natgillin/translations-raw huggingface dataset:
Hos PLATO-patienter, der fik foretaget koronar bypassoperation (CABG), havde ticagrelor flere blødninger end clopidogrel, når behandlingen blev seponeret inden for et døgn før indgrebet, men samme incidens af større blødninger sammenlignet med clopidogrel efter seponering af behandlingen to eller flere dage før indgrebet (se pkt.
In PLATO patients undergoing coronary artery bypass grafting (CABG), ticagrelor had more bleeding than clopidogrel when stopped within 1 day prior to surgery but a similar rate of major bleeds compared to clopidogrel after stopping therapy 2 or more days before surgery (see section 4.8).
Brugen af ticagrelor er kontraindiceret hos patienter med aktiv patologisk blødning, hos patienter med intrakraniel blødning i anamnesen og hos patienter med svært nedsat leverfunktion (se pkt.
The use of ticagrelor is contraindicated in patients with active pathological bleeding, in those with a history of intracranial haemorrhage, and in patients with severe hepatic impairment (see section 4.3).
Inhiberingen af ticagrelors blodpladeaggregering (IPA) var uafhængig af dialyse hos patienter med nyresygdom i slutstadiet og lignede den hos personer med normal nyrefunktion (se pkt.
The inhibition of platelet aggregation (IPA) effect of ticagrelor was independent of dialysis in patients with end stage renal disease and similar to subjects with normal renal function (see section 4.2).
Brilique indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natriumfrit.
Brilique contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free'.
Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Der er ikke behov for nogen dosisjustering for patienter med let nedsat leverfunktion.
No dose adjustment is needed for patients with mild hepatic impairment.
Major Fatal/Life-threatening Bleed: Klinisk åbenbar med en reduktion på >50 g/l af hæmoglobin eller ≥4 infunderede erytrocytenheder; eller fatal; eller intrakraniel; eller intraperikardiel med hjertetamponade; eller med hypovolæmisk shock eller svær hypotension, der kræver pressorstoffer eller operation.
Major Fatal/Life-threatening Bleed: Clinically apparent with >50 g/L decrease in haemoglobin or ≥4 red cell units transfused; or fatal; or intracranial; or intrapericardial with cardiac tamponade; or with hypovolaemic shock or severe hypotension requiring pressors or surgery.
RRR for det sammensatte endepunkt fra 1 til 360 dage (17 % RRR) og fra 361 dage og derover (16 % RRR) var ens. Der er begrænsede data om virkning og sikkerhed for ticagrelor ud over 3 års udvidet behandling.
The RRR for the composite endpoint from 1 to 360 days (17% RRR) and from 361 days and onwards (16% RRR) was similar.
• Perforerede enkeltdosis-blisterkort i æsker med 10x1, 56x1, 60x1 smeltetabletter.
• perforated unit dose blisters in cartons of 10 x 1, 56 x 1 and 60 x 1 orodispersible tablets.
Brilique indeholder • Aktivt stof: ticagrelor.
What Brilique contains • The active substance is ticagrelor.
Der sås højere eksponeringer for ticagrelor (ca. 25 % for både Cmax og AUC) og den aktive metabolit hos ældre forsøgspersoner (≥75 år) AKS-patienter sammenlignet med yngre forsøgspersoner.
Higher exposures to ticagrelor (approximately 25% for both Cmax and AUC) and the active metabolite were observed in elderly (≥75 years) ACS patients compared to younger patients by the population pharmacokinetic analysis.
Den forventede virkning af for høj dosering med ticagrelor er, at den blødningsrisiko, der er forbundet med trombocythæmning, vil vare længere.
The expected effect of excessive ticagrelor dosing is prolonged duration of bleeding risk associated with platelet inhibition.
Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen med ticagrelor for at undgå graviditet.
Women of childbearing potential should use appropriate contraceptive measures to avoid pregnancy during ticagrelor therapy.
Ticagrelor 90 mg to gange dagligt (% patienter med hændelse) N=9333
Ticagrelor 90 mg twice daily (% patients with event) N=9333
• Øvrige indholdsstoffer: mannitol (E421), mikrokrystallinsk cellulose (E460), crospovidon (E1202), xylitol (E967), vandfrit kalciumhydrogenphosphat (E341), natriumstearylfumarat, hydroxyproylcellulose (E463), kolloidt vandfrit silica.
• The other ingredients are: mannitol (E421), microcrystalline cellulose (E460), crospovidone (E1202), xylitol (E967), anhydrous calcium hydrogen phosphate (E341), sodium stearyl fumarate, hydroxypropylcellulose (E463), colloidal anhydrous silica.
Der var imidlertid ingen evidens af klinisk signifikante bivirkninger i PLATO-studiet efter samtidig administration af ét eller flere lægemidler, kendt for at inducere bradykardi (f.eks. 96 % betablokkere, 33 % calciumantagonister diltiazem og verapamil og 4 % digoxin).
However, no evidence of clinically significant adverse reactions was observed in the PLATO trial after concomitant administration with one or more medicinal products known to induce bradycardia (e.g. 96% beta blockers, 33% calcium channel blockers diltiazem and verapamil and 4% digoxin).
Meget almindelig
SOC Very common Common
De tilsvarende tal for urinsyregigt/podagra i PEGASUS var 1,6 %, 1,5 % og 1,1 % for henholdsvis ticagrelor 90 mg, 60 mg og placebo.
The corresponding numbers for gout/gouty arthritis in PEGASUS were 1.6%, 1.5% and 1.1% for ticagrelor 90 mg, 60 mg and placebo, respectively.
14 filmovertrukne tabletter 56 filmovertrukne tabletter 60 filmovertrukne tabletter 100x1 filmovertrukne tabletter 168 filmovertrukne tabletter 180 filmovertrukne tabletter
14 film-coated tablets 56 film-coated tablets 60 film-coated tablets 100x1 film-coated tablets 168 film-coated tablets 180 film-coated tablets
Der var dog ingen evidens af klinisk signifikante bivirkninger i PLATO-studiet efter samtidig administration af et eller flere lægemidler, der er kendt for at inducere bradykardi (f.eks. 96 % betablokkere, 33 % calciumantagonister (diltiazem og verapamil) og 4 % digoxin) (se pkt.
However, no evidence of clinically significant adverse reactions was observed in the PLATO trial after concomitant administration with one or more medicinal products known to induce bradycardia (e.g. 96% beta blockers, 33% calcium channel blockers diltiazem and verapamil and 4% digoxin) (see section 4.5).
Brilique, der administreres sammen med acetylsalicylsyre (ASA), er indiceret til forebyggelse af aterotrombotiske hændelser hos voksne patienter med - akut koronart syndrom (AKS) eller - myokardieinfarkt (MI) i anamnesen og en høj risiko for at udvikle en aterotrombotisk hændelse (se pkt.
Brilique, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with - acute coronary syndromes (ACS) or - a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event (see sections 4.2 and 5.1).
• PVC-PVDC/Al gennemsigtige kalender-blisterkort (med sol/måne-symbol) a 14 tabletter i æsker med 14 tabletter (1 blisterkort), 56 tabletter (4 blisterkort) og 168 tabletter (12 blisterkort).
• PVC-PVDC/Al transparent calendar blister (with sun/moon symbols) of 14 tablets; cartons of 14 tablets (1 blister), 56 tablets (4 blisters) and 168 tablets (12 blisters).
I kliniske studier blev ticagrelor ofte administreret sammen med ASA, syrepumpehæmmere, statiner, betablokkere, angiotensinkonverterende enzymhæmmere (ACE-hæmmere) og angiotensin IIreceptorantagonister efter behov for samtidige sygdomme gennem længere tid og ligeledes sammen med heparin, lavmolekylært heparin og intravenøse GpIIb/IIIa-hæmmere i kortere tid (se pkt.
In clinical studies, ticagrelor was commonly administered with ASA, proton pump inhibitors, statins, beta-blockers, angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers as needed for concomitant conditions for long-term and also heparin, low molecular weight heparin and intravenous GpIIb/IIIa inhibitors for short durations (see section 5.1).
Trombotisk trombocytopenisk purpura
Thrombotic Thrombocytopenic Purpura
Blødning post procedure, Traumatiske blødninger f.eks. blødning fra blærecancer, mavecancer, tarmcancer f.eks. øget risiko for blå mærker, spontane hæmatomer, hæmoragisk diatese Identificeret efter markedsføring d
Post procedural haemorrhage, Traumatic bleedings e.g. bleeding from bladder cancer, gastric cancer, colon cancer e.g. increased tendency to bruise, spontaneous haematoma, haemorrhagic diathesis Identified in post-marketing experience d
Effekten af behandling med ticagrelor i forhold til clopidogrel synes at være konsistent på tværs af mange undergrupper, herunder vægt; køn; anamnese med diabetes mellitus, transitorisk iskæmisk attak eller non-hæmoragisk apopleksi eller revaskularisering; samtidige behandlinger herunder hepariner, GpIIb/IIIa-hæmmere og syrepumpehæmmere (se pkt.
The treatment effect of ticagrelor over clopidogrel appears consistent across many subgroups, including weight; sex; medical history of diabetes mellitus, transient ischaemic attack or non-haemorrhagic stroke, or revascularisation; concomitant therapies including heparins, GpIIb/IIIa inhibitors and proton pump inhibitors (see section 4.5); final index event diagnosis (STEMI, NSTEMI or UA); and treatment pathway intended at randomisation (invasive or medical).
PLATO Major Fatal/life-threatening: Fatal blødning, ELLER en intrakraniel blødning, ELLER intraperikardiel med hjertetamponade, ELLER med hypovolæmisk shock eller svær hypotension, der kræver pressorstoffer/inotroper eller operation ELLER klinisk åbenlys med >50 g/l fald i hæmoglobin eller ≥4 infunderede erytrocytenheder.
PLATO Major Fatal/life-threatening: Fatal bleeding, OR any intracranial bleeding, OR intrapericardial with cardiac tamponade, OR with hypovolaemic shock or severe hypotension requiring pressors/inotropes or surgery OR clinically apparent with >50 g/L decrease in haemoglobin or ≥4 red cell units transfused.
Ticagrelor bør anvendes med forsigtighed til patienter med astma og/eller KOL i anamnesen (se pkt.
Ticagrelor should be used with caution in patients with history of asthma and/or COPD (see section 4.4).
Myokardieinfarkt i anamnesen
History of myocardial infarction
Ticagrelor 60 mg to gange dagligt + ASA N=6958
Ticagrelor 60 mg twice daily + ASA N=6958
f.eks. konjunktival, retinal, intraokulær blødning f.eks. epistaksis, hæmoptyse f.eks. gingival blødning, rektal blødning, blødende gastrisk ulcus f.eks. ekkymose, blødning i huden, petekkier f.eks. hæmartrose, muskelblødning f.eks. hæmaturi, hæmoragisk cystitis f.eks. vaginal blødning, hæmatospermi, postmenopausal blødning f.eks. kontusion, traumatisk hæmatom, traumatisk blødning
e.g. conjunctival, retinal, intraocular bleeding e.g. epistaxis, haemoptysis e.g. gingival bleeding, rectal haemorrhage, gastric ulcer haemorrhage e.g. ecchymosis, skin haemorrhage, petechiae e.g. haemarthrosis, muscle haemorrhage e.g. haematuria, cystitis haemorrhagic e.g. vaginal haemorrhage, haematospermia, postmenopausal haemorrhage e.g. contusion, traumatic haematoma, traumatic haemorrhage
Ikke koronar-bypass (non-CABG)-relateret blødning og ikke-procedurerelateret blødning: Der var ingen forskel ticagrelor og clopidogrel imellem mht. non-CABG PLATO-defineret Major Fatal/Life-threatening bleeding, mens PLATO-definerede Total Major, TIMI Major og TIMI Major + Minor bleeding var mere almindelige med ticagrelor.
Ticagrelor and clopidogrel did not differ in non-CABG PLATO-defined Major Fatal/Lifethreatening bleeding, but PLATO-defined Total Major, TIMI Major, and TIMI Major + Minor bleeding were more common with ticagrelor.
Brilique fås i:
Brilique is available in:
PLATO-definerede blødningskategorier PLATO Major
PLATO-defined bleeding categories
• Blødning fra mavens slimhinde (mavesår)
• Bleeding from your stomach lining (ulcer)
Ticagrelor 60 mg to gange dagligt +ASA N = 7045
Ticagrelor 60 mg twice daily +ASA N = 7045
TIMI Major Bleed: Klinisk åbenbar med en reduktion på >50 g/l af hæmoglobin eller intrakraniel blødning.
TIMI Major Bleed: Clinically apparent with >50 g/L decrease in haemoglobin or intracranial haemorrhage.
Lægemidler, der er kendt for at inducere bradykardi På grund af observationer af hovedsagelig asymptomatiske ventrikulære pauser og bradykardi bør der udvises forsigtighed i forbindelse med samtidig administration af ticagrelor og lægemidler, der vides at inducere bradykardi (se pkt.
Due to observations of mostly asymptomatic ventricular pauses and bradycardia, caution should be exercised when administering ticagrelor concomitantly with medicinal products known to induce bradycardia (see section 4.4).
Blødningsrisiko Brugen af ticagrelor hos patienter med kendt øget risiko for blødning afvejes mod fordelene ved forebyggelse af aterotrombotiske hændelser (se pkt.
Bleeding risk The use of ticagrelor in patients at known increased risk for bleeding should be balanced against the benefit in terms of prevention of atherothrombotic events (see sections 4.8 and 5.1).
Ticagrelor havde ingen indvirkning på ciclosporins blodkoncentration.
There was no effect of ticagrelor on cyclosporine blood levels.
Samtidig administration af ciclosporin (600 mg) og ticagrelor øgede ticagrelors Cmax og AUC svarende til hhv. 2,3 gange og 2,8 gange.
Co-administration of cyclosporine (600 mg) with ticagrelor increased ticagrelor Cmax and AUC equal to 2.3-fold and 2.8-fold, respectively.
RRR (95 % CI)
RRR a (%) (95% CI)
10 x 1 smeltetablet 56 x 1 smeltetablet 60 x 1 smeltetablet
10 x 1 orodispersible tablets 56 x 1 orodispersible tablets 60 x 1 orodispersible tablets
Kreatininforhøjelser
Creatinine elevations
EU/1/10/655/007 14 filmovertrukne tabletter EU/1/10/655/008 56 filmovertrukne tabletter EU/1/10/655/009 60 filmovertrukne tabletter EU/1/10/655/010 168 filmovertrukne tabletter EU/1/10/655/011 180 filmovertrukne tabletter
EU/1/10/655/007 14 film-coated tablets EU/1/10/655/008 56 film-coated tablets EU/1/10/655/009 60 film-coated tablets EU/1/10/655/010 168 film-coated tablets EU/1/10/655/011 180 film-coated tablets
EU/1/10/655/012 10x1 smeltetabletter EU/1/10/655/013 56 x 1 smeltetabletter EU/1/10/655/014 60 x 1 smeltetabletter
EU/1/10/655/012 10 x 1 orodispersible tablets EU/1/10/655/013 56 x 1 orodispersible tablets EU/1/10/655/014 60 x 1 orodispersible tablets
EU/1/10/655/001 60 filmovertrukne tabletter EU/1/10/655/002 180 filmovertrukne tabletter EU/1/10/655/003 14 filmovertrukne tabletter EU/1/10/655/004 56 filmovertrukne tabletter EU/1/10/655/005 168 filmovertrukne tabletter EU/1/10/655/006 100x1 filmovertrukne tabletter
EU/1/10/655/001 60 film-coated tablets EU/1/10/655/002 180 film-coated tablets EU/1/10/655/003 14 film-coated tablets EU/1/10/655/004 56 film-coated tablets EU/1/10/655/005 168 film-coated tablets EU/1/10/655/006 100x1 film-coated tablets
Det nedsætter risikoen for, at du får endnu et hjerteanfald, slagtilfælde eller at du dør som følge af en hjertekarsygdom.
It reduces the chances of you having another heart attack, stroke or dying from a disease related to your heart or blood vessels.
Tabletkerne: mannitol (E421), calciumhydrogenphosphatdihydrat, natriumstivelsesglycolat type A, hydroxypropylcellulose (E463), magnesiumstearat (E470b).
Tablet core: mannitol (E421), calcium hydrogen phosphate dihydrate, sodium starch glycolate type A, hydroxypropylcellulose (E463), magnesium stearate (E470b).
TIMI-definerede blødningskategorier TIMI Major
TIMI-defined bleeding categories
Tablettens filmovertræk: hypromellose (E464), titandioxid (E171), talcum, macrogol 400, jernoxid, gul (E172).
Tablet film-coating: hypromellose (E464), titanium dioxide (E171), talc, macrogol 400, iron oxide yellow (E172).
• Anden medicin såsom ketoconazol (mod svampeinfektioner), clarithromycin (mod bakterielle infektioner), nefazodon (mod depression), ritonavir og atazanavir (mod hiv-infektion og aids),
• other medicines such as ketoconazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used to treat HIV infection and AIDS), cisapride (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches).
Biotilgængeligheden af ticagrelor og de aktive metabolitter for knuste tabletter, blandet i vand, givet oralt eller administreret gennem en nasogastrisk sonde ned til maven, er sammenlignelig med biotilgængeligheden af de hele filmovertrukne tabletter med hensyn til AUC og Cmax.
Ticagrelor as crushed tablets mixed in water, given orally or administered through a nasogastric tube into the stomach, has a comparable bioavailability to whole tablets with regards to AUC and Cmax for ticagrelor and the active metabolite.
• Blødende tandkød
• Bleeding gums
Calciumhydrogenphosphatdihydrat Magnesiumstearat (E470b) Natriumstivelsesglycolat type A Hydroxypropylcellulose (E463)
Calcium hydrogen phosphate dihydrate Magnesium stearate (E470b) Sodium starch glycolate type A Hydroxypropylcellulose (E463)
Ticagrelor 90 mg to gange dagligt N=9235
Ticagrelor 90 mg twice daily N=9235
• Moderate CYP3A4-hæmmere - Samtidig administration af diltiazem og ticagrelor øgede ticagrelors Cmax med 69 % og AUC 2,7 gange og reducerede den aktive metabolits Cmax med 38 %.
• Moderate CYP3A4 inhibitors - Co-administration of diltiazem with ticagrelor increased the ticagrelor Cmax by 69% and AUC to 2.7-fold and decreased the active metabolite Cmax by 38% and AUC was unchanged.
Brugen af ticagrelor hos patienter med kendt øget risiko for blødning afvejes mod fordelene ved forebyggelse af aterotrombotiske hændelser (se pkt.
The use of ticagrelor in patients at known increased risk for bleeding should be balanced against the benefit in terms of prevention of atherothrombotic events (see sections 4.8 and 5.1).
Der er begrænset erfaring med ticagrelor til patienter med moderat nedsat leverfunktion, og derfor bør der udvises forsigtighed ved disse patienter (se pkt.
There is limited experience with ticagrelor in patients with moderate hepatic impairment, therefore, caution is advised in these patients (see sections 4.2 and 5.2).
• PVC-PVDC-Al perforerede, gennemsigtige blisterkort med enkeltdoseringer a 10 tabletter i æsker med 100x1 tabletter (10 blisterkort).
• PVC-PVDC/Al perforated unit dose transparent blister of 10 tablets; cartons of 100x1 tablets (10 blisters).
Stigningen i ventrikulære pauser i den akutte fase af et AKS var mere udtalt for ticagrelor-patienter med symptomatisk hjerteinsufficiens i anamnesen (9,2 % versus 5,4 % af patienter uden anamnestisk hjerteinsufficiens.
The increase in ventricular pauses in the acute phase of ACS was more pronounced in ticagrelor patients with history of CHF (9.2% versus 5.4% in patients without CHF history; for clopidogrel patients, 4.0% in those with versus 3.6% in those without CHF history).
CYP3A4-induktorer
CYP3A inducers
Således kan Brilique 90 mg to gange dagligt anvendes sammen med en lav dosis ASA til patienter med AKS (ustabil angina, non-STelevationsmyokardieinfarkt [NSTEMI] eller ST-elevationsmyokardieinfarkt [STEMI].
Thus, Brilique 90 mg twice daily together with low-dose ASA can be used in patients with ACS (unstable angina, non-ST elevation Myocardial Infarction [NSTEMI] or ST elevation Myocardial Infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG).
Major Other: Klinisk åbenbar med en reduktion på 30-50 g/l af hæmoglobin eller 2-3 infunderede erytrocytenheder eller svært invaliderende.
Major Other: Clinically apparent with 30-50 g/L decrease in haemoglobin or 2-3 red cell units transfused; or significantly disabling.
TIMI Minor: Klinisk åbenlys med 30-50 g/l fald i hæmoglobin.
TIMI Minor: Clinically apparent with 30-50 g/L decrease in haemoglobin.
Tilfælde af svimmelhed og forvirring er indberettet under behandling med ticagrelor.
During treatment with ticagrelor, dizziness and confusion have been reported.
Vandfrit calciumhydrogenphosphat (E341) Natriumstearylfumarat Hydroxypropylcellulose (E463) Kolloid vandfri silica
Anhydrous calcium hydrogen phosphate (E341) Sodium stearyl fumarate Hydroxypropylcellulose (E463) Colloidal anhydrous silica
Der skal udvises forsigtighed ved patienter med en anamnese med hyperurikæmi eller podagra.
Caution is advised in patients with history of hyperuricaemia or gouty arthritis.
Tabletovertræk Titandioxid (E171) Sort jernoxid (E172) Rød jernoxid (E172) Macrogol 400
Tablet coating Titanium dioxide (E171) Iron oxide black (E172) Iron oxide red (E172) Macrogol 400
PLATO Major Other: Signifikant invaliderende, ELLER klinisk åbenlys med 30-50 g/l fald i hæmoglobin, ELLER 2-3 infunderede erytrocytenheder.
PLATO Major Other: Significantly disabling, OR clinically apparent with 30-50 g/L decrease in haemoglobin, OR 2-3 red cell units transfused.
Gastrointestinal blødning g, diarré, kvalme, dyspepsi, obstipation
Diarrhoea, Nausea, Dyspepsia, Constipation
Titandioxid (E171) Jernoxid, gul (E172) Macrogol 400
Titanium dioxide (E171) Iron oxide yellow (E172) Macrogol 400
Nedsat nyrefunktion Dosisjustering er ikke nødvendig for patienter med nyreinsufficiens (se pkt.
Renal impairment No dose adjustment is necessary for patients with renal impairment (see section 5.2).
Tablettens filmovertræk: hypromellose (E464), titandioxid (E171), macrogol 400, jernoxid, sort (E172), jernoxid, rød (E172).
Tablet film-coating: hypromellose (E464), titanium dioxide (E171), macrogol 400, iron oxide black (E172), iron oxide red (E172).
CV-dødsfald/MI i alt/apopleksi/SRI/RI/ TIA eller andre ATE
CV death, total MI, stroke, SRI, RI, TIA or other ATE All-cause mortality Definite stent thrombosis
Koronar bypass-relateret (CABG) blødning:
CABG-related bleeding:
Runde, bikonvekse, lyserøde tabletter præget med "60" over "T" på den ene side og glat på den anden.
Round, biconvex, pink tablets marked with ‘60' above ‘T' on one side and plain on the other.
TIMI Minor Bleed: Klinisk åbenbar med en reduktion på 30-50 g/l af hæmoglobin.
TIMI Minor Bleed: Clinically apparent with 30-50 g/L decrease in haemoglobin.
Studiet skulle vurdere forebyggelse af aterotrombotiske hændelser, hvor ticagrelor blev givet i 2 doser (enten 90 mg to gange dagligt eller 60 mg to gange dagligt) i kombination med en lav dosis ASA (75-150 mg), sammenlignet med ASA-behandling alene til patienter med tidligere MI og yderligere risikofaktorer for aterotrombose.
The PEGASUS TIMI-54 study was a 21,162 patient, event-driven, randomised, double-blind, placebo-controlled, parallel group, international multicentre study to assess the prevention of atherothrombotic events with ticagrelor given at 2 doses (either 90 mg twice daily or 60 mg twice daily) combined with low dose ASA (75-150 mg), compared to ASA therapy alone in patients with history of MI and additional risk factors for atherothrombosis.
Filmovertrukket tablet (tablet): Tabletterne er runde, bikonvekse, pink, filmovertrukne, præget med "60" over "T" på den ene side.
What Brilique looks like and contents of the pack Film-coated tablet (tablet): The tablets are round, biconvex, pink, film-coated marked with a “60” above “T” on one side.
Filmovertrukket tablet (tablet): Tabletterne er runde, bikonvekse, gule, filmovertrukne, præget med "90" over "T" på den ene side.
What Brilique looks like and contents of the pack Film-coated tablet (tablet): The tablets are round, biconvex, yellow, film-coated marked with a “90” above “T” on one side.
Patienter med øget risiko for bradykardi-hændelser (f.eks. patienter uden en pacemaker som har syg sinus-knude, 2. eller 3. grads AV-blok eller bradykardi-relateret synkope) var udelukket fra hovedstudierne, der vurderede sikkerheden og effekt af ticagrelor.
rd degree AV block or bradycardic-related syncope) have been excluded from the main studies evaluating the safety and efficacy of ticagrelor.
Perforeret enkeltdosisblister
PERFORATED UNIT DOSE BLISTER
Runde, flade, hvide til svagt lyserøde tabletter med skrå kanter, præget med "90" over "TI" på den ene side og glat på den anden.
Round, flat, bevelled edged, white to pale pink, orodispersible tablets marked with ‘90' above ‘TI' on one side and plain on the other.