FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the Committee is of the opinion that the observed deviation is attributed to variability between subjects and to physiological conditions after intake of a high fat meal and this does not translate into differences in quality between Methylphenidate Hexal and the reference formulations.
Danish: Det er imidlertid udvalgets opfattelse, at den iagttagne afvigelse skyldes interindividuel og fysiologisk betinget variabilitet efter indtagelse af et måltid med højt fedtindhold, og at dette ikke er et udtryk for kvalitetsforskelle mellem Methylphenidate Hexal og referenceformuleringen,
English: Methylphenidate Hexal which contains the active substance methylphenidate hydrochloride is an osmotic controlled prolonged release film coated tablet with a bi-layer core.
Danish: Methylphenidate Hexal, der indeholder det aktive stof methylphenidathydrochlorid, er en osmotisk kontrolleret filmovertrukket depottablet med tolaget kerne.
English: • The Committee is of the opinion that bioequivalence was demonstrated under fasting conditions for the immediate and prolonged release phases 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: • all strengths shows comparable dissolution profiles in various media in the pH range 1 to 6.8,
Danish: • alle styrker har sammenlignelige opløsningsprofiler i forskellige medier med pH mellem 1 og 6,8 i FeSSIF og FeSSGF
English: The repeat-use MRP was closed on day 210, with Germany which did not agree with the conclusions of the RMS's assessment report and which raised a potential serious risk to public health (PSRPH).
Danish: Den gentagne gensidige anerkendelsesprocedure blev afsluttet på dag 210, hvor størstedelen af de berørte medlemsstater tilsluttede sig referencemedlemsstatens vurderingsrapport bortset fra Tyskland og Nederlandene, som rejste betænkelighed ved en potentiel alvorlig risiko for den offentlige sundhed (PSRPH).
English: The repeat-use MRP marketing authorisation application presented for the medicinal product Methylphenidate Hexal 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 Hexal, 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: The results showed that bioequivalence was demonstrated for the studies under fasted conditions between Methylphenidate Hexal (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 Hexal (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 Hexal 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 Hexal, depottabletter, 18 mg, 36 mg og 54 mg, og referenceproduktet,
English: Methylphenidate Hexal's formulation is designed with an outer coating containing the immediaterelease part surrounding the prolonged-release core (osmotic controlled).
Danish: I formuleringen af Methylphenidate Hexal anvendes et ydre overtræk, der indeholder den hurtigt udløsende del og omgiver kernen, som udløses ved osmotisk kontrolleret depotvirkning.
English: The fed study failed to fulfil the standard acceptance criteria for bioequivalence for the immediaterelease 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 Hexal 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 Hexal og relaterede navne (se bilag I).
English: Waiver of studies under fed conditions for the 18 mg and 36 mg strengths The bioequivalence under fed conditions has only been studied in the 54 mg strength.
Danish: Bioækvivalens under postprandiale betingelser er kun undersøgt for styrken 54 mg.
English: • The Committee is of the opinion that the waiver of the studies under fed conditions for the lower strengths (18 mg and 36 mg) is justified.
Danish: Undladelse af undersøgelser i postprandial tilstand for styrkerne 18 mg og 36 mg
English: Panretin should be used for up to 12 weeks.
Danish: Panretin bør anvendes i op til 12 uger.
English: The main measure of effectiveness was the proportion of patients
Danish: Det primære mål for virkning var andelen af patienter, der
English: The marketing authorisation holder is Eisai Ltd.
Danish: Indehaveren af markedsføringstilladelse er Eisai Ltd.
English: who responded to treatment.
Danish: reagerede på behandlingen.
English: Panretin received a marketing authorisation valid throughout the EU on 11 October 2000.
Danish: Panretin fik markedsføringstilladelse med gyldighed i hele EU den 11. oktober 2000.
English: Further information on Panretin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Panretin findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Around 35% and 37% of the patients using Panretin responded to treatment compared with 18% and 7% of the patients using placebo.
Danish: Ca. 35 % og 37 % af de patienter, der anvendte Panretin, reagerede på behandlingen, sammenholdt med 18 % og 7 % af de patienter, der anvendte placebo.
English: • other treatments (radiotherapy or chemotherapy) are not suitable, and
Danish: • når andre behandlinger (strålebehandling eller kemoterapi) ikke er egnede, og
English: Depending on each lesion's response to treatment, the number of applications can be increased to three or four times a day.
Danish: Alt efter den enkelte læsions reaktion på behandlingen kan antallet af påføringer øges til 3-4 gange dagligt.
English: • the lesions have not responded to HIV treatment,
Danish: • når læsionerne ikke har reageret på hiv-behandling,
English: As for all medicines, data on the use of Panretin are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Panretin løbende overvåget.
English: Other information about Panretin
Danish: Andre oplysninger om Panretin
English: It may be used after this period but only on lesions that are responding to treatment.
Danish: Gelen må gerne anvendes ud over denne periode, men kun på læsioner, der reagerer på behandlingen.
English: For more information about using Panretin, see the package leaflet or contact a doctor or pharmacist.
Danish: For mere information om brug af Panretin, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The European Medicines Agency decided that Panretin's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Panretin opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Panretin.
English: An overview of Panretin and why it is authorised in the EU
Danish: En oversigt over Panretin, og hvorfor det er godkendt i EU
English: Side effects reported with Panretin are carefully evaluated and any necessary action taken to protect patients.
Danish: Indberettede bivirkninger ved Panretin vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Panretin must also not be used in women who are pregnant or who are planning a pregnancy, or who are breast-feeding.
Danish: Panretin må heller ikke anvendes hos kvinder, der ammer, er gravide eller planlægger at blive gravide.
English: • the skin is not broken and the lesions are not swollen,
Danish: • når der ikke er gået hul på huden, og læsionerne ikke er hævede,
English: What is Panretin and what is it used for?
Danish: Hvad er Panretin, og hvad anvendes det til?
English: Why is Panretin authorised in the EU?
Danish: Hvorfor blev Panretin godkendt i EU?
English: A patient was considered to have responded to treatment if their lesions reduced in area or flattened by a certain amount depending on the type of lesions.
Danish: En patient ansås for at have reageret på behandlingen, hvis hans/hendes læsioner blev reduceret i et vist omfang (omkreds eller højde alt efter læsionstype).
English: What measures are being taken to ensure the safe use of Panretin?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Panretin?
English: The most common side effects with Panretin (which may affect more than 1 patient in 10) are rash, pruritus (itching), skin disorders (cracking, scabbing, crusting, draining, oozing) and pain (burning, soreness).
Danish: De hyppigste bivirkninger ved Panretin (der kan forekomme hos mere end 1 ud af 10 patienter) er udslæt, kløe og andre hudgener (huden kan revne, danne skorper, væske eller sive) samt smerte (svie, ømhed).
English: Panretin must not be used in people who may be hypersensitive (allergic) to retinoids in general, alitretinoin, or any of the other ingredients.
Danish: Panretin må ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for retinoider generelt, alitretinoin eller et af de øvrige indholdsstoffer.
English: Panretin is used when:
Danish: Panretin anvendes:
English: Panretin was compared with placebo (a dummy treatment) in two 12-week studies involving a total of 402 patients with Kaposi's sarcoma.
Danish: Panretin blev sammenlignet med placebo (et ikke-aktivt stof) i to 12-ugers studier, der omfattede i alt 402 patienter med Kaposis sarkom.
English: Panretin was more effective than placebo at treating Kaposi's sarcoma.
Danish: Panretin var mere effektivt end placebo til behandling af Kaposis sarkom.
English: What are the risks associated with Panretin?
Danish: Hvilke risici er der forbundet med Panretin?
English: Panretin can only be obtained with a prescription and treatment should be started and maintained by a doctor with experience in treating Kaposi's sarcoma.
Danish: Panretin udleveres kun efter recept, og behandlingen bør igangsættes og vedligeholdes af en læge med erfaring i Kaposis sarkom.
English: Panretin is a medicine used to treat the skin lesions seen in AIDS patients with Kaposi's sarcoma (a type of skin cancer).
Danish: Panretin er et lægemiddel til behandling af hudlæsioner hos aids-patienter med Kaposis sarkom (en type hudkræft).
English: Healthy skin around the lesion should be avoided.
Danish: Den sunde hud omkring læsionen bør ikke påføres gel.
English: It must not be used to treat lesions that are close to areas affected by other skin disorders.
Danish: Panretin må ikke anvendes til behandling af læsioner tæt på hudområder, der er ramt af andre lidelser.
English: Panretin is available as a gel to be applied to the skin lesions twice a day, using enough gel to cover each lesion with a generous coating and then leaving it to dry for three to five minutes before covering with clothing.
Danish: Der skal bruges så tilpas meget af gelen, at den enkelte læsion dækkes med et godt lag, der så skal have lov til at tørre i 3-5 minutter, inden det dækkes med tøj.
English: For the full list of all side effects reported with Panretin, see the package leaflet.
Danish: Den fuldstændige liste over alle indberettede bivirkninger ved Panretin fremgår af indlægssedlen.
English: The active substance in Panretin, alitretinoin, is an anticancer agent that belongs to the group ‘retinoids', substances that are derived from vitamin A. The exact way alitretinoin works in Kaposi's sarcoma is unknown.
Danish: Det aktive stof i Panretin, alitretinoin, er et kræftbekæmpende middel, der tilhører gruppen af retinoider, dvs. stoffer, som udvindes af A-vitamin.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Panretin 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 Panretin.
English: How is Panretin used?
Danish: Hvordan anvendes Panretin?
English: • treatment for visceral (internal) Kaposi's sarcoma is not needed.
Danish: • når det ikke er nødvendigt at behandle for Kaposis sarkom i de indre organer.
English: What benefits of Panretin have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Panretin?
English: How does Panretin work?
Danish: Hvordan virker Panretin?
English: Elderly (≥65 years old)
Danish: Ældre (≥ 65 år)
English: ATC code: A10AD05.
Danish: ATC-kode: A10AD05.
English: This is especially important if you take more than one type of insulin.
Danish: Det er især vigtigt, hvis du tager mere end én type insulin.
English: Before opening: 2 years.
Danish: Før ibrugtagning: 2 år.
English: No data are available.
Danish: Der er ingen tilgængelig data.
English: Normally, this soon disappears.
Danish: Dette forsvinder normalt hurtigt.
English: If not, contact your doctor.
Danish: Hvis ikke, kontakt din læge.
English: Dose adjustments can be made once a week until target HbA1c is reached.
Danish: Justeringer af dosis kan foretages en gang om ugen, indtil målet for HbA1c er nået.
English: Intramuscular administration should be avoided.
Danish: Intramuskulær administration skal undgås.
English: If an adjustment is needed, it may occur with the first dose or during the first few weeks or months.
Danish: Hvis der er behov for en justering, kan det vise sig ved den første dosis eller i løbet af de første få uger eller måneder.
English: EXP During use: Use within 4 weeks
Danish: EXP Under brug: Skal bruges inden 4 uger
English: • Repeatedly take less insulin than you need.
Danish: • Gentagne gange tager mindre insulin, end du har brug for.
English: Absorption, distribution and elimination
Danish: Absorption, fordeling og eliminering
English: Date of last renewal: 2 July 2010
Danish: Dato for seneste fornyelse af tilladelse: 2. juli 2010
English: This makes it easier to resuspend.
Danish: Dette gør opblandingen lettere.
English: Then titrate according to individual needs (see the titration guideline in the table above).
Danish: Derefter titreres i forhold til den enkeltes behov (se titreringsvejledningen i tabellen oven over).
English: To avoid injection of air and ensure proper dosing:
Danish: For at undgå injektion af luft og sikre rigtig dosering:
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen 'EXP' er den sidste dag i den nævnte måned.
English: ► Keep the needle under your skin for at least 6 seconds.
Danish: ► Hold nålen under huden i mindst 6 sekunder.
English: ► Do not refill your FlexPen.
Danish: ► Genfyld ikke din FlexPen.
English: Summary of the safety profile
Danish: Opsummering over sikkerhedsprofilen
English: See How and where to inject, below for information.
Danish: Se Hvordan og hvor du skal injicere, nedenfor for yderligere information.
English: If you do not respond to glucagon treatment, you will have to be treated in a hospital.
Danish: Hvis du ikke reagerer på glukagonbehandlingen, skal du behandles på hospitalet.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you
Danish: Læs denne indlægsseddel grundigt, inden du begynder at bruge medicinen, da den indeholder vigtige oplysninger.
English: ► Please ask your doctor whether you can drive a car or operate a machine:
Danish: ► Spørg din læge, om du må køre bil eller betjene maskiner:
English: Tell relevant people that you have diabetes and what the consequences may be, including the risk of passing out (becoming unconscious) due to low blood sugar.
Danish: Fortæl relevante personer, at du har sukkersyge, og hvilke konsekvenser det kan have, herunder risikoen for at besvime (blive bevidstløs) på grund af lavt blodsukker.
English: Reactions usually resolve in a few days to a few weeks.
Danish: Reaktionerne forsvinder normalt inden for nogle få dage eller uger.
English: • If signs of allergy spread to other parts of your body.
Danish: • Hvis nogle af ovennævnte tegn på allergi spreder sig til andre dele af kroppen.
English: Always keep your pen and needles out of sight and reach of others, especially children.
Danish: Opbevar altid pennen og nålene ude af syne og utilgængeligt for andre, især børn.
English: Do not use the residual scale, it only shows approximately how much insulin is left in your pen.
Danish: Du må ikke bruge restdosisskalaen, den viser kun cirka, hvor meget insulin, der er tilbage i pennen.
English: The duration of action is up to 24 hours (Figure 1).
Danish: Virkningsvarigheden er op til 24 timer (figur 1).
English: This may reduce the risk of developing lumps or skin pitting (see section 4, Possible side effects).
Danish: Dette kan nedsætte risikoen for at udvikle hudfortykkelse eller sprækker i huden (se punkt 4, Bivirkninger).
English: Insulin aspart was rapidly absorbed in both age groups, with similar tmax as in adults.
Danish: Insulin aspart blev hurtigt absorberet i begge aldersgrupper med samme tmax som hos voksne.
English: Mechanism of action and pharmacodynamic effects
Danish: Virkningsmekanisme og farmakodynamisk effekt
English: ► If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: ► Hvis du er gravid, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: • Whenever the risk management system is modified, especially as the results of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: • Other medicines for the treatment of diabetes
Danish: • Andre lægemidler til behandling af sukkersyge
English: Never share your pen with other people.
Danish: Du må aldrig dele din pen med andre.
English: These reactions can become more severe, or they may change the absorption of your insulin, if you inject in such a site.
Danish: Disse reaktioner kan blive mere alvorlige, eller måske ændre optagelsen af insulinet, hvis du injicerer på et sådant sted.
English: The dose should not be increased if hypoglycaemia occurred within these days.
Danish: Dosis må ikke øges, hvis der opstår hypoglykæmi i løbet af disse dage.
English: Eat a meal or snack within 10 minutes of the injection to avoid low blood sugar.
Danish: Indtag et måltid eller et mellemmåltid inden for 10 minutter efter injektion for at undgå lavt blodsukker.
English: Modern insulin products are improved versions of human insulin.
Danish: Moderne insulinprodukter er forbedrede versioner af humaninsuliner.
English: This reduces the risk of contamination, infection,
Danish: Dette nedsætter risikoen for urenheder, infektion,
English: Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be done.
Danish: Stop ikke med at tage dit insulin uden først at tale med din læge, der kan fortælle dig, hvad der skal gøres.
English: The duration of action is 14 to 24 hours (Figure 1).
Danish: Virkningsvarigheden er 14 til 24 timer (figur 1).
English: Glucose must be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Danish: Der skal også indgives glucose intravenøst, hvis patienten ikke reagerer på glucagon inden for 10-15 minutter.
English: This should be kept in mind if treatment with the combination of pioglitazone and NovoMix is considered.
Danish: Dette skal tages i betragtning, hvis kombinationsbehandling med pioglitazon og NovoMix overvejes.
English: ► If you are ill, carry on taking your insulin and consult your doctor.
Danish: ► Hvis du bliver syg, fortsæt da med at tage dit insulin og kontakt din læge.
English: Do not soak, wash or lubricate it as it may damage the pen.
Danish: Den må ikke lægges i blød, vaskes eller smøres, da det kan beskadige pennen.
English: It is therefore recommended that the diabetic patient always carries sugar-containing products.
Danish: Diabetespatienter anbefales derfor altid at bære sukkerholdige produkter på sig.
English: Warning signs of high blood sugar:
Danish: Advarselssymptomer på højt blodsukker:
English: In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy.
Danish: Generelt anbefales intensiv blodglucosekontrol og overvågning af gravide kvinder med diabetes under hele graviditeten, og hvis graviditet påtænkes.
English: FlexPen delivers 1-60 units in increments of 1 unit.
Danish: FlexPen leverer 1-60 enheder i trin på 1 enhed.
English: For patients with an HbA1c higher than 8% a dose reduction should be considered.
Danish: Hos patienter med et HbA1c højere end 8% skal en dosisreduktion overvejes.
English: If it is dropped, damaged or crushed, there is a risk of insulin leakage.
Danish: Hvis den tabes, ødelægges eller knuses, er der risiko for insulinlækage.
English: ► Your FlexPen must be handled with care.
Danish: ► Din FlexPen skal håndteres forsigtigt.
English: The lowest of the three previous days' pre-meal blood glucose levels should be used.
Danish: Det laveste niveau fra tre foregående dages blodglucoseniveauer før måltider skal anvendes.
English: Pioglitazone (tablets used for the treatment of type 2 diabetes)
Danish: Pioglitazon (tabletter der bruges til behandling af type 2-diabetes)
English: The maximum effect is exerted between 1 and 4 hours after injection.
Danish: Maksimal virkning opnås 1 til 4 timer efter injektion.
English: After delivery, insulin requirements return rapidly to pre-pregnancy levels.
Danish: Efter nedkomsten vender insulinbehovet hurtigt tilbage til samme niveau som før graviditeten.
English: However, Cmax differed between the age groups, stressing the importance of the individual titration of insulin aspart.
Danish: Cmax differentierede sig dog mellem aldersgrupperne, hvilket understreger vigtigheden af individuel titrering af insulin aspart.
English: Do not change your insulin unless your doctor tells you to.
Danish: Du må ikke ændre dit insulin, medmindre lægen har sagt det.
English: See c) Effects from diabetes in section 4.
Danish: Se c) Følger af sukkersyge, under punkt 4.
English: Do not count the pen clicks.
Danish: Du må ikke tælle antal klik med pennen.
English: You may recover more quickly from unconsciousness with an injection of the hormone glucagon given by someone who knows how to use it.
Danish: Du kan genvinde bevidstheden hurtigere, hvis du får en injektion af hormonet glukagon af en person, der er instrueret i, hvordan det anvendes.