FrancophonIA/ELRC3.0 huggingface dataset:
English: Reduced blood flow in the heart vessels, faster heartbeat - Bleeding, partial or complete blocking of blood vessels, reduced blood pressure - Shortness in breath, disorders of the respiratory tissues in the lung, collection of liquid around the lung, inflammation of the pharynx, cough, flu-like symptoms Stomach problems such as inflammation or ulcer causing abdominal pain or diarrhoea, bleeding in the stomach, inflammation or ulcer in the mouth, collection of fluid in the belly, vomiting, abdominal pain, indigestion, constipation, passing wind, bloating, loose stools - Bile duct disorders, yellowing of the skin due to liver problems, liver tissue damage and inflammation of the liver
Danish: mavesmerter, fordøjelsesbesvær, forstoppelse, luftafgang fra tarmen, oppustethed, løs afføring - Galdegangssygdomme, gulsot, ødelæggelse af levervæv og leverbetændelse - Kløe, udslæt, hårtab, akne, svedudbrud - Smerter i led, lemmer, ryg og fødder, muskelspasmer - Utilstrækkelig nyrefunktion, nedsat urindannelse, forringet eller smertefuld vandladning - Generel svaghed, feber, væskeansamling i kroppen, smerter og ubehag, øget indhold af basisk fosfatase i blodet, vægtstigning, ændret opfattelse af kropstemperatur - Utilstrækkelig funktion af det transplanterede organ
English: Advagraf 5 mg prolonged-release hard capsules Tacrolimus
Danish: Advagraf 5 mg depotkapsler, hårde Tacrolimus
English: Advagraf 5 mg prolonged-release hard capsules EU/1/07/387/007
Danish: Advagraf 5 mg depotkapsler, hårde EU/1/07/387/007
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON Advagraf 3 mg prolonged-release hard capsules
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON Advagraf 3 mg depotkapsler, hårde
English: Itching, rash, hair loss, acne, increased sweating
Danish: udslæt, pruritus, alopeci, akne, svedudbrud
English: Each capsule contains 3 mg tacrolimus (as monohydrate).
Danish: Hver kapsel indeholder 3 mg tacrolimus (som monohydrat).
English: Gelatin capsules imprinted in red with “5 mg” on the greyish red capsule cap and ” 687” on the orange capsule body, containing white powder.
Danish: Gelatinekapsler, indeholdende hvidt pulver, præget med ”5 mg” i rødt på den grå-røde kapseltop og med ” 687” på den orange kapselbund.
English: Advagraf 1 mg prolonged-release hard capsules EU/1/07/387/003
Danish: Advagraf 1 mg depotkapsler, hårde EU/1/07/387/003
English: Each capsule contains 5 mg tacrolimus (as monohydrate).
Danish: Hver kapsel indeholder 5 mg tacrolimus (som monohydrat).
English: Each capsule contains 1 mg tacrolimus (as monohydrate).
Danish: Hver kapsel indeholder 1 mg tacrolimus (som monohydrat).
English: Tel: +421 2 4444 2157
Danish: Astellas Pharma s.r.o., Tel: +421 2 4444 2157
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER Advagraf 3 mg prolonged-release hard capsules
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER Advagraf 3 mg depotkapsler, hårde
English: What Advagraf looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Advagraf 0.5 mg prolonged-release hard capsules EU/1/07/387/001
Danish: Advagraf 0,5mg depotkapsler, hårde EU/1/07/387/001
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON Advagraf 5 mg prolonged-release hard capsules
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON Advagraf 5 mg depotkapsler, hårde
English: Advagraf 0.5 mg is supplied in blisters or perforated unit-dose blisters containing 10 capsules within a protective foil wrapper, including a desiccant.
Danish: Advagraf 0,5 mg findes som blisterkort eller perforeret enkeltdosisblister med 10 kapsler i en beskyttende foliepose med et tørremiddel.
English: EU/1/07/387/011 30 capsules EU/1/07/387/012 50 capsules EU/1/07/387/013 100 capsules EU/1/07/387/021 30×1 capsules EU/1/07/387/022 50×1 capsules EU/1/07/387/023 100×1 capsules
Danish: EU/1/07/387/011 30 kapsler EU/1/07/387/012 50 kapsler EU/1/07/387/013 100 kapsler EU/1/07/387/021 30×1 kapsler EU/1/07/387/022 50×1 kapsler EU/1/07/387/023 100×1 kapsler
English: • Periodic Safety Update Reports
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGS-TILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: EU/1/07/387/003 30 capsules EU/1/07/387/004 50 capsules EU/1/07/387/005 60 capsules EU/1/07/387/006 100 capsules EU/1/07/387/017 30×1 capsules EU/1/07/387/018 50×1 capsules EU/1/07/387/019 60×1 capsules EU/1/07/387/020 100×1 capsules
Danish: EU/1/07/387/003 30 kapsler EU/1/07/387/004 50 kapsler EU/1/07/387/005 60 kapsler EU/1/07/387/006 100 kapsler EU/1/07/387/017 30×1 kapsler EU/1/07/387/018 50×1 kapsler EU/1/07/387/019 60×1 kapsler EU/1/07/387/020 100×1 kapsler
English: Liver failure
Danish: Nedsat nyrefunktion
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER Advagraf 5 mg prolonged-release hard capsules
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER Advagraf 5 mg depotkapsler, hårde
English: What Advagraf is and what it is used for What you need to know before you take Advagraf How to take Advagraf
Danish: Det skal De vide, før De begynder at tage Advagraf Sådan skal De tage Advagraf Bivirkninger
English: If signs of toxicity such as severe adverse reactions are noted (see section 4.8), the dose of Advagraf may need to be reduced.
Danish: Ved tegn på toksicitet såsom alvorlige hændelser (se pkt.
English: EU/1/07/387/007 30 capsules EU/1/07/387/008 50 capsules EU/1/07/387/010 100 capsules EU/1/07/387/024 30×1 capsules EU/1/07/387/025 50×1 capsules EU/1/07/387/026 100×1 capsules
Danish: EU/1/07/387/007 30 kapsler EU/1/07/387/008 50 kapsler EU/1/07/387/010 100 kapsler EU/1/07/387/024 30×1 kapsler EU/1/07/387/025 50×1 kapsler EU/1/07/387/026 100×1 kapsler
English: Advagraf 1 mg is supplied in blisters or perforated unit-dose blisters containing 10 capsules within a protective foil wrapper, including a desiccant.
Danish: Advagraf 1 mg findes som blisterkort eller perforeret enkeltdosisblister med 10 kapsler i en beskyttende foliepose med et tørremiddel.
English: EU/1/07/387/001 30 capsules EU/1/07/387/002 50 capsules EU/1/07/387/009 100 capsules EU/1/07/387/014 30×1 capsules EU/1/07/387/015 50×1 capsules EU/1/07/387/016 100×1 capsules
Danish: EU/1/07/387/001 30 kapsler EU/1/07/387/002 50 kapsler EU/1/07/387/009 100 kapsler EU/1/07/387/014 30×1 kapsler EU/1/07/387/015 50×1 kapsler EU/1/07/387/016 100×1 kapsler
English: Advagraf 5 mg is supplied in blisters or perforated unit-dose blisters containing 10 capsules within a protective foil wrapper, including a desiccant.
Danish: Advagraf 5 mg findes som blisterkort eller perforeret enkeltdosisblister med 10 kapsler i en beskyttende foliepose med et tørremiddel.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER WRAPPERS ALUMINIUM WRAPPER Advagraf 0.5 mg prolonged-release hard capsules (30, 50, 100 Aluminium Wrapper)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ALUMINIUMPOSER Advagraf 0,5 mg depotkapsler, hårde (30, 50, 100 ALUMINIUMPOSER)
English: venoocclusive liver disease, hepatitic artery thrombosis very rare:
Danish: veneokklusiv leversygdom, trombose i leverarterie
English: Advagraf 3 mg is supplied in blisters or perforated unit-dose blisters containing 10 capsules within a protective foil wrapper, including a desiccant.
Danish: Advagraf 3 mg findes som blisterkort eller perforeret enkeltdosisblister med 10 kapsler i en beskyttende foliepose med et tørremiddel.
English: Advagraf 0.5 mg prolonged-release hard capsules
Danish: Advagraf 0,5 mg depotkapsler, hårde
English: Advagraf 1 mg prolonged-release hard capsules
Danish: Advagraf 1 mg depotkapsler, hårde
English: blood alkaline phosphatase increased, weight increased uncommon:
Danish: stigning i basisk fosfatase, vægtøgning
English: Packs of 30, 50, 60 and 100 prolonged-release capsules are available in blisters and packs of 30×1, 50×1, 60×1 and 100×1 prolonged-release capsules are available in perforated unit-dose blisters.
Danish: De findes i pakker med 30, 50, 60 og 100 depotkapsler, hårde, i blister og i pakker med 30×1, 50×1, 60×1 og 100×1 depotkapsler, hårde, i perforeret enkeltdosisblister.
English: Packs of 30, 50 and 100 prolonged-release hard capsules are available in blisters and packs of 30×1, 50×1 and 100×1 prolonged-release capsules are available in perforated unit-dose blisters.
Danish: De findes i pakker med 30, 50 og 100 depotkapsler, hårde, i blister og i pakker med 30×1, 50×1 og 100×1 depotkapsler, hårde, i perforeret enkeltdosisblister.
English: myasthenia
Danish: myasteni
English: Prolonged-release hard capsule.
Danish: Depotkapsel, hård
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER WRAPPERS ALUMINIUM WRAPPER Advagraf 5 mg prolonged-release hard capsules (30, 50, 100 Aluminium Wrapper)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ALUMINIUMPOSER Advagraf 5 mg depotkapsler, hårde (30, 50, 100 ALUMINIUMPOSER)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER WRAPPERS ALUMINIUM WRAPPER Advagraf 3 mg prolonged-release hard capsules (30, 50, 100 Aluminium Wrapper)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ALUMINIUMPOSER Advagraf 3 mg depotkapsler, hårde (30, 50, 100 ALUMINIUMPOSER)
English: Advagraf 3 mg prolonged-release hard capsules
Danish: Advagraf 3 mg depotkapsler, hårde
English: Advagraf 5 mg prolonged-release hard capsules
Danish: Advagraf 5 mg depotkapsler, hårde
English: Changes in blood clotting, reduction in the number of all types of blood cells (seen in blood tests) Dehydration, inability to urinate - Abnormal blood test results: reduced protein or sugar, increased phosphate, increase of the enzyme lactate dehydrogenase - Coma, bleeding in the brain, stroke, paralysis, brain disorder, speech and language abnormalities, memory problems
Danish: stigning af urinsyre eller fedt i blodet, nedsat appetit, øget surhed af blodet, andre ændringer i blodets salte (ses i blodprøver) - Ængstelse, forvirring og desorientering, depression, humørsvingninger, mareridt,
English: Tell your doctor if any of the following apply to you: - if you are taking any medicines mentioned below under ‘Other medicines and Advagraf'.
Danish: Fortæl Deres læge, hvis et eller flere af følgende punkter gælder for Dem: - hvis De tager noget af den medicin, som er nævnt under ”Brug af anden medicin sammen med Advagraf” - hvis De har eller har haft leverproblemer - hvis De har diarré i mere end én dag - hvis De får stærke mavesmerter med eller uden andre symptomer, som kulderystelser, feber, kvalme eller opkastning - hvis De har en ændring i hjerterytmen, som kaldes ”QT-forlængelse”.
English: Stevens Johnson syndrome Musculoskeletal and connective tissue disorders common:
Danish: Knogler, led, muskler og bindevæv Almindelig:
English: Advagraf 0.5 mg prolonged-release hard capsules Pack sizes: 30, 50 and 100 prolonged-release hard capsules in blisters or 30×1, 50×1 and 100×1 prolonged-release hard capsule in unit-dose perforated blisters.
Danish: Pakningsstørrelser: 30, 50 og 100 depotkapsler, hårde, i blister eller 30×1, 50×1 og 100×1 depotkapsler, hårde, i perforeret enkeltdosisblister.
English: EMA/300585/2012 EMEA/H/C/002622
Danish: EMA/CHMP/158913/2012 EMEA/H/C/002622
English: This medicine is the same as Rilutek, which is already authorised in the European Union (EU).
Danish: Lægemidlet er identisk med Rilutek, som allerede er godkendt i Den Europæiske Union (EU).
English: The full EPAR for Riluzole Zentiva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Riluzole Zentiva findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Riluzole Zentiva on 7 May 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Riluzole Zentiva den 7. maj 2012.
English: This is a summary of the European public assessment report (EPAR) for Riluzole Zentiva.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Riluzole Zentiva.
English: Riluzole stops the release of glutamate and this may help in preventing the nerve cells being damaged.
Danish: Riluzol standser frigivelsen af glutamat, og dette kan medvirke til at forebygge skade på nervecellerne.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Riluzole Zentiva.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Riluzole Zentiva.
English: For more information about treatment with Riluzole Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Riluzole Zentiva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The effectiveness of Riluzole Zentiva has been compared with that of placebo (a dummy treatment) in three studies involving a total of 1,282 patients.
Danish: Virkningen af Riluzole Zentiva blev sammenlignet med placebo (virkningsløs behandling) i tre undersøgelser med tilsammen 1 282 patienter.
English: The company that makes Rilutek has agreed that its scientific data can be used for Riluzole Zentiva (‘informed consent').
Danish: Virksomheden, som fremstiller Rilutek, har indvilget i, at dens videnskabelige oplysninger må anvendes for Riluzole Zentiva (‘informeret samtykke').
English: In adult and elderly patients, it is given as 100 mg a day (50 mg every 12 hours).
Danish: Til voksne og ældre patienter gives lægemidlet i en dosis på 100 mg dagligt (50 mg hver 12. time).
English: Riluzole Zentiva 50 mg/day was no more effective than placebo and 200 mg/day was no more effective than 100 mg/day.
Danish: Riluzole Zentiva, 50 mg dagligt, var ikke mere effektivt end placebo, og 200 mg dagligt var ikke mere effektivt end 100 mg dagligt.
English: It is thought that the destruction of nerve cells in motor neurone disease may be caused by too much glutamate, a neurotransmitter (chemical messenger).
Danish: Det menes, at ødelæggelsen af nervecellerne ved sygdommen kan skyldes for meget glutamat, der er en neurotransmitter (et kemisk signalstof).
English: Other information about Riluzole Zentiva
Danish: Andre oplysninger om Riluzole Zentiva
English: Treatment with Riluzole Zentiva should only be started by a specialist doctor with experience in the management of motor neurone diseases.
Danish: Behandling med Riluzole Zentiva bør kun iværksættes af en speciallæge med erfaring i behandling af sygdomme i motorneuronerne.
English: Riluzole Zentiva is a medicine containing the active substance riluzole.
Danish: Riluzole Zentiva er et lægemiddel, der indeholder det aktive stof riluzol.
English: Across the studies, Riluzole Zentiva was given as 50, 100 or 200 mg per day, and for up to 18 months.
Danish: I undersøgelserne blev Riluzole Zentiva givet i en dosering på 50, 100 eller 200 mg dagligt i op til 18 måneder.
English: The Committee recommended that Riluzole Zentiva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Riluzole Zentiva.
English: EPAR summary for the public riluzole
Danish: EPAR sammendrag for offentligheden riluzol
English: They noted that there is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms, and that it has not been shown to be effective in the late stages of ALS.
Danish: Udvalget konstaterede også, at det ikke er påvist, at Riluzole Zentiva virker på den motoriske (bevægelsesmæssige) funktion, lungefunktionen, fascikulationer (muskeltrækninger), muskelstyrke eller motoriske symptomer, og at der ikke er påvist virkning i de sene stadier af ALS.
English: The active substance in Riluzole Zentiva, riluzole, acts on the nervous system.
Danish: Det aktive stof i Riluzole Zentiva, riluzol, virker på nervesystemet.
English: For the full list of all side effects reported with Riluzole Zentiva, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Riluzole Zentiva fremgår af indlægssedlen.
English: Riluzole Zentiva is used in patients with amyotrophic lateral sclerosis (ALS).
Danish: Riluzole Zentiva anvendes til behandling af amyotrofisk lateral sklerose (ALS).
English: The most common side effects seen with Riluzole Zentiva (in more than 1 patient in 10) are nausea (feeling sick), asthenia (weakness) and abnormal liver tests (increased in liver enzymes levels).
Danish: De hyppigste bivirkninger ved Riluzole Zentiva (som optræder hos flere end 1 ud af 10 patienter) er kvalme, kraftesløshed og abnorme leverprøver (forhøjede leverenzymer i blodet).
English: Riluzole Zentiva must not be used in people who are hypersensitive (allergic) to riluzole or any of the other ingredients.
Danish: Riluzole Zentiva må ikke anvendes hos personer, der er overfølsomme (allergiske) over for riluzol eller andre af indholdsstofferne.
English: Looking at the results of the three studies together, over 18 months, patients who received Riluzole Zentiva 100 mg/day had an average survival time that was about two months longer than the survival time for patients who received placebo.
Danish: Hvis man ser på resultaterne af alle tre undersøgelser under ét, overlevede de patienter, der fik Riluzole Zentiva, 100 mg dagligt, i gennemsnit ca. 2 måneder længere end de patienter, der fik placebo.
English: The average survival time was significantly longer for patients who received Riluzole Zentiva compared with patients who received placebo.
Danish: Den gennemsnitlige overlevelsestid for de patienter, der fik Riluzole Zentiva, var signifikant længere end for dem, der fik placebo.
English: Riluzole Zentiva must also not be given to women who are pregnant or breast-feeding.
Danish: Riluzole Zentiva må heller ikke anvendes til patienter, der er gravide eller ammer.
English: Riluzole Zentiva is used to extend the patient's life, or the time before they need to use mechanical ventilation.
Danish: Riluzole Zentiva anvendes til at forlænge patientens liv eller den tid, der går, til patienten skal have mekanisk ventilation (respirator).
English: The CHMP decided that Riluzole Zentiva's benefits are greater than its risks to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Riluzole Zentiva opvejer risiciene vil forlængelse af overlevelsestiden eller tiden til mekanisk ventilation er nødvendig for patienter med amyotrofisk lateral sklerose.
English: Riluzole Zentiva should not be used in patients with any other form of motor neurone disease.
Danish: Riluzole Zentiva bør ikke anvendes hos patienter med andre sygdomme i motorneuronerne.
English: What is the risk associated with Riluzole Zentiva?
Danish: Hvilken risiko er der forbundet med Riluzole Zentiva?
English: Riluzole Zentiva must not be used in patients who have liver disease or who have abnormally high levels of liver enzymes.
Danish: Riluzole Zentiva bør ikke anvendes til patienter med leversygdom eller unormalt højt indhold af leverenzymer i blodet.
English: Why has Riluzole Zentiva been approved?
Danish: Hvorfor blev Riluzole Zentiva godkendt?
English: ALS is a form of motor neurone disease where attacks of the nerve cells responsible for sending instructions to the muscles lead to weakness, muscle waste and paralysis.
Danish: ALS er en sygdom i motorneuronerne, dvs. de nerveceller, der sender instruktioner til musklerne.
English: How has Riluzole Zentiva been studied?
Danish: Hvordan blev Riluzole Zentiva undersøgt?
English: What benefit has Riluzole Zentiva shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Riluzole Zentiva?
English: For more information please see the package leaflet.
Danish: De yderligere oplysninger fremgår af indlægssedlen.
English: What is Riluzole Zentiva?
Danish: Hvad er Riluzole Zentiva?
English: What is Riluzole Zentiva used for?
Danish: Hvad anvendes Riluzole Zentiva til?
English: How is Riluzole Zentiva used?
Danish: Hvordan anvendes Riluzole Zentiva?
English: 19 May 2011
Danish: 19. maj 2011
English: The European Commission issued a decision on 19 May 2011.
Danish: Europa-Kommissionen traf en afgørelse den 19. maj 2011.
English: The medicine is available in all Member States of the European Union as well as Iceland and Norway.
Danish: Lægemidlet fås i alle EU's medlemsstater samt i Island og Norge.
English: The recommended dose for adults, including elderly patients, is one 1 mg tablet once a day.
Danish: Den anbefalede dosis til voksne, herunder ældre patienter, er én 1 mg tablet en gang dagligt.
English: Arimidex is authorised in the EU via mutual recognition and national procedures.
Danish: Arimidex er godkendt i EU via den gensidige anerkendelsesprocedure og nationale procedurer.
English: What is Arimidex?
Danish: Hvad er Arimidex?
English: The same dose is recommended in patients with mild liver problems or with mild to moderate kidney problems.
Danish: Samme dosis anbefales til patienter med milde leverproblemer eller med milde til moderate nyreproblemer.
English: On 22 July 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Arimidex in the EU.
Danish: Den 22. juli 2010 henviste Europa-Kommissionen sagen til CHMP med henblik på harmonisering af markedsføringstilladelserne for Arimidex i EU.
English: Arimidex must not be used in:
Danish: Arimidex må ikke anvendes til:
English: ‘Hormone receptor-positive' means that the cancer depends on the presence of oestrogen in order to grow.
Danish: "Hormonreceptorpositiv" betyder, at kræften er afhængig af tilstedeværelsen af østrogen for at kunne vokse.
English: Why was Arimidex reviewed?
Danish: Hvorfor blev Arimidex vurderet igen?
English: • Patients known to be hypersensitive (allergic) to the active substance anastrozole, or to any of the other ingredients.
Danish: • patienter med kendt allergi (overfølsomhed) over for det aktive stof anastrozol eller et af de øvrige indholdsstoffer.
English: Arimidex belongs to a group of medicines called ‘aromatase inhibitors' which reduce the amount of the hormone oestrogen made in the body by blocking the action of an enzyme in the body called ‘aromatase'.
Danish: Arimidex tilhører en gruppe lægemidler, der kaldes "aromatasehæmmere", som reducerer mængden af hormonet østrogen i kroppen ved at blokere virkningen af et enzym i kroppen, der kaldes "aromatase".
English: The Committee also harmonised other sections of the SmPC, including the Special Warnings, which state that tamoxifen and oestrogen-containing therapies should not be given with Arimidex and that Arimidex should be used with caution in patients with severe kidney problems or moderate to severe liver problems.
Danish: Udvalget harmoniserede ligeledes andre punkter i produktresuméet, herunder de særlige advarsler, hvor der står, at tamoxifen og østrogenholdige behandlinger ikke må gives sammen med Arimidex, og at Arimidex skal anvendes med forsigtighed hos patienter med svære nyreproblemer eller moderate til svære leverproblemer.
English: The CHMP agreed that Arimidex should be used for:
Danish: CHMP vedtog, at Arimidex skal anvendes til:
English: The company that markets Arimidex is AstraZeneca.
Danish: Den virksomhed, der markedsfører Arimidex, er AstraZeneca.
English: Questions and answers on Arimidex (anastrozole, 1 mg tablets)
Danish: Spørgsmål og svar vedrørende Arimidex (anastrozol, 1 mg tabletter)
English: Arimidex is a medicine that contains the active substance anastrozole.
Danish: Arimidex er et lægemiddel, der indeholder det aktive stof anastrozol.