FrancophonIA/ELRC3.0 huggingface dataset:
English: Cattle from 6 weeks of age: subcutaneous injection of two doses of 1 ml, administered with an interval of approximately 3 weeks.
Danish: Kvæg fra 6-ugers-alderen gives to subkutane vaccinationer a 1 ml med et interval på ca. 3 uger.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (10, 20, 50, 100, 200, 250 or 500 ml) PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vials (100, 200, 250 or 500 ml PET vials)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton æske (10, 20, 50, 100, 200, 250 eller 500 ml)
English: To stimulate active immunity in sheep from 1 month of age against bluetongue virus serotype 8 to prevent viraemia*.
Danish: Til stimulation af aktiv beskyttelse af får fra 1 måneds-alderen mod bluetonguevirus serotype 8 for at undgå viræmi*.
English: Sheep from 1 month of age: subcutaneous injection of a single dose of 1 ml.
Danish: Får fra 1 måneds-alderen gives en subkutan vaccination med en enkelt dosis a 1 ml.
English: To stimulate active immunity in cattle from 6 weeks of age against bluetongue virus serotype 8 to reduce viraemia*.
Danish: Til stimulation af aktiv beskyttelse af kalve fra 6-ugers-alderen mod bluetonguevirus serotype 8 for at begrænse viræmi*.
English: After administration of a double dose in cattle and sheep no other reactions were observed.
Danish: Der er ikke observeret bivirkninger efter brug af dobbelt dosis til kvæg og får ud over dem der er beskrevet.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Trometamol
Danish: 6.1 Fortegnelse over hjælpestoffer
English: In cattle small palpable swellings may still be present up to six weeks after vaccination in approximately one third of the vaccinated animals.
Danish: Hos ca. 1/3 af de vaccinerede kvæg kan der mærkes små hævelser i op til 6 uger.
English: Active ingredient: bluetongue virus serotype 8: 500 antigenic units* (* inducing a virus neutralising antibody response in chickens of ≥ 5.0 log2) Adjuvants: aluminium hydroxide, saponin.
Danish: (* inducerer et virusneutralisations antistofrespons i kyllinger på > 5,0 log2) Adjuvanser: aluminiumhydroxid, saponin
English: Sheep from 1 month of age: injection of a single dose of 1 ml.
Danish: Får fra 1 måneds-alderen gives en vaccination med en enkelt dosis a 1 ml.
English: ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: A. FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG INDEHAVER(E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton after EXP.Once broached use within 8 hours, provided the product is not subject to temperatures above 37 °C or contaminated.
Danish: Må ikke anvendes efter den udløbsdato, som er angivet på etiketten efter UDL.D.
English: The list of examples of contraindicated combinations considered essential for
Danish: Listen over eksempler på kontraindicerede kombinationer, hvor det skønnes vigtigt,
English: However specific guidance on switching from other antipsychotics has not been proposed due to limited data.
Danish: Der er imidlertid ikke foreslået specifik vejledning vedrørende skift fra andre antipsykotika på grund af begrænsede data.
English: Annex II Scientific conclusions
Danish: Bilag II Videnskabelige konklusioner
English: Contraindications relating to children less than 3 years of age and breastfeeding women were not included due to the lack of adequate data to support such contraindications.
Danish: Kontraindikationer vedrørende børn under 3 år og ammende kvinder blev ikke indføjet på grund af manglen på relevante data, der understøtter sådanne kontraindikationer.
English: Also patients with severe renal impairment may require a lower initial dose, with subsequent adjustments.
Danish: Desuden kan patienter med svært nedsat nyrefunktion have behov for en lavere begyndelsesdosis med efterfølgende justering.
English: Overall summary of the scientific evaluation by the CHMP
Danish: Samlet resumé af CHMP's videnskabelige vurdering
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product (and its associated names), the European Commission (EC) notified the European Medicines Agency's Secretariat of an official referral under Article 30 of Directive 2001/83/EC in order to resolve the divergences amongst the nationally approved SmPCs and thus to harmonise its divergent SmPCs across the EU.
Danish: På grund af de divergerende nationale afgørelser, der er truffet af medlemsstaterne ved godkendelsen af det ovennævnte produkt (og relaterede navne), foretog Europa-Kommissionen en officiel indbringelse for Det Europæiske Lægemiddelagenturs sekretariat i medfør af artikel 30 i direktiv 2001/83/EF for at få løst uoverensstemmelserne mellem de nationalt godkendte produktresuméer og dermed harmonisere produktresuméerne i EU.
English: Haldol Decanoate has been approved nationally in the EU with many differences in the wording of the summary of product characteristics (SmPC), in the various Member States.
Danish: Haldol Decanoate er godkendt nationalt i EU, og der er mange forskelle i ordlyden af produktresuméerne i de forskellige medlemsstater.
English: In patients with hepatic impairment, it is recommended to halve the initial dose, since haloperidol is extensively metabolised in the liver.
Danish: Hos patienter med nedsat leverfunktion anbefales det at halvere begyndelsesdosen, da haloperidol i vid udstrækning metaboliseres i leveren.
English: Based on the review of all available data and the consultations with the Healthcare Professionals Organisations (HCPOs), the CHMP recommended the following revision and harmonisation of the product information for Haldol Decanoate and associated names.
Danish: Baseret på gennemgangen af alle tilgængelige data og efter samråd med de sundhedsfaglige organisationer anbefalede CHMP følgende ændringer for at harmonisere produktinformationen for Haldol Decanoate og relaterede navne.
English: The contraindications in section 4.3 were also amended to include the wording related to the contraindication of cardiotoxic risk of haloperidol.
Danish: 4.3 blev også ændret, idet ordlyden for kontraindikationen vedrørende kardiotoksisk risiko for haloperidol blev indføjet.
English: The active substance haloperidol is a potent central dopamine type 2 receptor antagonist, lacking antihistaminergic or anticholinergic activity at recommended doses, and exerts minimal alpha 1 adrenergic activity.
Danish: Det aktive stof, haloperidol, er en potent central dopamin type 2receptorantagonist, der ikke har nogen antihistaminerg eller antikolinerg aktivitet, og som har en minimal alfa 1-adrenerg aktivitet.
English: The final indication agreed for Haldol decanoate is for the maintenance treatment of schizophrenia and schizoaffective disorder in adult patients currently stabilised with oral haloperidol.
Danish: Den endelige vedtagne indikation for Haldol Decanoate er vedligeholdelsesbehandling af skizofreni og skizoaffektiv lidelse hos voksne patienter, der aktuelt er stabiliseret med oralt haloperidol.
English: Haldol Decanoate - an ester of haloperidol and decanoic acid, is a depot antipsychotic belonging to the butyrophenone group.
Danish: Haldol Decanoate, der er en ester af haloperidol og decansyre, er et antipsykotisk depotlægemiddel, der tilhører butyrophenon-gruppen.
English: As Haldol Decanoate is an injectable long-acting depot formulation recommended to be used every 4 weeks, in order to avoid medication errors in which either haloperidol injectable or haloperidol decanoate are administered in error, the MAH has committed to conduct further post-marketing safety analysis after completion of the Art 30 referral, while assessing the need for changing the name of the medicinal product thereafter.
Danish: Da Haldol Decanoate er en injicerbar langtidsvirkende depotformulering, der anbefales til brug hver 4. uge, og for at undgå medicineringsfejl, hvor enten injicerbar haloperidol eller haloperidoldecanoat administreres ved en fejl, har indehaveren af markedsføringstilladelse forpligtet sig til at gennemføre en ekstra postmarketing-sikkerhedsanalyse efter afslutningen af artikel 30-indbringelsesproceduren, samtidig med at det vurderes, om der derefter er behov for at skifte lægemidlets navn.
English: Given that the maximum dose of oral haloperidol in the elderly is 5 mg/day and applying the conversion factor of 15, the maximum haloperidol decanoate dose must not be in excess of 75 mg/4wk in the elderly unless elderly patients have already received higher haloperidol (oral or decanoate) doses for long-standing schizophrenia with acceptable tolerability.
Danish: Da den maksimale dosis oralt haloperidol hos ældre er 5 mg/dag, må den maksimale dosis haloperidoldecanoat, under anvendelse af konverteringsfaktoren på 15, ikke overstige 75 mg for en 4-ugers periode hos ældre, medmindre de allerede har fået høje doser haloperidol (oralt eller som decanoat) mod længerevarende skizofreni med acceptabel tolerabilitet.
English: After intramuscular injection (IM), Haldol Decanoate is gradually released from muscle tissue and hydrolysed slowly into free haloperidol, which enters the systemic circulation.
Danish: Efter intramuskulær injektion frigives Haldol Decanoate gradvist fra muskelvævet, hvorefter det hydrolyseres langsomt til frit haloperidol, der går ind i det systemiske kredsløb.
English: The proposal for the posology wording in section 4.2 has been revised with regard to transition from oral haloperidol, continuation of treatment, and supplementation with non-decanoate haloperidol up to the maximum oral dose, in adults and the elderly.
Danish: 4.2 er blevet revideret i forhold til skifte fra oralt haloperidol, fortsættelse af behandling og supplering med non-decanoat-haloperidol op til den maksimale orale dosis hos voksne og ældre.
English: Based on clinical trial data, guideline recommendations and expert consultations by the marketing authorisation holder (MAH) and by the HCPOs, a conversion factor of 10 to 15 is supported when switching from oral haloperidol to the longacting injectable (LAI) Haldol Decanoate.
Danish: På grundlag af data fra kliniske undersøgelser, anbefalinger i behandlingsvejledninger og eksperthøringer, som indehaveren af markedsføringstilladelse og de sundhedsfaglige organisationer har gennemført, er der fundet dokumentation for en konverteringsfaktor på 10-15 ved skifte fra oralt haloperidol til det langtidsvirkende injicerbare Haldol Decanoate.
English: A critical evaluation of the MAH's proposed harmonised SmPC is discussed below.
Danish: Nedenfor følger en kritisk vurdering af de harmoniserede produktresuméer, som indehaveren af markedsføringstilladelse har foreslået.
English: It is given independent of meals and preferably at the same time each day.
Danish: Det gives uafhængigt af måltider og fortrinsvis på samme tidspunkt hver dag.
English: Patients were followed up on average for 3.8 years.
Danish: Patienterne blev i gennemsnit fulgt i 3,8 år.
English: These side effects usually pass after a few days or weeks of treatment.
Danish: Disse bivirkninger fortager sig som regel efter få dages eller ugers behandling.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Victoza on 30 June 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Victoza den 30. juni 2009.
English: The full EPAR for Victoza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Victoza 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 Victoza.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Victoza.
English: Victoza liraglutide
Danish: Victoza liraglutid
English: • as an ‘add-on' to other diabetes medicines.
Danish: • som tillægsbehandling til andre diabeteslægemidler.
English: Cardiovascular events occurred in 13% (608 out of 4668) of patients taking Victoza compared with 14.9% (694 out of 4672) of patients taking placebo.
Danish: Der opstod hjerte-kar-hændelser hos 13 % (608 ud af 4 668) af de patienter, der fik Victoza, sammenlignet med 14,9 % (694 ud af 4 672) af dem, der fik placebo.
English: Victoza was compared with placebo and all patients also received standard care.
Danish: Victoza blev sammenlignet med placebo, og alle patienter modtog også standardpleje.
English: The study involved 9,340 patients with type 2 diabetes who already had cardiovascular disease (such as angina, heart attack or stroke).
Danish: Undersøgelsen omfattede 9 340 patienter med type 2sukkersyge, som allerede led af hjerte-kar-sygdomme (såsom angina, hjerteanfald eller slagtilfælde).
English: HbA1c gives an indication of how well the blood glucose is controlled.
Danish: HbA1c giver en indikation af, hvor godt glukosen i blodet reguleres.
English: Other information about Victoza
Danish: Andre oplysninger om Victoza
English: In some patients, the dose can be further increased to 1.8 mg one week later to achieve better control of blood glucose.
Danish: Hos nogle patienter kan dosis øges yderligere til 1,8 mg en uge senere for at opnå en bedre regulering af blodsukkeret.
English: • on its own when use of metformin (another medicine for type 2 diabetes) is not recommended;
Danish: • alene, når anvendelse af metformin (et andet lægemiddel mod type 2-sukkersyge) ikke anbefales
English: This means that it acts in the same way as incretins (hormones produced in the gut) by increasing the amount of insulin released by the pancreas in response to food.
Danish: Det betyder, at det virker på samme måde som inkretiner (hormoner, der produceres i tarmene), nemlig ved at øge mængden af insulin fra bugspytkirtlen som reaktion på mad.
English: What measures are being taken to ensure the safe and effective use of Victoza?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Victoza?
English: The European Medicines Agency decided that Victoza's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Victoza opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Victoza.
English: Victoza is given by the patient once a day by injection under the skin in the abdomen, thigh or upper arm.
Danish: Victoza gives af patienten en gang dagligt ved injektion under huden i maven, låret eller overarmen.
English: The main measure of effectiveness was the occurrence of one of three major cardiovascular events: stroke, heart attack or death caused by cardiovascular disease.
Danish: Virkningen blev hovedsageligt bedømt på forekomsten af én af tre alvorlige hjerte-kar-hændelser, nemlig slagtilfælde, hjerteanfald eller dødsfald forårsaget af hjerte-kar-sygdom.
English: Victoza was effective at controlling blood glucose in six main studies involving 4,155 adults with type 2 diabetes.
Danish: Victoza var effektivt til at regulere blodsukkeret i seks hovedundersøgelser, hvori der deltog 4 155 voksne med type 2-sukkersyge.
English: The most common side effects with Victoza (seen in more than 1 patient in 10) are nausea and diarrhoea.
Danish: De hyppigste bivirkninger ved Victoza (som optræder hos flere end 1 ud af 10 patienter) er kvalme og diarré.
English: What is Victoza and what is it used for?
Danish: Hvad er Victoza, og hvad anvendes det til?
English: Why is Victoza approved?
Danish: Hvorfor blev Victoza godkendt?
English: Victoza is a medicine used in addition to diet and exercise in adults who have type 2 diabetes.
Danish: Victoza er et lægemiddel, som anvendes som supplement til diæt og motion hos voksne med type 2sukkersyge.
English: In these studies, the main measure of effectiveness was the reduction in the amount of a substance in the blood called glycosylated haemoglobin (HbA1c) after six months or one year of treatment.
Danish: I disse undersøgelser blev behandlingens virkning hovedsagelig bedømt på faldet i mængden af et stof i blodet kaldet glykosyleret hæmoglobin (HbA1c) efter seks måneders eller et års behandling.
English: It is not intended to provide practical advice on how to use Victoza.
Danish: Det er ikke en praktisk vejledning i, hvordan Victoza bør anvendes.
English: In addition to the above studies, Victoza was shown to be effective in reducing adverse cardiovascular (heart and blood vessels) effects.
Danish: Ud over ovennævnte undersøgelser blev det påvist, at Victoza var effektivt til at reducere hjerte-karbivirkninger (kardiovaskulære bivirkninger).
English: Results from this study show that Victoza at a dose of 1.2 mg reduced HbA1c by 0.8 percentage points, whereas Victoza at a dose of 1.8 mg led to reductions of 1.1 percentage points.
Danish: Resultaterne fra denne undersøgelsen viste, at Victoza i en dosis på 1,2 mg reducerede HbA1c med 0,8 procentpoint, mens Victoza i en dosis på 1,8 mg førte til et fald på 1,1 procentpoint.
English: For more information about treatment with Victoza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Victoza, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: When Victoza is added to existing treatment containing metformin or a thiazolidinedione, the doses of these medicines do not have to be changed.
Danish: Når Victoza anvendes som tillægsbehandling til en igangværende behandling med metformin eller et thiazolidindion, skal dosis af disse lægemidler ikke ændres.
English: Combinations containing Victoza were more effective at controlling blood glucose than combinations without the medicine.
Danish: Kombinationer indeholdende Victoza var mere effektive til at regulere blodsukkeret end kombinationer uden lægemidlet.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively.
Danish: Ved type 2-sukkersyge producerer bugspytkirtlen enten ikke nok insulin til at regulere blodsukkeret, eller også er kroppen ikke i stand til at udnytte insulinet effektivt.
English: When Victoza is added to treatment with a sulphonylurea or insulin, the doctor should consider lowering the dose of the other medicine to reduce the risk of having hypoglycaemia (low blood glucose).
Danish: Når Victoza anvendes som tillægsbehandling til en behandling med et sulfonylurinstof eller insulin, bør lægen overveje at sænke dosis af det andet lægemiddel for at reducere risikoen for at få hypoglykæmi (lavt blodsukker).
English: What are the risks associated with Victoza?
Danish: Hvilke risici er der forbundet med Victoza?
English: The active substance in Victoza, liraglutide, is an ‘incretin mimetic'.
Danish: Det aktive stof i Victoza, liraglutid, er et "inkretinmimetikum".
English: The triple therapies containing Victoza led to a reduction of between 1.3 and 1.5 percentage points compared with a reduction equal or less than 0.5 points without Victoza.
Danish: Tripelterapibehandlingerne med Victoza førte til et fald på mellem 1,3 og 1,5 procentpoint sammenlignet med et fald på 0,5 point eller derunder uden Victoza.
English: For the full list of all side effects and restrictions with Victoza, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Victoza fremgår af indlægssedlen.
English: Victoza used on its own was more effective at controlling blood glucose than glimepiride.
Danish: Victoza anvendt alene var mere effektivt til at kontrollere blodsukkeret end glimepirid.
English: This compared with a reduction of 0.5 percentage points with glimepiride.
Danish: Til sammenligning var faldet med glimepirid på 0,5 procentpoint.
English: This helps with the control of blood glucose levels.
Danish: Dette er med til at regulere blodsukkeret.
English: Victoza is a solution for injection available in pre-filled pens (6 mg/ml).
Danish: Victoza fås som injektionsvæske, opløsning, i fyldte penne (6 mg/ml).
English: For practical information about using Victoza, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Victoza, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: In another triple therapy study, Victoza was compared with a single dose of a short-acting insulin, insulin aspart, when added to treatment with basal insulin (a long-acting insulin) plus metformin.
Danish: I en anden "tripelterapi"-undersøgelse blev Victoza sammenlignet med en enkelt dosis af korttidsvirkende insulin, insulin aspart, når det blev tilføjet til behandling med basal insulin (en langtidsvirkende insulin) plus metformin.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Victoza 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 Victoza.
English: Victoza is used:
Danish: Det anvendes:
English: Adding Victoza to treatment with basal insulin plus metformin reduced HbA1c by 0.7 percentage points, compared with 0.4 points when adding Victoza to insulin aspart.
Danish: HbA1c blev reduceret med 0,7 procentpoint, når Victoza blev tilføjet behandling med basal insulin plus metformin, sammenlignet med 0,4 point, når Victoza blev tilføjet til insulin aspart.
English: Dual therapies containing Victoza and metformin or glimepiride led to reductions in HbA1c of around 1 percentage point compared with no reduction without Victoza.
Danish: Dobbeltterapibehandlinger med Victoza og metformin eller glimepirid førte til fald i HbA1c på ca. 1 procentpoint, hvorimod der uden Victoza ikke sås noget fald.
English: The starting dose of Victoza is 0.6 mg. After at least one week, the dose is increased to 1.2 mg.
Danish: Efter mindst en uge øges dosis til 1,2 mg.
English: In two ‘triple therapy' studies, Victoza with metformin and either glimepiride or rosiglitazone (a thiazolidinedione) were compared with treatments that included placebo or another anti-diabetes medicine instead of Victoza.
Danish: I to "tripelterapi"-undersøgelser blev Victoza sammen med metformin og enten glimepirid eller rosiglitazon (et thiazolidindion) sammenlignet med behandlinger, der omfattede placebo eller et andet lægemidler mod sukkersyge i stedet for Victoza.
English: How is Victoza used?
Danish: Hvordan anvendes Victoza?
English: In one ‘monotherapy' study, Victoza on its own was compared with glimepiride (a sulphonylurea).
Danish: I en "monoterapi"-undersøgelse blev Victoza som enkeltmiddelbehandling sammenlignet med glimepirid (et sulfonylurinstof).
English: In two ‘dual therapy' studies, Victoza plus metformin or Victoza plus glimepiride were compared with metformin or glimepiride taken with a placebo (a dummy treatment).
Danish: I to "dobbeltterapi"-undersøgelser blev Victoza plus metformin eller Victoza plus glimepirid sammenlignet med metformin eller glimepirid taget sammen med placebo (en virkningsløs behandling).
English: What benefits of Victoza have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Victoza?
English: How does Victoza work?
Danish: Hvordan virker Victoza?
English: The use of the infusion should be temporary.
Danish: Anvendelse af infusion bør være en midlertidig løsning.
English: The oral solution may be mixed in a glass of water before it is taken.
Danish: Den orale opløsning kan blandes i et glas vand, inden den tages.