natgillin/translations-raw huggingface dataset:
SOLYMBIC can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Zdravilo SOLYMBIC se lahko uporablja skupaj z metotreksatom ali nekaterimi imunomodulirajočimi antirevmatičnimi zdravili (sulfasalazinom, hidroksiklorokinom, leflunomidom in pripravki zlata za injiciranje), steroidi in zdravili proti bolečinam, vključno z nesteroidnimi protivnetnimi zdravili (NSAID).
SOLYMBIC 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 SOLYMBIC 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.
SOLYMBIC slows down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.
Zdravilo SOLYMBIC upočasni okvaro sklepnega hrustanca in kosti, ki jo povzroča ta bolezen in izboljšuje telesno delovanje.
If you have mild heart failure and you are being treated with SOLYMBIC, your heart failure status must be closely monitored by your doctor.
• Če imate blago srčno popuščanje in se zdravite z zdravilom SOLYMBIC, mora zdravnik natančno nadzorovati stanje vašega srčnega popuščanja.
In patients with at least a partial response to adalimumab 40 mg weekly at week 12, the HiSCR rate at week 36 was higher in patients who continued weekly adalimumab than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see table 16).
Pri bolnikih z vsaj delnim odzivom na adalimumab v odmerku 40 mg vsak teden v 12. tednu, je bila stopnja kliničnega odziva (HiSCR) v 36. tednu višja pri bolnikih, ki so nadaljevali zdravljenje z adalimumabom vsak teden kot pri bolnikih, pri katerih so pogostnost odmerjanja zmanjšali na vsak drugi teden, ali pri katerih je bilo zdravljenje ukinjeno (glej preglednico 16).
Impaired renal and/or hepatic function
Okvarjena funkcija ledvic in/ali jeter
Physicians should exercise caution when considering the use of SOLYMBIC in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Pri odločanju za uporabo zdravila SOLYMBIC je potrebna previdnost pri bolnikih z anamnezo ponavljajoče se okužbe ali z osnovnimi boleznimi, ki lahko zvečajo nagnjenost k okužbam, vključno s sočasno uporabljenimi imunosupresivnimi zdravili.
Systemic lupus erythematosus Lupus-like syndrome
občasni rabdomioliza, sistemski eritematozni lupus sindrom podoben lupusu
How to use SOLYMBIC
Kako uporabljati zdravilo SOLYMBIC
The combination of SOLYMBIC and abatacept is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”).
Kombinacija zdravila SOLYMBIC in abatacepta ni priporočljiva (glejte poglavje 4.4 “Sočasna uporaba bioloških DMARDS ali antagonistov TNF”).
SOLYMBIC is injected under the skin (subcutaneous use).
Zdravilo SOLYMBIC se injicira pod kožo (subkutana uporaba).
The recommended dose of SOLYMBIC for patients with enthesitis-related arthritis, aged 6 to 17 years depends on the height and weight of the child.
Priporočeni odmerek zdravila SOLYMBIC za bolnike z artritisom, povezanim z entezitisom, stare od 6 do 17 let, je odvisen od višine in telesne mase otroka.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE UČINKOVINE INIZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
SOLYMBIC dose in milligrams (mg) by height and weight of patients for enthesitis-related arthritis
Odmerek zdravila SOLYMBIC v miligramih (mg) glede na višino in telesno maso bolnikov za artritis, povezan z entezitisom
Clinical response is decrease from baseline in Mayo score ≥ 3 points and ≥ 30% plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS of 0 or 1; * p < 0.05 for adalimumab versus placebo pairwise comparison of proportions ** p < 0.001 for adalimumab versus placebo pairwise comparison of proportions a
Klinični odgovor pomeni znižanje ocene Mayo od začetka za ≥ 3 in ≥ 30% ter znižanje podocene rektalne krvavitve [RBS] ≥ 1 ali absolutna RBS 0 ali 1; *p < 0,05 za parno primerjavo deležev med adalimumabom in placebom **p < 0,001 za parno primerjavo deležev med adalimumabom in placebom a Od tistih, ki so izhodiščno prejemali kortikosteroide
Total body weight (kg)
Celotna telesna masa (kg)
MRI Sacroiliac Joints d,i
MRI sakroiliakalnih sklepov d,i
On rare occasions, a specific and severe type of lymphoma has been observed in some patients taking adalimumab.
V redkih primerih so pri nekaterih bolnikih, ki dobivajo adalimumab, opazili specifično in resno obliko limfoma.
Prescribers should exercise caution in considering the use of SOLYMBIC in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of SOLYMBIC should be considered if any of these disorders develop.
Pri odločanju za uporabo zdravila SOLYMBIC pri bolnikih z že prej obstoječimi ali nedavno nastalimi demielinizirajočimi boleznimi osrednjega ali perifernega živčevja je potrebna previdnost; če se razvije katera od teh bolezni, je treba razmisliti o prenehanju zdravljenja z zdravilom SOLYMBIC.
Table 22 Response, remission and mucosal healing in study UC-II (percent of patients)
Odziv, remisija in celjenje sluznice v študiji UC-II (odstotek bolnikov)
What SOLYMBIC looks like and contents of the pack
Izgled zdravila SOLYMBIC in vsebina pakiranja
Very common Injection site reaction (including injection site erythema) Common
reakcija na mestu injiciranja (vključno z eritemom na mestu injiciranje)
Vaccinations: if possible children should be up to date with all vaccinations before using SOLYMBIC.
• Cepljenja: če je mogoče, naj vaš otrok pred začetkom uporabe zdravila SOLYMBIC opravi vsa potrebna cepljenja.
A patient who requires surgery while on SOLYMBIC should be closely monitored for infections, and appropriate actions should be taken.
Bolnika, ki med zdravljenjem z zdravilom SOLYMBIC potrebuje operacijo, je treba natančno nadzirati glede okužb in ustrezno ukrepati.
Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to the initiation of SOLYMBIC therapy and regularly during treatment to assess for pre-existing or developing central demyelinating disorders.
Pri bolnikih z neinfekcijskim intermediarnim uveitisom je treba pred začetkom zdravljenja z zdravilom SOLYMBIC in redno med zdravljenjem opravljati nevrološko oceno, da se oceni že obstoječe ali razvijajoče se demielinizirajoče bolezni osrednjega živčevja.
Administration of live vaccines to infants exposed to SOLYMBIC in utero is not recommended for 5 months following the mother's last SOLYMBIC injection during pregnancy.
Uporaba živih cepiv pri dojenčkih, ki so bili izpostavljeni zdravilu SOLYMBIC in utero, ni priporočljiva še 5 mesecev po materini zadnji injekciji zdravila SOLYMBIC med nosečnostjo.
Packs size of one pre-filled syringe.
Velikost pakiranja z eno napolnjeno injekcijsko brizgo.
Administration of SOLYMBIC should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Če se bolniku pojavi nova resna okužba ali sepsa, je treba uporabo zdravila SOLYMBIC prekiniti in uvesti ustrezno protimikrobno ali protimikotično zdravljenje, dokler okužba ni obvladana.
Methotrexate should be continued during treatment with SOLYMBIC.
Med zdravljenjem z zdravilom SOLYMBIC je treba še naprej uporabljati metotreksat.
SOLYMBIC is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Zdravilo SOLYMBIC je indicirano za zdravljenje zmerne do hude kronične psoriaze v plakih pri odraslih bolnikih, ki so kandidati za sistemsko zdravljenje.
The decision to stop using SOLYMBIC should be discussed with your doctor.
Če ste prenehali uporabljati zdravilo SOLYMBIC O odločitvi, da bi prenehali uporabljati zdravilo SOLYMBIC, se morate posvetovati s svojim zdravnikom.
SOLYMBIC is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs.
Zdravilo SOLYMBIC je indicirano za zdravljenje odraslih s hudim aksialnim spondiloartritisom brez radiografskega dokaza za AS, toda z objektivnimi znaki vnetja s povišanimi CRP in/ali MRI, ki so nezadostno reagirali na ali ne prenašajo nesteroidnih protivnetnih zdravil.
Children with enthesitis-related arthritis
Otroci z artritisom, povezanim z entezitisom
On a clean, well-lit work surface, place a new, pre-filled syringe.
Na čisto, dobro osvetljeno delovno površino položite novo napolnjeno injekcijsko brizgo.
A 40 mg pen, and a 20 mg and 40 mg pre-filled syringes are available for patients to administer a full 20 mg or 40 mg dose.
40 mg peresnik ter 20 mg in 40 mg napolnjeni injekcijski brizgi so na voljo za bolnike za dajanje polnega 20 mg ali 40 mg odmerka.
Assessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa (Bath Ankylosing Spondylitis Disease Activity Index)
A. Remove the number of SOLYMBIC pre-filled syringes you need from the package.
A. Vzemite potrebno število napolnjenih injekcijskih brizg zdravila SOLYMBIC iz škatle.
SOLYMBIC is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).
Zdravilo SOLYMBIC je indicirano za zdravljenje aktivnega artritisa, povezanega z entezitisom pri bolnikih, starih 6 let in več, ki so se neustrezno odzvali ali so intolerantni za kovencionalno zdravljenje (glejte poglavje 5.1).
Packs sizes of one, two, four and six pre-filled syringes.
Velikosti pakiranj po ena, dve, štiri in šest napolnjenih injekcijskih brizg.
If you forget to use SOLYMBIC
Če ste pozabilli uporabiti zdravilo SOLYMBIC
SOLYMBIC is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.
Zdravilo SOLYMBIC je indicirano za zdravljenje neinfekcijskega intermediarnega, posteriornega uveitisa in panuveitisa pri odraslih bolnikih, ki se niso zadostno odzvali na zdravljenje s kortikosteroidi, pri bolnikih s potrebo po zmanjšani uporabi kortikosteroidov ali pri bolnikih, pri katerih je zdravljenje s kortikosteroidi neprimerno.
Coagulation and bleeding disorders (including activated partial thromboplastin time prolonged), Autoantibody test positive (including double stranded DNA antibody),
koagulacija in motnje krvavenja (vključno s podaljšanim aktiviranim parcialnim tromboplastinskim časom), prisotnost avtoprotiteles (vključno s protitelesi proti dvovijačni DNA), zvišanje laktat dehidrogenaze v krvi
(up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 µg/mL for adalimumab without concomitant methotrexate and 11.8 ± 4.3 µg/mL with concomitant methotrexate.
(do največ 40 mg) subkutano vsak drugi teden bolnikom z artritisom, povezanim z entezitisom, ki so bili stari od 6 do 17 let, je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja (vrednost merjena v 24. tednu) 8,8 ± 6,6 μg/ml med uporabo adalimumaba brez metotreksata in 11,8 ± 4,3 μg/ml med sočasno uporabo metotreksata.
No dose adjustment is required.
Starejši bolniki Prilagoditev odmerka ni potrebna.
At week 52, 42.9% of patients who received adalimumab/methotrexate combination therapy achieved clinical remission (DAS28 < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving adalimumab monotherapy.
Po 52. tednih je klinično remisijo (DAS28 < 2,6) doseglo 42,9 % bolnikov, ki so dobivali kombinirano terapijo z adalimumabom/metotreksatom, 20,6 % bolnikov, ki so dobivali metotreksat v monoterapiji, in 23,4 % bolnikov, ki so dobivali adalimumab v monoterapiji.
Table 20 Paediatric CD study PCDAI clinical remission and response
Študija Crohnove bolezni pri pediatričnih bolnikih PCDAI klinična remisija in odziv
Adalimumab 160/80 mg N = 76
adalimuma b 160/80 mg N = 76
Table 10 ACR response in placebo-controlled psoriatic arthritis studies (percent of patients)
Odziv ACR v študijah pri psoriatičnem artritisu, kontroliranih s placebo (odstotek bolnikov)
Tell your doctor if you are taking azathioprine or 6-mercaptopurine with SOLYMBIC.
Povejte zdravniku, če vaš otrok prejema azatioprin ali 6-merkaptopurin sočasno z zdravilom SOLYMBIC.
The safety and efficacy of adalimumab in children aged 2-17 years have not yet been established.
Varnost in učinkovitost adalimumaba pri otrocih starih 2-17 let nista bili dokazani.
MTX = methotrexate b P = 0.027, adalimumab 0.8 mg/kg versus MTX
PGA: čisto/minimalno a MTX = methotrexate b P = 0,027, adalimumab 0,8 mg/kg v primerjavi z MTX c P = 0,083, adalimumab 0,8 mg/kg v primerjavi z MTX
Make sure the medicine in the window is clear and colourless to slightly yellow.
Prepričajte se, da je zdravilo v okencu bistro in brezbarvno do rahlo rumenkasto.
PGA: Clear/minimal a, b a p < 0.001 adalimumab versus placebo b p < 0.001 adalimumab versus methotrexate c p < 0.01 adalimumab versus placebo d p < 0.05 adalimumab versus methotrexate
PGA: čisto/minimalno a, b a p < 0,001 adalimumab v primerjavi s placebom b p < 0,001 adalimumab v primerjavi z metotreksatom c p < 0,01 adalimumab v primerjavi s placebom d p < 0,05 adalimumab v primerjavi z metotreksatom
Table 2 SOLYMBIC dose in milligrams (mg) by weight for patients with paediatric psoriasis
Odmerek zdravila SOLYMBIC v miligramih (mg) glede na telesno maso bolnikov s pediatrično psoriazo
Week 26 Clinical remission Clinical response Week 52 Clinical remission Clinical response * p value for standard dose versus low dose comparison
26. teden Klinična remisija Klinični odziv 52. teden Klinična remisija Klinični odziv
Thirty-three (18%) of patients were treated concomitantly with disease-modifying anti-rheumatic drugs, and 146 (79%) patients with NSAIDs at baseline.
33 (18 %) bolnikov je bilo na začetku sočasno zdravljenih z modifikatorji bolezni ali protirevmatskimi zdravili in 146 (79 %) bolnikov z nesteroidnimi antirevmatiki.
Beyond 16 weeks, patients with inadequate response may benefit from an increase in dosing frequency to 40 mg every week.
Od 16. tedna dalje bolnikom z nezadostnim odzivom na zdravljenje lahko koristi povečanje pogostnosti odmerjanja na 40 mg vsak teden.
After two further weeks, continue with a dose of 40 mg every week.
Čez nadaljnja dva tedna nadaljujte z odmerkom 40 mg vsak teden.
In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with adalimumab and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and adalimumab monotherapy at week 52 and responses were sustained at week 104 (see table 5).
V študiji revmatoidnega artritisa V pri bolnikih z zgodnjim revmatoidnim artritisom, ki še niso dobivali metotreksata, je kombinirana terapija z adalimumabom in metotreksatom po 52 tednih prinesla hitrejše in značilno večje odzive ACR kakor monoterapija z metotreksatom ali monoterapija z adalimumabom, odzivi pa so se ohranili do 104. tedna (glejte preglednico 5).
● Put the used SOLYMBIC syringe in a sharps disposal container immediately after use.
● Uporabljeno brizgo zdravila SOLYMBIC nemudoma po injiciranju dajte v vsebnik za ostre odpadke.
Table 21 Paediatric CD study discontinuation of corticosteroids or immunomodulators and fistula remission
Študija Crohnove bolezni pri pediatričnih bolnikih: Prenehanje zdravljenja s kortikosteroidi ali imunomodulatorji in remisija fistule
SOLYMBIC contains sodium
Zdravilo SOLYMBIC vsebuje natrij
On a clean, well-lit work surface, place a new, pre-filled pen.
Na čisto, dobro osvetljeno delovno površino položite nov napolnjen injekcijski peresnik.
Placebo/MTXadalimumab /MTX (95% confidence interval b)
adalimumab /MTX 40 mg vsak drugi teden placebo/MTXadalimumab/ MTX (95 % interval zaupanja b)
SOLYMBIC is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic HS therapy.
Zdravilo SOLYMBIC je indicirano za zdravljenje aktivne zmerne do hude oblike hidradenitis suppurativa (acne inversa) pri odraslih bolnikih, ki se ne odzovejo zadovoljivo na konvencionalno sistemsko HS zdravljenje.
SOLYMBIC contains the active substance adalimumab, a selective immuno suppressive agent.
Zdravilo SOLYMBIC vsebuje zdravilno učinkovino adalimumab, selektivni zaviralec imunskega sistema.
- Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before you are given SOLYMBIC and during treatment with SOLYMBIC.
Ta vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni, preden prejmete zdravilo SOLYMBIC in med zdravljenjem z zdravilom SOLYMBIC.
Erosion score JSN
Celotna Sharpova ocena Ocena erozij Seštevek JSN
Sodium hydroxide (for pH adjustment) Water for injections
Ledocet saharoza polisorbat 80 natrijev hidroksid (za prilagoditev pH) voda za injekcije
The combination of SOLYMBIC and anakinra is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”).
Kombinacija zdravila SOLYMBIC in anakinre ni priporočljiva (glejte poglavje 4.4 “Sočasna uporaba bioloških DMARDS ali antagonistov TNF”).
If you become pregnant, you should consult your doctor.
Če zanosite, se posvetujte s svojim zdravnikom.
Glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and water for injection.
Ledocet, saharoza, polisorbat 80, natrijev hidroksid in voda za injekcije.
It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with SOLYMBIC.
Priporoča se, da med zdravljenjem z zdravilom SOLYMBIC bolnik vsakodmevno izpira HS lezije s topikalnim antiseptikom.
SOLYMBIC is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.
Zdravilo SOLYMBIC je indicirano za zdravljenje aktivnega in napredujočega psoriatičnega artritisa pri odraslih, če odziv na predhodno zdravljenje z imunomodulirajočimi antirevmatiki ni bil ustrezen.
Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu.
SOLYMBIC is intended for treatment of rheumatoid arthritis, enthesitis-related arthritis in children 6 to 17 years, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, paediatric psoriasis (patients weighing either 23 to 28 kg or 47 kg and greater), Crohn's disease in adults and children, ulcerative colitis and non-infectious uveitis affecting the back of the eye.
Zdravilo SOLYMBIC je namenjeno za zdravljenje revmatoidnega artritisa, artritisa, povezanega z entezitisom, pri otrocih, starih od 6 do 17 let, ankilozirajočega spondilitisa, aksialnega spondiloartritisa brez radiografskega dokaza za ankilozirajoči spondilitis, psoriatičnega artritisa, luskavice (psoriaze), hidradenitis suppurativa, pediatrične luskavice (pri bolnikih, ki tehtajo ali od 23 do 28 kg ali 47 kg in več), Chronove bolezni pri odraslih in otrocih, ulceroznega kolitisa in neinfekcijskega uveitisa, ki prizadene zadnji del očesa.
Not known Hepatosplenic T-cell lymphoma Merkel cell carcinoma (neuroendocrine carcinoma of the skin)
redki levkemija neznana pogostnost karcinom Merkelovih celic (nevroendokrini karcinom kože)
The recommended dose of SOLYMBIC for patients with enthesitis-related arthritis 6 years of age and older is 24 mg/m² body surface area up to a maximum single dose of 40 mg adalimumab administered every other week via subcutaneous injection.
Priporočeni odmerek zdravila SOLYMBIC pri bolnikih z artritisom, povezanim z entezitison, starih 6 let in več, je 24 mg/m telesne površine do največjega posamičnega odmerka 40 mg adalimumaba vsak drugi teden v subkutani injekciji.
SOLYMBIC reduces the rate of progression of joint damage as measured by x-ray and improves physical function, when given in combination with methotrexate.
Rentgensko slikanje je pokazalo, da zdravilo SOLYMBIC upočasni hitrost napredovanja prizadetosti sklepov in izboljša telesno funkcijo, kadar se uporablja v kombinaciji z metotreksatom.
You are advised to avoid becoming pregnant and must use adequate contraception while using SOLYMBIC and for at least 5 months after the last SOLYMBIC treatment.
Priporočljivo je, da ne zanosite, zato morate med zdravljenjem z zdravilom SOLYMBIC in vsaj še 5 mesecev po zadnjem odmerku zdravila SOLYMBIC uporabljati ustrezno kontracepcijsko zaščito.
Table 17 Induction of clinical remission and response (percent of patients)
Indukcija klinične remisije in odziva (odstotek bolnikov)
2-sided P value from log rank test. c NE = not estimable.
2-stranska vrednost p testa log-rank.
For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and/or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of SOLYMBIC should be promptly discontinued.
Če se bolniku pojavijo znaki ali simptomi, kot so npr. zvišana telesna temperatura, splošno slabo počutje, hujšanje, znojenje, kašelj, dispneja in/ali pljučni infiltrati ali druga sistemska bolezen (s spremljajočim šokom ali brez njega), je treba posumiti na invazivno glivično okužbo.
G. Hold the pinch.
G. Držite kožno gubo.
SOLYMBIC 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, a corticosteroid, and an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Zdravilo SOLYMBIC 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, kortikosteroidom in imunomodulatorjem, ali pri tistih, ki imajo intoleranco ali kontraindikacije za tako zdravljenje.
SOLYMBIC is used to treat hidradenitis suppurativa in adults.
Zdravilo SOLYMBIC se uporablja za zdravljenje hidradenitis suppurativa pri odraslih.
This includes any possible side effects not listed in this leaflet.
Posvetujte se tudi, če opazite neželene učinke, ki niso omenjeni v tem navodilu.