FrancophonIA/ELRC3.0 huggingface dataset:
English: If you stop taking Pramipexole Accord
Danish: Amningen bør ophøre, hvis der gives Pramipexole Accord.
English: Pramipexole Accord 0.7 mg tablets are white to off-white, round, flat faced, bevel edged, with inscription ‘I' and ‘4' on either side of the breakline on one side and breakline on the other side..
Danish: Pramipexole Accord 0,7 mg tabletter er hvide til off-white, runde, flade, med facetslebne kanter og inskriptionen 'I' og '4' på hver side af delekærven på den ene side og med delekærv på den anden side.
English: A sudden stop could cause you to develop a medical condition called neuroleptic malignant syndrome which may represent a major health risk.
Danish: Hvis du har Parkinsons sygdom, bør du ikke stoppe behandlingen med Pramipexole Accord pludseligt, da det kan medføre en sygelig tilstand, der udgør en alvorlig helbredsrisiko (malignt neuroleptika syndrom).
English: What you need to know before you take Pramipexole Accord 3.
Danish: Det skal du vide, før du begynder at tage Pramipexole Accord Sådan skal du tage Pramipexole Accord Bivirkninger
English: In these cases Pramipexole Accord may affect your ability to drive and operate machinery.
Danish: Hvis du tager beroligende medicin og drikker alkohol, kan Pramipexole Accord påvirke din evne til at køre bil og håndtere maskiner.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg pramipexole.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En tablet indeholder 1,0 mg pramipexoldihydrochloridmonohydrat svarende til 0,7 mg pramipexol
English: 2 Pramipexole Accord tablets 0.088 mg three times a day
Danish: 2 tabletter Pramipexole Accord 0,088 mg
English: NAME OF THE MEDICINAL PRODUCT Pramipexole Accord 0.18 mg tablets Pramipexole
Danish: LÆGEMIDLETS NAVN Pramipexole Accord 0,18 mg tabletter pramipexol
English: Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg pramipexole.
Danish: Hver tablet indeholder 1,0 mg pramipexoldihydrochloridmonohydrat svarende til 0.7 mg pramipexole.
English: Parkinson's disease and are also taking levodopa, you might develop dyskinesia during the up titration of Pramipexole Accord.
Danish: • Ufrivillige bevægelser af arme og ben (dyskinesi) Hvis du har Parkinsons sygdom i fremskreden grad og samtidig behandles med levodopa, kan der være risiko for udvikling af ufrivillige bevægelser (dyskinesi), når Pramipexole Accorddosis øges.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg pramipexole.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En tablet indeholder 0,5 mg pramipexoldihydrochloridmonohydrat svarende til 0,35 mg pramipexol
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg pramipexole.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En tablet indeholder 0,25 mg pramipexoldihydrochloridmonohydrat svarende til 0,18 mg pramipexol
English: The tablets are white to off-white, round, flat faced, bevel edged, with inscription ‘I' and ‘5' on either side of the breakline on one side and breakline on other side.
Danish: Tabletterne er hvide til offwhite, runde, flade, med facetslebne kanter og inskriptionen ‘I' og ‘5' på hver side af delekærven på den ene side og delekærv på den anden side.
English: The tablets are white to off-white, round, flat faced, bevel edged, with inscription ‘I' and ‘4' on either side of the breakline on one side and breakline on the other side.
Danish: Tabletterne er hvide til offwhite, runde, flade, med facetslebne kanter og inskriptionen ‘I' og ‘4' på hver side af delekærven på den ene side og delekærv på den anden side.
English: The tablets are white to off-white, round, flat faced, bevel edged, with inscription ‘I' and ‘3' on either side of the breakline on one side and breakline on the other side.
Danish: Tabletterne er hvide til offwhite, runde, flade, med facetslebne kanter og inskriptionen ‘I' og ‘3' på hver side af delekærven på den ene side og delekærv på den anden side.
English: The tablets are white to off-white, round, flat faced, bevel edged, with inscription ‘I' and ‘2' on either side of the breakline on one side and breakline on the other side.
Danish: Tabletterne er hvide til offwhite, runde, flade, med facetslebne kanter og inskriptionen ‘I' og ‘2' på hver side af delekærven på den ene side og delekærv på den anden side.
English: Accord
Danish: Administration
English: When prescribing Pramipexole Accord in a patient with Parkinson's disease with renal impairment a reduced dose is suggested in line with section 4.2.
Danish: Hvis du får Pramipexole Accord til behandling af andre lidelser end Parkinsons sygdom, kan du få følgende bivirkninger:
English: 1 Pramipexole Accord tablet 0.35 mg three times a day OR
Danish: 1 tablet Pramipexole Accord 0,35 mg
English: cadsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (225 micrograms Al).
Danish: 3 Adsorberet på amorf aluminium hydroxyfosfat-sulfat-adjuvans (225 mikrogram Al)
English: 1 dose (0.5 ml) contains approximately: Human Papillomavirusa Type 6 L1 proteinb,c aHuman Papillomavirus = HPV bL1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology.
Danish: 2 L1 protein i form af viruslignende partikler produceret i gærceller (Saccharomyces cerevisiae CANADE 3C-5 (stamme 1895)) ved hjælp af rekombinant DNAteknologi.
English: Package size
Danish: Pakningsstørrelse kanyle
English: 1 pre-filled syringe + 1 needle
Danish: 1 Human papillomavirus = HPV
English: This summary was last updated in 09-2008.
Danish: Dette sammendrag blev sidst ajourført i 09-2008.
English: The marketing authorisation was renewed on 18 September 2003 and on 18 September 2008.
Danish: Markedsføringstilladelsen blev fornyet den 18. september 2003 og den 18. september 2008.
English: There were no differences between the two dose frequencies.
Danish: Der var ingen forskelle mellem de to dosishyppigheder.
English: Other information about Aldara:
Danish: Andre oplysninger om Aldara:
English: It is available as 250 mg sachets, each containing 12.5 mg imiquimod (5%).
Danish: Det fås som breve på 250 mg, som hver indeholder 12,5 mg imiquimod (5 %).
English: This means that it uses the immune system, the body's natural defences, to bring about its effect.
Danish: Det betyder, at det bruger immunsystemet (kroppens naturlige forsvar) til at fremkalde virkningen.
English: The marketing authorisation holder is Meda AB.
Danish: Indehaveren af markedsføringstilladelsen er Meda AB.
English: It is used when other treatments such as cryotherapy (freezing) cannot be used.
Danish: Det bruges, når andre behandlinger som f.eks. kryoterapi (frysning) ikke kan anvendes.
English: In all studies, Aldara was more effective than placebo.
Danish: I alle undersøgelserne var Aldara mere effektivt end placebo.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aldara on 18 September 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Aldara den 18. september 1998.
English: Aldara is used in adults to treat the following skin diseases:
Danish: Aldara anvendes til behandling af voksne med følgende hudsygdomme:
English: The full EPAR for Aldara is available here.
Danish: Den fuldstændige EPAR for Aldara findes her.
English: • small basal cell carcinomas (slow-growing types of skin cancer);
Danish: • små basalcellekarcinomer (en langsomt voksende type hudkræft)
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ALDARA EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) ALDARA EPAR - sammendrag for offentligheden
English: When imiquimod is applied to the skin, it acts locally on the immune system to trigger the release of cytokines, including interferon.
Danish: Når imiquimod påføres på huden, virker det lokalt på immunsystemet for at udløse frigivelse af cytokiner, herunder interferon.
English: In all studies, Aldara was compared with placebo (the same cream but without the active substance).
Danish: I alle undersøgelser blev Aldara sammenlignet med placebo (den samme creme, men uden det aktive stof).
English: • warts on the genitals and around the anus;
Danish: • genitale vorter og vorter omkring anus
English: These substances help to kill the viruses that cause warts or the abnormal cells in the skin that develop into skin cancer or keratoses.
Danish: Disse stoffer hjælper med at slå de vira ihjel, som forårsager vorter, eller de unormale celler i huden, der udvikler sig til hudkræft eller keratoser.
English: The Committee recommended that Aldara be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Aldara.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Aldara's benefits are greater than its risks for the treatment of external genital and perianal warts (condylomata acuminata), small basal cell carcinomas and nonhyperkeratotic, nonhypertrophic actinic keratoses in immunocompetent adult patients when other topical treatment options are contraindicated or less appropriate.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede, at fordelene ved Aldara er større end risiciene til behandling af udvendige genitale og perianale vorter (condylomata acuminata), små basalcellekarcinomer og ikke-hyperkeratotiske, ikke-hypertrofiske aktiniske keratoser hos immunkompetente voksne patienter, når andre topiske behandlingsmuligheder er kontraindiceret eller mindre egnede.
English: Aldara should not be used in people who may be hypersensitive (allergic) to imiquimod or any of the other ingredients.
Danish: Aldara må ikke anvendes til personer, som kan være overfølsomme (allergiske) over for imiquimod eller et eller flere af de øvrige indholdsstoffer.
English: Aldara is a cream containing the active substance imiquimod.
Danish: Aldara er en creme, der indeholder det aktive stof imiquimod.
English: The cream is applied in a thin layer to the affected areas of skin before sleeping, so that it remains on the skin for a suitable length of time (about eight hours) before being washed off. For further information, see the Package Leaflet.
Danish: Der påføres et tyndt lag creme på de angrebne hudområder inden sengetid, så den bliver på huden i et passende tidsrum (ca. otte timer), inden den vaskes af.
English: The most common side effect with Aldara (seen in more that 1 patient in 10) is a reaction at the site of application of the cream (pain or itching).
Danish: Den mest almindelige bivirkning ved Aldara (som optræder hos flere end 1 patient ud af 10) er en reaktion på påføringsstedet (smerte eller kløe).
English: The number of times Aldara is applied and the duration of treatment depend on the condition being treated:
Danish: Påføringshyppigheden og behandlingens varighed afhænger af den tilstand, der behandles:
English: • Aldara has also been studied in 724 patients with small basal cell carcinomas in two studies where patients were treated for six weeks, and used Aldara or placebo either five times a week or every day.
Danish: • Aldara er også blevet undersøgt hos 724 patienter med små basalcellekarcinomer i to undersøgelser, hvor patienterne blev behandlet i seks uger og anvendte Aldara eller placebo enten fem gange om ugen eller hver dag.
English: • Aldara has been studied in 923 patients with genital warts in four main studies lasting 16 weeks.
Danish: • Aldara er blevet undersøgt hos 923 patienter med genitale vorter i fire hovedundersøgelser, der varede 16 uger.
English: • actinic keratoses of the face and scalp (precancerous, abnormal skin growths that develop after too much exposure to sunlight), in patients whose immune system is working normally.
Danish: • aktiniske keratoser i ansigtet og hovedbunden (præcancerøse, unormale hudvækster, der udvikles efter for stor eksponering for sollys) hos patienter, hvis immunsystem fungerer normalt.
English: What is the risk associated with Aldara?
Danish: Hvilken risiko er der forbundet med Aldara?
English: • For small basal cell carcinomas, the cream is applied five times a week for six weeks.
Danish: • Til små basalcellekarcinomer påføres cremen fem gange om ugen i seks uger.
English: The active substance in Aldara cream, imiquimod, is an immune response modifier.
Danish: Det aktive stof i Aldara-cremen, imiquimod, er en immunreaktions-modifikator.
English: • For genital warts, Aldara is applied three times a week for up to 16 weeks.
Danish: • Til genitale vorter påføres Aldara tre gange om ugen i op til 16 uger.
English: • Aldara has also been studied in patients with actinic keratoses in two studies involving a total of 505 patients.
Danish: • Aldara er også blevet undersøgt hos patienter med aktiniske keratoser i to undersøgelser, der i alt omfattede 505 patienter.
English: Why has Aldara been approved?
Danish: Hvorfor blev Aldara godkendt?
English: The main measure of effectiveness was the number of patients with total clearance of the tumours after 12 weeks.
Danish: Det primære mål for virkningen var antallet af patienter, hvor tumorerne var fuldstændig fjernet efter 12 uger.
English: For the full list of all side effects reported with Aldara, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Aldara fremgår af indlægssedlen.
English: What is Aldara?
Danish: Hvad er Aldara?
English: • In the treatment of genital warts, the total clearance rate across the four main studies was 15 to 52% in the Aldara-treated patients, compared with 3 to 18% in the placebo-treated patients.
Danish: • Ved behandlingen af genitale vorter var den samlede fjernelsesprocent i de fire hovedundersøgelser 15 til 52 % hos Aldara-behandlede patienter sammenlignet med 3 til 18 % hos placebobehandlede patienter.
English: The main measure of effectiveness was the number of patients whose keratoses had cleared after one or two four-week courses of treatment.
Danish: Det primære mål for virkningen var antallet af patienter, hvis keratoser var fjernet efter et eller to fireugers behandlingsforløb.
English: • When the results of the two studies in basal cell carcinoma were looked at together, total clearance was seen in 66 to 80% of Aldara-treated patients compared with 0 to 3% in the placebo group.
Danish: • Når resultaterne af de to undersøgelser af basalcellekarcinomer blev sammenholdt, opnåedes der en fuldstændig fjernelse hos 66 til 80 % af de Aldara-behandlede patienter sammenlignet med 0 til 3 % i placebogruppen.
English: • For actinic keratoses, it is applied three times a week, for one or two four-week courses, with four weeks between courses.
Danish: • Til aktiniske keratoser påføres cremen tre gange om ugen i et eller to fireugers behandlingsforløb, hvor der er fire uger mellem forløbene.
English: • In actinic keratoses, complete clearance after one or two courses of treatment was seen in 54 and 55% of Aldara-treated patients in the two studies, compared with 15 and 2% in the placebo-treated patients.
Danish: • Ved aktiniske keratoser opnåedes en fuldstændig fjernelse efter et eller to behandlingsforløb hos 54 og 55 % af Aldara-behandlede patienter i de to undersøgelser sammenlignet med 15 og 2 % hos placebobehandlede patienter.
English: The main measure of effectiveness was the number of patients with total clearance of treated warts.
Danish: Det primære mål for virkningen var antallet af patienter, hvor de behandlede vorter var fuldstændig fjernet.
English: What benefit has Aldara shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Aldara?
English: How has Aldara been studied?
Danish: Hvordan blev Aldara undersøgt?
English: What is Aldara used for?
Danish: Hvad anvendes Aldara til?
English: How is Aldara used?
Danish: Hvordan anvendes Aldara?
English: How does Aldara work?
Danish: Hvordan virker Aldara?
English: The recommended dose is 0.5 mg per kg body weight which the patient should take once.
Danish: Den anbefalede dosis er 0,5 mg/kg legemsvægt, som patienten bør tage én gang.
English: However this risk is considered small as patients take only one dose of the medicine and are supervised by their doctor.
Danish: Denne risiko betragtes dog som lille, da patienterne kun tager en enkelt dosis af lægemidlet og overvåges af deres læge.
English: Overall, the side effects were mostly mild and short-lasting, with no need for a specific treatment.
Danish: Generelt var bivirkningerne for det meste milde og kortvarige og medførte ikke behov for en bestemt behandling.
English: In terms of safety, the main concern was that the medicine may change heart rhythm.
Danish: Med hensyn til sikkerhed var den største bekymring, at lægemidlet kan ændre hjerterytmen.
English: The doctor then takes blood samples 45, 60 and 90 minutes later to see how much growth hormone the body has produced.
Danish: Lægen tager så blodprøver 45, 60 og 90 minutter derefter for at se, hvor meget væksthormon kroppen har produceret.
English: It is not used to treat patients with the condition.
Danish: Det anvendes ikke til behandling af patienter, der har lidelsen.
English: The study involved 166 adults who had either a high, intermediate or low likelihood of having growth hormone deficiency, or who were confirmed not to have growth hormone deficiency.
Danish: Studiet omfattede 166 voksne, som havde enten en høj, mellemliggende eller lav sandsynlighed for at have væksthormonmangel, eller som blev påvist ikke at have væksthormonmangel.
English: It is used by doctors to diagnose growth hormone deficiency, a condition where the patient does not have enough growth hormone.
Danish: Det anvendes af læger til at diagnosticere væksthormonmangel, en tilstand, hvor patienten ikke har nok væksthormon.
English: This means that, although Macimorelin Aeterna Zentaris might not diagnose all cases of disease, it can help to confirm presence of the disease.
Danish: Det betyder, at selv om Macimorelin Aeterna Zentaris ikke kan diagnosticere alle sygdomstilfælde, kan det bidrage til at bekræfte forekomst af sygdommen.
English: Further information on Macimorelin Aeterna Zentaris can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/macimorelin-aeterna-zentaris.
Danish: Yderligere information om Macimorelin Aeterna Zentaris findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/macimorelin-aeterna-zentaris.
English: EMA considered that it is a priority to avoid over-diagnosis of adult growth hormone deficiency and that Macimorelin Aeterna Zentaris helps confirm positive diagnosis and so avoid unnecessary treatment of patients with a false positive test result.
Danish: EMA fandt, at det er en prioritet at undgå at overdiagnosticere væksthormonmangel hos voksne, og at Macimorelin Aeterna Zentaris hjælper med at bekræfte positiv diagnose og dermed undgå unødvendig behandling af patienter med et falsk positivt testresultat.
English: For more information about using Macimorelin Aeterna Zentaris, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Macimorelin Aeterna Zentaris, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Among them, 140 were tested with both Macimorelin Aeterna Zentaris and ITT.
Danish: Blandt dem blev 140 testet med både Macimorelin Aeterna Zentaris og ITT.
English: Side effects reported with Macimorelin Aeterna Zentaris are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Macimorelin Aeterna Zentaris vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: On the whole, Macimorelin Aeterna Zentaris has fewer side effects than the comparator test, which temporarily lowers the level of sugar in the blood.
Danish: Generelt har Macimorelin Aeterna Zentaris færre bivirkninger end sammenligningstesten, som midlertidigt sænker blodsukkerniveauet.
English: The most common side effects with Macimorelin Aeterna Zentaris (which may affect up to 1 in 10 people) are a bitter or metallic taste, tiredness, headache, nausea (feeling sick), dizziness, diarrhoea and feeling hot. Macimorelin Aeterna Zentaris may also cause a change in heart rhythm.
Danish: De hyppigste bivirkninger ved Macimorelin Aeterna Zentaris (som kan forekomme hos op til 1 ud af 10 personer) er en bitter eller metallisk smag, træthed, hovedpine, kvalme, svimmelhed, diarré og generel varmefornemmelse.
English: The level of growth hormone in the blood is then measured and indicates whether or not the body is able to produce growth hormone.
Danish: Væksthormonniveauet i blodet måles derefter for at bestemme, om kroppen er i stand til at producere væksthormon.
English: As for all medicines, data on the use of Macimorelin Aeterna Zentaris are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Macimorelin Aeterna Zentaris løbende overvåget.
English: The active substance in Macimorelin Aeterna Zentaris, macimorelin, stimulates the release of growth hormone into the blood by activating receptors (targets) found on cells in the pituitary gland, a gland located at the base of the brain.
Danish: Det aktive stof i Macimorelin Aeterna Zentaris, macimorelin, stimulerer frigivelsen af væksthormon til blodet ved at aktivere receptorer (mål), der findes på cellerne i hypofysen, en kirtel under hjernen.
English: EMA therefore decided that Macimorelin Aeterna Zentaris's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet konkluderede derfor, at fordelene ved Macimorelin Aeterna Zentaris opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Macimorelin Aeterna Zentaris is available as granules that are dissolved in water and taken by mouth.
Danish: Macimorelin Aeterna Zentaris fås som granulater, der opløses i vand og tages gennem munden.
English: An overview of Macimorelin Aeterna Zentaris and why it is authorised in the EU
Danish: En oversigt over Macimorelin Aeterna Zentaris, og hvorfor det er godkendt i EU
English: Macimorelin Aeterna Zentaris is a medicine used to test the ability of the body to produce growth hormone.
Danish: Macimorelin Aeterna Zentaris er et lægemiddel, der anvendes til at undersøge kroppens evne til at producere væksthormon.
English: Macimorelin Aeterna Zentaris contains the active substance macimorelin.
Danish: Macimorelin Aeterna Zentaris indeholder det aktive stof macimorelin.
English: What measures are being taken to ensure the safe and effective use of Macimorelin Aeterna Zentaris?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Macimorelin Aeterna Zentaris?
English: For the full list of side effects and restrictions with Macimorelin Aeterna Zentaris, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Macimorelin Aeterna Zentaris fremgår af indlægssedlen.
English: Macimorelin Aeterna Zentaris was compared with another test commonly used to diagnose growth hormone deficiency, called insulin tolerance test (ITT), in one main study.
Danish: Macimorelin Aeterna Zentaris blev sammenlignet med en anden test, der almindeligvis anvendes til diagnosticering af væksthormonmangel, den såkaldte insulintolerancetest (ITT), i ét hovedstudie.
English: Macimorelin Aeterna Zentaris can only be obtained with a prescription and its use must be supervised by a healthcare professional experienced in diagnosing growth hormone deficiency.
Danish: Macimorelin Aeterna Zentaris udleveres kun efter recept, og anvendelsen skal overvåges af en sundhedsperson med erfaring i at diagnosticere væksthormonmangel.
English: Overall, 94% of people who tested negative for growth hormone deficiency with ITT also tested negative with Macimorelin Aeterna Zentaris; 74% of people who tested positive with ITT also tested positive with Macimorelin Aeterna Zentaris.
Danish: Generelt sås følgende: 94 % af de personer, der testede negative for væksthormonmangel med ITT, testede også negative med Macimorelin Aeterna Zentaris.