FrancophonIA/ELRC3.0 huggingface dataset:
English: • gastrointestinal stromal tumour (GIST, a cancer of the stomach and bowel) that has spread or cannot be surgically removed;
Danish: • gastrointestinale stromale tumorer (GIST - en form for kræft i mave og tarm), som har spredt sig, eller som ikke kan fjernes ved operation.
English: However, given the side effects, the CHMP considered it important to find ways to identify any subgroups of patients who are more likely to respond to Stivarga.
Danish: På baggrund af bivirkningerne fandt CHMP det dog nødvendigt at finde en metode til at fastlægge eventuelle undergrupper af patienter, hos hvem Stivarga har større sandsynlighed for at virke.
English: Stivarga had been shown to delay the worsening of the disease in these patients.
Danish: Det er påvist, at Stivarga sinker forværringen af sygdommen hos disse patienter.
English: Patients treated with Stivarga lived on average for 4.8 months without their disease getting worse compared with 0.9 months for patients taking placebo and supportive care.
Danish: De patienter, der blev behandlet med Stivarga, overlevede i gennemsnit 4,8 måneder uden forværring af deres sygdom sammenholdt med 0,9 måneder for de patienter, der fik placebo og støttebehandling.
English: How is Stivarga used?
Danish: Hvordan anvendes Stivarga?
English: For practical information about using Stivarga, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Stivarga, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The most serious side effects are severe liver injury, bleeding, gastrointestinal perforation (development of a hole in the wall of the gut) and infection.
Danish: De alvorligste bivirkninger er svær leverskade, blødning, tarmperforation (hul i tarmvæggen) og infektion.
English: Patients with GIST should have tried treatment with imatinib and sunitinib and patients with HCC should have tried sorafenib before starting treatment with Stivarga.
Danish: Patienter med gastrointestinale stromale tumorer bør have fået behandling med imatinib og sunitinib, og patienter med hepatocellulært karcinom bør have fået sorafenib inden påbegyndelse af behandling med Stivarga.
English: • hepatocellular carcinoma (HCC, a cancer of the liver).
Danish: • hepatocellulært karcinom (en type kræft i leveren).
English: What benefits of Stivarga have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Stivarga?
English: The active substance in Stivarga, regorafenib, is a ‘protein kinase inhibitor'.
Danish: Det aktive stof i Stivarga, regorafenib, er en såkaldt proteinkinasehæmmer.
English: In another main study, Stivarga was compared with placebo in 199 patients with GIST that had spread or was inoperable and who were also given best supportive care.
Danish: I en anden hovedundersøgelse blev Stivarga sammenlignet med placebo hos 199 patienter med gastrointestinale stromale tumorer, der havde spredt sig eller ikke kunne fjernes ved operation, og som fik den bedste støttebehandling.
English: In a main study involving 760 patients with metastatic colorectal cancer which had progressed after standard therapy, Stivarga was compared with placebo (a dummy treatment) and the main measure of effectiveness was overall survival (the length of time that patients lived).
Danish: I en hovedundersøgelse, der omfattede 760 patienter med metastatisk kolorektal cancer, som var skredet frem efter standardbehandling, blev Stivarga sammenlignet med placebo (en uvirksom behandling), og virkningen blev hovedsagelig målt på den samlede overlevelse (hvor længe patienterne overlevede).
English: With regard to GIST and HCC, the Committee noted that the outlook is poor for patients whose disease gets worse despite previous treatment.
Danish: Hvad angår gastrointestinale stromale tumorer og hepatocellulært karcinom, bemærkede udvalget, at der er ringe udsigter for patienter, hvis sygdom forværres til trods for tidligere behandling.
English: The study showed that Stivarga improved survival, with treated patients living for 6.4 months on average, compared with 5 months for those given placebo.
Danish: Undersøgelsen viste, at Stivarga forbedrede overlevelsen, idet de behandlede patienter i gennemsnit levede i 6,4 måneder sammenholdt med 5 måneder for dem, der fik placebo.
English: In a main study involving 573 patients with HCC that had worsened after treatment with sorafenib, Stivarga was compared with placebo and the main measure of effectiveness was overall survival.
Danish: I en hovedundersøgelse med 573 patienter med hepatocellulært karcinom, som var forværret efter behandling med sorafenib, blev Stivarga sammenholdt med placebo, og virkningen blev hovedsagelig målt på den samlede overlevelse.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Stivarga have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Stivarga.
English: The study showed that Stivarga increased the length of time that patients lived overall, with patients treated with Stivarga living for 10.6 months on average, compared with 7.8 months for those given placebo.
Danish: Undersøgelsen viste, at Stivarga samlet set øgede den tid, som patienterne overlevede, idet de patienter, der fik Stivarga, i gennemsnit overlevede i 10,6 måneder, mens dem, der fik placebo, overlevede i 7,8 måneder.
English: Treatment may need to be interrupted or stopped, or the dose reduced, if the patient experiences certain side effects.
Danish: Hvis patienten mærker visse bivirkninger, kan det være nødvendigt at afbryde behandlingen eller nedsætte dosis.
English: For patients with HCC, this led to an improvement in the length of time patients lived.
Danish: For patienter med hepatocellulært karcinom medførte dette en forlængelse af patienternes overlevelsestid.
English: How does Stivarga work?
Danish: Hvordan virker Stivarga?
English: Definitions
Danish: Videnskabelige konklusioner
English: 30 November 2018 EMA/776723/2017 rev. 1**
Danish: 30. januar 2019
English: The use of a highly glossy or metallic reflective colour is not recommended as it may affect clarity.
Danish: Der blev ikke observeret noget akkumuleringsmønster eller fortsat stigning i magnesiumniveauer i serum, der kunne give grund til bekymring om sikkerheden.
English: SECTION 1
Danish: 1. december 2018
English: Annex 1 - Approved pictograms
Danish: Bilag II Betingelser for markedsføringstilladelsen/-tilladelserne
English: Target species:
Danish: Vedtagelse af CMDh's indstilling:
English: Variation classification guideline 2013/C 223/01: link
Danish: CMDh-møde i oktober 2018
English: Mechanism to introduce pictograms from Annex 1
Danish: Bilag III Tidsplan for implementering af denne indstilling
English: Pictograms should exclude any element of a promotional nature.
Danish: Der blev ikke identificeret potentielle risikofaktorer for betydningsfuld stigning i serummagnesium.
English: For authorised products, requests to make use of pictograms from Annex 1 can be made during a post-authorisation procedure affecting the product information when the product information is ‘open' for review.
Danish: På baggrund af tilgængelige data vedrørende den endelige PASS-studierapport vurderede PRAC derfor, at ændringer i betingelserne for markedsføringstilladelsen var berettigede.
English: Marketing authorisation holders (MAH) must make best use of the available space on the packaging to ensure that all the information is clear and legible, taking into consideration the typical environments or situations in which the product will be used.
Danish: Indehaveren/indehaverne af markedsføringstilladelsen skal fjerne følgende betingelse(r) (ny tekst med understregning og fed skrift, slettet tekst med gennemstregning)
English: New pictograms (currently limited to the category of target species), should be proposed and endorsed within industry associations where possible and then submitted to both the CMDv and QRD secretariats for regulatory approval: CMDv@ema.europa.eu and qrd@ema.europa.eu.
Danish: Den endelige rapport for det deskriptive studie indsendt af indehaveren af markedsføringstilladelsen, overholder forpligtelsen til at udføre en prospektiv ikke-interventionssikkerhedsundersøgelse efter tilladelse til markedsføring (PASS) for yderligere at evaluere magnesiumniveauer observeret hos fuldbårne nyfødte spædbørn og børn op til to år behandlet efter rutinemæssig klinisk praksis som pålagt i henhold til artikel 107i procedure EMEA/H/A-107i/1373 for produkter der indeholder alanin, arginin, asparaginsyre, cystein, glucose, glutaminsyre, glycin, histidin, isoleucin, leucin, lysinmonohydrat, methionin, ornithinhydrochlorid, phenylalanin, prolin, serin, taurin, threonin, tryptophan, tyrosin, valin, calciumchlorid, magnesiumacetat, kaliumacetat, natriumchlorid, natriumglycerophosphat, raffineret sojabønneolie, raffineret olivenolie.
English: Pictograms may not be less than 5 mm in height, which may be waived in exceptional circumstances for very small packs; the approval of pictograms smaller than 5 mm in height will be a matter for assessment on a case-by-case basis.
Danish: Samlet set tyder data på, at nyfødte i en kort periode kan tolerere en relativt bred vifte af serummagnesiumkoncentrationer uden øget risiko for negative resultater.
English: For new marketing authorisation applications, any proposed use of pictograms from Annex 1 should be indicated in the product information within the initial submission or as soon as possible during the ongoing procedure.
Danish: Indehaveren af markedsføringstilladelse forelægger protokollen til ovennævnte undersøgelse.
English: Introduction
Danish: Tidsplan for implementering af denne indstilling
English: General characteristics of pictograms
Danish: CMDh tilslutter sig PRAC's videnskabelige konklusioner.
English: The new approved pictograms will be added periodically to the annexes of this guidance.
Danish: Oversættelser af bilagene for indstillingen fremsendes til de relevante nationale myndigheder:
English: The use of pictograms from Annex 1 as defined in this guidance will apply to the national authorisation procedures, including MRP and DCP, as well as to the centralised procedure .
Danish: Indehaveren af markedsføringstilladelsen udfører en prospektiv, ikke-interventionel sikkerhedsundersøgelse efter markedsføring til yderligere vurdering af de iagttagne magnesiumværdier hos nyfødte og børn op til to år, der behandles med Numeta G16%E i rutinemæssig klinisk praksis.
English: The size of the pictograms should be proportionate to the overall size of the printed material.
Danish: Niveauerne af magnesium i disse tilfælde anses ikke for at udgøre klinisk relevant hypermagnesæmi.
English: The aim of the guidance is to outline the approval requirements and process for two situations where either:
Danish: Begrundelser for ændring af betingelserne for markedsføringstilladelsen/-tilladelserne
English: In order to indicate its intended use to assessors, any pictogram should be inserted within the product information, as follows:
Danish: Indstillingen implementeres i medlemsstaterne (indehaveren af markedsføringstilladelsen indsender variationsansøgning):
English: In particular for target species, pictograms cannot be used to replace text such as the age, sex or size of the animal, therefore pictograms will always represent the species and not the sub-species.
Danish: På baggrund af de videnskabelige konklusioner for resultaterne af studiet for lægemiddel/lægemidler indeholdende det aktive stof alanin, arginin, asparaginsyre, cystein, glucose, glutaminsyre, glycin, histidin, isoleucin, leucin, lysinmonohydrat, methionin, ornithinhydrochlorid, phenylalanin, prolin, serin, taurin, threonin, tryptophan, tyrosin, valin, calciumchlorid, magnesiumacetat, kaliumacetat, natriumchlorid, natriumglycerophosphat, raffineret sojabønneolie, raffineret olivenolie og omfattet af den endelige PASS-rapport, er CMDh af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, nævnt ovenfor, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: ** Camel, Fox, Pigeon and Reindeer pictograms have been included.
Danish: Ændringer af betingelserne for markedsføringstilladelsen for lægemidler med indhold af det aktive stof alanin, arginin, asparaginsyre, cystein, glucose, glutaminsyre, glycin, histidin, isoleucin, leucin, lysinmonohydrat, methionin, ornithinhydrochlorid, phenylalanin, prolin, serin, taurin, threonin, tryptophan, tyrosin, valin, calciumchlorid, magnesiumacetat, kaliumacetat, natriumchlorid, natriumglycerophosphat, raffineret sojabønneolie, raffineret olivenolie berørt af den pålagte ikke-interventionelle endelige PASS-rapport
English: If pictograms are used to substitute text on the packaging, it is compulsory to use those provided in section 1 of Annex 1 i.e. the use of proprietary pictograms not in this ‘catalogue' is not approvable in the case of substitution of text.
Danish: CMDh er nået frem til, at markedsføringstilladelsen/-tilladelserne omfattet af denne endelige PASSrapport bør ændres.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus L4 on 31 July 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Versican Plus L4 den 31. juli 2014.
English: The effectiveness of Versican Plus L4 was investigated in a field study involving 129 dogs.
Danish: Effektiviteten af Versican Plus L4 blev undersøgt i en feltundersøgelse med 129 hunde.
English: the future, if the animals are exposed to these Leptospira bacteria the immune system will be able to respond more quickly.
Danish: Hvis dyret efterfølgende udsættes for disse Leptospira-bakterier, vil immunsystemet reagere hurtigere.
English: The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus L4 is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination.
Danish: Den hyppigste bivirkning (som optræder hos mere end 1 ud af 100 hunde) med Versican Plus L4 er kortvarig hævelse på op til 5 cm, der kan forekomme på injektionsstedet efter vaccinationen.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus L4 exceed the risks for the approved indication and recommended that Versican Plus L4 be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Versican Plus L4 overstiger risiciene til den godkendte anvendelse, og anbefalede udstedelse af en markedsføringstilladelse for Versican Plus L4.
English: This will help protect them against leptospirosis.
Danish: Derved opnås bedre beskyttelse mod leptospirose.
English: The strains of Leptospira bacteria in Versican Plus L4 are killed (inactivated) so that they do not cause disease.
Danish: Stammerne af Leptospirabakterier i Versican Plus L4 er inaktiveret (dræbt), så de ikke kan forårsage sygdom.
English: Versican Plus L4 is a veterinary vaccine that contains inactivated (killed) strains of Leptospira bacteria (Icterohaemorrhagiae, Canicola, Bratislava and Grippotyphosa).
Danish: Versican Plus L4 er en veterinær vaccine, der indeholder inaktiverede (dræbte) stammer af Leptospirabakterier (Icterohaemorrhagiae, Canicola, Bratislava og Grippotyphosa).
English: Versican Plus L4 is a vaccine.
Danish: Versican Plus L4 er en vaccine.
English: For revaccination a single dose of Versican Plus L4 is required annually.
Danish: Der kræves årlig revaccination med en enkelt dosis af Versican Plus L4.
English: When Versican Plus L4 is given to dogs the animals' immune system recognises the bacteria as ‘foreign' and makes antibodies against them.
Danish: Når Versican Plus L4 gives til hunde, registrerer dyrenes immunsystem bakterierne som “fremmede” og reagerer ved at
English: Versican Plus L4 is used to protect dogs against leptospirosis, a bacterial disease that may be transmitted via infected urine and result in bleeding, hepatitis (inflammation of the liver) and jaundice or nephritis (kidney inflammation).
Danish: Versican Plus L4 anvendes til beskyttelse af hunde mod leptospirose, en bakteriesygdom, der overføres gennem inficeret urin og medfører blødning, leverbetændelse (hepatitis) og gulsot eller nyrebetændelse (nefritis).
English: Other information about Versican Plus L4:
Danish: Andre oplysninger om Versican Plus L4:
English: Versican Plus L4 contains an adjuvant (aluminium hydroxide) to enhance the immune response.
Danish: Versican Plus L4 indeholder aluminiumhydroxid, der er et adjuvans, dvs. det forstærker immunreaktionen.
English: The field study showed that after vaccination with Versican Plus L4 the percentage of dogs with protective levels of antibodies for leptospira ranged from 59 to 96%.
Danish: Feltundersøgelsen viste, at mellem 59 og 96 % af hundene opnåede et beskyttende indhold af antistoffer mod Leptospira efter vaccination med Versican Plus L4.
English: Versican Plus L4 is available as a suspension for injection.
Danish: Versican Plus L4 leveres som injektionsvæske, suspension.
English: What is the risk associated with Versican Plus L4?
Danish: Hvilken risiko er der forbundet med Versican Plus L4?
English: Why has Versican Plus L4 been approved?
Danish: Hvorfor blev Versican Plus L4 godkendt?
English: How has Versican Plus L4 been studied?
Danish: Hvordan blev Versican Plus L4 undersøgt?
English: What is Versican Plus L4?
Danish: Hvad er Versican Plus L4?
English: What benefit has Versican Plus L4 shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Versican Plus L4?
English: What is Versican Plus L4 used for?
Danish: Hvad anvendes Versican Plus L4 til?
English: How does Versican Plus L4 work?
Danish: Hvordan virker Versican Plus L4?
English: ≥ 40 to < 50
Danish: ≥ 40 til < 50
English: Date of first authorisation: 20 June 2019
Danish: Dato for første markedsføringstilladelse: 20. juni 2019
English: Results are shown in Table 2.
Danish: Resultaterne vises i tabel 2.
English: • Your doctor or pharmacist will tell you how many tablets to take and when to take them.
Danish: • Lægen eller apotekspersonalet vil fortælle dig, hvor mange tabletter du skal tage, og hvornår du skal tage dem.
English: The next dose should be taken at the usual time the next day.
Danish: Den næste dosis skal tages på det sædvanlige tidspunkt næste dag.
English: System organ class (MedDRA terminology*)
Danish: Systemorganklasse (MedDRA-terminologi*)
English: No dosage adjustment is expected for these patients.
Danish: Der forventes ikke dosisjustering for disse patienter.
English: The safety and effectiveness of this medicine in this age group is not known.
Danish: Dette lægemiddels sikkerhed og virkning hos personer i denne aldersgruppe kendes ikke.
English: Adverse reactions are classified by Preferred Term and System Organ Class, and by frequency.
Danish: Bivirkningerne er klasificeret efter foretrukken term og systemorganklasse samt hyppighed.
English: - you are very overweight - you smoke - you have advanced chronic liver disease.
Danish: - du er meget overvægtig - du ryger - du har fremskreden, kronisk leversygdom.
English: This medicine can pass into breast milk.
Danish: Dette lægemiddel kan passere over i modermælken.
English: b Cochran-Mantel-Haenszel Test. c Wilcoxon Rank Sum Test.
Danish: b Cochran-Mantel-Haenszel-test. c Wilcoxon-rangsumstest.
English: Effect of transporting proteins
Danish: Virkning af transportproteiner
English: Do not give Doptelet to people less than 18 years old.
Danish: Doptelet må ikke gives til personer under 18 år.
English: 5 days
Danish: 5 dage
English: This adverse reaction was assessed as non-serious.
Danish: Denne bivirkning blev vurderet at være ikke alvorlig.
English: Doptelet works by helping to increase the number of platelets in the blood.
Danish: Doptelet virker ved at hjælpe med at øge antallet af blodplader i blodet.
English: A risk to the breast-feeding child cannot be excluded.
Danish: En risiko for det ammede barn kan ikke udelukkes.
English: 60 mg (3 tablets) every day for 5 days in a row.
Danish: 60 mg (3 tabletter) hver dag i 5 dage i træk.
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).
Danish: Hyppighederne 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) og meget sjælden (< 1/10.000).
English: • Talk to a doctor or pharmacist straight away.
Danish: • Tal med en læge eller apotekspersonalet med det samme.
English: Excretion in Milk
Danish: Udskillelse i mælk
English: Racial or Ethnic Groups
Danish: Race eller etnisk oprindelse
English: Platelets are blood cells that help the blood to clot and so reduce or prevent bleeding.
Danish: Blodplader er blodlegemer, som hjælper blodet med at størkne og dermed mindsker eller forebygger blødning.
English: Doptelet contains lactose (a type of sugar).
Danish: Doptelet indeholder lactose (en type sukker).
English: There are no data on the presence of avatrombopag in human milk, the effects on the breastfed child, or the effects on milk production.
Danish: Der foreligger ingen data om tilstedeværelsen af avatrombopag i human mælk, virkningerne på det ammede barn eller virkningerne på mælkeproduktionen.
English: Duration of treatment Due to limited information, avatrombopag should not be taken for more than 5 days.
Danish: Behandlingsvarighed Da der foreligger begrænsede oplysninger, bør avatrombopag ikke tages i mere end 5 dage.
English: If a dose is missed, it should be taken as soon as it is remembered.
Danish: Hvis en dosis glemmes, skal den tages, så snart det opdages.
English: Co-administration with interferon preparations
Danish: Samtidig administration med interferonpræparater
English: Take Doptelet for as long as your doctor tells you.
Danish: Du skal tage Doptelet så længe, som din læge har fortalt dig.
English: In vitro studies suggest that avatrombopag is highly bound to human plasma proteins (> 96%).
Danish: In vitro-studier tyder på, at avatrombopag er stærkt bundet til humane plasmaproteiner (> 96 %).
English: • Start taking Doptelet 10 to 13 days before your planned medical procedure.
Danish: • Begynd at tage Doptelet 10 til 13 dage før dit planlagte medicinske indgreb.
English: • Take your missed dose as soon as you remember, then take your next dose at the usual time.
Danish: • Tag den glemte dosis, så snart du kommer i tanke om det, og tag derefter den næste dosis på det sædvanlige tidspunkt.
English: * at steady state, except for cyclosporine which was administered as a single dose
Danish: Verapamil * ved steady state, undtagen ciclosporin, som blev administreret som en enkelt dosis
English: There are no or limited amount of data from the use of avatrombopag in pregnant women.
Danish: Der er ingen eller begrænsede data fra anvendelse af avatrombopag til gravide kvinder.
English: Of the 88% of drug-related material in the faeces, 77% was identified as parent (34%) and the 4-hydroxy metabolite (44%).
Danish: Af de 88 % af lægemiddelrelateret materiale i fæces blev 77 % identificeret som moderstof (34 %) og 4-hydroxymetabolit (44 %).
English: Category
Danish: Kategori
English: The usual recommended dose is either 40 mg (2 tablets) or
Danish: Den sædvanlige anbefalede dosis er enten 40 mg (2 tabletter) eller
English: A total of 24.8% of patients were ≥ 65 years of age, 4.6% ≥ 75 years of age, and only 1 (0.2%) ≥ 85 years of age.
Danish: I alt 24,8 % af patienterne var ≥ 65 år, 4,6 % var ≥ 75 år, og kun 1 (0,2 %) var ≥ 85 år.
English: - you are allergic to avatrombopag or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for avatrombopag eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).