natgillin/translations-raw huggingface dataset:
It is unknown whether rilonacept is excreted in human or animal breast milk. 
Ni znano, ali se rilonacept izloča v ženskem ali živalskem mleku.
No study was conducted to evaluate the effect of age, gender, or body weight on rilonacept exposure. 
Opravljena ni bila nobena študija za vrednotenje učinka starosti, spola ali telesne mase na izpostavljenost rilonaceptu.
This medicinal product has been authorised under “Exceptional Circumstances”. 
Zdravilo je pridobilo dovoljenje za promet v “izjemnih okoliščinah”.
Physicians should monitor the lipid profiles of their patients (for example after 2-3 months) and consider lipid-lowering therapies as needed based upon cardiovascular risk factors and current guidelines. 
Zdravniki naj spremljajo lipidne profile svojih bolnikov (na primer po 2-3 mesecih) in po potrebi uvedejo zdravila za zniževanje ravni lipidov na podlagi dejavnikov srčno-žilnega tveganja in trenutno veljavnih smernic.
In patients with CAPS, the body produces excessive amounts of IL-1 beta. 
Pri bolnikih s CAPS telo izdeluje čezmerne količine IL-1 beta.
• Other medicines that block interleukin-1, such as anakinra or canakinumab. 
• druga zdravila, ki zavirajo interlevkin-1, kot je anakinra ali kanakinumab;
The following information is intended for medical or healthcare professionals only and is provided as a tear-off leaflet: 
Naslednje informacije so namenjene samo zdravstvenemu osebju in so na voljo kot brošura, ki se odtrga:
• The need to monitor patients for changes in their lipid profiles; 
• o potrebi, da spremljajo spremembe lipidnega profila bolnikov;
Check if the vial contains any particles or clumps of powder that have not dissolved. 
Preverite, ali viala vsebuje delce ali kepice praška, ki so niso raztopili.
Figure 13b (Small Children, Thin Patients) 
Slika 13b (majhni otroci, suhi bolniki) 6.
No patients withdrew from the study due to ISRs. 
Noben bolnik ni zaradi ISR izstopil iz študije.
The results for the adults who entered the study in Part A are provided separately from the results of the adults who entered directly into the open label extension; the results for the four adolescents who entered directly into the open label extension are provided individually. 
Rezultati za odrasle, ki so se vključili v del A študije, so prikazani ločeno od rezultatov odraslih, ki so se vključili neposredno v odprto podaljšanje; rezultati štirih mladostnikov, ki so se vključili v odprto podaljšanje, so prikazani individualno.
Each pack contains: 
Eno pakiranje vsebuje:
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted immediately. 
V primeru prevelikega odmerka priporočajo spremljanje bolnika glede kakršnih koli znakov ali simptomov neželenih reakcij in takojšnjo uvedbo ustreznega simptomatskega zdravljenja.
Genotoxicity or long term animal studies have not been performed to evaluate the mutagenic or carcinogenic potential of rilonacept. 
Študij genotoksičnosti ali dolgoročnih študij na živalih za ovrednotenje mutagenega ali kancerogenega potenciala rilonacepta niso opravili.
• Increased blood pressure 
• zvišan krvni tlak;
The data reflect the percentage of patients whose test results were positive for antibodies to rilonacept in specific assays, and are highly dependent on the sensitivity and specificity of the assays. 
Podatki zrcalijo odstotni delež bolnikov, katerih testni rezultati so bili pozitivni na protitelesa proti rilonaceptu pri specifičnih testih, in so močno odvisni od občutljivosti in specifičnosti testov.
The MAH is requested to provide regular safety and efficacy data from the Global Registry for both adults and children. 
Imetnik dovoljenja za promet z zdravilom mora posredovati redne podatke o varnosti in učinkovitosti iz globalnega registra tako za odrasle kot za otroke.
• if you have an active, severe infection. 
• če imate težko aktivno okužbo.
This means that it is injected through a short needle into the fatty tissue just under the skin. 
To pomeni, da se injicira skozi kratko iglo v maščobno tkivo tik pod kožo.
Used alcohol wipes can be thrown away in the household rubbish. 
Rabljene alkoholne zložence lahko zavržete z gospodinjskimi odpadki.
• one used for injection 
• ena se uporabi za injiciranje
Begin at the centre of the site and move outward. 
Začnite sredi mesta injiciranja in se pomikajte navzven.
*p< 0.0001, comparison of rilonacept vs. placebo **p< 0.001, comparison of rilonacept vs. placebo, NS = not significant 
*p< 0,0001, primerjava rilonacepta s placebom **p< 0,001, primerjava rilonacepta s placebom NS = nesignifikantno
There was no correlation of antibody activity and either clinical efficacy or safety. 
Korelacije med aktivnostjo protiteles in bodisi klinično učinkovitostjo bodisi varnostjo ni bilo.
However, clinical experience in patients above 65 years is limited, therefore caution is recommended (see section 5.1). 
Vendar so klinične izkušnje pri bolnikih, starejših od 65 let, omejene, zato priporočamo previdnost (glejte poglavje 5.1).
• The risk of acute injection-related reactions; 
• o tveganju akutnih reakcij, povezanih z okužbami;
Pharmacotherapeutic group: Interleukin inhibitors, ATC code: L04AC04. 
Farmakoterapevtska skupina: Zaviralci interlevkinov, oznaka ATC: L04AC04.
Each vial should be used for a single dose only. 
Vsaka viala se sme uporabiti samo za enkraten odmerek.
Do not touch this area again before injecting. 
Pred injiciranjem se tega predela ne dotikajte več.
Therefore, live vaccines should not be given concurrently with Rilonacept Regeneron, unless the benefits clearly outweigh the risks. 
Zato živih cepiv ne smemo dajati sočasno z zdravilom Rilonacept Regeneron, razen če koristi očitno odtehtajo nevarnosti.
Table 4: Key symptom scores by age and diagnosis following 24-week open label extension Group 
Preglednica 4: Izidi ključnih simptomov po starosti in diagnozi po 24-tedenskem odprtem podaljšanju
If you have any questions about how Rilonacept Regeneron works or why this medicine has been prescribed for you, ask your doctor. 
Če imate kakšna vprašanja o tem, kako zdravilo Rilonacept Regeneron deluje ali zakaj so vam predpisali to zdravilo, vprašajte svojega zdravnika.
• Any other medicines for chronic disorders, as Rilonacept Regeneron can affect how the liver processes some medicines, such as warfarin (a blood thinner). 
• katerakoli druga zdravila za kronične bolezni, ker lahko zdravilo Rilonacept Regeneron vpliva na način, na katerega jetra predelujejo nekatera zdravila, na primer varfarin (zdravilo za redčenje krvi).
In studies of patients with CAPS, no ISRs were assessed as severe, and no patient discontinued study participation due to an ISR. 
V študijah bolnikov s CAPS nobene ISR niso bile ocenjene kot težke in noben bolnik ni izstopil iz študije zaradi ISR.
Endpoint Period (Weeks 22 to 24) 
Obdobje končnega stanja (tedni 22 do 24)
In addition the MAH is requested to assess cases for which there is loss of efficacy to determine whether this is due to changes over time in PK/PD or antibody development. 
Poleg tega mora imetnik dovoljenja za promet z zdravilom oceniti primere, pri katerih je prišlo do izgube učinkovitosti, da se ugotovi, ali je to posledica sprememb PK/PD, ki se pojavijo sčasoma, ali razvoja protiteles.
Part B 
Del B
The patient or care giver should be advised to speak to the treating physician before adjusting the dose. 
Bolniku ali negovalcu je treba svetovati, naj se pred prilagajanjem odmerka pogovori z lečečim zdravnikom.
Reproductive toxicity studies have been conducted in animals and have shown no effects on fertility or foetal morphology; however a study in pregnant monkeys showed reduced levels of oestrogen (see section 5.3). 
Pri živalih so opravili študije reproduktivne toksičnosti, ki niso pokazale učinkov na plodnost ali fetalno morfologijo, vendar je študija pri brejih opicah pokazala znižane ravni estrogena (glejte poglavje 5.3).
Four additional adolescents (12-17 years) all with a diagnosis of FCAS subsequently enrolled in the open label extension where efficacy assessments were not collected. 
Štirje dodatni mladostniki (12-17 let), od katerih so imeli vsi diagnozo FCAS, se je vključilo v odprto podaljšanje pozneje, ko ocen učinkovitosti niso zbirali.
Interleukin-1 (IL-1) blockade may interfere with immune response to infections. 
Blokada interlevkina-1 (IL-1) lahko ovira imunski odziv na okužbe.
This is clinically relevant for CYP450 substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g. warfarin). 
To je klinično pomembno za substrate CYP450 z ozkim terapevtskim oknom, kjer se odmerek prilagaja vsakemu bolniku posebej (npr. varfarin).
Active Rilonacept Baseline Period (Weeks 13 to 15) 
Aktivno izhodiščno obdobje z rilonaceptom (tedni 13 do 15)
Rilonacept Regeneron has not been tested in pregnant women and should not be used during pregnancy unless clearly necessary. 
Zdravila Rilonacept Regeneron niso preučevali pri nosečnicah, zato se ne sme uporabljati med nosečnostjo, razen če je to nujno.
The risk for the foetus/mother is unknown. 
Tveganje za plod/mater ni znano.
• The risk of serious infections, including opportunistic bacterial, viral and fungal infections in patients treated with Rilonacept Regeneron; 
• o tveganju resnih okužb, vključno z oportunističnimi bakterijskimi, virusnimi in glivičnimi okužbami, pri bolnikih, zdravljenih z zdravilom Rilonacept Regeneron;
The effect of race could not be assessed because only Caucasian patients participated in the clinical studies in CAPS, reflecting the epidemiology of the disease. 
Vpliva rase niso mogli ocenjevati, ker so v kliničnih študijah CAPS sodelovali samo belci, kar zrcali epidemiologijo bolezni.
If blood comes into the syringe, the needle has entered a blood vessel. 
Če se v brizgi pojavi kri, je igla vstopila v žilo.
The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary. 
Evropska agencija za zdravila bo vsaj enkrat letno ponovno pregledala nove podatke o tem zdravilu in posodobila navodilo za uporabo, če bo potrebno.
Choose the area for the injection. 
Izberite predel za injekcijo.
If necessary, the product may be kept at room temperature, but should be used within 3 hours of mixing. 
Če je potrebno, lahko zdravilo hranite pri sobni temperaturi, a ga morate porabiti v 3 urah po mešanju.
• SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES 
• SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
It is unknown whether the use of IL-1 inhibitors like rilonacept increases the risk of reactivation of TB or of opportunistic infections. 
Ni znano, ali uporaba zaviralcev IL-1, kakršen je rilonacept, zveča tveganje reaktivacije TB ali oportunističnih okužb.
Tumour necrosis factor (TNF) inhibitors have been associated with an increased risk of reactivation of latent tuberculosis (TB). 
Zaviralce faktorja tumorske nekroze (TNF) povezujejo z zvečanim tveganjem reaktivacije latentne tuberkuloze (TB).
However, clinical experience in patients above 65 years is limited, therefore caution is recommended. 
Vendar so klinične izkušnje pri bolnikih, starejših od 65 let, omejene, zato priporočamo previdnost.
Other medicines and Rilonacept Regeneron Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 
Druga zdravila in zdravilo Rilonacept Regeneron Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali, ali pa boste morda začeli jemati katero koli zdravilo.
The PSUR cycle for the medicinal product should follow a half-yearly cycle until otherwise agreed by the CHMP. 
PSUR Cikel PSUR za zdravilo mora slediti polletnemu ciklu, dokler CHMP ne odloči drugače.
Elderly (65 years old or older) 
Starejši bolniki (stari 65 let ali več)
Using a daily diary questionnaire, patients rated the following five signs and symptoms of CAPS: joint pain, rash, feeling of fever/chills, eye redness/pain, and fatigue, each on a scale of 0 (none, no severity) to 10 (very severe). 
Z uporabo vsakodnevnega vprašalnika v obliki dnevnika so bolniki ocenjevali naslednjih pet znakov in simptomov CAPS: bolečina v sklepih, izpuščaj, občutek vročine/mrzlice, rdečica oči/bolečina v očeh in utrujenost, in to vsakega na lestvici od 0 (nič, brez izraženosti) do 10 (zelo močno izražen).
• 3 alcohol wipes 
• 3 alkoholne zložence
Let the vial sit for about 1 minute. 
Nato naj viala približno 1 minuto miruje.
• Do not inject into skin that is tender, red, or hard. 
• Ne injicirajte v kožo, ki je občutljiva, trda ali rdeča.
Reported ISRs were generally mild to moderate in severity. 
ISR, o katerih so poročali, so bile po stopnji izraženosti na splošno blage do zmerne.
The solvent is a colourless liquid. 
Vehikel je brezbarvna tekočina.
STEP 5: Preparing the injection 
KORAK 5: Priprava injekcije
If a patient becomes neutropenic the ANC should be monitored closely and treatment discontinuation should be considered. 
Če bolnik postane nevtropeničen, je treba skrbno spremljati ANC, v poštev pride prekinitev zdravljenja.
• Allergic reactions. 
• Alergijske reakcije.
Blood and lymphatic system disorder 
Bolezni krvi in limfatičnega sistema
Hold the vial containing the mixture of powder and sterile water (solvent) sideways (not upright) with your thumb and a finger at the top and bottom of the vial, and quickly shake the vial back and forth (side-to-side) for about 1 minute. 
Držite vialo, ki vsebuje mešanico praška in sterilne vode (vehikla), postrani (ne pokonci) s palcem in kazalcem na vrhu in dnu viale in hitro stresajte vialo naprej in nazaj (z ene strani na drugo) približno 1 minuto.
The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Rilonacept Regeneron are provided with a physician information pack containing the following: 
Imetnik dovoljenja za promet z zdravilom (MAH) mora zagotoviti, da bodo pred uvedbo zdravila na trg vsi zdravniki, ki nameravajo predpisovati/izdajati zdravilo Rilonacept Regeneron, prejeli paket izobraževalnega gradiva za zdravnike, ki bo vseboval naslednje:
In Part A and Part B, physician's and patient's global assessment of disease activity and patients' assessment of the degree of limitation of their daily activities due to their disease were significantly improved for patients treated with rilonacept compared with those on placebo. 
V delu A in delu B se je zdravnikova in bolnikova globalna ocena aktivnosti bolezni in bolnikova ocena stopnje omejitve dnevnih aktivnosti zaradi bolezni signifikantno izboljšala pri bolnikih, zdravljenih z rilonaceptom, v primerjavi s tistimi na placebu.
Thus it is expected that for a molecule that binds to IL-1, such as rilonacept, the formation of CYP450 enzymes could be normalized. 
Zato je pričakovati, da bo molekula, ki se veže na IL-1, na primer rilonacept, lahko normalizirala nastajanje encimov s CYP450.
Bioavailability of rilonacept after a subcutaneous injection is estimated to be approximately 50%. 
Ocenjujejo, da je biološka uporabnost rilonacepta po subkutani injekciji približno 50 %.
It is not meant to go into any muscle, vein, or artery. 
Ni mišljeno, da bi šla v kako mišico, veno ali arterijo.
The observed incidence of antibody positivity in an assay may be influenced by several factors including assay sensitivity and specificity, sample handling, concomitant medicinal products, and underlying disease. 
Na opaženo incidenco pozitivnosti protiteles v testu lahko vpliva več dejavnikov, vključno z občutljivostjo in specifičnostjo testa, ravnanjem z vzorci, sočasnim jemanjem drugih zdravil in osnovno boleznijo.
A study of embryo-foetal development was conducted with rilonacept in monkeys at doses up to approximately 4 times the human dose. 
Pri opicah so opravili študijo embriofetalnega razvoja z rilonaceptom z odmerki, ki so bili do približno štirikrat večji od odmerka za človeka.
During the open-label extension, reductions in mean symptom scores, serum CRP, and serum SAA levels were maintained for up to one year. 
Med odprtim podaljšanjem so se zmanjšanje povprečnih izidov simptomov, znižanje plazemskega CRP in ravni plazemskega SAA vzdrževali do enega leta.
Do not touch the needle with your hands or allow it to come into contact with any surfaces. 
Ne dotaknite se igle z rokami in ne dovolite, da bi se igla dotaknila katerekoli površine.
By blocking the activity of IL-1 beta, Rilonacept Regeneron leads to an improvement in these symptoms. 
Z blokiranjem aktivnosti IL-1 beta zdravilo Rilonacept Regeneron povzroči izboljšanje teh simptomov.
The safety and efficacy of rilonacept for the treatment of CAPS, including patients with FCAS, also known as familial cold urticaria syndrome (FCUS), and MWS was demonstrated in a randomised, double-blind, placebo-controlled study with two parts (A and B) conducted sequentially in the same patients. 
Varnost in učinkovitost rilonacepta za zdravljenje CAPS, vključno z bolniki s FCAS, ki je znan tudi kot familiarni sindrom urtikarije zaradi mraza (FCUS), in MWS so dokazali v randomizirani, dvojno slepi, s placebom kontrolirani študiji v dveh delih (A in B), zaporedno opravljeni pri istih bolnikih.
Treatment should not be initiated in patients with an active or chronic infection (see section 4.3) and physicians should exercise caution when administering Rilonacept Regeneron to patients with a history of recurring infections or with underlying conditions that may predispose them to infections. 
Zdravljenja ne smemo uvesti pri bolnikih z aktivno ali kronično okužbo (glejte poglavje 4.3), zdravniki pa morajo biti previdni, kadar dajejo zdravilo Rilonacept Regeneron bolnikom z anamnezo ponavljajočih se okužb ali z osnovnimi boleznimi, ki jih lahko naredijo dovzetne za okužbe.
• To protect yourself and others from possible needle sticks, it is very important to throw away every syringe, with the needle attached, in the puncture-resistant container right after use. 
• Da sebe in druge zaščitite pred morebitnimi vbodi z iglo, je zelo pomembno, da po uporabi vsako iglo, pritrjeno na injekcijsko brizgo, zavržete v vsebnik, odporen na vbode.
Put the following items on a clean flat surface (see Figure 1): 
Naslednje predmete položite na čisto in ravno površino (glejte sliko 1):
• Areas where you may inject Rilonacept Regeneron include the left and right sides of the abdomen, and left and right thighs. 
• Predeli, kamor lahko injicirate zdravilo Rilonacept Regeneron, vključujejo levo in desno stran trebuha in levo in desno stegno.
Put the vial back on the table and let the vial sit for about 1 minute. 
Položite vialo spet na mizo, kjer naj miruje približno 1 minuto.
Wye Valley Business Park Brecon Road, Hay-on-Wye Hereford HR3 5PG United Kingdom 
Wye Valley Business Park Brecon Road, Hay-on-Wye Hereford HR3 5PG Velika Britanija
Improvement in key symptom scores was noted within one day of initiation of rilonacept therapy in most patients. 
Izboljšanje rezultatov ključnih simptomov so pri večini bolnikov opazili v enem dnevu po uvedbi zdravljenja z rilonaceptom.
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Rilonacept Regeneron should be made taking into account the benefit of breast-feeding to the child and the benefit of Rilonacept Regeneron therapy to the woman. 
Pri odločanju o nadaljevanju/prekinitvi dojenja oziroma nadaljevanju/prekinitvi zdravljenja z zdravilom Rilonacept Regeneron moramo upoštevati koristi dojenja za otroka in korist zdravljenja z zdravilom Rilonacept Regeneron za žensko.
Lipid profile changes 
Spremembe lipidnega profila
You or your caregiver will receive adequate training on how to mix the powder (dissolve to make a solution), prepare the dose, and administer the injection. 
Vas ali vašega negovalca bodo ustrezno izurili v mešanju praška (treba ga je raztopiti, da nastane raztopina), pripravljanju odmerka in dajanju injekcije.
Clean the top of the Rilonacept Regeneron vial with a fresh, never-used alcohol wipe, wiping in one direction around the top. 
Očistite vrh viale zdravila Rilonacept Regeneron z novim, neuporabljenim alkoholnim zložencem, tako da obrišete okrog vrha v eno smer.
After the addition of solvent, the vial contents should be reconstituted by shaking the vial for approximately one minute and then allowing it to sit for one minute. 
Po dodatku vehikla morate rekonstituirati vsebino viale, tako da vialo približno eno minuto stresate in jo nato pustite eno minuto stati.
Before starting treatment with Rilonacept Regeneron, all patients should be evaluated for both active and inactive (latent) tuberculosis. 
Pred začetkom zdravljenja z zdravilom Rilonacept Regeneron je treba vse bolnike pregledati glede aktivne in neaktivne (latentne) tuberkuloze.
Patients treated with rilonacept experienced more improvement in each of the five components of the composite endpoint than placebo-treated patients. 
Bolnikom, ki so jih zdravili z rilonaceptom, se je stanje izraziteje izboljšalo v vsaki od petih komponent sestavljenega končnega stanja kot bolnikom, ki so prejemali placebo.
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). 
Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Start over with ‘STEP 1: Setting up for an injection' using new supplies. 
Spet začnite s ‘KORAK 1: Priprava na injiciranje' in uporabite nove potrebščine.
Pre-treatment Baseline Period (Weeks -3 to 0) 
Izhodiščno obdobje pred zdravljenjem (tedni -3 do 0)
In patients with CAPS, the most common and consistently reported adverse event associated with treatment was injection-site reaction (ISR). 
Pri bolnikih s CAPS je bil najpogostejši neželeni dogodek, povezan z zdravljenjem, o katerem so dosledno poročali, reakcija na mestu injiciranja (ISR).
• OBLIGATION TO CONDUCT POST-AUTHORISATION MEASURES 
• OBVEZNOST IZVEDBE UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET
Rilonacept Regeneron is not recommended for children younger than 12 years of age. 
Zdravilo Rilonacept Regeneron ni priporočljivo za otroke, mlajše od 12 let.
If no blood appears, inject all the medicine in the syringe at a slow, steady rate, pushing the plunger all the way down. 
Če se kri ne pojavi, počasi in enakomerno vbrizgajte vse zdravilo v brizgi in potisnite bat do konca navzdol.
CL /F (l/day) 
CL /F (l/dan)
The sterile water should be at the 2.3-ml line (see Figure 6). 
Sterilna voda mora segati do črte 2,3 ml (glejte sliko 6).
• Alcohol wipes 
• alkoholni robčki;
Remove the needle cover and be careful not to touch the needle. 
Odstranite pokrovček igle in pazite, da se ne boste dotaknili igle.
• After that, the recommended dose is 2.2 milligrams per kilogram, up to 160 mg, once weekly on the same day of the week. 
• Temu sledi priporočeni odmerek 2,2 miligrama na kilogram, do 160 mg, enkrat na teden istega dne v tednu.
CONTENTS BY WEIGHT, BY VOLUMEN OR BY UNIT 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
Twelve additional patients enrolled during the open label extension in which efficacy data were collected, 8 adults with a diagnosis of FCAS and 4 adolescents (13-16 years old), 3 with FCAS and 1 with FCAS/MWS overlap. 
Med odprtim podaljšanjem, v katerem so zbirali podatke o učinkovitosti, se je vključilo 12 dodatnih bolnikov, 8 odraslih z diagnozo FCAS in 4 mladostniki (stari 13-16 let), 3 s FCAS in 1 s prekrivanjem FCAS in MWS.
An assessment of efficacy with respect to age group and diagnosis was obtained by comparing KSS at the end of the 24 week open label extension with KSS at baseline using time averaged daily mean scores. 
Oceno učinkovitosti glede starostne skupine in diagnoze so dobili tako, da so primerjali izide ključnih simptomov (key symptom scores, KSS) na koncu 24-tedenskega odprtega podaljšanja s KSS v izhodišču in pri tem uporabili dnevne srednje izide, povprečene za čas.
The MAH is requested to perform a PK study in children. 
Imetnik dovoljenja za promet z zdravilom mora opraviti PK študijo pri otrocih.