FrancophonIA/ELRC3.0 huggingface dataset:
English: When replacing another heartworm preventive product in a heartworm disease prevention programme, the first dose of the veterinary medicinal product must be given within a month of the last dose of the former medication.
Danish: Hvis lægemidlet skal erstatte en behandling med et andet præparat, skal første dosis appliceres senest en måned efter den sidste behandling med det tidligere anvendte præparat.
English: Prevention of heartworm disease (cats and dogs)
Danish: Forebyggelse mod hjerteorm (kat og hund)
English: For the prevention of flea infestations, the veterinary medicinal product should be administered to the animal at monthly intervals throughout the flea season, starting one month before fleas become active.
Danish: For at forebygge angreb med lopper, skal behandling af dyret med veterinærlægemidlet foretages en gang om måneden i hele loppesæsonen.
English: Marketing authorisation holder and manufacturer responsible for batch release: VIRBAC
Danish: Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse:
English: AUTHORISATION
Danish: Præparat
English: This stops flea reproduction and may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Danish: Dette stopper udvikling af nye lopper og støtter kontrollen med loppeangreb i dyrets omgivelser.
English: Treatment of biting lice (cats and dogs)
Danish: Behandling mod bidende lus (kat og hund)
English: This is as a result of the adulticidal, larvicidal and ovicidal properties of the product.
Danish: Dette er et resultat af lægemidlets dræbende virkning på voksne lopper, larver og æg.
English: Treatment of hookworm infections (cats)
Danish: Behandling mod øremider (kat)
English: Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will also aid in the prevention of flea infestations in the litter up to seven weeks of age.
Danish: Månedlige behandlinger af drægtige og diegivende dyr vil formindske antallet af lopper og dermed hjælpe med til at forebygge lopper hos kuldet op til syv ugers alderen.
English: 1 pipette of Evicto 15 mg for cats and dogs ≤2.5 kg 2.6-5.0 1 pipette of Evicto 30 mg for dogs 2.6-5.0 kg
Danish: 1 pipette Evicto 30 mg til hund 2,6 - 5,0 kg
English: EU/2/19/242/013 EU/2/19/242/014 EU/2/19/242/015
Danish: EU/2/19/242/014 EU/2/19/242/015
English: EVICTO 15 mg spot on solution for cats and dogs ≤ 2.5 kg EVICTO 30 mg spot on solution for dogs 2.6 - 5.0 kg EVICTO 45 mg spot on solution for cats 2.6 - 7.5 kg EVICTO 60 mg spot on solution for cats 7.6 - 10.0 kg EVICTO 60 mg spot on solution for dogs 5.1 - 10.0 kg EVICTO 120 mg spot on solution for dogs 10.1 - 20.0 kg EVICTO 240 mg spot on solution for dogs 20.1 - 40.0 kg EVICTO 360 mg spot on solution for dogs 40.1 - 60.0 kg
Danish: Evicto 15 mg spot-on, opløsning til kat og hund ≤ 2,5 kg Evicto 30 mg spot-on, opløsning til hund 2,6 - 5,0 kg Evicto 45 mg spot-on, opløsning til kat 2,6 - 7,5 kg Evicto 60 mg spot-on, opløsning til kat 7,6 - 10,0 kg Evicto 60 mg spot-on, opløsning til hund 5,1 - 10,0 kg Evicto 120 mg spot-on, opløsning til hund 10,1 - 20,0 kg Evicto 240 mg spot-on, opløsning til hund 20,1 - 40,0 kg Evicto 360 mg spot-on, opløsning til hund 40,1 - 60,0 kg selamectinum
English: Treatment of ear mites (dogs)
Danish: Behandling mod øremider (hund)
English: Evicto 120 mg spot-on solution for dogs 10.1-20.0 kg Evicto 240 mg spot-on solution for dogs 20.1-40.0 kg Evicto 360 mg spot-on solution for dogs 40.1-60.0 kg selamectin
Danish: Evicto 30 mg spot-on, opløsning til hund 2,6 - 5,0 kg Evicto 60 mg spot-on, opløsning til hund 5,1 - 10,0 kg Evicto 120 mg spot-on, opløsning til hund 10,1 - 20,0 kg Evicto 240 mg spot-on, opløsning til hund 20,1 - 40,0 kg Evicto 360 mg spot-on, opløsning til hund 40,1 - 60,0 kg selamectinum
English: Other precautions:
Danish: Krav til lægemiddelovervågning:
English: ≤ 2.5 1 pipette of Evicto 15 mg for cats and dogs ≤2.5 kg 2.6-7.5 1 pipette of Evicto 45 mg for cats 2.6-7.5 kg
Danish: 1 pipette Evicto 45 mg til kat 2,6 - 7,5 kg
English: Treatment of roundworm infections (cats and dogs)
Danish: Behandling mod spolorm (kat og hund)
English: For the prevention of flea infestations, the veterinary medicinal product should be administered at monthly intervals throughout the flea season, starting one month before fleas become active.
Danish: For at forebygge mod lopper gives lægemidlet en gang om måneden i hele loppesæsonen.
English: EMA completes review following disagreement among EU Member States
Danish: EMA afslutter gennemgang efter uoverensstemmelse blandt EUmedlemsstaterne
English: What is Syner-Kinase?
Danish: Hvad er Syner-Kinase?
English: Why was Syner-Kinase reviewed?
Danish: Hvorfor blev Syner-Kinase undersøgt?
English: A European Commission decision valid throughout the EU was issued on 16/05/2019.
Danish: Europa-Kommissionen vedtog en afgørelse med gyldighed i hele EU den 16. maj 2019.
English: The review of Syner-Kinase was initiated on 26 July 2018 at the request of the United Kingdom, under Article 29(4) of Directive 2001/83/EC.
Danish: Gennemgangen af Syner-Kinase blev indledt den 26. juli 2018 på foranledning af Storbritannien, jf. artikel 29, stk. 4, i direktiv 2001/83/EF.
English: On 28 February 2019, the European Medicines Agency completed a review of Syner-Kinase and associated names following a disagreement among EU Member States regarding its authorisation.
Danish: Den 28. februar 2019 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Syner-Kinase og relaterede navne efter en uoverensstemmelse blandt EU-medlemsstaterne om dets godkendelse.
English: The marketing authorisation holder, Syner-Medica Ltd, requested that the marketing authorisation for Syner-Kinase granted in the UK on 29 September 2006 be recognised in France, Germany, the Netherlands and Spain (the ‘concerned Member States').
Danish: Indehaveren af markedsføringstilladelsen, Syner-Medica Ltd, anmodede om, at den markedsføringstilladelse for Syner-Kinase, der blev udstedt i Storbritannien den 29. september 2006, anerkendes i Frankrig, Holland, Spanien og Tyskland (de berørte medlemsstater).
English: Syner-Kinase is a medicine used to dissolve blood clots in the lungs, in deep veins, in arteries in the arms, hands, legs and feet, or in catheters or cannulae (surgical tubes) placed in a vein.
Danish: Syner-Kinase er et lægemiddel, der anvendes til lyse (opløsning) af blodpropper i lungerne, dybe vener, arterier i arme, hænder, ben og fødder, eller i katetre eller kanyler (kirurgiske slanger), der er anbragt i en vene.
English: EMA recommends authorisation of Syner-Kinase (urokinase) in the EU
Danish: EMA anbefaler godkendelse af Syner-Kinase (urokinase) i EU
English: Syner-Kinase contains the active substance urokinase, a natural enzyme that helps to dissolve blood clots in the body.
Danish: Syner-Kinase indeholder det aktive stof urokinase, som er et naturligt enzym, der er med til at opløse blodpropper i kroppen.
English: The Agency also considered that the data provided by the company show that the purification process is suitable for the removal of possible viral and prion impurities.
Danish: Agenturet vurderede også, at dataene fra virksomheden viser, at rensningsprocessen er velegnet til fjernelse af mulige virus- og prion-urenheder.
English: demonstrated that the production of the semi-purified urokinase (an intermediate step in the production of the active substance) is adequately controlled, and that this intermediate is manufactured at a site that complies with the principles and guidelines of Good Manufacturing Practice (GMP).
Danish: Endelig påviste virksomheden, at fremstillingen af det delvist rensede urokinase (et mellemtrin i fremstillingen af det aktive stof) er tilstrækkeligt kontrolleret, og at dette mellemprodukt fremstilles på et sted, der opfylder principperne og retningslinjerne for god fremstillingspraksis.
English: However, the Member States were not able to reach an agreement and the UK medicines agency referred the matter to EMA for arbitration on 5 July
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den britiske lægemiddelstyrelse indbragte den 5. juli 2018 sagen for EMA med henblik på voldgift.
English: Concerns were also raised regarding the manufacturing and purification processes for the active substance urokinase, which is extracted from human urine.
Danish: Man gav også udtryk for betænkelighed ved fremstillings- og rensningsprocessen for det aktive stof urokinase, der udvindes af menneskeurin.
English: The grounds for the referral were concerns that the data provided by the company, which included published data on other urokinase-containing medicines, were not sufficient to demonstrate that the benefits of Syner-Kinase outweigh its risks.
Danish: Begrundelsen for indbringelsen var en bekymring over, at de data, som virksomheden havde fremlagt, herunder offentliggjorte data om andre urokinase-holdige lægemidler, ikke var tilstrækkelige til at påvise, at fordelene ved Syner-Kinase opvejer risiciene.
English: The Agency concluded that the benefits of Syner-Kinase outweigh its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the EU where the company has applied for a marketing authorisation.
Danish: Agenturet konkluderede, at fordelene ved Syner-Kinase opvejer risiciene, og at den markedsføringstilladelse, der er udstedt i Storbritannien, kan anerkendes i de andre EUmedlemsstater, hvor virksomheden har ansøgt om en markedsføringstilladelse.
English: EMA recommends authorisation of Syner-Kinase (urokinase) in the EU EMA/299749/2019
Danish: EMA anbefaler godkendelse af Syner-Kinase (urokinase) i EU EMA/446083/2019
English: Having reviewed the available data, EMA considered that Syner-Kinase is comparable to the urokinase products mentioned in the published literature, and that the data are adequate to support its proposed use.
Danish: Efter at have gennemgået de tilgængelige data konkluderede EMA, at Syner-Kinase er sammenligneligt med de urokinase-lægemidler, der er nævnt i den publicerede litteratur, og at dataene er tilstrækkelige
English: Therefore, based on the evaluation of the available data, the Agency concluded that the benefits of Syner-Kinase outweigh its risks, and that the marketing authorisation for Syner-Kinase should be granted in all concerned Member States.
Danish: Ud fra de tilgængelige data vurderede agenturet således, at fordelene ved Syner-Kinase opvejer risiciene, og anbefalede derfor udstedelse af markedsføringstilladelse for Syner-Kinase i alle de berørte medlemsstater.
English: London, 18 February 2009 Doc.
Danish: London, den 18. februar 2009 Dok.
English: What is Diovan?
Danish: Hvad er Diovan?
English: Ref. EMEA/CHMP/137577/2009 EMEA/H/A-30/998
Danish: ref. EMEA/150561/2009 EMEA/H/A-30/998
English: For publication with complete documentation after commission decision: The European Commission issued a decision on 16 February 2009.
Danish: Offentliggøres med den komplette dokumentation efter Kommissionens afgørelse: Europa-Kommissionen traf en afgørelse den 16. februar 2009.
English: The 320 mg strength was not available in all markets.
Danish: Styrken 320 mg var ikke tilgængelig på alle markeder.
English: Why was Diovan reviewed?
Danish: Hvorfor blev Diovan vurderet?
English: Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Danish: Artikel 30 i direktiv 2001/83/EF, med senere ændringer; indbringelse på baggrund af divergerende nationale beslutninger i medlemsstaterne
English: Dr Liv Mathison (Norway)
Danish: Liv Mathison (Norge)
English: The company that markets it is Novartis.
Danish: Det markedsføres af virksomheden Novartis.
English: The CHMP also updated other parts of the products information to put it in line with the new data available.
Danish: CHMP opdaterede også andre dele af produktinformationen i overensstemmelse med de nye tilgængelige data.
English: Diovan is authorised in the European Union (EU) via national procedures.
Danish: Diovan er godkendt i EU efter nationale procedurer.
English: All strengths can be used in these diseases, except the lowest (40 mg) strength, which cannot be used to treat hypertension.
Danish: Alle styrker kan anvendes til disse sygdomme, bortset fra den laveste styrke (40 mg), som ikke kan anvendes til behandling af hypertension.
English: Evaluation of patients with heart failure should always include assessment of renal function.”
Danish: Evaluering af patienter med hjertesvigt bør altid inkludere vurdering af nyrefunktionen."
English: Diovan can also be available in the EU and the EEA under other trade names: Angiosan, Cordinate, Dalzad, Diovane, Kalpress, Miten, Novacard, Provas, Rixil, Tareg, and Varexan.
Danish: Diovan findes muligvis også i EU og EØS under følgende andre handelsbetegnelser: Angiosan, Cordinate, Dalzad, Diovane, Kalpress, Miten, Novacard, Provas, Rixil, Tareg og Varexan.
English: The CHMP discussed three areas where there was a divergence:
Danish: CHMP drøftede tre områder, hvor der var afvigelser:
English: Questions and answers on the referral for Diovan film coated tablets and hard capsules containing valsartan 40, 80, 160 or 320 mg
Danish: Spørgsmål og svar vedrørende indbringelsesproceduren for Diovan filmovertrukne tabletter og hårde kapsler indeholdende valsartan 40, 80, 160 eller 320 mg
English: However the Committee agreed that such a combination should still not be recommended until there is more evidence to support its positive benefit-risk balance.
Danish: Udvalget fastslog imidlertid, at en sådan kombination fortsat ikke bør anbefales, før der foreligger yderligere dokumentation for et positivt benefit/risk-forhold.
English: The Committee also concluded that the 320 mg dose provides a modest, but statistically significant additional reduction in blood pressure compared to 160 mg and a similarly modest increase in the rate of blood pressure control.
Danish: Udvalget konkluderede endvidere, at en dosis på 320 mg giver en beskeden, men statistisk signifikant supplerende nedsættelse af blodtrykket sammenlignet med en dosis på 160 mg og en tilsvarende moderat forøgelse af blodtrykskontrollen.
English: The maximum daily dose administered in clinical trials is 320 mg in divided doses.
Danish: Højeste daglige dosis administreret i kliniske undersøgelser er 320 mg i delte doser.
English: The European Medicines Agency (EMEA) has completed a review of Diovan (and associated names).
Danish: Det Europæiske Lægemiddelagentur (EMEA) har foretaget en vurdering af Diovan (og tilknyttede navne).
English: It can be used on its own and in combination with ACE inhibitors.
Danish: Det kan anvendes alene eller i kombination med ACEhæmmere.
English: On 30 May 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 Diovan in the EU and the EEA.
Danish: Den 30. maj 2008 henviste Europa-Kommissionen sagen til Udvalget for Humanmedicinske Lægemidler med henblik på harmonisering af markedsføringstilladelserne for Diovan i EU og EØS.
English: Diovan works by blocking the effect of angiotensin II.
Danish: Diovan virker ved at blokere virkningen af angiotensin II.
English: Uptitration to 80 mg and 160 mg twice daily should be done at intervals of at least two weeks to the highest dose, as tolerated by the patient.
Danish: Optitrering til 80 mg og 160 mg to gange daglig skal foretages med intervaller på mindst to uger til den højeste dosis, som tolereres af patienten.
English: The CHMP considered the need to harmonise a number of precautions for use:
Danish: CHMP vurderede behovet for at harmonisere en række forsigtighedsregler vedrørende brugen:
English: • concomitant use of other medicinal products containing, or raising the level of, potassium.
Danish: • Samtidig brug af andre lægemidler, der indeholder kalium eller øger kaliumindholdet.
English: Consideration should be given to reducing the dose of concomitant diuretics.
Danish: Det bør overvejes at nedsætte dosis af samtidigt administreret diuretika.
English: Valsartan may be administered with other heart failure therapies.
Danish: Valsartan kan administreres med andre hjertesvigtsbehandlinger.
English: The CHMP also discussed the indications in the treatment of heart failure and after a recent myocardial infarction (MI).
Danish: CHMP drøftede endvidere indikationerne i behandlingen af hjertesvigt og efter et nyligt myokardieinfarkt (MI).
English: In conclusion, the CHMP endorsed the following text: “The recommended starting dose of Diovan is 40 mg twice daily.
Danish: CHMP godkendte således følgende: "Den anbefalede startdosis for Diovan er 40 mg to gange daglig.
English: The CHMP endorsed the use of Diovan in the “treatment of essential hypertension”.
Danish: CHMP godkendte anvendelsen af Diovan til "behandling af essentiel hypertension".
English: This has led to divergences across member states on the way the medicine can be used, as seen in the differences observed in the Summaries of Product Characteristics (SPCs), labelling and package leaflets in the countries where the product is marketed.
Danish: Dette har medført afvigelser i lægemidlets anvendelsesmåde i medlemsstaterne, som det fremgår af forskelle i produktresuméer, etikettering og indlægssedler i de lande, hvor lægemidlet markedsføres.
English: As a result, blood vessels relax and blood pressure is lowered.
Danish: Dette bevirker en afslapning i blodkarrene, hvorved blodtrykket falder.
English: However, the dose of valsartan should not exceed 80 mg in patients with cholestasis and should be used with caution.
Danish: Dosis af valsartan bør imidlertid ikke overstige 80 mg hos patienter med kolestase, og det bør anvendes med forsigtighed.
English: Having assessed the data available, the CHMP agreed that valsartan 80 mg can be used as a starting dose in patients with reduced kidney function.
Danish: Efter at have vurderet de tilgængelige data erklærede CHMP sig enigt i, at valsartan 80 mg kan anvendes som startdosis til patienter med nedsat nyrefunktion.
English: Diovan belongs to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure.
Danish: Diovan tilhører en gruppe lægemidler kaldet angiotensin II-receptorantagonister, som hjælper med at kontrollere højt blodtryk.
English: Diovan can be used to treat patients with hypertension (high blood pressure), patients who just have had a heart attack (between 12 hours and 10 days earlier), or patients with heart failure when they show signs that their heart not working fully, such as shortness of breath, and swelling of the feet and legs due to fluid build-up.
Danish: Diovan kan anvendes til behandling af patienter med hypertension (højt blodtryk), patienter, som for nylig har haft et hjerteanfald (mellem 12 timer og 10 dage forinden), eller patienter med hjertesvigt, når de viser tegn på, at deres hjerte ikke fungerer tilstrækkeligt, såsom kortåndethed og hævelse af fødder og ben som følge af væskeophobning.
English: The review was carried out under an ‘Article 30' referral1.
Danish: Undersøgelsen blev gennemført inden for rammerne af en indbringelsesprocedure i henhold til artikel
English: • how to manage dose increases,
Danish: • håndtering af dosisforhøjelse
English: • the use of Diovan with ACE inhibitors and betablockers (triple combination) in chronic heart failure,
Danish: • anvendelsen af Diovan med ACE-hæmmere og betablokkere (tredobbelt kombination) ved kronisk hjertesvigt
English: The CHMP endorsed following text: No dosage adjustment is required for patients with a creatinine clearance >10ml/min.
Danish: CHMP godkendte følgende: Der kræves ingen dosisjustering for patienter med en kreatininclearance ≥ 10 ml/min.
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 Diovan in the European Union (EU) and the European Economic Area (EEA).
Danish: EMEA's Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at der er behov for at harmonisere ordineringsoplysningerne for Diovan i Den Europæiske Union (EU) og Det Europæiske Økonomiske Samarbejdsområde (EØS).
English: But considering that valsartan given on its own is at least as effective as captopril (an ACE inhibitor) given on its own in the reduction of total mortality after an acute MI, the CHMP endorsed the harmonised indication: Treatment of clinically stable patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours - 10 days) myocardial infarction.
Danish: I betragtning af, at valsartan givet alene er mindst lige så effektiv som captopril (en ACE-hæmmer) givet alene til nedbringelse af dødeligheden efter akut MI, godkendte CHMP dog den harmoniserede indikation: Behandling af klinisk stabile patienter med symptomatisk hjertesvigt eller asymptomatisk systolisk dysfunktion i venstre ventrikel efter et nyligt (12 timer-10 dage) myokardieinfarkt.
English: Angiotensin II is a substance in the body that causes vessels to tighten, thus causing blood pressure to increase.
Danish: Angiotensin II er et stof i kroppen, der medfører forsnævring af blodkarrene og således en stigning i blodtrykket.
English: The CHMP endorsed the following text: “If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, monitoring of potassium plasma levels is advised”.
Danish: CHMP godkendte følgende: "Hvis et lægemiddel, der påvirker kaliumindholdet, anses for at være nødvendigt i kombination med valsartan, anbefales monitorering af serum-kalium".
English: In patients with mild to moderate hepatic impairment without cholestasis the dose of valsartan should not exceed 80 mg (see section 4.4).
Danish: Til patienter med mildt til moderat nedsat leverfunktion uden kolestase bør dosis af valsartan ikke overstige 80 mg (jf. pkt.
English: The CHMP also aligned the contraindication for the use of Diovan during pregnancy or lactation with recent the recommendations of the Pharmacovigilance experts, and therefore recommended that the contraindication in pregnancy be removed and the recommendation for the use during breast feeding be: “Because no information is available regarding the use of valsartan during breastfeeding, Diovan (Valsartan) is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant”.
Danish: CHMP sammenholdt endvidere kontraindikationen for brug af Diovan under graviditet og amning med de nylige henstillinger fra eksperterne i lægemiddelovervågning og anbefalede således at fjerne kontraindikationen for graviditet og at medtage følgende henstilling vedrørende anvendelse under amning: "Da der ikke foreligger nogen oplysninger om brugen af valsartan under amning, frarådes brug af Diovan (valsartan), og alternativ behandling med bedre sikkerhedsprofiler under amning foretrækkes, navnlig ved amning af nyfødte eller for tidligt fødte spædbørn".
English: The CHMP noted that there was a divergence on whether the use of Diovan should be contraindicated in patients with kidney failure.
Danish: CHMP bemærkede, at der var uenighed om, hvorvidt Diovan skulle kontraindiceres til patienter med nyresvigt.
English: Looking at the results of studies where triple combination treatment was used (such as a study called VALIANT), the CHMP noted that as there was no increased mortality in patients receiving all three medicines, and therefore there should be no concerns regarding the triple combination.
Danish: CHMP vurderede resultaterne af undersøgelser, hvor der var anvendt tredobbelt behandling (såsom VALIANT-undersøgelsen), og bemærkede, at der ikke var tendens til øget dødelighed hos patienter, der modtog alle tre lægemidler, og at den tredobbelte behandling derfor ikke gav anledning til betænkelighed.
English: • dosage recommendations in patients with renal and hepatic impairment.
Danish: • dosisanbefalinger til patienter med nedsat nyre- og leverfunktion.