natgillin/translations-raw huggingface dataset:
If you accidentally inject SOLYMBIC more frequently than told to by your doctor or pharmacist, you should call your doctor or pharmacist and tell him/her that you have taken more.
Če ste uporabili večji odmerek zdravila SOLYMBIC, kot bi smeli Če pomotoma injicirate zdravilo SOLYMBIC pogosteje, kot vam je naročil zdravnik ali farmacevt, se morate posvetovati z njim ali s farmacevtom in mu povedati, da ste uporabili večji odmerek.
Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with SOLYMBIC (see section 4.4).
Oftalmologom se svetuje, da se pred začetkom zdravljenja z zdravilom SOLYMBIC posvetujejo z ustreznim specialistom (glejte poglavje 4.4).
Rates of discontinuation of corticosteroids or immunomodulators are presented in table 21.
Stopnja prenehanja zdravljenja s kortikosteroidi ali imunomodulatorji je predstavljena v preglednici 21.
As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting SOLYMBIC.
• Ker so bili pri bolnikih, zdravljenih z adalimumabom, opisani primeri tuberkuloze, vas bo zdravnik pred začetkom zdravljenja z zdravilom SOLYMBIC preiskal glede znakov in simptomov tuberkuloze.
PGA-F clear/minimal and ≥ 2-grade improvement a a
PGA-F čisto/minimalno in ≥ izboljšanje za dva razreda (%)
Following the administration of 24 mg/m
Po dajanju 24 mg/m
95% confidence intervals for the differences in change scores between methotrexate and adalimumab c Based on rank analysis d
d ametotreksat 95% intervali zaupanja za razlike v spremembi ocen med metotreksatom in adalimumabom cna podlagi analize rangov zožitev sklepne špranje
Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with SOLYMBIC.
Kortikosteroide, ki se jih daje sočasno, se lahko postopoma ukinja v skladu s klinično prakso, z začetkom dva tedna po začetku zdravljenja z zdravilom SOLYMBIC.
Figure 1: Kaplan-Meier curves summarising time to treatment failure on or after week 6 (study UV I) or week 2 (study UV II)
Slika 1: Kaplan-Meier-jeve krivulje povzemajo čas do neuspeha zdravljenja v ali po 6. tednu (študija UV I) ali 2. tednu (študija UV II)
Non-infectious uveitis affecting the back of the eye
Neinfekcijski uveitis, ki prizadene zadnji del očesa
If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of SOLYMBIC, and in accordance with local recommendations.
Če se ugotovi latentna tuberkuloza, se mora pred uvedbo zdravila SOLYMBIC začeti s protituberkuloznim profilaktičnim zdravljenjem v skladu z lokalnimi priporočili.
At week 12, a significantly higher proportion of patients in study HS-II experienced a clinically relevant decrease in HS-related skin pain (see table 15).
V 12. tednu je statistično pomembno večji delež bolnikov v študiji HS-II občutil klinično pomembno zmanjšanje bolečine na koži, povezane s HS (glejte preglednico 15).
Detailed instructions for use are provided in the package leaflet.
Podrobna navodila za uporabo so navedena v navodilu za uporabo.
Patients on SOLYMBIC may receive concurrent vaccinations, except for live vaccines.
Bolniki, ki prejemajo zdravilo SOLYMBIC, lahko sočasno dobijo cepiva, razen živih cepiv.
Treatment with SOLYMBIC should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Zdravljenja z zdravilom SOLYMBIC se ne sme začeti pri bolnikih z aktivnimi okužbami, vključno s kroničnimi ali lokaliziranimi, dokler te niso obvladane.
Certain vaccines may cause infections and should not be given while receiving SOLYMBIC.
• Določena cepiva lahko povzročijo okužbe, zato se jih med zdravljenjem z zdravilom SOLYMBIC ne sme uporabljati.
If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with SOLYMBIC and is positive for antibodies against double-stranded DNA, further treatment with SOLYMBIC should not be given (see section 4.8).
Če se bolniku po zdravljenju z zdravilom SOLYMBIC pojavijo simptomi, ki nakazujejo lupusu podobni sindrom, in ima pozitivna protitelesa proti dvojnoverižni DNA, zdravljenja z zdravilom SOLYMBIC ne sme nadaljevati (glejte poglavje 4.8).
It is not known whether SOLYMBIC passes into breast milk.
Ni znano, ali se zdravilo SOLYMBIC izloča v materinem mleku.
If you take SOLYMBIC the risk of getting lymphoma, leukaemia, or other cancers may increase.
Če uporabljate zdravilo SOLYMBIC, se vam lahko poveča tveganje za pojav limfoma, levkemije ali drugih vrst raka.
Week 52 Fistula remission
52. teden Remisija fistule
The benefits and risks of continued weekly therapy should be carefully reconsidered in a patient with an inadequate response after the increase in dosing frequency (see section 5.1).
Koristi in tveganja nadaljevanja tedenskega zdravljenja je treba ponovno natančno pretehtati pri bolniku z nezadostnim odzivom na zdravljenje po povečanju pogostnosti odmerjanja (glejte poglavje 5.1).
However, because human immunoglobulins are excreted in milk, women must not breast-feed for at least five months after the last SOLYMBIC treatment.
Ker se človeški imunoglobulini izločajo v mleku, ženske ne smejo dojiti vsaj pet mesecev po zadnjem zdravljenju z zdravilom SOLYMBIC.
You should not take SOLYMBIC with medicines containing the active substance, anakinra or abatacept.
Zdravila SOLYMBIC ne smete jemati z zdravili, ki vsebujejo učinkovini anakinro ali abatacept.
Table 23 Time to treatment failure in studies UV I and UV II
Čas do neuspeha zdravljenja v študijah UV I in UV II
SOLYMBIC is a biosimilar medicinal product.
Zdravilo SOLYMBIC je biološko podobno zdravilo.
• Relevant information on the safety concerns of serious infections, sepsis, tuberculosis and opportunistic infections; congestive heart failure; demyelinating disorders; malignancies to be addressed by the additional risk minimisation measures (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable).
• Pomembne informacije o varnostnih zadržkih glede resnih okužb, sepse, tuberkuloze in oportunističnih okužb; kongestivnega srčnega popuščanja; demielinizirajoče bolezni; malignih bolezni, ki jih je treba obravnavati z dodatnimi ukrepi za zmanjševanje tveganja (npr. resnost, hudost, frekvenca, čas do pojava, reverzibilnost neželenih dogodkov, kot je primerno).
People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma (a type of cancer that affects the lymph system), and leukaemia (a type of cancer that affects the blood and bone marrow).
Pri bolnikih z resnejšim revmatoidnim artritisom, ki imajo bolezen že dolgo, obstaja povečana verjetnost, da zbolijo za limfomom (vrsto raka, ki prizadene limfatični sistem) in levkemijo (vrsto raka, ki prizadene kri in kostni mozeg).
Patients should be tested for HBV infection before initiating treatment with SOLYMBIC.
Bolnike je treba pred začetkom zdravljenja z zdravilom SOLYMBIC testirati na okužbo s HBV.
Both studies demonstrated an early and sustained effect of adalimumab on the treatment failure rate versus placebo (see figure 1).
V obeh študijah je bil dokazan zgodnji in vzdrževan učinek adalimumaba na odstotek neuspeha zdravljenja proti placebu (glejte sliko 1).
Concomitant administration of SOLYMBIC 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 (see section
Sočasna uporaba zdravila SOLYMBIC z drugimi biološkimi DMARDS (t.j.anakinra in abacept) ali z drugimi antagonisti TNF ni priporočljiva zaradi možnega povečanega tveganja za okužbe, vključno z resnimi okužbami, in drugih potencialnih farmakoloških interakcij (glejte poglavje 4.5).
In patients who develop HBV reactivation, SOLYMBIC 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 SOLYMBIC prekiniti in uvesti učinkovito protivirusno terapijo z ustreznim podpornim zdravljenjem.
Usually, SOLYMBIC is used with methotrexate.
Zdravilo SOLYMBIC ponavadi uporabljamo z metotreksatom.
If an anaphylactic reaction or other serious allergic reaction occurs, administration of SOLYMBIC should be discontinued immediately and appropriate therapy initiated.
Če se pojavi anafilaktična reakcija ali kakšna druga resna alergijska reakcija, je treba uporabo zdravila SOLYMBIC nemudoma prekiniti in uvesti ustrezno zdravljenje.
How to store SOLYMBIC Contents of the pack and other information
Shranjevanje zdravila SOLYMBIC Vsebina pakiranja in dodatne informacije
In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using SOLYMBIC.
V primeru neinfekcijskega uveitisa se kortikosteroidi ali druga zdravila, ki zavirajo imunski sistem, lahko še nadalje uporabljajo ob uporabi zdravila SOLYMBIC.
Children or adolescents with Crohn's disease
Otroci ali mladostniki s Crohnovo boleznijo
SOLYMBIC may have a minor influence on your ability to drive, cycle or use machines.
Zdravilo SOLYMBIC ima lahko blag vpliv na sposobnost vožnje, kolesarjenja ali upravljanja s stroji.
Therefore, the combination of SOLYMBIC and anakinra is not recommended (see section 4.5).
Zato kombinacija zdravila SOLYMBIC in anakinre ni priporočljiva (glejte poglavje 4.5).
Mood alterations (including depression), Anxiety,
Psihiatrične motnje spremembe razpoloženja (vključno z depresijo), anksioznost, nespečnost
If you are about to undergo surgery or dental procedures please inform your doctor that you are taking SOLYMBIC.
• Če boste imeli kirurški poseg ali poseg na zobeh, prosimo, povejte svojemu zdravniku, da jemljete zdravilo SOLYMBIC.
If adequate response is achieved with an increased dosing frequency, the dose may subsequently be reduced to 40 mg every other week.
Če je dosežen zadosten odziv na zdravljenje s povečano pogostnostjo odmerjanja, se lahko odmerek pozneje zmanjša na 40 mg vsak drugi teden.
If you have an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting SOLYMBIC.
• Če imate kakšno okužbo, vključno z dolgotrajno ali omejeno okužbo (npr. razjedo na nogi), se pred uporabo zdravila SOLYMBIC posvetujte s svojim zdravnikom.
Table 9 Efficacy response in placebo-controlled axial SpA study
Odziv učinkovitosti v s placebom kontrolirani Axial SpA študiji
Before you use a SOLYMBIC pre-filled syringe, read this important information:
Pred uporabo napolnjene injekcijske brizge zdravila SOLYMBIC preberite te pomembne informacije:
Clinical remission Clinical response (CR-100) Patients in steroid-free remission for > = 90 days a
Klinična remisija Klinični odziv (CR-100) Bolniki v remisiji brez steroidov za ≥ 90 dni a
Patients treated with SOLYMBIC should be given the special alert card.
Bolniki, ki se zdravijo z zdravilom SOLYMBIC, morajo dobiti opozorilno kartico za bolnike.
Alternatively, if a patient has stopped SOLYMBIC and signs and symptoms of disease recur, SOLYMBIC may be re-administered.
Če bolnik neha uporabljati zdravilo SOLYMBIC, pa se znaki in simptomi bolezni ponovijo, je mogoče zdravilo SOLYMBIC znova uvesti.
Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (See table 23).
Rezultati iz obeh študij kažejo statistično značilno zmanjšanje tveganja za neuspeh zdravljenja pri bolnikih, ki so prejemali adalimumab, v primerjavi z bolniki, ki so prejemali placebo (glejte preglednico 23).
Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with SOLYMBIC.
Bolnike je zato treba pred, med in po zdravljenju z zdravilom SOLYMBIC natančno kontrolirati glede okužb, vključno s tuberkulozo.
What SOLYMBIC is and what it is used for What you need to know before you use SOLYMBIC How to use SOLYMBIC
Kaj je zdravilo SOLYMBIC in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo SOLYMBIC Kako uporabljati zdravilo SOLYMBIC Možni neželeni učinki
Table 8 Efficacy responses in placebo-controlled AS study - study I reduction of signs and symptoms
Odzivi učinkovitosti v študiji pri ankilozirajočem spondilitisu, kontrolirani s placebom - študija I zmanjšanje znakov in simptomov
Keep SOLYMBIC in the outer carton in order to protect from light.
Zdravilo SOLYMBIC shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
SOLYMBIC is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Zdravilo SOLYMBIC se uporablja za zdravljenje Crohnove bolezni pri odraslih in otrocih, starih 6 do 17 let.
Greater improvements at week 12 from baseline compared to placebo were demonstrated in skinspecific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; Studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the Treatment Satisfaction Questionnaire-medication (TSQM; Studies HS-I and HS-II), and physical health as measured by the physical component summary score of the SF-36 (study HS-I).
Večje izboljšanje v 12. tednu so pokazali glede na izhodiščno vrednost v primerjavi s placebom glede z zdravjem povezane kakovosti življenja, specifične za kožo, merjene z dermatološkim indeksom kakovosti življenja (“Dermatology life quality index” (DLQI), v študijah HS-I in HS-II), glede bolnikovega splošnega zadovoljstva z zdravljenjem z zdravilom, merjenem z vprašalnikom o zadovoljstvu z zdravljenjem z zdravilom (“Treatment Satisfaction Questionnaire - medication” (TSQM), v študijah HS-I in HS-II), in glede telesnega zdravja, merjenega s seštevkom telesnih komponent v vprašalniku SF-36 (“Short Form Health Survey" (SF 36) v študiji HS-I).
The volume for injection is selected based on the patients' height and weight (table 1).
Volumen za injiciranje se določi glede na bolnikovo višino in telesno maso (glejte preglednico 1).
Treatment with SOLYMBIC may result in the formation of autoimmune antibodies.
Zdravljenje z zdravilom SOLYMBIC lahko povzroči nastanek avtoimunskih protiteles.
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 11 and 12).
V študijah pri psoriazi I in II je bil primarna končna točka delež bolnikov, ki so od izhodišča do 16. tedna dosegli PASI 75 (glejte preglednici 11 in 12).
During treatment with SOLYMBIC, other concomitant therapies (e.g. corticosteroids and/or immunomodulatory agents) should be optimised.
Med zdravljenjem z zdravilom SOLYMBIC je treba optimizirati druge sočasne terapije (npr. kortikosteroide in/ali imunomodulacijska zdravila).
Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see table 13).
Ocena psoriaze nohtov je vključevala prilagojeni indeks izrazitosti psoriaze nohtov (mNAPSI - Modified Nail Psoriasis Severity Index), zdravnikovo globalno oceno psoriaze nohtov (PGA-F - Physician's Global Assessment of Fingernail Psoriasis) in indeks izrazitosti psoriaze nohtov (NAPSI - Nail Psoriasis Severity Index) (glejte preglednico 13).
SOLYMBIC works by reducing this inflammation.
Zdravilo SOLYMBIC deluje tako, da zmanjša tako vnetje.
1 p value for standard dose versus low dose comparison Immunosuppressant therapy could only be discontinued at or after week 26 at the investigator's discretion if the subject met the clinical response criterion defined as a closure of all fistulas that were draining at baseline for at least 2 consecutive post-baseline visits
1p vrednost za primerjavo standardnega odmerka proti majhnemu odmerku 2Zdravljenje z imunosupresivi je bilo lahko prekinjeno v 26. tednu ali po njem po raziskovalčevi diskreciji, če je bolnik izpolnjeval kriterije kliničnega odziva 3definiran kot zaprtje vseh fistul, ki so bile prisotne ob začetku študije na vsaj 2 zaporednih obiskih po začetku
Patients who develop a new infection while undergoing treatment with SOLYMBIC, should be monitored closely and undergo a complete diagnostic evaluation.
Bolnike, pri katerih se med zdravljenjem z zdravilom SOLYMBIC pojavi nova okužba, je treba natančno nadzirati in opraviti morajo popolno diagnostično obravnavo.
SOLYMBIC is also used to treat severe plaque psoriasis in children and adolescents weighing either 23 to 28 kg or 47 kg or greater for whom topical therapy and phototherapies have either not worked very well or are not suitable.
Zdravilo SOLYMBIC se uporablja tudi za zdravljenje hude luskavice v plakih pri otrocih in mladostnikih, ki tehtajo ali od 23 do 28 kg ali 47 kg ali več, pri katerih lokalno zdravljenje in zdravljenja s svetlobo nista dovolj dobro delovala ali pa nista primerna.
SOLYMBIC can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Zdravilo SOLYMBIC je mogoče uporabljati tudi za zdravljenje hudega, aktivnega in napredujočega revmatoidnega artritisa brez predhodnega zdravljenja z metotreksatom.
In rheumatoid arthritis, methotrexate is continued while using SOLYMBIC.
Pri revmatoidnem artritisu se uporaba metotreksata med uporabo zdravila SOLYMBIC nadaljuje.
For subcutaneous use.
Subkutana uporaba.
After proper training in injection technique, patients may self-inject with SOLYMBIC if their physician determines that it is appropriate and with medical follow-up as necessary.
Bolniki, ki se naučijo pravilnega postopka injiciranja, si zdravilo SOLYMBIC lahko injicirajo sami, če zdravnik presodi, da je to primerno, in je zagotovljeno ustrezno medicinsko spremljanje.
Two weeks later (day 29) continue with a dose of 40 mg every week.
Čez dva tedna (29. dan) nadaljujte z odmerkom 40 mg vsak teden.
Among patients who were at least partial responders at week 12, and who received continuous weekly adalimumab therapy, the HiSCR rate at week 48 was 68.3% and at week 96 was 65.1%.
Med bolniki, ki z vsaj delnim odzivom v 12. tednu, in ki so prejemali neprekinjeno tedensko terapijo z adalimumabom vsak teden, je bila stopnja kliničnega odziva (HiSCR) v 48. tednu 68,3 % in v 96. tednu 65,1 %.
Some of those patients were also treated with azathioprine or 6-mercaptopurine.
Nekateri od teh bolnikov so bili zdravljeni tudi z azatioprinom ali 6-merkaptopurinom.
Week 12 results showed statistically significant improvement of the signs and symptoms of active non-radiographic axial spondyloarthritis in patients treated with adalimumab compared to placebo (table 9).
Rezultati po 12. tednu so pokazali statistično pomembno izboljšanje znakov in simptomov aktivnega ne-radiografskega aksialnega spondiloartritisa pri bolnikih, ki so bili zdravljeni z adalimumabom v primerjavi s placebom (preglednica 9).
Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n = 91 placebo and n = 87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n = 73 placebo and n = 70 adalimumab h
d povprečna sprememba od začetka zdravljenja e n=91 placebo in n=87 adalimumab f hs-CRP = C-reaktivni protein z veliko občutljivostjo (high sensitivity C-Reactive Protein) (mg/l) g n=73 placebo in n=70 adalimumab h
• A warning message for HCPs treating the patient at any time, including in conditions of emergency, that the patient is using Solymbic.
• Opozorilo za zdravstvene delavce, ki kadar koli zdravijo bolnika, vključno v izrednih razmerah,
Spondyloarthritis Research Consortium of Canada i n = 84 placebo and adalimumab j n = 82 placebo and n = 85 adalimumab ***, **, * Statistically significant at p < 0.001, < 0.01, and < 0.05, respectively, for all comparisons between adalimumab and placebo
i n=84 placebo in adalimumab j n=82 placebo in n=85 adalimumab ***, **, * Statistično pomembno pri p < 0,001, < 0,01 in < 0,05, v tem zaporedju, za vse primerjave med adalimumabom in placebom.
The safety and efficacy of adalimumab in children aged 12-17 years have not yet been established for hidradenitis suppurativa.
Varnost in učinkovitost adalimumaba pri otrocih, starih 12-17 let, za hidradenitis suppurativa ni bila potrjena.
All p-values are pairwise comparisons of proportions for adalimumab versus placebo * p < 0.001
Vse vrednosti p so za parne primerjave deležev med adalimumabom in placebom * p < 0,001
SOLYMBIC reduces the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and improves physical function.
Rentgensko slikanje je pokazalo, da zdravilo SOLYMBIC upočasni hitrost napredovanja prizadetosti perifernih sklepov pri bolnikih s poliartikularnimi, simetričnimi podtipi bolezni (glejte poglavje 5.1) in izboljša telesno funkcijo.
PGA: Clear/minimal b a Percent of patients achieving PASI75 response was calculated as centre-adjusted rate b p < 0.001, adalimumab versus placebo
PGA: čisto/minimalno b a Odstotek bolnikov, ki so dosegli odziv PASI 75, je bil izračunan kot delež, korigiran za center b p < 0,001, adalimumab v primerjavi s placebom
Patients were then retreated with adalimumab 0.8 mg/kg every other week for an additional 16 weeks and response rates observed during retreatment were similar to the previous double-blind period: PASI 75 response of 78.9% (15 of 19 subjects) and PGA clear or minimal of 52.6% (10 of 19 subjects).
Bolniki so bili nato znova zdravljeni z adalimumabom v odmerku 0,8 mg/kg vsak drugi teden še nadaljnjih 16 tednov, pri čemer so bile opažene stopnje odziva podobne kot v prejšnjem dvojno slepem obdobju: odziv PASI 75 pri 78,9 % (15 od 19 oseb) in PGA čisto ali minimalno pri 52,6 % (10 od 19 oseb).
Administration of live vaccines to infants exposed to adalimumab in utero is not recommended for 5 months following the mother's last adalimumab injection during pregnancy.
Uporaba živih cepiv pri dojenčkih, ki so bili izpostavljeni adalimumabu in utero, ni priporočljiva 5 mesecev po zadnji injekciji adalimumaba, ki jo je mati prejela med nosečnostjo.
What SOLYMBIC contains - The active substance is adalimumab.
Kaj vsebuje zdravilo SOLYMBIC - Zdravilna učinkovina je adalimumab.
Table 18 Maintenance of clinical remission and response (percent of patients)
Preglednica 18: Vzdrževanje klinične remisije in odziva (odstotek bolnikov)
Paediatric Crohn's disease patients < 40 kg:
Crohnova bolezen pri pediatričnih bolnikih < 40 kg:
a a a p < 0.001, Adalimumab versus placebo
a a p < 0,001, adalimumab v primerjavi s placebom
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 19.
V 4.tednu so bili bolniki glede na njihovo telesno maso v tem času randomizirani v razmerju 1:1 bodisi v vzdrževalni režim z majhnim odmerkom ali vzdrževalni režim s standardnim odmerkom, kot kaže preglednica 19.
ASASa 40
a40
In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see table 7).
V študiji revmatoidnega artritisa V so strukturno okvaro sklepov ocenili rentgenografsko in jo izrazili kot razliko v modificirani celotni Sharpovi oceni (glejte preglednico 7).
Total Sharp Score c
Celotna Sharpova ocena c
Paediatric Crohn's disease patients ≥ 40 kg:
Crohnova bolezen pri pediatričnih bolnikih ≥ 40 kg:
The results for the 40 mg every other week dose are summarised in table 4.
Rezultati odmerka 40 mg vsak drugi teden so strnjeni v preglednici 4.
Administration of SOLYMBIC is not recommended during pregnancy.
Uporaba zdravila SOLYMBIC med nosečnostjo ni priporočljiva.