natgillin/translations-raw huggingface dataset:
Common side effects (may affect up to 1 in 10 people): - infection of the respiratory tract, runny or stuffy nose, fungal infections - decrease in the number or size of red blood cells - increase or decrease in the thyroid gland activity, increase of thyroid stimulating hormone, inflammation of the thyroid gland - increase of triglycerides (a type of lipid) in the blood, decreased appetite - aggressive behaviour, feeling depressed, feeling anxious, problems with falling asleep or staying asleep, mood changes, lacking bodily energy or motivation - headache, feeling dizzy, reduced sense of touch or sensation, feeling sleepy, sensation of tingling and ‘pins and needles' - dry eyes - damage of the capillaries (very small blood vessels) in the body - breathing problems 
- zvečanje ali zmanjšanje aktivnosti žleze ščitnice, zvečanje vrednosti tirotropina, vnetje žleze ščitnice, - zvečana raven trigliceridov (vrste lipidov) v krvi, zmanjšan apetit, - agresivno vedenje, občutek depresije, občutek tesnobnosti, težave s spanjem ali začetkom spanja, spremembe razpoloženja, pomanjkanje telesne energije ali motivacije,
Do not inject into skin that is irritated, reddened, bruised, infected or scarred in any way. 
Nikakor ne injicirajte v kožo, ki je razdražena, pordela, podpluta, okužena ali brazgotinasta.
Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen 3 years. 
Besremi 250 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku 3 leta
Each pre-filled pen contains 0.5 mL of solution. 
En napolnjen injekcijski peresnik vsebuje 0,5 ml raztopine.
No dose adaptions for ropeginterferon alfa-2b should be necessary when concomitantly administered with medicinal products metabolised via CYP2C9/19, CYP3A4 or by N-acetyltransferase. 
Ob sočasni uporabi z zdravili, ki se presnavljajo preko CYP2C9/19, CYP3A4 ali N-acetiltransferaze, prilagajanje odmerka ropeginterferona alfa-2b ni potrebno.
Name and address of the manufacturer(s) of the biological active substance(s) PharmaEssentia Corp. 
Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (učinkovin)
The Besremi pre-filled pen comes with two needles. 
Pakiranje napolnjenega injekcijskega peresnika zdravila Besremi vsebuje dve igli.
Package leaflet: Information for the user Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b This medicine is subject to additional monitoring. 
Navodilo za uporabo Besremi 500 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku ropeginterferon alfa-2b Za to zdravilo se izvaja dodatno spremljanje varnosti.
Infections and infestations common respiratory tract infection, rhinitis, fungal skin infection uncommon oral herpes, herpes zoster, oral candidiasis, sinusitis, oesophageal candidiasis, vulvovaginal mycotic infection, hordeolum, onychomycosis 
Infekcijske in parazitske bolezni pogosti okužba zgornjih dihal, rinitis, glivična okužba kože občasni ustni herpes, herpes zoster, ustna kandidoza, sinuzitis,
PT 
PI
The metabolism of ropeginterferon alfa-2b is not fully characterised. 
Presnova ropeginterferona alfa-2b ni popolnoma opredeljena.
Coombs test positive, weight decreased #Reported as adverse reactions during treatment with other interferon alfa medicinal products. 
#V poročilih kot neželeni učinki med zdravljenjem z drugimi zdravili z interferonom alfa.
Uncommon side effects (may affect up to 1 in 100 people): - attempted suicide, thoughts about killing yourself - loss of vision which may be caused by bleeding in the retina (the retina is the light-sensitive layer in the eye), or by build-up of fat in or under the retina 
- izguba vida, ki jo lahko povzroči mrežnična krvavitev (mrežnica je na svetlobo občutljiv sloj v očesu) ali kopičenje maščobe pod ali v mrežnici.
Serious, acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) have been rarely observed with other interferon alfa medicinal products. 
Pri bolnikih, zdravljenih z drugimi zdravili z interferonom alfa, so redko poročali o resnih, akutnih preobčutljivostnih reakcijah (npr. koprivnica, angioedem, bronhokonstrikcija, anafilaksija).
GGT (≥3 times the upper limit of normal) and bilirubin (>2 times the upper limit of normal) levels have been observed in patients treated with ropeginterferon alfa-2b. 
Pri bolnikih, zdravljenih z ropeginterferonom alfa-2b, so opazili zvišanja ravni ALT (≥ 3-krat nad zgornjo mejo normale), AST (≥ 3-krat nad zgornjo mejo normale), GGT (≥ 3-krat nad zgornjo mejo normale) in bilirubina (>2-krat nad zgornjo mejo normale).
Package leaflet: Information for the user Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b This medicine is subject to additional monitoring. 
Navodilo za uporabo Besremi 250 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku ropeginterferon alfa-2b Za to zdravilo se izvaja dodatno spremljanje varnosti.
Immune system disorders uncommon 
Bolezni imunskega sistema občasni
Severe eye disorders such as retinopathy, retinal haemorrhage, retinal exudates, retinal detachment and retinal artery or vein occlusion which may result in blindness have been observed rarely in patients treated with interferon alfa (see section 4.8). 
Vid Pri bolnikih, zdravljenih z interferonom alfa, so redko poročali o hudih boleznih oči, kot so retinopatija, mrežnična krvavitev, mrežnični eksudati, odstop mrežnice in zapora mrežnične arterije ali vene, ki lahko povzročijo slepoto (glejte poglavje 4.8).
Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen Each pre-filled pen of 0.5 mL solution contains 500 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 1,000 micrograms/mL. 
Besremi 500 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku En napolnjen injekcijski peresnik z 0,5 ml raztopine vsebuje 500 mikrogramov ropeginterferona alfa2b, merjeno glede na beljakovine, kar ustreza 1.000 mikrogramom/ml.
Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen Each pre-filled pen of 0.5 mL solution contains 250 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 500 micrograms/mL. 
Besremi 250 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku En napolnjen injekcijski peresnik z 0,5 ml raztopine vsebuje 250 mikrogramov ropeginterferona alfa2b, merjeno glede na beljakovine, kar ustreza 500 mikrogramom/ml.
Ropeginterferon alfa-2b is contraindicated in patients with end stage renal disease (see section 4.3). 
Ropeginterferon alfa-2b je kontraindiciran pri bolnikih s končno ledvično odpovedjo (glejte poglavje
Treatment with ropeginterferon alfa-2b should be discontinued when, despite dose reduction, the increase in liver enzyme levels is progressive and clinically significant. 
Kadar je zvišanje jetrnih encimov napredujoče in klinično pomembno kljub zmanjšanju odmerka, je treba zdravljenje z ropeginterferonom alfa-2b prekiniti.
Very rare side effects (may affect up to 1 in 10,000 people): - idiopathic or thrombotic thrombocytopenic purpura (increased bruising, bleeding, decreased platelets, anaemia and extreme weakness) - myocardial ischemia (reduced blood flow to your heart muscle) 
Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): - idiopatska ali trombotična trombocitopenična purpura (zvečano pojavljanje podplutb, krvavitev,
including suicidal ideation, attempted suicide, aggression, bipolar disorder, mania and confusion have been observed with other interferon alfa medicinal products. 
Pri drugih zdravilih z interferonom alfa so opazili druge učinke na CŽS, vključno s samomorilnimi mislimi, poskusom samomora, agresijo, bipolarno motnjo, manijo in zmedenostjo.
Dose reduced 
SPROŠČANJE SERIJ
Please read this leaflet carefully before using the Besremi 500 micrograms pre-filled pen. 
Navodila za uporabo Pred uporabo zdravila Besremi 500 mikrogramov napolnjen injekcijski peresnik natančno preberite to navodilo.
Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b 
Besremi 500 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku ropeginterferon alfa-2b
Eye disorders common dry eye uncommon retinal haemorrhage#, retinal exudates#, visual impairment, visual acuity reduced, vision blurred, ocular discomfort, eczema eyelids rare retinopathy#, optic neuropathy#, retinal artery occlusion#, retinal vein occlusion#, 
zmanjšana ostrina vida, zamegljen vid, nelagodje v očesu, ekcem na vekah redki retinopatija#, nevropatija vidnega živca#, zapora mrežnične arterije#, zapora mrežnične vene#
Name and address of the manufacturer(s) responsible for batch release AOP Orphan Pharmaceuticals AG 
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
Vascular disorders common microangiopathy uncommon 
Žilne bolezni pogosti mikroangiopatija občasni
Description Besremi 500 micrograms pre-filled pen 
Opis napolnjenega injekcijskega peresnika zdravila Besremi 500 mikrogramov
Ear and labyrinth disorders uncommon deafness, tinnitus, vertigo 
vključno z motnjami labirinta občasni gluhost, tinitus, vrtoglavica
General disorders and administration site conditions very common influenza like illness, fatigue common pyrexia, injection site reaction, asthenia, chills, general physical health deterioration, injection site erythema uncommon injection site pain, injection site pruritus, sensitivity to weather change not known: 
Splošne težave in spremembe na mestu aplikacije zelo pogosti gripi podobna bolezen, utrujenost pogosti pireksija, reakcija na mestu injiciranja, astenija, mrzlica,
Ropeginterferon alfa-2b treatment arm (n=127) 
Značilnosti bolnikov ob presejanju v študiji PROUD-PV Skupina, zdravljenja z ropeginterferonom alfa-2b (n = 127)
Description Besremi 250 micrograms pre-filled pen 
Opis napolnjenega injekcijskega peresnika zdravila Besremi 250 mikrogramov
Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b 
Besremi 250 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku ropeginterferon alfa-2b
The recommended injection site is the abdominal skin around but not within 5 cm of the navel or the thigh. 
Priporočeno mesto injiciranja je koža na trebuhu, ki mora biti od popka ali stegna oddaljena najmanj 5 cm. Ne injicirajte v predele, kjer je koža razdražena, pordela, podpluta, okužena ali brazgotinasta.
Please read this leaflet carefully before using the Besremi 250 micrograms pre-filled pen. 
Navodila za uporabo Pred uporabo zdravila Besremi 250 mikrogramov napolnjen injekcijski peresnik natančno preberite to navodilo.
Liver enzymes and hepatic function should be regularly controlled in patients with longterm ropeginterferon alfa-2b therapy. 
Pri bolnikih na dolgotrajnem zdravljenju z ropeginterferonom alfa-2b je treba redno spremljati jetrne encime in delovanje jeter.
Ask your doctor or pharmacist for advice: - if you are pregnant or breast-feeding. 
Zdravnika ali farmacevta vprašajte za nasvet:
Increased liver enzyme levels have been observed in patients treated with ropeginterferon alfa-2b. 
Pri bolnikih, ki so jih zdravili z ropeginterferonom alfa-2b, so opazili zvišane ravni jetrnih encimov.
In the clinical development program of ropeginterferon alfa-2b, two cases of serious depression (1.1%; incidence rate: 0.4 events/100 patients per year) occurred. 
V programu kliničnega razvoja ropeginterferona alfa-2b je prišlo do 2 primerov resne depresije (1,1
Liver disorders have been reported in patients after long-term ropeginterferon alfa-2b therapy (see section 4.8). 
Po dolgotrajnem zdravljenju z ropeginterferonom alfa-2b so pri bolnikih poročali o boleznih jeter (glejte poglavje 4.8).
Each pre-filled pen of 0.5 mL solution contains 500 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 1,000 micrograms/mL. 
En napolnjen injekcijski peresnik z 0,5 ml raztopine vsebuje 500 mikrogramov ropeginterferona alfa-2b, merjeno glede na beljakovine, kar ustreza 1.000 mikrogramom/ml.
Patients who develop symptoms indicative of a thyroid dysfunction during ropeginterferon alfa-2b therapy, should evaluate their thyroid stimulating hormone (TSH) levels. 
Bolnikom, ki se jim med zdravljenjem z ropeginterferonom alfa-2b pojavijo simptomi, ki kažejo na okvaro delovanja ščitnice,
Enzymes of the protein catabolism are considered to be involved in the metabolism of ropeginterferon alfa-2b. 
V presnovo ropeginterferona alfa-2b so domnevno vpleteni encimi, ki opravljajo razgradnjo beljakovin.
OTHER 
onihomikoza
Water for injections 
Shranjevanje zdravila Besremi
Each pre-filled pen of 0.5 mL solution contains 250 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 500 micrograms/mL. 
En napolnjen injekcijski peresnik z 0,5 ml raztopine vsebuje 250 mikrogramov ropeginterferona alfa-2b, merjeno glede na beljakovine, kar ustreza 500 mikrogramom/ml.
The pharmacokinetic profile of other interferon alfa medicinal products (pegylated interferon alfa-2a and pegylated interferon alfa-2b) was evaluated in renal impaired patients (see section 5.2). 
(pegilirani interferon alfa-2a in pegilirani interferon alfa-2b) (glejte poglavje 5.2).
Very common side effects (may affect more than 1 in 10 people): - decrease in the number of a type of white blood cells (called leucocytes) and in blood clotting cells (called platelets) - joint or muscle pain - flu-like symptoms, feeling tired - in blood tests: increase of an enzyme called gamma-glutamyltransferase 
- zmanjšanje števila vrste belih krvnih celic (imenovanih levkociti) in celic, ki pomagajo pri strjevanju krvi (imenovanih trombociti), - bolečina v sklepih in mišicah,
A reduced starting dose for ropeginterferon alfa-2b of 50 micrograms is recommended for patients with severe (GFR 1529 mL/min) renal impairment. 
29 ml/min) je priporočljivo zmanjšanje začetnega odmerka ropeginterferona alfa-2b na 50 mikrogramov.
Other CNS effects, 
- suhe oči,
Rare side effects (may affect up to 1 in 1,000 people): - bipolar disorders (mood disorders with episodes of sadness and excitement), mania (extreme excitement or unreasonable enthusiasm) - cardiomyopathy (diseases that affect the heart muscle), angina pectoris (a severe chest pain as a result of blockage of the heart vessels) - liver failure 
- bipolarna motnja (spremembe razpoloženja z epizodami žalosti in navdušenja), manija (ekstremno navdušenje ali nerazumljiv entuziazem),
Clear, colourless to pale yellow solution. 
raztopina za injiciranje v napolnjenem injekcijskem peresniku (injekcija) Bistra, brezbarvna do bledo rumena raztopina.
The pharmacokinetic profile of ropeginterferon alfa-2b has not been determined in obese and underweighted patients. 
Pri prekomerno prehranjenih ali podhranjenih bolnikih farmakokinetičnega profila ropeginterferona alfa-2b niso ovrednotili.
No n (%) 
Izboljšanje n (%)
• Remove the cap from the pen. 
• S peresnika odstranite pokrovček.
If you use more Besremi than you should 
Če ste uporabili večji odmerek zdravila Besremi, kot bi smeli Čim prej obvestite zdravnika.
Comparable exposure and pharmacokinetic profile was reported for another interferon alfa medicinal product (pegylated interferon alfa-2a) in cirrhotic (Child-Pugh A) and non-cirrhotic patients. 
Pri drugem zdravilu z interferonom alfa (pegiliran interferon alfa-2a) so pri bolnikih s cirozo (Child
Studies in rats with a similar interferon alfa medicinal product (pegylated interferon alfa-2a) showed a primarily elimination via hepatic metabolism. 
(pegiliran interferon alfa-2a) so pokazale primarno izločanje s presnovo v jetrih.
This overview was last updated in 02-2019. 
Pregled je bil nazadnje posodobljen 02-2019.
It is used to treat the following diseases: 
Uporablja se za zdravljenje naslednjih bolezni:
Further information on Simponi can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/simponi. 
Nadaljnje informacije o zdravilu Simponi so na voljo na spletni strani agencije: ema.europa.eu/en/medicines/human/EPAR/simponi.
It can be used alone or in combination with methotrexate; 
Lahko se uporablja samostojno ali v kombinaciji z metotreksatom;
This was assessed after 6 weeks in the first study and after 54 weeks in the second study. 
To je bilo v prvi študiji ocenjeno po šestih tednih, v drugi pa po 54 tednih.
What measures are being taken to ensure the safe and effective use of Simponi? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Simponi?
Simponi received a marketing authorisation valid throughout the EU on 1 October 2009. 
Za zdravilo Simponi je bilo 1. oktobra 2009 izdano dovoljenje za promet, veljavno po vsej EU.
The European Medicines Agency decided that Simponi's benefits are greater than its risks and that it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Simponi večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The main measure of effectiveness was the number of patients who responded to treatment, based on the number and severity of symptoms. 
Glavno merilo učinkovitosti je bilo število bolnikov, ki so se odzvali na zdravljenje, in je temeljilo na številu in resnosti simptomov.
Other information about Simponi 
Druge informacije o zdravilu Simponi
Why is Simponi authorised in the EU? 
Zakaj je zdravilo Simponi odobreno v EU?
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body. 
Monoklonsko protitelo je protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna posebno strukturo v telesu (imenovano antigen), in se veže nanjo.
What are the risks associated with Simponi? 
Kakšna tveganja so povezana z zdravilom Simponi?
An overview of Simponi and why it is authorised in the EU 
Pregled zdravila Simponi in zakaj je odobreno v EU
This study also showed that patients who received Simponi had greater improvements in carrying out everyday tasks (such as dressing, eating and walking) after 24 weeks. 
Ta študija je tudi pokazala, da se je pri bolnikih, ki so prejemali zdravilo Simponi, sposobnost opravljanja vsakodnevnih opravil (kot so oblačenje, hranjenje in hoja) znatno izboljšala.
Simponi must not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body). 
Zdravilo Simponi se ne sme uporabljati pri bolnikih s tuberkulozo, drugimi hudimi okužbami ali zmernim do hudim srčnim popuščanjem (nezmožnostjo srca, da črpa dovolj krvi po telesu).
As for all medicines, data on the use of Simponi is continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Simponi stalno spremljajo.
Treatment with Simponi and methotrexate was not compared with placebo or any other treatment. 
Zdravljenja z zdravilom Simponi in metotreksatom niso primerjali s placebom ali drugim zdravljenjem.
What benefits of Simponi have been shown in studies? 
Kakšne koristi je zdravilo Simponi izkazalo v študijah?
The most serious side effects include serious infections, such as sepsis (blood infection), pneumonia (lung infection), tuberculosis and infections due to fungi or yeasts, demyelinating disorders (disorders suggesting damage to the protective sheath around nerves, such as changes to vision and weak arms or legs), re-activation of hepatitis B (a disease of the liver due to infection with the hepatitis B virus), congestive heart failure (a heart disease), lupus-like syndrome, blood reactions, severe allergic reactions, vasculitis (inflammation of the blood vessels), and lymphoma and leukaemia (types of cancer of the white blood cells). 
Najpogostejši resni neželeni učinki so hude okužbe, kot je sepsa (okužba krvi), pljučnica (okužba pljuč), tuberkuloza in okužbe zaradi glivic ali kvasovk, demielinizirajoče bolezni (obolenja, ki lahko poškodujejo zaščitno ovojnico okrog živcev, kot so motnje vida in šibke okončine), ponovna aktivacija hepatitisa B (obolenja jeter), kongestivno srčno popuščanje (srčno obolenje), lupusu podoben sindrom, krvne reakcije, hude alergijske reakcije, vaskulitis (vnetje krvnih žil), limfom in levkemija (vrsta raka belih krvnih celic).
By blocking TNF-α, golimumab reduces the inflammation and other symptoms of these diseases. 
Golimumab z zaviranjem snovi TNF- zmanjša vnetje in druge simptome teh bolezni.
What is Simponi and what is it used for? 
Kaj je zdravilo Simponi in za kaj se uporablja?
It is used in children from 2 years of age who have not responded adequately to treatment with methotrexate. 
Uporablja se pri otrocih, starejših od dveh let, ki se niso ustrezno odzvali na zdravljenje z metotreksatom.
For more information about using Simponi, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Simponi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Patients treated with Simponi must be given a reminder card that summarises the safety information about the medicine and when to seek medical advice. 
Bolniki, ki se zdravijo z zdravilom Simponi, morajo prejeti opozorilno kartico, na kateri so povzete informacije o varnosti zdravila in nasveti, kdaj poiskati zdravniško pomoč.
For polyarticular juvenile idiopathic arthritis, 173 patients between 2 and 18 years old who had not responded adequately to treatment with methotrexate were treated for 12 weeks with Simponi and methotrexate. 
Kar zadeva poliartikularni juvenilni idiopatski artritis, so 173 bolnikov, starih od 2 do 18 let, ki se niso ustrezno odzvali na zdravljenje z metotreksatom, 12 tednov zdravili z zdravilom Simponi in metotreksatom.
Side effects reported with Simponi are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Simponi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
It can be used in adults who have not responded adequately to other treatments including methotrexate whose disease is moderate to severe, and in patients who have not previously been treated with methotrexate whose disease is severe and progressive; 
Uporablja se lahko pri odraslih bolnikih, pri katerih je bil odziv na zdravljenje z drugimi zdravili, vključno z metotreksatom, nezadosten in ki imajo zmerno do hudo obliko bolezni, ter pri bolnikih, ki predhodno še niso bili zdravljeni z metotreksatom ter katerih bolezen je huda in napreduje;
The most common side effects with Simponi are upper respiratory tract infections such as infections of the nose, throat or voice box. 
Najpogostejši neželeni učinki zdravila Simponi so okužbe zgornjih dihal, kot so okužbe nosu, žrela ali govornega aparata.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Simponi have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Simponi upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Simponi has been shown to be effective at reducing the number and severity of symptoms in patients with the conditions for which it is authorised. 
Zdravilo Simponi se je izkazalo kot učinkovito pri zmanjševanju števila in resnosti simptomov pri bolnikih z boleznimi, za zdravljenje katerih je bilo odobreno.
Due to an increased risk of infection, patients taking Simponi must be monitored closely for infections, including tuberculosis, during and for up to 5 months after treatment. 
Zaradi povečanega tveganja za okužbo je treba bolnike, ki prejemajo zdravilo Simponi, med zdravljenjem in do pet mesecev po njegovem zaključku skrbno opazovati zaradi morebitnih okužb, ki vključujejo tudi tuberkulozo.
Simponi is used in combination with methotrexate (a medicine that acts on the immune system). 
Zdravilo Simponi se uporablja skupaj z metotreksatom (zdravilom, ki učinkuje na imunski sistem).