FrancophonIA/ELRC3.0 huggingface dataset:
English: Moreover, standard 21/7-day COCs containing LGN 150 µg/ EE 30 µg are widely used and, according to the respective product information in some Member States, the cycle can be extended to 2-months, without HFI.
Danish: Desuden har sædvanlige 21-dages kombinerede orale kontraceptiva indeholdende levonorgestrel 150 µg/ethinylestradiol 30 µg stor udbredelse, og cyklus kan forlænges til 2 måneder uden hormonfri periode i henhold til den pågældende produktinformation i visse medlemsstater.
English: In the pivotal study PSE-301, 3 pregnancies were observed for Seasonique in 1,578 91-day cycles in 621 women aged 18-35 years, resulting in an overall PI of 0.76 with a 95% CI of 0.16 - 2.22 using the Poisson model.
Danish: I hovedundersøgelsen PSE-301 iagttoges tre graviditeter med Seasonique i 1 578 91-dages cyklusser hos 621 kvinder i alderen 18-35 år, svarende til et overordnet Pearl-indeks på 0,76 med 95 % sikkerhedsinterval [0,16; 2,22] ved brug af Poisson-modellen.
English: As expected, due to the extended regimen, the total number of scheduled bleeding/spotting within the planned study duration was 3 times lower for Seasonique than for the comparator (mean 11 vs. 33).
Danish: Som ventet var det samlede antal forventede blødninger/pletblødninger i undersøgelsens planlagte varighed 3 gange lavere for Seasonique end for sammenligningspræparatet (gennemsnitligt 11 mod 33).
English: Based on the results from these published clinical studies Seasonique is expected to have a greater control over ovulation, leading in turn to a higher contraceptive efficacy compared to standard 21/7day LNG/EE COCs and therefore a comparative pharmacodynamic study against standard 21/7-day LNG/EE COCs is not considered mandatory.
Danish: Ud fra disse publicerede kliniske undersøgelser forventes Seasonique at medføre bedre ovulationskontrol og dermed større antikonceptiv virkning end sædvanlige 21/7-dages kombinerede orale kontraceptiva med levonorgestrel/ethinylestradiol.
English: Of note, combined analyses including both arms (DP3-84/30 (higher dose of EE than Seasonique in the last 7 days of the cycle) and DP3-84/10 (Seasonique regimen)) of the pivotal study PSE-301 and the supportive study PSE-302 resulted in a higher PI of 1.67 (95% CI 0.91 - 2.80).
Danish: Det bør bemærkes, at kombinerede analyser af begge arme (DP3-84/30 (højere dosis ethinylestradiol end Seasonique i de sidste 7 dage af cyklus) og DP3-84/10 (Seasonique-regime)) i hovedundersøgelsen PSE-301 og den støttende undersøgelse PSE-302 resulterede i et højere Pearlindeks på 1,67 (95 % SI: [0,91; 2,80]).
English: Further analyses including both arms (DP384/30 (higher dose of EE than Seasonique in the last 7 days of the cycle) and DP3-84/10 (Seasonique)) of the pivotal study PSE-301 and the supportive study PSE-302 did not provide a more reliable estimation of contraceptive efficacy of Seasonique despite the increase in sample size and resulted in a higher PI of 1.67 (95% CI 0.91 - 2.80).
Danish: Yderligere analyser af de to arme i hovedundersøgelsen PSE-301, nemlig DP3-84/30 (højere dosis ethinylestradiol end Seasonique i de sidste 7 dage af cyklussen) og DP3-84/10 (Seasonique), og den støttende undersøgelse PSE-302 gav ikke et mere pålideligt estimat for den antikonceptive virkning af Seasonique trods den større stikprøvestørrelse, men resulterede i et højere Pearl-indeks på 1,67 med 95 % SI [0,91; 2,80].
English: Ovulation occurred in two subjects (5.71% of the women) during the second 28-day period, one whom also ovulated in the third period, resulting in an overall ovarian activity rate of 2.86 (95% CI: 0.78 -7.22) over a period of 91 days.
Danish: Den ene kvinde ovulerede også i den tredje periode, hvilket resulterede i en samlet ovarieaktivitet på 2,86 (95 % SI: [0,78; 7,22]) i en periode på 91 dage.
English: Statistically significantly higher rates of pregnancy with 21/7 and 24/4 regimens compared to the 84/7 regimen (p<0.0001) were also seen in the 2- and 3-year cohorts (Howard, 2014).
Danish: I 2- og 3-års kohorterne sås ligeledes statistisk signifikant højere graviditetsrate med 21/7- og 24/4-regimerne end med 84/7-regimet (p<0,0001) (Howard et al 2014).
English: Comparable withdrawal rates, including discontinuation due to adverse events, were also observed in an open label, randomised phase II study comparing Seasonique (34.5%) to two 28-day OC (35.2% and 39.1%) in 265 women for 8 months.
Danish: Også i en åben, randomiseret fase II-undersøgelse hos 265 kvinder af 8 måneders varighed var udtrædelsesraterne, herunder seponering pga. bivirkninger, den samme for Seasonique (34,5 %) som for to 28-dages orale kontraceptiva (35,2 % og 39,1 %).
English: On the contrary, the total number of unscheduled bleeding/spotting days was twice higher for Seasonique than for the comparator (mean 53 vs. 24).
Danish: Derimod var der i alt dobbelt så mange dage med uventede blødninger/pletblødninger med Seasonique som med sammenligningspræparatet (gennemsnitligt 53 mod 24).
English: With this method, chosen post-hoc, adequate precision with regard to requirements for hormonal contraceptive methods in the CHMP Guideline on Clinical Investigation of steroid contraceptives in women (EMEA/CPMP/EWP/519/98 Rev. 1) would just be reached (depending on the specific bootstrap simulation) with a point estimate of 0.76 and a 95 % CI of (0.0 - 1.76).
Danish: Med denne metode, der blev valgt post hoc, var punktestimatet 0,76 med 95 % sikkerhedsinterval [0,0; 1,76], hvilket netop var tilstrækkelig præcist (afhængigt af den pågældende bootstrap-simulering) til at opfylde kravene til hormonale kontraceptiva i CHMP's retningslinjer for klinisk undersøgelse af steroide antikonceptiva hos kvinder (»Guideline on Clinical Investigation of steroid contraceptives in women« (EMEA/CPMP/EWP/519/98 Rev. 1)).
English: The bleeding pattern of Seasonique was compared to the standard 21/7-day cycle regimen (Nordette, LGN 150 µg/ EE 30 µg and 7-day HFI) in the study PSE 302.
Danish: I undersøgelse PSE 302 blev blødningsmønsteret af Seasonique sammenlignet med et 21/7standardregime (Nordette, levonorgestrel 150 µg/ethinylestradiol 30 µg).
English: Indeed, as in the pivotal study PSE-301 the classic Poisson method failed to reach adequate precision for the 95% CI of the overall Pearl Index (PI) point estimate for Seasonique in women aged 18-35 years (point estimate 0.76, 95% CI of 0.16 - 2.22), the Applicant presented additional analyses using a bootstrap method for calculation of the 95% CI.
Danish: I hovedundersøgelsen PSE-301 resulterede den klassiske Poisson-metode således ikke i et 95 % sikkerhedsinterval med tilstrækkelig præcision af punktestimatet for det overordnede Pearl-indeks for Seasonique hos kvinder mellem 18 og 35 år (punktestimat 0,76, 95 % SI [0,16; 2,22]).
English: ‘Essential' means that the hypertension has no obvious cause.
Danish: "Essentiel" betyder, at hypertensionen ikke har nogen umiddelbar årsag.
English: The European Commission granted a marketing authorisation valid throughout the EU for Dafiro on 16 January 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Dafiro den 16. januar 2007.
English: The full EPAR for Dafiro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Dafiro findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The blood pressure was measured in ‘millimetres of mercury' (mmHg).
Danish: Blodtrykket blev målt i "millimeter kviksølv" (mmHg).
English: Dafiro is taken by mouth as one tablet once a day with some water.
Danish: Dafiro tages oralt som en tablet en gang dagligt med vand.
English: This is a summary of the European public assessment report (EPAR) for Dafiro.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Dafiro.
English: The patient may need to take separate tablets or capsules before switching to the combination tablet.
Danish: Det kan være nødvendigt, at patienten først tager tabletterne eller kapslerne særskilt, inden der skiftes til kombinationstabletten.
English: The medicine can only be obtained with a prescription
Danish: Lægemidlet udleveres kun efter recept.
English: Other information about Dafiro
Danish: Andre oplysninger om Dafiro
English: Dafiro amlodipine / valsartan
Danish: Dafiro amlodipin/valsartan
English: It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells.
Danish: Det blokerer de særlige kanaler på cellernes overflade (calciumkanalerne), hvorigennem calciumioner normalt trænger ind i cellerne.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dafiro.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Dafiro skal anvendes.
English: In all studies, the main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Danish: I samtlige undersøgelser var det vigtigste mål for virkningen reduktionen af det diastoliske blodtryk (blodtrykket målt mellem to hjerteslag).
English: For more information about treatment with Dafiro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Dafiro, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
Danish: Ved at nedsætte blodtrykket mindskes de risici, som er forbundet med forhøjet blodtryk, såsom slagtilfælde.
English: Valsartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Danish: Valsartan er en "angiotensin II-receptorantagonist", hvilket betyder, at det blokerer virkningen af et hormon i kroppen, som kaldes angiotensin II.
English: Both are anti-hypertensive medicines that have been available separately in the European Union (EU) since the mid-1990s.
Danish: Begge er lægemidler mod forhøjet blodtryk, og de har begge hver især været på markedet i Den Europæiske Union (EU) siden midten af
English: The CHMP decided that Dafiro's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Dafiro opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Dafiro.
English: It is available as tablets (5 mg amlodipine and 80 mg valsartan; 5 mg amlodipine and 160 mg valsartan; 10 mg amlodipine and 160 mg valsartan).
Danish: Det fås som tabletter (5 mg amlodipin og 80 mg valsartan, 5 mg amlodipin og 160 mg valsartan, 10 mg amlodipin og 160 mg valsartan).
English: Five main studies involving nearly 5,200 patients, mostly with mild to moderate hypertension, were carried out.
Danish: Der er udført fem hovedundersøgelser, som omfattede næsten 5 200 patienter, der hovedsagelig havde let til moderat forhøjet blodtryk.
English: The fifth, smaller study compared the combination with lisinopril and hydrochlorothiazide (another combination used to treat hypertension) in 130 patients with severe hypertension.
Danish: I den femte, mindre undersøgelse blev kombinationen sammenlignet med lisinopril og hydrochlorothiazid (en anden kombination, som anvendes mod forhøjet blodtryk) hos 130 patienter med svært forhøjet blodtryk.
English: The most common side effects with Dafiro (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), hypokalaemia (low blood potassium levels), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes.
Danish: De hyppigste bivirkninger ved Dafiro (som optræder hos mellem 1 og 10 patienter ud af 100) er hovedpine, betændelse i næse og hals (nasopharyngitis), influenza, lavt kaliumindhold i blodet (hypokaliæmi), forskellige former for hævelser (ødemer), træthed, rødmen, kraftesløshed (asteni) og hedeture.
English: Two studies (involving almost 3,200 patients) compared amlodipine, valsartan or a combination of both substances with placebo (a dummy treatment).
Danish: I to af undersøgelserne (med næsten 3 200 patienter) blev amlodipin, valsartan eller kombinationen af de to stoffer sammenlignet med placebo (en virkningsløs behandling).
English: By blocking the receptors to which angiotensin II normally attaches, valsartan stops the hormone having an effect, allowing the blood vessels to widen.
Danish: Ved at blokere de receptorer, som angiotensin II normalt binder sig til, forhindrer valsartan hormonet i at virke og gør det derved muligt for blodkarrene at udvide sig.
English: What is the risk associated with Dafiro?
Danish: Hvilken risiko er der forbundet med Dafiro?
English: The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Dafiro and people taking the separate medicines.
Danish: Virksomheden fremlagde desuden dokumentation for, at blodets indhold af amlodipin og valsartan er den samme hos personer, der får Dafiro, som hos dem, der får de to lægemidler hver for sig.
English: The combination of amlodipine and valsartan was more effective at reducing blood pressure than placebo or either valsartan or amlodipine taken alone.
Danish: Kombinationen af amlodipin og valsartan var mere effektiv til at sænke blodtrykket end placebo og var mere effektiv end valsartan eller amlodipin anvendt alene.
English: In the studies comparing the combination in patients who were already taking either amlodipine or valsartan, the blood pressure in patients taking valsartan alone had fallen by 6.6 mmHg after eight weeks, compared with 9.6 and 11.4 mmHg in the patients adding 5 or 10 mg amlodipine, respectively.
Danish: I de undersøgelser, hvor kombinationen blev sammenlignet hos patienter, der allerede fik enten amlodipin eller valsartan, var blodtrykket hos de patienter, der fik valsartan alene, faldet med 6,6 mmHg efter otte uger, sammenlignet med henholdsvis 9,6 og 11,4 mmHg hos de patienter, der desuden fik 5 eller 10 mg amlodipin.
English: Dafiro must not be used in patients who have severe liver or bile problems, patients with certain heart problems and patients with severe hypotension (low blood pressure).
Danish: Dafiro må ikke anvendes til patienter med svær lever- eller galdeblæresygdom, patienter med visse hjerteproblemer eller patienter med svær hypotension (lavt blodtryk).
English: The dose of Dafiro to be used depends on the doses of amlodipine or valsartan that the patient was taking before.
Danish: Den dosis af Dafiro, der skal anvendes, afhænger af, hvilken dosis amlodipin eller valsartan patienten fik tidligere.
English: Dafiro must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Danish: Dafiro må heller ikke anvendes i kombination med lægemidler, der indeholder aliskiren (som også anvendes til behandling af essentiel hypertension), hos patienter med type 2-diabetes eller patienter med eller moderat eller svær nyresygdom.
English: For the full list of all side effects reported with Dafiro, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Dafiro fremgår af indlægssedlen.
English: Why has Dafiro been approved?
Danish: Hvorfor blev Dafiro godkendt?
English: Two studies (involving 1,891 patients) compared the combination in patients whose hypertension was not adequately controlled with either 10 mg amlodipine or 160 mg valsartan.
Danish: I to andre undersøgelser (med deltagelse af 1 891 patienter) blev kombinationen sammenlignet hos patienter, hvis forhøjede blodtryk ikke kunne kontrolleres tilfredsstillende med enten 10 mg amlodipin eller 160 mg valsartan.
English: Dafiro must not be used in patients who are hypersensitive (allergic) to amlodipine or other medicines in the ‘dihydropyridine derivatives' class, to valsartan, or to any of the other ingredients.
Danish: Dafiro må ikke anvendes til patienter, der er overfølsomme (allergiske) over for amlodipin eller andre lægemidler i gruppen af "dihydropyridinderivater", valsartan eller andre af indholdsstofferne.
English: When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction.
Danish: Når der kommer calciumioner ind i muskelcellerne i blodkarrenes vægge, trækker karrene sig sammen.
English: Dafiro is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone.
Danish: Dafiro anvendes til patienter med essentiel hypertension (forhøjet blodtryk), når blodtrykket ikke kan kontrolleres tilstrækkeligt med amlodipin eller valsartan alene.
English: Dafiro is a medicine that contains two active substances, amlodipine and valsartan.
Danish: Dafiro er et lægemiddel, der indeholder de to aktive stoffer amlodipin og valsartan.
English: What is Dafiro?
Danish: Hvad er Dafiro?
English: Patients taking amlodipine alone had a fall of 10.0 mmHg, compared with 11.8 mmHg in the patients adding 160 mg valsartan.
Danish: Hos de patienter, der fik amlodipin alene, faldt blodtrykket med 10,0 mmHg sammenlignet med 11,8 mmHg hos dem, der desuden fik 160 mg valsartan.
English: Dafiro contains two active substances, amlodipine and valsartan.
Danish: Dafiro indeholder to aktive stoffer, amlodipin og valsartan.
English: Because amlodipine and valsartan have been used for many years, the company presented information on the two substances from earlier studies and the scientific literature, as well as new studies that used a combination of the two active substances.
Danish: Virksomheden fremlagde derfor oplysninger om de to stoffer fra tidligere undersøgelser og faglitteraturen samt fra nye undersøgelser, hvor der blev anvendt en kombination af de to stoffer.
English: They work in similar ways to reduce blood pressure by allowing the blood vessels to relax.
Danish: Begge stoffer nedsætter blodtrykket ved at virke afslappende på blodkarrene.
English: What is Dafiro used for?
Danish: Hvad anvendes Dafiro til?
English: How has Dafiro been studied?
Danish: Hvordan blev Dafiro undersøgt?
English: What benefit has Dafiro shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Dafiro?
English: By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and this helps the blood vessels to relax.
Danish: Amlodipin mindsker indstrømningen af calcium i cellerne, så de ikke kan trække sig sammen.
English: How is Dafiro used?
Danish: Hvordan anvendes Dafiro?
English: How does Dafiro work?
Danish: Hvordan virker Dafiro?
English: Approximately 25 µg
Danish: 10 μg ca. 25 μg
English: 50 (5 X 10) vials + 50 (5 X 10) pre-filled syringes without needles (multipack)
Danish: 50 (5 x 10) hætteglas + 50 (5x 10) fyldte injektionssprøjter uden kanyler (multipakning)
English: MA (EU) number (Invented)n ame
Danish: MF (EU)-nummer
English: _ _1 After reconstitution, 1 dose (0.5 ml) contains: Diphtheria toxoid, adsorbed
Danish: --1 Efter rekonstitution indeholder 1 dosis (0,5 ml):
English: Conjugate of Haemophilus influenzae type b capsular polysaccharide (PRP)
Danish: Konjugat til Haemophilus influenzae type b kapsulær polysaccharid (PRP) og tetanustoksoid (T), adsorberet (PRP-T)
English: Recombinant hepatitis B surface antigen (S protein), adsorbed
Danish: Rekombinant hepatitis B overfladeantigen (S protein), adsorberet Inaktiveret poliovirus af type 1
English: 10 vials + 10 prefilled syringes without needles
Danish: 10 hætteglas + fyldte injektionssprøjter uden kanyler
English: 1 vial + 1 prefilled syringe without needle
Danish: 1 hætteglas + 1 fyldt injektionssprøjte uden kanyle
English: Pertussis toxoid, adsorbed
Danish: Difteritoksoid, adsorberet Tetanustoksoid, adsorberet Pertussistoksoid, adsorberet Filamentøs hæmagglutinin, adsorberet Pertactin, adsorberet
English: 10 vials + 10 pre-filled syringes + 20 needles
Danish: 10 μg 40 DE 8 DE 32 DE
English: Lavender oil medicines should only be used in adults and children over the age of 12 years.
Danish: Lægemidler med lavendelolie bør kun anvendes hos voksne og børn over 12 år.
English: At the time of the HMPC assessment, there were no major concerns over the safety of lavender oil.
Danish: På tidspunktet for HMPC's vurdering var der ingen alvorlige betænkeligheder ved sikkerheden af lavendelolie.
English: The plant is cultivated or gathered to obtain the oil for medicinal use.
Danish: Planten dyrkes eller høstes for at udvinde olien til medicinsk anvendelse.
English: Patients with open wounds, skin problems, high fever, severe infections and severe heart and circulation problems should not have full baths with lavender oil.
Danish: Patienter med åbne sår, hudproblemer, høj feber, svære infektioner og svære hjerte-karproblemer skal undgå badning af hele kroppen med lavendelolie.
English: Although lavender oil showed a possible effect on anxiety, stress and insomnia, the number of patients per study was too low to establish an effect.
Danish: Skønt lavendelolie viste en mulig virkning på angst, stress og søvnløshed, var antallet af patienter i hver undersøgelse for lavt til, at en virkning kunne fastslås.
English: Lavender oil EMA/HMPC/530968/2012
Danish: Lavendelolie EMA/HMPC/530968/2012
English: Only few and mild side effects had been reported in studies with lavender oil, including very rare cases of allergic reactions.
Danish: Der blev kun beskrevet få og milde bivirkninger i undersøgelserne med lavendelolie, herunder i meget sjældne tilfælde allergiske reaktioner.
English: Lavender oil is the common name for the essential oil of the plant Lavandula angustifolia Mill.
Danish: Lavendelolie er fællesnavnet for den æteriske olie fra planten Lavandula angustifolia Mill.
English: In its assessment, the HMPC also considered studies with lavender oil in patients with different conditions, including anxiety and sleeping disorders.
Danish: Ved sin vurdering gennemgik HMPC desuden undersøgelser med lavendelolie hos patienter med forskellige lidelser, herunder angst og søvnproblemer.
English: Information on the use and licensing of lavender oil medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om anvendelse og godkendelse i EU's medlemsstater af lægemidler, der indeholder lavendelolie, skal indhentes fra de relevante nationale myndigheder.
English: For detailed information on the data assessed by the HMPC, see the HMPC assessment report.
Danish: Nærmere oplysninger om de informationer, HMPC har vurderet, findes i HMPC's vurderingsrapport.
English: Any applications for the licensing of medicines containing lavender oil have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder lavendelolie, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: Other information about lavender oil medicines
Danish: Andre oplysninger om lægemidler, der indeholder lavendelolie