FrancophonIA/ELRC3.0 huggingface dataset:
English: NA ORAL Standard: MTX inadequate responders
Slovenian: NA ORAL Standard: bolniki z nezadostnim odzivom na MTX
English: Lymphoma and other cancers (such as lung, breast, melanoma, prostate and pancreatic) have been reported in patients treated with XELJANZ.
Slovenian: Pri bolnikih, ki so prejemali zdravilo XELJANZ, so poročali o limfomu in drugih vrstah raka (kot so pljučni rak, rak dojk, melanom, rak prostate in rak trebušne slinavke).
English: Tofacitinib 10 mg twice daily + MTX N=309
Slovenian: tofacitinib 10 mg dvakrat na dan + MTX n = 309
English: Each tablet contains 5 mg of tofacitinib (as tofacitinib citrate).
Slovenian: Ena tableta vsebuje 5 mg tofacitiniba (v obliki tofacitinibijevega citrata).
English: In the controlled portion of the RA phase 3 monotherapy study (0-3 months) (study I, see section 5.1), ALT elevations greater than 3x ULN were observed in 1.65%, 0.41%, and 0% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively.
Slovenian: V nadzorovanem delu preskušanja 3. faze z monoterapijo pri bolnikih z RA (0-3 meseci) (Preskušanje I, glejte poglavje 5.1) so zvečanja vrednosti ALT, večja od 3-kratne vrednosti ZMN, opazili pri 1,65 % bolnikov, ki so prejemali placebo, 0,41 % bolnikov, ki so prejemali 5 mg tofacitiniba dvakrat na dan, in 0 % bolnikov, ki so prejemali 10 mg tofacitiniba dvakrat na dan.
English: Tofacitinib 10 mg twice daily + MTX
Slovenian: tofacitinib 10 mg dvakrat na dan + MTX
English: Tofacitinib 5 mg twice daily Tofacitinib 10 mg twice daily placebo
Slovenian: tofacitinib 10 mg dvakrat na dan placebo tofacitinib 10 mg dvakrat na dan placebo tofacitinib 5 mg dvakrat na dan tofacitinib 10 mg dvakrat na dan placebo
English: Inadequate response to a least 1 TNFi due to lack of efficacy and/or intolerability.
Slovenian: Nezadosten odziv na najmanj 1 antagonist TNF zaradi nezadostne učinkovitosti in/ali intolerance.
English: Tofacitinib 10 mg twice daily + MTX N=290 Mean (SD)a
Slovenian: tofacitinib 10 mg dvakrat na dan + MTX n = 290 povprečje (SD)
English: Tofacitinib 5 mg twice daily monotherapy N=241
Slovenian: Monoterapija s tofacitinibom 5 mg dvakrat na dan n = 241
English: Prior TNFi failure Prior corticosteroid failure
Slovenian: Predhodno neučinkovito zdravljenje s TNFi Predhodno neučinkovito zdravljenje s kortikosteroidi Predhodno neučinkovito zdravljenje z imunosupresivi Uporaba kortikosteroidov ob izhodišču
English: Dose should be reduced to 5 mg twice daily when the indicated dose in the presence of normal hepatic function is 10 mg twice daily (see section 5.2).
Slovenian: Če je indicirani odmerek v primeru normalnega delovanja jeter 10 mg dvakrat na dan, je treba odmerek zmanjšati na 5 mg dvakrat na dan (glejte poglavje 5.2).
English: Tofacitinib 5 mg twice daily + MTX Mean difference from placebob (CI)
Slovenian: tofacitinib 5 mg dvakrat na dan + MTX povprečna razlika glede na placebo (IZ)
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih nateg ligamenta, nateg mišic
English: Patients receiving tofacitinib 5 mg or 10 mg twice daily demonstrated significantly greater improvement from baseline in fatigue compared to placebo in all 5 studies.
Slovenian: V vseh 5 preskušanjih je bilo pri bolnikih, ki so prejemali 5 mg ali 10 mg tofacitiniba dvakrat na dan, izboljšanje utrujenosti glede na izhodišče pomembno večje v primerjavi s placebom.
English: BID=twice daily.
Slovenian: 5 mg dvakrat na dan.
English: Dose should be reduced to 5 mg film-coated tablet once daily when the indicated dose in the presence of normal renal function is 11 mg prolonged-release tablet once daily (see section 5.2).
Slovenian: Če je indicirani odmerek v primeru normalnega delovanja ledvic 11 mg tableta s podaljšanim sproščanjem enkrat na dan, je treba odmerek zmanjšati na 5 mg filmsko obloženo tableto enkrat na dan (glejte poglavje 5.2).
English: Treatment group
Slovenian: Prekinitev zdravljenja
English: Each tablet contains 10 mg of tofacitinib (as tofacitinib citrate).
Slovenian: Ena tableta vsebuje 10 mg tofacitiniba (v obliki tofacitinibijevega citrata).
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema anemija levkopenija, limfopenija, nevtropenija
English: Tofacitinib 10 mg twice daily + MTX N=134
Slovenian: tofacitinib 10 mg dvakrat na dan + MTX n = 134
English: Tofacitinib 5 mg twice daily + MTX N=316
Slovenian: tofacitinib 5 mg dvakrat na dan + MTX n = 316
English: Leukopenia Lymphopenia Neutropenia
Slovenian: Psihiatrične motnje nespečnost
English: Patients should be closely monitored for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy.
Slovenian: To velja tudi za bolnike, pri katerih je bil test na latentno okužbo s TB pred začetkom zdravljenja negativen.
English: ORAL Solo and ORAL Sync.
Slovenian: Preskušanja Preskušanje I (ORAL Solo)
English: ORAL Standard: MTX inadequate responders
Slovenian: ORAL Standard: bolniki z nezadostnim odzivom na MTX
English: Tofacitinib 5 mg twice daily + MTX N=133
Slovenian: tofacitinib 5 mg dvakrat na dan + MTX n = 133
English: - The prolonged-release tablets are also available in bottles with silica gel desiccant containing
Slovenian: - Tablete s podaljšanim sproščanjem so na voljo tudi v plastenkah s silikagelom kot sušilnim sredstvom, ki vsebujejo 30 ali 90 tablet s podaljšanim sproščanjem.
English: EU/1/17/1178/001 60 film-coated tablets EU/1/17/1178/002 180 film-coated tablets
Slovenian: EU/1/17/1178/001 60 filmsko obloženih tablet EU/1/17/1178/002 180 filmsko obloženih tablet
English: The virus may become active while you are taking XELJANZ.
Slovenian: Med jemanjem zdravila XELJANZ lahko virus znova postane aktiven.
English: Table 14: Phase 3 clinical studies of tofacitinib 5 mg and 10 mg twice daily doses in patients with UC
Slovenian: Preglednica 14: Klinična preskušanja 3. faze uporabe tofacitiniba v odmerkih 5 mg in 10 mg dvakrat na dan pri bolnikih z UK OCTAVE Induction 1 OCTAVE Induction 2 OCTAVE Sustain
English: Tofacitinib total daily dose should be reduced by half in patients receiving potent inhibitors of cytochrome P450 (CYP) 3A4 (e.g., ketoconazole) and in patients receiving 1 or more concomitant medicinal products that result in both moderate inhibition of CYP3A4 as well as potent inhibition of CYP2C19 (e.g., fluconazole) (see section 4.5).
Slovenian: Pri bolnikih, ki prejemajo močne zaviralce citokroma P450 (CYP) 3A4 (npr. ketokonazol), in pri bolnikih, ki sočasno prejemajo 1 ali več zdravil, ki zmerno zavirajo CYP3A4 in hkrati močno zavirajo CYP2C19 (npr. flukonazol) (glejte poglavje 4.5), je treba skupni dnevni odmerek tofacitiniba zmanjšati za polovico.
English: XELJANZ 10 mg film-coated tablets
Slovenian: XELJANZ 10 mg filmsko obložene tablete
English: Tofacitinib dose should be reduced a
Slovenian: Zmanjšajte odmerek tofacitiniba
English: Your doctor will test you for tuberculosis before starting XELJANZ and may retest during treatment - if you have any chronic lung disease - if you have liver problems
Slovenian: Pred začetkom zdravljenja z zdravilom XELJANZ in morda tudi med zdravljenjem vas bo zdravnik testiral za tuberkulozo.
English: Tofacitinib 5 mg twice daily + DMARD(s) N=312
Slovenian: tofacitinib 5 mg dvakrat na dan + DMARD**** n = 312
English: In the RA long-term extension studies, on background DMARDs, ALT elevations greater than 3x ULN were observed in 1.8% and 1.6% of patients receiving tofacitinib 5 mg and 10 mg twice daily, respectively.
Slovenian: V dolgoročnih podaljšanih preskušanjih z osnovnim zdravljenjem z DMARD pri bolnikih z RA so zvečanja vrednosti ALT, večja od 3-kratne vrednosti ZMN, opazili pri 1,8 % bolnikov, ki so prejemali 5 mg tofacitiniba dvakrat na dan, in 1,6 % bolnikov, ki so prejemali 10 mg tofacitiniba dvakrat na dan. Zvečanja vrednosti AST, večja od 3-kratne vrednosti ZMN, so v obeh skupinah (5 mg in 10 mg tofacitiniba dvakrat na dan) opazili pri < 1,0 % bolnikov.
English: • Malignancy
Slovenian: • maligno obolenje,
English: XELJANZ 5 mg film-coated tablets
Slovenian: XELJANZ 5 mg filmsko obložene tablete
English: Methotrexate
Slovenian: Limfociti
English: Patients receiving either 5 mg or 10 mg tofacitinib twice daily experienced significantly greater improvement from baseline compared to placebo in all 8 domains as well as the Physical Component Summary and Mental Component Summary scores at month 3 in ORAL Solo, ORAL Scan and ORAL Step.
Slovenian: V preskušanjih ORAL Solo, ORAL Scan in ORAL Step je bilo izboljšanje glede na izhodišče v 3. mesecu v primerjavi s placebom pomembno večje pri bolnikih, ki so prejemali 5 mg ali 10 mg tofacitiniba dvakrat na dan, v vseh 8 domenah, kot tudi pri rezultatih povzetka telesne komponente (Physical Component Summary) in povzetka duševne komponente (Mental Component Summary).
English: Adalimumab 40 mg QOW + MTX
Slovenian: adalimumab 40 mg vsak drugi teden + MTX
English: Hypertension
Slovenian: Nevtrofilci
English: Tofacitinib 5 mg twice daily monotherapy N=370
Slovenian: Monoterapija s tofacitinibom 5 mg dvakrat na dan n = 370
English: 0.3% of patients and for ALC between 500 and 750 cells/mm3 in 1.9% of patients for the 5 mg twice daily and 10 mg twice daily doses combined.
Slovenian: 3 pa pri skupno 1,9 % bolnikov v skupinah, ki sta prejemali odmerke 5 mg dvakrat na dan in 10 mg dvakrat na dan.
English: Drug-drug interactions
Slovenian: Medsebojno delovanje z zdravili
English: DAS284(ESR)<2.6 Month 3:
Slovenian: 6. mesec: ACR20 DAS284(ESR) < 2,6 3. mesec: HAQ-DI
English: Tofacitinib 5 or 10 mg twice daily-treated patients demonstrated significantly greater improvement in physical functioning compared to placebo as early as week 2 in
Slovenian: V preskušanjih ORAL Solo in ORAL Sync so pri bolnikih, ki so prejemali 5 mg ali 10 mg tofacitiniba dvakrat na dan, opazili pomembno izboljšanje telesne funkcije v primerjavi s placebom že po 2 tednih.
English: Bacteraemia Staphylococcal bacteraemia Pneumocystis jirovecii pneumonia Pneumonia pneumococcal Pneumonia bacterial
Slovenian: Pneumocystis jirovecii, pnevmokokna pljučnica, bakterijska pljučnica, encefalitis, atipična mikobakterijska okužba, okužba s citomegalovirusom, bakterijski artritis tuberkuloza osrednjega živčevja, kriptokokni meningitis, okužba s kompleksom Mycobacterium avium
English: In the clinical studies in UC, changes in ANC observed with tofacitinib treatment were similar to the changes observed in clinical studies in RA.
Slovenian: V kliničnih preskušanjih pri bolnikih z UK so bile spremembe ANC, ki so jih opazili pri zdravljenju s tofacitinibom, podobne spremembam, ki so jih opazili v kliničnih preskušanjih pri bolnikih z RA.
English: ORAL Step: TNF inhibitor inadequate responders N=118
Slovenian: ORAL Step: bolniki z nezadostnim odzivom na antagoniste TNF
English: Your doctor will decide whether you need to have herpes zoster vaccination - if you have heart problems, high blood pressure, or high cholesterol - if you have narrowing of the digestive tract tell your doctor as there have been rare reports of blockage in the digestive tract in patients taking other medicines using similar prolonged-release tablets - when you take XELJANZ 11 mg prolonged-release tablets, you may see something in your stool that looks like a tablet.
Slovenian: - če imate zoženje prebavne cevi, obvestite zdravnika, saj so v redkih primerih pri bolnikih, ki so jemali druga zdravila v podobni obliki tablet s podaljšanim sproščanjem, poročali o zapori prebavne cevi.
English: Package leaflet: Information for the patient XELJANZ 11 mg prolonged-release tablets tofacitinib
Slovenian: Navodilo za uporabo XELJANZ 11 mg tablete s podaljšanim sproščanjem tofacitinib
English: XELJANZ 10 mg film-coated tablets tofacitinib
Slovenian: XELJANZ 10 mg filmsko obložene tablete tofacitinib
English: Tofacitinib 10 mg twice daily monotherapy N=243
Slovenian: Monoterapija s tofacitinibom 10 mg dvakrat na dan n = 243
English: With prior TNF inhibitor failure
Slovenian: brez predhodnega neučinkovitega zdravljenja z zaviralcem TNF
English: In the RA long-term safety population, confirmed decreases in ALC below 500 cells/mm3 occurred in 1.3% of patients and for ALC between 500 and 750 cells/mm in 8.4% of patients for the 5 mg twice daily and 10 mg twice daily doses combined.
Slovenian: V populaciji z RA, pri kateri so preučevali dolgoročno varnost, so zmanjšanje ALC pod 500 celic/mm potrdili pri skupno 1,3 % bolnikov, zmanjšanje ALC med 500 in 750 celic/mm
English: Tofacitinib dose should be reduced to 5 mg film-coated tablet once daily in patients receiving 11 mg prolonged-release tablet once daily.
Slovenian: Pri bolnikih, ki prejemajo tofacitinib 11 mg tableto s podaljšanim sproščanjem enkrat na dan, je treba odmerek zmanjšati na 5 mg filmsko obloženo tableto enkrat na dan.
English: Tofacitinib 5 mg twice daily Mean difference from MTXd (CI)
Slovenian: tofacitinib 5 mg dvakrat na dan povprečna razlika glede na MTX (IZ)
English: XELJANZ 5 mg film-coated tablets tofacitinib
Slovenian: XELJANZ 5 mg filmsko obložene tablete tofacitinib
English: ≤3 weekly doses (MTX-naïve).
Slovenian: ≤ 3-tedenski odmerki (bolniki, ki še niso prejemali MTX).
English: Tofacitinib 10 mg twice daily + MTX Mean difference from placebob
Slovenian: tofacitinib 10 mg dvakrat na dan + MTX povprečna razlika glede na placebo (IZ)
English: • Tofacitinib dose should be reduced to 5 mg once daily in patients receiving 5 mg twice daily.
Slovenian: • pri bolnikih, ki prejemajo 5 mg tofacitiniba dvakrat na dan, je treba odmerek zmanjšati na 5 mg enkrat na dan,
English: In the clinical studies in UC, changes in liver enzyme tests observed with tofacitinib treatment were similar to the changes observed in clinical studies in RA.
Slovenian: V kliničnih preskušanjih pri bolnikih z UK so bile spremembe v rezultatih testov jetrnih encimov, ki so jih opazili pri zdravljenju s tofacitinibom, podobne spremembam, ki so jih opazili v kliničnih preskušanjih pri bolnikih z RA.
English: Tofacitinib 10 mg twice daily monotherapy N=394
Slovenian: Monoterapija s tofacitinibom 10 mg dvakrat na dan n = 394
English: Tofacitinib 10 mg twice daily Mean difference from MTXd (CI)
Slovenian: tofacitinib 10 mg dvakrat na dan povprečna razlika glede na MTX (IZ)
English: • skin blisters
Slovenian: • mehurje na koži,
English: Without prior TNF inhibitor failureb
Slovenian: rentgen antagonist TNF-IR
English: Patients randomised to placebo were advanced in a blinded manner at month 3 to either tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily and received treatment until month 6.
Slovenian: Bolniki, ki so jih randomizirali v skupino s tofacitinibom, so 6 mesecev prejemali 5 mg tofacitiniba dvakrat na dan ali 10 mg dvakrat na dan. Bolnike, ki so jih randomizirali v skupino s placebom, so po 3. mesecih slepo prerazporedili tako, da so prejemali bodisi 5 mg tofacitiniba dvakrat na dan bodisi 10 mg tofacitiniba dvakrat na dan do 6. meseca.
English: In the RA long-term extension studies, on monotherapy, ALT elevations greater than 3x ULN were observed in 1.1% and 1.4% of patients receiving tofacitinib 5 mg and 10 mg twice daily, respectively.
Slovenian: V dolgoročnih podaljšanih preskušanjih z monoterapijo pri bolnikih z RA so zvečanja vrednosti ALT, večja od 3-kratne vrednosti ZMN, opazili pri 1,1 % bolnikov, ki so prejemali 5 mg tofacitiniba dvakrat na dan, in 1,4 % bolnikov, ki so prejemali 10 mg tofacitiniba dvakrat na dan. Zvečanja vrednosti AST, večja od 3-kratne vrednosti ZMN, so v obeh skupinah (5 mg in 10 mg tofacitiniba dvakrat na dan) opazili pri < 1,0 % bolnikov.
English: In the clinical studies in UC, changes in ALC observed with tofacitinib treatment were similar to the changes observed in clinical studies in RA.
Slovenian: V kliničnih preskušanjih pri bolnikih z UK so bile spremembe ALC, ki so jih opazili pri zdravljenju s tofacitinibom, podobne spremembam, ki so jih opazili v kliničnih preskušanjih pri bolnikih z RA.
English: In the controlled RA clinical studies, confirmed decreases in ALC below 500 cells/mm3 occurred in 0.3% of patients and for ALC between 500 and 750 cells/mm3 in 1.9% of patients for the 5 mg twice daily and 10 mg twice daily doses combined.
Slovenian: V nadzorovanih kliničnih preskušanjih pri bolnikih z RA so zmanjšanje ALC pod 500 celic/mm potrdili pri skupno 0,3 % bolnikov, zmanjšanje ALC med 500 in 750 celic/mm
English: • Inherited coagulation disorder
Slovenian: • dedna motnja strjevanja krvi,
English: Patients randomised to placebo were advanced in a blinded manner at month 3 to either tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily and received treatment until month 12.
Slovenian: Bolniki, ki so jih randomizirali v skupino s tofacitinibom, so 12 mesecev prejemali 5 mg tofacitiniba dvakrat na dan ali 10 mg dvakrat na dan. Bolnike, ki so jih randomizirali v skupino s placebom, so po 3. mesecih slepo prerazporedili tako, da so prejemali bodisi 5 mg tofacitiniba dvakrat na dan bodisi 10 mg tofacitiniba dvakrat na dan do 12. meseca.
English: Tofacitinib exposure is decreased when coadministered with potent CYP inducers (e.g., rifampicin).
Slovenian: Pri sočasni uporabi močnih induktorjev CYP (npr. rifampicina) se izpostavljenost tofacitinibu zmanjša.
English: Adalimumab 40 mg SC q2W
Slovenian: Skupina zdravljenja placebo tofacitinib 5 mg dvakrat na dan adalimumab 40 mg SC q2W
English: (CI)
Slovenian: e,*
English: TNFi inadequate responders b
Slovenian: bolniki z nezadostnim odzivom na antagonist TNF
English: Coadministered Drug
Slovenian: Sočasno uporabljeno zdravilo
English: Lymphocytes In the controlled RA clinical studies, confirmed decreases in ALC below 500 cells/mm occurred in
Slovenian: Pri bolnikih s potrjenim številom limfocitov, manjšim od 750 celic/mm
English: In the clinical studies in UC, changes in lipids observed with tofacitinib treatment were similar to the changes observed in clinical studies in RA.
Slovenian: V kliničnih preskušanjih pri bolnikih z UK so bile spremembe vrednosti lipidov, ki so jih opazili pri zdravljenju s tofacitinibom, podobne spremembam, ki so jih opazili v kliničnih preskušanjih pri bolnikih z RA.
English: Dose should be reduced to 5 mg once daily when the indicated dose in the presence of normal renal function is 5 mg twice daily.
Slovenian: Če je indicirani odmerek v primeru normalnega delovanja ledvic 5 mg dvakrat na dan, je treba odmerek zmanjšati na 5 mg enkrat na dan.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj dispneja, kongestija sinusov
English: Tofacitinib twice daily + MTX
Slovenian: Čas placebo tofacitinib dvakrat na dan + MTX
English: Patients randomised to tofacitinib received 5 mg twice daily or tofacitinib 10 mg twice daily for 12 months.
Slovenian: 12-tedenskega prejemanja 5 mg tofacitiniba dvakrat na dan ali placeba.
English: (as measured on a 0-100 visual analogue scale) from baseline at week 2 (first post-baseline assessment) through month 3 compared to placebo in studies OPAL BROADEN and OPAL BEYOND (nominal p≤ 0.05).
Slovenian: V preskušanjih OPAL BROADEN in OPAL BEYOND so pri bolnikih, ki so prejemali 5 mg tofacitiniba dvakrat na dan, od 2. tedna (prvega ocenjevanja po izhodiščnem) do 3. meseca opažali večje izboljšanje artritične bolečine (izmerjene po vizualni analogni lestvici 0-100) od izhodišča v primerjavi s placebom (nominalna vrednost p ≤ 0,05).
English: Patients receiving tofacitinib 5 mg or 10 mg twice daily demonstrated significantly greater improvement from baseline in both scales compared to placebo in ORAL Sync, ORAL Standard and ORAL Scan.
Slovenian: V preskušanjih ORAL Sync, ORAL Standard in ORAL Scan je bilo pri bolnikih, ki so prejemali 5 mg ali 10 mg tofacitiniba dvakrat na dan, izboljšanje na obeh lestvicah glede na izhodišče pomembno večje v primerjavi s placebom.
English: Table 11: LS Mean change from baseline in HAQ-DI at month 3 Placebo + MTX
Slovenian: Preglednica 10: Radiografske spremembe v 6. in 12. mesecu ORAL Scan: bolniki z nezadostnim odzivom na MTX placebo + MTX
English: Tuberculosis of central nervous system
Slovenian: Bolezni živčevja glavobol parestezija
English: PHARMACOLOGICAL PROPERTIES
Slovenian: Farmakokinetika
English: Dose should be reduced to 5 mg twice daily when the indicated dose in the presence of normal renal function is 10 mg twice daily.
Slovenian: Če je indicirani odmerek v primeru normalnega delovanja ledvic 10 mg dvakrat na dan, je treba odmerek zmanjšati na 5 mg dvakrat na dan.
English: Pyrexia Oedema peripheral Fatigue
Slovenian: Splošne težave in spremembe na mestu aplikacije pireksija, periferni edem, utrujenost
English: Active substance: Ceftiofur
Slovenian: Zdravilna učinkovina: Ceftiofur
English: Milk: zero days.
Slovenian: Mleko: nič dni
English: Cattle
Slovenian: 1 viala
English: Packaging Content Package size
Slovenian: Ovojnina vsebina velikost pakiranja karenca steklena viala 50 ml
English: Subcutaneous use
Slovenian: Govedo Subkutana injekcija
English: Strength Pharmaceutical Form
Slovenian: EU številka izmišljeno ime jakost farmacevtska oblika ciljna živalska vrsta način uporabe zdravila
English: Date of first authorisation: 22nd May 2017
Slovenian: Datum prve odobritve: 22. maj 2017
English: 4.5 Interaction with other medicinal products and other forms of interaction Pharmacodynamic interactions
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Farmakodinamična medsebojna delovanja
English: Treatment effect on the primary composite endpoint, its components and secondary endpoints
Slovenian: Učinek zdravljenja na primarni sestavljeni končni izid, njegove komponente in sekundarne končne izide
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo ali odpadni material je treba zavreči v skladu z lokalnimi predpisi.
English: Visual function
Slovenian: Vidna funkcija
English: Children Ivabradine Accord is not intended for use in children and adolescents younger than 18 years.
Slovenian: Otroci Zdravilo Ivabradine Accord ni namenjeno za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
English: Ivabradine (N=3241) n (%)
Slovenian: Ivabradin (N=3241) n (%)
English: Patients should be informed of signs and symptoms of atrial fibrillation and be advised to contact their physician if these occur.
Slovenian: Bolnike je treba obvestiti o znakih in simptomih atrijske fibrilacije in jim svetovati, da v primeru njihovega pojava obvestijo zdravnika.
English: Spain or
Slovenian: Španija ali
English: In addition, discontinuation of treatment should be considered if there is only limited symptomatic response and when there is no clinically relevant reduction in resting heart rate within three months.
Slovenian: O prekinitvi zdravljenja se mora razmisliti tudi, če obstaja le omejen simptomatski odziv in kadar ni klinično pomembnega znižanja srčne frekvence v mirovanju po 3 mesecih.
English: Outcomes of these evaluations support the lack of environmental risk of ivabradine and ivabradine does not pose a threat to the environment.
Slovenian: Zaključki teh ocen potrjujejo odsotnost tveganja ivabradina za okolje, ivabradin ne predstavlja nevarnosti za okolje.
English: If you think that the effect of Ivabradine Accord is too strong or too weak, talk to your doctor or pharmacist.
Slovenian: Če menite, da je učinek zdravila Ivabradine Accord premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
English: In this way Ivabradine Accord helps to control and reduce the number of angina attacks.
Slovenian: Na ta način zdravilo Ivabradine Accord pripomore k nadzoru in zmanjševanju anginoznih napadov.
English: Ivabradine has no influence on the ability to use machines.
Slovenian: Ivabradin nima vpliva na sposobnost upravljanja strojev.
English: If the combination appears necessary, close cardiac monitoring is needed.
Slovenian: Če se kombinacija zdi potrebna, je treba pozorno spremljati funkcijo srca.
English: Studies in animals have shown reproductive toxicity.
Slovenian: Študije na živalih so pokazale toksičen vpliv na sposobnost razmnoževanja.