FrancophonIA/ELRC3.0 huggingface dataset:
English: − Authorised medicinal products and marketing authorisation applications for which no alternative bioequivalence data or a justification was submitted (annex IB).
Danish: − Godkendte lægemidler og ansøgninger om markedsføringstilladelse, for hvilke ingen alternative bioækvivalensdata eller begrundelse blev fremlagt (bilag IB).
English: For a medicinal product with a marketing authorisation or marketing authorisation application under Article 10(1) of Directive 2001/83/EC as amended, bioequivalence is crucial for the conclusion that efficacy and safety are similar to that of the reference product.
Danish: For lægemidler, der allerede er godkendt, eller for hvilke der er ansøgt om godkendelse i henhold til artikel 10, stk. 1, i direktiv 2001/83/EF med ændringer, er bioækvivalens afgørende for konklusionen om, hvorvidt virkning og sikkerhed er identisk med originalpræparatets.
English: Therefore, for products either authorised or seeking a marketing authorisation based on data generated at Semler, bioequivalence is not established and benefit-risk balance cannot be considered positive, as the possibility of safety/tolerability or efficacy issues cannot be excluded.
Danish: For de lægemidler, der enten allerede er godkendt, eller for hvilke der er indsendt ansøgning om godkendelse baseret på data genereret af Semler, er bioækvivalensen derfor ikke dokumenteret, og benefit/risk-forholdet kan ikke anses for at være positivt, da risikoen for problemer med sikkerheden, tolerabiliteten eller virkningen ikke kan udelukkes.
English: If the bioavailability of the generic product is lower than the bioavailability of the reference medicinal product, this may result in a lower than intended exposure to the active substance, leading potentially to a decrease in efficacy, a delay or even a lack of therapeutic effect.
Danish: Hvis det generiske lægemiddels biotilgængelighed er lavere end referencelægemidlets, vil det kunne medføre lavere eksponering for det aktive stof hos patienterne end tilsigtet, hvilket kan føre til ringere virkning og forsinket eller endog manglende terapeutisk virkning.
English: • The CHMP concluded that, for both marketing authorisations and marketing authorisation applications referred to in annex IA, there was alternative data to establish bioequivalence vis-àvis the EU reference medicinal product.
Danish: • Udvalget konkluderede, at der for både de markedsføringstilladelser og de ansøgninger om markedsføringstilladelse, der er anført i bilag IA, var alternative data til at fastslå bioækvivalens med EU-referencelægemidlet.
English: If the bioavailability of the generic product is higher than the bioavailability of the reference medicinal product, this may result in a higher than intended exposure of patients to the active substance, leading potentially to an increase in the incidence or severity of adverse effects.
Danish: Hvis det generiske lægemiddels biotilgængelighed er større end referencelægemidlets, vil det kunne medføre højere eksponering for det aktive stof hos patienterne end tilsigtet, hvilket kan føre til hyppigere eller alvorligere bivirkninger.
English: c. Marketing authorisations for medicinal products for which the bioequivalence vis-à-vis the EU reference medicinal product has been established (annex IA) should be maintained, as the benefit risk balance of these marketing authorisation is considered favourable.
Danish: c. Markedsføringstilladelserne for lægemidler, hvis bioækvivalens med EU-referencelægemidlet er påvist (bilag IA), bør fastholdes, da benefit/risk-forholdet for disse markedsføringstilladelser anses for positivt.
English: Where the bioequivalence is not established, safety and efficacy cannot be extrapolated from the EU reference medicinal product to the generic medicinal product as the bioavailability of the active
Danish: På grund af manglende påvisning af bioækvivalens kan sikkerheden og virkningen således ikke ekstrapoleres fra EU-referencelægemidlet til det generiske lægemiddel, da der kan være forskel på biotilgængeligheden af det aktive stof mellem de to lægemidler.
English: In the absence of the demonstration of bioequivalence vis-à-vis the EU reference medicinal product, the requirements of Article 10 of Directive 2001/83/EC cannot be considered fulfilled, the efficacy and safety of the concerned medicinal products cannot be established, hence the benefit-risk balance cannot be considered positive.
Danish: Som følge af manglende påvisning af bioækvivalens med EU-referencelægemidlet kan kravene i artikel 10 i direktiv 2001/83/EF ikke anses som opfyldte, og de pågældende lægemidlers virkning og sikkerhed kan ikke fastlægges.
English: − Authorised medicinal products and marketing authorisation applications for which alternative bioequivalence data or a justification was submitted but considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product (annex IB);
Danish: − Godkendte lægemidler og ansøgninger om markedsføringstilladelse, for hvilke alternative bioækvivalensdata eller en begrundelse var fremlagt, men hvor CHMP ikke fandt, at disse var fyldestgørende til at fastslå bioækvivalens med EU-referencelægemidlet (bilag IB).
English: For these medicinal products considered critical by EU Member States, the marketing authorisation holders shall submit a bioequivalence study conducted vis-à-vis the EU Reference Medicinal Product within 12 months following Commission Decision.
Danish: For lægemidler, der af medlemsstaterne anses for kritisk nødvendige, skal indehaverne af markedsføringstilladelse forelægge en undersøgelse af bioækvivalens med EU-referencelægemidlet senest 12 måneder efter Kommissionens beslutning.
English: Should during this period the EU Member State(s) consider a medicinal product not critical anymore, the suspension of the concerned marketing authorisation shall apply.
Danish: Hvis medlemsstaten i løbet af denne periode ikke længere anser lægemidlet for kritisk nødvendigt, træder suspenderingen af markedsføringstilladelsen i kraft.
English: b. Marketing authorisation applications for which bioequivalence data or justification were not submitted or considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product (annex IB) do not satisfy the criteria for authorisation, as the particulars supporting the marketing authorisations are incorrect and the benefit-risk balance of these marketing authorisation is considered not favourable pursuant to Article 26 of Directive 2001/83/EC.
Danish: b. Ansøgningerne om markedsføringstilladelser for lægemidler, for hvilke bioækvivalensdata eller en begrundelse ikke er fremlagt eller af CHMP ikke anses som fyldestgørende til at fastslå bioækvivalens med EU-referencelægemidlet (bilag IB), opfylder ikke kriterierne for godkendelse, da oplysningerne til støtte for markedsføringstilladelserne er urigtige, og benefit/risk-forholdet for disse markedsføringstilladelser ikke er positivt i henhold til artikel 26 i direktiv 2001/83/EF.
English: a. Marketing authorisations for medicinal products for which bioequivalence data or justification were not submitted or considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product (annex IB) should be suspended, as the particulars supporting the marketing authorisations are incorrect and the benefit-risk balance of these marketing authorisations is considered not favourable pursuant to Article 116 of Directive 2001/83/EC.
Danish: a. Markedsføringstilladelserne for lægemidler, for hvilke bioækvivalensdata eller en begrundelse ikke er indsendt eller af CHMP ikke anses som fyldestgørende til at fastslå bioækvivalens med EU-referencelægemidlet (bilag IB), bør suspenderes, da oplysningerne til støtte for markedsføringstilladelserne er urigtige, og benefit/risk-forholdet for disse markedsføringstilladelser ikke er positivt i henhold til artikel 116 i direktiv 2001/83/EF.
English: Should during this period the EU Member State(s) consider a medicinal product not critical anymore, the suspension of the concerned marketing authorisation(s) shall apply.
Danish: Hvis medlemsstaterne i løbet af denne periode ikke længere anser lægemidlet for kritisk nødvendigt, træder suspenderingen af den pågældende markedsføringstilladelse i kraft.
English: For marketing authorisation(s) of a medicinal product considered critical, the suspension may be deferred in the relevant EU Member State(s) for a period which shall not exceed twenty-four months from the Commission Decision.
Danish: For lægemidler, der anses for kritisk nødvendige, kan suspenderingen af markedsføringstilladelsen i de pågældende medlemsstater udsættes i en periode på højst 24 måneder efter Kommissionens beslutning.
English: An authorised medicinal product listed in Annex IB may be considered critical by the EU Member State(s) based on the evaluation of the potential unmet medical need, considering the availability of suitable alternative medicinal products in the respective EU Member State(s) and, as appropriate, the nature of the disease to be treated.
Danish: Et godkendt lægemiddel, der er opført i bilag IB, kan anses for kritisk nødvendigt af en medlemsstat på grundlag af en vurdering af det potentielle uopfyldte medicinske behov.
English: Some of these authorised medicinal products may be considered critical by the individual EU Member States on the evaluation of the potential unmet medical need, considering the availability of suitable alternative medicinal products in the respective EU Member State(s) and, as appropriate, the nature of the disease to be treated.
Danish: Der tages herunder hensyn til tilgængeligheden af egnede alternative lægemidler i de pågældende medlemsstater og, i givet fald, karakteren af den behandlede sygdom.
English: However, pharmacovigilance activities may lack the ability to detect a signal with regard to efficacy or safety and tolerability, therefore CHMP is of the opinion that the absence of any pharmacovigilance signal does not offer sufficient reassurance to conclude on a positive benefit-risk balance in the absence of the demonstration of bioequivalence with the EU reference medicinal product.
Danish: Som følge af den manglende påvisning af bioækvivalens med EU-referencelægemidlet, og da lægemiddelovervågningsaktiviteter ikke altid kan afsløre et problem med hensyn til virkning, sikkerhed eller tolerabilitet, er CHMP af den opfattelse, at det faktum, at lægemiddelovervågningen ikke har afsløret nogen problemer, ikke giver tilstrækkelig sikkerhed til at konkludere, at benefit/risk-forholdet er positivt.
English: * This p value is not considered statistically significant.
Danish: * Denne p-værdi anses ikke for statistisk signifikant.
English: Can't be sold separately.
Danish: Må ikke sælges separat.
English: The individual components of the endpoint are also shown.
Danish: Endepunktets individuelle komponenter er også vist.
English: You may need a lower dose.
Danish: De har måske brug for en lavere dosis.
English: It is important that you take CHAMPIX regularly at the same time each day.
Danish: Det er vigtigt, at De tager CHAMPIX regelmæssigt på samme tidspunkt hver dag.
English: You should write this date on the pack as a reminder.
Danish: De skal skrive denne dato på pakningen som en påmindelse.
English: An updated RMP should be submitted:
Danish: En opdateret RMP fremsendes:
English: Linearity/Non linearity
Danish: Lineraritet/non-linearitet
English: Absorption is virtually complete after oral administration and systemic availability is high.
Danish: Absorptionen er stort set total efter oral administration, og den systemiske tilgængelighed er høj.
English: The power to detect differences in these two studies was limited.
Danish: Den statistiske mulighed for at finde forskelle i de to studier var begrænset.
English: Flexible quit date between weeks 1 and 5
Danish: Fleksibel ophørsdato mellem uge 1 og 5
English: The day you stop smoking should usually be between day 8 and day 14.
Danish: Den dag De vil stoppe med at ryge, skal sædvanligvis være mellem dag 8 og dag 14.
English: You start with the white tablet and then usually go to the light blue tablet.
Danish: De skal starte med at tage den hvide tablet og sædvanligvis derefter tage den lyseblå tablet.
English: See the chart below for the usual dosing instructions which you should follow from Day 1.
Danish: Se skemaet nedenfor for de sædvanlige dosisanvisninger, som De skal følge fra dag 1
English: Talk to your doctor if you are intending to become pregnant.
Danish: De skal fortælle det til lægen, hvis De planlægger at blive gravid.
English: Patients should be treated with CHAMPIX for 12 weeks.
Danish: Patienter bør behandles med CHAMPIX i 12 uger.
English: It is preferable to avoid the use of CHAMPIX while you are pregnant.
Danish: Det anbefales at undgå brug af CHAMPIX, mens De er gravid.
English: However, it is not known if CHAMPIX actually increases alcohol intoxication.
Danish: Dog vides det ikke om CHAMPIX rent faktisk øger alkoholforgiftning.
English: Blisters: 3 years
Danish: Blister: 3 år.
English: Therefore, unless your doctor instructs you to stop treatment, it is important to keep taking CHAMPIX, according to the instructions described in the table above.
Danish: Med mindre Deres læge giver besked om, at De skal afbryde behandlingen, er det derfor vigtigt, at De bliver ved med at tage CHAMPIX efter de instruktioner, som er beskrevet i tabellen ovenfor.
English: Patients with suicidal ideation and/or behaviour* [n (%)]** Patient-years of exposure
Danish: Patienter med selvmordstanker og/eller -adfærd* [n (%)]** Eksponering i patientår
English: The limited data available from this single smoking cessation study are not sufficient to allow for definitive conclusions to be drawn about the safety in patients with schizophrenia or schizoaffective disorder.
Danish: De begrænsede data fra dette ene rygeophørsstudie er ikke tilstrækkelige til at drage endelige konklusioner omkring sikkerheden hos patienter med skizofreni eller skizoaffektiv sindslidelse.
English: Does not contain a tablet
Danish: Indeholder ingen tablet
English: CHAMPIX with food and drink
Danish: Brug af CHAMPIX sammen med mad og drikke
English: In circulation, varenicline comprises 91% of drug-related material.
Danish: I kredsløbet udgør vareniclin 91 % af al lægemiddelrelateret materiale.
English: Varenicline vs NRT
Danish: Vareniclin vs NRT
English: CHAMPIX is for oral use and the tablets should be swallowed whole with water.
Danish: CHAMPIX er til oral anvendelse, og tabletterne skal synkes hele med vand.
English: Following administration of multiple oral doses to healthy volunteers, steady-state conditions were reached within 4 days.
Danish: Efter administration af flere orale doser hos frivillige, raske forsøgspersoner blev steady state opnået inden for 4 dage.
English: The key results are summarised in the following table:
Danish: De vigtigste resultater er opsummeret i følgende tabel:
English: Apparent volume of distribution averaged 415 litres (%CV= 50) at steady-state.
Danish: Det tilsyneladende fordelingsvolumen er gennemsnitligt 415 liter (%CV=50) ved steady state.
English: Subjects who experienced an adverse event of a concern during previous treatment were excluded.
Danish: Forsøgspersoner, som oplevede en bekymrende bivirkning under tidligere behandling, blev ekskluderet.
English: Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided with additional advice and support.
Danish: Rygestop har større sandsynlighed for at lykkes hos patienter, der er motiverede for at stoppe med at ryge og som modtager yderligere rådgivning og støtte.
English: Observational Studies
Danish: Observationsstudier
English: Not known o Transient loss of consciousness
Danish: - Ikke kendt o Forbigående bevidsthedstab
English: Psychiatric Adverse Events Occurring in ≥ 1% of Patients from Pooled Data from 18 Clinical Trials:
Danish: Psykiatriske bivirkninger, der optræder hos ≥ 1% af patienterne fra poolede data fra 18 kliniske studier:
English: As smoking induces CYP1A2, smoking cessation may result in an increase of plasma levels of CYP1A2 substrates.
Danish: Da rygning inducerer CYP1A2, kan rygeophør resultere i forhøjede plasmakoncentrationer af CYP1A2-substrater.
English: Do not take CHAMPIX:
Danish: Tag ikke CHAMPIX:
English: Start at day 1
Danish: Start på dag 1
English: Date of latest renewal: 29 June 2016
Danish: Dato for første tilladelse: 26. september 2006 Dato for seneste fornyelse: 29. juni 2016
English: Keep the package intact Does not contain any tablets
Danish: Pakningen skal forblive hel Indeholder ingen tablet
English: There were rare reports of life-threatening angioedema requiring urgent medical attention due to respiratory compromise.
Danish: Der er i sjældne tilfælde set livstruende tilfælde af angioødem, der krævede omgående lægehjælp på grund af kompromitteret vejrtrækning.
English: These are equivalent to an estimated increase of 6.5 MACE events and 6.3 MACE events per 1,000 patient-years, respectively of exposure.
Danish: Dette svarer til en estimeret stigning på hhv. 6,5 MACE-tilfælde og 6,3 MACE-tilfælde pr. 1.000 patientår i relation til eksponering.
English: Few patients reported these events in the other three trials (4 varenicline, 3 placebo).
Danish: Kun få patienter rapporterede om disse hændelser i de øvrige tre studier (4 vareniclin og 3 placebo).
English: Patients were stratified by age (12-16 years of age and 17-19 years of age) and by body weight (≤55 kg and >55 kg).
Danish: Patienterne blev stratificeret efter alder (12-16 år og 1719 år) og efter legemsvægt (≤ 55 kg og > 55 kg).
English: Varenicline distributes into tissues, including the brain.
Danish: Vareniclin fordeles i vævet, herunder hjernen.
English: The study in patients with stable cardiovascular disease described above was included in the meta-analysis.
Danish: Studiet med patienter med stabil CVD beskrevet ovenfor var inkluderet i meta-analysen.
English: CA was defined as the proportion of all subjects treated who did not smoke (not even a puff of a cigarette) from Week 9 through Week 52 and did not have an exhaled CO measurement of > 10 ppm.
Danish: CA blev defineret som den del af alle deltagere, som ikke røg (end ikke ét enkelt sug af en cigaret) fra uge 9 til og med uge 52, og som ikke havde en udåndingsmåling af CO > 10 ppm.
English: Before starting your course of CHAMPIX you should usually decide on a date in the second week of treatment (between day 8 and day 14) when you will stop smoking.
Danish: Før De begynder behandlingen med CHAMPIX, skal De sædvanligvis beslutte Dem for en dag i den anden uge af behandlingen (mellem dag 8 og dag 14), hvor De vil holde op med at ryge.
English: Clinicians should be aware of the possible emergence of serious neuropsychiatric symptoms in patients attempting to quit smoking with or without treatment.
Danish: Klinikere skal være opmærksomme på mulig fremkomst af alvorlige neuropsykiatriske symptomer hos patienter, der prøver at stoppe med at ryge med eller uden behandling.
English: Pharmacokinetics in special patient populations
Danish: Farmakokinetik i særlige patientpopulationer
English: The cessation rates in this population were similar to those reported in the general population.
Danish: Rygeophørsraterne i denne population var sammenlignelig med den generelle population.
English: The safety profile of varenicline was comparable to what was reported in other trials in the general population, including pulmonary safety.
Danish: Sikkerhedsprofilen for vareniclin var sammenlignelig med den, der blev set i andre kliniske studier i den generelle population, inklusive lungesikkerhed.
English: Based on post marketing reports, bupropion may be associated with neuropsychiatric adverse events.
Danish: Baseret på indberetninger efter markedsføringen kan bupropion være forbundet med neuropsykiatriske bivirkninger.
English: During follow up
Danish: Under opfølgning
English: There are limited clinical data on any potential interaction between alcohol and varenicline.
Danish: Der foreligger kun begrænsede kliniske data om potentielle interaktioner mellem alkohol og vareniclin.
English: In case of overdose, standard supportive measures should be instituted as required.
Danish: I tilfælde af overdosering anbefales understøttende behandling efter behov.
English: CHAMPIX can be taken with or without food
Danish: CHAMPIX kan tages med eller uden mad.
English: Nicotine competes for the same human α4β2 nAChR binding site for which varenicline has higher affinity.
Danish: Nicotin konkurrerer om det samme humane α4β2 nAChR bindingssted, for hvilket vareniclin har højere affinitet.
English: The elimination half-life of varenicline is approximately 24 hours.
Danish: Halveringstiden for vareniclin er cirka 24 timer.
English: Plasma protein binding of varenicline is low (< 20%) and independent of both age and renal function.
Danish: Vareniclins plasmaproteinbinding er lav (20%), og den er uafhængig af både alder og nyrefunktion.
English: * Of these, one patient in each treatment arm reported suicidal behaviour ** Patients with events up to 30 days after treatment; % are not weighted by study # RR of incidence rates per 100 patient years
Danish: # (RR; 95% CI) * Af disse rapporterede en patient i hver behandlingsarm om selvmordsadfærd ** Patienter med hændelser op til 30 dage efter behandlingen; % er ikke vægtet for hvert studie # RR af incidensrater for hver 100 patientår
English: Patients in this study (n=1,927) received open-label CHAMPIX 1 mg twice daily for 12 weeks.
Danish: Patienterne i dette studie (n=1.927) modtog CHAMPIX open-label 1 mg 2 gange dagligt i 12 uger.
English: The hazard ratio for MACE was higher in patients with cardiovascular risk factors in addition to smoking compared with that in patients without cardiovascular risk factors other than smoking.
Danish: Hazard ratio for MACE var højere hos patienter med kardiovaskulære risikofaktorer sammen med rygning end hos patienter uden andre kardiovaskulære risikofaktorer end rygning.
English: Care should be taken with patients with a history of psychiatric illness and patients should be advised accordingly.
Danish: Der bør udvises forsigtighed ved patienter med tidligere psykisk sygdom, og patienter bør rådgives i henhold hertil.
English: The primary endpoint for CHAMPIX demonstrated statistical superiority to bupropion and placebo.
Danish: Det primære endepunkt for CHAMPIX viste statistisk overlegenhed over for bupropion og placebo.
English: Do not use if box has been opened.
Danish: Må ikke anvendes, hvis kartonen har været åbnet.
English: Study 1 (n=1022)
Danish: Studie 1 (n=1022)
English: The P450 enzymes tested for inhibition were: 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4/5.
Danish: Følgende P450-enzymer er undersøgt for hæmning: 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 og 3A4/5.
English: One outer carton containing:
Danish: 1 ydre karton indeholdende:
English: Weight increased, decreased appetite, increased appetite Hyperglycaemia
Danish: Vægtstigning, nedsat appetit, øget appetit Hyperglykæmi
English: All studies were retrospective cohort studies and included patients with and without a psychiatric history.
Danish: Alle studier var retrospektive kohortestudier og inkluderede patienter med og uden psykiatriske lidelser i anamnesen.
English: Patients who are not willing or able to set the target quit date within 1-2 weeks, could be offered to start treatment and then choose their own quit date within 5 weeks.
Danish: Patienter, der ikke ønsker eller er ude af stand til at fastsætte en ophørsdato inden for 1-2 uger, bør tilbydes, at påbegynde behandlingen og derefter vælge deres egen ophørsdato inden for 5 uger.
English: Contains Blue Box
Danish: Med blå boks
English: The efficacy and safety of varenicline has been evaluated in smokers who had the flexibility of quitting between weeks 1 and 5 of treatment.
Danish: Virkning og sikkerhed af vareniclin er blevet undersøgt hos rygere, der havde muligheden for at holde op med at ryge mellem uge 1 og 5 af behandlingen.