FrancophonIA/ELRC3.0 huggingface dataset:
English: There is a risk of a build-up of hard, dry stool, particularly if Ispaghula husk is swallowed without enough liquid.
Danish: Der er risiko for dannelse af hård, tør afføring, navnlig hvis ispaghula-frøskaller tages med for lidt væske.
English: It moves down the digestive system and makes the stools softer by increasing their water content.
Danish: Det føres gennem fordøjelsessystemet og gør afføringen blødere ved at øge vandindholdet.
English: Its effectiveness in softening stools has been shown in a number of studies comparing ispaghula husk with placebo (a dummy treatment) in patients with haemorrhoids.
Danish: Deres effektivitet til at blødgøre afføringen er påvist i en række undersøgelser, hvor ispaghula-frøskaller blev sammenlignet med placebo (en virkningsløs behandling) hos patienter med hæmorroider.
English: Any applications for the licensing of medicines containing ispaghula husk have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder ispaghula-frøskaller, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: By increasing the stool bulk it also increases the tension in the bowel wall which will trigger bowel movements.
Danish: Ved at øge afføringens volumen, øges desuden spændingen i tarmvæggen og sætter derved gang i tarmbevægelserne.
English: Information on the use and licensing of ispaghula husk medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om anvendelse og godkendelse i EU's medlemsstater af lægemidler, der indeholder ispaghula-frøskaller, skal indhentes fra de relevante nationale myndigheder.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing ispaghula husk.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder ispaghula-frøskaller.
English: In its assessment of ispaghula husk to treat constipation, the HMPC considered a number of clinical studies involving over 900 patients that showed the effectiveness of ispaghula husk as a mild laxative.
Danish: I sin vurdering af ispaghula-frøskaller til behandling af forstoppelse gennemgik HMPC en række kliniske undersøgelser med over 900 patienter, der viste, at ispaghula-frøskaller er effektive som mildt afføringsmiddel.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of ispaghula husk.
Danish: Dette er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner om den medicinske anvendelse af ispaghula-frøskaller.
English: Further information on the HMPC assessment of ispaghula husk medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder ispaghula-frøskaller, herunder detaljerede oplysninger om udvalgets konklusioner, findes under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the risks associated with ispaghula husk medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler, der indeholder ispaghula-frøskaller, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Allergic reactions including rhinitis (runny nose), conjunctivitis (reddening and inflammation of the white of the eye), bronchospasm (excessive and prolonged contraction of the airway muscles) and anaphylaxis (severe allergic reaction) may also occur.
Danish: Desuden kan der forekomme allergiske reaktioneri form af af løbende næse (rhinitis), røde og irriterede øjne (konjunktivitis), vejrtækningsbesvær (bronkospasme) og svær allergisk reaktion (anafylaksi).
English: Herbal medicines containing ispaghula husk are usually available in solid forms to be taken by mouth.
Danish: Plantelægemidler med ispaghula-frøskaller fås normalt i fast form til indtagelse gennem munden.
English: The way ispaghula husk works in reducing blood cholesterol levels is not fully understood.
Danish: Den nøjagtige måde, hvorpå ispaghula-frøskaller nedsætter kolesterolindholdet, er ikke fuldstændig kendt.
English: The HMPC conclusions on the use of ispaghula husk medicines are based on their ‘well-established use' in these conditions.
Danish: HMPC's konklusioner om anvendelsen af lægemidler med ispaghula-frøskaller bygger på den "almindeligt anerkendte anvendelse".
English: Ispaghula husk
Danish: Ispaghula-frøskaller
English: Ispaghula husk should be taken with plenty of liquid.
Danish: Ispaghula-frøskaller skal indtages med rigelig væske.
English: It should also not be used in patients with conditions that involve a narrowing of the stomach and gut, and patients who have difficulty swallowing or have problems with their throat.
Danish: Det bør heller ikke anvendes hos patienter med sygdomme, der medfører forsnævring i mave-tarm-systemet., eller hos patienter med halsproblemer eller vanskeligheder ved at synke.
English: The HMPC concluded that ispaghula husk can be used for the treatment of habitual constipation (constipation not caused by a physical change to an organ) and in conditions where softening of the stools is desirable to reduce pain when they are passed, such as anal fissures, haemorrhoids and after surgery to the anus or rectum.
Danish: HMPC konkluderede, at ispaghula-frøskaller kan anvendes til behandling af ofte tilbagevendende forstoppelse ( der ikke skyldes en fysisk ændring i et organ) og ved tilstande, hvor det ønskes at blødgøre afføringen for at nedsætte smerter ved passage, såsom rifter i endetarmsåbningen (analfissurer) og hæmorroider samt efter operationer i endetarmen og eller tarmåbningen.
English: The HMPC also concluded that ispaghula husk can be used in people where an increase in the daily intake of dietary fibre may be advisable, such as patients with irritable bowel syndrome who are suffering from constipation or in combination with diet in patients with hypercholesterolaemia (high blood cholesterol levels).
Danish: HMPC konkluderede desuden, at ispaghula-frøskaller kan anvendes, når der er behov for øget daglig indtagelse af kostfibre, som f.eks. hos patienter med forstoppelse på grund af irritabel tyktarm, eller i kombination med diæt ved forhøjet kolesterolindhold i blodet(hyperkolesterolæmi).
English: This summary is not intended to provide practical advice on how to use medicines containing ispaghula husk.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder ispaghula-frøskaller, anvendes.
English: How does ispaghula husk work as a medicine?
Danish: Hvordan virker ispaghula-frøskaller som lægemiddel?
English: Other information about ispaghula husk medicines
Danish: Andre oplysninger om lægemidler, der indeholder ispaghula-frøskaller
English: The use of ispaghula husk in hypercholesterolaemia always requires medical supervision.
Danish: Anvendelse af ispaghula-frøskaller ved forhøjet kolesterol skal altid foregå i samråd med læge.
English: Ispaghula husk contains dietary fibre, which when mixed with water forms a gel-like mass that works as a mild laxative (medicine used to treat constipation).
Danish: Ispaghula-frøskaller indeholder kostfibre, som ved opblanding med vand danner en geléagtig masse, der virker som et mildt afføringsmiddel.
English: Detailed instruction on how to take ispaghula husk medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger for, hvordan lægemidler medispaghula-frøskaller skal anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: The HMPC recommended that ispaghula husk should not be used in patients with a sudden change in bowel habit that persists for more than two weeks, and in patients with undiagnosed bleeding of the rectum and failure to pass stools following the use of a laxative.
Danish: HMPC anbefaler, at lægemidler med ispaghula-frøskaller ikke anvendes til patienter med pludseligt ændrede afføringsvaner, der varer i mere end to uger; eller til patienter der af ukendt årsag har blødning fra endetarmen; eller manglende evne til at komme af med afføringen efter brug af afføringsmiddel.
English: How are ispaghula husk medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder ispaghula-frøskaller, i EU?
English: What evidence supports the use of ispaghula husk medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af ispaghula-frøskaller?
English: For more information about treatment with ispaghula husk medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder ispaghula-frøskaller, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: Side effects have been reported with ispaghula husk medicines, including flatulence and abdominal distension (swelling of the belly).
Danish: Ved brug af lægemidler med isphagula-frøskaller er beskrevet bivirkninger, herunder tarmluft og og oppustethed.
English: For practical information about using ispaghula husk medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidler med ispaghula-frøskaller, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: Several studies investigated the effects of ispaghula husk on blood cholesterol levels and found that treatment with ispaghula husk led to small reductions in blood cholesterol levels.
Danish: En række undersøgelser har endvidere vist, at behandling med ispaghula-frøskaller medførte en mindre reduktion i blodets kolesterolindhold.
English: What are the risks associated with Ispaghula husk medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder ispaghulafrøskaller?
English: What is Ispaghula husk?
Danish: Hvad er ispaghula-frøskaller?
English: It can be used in adults and children above the age of 6 years for the treatment of constipation and to soften the stools but should only be used in adults and children over the age of 12 years when used to increase the fibre intake.
Danish: Til behandling af forstoppelse og til at blødgøre afføringen kan isphagula-frøskaller anvendes af voksne og børn over seks år.
English: Ispaghula husk is used without further processing or as preparations obtained by powdering the seed coats.
Danish: Ispaghula-frøskaller anvendes i deres naturlige form eller forarbejdes ved pulverisering af frøskallerne.
English: 15 March 2012
Danish: Den 15. marts 2012
English: The application was withdrawn after ‘day 90'.
Danish: Ansøgningen blev trukket tilbage efter "dag 90".
English: Tyverb has been authorised in the EU since June 2008.
Danish: Tyverb har været godkendt i EU siden juni 2008.
English: A comparative study would have addressed this issue.
Danish: En sammenlignende undersøgelse ville have afklaret til dette spørgsmål.
English: The full European Public Assessment Report for Tyverb can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige europæiske offentlige vurderingsrapport for Tyverb findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Tyverb?
Danish: Hvad er Tyverb?
English: It is available as tablets.
Danish: Det leveres som tabletter.
English: The main measure of effectiveness was overall survival (the length of time the patients lived).
Danish: Behandlingens virkning blev hovedsagelig bedømt på den totale overlevelse (hvor længe patienterne levede).
English: Tyverb is available in all EU Member States.
Danish: Tyverb er godkendt i alle i EU's medlemsstater.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse med Tyverb og har behov for mere information om din behandling, bedes du kontakte den læge, der giver dig behandlingen.
English: Tyverb is used when the cancer is advanced or metastatic.
Danish: Tyverb anvendes, når kræften er fremskreden eller metastatisk.
English: What was Tyverb expected to be used for?
Danish: Hvad forventedes Tyverb anvendt til?
English: It has been granted ‘conditional' marketing authorisation because there is more evidence to come about the medicine.
Danish: Det har fået udstedt markedsføringstilladelse ”under særlige omstændigheder”, fordi der forventes yderligere dokumentation for lægemidlet.
English: HER2 is a receptor for epidermal growth factor and is involved in stimulating the cells to divide uncontrollably.
Danish: HER2 er en receptor for epidermal vækstfaktor og stimulerer cellerne til at dele sig ukontrolleret.
English: Tyverb is a medicine that contains the active substance lapatinib.
Danish: Tyverb er et lægemiddel, der indeholder det aktive stof lapatinib.
English: The company presented data from one main study involving a total of 444 patients with metastatic breast cancer that was expressing large quantities of HER2.
Danish: Virksomheden fremlagde data fra én hovedundersøgelse, der omfattede i alt 444 patienter med metastatisk brystkræft, der udtrykte store mængder af HER2.
English: How is Tyverb expected to work?
Danish: Hvordan forventes Tyverb at virke?
English: By blocking these receptors, Tyverb helps to control cell division.
Danish: Ved at blokere disse receptorer begrænser Tyverb cellernes deling.
English: Tyverb in combination with paclitaxel is expected to work in the same way as it does in its existing indication.
Danish: Tyverb forventes at virke på samme måde i kombination med Paclitaxel, som det gør til den eksisterende indikation.
English: There are no consequences on the use of Tyverb in its authorised indications.
Danish: Afgørelsen vil ikke få konsekvenser for anvendelsen af Tyverb til de godkendte indikationer.
English: In particular, the Committee could not exclude the possibility that Tyverb in combination with paclitaxel is inferior to the standard treatment, trastuzumab plus paclitaxel.
Danish: Navnlig kunne udvalget ikke udelukke den mulighed, at Tyverb i kombination med paclitaxel virker dårligere end standardbehandlingen, som er trastuzumab plus paclitaxel.
English: This means that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Danish: Det betyder, at CHMP havde vurderet den dokumentation, virksomheden havde indsendt, og stillet en række spørgsmål.
English: On 15 February 2012, Glaxo Group Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Tyverb, to add the use in combination with paclitaxel for the treatment of metastatic breast cancer.
Danish: Den 15. februar 2012 meddelte Glaxo Group Ltd. officielt til Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om ændring af markedsføringstilladelsen for Tyverb med henblik på tilføjelse af anvendelsen af Tyverb i kombination med paclitaxel til behandling af metastatisk brystkræft.
English: The active substance in Tyverb, lapatinib, belongs to a group of medicines called protein kinase inhibitors.
Danish: Det aktive stof i Tyverb, lapatinib, tilhører en gruppe lægemidler, der kaldes proteinkinasehæmmere.
English: After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues.
Danish: Efter at CHMP havde vurderet virksomhedens besvarelse af spørgsmålene, var der stadig nogle uafklarede punkter.
English: The CHMP was concerned that the main study, which compared Tyverb with placebo, did not allow the Committee to conclude on how Tyverb compares with other authorised treatments.
Danish: CHMP var betænkelig ved, at hovedundersøgelsen, hvor Tyverb blev sammenlignet med placebo, ikke gav udvalget tilstrækkelig mulighed for at bedømme, hvordan Tyverb virker i sammenligning med andre godkendte behandlinger.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Tyverb at this time.
Danish: Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Tyverb.
English: ‘Advanced' means that the cancer has started to spread and ‘metastatic' means that the cancer has already spread to other parts of the body.
Danish: At den er ”metastatisk” vil sige, at kræften allerede har bredt sig til andre dele af kroppen.
English: This means that the cancer produces a specific protein called HER2 (also known as ErbB2) in large quantities on the surface of the tumour cells.
Danish: Herved forstås, at kræften producerer store mængder af et særligt protein, HER2 (betegnes også ErbB2) på overfladen af svulstcellerne.
English: About a quarter of breast cancers express HER2.
Danish: Ekspression af HER2 findes ved omkring en fjerdedel af alle brystkræfttilfælde.
English: Tyverb is used in combination with capecitabine or with an aromatase inhibitor (other anticancer medicines) to treat patients with breast cancer that has been shown to be ‘expressing' large amounts of HER2.
Danish: Tyverb anvendes i kombination med capecitabin eller med en aromatasehæmmer (andre lægemidler mod kræft) til behandling af brystkræft, der ”udtrykker” store mængder HER2.
English: Tyverb was also expected to be used in combination with paclitaxel (another anticancer medicine) for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2.
Danish: Tyverb forventedes også anvendt i kombination med paclitaxel (et andet lægemiddel mod kræft) til behandling af metastatisk brystkræft, hvor svulsten har overekspression af HER2.
English: These compounds work by blocking enzymes known as protein kinases, which can be found in some receptors on the surface of cancer cells including HER2.
Danish: Proteinkinaser er enzymer, der findes i visse receptorer på overfladen af kræftceller, herunder HER2.
English: What is happening with Tyverb used in combination with capecitabine or with an aromatase inhibitor?
Danish: Hvilke konsekvenser vil afgørelsen få for anvendelsen af Tyverb i kombination med capecitabin eller med en aromatasehæmmer?
English: In its letter notifying the Agency of the withdrawal of application, the company stated that its decision to withdraw the application was based on the CHMP's assessment that the lack of a study comparing Tyverb with another treatment hampered the proper assessment of the benefit-risk balance in European patients in the applied indication.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at tilbagetrækningen skyldtes CHMP's konklusion om, at der savnedes en undersøgelse, hvor Tyverb sammenlignes med en anden behandling, og om, at det derfor var vanskeligt at vurdere forholdet mellem fordele og risici hos europæiske patienter til den ansøgte indikation.
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 Tyverb eller i programmer for anvendelse af Tyverb med særlig udleveringstilladelse?
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not addressed its concerns and that the benefit-risk balance of Tyverb in combination with paclitaxel for the treatment of metastatic breast cancer could not be properly assessed.
Danish: Derfor var CHMP på tilbagetrækningstidspunktet af den opfattelse, at virksomheden ikke havde imødekommet udvalgets betænkeligheder, og at det ikke i tilstrækkelig grad var muligt at vurdere forholdet mellem fordele og risici for Tyverb i kombination med paclitaxel til behandling af metastatisk brystkræft.
English: The study compared Tyverb with placebo (a dummy treatment), both of which were taken together with paclitaxel.
Danish: I undersøgelsen blev Tyverb sammenlignet med placebo (virkningsløs behandling).
English: The CHMP was assessing the company's responses to the questions at the time of the withdrawal.
Danish: På tidspunktet for tilbagetrækningen var CHMP i færd med at vurdere virksomhedens besvarelse af spørgsmålene.
English: The recommended dose is
Danish: Den anbefalede dosis er
English: How does the test work?
Danish: Hvordan fungerer testen?
English: Your doctor now wishes to find out if the treatment has been successful.
Danish: Lægen ønsker nu at få fastslået, om behandlingen er lykkedes.
English: Date of first authorisation: 14 August 1997 Date of latest renewal: 14 August 2007
Danish: Dato for første markedsføringstilladelse: 14. august 1997 Dato for seneste fornyelse: 14. august 2007
English: No concerns in relation to the clinical use of the product.
Danish: Ingen forbehold vedrørende klinisk brug af produktet.
English: • Helicobacter pylori (see section 3, second paragraph under “Method of use”)
Danish: • Helicobacter pylori (se punkt 3, anden paragraf under “Anvendelsesmåde”)
English: No side effects are known.
Danish: Der er ingen kendte bivirkninger.
English: • 4 weeks after a therapy against a bacterial infection
Danish: • 4 uger efter behandling mod en bakteriel infektion
English: Pour the contents into a drinking glass.
Danish: Indholdet hældes i et drikkeglas.
English: Therefore the test shall be used after at least four weeks without systemic antibacterial therapy and two weeks after last dose of acid antisecretory agents.
Danish: Derfor skal testen udføres efter mindst 4 uger uden systemisk antibakteriel behandling og 2 uger efter sidste dosis af syresekretionshæmmende midler.
English: • Risk Management Plan (RMP)
Danish: Risikostyringsplan (RMP)
English: The test should be performed following at least:
Danish: Testen skal først udføres mindst:
English: Stability:
Danish: Stabilitet:
English: Absorption and distribution of 13CO2 is faster than the urease reaction.
Danish: Absorption og distribution af 13CO2 er hurtigere end urease reaktionen.
English: Alternatively, any other suitable-validated method may be used, carried out by any objectively qualified laboratory.
Danish: Alternativt kan enhver anden egnet valideringsmetode udført af ethvert objektivt kvalificeret laboratorium benyttes.
English: Doctor/Hospital Address
Danish: Lægens/hospitalets adresse
English: Linearity:
Danish: Linearitet:
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid eller planlægger at blive gravid, skal De spørge lægen eller apotekspersonalet til råds, før De tager dette lægemiddel.
English: These are required to check for the presence of any other complications, such as:
Danish: Disse undersøgelser er nødvendige for udelukke andre komplikationer, som f.eks.: