natgillin/translations-raw huggingface dataset:
Results from the Short Form Health Survey (SF 36) for all doses/schedules of adalimumab in all four studies support these findings, with statistically significant physical component summary (PCS) scores, as well as statistically significant pain and vitality domain scores for the 40 mg every other week dose.
Te izsledke podpirajo rezultati SF-36 (Short Form Health Survey) za vse odmerke/sheme adalimumaba v vseh štirih študijah, s statistično značilnim seštevkom PCS (Physical Component Summary) in statistično značilnima seštevkoma za področje bolečin in vitalnosti za odmerek 40 mg vsak drugi teden.
Should treatment be interrupted, Hulio may be re-introduced as appropriate.
Če je treba zdravljenje prekiniti, je možno zdravljenje z zdravilom Hulio znova uvesti, kakor je primerno.
• swollen face, hands or feet;
• oteklost obraza, dlani ali stopal;
• Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV infection or if you think you might be at risk of contracting HBV.
• Zdravniku povejte, če ste nosilec virusa hepatitisa B (HBV), če imate aktivno okužbo s HBV ali če mislite, da bi se lahko nalezli HBV.
If an anaphylactic reaction or other serious allergic reaction occurs, administration of Hulio should be discontinued immediately and appropriate therapy initiated.
Če se pojavi anafilaktična reakcija ali kakšna druga resna alergijska reakcija, je treba uporabo zdravila Hulio nemudoma prekiniti in uvesti ustrezno zdravljenje.
RA studies III and V had an additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
V študijah revmatoidnega artritisa III in V je bila dodatna primarna končna točka po 52 tednih upočasnitev napredovanja bolezni (ugotovljena z izvidi rentgenskega slikanja).
• Tell your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.
• Zdravniku povejte, če ste imeli v preteklosti ponavljajoče se okužbe ali druga stanja, ki povečujejo tveganje za okužbe.
No clinical data are available on the use of a Hulio loading dose in children < 6 years of age (see section 5.2).
Klinični podatki o uporabi polnilnega odmerka zdravila Hulio pri otrocih, mlajših od 6 let, niso na voljo (glejte poglavje 5.2).
The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in Table 6 below: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); and not known (cannot be estimated from the available data).
Naslednji seznam neželenih učinkov temelji na izkušnjah iz kliničnih preskušanj in iz obdobja trženja zdravila in jih razvršča po organskih sistemih in pogostnosti v spodnji preglednici 6: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) in neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
Adalimumab was numerically favoured for the majority of subscores with statistically significant mean differences for general vision, ocular pain, near vision, mental health, and total score in Study UV I, and for general vision and mental health in Study UV II.
Številke so bile v korist adalimumaba za večino podrezultatov s statistično značilno povprečno razliko za splošni vid, očesno bolečino, vid na blizu, duševno zdravje in skupen rezultat v študiji UV I ter za splošni vid in duševno zdravje v študiji UV II.
What Hulio looks like and contents of the pack
Izgled zdravila Hulio in vsebina pakiranja
- If you have a severe infection, including tuberculosis (see “Warnings and precautions”).
- če imate hudo okužbo, vključno s tuberkulozo (glejte ''Opozorila in previdnostni ukrepi'').
You should record the date when the pen is first removed from refrigerator, and the date after which it should be discarded.
Zapisati si morate datum, ko je bil peresnik prvič vzet iz hladilnika, in datum, po katerem ga je treba zavreči.
PASI 75 and PGA clear or minimal increased with increasing adalimumab concentrations, both with a similar apparent EC50 of approximately 4.5 μg/ml (95% CI 0.4-47.6 and 1.9-10.5, respectively).
PASI 75 in PGA čisto ali minimalno sta se povečevali z zvečanjem koncentracije adalimumaba, obe s podobno navidezno EC50, za približno 4,5 µg/ml (95 % IZ 0,4-47,6 in 1,9-10,5).
These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning).
Te okužbe so lahko resne in vključujejo tuberkulozo, okužbe, ki jih povzročijo virusi, glive, paraziti ali bakterije, ali druge neobičajne okužbe in sepso (zastrupitev krvi).
Treatment with adalimumab 40 mg every week significantly reduced the risk of worsening of abscesses and draining fistulas.
Zdravljenje z adalimumabom 40 mg vsak teden statistično pomembno zmanjša tveganje za poslabšanje abscesov in fistul z izcedkom.
Figure 2: Kaplan-Meier Curves Summarizing Time to Treatment Failure on or after week 6 (Study UV I) or week 2 (Study UV II)
Slika 2: Kaplan-Meierjeve krivulje povzemajo čas do neuspeha zdravljenja v ali po 6. tednu (študija UV I) ali 2. tednu (študija UV II)
Do not mix the Hulio solution with any other medicine.
Raztopine zdravila Hulio ne mešajte z drugimi zdravili.
In some rare cases, especially if your child is taking other medicines that suppress the immune system, reactivation of HBV infection can be life-threatening.
V nekaterih redkih primerih, zlasti če vaš otrok uporablja druga zdravila, ki zavirajo imunski sistem, je reaktivacija okužbe s HBV lahko življenjsko ogrožujoča.
Hulio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Zdravilo Hulio je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno.
In addition, no malignancies were observed in 192 paediatric patients with an exposure of 498.1 patient years during adalimumab trials in paediatric patients with Crohn's disease.
Poleg tega niso opazili nobenega malignoma niti pri 192 pediatričnih bolnikih, ki so bili izpostavljeni 498,1 bolnikovlet med študijami z adalimumabom pri pediatričnih bolnikih s Crohnovo boleznijo.
This will include a thorough medical evaluation including your medical history and screening tests (for example chest X-ray and a tuberculin test).
To bo vključevalo natančno zdravniško oceno, vključno s poizvedbo o zdravju v preteklosti, in preiskave (npr. rentgensko slikanje prsnega koša in tuberkulinski test).
Hulio may have a minor influence on the ability to drive and use machines.
Zdravilo Hulio ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
Step 1 - Choose and prepare injection site
1. korak - Izberite in pripravite injekcijsko mesto.
Orange Activator (Needle Inside)
Oranžni aktivator (z iglo)
Push the plunger rod gently in until the syringe contains the prescribed amount.
Nosilec bata previdno potiskajte v brizgo, dokler brizga ne vsebuje predpisane količine.
• bleeding in the stomach;
• krvavitve v želodcu;
- polyarticular juvenile idiopathic arthritis in children aged 2-17 years; - enthesitis-related arthritis in children aged 6-17 years; - Crohn's disease in children aged 6-17 years - plaque psoriasis in children aged 4-17 years; - hidradenitis suppurativa in adolescents aged 12-17 years; - chronic non-infectious uveitis in children aged 2-17 years affecting the front of the eye.
- poliartikularnega juvenilnega idiopatskega artritisa pri otrocih, starih od 2 do 17 let; - artritisa, povezanega z entezitisom, pri otrocih, starih od 6 do 17 let; - Crohnove bolezni pri otrocih, starih od 6 do 17 let; - luskavice (psoriaze) v plakih pri otrocih, starih od 4 do 17 let; - hidradenitis suppurativa pri mladostnikih, starih od 12 do 17 let; - kroničnega neinfekcijskega uveitisa pri otrocih, starih od 2 do 17 let, ki prizadene sprednji del očesa.
Gently squeeze the cleaned area of skin and hold firmly.
Nežno stisnite očiščeni predel kože in ga trdno držite.
If there are air bubbles in the syringe, push the plunger rod all the way back in to push the solution back into the vial.
Če so v brizgi zračni mehurčki, potisnite nosilec bata do konca nazaj, da boste raztopino potisnili nazaj v vialo.
2 alcohol pads
2 alkoholna zloženca
Antibiotics may be continued during treatment with Hulio if necessary.
Med zdravljenjem z zdravilom Hulio lahko nadaljujete z antibiotičnim zdravljenjem, če je potrebno.
Week 26 Clinical remission Clinical response Week 52 Clinical remission Clinical response * p value for Standard Dose versus Low Dose comparison.
26. teden Klinična remisija Klinični odziv 52. teden Klinična remisija Klinični odziv * vrednost p za primerjavo standardnega odmerka proti majhnemu odmerku
In CD Study III, at week 4, 58% (499/854) of patients were in clinical response and were assessed in the primary analysis.
V študiji Crohnove bolezni III je imelo 4. teden klinični odziv 58 % (499/854) bolnikov; ti so bili ocenjeni v primarni analizi.
Seek medical attention urgently if your child develops any of the following signs of allergic reaction or heart failure:
Nemudoma poiščite zdravniško pomoč, če se pri vašem otroku pojavi kateri koli od naslednjih znakov alergijske reakcije ali srčnega popuščanja:
P value*
Vrednost P*
• Tell your child's doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.
• Otrokovemu zdravniku povejte, če ste imeli v preteklosti ponavljajoče se okužbe ali druga stanja, ki povečujejo tveganje za okužbe.
The first received placebo injections every week for 52 weeks.
Prva je 52 tednov vsak teden dobivala injekcije placeba.
Hulio Mark your calendar with the stickers provided to remind you of the date for your next dose.
Hulio S priloženimi nalepkami si na koledarju označite datum, ko morate vzeti naslednji odmerek.
For more information on vaccines see the “Warnings and precautions” section.
Za več informacij glede cepiv glejte poglavje ''Opozorila in previdnostni ukrepi''.
• DO NOT remove the needle cap until you are ready to inject.
• Pokrovčka igle NE odstranjujte, dokler niste pripravljeni na injiciranje.
Hulio may have a minor influence on your ability to drive, cycle or use machines.
Zdravilo Hulio ima lahko blag vpliv na sposobnost vožnje, kolesarjenja ali upravljanja strojev.
Each pre-filled syringe has a safety feature, this will retract and cover the needle after the plunger is released.
Vsaka napolnjena injekcijska brizga ima varnostni sistem, ki uvleče in pokrije iglo, ko sprostite bat.
Injection site reaction (including injection site erythema)
zelo pogosti reakcija na mestu injiciranja (vključno z eritemom na mestu injiciranja)
If the needle did not retract, carefully place the used syringe into a sharps container to avoid injury.
Če se igla ne uvleče, previdno odložite uporabljeno injekcijsko brizgo v vsebnik za ostre predmete, da preprečite telesne poškodbe.
• DO NOT rub the injection site.
• Injekcijskega mesta NE DRGNITE.
Radiographs of hands, wrists, and feet were obtained at baseline and week 24 during the double-blind period when patients were on adalimumab or placebo and at week 48 when all patients were on open-label adalimumab.
Rentgenske posnetke dlani, zapestij in stopal so naredili izhodiščno in 24. teden v dvojno slepem obdobju, v katerem so bolniki dobivali adalimumab ali placebo, in 48. teden, ko so vsi bolniki odprto dobivali adalimumab.
Patients should be tested for HBV infection before initiating treatment with Hulio.
Bolnike je treba pred začetkom zdravljenja z zdravilom Hulio testirati na okužbo s HBV.
An embryo-foetal developmental toxicity/perinatal developmental study has been performed in cynomolgus monkeys at 0, 30 and 100 mg/kg (9-17 monkeys/group) and has revealed no evidence of harm to the foetuses due to adalimumab.
Raziskava embrio-fetalne razvojne toksičnosti/perinatalnega razvoja je bila izvedena pri opicah Cynomolgus z odmerki 0, 30 in 100 mg/kg (od 9 do 17 opic na skupino) in ni pokazala znakov okvare plodov zaradi adalimumaba.
Treatment with Hulio may result in the formation of autoimmune antibodies.
Zdravljenje z zdravilom Hulio lahko povzroči nastanek avtoimunskih protiteles.
Significant improvements at week 16 from baseline compared to placebo (Studies I and II) and MTX (Study II) were demonstrated in the DLQI (Dermatology Life Quality Index).
Značilno izboljšanje od izhodišča do 16. tedna se je v primerjavi s placebom (študiji I in II) in metotreksatom (študija II) izkazalo v dermatološkem indeksu kakovosti življenja (DLQIDermatology Life Quality Index).
• It is important to tell your child's doctor if your child had or have a serious heart condition.
• Pomembno je, da otrokovemu zdravniku poveste, če je vaš otrok imel ali ima kakšno resno bolezen srca.
Hulio can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Zdravilo Hulio je mogoče uporabljati tudi za zdravljenje hudega, aktivnega in napredujočega revmatoidnega artritisa brez predhodnega zdravljenja z metotreksatom.
• Tell your child's doctor if your child is a carrier of the hepatitis B virus (HBV), if he/she has active HBV infection or if you think he/she might be at risk of contracting HBV.
• Otrokovemu zdravniku povejte, če je vaš otrok nosilec virusa hepatitisa B (HBV), če ima aktivno okužbo s HBV ali če mislite, da bi se lahko nalezel HBV.
Push the white plunger rod to inject the Hulio solution until the syringe is empty.
Potiskajte beli nosilec bata, da injicirate raztopino zdravila Hulio, dokler ni brizga prazna.
• Do not use the 40 mg pre-filled syringe if doses other than 40 mg are recommended.
• Ne uporabljajte 40 mg napolnjenega injekcijskega peresnika, če so priporočeni drugi odmerki kot 40 mg.
In rheumatoid arthritis, methotrexate is continued while using Hulio.
Pri revmatoidnem artritisu se uporaba metotreksata med uporabo zdravila Hulio nadaljuje.
Do not attempt to give your child an injection until you are sure that you understand how to do this.
Ne poskušajte dati injekcije svojemu otroku, dokler postopka popolnoma ne obvladate.
Alternatively, if a patient has stopped Hulio and signs and symptoms of disease recur, Hulio may be re-administered.
Če bolnik neha uporabljati zdravilo Hulio ter se znaki in simptomi bolezni ponovijo, je mogoče zdravilo Hulio znova uvesti.
The criteria determining treatment failure were worsening or sustained non-improvement in ocular inflammation, partial improvement with development of sustained ocular co-morbidities or worsening of ocular co-morbidities, non-permitted use of concomitant medications, and suspension of treatment for an extended period of time.
Merila, s katerimi so določali neuspeh zdravljenja, so bila poslabšanje ali vztrajno ne-izboljšanje očesnega vnetja, delno izboljšanje z razvojem trajnih sočasnih očesnih bolezni ali poslabšanjem sočasnih očesnih bolezni, nedovoljena uporaba sočasnih zdravil ter prekinitev zdravljenja za daljše časovno obdobje.
Continue holding down after hearing the 1st
Peresnik držite navzdol tudi, ko zaslišite prvi »KLIK«.
During 52 weeks of studies UC-I and UC-II, lower rates of all-cause hospitalisations and UC-related hospitalisations were observed for the adalimumab-treated arm compared to the placebo arm.
Po 52 tednih trajanja študije UC-I in UC-II so opazili nižjo stopnjo hospitalizacije iz vseh razlogov in hospitalizacije, povezane z ulceroznim kolitisom, pri skupini, zdravljeni z adalimumabom, v primerjavi s skupino s placebom.
Set the syringe with covered needle on the work surface.
Brizgo s pokrito iglo odložite na delovno površino.
These include rare reports of pancytopenia, aplastic anaemia, central and peripheral demyelinating events and reports of lupus, lupus-related conditions and Stevens-Johnson syndrome.
To vključuje redka poročila o pancitopeniji, aplastični anemiji, centralnih in perifernih demielinizacijskih dogodkih in poročila o lupusu, stanjih, povezanih z lupusom, in Stevens-Johnsonovem sindromu.
• As cases of tuberculosis have been reported in patients treated with adalimumab, your child's doctor will check your child for signs and symptoms of tuberculosis before starting Hulio.
• Ker so bili pri bolnikih, zdravljenih z adalimumabom, opisani primeri tuberkuloze, bo zdravnik vašega otroka pred začetkom zdravljenja z zdravilom Hulio preiskal glede znakov in simptomov tuberkuloze.
In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV infection can be life-threatening.
V redkih primerih, zlasti če uporabljate druga zdravila, ki zavirajo imunski sistem, je reaktivacija okužbe s HBV lahko življenjsko ogrožujoča.
• cancer of the lymph system (lymphoma);
• rak limfnega sistema (limfom);
During treatment with Hulio, other concomitant therapies (e.g., corticosteroids and/or immunomodulatory agents) should be optimised.
Med zdravljenjem z zdravilom Hulio je treba optimizirati druge sočasne terapije (npr. kortikosteroide in/ali imunomodulacijska zdravila).
Each Hulio single vial box will contain:
Škatla z eno vialo zdravila Hulio vsebuje:
If you are injecting into the abdomen, choose a site that is at least 5 cm away from the belly button.
Če injekcijo dajete v trebuh, izberite mesto, ki je vsaj 5 cm proč od popka.
At week 16, a statistically significantly greater proportion of patients who received adalimumab achieved PGA of 'clear' or 'almost clear' for the hands and/or feet compared to patients who received placebo (30.6% versus 4.3%, respectively [P = 0.014]).
V 16. tednu je statistično pomembno večji delež bolnikov, ki so prejemali adalimumab, doseglo PGA »čisto« ali »skoraj čisto« za dlani in/ali stopala v primerjavi z bolniki, ki so prejemali placebo (30,6 % proti 4,3 %, v tem zaporedju [P = 0,014]).
You should continue to inject Hulio for as long as your doctor has told you.
Z injiciranjem zdravila Hulio morate nadaljevati tako dolgo, kot vam je naročil zdravnik.
Your doctor may prescribe another strength of Hulio if your child needs a different dose.
Zdravnik lahko predpiše vašemu otroku drugo jakost zdravila Hulio, če vaš otrok potrebuje drugačen odmerek.
Your doctor may prescribe another strength of Hulio if you need a different dose.
Zdravnik vam lahko predpiše drugo jakost zdravila Hulio, če potrebujete drugačen odmerek.
Hulio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1).
Zdravilo Hulio je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno (za učinkovitost monoterapije glejte poglavje 5.1).
Hulio works by reducing this inflammation.
Zdravilo Hulio deluje tako, da zmanjša to vnetje.
The serum levels of free adalimumab (not bound to anti-adalimumab antibodies, AAA) were observed to be lower in patients with measurable AAA.
Ugotovljeno je bilo, da so koncentracije prostega adalimumaba (tistega, ki ni vezan na protitelesa proti adalimumabu, AAA) v serumu manjše pri bolnikih, ki imajo merljivo raven teh protiteles.
Do not attempt to self-inject until you are sure that you understand how to prepare and administer the injection.
Ne poskušajte si dati injekcije, dokler popolnoma ne obvladate priprave in dajanja injekcije.
Table 15: Efficacy Response in Placebo-Controlled Period for Study nr-axSpA II Double-Blind
Preglednica 15: Odziv učinkovitosti v s placebom kontroliranem obdobju študije nr-axSpA II Dvojno slepa
Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from Baseline) rates are presented in Table 26.
Stopnji klinične remisije in kliničnega odziva (definiran kot zmanjšanje vrednosti PCDAI vsaj za 15 točk od začetne vrednosti) sta predstavljeni v preglednici 26.
The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3 μg/ml (95% CI: 1-6 μg/ml).
Navidezna koncentracija adalimumaba v plazmi, ki doseže polovico največje verjetnosti odziva Ped ACR 50 (EC50), je bila 3 µg/ml (95 % IZ: 1-6 µg/ml).
- If your child has a severe infection, including tuberculosis (see “Warnings and precautions”).
- če ima vaš otrok hudo okužbo, vključno s tuberkulozo (glejte ''Opozorila in previdnostni ukrepi'').
Step 7 - Begin injection Step 8 - Hold down for 2nd “CLICK” & 10 seconds
8. korak - Držite navzdol, dokler ne slišite drugega »KLIKA« in ne mine 10 sekund.
It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks.
Najpogosteje prizadene specifične predele kože, kot so predel pod prsmi, pod pazduhami, notranji del stegen, dimlje in zadnjica.
Steroid-free remission for ≥ 90 days a
Remisija brez steroidov za ≥ 90 dnia
Step 12 - Prepare injection site
12. korak - Pripravite injekcijsko mesto.
Usually, Hulio is used with methotrexate.
Zdravilo Hulio ponavadi uporabljamo z metotreksatom.
• the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
• zdravljenje hudega, aktivnega in progresivnega revmatoidnega artritisa pri odraslih, ki prej še niso dobivali metotreksata.
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually first appear in childhood.
Poliartikularni juvenilni idiopatski artritis in artritis, povezan z entezitisom, sta vnetni bolezni sklepov, ki se običajno prvič pojavita v otroštvu.
Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Hulio.
Bolnike je zato treba pred, med in po zdravljenju z zdravilom Hulio natančno spremljati glede okužb, vključno s tuberkulozo.
What you need to know before you use Hulio
Kaj morate vedeti, preden boste uporabili zdravilo Hulio
Injection steps
Koraki za injiciranje
Patients requiring a dose less than 40 mg should use the 40 mg vial presentation of Hulio.
Bolniki, ki potrebujejo manj kot 40 mg odmerek, naj uporabijo 40 mg vialo zdravila Hulio.
Should treatment be interrupted, Hulio 40 mg every week or 80 mg every other week may be reintroduced (see section 5.1).
Če je potrebno z zdravljenjem prekiniti, lahko ponovno uvedete zdravljenje z zdravilom Hulio z odmerkom 40 mg vsak teden ali 80 mg vsak drugi teden (glejte poglavje 5.1).
N/A
(n/N)
• Do not give Hulio to children with polyarticular juvenile idiopathic arthritis and chronic non infectious uveitis below the age of 2 years.
• Zdravila Hulio ne smete dati otroku s poliartikularnim juvenilnim idiopatskim artritisom in kroničnim neinfekcijskim uveitisom, če je star manj kot 2 leti.
Hulio in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Zdravilo Hulio je v kombinaciji z metotreksatom indicirano za zdravljenje aktivnega poliartikularnega juvenilnega idiopatskega artritisa pri bolnikih od 2. leta starosti, ki se ne odzovejo ustrezno na eno ali več imunomodulirajočih antirevmatičnih zdravil (DMARD).
There is limited experience in the initiation of treatment with adalimumab alone.
Izkušnje z uvedbo zdravljenja samo z adalimumabom so omejene.
• vertigo (sensation of the room spinning);
• vertigo (občutek vrtenja);
• DO NOT put the needle cap back on the needle after it has been removed.
• NE NAMEŠČAJTE pokrovčka igle nazaj na iglo, potem ko ste ga odstranili.
At week 12 and week 24, PedACR30 response was 93.5% and 90.0%, respectively, using the observed data approach.
12. teden je bil odziv Ped ACR 30 93,5 % in 24. teden 90,0 % (z uporabo pristopa z opaženimi podatki).
• Check the solution in the vial is clear, colourless and has no particles.
• Prepričajte se, da je raztopina v viali bistra, brezbarvna in da ne vsebuje nobenih delcev.