FrancophonIA/ELRC3.0 huggingface dataset:
English: The additional studies showed that including vitamin D3 in the same tablet with alendronic acid could increase vitamin D levels.
Danish: De supplerende undersøgelser viste, at medtagelse af D3-vitamin i samme tablet, som indeholdt alendronsyre, kunne øge D-vitaminniveauerne.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Fosavance, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Fosavance, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The information presented by the company from earlier studies and the published literature showed that the dose of alendronic acid included in Fosavance was the same as the dose needed to prevent bone loss.
Danish: De oplysninger, som virksomheden fremlagde fra tidligere undersøgelser og fra den offentliggjorte faglitteratur, viste, at dosen af alendronsyre i Fosavance svarede til den dosis, der krævedes for at forebygge tab af knoglemasse.
English: Fosavance must not be used in patients who have abnormalities of the oesophagus, who have hypocalcaemia (low blood calcium levels), or who cannot stand or sit upright for at least 30 minutes.
Danish: Fosavance må ikke anvendes til patienter med abnormiteter i spiserøret (øsofagus), patienter med hypocalcæmi (lavt calciumindhold i blodet) eller patienter, som ikke kan stå eller sidde op i mindst 30 minutter.
English: Fosavance alendronic acid and colecalciferol
Danish: Fosavance alendronsyre og colecalciferol
English: To avoid irritation of the oesophagus (the tube that leads from the mouth to the stomach), the patient should not lie down until after their first food of the day, which should be at least 30 minutes after taking the tablet.
Danish: For at undgå irritation af spiserøret (øsofagus) bør patienten undgå at ligge ned inden dagens første måltid, som skal indtages mindst 30 minutter efter tabletten.
English: Fosavance 70 mg/5,600 IU is for use in patients who are not taking vitamin D supplements.
Danish: Fosavance 70 mg/5 600 IE anvendes til patienter, der ikke tager vitamin Dtilskud.
English: for the full list of restrictions, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger fremgår af indlægssedlen.
English: Fosavance (containing either 2,800 or 5,600 IU colecalciferol) is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of low vitamin D levels.
Danish: Fosavance (indeholder enten 2 800 eller 5 600 IE colecalciferol) anvendes til behandling af osteoporose (en sygdom, som gør knoglerne skrøbelige) hos kvinder efter overgangsalderen, som har risiko for lave D-vitaminniveauer.
English: To support the combination of alendronic acid and vitamin D3 in the same tablet, the company also carried out a study in 717 patients with osteoporosis, including 682 women who had been through the menopause, to show Fosavance's ability to increase vitamin D levels.
Danish: Til understøttelse af kombinationen af alendronsyre og D3-vitamin i samme tablet gennemførte virksomheden ligeledes en undersøgelse med 717 patienter med osteoporose, herunder 682 kvinder efter overgangsalderen, for at påvise, at Fosavance er i stand til øge D-vitaminniveauerne.
English: Fosavance reduces the risk of fractures (broken bones) in the spine and the hip.
Danish: Fosavance mindsker risikoen for knoglebrud i rygsøjlen og hoften.
English: Other information about Fosavance:
Danish: Andre oplysninger om Fosavance
English: This study was extended in 652 patients for a further 24 weeks to compare the effects of continuing with Fosavance 70 mg/2,800 IU on its own or adding another 2,800 IU vitamin D3 (equivalent to using Fosavance 70 mg/5,600 IU).
Danish: Denne undersøgelse blev udvidet til at omfatte 652 patienter i yderligere 24 uger med henblik på at sammenligne virkningerne af at fortsætte med Fosavance 70 mg/2 800 IE alene eller ved tilføjelse af 2 800 IE D3-vitamin (svarende til at anvende Fosavance 70 mg/5 600 IE).
English: For the full list of all side effects reported with Fosavance, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Fosavance fremgår af indlægssedlen.
English: What is the risk associated with Fosavance?
Danish: Hvilken risiko er der forbundet med Fosavance?
English: In the extension study, similar numbers of patients taking Fosavance 70 mg/2,800 IU and Fosavance 70 mg/5,600 IU had low vitamin D levels (below 6%), but the patients taking Fosavance 70 mg/5,600 IU had greater increases in vitamin D levels over the 24 weeks of the study.
Danish: I den udvidede undersøgelse havde et tilsvarende antal patienter, som tog Fosavance 70 mg/2 800 IE og Fosavance 70 mg/5 600 IE, lave D-vitaminniveauer (under 6 %), men de patienter, der tog Fosavance 70 mg/5 600 IE, havde en større stigning i D-vitaminniveauerne i løbet af de 24 uger, undersøgelsen varede.
English: After 15 weeks, fewer patients had low vitamin D levels when they took Fosavance 70 mg/2,800 IU (11%) than when they took alendronic acid only (32%).
Danish: Efter 15 uger havde færre patienter lave Dvitaminniveauer, når de fik Fosavance 70 mg/2 800 IE (11 %), end når de kun fik alendronsyre (32 %).
English: Patients received either Fosavance 70 mg/2,800 IU or alendronic acid only once a week.
Danish: Patienterne fik enten Fosavance 70 mg/2 800 IE eller alendronsyre én gang om ugen.
English: Why has Fosavance been approved?
Danish: Hvorfor blev Fosavance godkendt?
English: The most common side effects with Fosavance (seen between 1 and 10 patients in 100) are headache, abdominal pain (stomach ache), dyspepsia (heartburn), constipation, diarrhoea, flatulence (gas),
Danish: De hyppigste bivirkninger ved Fosavance (som ses hos mellem 1 og 10 patienter ud af 100) er hovedpine, mavesmerter, dyspepsi (halsbrand), forstoppelse, diarré, flatulens (luft i maven), øsofagus-ulcus (sår i spiserøret), dysfagi (synkebesvær), udspilet mave, syreregurgitation (sure opstød) samt smerter i knogler, muskler og led.
English: Fosavance is a medicine that contains two active substances: alendronic acid and colecalciferol (vitamin D3).
Danish: Fosavance er et lægemiddel, der indeholder to aktive stoffer: alendronsyre og colecalciferol (D3vitamin).
English: Fosavance contains two active substances: alendronic acid and colecalciferol (vitamin D3).
Danish: Fosavance indeholder to aktive stoffer: alendronsyre og colecalciferol (D3-vitamin).
English: What is Fosavance?
Danish: Hvad er Fosavance?
English: How has Fosavance been studied?
Danish: Hvordan blev Fosavance undersøgt?
English: What is Fosavance used for?
Danish: Hvad anvendes Fosavance til?
English: What benefit has Fosavance shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Fosavance?
English: How is Fosavance used?
Danish: Hvordan anvendes Fosavance?
English: How does Fosavance work?
Danish: Hvordan virker Fosavance?
English: is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription.
Danish: fås som kapsler (25, 50, 75, 100, 150, 200, 225 og 300 mg), og lægemidlet udleveres kun efter recept.
English: the dose should be reduced gradually, over at least a week.
Danish: bør ligeledes ske gradvist i løbet af mindst en uge.
English: is a medicine used to treat adults with the following conditions:
Danish: er et lægemiddel til behandling af voksne med følgende tilstande:
English: Doctors may choose lower doses in patients with kidney problems.
Danish: Læger kan vælge lavere dosis til patienter med nyreproblemer.
English: contains the active substance pregabalin.
Danish: indeholder det aktive stof pregabalin.
English: contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Lyrica.
Danish: indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Lyrica.
English: This reduces the activity of nerve cells in the brain and spinal cord that are involved in pain, epilepsy and anxiety.
Danish: Dette nedsætter aktiviteten i visse nerveceller i hjernen og rygmarven, der er en medvirkende årsag til smerter, epilepsi og angst.
English: The active substance in Pregabalin Zentiva k.s., pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma‑amino butyric acid (GABA), but has very different biological effects.
Danish: Det aktive stof i Pregabalin Zentiva k.s., pregabalin, minder i sin struktur om kroppens egen "neurotransmitter" gamma-aminosmørsyre (GABA), men dets biologiske virkninger er meget anderledes.
English: has been shown to have comparable quality and to be bioequivalent to Lyrica.
Danish: er af sammenlignelig kvalitet og er bioækvivalent med Lyrica.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Lyrica, and do not need to be repeated for Pregabalin Zentiva k.s.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i de godkendte anvendelser med referencelægemidlet, Lyrica, og det er ikke nødvendigt at gentage disse med Pregabalin Zentiva k.s.
English: For more information about treatment with Pregabalin Zentiva k.s., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pregabalin Zentiva k.s., kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Zentiva k.s.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Pregabalin Zentiva k.s.
English: • neuropathic pain (pain due to nerve damage), including peripheral neuropathic pain, such as the pain experienced by patients with herpes zoster (shingles) or nerve disorders caused by diabetes,
Danish: • smerter, der skyldes beskadigelse af nerver (neuropatiske smerter), herunder perifere neuropatiske smerter, såsom smerterne i forbindelse med helvedesild (herpes zoster) eller nerveforstyrrelser som følge af sukkersyge, og smerter fra centralnervesystemet (centrale neuropatiske smerter), såsom smerter efter rygmarvsskader
English: (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;
Danish: • som tillægsbehandling ved epilepsi hos patienter med partielle epileptiske anfald (anfald, der begynder i en bestemt del af hjernen), når anfaldene ikke kan kontrolleres med patientens nuværende behandling
English: As for every medicine, the company provided studies on the quality of Pregabalin Zentiva k.s.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Pregabalin Zentiva k.s.
English: This is a summary of the European public assessment report (EPAR) for Pregabalin Zentiva k.s.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pregabalin Zentiva k.s.
English: For practical information about using Pregabalin Zentiva k.s., patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Pregabalin Zentiva k.s., kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pregabalin Zentiva k.s.
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 Pregabalin Zentiva k.s.
English: What measures are being taken to ensure the safe and effective use of Pregabalin Zentiva k.s.
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pregabalin Zentiva k.s.
English: What are the benefits and risks of Pregabalin Zentiva k.s.
Danish: Hvilken fordel og risiko er der forbundet med Pregabalin Zentiva k.s.
English: The Committee recommended that Pregabalin Zentiva k.s.
Danish: Udvalget anbefalede, at Pregabalin Zentiva k.s.
English: It is not intended to provide practical advice on how to use Pregabalin Zentiva k.s.
Danish: Det er ikke en praktisk vejledning i, hvordan Pregabalin Zentiva k.s.
English: The full EPAR for Pregabalin Zentiva k.s.
Danish: Den fuldstændige EPAR for Pregabalin Zentiva k.s.
English: When stopping treatment with Pregabalin Zentiva k.s.
Danish: Ophør af behandlingen med Pregabalin Zentiva k.s.
English: Other information about Pregabalin Zentiva k.s.
Danish: Andre oplysninger om Pregabalin Zentiva k.s.
English: This means that Pregabalin Zentiva k.s.
Danish: Det betyder, at Pregabalin Zentiva k.s.
English: Why is Pregabalin Zentiva k.s.
Danish: Hvorfor blev Pregabalin Zentiva k.s.
English: How does Pregabalin Zentiva k.s.
Danish: Hvordan blev Pregabalin Zentiva k.s.
English: The full EPAR for Clynav can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Clynav findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: In the future, if the fish are exposed to the virus, the immune system will be able to respond more quickly.
Danish: Hvis fisken efterfølgende eksponeres for virusset, vil immunsystemet reagere hurtigere.
English: Direct contact should be avoided and protective equipment (for example protective gloves) should be worn when handling the medicine.
Danish: Direkte kontakt bør undgås, og der bør bruges beskyttelsesudstyr (f.eks. beskyttelseshandsker) ved håndtering af vaccinen.
English: This is a summary of the European public assessment report (EPAR) for Clynav.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Clynav.
English: Clynav is a DNA vaccine.
Danish: Clynav er en dna-vaccine.
English: Protection lasts approximately three months after vaccination at average water temperature of 12 ±2 °C.
Danish: Beskyttelsen varer ca. tre måneder efter vaccinering ved en gennemsnitlig vandtemperatur på 12 ± 2 °C.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clynav on
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Clynav den
English: The withdrawal period for fish from Atlantic salmon treated with Clynav is ‘zero' days, which means there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for atlanterhavslaks, der behandles med Clynav, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: The immune system recognises these virus proteins as ‘foreign' and makes defences against them.
Danish: Immunsystemet genkender disse virusproteiner som fremmede og forsvarer sig mod dem.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Clynav's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Clynav opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The most common side effects with Clynav (which may affect more than 1 in 10 fish) are short lived changes in swimming behaviour for up to two days, altered pigmentation (colouration) for up to seven days and lack of appetite for up to nine days.
Danish: De hyppigste bivirkninger ved Clynav (som kan optræde hos mere end 1 ud af 10 fisk) er kortvarige ændringer i svømmeadfærd i op til to dage, forandret pigmentering (farvning) i op til syv dage og mangel på appetit i op til ni dage.
English: Needle injuries at the site of injection are common following vaccination and can persist for at least 90 days.
Danish: Kanyleskader ved injektionsstedet er almindelige efter vaccinering og kan vare ved i mindst 90 dage.
English: The vaccine is given to anaesthetised fish as a single injection into epaxial muscle (muscle of the upper half of the fish) in the area to the front and side of the dorsal fin.
Danish: Vaccinen gives til bedøvede fisk som en enkelt injektion i den epaxiale muskel (musklen i den øverste halvdel af fisken) i området foran og ved siden af rygfinnen.
English: The time for protection to develop following vaccination depends on the water temperature: protection starts within 399 degree days, calculated as mean water temperature in °C multiplied by number of days, for example 40 days at a water temperature of 10 °C.
Danish: Tiden til udvikling af beskyttende immunitet afhænger af vandtemperaturen: Beskyttelsen starter inden for 399 graddage beregnet som middelvandtemperatur i °C ganget med antallet af dage, f.eks. 40 dage ved en vandtemperatur på 10 °C.
English: It is not intended to provide practical advice on how to use Clynav.
Danish: Det er ikke en praktisk vejledning i, hvordan Clynav bør anvendes.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences)
Danish: Vacciner virker ved at "lære" immunsystemet (kroppens naturlige forsvar), hvordan det skal forsvare kroppen mod en sygdom.
English: Other information about Clynav:
Danish: Andre oplysninger om Clynav
English: Pancreas disease in Atlantic salmon can lead to impaired daily weight gain, lesions of the heart, pancreas and skeletal muscle as well as death.
Danish: Pankreassygdom hos atlanterhavslaks kan medføre forringet daglig tilvækst, læsioner i hjerte, pankreas og skeletmuskulatur samt død.
English: Six laboratory studies were conducted in fresh water and sea water to show how effective the vaccine was in protecting salmon from disease caused by SPDV.
Danish: Der blev gennemført seks laboratorieundersøgelser i ferskvand og saltvand for at undersøge, hvor effektivt vaccinen beskyttede laks mod sygdom forårsaget af SPDV.
English: In case of accidental needle stick or self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Danish: Ved utilsigtet nålestik eller selvinjektion skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: Why is Clynav approved?
Danish: Hvorfor er Clynav blevet godkendt?
English: Following artificial infection by co-habitation with infected salmon 29 days and 3 months after vaccination, fish vaccinated with Clynav had improved weight gain, reduced heart, pancreas and skeletal muscle lesions and reduced risk of death compared to fish injected with the dummy saline injection.
Danish: Efter kunstig infektion gennem opdræt sammen med inficerede laks i 29 dage og 3 måneder efter vaccinering sås der hos Clynav-vaccinerede fisk en forbedring af vægtforøgelsen, reducerede læsioner i hjerte, pankreas og skeletmuskulatur samt en nedsat dødelighed sammenholdt med fisk, der havde fået en injektion med uvirksomt saltvand.
English: Clynav is a veterinary vaccine used in Atlantic salmon to protect them against pancreas disease caused by salmonid alphavirus subtype 3 (SAV3).
Danish: Clynav er en veterinær vaccine, der anvendes hos atlanterhavslaks for at beskytte dem mod pankreassygdom forårsaget af salmonid alfavirus undertype 3 (SAV3).
English: What are the risks associated with Clynav?
Danish: Hvilke risici er der forbundet med Clynav?
English: What is Clynav and what is it used for?
Danish: Hvad er Clynav, og hvad anvendes det til?
English: Clynav is available as a solution for injection and can only be obtained with a prescription.
Danish: Clynav fås som injektionsvæske, opløsning, og udleveres kun efter recept.
English: Clynav contains as active substance a DNA plasmid (a small piece of DNA) containing the genetic code for making salmon pancreas disease virus proteins.
Danish: Clynav indeholder som aktivt stof et dna-plasmid (et lille stykke dna), der indeholder den genetiske kode til at danne virusproteinerne i forbindelse med pankreassygdom hos laks.
English: A main laboratory model study looked at the signs of pancreas disease in fish given Clynav compared with a dummy saline injection.
Danish: I en hovedundersøgelse (laboratoriemodel) sås der nærmere på tegnene på pankreassygdom hos fisk, der fik Clynav, sammenholdt med fisk, der fik en uvirksom saltvandsindsprøjtning.
English: For the full list of all side effects reported with Clynav, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Clynav fremgår af indlægssedlen.
English: Clynav salmon pancreas disease vaccine (recombinant DNA plasmid)
Danish: Vaccine mod pankreassygdom hos laks (rekombinant dna-plasmid)
English: Clynav contains a DNA plasmid which, once injected into fish, will lead to the production of salmon pancreas disease virus (SPDV) proteins.
Danish: Clynav indeholder et dna-plasmid, der efter injektion i fisken medfører dannelse af SPDV-proteiner (salmon pancreas disease virus).
English: How is Clynav used?
Danish: Hvordan anvendes Clynav?
English: What benefits of Clynav have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Clynav?
English: For more information about treatment with Clynav, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Clynav, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Clynav, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Clynav, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: How does Clynav work?
Danish: Hvordan virker Clynav?
English: Check you have the right volume.
Danish: Kontroller at du har den rigtige mængde.
English: No specific antidote exists.
Danish: Der findes ingen speciel antidot.
English: * see descriptive section below.
Danish: * se beskrivelse nedenfor.
English: At present there exists no experience on possible long-term consequences of this immunosuppression.
Danish: For øjeblikket er der ingen erfaring med mulige langvarige konsekvenser af denne immunsuppression.
English: The following side effects may occur:
Danish: De følgende bivirkninger kan forekomme:
English: This means that the risk that you develop a malignant disease in the future is slightly higher than for healthy people.
Danish: Det betyder, at risikoen for, at De udvikler en ondartet sygdom i fremtiden, er lidt højere end for raske mennesker.
English: 9/l) are observed in about 20% to 30% of all patients.
Danish: 9/l) er iagttaget hos ca. 20% til 30% af alle patienter.
English: Date of first authorisation: 14/04/2004 Date of last renewal: 27/03/2009
Danish: Dato for første markedsføringstilladelse: 14/04/2004 Dato for seneste fornyelse: 27/03/2009
English: Their frequency varies widely, ranging from 2% to 21%.
Danish: Hyppigheden af disse varierer meget, lige fra 2% til 21%.
English: Additional followup and evaluation may be warranted if no alternative diagnosis can be established.
Danish: Yderligere opfølgning og undersøgelser kan være nødvendige, hvis der ikke kan stilles en alternativ diagnose.
English: Unless fatal, indications were that most or all of these effects would be slowly reversible upon cessation of exposure.
Danish: Medmindre de var fatale, var indikationerne, at de fleste eller alle af disse virkninger ville være langsomt reversible efter ophør af eksponering.
English: The fate of the remainder is unknown.
Danish: Den resterende mængdes skæbne kendes ikke.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis det ikke bruges med det samme, er opbevaringstid og betingelser under brug brugerens ansvar.