FrancophonIA/ELRC3.0 huggingface dataset:
English: • during blood tests your doctor may find higher amounts of triglycerides in your blood,
Danish: • lægen kan konstatere øget mængde triglycerider i dine blodprøver
English: Co-administration of rifampicin (600 mg twice daily for 12 days), a potent CYP3A4 inducer, with a single 4 mg oral dose of brexpiprazole resulted in an approximate 31 % and 73 % decrease in brexpiprazole Cmax and AUC, respectively.
Danish: Samtidig administration af rifampicin (600 mg to gange dagligt i 12 dage), der er en potent CYP3A4induktor, og en enkeltdosis på 4 mg oralt brexpiprazol medførte et fald på ca. 31 % og 73 % i hhv. Cmax og AUC for brexpiprazol.
English: The LS Mean, 95 % CI, and p-values for individual trials were derived from an MMRM (Mixed effect Model Repeat Measurement) analysis as follows: fixed effects of site, treatment, visit, and treatment-by-visit interaction, with baseline and baseline-by-visit interaction as covariates.
Danish: Mindste kvadraters gennemsnit, 95 %-KI og p-værdier for individuelle forsøg blev udledt af en MMRM (Mixed effect Model Repeat Measurement)-analyse som følger: faste effekter for interaktion ift.
English: Patients taking CYP2D6 inhibitors and/or CYP3A4 inhibitors
Danish: Patienter, der tager CYP2D6-hæmmere og/eller CYP3A4-hæmmere
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Reproduktionstoksicitet er set i dyreforsøg (se pkt.
English: EU/1/18/1294/003 (10 film-coated tablets) EU/1/18/1294/004 (28 film-coated tablets)
Danish: EU/1/18/1294/003 (10 filmovertrukne tabletter) EU/1/18/1294/004 (28 filmovertrukne tabletter)
English: Maintenance of efficacy trial
Danish: Forsøg til undersøgelse af vedligeholdelse af effekt
English: Film-coated tablet 10 film-coated tablets 28 film-coated tablets
Danish: 10 filmovertrukne tabletter 28 filmovertrukne tabletter
English: This leaflet was last revised in MM/YYYY.
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ} Andre informationskilder
English: Co-administration of a 2 mg single oral dose of brexpiprazole with quinidine (324 mg/day for 7 days), a potent inhibitor of CYP2D6, increased the AUC of brexpiprazole by 94 % and no change in Cmax.
Danish: Samtidig administration af en enkeltdosis på 2 mg oralt brexpiprazol og quinidin (324 mg dagligt i 7 dage), der er en potent hæmmer af CYP2D6, øgede AUC for brexpiprazol med 94 % uden ændring af Cmax.
English: RXULTI 0.25 mg film-coated tablets RXULTI 0.5 mg film-coated tablets RXULTI 1 mg film-coated tablets RXULTI 2 mg film-coated tablets RXULTI 3 mg film-coated tablets RXULTI 4 mg film-coated tablets
Danish: RXULTI 0,25 mg filmovertrukne tabletter RXULTI 0,5 mg filmovertrukne tabletter RXULTI 1 mg filmovertrukne tabletter RXULTI 2 mg filmovertrukne tabletter RXULTI 3 mg filmovertrukne tabletter RXULTI 4 mg filmovertrukne tabletter
English: • pain in the upper abdomen,
Danish: • smerter i den øvre del af maven
English: Co-administration of ketoconazole (200 mg twice daily for 7 days), a potent inhibitor of CYP3A4, with a 2 mg single oral dose of brexpiprazole increased the AUC of brexpiprazole by 97 % and no change in Cmax.
Danish: Samtidig administration af ketoconazol (200 mg to gange dagligt i 7 dage), der er en potent CYP3A4hæmmer, og en enkeltdosis på 2 mg brexpiprazol øgede AUC for brexpiprazol med 97 % uden ændring af Cmax.
English: The maximum recommended dose in patients with moderate to severe impaired renal function is reduced to 3 mg once daily (see section 5.2).
Danish: Den maksimalt anbefalede dosis hos patienter med moderat til svært nedsat nyrefunktion bør reduceres til 3 mg én gang dagligt (se pkt.
English: Placebo Brexpiprazole (2 mg/day)* 113 96.55 Brexpiprazole (4 mg/day) Placebo Brexpiprazole (2 mg/day to 4 mg/day
Danish: Placebo Brexpiprazol (2 mg/dag)* 113 Brexpiprazol (4 mg/dag) Placebo Brexpiprazol (2 mg/dag til 4 mg/dag) Placebo
English: Known CYP2D6 poor metabolisers taking strong/moderate CYP3A4 inhibitors
Danish: Langsomme CYP2D6-omsættere, der tager potente/moderate CYP3A4-hæmmere
English: Higher frequencies of prolactin increased (1.5 % versus 0.60 %) were observed in females compared to males in short-term trials.
Danish: Forekomsten af forhøjet prolaktin var højere hos kvinder end hos mænd i de kortvarige forsøg (1,5 % versus 0,6 %).
English: Twice daily divided dosing of brexpiprazole is preferable as once daily dosing results in high peak to trough fluctuation (see section 4.5).
Danish: Det anbefales at administrere den daglige dosis brexpiprazol ad to omgange, da indgift én gang dagligt giver store udsving mellem højeste og laveste værdi (se pkt.
English: Summary of the safety profile The most frequently observed adverse drug reactions (ADRs) were akathisia (5.6 %) and weight gain
Danish: De hyppigst observerede bivirkninger er akatisi (5,6 %) og vægtforøgelse (3,9 %).
English: shuffling steps, shaking, little or no facial expression, muscle stiffness, drooling,
Danish: (tandhjulsrigiditet), slæbende skridt, rystelser, ingen eller meget få ansigtsudtryk,
English: • a history of seizures (fits) or epilepsy.
Danish: • tidligere har haft krampeanfald eller epilepsi
English: Dosing modifications to half the recommended doses is required for patients with known CYP2D6 poor metaboliser status.
Danish: Det er nødvendigt at ændre dosis hos langsomme CYP2D6-omsættere til halvdelen af de anbefalede doser.
English: In trials 1, 2 and 3 brexpiprazole was titrated as described in section 4.2 with 1 mg for 4 days, followed by 2 mg on days 5 to 7.
Danish: 4.2 med 1 mg i 4 dage, efterfulgt af 2 mg dag 5 til dag 7.
English: Once daily dosing while CYP3A4 inducers are administered results in high peak to trough fluctuation, hence twice daily divided dosing is preferable.
Danish: Ved samtidig administration af CYP3A4-induktorer giver indgift én gang dagligt store udsving mellem højeste og laveste værdi, hvorfor det anbefales at indgive den daglige dosis ad to omgange.
English: QT prolongation can develop in patients treated with antipsychotics.
Danish: Patienter, der behandles med antipsykotika, kan udvikle QT-forlængelse.
English: Orthostatic hypotension and syncope
Danish: Ortostatisk hypotension og besvimelse
English: Rhabdomyolysis
Danish: Lactosemonohydrat
English: How to take RXULTI
Danish: Sådan skal du tage RXULTI
English: Very common Common Uncommon
Danish: Systemorganklasse Meget almindelig
English: Blood prolactin increased1
Danish: Forhøjet blodprolaktin1
English: Primary efficacy measure: PANSS Mean baseline score (SD)
Danish: Primært effektmål: PANSS
English: If brexpiprazole is administered concomitantly with medicinal products known to cause QT prolongation or electrolyte imbalance, caution should be used.
Danish: Der bør udvises forsigtighed, hvis brexpiprazol administreres samtidigt med lægemidler, der giver QTforlængelse eller elektrolytforstyrrelser.
English: • during blood tests your doctor may find increases in liver enzymes.
Danish: • lægen kan konstatere forhøjede leverenzymer i dine blodprøver.
English: Brexpiprazole should be used with caution in patients with a known history of EPS.
Danish: Brexpiprazol bør bruges med forsigtighed hos patienter, der tidligere har oplevet ekstrapyramidale symptomer.
English: (Ki: 0.1 nM to 0.5 nM).
Danish: 4.8 og 5.1).
English: LS Mean Least-squares mean.
Danish: LS Mean Mindste kvadraters gennemsnit KI
English: • muscle pain,
Danish: • muskelsmerter
English: Seizures have been reported during use of brexpiprazole (see section 4.8).
Danish: Der er rapporteret om krampeanfald under behandling med brexpiprazol (se pkt.
English: Brexpiprazole (2 mg/day)* 180 95.85 Brexpiprazole (4 mg/day)* 178 94.70
Danish: Brexpiprazol (2 mg/dag)* 180 Brexpiprazol (4 mg/dag)* 178 Placebo Brexpiprazol (2 mg/dag) Brexpiprazol (4 mg/dag)* 181 94,99
English: RXULTI 0.25 mg film-coated tablets Each film-coated tablet contains 0.25 mg brexpiprazole.
Danish: RXULTI 0,25 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 0,25 mg brexpiprazol.
English: Each film-coated tablet contains 0.25 mg brexpiprazole.
Danish: Hver filmovertrukket tablet indeholder 0,25 mg brexpiprazol.
English: RXULTI 0.5 mg film-coated tablets Each film-coated tablet contains 0.5 mg brexpiprazole.
Danish: RXULTI 0,5 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 0,5 mg brexpiprazol.
English: RXULTI 1 mg film-coated tablets Each film-coated tablet contains 1 mg brexpiprazole.
Danish: RXULTI 1 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 1 mg brexpiprazol.
English: RXULTI 4 mg film-coated tablets White, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 4 one side.
Danish: RXULTI 4 mg filmovertrukne tabletter Hvid, rund, 6 mm i diameter, let konveks og facetslebet, præget med BRX og 4 på den ene side.
English: Electrocardiogram QT prolonged
Danish: Forlænget QT på ekg
English: RXULTI 4 mg film-coated tablets Each film-coated tablet contains 4 mg brexpiprazole.
Danish: RXULTI 4 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 4 mg brexpiprazol.
English: Weight increase
Danish: Forhøjede leverenzymer
English: For nausea, the incidence in the 2 mg to 4 mg brexpiprazole group was 2.3 % overall in short-term controlled trials, compared to 2.0 % in placebo; for vomiting, these incidences were 1.0 % in the brexpiprazole-treated group compared to 1.2 % in placebo group.
Danish: Hvad angår kvalme, var den samlede incidens på 2,3 % i den gruppe, der fik i 2 mg til 4 mg brexpiprazol i kontrollerede kortvarige forsøg, sammenholdt med 2,0 % i placebo-gruppen.
English: RXULTI 0.25 mg film-coated tablets brexpiprazole
Danish: RXULTI 0,25 mg filmovertrukne tabletter brexpiprazol
English: Each film-coated tablet contains 48.2 mg lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 48,2 mg lactose (som monohydrat).
English: If you miss two or more doses, contact your doctor.
Danish: Kontakt lægen, hvis du har glemt at tage to eller flere doser.
English: Angioedema Urticaria
Danish: • krampeanfald
English: RXULTI 2 mg film-coated tablets Each film-coated tablet contains 2 mg brexpiprazole.
Danish: RXULTI 2 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 2 mg brexpiprazol.
English: Each film-coated tablet contains 1 mg brexpiprazole.
Danish: Hver filmovertrukket tablet indeholder 1 mg brexpiprazol.
English: RXULTI 3 mg film-coated tablets Each film-coated tablet contains 3 mg brexpiprazole.
Danish: RXULTI 3 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 3 mg brexpiprazol.
English: Each film-coated tablet contains 0.5 mg brexpiprazole.
Danish: Hver filmovertrukket tablet indeholder 0,5 mg brexpiprazol.
English: RXULTI 4 mg film-coated tablets brexpiprazole
Danish: RXULTI 4 mg filmovertrukne tabletter brexpiprazol
English: Light orange, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 0.5 on one side.
Danish: Lyseorange, rund, 6 mm i diameter, let konveks og facetslebet, præget med BRX og 0.5 på den ene side.
English: RXULTI 1 mg film-coated tablets
Danish: RXULTI 1 mg filmovertrukne tabletter
English: RXULTI 1 mg film-coated tablets brexpiprazole
Danish: RXULTI 1 mg filmovertrukne tabletter brexpiprazol
English: It should be noted that impulse-control symptoms can be associated with the underlying disorder; however, in some cases, urges were reported to have stopped when the dose was reduced or the medication was discontinued.
Danish: Det bør bemærkes, at symptomer på manglende impulskontrol kan være forbundet med den underliggende sygdom.
English: RXULTI 0.5 mg film-coated tablets brexpiprazole
Danish: RXULTI 0,5 mg filmovertrukne tabletter brexpiprazol
English: RXULTI 0.25 mg film-coated tablets Iron oxide E 172 (yellow, red, black)
Danish: Jernoxid E 172 (gul, rød, sort)
English: RXULTI 0.25 mg film-coated tablets
Danish: RXULTI 0,25 mg filmovertrukne tabletter
English: RXULTI 2 mg film-coated tablets
Danish: RXULTI 2 mg filmovertrukne tabletter
English: Light brown, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 0.25 on one side.
Danish: Lysebrun, rund, 6 mm i diameter, let konveks og facetslebet, præget med BRX og 0.25 på den ene side.
English: • nausea,
Danish: • kvalme
English: Each film-coated tablet contains 2 mg brexpiprazole.
Danish: Hver filmovertrukket tablet indeholder 2 mg brexpiprazol.
English: Each film-coated tablet contains 47.9 mg lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 47,9 mg lactose (som monohydrat).
English: RXULTI 2 mg film-coated tablets brexpiprazole
Danish: RXULTI 2 mg filmovertrukne tabletter brexpiprazol
English: RXULTI 3 mg film-coated tablets
Danish: RXULTI 3 mg filmovertrukne tabletter
English: Each film-coated tablet contains 4 mg brexpiprazole.
Danish: Hver filmovertrukket tablet indeholder 4 mg brexpiprazol.
English: Each film-coated tablet contains 3 mg brexpiprazole.
Danish: Hver filmovertrukket tablet indeholder 3 mg brexpiprazol.
English: RXULTI 3 mg film-coated tablets brexpiprazole
Danish: RXULTI 3 mg filmovertrukne tabletter brexpiprazol
English: RXULTI 0.5 mg film-coated tablets
Danish: RXULTI 0,5 mg filmovertrukne tabletter
English: RXULTI 3 mg film-coated tablets EU/1/18/1294/006 (28 film-coated tablets)
Danish: RXULTI 3 mg filmovertrukne tabletter EU/1/18/1294/006 (28 filmovertrukne tabletter)
English: RXULTI 3 mg film-coated tablets Iron oxide E 172 (red, black)
Danish: Jernoxid E 172 (rød, sort)
English: RXULTI 2 mg film-coated tablets EU/1/18/1294/005 (28 film-coated tablets)
Danish: RXULTI 2 mg filmovertrukne tabletter EU/1/18/1294/005 (28 filmovertrukne tabletter)
English: RXULTI 4 mg film-coated tablets EU/1/18/1294/007 (28 film-coated tablets)
Danish: RXULTI 4 mg filmovertrukne tabletter EU/1/18/1294/007 (28 filmovertrukne tabletter)
English: Strong CYP2D6 inhibitors
Danish: Potente CYP2D6-hæmmere
English: Each film-coated tablet contains 46.4 mg lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 46,4 mg lactose (som monohydrat).
English: RXULTI 0.25 mg film-coated tablets EU/1/18/1294/001 (28 film-coated tablets)
Danish: RXULTI 0,25 mg filmovertrukne tabletter EU/1/18/1294/001 (28 filmovertrukne tabletter)
English: RXULTI 0.5 mg film-coated tablets EU/1/18/1294/002 (28 film-coated tablets)
Danish: RXULTI 0,5 mg filmovertrukne tabletter EU/1/18/1294/002 (28 filmovertrukne tabletter)
English: RXULTI contains lactose
Danish: RXULTI indeholder lactose
English: Each film-coated tablet contains 45.4 mg lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 45,4 mg lactose (som monohydrat).
English: Dysphagia
Danish: Vægtøgning
English: RXULTI 2 mg film-coated tablets Iron oxide E 172 (yellow, black)
Danish: Jernoxid E 172 (gul, sort)
English: Each film-coated tablet contains 47.4 mg lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 47,4 mg lactose (som monohydrat).
English: Each film-coated tablet contains 44.4 mg lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 44,4 mg lactose (som monohydrat).
English: If you take more RXULTI than you should
Danish: Hvis du har taget for meget RXULTI
English: Further dosing modifications to a quarter of the recommended dose is required for known CYP2D6 poor metabolisers while taking strong or moderate CYP3A4 inhibitors (see sections 4.5 and 5.2).
Danish: For langsomme CYP2D6-omsættere, som tager potente eller moderate CYP3A4-hæmmere, er det nødvendigt at ændre dosis yderligere til en fjerdedel af den anbefalede dosis (se pkt.
English: Placebo Brexpiprazole (2 mg/day) Brexpiprazole (4 mg/day)* 181 94.99
Danish: Brexpiprazol (2 mg/dag) Brexpiprazol (4 mg/dag)*
English: CYP2D6 inhibitors
Danish: CYP2D6-hæmmere
English: What RXULTI is and what it is used for What you need to know before you take RXULTI How to take RXULTI
Danish: Det skal du vide, før du begynder at tage RXULTI Sådan skal du tage RXULTI Bivirkninger
English: Breast-feeding
Danish: Dysfagi
English: Prolactin
Danish: Prolaktin
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Danish: (Navn og adresse) <{tlf}> <{fax}> <{email}>
English: 136 50 Haninge Sweden
Danish: 136 50 Haninge Sverige
English: Use in children and adolescents:
Danish: Anvendelse til børn og unge:
English: (Invented) Name Strength
Danish: (Særnavn) Navn Styrke
English: • tell your carer or another person in your house what has happened
Danish: • fortæl Deres plejer eller en anden person i hjemmet, hvad der er sket
English: Tell your doctor if you have taken this type of medicine within the last two weeks
Danish: Fortæl det til lægen, hvis De har taget denne type medicin inden for de sidste to uger
English: Notwithstanding this, the Applicant remains committed to the proposed comprehensive risk management plan that will be put in place.
Danish: På trods af dette har ansøgeren stadig forpligtet sig til den foreslåede omfattende risikohåndteringsplan, som vil blive indført.
English: Teratogenic effects have, however, not been demonstrated.
Danish: Der er imidlertid ikke påvist teratogene virkninger.
English: Tel. +46 8 6025200
Danish: Tlf.: +46 8 6025200
English: Taking Rapinyl with food and drink
Danish: Brug af Rapinyl sammen med mad og drikke
English: The data submitted builds on clinical data from 221 volunteers and 41 patients.
Danish: De fremsendte data bygger på kliniske data fra 221 frivillige og 41 patienter.
English: This product should ONLY be used by you according to your doctor's instructions.
Danish: Dette produkt må KUN bruges i overensstemmelse med lægens instrukser.
English: • Medicines containing alcohol
Danish: • Medicin, der indeholder alkohol
English: If the product is used by anyone else it could represent a SERIOUS risk to their health
Danish: Hvis produktet anvendes af andre kan det udgøre en ALVORLIG risiko for deres helbred.
English: This calculation seems reasonable, however, responder analysis should be provided when available.
Danish: Denne beregning forekommer rimelig, men en responsanalyse skal foreligge, når det er muligt.
English: This is illustrated in the schedule below.
Danish: Dette er illustreret i nedenstående tabel.
English: Doses higher than 800 micrograms have not been evaluated in clinical studies.
Danish: Doser højere end 800 mikrogram har ikke været vurderet i kliniske studier.
English: Recip AB Lagervägen 7
Danish: Lagervägen 7
English: It should not be used by anyone else as it could present a SERIOUS risk to their health, especially in children.
Danish: Det må ikke bruges af andre, da det kan udgøre en ALVORLIG risiko for deres helbred, især hos børn.
English: In such a case, opioids should be used only if absolutely necessary.
Danish: I dette tilfælde skal opioider kun anvendes, hvis det er absolut nødvendigt.
English: Initial Phase - Finding the most appropriate dose
Danish: Indledende fase - at finde den mest passende dosis
English: Symptoms of overdose include:
Danish: Symptomer på overdosering omfatter:
English: The bioavailability of Rapinyl has not been studied but is estimated to be about 70%.
Danish: Biotilgængeligheden af Rapinyl er ikke undersøgt men skønnes at være ca. 70 %.
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares over 25°C.
English: BATCH NUMBER Lot: XXXX
Danish: FREMSTILLERENS BATCHNUMMER Lot: XXXX
English: • remove any remaining tablets from your mouth
Danish: • fjern evt. tilbageværende resoribletter fra munden
English: If you are not sure, talk to your doctor.
Danish: Hvis De ikke er sikker, så tal med lægen.
English: The safety of fentanyl in pregnancy has not been established.
Danish: Sikkerheden af fentanyl under graviditet er ikke blevet undersøgt.
English: A mutagenic risk with therapeutic use seems unlikely since effects were induced only at very high concentrations.
Danish: En mutagen risiko ved terapeutisk brug synes usandsynlig, da virkningerne kun blev induceret ved meget høje koncentrationer.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF RAPINYL AND ASSOCIATED NAMES (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF RAPINYL OG TILKNYTTEDE NAVNE (se bilag I)
English: A patent airway should be established and maintained.
Danish: Frie luftveje skal etableres og vedligeholdes.
English: Conclusion on LoQ
Danish: Konklusion på LoQ
English: • Place the tablet under your tongue as far back as you can and let it dissolve completely.
Danish: • Anbring resoribletten under tungen så langt tilbage De kan og lad den blive helt opløst.
English: Several doses are available for use during the dose titration phase.
Danish: Der er adskillige doser tilgængelige til brug under dosistitreringsfasen.
English: Other known side effects associated with fentanyl products include:
Danish: Andre kendte bivirkninger forbundet med fentanyl-produkter omfatter:
English: • while waiting for the doctor, keep the person awake by talking to or shaking her/him now and then
Danish: • mens der ventes på lægen, skal personen holdes vågen ved at snakke med denne eller ryste hende/ham en gang imellem
English: As the safety of transmucosal fentanyl is well described, any relevant safety issues would have been observed as serious events.
Danish: Da sikkerheden ved transmucosal fentanyl er velbeskrevet, ville eventuelle relevante sikkerhedsproblemer have været registreret som alvorlige hændelser.
English: Use in elderly patients
Danish: Anvendelse til ældre patienter
English: It may harm them, even if their symptoms are the same as yours.
Danish: Det kan være skadeligt for andre, selvom de har samme symptomer, som De har.
English: Long-term carcinogenicity studies have not been performed.
Danish: Der er ikke foretaget langtids-carciogenicitetsundersøgelser.
English: In addition, the sponsor provided a number of independent overwhelmingly positive benefit/risk judgements from experts in palliative care.
Danish: Desuden fremlagde sponsor en række uafhængige og i overvældende grad positive risk/benefitvurderinger fra eksperter inden for palliativ behandling.
English: Maintenance Phase - Once you have found the most appropriate dose
Danish: Vedligeholdelsesfase - efter De har fundet den mest passende dosis
English: Rapid absorption of fentanyl occurs over about 30 minutes following administration of Rapinyl.
Danish: Hurtig absorption af fentanyl sker i løbet af ca. 30 minutter efter administration af Rapinyl.
English: The main use of the referred interim analyses is in the detection of any new safety signals and as a comparison of the efficacy in relation to earlier findings.
Danish: Den væsentligste brug af de omtalte interimanalyser er til påvisning af eventuelle nye sikkerhedssignaler og til sammenligning af effekten i forhold til tidligere resultater.
English: About 80-85% of fentanyl is bound by plasma proteins, mainly α1-glycoprotein and to a lesser extent albumin and lipoprotein.
Danish: Ca. 80-85 % fenatyl bindes af plasmaproteiner, hovedsageligt α1-glycoprotein og i mindre grad albumin og lipoprotein.
English: In conclusion, the CHMP considered that the Applicant had answered the questions adequately.
Danish: Afslutningsvis vurderede CHMP, at ansøgeren havde besvaret spørgsmålene fyldestgørende.
English: An extrapolation of the PID at 10 and 15 minutes to responder rates has been provided by the Applicant.
Danish: En ekstrapolation af PID efter 10 og 15 minutter som responsrater er fremlagt af ansøgeren.
English: • you or your carer should immediately contact your doctor, pharmacist or local hospital and discuss what action to take
Danish: • De eller Deres plejer skal straks kontakte lægen, apoteket eller det lokale hospital og drøfte,
English: • a slow heart rate or low blood pressure
Danish: • langsom hjertefrekvens eller lavt blodtryk
English: Your doctor will help you do this and will work with you to find the best strength of tablet to use.
Danish: Lægen vil hjælpe Dem med at gøre dette og vil sammen med Dem finde den optimale tabletstyrke.