natgillin/translations-raw huggingface dataset:
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 March 2017 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 22. marec 2017
Median time to failure (months) 
Srednji čas do neuspeha (meseci)
Wash your hands thoroughly with soap and water. 
Dobro si umijte roke z milom in vodo.
Always take the outer carton of this medicine with you, even if it is empty. 
Vedno vzemite s seboj zunanjo ovojnino zdravila, tudi če je prazna.
Tell your healthcare provider if you are allergic to latex. 
Povejte zdravstvenemu delavcu, če ste alergični na lateks.
This is part of the syringe. 
To je del brizge.
Most side effects are mild to moderate. 
Večina stranskih učinkov je blagih do zmernih.
Particular attention regarding the risk for infection should be paid when treating the elderly. 
Posebna pozornost glede tveganja okužb je potrebana pri zdravljenju starejših.
You will also need these additional items, as they are not included in the carton: 
Potrebovali boste tudi ta dodaten material, ki pa ni vključen v škatli:
if you have moderate or severe heart failure. 
• če imate zmerno ali hudo srčno popuščanje.
Keep pushing down on your skin. 
Še naprej pritiskajte ob kožo.
CI 95% for HRa 
IZ 95 % za RTa
Blue start button 
Modri sprožilni gumb
- Any part appears cracked or broken. 
- Se kateri koli del zdi zdrobljen ali zlomljen.
You and your doctor should pay special attention to signs of infection while you are being treated with AMGEVITA. 
Vi sami in vaš zdravnik morata biti posebej pozorna na znake okužbe, medtem ko ste zdravljeni z zdravilom AMGEVITA.
● If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection. 
● Če želite uporabiti isto mesto za injiciranje, se prepričajte, da ne boste injicirali na isti točki kot ste pri predhodnem injiciranju.
When you are ready to inject, press the blue start button. 
I. Ko ste pripravljeni na injiciranje, pritisnite modri sprožilni gumb.
OTHER SPECIAL WARNING(S), IF NECESSARY Contains latex, read the package leaflet before use. 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Vsebuje lateks, pred uporabo preberite priloženo navodilo.
Important: Do not touch the blue start button yet. 
Pomembno: Ne dotikajte se še modrega sprožilnega gumba.
Disease flares at the end of 32 weeksa (n/N) 
Zagon bolezni na koncu 32-tedenskega obdobjaa (n/N)
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
Kot vsa zdravila lahko tudi to zdravilo povzroči neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
This leaflet was last revised in 
To navodilo je bilo nazadnje revidirano dne
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli za “EXP”.
≥30% Reduction in Skin Painb 
≥ 30 % zmanjšanje bolečine na koži b
Apply a plaster if needed. 
Če je treba, namestite obliž.
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. 
Dovoljena je bila sočasna uporaba stabilnih odmerkov aminosalicilatov, kortikosteroidov in/ali imunomodulacijskih zdravil; 80 % bolnikov je še naprej prejemalo vsaj eno od takšnih zdravil.
● Talk with your doctor or pharmacist about proper disposal. 
● Z zdravnikom ali farmacevtom se posvetujte o pravilnem odlaganju.
It is normal to see a drop of liquid at the end of the needle. 
Normalno je, da se na koncu igle pokaže kapljica tekočine.
After 32 weeks or at disease flare, patients were eligible to enrol into the open-label extension phase. 
Po 32 tednih ali v primeru zagona bolezni so bili bolniki primerni za vključitev v odprto podaljšano fazo.
if you have a severe infection, including active tuberculosis (see “Warnings and precautions”). 
• če imate hudo okužbo, vključno z aktivno tuberkulozo (glejte "Opozorila in previdnostni ukrepi").
TNF-antagonists, such as AMGEVITA affect the immune system and their use may affect the body's defence against infection and cancer. 
TNF-antagonisti, kot je zdravilo AMGEVITA, prizadanejo imunski sistem in njihova uporaba lahko vpliva na obrambo telesa proti okužbi in raku.
The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and non-randomised design. 
Na interpretacijo podatkov lahko vplivajo metodološke omejitve raziskave, vključno z majhno velikostjo vzorca in nerandomizirano zasnovo raziskave.
The expiry date refers to the last day of that month. 
Rok uporabe zdravila se izteče na zadnji dan navedenega meseca.
Dry natural rubber 
Suha naravna guma
• According to a pregnancy study, there was no higher risk of birth defects when the mother had received AMGEVITA during pregnancy compared with mothers with the same disease who did not receive AMGEVITA. 
• Glede na študije v nosečnosti ni bilo večjega tveganja za defekte ob rojstvu, če je mati jemala zdravilo AMGEVITA med nosečnostjo, v primerjavi z materami z enako boleznijo, ki zdravila AMGEVITA niso jemale.
Important: You must push all the way down but do not touch the blue start button until you are ready to inject. 
Pomembno: Potisniti morate do konca dol, vendar se ne dotikajte modrega sprožilnega gumba, dokler niste pripravljeni na injiciranje.
73% of patients enrolled in psoriasis studies I and II had received prior systemic therapy or phototherapy. 
73 % bolnikov, vključenih v študiji pri psoriazi I in II, je predhodno dobivalo sistemsko zdravljenje ali fototerapijo.
The primary endpoint of the study was clinical remission at week 26, defined as PCDAI score ≤ 10. 
Primarni cilj študije je bila klinična remisija v 26.tednu, definirana kot vrednost PCDAI ≤ 10.
Maintenance regimen 
Vzdrževalni režim
● Do not use any medicine that is left in the used syringe. 
● Ne uporabite zdravila, ki je ostalo v uporabljeni brizgi.
Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis)1), 
pogosti poslabšanje ali pojav psoriaze (vključno s palmplantarno pustularno psoriazo)1),
HS study II 
Študija HS II
H. Using slow and constant pressure, push the plunger rod all the way down until it stops moving. 
H. S počasnim in enakomernim pritiskom potisnite bat brizge do konca dol, dokler se ne preneha premikati.
Grab Here 
Primite tukaj
Limited information from the published literature indicates that adalimumab is excreted in breast milk at very low concentrations with the presence of adalimumab in human milk at concentrations of 0.1% to 1% of the maternal serum level. 
Omejeni podatki iz objavljene literature kažejo, da se adalimumab izloča v materino mleko v zelo nizkih koncentracijah, s prisotnostjo adalimumaba v človeškem mleku v koncentraciji 0,1 % do 1 % glede na materin serum.
Clean your injection site with an alcohol wipe. 
Očistite mesto injiciranja z alkoholnim zložencem.
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 kožni test in rentgensko slikanje prsnih organov) (veljajo lahko lokalna priporočila).
If you forget to give yourself an injection, you should inject the next dose of AMGEVITA as soon as you remember. 
Če si pozabite dati injekcijo, si jo morate naslednji odmerek zdravila AMGEVITA injicirati, čim se spomnite.
Efficacy results at 12 weeks, HS studies I and II 
Rezultati učinkovitosti v 12. tednu, HS študiji I in II Študija HS I
- 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 katerokoli sestavino tega zdravila, navedeno v poglavju 6.
• opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered); 
• oportunistične okužbe (ki vključujejo tuberkulozo in druge okužbe, ki se pojavijo ob slabši telesni odpornosti na bolezen);
C. Gather all materials needed for your injection. 
C. Pripravite ves material, potreben za injiciranje.
This will include a thorough medical evaluation including your medical history and appropriate screening tests (for example chest x-ray and a tuberculin test). 
To bo vključevalo natančno zdravniško oceno vključno s poizvedbo o vašem zdravju v preteklosti in ustrezne preiskave (npr. rentgensko slikanje prsnih organov in tuberkulinski test).
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 Chronove bolezni pri pediatričnih bolnikih je nadaljevalo v odprti dolgoročni podaljšani študiji.
The decision to stop using AMGEVITA should be discussed with your doctor. 
O odločitvi, da bi prenehali uporabljati zdravilo AMGEVITA, se morate posvetovati s svojim zdravnikom.
a HR of adalimumab versus placebo from proportional hazards regression with treatment as factor. 
a RT adalimumaba v primerjavi s placebom iz regresije proporcionalnih tveganj z zdravljenjem kot faktorjem.
PGA-F clear/minimal and ≥ 2-grade improvement 
PGA-F čisto/minimalno in ≥ izboljšanje za dva razreda (%)
* further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open-label extension studies 
* Nadaljnje informacije v zvezi s tem najdete v poglavjih 4.3, 4.4 in 4.8 ** Vključno pri podaljšanih študijah brez placeba 1)Vključno s podatki iz spontanega poročanja
6.6 Special precautions for disposal and other handling Detailed instructions for use are provided in the package leaflet. 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Podrobna navodila za uporabo so na voljo v Navodilu za uporabo.
In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening. 
V redkih primerih, zlasti če uporabljate druga zdravila, ki zavirajo imunski sistem, je reaktivacija HBV lahko smrtno nevarna.
Advise your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of contracting HBV. 
• Zdravniku morate povedati, če ste nosilec virusa hepatitisa B (HBV), če imate aktiven HBV ali če mislite, da bi se lahko nalezli HBV.
Ps study IV efficacy results at 16, 26 and 52 weeks 
Študija pri psoriazi IV Rezultati učinkovitosti po 16, 26 in 52 tednih Končna točka
If you received AMGEVITA while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately five months after the last dose you received during pregnancy. 
Če ste prejemali zdravilo AMGEVITA med nosečnostjo, obstaja večje tveganje, da bo vaš otrok dobil takšno okužbo do približno pet mesecev po zadnjem odmerku, ki ste ga prejeli med nosečnostjo.
Your doctor may recommend temporary discontinuation of AMGEVITA. 
Vaš zdravnik bo morda priporočil začasno prenehanje uporabe zdravila AMGEVITA.
Urticaria, 
urtikarija,
Carefully lift the pre-filled pen straight up out of the box. 
Previdno dvignite napolnjeni injekcijski peresnik naravnost iz škatle.
Clinical response is usually achieved within 2-8 weeks of treatment. 
Klinični odziv je po navadi dosežen v 2-8 tednih zdravljenja.
> 32 weeks 
> 32 tednov
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.
AMGEVITA in combination with methotrexate, is indicated for: 
Zdravilo AMGEVITA je v kombinaciji z metotreksatom indicirano za:
If you are over 65 years you may be more susceptible to infections while taking AMGEVITA. 
• Če ste starejši od 65 let, ste morda dovzetnejši za okužbe, če jemljete zdravilo AMGEVITA.
Bruising (including purpura), 
modrice (vključno s purpuro),
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).