natgillin/translations-raw huggingface dataset:
Side effects may occur at least up to 4 months after the last AMGEVITA injection.
Neželeni učinki se lahko pojavijo vsaj še 4 mesece po zadnji injekciji zdravila AMGEVITA.
Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from baseline) rates are presented in table 26.
Stopnja klinične remisije in kliničnega odziva (definiran kot zmanjšanje vrednosti PCDAI vsaj za 15 točk od začetne vrednosti) sta predstavljena v preglednici 26.
AMGEVITA is intended for the treatment of the inflammatory diseases described below:
Zdravilo AMGEVITA je namenjeno za zdravljenje vnetnih bolezni, opisanih spodaj:
Week 52 Fistula remission3
52. teden Remisija fistule3
• reactivation of hepatitis B;
• reaktivcija hepatitisa B;
If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted.
Če se sumi na latentno tuberkulozo, se je potrebno posvetovati z zdravnikom, ki ima izkušnje z zdravljenjem tuberkuloze.
Of those in clinical response at week 4, 48% had been previously exposed to other TNF-antagonists.
Od tistih, ki so imeli 4. teden klinični odziv, jih je 48 % predhodno dobilo druge antagoniste TNF.
The corresponding proportions of patients with no radiographic progression were 31.3%, 23.7% and 36.7% respectively.
Ustrezni deleži bolnikov, ki niso imeli rentgenografskih znakov napredovanja, so bili 31.3 %, 23,7 % oz. 36,7 %.
● Alcohol wipes
● Alkoholne zložence
Disease flare criteria were defined as a worsening of ≥ 30% from baseline in ≥ 3 of 6 paediatric ACR core criteria, ≥ 2 active joints, and improvement of > 30% in no more than 1 of the 6 criteria.
Merila zagona bolezni so bila opredeljena kot poslabšanje ≥ 3 od 6 osnovnih meril Pediatric ACR za ≥ 30 % v primerjavi z izhodiščem, ≥ 2 aktivna sklepa in izboljšanje ne več kot 1 od 6 meril za > 30 %.
Treatment with AMGEVITA can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Zdravljenje z zdravilom AMGEVITA se lahko začne v kombinaciji s kortikosteroidi in/ali z drugimi nebiološkimi imunomodulatorji.
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).
1 p value for standard dose versus low dose comparison
*p vrednost za primerjavo standardnega odmerka proti majhnemu odmerku
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 odložila zahtevo za predložitev 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).
In order to improve the traceability of this medicine, your doctor or pharmacist should record the name and the lot number of the product you have been given in your patient file.
Za izboljšanje sledljivosti tega zdravila morata zdravnik ali farmacevt v bolnikovi dokumentaciji zabeležiti ime in serijsko številko zdravila, ki ste ga prejeli.
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 1000 bolnikov) • nizke krvne vrednosti za bele krvne celice, rdeče krvne celice in trombocite.
● Do not put the syringe back in the refrigerator once it has reached room temperature.
● Ne vračajte brizge nazaj v hladilnik, ko je le-ta dosegla sobno temperaturo.
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´.
Hypersensitivity, Allergies (including seasonal allergy)
pogosti preobčutljivost, alergije (vključno s sezonsko alergijo)
The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in table 6 below: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); and not known (cannot be estimated from the available data).
Naslednji seznam neželenih učinkov je osnovan na izkušnjah iz kliničnih preskušanj in iz obdobja trženja zdravila in jih razvršča po organskih sistemih in pogostnosti v preglednici 6, spodaj: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1000 do <1/100), redki (≥1/10000 do <1/1000) in neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
● Do not leave the syringe in direct sunlight.
● Ne izpostavljajte brizge neposredni sončni svetlobi.
The impact of long-term treatment with AMGEVITA on the development of autoimmune diseases is unknown.
Vpliv dolgoročnega zdravljenja z zdravilom AMGEVITA na nastanek avtoimunskih bolezni ni znan.
Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CD study I (CLASSIC I) and CD study II (GAIN).
Indukcijo klinične remisije (opredeljene kot CDAI < 150) so ocenili v dveh študijah, študiji pri Crohnovi bolezni I (CLASSIC I) in študiji pri Crohnovi bolezni II (GAIN).
Time to treatment failure in studies UV I and UV II
Čas do neuspeha zdravljenja v študijah UV I in UV II Analiza
If your doctor determines that methotrexate is inappropriate, AMGEVITA can be given alone.
Če vaš zdravnik ugotovi, da metotreksat ni primeren, lahko zdravilo AMGEVITA dobivate samo.
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 neželenih učinkov in 5 % zaradi nezadostnega odziva na zdravljenje z adalimumabom.
-56.2a a p < 0.001, adalimumab versus placebo
-56,2a a p < 0,001, adalimumab v primerjavi s placebom
• If you receive AMGEVITA during your pregnancy, your baby may have a higher risk for getting an infection.
• Če prejemate zdravilo AMGEVITA med nosečnostjo, obstaja večje tveganje, da bo vaš dojenček dobil okužbo.
Ps study II (CHAMPION) efficacy results at 16 weeks Placebo N = 53 n (%)
Študija pri psoriazi II (CHAMPION) - Rezultati učinkovitosti po 16 tednih placebo N = 53 n (%)
If retreatment with AMGEVITA is indicated, the above guidance on dose and treatment duration should be followed.
Če je indicirano vnovično zdravljenje z zdravilom AMGEVITA, je treba upoštevati zgoraj navedena navodila za odmerjanje in trajanje zdravljena.
Efficacy of adalimumab for the treatment of adolescent patients with HS is predicted based on the demonstrated efficacy and exposure-response relationship in adult HS patients and the likelihood that the disease course, pathophysiology, and drug effects are substantially similar to that of adults at the same exposure levels.
Učinkovitost adalimumaba za zdravljenje mladostnikov s HS je napovedana na podlagi dokazane učinkovitosti in razmerja med izpostavljenostjo in odzivom pri odraslih bolnikih s HS ter verjetnosti, da so potek bolezni, patofiziologija in učinek zdravila bistveno podobni kot pri odraslih bolnikih, pri enaki ravni izpostavljenosti.
Do not use AMGEVITA:
Ne uporabljajte zdravila AMGEVITA:
You should not take AMGEVITA with medicines containing the active substances, anakinra or abatacept due to increased risk of serious infection.
Zdravila AMGEVITA ne smete jemati z zdravili, ki vsebujejo učinkovini anakinro ali abatacept zaradi povečanega tveganja za resne okužbe.
Before initiation of therapy with AMGEVITA, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
Pred začetkom zdravljenja z zdravilom AMGEVITA je vse bolnike treba pregledati glede aktivne ali neaktivne (latentne) tuberkulozne okužbe.
In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding.
• Pri nekaterih bolnikih telo ne ustvari dovolj krvnih celic, ki pomagajo pri premagovanju okužbe ali ustavitvi krvavitve.
Formation of antiadalimumab antibodies is associated with increased clearance and reduced efficacy of adalimumab.
Nastanek protiteles proti adalimumabu je povezano z večjim očistkom in manjšo učinkovitostjo adalimumaba.
If you have or develop demyelinating disease such as multiple sclerosis, your doctor will decide if you should receive or continue to receive AMGEVITA.
• Če imate ali pa se pri vas razvija demielinizirajoča bolezen, kot je multipla skleroza, bo zdravnik presodil, ali lahko dobivate oziroma tudi še nadalje dobivate zdravilo AMGEVITA.
● If you have psoriasis, you should avoid injecting directly into raised, thick, red, or scaly skin patch or lesion.
● Če imate luskavico, se morate izogibati injiciranju neposredno v dvignjen, zadebeljen, pordel ali luskast predel kože ali lezijo.
Concomitant administration of AMGEVITA with other biologic DMARDS (e.g. anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions (see section 4.5).
Sočasna uporaba zdravila AMGEVITA z drugimi biološkimi DMARDS (t.j.anakinra in abacept) ali z drugimi antagonisti TNF ni priporočljiva zaradi možnega povečanega tveganja za okužbe, vključno z resnimi okužbami, in drugih potencialnih farmakoloških interakcij (glejte poglavje 4.5).
RA studies III and V had an additional primary endpoint at 52 weeks of retardation of disease progression (as detected by x-ray results).
V študijah III in V je bila dodatna primarna končna točka po 52 tednih upočasnitev napredovanja bolezni (ugotovljena z izvidi rentgenskega slikanja).
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.
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 doseže polovico največje verjetnosti PedACR 50 odziva (EC50) je bila 3 µg/ml (95 % IZ: 1-6 µg/ml).
Cases of worsening congestive heart failure have also been reported in patients receiving adalimumab.
O primerih poslabšanja kongestivnega srčnega popuščanja so prav tako poročali pri bolnikih, ki so prejemali adalimumab.
Other medicines and AMGEVITA
Druga zdravila in zdravilo AMGEVITA
Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with AMGEVITA.
Kortikosteroide, ki se jih daje sočasno, se lahko postopoma ukinja v skladu s klinično prakso, z začetkom dva tedna po začetku zdravljenja z zdravilom AMGEVITA.
Firmly push the pre-filled pen down onto the skin until it stops moving.
Trdno pritisnite napolnjeni injekcijski peresnik ob kožo, dokler se ne neha premikati.
AMGEVITA can also be given alone.
Zdravilo AMGEVITA se lahko daje tudi samo.
In CD study III, at week 4, 58% (499/854) of patients were in clinical response and were assessed in the primary analysis.
V študiji pri Crohnovi bolezni III je imelo 4. teden klinični odziv 58 % (499/854) bolnikov; ti so bili ocenjeni v primarni analizi.
• immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis);
• imunske bolezni, ki lahko prizadanejo pljuča, kožo in limfne vozle (najpogosteje kot sarkoidoze);
In all cases, use a new syringe.
V vseh the primerih uporabite novo brizgo.
Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with AMGEVITA (see section 4.4).
Oftalmologom se svetuje, da se pred začetkom zdravljenja z zdravilom AMGEVITA posvetujejo z ustreznim specialistom (glejte poglavje 4.4).
Re-introduction of AMGEVITA after discontinuation for 70 days or longer should result in the same magnitudes of clinical response and similar safety profile as before dose interruption.
Zdravilo AMGEVITA bi moralo po ponovni uvedbi, ki je sledila prekinitvi za 70 dni ali več, doseglo enako velik klinični odziv in je imelo podobne varnostne značilnosti kot pred prekinitvijo.
• You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last AMGEVITA treatment.
• Premisliti morate o uporabi ustrezne kontracepcijske zaščite za preprečitev nosečnosti in z njo nadaljevati vsaj še 5 mesecev po zadnjem zdravljenju z zdravilom AMGEVITA.
You should continue to inject AMGEVITA for as long as your doctor has told you.
Nadaljevati morate z injiciranjem zdravila AMGEVITA tako dolgo, kot vam je naročil zdravnik.
In post-marketing experience from January 2003 to December 2010, predominantly in patients with rheumatoid arthritis, the reported rate of malignancies is approximately 2.7 per 1,000 patient treatment years.
V obdobju trženja zdravila od januarja 2003 do decembra 2010, pretežno pri bolnikih z revmatoidnim artritisom, je bil zabeleženi delež malignomov približno 2,7 na 1000 bolnikov-let zdravljenja.
Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of AMGEVITA in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
O uporabi protituberkuloznega profilaktičnega zdravljenja se mora pred uvedbo zdravila AMGEVITA razmisliti tudi pri bolnikih s hudimi ali pomembnimi faktorji tveganja za tuberkulozo kljub negativnemu testu za tuberkulozo in pri bolnikih z anamnezo latentne ali aktivne tuberkuloze, pri katerih ni mogoče potrditi ustreznega zdravljenja.
It is important that you tell your baby's doctors and other health care professionals about your AMGEVITA use during your pregnancy so they can decide when your baby should receive any vaccine.
Zato je pomembno, da obvestite zdravnika vašega otroka in druge zdravstvene delavce, da ste med nosečnostjo prejemali zdravilo AMGEVITA, da se lahko odločijo, kdaj bo vaš otrok lahko prejel katerokoli cepivo.
If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of AMGEVITA, and in accordance with local recommendations.
Če se ugotovi latentna tuberkuloza, se mora pred uvedbo zdravila AMGEVITA začeti s protituberkuloznim profilaktičnim zdravljenjem v skladu z lokalnimi priporočili.
AMGEVITA is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Zdravilo AMGEVITA se uporablja za zdravljenje Crohnove bolezni pri odraslih in otrocih, starih 6 do 17 let.
c Ankylosing Spondylitis Disease Activity Score d Partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
d Delni zagon bolezni je določen kot ASDAS ≥ 1,3 vendar < 2,1 pri dveh zaporednih obiskih.
The frequency of serious infections among adalimumab-treated subjects over 65 years of age (3.7%) was higher than for those under 65 years of age (1.5%).
Pri bolnikih nad 65 let, ki so prejemali adalimumab, je bila pogostost resnih okužb večja (3,7 %) kot pri tistih pod 65 let starosti (1,5 %).
At week 16, a statistically significantly greater proportion of patients who received adalimumab achieved PGA of 'clear' or 'almost clear' for the hands and/or feet compared to patients who received placebo (30.6% versus 4.3%, respectively [P = 0.014]).
V 16. tednu je statistično pomembno večji delež bolnikov, ki so prejemali adalimumab, doseglo PGA ‘'čisto'' ali ‘'skoraj čisto'' za dlani in/ali stopala, v primerjavi z bolniki, ki so prejemali placebo (30,6 % proti 4,3 %, v tem zaporedju [P = 0,014]).
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 NSAID.
The active ingredient in AMGEVITA, adalimumab, is a human monoclonal antibody.
Učinkovina v zdravilu AMGEVITA, adalimumab, je humano monoklonsko protitelo.
This includes any possible side effects not listed in this leaflet (see section 4).
Posvetujte se tudi, če opazite katerekoli neželene učinke, ki niso navedeni v tem navodilu (glejte poglavje 4).
D. Prepare and clean your injection site.
D. Pripravite in očistite mesto injiciranja.
Treatment with AMGEVITA should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Zdravljenja z zdravilom AMGEVITA se ne sme začeti pri bolnikih z aktivnimi okužbami, vključno s kroničnimi ali lokaliziranimi, dokler te niso obvladane.
Name and address of the manufacturers of the biological active substance Amgen Inc
Ime in naslov izdelovalcev biološke učinkovine Amgen Inc
If you use more AMGEVITA than you should
Če ste uporabili večji odmerek zdravila AMGEVITA, kot bi smeli
Certain vaccines may cause infections and should not be given while receiving AMGEVITA.
• Določena cepiva lahko povzročijo okužbe, zato se jih med zdravljenjem z zdravilom AMGEVITA ne sme uporabljati.
As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting AMGEVITA.
• Ker so bili pri bolnikih, zdravljenih z adalimumabom, opisani primeri tuberkuloze, vas bo zdravnik pred začetkom zdravljenja z zdravilom AMGEVITA preiskal glede znakov in simptomov tuberkuloze.
Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab (see section 4.8).
Poročali so tudi o melanomu in karcinomu Merkelovih celic pri bolnikih, zdravljenih z TNF-antagonisti, vključno z adalimumabom (glejte poglavje 4.8).
At week 12, a significantly higher proportion of patients in study HS-II experienced a clinically relevant decrease in HS-related skin pain (see table 21).
V 12. tednu je statistično pomembno večji delež bolnikov v študiji HS-II občutil klinično pomembno zmanjšanje bolečine na koži, povezane s HS (glejte preglednico 21).
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.
Deleži preiskovancev s PedACR50/70/90 so bili 12. teden 90,3 %/61,3 %/38,7 % in 24. teden 83,3 %/73,3 %/36,7 %.
Adalimumab significantly delayed the time to treatment failure, as compared to placebo (see figure 3, P < 0.0001 from log rank test).
Adalimumab je značilno podaljšal čas do neuspeha zdravljenja v primerjavi s placebom (glejte sliko 3, p < 0,0001 iz testa log-rank).
No dose recommendations can be made.
Priporočila glede odmerjanja niso možna.
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.
Due to its inhibition of TNFα, adalimumab administered during pregnancy could affect normal immune responses in the new born.
Ker adalimumab zavira TNFα, bi njegova uporaba med nosečnostjo lahko okrnila normalne imunske odzive novorojenčka.
These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections and sepsis that may, in rare cases, be life-threatening.
Te okužbe so lahko resne in vključujejo tuberkulozo, okužbe, ki jih povzročijo virusi, glive, paraziti ali bakterije ali druge oportunistične okužbe, in sepso, in so lahko v redkih primerih smrtno nevarne.
● Do not try to warm the syringe by using a heat source such as hot water or microwave.
● Ne poskušajte ogrevati brizge z virom toplote, kot na primer z vročo vodo ali v mikrovalovni pečici.
At week 12 and week 24, PedACR30 response was 93.5% and 90.0%, respectively, using the observed data approach.
12. teden je bil odziv PedACR30 93,5 % in 24. teden 90,0 % (z uporabo pristopa z opaženimi podatki).
Similar trends (not all statistically significant) were seen in the smaller randomised, double-blind, placebo controlled AS study II of 82 adult patients with active ankylosing spondylitis.
Podobni trendi (ki pa niso bili vsi statistično značilni) so bili opazni v manjši, randomizirani, dvojno slepi, s placebom kontrolirani študiji pri ankilozirajočem spondilitisu II pri 82 odraslih bolnikih z aktivnim ankilozirajočim spondilitisom.
When done, release your thumb, and gently lift the syringe off of your skin.
I. Ko ste opravili, odmaknite palec in brizgo previdno dvignite od kože.
In patients who develop HBV reactivation, AMGEVITA should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Pri bolnikih, ki se jim pojavi reaktivacija HBV, je treba uporabo zdravila AMGEVITA prekiniti in uvesti učinkovito protivirusno terapijo z ustreznim podpornim zdravljenjem.
If active tuberculosis is diagnosed, AMGEVITA therapy must not be initiated (see section 4.3).
Če se odkrije aktivna tuberkuloza, se zdravljenja z zdravilom AMGEVITA ne sme začeti (glejte poglavje 4.3).
Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), paediatric ACR 50 response, and paediatric ACR 70 response.
Čeprav ni statistično značilno, je bilo pri večini bolnikov dokazano klinično izboljšanje sekundarnih opazovanih dogodkov, kot so število mest entezitisa, število občutljivih sklepov, število oteklih sklepov, odziv glede na merila Pediatric ACR 50 in Pediatric ACR 70.
Figure 2: Kaplan-Meier curves summarising time to treatment failure on or after week 6 (study UV I) or week 2 (study UV II)
Slika 2: Kaplan-Meier-jeve krivulje povzemajo čas do neuspeha zdravljenja v ali po 6. tednu (študija UV I) ali 2. tednu (študija UV II)
Patients were permitted to be either disease-modifying, antirheumatic drug-naïve or to remain on their pre-existing rheumatologic therapy provided that therapy was stable for a minimum of 28 days.
Bolniki lahko pred tem še niso prejemali imunomodulirajočih antirevmatičnih zdravil ali pa so ohranili svojo prejšnjo revmatološko terapijo pod pogojem, da je bila ta terapija stabilna vsaj 28 dni.
Percent change in total fingernail NAPSI (%)
Odstotek spremembe v celem indeksu NAPSI
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Pred uporabo natančno preberite navodilo, ker vsebuje pomembne podatke!
- On rare occasions, treatment with AMGEVITA could result in lupus-like syndrome.
• V redkih primerih zdravljenje z zdravilom AMGEVITA lahko povzroči lupusu podoben sindrom.
• AMGEVITA should only be used during a pregnancy if needed.
• Zdravilo AMGEVITA se med nosečnostjo lahko uporablja samo, če je potrebno.
vision related effects were not numerically in favour of adalimumab for colour vision in study UVI and for colour vision, peripheral vision and near vision in study UV II.
Učinki povezani z vidom niso bili v korist adalimumabu v primeru barvnega vida v študiji UV I in v primeru barvnega vida, perifernega vida in vida na blizu v študiji UV II.