FrancophonIA/ELRC3.0 huggingface dataset:
English: • Throw away used needles in a puncture-resistant container or as recommended byyour healthcare professional.
Danish: • Bortskaf brugte nåle i en egnet beholder til spidse genstande eller i overensstemmelse med din læges eller sygeplejerskes anbefalinger.
English: • This pen is not recommended for use by people who are blind or who cannot see well enough.
Danish: • Er du blind eller svagtseende bør du ikke anvende denne pen, medmindre du får hjælp af en person, som er uddannet i at bruge medicinen korrekt.
English: • Mark the date when you first used your pen and the date 30 days later in the spaces below:
Danish: 30 dage fra denne dato skal du kassere pennen, og denne dato kan du også notere her:
English: STORING YOUR BYETTA PEN
Danish: OPBEVARING AF BYETTA-PENNEN
English: Check Byetta in the cartridge.
Danish: Kontroller Byetta i cylinderampullen.
English: Follow the New Pen Setup only once.
Danish: Pennen skal kun klargøres én gang.
English: Rapid weight loss
Danish: Hurtigt vægttab
English: When immediate-release exenatide was used in combination with a thiazolidinedione, the incidence of hypoglycaemia was similar to that of placebo in combination with a thiazolidinedione.
Danish: Incidensen af hypoglykæmi ved behandling med exenatid opløsning til injektion i kombination med et thiazolidindion er sammenlignelig med incidensen af hypoglykæmi ved kombinationen placebo plus et thiazolidindion.
English: When exenatide was used in combination with metformin alone, no increase in the incidence of hypoglycaemia was observed over that of placebo in combination with metformin which may be due to this glucose-dependent insulinotropic mechanism (see section 4.4).
Danish: Når exenatid blev brugt i kombination med metformin alene, blev der ikke observeret nogen stigning i forekomsten af hypoglykæmi, sammenlignet med placebo i kombination med metformin.
English: • constipation
Danish: • oppustethed
English: How to use Byetta
Danish: Sådan skal du tage Byetta
English: Then turn the dose knob clockwise until appears in the dose window.
Danish: Drej derefter doseringsknappen med uret, indtil er i doseringsvinduet.
English: • Push outer needle shield containing the needle straight onto the pen, then screw needle on until secure.
Danish: • Skub den ydre nålehætte med nål lige ind på pennen, og skru derefter nålen på, indtil den sidder fast.
English: COMMONLY ASKED QUESTIONS
Danish: SPØRGSMÅL OG SVAR
English: Eructation
Danish: Opstød
English: STEP 5 Reset the Pen
Danish: TRIN 5 Nulstilling af pennen
English: • Unscrew the needle.
Danish: • Udskift nålen.
English: Keep your pen and needles out of the sight and reach of children.
Danish: Pennen og nålene skal opbevares utilgængeligt for børn.
English: In patients with mild (creatinine clearance 50 to 80 ml/min) or moderate renal impairment (creatinine clearance 30 to 50 ml/min), exenatide clearance was mildly reduced compared to clearance in individuals with normal renal function (13% reduction in mild and 36% reduction in moderate renal impairment).
Danish: nedsat nyrefunktion, var clearance af exenatid let reduceret sammenlignet med clearance hos personer med normal nyrefunktion (13 % reduktion for mild og 36 % for moderat nedsat nyrefunktion).
English: − Stomach resistant tablets or capsules (e.g.medicines that reduce stomach acid (proton pump inhibitors)) that should not stay too long in your stomach, may need to be taken an hour before,
Danish: (syrepumpe-hæmmere)), som ikke skal blive for længe i maven, kan det være nødvendigt at tage en time før eller fire timer efter dette lægemiddel.
English: For additional information contact your healthcare professional.
Danish: Kontakt din læge eller diabetessygeplejerske for yderligere oplysninger.
English: • Pull dose knob out until it stops and the is in the dose window.
Danish: • Træk doseringsknappen ud, indtil den stopper, og fremkommer i doseringsvinduet.
English: • Remove paper tab from outer needle shield.
Danish: • Fjern beskyttelsesfligen fra den ydre nålehætte.
English: If you use more Byetta than you should
Danish: Hvis du har taget for meget Byetta
English: Particles or discolouration may appear in the cartridge after an injection.
Danish: Efter en injektion kan der være partikler eller misfarvninger i cylinderampullen.
English: • flatulence (passing gas)
Danish: • luft i maven (luftafgang fra tarmen)
English: STEP E Complete New Pen Setup
Danish: TRIN E Afslut klargøring af pennen
English: Byettashould come from needle tip.
Danish: Der skulle komme Byetta ud af nålespidsen.
English: Byetta 5 micrograms solution for injection in pre-filled pen
Danish: Byetta 5 mikrogram, opløsning til injektion i en fyldt pen
English: Byetta 10 micrograms solution for injection in pre-filled pen
Danish: Byetta 10 mikrogram, opløsning til injektion i en fyldt pen
English: Package leaflet: Information for the patient Byetta 5 micrograms solution for injection in pre-filled pen Byetta 10 micrograms solution for injection in pre-filled pen exenatide
Danish: Byetta 5 mikrogram, injektionsvæske, opløsning i en fyldt pen Byetta 10 mikrogram, injektionsvæske, opløsning i en fyldt pen exenatid
English: PEN USER MANUAL Byetta 10 micrograms solution for injection in pre-filled pen (exenatide)
Danish: BRUGSANVISNING TIL PENNEN Byetta 10 mikrogram injektionsvæske, opløsning i en fyldt pen (exenatid)
English: PEN USER MANUAL Byetta 5 micrograms solution for injection in pre-filled pen (exenatide)
Danish: BRUGSANVISNING TIL PENNEN Byetta 5 mikrogram injektionsvæske, opløsning i en fyldt pen (exenatid)
English: See Commonly Asked Questions, number 5, in Section 4 of this user manual.
Danish: nummer 9, i afsnit 4 i denne brugsanvisning.
English: Byetta 5 micrograms solution for injection in pre-filled pen exenatide
Danish: Byetta 5 mikrogram injektionsvæske, opløsning i fyldt pen exenatid
English: Byetta 10 micrograms solution for injection in pre-filled pen exenatide
Danish: Byetta 10 mikrogram injektionsvæske, opløsning i fyldt pen exenatid
English: Angioneurotic oedema
Danish: Angioneurotisk ødem Nyrer og urinveje
English: Macular and papular rash
Danish: Makulært eller papulært udslæt
English: In use pen: Store below 25 ºC.
Danish: Efter ibrugtagning Opbevares ved temperaturer under 25 ºC.
English: • Grip pen firmly.
Danish: • Hold pennen fast i hånden.
English: Blue Pen Cap
Danish: Blå Penhætte
English: • Turn dose knob clockwise until it stops and the is in the dose window.
Danish: • Drej doseringsknappen med uret, indtil den stopper, og er i doseringsvinduet.
English: Do not store the pen with the needle attached.
Danish: Opbevar ikke pennen med påsat nål.
English: Nervous system disorders
Danish: Mave-tarm-kanalen Tarmobstruktion Kvalme
English: • DO NOT TRANSFER THE MEDICINE IN THE BYETTA PEN TO A SYRINGE.
Danish: • DENNE MEDICIN MÅ IKKE OVERFØRES TIL EN SPRØJTE.
English: • indigestion
Danish: • fordøjelsesproblemer
English: • Difficulty to swallow
Danish: • øget tendens til at bøvse
English: • hypoglycaemia
Danish: • hypoglykæmi (lavt blodsukker)
English: In use pen: 30 days
Danish: Ibrugtaget pen:
English: Acute pancreatitis (see section 4.4)
Danish: Mavesmerter Gastroøsofageal reflukssygdom Oppustethed Akut pancreatitis (se pkt.
English: Do not repeat Section 2 for routine use, if you do, you will run out of Byetta before 30 days of use.
Danish: Du skal ikke gentage afsnit 2 ved rutinemæssig brug.
English: Front
Danish: Administration
English: • Pull off outer needle shield.
Danish: • Træk den ydre nålehætte af.
English: • Do not store the Byettapen with the needle attached.
Danish: • Byetta-pennen må ikke opbevares med påsat nål.
English: Constipation
Danish: Nervøsitet
English: Byetta should be injected into your abdomen, thigh, or upper arm using the injection technique recommended by your healthcare professional.
Danish: Stik nålen ind i huden ved brug af den injektionsteknik, som din læge eller diabetessygeplejerske har anbefalet.
English: The Reference Member State was Denmark and the Concerned Member States were: United Kingdom.
Danish: Referencemedlemsstaten var Danmark og den berørte medlemsstat var: Det Forenede Kongerige.
English: The Mutual Recognition Procedure started on 15 September 2005.
Danish: Den gensidige anerkendelsesprocedure indledtes den 15. september 2005.
English: The Denmark referred the reasons for disagreement to the EMEA on 3 March 2006.
Danish: Danmark fremsendte begrundelserne for uenighederne til EMEA den 3. marts 2006.
English: The arbitration procedure started on 23 March 2006.
Danish: Voldgiftsproceduren indledtes den 23. marts 2006.
English: Generics Ltd. submitted applications for mutual recognition of Doxagamma 4 mg prolonged release tablets and associated names on the basis of the marketing authorisation granted by the Denmark on 30 September 2002.
Danish: Generics Ltd. indgav ansøgninger om gensidig anerkendelse af Doxagamma 4 mg depottabletter og tilknyttede navne på grundlag af den markedsføringstilladelse, Danmark udstedte den 30. september 2002.
English: The Marketing Authorisation Holder provided written explanations on 08 April 2006.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 8. april 2006.
English: The scope of the referral was to agree whether Doxagamma 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food.
Danish: Formålet med indbringelsen var at opnå enighed om, hvor vidt frigivelsesprofilen for Doxagamma 4 mg depottabletter afviger væsentligt fra det oprindelige lægemiddel og eventuelt medfører øget forekomst af bivirkninger såsom svimmelhed og hypotension, hvorvidt der er væsentlige forskelle i resultaterne af testbatcher i enkeltdosisfasen af undersøgelserne 5208 og 1995 og hvor vidt ansøgeren ved udformningen af bioækvivalensundersøgelserne afviger fra CHMP's retningslinjer, navnlig når det gælder virkningen af fødevarer.
English: Doxagamma 4 mg prolonged release tablets and associated names (doxazosin) is a receptor alfa blocking agent used in the treatment of patients with essential hypertension and in the symptomatic treatment of patients with benign prostatic hyperplasia.
Danish: Doxagamma 4 mg depottabletter og tilknyttede navne (doxazosin) er et alfa-1-receptor-blokerende stof, som anvendes til behandling af patienter med essentiel hypertension og til symptomatisk behandling af benign prostatahyperplasi.
English: During the June 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Doxagamma 4 mg prolonged release tablets and associated names, that the objections raised should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Danish: I lyset af de samlede data, der var blevet fremlagt, og den faglige debat i udvalget var CHMP på sit møde i juni 2006 af den opfattelse, at benefit-risk forholdet er gunstigt for Doxagamma 4 mg depottabletter og tilknyttede navne, at de rejste indvendinger ikke bør forhindre udstedelse af en markedsføringstilladelse, og at referencemedlemsstatens produktresumé, etikettering og indlægsseddel bør ændres.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Doxagamma 4 mg prolonged release tablets and associated names International Non-Proprietary Name (INN): Doxazosin
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 21, OM Doxagamma” 4 mg depottabletter og tilknyttede navne Internationalt fællesnavn ( INN): Doxazosin
English: Day 60 of the CMDh procedure was on 2 August 2018.
Danish: Dag 60 i CMDh-proceduren var den 2. august 2018.
English: The Pharmacokinetics Working Party (PKWP) and the Modelling and Simulation Working Party (MSWP) were also consulted during the CMDh procedure.
Danish: Arbejdsgrupperne Pharmacokinetics Working Party (PKWP) og Modelling and Simulation Working Party (MSWP) blev også hørt i løbet af CMDh-proceduren.
English: • The Committee considered the totality of the data submitted by the applicant in relation to the objections raised as a potential serious risk to public health.
Danish: • Udvalget vurderede alle de data, som ansøgeren havde fremsendt, i forhold til indvendingerne vedrørende en mulig alvorlig risiko for den offentlige sundhed.
English: There is also no risk of the active substances not being released over 28 days as there is an excess of active substances present in the ring.
Danish: Der er heller ingen risiko for, at de aktive stoffer ikke bliver frigivet over 28 dage, da der er et overskud af dem i ringen.
English: Perlinring 0.12mg/0.015mg/day is a vaginal delivery system containing etonogestrel and ethinylestradiol.
Danish: Perlinring 0,12 mg/0,015 mg/dag er et vaginalindlæg, der indeholder etonogestrel og ethinylestradiol.
English: The contraceptive effect of the vaginal delivery system is based on various mechanisms, the most important of which is the inhibition of ovulation.
Danish: Den præventive effekt af vaginalindlægget er baseret på forskellige mekanismer, hvoraf den vigtigste er hæmningen af ægløsning.
English: Additionally, the stability of the formulation has been shown to be maintained under extreme storage conditions with in vitro performance maintained.
Danish: Desuden er det påvist, at formuleringens stabilitet, herunder in vitroperformance, fastholdes under ekstreme opbevaringsbetingelser.
English: Etonogestrel (ENG) is a 19-nortestosterone-derived progestagen and binds with high affinity to progesterone receptors in the target organs.
Danish: Etonogestrel (ENG) er et 19-nortestosteron-afledt progestagen, som med høj affinitet binder til progesteronreceptorer i målorganerne.
English: Manual stress (in-process control) and tensile strength (finished product specification) are performed on the ring during manufacture and the ring is not expected to lose its integrity after 3 weeks of use.
Danish: Manuel belastning (proceskontrol) og tensil styrketest (specifikation for det færdige produkt) er gennemført på ringen under fremstillingen, og ringens holdbarhed forventes ikke at være påvirket efter tre ugers brug.
English: The Committee, as a consequence, considers that the benefit-risk balance of Perlinring and associated names is favourable and therefore recommends the granting of the marketing authorisation(s) for the medicinal products referred to in Annex I of the CHMP opinion.
Danish: Udvalget finder følgelig, at benefit/risk-forholdet for Perlinring og relaterede navne er positivt, og anbefaler derfor udstedelse af markedsføringstilladelse for de lægemidler, der er anført i bilag 1 til
English: Therefore the CHMP agreed by majority, that the extended use of up to 28 days is supported by the totality of the data submitted by the applicant.
Danish: Med en flertalsafgørelse fandt CHMP derfor, at den forlængede brug i op til 28 dage er understøttet af de samlede data, som ansøgeren har indsendt.
English: As no agreement could be reached during the CMDh procedure, a referral under Article 29(4) of Directive 2001/83/EC was triggered by the reference Member State United Kingdom (UK) on 7 August 2018.
Danish: Da de berørte parter ikke kunne nå til enighed under CMDh-proceduren, indledte referencemedlemsstaten (Storbritannien) den 7. august 2018 en indbringelsesprocedure i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF.
English: In summary, scientific evidence supports that the generic product and reference medicinal product would behave similarly after Day 21 up to Day 28 of use.
Danish: Samlet set understøtter den videnskabelige evidens, at det generiske produkt og referencelægemidlet vil opføre sig på samme måde mellem dag 21 og dag 28.
English: Furthermore, the vaginal ring integrity is not expected to be affected if retained over the period of 28 days.
Danish: Desuden forventes vaginalringens holdbarhed ikke at blive påvirket ved brug i op til 28 dage.
English: Ethinylestradiol (EE) is an estrogen widely used in contraceptive products.
Danish: Ethinylestradiol (EE) er et østrogen, der anvendes i vid udstrækning i præventionsmidler.
English: The tolerability of the ring after 28 days is also not expected to raise concerns given that the test and reference medicinal products have a similar polymer, active amounts and ring dimensions.
Danish: Ringens tolerabilitet efter 28 dage forventes heller ikke at give anledning til bekymring, idet det omhandlede produkt og referencelægemidlet har samme polymer, samme mængde aktivt stof og samme dimensioner.
English: This modelling, together with the following information below was considered to provide further reassurance for the extended use up to 28 days:
Danish: Ansøgeren fandt, at denne modellering sammen med følgende oplysninger gav yderligere belæg for forlænget brug i op til 28 dage:
English: The etonogestrel/ethinylestradiol combined contraceptive vaginal ring provides continuous delivery of contraceptive steroids through the vagina, avoiding the need for daily drug administration.
Danish: Vaginalringen, der indeholder en kombination af etonogestrel og ethinylestradiol, frigiver løbende kontraceptive steroider i skeden, og derved undgås behovet for daglig administration.
English: As mentioned above there is a significant residual amount of drug in both the test and the reference medicinal product at 21 days (residual content for test and reference products is approximately 87% vs. 86% for EE and for ENG 78% vs. 75% of the initial concentration remaining).
Danish: Som nævnt ovenfor er der en signifikant restmængde af lægemidlet i både det omhandlede produkt og referencelægemidlet efter 21 dage (restmængden for det omhandlede produkt og referencelægemidlet er hhv. ca. 87 % og 86 % for ethinylestradiol og 78 % og 75 % for etonogrestrel af den oprindelige mængde).
English: • The Committee was of the view that the totality of data submitted justified the maintenance of the contraceptive efficacy up to 28 days for Perlinring, in line with the reference medicinal product NuvaRing.
Danish: • Udvalget var af den opfattelse, at de indsendte data alt i alt påviste fastholdelse af den præventive effekt i op til 28 dage for Perlinring i overensstemmelse med referencelægemidlet NuvaRing.
English: The Committee considered the available data submitted in support of the use of Perlinring during an extended week up to 28 days, which included in vivo-in vitro correlation, pharmaceutical data such as in vitro dissolution and residual content, and ring integrity and tolerability.
Danish: Udvalget vurderede de tilgængelige data, der var indsendt til støtte for den forlængede brug af Perlinring i op til 28 dage, herunder in vivo-in vitro-korrelationsdata, farmaceutiske data som f.eks. in vitro-opløsning og restmængde, samt data for tolerabilitet og ringens holdbarhed.
English: Considering that the recommended posology of 21 days is supported by a bioequivalence study, the issue raised and discussed at the CHMP concerned the additional data submitted to support the use between day 21 and day 28 and whether these data were considered acceptable to support the extended use of up to 28 days (in line with the reference medicinal product).
Danish: I betragtning af, at den anbefalede dosering på 21 dage er understøttet af et bioækvivalensstudie, vedrørte den problemstilling, der blev rejst og drøftet i CHMP, de yderligere data, der var indsendt til støtte for brug mellem dag 21 og dag 28, herunder om disse data kunne anses for acceptable til støtte for den forlængede brug i op til 28 dage (i overensstemmelse med referencelægemidlet).
English: Bioequivalence of the proposed product to the reference medicinal product was demonstrated only for the period of 21 days, but not for 28 days.
Danish: Det omhandlede produkts bioækvivalens med referencelægemidlet er kun påvist i 21 dage, ikke 28 dage.
English: The sampling period of 21 days in the conducted bioequivalence study is in line with the recommended use of the product, and it is undisputed that the evidence for bioequivalence of the test product Perlinring and the reference medicinal product NuvaRing has been adequately demonstrated for the recommended duration of use.
Danish: Undersøgelsesperioden på 21 dage i det gennemførte bioækvivalensstudie er i overensstemmelse med den anbefalede brug af produktet, og der er enighed om, at bioækvivalensen mellem det omhandlede produkt (Perlinring) og referencelægemidlet NuvaRing er tilstrækkeligt påvist i den anbefalede brugsperiode.
English: However, the objecting CMSs (DE, NL and FR) contended that Perlinring 0.12mg/0.015mg per 24 hours vaginal delivery system is not approvable since the evidence for its use between day 21 and day 28 is built only on extrapolation, and bioequivalence in this period is considered not proven.
Danish: De anfægtende medlemsstater (Tyskland, Holland og Frankrig) anførte, at vaginalringen Perlinring 0,12 mg/0,015 mg pr. 24 timer ikke kan godkendes, da evidensen for brug mellem dag 21 og dag 28 kun bygger på ekstrapolering af data, og da bioækvivalensen i denne periode ikke kan anses for at være påvist.
English: The reference Member State (RMS) United Kingdom, considered that, based on the totality of available data and in particular owing to the comparable pharmaceutical data, the similar residual content of EE and ENG, it is possible to conclude with a sufficient degree of certainty that bioequivalence of test and reference medicinal product is maintained over the period of 28 days.
Danish: Referencemedlemsstaten (Storbritannien) fandt på grundlag af de samlede, tilgængelige data og navnlig de sammenlignelige farmaceutiske data, at den ensartede restmængde af EE og ENG gør det muligt med en vis grad af sikkerhed at fastslå, at bioækvivalensen mellem det omhandlede produkt og referencelægemidlet fastholdes over perioden på 28 dage.
English: The lack of in vivo data supporting the extended ring use (of up to 28 days), which is stated as a deviation from the recommended regimen (21 days) in line with information included in the product information of the reference medicinal product NuvaRing, was considered to be a potential serious risk to public health (PSRPH).
Danish: Manglen på in vivo-data til understøttelse af den forlængede brug af ringen (op til 28 dage), som er anført som en afvigelse fra det anbefalede regime (21 dage) i produktinformationen for referencelægemidlet NuvaRing, ansås for at udgøre en mulig alvorlig risiko for den offentlige sundhed.
English: Although it is recognised that the model is not a surrogate for demonstrating bioequivalence (as in vitro data are generally not accepted to demonstrate bioequivalence), exceptions do exist such as in the case of BCSbased biowaiver.
Danish: Selvom det anerkendes, at modellen ikke kan erstatte påvisning af bioækvivalens (idet in vitro-data generelt ikke accepteres ifm.
English: ENG/EE ring is indicated for contraception and is intended for women of fertile age.
Danish: Vaginalringen med ENG/EE er indiceret til prævention hos kvinder, der kan blive gravide.
English: Pharmaceutical equivalence of test and reference medicinal product, and comparable in vitro dissolution data evaluating the rate of release of both over 28 days has been demonstrated
Danish: Der er påvist farmaceutisk ækvivalens mellem det omhandlede produkt og referencelægemidlet, ligesom in vitro-data for frigivelseshastigheden for begge produkter over 28 dage er sammenlignelige.