natgillin/translations-raw huggingface dataset:
Da brugen af spacer sammen med inhalationssprayen kan øge mængden af det aktive stof i lungerne, kan det eventuelt føre til øget risiko for systemiske bivirkninger, idet den systemiske absorption hovedsageligt sker gennem lungerne. 
As systemic absorption is largely through the lungs, the use of a spacer plus metered dose inhaler may increase drug delivery to the lungs.
Lav dosis inhalationssteroid (≤ 500mikg beclometasondipropionat eller tilsvarende/dgl.) 
Low dose ICS ( ≤500mcg BDP or equivalent/day)
Hvis inhalationssprayen ikke har været brugt i en uge eller længere, rystes den omhyggeligt, og to pust trykkes ud i luften. 
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.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) Udfyldes nationalt DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Udfyldes nationalt 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
4, 5 og 6. 
Patients should not rush stages 4, 5 and 6.
Klem på siderne af beskyttelseshætten med tommel- og pegefinger og træk den forsigtigt af. 
To remove the mouthpiece cover, hold the sides of the inhaler with your thumb and forefinger, squeeze the cover gently and pull apart.
Patienter med astma, som i løbet af et år blev velkontrolleret*) eller hvor Total Kontrol**) blev opnået Salmeterol/fluticasonpropionat 
Percentage of Patients Attaining *Well Controlled (WC) and **Totally Controlled (TC) Asthma over 12 months
Prøv ikke at ændre på dosistælleren eller på anden måde at øve vold på den. 
Never try to alter the numbers on the counter or detach the counter from the metal can.
Som med anden inhalationsmedicin bør sprayen ikke være kold på anvendelsestidspunktet, da det kan forringe den terapeutiske effekt. 
As with most inhaled medicinal products in pressurised containers, the therapeutic effect of this medicinal product may decrease when the container is cold.
Sørg for, at mundstykket er rent både indvendigt og udvendigt. 
Check inside and outside to make sure that the mouthpiece is clean and that there are no foreign objects.
1, 3 eller 10 x Evohaler. 
The devices are packed in cartons of 1, 3 or 10 Evohalers.
Tryk beholderen ned i starten af en indånding gennem munden og inhalér dosis roligt og dybt. 
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.
Bivirkningerne er inddelt i henhold til organklasser og efter hyppighed. 
Adverse events which have been associated with salmeterol/fluticasone propionate are given below, listed by system organ class and frequency.
Ryst sprayen. 
Pressurised container.
Inhalationsspray leveres I æsker med: 
The devices are available in cardboard containers, which hold:
Salmeterol 25 mikrogram som salmeterolxinafoat og 50 mikrogram, 125 mikrogram eller 250 mikrogram fluticasonpropionat. 
25 micrograms of salmeterol (as salmeterol xinafoate) and 50, 125 or 250 micrograms of fluticasone propionate (delivered from the valve).
Tryk nogle pust ud i luften, indtil dosistælleren står på 120, for at sikre, at den virker ordentligt. 
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.
Beholderen skal trykkes ned i starten af en indånding gennem munden, og dosis inhaleres roligt og dybt. 
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.
Viani bør gives med forsigtighed ved alvorlige hjerte-kar-sygdomme, inkl. 
Viani should be administered with caution in patients with severe cardiovascular disorders, including heart rhythm abnormalities, diabetes mellitus, untreated hypokalaemia or thyrotoxicosis.
Viani inhalationsspray er en suspension, som skal omrystes før brug. 
Viani is supplied to you in a metered dose inhaler which delivers your medicine in a pressurised suspension for you to inhale.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Salmeterol som salmeterolxinafoat 25 mikrogram og fluticasonpropionat 125 mikrogram pr. dosis 
STATEMENT OF ACTIVE SUBSTANCE(S) 25 micrograms of salmeterol (as xinafoate) and 125 micrograms of fluticasone propionate per actuation
Pust helt ud. 
Breathe out as far as is comfortable.
Der bør udvises forsigtighed ved lungetuberkulose, som ved al anden inhalationsbehandling med kortikosteroider. 
Consideration should be given to additional corticosteroid therapies.
Patienten skal instrueres godt i, hvordan sprayen skal bruges, som beskrevet i indlægssedlen i pakningen. 
METHOD OF ADMINISTRATION Shake well before use Read the package leaflet before use
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Salmeterol som salmeterolxinafoat 25 mikrogram og fluticasonpropionat 50 mikrogram pr. dosis 
STATEMENT OF ACTIVE SUBSTANCE(S) 25 micrograms of salmeterol (as xinafoate) and 50 micrograms of fluticasone propionate per actuation
Da noget af indholdet aflejres i sprayen, reduceres inhalationen til 21 mikrogram salmeterol og hhv. 44, 110 og 220 mikrogram fluticasonpropionat. 
This is equivalent to 21 micrograms of salmeterol and 44, 110 or 220 micrograms of fluticasone propionate delivered from the actuator (delivered dose).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Salmeterol som salmeterolxinafoat 25 mikrogram og fluticasonpropionat 250 mikrogram pr. dosis 
STATEMENT OF ACTIVE SUBSTANCE(S) 25 micrograms of salmeterol (as xinafoate) and 250 micrograms of fluticasone propionate per actuation
Viani Evohaler og andre navne (se bilag I) 25/125 mikrogram/dosis inhalationsspray [Se bilag I - Udfyldes nationalt] 
Viani Evohaler and associated names (see Annex I) 25/125 microgram/dose pressurised inhalation, suspension [See Annex I - To be completed nationally]
- To pust (50 mikrogram salmeterol og 100 mikrogram fluticasonpropionat) to gange daglig. 
Two inhalations of 25 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily.
Sprayen skal holdes lodret under inhalationen. 
Patients should shake the inhaler well.
Viani Evohaler og andre navne (se bilag I) 25/250 mikrogram/dosis inhalationsspray [Se bilag I - Udfyldes nationalt] 
Viani Evohaler and associated names (see Annex I) 25/250 microgram/dose pressurised inhalation, suspension [See Annex I - To be completed nationally]
Viani Evohaler og andre navne (se bilag I) 25/50 mikrogram/dosis inhalationsspray [Se bilag I - Udfyldes nationalt] 
Viani Evohaler and associated names (see Annex I) 25/50 microgram/dose pressurised inhalation, suspension [See Annex I - To be completed nationally]
For at opnå fuld effekt skal Viani tages hver dag - også i perioder uden symptomer. 
Patients should be made aware that Viani Evohaler must be used daily for optimum benefit, even when asymptomatic.
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] 
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]
Her er den anbefalede dosis 50 mikrogram salmeterol og 100 mikrogram fluticasonpropionat 2 gange daglig. 
Two inhalations of 25 micrograms salmeterol and 50 micrograms fluticasone propionate twice daily.
En liste over alle hjælpestoffer er anført under. 
The respective mechanisms of action of both drugs are discussed below.
Tag beskyttelseshætten af ved at klemme let om siderne med tommel- og pegefinger og træk den af. 
If using your inhaler for the first time, remove the mouthpiece cover by holding the sides of the inhaler with your thumb and forefinger.
Farmakoterapeutisk klassifikation: Astmamiddel med bronkodilaterende og antiinflammatorisk virkning beregnet til inhalation, R 03 AK 06 
Pharmacotherapeutic Group: Adrenergics and other anti-asthmatics.
Det anbefales at finde den mest hensigtsmæssige dosis inhalationssteroid, før der anvendes en fast kombination hos patienter med svær astma. 
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.
Tryk beskyttelseshætten på med et klik lige efter inhalationen for at holde støv ude. 
After use, always replace the mouthpiece cover immediately to keep out dust.
Kun til inhalation. 
Testing the inhaler
Total Kontrol 
FURTHER INFORMATION
Suspensionen er hvidlig. 
The canister contains a white to off white suspension.
10 x 120 doser (kun til hospitals- og apoteksbrug) 
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.
Viani 25/125 Evohaler To pust to gange daglig 
Viani 25/125 Evohaler
ANVENDELSESMÅDE Omrystes. 
Not applicable.
Ingen inhalationssteroid (kun anfaldsmedicin) 
No ICS (SABA alone)
UDLØBSDATO Anvendes senest BATCHNUMMER Batch no INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER [Udfyldes nationalt] 120 pust ANDET 
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 120 puffs
Patienten skal holde vejret i 5-10 sekunder og fjerne sprayen fra munden. 
While holding their breath, patients should take the inhaler from their mouth and take their finger from the top of the inhaler.
For at få kontrol over din astma skal du tage Viani hver dag som anvist af din læge. 
Therefore, it must be taken every day as directed by your doctor.
Undersøgelsen var gennemført den 31. juli 2016. 
The study was completed on 31 July 2016.
Koadministration bør undgås. 
Co-administration should be avoided.
Højde og vægt viste tilsvarende forbedringer. 
Height and weight showed similar improvements.
De resterende 5 patienter var behandlingsnaive. 
The remaining 5 patients were treatment naïve.
Dosis tilpasses i henhold hertil som beskrevet ovenfor. 
The dose should be adjusted accordingly, as described above.
Tag aldrig en dobbeltdosis som erstatning for den glemte dosis. 
Never take a double dose to make up for a forgotten dose.
Også leverparametrene bør overvåges. 
Liver parameters should also be monitored.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE 20 November 2015 
DATE OF FIRST AUTHORISATION 20 November 2015
Der er desuden links til websites om sjældne sygdomme og deres behandling. 
There are also links to other websites about rare diseases and treatments.
Informationsmaterialet for læger skal indeholde følgende hovedelementer: 
The physician's educational material should contain the following key elements:
Tag ikke flere kapsler, end lægen har sagt til dig. 
Do not take more capsules than your doctor has advised you.
Efter anbrud af flasken skal lægemidlet anvendes inden tre måneder. 
Once the bottle is opened, the medicinal product must be used within 3 months.
Lægen vil fortælle dig, hvor mange kapsler du skal tage, og hvornår du skal tage dem. 
Your doctor will tell you how many capsules you need to take, and when you should take the capsules.
Tyg ikke kapslen. 
Do not chew the capsule.
Synk hver kapsel hel med vand, enten lige før eller lige efter et måltid. 
Swallow each capsule whole with water, either just before or just after food.
Tag næste dosis så snart du kommer i tanker om det, forudsat at der er mere end 12 timer til næste dosis. 
Take the next dose as soon as you remember, as long as it is more than 12 hours until the next dose.
Hvis ikke, vælges nærmeste højere dosis. 
If not, the next higher dose should be selected.
Tlf.: +353 86 803 8014 info@retrophin.com 
Dublin 2, Ireland Tel: +353 86 803 8014 info@retrophin.com
- PSUR - Årlige revurderinger 
- PSURs - Annual Reassessments
Ved overdosering bør patienten overvåges og behandles symptomatisk. 
In the event of overdose the patient should be monitored and treated symptomatically.
Der er beskrevet flere enzymdefekter i litteraturen. 
There are several enzyme defects described in the literature.
• 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 
• 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
I mangel af kliniske erfaringer med disse patienter kan der ikke gives anbefalinger for dosisjustering. 
In the absence of clinical experience in such patients, no recommendations on dosage adjustment can be made.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Må ikke tygges. 
METHOD AND ROUTE(S) OF ADMINISTRATION Do not chew.
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: 
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:
Der skal tages prøver oftere, hvis du vokser hurtigt, er syg (f.eks. hvis du har leverproblemer) eller gravid. 
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.
Se ovenfor under ”Tag ikke Kolbam”. 
See above under ‘Do not take Kolbam'.
1/1 000), meget sjælden (< 1/10 000), ikke kendt (kan ikke beregnes af foreliggende data). 
<1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
I det første år bør patienterne initialt monitoreres hver 3. måned, i de følgende tre år hver 6. måned, og derefter én gang årligt. 
Patients should be monitored initially every 3 months during the first year then 6 monthly during the subsequent three years and annually thereafter.
Kolbam kan anvendes fra en alder af 1 måned, og patienter med disse sygdomme har behov for behandling resten af livet. 
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.
Dosis bør efterfølgende titreres til ønsket virkning, men bør ikke overstige 15 mg/kg/dag. 
The dose should be subsequently titrated to the desired effect but should not exceed a maximum of 15 mg/kg/day.
Kapselindholdet vil forblive til stede som fine korn i mælken eller maden. 
The capsule contents will remain as fine granules in the milk or food.
I alle undersøgelserne blev der givet en dosis på 10-15 mg/kg/dag. 
In all studies, a dose of 10-15 mg/kg/day was administered.
SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares over 30° C. 
SPECIAL STORAGE CONDITIONS Do not store above 30°C.
Det skal du vide, før du begynder at bruge Kolbam 3. 
What you need to know before you use Kolbam 3.
Forløbet og resultaterne fra databasen skal danne grundlag for de årlige revurderinger af Kolbam's benefit/risk-profil. 
Progress and results from the registry will form the basis of the annual reassessments of the benefit/risk profile of Kolbam.
De kliniske kendetegn var begrænset til pruritus og diarré. 
Clinical features were limited to pruritus and diarrhoea.
Blandingen skal gives straks efter tilberedningen. 
The mixture should be given immediately after preparation.
Behandlingen skal initieres og monitoreres af læger, herunder pædiatere, med erfaring i behandling af disse specifikke mangler. 
Treatment must be initiated and monitored by physicians, including paediatricians, experienced in the management of the specific deficiencies.
Cholsyre fremmer desuden normal vækst hos børn. 
Cholic acid also promotes normal growth of children.
Kapslerne indeholder et hvidt pulver. 
The capsules contain a white powder.
Brug ikke Kolbam efter den udløbsdato, der står på pakningen efter ”EXP”. 
Do not use after the expiry date which is stated on the carton and bottle label after “EXP''.
Anvendelse til voksne 
Use in adults
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. 
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.
I undersøgelsen deltog i alt 85 patienter. 
A total of 85 patients took part in the clinical study.
Bivirkninger med ukendt hyppighed (kan ikke vurderes ud fra de foreliggende oplysninger): 
Side effects of unknown frequency (cannot be estimated from the available data):
Almindelige bivirkninger (forekommer hos indtil 1 ud af 10 behandlede) 
Common side effects (may affect up to 1 in 10 people)
Det er vigtigt, at hele kapslens indhold gives til spædbarnet eller det lille barn, der ikke kan synke hele kapsler. 
It is important to give the full content of the capsule to the baby or young child where whole capsules cannot be given.
6.6 for yderligere oplysninger. 
For additional information, see section 6.6.
Ved behov for et præparat indeholdende et af disse stoffer skal dette tages mindst 5 timer før eller efter cholsyre. 
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.
• lipidsænkende lægemidler såsom clofibrat 
• lipid-lowering medicines such as clofibrate
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. 
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.
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. 
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.
Af disse patienter var ca. en fjerdedel på diagnosetidspunktet højst 6 måneder, og ca. en tredjedel var mellem 7 og 36 måneder. 
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.
Dette lægemiddel er beregnet til langtidsbehandling. 
This medicine is intended for long-term use.
Patheon France 40 boulevard de champaret 38300 Bourgoin-Jallieu Frankrig 
Patheon France 40 boulevard de champaret 38300 Bourgoin-Jallieu France
I gennemsnit var patienterne i denne undergruppe 3 år gamle ved behandlingens påbegyndelse, og den yngste og ældste var henholdsvis 0 og 14 år. 
On average, patients in this subgroup were 3 years at treatment start, minimum and maximum ages were 0 and 14 years, respectively.
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. 
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.
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. 
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.
Lægen vil fortælle dig det, hvis du af en eller anden grund skal stoppe med behandlingen med cholsyre. 
Your doctor will advise you if for any reason you have to stop treatment with cholic acid.
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. 
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.
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. 
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.
Anvendes til den pædiatriske population 
Use in the paediatric population
Der er beskrevet episoder med symptomgivende overdosering (eller forhøjet dosisregime), herunder utilsigtet overdosering. 
Episodes of symptomatic overdose (or excessive dosing regimen) have been reported, including accidental overdose.
I undersøgelse CAC-002-01 var patienternes gennemsnitsalder ved baseline 9,0 år med variationsbredde 0,1 til 35,6 år. 
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.
Lægen vil instruere dig om, at du skal tage cholsyre mindst 5 timer før eller efter anden medicin. 
Your doctor will advise you to take cholic acid at least 5 hours before or after taking the other medicine.
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. 
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.
Ved terapeutiske doser forventes ingen virkning på fertiliteten. 
At therapeutic doses, no effect on fertility is anticipated.
Dosis af cholsyre bør tilpasses individuelt. 
The dose of cholic acid should be adjusted individually.
Oplysninger om rekrutteringsforløbet for registret skal forelægges sammen med PSUR og årlige revurderinger. 
Reports on recruitment progress of the registry will be submitted with PSURs and Annual Re-assessments.
Sådanne patienter bør imidlertid overvåges omhyggeligt, og dosis af cholsyre titreres individuelt. 
However, these patients should be carefully monitored and the dose of cholic acid titrated individually.
Irland 
France
Cholsyre er hos mennesket en af de primære galdesyrer, som essentielle fysiologiske funktioner afhænger af. 
Cholic acid is one of the primary bile acids in man on which essential physiological functions depend.
Før markedsføring i hver medlemsstat skal indehaveren af markedsføringstilladelsen træffe aftale om det endelige uddannelsesprogram med de nationale kompetente myndigheder. 
Prior to launch in each Member State, the MAH shall agree the final educational material with the competent authority in that Member State.
Hvis du holder op med at tage Kolbam 
If you stop taking Kolbam
Nogle af de primære defekter er bl.a.: 
Some of the primary defects include but are not limited to:
Der er ikke udført interaktionsundersøgelser med cholsyre og samtidigt administrerede lægemidler eller fødemidler. 
No interaction studies with cholic acid and concomitantly administered medicinal products or food have been carried out.
Må ikke opbevares over 30° C. 
Do not store above 30°C.
Overvågning af den langsigtede sikkerhed og virkning hos patienter behandlet med Kolbam gennem et patientregister, som nærmere beskrives i risikostyringsplanen. 
To monitor the long term safety and efficacy in patients treated with Kolbam from a patient registry for which details are reflected in the risk management plan.
Bivirkningerne var forbigående og medførte sædvanligvis ikke ændringer i behandlingen. 
The events were transitory and generally did not interfere with the therapy.