FrancophonIA/ELRC3.0 huggingface dataset:
English: CONDITIONS OF THE MARKETING AUTHORISATION The conditions considered essential for the safe and effective use of the Ropirinole are the following Post-Authorisation Commitment requested by the CHMP and to be submitted to the Reference Member State in the timeline are detailed below:
Danish: Det nævnte post-marketing commitment er krævet af CHMP og skal inden for den givne tidsfrist indsendes til referencemedlemsstaten:
English: If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist as soon as possible.
Danish: Hvis en bivirkning bliver alvorlig eller du bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør du fortælle det til din læge eller apotek.
English: Patients being treated with ropinirole and presenting with somnolence and/or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until such effects have resolved (see also Section 4.4).
Danish: Patienter i behandling med ropinirol og som har oplevet somnolens og/eller episoder med pludselig falden i søvn, skal oplyses om, at de skal undlade at føre motorkøretøj og undgå at deltage i aktiviteter (f.eks. betjening af maskiner), hvor nedsat opmærksomhed kan bringe deres eget eller andres liv og helbred i fare.
English: Always take ADARTREL exactly as your doctor has told you.
Danish: Adartrel bør altid tages i nøje overensstemmelse med din læges instruktioner.
English: Take special care with ADARTREL
Danish: Vær særlig forsigtig med at anvende Adartrel:
English: ADARTREL can cause excessive daytime somnolence (excessive drowsiness) and very rarely sudden sleep onset episodes where patients fall asleep suddenly without apparently feeling sleepy.
Danish: Adartrel kan give overvældende søvnighed i løbet af dagen, og meget sjældent kan dette føre til at du pludselig falder i søvn uden forudgående varsel.
English: The average dose in clinical trials, in patients with moderate to severe Restless Legs Syndrome, was 2 mg once a day.
Danish: Middeldosis i kliniske forsøg var 2 mg en gang daglig for patienter med moderat til svær Restless Legs Syndrome.
English: However, ADARTREL can cause extreme sleepiness (somnolence) and sudden sleep onset episodes.
Danish: Adartrel kan give ekstrem søvnighed og risiko for pludselig at falde i søvn uden varsel.
English: After two days your doctor will probably increase your dose to 0.5 mg once daily for the remainder of your first week of treatment.
Danish: Efter to dage kan lægen øge dosis til 0,5 mg en gang dagligt i resten af den første uge.
English: Then your doctor may increase your dose by 0.5mg per week over three weeks to a dose of 2mg per day.
Danish: Derefter kan lægen fortsætte med at øge dosis gradvist med 0,5mg pr uge over 3 uger op til en dosis på 2 mg pr dag.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
Danish: Til oralt brug ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN Opbevares utilgængeligt for børn.
English: A recent study has been conducted by the MAH in healthy volunteers on the effects of ropinirole on cardiac conduction.
Danish: Markedsføringsindehaveren har for nylig foretaget en undersøgelse af ropinirols effekt på den kardiale overledning.
English: Following ropinirole therapy, postural hypotension or hypotension has been reported uncommonly (>1/1,000, <1/100), rarely severe.
Danish: Ikke almindeligt (>1/1000 og <1/100) er der i forbindelse med ropinirolbehandling rapporteret postural hypotension eller hypotension, sjældent i svær grad.
English: The use of ADARTREL during pregnancy is not recommended.
Danish: Du må ikke tage Adartrel, hvis du er gravid.
English: Domperidone antagonises the dopaminergic actions of ropinirole peripherally and does not cross the blood-brain barrier.
Danish: Domperidon antagoniserer perifert den dopaminerge virkning af ropinirol og passerer ikke blodhjernebarrieren, hvorfor det anvendes som antiemeticum hos patienter behandlet med centralt virkende dopaminagonister.
English: The exact dose of ADARTREL people take can be different.
Danish: Den præcise dosis Adartrel man skal tage, varierer fra patient til patient.
English: Dose (mg)/once daily 1 * To achieve optimal improvement in some patients.
Danish: * For at opnå optimal bedring i nogle patienter
English: Pharmacotherapeutic group: Dopamine agonist, ATC code: N04BC04.
Danish: ATC-kode: N04BC04
English: SmithKline Beecham Pharmaceuticals, Manor Royal, Crawley, West Sussex RH10 9QJ, United Kingdom
Danish: West Sussex RH10 9QJ, United Kingdom
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Danish: Da tabletterne indeholder laktose, bør produktet ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af heriditær lactasemangel (Lapp Lactase deficiency) eller glucose / galactose malabsorption.
English: Do not store above 25 °C.
Danish: Må ikke opbevares ved over 25◦C.
English: - If you have any further questions, ask your doctor or your pharmacist.
Danish: Spørg din læge eller apotek, hvis du har yderligere spørgsmål.
English: Do not chew the tablet(s).
Danish: Tyg ikke tabletterne.
English: Syncope, somnolence, dizziness (including vertigo)
Danish: Synkope, somnolens, svimmelhed (inklusiv vertigo) 4.8.1.1.1.3 Vaskulære lidelser
English: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate
Danish: Tabletkerne: Lactose monohydrat, mikrokrystallinsk cellulose, natrium croscarmellose,
English: GENERAL CLASSIFICATION FOR SUPPLY {To be completed nationally} 15.
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING <[Udfyldes nationalt]>
English: Pink oval-shaped, marked "GS" on one side and "GYG" on the other.
Danish: Lyserød oval tablet mærket ”GS” på den ene side og ”GYG” på den anden.
English: ADARTREL should only be used during pregnancy after your doctor has considered the benefit to you and the potential risk of harm to your unborn child. Tell your doctor immediately if you are pregnant, you think you might be or are planning to become pregnant.
Danish: Adartrel må kun bruges under graviditet hvis lægen har vurderet den gavn du kan have af det og den potentielle risiko som fosteret udsættes for.
English: No dosage adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance between 30 and 50 ml/min).
Danish: Hos patienter med mild til moderat nedsat nyrefunktion (kreatininclearance mellem 30 og 50 ml/min) er dosisjustering ikke nødvendig.
English: ADARTREL 1 mg film-coated tablets
Danish: Adartrel 1 mg filmovertrukne tabletter
English: Smoking is known to induce CYP1A2 metabolism, therefore if patients stop or start smoking during treatment with ropinirole, dose adjustment maybe required.
Danish: Hvis patienter holder op eller starter på at ryge under behandling med ropinirol, kan dosisjustering være nødvendig.
English: Vomiting, abdominal pain, heartburn General disorders and administration site conditions Common
Danish: Opkastning, abdominalsmerter, halsbrand 4.8.1.1.1.9 Generelle symptomer og forstyrrelser ved applikationssted Almindelig
English: 7 MARKETING AUTHORISATION HOLDER Laboratoire GlaxoSmithKline 100, route de Versailles
Danish: 7 INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Laboratoire GlaxoSmithKline
English: Dose reduction should be considered if patients experience significant undesirable effects.
Danish: Hvis patienten oplever betydelige bivirkninger bør dosisreduktion overvejes.
English: Population-related characteristics
Danish: Patientkarakteristika
English: ADARTREL 0.25 mg film-coated tablets
Danish: Adartrel 0,25 mg filmovertrukne tabletter
English: Undesirable effects were normally mild to moderate and experienced at the start of therapy or on increase of dose and few patients withdrew from the clinical studies due to undesirable effects.
Danish: Bivirkningerne var milde til moderate og forbigående eller kom ved øgning af dosis.
English: ADARTREL 2 mg film-coated tablets
Danish: Adartrel 2 mg filmovertrukne tabletter
English: Take special care with ADARTREL Tell your doctor before you start to take this medicine if you:
Danish: Inden du begynder at tage medicinen, så fortæl lægen lægen, hvis du:
English: White oval-shaped, marked "GS" on one side and "MLE" on the other.
Danish: Hvid oval tablet mærket ”GS” på den ene side og ”MLE” på den anden.
English: Titanium dioxide (E171) Iron oxide yellow (E172) Indigo carmine aluminium lake (E132).
Danish: Jernoxid rød (E172) Indigocarmin (E132)
English: Yellow oval-shaped, marked "GS" on one side and "TES" on the other.
Danish: Gul oval tablet mærket ”GS” på den ene side og ”TES” på den anden.
English: 8 MARKETING AUTHORISATION NUMBER(S)
Danish: 8 MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) <[Udfyldes nationalt]>
English: Taking ADARTREL with food may decrease the occurrence of nausea (feeling sick) which is a possible side effect of ADARTREL.
Danish: Kvalme er en mulig bivirkning ved Adartrel.
English: If you are unsure, it is essential that you talk to your doctor.
Danish: Hvis du er i tvivl, så spørg lægen.
English: ADARTREL 1 mg film-coated tablets Ropinirole (as hydrochloride)
Danish: Adartrel 1 mg filmovertrukne tabletter Ropinirol (som hydrochlorid)
English: 6.5 Nature and contents of container PVC/PCTFE/Aluminium blister.
Danish: Opbevares i den originale emballage 6.5 Emballage (art og indhold) PVC/PCTFE/Aluminium blister med 28 eller 84 tabletter Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: hypromellose, macrogol 400, titanium dioxide (E171), polysorbate 80 (E433).
Danish: Filmovertræk: Hypromellose, macrogol 400, titandioxid (E171), polysorbat 80 (E433) Produktets udseende og pakningstørrelse
English: ADARTREL 0.5 mg film-coated tablets
Danish: Adartrel 0,5 mg filmovertrukne tabletter
English: Ropinirole should not be used in nursing mothers as it may inhibit lactation.
Danish: Ropinirol bør ikke anvendes i ammeperioden.
English: Tell your doctor if: - you are already receiving any other medicines for Restless Legs Syndrome.
Danish: • du får anden medicin for Restless Legs Syndrome
English: 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Dopamine agonist, ATC code: N04BC04.
Danish: Farmakoterapeutisk klassifikation: Dopaminagonist.
English: ADARTREL 2 mg film-coated tablets Ropinirole (as hydrochloride)
Danish: Adartrel 2 mg filmovertrukne tabletter Ropinirol (som hydrochlorid)
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Kontakt lægen før du tager denne medicin, hvis lægen har fortalt dig at du ikke tåler visse sukkerarter.
English: - have liver disease - have a serious heart complaint - have a serious mental health problem In these situations your doctor should carefully supervise the treatment.
Danish: - du ammer - er overfølsom over for visse sukkerarter (f.eks. lactose) - har en leversygdom - hvis du har alvorlige hjerteproblemer - hvis du har eller har haft en alvorlig mental sygdom I disse tilfælde skal lægen overvåge behandlingen omhyggeligt.
English: Each film-coated tablet contains 1 mg of ropinirole (as hydrochloride).
Danish: Hver filmovertrukket tablet indeholder 1 mg af ropinirol (som hydrochlorid).
English: Green oval-shaped, marked "GS" on one side and "SJG" on the other.
Danish: Grøn oval tablet mærket ”GS” på den ene side og ”SJG” på den anden.
English: NAME OF THE MEDICINAL PRODUCT ADARTREL 0.25 mg film-coated tablets Ropinirole NAME OF THE MARKETING AUTHORISATION HOLDER Laboratoire GlaxoSmithKline {See Annex I- to be completed nationally} EXPIRY DATE exp {MM YYYY} BATCH NUMBER lot {XYYYY} OTHER
Danish: LÆGEMIDLETS NAVN Adartrel 0,25 mg filmovertrukne tabletter Ropinirol NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Laboratoire GlaxoSmithKline <[Se bilag I - Udfyldes nationalt]> UDLØBSDATO exp {MM YYYY} BATCHNUMMER lot {XYYYY} ANDET
English: NAME OF THE MEDICINAL PRODUCT ADARTREL 1 mg film-coated tablets Ropinirole NAME OF THE MARKETING AUTHORISATION HOLDER Laboratoire GlaxoSmithKline {See Annex I- to be completed nationally} EXPIRY DATE exp {MM YYYY} BATCH NUMBER lot {XYYYY} OTHER
Danish: LÆGEMIDLETS NAVN Adartrel 1 mg filmovertrukne tabletter Ropinirol NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Laboratoire GlaxoSmithKline <[Se bilag I - Udfyldes nationalt]> UDLØBSDATO exp {MM YYYY} BATCHNUMMER lot {XYYYY} ANDET
English: Each film-coated tablet contains 2 mg of ropinirole (as hydrochloride).
Danish: Hver filmovertrukket tablet indeholder 2 mg af ropinirol (som hydrochlorid).
English: Take special care with ADARTREL Tell your doctor before you start to take this medicine if you: - are pregnant or think you are pregnant - are breast-feeding - are intolerant to some sugars (e.g. lactose)
Danish: Inden du begynder at tage medicinen, så fortæl lægen lægen, hvis du: - er gravid eller tror du er gravid
English: NAME OF THE MEDICINAL PRODUCT ADARTREL 0.5 mg film-coated tablets Ropinirole NAME OF THE MARKETING AUTHORISATION HOLDER Laboratoire GlaxoSmithKline {See Annex I- to be completed nationally} EXPIRY DATE exp {MM YYYY} BATCH NUMBER lot {XYYYY} OTHER
Danish: LÆGEMIDLETS NAVN Adartrel 0,5 mg filmovertrukne tabletter Ropinirol NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Laboratoire GlaxoSmithKline <[Se bilag I - Udfyldes nationalt]> UDLØBSDATO exp {MM YYYY} BATCHNUMMER lot {XYYYY} ANDET
English: ADARTREL 0.5 mg film-coated tablets Ropinirole (as hydrochloride)
Danish: Adartrel 0,5 mg filmovertrukne tabletter Ropinirol (som hydrochlorid)
English: Each film-coated tablet contains 0.5 mg of ropinirole (as hydrochloride).
Danish: Hver filmovertrukket tablet indeholder 0,5 mg af ropinirol (som hydrochlorid).
English: Each film-coated tablet contains 0.25 mg of ropinirole (as hydrochloride).
Danish: Hver filmovertrukket tablet indeholder 0,25 mg af ropinirol (som hydrochlorid).
English: hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172).
Danish: Filmovertræk: Hypromellose, macrogol 400, titandioxid (E171), jernoxid gul (E172), jernoxid rød
English: ADARTREL 0.25 mg film-coated tablets Ropinirole (as hydrochloride)
Danish: Adartrel 0,25 mg filmovertrukne tabletter Ropinirol (som hydrochlorid)
English: If you take more ADARTREL than you should or if someone else has taken your medicine, tell a doctor or pharmacist immediately.
Danish: Kontakt lægen, skadestuen eller apoteket, hvis du har taget mere Adartrel end der står i denne vejledning eller mere end lægen har foreskrevet, eller hvis en anden har taget medicinen.
English: Marketing authorisation Holder
Danish: Indehaver af markedsføringstill delse
English: Invented name Strengths
Danish: Særnavn
English: BATCH NUMBER {To be completed nationally} 14.
Danish: FREMSTILLERENS BATCHNUMMER <[Udfyldes nationalt]>
English: PVC/PCTFE/Aluminium blister.
Danish: PVC/PCTFE/Aluminium blister med 28 eller 84 tabletter Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172).
Danish: Titandioxid (E171)
English: Abdominal pain
Danish: Lactose monohydrat
English: Tablet core:
Danish: Tabel 1: Dosistitrering
English: The side effects are generally mild and may become less after you have taken the medicine for a short time.
Danish: Bivirkningerne er generelt milde og forbigående.
English: hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172), indigo carmine aluminium lake (E132).
Danish: Filmovertræk: Hypromellose, macrogol 400, titandioxid (E171), jernoxid gul (E172),
English: Metabolism
Danish: Tabletkerner
English: hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), indigo carmine aluminium lake (E132).
Danish: - De øvrige indholdsstoffer er Tabletkerne: Lactose monohydrat, mikrokrystallinsk cellulose, natrium croscarmellose, magnesiumstearat Filmovertræk: Hypromellose, macrogol 400, titandioxid (E171), jernoxid gul (E172), jernoxid rød (E172).
English: The most common side effects are: - feeling or being sick - dizziness (or spinning sensation) - feeling drowsy - fatigue (mental or physical tiredness) - stomach pain - fainting - nervousness
Danish: • træthed (mental eller fysisk træthed)
English: These medicines include: - ciprofloxacin (an antibiotic) - enoxacin (an antibiotic) - fluvoxamine (a drug used to treat depression) - theophylline (a drug used to treat asthma) - hormone replacement therapy (also called HRT) - anti-psychotics and other drugs that block dopamine in the brain (e.g. sulpiride or metoclopramide)
Danish: • antipsykotika og andre lægemidler som blokerer dopamin i hjernen (for eksempel sulpirid eller metoklopramid)
English: You have not received enough of your medicine.
Danish: Du har ikke fået tilstrækkeligt meget af din medicin.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Danish: Tag ikke lægemidlet efter den udløbsdato, der står på pakningen og blisteren efter ”Udløbsdato”/”EXP”.
English: There is no relevant use of Xoterna Breezhaler in the paediatric population (under 18 years) in the indication COPD.
Danish: Der er ingen relevant brug af Xoterna Breezhaler i den pædiatriske population (under 18 år) ved indikationen KOL.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Post-dose trough FEV1 (least squares mean) at day 1 and week 26 (primary endpoint)
Danish: Postdosis dal FEV1 (least squares gennemsnit) ved dag 1 og uge 26 (primært endepunkt)
English: Other most common adverse reactions related to the medicinal product (at least 3% of patients for Xoterna Breezhaler and also greater than placebo) were cough, nasopharyngitis and headache.
Danish: Øvrige mest almindelige bivirkninger relateret til lægemidlet (mindst 3 % af patienterne på Xoterna Breezhaler og også højere end for placebo) var hoste, nasopfaryngitis og hovedpine.
English: Talk to your doctor, pharmacist or nurse before using Xoterna Breezhaler if any of the following applies to you: - you have asthma - this medicine should not be used as a treatment for asthma.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Xoterna Breezhaler hvis noget af følgende passer på dig: - hvis du har astma - denne medicin må ikke bruges til behandling af astma.
English: Therefore Xoterna Breezhaler should not be given together with beta-adrenergic blockers (including eye drops) unless there are compelling reasons for their use.
Danish: Xoterna Breezhaler bør derfor ikke gives sammen med beta-adrenerge blokkere (herunder øjendråber), medmindre der er tvingende årsager hertil.
English: The presentation of the safety profile is based on the experience with Xoterna Breezhaler and the individual active substances.
Danish: Oplysningerne om sikkerhedsprofilen er baseret på erfaringerne med Xoterna Breezhaler og de individuelle aktive stoffer.
English: The recommended dose is the inhalation of the content of one capsule once daily using the Xoterna Breezhaler inhaler.
Danish: Den anbefalede dosis er inhalation af indholdet i en kapsel én gang dagligt ved hjælp af Xoterna Breezhaler-inhalatoren.
English: The effect was significantly greater for Xoterna Breezhaler, when compared to indacaterol, glycopyrronium or tiotropium alone (difference 110 ml, for each comparison).
Danish: Virkningen var signifikant højere for Xoterna Breezhaler sammenlignet med indacaterol, glycopyrronium eller tiotropium alene (forskel på 110 ml for hver sammenligning).
English: Following inhalation of Xoterna Breezhaler, the absolute bioavailability of indacaterol has been estimated to range from 61 to 85% of the delivered dose, and that of glycopyrronium was about 47% of the delivered dose.
Danish: Efter inhalation af Xoterna Breezhaler er den absolutte biotilgængelighed af indacaterol blevet estimeret til at være fra 61 til 85 % af leveret dosis, og for glycopyrronium var den omkring 47 % af leveret dosis.
English: Novartis Pharma GmbH Roonstraße 25
Danish: Novartis Pharma GmbH Roonstrasse 25
English: Administration of Xoterna Breezhaler may result in paradoxical bronchospasm which can be life-threatening.
Danish: Anvendelse af Xoterna Breezhaler kan medføre paradoks bronkospasme, hvilket kan være livstruende.
English: Xoterna Breezhaler should not be used for the treatment of asthma due to the absence of data in this indication.
Danish: Xoterna Breezhaler må ikke anvendes til behandling af astma, da der ikke foreligger data for denne indikation.
English: Do not use Xoterna Breezhaler - if you are allergic to indacaterol or glycopyrronium or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Xoterna Breezhaler - hvis du er allergisk over for indacaterol eller glycopyrronium eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: The components of Xoterna Breezhaler are not known to have a QT-prolongation potential at clinical dose levels.
Danish: Komponenterne i Xoterna Breezhaler er ikke kendt for at have et QT-forlængende potentiale ved kliniske dosisniveauer.
English: - The other ingredients of the inhalation powder are lactose monohydrate and magnesium stearate (see section 2 under “Xoterna Breezhaler contains lactose”).
Danish: - Øvrige indholdsstoffer i inhalationspulveret: lactosemonohydrat og magnesiumstearat(se afsnit 2 under ”Xoterna Breezhaler indeholder lactose”).
English: Xoterna Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older).
Danish: Xoterna Breezhaler kan bruges ved den anbefalede dosis til ældre patienter (75 år eller ældre).
English: During long-term clinical studies, more patients on Xoterna Breezhaler experienced clinically notable changes in blood glucose (4.9%) at the recommended dose than on placebo (2.7%).
Danish: Kliniske langtidsstudier har vist, at flere patienter på Xoterna Breezhaler har oplevet klinisk betydningsfulde ændringer i blodglukose (4,9 %) ved den anbefalede dosis end ved placebo (2,7 %).
English: In particular, please tell your doctor or pharmacist if you are using: - any medicines that may be similar to Xoterna Breezhaler (contain similar active substances).
Danish: Fortæl det især til lægen, hvis du tager: medicin som kan være tilsvarende Xoterna Breezhaler (indeholder lignende aktive stoffer).
English: Indacaterol administered to dogs alone or in Xoterna Breezhaler was associated with a similar incidence and severity of myocardial lesions.
Danish: Indacaterol administreret til hunde alene eller i Xoterna Breezhaler var forbundet med sammenlignelig forekomst og sværhedsgrad af myokardielæsioner.
English: What Xoterna Breezhaler contains - The active substances are indacaterol (as maleate) and glycopyrronium bromide.
Danish: Xoterna Breezhaler indeholder - Aktive stoffer: indacaterol (som maleat) og glycopyrroniumbromid.
English: Xoterna Breezhaler should be used with caution in these patient groups.
Danish: Xoterna Breezhaler bør anvendes med forsigtighed til disse patientgrupper.
English: No specific interaction studies were conducted with Xoterna Breezhaler.
Danish: Der er ikke udført specifikke interaktionsstudier med Xoterna Breezhaler.