FrancophonIA/ELRC3.0 huggingface dataset:
English: The effect of umeclidinium/vilanterol on the QT interval was evaluated in a placebo and active (moxifloxacin) controlled QT study involving once daily administration of umeclidinium/vilanterol 113/22 micrograms or 500/100 micrograms (pre-dispensed dose with umeclidinium at eight times the recommended dose and vilanterol at four times the recommended dose) for 10 days in 103 healthy volunteers.
Danish: Effekten af umeclidinium/vilanterol på QT-intervallet blev vurderet i et placebo- og aktiv (moxifloxacin)kontrolleret QT-studie, hvor umeclidinium/vilanterol 113/22 mikrogram eller 500/100 mikrogram (afdelt dosis med 8 gange den anbefalede dosis af umeclidinium og 4 gange den anbefalede dosis af vilanterol) blev administreret én gang daglig i 10 dage, hos 103 raske personer.
English: No clinically relevant effects of hypokalaemia were observed in clinical studies with umeclidinium/vilanterol at the recommended therapeutic dose.
Danish: Der er ikke set klinisk relevante virkninger af hypokaliæmi i kliniske studier med umeclidinium/vilanterol ved den anbefalede terapeutiske dosis.
English: There are no data on the effects of umeclidinium/vilanterol on human fertility.
Danish: Der foreligger ingen data om virkningen af umeclidinium/vilanterol på fertilitet hos mennesker.
English: The comparison of FF/UMEC/VI to FF/VI and UMEC/VI resulted in a statistically significant 14.8% reduction in risk of a moderate/severe exacerbation (based on analysis of time to first exacerbation) (Hazard Ratio 0.85; 95% CI: 0.80, 0.91; p<0.001) and 16.0% reduction in risk of a moderate/severe exacerbation respectively (based on analysis of time to first exacerbation) (Hazard Ratio 0.84; 95% CI: 0.78, 0.91; p<0.001).
Danish: Sammenligningen af FF/UMEC/VI med FF/VI og UMEC/VI resluterede i en statistisk signifikant reduktion i risikoen for en moderat/svær eksacerbation (baseret på analyse af tiden til første eksacerbation) på henholdsvis 14,8% (hazard ratio 0,85; 95% CI: 0,80, 0,91; p< 0,001) og 16,0% (hazard ratio 0,84; 95% CI: 0,78, 0,91; p< 0,001).
English: Inhalation powder, pre-dispensed 1 inhaler of 30 doses
Danish: Inhalationspulver, afdelt 1 inhalator med 7 doser 1 inhalator med 30 doser
English: Contents of the pack and other information What ANORO ELLIPTA contains
Danish: Pakningsstørrelser og yderligere oplysninger Anoro Ellipta indeholder:
English: ANORO ELLIPTA 55/22 micrograms also showed statistically significant improvements compared with placebo in change from baseline in lung volume measures at trough and at 3 hours post dose at Week 12 in the first study (inspiratory capacity: 237 ml and 316 ml respectively, residual volume: -466 ml and -643 ml respectively and functional residual capacity: -351 ml and -522 ml respectively; all p<0.001).
Danish: Anoro Ellipta 55/22 mikrogram viste desuden statistisk signifikante forbedringer sammenlignet med placebo i ændring fra baseline af lungevolumen, målt ved trough og 3 timer efter dosering ved uge 12 i det første studie (inspiratorisk kapacitet: henholdsvis 237 ml og 316 ml, residualvolumen: henholdsvis -466 ml og -643 ml, samt funktionel residualkapacitet: henholdsvis -351 ml og -522 ml, alle p < 0,001).
English: Animal studies indicate no effects of umeclidinium or vilanterol on fertility.
Danish: Dyrestudier viste ingen effekt af umeclidinium/vilanterol på fertiliteten.
English: Multipack: 90 (3 packs of 30) doses
Danish: Inhalationspulver, afdelt Multipakning: 90 doser (3 pakninger med 30 doser)
English: ANORO ELLIPTA contains lactose
Danish: Anoro Ellipta indeholder lactose
English: The maximum mean difference in prolongations of QT interval (corrected using the Fridericia method, QTcF) from placebo after baseline-correction was 4.3 (90% CI=2.2 to 6.4) milliseconds seen 10 minutes after administration with umeclidinium/vilanterol 113/22 micrograms and 8.2 (90% CI=6.2 to 10.2) milliseconds seen 30 minutes after administration with umeclidinium/vilanterol 500/100 micrograms.
Danish: Den maksimale middelforskel i forlængelse af QT-intervallet (korrigeret ved Fridericias metode, QTcF) i forhold til placebo efter baseline-korrektion var 4,3 millisekunder (90 % CI = 2,2 til 6,4) set 10 minutter efter administration af umeclidinium/vilanterol 113/22 mikrogram og 8,2 millisekunder (90 % CI = 6,2 til 10,2) set 30 minutter efter administration af umeclidinium/vilanterol 500/100 mikrogram.
English: No effect of verapamil was observed on umeclidinium or vilanterol Cmax.
Danish: Der blev ikke observeret nogen effekt af verapamil på Cmax for umeclidinium eller vilanterol.
English: The “Discard by” date is 6 weeks from the date of opening the tray.
Danish: Datoen ”Kasseres senest” er 6 uger fra den dag, hvor bakken blev åbnet.
English: ANORO ELLIPTA (N = 207) versus tiotropium 18 mcg (N = 203) (Study DB2113360)
Danish: Anoro Ellipta (N=207) versus tiotropium 18 mikrogram (N=203) (studie DB2113360)
English: ANORO ELLIPTA demonstrated a statistically significant and clinically meaningful reduction in breathlessness as evaluated by an increase in TDI focal score at Week 24 (key secondary end-point) compared with placebo (see Table 1).
Danish: Anoro Ellipta viste en statisk signifikant og klinisk relevant reduktion i åndenød, ved vurdering ud fra en stigning i TDI (Transition Dyspnea Index) fokal score ved uge 24 (sekundært endepunkt) sammenlignet med placebo (se tabel 1).
English: Umeclidinium/vilanterol has not been evaluated in patients with severe hepatic impairment.
Danish: Umeclidinium/vilanterol er ikke vurderet hos patienter med svært nedsat leverfunktion.
English: In a 24-week placebo-controlled study in patients with symptomatic COPD, ANORO ELLIPTA reduced the risk of a moderate/severe COPD exacerbation by 50% compared with placebo (based on analysis of time to first exacerbation: Hazard Ratio (HR) 0.5; 95% CI: 0.3, 0.8; p=0.004*); by 20% compared with umeclidinium (HR 0.8; 95% CI: 0.5, 1.3; p=0.391); and by 30% compared with vilanterol (HR 0.7; 95% CI: 0.4, 1.1; p=0.121).
Danish: I et 24 ugers placebokontrolleret studie hos patienter med symptomatisk KOL, reducerede Anoro Ellipta risikoen for moderat/svær KOL-eksacerbation med 50 % sammenlignet med placebo (baseret på analyse af tiden til første eksacerbation; hazard ratio (HR) 0,5; 95% CI:0,3, 0,8; p = 0,004*), med 20 % sammenlignet med umeclidinium (HR 0,8; 95% CI: 0,5, 1,3; p = 0,391) og med 30 % sammenlignet med vilanterol (HR 0,7; 95% CI: 0,4, 1,1; p = 0,121).
English: ANORO ELLIPTA is for inhalation use.
Danish: Anoro Ellipta er til inhalationsbrug.
English: This corresponds to a pre-dispensed dose of 74.2 micrograms umeclidinium bromide equivalent to 62.5 micrograms umeclidinium and 25 micrograms vilanterol (as trifenatate).
Danish: Dette svarer til en afdelt dosis på 74,2 mikrogram umeclidiniumbromid svarende til 62,5 mikrogram umeclidinium og 25 mikrogram vilanterol (som trifenatat).
English: Hypersensitivity reactions including: Rash
Danish: Overfølsomhedsreaktioner, herunder Udslæt
English: Do not use this medicine after the expiry date which is stated on the carton, tray and inhaler after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The inhaler contains two aluminium foil laminate blisters of 7 or 30 doses.
Danish: Inhalatoren indeholder to laminerede aluminiumsfolie-blister (en for hvert aktivt stof) med enten 7 eller 30 doser.
English: In vitro studies showed that vilanterol is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter.
Danish: In vitro-studier viste, at vilanterol primært metaboliseres via cytochrom P450 3A4 (CYP3A4) og er et substrat for transportproteinet P-glykoprotein (P-gp).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 55 micrograms/22 micrograms
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INTERMEDIÆR YDRE KARTON (UDEN BLUE BOX - KUN MULTIPAKNING) 55 mikrogram/22 mikrogram
English: The “Discard by” date is 6 weeks from the date you open the tray.
Danish: Datoen ”Kasseres senest” er 6 uger efter den dag, hvor bakken åbnes.
English: In the second study, ANORO ELLIPTA 55/22 micrograms showed improvements compared with placebo in change from baseline in lung volume measures at trough and at 3 hours post dose at Week 12 (inspiratory capacity: 198 ml and 238 ml respectively, residual volume: -295 ml and -351 ml respectively and functional residual capacity: -238 ml and -302 ml respectively); all p<0.001∗).
Danish: I det andet studie viste Anoro Ellipta 55/22 mikrogram forbedringer sammenlignet med placebo i ændring fra baseline af lungevolumen, målt ved trough og 3 timer efter dosering ved uge 12 (inspiratorisk kapacitet: henholdsvis 198 ml og 238 ml, residualvolumen: henholdsvis -295 ml og -351 ml og funktionel residualkapacitet: henholdsvis -238 ml og -302 ml, alle p < 0,001∗).
English: No clinically relevant effects on plasma glucose were observed in clinical studies with umeclidinium/vilanterol at the recommended therapeutic dose.
Danish: Der er ikke set kliniske relevante påvirkninger af plasmaglukose i kliniske studier med umeclidinium/vilanterol ved den anbefalede terapeutiske dosis.
English: ANORO ELLIPTA is for inhalation use only.
Danish: Anoro Ellipta er kun beregnet til inhalation.
English: ANORO ELLIPTA (N = 217) versus tiotropium 18 mcg (N = 215) (Study DB2113374)
Danish: Anoro Ellipta (N=217) versus tiotropium 18 mikrogram (N=215) (studie DB2113374)
English: Open the cover when ready to inhale a dose.
Danish: Åbn beskyttelseshætten, når du er klar til at inhalere en dosis.
English: These may affect up to 1 in 1,000 people:
Danish: Kan forekomme hos op til 1 ud af 1.000 personer:
English: Pack sizes of 7 or 30 dose inhalers.
Danish: Pakningsstørrelser med inhalator med 7 eller 30 doser.
English: The mouthpiece of the inhaler may be cleaned using a dry tissue before closing the cover.
Danish: Inhalatorens mundstykke kan rengøres med en tør serviet, før beskyttelseshætten lukkes c) Luk inhalatoren
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX- MULTIPACK) 55 micrograms/22 micrograms
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERETIKET (MED BLUE BOX - MULTIPAKNING) 55 mikrogram/22 mikrogram
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS) 55 micrograms/22 micrograms
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (ENKELTPAKNINGER) 55 mikrogram/22 mikrogram
English: • sore throat
Danish: • ømhed i halsen
English: The clinical development programme included 2,354 patients who received umeclidinium/vilanterol once daily in the Phase III clinical studies of 24 weeks or more, of whom 1,296 patients received the recommended dose of 55/22 micrograms in 24-week studies, 832 patients received a higher dose of 113/22 micrograms in 24-week studies and 226 patients received 113/22 micrograms in a 12-month study.
Danish: Det kliniske udviklingsprogram inkluderede 2.354 patienter, der fik umeclidinium/vilanterol én gang daglig i et klinisk fase III-studie, der varede 24 uger eller længere, hvor 1.296 patienter fik den anbefalede dosis på 55/22 mikrogram i studier af 24 ugers varighed.
English: Based on the magnitude of these changes, no clinically relevant drug interaction is expected when umeclidinium/vilanterol is co-administered with P-gp inhibitors.
Danish: Der forventes ingen klinisk relevant lægemiddelinteraktion på baggrund af størrelsesordenen af disse ændringer, når umeclidinium/vilanterol administreres samtidigt med P-gp-hæmmere.
English: Treatment with umeclidinium/vilanterol should be discontinued immediately if paradoxical bronchospasm occurs and alternative therapy instituted if necessary.
Danish: Hvis der opstår paradoks bronkospasme, skal behandlingen med umeclidinium/vilanterol omgående seponeres og anden behandling iværksættes, hvis det er nødvendigt.
English: The Ellipta inhaler consists of a light grey plastic body, a red mouthpiece cover and a dose counter.
Danish: Ellipta-inhalatoren består af en lysegrå inhalator af plast med en rød beskyttelseshætte over mundstykket og en dosistæller.
English: Bladder outlet obstruction
Danish: Obstipation Mundtørhed
English: Other medicines and ANORO ELLIPTA
Danish: Brug af anden medicin sammen med Anoro Ellipta
English: Oropharyngeal pain Dysphonia
Danish: Orofaryngeale smerter Dysfoni
English: Patients with moderate hepatic impairment (Child-Pugh Class B) showed no evidence of an increase in systemic exposure to either umeclidinium or vilanterol (Cmax and AUC) following administration of umeclidinium/vilanterol with umeclidinium at twice the recommended dose and vilanterol at the recommended dose and no evidence of altered protein binding between patients with moderate hepatic impairment and healthy volunteers.
Danish: Efter administration af umeclidinium/vilanterol med 2 gange den anbefalede dosis af umeclidinium og den anbefalede dosis af vilanterol, viste patienter med moderat nedsat leverfunktion (Child-Pugh-klasse B) ingen tegn på øget systemisk eksponering over for hverken umeclidinium eller vilanterol (Cmax og AUC), og der var ingen tegn på ændret proteinbinding mellem patienter med moderat nedsat leverfunktion og raske personer.
English: ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed
Danish: Anoro Ellipta 55 mikrogram/22 mikrogram inhalationspulver, afdelt
English: Urinary tract infection Sinusitis
Danish: Urinvejsinfektion Sinuitis
English: Component of a multipack, can't be sold separately.
Danish: Inhalationspulver, afdelt 1 inhalator med 30 doser Del af en multipakning, må ikke sælges separat.
English: ANORO ELLIPTA reduced the use of rescue medication with salbutamol over Weeks 1-24 compared with placebo and umeclidinium (see Table 1) and demonstrated an increase from baseline in the proportion of days when no rescue medication was needed (on average 11.1%) compared with a decrease from baseline on placebo (on average 0.9%).
Danish: Anoro Ellipta viste en stigning fra baseline i antal dage uden behov for anfaldsmedicin (gennemsnitligt 11,1 %) sammenlignet med et fald fra baseline med placebo (gennemsnitligt
English: ANORO ELLIPTA 55/22 mcg inhalation powder umeclidinium/vilanterol
Danish: Anoro Ellipta 55/22 mikrog inhalationspulver umeclidinium/vilanterol
English: triple combinations with corticosteroids, ATC code: R03AL03
Danish: Farmakoterapeutisk klassifikation: Midler mod obstruktiv lungesygdom, adrenergika i kombination med antikolinergika, herunder trestof-behandling med kortikosteroider, ATC-kode: R03AL03.
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Priory Street
Danish: Glaxo Operations UK Limited (handler som Glaxo Wellcome Operations) Priory Street
English: Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations) Harmire Road
Danish: Glaxo Operations UK Ltd. (handler som Glaxo Wellcome Operations) Harmire Road
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Harmire Road
Danish: Glaxo Operations UK Limited (handler som Glaxo Wellcome Operations) Harmire Road
English: Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms vilanterol (as trifenatate).
Danish: Hver afgivet dosis indeholder 55 mikrogram umeclidinium (svarende til 65 mikrogram umeclidiniumbromid) og 22 mikrogram vilanterol (som trifenatat).
English: Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations) Priory Street
Danish: Glaxo Operations UK Ltd. (handler som Glaxo Wellcome Operations) Priory Street
English: ANORO ELLIPTA 55/22 micrograms improved exercise endurance time compared with placebo, as evaluated with the endurance shuttle walk test (ESWT), in one study but not the second and improved lung volume measures compared with placebo in both studies in adult COPD patients with hyperinflation (functional residual capacity [FRC] >120%).
Danish: Anoro Ellipta 55 mikrogram forbedrede fysisk udholdenhed målt ved fysisk anstrengelse sammenlignet med placebo, vurderet ved Endurance Shuttle Walk Test (ESWT) i ét studie, men ikke i det andet.
English: Umeclidinium is a substrate of cytochrome P450 2D6 (CYP2D6).
Danish: Umeclidinium er substrat for CYP2D6.
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 65 micrograms umeclidinium bromide equivalent to 55 micrograms of umeclidinium and 22 micrograms of vilanterol (as trifenatate).
Danish: Hver enkelt inhalation leverer en afgivet dosis (den dosis, der forlader mundstykket) på 65 mikrogram umeclidiniumbromid svarende til 55 mikrogram umeclidinium og 22 mikrogram vilanterol (som trifenatat).
English: LIST OF EXCIPIENTS
Danish: KOL- eksacerbationer
English: Don't use this medicine if you are pregnant unless your doctor tells you that you can.
Danish: Hvis du er gravid, må du ikke tage dette lægemiddel, medmindre du har aftalt det med lægen.
English: ANORO ELLIPTA (N =
Danish: Anoro Ellipta (N=413) versus
English: ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed umeclidinium/vilanterol
Danish: Anoro Ellipta 55 mikrogram/22 mikrogram inhalationspulver, afdelt umeclidinium/vilanterol
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate)
Danish: Hver enkelt inhalation afgiver en leveret dosis (den dosis, der afgives fra mundstykket) på 55 mikrogram umeclidinium (svarende til 65 mikrogram umeclidiniumbromid) og 22 mikrogram vilanterol (som trifenatat).
English: Rare Rare Rare
Danish: Sjælden Sjælden Sjælden
English: Constipation Dry mouth
Danish: Tørremiddel Bakke
English: • tremor
Danish: • udslæt
English: In addition, no clinically significant effects on cardiac rhythm were observed on 24-hour Holter monitoring in 53 patients with COPD who were treated with umeclidinium/vilanterol 55/22 micrograms once daily in
Danish: Derudover blev der ikke observeret nogen klinisk signifikante effekter på hjerterytmen ved 24-timers Holtermonitorering hos 53 patienter med KOL, der blev behandlet med umeclidinium/vilanterol 55/22 mikrogram én gang daglig i et studie af 6 måneders varighed eller hos yderligere 55 patienter, der fik umeclidinium/vilanterol 113/22 mikrogram én gang daglig i et andet studie af 6 måneders varighed samt 226 patienter, der umeclidinium/vilanterol 113/22 mikrogram én gang daglig i studiet af 12 måneders varighed.
English: Don't use this medicine if you are breast-feeding unless your doctor tells you that you can.
Danish: Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: If you accidentally use too much of this medicine, contact your doctor or pharmacist for advice immediately as you may need medical attention.
Danish: Kontakt straks lægen eller apoteket, hvis du ved et uheld har taget for meget af Anoro Ellipta, da du kan have brug for lægehjælp.
English: one 6-month study, or in a further 55 patients who received umeclidinium/vilanterol 113/22 micrograms once daily in another 6-month study and 226 patients who received 113/22 micrograms once daily in the 12-month study.
Danish: 832 patienter fik en højere dosis på 113/22 mikrogram i studier af 24 ugers varighed og 226 patienter fik 113/22 mikrogram i et studie af 12 måneders varighed.
English: In a pre- and post-natal study, subcutaneous administration of umeclidinium to rats resulted in lower maternal body weight gain and food consumption and slightly decreased pre-weaning pup body weights in dams given 180 micrograms/kg/day dose (approximately 80-times the human clinical exposure of umeclidinium 55 micrograms, based on AUC).
Danish: I et studie af den præ- og postnatale udvikling hos rotter resulterede subkutan administration af umeclidinium i lavere vægtstigning og nedsat fødeindtagelse hos moderen, og i let nedsatte kropsvægte hos afkommet inden fravænning.
English: Patients with severe renal impairment showed no evidence of an increase in systemic exposure to either umeclidinium or vilanterol (Cmax and AUC) following administration of umeclidinium/vilanterol with umeclidinium at twice the recommended dose and vilanterol at the recommended dose and no evidence of altered protein binding between patients with severe renal impairment and healthy volunteers.
Danish: Efter administration af umeclidinium/vilanterol med 2 gange den anbefalede dosis af umeclidinium og den anbefalede dosis af vilanterol, viste patienter med svært nedsat nyrefunktion ingen tegn på øget systemisk eksponering over for hverken umeclidinium eller vilanterol (Cmax og AUC).
English: How to use ANORO ELLIPTA
Danish: Sådan skal du tage Anoro Ellipta
English: If you use more ANORO ELLIPTA than you should
Danish: Hvis du har taget for meget Anoro Ellipta
English: Placebo (N = 280) ANORO ELLIPTA (N =
Danish: Placebo (N=280) Anoro Ellipta (N=413) versus umeclidinium 55 mikrogram (N=418) Anoro Ellipta (N=413) versus vilanterol 22 mikrogram (N=421)
English: PC:
Danish: PC SN NN
English: versus
Danish: Øjne
English: The total treatment period was 17 weeks.
Danish: Den totale behandlingsperiode var 17 uger.
English: How much to take
Danish: Hvor meget skal der tages
English: The available data are insufficient to reach any conclusions.
Danish: De tilgængelige data er utilstrækkelige til at nå til nogen konklusion.
English: Decreased appetite Increased appetite
Danish: Nedsat appetit Øget appetit
English: After first opening: 90 days.
Danish: Efter første åbning: 90 dage.
English: The safety and effectiveness are not yet known in this age group.
Danish: Sikkerhed og virkning er endnu ikke kendt for denne aldersgruppe.
English: Oral suspension White to off-white suspension
Danish: Oral suspension Hvid til off-white suspension
English: Date of first authorisation: 23/07/2012 Date of latest renewal: 6 April 2017
Danish: Dato for første markedsføringstilladelse: 23/07/2012 Dato for seneste fornyelse: 6. April 2017
English: Study drug was given once per day.
Danish: Studielægemidlet blev givet én gang dagligt.
English: If you have any suspension left in the bottle more than 90 days after it was first opened, you should not use it.
Danish: Hvis der er suspension tilbage i flasken mere end 90 dage efter, den først blev åbnet, må du ikke bruge det.
English: It may take a few weeks to find the right dose of Fycompa for you.
Danish: Det kan tage et par uger at finde frem til den rette dosis Fycompa til dig.
English: Elderly (65 years of age and above)
Danish: Ældre (fra 65 år)
English: Speak to your doctor before drinking alcohol.
Danish: Tal med lægen før du drikker alkohol.
English: It may also cause you to have unusual or extreme changes in behaviour or mood.
Danish: Det kan også forårsage, at du får usædvanlige eller ekstreme ændringer i din adfærd eller dit humør.
English: The results in these adolescents were similar to those seen in the adult population.
Danish: Resultaterne hos disse unge var sammenlignelige med de resultater, der blev set hos den voksne population.
English: EXP After first opening: use within 90 days.
Danish: EXP Efter første åbning: anvendes inden for 90 dage.
English: The cap fits properly when the PIBA is in place.
Danish: Låget passer korrekt, når PIBA er på plads.
English: - Fycompa may make you aggressive, angry or violent.
Danish: - Fycompa kan gøre dig aggressiv, vred eller voldelig.
English: Levels peaked at one hour and were 3.65 times the levels in plasma.
Danish: Niveauerne nåede et maksimum efter en time og var 3,65 gange niveauet i plasma.
English: 35% increase
Danish: 35 % forhøjelse
English: This was not statistically significant (p = 0.96).
Danish: Dette var ikke statistisk signifikant (p = 0,96).
English: It may be taken with or without food, but preferably always under the same conditions.
Danish: Det kan tages sammen med eller uden mad, men fortrinsvis altid under de samme betingelser.
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for perampanel.
Danish: Mekanismen for denne risiko er ukendt, og tilgængelige data ekskluderer ikke muligheden for en forøget risiko med perampanel.