FrancophonIA/ELRC3.0 huggingface dataset:
English: One film-coated tablet contains 40 mg of valsartan.
Danish: En filmovertrukken tablet indeholder 40 mg valsartan.
English: In patients who weigh less than 35 kg the usual dose is 40 mg of valsartan once daily.
Danish: Til patienter, som vejer 35 kg eller mere, er den sædvanlige startdosis 80 mg valsartan en gang daglig.
English: • spinning sensation (vertigo)
Danish: • roterende/svimlende følelse (svimmelhed)
English: There is currently no experience on the safe use in patients with a creatinine clearance <10 ml/min and patients undergoing dialysis, therefore valsartan should be used with caution in these patients.
Danish: Der er på nuværende tidspunkt ingen erfaring vedrørende sikker brug til patienter med kreatininclearance <10 ml/min og til patienter i dialyse.
English: Diovan is contraindicated in patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis (see sections 4.3, 4.4 and 5.2).
Danish: Diovan er kontraindiceret hos patienter med svært nedsat leverfunktion, biliær cirrose og hos patienter med kolestase (se pkt.
English: Heart Failure
Danish: Hjertesvigt
English: One film-coated tablet contains 80 mg of valsartan.
Danish: En filmovertrukken tablet indeholder 80 mg valsartan.
English: • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: • Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: • if you are being treated after a heart attack, a combination with ACE inhibitors (a medication to treat heart attack) is not recommended.
Danish: • hvis du er i behandling efter et hjerteanfald, frarådes en kombination med ACE-hæmmere
English: • decrease of level of haemoglobin and decrease of the percentage of red blood cells in the blood
Danish: • nedsat hæmoglobintal og fald i procenten af røde blodlegemer i blodet (hvilket kan føre til anæmi i alvorlige tilfælde)
English: No dose adjustment is required for adult patients with a creatinine clearance >10 ml/min (see sections 4.4 and 5.2).
Danish: Der kræves ingen dosisjustering for voksne patienter med en kreatinin-clearance >10 ml/min (se pkt.
English: film coated tablets 40 mg
Danish: film coated tablets
English: No dose adjustment is required for paediatric patients with a creatinine clearance >30 ml/min (see sections 4.2 and 5.2).
Danish: Dosisjustering er ikke nødvendig til pædiatriske patienter med kreatininclearance >30 ml/min (se pkt.
English: In patients with mild to moderate hepatic impairment without cholestasis, Diovan should be used with caution (see sections 4.2 and 5.2).
Danish: Diovan bør anvendes med forsigtighed til patienter med let til moderat nedsat leverfunktion uden kolestase (se pkt.
English: Reductions in systolic blood pressure were comparable in patients receiving valsartan (15 mmHg) and enalapril (14 mm Hg) (non-inferiority p-value <0.0001).
Danish: De patienter, der vejede 35 kg og <80 kg, fik valsartan 160 mg eller enalapril 20 mg, og de, der vejede 80 kg, fik valsartan 320 mg eller enalapril 40 mg. Sænkningen i systolisk blodtryk var ens for patienter, som fik valsartan (15 mmHg) og enalapril (14 mmHg) (non-inferioritet p-værdi <0,0001).
English: Cardiac failure
Danish: (medicin mod hjerteanfald).
English: No dose adjustment is required for adult patients with creatinine clearance >10 ml/min (see sections 4.2 and 5.2).
Danish: Dosisjustering er ikke nødvendig til voksne patienter med kreatininclearance >10 ml/min (se pkt.
English: HOW TO STORE DIOVAN
Danish: Diovan indeholder
English: EU/1/18/1299/001 YESCARTA
Danish: EU/1/18/1299/001 YESCARTA 0,4 x 1082 x 108 celler
English: Intravenous use bag (ethylene vinyl acetate)
Danish: Pose (ethylenvinylacetat)
English: The Decentralised Procedure, SE/H/575/07/DC, started on 1 September 2006.
Danish: Den decentrale procedure, SE/H/575/07/DC, indledtes den 1. september 2006.
English: Rapinyl and associated names
Danish: Rapinyl og tilknyttede navne
English: These Member States were not able to reach an agreement and Sweden referred the reasons for disagreement to the EMEA on 27 September 2007.
Danish: Disse medlemsstater kunne ikke nå til enighed, og Sverige indbragte grundene til uenigheden for EMEA den 27. september 2007.
English: London, 12 September 2008 EMEA/CHMP/495857/2008
Danish: London, den 12. september 2008 EMEA/CHMP/495838/2008
English: The arbitration procedure started on 18 October 2007 with the adoption of a list of questions.
Danish: Voldgiftssagen indledtes den 18. oktober 2007 med vedtagelsen af en liste med spørgsmål.
English: This refers to the bridging strategy of the Applicant and was considered to be a serious public health concern.
Danish: Dette vedrører ansøgerens overgangsstrategi og blev anset for at udgøre et alvorligt problem for folkesundheden.
English: The Applicant provided written explanations on 7 April 2008.
Danish: Ansøgeren fremsendte skriftlige redegørelser den 7. april 2008.
English: The Rapporteur was Dr Tomas Salmonson (SE) and Dr Pierre Demolis (FR) was Co-Rapporteur.
Danish: Rapportør var dr. Tomas Salmonson (S), og medrapportør var dr. Pierre Demolis (F).
English: The Reference Member State was Sweden and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain and United Kingdom.
Danish: Referencemedlemsstaten var Sverige, og de berørte medlemsstater var Østrig, Belgien, Cypern, Tjekkiet, Danmark, Estland, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Island, Irland, Italien, Letland, Litauen, Luxembourg, Norge, Polen, Portugal, Slovakiet, Slovenien, Spanien og Det Forenede Kongerige.
English: A positive opinion was adopted by consensus on 26 June 2008
Danish: Udvalget vedtog ved konsensus en positiv udtalelse den 26. juni
English: International Non-Proprietary Name (INN): fentanyl citrate
Danish: Internationalt fællesnavn (INN): fentanylcitrat
English: The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Danish: Listen over de pågældende produktnavne fremgår af bilag I. De faglige konklusioner fremgår af bilag II, og produktresuméet findes i bilag III.
English: Significant difference has been identified with regard to the need for further clinical efficacy and safety data for the evaluation of the benefit/risk and the lack of PK data under normal conditions of use of the product.
Danish: Der er konstateret en signifikant meningsforskel for så vidt angår behovet for yderligere oplysninger vedrørende den kliniske virkning og sikkerhed til belysning af benefit/risk-forholdet og manglen på farmakokinetiske data under normal brug af produktet.
English: OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR
Danish: UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 41, OM
English: During their June 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Rapinyl and associated names, that the objections raised by Germany, France, Norway and United Kingdom should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, Labelling and Package Leaflet of the Reference Member State should be amended.
Danish: Efter gennemgang af alle fremlagte oplysninger og den faglige drøftelse i udvalget vurderede CHMP på sit møde i juni 2008, at benefit/risk-forholdet for Rapinyl og tilknyttede navne er positivt, at de indvendinger, som Tyskland, Frankrig, Norge og Det Forenede Kongerige havde rejst, ikke skulle stå i vejen for udstedelse af en markedsføringstilladelse, og at produktresuméet, etiketteringen og indlægssedlen i referencemedlemsstaten skulle ændres.
English: ProStrakan Ltd submitted applications for Rapinyl and associated names, 50µg, 100µg, 200µg, 300µg, 400µg, 600µg, 800µg, sublingual tablets.
Danish: ProStrakan Ltd indgav ansøgninger for Rapinyl og tilknyttede navne, 50 µg, 100 µg, 200 µg, 300 µg, 400 µg, 600 µg, 800 µg, resoribletter, sublinguale.
English: Rapinyl and associated names, 50µg, 100µg, 200µg, 300µg, 400µg, 600µg, 800µg, sublingual tablets is indicated for the management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain.
Danish: Rapinyl og tilknyttede navne, 50 µg, 100 µg, 200 µg, 300 µg, 400 µg, 600 µg, 800 µg, resoribletter, sublinguale, er indiceret til lindring af gennembrudssmerter hos voksne patienter i opioidbehandling for kroniske cancersmerter.
English: Your doctor will discuss this with you.
Danish: Din læ ge vil diskutere det med dig.
English: Date of first authorisation: 9 February 2018 Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: 9. februar, 2018 Dato for seneste fornyelse:
English: 22014 Incheon REPUBLIC OF KOREA
Danish: 22014 Incheon SYDKOREA
English:  you have ever had any other treatment for cancer.
Danish: • du nogensinde har fået andre kræftbehandlinger.
English: This could be more serious if you are already breathless.
Danish: Dette kan blive mere alvorligt, hvis du allerede har åndenød.
English:  Risk Management Plan (RMP)
Danish: • Risikostyringsplan (RMP)
English: WestEnd Office Building B torony Hungary
Danish: WestEnd Office Building B torony Ungarn
English: Overall response rate, %
Danish: Samlet responsrate, %
English: • Heart problems can sometimes occur during treatment and occasionally after treatment has stopped and can be serious.
Danish: • Hjerteproblemer kan nogle gange forekomme under behandlingen og lejlighedsvis efter, at behandlingen er stoppet, og kan væ re alvorlige.
English: Herzuma is not recommended for anyone under the age of 18 years.
Danish: Herzuma anbefales ikke til børn og unge under 18 år.
English: The product is not intended to be stored after reconstitution and dilution unless this has taken place under controlled and validated aseptic conditions.
Danish: Produktet er ikke beregnet til at opbevares efter rekonstitution og fortynding, medmindre dette har fundet sted under kontrollerede og validerede aseptiske betingelser.
English: • Your doctor will advise you of the risks and benefits of taking Herzuma during pregnancy.
Danish: • Lægen vil rådgive dig om risiko og fordele ved at tage Herzuma under graviditeten.
English: Package leaflet: Information for the user
Danish: Indlæ gsseddel: Information til brugeren
English: Specific percentages for these are not available.
Danish: Specifikke procenter for disse er ikke tilgæ ngelige.
English: It is not known whether trastuzumab can affect reproductive capacity.
Danish: Det er ukendt, om trastuzumab kan påvirke reproduktionskapaciteten.
English: Clinical experience is limited in patients above 65 years of age.
Danish: Den kliniske erfaring er begræ nset hos patienter over 65 år.
English: A careful risk-benefit assessment should be made before deciding to treat with Herzuma.
Danish: Der skal foretages en grundig risk-benefit vurdering før det besluttes, om der skal behandles med Herzuma.
English: Do not stop using this medicine without talking to your doctor first.
Danish: Stop ikke med at bruge dette læ gemiddel uden at tale med din læ ge først.
English: The primary endpoint was overall survival which was defined as the time from the date of randomisation to the date of death from any cause.
Danish: Det primæ re endepunkt var samlet overlevelse, som blev defineret som tiden fra datoen for randomiseringen til datoen for dødsfald uanset årsag.
English: Herzuma is not genotoxic.
Danish: Herzuma er ikke genotoksisk.
English: The first dose of your treatment is given over 90 minutes and you will be observed by a health professional while it is being given in case you have any side effects.
Danish: Den første dosis af din behandling gives over 90 minutter, og du vil blive observeret af sundhedspersonale, mens den indgives, i tilfæ lde af at du får nogle bivirkninger.
English: Patients should be warned of the possibility of such a late onset and should be instructed to contact their physician if these symptoms occur.
Danish: Patienter skal advares om muligheden for dette sene frembrud og instrueres i at kontakte deres læ ge, hvis disse symptomer forekommer.
English:  you suffer from breathlessness, especially if you are currently using a taxane.
Danish: • du har åndenød, særligt hvis du i øjeblikket får et taxan.
English: All doses should be taken at the right time every week or every three weeks (depending on your dosing schedule).
Danish: Alle doser skal tages på det rigtige tidspunkt hver uge eller hver tredje uge (afhæ ngigt af dit doseringsskema).
English: The majority of the deaths were due to events related to the underlying cancer.
Danish: Størstedelen af dødsfaldene skyldtes hæ ndelser relateret til den grundliggende cancer.
English: Units 2100, 2110, 2120 and 2130 Phase 18, Central Park Bridgend Industrial Estate, Bridgend, CF31 3TY, UNITED KINGDOM
Danish: Units 2100, 2110, 2120 and 2130 Phase 18, Central Park Bridgend Industrial Estate, Bridgend, CF31 3TY, STORBRITANNIEN
English: This medicinal product must not be diluted with glucose solutions since these cause aggregation of the protein.
Danish: Dette læ gemiddel må ikke fortyndes med glucoseopløsninger da disse kan forårsage aggregation af proteinet.
English: These tissues were fixed in formalin or Bouin's fixative.
Danish: Disse væ v blev fikseret i formalin eller Bouin's fiksativ.
English: In addition, comparison of two years of trastuzumab treatment versus one year of trastuzumab treatment was performed.
Danish: Derudover blev en sammenligning af 2-års trastuzumab-behandling versus 1-års trastuzumab-behandling udført.
English: Due to non-linear elimination, total clearance increased with decreasing concentration.
Danish: Grundet ikke-lineæ r elimination steg den totale clearance ved faldende koncentration.
English: If this happens to you, contact your doctor immediately.
Danish: Hvis det sker for dig, skal du øjeblikkeligt kontakte en læ ge.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Dette læ gemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: The frequency of occurrence of hypoprothrombinemia is not known.
Danish: Hyppigheden af hypoprotrombinæmi er ikke kendt.
English: The patient who missed the dose should not wait until the next planned cycle.
Danish: Patienten, som undlod dosen, må ikke vente indtil den næ ste planlagte serie.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Danish: Det muliggør løbende overvågning af benefit/risk-forholdet for læ gemidlet.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læ s denne indlæ gsseddel grundigt, inden du begynder at bruge dette læ gemiddel, da den indeholder vigtige oplysninger.
English: Some of these symptoms can be serious and some patients have died (see section 2 under “Warnings and precautions”).
Danish: Nogle af disse sympomer kan væ re alvorlige, og nogle patienter er døde (se punkt 2 under punktet ” Advarsler og forsigtighedsregler”).
English: The number of infusions you receive will depend on how you respond to the treatment.
Danish: Antallet af infusioner, som du får, vil afhæ nge af, hvordan du reagerer på behandlingen.
English: In this section, the following categories of frequency have been used: 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 the available data).
Danish: I dette punkt er følgende kategorier for hyppighed blevet anvendt: 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 sjæ lden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenvæ rende data).
English: It should not be administered as an intravenous push or bolus.
Danish: Den må ikke administreres som intravenøs bolus.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆ TNING
English: Other side effects can occur at any time during treatment with Herzuma, not just related to an infusion.
Danish: Andre bivirkninger kan indtræ ffe på ethvert tidspunkt under behandlingen med Herzuma, og som ikke kun er relateret til en infusion.
English: *Cmin,ss = Cmin at steady state **Cmax,ss = Cmax at steady state *** time to 90% of steady state
Danish: ved steady state **Cmax,ss = Cmax ved steady state ***Tid til 90 % af steady state
English: The majority of these events occur during or within 2.5 hours of the start of the first infusion.
Danish: Størstedelen af disse hæ ndelser forekommer under eller inden for 2,5 timer efter påbegyndelse af den første infusion.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Danish: 4.5 Interaktion med andre læ gemidler og andre former for interaktion
English: Other side effects that have been reported with Herzuma use (frequency cannot be estimated from the available data):
Danish: Andre bivirkninger som er blevet rapporteret ved brug af Herzuma (hyppighed kan ikke estimeres ud fra forhåndenvæ rende data)
English: You can help by reporting any side effects you may get.
Danish: Du kan hjæ lpe ved at indberette alle de bivirkninger, du får.
English: Biotech Services International Limited Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend
Danish: Biotec Services International Limited Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend
English: As animal reproduction studies are not always predictive of human response, trastuzumab should be avoided during pregnancy unless the potential benefit for the mother outweighs the potential risk to the foetus.
Danish: Da reproduktionsstudier på dyr ikke altid er præ diktive for mennesker, bør trastuzumab undgås under graviditeten med mindre den potentielle fordel for moderen opvejer den potentielle risiko for fostret.
English: Your doctor will closely supervise your therapy.
Danish: Din læ ge vil nøje overvåge din behandling.
English: Therefore your doctor may decide to continue to check your heart functions, even after you finish treatment.
Danish: Derfor kan din læ ge beslutte at fortsæ tte med at undersøge din hjertefunktion, efter din behandling er stoppet.
English: Use of other reconstitution solvents should be avoided.
Danish: Brug af andre rekonstitutionsopløsninger bør undgås.
English: Time to disease progression, median months
Danish: Tid til sygdomsprogression, Median måneder
English: For monotherapy, the rate was 6% - 9%.
Danish: Ved monoterapi var frekvensen 6 - 9 %.
English: Allow the vial to stand undisturbed for approximately 5 minutes.
Danish: Lad hæ tteglasset stå i ro i ca. 5 minutter.
English: Herzuma may affect your ability to drive a car or operate machines.
Danish: Herzuma kan påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: For instructions on reconstitution of Herzuma intravenous formulation before administration, see section 6.6.
Danish: For instruktioner om rekonstitution af Herzuma intravenøs formulering før administration, se pkt.
English: Your doctor will prescribe a dose and treatment regimen that is right for you.
Danish: Din læ ge vil ordinere en dosis og en behandlingsmåde, som passer til dig.
English: Herzuma may also be given once a week for metastatic breast cancer.
Danish: Herzuma kan også gives én gang om ugen ved metastatisk brystkræ ft.
English: Therefore, these patients should not be treated with Herzuma (see section 4.3).
Danish: Disse patienter bør derfor ikke behandles med Herzuma (se pkt.
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
Danish: • Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læ ge, apotekspersonalet eller sundhedspersonalet til råds, før du tager dette læ gemiddel.
English: Patients may continue therapy during periods of reversible, chemotherapy-induced myelosuppression but they should be monitored carefully for complications of neutropenia during this time.
Danish: Patienterne kan fortsæ tte behandlingen i perioder med reversibel, kemoterapi-induceret suppression af knoglemarven, men de skal monitoreres omhyggeligt for komplikationer relateret til neutropeni i denne periode.
English:  you have severe breathing problems at rest due to your cancer or if you need oxygen treatment.
Danish: • du har alvorlige problemer med at trække vejret på grund af din cancer eller hvis du har behov for behandling med ilt.
English: If you stop using Herzuma
Danish: Hvis du holder op med at bruge Herzuma
English: Bridgend Industrial Estate Bridgend, CF31 3RT United Kingdom
Danish: Bridgend Industrial Estate Bridgend, CF31 3RT Storbritannien
English: Herzuma should only be given by a doctor or nurse.
Danish: Herzuma må kun gives af en læ ge eller sygeplejerske.
English: which was followed by
Danish: som blev efterfulgt af:
English: No incompatibilities between Herzuma and polyvinylchloride, polyethylene or polypropylene bags have been observed.
Danish: Der er ikke set uforligeligheder mellem Herzuma og polyvinylchlorid-, polyethylen- eller polypropylenposer.
English: No long-term animal studies have been performed to establish the carcinogenic potential of Herzuma, or to determine its effects on fertility in males.
Danish: Der er ikke udført langtidsdyrestudier for at fastslå Herzumas carcinogene potentiale eller bestemme dets virkning på fertilitet hos hanner.
English: Slight foaming of the product upon reconstitution is not unusual.
Danish: Let skumdannelse ved rekonstitutionen er ikke ualmindelig.
English: Subsequent maintenance doses should be administered 7 days or 21 days later according to the weekly or threeweekly schedules, respectively.
Danish: Efterfølgende vedligeholdelsesdoser bør administreres 7 eller 21 dage senere i henhold til henholdvis ugentlige eller 3-ugers doseringsregimer.
English: This medicine is subject to additional monitoring.
Danish: Dette læ gemiddel er underlagt supplerende overvågning.
English: Before starting the treatment your doctor will determine the amount of HER2 in your tumour.
Danish: Inden din behandling påbegyndes, vil læ gen bestemme mæ ngden af HER2 i din tumor.
English: Herzuma loading dose should be administered as a 90-minute intravenous infusion.
Danish: En støddosis af Herzuma bør administreres som en 90 minutters intravenøs infusion.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg din læ ge eller apotekspersonalet til råds, inden du tager nogen form for medicin.
English: Trastuzumab can cause breathing difficulties, especially when it is first given.
Danish: Trastuzumab kan forårsage vejrtræ kningsproblemer, specielt når det gives første gang.
English: In the pivotal trial (BO16216), trastuzumab and anastrozole were administered from day 1.
Danish: I det pivotale studie (BO16216) blev trastuzumab og anastrozol administreret fra dag 1.
English: Acute respiratory distress syndrome Not known Bronchospasm
Danish: Akut respiratorisk distress syndrom Ikke kendt Bronkospasmer
English: Taking into account the PRAC Assessment Report on the PSUR(s) for trastuzumab, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for trastuzumab er CHMP nået frem til følgende videnskabelige konklusioner:
English: In the pivotal trial of docetaxel (100 mg/m infused over
Danish: I det pivotale studie med docetaxel (100 mg/m infunderet over
English: These medicines (or any other anthracyclines) can damage heart muscle and increase the risk of heart problems with trastuzumab.
Danish: Disse læ gemidler (og ethvert andet antracyklin) kan skade hjertet og øge risikoen for hjerteproblemer sammen med trastuzumab.