FrancophonIA/ELRC3.0 huggingface dataset:
English: In particular, the CHMP was of the opinion that the data provided by the company was not robust enough to clearly demonstrate that canakinumab Novartis is effective in all patients who have had a heart attack.
Danish: Nærmere bestemt var CHMP af den opfattelse, at de data, som virksomheden havde fremlagt, ikke var solide nok til klart at påvise, at canakinumab Novartis er effektivt hos alle patienter, der har haft et hjerteanfald.
English: On 4 December 2018, Novartis Europharm Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for canakinumab Novartis, for the prevention of serious events such as stroke, heart attack or death in patients who have had a heart attack.
Danish: Den 4. december 2018 meddelte Novartis Europharm Ltd. officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for canakinumab Novartis til forebyggelse af alvorlige hændelser som f.eks. slagtilfælde, hjerteanfald eller død hos patienter, der tidligere har haft et hjerteanfald.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of canakinumab Novartis did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved canakinumab Novartis ikke opvejede risiciene.
English: Canakinumab Novartis is a medicine that contains the active substance canakinumab.
Danish: Canakinumab Novartis er et lægemiddel, der indeholder det aktive stof canakinumab.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had remaining concerns and was of the provisional opinion that canakinumab Novartis could not have been approved for the prevention of serious heart problems in patients who have already had a heart attack.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP fortsat betænkeligheder og var af den foreløbige opfattelse, at canakinumab Novartis ikke ville kunne være blevet godkendt til forebyggelse af alvorlige hjerteproblemer hos patienter, som tidligere har haft hjerteanfald.
English: Patients were given canakinumab Novartis at different doses (50, 150 or 300 mg) or placebo (a dummy treatment) once every three months for up to six years.
Danish: Patienterne fik canakinumab Novartis i forskellige doser (50, 150 eller 300 mg) eller
English: What was canakinumab Novartis expected to be used for?
Danish: Hvad forventedes canakinumab Novartis anvendt til?
English: commonly used to prevent heart problems, such as statins.
Danish: Patienterne fik også andre lægemidler, der almindeligvis anvendes til forebyggelse af hjerteproblemer som f.eks. statiner.
English: What is canakinumab Novartis?
Danish: Hvad er canakinumab Novartis?
English: How does canakinumab Novartis work?
Danish: Hvordan virker canakinumab Novartis?
English: EMA/215997/2006 EMEA/V/C/000098
Danish: EMEA/215997/2006 EMEA/V/C/000098
English: This summary was last updated in: 04-2013.
Danish: Dette sammendrag blev sidst ajourført den: 04-2013.
English: Other information about Convenia:
Danish: Andre oplysninger om Convenia:
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Convenia on 19 June 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse for Convenia med gyldighed i hele Den Europæiske Union den 19. juni 2006.
English: Depending on the infection concerned, the injection can be repeated if necessary (up to three times).
Danish: Afhængigt af den pågældende infektion kan injektionen om nødvendigt gentages (op til tre gange).
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger på grundlag af CVMPs anbefalinger, kan du læse den faglige drøftelse (der ligeledes er en del af EPAR).
English: Treated animals should not be used for breeding for 12 weeks after the last injection of Convenia.
Danish: Behandlede dyr bør ikke anvendes til avl i 12 uger efter sidste injektion med Convenia.
English: One injection lasts for up to 14 days.
Danish: Én injektion varer i op til 14 dage.
English: No side-effects have been reported with Convenia to date.
Danish: Til dato er der ikke indberettet bivirkninger i forbindelse med Convenia.
English: Swelling of the face, lips or eyes, or any difficulty breathing are more serious symptoms and require urgent medical attention.
Danish: Hævelse af ansigt, læber eller øjne eller åndedrætsbesvær er mere alvorlige symptomer og kræver omgående lægebehandling.
English: Convenia should be handled with care and all the recommended precautions be taken to avoid exposure to the product.
Danish: Convenia bør håndteres med omhu, og der skal tages alle mulige forholdsregler for at undgå eksponering for produktet.
English: The studies measured the rate at which the infections were cured.
Danish: Undersøgelserne målte, hvor hurtigt infektionerne blev kureret.
English: If any symptoms occur after accidental exposure to Convenia, for example a skin rash, then the advice of a doctor should be sought immediately.
Danish: Hvis der opstår symptomer efter utilsigtet eksponering for Convenia, for eksempel udslæt på huden, bør man straks søge råd hos en læge.
English: It would be dangerous to use Convenia in other animals such as guinea pigs and rabbits (it is not licensed for use in these species).
Danish: Det ville være farligt at anvende Convenia hos andre dyr såsom marsvin og kaniner (det er ikke godkendt til anvendelse hos disse arter).
English: It is generally given as a single injection, and the effect of the injection lasts for up to 14 days.
Danish: Det gives normalt som en enkel injektion, og virkningen af injektionen varer i op til 14 dage.
English: Like other antibiotics, cefovecin is not effective against all types of bacteria.
Danish: Som andre antibiotika er cefovecin ikke effektiv mod alle typer bakterier.
English: What is the risk associated with Convenia?
Danish: Hvilken risiko er der forbundet med Convenia?
English: Cephalosporin and penicillin antibiotics can cause allergies in humans, and sometimes these allergies can be very serious.
Danish: Cefalosporin-antibiotika og antibiotika af penicillintypen kan forårsage allergier hos mennesker, og sommetider kan disse allergier være meget alvorlige.
English: Convenia should also not be used in dogs or cats of less than 8 weeks old, or in dogs or cats with severe kidney problems (renal dysfunction).
Danish: Convenia bør heller ikke anvendes hos hunde eller katte under otte uger gamle eller hos hunde eller katte med svære nyreproblemer (nedsat nyrefunktion).
English: All these cephalosporin antibiotics, including cefovecin, kill bacteria by disrupting the building of the bacterial cell walls, so the bacteria die and the infection is cured.
Danish: Alle disse cefalosporin-antibiotika, herunder cefovecin, dræber bakterierne ved at forstyrre opbygningen af bakteriernes cellevægge, således at bakterierne dør, og infektionen kureres.
English: The powder is dissolved in the diluent before use to make up a solution for injection.
Danish: Pulveret opløses i fortyndingsvæsken inden brug for at danne en injektionsopløsning.
English: Cefovecin differs from other similar cephalosporin antibiotics as it stays in the dog's or cat's body for a very long time after it has been injected.
Danish: Cefovecin afviger fra andre lignende cefalosporin-antibiotika, da det forbliver i hunden eller kattens krop i meget lang tid efter, at det er blevet indsprøjtet.
English: Data from laboratory studies with different bacteria showed that cefovecin was effective against the bacteria specified in the product information (SPC and package leaflet).
Danish: Data fra laboratorieforsøg med forskellige bakterier viste, at cefovecin var effektiv mod de bakterier, der er specificeret i produktinformationen (produktresumeet og indlægssedlen).
English: Why has Convenia been approved?
Danish: Hvorfor er Convenia blevet godkendt?
English: As no studies have been made in breeding animals with Convenia and it has an exceptionally long duration in the body, Convenia should not be used in pregnant or lactating dogs or cats.
Danish: Da der ikke har været udført forsøg med Convenia hos dyr, der avles på, og da Convenia forbliver særlig længe i kroppen, bør det ikke anvendes hos drægtige eller diende hunde eller katte.
English: The active substance in Convenia is cefovecin which belongs to a class of antibiotics called third generation cephalosporins.
Danish: Det aktive stof i Convenia er cefovecin, som tilhører en klasse antibiotika, der kaldes 3. generations cefalosporiner.
English: Convenia contains cefovecin, an antibiotic which is given by injection (under the skin).
Danish: Convenia indeholder cefovecin, et antibiotikum, der gives som en injektion (under huden).
English: Convenia is used to treat infections caused by certain specific bacteria (see the SPC for further details).
Danish: Convenia anvendes til behandling af infektioner, forårsaget af visse specifikke bakterier (se produktresumeet for yderligere oplysninger).
English: How has Convenia been studied?
Danish: Hvordan er Convenia blevet undersøgt?
English: What is Convenia used for?
Danish: Hvad anvendes Convenia til?
English: There are two vials in each pack of Convenia, one vial containing a powder, and one vial containing the diluent.
Danish: Hver pakke med Convenia indeholder to hætteglas, hvoraf det ene hætteglas indeholder et pulver, og det andet hætteglas indeholder fortyndingsvæsken.
English: However, it should not be used in dogs or cats which have shown an allergy to any cephalosporin or penicillin-type antibiotics.
Danish: Convenia bør dog ikke anvendes hos hunde eller katte, der har vist sig at være allergiske over for cefalosporin-antibiotika eller antibiotika af penicillintypen.
English: What is Convenia?
Danish: Hvad er Convenia?
English: Convenia is used in cats to treat skin and soft tissue infections, such as wounds and abscesses.
Danish: Convenia anvendes hos katte til behandling af infektioner i hud og blødt væv som for eksempel sår og bylder.
English: In all studies, Convenia was as effective in curing the infection as the comparator antibiotic.
Danish: I alle forsøgene var Convenia lige så effektiv til at kurere infektionen som det antibiotikum, det blev sammenlignet med. Convenia har fordelen ved en lang virkningsvarighed.
English: What benefit has Convenia shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Convenia?
English: It is also used in dogs to treat urinary tract infections caused by certain specific bacteria.
Danish: Det anvendes endvidere hos hunde til behandling af urinvejsinfektioner, forårsaget af visse specifikke bakterier.
English: It is also used in cats to treat urinary tract infections caused by certain specific bacteria.
Danish: Det anvendes endvidere hos katte til behandling af urinvejsinfektioner, forårsaget af visse specifikke bakterier.
English: Convenia has been studied in dogs with skin and soft tissue infections (where it was compared to another antibiotic containing amoxicillin and clavulanic acid) and in dogs with urinary tract infections (where it was compared to another cephalosporin antibiotic, cefalexin).
Danish: Convenia er blevet undersøgt hos hunde med infektioner i hud og blødt væv, (hvor det blev sammenlignet med et andet antibiotikum, der indeholdt amoxicillin og clavulansyre), og hos hunde med urinvejsinfektioner, (hvor det blev sammenlignet med et andet cefalosporin-antibiotikum, cefalexin).
English: Convenia has also been studied in cats with skin and soft tissue infections (where it was compared to another antibiotic containing amoxicillin and clavulanic acid), and in a small study in cats with urinary tract infections, where it was compared with cefalexin.
Danish: Convenia er også blevet undersøgt hos katte med infektioner i hud og blødt væv, (hvor det blev sammenlignet med et andet antibiotikum, der indeholdt amoxicillin og clavulansyre) samt i et mindre forsøg med katte med urinvejsinfektioner, hvor det blev sammenlignet med cefalexin.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Convenia exceed the risks for the treatment of dogs and cats with certain specified skin, soft tissue and urinary tract infections and recommended that Convenia should be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Convenia er større end risiciene til behandling af hunde og katte med visse specificerede infektioner i hud, blødt væv og urinveje.
English: How does Convenia work?
Danish: Hvordan virker Convenia?
English: Convenia is used in dogs to treat skin and soft tissue infections; these are infections on the skin and in the layers just below the skin, such as wounds, abscesses and pyoderma (a skin infection with a rash and pustules).
Danish: Dette er infektioner i huden og i lagene lige under huden som for eksempel sår, bylder og pyoderma (en hudinfektion med udslæt og pustler).
English: Anyone allergic to penicillins or cephalosporins should also avoid contact with litter used by dogs or cats treated with Convenia.
Danish: Convenia bør derfor ikke håndteres af personer, der er overfølsomme (allergiske) over for sådanne antibiotika, eller af personer der er blevet rådet til ikke at arbejde med dem. Alle personer, der er allergiske over for penicilliner eller cefalosporiner, bør ligeledes undgå kontakt med strøelse/kattegrus der er anvendt af hunde eller katte, der er behandlet med Convenia.
English: 1 dose (0.5 ml) contains:
Danish: 1 dosis (0,5 ml) indeholder: Difteri toxoid*
English: 2.5 micrograms conjugated to tetanus toxoid as a carrier adsorbed on aluminium hydroxide hydrated Total: 0.26 milligrams Al3+ ** adsorbed on aluminium phosphate Total: 0.40 milligrams Al *** produced in Saccharomyces cerevisiae cells by recombinant DNA technology
Danish: 5-10 mikrogram adsorberet til aluminiumhydroxidhydrat ** adsorberet til aluminiumfosfat *** fremstillet i Saccharomyces cerevisae celler vha. rekombinant DNA teknologi
English: Diphtheria toxoid*
Danish: Stivkrampe toxoid*
English: Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 2
Danish: Hepatitis B virus overflade antigen rekombinant** (S protein)*** Haemophilus influenzae type b polysaccharid (polyribosylribitolfosfat)
English: Invented nam Strength Pharmaceutical
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej Emballage Indhold
English: Inactivated Bordetella pertussis strain** Hepatitis B virus surface antigen recombinant** (S protein)***
Danish: Inaktiveret stamme af Bordetella pertussis**
English: --1 ≥ 50x106 CD54+ cells/250mL
Danish: --1 ≥ 50x106 CD54+-celler/250 ml
English: MA (EU) Number (Invented) name
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage Indhold (Koncentration)
English: It is not known how common this condition is.
Danish: Det vides ikke, hvor almindelig denne tilstand er.
English: Repeat steps 3 to 7 in the same way until the whole dose has been taken.
Danish: Gentag trin 3 til 7 på samme måde, indtil hele dosen er taget.
English: Stop taking CELSENTRI.
Danish: Stop med at tage Celsentri.
English: This is due to a sudden fall in blood pressure.
Danish: Dette skyldes et pludseligt fald i blodtrykket.
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Danish: Sådanne reaktioner er typisk observeret inden for de første få uger eller måneder efter initiering af CART.
English: To date, no signature mutation(s) have been identified.
Danish: Hidtil er der ikke identificeret nogen signaturmutation(er).
English: The position of these mutations was not consistent between different isolates.
Danish: Positionen af disse mutationer er ikke konsistent mellem forskellige isolater.
English: Age (years) (Range, years)
Danish: Alder (år) (interval, år)
English: CELSENTRI can be taken with or without food.
Danish: Celsentri kan tages med eller uden mad.
English: Risk Management plan (RMP)
Danish: • Risikostyringsplan (RMP)
English: Potential effect on immunity
Danish: Mulig virkning på immunitet
English: The results should therefore be interpreted with caution.
Danish: Resultaterne skal derfor tolkes med forsigtighed.
English: B 1930 Zaventem Belgium
Danish: B 1930 Zaventem Belgien
English: Talk to your doctor about how to avoid infecting other people.
Danish: Tal med lægen om, hvordan du undgår at smitte andre personer.
English: Keep taking CELSENTRI until your doctor tells you to stop.
Danish: Bliv ved med at tage Celsentri, indtil lægen siger, du skal stoppe.
English: Demographic and Baseline Characteristics
Danish: Demografiske og baseline karakteristika
English: These findings are considered of low human relevance.
Danish: Disse fund anses for at have lav relevans for mennesker.
English: Administration of activated charcoal may also be used to aid in removal of unabsorbed active substance.
Danish: Administration af aktivt kul kan også anvendes til at fjerne ikke-absorberet aktivt stof.
English: Number of active ARVs in OBT1:
Danish: Antal aktive ARV i OB1:
English: The remainder was excreted as metabolites.
Danish: Resten blev udskilt som metabolitter.
English: Difference1 (Confidence Interval2)
Danish: Forskel1 (konfidensinterval2)
English: The corresponding paediatric dose can then be obtained from Table 1 below.
Danish: Den tilsvarende pædiatriske dosis kan derefter findes i tabel 1 nedenfor.
English: Recommendations concerning coadministration in adults
Danish: Anbefalinger vedrørende samtidig administration hos voksne
English: Combination with two inducers has not been studied.
Danish: Kombination med to induktorer er ikke undersøgt.
English: Conditions you need to look out for
Danish: Tilstande, du skal være opmærksom på
English: The MOTIVATE studies were extended beyond 96 weeks, with an observational phase extended to 5 years in order to assess the long term safety of maraviroc.
Danish: MOTIVATE-studierne blev forlænget ud over 96 uger, med en observationsfase forlænget til 5 år, for at kunne vurdere den langsigtede sikkerhed af maraviroc.
English: This should be taken into consideration when treating infections such as active tuberculosis and invasive fungal infections.
Danish: Dette skal tages i betragtning, når der behandles infektioner som f.eks. aktiv tuberkulose og invasive svampeinfektioner.
English: Your liver function may need to be closely monitored.
Danish: Det kan være nødvendig at følge din leverfunktion nøje.
English: See the diagram and instructions at the end of this section for how to measure and take (or give) a dose of medicine.
Danish: Se diagrammet og anvisningerne i slutningen af dette punkt for information om, hvordan man afmåler og tager (eller giver) en dosis medicin.
English: Therefore there is a need to start therapy shortly after a tropism test.
Danish: Derfor er det nødvendigt at starte behandling kort tid efter en tropismetest.
English: • telaprevir and boceprevir.
Danish: • telaprevir og boceprevir.
English: This helps your body to increase the CD4 cell count in your blood.
Danish: Dette hjælper din krop til at øge antallet af CD4-celler i dit blod.
English: (See also ‘Liver problems' in section 4).
Danish: (Se også "Leverproblemer" i punkt 4).
English: CELSENTRI should always be taken by mouth.
Danish: Celsentri skal altid tages via munden.
English: Skin and liver reactions can occur as single events, or in combination.
Danish: Hud- og leverreaktioner kan opstå som enkeltstående hændelser eller i kombination.
English: When they start treatment, the immune system becomes stronger, so the body starts to fight infections.
Danish: Når de begynder behandlingen, bliver immunsystemet stærkere, så kroppen begynder at bekæmpe infektioner.
English: Contact your doctor or the nearest hospital immediately.
Danish: Kontakt straks lægen eller nærmeste hospital.
English: The population was 52% female and 69% black, with mean age of 10 years (range: 2 years to 17 years).
Danish: Populationen var 52 % kvinder og 69 % sorte med en gennemsnitsalder på 10 år (interval: 2 år til 17 år).
English: 1Based on GSS.
Danish: 1Baseret på GSS-score.
English: If you have a kidney problem, your doctor may alter your dose.
Danish: Hvis du har nyreproblemer, kan det være, at lægen ændrer din dosis.
English: After first opening: 60 days
Danish: Efter anbrud: 60 dage
English: Date of first authorisation: 18th September 2007 Date of latest renewal: 20 July 2012
Danish: Dato for seneste fornyelse: 20. juli 2012
English: Other metabolites are products of mono-oxidation and are only minor components of plasma radioactivity.
Danish: Andre metabolitter er produkter af mono-oxidation og er kun mindre komponenter med plasmaradioaktivitet.
English: These medicines are all called anti-HIV medicines or antiretrovirals.
Danish: Disse lægemidler kaldes anti-hiv-medicin eller antiretrovirale lægemidler.
English: This polar metabolite has no significant pharmacological activity.
Danish: Denne polære metabolit har ingen betydende farmakologisk aktivitet.
English: The volume of distribution of maraviroc is approximately 194 L.
Danish: Distributionsvolumen af maraviroc er ca. 194 l.
English: CELSENTRI, as part of combination therapy, reduces the amount of virus in your body, and keeps it at a low level.
Danish: Celsentri, som en del af kombinationsbehandling, nedsætter mængden af virus i kroppen, og holder det på et lavt niveau.
English: CD4 cells are a type of white blood cell that are important in helping your body to fight infection.
Danish: CD4-celler er en type hvide blodlegemer, der er vigtige for at hjælpe kroppen med at bekæmpe infektion.
English: Any inflammatory symptoms should be evaluated and treatment initiated when necessary.
Danish: Alle inflammatoriske symptomer bør vurderes og behandling påbegyndes efter behov.
English: If you or your child stop taking CELSENTRI
Danish: Hvis du eller dit barn holder op med at tage Celsentri
English: Component of a multipack, cannot be sold seperately.
Danish: Del af multipakning, kan ikke sælges separat.
English: You need to know about important signs and symptoms to look out for while you're taking CELSENTRI.
Danish: Det er nødvendigt, at du kender vigtige tegn og symptomer, du skal holde øje med, mens du tager Celsentri.
English: Traditional IC50/IC90 fold-change was not a useful parameter to measure phenotypic resistance, as those values were sometimes unchanged despite significantly reduced sensitivity.
Danish: Traditionel IC50/IC90 gange ændring er ikke en nyttig parameter til at måle fænotypisk resistens, da disse værdier nogle gange er uændret til trods for signifikant reduceret følsomhed.
English: Don't drive, cycle, or operate tools or machines unless you are sure you're not affected.
Danish: Du må ikke føre motorkøretøj, cykle eller betjene værktøj eller maskiner, medmindre du er sikker på, at du ikke er påvirket.
English: CELSENTRI can make you dizzy.
Danish: Celsentri kan gøre dig svimmel.
English: If you are pregnant, if you become pregnant, or if you are planning to have a baby: Talk to your doctor about the risks and benefits of taking CELSENTRI.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at få et barn,: Tal med lægen om risici og fordele ved at tage Celsentri.
English: How to measure the dose and take the medicine
Danish: Sådan afmåler du dosis og tager medicinen
English: Rifabutin is considered to be a weaker inducer than rifampicin.
Danish: Rifabutin anses for at være en svagere induktor end rifampicin.
English: Dispose of any unused oral solution 60 days after first opening the bottle.
Danish: Bortskaf ubrugt oral opløsning 60 dage efter, at flasken først blev åbnet.