FrancophonIA/ELRC3.0 huggingface dataset:
English: Boehringer Ingelheim International GmbH D-55216 Ingelheim am Rhein Germany
Icelandic: Boehringer Ingelheim International GmbH D-55216 Ingelheim am Rhein Þýskaland
English: MIRAPEXIN is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Icelandic: Ekki er mælt með notkun MIRAPEXIN fyrir börn og unglinga yngri en 18 ára þar sem ekki liggja fyrir nægjanlegar upplýsingar um öryggi og verkun.
English: Cartons containing 1, 3 or 10 blister strips (10, 30 or 100 prolonged-release tablets).
Icelandic: Öskjur með 1, 3 eða 10 þynnuspjöldum (10, 30 eða 100 töflur).
English: It is recommended that the dose of levodopa is reduced during both the dose escalation and the maintenance treatment with MIRAPEXIN, depending on reactions in individual patients (see section
Icelandic: Mælt er með að minnka skammta af levódópa bæði við skammtaaukningu og viðhaldsmeðferð með MIRAPEXIN, háð svörun hvers sjúklings (sjá kafla 4.5).
English: MIRAPEXIN 0.7 mg tablets are white, of round shape, and flat.
Icelandic: MIRAPEXIN 0,7 mg töflur eru hvítar, kringlóttar og flatar.
English: Patients already taking MIRAPEXIN tablets may be switched to MIRAPEXIN prolonged-release tablets overnight, at the same daily dose.
Icelandic: Sjúklingar sem eru þegar að taka MIRAPEXIN töflur geta byrjað meðferð með MIRAPEXIN forðatöflum strax daginn eftir að síðasta MIRAPEXIN taflan er tekin og notað sama sólarhringsskammt.
English: The recommended starting dose of MIRAPEXIN is 0.088 mg of base (0.125 mg of salt) taken once daily 2-3 hours before bedtime.
Icelandic: Ráðlagður byrjunarskammtur af MIRAPEXIN er 0,088 mg (0,125 mg salts) einu sinni á sólarhring, 2-3 klst. fyrir háttatíma.
English: Each tablet contains 0.088 mg, 0.18 mg, 0.35 mg, or 0.7 mg pramipexole as 0.125 mg, 0.25 mg, 0.5 mg, or 1 mg pramipexole dihydrochloride monohydrate, respectively.
Icelandic: Hver MIRAPEXIN tafla inniheldur 0,088 mg, 0,18 mg, 0,35 mg eða 0,7 mg af pramipexóli sem samsvarar 0,125 mg, 0,25 mg, 0,5 mg eða 1 mg af pramipexól tvíhýdróklóríð einhýdrati.
English: When prescribing MIRAPEXIN in a patient with Parkinson's disease with renal impairment a reduced dose is suggested in line with section 4.2.
Icelandic: Þegar MIRAPEXIN er ávísað handa Parkinsonssjúklingum með skerta nýrnastarfsemi er lagt til að litlir skammtar séu notaðir, samsvarandi þeim sem eru tilgreindir í kafla 4.2.
English: A lower maintenance dose of three MIRAPEXIN 0.088 mg tablets a day is also possible.
Icelandic: Minni viðhaldskammtur, þrjár MIRAPEXIN 0,088 mg töflur á sólarhring er einnig hugsanlegur.
English: Take your MIRAPEXIN (immediate release) tablets as normal the day before you switch.
Icelandic: Taktu venjulegan skammt af MIRAPEXIN töflum daginn fyrir skiptin.
English: Very common may affect more than 1 in 10 people Common may affect up to 1 in 10 people
Icelandic: geta komið fyrir hjá fleiri en 1 af hverjum 10 einstaklingum
English: The efficacy and tolerability of an overnight switch from MIRAPEXIN tablets to MIRAPEXIN prolonged-release tablets at the same daily dose were evaluated in a double-blind clinical study in patients with early Parkinson's disease.
Icelandic: Verkun og þolanleiki, þegar skipt er úr meðferð með MIRAPEXIN töflum í MIRAPEXIN forðatöflur í sömu sólarhringsskömmtum strax daginn eftir að síðasta MIRAPEXIN taflan er tekin, var metin í tvíblindri klínískri rannsókn hjá sjúklingum með Parkinsonsveiki á fyrri stigum.
English: The other ingredients are mannitol, maize starch, anhydrous colloidal silica, povidone K 25 and magnesium stearate.
Icelandic: Mannitól, maíssterkja, vatnsfrí kísilkvoða, póvidón K 25, magnesíumsterat.
English: The daily dose should not exceed 6 tablets MIRAPEXIN 0.088 mg or a dose of 0.54 mg (0.75 mg pramipexole salt).
Icelandic: Sólarhrings skammtur á ekki að vera stærri en sex MIRAPEXIN 0,088 mg töflur eða sem nemur 0,54 mg skammti (0,75 mg pramipexól salt).
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 MIRAPEXIN prolonged-release tablets was detected.
Icelandic: Hins vegar komu ekki fram klínískt mikilvæg áhrif líkamsþyngdar á meðferðarsvörun og þolanleika MIRAPEXIN forðataflna í fasa III rannsóknum hjá sjúklingum með Parkinsonsveiki.
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 MIRAPEXIN.
Icelandic: Gera skal sjúklingum og umönnunaraðilum grein fyrir að einkenni hvatastjórnunarröskunar, þar með talið sjúkleg spilafíkn, aukin kynhvöt, kynlífsfíkn, eyðslu- eða kaupárátta, átköst og áráttuát, geta komið fram hjá hjá sjúklingum sem eru meðhöndlaðir með dópamínörvum þar með talið með MIRAPEXIN.
English: A precise frequency estimation is not possible as the side effect did not occur in a clinical trial database of 2,762 patients with Parkinson's Disease treated with pramipexole.
Icelandic: Nákvæmt mat á tíðni er ekki mögulegt þar sem þessi aukaverkun kom ekki fram í gagnagrunni klínískra rannsókna með 2.762 sjúklingum með Parkinsonsveiki sem fengu meðferð með pramipexóli.
English: Other medicines and MIRAPEXIN
Icelandic: Notkun annarra lyfja samhliða MIRAPEXIN
English: During the first week, the usual dose is 1 tablet MIRAPEXIN 0.088 mg three times a day (equivalent to 0.264 mg daily):
Icelandic: Fyrstu vikuna er venjulegur skammtur ein MIRAPEXIN 0,088 mg tafla þrisvar sinnum á sólarhring (jafngildir 0,264 mg á sólarhring).
English: MIRAPEXIN has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson's disease.
Icelandic: Tengsl hafa sést á milli notkunar MIRAPEXIN og syfju og þekkt eru tilfelli þar sem sjúklingur fellur skyndilega í svefn, sérstaklega sjúklingar með Parkinsonsveiki.
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.
Icelandic: I rannsókn, þar sem metnar voru pramipexól töflur og forðatöflur á fastandi maga kom í ljós að lágmarksplasmaþéttni og hámarksplasmaþéttni (Cmin, Cmax) og útsetning (AUC) var jafngild við sömu sólarhringsskammta af MIRAPEXIN forðatöflum teknar einu sinni á sólarhring og MIRAPEXIN töflum teknar 3svar á sólarhring.
English: Patients with kidney disease If you have severe kidney disease, MIRAPEXIN may not be a suitable treatment for you.
Icelandic: Ef þú ert með alvarlegan nýrnasjúkdóm er hugsanlegt að MIRAPEXIN henti þér ekki.
English: - Uncontrollable excessive shopping or spending*
Icelandic: - Stjórnlaus og óhófleg innkaup eða eyðsla*.
English: Clinical efficacy and safety in Tourette Disorder
Icelandic: Verkun og öryggi viðTourette sjúkdómi
English: Each blister strip contains 10 prolonged-release tablets.
Icelandic: Í hverju þynnuspjaldi eru 10 forðatöflur.
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).
Icelandic: Láttu lækninn vita ef þú eða fjölskylda þín/umönnunaraðili taka eftir að þú ert farin(n) að sýna einkenni oflætis (æsingur, ofsakæti eða óhóflega spennt(ur)) eða óráðs (minnkuð árvekni, rugl, missir raunveruleikaskyns).
English: MIRAPEXIN 0.18 mg tablets and MIRAPEXIN 0.35 mg tablets are white, of oval shape, and flat.
Icelandic: MIRAPEXIN 0,18 mg töflur og 0,35 mg töflur eru hvítar, sporöskjulaga og flatar.
English: The following dose schedule is suggested:
Icelandic: Önnur innihaldsefni eru:
English: - treat the symptoms of moderate to severe primary Restless Legs Syndrome in adults.
Icelandic: meðhöndlunar á einkennum á miðlungs til alvarlegrar frumkominnar fótaóeirðar hjá fullorðnum.
English: 1 tablet MIRAPEXIN 0.7 mg and 1 tablet MIRAPEXIN 0.35 mg three times a day
Icelandic: 1 MIRAPEXIN 0,7 mg tafla og 1 MIRAPEXIN 0,35 mg tafla þrisvar sinnum á sólarhring
English: If use of MIRAPEXIN is unavoidable, breast-feeding should be stopped.
Icelandic: Ef ekki er hægt að komast hjá notkun MIRAPEXIN skal hætta brjóstagjöf.
English: If you have advanced Parkinson's disease and are also taking levodopa, you might develop dyskinesia during the uptitration of MIRAPEXIN.
Icelandic: Ef þú er með langt gengna Parkinsonsveiki og ert einnig að taka levódópa getur þú fengið hreyfingatregðu meðan verið er að auka MIRAPEXIN skammta.
English: MIRAPEXIN is used to treat the symptoms of primary Parkinson's disease in adults.
Icelandic: MIRAPEXIN er notað til meðhöndlunar á einkennum frumkominnar Parkinsonsveiki hjá fullorðnum.
English: If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start treatment with MIRAPEXIN.
Icelandic: Hjá þeim sem nota levódópa er ráðlagt að minnka levódópa skammt, við upphaf meðferðar með MIRAPEXIN.
English: How to store MIRAPEXIN
Icelandic: Hvernig geyma á MIRAPEXIN
English: A precise frequency estimation is not possible as the side effect did not occur in a clinical trial database of 1,395 patients with Restless Legs Syndrome treated with pramipexole
Icelandic: Nákvæmt mat á tíðni er ekki mögulegt þar sem þessi aukaverkun kom ekki fram í gagnagrunni klínískra rannsókna með 1.395 sjúklingum með fótaóeirð sem fengu meðferð með pramipexóli.
English: In severe kidney disease, the usual starting dose is just 1 tablet MIRAPEXIN 0.088 mg a day.
Icelandic: Í tilvikum alvarlegs nýrnasjúkdóms er venjulegur upphafsskammtur aðeins ein MIRAPEXIN 0,088 mg tafla á sólarhring.
English: During the first week, the usual dose is 1 tablet MIRAPEXIN 0.088 mg once a day (equivalent to 0.088 mg daily):
Icelandic: Í fyrstu viku meðferðar er venjulegur skammtur ein MIRAPEXIN 0,088 mg tafla einu sinni á sólarhring (jafngildir 0,088 mg á sólarhring).
English: - Uncontrollable excessive shopping or spending
Icelandic: - Stjórnlaus og óhófleg innkaup eða eyðsla.
English: MIRAPEXIN 0.26 mg prolonged-release tablets MIRAPEXIN 0.52 mg prolonged-release tablets MIRAPEXIN 1.05 mg prolonged-release tablets MIRAPEXIN 1.57 mg prolonged-release tablets MIRAPEXIN 2.1 mg prolonged-release tablets MIRAPEXIN 2.62 mg prolonged-release tablets MIRAPEXIN 3.15 mg prolonged-release tablets
Icelandic: MIRAPEXIN 0,26 mg forðatöflur MIRAPEXIN 0,52 mg forðatöflur MIRAPEXIN 1,05 mg forðatöflur MIRAPEXIN 1,57 mg forðatöflur MIRAPEXIN 2,1 mg forðatöflur MIRAPEXIN 2,62 mg forðatöflur MIRAPEXIN 3,15 mg forðatöflur pramipexól
English: In patients with a creatinine clearance between 20 and 50 ml/min, the initial daily dose of MIRAPEXIN 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).
Icelandic: á í upphafi að gefa sólarhringsskammt af MIRAPEXIN í tveimur skömmtum og byrja með 0,088 mg (0,125 mg salts) tvisvar sinnum á sólarhring (0,176 mg/0,25 mg salts á sólarhring).
English: The use of MIRAPEXIN tablets should be considered.
Icelandic: Íhuga má notkun MIRAPEXIN taflna.
English: Therefore, do not take MIRAPEXIN if you are pregnant unless your doctor tells you to do so.
Icelandic: Því skulu þungaðar konur ekki nota MIRAPEXIN nema læknirinn hafi ráðlagt það.
English: If you are switching from MIRAPEXIN (immediate release) tablets Your doctor will base your dose of MIRAPEXIN prolonged-release tablets on the dose of MIRAPEXIN (immediate release) tablets you were taking.
Icelandic: Læknirinn mun miða skammt þinn af MIRAPEXIN forðatöflum við þann skammt af MIRAPEXIN töflum sem þú hefur verið að nota.
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.
Icelandic: Lýsing á útliti MIRAPEXIN og pakkningastærðir MIRAPEXIN 0,26 mg og 0,52 mg forðatöflur eru hvítar til beinhvítar, kringlóttar og með sniðbrún.
English: - Severe heart or blood vessels disease.
Icelandic: alvarlegir hjarta- og æðasjúkdómar.
English: What MIRAPEXIN looks like and contents of the pack MIRAPEXIN 0.088 mg tablets are white, of round shape, flat, and without scoring.
Icelandic: Lýsing á útliti MIRAPEXIN og pakkningastærðir MIRAPEXIN 0,088 mg töflur eru hvítar, kringlóttar, flatar og ekki með deiliskoru.
English: How to take MIRAPEXIN
Icelandic: Hvernig nota á MIRAPEXIN
English: If you have moderate kidney disease, the usual starting dose is 1 tablet MIRAPEXIN 0.088 mg twice a day.
Icelandic: Þegar um er að ræða í meðallagi alvarlegan nýrnasjúkdóm er venjulegur upphafsskammtur ein MIRAPEXIN 0,088 mg tafla tvisvar sinnum á sólarhring.
English: Children and adolescents MIRAPEXIN is not recommended for use in children or adolescents under 18 years.
Icelandic: Ekki er mælt með notkun MIRAPEXIN fyrir börn og unglinga yngri en 18 ára.
English: MIRAPEXIN is used to: - treat the symptoms of primary Parkinson's disease in adults.
Icelandic: MIRAPEXIN er notað til: meðhöndlunar á einkennum frumkominnar Parkinsonsveiki hjá fullorðnum.
English: MIRAPEXIN 0.088 mg tablets MIRAPEXIN 0.18 mg tablets MIRAPEXIN 0.35 mg tablets MIRAPEXIN 0.7 mg tablets Pramipexole
Icelandic: MIRAPEXIN 0,088 mg töflur MIRAPEXIN 0,18 mg töflur MIRAPEXIN 0,35 mg töflur MIRAPEXIN 0,7 mg töflur pramipexól
English: MIRAPEXIN 0.088 mg tablets MIRAPEXIN 0.18 mg tablets MIRAPEXIN 0.35 mg tablets MIRAPEXIN 0.7 mg tablets
Icelandic: MIRAPEXIN 0,088 mg töflur MIRAPEXIN 0,18 mg töflur MIRAPEXIN 0,35 mg töflur MIRAPEXIN 0,7 mg töflur
English: In particular, you may experience forward flexion of the head and neck (also called antecollis),
Icelandic: Þú getur einkum fundið fyrir framsveigju á höfði og hálsi, bakboga eða hliðarsveigju á hrygg (Pisa heilkenni).
English: MIRAPEXIN 2.62 mg prolonged-release tablets EU/1/97/051/031-033
Icelandic: MIRAPEXIN 2,62 mg forðatöflur EU/1/97/051/031-033
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 February 1998
Icelandic: DAGSETNING FYRSTU ÚTGÁFU MARKAÐSLEYFIS/ENDURNÝJUNAR
English: - Sleepiness and episodes of suddenly falling asleep - Psychosis (e.g. comparable with symptoms of schizophrenia) - Vision impairment.
Icelandic: syfja eða tilfelli þar sem sjúklingurinn fellur skyndilega í svefn geðveiki (t.d. sambærileg einkenni og við geðklofa) sjónskerðing.
English: MIRAPEXIN 0.35 mg tablets EU/1/97/051/011-012
Icelandic: MIRAPEXIN 0,35 mg töflur EU/1/97/051/011-012
English: If you suffer from Restless Legs Syndrome, you may experience the following side effects:
Icelandic: Ef þú ert með fótaóeirð getur þú fundið fyrir eftirfarandi aukaverkunum
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.
Icelandic: MIRAPEXIN forðatöflur einu sinni á sólarhring valda minna flökti á plasmaþéttni pramipexóls yfir 24 klst. borið saman við pramipexól töflur 3svar á sólarhring.
English: What MIRAPEXIN contains
Icelandic: MIRAPEXIN inniheldur
English: One MIRAPEXIN 0.52 mg prolonged-release tablet, OR two MIRAPEXIN 0.26 mg prolonged-release tablets.
Icelandic: Ein MIRAPEXIN 0,52 mg forðatafla EÐA tvær MIRAPEXIN 0,26 mg forðatöflur.
English: D-55216 Ingelheim am Rhein
Icelandic: D-55216 Ingelheim am Rhein Þýskalandi.
English: Ascending dose schedule of MIRAPEXIN Week
Icelandic: Tafla með skammtaaukningu fyrir MIRAPEXIN Vika
English: MIRAPEXIN 0.088 mg tablets EU/1/97/051/001-002
Icelandic: MIRAPEXIN 0,088 mg töflur EU/1/97/051/001-002
English: In the absence of human data, MIRAPEXIN should not be used during breast-feeding.
Icelandic: Þar sem upplýsingar vantar fyrir menn á ekki að nota MIRAPEXIN handa konum með barn á brjósti.
English: MIRAPEXIN 0.35 mg tablets
Icelandic: MIRAPEXIN 0,35 mg töflur
English: MIRAPEXIN 0.7 mg tablets EU/1/97/051/005-006
Icelandic: MIRAPEXIN 0,7 mg töflur EU/1/97/051/005-006
English: Very rare may affect up to 1 in 10,000 people
Icelandic: Mjög sjaldgæfar (1/10.000 til
English: MIRAPEXIN prolonged-release tablets are a once-a-day oral formulation of pramipexole.
Icelandic: MIRAPEXIN forðatöflur eru lyfjaform af pramipexóli til inntöku einu sinni á sólarhring.
English: You should avoid taking MIRAPEXIN together with antipsychotic medicines.
Icelandic: Varast ber að nota MIRAPEXIN samhliða notkun geðrofslyfja.
English: - Dystonia (inability of keeping your body and neck straight and upright (axial dystonia)).
Icelandic: truflun á vöðvaspennu (vangeta til að halda líkamanum og hálsi í uppréttri stöðu (áslæg slekja)).
English: The symptoms include: - akinesia (loss of muscle movement) - rigid muscles - fever - unstable blood pressure - tachycardia (increased heart rate) - confusion - depressed level of consciousness (e.g. coma)
Icelandic: hreyfingatregða (missir hreyfigetu) stífir vöðvar hiti óstöðugur blóðþrýstingur hraðtaktur (aukinn hjartsláttur) rugl minnkuð meðvitund (t.d. dá)
English: MIRAPEXIN 0.18 mg tablets EU/1/97/051/003-004
Icelandic: MIRAPEXIN 0,18 mg töflur EU/1/97/051/003-004
English: MIRAPEXIN 0.52 mg prolonged-release tablets EU/1/97/051/016-018
Icelandic: MIRAPEXIN 0,52 mg forðatöflur EU/1/97/051/016-018
English: A lower maintenance dose of one MIRAPEXIN 0.26 mg prolonged-release tablet a day is also possible.
Icelandic: Minni viðhaldskammtur með einni 0,26 mg forðatöflu á sólarhring er einnig hugsanlegur.
English: Prolonged-release tablet
Icelandic: Lungnabólga (sýking í lunga)
English: MARKETING AUTHORISATION NUMBER(S) MIRAPEXIN 0.26 mg prolonged-release tablets EU/1/97/051/013-015
Icelandic: MARKAÐSLEYFISNÚMER MIRAPEXIN 0,26 mg forðatöflur EU/1/97/051/013-015
English: MIRAPEXIN 0.7 mg tablets
Icelandic: MIRAPEXIN 0,7 mg töflur
English: If you stop taking MIRAPEXIN
Icelandic: Ef hætt er að nota MIRAPEXIN
English: MIRAPEXIN 0.088 mg tablets
Icelandic: MIRAPEXIN 0,088 mg töflur
English: MIRAPEXIN 2.62 mg prolonged-release tablets
Icelandic: MIRAPEXIN 2,62 mg forðatöflur
English: If you have advanced
Icelandic: SEM EIGA AÐ KOMA FRAM Á
English: The individual dose of pramipexole should be in the range of 0.264 mg of base (0.375 mg of salt) to a maximum of 3.3 mg of base (4.5 mg of salt) per day.
Icelandic: Sólarhringsskammtur pramipexóls á að vera á bilinu 0,264 mg (0,375 mg salts) til að hámarki 3,3 mg (4,5 mg salts).
English: INFORMATION IN BRAILLE MIRAPEXIN 0.35 mg
Icelandic: UPPLÝSINGAR MEÐ BLINDRALETRI MIRAPEXIN 0,35 mg
English: D-55216 Ingelheim am Rhein Germany
Icelandic: KG D-55216 Ingelheim am Rhein Þýskaland
English: MIRAPEXIN 3.15 mg prolonged-release tablets EU/1/97/051/025-027
Icelandic: MIRAPEXIN 3,15 mg forðatöflur EU/1/97/051/025-027
English: INFORMATION IN BRAILLE MIRAPEXIN 0.7 mg
Icelandic: UPPLÝSINGAR MEÐ BLINDRALETRI MIRAPEXIN 0,7 mg
English: 1 tablet MIRAPEXIN 0.088 mg three times a day
Icelandic: 1 MIRAPEXIN 0,088 mg tafla þrisvar sinnum á sólarhring
English: MIRAPEXIN 2.1 mg prolonged-release tablets EU/1/97/051/022-024
Icelandic: MIRAPEXIN 2,1 mg forðatöflur EU/1/97/051/022-024
English: MIRAPEXIN 1.05 mg prolonged-release tablets EU/1/97/051/019-021
Icelandic: MIRAPEXIN 1,05 mg forðatöflur EU/1/97/051/019-021
English: MIRAPEXIN 0.18 mg tablets
Icelandic: MIRAPEXIN 0,18 mg töflur
English: Mannitol
Icelandic: Sundl
English: 2 tablets MIRAPEXIN 0.18 mg three times a day
Icelandic: EÐA 2 MIRAPEXIN 0,18 mg töflur þrisvar sinnum á sólarhring
English: MIRAPEXIN 1.57 mg prolonged-release tablets EU/1/97/051/028-030
Icelandic: MIRAPEXIN 1,57 mg forðatöflur EU/1/97/051/028-030
English: Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg pramipexole.
Icelandic: Hver tafla inniheldur 0,125 mg pramipexól tvíhýdróklóríð einhýdrat samsvarandi 0,088 mg pramipexól.
English: Ascending dose schedule of MIRAPEXIN prolonged-release tablets Week Daily dose (mg of base)
Icelandic: Áætlun um hækkun á skömmtum fyrir MIRAPEXIN forðatöflur Vika Sólarhringsskammtur
English: INFORMATION IN BRAILLE MIRAPEXIN 2.62 mg prolonged-release tablets
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI MIRAPEXIN 2,62 mg forðatöflur
English: two MIRAPEXIN 0.52 mg prolonged-release tablets, OR four MIRAPEXIN 0.26 mg prolonged-release tablets.
Icelandic: Ein MIRAPEXIN 1,05 mg forðatafla, EÐA tvær MIRAPEXIN 0,52 mg forðatöflur, EÐA fjórar MIRAPEXIN 0,26 mg forðatöflur.
English: MIRAPEXIN 1.05 mg prolonged-release tablets
Icelandic: MIRAPEXIN 1,05 mg forðatöflur Pramipexól
English: What is in this leaflet:
Icelandic: Meðal einkenna eru:
English: 2 tablets MIRAPEXIN 0.088 mg three times a day
Icelandic: EÐA 2 MIRAPEXIN 0,088 mg töflur þrisvar sinnum á sólarhring
English: MIRAPEXIN 1.57 mg prolonged-release tablets
Icelandic: MIRAPEXIN 1,57 mg forðatöflur
English: MIRAPEXIN 3.15 mg prolonged-release tablets
Icelandic: MIRAPEXIN 3,15 mg forðatöflur Pramipexól
English: In advanced Parkinson's disease, in combination treatment with levodopa, dyskinesia can occur during the initial titration of MIRAPEXIN.
Icelandic: Í langt genginni Parkinsonsveiki og samsettri meðferð með levódópa, getur hreyfingatregða komið fram við skammtastillingu MIRAPEXIN við upphaf meðferðar og ef svo er skal minnka levódópaskammt.
English: INFORMATION IN BRAILLE MIRAPEXIN 1.57 mg prolonged-release tablets
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI MIRAPEXIN 1,57 mg forðatöflur
English: 1 tablet MIRAPEXIN 0.35 mg three times a day OR
Icelandic: 1 MIRAPEXIN 0,35 mg tafla þrisvar sinnum á sólarhring
English: MIRAPEXIN 0.52 mg prolonged-release tablets
Icelandic: MIRAPEXIN 0,52 mg forðatöflur Pramipexól
English: 1 tablet MIRAPEXIN 0.35 mg and 1 tablet MIRAPEXIN 0.18 mg OR
Icelandic: 1 MIRAPEXIN 0,35 mg tafla og 1 MIRAPEXIN 0,18 mg tafla EÐA 3 MIRAPEXIN 0,18 mg töflur EÐA 6 MIRAPEXIN 0,088 mg töflur
English: 2 tablets MIRAPEXIN 0.088 mg
Icelandic: 2 MIRAPEXIN 0,088 mg töflur
English: Restless Legs Syndrome, most common adverse reactions The most commonly (≥ 5%) reported adverse drug reactions in patients with Restless Legs Syndrome treated with pramipexole were nausea, headache, dizziness and fatigue.
Icelandic: Algengustu ( 5%) aukaverkanirnar sem komu fram hjá sjúklingum með fótaóeirð og meðhöndlaðir voru með pramipexóli voru ógleði, höfuðverkur, sundl og þreyta.
English: Each prolonged-release tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.05 mg pramipexole.
Icelandic: Hver forðatafla inniheldur 1,5 mg pramipexól tvíhýdróklóríð einhýdrat samsvarandi 1,05 mg pramipexól.
English: In patients with a creatinine clearance less than 20 ml/min, the daily dose of MIRAPEXIN should be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily.
Icelandic: á að gefa sólarhringsskammt af MIRAPEXIN í einum stökum skammti og byrja með 0,088 mg (0,125 mg salts) á sólarhring.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg pramipexole.
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 0,25 mg pramipexól tvíhýdróklóríð einhýdrat samsvarandi 0,18 mg pramipexól.
English: INFORMATION IN BRAILLE MIRAPEXIN 1.05 mg prolonged-release tablets
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI MIRAPEXIN 1,05 mg forðatöflur
English: Each prolonged-release tablet contains 3.75 mg pramipexole dihydrochloride monohydrate equivalent to 2.62 mg pramipexole.
Icelandic: Hver forðatafla inniheldur 3,75 mg pramipexól tvíhýdróklóríð einhýdrat samsvarandi 2,62 mg pramipexól.
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]
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/051/016 [10 forðatöflur] EU/1/97/051/017 [30 forðatöflur] EU/1/97/051/018 [100 forðatöflur]
English: INFORMATION IN BRAILLE MIRAPEXIN 0.26 mg prolonged-release tablets
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI MIRAPEXIN 0,26 mg forðatöflur