natgillin/translations-raw huggingface dataset:
Studie CLDE225C2301 var et fase II, multicenter, ikke-blindet, enarmet studie af effektiviteten og sikkerheden aforal sonidegib hos patienter med Hh-aktiveret recidiveret medulloblastoma. 
Study CLDE225C2301 was a Phase II, multi-centre, open-label, single-arm study of the efficacy and safety of oral sonidegib in patients with Hh-activated relapsed medulloblastoma.
Patienterne skal monitoreres nøje for muskelrelaterede symptomer, hvis Odomzo anvendes i kombination med visse lægemidler, der kan øge den potentielle risiko for at udvikle muskeltoksicitet (fx CYP3A4hæmmere, chloroquin, hydroxychloroquin, fibrinsyrederivativer, penicillamin, zidovudin, niacin og HMGCoA-reduktasehæmmere) (se pkt. 
Patients should be closely monitored for muscle-related symptoms if Odomzo is used in combination with certain medicinal products that may increase the potential risk of developing muscle toxicity (e.g. CYP3A4 inhibitors, chloroquine, hydroxychloroquine, fibric acid derivatives, penicillamine, zidovudine, niacin and HMG-CoA reductase inhibitors) (see section 4.5).
Ingen af de patienter, der tog HMG-CoA-reduktasehæmmere, oplevede forhøjet CK i grad 3/4, i modsætning til 6 patienter (9,0 %), der ikke tog HMG-CoA-reduktasehæmmere. 
No patient taking HMG-CoA reductase inhibitors experienced grade 3/4 CK elevations, as opposed to 6 (9.0%) patients not taking HMG-CoA reductase inhibitors.
En af de patienter, der fik Odomzo 200 mg, oplevede muskelsymptomer og CK-stigninger over 10x ULN og havde behov for intravenøs væske sammenlignet med 6 patienter, der fik Odomzo 800 mg. 
One patient receiving Odomzo 200 mg experienced muscle symptoms and CK elevations above 10x ULN and required intravenous fluids, compared to 6 patients receiving Odomzo 800 mg.
Grad 3/4 stigninger i blod-CK blev indberettet hos 8 % af de patienter, der tog Odomzo 200 mg. 
Grade 3/4 increase in blood CK was reported in 8% of patients taking Odomzo 200 mg.
Hos de fleste patienter bedredes muskelsymptomerne og CK-stigningerne med relevant behandling. 
For most patients, muscle symptoms and CK elevations resolved with appropriate management.
• medicin, som hedder nefazodon mod depression 
• a medicine called nefazodone used to treat depression
• Hvis symptomerne vender tilbage, afbrydes behandlingen indtil bedring til baseline. 
• If symptoms re-occur, interrupt treatment until resolution to baseline.
Derudover er den tilsvarende frekvenskategori for hver bivirkning baseret på følgende konvention (CIOMS III): 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). 
In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000
Partielt respons Stabil sygdom Sygdomsprogression Ukendt Tid til tumorrespons (måneder) Median 95 % CI Responsvarighed Antal hændelser* Antal censureret Median (måneder) 95 % CI 
Partial response Disease stabilisation Disease progression Unknown Time to tumour response (months) Median 95% CI Duration of response No. of events* No. censored Median (months) 95% CI
Hvis du glemmer at tage en dosis af Odomzo, skal du tage den, så snart du kommer i tanke om det. 
If you forget to take Odomzo If you forget to take a dose of Odomzo, take it as soon you realise.
EVENTUELLE ANDRE SÆRLIGE ADVARSLER Risiko for alvorlige fostermisdannelser. 
OTHER SPECIAL WARNING(S), IF NECESSARY Risk of severe birth defects.
Myopati [muskeltræthed og muskelsvækkelse] 
Myopathy [muscular fatigue and muscular weakness]
Kvinder, der tager Odomzo, må ikke være eller blive gravide under behandlingen og i 20 måneder efter endt behandling. 
Women taking Odomzo must not be pregnant or become pregnant during treatment and for 20 months after ending treatment.
De skal anvende to anbefalede præventionsmetoder, herunder en yderst effektiv metode og en barrieremetode, under behandlingen med Odomzo og i 20 måneder efter den sidste dosis. 
They must use two methods of recommended contraception, including one highly effective method and a barrier method, during Odomzo therapy and for 20 months after the final dose.
Tabel 1 Anbefalede dosisjusteringer og håndtering ved symptomatisk forhøjet CK og muskelrelaterede bivirkninger 
Table 1 Recommended dose modifications and management for symptomatic CK elevations and muscle-related adverse events
Farmakokinetiske populationsanalyser viste, at alder (testet interval 20-93 år, middelværdi 61 år), kropsvægt (testet interval 42-181 kg, middelværdi 77 kg), køn eller kreatininclearance (testet interval 27,3-290 ml/min, middelværdi 92,9 ml/min) ikke har nogen klinisk relevant påvirkning af den systemiske eksponering for sonidegib. 
Population pharmacokinetic analyses showed that there are no clinically relevant effects of age (range tested from 20-93 years, mean 61 years), body weight (range tested 42-181 kg, mean 77 kg), gender, or creatinine clearance (range tested 27.3-290 ml/min, mean 92.9 ml/min) on the systemic exposure of sonidegib.
Tabel 1 opsummerer anbefalingerne for dosisafbrydelse og/eller dosisreduktion af Odomzo-behandling ved håndtering af symptomatisk forhøjet CK og muskelrelaterede bivirkninger (såsom myalgi, myopati og/eller spasmer). 
Table 1 summarises recommendations for dose interruption and/or dose reduction of Odomzo therapy in the management of symptomatic CK elevations and muscle-related adverse events (such as myalgia, myopathy, and/or spasm).
Da sonidegib ikke udskilles via nyrerne, forventes ingen ændring af den systemiske eksponering hos patienter med nedsat nyrefunktion. 
Since sonidegib is not renally excreted, no change in systemic exposure is anticipated in patients with renal impairment.
Ved eksponering et godt stykke over den kliniske eksponering var nyren et yderligere målorgan. 
At exposures well above the clinical exposure, an additional target organ was the kidney.
• diarré eller halsbrand 
• diarrhoea or heartburn
Det vides ikke, om der kan være en sammenhæng mellem SCC og behandling med Odomzo. 
It is not known whether SCC can be related to treatment with Odomzo.
Abnorm hårvækst 
Abnormal hair growth
Samtidig administration af sonidegib og stærke CYP3A-inducere nedsætter plasmakoncentrationen af sonidegib. 
Co-administration of sonidegib with strong CYP3A inducers decreases sonidegib plasma concentration.
Når der er opnået bedring, genoptages behandlingen ved samme dosisniveau, og CK måles månedligt derefter. 
Upon resolution, resume treatment at the same dose level and measure CK monthly thereafter.
• et naturlægemiddel, som hedder perikon (kaldes også Hypericum perforatum) mod depression. 
• a herbal medicine called St. John's wort (also known as Hypericum perforatum) used to treat depression.
Grad 1 [Forhøjet CK >ULN - 2,5 x ULN] 
Grade 1 [CK elevation >ULN - 2.5 x ULN]
Den indberettede sonidegib-relaterede toksicitet hos pædiatriske patienter var lig med de indberettede resultaterhos voksne med undtagelse af en reduceret hyppighed af muskeltoksicitet (f.eks. CKstigninger observeret hos 16,7 % af pædiatriske patienter sammenlignet med 50 % af voksne i studie X2104) og observationen af post-natal udviklingsmæssig virkning især med forlænget eksponering (indberettet som tilfælde af epifyseskive i forbindelse med phalanxlidelse, knæ subchondral kondensering af epifyseskiveområdet, physeal distal lårbenslidelse, chondropati og krakeleret tand). 
The sonidegib-related toxicity reported in paediatric patients was similar to the results reported in adults, with the exceptions of a reduced incidence of muscle toxicity (e.g. CK elevations observed in 16.7% of paediatric patients compared with 50% of adults in study X2104) and the observation of post-natal development effect particularly with prolonged exposure (reported as cases of epiphyseal plate of phalanx disorder, knee subchondral condensation of area of growth plate, physeal distal femur disorder, chondropathy, and chipped tooth).
I fase II-hovedforsøget tog 12 (15,2 %) af de patienter, der blev behandlet med Odomzo 200 mg, samtidig HMG-CoA-reduktasehæmmere (9 tog pravastatin, 3 tog non-pravastatin-HMG-CoA-reduktasehæmmere, herunder rosuvastatin og simvastatin). 
In the phase II pivotal trial, 12 (15.2%) patients treated with Odomzo 200 mg took concomitant HMG-CoA reductase inhibitors (9 took pravastatin, 3 took non-pravastatin HMG-CoA reductase inhibitors including rosuvastatin and simvastatin).
Du skal bruge én yderst effektiv metode, som fx: 
You must use one highly effective method, such as:
INFORMATION I BRAILLESKRIFT Odomzo 200 mg 
INFORMATION IN BRAILLE Odomzo 200 mg
De mest almindelige bivirkninger, som forekom hos ≥10 % af de patienter, der blev behandlet med Odomzo 200 mg, var muskelspasmer, alopeci, dysgeusi, træthed, kvalme, muskel-, led- og knoglesmerter, diarré, nedsat vægt, nedsat appetit, myalgi, mavesmerter, hovedpine, smerter, opkastning og pruritus. 
The most common adverse drug reactions occurring in ≥10% of patients treated with Odomzo 200 mg were muscle spasms, alopecia, dysgeusia, fatigue, nausea, musculoskeletal pain, diarrhoea, weight decreased, decreased appetite, myalgia, abdominal pain, headache, pain, vomiting and pruritus.
• At patienten skal informere lægen om en hvilken som helst bivirkning 
• That the patient should tell the healthcare professional about any adverse event
Det vides ikke, om Odomzo bliver udskilt i brystmælk og dermed kan skade barnet. 
It is not known whether Odomzo can pass into your breast milk and cause harm to your baby.
Stærke CYP3A-hæmmere inkluderer, men er ikke begrænset til, ritonavir, saquinavir, telithromycin, ketoconazol, itraconazol, voriconazol, posaconazol og nefazodon. 
Strong CYP3A inhibitors include, but are not limited to, ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole and nefazodone.
Den optimale behandlingsvarighed kan variere for hver enkelt patient. 
Benefit of continued treatment should be regularly assessed, with the optimal duration of therapy varying for each individual patient.
Bivirkningerne for den anbefalede dosis fra fase II-hovedforsøget (tabel 2) er opstillet efter MedDRAsystemorganklasse version 18. 
Adverse drug reactions for the recommended dose from the phase II pivotal clinical study (Table 2) are listed by Medical Dictionary for Regulatory Activities (MedDRA) version 18 system organ class.
• udebleven menstruation 
• absence of menstrual periods
Hvis noget af ovenstående gælder for dig, eller hvis du er i tvivl, skal du tale med lægen eller apotekspersonalet, før du tager Odomzo. 
If any of the above apply to you or you are not sure, talk to your doctor or pharmacist before taking Odomzo.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver hård kapsel indeholder 200 mg sonidegib (som fosfat). 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 200 mg sonidegib (as phosphate).
• Informere patienter om, at de ikke må donere blod under behandling med Odomzo og i mindst 
• Inform patients that they should not donate blood during treatment with Odomzo and for at least
En fertil kvinde defineres i Odomzo-programmet for svangerskabsforebyggelse som en kønsmoden kvinde, der 
A woman of childbearing potential is defined in the Odomzo Pregnancy Prevention Programme as a sexually mature female who
Den mediane varighed af eksponering for sonidegib under studie C2301 var 2,8 måneder (område 0,4 til 33,2 måneder) for voksne patienter og 3,5 måneder (område 1,3 til 5,7 måneder) for pædiatriske patienter. 
The median duration of exposure to sonidegib during Study C2301 was 2.8 months (range 0.4 to 33.2 months) for adult patients and 3.5 months (range 1.3 to 5.7 months) for paediatric patients.
Fortæl det især til lægen eller apotekspersonalet, hvis du tager en eller flere af følgende: 
In particular tell your doctor or pharmacist if you are taking any of the following:
Gastro-øsofageal reflukssygdom 
Gastro-oesophageal reflux disorder
Fortæl det straks til lægen eller apotekspersonalet, hvis du får ondt i musklerne, eller hvis du får uforklarlige muskelkramper eller muskelsvækkelse under behandling med Odomzo. 
Tell your doctor or pharmacist immediately if your muscles hurt or you have unexplained muscle cramps or weakness during treatment with Odomzo.
Figur 1 Bedste ændring fra baseline af mållæsioner hos laBCC-patienter ifølge vurdering ved central vurdering efter FAS 
Figure 1 Best change from baseline in the target lesions of laBCC patients per central review assessment by FAS
Generel toksicitet 
General toxicology
Fortæl det straks til lægen eller apotekspersonalet, hvis du bemærker en eller flere af følgende: 
Tell your doctor or pharmacist straight away if you notice any of the following:
Hvis du er i tvivl, skal du tale med din læge eller apotekspersonalet, inden du tager Odomzo. 
If you are not sure, talk to your doctor or pharmacist before taking Odomzo.
Du skal returnere ubrugte kapsler efter endt behandling. 
You should return unused capsules at the end of your treatment.
• Lægers forpligtelser i relation til at udskrive Odomzo 
• Obligations of the health care professional in relation to the prescribing of Odomzo
• muskelkramper, muskelsmerter, smerter i knogler, ledbånd eller sener 
• muscle cramps, muscle pain, pain in the bones, ligaments and tendons
• Ved ikke-nedsat nyrefunktion, og hvis CK bedres til baseline, skal genoptagelse af behandlingen med 200 mg hver anden dag overvejes. 
• If renal function is not impaired and CK resolves to baseline, consider resuming treatment at 200 mg every other day.
Hvis patienten kaster op under behandlingen, må patienten ikke tage en ny dosis før den næste planlagte dosis. 
If vomiting occurs during the course of the treatment, then no re-dosing of the patient is allowed before the next scheduled dose.
Du må ikke donere sæd under din behandling og i 6 måneder efter, at din behandling er afsluttet. 
You should not donate semen during your treatment and for 6 months after your treatment has finished.
• Han skal fortælle sin læge det, hvis hans kvindelige partner bliver gravid, mens han tager Odomzo eller i de første 6 måneder efter sidste dosis. 
• He will tell his healthcare provider if his female partner becomes pregnant while he is taking Odomzo or during the 6 months after his final dose.
Det vides ikke om sonidegib udskilles i sæd. 
It is unknown whether sonidegib is contained in semen.
Odomzo indeholder lactose (mælkesukker). 
Odomzo contains lactose (milk sugar).
Mens du tager Odomzo, skal du altid bruge kondom (så vidt muligt med sæddræbende creme), når du har samleje med en kvindelig partner; også selvom du er steriliseret. 
While you are taking Odomzo, always use a condom (with spermicide, if available) when you have sex with a female partner, even if you have had a vasectomy.
I fase IIhovedforsøget var muskelspasmer de mest almindelige “muskelrelaterede” bivirkninger og blev indberettet hos færre patienter i gruppen, der fik Odomzo 200 mg (54 %), end i gruppen, der fik Odomzo 800 mg 
In the phase II pivotal study muscle spasms were the most common “muscle-related” adverse events, and were reported in fewer patients in the Odomzo 200 mg group (54%) than in the Odomzo 800 mg group (69%).
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1030/001 10 hårde kapsler 
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1030/001 10 hard capsules
• Kapslen skal synkes hel. 
• Swallow the capsule whole.
Hvis samtidig brug af en stærk CYP3A-hæmmer er nødvendig, skal dosis af sonidegib reduceres til 200 mg hver anden dag. 
If concomitant use of a strong CYP3A inhibitor is required, the sonidegib dose should be reduced to 200 mg every other day.
Et dobbeltblindet, randomiseret fase II-forsøg med Odomzo i to dosisniveauer (200 mg eller 800 mg én gang dagligt) blev udført med 230 patienter med enten lokalt fremskredent basalcellecarcinom (laBCC) (n=194) eller metastatisk basalcellecarcinom (mBCC) (n=36). 
A phase II, randomised double-blind study of two dose levels (200 mg or 800 mg once daily) of Odomzo was conducted in 230 patients with either locally advanced basal cell carcinoma (laBCC) (n=194) or metastatic basal cell carcinoma (mBCC) (n=36).
• Kapslen: gelatine, rød jernoxid (E172), titandioxid (E171). 
• Capsule shell: gelatin, red iron oxide (E172), titanium dioxide (E171).
• medicin, som fx ketoconazol (bortset fra shampoo og creme), itraconazol, posaconazol eller voriconazol mod svampeinfektioner 
• medicines such as ketoconazole (not including shampoos and creams), itraconazole, posaconazole or voriconazole used to treat fungal infections
Hovedparten af de patienter, der havde forhøjet CK af grad 2 eller derover, udviklede muskelsymptomer forud for CK-stigningerne. 
The majority of patients who had grade 2 or higher CK elevations developed muscle symptoms prior to the CK elevations.
Samtidig brug af stærke CYP3Ainducere skal undgås, herunder, men ikke begrænset til, carbamazepin, phenobarbital, phenytoin, rifabutin, rifampicin og perikon (Hypericum perforatum). 
Concomitant use of strong CYP3A inducers should be avoided; this includes, but is not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St John's Wort (Hypericum perforatum).
En farmakokinetisk populationsanalyse fandt ingen signifikant påvirkning af nyrefunktionen (kreatininclearance >27 ml/min) på sonidegibs tilsyneladende clearance (CL/F), hvilket tyder på, at dosisjustering ikke er nødvendig hos patienter med nedsat nyrefunktion. 
A population pharmacokinetic analysis did not find significant influence of renal function (creatinine clearance >27 ml/min) on the apparent clearance (CL/F) of sonidegib suggesting that dose adjustment is not necessary in patients with renal impairment.
For at undgå potentiel føtal eksponering under graviditet, skal mandlige patienter altid anvende kondom (så vidt muligt med sæddræbende creme), selv efter vasektomi, når de har samleje med en kvindelig partner mens han tager Odomzo og i 6 måneder efter sidste dosis. 
To avoid potential foetal exposure during pregnancy, male patients, even those who have had a vasectomy, must always use a condom (with spermicide, if available) when having sex with a female partner while taking Odomzo and for 6 months after the final dose.
Amenorré er desuden blevet observeret i kliniske studier hos fertile kvinder (se pkt. 
Additionally, amenorrhoea has been observed in clinical trials in women of childbearing potential (see section 4.8).
Andre dosisjusteringer 
Other dose modifications
• medicin, som fx methotrexat, mitoxantron, irinotecan eller topotecan mod visse typer af kræft eller mod andre sygdomme som leddegigt (rheumatoid arthritis) og psoriasis 
• medicines such as methotrexate, mitoxantrone, irinotecan, or topotecan used to treat certain types of cancers or other diseases such as severe joint problems (rheumatoid arthritis) and psoriasis
• Kapselindhold: crospovidon, lactosemonohydrat, magnesiumstearat, poloxamer (188), silica, kolloid vandfri (kolloid siliciumdioxid), natriumlaurilsulfat (natriumlaurylsulfat). 
• Capsule contents: crospovidone, lactose monohydrate, magnesium stearate, poloxamer (188), silica, colloidal anhydrous (colloidal silicon dioxide), sodium laurilsulfate (sodium lauryl sulfate).
Dette skyldes, at det ikke vides, om Odomzo bliver udskilt i brystmælk og dermed kan skade barnet (se ”Amning”). 
This is because it is not known whether Odomzo can pass into your breast milk and cause harm to your baby (see section “Breast-feeding”).
Efter en enkelt oral dosis på 800 mg var sonidegibs Cmax henholdsvis 20 %, 21 % og 60 % lavere ved let, moderat og svært nedsat leverfunktion sammenlignet med normal leverfunktion. 
Cmax of sonidegib after a single oral 800 mg dose was 20%, 21% and 60% lower in mild, moderate and severe hepatic impairment, respectively, compared to normal hepatic function.
Kriterier for definition af en fertil kvinde 
Criteria defining a woman of childbearing potential
Odomzo-programmet om svangerskabsforebyggelse skal overholdes. 
You must follow the Odomzo Pregnancy Prevention Programme.
• medicin, som fx telithromycin, rifampicin eller rifabutin mod bakterieinfektioner 
• medicines such as telithromycin, rifampicin or rifabutin used to treat bacterial infections
Odomzo-kapsler indeholder lactosemonohydrat. 
Odomzo capsules contain lactose monohydrate.
De hyppigst indberettede laboratorieabnormaliteter af grad 3/4 med en forekomst på ≥5 % hos patienter, der blev behandlet med Odomzo 200 mg, var forhøjet lipase og forhøjet CK i blodet (tabel 3). 
The most commonly reported grade 3/4 laboratory abnormalities with an incidence of ≥5% occurring in patients treated with Odomzo 200 mg were lipase increase and blood CK increase (Table 3).
Sæddonation 
Semen donation
Fertile kvinder skal konsekvent kunne anvende effektiv prævention. 
Women of childbearing potential must be able to comply with effective contraceptive measures.
På grund af risikoen for embryoføtal død eller svære fødselsdefekter, som sonidegib forårsager, må kvinder, som tager Odomzo ikke være gravide eller blive gravide under behandling og i 20 måneder efter endt behandling (se pkt. 
Due to the risk of embryofoetal death or severe birth defects caused by sonidegib, women taking Odomzo must not be pregnant or become pregnant during treatment and for 20 months after ending treatment (see section 4.4).
Den fulde effekt af dosisafbrydelse eller dosisjustering af sonidegib på flere af bivirkningerne forventes generelt at ske efter nogle uger pga. sonidegibs lange halveringstid (se pkt. 
Due to the long half-life of sonidegib the full effect of a dose interruption or dose adjustment of sonidegib on several adverse events is expected to generally occur after a few weeks (see section 5.2).
Dette bruges Odomzo til 
What Odomzo is used for
Blandt de indberettede bivirkninger (tabel 2) var hyppigheden større hos patienter, der tog Odomzo 800 mg, end hos patienter, der tog Odomzo 200 mg, bortset fra muskel- og knoglesmerter, diarré, mavesmerter, hovedpine og pruritus. 
Among adverse drug reactions reported (Table 2), the frequency was greater in patients taking Odomzo 800 mg than in patients taking Odomzo 200 mg except for musculoskeletal pain, diarrhoea, abdominal pain, headache and pruritus.
Hvis symptomerne varer ved trods dosering hver anden dag, skal seponering af behandlingen overvejes. 
If symptoms persist despite alternate-day dosing, consider discontinuing treatment.
I fase II-hovedforsøget opstod der amenorré hos 2 (14,3 %) ud af 14 fertile kvinder eller fertile kvinder, der var steriliseret ved tubal ligation under behandlingen med Odomzo 200 mg eller 800 mg én gang dagligt. 
In the phase II pivotal study, 2 (14.3%) out of 14 women of either child-bearing potential or of child-bearing age sterilised by tubal ligation developed amenorrhoea while on treatment with Odomzo 200 mg or 800 mg once daily.
En farmakokinetisk populationsanalyse viste, at let eller moderat nedsat nyrefunktion ikke havde en signifikant virkning på sonidegibs tilsyneladende clearance (CL/F), hvilket tyder på, at dosisjustering ikke er nødvendig hos patienter med nedsat nyrefunktion (se pkt. 
A population pharmacokinetic analysis found that mild or moderate renal impairment did not have a significant effect on the apparent clearance (CL/F) of sonidegib, suggesting that dose adjustment is not necessary in patients with renal impairment (see section 5.2).
Sonidegibs farmakokinetik blev undersøgt hos forsøgspersoner med let (Child-Pugh klasse A; n=8), moderat (Child-Pugh klasse B; n=8) eller svært (Child-Pugh klasse C; n=9) nedsat leverfunktion og hos 8 raske forsøgspersoner med normal leverfunktion. 
moderate (Child-Pugh class B; n=8) or severe (Child-Pugh class C; n=9) hepatic impairment and in 8 healthy subjects with normal hepatic function.
Hvis det er mere end seks timer efter, at du skulle have taget din dosis, skal du springe den glemte dosis over og tage den næste dosis som planlagt. 
If more than six hours have passed since the dose was due to be taken, skip the missed dose, then take the next dose at the scheduled time.