FrancophonIA/ELRC3.0 huggingface dataset:
English: If you do not respond well enough to these medicines, you will be given SOLYMBIC to treat your enthesitis-related arthritis.
Slovenian: Če se na ta zdravila ne odzovete dovolj dobro, boste za zdravljenje artritisa, povezanega z entezitisom, dobili zdravilo SOLYMBIC.
English: After induction treatment, the recommended dose is 20 mg every other week via subcutaneous injection.
Slovenian: Po uvodnem zdravljenju je priporočeni odmerek 20 mg vsak drugi teden v obliki subkutane injekcije.
English: SOLYMBIC is indicated for treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Slovenian: Zdravilo SOLYMBIC je indicirano za zdravljenje zmerne do hude aktivne Crohnove bolezni pri odraslih bolnikih, ki se ne odzovejo na popoln in ustrezen ciklus zdravljenja s kortikosteroidom in/ali imunosupresivom, ali pa takšnega zdravljenja ne prenesejo oz. imajo zanj medicinske kontraindikacije.
English: If you do not respond well enough to these medicines, you will be given SOLYMBIC to reduce the signs and symptoms of your Crohn's disease.
Slovenian: Če se nanje ne boste odzvali dovolj, boste za zmanjšanje znakov in simptomov Crohnove bolezni dobili zdravilo SOLYMBIC.
English: a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Slovenian: Vrednost p se nanaša na parno primerjavo monoterapije z adalimumabom in kombinirane terapije z adalimumabom/metotreksatom z Mann-Whitneyevim testom U
English: Children or adolescents with plaque psoriasis
Slovenian: Otroci ali mladostniki z luskavico v plakih
English: It is recommended that children, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating SOLYMBIC therapy.
Slovenian: Za otroke je priporočljivo, da pred začetkom zdravljenja z zdravilom SOLYMBIC opravijo vsa cepljenja v skladu z veljavnimi smernicami za cepljenje, če je le mogoče.
English: If you are a breast-feeding mother, you should stop breast-feeding during SOLYMBIC treatment and for at least 5 months after the last SOLYMBIC treatment.
Slovenian: Če dojite, morate dojenje med zdravljenjem z zdravilom SOLYMBIC prekiniti in ne smete dojiti vsaj še 5 mesecev po zadnjem odmerku zdravila SOLYMBIC.
English: Very common side effects (may affect more than 1 in 10 people):
Slovenian: Zelo pogosti neželeni učinki (lahko prizadenejo več kot 1 od 10 bolnikov):
English: Rare side effects (may affect up to 1 in 1,000 people):
Slovenian: Redki neželeni učinki (lahko prizadenejo do 1 od 1000 bolnikov):
English: Paediatric psoriasis dose
Slovenian: Odmerek za pediatrično psoriazo
English: Solid organ neoplasm (including breast cancer, lung neoplasm and thyroid neoplasm), Melanoma**
Slovenian: benigni tumor občasni limfom**, tumorji parenhimskih organov (vključno s tumorjem dojk, tumorjem pljuč in tumorjem ščitnice), melanom**
English: B. Inspect the SOLYMBIC pre-filled pen.
Slovenian: B. Preglejte napolnjeno injekcijsko brizgo zdravila SOLYMBIC.
English: Table 5 ACR responses in RA study V (percent of patients)
Slovenian: Odzivi ACR v študiji revmatoidnega artritisa V (odstotek bolnikov)
English: The recommended SOLYMBIC induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days) and 80 mg at week 2.
Slovenian: Priporočena shema odmerjanja zdravila SOLYMBIC med indukcijo je pri odraslih bolnikih z zmerno do hudo aktivnim ulceroznim kolitisom 160 mg 0. teden (odmerek se lahko da v štirih injekcijah v enem dnevu ali v dveh injekcijah na dan dva dni zapored) in 80 mg 2. teden.
English: SOLYMBIC 20 mg solution for injection in pre-filled syringe 0.4 mL solution in pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a stainless steel needle with a needle shield (thermoplastic elastomer).
Slovenian: SOLYMBIC 20 mg raztopina za injiciranje v napolnjeni injekcijski brizgi 0,4 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z batno zaporko (bromobutilni kavčuk) in z iglo iz nerjavečega jekla z varovalnim pokrovčkom (termoplastični elastomer).
English: In patients with uveitis, a loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab every other week starting at week 1, resulted in mean steady-state concentrations of approximately 8 to 10 μg/mL.
Slovenian: Pri bolnikih z uveitisom je uvajalni odmerek 80 mg adalimumaba v 0. tednu, ki mu je sledil odmerek 40 mg adalimumaba vsak drugi teden z začetkom v 1. tednu, povzročil srednjo koncentracijo v stanju dinamičnega ravnovesja približno 8 do 10 µg/ml.
English: SPARCC MRI Spine d,j a Assessment of Spondyloarthritis International Society b
Slovenian: SPARCC MRI hrbtenjače d,j
English: Adalimumab/methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see table 6).
Slovenian: Pri bolnikih, ki so dobivali adalimumab in metotreksat, je bilo po 6 in 12 mesecih (glejte preglednico 6) statistično značilno manj rentgenografskih znakov napredovanja kot pri bolnikih, ki so dobivali samo metotreksat.
English: SOLYMBIC 40 mg solution for injection in pre-filled pen EU/1/16/1163/006 - 1 pack
Slovenian: SOLYMBIC 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku EU/1/16/1163/006 - 1 peresnik
English: SOLYMBIC 40 mg solution for injection in pre-filled pen 0.8 mL solution for injection in pre-filled pen for patient use containing a pre-filled syringe (type I glass).
Slovenian: Zdravilo SOLYMBIC 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku 0,8 ml raztopine v napolnjenem injekcijskem peresniku za uporabo pri bolnikih, ki vsebuje napolnjeno injekcijsko brizgo (steklo tipa I).
English: CD study I and CD study II induction of remission and response rates are presented in table 17
Slovenian: Indukcijo remisije in deleže odziva v študiji pri Crohnovi bolezni I in študiji pri Crohnovi bolezni II prikazuje preglednica 17.
English: SOLYMBIC is used to treat psoriatic arthritis in adults.
Slovenian: Zdravilo SOLYMBIC se uporablja za zdravljenje psoriatičnega artritisa pri odraslih.
English: In case there is a need for a more rapid response to therapy, the regimen 80 mg at week 0 (dose can be administered as two injections in one day), 40 mg at week 2 can be used, with the awareness that the risk for adverse events may be higher with use of the higher induction dose.
Slovenian: Če je potreben hitrejši odgovor na zdravljenje, se lahko uporabi 80 mg 0. teden (odmerek se lahko da kot dve injekciji v enem dnevu) in 40 mg 2. teden, vendar se je potrebno zavedati, da je tveganje za neželene učinke lahko večje ob uporabi višjih uvodnih odmerkov.
English: A. Remove one SOLYMBIC pre-filled pen from the package.
Slovenian: A. Vzemite en napolnjen injekcijski peresnik zdravila SOLYMBIC iz škatle.
English: SOLYMBIC 40 mg solution for injection in pre-filled syringe 0.8 mL solution in pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a stainless steel needle with a needle shield (thermoplastic elastomer).
Slovenian: SOLYMBIC 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi 0,8 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z batno zaporko (bromobutilni kavčuk) in z iglo iz nerjavečega jekla z varovalnim pokrovčkom (termoplastični elastomer).
English: Glucocorticoids, salicylates, non-steroidal anti-inflammatory drugs, or analgesics can be continued during treatment with SOLYMBIC.
Slovenian: Med zdravljenjem z zdravilom SOLYMBIC je mogoče nadaljevati z uporabo glukokortikoidov, salicilatov, nesteroidnih protivnetnih zdravil ali analgetikov.
English: CD study I: infliximab naïve patients
Slovenian: Študija pri Crohnovi bolezni I: Bolniki, ki še niso dobivali infliksimaba
English: SOLYMBIC is used to treat moderate to severe plaque psoriasis in adults.
Slovenian: Zdravilo SOLYMBIC se uporablja za zdravljenje zmerne do hude luskavice (psoriaze) v plakih pri odraslih.
English: Do not use the 40 mg pre-filled pen for the 20 mg dose in children or adolescent weighing less than 40 kg with Crohn's disease.
Slovenian: Pri otrocih in mladostnikih, ki tehtajo manj kot 40 kg in imajo Crohnovo bolezen, za odmerek 20 mg ne uporabljajte 40 mg napolnjenega injekcijskega peresnika.
English: Uncommon side effects (may affect up to 1 in 100 people):
Slovenian: Občasni neželeni učinki (lahko prizadenejo do 1 od 100 bolnikov):
English: P Value b
Slovenian: Vrednost b
English: Some patients who experience decrease in their response may benefit from an increase in dosing frequency to 40 mg SOLYMBIC every week.
Slovenian: Nekaterim bolnikom, ki se jim odziv zmanjša, lahko koristi povečanje pogostnosti odmerjanja zdravila SOLYMBIC na 40 mg vsak teden.
English: Do not use the 20 mg or 40 mg pre-filled syringe if doses other than 20 mg or 40 mg are recommended.
Slovenian: • Če sta priporočena odmerka drugačna od 20 mg ali 40 mg, ne uporabljajte 20 mg ali 40 mg napolnjenih injekcijskih brizg.
English: The usual dose regimen is 80 mg initially followed by 40 mg two weeks later.
Slovenian: Običajni začetni odmerek je 80 mg, ki mu sledi 40 mg dva tedna kasneje.
English: In patients with hidradenitis suppurativa, a dose of 160 mg adalimumab on week 0 followed by 80 mg on week 2 achieved serum adalimumab trough concentrations of approximately 7 to 8 μg/mL at week 2 and week 4.
Slovenian: Pri bolnikih s hidradenitis suppurativa doseže odmerek 160 mg adalimumaba na 0. teden, ki mu sledi 80 mg adalimumaba 2. teden, najnižjo koncentracijo adalimubaba v serumu pred naslednjim odmerkom približno 7 do 8 µg/ml v 2. tednu in v 4. tednu.
English: The recommended SOLYMBIC dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at day 15 (given as two 40 mg injections in one day).
Slovenian: Priporočena shema odmerjanja zdravila SOLYMBIC pri odraslih bolnikih s hidradenitis suppurativa (HS) je 160 mg na 1. dan (apliciran v obliki štirih 40 mg injiciranj na dan ali z dvema 40 mg injiciranjema na dan dva dni zapored), ki mu sledi 80 mg dva tedna kasneje na 15. dan (apliciran v obliki dveh 40 mg injiciranj v enem dnevu).
English: SOLYMBIC 40 mg pen
Slovenian: SOLYMBIC 40 mg brizga
English: There have been cases of cancers other than lymphoma in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker.
Slovenian: • Pri bolnikih s posebno boleznijo pljuč, t.i. kronično obstruktivno pljučno boleznijo (KOPB), zdravljenih z nekim drugim zaviralcem TNF, so bili primeri rakov, ki niso bili limfomi.
English: SOLYMBIC 40 mg injection adalimumab
Slovenian: SOLYMBIC 40 mg injekcija adalimumab s.c.
English: Uncommon Erectile dysfunction
Slovenian: Motnje reprodukcije in dojk erektilna disfunkcija
English: SOLYMBIC is used to treat ulcerative colitis in adults.
Slovenian: Zdravilo SOLYMBIC se uporablja za zdravljenje ulceroznega kolitisa pri odraslih.
English: All patients, and in particular patients with a medical history of extensive immunosuppressant therapy or psoriasis patients with a history of PUVA treatment should be examined for the presence of nonmelanoma skin cancer prior to and during treatment with SOLYMBIC.
Slovenian: Pred zdravljenjem z zdravilom SOLYMBIC in med zdravljenjem z njim je treba za nemelanomskega kožnega raka pregledati vse bolnike, še zlasti pa bolnike z anamnezo intenzivne imunosupresivne terapije in bolnike s psoriazo, ki so kdaj prejemali PUVA.
English: Haematoma
Slovenian: Imunogenost
English: SOLYMBIC 20 mg injection adalimumab
Slovenian: SOLYMBIC 20 mg injekcija adalimumab s.c.
English: Each pack contains 1, 2, 4, or 6 single use SureClick pre-filled pens.
Slovenian: Eno pakiranje vsebuje 1, 2, 4 ali 6 40 mg napolnjenih injekcijskih peresnikov.
English: Table 14 Paediatric plaque psoriasis efficacy results at 16 weeks
Slovenian: Rezultati učinkovitosti v 16. tednu pri pediatričnih bolnikih s psoriazo v plakih
English: bruise or bleed very easily or look very pale, call your doctor right away.
Slovenian: Če dobite zvišano telesno temperaturo, ki ne mine, če se vam pojavljajo podplutbe, zlahka zakrvavite ali ste zelo bledi, se takoj posvetujte s svojim zdravnikom.
English: Do not use the 40 mg pre-filled pen if doses other than 40 mg are recommended.
Slovenian: • Če sta priporočena odmerka drugačna od 40 mg, ne uporabljajte 40 mg napolnjenih injekcijskih peresnikov.
English: The usual SOLYMBIC dose for adults with ulcerative colitis is 160 mg initially (dose can be administered as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg two weeks later, then 40 mg every other week.
Slovenian: Običajen odmerek zdravila SOLYMBIC pri odraslih z ulceroznim kolitisom je 160 mg na začetku (odmerek je lahko štiri 40 mg injekcije v enem dnevu ali po dve 40 mg injekciji na dan dva zaporedna dneva), ki mu sledi 80 mg dva tedna kasneje, nato pa 40 mg vsak drugi teden.
English: Patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as non-responders
Slovenian: Bolniki z vsaj delnim odzivom na odmerek 40 mg adalimumaba po 12. tednih zdravljenja b Bolniki, ki izpolnjujejo merila, določena v protokolu za izgubo odziva ali pri njih ni bilo izboljšanja, so bili izključeni iz študij in so se šteli kot bolniki brez odgovora (“nonresponders”)
English: The needle cover of the pre-filled syringe or pen is made from dry natural rubber (a derivative of latex), which may cause allergic reactions.
Slovenian: Pokrovček igle na napolnjeni injekcijski brizgi ali pereseniku vsebuje suho naravno gumo (derivat lateksa), ki lahko povzroči alergijske reakcije.
English: SOLYMBIC single use SureClick pre-filled pen For subcutaneous use
Slovenian: SOLYMBIC napolnjen injekcijski peresnik SureClick za enkratno uporabo Za subkutano uporabo.
English: Very common Leucopaenia (including neutropaenia and agranulocytosis), Anaemia
Slovenian: zelo pogosti levkopenija (vključno z nevtropenijo in agranulocitozo), anemija levkocitoza, trombocitopenija idiopatska trombocitopenična purpura pancitopenija
English: The recommended SOLYMBIC induction dose regimen for paediatric subjects with severe Crohn's disease is 40 mg at week 0 followed by 20 mg at week 2.
Slovenian: Priporočeni uvodni odmerek zdravila SOLYMBIC pri pediatričnih bolnikih s hudo Crohnovo boleznijo je 40 mg 0. teden, ki mu sledi 20 mg 2. teden.
English: 2 pre-filled syringes.
Slovenian: 2 napolnjena injekcijska peresnika.
English: Table 12 Ps study II (CHAMPION) efficacy results at 16 weeks
Slovenian: Študija pri psoriazi II (CHAMPION) - Rezultati učinkovitosti po 16 tednih placebo N = 53 n (%)
English: In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), 80 mg at week 2 can be used, with the awareness that the risk for adverse events may be higher with use of the higher induction dose.
Slovenian: Če je potreben hitrejši odgovor na zdravljenje, se lahko uporabi 160 mg 0. teden (odmerek se lahko odmeri kot štiri injekcije v enem dnevu ali kot dve injekciji v enem dnevu dva zaporedna dneva) in 80 mg 2. teden, vendar se je potrebno zavedati, da je tveganje za neželene učinke lahko večje ob uporabi višjih uvodnih odmerkov.
English: SOLYMBIC 20 mg solution for injection in pre-filled syringe Each single dose pre-filled syringe contains 20 mg of adalimumab in 0.4 mL (50 mg/mL) solution.
Slovenian: SOLYMBIC 20 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga z enim odmerkom vsebuje 20 mg adalimumaba v 0,4 ml (50 mg/ml) raztopine.
English: Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye. SOLYMBIC is used to treat adults with non-infectious uveitis with inflammation affecting the back of the eye.
Slovenian: Zdravilo SOLYMBIC se uporablja za zdravljenje pri odraslih z neinfekcijskim uveitisom, tj. vnetjem, ki prizadene zadnji del očesa.
English: 6 pre-filled syringes.
Slovenian: 6 napolnjenih injekcijskih brizg.
English: The needle cover of the pre-filled syringe is made from dry natural rubber (a derivative of latex), which may cause allergic reactions.
Slovenian: Pokrovček igle na napolnjeni injekcijski brizgi vsebuje suho naravno gumo (derivat lateksa), ki lahko povzroči alergijske reakcije.
English: Vertigo and visual impairment may occur following administration of SOLYMBIC (see section 4.8).
Slovenian: Po dajanju zdravila SOLYMBIC se lahko pojavita vrtoglavica in poslabšanje vida (glejte poglavje 4.8).
English: All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias
Slovenian: Vsem bolnikom je treba naročiti, naj nemudoma poiščejo zdravniško pomoč, če se jim med uporabo zdravila SOLYMBIC pojavijo znaki ali simptomi krvnih diskrazij (npr. trajno zvišana telesna temperatura, podplutbe, krvavitve, bledica).
English: SOLYMBIC 40 mg solution for injection in pre-filled pen (SureClick) Solution for injection.
Slovenian: SOLYMBIC 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku (SureClick) raztopina za injiciranje
English: The recommended SOLYMBIC induction dose regimen for paediatric subjects with severe Crohn's disease is 80 mg at week 0 followed by 40 mg at week 2.
Slovenian: Priporočeni uvodni odmerek zdravila SOLYMBIC pri pediatričnih bolnikih s hudo Crohnovo boleznijo je 80 mg 0. teden, ki mu sledi 40 mg 2. teden.
English: Not applicable, SOLYMBIC is only available as 20 mg and 40 mg pre-filled syringe and 40 mg pre-filled pen
Slovenian: Ni primerno, zdravilo SOLYMBIC je na voljo le kot 20 mg in 40 mg napolnjena injekcijska brizga in kot 40 mg napolnjen injekcijski peresnik
English: The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose.
Slovenian: Običajni začetni odmerek za odrasle z neinfekcijskim uveitisom je 80 mg, čemur sledi odmerek 40 mg, ki se ga daje vsak drugi teden, z začetkom en teden po začetnem odmerku.
English: In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with SOLYMBIC should be considered prior to initiating therapy (see Other opportunistic infections).
Slovenian: Pred začetkom zdravljenja je treba tveganja in koristi zdravljenja z zdravilom SOLYMBIC pretehtati pri bolnikih, ki so bili izpostavljeni tuberkulozi, in bolnikih, ki so potovali na območja, kjer obstaja veliko tveganje tuberkuloze ali endemičnih mikoz, npr. histoplazmoze, kokcidioidomikoze ali blastomikoze (glejte Oportunistične okužbe).
English: System Organ Class Frequency Adverse Reaction Infections and infestations*
Slovenian: Infekcijske in parazitske bolezni*
English: J. Discard the used syringe and the needle cap.
Slovenian: J. Uporabljeno brizgo in pokrovček igle odvrzite.
English: If a faster response is required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in 1 day or as two 40 mg injections per day for 2 consecutive days) followed by 80 mg two weeks later.
Slovenian: Če je potreben hitrejši odziv, lahko zdravnik predpiše začetni odmerek 160 mg (kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva zaporedna dneva), ki mu sledi 80 mg dva tedna kasneje.
English: The recommended dose of SOLYMBIC for patients aged 4 to 17 years with plaque psoriasis depends on the weight of your child. SOLYMBIC should only be used in patients weighing either 23 to 28 kg or 47 kg and greater.
Slovenian: Zdravilo SOLYMBIC se lahko uporablja le pri bolnikih, ki tehtajo ali od 23 do 28 kg ali 47 kg in več.
English: Depending on your response, your doctor may increase the dose to 40 mg every week.
Slovenian: Glede na vaš odziv lahko zdravnik poveča odmerek na 40 mg vsak teden.
English: Discontinuation of SOLYMBIC therapy should be considered in patients with confirmed significant haematologic abnormalities.
Slovenian: Pri bolnikih s potrjenimi pomembnimi hematološkimi nepravilnostmi je treba razmisliti o prekinitvi terapije z zdravilom SOLYMBIC.
English: There is no relevant use of adalimumab in children aged below 12 years in this indication.
Slovenian: Uporaba adalimumaba pri otrocih, starih manj kot 12 let, v tej indikaciji ni primerna.
English: If a faster response is required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later, and thereafter as 40 mg every other week.
Slovenian: Če je potreben hitrejši odziv, vam zdravnik lahko predpiše začetni odmerek 160 mg (v štirih 40 mg injekcijah na en dan ali v dveh 40 mg injekcijah dva dni zapored), ki mu sledi 80 mg dva tedna kasneje in potem 40 mg vsak drugi teden.
English: SOLYMBIC is only available as 20 mg and 40 mg pre-filled syringe and 40 mg pre-filled pen.
Slovenian: Zdravilo SOLYMBIC je na voljo le kot 20 mg in 40 mg napolnjena injekcijska brizga in kot 40 mg napolnjen injekcijski peresnik.
English: 46.6a
Slovenian: 24. teden 36. teden a
English: SOLYMBIC is contraindicated in moderate to severe heart failure (see section 4.3).
Slovenian: Pri bolnikih z zmernim ali hudim srčnim popuščanjem je zdravilo SOLYMBIC kontraindicirano (glejte poglavje 4.3).
English: Bruising (including purpura), Dermatitis (including eczema), Onychoclasis,
Slovenian: pogosti poslabšanje ali pojav psoriaze (vključno s palmplantarno pustularno psoriazo) urtikarija, modrice (vključno s purpuro), dermatitis (vključno z ekcemom), oniholiza, čezmerno znojenje, alopecija srbenje
English: LABEL PRE-FILLED SYRINGE
Slovenian: ŠKATLA ZA NAPOLNJENO INJEKCIJSKO BRIZGO
English: Depending on your response, your doctor may increase the dose frequency to 40 mg every week.
Slovenian: Odvisno od vašega odziva lahko zdravnik poveča pogostnost odmerjanja na 40 mg vsak teden.
English: Some subjects who experience insufficient response may benefit from an increase in dosing frequency to 20 mg SOLYMBIC every week.
Slovenian: Pri bolnikih, ki se ne odzovejo zadostno, se lahko poveča pogostnost odmerjanja na 20 mg zdravila SOLYMBIC vsak teden.
English: There is no relevant use of adalimumab in children aged less than 6 years in this indication.
Slovenian: Uporaba adalimumaba pri otrocih, starih manj kot 6 let, v tej indikaciji ni primerna.
English: SOLYMBIC 20 mg solution for injection in pre-filled syringe SOLYMBIC 40 mg solution for injection in pre-filled syringe adalimumab
Slovenian: SOLYMBIC 20 mg raztopina za injiciranje v napolnjeni injekcijski brizgi SOLYMBIC 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi adalimumab
English: There is no relevant use of adalimumab in children aged less than 4 years in this indication.
Slovenian: Uporaba adalimumaba pri otrocih, starih manj kot 4 leta, v tej indikaciji ni primerna.
English: SOLYMBIC should be used with caution in patients with mild heart failure (NYHA class I/II).
Slovenian: Pri bolnikih z blagim srčnim popuščanjem (razred I/II po NYHA) je treba zdravilo SOLYMBIC uporabljati previdno.
English: How to store SOLYMBIC
Slovenian: Shranjevanje zdravila SOLYMBIC