FrancophonIA/ELRC3.0 huggingface dataset:
English: The dissolution is rapid for the outer coating and similar between the test and reference product in various media in the pH range 1 to 6.8 as well as in FeSSIF (Fed state simulated intestinal fluid) and FeSSGF (Fed state simulated gastric fluid).
Danish: Det ydre overtræk opløses hurtigt og på samme måde for testprodukt og referenceprodukt i forskellige medier ved pH mellem 1 og 6.8 og i FeSSIF (simuleret postprandial tarmvæske) og FeSSGF (simuleret postprandial mavesaft).
English: Therefore, it is expected that similar results would be obtained in studies under fed conditions with the lower strengths as it was obtained in the studies under fasting conditions for these strengths.
Danish: Undersøgelser under postprandiale betingelser med de lavere styrker må derfor forventes at ville give resultater svarende til dem, der er opnået i undersøgelserne under fastende betingelser for disse styrker.
English: • For the first phase, the assessment of equivalence should be based on the truncated AUC from t=0 until the cut-off time describing the immediate release dose fraction, and on Cmax during the first phase.
Danish: • For den første fase skal vurderingen af ækvivalens baseres på den trunkerede AUC-værdi fra t=0 til afskæringstidspunktet, der beskriver den hurtigt udløste andel af dosen, og på Cmax i den første fase.
English: Methylphenidate Sandoz which contains the active substance methylphenidate hydrochloride is an osmotic controlled prolonged release film coated tablet with a bi-layer core.
Danish: Methylphenidate Sandoz, der indeholder det aktive stof methylphenidathydrochlorid, er en osmotisk kontrolleret filmovertrukket depottablet med tolaget kerne.
English: They observed that initial methylphenidate profiles were more variable between the subjects in the fed state than in the fasted state.
Danish: Forfatterne iagttog, at de initiale profiler af methylphenidat udviste større variabilitet mellem personerne i postprandial end i fastende tilstand.
English: To support the claim that the high variability seen in the fed study is attributed to physiological conditions after intake of a high fat meal and not differences between the test and reference formulations, a discussion on literature data and the results obtained in the fed study is provided.
Danish: Til støtte for påstanden om, at den iagttagne høje variabilitet i den postprandiale undersøgelse skyldes de fysiologiske betingelser efter indtagelse af et meget fedtholdigt måltid og ikke forskelle mellem testformuleringen og referenceformuleringen, blev der forelagt en gennemgang af litteraturdata og resultaterne af den postprandiale undersøgelse.
English: In addition, the draft guideline on pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1) states that the regulatory criteria applied for biphasic modified release products should follow the criteria applied for the prolonged release phase with additional pharmacokinetic parameters (partial AUC and Cmax).
Danish: Desuden anføres det i udkastet til retningslinjer for farmakokinetisk og klinisk vurdering af formuleringer med modificeret udløsning (EMA/CPMP/EWP/280/96 Corr1), at godkendelseskriterierne for bifasiske produkter med modificeret udløsning følger de kriterier, der finder anvendelse på depotfasen med supplerende farmakokinetiske parametre (partiel AUC og Cmax).
English: The applicant/MAH requests extrapolation of the results from the fed study with 54 mg tablet to the lower strengths.
Danish: Ansøgeren/markedsføringstilladelsesindehaveren anmoder om ekstrapolering af resultaterne fra den postprandiale undersøgelse med 54 mg tabletten til de lavere styrker.
English: • The Committee is of the opinion that bioequivalence was demonstrated under fasting conditions for the immediate and prolonged release phase and under fed conditions for the prolonged release phase.
Danish: • udvalget finder, at der er påvist bioækvivalens under fastende betingelser for den hurtige udløsningsfase og depotfasen samt under postprandiale betingelser for depotfasen,
English: The CHMP is of the opinion that the applicant/MAH provided sufficient evidence to prove that the variability seen in the fed study (0-2 hours) is not related to differences between the test and reference product, but is related to a food-induced effect, which delays the absorption of the active substance from the immediate release layer.
Danish: Det er CHMP's opfattelse, at ansøgeren/indehaveren af markedsføringstilladelsen fremlagde tilstrækkelig evidens for, at den iagttagne variabilitet i den postprandiale undersøgelse (0-2 h) ikke skyldes forskelle mellem testproduktet og referenceproduktet, men en fødefremkaldt effekt, der forsinker absorptionen af det aktive stof fra det hurtigt udløsende lag af produktet.
English: The outer layer of the formulation is dissolved and the highly soluble methylphenidate is released immediately.
Danish: Opløsning af formuleringens ydre lag og udløsning af det letopløselige methylphenidat finder sted øjeblikkeligt.
English: The product is a biphasic modified release formulation, with an immediate release (IR) phase and a prolonged-release (PR) phase.
Danish: Produktet har modificeret bifasisk udløsning fordelt på en hurtig udløsningsfase (IR) og en depotfase (PR) med længerevarende udløsning.
English: The applicant/MAH claimed that the administration of a biphasic methylphenidate modified release formulation with a high fat meal has a major impact on the gastric emptying and transit time, and therefore, can lead to different shapes in the pharmacokinetic profiles in the early absorption phase.
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen hævdede, at ved administration af en bifasisk depotformulering af methylphenidat sammen med et fedtrigt måltid kan tømningen af mavesækken og passagetiden medføre store forskelle i den farmakokinetiske profil i den tidlige absorptionsfase.
English: Consequently, the dissolved drug from the immediaterelease portion of the dosage form only reaches the intestine with delay.
Danish: Det lægemiddel, der opløses fra den hurtigt udløsende del af præparatet, vil derfor først med forsinkelse nå frem til tarmen.
English: In support of the application, the applicant/MAH performed three single dose studies under fasting conditions with the 18, 36 and 54 mg tablets and one single dose study under fed conditions with the 54 mg tablet.
Danish: Til dokumentation for ansøgningen udførte ansøgeren/markedsføringstilladelsesindehaveren tre enkeltdosisundersøgelser under fastende betingelser med 18, 36 og 54 mg tabletterne og en enkeltdosisundersøgelse under postprandiale betingelser med 54 mg tabletten.
English: The PK parameters for the fed study for the immediate release phase were the following: Cmax(0-2h) = 74.8 -142.7 and AUC (0-2h) = 60.0 - 155.6 (90% CI).
Danish: De farmakokinetiske parametre for den postprandiale undersøgelse i den hurtige udløsningsfase var følgende : Cmax(0-2h) = [74,8; 142,7] og AUC (0-2h) = [60,0; 155,6] (90 % SI).
English: The repeat-use MRP marketing authorisation application presented for the medicinal product Methylphenidate Sandoz 18mg, 36mg, 54mg tablets is a generic application in accordance with the Article 10.1 of the Directive 2001/83/EC.
Danish: Ansøgningen efter den gentagne gensidige anerkendelsesprocedure for Methylphenidate Sandoz, tabletter, 18 mg, 36 mg og 54 mg, er en generisk ansøgning i henhold til artikel 10, stk. 1, i direktiv 2001/83/EF.
English: However, the pharmacokinetics (PK) parameters for the immediate release phase (Cmax(0-2h), AUC (0-2h)) for the fed study were not within the conventional criteria of 80%-125%.
Danish: De farmakokinetiske parametre for den hurtige udløsningsfase (Cmax(02h), AUC (0-2h)) i den postprandiale undersøgelse var imidlertid ikke inden for standardkriteriet 80 %125 %.
English: In a post-hoc analysis, the applicant/MAH further provided results for partial metrics (AUC and Cmax) for the immediate release phase and the extended release phase within 0-2 hours and 2-24 hours.
Danish: I en post hoc-analyse fremlagde ansøgeren/markedsføringstilladelsesindehaveren desuden resultater for partielle parametre (AUC og Cmax) for den hurtige udløsningsfase og depotfasen i perioderne 0-2 timer og 2-24 timer.
English: The results showed that bioequivalence was demonstrated for the studies under fasted conditions between Methylphenidate Sandoz (18mg, 36mg, 54mg) and the reference product for the immediate and prolonged release phase.
Danish: Resultaterne viste bioækvivalens for undersøgelserne under fastende betingelser mellem Methylphenidate Sandoz (18 mg, 36 mg, 54 mg) og referenceproduktet i den hurtige udløsningsfase og i depotfasen.
English: • The Committed reviewed all the data submitted by the applicant in order to support the bioequivalence between Methylphenidate Sandoz 18 mg, 36 mg, 54 mg prolonged release tablets and the reference product.
Danish: • udvalget gennemgik alle de af ansøgeren forelagte data til godtgørelse af bioækvivalens mellem Methylphenidate Sandoz, depottabletter, 18 mg, 36 mg og 54 mg, og referenceproduktet,
English: The studies under fed and fasting conditions demonstrated bioequivalence between test and reference product using the entire dose interval (AUC(0-24h) and Cmax(0-24h)).
Danish: Undersøgelserne under postprandiale og fastende betingelser viste bioækvivalens mellem testproduktet og referenceproduktet for hele dosisintervallet (AUC(0-24h) og Cmax(0-24h)).
English: Methylphenidate Sandoz's formulation is designed with an outer coating containing the immediaterelease part surrounding the prolonged-release core (osmotic controlled).
Danish: I formuleringen af Methylphenidate Sandoz anvendes et ydre overtræk, der indeholder den hurtigt udløsende del og omgiver kernen, som udløses ved osmotisk kontrolleret depotvirkning.
English: The additional in vitro dissolution profiles of test and reference product without the immediate release coating demonstrate that a lag time is seen for the prolonged release part and that the active substance in the immediate layer is released fast and independent from the prolonged release part. All in vivo and in vitro results indicate that the prolonged release phase (osmotic controlled) is unaffected by food intake.
Danish: Supplerende in vitro-opløsningsprofiler for testproduktet og referenceproduktet uden det hurtigt udløsende overtræk viser, at der er en forsinkelse for depotdelens vedkommende, og at det aktive stof i det hurtigt udløsende lag udløses hurtigt og uafhængigt af depotdelen.
English: Bioequivalence has been demonstrated for the prolonged release phase (2-24h) for AUC and Cmax under fed and fasting condition.
Danish: Der er påvistbioækvivalens for depotfasen (2-24h) for AUC og Cmax under postprandiale og fastende betingelser.
English: The fed study failed to fulfil the standard acceptance criteria for bioequivalence for the immediate-release phase (AUC (0-2h) and Cmax(0-2h)).
Danish: Undersøgelsen under postprandiale betingelser opfyldte ikke standardkriterierne for bioækvivalens i den hurtige udløsningsfase (AUC(0-2h) og Cmax(0-2h)).
English: the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Methylphenidate Sandoz and associated names (see Annex I).
Danish: • det er udvalgets opfattelse at det er berettiget at undlade undersøgelserne under postprandiale betingelser for de lavere styrker (18 mg og 36 mg), anbefalede CHMP udstedelse af markedsføringstilladelserne, for hvilke produktresuméet, etiketteringen og indlægssedlen er uændrede svarende til endelige version, der er fastlagt ved behandlingen i koordinationsgruppen som anført i bilag III for Methylphenidate Sandoz og relaterede navne (se bilag I).
English: Furthermore, the extrapolation of the fed study conducted with the highest strength 54mg to the lower strengths was not considered acceptable.
Danish: Desuden blev det betragtet som uacceptabelt, at der var ekstrapoleret fra undersøgelsen under postprandiale betingelser med den højeste styrke (54 mg) til de lavere styrker.
English: A clear cut-off between the immediate and extended release fraction as required by the Q&A position paper is not feasible under these conditions.
Danish: Under disse betingelser kan der ikke i praksis opnås en klar afskæring mellem den hurtigt udløsende fraktion og depotfraktionen som krævet i oplægget til spørgsmål og svar.
English: 13 February 2013) for a generic biphasic modified release formulation, equivalence with the reference product needs to be shown for both extent and rate of absorption (reflecting AUC and Cmax for conventional bioequivalence criteria), separately for both the immediate release and extended release phases:
Danish: I henhold til spørgsmål og svar: oplæg vedrørende konkrete spørgsmål stillet til arbejdsgruppen vedrørende farmakokinetik (EMA/618604/2008 Rev. 7, 13. februar 2013) vedrørende en generisk, bifasisk depotformulering skal der påvises ækvivalens med referenceproduktet for både omfanget og hastigheden af absorptionen (som efter sædvanlige bioækvivalenskriterier fremgår af AUC og Cmax), og dette skal ske særskilt for den hurtige udløsningsfase og depotfasen:
English: The bioequivalence under fed conditions has only been studied in the 54 mg strength.
Danish: Undladelse af undersøgelser i postprandial tilstand for styrkerne 18 mg og 36 mg Bioækvivalens under postprandiale betingelser er kun undersøgt for styrken 54 mg.
English: A referral was thus triggered at the CMD(h).
Danish: Der blev derfor foretaget en indbringelse for Koordinationsgruppen Vedrørende Gensidig Anerkendelse og Decentraliserede Godkendelsesprocedurer - human (CMD(h)).
English: Concentration maximal (0-2h) (Cmax(0-2h)), Area Under the Curve(0-2h) (AUC(0-2h)), Cmax(2-24h), AUC (2-24h)) had not been shown between the applied and the reference product.
Danish: Under den gentagne gensidige anerkendelsesprocedure anførte Tyskland og Nederlandene, at der ikke var påvist bioækvivalens under postprandiale betingelser ved anvendelse af de partielle parametre (dvs. maksimal koncentration (0-2h) (Cmax(0-2h)) og areal under kurven (0-2h) (AUC(0-2h)) mellem det ansøgte produkt og referenceproduktet.
English: • At the request of the European Medicines Agency
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur
English: Linearity/non-linearity
Danish: Linearitet/ikke-linearitet
English: Other side effects have been reported:
Danish: Andre bivirkninger er blevet indberettet:
English: de la Industria 30, 28108 Alcobendas, Madrid, Spain.
Danish: de la Industria 30, 28108 Alcobendas, Madrid, Spanien.
English: A risk to the suckling child cannot be excluded.
Danish: En risiko for det ammende barn kan ikke udelukkes.
English: However, it is not possible to definitively determine whether these events are related directly to these risk factors, to CIALIS, to sexual activity, or to a combination of these or other factors.
Danish: Det er imidlertid ikke muligt definitivt at afgøre, hvorvidt hændelserne er direkte relateret til disse risikofaktorer, til CIALIS, til seksuel aktivitet eller til en kombination af disse eller andre faktorer.
English: Talk to your doctor for further information.
Danish: Tal med lægen for yderligere oplysninger.
English: The tablets can be taken with or without food.
Danish: Tabletterne kan tages med eller uden mad.
English: - recently had a stroke within the last 6 months.
Danish: - Har haft et slagtilfælde indenfor de seneste 6 måneder.
English: Patients with diabetes
Danish: Patienter med diabetes
English: An updated RMP shall be submitted every three years.
Danish: Der skal fremsendes en opdateret RMP hvert tredje år.
English: Most of these men had known heart problems before taking this medicine.
Danish: De fleste af disse mænd havde eksisterende hjerteproblemer, før de tog medicinen.
English: These effects were not associated with changes in other parameters such as motility, morphology and FSH.
Danish: Disse følger var ikke associeret med ændringer i andre parametre så som motilitet, morfologi og FSH.
English: This effect lasts at least twelve hours and may be symptomatic, including syncope.
Danish: Effekten varer mindst 12 timer og kan give symptomer, herunder synkope.
English: 4 and 5.2).
Danish: 4.4 og 5.2).
English: The adverse reactions reported were transient, and generally mild or moderate.
Danish: De rapporterede bivirkninger var forbigående og generelt lette eller moderate.
English: Therefore this combination is not recommended (see section 4.4).
Danish: Denne kombination kan derfor ikke anbefales (se pkt.
English: - have low blood pressure or uncontrolled high blood pressure.
Danish: - Har lavt blodtryk eller ukontrolleret højt blodtryk.
English: The patients should be informed not to take CIALIS in such combinations.
Danish: Patienterne skal informeres om ikke at tage Cialis i den slags kombinationer.
English: Date of last renewal: 12 November 2012
Danish: Dato for første markedsføringstilladelse: 12. november 2002 Dato for seneste fornyelse: 12. november 2012
English: The combination of tadalafil and doxazosin is not recommended.
Danish: Kombinationen af tadalafil og doxazosin tilrådes ikke.
English: Children and adolescents CIALIS is not intended for use by children and adolescents under the age of 18.
Danish: Børn og unge CIALIS er ikke beregnet til børn og unge under 18 år.
English: Swallow the tablet whole with some water.
Danish: Synk tabletten hel med et glas vand.
English: In addition, no changes in tadalafil concentrations were seen 3 hours after co-administration with alcohol.
Danish: Ydermere blev der ikke set nogen ændringer i tadalafil koncentrationen 3 timer efter samtidig administration med alkohol.
English: At therapeutic concentrations, 94 % of tadalafil in plasma is bound to proteins.
Danish: Ved terapeutiske koncentrationer er 94% af tadalafil i plasma bundet til proteiner.
English: Most patients reported erectile dysfunction of at least 1 year in duration.
Danish: De fleste patienter rapporterede erektil dysfunktion af mindst 1 års varighed.
English: Take your dose as soon as you remember but do not take a double dose to make up for a forgotten tablet.
Danish: Tag din dosis med det samme, du kommer i tanker om det, men tag ikke en dobbeltdosis som erstatning for den glemte tablet.
English: Symptoms include difficulty in starting to pass water, a feeling of not completely emptying the bladder and a more frequent need to pass water even at night.
Danish: Symptomerne omfatter besvær med at påbegynde vandladning, en følelse af at blæren ikke tømmes helt og hyppigere behov for at lade vandet, også om natten.
English: Adverse events were similar to those seen at lower doses.
Danish: Bivirkningerne var de samme som dem, der ses ved lavere doser.
English: There are limited data from the use of tadalafil in pregnant women.
Danish: Der foreligger begrænsede data for brugen af tadalafil hos gravide kvinder.
English: Do not take CIALIS if you:
Danish: Tag ikke CIALIS, hvis du:
English: CIALIS may still be effective up to 36 hours after taking the tablet.
Danish: CIALIS kan stadig være virksomt op til 36 timer efter, at du har taget tabletten.
English: Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.
Danish: Delvis, midlertidig eller permanent nedsættelse eller tab af synet på det ene eller begge øjne er set sjældent.
English: - a serious liver problem.
Danish: - Alvorlige problemer med din lever.
English: This reduced exposure can be anticipated to decrease the efficacy of tadalafil; the magnitude of decreased efficacy is unknown.
Danish: Denne reducerede eksponering kan forventes at nedsætte effekten af tadalafil; størrelsen af den nedsættende effekt er ukendt.
English: In addition, an updated RMP should be submitted
Danish: Desuden skal der fremsendes en opdateret RMP
English: Take CIALIS with water every day at approximately the same time, either with or without food.
Danish: Tag CIALIS med et glas vand hver dag på omtrent samme tidspunkt, enten med eller uden mad.
English: Antidiabetic medicinal products Specific interaction studies with antidiabetic medicinal products were not conducted.
Danish: Antidiabetika Specifikke interaktionsundersøgelser med antidiabetiske lægemidler er ikke udført.
English: - chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon).
Danish: - Brystsmerter - brug ikke nitrater, men søg straks lægehjælp (hyppighed: Ikke almindelig).
English: Start with the pill from the blister pack that corresponds with the day you start taking CIALIS.
Danish: Start med den tablet fra blisterkortet, der svarer til den dag, du starter med at tage CIALIS.
English: - have serious heart disease or recently had a heart attack within the last 90 days.
Danish: - Har en alvorlig hjertesygdom eller har haft et hjerteanfald indenfor de seneste 90 dage.
English: Alcohol was administered in a manner to maximise the rate of alcohol absorption (overnight fast with no food until 2 hours after alcohol).
Danish: Alkohol blev givet på en måde der maksimerede alkoholabsorptionshastigheden (fastende over natten uden mad indtil 2 timer efter alkoholindtagelse).
English: Although this effect is minor and was of no clinical significance in this study, it should be considered when co-administering these medicinal products.
Danish: Selvom denne effekt er lille og ikke var af klinisk signifikans i denne undersøgelse, bør den tages i betragtning, hvis disse lægemidler administreres samtidigt.
English: There was no evidence of favourable clinical effect of the combination in the population studied.
Danish: Der var ingen evidens for en gunstig klinisk effekt af kombinationen i den undersøgte population.
English: In such circumstances, nitrates should only be administered under close medical supervision with appropriate haemodynamic monitoring.
Danish: Under disse omstændigheder, bør nitrater kun administreres under tæt medicinsk overvågning med passende hæmodynamisk monitorering.
English: Decreased or sudden hearing loss
Danish: Nedsat hørelse eller pludseligt høretab
English: Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors.
Danish: De fleste af de patienter, for hvem disse hændelser blev rapporteret, havde eksisterende kardiovaskulære risikofaktorer.
English: The role of transporters (for example p-glycoprotein) in the disposition of tadalafil is not known.
Danish: Transportproteiners (f.eks. p-glycoprotein) rolle ved fordelingen af tadalafil kendes ikke.
English: (3) More commonly reported when tadalafil is given to patients who are already taking antihypertensive medicinal products.
Danish: (3) Mere almindeligt rapporteret, når tadalafil gives til patienter, som allerede tager antihypertensiva.
English: This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”).
Danish: Dette er medicin (”nitrater”), som bruges til behandling af angina pectoris (”brystsmerter”).
English: These effects are unlikely to lead to a lack of fertility.
Danish: Det er dog usandsynligt, at disse virkninger vil medføre manglende frugtbarhed.
English: Some medicines may be affected by CIALIS or they may affect how well CIALIS will work.
Danish: Visse lægemidler kan blive påvirket af CIALIS, eller de kan påvirke, hvor godt CIALIS virker.
English: Check carefully how you react to the tablets before driving or using machines.
Danish: Hold øje med, hvordan du reagerer på tabletterne, før du begynder at køre bil eller betjene værktøj eller maskiner.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs hele denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: Priapism and anatomical deformation of the penis
Danish: Priapisme og anatomisk deformation af penis
English: The mean volume of distribution is approximately 63 l, indicating that tadalafil is distributed into tissues.
Danish: Det gennemsnitlige fordelingsvolumen er ca. 63 l, hvilket indikerer, at tadalafil fordeles i vævet.