FrancophonIA/ELRC3.0 huggingface dataset:
English: An approximately 1.3-fold increase in umeclidinium bromide AUC was observed at an 8-fold higher dose with no effect on umeclidinium bromide Cmax.
Danish: AUC for umeclidiniumbromid blev øget ca. 1,3 gange ved en 8 gange højere dosis, uden at der blev set nogen effekt på Cmax for umeclidiniumbromid.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland GlaxoSmithKline (Ireland) Limited logo
Danish: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Irland GlaxoSmithKline (Ireland) Limited logo
English: Incruse Ellipta has not been studied in patients with severe hepatic impairment and should be used with caution (see section 5.2).
Danish: Anvendelse af Incruse Ellipta er ikke undersøgt hos patienter med svært nedsat leverfunktion og skal derfor anvendes med forsigtighed til disse patienter (se pkt.
English: If you are breast-feeding, you must check with your doctor before you use Incruse Ellipta.
Danish: Hvis du ammer, skal du tale med lægen, før du begynder at tage Incruse Ellipta.
English: Toxicity to reproduction
Danish: Reproduktionstoksicitet
English: What Incruse Ellipta contains The active substance is umeclidinium bromide.
Danish: Incruse Ellipta indeholder det aktive stof umeclidiniumbromid.
English: Multipack: 90 (3 packs of 30) doses
Danish: Inhalationspulver, afdelt Multipakning: 90 (3 pakninger med 30) doser
English: Magyarország GlaxoSmithKline Kft. Tel.: + 36 1 225 5300
Danish: GlaxoSmithKline Kft. Tel.: + 36 1 225 5300
English: LIST OF EXCIPIENTS Excipients: lactose and magnesium stearate.
Danish: Hjælpestoffer: lactose og magnesiumstearat.
English: The clinical efficacy of Incruse Ellipta administered once daily was evaluated in 904 adult patients who received umeclidinium bromide or placebo from two pivotal Phase III clinical studies with a clinical diagnosis of COPD; a 12-week study (AC4115408) and a 24-week study (DB2113373).
Danish: Den kliniske virkning af Incruse Ellipta administreret én gang daglig blev vurderet i to pivotale kliniske fase III-studier, hvor 904 voksne patienter med en klinisk diagnose på KOL fik umeclidiniumbromid eller placebo; et studie var af 12 ugers varighed (AC4115408) og et studie af 24 ugers varighed (DB2113373).
English: • Put the mouthpiece between your lips, and close your lips firmly around it. Don't block the air vent with your fingers.
Danish: • Placér mundstykket mellem læberne, og luk læberne godt sammen omkring mundstykket.
English: In the 24-week placebo-controlled study in patients with symptomatic COPD, Incruse Ellipta reduced the risk of a moderate/severe COPD exacerbation by 40% compared with placebo (analysis of time to first exacerbation; Hazard Ratio 0.6; 95% CI: 0.4, 1.0, p=0.035*).
Danish: I det 24 ugers placebokontrollerede studie hos patienter med symptomatisk KOL, reducerede Incruse Ellipta risikoen for moderat/svær KOL-eksacerbation med 40% sammenlignet med placebo (analyse af tiden til første eksacerbation; hazard ratio 0,6; 95% CI: 0,4, 1,0, p = 0,035*).
English: Sími: + 354 535 7000
Danish: Vistor hf. Sími: + 354 535 7000
English: The medicinal product may not be tasted or felt, even when using the inhaler correctly.
Danish: Det er ikke sikkert, at medicinen kan smages eller mærkes, selvom inhalatoren anvendes korrekt.
English: 1.least squares mean (95% confidence interval)
Danish: 1Middelværdi udregnet med mindste kvadraters metode (95 % konfidensinterval).
English: Infections and infestations Nasopharyngitis Upper respiratory tract infection Urinary tract infection
Danish: Nasopharyngitis Infektion i øvre luftveje Urinvejsinfektion Sinuitis
English: In a Phase III, 6-month study (DB2113373) Incruse Ellipta provided a clinically meaningful improvement over placebo in lung function (as measured by forced expiratory volume in 1 second [FEV1]) over 24 hours following once daily administration, which was evident at 30 minutes following administration of the first dose (improvement over placebo by 102 mL, p<0.001*).
Danish: I et fase III-studie af 6 måneders varighed (DB2113373) viste Incruse Ellipta klinisk relevant forbedring af lungefunktionen i forhold til placebo (målt ved forceret eksspiratorisk volumen i første sekund [FEV1]) over 24 timer efter administration én gang daglig, som var tydelig 30 minutter efter administration af den første dosis, med en forbedring på 102 ml (p < 0,001∗) sammenlignet med placebo.
English: In the 12-week study, Incruse Ellipta statistically significantly reduced the use of rescue medication with salbutamol compared with placebo (on average a reduction of 0.7 puffs per day over Weeks 1-12, p=0.025) and demonstrated a higher percentage of days when no rescue medication was needed (on average 46.3%) compared with placebo (on average 35.2%; no formal statistical analysis was performed on this endpoint).
Danish: I studiet af 12 ugers varighed reducerede Incruse Ellipta forbruget af anfaldsmedicin (salbutamol) sammenlignet med placebo (gennemsnitligt en reduktion på 0,7 pust pr. dag over uge 1-12, p = 0,025), og der blev set en højere procentdel af dage uden behov for anfaldsmedicin (gennemsnitligt 46,3 %) sammenlignet med placebo (gennemsnitligt 35,2 % - der blev ikke foretaget nogen formel statistisk analyse på dette endepunkt).
English: Don't use Incruse Ellipta as well as these other medicines.
Danish: Du må ikke tage Incruse Ellipta, hvis du allerede tager nogen af disse lægemidler.
English: Slovenská republika GlaxoSmithKline Slovakia s. r. o. Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
Danish: GlaxoSmithKline Slovakia s. r. o. Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
English: Incruse Ellipta contains lactose
Danish: Incruse Ellipta indeholder lactose
English: At Week 52, a statistically significant improvement in the least-squares (LS) mean change from baseline in trough FEV1 was observed for FF/UMEC/VI compared with FF/VI (mean change: +94 mL vs. -3 mL; treatment difference: 97 mL; 95% CI: 85, 109; p<0.001).
Danish: Ved uge 52 blev der observeret en statistisk signifikant forbedring af least-squares (LS) mean change fra baseline i trough-FEV1 for FF/UMEC/VI sammenlignet med FF/VI (gennemsnitlig forskel: +94 ml vs. -3 ml; behandlingsforskel: 97 ml; 95 % CI: 85, 109; p < 0,001).
English: The most frequently reported adverse reactions with Incruse Ellipta were nasopharyngitis and upper respiratory tract infection.
Danish: Sammendrag af sikkerhedsprofilen De hyppigst rapporterede bivirkninger ved Incruse Ellipta var nasopharyngitis og infektion i de øvre luftveje.
English: In two 12-week, placebo controlled studies (200109 and 200110), the addition of Incruse Ellipta to fluticasone furoate/vilanterol (FF/VI) (92/22 micrograms) once daily in adult patients with a clinical diagnosis of COPD, resulted in statistically significant and clinically meaningful improvements in the primary endpoint of trough FEV1 at Day 85 compared to placebo plus FF/VI (124 mL 95% CI: 93, 154; p<0.001and 122 mL 95% CI: 91, 152; p<0.001).
Danish: I to 12-ugers placebokontrollerede studier (200109 og 200110) viste tillæg af Incruse Ellipta til fluticasonfuroat/vilanterol (FF/VI) (92/22 mikrogram) én gang daglig til voksne patienter med en klinisk diagnose af KOL en statistisk signifikant og klinisk relevant forbedring af det primære endepunkt troughFEV1 ved dag 85, sammenlignet med placebo plus FF/VI (124 ml 95 % CI: 93, 154; p < 0,001 og 122 ml 95 % CI: 91, 152; p < 0,001).
English: What you need to know before you use Incruse Ellipta Do not use Incruse Ellipta:
Danish: Det skal du vide, før du begynder at tage Incruse Ellipta Tag ikke Incruse Ellipta
English: Your Incruse Ellipta inhaler carton contains
Danish: Din æske med Incruse Ellipta inhalator indeholder
English: If you stop using Incruse Ellipta
Danish: Hvis du holder op med at tage Incruse Ellipta
English: In both of the pivotal 12-week and 24-week studies, Incruse Ellipta demonstrated statistically significant and clinically meaningful improvements in lung function (as defined by change from baseline trough FEV1 at Week 12 and Week 24 respectively, which was the primary efficacy endpoint in each study) compared with placebo (see Table 1).
Danish: Både i det pivotale studie af 12 ugers varighed og det pivotale studie af 24 ugers varighed viste Incruse Ellipta statistisk signifikante og klinisk relevante forbedringer af lungefunktionen (defineret som ændring i forhold til baseline i trough-FEV1 ved henholdsvis uge 12 og uge 24, hvilket var det primære effektendepunkt i begge studier) sammenlignet med placebo (se tabel 1).
English: 4) Close the inhaler
Danish: 4) Luk inhalatoren
English: Wait to open the cover until you are ready to inhale your dose.
Danish: Vent med at åbne beskyttelseshætten, til du er klar til at inhalere din dosis.
English: How to use Incruse Ellipta 4.
Danish: Sådan skal du tage Incruse Ellipta 4.
English: Intraocular pressure increased
Danish: Øjensmerter Øget intraokulært tryk
English: The proportion of patients who responded with at least the MCID in SGRQ score (defined as a decrease of 4 units from baseline) at Week 12 was greater for Incruse Ellipta 55 micrograms (44%) compared with placebo (26%) in the 12-week study.
Danish: Andelen af patienter, der som minimum responderede med MCID i SGRQ-scoren (defineret som et fald på 4 enheder i forhold til baseline) ved uge 12, var større for Incruse Ellipta 55 mikrogram (44 %) sammenlignet med placebo (26 %) i studiet af 12 ugers varighed.
English: In the 24-week study treatment with Incruse Ellipta, the mean (SD) change from baseline in the number of puffs of rescue salbutamol over the 24-week treatment period was -1.4 (0.20) for placebo and -1.7 (0.16) for Incruse Ellipta (Difference = -0.3; 95% CI: -0.8, 0.2, p=0.276).
Danish: I de 24 ugers forsøgsbehandling med Incruse Ellipta var den gennemsnitlige (SD) ændring i forhold til baseline i antal pust af anfaldsmedicin (salbutamol) over behandlingsperioden på 24 uger -1,4 (0,20) for placebo og -1,7 (0,16) for Incruse Ellipta (forskel = -0,3, 95 % CI: -0,8, 0,2, p = 0,276).
English: Incruse Ellipta also demonstrated a statistically significant improvement in health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ) as indicated by a reduction in SGRQ total score at Week 12 compared with placebo (-7.90 units, p<0.001) in the 12-week study.
Danish: Incruse Ellipta viste desuden en forbedring af den helbredsrelaterede livskvalitet målt ved St. George's Respiratory Questionnaire (SGRQ), indikeret ved en reduktion i den samlede SGRQ-score ved uge 12 sammenlignet med placebo (-7,90 enheder, p < 0,001) i studiet af 12 ugers varighed.
English: Incruse Ellipta is for inhalation use.
Danish: Incruse Ellipta er til inhalationsbrug.
English: INFORMATION IN BRAILLE incruse ellipta
Danish: INFORMATION I BRAILLESKRIFT
English: Incruse Ellipta is for inhalation use only.
Danish: Incruse Ellipta er kun beregnet til inhalation.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not use this medicinal product.
Danish: Dette lægemiddel indeholder lactose og bør ikke anvendes til patienter med hereditær galactoseintolerans, total lactasemangel eller glucose-/galactosemalabsorption.
English: United Kingdom GlaxoSmithKline UK Ltd Tel: + 44 (0)800 221441 customercontactuk@gsk.com
Danish: GlaxoSmithKline UK Ltd Tel: + 44 (0)800 221441 customercontactuk@gsk.com
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 7 doses
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ENHEDER
English: Similarly, a greater proportion of patients achieved 1 unit TDI focal score for Incruse Ellipta (53%) compared with placebo (41%) at Week 24 in the 24-week study.
Danish: Ligeledes opnåede en større andel af patienterne ≥ 1 enhed i TDI fokal score for Incruse Ellipta (53 %) sammenlignet med placebo (41 %) ved uge 24 i studiet af 24 ugers varighed.
English: What is the inhaler?
Danish: Brugervejledning Hvad er en inhalator?
English: These may affect up to 1 in 1,000 people:
Danish: Kan forekomme hos op til 1 ud af 100 personer:
English: In the 12-week study, a statistically significant improvement compared with placebo in the TDI focal score at Week 12 was not demonstrated for Incruse Ellipta (1.0 units, p=0.05).
Danish: I studiet af 12 ugers varighed blev der ikke påvist en statistisk signifikant forbedring sammenlignet med placebo i TDI fokal score ved uge 12 for Incruse Ellipta (1,0 enheder, p = 0,05).
English: Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v.
Danish: GlaxoSmithKline Pharmaceuticals s.a./n.v.
English: Magnesium stearate
Danish: Lactosemonohydrat Magnesiumstearat
English: The proportion of patients who responded with at least the minimum clinically important difference (MCID) of 1 unit TDI focal score at Week 12 was greater for Incruse Ellipta (38%) compared with placebo (15%) in the 12-week study.
Danish: Andelen af patienter, der som minimum responderede med mindste klinisk relevante ændring (MCID) på 1 enhed i TDI fokal score ved uge 12, var større for Incruse Ellipta (38 %) sammenlignet med placebo (15 %) i studiet af 12 ugers varighed.
English: Similarly, a greater proportion of patients achieved at least the MCID for Incruse Ellipta at Week 24 (44%) compared with placebo (34%) in the 24-week study.
Danish: Ligeledes opnåede en større andel af patienterne som minimum MCID for Incruse Ellipta ved uge 24 (44 %) sammenlignet med placebo (34 %) i studiet af 24 ugers varighed.
English: If you open and close the cover without inhaling the medicine, you will lose the dose.
Danish: 1) Læs dette, inden du starter Hvis du åbner og lukker beskyttelseshætten, uden at inhalere medicinen, så vil dosis gå tabt.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 April 2014
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: EU/1/14/922/002
Danish: EU/1/14/922/001 EU/1/14/922/002
English: How to use the inhaler See ‘Step-by-step instructions for use' in this leaflet for full information.
Danish: Se 'Brugervejledning' i denne indlægsseddel for yderligere oplysninger.
English: Incruse Ellipta demonstrated a statistically significant greater improvement from baseline in weighted mean FEV1 over 0-6 hours post-dose at Week 12 compared with placebo (166 ml, p<0.001) in the 12week pivotal study.
Danish: Incruse Ellipta viste en statistisk signifikant større forbedring i forhold til baseline i vægtet middelværdi for FEV1 over 0-6 timer efter dosering ved uge 12 sammenlignet med placebo (166 ml, p < 0,001) i det pivotale studie af 12 ugers varighed.
English: Common Uncommon Not Known
Danish: Almindelig Ikke almindelig Ikke kendt
English: Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com
Danish: GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com
English: Other medicines and Incruse Ellipta
Danish: Brug af anden medicin sammen med Incruse Ellipta
English: A statistically significant improvement compared with placebo in the TDI focal score at Week 24 was demonstrated for Incruse Ellipta (1.0 units, p<0.001) in the 24-week study.
Danish: Der blev påvist en statistisk signifikant forbedring sammenlignet med placebo i TDI fokal score ved uge 24 for Incruse Ellipta (1,0 enheder, p < 0,001) i studiet af 24 ugers varighed.
English: Versus Placebo mcg = micrograms
Danish: Versus placebo
English: Don't inhale an extra dose to make up for a forgotten dose.
Danish: Hvis du har glemt at tage Incruse Ellipta Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: NAME OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline (Ireland) Limited logo
Danish: GlaxoSmithKline (Ireland) Limited logo
English: In-use shelf-life after opening the tray: 6 weeks.
Danish: 2 år Holdbarhed efter anbrud af bakken: 6 uger.
English: NAME OF THE MEDICINAL PRODUCT Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed
Danish: Incruse Ellipta 55 mikrogram inhalationspulver, afdelt
English: No new adverse drug reactions were identified with the addition of Incruse Ellipta to FF/VI in these studies.
Danish: Tillæg af Incruse Ellipta til FF/VI i disse studier resulterede ikke i identifikation af nye bivirkninger.
English: • While holding the inhaler away from your mouth, breathe out as far as is comfortable.
Danish: 3) Inhalér din medicin • Hold inhalatoren væk fra munden, og foretag den dybeste udånding, du finder behagelig.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations) Priory Street
Danish: Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations) Priory Street
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide).
Danish: Hver afgivet dosis indeholder 55 mikrogram umeclidinium (svarende til 65 mikrogram umeclidiniumbromid).
English: s.a./n.v.
Danish: PC SN NN
English: Incruse Ellipta demonstrated a greater improvement from baseline in weighted mean FEV1 over 0-6 hours post-dose at Week 24 compared with placebo (150 ml, p<0.001
Danish: Incruse Ellipta viste en større forbedring i forhold til baseline i vægtet middelværdi for FEV1 over 0-6 timer efter dosering ved uge 24 sammenlignet med placebo (150 ml, p<0,001∗) i det pivotale studie af 24 ugers varighed.
English: Talk to your doctor before using this medicine: if you have asthma (Don't use Incruse Ellipta to treat asthma) if you have heart problems if you have an eye problem called narrow-angle glaucoma if you have an enlarged prostate, difficulty passing urine or a blockage in your bladder if you have severe liver problems
Danish: Kontakt lægen, før du tager dette lægemiddel: - hvis du har astma (brug ikke Incruse Ellipta til behandling af astma)
English: METHOD AND ROUTE(S) OF ADMINISTRATION Once daily
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E)
English: What Incruse Ellipta is
Danish: incruse ellipta
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 Incruse Ellipta, da du kan have brug for lægehjælp.
English: Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed umeclidinium (umeclidinium bromide)
Danish: Incruse Ellipta 55 mikrogram inhalationspulver, afdelt umeclidinium (umeclidiniumbromid)
English: Lactose monohydrate
Danish: Forstoppelse Mundtørhed
English: How to use Incruse Ellipta
Danish: Sådan skal du tage Incruse Ellipta
English: A greater improvement compared with placebo in the change from baseline in SGRQ total score at Week 24 was demonstrated for Incruse Ellipta (-4.69 units, p<0.001) in the 24-week study.
Danish: I studiet af 24 ugers varighed viste Incruse Ellipta en større forbedring sammenlignet med placebo i ændring i forhold til baseline af den samlede SRGQ-score ved uge 24 (-4,69 enheder, p < 0,001∗).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each single inhalation provides a delivered dose (the dose leaving the mouthpiece of the inhaler) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) This corresponds to a pre-dispensed dose of 62.5 micrograms umeclidinium equivalent to 74.2 micrograms umeclidinium bromide.
Danish: Hver enkelt inhalation leverer en afgivet dosis (den dosis, der forlader inhalatorens mundstykke) på 55 mikrogram umeclidinium (umeclidinium) (svarende til 65 mikrogram umeclidiniumbromid (umeclidinii bromidum)).
English: If you forget to use Incruse Ellipta
Danish: Hvis du har taget for meget Incruse Ellipta
English: NAME OF THE MEDICINAL PRODUCT Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed umeclidinium (umeclidinium bromide)
Danish: Indlægsseddel: Information til brugeren Incruse Ellipta 55 mikrogram inhalationspulver, afdelt umeclidinium (umeclidiniumbromid) umeclidinium (umeclidinii bromidum)
English: • skin rash (hives) or redness
Danish: • udslæt (nældefeber) eller rødme.
English: This medicinal product contains lactose.
Danish: Lægemidlet er receptpligtigt.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Danish: BILAG II A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: The Ellipta inhaler consists of a grey body, light green mouthpiece cover and a dose counter, packed into a foil laminate tray containing a silica gel desiccant sachet.
Danish: Den er pakket i en bakke af laminatfolie, der indeholder silica-gel tørrepose.
English: Tel: + 370 5 264 90 00 info.lt@gsk.com
Danish: GlaxoSmithKline Lietuva UAB Tel: + 370 5 264 90 00 info.lt@gsk.com
English: NAME OF THE MEDICINAL PRODUCT Incruse Ellipta 55 mcg inhalation powder umeclidinium (umeclidinium bromide)
Danish: Incruse Ellipta 55 mikrog inhalationspulver umeclidinium (umeclidiniumbromid)
English: What Incruse Ellipta looks like and contents of the pack Incruse Ellipta is an inhalation powder, pre-dispensed.
Danish: Incruse Ellipta er inhalationspulver, afdelt.
English: The first time you use Incruse Ellipta you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away.
Danish: Det er ikke nødvendigt at kontrollere, om inhalatoren virker korrekt, før du bruger Incruse Ellipta første gang.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL LAMINATE TRAY LID
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP LÅG TIL FOLIELAMINERET BAKKE 55 mikrogram
English: COPD exacerbations
Danish: KOL-eksacerbationer
English: CLINICAL PARTICULARS
Danish: Tørremiddel
English: Close the inhaler
Danish: c) Luk inhalatoren
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/922/003
Danish: EU/1/14/922/001 EU/1/14/922/002 EU/1/14/922/003
English: Suicidal behaviour5,7
Danish: Selvmordsrelateret adfærd5,7
English: 7 Not statistically significantly different from placebo.
Danish: 7Ikke statistisk signifikant forskellig fra placebo.
English: ARICLAIM is indicated in adults.
Danish: ARICLAIM er indiceret til voksne.
English: In patients with inadequate initial response, additional response after this time is unlikely.
Danish: Hos de patienter, som har utilstrækkelig initialt respons, er yderligere respons efter dette tidspunkt usandsynligt.
English: Some patients who stop taking ARICLAIM suddenly have had symptoms such as:
Danish: Nogle patienter, som pludselig holdt op med at tage ARICLAIM, fik symptomer som:
English: 3 See section 4.4.
Danish: 3 Se pkt 4.4.
English: Do not drive or use any tools or machines until you know how ARICLAIM affects you.
Danish: Du må ikke køre bil eller arbejde med værktøj eller maskiner, før du ved, hvordan ARICLAIM påvirker dig.
English: In people with diabetic neuropathic pain it can take some weeks before you feel better.
Danish: Hos de fleste mennesker med diabetiske neuropatiske smerter kan det vare nogle uger, før de får det bedre.
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Danish: Hvis tidsfristen for en PSUR og for opdatering af en RMP er sammenfaldende, kan de fremsendes samtidig
English: To help you remember to take ARICLAIM, you may find it easier to take it at the same times every day.
Danish: Det kan være lettere at huske at tage ARICLAIM, hvis du tager det på samme tidspunkt hver dag.
English: You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Danish: Du kan bede dem om at fortælle det til dig, hvis de synes, din depression eller angstsygdom bliver værre, eller hvis de er bekymrede over ændringer i din adfærd.