FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Talmanco has been shown to have comparable quality and to be bioequivalent to Adcirca.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Talmanco er af sammenlignelig kvalitet og er bioækvivalent med Adcirca.
English: The active substance in Talmanco, tadalafil, belongs to a group of medicines called ‘phosphodiesterase type 5 (PDE5) inhibitors', which means that it blocks the PDE5 enzyme.
Danish: Det aktive stof i Talmanco, tadalafil, tilhører en gruppe af lægemidler kaldet "phosphodiesterase type 5 (PDE5)-hæmmere", hvilket betyder, at det blokerer PDE5-enzymet.
English: What measures are being taken to ensure the safe and effective use of Talmanco?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Talmanco?
English: Talmanco contains the active substance tadalafil.
Danish: Talmanco indeholder det aktive stof tadalafil.
English: Talmanco is available as 20 mg tablets.
Danish: Talmanco fås som 20-mg-tabletter.
English: What are the benefits and risks of Talmanco?
Danish: Hvilke fordele og risici er der forbundet med Talmanco?
English: Talmanco is a medicine used to treat adults with pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity).
Danish: Talmanco er et lægemiddel til behandling af voksne med pulmonal arteriel hypertension (PAH) med henblik på at forbedre deres fysiske kapacitet (evne til at udføre fysisk aktivitet).
English: Because Talmanco is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Talmanco er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: It is not intended to provide practical advice on how to use Talmanco.
Danish: Det er ikke en praktisk vejledning i, hvordan Talmanco bør anvendes.
English: What is Talmanco and what is it used for?
Danish: Hvad er Talmanco, og hvad anvendes det til?
English: Talmanco can only be obtained with a prescription and treatment should be started and monitored by a doctor who has experience in the treatment of PAH.
Danish: Talmanco udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i at behandle pulmonal arteriel hypertension.
English: When the enzyme is blocked, a substance called ‘cyclic guanosine monophosphate' (cGMP) cannot be broken down and remains in the vessels where it causes widening of the blood vessels.
Danish: Når enzymet blokeres, kan kroppen ikke nedbryde et stof kaldet "cyklisk guanosin monophosphat" (cGMP); stoffet bliver derfor i blodkarrene, hvor det får karrene til at udvide sig.
English: Talmanco is used in patients with class-II (slight limitation of physical activity) or class-III (marked limitation of physical activity) PAH.
Danish: Talmanco anvendes til behandling af patienter med PAH i klasse II (lettere begrænsning af fysisk aktivitet) og klasse III (markant begrænsning af fysisk aktivitet).
English: For more information about treatment with Talmanco, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Talmanco, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This means that Talmanco contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Adcirca.
Danish: Det betyder, at Talmanco er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Adcirca.
English: Why is Talmanco approved?
Danish: Hvorfor blev Talmanco godkendt?
English: Talmanco tadalafil
Danish: tadalafil
English: PAH is abnormally high blood pressure in the arteries of the lungs.
Danish: PAH er unormalt forhøjet blodtryk i lungearterierne.
English: For practical information about using Talmanco, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Talmanco, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: In patients with PAH, this lowers the blood pressure in the lungs and improves symptoms.
Danish: Dette får blodtrykket til at falde i lungerne hos patienter med PAH og forbedrer deres symptomer.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Talmanco 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 Talmanco.
English: How is Talmanco used?
Danish: Hvordan anvendes Talmanco?
English: How has Talmanco been studied?
Danish: Hvordan blev Talmanco undersøgt?
English: How does Talmanco work?
Danish: Hvordan virker Talmanco?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Simbrinza on 18 July 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Simbrinza den 18. juli 2014.
English: This can result in serious vision loss and even blindness.
Danish: Dette kan medføre alvorligt synstab og endda blindhed.
English: This is a summary of the European public assessment report (EPAR) for Simbrinza.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Simbrinza.
English: The full EPAR and risk management plan summary for Simbrinza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Simbrinza findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Simbrinza
Danish: Andre oplysninger om Simbrinza
English: A risk management plan has been developed to ensure that Simbrinza is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Simbrinza anvendes så sikkert som muligt.
English: It will also benefit those patients who need a combination treatment and for whom previously authorised combinations containing the medicine timolol are not suitable.
Danish: Det er også til fordel for patienter, der behøver kombinationsbehandling, og for hvem tidligere godkendte kombinationer indeholdende lægemidlet timolol ikke er egnede.
English: The CHMP therefore concluded that Simbrinza's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: CHMP konkluderede derfor, at fordelene ved Simbrinza opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Simbrinza must not be used in neonates or children under the age of two years and is not recommended in older children.
Danish: Simbrinza må ikke anvendes til nyfødte eller børn under to år, og det frarådes at bruge det hos større børn.
English: Simbrinza brinzolamide / brimonidine tartrate
Danish: Simbrinza brinzolamid/brimonidintartrat
English: Simbrinza was shown to be as effective as the combination treatment.
Danish: Simbrinza blev påvist at være lige så effektivt som den kombinerede behandling.
English: If other eye drops are also being used to lower eye pressure, they should be given at least 5 minutes apart.
Danish: Hvis der samtidig bruges andre øjendråber til at sænke trykket i øjet, skal lægemidlerne gives med mindst fem minutters mellemrum.
English: What is Simbrinza and what is it used for?
Danish: Hvad er Simbrinza, og hvad anvendes det til?
English: What measures are being taken to ensure the safe and effective use of Simbrinza?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Simbrinza?
English: Why is Simbrinza approved?
Danish: Hvorfor er Simbrinza blevet godkendt?
English: Simbrinza can only be obtained by prescription.
Danish: Simbrinza udleveres kun efter recept.
English: As regards safety, the side effects reported with Simbrinza were what would be expected with the individual active substances and raised no major concerns.
Danish: Hvad sikkerheden angår, svarer de indberettede bivirkninger med Simbrinza til, hvad der kan forventes med de enkelte aktive stoffer, og har ikke givet anledning til større betænkeligheder.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Simbrinza, 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 Simbrinza, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: It is not intended to provide practical advice on how to use Simbrinza.
Danish: Det er ikke en praktisk vejledning i, hvordan Simbrinza bør anvendes.
English: The most common side effects in studies with Simbrinza were ocular hyperaemia (red eye) and allergic reactions in the eye, which occurred in about 6 to 7% of patients, and dysgeusia (taste disturbances) in about 3% of patients.
Danish: De hyppigste bivirkninger i undersøgelserne med Simbrinza var røde øjne (okulær hyperæmi) og allergiske reaktioner i øjet, der forekom hos 6-7 % af patienterne, samt smagsforstyrrelser (dysgeusi) hos ca. 3 % af patienterne.
English: The average reduction in intra-ocular pressure with Simbrinza after 3 months was 8.5 mmHg compared with 8.3 mmHg with the combination.
Danish: Den gennemsnitlige mindskelse af trykket i øjet med Simbrinza efter tre måneder var 8,5 mmHg, sammenholdt med 8,3 mmHg med kombinationen.
English: Both medicines have been used separately to reduce eye pressure for several years in the EU and their combination reduces the pressure inside the eye more effectively than either medicine alone.
Danish: Hvert for sig har de to lægemidler været anvendt i flere år i EU til at nedsætte trykket i øjet, og sammen nedsætter de trykket i øjet mere effektivt end hvert for sig.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Simbrinza was shown to be more effective than either active substance used alone and at least as effective as the combination of the active substances given as separate eye drops.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at Simbrinza var påvist at være mere effektivt end hvert aktivt stof anvendt alene og mindst lige så effektivt som de aktive stoffer givet samtidig som separate øjendråber.
English: What are the risks associated with Simbrinza?
Danish: Hvilke risici er der forbundet med Simbrinza?
English: Simbrinza is used when treatment with other medicines containing only one active substance have been tried but has not reduced the intra-ocular pressure sufficiently.
Danish: Simbrinza bruges, når der er forsøgt behandling med andre lægemidler, som kun indeholder ét aktivt stof, uden at det er lykkedes at mindske det intraokulære tryk tilstrækkeligt.
English: Simbrinza must not be used in patients who are hypersensitive (allergic) to the active substances, any of the other ingredients, or to sulphonamides (a class of antibiotics).
Danish: Simbrinza må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for de aktive stoffer, de øvrige indholdsstoffer eller sulfonamider (en klasse antibiotika).
English: For more information about treatment with Simbrinza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Simbrinza, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It must also not be used in patients receiving certain types of antidepressants, patients with severely reduced kidney function, or in patients with hyperchloraemic acidosis (excess acid in the blood caused by too much chloride).
Danish: Det må heller ikke anvendes hos patienter, der får visse typer antidepressiv medicin, eller hos patienter med stærkt nedsat nyrefunktion eller med for højt syreindhold i blodet på grund af for meget klorid (hyperchloræmisk acidose).
English: Simbrinza is an eye drop solution that contains two active substances: brinzolamide and brimonidine tartrate.
Danish: Simbrinza er øjendråber, opløsning, der indeholder to aktive stoffer, nemlig brinzolamid og brimonidintartrat.
English: The active substances in Simbrinza, brinzolamide and brimonidine tartrate, help to reduce intra-ocular pressure by reducing the production of aqueous humour.
Danish: De aktive stoffer i Simbrinza, brinzolamid og brimonidintartrat, nedsætter trykket i øjet ved at mindske produktionen af kammervæske.
English: A second main study involving 890 patients compared Simbrinza with a combination treatment of brinzolamide and brimonidine tartrate given as separate drops.
Danish: I endnu en hovedundersøgelse hos 890 patienter blev Simbrinza sammenlignet med kombineret behandling med brinzolamid og brimonidintartrat givet som separate dråber.
English: The reduction in intra-ocular pressure after 3 months was greater in patients using Simbrinza (an average fall of 7.9 mmHg) than in those using either brinzolamide or brimonidine tartrate (6.5 and 6.4 mmHg, respectively).
Danish: Efter tre måneder var trykket i øjet mindsket mere hos de patienter, der fik Simbrinza (gennemsnitlig mindskelse af trykket på 7,9 mmHg), end hos dem, der enten brugte brinzolamid eller brimonidintartrat alene (henholdsvis 6,5 og 6,4 mmHg).
English: Having the two active substances in one eye drop will improve convenience and adherence to treatment for patients who are not adequately controlled with either brimonidine or brinzolamide alone.
Danish: Øjendråber indeholdende begge aktive stoffer gør overholdelsen af behandlingen lettere for patienter, der ikke kan kontrolleres tilfredsstillende med brimonidin eller brinzolamid alene.
English: For practical information about using Simbrinza, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Simbrinza, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Simbrinza has been shown to be more effective in reducing eye pressure than either brinzolamide or brimonidine tartrate used alone.
Danish: Simbrinza er påvist at være mere effektivt til at nedsætte trykket i øjet end både brinzolamid og brimonidin anvendt hvert for sig.
English: Brimonidine also increases the drainage of aqueous humour from the front of the eye.
Danish: Brimonidin øger desuden bortledningen af kammervæske fra øjets forreste del.
English: For the full list of all side effects reported with Simbrinza, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Simbrinza fremgår af indlægssedlen.
English: Simbrinza is given as one drop into the affected eye(s) twice a day.
Danish: Der gives én dråbe Simbrinza to gange dagligt i det eller de pågældende øjne.
English: What benefits of Simbrinza have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Simbrinza?
English: How does Simbrinza work?
Danish: Hvordan virker Simbrinza?
English: How is Simbrinza used?
Danish: Hvordan anvendes Simbrinza?
English: Simbrinza is used to reduce intra-ocular pressure (pressure inside the eye) in adults with ocular hypertension (high intra-ocular pressure) or in those with an eye condition known as open-angle glaucoma.
Danish: Simbrinza anvendes hos voksne til at nedsætte trykket i øjet (det intraokulære tryk) ved forhøjet tryk i øjet (okulær hypertension) eller ved øjensygdommen åbenvinklet grøn stær.
English: Brinzolamide works by blocking an enzyme called carbonic anhydrase, which produces bicarbonate needed for the production of the aqueous humour, while brimonidine tartrate blocks another enzyme known as adenylate cyclase, which is also involved in the production of the aqueous humour.
Danish: Brinzolamid virker ved at blokere enzymet carboanhydrase, der producerer bikarbonat, som er nødvendigt til dannelse af kammervæske.
English: Open-angle glaucoma (a condition where the aqueous humour, the watery fluid inside the eyeball, cannot drain away properly) and other causes of high pressure in the eye increase the risk of damage to the retina and the optic nerve (the nerve that sends signals from the eye to the brain).
Danish: Lige som andre årsager til højt tryk i øjet medfører dette øget risiko for beskadigelse af nethinden og synsnerven (nerven, der sender signaler fra øjet til hjernen).
English: One main study involved 560 patients with ocular hypertension or open-angle glaucoma, whose average intra-ocular pressure before treatment, measured in units called mmHg, was 26 mmHg.
Danish: Én hovedundersøgelse havde deltagelse af 560 patienter med forhøjet tryk i øjet eller åbenvinklet grøn stær.
English: This summary was last updated in 04-2009.
Danish: Dette sammendrag blev sidst ajourført i 02-2009.
English: Rivastigmine Teva should be given twice a day, with morning and evening meals.
Danish: Rivastigmin Teva skal gives to gange dagligt sammen med morgen- og aftensmåltidet.
English: It is available as capsules (white: 1.5 mg; pink: 3 mg; orange: 4.5 mg; orange and pink: 6 mg).
Danish: Det fås som kapsler (hvide: 1,5 mg, lyserøde: 3 mg, orange: 4,5 mg, orange og lyserøde: 6 mg).
English: The full EPAR for the reference medicine can also be found on the EMEA's website.
Danish: Den fuldstændige EPAR for referencelægemidlet findes også på EMEA's websted.
English: This means that Rivastigmine Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Exelon.
Danish: Det betyder, at Rivastigmin Teva er identisk med et ”referencelægemiddel”, der allerede er godkendt i Den Europæiske Union (EU), og som hedder Exelon.
English: Other information about Rivastigmine Teva:
Danish: Andre oplysninger om Rivastigmin Teva:
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) RIVASTIGMINE TEVA EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) RIVASTIGMIN TEVA EPAR - sammendrag for offentligheden
English: The full EPAR for Rivastigmine Teva can be found here.
Danish: Den fuldstændige EPAR for Rivastigmin Teva findes her.
English: The Committee recommended that Rivastigmine Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Rivastigmin Teva.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Rivastigmine Teva has been shown to have comparable quality and to be bioequivalent to Exelon.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Rivastigmin Teva i overensstemmelse med EU's krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Exelon.
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Rivastigmine Teva by the patient.
Danish: Behandling bør kun iværksættes, hvis patienten har en omsorgsgiver, der regelmæssigt overvåger patientens indtagelse af Rivastigmin Teva.
English: The European Commission granted a marketing authorisation valid throughout the EU for Rivastigmine Teva to Teva Pharma B.V. on 17 April 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rivastigmin Teva til Teva Pharma B.V.
English: Rivastigmine Teva is a ‘generic medicine'.
Danish: Rivastigmin Teva er et ‘generisk lægemiddel'.
English: Rivastigmine Teva 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: Rivastigmin Teva anvendes til behandling af patienter med let til middelsvær Alzheimers sygdom, en fremadskridende hjernesygdom, der gradvis angriber hukommelse, intellektuelle evner og adfærd.
English: Treatment with Rivastigmine Teva 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: Behandling med Rivastigmin Teva bør iværksættes og overvåges af en læge med erfaring i diagnosticering og behandling af Alzheimers sygdom og demens hos patienter med Parkinsons sygdom.
English: Because Rivastigmine Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine (the two medicines produce the same levels of the active substance in the body).
Danish: Da Rivastigmin Teva er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet (dvs. at de to lægemidler producerer samme mængde af det aktive stof i kroppen).
English: What are the benefit and risk of Rivastigmine Teva?
Danish: Hvilken fordel og risiko er der forbundet med Rivastigmin Teva?
English: Rivastigmine Teva is a medicine containing the active substance rivastigmine.
Danish: Rivastigmin Teva er et lægemiddel, der indeholder det aktive stof rivastigmin.
English: Because Rivastigmine Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Danish: Da Rivastigmin Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: The active substance in Rivastigmine Teva, rivastigmine, is an antidementia medicine.
Danish: Det aktive stof i Rivastigmin Teva, rivastigmin, er et middel til behandling af demens.
English: Rivastigmine Teva can also be used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Danish: Rivastigmin Teva kan desuden anvendes til behandling af let til middelsvær demens hos patienter med Parkinsons sygdom.
English: Why has Rivastigmine Teva been approved?
Danish: Hvorfor blev Rivastigmin Teva godkendt?
English: How has Rivastigmine Teva been studied?
Danish: Hvordan blev Rivastigmin Teva undersøgt?
English: What is Rivastigmine Teva?
Danish: Hvad er Rivastigmin Teva?
English: In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a chemical that allows nerve cells to communicate with each other).
Danish: Hos patienter med Alzheimers sygdom eller med demens som følge af Parkinsons sygdom vil visse hjerneceller dø.
English: What is Rivastigmine Teva used for?
Danish: Hvad anvendes Rivastigmin Teva til?
English: Rivastigmine Teva 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: Derved mindskes symptomerne på Alzheimers sygdom og på demens ved Parkinsons sygdom.
English: How is Rivastigmine Teva used?
Danish: Hvordan anvendes Rivastigmin Teva?
English: How does Rivastigmine Teva work?
Danish: Hvordan virker Rivastigmin Teva?
English: The safety profile in these studies was overall comparable to that seen in adults.
Danish: Sikkerhedsprofilen i disse studier var overordnet set sammenlignelig med den, der blev set for voksne.
English: Effects unknown
Danish: Effekt ukendt
English: ATC code: J05AR15
Danish: ATC-kode: J05AR15
English: It is recommended that the INR (International Normalized Ratio) be monitored.
Danish: Monitorering af INR (International Normalized Ratio) anbefales.
English: Your doctor will discuss the potential benefits and risks of taking EVOTAZ to you and your child.
Danish: Din læge vil drøfte de potentielle fordele og risici ved at tage EVOTAZ for dig og dit barn.