FrancophonIA/ELRC3.0 huggingface dataset:
English: For the subgroup of patients with disease limited to non-visceral metastasis (n=208), the HR was 0.592 (95% CI: 0.419, 0.837) for the fulvestrant arm compared to the anastrozole arm. For the subgroup of patients with visceral metastasis (n=254), the HR was 0.993 (95% CI: 0.740, 1.331) for the fulvestrant arm compared to the anastrozole arm.
Lithuanian: Palyginus fulvestranto ir anastrozolo grupes, visceralinių metastazių neturėjusių pacienčių (n = 208) pogrupio HR buvo 0,592 (95 % PI - nuo 0,419 iki 0,837).
English: IM use
Lithuanian: Išbėrimase
English: Interference with estradiol antibody assays
Lithuanian: Įtaka antikūnais pagrįstų estradiolio tyrimų rezultatams
English: Joint and musculoskeletal pain
Lithuanian: Skeleto ir raumenų skausmasd dažnas
English: Progression-free survival was the primary endpoint.
Lithuanian: Gydymo veiksmingumo pirminė vertinamoji baigtis buvo neprogresuojant ligai išgyventas laikotarpis.
English: Fulvestrant has been shown to cross the placenta after single intramuscular doses in rat and rabbit.
Lithuanian: 4.3 skyrių). Nustatyta, kad suleidus vieną fulvestranto dozę žiurkei ar triušiui į raumenis, fulvestrantas prasiskverbia per placentos barjerą.
English: Patients with advanced/metastatic, symptomatic, visceral spread, that were at risk of life-threatening complications in the short term (including patients with
Lithuanian: Progresavusiu ar metastazavusiu, simptominiu, turėjusių visceralinių metastazių vėžiu sirgusių pacienčių nebuvo leidžiama įtraukti į šį tyrimą, jei buvo gyvybei pavojingų komplikacijų rizika trumpuoju laikotarpiu esant didelių nekontroliuojamų efuzijų (pleuroje, perikarde ar pilvaplėvėje), plaučių limfangitui arba daugiau kaip 50 % pažeistoms kepenims.
English: NAME OF THE MEDICINAL PRODUCT Fulvestrant Mylan 250 mg solution for injection in prefilled syringe
Lithuanian: VAISTINIO PREPARATO PAVADINIMAS Fulvestrant Mylan 250 mg injekcinis tirpalas užpildytame švirkšte
English: Two clear type 1 glass pre-filled syringes with polypropylene plunger rod, fitted with a tamper-evident closure, each containing 5 ml Fulvestrant Mylan solution for injection.
Lithuanian: Užpildytą švirkštą sudaro: vienas skaidraus 1 tipo stiklo užpildytas švirkštas (jame yra 5 ml Fulvestrant Mylan injekcinio tirpalo) su polipropileniniu stūmokliu ir pirmojo atidarymo kontrolės uždoriu bei kartu pateikiama saugi adata (BD SafetyGlide), kuri tvirtinama prie korpuso; arba du skaidraus 1 tipo stiklo užpildyti švirkštai (juose yra po 5 ml Fulvestrant Mylan injekcinio tirpalo) su polipropileniniu stūmokliu ir pirmojo atidarymo kontrolės uždoriu bei kartu pateikiamos saugios adatos (BD SafetyGlide), kurios tvirtinamos prie kiekvieno švirkšto korpuso.
English: N=number of patients; CI=confidence interval; OR= objective response; TTR=time to first tumour response.
Lithuanian: N - pacienčių skaičius, PI - pasikliautinasis intervalas, OR (angl.
English: Fulvestrant is contraindicated in pregnancy (see section 4.3).
Lithuanian: Nėštumo laikotarpiu fulvestranto vartoti negalima (žr.
English: Safety and efficacy have not been evaluated in patients with severe renal impairment (creatinine clearance <30 ml/min), and, therefore, caution is recommended in these patients (see section 4.4).
Lithuanian: ), šio vaisto saugumas ir veiksmingumas netirtas, todėl joms jo skiriama atsargiai (žr.
English: After
Lithuanian: KITA
English: Combined analysis of both studies showed that 83% of patients who received fulvestrant progressed, compared with 85% of patients who received anastrozole.
Lithuanian: Abiejų tyrimų bendra analizė parodė, kad progresavo 83 % fulvestrantą ir 85 % anastrozolą vartojusių pacienčių liga. Kombinuota abiejų tyrimų rezultatų analizė parodė, kad pagal neprogresuojant ligai išgyventą laikotarpį apskaičiuota santykinė rizika, palyginus fulvestranto 250 mg dozę ir anastrozolą vartojusias pacientes, buvo 0,95 (95 % PI - 0,821,10).
English: For user convenience, the needle bevel- up position is oriented to the lever arm (see Figure 4).
Lithuanian: Kad adata būtų patogiau naudotis, jos smaigalio nuožulnuma yra toje pačioje pusėje kaip svirtelė (4 pav.).
English: Addition of palbociclib to fulvestrant resulted in a symptom benefit by significantly delaying Time-to-Deterioration in pain symptom compared with fulvestrant plus placebo (median 8.0 months versus 2.8 months; HR of 0.64 [95% CI: 0.49, 0.85]; p<0.001).
Lithuanian: reikšmingai ilgesnis laikotarpis iki skausmo sustiprėjimo negu vartojant fulvestrantą plius placebą (jo mediana buvo atitinkamai 8,0 mėn.
English: Tel: +31 (0)20 426 3300
Lithuanian: Tél/Tel: + 32 (0)2 658 61 00
English: You must not use Fulvestrant Mylan if you are pregnant.
Lithuanian: Duodant fulvestranto žiurkių patelėms, nutrūkdavo nėštumas.
English: Time from randomisation (months)
Lithuanian: duration of response) - atsako trukmė
English: This information will be updated as final data become available.
Lithuanian: Ši informacija bus atnaujinta, kai tik bus gauti galutiniai duomenys.
English: 1515 Lefkosia Cyprus
Lithuanian: 1515 Lefkosia Kipras
English: LT-01112 Vilnius Lithuania
Lithuanian: LT-01112 Vilnius Lietuva
English: Via Robert Koch, 1-2 20152 Milano Italy
Lithuanian: Via Robert Koch, 1-2 20152 Milano Italija
English: Elimination half-life is 8-12 hours.
Lithuanian: Pusines eliminacijos laikas - 8-12 valandu.
English: Rivium Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands
Lithuanian: Rivium Westlaan 142 2909 LD Capelle a/d IJssel Nyderlandai
English: 7 MARKETING AUTHORISATION HOLDER {Name and address} [Country name in the language of the text, NO telephone, fax numbers, e-mail addresses or websites.]
Lithuanian: REGISTRAVIMO LIUDIJIMO TURETOJAS {Pavadinimas ir adresas} [Šalies pavadinimas teksto kalba, telefono nr., fakso nr., elektroninio pašto adresas ar internetinis puslapis.
English: [Very Common (>1/10), Common (³1/100, <1/10) Uncommon (³1/1000, <1/100) Rare (³1/10,000, <1/1000) Very rare (<1/10,000 including isolated cases)]
Lithuanian: [Labai dažni (>1/10), dažni (³1/100, <1/10), nedažni (³1/1000, <1/100), reti (³1/10 000, <1/1000) labai reti (<1/10 000, iskaitant pavienius atvejus)].
English: 1324 Lysaker Norway
Lithuanian: 1324 Lysaker Norvegija
English: Lagoas Park, Edifício n.º 10 2740-244 Porto Salvo Portugal
Lithuanian: Lagoas Park, Edifício n.º 10 2740-244 Porto Salvo Portugalija
English: 76139 Karlsruhe Germany
Lithuanian: 76139 Karlsruhe Vokietija
English: On 23 June 2005, the CHMP concluded that:
Lithuanian: CHMP nusprende, jog:
English: Pfizer ApS Lautrupvang 8 2750 Ballerup Denmark
Lithuanian: Pfizer ApS Lautrupvang 8 2750 Ballerup Danija
English: 4.7 Effects on ability to drive and use machines
Lithuanian: 4.7 Poveikis gebejimui vairuoti ir valdyti mechanizmus
English: The increased risk became apparent after approximately 1 year of treatment.
Lithuanian: Rizikos padidejimas pastebetas maždaug po vieneriu metu gydymo.
English: Avenida de Europa, 20-B Parque Empresarial La Moraleja 28108 Alcobendas, Madrid Spain
Lithuanian: Avenida de Europa, 20-B Parque Empresarial La MGertieja 28108 Alcobendas, Madrid Ispanija
English: Milton Keynes MK5 8PH United Kingdom
Lithuanian: Milton Keynes MK5 8PH Jungtine Karalyste
English: Final study reports will be shared with Agencies when available.
Lithuanian: Užbaigus galutiniu tyrimu ataskaitas, apie jas bus pranešta ir agenturoms.
English: To continue to make available emerging clinical and epidemiological data through publications and, where possible, in scientific congresses.
Lithuanian: It toliau skelbti naujai gaunamus klinikinius ir epidemiologinius duomenis leidiniuose, ir, kai imanoma, moksliniu kongresu metu.
English: Pfizer Luxembourg SARL, 283, route d'Arlon, L-8011 Strassen, Luksemburg
Lithuanian: Pfizer Luxembourg SARL, 283, route d'Arlon, L-8011 Strassen, Liuksemburgo Kunigaikštyste
English: {Invented name}may be taken with or without food.
Lithuanian: {Sugalvotas pavadinimas} galima gerti ir valgant, ir nevalgius.
English: After the Commission Decision, the Member State competent authorities will update the product information as required.
Lithuanian: Kaip reikalaujama, po Komisijos sprendimo valstybes nares kompetetingos istaigos atnaujina informacija apie preparata.
English: {Invented Name}100 mg and 200 mg capsules contain lactose (149.7 mg and 49.8 mg, respectively).
Lithuanian: {Sugalvotas pavadinimas} 100 mg ir 200 mg kapsulese yra laktozes (atitinkamai 149,7 mg ir 49,8 mg).
English: The potential for human risk in pregnancy is unknown, but cannot be excluded.
Lithuanian: Galima rizika neštumo metu žmogui, nežinoma, bet jos negalima paneigti.
English: NSAIDs may reduce the effect of diuretics and antihypertensive medicinal products.
Lithuanian: NVNU gali slopinti diuretiku ir antihipertenziniu vaistiniu preparatu poveiki.
English: Further to a request from the European Commission, the scope of the ongoing class was broadened review to include the assessment of serious skin reactions in addition to the cardiovascular safety aspects.
Lithuanian: Europos Komisijai pateikus prašyma, esamos klases taikymo sritis buvo peržiureta placiau, siekiant kartu su širdies ir kraujagysliu saugumo aspektais itraukti sunkias odos reakcijas.
English: There is a genetic polymorphism of this enzyme.
Lithuanian: Nustatytas genetinis šio fermento polimorfizmas.
English: Very rare: myositis
Lithuanian: Labai reti: miozitas.
English: Pfizer Europe MA EEIG Ramsgate Road Sandwich
Lithuanian: Slovakijos Respublika Pfizer Europe MA EEIG Ramsgate Road
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND
Lithuanian: I PRIEDAS VAISTINIO PREPARATO PAVADINIMAI, VAISTO FORMOS, STIPRUMAI, VARTOJIMO BUDAI IR REGISTRAVIMO LIUDIJIMO TURETOJAI EUROPOS SAJUNGOS ŠALYSE NARESE IR NORVEGIJOJE BEI ISLANDIJOJE
English: Congestive heart failure (NYHA II-IV).
Lithuanian: Stazinis širdies nepakankamumas (II-IV klases pagal NYHA).
English: Two isoforms, COX-1 and COX-2, have been identified.
Lithuanian: Žinomos dvi fermento izoformos - COX-1 ir COX-2.
English: 4.1 Therapeutic indications
Lithuanian: 4.1 Terapines indikacijos
English: Kent CT13 9NJ United Kingdom
Lithuanian: Kent CT13 9NJ
English: Patients with estimated creatinine clearance <30 ml/min.
Lithuanian: Kreatinino klirensas <30 ml/min.
English: The CHMP confirmed changes to the Product Information already introduced through a type II variation adopted in May 2005 further to the February USR and requested further changes.
Lithuanian: CHMP jau patvirtino Preparato informacijos pakeitimus, kurie buvo pateikti II tipo variacijoje, priimtoje 2005 m.
English: The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3, 4.4).
Lithuanian: Skirti pacientui selektyvu COX-2 inhibitoriu galima tik ivertinus bendra rizika asmeniškai pacientui (žr. 4.3 ir 4.4 skyrius).
English: The corresponding values in patients with moderate hepatic impairment were 41% and 146% respectively.
Lithuanian: Rodmenys pacientu, kuriems yra vidutinio sunkumo kepenu funkcijos sutrikimas, - atitinkamai 41% ir 146%.
English: Dosing with food (high fat meal) delays absorption by about 1 hour.
Lithuanian: Celekoksibas, vartojamas su maistu (labai riebiu), absorbuojamas maždaug viena valanda ilgiau.
English: Concomitant use of inducers of CYP2C9 such as rifampicin, carbamazepine and barbiturates may reduce plasma concentrations of celecoxib.
Lithuanian: Kartu vartojant CYP2C9 sužadinanciu preparatu, pavyzdžiui, rifampicina, karbamazepina ir barbituratu, gali sumažeti celekoksibo koncentracija plazmoje.
English: Ramsgate Road Sandwich Kent CT13 9NJ England
Lithuanian: Ramsgate Road Sandwich Kent CT13 9NJ Jungtine Karalyste
English: Follow-up measures of the Marketing Authorisation Holder As requested by the CHMP, the MAH agreed to submit the follow-up measures as listed below:
Lithuanian: Registravimo liudijimo turetojo tolesnio tyrimo priemones CHMP prašymu registravimo liudijimo turetojas sutiko pateikti tolesnes tyrimo priemones, kurios nurodytos žemiau:
English: To submit an analysis of spontaneous reports for all serious skin reactions from the analysis of the RegiSCAR database and further discuss results with Rapporteur following submission.
Lithuanian: 2 klinikinis aspektas Pateikti gautu pranešimu apie visas sunkias odos reakcijas analize išanalizavus RegiSCAR duomenu baze, o po pateikimo toliau nagrineti rezultatus su pranešeju.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Lithuanian: 4.5 Saveika su kitais vaistiniais preparatais ir kitokia saveika
English: During the CHMP meeting of February 2005, discussions on cardiovascular safety took place.
Lithuanian: vasario menesi vykusiame CHMP posedyje buvo svarstomas širdies ir kraujagysliu saugumo klausimas.
English: Particular caution should be exercised in elderly with a body weight less than 50 kg. (See 4.4 and 5.2).
Lithuanian: Labai atsargiai preparata reikia vartoti senyviems pacientams, kurie sveria mažiau kaip 50 kg (žr. 4.4 ir 5.2 skyrius).
English: 5.3 Preclinical safety data
Lithuanian: 5.3 Ikiklinikiniu saugumo tyrimu duomenys
English: ANNEX IV CONDITIONS OF THE MARKETING AUTHORISATION
Lithuanian: IV PRIEDAS REGISTRAVIMO LIUDIJIMO SUTEIKIMO SALYGOS
English: Member State
Lithuanian: Valstybe nare
English: 4.4 Special warnings and special precautions for use
Lithuanian: 4.4 Specialus ispejimai ir atsargumo priemones
English: If a woman becomes pregnant during treatment, celecoxib should be discontinued.
Lithuanian: 4.3 ir 4.4 skyrius). Jeigu moteris pastojo gydymo metu, celekoksibo vartojima reikia nutraukti.
English: Known hypersensitivity to sulphonamides.
Lithuanian: Padidejes jautrumas sulfonamidams.
English: 6.5 Nature and content of container
Lithuanian: 6.5 Pakuote ir jos turinys
English: These effects are expected following inhibition of prostaglandin synthesis.
Lithuanian: Manoma, kad toks poveikis pasireiškia del slopinamos prostaglandinu sintezes.
English: The clinical significance of this in vitro finding is unknown.
Lithuanian: Klinikine šio reiškinio svarba nežinoma.
English: Lab. Medinfar - Produtos Farmacêuticos S.A. R. Manuel Ribeiro de Pavia, n.º1 - Venda Nova 2700-547 Amadora
Lithuanian: Manuel Ribeiro de Pavia, n.º1 - Venda Nova 2700-547 Amadora
English: Capsule, hard.
Lithuanian: Kietos kapsules.
English: Corporation Representation Office in Lithuania A. Gostauto 40 a
Lithuanian: Corporation Representation Office in Lithuania A.
English: Furthermore, the MAH commits to continue dialogue with EMEA/CHMP with regard to study design
Lithuanian: Registravimo liudijimo turetojas taip pat isipareigoja testi dialoga su EMEA/CHMP del tyrimu rengimo.
English: COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions (fever induction, pain perception and cognitive function).
Lithuanian: Be to, COX-2 daro itaka ovuliacijai, implantacijai ir arterinio latako užakimui, reguliuoja inkstu funkcija ir centrines nervu sistemos funkcijas (karšciavimo sužadinima, skausmo jutima, pažintine funkcija).
English: Steady state plasma concentrations are reached within 5 days of treatment.
Lithuanian: Pusiausvyrine koncentracija kraujo plazmoje susidaro per 5 dienas.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Lithuanian: Pacientams, kuriems yra paveldimas gliukozes netoleravimas, Lapp laktazes stoka ar gliukozes ir galaktozes malabsorbcija, šio preparato vartoti negalima.
English: Clear or opaque PVC blisters or aluminium cold-formed blisters.
Lithuanian: Permatomos arba nepermatomos PVC lizdines plokšteles arba aliuminio folijos lizdines plokšteles.
English: Celecoxib is a diaryl-substituted pyrazole, chemically similar to other non-arylamine sulfonamides (e.g. thiazides, furosemide) but differs from arylamine sulfonamides (e.g. sulfamethoxizole and other sulfonamide antibiotics).
Lithuanian: Celekoksibas yra pirazolas su pakeista diarilo grupe, cheminiu požiuriu panašus i kitus ne arilamino sulfonamidus (pvz., tiazida, furozemida), bet skiriasi nuo arilamino sulfonamidu (pvz., sulfametoksizolio, kitu sulfonamidiniu antibiotiku).
English: Since celecoxib is predominantly metabolised by CYP2C9 it should be used at half the recommended dose in patients receiving fluconazole.
Lithuanian: Kadangi celekoksibas daugiausiai metabolizuojamas CYP2C9, reikia vartoti tik puse rekomenduojamos jo dozes pacientams, kurie gydomi flukonazoliu.
English: Celecoxib is well absorbed reaching peak plasma concentrations after approximately 2-3 hours.
Lithuanian: Celekoksibas gerai absorbuojamas ir didžiausia jo koncentracija kraujo plazmoje susidaro maždaug po 2-3 valandu.
English: (See 4.3, 4.4 and 5.2).
Lithuanian: 4.3, 4.4 ir 5.2 skyrius).
English: Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment.
Lithuanian: Gydymo pradžioje tokiu reakciju tikimybe pacientui didesne: daugeliu atveju reakcijos prasideda per pirmaji gydymo menesi.
English: Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Lithuanian: Nustatyta išemine širdies liga, periferiniu arteriju liga ir (arba) smegenu kraujotakos liga.
English: The maximum recommended daily dose is 400 mg for both indications.
Lithuanian: Didžiausia rekomenduojama doze abieju indikaciju atveju - 400 mg per para.
English: ANNEX III SUMMARY OF THE PRODUCT CHARACTERISTICS Note: This SPC is the one that was Annexed to the Commission Decision on this Article 31 referral for celecoxib containing medicinal products.
Lithuanian: Pastaba: ši Preparato charakteristiku santrauka yra vienintelis priedas, kuris buvo pridetas prie Komisijos sprendimo del šios kreipimosi proceduros, kurios buvo imtasi remiantis 31 straipsniu del vaistu, kuriu sudetyje yra celekoksibo.
English: If during treatment, patients deteriorate in any of the organ system functions described above, appropriate measures should be taken and discontinuation of celecoxib therapy should be considered.
Lithuanian: Jei gydymo metu pablogeja kurios nors anksciau minetos paciento organu sistemos funkcija, reikia imtis atitinkamu priemoniu ir apsvarstyti, ar reikia nutraukti celekoksibo vartojima.
English: In animals, exposure to celecoxib during early embryonic development resulted in pre-implantation and post-implantation losses.
Lithuanian: Duodant celekoksibo gyvunams ankstyvuoju embrioniniu laikotarpiu, ivyko persileidimu prieš implantacija ir po jos.
English: - recommended follow up measures to further investigate the safety of celecoxib.
Lithuanian: - rekomendavo inicijuoti ilgalaikius tyrimus, kuriais butu siekiama ištirti celekoksibo sauguma,
English: Cardiac disorders Uncommon: myocardial infarction*, heart failure, palpitations
Lithuanian: Širdies sutrikimai Nedažni: miokardo infarktas *, širdies nepakankamumas, palpitacija.
English: The main metabolites found in the circulation have no detectable COX-1 or COX-2 activity.
Lithuanian: Pagrindiniai kraujyje cirkuliuojantys celekoksibo metabolitai neslopina COX-1 arba COX-2.
English: COX-2 selective inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
Lithuanian: Selektyvieji COX-2 inhibitoriai mažina sisteminio (taigi galbut ir endotelinio) prostaciklino susidaryma, neveikdamas trombocitu tromboksanui.
English: Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ³10).
Lithuanian: Sunkus kepenu funkcijos sutrikimas (albumino koncentracija kraujo serume <25 g/l arba =10 balu pagal Child-Pugh).
English: Examples of drugs which are metabolised by CYP2D6 are antidepressants (tricyclics and SSRIs), neuroleptics, antiarrhythmic drugs, etc.
Lithuanian: Pavyzdžiui, CYP2D6 metabolizuoja antidepresantus (triciklius ir SSRI), neuroleptikus, antiaritminius preparatus ir kt.
English: 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.]
Lithuanian: PIRMOJO REGISTRAVIMO ARBA PERREGISTRAVIMO DATA [Irašys registravimo liudijimo turetojas po preparato registracijos arba perregistracijos.
English: Less than 1% of the dose is excreted unchanged in urine.
Lithuanian: Mažiau kaip 1% nepakitusio preparato išsiskiria su šlapimu.
English: The following events have been reported in patients receiving celecoxib in 12 placebo and/or active controlled trials.
Lithuanian: Toliau nurodyti nepageidaujami reiškiniai, kurie pasireiške celekoksiba vartojusiems pacientams 12-os placebu ir (arba) aktyviai kontroliuojamu tyrimu metu.
English: Very rare: angioedema, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, epidermal necrolysis,
Lithuanian: Labai reti: angioedema, eksfoliacinis dermatitas, daugiaforme eritema, Stivenso ir Džonsono sindromas, epidermio nekrolize.
English: Pfizer Hellas A. E. 5, Alketou Street 116 33 Athens Greece
Lithuanian: 5, Alketou Street 116 33 Athens Graikija
English: 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.
Lithuanian: Astma, uminis rinitas, nosies polipai, angioneurozine edema, dilgeline arba kitokia alergine reakcija, kurios buvo pavartojus acetilsalicilo rugšties arba NVNU, iskaitant COX-2 (ciklooksigenazes 2) inhibitorius.
English: Metabolism and nutrition disorders Uncommon: hyperkalaemia
Lithuanian: Metabolizmo ir mitybos sutrikimai Nedažni: hiperkaliemija.
English: On 20 April 2005, Pfizer presented data on serious skin reactions for valdecoxib during a hearing.
Lithuanian: vykusio išklausymo metu Pfizer pristate duomenu apie valdekoksibo sukeltas sunkias odos reakcijas.
English: SCIENTIFIC CONCLUSIONS FOR THE AMENDMENT OF THE MARKETING AUTHORISATION
Lithuanian: MOKSLINES IŠVADOS, PADARYTOS SIEKIANT PATAISYTI REGISTRAVIMO LIUDIJIMA
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
Lithuanian: II PRIEDAS EUROPOS VAISTU AGENTUROS PATEIKTOS MOKSLINES IŠVADOS IR PREPARATO CHARAKTERISTIKU SANTRAUKOS PATAISU PAGRINDIMAS
English: Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.
Lithuanian: Simptominis osteoartrito ir reumatoidinio artrito gydymas.
English: In September 2004, the Marketing Authorisation Holder (MAH) of rofecoxib (a selective Cox-2inhibitor) informed the EMEA that new clinical trial (APPROVe) data for rofecoxib have revealed a risk of thrombotic cardiovascular (CV) events.
Lithuanian: rugsejo menesi rofekoksibo (selektyvaus Cox-2 inhibitoriaus) registravimo liudijimo turetojas (RLT) informavo Europos vaistu agentura (EMEA), jog naujo klinikinio tyrimo (APPROVe) duomenys apie rofekoksiba atskleide tromboziniu širdies ir kraujagysliu sutrikimu rizika.
English: Immune system disorders: Very rare: serious allergic reactions, anaphylactic shock
Lithuanian: Imunines sistemos sutrikimai Labai reti: sunkios alergines reakcijos, anafilaksinis šokas.
English: 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.
Lithuanian: Kadangi didinant celekoksibo doze ir vartojimo trukme gresia didesne širdies ir kraujagysliu sutrikimu rizika, reikia vartoti vaisto kiek imanoma trumpiau ir mažiausia veiksminga paros doze.
English: Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with celecoxib after careful consideration (see 5.1).
Lithuanian: Pacientus, kuriems yra svarbiu širdies ir kraujagysliu sutrikimu rizikos veiksniu (pvz.: hipertenzija, hiperlipidemija, cukrinis diabetas, rukymas), gydyti celekoksibu galima tik kruopšciai apsvarscius (žr.