natgillin/translations-raw huggingface dataset:
There are no clinical trials with adalimumab in adolescent patients with HS.
Adolescentni gnojni hidradenitis Nisu provedena klinička ispitivanja adalimumaba u adolescentnih bolesnika s gnojnim hidradenitisom.
Of the 417 subjects included in the uncontrolled long-term extension of studies UV I and UV II, 46 subjects were regarded ineligible (e.g. developed complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy.
II, 46 ispitanika nije zadovoljavalo kriterije (npr. kod njih su se razvile komplikacije kao posljedica dijabetičke retinopatije, zbog operacije katarakte ili vitrektomije) i stoga nisu bili uključeni u primarnu analizu djelotvornosti.
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).
Preporučena doza lijeka Hefiya za bolesnike s Crohnovom bolešću u dobi od 6 do 17 godina određuje se na temelju tjelesne težine (tablica 4).
Hefiya is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Hefiya je indiciran za liječenje umjerenog do teškog oblika aktivne Crohnove bolesti u pedijatrijskih bolesnika (u dobi od 6 godina i starijih) u kojih nije postignut zadovoljavajući odgovor na konvencionalnu terapiju, uključujući primarnu nutritivnu terapiju i liječenje kortikosteroidom i/ili imunomodulatorom ili u onih koji ne podnose ili u kojih su takve vrste terapija kontraindicirane.
Adalimumab, 40 mg every other week, was studied in patients with moderately to severely active psoriatic arthritis in two placebo-controlled studies, PsA studies I and II.
Djelovanje adalimumaba u dozi od 40 mg svaka dva tjedna ispitivano je u bolesnika s umjereno teškim do teškim aktivnim psorijatičnim artritisom u dva placebom kontrolirana ispitivanja, ispitivanja
Seek medical attention urgently, if you notice any of the following signs of allergic reaction or heart failure:
Primijetite li išta od dolje navedenih znakova alergijske reakcije ili zatajenja srca, hitno zatražite medicinsku pomoć:
These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitisrelated arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients.
(poliartikularnim juvenilnim idiopatskim artritisom i artritisom povezanim s entezitisom), kao i oni s aksijalnim spondiloartritisom (ankilozantnim spondilitisom i aksijalnim spondiloartritisom bez radiografskog dokaza AS-a), psorijatičnim artritisom, Crohnovom bolešću, ulceroznim kolitisom, psorijazom, gnojnim hidradenitisom i uveitisom.
Incorrect
Pravilno Nepravilno
• cutaneous vasculitis (inflammation of blood vessels in the skin);
• kožni vaskulitis (upala krvnih žila u koži),
MARKETING AUTHORISATION NUMBERS
12. BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
Patients received placebo, an initial dose of MTX 7.5 mg and thereafter dose increases up to week 12, with a maximum dose of 25 mg or an initial dose of 80 mg adalimumab followed by 40 mg every other week (starting one week after the initial dose) for 16 weeks.
MTX u početnoj dozi od 7,5 mg, nakon čega se ona povećavala do 12. tjedna do maksimalne doze od 25 mg, ili adalimumab u početnoj dozi od 80 mg, a potom po 40 mg svaki drugi tjedan (počevši tjedan dana nakon početne doze) tijekom 16 tjedana.
Adults with hidradenitis suppurativa
Odrasli s gnojnim hidradenitisom (Hidradenitis suppurativa)
Hefiya is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).
Artritis povezan s entezitisom Hefiya je indiciran za liječenje aktivnog artritisa povezanog s entezitisom u bolesnika u dobi od 6 godina i starijih u kojih nije postignut zadovoljavajući odgovor ili koji ne podnose konvencionalnu terapiju (vidjeti dio 5.1).
Contact your doctor, if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.
Obratite se liječniku ako primijetite simptome kao što su dugotrajan osip nepoznatog uzroka, vrućica, bol u zglobovima ili umor.
The safety and efficacy of adalimumab was assessed in two studies (pJIA I and II) in children with active polyarticular or polyarticular course juvenile idiopathic arthritis, who had a variety of JIA onset types (most frequently rheumatoid-factor negative or positive polyarthritis and extended oligoarthritis).
I i II) u djece s aktivnim poliartikularnim ili poliartikularnim tijekom juvenilnog idiopatskog artritisa i raznim vrstama početka JIA (najčešće negativni reumatoidni faktor ili pozitivni poliartritis i prošireni oligoartritis). pJIA-I
At week 12, a significantly higher proportion of patients treated with adalimumab versus placebo achieved HiSCR.
U 12. tjednu HiSCR je postigao značajno veći udio bolesnika liječenih adalimumabom naspram onih koji su primali placebo.
clinical response clinical remission mucosal healing steroid-free remission for ≥ 90 daysa
klinički odgovor klinička remisija cijeljenje sluznice bolesnici u remisiji bez primjene steroida ≥ 90 danaa
Concurrent administration of biologic DMARDs or TNF-antagonists
Istodobna primjena bioloških antireumatika koji modificiraju tijek bolesti ili antagonista TNF-a
• Tell your doctor if you have lived or travelled in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are common.
• Ako ste boravili ili putovali u predjele u kojima su uobičajene gljivične infekcije kao što su histoplazmoza, kokcidioidomikoza ili blastomikoza, recite to svom liječniku.
Musculoskeletal and connective tissue disorders
Poremećaji mišićno koštanog sustava i vezivnog tkiva
EU/1/18/1287/001 1 pre-filled syringe EU/1/18/1287/002 2 pre-filled syringes
EU/1/18/1287/001 1 napunjena štrcaljka EU/1/18/1287/002 2 napunjene štrcaljke
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.
Bolesnici su bili randomizirani i primali su ili 24 mg/m2 tjelesne površine adalimumaba do maksimalne doze od 40 mg ili placebo svaki drugi tjedan tijekom 12 tjedana.
Reduction of inflammatory lesions and prevention of worsening of abscesses and draining fistulas was assessed using Hidradenitis Suppurativa Clinical Response (HiSCR; at least a 50 % reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to Baseline).
[HiSCR]; smanjenje ukupnog broja apscesa i upalnih nodula za najmanje 50%, bez povećanja broja apscesa i bez povećanja broja drenirajućih fistula u odnosu na početnu vrijednost).
• intestinal perforation (hole in the wall of the gut);
• proboj crijeva (rupa u stijenci crijeva),
In study UC-II, 248 patients received 160 mg of adalimumab at week 0, 80 mg at week 2 and 40 mg eow thereafter, and 246 patients received placebo.
U ispitivanju UC-II, 248 bolesnika primalo je adalimumab u dozi od 160 mg u nultom tjednu, 80 mg u drugom tjednu i zatim 40 mg svaka dva tjedna, a 246 bolesnika primalo je placebo.
EU/1/18/1287/003 6 pre-filled syringes (3 packs of 2)
EU/1/18/1287/003 6 napunjenih štrcaljki (3 pakiranja po 2)
RA study V evaluated 799 methotrexate-naïve, adult patients with moderate to severely active early rheumatoid arthritis (mean disease duration less than 9 months).
Ispitivanje RA V obuhvatilo je 799 odraslih bolesnika s umjereno do teško aktivnim reumatoidnim artritisom (srednja vrijednost trajanja bolesti kraća od 9 mjeseci) koji do tada nisu bili liječeni metotreksatom.
The primary endpoint in RA study V was the percent of patients who achieved an ACR 50 response at week 52.
Primarni ishod ispitivanja RA V bio je postotak bolesnika u kojih je postignut terapijski odgovor
On the basis of clinical trial data in patients with JIA (pJIA and ERA), an exposure-response relationship was established between plasma concentrations and PedACR 50 response.
(poliartikularnim juvenilnim idiopatskim artritisom i artritisom povezanim s entezitisom), utvrđena je veza između plazmatskih koncentracija i odgovora PedACR 50.
Hefiya 40 mg / 0.8 ml injection adalimumab
Hefiya 40 mg / 0,8 ml injekcija adalimumab
• skin infections (including cellulitis and shingles);
• kožne infekcije (uključujući celulitis i herpes zoster),
The usual dose regimen is 40 mg adalimumab initially followed by 20 mg two weeks later.
Uobičajena početna doza adalimumaba je 40 mg, nakon čega poslije dva tjedna slijedi doza od 20 mg.
Thus, it is not possible to use Hefiya for children who require less than a full 40 mg dose.
Zato se Hefiya ne može koristiti u djece koja zahtijevaju manje od cijele doze od 40 mg.
For patients who dose-escalated from eow to weekly regimen, the mean (± SD) serum concentrations of adalimumab at week 52 were 15.3 ± 11.4 μg / ml (40 / 20 mg, weekly) and 6.7 ± 3.5 μg / ml (20 / 10 mg, weekly).
(±SD) koncentracija adalimumaba u serumu u 52. tjednu bile su 15,3 ± 11,4 μg/ml (40/20 mg, tjedno) i 6,7 ± 3,5 μg/ml (20/10 mg, tjedno).
fistula remission3
Tablica 6 Nuspojave
There is little experience from re-administration after more than 8 weeks since the previous dose.
Postoji malo podataka o ponovnoj primjeni lijeka Hefiya kad je prekid terapije trajao duže od 8 tjedana.
Among those, 86 patients (75.4 %) had ACR 20 responses; 72 patients (63.2 %) had ACR 50 responses; and 41 patients (36 %) had ACR 70 responses.
Među njima je njih 86 (75,4%), 72 (63,2%) odnosno 41 (36%) imalo odgovor ACR 20, ACR 50 odnosno ACR 70.
EU/1/18/1287/004 1 pre-filled pen EU/1/18/1287/005 2 pre-filled pens
EU/1/18/1287/004 1 napunjena brizgalica EU/1/18/1287/005 2 napunjene brizgalice
Hefiya is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Hefiya je indiciran za liječenje teškog oblika aktivnog ankilozantnog spondilitisa u odraslih osoba u kojih nije postignut zadovoljavajući odgovor na konvencionalno liječenje.
In adult patients with psoriasis, the mean steady-state trough concentration was 5 µg / ml during adalimumab 40 mg every other week monotherapy treatment.
U odraslih bolesnika sa psorijazom, srednja vrijednost najniže koncentracije u stanju dinamičke ravnoteže bila je 5 μg/ml tijekom primjene monoterapije dozom adalimumaba od 40 mg svaki drugi tjedan.
Hefiya is used to treat rheumatoid arthritis in adults.
Hefiya je namijenjen liječenju reumatoidnog artritisa u odraslih.
Multipack cartons contain 6 (3 packs of 2) pre-filled syringes of Hefiya.
Višestruka pakiranja sadrže 6 (3 pakiranja po 2) napunjenih štrcaljki lijeka Hefiya.
The safety and efficacy of multiple doses of adalimumab were assessed in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopy subscore of 2 to 3) in randomised, double-blind, placebo-controlled studies.
Sigurnost i djelotvornost višestrukih doza adalimumaba ispitivane su u randomiziranim, dvostruko slijepim, placebom kontroliranim kliničkim ispitivanjima u odraslih bolesnika sa srednje teškim do teškim oblikom aktivnog ulceroznog kolitisa (Mayo rezultat od 6 do 12 uz endoskopski podrezultat od 2 do 3).
In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using Hefiya.
Kod nezaraznog uveitisa se uz lijek Hefiya mogu nastaviti primjenjivati kortikosteroidi ili drugi lijekovi koji utječu na imunološki sustav.
• psoriatic arthritis,
• psorijatičnog artritisa
A patient who requires surgery while on Hefiya should be closely monitored for infections, and appropriate actions should be taken.
Bolesnike kojima je za vrijeme liječenja lijekom Hefiya potreban operativni zahvat potrebno je pomno pratiti zbog moguće pojave infekcija i poduzeti odgovarajuće mjere.
Do not use if any particulates and / or discolorations are observed.
Lijek se ne smije koristiti ako su prisutne čestice i/ili promjena boje.
Hefiya is injected under the skin (subcutaneous use).
Hefiya se ubrizgava pod kožu (supkutana primjena).
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.
Vaš liječnik možda će propisati i početnu dozu od 80 mg, koja se može primijeniti tjedan dana prije početka primjene uobičajene doze.
The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3 μg/ml (95% CI: 1-6 μg/ml).
Prividna plazmatska koncentracija adalimumaba uz koju se postiže polovica maksimalne vjerojatnosti za odgovor PedACR 50 (EC50)
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.
U bolesnika s poliartikularnim juvenilnim idiopatskim artritisom, Crohnovom bolešću, ulceroznim kolitisom i gnojnim hidradenitisom primijećeno je naglo smanjenje razina CRP-a nakon liječenja adalimumabom.
These infections have not consistently been recognised in patients taking TNF-antagonists and this has resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes.
TNF-a, što je rezultiralo kašnjenjem s primjerenim liječenjem i ponekad dovelo do smrtnog ishoda.
• When needed (for example when you are travelling), Hefiya may be stored at room temperature (up to 25°C) for a maximum period of 14 days - be sure to protect it from light.
• Kad je to potrebno (na primjer kad putujete), Hefiya se može čuvati na sobnoj temperaturi (do
• enthesitis-related arthritis,
• artritisa povezanog s entezitisom
Following subcutaneous administration of 40 mg of adalimumab every other week in adult nonradiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at week 68 was 8.0 ± 4.6 µg/ml.
Nakon supkutane primjene 40 mg adalimumaba svaki drugi tjedan u odraslih bolesnika s aksijalnim spondiloartritisom bez radiološkog dokaza AS-a, srednja vrijednost (± SD) najniže koncentracije u stanju dinamičke ravnoteže u 68. tjednu iznosila je 8,0 ± 4,6 µg/ml.
There is no relevant use of Hefiya in children aged less than 2 years in this indication.
Nema relevantne primjene lijeka Hefiya u djece mlađe od 2 godine u ovoj indikaciji.
Your doctor should test you for HBV. Adalimumab can reactivate HBV infection in people who carry this virus.
Adalimumab može u nositelja virusa reaktivirati HBV infekciju.
You may also use the lower abdomen, but not the area 5 cm around your navel (belly button) (see Figure E).
Možete koristiti i donji dio trbuha, ali ne područje 5
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BRIZGALICI
Hefiya should be used with caution in patients with mild heart failure (NYHA class I/II).
. Zato se bolesnicima s blagim zatajenjem srca (NYHA razred I/II) Hefiya mora davati oprezno.
Axial spondyloarthritis without radiographic evidence of AS
Aksijalni spondiloartritis bez radiografskog dokaza AS-a
≥30% reduction in skin painb
smanjenje kožne boli za
PsA study I with 24 week duration, treated 313 adult patients who had an inadequate response to non-steroidal antiinflammatory drug therapy and of these, approximately 50 % were taking methotrexate.
Ispitivanjem PsA I u trajanju od 24 tjedna obuhvaćeno je 313 odraslih bolesnika koji nisu ostvarili odgovarajući odgovor na prethodno liječenje nesteroidnim protuupalnim lijekovima.
Injection site reactions generally did not necessitate discontinuation of the medicinal product.
Liječenje obično nije trebalo prekidati zbog reakcija na mjestu primjene.
ACR responses in PsA study I were similar with and without concomitant methotrexate therapy.
ACR odgovori bolesnika u ispitivanju PsA I bili su slični neovisno o tome jesu li istodobno dobivali metotreksat ili nisu.
Ear and labyrinth disorders
Poremećaji uha i labirinta Često
In controlled Phase 3 trials of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations ≥ 3 x ULN occurred in 6.1 % of adalimumab-treated patients and 1.3 % of control-treated patients.
U kontroliranim ispitivanjima faze III u kojima se adalimumab primjenjivao u bolesnika u dobi od 4 do 17 godina s poliartikularnim juvenilnim idiopatskim artritisom i u bolesnika u dobi od 6 do 17 godina s artritisom povezanim s entezitisom, povišenje ALT-a ≥ 3 x GGN zabilježeno je u 6,1% bolesnika liječenih adalimumabom i 1,3% bolesnika iz kontrolne skupine.
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.
Zloćudne bolesti nisu primijećene u 60 pedijatrijskih bolesnika s izloženošću od 58,4 bolesnik-godina u ispitivanju adalimumaba provedenom u pedijatrijskih bolesnika s uveitisom.
Injection site reaction (including injection site erythema)
Vrlo često Reakcije na mjestu primjene (uključujući eritem na mjestu primjene)
Figure F: remove the cap
Slika F: uklonite zatvarač
If you do not respond well enough to these medicines, you will be given Hefiya to reduce the signs and symptoms of your Crohn's disease.
Ako na njih ne odgovorite dovoljno dobro, dobit ćete lijek Hefiya kako bi se smanjili simptomi i znakovi Vaše bolesti.
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.
Bolesnici su primili adalimumab u početnoj dozi od 80 mg, a potom po 40 mg svaki drugi tjedan (počevši tjedan dana nakon početne doze) ili placebo tijekom 16 tjedana.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF UNIT PACK
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
• 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.
• U bolesnika koji boluju od specifične plućne bolesti koja se naziva kronična opstruktivna plućna bolest (KOPB) i primali su neke druge TNFα blokatore, zabilježeni su i drugačiji oblici raka, osim limfoma.
Cartons contain 1 and 2 pre-filled pens of Hefiya.
Kutije sadrže 1 ili 2 napunjene štrcaljke lijeka Hefiya.
A total of 76.5 % (218 / 285) of patients who entered the retreatment period had a response of PGA “clear” or “minimal” after 16 weeks of retreatment, irrespective of whether they relapsed during withdrawal (69.1 % [123 / 178] and 88.8 % [95 / 107] for patients who relapsed and who did not relapse during the withdrawal period, respectively).
Ukupno je 76,5% (218/285) bolesnika kojima je liječenje ponovno uvedeno imalo PGA odgovor “bez bolesti” ili “minimalno” nakon 16 tjedana liječenja, bez obzira jesu li doživjeli relaps u razdoblju kada je liječenje bilo ukinuto
Hefiya is administered by injection under the skin (by subcutaneous injection).
Hefiya se primjenjuje injekcijom pod kožu (supkutanom injekcijom).
EU/1/18/1287/006 6 pre-filled pens (3 packs of 2)
EU/1/18/1287/006 6 napunjenih brizgalica (3 pakiranja po 2)
Among those, 64 patients (79.0 %) had ACR 20 responses; 56 patients (69.1 %) had ACR 50 responses; and 43 patients (53.1 %) had ACR 70 responses.
Među njima je njih 64 (79,0%), 56 (69,1%), odnosno 43 (53,1%) imalo odgovor ACR 20, ACR 50 odnosno ACR 70.
Patient reported outcomes regarding vision-related functioning were measured in both clinical studies, using the NEI VFQ-25.
U oba su se klinička ispitivanja upitnikom NEI VFQ-25 određivali ishodi s obzirom na funkcioniranje povezano s vidom koje su prijavljivali bolesnici.
• Do not freeze your pen.
• Ne zamrzavati brizgalicu.
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.
Nakon dvostruko slijepog razdoblja uslijedilo je otvoreno razdoblje tijekom kojeg su bolesnici primali 24 mg/m2 tjelesne površine adalimumaba do maksimalne doze od 40 mg svaki drugi tjedan supkutano tijekom najviše 192 dodatna tjedna.
• reproductive tract infections;
• infekcije reproduktivnih organa,
• lichenoid skin reaction (itchy reddish-purple skin rash).
• angioedem (lokalizirano oticanje kože), • lihenoidne kožne reakcije (crvenkasto-ljubičasti kožni osip koji svrbi).
10 A-6250 Kundl Austria
Sandoz GmbH Biochemiestr. 10 A-6250 Kundl Austrija
Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
6.1 Popis pomoćnih tvari adipatna kiselina citratna kiselina hidrat natrijev klorid manitol polisorbat 80 kloridna kiselina (za podešavanje pH) natrijev hidroksid (za podešavanje pH) voda za injekcije
Hefiya is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Hefiya je indiciran za liječenje kroničnog neinfektivnog anteriornog uveitisa u djece u dobi od 2 godine i starije u koje nije postignut zadovoljavajući odgovor na konvencionalno liječenje, koji ne podnose konvencionalno liječenje ili u kojih konvencionalno liječenje nije prikladno.
The recommended Hefiya dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (table 3).
Preporučena doza lijeka Hefiya za bolesnike s plak psorijazom u dobi od 4 do 17 godina određuje se na temelju tjelesne težine (tablica 3).
• sensation disorders such as tingling, prickling or numbness;
• poremećaj osjeta kao što su trnci, bockanje ili utrnulost,
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.
U ispitivanju CD II, 325 bolesnika koji su izgubili odgovor ili nisu podnosili terapiju infliksimabom randomizirani su u dvije skupine: jedna je primila 160 mg adalimumaba u nultom tjednu i 80 mg adalimumaba dva tjedna kasnije, a druga skupina je primila placebo u nultom tjednu i 2. tjednu.
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.
Kod primjene adalimumaba također su prijavljene infekcije sa smrtnim ishodom i po život opasne infekcije (uključujući sepsu, oportunističke infekcije i tuberkulozu), reaktivacija HBV-a i razne zloćudne bolesti (uključujući leukemiju, limfom i hepatosplenični T-stanični limfom).
The safety and efficacy of adalimumab were assessed in a multicentre, randomised, double-blind, parallel-group study in 171 children (4-17 years old) with polyarticular JIA.
dvostruko-slijepom ispitivanju s paralelnim skupinama koje je uključivalo 171 dijete (u dobi od 4-17 godina) s poliartikularnim JIA.
Hefiya 40 mg solution for injection in pre-filled syringe Hefiya 40 mg solution for injection in pre-filled pen
Hefiya 40 mg otopina za injekciju u napunjenoj štrcaljki Hefiya 40 mg otopina za injekciju u napunjenoj brizgalici
You should record the date when your prefilled syringe is first removed from the refrigerator, and the date after which it should be discarded.
Trebate zabilježiti datum kada ste napunjenu štrcaljku prvi put izvadili iz hladnjaka i datum nakon kojeg je trebate baciti.
Induction dose
Indukcijska doza
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
• aksijalnog spondiloartritisa bez radiografskog dokaza ankilozantnog spondilitisa