natgillin/translations-raw huggingface dataset:
Description Besremi 500 micrograms pre-filled pen 
Opis lijeka Besremi 500 mikrograma napunjene brizgalice
The same elimination route is considered for ropeginterferon alfa-2b. 
Smatra se da je put eliminacije za ropeginterferon alfa-2b isti.
Diabetes mellitus have been observed with other interferon alfa medicinal products (see section 4.8). 
Dijabetes melitus je uočen kod terapije drugim lijekovima koji sadrže interferon alfa (vidjeti dio 4.8).
Very rare side effects (may affect up to 1 in 10,000 people): - blindness - breathing problems including shortness of breath, cough and chest pain which may be caused by lung infiltration, pneumonia (lung infection), pulmonary arterial hypertension (high blood pressure in the blood vessels bringing blood from the heart to the lungs) and pulmonary fibrosis (a lung disease where scars are formed in the lung tissue) 
- poteškoće s disanjem uključujući nedostatak zraka, kašalj i bol u prsima, što može biti uzrokovano plućnim infiltratom, pneumonijom (plućnom infekcijom), hipertenzijom plućne arterije (visoki krvni tlak u krvnim žilama koje vode krv iz srca u pluća) te plućnom fibrozom
Hepatobiliary very common gamma-glutamyltransferase increased disorders common liver disorder, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased uncommon hepatotoxicity, hepatitis toxic, hepatomegaly rare hepatic failure# 
povišena aspartat aminotransferaza, povišena alkalna fosfataza u krvi manje često hepatotoksičnost, toksični hepatitis, hepatomegalija rijetko zatajenje jetre#
Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen 
Besremi 250 mikrograma/0,5 ml otopina za injekciju u napunjenoj brizgalici Besremi 500 mikrograma/0,5 ml otopina za injekciju u napunjenoj brizgalici
Description Besremi 250 micrograms pre-filled pen 
Opis lijeka Besremi 250 mikrograma napunjene brizgalice
Ear and labyrinth disorders uncommon deafness, tinnitus, vertigo 
Poremećaji uha i labirinta manje često gluhoća, tinitus, vrtoglavica
The cartridge is sealed in a pen injector. 
Uložak je učvršćen u brizgalici.
Musculoskeletal and connective tissue disorders very common arthralgia, myalgia common 
Poremećaji mišićno koštanog sustava i vezivnog tkiva vrlo često artralgija, mialgija često
Visual system 
Sustav vida
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: 
Opći poremećaji i reakcije na mjestu primjene vrlo često bolest nalik influenci, umor često pireksija, reakcija na mjestu primjene injekcije, astenija, zimica, pogoršanje općeg tjelesnog zdravstvenog stanja, eritem na mjestu primjene injekcije manje često bol na mjestu primjene injekcije, pruritus na mjestu primjene injekcije, osjetljivost na promjenu vremena nepoznato hiperpigmentacija jezika#
Respiratory, thoracic and mediastinal disorders common dyspnoea uncommon pneumonitis, cough, epistaxis, throat irritation very rare lung infiltration# 
Dispneja manje često pneumonitis, kašalj, epistaksa, iritacija grla vrlo rijetko infiltracija pluća#
Psychiatric disorders common depression, aggression#, insomnia, anxiety, mood altered, mood swings, listless uncommon suicide attempt#, suicidal ideation#, confusional state#, acute stress disorder, hallucination, emotional distress, nervousness, apathy, nightmare, irritability rare bipolar disorder#, mania# 
Psihijatrijski poremećaji često depresija, agresija#, nesanica, tjeskoba, promijenjeno raspoloženje, promjene raspoloženja, bezvoljnost manje često pokušaj suicida#, suicidalna ideacija#, konfuzno stanje #,
Also contains sodium chloride, polysorbate 80, anhydrous sodium acetate, glacial acetic acid, water for injections, and benzyl alcohol. 
POPIS POMOĆNIH TVARI Također sadrži natrijev klorid, polisorbat 80, bezvodni natrijev acetat, ledenu acetatnu kiselinu, vodu za injekcije te benzilni alkohol.
Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen 1.5 years. 
Besremi 500 mikrograma/0,5 ml otopina za injekciju u napunjenoj brizgalici 1,5 godina.
Ropeginterferon alfa-2b is contraindicated in patients with decompensated cirrhosis of the liver (see section 4.3). 
Ropeginterferon alfa-2b je kontraindiciran u bolesnika s dekompenziranom cirozom jetre (vidjeti dio 4.3).
It is not known if Besremi is present in breast milk. 
Nije poznato izlučuje li se Besremi u majčino mlijeko.
- if you are allergic to ropeginterferon alfa-2b or any of the other ingredients of this medicine 
- ako ste alergični na ropeginterferon alfa-2b ili neki drugi sastojak ovog lijeka (naveden u dijelu - ako imate bolest štitnjače koja se ne kontrolira lijekovima.
Nervous system disorders common headache, dizziness, hypoesthesia, somnolence, paraesthesia uncommon polyneuropathy, peripheral motor neuropathy, radiculopathy, migraine, mental impairment, tremor, aura 
Poremećaji živčanog sustava često glavobolja, omaglica, hipoestezija, somnolencija, parestezija manje često polineuropatija, periferna motorička neuropatija,
Besremi contains sodium 
Besremi sadrži natrij
Patients who develop this condition during treatment and cannot be controlled by medicinal products should discontinue ropeginterferon alfa-2b therapy. 
Bolesnici u kojih se dijabetes melitus javi tijekom liječenja i koji se ne mogu kontrolirati lijekovima trebaju prekinuti terapiju ropeginterferonom alfa-2b.
Each pre-filled pen contains 0.5 mL of solution. 
Jedna napunjena brizgalica sadrži 0,5 ml otopine.
Ropeginterferon alfa-2b is contraindicated in patients with end stage renal disease (see section 4.3). 
Ropeginterferon alfa-2b je kontraindiciran u bolesnika sa završnim stadijem bolesti bubrega (vidjeti dio 4.3).
Patients with 36 months of ropeginterferon alfa-2b treatment2 
Bolesnici s 36-mjesečnim liječenjem ropeginterferonom alfa-2b2
Based on the results from the PROUD-PV and CONTINUATION-PV Study on drug exposure, pharmacodynamic response and tolerability, a dose adjustment for ropeginterferon alfa-2b is not considered necessary in the elderly population. 
farmakodinamičkom odgovoru te podnošljivosti, prilagodba doze ropeginterferona alfa-2b ne smatra se potrebnom kod starije populacije.
Serious, acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) have been rarely observed with other interferon alfa medicinal products. 
Akutna preosjetljivost Ozbiljne, akutne reakcije preosjetljivosti (npr. urtikarija, angioedem, bronhokonstrikcija, anafilaksija)
Side effects with frequency not known (cannot be estimated from the available data): - detachment of the retina (you may experience eye problems including changes in vision) 
- odvajanje mrežnice (mogu Vam se javiti problemi s očima uključujući promjene vida)
• Severe pre-existing cardiovascular disease, (i.e. uncontrolled hypertension, congestive heart failure (≥ NYHA class 2), serious cardiac arrhythmia, significant coronary artery stenosis, 
• Postojanje ili anamneza teških psihijatrijskih poremećaja, posebice teške depresije, suicidalne ideacije ili pokušaja samoubojstva • Teška postojeća kardiovaskularna bolest (tj. nekontrolirana hipertenzija, kongestivno zatajenje srca (≥ NYHA klase 2), ozbiljna srčana aritmija, značajna stenoza koronarne arterije, nestabilna angina) ili nedavni moždani udar ili infarkt miokarda
Liver function 
Bubrežna funkcija
Disease response after 24 and 36 months of ropeginterferon alfa-2b. 
Tablica 3. Odgovor na liječenje ropeginterferonom alfa-2b nakon 24 i 36 mjeseci Skupina koja je primala ropeginterferon alfa-2b
In patients who develop evidence of hepatic decompensation during treatment, ropeginterferon alfa-2b should be discontinued. 
U bolesnika u kojih se javi dokaz dekompenzacije jetre tijekom liječenja potrebno je prekinuti terapiju ropeginterferonom alfa-2b.
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 
Infekcije i infestacije često infekcija respiratornog sustava, rinitis, gljivična infekcija kože manje često oralni herpes, herpes zoster, oralna kandidijaza, sinusitis,
112-month treatment duration in the PROUD-PV Study and 12-month treatment duration in the extension study 212-month treatment duration in the PROUD-PV Study and 24-month treatment duration in the extension study 
2 Bolesnici s 12-mjesečnim trajanjem liječenja u ispitivanju PROUD-PV i 24-mjesečnim trajanjem liječenja u produžetku ispitivanja).
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 
Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba): - smanjenje broja bijelih krvnih stanica (zvanih leukociti) i broja stanica koje zgrušavaju krv (zvanih trombociti)
The metabolism of ropeginterferon alfa-2b is not fully characterised. 
Metabolizam ropeginterferona alfa-2b nije do kraja određen.
• Pre-existing thyroid disease unless it can be controlled with conventional treatment 
• Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 • Prethodna bolest štitne žlijezde, osim ako se može kontrolirati standardnim liječenjem
Control treatment arm (n=127) 
(n=127)
Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen The pre-filled pen is made of white polypropylene, with a grey push button and the strength “250 mcg/0.5 mL” highlighted in grey on the label. 
Napunjena brizgalica je načinjena od bijelog polipropilena sa sivim potisnim gumbom i jačinom „250 µg/0,5 ml“ naznačenom sivom bojom na naljepnici.
Renal and urinary disorders uncommon cystitis haemorrhagic, dysuria, micturition urgency, urinary retention 
Poremećaji bubrega i mokraćnog sustava manje često hemoragični cistitis, dizurija, urgencija mokrenja, urinarna retencija
Do not inject into an area where the skin is irritated, reddened, bruised, infected or scarred. 
Nemojte primjenjivati injekciju u područje u kojem je koža nadražena, crvena, s modricama, inficirana ili s ožiljcima.
• Put the cap back on the pen securely. 
• Vratite kapicu natrag na brizgalicu i učvrstite je.
Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen 3 years. 
Besremi 250 mikrograma/0,5 ml otopina za injekciju u napunjenoj brizgalici 3 godine.
• Remove the cap from the pen. 
• Skinite kapicu s brizgalice.
No n (%) 
Ne br (%)
- if you develop signs of a severe allergic reaction (such as difficulty in breathing, wheezing or hives) while using Besremi - if this is the case you will need to seek medical help immediately. 
dok upotrebljavate lijek Besremi - u tom slučaju morate odmah potražiti liječničku pomoć.
CNS 
SŽS
Name and address of the manufacturer(s) of the biological active substance(s) PharmaEssentia Corp. 
Naziv(i) i adresa(e) proizvođača biološke(ih) djelatne(ih) tvari
Besremi 500 mcg/0.5 mL injection ropeginterferon alfa-2b SC 
Besremi 500 μg/0,5 ml injekcija ropeginterferon alfa-2b s.c.
• Do not inject into skin that is irritated, reddened, bruised, infected or scarred in any way. 
• Nemojte injicirati u kožu koja je nadražena, crvena, s modricama, inficirana ili ima bilo kakve ožiljke.
Skin and subcutaneous tissue disorders common pruritus, alopecia, rash, erythema, psoriasis, xeroderma, dermatitis acneiform, hyperkeratosis, hyperhidrosis, dry skin uncommon photosensitivity reaction, skin exfoliation, nail dystrophy not known skin depigmentation# 
Poremećaji kože i potkožnog tkiva često pruritus, alopecija, osip, eritem, psorijaza, kseroderma, akneiformni dermatitis, hiperkeratoza, hiperhidroza,
Do not inject into skin that is irritated, reddened, bruised, infected or scarred in any way. 
Nemojte injicirati u kožu koja je nadražena, crvena, s modricama, inficirana ili ima bilo kakve ožiljke.
Regardless of the starting dose or degree of renal impairment, patients should be monitored. 
Bolesnike treba nadzirati neovisno o početnoj dozi ili stupnju oštećenja bubrega.
Rare side effects (may affect up to 1 in 1,000 people): - loss of vision which may be caused by damage to the retina (such as obstruction of the blood vessels in the eye) or the optic nerve 
- gubitak vida koji može biti uzrokovan oštećenjem mrežnice (poput začepljenja krvnih žila oka)
It should not be injected into an area of the body where the skin is irritated, reddened, bruised, infected or scarred. 
Ne smije se injicirati u područje u kojem je koža iritirana, crvena, s modricama,
Besremi 250 mcg/0.5 mL injection ropeginterferon alfa-2b SC 
Besremi 250 μg/0,5 ml injekcija ropeginterferon alfa-2b s.c.
Patients with 24 months of ropeginterferon alfa-2b treatment1 
Bolesnici s 24-mjesečnim liječenjem ropeginterferenomom alfa-2b1
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 mikrograma/0,5 ml otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica od 0,5 ml otopine sadrži 250 mikrograma ropeginterferona alfa-2b mjereno na bazi proteina što odgovara 500 mikrograma/ml.
CTCAE intensity grade ≥3 N (%) 
CTCAE stupanj intenziteta
• Raise a fold of skin between the thumb and forefinger. 
• Palcom i kažiprstom uhvatite kožu u nabor.
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 mikrograma/0,5 ml otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica od 0,5 ml otopine sadrži 500 mikrograma ropeginterferona alfa-2b mjereno na bazi proteina što odgovara 1000 mikrograma/ml.
PT 
Dob
Gastrointestinal disorders common diarrhoea, nausea, abdominal pain, constipation, abdominal distension, dry mouth uncommon gastritis, abdominal wall disorder, flatulence, frequent bowel movements, odynophagia, gingival bleeding not known tooth disorder#, periodontal disease# 
Poremećaji probavnog sustava često proljev, mučnina, bol u trbuhu, konstipacija, abdominalna distenzija, suhoća usta manje često gastritis, poremećaj abdominalne stijenke, flatulencija,
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) 
smanjen broj trombocita, anemija i ekstremna slabost) - ishemija miokarda (smanjen dotok krvi u srčani mišić)
The absolute bioavailability of subcutaneous administered ropeginterferon alfa-2b was not investigated in humans. 
Apsolutna bioraspoloživost supkutano primijenjenog ropeginterferon alfa-2b nije ispitivana u ljudi pa se stoga nije mogla provesti valjana procjena apsolutne bioraspoloživosti.
Uncommon side effects (may affect up to 1 in 100 people): - infection and re-infection with herpes, bacterial infections - increase in the number of platelets - autoimmune disorder of the thyroid gland, sarcoidosis (areas of inflamed tissue in different parts of the body) - diabetes - panic attack, hallucination (seeing, hearing or feeling things that are not there), feeling stressed, feeling nervous, lack of interest in activities, nightmare, irritability, confusion - damage to the nervous system, migraine, mental disorder (health condition involving changes in thinking, emotion or behaviour), visual or sensory disturbances, shaky hands - eye discomfort, eyelid eczema - hearing loss, ringing in ears (tinnitus), spinning feeling (vertigo) - heart disorders such as heart block (a disorder in the heart´s electrical activity), blood clots in the blood vessels of the heart, leakage of the aortic valve - high blood pressure, reduced blood supply to certain parts of the body, haematoma (collection of blood under the skin), flushing - inflammation of lung tissue, coughing, nosebleed, sore throat - inflammation of the stomach, abdominal wall disorder, intestinal gas, indigestion, painful swallowing, bleeding gums - inflammation of the liver, damage to the liver, enlarged liver - sensitivity to sunlight, peeling of the skin, nail disorder - muscle weakness, neck pain, groin pain - inflammation of the bladder, painful urination, increased need to urinate, inability to urinate - sexual problems - pain or itching at the site of injection, sensitivity to weather change - loss of weight - in blood tests: increase of uric acid, antibodies produced by the body´s immune system against red blood cells 
- upala jetre, oštećenje jetre, uvećana jetra - osjetljivost na sunčevu svjetlost, ljuštenje kože, poremećaj noktiju - mišićna slabost, bol u vratu, bol u preponama - upala mokraćnog mjehura, bolno mokrenje, pojačana potreba za mokrenjem, nemogućnost mokrenja - problemi spolnog sustava - bol ili svrbež na mjestu primjene injekcije, osjetljivost na promjenu vremena - gubitak tjelesne težine
Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b 
Besremi 500 mikrograma/0,5 ml otopina za injekciju u napunjenoj brizgalici ropeginterferon alfa-2b
Ropeginterferon alfa-2b treatment arm 
Ropeginterferon alfa
Each cartridge contains 0.5 mL of solution. 
Jedan uložak sadrži 0,5 ml otopine.
Interaction studies of other pegylated interferon alfa medicinal products Co-administration of pegylated interferon alfa-2a with telbivudine in patients with hepatitis B increased the risk of developing peripheral neuropathy. 
Ispitivanja interakcija drugih pegiliranih interferona alfa Istodobna primjena pegiliranog ropeginterferona alfa-2a s telbivudinom u bolesnika s hepatitisom B
Most common adverse reactions during ropeginterferon alfa-2b treatment. 
Najčešće nuspojave tijekom liječenja ropeginterferonom alfa-2b Klinička ispitivanja s ropeginterferonom alfa-2b
Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b 
Besremi 250 mikrograma/0,5 ml otopina za injekciju u napunjenoj brizgalici ropeginterferon alfa-2b
- diarrhoea, nausea, abdominal pain or stomach discomfort, constipation, dry mouth - liver disorder, increase in certain liver enzymes (shown in blood tests) - itching, hair loss, rash, redness of skin, psoriasis, dry and scaly skin, acne, thickening of the outer layer of the skin, increased sweating - a disorder called Sjogren's syndrome where the body's immune system attacks glands that produce fluid (such as the tear and saliva glands), arthritis, pain in arms and legs, bone pain, painful sudden tightening of a muscle - fever, weakness, chills, general health problems, irritation or redness at the site of injection - in blood tests: antibodies which are produced by the body´s immune system, increase of an enzyme called lactate dehydrogenase 
- proljev, mučnina, bol u trbuhu ili nelagoda, zatvor, suha usta - poremećaj jetre, porast određenih jetrenih enzima (što se vidi u krvnim pretragama) - svrbež, gubitak kose, osip, crvenilo kože, psorijaza, suha i ljušteća koža, akne, zadebljanje vanjskog sloja kože, pojačano znojenje
Complete haematological responsea Complete haematological responsea and improvement in disease burdenb 
Potpuni hematološki odgovora Potpuni hematološki odgovora i poboljšanje u opterećenju bolešćub 52,6 (50/95)
Once a droplet of liquid appears at the needle tip, the pre-filled pen and the needle are working properly. 
napunjena brizgalica i igla rade ispravno.
The dose will be set individually for you by your doctor for your condition. 
Vaš liječnik će na temelju procjene Vaše bolesti odrediti dozu koja je prikladna baš.
No dose adjustment for ropeginterferon alfa-2b is required for adult patients with mild (GFR 6089 mL/min) or moderate (GFR 30-59 mL/min) renal impairment. 
89 ml/min) ili umjerenim oštećenjem (GFR 30-59 ml/min) bubrega.
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. 
Jedna napunjena brizgalica od 0,5 ml otopine sadrži 500 mikrograma ropeginterferona alfa-2b izmjerenog na bazi proteina što odgovara 1000 mikrograma/ml.
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. 
Jedna napunjena brizgalica od 0,5 ml otopine sadrži 250 mikrograma ropeginterferona alfa-2b izmjerenog na bazi proteina što odgovara 500 mikrograma/ml.
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. 
Uputa o lijeku: Informacije za korisnika Besremi 500 mikrograma/0,5 ml otopina za injekciju u napunjenoj brizgalici ropeginterferon alfa-2b
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. 
Uputa o lijeku: Informacije za korisnika Besremi 250 mikrograma/0,5 ml otopina za injekciju u napunjenoj brizgalici ropeginterferon alfa-2b
JAK2V617F allele burden (%)* 41.9±23.49 
Trajanje PV-a (mjeseci)* Opterećenje alelom JAK2V617F
Therefore, care should be taken when ropeginterferon alfa-2b is co-administered with CYP1A2 substrates notably those having a narrow therapeutic margin such as theophylline or methadone. 
Stoga je potreban oprez kada se ropeginterferon alfa-2b uzima istodobno sa supstratima CYP1A2,
Coombs test positive, weight decreased #Reported as adverse reactions during treatment with other interferon alfa medicinal products. 
#Prijavljeno kao nuspojave tijekom liječenja drugim lijekovima koji sadrže interferon alfa.
Vascular disorders common microangiopathy uncommon 
Krvožilni poremećaji često mikroangiopatija manje često
• Discard the pen after use as instructed by your doctor or pharmacist. 
• Nakon uporabe brizgalicu bacite u skladu s uputama
Dental and periodontal disorders 
Poremećaji zubi i parodonta
Acute hypersensitivity 
Potpuni hematološki odgovora
Content (concentration) 
Sastav (koncentraci ja)
It is used to treat the following diseases: 
Primjenjuje se za liječenje sljedećih bolesti:
This overview was last updated in 02-2019. 
Ovaj pregled informacija posljednji je put ažuriran u 2. 2019.
Further information on Simponi can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/simponi. 
Više informacija o lijeku Simponi nalazi se na internetskim stranicama Agencije: ema.europa.eu/en/medicines/human/EPAR/simponi.
Simponi received a marketing authorisation valid throughout the EU on 1 October 2009. 
Simponi je dobio odobrenje za stavljanje u promet koje je na snazi u EU-u od 1. listopada 2009.
This was assessed after 6 weeks in the first study and after 54 weeks in the second study. 
Procjena je provedena nakon šest tjedana u prvom ispitivanju te nakon 54 tjedna u drugom ispitivanju.
The main measure of effectiveness was the number of patients who responded to treatment, based on the number and severity of symptoms. 
Glavno mjerilo učinkovitosti bio je broj bolesnika koji je reagirao na terapiju, na temelju broja i ozbiljnosti simptoma.
By blocking TNF-α, golimumab reduces the inflammation and other symptoms of these diseases. 
Blokadom TNF golimumab smanjuje upalu i druge simptome tih bolesti.
What measures are being taken to ensure the safe and effective use of Simponi? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Simponi?