FrancophonIA/ELRC3.0 huggingface dataset:
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 adalimumab 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.
Slovenian: V študiji Crohnove bolezni I je bilo 299 bolnikov, ki pred tem še niso dobivali antagonistov TNF, randomizirali v eno od štirih skupin: placebo 0. in 2. teden, 160 mg adalimumaba 0. teden in 80 mg 2. teden, 80 mg 0. teden in 40 mg 2. teden oziroma 40 mg 0. teden in 20 mg 2. teden.
English: Subjects who flared during the double-blind period were allowed adalimumab 40 mg eow rescue therapy for at least 12 weeks.
Slovenian: Preiskovanci, pri katerih je v dvojno slepem obdobju prišlo do ponovnega zagona bolezni, so kot rešilno zdravljenje prejemali adalimumab 40 mg vsak drugi teden vsaj 12 tednov.
English: The recommended dose of Hulio for paediatric patients with uveitis from 2 years of age is based on body weight (Table 5).
Slovenian: Priporočeni odmerek zdravila Hulio pri pediatričnih bolnikih z uveitisom, starih 2 leti ali več, temelji na telesni masi (preglednica 5).
English: Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg: The recommended dose of Hulio is an initial dose of 20 mg, followed by 20 mg one week later, Thereafter the usual dose is 20 mg every other week.
Slovenian: Otroci in mladostniki, stari od 4 do 17 let, ki tehtajo od 15 kg do manj kot 30 kg: Priporočeni odmerek zdravila Hulio je začetni odmerek 20 mg, ki mu sledi 20 mg en teden kasneje.
English: Hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia, hyperglycaemia, hypophosphataemia, dehydration
Slovenian: Presnovne in prehranske motnje zelo pogosti zvišanje lipidov pogosti hipokaliemija, hiperurikemija, nenormalni nivo natrija v krvi, hipokalciemija, hiperglikemija, hipofosfatemija, dehidracija
English: Table 23: Induction of Clinical Remission and Response (Percent of Patients)
Slovenian: Preglednica 23: Indukcija klinične remisije in odziva (odstotek bolnikov)
English: Opportunistic infections, including invasive fungal infections have been observed in patients receiving adalimumab.
Slovenian: Pri bolnikih, ki so prejemali adalimumab, so opažali oportunistične okužbe, vključno z invazivnimi glivičnimi okužbami.
English: The decision to stop using Hulio should be discussed with your child's doctor.
Slovenian: Če je vaš otrok prenehal uporabljati zdravilo Hulio O odločitvi, da bi prenehali uporabljati zdravilo Hulio, se morate posvetovati z otrokovim zdravnikom.
English: In adolescent patients with inadequate response to Hulio 40 mg every other week, an increase in dosage to 40 mg every week or 80 mg every other week may be considered.
Slovenian: Pri mladostnikih z nezadostnim odzivom na zdravilo Hulio 40 mg vsak drugi teden je možno razmisliti o povečanju odmerka na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: After the needle is completely inserted, let go of the site you are squeezing.
Slovenian: Ko je igla v celoti v koži, spustite stisnjeno kožo.
English: Table 24: Maintenance of Clinical Remission and Response (Percent of Patients)
Slovenian: Preglednica 24: Vzdrževanje klinične remisije in odziva (odstotek bolnikov)
English: Hulio is contraindicated in moderate to severe heart failure (see section 4.3).
Slovenian: Pri bolnikih z zmernim do hudim srčnim popuščanjem je zdravilo Hulio kontraindicirano (glejte poglavje 4.3).
English: Table 11: Radiographic Mean Changes Over 12 Months in RA Study III
Slovenian: Preglednica 11: Povprečne rentgenografske spremembe v 12 mesecih študije revmatoidnega artritisa III
English: Adalimumab 40 mg eow N=814 n (%)
Slovenian: adalimumab 40 mg vsak 2. teden n = 814 n (%)
English: • You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Hulio injection.
Slovenian: Premislite o uporabi ustrezne kontracepcije za preprečitev nosečnosti in nadaljujte z njeno uporabo še najmanj 5 mesecev po tem, ko prejmete zadnjo injekcijo zdravila Hulio.
English: Step 16 - Dispose syringe & needle Each vial, syringe, vial adapter and needle are for single-use only.
Slovenian: Vsaka viala, brizga, adapter za vialo in igla so namenjeni samo za enkratno uporabo.
English: In adult patients with hidradenitis suppurativa, a dose of 160 mg adalimumab on week 0 followed by 80 mg on week 2 achieved serum adalimumab trough concentrations of approximately 7 to 8 μg/ml at week 2 and week 4.
Slovenian: Pri odraslih bolnikih s hidradenitis suppurativa doseže odmerek 160 mg adalimumaba 0. teden, ki mu sledi 80 mg adalimumaba 2. teden, najnižjo koncentracijo adalimumaba v serumu približno 7 do 8 µg/ml v 2. tednu in v 4. tednu.
English: o DO NOT use the syringe if the liquid is cloudy, discoloured, or has particles in it.
Slovenian: ◦ Injekcijske brizge NE uporabljajte, če je tekočina motna, razbarvana ali vsebuje delce.
English: Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis are inflammatory diseases of the spine.
Slovenian: Ankilozirajoči spondilitis in aksialni spondiloartritis brez radiografskega dokaza o ankilozirajočem spondilitisu sta vnetni bolezni hrbtenice.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PRE-FILLED SYRINGE
Slovenian: PODATKI, NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - NAPOLNJENA INJEKCIJSKA BRIZGA
English: EU/1/18/1319/005 2 pack
Slovenian: EU/1/18/1319/002 2 pakiranji
English: If this dose does not work well enough, your doctor may increase the dose frequency to 20 mg every week.
Slovenian: Če ta odmerek ne deluje dovolj dobro, lahko zdravnik poveča pogostnost odmerjanja na 20 mg vsak teden.
English: 56 patients (69.1%) had ACR 50 responses; and 43 patients (53.1%) had ACR 70 responses.
Slovenian: Med temi je 64 bolnikov (79,0 %) imelo odziv 20 po ACR; 56 bolnikov (69,1 %) je imelo odziv 50 po ACR in 43 bolnikov (53,1 %) je imelo odziv 70 po ACR.
English: All patients, and in particular patients with a medical history of extensive immunosuppressant therapy or psoriasis patients with a history of PUVA treatment should be examined for the presence of nonmelanoma skin cancer prior to and during treatment with Hulio.
Slovenian: Pred in med zdravljenjem z zdravilom Hulio je treba za nemelanomskega kožnega raka pregledati vse bolnike, še zlasti pa bolnike z anamnezo intenzivne imunosupresivne terapije in bolnike s psoriazo, ki so v preteklosti prejemali PUVA.
English: Adalimumab 40 mg eow N=108 n (%)
Slovenian: adalimumab 40 mg vsak 2. teden n = 108 n (%)
English: No malignancies were observed in 249 paediatric patients with an exposure of 655.6 patient years during adalimumab trials in patients with juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis).
Slovenian: Pri 249 pediatričnih bolnikih z juvenilnim idiopatskim artritisom (s poliartikularnim juvenilnim idiopatskim artritisom in artritisom, povezanim z entezitisom), ki so bili med preskušanji adalimumaba učinkovini izpostavljeni 655,6 bolnikov-let, niso ugotovili nobenega malignoma.
English: If your child develops new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of feet), you must contact your child's doctor immediately.
Slovenian: Če se simptomi srčnega popuščanja (npr. težko dihanje ali otekanje stopal) pri otroku pojavijo na novo ali se poslabšajo, se morate takoj posvetovati z otrokovim zdravnikom.
English: This medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) v 0,8 ml odmerku, kar v bistvu pomeni ''brez natrija''.
English: Hulio Dose for Patients with Enthesitis-Related Arthritis Patient Weight
Slovenian: Preglednica 2: Odmerjanje zdravila Hulio pri bolnikih z artritisom, povezanim z entezitisom
English: Table 9: ACR Responses in Placebo-Controlled Trials (Percent of Patients)
Slovenian: Preglednica 9: Odziv po ACR v študijah, kontroliranih s placebom (odstotek bolnikov)
English: Table 6: Undesirable Effects
Slovenian: Preglednica 6: Neželeni učinki Organski sistem Pogostnost
English: Vertigo and visual impairment may occur following administration of Hulio (see section 4.8).
Slovenian: Po dajanju zdravila Hulio se lahko pojavita vrtoglavica in poslabšanje vida (glejte poglavje 4.8).
English: What you need to know before giving your child Hulio Do not give Hulio - If your child is allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če je vaš otrok alergičen na adalimumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Table 7: ACR Responses in Placebo-Controlled Trials (Percent of Patients)
Slovenian: Preglednica 7: Odziv po ACR v študijah, kontroliranih s placebom (odstotek bolnikov)
English: ACR 50 week 12 week 24
Slovenian: ACR 50 12. teden 24. teden np np
English: If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately.
Slovenian: Če se simptomi srčnega popuščanja (npr. težko dihanje ali otekanje nog) pojavijo na novo ali se poslabšajo, se morate takoj posvetovati z zdravnikom.
English: Beyond 16 weeks, patients with inadequate response to Hulio 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 Hulio 40 mg vsak drugi teden koristi povečanje odmerka na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: In controlled Phase 3 trials of adalimumab in patients with rheumatoid arthritis and psoriatic arthritis with a control period duration ranging from 4 to 104 weeks, ALT elevations ≥ 3 x ULN occurred in 3.7% of adalimumab-treated patients and 1.6% of control-treated patients.
Slovenian: V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih z revmatoidnim artritisom in psoriatičnim artritisom s trajanjem kontrolnega obdobja od 4 do 104 tedne so se zvišanja ALT ≥ 3 × ULN (Upper Limits of Normal - zgornja normalna meja) pojavila pri 3,7 % bolnikov, zdravljenih z adalimumabom, in pri 1,6 % bolnikov v kontrolni skupini.
English: Table 8: ACR Responses in RA Study V (percent of patients)
Slovenian: Preglednica 8: Odzivi ACR v študiji revmatoidnega artritisa V (odstotek bolnikov)
English: The recommended dose of Hulio for patients with enthesitis-related arthritis from 6 years of age is based on body weight (Table 2).
Slovenian: Priporočeni odmerek zdravila Hulio pri bolnikih z artritisom, povezanim z entezitisom, starih 6 let in več, temelji na telesni masi (preglednica 2).
English: Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 μg/ml for adalimumab without concomitant methotrexate and 11.8 ± 4.3 μg/ml with concomitant methotrexate.
Slovenian: Po dajanju 24 mg/m² (do največ 40 mg) subkutano vsak drugi teden bolnikom z artritisom, povezanim z entezitisom, ki so bili stari od 6 do 17 let, je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja (vrednost merjena v 24. tednu) 8,8 ± 6,6 µg/ml med uporabo adalimumaba brez metotreksata in 11,8 ± 4,3 µg/ml med sočasno uporabo metotreksata.
English: In controlled trials of adalimumab (initial doses of 160 mg at week 0 and 80 mg at week 2, followed by 40 mg every week starting at week 4), in patients with hidradenitis suppurativa with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥ 3 x ULN occurred in 0.3% of adalimumab-treated patients and 0.6% of control-treated patients.
Slovenian: V kontroliranih preskušanjih z adalimumabom (v začetnem odmerku 160 mg v 0. tednu, ki mu sledi odmerek 80 mg v 2. tednu in potem 40 mg vsak teden z začetkom v 4. tednu), pri bolnikih s hidradenitis suppurativa in s trajanjem kontrolnega obdobja od 12 do 16 tednov se je zvišanje ALT
English: • DO NOT inject into scars or stretch marks.
Slovenian: • NE injicirajte v brazgotine ali strije.
English: Hulio is for subcutaneous injection.
Slovenian: Zdravilo Hulio je namenjeno za subkutano injiciranje.
English: adalimumab/methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 9).
Slovenian: Pri bolnikih, ki so dobivali adalimumab in metotreksat, je bilo po 6 in 12 mesecih (glejte preglednico 9) statistično značilno manj rentgenografskih znakov napredovanja kot pri bolnikih, ki so dobivali samo metotreksat.
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 (DMARD).
English: Table 10: Radiographic Mean Changes at week 52 in RA Study V
Slovenian: Preglednica 10: Povprečne rentgenografske spremembe po 52 tednih študije revmatoidnega artritisa V
English: In monotherapy, some patients who experience a decrease in their response to Hulio 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 Hulio 40 mg vsak drugi teden, koristi povečanje odmerka adalimumaba na 40 mg vsak teden ali na 80 mg vsak drugi 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 Hulio 40 mg every other week may benefit from an increase in dosage to 40 mg Hulio every week or 80 mg every other week.
Slovenian: Nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo Hulio 40 mg vsak drugi teden, lahko koristi povečanje odmerka zdravila Hulio na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: The patients received 24 mg/m2 body surface area (BSA) of adalimumab up to a maximum of 20 mg every other week as a single dose via SC injection for at least 24 weeks.
Slovenian: Bolniki so vsaj 24 tednov prejemali adalimumab v odmerku 24 mg/m² telesne površine (in do največ 20 mg) vsak drugi teden kot enkraten odmerek v subkutani injekciji.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Hulio 40 mg solution for injection in pre-filled syringe Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab.
Slovenian: Hulio 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena 0,8 ml napolnjena injekcijska brizga z enim odmerkom vsebuje 40 mg adalimumaba.
English: Hulio Dose for Paediatric Patients with Plaque Psoriasis Patient Weight
Slovenian: Preglednica 3: Odmerjanje zdravila Hulio pri pediatričnih bolnikih s psoriazo v plakih
English: Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) who were 4 to 17 years the mean trough steady-state (values measured from week 20 to 48) serum adalimumab concentration was 5.6± 5.6 μg/ml (102% CV) for adalimumab without concomitant methotrexate and 10.9 ± 5.2 μg/ml (47.7% CV) with concomitant methotrexate.
Slovenian: Po uporabi 24 mg/m² (do največ 40 mg) subkutano vsak drugi teden pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, starih od 4 do 17 let, je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja (vrednosti merjene od 20. do 48. tedna) med uporabo adalimumaba brez sočasnega odmerjanja metotreksata 5,6 ± 5,6 µg/ml (koeficient variacije 102 %) in med uporabo z metotreksatom 10,9 ± 5,2 µg/ml (koeficient variacije 47,7 %).
English: • DO NOT use the pen if the needle cap is missing or not securely attached.
Slovenian: • NE uporabljajte injekcijskega peresnika, če je brez pokrovčka igle ali če pokrovček ni trdno nameščen.
English: Clinical response is decrease from baseline in Mayo score ≥3 points and ≥30% plus a decrease in the rectal bleeding subscore [RBS] ≥1 or an absolute RBS of 0 or 1; * p<0.05 for adalimumab vs. placebo pairwise comparison of proportions **p<0.001 for adalimumab vs. placebo pairwise comparison of proportions a Of those receiving corticosteroids at baseline
Slovenian: Klinični odziv pomeni znižanje ocene Mayo od začetka za ≥ 3 točke in ≥ 30 % ter znižanje podocene rektalne krvavitve [RBS] ≥ 1 ali absolutna RBS 0 ali 1.
English: Table 10: ACR Responses in RA Study V (percent of patients)
Slovenian: Preglednica 10: Odzivi ACR v študiji revmatoidnega artritisa V (odstotek bolnikov)
English: Hulio 40 mg solution for injection in pre-filled syringe Hulio 40 mg solution for injection in pre-filled pen
Slovenian: Hulio 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Hulio 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: It is recommended that your child uses an antiseptic wash daily on the affected areas.
Slovenian: Priporočljivo je, da vaš otrok na prizadetih predelih vsak dan uporabi antiseptično milo.
English: Preparing the pre-filled syringe
Slovenian: Priprava napolnjene injekcijske brizge
English: Hulio 40 mg solution for injection in pre-filled syringe adalimumab
Slovenian: Hulio 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku adalimumab
English: Children or adolescents from 6 to 17 years weighing less than 40 kg:
Slovenian: Otroci ali mladostniki, stari od 6 do 17 let, ki tehtajo manj kot 40 kg:
English: Step 7 - Attach syringe to vial adapter and push plunger rod Hold the syringe on the graduated area and remove it from the packaging.
Slovenian: 7. korak -Namestite brizgo na adapter za vialo in potisnite nosilec bata.
English: • 6 pre-filled syringes (with 6 alcohol pads)
Slovenian: • 6 napolnjenih injekcijskih brizg (s 6 alkoholnimi zloženci)
English: Each Hulio pre-filled syringe contains 38.2 mg of sorbitol.
Slovenian: Vsaka napolnjena injekcijska brizga zdravila Hulio vsebuje 38,2 mg sorbitola.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1319/004 1 pack
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1319/001 1 pakiranje
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1319/008
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1319/008
English: • DO NOT touch the vial stopper after wiping with the alcohol pad.
Slovenian: • Potem, ko ste zaporko viale obrisali z alkoholnim zložencem, se zaporke NE DOTIKAJTE.
English: 14 weeks a Ped ACR 30/50/70 responses week 48 significantly greater than those of placebo treated patients b p = 0.015 c p = 0.031
Slovenian: 20 tednov > 32 tednov 14 tednov a Odzivi »Ped ACR« 30/50/70 so bili 48. teden značilno večji kot pri bolnikih, ki so dobivali placebo.
English: Adalimumab/methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 11).
Slovenian: Pri bolnikih, ki so dobivali adalimumab in metotreksat, je bilo po 6 in 12 mesecih (glejte preglednico 11) statistično značilno manj rentgenografskih znakov napredovanja kot pri bolnikih, ki so dobivali samo metotreksat.
English: Your child's doctor will test your child for HBV. Hulio can reactivate HBV infection in people who carry this virus.
Slovenian: Zdravnik bo vašega otroka testiral na HBV.
English: In Period A, patients received placebo or adalimumab at an initial dose of 160 mg at week 0, 80 mg at week 2, and 40 mg every week starting at week 4 to week 11.
Slovenian: V obdobju A so bolniki prejemali placebo ali adalimumab v začetnem odmerku 160 mg v 0. tednu, nato 80 mg v 2. tednu in 40 mg vsak teden od 4. tedna do 11. tedna.
English: Hulio is also available as a pre-filled syringe or a pre-filled pen.
Slovenian: Zdravilo Hulio je na voljo tudi v napolnjeni injekcijski brizgi ali napolnjenem injekcijskem peresniku.
English: DO NOT twist the needle cap.
Slovenian: NE VRTITE pokrovčka igle.
English: In Psoriasis Study I, 28% of patients who were PASI 75 responders and were re-randomised to placebo at week 33 compared to 5% continuing on adalimumab, p<0.001, experienced “loss of adequate response” (PASI score after week 33 and on or before week 52 that resulted in a <PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to week 33).
Slovenian: V študiji pri psoriazi I so 33. teden ''izgubo ustreznega odziva'' zabeležili pri 28 % bolnikov, ki so dosegli odziv PASI 75 in so bili ob ponovni randomizaciji razvrščeni na placebo, in pri 5 % bolnikov, ki so še naprej dobivali adalimumab (p < 0,001).
English: Placebo/ MTXa
Slovenian: placebo/MTXa adalimumab/MTX
English: Table 12: Radiographic Mean Changes at week 52 in RA Study V
Slovenian: Preglednica 12: Povprečne rentgenografske spremembe po 52 tednih študije revmatoidnega artritisa V
English: • DO NOT re-cap the needle.
Slovenian: • Pokrovčka NE nameščajte nazaj na iglo.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1319/007
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1319/007
English: RA Study IIIa**
Slovenian: Študija revmatoidnega artritisa IIIa**
English: Step 3 - Partially open syringe and needle packaging Partially peel open the syringe package from the end closest to the white plunger rod.
Slovenian: Delno odprite ovojnino injekcijske brizge tako, da jo odlepite od konca, ki je najbližji belemu nosilcu bata.
English: Follow the steps below carefully each time you inject Hulio:
Slovenian: Pri vsakem injiciranju zdravila Hulio natančno sledite naslednjim korakom:
English: • 1 pre-filled syringe
Slovenian: • 1 napolnjen injekcijski peresnik;
English: Hulio 40 mg/0.8 ml solution for injection
Slovenian: IME ZDRAVILA Hulio 40 mg/0,8 ml raztopina za injiciranje
English: If a faster response is required, your child's doctor may prescribe an initial dose of 80 mg (as two 40 mg injections in one day) followed by 40 mg two weeks later.
Slovenian: Če je potreben hitrejši odziv, lahko zdravnik vašemu otroku predpiše začetni odmerek 80 mg (kot dve 40 mg injekciji v enem dnevu), ki mu sledi 40 mg dva tedna kasneje.
English: Follow the below steps carefully each time you inject Hulio pre-filled syringe:
Slovenian: Pri vsakem injiciranju zdravila Hulio v napolnjeni injekcijski brizgi natančno sledite naslednjim korakom:
English: Low Dose 20/10 mg eow N = 95
Slovenian: Majhni odmerek 20/10 mg vsak drugi teden N = 95
English: 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: Polnilni odmerek 160 mg adalimumaba na 0. teden, ki mu sledi 80 mg adalimumaba 2. teden, doseže med obdobjem indukcije najmanjšo koncentracijo v serumu približno 12 µg/ml.
English: CD Study II: Infliximab Experienced Patients
Slovenian: Študija pri Crohnovi bolezni I: Bolniki, ki še niso dobivali infliksimaba
English: In patients with Crohn's disease, the loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 5.5 μg/ml during the induction period.
Slovenian: Pri bolnikih s Crohnovo boleznijo doseže polnilni odmerek 80 mg adalimumaba 0. teden, ki mu sledi 40 mg adalimumaba 2. teden, v obdobju indukcije najmanjšo koncentracijo v serumu približno 5,5 µg/ml.
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 sindrom, podoben lupusu, pojavili pri 2 od 3441 bolnikov, zdravljenih z adalimumabom.
English: EU/1/18/1319/006 6 pack
Slovenian: EU/1/18/1319/003 6 pakiranj