natgillin/translations-raw huggingface dataset:
Viani Evohaler og tilknyttede navne (se bilag I til udtalelsen) indeholder salmeterol og fluticasonpropionat, som er en fastdosiskombination af den langtidsvirkende beta-agonist salmeterol og det inhalerede corticosteroid fluticasonpropionat, der er indiceret til standardbehandling af astma, når det er hensigtsmæssigt at anvende et kombinationsprodukt (langtidsvirkende beta-2-agonist og inhaleret corticosteroid): - hos patienter, som ikke kan kontrolleres tilstrækkeligt med inhalerede corticosteroider og inhaleret korttidsvirkende beta-2-agonist givet efter behov, eller - hos patienter, der allerede kontrolleres tilstrækkeligt med både inhaleret corticosteroid og langtidsvirkende beta-2agonist.
Viani Evohaler and associated names (see Annex I of Opinion) contain salmeterol and fluticasone propionate, a fixed dose combination of the long acting β-agonist (LABA) salmeterol and the inhaled corticosteroid (ICS) fluticasone propionate (FP) 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 - patients already adequately controlled on both inhaled corticosteroid and longacting beta-2-agonist.
Astmapatienter er i mindre grad udsat for systemisk påvirkning efter inhalation af fluticasonpropionat.
In patients with asthma a lesser degree of systemic exposure to inhaled fluticasone propionate has been observed.
Hovedparten udskilles i fæces som metabolitter eller uomdannet.
The main part of the dose is excreted as faeces as metabolites and unchanged drug.
Metalbeholderen må ikke komme i vand.
Do not put the metal container in water.
Den i afsnit 4.2 indføjede anbefaling giver mulighed for kortvarig forsøgsvis brug af Viani Evohaler hos voksne patienter med moderat persisterende astma og tvingende behov for hurtig astmakontrol.
The recommendation included in section 4.2 allows a short term trial of Viani Evohaler in adults and adolescents with moderate persistent asthma for whom rapid control of asthma is essential.
Patienten skal puste helt ud og derefter placere mundstykket mellem tænderne og lad læberne slutte tæt omkring det uden at bide i det.
Patients should breathe out as far as is comfortable and then place the mouthpiece in your mouth between their teeth and close their lips around it, Patients should be instructed not to bite the mouth piece.
Inhalationsspray, suspension.
Pressurised inhalation, suspension.
Du skal helst sidde eller stå op, når du bruger din spray.
You should be standing or sitting whilst using the inhaler.
Du bør ikke anvende Viani - hvis du lider af hjertesygdomme, herunder uregelmæssig eller hurtig hjertebanken, eller forøget hormonproduktion fra skjoldbruskkirtlen, forhøjet blodtryk, sukkersyge (Viani kan forhøje dit blodsukker), lavt indhold af kalium i blodet, eller hvis du er eller har været i behandling for tuberkulose (tb).
Your doctor will supervise your treatment more closely if you have medical conditions such as heart disease including an irregular or fast heart beat, overactive thyroid gland, high blood pressure, diabetes mellitus (Viani may increase your blood sugar), low potassium in your blood or if you are being, or have been treated for have tuberculosis (TB).
Beholderen er forsynet med en dosistæller, som viser, hvor mange doser, der er tilbage.
The canister has a counter attached to it, which shows how many actuations of medicine are left.
Lægen skal være opmærksom på, at hos astmapatienter er fluticasonpropionat dobbelt så effektivt som andre steroider til inhalation.
Prescribers should be aware that, in patients with asthma, fluticasone propionate is as effective as other inhaled steroids at approximately half the microgram daily dose.
I så fald skal Viani straks seponeres, patienten undersøges, og om nødvendigt gives anden behandling.
Viani Evohaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Øget brug af korttidsvirkende bronkodilatatorer betyder forværring, og patientens tilstand bør revurderes af en læge.
Increasing use of short-acting bronchodilators to relieve asthma symptoms indicates deterioration of asthma control and patients should be reviewed by a physician.
GlaxoSmithKline SA Parque Tecnologico de Madrid, Calle Severo Ochoa 2, 28760, Tres Cantos, Madrid, Spanien
GlaxoSmithKline SA Parque Tecnologico de Madrid, Calle Severo Ochoa 2, 28760 Tres Cantos, Madrid Spain
Brugen af spacer sammen med inhalationssprayen for større terapeutisk effekt anbefales til patienter (især små børn), som har svært ved samtidig at inhalere og aktivere sprayen (se pkt.
The use of a spacer device with the inhaler in order to derive greater therapeutic benefit is recommended for patients (in particular young children) who have difficulty co-ordinating inhalation with actuation (see section 4.4 Special Warnings and Precautions for use)
Din læge vil bestræbe sig på at ordinere den laveste dosis Viani Evohaler, som kan holde dine symptomer under kontrol.
The doctor will prescribe the lowest strength of Viani Evohaler that will best control your symptoms.
Hold sprayen lodret med tommelfingeren på basis under mundstykket.
Hold the inhaler upright with your thumb on the base, below the mouthpiece.
Skyl munden med vand og spyt ud - eller børst tænder - for at modvirke svamp og hæshed.
Rinse your mouth with water and spit it out as this may help prevent the occurrence of thrush and hoarseness.
Viani Evohaler Det Forenede Kongerige Viani Evohaler
Viani Evohaler United Kingdom Viani Evohaler
- Tør mundstykket indvendigt og udvendigt og tør plastichylstret med en tør klud.
- Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth or tissue.
Brug af inhalationsspray
Inhalation use
Hvis patienten får ordineret endnu et pust, skal sprayen holdes lodret, og der skal gå ½ minut, før pkt.
If patients are going to take a second puff they should keep the inhaler upright and wait about half a minute before repeating steps 2 to 6.
Det er blevet påvist ved daglig anvendelse igennem to år på en lang række forskellige dyrearter, at det tilsatte CFC-frie drivmiddel, norfluran, ikke har nogen toksisk effekt selv ved langt højere forstøvningskoncentrationer, end patienter sandsynligvis nogensinde vil få det.
The non-CFC propellant, Norflurane, has been shown to have no toxic effect at very high vapour concentrations, far in excess of those likely to be experienced by patients, in a wide range of animal species exposed daily for periods of two years.
Antal doser ses i et vindue i plastichylstret (dosistæller).
The number will show through a window in the back of the plastic actuator.
Viani må ikke opbevares koldt, da det kan forringe virkningen af medicinen.
Do not store Viani Evohaler in a cold place, as your medicine may not work as well.
Hvert pust indeholder 25 mikrogram salmeterol som salmeterolxinafoat sammen med 50, 125 eller 250 mikrogram fluticasonpropionat.
Each puff provides 25 micrograms of salmeterol (as xinafoate) together with either 50, 125 or 250 micrograms of fluticasone propionate.
Læs indlægssedlen inden brug.
Shake the inhaler before use.
Afprøvningsresultater:
Instructions for Use:
Hver dosis Viani indeholder:
QUALITATIVE AND QUANTITATIVE COMPOSITION Each single actuation of Viani provides:
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Udfyldes nationalt] [Se bilag I - Udfyldes nationalt]
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Både selektive og ikke-selektive ß-blokkere skal så vidt muligt undgås.
Both non-selective and selective beta-blockers should be avoided in patients with asthma, unless there are compelling reasons for their use.
**) Total kontrol blev defineret som: ingen symptomer, ingen brug af korttidsvirkende ß2-agonister (behovsmedicin), ≥ 80 % af forventet lungefunktion, ingen natlig opvågnen, ingen eksacerbationer og ingen bivirkninger, der førte til ændring i behandlingen.
Pooled results across the 3 treatment levels *Well controlled asthma; occasional symptoms or SABA use or less than 80% predicted lung function plus no night-time awakenings, no exacerbations and no side effects enforcing a change in therapy **Total control of asthma; no symptoms, no SABA use, greater than or equal to 80% predicted lung function, no night-time awakenings, no exacerbations and no side effects enforcing a change in therapy.
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.
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.
- Fjern beskyttelseshætten fra mundstykket.
- Remove the mouthpiece cover.
ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
LÆGEMIDDELFORM Inhalationsspray, suspension.
PHARMACEUTICAL FORM Pressurised inhalation, suspension.
Startdosis er 2 inhalationer af 25 mcg salmeterol/100 mcg fluticasonpropionat to gange dagligt.
The initial starting dose is 2 inhalations of 25 mcg salmeterol and 50 mcg FP twice daily.
Sprayen skal holdes lodret med tommelfingeren på basis under mundstykket.
Patients should hold the inhaler upright between fingers and thumb with their thumb on the base, below the mouthpiece.
Beholderen er monteret i plastichylster med mundstykke og beskyttelseshætte.
The containers are fitted into plastic actuators incorporating an atomising mouthpiece and fitted with dustcaps.
KLINISKE OPLYSNINGER 4.1 Terapeutiske indikationer Astma Til behandling af astma, hvor behandling med et kombinationsprodukt (langtidsvirkende ß2-agonist og inhalationssteroid) er hensigtsmæssig: - hos patienter, der ikke er velkontrollerede på inhalationssteroid og korttidsvirkende ß2-agonist ved behov,
CLINICAL PARTICULARS 4.1 Therapeutic indications 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 patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-agonist.
Moderat dosis inhalationssteroid (>5001000mikg beclometasondipropionat eller tilsvarende/dgl.)
Medium dose ICS (>500-1000mcg BDP or equivalent/day)
Før inhalationssprayen tages i brug første gang, rystes den omhyggeligt, og den trykkes af ud i luften, indtil dosistælleren står på 120.
Before using for the first time patients should remove the mouthpiece cover by gently squeezing the sides of the cover, shake the inhaler well, and release puffs into the air until the counter reads 120 to make sure that it works.
Anvendes senest
INSTRUCTIONS ON USE
Det øvrige indholdsstof er norfluran.
- The other ingredient is Norflurane (HFA 134a).
YDERLIGERE OPLYSNINGER Viani indeholder - De aktive stoffer er 25 mikrogram salmeterol som salmeterolxinafoat og 50, 125 eller 250 mikrogram fluticasonpropionat.
What Viani contains - The active substance(s) are 25 micrograms salmeterol (as xinafoate) and 50, 125 or 250
Produktets udseende og pakningstørrelse Inhalationsspray, suspension.
What Viani looks like and contents of the pack Pressurised inhalation, suspension.
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.