FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT DULOXETINE BOEHRINGER INGELHEIM 30 mg hard gastro-resistant capsules
Bulgarian: DULOXETINE BOEHRINGER INGELHEIM30 mg твърди стомашно-устойчиви капсули
English: Talk to your doctor before you take the medicine if you:
Bulgarian: Вашия лекар преди да приемете този лекарствен продукт.
English: • bad breath
Bulgarian: Стоматит Лош дъх от устата
English: Vertigo Ear pain Respiratory, thoracic and mediastinal disorders Yawning
Bulgarian: Респираторни, гръдни и медиастинални нарушения Прозяване
English: Chest pain
Bulgarian: Коремна болка
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 60 mg of duloxetine (as hydrochloride)
Bulgarian: Всяка капсула съдържа 60 mg дулоксетин (като хидрохлорид)
English: Ejaculation disorder Ejaculation delayed Sexual
Bulgarian: Стомашно-чревни нарушения Гадене
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 60 mg of duloxetine (as hydrochloride).
Bulgarian: Всяка капсула съдържа 60 mg дулоксетин (duloxetine) (като хидрохлорид).
English: Mydriasis
Bulgarian: ПРИТЕЖАТЕЛ
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 60 mg hard gastro-resistant capsules
Bulgarian: НА 60 MG СТОМАШНО-УСТОЙЧИВИ КАПСУЛИ, ТВЪРДИ
English: Stomatitis Breath odour Haematochezia
Bulgarian: Нарушение на съня Бруксизъм Дезориентаци я
English: Tél: +33 3 26 50 45 33
Bulgarian: Boehringer Ingelheim France S.A.S. Tél: +33 3 26 50 45 33
English: Muscle twitching
Bulgarian: Мускулно напрежение
English: If you forget to take DULOXETINE BOEHRINGER INGELHEIM If you miss a dose, take it as soon as you remember.
Bulgarian: Ако пропуснете някоя доза, приемете я веднага щом се сетите.
English: It was to be available as tablets (125 mg and 250 mg).
Bulgarian: Трябвало е да се предлага под формата на таблетки (125 mg и 250 mg).
English: The main measure of effectiveness is the number of patients who respond to treatment.
Bulgarian: Основната мярка за ефективност е броят на пациентите, които се повлияват от лечението.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Bulgarian: Ако участвате в клинично изпитване или в програма за милосърдна цел и се нуждаете от повече информация за Вашето лечение, свържете се с лекаря, който Ви го е предписал.
English: In addition, QT prolongation (a change in the heart's electrical activity) and cases of serious heart problems presented a safety concern.
Bulgarian: Освен това удължаването на QT интервала (промяна в електрическата активност на сърцето) и случаите на тежки сърдечни проблеми създават опасение за безопасността.
English: The data provided were too limited to enable evaluation of the effectiveness of Xegafri at this time.
Bulgarian: Предоставените данни са твърде ограничени, за да позволят оценка на ефективността на Xegafri към този момент.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 May 2016
Bulgarian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 май 2016 г.
English: In these studies, Xegafri is not compared with any other treatment.
Bulgarian: В тези проучвания Xegafri не е сравнен с друго лечение.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing its application because of a revised business strategy for the product.
Bulgarian: В писмото, с което фирмата уведомява Агенцията за оттеглянето на заявлението, се посочва, че заявлението се оттегля поради ревизирана бизнес стратегия за продукта.
English: The company informed the CHMP that they will stop enrolling patients in the ongoing clinical trials.
Bulgarian: Фирмата уведоми СНМР, че ще спре да включва пациенти в текущите клинични проучвания.
English: What is Xegafri?
Bulgarian: Какво представлява Xegafri?
English: The company will continue to provide Xegafri to patients whose doctor recommend they should continue to take this medicine.
Bulgarian: Фирмата ще продължи да предоставя Xegafri на пациенти, чийто лекар препоръчва да продължат да приемат това лекарство.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Xegafri did not outweigh its risks.
Bulgarian: Поради това към момента на оттеглянето становището на CHMP е, че ползите от Xegafri не превишават рисковете.
English: Xegafri is a medicine that contains the active substance rociletinib.
Bulgarian: Xegafri е лекарство, което съдържа активното вещество роцилетиниб (rociletinib).
English: By blocking the tyrosine kinase in EGFR, rociletinib is expected to help reduce the growth and spread of the cancer.
Bulgarian: Като блокира тирозин киназите в EGFR, роцилетиниб се очаква да помогне за намаляването на растежа и разпространението на рака.
English: In lung cancer cells, EGFR is often overactive, causing uncontrolled division of cancer cells.
Bulgarian: При белодробните ракови клетки EGFR често е свръхактивен, което води до неконтролируемо делене на раковите клетки.
English: In addition, patients currently receiving Xegafri through a compassionate use programme can continue to receive this medicine.
Bulgarian: Освен това пациентите, които в момента получават Xegafri в рамките на програма с милосърдна цел, могат да продължат да получават това лекарство.
English: Withdrawal of the marketing authorisation application for Xegafri (rociletinib)
Bulgarian: Оттегляне на заявлението за разрешаване за употреба на Xegafri (rociletinib)
English: The active substance in Xegafri, rociletinib, is a tyrosine kinase inhibitor.
Bulgarian: Активното вещество в Xegafri, роцилетиниб, е тирозин киназен инхибитор.
English: Unlike most other tyrosine kinase inhibitors, rociletinib targets cancer cells with the T790M mutation in the EGFR gene.
Bulgarian: За разлика от повечето други тирозин киназни инхибитори, роцилетиниб е насочен срещу ракови клетки с мутация T790M в гена EGFR.
English: Xegafri was to be used to treat a type of lung cancer called non-small cell lung cancer (NSCLC) in adults who have the T790M mutation (a particular change in the gene for a protein called epidermal growth factor receptor or EGFR) and who had already been treated with EGFR-targeted therapy.
Bulgarian: Xegafri е трябвало да се използва за лечение на вид рак на белия дроб, наречен недребноклетъчен рак на белия дроб (НДРБД), при възрастни, които имат мутацията Т790М (специфична промяна в гена за протеин, наречен рецептор на епидермалния растежен фактор или EGFR), и които вече са били лекувани с анти-EGFR терапия.
English: How is Xegafri expected to work?
Bulgarian: Как се очаква да действа Xegafri?
English: Based on the review of the data, at the time of the withdrawal, the CHMP had had some concerns and was of the provisional opinion that Xegafri could not have been approved for the treatment of NSCLC patients who have the T790M mutation.
Bulgarian: Въз основа на прегледа на данните, към момента на оттеглянето CHMP има известни забележки и изразява предварително становище, че Xegafri не може да бъде одобрен за лечение на пациенти с НДРБД, които имат мутацията Т790М.
English: Xegafri is being investigated in two studies in 457 NSCLC patients who have the T790M mutation and had already been treated with EGFR-targeted therapy.
Bulgarian: Xegafri е изследван в две проучвания при 457 пациенти с НДРБД, които имат Т790М мутация и които вече са били лекувани с анти-EGFR терапия.
English: What was Xegafri expected to be used for?
Bulgarian: За какво се очаква да се използва Xegafri?
English: This means that it blocks the activity of enzymes known as tyrosine kinases, particularly tyrosine kinases that are present in EGFRs.
Bulgarian: Това означава, че блокира активността на ензими, наречени тирозин кинази, по-конкретно на тирозин кинази, които участват в EGFR. EGFR контролира растежа и делението на клетките.
English: On 3 May 2016, Clovis Oncology UK Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Xegafri, for the treatment of non-small cell lung cancer.
Bulgarian: Комитета по лекарствените продукти за хуманна употреба (CHMP), че желае да оттегли заявлението си за разрешaване за употреба на Xegafri, показан за лечение на недребноклетъчен рак на белия дроб.
English: 1 ml (100 mg/ml) 2 (2 x 1) pre-filled syringes (multipack)
Bulgarian: 1 ml (100 mg/ml) 2 (2 x 1) предварително напълнени спринцовки (групова опаковка)
English: 1 ml (100 mg/ml) 2 (2 x 1) pre-filled pens (multipack)
Bulgarian: 1 ml (100 mg/ml) 2 (2 x 1) предварително напълнени писалки (групова опаковка)
English: 2 pre-filled syringes + 2 safety needles
Bulgarian: 2 предварително напълнени спринцовки + 2 обезопасени игли
English: 1 pre-filled syringe + 1 safety needle
Bulgarian: 1 предварително напълнена спринцовка + 1 обезопасена игла
English: The absolute risk increase for such events is unlikely to exceed 1% per year based on existing data (uncommon).
Bulgarian: Den absolutte økende risiko for slike hendelser overskrider sannsynligvis ikke 1% per år basert på eksisterende data (uvanlig).
English: Therefore, the combination should be administered with caution, especially in the elderly.
Bulgarian: Derfor bør kombinasjonen brukes med forsiktighet spesielt hos eldre.
English: Five metabolites have been identified in man.
Bulgarian: Fem metabolitter er identifisert hos mennesker.
English: Children and adolescents under 16 years of age.
Bulgarian: Barn og ungdom under 16 år.
English: The absolute bioavailability is approximately 100%.
Bulgarian: Absolutt biotilgjengelighet er ca.
English: 3 years.
Bulgarian: 2 år
English: These data are not considered clinically significant.
Bulgarian: Disse dataene anses ikke å være klinisk signifikante.
English: Not applicable.
Bulgarian: Ikke relevant.
English: The clinical relevance of these observations has not been established.
Bulgarian: Klinisk relevans av disse observasjonene er ikke fastslått.
English: Doses greater than those recommended for each indication have either not demonstrated additional efficacy or have not been studied.
Bulgarian: Høyere doser enn de som er anbefalt for hver enkelt indikasjon, har enten ikke gitt tilleggseffekt eller er ikke studert.
English: If blood pressure rises significantly, alternative treatment should be considered.
Bulgarian: Hvis blodtrykket øker vesentlig, skal alternativ behandling vurderes.
English: Elderly: Pharmacokinetics in the elderly (65 years of age and older) are similar to those in the young.
Bulgarian: Eldre: Farmakokinetikken hos eldre (65 år og eldre) ligner den hos yngre.
English: Renal prostaglandins may play a compensatory role in the maintenance of renal perfusion.
Bulgarian: Renale prostaglandiner kan spille en kompensatorisk rolle i opprettholdelsen av renal perfusjon.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Bulgarian: Studier i dyr har vist reproduksjonstoksisitet (se 5.3).
English: Safety
Bulgarian: Sikkerheten
English: None of these metabolites inhibit COX-1.
Bulgarian: Ingen av disse metabolittene hemmer COX-1.
English: • You are a woman trying to become pregnant.
Bulgarian: som planlegger å bli gravide.
English: No dosage adjustment is necessary for elderly patients.
Bulgarian: Eldre: Ingen dosejustering er nødvendig for eldre pasienter.
English: [Very Common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000), not known (cannot be estimated from the available data)]
Bulgarian: [Svært vanlige (>1/10), Vanlige (> 1/100, < 1/10) Mindre vanlige (>1/1000, < 1/100), Sjeldne (>1/10,000, <1/1000), Svært sjeldne (<1/10,000) inkludert isolerte tilfeller]
English: The rate of absorption was affected, resulting in a 36% decrease in Cmax and an increase in Tmax by 2 hours.
Bulgarian: , noe som resulterte i 36 % reduksjon i Cmax og en økning av Tmax med 2 timer.
English: Investigations:
Bulgarian: Undersøkelser:
English: Common: hypertension.
Bulgarian: Vanlig: hypertensjon.
English: The potential for human risk in pregnancy is unknown.
Bulgarian: svangerskap hos mennesker er ukjent.
English: Less than 2% was recovered as unchanged drug.
Bulgarian: Mindre enn 2% ble gjenfunnet
English: Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10).
Bulgarian: Alvorlig leverdysfunksjon (serum-albumin <25 g/l eller Child-Pugh score ≥10).
English: Driving and using machines
Bulgarian: til å kjøre bil eller bruke maskiner
English: Very rare: peptic ulcers including gastrointestinal perforation and bleeding (mainly in the elderly).
Bulgarian: Svært sjeldne: peptisk sår inkludert gastrointestinal perforasjon og blødning (hovedsakelig hos eldre).
English: If necessary, monitor blood lithium closely and adjust the lithium dosage while the combination is being taken and when the NSAID is withdrawn.
Bulgarian: Hvis nødvendig, overvåk konsentrasjonen av litium i blodet nøye, og juster litiumdosen justeres når kombinasjonen tas og når NSAID seponeres.
English: Estimated renal creatinine clearance <30 ml/min.
Bulgarian: Beregnet kreatininclearance <30 ml/min.
English: In dogs, renal and gastrointestinal abnormalities were seen at high exposures.
Bulgarian: Hos hunder ble renale og gastrointestinale uregelmessigheter sett ved høy eksponering.
English: Very rare: urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Bulgarian: Svært sjeldne: urtikaria, Stevens-Johnson syndrom, toksisk epidermal nekrolyse.
English: Active peptic ulceration or active gastro-intestinal (GI) bleeding.
Bulgarian: Aktivt magesår eller aktiv gastrointestinal (GI) blødning.
English: Very rare: renal insufficiency, including renal failure, usually reversible upon discontinuation of treatment (see section 4.4).
Bulgarian: Svært sjeldne: nedsatt nyrefunksjon, inkludert nyresvikt, vanligvis reversibel når behandlingen stoppes (se 4.4).
English: Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.
Bulgarian: Pasientene bør være adekvat hydrert og monitorering av nyrefunksjonen bør vurderes ved start av ledsagende behandling og deretter periodisk.
English: Immune system disorder:
Bulgarian: Forstyrrelser i immunsystemet:
English: Renal effects
Bulgarian: Renale effekter
English: Etoricoxib is an inhibitor of human sulfotransferase activity, particularly SULT1E1, and has been shown to increase the serum concentrations of ethinyl estradiol.
Bulgarian: Etorikoksib er en hemmer av human sulfotransferaseaktivitet, særlig SULT1E1, og har vist å øke serumkonsentrasjonen av etinyløstradiol.
English: Very rare: bronchospasm.
Bulgarian: Svært sjeldne: bronkospasmer.
English: There are no clinical or pharmacokinetic data in patients with severe hepatic dysfunction (Child-Pugh score ≥10).
Bulgarian: Det finnes ingen kliniske eller farmakokinetiske data for pasienter med sterkt nedsatt leverfunksjon (Child-Pugh score ≥10).
English: However, patients at high risk of digoxin toxicity should be monitored for this when etoricoxib and digoxin are administered concomitantly.
Bulgarian: Pasienter med høy risiko for digoksintoksisitet bør imidlertid overvåkes for dette når etorikoksib og digoksin gis samtidig.
English: Gastrointestinal effects
Bulgarian: Gastrointestinale effekter
English: Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
Bulgarian: Etablert iskemisk hjertesykdom, perifer arteriesykdom og/eller cerebrovaskulær sykdom.
English: The effect of the recommended chronic doses of etoricoxib (30, 60, and 90 mg) has not been studied.
Bulgarian: Effekten av anbefalte kroniske doser for etorikoksib (60 og 90 mg) er ikke studert.
English: CYP3A4 appears to contribute to the metabolism of etoricoxib in vivo.
Bulgarian: CYP3A4 ser ut til å medvirke i metabolismen av etorikoksib in vivo.
English: The geometric mean area under the curve (AUC0-24hr) was 37.8 µg•hr/ml.
Bulgarian: Geometrisk middelverdi for arealet under kurven (AUC0-24timer) var 37,8 µg•
English: 4.3 Contra-indications
Bulgarian: 4.3 Kontraindikasjoner
English: Etoricoxib had a higher incidence of ulceration as compared to placebo.
Bulgarian: Etorikoksib hadde høyere insidens av ulcerasjon sammenlignet med placebo.
English: Etoricoxib at 60 and 90 mg had no effect on methotrexate plasma concentrations or renal clearance.
Bulgarian: Etorikoksibdoser på 60 og 90 mg hadde ingen effekt på plasmakonsentrasjoner av metotreksat eller renal clearance.
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 effect.
Bulgarian: Selektive COX-2-hemmere kan ikke erstatte acetylsalisylsyre til profylakse mot kardiovaskulære trombo-emboliske sykdommer, på grunn av deres manglende platehemmende effekt
English: Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with etoricoxib after careful consideration (see section 5.1).
Bulgarian: Pasienter med vesentlige risikofaktorer for kardiovaskulære hendelser (f. eks hypertensjon, hyperlipidemi, diabetes mellitus, røyking)skal kun behandles med etorikoksib etter nøye vurdering (se
English: Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.
Bulgarian: Litium: NSAIDs reduserer utskillelsen av litium fra nyrene og øker derfor plasmanivået av litium.
English: Common: dizziness, headache.
Bulgarian: Vanlige: svimmelhet, hodepine.
English: These principal metabolites either demonstrate no measurable activity or are only weakly active as COX-2 inhibitors.
Bulgarian: ingen målbar aktivitet eller er bare svakt aktive som COX-2-hemmere.
English: Prednisone/prednisolone: In drug-interaction studies, etoricoxib did not have clinically important effects on the pharmacokinetics of prednisone/prednisolone.
Bulgarian: Prednison/prednisolon: I medikamentelle interaksjonsstudier har etorikoksib ikke vist noen klinisk relevante effekter på farmakokinetikken til prednison/prednisolon.
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).
Bulgarian: Beslutningen om å forskrive en selektiv COX-2-hemmer skal bygge på en vurdering av den enkelte pasients samlede risiko (se pkt.
English: Elimination of etoricoxib occurs almost exclusively through metabolism followed by renal excretion.
Bulgarian: Eliminasjon av etorikoksib foregår hovedsakelig ved metabolisering fulgt av renal utskillelse.
English: Etoricoxib crosses the placenta in rats and rabbits, and the blood-brain barrier in rats.
Bulgarian: 120 liter hos mennesker. Etorikoksib passerer placenta hos rotter og kaniner og blod-hjerne-barrieren hos rotter.
English: Dosing with food (a high-fat meal) had no effect on the extent of absorption of etoricoxib after administration of a 120-mg dose.
Bulgarian: Dosering med mat (fettrikt måltid) hadde ingen effekt på graden av absorpsjon av etorikoksib etter administrasjon av 120 mg dose.
English: If during treatment, patients deteriorate in any of the organ system functions described above, appropriate measures should be taken and discontinuation of etoricoxib therapy should be considered.
Bulgarian: Dersom pasienten blir verre under behandlingen med tanke på funksjonen i noen av organsystemene beskrevet ovenfor,skal nødvendige tiltak iverksettes og seponering av behandlingen med etorikoksib
English: These beneficial effects were observed as early as the second day of therapy and maintained for up to 52 weeks.
Bulgarian: så tidlig som den andre behandlingsdagen og varte i opptil 52 uker.
English: These increases in estrogenic concentration should be taken into consideration when selecting post-menopausal hormone therapy for use with etoricoxib because the increase in oestrogen exposure might increase the risk of adverse events associated with HRT.
Bulgarian: til denne økningen i østrogenkonsentrasjonen når man velger hormoner ved behandling av menopausen ved samtidig bruk av etorikoksib, da økningen i eksponering av østrogen kan øke risikoen for bivirkninger forbundet med hormonbehandling.
English: Hepatic effects
Bulgarian: Hepatiske effekter
English: Following administration of a single 25-mg radiolabeled intravenous dose of etoricoxib to healthy subjects, 70% of radioactivity was recovered in urine and 20% in faeces, mostly as metabolites.
Bulgarian: Etter administrering av en intravenøs enkeltdose på 25 mg radiomerket etorikoksib til friske personer, ble 70% av radioaktiviteten gjenfunnet i urinen og 20% i feces, mesteparten
English: (See sections 4.2 and 4.3.)
Bulgarian: (Se 4.2 og 4.3).
English: Pain relief was observed as early as four hours after initiation of treatment.
Bulgarian: så tidlig som fire timer etter behandlingsstart.
English: Absorption
Bulgarian: Absorpsjon
English: The principal metabolite is the 6'-carboxylic acid derivative of etoricoxib formed by further oxidation of the 6'-hydroxymethyl derivative.
Bulgarian: Hovedmetabolittene er 6'-karboksylsyrederivat av etorikoksib dannet ved videre oksidering av 6'-hydroksymetylderivatet.
English: <Etoricoxib> is administered orally and may be taken with or without food.
Bulgarian: Dosering og administrasjonsmåte <INVENTED NAME> gis oralt og kan tas med eller uten mat.
English: * Based on analyses of long-term placebo and active controlled clinical trials, selective COX-2 inhibitors have been associated with an increased risk of serious thrombotic arterial events, including myocardial infarction and stroke.
Bulgarian: Basert på analyser av placebo og aktivt kontrollerte langtidsstudier har selektive COX-2 hemmere blitt assosiert med en økende risiko for trombotiske arterielle hendelser inkludert hjerteinfarkt og slag.
English: In clinical studies, the undesirable effects profile was similar in patients with OA or RA treated with etoricoxib for one year or longer.
Bulgarian: I kliniske studier var bivirkningsprofilen liknende for OA- og RA-pasienter, som ble behandlet med etorikoksib i ett år eller lenger.
English: Cardiovascular effects
Bulgarian: Kardiovaskulære effekter
English: Pregnancy and lactation (see sections 4.6 and 5.3).
Bulgarian: Graviditet og amming (se 4.6 og 5.3 ).
English: There is a further increase in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal complications) when etoricoxib is taken concomitantly with acetylsalicylic acid (even at low doses).
Bulgarian: Det er en ytterligere økt risiko for gastrointestinale bivirkninger(gastrointestinal sårdannelse eller andre gastrointestinale komplikasjoner), når etorikoksib brukes samtidig med acetylsalisylsyre (selv ved lave doser). En signifikant forskjell i gastrointestinal
English: Etoricoxib is contraindicated in pregnancy (see section 4.3).
Bulgarian: Etorikoksib er kontraindisert under svangerskapet (se 4.3).
English: In one study, etoricoxib 120 mg had no effect, but in the other study, etoricoxib 120 mg increased methotrexate plasma concentrations by 28% and reduced renal clearance of methotrexate by 13%.
Bulgarian: I én studie hadde ikke etorikoksib 120 mg noen virkning, men i den andre studien førte etorikoksib 120 mg til 28% økning i plasmakonsentrasjon av metotreksat og 13% reduksjon i renal clearance av metotreksat.
English: In the rat, gastrointestinal toxicity of etoricoxib increased with dose and exposure time.
Bulgarian: Hos rotter økte gastrointestinal toksisitet av etorikoksib med dose og eksponeringstid.
English: This should be considered when rapid symptomatic relief is needed.
Bulgarian: Når rask symptomatisk behandling er nødvendig bør dette tas hensyn til.
English: Adequate monitoring for methotrexate-related toxicity is recommended when etoricoxib and methotrexate are administered concomitantly.
Bulgarian: Adekvat monitorering med hensyn på metotreksatrelatert toksisitet er anbefalt, når etorikoksib gis samtidig med metotreksat.
English: The volume of distribution at steady state (Vdss) was approximately 120 l in humans.
Bulgarian: Distribusjonsvolumet ved steady-state (Vdss) var ca.