FrancophonIA/ELRC3.0 huggingface dataset:
English: Celecoxib can be used with low-dose acetylsalicylic acid but is not a substitute for acetylsalicylic acid for cardiovascular prophylaxis.
Lithuanian: Celekoksiba galima vartoti kartu su maža acetilsalicilo rugšties doze, bet netinka ji vartoti vietoj acetilsalicilo rugšties širdies bei kraujagysliu sistemos sutrikimu profilaktikai.
English: Celecoxib was excreted in rat milk.
Lithuanian: Celekoksibo patenka i žiurkes piena.
English: Effects of other drugs on celecoxib
Lithuanian: Kitu preparatu poveikis celekoksibui
English: However, adequate monitoring for methotrexate-related toxicity should be considered when combining these two drugs.
Lithuanian: Visgi šiuos du preparatus kartu vartojancius pacientus reikia tinkamai stebeti del galimo metotreksato toksinio poveikio.
English: 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).
Lithuanian: Pacientams, kurie buvo alergiški sulfonamidams ir kitiems vaistiniams preparatams, gresia didesne sunkiu padidejusio jautrumo reakciju rizika (žr.
English: In the latter study, at the lowest systemic exposure where this anomaly occurred in a single animal, the estimated margin relative to the maximum recommended daily human dose was 3X.
Lithuanian: Mažiausia šio tyrimo metu duota parenterine paros doze, sukelusi mineta apsigimima vienam gyvunui, buvo 3 kartus didesne už didžiausia rekomenduojama žmogui.
English: In a two-year toxicity study an increase in nonadrenal thrombosis was observed in male rat at high doses.
Lithuanian: Dvejus metus trukusiu preparato toksinio poveikio tyrimu duomenimis, žiurkiu patinams, gavusiems dideles preparato dozes, padaugejo neadrenaliniu tromboziu.
English: 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.
Lithuanian: Ivertinus jungtini galutini rodikli (mirtis nuo širdies ir kraujagysliu sistemos sutrikimu, MI ar insulto), nustatyta, kad vartojant celekoksiba santykine rizika (SR), palyginti su placebu, buvo didesne: vartojant didesne celekoksibo doze - 3,4 (95%, PI 1,4-8,5), o mažesne - 2,5 (95%, PI 1,0-6,4). Jungtinio galutinio rodiklio absoliucioji rizika, vartojant celekoksiba, atitinkamai - 3,0% (didesnei celekoksibo dozei) ir 2,2% (mažesnei celekoksibo dozei), o placeba
English: 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.
Lithuanian: balandžio 7 d. Maisto ir vaistu administracija (FDA) kartu su EMEA papraše Pfizer kompanijos savo iniciatyva išimti iš rinkos Bextra (valdekoksiba).
English: Clinical trials with celecoxib have shown renal effects similar to those observed with comparator NSAIDs.
Lithuanian: Klinikiniu tyrimu duomenimis, celekoksibo poveikis inkstams panašus i lyginamojo NVNU.
English: Celecoxib does not affect the pharmacokinetics of tolbutamide (CYP2C9 substrate), or glibenclamide to a clinically relevant extent.
Lithuanian: Celekoksibas klinikai reikšmingai neveike tolbutamido (metabolizuojamo CYP2C9) ar glibenklamido farmakokinetikos.
English: Marketing Authorisation Holder
Lithuanian: Registravimo liudijimo turetojas
English: 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).
Lithuanian: 12 savaiciu trukusiu endoskopijos tyrimu duomenimis, pacientams, vartojusiesiems celekoksiba (100-800 mg per para), skrandžio ir dvylikapirštes žarnos opu pavojus buvo reikšmingai mažesnis nei vartojusiesiems naproksena (1000 mg per para) ir ibuprofena (2400 mg per para).
English: The changes of the Product Information related to the SCAR can be summarised as follows: - Addition of a warning to report that the onset of skin reactions occur in the majority of cases within the first month of treatment.
Lithuanian: Su sunkiomis nepageidaujamomis odos reakcijomis (SCAR) susijusios Preparato informacijos pakeitimai gali buti apibendrinti taip: - pridedamas ispejimas, kad daugeliu atveju odos reakcijos prasideda per pirma gydymo menesi, - pridedamas ispejimas pacientams, kuriems anksciau yra pasireiškusi alergija bet kokiems vaistams, - sustiprinamas ispejimas, pabrežiant, kad naudojant celekoksiba yra kilusiu mirtinai pavojingu odos reakciju, - pridedamas išsamesnis pirmu požymiu apie odos reakcijas aprašymas, del kuriu gydymas turi buti nutrauktas.
English: 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).
Lithuanian: Iprastiniais preparato toksinio poveikio embrionui ir vaisiui tyrimais nustatyta, kad parenteraliai duodant žiurkems maždaug 5 kartus, o triušiams maždaug 3 kartus didesne paros doze už didžiausia rekomenduojama žmogui (400 mg), žiurkiu jaunikliams pasireiške nuo dozes priklausoma diafragmos išvarža, o triušiu - širdies bei kraujagysliu sistemos sklaidos ydu.
English: Elderly >65 years: As in younger adults, 200 mg per day should be used initially.
Lithuanian: Kaip ir jaunesniems suaugusiesiems, pradžioje vartojama 200 mg doze per para. Jei reikia, veliau doze galima didinti ir vartoti 200 mg du kartus per para.
English: Dialysis is unlikely to be an efficient method of drug removal due to high protein binding.
Lithuanian: Dialize neefektyvi, nes celekoksibas stipriai susijungia su baltymais.
English: 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.
Lithuanian: Jungtineje NVNU grupeje statistiškai reikšmingo opu komplikaciju skirtumo nebuvo (santykine rizika - 0,77, 95% PI 0,41-1,46, remiantis viso tyrimo duomenimis). Jungtinis ivertis rodo, kad opu komplikaciju ir simptomu celekosibo grupeje buvo reikšmingai mažiau nei NVNU grupeje (santykine rizika - 0,66, 95% PI 0,45-0,97), bet ne tarp celekoksibo ir diklofenako.
English: Patients with severe hepatic impairment (serum albumin <25 g/l) have not been studied and celecoxib is contraindicated in this patient group.
Lithuanian: Netirti pacientai, kuriems yra sunkus kepenu funkcijos sutrikimas (albumino koncentracija kraujo serume <25 g/l), todel jiems vartoti celekoksiba draudžiama.
English: Diaphragmatic hernia was also seen in a peri-post natal toxicity study in rats, which included exposure during the organogenetic period.
Lithuanian: Tiriant preparato toksini poveiki žiurkems perinataliniu, postnataliniu bei organogenezes laikotarpiais, taip pat nustatyta diafragmos išvarža.
English: Celecoxib is mainly eliminated by metabolism.
Lithuanian: Didele celekoksibo dalis metabolizuojama.
English: Breast feeding (See 4.6 and 5.3).
Lithuanian: Žindymo laikotarpis (žr. 4.6 ir 5.3 skyrius).
English: Celecoxib is an oral, selective, cyclooxygenase-2 (COX-2) inhibitor within the clinical dose range (200-400 mg daily).
Lithuanian: Celekoksibas, geriamas gydomosiomis dozemis (200-400 mg per para), yra aktyvus selektyvusis ciklooksigenazes 2 (COX-2) inhibitorius.
English: France
Lithuanian: Prancuzija
English: 5.1 Pharmacodynamic properties
Lithuanian: 5.1 Farmakodinamines savybes
English: 5.2 Pharmacokinetic properties
Lithuanian: 5.2 Farmakokinetines savybes
English: As for NSAIDs, the risk of acute renal insufficiency, which is usually reversible, may be increased in some patients with compromised renal function (e.g. dehydrated patients or elderly patients)when ACE inhibitors or angiotensin II receptor antagonists are combined with NSAIDs, including celecoxib.
Lithuanian: Kaip ir vartojant kitokiu NVNU, kai kuriems ligoniams, kuriu inkstu funkcija sutrikusi (pvz., daug skysciu netekusiems ar senyviems pacientams), NVNU, iskaitant celekoksiba, vartojant kartu su AKF inhibitoriais ar angiotenzino II receptoriu antagonistais gresia didesne uminio inkstu nepakankamumo, dažniausiai grižtamojo, rizika.
English: It may also play a role in ulcer healing.
Lithuanian: Galbut ji skatina gyti opas.
English: Very rare: aggravated epilepsy, meningitis aseptic, ageusia, anosmia
Lithuanian: Labai reti: epilepsijos pasunkejimas, aseptinis meningitas, skonio netekimas, kvapu nejutimas.
English: 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).
Lithuanian: Maždaug 4500 opu netureje pacientai dalyvavo penkiuose atsitiktiniu imciu kontroliuojamuosiuose dvigubai akluose tyrimuose (skirta nuo 50 mg iki 400 mg celekoksibo doze du kartus per para), kuriu metu atlikta planine viršutines virškinimo trakto dalies endoskopija.
English: No clinical data on exposed pregnancies are available for celecoxib.
Lithuanian: Klinikiniu tyrimu duomenu apie celekoksibo vartojima neštumo metu nera.
English: Pharmacokinetic interactions
Lithuanian: Farmakokinetine saveika
English: Celecoxib at daily doses of 200 mg - 400 mg provided pain relief within 24 hours of dosing.
Lithuanian: 200-400 mg celekoksibo paros doze per 24 valandas sumažino skausma.
English: Opaque, white with two gold bands marked 7767 and 200 (INVENTED NAME 200 mg).
Lithuanian: {Sugalvotas pavadinimas} 200 mg kapsules - nepermatomos, baltos, su auksine juosta ir užrašu 7767 bei 200.
English: In the submitted studies, as with other NSAIDs, an increased risk of gastrointestinal ulceration or other gastrointestinal complications compared to use of celecoxib alone was shown for concomitant administration of low-dose acetylsalicylic acid (see 5.1).
Lithuanian: Tyrimu duomenimis, kaip ir vartojant kitu NVNU, vieno celekoksibo sukeliamu virškinimo trakto opu ar kitu komplikaciju virškinimo trakte pavojus dideja vartojant ši preparata kartu su mažomis acetilsalicilo rugšties dozemis (žr.
English: Uncommon: anxiety, depression, tiredness Very rare: confusion, hallucinations.
Lithuanian: Nedažni: nerimas, depresija, nuovargis.
English: Vascular disorders Uncommon: hypertension, hypertension aggravated
Lithuanian: Nedažni: hipertenzija, hipertenzijos pasunkejimas.
English: Renal and urinary disorders Very rare: acute renal failure, interstitial nephritis
Lithuanian: Inkstu ir šlapimo taku sutrikimai Labai reti: uminis inkstu nepakankamumas, intersticinis nefritas.
English: Where full study reports are not available to the MAH, it agrees to provide publications/manuscripts in lieu of the study report(s).
Lithuanian: 3 klinikinis aspektas Kai bus galima, pateikti išsamias galutines tyrimu ataskaitas apie šiuos ilgalaikius tyrimus - APC/Pre-SAP/ADAPT. Jei registravimo liudijimo turetojas neturi išsamiu tyrimu ataskaitu, jis sutinka vietoj tyrimu ataskaitos (u) pateikti leidinius (rankrašcius).
English: 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).
Lithuanian: Saugumo tyrimu po vaistinio preparato registracijos duomenimis, pacientams, vartojusiems celekoksiba, labai retai pasireiške sunkiu, kartais mirtinu odos reakciju, iskaitant eksfoliacini dermatita, Stivenso ir Džonsono sindroma ir toksine epidermio nekrolize (žr. 4.8 skyriu).
English: Rare: ischaemic stroke* Very rare: vasculitis.
Lithuanian: Labai reti: vaskulitas.
English: 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).
Lithuanian: Vieni ju gydyti 400 mg celekoksibo doze du kartus per para (atitinkamai 4 ir 2 kartus didesne už rekomenduojama osteoartritui ir reumatoidiniam artritui gydyti), kiti - 800 mg ibuprofeno tris kartus per para, treti - 75 mg diklofenako du kartus per para (abieju preparatu doze gydomoji).
English: However, in healthy subjects, in small multiple dose studies with 600 mg BID (three times the highest recommended dose) celecoxib had no effect on platelet aggregation and bleeding time compared to placebo.
Lithuanian: Taciau nedidelio kartotiniu doziu tyrimo duomenimis, sveiku asmenu organizme tris kartus per para vartojama 600 mg celekoksibo doze, palyginti su placebu, neveike trombocitu agregacijos ir kraujavimo laiko.
English: General disorders and administration site conditions Common: peripheral oedema/ fluid retention
Lithuanian: Bendri sutrikimai ir vartojimo vietos pažeidimai Nedažni: periferine edema ir skyscio kaupimasis.
English: Celecoxib is excreted in the milk of lactating rats at concentrations similar to those in plasma.
Lithuanian: Tiriant žiurkes, nustatyta, kad celekoksibo koncentracija piene beveik prilygsta jo koncentracijai kraujo plazmoje.
English: 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.
Lithuanian: 7,1% pacientu, vartojusiu celekoksiba, ir 6,1% - placeba nutrauke gydyma del nepageidaujamo poveikio.
English: The metabolic capacity in patients with mild to moderate impairment was best correlated to their albumin values.
Lithuanian: Metabolizmo pajegumas pacientu, serganciu nesunkiu ir vidutinio sunkumo kepenu sutrikimu, organizme susijes su albumino koncentracija.
English: Psychiatric disorders Common: insomnia
Lithuanian: Psichikos sutrikimai Dažni: nemiga.
English: Clinical 2
Lithuanian: KLINIKINE INFORMACIJA
English: Inflammatory bowel disease.
Lithuanian: Nedažni: šlapimo taku infekcines ligos.
English: 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).
Lithuanian: Ilgalaikiu klinikiniu tyrimu, kuriu metu buvo palygintas vienu metu vartojamu COX-2 inhibitoriu ir acetilsalicilo rugšties derinio su NVNU ir acetilsalicilo rugšties derinio vartojimu, saugumo VT duomenys reikšmingai nesiskyre (žr.
English: The inter-subject variability in the exposure of celecoxib is about 10-fold.
Lithuanian: Ivairiu žmoniu organizme celekoksibo farmakokinetika skiriasi apie 10 kartu.
English: Additional reactions reported from post-marketing experience in >70 million treated patients include headache, nausea and arthralgia, and the reactions included as very rare, in italics in the list below.
Lithuanian: Paskelbtos ir papildomos reakcijos, tokios kaip galvos skausmas, pykinimas, artralgija, bei labai reti ir pavieniai atvejai, išvardyti toliau kursyvu, kurie pasireiške, idiegus vaista i rinka ir pavartojus vaistini preparata daugiau kaip 70 milijonu pacientu.
English: In pregnancy and in women of childbearing potential unless using an effective method of contraception (See 4.5).
Lithuanian: Preparato negalima vartoti ir vaisingo amžiaus moterims, nesinaudojancioms veiksmingu kontracepcijos metodu (žr. 4.5 skyriu). Celekoksibas sukele apsigimimu dvieju tirtu rušiu gyvunams (žr. 4.6 ir 5.3 skyrius).
English: In patients with rheumatoid arthritis celecoxib had no statistically significant effect on the pharmacokinetics (plasma or renal clearance) of methotrexate (in rheumatologic doses).
Lithuanian: Reumatoidiniu artritu serganciu pacientu organizme celekoksibas nekeite metotreksato, vartojamo doze, kuria gydomas reumatas, farmakokinetikos (klirenso plazmoje ar inkstuose).
English: 4.6 Pregnancy and lactation
Lithuanian: Infekcijos ir infestacijos
English: Very rare: gastrointestinal haemorrhage, acute pancreatitis, colitis/colitis aggravated.
Lithuanian: Labai reti: kraujavimas iš virškinimo trakto, uminis pankreatitas, kolitas ir kolito pasunkejimas.
English: § Further to the assessment of the data on serious skin reactions, celecoxib is associated with very rare occurrence of serious skin reactions, as evidenced in clinical studies and post marketing surveillance, which analysis revealed several risk factors for the occurrence of theseserious skin reactions with celecoxib.
Lithuanian: § Ivertinus duomenis apie sunkias odos reakcijas, celecoxibas siejamas su labai retai pasitaikanciomis sunkiomis odos reakcijomis.
English: The dose of individually dose-titrated CYP2D6 substrates may need to be reduced when treatment with celecoxib is initiated or increased if treatment with celecoxib is terminated.
Lithuanian: Pradejus gydyti celekoksibu, kartais kai kuriu CYP2D6 metabolizuojamu preparatu jau nustatyta doze tenka sumažinti, o nutraukus gydyma celekoksibu - vel padidinti.
English: In one of the three studies, the APC (Prevention of Sporadic Colorectal Adenomas with Celecoxib), there was a dose-related increase in cardiovascular events (mainly myocardial infarction, MI) at celecoxib doses of 200 mg BID and 400 mg BID compared to placebo.
Lithuanian: Prevention of Sporadic Colorectal Adenomas with Celecoxib, APC), nustatytas nuo dozes priklausomas (200 mg ir 400 mg dozes du kartus per para, palyginti su placebu) širdies ir kraujagysliu sistemos sutrikimu (daugiausia miokardo infarkto, MI) padažnejimas.
English: Rare: duodenal, gastricoesophageal, intestinal and colonic ulceration, dysphagia, intestinal perforation, oesophagitis, melaena
Lithuanian: Reti: dvylikapirštes žarnos, skrandžio, stemples, plonosios ir storosios žarnu išopejimai, disfagija, žarnyno perforacija, ezofagitas, melena.
English: mg twice daily have been administered to healthy subjects for nine days without clinically significant adverse effects.
Lithuanian: Sveikiems žmonems vienkartines iki 1200 mg ir kartotines iki 1200 mg dozes du kartus per para, vartotos 9 dienas, kliniškai reikšmingo nepageidaujamo poveikio nesukele.
English: Uncommon: urticaria
Lithuanian: Dažni: išberimas.
English: Hepatic impairment: Treatment should be initiated at half the recommended dose in patients with established moderate liver impairment with a serum albumin of 25-35 g/l.
Lithuanian: Pacientus, kurie serga vidutinio sunkumo kepenu sutrikimu (albumino koncentracija kraujo serume 25-35 g/l), reikia pradeti gydyti puse rekomenduojamos dozes.
English: 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.
Lithuanian: Gydymo celekoksibu poveikis uždegimui ir skausmui ivertintas 12 savaiciu trukmes placebu ir (arba) aktyviai kontroliuojamais tyrimais, kuriuose dalyvavo 4200 kelio ir klubo osteoartritu serganciu pacientu, ir 24 savaiciu trukmes tokiais pat tyrimais, kuriuose dalyvavo apie 2100 pacientu, serganciu reumatoidiniu artritu.
English: 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.
Lithuanian: Organizme sveiku asmenu, vartojanciu 200 mg celekoksibo du kartus per para kartu su 450 mg licio du kartus per para, licio Cmax padidejo vidutiniškai 16%, o AUC - 18%. Jei greta licio preparatu pradedama gydyti celekoksibu arba jo vartojimas nutraukiamas, pacienta reikia nuodugniai ištirti.
English: Opaque, white with two blue bands marked 7767 and 100 (INVENTED NAME 100 mg).
Lithuanian: {Sugalvotas pavadinimas} 100 mg kapsules - nepermatomos, baltos, su melyna juosta ir užrašu 7767 bei 100.
English: Pharmacological activity resides in the parent drug.
Lithuanian: Nepakites preparatas yra farmakologiškai aktyvus.
English: A dose dependent effect on TxB2 formation has been observed after high doses of celecoxib.
Lithuanian: Vartojant dideles celekoksibo dozes, nustatytas nuo dozes priklausomas poveikis TxB2 susidarymui.
English: The MAH commits to performing a global CV study to confirm long term CV safety of Celecoxib.
Lithuanian: 1 klinikinis aspektas Registravimo liudijimo turetojas isipareigoja atlikti bendra širdies ir kraujagysliu sistemos tyrima ir patvirtinti ilgalaiki celekoksibo sauguma širdies ir kraujagysliu sistemai.
English: Patients known to be CYP2C9 poor metabolisers should be treated with caution.
Lithuanian: Atsargiai preparatu reikia gydyti pacientus, kuriu organizme CYP2C9 metabolizuoja silpnai.
English: Luxembourg
Lithuanian: Liuksemburgo Kunygaikštyste
English: Serious hypersensitivity reactions (anaphylaxis and angioedema) have been reported in patients receiving celecoxib (see 4.8).
Lithuanian: Pacientams, vartojusiems celekoksiba, pasireiške sunkiu padidejusio jautrumo reakciju (anafilaksija ir angiodema) (žr.
English: Renal impairment: Experience with celecoxib in patients with mild or moderate renal impairment is limited, therefore such patients should be treated with caution.
Lithuanian: Rekomenduojama atsargiai celekoksibu gydyti pacientus, kuriems yra nesunkus ar vidutinio sunkumo inkstu funkcijos sutrikimas, nes stokojama tokiu ligoniu gydymo patirties (žr.
English: In a peri-post natal study in rats, pup toxicity was observed.
Lithuanian: Tiriant žiurkes perinataliniu ir postnataliniu laikotarpiais, nustatyta, kad preparatas sukelia toksini poveiki ju jaunikliams.
English: Infections and infestations Common: sinusitis, upper respiratory tract infection Uncommon: urinary tract infection
Lithuanian: Dažni: sinusitas, viršutiniu kvepavimo taku infekcines ligos.
English: There is no clinical experience of overdose.
Lithuanian: Klinikiniu perdozavimo požymiu nenustatyta.
English: Bleeding events in association with increases in prothrombin time have been reported, predominantly in the elderly, in patients receiving celecoxib concurrently with warfarin, some of them fatal.
Lithuanian: Del ilgo protrombino laiko pacientams, ypac senyviems, kurie vartojo celekoksiba kartu su varfarinu, prasidejo kraujavimas, kartais pasibaiges mirtimi.
English: 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).
Lithuanian: Tu paciu tyrimu duomenimis, trejus metus gydant 400 mg celekoksibo paros doze 1000 pacientu teko 0,5 išeminio insulto (išskyrus reiškinius, kai buvo hemoragiju arba nežinoma etiologija) atvejo daugiau (retai) nei vartojant placeba.
English: Pharmacodynamic interactions
Lithuanian: Farmakodinamine saveika
English: 1 NAME OF THE MEDICINAL PRODUCT {INVENTED NAME, see Annex I} 100 mg capsule, hard.
Lithuanian: {Sugalvotas pavadinimas} 100 mg kietos kapsules.
English: Treatment should be initiated at half the recommended dose in patients with moderate liver impairment (with serum albumin 25-35g/L).
Lithuanian: Ligoniams, kuriems yra vidutinio sunkumo kepenu funkcijos sutrikimas (albumino koncentracija kraujo serume - 25-35 g/l), iš pradžiu skiriama puse rekomenduojamos preparato dozes.
English: Celecoxib exhibits dose- and time-independent pharmacokinetics in the therapeutic dose range.
Lithuanian: Gydomuju celekoksibo doziu farmakokinetika nepriklauso nuo dozes ir laiko.
English: 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.
Lithuanian: Išankstiniais kitu dvieju tyrimu duomenimis, vartojant 200 mg celekoksibo doze du kartus per para ir400 mg celekoksibo doze viena karta per para, palyginti su placebu, širdies ir kraujagysliu reiškiniu rizika reikšmingai nepadidejo.