FrancophonIA/ELRC3.0 huggingface dataset:
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.
Latvian: 2004. gada septembri rofecoxib (selektiva COX-2 inhibitora) registracijas apliecibas ipašnieks informeja EMEA, ka jaunie rofecoxib kliniska petijuma (APPROVe) dati ir atklajuši trombus veidojošu kardiovaskularo iedarbibu.
English: The Netherlands
Latvian: The Netherlands Niderlande
English: After the Commission Decision, the Member State competent authorities will update the product information as required.
Latvian: Pec Komisijas lemuma dalibvalstu kompetentas iestades atjauninas produkta informaciju pec vajadzibas.
English: These data resulted in the worldwide withdrawal of Vioxx (rofecoxib) from the market on 30 September 2004 by the MAH and raised questions regarding the cardiovascular safety of other Cox-2 inhibitors.
Latvian: Šo datu ietekme apliecibas ipašnieks 2004. gada 30. septembri iznema Vioxx (rofecoxib) no tirgus visa pasaule un ierosinaja jautajumu par citu COX-2 inhibitoru kardiovaskularo drošibu.
English: Less than 1% of the dose is excreted unchanged in urine.
Latvian: Neizmainita forma ar urinu izdalas mazak par 1% no devas.
English: Very rare: myositis
Latvian: Loti reti: miozits
English: Dialysis is unlikely to be an efficient method of drug removal due to high protein binding.
Latvian: Nav sagaidams, ka dialize bus efektiva metode preparata izvadišanai, jo tas liela mera ir saistijies pie proteiniem.
English: Caution is also required in patients taking diuretic treatment or otherwise at risk of hypovolaemia.
Latvian: Piesardziba nepieciešama ari tad, ja preparatu lieto pacientiem, kuri sanem diuretisku terapiju vai cita iemesla del paklauti hipovolemijas riskam.
English: Celecoxib inhibits CYP2D6.
Latvian: Celekoksibs inhibe CYP2D6.
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.
Latvian: CYP2D6 substrata individuali noteikto devu var nakties samazinat, kad tiek sakta terapija ar celekoksibu, vai palielinat, ja terapija ar celekoksibu tiek partraukta.
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).
Latvian: Celekoksibs ir diaril-aizvietots pirazola atvasinajums, kas kimiski lidzigs citiem ne-arilaminetiem sulfanilamidiem (piemeram, tiazidiem, furosemidam), bet atškirigs no arilamina grupu saturošiem sulfanilamidiem (piemeram, sulfametoksizola un citiem sulfanilamidiem ar antibakterialu darbibu).
English: Concomitant use of inducers of CYP2C9 such as rifampicin, carbamazepine and barbiturates may reduce plasma concentrations of celecoxib.
Latvian: Lidztekus lietoti CYP2C9 inducetaji, ka rifampicins, karbamazepins un barbiturati, var pazeminat celekoksiba koncentraciju plazma.
English: During celecoxib treatment, the plasma concentrations of the CYP2D6 substrate dextromethorphan were increased by 136%.
Latvian: Celekoksiba terapijas laika CYP2D6 substrata dekstrometorfana koncentracija plazma pieauga par 136%.
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).
Latvian: Lemums par selektivo COX-2 inhibitoru ordinešanu japienem, izvertejot visparejo risku katram pacientam individuali (skatit apakšpunktus 4.3 un 4.4).
English: Celecoxib can be used with low-dose acetylsalicylic acid but is not a substitute for acetylsalicylic acid for cardiovascular prophylaxis.
Latvian: Celekoksibu var lietot ar zemu devu acetilsalicilskabi, bet tas nav acetilsalicilskabes aizstajejs kardiovaskularai profilaksei.
English: Effects of other drugs on celecoxib
Latvian: Citu preparatu ietekme uz celekoksibu
English: Less than 1% of the population are poor metabolisers and have an enzyme with decreased activity.
Latvian: Mazak ka 1% populacijas ir “vaji metabolizetaji”: viniem ir enzims ar pazeminatu aktivitati.
English: - Addition of the contraindications Established ischaemic heart disease and/or cerebrovascular disease and Peripheral arterial disease.
Latvian: - pievienotas kontrindikacijas: Konstateta išemiska sirds slimiba un/vai cerebrovaskulara slimiba un perifero arteriju slimiba.
English: The absolute risk for the composite endpoint was 3.0% for the higher dose of celecoxib, 2.2% for the lower dose of celecoxib, and 0.9% for placebo.
Latvian: Kombineta galamerka absolutais risks bija 3,0% celekoksiba augstakajai devai, 2,2% celekoksiba zemakajai devai un 0,9% placebo.
English: Therefore, antiplatelet therapies should not be discontinued (see section 5.1).
Latvian: Tadel antitrombocitara terapija nav japartrauc (skatit apakšpunktu 5.1).
English: Ramsgate Road Sandwich Kent CT13 9NJ England
Latvian: Ramsgate Road Sandwich Kent CT13 9NJ Anglija
English: Patients with severe hepatic impairment (serum albumin <25 g/l) have not been studied and celecoxib is contraindicated in this patient group.
Latvian: Petijumi ar pacientiem, kuriem ir smaga aknu mazspeja (seruma albumins <25 g/l), nav veikti un celekoksibs šai pacientu grupai ir kontrindicets.
English: 10 DATE OF REVISION OF THE TEXT
Latvian: TEKSTA PEDEJAS PARSKATIŠANAS DATUMS
English: Very rare: angioedema, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, epidermal necrolysis,
Latvian: Loti reti: angioedema, eksfoliatifs dermatits, multiforma eritema, Stivensa-Džonsona sindroms, epidermala nekrolize
English: - Addition of brief information of the CV findings in PreSAP (Efficacy and safety of celecoxib (SC-58635) in the prevention of colorectal sporadic adenomatous polyps) and APC (Prevention of sporadic colorectal adenomas with celecoxib); to include more stringent wording regarding CV risk groups.
Latvian: - pievienota isa informacija par kardiovaskularo iedarbibu, kas ieguta PreSAP petijumos (celecoxib efektivitate un nekaitigums (SC-58635) kolorektalu sporadisku adenomatozu polipu noveršana) un APC petijumos (kolorektalu sporadisku adenomatozu polipu noveršana ar celecoxib); ieklauts obligats formulejums attieciba uz kardiovaskularas iedarbibas riska grupam.
English: Breast feeding (See 4.6 and 5.3).
Latvian: Berna zidišana (skatit apakšpunktus 4.6 un 5.3).
English: - Addition of a warning for patients with risk factors for heart disease, such as hypertension, hyperlipidaemia (high cholesterol levels), diabetes and smoking.
Latvian: - pievienots bridinajums pacientiem ar riska faktoriem saistiba ar sirds slimibam, piemeram, hipertensiju, hiperlipidemiju (augsts holesterina limenis), diabetu un smeketajiem.
English: In an interaction study, celecoxib had no clinically relevant effects on the pharmacokinetics of oral contraceptives (1 mg norethistherone /35 microg ethinylestradiol).
Latvian: Mijiedarbibas petijuma celekoksibam nebija kliniski nozimiga efekta uz iekškigi lietojamo kontraceptivo lidzeklu (1 mg noretisterons/35 mikrogrami etinilestradiols) farmakokinetiku.
English: For excipients, see 6.1.
Latvian: Paligvielas skatit apakšpunktu 6.1.
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.
Latvian: Talak pec Eiropas Komisijas pieprasijuma, parskatamas klases robežas tika paplašinatas, ieklaujot papildus kardiovaskulara nekaitiguma aspektiem ari nopietnas adas reakcijas.
English: History of hypersensitivity to the active substance or to any of the excipients (see 6.1).
Latvian: Anamneze paaugstinats jutigums pret aktivo vielu vai jebkuru no paligvielam (skatit apakšpunktu 6.1).
English: Immune system disorders: Very rare: serious allergic reactions, anaphylactic shock
Latvian: Imunas sistemas traucejumi Loti reti: nopietnas alergiskas reakcijas, anafilaktiskais šoks
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).
Latvian: Pacientus ar nozimigiem kardiovaskulariem riska faktoriem (piemeram, hipertensija, hiperlipidemija, cukura diabets, smekešana) celekoksibu var ordinet tikai pec rupigas apsveršanas (skatit apakšpunktu 5.1).
English: Celecoxib is an oral, selective, cyclooxygenase-2 (COX-2) inhibitor within the clinical dose range (200-400 mg daily).
Latvian: Celekoksibs ir perorali lietojams selektivs ciklooksigenazes-2 (COX-2) inhibitors, ar klinisko devu diapazonu (200-400 mg diena).
English: Based on conventional studies, genotoxicity or carcinogenicity, no special hazard for humans was observed, beyond those addressed in other sections of the SmPC.
Latvian: Balstoties uz konvencialiem petijumiem, genotoksiskumu vai karcinogeno ietekmi, nekads specifisks risks arpus ta, kads minets ši apraksta citas sadalas, cilvekam netika noverots.
English: In vitro studies have shown some potential for celecoxib to inhibit CYP2C19 catalysed metabolism.
Latvian: Petijumos in vitro konstatets, ka celekoksibam piemit zinama speja inhibet CYP2C19 katalizeto metabolismu.
English: In patients with rheumatoid arthritis celecoxib had no statistically significant effect on the pharmacokinetics (plasma or renal clearance) of methotrexate (in rheumatologic doses).
Latvian: Pacientiem ar reimatoido artritu celekoksibs neradija statistiski butisku ietekmi (plazmas vai nieru klirenss) uz metotreksata (lietojot reimatologiskas devas) farmakokinetiku.
English: Kent CT13 9NJ United Kingdom
Latvian: Kent CT13 9NJ
English: Capsule shells contain gelatin, titanium dioxide E171; ink contains iron oxide E172.
Latvian: Kapsulas apvalks satur želatinu, titana dioksidu E171; tinte satur dzelzs oksidu E172. 6.2 Nesaderiba
English: No clinically significant differences were found in PK parameters of celecoxib between elderly African-Americans and Caucasians.
Latvian: Nav noverotas kliniski nozimigas atškiribas celekoksiba farmakokinetiskajos parametros starp gados vecakiem Afro-amerikaniem un baltas rases parstavjiem.
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.]
Latvian: REGISTRACIJAS/PARREGISTRACIJAS DATUMS [Aizpildis registracijas apliecibas ipašnieks ,kad tiks izdarita registracija vai parregistracija]
English: GROUNDS FOR THE AMENDMENT OF THE MARKETING AUTHORISATION
Latvian: PAMATOJUMS PAR GROZIJUMIEM REGISTRACIJAS APLIECIBA
English: Celecoxib is contraindicated in pregnancy and in women who can become pregnant (see 4.3 and 4.4).
Latvian: Celekoksibs ir kontrindicets grutniecibas laika un sievietem, kuram iespejama grutniecibas iestašanas (skatit apakšpunktus 4.3 un 4.4).
English: Norway
Latvian: Norvegija
English: Celecoxib was excreted in rat milk.
Latvian: Celekoksibs izdalijas žurku matišu piena.
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).
Latvian: Divpadsmit nedelu endoskopiskos petijumos celekoksibs (100-800 mg diena) tika saistits ar butiski zemaku gastroduodenalo culu risku salidzinajuma ar naproksenu (1000 mg diena) un ibuprofenu (2400 mg diena).
English: Caution should be exercised when combining celecoxib with warfarin and other oral anticoagulants (See 4.5).
Latvian: Jaievero piesardziba, celekoksibu kombinejot ar varfarinu vai citiem peroraliem antikoagulantiem (skatit apakšpunktu 4.5).
English: Final study reports will be shared with Agencies when available.
Latvian: Kad bus peejami petijuma gala zinojumi tie tiks iesniegti agenturas.
English: In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be considered.
Latvian: Ja arstešana nedod terapeitisku ieguvumu divu nedelu laika, tad ir jaapsver citas terapijas iespejas.
English: Portugal
Latvian: Portugale
English: Ketoconazole or antacids have not been observed to affect the pharmacokinetics of celecoxib.
Latvian: Nav noverots, ka ketokonazols vai antacidie lidzekli ietekmetu celekoksiba farmakokinetiku.
English: Opaque, white with two blue bands marked 7767 and 100 (INVENTED NAME 100 mg).
Latvian: Necaurspidigas, baltas kapsulas ar zilu apmali, uz tam markejums 7767 un 100 (IZGUDROTAIS NOSAUKUMS
English: Several clinical studies have been performed confirming efficacy and safety in osteoarthritis and rheumatoid arthritis.
Latvian: Veikti vairaki kliniskie petijumi, kuri apliecina iedarbigumu un drošumu osteoartrita un reimatoida artrita pacientiem.
English: Very rare: gastrointestinal haemorrhage, acute pancreatitis, colitis/colitis aggravated.
Latvian: Loti reti: gastrointestinala hemoragija, akuts pankreatits, kolits/kolita paasinajums
English: Uncommon: anxiety, depression, tiredness Very rare: confusion, hallucinations.
Latvian: Retak: nemiers, depresija, nogurums Loti reti: apjukums, halucinacijas
English: Patients who experience dizziness, vertigo or somnolence while taking celecoxib should refrain from driving or operating machinery.
Latvian: Pacientiem, kuri celekoksiba lietošanas laika jut apreibumu, reiboni vai miegainibu, jaatturas no transportlidzekla vadišanas vai mehanismu apkalpošanas.
English: No clinical data on exposed pregnancies are available for celecoxib.
Latvian: Nav pieejami nekadi kliniskie dati par ekspoziciju celekoksibam grutniecibas laika.
English: Capsules 100 mg contain lactose monohydrate, sodium lauryl sulphate, povidone K30, croscarmellose sodium and magnesium stearate.
Latvian: 100 mg kapsulas satur laktozes monohidratu, natrija laurilsulfatu, povidonu K30, natrija kroskarmelozi un magnija stearatu.
English: Belgium
Latvian: Belgija
English: 4.5 Interaction with other medicinal products and other forms of interaction
Latvian: 4.5 Mijiedarbiba ar citam zalem un citi mijiedarbibas veidi
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).
Latvian: Perspektiva ilgtermina drošibas petijuma (6 lidz 15 menešu ilgs, CLASS petijums) 5800 osteoartrita un 2200 reimatoida artrita pacienti sanema 400 mg celekoksibu divas reizes diena (4-kartigi un 2-kartigi parsniedz attiecigi osteoartrita un reimatoida artrita ieteicamas devas), ibuprofenu 800 mg tris reizes diena vai diklofenaku 75 mg tris reizes diena (abi terapeitiskajas devas).
English: Those patients on celecoxib and concomitant lowdose acetylsalicylic acid experienced 4 fold higher rates of complicated ulcers as compared to those on celecoxib alone.
Latvian: Tiem pacientiem, kuri lietoja lidztekus celekoksibu un acetilsalicilskabi zema deva, noveroja 4 reizes lielaku komplicetu culu sastopamibu neka tiem, kuri lietoja tikai celekoksibu.
English: In the event of suspected overdose, appropriate supportive medical care should be provided e.g. by eliminating the gastric contents, clinical supervision and, if necessary, the institution of symptomatic treatment.
Latvian: Ja iespejama pardozešana, javeic stavoklim atbilstoši mediciniskie pasakumi, piemeram, kunga satura evakuacija, kliniska noverošana un, ja nepieciešams simptomatiska terapija stacionara.
English: Italy
Latvian: Italija
English: - Addition of a warning for prescribers to consider discontinuation of therapy if during treatment, patients deteriorate in any of the organ system functions described.
Latvian: - pievienots bridinajums zalu izrakstitajiem par nepieciešamibu apsvert arstešanas partraukšanu, ja arstešanas laika pasliktinas pacienta stavoklis attieciba uz kadu no minetajam organu sistemam.
English: To continue to report all ADR frequencies, based on the adverse reaction profile derived from placebo controlled studies, particularly the long-term studies as well as other post marketing experience and make changes to the SPC in accordance with standard Pharmacovigilance reporting and procedures (PSUR, Type II variation within MRP).
Latvian: Turpinat zinot par visu nelabveligo blakusparadibu gadijumiem, pamatojoties uz nelabveligo blakusparadibu profilu, kas ieguts no petijumiem ar placebo kontroli, galvenokart no ilgtermina petijumiem, ka ari no pecregistracijas prakses un jaizdara labojumi zalu apraksta, atbilstoši standarta farmakovigilances zinojumiem un proceduram (PSUR, II.
English: In a two-year toxicity study an increase in nonadrenal thrombosis was observed in male rat at high doses.
Latvian: Divu gadu toksicitates petijuma, lietojot zales lielas devas, žurku teviniem tika noverots neadrenalas trombozes pieaugums.
English: These effects are expected following inhibition of prostaglandin synthesis.
Latvian: Šie efekti ir likumsakarigi ka prostaglandinu sintezes kavejuma sekas.
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.
Latvian: Kombineta galamerka (kardiovaskulara nave, MI vai insults) relativais risks (RR) bija 3,4 (95% ticamibas intervals 1,4-8,5) celekoksiba lielakai devai un 2,5 (95% ticamibas intervals 1,0-6,4) mazakai devai, salidzinajuma ar placebo.
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).
Latvian: Konvencialos embriofetala toksiskuma petijumos konstateta no devas atkariga diafragmalas hernijas attistišanas žurku augliem un kardiovaskularas malformacijas trušu augliem sistemiskas ekspozicijas apstaklos, kas apmeram 5 reizes (žurkam) un 3 reizes (trušiem) parsniedza maksimalo ieteicamo dienas devu cilvekam (400 mg).
English: 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.
Latvian: COX-2 selektivos inhibitorus nevar izmantot acetilsalicilskabes vieta kardiovaskularas trombembolijas profilaksei, jo tiem nepiemit antitrombotiskais efekts.
English: Renal and urinary disorders Very rare: acute renal failure, interstitial nephritis
Latvian: Nieru un urincelu traucejumi Loti reti: akuta nieru mazspeja, intersticials nefrits
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.
Latvian: Uzskaitito blakusparadibu biežums ir vienads vai lielaks par placebo grupa sastopamo blakusparadibu biežumu, del blakusparadibam partrauktas terapijas biežums bija 7,1 % pacientiem, kuri lietoja celekoksibu un 6,1 % pacientu, kuri sanema placebo.
English: Twenty-two percent of enrolled patients took concomitant low-dose acetylsalicylic acid (£325 mg/day),
Latvian: Divdesmit divi procenti ieklauto pacientu lidztekus sanema zemu devu acetilsalicilskabi (=325 mg/diena), galvenokart kardiovaskularai profilaksei.
English: Uncommon: blurred vision, hypertonia, paraesthesia Rare: ataxia, taste alteration
Latvian: Retak: neskaidra redze, hipertonija, parestezija Reti: ataksija, garšas izmainas
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.
Latvian: Atškiribas dažu COX-1 inhibejošo NSPIL un selektivo COX-2 inhibitoru antitrombocitara aktivitate var but kliniski svarigas pacientiem ar trombembolisku komplikaciju risku.
English: § 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.
Latvian: § novertejot: - jaunos datus, kas ieguti par rofecoxib APPROVe kliniskaja petijuma, kura atklajas trombu veidošanas kardiovaskularas paradibas, - datus par celecoxib , kas ieguti APC petijuma, kas lava uzskatit, ka nopietnas kardiovaskularas paradib as ir atkarigas no devas, - datus par valdecoxib un parecoxib, kas ieguti CABG (koronaro arteriju šunta) un CABG II petijumos, kuros noveroja paaugstinatu tromboembolijas gadijumu skaitu parecoxib/valdecoxib lietošanas grupa, salidzinot ar grupu, kura pacienti sanema placebo, - datus par etoricoxib, kas ieguti EDGE petijuma un apvienotajas citu petijumu analizes, kas noradija uz saistibu ar trombu veidošanas risku, kas augstaks neka naproksenam, - datus par lumiracoxib merkpetijuma, kas noradija uz nelielu trombu veidošanas gadijumu skaita palielinašanos (seviški miokarda infarkta gadijumu), salidzinot ar naproksenu,
English: 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).
Latvian: Preliminarie dati no diviem petijumiem, kuros pacienti ar kolorektaliem polipiem, kurus arsteja ar celekoksibu 400 mg diena (skatit apakšpunktu 5.1), miokarda infarkts 3 gados bija 7 gadijumi uz 1000 pacientiem, kas ir vairak neka placebo (Retak).
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.
Latvian: § Papildu zinas nopietnu nelabveligu adas blakusparadibu izvertejumam ir tadas, ka celecoxib ir saistits ar loti retam nopietnam adas reakcijam, par ko liecina kliniskie petijumi un uzraudziba pec registracijas apliecibas izsniegšanas, ka analizes atklaja vairakus riska faktorus šiem nopietniem adas reakciju gadijumiem, ko izraisa celecoxib .
English: Studies in animals (rats and rabbits) have shown reproductive toxicity, including malformations (see 4.3 and 5.3).
Latvian: Petijumos ar dzivniekiem (žurkam un trušiem) konstatets reproduktivs toksiskums, tai skaita malformacijas (skatit apakšpunktus 4.3 un 5.3).
English: Compromised renal or hepatic function and especially cardiac dysfunction are more likely in the elderly and therefore medically appropriate supervision should be maintained.
Latvian: Nieru vai aknu un ipaši sirds funkciju ierobežojums biežak ir gados vecakiem cilvekiem, un mineto iemeslu del nepieciešama pienaciga mediciniska uzraudziba.