natgillin/translations-raw huggingface dataset:
Cartons contain 1 and 2 pre-filled syringes of Hefiya.
Škatle vsebujejo 1 in 2 napolnjeni injekcijski brizgi zdravila Hefiya.
Contact your doctor, if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.
Obvestite svojega zdravnika, če se pojavijo simptomi, kot so vztrajen nepojasnjen izpuščaj, zvišana telesna temperatura, bolečine v sklepih ali utrujenost.
You should record the date when your prefilled pen is first removed from the refrigerator, and the date after which it should be discarded.
Zapisati si morate datum, ko je bil napolnjeni injekcijski peresnik vzet iz hladilnika, in datum, po katerem ga je treba zavreči.
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.
Zdravilo Hefiya je indicirano za zdravljenje zmerno do hudo aktivne Crohnove bolezni pri odraslih bolnikih, ki se ne odzovejo na popoln in ustrezen ciklus zdravljenja s kortikosteroidom in/ali imunosupresivom, ali pa takšnega zdravljenja ne prenesejo oz. imajo zanj medicinske kontraindikacije.
• enthesitis-related arthritis,
• artritisa, povezanega z entezitisom,
• night sweats;
• nočno potenje;
Patients should be instructed to seek medical advice if signs / symptoms suggestive of a tuberculosis infection (e.g., persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with Hefiya.
Bolnikom je treba naročiti, naj poiščejo zdravniško pomoč, če med zdravljenjem z zdravilom Hefiya ali po njem doživijo znake ali simptome, ki nakazujejo tuberkulozno okužbo (npr. trdovraten kašelj, hujšanje/izgubljanje teže, nekoliko zvišano telesno temperaturo).
Pulmonary embolism1), interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion1)
pogosti astma, dispneja, kašelj občasni pljučni embolizem1) intersticijska pljučna bolezen, kronična obstruktivna pljučna bolezen,
• Sharps disposal container
• vsebnik za ostre predmete
Adalimumab has not been studied in these patient populations.
Adalimumab pri teh populacijah bolnikov še ni bila preskušen, zato priporočil za odmerjanje ni mogoče dati.
Following the administration of 24 mg / m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 μg / ml for adalimumab without concomitant methotrexate and 11.8 ± 4.3 μg / ml with concomitant methotrexate.
Po dajanju 24 mg/m2 (do največ 40 mg) subkutano vsak drugi teden bolnikom z artritisom, povezanim z entezitisom, ki so bili stari od 6 do 17 let, je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja (vrednost merjena v 24. tednu) 8,8 ± 6,6 μg/ml med uporabo adalimumaba brez metotreksata in 11,8 ± 4,3 μg/ml med sočasno uporabo metotreksata.
Hefiya contains sodium
Zdravilo Hefiya vsebuje natrij
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.
Po subkutani uporabi 40 mg adalimumaba vsak drugi teden pri odraslih bolnikih z revmatoidnim artritisom (RA) so bile povprečne najmanjše koncentracije v stanju dinamičnega ravnovesja približno 5 μg/ml (brez sočasne uporabe metotreksata) in od 8 do 9 μg/ml (s sočasno uporabo metotreksata).
Hefiya is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age.
Zdravilo Hefiya se uporablja za zdravljenje hidradenitis suppurativa pri odraslih in mladostnikih,
Adults with hidradenitis suppurativa
Odrasli s hidradenitis suppurativa
It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.
Pomembno je, da poveste svojemu zdravniku, če dobite znake okužbe, kot so zvišana telesna temperatura, rane, utrujenost ali problemi z zobmi.
• Merkel cell carcinoma (a type of skin cancer);
• karcinom Merklovih celic (tip kožnega raka); • odpoved jeter;
• cough;
• kašelj;
• Do not inject into areas where the skin is tender, bruised, red, scaly, or hard.
• Ne injicirajte v bolečo, podpluto, pordelo, luskasto ali zatrdelo kožo.
solution for injection Multipack: 6 (3 packs of 2) pre-filled pens (SensoReady)
raztopina za injiciranje Večkratno pakiranje: 6 (3 pakiranja po 2) napolnjenih injekcijskih peresnikov (SensoReady)
Figure F: remove the cap
Slika F: Odstranite pokrovček
Of these skin cancers, squamous cell carcinomas occurred at rates (95 % confidence interval) of 2.7 (1.4, 5.4) per 1,000 patient years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient years among control patients.
Med temi kožnimi raki je bil delež (95 % interval zaupanja) skvamocelularnega karcinoma 2,7 (1,4; 5,4) 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.
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.
CRP) in z magnetno resonanco (MRI) sakroiliakalnih sklepov in hrbtenice, se je ohranilo pri bolnikih, zdravljenih z adalimumabom, do 156. tedna oz. do 104. tedna, v tem zaporedju.
Patients received adalimumab 0.8 mg / kg eow (up to 40 mg), 0.4 mg / kg eow (up to 20 mg), or methotrexate 0.1-0.4 mg / kg weekly (up to 25 mg).
0,4 mg/kg vsak drugi teden (do največ 20 mg) ali 0,1-0,4 mg/kg metotreksata na teden (do največ 25 mg).
Anti-adalimumab antibodies may develop during adalimumab treatment.
Med zdravljenjem z adalimumabom se lahko pojavijo protitelesa proti adalimumamu.
Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Podatki, ki so na voljo, kažejo, da je klinični odziv ponavadi dosežen v 12 tednih zdravljenja.
Package leaflet: Information for the patient Hefiya 40 mg solution for injection in pre-filled syringe adalimumab This medicine is subject to additional monitoring.
Navodilo za uporabo Hefiya 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku adalimumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
Statistically significant increases (improvement) from Baseline to week 26 and 52 in Body Mass Index and height velocity were observed for both treatment groups.
V obeh skupinah so opazili statistično pomembno povečanje (izboljšanje) indeksa telesne mase in hitrosti rasti od začetka študije do 26. in 52. tedna.
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).
"minimalno", ne glede na to, ali je med prenehanjem uporabe prišlo do relapsa (69,1 % [123/178] bolnikov, pri katerih je med prenehanjem uporabe prišlo do relapsa, in 88,8 % [95/107] tistih, pri katerih ni prišlo do relapsa).
Patients receiving MTX who achieved a ≥PASI 50 response at week 8 and / or 12 did not receive further dose increases.
Bolnikom, ki so dobivali metotreksat in so 8. in/ali 12. teden dosegli odziv PASI ≥50,
All subjects received open-label induction therapy at a dose based on their Baseline body weight: 160 mg at week 0 and 80 mg at week 2 for subjects ≥ 40 kg, and 80 mg and 40 mg, respectively, for subjects < 40 kg.
Vsi bolniki so prejeli odprto uvodno zdravljenje v odmerku glede na njihovo začetno telesno maso: 160 mg v 0. tednu in 80 mg v 2. tednu bolniki z ≥ 40 kg ter 80 mg in 40 mg v tem vrstnem redu bolniki z < 40 kg.
Children, adolescents and adults with enthesitis-related arthritis Children, adolescents and adults from 6 years of age weighing 30 kg or more The recommended dose of Hefiya is 40 mg every other week.
Otroci, mladostniki in odrasli z artritisom, povezanim z entezitisom Otroci, mladostniki in odrasli, starejši od 6 let, ki tehtajo 30 kg ali več Priporočeni odmerek zdravila Hefiya je 40 mg vsak drugi teden.
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.
Če se nanje ne boste odzvali dovolj dobro, boste za zmanjšanje znakov in simptomov Crohnove bolezni dobili zdravilo Hefiya.
Dosing regimen
Režim odmerjanja
Hefiya is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Ankilozirajoči spondilitis (AS) Zdravilo Hefiya je indicirano za zdravljenje hudega aktivnega ankilozirajočega spondilitisa pri odraslih, ki se na konvencionalno terapijo ne odzovejo ustrezno.
The distribution of patients by age and minimum, median and maximum dose received during the OL LI phase is presented in table 11.
Preglednica 11 prikazuje porazdelitev bolnikov po starosti ter najmanjšem, srednjem in največjem odmerku, prejetem med odprto uvajalno fazo.
• Keep the plunger pressed fully down while you hold the syringe in place for 5 seconds.
• 5 sekund pritiskajte na bat v najnižjem položaju in držite injekcijsko brizgo na mestu.
Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period.
Po 12 tednih je treba nadaljevanje zdravljenja pri bolniku, pri katerem v tem obdobju ni prišlo do izboljšanja, vnovič skrbno pretehtati.
Do not shake.
Ne zamrzujte.
Figure E: choose your injection site
Slika E: Izberite mesto injiciranja
week 26 week 52 p value for standard dose versus low dose comparison.
1 p vrednost za primerjavo standardnega odmerka proti majhnemu odmerku.
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.
Uveitis pri pediatričnih bolnikih Zdravilo Hefiya je indicirano za zdravljenje kroničnega, neinfekcijskega, anteriornega uveitisa pri bolnikih, ki so starejši od 2 let in se niso ustrezno odzvali na konvencionalno zdravljenje, ga ne prenašajo ali pri katerih konvencionalno zdravljenje ni primerno.
Disposing of used pens” at the end of these Instructions for Use.
Odstranjevanje uporabljenih injekcijskih brizg” na koncu teh navodil za uporabo.
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti mišičnoskeletne bolečine
- If you get any side effects, talk to your doctor or pharmacist.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
adalimumab n = 274
adalimu mab n = 274
EU/1/18/1287/001 1 pre-filled syringe EU/1/18/1287/002 2 pre-filled syringes
EU/1/18/1287/001 1 napolnjena injekcijska brizga EU/1/18/1287/002 2 napolnjeni injekcijski brizgi
Leukaemia1)
redki levkemija1)
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.
V študiji pri Crohnovi bolezni I so 299 bolnikov, ki pred tem še niso dobivali antagonistov TNF, randomizirali v eno od štirih skupin: placebo 0. in 2. teden, 160 mg adalimumab 0. teden in 80 mg 2. teden, 80 mg 0. teden in 40 mg 2. teden oziroma 40 mg 0. teden in 20 mg 2. teden.
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).
Varnost in učinkovitost adalimumaba so ocenili v dveh študijah (pJIA I in II) pri otrocih z aktivnim poliartikularnim ali poliartikularnim juvenilnim idiopatskim artritisom, z različnimi tipi začetka JIA
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.
Po subkutanem dajanju 40 mg adalimumaba vsak drugi teden odraslim bolnikom z ne-radiografskim aksialnim spondiloartritisom je bila povprečna (±SD) najmanjša koncentracija v stanju dinamičnega ravnovesja (merjena v 68. tednu) 8,0 ± 4,6 g/ml.
• Store your pen within the carton in a refrigerator, between 2°C to 8°C.
• Injekcijski peresnik shranjujte v škatli v hladilniku pri temperaturi med 2 °C in 8 °C.
506 (62.2)b a percent of patients achieving PASI75 response was calculated as centreadjusted rate b p<0.001, adalimumab vs. placebo
506 (62,2)b a odstotek bolnikov, ki so dosegli odziv PASI 75, je bil izračunan kot delež, korigiran za center.
The recommended Hefiya dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (table 3).
Priporočeni odmerek zdravila Hefiya pri bolnikih s psoriazo v plakih, starih od 4 do 17 let, temelji na telesni masi (preglednica 3).
It is recommended that the conduct and results of these tests are recorded in the Patient Reminder Card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Zdravniki se morajo zavedati tveganja za lažno negativne izvide tuberkulinskega kožnega testa, zlasti pri hudo bolnih ali imunsko oslabelih bolnikih.
This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Pri bolnikih, zdravljenih z adalimumabom, je bil v redkih primerih med obdobjem trženja identificiran hepatosplenični limfom celic T. Ta redka oblika limfoma celic T ima zelo agresiven potek bolezni in je običajno smrtna.
Seventy-nine (20.1 %) patients were treated concomitantly with disease modifying anti-rheumatic drugs, and 37 (9.4 %) patients with glucocorticoids.
bolnikov je sočasno dobivalo imunomodulacijska antirevmatična zdravila, 37 (9,4 %) bolnikov pa glukokortikoide.
• Dispose of the used syringe in a sharps container (closable, puncture-resistant container).
• Uporabljene injekcijske peresnike zavrzite v vsebnik za ostre predmete (vsebnik, ki ga lahko zaprete in ščiti pred vbodi).
adalimumab 40 mg every other week N = 70
adalimumab 40 mg vsak drugi teden N = 70
Respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral)
zelo pogosti okužbe respiratornega trakta (vključno z okužbo spodnjega in zgornjega respiratornega trakta, pljučnico, vnetjem sinusa, vnetjem sluznice žrela,
Malignancies and lymphoproliferative disorders
Malignomi in limfoproliferativne bolezni
Children and adolescents from 6 to 17 years of age weighing less than 40 kg
Otroci in mladostniki, stari od 6 do 17 let, ki tehtajo manj kot 40 kg
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.
Mediani čas do neuspeha zdravljenja je bil 24,1 tedna za bolnike, ki so se zdravili s placebom, medtem ko mediani čas do neuspeha zdravljenja pri bolnikih, ki so bili zdravljeni z adalimumabom, ni bilo mogoče oceniti, ker je bilo zdravljenje neuspešno pri manj kot polovici teh bolnikov.
• mouth infections (including tooth infections and cold sores);
• okužbe ustne votline (vključno z okužbami zob in herpesom);
• eye infections;
• okužbe ušesa;
Hefiya is used to treat psoriatic arthritis in adults.
Zdravilo Hefiya se uporablja za zdravljenje psoriatičnega artritisa pri odraslih.
Hefiya dose for paediatric patients with plaque psoriasis Patient weight
Odmerjanje zdravila Hefiya pri pediatričnih bolnikih s psoriazo v plakih
In these trials, 11.9 % of patients treated with adalimumab and 8.1 % of placebo and active control-treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24.
V teh preskušanjih so pozitivne titre protijedrnih protiteles po 24 tednih ugotovili pri 11,9 % prejemnikov adalimumaba in 8,1 % prejemnikov placeba in kontrolne učinkovine, ki so imeli izhodiščno negativne titre teh protiteles.
• blood in urine;
• kri v urinu; • težave z ledvicami;
STATEMENT OF ACTIVE SUBSTANCE
SEZNAM POMOŽNIH SNOVI
Figure E: clean your injection site
Slika E: Očistite mesto injiciranja
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.
Pri odraslih bolnikih z uveitisom je polnilni odmerek 80 mg adalimumaba v 0. tednu, ki mu je sledil odmerek 40 mg adalimumaba vsak drugi teden z začetkom v 1. tednu, povzročil povprečno koncentracijo v stanju dinamičnega ravnovesja približno 8 do 10 µg/ml.
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).
Response; najmanj 50 % zmanjšanje skupnega števila abscesov in inflamatornih nodulov brez povečanja števila abscesov in fistul z izcedkom glede na izhodiščno število).
week 8 and 52 sustained response sustained remission sustained mucosal healing clinical remission is Mayo score ≤ 2 with no subscore > 1; clinical response is decrease from baseline in Mayo score ≥ 3 points and ≥ 30 % plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS of 0 or 1; * p < 0.05 for adalimumab vs. placebo pairwise comparison of proportions ** p < 0.001 for adalimumab vs. placebo pairwise comparison of proportions a of those receiving corticosteroids at baseline
klinična remisija pomeni oceno Mayo ≤ 2 in nobene podocene > 1; klinični odgovor pomeni znižanje ocene Mayo od začetka za ≥ 3 in ≥ 30 % ter znižanje podocene rektalne krvavitve [RBS] ≥ 1 ali absolutna RBS 0 ali 1;
If you have questions, please ask your doctor.
Če imate kakršna koli vprašanja, se pogovorite z zdravstvenim delavcem.
Available data suggest that clinical response is usually achieved within 12 weeks of treatment.
Razpoložljivi podatki kažejo, da se klinični odziv običajno pojavi v 12 tednih zdravljenja.
The first received placebo injections every week for 52 weeks.
placebo so dobivali vsak teden enako dolgo.
Figure I: complete your injection
Slika I: Končajte injiciranje
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, are inflammatory diseases of the spine.
Ankilozirajoči spondilitis in aksialni spondiloartritis brez radiografskega dokaza za ankilozirajoči spondilitis sta vnetni bolezni hrbtenice.
Completing your injection:
Zaključek injiciranja:
Multipack cartons contain 6 (3 packs of 2) pre-filled syringes of Hefiya.
Škatle za večkratno pakiranje vsebujejo 6 (3 pakiranja po 2) napolnjenih injekcijskih brizg zdravila Hefiya.
Do not remove the finger flange before the injection.
Ne odstranjujte držala pred injiciranjem.
disease flares at the end of 32 weeksa (n/N)
32-tedenskega obdobjaa (n/N)
Opportunistic infections, including invasive fungal infections have been observed in patients receiving adalimumab.
Druge oportunistične okužbe Pri bolnikih, ki so dobivali adalimumab, so opažali oportunistične okužbe, vključno z invazivnimi glivičnimi okužbami.
No malignancies were observed in 77 paediatric patients with an exposure of 80.0 patient years during an adalimumab trial in paediatric patients with chronic plaque psoriasis.
Pri 77 pediatričnih bolnikih v preskušanju adalimumaba pri pediatričnih bolnikih s kronično psoriazo v plakih z izpostavljenostjo 80,0 bolnikov-let niso opazili malignomov.
Dose interruption
Prekinitev uporabe
Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.
V študiji 226 odraslih preiskovancev z revmatoidnim artritisom, ki so dobivali adalimumab ali placebo, so ugotovili podobne odzive protiteles na standardno 23-valentno pnevmokokno cepivo in trivalentno virusno cepivo proti influenci.
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.
Zdravilo Hefiya je indicirano za zdravljenje zmerno do hudo aktivne Crohnove bolezni pri pediatričnih bolnikih (od 6. leta starosti), ki se ne odzovejo zadovoljivo na konvencionalno zdravljenje, vključno s primarno prehransko terapijo in kortikosteroidom in/ali imunomodulatorjem,
SC
Pc
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.
Ob zdravljenju z adalimumabom so v primerjavi s placebom 24. teden ugotovili statistično značilno izboljšanje telesnega delovanja, ocenjeno s HAQ in vprašalnikom SF 36 (Short Form Health Survey).
Adalimumab / methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see table 9).
Pri bolnikih, ki so dobivali adalimumab in metotreksat, je bilo po 6 in 12 mesecih (glejte preglednico 9) statistično značilno manj rentgenografskih znakov napredovanja kot pri bolnikih, ki so dobivali samo metotreksat.
Following the administration of 24 mg / m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) who were 4 to 17 years the mean trough steady-state (values measured from week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 µg / ml (102 % CV) for adalimumab without concomitant methotrexate and 10.9 ± 5.2 µg / ml (47.7 % CV) with concomitant methotrexate.
Po uporabi 24 mg/m2 (do največ 40 mg) subkutano vsak drugi teden pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, starih od 4 do 17 let, je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja (vrednosti merjene od 20. do 48. tedna) med uporabo adalimumaba brez metotreksata 5,6 ± 5,6 µg/ml (koeficient variacije 102 %) in med uporabo z metotreksatom 10,9 ± 5,2 µg/ml (koeficient variacije 47,7 %).
The long half-life of adalimumab should be taken into consideration if a surgical procedure is planned.
Če je predviden kirurški poseg, je treba upoštevati dolg razpolovni čas adalimumaba.
• Keep holding your pen firmly against your skin.
• Injekcijski peresnik trdno pritiskajte ob kožo.
Each syringe contains 40 mg/0.8 ml of Hefiya.
Ena injekcijska brizga vsebuje 40 mg/0,8 ml zdravila Hefiya.
In adult patients with psoriasis, the mean steady-state trough concentration was 5 µg / ml during adalimumab 40 mg every other week monotherapy treatment.
Pri odraslih bolnikih s psoriazo je bila povprečna najmanjša koncentracija v stanju dinamičnega ravnovesja med monoterapijo s 40 mg adalimumaba vsak drugi teden 5 µg/ml.
Hefiya is administered by subcutaneous injection.
Zdravilo Hefiya se uporablja kot subkutana injekcija.
• angioedema (localised swelling of the skin);
• sindrom podoben lupusu; • angioedem (lokalizirano otekanje kože);