natgillin/translations-raw huggingface dataset:
Forkortelser: N = antal personer mITT-population samlet studieperiode, n = antal patienter i undergruppen
Abbreviations: N = number of subjects; mITT population overall study period; n = number of patients in subgroup *HR not computed if number of events < 5 in one treatment group.
I undergruppeanalyser for personer, hvor dosis blev reduceret til 30 mg i Hokusai-VTE-studiet for legemsvægt ≤ 60 kg, moderat nedsat nyrefunktion eller samtidig anvendelse af P-gp-hæmmere, havde 58 (7,9 %) af personerne på dosisreduceret edoxaban 30 mg og 92 (12,8 %) af personerne på warfarin en svær blødning eller CRNM-hændelse [HR (95 %): 0,62 (0,44, 0,86)].
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)].
HR (95 % CI) Første SEE n (%/år)a
First SEE n (%/yr)a
Intraokulær blødning
Intraocular haemorrhage
I undergruppeanalyser med personerne i behandlingsgruppen med 60 mg, hvor dosis var reduceret til 30 mg i ENGAGE AF-TIMI 48-studiet (for legemsvægt ≤ 60 kg, moderat nedsat nyrefunktion eller samtidig anvendelse af P-gp-hæmmere), var hændelsesraten: 2,29 % pr. år for det primære endepunkt sammenlignet med hændelsesraten på 2,66 % pr. år for de matchende personer i warfaringruppen [HR (95 % CI): 0,86 (0,66; 1,13)].
In subgroup analyses, for subjects in the 60 mg treatment group who were dose reduced to 30 mg in the ENGAGE AF-TIMI 48 study (for body weight ≤ 60 kg, moderate renal impairment, or concomitant use of P-gp inhibitors), the event rate was: 2.29% per year for the primary endpoint, compared to the event rate of 2.66% per year for the matching subjects in the warfarin group [HR (95% CI): 0.86 (0.66, 1.13)].
Seponer subkutane antikoagulantia og start behandling med Roteas på tidspunktet for den næste planlagte subkutane antikoagulantiumdosis.
Discontinue subcutaneous anticoagulant and start Roteas at the time of the next scheduled subcutaneous anticoagulant dose.
(140-alder [år]) × vægt [kg] (× 0,85 for kvinder)
(140-age [years]) × weight [kg] (× 0.85 if female) 72 × serum creatinine [mg/dL]
Sådan skal du tage Roteas
How to take Roteas
Seponer Roteas, og start non-VKAantikoagulation på tidspunktet for den næste planlagte dosis Roteas.
Discontinue Roteas and start the non-VKA anticoagulant at the time of the next scheduled dose of Roteas.
• Ketoconazol: Ketoconazol 400 mg en gang dagligt i 7 dage sammen med en enkelt samtidig dosis edoxaban 60 mg på dag 4 forhøjede AUC og Cmax for edoxaban med hhv. 87 % og 89 %.
• Ketoconazole: Ketoconazole 400 mg once daily for 7 days with a single concomitant dose of edoxaban 60 mg on Day 4, increased edoxaban AUC and Cmax by 87% and 89%, respectively.
15 mg filmovertrukne tabletter
15 mg film-coated tablets:
Svære blødninger n (%) n
Major Bleeding n (%) n
Edoxaban forhøjede Cmax for samtidigt administreret digoxin med 28 %.
Edoxaban increased the Cmax of concomitantly administered digoxin by 28%; however, the AUC was not affected.
Startet den
Started on:
For de personer, hvor dosis blev reduceret til 30 mg (hovedsageligt lav legemsvægt eller nyrefunktion) havde 15 (2,1 %) personer, der fik edoxaban og 22 (3,1 %) af de personer, der fik warfarin, recidiverende VTE [HR (95 % CI): 0,69 (0,36; 1,34)].
For the subjects who were dose reduced to 30 mg (predominantly low body weight or renal function) 15 (2.1%) edoxaban and 22 (3.1%) of warfarin subjects had a recurrent VTE [HR (95% CI): 0.69
Indlægsseddel: Information til brugeren Roteas 15 mg filmovertrukne tabletter Roteas 30 mg filmovertrukne tabletter Roteas 60 mg filmovertrukne tabletter
Package leaflet: Information for the user Roteas 15 mg film-coated tablets
Sikkerhed hos patienter med NVAF i ENGAGE AF-TIMI 48
Safety in patients with NVAF in ENGAGE AF-TIMI 48 The primary safety endpoint was major bleeding.
Edoxaban absorberes primært i den øvre del af mave-tarm-kanalen.
Edoxaban is predominantly absorbed in the upper gastrointestinal (GI) tract.
Skift fra Roteas til parenteral antikoagulation (f.eks. heparin) Hold op med at tage Roteas, og start parenteral antikoagulation (f.eks. heparin) på tidspunktet for den næste planlagte dosis Roteas.
Changing from Roteas to parenteral anticoagulants (e.g. heparin) Stop taking Roteas and start the parenteral anticoagulant (e.g. heparin) at the time of the next scheduled dose of Roteas.
Roteas bør anvendes med forsigtighed hos patienter med let til moderat nedsat leverfunktion (se pkt.
Roteas should be used with caution in patients with mild to moderate hepatic impairment (see section 4.4).
Subaraknoid blødning
Subarachnoid haemorrhage
> 50 til ≤ 70 2.093 148 3,31 2.106 171 3,77 0,88 (0,71; 1,10) > 70 til ≤ 90 1.661 108 2,88 1.703 119 3,08 0,93 (0,72; 1,21) > 90 til ≤ 110 927 29
> 50 to ≤ 70 2,093 148 3.31 2,106 171 3.77 0.88 (0.71, 1.10) > 70 to ≤ 90 1,661 108 2.88 1,703 119 3.08 0.93 (0.72, 1.21) > 90 to ≤ 110 927 29
• Erythromycin: Erythromycin 500 mg fire gange dagligt i 8 dage sammen med en enkelt samtidig dosis edoxaban 60 mg på dag 7 forhøjede AUC og Cmax for edoxaban med hhv. 85 % og 68 %.
• Erythromycin: Erythromycin 500 mg four times daily for 8 days with a single concomitant dose of edoxaban 60 mg on Day 7 increased the edoxaban AUC and Cmax by 85% and 68%, respectively.
K-vitaminantagonister, såsom warfarin, acenocoumarol, phenprocoumon eller dabigatran,
• other medicines to reduce blood clotting (e.g. heparin, clopidogrel or vitamin K antagonists such as warfarin, acenocoumarol, phenprocoumon or dabigatran, rivaroxaban, apixaban)
I undergruppeanalyser for personer i behandlingsgruppen med 60 mg, hvor dosis blev reduceret til 30 mg i ENGAGE-AF-TIMI 48 for legemsvægt ≤ 60 kg, moderat nedsat nyrefunktion eller samtidig anvendelse af P-gp-hæmmere, havde 104 (3,05 % pr. år) af de personer, der fik dosisreduceret edoxaban 30 mg, og 166 (4,85 % pr. år) af de personer, der fik dosisreduceret warfarin, en svær blødningshændelse [HR (95 %): 0,63 (0,50; 0,81)].
In subgroup analyses, for subjects in the 60 mg treatment group who were dose reduced to 30 mg in the ENGAGE AF-TIMI 48 study for body weight ≤ 60 kg, moderate renal impairment, or concomitant use of P-gp inhibitors, 104 (3.05% per year) of edoxaban 30 mg dose reduced subjects and 166 (4.85% per year) of warfarin dose reduced subjects had a major bleeding event [HR (95% CI): 0.63 (0.50,
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) 15 mg filmovertrukne tabletter: EU/1/16/1152/001-002
MARKETING AUTHORISATION NUMBER(S) 15 mg film-coated tablets: EU/1/16/1152/001-002 30 mg film-coated tablets: EU/1/16/1152/003-015 60 mg film-coated tablets: EU/1/16/1152/016-028
• Blødning i maven
• Bleeding in the stomach
Seponer Roteas, og start parenteral antikoagulation på tidspunktet for den næste planlagte dosis Roteas.
Discontinue Roteas and start the parenteral anticoagulant at the time of the next scheduled dose of Roteas.
Der findes ikke et specifikt middel, der reverserer den antikoagulerende virkning for edoxaban (se pkt.
A specific anticoagulant reversal agent for edoxaban is not available (see section 4.9).
Roteas 15 mg: Hver tablet indeholder 15 mg edoxaban (som tosilat).
Roteas 15 mg: Each tablet contains 15 mg edoxaban (as tosilate).
15 mg filmovertrukket tablet: Orange, runde filmovertrukne tabletter (6,7 mm diameter) præget med ”DSC L15”.
15 mg film-coated tablet: Orange, round-shaped film-coated tablets (6.7 mm diameter) debossed with “DSC L15”.
Anvendelse af edoxaban sammen med andre P-gp-hæmmere er ikke undersøgt.
The use of edoxaban with other P-gp inhibitors including HIV protease inhibitors has not been studied.
og svært (CrCl < 30 ml/min., men som ikke gennemgår dialyse) nedsat nyrefunktion var forhøjet med hhv. 32 %, 74 % og 72 %, i forhold til personer med normal nyrefunktion (se pkt.
The plasma AUC for subjects with mild (CrCL > 50 - 80 mL/min), moderate (CrCL 30 - 50 mL/min) and severe (CrCL < 30 mL/min but not undergoing dialysis) renal impairment was increased by 32%, 74%, and 72%, respectively, relative to subjects with normal renal function (see section 4.2 for dose reduction).
og svært (CrCl < 30 ml/min., men som ikke gennemgår dialyse) nedsat nyrefunktion var forhøjet med hhv. 32 %, 74 % og 72 % i forhold til personer med normal nyrefunktion.
The plasma AUCs for subjects with mild (CrCL > 50 - 80 mL/min), moderate (CrCL 30 - 50 mL/min) and severe (CrCL < 30 mL/min but not undergoing dialysis) renal impairment were increased by 32%, 74%, and 72%, respectively, relative to subjects with normal renal function.
I det pivotale Hokusai-VTE-studie blev 8.292 personer randomiseret til at få en indledende heparinbehandling (enoxaparin eller ufraktioneret heparin) efterfulgt af edoxaban 60 mg en gang dagligt eller det middel, der sammenlignes med. I den sammenlignende arm blev personer, der fik indledende heparinbehandling samtidigt med warfarin, titreret til et mål for INR på 2,0 til 3,0 efterfulgt af warfarin alene.
In the pivotal Hokusai-VTE study, 8,292 subjects were randomised to receive initial heparin therapy (enoxaparin or unfractionated heparin) followed by edoxaban 60 mg once daily or the comparator.
• Dronedaron: Dronedaron 400 mg to gange dagligt i 7 dage sammen med en enkelt samtidig dosis edoxaban 60 mg på dag 5 forhøjede AUC og Cmax for edoxaban med hhv. 85 % og 46 %.
• Dronedarone: Dronedarone 400 mg twice daily for 7 days with a single concomitant dose of edoxaban 60 mg on Day 5 increased edoxaban AUC and Cmax by 85% and 46%, respectively.
EU/1/16/1152/025 100 filmovertrukne tabletter EU/1/16/1152/026 10 x 1 filmovertrukne tabletter EU/1/16/1152/027 50 x 1 filmovertrukne tabletter EU/1/16/1152/028 100 x 1 filmovertrukne tabletter
EU/1/16/1152/016 10 film-coated tablets EU/1/16/1152/017 14 film-coated tablets EU/1/16/1152/018 28 film-coated tablets EU/1/16/1152/019 30 film-coated tablets EU/1/16/1152/020 56 film-coated tablets EU/1/16/1152/021 60 film-coated tablets EU/1/16/1152/022 84 film-coated tablets EU/1/16/1152/023 90 film-coated tablets EU/1/16/1152/024 98 film-coated tablets EU/1/16/1152/025 100 film-coated tablets EU/1/16/1152/026 10 x 1 film-coated tablets EU/1/16/1152/027 50 x 1 film-coated tablets EU/1/16/1152/028 100 x1 film-coated tablets
Forsøgspersonerne i edoxaban-behandlingsgruppen fik 30 mg en gang dagligt, hvis en eller flere af følgende kliniske faktorer var til stede: moderat nedsat nyrefunktion (CrCl 30-50 ml/min.
Subjects in the edoxaban treatment group received 30 mg once daily if one or more of the following clinical factors were present: moderate renal impairment (CrCL 30 - 50 mL/min), low body weight (≤ 60 kg) or concomitant use of specific P-gp inhibitors.
Roteas 15 mg filmovertrukne tabletter er orange, runde (6,7 mm i diameter) og præget med ”DSC L15 ”på den ene side.
Roteas 15 mg film-coated tablets are orange, round-shaped (6.7 mm diameter) and debossed with “DSC L15” on one side.
Ændring fra parenteral antikoagulation (f.eks. heparin) til Roteas Hold op med at tage antikoagulantia (f.eks. heparin), og start behandling med Roteas på tidspunktet for den næste planlagte antikoagulantia-dosis.
Changing from parenteral anticoagulants (e.g. heparin) to Roteas Stop taking the anticoagulant (e.g. heparin) and start Roteas at the time of the next scheduled anticoagulant dose.
• Blødning i hjernen
• Bleeding in the brain
Roteas 30 mg: Hver tablet indeholder 30 mg edoxaban (som tosilat).
Roteas 30 mg: Each tablet contains 30 mg edoxaban (as tosilate).
Tabel 8: Antal dødelige blødningshændelser pr. kreatininclearance-kategori i ENGAGE AFTIMI 48, sikkerhedsanalyse under behandlinga CrClundergruppe (ml/min.)
Table 8: Number of Fatal Bleeding Events by creatinine clearance category in ENGAGE AFTIMI 48, Safety Analysis On-Treatmenta CrCL subgroup (mL/min)
Edoxaban 30 mg én gang dagligt blev anvendt til personer med en eller flere af de følgende kliniske faktorer: moderat nedsat nyrefunktion (CrCl 30 - 50 ml/min.
Edoxaban 30 mg once daily was used for subjects with one or more of the following clinical factors: moderate renal impairment (CrCL 30 - 50 mL/min); body weight ≤ 60 kg; concomitant use of specific P-gp inhibitors.
LÆGEMIDLETS NAVN Roteas 60 mg filmovertrukne tabletter edoxaban
NAME OF THE MEDICINAL PRODUCT Roteas 60 mg film-coated tablets edoxaban
Hver 15 mg filmovertrukket tablet indeholder 15 mg edoxaban (som tosilat).
Each 15 mg film-coated tablet contains 15 mg edoxaban (as tosilate).
60 mg filmovertrukket tablet: Gule, runde filmovertrukne tabletter (10,5 mm diameter) præget med ”DSC L60”.
60 mg film-coated tablet: Yellow, round-shaped film-coated tablets (10.5 mm diameter) debossed with “DSC L60”.
EU/1/16/1152/012 100 filmovertrukne tabletter EU/1/16/1152/013 10 x 1 filmovertrukne tabletter EU/1/16/1152/014 50 x 1 filmovertrukne tabletter EU/1/16/1152/015 100 x 1 filmovertrukne tabletter
EU/1/16/1152/003 10 film-coated tablets EU/1/16/1152/004 14 film-coated tablets EU/1/16/1152/005 28 film-coated tablets EU/1/16/1152/006 30 film-coated tablets EU/1/16/1152/007 56 film-coated tablets EU/1/16/1152/008 60 film-coated tablets EU/1/16/1152/009 84 film-coated tablets EU/1/16/1152/010 90 film-coated tablets EU/1/16/1152/011 98 film-coated tablets EU/1/16/1152/012 100 film-coated tablets EU/1/16/1152/013 10 x 1 film-coated tablets EU/1/16/1152/014 50 x 1 film-coated tablets EU/1/16/1152/015 100 x1 film-coated tablets
Roteas 60 mg filmovertrukne tabletter er gule, runde (10,5 mm i diameter) og præget med ”DSC L60 ” på den ene side.
Roteas 60 mg film-coated tablets are yellow, round-shaped (10.5 mm diameter) and debossed with “DSC L60” on one side.
Roteas 60 mg: Hver tablet indeholder 60 mg edoxaban (som tosilat).
Roteas 60 mg: Each tablet contains 60 mg edoxaban (as tosilate).
Virkning og anvendelse 2.
What Roteas is and what it is used for 2.
Tabel 9: Antal intrakraniale blødningshændelser pr. kreatininclearance-kategori i ENGAGE AF-TIMI 48, sikkerhedsanalyse under behandlinga CrClundergruppe (ml/min.)
Table 9: Number of Intracranial Bleeding Events by creatinine clearance category in ENGAGE AF-TIMI 48, Safety Analysis On-Treatmenta CrCL subgroup (mL/min)
30 mg filmovertrukket tablet: Lyserøde, runde filmovertrukne tabletter (8,5 mm diameter) præget med ”DSC L30”.
30 mg film-coated tablet: Pink, round-shaped film-coated tablets (8.5 mm diameter) debossed with “DSC L30”.
Hver 30 mg filmovertrukket tablet indeholder 30 mg edoxaban (som tosilat).
Each 30 mg film-coated tablet contains 30 mg edoxaban (as tosilate).
Traumer, forgiftninger og behandlingskomplikationer Blødning på indstiksstedet
Injury, poisoning and procedural complications Surgical site haemorrhage
Behandling af blødning
Management of bleeding
LÆGEMIDLETS NAVN Roteas 30 mg filmovertrukne tabletter edoxaban
NAME OF THE MEDICINAL PRODUCT Roteas 30 mg film-coated tablets edoxaban
LÆGEMIDLETS NAVN Roteas 15 mg filmovertrukne tabletter edoxaban
NAME OF THE MEDICINAL PRODUCT Roteas 15 mg film-coated tablets edoxaban
Hver 60 mg filmovertrukket tablet indeholder 60 mg edoxaban (som tosilat).
Each 60 mg film-coated tablet contains 60 mg edoxaban (as tosilate).
Roteas 30 mg filmovertrukne tabletter er lyserøde, runde (8,5 mm i diameter) og præget med ”DSC L30 ”på den ene side.
Roteas 30 mg film-coated tablets are pink, round-shaped (8.5 mm diameter) and debossed with “DSC L30” on one side.
Roteas 30 mg: hypromellose (E464), macrogol 8000, titandioxid (E171), talcum, carnaubavoks, jernoxid, rød (E172).
Roteas 30 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide red (E172).
Tabel 5: Antal iskæmiske apopleksianfald/SEE pr. kreatininclearance-kategori i ENGAGE AFTIMI 48, mITT-analysesæt, samlet studie
Table 5: Number of Ischaemic Strokes/SEE by creatinine clearance category in ENGAGE AFTIMI 48, mITT Analysis Set Overall Study CrCL subgroup (mL/min)
Roteas 15 mg: Tabletkerne: mannitol (E421), pregelatineret stivelse, crospovidon, hydroxypropylcellulose, magnesiumstearat (E470b).
Roteas 15 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
• Blødning inde i kraniet
• Bleeding inside the skull
I begge behandlingsgrupper med edoxaban fik personerne deres dosis halveret, hvis en eller flere af følgende kliniske faktorer var til stede: moderat nedsat nyrefunktion (CrCl 30 - 50 ml/min.
Subjects in both edoxaban treatment groups had their dose halved if one or more of the following clinical factors were present: moderate renal impairment (CrCL 30 - 50 mL/min), low body weight (≤ 60 kg) or concomitant use of specific P-gp inhibitors (verapamil, quinidine, dronedarone).
Roteas 15 mg: hypromellose (E464), macrogol 8000, titandioxid (E171), talcum, carnaubavoks, jernoxid, rød (E172), jernoxid, gul (E172).
Roteas 15 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide red (E172), iron oxide yellow (E172).
Roteas 60 mg: hypromellose (E464), macrogol 8000, titandioxid (E171), talcum, carnaubavoks, jernoxid, gul (E172).
Roteas 60 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide yellow (E172).
• Blødning i leddene
• Bleeding in joints
Hos patienter med nyresygdom i slutstadiet (end stage renal disease, ESRD) (CrCl < 15 ml/min.)
In patients with end stage renal disease (ESRD) (CrCL < 15 mL/min) or on dialysis, the use of Roteas is not recommended (see sections 4.4 and 5.2).
Roteas 30 mg: Tabletkerne: mannitol (E421), pregelatineret stivelse, crospovidon, hydroxypropylcellulose, magnesiumstearat (E470b).
Roteas 30 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Roteas 60 mg: Tabletkerne: mannitol (E421), pregelatineret stivelse, crospovidon, hydroxypropylcellulose, magnesiumstearat (E470b).
Roteas 60 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP ENHEDSDOSIS-BLISTER (10 x 1) TABLETTER MED 15 MG
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (10 x 1 TABLETS) FOR 15 MG
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER (10 x 1 TABLETTER) MED 60 MG
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (10 x 1 TABLETS) FOR 60 MG
Vaskulære sygdomme Anden blødning
Vascular disorders Other haemorrhage
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER (10 x 1 TABLETTER) MED 30 MG
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (10 x 1 TABLETS) FOR 30 MG
Til patienter, der aktuelt får en 30 mg dosis (ved én eller flere af følgende kliniske faktorer: moderat til svært nedsat nyrefunktion (CrCl 15 - 50 ml/min.
For patients currently on a 30 mg dose (for one or more of the following clinical factors: moderate to severe renal impairment (CrCL 15 - 50 mL/min), low body weight, or use with certain P-gp inhibitors), administer a Roteas dose of 15 mg once daily together with an appropriate VKA dose.
Udseende og pakningsstørrelser
What Roteas looks like and contents of the pack
≥ 30 til ≤ 50 1.302 63 > 50 til ≤ 70 2.093 85 > 70 til ≤ 90 1.661 45 > 90 til ≤ 110 927 27 > 110 til ≤ 130 497 14
≥ 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
Hos patienter med let nedsat nyrefunktion (CrCl > 50 - 80 ml/min.)
In patients with mild renal impairment (CrCL > 50 - 80 mL/min), the recommended dose is 60 mg Roteas once daily.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER MED 14 FILMOVERTRUKNE TABLETTER MED 60 MG
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 14 FILM-COATED TABLETS FOR 60 MG
≥ 30 til ≤ 50 1.302 9 > 50 til ≤ 70 2.093 8 > 70 til ≤ 90 1.661 10 > 90 til ≤ 110 927 2 > 110 til ≤ 130 497 1
≥ 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
Subdural blødning
Subdural haemorrhage
≥ 30 til ≤ 50 1.302 16 > 50 til ≤ 70 2.093 19 > 70 til ≤ 90 1.661 17 > 90 til ≤ 110 927 5 > 110 til ≤ 130 497 2
≥ 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
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER MED 14 FILMOVERTRUKNE TABLETTER MED 30 MG
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 14 FILM-COATED TABLETS FOR 30 MG
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 60 mg edoxaban (som tosilat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 60 mg edoxaban (as tosilate).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 15 mg edoxaban (som tosilat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 15 mg edoxaban (as tosilate).
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER MED 10 FILMOVERTRUKNE TABLETTER MED 15 MG
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 10 FILM-COATED TABLETS FOR 15 MG
p-værdi ICHb n Hændelsesrate (%/år)a
First Ischaemic Stroke n Event Rate (%/yr)b
Samtidig brug af edoxaban og andre P-gp-induktorer (f.eks. phenytoin, carbamazepin,
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.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 30 mg edoxaban (som tosilat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg edoxaban (as tosilate).
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER MED 10 FILMOVERTRUKNE TABLETTER MED 60 MG
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 10 FILM-COATED TABLETS FOR 60 MG
Intraartikulær blødning
Intra-articular haemorrhage
60 mg en gang dagligt*
60 mg QD*
Hvis du har taget for meget Roteas
If you take more Roteas than you should
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER MED 10 FILMOVERTRUKNE TABLETTER MED 30 MG
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 10 FILM-COATED TABLETS FOR 30 MG
Hvis der forekommer svær blødning, skal administration af Roteas seponeres (se pkt.
Roteas administration should be discontinued if severe haemorrhage occurs (see sections 4.8 and 4.9).
Roteas 15 mg filmovertrukne tabletter Roteas 30 mg filmovertrukne tabletter Roteas 60 mg filmovertrukne tabletter
Roteas 30 mg film-coated tablets
Hos patienter med svært nedsat leverfunktion bør Roteas ikke anvendes (se pkt.
In patients with severe hepatic impairment Roteas is not recommended (see sections 4.4 and 5.2).
60 mg en gang dagligt Dosisanbefaling for patienter med en eller flere af følgende kliniske faktorer: Nedsat nyrefunktion Moderat eller svært (CrCl 15 - 50 ml/min.)
60 mg once daily Dose recommendation for patients with one or more of the following clinical factors: Renal Impairment
Nyrer og urinveje Makroskopisk hæmaturi/uretral blødning
Renal and urinary disorders Macroscopic haematuria/urethral haemorrhage
• Kvalme
• Feeling sick
Nedsat nyrefunktion
Procedural haemorrhage
Behandling af DVT, behandling af LE og forebyggelse af tilbagevendende DVT og LE (VTE)
Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTE) 30 mg QD ≥ 30 to ≤ 50
Nedsat leverfunktion Roteas bør ikke anvendes til patienter med svært nedsat leverfunktion (se pkt.
Hepatic impairment Roteas is not recommended in patients with severe hepatic impairment (see sections 4.2 and 5.2).
LÆGEMIDLETS NAVN Roteas 15 mg filmovertrukne tabletter edoxaban NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Berlin-Chemie (logo) UDLØBSDATO
NAME OF THE MARKETING AUTHORISATION HOLDER Berlin-Chemie (logo)
Den fuldstændige EPAR for Ivabradine Accord findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
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.
Ivabradine Accord fås som tabletter (5 og 7,5 mg) og udleveres kun efter recept.
Ivabradine Accord is available as tablets (5 and 7.5 mg) and can only be obtained with a prescription.