FrancophonIA/ELRC3.0 huggingface dataset:
English: 88 and 189 patients, respectively, continued to be in clinical remission.
Slovenian: 88 bolnikov iz študije Crohnove bolezni I in 189 bolnikov iz študij Crohnove bolezni II in III je bilo še naprej v klinični remisiji.
English: • Certain vaccines contain living but weakened forms of disease-causing bacteria or viruses and should not be given during treatment with Kromeya in case they cause infections.
Slovenian: • Določena cepiva lahko vsebujejo ţive ampak oslabljene oblike povzročitelja bolezni (bakterije ali viruse), zato se jih v primerih, ko lahko povzročijo okuţbo, ne sme dajati med zdravljenjem z zdravilom Kromeya.
English: Table 18 Paediatric CD study PCDAI clinical remission and response
Slovenian: Preglednica 18 Študija Crohnove bolezni pri pediatričnih bolnikih PCDAI klinična remisija in odziv Standardni odmerek
English: In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see Table 12).
Slovenian: V študiji revmatoidnega artritisa V so strukturno okvaro sklepov ocenili rentgenografsko in jo izrazili kot razliko v modificirani celotni Sharpovi oceni (glejte preglednico 12).
English: • If your child experiences allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Kromeya and contact your doctor immediately since, in rare cases, these reactions can be life threatening.
Slovenian: • Če vaš otrok doţivi alergijske reakcije s simptomi, kot so tiščanje v prsih, piskajoče dihanje, omotica, otekanje ali izpuščaj, zdravila Kromeya ne injicirajte več in se takoj posvetujte s svojim zdravnikom, saj so v redkih primerih te reakcije lahko ţivljenje ogroţajoče.
English: Once removed from the refrigerator for room temperature storage, your pre-filled syringe must be used within 14 days or discarded, even if it is later returned to the refrigerator.
Slovenian: Ko ga enkrat, namesto v hladilniku, shranjujete pri sobni temperaturi, morate napolnjen injekcijski peresnik porabiti v 14 dneh ali pa zavreči, tudi če ga vrnete v hladilnik.
English: Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Slovenian: Poliartikularni juvenilni idiopatski artritis in artritis, povezan z entezitisom
English: 20 mg every other week
Slovenian: 20 mg vsak drugi teden
English: At week 16, more patients randomised to adalimmab 0.8 mg/kg had positive efficacy responses (e.g. PASI 75) than those randomised to 0.4 mg/kg eow or MTX.
Slovenian: V 16. tednu se je več bolnikov, ki so bili randomizirani na adalimumab 0,8 mg/kg, pozitivno odzvalo v smislu učinkovitosti (npr. PASI 75) kot tistih, ki so bili randomizirani na odmerek 0,4 mg/kg vsak drugi teden ali metotreksat.
English: ***, ** Statistically significant at p < 0.001 and < 0.01, respectively, for all comparisons between adalimumab and placebo.
Slovenian: ***, ** Statistično značilno s p < 0,001 in < 0,01 (v tem zaporedju) za vse primerjave med adalimumabom in placebom.
English: The reported rates for non-melanoma skin cancers and lymphomas are approximately 0.2 and 0.3 per 1,000 patient treatment years, respectively (see section 4.4).
Slovenian: Ugotovljeni deleţ nemelanomskih rakov je pribliţno 0,2 na 1000 bolnikov-let zdravljenja in limfomov pribliţno 0,3 na 1000 bolnikov-let zdravljenja(glejte poglavje 4.4).
English: Time to treatment failure at or after week 2 in study UV II Primary analysis (ITT)
Slovenian: Čas do neuspeha zdravljenja v ali po 2. tednu v študiji UV II Primarna analiza (ITT)
English: • If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Kromeya and contact your doctor immediately since, in rare cases, these reactions can be life threatening.
Slovenian: • Če imate alergijsko reakcijo s simptomi, kot so tiščanje v prsih, piskajoče dihanje, omotica, otekanje ali izpuščaj, zdravila Kromeya ne injicirajte več in se takoj posvetujte s svojim zdravnikom, saj so v redkih primerih te reakcije lahko ţivljenje ogroţajoče.
English: Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with adalimumab Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with adalimumab.
Slovenian: Kljub profilaktičnemu zdravljenju za tuberkulozo, so se pri bolnikih, zdravljenih z adalimumabom, pojavili primeri reaktivacije tuberkuloze.
English: • difficulty sleeping;
Slovenian: • oteţkočeno spanje;
English: The recommended dose of Kromeya for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Slovenian: Priporočeni odmerek zdravila Kromeya za odrasle bolnike z revmatoidnim artritisom je 40 mg adalimumaba vsak drugi teden v enkratnem odmerku v subkutani injekciji.
English: Warning: Do not warm the kit any other way, such as in a microwave, hot water, or direct sunlight.
Slovenian: Opozorilo: Kompleta ne smete ogreti na noben drug način, na primer v mikrovalovni pečici, vroči vodi ali na neposredni sončni svetlobi.
English: PGA: Clear/minimal c a
Slovenian: PGA: čisto/minimalno c a
English: Patients were randomised to receive either 24 mg/m2 body surface area (BSA) of adalimumab up to a maximum of 40 mg, or placebo every other week for 12 weeks.
Slovenian: Bolniki so bili randomizirani za prejemanje bodisi 24 mg/m telesne površine adalimumaba do največjega posamičnega odmerka 40 mg ali placebo vsak drugi teden, 12 tednov.
English: At week 4, subjects were randomised 1:1 based on their body weight at the time to either the Low Dose or Standard Dose maintenance regimens as shown in Table 17.
Slovenian: V 4. tednu so bili bolniki glede na njihovo telesno maso v tem času randomizirani v razmerju1:1 bodisi v vzdrţevalni reţim z majhnim odmerkom ali vzdrţevalni reţim s standardnim odmerkom, kot kaţe preglednica 17.
English: Among those, 48 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less.
Slovenian: Med temi bolniki jih 48 ni kazalo napredovanja strukturne prizadetosti izraţene s spremembo srednje celotne Sharpove ocene 0,5 ali manj od začetka študije.
English: Table 24 Paediatric CD study PCDAI clinical remission and response
Slovenian: Preglednica 24 Študija Crohnove bolezni pri pediatričnih bolnikih PCDAI klinična remisija in odziv Standardni odmerek
English: Sustained response
Slovenian: Ohranjen odziv
English: 10 kg to < 30 kg
Slovenian: 10 kg do < 30 kg
English: Among those, 86 patients (75.4%) had ACR 20 responses; 72 patients (63.2%) had ACR 50 responses; and 41 patients (36%) had ACR 70 responses.
Slovenian: Med temi je 86 bolnikov (75,4 %) imelo odziv 20 po ACR; 72 bolnikov (63,2 %) je imelo odziv 50 po ACR; in 41 bolnikov (36 %) je imelo odziv 70 po ACR.
English: Warning: Do not throw away the syringe in your household trash.
Slovenian: Opozorilo: Injekcijske brizge ne zavrzite med gospodinjske odpadke.
English: Rare (may affect up to 1 in 1,000 people)
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
English: • Do not insert your fingers into the opening of the clear needle guard.
Slovenian: • Ne dajajte prstov v reţo na prozornem varovalu za injekcijsko iglo.
English: Be sure that you read, understand, and follow these Instructions for Use before injecting Kromeya.
Slovenian: Pred injiciranjem zdravila Kromeya, bodite prepričani, da ste prebrali, razumeli in sledili tem Navodilom za uporabo.
English: Kromeya is recommended for use in combination with methotrexate.
Slovenian: Priporoča se kombinirana uporaba zdravila Kromeya z metotreksatom.
English: In controlled trials of adalimumab (initial doses of 160 mg at week 0 and 80 mg at week 2, followed by 40 mg every week starting at week 4), in patients with hidradenitis suppurativa with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥ 3 x ULN occurred in 0.3% of adalimumab-treated patients and 0.6% of control-treated patients.
Slovenian: V kontroliranih preskušanjih z adalimumabom (v začetnem odmerku 160 mg v tednu 0, ki mu sledi odmerek 80 mg v 2. tednu in potem 40 mg vsak teden z začetkom v 4. tednu) pri bolnikih s hidradenitis suppurativa in s trajanjem kontrolnega obdobja od 12 do 16 tednov, se je zvišanje ALT ≥ 3 x ULN pojavilo pri 0,3 % bolnikov, zdravljenih z adalimumabom, in pri 0,6 % bolnikov v kontrolni skupini.
English: Adult Crohn's disease
Slovenian: Crohnova bolezen pri odraslih
English: There is no relevant use of Kromeya in children aged less than 2 years in this indication.
Slovenian: Uporaba zdravila Kromeya pri otrocih, mlajših od 2 let, za to indikacijo ni primerna.
English: Initial dose of 40 mg, followed by 40 mg one week later.
Slovenian: Začetni odmerek 40 mg, ki mu sledi 40 mg en teden kasneje.
English: Kromeya is used to treat rheumatoid arthritis in adults.
Slovenian: Zdravilo Kromeya se uporablja za zdravljenje revmatoidnega artritisa pri odraslih.
English: • rheumatoid arthritis,
Slovenian: • revmatoidni artritis,
English: • If you have or develop demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Kromeya.
Slovenian: • Če imate ali pa se pri vas razvija demielinizirajoča bolezen (bolezen, ki vpliva na izolacijsko plast okoli ţivcev, kot je multipla skleroza), bo zdravnik presodil, ali lahko dobivate oziroma tudi še nadalje dobivate zdravilo Kromeya.
English: • Tell your doctor if your child has lived or travelled in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are common.
Slovenian: • Zdravniku morate povedati, če je vaš otrok ţivel ali je potoval v predele, kjer so pogoste glivične okuţbe, npr. histoplazmoza, kokcidioidomikoza ali blastomikoza.
English: Adalimumab has not been studied in these patient populations.
Slovenian: Adalimumab pri teh populacijah bolnikov še ni bil preskušen, zato priporočil za odmerjanje ni mogoče dati.
English: Initial dose of 40 mg, followed by 20 mg two weeks later.
Slovenian: Začetni odmerek je 40 mg, ki mu sledi 20 mg dva tedna kasneje.
English: The rate (95% confidence interval) of nonmelanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient-years among adalimumab-treated patients and 3.2 (1.3, 7.6) per 1,000 patient-years among control patients.
Slovenian: Deleţ (95 % interval zaupanja) nemelanomskih koţnih rakov je bil 8,8 (6,0; 13,0) na 1000 bolnikov-let med bolniki, ki so dobivali adalimumab, in 3,2 (1,3; 7,6) na 1000 bolnikov-let med kontrolnimi bolniki.
English: - Your doctor will also give you a patient reminder card, which contains important safety information that you need to be aware of before you are given Kromeya and during treatment with Kromeya.
Slovenian: Ta vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni, preden prejmete zdravilo Kromeya in med zdravljenjem z njim.
English: Always use this medicine exactly as your child's doctor or pharmacist has instructed.
Slovenian: Pri uporabi tega zdravila natančno upoštevajte navodila otrokovega zdravnika ali farmacevta .
English: Warning: Do not warm the syringe any other way, such as in a microwave, hot water, or direct sunlight.
Slovenian: Opozorilo: Injekcijske brizge ne smete ogreti na noben drug način, na primer v mikrovalovni pečici, vroči vodi ali na neposredni sončni svetlobi.
English: Patients received placebo, an initial dose of MTX 7.5 mg and thereafter dose increases up to week 12, with a maximum dose of 25 mg or an initial dose of 80 mg adalimumab followed by 40 mg every other week (starting one week after the initial dose) for 16 weeks.
Slovenian: Bolniki so dobivali placebo, začetni odmerek 7,5 mg metotreksata z nadaljnjim povečanjem odmerka do 12. tedna; do največjega odmerka 25 mg, ali začetni odmerek 80 mg adalimumaba in potem 40 mg vsak drugi teden (začenši en teden po začetnem odmerku) 16 tednov.
English: In CD study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg adalimumab at week 0 and 80 mg at week 2 or placebo at weeks 0 and 2.
Slovenian: V študiji Crohnove bolezni II je bilo 325 bolnikov, ki so postali neodzivni ali so imeli intoleranco na infliksimab, randomiziranih, da so prejeli ali 160 mg adalimumaba v 0. tednu in 80 mg v 2. tednu ali placebo v 0. in 2. tednu.
English: • Store the Kromeya Vial Kit in its original box to protect it from light.
Slovenian: • Zdravilo Kromeya komplet z vialo shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: The recommended Kromeya induction dose regimen for adult patients with moderate to severe ulcerative colitis is 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) and 80 mg at week 2 (given as two 40 mg injections in one day).
Slovenian: Priporočena shema odmerjanja zdravila Kromeya med indukcijo je pri odraslih bolnikih z zmerno do hudo aktivnim ulceroznim kolitisom 160 mg 0. teden (aplicirano kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva dni zapored) in 80 mg 2. teden (aplicirano kot dve 40 mg injekciji v enem dnevu).
English: Warning: Keep your sharps disposal container out of the reach of children.
Slovenian: Opozorilo: Zbiralnik za ostre predmete shranjujte nedosegljiv otrokom.
English: Adalimumab was evaluated in over 3000 patients in all rheumatoid arthritis clinical trials.
Slovenian: V vseh kliničnih preskušanjih revmatoidnega artritisa (RA) so adalimumab ocenili pri več kot 3000 bolnikih.
English: The safety and efficacy of adalimumab were also studied in adult patients with moderate to severe chronic plaque psoriasis with concomitant hand and/or foot psoriasis who were candidates for systemic therapy in a randomised double-blind study (Psoriasis study III).
Slovenian: Varnost in učinkovitost adalimumaba so raziskali tudi v randomizirani dvojno slepi študiji pri odraslih bolnikih z zmerno do hudo kronično psoriazo v plakih s sočasno psoriazo na dlaneh in/ali stopalih, ki so bili kandidati za sistemsko zdravljenje (Študija pri psoriazi III).
English: If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your doctor immediately.
Slovenian: Če se med zdravljenjem ali po njem pojavijo simptomi tuberkuloze (trdovraten kašelj, hujšanje, brezvoljnost, rahlo zvišana telesna temperatura) ali kakšne druge okuţbe, to takoj povejte zdravniku.
English: • The needle guard spring is not extended (Figure I).
Slovenian: • vzmet varovala za injekcijsko iglo ni raztegnjena (Slika I).
English: Analysis treatment
Slovenian: Analiza
English: 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 Spondyloarthritis Research Consortium of Canada i n=84 placebo and adalimumab j n=82 placebo and n=85 adalimumab
Slovenian: 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)
English: Respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral)
Slovenian: zelo pogosti okuţbe respiratornega trakta (vključno z okuţbo spodnjega in zgornjega respiratornega trakta, pljučnico, vnetjem sinusa, vnetjem sluznice ţrela, vnetjem nosnega dela ţrela in pljučnim virusnim herpesom)
English: 3.2 Hold the vial adapter, insert the syringe tip into it and screw to connect.
Slovenian: 3.2 Primite nastavek za vialo, vanj vstavite konico injekcijske brizge in jo privijte, da se pritrdi.
English: • vertigo (sensation of room spinning);
Slovenian: • vrtoglavica (občutek vrtenja v prostoru);
English: If your child received Kromeya during her pregnancy, her baby may have a higher risk for getting an infection.
Slovenian: Če je vaš otrok prejemal zdravilo Kromeya med nosečnostjo, obstaja večje tveganje, da bo njegov dojenček dobil okuţbo.
English: If a faster response is required, your child's doctor may prescribe an initial dose of 80 mg (as two 40 mg injections in one day) followed by 40 mg two weeks later.
Slovenian: Če je potreben hitrejši odziv, lahko zdravnik vašega otroka predpiše začetni odmerek 80 mg (kot dve 40 mg injekciji v enem dnevu), ki mu sledi 40 mg dva tedna kasneje.
English: 2.6 Peel off the paper from the vial adapter packaging without taking the vial adaptor out of its packaging.
Slovenian: 2.6 Z ovojnine nastavka za vialo odstranite papir, ne da bi nastavek vzeli iz ovojnine.
English: Warning: Do not rub the injection site.
Slovenian: Opozorilo: Mesta injiciranja ne drgnite.
English: In controlled Phase 3 trials of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations ≥ 3 x ULN occurred in 6.1% of adalimumab-treated patients and 1.3% of control-treated patients.
Slovenian: V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih z juvenilnim idiopatskim artritisom, ki so bili stari od 4 do 17 let in bolnikih z artritisom, povezanim z entezitisom, ki so bili stari od 6 do 17 let, so se zvišanja ALT ≥ 3 x ULN pojavila pri 6,1 % bolnikov zdravljenih z adalimumabom, in pri 1,3 % bolnikov v kontrolni skupini.
English: You should record the date when the vial is first removed from refrigerator, and the date after which it should be discarded.
Slovenian: Zapisati si morate datum, ko je bila viala vzeta iz hladilnika in datum, po katerem jo je potrebno zavreči.
English: Single use pre-filled syringe (adalimumab) for subcutaneous injection 40mg
Slovenian: Napolnjen injekcijski peresnik (adalimumab) za subkutano injiciranje 40 mg
English: Contact your doctor if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.
Slovenian: Obvestite svojega zdravnika, če se pojavijo simptomi, kot so vztrajen nepojasnjen izpuščaj, zvišana telesna temperatura, bolečine v sklepih ali utrujenost.
English: Warning: Do not inject into an area that is sore (tender), bruised, red, hard, scarred or where you have stretch marks.
Slovenian: Opozorilo: Zdravila ne smete injicirati v predel, ki je boleč (občutljiv), podplut, pordel, otrdel ali ki ima brazgotine ali strije.
English: Clinical response (CR-100) Patients in steroid-free remission for >=90 days a
Slovenian: Klinična remisija Klinični odziv (CR-100) Bolniki v remisiji brez steroidov 5 % (3/66) za ≥ 90 dni a
English: • Store the Kromeya Vial Kit in a refrigerator between 2°C to 8°C.
Slovenian: • Zdravilo Kromeya komplet z vialo shranjujte v hladilniku pri temperaturi med 2 °C in 8 °C.
English: Among those, 64 patients (79.0%) had ACR 20 responses; 56 patients (69.1%) had ACR 50 responses; and 43 patients (53.1%) had ACR 70 responses.
Slovenian: Med temi je 64 bolnikov (79,0 %) imelo odziv 20 po ACR; 56 bolnikov (69,1 %) je imelo odziv 50 po ACR; in 43 bolnikov (53,1 %) je imelo odziv 70 po ACR.
English: • If you have an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting Kromeya.
Slovenian: • Če imate kakšno okuţbo, vključno z dolgotrajno ali omejeno okuţbo (npr. razjedo na nogi), se pred uporabo zdravila Kromeya posvetujte s svojim zdravnikom.
English: Do not use this medicine after the expiry date which is stated on the label/ carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki/škatli poleg oznake “EXP”.
English: 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 23.
Slovenian: V 4. tednu so bili bolniki glede na njihovo telesno maso v tem času randomizirani v razmerju 1:1 bodisi v vzdrţevalni reţim z majhnim odmerkom ali vzdrţevalni reţim s standardnim odmerkom, kot kaţe preglednica 23.
English: Table 12 Ped ACR 30 responses in the JIA study
Slovenian: Preglednica 12 Odzivi »Ped ACR« 30 v študiji pri juvenilnem idiopatskem artritisu
English: A 40 mg pre-filled syringe and a 40 mg prefilled pen are also available for use.
Slovenian: Za uporabo sta na voljo tudi 40 mg napolnjena injekcijska brizga in 40 mg napolnjen injekcijski peresnik.
English: Figure I Warning: Do not use the syringe if it shows any sign of damage.
Slovenian: Opozorilo: Injekcijske brizge ne uporabljajte, če je kakorkoli poškodovana.
English: Kromeya dose for paediatric patients with plaque psoriasis
Slovenian: Odmerjanje zdravila Kromeya pri pediatričnih bolnikih s psoriazo v plakih
English: • If your child has an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting Kromeya.
Slovenian: • Če ima vaš otrok kakšno okuţbo, vključno z dolgotrajno ali omejeno okuţbo (npr. razjedo na nogi), se pred uporabo zdravila Kromeya posvetujte s svojim zdravnikom.
English: Adalimumab n=274
Slovenian: Adalimuma b n = 274
English: Crohn's disease is an inflammatory disease of the gut.
Slovenian: Crohnova bolezen je vnetna bolezen prebavil.
English: In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see Table 10).
Slovenian: V študiji revmatoidnega artritisa V so strukturno okvaro sklepov ocenili rentgenografsko in jo izrazili kot razliko v modificirani celotni Sharpovi oceni (glejte preglednico 10).
English: • Do not use an Kromeya pre-filled syringe that has been frozen or left in direct sunlight.
Slovenian: • Zdravila Kromeya napolnjena injekcijska brizga ne uporabljajte, če je bila brizga zamrznjena ali dlje časa izpostavljena neposredni sončni svetlobi.
English: Beyond 16 weeks, patients with inadequate response to Kromeya 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week.
Slovenian: Od 16. tedna dalje lahko bolnikom z nezadostnim odzivom na zdravilo Kromeya 40 mg vsak drugi teden koristi povečanje odmerka na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: • lichenoid skin reaction (itchy reddish-purple skin rash).
Slovenian: • lihenoidna reakcija koţe (srbeč rdeče-vijolični koţni izpuščaj).
English: Kromeya dose for patients with enthesitis-related arthritis
Slovenian: Odmerjanje zdravila Kromeya pri bolnikih z artritisom, povezanim z entezitisom
English: No ALT elevations ≥3 X ULN occurred in the Phase 3 trial of adalimumab in paediatric patients with plaque psoriasis.
Slovenian: Do nobenih zvišanj ALT ≥ 3 x ULN ni prišlo v preskušanju faze 3 z adalimumabom pri pediatričnih bolnikih s psoriazo v plakih.
English: 2 April 2019
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM 2. april 2019
English: Carriers of HBV who require treatment with Kromeya should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Slovenian: Nosilce HBV, ki potrebujejo zdravljenje z zdravilom Kromeya, je treba ves čas zdravljenja in več mesecev po koncu zdravljenja natančno spremljati glede znakov in simptomov aktivne okuţbe s HBV. O zdravljenju nosilcev HBV s protivirusno terapijo v kombinaciji z antagonistom TNF za preprečitev reaktivacije HBV ni zadostnih podatkov.
English: Kromeya 40 mg/0.8 mL solution for injection for paediatric use is supplied in a glass vial.
Slovenian: Kromeya 40 mg/0,8 ml raztopina za injiciranje za pediatrično uporabo je na voljo v stekleni viali.
English: Rare post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with adalimumab (see section 4.4).
Slovenian: V redkih primerih med obdobjem trţenja so pri bolnikih, zdravljenih z adalimumabom, poročali o hepatospleničnem limfomu celic T (glejte poglavje 4.4).