natgillin/translations-raw huggingface dataset:
In CD Study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg adalimumab at week 0 and 80 mg at week 2 or placebo at Weeks 0 and 2.
V študiji pri Crohnovi bolezni II so 325 bolnikov, ki so se nehali odzivati na infliksimab ali ga niso prenesli, randomizirali bodisi na 160 mg adalimumaba 0. teden in 80 mg 2. teden bodisi na placebo 0. in 2. teden.
Patients demonstrating a paediatric ACR 30 response at week 16 were eligible to be randomised into the double blind (DB) phase and received either adalimumab 24 mg / m2 up to a maximum of 40 mg, or placebo every other week for an additional 32 weeks or until disease flare.
Bolniki, ki so 16. teden dosegli odziv »pediatric ACR« 30, so bili primerni za randomizacijo v dvojno slepo fazo in so nadaljnjih 32 tednov ali do zagona bolezni vsak drugi teden dobili adalimumab 24 mg/m2 (do največ 40 mg) ali placebo.
The safety and efficacy of adalimumab were also studied in adult patients with moderate to severe chronic plaque psoriasis with concomitant hand and / or foot psoriasis who were candidates for systemic therapy in a randomised double-blind study (Psoriasis Study III).
Varnost in učinkovitost adalimumaba so raziskali tudi v randomizirani dvojno slepi študiji pri odraslih bolnikih z zmerno do hudo kronično psoriazo v plakih s sočasno psoriazo na dlaneh in/ali stopalih, ki so bili kandidati za sistemsko zdravljenje (Študija pri psoriazi III).
It is only available as 40 mg pre-filled syringe and / or as 40 mg pre-filled pen.
Na voljo je samo v 40 mg napolnjeni injekcijski brizgi in/ali 40 mg napolnjenem injekcijskem peresniku.
Table 4.
Preglednica 4.
Do not re-use a syringe.
Injekcijske igle ne uporabite ponovno.
discontinuation of Immunomodulators2
26. teden 52. teden prenehanje z imunomodulatorji2
The recommended dose of Hefiya for patients with Crohn's disease from 6 to 17 years of age is based on body weight (table 4).
Priporočeni odmerek zdravila Hefiya pri bolnikih s Crohnovo boleznijo, starih od 6 do 17 let, temelji na telesni masi (preglednica 4).
Adalimumab Δ Censored
Placebo adalimumab Δ anonimizirano
12 months
6 mesecev 12 mesecev
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
• aksialnega spondiloartritisa brez radiografskega dokaza za ankilozirajoči spondilitis,
• Do not give Hefiya to children with paediatric plaque psoriasis or paediatric ulcerative colitis below the age of 4 years.
• Zdravila Hefiya ne smete dati otroku z luskavico v plakih ali ulceroznim kolitisom, če je star manj kot 4 leta.
Serious allergic reactions associated with adalimumab were rare during clinical trials.
Alergijske reakcije V kliničnih študijah so bile redke resne alergijske reakcije, povezane z adalimumabom.
If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your doctor immediately.
Če se med zdravljenjem ali po njem pojavijo simptomi tuberkuloze (trdovraten kašelj, hujšanje, brezvoljnost, rahlo zvišana telesna temperatura) ali kakšne druge okužbe, to takoj povejte zdravniku.
Table 10 radiographic mean changes at week 52 in RA study V
Preglednica 10 povprečne rentgenografske spremembe po 52 tednih študije revmatoidnega artritisa V
The double-blind period was followed by an openlabel period during which patients receive adalimumab 40 mg every other week subcutaneously for up to an additional 144 weeks.
Dvojno slepi periodi je sledila odprta perioda, v kateri so bolniki prejemali adalimumab 40 mg vsak drug teden subkutano do dodatnih 144 tednov.
• There have been very rare cases of certain kinds of cancer in children and adults taking adalimumab or other TNFα blockers.
Rak • Med otroki in odraslimi, ki so jemali adalimumab ali druge zaviralce TNFα, so se pojavili zelo redki primeri določenih vrst raka.
Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, and for patients with psoriatic arthritis is 40 mg adalimumab given every other week as a single dose.
Odrasli z revmatoidnim artritisom, psoriatičnim artritisom, ankilozirajočim spondilitisom ali aksialnim spondiloartritisom brez radiografskega dokaza za ankilozirajoči spondilitis odmerek za odrasle z revmatoidnim artritisom, ankilozirajočim spondilitisom, aksialnim spondiloartritisom brez radiografskega dokaza za ankilozirajoči spondilitis in za bolnike s psoriatičnim artritisom je 40 mg adalimumaba vsaka dva tedna v enkratnem odmerku.
Patients were randomised to receive either 24 mg / m2 body surface area (BSA) of adalimumab up to a maximum of 40 mg, or placebo every other week for 12 weeks.
Bolniki so bili randomizirani za prejemanje bodisi 24 mg/m2 telesne površine adalimumaba do največjega posamičnega odmerka 40 mg ali placebo vsak drugi teden, 12 tednov.
• do not remove the needle cap until just before you give the injection.
• ne odstranite pokrovčka za iglo, dokler niste tik pred injiciranjem.
Cardiac disorders*
Srčne bolezni*
Therefore, caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with increased risk for malignancy due to heavy smoking.
Zato je treba pri bolnikih s KOPB in bolnikih, ki jih zaradi hudega kajenja bolj ogroža malignom, vsak antagonist TNF uporabljati previdno.
• hepatitis (liver inflammation);
• hepatitis (vnetje jeter);
• There have been cases of cancers, other than lymphoma, in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another TNFα blocker.
• Pri bolnikih s posebno boleznijo pljuč, t.i. kronično obstruktivno pljučno boleznijo (KOPB), zdravljenih z nekim drugim zaviralcem TNFα, so bili primeri rakov, ki niso bili limfomi.
• You may see a few drops of liquid come out of the needle.
• Iz igle bo morda prišla kapljica tekočine.
At week 12, a significantly higher proportion of patients treated with adalimumab versus placebo achieved HiSCR.
V 12. tednu je statistično pomembno večji delež bolnikov, ki so prejemali adalimumab, doseglo klinični odziv (HiSCR) v primerjavi z bolniki, ki so prejemali placebo.
Figure D: choose your injection site
Slika D: Izberite mesto injiciranja
The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥ 10 % BSA involvement and Psoriasis Area and Severity Index (PASI) ≥ 12 or ≥ 10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Varnost in učinkovitost adalimumaba so v randomiziranih, dvojno slepih študijah raziskali pri odraslih bolnikih s kronično psoriazo v plakih (zajete ≥ 10 % telesne površine ter indeksom obsežnosti in izrazitosti psoriaze (PASI - Psoriasis Area and Severity Index) ≥ 12 ali ≥ 10), ki so bili kandidati za sistemsko zdravljenje ali fototerapijo.
Psoriatic arthritis is an inflammatory disease of the joints associated with psoriasis.
Psoriatični artritis je vnetna bolezen sklepov, povezana s kožno luskavico.
In patients with polyarticular JIA who were 2 to < 4 years old or aged 4 and above weighing < 15 kg dosed with adalimumab 24 mg / m2, the mean trough steady-state serum adalimumab concentrations was 6.0 ± 6.1 µg / ml (101 % CV) for adalimumab without concomitant methotrexate and 7.9 ± 5.6 µg / ml (71.2 % CV) with concomitant methotrexate.
Pri bolnikih s poliartikularnim JIA, starih od 2 do < 4 leta ali starih 4 leta ali več in s telesno maso < 15 kg, ki so prejemali adalimumab v odmerku 24 mg/m2, je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja 6,0 ± 6,1 µg/ml (KV 101 %) med uporabo adalimumaba brez metotreksata in 7,9 ± 5,6 µg/ml (KV 71,2 %) med sočasno uporabo metotreksata.
• polyarticular juvenile idiopathic arthritis,
• poliartikularnega juvenilnega idiopatskega artritisa,
• Keep your pen in the original carton until ready to use to protect from light.
• Injekcijski peresnik hranite v originalni ovojnini, dokler ni pripravljen za uporabo, da ga zaščitite pred svetlobo.
Overall responses were generally better and, fewer patients developed antibodies when treated with the combination of adalimumab and MTX compared to adalimumab alone.
Celotni odzivi so bili med zdravljenjem s kombinacijo adalimumaba in metotreksata na splošno boljši in pri manj bolnikih so se pojavila protitelesa kot med zdravljenjem z adalimumabom samim.
• sensation of heart beating irregularly such as skipped beats;
• občutek neenakomernega bitja srca kot je preskakovanje utripov;
Continued therapy beyond 16 weeks should be carefully considered in a patient not responding within this time period.
O neprekinjenem zdravljenju po 16. tednu je treba skrbno premisliti pri bolniku, ki se v tem obdobju ni odzval na zdravljenje.
Among those, 48 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less.
Med temi bolniki jih 48 ni kazalo napredovanja strukturne prizadetosti izražene s spremembo srednje celotne Sharpove ocene 0,5 ali manj od začetka študije.
A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded.
Pri otrocih in mladostnikih, zdravljenih z antagonisti TNF, ni mogoče izključiti tveganja nastanka malignomov.
Following the administration of 0.8 mg / kg (up to a maximum of 40 mg) subcutaneously every other week to paediatric patients with chronic plaque psoriasis, the mean ± SD steady-state adalimumab trough concentration was approximately 7.4 ± 5.8 µg / ml (79 % CV).
Po dajanju adalimumaba 0,8 mg/kg (do največ 40 mg) subkutano vsak drugi teden pediatričnim bolnikom s kronično psoriazo v plakih, je bila povprečna (±SD) najmanjša koncentracija adalimumaba v stanju dinamičnega ravnovesja približno 7,4± 5,8 µg/ml (79 % KV).
Bath ankylosing spondylitis disease activity index
b Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa (Bath Ankylosing
Of 207 patients who were randomised to adalimumab 40 mg every other week, 114 patients continued on adalimumab 40 mg every other week for
Od 207 bolnikov, ki so bili randomizirani na adalimumab 40 mg vsak drugi teden, jih je 114 nadaljevalo zdravljenje z adalimumabom 40 mg vsak drugi teden še 5 let.
• breaking of finger nails and toe nails;
• lomljivost nohtov na rokah in nogah;
Patients who were in the non-MTX stratum were either naïve to or had been withdrawn from MTX at least two weeks prior to study drug administration.
Bolniki v stratumu brez metotreksata le-tega sploh še niso dobivali ali so ga nehali dobivati vsaj dva tedna pred uporabo raziskovanega zdravila.
Figure G: pull the needle cap off
Slika G: Odstranite pokrovček z igle
Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis)1), urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia1), pruritus
pogosti poslabšanje ali pojav psoriaze (vključno s palmplantarno pustularno psoriazo)1) urtikarija,
Infections
Okužbe
The rate (95 % confidence interval) of lymphomas was 0.7 (0.2, 2.7) per 1,000 patient years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient years among control patients.
Delež (95 % interval zaupanja) limfomov je bil 0,7 (0,2; 2,7) na 1000 bolnikov let med bolniki, ki so dobivali adalimumab, in 0,6 (0,1; 4,5) na 1000 bolnikov let v kontrolni skupini bolnikov.
Children, adolescents and adults with polyarticular juvenile idiopathic arthritis Children, adolescents and adults from 2 years of age weighing 30 kg or more The recommended dose of Hefiya is 40 mg every other week.
Otroci, mladostniki in odrasli s poliartikularnim juvenilnim idiopatskim artritisom Otroci, mladostniki in odrasli, starejši od 2 let, ki tehtajo 30 kg ali več Priporočeni odmerek zdravila Hefiya je 40 mg vsak drugi teden.
ACR 20 week 12 week 24 ACR 50 week 12 week 24 ACR 70 week 12 week 24
ASASa 20 2. teden 12. teden 24. teden ASAS 50 2. teden 12. teden 24. teden ASAS 70 2. teden 12. teden 24. teden
Hepatitis reactivation of hepatitis B1) autoimmune hepatitis1)
jetrna steatoza, zvišana vrednost bilirubina v krvi redki hepatitis reaktivacija hepatitisa B1) avtoimunski hepatitis1)
b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab / methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Vrednost p se nanaša na parno primerjavo monoterapije z metotreksatom in kombinirane terapije z adalimumabom/metotreksatom z Mann-Whitneyevim testom U. b Vrednost p se nanaša na parno primerjavo monoterapije z adalimumabom in kombinirane terapije z adalimumabom /metotreksatom z Mann-Whitneyevim testom U.
Disease-related hospitalisations and surgeries were statistically significantly reduced with adalimumab compared with placebo at week 56.
boleznijo povezanih hospitalizacij in operacij je bilo do 56. tedna med uporabo adalimumaba statistično značilno manj kot med uporabo placeba.
ACR 20 week 52 62.6 % 54.4 % 72.8 % 0.013 < 0.001 0.043 week 104 56.0 % 49.3 % 69.4 % 0.002 < 0.001 0.140 ACR 50 week 52 45.9 % 41.2 % 61.6 % < 0.001 < 0.001 0.317 week 104 42.8 % 36.9 % 59.0 % < 0.001 < 0.001 0.162 ACR 70 week 52 27.2 % 25.9 % 45.5 % < 0.001 < 0.001 0.656 week 104 28.4 % 28.1 % 46.6 % < 0.001 < 0.001 0.864
52. teden 45,9 % 41,2 % 61,6 % 104. teden 42,8 % 36,9 % 59,0 % ACR 70
Rare post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with adalimumab (see section 4.4).
V redkih primerih med obdobjem trženja so pri bolnikih, zdravljenih z adalimumabom, poročali o hepatospleničnem limfomu celic T (glejte poglavje 4.4).
PGA: clear / minimal
PGA: čisto/minimalnoc a
Figure F: clean your injection site
Slika F: Očistite mesto injiciranja
EU/1/18/1287/003 6 pre-filled syringes (3 packs of 2)
EU/1/18/1287/003 6 napolnjenih injekcijskih brizg (3 pakiranja po 2)
Hefiya is used to treat rheumatoid arthritis in adults.
Zdravilo Hefiya se uporablja za zdravljenje revmatoidnega artritisa pri odraslih.
Table 27 paediatric CD study discontinuation of corticosteroids or immunomodulators and fistula remission standard dose 40 / 20 mg eow low dose 20 / 10 mg eow p value1
študija Crohnove bolezni pri pediatričnih bolnikih prenehanje zdravljenja s kortikosteroidi ali imunomodulatorji in remisija fistule standardni odmerek 40/20 mg vsak drugi teden nizek odmerek 20/10 mg vsak drugi teden p vrednost1
Rare (may affect up to 1 in 1,000 people)
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov)
In controlled trials of adalimumab (initial doses of 80 mg at week 0 followed by 40 mg every other week starting at week 1) in adult patients with uveitis up to 80 weeks with a median exposure of 166.5 days and 105.0 days in adalimumab-treated and control-treated patients, respectively, ALT elevations ≥ 3 x ULN occurred in 2.4 % of adalimumab-treated patients and 2.4 % of control-treated patients.
V kontroliranih preskušanjih z adalimumabom (začetni odmerek 80 mg v 0. tednu, ki mu sledi odmerek 40 mg vsak drugi teden z začetkom v 1. tednu) pri odraslih bolnikih z uveitisom, ki so trajala do 80 tednov, z mediano izpostavljenostjo 166,5 dni pri bolnikih, zdravljenih adalimumabom in 105,0 dni pri bolnikih v kontrolni skupini, se je zvišanje ALT ≥ 3 x ULN pojavilo pri 2,4 %
Hefiya 40 mg solution for injection in a single-use pre-filled syringe Hefiya is supplied in a single-use clear type I glass syringe with a rubber stopper and a stainless steel needle with an automatic needle guard with finger flange, rubber needle cap and plastic plunger, containing 0.8 ml solution.
Hefiya 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi za enkratno uporabo Zdravilo Hefiya je na voljo v napolnjeni injekcijski brizgi za enkratno uporabo iz prozornega stekla tipa I z gumijasto zaporko in z iglo iz nerjavečega jekla z avtomatskim ščitnikom za iglo z držalom, z gumijastim pokrovčkom za iglo in s plastičnim batom, ki vsebuje 0,8 ml raztopine.
You should record the date when your prefilled syringe is first removed from the refrigerator, and the date after which it should be discarded.
Zapisati si morate datum, ko je bila napolnjena injekcijska brizga vzeta iz hladilnika, in datum, po katerem jo je treba zavreči.
Similar remission rates were observed for the 160 / 80 mg and 80 / 40 mg induction regimens by week 8 and adverse events were more frequently noted in the 160 / 80 mg group.
Z indukcijskima shemama 160/80 mg in 80/40 mg so do 8. tedna ugotovili podobne deleže remisij;
CD study I and CD study II induction of remission and response rates are presented in table 23.
Indukcijo remisije in deleže odziva v študiji pri Crohnovi bolezni I in študiji pri Crohnovi bolezni II prikazuje preglednica 23.
The recommended dose of Hefiya for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Priporočeni odmerek zdravila Hefiya za odrasle bolnike z revmatoidnim artritisom je 40 mg adalimumaba vsak drugi teden v enkratnem odmerku v subkutani injekciji.
Pulmonary fibrosis1)
Neželeni učinki redki pljučna fibroza1)
Axial spondyloarthritis without radiographic evidence of AS
Aksialni spondiloartritis brez radiografskega dokaza za AS
Of those patients who had a response at week 8, 47 % were in response, 29 % were in remission, 41 % had mucosal healing, and 20 % were in steroid-free remission for ≥ 90 days at week 52.
Od bolnikov, ki so bili odzivni v 8. tednu, jih je bilo v 52. tednu 47 % odzivnih, 29 % v remisiji, 41 %
• It is important that you tell your baby's doctors and other health care professionals about your Hefiya use during your pregnancy before the baby receives any vaccine (for more information on vaccines see the “Warnings and precautions” section).
• Pomembno je, da obvestite zdravnika vašega dojenčka in druge zdravstvene delavce, da ste med nosečnostjo prejemali zdravilo Hefiya, preden bo vaš dojenček prejel katerokoli cepivo.
INSTRUCTIONS ON USE
Navodila za uporabo
Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been reported with use of adalimumab.
V zvezi z uporabo adalimumaba so poročali tudi o smrtnih in življenjsko ogrožajočih okužbah (vključno s sepso, oportunističnimi okužbami in TB), HBV reaktivaciji in različnih malignih obolenjih (vključno z levkemijo, limfomom in HSTCL).
In controlled Phase 3 trials of adalimumab in patients with plaque Psoriasis with a control period duration ranging from 12 to 24 weeks, ALT elevations ≥ 3 x ULN occurred in 1.8 % of adalimumabtreated patients and 1.8 % of control-treated patients.
V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih s psoriazo s plaki in s trajanjem kontrolnega obdobja od 12 do 24 tednov, se je zvišanje ALT ≥ 3 x ULN pojavilo pri 1,8 % bolnikov, zdravljenih z adalimumabom, in pri 1,8 % bolnikov v kontrolni skupini.
Hefiya is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Zdravilo Hefiya je indicirano za zdravljenje zmerno do hudo aktivnega ulceroznega kolitisa pri odraslih bolnikih, ki so se ne odzovejo zadostno na običajno zdravljenje, na primer na kortikosteroide in 6-merkaptopurin (6-MP) ali azatioprin (AZA), ali pa takšnega zdravljenja ne prenesejo oz. imajo zanj medicinske kontraindikacije.
• erythema multiforme (inflammatory skin rash);
• multiformni eritem (vnetje kožnega izpuščaja);
Reports of serious allergic reactions including anaphylaxis have been received following adalimumab administration.
Po uporabi adalimumaba so prejeli poročila o resnih alergijskih reakcijah, vključno z anafilaksijo.
Do not re-use the pen.
Pokrovčka ne skušajte ponovno pritrditi.
In the OL LI phase all patients received 24 mg / m2 up to a maximum of 40 mg adalimumab every other week for 16 weeks.
V odprti uvajalni fazi so vsi bolniki 16 tednov dobivali 24 mg/m2 (do največ 40 mg) adalimumaba vsak drugi teden.
Treatment failure was defined by a multi-component outcome based on inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber (AC) cell grade, vitreous haze (VH) grade and best corrected visual acuity (BCVA).
Neuspeh zdravljenja je bil definiran z večkomponentnim izidom, ki je temeljil na vnetnih horioretinalnih in/ali vnetnih retinalnih vaskularnih lezijah, oceni celic sprednje očesne komore,
A rapid decrease in CRP levels was also observed in patients with polyarticular juvenile idiopathic arthritis, Crohn's disease, ulcerative colitis and hidradenitis suppurativa after treatment with adalimumab.
Pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, Crohnovo boleznijo, ulceroznim kolitisom in hidradenitis suppurativa so opazili tudi naglo znižanje koncentracij CRP po zdravljenju z adalimumabom.
Skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma) benign neoplasm
pogosti karcinom kože, ki ne vključuje malignega melanoma (vključno z bazalnoceličnim karcinomom in ploščatoceličnim karcinomom,)
2D barcode carrying the unique identifier included.
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
Table 14 efficacy response in placebo-controlled study nr-axSpA I
odziv učinkovitosti v s placebom kontrolirani študiji nr-axSpA I
Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and psoriatic arthritis
Ankilozirajoči spondilitis, aksialni spondiloartritis brez radiografskega dokaza za AS in psoriatični artritis
The recommended dose of Hefiya for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Priporočeni odmerek zdravila Hefiya pri bolnikih z ankilozirajočim spondilitisom, aksialnim spondiloartritisom brez radiografskega dokaza za AS in pri bolnikih s psoriatičnim artritisom je 40 mg adalimumaba, apliciran v enkratni subkutani injekciji vsak drugi teden.
• vision disturbances;
• motnje vida;
Hefiya is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen (SensoReady) with transparent window and label.
Zdravilo Hefiya je na voljo v injekcijski brizgi za enkratno uporabo, v injekcijskem peresniku trikotne oblike (SensoReady), s prozornim okencem in oznako.
Figure K: slowly release the plunger
Slika K: Počasi spuščajte bat
All doses / schedules of adalimumab in all four studies showed statistically significantly greater improvement in the disability index of the HAQ from baseline to Month 6 compared to placebo and in RA study III the same was seen at week 52.
V vseh štirih študijah se je indeks invalidnosti po vprašalniku HAQ od izhodišča do 6. meseca z vsemi odmerki/shemami adalimumaba izboljšal statistično značilno bolj kot s placebom; v študiji revmatoidnega artritisa III so isto ugotovili po 52 tednih.
RA Study IIa**
študija revmatoidnega artritisa IIa**
• Take the syringe out of the blister.
• Injekcijsko brizgo vzemite iz pretisnega omota.
There is limited safety experience of surgical procedures in patients treated with adalimumab.
Izkušnje z varnostjo operacij pri bolnikih, zdravljenih z adalimumabom, so omejene.
Thus, it is not possible to administer Hefiya to patients that require less than a full 40 mg dose.
Zato zdravila Hefiya ni mogoče dajati bolnikom, ki potrebujejo odmerek, manjši od 40 mg.
In adult Crohn's disease studies, higher incidences of malignant and serious infection-related adverse events were seen with the combination of adalimumab and azathioprine / 6-mercaptopurine compared with adalimumab alone.
V študijah Crohnove bolezni pri odraslih so pri sočasni uporabi adalimumaba in azatioprina/6