natgillin/translations-raw huggingface dataset:
Patients in clinical response (decrease in CDAI ≥70) at week 4 were stratified and analysed separately from those not in clinical response at week 4.
Bolnike s kliničnim odzivom (znižanje CDAI ≥ 70) 4. teden so stratificirali in analizirali ločeno od bolnikov brez kliničnega odziva 4. teden.
The highest dose level evaluated has been multiple intravenous doses of 10 mg/kg, which is approximately 15 times the recommended dose.
Največji ocenjeni odmerek je obsegal večkratno intravensko aplikacijo 10 mg/kg, kar je približno 15-kraten priporočen odmerek.
If retreatment with Imraldi is indicated, the above guidance on dose and treatment duration should be followed.
Če je indicirano vnovično zdravljenje z zdravilom Imraldi, je treba upoštevati zgoraj navedena navodila za odmerjanje in trajanje zdravljenja.
- If you have moderate or severe heart failure.
- če imate zmerno ali hudo srčno popuščanje.
Thus additional caution should be exercised in considering adalimumab treatment of these patients (see section 4.8).
Torej je potrebna dodatna previdnost, kadar razmišljamo o zdravljenju z adalimumabom pri teh bolnikih (glejte poglavje 4.8).
Tuberculosis can develop during therapy even if your child has received preventative treatment for tuberculosis.
Tuberkuloza se lahko razvije med zdravljenjem, tudi če je vaš otrok prejel preventivno zdravljenje za tuberkulozo.
• difficulty sleeping;
• otežkočeno spanje;
By attaching to TNFα, Imraldi decreases the process of inflammation in these diseases.
S tem, ko se pritrdi na TNFα, zdravilo Imraldi zmanjšuje vnetni proces pri teh boleznih.
Treatment with Imraldi can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Zdravljenje z zdravilom Imraldi se lahko začne v kombinaciji s kortikosteroidi in/ali z drugimi nebiološkimi imunomodulatorji.
If you receive Imraldi while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy.
Če prejemate zdravilo Imraldi med nosečnostjo, obstaja večje tveganje, da bo vaš otrok dobil okužbo do približno pet mesecev po zadnjem odmerku, ki ste ga prejeli med nosečnostjo.
• severe rash, hives or other signs of allergic reaction;
• hud izpuščaj, koprivnico ali druge znake alergijske reakcije;
Patients may first be given other medicines.
Bolniki bodo morda najprej dobili druga zdravila.
Contact your doctor, nurse or pharmacist.
Obrnite se na zdravnika, medicinsko sestro ali farmacevta.
In study UC-II, treatment with adalimumab resulted in improvements in the Inflammatory Bowel Disease Questionnaire (IBDQ) score.
V študiji UC-II je zdravljenje z adalimumabom pripeljalo do izboljšanja rezultatov Vprašalnika o vnetni bolezni črevesa (IBDQ - Inflammatory Bowel Disease Questionnaire).
• To reduce the chance of infection, wipe the injection site with the other alcohol pad.
• Za zmanjšanje možnosti okužbe obrišite mesto injiciranja s priloženim alkoholnim zložencem.
Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.
Adalimumab je rekombinantno humano monoklonsko protitelo, ki nastaja v celicah jajčnika kitajskega hrčka.
• Using a piece of gauze, apply pressure over the injection site for 10 seconds.
• S koščkom gaze 10 sekund pritiskajte na mesto injiciranja.
Prior to launch of Imraldi in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including distribution modalities, and any other aspects of the programme, with the National Competent Authority.
• Dodatni ukrepi za zmanjševanje tveganj Pred začetkom trženja zdravila Imraldi v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom (MAH) s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega programa, vključno z modalitetami distribucije in vsemi drugimi vidiki programa.
Side effects may occur up to 4 months or more after the last Imraldi injection.
Neželeni učinki se lahko pojavijo do 4 mesece po zadnji injekciji zdravila Imraldi ali pozneje.
The European Medicines Agency has deferred the obligation to submit the results of the studies with the reference medicinal product containing adalimumab in one or more subsets of the paediatric population in ulcerative colitis, see section 4.2 for information on paediatric use.
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z referenčnim zdravilom, ki vsebuje adalimumab, za eno ali več podskupin pediatrične populacije pri ulceroznem kolitisu (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Tuberculosis can develop during therapy even if you have received preventative treatment for tuberculosis.
Tuberkuloza se lahko razvije med zdravljenjem, tudi če ste prejeli preventivno zdravljenje za tuberkulozo.
Among the patients who discontinued the study prior to week 78, 11% discontinued due to adverse events, and 5 % due to insufficient response to adalimumab treatment.
Med bolniki, ki so prekinili študijo pred 78. tednom, jih je 11 % prekinilo študijo zaradi neželenih učinkov in 5 % zaradi nezadostnega odziva na zdravljenje z adalimumabom.
What Imraldi is and what it is used for 2.
Kaj je zdravilo Imraldi in za kaj ga uporabljamo 2.
• Hold the syringe at eye-level with the needle pointing up to see the amount clearly.
• Držite brizgo na ravni oči in z iglo obrnjeno navzgor, da boste jasno videli količino.
Fistula remission3
Remisija fistule3
For instructions for use, refer to section 7.
Za navodila za uporabo glejte poglavje 7.
• If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice about taking this medicine.
• Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
• Look at the expiry date on the box to be used.
• Preverite rok uporabnosti na škatli.
These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, other opportunistic infections (unusual infections associated with a weakened immune system) and sepsis (blood poisoning).
Te okužbe so lahko resne in vključujejo tuberkulozo, okužbe, ki jih povzročijo virusi, glive, paraziti ali bakterije, druge oportunistične okužbe (neobičajne okužbe, povezane z oslabljenim imunskim sistemom) in sepso (zastrupitev krvi).
Adalimumab significantly decreased the risk of treatment failure by 75 % relative to placebo, as shown by the hazard ratio (HR = 0.25 [95 % CI: 0.12, 0.49]).
Adalimumab je značilno zmanjšal tveganje za neuspeh zdravljenja za 75 % glede na placebo, kot prikazuje razmerje ogroženosti (HR = 0,25 [95 % IZ: 0,12, 0,49]).
• If you received Imraldi during your pregnancy, your baby may have a higher risk for getting an infection.
• Če prejemate zdravilo Imraldi med nosečnostjo, obstaja večje tveganje, da bo vaš dojenček dobil okužbo.
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 je osnovan na izkušnjah iz kliničnih preskušanj in iz obdobja trženja zdravila in jih razvršča po organskih sistemih in pogostnosti v preglednici 6, spodaj: 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) (< 1/10.000).
You and your doctor should pay special attention to signs of infection while you are being treated with Imraldi.
Vi sami in zdravnik morata biti posebej pozorna na znake okužbe, medtem ko ste zdravljeni z zdravilom Imraldi.
Before initiation of therapy with Imraldi, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
Pred začetkom zdravljenja z zdravilom Imraldi je vse bolnike treba pregledati glede aktivne ali neaktivne (latentne) tuberkulozne okužbe.
The following instructions explain how to inject Imraldi.
Spodnja navodila pojasnjujejo, kako injicirati zdravilo Imraldi.
DO NOT touch the vial adapter.
NE DOTIKAJTE se adapterja za vialo.
These infections have not consistently been recognised in patients taking TNF-antagonists and this has resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes.
Takšnih okužb pri uporabnikih antagonistov TNF niso konsistentno prepoznavali, zato je v primerih njihovega nastanka prihajalo do zamud pri ustreznem zdravljenju, kar je včasih povzročilo smrt.
- If your child has moderate or severe heart failure.
- če ima vaš otrok zmerno ali hudo srčno popuščanje.
• On rare occasions, treatment with Imraldi could result in lupus-like syndrome.
• V redkih primerih lahko zdravljenje z zdravilom Imraldi povzroči lupusu podoben sindrom.
Clinical remission (defined as Mayo score ≤2 with no subscore >1) was assessed at week 8.
Klinično remisijo (opredeljeno kot ocena Mayo ≤ 2 in nobena podocena > 1) so ocenili 8. teden.
Patients on adalimumab may receive concurrent vaccinations, except for live vaccines.
Bolniki, ki prejemajo adalimumab, lahko sočasno dobijo cepiva, razen živih cepiv.
• immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);
• imunske bolezni, ki lahko prizadenejo pljuča, kožo in limfne vozle (najpogosteje kot stanje, ki mu pravimo sarkoidoza);
Caring for your vial
Skrb za vašo vialo
P value*
Vrednost p*
Hold the pen against your skin until the yellow indicator fills the medication window and stops moving.
Peresnik držite pritisnjen ob kožo, dokler rumeni indikator na zapolni okenca za zdravilo in se neha premikati.
During the withdrawal period, symptoms of psoriasis returned over time with a median time to relapse (decline to PGA “moderate” or worse) of approximately 5 months.
Med obdobjem prenehanja uporabe so se simptomi psoriaze sčasoma znova pojavili; mediani čas do ponovitve simptomov psoriaze (relapsa) (poslabšanje na PGA "zmerno" ali slabše) je bil približno 5 mesecev.
Patients may first be given other disease-modifying medicines, such as methotrexate.
Bolniki morda najprej dobijo druga imunomodulirajoča zdravila, npr. metotreksat.
• In some patients the body may fail to produce enough of the blood cells to fight off infections or help you to stop bleeding.
• Pri nekaterih bolnikih telo ne ustvari dovolj krvnih celic za premagovanje okužb ali ustavitev krvavitve.
• Imraldi is a liquid that is clear and colourless.
• Zdravilo Imraldi je bistra in brezbarvna tekočina.
Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Imraldi.
Kortikosteroide, ki se jih daje sočasno, se lahko postopoma ukinja v skladu s klinično prakso, z začetkom dva tedna po začetku zdravljenja z zdravilom Imraldi.
In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult patients.
Na splošno so bili neželeni učinki pri pediatričnih bolnikih po pogostnosti in vrsti podobni neželenim učinkom, opaženim pri odraslih bolnikih.
Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Imraldi in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
O uporabi protituberkuloznega profilaktičnega zdravljenja morate pred uvedbo zdravila Imraldi razmisliti tudi pri bolnikih z več ali pomembnimi faktorji tveganja za tuberkulozo kljub negativnemu testu za tuberkulozo in pri bolnikih z anamnezo latentne ali aktivne tuberkuloze, pri katerih ni mogoče potrditi ustreznega zdravljenja.
• If a large air bubble or air gap can be seen near the syringe tip, SLOWLY push the white plunger rod into the syringe until fluid begins to enter the syringe tip.
• Če opazite velik zračni mehurček ali zračni presledek pri konici brizge, POČASI potisnite beli nosilec bata v brizgo, dokler ne začne tekočina vstopati v konico brizge.
If the remaining volume is less than the prescribed dose volume, DO NOT use the syringe and contact your healthcare provider.
Če je preostala količina manjša od količine predpisanega odmerka, brizge, NE UPORABITE in se posvetujte z zdravnikom.
Analysis Treatment
Analiza Zdravljenje
• Use each vial only once.
• Vsako vialo uporabite samo enkrat.
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 pri Crohnovi bolezni III je imelo 4. teden klinični odziv 58 % (499/854) bolnikov; ti so bili ocenjeni v primarni analizi.
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 narejena 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.
Drop outs due to reasons other than treatment failure were censored at the time of dropping out.
Prekinitve sodelovanja zaradi razlogov, ki niso bili posledica neuspeha zdravljenja, so bile cenzurirane ob prekinitvi sodelovanja.
Patients who had been randomised to placebo in Period A were assigned to receive placebo in Period B.
Bolniki, ki so jih randomizirali na placebo v obdobju A, so v obdobju B prejemali placebo.
If active tuberculosis is diagnosed, Imraldi therapy must not be initiated (see section 4.3).
Če se odkrije aktivna tuberkuloza, se zdravljenja z zdravilom Imraldi ne sme začeti (glejte poglavje 4.3).
• DO NOT touch the needle.
• Igle se NE DOTIKAJTE.
Patients were permitted to be either disease-modifying, anti-rheumatic drug-naïve or to remain on their pre-existing rheumatologic therapy provided that therapy was stable for a minimum of 28 days.
Bolniki so bili lahko bodisi naivni za imunomodulirajoča antirevmatična zdravila bodisi so ohranili svojo prejšnjo revmatološko terapijo pod pogojem, da je bila ta terapija stabilna vsaj 28 dni.
Treatment with Imraldi should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Zdravljenja z zdravilom Imraldi se ne sme začeti pri bolnikih z aktivnimi okužbami, vključno s kroničnimi ali lokaliziranimi, dokler te niso obvladane.
Also, this medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially ‘sodium-free'.
Poleg tega to zdravilo vsebuje manj kot 1 mmol natrija (23 mg) v 0,8 ml odmerku, kar v bistvu pomeni "brez natrija".
Tell your child's doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
Obvestite zdravnika svojega otroka ali farmacevta, če vaš otrok jemlje, je pred kratkim jemal ali pa bo morda začel jemati katero koli drugo zdravilo.
• elevated bilirubin measurement (liver blood test).
• povečane vrednosti bilirubina (krvni test jetrne funkcije).
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, dosegel 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]).
Again, SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose, this is important to get the proper dose and important in order to prevent air bubbles or air gaps in the liquid medication.
POČASI potegnite beli nosilec bata ven, tako da je 0,1 ml preko predpisanega odmerka; to je pomembno, da boste dobili pravilen odmerek in da boste preprečili zračne mehurčke ali zračne presledke v tekočem zdravilu.
Erosion Score JSNd Score a methotrexate b 95 % confidence intervals for the differences in change scores between methotrexate and adalimumab.
Ocena erozij Ocena ZSŠd a metotreksat b 95-% intervali zaupanja za razlike v spremembi ocen med metotreksatom in adalimumabom.
Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Imraldi (see section 4.4).
Oftalmologom se svetuje, da se pred začetkom zdravljenja z zdravilom Imraldi posvetujejo z ustreznim specialistom (glejte poglavje 4.4).
HS Study II
Študija HS II
In post-marketing experience from January 2003 to December 2010, predominantly in patients with rheumatoid arthritis, the reported rate of malignancies is approximately 2.7 per 1,000 patient treatment years.
V obdobju pomarketinške uporabe od januarja 2003 do decembra 2010, pretežno pri bolnikih z revmatoidnim artritisom, je bil zabeleženi delež malignomov približno 2,7 na 1.000 bolnikov-let zdravljenja.
Treatment with adalimumab 40 mg every week significantly reduced the risk of worsening of abscesses and draining fistulas.
Zdravljenje s 40 mg adalimumaba vsak teden statistično zmanjša tveganje za poslabšanje abscesov in fistul z izcedkom.
Double-Blind Response at Week 68
Odziv v 68. tednu
Induction of clinical remission (defined as CDAI <150) was evaluated in two studies, CD study I (CLASSIC I) and CD study II (GAIN).
Indukcijo klinične remisije (opredeljene kot CDAI < 150) so ocenili v dveh študijah, študiji pri Crohnovi bolezni I (CLASSIC I) in študiji pri Crohnovi bolezni II (GAIN).
Other medicines and Imraldi
Druga zdravila in zdravilo Imraldi
The frequency of serious infections among adalimumab treated subjects over 65 years of age (3.7%) was higher than for those under 65 years of age (1.5%).
Pri bolnikih nad 65 let, ki so prejemali adalimumab, je bila pogostost resnih okužb večja (3,7 %) kot pri tistih pod 65 let starosti (1,5 %).
Always make sure your medicine is clear, free of particles, and has not expired.
Vedno se prepričajte, da je vaše zdravilo bistro, da v njem ni delcev ter da se rok uporabnosti zdravila še ni iztekel.
Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), Paediatric ACR 50 response, and Paediatric ACR 70 response.
Čeprav ni statistično značilno, je bilo pri večini bolnikov dokazano klinično izboljšanje sekundarnih opazovanih dogodkov, kot so število mest entezitisa, število občutljivih sklepov, število oteklih sklepov, odziv glede na merila Paediatric ACR 50 in Paediatric ACR 70.
• Remove the clear needle cap by pulling it straight up with your other hand.
• Odstranite prozorni pokrovček igle tako, da ga z drugo roko potegnete naravnost navzgor.
Dose + 0.1 ml
Odmerek + 0,1 ml
ASASa 40 ASAS 20 ASAS 5/6 ASAS partial remission BASDAIb 50
ASAS 5/6 ASAS delno izboljšanje
Reduction in HS-related skin pain was assessed using a Numeric Rating Scale in patients who entered the study with an initial baseline score of 3 or greater on a 11 point scale.
Zmanjšanje bolečine, povezane s HS, so ocenili s pomočjo numerične ocenjevalne lestvice pri bolnikih, ki so imeli pri vključitvi v študijo izhodiščni rezultat 3 ali več na 11-stopenjski numerični ocenjevalni lestvici.
Population pharmacokinetic analyses with data from over 1,300 RA patients revealed a trend toward higher apparent clearance of adalimumab with increasing body weight.
Analize populacijske farmakokinetike s podatki za več kot 1.300 bolnikov z revmatoidnim artritisom so pokazale trend k večjemu navideznemu očistku adalimumaba z večanjem telesne mase.
• cancer, including cancer of the lymph system (lymphoma) and melanoma (a type of skin cancer);
• rak, vključno z rakom limfnega sistema (limfomom) in melanomom (vrsto kožnega raka);
You might accidentally stick yourself or waste medication.
Poleg tega bi se lahko nehote zbodli ali pomotoma iztisnili zdravilo.
In patients who develop HBV reactivation, Imraldi should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Pri bolnikih, ki se jim pojavi reaktivacija HBV, je treba uporabo zdravila Imraldi prekiniti in uvesti učinkovito protivirusno terapijo z ustreznim podpornim zdravljenjem.
In a prospective cohort registry, 257 women with rheumatoid arthritis (RA) or Crohn's disease (CD) treated with adalimumab at least during the first trimester and 120 women with RA or CD not treated with adalimumab were enrolled.
V predvidenem kohortnem registru je bilo vključenih 257 žensk z revmatoidnim artritisom (RA) ali Crohnovo boleznijo (CB), zdravljenih z adalimumabom vsaj v prvem trimesečju nosečnosti, in 120 žensk z RA ali CB, ki niso bile zdravljene z adalimumabom.
Psoriasis study I (REVEAL) evaluated 1,212 patients within three treatment periods.
Študija pri psoriazi I (REVEAL) je ocenila 1.212 bolnikov v treh obdobjih zdravljenja.
If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Imraldi, and in accordance with local recommendations.
Če ugotovite latentno tuberkulozo, morate pred uvedbo zdravila Imraldi začeti s protituberkuloznim profilaktičnim zdravljenjem v skladu z lokalnimi priporočili.
If your medication is not clear, free of particles, or expired, do not use it.
Če vaše zdravilo ni bistro in brez delcev ali če se je rok uporabnosti iztekel, ga ne uporabite.
• Imraldi should only be used during a pregnancy if needed.
• Zdravilo Imraldi se med nosečnostjo lahko uporablja samo, če je potrebno.
After injecting Imraldi, confirm that the needle has retracted and immediately throw away the used syringe in a special container as instructed by your doctor, nurse or pharmacist.
Po injiciranju zdravila Imraldi se prepričajte, da je igla v celoti zdrsnila nazaj v ohišje injekcijske brizge in takoj zavrzite uporabljeno injekcijsko brizgo v poseben vsebnik, kot so vam naročili zdravnik, medicinska sestra ali farmacevt.
If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Imraldi and is positive for antibodies against double-stranded DNA, further treatment with Imraldi should not be given (see section 4.8).
Če se bolniku po zdravljenju z zdravilom Imraldi pojavijo simptomi, ki nakazujejo lupusu podobni sindrom, in ima pozitivna protitelesa proti dvojnoverižni DNA, zdravljenja z zdravilom Imraldi ne sme nadaljevati (glejte poglavje 4.8).
Similar trends (not all statistically significant) were seen in the smaller randomised, double − blind, placebo controlled AS study II of 82 adult patients with active ankylosing spondylitis.
Podobni trendi (ki pa niso bili vsi statistično značilni) so bili opazni v manjši, randomizirani, dvojno slepi, s placebom kontrolirani študiji pri ankilozirajočem spondilitisu II pri 82 odraslih bolnikih z aktivnim ankilozirajočim spondilitisom.
Efficacy of adalimumab for the treatment of adolescent patients with HS is predicted based on the demonstrated efficacy and exposure-response relationship in adult HS patients and the likelihood that the disease course, pathophysiology, and drug effects are substantially similar to that of adults at the same exposure levels.
Učinkovitost adalimumaba za zdravljenje mladostnikov s HS je napovedana na podlagi dokazane učinkovitosti in razmerja med izpostavljenostjo in odzivom pri odraslih bolnikih s HS ter verjetnosti, da so potek bolezni, patofiziologija in učinek zdravila bistveno podobni kot pri odraslih bolniki, pri enaki ravni izpostavljenosti.