natgillin/translations-raw huggingface dataset:
Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see Section 5.1) and to improve physical function. 
Z rentgenskim slikanjem je bilo dokazano, da adalimumab upočasni hitrost napredovanja prizadetosti perifernih sklepov pri bolnikih s poliartikularno, simetrično podvrsto bolezni (glejte poglavje 5.1) in izboljša telesno funkcijo.
• Wash your hands thoroughly 
• Dobro si umijte roke.
2616LR Delft The Netherlands 
2616LR Delft
Keep this Patient Reminder Card with you during your treatment and for 4 months after your (or your child's) last injection of Imraldi. 
To Opozorilno kartico za bolnika imejte pri sebi ves čas zdravljenja z zdravilom Imraldi in še 4 mesece po tem, ko ste vi (ali vaš otrok) prejeli zadnjo injekcijo zdravila Imraldi.
• Tell your doctor if your child has a history of recurrent infections or other conditions that increase the risk of infections. 
• Zdravniku morate povedati, če je vaš otrok v preteklosti imel ponavljajoče se okužbe ali druge bolezni, ki zvečujejo tveganje za okužbe.
Keep this Patient Reminder Card with you or your child during his/her treatment and for 4 months after your child's last injection of Imraldi. 
To Opozorilno kartico za bolnika imejte vi ali vaš otrok pri sebi ves čas njegovega zdravljenja z zdravilom Imraldi in še 4 mesece po tem, ko je vaš otrok prejel zadnjo injekcijo zdravila Imraldi.
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). 
Po 12. tednih terapije so bolnike, ki so prejemali adalimumab v obdobju A, ponovno randomizirali v obdobju B v eno izmed treh skupin zdravljenja (40 mg adalimumaba vsak teden, 40 mg adalimumaba vsak drugi teden ali placebo od 12. do 35. tedna).
• angioedema (localized swelling of the skin); 
• angioedem (lokalizirano otekanje kože);
o 1) One 1 ml syringe o 2) One vial adapter o 3) One vial for paediatric use of Imraldi for injection o 4) Two alcohol swabs o 5) One needle 
o 1) eno 1 ml brizgo o 2) en adapter za vialo o 3) eno vialo zdravila Imraldi za injiciranje za otroke o 4) dva alkoholna zloženca o 5) eno iglo
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). 
Bolniki, ki so za indukcijo dobili 160/80 mg adalimumaba, so 8. teden v primerjavi s placebom dosegli klinično remisijo v statistično značilno večjem odstotku tako v študiji UC-I (18 % v primerjavi z 9 %, p = 0,031) kot v študiji UC-II (17 % v primerjavi z 9 %, p = 0,019).
• If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Imraldi and contact your doctor immediately since, in rare cases, these reactions can be life-threatening. 
• Če imate alergijske reakcije s simptomi, kot so tiščanje v prsih, piskajoče dihanje, omotica, otekanje ali izpuščaj, zdravila Imraldi ne injicirajte več in se takoj posvetujte z zdravnikom, saj so v redkih primerih te reakcije lahko življenje ogrožajoče.
During treatment with Imraldi, other concomitant therapies (e.g., corticosteroids and/or immunomodulatory agents) should be optimised. 
Med zdravljenjem z zdravilom Imraldi je treba optimizirati druge sočasne terapije (npr. kortikosteroide in/ali imunomodulacijska zdravila).
6) Throwing away supplies 
6) Kako zavreči ostanke
You should record the date when the syringe is first removed from refrigerator, and the date after which it should be discarded. 
Zapisati si morate datum, ko je bila brizga vzeta iz hladilnika, in datum, po katerem jo je potrebno zavreči.
Once removed from the refrigerator for room temperature storage, the syringe must be used within 28 days or discarded, even if it is returned to the refrigerator. 
Ko ga enkrat, namesto v hladilniku, shranjujete pri sobni temperaturi, morate peresnik porabiti v 28 dneh ali pa zavreči, tudi če ga vrnete v hladilnik.
It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Imraldi. 
Za otroke je priporočljivo, da pred začetkom zdravljenja z zdravilom Imraldi opravijo vsa predvidena cepljenja za njihovo starost, če je le mogoče.
Adolescent hidradenitis suppurativa (from 12 years of age, weighing at least 30 kg) There are no clinical trials with adalimumab in adolescent patients with HS. 
Hidradenitis suppurativa pri mladostnikih (starejših od 12 let, ki tehtajo najmanj 30 kg) Kliničnih študij z adalimumabom pri mladostnikih s HS ni.
DO NOT use any item after the date shown on the box. 
Zdravila NE UPORABLJAJTE po izteku roka uporabnosti, navedenega na škatli.
Carefully pull off the needle cap. 
Previdno snemite pokrovček za iglo.
The combination of Imraldi and abatacept is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”). 
Kombinacija zdravila Imraldi in abatacepta ni priporočljiva (glejte poglavje 4.4 “Sočasna uporaba bioloških DMARDS ali antagonistov TNF”).
Adalimumab treated patients had significantly greater improvement at week 12 which was maintained through week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL). 
Bolniki, ki so dobivali adalimumab, so imeli po 12 tednih značilno večje izboljšanje (ki se je ohranilo do 24. tedna) SF36 in ASQoL (Vprašalnik o kakovosti življenja pri ankilozirajočem spondilitisuAnkylosing Spondylitis Quality of Life Questionnaire).
• Do not use the 40 mg pre-filled syringe if doses other than 40 mg are recommended. 
• Ne uporabite 40 mg napolnjenega injekcijskega peresnika, če je priporočen drugačen odmerek kot 40 mg.
PASI 75 and PGA clear or minimal increased with increasing adalimumab concentrations, both with a similar apparent EC50 of approximately 4.5 μg/mL (95% CI 0.4-47.6 and 1.9-10.5, respectively). 
PASI 75 in PGA čisto ali minimalno, sta se povečevali z zvečanjem koncentracije adalimumaba, obe s podobno navidezno EC50, za približno 4,5 μg/ml (95% IZ 0,4-47,6 in 1,9-10,5).
ASDASc Inactive Disease 
ASASa delno izboljšanje ASDASc neaktivna bolezen
Week 56 
56. teden
On rare occasions, a specific and severe type of lymphoma has been observed in patients taking Imraldi. 
V redkih primerih so pri bolnikih, ki dobivajo zdravilo Imraldi, opazili specifično in resno obliko limfoma.
Table 21 Efficacy Results at 12 Weeks, HS Studies I and II 
Rezultati učinkovitosti v 12. tednu, HS študiji I in II Študija HS I
• Before you inject, ask your doctor or nurse to show you how to use your pre-filled syringe. 
• Pred injiciranjem prosite zdravnika ali medicinsko sestro, da vam pokažeta, kako uporabljati napolnjeno injekcijsko brizgo.
Pull the syringe away from your skin. 
Povlecite injekcijsko brizgo stran od kože.
• Merkel cell carcinoma (a type of skin cancer); 
• karcinom Merklovih celic (tip kožnega raka);
What Imraldi is and what it is used for 
Kaj je zdravilo Imraldi in za kaj ga uporabljamo
• Tell your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections. 
• Zdravniku morate povedati, če ste imeli v preteklosti ponavljajoče se okužbe ali druge bolezni, ki zvečujejo tveganje za okužbe.
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. 
Uporabo 40 mg adalimumaba vsak drugi teden so pri bolnikih z zmernim do hudim aktivnim psoriatičnim artritisom proučili v dveh s placebom kontroliranih študijah, študijah pri psoriatičnem artritisu I in II.
Continue to hold 
Še naprej držite peresnik
Imraldi is indicated for the treatment of Crohn's disease in children aged 6 to 17 years. 
Zdravilo Imraldi je indicirano za zdravljenje Crohnove bolezni pri otrocih, starih 6 do 17 let.
104 Week 28.4% 28.1% 46.6% <0.001 <0.001 0.864 a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test. 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 
104. teden 28,4 % 28,1 % 46,6 % < 0,001 < 0,001 0,864 a 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 c Vrednost p se nanaša na parno primerjavo monoterapije z adalimumabom in monoterapije z metotreksatom z Mann-Whitneyevim testom U
When needed (for example when you are travelling), a single Imraldi pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 28 days - be sure to protect it from light. 
Če je potrebno (na primer kadar potujete), lahko posamezno napolnjeno injekcijsko brizgo zdravila Imraldi hranite pri sobni temperaturi (do 25 ºC) za največ do 28 dni - zagotovite, da bo zaščitena pred svetlobo.
In a study of 64 patients with rheumatoid arthritis that were treated with adalimumab, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-, B, - NK-cells, monocyte/macrophages, and neutrophils. 
V študiji 64 bolnikov z revmatoidnim artritisom, zdravljenih z adalimumabom, niso odkrili znakov zavrtja odložene preobčutljivosti, znižanja koncentracije imunoglobulinov ali spremembe števila efektorskih celic T in B, naravnih celic ubijalk, monocitov/makrofagov ali nevtrofilcev.
If you forget to use Imraldi 
Če ste pozabili uporabiti zdravilo Imraldi
Your doctor or nurse should make sure you can use your syringe correctly. 
Zdravnik ali medicinska sestra naj se prepričata, da znate injekcijsko brizgo pravilno uporabljati.
DO NOT over-tighten. 
Brizge NE STRESAJTE.
• As cases of tuberculosis have been reported in patients treated with Imraldi, your doctor will check you for signs and symptoms of tuberculosis before starting Imraldi. 
• Ker so bili pri bolnikih, zdravljenih z zdravilom Imraldi, opisani primeri tuberkuloze, vas bo zdravnik pred začetkom zdravljenja z zdravilom Imraldi preiskal glede znakov in simptomov tuberkuloze.
The adjusted OR (accounting for baseline differences) was 1.10 (95 % CI 0.45-2.73) with RA and CD combined. 
Prilagojeno razmerje obetov (z ozirom na izhodiščne razlike) je bilo 1.10 (95 % interval zaupanja 0.45-2.73) z RA in CB skupaj.
In RA study IV, the ACR 20 response of patients treated with adalimumab plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p <0.001). 
V študiji revmatoidnega artritisa IV je bil odziv 20 po ACR pri bolnikih, zdravljenih z adalimumabom in standardno oskrbo, statistično značilno boljši kot pri bolnikih, zdravljenih s placebom in standardno oskrbo (p < 0,001).
This study evaluated the efficacy of adalimumab 40 mg every other week/methotrexate combination therapy, adalimumab 40 mg every other week monotherapy and methotrexate monotherapy in reducing the signs and symptoms and rate of progression of joint damage in rheumatoid arthritis for 104 weeks. 
Ta študija je ocenila učinkovitost treh shem (kombinirano zdravljenje s 40 mg adalimumaba vsak drugi teden/metotreksatom, monoterapija s 40 mg adalimumaba vsak drugi teden in monoterapija z metotreksatom) za zmanjšanje znakov in simptomov ter hitrosti napredovanja sklepne okvare pri revmatoidnem artritisu v obdobju 104 tednov.
• Prepare the syringe by partially peeling the package open from the end closest to white plunger rod. 
• Pripravite brizgo: delno odprite njeno ovojnino tako, da jo odlepite od konca, ki je najbližji belemu nosilcu bata.
Imraldi may be available as a vial, a pre-filled syringe and/or a pre-filled pen. 
Zdravilo Imraldi je lahko na voljo kot viala, napolnjena injekcijska brizga in/ali napolnjen injekcijski peresnik.
TNF-antagonists including adalimumab have been associated in rare instances with new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease including multiple sclerosis and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome. 
Antagonisti tumorje nekrotizirajočega faktorja (TNF), z adalimumabom vred, so bili v redkih primerih povezani s pojavom ali poslabšanjem kliničnih simptomov in/ali rentgenoloških znakov demielinizirajoče bolezni osrednjega živčnega sistema, vključno z multiplo sklerozo in optičnim nevritisom, in periferne demielinizirajoče bolezni, vključno z Guillain-Barréjevim sindromom.
Amongst those who responded at week 16 (n=144), the Paediatric ACR 30/50/70/90 responses were maintained for up to six years in the OLE phase in patients who received adalimumab throughout the study. 
Med bolniki, ki so se odzvali 16. teden (n = 144), so se odzivi»Paediatric ACR« 30/50/70/90 v odprti podaljšani fazi ohranili do 6 let pri tistih, ki so ves čas študije dobivali adalimumab.
Should treatment be interrupted, Imraldi 40 mg every week or 80 mg every other week may be reintroduced (see section 5.1). 
Če je potrebno z zdravljenjem prekiniti, lahko ponovno uvedete zdravljenje z zdravilom Imraldi z odmerkom 40 mg vsak teden ali 80 mg vsak drugi teden (glejte poglavje 5.1).
Read all of this leaflet carefully before your child starts using this medicine because it contains important information. 
Preden vaš otrok začne uporabljati to zdravilo, natančno preberite navodilo, ker vsebuje pomembne podatke!
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, odmerka niso več povečevali.
Imraldi is used to treat 
Zdravilo Imraldi se uporablja za zdravljenje
Imraldi 40 mg solution for injection in single-use vial (type I glass), fitted with rubber stoppers, aluminium crimps and flip-off seals. 
Imraldi 40 mg raztopina za injiciranje v viali za enkratno uporabo (steklo tipa I), opremljeni z zamaški iz gume, folijami iz aluminija in tesnili "flip-off".
Imraldi is a biosimilar medicinal product. 
Zdravilo Imraldi je podobno biološko zdravilo.
Alternatively, if a patient has stopped Imraldi and signs and symptoms of disease recur, Imraldi may be re-administered. 
Če bolnik neha uporabljati zdravilo Imraldi, pa se znaki in simptomi bolezni ponovijo, je mogoče zdravilo Imraldi znova uvesti.
Hold the white plunger rod in and turn the vial and syringe upside down. 
Držite beli nosilec bata in obrnite vialo in brizgo tako, da je viala zgoraj.
• Use one of the alcohol pads to wipe the vial stopper. 
• Uporabite enega od alkoholnih zložencev in z njim obrišite zamašek viale.
Of 342 subjects originally randomized to adalimumab monotherapy or adalimumab/methotrexate combination therapy who entered the open-label extension study, 171 subjects completed 10 years of adalimumab treatment. 
Od 342 oseb, ki so bile od začetka randomizirane na monoterapijo z adalimumabom ali kombinirano zdravljenje z adalimumabom/metotreksatom in so bile vključene v odprto podaljšanje študije, je 171 bolnikov zaključilo 10-letno zdravljenje z adalimumabom.
A modified Total Sharp Score (mTSS), which included distal interphalangeal joints (i.e. not identical to the TSS used for rheumatoid arthritis), was used. 
Za oceno so uporabili modificirani celotni seštevek po Sharpu (modified Total Sharp Score, mTSS), ki je vključil distalne interfalangealne sklepe (tj. ni bil enak TSS, ki se uporablja za revmatoidni artritis).
If you have COPD, or you are a heavy smoker, you should discuss with your doctor whether treatment with a TNFα blocker is appropriate for you. 
Če imate KOPB ali če veliko kadite, se morate z zdravnikom posvetovati, ali je zdravljenje z zaviralcem TNFα za vas primerno.
In the Phase 3 trial of adalimumab in patients with paediatric Crohn's disease which evaluated efficacy and safety of two body weight adjusted maintenance dose regimens following body weight adjusted induction therapy up to 52 weeks of treatment, ALT elevations ≥3 × ULN occurred in 2.6 % (5/192) of patients of whom 4 were receiving concomitant immunosuppressants at baseline. 
V preskušanju faze 3 z adalimumabom pri bolnikih s pediatrično Crohnovo boleznijo, kjer so ocenjevali učinkovitost in varnost dveh telesni masi prilagojenih vzdrževalnih režimov odmerjanja, ki sta sledila telesni masi prilagojenemu začetnemu zdravljenju do 52 tednov zdravljenja, so se pojavila zvišanja ALT ≥ 3 × ULN pri 2,6 % (5/192) bolnikov, od katerih so štirje sočasno prejemali imunosupresive ob začetku preskušanja.
• As cases of tuberculosis have been reported in patients treated with Imraldi, your doctor will check your child for signs and symptoms of tuberculosis before starting Imraldi. 
• Ker so bili pri bolnikih, zdravljenih z zdravilom Imraldi, opisani primeri tuberkuloze, bo zdravnik pred začetkom zdravljenja z zdravilom Imraldi vašega otroka preiskal glede znakov in simptomov tuberkuloze.
What you need to know before you use Imraldi 3. 
Kaj morate vedeti, preden boste uporabili zdravilo Imraldi 3.
• sensation disorders such as tingling, prickling or numbness; 
• motnje v občutenju, kot so ščemenje, zbadanje ali omrtvelost;
Subjects (n=215, 54.7%) who failed to achieve ASAS 20 at weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses. 
Preiskovanci (n = 215, 54,7 %), ki 12. ali 16. ali 20. teden niso dosegli ASAS 20, so začeli v predčasni odprti fazi dobivati 40 mg adalimumaba vsak drugi teden subkutano, v poznejših statističnih analizah dvojno slepe faze pa so bili obravnavani kot neodzivni bolniki.
The decision to stop using Imraldi should be discussed with your child's doctor. 
O odločitvi, da bi prenehali uporabljati zdravilo Imraldi, se morate posvetovati z zdravnikom svojega otroka.
A greater proportion of patients on adalimumab had no disease flare during the double-blind period, when compared with those on placebo (70.4% vs. 47.1%, p<0.001) (Figure 1). 
Pri večjem deležu bolnikov, ki so prejemali zdravilo adalimumab, v dvojno slepem obdobju ni prišlo do ponovnega zagona bolezni v primerjavi s tistimi, ki so prejemali placebo (70,4 % v primerjavi s 47,1 %, p < 0,001) (slika 1).
Patients were then re-treated with adalimumab 0.8 mg/kg eow for an additional 16 weeks and response rates observed during retreatment were similar to the previous double-blind period: PASI 75 response of 78.9 % (15 of 19 subjects) and PGA clear or minimal of 52.6 % (10 of 19 subjects). 
Bolniki so bili nato znova zdravljeni z adalimumabom v odmerku 0,8 mg/kg vsak drugi teden še nadaljnjih 16 tednov, pri čemer so bile opažene stopnje odziva podobne kot v prejšnjem dvojno slepem obdobju: odziv PASI 75 pri 78,9 % (15 od 19 oseb) in PGA čisto ali minimalno pri 52,6 % (10 od 19 oseb).
- the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. 
- Zdravljenje hudega, aktivnega in progresivnega revmatoidnega artritisa pri odraslih, ki prej še niso dobivali metotreksata.
Imraldi can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), corticosteroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs). 
Zdravilo Imraldi se lahko uporablja skupaj z metotreksatom ali nekaterimi imunomodulirajočimi antirevmatičnimi zdravili (sulfasalazinom, hidroksiklorokinom, leflunomidom in pripravki zlata za injiciranje), kortikosteroidi in zdravili proti bolečinam, vključno z nesteroidnimi protivnetnimi zdravili.
• Push the white plunger rod gently into the syringe until the syringe contains the prescribed amount of liquid. 
• Beli nosilec bata previdno potiskajte v brizgo, dokler brizga ne vsebuje predpisane količine tekočine.
No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab. 
Podatkov o sekundarnem prenosu okužbe z živimi cepivi pri bolnikih,
Clean your injection site with an alcohol pad. 
Mesto injiciranja očistite z alkoholnim zložencem.
• Before you inject, ask your doctor or nurse to show you how to use your pre-filled pen. 
• Pred injiciranjem prosite zdravnika ali medicinsko sestro, da vam pokažeta, kako uporabljati napolnjen injekcijski peresnik.
• systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems); 
• sistemski eritematozni lupus (vključno z vnetjem kože, srca, pljuč, sklepov in drugih organskih sistemov);
Place your pre-filled syringe and alcohol pads on a clean, dry surface. 
Napolnjeno injekcijsko brizgo in alkoholna zloženca položite na čisto, suho površino.
Note: P# = Placebo (Number of Events/Number at Risk); A# = Adalimumab (Number of Events/Number at Risk). 
Opomba: P# = placebo (število dogodkov/število rizičnih preiskovancev); A# = adalimumab (število dogodkov/število rizičnih preiskovancev).
• oedema (a build up of fluid in the body which causes the affected tissue to swell); 
• edem (kopičenje tekočine v telesu, ki povzroči otekanje prizadetega tkiva);
Lupus-like syndrome 
Sindrom, podoben lupusu
If your child has COPD, or is a heavy smoker, you should discuss with your doctor whether treatment with a TNFα blocker is appropriate for your child. 
Če ima vaš otrok KOPB ali če veliko kadi, se morate z zdravnikom posvetovati, ali je zdravljenje z zaviralcem TNFα za primerno za vašega otroka.
• Tell your doctor if your child is a carrier of the hepatitis B virus (HBV), if he/she has active HBV infection or if you think he/she might be at risk of contracting HBV. 
• Zdravniku morate povedati, če je vaš otrok nosilec virusa hepatitisa B (HBV), če ima aktivno okužbo s HBV ali če mislite, da bi se lahko nalezel HBV.
Very common Injection site reaction (including injection site erythema) Common 
zelo pogosti reakcija na mestu injiciranja (vključno z eritemom na mestu injiciranja)
If you don't know the amount, STOP HERE and contact your doctor for further instruction. 
TUKAJ USTAVITE in kontaktirajte otrokovega zdravnika za nadaljnja navodila.
It is very important that you tell your doctor if your child has ever had tuberculosis, or if he/she has been in close contact with someone who has had tuberculosis. 
Zelo pomembno je, da zdravniku poveste, če je vaš otrok kadarkoli imel tuberkulozo ali bil v tesnem stiku s kom, ki jo je imel.
The mean (±SD) serum adalimumab trough concentrations achieved at week 4 were 15.7±6.6 µg/ml for patients ≥40 kg (160/80 mg) and 10.6±6.1 µg/ml for patients <40 kg (80/40 mg). 
Povprečne (±SD) serumske koncentracije adalimumaba, dosežene v 4. tednu, so bile 15,7 ± 6,6 μg/ml pri bolnikih ≥ 40 kg (160/80 mg) in 10,6 ± 6,1 μg/ml pri bolnikih < 40 kg (80/40 mg).
• When you are sure the adapter is attached to the vial, lift off the package from the vial adapter. 
• Ko ste prepričani, da je adapter nameščen na vialo, z njega snemite njegovo ovojnino.
5) Injecting Imraldi 
5) Injiciranje zdravila Imraldi
• It is important that you tell your baby's doctors and other health care professionals about your Imraldi 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 Imraldi, preden bo vaš dojenček prejel katerokoli cepivo (za več informacij o cepljenju glejte poglavje "Opozorila in previdnostni ukrepi").
Vial storage 
Shranjevanje viale