FrancophonIA/ELRC3.0 huggingface dataset:
English: The removal of one of the flavours from the formulation had been discussed as a factor that could potentially affect the saliva secretion resulting in an unequal contribution to the local action.
Danish: Fjernelsen af en af smagsvarianterne fra formuleringen er blevet drøftet som en faktor, der potentielt kan have betydning for spytsekretionen og dermed den lokale virkning, der så ikke vil være den samme.
English: The reference medicinal product was Strefen Direct 8,75 mg Oromucosal spray (UK/H/5072/001).
Danish: Referencelægemidlet var Strefen Direct 8,75 mg mundhulespray (UK/H/5072/001).
English: During the decentralised procedure (DCP) and the CMDh procedure, the RMS (ES) considered that the above mentioned differences were minor and without a clinical impact on the efficacy and safety of the test product.
Danish: Under den decentrale procedure og CMDh-proceduren har referencemedlemsstaten (Spanien) vurderet, at ovennævnte forskelle var mindre væsentlige og uden klinisk betydning, hvad angår testproduktets virkning og sikkerhed.
English: Based on the in-vitro tests, equivalence has been shown between the reference and the test products with respect to the following quality attributes: amount of active substance in each dose, the particle size, the plume geometry and the spray pattern.
Danish: Ved brug af in vitro-test er der påvist ækvivalens mellem referencelægemidlet og testproduktet, hvad angår følgende kvalitetsegenskaber: mængde aktivt stof i hver dosis, partikelstørrelse, plumegeometri og spraymønster.
English: Flurbiprofen belongs to the non-steroidal anti-inflammatory class of medicines (NSAID) which have analgesic, antipyretic, and anti-inflammatory properties.
Danish: Flurbiprofen tilhører klassen af non-steroide antiinflammatoriske lægemidler (NSAID'er), der har smertestillende, febernedsættende og antiinflammatoriske egenskaber.
English: The saliva secretion does not play a relevant contribution in the in-vivo performance of the buccal spray since most of the content of the spray is swallowed as a consequence of gag the reflex caused by the impact of the spray in the throat, without any time to be affected by the secretion of saliva.
Danish: Spytsekretionen spiller ingen relevant rolle for mundhulesprayens in vivovirkning, da det meste af indholdet i sprayen sluges som følge af den refleks, som det giver at blive sprayet i halsen; lægemidlet når derfor ikke at blive påvirket af spyttet.
English: In addition, published evidence underline that completely different formulations of flurbiprofen (e.g. lozenge, granules and spray) applied to the oral cavity has demonstrated bioequivalence.
Danish: Derudover viser offentliggjort evidens, at helt forskellige formuleringer af flurbiprofen (f.eks. sugetabletter, granulat og spray), som administreres i mundhulen, har udvist bioækvivalens.
English: The assessment was performed having in mind that this was this is a hybrid application under Article 10(3) of Directive 2001/83/EC.
Danish: Vurderingen er udført under hensyntagen til, at der her er tale om en hybridansøgning i henhold til artikel 10, stk. 3, i direktiv 2001/83/EF.
English: The application for Strefen Direct 8,75 mg Oromucosal spray was made under Article 8(3) of Directive 2001/83/EC.
Danish: Ansøgningen for Strefen Direct 8,75 mg mundhulespray blev indsendt i henhold til artikel 8, stk. 3, i direktiv 2001/83/EF.
English: • The Committee considered the referral under Article 29(4) of Directive 2001/83/EC;
Danish: • Udvalget har behandlet indbringelsen i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF.
English: The application was submitted under Article 10(3) of Directive 2001/83/EC.
Danish: Ansøgningen blev indsendt i henhold til artikel 10, stk. 3, i direktiv 2001/83/EF.
English: Results from the in-vitro tests performed by the applicant have shown equivalence in the critical quality attributes that were tested (single actuation content, droplet size distribution, drug small particles, spray pattern, plum geometry and priming), suggesting that the quantitative and qualitative differences between the reference and the test medicinal products do not affect the deposition of the spray in the site of action (the buccal cavity).
Danish: Resultaterne fra de in vitro-test, som ansøgeren har gennemført, har vist ækvivalens i de kritiske kvalitetsegenskaber, der blev testet (ét aktivt stof, dråbestørrelsefordeling, små lægemiddelpartikler, spraymønster, plume-geometri og priming), hvilket peger på, at de kvantitative og kvalitative forskelle mellem referencelægemidlet og testproduktet ikke har nogen betydning for sprayens aflejring på virkningsstedet (mundhulen).
English: With regards to the different concentration (17.16 mg/ml vs. 16.20 mg/ml), it was noted that that due to the different sprayed volumes (0.17 mL vs. 0.18 mL), the delivered dose is eventually the same.
Danish: Hvad angår koncentrationsforskellen (17,16 mg/ml vs. 16,20 mg/ml), blev det bemærket, at den administrerede dosis i sidste ende er den samme som følge af de forskellige volumener, der sprayes (0,17 ml vs. 0,18 ml).
English: Differences with respect to the reference medicinal product are possible, as long as it is demonstrated that these differences do not affect the therapeutic equivalence between the reference and the test product.
Danish: Forskelle i forhold til referencelægemidlet er mulige, så længe det påvises, at forskellene ikke har betydning for den terapeutiske ækvivalens mellem referencelægemidlet og testproduktet.
English: ii) lower amount of cyclodextrins iii) one flavour less: in the test product one flavour is employed (cherry) instead of two flavours employed in the reference product (cherry and mint)
Danish: ii) lavere mængde cyclodextriner iii) én smagsvariant mindre: I testproduktet anvendes kun én smagsvariant (kirsebær), mens der anvendes to smagsvarianter i referencelægemidlet (kirsebær og mynte).
English: submitted an application under the decentralised procedure for Flurbiprofen Geiser 8,75 mg oromucosal spray, solution and associated names (ES/H/0552/001/DC).
Danish: Ansøgeren, Geiser Pharma S.L., har indsendt en ansøgning under den decentrale procedure for Flurbiprofen Geiser 8,75 mg mundhulespray, opløsning, og relaterede navne (ES/H/0552/001/DC).
English: The test product has some quantitative and qualitative differences with the reference product, namely;
Danish: Der er nogle kvantitative og kvalitative forskelle mellem testproduktet og referencelægemidlet, idet testproduktet har:
English: i) different concentration: 17.16 mg/ml in the test product versus 16.20 mg/ml in the reference product (0.096% difference of content of drug substance in weight/volume)
Danish: i) lavere koncentration: 17,16 mg/ml i referencelægemidlet vs. 16,20 mg/ml i testproduktet (0,096 % vægt/volumen)
English: Differences with respect to the reference medicinal product are possible in the context of a hybrid application, as long as these differences do not affect the therapeutic equivalence between the reference and the test products.
Danish: Forskelle i forhold til referencelægemidlet er mulige i forbindelse med en hybridansøgning, så længe forskellene ikke har betydning for den terapeutiske ækvivalens mellem referencelægemidlet og testproduktet.
English: On the other hand, the waiver of clinical studies supporting equivalent efficacy and safety has been questioned by one of the CMS (NL) because the difference in concentration of the active substance, the qualitative difference in flavours and the quantitative difference in cyclodextrins that in their view could potentially have an impact on the efficacy and the safety of the medicinal product.
Danish: På den anden side har en berørt medlemsstat (Nederlandene) sat spørgsmålstegn ved dispensationen fra at skulle udføre kliniske studier til påvisning af ækvivalent virkning og sikkerhed på grund af forskellen mht. det aktive stofs koncentration, den kvalitative forskel mht. smagsvarianter og den kvantitative forskel mht. cyclodextriner, som efter deres mening potentielt kan have betydning for lægemidlets virkning og sikkerhed.
English: For this application, in order to demonstrate therapeutic equivalence, the applicant has submitted invitro studies.
Danish: I forbindelse med denne ansøgning har ansøgeren fremlagt in vitro-studier for at påvise terapeutisk ækvivalens.
English: Overall summary of the scientific evaluation by the CHMP Flurbiprofen Geiser 8,75 mg oromucosal spray, is a non-steroidal anti-inflammatory (NSAID) with analgesic, antipyretic, and anti-inflammatory properties.
Danish: Flurbiprofen Geiser 8,75 mg mundhulespray er et non-steroidt antiinflammatorisk lægemiddel (NSAID) med smertestillende, febernedsættende og antiinflammatoriske egenskaber.
English: The present referral was triggered on the grounds that the waiver for clinical studies is not in line with the “Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract” (CPMP/EWP/239/95 Rev.1) and that the differences may impact on the clinical performance of the test product.
Danish: Denne indbringelsesprocedure er blevet iværksat, fordi dispensationen fra at skulle gennemføre kliniske studier ikke er i overensstemmelse med retningslinjerne for ækvivalensstudier til påvisning af terapeutisk ækvivalens for lokalt anvendte og lokalt virkende lægemidler i mave-tarm-kanalen ("Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract", CPMP/EWP/239/95 Rev.1), og fordi forskellene kan have betydning for testproduktets kliniske effekt.
English: According to the Guideline on the equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract (CPMP/EWP/239/95 Rev.1) preclinical and clinical trials are considered necessary in order to bridge the test to the reference medicinal product in case the definition of a generic medicinal product is not met.
Danish: Ifølge retningslinjerne for ækvivalensstudier til påvisning af terapeutisk ækvivalens for lokalt anvendte og lokalt virkende lægemidler i mave-tarm-kanalen ("Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract", CPMP/EWP/239/95 Rev.1) vurderes det nødvendigt at gennemføre ikke-kliniske og kliniske studier for at sikre, at testproduktet svarer til referencelægemidlet, hvis definitionen på et generisk lægemiddel ikke er opfyldt.
English: Acknowledging that deviations from the guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract (CPMP/EWP/239/95 Rev.1) could be accepted if they are justified appropriately and having reviewed all the data submitted and the responses submitted by the applicant, the CHMP considered that the waiver of the clinical trials to demonstrate therapeutic equivalence has been adequately substantiated.
Danish: Efter at have gennemgået alle de data og svar, som ansøgeren har fremlagt, og i betragtning af, at afvigelser fra retningslinjerne for ækvivalensstudier til påvisning af terapeutisk ækvivalens for lokalt anvendte og lokalt virkende lægemidler i mave-tarm-kanalen ("Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract", CPMP/EWP/239/95 Rev.1) kan accepteres, hvis de begrundes behørigt, vurderer CHMP, at dispensationen fra at skulle udføre kliniske studier til påvisning af terapeutisk ækvivalens er velunderbygget.
English: ii) the amount of cyclodextrins: the amount of cyclodextrins is lower in the test product compared to this of the reference medicinal product;
Danish: i) koncentrationen: 17,16 mg/ml i referencelægemidlet vs. 16,20 mg/ml i testproduktet ii) mængden af cyclodextriner: Mængden af cyclodextriner er lavere i testproduktet end i referencelægemidlet iii) smagsvarianterne: I testproduktet er der anvendt én smagsvariant (kirsebær) i stedet for to som i referencelægemidlet (kirsebær og mynte)
English: Elderly (≥ 65 years old)
Danish: Ældre (≥ 65 år)
English: See also Serious allergic reactions above.
Danish: Se også Alvorlige allergiske reaktioner ovenfor.
English: ATC code: A10AD01.
Danish: ATC-kode: A10AD01.
English: Every time you use a new pen
Danish: Hver gang du bruger en ny pen
English: Normally this soon disappears.
Danish: Dette forsvinder normalt hurtigt.
English: This will make sure you get the full dose.
Danish: Dette sikrer, at du får den fulde dosis.
English: Date of first authorisation: 07 October 2002 Date of latest renewal: 18 September 2007
Danish: Dato for første markedsføringstilladelse: 07. oktober 2002 Dato for seneste fornyelse: 18. september 2007
English: Before opening: 30 months.
Danish: Før ibrugtagning: 30 måneder.
English: Your medicine might be harmful to their health.
Danish: Din medicin kan være skadelig for deres sundhed.
English: • Get an infection and/or a fever.
Danish: • Får en infektion og/eller feber.
English: You should always measure your blood sugar regularly.
Danish: Du skal altid måle dit blodsukker regelmæssigt.
English: • Eat too little or miss a meal.
Danish: • Spiser for lidt eller springer et måltid over.
English: Careful monitoring is recommended.
Danish: Omhyggelig kontrol anbefales.
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 justering, kan denne finde sted med første dosis eller i løbet af de første få uger eller måneder.
English: The warning signs appear gradually.
Danish: Advarselssignalerne kommer gradvist.
English: Ask your doctor about this.
Danish: Spørg din læge til råds om dette.
English: This is especially important if you take more than one type of insulin.
Danish: Dette er specielt vigtigt, hvis du bruger mere end én type insulin.
English: At the request of the European Medicines Agency;
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur
English: Your InnoLet is designed to work accurately and safely.
Danish: InnoLet er udformet til at fungere præcist og sikkert.
English: • If signs of allergy spread to other parts of your body.
Danish: • Hvis allergisymptomerne spreder sig til andre dele af kroppen.
English: Component of a multipack, cannot be sold separately
Danish: En del af en multipakning, kan ikke sælges enkeltvis
English: How and where to inject
Danish: Hvordan og hvor du skal injicere
English: This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).
Danish: Dette kan udgøre en risiko i situationer, hvor disse evner er af speciel vigtighed (f.eks. ved bilkørsel eller betjening af maskiner).
English: Warning signs of high blood sugar:
Danish: Advarselssignaler på højt blodsukker:
English: • Other medicines for the treatment of diabetes
Danish: • Andre lægemidler til behandling af diabetes
English: Trials have indicated a t½ of about 5-10 hours.
Danish: Forsøg har indikeret en t½ på ca. 5-10 timer.
English: This makes it easier to resuspend.
Danish: Det gør det lettere at opblande.
English: It might lead to cross-infection.
Danish: Det kan føre til krydsinfektion.
English: Actraphane which has been frozen must not be used.
Danish: Actraphane, som har været frosset, må ikke anvendes.
English: Do not refill your FlexPen.
Danish: Genopfyld ikke din FlexPen.
English: • You will hear a click for every single unit dialled.
Danish: • Der høres et klik for hver enhed, der indstilles.
English: ► If it has not been stored correctly or if it has been frozen, see section 5.
Danish: ► Hvis insulinet ikke har været opbevaret korrekt, eller hvis det har været frosset, se punkt 5.
English: Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimesters.
Danish: Insulinbehovet falder normalt i første trimester og stiger efterfølgende i andet og tredje trimester.
English: See Effects from diabetes in section 4.
Danish: Se Følger af diabetes under punkt 4.
English: Reactions usually resolve in a few days to a few weeks.
Danish: Reaktionerne forsvinder sædvanligvis inden for nogle få dage eller uger.
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 arbejde med maskiner:
English: Before every injection:
Danish: Før hver injektion:
English: If you do not respond to glucagon treatment, you will have to be treated in a hospital.
Danish: Hvis du ikke reagerer på glucagonbehandlingen, skal du behandles på hospitalet.
English: Do not use the residual scale, it only shows approximately how much insulin is left in your pen.
Danish: Brug ikke restdosisskalaen, den viser kun cirka hvor meget insulin, der er tilbage i din pen.
English: Name and address of the manufacturers of the biological active substance Novo Nordisk A/S
Danish: Navn og adresse på fremstillerne af det biologisk aktive stof Novo Nordisk A/S
English: Glucose must be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Danish: Glucose skal også gives intravenøst, hvis patienten ikke responderer på glucagon inden for 10 til 15 minutter.
English: This may reduce the risk of developing lumps or skin pitting, see section 4.
Danish: Dette kan nedsætte risikoen for at udvikle hudfortykkelse eller sprækker i huden, se punkt 4.
English: 12 units are marked on the residual scale.
Danish: 12 enheder er markeret på restdosisskalaen.
English: Your FlexPen must be handled with care.
Danish: Din FlexPen skal håndteres forsigtigt.
English: 12 units
Danish: 12 enheder
English: • Drink alcohol, see Actraphane with alcohol in section 2.
Danish: • Drikker alkohol, se Brug af Actraphane sammen med alkohol under punkt 2.
English: The potency of human insulin is expressed in international units.
Danish: Styrken af humant insulin angives i internationale enheder.
English: To avoid injection of air and ensure proper dosing:
Danish: For at undgå injektion af luft og sikre korrekt dosering:
English: You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly).
Danish: Du må aldrig selv injicere direkte i en vene (intravenøst) eller muskel (intramuskulært).
English: The pharmacokinetics of insulin medicinal products are therefore affected by significant intra- and inter-individual variation.
Danish: Insulinpræparaters farmakokinetiske egenskaber påvirkes derfor af betydelige intra- og inter-individuelle variationer.
English: Severe low blood sugar can lead to unconsciousness.
Danish: Alvorligt lavt blodsukker kan føre til bevidstløshed.
English: Further important information
Danish: Anden vigtig information
English: Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar.
Danish: Diabetes er en sygdom, hvor kroppen ikke producerer tilstrækkeligt insulin til at kontrollere blodsukkerniveauet.
English: Do not count the pen clicks.
Danish: Tæl ikke antal penklik.
English: These reactions are usually of a transitory nature.
Danish: Disse bivirkninger er normalt af forbigående karakter.
English: rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Danish: < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra tilgængelige data).
English: Insulin treatment of the nursing mother presents no risk to the baby.
Danish: Insulinbehandling af den ammende moder udgør ikke nogen risiko for barnet.
English: B Before your first injection with a new FlexPen, you must resuspend the insulin:
Danish: B Før din første injektion med en ny FlexPen, er det nødvendigt at opblande insulinet:
English: These reactions can become more severe, or they may change the absorption of your insulin, if you inject in such a site.
Danish: Sådanne reaktioner kan blive mere alvorlige eller måske ændre optagelsen af insulinet, hvis du injicerer på et sådant sted.
English: *Human insulin is produced in Saccharomyces cerevisiae by recombinant DNA technology.
Danish: *Humant insulin er fremstillet i Saccharomyces cerevisiae ved rekombinant DNA-teknologi.
English: Onset of action is within ½ hour, reaches a maximum effect within 2-8 hours and the entire duration of action is up to 24 hours.
Danish: Virkningen indtræder inden for 30 minutter, maksimal virkning opnås 2-8 timer senere, og virkningsvarigheden er højst 24 timer.
English: Actraphane dosing is individual and determined in accordance with the needs of the patient.
Danish: Dosering af Actraphane er individuel og fastsættes i overensstemmelse med patientens behov.
English: This is called acute painful neuropathy and is usually transient.
Danish: Dette kaldes akut smertefuld neuropati og er normalt forbigående.
English: Some conditions and activities can affect your need for insulin.
Danish: Nogle omstændigheder og aktiviteter kan have indflydelse på dit insulinbehov.
English: Insulin in the blood stream has a half-life of a few minutes.
Danish: Insulin i blodet har en halveringstid på nogle få minutter.
English: • Repeatedly inject less insulin than you need.
Danish: • Gentagne gange injicerer mindre insulin, end du har brug for.
English: A number of cleavage (hydrolysis) sites on the human insulin molecule have been proposed; none of the metabolites formed following the cleavage are active.
Danish: Et antal spaltningssteder (hydrolyse) på det humane insulinmolekyle er foreslået; ingen af de metabolitter, der dannes efter spaltningen, er aktive.
English: The manufacturer can be identified by the batch number printed on the slip of the carton and on the label:
Danish: Fremstilleren kan identificeres ved batchnummeret, som er trykt på kartonens slip og på etiketten:
English: This should be kept in mind if treatment with the combination of pioglitazone and Actraphane is considered.
Danish: Dette skal tages i betragtning, hvis kombinationsbehandling med pioglitazon og Actraphane overvejes.
English: Usually, the first symptoms of hyperglycaemia develop gradually over a period of hours or days.
Danish: De første symptomer på hyperglykæmi opstår normalt gradvist over en periode på timer eller dage.
English: • Forget to inject your insulin or stop taking insulin.
Danish: • Glemmer at injicere dit insulin eller stopper med at tage insulin.
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 diabetes, og hvilke konsekvenser det kan have, herunder risikoen for at besvime på grund af lavt blodsukker.
English: The individual insulin requirement is usually between 0.3 and 1.0 international unit/kg/day.
Danish: Det individuelle insulinbehov ligger normalt mellem 0,3-1,0 internationale enheder/kg/dag.
English: How to use Actraphane Dose and when to take your insulin
Danish: Sådan skal du tage Actraphane Dosis og hvornår du skal tage dit insulin
English: The maximum plasma concentration of the fast-acting insulin is reached within 1.5-2.5 hours after subcutaneous administration.
Danish: Maksimal plasmakoncentration for det hurtigtvirkende insulin opnås 1,5-2,5 timer efter subkutan indgivelsesmåde.
English: If not, change the needle and repeat the procedure no more than 6 times.
Danish: Hvis dette ikke sker, skift nålen og gentag proceduren op til 6 gange.
English: Usual warning symptoms may disappear in patients with longstanding diabetes.
Danish: De sædvanlige advarselssymptomer kan udeblive hos patienter med langvarig diabetes.
English: Dispose of it carefully.
Danish: Kassér den omhyggeligt.
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 insulin uden først at tale med din læge, der kan fortælle dig, hvad der skal gøres.
English: Alcohol may intensify or reduce the hypoglycaemic effect of insulin.
Danish: Alkohol kan intensivere eller reducere den hypoglykæmiske effekt af insulin.