FrancophonIA/ELRC3.0 huggingface dataset:
English: The effect of a single dose of 30 mg or 60 mg of amifampridine phosphate was used to evaluate the pharmacokinetic-QTc relationship of amifampridine concentration on cardiac repolarization exposure in healthy volunteers.
Danish: Effekten af en enkelt dosis amifampridinphosphat på 30 mg eller 60 mg phosphat blev brugt til at evaluere effekten af lægemiddelkoncentrationens farmakokinetiske QTc på eksponeringen for kardial repolarisering hos raske frivillige.
English: FIRDAPSE is used to treat symptoms of a disease of the nerves and the muscles called Lambert-Eaton myasthenic syndrome or LEMS in adults.
Danish: FIRDAPSE anvendes til behandling af voksne for symptomer på en sygdom, der kaldes Lambert-Eatons syndrom, som påvirker nerver og muskler.
English: Other medicines and FIRDAPSE Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med FIRDAPSE Fortæl det altid til lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: • Concomitant use with medicinal products with a known potential to cause QTc prolongation
Danish: • Samtidig brug af lægemidler, der vides at have potentiale for at kunne forårsage
English: There was no effect of amifampridine phosphate on heart rate, atrioventricular conduction or cardiac depolarization as measured by the heart rate, PR and QRS interval durations.
Danish: Amifampradinphosphat havde ikke nogen effekt på hjertefrekvens, atrioventrikulær overledning eller kardial depolarisering målt på hjertefrekvens og varighed af PR- og QRS-interval.
English: The 3-N-acetyl metabolite exposure by AUC0-∞ was up to 6.8-fold higher in slow acetylators and up to 4-fold higher in fast acetylators with severe renal impairment compared to subjects with normal renal function.
Danish: 3-N-acetylmetaboliteksponeringen bestemt ved AUC0-∞ var op til 6,8 gange højere hos langsomme acetylatorer og op til 4 gange højere hos hurtige acetylatorer med svær nedsat nyrefunktion sammenlignet med forsøgspersoner med normal nyrefunktion.
English: LS Mean Diff (95% CI) p-valued
Danish: Gennemsnitlig LS-forskel (95 %
English: No adequate clinical data on exposed pregnancies are available for amifampridine.
Danish: Der foreligger ikke tilstrækkelige kliniske data vedrørende anvendelse af amifampridin til gravide kvinder.
English: Medicinal products with cholinergic effects
Danish: Lægemidler med kolinerge virkninger
English: Exposure of amifampridine was generally higher in subjects with renal impairment than in subjects with normal renal function; however, NAT2 phenotype had a greater effect on an individual's exposure to amifampridine than renal function status (See Table 4).
Danish: Eksponering for amifampridin var generelt højere hos forsøgspersoner med nedsat nyrefunktion end hos forsøgspersoner med en normal nyrefunktion, men NAT2-fænotype havde en større virkning på et menneskes eksponering for amifampridin end nyrefunktionsstatus (se Tabel 4).
English: If any side effects occur, please consult your doctor as you may need to stop increasing the dose.
Danish: Henvend dig straks til lægen, hvis der opstår bivirkninger, da du måske skal stoppe med at øge dosis.
English: These substances include most anti-depressants (tricyclic antidepressants, selective serotonin uptake inhibitors), neuroleptics (phenothiazines and butyrophenones), mefloquine, bupropion and tramadol (see sections 4.4 and 5.1).
Danish: Disse lægemidler omfatter de fleste antidepressiva (tricykliske antidepressiver, selektive serotoninoptagelseshæmmere), neuroleptika (phenothiaziner og butyrophenoner), mefloquin, bupropion og tramadol (se pkt.
English: Medicinal products with atropinic effects
Danish: Lægemidler med atropinlignende virkning
English: FIRDAPSE should be used with caution in patients with liver or kidney problems.
Danish: FIRDAPSE skal anvendes med forsigtighed til patienter med nyre- eller leverproblemer.
English: Concomitant use of medicinal products with a narrow therapeutic window is contraindicated (see section 4.3).
Danish: Samtidig brug af lægemidler med et snævert terapeutisk indeks er kontraindiceret (se pkt.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Perforated unit dose thermoformed blisters
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Perforerede, termoformede dosisblisterpakninger
English: QMG Scoresa
Danish: QMG-scorera
English: • Concomitant use with medicinal products with a narrow therapeutic window (see section 4.5)
Danish: • Samtidig brug af lægemidler med et snævert terapeutisk indeks (se pkt.
English: NAME OF THE MEDICINAL PRODUCT FIRDAPSE 10 mg tablets amifampridine
Danish: LÆGEMIDLETS NAVN FIRDAPSE 10 mg tabletter amifampridin
English: Potent cytochrome P450 (CYP450) enzyme inhibitors e.g. cimetidine, ketoconazole are not likely to inhibit the metabolism of amifampridine by human N-acetyl-transferase enzymes (NATs) giving rise to increased amifampridine exposure.
Danish: Potente CYP-enzyminhibitorer som f.eks. cimetidin og ketoconazol vil sandsynligvis ikke hæmme metaboliseringen af amifampridin via humane N-acetyltransferase-enzymer (NAT'er) og dermed forårsage en øget eksponering for amifampridin.
English: • Anxiety, sleep disorders, drowsiness
Danish: • Angst, søvnforstyrrelser, døsighed
English: BioMarin International Limited Shanbally, Ringaskiddy, Co. Cork, P43 R298 Ireland
Danish: BioMarin International Limited Shanbally, Ringaskiddy, Co. Cork, P43 R298 Irland
English: (hr) mean(S.D.), range t1/2
Danish: (timer) gennemsnit (SD), interval t1/2
English: • Medicines to relax your muscles - (e.g. mivacurium, pipercurium, suxamethonium)
Danish: • Muskelafslappende lægemidler (f.eks. mivacurium, pipercurium, suxamethonium)
English: Amifampridine exposure by AUC0-∞ was up to 2-fold higher in slow acetylators and up to 3-fold higher in fast acetylators with severe renal impairment compared to subjects with normal renal function.
Danish: Amifampridineksponering bestemt ved AUC0-∞ var op til dobbelt så høj hos langsomme acetylatorer og op til 3 gange højere hos hurtige acetylatorer med svært nedsat nyrefunktion sammenlignet med forsøgspersoner med normal nyrefunktion.
English: Patients should be titrated more slowly than those without renal or hepatic impairment with doses increased in 5 mg increments every 7 days.
Danish: Disse patienter bør titreres langsommere end patienter uden nedsat nyre- eller leverfunktion, og doserne bør øges med 5 mg hver 7. dag.
English: There are no data on the pharmacokinetics of amifampridine in paediatric patients (see sections 4.2).
Danish: Der foreligger ikke nogen data om amifampridins farmakokinetik hos pædiatriske patienter (se pkt.
English: • Medicines for mental problems (e.g. haloperidol, carbamazapine, chlorpromazine, clozapine)
Danish: • Lægemidler mod mentale problemer (f.eks. haloperidol, carbamazepin, chlorpromazin,
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains amifampridine phosphate equivalent to 10 mg of amifampridine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder amifampridinphosphat svarende til 10 mg amifampridin.
English: Frequencies were estimated based on a clinical study to evaluate the effects of amifampridine on cardiac repolarization at a single dose of 30 mg or 60 mg in healthy volunteers.
Danish: Hyppigheder blev estimeret baseret på et klinisk forsøg med det formål at evaluere virkningerne af amifampridin på kardial repolarisering ved en enkelt dosis på 30 mg eller 60 mg hos raske frivillige.
English: • Antidepressants - tricyclic antidepressants (e.g. clomipramine, amoxapine), selective serotonin reuptake inhibitors (e.g. citalopram, dapoxetine) and atypical antidepressants (e.g. buproprion)
Danish: • Antidepressiv medicin - tricykliske antidepressiver (f.eks. clomipramin, amoxapin), selektive serotonin-genoptagelseshæmmere (f.eks. citalopram, dapoxetin) og atypiske antidepressiva
English: Table 2: PK Parameters for Amifampridine in Fed and Fasted Subjects Following Administration of a Single Oral Dose of Amifampridine Phosphate
Danish: Tabel 2: Farmakokinetiske parametre for amifampridin hos forsøgspersoner efter fødeindtagelse og ved faste efter administration af en enkelt oral dosis amifampridinphosphat
English: This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
Danish: Det betyder, at det ikke har været muligt at opnå fuldstændig dokumentation for dette lægemiddel, fordi det anvendes til en sjælden sygdom.
English: Non depolarising muscle relaxant acting medicinal products The concomitant use of amifampridine and medicinal products with non-depolarising muscle relaxant effects (e.g. mivacurium, pipercurium) may lead to a decreased effect of both products and should be taken into consideration.
Danish: Ikke depolariserende muskelafslappende lægemidler Samtidig brug af amifampridin og lægemidler med ikke-depolariserende muskelafslappende virkninger (f.eks. mivacurium, pipercurium) kan forårsage en lavere effekt af begge lægemidler og bør tages i betragtning.
English: Marketing Authorisation Holder BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298
Danish: Indehaver af markedsføringstilladelsen BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298
English: Table 3: Mean PK Parameters of Amifampridine in Healthy Subjects after Single Oral Doses (5-30mg) in Slow and Fast Acetylator Phenotypes
Danish: Tabel 3: Gennemsnitlige PK-parametre for amifampridin hos raske forsøgspersoner efter en enkelt oral dosis (5-30 mg) hos langsomme og hurtige acetylator-fænotyper
English: The concomitant use of amifampridine and medicinal products with cholinergic effects (e.g. direct or indirect cholinesterase inhibitors) may lead to an increased effect of both products and should be taken into consideration.
Danish: Samtidig brug af amifampridin og lægemidler med kolinerge virkninger (f.eks. direkte eller indirekte kolinesteraseinhibitorer) kan forårsage en øget virkning af begge lægemidler.
English: Your doctor may increase this dose slowly first to 5 mg (half a tablet) four times daily (i.e. 20 mg per day).
Danish: Lægen kan øge denne dosis langsomt, først til 5 mg (en halv tablet) fire gange dagligt (dvs. 20 mg/dag), og derefter kan lægen fortsætte med at øge den daglige dosis med 5 mg (en halv tablet) om dagen hver 4. eller hver 5. dag.
English: 1 Adverse reactions reported in a clinical study to evaluate the effects of amifampridine on cardiac repolarization at a single dose of 30 mg or 60 mg in healthy volunteers.
Danish: 1 Bivirkninger rapporteret i et klinisk forsøg med det formål at evaluere virkningerne af amifampridin på kardial repolarisering ved en enkelt dosis på 30 mg eller 60 mg hos raske frivillige.
English: Substances which are potent inducers of enzymes that metabolise medicinal products (see section 5.2) The results from in vitro studies suggest there is low potential for drug-drug interactions due to enzyme induction of CYP1A2, CYP2B6, and CYP3A4 enzymes by amifampridine.
Danish: Resultaterne af in vitro-studier tyder på, at der lavt potentiale for lægemiddelinteraktioner som følge af amifamdiprins enzyminduktion af CYP1A2, CYP2B6 og CYP3A4.
English: Each tablet contains amifampridine phosphate equivalent to 10 mg of amifampridine.
Danish: Hver tablet indeholder amifampridinphosphat svarende til 10 mg amifampridin.
English: * Eating a standardised high-fat meal
Danish: Efter fødeindtagelse* (N=46) * Ved indtagelse af et standardiseret måltid med meget fedt
English: A starting dose of 5 mg (half tablet) FIRDAPSE daily is recommended in patients with moderate or severe liver or kidney problems.
Danish: Der anbefales en startdosis på 5 mg (en halv tablet) FIRDAPSE dagligt til patienter med moderate eller alvorlige nyre- eller leverproblemer.
English: What FIRDAPSE looks like and contents of the pack White, round tablet, flat-faced on one side and scored on the other side.
Danish: Hvid, rund tablet medén flad side og delekærv på den anden side.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 December 2009
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: If you have any doubts, ask your doctor or pharmacist for advice.
Danish: Er du i tvivl, så spørg lægen eller på apoteket.
English: Fed* (N=46)
Danish: Fastende (N=45)
English: Table 4: Mean PK Parameters of Amifampridine in Normal and Renal Impaired Subjects after Single Oral Dose Administration (10mg) in Slow and Fast Acetylator Phenotypes
Danish: Tabel 4: Gennemsnitlige farmakokinetiske parametre for amifampridin hos forsøgspersoner med normal og nedsat nyrefunktion efter administration af en enkelt oral dosis (10 mg) hos langsomme og hurtige acetylator-fænotyper
English: • Fits (convulsions)
Danish: • Anfald (kramper)
English: This leaflet was last revised in MM/YYYY
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}
English: • Concomitant use with sultopride (see sections 4.5 and 5.1)
Danish: • Samtidig brug af sultoprid (se pkt.
English: Dizziness1, hypoaesthesia1, paraesthesia1
Danish: Svimmelhed, hypæstesi1, paræstesi1
English: How to take FIRDAPSE
Danish: Sådan skal du tage FIRDAPSE
English: • Medicines that may change the electrical activity of your heart (QT-interval prolongation detectable in the electrocardiogram) e.g., sultopride, disopyramide, cisapride, domperidone,
Danish: • Lægemidler, der kan ændre dit hjertes elektriske aktivitet (Forlænget QT-interval - påvises ved elektrokardiogram) f.eks. sultoprid, disopyramid, cisaprid, domperidon, rifampicin, og ketoconazol (se “ Tag ikke FIRDAPSE”)
English: This dose suits you only.
Danish: Denne dosis er tilpasset specielt til dig.
English: A starting dose of 5 mg amifampridine (half tablet) once per day is recommended in patients with moderate or severe impairment of renal or hepatic function.
Danish: Der anbefales en startdosis på 5 mg amifampridin (en halv tablet) en gang daglig til patienter med moderat eller stærkt nedsat nyre- eller leverfunktion.
English: There was significantly higher exposure to amifampridine in slow acetylators compared to fast acetylators.
Danish: Langsomme acetylatorer havde en signifikant højere eksponering for amifampridin end hurtige acetylatorer.
English: • Sedatives (e.g. barbiturates)
Danish: • Beroligende midler (f.eks. barbiturater)
English: FIRDAPSE should be used with caution in patients with renal or hepatic impairment.
Danish: FIRDAPSE bør anvendes med forsigtighed hos patienter med nedsat nyre- eller leverfunktion.
English: AUC0-∞ (ng·hr/ml)
Danish: AUC0-∞ (ng·t/ml)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains amifampridine phosphate equivalent to 10 mg of amifampridine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder amifampridinphosphat svarende til 10 mg amifampridin.
English: If any adverse reaction occurs, upward dose titration should be discontinued (see sections 4.4 and 5.2).
Danish: Såfremt der opstår bivirkninger, bør dosistitreringen i opadgående retning afbrydes (se pkt.
English: AUC 0 -∞ (ng·h/ml)
Danish: AUC 0 -∞ (ng·time/ml)
English: AUC 0-∞ (ng·h/ml)
Danish: AUC 0-∞ (ng·time/ml)
English: Seizures
Danish: Mavesmerter
English: You should check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apoteket til råds, hvis du er tvivl.
English: Medicinal products with atropinic effects include tricyclic anti-depressants, most H1 atropinic anti-histamines, anticholinergic,
Danish: Lægemidler med atropinlignende virkning omfatter tricykliske antidepressiver, de fleste H1-atropinlignende antihistaminer, antikolinerge lægemidler, lægemidler mod parkinsonisme, atropinlignende antispasmodika, disopyramid, neuroleptika indeholdende phenothiaziner og clozapin.
English: Cardiac disorders Cardiac rhythm disorders, palpitations
Danish: Hjerterytmeforstyrrelser, palpitationer
English: Psychiatric disorders Sleep disorders, anxiety
Danish: Søvnforstyrrelser, angst
English: MAO-B inhibitors (e.g. selegiline, deprenyl), COMT inhibitors (e.g. entacapone)
Danish: trihexylphenidyl, mesylat), MAO-B-hæmmere (f.eks. selegilin, deprenyl), COMT-hæmmere
English: (ng/ml) mean (S.D.), range
Danish: (ng/ml) gennemsnit (SD), interval
English: (ng/ml) Tmax (hr)
Danish: Cmax (ng/ml) Tmax (t) t1/2 (t)
English: There are no data on the pharmacokinetics of amifampridine in patients with hepatic impairment (see sections 4.2 and 4.4).
Danish: Der foreligger ikke data om farmakokinetikken af amifampridin hos patienter med nedsat leverfunktion (se pkt.
English: AUC0-∞ (ng·hr/ml) Mean (S.D.), range
Danish: AUC0-∞ (ng·t/ml) gennemsnit (SD), interval
English: A double-blind, placebo-controlled, randomized withdrawal Study to evaluate the efficacy and safety of amifampridine phosphate in Patients with LEMS was conduct in adult patients 18 years of age or older (n=26).
Danish: For at evaluere virkningen og sikkerheden af amifampridinphosphat hos patienter med Lambert Eaton Myastent syndrom (LEMS) blev der udført et dobbelblindet, placebokontrolleret, randomiseret seponeringsstudie hos voksne patienter på 18 år og derover (n=26).
English: Depolarising muscle relaxant acting medicinal products The concomitant use of amifampridine and medicinal products with depolarising muscle relaxant effects (e.g. suxamethonium) may lead to a decreased effect of both products and should be taken into consideration.
Danish: Samtidig brug af amifampridin og lægemidler med depolariserende muskelafslappende virkninger (f.eks. suxamethonium) kan forårsage en lavere virkning af begge lægemidler og bør tages i betragtning.
English: Renal Status
Danish: Nedsat leverfunktion
English: • Together with medicines that may change the electrical activity of your heart (QT-interval prolongation - detectable in the electrocardiogram), such as:  Sultropride (a medicine prescribed to treat certain behavioural disorders in adults),  Antiarrhythmic medicine (e.g., disopyramide)  Medicines to treat digestive problems (e.g., cisapride, domperidone)
Danish: • Sammen med lægemidler, der kan ændre dit hjertes elektriske aktivitet (Forlænget QT-interval påvises ved elektrokardiogram), såsom:
English:  Medicines to treat infections - antibiotics (e.g., rifampicin) and antifungals (e.g., ketoconazole)
Danish:  Lægemidler mod hjerterytmeforstyrrelser (f.eks. disopyramid)  Lægemidler til behandling af fordøjelsesproblemer (f.eks. cisaprid, domperidon)  Lægemidler til behandling af infektioner - antibiotika (f.eks. rifampicin) og lægemidler til behandling af svampeinfektioner (f.eks. ketoconazol)
English: Upward dose titration should be discontinued if any adverse reaction or ECG abnormality is observed.
Danish: Såfremt der opstår bivirkninger eller observeres ekg-anormaliteter, bør dosistitreringen i opadgående retning afbrydes.
English: Upward dose titration should be discontinued if any adverse reaction occurs (see section 4.2).
Danish: Såfremt der opstår bivirkninger, bør dosisøgningen a fbrydes (se pkt.
English: Elevated liver enzyme levels (transaminases)
Danish: Lever og galdeveje Forhøjede leverenzymniveauer (aminotransferaser) Ikke kendt Hud og subkutane væv
English: Anhydrous colloidal silica
Danish: Silica, vandfri kolloid
English: Amifampridine has shown no effect on embryo-foetal viability and development in rabbits; however, in rats, an increase in the number of mothers delivering still-born offspring was observed (see section 5.3).
Danish: Hos rotter er der imidlertid observeret en stigning i antallet af mødre, der fik dødfødt afkom (se pkt.
English: Skin and subcutaneous disorders
Danish: Depolariserende muskelafslappende lægemidler
English: Slow Fast
Danish: Gennemføres senest
English: If you experience any of these symptoms, you should contact your doctor or pharmacist immediately.
Danish: Fortæl det straks til lægen eller apoteket, hvis du oplever et eller flere af disse symptomer.
English: Posology
Danish: Nyrestatus
English: For patients with mild liver or kidney problems a starting dose of 10 mg (5 mg twice a day) FIRDAPSE daily is recommended.
Danish: Der anbefales en startdosis på 10 mg (5 mg to gange dagligt) FIRDAPSE dagligt til patienter med milde nyre- eller leverproblemer.
English: Fast
Danish: Hjerte
English: (hr) mean (S.D.), range
Danish: (timer) gennemsnit (SD), interval
English: For patients with mild impairment of renal or hepatic function, a starting dose of 10 mg amifampridine (5 mg twice a day) per day is recommended.
Danish: Der anbefales en startdosis på 10 mg amifampridin (5 mg to gange) daglig til patienter med lettere nedsat nyre- eller leverfunktion.
English: • Medicines to treat Parkinson's disease - anticholinergics (e.g. trihexylphenidyl, mesylate),
Danish: • Lægemidler til behandling af Parkinsons sygdom - antikolinerge midler (f.eks.
English: If you take more FIRDAPSE than you should
Danish: Hvis du har taget for meget FIRDAPSE
English: Please see section 5.2 for further information about bioavailability of amifampridine in the fed and fasted state.
Danish: Yderligere oplysninger om biotilgængeligheden af amifampridin indtaget fastende og efter fødeindtagelse, se pkt.
English: • if they drink alcohol
Danish: • hvis du drikker alkohol
English: Proposed review period: Materials will be reviewed annually.
Danish: Foreslået vurderingsperiode: Materialer vil blive vurderet årligt.
English: Who gets these reactions?
Danish: Hvem får sådanne reaktioner?
English: It is very important that you read and understand the information about this serious reaction.
Danish: Det er meget vigtigt, at du læser og forstår oplysningerne om denne alvorlige reaktion.
English: • if you are seriously overweight (especially if you are a woman)
Danish: • hvis du er svært overvægtig (særligt hvis du er kvinde).
English: Children Under 25 kg:
Danish: Børn under 25 kg:
English: Conclusions supported non-inferiority regardless of analysis method.
Danish: Konklusionerne understøtter non-inferioritet uanset analysemetode.
English: WARNING!
Danish: ADVARSEL!
English: An updated RMP should be submitted:
Danish: Desuden skal der fremsendes en opdateret RMP:
English: What are the symptoms?
Danish: Hvad er symptomerne?
English: To date, there is no established biological mechanism to explain a potential increase in risk.
Danish: Indtil nu er der ingen kendt biologisk mekanisme, som kan forklare en potentielt forøget risiko.
English: See Section 4 for more information.
Danish: Se punkt 4 for yderligere oplysninger.
English: Cases of pancreatitis have been reported
Danish: Tilfælde af pancreatitis er blevet rapporteret
English: No firm conclusion could be drawn due to the limited data derived from this study.
Danish: Ingen holdbar konklusion kunne drages ud fra de begrænsede data fra dette studie.
English: • if their immune systems are very weak
Danish: • hvis dit immunsystem er meget svækket
English: From these results, it can be concluded with 95% confidence that the true difference is no greater than 8.4% in favour of the twice daily regimen.
Danish: Ud fra disse resultater kan det konkluderes med 95 % konfidens, at den sande forskel ikke er større end 8,4 % til fordel for to gange daglig regimet.
English: These reactions have often been transitory.
Danish: Bivirkningerne har ofte været forbigående.
English: • if they have been taking combination therapy for a long time
Danish: • hvis du har fået kombinationsbehandling i lang tid
English: You need to keep taking it every day to stop your illness getting worse.
Danish: Du skal tage medicinen hver dag for at forhindre, at sygdommen forværres.
English: Old infections may flare up
Danish: Gamle infektioner kan blusse op
English: Kivexa can be taken with or without food.
Danish: Kivexa kan tages med eller uden mad.
English: These results indicate that FDC can be taken with or without food.
Danish: Disse resultater indikerer, at FDC kan tages med eller uden mad.
English: Whether such neurological disorders are transient or permanent is currently unknown.
Danish: I hvilken udstrækning sådanne neurologiske forstyrrelser er forbigående eller permanente er p.t. ikke kendt.
English: See sections 4.4 and 4.8.
Danish: 4.4 og 4.8.