FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients who have experienced asthma, acute rhinitis, nasal polyps, angioedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or NSAIDs.
Bulgarian: som tidligere har hatt astma, akutt rhinitt, nasale polypper, angioneurotisk ødem, urticaria eller andre allergilignende reaksjoner ved bruk av acetylsalisylsyre eller NSAIDs. Pasienter med aktivt peptisk sår eller gastrointestinal blødning.
English: Based on in vitro studies, interactions involving plasma protein binding are not expected to have any clinically relevant effects on lumiracoxib or co-administered drugs.
Bulgarian: som involverer plasmaproteiner forventes ikke å ha en klinisk relevant effekt på lumirakoksib eller andre legemidler
English: Uncommon: alanine aminotransferase increased, aspartate aminotransferase increased, blood creatinine increased, blood urea increased, gamma-glutamyltransferase increased, weight increased.
Bulgarian: Mindre vanlige: forhøyet ALAT, forhøyet ASAT, forhøyet blodkreatinin, forhøyet blodurea, forhøyet gammaglutamyltransferase, vektøkning
English: In a long-term controlled study with lumiracoxib 400 mg daily, rare cases of hepatitis have been reported (see section 4.8).
Bulgarian: i en kontrollert langtidsstudie med lumirakoksib 400 mg daglig (se pkt.
English: Food had no significant effect on either Cmax or AUC of lumiracoxib when either 200 mg or 400 mg film-coated tablets of {Invented Name} were taken with a high-fat meal.
Bulgarian: signifikant effekt på Cmax eller på AUC til lumirakoksib ved inntak av 200 mg eller 400 mg {Legemidlets navn} filmdrasjerte tabletter
English: The absolute bioavailability of lumiracoxib is approximately 74%.
Bulgarian: Absolutt biotilgjengelighet av lumirakoksib er ca.
English: Other NSAIDs: Lumiracoxib can be used with low-dose aspirin.
Bulgarian: Andre NSAIDs: Lumirakoksib kan brukes i kombinasjon med lavdose acetylsalisylsyre.
English: Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, coxibs, ATC code: M01 AH 06
Bulgarian: Farmakoterapeutisk gruppe: Antiinflammatoriske og antirheumatiske midler, ikke-steroider, koksiber.
English: Cellulose microcrystalline, croscarmellose sodium, povidone, magnesium stearate
Bulgarian: Kjerne: Mikrokrystallinsk cellulose, krysskarmelosenatrium, povidon, magnesiumstearat.
English: Relief of acute pain due to orthopaedic surgery: the maximum treatment duration in clinical studies was 5 days.
Bulgarian: smerte ved ortopedisk kirurgi: Maksimal behandlingsvarighet i kliniske studier var 5 dager.
English: For diastolic blood pressure, mean change from baseline were0.1 mmHg for lumiracoxib and +0.5 mmHg for NSAIDs (p<0.0001).
Bulgarian: Gjennomsnittlig endring i diastolisk blodtrykk fra behandlingsstart var -0,1 mmHg for lumirakoksib og +0,5 mmHg for NSAIDs (p<0,0001).
English: Safety The Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET)
Bulgarian: ”The Therapeutic Arthritis Research and Gastrointestinal Event Trial” (TARGET) TARGET, er en 12 måneders, dobbeltblind, fase III
English: Efficacy
Bulgarian: Effekt
English: Hepatobiliary disorders Rare: cholecystitis, cholelithiasis, hepatitis
Bulgarian: Sykdommer i lever og galleveier: Sjeldne: kolecystitt, kolelitiasis, hepatitt
English: Cellulose microcrystalline, croscarmellose sodium, lactose monohydrate, povidone, titanium dioxide, magnesium stearate
Bulgarian: Kjerne: Mikrokrystallinsk cellulose, krysskarmelosenatrium, laktosemonohydrat, povidon, titandioksid, magnesiumstearat.
English: Uncommon: dyspnoea, epistaxis, rhinitis, sinus congestion, asthma
Bulgarian: Mindre vanlige: dyspné, epistakse, rhinitt, sinusobstruksjon, astma
English: Therefore, lumiracoxib should be used with caution in patients with history of cardiac failure, left ventricular dysfunction or hypertension, and in patients with pre-existing oedema from any other reason.
Bulgarian: Lumirakoksib bør derfor brukes med forsiktighet hos pasienter med tidligere hjertesvikt, venstre ventrikkeldysfunksjon eller hypertensjon, og hos pasienter
English: No dose adjustment is necessary in patients known to be CYP2C9 poor metabolisers.
Bulgarian: ikke nødvendig hos pasienter med nedsatt CYP2C9-metabolisme.
English: Caution is advised with treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs: the elderly, patients using any other NSAID or ASA concomitantly, or patients with a prior history of gastrointestinal disease, such as ulceration and GI bleeding.
Bulgarian: Forsiktighet anbefales ved behandling av pasienter med økt risiko for å utvikle gastrointestinale komplikasjoner med NSAIDs; eldre, pasienter
English: Monitoring of renal function in such patients should be considered.
Bulgarian: Det bør derfor vurderes om nyrefunksjonen hos disse pasientene
English: Compared to healthy subjects, exposure to lumiracoxib was not changed in patients with moderate hepatic impairment (Child-Pugh score 7-8).
Bulgarian: Eksponering av lumirakoksib var ikke forandret hos pasienter med moderat nedsatt leverfunksjon (Child-Pugh 7-8) sammenlignet med friske personer.
English: If signs of hepatic insufficiency occur, or if abnormal liver function tests (ALT or AST>3xULN) persist, lumiracoxib should be discontinued.
Bulgarian: som har avgitt en unormal leverfunksjonsprøve, bør overvåkes. Dersom tegn på leverinsuffisiens forekommer, eller det oppdages vedvarende unormale leverfunksjonsverdier (ALAT eller ASAT >3xULN), bør behandlingen med lumirakoksib avbrytes.
English: COX-2 is the isoform of the enzyme that has been shown to be induced by proinflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Bulgarian: som er vist å bli indusert av pro-inflammatoriske stimuli og antas primært å være ansvarlig for syntesen av prostanoidmediatorer for smerte, inflammasjon og feber. COX-2 er også involvert
English: Relief of acute pain due to dental surgery: the maximum treatment duration in clinical studies was 24 hours.
Bulgarian: smerte ved tannkirurgi: Maksimal behandlingsvarighet i kliniske studier var 24 timer.
English: Infections
Bulgarian: Infeksiøse sykdommer
English: 200 mg film-coated tablets: Ovaloid, red, tablets with “NVR” debossed on one side and “OC” on the other side.
Bulgarian: 200 mg filmdrasjerte tabletter: Ovale, røde, tabletter preget med ”NVR” på den ene siden og ”OC” på den andre siden.
English: 400 mg film-coated tablets: Ovaloid, red, tablets with “NVR” debossed on one side and “OD” on the other side.
Bulgarian: 400 mg filmdrasjerte tabletter: Ovale, røde, tabletter preget med ”NVR” på den ene siden og ”OD” på den andre siden.
English: [C]-labeled lumiracoxib in a rat model of inflammation, the ratio of radioactivity detected at the site of inflammation versus that detected in the blood was 2:1, and was 8:1 four hours post dose.
Bulgarian: [C]-merket lumirakoksib 2:1. Fire timer etter dosering var forholdet 8:1.
English: Lumiracoxib at 800 mg daily did not lead to clinically meaningful inhibition of gastric prostaglandin synthesis and had no effect on platelet function.
Bulgarian: Lumirakoksib 800 mg daglig ga ikke klinisk signifikant hemming av prostaglandinsyntese i magen og hadde
English: 100 mg film-coated tablets: Ovaloid, red, tablets with “NVR” debossed on one side and “OB” on the other side.
Bulgarian: 100 mg filmdrasjerte tabletter: Ovale, røde, tabletter preget med ”NVR” på den ene siden og ”OB” på den andre siden.
English: These beneficial effects were maintained for up to 52 weeks.
Bulgarian: til 52 uker.
English: The number of discontinuations due to hypertension-related events was also not significantly different between lumiracoxib (37) and NSAIDs (52).
Bulgarian: ikke signifikant forskjellig for lumirakoksib (37) og NSAIDs (52).
English: The following rare serious undesirable effects have been reported in association with the use of NSAIDs and cannot be ruled out for lumiracoxib: nephrotoxicity including interstitial nephritis and nephrotic syndrome and renal failure; hepatotoxicity including hepatic failure and jaundice; cutaneomucosal adverse effects and severe skin reactions.
Bulgarian: Nefrotoksisitet, inkludert interstitiell nefritt, nefrotisk syndrom og nyresvikt; hepatotoksisitet, inkludert leversvikt og gulsott; kutanmukosale reaksjoner og alvorlige hudreaksjoner.
English: Respiratory disorders
Bulgarian: Sykdommer i respirasjonsorganer:
English: Oral anticoagulants: In a drug-drug interaction study in healthy subjects stabilised on warfarin therapy, the administration of lumiracoxib 400 mg once daily for five days was associated with an approximate 15% increase in prothrombin time.
Bulgarian: som var stabilisert på warfarinbehandling, ga administrasjon av lumirakoksib 400 mg daglig i 5 dager ca.
English: Dosage adjustment in the elderly is not necessary.
Bulgarian: Dosejustering hos eldre er
English: Film-coated tablets 200 mg:
Bulgarian: Filmdrasjerte tabletter 200 mg:
English: Marked elevations (>8xULN) have been observed in 0.3% with 100 mg once or twice daily and 0.6% of patients at 200 mg once daily.
Bulgarian: Betydelig økning (>8xULN) er observert hos 0,3% av pasientene behandlet med 100 mg en eller
English: There was no indication of genotoxic potential in three in vivo rat studies (micronucleus tests in bone marrow and liver and liver comet assay).
Bulgarian: i tre in vivo rottestudier (mikrokjernetest i benmarg og lever, leverkometassay).
English: Each 400 mg film-coated tablet contains 400 mg lumiracoxib.
Bulgarian: Hver 400 mg filmdrasjerte tablett inneholder 400 mg lumirakoksib.
English: Film-coated tablets 400 mg:
Bulgarian: Filmdrasjerte tabletter 400 mg:
English: Characteristics in patients
Bulgarian: Pasientfaktorer
English: In patients with osteoarthritis, lumiracoxib doses up to 200 mg once daily provided significant improvements in pain, stiffness, function, and patient assessments of disease status.
Bulgarian: til 200 mg en gang daglig ga signifikant bedring av smerte, stivhet, fysisk funksjon og egen vurdering av sykdomsstatus hos pasienter med artrose.
English: Each 200 mg film-coated tablet contains 200 mg lumiracoxib.
Bulgarian: Hver 200 mg filmdrasjerte tablett inneholder 200 mg lumirakoksib.
English: However care should be exercised when lumiracoxib is co-administered with substrates of CYP2C9 that have very narrow therapeutic index, such as phenytoin and warfarin.
Bulgarian: samtidig med CYP2C9-substrater med smalt terapeutisk vindu, f.eks. fenytoin og warfarin.
English: At 15 minutes post 400 mg dose, the plasma concentration reached 0.6 µg/ml, which is sufficiently high to achieve over 90% inhibition of COX-2.
Bulgarian: Plasmakonsentrasjon 15 minutter etter inntak av 400 mg var 0,6 mikrog/ml, som er
English: Film-coated tablets 100 mg:
Bulgarian: Filmdrasjerte tabletter 100 mg:
English: Patients at greatest risk of this response are those with pre-existing renal dysfunction, uncompensated heart failure, or cirrhosis and those receiving diuretics or ACE inhibitors.
Bulgarian: som tidligere har hatt nedsatt nyrefunksjon, ukompensert hjertesvikt eller cirrhose, samt de som får diuretika eller ACE-hemmere er spesielt utsatt.
English: Lumiracoxib does not accumulate in plasma under once or twice daily administration and steady state is achieved on the first day of administration with no increase in Cmax or AUC after extended dosing.
Bulgarian: Likevekt inntrer første behandlingsdag uten økning i Cmax eller AUC etter ytterligere inntak av lumirakoksib.
English: Third trimester of pregnancy and breast feeding (see section 4.6 and 5.3).
Bulgarian: Graviditet i tredje trimester og amming (se pkt.
English: Musculoskeletal disorders Uncommon: joint swelling, muscle cramps, arthralgia
Bulgarian: Sykdommer i muskler og skjelett: Mindre vanlige: hevelser i ledd, muskelkramper, artralgi
English: Methotrexate: Co-administration of lumiracoxib at doses of 400 mg once daily had no clinically significant effects on the plasma pharmacokinetics, plasma protein binding or urinary excretion of methotrexate and of the 7-hydroxy methotrexate metabolite.
Bulgarian: ingen klinisk signifikant effekt på plasmafarmakokinetikk, plasmaproteinbinding eller urinutskillelse av metotreksat og metabolitten 7-hydroksymetotreksat.
English: Each 100 mg film-coated tablet contains 100 mg lumiracoxib.
Bulgarian: Hver 100 mg filmdrasjerte tablett inneholder 100 mg lumirakoksib.
English: MARKETING AUTHORISATION NUMBER(S) PL 00101/0677
Bulgarian: MARKEDSFØRINGSTILLATELSESNUMMER (NUMRE)
English: For systolic blood pressure, mean change from baseline were +0.4 mmHg for lumiracoxib and +2.1 mmHg for NSAIDs (p<0.0001).
Bulgarian: Kardiorenale effekter i TARGET (12 måneders studie) Gjennomsnittlig endring i systolisk blodtrykk fra behandlingsstart var +0,4 mmHg for lumirakoksib og +2,1 mmHg for NSAIDs (p<0,0001).
English: Cardiovascular Effect in TARGET (12-month study) The primary cardiovascular (CV) endpoint studied was the Antiplatelet Trialists' Collaboration (APTC) endpoint: confirmed or probable myocardial infarction (clinical or silent), stroke (ischemic or haemorrhagic) and CV death.
Bulgarian: til ”The Antiplatelet Trialists´ Collaboration” (APTC): Bekreftet eller mulig hjerteinfarkt (klinisk eller stumt), slag (iskemisk eller hemoragisk)
English: In the overall population, the incidence of APTC events was 59/9117 patients (0.65%) for lumiracoxib versus 50/9127 patients (0.55%) for NSAIDs, with a HR of 1.14 [95% CI 0.781.66] p=0.5074.
Bulgarian: I den totale populasjonen var insidensen av APTC-hendelser 59/9117 pasienter (0,65%) for lumirakoksib versus 50/9127 pasienter (0,55%) for NSAIDs, med en HR på 1,14 [95% KI 0,781,66] p=0,5074.
English: Patients appear to be at highest risk for these reactions early in the course of therapy, with the onset of the reaction occurring in the majority of cases within the first month of treatment.
Bulgarian: Pasienter synes å ha høyest risiko for å oppleve disse reaksjonene
English: In single dose post-operative dental pain trials, the onset of analgesia occurred within 45 minutes and persisted for as long as 24 hours after dosing.
Bulgarian: smertelindrende effekt i løpet av 45 minutter og vedvarte
English: Ciclosporin or tacrolimus: Although this interaction has not been studied with lumiracoxib, coadministration of ciclosporin or tacrolimus and any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
Bulgarian: ikke er undersøkt for lumirakoksib, kan samtidig administrasjon av ciklosporin eller takrolimus med ethvert NSAID øke den nefrotoksiske effekten av ciklosporin eller takrolimus. Nyrefunksjonen bør monitoreres når lumirakoksib kombineres med noen av disse legemidlene.
English: Common: fatigue, oedema (e.g lower limb) Uncommon: appetite increased or decreased, chest pain, rigors, thirst Rare: anaphylaxis
Bulgarian: i underekstremitetene) Mindre vanlige: økt eller nedsatt appetitt, brystsmerte, rigor, tørste Sjeldne: anafylaktisk sjokk
English: Exforge
Bulgarian: Artrose
English: Compared to a daily dose of 200 mg, a daily dose of 400 mg of lumiracoxib is associated with a relatively higher frequency of drug-related adverse events, especially the gastrointestinal, neurological and psychiatric events.
Bulgarian: Lumirakoksib daglig dose 400 mg er forbundet med relativt høyere bivirkningsfrekvens enn daglig dose 200 mg.
English: Dialysis has no effect on the exposure of patients to lumiracoxib or its active metabolite.
Bulgarian: signifikant betydning for farmakokinetikken til lumirakoksib og de aktive metabolittene.
English: Oral contraceptives: Co-administration of lumiracoxib did not affect the steady state pharmacokinetics or the efficacy of ethinylestradiol and of levonorgestrel.
Bulgarian: ikke farmakokinetikken ved steady-state eller effekten av etinyløstradiol og levonorgestrel.
English: Renal Insufficiency:
Bulgarian: Nedsatt nyrefunksjon:
English: Renal and urinary disorders Uncommon: dysuria, urinary frequency, cystitis Rare: chromaturia, renal failure
Bulgarian: Mindre vanlige: dysuri, endret vannlatingsfrekvens, cystitt Sjeldne: kromaturi, nyresvikt
English: The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and COX-2 selective inhibitors may be of clinical significance in patients at risk of thrombo-embolic reactions.
Bulgarian: Forskjellen i effekt på plateaggregering mellom enkelte COX-1 hemmende NSAIDs og selektive COX-2-hemmere, kan være av klinisk betydning hos pasienter med risiko for tromboemboliske hendelser. Selektive COX-2-hemmere reduserer dannelsen av systemisk (og derfor muligens endotelial) prostasyklin uten å påvirke tromboksan i blodplatene.
English: In the overall population, the incidence of POBs was 29/9117 patients (0.32%) for lumiracoxib versus 83/9127 patients (0.91%) for NSAIDs, with a HR of 0.34 [95% CI 0.22-0.52] p<0.0001.
Bulgarian: I den totale populasjonen var insidensen av POBs 29/9117 pasienter (0,32%) for lumirakoksib versus 83/9127 pasienter (0,91%) for NSAIDs, med en HR på 0,34 [95% KI 0,22-0,52] p<0,0001.
English: In the low dose ASA group the incidence of POBs was 15/2167 patients (0.69%) for lumiracoxib versus 19/2159 patients (0.88%) for NSAIDs, with a HR of 0.79 [95% CI 0.401.55] (not statistically significant).
Bulgarian: som fikk lavdose acetylsalisylsyre var insidensen av POBs 15/2167 pasienter (0,69%) for lumirakoksib versus 19/2159 pasienter (0,88%) for NSAIDs, med en HR på 0,79 [95% KI 0,40-1,55] (ikke statistisk signifikant).
English: In the low-dose ASA group, the incidence of APTC events was 24/2167 patients (1.11%) for lumiracoxib versus 23/2159 patients (1.07%) for NSAIDs, with a hazard ratio (HR) of 1.04 [95% CI 0.59-1.84] p=0.8918.
Bulgarian: som fikk lavdose acetylsalisylsyre var insidensen av APTC hendelser 24/2167 pasienter (1,11%) for lumirakoksib versus 23/2159 pasienter (1,07%) for NSAIDs, med en hazard ratio (HR) på 1,04 [95% KI 0,59-1,84] p=0,8918.
English: COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.
Bulgarian: i vev rundt magesår hos mennesker, men dets relevans for sårtilheling er ikke klarlagt.
English: In clinical trials, lumiracoxib was evaluated for safety in approximately 7,000 patients, including approximately 4,000 patients with OA and 2,100 patients with RA (approximately 1,100 patients with OA or RA were treated for 6 month, and 530 patients with OA were treated for 1 year).
Bulgarian: 1,100 pasienter med artrose eller rheumatoid artritt ble behandlet i 6 måneder, og 530 pasienter med artrose ble behandlet i 1 år).
English: Compared to placebo treatment, recovery of the S-7-OH warfarin metabolite in urine was about 25% lower in subjects treated with lumiracoxib.
Bulgarian: Mengden av S-7-OH-metabolitten av warfarin som ble gjenfunnet i urin var ca.
English: Therefore anticoagulant activity should be monitored in patients taking warfarin or similar agents, particularly in the first few days after initiating or changing the dose of lumiracoxib.
Bulgarian: Dette gjelder spesielt de første dagene etter at behandling er igangsatt, eller ved endring av lumirakoksibdosen.
English: It is not known whether lumiracoxib is excreted in human milk.
Bulgarian: ikke kjent om lumirakoksib utskilles i morsmelk hos mennesker. Lumirakoksib skilles ut i melk hos rotter.
English: Haemodialysis is unlikely to be an efficient method of drug removal due to high protein binding.
Bulgarian: Hemodialyse gir sannsynligvis ikke en effektiv fjerning av legemidlet
English: Common: influenza like symptoms, respiratory tract infection (e.g bronchitis), urinary tract infection Uncommon: candidiasis, ear infection, herpes simplex, tooth infection
Bulgarian: Vanlige: influensalignende symptomer, luftveisinfeksjon (f.eks. bronkitt), urinveisinfeksjon Mindre vanlige:
English: DATE OF REVISION OF THE TEXT
Bulgarian: 10. OPPDATERINGSDATO
English: Core:
Bulgarian: Drasjering:
English: The use of lumiracoxib, as with any drug to inhibit COX-2, is not recommended in women attempting to conceive.
Bulgarian: som hemmer COX-2, anbefales ikke bruk av lumirakoksib hos kvinner
English: Of the total drug related material in plasma, unchanged lumiracoxib is the major component.
Bulgarian: I plasma utgjør uendret lumirakoksib hovedandelen av total mengde legemiddelrelatert materiale.
English: Lumiracoxib is highly bound to plasma proteins, (≥98%), and binding is independent of concentration over a range of 0.1 to 100 µg/mL.
Bulgarian: Proteinbindingen er uavhengig av konsentrasjon i området 0,1 til 100 mikrog/ml.
English: Clinical trials suggest that the selective COX-2 inhibitor class of drugs may be associated with a risk of thrombotic events (especially myocardial infarction (MI)and stroke), relative to placebo and some NSAID's.
Bulgarian: selektive COX-2-hemmere kan være assosiert med en risiko for trombotiske hendelser (spesielt hjerteinfarkt og slag)
English: In the population not using low-dose aspirin, the incidence of POBs was 14/6950 patients (0.2%) for lumiracoxib versus 64/6968 patients (0.92%) for NSAIDs, with a hazard ratio (HR) of 0.21 [95% CI 0.12-0.37] p<0.0001.
Bulgarian: I gruppen som ikke fikk lavdose acetylsalisylsyre var insidensen av POBs 14/6950 pasienter (0,2%) for lumirakoksib versus 64/6968 pasienter (0,92%) for NSAIDs, med en hazard ratio (HR) på 0,21 [95% KI 0,12-0,37] p<0,0001.
English: As with other drugs known to inhibit prostaglandin synthesis, fluid retention and oedema have been observed in patients taking lumiracoxib in clinical trials.
Bulgarian: som hemmer prostaglandinsyntesen, er væskeretensjon og ødem observert hos pasienter
English: In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal functions), the co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Bulgarian: dehydrerte pasienter eller eldre pasienter med svekket nyrefunksjon) kan samtidig administrasjon av en ACE-hemmer, en angiotensin-II-reseptorantagonist eller legemidler
English: Rare: pancytopenia, neutropenia, leucopenia
Bulgarian: Vanlige: hoste, faryngitt
English: Pregnancy
Bulgarian: Graviditet:
English: A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs. NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical trials (see section 5.1).
Bulgarian: sikkerhet mellom selektive COX-2-hemmere + acetylsalisylsyre og NSAIDs + acetylsalisylsyre er
English: PHARMACEUTICAL FORM
Bulgarian: LEGEMIDDELFORM
English: PHARMACEUTICAL PARTICULARS
Bulgarian: 5. FARMAKOLOGISKE EGENSKAPER
English: There were no significant differences between lumiracoxib and NSAIDs.
Bulgarian: signifikante forskjeller mellom lumirakoksib og NSAIDs. Hendelsesraten
English: The text was valid at that time.
Bulgarian: som ble undersøkt var endepunktet
English: In the population not using low-dose aspirin, the incidence of APTC events was 35/6950 patients (0.50%) for lumiracoxib versus 27/6968 patients (0.39%) for NSAIDs, with a HR of 1.22 [95% CI 0.74-2.02] p=0.4343.
Bulgarian: I gruppen som ikke fikk lavdose acetylsalisylsyre var insidensen av APTC-hendelser 35/6950 pasienter (0,50%) for lumirakoksib versus 27/6968 pasienter (0,39%) for NSAIDs, med en HR på 1,22 [95% KI 0,74-2,02] p=0,4343.
English: Other metabolites are not active as COX-1 or COX-2 inhibitors.
Bulgarian: som COX-1- eller COX-2-hemmere.
English: When compared separately to ibuprofen and naproxen, the HR were 0.75 [95% CI 0.20-2.79] p=0.6669 and 2.37 [95% CI 0.74-7.55] p=0.1454, respectively.
Bulgarian: Ved separate sammenligninger med ibuprofen og naproksen, var HR henholdsvis 0,75 [95% KI 0,20-2,79] p=0,6669 og 2,37 [95% KI 0,74-7,55] p=0,1454.
English: Skin and subcutaneous tissue disorders Uncommon: contusion, exanthem, pruritus, rash, urticaria Rare: angioedema
Bulgarian: Mindre vanlige: kontusjon, eksantem, pruritus, utslett, urticaria Sjeldne: angionevrotisk ødem