natgillin/translations-raw huggingface dataset:
In order to address the uncertainties with regards to the efficacy and safety of Symbioflor 2 (Escherichia coli bacteria (cells and autolysate)) and associated names in the treatment of irritable bowel syndrome in adult patients, the MAH should conduct and submit the results of a well-designed and adequately powered multicentre double blind randomised placebo controlled post approval efficacy study allowing for relevant subpopulation analyses, in accordance with an agreed protocol to assess the efficacy of Symbioflor 2 in the treatment of IBS in general versus subtypes of the disease such as IBS C and IBS D, both gender, disease severity and address the sustainability of efficacy The final study report should be submitted to the relevant National Competent Authorities.
Za preučitev negotovosti v zvezi z učinkovitostjo in varnostjo zdravila Symbioflor 2 (bakterije Escherichia coli (celice in avtolizat)) in povezanih imen pri zdravljenju sindroma razdražljivega črevesa pri odraslih bolnikih mora imetnik dovoljenja za promet z zdravilom opraviti (in nato predložiti njene rezultate) dobro zasnovano multicentrično, dvojno slepo, randomizirano, s placebom nadzorovano študijo učinkovitosti po odobritvi z zadostno statistično močjo, ki bo omogočila primerne analize podpopulacij, v skladu z dogovorjenim protokolom za oceno učinkovitosti zdravila Symbioflor 2 pri zdravljenju sindroma razdražljivega črevesa na splošno v primerjavi s podtipi bolezni, kot so sindrom razdražljivega črevesa C in D, oba spola, resnost bolezni, ter za preučitev trajnosti učinkovitosti.
Submission of the final study results by March
Predložitev končnih rezultatov študije do marca 2022.
Symbioflor 2 (Escherichia coli bacteria (cells and autolysate)) and associated names
Symbioflor 2 (bakterije Escherichia coli (celice in avtolizat)) in povezana imena
Annex IV Conditions to the marketing authorisation(s)
Priloga IV Pogoji dovoljenja (dovoljenj) za promet z zdravilom
Conditions to the marketing authorisation(s)
Pogoji dovoljenja (dovoljenj) za promet z zdravilom
15 January 2015 EMA/35715/2015
15. januar 2015 EMA/35715/2015
Contact our press officer Monika Benstetter
Stopite v stik z našim tiskovnim predstavnikom Monika Benstetter
Healthcare professionals should follow these recommendations:
Zdravstveni delavci morajo upoštevati naslednja priporočila:
• If you have any questions or concerns, you should consult your doctor or another healthcare professional.
• Če imate kakršna koli vprašanja ali pomisleke, se posvetujte s svojim zdravnikom ali drugim zdravstvenim delavcem.
Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
Tel. +44 (0)20 3660 8427 E-pošta: press@ema.europa.eu
Available at: http://www.nejm.org/doi/full/10.1056/NEJMoa1406430 (accessed 14/11/14).
Na voljo na spletni strani: http://www.nejm.org/doi/full/10.1056/NEJMoa1406430 (dostop 14.11.14).
Your doctor will regularly measure your heart rate particularly before starting treatment and when adjusting the dose.
Vaš zdravnik bo redno meril vaš srčni utrip, zlasti pred začetkom zdravljenja in ob prilagajanju odmerka.
The review of Procoralan/Corlentor was initiated on 8 May 2014 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Pregled zdravila Procoralan/Corlentor se je pričel 8. maja 2014 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
• Healthcare professionals have been informed in writing of these new recommendations, and the product information for Corlentor/Procoralan has been updated accordingly.
• Zdravstveni delavci so bili pisno obveščeni o teh novih priporočilih, informacije o zdravilu Corlentor/Procoralan pa so bile ustrezno posodobljene.
In addition, discontinuation should be considered if the improvement is only limited and if there is no clinically relevant reduction in resting heart rate within 3 months.
Poleg tega je treba razmisliti o ukinitvi zdravljenja, če je izboljšanje le omejeno in če v 3 mesecih ni opaziti klinično pomembnega znižanja srčnega utripa v mirovanju.
Regular monitoring for the occurrence of atrial fibrillation is recommended.
Priporočljivo je redno spremljanje z namenom zaznave atrijske fibrilacije.
The review of Corlentor/Procoralan was first carried out by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC).
Pregled zdravila Corlentor/Procoralan je najprej opravil Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC) pri agenciji.
It works by lowering the heart rate thereby reducing the stress on the heart and slowing the progression of heart failure and reducing or preventing the symptoms of angina.
Deluje tako, da znižuje srčni utrip ter tako zmanjšuje obremenitev srca, upočasnjuje napredovanje srčnega popuščanja in zmanjšuje ali preprečuje simptome angine pektoris.
Corlentor/Procoralan received an EU-wide marketing authorisation on 25 October 2005.
Za zdravilo Corlentor/Procoralan je bilo dovoljenje za promet, veljavno po vsej EU, izdano 25. oktobra 2005.
Corlentor and Procoralan are identical medicines that contain the active substance ivabradine.
Zdravili Corlentor in Procoralan sta enaki zdravili, ki vsebujeta zdravilno učinkovino ivabradin.
If atrial fibrillation develops during treatment, the balance of benefits and risks of continued Corlentor/Procoralan treatment should be carefully reconsidered.
Če se med zdravljenjem razvije atrijska fibrilacija, je treba skrbno pretehtati razmerje med koristmi in tveganji nadaljevanja zdravljenja z zdravilom Corlentor/Procoralan.
Its use is only beneficial for symptomatic treatment in patients with chronic stable angina pectoris who cannot be treated with beta-blockers, or in combination with beta-blockers in case their disease is not controlled with them alone.
Njegova uporaba je koristna le za simptomatsko zdravljenje bolnikov s kronično stabilno angino pektoris, ki je ni mogoče zdraviti z zaviralci receptorjev beta, ali v kombinaciji z zaviralci receptorjev beta, kadar ti ne zadoščajo za obvladovanje bolezni.
The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Opravil ga je Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC), pristojni odbor za ocenjevanje vprašanj glede varnosti zdravil za uporabo v humani medicini, ki je nato oblikoval niz priporočil.
On 20 November 2014, the European Medicines Agency (EMA) completed a review of Corlentor/Procoralan (ivabradine) and made recommendations aimed at reducing the risk of heart problems, including heart attack and bradycardia (excessively low heart rate), in patients taking the medicine for angina.
20. novembra 2014 je Evropska agencija za zdravila (EMA) zaključila pregled zdravila Corlentor/Procoralan (ivabradin) in podala priporočila za zmanjšanje tveganja za težave s srcem, vključno s srčnim infarktom in bradikardijo (prenizkim srčnim utripom), pri bolnikih, ki jemljejo to zdravilo za zdravljenje angine pektoris.
• If during treatment the heart rate decreases below 50 bpm at rest or the patient experiences symptoms related to bradycardia, the dose must be decreased (the lowest dose is 2.5 mg twice daily).
• Če se med zdravljenjem srčni utrip zniža pod 50 utripov na minuto v mirovanju ali če ima bolnik simptome, povezane z bradikardijo, je treba odmerek zmanjšati (najmanjši odmerek je 2,5 mg dvakrat dnevno).
Because of a small but significant increase of the combined risk of cardiovascular death, myocardial infarction and heart failure seen in patients with symptomatic angina in the SIGNIFY study, recommendations have been issued to reduce this risk.
Zaradi majhnega, vendar značilnega povečanja kombiniranega tveganja za kardiovaskularno smrt, miokardni infarkt in srčno popuščanje, opaženega pri bolnikih s simptomatsko angino pektoris v študiji SIGNIFY, so bila oblikovana priporočila za zmanjšanje tega tveganja.
• Prior to starting treatment or when considering titration, serial heart rate measurements, ECG, or ambulatory 24-hour monitoring should be considered when determining the heart rate.
• Pred začetkom zdravljenja ali ob morebitnem titriranju je treba pri določanju srčnega utripa razmisliti o možnosti zaporednih meritev srčnega utripa, EKG ali ambulantnega 24-urnega spremljanja.
• The benefit-risk balance of Corlentor/Procoralan remains positive for its authorised indications.
• Razmerje med koristmi in tveganji pri zdravilu Corlentor/Procoralan ostaja pozitivno za odobrene indikacije.
The PRAC recommendations have been endorsed by the Agency's Committee for Medicinal Products for Human Use (CHMP).
Priporočila odbora PRAC je podprl Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji.
The PRAC recommendations were then sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
Priporočila odbora PRAC so bila zatem posredovana Odboru za zdravila za uporabo v humani medicini (CHMP), pristojnemu odboru za vprašanja glede zdravil za uporabo v humani medicini, ki je sprejel končno mnenje agencije.
• Corlentor/Procoralan must not be used together with the medicines verapamil or diltiazem which reduce the heart rate.
• Zdravilo Corlentor/Procoralan se ne sme uporabljati skupaj z zdraviloma verapamil ali diltiazem, ki znižujeta srčni utrip.
Corlentor/Procoralan is available as tablets.
Zdravilo Corlentor/Procoralan je na voljo v obliki tablet.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom was observed in 5.3% of patients taking Corlentor/Procoralan compared with 3.8% in the placebo group.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom pri bolnikih, zdravljenih z zdravilom Corlentor/Procoralan, v primerjavi s kontrolno skupino (4,9 % proti 4,1 %).
• As Corlentor/Procoralan could cause irregular rapid contractions of the upper chambers of the heart (a condition known as atrial fibrillation) your doctor will monitor your heart function regularly and will reconsider treatment if atrial fibrillation develops.
• Ker bi zdravilo Corlentor/Procoralan lahko povzročilo nepravilno, hitro krčenje preddvorov srca (ta motnja se imenuje atrijska fibrilacija), bo vaš zdravnik redno spremljal delovanje vašega srca in v primeru pojava atrijske fibrilacije ponovno pretehtal zdravljenje.
If, despite dose reduction, the heart rate remains below 50 bpm or symptoms of bradycardia persist, treatment must be discontinued.
Če se srčni utrip kljub zmanjšanju odmerka ne poviša na najmanj 50 utripov na minuto ali simptomi bradikardije ne izzvenijo, je treba prenehati z zdravljenjem.
Because patients treated with Corlentor/Procoralan for angina symptoms may be at increased risk of heart problems such as heart attack, recommendations have been issued to reduce this risk and ensure that the benefits continue to outweigh the risks.
Ker utegne pri bolnikih, ki uporabljajo zdravilo Corlentor/Procoralan za lajšanje simptomov angine pektoris, obstajati povečano tveganje za težave s srcem, kot je srčni infarkt, so bila oblikovana priporočila, da bi to tveganje zmanjšali in zagotovili, da koristi jemanja zdravila ostajajo večje od zadevnih tveganj.
• The data from SIGNIFY did not demonstrate a beneficial effect for Corlentor/Procoralan on cardiovascular outcomes in coronary artery patients without clinical heart failure.
• Podatki iz študije SIGNIFY ne kažejo, da bi imelo zdravilo Corlentor/Procoralan koristen učinek na kardiovaskularne izide pri bolnikih s koronarno arterijsko boleznijo brez kliničnega srčnega popuščanja.
Doctors should consider stopping treatment if there is no improvement in angina symptoms after 3 months, or if the improvement is only limited.
Zdravniki bi morali razmisliti o ukinitvi zdravljenja, če v 3 mesecih ni opaziti izboljšanja simptomov angine pektoris ali če je to izboljšanje le omejeno.
• Corlentor/Procoralan should be discontinued if the symptoms of angina do not improve within 3 months.
• Zdravljenje z zdravilom Corlentor/Procoralan je treba ukiniti, če se simptomi angine pektoris v 3 mesecih ne izboljšajo.
The data also indicated a higher risk of bradycardia with Corlentor/Procoralan compared with placebo (17.9% vs.
Podatki poleg tega kažejo na večje tveganje za bradikardijo ob uporabi zdravila Corlentor/Procoralan v primerjavi s placebom (17,9 % proti 2,1 %).
• Your doctor will stop treatment with Corlentor/Procoralan if your symptoms of angina (such as shortness of breath) do not improve within 3 months or if the improvement is only limited.
• Zdravnik bo ukinil zdravljenje z zdravilom Corlentor/Procoralan, če se vaši simptomi angine pektoris (kot je zasoplost) v 3 mesecih ne izboljšajo ali če je izboljšanje le omejeno.
• Your doctor will start treatment with Corlentor/Procoralan at a dose of up to 5 mg twice daily and increase it if necessary to a maximum of 7.5 mg twice daily.
• Zdravnik vam bo na začetku zdravljenja z zdravilom Corlentor/Procoralan predpisal odmerek do 5 mg dvakrat dnevno in ga po potrebi povečal na največ 7,5 mg dvakrat dnevno.
• The concomitant use of Corlentor/Procoralan with verapamil or diltiazem is now contraindicated.
• Sočasna uporaba zdravila Corlentor/Procoralan z zdravilom verapamil ali diltiazem je sedaj kontraindicirana.
Other recommendations are that doctors must not prescribe Corlentor/Procoralan together with the medicines verapamil or diltiazem that reduce the heart rate, and that they should monitor their patients for atrial fibrillation (irregular rapid contractions of the upper chambers of the heart).
V priporočilih je navedeno tudi, da zdravniki ne smejo predpisovati zdravila Corlentor/Procoralan skupaj z zdraviloma verapamil ali diltiazem, ki znižujeta srčni utrip, ter da bi morali preverjati, ali se je pri bolnikih morebiti pojavila atrijska fibrilacija (nepravilno, hitro krčenje preddvorov srca).
Corlentor/Procoralan is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body).
Zdravilo Corlentor/Procoralan se uporablja tudi pri bolnikih s kroničnim srčnim popuščanjem (kadar srce ni zmožno prečrpati dovolj krvi v druge dele telesa).
Because Corlentor/Procoralan has not been shown to provide benefits such as reducing the risk of heart attack or cardiovascular death (death due to heart problems), the medicine should only be used to alleviate symptoms of angina.
Ker se zdravilo Corlentor/Procoralan ni izkazalo za učinkovito pri zmanjševanju tveganja za srčni infarkt ali kardiovaskularno smrt (smrt zaradi težav s srcem), se lahko uporablja le za lajšanje simptomov angine pektoris.
Patients in the SIGNIFY study were started on a higher than recommended dose of Corlentor/Procoralan and received up to 10 mg twice a day, which is higher than the currently authorised maximum daily dose (7.5 mg twice a day).
Začetni odmerek zdravila Corlentor/Procoralan pri bolnikih v študiji SIGNIFY je bil večji od priporočenega, saj so ti prejemali do 10 mg dvakratno dnevno, kar presega trenutno odobren največji dnevni odmerek (7,5 mg dvakrat dnevno).
• The starting dose of Corlentor/Procoralan should not exceed 5 mg twice daily and the maintenance dose of Corlentor/Procoralan should not exceed 7.5 mg twice daily.
• Začetni odmerek zdravila Corlentor/Procoralan ne sme presegati 5 mg dvakrat dnevno, vzdrževalni odmerek pa ne sme presegati 7,5 mg dvakrat dnevno.
Corlentor/Procoralan is used to treat symptoms of long-term stable angina (chest pain due to problems with the blood flow to the heart) in adults with coronary heart disease (disease of the heart caused by the obstruction of the blood vessels that supply blood to the heart muscle) who have a normal heart rhythm.
Zdravilo Corlentor/Procoralan se uporablja za zdravljenje simptomov kronične stabilne angine pektoris (bolečine v prsnem košu zaradi težav z dotokom krvi v srce) pri odraslih s koronarno srčno boleznijo (boleznijo srca, ki jo povzroča zapora krvnih žil, ki dovajajo kri v srčno mišico), ki imajo normalen srčni utrip.
These recommendations are based on the EMA's review of the final data from the SIGNIFY study1, which showed that in a subgroup of patients who had symptomatic angina there was a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with Corlentor/Procoralan compared with placebo (3.4% vs 2.9% yearly incidence rates).
V študiji so pri podskupini bolnikov s simptomatsko angino pektoris zabeležili majhno, vendar značilno povečanje kombiniranega tveganja za kardiovaskularno smrt ali nesmrten srčni infarkt ob uporabi zdravila Corlentor/Procoralan v primerjavi s placebom (letna stopnja pojavnosti je znašala 3,4% proti 2,9 %).
• In the symptomatic treatment of patients with chronic stable angina, Corlentor/Procoralan should only be started if the patient's resting heart rate is above or equal to 70 beats per minute (bpm).
• Za simptomatsko zdravljenje bolnikov s kronično stabilno angino pektoris se zdravljenje z zdravilom Corlentor/Procoralan lahko uvede le, če bolnikov srčni utrip v mirovanju znaša vsaj 70 utripov na minuto.
• Your doctor will only start Corlentor/Procoralan if your resting heart rate is at least 70 beats per minute (bpm).
• Vaš zdravnik bo zdravljenje z zdravilom Corlentor/Procoralan uvedel le, če vaš srčni utrip v mirovanju znaša vsaj 70 utripov na minuto.
However, the Agency reiterated that the starting dose for angina should not exceed 5 mg twice a day and that the maximum dose should not exceed 7.5 mg twice a day.
EMA je menila, da večji odmerek, uporabljen v študiji, ne pojasnjuje v celoti ugotovitev, kljub temu pa je ponovno opozorila, da začetni odmerek za angino pektoris ne sme presegati 5 mg dvakrat dnevno in da največji odmerek ne sme presegati 7,5 mg dvakrat dnevno.
• The risk of developing atrial fibrillation is increased in patients treated with Corlentor/Procoralan.
• Pri bolnikih, ki se zdravijo z zdravilom Corlentor/Procoralan, je tveganje za razvoj atrijske fibrilacije povečano.
When used for angina, Corlentor/Procoralan should only be started if the patient's resting heart rate is at least 70 beats per minute (bpm).
Pri angini pektoris se zdravljenje z zdravilom Corlentor/Procoralan lahko uvede le, če bolnikov srčni utrip v mirovanju znaša vsaj 70 utripov na minuto.
• Corlentor/Procoralan is a medicine used to treat symptoms of angina (chest pain due to problems with the blood flow to the heart) and to treat heart failure.
• Zdravilo Corlentor/Procoralan se uporablja za zdravljenje simptomov angine pektoris (bolečine v prsnem košu zaradi težav z dotokom krvi v srce) in za zdravljenje srčnega popuščanja.
Corlentor/Procoralan is used to treat symptoms of angina (chest pain due to problems with the blood flow to the heart) and to treat heart failure.
Zdravilo Corlentor/Procoralan se uporablja za zdravljenje simptomov angine pektoris (bolečine v prsnem košu zaradi težav z dotokom krvi v srce) in za zdravljenje srčnega popuščanja.
In its evaluation the EMA also assessed additional data on the safety and effectiveness of Corlentor/Procoralan which showed that the risk of atrial fibrillation is increased in patients treated with Corlentor/Procoralan compared with controls (4.9% vs 4.1%).
Evropska agencija za zdravila je v okviru svojega ocenjevanja pregledala tudi dodatne podatke o varnosti in učinkovitosti zdravila Corlentor/Procoralan, ki izkazujejo večje tveganje za atrijsko fibrilacijo
SE = standard error.
SE = standardna napaka.
Some of these patients have been under 50 years of age.
Nekateri od teh bolnikov so bili mlajši od 50 let.
Key results of studies 2, 3 and 4 are shown below.
Ključni rezultati študij 2, 3 in 4 so prikazani spodaj.
This is due to air pressure and should not be of concern.
Do tega pride zaradi zračnega pritiska, to naj vas ne skrbi.
• Wash your hands thoroughly.
Temeljito si umijte roke.
(It may be helpful to keep notes on the location of the previous injections.)
(Morda vam bo v pomoč, če si boste beležili mesta predhodnih injekcij.)
Serious allergic reactions are rare.
Resne alergijske reakcije so redke.
Immediate use is then recommended.
Nato priporočamo takojšnjo uporabo.
Date of first authorisation: 13 February 2017 Date of last renewal: {DD month YYYY}
Datum prve odobritve: 13. februar 2017 Datum zadnjega podaljšanja: {DD. mesec LLLL}
Wait until all the powder dissolves (usually less than 10 minutes).
Počakajte, da se ves prašek raztopi (običajno v manj kot 10 minutah).
From a microbiological point of view, the reconstituted medicinal product should be used immediately.
Z mikrobiološkega stališča je treba rekonstituirano zdravilo uporabiti takoj.
This benefit was maintained in Year 2 of this study.
To koristno delovanje se je ohranjalo tudi v drugem letu te študije.
c: Remission is defined as DAS <1.6.
c: Remisija je definirana kot DAS < 1,6.
Frequency Not Known (Cannot be Estimated from Available Data)
Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)
The half-life is long, approximately 70 hours.
Njegova razpolovna doba je dolga in znaša približno 70 ur.
Very Rare
Zelo redki
Long-term studies to assess the safety of the combination are ongoing.
Dolgoročne študije za oceno varnosti te kombinacije zdravil še potekajo.
Wash your hands with soap and warm water.
Umijte si roke z milom in s toplo vodo.
Always have the outer carton of the medicine with you, even if it is empty.
Vedno vzemite s seboj škatlo zdravila, tudi če je prazna.
The powder is white.
Prašek je bele barve.
Paediatric population See Summary of the safety profile, above.
Pediatrična populacija Glejte Povzetek varnostnega profila zgoraj.
The healthcare professional's educational material should contain the following key elements:
Izobraževalno gradivo za zdravstvene delavce mora vsebovati naslednje ključne sestavine:
See section 4.4 for vaccination advice.
Glejte poglavje 4.4 za nasvete o cepljenju.
Gather the items that you will need for your injection, and place them on the chosen surface:
Zberite predmete, ki jih boste potrebovali za injekcijo, in jih položite na izbrano površino:
Clear or almost clear defined as 0 or 1 on a 0 to 5 scale.
"Čisto" ali "skoraj čisto" definirano kot 0 ali 1 na lestvici od 0 do 5.
• The risk of opportunistic infections and tuberculosis (TB)
• tveganje za oportunistične okužbe in tuberkulozo
On pressing the centre of the button, you will hear a click.
Ob pritisku sredine gumba boste slišali klik.
Do not warm in any other way.
Ne segrevajte na noben drug način.
Do not warm LIFMIOR in any other way (for example, do not warm it in a microwave or in hot water).
Zdravila LIFMIOR ne segrevajte na noben drug način (npr. ne segrevajte ga v mikrovalovni pečici ali topli vodi).
Check the expiry date (month/year) on the pen.
Preverite datum izteka roka uporabnosti (mesec/leto) na peresniku.
These are rare or uncommon side effects, but are serious conditions (some of which may rarely be fatal).
To so redki ali občasni neželeni učinki, ki pa so resni (nekateri od njih so v redkih primerih lahko smrtni).
b: Values for Disease Activity Score (DAS) are means.
b: Vrednosti za oceno aktivnosti bolezni (DAS - Disease Activity Score) so povprečne vrednosti.
Please read the instructions carefully and follow them step by step.
Navodilo skrbno preberite in sledite napotkom korak za korakom.
With continued therapy, responses were maintained up to 48 weeks.
Ob nadaljevanju zdravljenja so se odzivi ohranili do 48 tednov.
LIFMIOR N=103 to 105*
LIFMIOR n = 103 do 105*
Your doctor will help you to decide whether the benefits of treatment outweigh the potential risk to your baby.
Zdravnik vam bo pomagal pri odločitvi, ali so koristi zdravljenja večje od možnega tveganja za vašega dojenčka.
Do not be concerned, as you will remove the air in a later step.
To naj vas ne skrbi, ker ga boste kasneje odstranili.
D-88397 Biberach an der Riss
D-88397 Biberach an der Riss Nemčija
The safety profile was consistent with that observed in other JIA studies.
Varnostni profil je bil podoben kot v drugih študijah JIA.
These antibodies have all been non-neutralising and are generally transient.
Protitelesa niso bila nevtralizirajoča in so na splošno prehodna.
The 2 year data did not reveal any new safety findings.
Podatki, zbrani v 2 letih, niso pokazali novih dognanj o varnosti.