natgillin/translations-raw huggingface dataset:
The safety and efficacy of adalimumab was assessed in an open-label, multicenter study in 32 children (2 - < 4 years old or aged 4 and above weighing < 15 kg) with moderately to severely active polyarticular JIA.
Varnost in učinkovitost adalimumaba so ocenili v odprti, multicentrični študiji pri 32 otrocih (starih od 2 do < 4 leta ali starih 4 leta ali več in s telesno maso < 15 kg) z zmernim do zelo aktivnim poliartikularnim JIA.
Demyelinating disease
Demielinizirajoča bolezen
In an exploratory clinical trial evaluating the use of another TNF-antagonist, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
V eksplorativnem kliničnem preskušanju drugega antagonista TNF, infliksimaba, pri bolnikih z zmerno do hudo kronično obstruktivno pljučno boleznijo (KOPB), so med prejemniki infliksimaba zabeleţili več malignomov, večinoma pljuč ali glave in vratu, kot med primerjalnimi bolniki.
Kromeya dose for patients with polyarticular juvenile idiopathic arthrtis
Odmerjanje zdravila Kromeya pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom
pen containing a pre-filled syringe (type I glass) with a 29G Thin-Wall, ½ inch needle with latex-free needle cap and a plunger stopper (synthetic rubber).
peresniku vsebuje napolnjeno injekcijsko brizgo (steklo tipa I), z iglo (29G s tanko steno, 12,7 mm) s pokrovčkom za iglo, ki ne vsebuje lateksa, in z batno zaporko (sintetična guma).
The incidence of serious infections was 0.04 per patient year in adalimumab treated patients and 0.03 per patient year in placebo and active control−treated patients.
Incidenca resnih okuţb je bila 0,04 na bolnikov-let med bolniki, ki so dobivali adalimumab, in 0,03 na bolnikov-let med bolniki, ki so dobivali placebo oziroma kontrolno učinkovino.
P=0.083, adalimumab 0.8 mg/kg versus MTX
P = 0,083, adalimumab 0,8 mg/kg v primerjavi z MTX
Overall responses were generally better and, fewer patients developed antibodies when treated with the combination of adalimumab and MTX compared to adalimumab alone.
Celotni odzivi so bili med zdravljenjem s kombinacijo adalimumaba in metotreksata na splošno boljši in pri manj bolnikih so se pojavila protitelesa kot med zdravljenjem z adalimumabom samo.
In RA study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for adalimumab/methotrexate combination therapy versus methotrexate monotherapy and adalimumab monotherapy at week 52, which was maintained through week 104.
V študiji revmatoidnega artritisa V sta se indeks invalidnosti HAQ in telesna komponenta SF 36 ob kombinirani terapiji z adalimumabom in metotreksatom po 52 tednih izboljšala bolj (p < 0,001) kot ob monoterapiji z metotreksatom ali ob monoterapiji z adalimumabom; to se je ohranilo do 104. tedna.
• 160 mg at week 0 and 80 mg at week 2
• 160 mg v 0. tednu in 80 mg v 2. tednu
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
• aksialni spondiloartritis brez radiografskega dokaza za ankilozirajoči spondilitis,
Kromeya is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Zdravilo Kromeya je indicirano za zdravljenje zmerno do hudo aktivne Crohnove bolezni pri pediatričnih bolnikih (od 6. leta starosti), ki se ne odzovejo zadovoljivo na konvencionalno zdravljenje, vključno s primarno prehransko terapijo in kortikosteroidom in/ali imunomodulatorjem, ali pri tistih, ki imajo intoleranco ali kontraindikacije za tako zdravljenje.
• If your child is about to have surgery or dental procedures tell your doctor that he/she is taking Kromeya.
• Če bo vaš otrok imel kirurški poseg ali poseg na zobeh, povejte svojemu zdravniku, da jemlje zdravilo Kromeya.
The recommended Kromeya induction dose regimen for adult patients with moderately to severely active Crohn's disease is 80 mg at week 0 followed by 40 mg at week 2.
Priporočena shema odmerjanja zdravila Kromeya med indukcijo je pri odraslih bolnikih z zmerno do hudo, aktivno Crohnovo boleznijo 80 mg 0. teden in nato 40 mg 2. teden.
Table 18 Ps Study II (CHAMPION) efficacy results at 16 weeks
Preglednica 18: Študija pri psoriazi II (CHAMPION) Rezultati učinkovitosti po 16 tednih
Paediatric Crohn's disease Age or body weight
Pediatrična Crohnova bolezen Starost ali telesna masa
The mean trough concentrations were maintained in patients who continued to receive adalimumab treatment eow for 52 weeks.
Povprečne najmanjše koncentracije so se pri bolnikih, ki so 52 tednov še naprej prejemali zdravljenje z adalimumabom vsak drugi teden, ohranile.
Travel/recurrent infection
Potovanja/ponavljajoče okuţbe
Table 15 Ps study II (CHAMPION) efficacy results at 16 weeks
Preglednica 15: Študija pri psoriazi II (CHAMPION) Rezultati učinkovitosti po 16 tednih
In Psoriasis Studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at week 16 (see Tables 14 and 15).
V študijah pri psoriazi I in II je bil primarna končna točka deleţ bolnikov, ki so od izhodišča do 16. tedna dosegli PASI 75 (glejte preglednici 14 in 15).
Each box of Kromeya pre-filled syringe comes with two or six syringes.
V vsaki škatli zdravila Kromeya napolnjene injekcijske brizge sta dve ali šest injekcijskih brizg.
Serious infections including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving adalimumab.
Pri bolnikih, ki so dobivali adalimumab, so bile opisane resne okuţbe, vključno s sepso, zaradi bakterijskih, mikobakterijskih, invazivnih glivičnih, parazitskih, virusnih in drugih oportunističnih okuţb, npr. listerioza, legioneloza in pnevmocistična okuţba.
If you develop a fever that does not go away, or you bruise or bleed very easily or look very pale, call your doctor right away.
Če dobite zvišano telesno temperaturo, ki ne mine ali če se vam pojavljajo podplutbe, zlahka zakrvavite ali ste zelo bledi, se takoj posvetujte s svojim zdravnikom.
7.1 Throw away your used pre-filled pen in a sharps disposal container right away after use (Figure S).
7.1 Uporabljen injekcijski peresnik takoj po uporabi zavrzite v zbiralnik za ostre predmete (Slika S).
Maintenance of remission and response rates are presented in Table 22.
Vzdrţevanje remisije in deleţe odziva prikazuje preglednica 22.
In CD study III, 854 patients received open-label 80 mg at week 0 and 40 mg at week 2.
V tej študiji je 854 bolnikov odprto prejelo 80 mg v 0. tednu in 40 mg v 2. tednu.
Kromeya dose for paediatric patients with Crohn's disease
Odmerjanje zdravila Kromeya pri pediatričnih bolnikih s Crohnovo boleznijo
The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a Physician's Global Assessment (PGA) ≥ 4 or > 20% BSA involvement or > 10% BSA involvement with very thick lesions or Psoriasis Area and Severity Index (PASI) ≥ 20 or ≥ 10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy.
Učinkovitost adalimumaba je bila ocenjena v randomizirani, dvojno slepi, kontrolirani študiji, v katero je bilo vključenih 114 pediatričnih bolnikov od 4. leta starosti, s hudo kronično psoriazo v plakih (definirano z zdravnikovo globalno oceno (PGA - Physician's Global Assessment) ≥ 4 ali 20 % zajete telesne površine ali > 10 % zajete telesne površine z zelo grobimi lezijami ali indeksom obseţnosti in izrazitosti psoriaze (PASI - Psoriasis Area and Severity Index) ≥ 20 ali ≥ 10 s klinično pomembnim zajetjem obraza, genitalij ali dlani/stopal), ki ni bila ustrezno nadzorovana s topikalnim zdravljenjem in helioterapijo ali fototerapijo.
Patients received adalimumab 0.8 mg/kg eow (up to 40 mg), 0.4 mg/kg eow (up to 20 mg), or methotrexate 0.1 - 0.4 mg/kg weekly (up to 25 mg).
Bolniki so prejemali adalimumab v odmerkih 0,8 mg/kg vsak drugi teden (do največ 40 mg), 0,4 mg/kg vsak drugi teden (do največ 20 mg) ali 0,1 - 0,4 mg/kg metotreksata (MTX) na teden (do največ 25 mg).
*** p < 0.001 for all comparisons between adalimumab and placebo * p < 0.05 for all comparisons between adalimumab and placebo N/A not applicable
*** p < 0,001 za vse primerjave med adalimumabom in placebom *p < 0,05 za vse primerjave med adalimumabom in placebom np ne pride v poštev
1.2 Leave the kit at room temperature for at least 30 minutes to allow the medicine to warm up.
1.2 Komplet z vialo pustite na sobni temperaturi 30 minut, da se zdravilo ogreje.
If your child has mild heart failure and is being treated with Kromeya, his/her heart failure status must be closely monitored by your doctor.
Če ima vaš otrok blago srčno popuščanje in se zdravi z zdravilom Kromeya, mora zdravnik natančno nadzorovati stanje srčnega popuščanja pri vašem otroku.
6.2 Pinch the skin
6.2 Naredite koţno gubo
Kromeya is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
Zdravilo Kromeya je indicirano za zdravljenje hude psoriaze v plakih pri otrocih in mladostnikih od 4. leta starosti, ki so se neustrezno odzvali na ali niso ustrezni kandidati za topikalno zdravljenje in fototerapije.
Warning: Do not touch the top of the vial after cleaning.
Opozorilo: Ko ste zgornji del viale očistili, se ga ne smete več dotikati.
In Study nr-axSpA I, adalimumab 40 mg every other week was assessed in 185 patients in one randomised, 12 week double-blind, placebo-controlled study in patients with active nr-axSpA (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥ 1 NSAIDs, or a contraindication for NSAIDs.
Uporabo adalimumaba 40 mg vsak drugi teden so proučili v randomizirani, 12 tednov trajajoči, dvojno slepi, s placebom kontrolirani študiji nr-axSpA I pri 185 bolnikih z aktivnim nr-axSpA (srednja vrednost aktivnosti bolezni [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] je bila 6,4 pri bolnikih zdravljenih z adalimumabom in 6,5 pri bolnikih na placebu), ki so nezadostno reagirali na ali niso prenašali vsaj enega NSAID ali s kontraindikacijo za NSAID.
These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients.
Ta preskušanja so vključevala bolnike z revmatoidnim artritisom (tako tiste, ki so imeli bolezen kratek čas, kot tiste, ki so jo imeli ţe dolgo), juvenilnim idiopatskim artritisom (poliartikularnim juvenilnim idiopatskim artritisom in artritisom, povezanim z entezitisom), aksialnim spondiloartritisom (ankilozirajočim spondilitisom in aksialnim spondiloartritisom brez radiografskega dokaza za AS), psoriatičnim artritisom, Crohnovo boleznijo, ulceroznim kolitisom, psoriazo, hidradenitis suppurativa in uveitisom.
• Only use Kromeya pre-filled syringe if your healthcare professional has trained you on how to use the pre-filled syringe correctly.
• Zdravilo Kromeya napolnjena injekcijska brizga lahko uporabljate le, če vas je zdravstveni delavec naučil, kako pravilno uporabljati napolnjeno injekcijsko brizgo.
• neuropathy (nerve damage);
• nevropatija (poškodbe ţivčevja);
Plaque psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales.
Luskavica v plakih je bolezen koţe, pri kateri nastajajo rdeče, kosmičaste, krastave lise na koţi, pokrite s srebrnimi luskami.
Hepatosplenic T-cell lymphoma Merkel cell carcinoma (neuroendocrine carcinoma of the skin)
redki levkemija neznana pogostnost hepatosplenični T-celični limfom karcinom Merklovih celic (nevroendokrini karcinom koţe)
• skin infections (including cellulitis and shingles);
• okuţbe koţe (vključno s celulitisom in pasovcem);
Enthesitis-related arthritis Age or body weight
Z artritisom povezan entezitis Starost ali telesna masa
It is important that you tell your baby's doctors and other health care professionals about your Kromeya use during your pregnancy so they can decide when your baby should receive any vaccine.
Zato je pomembno, da obvestite zdravnika vašega otroka in druge zdravstvene delavce, da ste med nosečnostjo prejemali zdravilo Kromeya, da se lahko odločijo, kdaj bo vaš otrok lahko prejel katerokoli cepivo.
Doses of 20 or 40 mg of adalimumab were given by subcutaneous injection every other week with placebo on alternative weeks or every week for 26 weeks; placebo was given every week for the same duration.
Bolniki so 26 tednov dobivali odmerka 20 ali 40 mg adalimumaba v subkutani injekciji vsak drugi teden s placebom vsak vmesni teden ali vsak teden; placebo so dobivali vsak teden enako dolgo.
If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately.
Če se simptomi srčnega popuščanja (npr. teţko dihanje ali otekanje nog) pojavijo na novo ali se poslabšajo, se morate takoj obrniti na svojega zdravnika.
What you need to know before you use Kromeya
Kaj morate vedeti, preden boste uporabili zdravilo Kromeya
- Your doctor will also give you a patient reminder card, which contains important safety information that you need to be aware of before your child is given Kromeya and during treatment with Kromeya.
Ta vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni, preden vaš otrok prejme zdravilo Kromeya in med zdravljenjem z njim.
MTX N=110 n (%)
metotreksat n = 110 n (%)
Plaque psoriasis is an inflammatory skin condition that causes red, flaky, crusty patches of skin covered with silvery scales.
Luskavica v plakih je vnetna bolezen koţe, pri kateri nastajajo rdeče, kosmičaste, krastave lise na koţi, pokrite s srebrnimi luskami.
6.4 If there is blood or liquid on the skin, treat the injection site by gently pressing a cotton ball or gauze on the site (Figure R).
6.4 Če je na mestu injiciranja kri ali tekočina, nanj neţno pritisnite s kosem vate ali gazo (Slika R).
This includes any possible side effects not listed in this leaflet.
Posvetujte se tudi, če opazite neţelene učinke, ki niso navedeni v tem navodilu.
On the basis of clinical trial data in patients with JIA (pJIA and ERA), an exposure-response relationship was established between plasma concentrations and PedACR 50 response.
Na podlagi podatkov iz kliničnih preskušanj pri bolnikih z juvenilnim idiopatskim artritisom (JIA) (poliartikularnim idiopatskim artritisom (pJIA) in z artritisom, povezanim z entezitisom (ERA)) je bilo dokazano razmerje med izpostavljenostjo in odzivom med plazemskimi koncentracijami in PedACR (PedACR - American College of Rheumatology pediatric) odzivom.
Assessment of SpondyloArthritis international Society Baseline is defined as open label baseline when patients have active disease.
c neaktivna bolezen Delni zagon bolezni d a ocena spondiloartritičnega mednarodnega zdruţenja (Assessment of Spondyloarthritis International Society b izhodišče je določeno kot izhodišče odprte faze, ko imajo bolniki aktivno bolezen c ocena bolezenske aktivnosti ankilozirajočega spondilitisa (Ankylosing Spondylitis Disease Activity Score)
p-value a p-value b p-value c
vrednost a vrednost b vrednost c
Kromeya is indicated for the treatment of Crohn's disease in children aged 6 to 17 years.
Zdravilo Kromeya je namenjeno za zdravljenje Crohnove bolezni pri otrocih, starih 6 do 17 let.
• Kromeya is a pre-filled syringe for single use only.
• Zdravilo Kromeya je napolnjena injekcijska brizga za zgolj enkratno uporabo.
Non-infectious uveitis Age or body weight
Neinfekcijski uveitis Starost ali telesna masa
• Kromeya Vial Kit is for single use only.
• Zdravilo Kromeya komplet z vialo je namenjen le enkratni uporabi.
• The Kromeya pre-filled pen comes as a ready to use single-use pre-filled pen to give a full dose of adalimumab.
• Zdravilo Kromeya je napolnjen injekcijski peresnik, ki je pripravljen za uporabo in omogoča dajanje polnega odmerka adalimumaba.
• haematoma (a solid swelling with clotted blood);
• hematom (trda oteklina s strjeno krvjo);
After week 2, patients in both adalimumab arms received 40 mg eow.
2. tednu so bolniki v obeh krakih z adalimumabom prejemali 40 mg vsak drugi teden.
Each box contains 1 vial, 1 sterile injection syringe, 1 sterile needle, 1 vial adaptor and 2 alcohol pads.
1 vialo, 1 sterilno injekcijsko brizgo 1 sterilno iglo, 1 adapter za vialo in 2 alkoholna zloţenca.
Very common (may affect more than 1 in 10 people)
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
4.3 Pull the needle packaging off.
4.3 Odstranite ovojnino z injekcijske igle.
88 and 189 patients, respectively, continued to be in clinical remission.
88 bolnikov iz študije Crohnove bolezni I in 189 bolnikov iz študij Crohnove bolezni II in III je bilo še naprej v klinični remisiji.
• Certain vaccines contain living but weakened forms of disease-causing bacteria or viruses and should not be given during treatment with Kromeya in case they cause infections.
• Določena cepiva lahko vsebujejo ţive ampak oslabljene oblike povzročitelja bolezni (bakterije ali viruse), zato se jih v primerih, ko lahko povzročijo okuţbo, ne sme dajati med zdravljenjem z zdravilom Kromeya.
Table 18 Paediatric CD study PCDAI clinical remission and response
Preglednica 18 Študija Crohnove bolezni pri pediatričnih bolnikih PCDAI klinična remisija in odziv Standardni odmerek
In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see Table 12).
V študiji revmatoidnega artritisa V so strukturno okvaro sklepov ocenili rentgenografsko in jo izrazili kot razliko v modificirani celotni Sharpovi oceni (glejte preglednico 12).
• If your child experiences allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Kromeya and contact your doctor immediately since, in rare cases, these reactions can be life threatening.
• Če vaš otrok doţivi alergijske reakcije s simptomi, kot so tiščanje v prsih, piskajoče dihanje, omotica, otekanje ali izpuščaj, zdravila Kromeya ne injicirajte več in se takoj posvetujte s svojim zdravnikom, saj so v redkih primerih te reakcije lahko ţivljenje ogroţajoče.
Once removed from the refrigerator for room temperature storage, your pre-filled syringe must be used within 14 days or discarded, even if it is later returned to the refrigerator.
Ko ga enkrat, namesto v hladilniku, shranjujete pri sobni temperaturi, morate napolnjen injekcijski peresnik porabiti v 14 dneh ali pa zavreči, tudi če ga vrnete v hladilnik.
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Poliartikularni juvenilni idiopatski artritis in artritis, povezan z entezitisom
20 mg every other week
20 mg vsak drugi teden
At week 16, more patients randomised to adalimmab 0.8 mg/kg had positive efficacy responses (e.g. PASI 75) than those randomised to 0.4 mg/kg eow or MTX.
V 16. tednu se je več bolnikov, ki so bili randomizirani na adalimumab 0,8 mg/kg, pozitivno odzvalo v smislu učinkovitosti (npr. PASI 75) kot tistih, ki so bili randomizirani na odmerek 0,4 mg/kg vsak drugi teden ali metotreksat.
***, ** Statistically significant at p < 0.001 and < 0.01, respectively, for all comparisons between adalimumab and placebo.
***, ** Statistično značilno s p < 0,001 in < 0,01 (v tem zaporedju) za vse primerjave med adalimumabom in placebom.
The reported rates for non-melanoma skin cancers and lymphomas are approximately 0.2 and 0.3 per 1,000 patient treatment years, respectively (see section 4.4).
Ugotovljeni deleţ nemelanomskih rakov je pribliţno 0,2 na 1000 bolnikov-let zdravljenja in limfomov pribliţno 0,3 na 1000 bolnikov-let zdravljenja(glejte poglavje 4.4).
Time to treatment failure at or after week 2 in study UV II Primary analysis (ITT)
Čas do neuspeha zdravljenja v ali po 2. tednu v študiji UV II Primarna analiza (ITT)
• If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Kromeya and contact your doctor immediately since, in rare cases, these reactions can be life threatening.
• Če imate alergijsko reakcijo s simptomi, kot so tiščanje v prsih, piskajoče dihanje, omotica, otekanje ali izpuščaj, zdravila Kromeya ne injicirajte več in se takoj posvetujte s svojim zdravnikom, saj so v redkih primerih te reakcije lahko ţivljenje ogroţajoče.
Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with adalimumab Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with adalimumab.
Kljub profilaktičnemu zdravljenju za tuberkulozo, so se pri bolnikih, zdravljenih z adalimumabom, pojavili primeri reaktivacije tuberkuloze.
• difficulty sleeping;
• oteţkočeno spanje;
The recommended dose of Kromeya for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Priporočeni odmerek zdravila Kromeya za odrasle bolnike z revmatoidnim artritisom je 40 mg adalimumaba vsak drugi teden v enkratnem odmerku v subkutani injekciji.
Warning: Do not warm the kit any other way, such as in a microwave, hot water, or direct sunlight.
Opozorilo: Kompleta ne smete ogreti na noben drug način, na primer v mikrovalovni pečici, vroči vodi ali na neposredni sončni svetlobi.
PGA: Clear/minimal c a
PGA: čisto/minimalno c a
Patients were randomised to receive either 24 mg/m2 body surface area (BSA) of adalimumab up to a maximum of 40 mg, or placebo every other week for 12 weeks.
Bolniki so bili randomizirani za prejemanje bodisi 24 mg/m telesne površine adalimumaba do največjega posamičnega odmerka 40 mg ali placebo vsak drugi teden, 12 tednov.
At week 4, subjects were randomised 1:1 based on their body weight at the time to either the Low Dose or Standard Dose maintenance regimens as shown in Table 17.
V 4. tednu so bili bolniki glede na njihovo telesno maso v tem času randomizirani v razmerju1:1 bodisi v vzdrţevalni reţim z majhnim odmerkom ali vzdrţevalni reţim s standardnim odmerkom, kot kaţe preglednica 17.
Among those, 48 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less.
Med temi bolniki jih 48 ni kazalo napredovanja strukturne prizadetosti izraţene s spremembo srednje celotne Sharpove ocene 0,5 ali manj od začetka študije.
Table 24 Paediatric CD study PCDAI clinical remission and response
Preglednica 24 Študija Crohnove bolezni pri pediatričnih bolnikih PCDAI klinična remisija in odziv Standardni odmerek
Sustained response
Ohranjen odziv
Among those, 86 patients (75.4%) had ACR 20 responses; 72 patients (63.2%) had ACR 50 responses; and 41 patients (36%) had ACR 70 responses.
Med temi je 86 bolnikov (75,4 %) imelo odziv 20 po ACR; 72 bolnikov (63,2 %) je imelo odziv 50 po ACR; in 41 bolnikov (36 %) je imelo odziv 70 po ACR.
Warning: Do not throw away the syringe in your household trash.
Opozorilo: Injekcijske brizge ne zavrzite med gospodinjske odpadke.
Rare (may affect up to 1 in 1,000 people)
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
• Do not insert your fingers into the opening of the clear needle guard.
• Ne dajajte prstov v reţo na prozornem varovalu za injekcijsko iglo.