natgillin/translations-raw huggingface dataset:
CD study I and CD study II induction of remission and response rates are presented in Table 21.
Indukcijo remisije in deleţe odziva v študiji pri Crohnovi bolezni I in študiji pri Crohnovi bolezni II prikazuje preglednica 21.
Kromeya 40 mg/0.8 mL solution for injection for paediatric use adalimumab
Kromeya 40 mg/0,8 ml raztopina za injiciranje za pediatrično uporabo adalimumab
Warning: Do not reuse a syringe in case of partial injection.
Opozorilo: Če injicirate le del odmerka, ne smete ponovno uporabiti injekcijske brizge.
There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis.
Psoriatični artritis in aksialni spondiloartritis, vključno z ankiloznim spondilitisom Uporaba adalimumaba pri pediatrični populaciji za indikaciji ankilozni spodilitis in psoriatični artritis ni primerna.
• Store the pre-filled syringe in its original box to protect it from light.
• Napolnjen injekcijski peresnik shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
The recommended dose of Kromeya for paediatric patients with uveitis from 2 years of age is based on body weight (Table 5).
Priporočeni odmerek zdravila Kromeya pri pediatričnih bolnikih z uveitisom, starih 2 leti ali več, temelji na telesni masi (preglednica 5).
- If you get any side effects, talk to your doctor or pharmacist.
- Če opazite kateri koli neţeleni učinek, se posvetujte z zdravnikom ali farmacevtom.
The recommended dose of Kromeya for patients with enthesitis-related arthritis from 6 years of age is based on body weight (Table 2).
Priporočeni odmerek zdravila Kromeya pri bolnikih z artritisom, povezanim z entezitisom, starih 6 let in več, temelji na telesni masi (preglednica 2).
Pack sizes of: - 2 pre-filled syringes, with 2 alcohol pads - 6 pre-filled syringes, with 6 alcohol pads.
Velikost pakiranj: - 2 napolnjena injekcijska peresnika z 2 alkoholnima zloţencema - 6 napolnjenih injekcijskih peresnikov s 6 alkoholnimi zloţenci
Step 6 Give Injection
6. korak Injicirajte zdravilo
Erosion score
Ocena erozij Ocena ZSŠ
The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥ 10% BSA involvement and PASI ≥ 12 or ≥ 10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Varnost in učinkovitost adalimumaba so raziskali v randomiziranih, dvojno slepih študijah pri odraslih bolnikih s kronično psoriazo v plakih (zajete ≥ 10 % telesne površine ter indeksom obseţnosti in izrazitosti psoriaze PASI ≥ 12 ali ≥ 10), ki so bili kandidati za sistemsko zdravljenje ali fototerapijo.
• Keep Kromeya pre-filled syringe and the sharps disposal container out of reach and sight of children.
• Zdravilo Kromeya napolnjena injekcijsko brizgo in zbiralnik za ostre predmete shranjujte nedosegljivo otrokom.
Possible side effects
Neţeleni učinki
Concomitant administration of adalimumab with other biologic DMARDs (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions.
Sočasna uporaba adalimumaba z drugimi biološkimi DMARDs (tj.anakinra in abacept) ali z drugimi antagonisti TNF ni priporočljiva zaradi moţnega povečanega tveganja za okuţbe, vključno z resnimi okuţbami, in drugih potencialnih farmakoloških interakcij (glejte poglavje 4.5).
In patients with polyarticular JIA who were 2 to <4 years old or aged 4 and above weighing <15 kg dosed with adalimumab 24 mg/m2 , the mean trough steady-state serum adalimumab concentrations was 6.0 ± 6.1 µg/mL (101% CV) for adalimumab without concomitant methotrexate and 7.9 ± 5.6 µg/mL (71.2% CV) with concomitant methotrexate.
< 15 kg, ki so prejemali adalimumab v odmerku 24 mg/m2, je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja 6,0 ± 6,1 µg/ml (KV 101 %) med uporabo adalimumaba brez metotreksata in 7,9 ± 5,6 µg/ml (KV 71,2 %) med sočasno uporabo metotreksata.
Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg
Otroci in mladostniki, starejši od 2 let, ki tehtajo od 10 kg do manj kot 30 kg
4.5 Place the syringe on a clean, flat surface.
4.5 Injekcijsko brizgo poloţite na čisto, ravno površino.
Each vial contains 40 mg of adalimumab in 0.8 ml of solution.
Ena viala vsebuje 40 mg adalimumaba in 0,8 ml raztopine.
If these medicines do not work well enough, you will be given Kromeya to reduce the signs and symptoms of your disease.
Če ta zdravila ne bodo dovolj delovala, boste dobili zdravilo Kromeya za zmanjšanje znakov in simptomov vaše bolezni.
Table 12 Radiographic mean changes at week 52 in RA study V
Preglednica 12: Povprečne rentgenografske spremembe po 52 tednih študije revmatoidnega artritisa V
A statistically significant decrease in fatigue as measured by functional assessment of chronic illness therapy (FACIT) scores was seen in all three studies in which it was assessed (RA studies I, III, IV).
V vseh treh študijah (študije revmatoidnega artritisa I, III in IV), v katerih so ocenjevali utrujenost s funkcijsko oceno terapije kronične bolezni (functional assessment of chronic illness therapy (FACIT)), so ugotovili statistično značilno zmanjšanje utrujenosti.
Kromeya is contraindicated in moderate to severe heart failure (see section 4.3).
Pri bolnikih z zmernim do hudim srčnim popuščanjem je zdravilo Kromeya kontraindicirano (glejte poglavje 4.3).
Children and adolescents from 2 years of age weighing less than 30 kg
Otroci in mladostniki, starejši od 2 let, ki tehtajo manj kot 30 kg
If this dose does not work well enough, your child's doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Če ta odmerek ne bo deloval dovolj dobro, lahko otrokov zdravnik odmerek poveča na 40 mg vsak teden ali na 80 mg vsak drugi teden.
Warning: Do not remove the needle cap while allowing syringe to reach room temperature.
Opozorilo: Medtem ko čakate, da se injekcijska brizga ogreje na sobno temperaturo, ne smete odstraniti pokrovčka na injekcijski igli.
Kromeya 40 mg solution for injection (injection) in pre-filled syringe is supplied as a sterile 0.8 mL clear, colourless solution of 40 mg adalimumab.
Zdravilo Kromeya 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku je na voljo kot 0,8 ml sterilna, bistra, brezbarvna raztopina z 40 mg adalimumaba.
If so, throw away the pre-filled pen in a sharps disposal container and contact your healthcare professional or pharmacist.
V tem primeru injekcijski peresnik zavrzite v zbiralnik za ostre predmete in se obrnite na svojega zdravstvenega delavca ali farmacevta.
Vertigo and visual impairment may occur following administration of Kromeya (see section 4.8).
Po dajanju zdravila Kromeya se lahko pojavita vrtoglavica in poslabšanje vida (glejte poglavje 4.8).
• muscle spasms;
• okuţbe sečil;
• reproductive tract infections;
• okuţbe reproduktivnih organov;
Kromeya therapy should not be continued in patients failing to respond within this time period.
Pri bolnikih, ki se v tem času ne odzovejo na zdravljenje z zdravilom Kromeya, zdravljenja ni priporočljivo nadaljevati.
Table 20 Induction of clinical remission and response (percent of patients)
Preglednica 20 Indukcija klinične remisije in odziv (Odstotek bolnikov)
• pulmonary fibrosis (scarring of the lung);
• pljučna fibroza (brazgotinjenje pljuč);
• It is important to tell your doctor if your child gets symptoms of infections, such as fever, wounds, feeling tired or dental problems.
• Pomembno je, da poveste zdravniku, če vaš otrok dobi znake okuţbe, kot so zvišana telesna temperatura, rane, utrujenost ali problemi z zobmi.
The safety guard will slide down and lock into place to protect you from the needle (Figure Q).
Varovalo se bo spustilo navzdol in ostalo na mestu, da se ne bi poškodovali z iglo.
Week 12 Week 24 ASAS 70 Week 2
12. teden 4 % 24. teden 6 %
Back view
Zadnja stran
≥ 40 kg • 80 mg at week 0 and 40 mg at week 2
< 40 kg • 40 mg v 0. tednu in 20 mg v 2. tednu
Kromeya dose for paediatric patients with uveitis
Odmerjanje zdravila Kromeya pri pediatričnih bolnikih z uveitisom
Pack sizes of: - 2 pre-filled pens, with 2 alcohol pads - 6 pre-filled pens, with 6 alcohol pads.
Velikost pakiranj: - 2 napolnjeni injekcijski brizgi z 2 alkoholnima zloţencema - 6 napolnjenih injekcijskih brizg s 6 alkoholnimi zloţenci
• Top of the thighs or
• zgornjem delu stegen ali
Tabulated list of adverse reactions
Seznam neţelenih učinkov v preglednici
• polyarticular juvenile idiopathic arthritis
• poliartikularni juvenilni idiopatski artritis
Non-serious allergic reactions associated with adalimumab were uncommon during clinical trials.Reports of serious allergic reactions including anaphylaxis have been received following adalimumab administration.
Po uporabi adalimumaba so prejeli poročila o resnih alergijskih reakcijah, vključno z anafilaksijo.
5.3 Remove the clear needle cap by pulling it straight off and throw it away.
5.3 Odstranite prozoren pokrovček na injekcijski igli in ga zavrzite.
• paediatric plaque psoriasis
• luskavica (psoriaza) v plakih pri pediatričnih bolnikih
This will unlock the injection button (Figure O).
S tem boste odklenili gumb za injiciranje.
In study UC-I, 390 TNF-antagonist naïve patients were randomised to receive either placebo at weeks 0 and 2, 160 mg adalimumab at week 0 followed by 80 mg at week 2, or 80 mg adalimumab at week 0 followed by 40 mg at week 2.
V študiji UC-I so 390 bolnikov, ki še niso prejemali antagonista TNF, randomizirali bodisi na placebo in 2. teden, na adalimumab 0. teden in 80 mg 2. teden, ali na 80 mg 0. teden in 40 mg 2. teden.
• any issue you had
• kakršnihkoli teţavah,
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,
Zdravilo Kromeya je namenjeno za zdravljenje naslednjih vnetnih bolezni: - revmatoidni artritis, - poliartikularni juvenilni idiopatski artritis, - artritis, povezan z entezitisom, - ankilozirajoči spondilitis, - aksialni spondiloartritis brez radiografskega dokaza za ankilozirajoči spondilitis, - psoriatični artritis, - luskavica (psoriaza), - Crohnova bolezen, - ulcerozni kolitis in - neinfekcijski uveitis.
Your doctor may prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual dose.
Zdravnik lahko predpiše začetni odmerek 40 mg, ki se ga lahko uporabi en teden pred začetkom zdravljenja z običajnim odmerkom.
Table 20: Paediatric plaque psoriasis efficacy results at 16 weeks MTX
Preglednica 20: Rezultati učinkovitosti v 16. tednu pri pediatričnih bolnikih s psoriazo v plakih
If these medicines do not work well enough, your child will be given Kromeya to reduce the signs and symptoms of his/her disease.
Če ta zdravila ne delujejo dovolj dobro, bo vaš otrok dobil zdravilo Kromeya za zmanjšanje znakov in simptomov Crohnove bolezni.
Kromeya 40 mg solution for injection in pre-filled syringe adalimumab
Kromeya 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku adalimumab
Children and adolescents from 2 years of age weighing 30 kg or more
Otroci in mladostniki, starejši od 2 let, ki tehtajo 30 kg ali več
RA Study III a**
Študija revmatoidnega artritisa a**
• pull the pre-filled pen straight up and out of the packaging (Figure D).
• injekcijski peresnik potegnite navzgor iz škatle (Slika D).
Step 3 Check the Syringe
3. korak Preglejte injekcijsko brizgo
• Store the pre-filled pen in its original box to protect it from light.
• Napolnjeno brizgo shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
PsA study II with 12 -week duration, treated 100 patients who had an inadequate response to DMARD therapy.
V njej so zdravili 100 bolnikov, ki se niso ustrezno odzvali na imunomodulirajočo terapijo.
5.1 Wipe the skin of your injection site with an alcohol pad to clean it (Figure K).
5.1 Koţo na mestu injiciranja obrišite z zloţencem, prepojenim z alkoholom, da jo očistite.
Kromeya is available as a vial, a pre-filled syringe and a pre-filled pen.
Zdravilo Kromeya je na voljo v viali, napolnjeni injekcijski brizgi in napolnjenem injekcijskem peresniku.
Your child's doctor may prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual dose.
Otrokov zdravnik lahko predpiše začetni odmerek 40 mg, ki se ga lahko uporabi en teden pred začetkom zdravljenja z običajnim odmerkom.
Note: P = Placebo (Number at Risk); A = Adalimumab (Number at Risk).
Opomba: P = placebo (število rizičnih preiskovancev); A = Adalimumab (število rizičnih preiskovancev).
Adalimumab/methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and adalimumab monotherapy (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
Za doseganje nizkega stanja bolezni pri bolnikih z nedavno diagnosticiranim zmernim do hudim revmatoidnim artritisom je bila kombinirana terapija z adalimumabom in metotreksatom klinično in statistično boljša od monoterapije z metotreksatom (p < 0,001) in monoterapije z adalimumabom (p < 0,001).
Read carefully these entire instructions before using your Kromeya pre-filled syringe.
Pred uporabo zdravila Kromeya napolnjena injekcijska brizga natančno preberite celotno navodilo.
Week 12 Week 24 ASAS 50 Week 2
2. teden 12. teden 24. teden ASAS 50 2. teden 12. teden 24. teden ASAS 70 2. teden 12. teden 24. teden
• facial oedema (swelling);
• edem obraza (oteklina);
Table 25 Paediatric CD study Discontinuation of corticosteroids or immunomodulators and fistula remission
Preglednica 25 Študija Crohnove bolezni pri pediatričnih bolnikih Prenehanje zdravljenja s kortikosteroidi ali imunomodulatorji in remisija fistule Standardni odmerek 40/20 mg vsak drugi teden
If this dose does not work well enough, your doctor may increase the dose frequency to 40 mg every week or 80 mg every other week.
Če ta odmerek ne bo deloval dovolj dobro, lahko zdravnik poveča odmerek na 40 mg vsak teden ali na 80 mg vsak drugi teden.
Discontinuation of Kromeya therapy should be considered in patients with confirmed significant haematologic abnormalities.
Pri bolnikih s potrjenimi pomembnimi hematološkimi nepravilnostmi je treba razmisliti o prekinitvi terapije z zdravilom Kromeya.
RA study III a**
Študija revmatoidnega artritisa III a**
Table 21 Induction of clinical remission and response (percent of patients)
Preglednica 21: Indukcija klinične remisije in odziva (odstotek bolnikov)
ACR 20 Week 12 Week 24
> 32 tednov 20 tednov > 32 tednov
• Only use Kromeya Vial Kit if your healthcare professional has trained you how to use it correctly.
• Zdravilo Kromeya komplet z vialo lahko uporabljate le, če vas je zdravstveni delavec naučil,
RA Study II a**
Študija revmatoidnega artritisa II a**
3.2 Check the label to make sure that:
3.2 Preverite nalepko, ali:
Kromeya is administered via subcutaneous injection.
Zdravilo Kromeya se odmerja v obliki subkutane injekcije.
Opportunistic infections, including invasive fungal infections have been observed in patients receiving adalimumab.
Pri bolnikih, ki so dobivali adalimumab, so opaţali oportunistične okuţbe, vključno z invazivnimi glivičnimi okuţbami.
Transparent syringe housing
PODATKI NA ZUNANJI OVOJNINI
Low dose 20/10 mg eow p value
Nizek odmerek 20/10 mg vsak drugi teden p vrednost
Check with your doctor before your child receives any vaccines.
Preden vaš otrok opravi kakršno koli cepljenje, se posvetujte z zdravnikom.
2.5 Wipe the entire vial top with an alcohol pad and throw the pad away.
2.5 Očistite površino pod pokrovčkom z zloţencem, prepojenim z alkoholom, ki ga nato zavrţete.
Phase
Masa
Adalimumab 40 mg eow N=109
Adalimumab 40 mg vsak drugi teden N = 109
In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), 80 mg at week 2 (given as two 40 mg injections in one day), can be used with the awareness that the risk for adverse events is higher during induction.
Če je potreben hitrejši odziv na zdravljenje, lahko uporabite shemo 160 mg 0. teden (aplicirano kot štiri 40 mg injekcije v enem dnevu ali dve 40 mg injekciji na dan dva dni zapored) in 80 mg 2. teden (aplicirano kot dve 40 mg injekcija v enem dnevu).
Your child's doctor may prescribe an initial dose of 80 mg which may be administered one week prior to the start of the usual dose.
Otrokov zdravnik lahko predpiše začetni odmerek 80 mg, ki se ga uporabi en teden pred začetkom zdravljenja z običajnim odmerkom.
a p Value b
vrednost p
If you get any side effects, talk to your doctor or pharmacist.
Če opazite katerega koli izmed neţelenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
• Tell your doctor if your child has a history of recurrent infections or other conditions that increase the risk of infections.
• Zdravniku povejte, če je vaš otrok imel v preteklosti ponavljajoče se okuţbe ali druge bolezni,
NA
Po
• Do not shake.
• ne pušča,
Refer to Storage information for -how to store your unused syringe(s).
Za navodila za shranjevanje neuporabljene injekcijske brizge (neuporabljenih injekcijskih brizg) glejte poglavje Navodila za shranjevanje.
Warning: Do not remove the clear needle cap.
Opozorilo: Ne odstranite prozornega pokrovčka na igli.
It is important to tell your doctor if your child gets symptoms such as fever, wounds, feeling tired or dental problems.
Pomembno je, da zdravniku poveste, če vaš otrok doţivi simptome, kot so npr. zvišana telesna temperatura, rane, občutek utrujenosti ali teţave z zobmi.
CD study I: infliximab naive patients
Študija pri Crohnovi bolezni I: Bolniki, ki še niso dobivali infliksimaba
Table 22 Maintenance of clinical remission and response (percent of patients)
Preglednica 22: Vzdrţevanje klinične remisije in odziva (odstotek bolnikov)
Table 13: Paediatric plaque psoriasis efficacy results at 16 weeks MTX
Preglednica 14: Študija pri psoriazi I (REVEAL) Rezultati učinkovitosti po 16 tednih Adalimumab placebo
Warning: Do not touch the vial adapter.
Opozorilo: Nastavka za vialo se ne dotikajte.
Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis studies I − V. In these trials, 11.9% of patients treated with adalimumab and 8.1% of placebo and active control − treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24.
V teh preskušanjih so pozitivne titre protijedrnih protiteles po 24 tednih ugotovili pri 11,9 % prejemnikov adalimumaba in 8,1 % prejemnikov placeba in kontrolne učinkovine, ki so imeli izhodiščno negativne titre teh protiteles.
Ankylosing Spondylitis Disease Activity Score
ASDAS = ocena bolezenske aktivnosti ankilozirajočega spondilitisa (Ankylosing Spondylitis Disease Activity Score)
Children, adolescents and adults from 6 years of age weighing 30 kg or more
Otroci in mladostniki, starejši od 6 let, ki tehtajo 30 kg ali več
6.1 With the other hand, gently pinch a fold of cleaned skin and maintain it.
6.1 Z drugo roko neţno naredite koţno gubo in jo drţite.
• Keep the Kromeya pre-filled pen out of the reach of children.
• Zdravilo Kromeya napolnjen injekcijski peresnik shranjujte nedosegljivo otrokom.
• 80 mg at week 0 and 40 mg at week 2
• 80 mg v 0. tednu in 40 mg v 2. tednu ≥ 40 kg • 80 mg v 0. tednu in 40 mg v 2. tednu
How to store Kromeya
Shranjevanje zdravila Kromeya
Treatment with Kromeya must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Pri bolnikih, ki se jim na novo pojavijo simptomi kongestivnega srčnega popuščanja ali se jim takšni simptomi poslabšajo, je treba zdravljenje z zdravilom Kromeya prekiniti.
Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline PGA score ranged from “moderate” (53% of subjects included) to “severe” (41%) to “very severe” (6%).
V vseh terapevtskih skupinah je bila povprečna izhodiščna ocena PASI 18,9, izhodiščna zdravnikova globalna ocena PGA pa je segala od "zmerne" (53 % vključenih preiskovancev) do "hude" (41 %) in "zelo hude" (6 %).
Paediatric plaque psoriasis Age or body weight
Pediatrična luskavica v plakih Starost ali telesna masa
p-value
P vrednost
• skin cancer;
• koţni rak;
Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab.
Ena 0,8 ml enoodmerna napolnjena injekcijska brizga vsebuje 40 mg adalimumaba.
It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems.
Pomembno je, da zdravniku poveste, če doţivite simptome, kot so npr. zvišana telesna temperatura, rane, občutek utrujenosti ali teţave z zobmi.
Warning: Do not use the syringe if there is a large amount of air in the syringe.
Opozorilo: Če je v injekcijski brizgi večja količina zraka, je ne smete uporabiti.
Kromeya 40 mg solution for injection in pre-filled syringe
Kromeya 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
Idiopathic thrombocytopenic purpura
Adalimumab placebo metotreksat
• If needed, for example when traveling, a single pre-filled syringe can be stored at room temperature for up to 14 days.
• Po potrebi lahko posamezno napolnjeno injekcijsko brizgo shranjujete pri sobni temperaturi do
4.1 Peel open the needle packaging to uncover the yellow syringe connector.
4.1 Odprite ovojnino in jo odstranite z rumenega konektorja za injekcijsko brizgo.
• trouble breathing, swallowing;
• teţave pri dihanju, poţiranju;
Table 19 Paediatric CD study Discontinuation of corticosteroids or immunomodulators and fistula remission
Preglednica 19 Študija Crohnove bolezni pri pediatričnih bolnikih Prenehanje zdravljenja s kortikosteroidi ali imunomodulatorji in remisija fistule Standardni odmerek 40/20 mg vsak drugi teden
Table 21 Maintenance of clinical remission and response (percent of patients)
Preglednica 21 Vzdrţevanje klinične remisije in odziv (Odstotek bolnikov)
• liver failure;
• teţave z ledvicami;
Not known
• ne pušča
Adalimumab 0.8 mg/kg eow N=38
Adalimumab 0,8 mg/kg vsak drugi teden N = 38
Hypertension, flushing, haematoma
Ţilne bolezni pogosti hipertenzija, zardevanje, hematom,
Initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days),
Začetni odmerek je 160 mg (kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva dni zapored) nato sledi 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje.
Continued therapy beyond 16 weeks should be carefully reconsidered in a patient not responding within this time period.
Če se bolnik med tem obdobjem ne odzove, je pred podaljšanjem zdravljenja na več kot 16 tednov potreben natančen ponoven razmislek.
Warning: Do not use the vial if the liquid is cloudy, colored or has particles or flakes in it. 2.4 Gently remove the yellow cap from the vial.
Opozorilo: Vialo ne uporabljajte, če je tekočina motna ali obarvana ali če vsebuje delce ali kosmiče.
Warning: Do not recap the pre-filled pen.
Opozorilo: Pokrovčka ne natikajte ponovno na napolnjen injekcijski peresnik.
In paediatric patients with moderate to severe CD, the open-label adalimumab induction dose was 160/80 mg or 80/40 mg at weeks 0 and 2, respectively, dependent on a body weight cut-off of 40 kg. At week 4, patients were randomised 1:1 to either the Standard Dose (40/20 mg eow) or Low Dose (20/10 mg eow) maintenance treatment groups based on their body weight.
Pediatrični bolniki z zmerno do hudo Crohnovo boleznijo so odvisno od njihove telesne mase (več ali manj od 40 kg) dobivali odprt začetni odmerek adalimumaba 160/80 mg v 0. tednu in 80/40 mg v 2. tednu.
Injector body
Tulec Injekcijska brizga
• the injection site
• mestu injiciranja,
Common (may affect up to 1 in 10 people)
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov):