FrancophonIA/ELRC3.0 huggingface dataset:
English: Safety in patients with NVAF in ENGAGE AF-TIMI 48 The primary safety endpoint was major bleeding.
Slovenian: Varnost pri bolnikih z NVAF v študiji ENGAGE AF-TIMI 48
English: Edoxaban
Slovenian: Dojenje
English: • Renal function should be assessed in all patients by calculating the creatinine clearance (CrCL) prior to initiation of treatment with Roteas to exclude patients with end stage renal disease (i.e. CrCL < 15 mL/min), to use the correct Roteas dose in patients with CrCL 15 - 50 mL/min (30 mg once daily), in patients with CrCL > 50 mL/min (60 mg once daily) and when deciding on the use of Roteas in patients with increased creatinine clearance (see section 4.4).
Slovenian: (t. j. CrCL < 15 ml/min) in da uporabite pravilen odmerek zdravila Roteas pri bolnikih s CrCL 15 - 50 ml/min (30 mg enkrat na dan) in pri bolnikih s CrCL > 50 ml/min (60 mg enkrat na dan),
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR 30 MG
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (KARTONSKA ŠKATLA) ZA 30 MG
English: Roteas 15 mg: Each tablet contains 15 mg edoxaban (as tosilate).
Slovenian: Roteas 15 mg: ena tableta vsebuje 15 mg edoksabana (v obliki edoksabanijevega tozilata).
English: There is neither scientific rationale for benefit nor experience with the use of systemic haemostatics (desmopressin, aprotinin) in individuals receiving edoxaban.
Slovenian: Koristi uporabe sistemskih hemostatikov (npr. dezmopresina, aprotinina) pri osebah, ki prejemajo edoksaban, niso strokovno utemeljene, prav tako pa ni izkušenj.
English: In a pre-specified subgroup analysis of PE subjects 447 (30.6%) and 483 (32.2%) of edoxaban and warfarin treated subjects, respectively, were identified as having PE and NT-proBNP ≥ 500 pg/mL.
Slovenian: V vnaprej določeni analizi podskupin preiskovancev s PE so za 447 (30,6 %) oziroma 483 (32,2 %)
English: The average exposure to edoxaban 60 mg (including 30 mg dose reduced) was 2.5 years among 7,012 patients in ENGAGE AF-TIMI 48 and 251 days among 4,118 patients in Hokusai-VTE.
Slovenian: 2,5 leta pri 7.012 bolnikih v študiji ENGAGE AF-TIMI 48 in 251 dni pri 4.118 bolnikih v študiji Hokusai-VTE.
English: Posology
Slovenian: PRILOGAI
English: • Verapamil: Verapamil 240 mg once daily for 11 days with a single concomitant dose of edoxaban 60 mg on Day 10 increased the edoxaban AUC and Cmax by approximately 53%.
Slovenian: • Verapamil: verapamil 240 mg enkrat na dan 11 dni z enkratnim sočasnim odmerkom edoksabana 60 mg 10. dne je zvečal AUC in Cmax edoksabana za približno 53 %.
English: • Prescriber Guide for healthcare professionals
Slovenian: • smernice za predpisovanje za zdravstvene delavce; • kartico z opozorili za bolnika.
English: • Concomitant use of the following P-glycoprotein (P-gp) inhibitors: ciclosporin, dronedarone, erythromycin, or ketoconazole.
Slovenian: • sočasna uporaba katerega od naslednjih inhibitorjev P-glikoproteina (P-gp): ciklosporin,
English: Edoxaban 60 mg was non-inferior to warfarin for the primary efficacy endpoint of stroke or SEE (upper limit of the 97.5% CI of the HR was below the pre-specified non-inferiority margin of 1.38) (Table 4).
Slovenian: (zgornja meja 97,5-odstotnegaCI(intervala zaupanja) HR (razmerja tveganja) je bila pod vnaprej določeno mejo neinferiornosti, ki je bila 1,38) (preglednica 4).
English: Each 15 mg film-coated tablet contains 15 mg edoxaban (as tosilate).
Slovenian: Ena 15 mg filmsko obložena tableta vsebuje 15 mg edoksabana (v obliki edoksabanijevega tozilata).
English: The concomitant use of edoxaban with other P-gp inducers (e.g. phenytoin, carbamazepine, phenobarbital or St. John's Wort) may lead to reduced edoxaban plasma concentrations.
Slovenian: Koncentracija edoksabana v plazmi se lahko zmanjša tudi pri sočasni uporabi drugih induktorjev P-gp (npr. fenitoina, karbamazepina, fenobarbitala ali šentjanževke).
English: Continued anticoagulant therapy is important in patients with NVAF and VTE.
Slovenian: Zamenjava zdravila Roteas z drugim zdravilom in obratno Pri bolnikih z NVAF in VTE je pomembna neprekinjena antikoagulantna terapija.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR 15 MG
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (KARTONSKA ŠKATLA) ZA15 MG
English: Platelet inhibitors: In ENGAGE AF-TIMI 48 concomitant use of thienopyridines (e.g. clopidogrel) monotherapy was permitted and resulted in increased clinically relevant bleeding although with a lower risk of bleeding on edoxaban compared to warfarin (see section 4.4).
Slovenian: klopidogrelom) dovoljena in je povzročila zvečano klinično pomembno krvavitev, čeprav z manjšim tveganjem krvavitve pri edoksabanu kot pri varfarinu (glejte poglavje 4.4).
English: Roteas 60 mg: Each tablet contains 60 mg edoxaban (as tosilate).
Slovenian: Roteas 60 mg: ena tableta vsebuje 60 mg edoksabana (v obliki edoksabanijevega tozilata).
English: In a population pharmacokinetic analysis of the ENGAGE AF-TIMI 48 study in NVAF, Cmax and AUC in patients with median low body weight (55 kg) were increased by 40% and 13%, respectively, as compared with patients with median high body weight (84 kg).
Slovenian: pri bolnikih z mediano majhno telesno maso (55 kg) zvečani za 40 % oziroma 13 % v primerjavi z bolniki z mediano veliko telesno maso (84 kg).
English: Roteas 15 mg film-coated tablets are orange, round-shaped (6.7 mm diameter) and debossed with “DSC L15” on one side.
Slovenian: Roteas 15 mg filmsko obložene tablete so oranžne, okrogle,premera 6,7 mm,z vtisnjenim napisom “DSC L15”na eni strani.
English: • other medicines to reduce blood clotting (e.g. heparin, clopidogrel or vitamin K antagonists such as warfarin, acenocoumarol, phenprocoumon or dabigatran, rivaroxaban, apixaban)
Slovenian: varfarin, acenokumarol, fenprokumon ali dabigatran, rivaroksaban, apiksaban),
English: Roteas 30 mg: Each tablet contains 30 mg edoxaban (as tosilate).
Slovenian: Roteas 30 mg: ena tableta vsebuje 30 mg edoksabana (v obliki edoksabanijevega tozilata).
English: Table 5: Number of Ischaemic Strokes/SEE by creatinine clearance category in ENGAGE AFTIMI 48, mITT Analysis Set Overall Study CrCL subgroup (mL/min)
Slovenian: Preglednica 5: Število ishemičnih možganskih kapi/SEE po kategorijah očistka kreatinina v študiji ENGAGE AF-TIMI 48, mITT celotno obdobje študije
English: INFORMATION FOR HEALTHCARE PROFESSIONALS
Slovenian: INFORMACIJE O PREDPISOVALCU
English: Therapy with edoxaban in NVAF patients should be continued long term.
Slovenian: Priporočeni odmerek je 60 mg edoksabanaenkrat na dan. Zdravljenje bolnikov z NVAFz edoksabanomje treba nadaljevati dolgo časa.
English: • Bleeding from the nose
Slovenian: • krvavitev iz nosu, • krvavitev iz nožnice,
English: Co-administration of high dose ASA (325 mg) increased the steady state Cmax and AUC of edoxaban by 35% and 32%, respectively.
Slovenian: je zvečala Cmax in AUC edoksabana v stanju ravnovesja za 35 % oziroma 32 %.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (10 x 1 TABLETS) FOR 60 MG
Slovenian: ENOODMERNI PRETISNI OMOT (10 x 1 TABLETA) ZA 60 MG
English: First Ischaemic Stroke n Event Rate (%/yr)b
Slovenian: Prva ishemična možganska kap n pogostnost dogodka (%/leto)b
English: Each 60 mg film-coated tablet contains 60 mg edoxaban (as tosilate).
Slovenian: Ena 60 mg filmsko obložena tableta vsebuje 60 mg edoksabana (v obliki edoksabanijevega tozilata).
English: Roteas 30 mg film-coated tablets are pink, round-shaped (8.5 mm diameter) and debossed with “DSC L30” on one side.
Slovenian: Roteas 30 mg filmsko obložene tablete so rožnate, okrogle,premera 8,5 mm, z vtisnjenim napisom “DSC L30”na eni strani.
English: Roteas 60 mg film-coated tablets are yellow, round-shaped (10.5 mm diameter) and debossed with “DSC L60” on one side.
Slovenian: Roteas 60 mg filmsko obložene tablete so rumene, okrogle,premera 10,5 mm,z vtisnjenim napisom “DSC L60”na eni strani.
English: apixaban or heparin), except when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open - if you have a liver disease which leads to an increased risk of bleeding - if you have uncontrolled high blood pressure - if you are pregnant or breast feeding
Slovenian: - če imate bolezen jeter, ki lahko zveča tveganje za krvavitve, - če imate nekontroliran visok krvni tlak, - če ste noseči ali dojite.
English: Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTE) The recommended dose is 60 mg edoxaban once daily following initial use of parenteral anticoagulant for at least 5 days (see section 5.1).
Slovenian: Priporočeni odmerek je 60 mg edoksabana enkrat na dan po začetni vsaj 5-dnevni uporabi parenteralnega antikoagulanta (glejte poglavje 5.1).Edoksabana in začetnega parenteralnega antikoagulanta ne smete dajati sočasno.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (10 x 1 TABLETS) FOR 30 MG
Slovenian: ENOODMERNI PRETISNI OMOT (10 x 1 TABLETA) ZA 30 MG
English: The concomitant chronic use of high dose ASA (325 mg) with edoxaban is not recommended.
Slovenian: Sočasna uporaba velikega odmerka ASA (325 mg)
English: Roteas 15 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide red (E172), iron oxide yellow (E172).
Slovenian: Roteas 15 mg:hipromeloza (E464), makrogol 8000, titanov dioksid (E171), smukec, karnauba vosek, rdeči železov oksid (E172), rumeni železov oksid (E172);
English: Adjudicated efficacy cardiovascular mortality per renal subgroups (edoxaban vs. warfarin): CrCL 30 to ≤ 50 mL/min [HR (95% CI): 0.80 (0.65, 0.99)]; CrCL > 50 to < 80 mL/min [HR (95% CI): 0.75 (0.62, 0.90)]; CrCL ≥ 80 mL/min [HR (95% CI): 1.16 (0.92, 1.46)].
Slovenian: 0,80 (0,65; 0,99)]; CrCL > 50 do < 80 ml/min [HR (95 % CI): 0,75 (0,62; 0,90)]; CrCL ≥ 80 ml/min [HR (95 % CI): 1,16 (0,92; 1,46)].
English: Cardiac disorders Pericardial haemorrhage
Slovenian: Srčne bolezni perikardna krvavitev redki
English: Each 30 mg film-coated tablet contains 30 mg edoxaban (as tosilate).
Slovenian: Ena 30 mg filmsko obložena tableta vsebuje 30 mg edoksabana (v obliki edoksabanijevega tozilata).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (10 x 1 TABLETS) FOR 15 MG
Slovenian: ENOODMERNI PRETISNI OMOT (10 x 1 TABLETA) ZA15 MG
English: Abbreviations: ICH = Intracranial Haemorrhage, HR = Hazard Ratio vs. warfarin; CI = Confidence Interval; N = number of subjects in safety population; n = number of events; CRNM = clinically relevant non-major a On-Treatment Period: Time from first dose of study drug to last dose plus 3 days.
Slovenian: Okrajšave:ICH = intrakranialna krvavitev,HR = razmerje tveganja proti varfarinu,CI = interval zaupanja, CRNM = klinično pomembna krvavitev, ki ni bila velika, n = število preiskovancev z dogodki,N = število preiskovancev v populaciji za proučevanje varnosti.
English: Roteas 60 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide yellow (E172).
Slovenian: Roteas 60 mg:hipromeloza (E464), makrogol 8000, titanov dioksid (E171), smukec, karnauba vosek, rumeni železov oksid (E172).
English: Roteas 30 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide red (E172).
Slovenian: Roteas 30 mg:hipromeloza (E464), makrogol 8000, titanov dioksid (E171), smukec, karnauba vosek, rdeči železov oksid (E172);
English: Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany
Slovenian: Glienicker Weg 125
English: Eye disorders Conjunctival/Scleral haemorrhage
Slovenian: Bolezni sečil makroskopska hematurija/uretralna krvavitev pogosti
English: Table 9: Number of Intracranial Bleeding Events by creatinine clearance category in ENGAGE AF-TIMI 48, Safety Analysis On-Treatmenta CrCL subgroup (mL/min)
Slovenian: Preglednica 9: Število intrakranialnih krvavitvenih dogodkov po kategorijah očistka kreatinina v študiji ENGAGE AF-TIMI 48, analiza varnosti med zdravljenjema
English: Concomitant use of Roteas with P-glycoprotein (P-gp) inhibitors In patients concomitantly taking Roteas and the following P-gp inhibitors: ciclosporin, dronedarone, erythromycin, or ketoconazole, the recommended dose is 30 mg Roteas once daily (see section 4.5).
Slovenian: Sočasna uporaba zdravila Roteas z inhibitorji P-glikoproteina (P-gp) Pri bolnikih, ki sočasno jemljejo zdravilo Roteas in naslednje inhibitorje P-gp: ciklosporin,
English: Roteas 15 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Slovenian: Roteas 15 mg: jedro tablete: manitol (E421), predgelirani škrob, krospovidon, hidroksipropilceluloza, magnezijev stearat (E470b);
English: Roteas 60 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Slovenian: Roteas 60 mg: jedro tablete: manitol (E421), predgelirani škrob, krospovidon, hidroksipropilceluloza, magnezijev stearat (E470b).
English: Roteas 30 mg film-coated tablets
Slovenian: Roteas 30 mg filmsko obložene tablete edoksaban
English: Roteas 60 mg film-coated tablets
Slovenian: Roteas60 mg filmsko obložene tablete edoksaban
English: • Roteas is an oral anticoagulant factor Xa inhibitor.
Slovenian: INFORMACIJE ZA ZDRAVSTVENE DELAVCE • Zdravilo Roteas je peroralen zaviralec antikoagulacijskega faktorja Xa.
English: Table 8: Number of Fatal Bleeding Events by creatinine clearance category in ENGAGE AFTIMI 48, Safety Analysis On-Treatmenta CrCL subgroup (mL/min)
Slovenian: Preglednica 8: Število smrtnih krvavitvenih dogodkov po kategorijah očistka kreatinina v študiji ENGAGE AF-TIMI 48, analiza varnosti med zdravljenjema
English: ≥ 30 to ≤ 50 1,302 63 > 50 to ≤ 70 2,093 85 > 70 to ≤ 90 1,661 45 > 90 to ≤ 110 927 27 > 110 to ≤ 130 497 14
Slovenian: ≥ 30 do ≤ 50 1302 63 > 50 do ≤ 70 2093 85 > 70 do ≤ 90 1661 45 > 90 do ≤ 110 927 27 > 110 do ≤ 130 497 14
English: Roteas 30 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Slovenian: Roteas 30 mg: jedro tablete: manitol (E421), predgelirani škrob, krospovidon, hidroksipropilceluloza, magnezijev stearat (E470b);
English: Hepatic impairment Roteas is not recommended in patients with severe hepatic impairment (see sections 4.2 and 5.2).
Slovenian: Okvara jeter Pri bolnikih s hudo okvaro jeter uporabazdravila Roteasni priporočljiva (glejte poglavji 4.2 in 5.2).
English: Table 7: Number of Major Bleeding Events by creatinine clearance category in ENGAGE AFTIMI 48, Safety Analysis On-Treatmenta CrCL subgroup (mL/min)
Slovenian: Preglednica 7: Število velikih krvavitvenih dogodkov po kategorijah očistka kreatinina v študiji ENGAGE AF-TIMI 48, analiza varnosti med zdravljenjema
English: 15 mg film-coated tablet: Orange, round-shaped film-coated tablets (6.7 mm diameter) debossed with “DSC L15”.
Slovenian: Oranžne, okrogle filmsko obložene tablete,premera 6,7 mm, z vtisnjenim napisom “DSC L15”.
English: • Bleeding in the bowel
Slovenian: • izpuščaj, • krvavitev v črevesu,
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 14 FILM-COATED TABLETS FOR 60 MG
Slovenian: PRETISNI OMOT S 14 FILMSKO OBLOŽENIMI TABLETAMI ZA 60 MG
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 14 FILM-COATED TABLETS FOR 30 MG
Slovenian: PRETISNI OMOT S 14 FILMSKO OBLOŽENIMI TABLETAMI ZA 30 MG
English: The duration of therapy for treatment of DVT and PE (venous thromboembolism, VTE), and prevention of recurrent VTE should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see section 4.4).
Slovenian: VTE se določi individualno po skrbni oceni koristi zdravljenja glede na tveganje za krvavitve(glejte poglavje 4.4).
English: Management of bleeding
Slovenian: Ukrepi pri krvavitvah
English: • bleeding disorders
Slovenian: • znotrajlobanjska krvavitev,
English: Body weight For patients with body weight ≤ 60 kg, the recommended dose is 30 mg Roteas once daily (see section
Slovenian: Pri bolnikih s telesno maso ≤ 60 kg je priporočeni odmerek 30 mg zdravila Roteas enkrat na dan (glejte poglavje 5.2).
English: ≥ 30 to ≤ 50 1,302 16 > 50 to ≤ 70 2,093 19 > 70 to ≤ 90 1,661 17 > 90 to ≤ 110 927 5 > 110 to ≤ 130 497 2
Slovenian: ≥ 30 do ≤ 50 1302 16 > 50 do ≤ 70 2093 19 > 70 do ≤ 90 1661 17 > 90 do ≤ 110 927 5 > 110 do ≤ 130 497 2
English: Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).
Slovenian: GVT in PE pri odraslih (za hemodinamično nestabilne bolnike s PE glejte poglavje 4.4).
English: Immune system disorders Hypersensitivity
Slovenian: Bolezni imunskega sistema preobčutljivost občasni anafilaktična reakcija redki alergijski edem redki
English: First Haemorrhagic Stroke n Event Rate (%/yr)b
Slovenian: Prva hemoragična možganska kap n pogostnost dogodka (%/leto)b
English: • severe liver disease
Slovenian: • huda bolezen jeter, • motnje strjevanja krvi,
English: 60 mg film-coated tablet: Yellow, round-shaped film-coated tablets (10.5 mm diameter) debossed with “DSC L60”.
Slovenian: Rumene, okrogle filmsko obložene tablete, premera 10,5 mm, z vtisnjenim napisom “DSC L60”.
English: The primary efficacy outcome occurred in 14 (3.1%) and 30 (6.2%) of edoxaban and warfarin subjects, respectively [HR (95% CI): 0.50 (0.26, 0.94)].
Slovenian: preiskovancih, ki so prejemali edoksaban oziroma varfarin [HR (95 % CI): 0,50 (0,26, 0,94)].
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Edoksaban se absorbira pretežno v zgornjemgastrointestinalnem (GI) traktu.
English: NAME OF THE MEDICINAL PRODUCT Roteas 15 mg film-coated tablets edoxaban
Slovenian: Roteas15 mg filmsko obložene tablete edoksaban
English: Phone number, practice stamp:
Slovenian: Telefonska številka, žig ambulante: Podpis zdravnika:
English: Not applicable.
Slovenian: ki ni bila velika).
English: • The signs or symptoms of bleeding and when to seek attention
Slovenian: Kartica z opozorili za bolnika mora vsebovati naslednja ključna varnostna sporočila: • o znakih ali simptomih krvavitve in o tem, kdaj je treba poiskati zdravniško pomoč;
English: Do not take Roteas if you are pregnant or breast-feeding.
Slovenian: Nosečnost in dojenje Ne jemljite zdravila Roteas, če ste noseči ali dojite.
English: • antidepressant medicines called selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors
Slovenian: • antidepresive, imenovane selektivni zaviralci privzema serotonina ali zaviralci privzema serotonina in noradrenalina, se posvetujte z zdravnikom, preden boste začeli jemati zdraviloRoteas, ker zgoraj navedena zdravila lahko zvečajo učinke zdravila Roteasin možnost neželene krvavitve.
English: Roteas film-coated tablets edoxaban
Slovenian: Zdravilo Roteas filmsko-obložene tablete edoksaban
English: Haemoptysis
Slovenian: Edoksaban
English: Hydroxypropylcellulose Magnesium stearate (E470b)
Slovenian: Jedro tablete: manitol (E421) predgelirani škrob krospovidon hidroksipropilceluloza magnezijev stearat (E470b)
English: No dose reduction is required for concomitant use of amiodarone, quinidine or verapamil (see section
Slovenian: Pri sočasni uporabi amiodarona, kinidina ali verapamila ni potrebno nikakršno zmanjševanje odmerka
English: • Bleeding in joints
Slovenian: • krvavitev v sklepih,
English: It is very important to take Roteas before and after the operation exactly at the times you have been told by your doctor.
Slovenian: Zelo pomembno je, da zdravilo Roteas pred kirurškim posegom in po njem jemljete natančno ob predpisanem času, kot vam je svetoval zdravnik.Če je mogoče, nehajte jemati zdravilo Roteas vsaj 24 ur pred operacijo.
English: Subarachnoid haemorrhage
Slovenian: občasni subarahnoidna krvavitev redki
English: Please talk to your doctor if you experience any unusual symptoms.
Slovenian: Če opazite kateri koli nenavaden simptom, se pogovorite z zdravnikom.
English: 30 mg film-coated tablet: Pink, round-shaped film-coated tablets (8.5 mm diameter) debossed with “DSC L30”.
Slovenian: Rožnate, okrogle filmsko obložene tablete, premera 8,5 mm, z vtisnjenim napisom “DSC L30”.
English: 60 mg QD*
Slovenian: 60 mg enkrat na dan*
English: Retroperitoneal haemorrhage
Slovenian: Navzea pogosti retroperitonealna krvavitev redki
English: • Bleeding from the skin or under the skin
Slovenian: • nenormalni izvidi krvnih preiskav delovanja jeter, • krvavitve v koži ali pod kožo,
English: Changing from Roteas to non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban) Stop taking Roteas and start the non-VKA anticoagulant (e.g. dabigatran, rivaroxaban, or apixaban) at the time of the next scheduled dose of Roteas.
Slovenian: Prehod s peroralnih antikoagulantov, ki niso antagonisti vitamina K (dabigatran, rivaroksabanali apiksaban)na zdraviloRoteas
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 10 FILM-COATED TABLETS FOR 60 MG
Slovenian: PRETISNI OMOT Z 10 FILMSKO OBLOŽENIMI TABLETAMI ZA 60 MG
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 10 FILM-COATED TABLETS FOR 30 MG
Slovenian: PRETISNI OMOT Z 10 FILMSKO OBLOŽENIMI TABLETAMI ZA 30 MG
English: Changing from non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban) to Roteas Stop taking the previous medicines (e.g. dabigatran, rivaroxaban, or apixaban) and start Roteas at the time of the next scheduled dose.
Slovenian: dabigatran, rivaroksaban ali apiksaban)in začnite jemati zdraviloRoteasob času naslednjega načrtovanega odmerka.
English: Upper GI haemorrhage
Slovenian: Okvara jeter
English: • anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
Slovenian: naproksen ali acetilsalicilno kislino),
English: In subgroup analyses, for subjects who were dose reduced to 30 mg in the Hokusai-VTE study for body weight ≤ 60 kg, moderate renal impairment, or concomitant use of P-gp inhibitors, 58 (7.9%) of edoxaban 30 mg dose reduced subjects and 92 (12.8%) of warfarin subjects had a major bleeding or CRNM event [HR (95%): 0.62 (0.44, 0.86)].
Slovenian: 58 (7,9 %) preiskovancev, ki so prejemali zmanjšan odmerek edoksabana 30 mg, in 92 (12,8 %) preiskovancev, ki so prejemali varfarin, veliko krvavitev ali CRNM dogodek [HR (95 %): 0,62
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 10 FILM-COATED TABLETS FOR 15 MG
Slovenian: PRETISNI OMOT Z 10 FILMSKO OBLOŽENIMI TABLETAMI ZA15 MG
English: Common (may affect up to 1 in 10 people):
Slovenian: Celoten seznam možnih neželenih učinkov: Pogosti(pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: ≥ 30 to ≤ 50 1,302 9 > 50 to ≤ 70 2,093 8 > 70 to ≤ 90 1,661 10 > 90 to ≤ 110 927 2 > 110 to ≤ 130 497 1
Slovenian: > 50 do ≤ 70 2093 8 > 70 do ≤ 90 1661 10 > 90 do ≤ 110 927 2 > 110 do ≤ 130 497 1
English: Recommended dose
Slovenian: - Navodilo shranite.
English: Changing from Roteas to vitamin K antagonists (e.g. warfarin) If you currently take 60 mg Roteas:
Slovenian: varfarin) Če trenutno jemljete 60 mg zdravila Roteas:
English: Discontinue Roteas and start the parenteral anticoagulant at the time of the next scheduled dose of Roteas.
Slovenian: Teh zdravil ne smete uporabljati sočasno.Ukinite zdravilo Roteas in začnite s parenteralnim antikoagulantom ob času naslednjega načrtovanega odmerka zdravila Roteas.
English: Hepatic impairment
Slovenian: • glavobol,
English: When used for angina, treatment should be stopped if symptoms do not improve after 3 months.
Slovenian: Kadar se uporablja za zdravljenje angine pektoris, je treba zdravljenje prekiniti, če se simptomi po 3 mesecih ne izboljšajo.
English: In stable angina, these symptoms occur during physical effort.
Slovenian: Pri stabilni angini pektoris se ti simptomi pojavijo med telesnim naporom.
English: The full EPAR for Ivabradine Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ivabradine Accord je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.