FrancophonIA/ELRC3.0 huggingface dataset:
English: DULOXETINE BOEHRINGER INGELHEIM should not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Danish: DULOXETINE BOEHRINGER INGELHEIM bør ikke gives til patienter med nedsat leverfunktion på grund af leversygdom (se pkt.
English: The usual dose of DULOXETINE BOEHRINGER INGELHEIM is 1 capsule (60 mg) once a day, but your doctor will prescribe the dose that is right for you.
Danish: Den anbefalede dosis af DULOXETIN BOEHRINGER INGELHEIM er 1 kapsel (60 mg) én gang daglig.
English: BEFORE YOU TAKE DULOXETINE BOEHRINGER INGELHEIM
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE DULOXETIN BOEHRINGER INGELHEIM
English: Hepatic impairment
Danish: Letargi Smags
English: inability to sleep), feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), tremor (shakiness), headaches, feeling irritable, diarrhoea, excessive sweating or vertigo.
Danish: • svimmelhed, prikkende følelse som når noget sover, søvnforstyrrelse (livagtige drømme, mareridt, søvnløshed), rastløshed eller uro, angst, kvalme eller opkastning, rystelser, hovedpine, irritation, diaré, forøget tendens til at svede eller svimmelhed.
English: • decreased thyroid gland activity
Danish: • nedsat aktivitet af skjoldbruskkirtlen
English: PHARMACEUTICAL FORM AND CONTENTS 7 hard gastro-resistant capsules, 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 28 hårde enterokapsler
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/471/011-012
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/471/011-012
English: Urinary Retention Dysuria Urinary hesitation Nocturia Polyuria Urine flow decreased
Danish: Besværet vandladning Natlig vandladning Nedsat urinmængde
English: Agitation
Danish: Palpitationer
English: Do not take more than the daily amount of DULOXETINE BOEHRINGER INGELHEIM that has been prescribed for you in one day.
Danish: Du må ikke tage mere DULOXETIN BOEHRINGER INGELHEIM pr. dag, end lægen har ordineret.
English: In an open label long-term uncontrolled study, the pain reduction in patients responding to 8-weeks of acute treatment of DULOXETINE BOEHRINGER INGELHEIM 60 mg once daily was maintained for a further 6-months as measured by change on the Brief Pain Inventory(BPI) 24-hour average pain item.
Danish: Hos de patienter, som responderede på 8-ugers akut behandling med 60 mg ARICLAIM en gang daglig i et open-label, langtids, ukontrolleret forsøg, holdt smertereduktionen i yderligere 6 måneder.
English: No dosage adjustment is recommended for elderly patients solely on the basis of age.
Danish: Man bør ikke reducere dosis ved behandling af ældre patienter udelukkende på grund af alder. Der bør dog udvises forsigtighed ved behandling af ældre (se pkt.
English: • contraction of the jaw muscle
Danish: • sammentrækning af kæbemusklen
English: Monoamine Oxidase Inhibitors (MAOIs): You should not take DULOXETINE BOEHRINGER INGELHEIM if you are taking, or have recently taken within the last 14 days, another antidepressant medicine called a monoamine oxidase inhibitor (MAOI).
Danish: Monoaminoxidasehæmmere (MAO-hæmmere): Du må ikke tage DULOXETIN BOEHRINGER INGELHEIM sammen med en MAO-hæmmer eller inden for 14 dage efter afsluttet behandling med en MAO-hæmmer.
English: • having abnormal urine odour
Danish: • unormal urinlugt
English: Sodium Lauryl Sulfate Titanium Dioxide (E171) Indigo Carmine (E132) Edible Green Ink
Danish: 30 mg: Gelatine, natriumlaurilsulfat, titandioxid (E171), indigotin (E132) og Edible Green Ink.
English: − are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacine which are used to treat some infections
Danish: (monoaminoxidasehæmmer) (se afsnittet nedenfor: "Brug af anden medicin") - tager fluvoxamin (til behandling af bl.a. depression), ciprofloxacin eller enoxacin (til behandling af infektioner)
English: Psychiatric Disorders Insomnia
Danish: Psykiske forstyrrelser Søvnløshed Uro
English: • lack of appetite, weight loss
Danish: • øget tendens til at gabe • nedsat appetit, vægttab
English: Always take DULOXETINE BOEHRINGER INGELHEIM exactly as your doctor has told you.
Danish: Hvis du skal tage DULOXETINE BOEHRINGER INGELHEIM, vil din læge sige det til dig.
English: DULOXETINE BOEHRINGER INGELHEIM contains sucrose.
Danish: DULOXETINE BOEHRINGER INGELHEIM enterokapsler indeholder saccharose.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 30 mg of duloxetine (as hydrochloride)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 30 mg duloxetin (som hydrochlorid).
English: What DULOXETINE BOEHRINGER INGELHEIM contains The active substance is duloxetine.
Danish: DULOXETIN BOEHRINGER INGELHEIM indeholder: - Aktivt stof:
English: It may harm them, even if their symptoms are the same as yours - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Danish: - Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: Edible Green Ink contains: Black Iron Oxide-Synthetic (E172) Yellow Iron Oxide- Synthetic (E172) Propylene glycol
Danish: Edible Green Ink indeholder: Syntetisk sort jernoxid (E172), syntetisk gul jernoxid (E172), propylenglycol og Shellac.
English: Blurred vision Mydriasis Visual disturbance
Danish: Mydriasis Synsforstyrrelser
English: Feeling hot Gait disturbance
Danish: Kuldegysninger Generel utilpashed Varmefølelse Gangforstyrrelser
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 60 mg of duloxetine (as hydrochloride)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 60 mg duloxetin (som hydrochlorid).
English: DULOXETINE BOEHRINGER INGELHEIM gastro-resistant capsules contain sucrose.
Danish: DULOXETINE BOEHRINGER INGELHEIM-enterokapsler indeholder saccharose.
English: NAME OF THE MEDICINAL PRODUCT DULOXETINE BOEHRINGER INGELHEIM 30 mg, hard gastro-resistant capsules.
Danish: LÆGEMIDLETS NAVN DULOXETINE BOEHRINGER INGELHEIM 30 mg hårde enterokapsler.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/471/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/471/003
English: Serotonin syndrome
Danish: Serotoninsyndrom Ekstrapyramidale symptomer Akatisi
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/471/011
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/471/011
English: Edible White Ink contains: Titanium Dioxide (E171) Propylene glycol Shellac
Danish: Edible White Ink indeholder: Titandioxid (E171), propylenglycol, Shellac og povidon.
English: What DULOXETINE BOEHRINGER INGELHEIM is and what it is used for Before you take DULOXETINE BOEHRINGER INGELHEIM How to take DULOXETINE BOEHRINGER INGELHEIM Possible side effects
Danish: Det skal du vide, før du begynder at tage DULOXETIN BOEHRINGER INGELHEIM Sådan skal du tage DULOXETIN BOEHRINGER INGELHEIM Bivirkninger
English: • are breast-feeding.
Danish: • brystsmerter.
English: NAME OF THE MEDICINAL PRODUCT DULOXETINE BOEHRINGER INGELHEIM 60 mg hard gastro-resistant capsules
Danish: LÆGEMIDLETS NAVN DULOXETINE BOEHRINGER INGELHEIM 60 mg hårde enterokapsler
English: LIST OF EXCIPIENTS Contains sucrose See leaflet for further information
Danish: LISTE OVER HJÆLPESTOFFER Indeholder saccharose.
English: Sodium Lauryl Sulfate Titanium Dioxide (E171) Indigo Carmine (E132) Yellow Iron Oxide (E172) Edible White Ink
Danish: 60 mg: Gelatine, natriumlaurilsulfat, titandioxid (E171), indigotin (E132), gul jernoxid (E172) og Edible White Ink.
English: Breast feeding
Danish: Forstoppelse Diaré
English: • feeling the heart pumping in the chest, flushing, increased sweating, night sweats
Danish: • hjertebanken, hedeture, svedtendens, nattesved
English: Muscle
Danish: Muskelsitren
English: DO NOT take DULOXETINE BOEHRINGER INGELHEIM if you:
Danish: Du bør ikke bruge DULOXETIN BOEHRINGER INGELHEIM, mens du ammer.
English: Ejaculation disorder Ejaculation delayed Sexual
Danish: Problemer med udløsning Forsinket udløsning Seksuel dysfunktion Gynækologisk blødning
English: Use in children and adolescents under 18 years of age No clinical trials have been conducted with duloxetine in paediatric populations.
Danish: Der er ikke foretaget nogen kliniske forsøg med duloxetin på børn.
English: Tremor Paraesthesia
Danish: Somnolens Svimmelhed
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT Not applicable.
Danish: Lægemidlet er receptpligtigt.
English: behaviour
Danish: Epistaxis
English: • chest pain
Danish: • (kløende) udslæt
English: Titanium dioxide (E171) Triethyl citrate.
Danish: Titandioxid (E171)
English: • vertigo, ear pain
Danish: Vertigo Ørepine
English: HOW TO STORE DULOXETINE BOEHRINGER INGELHEIM Keep out of the reach and sight of children
Danish: Der er ingen erfaring med brug af DULOXETINE BOEHRINGER INGELHEIM hos børn og unge (se pkt.
English: Sugar spheres
Danish: Rysten Paræstesier
English: Apathy
Danish: Gastritis
English: PACKAGE LEAFLET: INFORMATION FOR THE USER DULOXETINE BOEHRINGER INGELHEIM 30 mg hard gastro-resistant capsules DULOXETINE BOEHRINGER INGELHEIM 60 mg hard gastro-resistant capsules Duloxetine (as hydrochloride)
Danish: DULOXETIN BOEHRINGER INGELHEIM 30 mg hårde enterokapsler DULOXETIN BOEHRINGER INGELHEIM 60 mg hårde enterokapsler
English: NAME OF THE MEDICINAL PRODUCT DULOXETINE BOEHRINGER INGELHEIM 30 mg hard gastro-resistant capsules Duloxetine
Danish: DULOXETINE BOEHRINGER INGELHEIM 30 mg hårde enterokapsler Duloxetin
English: NAME OF THE MEDICINAL PRODUCT DULOXETINE BOEHRINGER INGELHEIM 60 mg hard gastro-resistant capsules Duloxetine
Danish: DULOXETINE BOEHRINGER INGELHEIM 60 mg hårde enterokapsler Duloxetin
English: Very Rare Frequency not known
Danish: Meget sjælden
English: − have severe kidney disease are taking or have recently taken within the last 14 days, another antidepressant medicine called a monoamine oxidase inhibitor (MAOI) (see also below in section: ‘Taking other medicines')
Danish: - tager anden medicin til behandling af depression (se ”Brug af anden medicin”) - tager et naturlægemiddel eller kosttilskud, der indeholder perikon (Hypericum perforatum) - har en nyresygdom.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg of duloxetine (as hydrochloride) Excipients: sucrose 8.6 mg.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver kapsel indeholder 30 mg duloxetin (som hydrochlorid).
English: • menopausal symptoms
Danish: • symptomer på overgangsalder
English: Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 69 50 50 83 09
Danish: KG Tel: +49 (0) 69 50 50 83 09
English: Dizziness attention Lethargy Dysgeusia Dyskinesia Restless legs syndrome sleep symptoms Akathisia Psychomotor restlessness
Danish: Letargi forstyrrelse Dyskinesi Uro i benene Dårlig søvnkvalitet
English: Renal and Urinary Disorders
Danish: kolinerge og adrenerge receptorer.
English: Haemorrhage
Danish: Dysuri
English: Renal insufficiency
Danish: Nyreinsufficiens:
English: • burping, indigestion, gastroenteritis
Danish: • bøvsen, fordøjelsesbesvær eller mavekatar
English: It was to be available as tablets (125 mg and 250 mg).
Danish: Det var hensigten, at det skulle leveres som tabletter (125 mg og 250 mg).
English: The main measure of effectiveness is the number of patients who respond to treatment.
Danish: Det vigtigste mål for behandlingens virkning er den andel af patienterne, hos hvem behandlingen virker.
English: EGFR controls growth and division of cells.
Danish: EGFR kontrollerer cellers vækst og deling.
English: What is Xegafri?
Danish: Hvad er Xegafri?
English: In these studies, Xegafri is not compared with any other treatment.
Danish: I disse undersøgelser bliver Xegafri ikke sammenlignet med nogen anden behandling.
English: EMA/352428/2016 EMEA/H/C/004053
Danish: Den 27. maj 2016 EMA/352428/2016 EMEA/H/C/004053
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.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at tilbagetrækningen skyldtes, at forretningsstrategien for produktet var ændret.
English: The company informed the CHMP that they will stop enrolling patients in the ongoing clinical trials.
Danish: Virksomheden har til CHMP oplyst, at den vil ophøre med at indrullere patienter i de igangværende kliniske undersøgelser.
English: The company will continue to provide Xegafri to patients whose doctor recommend they should continue to take this medicine.
Danish: Virksomheden vil fortsat udlevere Xegafri til patienter, hvis læge anbefaler, at de skal fortsætte med at tage lægemidlet.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 May 2016
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Xegafri is a medicine that contains the active substance rociletinib.
Danish: Xegafri er et lægemiddel, der indeholder det aktive stof rociletinib.
English: In addition, QT prolongation (a change in the heart's electrical activity) and cases of serious heart problems presented a safety concern.
Danish: Desuden var der et sikkerhedsproblem i form af QT-forlængelse (en ændring i hjertets elektriske aktivitet) og beskrevne tilfælde af alvorlige hjerteproblemer.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Xegafri did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Xegafri ikke opvejede risiciene.
English: The data provided were too limited to enable evaluation of the effectiveness of Xegafri at this time.
Danish: De forelagte data var for begrænsede til at muliggøre vurdering af effektiviteten på dette tidspunkt.
English: In lung cancer cells, EGFR is often overactive, causing uncontrolled division of cancer cells.
Danish: I lungekræftceller er EGFR ofte overaktiv, så kræftcellerne deler sig ukontrolleret.
English: Withdrawal of the marketing authorisation application for Xegafri (rociletinib) EMA/352428/2016
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Xegafri (rociletinib) EMA/352428/2016
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.
Danish: Den 3. maj 2016 meddelte Clovis Oncology UK Ltd officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om markedsføringstilladelse for Xegafri til behandling af ikke-småcellet lungekræft.
English: What was Xegafri expected to be used for?
Danish: Hvad forventedes Xegafri anvendt til?
English: Withdrawal of the marketing authorisation application for Xegafri (rociletinib)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Xegafri (rociletinib)
English: By blocking the tyrosine kinase in EGFR, rociletinib is expected to help reduce the growth and spread of the cancer.
Danish: Ved at blokere tyrosinkinase i EGFR forventes rociletinib at hæmme kræftens vækst og spredning.
English: How is Xegafri expected to work?
Danish: Hvordan forventes Xegafri at virke?
English: In addition, patients currently receiving Xegafri through a compassionate use programme can continue to receive this medicine.
Danish: De patienter, der på nuværende tidspunkt får Xegafri som led i et program med særlig udleveringstilladelse, kan desuden fortsætte med at få lægemidlet.
English: The active substance in Xegafri, rociletinib, is a tyrosine kinase inhibitor.
Danish: Det aktive stof i Xegafri, rociletinib, er en tyrosinkinasehæmmer.
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.
Danish: På baggrund af gennemgangen af de data, der forelå på tidspunktet for tilbagetrækningen af ansøgningen, havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Xegafri ikke kunne være blevet godkendt til behandling af NSCLC-patienter, som har T790M-mutationen.
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.
Danish: Xegafri forventedes anvendt til behandling af en type lungekræft, der kaldes ikke-småcellet lungekræft (NSCLC) hos voksne, som har T790M-mutationen (en særlig ændring i genet for proteinet epidermal vækstfaktorreceptor eller EGFR), og som i forvejen allerede har fået behandling rettet mod EGFR.
English: This means that it blocks the activity of enzymes known as tyrosine kinases, particularly tyrosine kinases that are present in EGFRs.
Danish: Det vil sige, at stoffet blokerer virkningen af enzymer af typen tyrosinkinaser, herunder de tyrosinkinaser, der findes i EGFR.
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.
Danish: Xegafri er ved at blive undersøgt i to undersøgelser hos 457 patienter, der har NSCLC og har T790M mutationen og i forvejen har fået behandling rettet mod EGFR.
English: Unlike most other tyrosine kinase inhibitors, rociletinib targets cancer cells with the T790M mutation in the EGFR gene.
Danish: I modsætning til de fleste andre tyrosinkinasehæmmere er dette aktive stof aktivt mod kræftceller med mutationen T790M i genet for EGFR.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Xegafri eller i programmer for anvendelse af Xegafri med særlig udleveringstilladelse?
English: 1 ml (100 mg/ml) 2 (2 x 1) pre-filled pens (multipack)
Danish: 1 ml (100 mg/ml) 2 (2 x 1) fyldte penne (multipakning)
English: 1 ml (100 mg/ml) 1 pre-filled pen
Danish: 1 ml (100 mg/ml)
English: 1 ml (100 mg/ml) 2 (2 x 1) pre-filled syringes (multipack)
Danish: 2 (2 x 1) fyldte injektionssprøjter (multipakning)
English: Route of Administration
Danish: opløsning
English: 2 pre-filled syringes + 2 safety needles
Danish: 2 fyldte injektionssprøjter + 2 beskyttede kanyler
English: 1 pre-filled syringe + 1 safety needle
Danish: 1 fyldt injektionssprøjte + 1 beskyttet kanyle
English: 3 years.
Danish: 2 år.
English: D-85540 Haar
Danish: 85540 Haar
English: 1000 Ljubljana Slovenia
Danish: SI-1000 Ljubljana Slovenien
English: No dosage adjustment is necessary for elderly patients.
Danish: Ældre Justering af dosis er ikke nødvendig til ældre patienter.
English: Use of gastroprotective agents and low dose aspirin were permitted in the studies.
Danish: Brug af gastrobeskyttende midler og lavdosis aspirin var tilladt i undersøgelsen.
English: 00191 Roma
Danish: I-00191 Roma
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)]
Danish: [Meget almindelig (>1/10), Almindelig (> 1/100, < 1/10), Ikke-almindelig (> 1/1000, < 1/100), Sjælden (> 1/10.000, < 1/1000), Meget sjælden (< 1/10.000) inklusiv enkeltstående rapporter]
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRINGEN AF PRODUKTRESUMEET FREMLAGT AF EMEA
English: Riga, LV-1013
Danish: LV-1013 Riga
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJ OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE OG NORGE OG ISLAND
English: Via G. Fabbroni 6 00191 Roma Italy
Danish: Via G. Fabbroni, 6 I-00191 Roma Italien
English: COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Danish: COX-2 er isoformen af det enzym, som induceres af proinflammatoriske stimuli, og som man mener hovedsagelig har ansvaret for syntesen af prostanoide mediatorer for smerte, inflammation og feber.
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).
Danish: Patienter med særlige risikofaktorer for kardiovaskulære hændelser (f.eks. hypertension, hyperlipidæmi, diabetes mellitus og rygning) bør kun behandles med etoricoxib efter nøje overvejelse (se afsnit 5.1).
English: The clinical significance of these increases is unknown, and higher doses of PREMARIN were not studied in combination with etoricoxib.
Danish: Den kliniske signifikans af disse stigninger er ukendt og højere doser af Premarin, givet i kombination med etoricoxib, er ikke undersøgt.
English: Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
Danish: Konstateret iskæmisk hjertesygdom, perifer arteriel sygdom og/eller cerebrovaskulær sygdom
English: DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION [To be completed nationally.]
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Måned dag, år
English: No dosage adjustment is necessary for patients with creatinine clearance ≥30 ml/min (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med creatininclearance ≥30 ml/min (se afsnit 5.2 ).
English: An increase in EE exposure can increase the incidence of adverse events associated with oral contraceptives (e.g., venous thrombo-embolic events in women at risk).
Danish: En øgning i EØ eksponering kan øge bivirkningsfrekvensen i forbindelse med oral antikonception (f.eks. venøse thromboemboliske tilfælde hos kvinder i risikogruppen).
English: 00-867 Warsaw Poland
Danish: 02-785 Warszawa Polen
English: Women who use etoricoxib must not breast feed (see sections 4.3 and 5.3).
Danish: Kvinder der tager etoricoxib bør ikke amme (se afsnit 4.3 og 5.3).
English: The effect of the recommended chronic doses of etoricoxib (30, 60, and 90 mg) has not been studied.
Danish: Effekten af de anbefalede doser ved kronisk behandling med etoricoxib (60 mg og 90 mg), er ikke undersøgt.
English: Estimated renal creatinine clearance <30 ml/min.
Danish: Anslået creatininclearance < 30 ml/min
English: There was no discernible difference in the rate of confirmed serious thrombotic cardiovascular events between patients receiving etoricoxib ≥60 mg, placebo, or nonnaproxen NSAIDs.
Danish: Der var ingen mærkbar forskel i incidensen af alvorlige thrombotiske kardiovaskulære hændelser hos patienter der fik etoricoxib ≥ 60 mg, placebo eller non-naproxen NSAID.
English: The onset of the effect of the medicinal product may be faster when <Etoricoxib> is administered without food.
Danish: Virkningen af lægemidlet kan indtræde hurtigere når <SÆRNAVN> administreres uden mad.
English: Selective COX-2 inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
Danish: COX-2 selektive hæmmere reducerer dannelsen af systemiske (og dermed muligvis endotel-deriveret) prostacyclin uden at påvirke thromboxan i blodpladerne.
English: Laboratorios Abello, S.A. Josefa Valcárcel, 38 28027 Madrid Spain
Danish: Laboratorios Abello c/ Josefa Valcarcel 38 28027 Madrid Spanien
English: What is rheumatoid arthritis?
Danish: Rheumatoid arthritis
English: Av. da Siderurgia Nacional S. Mamede do Coronado Portugal
Danish: Da Siderurgia Nacional, 4745-457 S. Mamede do Coronado Portugal