FrancophonIA/ELRC3.0 huggingface dataset:
English: At week 16, a statistically significantly greater proportion of patients who received adalimumab achieved PGA of 'clear' or 'almost clear' for the hands and/or feet compared to patients who received placebo (30.6% versus 4.3 %, respectively [P = 0.014]).
Slovenian: V 16. tednu je statistično pomembno večji delež bolnikov, ki so prejemali adalimumab, doseglo PGA ‘'čisto'' ali ‘'skoraj čisto'' za dlani in/ali stopala, v primerjavi z bolniki, ki so prejemali placebo
English: Hefiya is intended for the treatment of the following inflammatory diseases:
Slovenian: Zdravilo Hefiya je namenjeno za zdravljenje vnetnih bolezni, opisanih spodaj:
English: All patients received a 2-week standardised dose of prednisone 60 mg / day at study entry followed by a mandatory taper schedule, with complete corticosteroid discontinuation by week 15.
Slovenian: tedenski standardizirani odmerek prednizolona 60 mg/dan, čemur je sledil obvezen program postopnega zmanjševanja, s popolno ukinitvijo kortikosteroidov do 15. tedna.
English: Plaque psoriasis in adults and children
Slovenian: Luskavica (psoriaza) v plakih pri odraslih in otrocih
English: The safety and efficacy of multiple doses of adalimumab were assessed in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopy subscore of 2 to 3) in randomised, double-blind, placebo-controlled studies.
Slovenian: Varnost in učinkovitost večkratnih odmerkov adalimumaba so ocenili pri odraslih z zmernim do hudo aktivnim ulceroznim kolitisom (ocena Mayo od 6 do 12 z endoskopsko podoceno 2 do 3) v randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
English: Figure H: start your injection
Slovenian: Slika H: Sprožite injiciranje
English: The benefit and risk of continued long-term treatment should be periodically evaluated (see adult data in section 5.1)
Slovenian: Tveganja in koristi neprekinjenega dolgotrajnega zdravljenja je treba periodično ovrednotiti (glejte podatke za odrasle bolnike v poglavju 5.1).
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)
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)
English: In study UC-II, 248 patients received 160 mg of adalimumab at week 0, 80 mg at week 2 and 40 mg eow thereafter, and 246 patients received placebo.
Slovenian: V študiji UC-II je 248 bolnikov dobilo 160 mg adalimumaba 0. teden, 80 mg 2. teden in nato 40 mg vsak drugi teden, 246 bolnikov pa je dobivalo placebo.
English: Hypersensitivity, allergies (including seasonal allergy)
Slovenian: Bolezni imunskega sistema* pogosti preobčutljivost, alergije (vključno s sezonsko alergijo)
English: clinical remission clinical response week 52
Slovenian: 52. teden klinična remisija klinični odziv
English: Coagulation and bleeding disorders (including activated partial thromboplastin time prolonged), autoantibody test positive (including double stranded DNA antibody), blood lactate dehydrogenase increased
Slovenian: Preiskave pogosti koagulacija in motnje krvavenja (vključno s podaljšanim aktiviranim parcialnim tromboplastinskim časom), prisotnost avtoprotiteles (vključno s protitelesi proti dvovijačni DNA),
English: In an exploratory clinical trial evaluating the use of another TNF-antagonist, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
Slovenian: V eksploracijskem kliničnem preskušanju infliksimaba, antagonista TNF, pri bolnikih z zmerno do hudo kronično obstruktivno pljučno boleznijo (KOPB), so med prejemniki infliksimaba zabeležili več malignomov, večinoma pljuč ali glave in vratu, kot med primerjalnimi bolniki.
English: Adalimumab has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking adalimumab as monotherapy and those taking concomitant methotrexate.
Slovenian: Adalimumab so raziskali pri bolnikih z revmatoidnim artritisom, poliartikularnim juvenilnim idiopatskim artritisom in psoriatičnim artritisom, ki so adalimumab jemali v monoterapiji, kot pri tistih, ki so jo jemali hkrati z metotreksatom.
English: • low blood measurements for white blood cells, red blood cells and platelet count.
Slovenian: • nizke vrednosti za bele krvne celice, rdeče krvne celice in trombocite.
English: Excipients: adipic acid, citric acid monohydrate, sodium chloride, mannitol, polysorbate 80, hydrochloric acid, sodium hydroxide, water for injections.
Slovenian: Pomožne snovi: adipinska kislina, citronska kislina monohidrat, natrijev klorid, manitol, polisorbat 80, klorovodikova kislina, natrijev hidroksid, voda za injekcije.
English: ACR 20 6 months
Slovenian: ACR 20
English: ACR 50 6 months
Slovenian: ACR 50
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: These infections may be more serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning).
Slovenian: Te okužbe so lahko resne in vključujejo tuberkulozo, okužbe, ki jih povzročijo virusi, glive, paraziti ali bakterije ali drugi nenavadni kužni organizmi,
English: ACR 70 6 months
Slovenian: ACR 70
English: • signs and symptoms of infection such as fever, feeling sick, wounds, dental problems, burning on urination, feeling weak or tired or coughing;
Slovenian: • znake in simptome okužbe, npr. zvišano telesno temperaturo, splošno slabo počutje, rane, težave z zobmi, pekoč občutek med uriniranjem, občutek šibkosti ali utrujenosti ali kašelj,
English: Vaccine
Slovenian: Cepiva
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 zavreči, tudi če ga pozneje vrnete v hladilnik.
English: Ulcerative colitis is an inflammatory disease of the bowel.
Slovenian: Ulcerozni kolitis je vnetna bolezen črevesa.
English: Psoriatic arthritis and axial spondyloarthritis including ankylosing spondylitis There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis.
Slovenian: Psoriatični artritis in aksialni spondiloartritis, vključno z ankiloznim spondilitisom Uporaba adalimumaba pri pediatrični populaciji za indikaciji ankilozni spodilitis in psoriatični artritis ni primerna.
English: Table 11 distribution of patients by age and adalimumab dose received during the OL LI phase age group number of patients at baseline n (%) Minimum, median and maximum dose
Slovenian: Preglednica 11 porazdelitev bolnikov po starosti in odmerku adalimumaba, ki so ga dobivali med odprto uvajalno fazo starostna skupina izhodiščno število bolnikov n (%)
English: HS study I
Slovenian: študija HS I
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
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 delež nemelanomskih rakov je približno 0,2 na 1000 bolnikov-let zdravljenja in limfomov približno 0,3 na 1000 bolnikov-let zdravljenja (glejte poglavje 4.4).
English: • rheumatoid arthritis,
Slovenian: • revmatoidnega artritisa,
English: Statistically and clinically significant improvements from Baseline were also observed in both treatment groups for quality of life parameters (including IMPACT III).
Slovenian: Opazili so tudi statistično in klinično pomembno izboljšanje parametrov kvalitete življenja (vključno z IMPACT III) glede na začetek študije.
English: N (%)
Slovenian: N neuspeh N (%)
English: Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab (see section 4.8).
Slovenian: Merklovih celic pri bolnikih, zdravljenih z TNF-antagonisti, vključno z adalimumabom (glejte poglavje 4.8).
English: • skin infections (including cellulitis and shingles);
Slovenian: • okužbe kože (vključno s celulitisom in pasovcem);
English: Hefiya dose for patients with polyarticular juvenile idiopathic arthritis
Slovenian: Odmerjanje zdravila Hefiya pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom
English: Starting your injection:
Slovenian: Začetek injiciranja:
English: Choosing your injection site:
Slovenian: Izbira mesta injiciranja:
English: Treatment
Slovenian: Zdravljenje
English: Psoriatic arthritis
Slovenian: Psoriatični artritis
English: Surgery or dental procedures
Slovenian: Kirurški poseg ali poseg na zobeh
English: • that Hefiya treatment may increase the potential risks of o infections, including tuberculosis o cancer o nervous system problems o vaccinations
Slovenian: • obvestilo, da lahko zdravljenje z zdravilom Hefiya poveča tveganje o okužb, vključno s tuberkulozo; o raka;
English: Hepatosplenic T-cell lymphoma1) Merkel cell carcinoma (neuroendocrine carcinoma of the skin)1)
Slovenian: karcinom Merklovih celic (nevroendokrini karcinom kože) 1)
English: Place the following items on a clean, flat surface.
Slovenian: Na čisto, ravno površino pripravite naslednje.
English: • do not open the outer box until you are ready to use the syringe.
Slovenian: • ne odpirate zunanje škatle, dokler niste pripravljeni na uporabo injekcijske brizge.
English: Exposure-response relationships between adalimumab concentration and efficacy in paediatric patients with severe chronic plaque psoriasis were established for PASI 75 and PGA clear or minimal, respectively.
Slovenian: Razmerji med izpostavljenostjo in odzivom med koncentracijo adalimumaba in učinkovitostjo pri pediatričnih bolnikih s hudo kronično psoriazo v plakih sta bili za PASI 75 (PASI - Psoriasis Area and Severity Index) in za PGA (PGA - Physician's Global Assessment) čisto ali minimalno.
English: If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately.
Slovenian: Če se simptomi srčnega popuščanja (npr. težko dihanje ali otekanje nog) pojavijo na novo ali se poslabšajo, se morate takoj obrniti na svojega zdravnika.
English: These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitisrelated arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients.
Slovenian: Ta preskušanja so vključile bolnike z revmatoidnim artritisom (tako tiste, ki so imeli bolezen kratek čas, kot tiste, ki so jo imeli že dolgo), juvenilnim idiopatskim artritisom (poliartikularnim juvenilnim idiopatskim artritisom in artritisom, povezanim z entezitisom), aksialnim spondiloartritisom (ankilozirajočim spondilitisom in aksialnim spondiloartritisom brez radiografskega dokaza za AS), psoriatičnim artritisom, Crohnovo boleznijo, ulceroznim kolitisom, psoriazo, hidradenitis suppurativa in uveitisom.
English: This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na 0,8 ml odmerek, kar v bistvu pomeni ‘brez natrija'.
English: • Do not give Hefiya to children with polyarticular juvenile idiopathic arthritis below the age of
Slovenian: • Zdravila Hefiya ne smete dati otroku s poliartikularnim juvenilnim idiopatskim artritisom, če je star manj kot 2 leti.
English: There is no apparent correlation between the presence of anti-adalimumab antibodies and the occurrence of adverse events.
Slovenian: Med prisotnostjo protiteles proti adalimumabu in pojavnostjo neželenih učinkov ni očitne korelacije.
English: • Keep the syringes in the original carton until ready to use to protect from light.
Slovenian: • Injekcijske brizge hranite v originalni ovojnini, dokler niso pripravljene za uporabo, za zagotovitev zaščite pred svetlobo.
English: The Hefiya 40 mg pre-filled syringe should not be used in children or adolescents weighing less than 40 kg with Crohn's disease, since it is not possible to administer doses less than 40 mg.
Slovenian: Zdravila Hefiya 40 mg napolnjena injekcijska brizga ne smete uporabljati pri otrocih ali mladostnikih s Crohnovo boleznijo, ki tehtajo manj kot 40 kg, saj ni mogoče dati odmerka, manjšega od 40 mg.
English: Juvenile idiopathic arthritis
Slovenian: Juvenilni idiopatski artritis
English: Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity, and genotoxicity.
Slovenian: Predklinični podatki na osnovi študij toksičnosti posameznih odmerkov, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: Hefiya dose for paediatric patients with Crohn's disease
Slovenian: Odmerjanje zdravila Hefiya pri pediatričnih bolnikih s Crohnovo boleznijo
English: − The other ingredients are adipic acid, citric acid monohydrate, sodium chloride, mannitol, polysorbate 80, hydrochloric acid, sodium hydroxide and water for injections.
Slovenian: - Druge sestavine zdravila so adipinska kislina, citronska kislina monohidrat, natrijev klorid, manitol, polisorbat 80, klorovodikova kislina, natrijev hidroksid in voda za injekcije.
English: Adalimumab showed statistically significantly greater improvement in the HAQ-S total score and the SF-36 Physical Component Score (PCS) from baseline to week 12 compared to placebo.
Slovenian: Zdravljenje z adalimumabom je pokazalo statistično večje izboljšanje skupnega števila točk v HAQ-S vprašalniku in točk v telesni komponenti (Physical Component Score (PCS)) v SF-36 vprašalniku od začetka do 12. tedna v primerjavi s placebom.
English: By week 68, patients receiving continuous adalimumab treatment showed statistically significant greater improvement of the signs and symptoms of active nr-axSpA as compared to patients allocated to treatment withdrawal during the double-blind period of the study (table 15).
Slovenian: Rezultati do 68. tedna so pokazali statistično značilno izboljšanje znakov in simptomov aktivnega nr-axSpA pri bolnikih, ki so neprekinjeno prejemali adalimumab v primerjavi z bolniki, ki so bili v skupini za prenehanje zdravljenja v dvojno slepem obdobju študije (preglednica 15).
English: Polyarticular juvenile idiopathic arthritis (pJIA)
Slovenian: Poliartikularni juvenilni idiopatski artritis (pJIA)
English: Thus, it is not possible to use Hefiya for children who require less than a full 40 mg dose.
Slovenian: Zato zdravila Hefiya ni mogoče uporabljati pri otroci, ki potrebujejo manj kot polni odmerek 40 mg.
English: You can press a cotton ball or gauze onto the injection site and hold it for 10 seconds.
Slovenian: S koščkom vate ali gaze 10 sekund pritiskajte na mesto injiciranja.
English: • injection site reactions (including pain, swelling, redness or itching);
Slovenian: • reakcije na mestu injiciranja (vključno z bolečino, oteklostjo, pordelostjo ali srbenjem);
English: • sensation disorders such as tingling, prickling or numbness;
Slovenian: • motnje v občutenju kot so ščemenje, zbadanje ali omrtvelost;
English: • psoriatic arthritis,
Slovenian: • psoriatičnega artritisa,
English: The benefit and risk of continued long-term treatment should be periodically evaluated (see section 5.1).
Slovenian: Tveganja in koristi neprekinjenega dolgotrajnega zdravljenja je treba periodično pretehtati (glejte poglavje 5.1).
English: Some cases have had a fatal outcome.
Slovenian: Nekaj primerov se je končalo s smrtjo.
English: • low blood measurements for phosphate;
Slovenian: • nizke krvne vrednosti za fosfat;
English: RA study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, had failed therapy with at least one disease-modifying, anti-rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
Slovenian: V študiji revmatoidnega artritisa I je bilo ocenjeno 271 bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let, pri katerih zdravljenje z vsaj enim imunomodulirajočim antirevmatičnim zdravilom ni bilo uspešno, pri katerih metotreksat v odmerkih od 12,5 do 25 mg (10 mg, če so bili intolerantni za metotreksat) vsak teden ni bil dovolj učinkovit in pri katerih je odmerek metotreksata od 10 do 25 mg ostal stalen vsak teden.
English: 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 Hefiya should be promptly discontinued.
Slovenian: 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.
English: It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis (see section 5.1).
Slovenian: Priporočljivo je, da se tveganja in koristi neprekinjenega dolgotrajnega zdravljenja ovrednotijo enkrat na leto (glejte poglavje 5.1).
English: Table 9 radiographic mean changes over 12 months in RA study III
Slovenian: Preglednica 9: povprečne rentgenografske spremembe v 12 mesecih študije revmatoidnega artritisa III
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: • For a more comfortable injection, take your pen out of the refrigerator 15 to 30 minutes before injecting Hefiya to allow it to reach room temperature.
Slovenian: • Da bo injiciranje prijetnejše, vzemite injekcijski peresnik iz hladilnika približno od 15 do 30 minut pred injiciranjem zdravila , da se ogreje na sobno temperaturo.
English: week 4 clinical remission clinical response (CR
Slovenian: 4. teden klinična remisija klinični odziv
English: A large number (approximately 2100) of prospectively collected pregnancies exposed to adalimumab resulting in live birth with known outcomes, including more than 1500 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
Slovenian: Nosečnost Veliko število (približno 2100) v naprej izbranih nosečnosti, med katerimi so bile matere izpostavljene adalimumabu in jim je sledilo rojstvo živorojenih otrok z znanim izidom, vključno s 1500
English: • Gently pinch the skin at the injection site (see Figure H).
Slovenian: • Nežno stisnite kožo na mestu injiciranja (glejte sliko H).
English: Figure A: Hefiya pre-filled syringe with needle guard and add-on finger flange
Slovenian: Slika A: Napolnjena injekcijska brizga zdravila Hefiya s ščitnikom za iglo in držalom
English: *** p < 0.001 for all comparisons between adalimumab and placebo * p < 0.05 for all comparisons between adalimumab and placebo N/A not applicable
Slovenian: *** p < 0,001 za vse primerjave med adalimumabom in placebom * p < 0,05 za vse primerjave med adalimumabom in placebom np ne pride v poštev
English: MTX n = 257 confidence interval)
Slovenian: MTX n = 257 (95 % interval zaupanja)
English: Table 8 ACR responses in RA study V (percent of patients)
Slovenian: Preglednica 8 odzivi po ACR v študiji revmatoidnega artritisa V (odstotek bolnikov)
English: Of 207 patients, 81 patients continued on adalimumab 40 mg every other week for 10 years.
Slovenian: Od 207 bolnikov jih je 81 nadaljevalo zdravljenje z adalimumabom 40 mg vsak drugi teden še 10 let.
English: Radiographic response
Slovenian: Rentgenografski odziv
English: In the larger AS study I with 315 patients, results showed statistically significant improvement of the signs and symptoms of ankylosing spondylitis in patients treated with adalimumab compared to placebo.
Slovenian: Rezultati obsežnejše študije pri ankilozirajočem spondilitisu I pri 315 bolnikih so pri bolnikih, ki so dobivali adalimumab, pokazali statistično značilno izboljšanje znakov in simptomov ankilozirajočega spondilitisa v primerjavi s placebom.
English: Fever, bruising, bleeding or looking pale
Slovenian: Zvišana telesna temperatura, podplutbe, krvavitve, bledica
English: In RA study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for adalimumab / methotrexate combination therapy versus methotrexate monotherapy and adalimumab monotherapy at week 52, which was maintained through week 104.
Slovenian: V študiji revmatoidnega artritisa V sta se indeks invalidnosti HAQ in telesna komponenta SF 36 ob kombinirani terapiji z adalimumabom in metotreksatom po 52 tednih izboljšala bolj (p < 0,001) kot ob monoterapiji z metotreksatom ali ob monoterapiji z adalimumabom; to se je ohranilo do 104. tedna.
English: * Note: Hefiya is currently only available as 40 mg pre-filled syringe and 40 mg pre-filled pen.
Slovenian: * Opomba: Zdravilo Hefiya je trenutno na voljo samo v 40 mg napolnjeni injekcijski brizgi in 40 mg napolnjenem injekcijskem peresniku.
English: The safety and efficacy of adalimumab were assessed in a multicentre, randomised, double-blind, parallel-group study in 171 children (4-17 years old) with polyarticular JIA.
Slovenian: Varnost in učinkovitost adalimumaba so ocenili v multicentrični randomizirani dvojno slepi študiji vzporednih skupin pri 171 otrocih (starih od 4 do 17 let) s poliartikularnim juvenilnim idiopatskim artritisom.
English: Figure H).
Slovenian: (glejte slika G).
English: • Store your outer carton of syringes in a refrigerator, between 2°C to 8°C.
Slovenian: • Zunanjo škatlo za injekcijske brizge shranjujte v hladilniku, pri temperaturi med 2 °C in 8 °C.
English: The combination of adalimumab and anakinra is not recommended (see section 4.4 “Concurrent administration of biologic DMARDs or TNF-antagonists”).
Slovenian: Kombinacija adalimumaba in anakinre ni priporočljiva (glejte poglavje 4.4 “Sočasna uporaba bioloških DMARD ali antagonistov TNF”).
English: If these medicines do not work well enough, you will be given Hefiya to reduce the signs and symptoms of your disease.
Slovenian: Če ta zdravila ne bodo dovolj dobro delovala, boste dobili zdravilo Hefiya za zmanjšanje znakov in simptomov vaše bolezni.
English: Serious infections including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving adalimumab.
Slovenian: Pri bolnikih, ki so dobivali adalimumab, so bile opisane resne okužbe, vključno s sepso, zaradi bakterijskih, mikobakterijskih, invazivnih glivičnih, parazitskih, virusnih in drugih oportunističnih okužb, npr. listerioza, legioneloza in pnevmocistična okužba.
English: 40 mg adalimumab every week week 26
Slovenian: 40 mg adalimumaba vsak teden
English: Disposing of used syringes:
Slovenian: Odstranjevanje uporabljenih injekcijskih brizg: