FrancophonIA/ELRC3.0 huggingface dataset:
English: In children, the most common side effects with Eurartesim (seen in more than 1 patient in 10) were influenza (flu), cough and fever.
Slovenian: Najpogostejši neželeni učinki zdravila Eurartesim pri otrocih (opaženi pri več kot 1 od 10 bolnikov) so influenca (gripa), kašelj in povišana telesna temperatura.
English: In the first study, 63 days after treatment 97% of patients who received Eurartesim had been cured, compared with 95% of patients treated with the comparator medicine.
Slovenian: V prvi študiji je bilo po 63 dneh zdravljenja z zdravilom Eurartesim ozdravljenih 97 % bolnikov v primerjavi s 95 %bolnikov, ki so jih zdravili s primerjalnim zdravilom.
English: The main measure of effectiveness was the proportion of patients who were cured 28 days after treatment.
Slovenian: Glavno merilo učinkovitosti je bil odstotek bolnikov, ki so bili po 28 dneh zdravljenja ozdravljeni.
English: Eurartesim is used to treat uncomplicated malaria caused by the Plasmodium falciparum parasite.
Slovenian: Zdravilo Eurartesim se uporablja za zdravljenje nezapletene malarije, ki jo povzroča parazit Plasmodium falciparum.
English: In the second study, 28 days after treatment 93% of patients who received Eurartesim had been cured, compared with 95% of patients treated with the comparator medicine.
Slovenian: V drugi študiji je bilo po 28 dneh zdravljenja z zdravilom Eurartesim ozdravljenih 93 % bolnikov v primerjavi s 95 % bolnikov, ki so jih zdravili s primerjalnim zdravilom.
English: The CHMP considered that Eurartesim had been shown to be effective in treating uncomplicated P. falciparum malaria while the side effects were similar to those seen with comparable treatments.
Slovenian: CHMP je menil, da je zdravilo Eurartesim dokazano učinkovito pri zdravljenju nezapletene malarije P. falciparum, njegovi neželeni učinki pa so podobni tistim, ki so jih opazili pri primerljivih zdravilih.
English: Piperaquine tetraphosphate is a so-called bisquinolone.
Slovenian: Piperakin tetrafosfat je t. i. biskinolon.
English: What is the risk associated with Eurartesim?
Slovenian: Kakšna tveganja so povezana z zdravilom Eurartesim?
English: In the second study, Eurartesim was compared with another medicine containing artemether and lumefantrine in 1,553 children.
Slovenian: V drugi študiji so zdravilo Eurartesim pri 1 553 otrocih primerjali z drugim zdravilom proti malariji, ki vsebuje artemeter in lumefantrin.
English: Eurartesim is a malaria medicine that contains the active substances piperaquine tetraphosphate and artenimol.
Slovenian: Eurartesim je zdravilo, ki vsebuje zdravilni učinkovini piperakin tetrafosfat in artenimol.
English: Eurartesim was investigated in two main studies in patients with uncomplicated P. falciparum malaria.
Slovenian: Zdravilo Eurartesim so raziskovali v dveh glavnih študijah pri bolnikih z nezapleteno malarijo, ki jo je povzročila okužba s P. falciparum.
English: For the full list of all side effects with Eurartesim, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Eurartesim, glejte navodilo za uporabo.
English: Eurartesim was shown to be effective in treating uncomplicated P. falciparum malaria.
Slovenian: Dokazano je bilo, da je zdravilo Eurartesim učinkovito pri zdravljenju nezapletene malarije P. falciparum.
English: In the first study, Eurartesim was compared with another malaria medicine containing artesunate and mefloquine in 1,150 patients.
Slovenian: V prvi študiji so pri 1 150 bolnikih primerjali zdravilo Eurartesim z drugim zdravilom proti malariji, ki vsebuje artezunat in meflokin.
English: Why has Eurartesim been approved?
Slovenian: Zakaj je bilo zdravilo Eurartesim odobreno?
English: How has Eurartesim been studied?
Slovenian: Kako je bilo zdravilo Eurartesim raziskano?
English: What is Eurartesim used for?
Slovenian: Za kaj se zdravilo Eurartesim uporablja?
English: What is Eurartesim?
Slovenian: Kaj je zdravilo Eurartesim?
English: How does Eurartesim work?
Slovenian: Kako zdravilo Eurartesim deluje?
English: It is thought to work by blocking a step in the parasite's metabolism needed for its survival.
Slovenian: Domnevajo, da zavira postopek v presnovi parazita,
English: How is Eurartesim used?
Slovenian: Kako se zdravilo Eurartesim uporablja?
English: They may also have episodes of depression.
Slovenian: Imajo lahko tudi epizode depresije.
English: Its exact mechanism of action is unknown, but it attaches to several different receptors on nerve cells in the brain.
Slovenian: Natančen mehanizem njegovega delovanja ni znan, znano pa je, da se veže na več različnih receptorjev na živčnih celicah v možganih.
English: In this way, aripiprazole helps to change the activity of the nerve cells which are thought to give rise to psychotic or manic symptoms and preventing them from returning.
Slovenian: Na ta način aripiprazol pomaga spremeniti delovanje živčnih celic, ki naj bi povzročale psihotične ali manične simptome, in preprečuje njihovo ponovitev.
English: This means that it is similar to a ‘reference medicine', but it contains aripiprazole at a new strength in addition to existing strengths: while the reference medicine, Abilify, is available as 5, 10, 15 and 30 mg, Aripiprazole Sandoz is also available as 20 mg tablets.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, vendar poleg obstoječih jakosti vključuje novo jakost aripiprazola: referenčno zdravilo Abilify je na voljo v jakostih 5, 10, 15 in 30 mg, zdravilo Aripiprazole Sandoz pa tudi kot 20 mg tablete.
English: The full EPAR and risk management plan summary for Aripiprazole Sandoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Aripiprazole Sandoz sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This disrupts signals transmitted between brain nerve cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Slovenian: S tem je moten prenos signalov med živčnimi celicami v možganih prek „nevrotransmitorjev“ (živčnih prenašalcev), tj. kemičnih snovi, ki omogočajo sporazumevanje med celicami.
English: This is a summary of the European public assessment report (EPAR) for Aripiprazole Sandoz.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Aripiprazole Sandoz.
English: The dose should be adjusted in patients who are taking other medicines that affect the way Aripiprazole Sandoz is broken down in the body.
Slovenian: Odmerek je treba prilagoditi pri bolnikih, ki jemljejo druga zdravila, ki vplivajo na razgradnjo zdravila Aripiprazole Sandoz v telesu.
English: The Committee recommended that Aripiprazole Sandoz be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Aripiprazole Sandoz odobri za uporabo v EU.
English: Aripiprazole Sandoz aripiprazole
Slovenian: Aripiprazole Sandoz aripiprazol
English: Because Aripiprazole Sandoz is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Aripiprazole Sandoz biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: This means that aripiprazole acts like dopamine and 5-hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters.
Slovenian: To pomeni, da aripiprazol z aktiviranjem teh receptorjev deluje kot dopamin in 5-hidroksitriptamin, vendar šibkeje kot nevrotransmitorji.
English: Aripiprazole is thought to act mainly by being a ‘partial agonist' at the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin).
Slovenian: Aripiprazol domnevno deluje predvsem kot „delni agonist“ receptorjev za nevrotransmitorja dopamin in 5-hidroksitriptamin (imenovan tudi serotonin).
English: What measures are being taken to ensure the safe and effective use of Aripiprazole Sandoz?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Aripiprazole Sandoz?
English: Aripiprazole Sandoz is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults whose illness has improved with the medicine in the past.
Slovenian: Zdravilo Aripiprazole Sandoz se uporablja pri odraslih za zdravljenje zmernih do hudih maničnih epizod ter preprečevanje novih maničnih epizod pri odraslih, katerih bolezen se je v preteklosti z zdravilom že izboljšala.
English: The company provided data from the published literature on aripiprazole.
Slovenian: Družba je predstavila podatke o aripiprazolu iz objavljene literature.
English: Aripiprazole Sandoz is used in patients with the following mental illnesses:
Slovenian: Zdravilo Aripiprazole Sandoz se uporablja pri bolnikih z naslednjimi duševnimi boleznimi:
English: What are the benefits and risks of Aripiprazole Sandoz?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Aripiprazole Sandoz?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Sandoz has been shown to have comparable quality and to be bioequivalent to Abilify.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Aripiprazole Sandoz primerljivo raven kakovosti kot zdravilo Abilify ter da mu je biološko enakovredno.
English: A risk management plan has been developed to ensure that Aripiprazole Sandoz is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Aripiprazole Sandoz je bil pripravljen načrt obvladovanja tveganj.
English: For more information about treatment with Aripiprazole Sandoz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Aripiprazole Sandoz preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: In addition, when used for patients aged 13 years or older with moderate to severe manic episodes in bipolar I disorder, the company that markets Aripiprazole Sandoz will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in these patients.
Slovenian: Poleg tega bo družba, ki trži zdravilo Aripiprazole Sandoz, za bolnike, stare 13 let ali več, z zmernimi do hudimi maničnimi epizodami pri bipolarni motnji I pripravila izobraževalno gradivo za bolnike, njihove negovalce in zdravnike, ki bo pojasnjevalo varno uporabo tega zdravila pri teh bolnikih.
English: For practical information about using Aripiprazole Sandoz, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Aripiprazole Sandoz naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Sandoz, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Aripiprazole Sandoz contains the active substance aripiprazole and is a ‘generic' and a ‘hybrid' medicine.
Slovenian: Zdravilo Aripiprazole Sandoz vsebuje zdravilno učinkovino aripiprazol in je „generično“ in „hibridno“ zdravilo.
English: Aripiprazole Sandoz is used in patients aged 15 years or over;
Slovenian: Zdravilo Aripiprazole Sandoz se uporablja pri bolnikih, starih 15 let ali več;
English: Other information about Aripiprazole Sandoz
Slovenian: Druge informacije o zdravilu Aripiprazole Sandoz
English: For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg by mouth once a day, either on its own or in combination with other medicines.
Slovenian: Za zdravljenje maničnih epizod pri bipolarni motnji pri odraslih je priporočeni začetni odmerek 15 mg peroralno enkrat na dan, ki se jemlje samostojno ali v kombinaciji z drugimi zdravili.
English: Aripiprazole Sandoz is available as tablets and can only be obtained with a prescription.
Slovenian: Zdravilo Aripiprazole Sandoz je na voljo v obliki tablet in se izdaja le na recept.
English: The active substance in Aripiprazole Sandoz, aripiprazole, is an antipsychotic medicine.
Slovenian: Zdravilna učinkovina v zdravilu Aripiprazole Sandoz, aripiprazol, je antipsihotik.
English: The company carried out ‘bioequivalence' studies to show that Aripiprazole Sandoz is bioequivalent to the reference medicine, Abilify.
Slovenian: Družba je izvedla študije biološke enakovrednosti, s katerimi je pokazala, da je zdravilo Aripiprazole Sandoz biološko enakovredno referenčnemu zdravilu Abilify.
English: What is Aripiprazole Sandoz and what is it used for?
Slovenian: Kaj je zdravilo Aripiprazole Sandoz in za kaj se uporablja?
English: Aripiprazole Sandoz is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.
Slovenian: Zdravilo Aripiprazole Sandoz se uporablja tudi za zdravljenje zmernih do hudih maničnih epizod pri bolnikih, starih 13 let ali več, v obdobju do 12 tednov.
English: Why is Aripiprazole Sandoz approved?
Slovenian: Zakaj je bilo zdravilo Aripiprazole Sandoz odobreno?
English: How has Aripiprazole Sandoz been studied?
Slovenian: Kako je bilo zdravilo Aripiprazole Sandoz raziskano?
English: How is Aripiprazole Sandoz used?
Slovenian: Kako se zdravilo Aripiprazole Sandoz uporablja?
English: How does Aripiprazole Sandoz work?
Slovenian: Kako zdravilo Aripiprazole Sandoz deluje?
English: It is not intended to provide practical advice on how to use Aripiprazole Sandoz.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Then carry on as normal, sticking to your usual injection day.
Slovenian: Nato pa nadaljujte kot normalno z injiciranjem na vaš običajni dan.
English: Clicking Clicking Stops
Slovenian: Klikanje Klikanje preneha
English: No risk factors or alternative aetiology have been reported in any of these cases.
Slovenian: V nobenem od teh primerov niso poročali o dejavnikih tveganja ali alternativni etiologiji.
English: • Very rare (<1/10,000) • Not known (cannot be estimated from the available data)
Slovenian: • neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)
English: Chronic administration of daclizumab beta at all doses increased the incidence of skin findings (compared to those observed in control animals).
Slovenian: Kronično dajanje daklizumaba beta pri vseh odmerkih je povečalo incidenco izsledkov na koži (v primerjavi z opaženimi pri kontrolnih živalih).
English: Four new serious cases of colitis confirmed by health-care professionals have been received during this period.
Slovenian: V tem obdobju so poročali o štirih novih resnih primerih kolitisa, ki so jih potrdili zdravstveni delavci.
English: Daclizumab beta pharmacokinetics are well described by a two-compartment model with first-order absorption and elimination.
Slovenian: Farmakokinetika daklizumaba beta je dobro opisana v dvoprostornem modelu z absorpcijo in izločanjem prvega reda.
English: • The liquid is cloudy or contains floating
Slovenian: • je tekočina motna ali vsebuje plavajoče
English: In vitro investigative studies suggest that microglial aggregates are not due to a direct effect of daclizumab beta on microglial cells but are likely to be attributable to an increase in local IL-2 bioavailability.
Slovenian: Raziskovalne študije in vitro kažejo, da agregati celic mikroglije ne nastajajo kot neposredni učinek daklizumaba beta na mikroglijske celice, temveč so verjetno posledica povečanja biološke uporabnosti lokalnega IL-2.
English: Daclizumab beta was detected in the milk of 11/14 lactating monkeys at levels that were <0.122% of the maternal serum levels, with no adverse reactions observed in the off-spring.
Slovenian: Daklizumab beta so odkrili v mleku 11/14 opic v laktaciji v ravneh, ki so bile < 0,122 % ravni v serumu matere, brez neželenih učinkov pri potomcih.
English: Choose an injection site and wipe the skin
Slovenian: Izberite mesto injiciranja in kožo obrišite z
English: Daclizumab beta had no effect on peri- and post-natal development from birth to up to 6 months in the offspring.
Slovenian: Daklizumab beta nima vpliva na perinatalni in postnatalni razvoj potomcev od rojstva do 6 mesecev starosti.
English: Available toxicology data in lactating cynomolgus monkeys have shown excretion of daclizumab beta in milk (for details see section 5.3).
Slovenian: Razpoložljivi toksikološki podatki pri doječih opicah cynomolgus kažejo na izločanje daklizumaba beta v mleko (za podrobnosti glejte poglavje 5.3).
English: Based on the cross-study population pharmacokinetic analysis, daclizumab beta pharmacokinetics were not influenced by age (range: 18 to 66 years; n=1670) or gender (n = 567 males and 1103 females).
Slovenian: Na podlagi medštudijske analize populacijske farmakokinetike na farmakokinetiko daklizumaba beta nista vplivala starost (razpon: 18 do 66 let; n = 1670) ali spol (n = 567 moških in 1103 žensk).
English: Do not inject into an area of the body
Slovenian: Ne injicirajte v predel telesa, kjer je
English: • The need to screen for hepatitis B and C prior to treatment initiation and to recommend patients who test positive for HBV or HCV infection to consult with a physician with expertise in the
Slovenian: • potrebi presejanja za hepatitis B in C pred začetkom zdravljenja in o potrebi, da se bolniki, ki imajo pozitiven test na okužbo s HBV ali HCV, posvetujejo z zdravnikom, izkušenim v
English: • If you do forget a dose, and it is within 2 weeks of your missed dose, inject as soon as you can.
Slovenian: • Če izpustite odmerek in sta od pozabljenega odmerka minila manj kot 2 tedna, si ga injicirajte takoj, ko lahko.
English: There was limited exposure in patients over 55 years of age in clinical studies with daclizumab beta.
Slovenian: Izpostavljenost bolnikov, starih več kot 55 let, v kliničnih študijah z daklizumabom beta je bila omejena.
English: • The recommendation not to initiate treatment in patients with autoimmune disorders (other than
Slovenian: • priporočilu, naj se zdravljenje ne uvaja pri bolnikih z avtoimunskimi boleznimi (razen multiple
English: This small volume of distribution indicates that daclizumab beta is primarily confined to the vascular and interstitial spaces.
Slovenian: Ta majhen volumen porazdelitve kaže, da je daklizumab beta primarno omejen na ožilje in intersticijski prostor.
English: Section 4.8 of the SmPC has been reviewed to add the adverse reaction sarcoidosis with a frequency uncommon and the adverse reaction colitis with a frequency common.
Slovenian: Poglavje 4.8 SmPC-ja je bilo revidirano z dodatkom neželenega učinka sarkoidoza s pogostnostjo občasni in neželenega učinka kolitis s pogostnostjo pogosti.
English: In the DECIDE study (see section 5.1), patients were tested for anti-drug (daclizumab beta) antibodies at week 4 and approximately every 3 months thereafter.
Slovenian: V študiji DECIDE (glejte poglavje 5.1) so pri bolnikih testirali prisotnost protiteles proti zdravilu (daklizumab beta) v 4. tednu, nato pa približno vsake 3 mesece.
English: What Zinbryta is and what it is used for What you need to know before you use Zinbryta
Slovenian: Kaj je zdravilo Zinbryta in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Zinbryta
English: Do not use the pen if it has been dropped or is visibly damaged.
Slovenian: Napolnjenega injekcijskega peresnika ne uporabljajte, če pade ali je vidno poškodovan.
English: Do not share the pen with anyone else to avoid giving an infection to them or getting an
Slovenian: Napolnjenega injekcijskega peresnika ne delite z nikomer, da ne bi od koga dobili infekcije ali da ne bi kdo dobil infekcije od vas.
English: Following subcutaneous administration of daclizumab beta, the median time to reach maximum serum concentrations (Tmax) ranged from 5 to 7 days.
Slovenian: Po subkutanem dajanju daklizumaba beta je bil razpon mediane časa za doseganje največje koncentracije v serumu (tmax) od 5 do 7 dni.
English: The absolute bioavailability of daclizumab beta 150 mg subcutaneously administered was approximately 90% based on a cross-study population pharmacokinetic analysis of subcutaneous and intravenous dosing.
Slovenian: Absolutna biološka uporabnost daklizumaba beta 150 mg, apliciranega subkutano, je bila približno 90 % na podlagi medštudijske analize populacijske farmakokinetike subkutanega in intravenskega odmerjanja.
English: Consistent with results from individual studies, a cross-study population pharmacokinetic analysis indicated that daclizumab beta exposure is more than dose-proportional in the 50 mg to 100 mg subcutaneous dose range and is dose proportional in the 100 mg to 300 mg subcutaneous dose range.
Slovenian: V skladu z rezultati posamičnih študij je medštudijska analiza populacijske farmakokinetike pokazala, da je izpostavljenost daklizumabu beta več kot sorazmerna z odmerkom pri subkutanem odmerku 50 mg do 100 mg, in da je sorazmerna z odmerkom v razponu subkutanega odmerka 100 mg do 300 mg.
English: Quickly insert the needle straight into the skin fold until the needle is fully
Slovenian: Iglo hitro vbodite naravnost v kožno gubo tako, da je igla povsem pod kožo.
English: These findings (dry, red raised patchy areas of the skin, as compared to controls, that correlated microscopically with acanthosis/hyperkeratosis and subacute to chronic inflammation) were characterised predominantly as mild to moderate, with one case assessed as severe.
Slovenian: Ti izsledki (suhe, rdeče izbočene kožne zaplate, v primerjavi s kontrolo, kar mikroskopsko korelira z akantozo/hiperkeratozo in subakutnim do kroničnim vnetjem) so bili opisani pretežno kot blagi do zmerni, en primer pa je bil ocenjen kot resen.
English: Daclizumab beta is a humanised IgG1 monoclonal antibody that binds to CD25 (IL-2Rα), and prevents IL-2 binding to CD25.
Slovenian: Daklizumab beta je humanizirano monoklonsko protitelo IgG1, ki se veže na CD25 (IL-2Rα) in prepreči vezavo IL-2 na CD25.
English: Daclizumab beta did not affect reproductive capacity in female and male cynomolgus monkeys (AUC in females and males up to 85 and 100 times higher than the exposure at the clinical dose respectively).
Slovenian: Daklizumab beta ni vplival na sposobnost razmnoževanja pri samicah in samcih opic vrste cynomolgus (AUC pri samicah in samcih do 85- oz. 100-krat večji, kot je izpostavljenost pri kliničnih odmerkih).
English: • Immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis)
Slovenian: • imunska bolezen, ki lahko prizadene pljuča, kožo in bezgavke (sarkoidoza)
English: • If you see blood at your injection site, wipe it off with the gauze pad and apply an
Slovenian: • Če na mestu injiciranja vidite kri, jo obrišite z gazo in namestite lepljiv povoj ali
English: Preclinical safety studies were conducted in cynomolgus monkeys due to species specificity of daclizumab beta binding only to human or primate CD25.
Slovenian: Predklinične študije so izvedli na opicah vrste cynomolgus zaradi specifičnosti vrste pri vezavi daklizumaba beta samo na CD25 pri ljudeh ali primatih.
English: On the basis of the scientific conclusions for daclizumab beta the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing daclizumab beta is unchanged subject to the proposed changes to the product information
Slovenian: Na podlagi znanstvenih zaključkov za daklizumab beta odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) daklizumab beta, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: You b. c.
Slovenian: Videti b. c.