FrancophonIA/ELRC3.0 huggingface dataset:
English: If the inhaler has not been used for a week or more remove the mouthpiece cover, the patients should shake the inhaler well and release two puffs into the air. Each time the inhaler is activated the number on the counter will count down by one.
Danish: Hvis inhalationssprayen ikke har været brugt i en uge eller længere, rystes den omhyggeligt, og to pust trykkes ud i luften.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) Udfyldes nationalt DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Udfyldes nationalt
English: Patients should not rush stages 4, 5 and 6.
Danish: 4, 5 og 6.
English: To remove the mouthpiece cover, hold the sides of the inhaler with your thumb and forefinger, squeeze the cover gently and pull apart.
Danish: Klem på siderne af beskyttelseshætten med tommel- og pegefinger og træk den forsigtigt af.
English: Percentage of Patients Attaining *Well Controlled (WC) and **Totally Controlled (TC) Asthma over 12 months
Danish: Patienter med astma, som i løbet af et år blev velkontrolleret*) eller hvor Total Kontrol**) blev opnået Salmeterol/fluticasonpropionat
English: Never try to alter the numbers on the counter or detach the counter from the metal can.
Danish: Prøv ikke at ændre på dosistælleren eller på anden måde at øve vold på den.
English: As with most inhaled medicinal products in pressurised containers, the therapeutic effect of this medicinal product may decrease when the container is cold.
Danish: Som med anden inhalationsmedicin bør sprayen ikke være kold på anvendelsestidspunktet, da det kan forringe den terapeutiske effekt.
English: Check inside and outside to make sure that the mouthpiece is clean and that there are no foreign objects.
Danish: Sørg for, at mundstykket er rent både indvendigt og udvendigt.
English: The devices are packed in cartons of 1, 3 or 10 Evohalers.
Danish: 1, 3 eller 10 x Evohaler.
English: Just after starting to breathe in through your mouth, press down on the top of the can to release a puff while still breathing in steadily and deeply.
Danish: Tryk beholderen ned i starten af en indånding gennem munden og inhalér dosis roligt og dybt.
English: Adverse events which have been associated with salmeterol/fluticasone propionate are given below, listed by system organ class and frequency.
Danish: Bivirkningerne er inddelt i henhold til organklasser og efter hyppighed.
English: Pressurised container.
Danish: Ryst sprayen.
English: GlaxoSmithKline GmbH & Co. KG Theresienhohe 11
Danish: GlaxoSmithKline GmbH & Co.
English: The devices are available in cardboard containers, which hold:
Danish: Inhalationsspray leveres I æsker med:
English: 25 micrograms of salmeterol (as salmeterol xinafoate) and 50, 125 or 250 micrograms of fluticasone propionate (delivered from the valve).
Danish: Salmeterol 25 mikrogram som salmeterolxinafoat og 50 mikrogram, 125 mikrogram eller 250 mikrogram fluticasonpropionat.
English: To make sure that it works, shake the inhaler well and press the can to release puffs into the air until the counter reads 120.
Danish: Tryk nogle pust ud i luften, indtil dosistælleren står på 120, for at sikre, at den virker ordentligt.
English: Just after starting to breathe in through their mouth, patients should press down on the top of the inhaler to release Viani, while still breathing in steadily and deeply.
Danish: Beholderen skal trykkes ned i starten af en indånding gennem munden, og dosis inhaleres roligt og dybt.
English: Viani should be administered with caution in patients with severe cardiovascular disorders, including heart rhythm abnormalities, diabetes mellitus, untreated hypokalaemia or thyrotoxicosis.
Danish: Viani bør gives med forsigtighed ved alvorlige hjerte-kar-sygdomme, inkl.
English: Viani is supplied to you in a metered dose inhaler which delivers your medicine in a pressurised suspension for you to inhale.
Danish: Viani inhalationsspray er en suspension, som skal omrystes før brug.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 25 micrograms of salmeterol (as xinafoate) and 125 micrograms of fluticasone propionate per actuation
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Salmeterol som salmeterolxinafoat 25 mikrogram og fluticasonpropionat 125 mikrogram pr. dosis
English: Breathe out as far as is comfortable.
Danish: Pust helt ud.
English: Consideration should be given to additional corticosteroid therapies.
Danish: Der bør udvises forsigtighed ved lungetuberkulose, som ved al anden inhalationsbehandling med kortikosteroider.
English: METHOD OF ADMINISTRATION Shake well before use Read the package leaflet before use
Danish: Patienten skal instrueres godt i, hvordan sprayen skal bruges, som beskrevet i indlægssedlen i pakningen.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 25 micrograms of salmeterol (as xinafoate) and 50 micrograms of fluticasone propionate per actuation
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Salmeterol som salmeterolxinafoat 25 mikrogram og fluticasonpropionat 50 mikrogram pr. dosis
English: This is equivalent to 21 micrograms of salmeterol and 44, 110 or 220 micrograms of fluticasone propionate delivered from the actuator (delivered dose).
Danish: Da noget af indholdet aflejres i sprayen, reduceres inhalationen til 21 mikrogram salmeterol og hhv. 44, 110 og 220 mikrogram fluticasonpropionat.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 25 micrograms of salmeterol (as xinafoate) and 250 micrograms of fluticasone propionate per actuation
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Salmeterol som salmeterolxinafoat 25 mikrogram og fluticasonpropionat 250 mikrogram pr. dosis
English: Viani Evohaler and associated names (see Annex I) 25/125 microgram/dose pressurised inhalation, suspension [See Annex I - To be completed nationally]
Danish: Viani Evohaler og andre navne (se bilag I) 25/125 mikrogram/dosis inhalationsspray [Se bilag I - Udfyldes nationalt]
English: Two inhalations of 25 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily.
Danish: - To pust (50 mikrogram salmeterol og 100 mikrogram fluticasonpropionat) to gange daglig.
English: Patients should shake the inhaler well.
Danish: Sprayen skal holdes lodret under inhalationen.
English: Viani Evohaler and associated names (see Annex I) 25/250 microgram/dose pressurised inhalation, suspension [See Annex I - To be completed nationally]
Danish: Viani Evohaler og andre navne (se bilag I) 25/250 mikrogram/dosis inhalationsspray [Se bilag I - Udfyldes nationalt]
English: Viani Evohaler and associated names (see Annex I) 25/50 microgram/dose pressurised inhalation, suspension [See Annex I - To be completed nationally]
Danish: Viani Evohaler og andre navne (se bilag I) 25/50 mikrogram/dosis inhalationsspray [Se bilag I - Udfyldes nationalt]
English: Patients should be made aware that Viani Evohaler must be used daily for optimum benefit, even when asymptomatic.
Danish: For at opnå fuld effekt skal Viani tages hver dag - også i perioder uden symptomer.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Viani Evohaler and associated names (see Annex I) 25/125 microgram/dose pressurised inhalation, suspension [See Annex I - To be completed nationally]
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER INDGIVELSESVEJ(E) Viani Evohaler og andre navne (se bilag I) 25/125 mikrogram/dosis inhalationsspray {(sær)navn og tilhørende navne (Se bilag I) styrke lægemiddelform} [Se bilag I - Udfyldes nationalt]
English: Two inhalations of 25 micrograms salmeterol and 50 micrograms fluticasone propionate twice daily.
Danish: Her er den anbefalede dosis 50 mikrogram salmeterol og 100 mikrogram fluticasonpropionat 2 gange daglig.
English: The respective mechanisms of action of both drugs are discussed below.
Danish: En liste over alle hjælpestoffer er anført under.
English: If using your inhaler for the first time, remove the mouthpiece cover by holding the sides of the inhaler with your thumb and forefinger.
Danish: Tag beskyttelseshætten af ved at klemme let om siderne med tommel- og pegefinger og træk den af.
English: Pharmacotherapeutic Group: Adrenergics and other anti-asthmatics.
Danish: Farmakoterapeutisk klassifikation: Astmamiddel med bronkodilaterende og antiinflammatorisk virkning beregnet til inhalation, R 03 AK 06
English: Viani 25/50 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: Det anbefales at finde den mest hensigtsmæssige dosis inhalationssteroid, før der anvendes en fast kombination hos patienter med svær astma.
English: After use, always replace the mouthpiece cover immediately to keep out dust.
Danish: Tryk beskyttelseshætten på med et klik lige efter inhalationen for at holde støv ude.
English: Testing the inhaler
Danish: Kun til inhalation.
English: FURTHER INFORMATION
Danish: Total Kontrol
English: The canister contains a white to off white suspension.
Danish: Suspensionen er hvidlig.
English: 1 x 120 actuations Inhaler or 3 x 120 actuations Inhaler or 10 x 120 actuations Inhaler - hospital/pharmacy use only (for dispensing purposes) Not all pack sizes may be marketed.
Danish: 10 x 120 doser (kun til hospitals- og apoteksbrug)
English: Viani 25/125 Evohaler
Danish: Viani 25/125 Evohaler To pust to gange daglig
English: Not applicable.
Danish: ANVENDELSESMÅDE Omrystes.
English: No ICS (SABA alone)
Danish: Ingen inhalationssteroid (kun anfaldsmedicin)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 120 puffs
Danish: UDLØBSDATO Anvendes senest BATCHNUMMER Batch no INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER [Udfyldes nationalt] 120 pust ANDET
English: Rue du Tilleul 13
Danish: KG Theresienhohe 11
English: While holding their breath, patients should take the inhaler from their mouth and take their finger from the top of the inhaler.
Danish: Patienten skal holde vejret i 5-10 sekunder og fjerne sprayen fra munden.
English: Therefore, it must be taken every day as directed by your doctor.
Danish: For at få kontrol over din astma skal du tage Viani hver dag som anvist af din læge.
English: The study was completed on 31 July 2016.
Danish: Undersøgelsen var gennemført den 31. juli 2016.
English: Co-administration should be avoided.
Danish: Koadministration bør undgås.
English: Height and weight showed similar improvements.
Danish: Højde og vægt viste tilsvarende forbedringer.
English: The remaining 5 patients were treatment naïve.
Danish: De resterende 5 patienter var behandlingsnaive.
English: The dose should be adjusted accordingly, as described above.
Danish: Dosis tilpasses i henhold hertil som beskrevet ovenfor.
English: Never take a double dose to make up for a forgotten dose.
Danish: Tag aldrig en dobbeltdosis som erstatning for den glemte dosis.
English: Liver parameters should also be monitored.
Danish: Også leverparametrene bør overvåges.
English: DATE OF FIRST AUTHORISATION 20 November 2015
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE 20 November 2015
English: There are also links to other websites about rare diseases and treatments.
Danish: Der er desuden links til websites om sjældne sygdomme og deres behandling.
English: The physician's educational material should contain the following key elements:
Danish: Informationsmaterialet for læger skal indeholde følgende hovedelementer:
English: Do not take more capsules than your doctor has advised you.
Danish: Tag ikke flere kapsler, end lægen har sagt til dig.
English: Once the bottle is opened, the medicinal product must be used within 3 months.
Danish: Efter anbrud af flasken skal lægemidlet anvendes inden tre måneder.
English: Your doctor will tell you how many capsules you need to take, and when you should take the capsules.
Danish: Lægen vil fortælle dig, hvor mange kapsler du skal tage, og hvornår du skal tage dem.
English: Do not chew the capsule.
Danish: Tyg ikke kapslen.
English: Swallow each capsule whole with water, either just before or just after food.
Danish: Synk hver kapsel hel med vand, enten lige før eller lige efter et måltid.
English: Take the next dose as soon as you remember, as long as it is more than 12 hours until the next dose.
Danish: Tag næste dosis så snart du kommer i tanker om det, forudsat at der er mere end 12 timer til næste dosis.
English: If not, the next higher dose should be selected.
Danish: Hvis ikke, vælges nærmeste højere dosis.
English: Dublin 2, Ireland Tel: +353 86 803 8014 info@retrophin.com
Danish: Tlf.: +353 86 803 8014 info@retrophin.com
English: - PSURs - Annual Reassessments
Danish: - PSUR - Årlige revurderinger
English: In the event of overdose the patient should be monitored and treated symptomatically.
Danish: Ved overdosering bør patienten overvåges og behandles symptomatisk.
English: There are several enzyme defects described in the literature.
Danish: Der er beskrevet flere enzymdefekter i litteraturen.
English: • Information on: o Calculation of the correct dose and the need to instruct caregivers on how to administer the product correctly o Symptoms and signs of an overdose and the management of this
Danish: • Oplysninger om: o Beregning af korrekt dosis og nødvendigheden af at instruere omsorgsgivere om, hvordan produktet administreres korrekt o Symptomer og tegn på overdosis og behandlingen heraf
English: In the absence of clinical experience in such patients, no recommendations on dosage adjustment can be made.
Danish: I mangel af kliniske erfaringer med disse patienter kan der ikke gives anbefalinger for dosisjustering.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Do not chew.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Må ikke tygges.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Danish: Dette er en godkendelse under særlige omstændigheder, og i henhold til artikel 14, stk. 8, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme udføre følgende foranstaltninger/tiltag:
English: More frequent tests will be needed if you are growing fast, if you are ill (e.g., if you have liver problems) or if you are pregnant.
Danish: Der skal tages prøver oftere, hvis du vokser hurtigt, er syg (f.eks. hvis du har leverproblemer) eller gravid.
English: See above under ‘Do not take Kolbam'.
Danish: Se ovenfor under ”Tag ikke Kolbam”.
English: <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: 1/1 000), meget sjælden (< 1/10 000), ikke kendt (kan ikke beregnes af foreliggende data).
English: Patients should be monitored initially every 3 months during the first year then 6 monthly during the subsequent three years and annually thereafter.
Danish: I det første år bør patienterne initialt monitoreres hver 3. måned, i de følgende tre år hver 6. måned, og derefter én gang årligt.
English: Kolbam can be used from the age of one month and patients affected by these conditions will need treatment for the rest of their life.
Danish: Kolbam kan anvendes fra en alder af 1 måned, og patienter med disse sygdomme har behov for behandling resten af livet.
English: The dose should be subsequently titrated to the desired effect but should not exceed a maximum of 15 mg/kg/day.
Danish: Dosis bør efterfølgende titreres til ønsket virkning, men bør ikke overstige 15 mg/kg/dag.
English: The capsule contents will remain as fine granules in the milk or food.
Danish: Kapselindholdet vil forblive til stede som fine korn i mælken eller maden.
English: In all studies, a dose of 10-15 mg/kg/day was administered.
Danish: I alle undersøgelserne blev der givet en dosis på 10-15 mg/kg/dag.
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares over 30° C.
English: What you need to know before you use Kolbam 3.
Danish: Det skal du vide, før du begynder at bruge Kolbam 3.
English: Progress and results from the registry will form the basis of the annual reassessments of the benefit/risk profile of Kolbam.
Danish: Forløbet og resultaterne fra databasen skal danne grundlag for de årlige revurderinger af Kolbam's benefit/risk-profil.
English: Clinical features were limited to pruritus and diarrhoea.
Danish: De kliniske kendetegn var begrænset til pruritus og diarré.
English: The mixture should be given immediately after preparation.
Danish: Blandingen skal gives straks efter tilberedningen.
English: Treatment must be initiated and monitored by physicians, including paediatricians, experienced in the management of the specific deficiencies.
Danish: Behandlingen skal initieres og monitoreres af læger, herunder pædiatere, med erfaring i behandling af disse specifikke mangler.
English: Cholic acid also promotes normal growth of children.
Danish: Cholsyre fremmer desuden normal vækst hos børn.
English: The capsules contain a white powder.
Danish: Kapslerne indeholder et hvidt pulver.
English: Do not use after the expiry date which is stated on the carton and bottle label after “EXP''.
Danish: Brug ikke Kolbam efter den udløbsdato, der står på pakningen efter ”EXP”.
English: Use in adults
Danish: Anvendelse til voksne
English: During your treatment, your doctor will carry out various blood and urine tests at different times to see how your body is handling this medicine and to help work out the dose that you need.
Danish: Under behandlingen vil lægen tage en række prøver af blod og urin på forskellige tidspunkter for at se, hvordan din krop håndtere lægemidlet, og for at beregne den dosis, du har behov for.
English: A total of 85 patients took part in the clinical study.
Danish: I undersøgelsen deltog i alt 85 patienter.
English: Side effects of unknown frequency (cannot be estimated from the available data):
Danish: Bivirkninger med ukendt hyppighed (kan ikke vurderes ud fra de foreliggende oplysninger):
English: Common side effects (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (forekommer hos indtil 1 ud af 10 behandlede)
English: It is important to give the full content of the capsule to the baby or young child where whole capsules cannot be given.
Danish: Det er vigtigt, at hele kapslens indhold gives til spædbarnet eller det lille barn, der ikke kan synke hele kapsler.
English: For additional information, see section 6.6.
Danish: 6.6 for yderligere oplysninger.
English: Should the use of a preparation containing one of these substances be necessary, it must be taken at least 5 hours before or after cholic acid.
Danish: Ved behov for et præparat indeholdende et af disse stoffer skal dette tages mindst 5 timer før eller efter cholsyre.
English: • lipid-lowering medicines such as clofibrate
Danish: • lipidsænkende lægemidler såsom clofibrat
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge lægen eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: The MAH shall ensure that at launch all physicians expected to prescribe the product are provided with information on the correct and safe use of the product.
Danish: Indehaveren af markedsføringstilladelsen sørger for, at alle læger, der forventes at ordinere produktet, ved lanceringen får udleveret information om korrekt og sikker anvendelse af produktet.
English: In this set of patients, about one quarter were below or at most 6 months of age at diagnosis, and about one third were between 7 and 36 months.
Danish: Af disse patienter var ca. en fjerdedel på diagnosetidspunktet højst 6 måneder, og ca. en tredjedel var mellem 7 og 36 måneder.
English: This medicine is intended for long-term use.
Danish: Dette lægemiddel er beregnet til langtidsbehandling.
English: Patheon France 40 boulevard de champaret 38300 Bourgoin-Jallieu France
Danish: Patheon France 40 boulevard de champaret 38300 Bourgoin-Jallieu Frankrig
English: On average, patients in this subgroup were 3 years at treatment start, minimum and maximum ages were 0 and 14 years, respectively.
Danish: I gennemsnit var patienterne i denne undergruppe 3 år gamle ved behandlingens påbegyndelse, og den yngste og ældste var henholdsvis 0 og 14 år.
English: This medicinal product has been authorised under ‘exceptional circumstances,' which means that, due to the rarity of the disease and for ethical reasons, it has not been possible to obtain complete information on this medicinal product.
Danish: Dette lægemiddel er godkendt under “særlige omstændigheder”, hvilket betyder, at det ikke har været muligt at opnå fuldstændig dokumentation for dette lægemiddel, som følge af sygdommens sjældenhed og af etiske grunde.
English: You can continue to breastfeed your baby whilst being treated with cholic acid, as levels in breast milk are considered too low to harm your baby.
Danish: Du kan fortsætte med at amme dit barn, mens du er i behandling med cholsyre, da indholdet i modermælk anses for at være for lavt til at kunne skade dit barn.
English: Your doctor will advise you if for any reason you have to stop treatment with cholic acid.
Danish: Lægen vil fortælle dig det, hvis du af en eller anden grund skal stoppe med behandlingen med cholsyre.
English: The recommended dose is based on your body weight (10-15 mg per kg) taken either as a single dose, once a day, or divided into two doses, one in the morning and one in the evening.
Danish: Den anbefalede dosis er baseret på din legemsvægt (10-15 mg per kg), enten som en enkelt dosis, én gang dagligt, eller fordelt på to doser, en om morgenen og en om aftenen.
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal derefter fremsende PSUR'er i overensstemmelse med kravene på listen over EU-referencedatoer (EURD-listen), som fastsat i artikel 107c (7) i direktiv 2001/83/EC og offentliggjort på den europæiske webportal for lægemidler.
English: Use in the paediatric population
Danish: Anvendes til den pædiatriske population
English: Episodes of symptomatic overdose (or excessive dosing regimen) have been reported, including accidental overdose.
Danish: Der er beskrevet episoder med symptomgivende overdosering (eller forhøjet dosisregime), herunder utilsigtet overdosering.
English: In Study CAC-002-01, the mean age of patients at baseline was 9.0 years, with ages ranging from 0.1 to 35.6 years.
Danish: I undersøgelse CAC-002-01 var patienternes gennemsnitsalder ved baseline 9,0 år med variationsbredde 0,1 til 35,6 år.
English: Your doctor will advise you to take cholic acid at least 5 hours before or after taking the other medicine.
Danish: Lægen vil instruere dig om, at du skal tage cholsyre mindst 5 timer før eller efter anden medicin.
English: Cholic acid is unlikely to cause serious side effects but you should contact your doctor for advice if you or your child have taken more than the amount prescribed.
Danish: Cholsyre vil næppe medføre alvorlige bivirkninger, men forhør dig hos lægen, hvis du eller dit barn har taget mere end den mængde, der er ordineret.
English: At therapeutic doses, no effect on fertility is anticipated.
Danish: Ved terapeutiske doser forventes ingen virkning på fertiliteten.
English: The dose of cholic acid should be adjusted individually.
Danish: Dosis af cholsyre bør tilpasses individuelt.
English: Reports on recruitment progress of the registry will be submitted with PSURs and Annual Re-assessments.
Danish: Oplysninger om rekrutteringsforløbet for registret skal forelægges sammen med PSUR og årlige revurderinger.
English: However, these patients should be carefully monitored and the dose of cholic acid titrated individually.
Danish: Sådanne patienter bør imidlertid overvåges omhyggeligt, og dosis af cholsyre titreres individuelt.
English: France
Danish: Irland