FrancophonIA/ELRC3.0 huggingface dataset:
English: In the Phase III studies that established safety and efficacy of SIFROL prolonged-release tablets, patients were instructed to take study medication without regard to food intake.
Danish: I de fase-III-studier, hvor sikkerhed og virkning af Sifrol depottabletter blev undersøgt, blev patienterne instrueret i at tage studiemedicinen uden hensyntagen til fødeindtagelse.
English: The use of SIFROL has not been studied in haemodialysis patients, or in patients with severe renal impairment.
Danish: Brugen af Sifrol har ikke været undersøgt hos hæmolysepatienter eller hos patienter med svært nedsat nyrefunktion.
English: What SIFROL contains
Danish: SIFROL indeholder:
English: SIFROL should not be used in children or adolescents with Tourette Disorder because of a negative benefit-risk balance for this disorder (see section 5.1).
Danish: Sifrol bør ikke anvendes til børn og unge med Tourettes sygdom på grund af en negativ balance mellem fordele og ulemper ved denne sygdom (se pkt.
English: If you stop taking SIFROL
Danish: Hvis du holder op med at tage SIFROL
English: SIFROL prolonged-release tablets is a specially designed tablet from which the active ingredient is gradually released, once the tablet has been ingested.
Danish: SIFROL depottabletter er specialfremstillede tabletter, hvor det aktive stof langsomt frigives efter indtagelse af tabletten.
English: Some patients have reported the occurrence of remnants in faeces which may resemble intact SIFROL prolonged-release tablets.
Danish: Nogle patienter har rapporteret om rester i afføringen, der kan ligne intakte Sifrol depottabletter.
English: In the absence of human data, SIFROL should not be used during breast-feeding.
Danish: På grund af mangel på humane data må Sifrol ikke anvendes under amning.
English: Then take your SIFROL prolonged-release tablets next morning and do not take any more SIFROL (immediate release) tablets.
Danish: Tag SIFROL depottabletter den næste morgen, og tag så ikke flere almindelige SIFROL tabletter.
English: If you forget to take SIFROL
Danish: Hvis du har glemt at tage SIFROL
English: Not known: - After stopping or reducing your SIFROL treatment: Depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).
Danish: Ikke kendt: - Efter at du er stoppet med eller har nedsat dosis i din SIFROL-behandling: Depression, apati, angst, træthed, svedtendens eller smerter kan forekomme (kaldet dopaminagonistabstinenssyndrom eller dopamine agonist withdrawal syndrome - DAWS).
English: Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly with SIFROL.
Danish: Det bør overvejes at nedsætte pramipexoldosis i tilfælde, hvor disse lægemidler administreres samtidigt med Sifrol.
English: It can be used alone or in combination with levodopa (another medicine for Parkinson's disease).
Danish: SIFROL kan tages alene eller i kombination med levodopa (medicin til behandling af Parkinsons sygdom)
English: SIFROL prolonged-release tablets are a once-a-day oral formulation of pramipexole.
Danish: Sifrol depottabletter er én-gang-daglig oral formulering af pramipexol.
English: However, in Phase III trials in Parkinson's disease patients no clinically meaningful influence of body weight on the therapeutic effect and tolerability of SIFROL prolonged-release tablets was detected.
Danish: I fase-III studier hos Parkinsons patienter blev det ikke observeret, at kropsvægt har nogen klinisk relevant påvirkning på den terapeutiske virkning og tolerabiliteten af Sifrol depottabletter.
English: Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your SIFROL treatment.
Danish: Fortæl din læge, hvis du oplever symptomer såsom depression, apati, angst, træthed, svedtendens eller smerter, efter at du er stoppet med eller har nedsat dosis i din SIFROL-behandling.
English: Only one patient switched to SIFROL prolonged-release tablets experienced a drug-related adverse event leading to withdrawal.
Danish: Kun en patient, som skiftede til Sifrol depottabletter, fik en lægemiddelrelateret bivirkning, der medførte seponering.
English: However, the potential influence of hepatic insufficiency on SIFROL pharmacokinetics has not been investigated.
Danish: Den potentielle indflydelse af nedsat leverfunktion på Sifrols farmakokinetik kendes ikke.
English: In a placebo-controlled polysomnography study over 3 weeks SIFROL significantly reduced the number of periodic limb movements during time in bed.
Danish: I et placebo-kontrolleret polysomnografi-studie over 3 uger reducerede Sifrol signifikant antallet af periodiske benbevægelser, mens forsøgspersonerne var sengeliggende.
English: SIFROL prolonged-release tablets were non-inferior to pramipexole immediate release tablets as assessed on the UPDRS Parts II+III score at week 33.
Danish: Sifrol depottabletter var non-inferior i forhold til pramipexoltabletter vurderet ud fra UPDRS del II+III score ved uge 33.
English: The safety and efficacy of SIFROL prolonged-release tablets in the treatment of Parkinson's disease was evaluated in a multinational drug development program consisting of three randomised, controlled trials.
Danish: Sikkerhed og virkning af Sifrol depottabletter ved behandling af Parkinsons sygdom blev undersøgt i et multinationalt klinisk udviklingsprogram bestående af 3 randomiserede, kontrollerede studier.
English: The treatment of patients with a creatinine clearance below 30 ml/min with SIFROL prolonged-release tablets is not recommended as no data are available for this patient population.
Danish: Ved kreatininclearance mindre end 30 ml/min anbefales det ikke at anvende Sifrol depottabletter, da der ikke findes data for denne patientpopulation.
English: The maximum plasma concentrations occur at about 6 hours after administration of SIFROL prolonged-release tablets once daily.
Danish: Den maksimale plasmakoncentration opnås ca. 6 timer efter administration af Sifrol depottabetter givet en gang daglig.
English: SIFROL can have a major influence on the ability to drive and use machines.
Danish: Sifrol kan påvirke evnen til at føre motorkøretøj og betjene maskiner i væsentlig grad.
English: Do not stop taking SIFROL without first talking to your doctor.
Danish: Du må ikke holde op med at tage SIFROL uden at spørge din læge til råds.
English: When SIFROL is given in combination with levodopa, it is recommended that the dose of levodopa is reduced and the dose of other anti-parkinsonian medicinal products is kept constant while increasing the dose of SIFROL.
Danish: Når Sifrol gives i kombination med levodopa, anbefales det at reducere levodopa-dosis og at holde dosis af andre antiparkinson-lægemidler konstant, mens dosis af Sifrol øges.
English: SIFROL with food, drink and alcohol You should be cautious while drinking alcohol during treatment with SIFROL.
Danish: Brug af SIFROL sammen med mad, drikke og alkohol Ved behandling med SIFROL, skal du være forsigtig med indtagelse af alkohol, da din reaktionsevne kan blive markant nedsat.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with SIFROL in one or more subsets of the paediatric population in Restless Legs Syndrome (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Sifrol i en eller flere undergrupper af den pædiatriske population med restless legs syndrom (se pkt.
English: SIFROL can reduce the production of breast milk.
Danish: SIFROL kan nedsætte mælkeproduktionen og kan også overføres til din baby via brystmælk.
English: SIFROL should not be used during breast-feeding.
Danish: SIFROL må ikke anvendes under amning.
English: Other medicines and SIFROL
Danish: Brug af anden medicin sammen med SIFROL
English: Tell your doctor if you or your family/carer notices that you are developing mania (agitation, feeling elated or over-excited) or delirium (decreased awareness, confusion, loss of reality).
Danish: Fortæl din læge, hvis du eller din familie/pårørende bemærker, at du er ved at udvikle mani (føle sig oprørt, opstemt eller ophidset) eller delirium (nedsat bevidsthed, forvirring eller manglende realitetsopfattelse).
English: The efficacy and tolerability of an overnight switch from SIFROL tablets to SIFROL prolongedrelease tablets at the same daily dose were evaluated in a double-blind clinical study in patients with early Parkinson's disease.
Danish: Virkningen og tolerabiliteten hos patienter, som fra dag til dag skiftede behandling fra Sifrol tabletter til Sifrol depottabletter, blev undersøgt i et dobbelblindt klinisk studie hos patienter med tidlig udvikling af Parkinsons sygdom.
English: Patients being treated with SIFROL and presenting with somnolence and/or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until such recurrent episodes and somnolence have resolved (see also sections 4.4, 4.5 and 4.8).
Danish: Patienter, som bliver behandlet med Sifrol, og som har oplevet døsighed, somnolens og/eller episoder med pludseligt opstået søvn, bør informeres om, at de skal afstå fra at køre bil eller deltage i aktiviteter, hvor nedsat årvågenhed kan udsætte dem eller andre for alvorlig fare eller død (f.eks. betjening af maskiner), indtil sådanne tilbagevendende episoder, døsighed og/eller somnolens er ophørt (se også pkt.
English: SIFROL is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).
Danish: Sifrol er indiceret til voksne til symptomatisk behandling af moderat til svær idiopatisk restless legs syndrom i doser op til 0,54 mg base (0,75 mg salt) (se pkt.
English: Common (≥1/100 to
Danish: Almindelig (≥1/100 til <1/10)
English: Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with SIFROL.
Danish: Patienterne bør informeres om dette, og rådes til forsigtighed ved bilkørsel og betjening af maskiner.
English: - Hallucinations (seeing, hearing or feeling things that are not there).
Danish: • Hallucinationer (at se, høre eller føle ting, som ikke er der)
English: - Psychosis (e.g. comparable with symptoms of schizophrenia).
Danish: • Psykoser (f.eks. som ved symptomer på skizofreni)
English: Ascending dose schedule of SIFROL Week
Danish: Skema for dosisøgning af Sifrol Uge
English: In patients with a creatinine clearance between 30 and 50 ml/min, treatment should be started with 0.26 mg SIFROL prolonged-release tablets every other day.
Danish: Ved kreatininclearance mellem 30 og 50 ml/min bør behandlingen starte med 0,26 mg Sifrol depottabletter hver anden dag.
English: Swallow the tablets whole with water.
Danish: SIFROL tabletter skal synkes hele med vand.
English: Rare: - Mania (agitation, feeling elated or over-excited)
Danish: Sjælden: Mani (føle sig oprørt, opstemt eller ophidset)
English: In a clinical trial with healthy volunteers, where SIFROL prolonged-release tablets were titrated faster (every 3 days) than recommended up to 3.15 mg pramipexole base (4.5 mg of salt) per day, an increase in blood pressure and heart rate was observed.
Danish: I et klinisk studie med raske frivillige forsøgspersoner, hvor dosisjustering af Sifrol depottabletter var hurtigere (hver 3. dag) end anbefalet, op til 3,15 mg pramipexolbase (4,5 mg salt)/dag, blev der observeret en stigning i blodtrykket samt en forøgelse af hjerterytmen.
English: What SIFROL is and what it is used for
Danish: SIFROL bruges til
English: Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including SIFROL.
Danish: Patienter og pårørende bør informeres om, at adfærdsmæssige symptomer på manglende impulskontrol herunder ludomani, forøget libido, hyperseksualitet, tvangshandlinger, der fører til overdrevent indkøbsmønster og uhæmmet og overdreven madindtagelse, kan forekomme hos patienter i behandling med dopaminagonister, herunder Sifrol.
English: If you forget to take a dose of SIFROL, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Danish: Hvis du har glemt at tage en SIFROL dosis, men kommer i tanke om det indenfor 12 timer fra det sædvanlige tidspunkt, hvor du skulle have taget en dosis, skal du tage den sædvanlige tablet.
English: Patients already taking SIFROL tablets may be switched to SIFROL prolonged-release tablets overnight, at the same daily dose.
Danish: Patienter, der i forvejen tager Sifrol tabletter, kan fra dag til dag skifte til den samme daglige dosis af Sifrol depottabletter.
English: What you need to know before you take SIFROL
Danish: Det skal du vide, før du begynder at tage SIFROL
English: The European Medicines Agency has waived the obligation to submit the results of studies with SIFROL in all subsets of the paediatric population in Parkinson's Disease (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Sifrol i alle undergrupper af den pædiatriske population med Parkinsons sygdom (se pkt.
English: The safety and efficacy of SIFROL in children below 18 years has not been established.
Danish: Sifrols sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: SIFROL is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Danish: Sifrol anbefales ikke til børn og unge under 18 år p.g.a. manglende dokumentation for sikkerhed og virkning.
English: - Sleepiness and episodes of suddenly falling asleep.
Danish: • Søvnighed og episoder med pludseligt indsættende søvn
English: The tablets should be taken orally, swallowed with water, and can be taken either with or without food.
Danish: SIFROL tabletter bør synkes med vand, og kan både tages sammen med eller uden mad.
English: All tablets have the Boehringer Ingelheim company symbol embossed on one side and the codes P6, P7, P8, or P9 on the other side, representing the tablet strengths 0.088 mg, 0.18 mg, 0.35 mg, and 0.7 mg, respectively.
Danish: Alle tabletter har Boehringer Ingelheims firmalogo præget på den ene side og koden P6, P7, P8 eller P9 på den anden, hvilket repræsenterer tabletstyrker på henholdsvis 0,088 mg, 0,18 mg, 0,35mg og 0,7 mg.
English: There is no relevant use of SIFROL in the paediatric population for the indication of Parkinson's Disease.
Danish: Det er ikke relevant at anvende Sifrol hos den pædiatriske population ved indikationen Parkinsons sygdom.
English: The recommended starting dose of SIFROL is 0.088 mg of base (0.125 mg of salt) taken once daily 2-3 hours before bedtime.
Danish: Den anbefalede startdosis for Sifrol er 0,088 mg base (0,125 mg salt), som tages 1 gang dagligt 2-3 timer før sengetid.
English: When the intake of a dose is missed, SIFROL prolonged-release tablets should be taken within 12 hours after the regularly scheduled time.
Danish: Hvis patienten glemmer en dosis, bør Sifrol depottabletter tages indenfor 12 timer fra det sædvanlige tidspunkt.
English: SIFROL is not recommended for use in children and adolescents below 18 years since the efficacy and safety has not been established in this population.
Danish: Sifrol anbefales ikke til børn og unge under 18 år, da sikkerhed og virkning ikke er klarlagt hos denne population.
English: The daily dose should not exceed 6 tablets SIFROL 0.088 mg or a dose of 0.54 mg (0.75 mg pramipexole salt).
Danish: Den daglige dosis bør ikke overstige 6 SIFROL tabletter á 0,088 mg eller en dosis af 0,54 mg (0,75 mg pramipexolsalt)
English: In a double-blind placebo-controlled trial including a total of 517 patients with advanced Parkinson's disease who were on concomitant levodopa therapy superiority of SIFROL prolonged-release tablets over placebo was demonstrated after 18 weeks of treatment on both the primary (UPDRS Parts II+III score) and the key secondary (off-time) efficacy endpoints.
Danish: Et dobbeltblindet, placebokontrolleret studie med 517 patienter med fremskreden Parkinsons sygdom, som samtidig blev behandlet med levodopa, viste, at Sifrol depottabletter havde en bedre virkning (superior) end placebo efter 18 ugers behandling på både det primære (UPDRS del II+III) og vigtigste sekundære (off-time) endepunkter.
English: There is no relevant use of SIFROL prolonged-release tablets in the paediatric population for the indication of Parkinson's Disease.
Danish: Det er ikke relevant at anvende Sifrol depottabletter hos den pædiatriske population ved indikationen Parkinsons sygdom.
English: During the first week, the usual dose is 1 tablet SIFROL 0.088 mg three times a day (equivalent to 0.264 mg daily):
Danish: I den første uge er dosis oftest 1 SIFROL tablet á 0,088 mg tre gange dagligt (svarende til 0,264 mg om dagen):
English: Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements.
Danish: SIFROL påvirker nerveimpulser i hjernen, som kontrollerer kroppens bevægelser, ved at stimulere dopaminreceptorerne.
English: You can take SIFROL with or without food.
Danish: Du kan både tage dem sammen med eller uden mad.
English: SIFROL 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg and 3.15 mg prolonged-release tablets are white to offwhite and of oval shape.
Danish: SIFROL 1,05 mg, 1,57 mg, 2,1 mg, 2,62 mg og 3,15 mg depottabletter er hvide til råhvide og ovale.
English: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including SIFROL (see section 4.4).
Danish: Ludomani, forøget libido, hyperseksualitet og tvangshandlinger, der fører til overdrevent indkøbsmønster og uhæmmet og overdreven madindtagelse, kan forekomme hos patienter i behandling med dopaminagonister, herunder Sifrol (se pkt.
English: SIFROL contains the active substance pramipexole and belongs to a group of medicines known as dopamine agonists, which stimulate dopamine receptors in the brain.
Danish: SIFROL indeholder det aktive stof pramipexol, der er en såkaldt dopaminagonist, som stimulerer specielle receptorer i hjernen (dopaminreceptorerne).
English: SIFROL 0.18 mg tablets and SIFROL 0.35 mg tablets are white, of oval shape, and flat.
Danish: SIFROL 0,18 mg og SIFROL 0,35 mg er hvide, ovale og flade tabletter.
English: In patients with a creatinine clearance between 20 and 50 ml/min, the initial daily dose of SIFROL should be administered in two divided doses, starting at 0.088 mg of base (0.125 mg of salt) twice a day (0.176 mg of base/0.25 mg of salt daily).
Danish: • Ved kreatininclearance mellem 20 og 50 ml/min bør initialdosis af Sifrol fordeles på 2 daglige doser begyndende med 0,088 mg base (0,125 mg salt) to gange dagligt svarende til 0,176 mg base (0,25 mg salt)/dag.
English: 1 tablet SIFROL 0.35 mg and 1 tablet SIFROL 0.18 mg
Danish: 1 SIFROL tablet á 0,35 mg og 1SIFROL tablet á 0,18 mg
English: If you are switching from SIFROL (immediate release) tablets Your doctor will base your dose of SIFROL prolonged-release tablets on the dose of SIFROL (immediate release) tablets you were taking.
Danish: Din læge vil basere din dosis af SIFROL depottabletter på den dosis af almindelige SIFROL tabletter, som du hidtil har taget.
English: Ascending dose schedule of SIFROL prolonged-release tablets Week Daily dose (mg of base)
Danish: Skema til øgning af dosis for Sifrol Titreringstrin 1 gang daglig Aften dosis (mg af base)
English: 1 tablet SIFROL 0.7 mg and 1 tablet SIFROL 0.35 mg three times a day
Danish: 1 SIFROL tablet á 0,7 mg og 1 SIFROL tablet á 0,35 mg 3 gange om dagen
English: If you have moderate kidney disease, the usual starting dose is 1 tablet SIFROL 0.088 mg twice a day.
Danish: Hvis din nyresygdom er moderat, er startdosis oftest 1 SIFROL tablet á 0,088 mg 2 gange daglig.
English: SIFROL can be taken with or without food.
Danish: SIFROL kan enten tages sammen med mad eller alene.
English: SIFROL is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on off” fluctuations).
Danish: Sifrol kan gives, som monoterapi eller i kombination med levodopa i hele sygdomsforløbet herunder i de sene stadier, når virkningen af levodopa klinger af eller bliver ustabil, og svingninger i den terapeutiske virkning opstår.
English: SIFROL 0.7 mg tablets are white, of round shape, and flat.
Danish: SIFROL 0,7 mg er hvide, runde og flade tabletter.
English: Psychiatric disorders insomnia abnormal dreams restlessness confusion hallucinations libido disorder delusion hyperphagia paranoia mania delirium behavioural symptoms of impulse control disorders and compulsions (such as: compulsive shopping, pathological gambling, hypersexuality, binge eating)
Danish: rastløshed, konfusion, hallucinationer, ændring af libido, vrangsforestillinger hyperfagi paranoia mani delirium usædvanlig adfærd med symptomer på manglende impulskontrol og tvangshandlinger (såsom overdrevent indkøbsmønster, ludomani, hyperseksualitet, uhæmmet fødeindtagelse)
English: If you accidentally take too many tablets, - Contact your doctor or nearest hospital casualty department immediately for advice.
Danish: Hvis du har taget for mange SIFROL tabletter Hvis du har taget for mange SIFROL tabletter, så kontakt lægen eller skadestuen med det samme.
English: How to take SIFROL
Danish: Sådan skal du tage SIFROL
English: In patients with a creatinine clearance less than 20 ml/min, the daily dose of SIFROL should be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily.
Danish: • Ved kreatininclearance mindre end 20 ml/min bør Sifrol gives som en enkeltdosis begyndende med 0,088 mg base (0,125 mg salt) per døgn.
English: In advanced Parkinson's disease, in combination treatment with levodopa, dyskinesia can occur during the initial titration of SIFROL.
Danish: Ved fremskreden Parkinsons sygdom kan dyskinesi forekomme i optitreringsfasen med Sifrol, når det gives i kombination med levodopa.
English: If renal function declines during maintenance therapy the SIFROL daily dose should be reduced by the same percentage as the decline in creatinine clearance, i.e. if creatinine clearance declines by 30%, then the SIFROL daily dose should be reduced by 30%.
Danish: Dvs. hvis f.eks. kreatininclearance reduceres med 30%, så reduceres den daglige dosis tilsvarende med 30%.
English: - treat the symptoms of moderate to severe primary Restless Legs Syndrome in adults.
Danish: • behandling af voksne patienter med symptomer på moderat til svær restless legs syndrom (RLS), en sygdom, der giver uro i benene.
English: SIFROL is used to treat the symptoms of primary Parkinson's disease in adults.
Danish: SIFROL bruges til behandling af voksne patienter med symptomer på Parkinsons sygdom.
English: SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets
Danish: Sifrol 0,088 mg tabletter Sifrol 0,18 mg tabletter Sifrol 0,35 mg tabletter Sifrol 0,7 mg tabletter
English: You should avoid taking SIFROL together with antipsychotic medicines.
Danish: Medicin mod psykiske lidelser (antipsykotika) må ikke tages sammen med SIFROL.
English: It is recommended that the dose of levodopa is reduced during both the dose escalation and the maintenance treatment with SIFROL, depending on reactions in individual patients (see section 4.5).
Danish: Afhængigt af den enkelte patients respons på behandlingen kan det anbefales, at levodopadosis reduceres både under dosisstigning og vedligeholdelsesbehandling med Sifrol (se pkt.