natgillin/translations-raw huggingface dataset:
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U
Opportunistic infections, including invasive fungal infections have been observed in patients receiving adalimumab.
Druge oportunističke infekcije U bolesnika koji primaju adalimumab zabilježene su oportunističke infekcije, uključujući invazivne gljivične infekcije.
After 12 weeks of therapy, patients who had received adalimumab in period A were re-randomised in period B to 1 of 3 treatment groups (adalimumab 40 mg every week, adalimumab 40 mg every other week, or placebo from week 12 to week 35).
A primali adalimumab ponovno su randomizirani u razdoblju B u jednu od 3 terapijske skupine (adalimumab u dozi od 40 mg svaki tjedan, adalimumab u dozi od 40 mg svaki drugi tjedan ili placebo od 12. do 35. tjedna).
Hefiya is only available as 40 mg pre-filled syringe and 40 mg pre-filled pen.
Hefiya je dostupan samo kao napunjena štrcaljka od 40 mg i napunjena brizgalica od 40 mg.
Respiratory, thoracic and mediastinal disorders*
Poremećaji dišnog sustava, prsišta i sredoprsja*
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.
Ako ta doza ne djeluje dovoljno dobro, Vaš liječnik može povećati doziranje na 40 mg svaki tjedan ili 80 mg svaki drugi tjedan.
ASASa 20 week 2 week 12 week 24
ASASa 20 2. tjedan 12. tjedan 24. tjedan ASAS 50
• do not shake the syringe.
• ne protresate brizgalicu.
NA
Ako
Choosing your injection site:
Odabir mjesta primjene injekcije:
Patients induced with 160 / 80 mg adalimumab achieved clinical remission versus placebo at week 8 in statistically significantly greater percentages in study UC-I (18 % vs. 9 % respectively, p = 0.031) and study UC-II (17 % vs. 9 % respectively, p = 0.019).
Bolesnici koji su primili indukciju adalimumabom u dozi od 160/80 mg u osmom su tjednu postigli kliničku remisiju u značajno većem postotku u odnosu na placebo i u ispitivanju UC-I (18%,
adalimumab 40 mg weekly N = 70
adalimumab 40 mg svaki tjedan N = 70
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.
U kontroliranim ispitivanjima faze III u kojima se adalimumab primjenjivao u bolesnika s plak psorijazom, s kontrolnim razdobljem koje je trajalo u rasponu od 12 do 24 tjedna, povišenja razine ALT-a ≥ 3 x GGN zabilježena su u 1,8% bolesnika liječenih adalimumabom i 1,8% bolesnika iz kontrolne skupine.
Multipack cartons contain 6 (3 packs of 2) pre-filled pens of Hefiya.
Višestruka pakiranja sadrže 6 (3 pakiranja po 2) napunjenih brizgalica lijeka Hefiya.
Subcutaneous use.
Supkutana primjena.
Children and adolescents from 6 to 17 years of age weighing 40 kg or more
Djeca i adolescenti u dobi od 6 do 17 godina, tjelesne težine 40 kg ili više
The mean trough concentrations were maintained in patients who continued to receive adalimumab treatment eow for 52 weeks.
Srednje vrijednosti najniže koncentracije održale su se u bolesnika koji su nastavili primati adalimumab svaki drugi tjedan kroz 52 tjedna.
• rheumatoid arthritis,
• reumatoidnog artritisa
• low blood measurements for phosphate;
• niska razina fosfata u krvi,
• Sharps disposal container
• Spremnik za odlaganje oštrih predmeta
Patients who had been randomised to placebo in period A were assigned to receive adalimumab 40 mg every week in period B.
A bili randomizirani za primanje placeba je u razdoblju B dodijeljeno liječenje adalimumabom u dozi od 40 mg svaki tjedan.
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.
Adalimumab u dozi od 20 ili 40 mg primjenjivala se ili svaki drugi tjedan naizmjenično s placebom ili svaki tjedan tijekom 26 tjedana;
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.
aksijalnog spondiloartritisa bez radiografskog dokaza ankilozantnog spondilitisa te u bolesnika sa psorijatičnim artritisom iznosi 40 mg adalimumaba, a primjenjuje se kao pojedinačna doza svaka dva tjedna.
No dose-limiting toxicity was observed during clinical trials.
U kliničkim ispitivanjima nisu primijećene toksične reakcije koje bi ograničavale dozu.
(injection) Clear to slightly opalescent, colourless to slightly yellowish solution.
Otopina za injekciju. (injekcija) Bistra do blago opalescentna, bezbojna do blago žućkasta otopina.
Note: treatment failure at or after week 6 (study UV I), or at or after week 2 (study UV II), was counted as event.
115 45 (39,1) NPc Napomena: neuspjeh liječenja u 6. tjednu ili nakon njega (ispitivanje UV I) odnosno u 2. tjednu ili nakon njega (ispitivanje UV II) smatrao se događajem.
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.
Limfomi su se javljali u stopi (interval pouzdanosti 95%) od 0,7 (0,2; 2,7) na 1000 bolesnik- godina u bolesnika liječenih adalimumabom, odnosno u stopi od 0,6 (0,1; 4,5) na 1000 bolesnik- godina u kontrolnoj skupini.
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, are inflammatory diseases of the spine.
Ankilozantni spondilitis i aksijalni spondiloartritis bez radiografskog dokaza ankilozantnog spondilitisa upalne su bolesti kralježnice.
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.
Sve bolesnike, a posebno one koji u anamnezi imaju dugotrajno korištenje imunosupresivne terapije ili bolesnike s psorijazom i PUVA liječenjem u anamnezi, potrebno je prije i za vrijeme liječenja lijekom
• inflammations.
• upale.
At week 4 patients were randomised to 40 mg every other week, 40 mg every week, or placebo with a total study duration of 56 weeks.
U četvrtom tjednu bolesnici su randomizirani u skupine koje su primale 40 mg adalimumaba svaki drugi tjedan, 40 mg adalimumaba svaki tjedan ili placebo kroz ukupno razdoblje ispitivanja od 56 tjedana.
You should record the date when your prefilled pen is first removed from the refrigerator, and the date after which it should be discarded.
Trebate zabilježiti datum kada ste napunjenu brizgalicu prvi put izvadili iz hladnjaka i datum nakon kojeg je trebate baciti.
In adult patients with uveitis, a loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab every other week starting at week 1, resulted in mean steady-state concentrations of approximately 8 to 10 µg/ml.
U odraslih bolesnika s uveitisom, udarna doza adalimumaba od 80 mg u nultom tjednu nakon čega slijedi 40 mg svaki drugi tjedan, počevši od 1. tjedna, dovela je do srednje vrijednosti koncentracija u stanju dinamičke ravnoteže od približno 8 - 10 µg/ml.
Following subcutaneous administration of 40 mg of adalimumab every other week in adult rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 µg / ml (without concomitant methotrexate) and 8 to 9 µg / ml (with concomitant methotrexate), respectively.
Nakon supkutane primjene adalimumaba u dozi od 40 mg svaka dva tjedna u odraslih bolesnika s reumatoidnim artritisom srednje vrijednosti najniže koncentracije lijeka u stanju dinamičke ravnoteže bile su približno 5 μg /ml (bez istodobne primjene metotreksata), odnosno 8 do 9 μg/ml (uz metotreksat).
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.
U kontroliranim ispitivanjima faze III u kojima se adalimumab primjenjivao u bolesnika s reumatoidnim artritisom i psorijatičnim artritisom, s kontrolnim razdobljem koje je trajalo u rasponu od 4 do 104 tjedna, povišenje razine ALT-a ≥3 x GGN (gornja granica normalnog raspona) zabilježeno je u 3,7% bolesnika liječenih adalimumabom i 1,6% bolesnika iz kontrolne skupine.
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.
Nakon dvostruko slijepog dijela ispitivanja slijedio je otvoreni dio ispitivanja u kojem su bolesnici svaki drugi tjedan dobivali 40 mg adalimumaba supkutano kroz dodatna 144 tjedna.
In RA study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for adalimumab / methotrexate combination therapy versus methotrexate monotherapy and adalimumab monotherapy at week 52, which was maintained through week 104.
U ispitivanju RA V, poboljšanje indeksa onesposobljenosti HAQ i fizičke komponente SF 36 nakon 52 tjedna bilo je veće u bolesnika liječenih kombinacijom adalimumaba i metotreksata (p
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.
U ispitivanju CD I, 299 bolesnika koji nikad nisu primali terapiju antagonistima TNF-a randomizirani su u jednu od 4 terapijske skupine: placebo u nultom tjednu i nakon 2 tjedna, 160 mg adalimumaba u nultom tjednu i 80 mg nakon 2 tjedna, 80 mg adalimumaba u nultom tjednu i 40 mg nakon 2 tjedna, 40 mg adalimumaba u nultom tjednu i 20 mg nakon 2 tjedna.
Be sure that you read, understand, and follow these Instructions for Use before injecting Hefiya.
Prije ubrizgavanja lijeka Hefiya morate pročitati, razumjeti i pridržavati se ovih Uputa za uporabu.
Hefiya dose for patients with enthesitis-related arthritis Patient weight
Tablica 2. Doza lijeka Hefiya za bolesnike s artritisom povezanim s entezitisom
At 10 years, 79 of 207 patients originally treated with 40 mg adalimumab every other week were evaluated radiographically.
U 79 od 207 bolesnika koji su uzimali adalimumab 40 mg svaki drugi tjedan učinjena je radiografska kontrola nakon 10 godina.
Pancreatitis, dysphagia, face oedema
Manje često Pankreatitis, disfagija, edem lica
Traceability
OZNAČIVANJE
Preparing the syringe
Priprema štrcaljke
clinical remission clinical response * p-value for standard dose versus low dose comparison.
* p vrijednost za standardnu dozu u usporedbi s niskom dozom.
Hefiya is used to treat ulcerative colitis in adults.
Hefiya je namijenjen liječenju ulceroznog kolitisa u odraslih.
Then take your next dose as you would have on your originally scheduled day, had you not forgotten a dose.
Zatim sljedeću dozu ubrizgajte onog dana kada je to prvotno bilo predviđeno, kao da propusta nije bilo.
low dose 20 / 10 mg eow N = 95
niska doza 20/10 mg svaki drugi tjedan N = 95
On rare occasions, a specific and severe type of lymphoma has been observed in patients taking adalimumab.
U rijetkim je slučajevima u bolesnika koji su uzimali adalimumab uočen specifičan i težak oblik limfoma.
Hefiya dose for paediatric patients with plaque psoriasis Patient weight
Tablica 3. Doza lijeka Hefiya za pedijatrijske bolesnike s plak psorijazom
Adverse events of the haematologic system, including medically significant cytopenia (e.g. thrombocytopenia, leukopenia) have been reported with adalimumab.
U bolesnika liječenih adalimumabom prijavljeni su štetni događaji u hematološkom sustavu, uključujući medicinski značajne citopenije (npr. trombocitopenija, leukopenija).
• double vision;
• dvoslike,
STATEMENT OF ACTIVE SUBSTANCE
NAVOĐENJE DJELATNE TVARI
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.
Nakon slijepog dijela ispitivanja slijedio je otvoreni dio ispitivanja u kojem su bolesnici svaki drugi tjedan dobivali 40 mg adalimumaba supkutano kroz dodatnih 28 tjedana.
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.
Ako je potreban brži odgovor na liječenje, liječnik može propisati početnu dozu od 80 mg (u obliku dvije injekcije od 40 mg u jednom danu) i zatim 40 mg nakon dva tjedna.
At 8 years, 81 of 207 patients originally treated with 40 mg adalimumab every other week were evaluated radiographically.
U 81 od 207 bolesnika koji su uzimali adalimumab 40 mg svaki drugi tjedan učinjena je radiografska kontrola nakon 8 godina.
Idiopathic thrombocytopaenic purpura
Manje često Idiopatska trombocitopenična purpura
Excipients: adipic acid, citric acid monohydrate, sodium chloride, mannitol, polysorbate 80, hydrochloric acid, sodium hydroxide, water for injections.
Pomoćne tvari: adipatna kiselina, citratna kiselina hidrat, natrijev klorid, manitol, polisorbat 80, kloridna kiselina, natrijev hidroksid, voda za injekcije.
The recommended dose of Hefiya for patients with enthesitis-related arthritis from 6 years of age is based on body weight (table 2).
Preporučena doza lijeka Hefiya za bolesnike s artritisom povezanim s entezitisom u dobi od 6 i više godina određuje se na temelju tjelesne težine (tablica 2).
ANNEX II
Tablica 24
Vision related effects were not numerically in favour of adalimumab for colour vision in study UV I and for colour vision, peripheral vision and near vision in study UV II.
Učinci povezani s vidom koji nisu brojčano išli u prilog adalimumabu bili su učinci na vid u boji u ispitivanju UV I, odnosno učinci na vid u boji, periferni vid i vid na blizinu u ispitivanju UV II.
RA study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
Ispitivanje RA III obuhvatilo je 619 bolesnika s umjereno do teško aktivnim reumatoidnim artritisom u dobi
Figure H: insert the needle
Slika H: ubodite iglu
• Merkel cell carcinoma (a type of skin cancer);
• karcinom Merkelovih stanica (vrsta raka kože), • zatajenje jetre,
Adalimumab-treated patients demonstrated statistically significant improvement in physical function as assessed by HAQ and Short Form Health Survey (SF 36) compared to placebo at week 24.
Nakon 24 tjedna u bolesnika liječenih adalimumabom je u odnosu na bolesnike liječene placebom zabilježeno statistički značajno poboljšanje fizičke funkcije, koja se ocjenjivala uz pomoć upitnika HAQ i kratke zdravstvene ankete SF 36.
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.
Liječnik će možda propisati i početnu dozu od 40 mg, koja se može primijeniti tjedan dana prije početka primjene uobičajene doze.
Adalimumab significantly delayed the time to treatment failure, as compared to placebo (See Figure 3, P < 0.0001 from log rank test).The median time to treatment failure was 24.1 weeks for subjects treated with placebo, whereas the median time to treatment failure was not estimable for subjects treated with adalimumab because less than one-half of these subjects experienced treatment failure.
Medijan vremena do neuspjeha liječenja iznosio je 24,1 tjedan u ispitanika koji su primali placebo, dok se u ispitanika liječenih adalimumabom medijan vremena do neuspjeha liječenja nije mogao procijeniti jer je do neuspjeha liječenja došlo u manje od polovice tih ispitanika.
Bath ankylosing spondylitis disease activity index c ankylosing spondylitis disease activity score d mean change from baseline e n=91 placebo and n=87 adalimumab f high sensitivity C-Reactive Protein (mg/L)
C-reaktivni protein visoke osjetljivosti (engl. high sensitivity C-Reactive Protein) (mg/l) g n=73 za placebo i n=70 za adalimumab h Kanadski konzorcij za istraživanje spondiloartritisa (engl.
Hefiya is indicated for treatment of moderately to severely active Crohn's disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Hefiya je indiciran za liječenje umjerenog do teškog oblika aktivne Crohnove bolesti u odraslih bolesnika u kojih unatoč prethodnom potpunom i odgovarajućem tijeku liječenja kortikosteroidima i/ili imunosupresivima nije postignut odgovor ili kod bolesnika koji ih ne podnose ili im je takva terapija kontraindicirana.
• vertigo (sensation of room spinning);
• vrtoglavica (osjećaj da se prostorija vrti),
Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Hefiya.
Za vrijeme liječenja lijekom Hefiya može se nastaviti s davanjem glukokortikoida, salicilata, nesteroidnih protuupalnih lijekova ili analgetika.
The solution should be colourless to slightly yellowish as well as clear to slightly opalescent.
Otopina treba biti bezbojna do blago žućkasta te bistra do blago opalescentna.
Hefiya is used to treat psoriatic arthritis in adults.
Hefiya je namijenjena liječenju psorijatičnog artritisa u odraslih.
• psoriasis,
• psorijaze
Night sweats, scar
Manje često Noćno znojenje, ožiljci
Package leaflet: Information for the patient Hefiya 40 mg solution for injection in pre-filled pen adalimumab
Uputa o lijeku: Informacije za bolesnika Hefiya 40 mg otopina za injekciju u napunjenoj brizgalici adalimumab
Cardiac disorders*
Srčani poremećaji*
Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and psoriatic arthritis
Ankilozantni spondilitis, aksijalni spondiloartritis bez radiografskog dokaza AS-a te psorijatični artritis
In CD study III, 854 patients received open-label 80 mg at week 0 and 40 mg at week 2.
Održavanje kliničke remisije ispitivalo se u ispitivanju CD III (CHARM), u kojem su 854 bolesnika primila 80 mg adalimumaba u nultom tjednu i 40 mg dva tjedna kasnije.
In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with adalimumab and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and adalimumab monotherapy at week 52 and responses were sustained at week 104 (see table 8).
U ispitivanju RA V, u kojem su obuhvaćeni bolesnici u ranoj fazi reumatoidnog artritisa koji do tada nisu bili liječeni metotreksatom, kombiniranom primjenom adalimumaba i metotreksata tijekom 52 tjedna postignut je brži i statistički značajno bolji ACR odgovor nego uz monoterapiju metotreksatom, odnosno adalimumabom.
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.
Hefiya 40 mg otopina za injekciju (injekcija) u napunjenoj brizgalici isporučuje se kao 0,8 ml bistre do blago opalescentne, bezbojne do blago žućkaste otopine.
Common (may affect up to 1 in 10 people)
Često (mogu se javiti u do 1 na 10 osoba)
Thus, it is not possible to administer Hefiya to patients that require less than a full 40 mg dose.
Zato se Hefiya ne može primijeniti u bolesnika koji zahtijevaju manje od cijele doze od 40 mg.
Summary of the safety profile
Health Assessment Questionnaire,
Hefiya 40 mg injection adalimumab SC
Hefiya 40 mg injekcija adalimumab s.c.
In controlled and open label adult and paediatric studies with adalimumab, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis, aspergillosis and listeriosis).
U kontroliranim i otvorenim ispitivanjima adalimumaba u odraslih i djece zabilježene su ozbiljne infekcije (u rijetkim slučajevima i sa smrtnim ishodom), među kojima i tuberkuloza (uključujući njezin milijarni oblik i izvanplućne lokalizacije) te invazivne oportunističke infekcije (npr.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
There is limited safety experience of surgical procedures in patients treated with adalimumab.
Raspoloživi podaci o sigurnosti kirurških zahvata u bolesnika liječenih adalimumabom su ograničeni.
ASAS 50 week 2 week 12 week 24
BASDAIb 50 2. tjedan 12. tjedan 24. tjedan
Polyarticular juvenile idiopathic arthritis
Poliartikularni juvenilni idiopatski artritis
Serious allergic reactions associated with adalimumab were rare during clinical trials.
Tijekom kliničkih ispitivanja rijetko su prijavljivane ozbiljne alergijske reakcije povezane s primjenom adalimumaba.
• vasculitis (inflammation of blood vessels);
• vaskulitis (upala krvnih žila),
Multipack containing 6 (3 packs of 2) pre-filled syringes in a blister Packs of 1 and 2 pre-filled pens
Pakiranja sadrže 1 ili 2 napunjene brizgalice Višestruka pakiranja sadrže 6 (3 pakiranja po 2) napunjenih brizgalica
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.
Psoriasis Area and Severity Index, PASI] ≥ 12 ili ≥ 10) koji su bili kandidati za sistemsku terapiju ili fototerapiju u randomiziranim, dvostruko slijepim ispitivanjima.
Adults with non-infectious uveitis
Odrasli s nezaraznim uveitisom
• low blood measurements for calcium;
• niska razina kalcija u krvi,
10 6336 Langkampfen AUSTRIA
Sandoz GmbH Biochemiestr. 10 6336 Langkampfen AUSTRIJA
Significant improvement of signs of inflammation as measured by hs-CRP and MRI of both Sacroiliac Joints and the Spine was maintained in adalimumab-treated patients through week 156 and week 104, respectively.
C-reaktivnog proteina visoke osjetljivosti (hs-CRP) i MR oslikavanjem i sakroilijakalnih zglobova i kralježnice, održalo se do 156. odnosno 104. tjedna.
Patients who achieved sustained remission for at least 12 weeks (N=305) (ASDAS < 1.3 at weeks 16, 20, 24, and 28) during the open-label period were then randomized to receive either continued treatment with adalimumab 40 mg eow (N=152) or placebo (N=153) for an additional 40 weeks in a double-blind, placebo-controlled period (total study duration 68 weeks).
40 mg svaka dva tjedna (N=152) ili za primanje placeba (N=153) tijekom dodatnih 40 tjedana u dvostruko slijepom, placebom kontroliranom razdoblju (ukupno trajanje ispitivanja: 68 tjedana).
− The other ingredients are adipic acid, citric acid monohydrate, sodium chloride, mannitol, polysorbate 80, hydrochloric acid, sodium hydroxide and water for injections.
Drugi sastojci su adipatna kiselina, citratna kiselina hidrat, natrijev klorid, manitol, polisorbat 80, kloridna kiselina, natrijev hidroksid i voda za injekcije.
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.
U adolescentnih bolesnika u kojih nije postignut zadovoljavajući odgovor na lijek Hefiya u dozi od 40 mg svaki drugi tjedan može se razmotriti povećanje doziranja na 40 mg svaki tjedan ili 80 mg svaki drugi tjedan.
Hefiya can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
U svrhu liječenja teškog, aktivnog i progresivnog reumatoidnog artritisa, Hefiya se može primijeniti i bez prethodnog liječenja metotreksatom.