natgillin/translations-raw huggingface dataset:
Table 16 ACR response in placebo-controlled psoriatic arthritis studies (percent of patients)
odziv ACR v študijah pri psoriatičnem artritisu, kontroliranih s placebom
Hefiya dose for patients with enthesitis-related arthritis Patient weight
Odmerjanje zdravila Hefiya pri bolnikih z artritisom, povezanim z entezitisom
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.
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.
EU/1/18/1287/006 6 pre-filled pens (3 packs of 2)
EU/1/18/1287/006 6 napolnjenih injekcijskih peresnikov (3 pakiranja po 2)
Population pharmacokinetic and pharmacokinetic / pharmacodynamic modelling and simulation predicted comparable adalimumab exposure and efficacy in patients treated with 80 mg every other week when compared with 40 mg every week (including adult patients with RA, HS, UC, CD or Ps, patients with adolescent HS, and paediatric patients ≥ 40 kg with CD).
80 mg vsak drugi teden v primerjavi s 40 mg vsak teden (vključno z odraslimi bolniki z RA, HS, UC, CD ali Ps, mladostniki s HS in pediatričnimi bolniki ≥ 40 kg s CD).
In the open-label extension for RA study III, most patients who were ACR responders maintained response when followed for up to 10 years.
V odprtem podaljšanju študije revmatoidnega artritisa III se je večina bolnikov, ki so se odzvali na
adalimumab 40 mg weekly N = 70
adalimumab 40 mg vsak teden N = 70
The blinded period was followed by an open-label period during which patients received adalimumab 40 mg every other week subcutaneously for up to an additional 28 weeks.
Slepljenemu obdobju je sledilo odprto obdobje, med katerim so bolniki dobivali 40 mg adalimumaba vsak drugi teden subkutano, do največ dodatnih 28 tednov.
Hefiya is used to treat ulcerative colitis in adults.
Zdravilo Hefiya se uporablja za zdravljenje ulceroznega kolitisa pri odraslih.
Neurological infections (including viral meningitis), opportunistic infections and tuberculosis (including coccidioidomycosis, histoplasmosis and mycobacterium avium complex infection), bacterial infections, eye infections, diverticulitis1)
oportunistične okužbe in tuberkuloza (vključno s kokidioidomikozo, histoplazmozo in kompleksno okužbo z Mycobacterium avium),
No malignancies were observed in 60 paediatric patients with an exposure of 58.4 patient years during an adalimumab trial in paediatric patients with uveitis.
Pri 60 pediatričnih bolnikih z uveitisom, ki so bili med preskušanji adalimumaba izpostavljeni 58,4 bolnikov-let, niso ugotovili nobenega malignoma.
At 8 years, 81 of 207 patients originally treated with 40 mg adalimumab every other week were evaluated radiographically.
81 od 207 bolnikov, ki so bili zdravljeni s 40 mg adalimumaba vsak drugi teden, so rentgenografsko ocenili po 8 letih.
RA study I at 24 weeks, RA study II at 26 weeks , and RA study III at 24 and 52 weeks b
Študija revmatoidnega artritisa I po 24 tednih, študija revmatoidnega artritisa II po 26 tednih in študija revmatoidnega artritisa III po 24 in 52 tednih b 40 mg adalimumaba vsak drugi teden c
solution for injection
raztopina za injiciranje
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.
Pri odraslih bolnikih s hidradenitis suppurativa doseže odmerek 160 mg adalimumaba na 0. teden, ki mu sledi 80 mg adalimumaba 2. teden, najnižjo koncentracijo adalimubaba v serumu pred naslednjim odmerkom približno 7 do 8 µg/ml v 2. tednu in v 4. tednu.
CD study II: infliximabexperienced patients placebo N = 74
(odstotek bolnikov) študija pri Crohnovi bolezni I: bolniki, ki še niso dobivali infliksimaba študija pri Crohnovi bolezni II: bolniki, ki so že dobivali infliksimab placebo n = 74
Polyarticular juvenile idiopathic arthritis from 2 years of age The recommended dose of Hefiya for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (table 1).
Priporočeni odmerek zdravila Hefiya pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom od 2. leta starosti, temelji na telesni masi (preglednica 1).
Children and adolescents from 6 to 17 years of age weighing 40 kg or more
Otroci in mladostniki, stari od 6 do 17 let, ki tehtajo 40 kg ali več
• migraine;
• migrena;
Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections.
Pri teh bolnikih je pri postavitvi diagnoze in izbiri empiričnega antimikotičnega zdravljena potreben posvet z zdravnikom, izkušenim v zdravljenju bolnikov z invazivnimi glivičnimi okužbami.
Hefiya is used to treat moderate to severe plaque psoriasis in adults.
Zdravilo Hefiya se uporablja za zdravljenje zmerne do hude luskavice (psoriaze) v plakih pri odraslih.
The double-blind period is followed by an open-label (OL) period during which patients received 24 mg / m2 BSA of adalimumab up to a maximum of 40 mg every other week subcutaneously for up to an additional 192 weeks.
Obdobju dvojno slepega preskušanja je sledilo obdobje odprtega preskušanja, v katerem so bolniki prejemali 24 mg/m2 telesne površine adalimumaba do največjega posamičnega odmerka 40 mg vsak drugi teden subkutano do največ 192 tednov.
If a faster response is required, your doctor may prescribe an initial dose of 80 mg (as two 40 mg injections in one day) followed by 40 mg starting two weeks later.
Če je potreben hitrejši odziv, lahko zdravnik vašega otroka predpiše začetni odmerek 80 mg (kot dve 40 mg injekciji v enem dnevu), ki mu sledi 40 mg z začetkom dva tedna kasneje.
Hefiya 40 mg solution for injection in pre-filled syringe Hefiya 40 mg solution for injection in pre-filled pen
Hefiya 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Hefiya 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
Serious adverse reactions have been reported for adalimumab.
Poročali so tudi o resnih neželenih učinkih v zvezi z adalimumabom.
Be sure that you read, understand, and follow these Instructions for Use before injecting Hefiya.
Preden injicirate zdravilo Hefiya, morate ta navodila za uporabo prebrati, razumeti in jih upoštevati.
• In addition cases of non-melanoma skin cancer have been observed in patients taking adalimumab.
• Pri bolnikih, zdravljenih z adalimumabom, opazili primere nemelanomskega kožnega raka.
Your Hefiya single-use pre-filled syringe with needle guard and add-on finger flange
Vaša napolnjena injekcijska brizga zdravila Hefiya z varovalnim pokrovčkom in držalom
If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Če ta odmerek ne deluje dovolj dobro, vam bo zdravnik lahko odmerek povečal na 40 mg vsak teden ali na 80 mg vsak drugi teden.
Your doctor may also prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual dose.
Zdravnik lahko predpiše začetni odmerek 40 mg, ki se ga lahko uporabi en teden pred začetkom zdravljenja z običajnim odmerkom.
• Press your pen firmly against the skin to start the injection (see
• Injekcijski peresnik pritisnite trdno ob kožo in sprožite injiciranje (glejte sliko H).
There is limited safety experience in patients undergoing arthroplasty while receiving adalimumab.
Izkušnje z varnostjo pri bolnikih, ki so jim med zdravljenjem z adalimumabom opravili artroplastiko, so omejene.
Adalimumab-treated patients showed statistically significant improvements at week 26 compared with placebo in the DLQI.
Pri bolnikih, zdravljenih z adalimumabom, je prišlo do statistično značilnega izboljšanja dermatološkega indeksa kakovosti življenja (DLQI) po 26 tednih v primerjavi z placebom.
Always use this medicine exactly as your doctor or pharmacist has told you.
Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika ali farmacevta.
Patient weight
Masa bolnika
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.
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.
In CD study I and CD study II, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at week 4 in patients randomised to adalimumab 80 / 40 mg and 160 / 80 mg compared to placebo and was seen at weeks 26 and 56 in CD study III as well among the adalimumab treatment groups compared to the placebo group.
randomiziranih na shemi z adalimumabom 80/40 mg in 160/80 mg, v primerjavi s placebom; razliko 26. in 56. teden je v skupinah, zdravljenih z adalimumabom, v primerjavi s placebom pokazala tudi študija pri Crohnovi bolezni III.
Hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia hyperglycaemia, hypophosphataemia, dehydration
Presnovne in prehranske motnje zelo pogosti zvišanje lipidov pogosti hipokalemija, hiperurikemija, nenormalni nivo natrija v krvi, hipokalcemija, hiperglikemija, hipofosfotemija, dehidracija
g n=73 placebo and n=70 adalimumab h
(mg/L) g n = 73 placebo in n = 70 adalimumab h SPARCC = Kanadski raziskovalni konzorcij za spondiloartritis (Spondyloarthritis Research Consortium of Canada)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN LABEL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
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 Hefiya.
Pred zdravljenjem z zdravilom Hefiya in med zdravljenjem z njim je treba za nemelanomskega kožnega raka pregledati vse bolnike, še zlasti pa bolnike z anamnezo intenzivne imunosupresivne terapije in bolnike s psoriazo, ki so kdaj prejemali PUVA.
Paediatric ulcerative colitis
Ulcerozni kolitis pri pediatričnih bolnikih
Figure H: insert the needle
Slika H: Vstavite iglo
There is no relevant use of Hefiya in children aged less than 2 years in this indication.
Uporaba zdravila Hefiya pri otrocih, mlajših od 2 let, za to indikacijo ni primerna.
Renal and / or hepatic impairment
Okvara jeter in/ali ledvic
EU/1/18/1287/004 1 pre-filled pen EU/1/18/1287/005 2 pre-filled pens
EU/1/18/1287/004 1 napolnjen injekcijski peresnik EU/1/18/1287/005 2 napolnjena injekcijska peresnika
Enthesitis-related arthritis
Artritis, povezan z entezitisom
N failure median time to HRa CI 95 % p Value b treatment
RTa IZ 95 % za RTa p
In adolescent patients with inadequate response to Hefiya 40 mg every other week, an increase in dosage to 40 mg every week or 80 mg every other week may be considered.
Pri mladostnikih z nezadostnim odzivom na zdravilo Hefiya 40 mg vsak drugi teden je možno razmisliti o povečanju odmerka na 40 mg vsak teden ali na 80 mg vsak drugi teden.
fistula remission3
52. teden remisija fistule3
ASASa partial remission ASDASc inactive disease partial flared a assessment of SpondyloArthritis International Society b baseline is defined as open label baseline when patients have active disease.
International Society b izhodišče je določeno kot izhodišče odprte faze, ko imajo bolniki aktivno bolezen c ocena bolezenske aktivnosti ankilozirajočega spondilitisa (Ankylosing Spondylitis Disease
Hefiya is only available as 40 mg pre-filled syringe and 40 mg pre-filled pen.
Zdravilo Hefiya je na voljo samo v 40 mg napolnjeni injekcijski brizgi in 40 mg napolnjenem injekcijskem peresniku.
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.
Bolniki so prejeli placebo ali adalimumab v začetnem odmerku 80 mg, ki mu je sledil odmerek 40 mg vsak drugi teden, z začetkom dajanja ene teden po začetnem odmerku.
Study UV I evaluated 217 patients with active uveitis despite treatment with corticosteroids (oral prednisone at a dose of 10 to 60 mg / day).
Študija UV I je ovrednotila 217 bolnikov z aktivnim uveitisom kljub zdravljenju s kortikosteroidi
• reproductive tract infections;
• okužbe reproduktivnih organov;
Aortic aneurysm, vascular arterial occlusion, thrombophlebitis
Žilne bolezni pogosti hipertenzija, zardevanje, hematom občasni aortna anevrizma, zapora arterijskega žilja, tromboflebitis
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Ankilozirajoči spondilitis in aksialni spondiloartritis brez radiografskega dokaza za ankilozirajoči spondilitis
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.
Pri bolnikih s Crohnovo boleznijo doseže polnilni odmerek 80 mg adalimumaba na 0. teden, ki mu sledi 40 mg adalimumaba 2. teden, med obdobjem indukcije najmanjšo koncentracijo v serumu približno 5,5 µg/ml.
Doses of 20, 40 or 80 mg of adalimumab or placebo were given every other week for 24 weeks.
Bolniki so 24 tednov vsak drugi teden dobivali odmerke 20, 40 ali 80 mg adalimumaba ali placebo.
clinical remission clinical response * p-value for standard dose versus low dose comparison.
* p vrednost za primerjavo standardnega odmerka proti majhnemu odmerku
• Additional risk minimisation measures The Patient Reminder Cards (adult and paediatric) contain the following key elements:
Opozorilne kartice za bolnika vsebujejo naslednje ključne podatke:
adalimumab 40 mg eow N = 814 n (%)
adalimumab 40 mg vsak 2. teden n = 814 n (%)
Hefiya should be used with caution in patients with mild heart failure (NYHA class I/II).
Pri bolnikih z blagim srčnim popuščanjem (razred I/II po NYHA) je treba zdravilo Hefiya uporabljati previdno.
solution for injection Multipack: 6 (3 packs of 2) pre-filled syringes
raztopina za injiciranje Večkratno pakiranje: 6 napolnjenih injekcijskih brizg (3 pakiranja po 2)
Your doctor may also prescribe an initial dose of 80 mg which may be administered one week prior to the start of the usual dose.
Zdravnik lahko predpiše začetni odmerek 80 mg, ki se uporabi en teden pred začetkom zdravljenja z običajnim odmerkom.
It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems.
da zdravniku poveste, če doživite simptome, kot so npr. zvišana telesna temperatura, rane, občutek utrujenosti ali težave z zobmi.
• Do not touch the cleaned area again before injecting.
• Predela se pred injiciranjem ne dotikajte več.
Liver failure1)
sindrom Guillain-Barré)1)
Each pre-filled syringe contains 40 mg of adalimumab in 0.8 ml of solution.
Ena napolnjena injekcijska brizga vsebuje 40 mg adalimumaba v 0,8 ml raztopine.
Subjects who flared during the double-blind period were allowed adalimumab 40 mg eow rescue therapy for at least 12 weeks.
Preiskovanci, pri katerih je v dvojno slepem obdobju prišlo do ponovnega zagona bolezni, so kot rešilno zdravljenje prejemali adalimumab 40 mg vsak drug teden vsaj 12 tednov.
Children and adolescents with plaque psoriasis
Otroci in mladostniki z luskavico v plakih
Check with your doctor before you receive any vaccines.
da se lahko odločijo, kdaj bo vaš otrok lahko prejel katerokoli cepivo.
In controlled Phase 3 trials of adalimumab in patients with Crohn's disease and ulcerative colitis with a control period ranging from 4 to 52 weeks.
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
There is no relevant use of adalimumab in patients aged less than 2 years for this indication.
Uporaba adalimumaba pri bolnikih, starih manj kot 2 leti, za to indikacijo ni primerna.
SPARCCh MRI sacroiliac jointsd,i SPARCC MRI spined,j a assessment of SpondyloArthritis International Society b
SPARCC MRI hrbtenjačed,j a
Patients received an initial dose of 80 mg adalimumab followed by 40 mg every other week (starting one week after the initial dose) or placebo for 16 weeks.
Bolniki so prejeli začetni odmerek 80 mg adalimumaba, ki mu je sledil 40 mg odmerek ali placebo vsak drugi teden (z začetkom en teden po začetnem odmerku) naslednjih 16 tednov.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF UNIT PACK
ZUNANJA ŠKATLA POSAMIČNEGA PAKIRANJA
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).
Pri 249 pediatričnih bolnikih z juvenilnim idiopatskim artritisom (s poliartikularnim juvenilnim idiopatskim artritisom in artritisom, povezanim z entezitisom), ki so bili med preskušanji adalimumaba zdravilu izpostavljeni 655,6 bolnikov-let, niso ugotovili nobenega malignoma.
Your healthcare provider should show you how to prepare and inject Hefiya properly using the pre-filled syringe before you use it for the first time.
Preden zdravilo Hefiya prvič uporabite, vam mora zdravstveni delavec pokazati, kako ga pravilno pripraviti in injicirati z napolnjeno injekcijsko brizgo.
The recommended Hefiya dose is 80 mg at week 0 followed by 40 mg every other week starting at week 1 via subcutaneous injection.
Priporočeni odmerek zdravila Hefiya je 80 mg v 0. tednu, ki mu sledi 40 mg vsak drugi teden z začetkom v 1. tednu, v obliki subkutane injekcije.
adalimumab 40 mg eow N=108 n (%)
adalimumab 40 mg vsak 2. teden n = 108 n (%)
Pancytopaenia
Pancitopenija
Talk to your doctor or pharmacist before using Hefiya.
Pred začetkom uporabe zdravila Hefiya se posvetujte z zdravnikom ali farmacevtom.
The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a PGA ≥ 4 or > 20 % BSA involvement or > 10 % BSA involvement with very thick lesions or PASI ≥ 20 or ≥ 10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy.
(definirano z zdravnikovo globalno oceno (PGA - Physician's Global Assessment) ≥ 4 ali > 20 % zajete telesne površine ali > 10 % zajete telesne površine z zelo grobimi lezijami ali indeksom obsežnosti in izrazitosti psoriaze (PASI - Psoriasis Area and Severity Index) ≥ 20 ali ≥ 10 s klinično pomembnim zajetjem obraza, genitalij ali dlani/stopal), ki ni bila ustrezno nadzorovana s topikalnim zdravljenjem in helioterapijo ali fototerapijo.
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.
V obdobju A so bolniki prejeli placebo ali adalimumab v začetnem odmerku 160 mg v 0. tednu, nato 80 mg v 2. tednu in 40 mg vsak teden od vključno 4. tedna do 11. tedna.
• shortness of breath;
• hitro zadihanje;
How to store Hefiya
Shranjevanje zdravila Hefiya
Method and route of administration
Način in pot uporabe zdravila
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.
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.
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).
in standardno oskrbo, statistično značilno boljši kot pri bolnikih, zdravljenih s placebom in standardno oskrbo (p < 0,001).
Table 20 paediatric plaque psoriasis efficacy results at 16 weeks
rezultati učinkovitosti v 16. tednu pri pediatričnih bolnikih s psoriazo v plakih
The recommended dose of Hefiya for patients with enthesitis-related arthritis from 6 years of age is based on body weight (table 2).
Priporočeni odmerek zdravila Hefiya pri bolnikih z artritisom, povezanim z entezitisom, starih 6 let in več, temelji na telesni masi (preglednica 2).
Hefiya 40 mg solution for injection in pre-filled syringe adalimumab
Hefiya 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku adalimumab
Tachycardia
• dehidracija
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.
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.
These results suggest that some patients who have not responded by Week 4 benefit from continued maintenance therapy through Week 12.
To kaže, da lahko nadaljnje zdravljenje do 12. tedna koristi nekaterim bolnikom, ki se ne odzovejo do 4. tedna.
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.
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.
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.
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.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TEXT
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
• Only remove the cap when you are ready to use the pen.
• Pokrovček odstranite šele, ko ste pripravljeni za uporabo injekcijskega peresnika.
At 10 years, 79 of 207 patients originally treated with 40 mg adalimumab every other week were evaluated radiographically.
Po 10 letih so rentgenografsko ocenili 79 od 207 bolnikov, ki so bili od začetka zdravljeni s 40 mg adalimumaba vsak drugi teden.
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.
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.
40 mg adalimumab administered every other week c
40 mg adalimumaba vsak drugi teden
Hefiya is contraindicated in moderate to severe heart failure (see section 4.3).
Pri bolnikih z zmernim ali hudim srčnim popuščanjem je zdravilo Hefiya kontraindicirano (glejte poglavje 4.3).
RA Study IIIa**
študija revmatoidnega artritisa IIIa**
Other serious infections seen in clinical trials include pneumonia, pyelonephritis, septic arthritis and septicaemia.
Med drugimi resnimi okužbami, zabeleženimi v kliničnih preskušanjih, so bile pljučnica, pielonefritis,
There is no relevant use of adalimumab in children aged less than 4 years for this indication.
Uporaba adalimumaba pri otrocih, starih manj kot 4 leta, za to indikacijo ni primerna.