FrancophonIA/ELRC3.0 huggingface dataset:
English: MIRAPEXIN 0.088 mg tablets MIRAPEXIN 0.18 mg tablets MIRAPEXIN 0.35 mg tablets MIRAPEXIN 0.7 mg tablets Pramipexole
Danish: MIRAPEXIN 0,088 mg tabletter MIRAPEXIN 0,18 mg tabletter MIRAPEXIN 0,35 mg tabletter MIRAPEXIN 0,7 mg tabletter pramipexol
English: If use of MIRAPEXIN is unavoidable, breast-feeding should be stopped.
Danish: Hvis du ikke kan undvære MIRAPEXIN, bør amningen stoppe.
English: One MIRAPEXIN 1.05 mg prolonged-release tablet, OR
Danish: 1 MIRAPEXIN 1,05 mg depottablet, ELLER
English: - You may experience vomiting, restlessness, or any of the side effects as described in section 4
Danish: Tegn på overdosering kan blandt andet være opkastning, rastløshed eller nogle af de andre bivirkninger, der er anført under pkt.
English: The once daily administration of MIRAPEXIN 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 Mirapexin depottabletter givet en gang daglig end for Mirapexin tabletter givet 3 gange daglig.
English: What MIRAPEXIN looks like and contents of the pack MIRAPEXIN 0.26 mg and 0.52 mg prolonged-release tablets are white to off-white, of round shape, and have bevelled edges.
Danish: MIRAPEXIN 0,26 mg og 0,52 mg depottabletter er hvide til råhvide, runde og har facetslebne kanter.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det til din læge, hvis du har eller har haft nogen af nedenstående sygdomme eller tilstande:
English: You should avoid taking MIRAPEXIN together with antipsychotic medicines.
Danish: Medicin mod psykiske lidelser (antipsykotika) må ikke tages sammen med MIRAPEXIN.
English: Common: - Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness - Tiredness (fatigue) - Headache - Abnormal dreams - Constipation - Dizziness - Vomiting (being sick)
Danish: • Forandring af søvnmønster, såsom søvnløshed (insomni) og søvnighed
English: MIRAPEXIN 2.62 mg prolonged-release tablets EU/1/97/051/031-033
Danish: Mirapexin 2,62 mg depottabletter EU/1/97/051/031-033
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 MIRAPEXIN prolonged-release tablets given once daily and MIRAPEXIN 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 Mirapexin depottabletter givet en gang daglig og Mirapexin tabletter givet 3 gange daglig for Cmin, Cmax og AUC.
English: In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson's disease.
Danish: Klinisk virkning og sikkerhed ved Parkinsons sygdom Hos patienter reducerer pramipexol tegn og symptomer på idiopatisk Parkinsons sygdom.
English: After switching to MIRAPEXIN 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 Mirapexin depottabletter justeres efterfølgende (se pkt.
English: In severe kidney disease, the usual starting dose is just 1 tablet MIRAPEXIN 0.088 mg a day.
Danish: Hvis din nyresygdom er alvorlig, er startdosis oftest 1 MIRAPEXIN tablet á 0,088 mg 1 gang daglig.
English: 1 tablet MIRAPEXIN 0.35 mg
Danish: 1 MIRAPEXIN tablet á 0,35 mg
English: If renal function declines during maintenance therapy the MIRAPEXIN 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 MIRAPEXIN daily dose should be reduced by 30%.
Danish: • Hvis nyrefunktionen bliver nedsat under vedligeholdelsesbehandling med Mirapexin, bør dosis reduceres med samme procent, som faldet i kreatininclearance.
English: MIRAPEXIN 0.35 mg tablets EU/1/97/051/011-012
Danish: Mirapexin 0,35 mg tabletter EU/1/97/051/011-012
English: Very rare may affect up to 1 in 10,000 people
Danish: Kan forekomme hos mellem 1 og 10 ud af 10.000 patienter Meget sjælden Kan forekomme hos færre end 1 ud af 10.000 patienter Ikke kendt
English: 2 tablets MIRAPEXIN 0.088 mg three times a day
Danish: 2 MIRAPEXIN tabletter á 0,088 mg 3 gange om dagen
English: MIRAPEXIN 0.088 mg tablets EU/1/97/051/001-002
Danish: Mirapexin 0,088 mg tabletter EU/1/97/051/001-002
English: MIRAPEXIN 0.088 mg tablets
Danish: Mirapexin 0,088 mg tabletter
English: Dose Schedule of MIRAPEXIN Titration Step Once Daily Evening Dose
Danish: Skema til øgning af dosis for Mirapexin Titreringstrin 1 gang daglig Aften dosis (mg af base)
English: MIRAPEXIN 0.7 mg tablets EU/1/97/051/005-006
Danish: Mirapexin 0,7 mg tabletter EU/1/97/051/005-006
English: MIRAPEXIN 0.35 mg tablets
Danish: Mirapexin 0,35 mg tabletter
English: (mg of base)
Danish: (mg af salt)
English: Thereafter the dose should be reduced by 0.264 mg of base (0.375 mg of salt) per day (see section 4.4).
Danish: Derefter bør dosis reduceres med 0,264 mg base (0,375 mg salt)/dag (se pkt.
English: MIRAPEXIN 2.62 mg prolonged-release tablets
Danish: Mirapexin 2,62 mg depottabletter
English: Take MIRAPEXIN prolonged-release tablets only once a day and each day at about the same time.
Danish: MIRAPEXIN depottabletter skal tages en gang daglig.
English: INFORMATION IN BRAILLE MIRAPEXIN 2.62 mg prolonged-release tablets
Danish: INFORMATION I BRAILLESKRIFT MIRAPEXIN 2,62 mg depottabletter
English: MIRAPEXIN 0.18 mg tablets EU/1/97/051/003-004
Danish: Mirapexin 0,18 mg tabletter EU/1/97/051/003-004
English: PHARMACEUTICAL FORM AND CONTENTS 10 prolonged-release tablets 30 prolonged-release tablets 100 prolonged-release tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 10 depottabletter
English: 2 tablets MIRAPEXIN 0.18 mg three times a day
Danish: 2 MIRAPEXIN tabletter á 0,18 mg 3 gange om dagen
English: MIRAPEXIN 0.52 mg prolonged-release tablets EU/1/97/051/016-018
Danish: Mirapexin 0,52 mg depottabletter EU/1/97/051/016-018
English: Take care if you are taking the following medicines: - cimetidine (to treat excess stomach acid and stomach ulcers) - amantadine (which can be used to treat Parkinson's disease) - mexiletine (to treat irregular heartbeats, a condition known as ventricular arrhythmia) - zidovudine (which can be used to treat the acquired immune deficiency syndrome (AIDS), a disease of the human immune system) - cisplatin (to treat various types of cancers) - quinine (which can be used for the prevention of painful night-time leg cramps and for the treatment of a type of malaria known as falciparum malaria (malignant malaria)) - procainamide (to treat irregular heart beat)
Danish: • quinin (medicin til forebyggelse af smertefulde natlige lægkramper og til behandling af en malariatype kendt som falciparum malaria (ondartet malaria))
English: Children and adolescents MIRAPEXIN 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 MIRAPEXIN.
English: Thereafter the dose should be reduced by 0.26 mg of base (0.375 mg of salt) per day (see section 4.4).
Danish: Derefter bør dosis reduceres med 0,26 mg base (0,375 mg salt)/dag (se pkt.
English: 1 tablet MIRAPEXIN 0.35 mg three times a day OR
Danish: 1 MIRAPEXIN tablet á 0,35 mg 3 gange om dagen
English: MIRAPEXIN 0.7 mg tablets
Danish: Mirapexin 0,7 mg tabletter
English: MIRAPEXIN 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: Since the daily dose for the treatment of Restless Legs Syndrome will not exceed 0.54 mg of base (0.75 mg of salt) MIRAPEXIN can be discontinued without tapering off.
Danish: Mirapexin 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 MIRAPEXIN 3.15 mg prolonged-release tablets
Danish: INFORMATION I BRAILLESKRIFT MIRAPEXIN 3,15 mg depottabletter
English: INFORMATION IN BRAILLE MIRAPEXIN 0.088 mg
Danish: INFORMATION I BRAILLESKRIFT MIRAPEXIN 0,088 mg
English: MIRAPEXIN 1.05 mg prolonged-release tablets
Danish: Mirapexin 1,05 mg depottabletter
English: MIRAPEXIN 3.15 mg prolonged-release tablets
Danish: Mirapexin 3,15 mg depottabletter
English: What MIRAPEXIN is and what it is used for What you need to know before you take MIRAPEXIN How to take MIRAPEXIN
Danish: Det skal du vide, før du begynder at tage MIRAPEXIN Sådan skal du tage MIRAPEXIN Bivirkninger
English: INFORMATION IN BRAILLE MIRAPEXIN 0.26 mg prolonged-release tablets
Danish: INFORMATION I BRAILLESKRIFT MIRAPEXIN 0,26 mg depottabletter
English: MIRAPEXIN 0.18 mg tablets
Danish: Mirapexin 0,18 mg tabletter
English: This is to avoid postural hypotension (a fall in blood pressure on standing up).
Danish: • Lavt blodtryk (hypotension)
English: You should have regular eye examinations during treatment with MIRAPEXIN.
Danish: Dosis bør nedsættes, når du starter behandling med MIRAPEXIN.
English: INFORMATION IN BRAILLE MIRAPEXIN 1.05 mg prolonged-release tablets
Danish: INFORMATION I BRAILLESKRIFT MIRAPEXIN 1,05 mg depottabletter
English: MIRAPEXIN 1.57 mg prolonged-release tablets
Danish: Mirapexin 1,57 mg depottabletter
English: MIRAPEXIN 1.05 mg prolonged-release tablets EU/1/97/051/019-021
Danish: Mirapexin 1,05 mg depottabletter EU/1/97/051/019-021
English: MIRAPEXIN 3.15 mg prolonged-release tablets EU/1/97/051/025-027
Danish: Mirapexin 3,15 mg depottabletter EU/1/97/051/025-027
English: EU/1/97/051/002 [100 tablets]
Danish: EU/1/97/051/022-024
English: MIRAPEXIN 0.26 mg prolonged-release tablets Each prolonged-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.26 mg pramipexole.
Danish: Mirapexin 0,7 mg tabletter Hver tablet indeholder 1,0 mg pramipexol dihydrochloridmonohydrat svarende til 0,7 mg pramipexol.
English: INFORMATION IN BRAILLE MIRAPEXIN 0.35 mg
Danish: INFORMATION I BRAILLESKRIFT MIRAPEXIN 0,35 mg
English: INFORMATION IN BRAILLE MIRAPEXIN 0.52 mg prolonged-release tablets
Danish: INFORMATION I BRAILLESKRIFT MIRAPEXIN 0,52 mg depottabletter
English: MIRAPEXIN 1.57 mg prolonged-release tablets EU/1/97/051/028-030
Danish: Mirapexin 1,57 mg depottabletter EU/1/97/051/028-030
English: INFORMATION IN BRAILLE MIRAPEXIN 1.57 mg prolonged-release tablets
Danish: INFORMATION I BRAILLESKRIFT MIRAPEXIN 1,57 mg depottabletter
English: Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg pramipexole.
Danish: Hver tablet indeholder 0,125 mg pramipexol dihydrochloridmonohydrat svarende til 0,088 mg pramipexol.
English: 1 tablet MIRAPEXIN 0.088 mg
Danish: 1 MIRAPEXIN tablet á 0,088 mg
English: 1 tablet MIRAPEXIN 0.18 mg
Danish: 1 MIRAPEXIN tablet á 0,18 mg
English: 3 tablets MIRAPEXIN 0.18 mg
Danish: 3 MIRAPEXIN tabletter á 0,18 mg
English: INFORMATION IN BRAILLE MIRAPEXIN 2.1 mg prolonged-release tablets
Danish: INFORMATION I BRAILLESKRIFT MIRAPEXIN 2,1 mg depottabletter
English: 1 tablet MIRAPEXIN 0.18 mg three times a day OR
Danish: 1 MIRAPEXIN tablet á 0,18 mg 3 gange om dagen
English: 2 tablets MIRAPEXIN 0.18 mg
Danish: 2 MIRAPEXIN tabletter á 0,18 mg
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 2.62 mg prolonged-release tablets Pramipexole
Danish: LÆGEMIDLETS NAVN MIRAPEXIN 2,62 mg depottabletter pramipexol
English: INFORMATION IN BRAILLE MIRAPEXIN 0.18 mg
Danish: INFORMATION I BRAILLESKRIFT MIRAPEXIN 0,18 mg
English: MIRAPEXIN 2.1 mg prolonged-release tablets
Danish: Mirapexin 2,1 mg depottabletter
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.088 mg tablets Pramipexole
Danish: LÆGEMIDLETS NAVN MIRAPEXIN 0,088 mg tabletter pramipexol
English: Colloidal anhydrous silica Magnesium stearate
Danish: 6.1 Hjælpestoffer mannitol majsstivelse kolloid vandfri silica povidon K 25 magnesiumstearat
English: Each prolonged-release tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.05 mg pramipexole.
Danish: Hver depottablet indeholder 1,5 mg pramipexol dihydrochloridmonohydrat svarende til 1,05 mg pramipexol.
English: If you suffer from Parkinson's disease you should not stop treatment with MIRAPEXIN abruptly.
Danish: Hvis du har Parkinsons sygdom, bør du ikke stoppe behandlingen med MIRAPEXIN pludseligt, da det kan medføre en sygelig tilstand, der udgør en alvorlig helbredsrisiko (malignt neuroleptika syndrom).
English: INFORMATION IN BRAILLE MIRAPEXIN 0.7 mg
Danish: INFORMATION I BRAILLESKRIFT MIRAPEXIN 0,7 mg
English: - Vomiting (being sick) - Weight loss including decreased appetite
Danish: • Vægttab samt nedsat appetit
English: MIRAPEXIN 0.52 mg prolonged-release tablets
Danish: Mirapexin 0,52 mg depottabletter
English: Each prolonged-release tablet contains 3 mg pramipexole dihydrochloride monohydrate equivalent to 2.1 mg pramipexole.
Danish: Hver depottablet indeholder 3 mg pramipexol dihydrochloridmonohydrat svarende til 2,1 mg pramipexol.
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.35 mg tablets Pramipexole
Danish: LÆGEMIDLETS NAVN MIRAPEXIN 0,35 mg tabletter pramipexol
English: Each prolonged-release tablet contains 3.75 mg pramipexole dihydrochloride monohydrate equivalent to 2.62 mg pramipexole.
Danish: Hver depottablet indeholder 3,75 mg pramipexol dihydrochloridmonohydrat svarende til 2,62 mg pramipexol.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg pramipexole.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En tablet indeholder 0,125 mg pramipexoldihydrochloridmonohydrat svarende til 0,088 mg pramipexol.
English: 4 tablets MIRAPEXIN 0.088 mg
Danish: 4 MIRAPEXIN tabletter á 0,088 mg
English: 2 tablets MIRAPEXIN 0.088 mg
Danish: 2 MIRAPEXIN tabletter á 0,088 mg
English: Doses should be increased gradually from a starting dose of 0.264 mg of base (0.375 mg of salt) per day and then increased every 5-7 days.
Danish: Dosis skal øges gradvist hver 5.-7. dag fra en startdosis på 0,264 mg base (0,375 mg salt)/døgn.
English: If you have advanced Parkinson's disease and are also taking levodopa, you might develop dyskinesia during the uptitration of MIRAPEXIN.
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 MIRAPEXIN-dosis øges
English: Each prolonged-release tablet contains 4.5 mg pramipexole dihydrochloride monohydrate equivalent to 3.15 mg pramipexole.
Danish: Hver depottablet indeholder 4,5 mg pramipexol dihydrochloridmonohydrat svarende til 3,15 mg pramipexol.
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.7 mg tablets Pramipexole
Danish: LÆGEMIDLETS NAVN MIRAPEXIN 0,7 mg tabletter pramipexol
English: Each prolonged-release tablet contains 2.25 mg pramipexole dihydrochloride monohydrate equivalent to 1.57 mg pramipexole.
Danish: Hver depottablet indeholder 2,25 mg pramipexol dihydrochloridmonohydrat svarende til 1,57 mg pramipexol.
English: 4.7 Effects on ability to drive and use machines MIRAPEXIN can have a major influence on the ability to drive and use machines.
Danish: Hvis du tager beroligende medicin eller drikker alkohol, kan MIRAPEXIN påvirke din evne til at køre bil og håndtere maskiner.
English: 6 tablets MIRAPEXIN 0.088 mg
Danish: 6 MIRAPEXIN tabletter á 0,088 mg
English: Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg pramipexole.
Danish: Hver tablet indeholder 0,5 mg pramipexol dihydrochloridmonohydrat svarende til 0,35 mg pramipexol.
English: Doses should be increased gradually from a starting dose of 0.26 mg of base (0.375 mg of salt) per day and then increased every 5-7 days.
Danish: Dosis skal øges gradvist hver 5.-7. dag fra en startdosis på 0,26 mg base (0,375 mg salt)/dag.
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 1.57 mg prolonged-release tablets Pramipexole
Danish: LÆGEMIDLETS NAVN MIRAPEXIN 1,57 mg depottabletter pramipexol
English: MIRAPEXIN 0.26 mg prolonged-release tablets
Danish: Mirapexin 0,26 mg depottabletter
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.18 mg tablets Pramipexole
Danish: LÆGEMIDLETS NAVN MIRAPEXIN 0,18 mg tabletter pramipexol
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 1.05 mg prolonged-release tablets Pramipexole
Danish: LÆGEMIDLETS NAVN MIRAPEXIN 1,05 mg depottabletter pramipexol
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/016 [10 prolonged-release tablets] EU/1/97/051/017 [30 prolonged-release tablets] EU/1/97/051/018 [100 prolonged-release tablets]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/051/016 [MIRAPEXIN, 10 depottabletter] EU/1/97/051/017 [MIRAPEXIN, 30 depottabletter] EU/1/97/051/018 [MIRAPEXIN, 100 depottabletter]
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 3.15 mg prolonged-release tablets Pramipexole
Danish: LÆGEMIDLETS NAVN MIRAPEXIN 3,15 mg depottabletter pramipexol
English: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg pramipexole.
Danish: Hver tablet indeholder 0,25 mg pramipexol dihydrochloridmonohydrat svarende til 0,18 mg pramipexol.
English: During the first week, the usual dose is 1 tablet MIRAPEXIN 0.088 mg once a day (equivalent to 0.088 mg daily):
Danish: I den første uge er dosis oftest 1 MIRAPEXIN tablet á 0,088 mg én gang daglig.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg pramipexole.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En tablet indeholder 1,0 mg pramipexoldihydrochloridmonohydrat svarende til 0,7 mg pramipexol.
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: 1, delirium usædvanlig adfærd med symptomer på manglende impulskontrol og tvangshandlinger (såsom overdrevent indkøbsmønster, ludomani, hyperseksualitet, uhæmmet fødeindtagelse)
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 2.1 mg prolonged-release tablets Pramipexole
Danish: LÆGEMIDLETS NAVN MIRAPEXIN 2,1 mg depottabletter pramipexol
English: Rare may affect up to 1 in 1,000 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: The tablets are white, flat, of round shape, scored on both sides, and have a code embossed (one side with the code P9, and one side with the Boehringer Ingelheim company symbol).
Danish: Tabletterne er hvide, flade, runde med delekærv på begge sider og er præget med en kode på begge sider (P9 hhv. Boehringer Ingelheim logo).
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: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg pramipexole.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En tablet indeholder 0,5 mg pramipexoldihydrochloridmonohydrat svarende til 0,35 mg pramipexol.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Danish: BILAG II A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg pramipexole.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En tablet indeholder 0,25 mg pramipexoldihydrochloridmonohydrat svarende til 0,18 mg pramipexol.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/025 [10 prolonged-release tablets] EU/1/97/051/026 [30 prolonged-release tablets] EU/1/97/051/027 [100 prolonged-release tablets]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/051/025 [MIRAPEXIN, 10 depottabletter] EU/1/97/051/026 [MIRAPEXIN, 30 depottabletter] EU/1/97/051/027 [MIRAPEXIN, 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 P7, 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 (P7 hhv. Boehringer Ingelheim logo).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/031 [10 prolonged-release tablets] EU/1/97/051/032 [30 prolonged-release tablets] EU/1/97/051/033 [100 prolonged-release tablets]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/051/031 [MIRAPEXIN, 10 depottabletter] EU/1/97/051/032 [MIRAPEXIN, 30 depottabletter] EU/1/97/051/033 [MIRAPEXIN, 100 depottabletter]
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.26 mg pramipexole.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En depottablet indeholder 0,375 mg pramipexoldihydrochloridmonohydrat svarende til 0,26 mg pramipexol.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/022 [10 prolonged-release tablets] EU/1/97/051/023 [30 prolonged-release tablets] EU/1/97/051/024 [100 prolonged-release tablets]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/051/022 [MIRAPEXIN, 10 depottabletter] EU/1/97/051/023 [MIRAPEXIN, 30 depottabletter] EU/1/97/051/024 [MIRAPEXIN, 100 depottabletter]
English: Each prolonged-release tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.52 mg pramipexole.
Danish: Hver depottablet indeholder 0,75 mg pramipexol dihydrochloridmonohydrat svarende til 0,52 mg pramipexol.
English: - Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs).
Danish: • Unormale, ufrivillige bevægelser (dyskinesi)
English: All strengths of MIRAPEXIN are available in aluminium blister strips of 10 tablets per strip, in cartons containing 3 or 10 blister strips (30 or 100 tablets).
Danish: MIRAPEXIN findes i blisterpakninger med 10 tabletter i hver blisterstrip.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/019 [10 prolonged-release tablets] EU/1/97/051/020 [30 prolonged-release tablets] EU/1/97/051/021 [100 prolonged-release tablets]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/051/019 [MIRAPEXIN, 10 depottabletter] EU/1/97/051/020 [MIRAPEXIN, 30 depottabletter] EU/1/97/051/021 [MIRAPEXIN, 100 depottabletter]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/028 [10 prolonged-release tablets] EU/1/97/051/029 [30 prolonged-release tablets] EU/1/97/051/030 [100 prolonged-release tablets]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/051/028 [MIRAPEXIN, 10 depottabletter] EU/1/97/051/029 [MIRAPEXIN, 30 depottabletter] EU/1/97/051/030 [MIRAPEXIN, 100 depottabletter]
English: The tablets are white to off-white, of round shape, with bevelled edges, and have a code embossed (one side with the code P1, and one side with the Boehringer Ingelheim company symbol).
Danish: Tabletterne er hvide til råhvide, runde med skrå kanter og er præget med en kode på begge sider (P1 hhv. Boehringer Ingelheim logo).