natgillin/translations-raw huggingface dataset:
* further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies including spontaneous reporting data 
*Nadaljnje informacije v zvezi s tem najdete v poglavjih 4.3, 4.4 in 4.8 **Vključno pri podaljšanih študijah brez placeba Vključno s podatki iz spontanega poročanja
Concomitant stable doses of one non-biologic immunosuppressant were permitted. 
Sočasni stalni odmerki enega nebiološkega imunosupresiva so bili dovoljeni.
• A sharps container (see section 7.2). 
• zbiralnik za ostre predmete (glejte poglavje 7.2).
Kromeya can also be given alone. 
Zdravilo Kromeya se lahko daje tudi samo.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Preobčutljivost na učinkovino ali katero koli pomoţno snov, navedeno v poglavju 6.1.
Week 8 and 52 
8. in 52. teden
Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted and 80% of patients continued to receive at least one of these medications. 
Dovoljeni so bili sočasni stabilni odmerki aminosalicilatov, kortikosteroidov in/ali imunomodulatorjev in 80 % bolnikov je nadaljevalo z dobivanjem vsaj enega od teh zdravil.
If you still see air gaps or bubbles at the tip of the syringe, repeat this step until air gaps or bubbles are gone. 
Če v konici injekcijske brizge še vedno vidite zrak ali zračne mehurčke, ta korak ponovite, dokler jih ne odstranite.
TREATMENT FAILURE RATE (%) 
ODSTOTEK NEUSPEHA ZDRAVLJENJA (%)
Label area (Kromeya, dose, expiration date) 
Nalepka (Kromeya, odmerek, rok uporabnosti)
Doing so could damage the syringe or activate the clear needle guard. 
S tem bi lahko poškodovali injekcijsko brizgo ali aktivirali prozorno varovalo za iglo.
Psoriasis study I (REVEAL) evaluated 1212 patients within three treatment periods. 
Študija pri psoriazi I (REVEAL) je ocenila 1212 bolnikov v treh obdobjih zdravljenja.
Side effects may occur up to 4 months or more after the last Kromeya injection. 
Neţeleni učinki se lahko pojavijo še 4 mesece ali več po zadnji injekciji zdravila Kromeya.
Of those in clinical response at week 4, 48% had been previously exposed to other TNF-antagonists. 
Od teh s kliničnim odzivom v 4. tednu jih je bilo 48 % prej izpostavljenih drugim TNF-antagonistom.
• When the syringe plunger has moved to the bottom and has stopped moving, continue holding it for 5 seconds. 
• Ko se je bat premaknil do konca in se je prenehal premikati, drţite injekcijski peresnik na mestu še 5 sekund.
Appropriate screening tests (i.e. tuberculin skin test and chest X-ray) should be performed in all patients (local recommendations may apply). 
Pri vseh bolnikih je treba narediti ustrezne presejalne preiskave (tj. tuberkulinski koţni test in rentgensko slikanje prsnih organov) (veljajo lahko lokalna priporočila).
Check components to make sure that the packaging and the content are not damaged. 
Pripomočke preglejte in preverite, ali sta ovojnina in vsebina nepoškodovani.
Impaired lung function may increase the risk for developing infections. 
Okvarjena pljučna funkcija lahko zveča tveganje za razvoj okuţbe.
One hundred patients (n=100) from the Paediatric CD study continued in an open-label long-term extension study. 
Sto bolnikov (n = 100) iz študije Crohnove bolezni pri pediatričnih bolnikih je nadaljevalo v odprti dolgoročni podaljšani študiji.
Available data suggest that re-introduction of adalimumab after discontinuation for 70 days or longer resulted in the same magnitudes of clinical response and similar safety profile as before dose interruption. 
Razpoloţljivi podatki kaţejo, da je adalimumab po ponovni uvedbi, ki je sledila prekinitvi za 70 dni ali več, dosegel enako velik klinični odziv in je imel podobne varnostne značilnosti kot pred prekinitvijo.
• If you are over 65 years you may be more susceptible to infections while taking Kromeya. 
• Če ste starejši od 65 let, ste morda dovzetnejši za okuţbe, če jemljete zdravilo Kromeya.
A large number (approximately 2100) of prospectively collected pregnancies exposed to adalimumab resulting in live birth with known outcomes, including more than 1500 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn. 
Veliko število (pribliţno 2100) v naprej izbranih nosečnosti, med katerimi so bile matere izpostavljene adalimumabu in jim je sledilo rojstvo ţivorojenih otrok z znanim izidom, vključno s 1500 izpostavljenimi v prvem trimesečju, ne nakazuje povečanja razmerja malformacij pri novorojenčkih.
Tuberculosis can develop during therapy even if your child has had preventative treatment for tuberculosis. 
Tuberkuloza se lahko razvije med zdravljenjem, tudi če je vaš otrok imel preventivno zdravljenje za tuberkulozo.
Given orally, immunoglobulin G proteins undergo intestinal proteolysis and have poor bioavailability. 
Pri peroralnem dajanju so imunoglobulini G podvrţeni intestinalni proteolizi in imajo nizko biološko razpoloţljivost.
Preclinical data on fertility effects of adalimumab are not available. 
Predkliničnih podatkov o učinkih adalimumaba na plodnost ni na voljo.
• serious infections (including blood poisoning and influenza); 
• resne okuţbe (vključno z zastrupitvijo krvi in gripo);
Significant response was first observed at week 2 and maintained through 24 weeks (Table 
Značilen odziv so najprej opazili po 2 tednih in se je ohranil do 24. tedna (preglednica 13).
Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1. 
Za kombinirano uporabo z drugimi imunomodulirajočimi antirevmatičnimi zdravili razen metotreksata glejte poglavji 4.4 in 5.1.
For patients who test positive for hepatitis B infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended. 
Pri bolnikih, ki so pozitivni na okuţbo s hepatitisom B, se priporoča posvetovanje z zdravnikom specialistom za zdravljenje okuţb s hepatitisom B.
Clinical response (CR-100) was maintained in 102 and 233 patients, respectively. 
Klinični odziv (CR-100) se je ohranil pri 102 oz. 233 bolnikih.
Health-related quality of life and physical function were assessed using the HAQ-S and the SF-36 questionnaires. 
Z zdravjem povezano kakovost ţivljenja in telesno funkcijo so ocenjevali s pomočjo vprašalnikov HAQ-S in SF-36.
Solution for injection (injection). 
Raztopina za injiciranje (injekcija).
Read all of this leaflet carefully before your child starts using this medicine because it contains important information. 
Natančno preberite navodilo, preden vaš otrok začne uporabljati to zdravilo, ker vsebuje pomembne podatke!
The corresponding proportions of patients with no radiographic progression were 31.3%, 23.7% and 36.7% respectively. 
Ustrezni deleţi bolnikov, ki niso imeli rentgenografskih znakov napredovanja, so bili 31,3 %, 23,7 % oz. 36,7 %.
Rare (may affect up to 1 in 1,000 people): • low blood measurements for white blood cells, red blood cells and platelet count. 
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): • nizke vrednosti za bele krvne celice, rdeče krvne celice in trombocite.
Open your sharps disposal container so it is ready to use. 
Zbiralnik za ostre predmete odprite, da je pripravljen za uporabo.
1.3 Remove the box from the refrigerator (Figure B). 
1.3 Škatlo vzemite iz hladilnika (Slika B).
Approximately 40% of patients in study UC-II had failed prior anti-TNF treatment with infliximab. 
Pri pribliţno 40 % bolnikih v študiji UC-II predhodno anti-TNF zdravljenje z infliksimabom ni bilo uspešno.
Study UV II 
Študija UV II
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neţelenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
• worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness). 
• poslabšanje stanja, ki se imenuje dermatomiozitis (viden kot koţni izpuščaj, ki ga spremlja mišična šibkost).
In study UV II, statistically significant differences were observed for visual acuity only, but the other components were numerically in favour of adalimumab. 
V študiji UV II so opazili statistično pomembne razlike samo za ostrino vida, toda tudi ostale komponente so bile glede številk v korist adalimumaba.
If retreatment with Kromeya is indicated, the above guidance on dose and treatment duration should be followed. 
Če je indicirano vnovično zdravljenje z zdravilom Kromeya, je treba upoštevati zgoraj navedena navodila za odmerjanje in trajanje zdravljena.
After single intravenous doses ranging from 0.25 to 10 mg/kg, concentrations were dose proportional. 
Po enem samem intravenskem odmerku od 0,25 do 10 mg/kg so bile koncentracije sorazmerne odmerku.
2-sided p value from log rank test. 
2-stranska vrednost p testa log-rank.
Partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits. 
Delni zagon bolezni je določen kot ASDAS ≥ 1,3 vendar < 2,1 pri dveh zaporednih obiskih.
The primary efficacy endpoint in both studies was ´time to treatment failure´. 
Primarni opazovani dogodek kot merilo učinkovitosti je bil v obeh študijah ´čas do neuspeha zdravljenja´.
The primary non-responders were excluded from the studies and therefore these patients were not further evaluated. 
Bolniki, ki se prvič niso odzvali, so bili izključeni iz študij in torej niso bili nadaljnje ovrednoteni.
Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells. 
Adalimumab je rekombinantno humano monoklonsko protitelo, pridobljeno v celicah jajčnika kitajskega hrčka.
Warning: Do not use the vial if: 
Opozorilo: Vialo ne uporabljajte, če:
The highest dose level evaluated has been multiple intravenous doses of 10 mg/kg, which is approximately 15 times the recommended dose. 
Največji ocenjeni odmerek je obsegal večkratno intravensko aplikacijo 10 mg/kg, kar je pribliţno 15-kraten priporočen odmerek.
Therapy continued beyond 12 weeks did not result in significantly more responses (see section 4.2). 
Nadaljevanje zdravljenja po 12. tednu ni pokazalo pomembno več odzivov (glejte poglavje 4.2).
Steroid-free remission for ≥ 90 days a 
Remisija brez steroidov za ≥ 90 dni a
Your child's symptoms may return upon stopping treatment. 
Simptomi vašega otroka se lahko po prekinitvi zdravljenja povrnejo.
2.3 Check the liquid to make sure that : The liquid is clear, colorless, and free of particles. 
2.3 Preglejte tekočino in preverite, ali je : bistra, brezbarvna in brez delcev.
You and your doctor should pay special attention to signs of infection while you are being treated with Kromeya. 
Vi sami in vaš zdravnik morata biti posebej pozorna na znake okuţbe, medtem ko ste zdravljeni z zdravilom Kromeya.
After adjustment for weight differences, gender and age appeared to have a minimal effect on adalimumab clearance. 
Po korekciji za razlike v teţi se je izkazalo, da spol in starost po vsem sodeč minimalno vplivata na očistek adalimumaba.
Discontinued corticosteroids 
Prenehanje s kortikosteroidi
Patient reported outcomes regarding vision-related functioning were measured in both clinical studies, using the NEI VFQ-25. 
Izidi poročil bolnikov glede opravil, povezanih z vidom, so bili merjeni v obeh kliničnih študijah z uporabo vprašalnika NEI VFQ -25.
TNF-antagonists, such as adalimumab affect the immune system and their use may affect the body's defence against infection and cancer. 
TNF-antagonisti, kot je adalimumab, prizadenejo imunski sistem in njihova uporaba lahko vpliva na obrambo telesa proti okuţbi in raku.
Among the patients who discontinued the study prior to week 78, 11% discontinued due to adverse events, and 5% due to insufficient response to adalimumab treatment. 
Med bolniki, ki so prekinili študijo pred 78. tednom, jih je 11 % prekinilo študijo zaradi neţelenih učinkov in 5 % zaradi nezadostnega odziva na zdravljenje z adalimumabom.
It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis (see section 5.1). 
Priporočljivo je, da se vsako leto ocenijo koristi in tveganja nadaljnjega dolgotrajnega zdravljenja (glejte poglavje 5.1).
Treatment with Kromeya can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents. 
Zdravljenje z zdravilom Kromeya se lahko začne v kombinaciji s kortikosteroidi in/ali z drugimi nebiološkimi imunomodulatorji.
During the study, most subjects used concomitant MTX, with fewer reporting use of corticosteroids or NSAIDs. 
Med študijo je večina preiskovancev sočasno uporabljala metotreksat, manj pa jih je navedlo uporabo kortikosteroidov ali NSAIDs.
95% confidence intervals for the differences in change scores between methotrexate and adalimumab. 
95 % intervali zaupanja za razlike v spremembi ocen med metotreksatom in adalimumabom na podlagi analize rangov zoţitev sklepne špranje
Your doctor may recommend temporarily stopping Kromeya. 
Vaš zdravnik bo morda priporočil začasno prenehanje uporabe zdravila Kromeya.
The European Medicines Agency has deferred the obligation to submit the results of studies with the reference medicinal product containing adalimumab in one or more subsets of the paediatric population in ulcerative colitis, see section 4.2 for information on paediatric use. 
Evropska agencija za zdravila je začasno odloţila zahtevo za predloţitev rezultatov študij z referenčnim zdravilom, ki vsebuje adalimumab za eno ali več podskupin pediatrične populacije z ulceroznim kolitisom, za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2.
Warning: Do not keep any unused medicine. 
Opozorilo: Neuporabljenega zdravila ne shranjujte.
In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used: 
V primeru, ko je potreben hitrejši odgovor na zdravljenje, z teden zavedanjem, da je tveganje za pojav neţelenih učinkov povečano ob uporabi večjega začetnega odmerka, se lahko uporabi odmerek:
Week 26 Week 52 p value for Standard Dose versus Low Dose comparison. 
26. teden 52. teden p vrednost za primerjavo standardnega odmerka proti majhnemu odmerku.
Formation of antiadalimumab antibodies is associated with increased clearance and reduced efficacy of adalimumab. 
Nastanek protiteles proti adalimumabu spremljata večji očistek in manjša učinkovitost adalimumaba.
Failure to respond to treatment for Crohn's disease may indicate the presence of fixed fibrotic stricture that may require surgical treatment. 
Če se bolnik ne odzove na zdravljenje Crohnove bolezni, lahko to pomeni, da ima stalno fibrotično strikturo, zaradi katere utegne biti potrebno kirurško zdravljenje.
- if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na adalimumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Patients in clinical response (decrease in CDAI ≥ 70) at week 4 were stratified and analysed separately from those not in clinical response at week 4. 
Bolnike s kliničnim odzivom (zmanjšanje CDAI ≥ 70) v 4. tednu so preučili in analizirali ločeno od tistih brez kliničnega odziva v 4. tednu.
• On rare occasions, treatment with Kromeya could result in lupus-like syndrome. 
• V redkih primerih lahko zdravljenje z zdravilom Kromeya povzroči lupusu podoben sindrom.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
VSEBINA, IZRAŢENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression. 
Drugi primeri so obsegali številne različne malignome, med njimi redke malignome, ki so ponavadi povezani z imunosupresijo.
Your doctor may prescribe another strength of Kromeya if your child needs a different dose. 
Zdravnik lahko predpiše vašemu otroku drugo jakost zdravila Kromeya, če vaš otrok potrebuje drugačen odmerek.
Full instructions for use are provided in the package leaflet. 
Podrobna navodila za uporabo so navedena v navodilu za uporabo.
It can now be thrown away in the sharps container. 
Sedaj jo lahko zavrţete v zbiralnik za ostre predmete.
BCVA was either improved or maintained (< 5 letters deterioration) in 88.4% of the eyes at week 78. 
Najboljša korigirana ostrina vida se je ali izboljšala ali pa ohranila (poslabšanje ostrine vida < 5 črk) pri 88,4 % očeh v 78. tednu.
During the withdrawal period, symptoms of psoriasis returned over time with a median time to relapse (decline to PGA “moderate” or worse) of approximately 5 months. 
Med obdobjem prenehanja uporabe so se simptomi psoriaze sčasoma znova pojavili; mediani čas do ponovitve simptomov psoriaze (relapsa) (poslabšanje na PGA "zmerno" ali slabše) je bil pribliţno 5 mesecev.
Percent change in total fingernail NAPSI (%) 
Odstotek spremembe v celotnem indeksu NAPSI
• Children are not allowed to inject themselves and injection must be done by a trained adult. 
• Otroci si zdravila ne smejo injicirati sami, temveč jim ga mora injicirati usposobljena odrasla oseba.
Adalimumab concentrations in the synovial fluid from several rheumatoid arthritis patients ranged from 31-96% of those in serum. 
Koncentracije adalimumaba v sinovijski tekočini več bolnikov z revmatoidnim artritisom so bile od 31 do 96 % tistih v serumu.
No dose adjustment is required. 
Starejši Prilagoditev odmerka ni potrebna.
Of the 371 remaining patients, 276 evaluable patients reached 78 weeks of open-label adalimumab treatment. 
Od preostalih 371 bolnikov je 276 ovrednotenih bolnikov zaključilo 78. tedensko odprto zdravljenje z adalimumabom.
In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult patients. 
Na splošno so bili neţeleni učinki pri pediatričnih bolnikih po pogostnosti in vrsti podobni neţelenim učinkom, opaţenih pri odraslih bolnikih.
Other medicines and Kromeya 
Druga zdravila in zdravilo Kromeya
Detailed instructions on how to inject Kromeya are provided in section 7 ‘Instructions for use'. 
Podrobnejše informacije kako injicirati zdravilo Kromeya so opisane v poglavju 7 “Navodila za uporabo”.
Refer to package leaflet for alternative storage details. 
Za podrobnosti alternativnega shranjevanja glejte navodilo za uporabo.
Exposure-response relationship in paediatric population 
Razmerje med izpostavljenostjo in odzivom pri pediatrični populaciji
Corticosteroids or other medicines that influence the immune system may be continued while using Kromeya. 
Kortikosteroidi ali druga zdravila, ki zavirajo imunski sistem, se lahko še nadalje uporabljajo ob uporabi zdravila Kromeya.
After doses of 0.5 mg/kg (~40 mg), clearances ranged from 11 to 15 mL/hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase half-life was approximately two weeks. 
Po odmerkih 0,5 mg/kg (~40 mg) je bil očistek od 11 do 15 ml/uro, volumen distribucije (Vss) od 5 do 6 litrov in povprečni razpolovni čas terminalne faze pribliţno dva tedna.
The proportions of subjects with PedACR50/70/90 at week 12 and week 24 were 90.3%/61.3%/38.7% and 83.3%/73.3%/36.7%, respectively. 
Deleţi preiskovancev s PedACR50/70/90 so bili 12. teden 90,3 %/61,3 %/38,7 % in 24. teden 83,3 %/73,3 %/36,7 %.
Step 2 Wash your hands 
2. korak Umijte si roke
Patients on adalimumab may receive concurrent vaccinations, except for live vaccines. 
Bolniki, ki prejemajo adalimumab, lahko sočasno dobijo cepiva, razen ţivih cepiv.
• Children under 12 years of age are not allowed to inject themselves and injection must be done by a trained adult. 
• Otroci, mlajši od 12 let, si zdravila ne smejo injicirati sami, temveč jim ga mora injicirati usposobljena odrasla oseba.
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). 
Navidezna koncentracija adalimumaba v plazmi, ki doseţe polovico največje verjetnosti Ped ACR 50 odziva (EC50) je bila 3 μg/ml (95% IZ: 1-6 μg/ml).
Note: Treatment failure at or after week 6 (study UV I), or at or after week 2 (study UV II), was counted as event. 
Opomba: Neuspeh zdravljenja v ali po 6. tednu (študija UV I) ali v ali po 2. tednu (študija UV II) je bil štet kot dogodek.
PGA-F clear/minimal and ≥2-grade improvement (%) 
PGA-F čisto/minimalno in ≥ izboljšanje za dva razreda (%)
An embryo-foetal developmental toxicity/perinatal developmental study has been performed in cynomolgus monkeys at 0, 30 and 100 mg/kg (9-17 monkeys/group) and has revealed no evidence of harm to the foetuses due to adalimumab. 
Raziskava embrio-fetalne razvojne toksičnosti/perinatalnega razvoja je bila narejena pri opicah Cynomologous z odmerki 0,30 in 100 mg/kg (od 9 do 17 opic na skupino) in ni pokazala znakov okvare plodov zaradi adalimumaba.
• unusual infections (which include tuberculosis and other infections) that occur when resistance to disease is lowered; 
• neobičajne okuţbe (vključujejo tuberkulozo in druge okuţbe, ki se pojavijo ob slabši telesni odpornosti na bolezen);
In the open-label period of the study, PASI 75 and PGA clear or minimal responses were maintained for up to an additional 52 weeks with no new safety findings. 
V odprtem obdobju študije so se odzivi PASI 75 in PGA čisto ali minimalno ohranili še do dodatnih 52 tednov brez novih varnostnih ugotovitev.
HR of adalimumab vs placebo from proportional hazards regression with treatment as factor. 
HR adalimumaba v primerjavi s placebom iz regresije proporcionalnih tveganj z zdravljenjem kot faktorjem.
Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Kromeya. 
Kortikosteroide, ki se jih daje sočasno, se lahko postopoma ukinja v skladu s klinično prakso, z začetkom dva tedna po začetku zdravljenja z zdravilom Kromeya.
Take a syringe out of the original box: 
Injekcijsko brizgo vzemite iz originalne ovojnine:
Healthcare professionals are asked to report any suspected adverse reactions. 
Zdravstvene delavce naprošamo, da poročajo o katerem koli domnevnem neţelenem učinku zdravila.
By attaching to TNFα, Kromeya blocks its action and reduces the inflammation in these diseases. 
Z vezavo na TNFα zdravilo Kromeya zaustavi to aktivnost in zmanjša vnetje pri teh boleznih.
Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including adalimumab, who are chronic carriers of this virus (i.e. surface antigen positive). 
Reaktivacijo hepatitisa B so opaţali pri bolnikih, ki so dobivali antagonist TNF (vključno z adalimumabom) in ki so bili kronični nosilci virusa (tj. pozitivni na površinski antigen).
Patients who experience insufficient response may benefit from an increase in dosage: 
Pri bolnikih, ki se ne odzovejo zadostno, se odmerek lahko poveča:
Patients subsequently underwent a mandatory taper schedule, with complete corticosteroid discontinuation by week 19. 
Bolniki so bili kasneje deleţni obveznega programa postopnega zmanjševanja, s popolno ukinitvijo kortikosteroidov do 19. tedna.
Erosion score JSN 
Ocena erozij Seštevek JSN
Kromeya treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Kromeya is indicated. 
Zdravljenje z zdravilom Kromeya mora uvesti in nadzorovati zdravnik specialist, izkušen v diagnosticiranju in zdravljenju bolezni, za katere je zdravilo Kromeya indicirano.
Adalimumab may cross the placenta into the serum of infants born to women treated with adalimumab during pregnancy. 
Adalimumab lahko prehaja skozi placento v serum dojenčkov, ki so jih rodile ţenske, zdravljene z adalimumabom med nosečnostjo.
The Patient Reminder Cards (adult and paediatric) contain the following key elements: - infections, including tuberculosis - cancer - nervous system problems - vaccinations 
Opozorilna kartica za bolnika (za odrasle in otroke) vsebuje naslednje ključne podatke: - okuţbe, vključno s tuberkulozo - rak - teţave ţivčnega sistema - cepljenja