FrancophonIA/ELRC3.0 huggingface dataset:
English: The current CHMP review was initiated at the request of the German medicines agency to take into account further data and analyses from the BART study and other sources that have become available since 2007.
Danish: Den aktuelle CHMP-gennemgang blev indledt på foranledning af den tyske lægemiddelstyrelse med henblik på at tage hensyn til yderligere data og analyser fra BART-undersøgelsen og andre kilder, der er blevet tilgængelige siden 2007.
English: The European Commission issued a decision for tranexamic acid on 10 October 2012.
Danish: Europa-Kommissionen traf en beslutning om tranexamsyre den 10. oktober 2012.
English: On 14 February 2012, the European Medicines Agency completed a review of the antifibrinolytic medicines aprotinin, aminocaproic acid and tranexamic acid.
Danish: Den 14. februar 2012 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af de antifibrinolytiske lægemidler aprotinin, aminocapronsyre og tranexamsyre.
English: The CHMP set out conditions for the reintroduction of aprotinin medicines onto the market and also made recommendations on the use of aminocaproic acid and tranexamic acid.
Danish: CHMP fastsatte betingelserne for, at lægemidler indeholdende aprotinin kan komme tilbage på markedet, samt anbefalinger for anvendelsen af aminocapronsyre og tranexamsyre.
English: The CHMP revisited its previous recommendation on aprotinin, taking into account the new information from the BART study.
Danish: CHMP gennemgik på ny sin tidligere anbefaling om aprotinin under hensyntagen til de nye oplysninger fra BART-undersøgelsen.
English: Antifibrinolytics work by preventing fibrinolysis, the natural process by which blood clots are broken down.
Danish: Antifibrinolytika virker ved at forhindre fibrinolyse, som er den naturlige proces til nedbrydning af blodpropper.
English: The European Commission issued a decision for aminocaproic acid on 10 October 2012.
Danish: Europa-Kommissionen traf en beslutning om aminocapronsyre den 10. oktober 2012.
English: A registry will be set up in the EU to monitor the use of aprotinin, and the CHMP has approved a risk management plan for aprotinin medicines.
Danish: EU til overvågning af anvendelsen af aprotinin, og CHMP har godkendt en risikostyringsplan for lægemidler indeholdende aprotinin.
English: The amended information for tranexamic acid can be found here.
Danish: Den ændrede produktinformation for tranexamsyre findes her.
English: Furthermore, the CHMP advised that careful consideration be given to benefits and risks of aprotinin, and the availability of alternative treatments.
Danish: CHMP anbefalede desuden nøje afvejning af aprotinins fordele og risici i betragtning af, at andre behandlinger er tilgængelige.
English: At the time of its recommendation, the CHMP had envisaged a further review once final data from the BART study became available.
Danish: På tidspunktet for denne anbefaling havde CHMP påtænkt at foretage en yderligere gennemgang, når de endelige resultater af BART-undersøgelsen forelå.
English: The amended prescribing information on aprotinin medicines for doctors can be found here.
Danish: Den ændrede produktinformation for lægemidler indeholdende aprotinin (beregnet for læger) findes her.
English: The CHMP therefore concluded that the benefits of aprotinin outweigh its risk in appropriately managed patients undergoing isolated heart bypass surgery (not combined with other heart surgery), and recommended that the suspension of aprotinin medicines in the EU be lifted for this revised indication.
Danish: CHMP konkluderede derfor, at fordelene ved aprotinin overstiger dets risiko hos passende behandlede patienter, der får foretaget isoleret bypassoperation på hjertet (dvs. ikke kombineret med andre hjerteoperationer).
English: NO - Norway
Danish: NO - Norge
English: UK - United Kingdom Pharmacia Limited Walton Oaks, Dorking Road, Tadworth
Danish: UK - Storbritannien Pharmacia Limited Walton Oaks, Dorking Road, Tadworth
English: Bioindutria Laboratorio Italiano Medicinali spa Via De Ambrosiis, 2 15067 Novi Ligure Alessandria Italy
Danish: Bioindutria Laboratorio Italiano Medicinali spa Via De Ambrosiis, 2 15067 Novi Ligure Alessandria
English: TRANEXAMICO BIOINDUTRIA L.I.M.
Danish: Acido tranexamico bioindutria L.I.M.
English: CY - Cyprus
Danish: CY - Cypern
English: DK - Denmark
Danish: DK - Danmark
English: ET - Estonia
Danish: ET - Estland
English: List of the invented names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Danish: Fortegnelse over lægemidlernes navne, lægemiddelform(er), styrke(r), indgivelsesvej(e), indehaver(e) af markedsføringstilladelse(r) i medlemsstaterne
English: Tranexamic acid containing medicinal products with Marketing Authorisation in the European Union
Danish: Indeholdende tranexamsyre lægemidler med en markedsføringstilladelse i den Europæiske Union Medlemsstat (EU/EØS)
English: CZ - Czech Republic Sanofi-Aventis, s.r.o., Evropská 846/176a, 160 00
Danish: Sanofi-Aventis, s.r.o., Evropská 846/176a, 160 00 Praha 6, Czech Republic
English: HU - Hungary sanofi-aventis Zrt.
Danish: Sanofi-Aventis Zrt.
English: SE - Sweden
Danish: SE - Sverige
English: FR - France
Danish: FR - Frankrig
English: NL - Netherlands
Danish: NL - Holland
English: PL - Poland
Danish: PL - Polen
English: IE - Ireland
Danish: IE - Irland
English: AT - Austria
Danish: AT - Østrig
English: IS - Iceland
Danish: IS - Island
English: IT - Italy
Danish: IT - Italien
English: A. NIKOLAKOPOULOS A.E. GALATSIOU AVENUE 115, Athens 11146
Danish: EL - Grækenland A. Nikolakopoulos A.E. Galatsiou Avenue 115,
English: ES - Spain
Danish: ES - Spanien
English: Sanofi-Aventis France Boulevard Romain Rolland 113, F-75014 Paris, France solution for infusion intravenous use
Danish: Sanofi-Aventis France Boulevard Romain Rolland 113, F-75014 Paris, France
English: Solution for Injection or infusion intravenous use
Danish: Injektions- eller infusionsvæske, opløsning
English: DE - Germany
Danish: DE - Tyskland
English: 01-207 Warsaw, Poland solution for infusion intravenous use
Danish: 01-207 Warsaw, Poland
English: Praha 6, Czech Republic
Danish: CZ - Tjekkiet
English: BE - Belgium PFIZER S.A.N.V.
Danish: Pfizer S.A.N.V.
English: EL - Greece
Danish: HU - Ungarn
English: This summary was last updated in 09-2017.
Danish: Dette sammendrag blev sidst ajourført i 09-2017.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Invega on 25 June 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Invega den 25. juni 2007.
English: What is Invega and what is it used for?
Danish: Hvad er Invega, og hvad anvendes det til?
English: The full EPAR for Invega can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Invega findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Invega.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Invega.
English: The two studies together involved a total of 614 patients.
Danish: I alt 614 patienter deltog i de to undersøgelser.
English: It is available as prolonged-release tablets (3, 6, 9 and 12 mg).
Danish: Det fås som depottabletter (3, 6, 9 og 12 mg).
English: Invega paliperidone
Danish: Invega paliperidon
English: Schizophrenia
Danish: Skizofreni
English: Patients can take Invega either with food or between meals, but should not switch between taking it with food on one day and between meals on another.
Danish: Patienten kan tage Invega med eller uden mad, men bør ikke skifte mellem at tage lægemidlet med mad én dag og uden mad en anden dag.
English: Other information about Invega
Danish: Andre oplysninger om Invega
English: What measures are being taken to ensure the safe and effective use of Invega?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Invega?
English: It is not intended to provide practical advice on how to use Invega.
Danish: Det er ikke en praktisk vejledning i, hvordan Invega bør anvendes.
English: Similar results were seen in the other two short-term studies, with higher doses of Invega being more effective than lower doses.
Danish: Lignende resultater sås i de to andre korttidsundersøgelser, idet høje doser af Invega var mere effektive end lave doser.
English: Why is Invega approved?
Danish: Hvorfor blev Invega godkendt?
English: Invega can only be obtained with a prescription.
Danish: Invega udleveres kun efter recept.
English: Invega contains the active substance paliperidone.
Danish: Invega indeholder det aktive stof paliperidon.
English: By blocking these receptors, paliperidone helps to normalise the activity of the brain and reduce symptoms.
Danish: Ved at blokere disse receptorer medvirker paliperidon til at normalisere hjernens aktivitet og mindske symptomerne.
English: Side effects in adolescents are similar to those in adults, although some side effects may occur more frequently.
Danish: Bivirkningerne hos unge er de samme som hos voksne, selvom nogle bivirkninger kan optræde hyppigere.
English: What are the risks associated with Invega?
Danish: Hvilke risici er der forbundet med Invega?
English: This is a condition in which the patient has episodes of elevated mood (mania) or low mood (depression) in addition to symptoms of schizophrenia.
Danish: Det er en tilstand, hvor patienten har episoder med højt humør (mani) eller lavt humør (depression) ud over symptomerne på skizofreni.
English: Studies have shown that Invega can reduce symptoms scores and prevent symptoms in patients with schizoaffective disorder.
Danish: Undersøgelser har vist, at Invega kan reducere symptomscoren og forhindre symptomer hos patienter med skizoaffektiv lidelse.
English: The European Medicines Agency decided that Invega's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Invega opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Invega.
English: Symptom scores fell by 19.9 points in those taking olanzapine.
Danish: Symptomscorerne faldt med 19,9 point hos dem, der fik olanzapin.
English: Paliperidone acts mainly by blocking the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin), which are involved in schizophrenia.
Danish: Paliperidon virker hovedsagelig ved at blokere receptorerne for neurotransmitterne dopamin og 5-hydroxytryptamin (også kaldet serotonin), der er medvirkende ved skizofreni.
English: After assessing the symptoms, the doctor may adjust the dose to between 3 and 12 mg once a day in adults with schizophrenia and to between 6 and 12 mg once a day in patients with schizoaffective disorder.
Danish: Efter vurdering af symptomerne kan lægen justere dosen til mellem 3 og 12 mg én gang dagligt hos voksne med skizofreni og til mellem 6 og 12 mg én gang dagligt hos patienter med skizoaffektiv lidelse.
English: In the brain, paliperidone attaches to several different receptors (targets) on nerve cells.
Danish: I hjernen bindes paliperidon til flere forskellige typer receptorer (mål) på nervecellerne.
English: Schizoaffective disorder
Danish: Skizoaffektiv lidelse
English: Invega must not be taken by people who are hypersensitive (allergic) to paliperidone or any of the other ingredients, or to risperidone.
Danish: Invega må ikke anvendes af personer, der er overfølsomme (allergiske) over for paliperidon eller andre af indholdsstofferne eller over for risperidon.
English: Invega is an antipsychotic medicine used in adults and adolescents from 15 years of age to treat schizophrenia, a mental illness with symptoms such as disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Danish: Invega er et antipsykotisk lægemiddel, der anvendes hos voksne og unge fra 15 år og derover til behandling af skizofreni, der er en psykisk lidelse med symptomer som f.eks. desorganiseret tankegang og tale, hallucinationer (opfattelsen af at høre eller se ting, som ikke er der), mistænksomhed og vrangforestillinger (ukorrekte forestillinger).
English: Invega is also used to treat adults with schizoaffective disorder.
Danish: Invega anvendes også til behandling af voksne med skizoaffektiv lidelse.
English: In an additional longer-term study involving 207 adults with schizophrenia who had initially been treated over 14 weeks, Invega was more effective than placebo in preventing new symptoms for up to 35 weeks.
Danish: I en yderligere, længerevarende undersøgelse med 207 voksne med skizofreni, som først var blevet behandlet gennem 14 uger, var Invega mere effektivt end placebo til at forhindre nye symptomer i op til 35 uger.
English: The active substance in Invega, paliperidone, is known as an ‘atypical' antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s.
Danish: Det aktive stof i Invega, paliperidon, kaldes et "atypisk" antipsykotisk lægemiddel, fordi det adskiller sig fra de ældre antipsykotiske lægemidler, der har været på markedet siden 1950'erne.
English: In a third study of 334 previously treated patients, symptoms of depression came back in 15% (25 out of 164) of patients given paliperidone compared with 34% (57 out of 170) of patients given placebo.
Danish: I en tredje undersøgelse med 334 tidligere behandlede patienter vendte symptomer på depression tilbage hos 15 % (25 ud af 164) af de patienter, der fik paliperidon, sammenholdt med 34 % (57 ud af 170) af de patienter, der fik placebo.
English: How is Invega used?
Danish: Hvordan anvendes Invega?
English: ‘Prolonged release' means that paliperidone is released slowly from the tablet over a few hours.
Danish: At tabletterne kaldes depottabletter betyder, at stoffet paliperidon langsomt frigives fra tabletten over nogle få timer.
English: Three short-term studies innvolving 1,692 adults showed that Invega is more effective than placebo (a dummy treatment) and as effective as another antipsychotic medicine olanzapine at reducing symptoms of schizophrenia (as measured by a standard rating scale).
Danish: Det er i tre korttidsundersøgelser med deltagelse af 1.692 voksne påvist, at Invega er mere effektivt end placebo (en uvirksom behandling) og lige så effektivt som et andet antipsykotisk lægemiddel (olanzapin) til at reducere symptomer på skizofreni (bedømt ved anvendelse af en standard scoreskala).
English: In another study, the fall in symptom score for mania after 6 weeks was 20.0 in the Invega group and 10.8 in the placebo group.
Danish: I en anden undersøgelse var faldet i symptomscoren for mani efter 6 uger 20,0 i Invega-gruppen og 10,8 i placebogruppen.
English: For more information about treatment with Invega, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Invega, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Studies in adolescents have shown similar results with Invega to those seen in adults.
Danish: Resultaterne af undersøgelser med Invega hos unge svarer til resultaterne hos voksne.
English: The most frequent side effects with Invega in adults are headache, insomnia (difficulty sleeping), sleepiness, parkinsonism (effects similar to Parkinson's disease such as shaking, muscle stiffness and slow movement), dystonia (involuntary muscle contractions), tremor (shaking), dizziness, akathisia (restlessness), agitation, anxiety, depression, increased weight, nausea, vomiting, constipation, dyspepsia (heartburn), diarrhoea, dry mouth, tiredness, toothache, muscle and bone pain, back pain, asthenia (weakness), tachycardia (increased heart rate), high blood pressure, prolonged QT interval (an alteration of the electrical activity of the heart), upper respiratory tract infection (nose and throat infections) and cough.
Danish: uro, angst, depression, vægtforøgelse, kvalme, opkastning, forstoppelse, halsbrand, diarré, mundtørhed, træthed, tandpine, muskel- og knoglesmerter, rygsmerter, svaghed, øget hjerterytme (takykardi), for højt blodtryk, forlænget QT-interval (en ændring af hjertets elektriske aktivitet), infektion i de øvre luftveje (i næsen eller halsen) og hoste.
English: Paliperidone is an active breakdown product (metabolite) of risperidone, another atypical antipsychotic medicine that has been used in the treatment of schizophrenia since the 1990s.
Danish: Paliperidon er et aktivt nedbrydningsprodukt (en metabolit) af risperidon, som er et andet atypisk antipsykotisk middel, der var været anvendt til behandling af skizofreni siden 1990'erne.
English: For practical information about using Invega, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Invega, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: In one of these studies, average symptom scores fell by between 17.9 and 23.3 points after 6 weeks in those taking Invega compared with a fall of 4.1 points with placebo.
Danish: I en af disse undersøgelser faldt de gennemsnitlige symptomscorer mellem 17,9 og 23,3 point efter 6 uger hos dem, der fik Invega, sammenholdt med et fald på 4,1 point hos dem, der fik placebo.
English: For the full list of all side effects reported with Invega, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Invega fremgår af indlægssedlen.
English: What benefits of Invega have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Invega?
English: The recommended starting dose of Invega in adults is 6 mg once a day, taken in the morning; the starting dose in adolescents is 3 mg daily.
Danish: Den anbefalede startdosis af Invega til voksne er 6 mg én gang dagligt om morgenen.
English: In one study, patients who were given Invega had a fall in their symptom score for mania of between 27.4 and 30.6 after 6 weeks compared with 21.7 in patients who were given placebo.
Danish: I en undersøgelse oplevede de patienter, som fik Invega, et fald i deres symptomscore for mani på mellem 27,4 og 30,6 efter 6 ugers behandling sammenholdt med 21,7 hos de patienter, der fik placebo.
English: How does Invega work?
Danish: Hvordan virker Invega?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Invega have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Invega.
English: This disrupts signals sent between brain cells by ‘neurotransmitters', substances that nerve cells use to communicate with neighbouring cells.
Danish: Derved afbrydes de signaler, som hjernecellerne sender til naboceller ved hjælp af signalstoffer (neurotransmittere).
English: In adolescents with schizophrenia the maximum daily dose depends on the patient's body weight and should not be more than 6 mg in those who weigh less than 51 kg. For more information on the use of Invega, including the adjustment of doses in those with kidney disease and the elderly, see the summary of product characteristics (also part of the EPAR).
Danish: Hos unge med skizofreni afhænger den maksimale daglige dosis af patientens kropsvægt og bør ikke overstige 6 mg hos patienter, der vejer under 51 kg.
English: It is given once daily for up to two weeks.
Danish: Det gives én gang dagligt i op til to uger.
English: This summary was last updated in July 2015.
Danish: Dette sammendrag blev senest ajourført i juli 2015.
English: The withdrawal period for meat from horses treated with Novaquin is three days.
Danish: Tilbageholdelsestiden for kød fra heste, der behandles med Novaquin, er tre dage.
English: This is a summary of the European public assessment report (EPAR) for Novaquin.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Novaquin.
English: It is either given with food or directly into the mouth at a dosage of 0.6 mg/kg bodyweight.
Danish: Det gives enten sammen med foderet eller direkte i dyrets mund i en dosering på 0,6 mg/kg kropsvægt.
English: The European Commission granted a marketing authorisation valid throughout the EU for Novaquin on 8 September 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Novaquin den 8. september 2015.
English: It contains the active substance meloxicam.
Danish: Det indeholder det aktive stof meloxicam.
English: The full EPAR for Novaquin can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Novaquin findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Other information about Novaquin
Danish: Andre oplysninger om Novaquin
English: The Committee recommended that Novaquin be approved for use in the EU.
Danish: Udvalget anbefalede, at Novaquin godkendes til anvendelse i EU.
English: Novaquin is a ‘generic medicine'.
Danish: Novaquin er et "generisk lægemiddel".
English: This means that Novaquin is similar to a ‘reference medicine' already authorised in the European Union (EU) called Metacam.
Danish: Det betyder, at Novaquin svarer til et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Metacam.
English: What are the benefits and risks of Novaquin?
Danish: Hvilke fordele og risici er der forbundet med Novaquin?
English: Novaquin is available as a 15 mg/ml oral suspension and can only be obtained with a prescription.
Danish: Novaquin fås som en oral suspension, 15 mg/ml, og udleveres kun efter recept.
English: It is not intended to provide practical advice on how to use Novaquin.
Danish: Det er ikke en praktisk vejledning i, hvordan Novaquin bør anvendes.
English: Novaquin contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Danish: Novaquin indeholder meloxicam, som tilhører lægemiddelgruppen ikke-steroide antiinflammatoriske lægemidler (NSAID).
English: What is Novaquin and what is it used for?
Danish: Hvad er Novaquin, og hvad anvendes det til?
English: Meloxicam acts by blocking an enzyme called cyclooxygenase which is involved in the production of prostaglandins.
Danish: Meloxicam virker ved at blokere enzymet cyclooxygenase, der medvirker ved produktionen af prostaglandiner.
English: The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter indgivelsen af et lægemiddel, før et dyr kan slagtes, og kødet kan anvendes til menneskeligt konsum.
English: It is also the time required after administration of a medicine before milk or eggs may be used for human consumption.
Danish: Det er også den tid, der skal gå efter indgivelsen af et lægemiddel, før mælk eller æg kan anvendes til menneskeligt konsum.
English: It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use.
Danish: Det forklarer, hvordan agenturet vurderede dette lægemiddel til dyr for at kunne anbefale udstedelse af en markedsføringstilladelse og fastlægge anvendelsesbetingelserne.
English: The precautions are the same as for the reference medicine since Novaquin is a generic medicine.
Danish: Disse forholdsregler er de samme som for referencelægemidlet, eftersom Novaquin er et generisk lægemiddel.