FrancophonIA/ELRC3.0 huggingface dataset:
English: However, do not use DuoResp Spiromax just before exercise to stop asthma symptoms from happening.
Danish: Du må imidlertid ikke bruge DuoResp Spiromax lige før, du dyrker motion, for at forhindre, at der opstår astmasymptomer.
English: DuoResp Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:
Danish: DuoResp Spiromax er indiceret til behandling af astma, hvor det er hensigtsmæssigt at anvende en kombination (inhaleret kortikosteroid og langtidsvirkende β2-agonist):
English: DuoResp Spiromax maintenance and reliever therapy: DuoResp Spiromax is taken as regular maintenance treatment and as needed in response to symptoms.
Danish: DuoResp Spiromax vedligeholdelses- og behovsbehandling: DuoResp Spiromax tages regelmæssigt som vedligeholdelsesbehandling og efter behov ved symptomer.
English: In pharmacokinetic studies with and without a charcoal blockage, DuoResp Spiromax was evaluated by comparing it with an alternative authorised fixed-dose combination inhaled product containing the same active substances, budesonide and formoterol and has been shown to be equivalent in both systemic exposure (safety) and pulmonary deposition (efficacy).
Danish: I farmakokinetiske studier med og uden blokade med medicinsk kul blev DuoResp Spiromax evalueret ved at sammenligne det med et andet godkendt inhalationspræparat med fastdosiskombination, der indeholdt de samme aktive indholdsstoffer, budesonid og formoterol.
English: Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of DuoResp Spiromax.
Danish: Når astmasymptomerne er under kontrol, kan det overvejes gradvist at reducere dosis af DuoResp Spiromax.
English: The safety and efficacy of DuoResp Spiromax in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
Danish: DuoResp Spiromax' sikkerhed og virkning hos børn i alderen 12 år og derunder og unge i alderen 1317 år er endnu ikke klarlagt.
English: Only use DuoResp Spiromax in this way if your doctor has told you to. Use your DuoResp Spiromax every day.
Danish: Brug kun DuoResp Spiromax på denne måde, hvis lægen har bedt dig om det.
English: Your doctor may increase this to 2 inhalations twice a day.
Danish: Din læge kan øge dette til 2 inhalationer 2 gange dagligt.
English: Contents of the pack and other information What DuoResp Spiromax contains
Danish: Pakningsstørrelser og yderligere oplysninger DuoResp Spiromax indeholder:
English: Patients should not be initiated on DuoResp Spiromax during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Danish: Patienter bør ikke starte behandling med DuoResp Spiromax under en eksacerbation eller ved signifikant eller akut forværring af astma.
English: Use your DuoResp Spiromax every day.
Danish: Brug DuoResp Spiromax hver dag.
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, apoteket eller sundhedspersonalet.
English: DuoResp Spiromax 320 micrograms/9 micrograms should be used as maintenance therapy only.
Danish: DuoResp Spiromax 320 mikrogram/9,0 mikrogram bør kun anvendes som vedligeholdelsesbehandling.
English: If you use more DuoResp Spiromax than you should, contact your doctor, pharmacist or nurse for advice.
Danish: Hvis du har brugt for meget DuoResp Spiromax, skal du kontakte lægen, apotekspersonalet eller sundhedspersonalet.
English: DuoResp Spiromax is NOT indicated for use in children 12 years of age and younger or adolescents 13 to 17 years of age.
Danish: DuoResp Spiromax er IKKE beregnet til brug hos børn under 12 år eller unge i alderen 13 til 17 år.
English: Each DuoResp Spiromax inhaler contains 60 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.
Danish: Hver DuoResp Spiromax inhalator indeholder 60 inhalationer og har en hvid hoveddel med et halvgennemsigtigt vinrødt låg til mundstykket.
English: • Antidepressant medicines such as monoamine oxidase inhibitors and those with similar properties (such as the antibiotic furazolidone and the chemotherapy medicine procarbazine).
Danish: • Antidepressiva, såsom monoaminoxidasehæmmere og lægemidler med tilsvarende egenskaber (såsom antibiotikummet furazolidon og lægemidlet procarbazin til kemoterapi).
English: DuoResp Spiromax is not an appropriate treatment for the adult patient with only mild asthma who is not adequately controlled with an inhaled corticosteroid and “as needed” inhaled short-acting β2 adrenoreceptor agonists.
Danish: DuoResp Spiromax er ikke en passende behandling til voksne patienter, som blot lider af mild astma, som ikke kontrolleres tilstrækkeligt med inhalationssteroid samt korttidsvirkende β2-agonist efter behov.
English: Each DuoResp Spiromax inhaler contains 120 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.
Danish: Hver DuoResp Spiromax inhalator indeholder 120 inhalationer og har en hvid hoveddel med et halvgennemsigtigt, vinrødt låg til mundstykket.
English: What you need to know before you use DuoResp Spiromax Do not use DuoResp Spiromax if:
Danish: Det skal du vide, før du begynder at bruge DuoResp Spiromax Brug ikke DuoResp Spiromax
English: DuoResp Spiromax is indicated for use in adults 18 years of age and older only.
Danish: DuoResp Spiromax er udelukkende beregnet til brug hos voksne i alderen 18 år og derover.
English: If you stop using DuoResp Spiromax
Danish: Hvis du holder op med at bruge DuoResp Spiromax
English: If you forget to use DuoResp Spiromax
Danish: Hvis du har glemt at bruge DuoResp Spiromax
English: • If you have been prescribed DuoResp Spiromax as your only inhaler, read the section called (B) Using
Danish: • Hvis du har fået ordineret DuoResp Spiromax som din eneste inhalator, skal du læse afsnittet
English: Also use DuoResp Spiromax as a ‘reliever inhaler' to treat asthma symptoms when they occur.
Danish: Brug også DuoResp Spiromax som anfaldsmedicin til behandling af astmasymptomer, når de forekommer.
English: Other medicines and DuoResp Spiromax
Danish: Brug af anden medicin sammen med DuoResp Spiromax
English: (A) Using DuoResp Spiromax and a separate ‘reliever inhaler'.
Danish: (A) Brug af DuoResp Spiromax og en særskilt inhalator med anfaldsmedicin.
English: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Ireland
Danish: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Irland Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Holland Teva Operations Poland Sp. z o.o.
English: Symptoms of adrenal gland suppression could be tiredness, weakness, stomach problems, including nausea, vomiting, pain and diarrhoea, darkening of the skin and weight loss.
Danish: Symptomer på binyreundertrykkelse kan være træthed, svaghed, maveproblemer, herunder kvalme, opkastning, smerter og diarré, mørkfarvning af huden og vægttab.
English: DuoResp Spiromax is indicated in adults 18 years of age and older only.
Danish: DuoResp Spiromax er indiceret til voksne fra og med 18 år.
English: (B) Using DuoResp Spiromax as your only asthma inhaler
Danish: (B) Brug af DuoResp Spiromax som din eneste astmainhalator
English: b) You may be prescribed DuoResp Spiromax as your only asthma inhaler.
Danish: b) Du kan få ordineret DuoResp Spiromax som din eneste astma-inhalator.
English: Preparing your new DuoResp Spiromax
Danish: Sådan klargør du din nye DuoResp Spiromax
English: DuoResp Spiromax 160 mcg/4.5 mcg
Danish: DuoResp Spiromax 160 mikrogram/4,5 mikrogram
English: DuoResp Spiromax 320 mcg/9 mcg
Danish: DuoResp Spiromax 320 mikrogram/9 mikrogram
English: If patients find the treatment ineffective, or exceed the highest recommended dose of DuoResp Spiromax, medical attention must be sought (see section 4.2).
Danish: Patienten skal informeres om at søge læge, hvis patienten finder, at behandlingen ikke er effektiv, eller hvis den højeste anbefalede dosis DuoResp Spiromax overskrides (se pkt.
English: DuoResp Spiromax 320 micrograms/9 micrograms inhalation powder
Danish: DuoResp Spiromax 320 mikrogram/9 mikrogram inhalationspulver
English: DuoResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder
Danish: DuoResp Spiromax 160 mikrogram/4,5 mikrogram inhalationspulver
English: DuoResp Spiromax maintenance therapy
Danish: DuoResp Spiromax vedligeholdelsesbehandling
English: Serious asthma-related adverse reactions and exacerbations may occur during treatment with DuoResp Spiromax.
Danish: Under behandling med DuoResp Spiromax kan der forekomme alvorlige astmarelaterede reaktioner og eksacerbationer.
English: Breast-feeding
Danish: DuoResp
English: If either of these symptoms occur, stop using DuoResp Spiromax straightaway and use your ‘reliever inhaler' if you have one.
Danish: skal du straks holde op med at bruge DuoResp Spiromax og bruge din inhalator med anfaldsmedicin, hvis du har en.
English: Tell your doctor if you have any of the following while taking DuoResp Spiromax they could be symptoms of a lung infection:
Danish: Kontakt lægen, hvis du oplever nogle af følgende symptomer, mens du tager DuoResp Spiromax.
English: How to use DuoResp Spiromax
Danish: Sådan skal du bruge DuoResp Spiromax
English: Patients should also be advised to rinse their mouth with water after inhaling (see section 4.4) The patient may notice a taste when using DuoResp Spiromax due to the lactose excipient.
Danish: Patienterne bør informeres om at skylle munden med vand efter inhalation (se pkt.
English: Package leaflet: Information for the patient DuoResp Spiromax 320 micrograms/9 micrograms, inhalation powder budesonide/formoterol fumarate dihydrate
Danish: Indlægsseddel: Information til patienten DuoResp Spiromax 320 mikrogram/9 mikrogram inhalationspulver budesonid/formoterolfumaratdihydrat
English: DuoResp Spiromax maintenance and reliever therapy
Danish: DuoResp Spiromax vedligeholdelses- og behovsbehandling
English: Package leaflet: Information for the patient DuoResp Spiromax 160 micrograms/4.5 micrograms, inhalation powder budesonide/formoterol fumarate dihydrate
Danish: Indlægsseddel: Information til patienten DuoResp Spiromax 160 mikrogram/4,5 mikrogram inhalationspulver budesonid/formoterolfumaratdihydrat
English: Do not use DuoResp Spiromax 320/9 micrograms as a ‘reliever inhaler'.
Danish: Brug ikke DuoResp Spiromax 320 mikrogram/9 mikrogram som anfaldsmedicin
English: DuoResp Spiromax as your only asthma inhaler.
Danish: (B) Brug af DuoResp Spiromax som din eneste astma-inhalator.
English: DuoResp Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate
Danish: DuoResp Spiromax 320 mikrogram/9 mikrogram inhalationspulver budesonid/formoterolfumaratdihydrat
English: DuoResp Spiromax 160 micrograms /4.5 micrograms inhalation powder budesonide / formoterol fumarate dihydrate
Danish: DuoResp Spiromax 160 mikrogram/4,5 mikrogram inhalationspulver budesonid/formoterolfumaratdihydrat
English: DuoResp Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use.
Danish: DuoResp Spiromax 320 mikrogram/9 mikrogram inhalationspulver budesonid/formoterolfumaratdihydrat Til inhalation.
English: DuoResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder budesonide/ formoterol fumarate dihydrate Inhalation use.
Danish: DuoResp Spiromax 160 mikrogram/4,5 mikrogram inhalationspulver budesonid/formoterolfumaratdihydrat Til inhalation.
English: UAB “Sicor Biotech” Tel: +370 5 266 02 03
Danish: Tel: +370 5 266 02 03
English: How to store DuoResp Spiromax
Danish: DuoResp Spiromax.
English: 1 or 2 inhalations (actuations), twice a day, taken in the morning and in the evening Your doctor may increase this to 4 inhalations, twice a day.
Danish: 1 eller 2 inhalationer 2 gange dagligt, som tages om morgenen og om aftenen.
English: What you need to know before you use DuoResp Spiromax 3.
Danish: Det skal du vide, før du begynder at bruge DuoResp Spiromax Sådan skal du bruge DuoResp Spiromax Bivirkninger
English: 1 inhalation (actuation), twice a day, taken in the morning and in the evening Your doctor may increase this to 2 inhalations, twice a day.
Danish: 1 inhalation 2 gange dagligt, som tages om morgenen og om aftenen.
English: How to use DuoResp Spiromax 4.
Danish: 3 Sådan skal du bruge DuoResp Spiromax
English: This will change as your child grows.
Danish: Den vil ændre sig i takt med, at dit barn vokser.
English: Use in all patients
Danish: Brug til alle patienter
English: Your doctor will tell you:
Danish: Din læge vil tale med dig om:
English: • A glass or cup
Danish: • Et glas eller en kop
English: Oral use, after dissolution.
Danish: Oral anvendelse, efter opløsning.
English: There are also links to other websites about rare diseases and treatments.
Danish: Der er også links til andre websteder om sjældne sygdomme, og om hvordan de behandles.
English: Their frequency is not known (frequency cannot be estimated from the available data).
Danish: Hyppigheden af disse kendes ikke (hyppigheden kan ikke estimeres ud fra forhåndenværende data).
English: Absolute bioavailability or bioavailability for humans after oral administration is not known.
Danish: Den absolutte biotilgængelighed eller den humane biotilgængelighed efter oral administration er ukendt.
English: *Reflects volume for total daily dose.
Danish: *Afspejler mængden for samlet daglig dosis.
English: Treatment of overdose should be directed to symptoms.
Danish: Behandling af overdosering bør rettes mod symptomerne.
English: • Throw away any remaining solution.
Danish: • Bortskaf den resterende opløsning.
English: Your child should drink the solution with a meal.
Danish: Dit barn skal drikke opløsningen sammen med et måltid.
English: Do not change your diet without contacting your doctor.
Danish: Du må ikke ændre din diæt uden at have talt med din læge.
English: The table below is an example of how an appropriate dose is calculated
Danish: Tabellen nedenfor viser eksempler på, hvordan passende doser kan udregnes
English: If these are not strictly controlled before or when you become pregnant, this could be harmful to you and to your baby.
Danish: Hvis det ikke er nøje under kontrol før og når du bliver gravid, kan det være skadeligt for dig og dit barn.
English: Date of the first authorisation: 02 December 2008 Date of latest renewal: 02 December 2013
Danish: Dato for første markedsføringstilladelse: 2. december 2008 Dato for seneste fornyelse: 2. december 2013
English: If you notice these signs, contact your doctor immediately.
Danish: Hvis du bemærker disse symptomer, skal du straks kontakte lægen.
English: Gastritis, oesophagitis
Danish: Gastritis, øsofagitis
English: The solution may then be transferred to another cup for administration of the medicinal product.
Danish: Opløsningen kan herefter overføres til et andet bæger med henblik på administration af lægemidlet.
English: Paediatric population The posology is the same in adults, children and adolescents.
Danish: Pædiatrisk population Doseringen er den samme for voksne, børn og unge.
English: If only a portion of this solution needs to be administered, an oral syringe should be used to withdraw the volume of solution to be administered.
Danish: Hvis kun en del af denne opløsning skal administreres, skal der anvendes en oral sprøjte til at trække det volumen opløsning op, der skal administreres.
English: Few cases of allergic reactions (such as skin rash and serious reactions) have been reported.
Danish: Få tilfælde af overfølsomhedsreaktioner (som f.eks. hududslæt og alvorlige reaktioner) er rapporteret.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger hvad angår graviditet, embryonal/føtal udvikling, fødsel eller postnatal udvikling.
English: Each carton contains 30 sachets.
Danish: Hver karton indeholder 30 breve.
English: Important information about some of the ingredients of Kuvan
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Kuvan
English: • If your baby is too small to drink from a glass or a cup you may administer the solution via the oral syringe.
Danish: • Hvis dit barn er for lille til at drikke fra et glas eller en kop, kan du give opløsningen ved hjælp af den orale sprøjte.
English: Very common side effects (may affect more than 1 in 10 people) Headache and runny nose.
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) Hovedpine og løbenæse.
English: Safety and efficacy of Kuvan in patients above 65 years of age have not been established.
Danish: Kuvans sikkerhed og virkning hos patienter over 65 år er ikke klarlagt.
English: Patients who fail to achieve this level of response within the described one month test period should be considered non-responsive, these patients should not be treated with Kuvan and administration of Kuvan should be discontinued.
Danish: Patienter, som ikke opnår et sådan respons inden for testperioden på 1 måned, bør betragtes som nonresponders, disse patienter bør ikke behandles med Kuvan, og Kuvan bør seponeres.
English: It is not known whether sapropterin or its metabolites are excreted in human breast milk.
Danish: Det er ukendt, om sapropterin eller dets metabolitter udskilles i human mælk.
English: Diarrhoea, vomiting, abdominal pain, dyspepsia, nausea
Danish: Diarré, emesis, abdominalsmerter, dyspepsi, kvalme
English: Population pharmacokinetic analysis of sapropterin including patients from birth to 49 years of age showed that body weight is the only covariate substantially affecting clearance or volume of distribution.
Danish: En populationsfarmakokinetisk analyse af sapropterin, der omfattede patienter fra fødsel til 49 år, viste, at kropsvægten er den eneste kovariat, der i væsentlig grad påvirker clearance og fordelingsvolumen.
English: There are limited amount of data from the use of Kuvan in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af Kuvan til gravide kvinder.
English: The solution should be drank within 15 to 20 minutes.
Danish: Opløsningen bør drikkes inden for 15 til 20 minutter.
English: Hypersensitivity reactions (including serious allergic reactions) and rash Metabolism and nutrition disorders
Danish: Overfølsomhedsreaktioner (herunder alvorlige allergiske reaktioner) og udslæt Metabolisme og ernæring
English: 1 bottle per carton.
Danish: 1 tabletbeholder pr. æske.
English: This leaflet was last revised in month/YYYY Other sources of information
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ} Andre informationskilder
English: Determination of response
Danish: Bestemmelse af respons
English: The dose is based on body weight.
Danish: Dosis afhænger af legemsvægten.
English: It may take a few minutes for the tablets to dissolve.
Danish: Det kan tage et par minutter, før tabletterne er opløst.
English: Frequency, type and severity of adverse reactions in children were essentially similar to those in adults.
Danish: Hyppigheden, typen og sværhedsgraden af bivirkninger hos børn svarer stort set til bivirkningerne hos voksne.
English: Small particles may be visible in the solution, but they will not affect the effectiveness of the medicine.
Danish: Der vil kunne ses små partikler i opløsningen, men disse vil ikke påvirke lægemidlets effekt.
English: Dosing for PKU
Danish: Dosering ved PKU
English: Although concomitant administration of inhibitors of dihydrofolate reductase (e.g. methotrexate, trimethoprim) has not been studied, such medicinal products may interfere with BH4 metabolism.
Danish: Til trods for at samtidig administration af dihydrofolatreduktaseinhibitorer (f.eks. methotrexat, trimethoprim) ikke er undersøgt, er det muligt, at sådanne lægemidler kan interferere med metabolismen af BH4.
English: The dietary phenylalanine intake should be maintained at a constant level during this period.
Danish: Fenylalanin indtaget via kosten bør holdes på et konstant niveau i denne periode.
English: Sapropterin dihydrochloride is primarily metabolised in the liver to dihydrobiopterin and biopterin.
Danish: Sapropterindihydrochlorid metaboliseres hovedsageligt i leveren til dihydrobiopterin og biopterin.
English: To be dissolved before use.
Danish: Skal opløses inden brug.
English: • A medicine cup with graduation markings at 20, 40, 60 and 80 ml
Danish: • Et medicinbæger med målemarkeringer ved 20, 40, 60 og 80 ml
English: The following definitions apply to the frequency terminology used hereafter: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from available data).
Danish: De følgende definitioner gælder for den terminologi over hyppighed, der anvendes herefter: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
English: In vitro, sapropterin did not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4/5, nor induce CYP1A2, 2B6, or 3A4/5.
Danish: In vitro hæmmer sapropterin ikke CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 eller CYP3A4/5 og inducerer ikke CYP1A2, CYP2B6 eller CYP3A4/5.
English: Each bottle contains 30, 120 or 240 tablets.
Danish: Hver tabletbeholder indeholder 30, 120 eller 240 tabletter.
English: BH4 is a cofactor for nitric oxide synthetase.
Danish: BH4 er en cofaktor for nitrogenoxidsyntase.
English: The Phase III clinical development program for Kuvan included 2, randomised placebo-controlled studies in patients with PKU.
Danish: Fase III i det kliniske udviklingsprogram for Kuvan omfattede 2 randomiserede, placebokontrollerede forsøg med PKU-patienter.
English: The absorption of sapropterin is higher after a high-fat, high-calorie meal as compared to fasting, resulting, in average, in 40-85% higher maximum blood concentrations achieved 4 to 5 hours after administration.
Danish: Absorptionen af sapropterin er større efter et fedt- og kalorierigt måltid sammenlignet med faste, hvilket gennemsnitligt resulterer i 40-85% større maksimale blodkoncentrationer, opnået 4 til 5 timer efter indgift.
English: Be sure that you know what dose of Kuvan powder your doctor prescribed.
Danish: Du skal være helt sikker på, hvor meget Kuvan pulver din læge har ordineret.
English: If you stop taking Kuvan
Danish: Hvis du holder op med at tage Kuvan
English: Based on the in vitro and in vivo results, co-administration of Kuvan is unlikely to increase systemic exposure to drugs that are substrates for BCRP.
Danish: På baggrund af in vitro- og in vivo-resultaterne er det usandsynligt, at samtidig administration af Kuvan vil øge systemisk eksponering for lægemidler, der er substrater for BCRP.
English: Emesis has been observed in both the safety pharmacology and the repeated-dose toxicity studies.
Danish: Emesis er set såvel i sikkerhedsfarmakologiske studier som i toksicitetsstudier med gentagne doser.
English: • the amount of solution you will need to give your child for their prescribed dose
Danish: • den mængde opløsning, du skal bruge for at give dit barn den ordinerede dosis
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: I hver hyppighedsgruppering er bivirkningerne listet efter faldende alvorlighed.
English: Volume of dissolution (ml)
Danish: Volumen af opløsningen (ml)
English: Kuvan is not expected to affect the ability to drive and use machines.
Danish: Det forventes ikke, at Kuvan påvirker evnen til at føre motorkøretøj og betjene maskiner.
English: Sapropterin is absorbed after oral administration of the dissolved tablet, and the maximum blood concentration (Cmax) is achieved 3 to 4 hours after dosing in the fasted state.
Danish: Sapropterin absorberes efter oral administration af den opløste tablet, og maksimal blodkoncentration (Cmax) opnås 3 til 4 timer efter dosering under faste.