FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicine should not be taken at the same time as other medicines that contain efavirenz, emtricitabine or tenofovir disoproxil, or lamivudine (another antiviral medicine).
Danish: Dette lægemiddel må ikke tages samtidig med andre lægemidler, der indeholder efavirenz, emtricitabin, tenofovirdisoproxil eller lamivudin (et andet antiviralt lægemiddel).
English: Because Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: This medicine contains three active substances: efavirenz, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Danish: Lægemidlet indeholder tre aktive stoffer: efavirenz, som er en non-nukleosid revers transkriptasehæmmer (NNRTI), emtricitabin, som er en nukleosid revers transkriptasehæmmer, og tenofovirdisoproxil, som er et "prodrug" (forstadium) til tenofovir, dvs. det omdannes til det aktive stof tenofovir i kroppen.
English: The company that markets the medicine will ensure that all doctors expected to prescribe the medicine are provided with an educational pack that includes information on the increased risk of kidney disease with tenofovir disoproxil-containing medicines such as this one.
Danish: Virksomheden, der markedsfører lægemidlet, vil sikre, at alle læger, som forventes at ordinere lægemidlet, får udleveret informationsmateriale om den øgede risiko for nyresygdom, der er forbundet med lægemidler, som indeholder tenofovirdisoproxil, herunder Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva.
English: This is a summary of the European public assessment report (EPAR) for Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva.
English: For practical information about using Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What is Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva and what is it used for?
Danish: Hvad er Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva, og hvad anvendes det til?
English: For more information about treatment with this medicine, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Other information about Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
Danish: Andre oplysninger om Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
English: Efavirenz / emtricitabine / tenofovir disoproxil
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva efavirenz/emtricitabin/tenofovirdisoproxil
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
Danish: Hvordan virker Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva?
English: However, do not take two doses on the same day.
Danish: Du må ikke tage to doser den samme dag.
English: Date of first authorisation: 28 September 2012 Date of latest renewal: 26 July 2017
Danish: Dato for første markedsføringstilladelse: 28. september 2012 Dato for seneste fornyelse: 26. juli 2017
English: Why didn't the inhaler make a noise when I inhaled?
Danish: Hvorfor lavede inhalatoren ikke en lyd da jeg inhalerede?
English: You can inhale this medicine anytime before or after food or drink.
Danish: Du kan inhalere denne medicin på hvilket som helst tidspunkt før og efter indtagelse af mad og drikke.
English: Children and adolescents Do not give this medicine to children or adolescents below the age of 18 years.
Danish: Børn og unge Denne medicin må ikke gives til børn eller unge under 18 år.
English: However in 40% of cases symptoms continued for the entire 6month period.
Danish: I 40 % af tilfældene fortsatte symptomerne dog i den fulde 6 måneders periode.
English: You have not received enough of your medicine.
Danish: Du har ikke fået en tilstrækkeligt mængde af din medicin.
English: Patients should be instructed not to take more than one dose in a day.
Danish: Patienterne skal informeres om, at de ikke må tage mere end en dosis om dagen.
English: This will also help you to remember to use it.
Danish: Det hjælper dig også med at huske at tage medicinen.
English: Then take the next dose as usual.
Danish: Tag derefter næste dosis til sædvanlig tid.
English: Hold your breath for up to 5 seconds.
Danish: Hold vejret Hold vejret i op til 5 sekunder.
English: As long as the capsule is empty you have received enough of your medicine.
Danish: Så længe kapslen er tom, har du fået en tilstrækkelig mængde af din medicin.
English: This medicine contains lactose.
Danish: Dette lægemiddel indeholder lactose.
English: There are no data from the use of this medicine in pregnant women and it is not known whether the active substance of this medicine passes into human milk.
Danish: Der er ingen data om brug af dette lægemiddel til gravide kvinder, og det vides ikke, hvorvidt det aktive stof i denne medicin udskilles i human mælk.
English: Patients who do not experience improvement in breathing should be asked if they are swallowing the medicinal product rather than inhaling it.
Danish: Patienter, der ikke oplever en forbedring i vejrtrækningen, skal spørges, om de synker lægemidlet i stedet for at inhalere den.
English: Gastrointestinal effects including gastroenteritis and dyspepsia were also observed.
Danish: Gastrointestinale virkninger, herunder gastroenteritis og dyspepsi blev ligeledes observeret.
English: Do not use more than your doctor tells you to use.
Danish: Brug ikke mere end den dosis lægen anbefaler dig at bruge.
English: If you use this medicine once a day, it will help to reduce the effects of COPD on your everyday life.
Danish: Hvis du tager dette lægemiddel én gang dagligt, vil det mindske påvirkningen af KOL i din dagligdag.
English: In addition, the corresponding frequency category for each adverse reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: Derudover er den tilsvarende hyppighedskategori for hver bivirkning baseret på følgende konvention: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If a dose is missed, the next dose should be taken as soon as possible.
Danish: Hvis en dosis glemmes, skal næste dosis tages hurtigst muligt.
English: Some side effects may be serious, but the frequency of these side effects is not known (frequency cannot be estimated from the available data)
Danish: Nogle bivirkninger kan være alvorlige, men hyppigheden af disse bivirkninger er ikke kendt (hyppighed kan ikke estimeres ud fra forhåndenværende data)
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a signifcant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Elimination After intravenous administration of [
Danish: Elimination Efter intravenøs administration af [
English: Insufficient pharmacokinetic data is available for other ethnicities or races.
Danish: Der er utilstrækkelige farmakokinetiske data for andre etniske grupper eller racer.
English: • High level of blood sugar (hyperglycaemia: typical symptoms include excessive thirst or hunger and frequent urination)
Danish: • Højt blodsukkerniveau (hyperglykæmi: sædvanlige symptomer er overdreven tørst eller sult og hyppig vandladning)
English: The most common anticholinergic adverse reaction was dry mouth (2.4%).
Danish: Den mest almindelige antikolinerge bivirkning var tørhed i munden (2,4 %).
English: The safety profile is further characterised by other symptoms related to the anticholinergic effects, including signs of urinary retention, which were uncommon.
Danish: Sikkerhedsprofilen er yderligere karakteriseret af andre symptomer relateret til antikolinerge virkninger, herunder tegn på urinvejsretention, som var ikke almindelige.
English: A population pharmacokinetic analysis of data in COPD patients identified body weight and age as factors contributing to inter-patient variability in systemic exposure.
Danish: En farmakokinetisk populationsanalyse af data fra KOL-patienter klarlagde kropsvægt og alder som de faktorer, der bidrager til variation i systemisk eksponering mellem patienter.
English: If you forget to inhale a dose, take one as soon as possible.
Danish: Hvis du har glemt at inhalere en dosis, så tag den hurtigst muligt.
English: There are no data from the use of Tovanor Breezhaler in pregnant women.
Danish: Der er ingen data fra anvendelse af Tovanor Breezhaler til gravide kvinder.
English: • Stomach discomfort after meals
Danish: • Ubehag i maven efter måltider
English: The capsule may be stuck in the capsule chamber.
Danish: Kapslen kan muligvis sidde fast i kammeret.
English: No new cases of dry mouth were reported in months 7-12.
Danish: Der rapporteredes ingen nye tilfælde af mundtørhed i månederne 7-12.
English: Other effects
Danish: Andre virkninger
English: Therefore the frequency was calculated from clinical trial experience.
Danish: Derfor er frekvensberegningen baseret på erfaring fra kliniske studier.
English: Elderly people You can use this medicine if you are aged 75 years and over at the same dose as for other adults.
Danish: Ældre Du kan bruge denne medicin ved samme dosis som for andre voksne, hvis du er 75 år eller ældre.
English: It is unknown whether glycopyrronium bromide is excreted in human milk.
Danish: Det er ukendt, om glycopyrroniumbromid udskilles i human mælk.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisteren efter ”EXP”.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, anticholinergics, ATC code: R03BB06
Danish: Farmakoterapeutisk klassifikation: lægemiddel mod obstruktiv luftvejslidelse, antikolinerge midler, ATC-kode: R03BB06
English: About 90% of systemic exposure following inhalation is due to lung absorption and 10% is due to gastrointestinal absorption.
Danish: Omkring 90 % af den systemiske eksponering efter inhalation skyldes absorption i lungerne, 10 % skyldes gastrointestinal absorption.
English: In both studies, the percentage of patients experiencing a moderate or severe exacerbation (defined as requiring treatment with systemic corticosteroids and/or antibiotics or hospitalisation) was reduced.
Danish: I begge studier var procentdelen af patienter, der oplevede moderate til svære eksacerbationer (defineret som krævende behandling med systemiske kortikosteroider og/eller antibiotika eller indlæggelse), reduceret.
English: Dry mouth was reported mainly during the first 4 weeks of treatment with a median duration of four weeks in the majority of patients.
Danish: Mundtørhed blev hovedsageligt rapporteret i løbet af de første 4 ugers behandling med en median varighed på fire uger for størstedelen af patienterne.
English: However, paradoxical bronchospasm has been observed with other inhalation therapy and can be life-threatening.
Danish: Paradoks bronkospasme er dog observeret ved anden inhalationsbehandling og kan være livstruende.
English: Renal elimination of parent drug accounts for about 60 to 70% of total clearance of systemically available glycopyrronium whereas non-renal clearance processes account for about 30 to 40%.
Danish: Renal udskillelse af moderstoffet står for ca. 60 til 70 % af den totale clearance af systemisk tilgængeligt glycopyrronium, mens ikke-renale clearanceprocesser står for ca. 30 til 40 %.
English: • Voice alteration (hoarseness)
Danish: • Ændring af stemmen (hæshed)
English: High doses of glycopyrronium may lead to anticholinergic signs and symptoms for which symptomatic treatment may be indicated.
Danish: Store doser af glycopyrronium kan medføre antikolinerge tegn og symptomer, hvor symptomatisk behandling kan være indiceret.
English: There were no major differences in total systemic exposure (AUC) between Japanese and Caucasian subjects following inhalation of glycopyrronium bromide.
Danish: Der var ingen større forskelle i total systemisk eksponering (AUC) mellem japanske og kaukasiske forsøgspersoner efter inhalation af glycopyrroniumbromid.
English: There is no relevant use of Tovanor Breezhaler in the paediatric population (under 18 years) in the indication COPD.
Danish: Det er ikke relevant at anvende Tovanor Breezhaler hos den pædiatriske population (under 18 år) ved indikationen KOL.
English: 1) More frequent for glycopyrronium than placebo in the 12 months database only.
Danish: 1) Kun mere hyppigt for glycopyrronium end for placebo i 12 måneders databasen.
English: Some elderly patients above 75 years of age experienced headache (frequency common) and urinary tract infection (frequency common).
Danish: Visse ældre patienter over 75 år kan opleve hovedpine (almindeligt forekommende) og urinvejsinfektion (almindeligt forekommende).
English: If you have questions about how long to continue your treatment with this medicine, talk to your doctor or pharmacist.
Danish: Hvis du har spørgsmål om, hvor lang tid du skal fortsætte din behandling med dette lægemiddel, skal du tale med din læge eller apotekspersonalet.
English: - if you experience eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes.
Danish: - hvis du oplever øjensmerter eller -ubehag, midlertidig sløring af synet, visuelle ringe eller farvet syn i forbindelse med røde øjne.
English: 3) Seen more frequently for glycopyrronium than placebo in elderly >75 years only.
Danish: 3) Kun set mere hyppigt for glycopyrronium end for placebo hos ældre >75 år.
English: These may be signs of an acute attack of narrow-angle glaucoma.
Danish: Dette kan være tegn på et akut anfald af snævervinklet glaukom.
English: Symptomatic outcomes
Danish: Symptomatiske endepunkter
English: • Painful and frequent urination
Danish: • Smertefuld eller hyppig vandladning
English: • One or more blister cards, each containing either 6 or 10 Seebri Breezhaler capsules to be used in the inhaler
Danish: • Et eller flere blisterkort, som hver indeholder enten 6 eller 10 Tovanor Breezhaler kapsler til brug i inhalatoren
English: Tovanor Breezhaler once daily has also shown a statistically significant effect on health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ).
Danish: Tovanor Breezhaler én gang dagligt har ligeledes vist en statistisk signifikant virkning på helbredsrelateret livskvalitet målt ved hjælp af St. George's Respiratory Questionnaire (SGRQ).
English: It has a rapid onset of action as evidenced by observed receptor association/dissociation kinetic parameters and the onset of action after inhalation in clinical studies.
Danish: Det har en hurtig indsættende virkning, hvilket er påvist ved observerede kinetiske parametre for receptorassociation/-dissociation og ved indsættende virkning efter inhalation i kliniske studier.
English: Reproduction studies and other data in animals do not indicate a concern regarding fertility in either males or females (see section 5.3).
Danish: Reproduktionsstudier og andre data fra dyr indikerer ikke problemer i forbindelse med fertilitet hos hverken mænd eller kvinder (se pkt.
English: Acute intoxication by inadvertent oral ingestion of Tovanor Breezhaler capsules is unlikely due to the low oral bioavailability (about 5%).
Danish: Akut forgiftning ved utilsigtet oral indtagelse af Tovanor Breezhaler-kapsler er ikke sandsynlig pga. den lave orale biotilgængelighed (omkring 5 %).
English: The majority of the reports of dry mouth were suspected to be related to the medicinal product and were mild, with none being severe.
Danish: Størstedelen af rapporteringerne om mundtørhed formodedes at være relateret til lægemidlet og var milde.
English: If you use more Tovanor Breezhaler than you should If you have inhaled too much of this medicine or if someone else accidentally uses your capsules, you must immediately either tell your doctor or go to the nearest emergency unit.
Danish: Hvis du har brugt for meget Tovanor Breezhaler Hvis du har inhaleret for meget af dette lægemiddel, eller hvis andre personer ved et uheld bruger dine kapsler, skal du øjeblikkeligt fortælle det til din læge eller henvende dig til den nærmeste skadestue.
English: Tovanor Breezhaler should be used with caution in these patient groups.
Danish: Tovanor Breezhaler bør derfor bruges med forsigtighed i disse patientgrupper.
English: Hydroxylation resulting in a variety of mono-and bis-hydroxylated metabolites and direct hydrolysis resulting in the formation of a carboxylic acid derivative (M9) were seen.
Danish: Der sås hydroxylering, som medførte en række mono- og bis-hydroxylerede metabolitter, og direkte hydrolyse, som medførte dannelsen af et carboxylsyrederivat (M9).
English: Tovanor Breezhaler 44 micrograms once daily can be safely used in all age and body weight groups.
Danish: Tovanor Breezhaler 44 mikrogram én gang dagligt kan anvendes sikkert i alle alders- og vægtgrupper.
English: Glucuronide and/or sulfate conjugates of glycopyrronium were found in urine of humans after repeated inhalation, accounting for about 3% of the dose.
Danish: Glukuronid- og/eller sulfatkonjugater af glycopyrronium blev fundet i urin hos mennesker efter gentagen inhalation og udgør ca. 3 % af dosis.
English: Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Tovanor Breezhaler and to contact their doctor immediately should any of these signs or symptoms develop.
Danish: Patienter skal informeres om tegn og symptomer på akut snævervinklet glaukom og skal informeres om øjeblikkelig seponering af Tovanor Breezhaler og kontakte lægen, hvis patienten udvikler nogle af disse tegn eller symptomer.
English: The recommended dose is the inhalation of the content of one capsule once daily using the Tovanor Breezhaler inhaler.
Danish: Den anbefalede dosis er inhalation af indholdet i en kapsel én gang dagligt ved hjælp af Tovanor Breezhaler-inhalatoren.
English: Each blister strip contains either 6 or 10 hard capsules.
Danish: Hvert blisterkort indeholder enten 6 eller 10 hårde kapsler.
English: Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Danish: Brug ikke lægemidlet, hvis pakningen er beskadiget eller viser tegn på at have været åbnet.
English: Do not use Tovanor Breezhaler - if you are allergic to glycopyrronium bromide or any of the other ingredients of this medicine
Danish: Brug ikke Tovanor Breezhaler - hvis du er allergisk over for glycopyrroniumbromid eller et af de øvrige indholdsstoffer i
English: Glycopyrronium has no or negligible influence on the ability to drive and use machines.
Danish: Glycopyrronium påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Immediate hypersensitivity reactions have been reported after administration of Tovanor Breezhaler.
Danish: Der er rapporteret øjeblikkelige overfølsomhedsreaktioner efter administration af Tovanor Breezhaler.
English: • Swelling mainly of the tongue, lips, face or throat (possible signs of angioedema) If you get any of these side effects, tell your doctor immediately.
Danish: • Hævelse, hovedsagelig af tunge, læber, ansigt eller hals (mulige tegn på angioødem) Hvis oplever en af disse bivirkninger, skal du kontakte din læge med det samme.
English: During treatment with Tovanor Breezhaler, stop taking this medicine and tell your doctor immediately: - if you experience tightness of the chest, coughing, wheezing or breathlessness immediately after using Tovanor Breezhaler (signs of bronchospasm).
Danish: Under behandling med Tovanor Breezhaler, stop med at tage medicinen og fortæl det øjeblikkeligt til din læge: - hvis du oplever trykken for brystet, hoste, hvæsen eller åndenød umiddelbart efter, du har taget Tovanor Breezhaler (tegn på bronkospasme).
English: The magnitude of the effect was dependent on the degree of reversibility of airflow limitation at baseline (tested by administration of a short-acting muscarinic antagonist bronchodilator): Patients with the lowest degree of reversibility at baseline (<5%) generally exhibited a lower bronchodilator response than patients with a higher degree of reversibility at baseline (≥5%).
Danish: Virkningens størrelse var afhængig af graden af reversibilitet i luftvejsbegrænsning ved baseline (testet ved administration af en korttidsvirkende muskarin antagonist bronkodilator): patienter med den mindste grad af reversibilitet ved baseline (<5 %) viste generelt et lavere bronkodilaterende respons end patienter med en større grad af reversibilitet ved baseline (≥5 %).
English: Check capsule is empty Open the inhaler to see if any powder is left in the capsule.
Danish: Tjek at kapslen er tom Åben inhalatoren for at kontrollere, om der er overskydende pulver i kapslen.
English: If this happens, carefully loosen the capsule by tapping the base of the inhaler.
Danish: Hvis dette er tilfældet, skal du forsigtigt løsne kapslen ved at banke let på inhalatorens underdel.
English: Excipient(s) with known effect: Each capsule contains 23.6 mg lactose (as monohydrate).
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på: Hver kapsel indeholder 23,6 mg lactose (som monohydrat).
English: The elimination pattern suggests sustained lung absorption and/or transfer of glycopyrronium into the systemic circulation at and beyond 24 hours after inhalation.
Danish: Elimineringsmønstret tyder på vedvarende absorption i lungerne og/eller overførelse af glycopyrronium i den systemiske cirkulation ved og efter 24 timer efter inhalation.
English: Adverse reactions related to local tolerability included throat irritation, nasopharyngitis, rhinitis and sinusitis.
Danish: Bivirkninger, relateret til lokal tolerabilitet, omfattede halsirritation, nasopharyngitis, rhinitis og sinusitis.
English: Based on the magnitude of these changes, no clinically relevant drug interaction is expected when glycopyrronium is co-administered with cimetidine or other inhibitors of organic cation transport.
Danish: På baggrund af disse ændringers omfang forventes der ingen klinisk relevant lægemiddelinteraktion, når glycopyrronium administreres sammen med cimetidin eller andre hæmmere af organisk kation-transport.
English: Following oral inhalation using the Tovanor Breezhaler inhaler, glycopyrronium was rapidly absorbed and reached peak plasma levels at 5 minutes post dose.
Danish: Efter oral inhalation med Tovanor Breezhaler-inhalatoren blev glycopyrronium hurtigt absorberet og nåede maksimale plasmaniveauer 5 minutter efter dosis.