FrancophonIA/ELRC3.0 huggingface dataset:
English: In the controlled and uncontrolled portions of the pivotal trials with a median follow-up of up to 3 years, there was a greater incidence of serious infections, including opportunistic infections and TB in patients receiving golimumab 100 mg compared with patients receiving golimumab 50 mg.
Slovenian: V kontroliranih in nekontroliranih delih teh preskušanj z medianim trajanjem spremljanja do 3 let, so opazili večjo incidenco limfoma med bolniki, ki so prejemali golimumab v odmerku 100 mg, kot med bolniki, ki so prejemali golimumab v odmerku 50 mg.
English: Continued therapy should be reconsidered in children who show no evidence of therapeutic benefit within this time period.
Slovenian: Pri otrocih, pri katerih v tem času ni dokazov o terapevtski koristi zdravljenja, je treba premisliti o smiselnosti nadaljevanja zdravljenja.
English: Simponi has minor influence on the ability to ride bicycles, drive and use machines.
Slovenian: Zdravilo Simponi ima majhen vpliv na sposobnost vožnje kolesa, upravljanja vozil in strojev.
English: Among patients remaining in the study and treated with Simponi, improvement in HAQ DI was similar from week 104 through week 256.
Slovenian: Med bolniki, ki so ostali v študiji in so bili zdravljeni z zdravilom Simponi, so podobno izboljšanje rezultata HAQ DI opažali od 104. do 256. tedna.
English: Across the Phase III RA, PsA and AS studies through week 52, antibodies to golimumab were detected by the enzyme immunoassay (EIA) method in 5% (105/2062) of golimumab treated patients and, where tested, nearly all antibodies were neutralising in vitro.
Slovenian: V študijah faze III so pri bolnikih z revmatoidnim artritisom, psoriatičnim artritisom ali ankilozirajočim spondilitisom v času do 52. tedna z encimsko-imunsko metodo (EIA - enzyme immunoassay) ugotovili protitelesa proti golimumabu pri 5 % (105/2062) bolnikov, zdravljenih z golimumabom.
English: • Do not use the pre-filled pen if the expiration date has passed.
Slovenian: • Napolnjenega injekcijskega peresnika ne smete uporabljati, če je pretečen rok uporabnosti zdravila.
English: Part 1 of the study consisted of a 16-week open-label phase in which 173 enrolled children received Simponi 30 mg/m
Slovenian: Prvi del študije je obsegal 16-tedensko odprto fazo, v kateri je 173 vključenih otrok prejemalo 30 mg/m2 (največ 50 mg) zdravila Simponi subkutano vsake 4 tedne v kombinaciji z MTX.
English: Simponi 50 mg treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment at week 24 as measured by change from baseline in total modified vdH-S Score (mean ± SD score was 0.27 ± 1.3 in the placebo group compared with -0.16 ± 1.3 in the Simponi group; p = 0.011).
Slovenian: To so merili na podlagi sprememb v skupni modificirani oceni vdH-S glede na začetne vrednosti (v skupini za prejemanje placeba je srednja vrednost ocene ± SD znašala 0,27 ± 1,3, v primerjavi z -0,16 ± 1,3 v skupini za prejemanje zdravila Simponi; p = 0,011).
English: In nr-Axial SpA, antibodies to golimumab were detected in 7% (14/193) of golimumab treated patients through week 52 by the EIA method.
Slovenian: Pri nr-aksialnem SpA so protitelesa proti golimumabu do 52. tedna z metodo EIA odkrili pri 7 % (14/193) bolnikov, zdravljenih z golimumabom.
English: • Please read the enclosed package leaflet
Slovenian: • Preberite priloženo navodilo za uporabo.
English: One 0.45 mL pre-filled pen contains 45 mg golimumab 1 mL contains 100 mg golimumab.
Slovenian: En napolnjen injekcijski peresnik vsebuje 45 mg golimumaba* v 0,45 ml. 1 ml raztopina vsebuje 100 mg golimumaba.
English: Among patients remaining in the study and treated with Simponi, improvement of the SF-36 physical component was similar from week 104 through week 256.
Slovenian: Med bolniki, ki so ostali v študiji in so bili zdravljeni z zdravilom Simponi, so podobno izboljšanje rezultata vprašalnika SF-36 glede telesnega zdravja opažali od 104. do 256. tedna.
English: Do not attempt to recap the needle.
Slovenian: Na iglo ne smete več namestiti pokrovčka.
English: Simponi 45 mg/0.45 mL solution for injection
Slovenian: Simponi 45 mg/0,45 ml raztopina za injiciranje
English: Bacterial (including sepsis and pneumonia), mycobacterial (including TB), invasive fungal and opportunistic infections, including fatalities, have been reported in patients receiving golimumab.
Slovenian: Pri bolnikih, ki so prejemali golimumab, so poročali o bakterijskih okužbah (vključno s sepso in pljučnico), mikobakterijskih okužbah (vključno s TB), invazivnih glivnih okužbah in oportunističnih okužbah, vključno s smrtnimi primeri.
English: The pen should not be shaken.
Slovenian: Peresnika se ne sme stresati.
English: • Rheumatoid arthritis
Slovenian: • revmatoidnega artritisa,
English: • Sinus infection
Slovenian: • okužba sinusov,
English: Simponi 100 mg injection golimumab SC
Slovenian: Simponi 100 mg injekcija golimumab s.c.
English: PRE-FILLED PEN FOR PAEDIATRIC USE CARTON
Slovenian: ŠKATLA ZA NAPOLNJENI INJEKCIJSKI PERESNIK ZA PEDIATRIČNO UPORABO
English: Do not lift the pre-filled pen away from your skin.
Slovenian: Napolnjenega injekcijskega peresnika še ne smete dvigniti stran od kože.
English: Please contact your doctor or pharmacist.
Slovenian: se posvetujte z zdravnikom ali farmacevtom.
English: • Psoriatic arthritis
Slovenian: • psoriatičnega artritisa,
English: • Seek medical attention immediately if you develop symptoms of an infection, such as fever, tiredness, (persistent) cough, shortness of breath, or flu-like signs, weight loss, night sweats, diarrhoea, wounds, dental problems and a burning feeling when urinating.
Slovenian: • Če se pojavijo simptomi okužbe, na primer zvišana telesna temperatura, utrujenost, (trdovraten) kašelj, kratka sapa ali gripi podobni znaki, izguba telesne mase, nočno potenje, driska, rane, težave z zobmi in pekoč občutek pri uriniranju, nemudoma poiščite zdravniško pomoč.
English: Dose selection notch
Slovenian: Zareza za izbiro odmerka
English: Autoimmune processes
Slovenian: Avtoimunski procesi
English: Do not pull back on the plunger at any time.
Slovenian: Bata ne smete nikoli povleči nazaj.
English: Overview
Slovenian: Pregled
English: INSIDE OF CARTON
Slovenian: NOTRANJA STRAN ŠKATLE
English: Keep the pre-filled pen or pre-filled syringe in the outer carton in order to protect it from light.
Slovenian: Napolnjen injekcijski peresnik ali napolnjeno injekcijsko brizgo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: EU/1/09/546/009 1 pre-filled pen
Slovenian: EU/1/09/546/009 1 napolnjen injekcijski peresnik
English: Position the pre-filled syringe to inject
Slovenian: Postavite napolnjeno injekcijsko brizgo v položaj za injiciranje
English: Do not touch, fan, or blow on the injection site after you have cleaned it.
Slovenian: Ko ste mesto za injiciranje očistili, se ga ne dotikajte, ne pihajte vanj in ga ne sušite s sušilnikom.
English: Among patients remaining in the study and treated with Simponi, similar rates of change from baseline in BASDAI were observed from week 24 through week 256.
Slovenian: Med bolniki, ki so ostali v študiji in so bili zdravljeni z zdravilom Simponi, so podoben delež spremembe odziva BASDAI glede na začetno vrednost opažali od 24. do 256. tedna.
English: If this happens, please contact your doctor or pharmacist.
Slovenian: Če se to zgodi, se posvetujte z zdravnikom ali farmacevtom.
English: Patients with mucosal healing at week 6
Slovenian: Bolniki s celjenjem sluznice v 6. tednu
English: • Taste disturbances
Slovenian: • motnje okušanja,
English: • skin cancer (uncommon).
Slovenian: • kožni rak (občasno).
English: • Do not shake the product
Slovenian: • Zdravila ne stresajte.
English: Lift the pre-filled pen away from the skin.
Slovenian: Napolnjen injekcijski peresnik dvignite s kože.
English: Patients were randomly assigned to placebo or Simponi 50 mg administered subcutaneously every 4 weeks.
Slovenian: Bolnike so randomizirali v placebo skupino in skupino, ki je prejemala zdravilo Simponi 50 mg subkutano vsake 4 tedne.
English: Allow the syringe to sit at room temperature outside the box for 30 minutes before use.
Slovenian: Pred uporabo pustite injekcijsko brizgo 30 minut izven škatle na sobni temperaturi.
English: • Keep the pre-filled syringe in the outer carton in order to protect it from light.
Slovenian: • Napolnjeno injekcijsko brizgo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Simponi 50 mg injection golimumab SC
Slovenian: Simponi 50 mg injekcija golimumab s.c.
English: Simponi 50 mg solution for injection in pre-filled syringe One 0.5 mL pre-filled syringe contains 50 mg of golimumab*.
Slovenian: Simponi 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena 0,5 ml napolnjena injekcijska brizga vsebuje 50 mg golimumaba*.
English: • Lower abdomen
Slovenian: • spodnji del trebuha
English: Simponi contains the active substance called golimumab.
Slovenian: Zdravilo Simponi vsebuje učinkovino golimumab.
English: Simponi 100 mg solution for injection in pre-filled syringe Each 1 mL pre-filled syringe contains 100 mg of golimumab*.
Slovenian: Simponi 100 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena 1 ml napolnjena injekcijska brizga vsebuje 100 mg golimumaba*.
English: Signs and symptoms Key results for the 50 mg dose at weeks 14 and 24 are shown in Table 6 and described below.
Slovenian: Ključni rezultati za 50 mg odmerek v 14. tednu in 24. tednu so prikazani v preglednici 6 in opisani v nadaljevanju.
English: The co-primary endpoints were the percentage of patients achieving ACR 20 response at week 14 and change from baseline in total PsA modified vdH-S score at week 24.
Slovenian: Sočasna primarna končna opazovana dogodka sta bila odstotek bolnikov, ki so dosegli odziv ACR 20 v 14. tednu, in sprememba v skupni oceni vdH-S, prilagojeni za PsA, v 24. tednu glede na začetne vrednosti
English: Simponi 45 mg/0.45 mL solution for injection in pre-filled pen golimumab
Slovenian: Simponi 45 mg/0,45 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku golimumab
English: • In patients weighing less than 80 kg, 50 mg (the 50 mg pre-filled pen or pre-filled syringe must be used to administer this dose) 4 weeks after your last treatment, then every 4 weeks thereafter.
Slovenian: Vzdrževalno zdravljenje • Pri bolnikih, ki tehtajo manj kot 80 kg, 50 mg (za ta odmerek je treba uporabiti 50 mg napolnjen injekcijski peresnik ali napolnjeno injekcijsko brizgo) 4 tedne po zadnjem zdravljenju, nato vsake 4 tedne.
English: Do not touch the plunger during needle cover removal.
Slovenian: Med snemanjem pokrovčka igle se ne smete dotakniti bata.
English: Among patients remaining in the study and treated with Simponi, similar rates of patients showed no progression from baseline from week 104 through week 256.
Slovenian: Med bolniki, ki so ostali v študiji in so bili zdravljeni z zdravilom Simponi, se pri podobnem odstotku bolnikov od 104. do 256. tedna ni pokazalo nobeno poslabšanje bolezni glede na začetno stanje.
English: What Simponi looks like and contents of the pack Simponi is supplied as solution for injection in a single-use pre-filled pen, VarioJect.
Slovenian: Zdravilo Simponi je na voljo v obliki raztopine za injiciranje v napolnjenem injekcijskem peresniku za enkratno uporabo, VarioJect.
English: In the controlled period of RA and PsA pivotal trials, mild ALT elevations (> 1 and < 3 x upper limit of normal (ULN)) occurred in similar proportions of golimumab and control patients in the RA and PsA studies (22.1% to 27.4% of patients); in the AS and nr-Axial SpA studies, more golimumab-treated patients (26.9%) than control patients (10.6%) had mild ALT elevations.
Slovenian: V kontroliranih obdobjih ključnih preskušanj pri bolnikih z RA in PsA se je pojavilo blago zvišanje vrednosti ALT (> 1 in < 3 x zgornje meje normalnih vrednosti (ZMN)), in sicer v podobnih odstotkih pri bolnikih iz skupine, ki je prejemala golimumab, kot pri tistih iz kontrolne skupine (22,1 % do 27,4 % bolnikov).
English: NA: Not Applicable
Slovenian: * p ≤ 0,001 NA (not applicable): ni relevantno
English: Solution for injection in pre-filled syringe 1 pre-filled syringe
Slovenian: raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga
English: Do not lift the pre-filled pen up yet.
Slovenian: Napolnjenega injekcijskega peresnika še ne dvignite.
English: Autoimmune antibodies
Slovenian: Avtoimunska protitelesa
English: Patients were randomised to receive placebo, Simponi 50 mg, or Simponi 100 mg.
Slovenian: Te bolnike so naključno razvrstili bodisi v skupino, ki bo prejemala placebo, zdravilo Simponi 50 mg ali zdravilo Simponi 100 mg.
English: Uncommon: Sepsis including septic shock, pyelonephritis Rare: Tuberculosis, opportunistic infections (such as invasive fungal infections [histoplasmosis, coccidioidomycosis, pneumocytosis], bacterial, atypical mycobacterial infection and protozoal), hepatitis B reactivation, bacterial arthritis, infective bursitis
Slovenian: Preglednica 2 Seznam neželenih učinkov v preglednici Infekcijske in parazitske bolezni Zelo pogosti: okužbe zgornjih dihal (nazofaringitis, faringitis, laringitis in rinitis) Pogosti: bakterijske okužbe (npr. celulitis), okužba spodnjih dihal (npr. pljučnica), virusne okužbe (npr. gripa in herpes), bronhitis, sinusitis, površinske glivične okužbe, absces Občasni: sepsa, vključno s septičnim šokom, pielonefritis Redki: tuberkuloza, oportunistične okužbe (npr. invazivne glivne okužbe [histoplazmoza, kokcidioidomikoza, pnevmocitoza], bakterijske, atipične mikobakterijske okužbe ter okužbe s protozoji), reaktivacija hepatitisa B, bakterijski artritis, infekcijski bursitis
English: Among patients remaining in the study and treated with Simponi, DAS28 and HAQ DI responses were similar from week 104 through week 256.
Slovenian: Med bolniki, ki so ostali v študiji in so bili zdravljeni z zdravilom Simponi, so podobne vrednosti odzivov DAS 28 in rezultatov HAQ DI opažali od 104. do 256. tedna.
English: • Stomach pain
Slovenian: • bolečine v trebuhu,
English: • Rash and itching of the skin
Slovenian: • izpuščaj in srbenje kože,
English: Sorbitol intolerance This medicine contains 41 mg sorbitol (E420) in each pre-filled syringe.
Slovenian: Neprenašanje sorbitola To zdravilo vsebuje 41 mg sorbitola (E420) v eni napolnjeni injekcijski brizgi.
English: Across the Phase III RA, PsA and AS studies through week 52, antibodies to golimumab were detected in 5% (105/2062) of golimumab treated patients and, where tested, nearly all antibodies were neutralising in vitro.
Slovenian: V študijah faze III so pri bolnikih z revmatoidnim artritisom, psoriatičnim artritisom ali ankilozirajočim spondilitisom v času do 52. tedna ugotovili protitelesa proti golimumabu pri 5 % (105/2062) bolnikov, zdravljenih z golimumabom.
English: PRE-FILLED SYRINGE LABEL
Slovenian: NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO
English: • the number of pre-filled syringes and strength is correct o If your dose is 50 mg, you will get one 50 mg pre-filled syringe o If your dose is 100 mg, you will get two 50 mg pre-filled syringes and you will need to give yourself two injections.
Slovenian: • da sta število napolnjenih injekcijskih brizg in jakost pravilna o Če je vaš odmerek 50 mg, boste dobili eno 50 mg napolnjeno injekcijsko brizgo.
English: Simponi 50 mg solution for injection in pre-filled pen One 0.5 mL pre-filled pen contains 50 mg of golimumab*.
Slovenian: Simponi 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku En 0,5 ml napolnjen injekcijski peresnik vsebuje 50 mg golimumaba*.
English: • Kidney infection
Slovenian: • okužba ledvic,
English: Concurrent administration of TNF-antagonists and anakinra Serious infections and neutropenia were seen in clinical studies with concurrent use of anakinra and another TNF-blocking agent, etanercept, with no added clinical benefit.
Slovenian: V kliničnih študijah so pri sočasni uporabi anakinre in drugega zaviralca TNF, t.j.
English: Sorbitol intolerance This medicine contains 20.5 mg sorbitol (E420) in each pre-filled syringe.
Slovenian: Neprenašanje sorbitola To zdravilo vsebuje 20,5 mg sorbitola (E420) v eni napolnjeni injekcijski brizgi.
English: Discontinuation of golimumab therapy should be considered in patients with confirmed significant haematologic abnormalities.
Slovenian: Pri bolnikih s potrjenimi znatnimi hematološkimi motnjami je treba premisliti o ukinitvi zdravljenja z golimumabom.
English: Histidine hydrochloride monohydrate Polysorbate 80
Slovenian: 6.1 Seznam pomožnih snovi sorbitol (E420) histidin histidinijev klorid monohidrat polisorbat 80 voda za injekcije
English: Solution for injection in pre-filled pen (VarioJect) 1 pre-filled pen
Slovenian: raztopina za injiciranje v napolnjenem injekcijskem peresniku (VarioJect) 1 napolnjen injekcijski peresnik
English: Further treatment with golimumab must not be given if a patient develops a serious infection or sepsis (see section 4.3).
Slovenian: Če se pri bolniku pojavi resna okužba ali sepsa, bolnik golimumaba ne sme več prejemati (glejte poglavje 4.3).
English: VAS: Visual Analogue Scale
Slovenian: VAS (Visual Analogue Scale): vizualna analogna skala CHAQ (Child Health Assessment Questionaire): vprašalnik za oceno zdravstvenega stanja otrok
English: Among patients who remained on the Simponi treatment to which they were randomised at study start, improvement in HAQ DI was maintained through week 104.
Slovenian: Med bolniki, na začetku študije naključno razporejenimi v skupino, ki je prejemala zdravilo Simponi, se je pri tistih, ki so se še naprej zdravili z zdravilom Simponi, izboljšanje rezultata na lestvici HAQ DI ohranilo vse do 104. tedna.
English: Signs and symptoms Key results for the 50 mg dose at weeks 14 and 24 are shown in table 4 and described below.
Slovenian: Ključni rezultati za 50 mg odmerek v 14. tednu in 24. tednu so prikazani v Preglednici 4 in opisani v nadaljevanju.
English: Do not press on the orange needle guard before the injection.
Slovenian: Pred injiciranjem ne pritisnite na oranžen ščitnik igle, ker se bo sicer zaklenil in ne boste prejeli odmerka.
English: Simponi is available in packs containing 1 pre-filled syringe and multipacks containing 3 (3 packs of 1) pre-filled syringes.
Slovenian: Zdravilo Simponi je na voljo v pakiranju, ki vsebuje 1 napolnjeno injekcijsko brizgo in 3 (3 pakiranja po 1) napolnjene injekcijske brizge.
English: Check the liquid in the pre-filled pen
Slovenian: Preverite tekočino v napolnjenem injekcijskem peresniku
English: The frequency of anti-dsDNA antibodies at 1 year of follow-up in patients anti-dsDNA negative at baseline was 1.1%.
Slovenian: Po 1 letu spremljanja bolnikov, ki so imeli na začetku študije negativen izvid na dsDNA, je bila pogostnost pojava protiteles proti dsDNA
English: EU/1/09/546/007 1 pre-filled syringe EU/1/09/546/008 3 pre-filled syringes
Slovenian: EU/1/09/546/007 1 napolnjena injekcijska brizga EU/1/09/546/008 3 napolnjene injekcijske brizge
English: Do not use the pre-filled pen if it is dropped without the cap on.
Slovenian: Napolnjenega injekcijskega peresnika ne uporabite, če vam pade, ko je že brez pokrovčka.
English: Orange Priming Band
Slovenian: Oranžen pas
English: 0.45 mL solution in a pre-filled syringe (Type 1 glass) with a fixed needle (stainless steel) and a needle cover (rubber containing latex) in a pre-filled pen.
Slovenian: 0,45 ml raztopine v napolnjeni injekcijski brizgi (iz stekla tipa 1) s pritrjeno iglo (iz nerjavečega jekla) in ščitnikom igle (iz gume, ki vsebuje lateks) v napolnjenem injekcijskem peresniku.
English: Among patients remaining in the study and treated with Simponi, DAS28 responses were similar from week 104 through week 256.
Slovenian: Med bolniki, ki so ostali v študiji in so bili zdravljeni z zdravilom Simponi, so podobne vrednosti odzivov DAS 28 opažali od 104. do 256. tedna.
English: Simponi 45 mg/0.45 mL solution for injection in pre-filled pen.
Slovenian: Simponi 45 mg/0,45 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: Autoimmune disease
Slovenian: Očesne bolezni
English: Rare: Bladder disorders, renal disorders Reproductive system and breast disorders
Slovenian: Redki: bolezni sečnega mehurja, bolezni ledvic
English: • Gall stones
Slovenian: • žolčni kamni,
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Simponi.
Slovenian: Pred začetkom uporabe zdravila Simponi se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: 1st administration: _______________________
Slovenian: 1. uporaba: _______________________
English: Keep the pre-filled syringe in the outer carton in order to protect from light
Slovenian: Napolnjeno brizgo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Sorbitol intolerance This medicine contains 41 mg sorbitol (E420) in each pre-filled pen.
Slovenian: Neprenašanje sorbitola To zdravilo vsebuje 41 mg sorbitola (E420) v enem napolnjenem injekcijskem peresniku.
English: • Do not use the pre-filled pen if it is dropped without the cap in place.
Slovenian: • Napolnjenega injekcijskega peresnika ne smete uporabiti, če vam je padel brez pokrovčka.
English: 50 mg) + MTX or placebo + MTX every 4 weeks.
Slovenian: Simponi 50 mg + MTX
English: For the 50 mg dose, see section 3 “How to use Simponi” of the Simponi 50 mg pre-filled pen or pre-filled syringe package leaflet.
Slovenian: Za otroke, ki tehtajo vsaj 40 kg, sta na voljo napolnjeni injekcijski peresnik ali napolnjena injekcijska brizga s fiksnim odmerkom 50 mg. Za odmerek 50 mg glejte poglavje 3 "Kako uporabljati zdravilo Simponi" v navodilu za uporabo za zdravilo Simponi 50 mg napolnjeni injekcijski peresnik ali napolnjena injekcijska brizga.
English: • Place your pen in a sharps container straight away.
Slovenian: • Peresnik takoj odvrzite v posodo za odlaganje ostrih odpadkov.
English: • Do not put the cap back on because it may damage the needle inside the pre-filled pen.
Slovenian: • Pokrovčka ne smete več postaviti na napolnjeni injekcijski peresnik, ker bi tako lahko poškodovali iglo v njem.
English: • Place your pre-filled syringe in a sharps container straight away.
Slovenian: • Napolnjeno injekcijsko brizgo takoj odvrzite v posodo za odlaganje ostrih odpadkov.
English: What Simponi looks like and contents of the pack Simponi is supplied as solution for injection in a single-use pre-filled pen.
Slovenian: Zdravilo Simponi je na voljo kot raztopina za injiciranje v obliki napolnjenih injekcijskih brizg za enkratno uporabo.
English: Simponi is supplied in a single use pre-filled pen called VarioJect.
Slovenian: Zdravilo Simponi je na voljo v obliki napolnjenega injekcijskega peresnika VarioJect za enkratno uporabo.
English: Simponi 100 mg solution for injection in pre-filled syringe golimumab
Slovenian: Simponi 100 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku golimumab
English: Ask your doctor if you don't know if these fungal infections are common in the area in which you have lived or travelled.
Slovenian: Če ne veste, ali so te glivne okužbe pogoste na območju, kjer ste bivali ali kamor ste potovali, se posvetujte z zdravnikom.
English: • Tell your surgeon or dentist performing the procedure that you are having treatment with
Slovenian: • Kirurgu ali zobozdravniku, ki bo opravil poseg, povejte, da se zdravite z zdravilom Simponi, in mu pokažite svojo opozorilno kartico za bolnika.
English: There have been reports of pancytopenia, leukopenia, neutropenia, agranulocytosis, aplastic anaemia, and thrombocytopenia in patients receiving TNF-blockers, including golimumab.
Slovenian: Pri bolnikih, ki so prejemali zaviralce TNF, vključno z golimumabom, so poročali o pojavu pancitopenije, levkopenije, nevtropenije, agranulocitoze, aplastične anemije in trombocitopenije.
English: Symptoms include persistent rash, fever, joint pain and tiredness.
Slovenian: Simptomi vključujejo trdovraten izpuščaj, zvišano telesno temperaturo, bolečine v sklepih in utrujenost.
English: Simponi has minor influence on your ability to ride bicycles, drive and use tools or machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Simponi ima majhen vpliv na sposobnost vožnje kolesa, upravljanja vozil in orodij ali strojev.