FrancophonIA/ELRC3.0 huggingface dataset:
English: The results of this study suggest that Viani 50/100mcg bd may be considered as initial maintenance therapy in patients with moderate persistent asthma for whom rapid control of asthma is deemed essential (see section 4.2).
Danish: Undersøgelsesresultaterne antyder, at Viani 50/100 mikrogram 2 gange daglig kan overvejes som første vedligeholdelsesbehandling hos patienter med moderat astma, hvor der er behov for hurtig astmakontrol (se pkt.
English: Laboratoire GlaxoSmithKline 100 route de Versailles 78163 Marly-le-roi Cedex France
Danish: Laboratoire GlaxoSmithKline 100 route de Versailles 78163 Marly-le-roi Cedex, Frankrig
English: Patients should be given the strength of Viani containing the appropriate fluticasone propionate dosage for the severity of their disease.
Danish: Patienterne skal have Viani i den styrke fluticasonpropionat, der passer til sværhedsgraden af deres astma.
English: In addition to the update in section 4.2 of the SPC, some factual data from the GOAL study in particular the timing of reaching more rapidly control with Viani than with ICS alone have been included in section 5.1 “Pharmacodynamic properties” of the SPC.
Danish: Foruden ajourføringen af produktresuméets afsnit 4.2 er der i afsnit 5.1 "Farmakodynamiske egenskaber" indsat visse faktuelle oplysninger fra GOAL-undersøgelsen, navnlig vedrørende det tidsmæssige aspekt ved opnåelse af hurtigere kontrol med Viani end med inhalerede corticosteroider alene.
English: The doctor will prescribe the lowest strength of Viani Diskus that will best control your symptoms.
Danish: Din læge vil bestræbe sig på at ordinere den laveste dosis Viani, som kan holde dine symptomer under kontrol.
English: GlaxoSmithKline GmbH & Co KG Theresienhoehe 11
Danish: GlaxoSmithKline GmbH & Co KG, Theresienhoehe 11, D-80339 Muenchen
English: Viani is indicated for the symptomatic treatment of patients with severe COPD (FEV1 <50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.
Danish: Til symptomatisk behandling af svær KOL (FEV1 <50 % af forventet) og tilbagevendende forværringer, hvor fast behandling med bronkodilatator ikke er tilstrækkelig.
English: No studies of the effect on the ability to drive and use machines have been performed.
Danish: Vianis effekt på evnen til at køre bil eller betjene maskiner er ikke undersøgt.
English: POSSIBLE SIDE EFFECTS
Danish: HVILKE MULIGE BIVIRKNINGER HAR VIANI
English: Viani contains salmeterol and fluticasone propionate which have differing modes of action.
Danish: Virkningsmekanisme: Viani indeholder både salmeterol og fluticasonpropionat, der virker forskelligt, og beskrives herunder:
English: Mechanism of action:
Danish: Afprøvningsresultater:
English: - The active substance(s) are 50 micrograms salmeterol (as xinafoate) and 100, 250 or 500
Danish: Viani indeholder - De aktive stoffer er 50 mikrogram salmeterol som salmeterolxinafoat og 100, 250 eller 500
English: HOW TO STORE VIANI
Danish: HVORDAN DU OPBEVARER VIANI
English: In cases of fluticasone propionate overdose Viani therapy may still be continued at a suitable dosage for symptom control.
Danish: Ved overdosering af fluticasonpropionat kan behandling med Viani fortsættes i laveste effektive dosis.
English: Inhalation powder, predispensed
Danish: Inhalationspulver, afdelt i Diskus.
English: Do not use Viani to treat a sudden attack of breathlessness or wheezing as it will not help you immediately.
Danish: Viani virker ikke på pludselige anfald af åndenød og hvæsende vejrtrækning, den har ikke en øjeblikkelig virkning.
English: The Diskus device holds blisters containing Viani in powder form.
Danish: Diskus indeholder folieblisterbånd med Viani inhalationspulver.
English: The time on treatment for 50% of subjects to achieve a first individual Well Controlled week was 16 days for Viani compared to 37 days for the ICS group.
Danish: Der gik 16 dage med behandling med Viani, før 50% af patienterne opnåede velkontrolleret astma i sammenligning med 37 dage for den gruppe, der fik inhalationssteroid alene.
English: Only take these medicines whilst on Viani, if told to do so by your doctor.
Danish: Når du tager Viani, må du kun tage disse lægemidler efter lægens anvisning.
English: Luxembourg GlaxoSmithKline s.a./n.v.
Danish: Luxembourg GlaxoSmithKline s.a./n.v., Rue du Tilleul 13,
English: The possible side effects associated with Viani are unlikely to affect your ability to drive or use machines.
Danish: Bilkørsel og betjening af maskiner Viani påvirker ikke arbejdssikkerheden eller evnen til at færdes sikkert i trafikken.
English: Presenting symptoms are typically vague and may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, hypotension, decreased level of consciousness, hypoglycaemia, and seizures.
Danish: infektion eller for hurtig nedsættelse af dosis og kan føre til spisevægring, mavesmerter, vægttab, træthed, hovedpine, kvalme, opkastning, hypotension, opmærksomhedstab, hypoglykæmi og kramper.
English: What Viani looks like and contents of the pack Inhalation powder, pre-dispensed.
Danish: Produktets udseende og pakningsstørrelse Inhalationspulver, afdelt.
English: Some types of antiviral and antifungal medication (such as ritonavir, ketoconazole and itraconazole) may increase the amount of fluticasone propionate in your body and therefore increase your risk of having side effects.
Danish: Viani bør ikke tages sammen med beta-blokkere (fx atenolol, propranolol, sotalol), med mindre din læge har ordineret det. Nogle typer medicin mod virus og svamp (fx ritonavir, ketoconazol og itraconazol) kan øge mængden af fluticasonpropionat i kroppen og derved øge risikoen for bivirkninger.
English: In the subset of steroid naive asthmatics the time to an individual Well Controlled week was 16 days in the Viani treatment compared to 23 days following treatment with ICS.
Danish: I en undergruppe bestående af patienter, der ikke før havde fået steroider, gik der 16 dage, før patienterne var velkontrollerede, hvorimod der gik 23 dage med inhalationssteroid alene.
English: If you are allergic (hypersensitive) to salmeterol xinafoate, fluticasone propionate or to the other ingredient lactose monohydrate.
Danish: Du bør ikke anvende Viani - hvis du er overfølsom over for salmeterol, fluticasonpropionat eller lactose.
English: In the event of once daily dosing when the patient has a history of nocturnal symptoms the dose should be given at night and when the patient has a history of mainly day-time symptoms the dose should be given in the morning.
Danish: I så fald anbefales det, at patienter med natlige symptomer tager Viani om aftenen, og patienter med symptomer om dagen tager Viani om morgenen.
English: As Viani contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the compounds may be expected.
Danish: Da Viani indeholder salmeterol og fluticasonpropionat, må der forventes samme bivirkninger som ved administration af disse stoffer.
English: METHOD OF ADMINISTRATION Read the package leaflet before use
Danish: ANVENDELSESMÅDE Læs indlægssedlen inden brug UDLØBSDATO Anvendes senest BATCHNUMMER
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: [See Annex I - To be completed nationally] Manufacturer:
Danish: Indehaveren af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelsen <[Se bilag I - Udfyldes nationalt]>
English: The inhalation powder is contained in blisters held on a formed PVC coated base, with a peelable foil laminate lid.
Danish: Viani inhalationspulver leveres i Diskus, som indeholder en foliestrimmel med blistre med de enkelte doser.
English: Viani COPD clinical trials
Danish: Kliniske afprøvninger med Viani til KOL
English: SUMMARY OF PRODUCT CHARACTERISTICS
Danish: FARMAKOLOGISKE EGENSKABER
English: Viani 50/100 micrograms strength is not appropriate in adults and children with severe asthma; it is recommended to establish the appropriate dosage of inhaled corticosteroid before any fixed combination can be used in patients with severe asthma.
Danish: Viani 50/100 mikrogram er uegnet til voksne og børn med alvorlig astma.
English: Where the control of symptoms is maintained with the lowest strength of the combination given twice daily then the next step could include a test of inhaled corticosteroid alone.
Danish: Hvis symptomerne kan kontrolleres ved behandling med Viani i laveste styrke to gange dagligt, kan behandling med inhalationssteroid alene eventuelt forsøges, eller de patienter, der også har behov for langtidsvirkende ß2-agonister, kan titreres ned til Viani én gang dagligt.
English: Viani should be administered with caution in patients with severe cardiovascular disorders, including heart rhythm abnormalities, diabetes mellitus, untreated hypokalaemia or thyrotoxicosis.
Danish: hjertearytmi, diabetes mellitus, ubehandlet hypokaliæmi og tyreotoksikose.
English: For example, 100mcg of fluticasone propionate is approximately equivalent to 200mcg of beclomethasone dipropionate (CFC containing) or budesonide.
Danish: Moderat dosis inhalationssteroid (>5001000mikg beclometasondipropionat eller tilsvarende/dgl.)
English: Situations, which could potentially trigger acute adrenal crisis include trauma, surgery, infection or any rapid reduction in dosage.
Danish: Akut binyrebarkinsufficiens kan opstå på grund af traume, operation,
English: Care should be taken when transferring patients to Viani therapy, particularly if there is any reason to suppose that adrenal function is impaired from previous systemic steroid therapy.
Danish: Hvis binyrebarkfunktionen er nedsat på grund af tidligere brug af systemiske steroider bør der især udvises forsigtighed ved igangsættelse af behandling med Viani.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Asthma Viani is indicated in the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: - patients not adequately controlled with inhaled corticosteroids and ‘as needed' inhaled short acting beta-2-agonist or
Danish: Astma Til behandling af astma, hvor behandling med en kombinationsprodukt (langtidsvirkende ß2-agonist og inhalationssteroid) er hensigtsmæssig: - hos patienter, der ikke er velkontrollerede på inhalationssteroid og korttidsvirkende ß2-agonist ved behov, eller - hos patienter, der allerede er velkontrollerede på både inhalationssteroid og langtidsvirkende ß2-agonist.OBS: Viani 50/100 mikrogram er uegnet til både børn og voksne med alvorlig astma.
English: Viani Diskus and associated names (see Annex I) 50/250 microgram/dose inhalation powder, predispensed [See Annex I - To be completed nationally]
Danish: Viani Diskus og andre navne (se bilag I) 50/250 mikrogram/dosis inhalationspulver, afdelt [Se bilag I - Udfyldes nationalt]
English: STATEMENT OF ACTIVE SUBSTANCE(S) 50 micrograms of salmeterol (as xinafoate) and 250 micrograms of fluticasone propionate per actuation
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Salmeterol som salmeterolxinafoat 50 mikrogram og fluticasonpropionat 250 mikrogram pr. dosis LISTE OVER HJÆLPESTOFFER [Udfyldes nationalt]
English: Viani Diskus and associated names (see Annex I) 50/500 microgram/dose inhalation powder, predispensed [See Annex I - To be completed nationally]
Danish: Viani Diskus og andre navne (se bilag I) 50/500 mikrogram/dosis inhalationspulver, afdelt [Se bilag I - Udfyldes nationalt]
English: Viani Diskus and associated names (see Annex I) 50/100 microgram/dose inhalation powder, predispensed [See Annex I - To be completed nationally]
Danish: Viani Diskus og andre navne (se bilag I) 50/100 mikrogram/dosis inhalationspulver, afdelt [Se bilag I - Udfyldes nationalt]
English: - When you close the Diskus, it clicks shut.
Danish: Diskus lukkes efter brug.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 50 micrograms of salmeterol (as xinafoate) and 100 micrograms of fluticasone propionate per actuation
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Salmeterol som salmeterolxinafoat 50 mikrogram og fluticasonpropionat 100 mikrogram pr. dosis LISTE OVER HJÆLPESTOFFER [Udfyldes nationalt]
English: For patients with asthma or COPD, consideration should be given to additional corticosteroid therapies.
Danish: Der bør udvises forsigtighed ved lungetuberkulose, som ved al anden inhalationsbehandling med kortikosteroider.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Fortegnelse over hjælpestoffer Lactosemonohydrat (indeholder mælkeproteiner) 6.2 Uforligeligheder
English: STATEMENT OF ACTIVE SUBSTANCE(S) 50 micrograms of salmeterol (as xinafoate) and 500 micrograms of fluticasone propionate per actuation
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Salmeterol som salmeterolxinafoat 50 mikrogram og fluticasonpropionat 500 mikrogram pr. dosis LISTE OVER HJÆLPESTOFFER [Udfyldes nationalt]
English: The doctor will assess whether you can take Viani during this time.
Danish: Din læge kan ordinere behandling af svamp, samtidig med at du tager Viani.
English: BEFORE YOU TAKE VIANI
Danish: HVAD DU SKAL GØRE, FØR DU BEGYNDER AT TAGE VIANI
English: The respective mechanisms of action of both drugs are discussed below:
Danish: En liste over alle hjælpestoffer er anført under.
English: Normalization of:f
Danish: Normalisering af:f
English: Patients treated and monitored for resistance b
Danish: Patienter behandlet og monitoreret for resistensb
English: All doses should be taken once daily orally (by mouth).
Danish: Alle doseringer tages én gang dagligt oralt (igennem munden).
English: Stable or improved CTP scoreb,d MELD score
Danish: Stabilt eller forbedret CTP-talb,d MELD-score
English: Your dose will depend on: whether you have been treated for HBV infection before, and what medicine you received.
Danish: Din dosis afhænger af: om du tidligere er behandlet for HBV-infektion, og hvilken medicin du fik.
English: *p<0.05 ULN=upper limit of normal, LLN=lower limit of normal.
Danish: * p<0,05 ULN = øvre normalgrænse, LLN = nedre normalgrænse.
English: Results beyond 48 weeks of treatment
Danish: Resultater efter 48 ugers behandling
English: A reduction of the daily dose using an oral solution is recommended.
Danish: Det anbefales at reducere den daglige dosis ved at anvende en oral opløsning.
English: The randomization was stratified by age group (2 to 6 years; >6 to 12 years; and >12 to <18 years).
Danish: Randomiseringen blev stratificeret efter aldersgruppe (2 til 6 år; >6 til 12 år og >12 til <18 år).
English: Patients treated with entecavir have reported the following side effects:
Danish: Patienter behandlet med entecavir har indberettet følgende bivirkninger:
English: The two trials provide resistance data in 183 patients treated and monitored in Year 1 and 180 patients treated and monitored in Year 2.
Danish: De to studier tilvejebringer resistensdata hos 183 patienter, der behandles og monitoreres i år 1, og 180 patienter, der behandles og monitoreres i år 2.
English: Your child's doctor will decide the right dose based on your child's weight.
Danish: Barnets læge vil fastsætte den korrekte dosis ud fra barnets vægt.
English: Rare (at least 1 in 10,000 patients): severe allergic reaction.
Danish: Sjælden (kan forekomme hos mindst 1 ud af 10.000 patienter): alvorlig allergisk reaktion.
English: Clinical resistance in adults
Danish: Klinisk resistens hos voksne
English: <Date of first authorisation: {DD month YYYY}> <Date of latest renewal: {DD month YYYY}>
Danish: Dato for første markedsføringstilladelse: {DD måned ÅÅÅÅ} Dato for seneste fornyelse: {DD måned ÅÅÅÅ}
English: Frequency is defined as 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).
Danish: Hyppighed defineres som 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).
English: Diameter: approximately 6.8 mm.
Danish: Diameter: ca. 6,8 mm.
English: e ETVr occurring in any year; virologic breakthrough in specified year.
Danish: e ETVr der forekommer i et givent år; virologisk svigt i det specificerede år.
English: common: insomnia
Danish: almindelig: insomni
English: AUC was 14% higher in women than in men, due to differences in renal function and weight.
Danish: AUC var 14% højere hos kvinder end hos mænd på grund af forskellen i nyrefunktion og vægt.
English: Co-infection with hepatitis C or D
Danish: Samtidig infektion med hepatitis C eller D
English: An oral solution should be used for patients with body weight less than 32.6 kg.
Danish: Oral opløsning bør anvendes til patienter med en kropsvægt under 32,6 kg.
English: 117 Allée des Parcs 69800 Saint Priest France
Danish: 117 Allée des Parcs 69800 Saint Priest Frankrig
English: When your treatment with Entecavir Mylan is stopped, your doctor will continue to monitor you and take blood tests for several months.
Danish: Hvis behandlingen med Entecavir Mylan skal stoppes, vil din læge følge dig og tage blodprøver igennem flere måneder.
English: The estimated volume of distribution for entecavir is in excess of total body water.
Danish: Det estimerede fordelingsvolumen for entecavir er større end kroppens totale vandindhold.
English: After adjusting for differences in creatinine clearance and body weight, elderly subjects had a 12.5% higher AUC than young subjects.
Danish: Efter justering for forskelle i kreatinin-clearance og kropsvægt havde ældre patienter 12,5% højere AUC end yngre patienter.
English: A 4-hour period of haemodialysis removed ≈ 13% of the dose, and 0.3% was removed by CAPD.
Danish: En 4 timers hæmodialyseperiode fjernede ≈ 13% af dosis, og 0,3% blev fjernet ved CAPD.
English: There are no adequate data from the use of entecavir in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af entecavir hos gravide kvinder.
English: Diameter: approximately 8.8 mm.
Danish: Diameter: ca. 8,8 mm.
English: The decision to treat paediatric patients should be based on careful consideration of individual patient needs and with reference to current paediatric treatment guidelines including the value of baseline histological information.
Danish: Beslutningen om at behandle pædiatriske patienter bør være baseret på en omhyggelig vurdering af den enkelte patients behov og i henhold til gældende retningslinjer for pædiatrisk behandling, herunder histologiske oplysninger ved baseline.
English: Some patients must take Entecavir Mylan on an empty stomach (see Entecavir Mylan with food and drink in Section 2).
Danish: Nogle patienter skal tage Entecavir Mylan på tom mave (se Brug af Entecavir Mylan sammen med mad og drikke i afsnit 2).
English: Entecavir Mylan will not control your HIV infection.
Danish: Entecavir Mylan vil ikke kontrollere din hiv-infektion.
English: If your liver disease is very advanced, your doctor will also instruct you to take Entecavir Mylan on an empty stomach.
Danish: Hvis din leversygdom er meget fremskreden, vil lægen ligeledes vejlede dig i, at du skal tage Entecavir Mylan på tom mave.
English: Children and adolescents (from 2 to less than 18 years of age) can take Entecavir Mylan with or without food.
Danish: Børn og unge (fra 2-18 år) kan tage Entecavir Mylan med eller uden mad.
English: This is important because Entecavir Mylan is eliminated from your body through the kidneys and your dose or dosing schedule may need to be adjusted.
Danish: Det er vigtigt, fordi Entecavir Mylan udskilles gennem nyrerne, og din dosis eller dosisintervallet skal tilpasses.
English: Do not take Entecavir Mylan if you are allergic (hypersensitive) to entecavir or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Entecavir Mylan hvis du er allergisk over for entecavir eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: It is important that women of childbearing age receiving treatment with Entecavir Mylan use an effective method of contraception to avoid becoming pregnant.
Danish: Det er vigtigt, at frugtbare kvinder, som er i behandling med Entecavir Mylan, anvender effektiv svangerskabsforebyggelse for at forhindre graviditet.
English: Entecavir Mylan reduces the amount of virus in your body, and improves the condition of the liver.
Danish: Entecavir Mylan mindsker mængden af virus i kroppen og forbedrer leverens tilstand
English: Patients should be advised that therapy with entecavir has not been proven to reduce the risk of transmission of HBV and therefore appropriate precautions should still be taken.
Danish: Patienterne skal informeres om, at det ikke er påvist, at behandling med entecavir mindsker risikoen for overførsel af HBV, og at der derfor fortsat skal tages relevante forholdsregler.
English: Elderly: no dosage adjustment based on age is required.
Danish: Ældre: Dosisjustering er ikke nødvendig på baggrund af alder.
English: d ≥1 log10 increase above nadir in HBV DNA by PCR, confirmed with successive measurements or at the end of the windowed time point.
Danish: d ≥1 log10 stigning over nadir i HBV-DNA ved PCR, bekræftet ved på hinanden følgende målinger eller ved afslutningen af tidsvinduet.
English: Children and adolescents Entecavir Mylan should not be used for children below 2 years of age or weighing less than 10 kg.
Danish: Børn og unge Entecavir Mylan bør ikke anvendes til børn under 2 år eller børn, der vejer under 10 kg.
English: Tablet coating: titanium dioxide (E171), hypromellose, macrogol 400, polysorbate 80.
Danish: Tabletovertræk: Titandioxid (E171), hypromellose, macrogol 400, polysorbat 80.
English: Entecavir dosage* Nucleoside naïve patients
Danish: Entecavir-dosis* Nukleosid-naive patienter
English: Results for the main efficacy endpoints at Week 48 and Week 96 are presented in the table below.
Danish: Resultaterne for de vigtigste effekt endepunkter ved uge 48 og uge 96 er vist i nedenstående tabel.
English: Given that the potential risks to the developing foetus are unknown, women of childbearing potential should use effective contraception.
Danish: Da de potentielle risici for fostret ikke kendes, bør kvinder i den fertile alder bruge effektiv kontraception.
English: HAART regimens did not include emtricitabine or tenofovir disoproxil fumarate.
Danish: HAART-regimet indeholdt ikke emtricitabin eller tenofovirdisoproxilfumarat.
English: In studies in patients with compensated liver disease, histological improvement was defined as a ≥2point decrease in Knodell necro-inflammatory score from baseline with no worsening of the Knodell fibrosis score.
Danish: I studier med patienter med kompenseret leversygdom defineredes histologisk forbedring som et ≥2point fald i Knodell nekro-inflammatorisk score fra baseline uden forværring i Knodell fibrose-scoren.
English: Your doctor will monitor you regularly while you are receiving Entecavir Mylan.
Danish: Lægen vil jævnligt kontrollere dig, mens du tager Entecavir Mylan.
English: After reaching peak levels, entecavir plasma concentrations decreased in a bi-exponential manner with a terminal elimination half-life of ≈ 128-149 hours.
Danish: Efter maksimalt niveau er nået, falder plasmakoncentrationen af entecavir bi-eksponentielt med en halveringstid på ≈ 128-149 timer.
English: At 24 weeks the reduction in HBV viral load was significantly greater with entecavir (-3.65 vs an increase of 0.11 log10 copies/ml).
Danish: Ved 24 uger var fald i HBV viral load signifikant større med entecavir (-3,65 versus en stigning på 0,11 log10 kopier/ml).
English: discuss with your doctor whether your liver functions properly and, if not, what the possible effects on your Entecavir Mylan treatment may be.
Danish: tal med lægen om din lever fungerer ordentligt, og hvis ikke, find ud af, hvordan det kan påvirke din behandling med Entecavir Mylan.
English: Given the exposure margin, this finding is considered of unlikely clinical significance.
Danish: På grund af eksponeringmarginen anses det for usandsynligt, at disse fund har klinisk betydning.
English: Therefore, appropriate interventions should be used to prevent neonatal acquisition of HBV. Breast-feeding
Danish: Der bør derfor interveneres på relevant vis for at forhindre neonatal erhvervelse af HBV. Amning