FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Rivastigmine Sandoz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Rivastigmine Sandoz, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: An additional study in 27 patients was used to show that Rivastigmine Sandoz capsules and oral solution produced similar levels of the active substance in the blood.
Danish: I endnu en undersøgelse hos 27 patienter blev det vist, at Rivastigmine Sandoz-kapsler og oral opløsning giver samme indhold af aktivt stof i blodet.
English: Treatment with Rivastigmine Sandoz should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease or dementia in patients with Parkinson's disease.
Danish: Behandlingen med Rivastigmine Sandoz bør indledes og overvåges af en læge med erfaring i diagnosticering og behandling af Alzheimers sygdom eller demens hos patienter med Parkinsons sygdom.
English: This authorisation was based on the authorisation granted to Exelon in 1998 (‘informed consent').
Danish: Denne markedsføringstilladelse er baseret på den markedsføringstilladelse, der blev udstedt for Rivastigmine Sandoz i 1998 (”informeret samtykke”).
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Rivastigmine Sandoz by the patient.
Danish: Behandling bør kun indledes, hvis patienten har en plejer, der regelmæssigt overvåger patientens indtagelse af Rivastigmine Sandoz.
English: Overall, the most common side effects (seen in more than 1 patient in 10) include nausea (feeling sick, seen in 38 patients in 100) and vomiting (seen in 23 patients in 100), particularly during the phase when the dose of Rivastigmine Sandoz is being increased.
Danish: Som helhed er de mest almindelige bivirkninger kvalme (som optræder hos 38 ud af 100 patienter) og opkastning (som optræder hos 23 ud af 100 patienter), især i den fase, hvor Rivastigmine Sandoz-dosen øges.
English: Rivastigmine Sandoz was more effective than placebo at controlling symptoms.
Danish: Rivastigmine Sandoz var mere effektivt end placebo til at begrænse symptomerne.
English: Rivastigmine Sandoz is a medicine containing the active substance rivastigmine.
Danish: Rivastigmine Sandoz er et lægemiddel, der indeholder det aktive stof rivastigmin.
English: Rivastigmine Sandoz is used for the treatment of patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Danish: Rivastigmine Sandoz anvendes til behandling af patienter med let til middelsvær Alzheimers sygdom, en fremadskridende hjernesygdom, der gradvis angriber hukommelse, intellektuelle evner og adfærd.
English: Rivastigmine Sandoz was also studied in 541 patients with dementia due to Parkinson's disease.
Danish: Rivastigmine Sandoz blev desuden undersøgt hos 541 patienter med demens som følge af Parkinsons sygdom.
English: Other information about Rivastigmine Sandoz
Danish: Andre oplysninger om Rivastigmine Sandoz
English: Rivastigmine Sandoz has been studied in three main studies involving 2,126 patients with mild to moderately severe Alzheimer's disease.
Danish: Rivastigmine Sandoz blev undersøgt i tre hovedundersøgelser med 2 126 patienter med let til middelsvær Alzheimers sygdom.
English: Therefore, the Committee decided that Rivastigmine Sandoz's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget var derfor af den opfattelse, at fordelene ved Rivastigmine Sandozopvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Rivastigmine Sandoz must not be used in people who are hypersensitive (allergic) to rivastigmine, other carbamate derivatives or any of the other ingredients.
Danish: Rivastigmine Sandoz bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for rivastigmin, andre stoffer afledt af carbamat eller andre af indholdsstofferne.
English: For the full list of all side effects reported with Rivastigmine Sandoz, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Rivastigmine Sandoz fremgår af indlægssedlen.
English: The active substance in Rivastigmine Sandoz, rivastigmine, is an antidementia medicine.
Danish: Det aktive stof i Rivastigmine Sandoz, rivastigmin, er et middel til behandling af demens.
English: The patients with dementia due to Parkinson's disease taking Rivastigmine Sandoz capsules showed an improvement in cognitive symptoms of 2.1 points, compared with a worsening of 0.7 points in those taking placebo, from a baseline of around 24 points.
Danish: Af de patienter, der havde demens som følge af Parkinsons sygdom, gav Rivastigmine Sandoz-kapsler en bedring i de kognitive symptomer på 2,1 points, sammenholdt med en forværring på 0,7 points hos dem, der fik placebo.
English: The global symptom score also improved more in the patients taking Rivastigmine Sandoz.
Danish: Også i score vedrørende overordnede funktioner var der større bedring hos de patienter, der fik Rivastigmine Sandoz.
English: In the three studies of Rivastigmine Sandoz in patients with Alzheimer's dementia, patients taking doses of Rivastigmine Sandoz between 6 and 9 mg per day had an average increase in cognitive symptoms of 0.2 points from a baseline of 22.9 points at the start of the study, where a lower score indicates better performance.
Danish: Hos de patienter, der fik Rivastigmine Sandoz, 6 til 9 mg dagligt, øgedes de kognitive symptomer med 0,2 points fra et udgangspunkt på 22,9 points ved undersøgelsens start (lavere score = bedre præstationer).
English: The CHMP concluded that Rivastigmine Sandoz has a modest effectiveness in treating the symptoms of Alzheimer's dementia, although this does reflect an important benefit in some patients.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at virkningen af Rivastigmine Sandoz på symptomerne på Alzheimers sygdom er beskeden, men at den hos nogle patienter er vigtig.
English: All of the studies lasted six months and compared the effects of Rivastigmine Sandoz with those of placebo (a dummy treatment).
Danish: I dem alle blev virkningerne af Rivastigmine Sandoz sammenlignet med virkningerne af placebo (virkningsløs behandling).
English: The Committee initially concluded that for the treatment of dementia due to Parkinson's disease, Rivastigmine Sandoz's benefits did not outweigh its risks.
Danish: Udvalget konkluderede først, at fordelene ved Rivastigmine Sandoz ikke opvejer risiciene til behandling af demens ved Parkinsons sygdom.
English: What is the risk associated with Rivastigmine Sandoz?
Danish: Hvilken risiko er der forbundet med Rivastigmine Sandoz?
English: The types of side effects seen with Rivastigmine Sandoz depend on the type of dementia it is being used to treat.
Danish: Bivirkningerne af Rivastigmine Sandoz afhænger af den form for demens, patienten har.
English: Why has Rivastigmine Sandoz been approved?
Danish: Hvorfor blev Rivastigmine Sandoz godkendt?
English: What is Rivastigmine Sandoz?
Danish: Hvad er Rivastigmine Sandoz?
English: How has Rivastigmine Sandoz been studied?
Danish: Hvordan blev Rivastigmine Sandoz undersøgt?
English: By blocking these enzymes, Rivastigmine Sandoz allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia and dementia due to Parkinson's disease.
Danish: Ved at blokere disse enzymer øger Rivastigmine Sandoz hjernens indhold af acetylcholin.
English: What benefit has Rivastigmine Sandoz shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Rivastigmine Sandoz?
English: For the global score, patients taking Rivastigmine Sandoz had an increase in symptoms of 4.1 points, compared with 4.4 in those taking placebo.
Danish: For score vedrørende overordnede funktioner var der en stigning på 4,1 points hos patienterne på Rivastigmine Sandoz.
English: Rivastigmine Sandoz is also used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Danish: Det kan desuden anvendes til behandling af let til middelsvær demens hos patienter med Parkinsons sygdom.
English: What is Rivastigmine Sandoz used for?
Danish: Hvad anvendes Rivastigmine Sandoz til?
English: How is Rivastigmine Sandoz used?
Danish: Hvordan anvendes Rivastigmine Sandoz?
English: A proposal should be provided.
Danish: Der kræves et forslag.
English: Do not use after the expiry date which is stated on the label.
Danish: Anvendes ikke efter den udløbsdato, der er angivet på etiketten.
English: Stability
Danish: STABILITET
English: The specified timeframe for all specific obligations is that a first update on the progress of the fulfilment of the specific obligations is expected to be received by the CVMP by 1 October 2007.
Danish: Den specificerede tidsramme for alle specifikke forpligtelser er, at den første opdatering af udførelse af fremskridt af de specifikke forpligtelser forventes modtaget af CVMP den 1. oktober 2007.
English: CONTROL TESTS ON THE FINISHED PRODUCT
Danish: KONTROLTEST AF DET FÆRDIGE PRODUKT
English: The level of efficacy for other species may differ from that observed in chickens.
Danish: Graden af effekt på andre arter kan være forskellig fra, hvad der er observeret i kyllinger.
English: Pharmacotherapeutic group: inactivated vaccine, ATC-vet code: QI01AA23
Danish: Farmakoterapeutisk gruppe: Inaktiveret vaccine, ATCvet-kode: QI01AA23
English: It is recommended to use a closed multidose vaccination system.
Danish: Det anbefales at bruge et lukket multiinjektions-vaccinationssystem.
English: MARKETING AUTHORISATION NUMBER EU/2/07/076/001-004
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/07/076/001-004
English: PET vials: 2 years Glass vials: 1 year
Danish: PET-flasker: 2 år Hætteglas: 1 år
English: ANALYTICAL ASPECTS
Danish: ANALYTISKE ASPEKTER
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
Danish: I henhold til artikel 71 i Europarådets direktiv 2001/82/EC kan en medlemsstat forbyde indførsel, salg, levering og/eller anvendelse af veterinærlægemidlet på hele eller en del af sit område, hvis det godtgøres:
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Following the administration of a double dose no adverse reactions other than those described in section 4.6 have been observed.
Danish: 4.10 Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt Der er ikke observeret andre symptomer efter administration af dobbelt dosis end dem, der er beskrevet i afsnit 4.6.
English: Sorbitane mono-oleate Glycine
Danish: Sorbitan mono-oleat Glycin
English: All food producing species All food producing species
Danish: Alle fødevareproducerende dyr Alle fødevareproducerende dyr Alle fødevareproducerende dyr Alle fødevareproducerende dyr
English: After broaching, use within 8 hours, provided the product is not subject to extreme temperatures or contaminated.
Danish: Bruges inden for 8 timer efter anbrud under forudsætning af at produktet ikke er udsat for ekstreme temperaturer eller kontaminering.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur (EMEA) http://www.emea.europa.eu/.
English: Any person intending to import, sell, supply and/or use Nobilis Influenza H5N6 must consult the relevant Member State's competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Danish: Enhver person, som har til hensigt at indføre, sælge, levere og/eller anvende Nobilis Influenza H5N6, skal rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik inden indførsel, salg, levering og/eller anvendelse finder sted.
English: The antigen should be stored for no longer than 12 months at 2-8ºC pending the provision of data supporting a longer period of storage.
Danish: Antigenet må ikke opbevares længere end 12 måneder ved 2 - 80C i afventen af yderligere data til støtte for en længere opbevaringsperiode.
English: b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
Danish: b) At den sygdom, som lægemidlet er beregnet til at fremkalde immunitet mod, stort set ikke forekommer i det pågældende område.
English: Test for identification: A final product batch test should be introduced to identify the neuraminidase component and confirm that the vaccine has the correct composition.
Danish: Test til identifikation: Der skal indføres en test på den færdige batch til identifikation af neuraminidase-komponenten, og til bekræftelse af, at vaccinen har den korrekte sammensætning.
English: The bottles are closed with a nitryl rubber stopper and sealed with a coded aluminium cap.
Danish: Flaskerne er lukket med nitryl-gummiprop og forseglet med kodet aluminiumshætte.
English: The Applicant is required to submit 3-montly Periodic Update Safety reports for the first 2 years following the initial use in the field and is additionally required to present a protocol that would ensure adequate recording and reporting of field data in relation to suspected adverse reactions including suspected lack of efficacy.
Danish: Ansøgeren skal fremsende periodiske sikkerhedsopdateringer hver 3. måned i de første 2 år, som følger anvendelsen i felten fra starten, og er yderligere forpligtet til at præsentere en protokol, som garanterer fornøden opsamling og rapportering af feltdata i relation til formodede bivirkninger, der inkluderer formodet manglende virkning.
English: a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Danish: a) At behandling af dyr med lægemidlet griber forstyrrende ind i gennemførelsen af et nationalt program til diagnosticering, bekæmpelse eller udryddelse af sygdomme hos dyr eller gør det vanskeligt at bekræfte, at levende dyr eller levnedsmidler eller andre produkter, hidrørende fra behandlede dyr, ikke er kontamineret.
English: Do not freeze.
Danish: Må ikke fryses eller udsættes for frost.
English: Up-todate information should be provided on the source countries of origin of the animals supplying the milk for preparation of the Tryptose from BD Biosciences and for the preparation of the casein, and lactose where appropriate, for manufacture of the NZ-Amines purchased from Quest/Kerry.
Danish: Der skal fremsendes opdaterede informationer mht. oprindelsesland for de dyr, som leverer mælk til produktionen af Tryptose fra BD Biosciences og for fremstillingen af kasein og laktose, hvor det er passende, til fremstillingen af NZ-aminer, der er købt hos Quest/Kerry.
English: II.E.2 Identification and assay of active ingredients
Danish: II.E.2 Identifikation og styrkebestemmelse af aktive indholdsstoffer
English: If used in other avian species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of birds prior to mass vaccination.
Danish: Hvis vaccinen bruges til andre fuglearter, som er i risiko for infektion, skal vaccinationen af disse fuglearter foretages med forsigtighed, og det er tilrådeligt at teste vaccinen på et lille antal fugle før massevaccination.
English: Specific Measures concerning the prevention of the transmission of animal spongiform encephalopathies
Danish: Specifikke målinger vedrørende forebyggelse af overførsel af spongiform encephalopatier fra dyr
English: 4.6 Adverse Reactions (frequency and seriousness)
Danish: 4.6 Bivirkninger (forekomst og sværhedsgrad)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Influenza H5N6
Danish: VETERINÆRLÆGEMIDLETS NAVN Nobilis Influenza H5N6
English: MANUFACTURER'S BATCH NUMBER Lot {number}
Danish: FREMSTILLERENS BATCHNUMMER Batch nr. {nummer}
English: This vaccine has been tested for safety in chickens and only some supportive data for safety in ducks are available.
Danish: Vaccinen er testet for sikkerhed i kyllinger og nogle støttende data er tilgængelige om sikkerhed i ænder.
English: The import, sale, supply and/or use of Nobilis Influenza H5N6 is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Danish: Indførsel, salg, levering og/eller anvendelse af Nobilis Influenza H5N6 er eller kan være forbudt i visse medlemsstater på dele af eller hele deres område.
English: II.E.9 Batch to batch consistency
Danish: II.E.9 Batch-til-batch overensstemmelse
English: From 8-14 days old: 0.25 ml subcutaneously
Danish: Fra 8-14 dage gamle: 0,25 ml subkutant
English: The following substances contained in the final product are included in Annex II of Council Regulation (EEC) No 2377/90:
Danish: D. ANGIVELSE AF MRL-VÆRDIER Følgende substanser i det færdige lægemiddel er medtaget i Annex II til Rådets forordning (EØF) nr.
English: Tryptose: The Applicant should provide a list of suitable source countries for the pigs used as a source of the porcine starting material in tryptose.
Danish: Tryptose: Ansøgeren skal fremkomme med en liste over egnede lande, hvor de svin som anvendes til fremstilling af tryptose, kan komme fra.
English: Results should be provided for final product tests on three batches of Nobilis Influenza H5N6, to demonstrate batch consistency.
Danish: Resultater skal fremsendes fra test af 3 batch af det færdige produkt Nobilis Influenza H5N6 for at bevise overensstemmelse af batch.
English: If the circulating avian influenza field virus has a different N component to the N6 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic test to detect neuraminidase antibodies.
Danish: Hvis det cirkulerende vilde fugleinfluenza-virus har en anden N-komponent i forhold til N6, som findes i vaccinen, er det muligt at differentiere mellem vaccinerede og inficerede fugle, ved at bruge en diagnostisk test til bestemmelse af neuraminidase-antistoffer.
English: 250 ml or 500 ml bottles of glass, hydrolytical class type II or of polyethylene terephthalate (PET).
Danish: 250 ml og 500 ml flasker af hydrolytisk glas type II eller af polyethylenterephthalat (PET).
English: Immunisation of progeny from vaccinated birds should therefore be delayed until such antibodies have declined.
Danish: Immunisering af afkom af vaccinerede fugle bør derfor udsættes, indtil dette antistofniveau er faldet.
English: If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Danish: Hvis du ved et uheld injiceres med dette produkt, skal du søge omgående lægehjælp, også selvom det kun drejer sig om en meget lille mængde, og tage indlægssedlen med dig.
English: A transient diffuse swelling may occur at the vaccination site in 50% of the animals, which persists for about 14 days.
Danish: Hos 50 % af kyllingerne kan der opstå en forbigående hævelse, som varer i cirka 14 dage.
English: The Applicant should agree to specify the NZ-Amine(s) used in production and only to source Tryptose and these specified NZ-Amine(s) from specified companies from whom suitable ‘milk statements' have been submitted in the dossier, together with details of the countries of origin of the source animals.
Danish: Ansøgeren må kun anvende Tryptose og (specificeret) NZ-aminer, der stammer fra specificerede firmaer, hvorfra der er fremsendt ”milk statement” i dossiet, sammen med detaljer vedr.
English: E. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
Danish: E. SPECIFIKKE FORPLIGTELSER, SOM SKAL OPFYLDES AF INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: Liquid light paraffin Polysorbate 80
Danish: Paraffinolie, tynd Polysorbat 80
English: Store refrigerated (2°C to 8°C).
Danish: Opbevares i køleskab (2°C til 8°C).
English: The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/risk profile.
Danish: Resultaterne af undersøgelserne vil danne grundlaget for den årlige revurdering af benefit/risk-forholdet.
English: Pharmacologically active substance Animal Species
Danish: De farmakologisk aktive stoffer
English: Name and address of the manufacturer of the biological active substance
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof(fer)
English: Serum antibodies have been shown to persist in chickens for at least 7 months and studies performed with other vaccine strains show that serum antibodies would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine.
Danish: Serumantistoffer er vist at være vedvarende i kyllinger i mindst 7 måneder og undersøgelser udført med andre vaccinestammer viser at serum antistoffer forventes at vedvare i kyllinger i mindst 12 måneder efter indgivelser af to vaccinationer.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular or subcutaneous injection of 0.25 or 0.5 ml, depending on the age.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Intramuskulær eller subkutan injektion af 0,25;0,5 ml eller 1 ml afhængig af alder og art.
English: PACKAGE SIZE 250 ml
Danish: PAKNINGSSTØRRELSE 250 ml
English: Adjuvant: Liquid light paraffin 234.8 mg/0.5 ml
Danish: Adjuvans: Paraffinolie, tynd 234,8 mg/0,5 ml
English: For a full list of excipients see section 6.1
Danish: Se afsnit 6.1 for en fuldstændig fortegnelse over hjælpestoffer.
English: 250 or 500 ml multidose glass bottle 250 or 500 ml multidose PET bottle The bottles are closed with a rubber stopper and an aluminium cap.
Danish: 250 ml eller 500 ml multidosis PET flasker Flaskerne er lukket med gummiprop og en aluminiumskappe.
English: Chickens
Danish: Kyllinger.
English: The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Avian Influenza.
Danish: Anvendelsen af dette veterinærlægemiddel er kun tilladt under specielle forhold fastsat af Det Europæiske Fællesskabs lovgivning om kontrollen af fjerkræinfluenza.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 250 ml
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: The use of this veterinary medicnal product is only allowed under the particular conditions established by the European Community legislation on the control of Avian Influenza.
Danish: Brugen af dette veterinære produkt er kun tilladt under særlig betingelser udstedt i lovgivningen fra den Europæiske fællesskab om kontrol af fugleinfluenza.
English: Inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/duck/Potsdam/2243/84), inducing an HI titre of ≥6.0 log2 as tested according to the potency test.
Danish: Inaktiveret helt fugleinfluenza-virusantigen af undertype H5 (stamme H5N6, A/duck/Potsdam/1402/86), inducerer en HI titer på > 6.0 log2 som testet i henhold til potency test.
English: From 14 days to 6 weeks old: 0.25 or 0.5 ml subcutaneously or intramuscularly 6 weeks and older: 0.5 ml subcutaneously or intramuscularly Future laying hens and breeders should get a second vaccination 4-6 weeks after first vaccination.
Danish: Fra 14 dage til 6 uger gamle: 0,25 ml eller 0,5 ml subkutant eller intramuskulært 6 uger og ældre: 0,5 ml subkutant eller intramuskulært Kommende æglæggere og avlsdyr bør gives en anden vaccination 4 - 6 uger efter første vaccination.