natgillin/translations-raw huggingface dataset:
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
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
Behandling mod øremider (hund)
Treatment of ear mites (dogs)
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
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
Krav til lægemiddelovervågning:
Other precautions:
1 pipette Evicto 45 mg til kat 2,6 - 7,5 kg
≤ 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
Behandling mod spolorm (kat og hund)
Treatment of roundworm infections (cats and dogs)
For at forebygge mod lopper gives lægemidlet en gang om måneden i hele loppesæsonen.
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.
EMA afslutter gennemgang efter uoverensstemmelse blandt EUmedlemsstaterne
EMA completes review following disagreement among EU Member States
Hvad er Syner-Kinase?
What is Syner-Kinase?
Hvorfor blev Syner-Kinase undersøgt?
Why was Syner-Kinase reviewed?
Europa-Kommissionen vedtog en afgørelse med gyldighed i hele EU den 16. maj 2019.
A European Commission decision valid throughout the EU was issued on 16/05/2019.
Gennemgangen af Syner-Kinase blev indledt den 26. juli 2018 på foranledning af Storbritannien, jf. artikel 29, stk. 4, i direktiv 2001/83/EF.
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.
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.
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.
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).
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').
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.
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.
EMA anbefaler godkendelse af Syner-Kinase (urokinase) i EU
EMA recommends authorisation of Syner-Kinase (urokinase) in the EU
Syner-Kinase indeholder det aktive stof urokinase, som er et naturligt enzym, der er med til at opløse blodpropper i kroppen.
Syner-Kinase contains the active substance urokinase, a natural enzyme that helps to dissolve blood clots in the body.
Agenturet vurderede også, at dataene fra virksomheden viser, at rensningsprocessen er velegnet til fjernelse af mulige virus- og prion-urenheder.
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.
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.
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).
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.
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
Man gav også udtryk for betænkelighed ved fremstillings- og rensningsprocessen for det aktive stof urokinase, der udvindes af menneskeurin.
Concerns were also raised regarding the manufacturing and purification processes for the active substance urokinase, which is extracted from human urine.
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.
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.
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.
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.
EMA anbefaler godkendelse af Syner-Kinase (urokinase) i EU EMA/446083/2019
EMA recommends authorisation of Syner-Kinase (urokinase) in the EU EMA/299749/2019
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
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.
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.
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.
London, den 18. februar 2009 Dok.
London, 18 February 2009 Doc.
Hvad er Diovan?
What is Diovan?
ref. EMEA/150561/2009 EMEA/H/A-30/998
Ref. EMEA/CHMP/137577/2009 EMEA/H/A-30/998
Offentliggøres med den komplette dokumentation efter Kommissionens afgørelse: Europa-Kommissionen traf en afgørelse den 16. februar 2009.
For publication with complete documentation after commission decision: The European Commission issued a decision on 16 February 2009.
Styrken 320 mg var ikke tilgængelig på alle markeder.
The 320 mg strength was not available in all markets.
Hvorfor blev Diovan vurderet?
Why was Diovan reviewed?
Artikel 30 i direktiv 2001/83/EF, med senere ændringer; indbringelse på baggrund af divergerende nationale beslutninger i medlemsstaterne
Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Liv Mathison (Norge)
Dr Liv Mathison (Norway)
Det markedsføres af virksomheden Novartis.
The company that markets it is Novartis.
CHMP opdaterede også andre dele af produktinformationen i overensstemmelse med de nye tilgængelige data.
The CHMP also updated other parts of the products information to put it in line with the new data available.
Diovan er godkendt i EU efter nationale procedurer.
Diovan is authorised in the European Union (EU) via national procedures.
Alle styrker kan anvendes til disse sygdomme, bortset fra den laveste styrke (40 mg), som ikke kan anvendes til behandling af hypertension.
All strengths can be used in these diseases, except the lowest (40 mg) strength, which cannot be used to treat hypertension.
Evaluering af patienter med hjertesvigt bør altid inkludere vurdering af nyrefunktionen."
Evaluation of patients with heart failure should always include assessment of renal function.”
Diovan findes muligvis også i EU og EØS under følgende andre handelsbetegnelser: Angiosan, Cordinate, Dalzad, Diovane, Kalpress, Miten, Novacard, Provas, Rixil, Tareg og Varexan.
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.
CHMP drøftede tre områder, hvor der var afvigelser:
The CHMP discussed three areas where there was a divergence:
Spørgsmål og svar vedrørende indbringelsesproceduren for Diovan filmovertrukne tabletter og hårde kapsler indeholdende valsartan 40, 80, 160 eller 320 mg
Questions and answers on the referral for Diovan film coated tablets and hard capsules containing valsartan 40, 80, 160 or 320 mg
Udvalget fastslog imidlertid, at en sådan kombination fortsat ikke bør anbefales, før der foreligger yderligere dokumentation for et positivt benefit/risk-forhold.
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.
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.
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.
Højeste daglige dosis administreret i kliniske undersøgelser er 320 mg i delte doser.
The maximum daily dose administered in clinical trials is 320 mg in divided doses.
Det Europæiske Lægemiddelagentur (EMEA) har foretaget en vurdering af Diovan (og tilknyttede navne).
The European Medicines Agency (EMEA) has completed a review of Diovan (and associated names).
Det kan anvendes alene eller i kombination med ACEhæmmere.
It can be used on its own and in combination with ACE inhibitors.
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.
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.
Diovan virker ved at blokere virkningen af angiotensin II.
Diovan works by blocking the effect of angiotensin II.
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.
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.
CHMP vurderede behovet for at harmonisere en række forsigtighedsregler vedrørende brugen:
The CHMP considered the need to harmonise a number of precautions for use:
• Samtidig brug af andre lægemidler, der indeholder kalium eller øger kaliumindholdet.
• concomitant use of other medicinal products containing, or raising the level of, potassium.
Det bør overvejes at nedsætte dosis af samtidigt administreret diuretika.
Consideration should be given to reducing the dose of concomitant diuretics.
Valsartan kan administreres med andre hjertesvigtsbehandlinger.
Valsartan may be administered with other heart failure therapies.
CHMP drøftede endvidere indikationerne i behandlingen af hjertesvigt og efter et nyligt myokardieinfarkt (MI).
The CHMP also discussed the indications in the treatment of heart failure and after a recent myocardial infarction (MI).
CHMP godkendte således følgende: "Den anbefalede startdosis for Diovan er 40 mg to gange daglig.
In conclusion, the CHMP endorsed the following text: “The recommended starting dose of Diovan is 40 mg twice daily.
CHMP godkendte anvendelsen af Diovan til "behandling af essentiel hypertension".
The CHMP endorsed the use of Diovan in the “treatment of essential hypertension”.
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.
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.
Dette bevirker en afslapning i blodkarrene, hvorved blodtrykket falder.
As a result, blood vessels relax and blood pressure is lowered.
Dosis af valsartan bør imidlertid ikke overstige 80 mg hos patienter med kolestase, og det bør anvendes med forsigtighed.
However, the dose of valsartan should not exceed 80 mg in patients with cholestasis and should be used with caution.
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.
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.
Diovan tilhører en gruppe lægemidler kaldet angiotensin II-receptorantagonister, som hjælper med at kontrollere højt blodtryk.
Diovan belongs to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure.
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.
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.
Undersøgelsen blev gennemført inden for rammerne af en indbringelsesprocedure i henhold til artikel
The review was carried out under an ‘Article 30' referral1.
• håndtering af dosisforhøjelse
• how to manage dose increases,
• anvendelsen af Diovan med ACE-hæmmere og betablokkere (tredobbelt kombination) ved kronisk hjertesvigt
• the use of Diovan with ACE inhibitors and betablockers (triple combination) in chronic heart failure,
CHMP godkendte følgende: Der kræves ingen dosisjustering for patienter med en kreatininclearance ≥ 10 ml/min.
The CHMP endorsed following text: No dosage adjustment is required for patients with a creatinine clearance >10ml/min.
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).
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).
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.
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.
Angiotensin II er et stof i kroppen, der medfører forsnævring af blodkarrene og således en stigning i blodtrykket.
Angiotensin II is a substance in the body that causes vessels to tighten, thus causing blood pressure to increase.
CHMP godkendte følgende: "Hvis et lægemiddel, der påvirker kaliumindholdet, anses for at være nødvendigt i kombination med valsartan, anbefales monitorering af serum-kalium".
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”.
Til patienter med mildt til moderat nedsat leverfunktion uden kolestase bør dosis af valsartan ikke overstige 80 mg (jf. pkt.
In patients with mild to moderate hepatic impairment without cholestasis the dose of valsartan should not exceed 80 mg (see section 4.4).
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".
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”.
CHMP bemærkede, at der var uenighed om, hvorvidt Diovan skulle kontraindiceres til patienter med nyresvigt.
The CHMP noted that there was a divergence on whether the use of Diovan should be contraindicated in patients with kidney failure.
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.
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.
• dosisanbefalinger til patienter med nedsat nyre- og leverfunktion.
• dosage recommendations in patients with renal and hepatic impairment.
Da Diovan elimineres biliært, fandt CHMP imidlertid også, at der skulle fastsættes en kontraindikation for patienter med alvorlige leversygdomme, og at det "ikke bør gives til patienter med stærkt nedsat leverfunktion, cirrose eller biliær obstruktion".
However, because Diovan is eliminated via the biliary route, the CHMP agreed that it should be contraindicated in patients with severe liver diseases and “should not be administered in patients with severe hepatic impairment, cirrhosis or biliary obstruction”.
Diovan anvendes til behandling af hjertesvigt, når andre typer medicin til behandling af hjertesvigt, såsom ACE-hæmmere (Angiotensin Converting Enzyme) eller betablokkere, ikke kan anvendes.
In heart failure, Diovan is used when other types of medicines used in heart failure such as Angiotensin Converting Enzyme (ACE) inhibitors or beta blockers, cannot be used.
Udvalget bemærkede, at anvendelse af Diovan efter MI i nogle medlemsstater var begrænset til patienter, der er intolerante over for ACE-hæmmere.
The Committee noted that some Member States (MSs) had a limitation of the use of Diovan after MI to patients intolerant to ACE inhibitors.
Det er blevet bestemt af koordinationsgruppen for gensidig anerkendelse og decentrale procedurer - human (CMD(h)), at Diovan bør harmoniseres.
Diovan has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Samtidig anvendelse med en ACEhæmmer og en beta-blokker kan dog ikke anbefales (se pkt.
However, the triple combination of an ACE inhibitor, a beta blocker and valsartan is not recommended (see sections 4.4 and 5.1).
Udvalget bemærkede, at der ikke er foretaget undersøgelser af valsartan hos patienter med svær nyresvigt, men det identificerede ingen potentielle sikkerhedsproblemer, idet valsartan primært elimineres via fordøjelsesvejen (biliært) og ikke via nyrerne.
The Committee noted that there has been no study of valsartan in patients with severe kidney failure, but they did not identify any possible safety issue has he primary route of elimination of valsartan is via the digestive (biliary), not renal route The CHMP therefore recommended that the contraindication be removed.
Dato for virksomhedens svar:
Company responses provided on: 20 October 2008 Opinion date:
Udvalget erklærede sig enigt i, at ingen dosisjustering i starten af behandlingen er nødvendig hos patienter med mildt til moderat nedsat leverfunktion.
• patients with liver impairment or cholestasis (problems with the elimination of bile).The Committee agreed that no initial dose adjustment is needed in patients with mild to moderate impairment of liver function.
Andre oplysninger om Libertek
Other information about Libertek
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Libertek den 28. februar 2011.
The European Commission granted a marketing authorisation valid throughout the European Union for Libertek on 28 February 2011.
Det kan være nødvendigt at tage Libertek i flere uger, før det begynder at virke.
Patients may need to take Libertek for several weeks before it starts to have an effect.
Den anbefalede dosis Libertek er én tablet én gang dagligt.
The recommended dose of Libertek is one tablet once a day.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Libertek.
This is a summary of the European public assessment report (EPAR) for Libertek.
Der er udarbejdet en risikostyringsplan for at sikre, at Libertek anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Libertek is used as safely as possible.