian: Odluku o prekidu primjene lijeka AMGEVITA potrebno je raspraviti sa svojim liječnikom.
English: Carefully lift the pre-filled pen straight up out of the box.
Croatian: Pažljivo izvadite napunjenu brizgalicu ravno iz kutije.
English: Sodium hydroxide (for pH adjustment)
Croatian: Natrijev hidroksid (za podešavanje pH)
English: Week 52 Fistula remission3
Croatian: 52. tjedan Remisija fistula3
English: Maintenance regimen
Croatian: Režim održavanja
English: if you have a severe infection, including active tuberculosis (see “Warnings and precautions”).
Croatian: • Ako bolujete od teške infekcije, uključujući aktivnu tuberkulozu (pogledajte dio “Upozorenja i mjere opreza“).
English: In all cases, use a new syringe.
Croatian: U svim slučajevima, upotrijebite novu štrcaljku.
English: ● It is important that you do not try to give the injection unless you or your caregiver has received training.
Croatian: Važno je da ne pokušavate dati sebi injekciju ako niste prošli obuku od strane zdravstvenog radnika.
English: Important: You must push all the way down but do not touch the blue start button until you are ready to inject.
Croatian: Važno: Morate pritisnuti brizgalicu skroz do kraja, ali nemojte dirati plavo dugme za injiciranje dok god niste spremni na injiciranje.
English: Adalimumab binds specifically to TNF and neutralises the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors.
Croatian: Adalimumab se specifično veže za TNF (faktor tumorske nekroze) i neutralizira biološku funkciju TNFa blokirajući njegovu interakciju s površinskim staničnim TNF-receptorima p55 i p75.
English: 6.6 Special precautions for disposal and other handling Detailed instructions for use are provided in the package leaflet.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Detaljne upute za primjenu nalaze se u uputi o lijeku u pakiranju.
English: What AMGEVITA is and what it is used for What you need to know before you use AMGEVITA How to use AMGEVITA
Croatian: Što je AMGEVITA i za što se koristi Što morate znati prije nego počnete primjenjivati lijek AMGEVITA
English: - Do not inject into areas where the skin is tender, bruised, red, or hard.
Croatian: - Nemojte injicirati u područje gdje je koža osjetljiva, s modricama, crvena ili tvrda.
English: If you forget to give yourself an injection, you should inject the next dose of AMGEVITA as soon as you remember.
Croatian: Zaboravite li primijeniti injekciju, sljedeću dozu lijeka AMGEVITA morate primijeniti čim to primijetite.
English: C. Gather all materials needed for your injection.
Croatian: Prikupite sav pribor potreban za injiciranje.
English: Re-introduction of AMGEVITA after discontinuation for 70 days or longer should result in the same magnitudes of clinical response and similar safety profile as before dose interruption.
Croatian: Ponovno uvođenje lijeka AMGEVITA nakon prekida od 70 dana ili duže trebalo bi rezultirati jednako jakim kliničkim odgovorom i sličnim sigurnosnim profilom kao i primjena prije prekida terapije.
English: Your doctor will decide if you should receive AMGEVITA.
Croatian: Liječnik će odlučiti trebate li primiti lijek AMGEVITA.
English: - Your doctor will also give you a Patient Reminder Card, which contains important safety information that you need to be aware of before you are given AMGEVITA and during treatment with AMGEVITA.
Croatian: Liječnik će Vam također dati Karticu s podsjetnikom za bolesnika koja sadrži važne podatke o sigurnosti s kojima morate biti upoznati prije i za vrijeme liječenja lijekom AMGEVITA.
English: Clean your injection site with an alcohol wipe.
Croatian: Očistite mjesto injiciranja alkoholnom maramicom.
English: Longer term treatment with adalimumab 40 mg weekly for 96 weeks identified no new safety findings.
Croatian: U dugoročnom liječenju adalimumabom 40 mg tjedno tijekom 96 tjedana nisu otkrivene nove sigurnosne informacije.
English: Place your finger or thumb on edge of tray to secure it while you remove the syringe.
Croatian: Postavite svoj prst ili palac na rub podloge kako biste ju pridržali dok vadite štrcaljku.
English: - The expiration date printed on the label has passed.
Croatian: - Rok valjanosti naveden na naljepnici je istekao.
English: After proper training in injection technique, patients may self-inject with AMGEVITA if their physician determines that it is appropriate and with medical follow-up as necessary.
Croatian: Nakon odgovarajuće poduke o tehnici ubrizgavanja injekcija, bolesnici mogu sami sebi davati injekcije lijeka AMGEVITA ako njihov liječnik procijeni da je to moguće provesti, uz medicinsko praćenje po potrebi.
English: TNF-antagonists, such as AMGEVITA affect the immune system and their use may affect the body's defence against infection and cancer.
Croatian: Antagonisti TNF-a, kao što je AMGEVITA, djeluju na imunološki sustav te njihova primjena može utjecati na obranu tijela od infekcija i raka.
English: Step 3: Inject
Croatian: Korak 3: Injiciranje
English: The pen is a single use, disposable, handheld, mechanical injection device.
Croatian: Brizgalica je jednokratna, ručna, mehanička naprava za injiciranje.
English: • According to a pregnancy study, there was no higher risk of birth defects when the mother had received AMGEVITA during pregnancy compared with mothers with the same disease who did not receive AMGEVITA.
Croatian: • U ispitivanju provedenom u trudnica nije utvrđen povećan rizik od urođenih mana kada su majke primale lijek AMGEVITA tijekom trudnoće u odnosu na majke s istom bolešću koje nisu primale lijek AMGEVITA.
English: Efficacy results at 12 weeks, HS studies I and II
Croatian: Tablica 21. Rezultati djelotvornosti nakon 12 tjedana, ispitivanja HS I i II
English: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in table 6 below: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); and not known (cannot be estimated from the available data).
Croatian: Sljedeći popis nuspojava temelji se na iskustvu iz kliničkih ispitivanja i nakon stavljanja lijeka u promet, a prikazane su dolje u Tablici 6 prema organskom sustavu i učestalosti: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Significant response was first observed at week 2 and maintained through 24 weeks (table
Croatian: To se poboljšanje prvi put uočilo u drugom tjednu i održalo se 24 tjedna (Tablica 13).
English: If you are over 65 years you may be more susceptible to infections while taking AMGEVITA.
Croatian: • Ako ste stariji od 65 godina, možete biti podložniji infekcijama za vrijeme primjene lijeka AMGEVITA.
English: if you have moderate or severe heart failure.
Croatian: • Ako bolujete od umjerenog ili teškog zatajenja srca.
English: It is normal to see a drop of liquid at the end of the needle or yellow safety guard.
Croatian: Normalno je vidjeti kapljicu lijeka na vrhu igle ili na žutom sigurnosnom štitniku.
English: At week 4, subjects were randomised 1:1 based on their body weight at the time to either the low dose or standard dose maintenance regimens as shown in table 25.
Croatian: U četvrtom tjednu su ispitanici randomizirani u omjeru 1:1 na temelju njihove tjelesne težine u tom trenutku za liječenje niskom dozom ili standardnom dozom održavanja, kako je prikazano u Tablici 25.
English: AMGEVITA is intended for the treatment of the inflammatory diseases described below:
Croatian: AMGEVITA je namijenjena liječenju upalnih bolesti opisanih u nastavku:
English: Clinical response is usually achieved within 2-8 weeks of treatment.
Croatian: Klinički odgovor obično se postiže unutar 2-8 tjedana liječenja.
English: Step 2: Get ready
Croatian: Korak 2: Pripremite se
English: Week 16 Placebo-controlled
Croatian: 16. tjedan Placebom kontrolirano
English: ● Do not try to warm the syringe by using a heat source such as hot water or microwave.
Croatian: Ne pokušavajte ugrijati štrcaljku korištenjem izvora topline kao što su vruća voda ili mikrovalna pećnica.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with the reference medicinal product containing adalimumab in one or more subsets of the paediatric population in ulcerative colitis (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja s referentnim lijekom koji sadrži adalimumab u jednoj ili više podskupina pedijatrijske populacije u indikaciji ulceroznog kolitisa (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Flare was defined as ASDAS ≥ 2.1 at two consecutive visits four weeks apart.
Croatian: Pogoršanje je definirano kao ASDAS ≥ 2,1 kod dva uzastopna posjeta u razmaku od četiri tjedna.
English: Alternatively, if a patient has stopped AMGEVITA and signs and symptoms of disease recur, AMGEVITA may be re-administered.
Croatian: Alternativno, ako je bolesnik prestao uzimati lijek AMGEVITA, a znakovi i simptomi bolesti su se opet pojavili, AMGEVITA se može ponovno primijeniti.
English: -56.2a a p < 0.001, adalimumab versus placebo
Croatian: -56,2a a p < 0,001, adalimumab naspram placeba
English: PGA-F clear/minimal and ≥ 2-grade improvement
Croatian: PGA-F: bez bolesti/minimalno i poboljšanje za ≥ 2 stupnja (%)