FrancophonIA/ELRC3.0 huggingface dataset:
English: Method and route of administration
Slovenian: Način in pot uporabe zdravila
English: Beyond 16 weeks, patients with inadequate response to Hefiya 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week.
Slovenian: Od 16. tedna dalje lahko bolnikom z nezadostnim odzivom na zdravilo Hefiya 40 mg vsak drugi teden koristi povečanje odmerka na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: In RA study IV, the ACR 20 response of patients treated with adalimumab plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
Slovenian: in standardno oskrbo, statistično značilno boljši kot pri bolnikih, zdravljenih s placebom in standardno oskrbo (p < 0,001).
English: Table 20 paediatric plaque psoriasis efficacy results at 16 weeks
Slovenian: rezultati učinkovitosti v 16. tednu pri pediatričnih bolnikih s psoriazo v plakih
English: The recommended dose of Hefiya for patients with enthesitis-related arthritis from 6 years of age is based on body weight (table 2).
Slovenian: Priporočeni odmerek zdravila Hefiya pri bolnikih z artritisom, povezanim z entezitisom, starih 6 let in več, temelji na telesni masi (preglednica 2).
English: Hefiya 40 mg solution for injection in pre-filled syringe adalimumab
Slovenian: Hefiya 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku adalimumab
English: Tachycardia
Slovenian: • dehidracija
English: If this dose does not work well enough, your doctor may prescribe an initial dose of 160 mg (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.
Slovenian: Če ta odmerek ne deluje dovolj dobro, lahko zdravnik vašega otroka predpiše začetni odmerek 160 mg (kot štiri 40-mg injekcije v enem dnevu ali kot dve 40-mg injekciji na dan dva zaporedna dneva), ki mu sledi 80 mg (kot dve 40-mg injekciji v enem dnevu) dva tedna kasneje.
English: These results suggest that some patients who have not responded by Week 4 benefit from continued maintenance therapy through Week 12.
Slovenian: To kaže, da lahko nadaljnje zdravljenje do 12. tedna koristi nekaterim bolnikom, ki se ne odzovejo do 4. tedna.
English: In monotherapy, some patients who experience a decrease in their response to Hefiya 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.
Slovenian: Med monoterapijo lahko nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo Hefiya 40 mg vsak drugi teden, koristi povečanje odmerka adalimumaba na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: In study UC-I, 390 TNF-antagonist naïve patients were randomised to receive either placebo at weeks 0 and 2, 160 mg adalimumab at week 0 followed by 80 mg at week 2, or 80 mg adalimumab at week 0 followed by 40 mg at week 2.
Slovenian: V študiji UC-I so 390 bolnikov, ki še niso prejemali antagonista TNF, randomizirali bodisi na placebo 0. in 2. teden, na adalimumab 0. teden in 80 mg 2. teden, ali na 80 mg 0. teden in 40 mg 2. teden.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TEXT
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: • Only remove the cap when you are ready to use the pen.
Slovenian: • Pokrovček odstranite šele, ko ste pripravljeni za uporabo injekcijskega peresnika.
English: At 10 years, 79 of 207 patients originally treated with 40 mg adalimumab every other week were evaluated radiographically.
Slovenian: Po 10 letih so rentgenografsko ocenili 79 od 207 bolnikov, ki so bili od začetka zdravljeni s 40 mg adalimumaba vsak drugi teden.
English: Carriers of HBV who require treatment with Hefiya should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Slovenian: Pri bolnikih, ki so pozitivni na okužbo s hepatitisom B, se priporoča posvetovanje z zdravnikom specialistom za zdravljenje okužb s hepatitisom B. Nosilce HBV, ki potrebujejo zdravljenje z zdravilom Hefiya, je treba ves čas zdravljenja in več mesecev po koncu zdravljenja natančno spremljati glede znakov in simptomov aktivne okužbe s HBV. O zdravljenju nosilcev HBV s protivirusno terapijo v kombinaciji z antagonistom TNF za preprečitev reaktivacije HBV ni zadostnih podatkov.
English: 40 mg adalimumab administered every other week c
Slovenian: 40 mg adalimumaba vsak drugi teden
English: Hefiya is contraindicated in moderate to severe heart failure (see section 4.3).
Slovenian: Pri bolnikih z zmernim ali hudim srčnim popuščanjem je zdravilo Hefiya kontraindicirano (glejte poglavje 4.3).
English: RA Study IIIa**
Slovenian: študija revmatoidnega artritisa IIIa**
English: Other serious infections seen in clinical trials include pneumonia, pyelonephritis, septic arthritis and septicaemia.
Slovenian: Med drugimi resnimi okužbami, zabeleženimi v kliničnih preskušanjih, so bile pljučnica, pielonefritis,
English: There is no relevant use of adalimumab in children aged less than 4 years for this indication.
Slovenian: Uporaba adalimumaba pri otrocih, starih manj kot 4 leta, za to indikacijo ni primerna.
English: If a faster response is required your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or 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, and thereafter as 40 mg every other week.
Slovenian: Če je potreben hitrejši odziv, vam zdravnik lahko predpiše začetni odmerek 160 mg (v štirih 40 mg injekcijah na dan ali v dveh 40 mg injekcijah dva dni zapored), ki mu sledi 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje in potem 40 mg vsak drugi teden.
English: On the basis of clinical trial data in patients with JIA (pJIA and ERA), an exposure-response relationship was established between plasma concentrations and PedACR 50 response.
Slovenian: (poliartikularnim idiopatskim artritisom (pJIA) in z artritisom, povezanim z entezitisom (ERA)) je bilo dokazano razmerje med izpostavljenostjo in odzivom med plazemskimi koncentracijami in PedACR (PedACR - American College of Rheumatology pediatric) odzivom.
English: Paediatric Crohn's disease
Slovenian: Crohnova bolezen pri pediatričnih bolnikih
English: Doses of 20 or 40 mg of adalimumab were given by subcutaneous injection every other week with placebo on alternative weeks or every week for 26 weeks; placebo was given every week for the same duration.
Slovenian: Bolniki so 26 tednov dobivali odmerka 20 ali 40 mg adalimumaba v subkutani injekciji vsak drugi teden s placebom vsak vmesni teden ali vsak teden;
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 starting two weeks later.
Slovenian: Običajna shema odmerjanja pri Crohnovi bolezni je 80 mg (kot dve 40-mg injekciji v enem dnevu) na začetku, čemur sledi 40 mg vsak drugi teden z začetkom dva tedna kasneje.
English: Some patients who experience decrease in their response to Hefiya 40 mg every other week may benefit from an increase in dosage to 40 mg Hefiya every week or 80 mg every other week.
Slovenian: Nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo Hefiya 40 mg vsak drugi teden, lahko koristi povečanje odmerka zdravila Hefiya na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis studies I-V.
Slovenian: V študijah revmatoidnega artritisa I−V so pri bolnikih ob več različnih časih testirali protitelesa v serumu.
English: • Hefiya pre-filled syringe/s (see Figure A).
Slovenian: • napolnjen(a) injekcijski(a) peresnik(a) (glejte sliko A).
English: No dose-limiting toxicity was observed during clinical trials.
Slovenian: V kliničnih študijah niso opazili toksičnih učinkov, ki bi omejevali odmerek.
English: low dose 20 / 10 mg eow N = 95
Slovenian: majhni odmerek 20/10 mg vsak drugi teden N = 95
English: • inflammation of the eye lid and eye swelling;
Slovenian: • vnetje veke in otekanje oči;
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi adipinska kislina citronska kislina monohidrat natrijev klorid manitol polisorbat 80 klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH) voda za injekcije
English: Hefiya 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.
Slovenian: Zdravilo Hefiya je na voljo v injekcijski brizgi za enkratno uporabo iz prozornega stekla tipa I z iglo iz nerjavečega jekla s ščitnikom za iglo z držalom, z gumijastim pokrovčkom za iglo in s plastičnim batom, ki vsebuje 0,8 ml raztopine.
English: Hefiya is only available as 40 mg pre-filled syringe / pre-filled pen.
Slovenian: Zdravilo Hefiya je na voljo samo v 40 mg napolnjeni injekcijski brizgi/napolnjenem injekcijskem peresniku.
English: The usual dose regimen is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg two weeks later.
Slovenian: Običajni začetni odmerek je 80 mg (kot dve 40 mg injekciji v enem dnevu), ki mu sledi 40 mg dva tedna kasneje.
English: Ask your doctor or pharmacist how to throw away medicines you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne potrebujete več, se posvetujte z zdravnikom ali farmacevtom.
English: Vertigo and visual impairment may occur following administration of Hefiya (see section 4.8).
Slovenian: Po dajanju zdravila Hefiya se lahko pojavita vrtoglavica in poslabšanje vida (glejte poglavje 4.8).
English: The recommended dose of Hefiya 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.
Slovenian: Priporočeno odmerjanje zdravila Hefiya za odrasle bolnike je začetni odmerek 80 mg subkutano in nato 40 mg subkutano vsak drugi teden, začenši en teden po začetnem odmerku.
English: • Do not use the 40 mg pre-filled syringe if doses other than 40 mg are recommended.
Slovenian: • Če je priporočeni odmerek manj kot 40 mg, ne smete uporabljati 40 mg napolnjenega injekcijskega peresnika.
English: Hefiya 40 mg solution for injection in single-use pre-filled SensoReady pen Hefiya is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with transparent window and label (SensoReady).
Slovenian: Zdravilo Hefiya je na voljo v napolnjeni injekcijski brizgi za enkratno uporabo, v peresniku trikotne oblike s prozornim okencem in oznako (peresnik SensoReady®).
English: There is no relevant use of adalimumab in children aged less than 6 years for this indication.
Slovenian: Uporaba adalimumaba pri otrocih, starih manj kot 6 let, za to indikacijo ni primerna.
English: • psoriasis,
Slovenian: • luskavice (psoriaze),
English: The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (as two 40 mg injections), followed by 40 mg given every other week starting one week after the initial dose.
Slovenian: Običajni začetni odmerek za odrasle z neinfekcijskim uveitisom je 80 mg (kot dve 40 mg injekciji), čemur sledi odmerek 40 mg, ki se ga daje vsaka dva tedna, z začetkom en teden po začetnem odmerku.
English: In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50 %, 26.4 % (92 / 349) and 37.8 % (132 / 349) of patients achieved PASI 75 response at week 12 and 24, respectively.
Slovenian: V odprti podaljšani študiji je odziv PASI 75 doseglo 93 od 349 (26,6 %) bolnikov, ki so jim zaradi odziva PASI pod 50 % odmerek povečali s 40 mg vsak drugi teden na 40 mg vsak teden ter so jih ocenili 12 tednov po povečanju odmerka.
English: In period A, patients received placebo or adalimumab at an initial dose of 80 mg followed by 40 mg every other week starting one week after the initial dose.
Slovenian: V obdobju A so bolniki dobivali placebo ali adalimumab v začetnem odmerku 80 mg in potem 40 mg vsak drugi teden, začenši en teden po začetnem odmerku.
English: The recommended Hefiya induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at week 2 (given as two 40 mg injections in one day).
Slovenian: Priporočena shema odmerjanja zdravila Hefiya med indukcijo je pri odraslih bolnikih z zmerno do hudo aktivnim ulceroznim kolitisom 160 mg 0. teden (aplicirano kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva dni zapored) in 80 mg 2. teden (aplicirano kot dve 40 mg injekciji v enem dnevu).
English: Each pre-filled pen contains 40 mg of adalimumab in 0.8 ml of solution.
Slovenian: En napolnjen injekcijski peresnik vsebuje 40 mg adalimumaba v 0,8 ml raztopine.
English: In the pivotal controlled trials in adults and children, the rate of infection was 1.51 per patient year in the adalimumab-treated patients and 1.46 per patient year in the placebo and active control-treated patients.
Slovenian: V kontroliranih preskušanjih, ki podpirajo vlogo za pridobitev dovoljenja za promet, pri odraslih in otrocih je bil delež okužb 1,51 na bolnikov-let med bolniki, ki so dobivali adalimumab,
English: Hefiya is available as a pre-filled syringe and a pre-filled pen (SensoReady).
Slovenian: Zdravilo Hefiya je lahko na voljo v napolnjeni injekcijski brizgi in napolnjenem injekcijskem peresniku (SensoReady).
English: Your Hefiya single-use pre-filled SensoReady pen
Slovenian: Vaš napolnjeni injekcijski peresnik SensoReady zdravila Hefiya za enkratno uporabo
English: Discontinuation of Hefiya therapy should be considered in patients with confirmed significant haematologic abnormalities.
Slovenian: Pri bolnikih s potrjenimi pomembnimi hematološkimi nepravilnostmi je treba razmisliti o prekinitvi terapije z zdravilom Hefiya.
English: • bruising;
Slovenian: • srbenje;
English: Adverse events of the haematologic system, including medically significant cytopenia (e.g. thrombocytopenia, leukopenia) have been reported with adalimumab.
Slovenian: Med uporabo adalimumaba so poročali o neželenih učinkih na hematološki sistem, vključno z medicinsko pomembno citopenijo (npr. trombocitopenijo, levkopenijo).
English: Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually first appear in childhood.
Slovenian: Poliartikularni juvenilni idiopatski artritis in artritis, povezan z entezitisom Poliartikularni juvenilni idiopatski artritis in artritis, povezan z entezitisom sta vnetni bolezni sklepov,
English: Table 19 Ps study IV efficacy results at 16, 26 and 52 weeks endpoint week 16 placebo-controlled week 26 placebo-controlled week 52 open-label placebo N = 108
Slovenian: Preglednica 19 študija pri psoriazi IV - rezultati učinkovitosti po 16, 26 in 52 tednih končna točka
English: The syringe inside the pen is made of type I glass with a stainless steel needle and an inner rubber needle cap, containing 0.8 ml of solution.
Slovenian: Brizga v peresniku je narejena iz prozornega stekla tipa I z iglo iz nerjavečegaa jekla, notranjim gumijastim pokrovčkom za iglo in gumijasto zaporko, ki vsebuje 0,8 ml raztopine.
English: Hefiya can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease.
Slovenian: Zmanjša lahko tudi bolečino, ki je pogosto povezana s to boleznijo.
English: • diverticulitis (inflammation and infection of the large intestine);
Slovenian: • divertikulitis (vnetje in okužba debelega črevesa);
English: The usual Hefiya 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.
Slovenian: Običajni začetni odmerek zdravila Hefiya pri odraslih z ulceroznim kolitisom je 160 mg (kot štiri 40 mg injekcije v enem dnevu ali po dve 40 mg injekciji na dan dva zaporedna dneva), nato 80 mg (kot dve 40 mg injekciji) dva tedna pozneje in nato 40 mg vsaka dva tedna.
English: Hefiya 40 mg solution for injection (injection) in pre-filled syringe is supplied as a 0.8 ml clear to slightly opalescent, colourless to slightly yellowish solution.
Slovenian: Zdravilo Hefiya 40 mg raztopina za injiciranje (injekcija) v napolnjeni injekcijski brizgi je na voljo kot bistra do rahlo opalescentna, brezbarvna do rahlo rumenkasta raztopina.
English: Adalimumab / methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and adalimumab monotherapy (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
Slovenian: Za doseganje nizkega stanja bolezni pri bolnikih z nedavno diagnosticiranim zmernim do hudim revmatoidnim artritisom je bila kombinirana terapija z adalimumabom in metotreksatom klinično in statistično boljša od monoterapije z metotreksatom (p < 0,001) in monoterapije z adalimumabom (p < 0,001).
English: Mood alterations (including depression), anxiety, insomnia
Slovenian: Psihiatrične motnje pogosti spremembe razpoloženja (vključno z depresijo),
English: The recommended Hefiya dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as two 40 mg injections in one day).
Slovenian: Priporočena shema odmerjanja zdravila Hefiya pri odraslih bolnikih s hidradenitis suppurativa (HS) je 160 mg na 1. dan (apliciranov obliki štirih 40 mg injiciranj na dan ali z dvema 40 mg injiciranjema na dan dva dni zapored), ki mu sledi 80 mg dva tedna kasneje na 15. dan (apliciranov obliki dveh 40 mg injiciranj v enem dnevu).
English: The recommended dose of Hefiya for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose.
Slovenian: Priporočeni začetni odmerek zdravila Hefiya za odrasle bolnike z uveitisom je 80 mg, čemur sledi 40 mg odmerek vsak drugi teden, ki se ga začne dajati en teden po začetnem odmerku.
English: PsA study II with 12-week duration, treated 100 patients who had an inadequate response to DMARD therapy.
Slovenian: V njej so zdravili 100 bolnikov, ki se niso ustrezno odzvali na imunomodulirajočo terapijo.
English: Uncommon (may affect up to 1 in 100 people)
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov)
English: MARKETING AUTHORISATION NUMBERS
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
English: The recommended dose of Hefiya is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg every other week starting one week later.
Slovenian: Priporočeno odmerjanje zdravila Hefiya je začetni odmerek 8 mg (kot dve 40-mg injekciji v enem dnevu), čemur sledi 40 mg vsak drugi teden z začetkom en teden po začetnem odmerku.
English: Hefiya is administered via subcutaneous injection.
Slovenian: Zdravilo Hefiya se odmerja v obliki subkutane injekcije.
English: The recommended dose of Hefiya for paediatric patients with uveitis from 2 years of age is based on body weight (table 5).
Slovenian: Uveitis pri pediatričnih bolnikih Priporočeni odmerek zdravila Hefiya pri pediatričnih bolnikih z uveitisom, starih 2 leti ali več, temelji na telesni masi (preglednica 5).
English: Mannitol
Slovenian: OVOJNINAH
English: Table 6 Undesirable effects
Slovenian: Neželeni učinki
English: Nervous system disorders*
Slovenian: Bolezni živčevja*
English: There is no relevant use of adalimumab in children aged less than 12 years in this indication.
Slovenian: Uporaba adalimumaba pri otrocih, mlajših od 12 let, za to indikacijo ni primerna.
English: Multipack containing 6 (3 packs of 2) pre-filled syringes in a blister Packs of 1 and 2 pre-filled pens
Slovenian: Pakiranja po 1 in 2 napolnjeni injekcijski brizgi v pretisnem omotu Večkratno pakiranje, ki vsebuje 6 (3 pakiranja po 2) napolnjenih injekcijskih brizg v pretisnem omotu.
English: Adalimumab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at week 24) compared with 0.0 ± 1.9 (p < 0.001) in the adalimumab group (at week
Slovenian: standardni odklon) 0,8 ± 2,5 v skupini s placebom (po 24 tednih) in 0,0 ± 1,9; (p < 0,001) v skupini z adalimumabom (po 48 tednih).
English: Treatment with Hefiya must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Slovenian: Pri bolnikih, ki se jim na novo pojavijo simptomi kongestivnega srčnega popuščanja ali se jim takšni simptomi poslabšajo, je treba zdravljenje z zdravilom Hefiya prekiniti.
English: One 0.8 ml pre-filled syringe contains 40 mg adalimumab.
Slovenian: En 0,8 ml napolnjen injekcijski peresnik vsebuje 40 mg adalimumaba.
English: GI haemorrhage, dyspepsia, gastroesophageal reflux disease, sicca syndrome
Slovenian: navzeja in bruhanje pogosti gastrointestinalna krvavitev, dispepsija, bolezen gastroezofagealnega refluksa, Sjögrenov sindrom občasni pankreatitis, disfagija, edem obraza redki intestinalna perforacija1)
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Hefiya.
Slovenian: nesteroidnih protivnetnih zdravil ali analgetikov.
English: double-blind response at week 68
Slovenian: dvojno slepa Odziv v 68. tednu placebo N = 153
English: Psychiatric disorders
Slovenian: KLINIČNI PODATKI
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Tuberculosis, including reactivation and new onset of tuberculosis, has been reported in patients receiving adalimumab.
Slovenian: Pri bolnikih, zdravljenih z adalimumabom, so poročali o tuberkulozi, vključno z reaktivacijo in novimi pojavi tuberkuloze.
English: • trouble breathing, swallowing;
Slovenian: • težave pri dihanju, požiranju;
English: Each 0.8 ml single-dose pre-filled syringe contains 40 mg of adalimumab.
Slovenian: Ena 0,8 ml napolnjena injekcijska brizga vsebuje 40 mg adalimumaba.
English: • scar;
Slovenian: • kap;
English: Two patients out of 3,441 treated with adalimumab in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new-onset lupus-like syndrome.
Slovenian: V vseh študijah revmatoidnega artritisa in psoriatičnega artritisa so se klinični znaki, ki so nakazovali novonastali lupusni sindrom, pojavili pri 2 od 3441 bolnikov, zdravljenih z adalimumabom.
English: In patients with ulcerative colitis, a loading dose of 160 mg adalimumab on week 0 followed by 80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 µg / ml during the induction period.
Slovenian: Pri bolnikih z ulceroznim kolitisom doseže polnilni odmerek 160 mg adalimumaba na 0. teden, ki mu sledi 40 mg adalimumaba 2. teden, med obdobjem indukcije najmanjšo koncentracijo v serumu približno 12 µg/ml.
English: Children and adolescents from 2 years of age weighing 30 kg or more
Slovenian: Otroci in mladostniki, stari od 4 do 17 let, ki tehtajo 30 kg ali več
English: B. PACKAGE LEAFLET
Slovenian: BESEDILO NA OMOTU
English: Inflammation
Slovenian: nespečnost
English: • do not shake the syringe.
Slovenian: • ne stresate injekcijske brizge.