FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: PROUD-PV in CONTINUATION-PV, prilagajanje odmerka ropeginterferona alfa-2b pri starejših ni potrebno.
English: The pre-filled pen may be stored for a maximum of 30 days in the refrigerator (2 °C - 8 °C) when stored with the pen cap on and kept in the outer carton in order to protect from light.
Slovenian: Po prvi uporabi Napolnjen injekcijski peresnik lahko shranjujete v hladilniku (2 °C - 8 °C) največ 30 dni, če je shranjen z nameščenim pokrovčkom peresnika in v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Patients with 24 months of ropeginterferon alfa-2b treatment1
Slovenian: Bolniki s 24 meseci zdravljenja z ropeginterferonom alfa-2b1
English: Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen The pre-filled pen is made of white polypropylene, with a blue push button and the strength “500 mcg/0.5 mL” highlighted in blue on the label.
Slovenian: Besremi 500 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Napolnjen injekcijski peresnik je izdelan iz belega polipropilena in ima moder potisni gumb, na nalepki pa ima z modro označeno jakost “500 mcg/0,5 ml”.
English: In patients who develop evidence of hepatic decompensation during treatment, ropeginterferon alfa-2b should be discontinued.
Slovenian: Pri bolnikih, pri katerih med zdravljenjem pride do dokazane dekompenzacije jeter, je treba zdravljenje z ropeginterferonom alfa-2b prekiniti.
English: - if you have liver problems − you will have blood tests regularly to check how your liver is working if you are on a long-term Besremi therapy.
Slovenian: - če imate sladkorno bolezen ali visok krvni tlak - zdravnik vam bo morda naročil, da greste na očesni pregled; - če imate težave z jetri - če ste na dolgotrajnem zdravljenju z zdravilom Besremi, vam bodo redno opravljali preiskave krvi za preverjanje delovanja vaših jeter; - če imate težave z ledvicami;
English: The dose was gradually increased depending on disease response and tolerability (for ropeginterferon alfa-2b, from 50 to
Slovenian: Odmerek so postopoma zvečevali glede na odziv na zdravljenje in prenašanje (pri ropeginterferonu alfa-2b so dajali od 50 do 500 mikrogramov subkutano vsaka dva tedna).
English: Patients with 36 months of ropeginterferon alfa-2b treatment2
Slovenian: Bolniki s 36 meseci zdravljenja z ropeginterferonom alfa-2b2
English: Side effects with frequency not known (cannot be estimated from the available data): - Vogt-Koyanagi-Harada disease (a rare disease that can lead to loss of vision, hearing and skin pigmentation), severe allergic reaction - discolouration of the skin
Slovenian: - Vogt-Koyanagi-Haradova bolezen (redka bolezen, ki lahko povzroči izgubo vida, sluha in obarvanosti kože), huda alergijska reakcija, - obarvanje kože, - bolezni zob in obzobnih tkiv (prizadenejo dlesni), sprememba barve jezika.
English: Sodium chloride Sodium acetate, anhydrous Acetic acid, glacial Benzyl alcohol Polysorbate 80
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev klorid brezvodni natrijev acetat koncentrirana ocetna kislina benzilalkohol polisorbat 80 voda za injekcije
English: Disease response after 24 and 36 months of ropeginterferon alfa-2b.
Slovenian: Odziv bolezni po 24 in 36 mesecih zdravljenja z ropeginterferonom alfa-2b Skupina, zdravljenja z ropeginterferonom alfa-2b
English: The 500 micrograms/0.5 mL pre-filled pen has a blue push button.
Slovenian: Napolnjen injekcijski peresnik s 500 mikrogrami/0,5 ml ima moder potisni gumb.
English: The 250 micrograms/0.5 mL pre-filled pen has a grey push button.
Slovenian: Napolnjen injekcijski peresnik z 250 mikrogrami/0,5 ml ima siv potisni gumb.
English: Patients who develop this condition during treatment and cannot be controlled by medicinal products should discontinue ropeginterferon alfa-2b therapy.
Slovenian: Bolniki, ki se jim med zdravljenjem pojavi sladkorna bolezen, ki je ni mogoče nadzorovati z zdravili, morajo zdravljenje z ropeginterferonom alfa-2b prekiniti.
English: Renal and urinary disorders uncommon cystitis haemorrhagic, dysuria, micturition urgency, urinary retention
Slovenian: Bolezni sečil občasni hemoragični cistitis, disurija, urgentna mikcija,
English: Besremi 250 mcg/0.5 mL injection ropeginterferon alfa-2b SC
Slovenian: Besremi 250 mcg/0,5 ml injekcija ropeginterferon alfa-2b s.c.
English: LIST OF EXCIPIENTS
Slovenian: NALEPKA PERESNIKA
English: Besremi 500 mcg/0.5 mL injection ropeginterferon alfa-2b SC
Slovenian: Besremi 500 mcg/0,5 ml injekcija ropeginterferon alfa-2b s.c.
English: The same elimination route is considered for ropeginterferon alfa-2b.
Slovenian: Menijo, da je pot izločanja ropeginterferona alfa-2b enaka.
English: 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#
Slovenian: akneiformni dermatitis, hiperkeratoza, hiperhidroza, suha koža občasni fotosenzitivna reakcija, deskvamacija kože, distrofija nohtov neznana depigmentacija kože#
English: - if you have or had an autoimmune disease (such as rheumatoid arthritis, psoriasis or inflammatory bowel disease).
Slovenian: - če imate ali ste imeli hude težave s srcem (kot je srčni infarkt ali kap); - če imate ali ste imeli avtoimuno bolezen (kot je revmatoidni artritis, luskavica ali vnetna črevesna bolezen);
English: 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
Slovenian: - 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,
English: Do not inject into skin that is irritated, reddened, bruised, infected or scarred in any way.
Slovenian: Nikakor ne injicirajte v kožo, ki je razdražena, pordela, podpluta, okužena ali brazgotinasta.
English: Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen 3 years.
Slovenian: Besremi 250 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku 3 leta
English: Each pre-filled pen contains 0.5 mL of solution.
Slovenian: En napolnjen injekcijski peresnik vsebuje 0,5 ml raztopine.
English: 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.
Slovenian: Ob sočasni uporabi z zdravili, ki se presnavljajo preko CYP2C9/19, CYP3A4 ali N-acetiltransferaze, prilagajanje odmerka ropeginterferona alfa-2b ni potrebno.
English: Name and address of the manufacturer(s) of the biological active substance(s) PharmaEssentia Corp.
Slovenian: Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (učinkovin)
English: The Besremi pre-filled pen comes with two needles.
Slovenian: Pakiranje napolnjenega injekcijskega peresnika zdravila Besremi vsebuje dve igli.
English: 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.
Slovenian: 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.
English: 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
Slovenian: Infekcijske in parazitske bolezni pogosti okužba zgornjih dihal, rinitis, glivična okužba kože občasni ustni herpes, herpes zoster, ustna kandidoza, sinuzitis,
English: PT
Slovenian: PI
English: The metabolism of ropeginterferon alfa-2b is not fully characterised.
Slovenian: Presnova ropeginterferona alfa-2b ni popolnoma opredeljena.
English: Coombs test positive, weight decreased #Reported as adverse reactions during treatment with other interferon alfa medicinal products.
Slovenian: #V poročilih kot neželeni učinki med zdravljenjem z drugimi zdravili z interferonom alfa.
English: 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
Slovenian: - izguba vida, ki jo lahko povzroči mrežnična krvavitev (mrežnica je na svetlobo občutljiv sloj v očesu) ali kopičenje maščobe pod ali v mrežnici.
English: Serious, acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) have been rarely observed with other interferon alfa medicinal products.
Slovenian: Pri bolnikih, zdravljenih z drugimi zdravili z interferonom alfa, so redko poročali o resnih, akutnih preobčutljivostnih reakcijah (npr. koprivnica, angioedem, bronhokonstrikcija, anafilaksija).
English: 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.
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Immune system disorders uncommon
Slovenian: Bolezni imunskega sistema občasni
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Ropeginterferon alfa-2b is contraindicated in patients with end stage renal disease (see section 4.3).
Slovenian: Ropeginterferon alfa-2b je kontraindiciran pri bolnikih s končno ledvično odpovedjo (glejte poglavje
English: Treatment with ropeginterferon alfa-2b should be discontinued when, despite dose reduction, the increase in liver enzyme levels is progressive and clinically significant.
Slovenian: Kadar je zvišanje jetrnih encimov napredujoče in klinično pomembno kljub zmanjšanju odmerka, je treba zdravljenje z ropeginterferonom alfa-2b prekiniti.
English: 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)
Slovenian: Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): - idiopatska ali trombotična trombocitopenična purpura (zvečano pojavljanje podplutb, krvavitev,
English: including suicidal ideation, attempted suicide, aggression, bipolar disorder, mania and confusion have been observed with other interferon alfa medicinal products.
Slovenian: Pri drugih zdravilih z interferonom alfa so opazili druge učinke na CŽS, vključno s samomorilnimi mislimi, poskusom samomora, agresijo, bipolarno motnjo, manijo in zmedenostjo.
English: Dose reduced
Slovenian: SPROŠČANJE SERIJ
English: Please read this leaflet carefully before using the Besremi 500 micrograms pre-filled pen.
Slovenian: Navodila za uporabo Pred uporabo zdravila Besremi 500 mikrogramov napolnjen injekcijski peresnik natančno preberite to navodilo.
English: Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b
Slovenian: Besremi 500 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku ropeginterferon alfa-2b
English: 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#,
Slovenian: zmanjšana ostrina vida, zamegljen vid, nelagodje v očesu, ekcem na vekah redki retinopatija#, nevropatija vidnega živca#, zapora mrežnične arterije#, zapora mrežnične vene#
English: Name and address of the manufacturer(s) responsible for batch release AOP Orphan Pharmaceuticals AG
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
English: Vascular disorders common microangiopathy uncommon
Slovenian: Žilne bolezni pogosti mikroangiopatija občasni
English: Description Besremi 500 micrograms pre-filled pen
Slovenian: Opis napolnjenega injekcijskega peresnika zdravila Besremi 500 mikrogramov
English: Ear and labyrinth disorders uncommon deafness, tinnitus, vertigo
Slovenian: vključno z motnjami labirinta občasni gluhost, tinitus, vrtoglavica
English: 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:
Slovenian: Splošne težave in spremembe na mestu aplikacije zelo pogosti gripi podobna bolezen, utrujenost pogosti pireksija, reakcija na mestu injiciranja, astenija, mrzlica,
English: Ropeginterferon alfa-2b treatment arm (n=127)
Slovenian: Značilnosti bolnikov ob presejanju v študiji PROUD-PV Skupina, zdravljenja z ropeginterferonom alfa-2b (n = 127)
English: Description Besremi 250 micrograms pre-filled pen
Slovenian: Opis napolnjenega injekcijskega peresnika zdravila Besremi 250 mikrogramov
English: Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b
Slovenian: Besremi 250 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku ropeginterferon alfa-2b
English: The recommended injection site is the abdominal skin around but not within 5 cm of the navel or the thigh.
Slovenian: 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.
English: Please read this leaflet carefully before using the Besremi 250 micrograms pre-filled pen.
Slovenian: Navodila za uporabo Pred uporabo zdravila Besremi 250 mikrogramov napolnjen injekcijski peresnik natančno preberite to navodilo.
English: Liver enzymes and hepatic function should be regularly controlled in patients with longterm ropeginterferon alfa-2b therapy.
Slovenian: Pri bolnikih na dolgotrajnem zdravljenju z ropeginterferonom alfa-2b je treba redno spremljati jetrne encime in delovanje jeter.
English: Ask your doctor or pharmacist for advice: - if you are pregnant or breast-feeding.
Slovenian: Zdravnika ali farmacevta vprašajte za nasvet:
English: Increased liver enzyme levels have been observed in patients treated with ropeginterferon alfa-2b.
Slovenian: Pri bolnikih, ki so jih zdravili z ropeginterferonom alfa-2b, so opazili zvišane ravni jetrnih encimov.
English: 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.
Slovenian: V programu kliničnega razvoja ropeginterferona alfa-2b je prišlo do 2 primerov resne depresije (1,1
English: Liver disorders have been reported in patients after long-term ropeginterferon alfa-2b therapy (see section 4.8).
Slovenian: Po dolgotrajnem zdravljenju z ropeginterferonom alfa-2b so pri bolnikih poročali o boleznih jeter (glejte poglavje 4.8).
English: 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.
Slovenian: 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.
English: Patients who develop symptoms indicative of a thyroid dysfunction during ropeginterferon alfa-2b therapy, should evaluate their thyroid stimulating hormone (TSH) levels.
Slovenian: Bolnikom, ki se jim med zdravljenjem z ropeginterferonom alfa-2b pojavijo simptomi, ki kažejo na okvaro delovanja ščitnice,
English: Enzymes of the protein catabolism are considered to be involved in the metabolism of ropeginterferon alfa-2b.
Slovenian: V presnovo ropeginterferona alfa-2b so domnevno vpleteni encimi, ki opravljajo razgradnjo beljakovin.
English: OTHER
Slovenian: onihomikoza
English: Water for injections
Slovenian: Shranjevanje zdravila Besremi
English: 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.
Slovenian: En napolnjen injekcijski peresnik z 0,5 ml raztopine vsebuje 250 mikrogramov ropeginterferona alfa-2b, merjeno glede na beljakovine, kar ustreza 500 mikrogramom/ml.
English: 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).
Slovenian: (pegilirani interferon alfa-2a in pegilirani interferon alfa-2b) (glejte poglavje 5.2).
English: 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
Slovenian: - zmanjšanje števila vrste belih krvnih celic (imenovanih levkociti) in celic, ki pomagajo pri strjevanju krvi (imenovanih trombociti), - bolečina v sklepih in mišicah,
English: A reduced starting dose for ropeginterferon alfa-2b of 50 micrograms is recommended for patients with severe (GFR 1529 mL/min) renal impairment.
Slovenian: 29 ml/min) je priporočljivo zmanjšanje začetnega odmerka ropeginterferona alfa-2b na 50 mikrogramov.
English: Other CNS effects,
Slovenian: - suhe oči,
English: 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
Slovenian: - bipolarna motnja (spremembe razpoloženja z epizodami žalosti in navdušenja), manija (ekstremno navdušenje ali nerazumljiv entuziazem),
English: Clear, colourless to pale yellow solution.
Slovenian: raztopina za injiciranje v napolnjenem injekcijskem peresniku (injekcija) Bistra, brezbarvna do bledo rumena raztopina.
English: The pharmacokinetic profile of ropeginterferon alfa-2b has not been determined in obese and underweighted patients.
Slovenian: Pri prekomerno prehranjenih ali podhranjenih bolnikih farmakokinetičnega profila ropeginterferona alfa-2b niso ovrednotili.
English: No n (%)
Slovenian: Izboljšanje n (%)
English: • Remove the cap from the pen.
Slovenian: • S peresnika odstranite pokrovček.
English: If you use more Besremi than you should
Slovenian: Če ste uporabili večji odmerek zdravila Besremi, kot bi smeli Čim prej obvestite zdravnika.
English: 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.
Slovenian: Pri drugem zdravilu z interferonom alfa (pegiliran interferon alfa-2a) so pri bolnikih s cirozo (Child
English: Studies in rats with a similar interferon alfa medicinal product (pegylated interferon alfa-2a) showed a primarily elimination via hepatic metabolism.
Slovenian: (pegiliran interferon alfa-2a) so pokazale primarno izločanje s presnovo v jetrih.
English: This overview was last updated in 02-2019.
Slovenian: Pregled je bil nazadnje posodobljen 02-2019.
English: It is used to treat the following diseases:
Slovenian: Uporablja se za zdravljenje naslednjih bolezni:
English: Further information on Simponi can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/simponi.
Slovenian: Nadaljnje informacije o zdravilu Simponi so na voljo na spletni strani agencije: ema.europa.eu/en/medicines/human/EPAR/simponi.
English: It can be used alone or in combination with methotrexate;
Slovenian: Lahko se uporablja samostojno ali v kombinaciji z metotreksatom;
English: This was assessed after 6 weeks in the first study and after 54 weeks in the second study.
Slovenian: To je bilo v prvi študiji ocenjeno po šestih tednih, v drugi pa po 54 tednih.
English: What measures are being taken to ensure the safe and effective use of Simponi?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Simponi?
English: Simponi received a marketing authorisation valid throughout the EU on 1 October 2009.
Slovenian: Za zdravilo Simponi je bilo 1. oktobra 2009 izdano dovoljenje za promet, veljavno po vsej EU.
English: 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.
Slovenian: 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.