FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose is 500 mg at intervals of one month, with an additional 500 mg dose given two weeks after the initial dose.
Latvian: Pieaugušām sievietēm (tostarp gados vecākām sievietēm) Ieteicamā deva ir 500 mg ik pēc viena mēneša ar papildu 500 mg devas ievadīšanu divas nedēļas pēc sākotnējās devas.
English: Fulvestrant has been shown to cross the placenta after single intramuscular doses in rat and rabbit.
Latvian: Ir pierādīts, ka pēc vienreizējas intramuskulāras devas ievadīšanas žurkām un trušiem fulvestrants šķērso placentas barjeru.
English: In the pooled dataset of fulvestrant monotherapy, the most frequently reported adverse reactions were injection site reactions, asthenia, nausea, and increased hepatic enzymes (ALT, AST, ALP).
Latvian: Apvienotos datos par fulvestranta monoterapiju visbiežāk novērotās nevēlamās blakusparādības bija reakcijas injekcijas vietā, astēnija, slikta dūša un paaugstināts aknu enzīmu līmenis (ALAT, ASAT, sārmainā fosfatāze).
English: e Anaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased.
Latvian: e Leikopēniju aprakstošie IT ir “anēmija”, “pazemināts hemoglobīna līmenis” un “samazināts hematokrīts”.
English: Comparison between groups (Fulvestrant 500 mg/ Fulvestrant 250 mg) Hazard ratio
Latvian: Grupu salīdzinājums (Fulvestrants 500 mg/fulvestrants 250 mg) Riska attiecība 95% TI p vērtība
English: How to store Fulvestrant Mylan 6.
Latvian: Kā uzglabāt Fulvestrant Mylan
English: c Neutropenia includes the following PTs: Neutropenia, Neutrophil count decreased.
Latvian: c Neitropēniju aprakstošie IT ir “neitropēnija” un “samazināts neitrofilo leikocītu skaits”.
English: Progression-Free Survival Median [months (95% CI)] Hazard ratio (95% CI) and p-value
Latvian: Dzīvildze bez slimības progresēšanas Mediāna [mēneši (95% TI)] Riska attiecība (95% TI) un p vērtība
English: OSb
Latvian: KIB
English: Figure 1 Kaplan-Meier Plot of Progression-Free Survival (Investigator Assessment, Intent-To-Treat Population) ─ FALCON Study
Latvian: Kaplana-Meiera diagramma, kas atspoguļo pētījumā FALCON novēroto dzīvildzi bez slimības progresēšanas saskaņā ar pētnieka vērtējumu attiecībā uz ārstējamo populāciju
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.
Latvian: To fulvestranta grupas pacienšu apakšgrupā (n = 208), kuru slimība izpaudās ar ne-viscerālām metastāzēm, RA bija 0,592 (95% TI 0,419-0,837; salīdzinājumā ar anastrozola grupu).
English: Progression-Free Survival Number of PFS Events (%) PFS Hazard Ratio (95% CI) and pvalue
Latvian: Dzīvildze bez slimības progresēšanas DzBP gadījumu skaits (%) DzBP riska attiecība (95% TI) un p vērtība
English: No dose adjustments are recommended for patients with mild to moderate hepatic impairment.
Latvian: Pacientiem ar viegliem līdz vidēji smagiem aknu darbības traucējumiem devas pielāgošana netiek ieteikta.
English: Fulvestrant + placebo (N=172)
Latvian: Fulvestrants + placebo (n = 172)
English: Fulvestrant plus placebo (N=105)
Latvian: Fulvestrants + placebo (N = 105)
English: Benzyl benzoate Benzyl alcohol Ethanol, anhydrous Castor oil, refined
Latvian: Benzilbenzoāts Benzilspirts Etilspirts, bezūdens Rīcineļļa, attīrīta
English: • Joint and musculoskeletal pain
Latvian: • Locītavu un skeleta muskuļu sāpes.
English: PFS:Progression-free survival; ORR:Objective response rate; OR:Objective response; CBR:Clinical benefit rate; CB:Clinical benefit; OS:Overall survival; K-M:Kaplan-Meier; CI:Confidence interval; AI:Aromatase inhibitor; AE:Anti-estrogen.
Latvian: TI: ticamības intervāls; AI: aromatāzes inhibitors; AE: antiestrogēns.
English: Figure 2 Kaplan-Meier plot of progression-free survival (investigator assessment, intentto-treat population) - PALOMA3 study
Latvian: Kaplana-Meiera diagramma, kas raksturo pētījumā PALOMA-3 novēroto dzīvildzi bez slimības progresēšanas saskaņā ar pētnieka vērtējumu par ārstēto populāciju
English: Vomiting, diarrhoea
Latvian: Etilspirts, bezūdens
English: Fulvestrant plus placebo (N=69)
Latvian: Fulvestrants + placebo (N = 69)
English: Secondary end points* OR [% (95% CI)] OR (measurable disease) [% (95% CI)]
Latvian: OR [% ( 95% TI)] OR (kvantitatīvi raksturojamas slimības gadījumos) [% (95% TI)] DOR (kvantitatīvi raksturojamas slimības gadījumos) [mēneši (95% TI)]
English: The term injection site reactions does not include the terms injection site haemorrhage, injection site haematoma, sciatica, neuralgia and neuropathy peripheral.
Latvian: b Uz reakcijām injekcijas vietā netiek attiecinātas hemorāģijas un hematomas injekcijas vietā, sēžas nerva iekaisums, neiralģija un perifēra neiropātija.
English: Fulvestrant plus placebo (N=174)
Latvian: Fulvestrants + placebo (N = 174)
English: Fulvestrant Mylan 250 mg solution for injection in prefilled syringe fulvestrant
Latvian: Fulvestrant Mylan 250 mg šķīdums injekcijām pilnšļircē fulvestrantum
English: This medicine contains 500 mg benzyl alcohol in each 5 ml.
Latvian: Šīs zāles satur 500 mg benzilspirta katros 5 ml. Benzilspirts var izraisīt alerģiskas reakcijas.
English: Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with fulvestrant injection.
Latvian: Saistībā ar fulvestranta injekcijām ir ziņots par reakcijām injekcijas vietā, tostarp par sēžas nerva iekaisumu, neiralģiju, neiropātiskām sāpēm un perifēru neiropātiju.
English: e
Latvian: AI
English: Two syringes must be administered to receive the 500 mg recommended monthly dose.
Latvian: Lai saņemtu ieteikto mēneša devu 500 mg, jāievada divas šļirces.
English: N=number of patients; CI=confidence interval; NE=not estimable; OR=objective response; CBR=clinical benefit response; DOR=duration of response
Latvian: NA - nav aprēķināms; OR - objektīva reakcija; KIB - klīniskā ieguvuma biežums;
English: Includes adverse drug reactions for which the exact contribution of fulvestrant cannot be assessed due to the underlying disease.
Latvian: Hemorāģija injekcijas vietāf, hematoma injekcijas vietāf, neiralģijac a Ietver blakusparādības, kurām tiešu saistību ar fulvestrantu nevar novērtēt pamatslimības dēļ.
English: g Stomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration,
Latvian: h Izsitumus aprakstošie IT ir “izsitumi”, “makulopapulāri izsitumi”, “niezoši izsitumi”, “eritematozi izsitumi”,
English: This medicinal product contains 500 mg benzyl alcohol in each 5 ml.
Latvian: Fulvestrant Mylan satur benzilspirtu Šīs zāles satur 500 mg benzilspirta katros 5 ml.
English: NAME OF THE MEDICINAL PRODUCT Fulvestrant Mylan 250 mg solution for injection in prefilled syringe
Latvian: ZĀĻU NOSAUKUMS Fulvestrant Mylan 250 mg šķīdums injekcijām pilnšļircē
English: Absolute difference in
Latvian: Mainīgais lielums
English: After
Latvian: vai
English: Stomatitisg Diarrhoea Vomiting Skin and subcutaneous tissue disorders Very common Alopecia Rashh Common Dry skin General disorders and administration site conditions Very common Fatigue Pyrexia Common Asthenia Investigations Common AST increased ALT increased
Latvian: Disgeizija Acu bojājumi Bieži Pastiprināta asarošana Redzes miglošanās Acu sausums Elpošanas sistēmas traucējumi, krūšu kurvja un videnes slimības Bieži Deguna asiņošana Kuņģa-zarnu trakta traucējumi Ļoti bieži Slikta dūša Stomatītsg Caureja Vemšana Ādas un zemādas audu bojājumi Ļoti bieži Alopēcija Izsitumih Bieži Ādas sausums Vispārēji traucējumi un reakcijas ievadīšanas vietā Ļoti bieži Nespēks Pireksija Bieži Astēnija Izmeklējumi Bieži Paaugstināts AsAT līmenis Paaugstināts AlAT līmenis
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution
Latvian: NOSAUKUMS(-I) UN DAUDZUMS(-I) Viena pilnšļirce satur 250 mg fulvestranta 5 ml šķīdumā.
English: DOR (measurable disease) [months (95% CI)]
Latvian: DzBP mediāna [mēneši (95% TI)]
English: Fulvestrant showed effects upon reproduction and embryo/foetal development consistent with its anti-estrogenic activity, at doses similar to the clinical dose.
Latvian: Lietojot klīniskai devai līdzīgu devu, fulvestranta ietekme uz vairošanos un embrija/augļa attīstību atbilda tā pretestrogēnu iedarbībai.
English: Patients were well matched for baseline demographics and prognostic characteristics between the fulvestrant plus palbociclib arm and the fulvestrant plus placebo arm.
Latvian: Fulvestranta un palbocikliba kombinācijas un fulvestranta un placebo kombinācijas grupas pacientes pēc demogrāfiskajiem un prognostiskajiem rādītājiem bija ļoti līdzīgas.
English: f Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased.
Latvian: d Leikopēniju aprakstošie IT ir “leikopēnija” un “samazināts leikocītu skaits”.
English: Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis.
Latvian: g Stomatītu aprakstošie IT ir “aftozs stomatīts”, “heilīts”, “glosīts”, “glosodīnija”, “čūlas mutē”, “gļotādu iekaisums”, “sāpes mutē”, “diskomforts mutē un rīklē”, “sāpes mutē un rīklē” un “stomatīts”.
English: Vaginal haemorrhagee
Latvian: Kuņģa-zarnu trakta traucējumi
English: Number of patients at risk
Latvian: Pacientēm ar kvantitatīvi raksturojamu slimību
English: Combined analysis of both studies showed the hazard ratio of fulvestrant 250 mg to anastrozole for progression-free survival was
Latvian: Kombinēta abu pētījumu analīze liecina, ka riska attiecība fulvestrantam 250 mg un anastrozolam attiecībā uz dzīvildzi bez progresēšanas bija 0,95 (95% TI 0,82-1,10).
English: System Organ Class Frequency Preferred Terma
Latvian: Orgānu sistēma Biežums
English: PFS
Latvian: Ltd.
English: What you need to know before you use Fulvestrant Mylan 3.
Latvian: Kas ir Fulvestrant Mylan un kādam nolūkam to lieto Kas Jums jāzina pirms Fulvestrant Mylan lietošanas Kā lietot Fulvestrant Mylan Iespējamās blakusparādības Kā uzglabāt Fulvestrant Mylan Iepakojuma saturs un cita informācija
English: The text was valid at that time.
Latvian: Tolaik šis teksts bija speka.
English: This USR was initiated on 16 February 2005 and finalised on 17 February 2005.
Latvian: Darbs pie USR tika uzsakts 2005. gada 16. februari un pabeigts 2005. gada 17. februari.
English: Elimination half-life is 8-12 hours.
Latvian: Pusizvadišanas periods ir 8-12 stundas.
English: Corporation Representation Office in Lithuania A. Gostauto 40 a
Latvian: P. Corporation Representation Office in Lithuania A. Gostauto 40 a
English: This information will be updated as final data become available.
Latvian: Ši informacija tiks papildinata tiklidz bus pieejami gala rezultati.
English: LT-01112 Vilnius Lithuania
Latvian: LT-01112 Vilnius Lietuva
English: Pack of 2, 5, 6, 10, 20, 30, 40, 50, 60, 100, 10x10, 10x30, 10x50, 1x50 unit dose, 1x100 unit dose.
Latvian: Iepakojuma 2, 6, 10, 20, 30, 40, 50, 60, 100, 10x10, 10x30, 10x50, 1x50, 1x100 kapsulas.
English: Rare: alopecia, photosensitivity
Latvian: Reti: alopecija, fotosensitivitate
English: On 23 June 2005, the CHMP concluded that:
Latvian: 2005. gada 23. junija CHMP secinaja, ka,
English: 1324 Lysaker Norway
Latvian: 1324 Lysaker Norvegija
English: 183 25 Täby Sweden
Latvian: 183 25 Täby Zviedrija
English: The plasma concentration of celecoxib is approximately 100% increased in elderly women (>65 years).
Latvian: Celekoksiba koncentracija plazma ir palielinata par aptuveni 100 % gados vecakam sievietem (>65 gadi).
English: Lagoas Park, Edifício n.º 10 2740-244 Porto Salvo Portugal
Latvian: Lagoas Park, Edifício n.º 10 2740-244 Porto Salvo Portugale
English: 1515 Lefkosia Cyprus
Latvian: 1515 Lefkosia Kipra
English: Corporation Eesti Pirita tee 20
Latvian: P. Corporation Eesti Pirita tee 20
English: Via Robert Koch, 1-2 20152 Milano Italy
Latvian: Via Robert Koch, 1 -2 20152 Milano Italija
English: Milton Keynes MK5 8PH United Kingdom
Latvian: Milton Keynes MK5 8PH Lielbritanija
English: There is a genetic polymorphism of this enzyme.
Latvian: Šim enzimam piemit genetisks polimorfisms.
English: Pharmacotherapeutic group: ATC code: M01AH01.
Latvian: Farmakoterapeitiska grupa: ATK kods - M01AH01.
English: MOM Park ”F” Épület H-1123 Budapest
Latvian: Alkotás utca 53. MOM Park ”F” Épület H-1123 Budapest
English: Avenida de Europa, 20-B Parque Empresarial La Moraleja 28108 Alcobendas, Madrid Spain
Latvian: Avenida de Europa, 20-B Parque Empresarial La Moraleja 28108 Alcobendas, Madrid Spanija
English: Therefore, this SPC may not necessarily represent the current text.
Latvian: Tadel šim SPC nav obligati jaatspogulo pašreizejais teksts.
English: (See 4.3, 4.4 and 5.2).
Latvian: 4.3.,4.4.un 5.2.)
English: Patients with estimated creatinine clearance <30 ml/min.
Latvian: Pacienti, kuriem konstatets kreatinina klirens <30 ml/min.
English: Pfizer Luxembourg SARL, 283, route d'Arlon, L-8011 Strassen, Luksemburg
Latvian: Pfizer Luxembourg SARL, 283, route d'Arlon, L-8011 Strassen, Luksemburga
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)]
Latvian: Loti bieži (>1/10), bieži (>1/100, <1/10), retak (>1/1000, <1/100), reti (>1/10000, <1/1000), loti reti (<1/10000, ieskaitot atseviškus gadijumus).
English: Rivium Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands
Latvian: Rivium Westlaan 142 2909 LD Capelle a/d IJssel Niderlande
English: During the CHMP meeting of February 2005, discussions on cardiovascular safety took place.
Latvian: CHMP 2005. gada februara sedes laika notika diskusijas par kardiovaskularo drošibu.
English: Nervous system disorders
Latvian: Nervu sistemas traucejumi
English: 76139 Karlsruhe Germany
Latvian: 76139 Karlsruhe Vacija
English: Pfizer Hellas A. E. 5, Alketou Street 116 33 Athens Greece
Latvian: Pfizer Hellas A. E. 5, Alketou Street 116 33 Athens Griekija
English: Congestive heart failure (NYHA II-IV).
Latvian: Sastreguma sirds mazspeja (NYHA II-IV).
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.]
Latvian: Valsts nosaukums, telefona Nr., faksa numurs, e-mail adrese]
English: Plasma protein binding is about 97% at therapeutic plasma concentrations and the drug is not preferentially bound to erythrocytes.
Latvian: Saistišanas ar plazmas olbaltumvielam pie terapeitiskam koncentracijam plazma ir ap 97%, un medikaments netiek parsvara piesaistits pie eritrocitiem.
English: Capsule, hard.
Latvian: Cietas kapsulas.
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.
Latvian: Iesniegt spontano zinojumu analizi par visam nopietnam adas reakcijam, kas ieguta izanalizejot RegiSCAR datu bazi un ar preses sekretaru turpmak apspriest rezultatu iesniegšanu.
English: To continue to make available emerging clinical and epidemiological data through publications and, where possible, in scientific congresses.
Latvian: Turpinat sniegt pieejamos kliniskos un epidemiologiskos datus, proti, ka publikacijas un, ja iespejams, zinatniskajos kongresos.
English: 4.1 Therapeutic indications
Latvian: 4.1 Terapeitiskas indikacijas
English: Active peptic ulceration or gastrointestinal (GI) bleeding.
Latvian: Aktiva peptiska ulceracija vai gastrointestinala (GI) asinošana.
English: 4.7 Effects on ability to drive and use machines
Latvian: 4.7 Ietekme uz speju vadit transportlidzeklus un apkalpot mehanismus
English: 4.3 Contraindications
Latvian: 4.3 Kontrindikacijas
English: Approximately 7400 patients were treated with celecoxib in controlled trials and of those approximately 2300 have received it for 1 year or longer.
Latvian: Kontroletos petijumos aptuveni 7400 pacientu tikuši arsteti ar celekoksibu un no tiem aptuveni 2300 to lietojuši 1 gadu vai ilgak.
English: To provide final study reports for the following long-term trials APC/PreSAP/ADAPT in full, when available.
Latvian: Kad ir pieejami, iesniegt pilnu petijuma gala zinojumu, par attiecigiem APC/Pre-SAP/ADAPT ilgtermina petijumiem.
English: Pfizer Europe MA EEIG Ramsgate Road Sandwich
Latvian: Slovakijas republika Pfizer Europe MA EEIG Ramsgate Road
English: Two isoforms, COX-1 and COX-2, have been identified.
Latvian: Identificetas divas ta izoformas, COX-1 un COX-2.
English: Steady state plasma concentrations are reached within 5 days of treatment.
Latvian: Vienmerigas koncentracijas limenis plazma tiek sasniegts 5 terapijas dienu laika.
English: {Invented Name}100 mg and 200 mg capsules contain lactose (149.7 mg and 49.8 mg, respectively).
Latvian: {Izgudrotais nosaukums} 100 mg un 200 mg kapsulas satur laktozi (attiecigi 149,7 mg un 49,8 mg).
English: The clinical significance of this in vitro finding is unknown.
Latvian: Šis in vitro atrades kliniska nozime nav zinama.
English: Although it is not a strong inhibitor of this enzyme, a dose reduction may be necessary for individually dose-titrated drugs that are metabolised by CYP2D6 (See 4.5).
Latvian: Lai gan tas nav specigs ši enzima inhibitors, tomer var rasties nepieciešamiba reducet individuali pielagoto devu preparatiem, kurus metabolize CYP2D6 (skatit apakšpunktu 4.5).
English: In pregnancy and in women of childbearing potential unless using an effective method of contraception (See 4.5).
Latvian: Grutnieciba un sievietes, kuram var iestaties grutnieciba, ja vien tas nelieto efektivu kontracepcijas metodi (skatit apakšpunktu 4.5).
English: The main metabolites found in the circulation have no detectable COX-1 or COX-2 activity.
Latvian: Galvenajiem asinsrite atrodamiem metabolitiem nekada konstatejama COX-1 vai COX-2 aktivitate nepiemit.
English: Dosing with food (high fat meal) delays absorption by about 1 hour.
Latvian: Preparata ienemšana kopa ar uzturu (treknas maltites laika) palenina ta absorbciju par apmeram 1 stundu.
English: The dose may, if needed, later be increased to 200 mg twice daily.
Latvian: Ja nepieciešama, devu velak var palielinat lidz 200 mg divas reizes diena.
English: Furthermore, the MAH commits to continue dialogue with EMEA/CHMP with regard to study design
Latvian: Turklat, MAH apnemas turpinat parrunas ar EMEA/CHMP par petijuma dizainu.
English: The data were inconsistent in comparison with diclofenac (150 mg per day).
Latvian: Dati salidzinajuma ar diklofenaku (150 mg diena) bija pretrunigi.
English: Lab. Medinfar - Produtos Farmacêuticos S.A. R. Manuel Ribeiro de Pavia, n.º1 - Venda Nova 2700-547 Amadora
Latvian: R. Manuel Ribeiro de Pavia, n.º1 - Venda Nova 2700-547 Amadora
English: Where full study reports are not available to the MAH, it agrees to provide publications/manuscripts in lieu of the study report(s).
Latvian: Ja MAH nav pieejams viss petijuma zinojums, ta vieta, tas piekrit iesniegt petijuma zinojuma(u) publikacijas/manuskriptus.
English: The CHMP agreed that an Urgent Safety Restriction (USR) on cardiovascular safety was needed to introduce new contraindications and strengthen warnings and information on side effects in the SPC.
Latvian: CHMP apstiprinaja, ka no kardiovaskulara nekaitiguma viedokla ir nepieciešams steidzams drošibas ierobežojums (USR), lai ieviestu jaunas kontrindikacijas un pastiprinatu bridinajumus un informaciju par zalu apraksta.
English: Czech Republic
Latvian: Cehijas republika
English: 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg or 200 mg celecoxib.
Latvian: KVALITATIVAIS UN KVANTITATIVAIS SASTAVS Katra kapsula satur 100 mg vai 200 mg celekoksiba (Celecoxibum).
English: Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ³10).
Latvian: Smaga aknu slimiba (seruma albumins <25 g/l vai Child-Pugh >10).
English: The following events have been reported in patients receiving celecoxib in 12 placebo and/or active controlled trials.
Latvian: Sekojošas blakusparadibas zinotas no pacientiem, kuri lietojuši celekoksibu 12 placebo un/vai aktivi kontroletos petijumos.
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
Latvian: PIELIKUMS I ZALU NOSAUKUMU, FORMU, STIPRUMU, LIETOŠANAS VEIDA, DALIBVALSTU, NORVEGIJAS UN ISLANDES REGISTRACIJAS APLIECIBAS IPAŠNIEKU SARAKSTS
English: Known hypersensitivity to sulphonamides.
Latvian: Zinama paaugstinata jutiba pret sulfanilamidiem.
English: Celecoxib is well absorbed reaching peak plasma concentrations after approximately 2-3 hours.
Latvian: Celekoksibs labi uzsucas, maksimalo koncentraciju plazma sasniedzot pec apmeram 2-3 stundam.
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.
Latvian: 2005. gada 7. aprili Zalu un partikas parvalde (FDA) un EMEA pieprasija Pfizer brivpratigi atsaukt Bextra (valdecoxib) no tirgus, un Pfizer piekrita apturet Bextra tirdzniecibu un marketingu visa pasaule, kamer, sakara ar datiem par nopietnam adas reakcijam notiek talaka nelabveligas riska/ieguvuma attiecibas apspriešana.
English: Women who take celecoxib should not breastfeed.
Latvian: Sievietes, kuras lieto celekoksibu, nedrikst zidit bernu.
English: ANNEX IV CONDITIONS OF THE MARKETING AUTHORISATION
Latvian: PIELIKUMS IV REGISTRACIJAS APLIECIBAS IPAŠNIEKA NOSACIJUMI
English: On 20 April 2005, Pfizer presented data on serious skin reactions for valdecoxib during a hearing.
Latvian: 2005. gada 20. aprili, jautajuma izskatišanas laika, Pfizer ie sniedza datus par valdecoxib izraisitam, nopietnam adas reakcijam.
English: The phase I metabolism is mainly catalysed by CYP2C9.
Latvian: I fazes metabolismu katalize galvenokart CYP 2C9.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
Latvian: II PIELIKUMS ZINATNISKIE SLEDZIENI UN PAMATOJUMS ZALU APRAKSTA IZMAINAM, KO IESNIEGUSI EIROPAS ZALU AGENTURA (EMEA)
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.
Latvian: PIELIKUMS III ZALU APRAKSTS Piezime: Šis SPC tika pievienots ka Komisijas direktivas pielikums atsaucei uz 31 pantu attieciba uz celekoksiba saturošam zalem.
English: In some patients, with insufficient relief from symptoms, an increased dose of 200 mg twice daily may increase efficacy.
Latvian: Dažiem pacientiem ar nepietiekošu simptomu zudumu devas palielinašana 200 mg divas reizes diena var paaugstinat terapijas efektivitati.
English: The corresponding values in patients with moderate hepatic impairment were 41% and 146% respectively.
Latvian: Salidzinošie raditaji pacientiem ar merenu aknu bojajumu bija attiecigi 41 % un 146 %.
English: Clear or opaque PVC blisters or aluminium cold-formed blisters.
Latvian: Gaiši vai gaismas necaurlaidigi PVH blisteri vai aluminija aukstumizturigi blisteri.
English: Celecoxib is mainly eliminated by metabolism.
Latvian: Celekoksiba eliminacija galvenokart notiek, tam metabolizejoties.
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).
Latvian: COX-2 iesaistas ari ovulacijas, implantacijas un ductus arteriosus slegšanas procesos, ta piedalas nieru darbibas kontrole un centralas nervu sistemas funkcijas (induce drudzi, nodrošina sapju percepciju un kognitivo funkciju).
English: oC.
Latvian: (Sk.