FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant use with strong CYP3A inhibitors and inducers Concomitant use of naldemedine with strong CYP3A inhibitors (e.g. grapefruit juice, itraconazole, ketoconazole, ritonavir, indinavir, saquinavir, telithromycin and clarithromycin) leads to an increase in naldemedine exposure and may increase the risk of adverse reactions.
Danish: Anvendelse sammen med potente CYP3A-hæmmere og -induktorer Anvendelse af naldemedin sammen med potente CYP3A-hæmmere (f.eks. grapefrugtjuice, itraconazol, ketoconazol, ritonavir, indinavir, saquinavir, telithromycin og clarithromycin) fører til en øget eksponering for naldemedin og kan øge risikoen for bivirkninger.
English: Plasma concentrations of naldemedine in subjects with ESRD requiring dialysis were similar when naldemedine was administered either pre- or post-haemodialysis, indicating that naldemedine was not removed from the blood by haemodialysis.
Danish: Plasmakoncentrationerne af naldemedin hos forsøgspersoner med ESRD med behov for dialyse var ens, hvad enten naldemedin blev administreret før eller efter hæmodialyse.
English: If used with moderate CYP3A inhibitors, monitor for adverse reactions.
Danish: Hvis det anvendes sammen med moderate CYP3A-hæmmere, skal der overvåges for bivirkninger.
English: In Study V9235, the three most common types of pain were back pain (58.0%); osteoarthritis (9.5%) and neck pain (8.1%).
Danish: I studie V9235 var de tre mest almindelige former for smerter rygsmerter (58,0 %), osteoartritis (9,5 %) og nakkesmerter (8,1 %).
English: Change in frequency of SBMs without straining per week (LS Mean)
Danish: Ændring i hyppighed af SBM'er uden der kræves anstrengelse pr. uge (LS gennemsnit)
English: Naldemedine (N=97)
Danish: Naldemedin (N=97)
English: CI=Confidence Interval *Statistically significant: p-values based on the Cochran-Mantel-Haenszel test. ** p<0.0001 *** p=0.0003 for study V9231 and p=0.0011 for study V9232
Danish: ** p<0,0001 *** p=0,0003 for studie V9231 og p=0,0011 for studie V9232
English: Naldemedine (N=58)
Danish: Naldemedin (N=58)
English: In Study V9231, the three most common types of pain were back pain (62.0%); neck pain (8.3%) and osteoarthritis (5.3%).
Danish: I studie V9231 var de tre mest almindelige former for smerter rygsmerter (62,0 %), nakkesmerter (8,3 %) og osteoartritis (5,3 %).
English: Concomitant use of naldemedine with strong CYP3A inducers (e.g. St. John's wort (Hypericum perforatum), rifampicin, carbamazepine, phenobarbital and phenytoin) leads to a decrease in naldemedine exposure and may reduce the efficacy of naldemedine.
Danish: Anvendelse af naldemedin sammen med potente CYP3A-induktorer (f.eks. prikbladet perikon (Hypericum perforatum), rifampin, carbamazepin, phenobarbital og phenytoin) fører til en reduktion i eksponeringen for naldemedin og kan reducere naldemedins virkning.
English: • watery eyes or runny nose
Danish: • øjne, der løber i vand, eller næseflåd
English: Naldemedine must not be used in patients with known or suspected gastrointestinal obstruction or in patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.
Danish: Naldemedin må ikke anvendes til patienter med kendt eller mistænkt mave-tarmobstruktion eller til patienter med en øget risiko for tilbagevendende obstruktion på grund af muligheden for en mave-tarm-perforation.
English: Patients with known or suspected gastrointestinal obstruction or perforation or patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation (see section 4.4).
Danish: Patienter med kendt eller formodet mave-tarm-obstruktion eller -perforation eller patienter med en øget risiko for tilbagevendende obstruktion på grund af risikoen for mave-tarm-perforation (se pkt.
English: Naldemedine should not be used during breast-feeding.
Danish: Naldemedin må ikke anvendes under amning.
English: Gastrointestinal perforation
Danish: Mave-tarm-perforation
English: The pharmacokinetics of naldemedine after administration of a single 200 microgram dose of naldemedine was studied in subjects with mild, moderate or severe renal impairment, or with endstage renal disease (ESRD) requiring haemodialysis, and compared with healthy subjects with normal renal function.
Danish: Farmakokinetikken for naldemedin efter administration af en enkelt 200 mikrogram dosis af naldemedin blev undersøgt hos forsøgspersoner med let, moderat eller svært nedsat nyrefunktion eller med nyresygdom i slutstadiet (end-stage renal disease, ESRD) med behov for hæmodialyse, og den blev sammenlignet med kinetikken hos raske forsøgspersoner med normal nyrefunktion.
English: The use of naldemedine is not recommended in these patients (see section 4.2).
Danish: Naldemedin bør ikke anvendes hos disse patienter (se pkt.
English: The peak plasma concentration and area under the plasma concentration-time curve increased in an almost dose-proportional manner within the dose range of 0.1 to 100 mg. A slight accumulation
Danish: Den maksimale plasmakoncentration og arealet under kurven over plasmakoncentration som funktion af tiden steg næsten dosisproportionalt inden for dosisintervallet fra 0,1 til 100 mg. Der blev observeret en let akkumulation (1 til 1,3-gange) for den maksimale plasmakoncentration og arealet under kurven over plasmakoncentration som funktion af tiden efter flere administrationer af én daglig dosis i fastende tilstand i 10 dage.
English: • nausea (feeling sick) or vomiting
Danish: • kvalme eller opkastning
English: Possible side effects
Danish: Skema over bivirkninger
English: In studies V9222 and V9236, OIC was confirmed through a 2-week run-in period and was defined as ≤5 SBMs during the 14 consecutive days prior to the randomisation and ≥1 of the following bowel symptoms in ≥25% of all BMs regardless of the use of rescue laxatives: presence of straining during bowel movement, feeling of incomplete evacuation, passage of hard stools or small pellets.
Danish: ≤5 SBM'er i løbet af 14 på hinanden følgende dage før randomisering og ≥1 af de følgende tarmsymptomer ved ≥25 % af alle BM'er uanset brugen af behovsafføringsmidler: anstrengelse ved afføring, følelse af ufuldstændig udtømning, passage af hård afføring eller små knolde.
English: • feeling depressed
Danish: • depression
English: Each film-coated tablet contains 200 micrograms naldemedine (as tosylate).
Danish: Hver filmovertrukket tablet indeholder 200 mikrogram naldemedin (som tosylat).
English: The pharmacokinetics of naldemedine between subjects with mild, moderate or severe renal impairment, or subjects with ESRD requiring hemodialysis and healthy subjects with normal renal function were similar.
Danish: Farmakokinetikken for naldemedin hos forsøgspersoner med let, moderat eller svært nedsat nyrefunktion eller forsøgspersoner med ESRD med behov for hæmodialyse svarede til den hos raske forsøgspersoner med normal nyrefunktion.
English: Croscarmellose sodium Magnesium stearate
Danish: Tabletkerne Mannitol (E421) Croscarmellosenatrium Magnesiumstearat
English: Naldemedine is not removed from the body by haemodialysis.
Danish: Naldemedin fjernes ikke fra kroppen ved hæmodialyse.
English: - Each tablet contains 200 micrograms of naldemedine (as tosylate).
Danish: - Hver tablet indeholder 200 mikrogram naldemedin (som tosylat).
English: Naldemedine must not be used in patients with known or suspected GI obstruction or in patients at increased risk of recurrent obstruction, due to the potential for GI perforation (see section 4.3).
Danish: Naldemedin må ikke anvendes til patienter med kendt eller mistænkt mave-tarm-obstruktion eller til patienter med en øget risiko for tilbagevendende obstruktion på grund af muligheden for en mavetarm-perforation (se pkt.
English: • pupils dilating
Danish: • udvidede pupiller
English: How to take Rizmoic
Danish: Sådan skal du tage Rizmoic
English: Each tablet contains 200 micrograms naldemedine (as tosylate).
Danish: Hver tablet indeholder 200 mikrogram naldemedin (som tosylat).
English: Abdominal paina
Danish: Abdominalsmertera
English: • achy muscles
Danish: • smertende muskler
English: Naldemedine (N=621)
Danish: Naldemedin (N=621)
English: • If you experience a serious allergic reaction, stop taking Rizmoic and see a doctor or go to a hospital straight away.. Serious allergic reactions include: swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty swallowing or breathing, itching of the skin and nettle rash.
Danish: Alvorlige allergiske reaktioner omfatter: hævelse af hænder, fødder, ankler, ansigt, læber eller halsen, som kan forårsage synkebesvær eller vejrtrækningsproblemer, hudkløe og nældefeber.
English: • inability to sleep
Danish: • søvnløshed
English: Naldemedine (N=276)
Danish: Naldemedin (N=276)
English: Change in frequency of CSBMs per week (LS Mean)
Danish: Ændring i hyppighed af SBM'er pr. uge (Mindste kvadraters (LS) gennemsnit)
English: If use with strong CYP3A inhibitors is unavoidable, monitor for adverse reactions (see section 4.4).
Danish: Hvis det ikke kan undgås at anvende naldemedin sammen med potente CYP3A-hæmmere, skal der overvåges for bivirkninger (se pkt.
English: If you are not sure, talk to your doctor or pharmacist before taking Rizmoic.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Rizmoic, hvis du er i tvivl.
English: The pharmacokinetics of naldemedine between subjects with mild or moderate hepatic impairment and healthy subjects with normal hepatic function were similar.
Danish: Farmakokinetikken for naldemedin hos forsøgspersoner med let eller moderat nedsat leverfunktion svarede til farmakokinetikken hos raske forsøgspersoner med normal leverfunktion.
English: • a stomach ulcer;
Danish: • mavesår,
English: Mean frequency of BMs at baseline Change in the Frequency of BMs per week Week 12* Week 24* Week 36* Week 52* *nominal p≤0.0001
Danish: Uge 12* Uge 24* Uge 36* Uge 52*
English: What Rizmoic is and what it is used for What you need to know before you take Rizmoic How to take Rizmoic
Danish: Det skal du vide, før du begynder at tage Rizmoic Sådan skal du tage Rizmoic Bivirkninger
English: Use in patients with severe hepatic impairment is not recommended (see sections 4.4 and 5.2).
Danish: Bør ikke anvendes til patienter med svært nedsat leverfunktion (se pkt.
English: Rizmoic 200 micrograms film-coated tablets naldemedine
Danish: Rizmoic 200 mikrogram filmovertrukne tabletter naldemedin
English: Rizmoic 200 micrograms tablets naldemedine
Danish: Rizmoic 200 mikrogram tabletter naldemedin
English: In Studies V9231, V9232 and V9235, the mean age of the subjects in these three studies was 53.2 years; 14.8% were 65 years of age or older; 62.0% were women; 80.2% were white.
Danish: 14,8 % var 65 år eller ældre, 62,0 % var kvinder, og 80,2 % var af hvid herkomst.
English: Name and address of the manufacturers responsible for batch release Manufacturing Packaging Farmaca (MPF) bv Appelhof 13
Danish: Manufacturing Packaging Farmaca (MPF) bv Appelhof 13
English: Naldemedine (N=273)
Danish: Naldemedin (N=273)
English: If you take more Rizmoic than you should
Danish: Hvis du har taget for meget Rizmoic
English: Hepatic impairment
Danish: Kvalme Opkastning
English: Breast-feeding
Danish: • svedtendens
English: However, there was no significant difference during the maintenance phase.
Danish: Imidlertid var der ingen signifikant forskel i vedligeholdelsesfasen.
English: * if needed
Danish: * hvis det er nødvendigt
English: This reduces the risk of worsening symptoms.
Danish: Dette mindsker risikoen for, at symptomerne forværres.
English: Date of latest renewal: 26 August 2013
Danish: Dato for seneste fornyelse: 26. august 2013
English: Frequency cannot be estimated from the available data
Danish: Hyppigheden kan ikke estimeres ud fra forhåndenværende data
English: Date of first authorisation: 18 December 2008
Danish: Dato for første markedsføringstilladelse: 18. december 2008
English: The relevance for humans is unknown.
Danish: Relevansen for mennesker er ukendt.
English: In this case, you will have to take the tablets only once or twice a day.
Danish: I det tilfælde skal du kun tage tabletterne én eller to gange dagligt.
English: Lowest maintenance dose Highest maintenance dose
Danish: Laveste vedligeholdelsesdosis Højeste vedligeholdelsesdosis
English: You should tell your doctor if this occurs.
Danish: Fortæl det til din læge, hvis dette sker.
English: Ask your doctor for advice.
Danish: Spørg din læge om råd.
English: In open continuation trials lasting for more than three years there were no signs of decreasing efficacy.
Danish: I fortsatte, åbne undersøgelser over mere end 3 år var der ikke tegn på aftagende virkning.
English: The frequency category is probably not greater than “uncommon”.
Danish: Hyppighedskategorien er formentlig ikke større end "ikke almindelig".
English: Mania and delirium
Danish: Mani og delirium
English: Body System Very common
Danish: Kropssystem Meget almindelig
English: The absolute bioavailability is greater than 90 % and the maximum plasma concentrations occur between 1 and 3 hours.
Danish: Den absolutte biotilgængelighed er større end 90 %, og maksimal plasmakoncentration opnås efter 1-3 timer.
English: This finding is not clinically relevant to man.
Danish: Dette fund er ikke klinisk relevant for mennesket.
English: Patients should be informed that (mostly visual) hallucinations can occur.
Danish: Patienterne bør informeres om, at hallucinationer (hyppigst visuelle) kan forekomme.
English: Hallucinations or somnolence can occur.
Danish: Der kan opstå hallucinationer eller somnolens.
English: 1 This side effect has been observed in post-marketing experience.
Danish: 1 Denne bivirkning er observeret efter markedsføring.
English: Pramipexole is rapidly and completely absorbed following oral administration.
Danish: Pramipexol absorberes hurtigt og fuldstændigt efter oral administration.
English: 747 70 Opava-Komarov Czech Republic
Danish: 305 747 70 Opava-Komarov Tjekkiet
English: You can then build up the dose again, as you did the first time.
Danish: Derefter kan din dosis sættes gradvis op igen på samme måde, som du gjorde første gang.
English: Furthermore a reduction of the dose or termination of therapy may be considered.
Danish: Yderligere kan en reduktion af dosis eller ophør med behandling overvejes.
English: Evaluation of these side effects is based on the following frequencies:
Danish: Inddelingen af disse bivirkninger er baseret på følgende hyppigheder: Meget almindelig:
English: Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly.
Danish: Pludseligt opstået søvn midt under daglige aktiviteter, i nogle tilfælde uden nogen form for advarsel, har sjældent været rapporteret.
English: Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
Danish: Interaktioner med andre lægemidler, der påvirker plasmaproteinbindingen eller elimineres ved biotransformation er derfor usandsynlig.
English: There is no clinical experience with massive overdose.
Danish: Der er ingen klinisk erfaring med massiv overdosering.
English: No studies on the effect on human fertility have been conducted.
Danish: Der er ikke gennemført studier over påvirkningen af human fertilitet.
English: The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
Danish: Eliminationens halveringstid (t½) varierer mellem 8 timer hos yngre og 12 timer hos ældre.
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal imidlertid fremsende periodiske, opdaterede sikkerhedsindberetninger (PSUR) for dette lægemiddel, såfremt lægemidlet bliver inkluderet på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: With 95 % certainty, the frequency category is not greater than uncommon, but might be lower.
Danish: Med 95 % sikkerhed er frekvenskategorien ikke højere end "ikke almindelig" og kan være lavere.
English: Such effect was not observed in patient studies.
Danish: Der er ikke set en tilsvarende virkning i patientstudier.
English: Swallow the tablets with water.
Danish: Tabletterne bør synkes med vand.
English: Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
Danish: Patienter, som lider af psykotiske lidelser, bør kun behandles med dopaminagonister, hvis de potentielle fordele opvejer risikoen.
English: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Danish: TEVA UK Ltd. Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG UK
English: Plasma protein binding
Danish: Plasmaproteinbinding
English: If you stop taking your tablets for more than a few days and want to restart the treatment, you must start again at the lowest dose.
Danish: Hvis du holder op med at tage tabletterne i mere end et par dage og ønsker at begynde igen, skal du igen begynde med den laveste dosis.
English: Patients should be informed about this before tapering the dopamine agonist, and monitored regularly thereafter.
Danish: Patienter skal informeres herom inden nedtrapning af dopaminagonisten og monitoreres regelmæssigt derefter.
English: Neuroleptic malignant syndrome
Danish: Neuroleptisk malignt syndrom
English: The doctor will advise you on the right dosing.
Danish: Lægen vil rådgive dig om doseringen.
English: If the problems persist more than a few weeks, your doctor may need to adjust your treatment.
Danish: Hvis problemet varer længere end et par uger, skal din læge muligvis justere din behandling.
English: As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
Danish: Da antikolinergika hovedsageligt elimineres via biotransformation, er den potentielle risiko for interaktion begrænset, selvom interaktion med antikolinergika ikke er blevet undersøgt.
English: In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma.
Danish: Hos rotter var koncentrationen af radioaktivitet forbundet med det aktive stof højere i modermælk end i plasma.
English: • Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
Danish: • Manglende evne til at modstå trangen eller fristelsen til at udføre en handling, der kan være skadelig for dig selv eller andre, og som kan omfatte:
English: If they occur, the dose of levodopa should be decreased.
Danish: Opstår der sådanne, så bør dosis af levodopa reduceres.
English: The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
Danish: Sidstnævnte fund blev hverken observeret hos pigmenterede rotter eller i albinomus i et karcinogenstudie over 2 år eller hos nogen anden undersøgt dyreart.
English: Kaplan-Meier analysis of time to augmentation showed no significant difference between pramipexole and placebo groups.
Danish: Kaplan-Meier-analyse af tid til augmentation viste ingen signifikant forskel mellem pramipexol- og placebogruppen.
English: The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
Danish: Den potentielle virkning af pramipexol på den reproduktive funktion er blevet undersøgt hos rotter og kaniner.
English: If this happens, your doctor may want to adjust or change your medication.
Danish: Hvis dette sker, kan det være, at lægen vil justere eller ændre din medicin.
English: Pramipexole was not genotoxic.
Danish: Pramipexol var ikke genotoksisk.
English: Dose reduction/tapered discontinuation should be considered if such symptoms develop.
Danish: Dosisreduktion/gradvis seponering bør overvejes, hvis sådanne symptomer opstår.
English: It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of postural hypotension associated with dopaminergic therapy.
Danish: Det anbefales at monitorere blodtrykket, særligt i starten af behandlingen, hvilket skyldes den generelle risiko for postural hypotension i forbindelse med dopaminbehandling.
English: Further dose adjustments should be done based on the clinical response and the occurrence of adverse reactions.
Danish: Yderligere dosisjusteringer bør foretages på basis af klinisk respons og forekomst af bivirkninger.
English: It can be used alone or in combination with levodopa (another medicine for Parkinson's disease).
Danish: Det kan tages alene eller sammen med levodopa (medicin til behandling af Parkinsons sygdom).
English: • Strong impulse to gamble excessively despite serious personal or family consequences.
Danish: • Stærk trang til at spille (sygelig spilletrang) trods alvorlige personlige og familiemæssige konsekvenser.
English: Pharmacotherapeutic group: anti-Parkinson drugs, dopamine agonists, ATC code: N04BC05
Danish: Farmakoterapeutisk klassifikation: Anti-Parkinson-lægemiddel, dopaminagonister, ATC-kode: N04BC05
English: Tell your doctor if you experience any of these behaviours; he will discuss ways of managing or reducing the symptoms.
Danish: Fortæl din læge, hvis du oplever et sådant adfærdsmønster; han vil diskutere måder til at håndtere eller mindske symptomerne.
English: Combination with levodopa
Danish: Kombination med levodopa
English: Out of these, approximately 1,000 were in more advanced stages, received concomitant levodopa therapy, and suffered from motor complications.
Danish: Ud af disse var ca. 1.000 på mere avancerede stadier, de fik ledsagende levodopaterapi og led af motoriske komplikationer.
English: Very common: • Nausea (sickness)
Danish: Meget almindelig: • Kvalme
English: • Abnormal dreams
Danish: • Unormale drømme
English: Therefore, do not take Pramipexole Teva if you are pregnant unless your doctor tells you to do so.
Danish: Derfor bør du ikke tage Pramipexol Teva, hvis du er gravid, medmindre din læge anbefaler dig at gøre det.
English: Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements.
Danish: Stimulation af dopaminreceptorerne påvirker nerveimpulser i hjernen, som kontrollerer kroppens bevægelser.
English: GALIEN LPS 98 rue Bellocier 89100 Sens France
Danish: GALIEN LPS 98 rue Bellocier 89100 Sens Frankrig
English: Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.
Danish: Patienter som har oplevet somnolens og/eller en episode med pludseligt opstået søvnanfald, må ikke køre bil eller betjene maskiner.
English: Longer term efficacy was evaluated in a placebo-controlled clinical trial.
Danish: Langtidsvirkningen blev evalueret i et placebokontrolleret klinisk forsøg.
English: The effect on pregnancy and lactation has not been investigated in humans.
Danish: Virkningen på graviditet og amning er ikke blevet undersøgt hos mennesker.
English: Reports in the literature indicate that treatment of Restless Legs Syndrome with dopaminergic medicinal products can result in augmentation.
Danish: Rapporter fra litteraturen indikerer, at behandling af restless legs syndrom med dopaminerge lægemidler kan resultere i augmentation.
English: Restless Legs Syndrome The dose is usually taken once a day, in the evening, 2-3 hours before bedtime.
Danish: Restless legs syndrom (RLS) Den sædvanlige dosis tages almindeligvis én gang dagligt, 2-3 timer før sengetid.
English: Pramipexole Teva should not be used during pregnancy unless clearly necessary, i.e. if the potential benefit justifies the potential risk to the foetus.
Danish: Pramipexol Teva bør ikke anvendes under graviditeten, medmindre det er strengt nødvendigt, f.eks. hvis den potentielle gavn retfærdiggør den potentielle risiko for fostret.