FrancophonIA/ELRC3.0 huggingface dataset:
English: In rats, prucalopride in vivo, at doses above 5 mg/kg (at and above 30-70 times the clinical exposure), induced hyperprolactinaemia caused by an antagonistic action at the D2 receptor.
Danish: Ved doser over 5 mg/kg in vivo hos rotter (svarende til 30-70 gange højere eller mere end den kliniske eksponering) inducerede prucaloprid hyperprolaktinæmi som følge af en antagonistisk handling ved D2-receptoren.
English: The primary endpoint of the study was met: a statistically significantly higher percentage of subjects in the Resolor group (37.9%) had an average of ≥3 SCBMs/week compared with subjects in the placebo treatment group (17.7%) (p<0.0001) over the 12-week double-blind treatment period.
Danish: Studiets primære endepunkt blev opfyldt: En statistisk signifikant højere andel af patienterne i Resolor-gruppen (37,9 %) havde gennemsnitligt ≥ 3 SCBM'er/uge sammenholdt med patienterne i placebo-gruppen (17,7 %) (p < 0,0001) i den dobbeltblindede behandlingsperiode på 12 uger.
English: On once daily treatment with 2 mg prucalopride, steady-state plasma concentrations fluctuate between trough and peak values of 2.5 and 7 ng/ml, respectively.
Danish: Ved behandling én gang dagligt med 2 mg prucaloprid fluktuerede steady state-plasmakoncentrationerne mellem 2,5 ng/ml og 7 ng/ml som henholdsvis laveste og højeste værdi.
English: Palpitations were reported in 0.7% of the placebo patients, 0.9% of the 1 mg prucalopride patients, 0.9% of the 2 mg prucalopride patients and 1.9% of the 4 mg prucalopride patients.
Danish: Palpitationer blev rapporteret hos 0,7 % af de placebo-behandlede patienter, hos 0,9 % af de patienter, der blev behandlet med 1 mg prucaloprid, hos 0,9 % af de patienter, der blev behandlet med 2 mg prucaloprid, og hos 1,9 % af de patienter, der blev behandlet med 4 mg prucaloprid.
English: An extended series of safety pharmacology studies with special emphasis on cardiovascular parameters showed no relevant changes in haemodynamic and ECG derived parameters (QTc) with the exception of a modest increase in heart rate and blood pressure observed in anaesthetised pigs after intravenous administration, and an increase in blood pressure in conscious dogs after bolus intravenous administration, which was not observed either in anaesthetised dogs or after oral administration in dogs reaching similar plasma levels.
Danish: Undtagelsen herfra var en beskeden stigning i hjerterytme og blodtryk observeret hos bedøvede svin efter intravenøs administration og en stigning i blodtryk hos hunde ved bevidsthed efter intravenøs administration af en bolus-dosis, hvilket ikke sås hverken hos bedøvede hunde eller efter oral administration hos hunde, der nåede lignende plasmaniveauer.
English: Patients with hepatic impairment: Patients with severe hepatic impairment (Child-Pugh class C) start with 1 mg once daily which may be increased to 2 mg if required to improve efficacy and if the 1 mg dose is well tolerated (see sections 4.4 and 5.2).
Danish: Patienter med nedsat leverfunktion: Patienter med svært nedsat leverfunktion (Child-Pugh klasse C) skal starte med 1 mg én gang dagligt, som om nødvendigt kan øges til 2 mg for at forbedre virkningen, hvis 1 mg dosis er veltolereret (se pkt.
English: Resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.
Danish: Resolor er indiceret til symptomatisk behandling af kronisk obstipation hos voksne, der ikke opnår tilstrækkelig lindring med laksantia.
English: After once daily dosing of 1 mg, peak plasma concentrations and AUC of prucalopride in older people were 26% to 28% higher than in young adults.
Danish: Efter dosering med 1 mg én gang dagligt var maksimumplasmakoncentrationen af og AUC for prucaloprid 26 % til 28 % højere hos ældre personer end hos unge voksne.
English: No dose adjustment is required for patients with mild to moderate renal impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat nyrefunktion.
English: The following side effects have been reported very commonly (may affect more than 1 in 10 people): headache, feeling sick, diarrhoea and abdominal pain.
Danish: Følgende meget almindelige bivirkninger er blevet indberettet (kan forekomme hos flere end 1 ud af 10 personer): hovedpine, kvalme, diarré og mavesmerter.
English: The efficacy and safety of Resolor in paediatric patients (aged 6 months to 18 years) with functional constipation, were evaluated in an 8-week double-blind, placebo-controlled trial (N=213), followed by a 16 week open-label comparator-controlled (Polyethylene glycol 4000) study of up to 24 weeks (N=197).
Danish: Resolors virkning og sikkerhed hos pædiatriske patienter (i alderen 6 måneder til 18 år) med funktionel obstipation blev undersøgt i et 8 ugers, dobbeltblindt, placebokontrolleret studie (N = 213) efterfulgt af et 16-ugers åbent komparatorkontrolleret (polyethylenglycol 4000) studie på op til 24 uger (N = 197).
English: Furthermore, giant migrating contractions are induced by prucalopride.
Danish: Ydermere inducerer prucaloprid kæmpestore migrerende kontraktioner.
English: Aluminium/aluminium perforated unit dose blisters (calendar marked) containing 7 tablets.
Danish: Aluminium/aluminium perforerede enkeltdosisblistere (kalendermærket) indeholdende 7 tabletter.
English: Metabolism is not the major route of elimination of prucalopride.
Danish: Den væsentligste elimination af prucaloprid sker ikke ved metabolisme.
English: Other medicines and Resolor Tell your doctor if you are taking, or have recently taken, or might take any other medicines.
Danish: Fortæl altid lægen eller på apoteket, hvis du bruger anden medicin eller har gjort det for nylig.
English: The most frequently reported adverse reactions associated with Resolor 2 mg therapy are headache (17.8%) and gastrointestinal symptoms (abdominal pain (13.7%), nausea (13.7%) and diarrhoea (12.0%)).
Danish: De hyppigst rapporterede bivirkninger ved behandling med 2 mg Resolor var hovedpine (17,8 %) og symptomer i mave-tarm-kanalen (abdominale smerter (13,7 %), kvalme (13,7 %) og diarré (12,0 %)).
English: In subjects with severe renal impairment (ClCR ≤24 ml/min), plasma concentrations were 2.3 times the levels in healthy subjects (see section 4.2 and 4.4).
Danish: Hos studiepersoner med svært nedsat nyrefunktion (ClCR ≤ 24 ml/min) var plasmakoncentrationerne 2,3 gange niveauet hos raske studiepersoner (se pkt.
English: Excipients with known effect: Each film-coated tablet contains 156.75 mg lactose (as monohydrate).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hver filmovertrukken tablet indeholder 156,75 mg lactose (som monohydrat).
English: At Week 4, the proportion of patients with an improvement of ≥1 versus baseline in the Patient Assessment of Constipation-Quality of Life satisfaction subscale (PAC-QOL) was 47.7% in patients treated with Resolor 2 mg compared with 20.2% in patients on placebo.
Danish: Ved uge 4 var andelen af patienter med en forbedring på ≥1 vs. baseline i delskalaerne for Patient Assessment of Constipation-Quality of Life-tilfredshed (PACQOL) 47,7 % hos patienter i behandling med 2 mg Resolor, sammenlignet med 20,2 % hos patienter på placebo.
English: Lactose monohydrate Microcrystalline cellulose Colloidal silicon dioxide Magnesium stearate
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose Kolloid silica
English: The following uncommon side effects have also been seen (may affect up to 1 in 100 people): tremors, pounding heart, rectal bleeding, increase in frequency of passing urine (pollakiuria), fever and feeling unwell.
Danish: Følgende ikke almindelige bivirkninger er også set (kan forekomme hos op til 1 ud af 100 personer): rystelser, hjertebanken, blødning fra endetarmen, hyppig vandladning (pollakisuri), feber og utilpashed.
English: Prucalopride o.d. displays time-independent kinetics during prolonged treatment.
Danish: Prucaloprid én gang dagligt har under forlænget behandling udvist tidsuafhængig kinetik.
English: Tablet coating Hypromellose Lactose monohydrate Triacetin
Danish: Tabletovertræk: Hypromellose Lactosemonohydrat Triacetin
English: The 2 mg tablet also contains iron oxide red (E172), iron oxide yellow (E172), indigo carmine aluminium lake (E132).
Danish: 2 mg-tabletten indeholder også rødt jernoxid (E 172), gult jernoxid (E 172) og indigocarmin aluminium lake (E132).
English: In addition, the efficacy, safety and tolerability of Resolor in male patients with chronic constipation were evaluated in a 12-week, multi-centre, randomised, double-blind, placebo-controlled study (N=370).
Danish: Derudover blev Resolors virkning, sikkerhed og tolerabilitet hos mandlige patienter med kronisk obstipation vurderet i et randomiseret, dobbeltblindet, placebokontrolleret 12-ugers multicenterstudie (N = 370).
English: In vitro, only at concentrations exceeding its 5-HT4 receptor affinity by at least 150-fold, affinity for other receptors was detected.
Danish: Der er i in vitro-studier kun fundet affinitet for andre receptorer ved koncentrationer, der var mere end 150 gange højere end dets 5-HT4-receptoraffinitet.
English: Table 1: Adverse Drug Reactions (ADRs) Associated with Resolor
Danish: Tabel 1: Bivirkninger ved Resolor
English: A dose of 1 mg is recommended in subjects with severe renal impairment (see section 4.2).
Danish: En dosis på 1 mg anbefales hos patienter med svært nedsat nyrefunktion (se pkt.
English: The proportion of patients with an average weekly frequency of ≥3 Spontaneous Complete Bowel Movements (SCBMs) per week (i.e., responders) over the 24-week double-blind treatment phase was not statistically different (p=0.367) between the Resolor (25.1%) and placebo (20.7%) treatment groups.
Danish: Andelen af patienter med gennemsnitligt ≥3 spontane, fuldstændige afføringer (SCBM) om ugen (dvs. respondenter) i den 24-ugers dobbeltblindede behandlingsfase var ikke statistisk forskellig (p=0,367) mellem Resolor-gruppen (25,1 %) og placebogruppen (20,7 %).
English: A subcutaneous neonatal/juvenile toxicity study performed in rats 7-55 days of age resulted in a NOAEL of 10 mg/kg/day.
Danish: Et toksicitetsstudie med subkutan administration hos nyfødte/unge rotter med en alder på 7-55 dage medførte et NOAEL (no observed adverse effect level) på 10 mg/kg/dag.
English: A clinically meaningful improvement of ≥1 SCBM per week, the most important secondary efficacy endpoint, was achieved in 51.0% (week 4) and 44.2% (week 12) treated with 2 mg Resolor versus 21.7% (week 4) and 22.6% (week 12) of placebo patients.
Danish: En klinisk relevant forbedring på ≥ 1 SCBM pr. uge, det vigtigste sekundære endepunkt, blev opnået hos 51,0 % (uge 4) og 44,2 % (uge 12) af patienterne behandlet med 2 mg Resolor vs. 21,7 % (uge 4) og 22,6 % (uge 12) af placebopatienterne.
English: Lactose monohydrate Triacetin
Danish: Lactosemonohydrat Triacetin
English: The following side effects have been reported commonly (may affect up to 1 in 10 people): decreased appetite, dizziness, vomiting, disturbed digestion (dyspepsia), windiness, abnormal bowel sounds, tiredness.
Danish: Følgende almindelige bivirkninger er blevet rapporteret (kan forekomme hos op til 1 ud af 10 personer): nedsat appetit, svimmelhed, opkastning, fordøjelsesforstyrrelser (dyspepsi), luft i maven, unormale tarmlyde, træthed.
English: In all three studies, treatment with Resolor also resulted in significant improvements in a validated and disease specific set of symptom measures (PAC-SYM), including abdominal (bloating, discomfort, pain and cramps), stool (incomplete bowel movements, false alarm, straining, too hard, too small) and rectal symptoms (painful bowel movements, burning, bleeding/tearing), determined at week 4 and week 12.
Danish: mavebesvær, smerter og kramper), afføringsrelaterede (ufuldstændige afføringer, falsk alarm, forcering, for hårde, for små) og rektale symptomer (smertefulde afføringer, brændende fornemmelse, blødning/fissurer), vurderet i uge 4 og 12.
English: Iron oxide red (E172) Iron oxide yellow (E172) Indigo carmine aluminium lake (E132)
Danish: Jernoxid, rød (E172) Jernoxid, gul (E172) Indigocarmin aluminium lake (E 132)
English: The efficacy and safety of Resolor in patients (aged ≥18 or older) with chronic constipation, were evaluated in a 24 week multicentre, randomised, double-blind, placebo controlled study (N=361).
Danish: Resolors virkning og sikkerhed hos patienter (i alderen ≥18) med kronisk forstoppelse blev undersøgt i et 24-ugers randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie (N=361).
English: Similar results were observed at Week 12: 46.9% in 2 mg Resolor patients versus 19.0% in placebo patients (p<0.001 vs placebo).
Danish: Tilsvarende resultater blev observeret ved uge 12: 46,9 % hos patienter i behandling med 2 mg Resolor vs. 19,0 % hos patienter på placebo (p<0,001 vs. placebo).
English: Excipients with known effect: Each film-coated tablet contains 142.5 mg lactose (as monohydrate).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hver filmovertrukken tablet indeholder 142,5 mg lactose (som monohydrat).
English: Resolor is provided in aluminium/aluminium perforated unit dose blister (calendar marked) containing 7 tablets.
Danish: Resolor fås i aluminium/aluminium perforerede enkeltdosisblisterkort (mærket med ugedagene) indeholdende 7 tabletter.
English: Method of administration Oral use
Danish: Administration Oral anvendelse.
English: If you take more Resolor than you should
Danish: Hvis du har taget for mange Resolor
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Tabletterne indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: The active substance is prucalopride.
Danish: Aktivt stof: prucaloprid.
English: Pink, round, biconvex tablets marked “PRU 2” on one side.
Danish: Lyserøde, runde, bikonvekse tabletter mærket med 'PRU 2' på den ene side.
English: Resolor 2 mg film-coated tablets are pink round shaped tablets marked “PRU 2” on one side.
Danish: Resolor 2 mg filmovertrukne tabletter er lyserøde, runde tabletter mærket med 'PRU 2' på den ene side.
English: If pounding heart occurs, please tell your doctor.
Danish: Hvis du får kraftig hjertebanken, skal du sige det til din læge.
English: At week 12, 68.3% of patients treated with 2 mg prucalopride had an average increase of ≥1 SBM/week versus 37.0% of placebo patients (p<0.001 vs placebo).
Danish: Ved uge 12 havde 68,3 % af patienterne i behandling med 2 mg prucaloprid en gennemsnitlig stigning på ≥1 SBM/uge vs. 37,0 % af placebopatienterne (p<0,001 vs. placebo).
English: Similar results were observed at Week 12: 43.4%, 42.9%, and 31.7% respectively in 2 mg Resolor patients versus 26.9%, 27.2%, and 23.4% in placebo patients (p<0.001 vs placebo).
Danish: Tilsvarende resultater blev observeret ved uge 12: hhv. 43,4 %, 42,9 % og 31,7 % hos patienter i behandling med 2 mg Resolor vs. hhv. 26,9 %, 27,2 % og 23,4 % hos patienter på placebo (p<0,001 vs. placebo).
English: Renal excretion is the main route of elimination of prucalopride (see section 5.2).
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Eliminationen af prucaloprid sker hovedsagligt gennem renal udskillelse (se pkt.
English: Older people (>65 years): Start with 1 mg once daily (see section 5.2); if needed the dose can be increased to 2 mg once daily.
Danish: Ældre personer (> 65 år): Start med 1 mg én gang dagligt (se pkt.
English: The proportion of female patients in whom laxatives fail to provide adequate relief treated with the recommended dose of 2 mg Resolor (n=458) that reached an average of ≥3 SCBM per week was 31.0% (week 4) and 24.7% (week 12), versus 8.6% (week 4) and 9.2% (week 12) on placebo.
Danish: Andelen af kvindelige patienter, hvor laksantia ikke giver tilstrækkelig lindring, som opnåede i gennemsnit ≥ 3 SCBM pr. uge, var 31,0 % (uge 4) og 24,7 % (uge 12) ved behandling med den anbefalede dosis på 2 mg Resolor (n=458) vs. 8,6 % (uge 4) og 9,2 % (uge 12) i placebogruppen.
English: At week 12, 68.3% of patients treated with 2 mg Resolor had an average increase of ≥1 SBM/week versus 37.0% of placebo patients (p<0.001 vs placebo).
Danish: Ved uge 12 havde 68,3 % af patienterne i behandling med 2 mg Resolor en gennemsnitlig stigning på ≥1 SBM/uge vs. 37,0 % af placebopatienterne (p<0,001 vs. placebo).
English: At week 4, the proportion of patients with an improvement of ≥1 versus baseline in the PAC-SYM abdominal, stool, and rectal symptom subscales was 41.3%, 41.6%, and 31.3% respectively in patients treated with Resolor 2 mg compared with 26.9%, 24.4% and 22.9% in patients on placebo.
Danish: Ved uge 4 var andelen af patienter med en forbedring på ≥1 vs. baseline i PAC-SYM-delskalaerne for abdominal-, afførings- og rektalsymptomer hhv. 41,3 %, 41,6 % og 31,3 % hos patienter i behandling med 2 mg Resolor, sammenlignet med hhv. 26,9 %, 24,4 % og 22,9 % hos patienter på placebo.
English: The difference between treatment groups in the average weekly frequency of ≥3 SCBMs per week was not statistically significant over Weeks 1-12 which is inconsistent with the 5 other multicentre, randomised, double-blind, 12-week placebo controlled studies demonstrating efficacy at this timepoint in adult patients.
Danish: Dette stemmer ikke overens med de 5 andre 12-ugers randomiserede, dobbeltblindede, placebokontrollerede multicenterstudier, der påviste effekt på dette tidspunkt hos voksne patienter.
English: White to off-white, round, biconvex tablets marked “PRU 1” on one side.
Danish: Hvide til råhvide, runde, bikonvekse tabletter mærket med 'PRU 1' på den ene side.
English: Vomiting, dyspepsia, flatulence, gastrointestinal sounds abnormal
Danish: Opkastning, dyspepsi, flatulens, unormale tarmlyde
English: Resolor 1 mg film-coated tablets Resolor 2 mg film-coated tablets prucalopride
Danish: Resolor 1 mg filmovertrukne tabletter Resolor 2 mg filmovertrukne tabletter prucaloprid
English: When breast-feeding, prucalopride can pass into breast milk.
Danish: Prucaloprid kan udskilles i mælken ved amning.
English: Rectal haemorrhage
Danish: Nedsat nyrefunktion
English: One film-coated tablet of Resolor 2 mg contains 2 mg prucalopride (as succinate).
Danish: Én filmovertrukken tablet Resolor 2 mg indeholder 2 mg prucaloprid (som succinat).
English: One film-coated tablet of Resolor 1 mg contains 1 mg prucalopride (as succinate).
Danish: Én filmovertrukken tablet Resolor 1 mg indeholder 1 mg prucaloprid (som succinat).
English: Tablet coating
Danish: Tabletovertræk:
English: Resolor 2 mg film-coated tablets
Danish: Resolor 2 mg filmovertrukne tabletter
English: What Resolor looks like and contents of the pack Resolor 1 mg film-coated tablets are white to off-white round shaped tablets marked “PRU 1” on one side.
Danish: Resolor 1 mg filmovertrukne tabletter er hvide til råhvide, runde tabletter mærket med 'PRU 1' på den ene side.
English: At therapeutic doses of Resolor, no effects on breast-fed newborns/infants are anticipated.
Danish: Der forventes ingen påvirkning af nyfødte børn/spædbørn ammet af kvinder, der har taget terapeutiske doser af Resolor.
English: Resolor 2 mg tablets prucalopride
Danish: Resolor 2 mg tabletter prucaloprid
English: Resolor 1 mg tablets prucalopride
Danish: Resolor 1 mg tabletter prucaloprid
English: Incidence Category
Danish: Bivirkning
English: Resolor 1 mg film-coated tablets.
Danish: Resolor 1 mg filmovertrukne tabletter
English: What Resolor is and what it is used for What you need to know before you take Resolor How to take Resolor
Danish: Det skal du vide, før du begynder at tage Resolor Sådan skal du tage Resolor Bivirkninger
English: Each film-coated tablet contains 2 mg prucalopride (as succinate).
Danish: Hver filmovertrukken tablet indeholder 2 mg prucaloprid (som succinat).
English: Each film-coated tablet contains 1 mg prucalopride (as succinate).
Danish: Hver filmovertrukken tablet indeholder 1 mg prucaloprid (som succinat).
English: Resolor 2 mg film-coated tablets prucalopride
Danish: Resolor 2 mg filmovertrukne tabletter prucaloprid
English: Resolor 1 mg film-coated tablets prucalopride
Danish: Resolor 1 mg filmovertrukne tabletter prucaloprid
English: EU/1/09/581/004 (7 tablets) EU/1/09/581/006 (14 tablets) EU/1/09/581/002 (28 tablets) EU/1/09/581/008 (84 tablets)
Danish: EU/1/09/581/004 (7 tabletter) EU/1/09/581/006 (14 tabletter) EU/1/09/581/002 (28 (tabletter) EU/1/09/581/008 (84 tabletter)
English: EU/1/09/581/001 (28 tablets) EU/1/09/581/003 (7 tablets) EU/1/09/581/005 (14 tablets) EU/1/09/581/007 (84 tablets)
Danish: EU/1/09/581/001 (28 tabletter) EU/1/09/581/003 (7 tabletter) EU/1/09/581/005 (14 tabletter) EU/1/09/581/007 (84 tabletter)
English: EU/1/09/581/002 (28 tablets) EU/1/09/581/004 (7 tablets) EU/1/09/581/006 (14 tablets) EU/1/09/581/008 (84 tablets)
Danish: EU/1/09/581/002 (28 tabletter) EU/1/09/581/004 (7 tabletter) EU/1/09/581/006 (14 tabletter) EU/1/09/581/008 (84 tabletter)
English: EU/1/09/581/003 (7 tablets) EU/1/09/581/005 (14 tablets) EU/1/09/581/001 (28 tablets) EU/1/09/581/007 (84 tablets)
Danish: EU/1/09/581/001 (7 tabletter) EU/1/09/581/003 (14 tabletter) EU/1/09/581/001 (28 tabletter) EU/1/09/581/007 (84 tabletter)
English: Iffeza 50 Mikrogramm/5 Mikrogramm pro Sprühstoß Druckgasinhalation
Danish: Iffeza 50 Mikrogramm/5 Mikrogramm pro Sprühstoß
English: Iffeza 125 Mikrogramm/5 Mikrogramm pro Sprühstoß Druckgasinhalation
Danish: Iffeza 125 Mikrogramm/5 Mikrogramm pro Sprühstoß
English: Iffeza 250 Mikrogramm/10 Mikrogramm pro Sprühstoß Druckgasinhalation
Danish: Mikrogramm/10 Mikrogramm pro Sprühstoß Druckgasinhalation
English: 10 bottles Zero days
Danish: 10 hætteglas 0 dage
English: 10 glass vials
Danish: 10 flasker
English: An updated version of the Risk Management Plan will be submitted to National Competent Authorities within 3 months of the Commission Decision for this procedure, to reflect the updated information on the paediatric population as agreed by CHMP.
Danish: Der skal indsendes en opdateret version af risikostyringsplanen til de nationale kompetente myndigheder senest tre måneder efter Kommissionens afgørelse for denne procedure for at afspejle den opdaterede information vedrørende den pædiatriske population, som vedtaget af CHMP.
English: Conditions of the marketing authorisations
Danish: Betingelser for markedsføringstilladelserne
English: National Competent Authorities (NCAs), coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders (MAHs):
Danish: De nationale kompetente myndigheder skal sikre, at følgende betingelser bliver opfyldt af indehaverne af markedsføringstilladelserne, om relevant under koordination af referencemedlemsstaten.
English: *p-value refers to comparison between arms.
Danish: * p-værdi henviser til sammenligning mellem arme.
English: You should usually receive your infusion once every 3 weeks.
Danish: Du vil normalt få infusionen én gang hver 3. uge.
English: • Stable disease (%)
Danish: • Stabil sygdom (%)
English: *Definition of frequency terms: Very common - ≥ 10%; Common - > 5% and < 10%.
Danish: * Definition af hyppighed: Meget almindelig - ≥ 10 %; Almindelig > 5 % og < 10 %.
English: This is equivalent to 2.7% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 2,7 % af den anbefalede maximale daglige indtagelse af natrium for en voksen.
English: In the absence of other compatibility studies this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
English: Fisher's exact pvalue*
Danish: Fishers eksakte pniveau*
English: • Non-inferiority p-value (HR)
Danish: • P-værdi for non-inferioritet (HR)
English: Each box contains one vial.
Danish: Hver æske indeholder ét hætteglas.
English: ** which is derived from the term “renal/genitourinary other”.
Danish: ** som stammer fra udtrykket ”andre renale/genitourinære faktorer”.