natgillin/translations-raw huggingface dataset:
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.
COX-2 je tista izooblika encima, ki jo dokazano inducirajo provnetni dražljaji in naj bi bila predvsem odgovorna za sintezo prostanoidnih mediatorjev bolecin, vnetja in zvišane telesne temperature.
The significantly lower incidence of this event with celecoxib was maintained with or without acetylsalicylic acid use.
Incidenca tega ucinka je bila ob celekoksibu znacilno manjša ne glede na uporabo ali neuporabo acetilsalicilne kisline.
Patients known to be CYP2C9 poor metabolisers should be treated with caution.
Bolnike, ki so slabi slabi metabolizatorji s CYP2C9, je treba zdraviti previdno.
Twenty-two percent of enrolled patients took concomitant low-dose acetylsalicylic acid (£325 mg/day),
Dvaindvajset odstotkov vkljucenih bolnikov je hkrati jemalo nizke odmerke acetilsalicilne kisline (£ 325 mg/dan), predvsem za kardiovaskularno profilakso.
Concomitant use of 200 mg single dose of celecoxib and 200 mg once daily of fluconazole, a potent CYP2C9 inhibitor, resulted in a mean increase in celecoxib Cmax of 60% and in AUC of 130%.
Socasna uporaba enkratnega odmerka 200 mg celekoksiba in 200 mg flukonazola (mocnega zaviralca CYP2C9) enkrat na dan je povzrocila povprecno povecanje Cmax celekoksiba za 60 % in njegove AUC za 130 %.
Breast feeding (See 4.6 and 5.3).
Dojenje (glejte poglavji 4.6 in 5.3).
4.6 Pregnancy and lactation
4.6 Nosecnost in dojenje
As the cardiovascular risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
Ker se tveganje za srcnožilna obolenja pri višjih odmerkih celekoksiba in daljši izpostavljenosti zdravilu lahko poveca, naj bo trajanje zdravljenja cim krajše, dnevni odmerek pa najmanjši, ki je še ucinkovit.
Experience in such patients is limited to cirrhotic patients (See 4.3, 4.4 and 5.2).
Izkušnje s takšnimi bolniki so omejene predvsem na tiste s cirozo (glejte poglavja 4.3, 4.4 in 5.2).
Conventional embryo-fetal toxicity studies resulted in dose dependent occurrences of diaphragmatic hernia in rat fetuses and of cardiovascular malformations in rabbit fetuses at systemic exposures to free drug approximately 5X (rat) and 3X (rabbit) higher than those achieved at the maximum recommended daily human dose (400 mg).
Konvencionalne raziskave toksicnosti zdravila za zarodek in plod so pokazale od odmerka odvisno pojavnost hernije diafragme pri podganjih plodih in od odmerka odvisno pojavnost srcnožilnih malformacij pri kuncjih plodih pri sistemski izpostavljenosti prostemu zdravilu, ki je bila približno 5x (podgane) oz. 3x (kunci) višja kot jo dosežemo z maksimalnim priporocenim dnevnim odmerkom za ljudi (400 mg).
Immune system disorders: Very rare: serious allergic reactions, anaphylactic shock
Bolezni imunskega sistema Zelo redki: resna alergijska reakcija, anafilakticni šok
Celecoxib is metabolised in the liver by hydroxylation, oxidation and some glucuronidation.
Celekoksib se presnovi v jetrih s hidroksilacijo, oksidacijo in deloma z glukuronidacijo.
In patients on concurrent therapy with warfarin, serious bleeding events have occurred.
Pri bolnikih, socasno zdravljenih z varfarinom, so se pojavile resne krvavitve.
However, adequate monitoring for methotrexate-related toxicity should be considered when combining these two drugs.
Vendar je med socasno uporabo teh dveh zdravil priporocljivo ustrezno spremljati toksicne ucinke metotreksata.
For all strokes, there was no increased event rate with celecoxib compared with placebo.
Za vse kapi skupaj se delež incidentov pri celekoksibu ni razlikoval od placeba.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [Item to be completed by the Marketing Authorisation Holder once the Marketing Authorisation has been granted or renewed.]
DATUM DOVOLJENJA ZA PROMET Tocka bo dopolnjena s strani imetnika dovoljenja za promet, po izdaji ali podaljšanju odlocbe.
The incidence of clinically significant decreases in haemoglobin (>2 g/dL), confirmed by repeat testing, was significantly lower in patients on celecoxib compared to the NSAID group, relative risk 0.29, 95% CI 0.17- 0.48.
Incidenca klinicno pomembnega znižanja hemoglobina (> 2 g/dl), potrjenega s ponovnim testiranjem, je bila znacilno manjša med bolniki, ki so dobivali celekoksib, kot med bolniki, ki so dobivali nesteroidne antirevmatike (relativno tveganje 0,29, 95 % IZ 0,17-0,48).
Pharmacokinetic interactions
Farmakokineticno medsebojno delovanje
Cardiac disorders Uncommon: myocardial infarction*, heart failure, palpitations
Srcne bolezni Obcasni: miokardni infarkt*, srcno popušcanje, palpitacije
§ Further to the assessment of: - the new data provided on rofecoxib by the APPROVe clinical study, which revealed a risk of thrombotic CV events, - the data on celecoxib presented in the APC study, which suggested a dose-related increased risk of serious CV events, - the data on valdecoxib and parecoxib presented in the CABG (Coronary Artery Bypass Graft) and in the CABG II studies, which showed a higher rate of serious CV thromboembolic events in the parecoxib/valdecoxib treatment arm compared to the group of patients receiving placebo, - the data on etoricoxib in the EDGE study and pooled analyses of other clinical trials, which suggested an association with a higher thrombotic risk than naproxen, - the data on lumiracoxib in the Target study, which suggested a small increase in thrombotic events (especially myocardial infarction) versus naproxen, all available data show an increased risk of CV adverse reactions for Cox-2 inhibitors as a class and agreed that there is an association between duration and dose of intake and the probability of suffering a CV reaction.
§ po vrednotenju: - novih podatkov, ki jih je za rofekoksib prispevala klinicna raziskava APPROVe in ki kažejo tveganje za tromboticne kardiovaskularne dogodke, - podatkov za celekoksib iz raziskave APC, ki so nakazali povecanje tveganja hudih kardiovaskularnih dogodkov, ki so odvisni od odmerka, - podatkov za valdekoksib in parekoksib iz raziskav CABG (Coronary Artery Bypass Graft) in CABG II, ki kažejo višjo stopnjo hudih kardiovaskularnih tromboembolijskih dogodkov v skupinah bolnikov, ki so se zdravili s parekoksibom/valdekoksibom, v primerjavi s skupino bolnikov, ki je prejemala placebo, - podatkov za etorikoksib iz raziskave EDGE ter analiz združenih podatkov iz drugih klinicnih preizkušanj, ki nakazujejo povezavo z vecjim tveganjem za tromboticne dogodke v primerjavi z naproksenom, - podatkov za lumirakoksib iz raziskave Target, ki nakazujejo majhno povecanje tromboticnih dogodkov (zlasti miokardnega infarkta) v primerjavi z naproksenom,
Diaphragmatic hernia was also seen in a peri-post natal toxicity study in rats, which included exposure during the organogenetic period.
Hernijo diafragme so ugotavljali tudi pri raziskavah peri- in postnatalne toksicnosti zdravila pri podganah, v katerih so živali prejemale zdravilo tudi v casu organogeneze.
It was also evaluated for treatment of the inflammation and pain of RA in approximately 2100 patients in placebo and active controlled trials of up to 24 weeks duration.
Ocenili so ga tudi za zdravljenje vnetja in bolecin pri revmatoidnem artritisu, in sicer pri približno 2.100 bolnikih v preskušanjih, kontroliranih s placebom ali aktivno ucinkovino, ki so trajala do 24 tednov.
Celecoxib is mainly eliminated by metabolism.
Celekoksib se eliminira predvsem s presnovo.
The plasma concentrations of drugs that are substrates of this enzyme may be increased when celecoxib is used concomitantly.
Plazemska koncentracija zdravil, ki so substrati tega encima, se lahko med socasno uporabo s celekoksibom poveca.
The plasma concentration of celecoxib is approximately 100% increased in elderly women (>65 years).
Pri starejših ženskah (> 65 let) je koncentracija celekoksiba v plazmi za približno 100 % višja.
Celecoxib at daily doses of 200 mg - 400 mg provided pain relief within 24 hours of dosing.
Celekoksib v dnevnih odmerkih od 200 mg do 400 mg je bolecine olajšal v 24 urah po uporabi.
Therefore, patients on lithium treatment should be closely monitored when celecoxib is introduced or withdrawn.
Bolnike, ki dobivajo litij, je zato treba po uvedbi ali opustitvi celekoksiba natancno spremljati.
For the combined endpoint, complicated and symptomatic ulcers, the incidence was significantly lower in the celecoxib group compared to the NSAID group, relative risk 0.66, 95% CI 0.45-0.97 but not between celecoxib and diclofenac.
Glede kombinirane koncne tocke, ki so jo predstavljali zapleteni in simptomatski ulkusi, je bila incidenca v skupini s celekoksibom znacilno manjša kot v skupini z nesteroidnimi antirevmatiki (relativno tveganje 0,66, 95 % IZ 0,45-0,97), ne pa med celekoksibom in diklofenakom.
In a prospective long-term safety outcome study (6 to 15 month duration, CLASS study), 5,800 OA and 2,200 RA patients received celecoxib 400 mg BID (4-fold and 2-fold the recommended OA and RA doses, respectively), ibuprofen 800 mg TID or diclofenac 75 mg BID (both at therapeutic doses).
V prospektivni dolgorocni študiji varnosti (trajanje od 6 do 15 mesecev, študija CLASS) je 5.800 bolnikov z osteoartritisom in 2.200 bolnikov z revmatoidnim artritisom dobivalo 400 mg celekoksiba dvakrat na dan (4-kratni priporoceni odmerek za osteoartritis oz. 2-kratni priporoceni odmerek za revmatoidni artritis), 800 mg ibuprofena trikrat na dan ali 75 mg diklofenaka dvakrat na dan (oboje v obmocju terapevtskih odmerkov).
Celecoxib inhibits CYP2D6.
Celekoksib zavira CYP2D6.
- Strengthening of a warning to highlight that fatal serious skin reactions have now occurred with celecoxib.
- okrepljeno je opozorilo, ki poudarja, da so se pri uporabi celekoksiba pojavile hude kožne reakcije s smrtnim izidom.
Celecoxib was excreted in rat milk.
Ugotavljali so, da se celekoksib izloca v mleko pri podganah.
The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (4.3, 4.4, 4.8 and 5.1).
Obcasno je treba ponovno oceniti potrebo bolnika po lajšanju simptomov in njegov odziv na zdravljenje, še posebej to velja pri bolnikih z osteoartrozo (glejte poglavja 4.3, 4.4, 4.8. in 5.1.
Pharmacological activity resides in the parent drug.
Farmakološko aktivno je maticno zdravilo.
- Addition of a warning for prescribers to exercise caution when prescribing NSAIDs, including celecoxib, in combination with ACE inhibitors or angiotensin II receptor antagonists.
- dodano je opozorilo za predpisovalce zdravila, naj bodo previdni pri predpisovanju neselektivnih nesteroidnih protivnetnih zdravil (non-steroidal anti-inflammatory drugs, NSAIDs), vkljucno s celekoksibom, v kombinaciji z zaviralci ACE ali antagonisti receptorjev angiotenzina II.
Celecoxib is an inhibitor of CYP2D6.
Celekoksib je zaviralec CYP2D6.
Uncommon: blurred vision, hypertonia, paraesthesia Rare: ataxia, taste alteration
Obcasni: zamegljen vid, hipertonija, parestezije Redki: ataksija, spremembe okusa
Rheumatoid arthritis: The initial recommended daily dose is 200 mg taken in two divided doses.
Revmatoidni artritis: Priporoceni zacetni dnevni odmerek je 200 mg, ki naj ga bolnik vzame v dveh deljenih odmerkih.
Plasma concentrations of celecoxib are probably markedly increased in such patients.
Pri takšnih bolnikih je koncentracija celekoksiba v plazmi verjetno izrazito zvišana.
Celecoxib does not affect the pharmacokinetics of tolbutamide (CYP2C9 substrate), or glibenclamide to a clinically relevant extent.
Celekoksib nima klinicno pomembnega vpliva na farmakokinetiko tolbutamida (substrat CYP2C9) ali glibenklamida.
In the same studies, the excess rate for clearly identified ischaemic stroke for the 400 mg daily dose (not including events that were haemorrhagic or of unknown aetiology) was 0.5 event per 1000 over 3 years (Rare).
V isti študiji je bil presežni delež jasno identificirane ishemicne možganske kapi pri odmerku 400 mg na dan (izkljucujoc incidente, ki so bili hemoragicni ali neznane etiologije) 0,5 incidentov na 1000 v 3 letih (redko).
In preliminary data from two studies in patients with colorectal polyps treated with celecoxib 400 mg daily (see Section 5.1) the excess rate over placebo of myocardial infarction over 3 years was 7 events per 1000 patients (Uncommon).
Po preliminarnih podatkih ene od dveh študij pri bolnikih s kolorektalnimi polipi, zdravljenih s 400 mg celekoksiba na dan (glejte poglavje 5.1), je bil presežni delež miokardnih infarktov v primerjavi s placebom v 3 letih 7 incidentov na 1000 bolnikov (obcasno).
Capsules 100 mg contain lactose monohydrate, sodium lauryl sulphate, povidone K30, croscarmellose sodium and magnesium stearate.
Kapsule vsebujejo laktozo monohidrat, natrijev lavrilsulfat, povidon K30, natrijev karmelozat, premreženi in magnezijev stearat.
Five randomised double-blind controlled studies have been conducted including scheduled upper gastrointestinal endoscopy in approximately 4500 patients free from initial ulceration (celecoxib doses from 50 mg-400 mg BID).
Izvedenih je bilo pet randomiziranih, dvojno slepih kontroliranih študij, ki so vkljucevale elektivno endoskopijo zgornjih prebavil, pri približno 4.500 bolnikih, ki uvodoma niso imeli ulkusov (odmerki celekoksiba od 50 mg do 400 mg dvakrat na dan).
Since celecoxib is predominantly metabolised by CYP2C9 it should be used at half the recommended dose in patients receiving fluconazole.
Celekoksib se pretežno presnavlja s CYP2C9, zato je treba pri bolnikih, ki dobivajo flukonazol, uporabiti le polovicen priporoceni odmerek celekoksiba.
Celecoxib, as with other drugs inhibiting prostaglandin synthesis, may cause uterine inertia and premature closure of the ductus arteriosus during the last trimester.
Tako kot druga zdravila, ki zavirajo sintezo prostaglandinov, lahko tudi celekoksib v zadnjem trimesecju povzroci inertnost maternice in prezgodnje zaprtje arterioznega duktusa.
Very rare: gastrointestinal haemorrhage, acute pancreatitis, colitis/colitis aggravated.
Zelo redki: gastrointestinalna krvavitev, akutni pankreatitis, kolitis/poslabšanje kolitisa
4.2 Posology and method of administration
4.2 Odmerjanje in nacin uporabe
Celecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Celekoksib moramo ukiniti ob prvem pojavu kožnega izpušcaja, lezij na sluznicah ali kakršnegakoli drugega znaka preobcutljivosti.
In healthy subjects, co-administration of celecoxib 200 mg twice daily with 450 mg twice daily of lithium resulted in a mean increase in Cmax of 16% and in AUC of 18% of lithium.
Pri zdravih preiskovancih je socasna uporaba 200 mg celekoksiba dvakrat na dan in 450 mg litija dvakrat na dan povzrocila povprecno zvecanje Cmax litija za 16 % in njegove AUC za 18 %.
Osteoarthritis: The usual recommended daily dose is 200 mg taken once daily or in two divided doses.
Osteoartroza: Obicajni priporoceni dnevni odmerek je 200 mg, ki naj ga bolnik vzame naenkrat ali v dveh deljenih odmerkih.
In twelve week endoscopy studies celecoxib (100-800 mg per day) was associated with a significantly lower risk of gastroduodenal ulcers compared with naproxen (1000 mg per day) and ibuprofen (2400 mg per day).
V dvanajsttedenskih endoskopskih študijah je bilo tveganje za ulkuse na želodcu in dvanajstniku s celekoksibom (100 do 800 mg na dan) znacilno manjše kot z naproksenom (1.000 mg na dan) oz. ibuprofenom (2.400 mg na dan).
In April 2005, the FDA (Food and Drug Administration) and the EMEA requested that Pfizer voluntarily withdraw Bextra (valdecoxib) from the market and Pfizer agreed to suspend sale and marketing of Bextra worldwide pending further discussions on the unfavorable risk versus benefit due to data on serious skin reactions.
Dne 7. aprila 2005 sta FDA (Food and Drug Administration) in EMEA zaradi podatkov o hudih kožnih reakcijah zahtevali, da podjetje Pfizer prostovoljno umakne zdravilo Bextra (valdekoksib) iz prometa.
General disorders and administration site conditions Common: peripheral oedema/ fluid retention
Splošne težave in spremembe na mestu aplikacije Pogosti: periferni edemi/zastajanje tekocine
Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
Bolniki, ki so imeli v preteklosti astmo, akutni rinitis, nosne polipe, angionevrotski edem, urtikarijo ali katero drugo alergicno reakcijo po jemanju acetilsalicilne kisline ali nesteroidnih antirevmatikov.
Clinical 1
Klinicni vidik 1
A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs. NSAIDs + acetylsalicylic acid has not been demonstrated in longterm clinical trials (see 5.1).
Glede GI varnosti pri primerjavi selektivnih zaviralcev COX-2 in acetilsalicilne kisline ter NSAID-ov in acetilsalicilne kisline po izvedenih dolgotrajnih klinicnih študijah ni bilo nobene bistvene razlike (glejte poglavje 5.1).
Side-effects listed have a rate equal or greater than placebo, and the discontinuation rate due to side effects was 7.1% in patients receiving celecoxib and 6.1% in patients receiving placebo.
Delež prekinitev zaradi neželenih ucinkov je bil 7,1 % pri bolnikih, ki so dobivali celekoksib, in 6,1 % pri bolnikih, ki so dobivali placebo.
The relative risk (RR) for the composite endpoint (cardiovascular death, MI or stroke) was 3.4 (95% CI 1.4 - 8.5) for the higher dose and 2.5 (95% CI 1.0 - 6.4) for the lower dose of celecoxib, compared to placebo.
Relativno tveganje (RT) za sestavljen opazovani dogodek (srcnožilna smrt, MI ali možganska kap) je bilo pri višjem odmerku celekoksiba v primerjavi s placebom 3,4 (95 % IZ 1,4-8,5) in pri manjšem odmerku celekoksiba 2,5 (95 % IZ 1,0-6,4).
Preliminary data from the other two long-term studies did not show a significantly increased cardiovascular risk with celecoxib 200mg BID and 400mg QD compared to placebo.
Preliminarni podatki iz drugih dveh dolgotrajnih študij v primerjavi s placebom niso pokazali znatnega porasta srcnožilnega tveganja pri uporabi celekoksiba v odmerku 200 mg dvakrat na dan in 400 mg QD.
Very rare: aggravated epilepsy, meningitis aseptic, ageusia, anosmia
Zelo redki: poslabšanje epilepsije, asepticni meningitis, agevzija, anozmija
There is further increase in the risk of gastrointestinal adverse effects for celecoxib (gastrointestinal ulceration or other gastrointestinal complications), when celecoxib is taken concomitantly with acetylsalicylic acid (even at low doses).
Nadalje obstaja vecje tveganje za neželene ucinke v prebavilih (razjeda v prebavilih ali drugi zapleti prebavil), kadar se celekoksib uporablja socasno z acetilsalicilno kislino (tudi ce so njeni odmerki majhni).
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 acetylsalicylic acid concomitantly or patients with a prior history of gastrointestinal disease, such as ulceration and GI bleeding.
Previdnost je potrebna pri zdravljenju bolnikov, ki jih med uporabo nesteroidnih antirevmatikov najbolj ogrožajo zapleti na prebavilih: starejših bolnikov, bolnikov, ki socasno uporabljajo kakšen drug nesteroiden antirevmatik ali acetilsalicilno kislino, in bolnikov z anamnezo bolezni prebavil, npr. ulkusov ali krvavitev.
During celecoxib treatment, the plasma concentrations of the CYP2D6 substrate dextromethorphan were increased by 136%.
Plazemska koncentracija dekstrometorfana, substrata CYP2D6, se je med zdravljenjem s celekoksibom povecala za okrog 136 %.
Reproductive system and breast disorders Very rare: menstrual disorder NOS
Motnje reprodukcije in dojk Zelo redki: menstruacijska motnja, NDO
Common: dizziness
Pogosti: nespecnost
Greece
Grcija
Those patients on celecoxib and concomitant lowdose acetylsalicylic acid experienced 4 fold higher rates of complicated ulcers as compared to those on celecoxib alone.
Med bolniki, ki so hkrati dobivali celekoksib in nizke odmerke acetilsalicilne kisline, je bil delež zapletenih ulkusov 4-krat vecji kot pri uporabnikih celekoksiba samega.
Compromised renal or hepatic function and especially cardiac dysfunction are more likely in the elderly and therefore medically appropriate supervision should be maintained.
Poslabšanje delovanja ledvic ali jeter, še posebej pa moteno delovanje srca so verjetnejši pri starejših bolnikih.
Metabolism and nutrition disorders Uncommon: hyperkalaemia
Presnovne in prehranske motnje Obcasni: hiperkaliemija
In two of the 12-week studies the percentage of patients with endoscopic gastroduodenal ulceration were not significantly different between placebo and celecoxib 200 mg BID and 400 mg BID.
V dveh od teh 12-tedenskih študij se odstotek bolnikov z endoskopsko ugotovljenim ulkusom na želodcu ali dvanajstniku ni znacilno razlikoval med placebom in celekoksibom 200 mg dvakrat na dan oz. 400 mg dvakrat na dan.
Patients with a history of sulphonamide allergy or any drug allergy may be at greater risk of serious skin reactions or hypersensitivity reactions (see 4.3).
Resne kožne reakcije ali preobcutljivostne reakcije lahko bolj ogrožajo bolnike z anamnezo alergije na sulfonamide ali alergije na kakršnakoli zdravila (glejte poglavje 4.3).
COX-2 selective inhibitors are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thrombo-embolic diseases because of their lack of antiplatelet effects.
Selektivni zaviralci COX-2 ne vplivajo na antitrombocitno delovanje, zato niso nadomestilo za acetilsalicilno kislino v profilaksi kardiovaskularnih trombembolicnih bolezni.
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use ofcelecoxib (see 4.8).
Z uporabo celekoksiba so bile povezane resne kožne reakcije, nekatere s smrtnim izidom, med njimi eksfoliacijski dermatitis, Stevens-Johnsonov sindrom in toksicna epidermalna nekroliza (glejte poglavje 4.8).
5.2 Pharmacokinetic properties
5.2 Farmakokineticne lastnosti
In a peri-post natal study in rats, pup toxicity was observed.
V neki raziskavi peri- in postnatalne toksicnosti zdravila pri podganah so opažali toksicne ucinke pri mladicih.
No statistically significant inhibition of COX-1 (assessed as ex vivo inhibition of thromboxane B2 [TxB2] formation) was observed in this dose range in healthy volunteers.
V tem obmocju odmerkov pri zdravih prostovoljcih niso ugotovili statisticno znacilnega zavrtja COX-1 (ocenjevanega z zavrtjem tvorbe tromboksana B2 [TxB2] ex vivo).
*In a pooled analysis of 20 placebo-controlled studies with duration greater than 2 weeks up to 1 year in patients with OA and RA, the excess rate of myocardial infarction in patients treated with celecoxib 200 or 400 mg daily over placebo was 0.7 events per 1000 patients (Rare) and there was no excess of strokes.
V kumulativni analizi 20 s placebom kontroliranih študij pri bolnikih z OA in RA, ki so trajale vec kot 2 tedna in do 1 leta, je bil presežni delež miokardnega infarkta pri bolnikih, ki so dobivali 200 mg ali 400 mg celekoksiba na dan, v primerjavi s placebom, 0,7 incidenta na 1000 bolnikov (redko).
Clinical 5
Klinicni vidik 5
The following events have been reported in patients receiving celecoxib in 12 placebo and/or active controlled trials.
Pri bolnikih, ki so celekoksib dobivali v 12 preskušanjih, kontroliranih s placebom in/ali aktivno ucinkovino, so porocali o naslednjih ucinkih.
Celecoxib was evaluated for the treatment of the inflammation and pain of OA of the knee and hip in approximately 4200 patients in placebo and active controlled trials of up to 12 weeks duration.
Za zdravljenje vnetja in bolecin pri osteoartritisu kolena in kolka so celekoksib ocenili pri približno 4.200 bolnikih v preskušanjih, kontroliranih s placebom ali aktivno ucinkovino, ki so trajala do 12 tednov.
Rare: ischaemic stroke* Very rare: vasculitis.
Obcasni: hipertenzija, poslabšanje hipertenzije Redko: ishemicna kap* Zelo redki: vaskulitis