FrancophonIA/ELRC3.0 huggingface dataset:
English: Of the 783 patients initially randomised to active treatment in RA-I, 508 completed 52 weeks of placebo-controlled treatment and entered the open-label extension study.
Slovenian: Od 783 bolnikov, ki so bili na začetku randomizirano izbrani za aktivno zdravljenje v študiji RA-I, jih je 508 zaključilo 52-tedensko s placebom nadzorovano zdravljenje in vstopilo v odprt podaljšek študije.Trajno zaviranje napredovanja strukturnih poškodb je bilo opaziti v subpopulaciji 449 bolnikov, ki so se vsaj 2 leti zdravili z zdravilom Cimzia (RA I in odprti podaljšek študije) in so ovrednotili rezultate v obdobju 2 let.
English: Ankylosing spondylitis Non-radiographic axial spondyloarthritits
Slovenian: Neradiografski aksialni spondiloartritis
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled syringe Multipack: 10 (5 x 2) single-use pre-filled syringes and 10 (5 x 2) alcohol wipes
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje v napolnjeni injekcijski brizgi večkratno pakiranje: 10 (5 x 2) napolnjenih injekcijskih brizg za enkratno uporabo in 10 (5 x 2) alkoholnih zložencev
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/008
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/544/008
English: Uncommo vasculitides, lupus erythematosus, drug hypersensitivity (including anaphylactic shock), allergic disorders, auto-antibody positive
Slovenian: Bolezni krvi in limfatičnega sistema redki pancitopenija, splenomegalija, eritrocitoza, morfološke nepravilnosti belih krvnih celi občasni vaskulitis, eritematozni lupus, preobčutljivost za zdravilo (vključno z anafilaktičnim šokom), alergijske reakcije, pozitivna avtoprotitelesa
English: NAME OF THE MEDICINAL PRODUCT Cimzia 200 mg solution for injection in pre-filled syringe
Slovenian: IME ZDRAVILA Cimzia 200 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Patients must be monitored closely for signs and symptoms of infections including tuberculosis before, during and after treatment with Cimzia.
Slovenian: Pred, med in po zdravljenju z zdravilom Cimzia je treba bolnike pozorno spremljati zaradi možnosti pojava okužb, vključno s tuberkulozo.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled syringe Multipack: 6 (3 x 2) single-use pre-filled syringes and 6 (3 x 2) alcohol wipes
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje v napolnjeni injekcijski brizgi večkratno pakiranje: 6 (3 x 2) napolnjenih injekcijskih brizg za enkratno uporabo in 6 (3 x 2) alkoholnih zložencev
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton (for packs of 2 dose-dispenser cartridges and 2 alcohol wipes)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Zunanja škatla (za pakiranje z 2 odmernima vložkoma in 2 alkoholnima zložencema)
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled syringe 2 single-use pre-filled syringes 2 alcohol wipes
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje v napolnjeni injekcijski brizgi 2 napolnjeni injekcijski brizgi za enkratno uporabo 2 alkoholna zloženca
English: Animal studies using a rodent anti-rat TNFα did not reveal evidence of impaired fertility or harm to the foetus.
Slovenian: Študije na živalih, v okviru katerih so uporabljali podganji anti- TNF-α, niso pokazale vpliva na plodnost ali škodljivih vplivov na zarodek, vendar pa podatki ne zadostujejo za oceno vpliva na sposobnost razmnoževanja pri človeku (glejte poglavje 5.3).
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen (AutoClicks) Multipack: 10 (5 x 2) single-use AutoClicks pre-filled pens and 10 (5 x 2) alcohol wipes
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje v napolnjenem injekcijskem peresniku (AutoClicks) večkratno pakiranje: 10 (5 x 2) napolnjenih injekcijskih peresnikov AutoClicks za enkratno uporabo in 10 (5 x 2) alkoholnih zložencev
English: In C-EARLY, Cimzia+ MTX inhibited the radiographic progression compared to placebo+MTX at Week 52 (see Table 6).
Slovenian: V C-EARLY je prišlo v 52. tednu (glejte preglednico 6) pri bolnikih, ki so prejemali zdravilo Cimzia in MTX, do zaviranja radiografske progresije v primerjavi s skupino, ki je prejemala placebo in MTX.
English: Cimzia(b) 400 mg Q4W
Slovenian: Cimzia(b) 400 mg Q4W n = 76
English: • Grasp the clear cap with the other hand and pull it straight off. Do not twist the cap while removing it, this could jam the internal mechanism.
Slovenian: Med odstranjevanjem pokrovčka ne zvijajte, saj lahko tako blokirate notranji mehanizem.
English: •Do not shake the syringe.
Slovenian: • Injekcijske brizge ne stresajte.
English: Reports of pancytopaenia, including aplastic anaemia, have been rare with TNF-antagonists.
Slovenian: Pri zdravilih, ki zavirajo TNF, so redko poročali o pancitopeniji, vključno z aplastično anemijo.
English: Cimzia 200 mg solution for injection in pre-filled syringe certolizumab pegol
Slovenian: Cimzia 200 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku certolizumab pegol
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton Multipack of 6 (3 packs of 2 dose-dispenser cartridges and 2 alcohol wipes) (with bluebox)
Slovenian: Škatla za večkratno pakiranje po 6 (3 pakiranja z 2 odmernima vložkoma in 2 alkoholnima zložencema) (z blue box)
English: ◦ One or two AutoClicks pre-filled pen(s), depending on your prescribed dose ◦ One or two alcohol wipe(s)
Slovenian: ◦ En ali dva napolnjena injekcijska peresnika AutoClicks, odvisno od predpisanega odmerka
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen (AutoClicks) Multipack: 6 (3 x 2) single-use AutoClicks pre-filled pens and 6 (3 x 2) alcohol wipes
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje v napolnjenem injekcijskem peresniku (AutoClicks) večkratno pakiranje: 6 (3 x 2) napolnjenih injekcijskih peresnikov AutoClicks za enkratno uporabo in 6 (3 x 2) alkoholnih zložencev
English: The overall percentage of patients with antibodies to Cimzia detectable on at least one occasion up to Week 24 was 11.7% in the Phase III placebo-controlled trial in patients with psoriatic arthritis.
Slovenian: Pri bolnikih s psoriatičnim artritisom je bil v fazi III s placebom nadzorovanega preskušanja celotni delež bolnikov s protitelesi proti zdravilu Cimzia, ki so bila detektirana vsaj enkrat do 24. tedna,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton Multipack of 10 (5 packs of 2 pre-filled pens and 2 alcohol wipes) (with bluebox)
Slovenian: Škatla za večkratno pakiranje po 10 (5 pakiranj z 2 odmernima vložkoma in 2 alkoholnima zložencema) (z blue box)
English: • swollen lymph nodes
Slovenian: Sandoz GmbH
English: Live vaccines should not be administered concurrently with Cimzia.
Slovenian: Bolniku, ki se sočasno zdravi z zdravilom Cimzia, ne smemo aplicirati živih cepiv.
English: • Look at the expiry date on the syringe and pack.
Slovenian: • Preverite rok uporabnosti na injekcijski brizgi in na pakiranju.
English: Infections and infestations
Slovenian: Operativni in zobozdravstveni posegi
English: Uncommo chills, influenza-like illness, altered temperature perception, night sweats, flushing
Slovenian: Pogostnost Neželeni učinki občasni občutek hladu, gripi podobno obolenje, spremembe v zaznavanju temperature, nočno potenje, vročinski oblivi redki fistula (kjerkoli)
English: NAME OF THE MEDICINAL PRODUCT Cimzia 200 mg solution for injection in pre-filled pen
Slovenian: IME ZDRAVILA Cimzia 200 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: Clinical
Slovenian: Rak
English: - Keep this leaflet.
Slovenian: Ne pokrivajte s pokrovčkom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Multipack of 10 (5 packs of 2 pre-filled syringes and 2 alcohol wipes) (with bluebox)
Slovenian: Škatla za večkratno pakiranje po 10 (5 pakiranj z 2 napolnjenima injekcijskima brizgama in 2 alkoholnima zložencema) (z blue box)
English: No dose recommendations can be made (see section 5.2).
Slovenian: Pri tej populaciji bolnikov zdravila Cimzia niso preučevali, zato priporočil glede odmerjanja ni mogoče dati (glejte poglavje 5.2).
English: EU/1/09/544/009
Slovenian: EU/1/09/544/008 EU/1/09/544/009 EU/1/09/544/010
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 200 mg certolizumab pegol in one ml.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena napolnjena injekcijska brizga vsebuje 200 mg certolizumab pegola v enem ml.
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING Intermediate carton within Multipack of 6 (for 2 pre-filled pens and 2 alcohol wipes) (without blue box)
Slovenian: Vmesna škatla z večkratnim pakiranjem po 6 (2 odmerna vložka in 2 alkoholna zloženca) (brez blue box)
English: Cimzia can be taken together with:
Slovenian: Zdravilo Cimzia lahko jemljete z naslednjimi zdravili:
English: Each pre-filled pen contains 200 mg of certolizumab pegol in one ml.
Slovenian: En odmerni vložek vsebuje 200 mg certolizumab pegola v enem mililitru.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in dose-dispenser cartridge Multipack: 6 (3 x 2) single-use dose-dispenser cartridges and 6 (3 x 2) alcohol wipes
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje v odmernem vložku večkratno pakiranje: 6 (3 x 2) odmernih vložkov za enkratno uporabo in 6 (3 x 2) alkoholnih zložencev
English: Pack size of 2 pre-filled syringes with needle guard and 2 alcohol wipes (for use by healthcare professionals only).
Slovenian: • dve napolnjeni injekcijski brizgi z varovalom za iglo z raztopino, in • dva alkoholna zloženca (za čiščenje izbranega mesta injiciranja).
English: NAME OF THE MEDICINAL PRODUCT Cimzia 200 mg solution for injection in dose-dispenser cartridge
Slovenian: IME ZDRAVILA Cimzia 200 mg raztopina za injiciranje v odmernem vložku
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/006
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/544/006
English: Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection.
Slovenian: Dokler niste povsem prepričani, da razumete, kako je treba odmerek pripraviti in ga injicirati, si zdravila Cimzia ne poskušajte injicirati.
English: Intermediate carton within Multipack of 6 (for 2 dose-dispenser cartridges and 2 alcohol wipes) (without bluebox)
Slovenian: Vmesna škatla z večkratnim pakiranjem po 6 (2 napolnjeni injekcijski brizgi in 2 alkoholna zloženca) (brez blue box)
English: Active dose regimen
Slovenian: Režim odmerjanja učinkovine
English: • Hold the pre-filled pen firmly with one hand around the black handle.
Slovenian: • Z eno roko čvrsto držite črni ročaj napolnjenega injekcijskega peresnika.
English: Do not use this medicine after the expiry date which is stated on the pack and dose-dispenser cartridge after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in injekcijskem peresniku poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: There is limited safety experience with surgical procedures in patients treated with Cimzia.
Slovenian: Pri bolnikih, ki se zdravijo z zdravilom Cimzia, so izkušnje glede varnosti uporabe pri operativnih posegih omejene.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in dose-dispenser cartridge Multipack: 10 (5 x 2) single-use dose-dispenser cartridge and 10 (5 x 2) alcohol wipes
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje v odmernem vložku večkratno pakiranje: 10 (5 x 2) odmernih vložkov za enkratno uporabo in 10 (5 x 2) alkoholnih zložencev
English: Medication body
Slovenian: IME ZDRAVILA
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/007
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/544/007
English: INSTRUCTIONS FOR USE FOR THE CIMZIA INJECTION BY MEANS OF PRE-FILLED PEN
Slovenian: NAVODILA ZA UPORABO NAPOLNJENEGA INJEKCIJSKEGA PERESNIKA ZDRAVILA CIMZIA
English: What Cimzia looks like and contents of the pack Cimzia is provided as a solution for injection in a ready to use pre-filled syringe.
Slovenian: Zdravilo Cimzia je raztopina za injiciranje v napolnjeni injekcijski brizgi za takojšnjo uporabo.
English: Do not use this medicine after the expiry date which is stated on the pack and syringe after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in injekcijski brizgi poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Cimzia 200 mg Q2W a) N=165
Slovenian: Cimzia 200 mg vsak drugi teden a) n = 165
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/544/002
English: Cancer - It is uncommon, but cases of certain types of CANCER have been reported in patients treated with Cimzia or other TNF blockers.
Slovenian: - V redkih primerih so poročali o določenih vrstah RAKA pri bolnikih, ki so uporabljali zdravilo
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING Intermediate carton within Multipack of 10 (for 2 dose-dispenser cartridges and 2 alcohol wipes) (without bluebox)
Slovenian: Vmesna škatla z večkratnim pakiranjem po 10 (2 odmerna vložka in 2 alkoholna zloženca) (brez blue box)
English: • Look at the expiry date on the pack and dose tray.
Slovenian: • Preverite rok uporabnosti na pakiranju in podstavku z zdravilom.
English: Rare fistula (any site)
Slovenian: Splošne težave in spremembe na mestu aplikacije redki fistula (kjerkoli)
English: Cimziaa 200 mg every 2 weeks N=159
Slovenian: Cimzia 200 mg vsak drugi teden n = 95
English: The overall percentage of patients with antibodies to Cimzia detectable on at least one occasion up to Week 24 was 4.4% in the AS001 phase III placebo controlled trial in patients with axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis subpopulations).
Slovenian: Pri bolnikih z aksialnim spondiloartritisom (podskupine z ankilozirajočim spondilitisom in neradiografskim aksialnim spondiloartritisom) je bil v fazi III AS001 s placebom nadzorovanega preskušanja celotni delež bolnikov s protitelesi proti zdravilu Cimzia, ki so bila detektirana vsaj enkrat do 24. tedna, 4,4 %.
English: Medication: dose-dispenser cartridge
Slovenian: Zdravilo: odmerni vložek
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/544/001
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton (for packs of 2 pre-filled syringes and 2 alcohol wipes)
Slovenian: Zunanja škatla (za pakiranje z 2 napolnjenima injekcijskima peresnikoma in 2 alkoholnima zložencema)
English: Cimzia 200 mg solution for injection in dose-dispenser cartridge certolizumab pegol
Slovenian: Cimzia 200 mg raztopina za injiciranje v odmernem vložku certolizumab pegol
English: Rare seizure, cranial nerve inflammation, impaired coordination or balance
Slovenian: Bolezni živčevja občasni periferne nevropatije, omotičnost, tremor
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/005
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/544/005
English: • The starting dose for adults with axial spondyloarthritis is 400 mg given at weeks 0, 2 and 4.
Slovenian: • Začetni odmerek za odrasle z aksialnim spondiloartritisom je 400 mg, ki ga bolniki prejmejo na začetku zdravljenja, po dveh in po štirih tednih.
English: Axial spondyloarthritis Overall Population
Slovenian: Parametri ankilozirajoči spondilitis neradiografski aksialni spondiloartritis aksialni spondiloartritis celotna populacija
English: Not known multiple sclerosis*, Guillain-Barré syndrome*
Slovenian: Pogostnost Neželeni učinki redki krči, vnetje kranialnega živca, motnje koordinacije ali ravnotežja neznana multipla skleroza*, Guillain-Barréjev sindrom*
English: Do not use Cimzia after the expiry date which is stated on the pack and dose tray after EXP.
Slovenian: Po preteku datuma, navedenega na pakiranju in na odmernem vložku poleg oznake EXP, zdravila Cimzia ne uporabljajte.
English: - One or two medication cartridge(s), depending on your prescribed dose - One or two alcohol wipe(s)
Slovenian: • Iz škatlice z zdravilom Cimzia vzemite naslednje pripomočke in jih razporedite po čisti, ravni površini: - eno ali dve napolnjeni injekcijski brizgi, odvisno od predpisanega odmerka - en ali dva alkoholna zloženca
English: Solution for injection in a pre-filled pen (AutoClicks) 2 AutoClicks pre-filled pens 2 alcohol wipes
Slovenian: raztopina za injiciranje v napolnjenem injekcijskem peresniku (AutoClicks) 2 napolnjena injekcijska peresnika
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/004
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/544/004
English: Packs of 2 pre-filled syringes and 2 alcohol wipes, a multipack containing 6 (3 packs of 2) pre-filled syringes and 6 (3 packs of 2) alcohol wipes, and a multipack containing 10 (5 packs of 2) pre-filled syringes and 10 (5 packs of 2) alcohol wipes are available.
Slovenian: Na voljo je pakiranje z 2 injekcijskima brizgama in 2 alkoholnima zložencema, večkratno pakiranje s 6 (3 pakiranja po 2) napolnjenimi injekcijskimi brizgami in 6 (3 pakiranja po 2) alkoholnimi zloženci ter večkratno pakiranje z 10 (5 pakiranj po 2) napolnjenimi injekcijskimi brizgami in 10 (5 pakiranj po 2) alkoholnimi zloženci.
English: Partial remission(c,d)
Slovenian: 12. teden 24. teden Delno izboljšanje(c,d)
English: Solution for injection in dose-dispenser cartridge 2 single-use dose-dispenser cartridges 2 alcohol wipes
Slovenian: raztopina za injiciranje v odmernem vložku 2 odmerna vložka za enkratno uporabo 2 alkoholna zloženca
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING Intermediate carton within Multipack of 10 (for 2 pre-filled syringes and 2 alcohol wipes) (without bluebox)
Slovenian: Vmesna škatla z večkratnim pakiranjem po 10 (2 napolnjeni injekcijski brizgi in 2 alkoholna zloženca) (brez blue box)
English: Pack size of 2 pre-filled pens and 2 alcohol wipes, a multipack containing 6 (3 packs of 2) pre-filled pens and 6 (3 packs of 2) alcohol wipes, a multipack of 10 (5 packs of 2) pre-filled pens and 10 (5 packs of 2) alcohol wipes
Slovenian: Na voljo je pakiranje z 2 odmernima vložkoma in 2 alkoholnima zložencema, večkratno pakiranje s 6 (3 pakiranja po 2) odmernimi vložki in 6 (3 pakiranja po 2) alkoholnimi zloženci ter večkratno pakiranje z 10 (5 pakiranj po 2) odmernimi vložki in 10 (5 pakiranj po 2) alkoholnimi zloženci.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/009
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/544/009
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled pen contains 200 mg certolizumab pegol in one ml.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN En napolnjen injekcijski peresnik vsebuje 200 mg certolizumab pegola v enem ml.
English: Treatment with Cimzia must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Slovenian: Če se pri bolnikih kongestivno srčno popuščanje pojavi na novo ali se njegovi simptomi poslabšajo, moramo zdravljenje z zdravilom Cimzia prekiniti.
English: Packs of 2 dose-dispenser cartridges and 2 alcohol wipes, a multipack containing 6 (3 packs of 2) dose-dispenser cartridges and 6 (3 packs of 2) alcohol wipes, and a multipack containing 10 (5 packs of 2) dose-dispenser cartridges and 10 (5 packs of 2) alcohol wipes are available.
Slovenian: Na voljo je pakiranje z 2 napolnjenima injekcijskima peresnikoma in 2 alkoholnima zložencema, večkratno pakiranje s 6 (3 pakiranja po 2) napolnjenimi injekcijskimi peresniki in 6 (3 pakiranja po 2) alkoholnimi zloženci ter večkratno pakiranje z 10 (5 pakiranj po 2) napolnjenimi injekcijskimi peresniki in 10 (5 pakiranj po 2) alkoholnimi zloženci.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/544/003
English: • increased blood levels of uric acid
Slovenian: • zvišana koncentracija sečne kisline v krvi
English: You should not do both.
Slovenian: Ne smete narediti obojega.
English: These effects can ease your normal daily activities and so improve your quality of life.
Slovenian: Ti učinki lahko olajšajo opravljanje običajnih vsakdanjih dejavnosti in tako izboljšajo kakovost vašega življenja.
English: All studies included long-term extensions for up to 5 years.
Slovenian: Vse študije so obsegale dolgoročno podaljšanje do 5 let.
English: Important to open
Slovenian: Pomembno odpreti
English: • Do not take a double dose to make up for a forgotten tablet.
Slovenian: • Ne vzemite dvojnega odmerka, da bi nadomestili pozabljeno tableto.
English: • The tablets can be taken with or without food.
Slovenian: • Tablete lahko vzamete s hrano ali brez nje.
English: Opportunistic infections (excluding tuberculosis)
Slovenian: Oportunistične okužbe (izključujoč tuberkulozo)
English: • your liver does not work as well as it should
Slovenian: • če vam jetra ne delujejo, kot bi bilo treba.
English: Campoverde di Aprilia (LT) ITALY
Slovenian: Campoverde di Aprilia (LT) Italija in
English: The clinical data are currently limited and long-term studies are ongoing.
Slovenian: Kliničnih podatkov je trenutno malo, dolgoročne študije pa še potekajo.
English: Approximately 97% of drug-related material in milk was parent drug.
Slovenian: Približno 97 % z zdravilom povezanih snovi v mleku je predstavljalo matično zdravilo.
English: • If you miss a dose, take it as soon as you remember.
Slovenian: • Če izpustite odmerek, ga vzemite, čim se spomnite.
English: Table 5: Radiographic changes
Slovenian: Preglednica 5: Radiografske spremembe
English: The most common serious infection was pneumonia.
Slovenian: Najpogostejša resna okužba je bila pljučnica.
English: • you have had tuberculosis or have been in close contact with someone with tuberculosis.
Slovenian: • če ste imeli tuberkulozo, ali če ste bili v tesnem stiku s kom, ki ima tuberkulozo.
English: Clinical Response:
Slovenian: Klinični odziv:
English: Table 4: Response and remission
Slovenian: Preglednica 4: Odziv in remisija
English: • if you have severe liver problems
Slovenian: • če imate resne težave z jetri.
English: Component of a multipack, can't be sold separately.
Slovenian: Del multipakiranja, ni za ločeno prodajo.
English: Interruption of dosing may be needed for management of laboratory abnormalities as described in Table 1.
Slovenian: Prekinitev uporabe je lahko potrebna za obvladanje laboratorijskih nepravilnosti, opisanih v preglednici 1.
English: 148 Pontina, km 52 SNC 04011 Campoverde di Aprilia (Latina) Italy
Slovenian: 148 Pontina, km 52 SNC 04011 Campoverde di Aprilia (Latina) Italija
English: Most of the herpes zoster events involved a single dermatome and were non-serious.
Slovenian: Večina primerov herpesa zostra je zajela en sam dermatom in niso bili resni.
English: • who have been exposed to tuberculosis
Slovenian: • ki so bili izpostavljeni tuberkulozi,
English: There was no change in the LDL/HDL ratio.
Slovenian: Razmerje LDL/HDL se ni spremenilo.
English: • if you have active tuberculosis (TB)
Slovenian: • če imate aktivno tuberkulozo (TB).
English: ACR Response
Slovenian: Odziv ACR
English: Laboratory measures and monitoring guidance Laboratory measure
Slovenian: Laboratorijske meritve in smernice za nadzor Laboratorijske meritve
English: • To help you remember to take RINVOQ, take it at the same time every day.
Slovenian: • Da se boste lažje spomnili vzeti zdravilo RINVOQ, ga vzemite vsak dan ob istem času.
English: • who have resided or travelled in areas of endemic tuberculosis or endemic mycoses; or
Slovenian: • ki so živeli v predelih ali so potovali v predele endemične tuberkuloze ali endemičnih mikoz, ali
English: • if you are pregnant (see section Pregnancy, breast-feeding and contraception)
Slovenian: • če ste noseči (glejte poglavje Nosečnost, dojenje in kontracepcija).
English: Pregnancy RINVOQ must not be used during pregnancy.
Slovenian: Nosečnost Zdravila RINVOQ se ne sme uporabljati med nosečnostjo.
English: The same information is also available on the following URL: www.rinvoq.eu
Slovenian: Iste informacije so na voljo tudi na naslednjem URL: www.rinvoq.eu