FrancophonIA/ELRC3.0 huggingface dataset:
English: • It is important that you tell her baby's doctor and other health care professionals about her Humira use during her pregnancy before the baby receives any vaccine.
Croatian: • Važno je da liječnika njezina djeteta i druge zdravstvene radnike obavijestite o tome da je Vaša kći primjenjivala lijek Humira u trudnoći prije nego što njezino dijete primi bilo kakvo cjepivo.
English: If you do not respond well enough to these medicines, you will be given Humira to treat your rheumatoid arthritis.
Croatian: Ukoliko na njih ne reagirate dovoljno dobro, u svrhu liječenja Vašeg reumatoidnog artritisa bit će Vam propisan lijek Humira.
English: Table 13: Paediatric Plaque Psoriasis Efficacy Results at 16 Weeks
Croatian: Tablica 13: Rezultati djelotvornosti u pedijatrijskih bolesnika s plak psorijazom u 16. tjednu
English: In patients with Crohn's disease, anti-adalimumab antibodies were identified in 7/269 subjects (2.6%) and in 19/487 subjects (3.9%) with ulcerative colitis.
Croatian: Protutijela na adalimumab nađena su u 7/269 ispitanika (2,6%)s Crohnovom bolešću i 19/487
English: • pulmonary embolism (blockage in an artery of the lung)
Croatian: • plućna embolija (blokada u plućnoj arteriji)
English: Humira is used to treat severe ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
Croatian: Humira je namijenjena liječenju teškog oblika ankilozantnog spondilitisa i aksijalnog spondiloartritisa bez radiološkog dokaza ankilozantnog spondilitisa u odraslih.
English: Humira Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis
Croatian: Doza lijeka Humira za bolesnike s poliartikularnim juvenilnim idiopatskim artritisom Tjelesna težina bolesnika
English: Do not try to touch the needle.
Croatian: Ne dirajte iglu.
English: Opportunistic infections, including invasive fungal infections have been observed in patients receiving Humira.
Croatian: Druge oportunističke infekcije U bolesnika koji primaju lijek Humira zabilježene su oportunističke infekcije, uključujući invazivne gljivične infekcije.
English: • facial oedema associated with allergic reactions;
Croatian: • oteklina lica povezana s alergijskim reakcijama,
English: • Psoriatic arthritis
Croatian: • psorijatičnog artritisa
English: Your doctor may increase the dose frequency to 20 mg every week.
Croatian: Vaš liječnik Vam može povećati učestalost doziranja na 20 mg svaki tjedan.
English: Table 5 ACR Responses in RA Study V (percent of patients)
Croatian: Tablica 5 ACR odgovori u ispitivanju RA V (postotak bolesnika)
English: The Humira pre-filled syringe is available in a pack containing 2 pre-filled syringes with 2 alcohol pads.
Croatian: Napunjena štrcaljka lijeka Humira dostupna je u pakiranju koje sadrži 2 napunjene štrcaljke i
English: No malignancies were observed in 60 paediatric patients with an exposure of 58.4 patient years during a Humira trial in paediatric patients with uveitis.
Croatian: Zloćudne bolesti nisu primijećene u 60 pedijatrijskih bolesnika s izloženošću od 58,4 bolesnik-godine u ispitivanju lijeka Humira provedenom u pedijatrijskih bolesnika s uveitisom.
English: At Week 12, a significantly higher proportion of patients in Study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 21).
Croatian: U 12. je tjednu značajno veći udio bolesnika u ispitivanju HS-II doživio klinički značajno smanjenje kožne boli uzrokovane gnojnim hidradenitisom (vidjeti Tablicu 21).
English: Your doctor may prescribe an initial dose of 40 mg to be administered one week prior to the start of the usual dose of 20 mg every other week.
Croatian: Liječnik će možda propisati početnu dozu od 40 mg, koja će se primijeniti tjedan dana prije početka primjene uobičajene doze od 20 mg svaki drugi tjedan.
English: • In some patients the body may fail to produce enough of the blood cells that fight off infections or help you to stop bleeding.
Croatian: • U nekih bolesnika postoji mogućnost da tijelo ne uspije proizvesti dovoljne količine krvnih stanica koje se bore protiv infekcija ili pomažu u zaustavljanju krvarenja.
English: Table 20: Paediatric Plaque Psoriasis Efficacy Results at 16 Weeks
Croatian: Tablica 20: Rezultati djelotvornosti u pedijatrijskih bolesnika s plak psorijazom u 16. tjednu
English: Magyarország AbbVie Kft.
Croatian: AbbVie Kft.
English: Insert the needle all the way into the skin at about a 45degree angle with one quick, short motion.
Croatian: Jednim brzim, kratkim pokretom ubodite iglu cijelom dužinom u kožu pod kutom od približno 45 stupnjeva.
English: • DO NOT inject in an area where the skin is reddened, bruised, or hard.
Croatian: • NE ubrizgavajte u dio gdje je koža crvena, postoji modrica ili je tvrda.
English: Tel: +44 (0)1628 561090
Croatian: AbbVie Ltd Tel: +44 (0)1628 561090
English: There is limited safety experience of surgical procedures in patients treated with Humira.
Croatian: Raspoloživi podaci o sigurnosti kirurških zahvata u bolesnika liječenih lijekom Humira su ograničeni.
English: Neurological infections (including viral meningitis), opportunistic infections and tuberculosis (including coccidioidomycosis, histoplasmosis and mycobacterium avium complex infection), bacterial infections, eye infections, diverticulitis
Croatian: Nuspojava manje često neurološke infekcije (uključujući virusni meningitis), oportunističke infekcije i tuberkuloza (uključujući kokcidioidomikozu, histoplazmozu i infekciju kompleksom mycobacterium avium), bakterijske infekcije, infekcije oka, divertikulitis1)
English: • low blood measurements for red blood cells
Croatian: • niska razina crvenih krvnih stanica
English: Excipients: mannitol, polysorbate 80 and water for injections.
Croatian: Pomoćne tvari: manitol, polisorbat 80 i voda za injekcije.
English: At Week 12, a significantly higher proportion of patients in Study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 17).
Croatian: U 12. je tjednu značajno veći udio bolesnika u ispitivanju HS-II doživio klinički značajno smanjenje kožne boli uzrokovane gnojnim hidradenitisom (vidjeti Tablicu 17).
English: • facial oedema (swelling of the face)
Croatian: • edem lica (oticanje lica)
English: If you forget to give yourself an injection, you should inject the next dose of Humira as soon as you remember.
Croatian: Zaboravite li primijeniti injekciju, sljedeću dozu lijeka Humira morate ubrizgati čim se sjetite.
English: Table 17 Maintenance regimen Patient Weight
Croatian: Tablica 17 Režim održavanja
English: Some of those patients were also treated with azathioprine or 6- mercaptopurine.
Croatian: Neki od tih bolesnika su također uzimali i azatioprin ili 6-merkaptopurin.
English: Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline Physician's Global Assessment (PGA) score ranged from “moderate” (53% of subjects included) to “severe” (41%) to “very severe” (6%).
Croatian: Srednja početna vrijednost PASI rezultata u svim ispitivanim skupinama iznosila je 18,9, a rezultat prema općoj procjeni liječnika (PGA) kretao se u rasponu od „umjerenog“ (53% uključenih ispitanika) do
English: Patients received either placebo or
Croatian: (postotak bolesnika) Placebo
English: At Week 12, a significantly higher proportion of patients in Study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 11).
Croatian: U 12. je tjednu značajno veći udio bolesnika u ispitivanju HS-II doživio klinički značajno smanjenje kožne boli uzrokovane gnojnim hidradenitisom (vidjeti Tablicu 11).
English: 40 mg Humira every other week
Croatian: Humira 40 mg svaki drugi tjedan
English: Humira is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section
Croatian: Humira je indicirana za liječenje aktivnog artritisa povezanog s entezitisom u bolesnika u dobi od 6 godina i starijih u kojih nije postignut zadovoljavajući odgovor na konvencionalnu terapiju ili koji ne podnose takvu terapiju (vidjeti dio 5.1).
English: • pre-filled syringe has been dropped or crushed
Croatian: • napunjena brizgalica pala ili se slomila
English: • 160 mg at Week 0 and 80 mg at Week 2
Croatian: • 160 mg u nultom tjednu i 80 mg u drugom tjednu
English: Humira is indicated for treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Croatian: Humira je indicirana za liječenje umjerenog do teškog oblika aktivne Crohnove bolesti u odraslih bolesnika u kojih unatoč prethodnom potpunom i odgovarajućem tijeku liječenja kortikosteroidima i/ili imunosupresivima nije postignut odgovor, ili u bolesnika koji ne podnose takve terapije ili su im one kontraindicirane.
English: • If you receive Humira during your pregnancy, your baby may have a higher risk for getting an infection.
Croatian: • Ako primate lijek Humira tijekom trudnoće, Vaše dijete može imati povećan rizik od dobivanja infekcije.
English: If you have an inadequate response to Humira 40 mg every other week, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Croatian: Ako ne postignete zadovoljavajući odgovor na terapiju lijekom Humira u dozi od 40 mg svaki drugi tjedan, Vaš liječnik može povećati doziranje na 40 mg svaki tjedan ili 80 mg svaki drugi tjedan.
English: • If your child has active tuberculosis or other severe infections (see “Warnings and precautions”).
Croatian: • Ako Vaše dijete boluje od aktivne tuberkuloze ili drugih teških infekcija (pogledajte dio “Upozorenja i mjere opreza'').
English: With your index finger or your thumb, press the plum coloured button on top once you are ready to begin the injection (see below).
Croatian: Kada ste spremni za ubrizgavanje, kažiprstom ili palcem pritisnite bordo tipku na vrhu
English: Table 10 ACR Responses in RA Study V (percent of patients)
Croatian: Tablica 10 ACR odgovori u ispitivanju RA V (postotak bolesnika)
English: For storage information, see package leaflet.
Croatian: Za informacije o čuvanju, pogledajte uputu o lijeku.
English: Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases.
Croatian: Poliartikularni juvenilni idiopatski artritis i artritis povezan s entezitisom Poliartikularni juvenilni idiopatski artritis i artritis povezan s entezitisom upalne su bolesti.
English: If these medicines do not work well enough, your child will be given Humira to reduce the signs and symptoms of his/her disease.
Croatian: Ako ti lijekovi ne budu dovoljno djelotvorni, Vašem će djetetu u svrhu smanjenja znakova i simptoma bolesti biti propisan lijek Humira.
English: In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with Humira and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and Humira monotherapy at Week 52 and responses were sustained at Week 104 (see Table
Croatian: U ispitivanju RA V, u kojem su obuhvaćeni bolesnici u ranoj fazi reumatoidnog artritisa koji do tada nisu bili liječeni metotreksatom, kombiniranom primjenom lijeka Humira i metotreksata tijekom 52 tjedna postignut je brži i statistički značajno bolji ACR odgovor nego uz monoterapiju metotreksatom, odnosno lijekom Humira.
English: Table 18 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks Placebo N=53 n (%)
Croatian: Ps II (CHAMPION) - Rezultati djelotvornosti u 16. tjednu Placebo N=53 n (%)
English: Throw away the used pre-filled syringe in a special disposal container as instructed by your doctor, nurse or pharmacist.
Croatian: Uporabljenu napunjenu brizgalicu bacite u poseban spremnik za zbrinjavanje otpada, kako Vas je uputio Vaš liječnik, medicinska sestra ili ljekarnik.
English: Do not remove the pre-filled pen while the injection is being given.
Croatian: Ne pomičite napunjenu brizgalicu za vrijeme ubrizgavanja.
English: • elevated bilirubin measurement (liver blood test).
Croatian: • povišena razina bilirubina (vidljivo u nalazima krvne pretrage kojom se provjerava rad jetre).
English: The recommended dose of Humira for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Croatian: U odraslih bolesnika s reumatoidnim artritisom preporučena doza adalimumaba iznosi 40 mg, a daje se kao jednokratna doza svaka dva tjedna supkutanom injekcijom.
English: • musculoskeletal pain.
Croatian: • osip, • mišićno-koštana bol.
English: • elevated bilirubin measurement (liver blood test)
Croatian: • povišena razina bilirubina (vidljivo u nalazima krvne pretrage kojom se provjerava rad jetre)
English: • If your child received Humira during her pregnancy, her baby may have a higher risk for getting an infection.
Croatian: • Ako je Vaša kći primala lijek Humira tijekom trudnoće, njezino dijete može imati povećan rizik od dobivanja infekcije.
English: • Advise your doctor if you reside or travel in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are endemic.
Croatian: • Obavijestite svog liječnika ako ste boravili ili putovali u predjele u kojima su prisutne endemske gljivične infekcije kao što su histoplazmoza, kokcidioidomikoza ili blastomikoza.
English: If you do not respond well enough to these medicines, you will be given Humira.
Croatian: Ako na njih ne odgovorite dovoljno dobro, bit će Vam propisan lijek Humira.
English: In patients with at least a partial response to Humira 40 mg weekly at Week 12, the HiSCR rate at Week 36 was higher in patients who continued weekly Humira than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see Table 12).
Croatian: Humira u dozi od 40 mg svaki tjedan, stopa HiSCR-a zabilježena u 36. tjednu bila je veća u onih bolesnika koji su nastavili primati lijek Humira svaki tjedan nego u bolesnika kojima je učestalost doziranja smanjena na jednom svaki drugi tjedan ili onih kojima je liječenje ukinuto (vidjeti Tablicu 12).
English: After proper training, the injection can be selfadministered or given by another person, for example a family member or friend.
Croatian: Nakon primjerene obuke, injekciju si možete dati sami ili Vam je može dati druga osoba, primjerice član obitelji ili prijatelj.
English: Multiple sclerosis, demyelinating disorders (e.g. optic neuritis, Guillain-Barré syndrome)
Croatian: demijelinizirajući poremećaji (npr. optički neuritis,
English: Humira n=113
Croatian: Humirab n=113
English: Worsening or new onset of psoriasis(including palmoplantar pustular psoriasis) urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia1),
Croatian: često pogoršanje ili nova pojava psorijaze (uključujući palmoplantarnu pustuloznu psorijazu)1), urtikarija,
English: Patients with at least a partial response to Humira 40 mg weekly after 12 weeks of treatment.
Croatian: Humira u dozi od 40 mg svaki tjedan nakon 12 tjedana liječenja.
English: • Advise your doctor if your child resides or travels in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are endemic.
Croatian: • Obavijestite svog liječnika ako je Vaše dijete boravilo ili putovalo u predjele u kojima su prisutne endemske gljivične infekcije kao što su histoplazmoza, kokcidioidomikoza ili blastomikoza.
English: Humira should be used with caution in patients with mild heart failure (NYHA class I/II).
Croatian: Bolesnicima s blagim zatajenjem srca (NYHA razred I/II) Humira se mora davati oprezno.
English: • high blood measurements for white blood cells
Croatian: • visoka razina bijelih krvnih stanica
English: Your doctor may prescribe another strength of Humira if your child needs a different dose.
Croatian: Ako je Vašem djetetu potrebna drugačija doza, liječnik može propisati drugu jačinu lijeka Humira.
English: In CD Study I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at Weeks 0 and 2, 160 mg Humira at Week 0 and 80 mg at Week 2, 80 mg at Week 0 and 40 mg at Week 2, and 40 mg at Week 0 and 20 mg at Week 2.
Croatian: U ispitivanju CD I, 299 bolesnika koji nikad nisu primali terapiju antagonistima TNF-a randomizirani su u jednu od 4 terapijske skupine: placebo u nultom tjednu i nakon 2 tjedna, Humira 160 mg u nultom tjednu i 80 mg nakon 2 tjedna, Humira 80 mg u nultom tjednu i 40 mg nakon 2 tjedna, Humira 40 mg u nultom tjednu i 20 mg nakon 2 tjedna.
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 Humira and during treatment with Humira.
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 Humira.
English: • If your child has or develops a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if he/she should receive or continue to receive Humira.
Croatian: • Ako Vaše dijete boluje ili oboli od demijelinizirajuće bolesti (bolesti koja zahvaća izolacijski sloj koji obavija živce, kao što je multipla skleroza), odluku o tome smije li uzimati ili nastaviti primati lijek Humira donijet će liječnik.
English: The recommended dose of Humira for patients with Crohn's disease from 6 to 17 years of age is based on body weight (Table 4).
Croatian: Preporučena doza lijeka Humira za bolesnike s Crohnovom bolešću u dobi od 6 do 17 godina određuje se na temelju tjelesne težine (Tablica 4).
English: • reactivation of hepatitis B;
Croatian: • reaktivacija hepatitisa B,
English: If your child gets any side effects, talk to your child's doctor or pharmacist.
Croatian: Ako kod Vašeg djeteta primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika Vašeg djeteta ili ljekarnika.
English: Humira 40 mg solution for injection in pre-filled syringe Humira 40 mg solution for injection in pre-filled pen
Croatian: Humira 40 mg otopina za injekciju u napunjenoj štrcaljki Humira 40 mg otopina za injekciju u napunjenoj brizgalici
English: Humira Pre-filled Syringe
Croatian: Humira napunjena štrcaljka Klip
English: • leukemia (cancer affecting the blood and bone marrow);
Croatian: • leukemija (rak koji zahvaća krv i koštanu srž),
English: RA Study III a**
Croatian: Ispitivanje RA IIIa**
English: What the Humira pre-filled pen looks like and contents of the pack
Croatian: Kako napunjena brizgalica lijeka Humira izgleda i sadržaj pakiranja
English: Hepatosplenic T-cell lymphoma Merkel cell carcinoma (neuroendocrine carcinoma of the skin)
Croatian: karcinom Merkelovih stanica (neuroendokrini karcinom kože)1)
English: o One vial adapter (2) o One vial for paediatric use of Humira for injection (3) o Two alcohol pads (4) o One needle (5)
Croatian: o Jednu bočicu za injekciju lijeka Humira za pedijatrijsku uporabu (3)
English: • low blood measurements for phosphate
Croatian: • niska razina fosfata u krvi
English: Humira 80 mg solution for injection in pre-filled syringe Humira 80 mg solution for injection in pre-filled pen
Croatian: Humira 80 mg otopina za injekciju u napunjenoj štrcaljki Humira 80 mg otopina za injekciju u napunjenoj brizgalici
English: • Psoriasis,
Croatian: • svrbež,
English: In Psoriasis Studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at Week 16 (see Tables 17 and 18).
Croatian: U ispitivanjima Psoriasis Study I i II primarna mjera ishoda bio je udio bolesnika u kojih je od početka ispitivanja do 16. tjedna postignut odgovor PASI 75 (vidjeti Tablice 17 i 18).
English: Vertigo and visual impairment may occur following administration of Humira (see section 4.8).
Croatian: Nakon primjene lijeka Humira mogu se pojaviti vrtoglavica i poremećaji vida (vidjeti dio 4.8).
English: • You will be instructed by your doctor, nurse or pharmacist on the technique of injection.
Croatian: • U tehniku ubrizgavanja uputit će Vas liječnik, medicinska sestra ili ljekarnik.
English: Table 17 Ps Study I (REVEAL) - Efficacy Results at 16 Weeks Placebo N=398 n (%)
Croatian: Tablica 17 Ispitivanje Ps I (REVEAL) - Rezultati djelotvornosti u 16. tjednu Placebo N=398 n (%)
English: • Release the skin with the first hand
Croatian: • Pustite kožu iz ruke kojom ju držite
English: Serious allergic reactions associated with Humira were rare during clinical trials.
Croatian: Alergijske reakcije Tijekom kliničkih ispitivanja rijetko su prijavljivane ozbiljne alergijske reakcije povezane s primjenom lijeka Humira.
English: Your doctor may prescribe an initial dose of 80 mg to be administered one week prior to the start of the usual dose of 40 mg every other week.
Croatian: Liječnik će možda propisati početnu dozu od 80 mg, koja će se primijeniti tjedan dana prije početka primjene uobičajene doze od 40 mg svaki drugi tjedan.
English: • If you have active tuberculosis or other severe infections (see “Warnings and precautions”).
Croatian: • ako bolujete od aktivne tuberkuloze ili drugih teških infekcija (pogledajte dio “Upozorenja i mjere opreza“).
English: If these medicines do not work well enough, your child will be given Humira to treat his/her polyarticular juvenile idiopathic arthritis.
Croatian: Ako ti lijekovi ne budu dovoljno djelotvorni, Vašem će djetetu za liječenje poliartikularnog juvenilnog idiopatskog artritisa biti propisan lijek Humira.
English: • If you take Humira the risk of getting lymphoma, leukaemia, or other cancers may increase.
Croatian: • Rizik obolijevanja od limfoma, leukemije ili druge vrste raka može se povećati ako primjenjujete lijek Humira.
English: Humira 40 mg/0.8 ml injection adalimumab
Croatian: Humira 40 mg/0,8 ml otopina za injekciju adalimumab
English: Table 8 Ps Study I (REVEAL) - Efficacy Results at 16 Weeks Placebo N=398 n (%)
Croatian: Tablica 8 Ispitivanje Ps I (REVEAL) - Rezultati djelotvornosti u 16. tjednu Placebo N=398 n (%)
English: Your child's doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Croatian: Liječnik Vašeg djeteta može povećati doziranje na 40 mg svaki tjedan ili 80 mg svaki drugi tjedan.
English: • signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination;
Croatian: • znakove infekcije kao što su vrućica, mučnina, rane, problemi sa zubima, pečenje pri mokrenju,
English: • If your child has a severe infection, including active tuberculosis (see “Warnings and precautions”).
Croatian: • Ako Vaše dijete boluje od teške infekcije, uključujući aktivnu tuberkulozu (pogledajte dio “Upozorenja i mjere opreza'').
English: • You will be instructed by your doctor, nurse or pharmacist on the technique of self-injection.
Croatian: • U tehniku samostalnog ubrizgavanja uputit će Vas Vaš liječnik, medicinska sestra ili ljekarnik.
English: Hold the pre-filled pen with the grey cap (1) pointing up.
Croatian: Držite napunjenu brizgalicu tako da siva kapica (1) bude okrenuta prema gore.
English: • severe chronic plaque psoriasis in children and adolescents aged 4 to 17 years for whom topical therapy and phototherapies have either not worked very well or are not suitable.
Croatian: • teškog oblika kronične plak psorijaze u djece i adolescenata u dobi od 4 do 17 godina u kojih topikalna terapija i fototerapije nisu djelovale jako dobro ili nisu prikladne.