FrancophonIA/ELRC3.0 huggingface dataset:
English: Dr Calvo-Rojas (Spain)
Danish: Dr. Calvo-Rojas (Spanien)
English: 1 Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Danish: 1 Artikel 30 i direktiv 2001/83/EF, med senere ændringer, indbringelse på grund af indbyrdes afvigende afgørelser vedtaget af medlemsstaterne
English: Why was Protium reviewed?
Danish: Hvorfor blev Protium vurderet igen?
English: 6 April 2009, 24 August 2009 and 19 October
Danish: 6. april 2009, 24. august 2009 og 19. oktober
English: The dose of the tablets may be doubled in cases where there has been no response to treatment.
Danish: Tabletternes dosis kan fordobles, såfremt der ikke har været nogen respons på behandlingen.
English: By blocking the pumps, pantoprazole reduces acid production.
Danish: Ved at blokere for pumperne reducerer pantoprazol syreproduktionen.
English: The active substance in Protium, pantoprazole, is a proton pump inhibitor (PPI).
Danish: Det aktive stof i Protium, pantoprazol, er en protonpumpehæmmer (PPI).
English: The Committee was of the opinion that the concomitant use of atazanavir and other anti-HIV medicines should not be contraindicated, but that a warning should be added in section 4.4.
Danish: Udvalget var af den opfattelse, at samtidig brug af atazanavir og andre hivlægemidler ikke bør være kontraindiceret, men at der bør medtages en advarsel i punkt 4.4.
English: On 3 September 2008, the European Commission referred the matter to the Committee for Medicinal Products for Human Use (CHMP) in order to harmonise the marketing authorisations for Protium and associated names in the EU and the EEA.
Danish: Den 3. september 2008 henviste Europa-Kommissionen sagen til Udvalget for Lægemidler til Mennesker (CHMP) med henblik på harmonisering af markedsføringstilladelserne for Protium og relaterede navne i EU og EØS.
English: The CHMP agreed on a harmonised indication (the disease for which the medicine may be used).
Danish: CHMP godkendte en harmoniseret indikation (den sygdom, som lægemidlet kan anvendes til).
English: Protium is used to treat diseases where the stomach produces too much acid.
Danish: Protium anvendes til at behandle sygdomme, hvor der produceres for meget mavesyre.
English: The European Medicines Agency has completed a review of Protium and associated names.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en revurdering af Protium og relaterede navne.
English: The company that markets these medicines is Nycomed.
Danish: Disse lægemidler markedsføres af virksomheden Nycomed.
English: The CHMP harmonised the SPC sections on pregnancy and lactation, the ability to drive and use machines, undesirable effects and overdose.
Danish: CHMP harmoniserede produktresuméets punkter om graviditet og amning, virkning på evnen til at føre motorkøretøj eller betjene maskiner, bivirkninger og overdosering.
English: The CHMP also included a warning that treatment with Protium and other PPIs may lead to an increase in infections of the gut.
Danish: CHMP medtog ligeledes en advarsel om, at behandling med Protium og andre protonpumpehæmmere kan medføre en stigning i antallet af infektioner i tarmene.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Protium and associated names in the European Union (EU) and the European Economic Area (EEA).
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for at harmonisere ordineringsoplysningerne for Protium og relaterede navne i Den Europæiske Union (EU) og Det Europæiske Økonomiske Samarbejdsområde (EØS).
English: Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions are treated with a daily dose of 80 mg of pantoprazole, either as two 40 mg tablets or an injection.
Danish: Zollinger-Ellisons syndrom og andre patologiske hypersekretionstilstande behandles med en daglig dosis på 80 mg pantoprazol, enten som to 40 mg tabletter eller som injektion.
English: • stomach or duodenal ulcer,
Danish: • mavesår eller duodenal ulcus (sår på tolvfingertarmen),
English: The 40 mg gastroresistant tablets can also be used to eradicate Helicobacter pylori (H. pylori) in combination with appropriate antibiotic therapy in patients with H. pylori associated ulcers.
Danish: 40 mg enterotabletter kan ligeledes anvendes til at fjerne Helicobacter pylori (H. pylori) i kombination med passende antibiotikabehandling hos patienter med H. pylori-associeret ulcus.
English: This can be increased to 40 mg a day in cases where symptoms of reflux oesophagitis relapse.
Danish: Dosis kan øges til 40 mg om dagen, såfremt der optræder tilbagefald af symptomer på refluksøsofagitis.
English: Protium is also available in the EU and EEA under other trade names: Anagastra, Apton, Controloc, Eupantol, Inipomp, Pantec, Pantecta, Pantipp, Panto-Byk-20, Panto-Byk-40, Panto-Byk-IV, Pantoc,
Danish: Protium markedsføres ligeledes i EU og EØS under andre særnavne: Anagastra, Apton, Controloc, Eupantol, Inipomp, Pantec, Pantecta, Pantipp, Panto-Byk-20, Panto-Byk-40, Panto-Byk-IV, Pantoc, Pantoloc, PantoLomberg, Pantopan, Pantoprazol 20 mg Byk, Pantoprazol NYC, Pantoprazol Nycomed, Pantoprazol-Byk, Pantoprazole ALTANA, Pantoprazole Lomberg, Pantorc, Pantozol, Peptazol, Rifun, Somac, Ulcotenal, Zurcal, Zurcale og Zurcazol.
English: Protium can also be used for the prevention of the stomach ulcers that can be caused by some medicines used to treat pain and inflammations called non-selective non-steroidal anti-inflammatory drugs (NSAIDs), when the patient needs continuous NSAID treatment, and to help rid the stomach of a bacterium called Helicobacter pylori, which is known to cause stomach ulcers.
Danish: Protium kan ligeledes anvendes til forebyggelse af mavesår, der skyldes visse lægemidler, som anvendes til behandling af smerter og betændelse, kaldet non-selektive, non-steroide antiinflammatoriske lægemidler (NSAID'er), når patienten har brug for fortsat NSAID-behandling, og for at hjælpe med at fjerne en bakterie i maven, der kaldes Helicobacter pylori, og som er kendt for at forårsage mavesår.
English: The dose can be adjusted depending on the amount of acid being secreted in the stomach.
Danish: Dosis kan justeres ud fra den mængde mavesyre, der produceres.
English: The Committee recommended that the 40 mg gastro-resistant tablets and the 40 mg powder for solution for injection should be used to treat reflux oesophagitis, gastric and duodenal ulcer, and Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions.
Danish: Udvalget anbefalede, at 40 mg enterotabletter og 40 mg pulver til injektionsvæske, opløsning, anvendes til behandling af refluksøsofagitis, gastroduodenal ulcus og Zollinger-Ellisons syndrom samt andre patologiske hypersekretionstilstande.
English: The recommended dose for reflux oesophagitis and gastric or duodenal ulcers is one 40 mg tablet or one 40 mg injection daily.
Danish: Den anbefalede dosis ved refluksøsofagitis og gastrisk eller duodenal ulcus er én 40 mg tablet eller én 40 mg injektion dagligt.
English: • reflux disease to treat symptoms such as heartburn and acid regurgitation (acid flowing up in the mouth),
Danish: • reflukssygdom, hvor det behandler symptomer såsom halsbrand og sure opstød,
English: The Committee recommended that the 20 mg gastro-resistant tablets should be used for the treatment of symptomatic gastro-oesophageal reflux disease, the long-term management and prevention of relapse in reflux oesophagitis and the prevention of gastroduodenal ulcers induced by non-selective nonsteroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment.
Danish: Udvalget anbefalede, at 20 mg enterotabletter anvendes til behandling af symptomatisk gastroøsofageal reflukssygdom, langvarig behandling og forebyggelse af tilbagefald ved refluksøsofagitis samt forebyggelse af gastroduodenal ulcus forårsaget af non-selektive, non-steroide antiinflammatoriske lægemidler (NSAID'er) hos patienter i risikogruppen med behov for fortsat NSAIDbehandling.
English: The recommended dosage for the treatment of symptomatic gastro-oesophageal reflux disease, the long-term management of reflux oesophagitis and the prevention of gastroduodenal ulcers in patients taking NSAIDs, the recommended dose is one 20 mg tablet once daily.
Danish: Den anbefalede dosering til behandling af symptomatisk gastroøsofageal reflukssygdom, langvarig behandling af refluksøsofagitis og forebyggelse af gastroduodenal ulcus hos patienter, der tager NSAID'er, er én 20 mg tablet én gang dagligt.
English: To eradicate H. pylori in the stomach, the recommended dose is one 40 mg gastro-resistant tablet taken twice a day in combination with appropriate antibiotic treatment.
Danish: pylori i maven er en 40 mg enterotablet to gange dagligt i kombination med en passende antibiotikabehandling.
English: Protium has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Danish: Koordinationsgruppen for gensidig anerkendelse og decentrale procedurer - lægemidler til mennesker (CMD(h)) har bestemt, at Protium bør harmoniseres.
English: Questions and answers on the referral for Protium and associated names pantoprazole, 20 or 40 mg gastro-resistant tablets and 40 mg powder for solution for injection
Danish: Pantoprazol, 20 eller 40 mg enterotabletter og 40 mg pulver til injektionsvæske, opløsning
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Samtidig indgivelse af atazanavir og protonpumpehæmmere anbefales ikke.
English: Unopened vial 12 months.
Danish: Uåbnet hætteglas 12 måneder.
English: Other appropriate symptomatic measures should be taken, as needed.
Danish: Andre relevante symptomatiske tiltag bør iværksættes efter behov.
English: Results on these end-points were supportive of the primary end-points results.
Danish: Resultaterne for disse endepunkter understøttede de primære endepunktsresultater.
English: • hair loss (in most cases normal hair growth should return)
Danish: • hårtab (i de fleste tilfælde vil normal hårvækst vende tilbage)
English: The use of gloves is recommended.
Danish: Brug af handsker anbefales.
English: TTP = time to progression; “ne” indicates that it could not be estimated or it was not yet reached.
Danish: TTP = tid til progression; “ne” indikerer at den ikke kunne estimeres eller endnu ikke var nået.
English: 73% of the cutaneous reactions were reversible within 21 days.
Danish: 73% af de kutane reaktioner var reversible inden for 21 dage.
English: - if you have a severe liver disease.
Danish: - hvis du har en alvorlig leversygdom.
English: Median time to progression (weeks):
Danish: Median tid til progression (uger):
English: In some cases concomitant factors may have contributed to the development of these effects.
Danish: I nogle tilfælde kan samtidigt tilstedeværende faktorer have bidraget til udviklingen af disse bivirkninger.
English: If crystals appear, the solution must no longer be used and shall be discarded.
Danish: Hvis der forekommer krystaller, må opløsningen ikke længere anvendes og skal kasseres.
English: • change or absence of menstrual period
Danish: • ændring eller udeblivelse af menstruationer
English: • fever: if this happens you must tell your doctor immediately
Danish: • feber: hvis dette forekommer, skal du straks fortælle det til din læge
English: A total of 70 Gy was recommended for accelerated regimens and 74 Gy for hyperfractionated schemes.
Danish: I alt 70 Gy anbefales ved accelererede regimer og 74 Gy for hyperfraktionerede systemer.
English: Overall survival (Primary end-point):
Danish: Total overlevelse (Primært endepunkt):
English: In both arms, quality of life measured by the EORTC questionnaire was comparable and stable during treatment and follow-up.
Danish: I begge arme blev livskvaliteten målt ved hjælp af EORTC-spørgeskemaet og var sammenlignelig og stabil under behandling og opfølgning.
English: A final analysis was performed with an actual median follow up of 96 months.
Danish: Der blev udført en endelig analyse med en aktuel median followup på 96 måneder.
English: • raised liver enzymes (hence the need for regular blood tests).
Danish: • forhøjede leverenzymer (derfor behovet for regelmæssige blodprøver)
English: The efficacy and safety evaluation solely addressed survival endpoints and the success of organ preservation was not formally addressed.
Danish: Evalueringen af effekten og sikkerheden fokuserede udelukkende på overlevelsesendepunkter, mens succesrig organbevarelse ikke blev undersøgt formelt.
English: The overall response rate was 6.8% in the evaluable patients, and the median duration of response was 26.1 weeks.
Danish: Den totale responsrate var 6,8% hos de evaluerbare patienter, og den mediane responsvarighed var 26,1 uge.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31 January 2012
Danish: Dato for første tilladelse: 31. januar 2012
English: Recommendations for the safe handling:
Danish: Instruktioner vedrørende sikker håndtering:
English: If the patient continues to experience these reactions at 60 mg/m², the treatment should be discontinued.
Danish: Hvis patienten fortsætter med at få disse reaktioner ved 60 mg/m² bør behandlingen stoppes.
English: No statistical differences were observed between treatment groups for Global Quality of Life.
Danish: Der blev ikke observeret statistiske forskelle i forhold til global livskvalitet grupperne imellem.
English: A total of 1006 patients with KPS ≥ 60 were randomized to the following treatment groups:
Danish: I alt 1.006 patienter med KPS ≥ 60 blev randomiseret til følgende behandlingsgrupper:
English: In case of overdose, the patient should be kept in a specialised unit and vital functions closely monitored.
Danish: I tilfælde af overdosering skal patienten indlægges på et specialafsnit og de vitale funktioner monitoreres nøje.
English: Mylan - if the number of white blood cells is too low.
Danish: - hvis antallet af hvide blodlegemer er for lavt.
English: Surgery on the primary site of disease and/or neck could be considered at anytime following completion of CRT.
Danish: Operation på det primære sygdomssted og/eller hals kunne overvejes på et hvilket som helst tidspunkt efter endt CRT.
English: The binding of docetaxel to microtubules does not alter the number of protofilaments.
Danish: Docetaxels binding til mikrotubuli ændrer ikke antallet af protofilamenter.
English: The length of a treatment cycle was 3 weeks for the TCF arm and 4 weeks for the CF arm.
Danish: Længden af en behandlingscyklus var 3 uger for TCF-armen og 4 uger for CF-armen.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Danish: Hyppigheder defineres som: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000); frekvens ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Survival data, median time to progression and response rates for two arms of the study are illustrated in the following table:
Danish: Overlevelsesdata, mediantid til progression og responsrater for to af studiearmene er illustreret i nedenstående tabel:
English: ER/PR-negative or Grade 3 or tumor size >5 cm
Danish: ER/PR-negativ eller grad 3 eller tumorstørrelse >5 cm
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende PSUR'es for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: This is because Docetaxel Mylan or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Danish: Dette er fordi Docetaxel Mylan eller den anden medicin måske ikke virker så godt som forventet, og du måske nemmere får bivirkninger.
English: EXP: Read the leaflet for the shelf life of the diluted medicine.
Danish: EXP: Læs indlægssedlen for holdbarhed af den fortyndede medicin.
English: A minority of patients were tested using fluorescence in-situ hybridization (FISH).
Danish: Et mindretal af patienter blev testet ved hjælp af fluorescens in situ hybridisering (FISH).
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler med undtagelse af dem, der nævnes i pkt.
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 25°C.
English: Fluid retention has not been accompanied by acute episodes of oliguria or hypotension.
Danish: Væskeretention har ikke været forbundet med akutte episoder af oliguri eller hypotension.
English: • change in the colour of your nails, which may detach
Danish: • ændring af farven på fingerneglene, som kan løsne sig
English: The late phase is due, in part, to a relatively slow efflux of docetaxel from the peripheral compartment.
Danish: Den sene fase skyldes til dels den relativt langsomme efflux af docetaxel fra perifere compartments.
English: Preparation of the intravenous administration:
Danish: Tilberedning af den intravenøse administration:
English: Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Docetaxel Mylan.
Danish: Din læge kan ændre dosis og dosisfrekvensen afhængig af dine blodprøver, din almene helbredstilstand og din reaktion på Docetaxel Mylan.
English: For docetaxel/carboplatin combination, neither equivalent nor non-inferior efficacy could be proven compared to the reference treatment combination VCis.
Danish: Ved kombinationen docetaxel/carboplatin kunne der hverken påvises ækvivalent eller non-inferiør effekt sammenlignet med referencebehandlingen kombination VCis.
English: For combination with trastuzumab, adverse events (all grades) reported in ≥ 10% are displayed.
Danish: I kombination med trastuzumab, vises de bivirkninger (alle grader), som er rapporteret hos ≥ 10%.
English: • loss of appetite (anorexia)
Danish: • mistet appetit (anoreksi)
English: Docetaxel is more than 95% bound to plasma proteins.
Danish: Docetaxel binder mere end 95% til plasmaproteiner.
English: Given the fact that docetaxel every week presented a slightly better safety profile than docetaxel every 3 weeks, it is possible that certain patients may benefit from docetaxel every week.
Danish: Eftersom docetaxel indgivet hver uge udviste en lidt bedre sikkerhedsprofil end docetaxel indgivet hver 3. uge, er det muligt, at nogle patienter kan have fordel af at få docetaxel hver uge.
English: Primary prophylactic G-CSF was made mandatory in TAC arm after 230 patients were randomized.
Danish: Primær G¬CSF-profylakse blev gjort obligatorisk i TAC-armen, efter 230 patienter var blevet randomiseret.
English: As a result, caution should be exercised when treating patients with these medicinal products as concomitant therapy since there is a potential for a significant interaction.
Danish: Man bør derfor udvise forsigtighed ved samtidig medicinering med disse lægemidler på grund af risikoen for signifikant interaktion.
English: 1Full analysis set (intent-to-treat)
Danish: 1Fuldt analysesæt (intent-to-treat)
English: • infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets
Danish: • infektioner, fald i antallet af røde blodlegemer (anæmi) eller hvide blodlegemer (som er vigtige for at bekæmpe infektioner) og blodplader
English: 117 allée des parcs 69800 Saint Priest France
Danish: 117 allée des parcs 69800 Saint Priest Frankrig
English: 117 allée des Parcs F-69 800 Saint Priest France
Danish: 117 allée des Parcs F-69 800 Saint Priest Frankrig
English: About 80% of the radioactivity recovered in faeces is excreted during the first 48 hours as one major inactive metabolite and 3 minor inactive metabolites and very low amounts of unchanged medicinal product.
Danish: Ca. 80% af radioaktiviteten i fæces udskilles i løbet af de første 48 timer i form af en primær inaktiv metabolit, 3 mindre vigtige inaktive metabolitter og meget lave koncentrationer af uomdannet lægemiddel.
English: Your doctor will calculate your body surface area in square meters (m²) and will determine the dose you should receive.
Danish: Din læge vil beregne din legemsoverflade i m² og bestemme den dosis, du skal have.
English: Patients should be monitored for symptoms of congestive heart failure during therapy and during the follow up period.
Danish: Patienter bør monitoreres for symptomer på kongestivt hjertesvigt under behandlingen og under followup-perioden.
English: G-CSF was used for secondary prophylaxis in 19.3% of patients (10.7% of the cycles).
Danish: G¬CSF blev brugt som sekundær profylakse hos 19,3% af patienterne (10,7% af cyklusserne).
English: Progressive Disease as Best Overall Response (%) *Unstratified logrank test
Danish: Progressiv sygdom som bedste totale respons (%) * Ustratificeret log-rank test
English: This was also statistically significant with an HR of 0.71; 95% CI 0.56-0.90; log-rank test p = 0.004.
Danish: Dette var også statistisk signifikant med en HR på 0,71; 95% CI 0,56-0,90; log-rank test p = 0,004.
English: Before each treatment with Docetaxel Mylan, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel Mylan.
Danish: Før hver behandling med Docetaxel Mylan, vil du få taget blodprøver for at kontrollere, om du har nok blodceller og den nødvendige leverfunktion til at kunne få Docetaxel Mylan.
English: Disease-free survival (DFS) was the primary efficacy endpoint and Overall survival (OS) was the secondary efficacy endpoint.
Danish: Sygdomsfri overlevelse (DFS) var det primære effektendepunkt, og total overlevelse (OS) var det sekundære effektendepunkt.
English: In this study, 87% of patients had disease that was IHC 3+, and 95% of patients entered had disease that was IHC 3+ and/or FISH positive.
Danish: I dette studie havde 87% af patienterne sygdom, der var IHC 3+, og 95% af de inkluderede patienter havde sygdom, der var IHC 3+ og/eller FISH-positiv.
English: Lethargy
Danish: Lethargi
English: TAC-treated patient subsets according to prospectively defined major prognostic factors were analyzed in the primary analysis (at the median follow-up time of 77 months) (see table below):
Danish: Undergrupper af TAC-behandlede patienter efter prospektivt definerede betydningsfulde prognostiske faktorer blev analyseret i den primære analyse (ved median followup-periode på 77 måneder) (se tabel nedenfor):
English: You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy, because Docetaxel Mylan may be harmful for the unborn baby.
Danish: Du må ikke blive gravid under behandling med dette lægemiddel, og du skal bruge effektiv prævention under behandlingen, fordi Docetaxel Mylan kan skade det ufødte barn.
English: In cases of overdose, exacerbation of adverse events may be expected.
Danish: Ved overdosering kan der forventes forværring af bivirkningerne.
English: The carcinogenic potential of docetaxel has not been studied.
Danish: Docetaxels karcinogene potentiale er ikke undersøgt.
English: These were reversible upon discontinuation of the infusion.
Danish: Disse bivirkninger var reversible ved afbrydelse af infusionen.
English: Docetaxel is highly protein bound (> 95%).
Danish: Docetaxel er i udstrakt grad proteinbundet (> 95%).