FrancophonIA/ELRC3.0 huggingface dataset:
English: Mozobil may cause dizziness and fatigue.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Mozobil lahko povzroči omotico in utrujenost.
English: Study
Slovenian: Dojenje
English: How to store Mozobil
Slovenian: Shranjevanje zdravila Mozobil
English: Regimen
Slovenian: Shema
English: Further information on Veyvondi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Veyvondi so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The main measure of effectiveness was based on an assessment of how well the treatment worked.
Slovenian: Glavno merilo učinkovitosti je temeljilo na oceni učinkovitosti delovanja zdravila.
English: The dose and frequency of treatment depend on the type and seriousness of the bleeding episode or extent of the surgery, and the patient's condition and body weight.
Slovenian: Odmerek in pogostnost dajanja zdravila sta odvisna od vrste in resnosti epizode krvavenja ali obsega kirurškega posega ter bolnikovega stanja in telesne mase.
English: The European Medicines Agency decided that Veyvondi's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Veyvondi večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Treatment with Veyvondi was successful in 95% of patients (20 out of 22).
Slovenian: Zdravljenje z zdravilom Veyvondi je bilo uspešno pri 95 % (20 od 22) bolnikov.
English: What measures are being taken to ensure the safe and effective use of Veyvondi?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Veyvondi?
English: Veyvondi (vonicog alfa)
Slovenian: Veyvondi (vonikog alfa)
English: It replaces the missing protein, thereby helping the blood to clot and giving temporary control of the bleeding disorder.
Slovenian: Nadomešča manjkajočo beljakovino ter tako pripomore k strjevanju krvi in omogoči začasen nadzor nad motnjo strjevanja krvi.
English: As for all medicines, data on the use of Veyvondi are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Veyvondi stalno spremljajo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Veyvondi have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Veyvondi upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: The most common side effects with Veyvondi (which may affect up to 1 in 10 patients) are dizziness, vertigo (a spinning sensation), dysgeusia (taste disturbances), tremor, rapid heartbeat, deep venous thrombosis (blood clot in a deep vein, usually in the leg), hypertension (high blood pressure), hot flush, vomiting, nausea (feeling sick), pruritus (itching), chest discomfort, sensations like numbness, tingling, pins and needles at the site of infusion, and an abnormal reading on the electrocardiogram (ECG).
Slovenian: Najpogostejši neželeni učinki zdravila Veyvondi (ki se lahko pojavijo pri največ 1 bolniku od 10) so omotica, vrtoglavica (občutek vrtenja), disgevzija (motnje okusa), tresenje, hiter srčni utrip, globoka venska tromboza (krvni strdek v globoki veni, običajno v nogi), hipertenzija (visok krvni tlak), vročinski oblivi, bruhanje, navzeja (slabost), pruritus (srbenje), nelagodje v prsnem košu, občutki, kot so odrevenelost, mravljinčenje in zbadanje na mestu infundiranja, ter nenormalen odčitek na elektrokardiogramu (EKG).
English: Other information about Veyvondi
Slovenian: Druge informacije o zdravilu Veyvondi
English: Why is Veyvondi authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Veyvondi odobreno v EU?
English: Side effects reported with Veyvondi are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Veyvondi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: A total of 193 bleeding episodes were recorded, and Veyvondi was rated ‘excellent' or ‘good' at treating around 98% of bleedings.
Slovenian: Skupno je bilo zabeleženih 193 epizod krvavenja, zdravilo Veyvondi pa je bilo ocenjeno kot odlično ali dobro pri zdravljenju približno 98 % krvavitev.
English: For more information about using Veyvondi, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Veyvondi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What benefits of Veyvondi have been shown in studies?
Slovenian: Kakšne koristi zdravila Veyvondi so se pokazale v študijah?
English: Patients with von Willebrand disease lack von Willebrand factor, a protein needed for normal clotting of the blood, and as a result, they bleed readily.
Slovenian: Bolnikom z von Willebrandovo boleznijo primanjkuje von Willebrandov faktor, tj. beljakovina, potrebna za normalno strjevanje krvi, zato hitro zakrvavijo.
English: However EMA decided that, as for similar medicines, Veyvondi should be used only when desmopressin (the main treatment for von Willebrand disease) cannot be used or is not working well enough.
Slovenian: Agencija je zaključila, da naj bi se zdravilo Veyvondi, tako kot velja za podobna zdravila, uporabljalo samo, kadar dezmopresina (glavnega zdravila za zdravljenje von Willebrandove bolezni) ni mogoče uporabiti ali pa ne deluje dovolj dobro.
English: The active substance in Veyvondi, vonicog alfa, works in the body in the same way as natural von Willebrand factor.
Slovenian: Učinkovina v zdravilu Veyvondi, vonikog alfa, deluje v telesu enako kot naravni von Willebrandov faktor.
English: An overview of Veyvondi and why it is authorised in the EU
Slovenian: Pregled zdravila Veyvondi in zakaj je odobreno v EU
English: Veyvondi must not be used in patients who have had allergic reactions to mouse or hamster proteins.
Slovenian: Zdravilo Veyvondi se ne sme uporabljati pri bolnikih, pri katerih se je pojavila alergijska reakcija na beljakovine miši ali hrčka.
English: What are the risks associated with Veyvondi?
Slovenian: Kakšna tveganja so povezana z zdravilom Veyvondi?
English: The first study involved 37 patients who were given Veyvondi for the treatment of bleeding episodes.
Slovenian: Prva študija je vključevala 37 bolnikov, ki so zdravilo Veyvondi prejemali za zdravljenje epizod krvavenja.
English: The benefits of Veyvondi in controlling bleeding have been shown in two main studies involving 52 patients with von Willebrand disease.
Slovenian: Koristi zdravila Veyvondi pri nadzoru krvavenja so bile dokazane v dveh glavnih študijah z 52 bolniki z von Willebrandovo boleznijo.
English: The second study involved 15 patients who were given Veyvondi to prevent bleeding during surgery, including major surgery such as knee replacement.
Slovenian: V drugo študijo je bilo vključenih 15 bolnikov, ki so prejemali zdravilo Veyvondi za preprečevanje krvavitev med kirurškim posegom, vključno z obsežnimi poškodbami, na primer zamenjavo kolena.
English: What is Veyvondi and what is it used for?
Slovenian: Kaj je zdravilo Veyvondi in za kaj se uporablja?
English: The side effects with Veyvondi were considered typical for this type of medicine.
Slovenian: Neželeni učinki zdravila Veyvondi so bili ocenjeni kot značilni za to vrsto zdravila.
English: Veyvondi is a medicine used to control bleeding in patients with von Willebrand disease (an inherited bleeding disorder), who cannot be treated with another medicine called desmopressin or when desmopressin is ineffective.
Slovenian: Veyvondi je zdravilo, ki se uporablja za nadzor krvavenja pri bolnikih z von Willebrandovo boleznijo (dedno motnjo krvavenja), ki jih ni mogoče zdraviti z drugim zdravilom, imenovanim dezmopresin, ali kadar je dezmopresin neučinkovit.
English: In the 15 major and minor surgeries that occurred during the study, Veyvondi was rated as excellent or good at preventing bleeding episodes for all 15 surgeries.
Slovenian: Pri 15 velikih in malih kirurških posegih, ki so bili opravljeni med študijo, je bilo zdravilo Veyvondi pri vseh 15 kirurških posegih ocenjeno kot odlično ali dobro pri preprečevanju epizod krvavitve.
English: It is used ‘on demand' to treat bleeding episodes and is also used to prevent and treat bleeding during surgery.
Slovenian: Uporablja se na zahtevo za zdravljenje epizod krvavenja ter za preprečevanje in zdravljenje krvavenja med kirurškimi posegi.
English: Veyvondi is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Slovenian: Zdravilo Veyvondi je na voljo v obliki praška in vehikla, ki se zmešata v raztopino za injiciranje v veno.
English: Veyvondi was shown to be effective in treating bleeding episodes in patients with von Willebrand disease.
Slovenian: Zdravilo Veyvondi se je pokazalo kot učinkovito za zdravljenje epizod krvavenja pri bolnikih z von Willebrandovo boleznijo.
English: Veyvondi contains the active substance vonicog alfa.
Slovenian: Zdravilo Veyvondi vsebuje učinkovino vonikog alfa.
English: The following side effects may occur during treatment with Veyvondi: hypersensitivity (allergic) reactions, thromboembolic events (problems due to the formation of blood clots in the blood vessels), development of inhibitors (antibodies) against von Willebrand factor, causing the medicine to stop working and resulting in a loss of bleeding control.
Slovenian: Pri zdravljenju z zdravilom Veyvondi se lahko pojavijo naslednji neželeni učinki: preobčutljivostne (alergijske) reakcije, tromembolični dogodki (težave zaradi nastajanja krvnih strdkov v krvnih žilah), nastanek zaviralcev (protiteles) proti von Willebrandovi bolezni, ki povzročijo prenehanje delovanja zdravila in izgubo nadzora nad krvavenjem.
English: For the full list of side effects of Veyvondi, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov zdravila Veyvondi glejte navodilo za uporabo.
English: Veyvondi was also effective for preventing and treating bleeding related to surgery.
Slovenian: Prav tako je bilo učinkovito pri preprečevanju in zdravljenju krvavitev, povezanih s kirurškimi posegi.
English: Veyvondi can only be obtained with a prescription and treatment should be supervised by a doctor experienced in treating patients with bleeding disorders.
Slovenian: Predpisovanje in izdaja zdravila Veyvondi je le na recept, zdravljenje pa mora uvesti zdravnik z izkušnjami z zdravljenjem motenj strjevanja krvi.
English: How is Veyvondi used?
Slovenian: Kako se zdravilo Veyvondi uporablja?
English: How does Veyvondi work?
Slovenian: Kako zdravilo Veyvondi deluje?
English: Date of first authorisation: 21 May 2007 Date of latest renewal: 21 May 2012
Slovenian: Datum prve odobritve: 21. maj 2007 Datum zadnjega podaljšanja: 21. maj 2012
English: Slight bleeding is normal.
Slovenian: Rahla krvavitev je normalna.
English: Some of these infections have been fatal.
Slovenian: Nekatere od teh okužb so bile usodne.
English: Long-term extension period
Slovenian: Dolgoročno podaljšano obdobje
English: Health-related outcomes and quality of life
Slovenian: Z zdravstvenim stanjem povezani izidi in kvaliteta življenja
English: Improve your physical function and your ability to do normal daily activities.
Slovenian: izboljšanje telesne zmogljivosti in zmožnosti za opravljanje vsakdanjih aktivnosti.
English: The relevance of these results to humans is unknown.
Slovenian: Pomen teh rezultatov za ljudi ni znan.
English: OTHER SPECIAL WARNING(S), IF NECESSARY 8.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA 8.
English: • Show this card to any doctor involved in your treatment.
Slovenian: • To kartico pokažite vsakemu zdravniku, ki sodeluje pri vašem zdravljenju.
English: After that you will receive a dose every 4 weeks.
Slovenian: Odmerek zdravila boste nato prejemali vsake 4 tedne.
English: Abatacept is the first selective co-stimulation modulator.
Slovenian: Abatacept je prvi selektivni modulator kostimulacije.
English: Safety and structural damage assessments were conducted at one and two years.
Slovenian: Varnost in strukturne poškodbe so ovrednotili po enem in dveh letih.
English: Important instructions for use.
Slovenian: Pomembna navodila za uporabo.
English: Period Cb (day 1765)
Slovenian: obdobje Cb (1765. dan)
English: E. Wash your hands thoroughly with soap and warm water.
Slovenian: E. Temeljito si umijte roke z milom in toplo vodo.
English: RA is usually a chronic (long-term), progressive disease.
Slovenian: RA je običajno kronična (dolgotrajna) in napredujoča bolezen.
English: It is very important that you tell your doctor if you have ever had TB, or if you have been in close contact with someone who has had TB.
Slovenian: Zelo pomembno je, da zdravnika obvestite, če ste kdaj imeli tuberkulozo ali če ste bili v tesnem stiku z osebo, ki je imela tuberkulozo.
English: This is normal and will not affect your dose.
Slovenian: To je običajen pojav in ne vpliva na odmerek.
English: Important instructions for use Please read these instructions carefully and follow them step by step.
Slovenian: Pomembna navodila za uporabo Navodila natančno preberite in jim sledite korak za korakom.
English: Rheumatoid arthritis (RA) affects everyone differently.
Slovenian: Revmatoidni artritis (RA) prizadene vsakega bolnika drugače.
English: BEFORE YOU BEGIN:
Slovenian: PREDEN ZAČNETE:
English: End of Period Ba (day 169)
Slovenian: konec obdobja Ba (169. dan)
English: If you have active psoriatic arthritis you will first be given other medicines.
Slovenian: Če imate aktivni psoriazni artritis, se boste najprej zdravili z drugimi zdravili.
English: PsA-IIb,c
Slovenian: Študija PsA-IIb,c
English: There are no adequate data from use of abatacept in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi abatacepta pri nosečnicah.
English: Proportion of patients with a clinically meaningful improvementd
Slovenian: Odstotek bolnikov s klinično pomembnim izboljšanjemd
English: Reductions in serum TNFα were also observed.
Slovenian: Opaženo je bilo tudi zmanjšanje serumskega TNFα.
English: Disease activity was also assessed using the Disease Activity Score 28.
Slovenian: Aktivnost bolezni so vrednotili tudi na osnovi ocene aktivnosti bolezni 28 (Disease Activity Score 28).
English: Study SC-I
Slovenian: Študija SC-I
English: c Health Assessment Questionnaire; 0 = best, 3 = worst; 20 questions; 8 categories: dressing and grooming, arising, eating,
Slovenian: c Vprašalnik za oceno zdravstvenega stanja; 0 = boljše, 3 = slabše; 20 vprašanj; 8 kategorij: oblačenje in nega, vstajanje,
English: Read carefully.
Slovenian: Natančno preberite.
English: The final concentration of abatacept in the bag or bottle will depend upon the amount of active substance added, but will be no more than 10 mg/mL.
Slovenian: Končna koncentracija abatacepta v vrečki ali steklenici je odvisna od količine dodane učinkovine, vendar pa ne sme biti večja od 10 mg/ml.
English: Combination with other medicinal products that affect the immune system and with vaccinations
Slovenian: Kombinacija z drugimi zdravili, ki vplivajo na imunski sistem in s cepljenji
English: The clinical significance of this observation is unknown (see section 5.3).
Slovenian: Klinični pomen teh ugotovitev ni znan (glejte poglavje 5.3).
English: The type of pre-filled syringe you receive depends on the dose prescribed by your doctor.
Slovenian: Vrsta napolnjene injekcijske brizge, ki jo boste prejeli, je odvisna od odmerka, ki vam ga je predpisal zdravnik.
English: No systemic hypersensitivity reactions were reported.
Slovenian: O sistemskih preobčutljivostnih reakcijah niso poročali.
English: 30 Minutes
Slovenian: 30 minut
English: D. Gather your additional supplies and keep them within easy reach.
Slovenian: D. Pripravite dodatne potrebščine in jih imejte na dosegu roke.
English: After 1 year of treatment, the maintenance of remission was assessed by the relapse of the disease.
Slovenian: Po 1 letu zdravljenja je bilo vzdrževanje remisije ovrednoteno glede na povrnitev bolezni.
English: In most people, joint symptoms develop gradually over several years.
Slovenian: Pri večini bolnikov se simptomi prizadetosti sklepov razvijajo postopoma več let.
English: This is equivalent to 1.7% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To je enako 1,7 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: Of the 219 patients treated, 205 completed the short-term period and 200 entered the ongoing longterm extension period.
Slovenian: Od 219 zdravljenih bolnikov je 205 zaključilo kratkoročno obdobje, 200 pa jih je nato bilo vključenih v dolgoročno podaljšano obdobje, ki še poteka.
English: BEFORE YOU BEGIN
Slovenian: PREDEN ZAČNETE
English: Remission rates at end of drug treatment and drug withdrawal phases in study SC-III
Slovenian: Deleži remisije na koncu zdravljenja z zdravilom in faze odtegnitve zdravila v študiji SC-III
English: Most of these reactions were mild to moderate.
Slovenian: Večina teh neželenih učinkov je bila blagih do zmernih.
English: The occurrence of anaphylaxis remained rare during the double blind and the cumulative period.
Slovenian: Pojavnost anafilaksije je med dvojno slepim in kumulativnim obdobjem ostala redka.
English: Studies in adult mice and monkeys have not demonstrated similar findings.
Slovenian: Pri študijah pri odraslih miših in opicah o takih ugotovitvah ne poročajo.
English: DAS28 response
Slovenian: DAS28 odziv
English: * No active joints, physician's global assessment of disease severity ≤10 mm and CRP ≤0.6 mg/dL.
Slovenian: * Brez aktivnih sklepov, zdravnikova globalna ocena resnosti bolezni ≤ 10 mm in CRP ≤ 0,6 mg/dl.
English: Similar efficacy was observed in these patients and in younger patients.
Slovenian: Pri teh bolnikih je bila učinkovitost podobna kot pri mlajših bolnikih.
English: The exposure adjusted incidence rate (expressed per 100 person-years) remained stable over the treatment duration.
Slovenian: Na izpostavljenost prilagojeni delež pojavnosti (izražen na 100 oseblet) je s trajanjem zdravljenja ostal stabilen.
English: The ACRP responses and inactive disease results were maintained through 2 years.
Slovenian: Rezultati v obliki ACRP odziva in neaktivnosti bolezni so se v 2-letnem obdobju ohranili.
English: Study IV did not require any specific number of tender or swollen joints.
Slovenian: Študija IV ni zahtevala specifičnega števila občutljivih ali oteklih sklepov.
English: Avoid prolonged or vigorous agitation.
Slovenian: Izogibajte se dolgotrajnemu ali močnemu tresenju.
English: Consequently, these infants may be at increased risk of infection.
Slovenian: Pri teh dojenčkih se posledično lahko poveča tveganje za okužbo.
English: The significance of the higher incidence in the 2 to 5 year age cohort is unknown, taking into account the difference in sample size.
Slovenian: Pomen večje pojavnosti v kohorti bolnikov, starih od 2 do 5 let, ni znan, upoštevajoč razliko v velikosti vzorca.
English: Abatacept Abatacept Placebo Abatacept group in Period B
Slovenian: abatacept abatacept placebo skupina z abataceptom v obdobju B
English: Lonza Biologics Inc. 101 International Drive Portsmouth, NH 03801-2815 USA
Slovenian: Lonza Biologics Inc. 101 International Drive Portsmouth, NH 03801-2815 ZDA
English: The relevance of these findings to the clinical use of abatacept is unknown.
Slovenian: Pomen teh ugotovitev za klinično uporabo abatacepta ni znan.
English: Reduce the signs and symptoms of your disease.
Slovenian: zmanjšanje znakov in simptomov bolezni,
English: HOW TO USE
Slovenian: KAKO UPORABLJATI
English: Formal studies of the potential effect of abatacept on human fertility have not been conducted.
Slovenian: Formalne študije o možnih učinkih abatacepta na plodnost pri človeku niso bile izvedene.
English: Inadequate response to MTX
Slovenian: Nezadosten odziv na MTX
English: c Major clinical response is defined as achieving an ACR 70 response for a continuous 6-month period.
Slovenian: c Večji klinični odziv je definiran kot dosežen odziv ACR 70, ki je trajal neprekinjeno 6 mesecev.
English: WAIT until blue indicator stops moving
Slovenian: POČAKAJTE dokler se moder kazalec
English: Long-term safety data in 2 to 5 year age cohort with pJIA was limited, but the existing evidence did not reveal any new safety concern in this younger paediatric population.
Slovenian: Podatkov o dolgoročni varnosti v kohorti bolnikov s pJIA, starih od 2 do 5 let, je malo, vendar pa obstoječi dokazi ne kažejo na nobene nove varnostne zadržke pri tej mlajši pediatrični populaciji.
English: Non-responder in Period A
Slovenian: bolniki brez odziva v obdobju A
English: Immunogenicity and safety of abatacept upon withdrawal and restart of treatment
Slovenian: Imunogenost in varnost abatacepta po prekinitvi in ponovni uvedbi zdravljenja
English: How to use ORENCIA 4.
Slovenian: Kako uporabljati zdravilo ORENCIA 4.
English: Confirm: after a complete injection, the needle guard will cover the needle and you may hear a click.
Slovenian: Potrditev: po popolnem injiciranju bo varovalo za iglo prekrilo iglo, pri tem pa lahko zaslišite klik.
English: N/A Proportion of randomised patients in remission at 12 months and at 18 months (6 months of complete drug withdrawal)
Slovenian: N/A Delež randomiziranih bolnikov v remisiji v 12. mesecu in v 18. mesecu (6 mesecev popolne odtegnitve zdravila)
English: The types of infections were consistent with those commonly seen in outpatient paediatric populations.
Slovenian: Vrste okužb so bile konsistentne s tistimi, pogosto opaženimi pri ambulantno zdravljenih pediatričnih populacijah.
English: Samples with confirmed binding activity to CTLA-4 were assessed for the presence of neutralizing antibodies.
Slovenian: Vzorci s potrjenim vezalnim delovanjem za CTLA-4 so bili ovrednoteni na prisotnost nevtralizirajočih protiteles.
English: The respective values for ACR 50 and ACR 70 at 12 months and 24 months were consistent and similar for abatacept and adalimumab.
Slovenian: Ustrezne vrednosti ACR 50 in ACR 70 so bile po 12 mesecih in 24 mesecih konsistentne in podobne za abatacept in adalimumab.
English: The systemic clearance was approximately 0.22 mL/h/kg.
Slovenian: Sistemski očistek je bil približno 0,22 ml/h/kg.
English: Complete ALL steps to deliver your full dose of the medicine
Slovenian: Dokončajte VSE korake, da aplicirate celoten odmerek zdravila.
English: Patients continued abatacept treatment in an ongoing open-label extension, which assessed long-term safety and efficacy for an additional 20 months.
Slovenian: Bolniki nadaljujejo zdravljenje z abataceptom v odprtem podaljšku študije, ki še poteka, z njim pa bodo ovrednotili dolgoročno varnost in učinkovitost za še dodatnih 20 mesecev.
English: - Any unused portion in the vials must be immediately discarded in accordance with local requirements.
Slovenian: - Neporabljeno vsebino vial morate nemudoma zavreči v skladu z lokalnimi predpisi.
English: Studies in rats exposed to abatacept have shown immune system abnormalities including a low incidence of infections leading to death (juvenile rats).
Slovenian: Študije pri podganah, ki so bile izpostavljene abataceptu, so pokazale nepravilnosti imunskega sistema, vključno z manjšo incidenco okužb, ki so povzročile pogine (mladiči podgan).
English: Mean radiographic changes over 12 months in study II
Slovenian: Srednje vrednosti radiografskih sprememb med 12 meseci v študiji II
English: Treatment with immunosuppressive therapy, such as ORENCIA, may be associated with progressive multifocal leukoencephalopathy (PML).
Slovenian: Zdravljenje z imunosupresivnimi zdravili, kot je zdravilo ORENCIA, je lahko povezano s progresivno multifokalno levkoencefalopatijo (PML).
English: Non-clinical studies relevant for use in the paediatric population
Slovenian: Predklinične študije, relevantne za uporabo zdravila pri pediatrični populaciji