FrancophonIA/ELRC3.0 huggingface dataset:
English: If use of SIFROL is unavoidable, breast-feeding should be stopped.
Danish: Hvis du ikke kan undvære SIFROL, bør amningen stoppe.
English: After switching to SIFROL prolonged-release tablets, the dose may be adjusted depending on the patient's therapeutic response (see section 5.1).
Danish: Afhængigt af patientens terapeutiske respons kan dosis af Sifrol depottabletter justeres efterfølgende (se pkt.
English: Uncommon: - Urge to behave in an unusual way* - Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)* - Inappropriate antidiuretic hormone secretion*
Danish: • Hjertesvigt (hjerteproblemer, der kan forårsage åndenød eller hævede ankler)*
English: SIFROL 0.088 mg tablets
Danish: Sifrol 0,088 mg tabletter
English: The once daily administration of SIFROL prolonged-release tablets causes less frequent fluctuations in the pramipexole plasma concentration over 24 hours compared to the three times daily administration of pramipexole immediate release tablets.
Danish: Der er set færre svingninger i plasmakoncentrationen for pramipexol i løbet af 24 timer for Sifrol depottabletter givet en gang daglig end for Sifrol tabletter givet 3 gange daglig.
English: SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets Pramipexole
Danish: SIFROL 0,088 mg tabletter SIFROL 0,18 mg tabletter SIFROL 0,35 mg tabletter SIFROL 0,7 mg tabletter pramipexol
English: SIFROL 0.35 mg tablets
Danish: Sifrol 0,35 mg tabletter
English: Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following: - Kidney disease.
Danish: Fortæl det til din læge, hvis du har eller har haft nogen af nedenstående sygdomme eller tilstande:
English: What SIFROL looks like and contents of the pack SIFROL 0.26 mg and 0.52 mg prolonged-release tablets are white to off-white, of round shape, and have bevelled edges.
Danish: SIFROL 0,26 mg og 0,52 mg depottabletter er hvide til råhvide, runde og har facetslebne kanter.
English: - Vision impairment.
Danish: • Synsnedsættelse.
English: SIFROL 0.26 mg prolonged-release tablets SIFROL 0.52 mg prolonged-release tablets SIFROL 1.05 mg prolonged-release tablets SIFROL 1.57 mg prolonged-release tablets SIFROL 2.1 mg prolonged-release tablets SIFROL 2.62 mg prolonged-release tablets SIFROL 3.15 mg prolonged-release tablets
Danish: SIFROL 0,26 mg depottabletter SIFROL 0,52 mg depottabletter SIFROL 1,05 mg depottabletter SIFROL 1,57 mg depottabletter SIFROL 2,1 mg depottabletter SIFROL 2,62 mg depottabletter SIFROL 3,15 mg depottabletter pramipexol
English: SIFROL 0.35 mg tablets EU/1/97/050/011-012
Danish: Sifrol 0,35 mg tabletter EU/1/97/050/011-012
English: SIFROL 0.7 mg tablets
Danish: Sifrol 0,7 mg tabletter
English: INFORMATION IN BRAILLE SIFROL 0.088 mg
Danish: INFORMATION I BRAILLESKRIFT SIFROL 0,088 mg
English: In a Phase I trial, where pramipexole immediate release and prolonged-release tablets were assessed in fasted state, the minimum and peak plasma concentration (Cmin, Cmax) and exposure (AUC) of the same daily dose of SIFROL prolonged-release tablets given once daily and SIFROL tablets given three times a day were equivalent.
Danish: Et fase-I studie, hvor pramipexoltabletter blev sammenlignet med pramipexoldepottabletter, viste ækvivalens mellem den samme døgndosis af Sifrol depottabletter givet en gang daglig og Sifrol tabletter givet 3 gange daglig for Cmin, Cmax og AUC.
English: SIFROL 0.7 mg tablets EU/1/97/050/005-006
Danish: Sifrol 0,7 mg tabletter EU/1/97/050/005-006
English: SIFROL has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson's disease.
Danish: Bivirkninger som søvnighed og pludselig indsættende søvn er set specielt for Parkinsonpatienter.
English: Pneumonia
Danish: • feber
English: SIFROL 0.088 mg tablets EU/1/97/050/001-002
Danish: Sifrol 0,088 mg tabletter EU/1/97/050/001-002
English: Children and adolescents SIFROL is not recommended for use in children or adolescents under 18 years.
Danish: Børn og unge Børn og unge under 18 år bør ikke bruge SIFROL.
English: SIFROL 0.18 mg tablets
Danish: Sifrol 0,18 mg tabletter
English: 2 tablets SIFROL 0.18 mg three times a day
Danish: 2 SIFROL tabletter á 0,18 mg 3 gange om dagen
English: In severe kidney disease, the usual starting dose is just 1 tablet SIFROL 0.088 mg a day.
Danish: Hvis din nyresygdom er alvorlig, er startdosis oftest 1 SIFROL tablet á 0,088 mg 1 gang daglig.
English: 1 tablet SIFROL 0.35 mg OR
Danish: 1 SIFROL tablet á 0,35 mg
English: SIFROL can cause hallucinations (seeing, hearing or feeling things that are not there).
Danish: • Hallucinationer (ser, hører eller føler ting, som ikke er der).
English: SIFROL 0.18 mg tablets EU/1/97/050/003-004
Danish: Sifrol 0,18 mg tabletter EU/1/97/050/003-004
English: Since the daily dose for the treatment of Restless Legs Syndrome will not exceed 0.54 mg of base (0.75 mg of salt) SIFROL can be discontinued without tapering off.
Danish: Sifrol kan ved behandling af restless legs syndrom (RLS) seponeres uden aftrapning, idet den daglige dosis ikke vil overstige 0,54 mg base (0,75 mg salt).
English: INFORMATION IN BRAILLE SIFROL 0.35 mg
Danish: INFORMATION I BRAILLESKRIFT SIFROL 0,35 mg
English: 1 tablet SIFROL 0.35 mg three times a day OR
Danish: 1 SIFROL tablet á 0,35 mg 3 gange om dagen
English: 2 tablets SIFROL 0.088 mg three times a day
Danish: 2 SIFROL tabletter á 0,088 mg 3 gange om dagen
English: INFORMATION IN BRAILLE SIFROL 0.18 mg
Danish: INFORMATION I BRAILLESKRIFT SIFROL 0,18 mg
English: INFORMATION IN BRAILLE SIFROL 0.7 mg
Danish: INFORMATION I BRAILLESKRIFT SIFROL 0,7 mg
English: SIFROL 2.62 mg prolonged-release tablets
Danish: Sifrol 2,62 mg depottabletter
English: 1 tablet SIFROL 0.088 mg three times a day
Danish: 1 SIFROL tablet á 0,088 mg 3 gange om dagen
English: Take SIFROL prolonged-release tablets only once a day and each day at about the same time.
Danish: SIFROL depottabletter skal tages en gang daglig.
English: OR four SIFROL 0.26 mg prolonged-release tablets.
Danish: 4 SIFROL 0,26 mg depottabletter.
English: If you suffer from Parkinson's disease you should not stop treatment with SIFROL abruptly.
Danish: Hvis du har Parkinsons sygdom, bør du ikke stoppe behandlingen med SIFROL pludseligt, da det kan medføre en sygelig tilstand, der udgør en alvorlig helbredsrisiko (malignt neuroleptika syndrom).
English: 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 (CGI-I and PGI-I responder rates) efficacy endpoints in a double-blind placebo-controlled trial including a total of 539 patients with early Parkinson's disease.
Danish: Et dobbeltblindet, placebokontrolleret studie med 539 patienter med tidlig Parkinsons sygdom viste, at Sifrol depottabletter havde en bedre virkning (superior) end placebo efter 18 ugers behandling på både det primære (UPDRS del II+III score) og vigtigste sekundære (CGI-I og PGI-I responderhastigheder) endepunkter.
English: INFORMATION IN BRAILLE SIFROL 2.62 mg prolonged-release tablets 17.
Danish: INFORMATION I BRAILLESKRIFT SIFROL 2,62 mg depottabletter
English: Vascular disorders
Danish: Depottabletter
English: 1 tablet SIFROL 0.18 mg three times a day OR
Danish: 1 SIFROL tablet á 0,18 mg 3 gange om dagen
English: SIFROL 1.05 mg prolonged-release tablets
Danish: Sifrol 1,05 mg depottabletter
English: SIFROL 2.1 mg prolonged-release tablets
Danish: Sifrol 2,1 mg depottabletter
English: 1 tablet SIFROL 0.18 mg OR
Danish: 1 SIFROL tablet á 0,18 mg
English: NAME OF THE MEDICINAL PRODUCT SIFROL 0.088 mg tablets Pramipexole
Danish: LÆGEMIDLETS NAVN SIFROL 0,088 mg tabletter pramipexol
English: NAME OF THE MEDICINAL PRODUCT SIFROL 2.62 mg prolonged-release tablets Pramipexole
Danish: LÆGEMIDLETS NAVN SIFROL 2,62 mg depottabletter pramipexol
English: SIFROL 3.15 mg prolonged-release tablets
Danish: Sifrol 3,15 mg depottabletter
English: INFORMATION IN BRAILLE SIFROL 1.57 mg prolonged-release tablets 17.
Danish: INFORMATION I BRAILLESKRIFT SIFROL 1,57 mg depottabletter
English: 2 tablets SIFROL 0.088 mg
Danish: 2 SIFROL tabletter á 0,088 mg
English: NAME OF THE MEDICINAL PRODUCT SIFROL 0.35 mg tablets Pramipexole
Danish: LÆGEMIDLETS NAVN SIFROL 0,35 mg tabletter pramipexol
English: 4 tablets SIFROL 0.088 mg
Danish: 4 SIFROL tabletter á 0,088 mg
English: 3 tablets SIFROL 0.18 mg OR
Danish: 3 SIFROL tabletter á 0,18 mg
English: INFORMATION IN BRAILLE SIFROL 2.1 mg prolonged-release tablets 17.
Danish: INFORMATION I BRAILLESKRIFT SIFROL 2,1 mg depottabletter
English: SIFROL 1.57 mg prolonged-release tablets
Danish: Sifrol 1,57 mg depottabletter
English: INFORMATION IN BRAILLE SIFROL 3.15 mg prolonged-release tablets 17.
Danish: INFORMATION I BRAILLESKRIFT SIFROL 3,15 mg depottabletter
English: 2 tablets SIFROL 0.18 mg OR
Danish: 2 SIFROL tabletter á 0,18 mg
English: If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start treatment with SIFROL.
Danish: Dosis bør nedsættes, når du starter behandling med SIFROL.
English: NAME OF THE MEDICINAL PRODUCT SIFROL 0.7 mg tablets Pramipexole
Danish: LÆGEMIDLETS NAVN SIFROL 0,7 mg tabletter pramipexol
English: INFORMATION IN BRAILLE SIFROL 1.05 mg prolonged-release tablets 17.
Danish: INFORMATION I BRAILLESKRIFT SIFROL 1,05 mg depottabletter
English: 6 tablets SIFROL 0.088 mg
Danish: 6 SIFROL tabletter á 0,088 mg
English: SIFROL 0.52 mg prolonged-release tablets
Danish: Sifrol 0,52 mg depottabletter
English: NAME OF THE MEDICINAL PRODUCT SIFROL 1.57 mg prolonged-release tablets Pramipexole
Danish: LÆGEMIDLETS NAVN SIFROL 1,57 mg depottabletter pramipexol
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/016 [10 prolonged-release tablets] EU/1/97/050/017 [30 prolonged-release tablets] EU/1/97/050/018 [100 prolonged-release tablets]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/050/016 [SIFROL, 10 depottabletter] EU/1/97/050/017 [SIFROL, 30 depottabletter] EU/1/97/050/018 [SIFROL, 100 depottabletter]
English: NAME OF THE MEDICINAL PRODUCT SIFROL 0.18 mg tablets Pramipexole
Danish: LÆGEMIDLETS NAVN SIFROL 0,18 mg tabletter pramipexol
English: If you have advanced Parkinson's disease and are also taking levodopa, you might develop dyskinesia during the uptitration of SIFROL.
Danish: • Ufrivillige bevægelser af arme og ben (dyskinesi) Hvis du har Parkinsons sygdom i fremskreden grad og samtidig behandles med levodopa, kan der være risiko for udvikling af ufrivillige bevægelser (dyskinesi), når SIFROL-dosis øges
English: NAME OF THE MEDICINAL PRODUCT SIFROL 3.15 mg prolonged-release tablets Pramipexole
Danish: LÆGEMIDLETS NAVN SIFROL 3,15 mg depottabletter pramipexol
English: What SIFROL is and what it is used for What you need to know before you take SIFROL How to take SIFROL
Danish: Det skal du vide, før du begynder at tage SIFROL Sådan skal du tage SIFROL Bivirkninger
English: NAME OF THE MEDICINAL PRODUCT SIFROL 1.05 mg prolonged-release tablets Pramipexole
Danish: LÆGEMIDLETS NAVN SIFROL 1,05 mg depottabletter pramipexol
English: Ascending dose schedule of SIFROL prolonged-release tablets Week Daily dose (mg) Number of tablets One SIFROL 0.26 mg prolonged-release tablet.
Danish: Skema for øgning af dosis for Sifrol depottabletter Uge Døgndosis (mg base) Døgndosis (mg salt)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/025 [10 prolonged-release tablets] EU/1/97/050/026 [30 prolonged-release tablets] EU/1/97/050/027 [100 prolonged-release tablets]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/050/025 [SIFROL, 10 depottabletter] EU/1/97/050/026 [SIFROL, 30 depottabletter] EU/1/97/050/027 [SIFROL, 100 depottabletter]
English: The tablets are white, flat, of oval shape, scored on both sides, and have a code embossed (one side with the code P8, and one side with the Boehringer Ingelheim company symbol).
Danish: Tabletterne er hvide, flade, ovale med delekærv på begge sider og er præget med en kode på begge sider (P8 hhv. Boehringer Ingelheim logo).
English: NAME OF THE MEDICINAL PRODUCT SIFROL 2.1 mg prolonged-release tablets Pramipexole
Danish: LÆGEMIDLETS NAVN SIFROL 2,1 mg depottabletter pramipexol
English: SIFROL 0.26 mg prolonged-release tablets
Danish: Sifrol 0,26 mg depottabletter
English: During the first week, the usual dose is 1 tablet SIFROL 0.088 mg once a day (equivalent to 0.088 mg daily):
Danish: I den første uge er dosis oftest 1 SIFROL tablet á 0,088 mg én gang daglig.
English: EU/1/97/050/002 [100 tablets]
Danish: EU/1/97/050/028-030
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/031 [10 prolonged-release tablets] EU/1/97/050/032 [30 prolonged-release tablets] EU/1/97/050/033 [100 prolonged-release tablets]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/050/031 [SIFROL, 10 depottabletter] EU/1/97/050/032 [SIFROL, 30 depottabletter] EU/1/97/050/033 [SIFROL, 100 depottabletter]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/013 [10 prolonged-release tablets] EU/1/97/050/014 [30 prolonged-release tablets] EU/1/97/050/015 [100 prolonged-release tablets]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/050/013 [SIFROL, 10 depottabletter] EU/1/97/050/014 [SIFROL, 30 depottabletter] EU/1/97/050/015 [SIFROL, 100 depottabletter]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/028 [10 prolonged-release tablets] EU/1/97/050/029 [30 prolonged-release tablets] EU/1/97/050/030 [100 prolonged-release tablets]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/050/028 [SIFROL, 10 depottabletter] EU/1/97/050/029 [SIFROL, 30 depottabletter] EU/1/97/050/030 [SIFROL, 100 depottabletter]
English: What SIFROL looks like and contents of the pack SIFROL 0.088 mg tablets are white, of round shape, flat, and without scoring.
Danish: SIFROL 0,088 mg er hvide, runde, flade tabletter og er uden delekærv.
English: INFORMATION IN BRAILLE SIFROL 0.26 mg prolonged-release tablets 17.
Danish: INFORMATION I BRAILLESKRIFT SIFROL 0,26 mg depottabletter
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/022 [10 prolonged-release tablets] EU/1/97/050/023 [30 prolonged-release tablets] EU/1/97/050/024 [100 prolonged-release tablets]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/050/022 [SIFROL, 10 depottabletter] EU/1/97/050/023 [SIFROL, 30 depottabletter] EU/1/97/050/024 [SIFROL, 100 depottabletter]
English: When prescribing SIFROL in a patient with Parkinson's disease with renal impairment a reduced dose is suggested in line with section 4.2.
Danish: Hos patienter med Parkinsons sygdom og nedsat nyrefunktion bør dosis reduceres, se pkt.
English: You should have regular eye examinations during treatment with SIFROL.
Danish: Så længe du er i behandling med SIFROL, anbefales det at få øjnene undersøgt regelmæssigt
English: INFORMATION IN BRAILLE SIFROL 0.52 mg prolonged-release tablets 17.
Danish: INFORMATION I BRAILLESKRIFT SIFROL 0,52 mg depottabletter
English: Each prolonged-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.26 mg pramipexole.
Danish: Hver depottablet indeholder 0,375 mg pramipexol dihydrochloridmonohydrat svarende til 0,26 mg pramipexol.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/019 [10 prolonged-release tablets] EU/1/97/050/020 [30 prolonged-release tablets] EU/1/97/050/021 [100 prolonged-release tablets]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/050/019 [SIFROL, 10 depottabletter] EU/1/97/050/020 [SIFROL, 30 depottabletter] EU/1/97/050/021 [SIFROL, 100 depottabletter]
English: NAME OF THE MEDICINAL PRODUCT SIFROL 0.52 mg prolonged-release tablets Pramipexole
Danish: LÆGEMIDLETS NAVN SIFROL 0,52 mg depottabletter pramipexol
English: Uncommon may affect up to 1 in 100 people
Danish: Kan forekomme hos mellem 1 og 10 ud af 100 patienter Ikke almindelig Kan forekomme hos mellem 1 og 10 ud af 1000 patienter Sjælden
English: NAME OF THE MEDICINAL PRODUCT SIFROL 0.26 mg prolonged-release tablets Pramipexole
Danish: LÆGEMIDLETS NAVN SIFROL 0,26 mg depottabletter pramipexol
English: EU/1/97/050/004 [100 tablets]
Danish: EU/1/97/050/013-015
English: In these cases SIFROL may affect your ability to drive and operate machinery.
Danish: Hvis du tager beroligende medicin eller drikker alkohol, kan SIFROL påvirke din evne til at køre bil og håndtere maskiner.
English: The full EPAR for Rivastigmine Hexal can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Rivastigmine Hexal findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Rivastigmine Hexal should be given twice a day, with morning and evening meals.
Danish: Rivastigmine Hexal skal gives to gange dagligt, sammen med morgen- og aftensmåltidet.
English: It is available as capsules (1.5 mg, 3 mg, 4.5 mg and 6 mg) and as an oral solution (2 mg/ml).
Danish: Det leveres som kapsler (1,5 mg, 3 mg, 4,5 mg og 6 mg) og som oral opløsning (2 mg/ml).
English: This is a summary of the European public assessment report (EPAR) for Rivastigmine Hexal.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rivastigmin Hexal.
English: This authorisation was based on the authorisation granted to Exelon in 1998 (‘informed consent').
Danish: Denne tilladelse byggede på den tilladelse, som blev udstedt for Rivastigmine Hexal i 1998 (‘informeret samtykke').
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rivastigmine Hexal on 11 December 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rivastigmin 1 A Pharmaden 11. december 2009.
English: However, following a re-examination of this opinion, the Committee concluded that the medicine's modest effectiveness could also be of benefit to some of these patients.
Danish: Efter fornyet overvejelse af denne opfattelse konkluderede udvalget imidlertid, at lægemidlets beskedne virkning kan være en fordel for nogle af patienterne.
English: The main measures of effectiveness were the change in symptoms in two main areas: cognitive (the ability to think, learn and remember) and global (a combination of several areas including general function, cognitive symptoms, behaviour and the ability to carry out everyday activities).
Danish: Det primære effektmål var ændringen i symptomer på to hovedområder: Dels kognitive funktioner (evnen til at tænke, lære og huske), dels overordnede funktioner (en kombination af flere områder bestående af generel funktionsevne, kognitive symptomer, adfærd og evne til at udføre daglige aktiviteter).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Rivastigmine Hexal.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Rivastigmin Hexal.
English: Other information about Rivastigmine Hexal
Danish: Andre oplysninger om Rivastigmine Hexal
English: It must also not be used in patients who are suspected to have had in the past an allergic reaction called ‘allergic contact dermatitis' to Exelon patch.
Danish: Det må heller ikke anvendes til patienter, hvor der er mistanke om, at der tidligere er forekommet en svær allergisk reaktion kaldet ‘allergisk kontaktdermatit' over for Exelon-depotplaster.
English: An additional study in 27 patients was used to show that Rivastigmine Hexal capsules and oral solution produced similar levels of the active substance in the blood.
Danish: I endnu en undersøgelse hos 27 patienter blev det vist, at Rivastigmine Hexal-kapsler og oral opløsning giver samme indhold af aktivt stof i blodet.
English: For more information about treatment with Rivastigmine Hexal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Rivastigmine Hexal, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a chemical that allows nerve cells to communicate with each other).
Danish: Hos patienter med Alzheimers sygdom eller med demens som følge af Parkinsons sygdom vil visse hjerneceller dø, hvilket medfører et for lavt indhold af neurotransmitteren acetylcholin (et kemisk stof, som bevirker, at nervecellerne kan kommunikere indbyrdes).
English: Treatment with Rivastigmine Hexal should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease or dementia in patients with Parkinson's disease.
Danish: Behandlingen med Rivastigmine Hexal bør indledes og overvåges af en læge med erfaring i diagnosticering og behandling af Alzheimers sygdom eller demens hos patienter med Parkinsons sygdom.
English: Rivastigmine Hexal was more effective than placebo at controlling symptoms.
Danish: Rivastigmine Hexal var mere effektivt end placebo til at begrænse symptomerne.
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Rivastigmine Hexal by the patient.
Danish: Behandling bør kun indledes, hvis patienten har en plejer, der regelmæssigt overvåger patientens indtagelse af Rivastigmine Hexal.
English: Overall, the most common side effects include nausea (feeling sick, seen in 38 patients in 100) and vomiting (seen in 23 patients in 100), particularly during the phase when the dose of Rivastigmine Hexal is being increased.
Danish: Som helhed er de mest almindelige bivirkninger kvalme (som optræder hos 38 ud af 100 patienter) og opkastning (som optræder hos 23 ud af 100 patienter), især i den fase, hvor Rivastigmine Hexal-dosen øges.
English: Therefore, the Committee decided that Rivastigmine Hexal's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget var derfor af den opfattelse, at fordelene ved Rivastigmine Hexal opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Rivastigmine Hexal is a medicine containing the active substance rivastigmine.
Danish: Rivastigmin Hexal er et lægemiddel, der indeholder det aktive stof rivastigmin.
English: Rivastigmine Hexal is used for the treatment of patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Danish: Rivastigmine Hexal anvendes til behandling af patienter med let til middelsvær Alzheimers sygdom, en fremadskridende hjernesygdom, der gradvis angriber hukommelse, intellektuelle evner og adfærd.
English: Rivastigmine Hexal was also studied in 541 patients with dementia due to Parkinson's disease.
Danish: Rivastigmine Hexal blev desuden undersøgt hos 541 patienter med demens som følge af Parkinsons sygdom.
English: Rivastigmine Hexal has been studied in three main studies involving 2,126 patients with mild to moderately severe Alzheimer's disease.
Danish: Rivastigmine Hexal blev undersøgt i tre hovedundersøgelser med 2 126 patienter med let til middelsvær Alzheimers sygdom.
English: In patients who tolerate this dose, it can be increased in 1.5-mg steps no more frequently than every two weeks, to a regular dose of 3 to 6 mg twice a day.
Danish: Hos patienter, der tåler denne dosis, kan dosis øges i trin på 1,5 mg med mindst to uger mellem hvert trin, indtil en fast dosis på 3 til 6 mg to gange dagligt er nået.
English: For the full list of all side effects reported with Rivastigmine Hexal, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Rivastigmine Hexal fremgår af indlægssedlen.