FrancophonIA/ELRC3.0 huggingface dataset:
English: The individual dose of pramipexole should be in the range of 0.26 mg of base (0.375 mg of salt) to a maximum of 3.15 mg of base (4.5 mg of salt) per day.
Icelandic: Sólarhringsskammtur pramipexóls á að vera á bilinu 0,26 mg (0,375 mg salts) til að hámarki 3,15 mg (4,5 mg salts).
English: Dopamine agonist withdrawal syndrome including apathy, anxiety, depression, fatigue, sweating and pain
Icelandic: Fráhvarfsheilkenni dópamínörva, þ.m.t. sinnuleysi, kvíði, þunglyndi, þreyta, svitamyndun og verkir
English: Each tablet contains 0.088 mg pramipexole (as 0.125 mg pramipexole dihydrochloride monohydrate).
Icelandic: Hver tafla inniheldur 0,088 mg af pramipexóli (sem 0,125 mg af pramipexól tvíhýdróklóríð einhýdrati).
English: 2 tablets Oprymea 0.18 mg
Icelandic: 2 Oprymea 0,18 mg töflur
English: Oprymea 0.7 mg tablets Pramipexole
Icelandic: Oprymea 0,7 mg töflur Pramipexól
English: Oprymea 0.18 mg tablets are white, oval, with bevelled edges, both sides scored, with imprint "P7" on both halves of one side of the tablet.
Icelandic: Oprymea 0,18 mg töflur eru hvítar sporöskjulaga, með skáskornum brúnum, deiliskoru á báðum hliðum og merktar „P7“á báðum helmingum á annarri hlið töflunnar.
English: Oprymea 0.70 mg tablets are white, round, with bevelled edges, both sides scored, with imprint "P9" on both halves of one side of the tablet.
Icelandic: Oprymea 0,7 mg töflur eru hvítar kringlóttar, með skáskornum brúnum, deiliskoru á báðum hliðum og merktar „P9“á báðum helmingum á annarri hlið töflunnar.
English: Oprymea 3.15 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P5 on one side and 315 on the other side, with bevelled edges and possible spots.
Icelandic: Oprymea 3,15 mg forðatöflur eru hvítar eða nánast hvítar, kringlóttar (10 mm í þvermál), örlítið tvíkúptar töflur, ígreyptar með P5 á annarri hliðinni og 315 á hinni hliðinni, með skásniðnum brúnum og hugsanlega með blettum.
English: Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Icelandic: Mælt er með reglulegum augnskoðunum eða ef sjóntruflanir koma fram.
English: - 7 prolonged-release tablets of 0.52 mg
Icelandic: - 7 forðatöflur með 0,52 mg
English: For the side effects marked with * a precise frequency estimation is not possible, since these side effects were not observed in clinical studies among 2,762 patients treated with pramipexole.
Icelandic: Nákvæmt mat á tíðni fyrir aukaverkanir merktar með* er ekki mögulegt þar sem þessar aukaverkanir komu ekki fram í klínískum rannsóknum með 2.762 sjúklingum sem fengu meðferð með pramipexóli.
English: Oprymea 2.62 mg prolonged-release tablets Pramipexole
Icelandic: Oprymea 2,62 mg forðatöflur Pramipexól
English: Tell your doctor if you have or have had or develop any medical conditions or symptoms, especially any of the following: - Kidney disease - Hallucinations (seeing, hearing or feeling things that are not there).
Icelandic: Láttu lækninn vita ef þú ert með, hefur haft eða færð einhvern sjúkdómskvilla, eða einkenni, sérstaklega eitthvað af eftirtöldu: - nýrnasjúkdóm.
English: Oprymea prolonged-release tablets are a once-a-day oral formulation of pramipexole.
Icelandic: Oprymea forðatöflur eru lyfjaform af pramipexóli til inntöku einu sinni á sólarhring.
English: 2 tablets Oprymea 0.18 mg three times a day
Icelandic: EÐA 2 Oprymea 0,18 mg töflur þrisvar sinnum á sólarhring
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 pramipexole.
Icelandic: Gera skal sjúklingum og umönnunaraðilum grein fyrir að einkenni hvatastjórnunarröskunar, þ.m.t. sjúkleg spilafíkn, aukin kynhvöt, kynlífsfíkn, eyðslu- eða kaupárátta, átköst og áráttuát, geta komið fram hjá sjúklingum sem eru meðhöndlaðir með dópamínörvum, þar á meðal pramipexóli.
English: 4 tablets Oprymea 0.088 mg
Icelandic: 4 Oprymea 0,088 mg töflur
English: White, round, with bevelled edges, both sides scored, with imprint "P9" on both halves of one side of the tablet.
Icelandic: Hvítar, kringlóttar með skáskornum brúnum, deiliskoru á báðum hliðum og merktar „P9“ á báðum helmingum á annarri hlið töflunnar.
English: In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson' s disease.
Icelandic: Hjá sjúklingum dregur pramipexól úr einkennum Parkinsonsveiki.
English: During the first week, the usual dose is 1 tablet Oprymea 0.088 mg three times a day (equivalent to 0.264 mg daily):
Icelandic: 1 Oprymea 0,088 mg tafla þrisvar sinnum á sólarhring (jafngildir 0,264 mg á sólarhring).
English: What Oprymea contains - The active substance is pramipexole.
Icelandic: - Virka innihaldsefnið er pramipexól.
English: The elimination of pramipexole is dependent on renal function.
Icelandic: Pramipexól frásogast vel eftir inntöku.
English: In particular, you may experience forward flexion of the head and neck (also called antecollis), forward bending of the lower back (also called camptocormia) or sidewards bending of the back
Icelandic: Þú getur einkum fundið fyrir framsveigju á höfði og hálsi, bakboga eða hliðarsveigju á hrygg (Pisa heilkenni).
English: LABELLING AND PACKAGE LEAFLET
Icelandic: Oprymea og pakkningastærðir
English: White or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P13 on one side and 262 on the other side, with bevelled edges and possible spots.
Icelandic: Hvítar eða nánast hvítar, kringlóttar (þvermál 10 mm), örlítið tvíkúptar töflur, ígreyptar með P13 á annarri hliðinni og 262 á hinni hliðinni, með skásniðnum brúnum og hugsanlega með blettum.
English: Oprymea 2.62 mg prolonged-release tablets
Icelandic: Oprymea 2,62 mg forðatöflur
English: White, oval, with bevelled edges, both sides scored, with imprint "P8" on both halves of one side of the tablet.
Icelandic: Hvítar, sporöskjulaga með skáskornum brúnum, deiliskoru á báðum hliðum og merktar „P8“ á báðum helmingum á annarri hlið töflunnar.
English: White or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P5 on one side and 315 on the other side, with bevelled edges and possible spots.
Icelandic: Hvítar eða nánast hvítar, kringlóttar (þvermál 10 mm), örlítið tvíkúptar töflur ígreyptar með P5 á annarri hliðinni og 315 á hinni hliðinni með skásniðnum brúnum og hugsanlega með blettum.
English: Antipsychotic medicinal products
Icelandic: LYFJAFRÆÐILEGAR UPPLÝSINGAR
English: Parkinson's disease The daily dose is to be taken divided into 3 equal doses.
Icelandic: Parkinsonsveiki Sólarhringsskammt á að taka í 3 jöfnum skömmtum.
English: Oprymea 0.26 mg Oprymea 0.52 mg Oprymea 1.05 mg prolonged-release tablets
Icelandic: Oprymea 0,26 mg Oprymea 0,52 mg Oprymea 1,05 mg forðatöflur
English: 1 tablet Oprymea 0.35 mg and 1 tablet Oprymea 0.18 mg
Icelandic: Oprymea 0,35 mg tafla og 1 Oprymea 0,18 mg tafla EÐA 3 Oprymea 0,18 mg töflur EÐA 6 Oprymea 0,088 mg töflur
English: Each tablet contains 0.7 mg pramipexole (as 1 mg pramipexole dihydrochloride monohydrate).
Icelandic: Hver tafla inniheldur 0,7 mg af pramipexóli (sem 1 mg af pramipexól tvíhýdróklóríð einhýdrati).
English: Each tablet contains 0.18 mg pramipexole (as 0.25 mg pramipexole dihydrochloride monohydrate).
Icelandic: Hver tafla inniheldur 0,18 mg af pramipexóli (sem 0,25 mg af pramipexól tvíhýdróklóríð einhýdrati).
English: Oprymea 0.26 mg Oprymea 0.52 mg Oprymea 1.05 mg prolonged-release tablets Pramipexole
Icelandic: Oprymea 0,26 mg Oprymea 0,52 mg Oprymea 1,05 mg forðatöflur Pramipexól
English: Renal impairment The elimination of pramipexole is dependent on renal function.
Icelandic: Brotthvarf Brotthvarf verður aðallega með útskilnaði á óbreyttu pramipexóli um nýru.
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: Blister pack (Alu/Alu foil): 20, 30, 60, 90 or 100 tablets, in a box.
Icelandic: 20, 30, 60, 90 eða 100 töflur í öskju.
English: Oprymea 3.15 mg prolonged-release tablets Pramipexole
Icelandic: Oprymea 3,15 mg forðatöflur Pramipexól
English: 1 tablet Oprymea 0.18 mg three times a day OR
Icelandic: Fjöldi taflna 1 Oprymea 0,18 mg tafla þrisvar sinnum á sólarhring
English: Each tablet contains 1.1 mg pramipexole (as 1.5 mg pramipexole dihydrochloride monohydrate).
Icelandic: Hver tafla inniheldur 1,1 mg af pramipexóli (sem 1,5 mg af pramipexól tvíhýdróklóríð einhýdrati).
English: 1 tablet Oprymea 0.35 mg three times a day OR
Icelandic: Oprymea 0,35 mg tafla þrisvar sinnum á sólarhring
English: Pramipexole is commonly associated with somnolence and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (see also section 4.4).
Icelandic: Tengsl eru á milli pramipexóls og svefndrunga (8,6%) og það hefur einnig verið tengt tilvikum um mikinn svefndrunga að degi til og skyndilegum svefni (0,1%).
English: (eating more food than normal and more than is needed to satisfy your hunger)* - Mania (agitation, feeling elated or over-excited)* - Delirium (decreased awareness, confusion, loss of reality)*
Icelandic: - Oflæti (æsingur, ofsakæti eða óhóflega spennt(ur))* - Óráð (minnkuð árvekni, rugl, missir raunveruleikaskyns)*
English: White, oval, with bevelled edges, both sides scored, with imprint "P7" on both halves of one side of the tablet.
Icelandic: Hvítar sporöskjulaga með skáskornum brúnum, deiliskoru á báðum hliðum og merktar „P7“ á báðum helmingum á annarri hlið töflunnar.
English: Each tablet contains 0.35 mg pramipexole (as 0.5 mg pramipexole dihydrochloride monohydrate).
Icelandic: Hver tafla inniheldur 0,35 mg af pramipexóli (sem 0,5 mg af pramipexól tvíhýdróklóríð einhýdrati).
English: LIST OF EXCIPIENTS
Icelandic: Lýsingar á völdum aukaverkunum
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 aukaverkunu.
English: Longer term efficacy was evaluated in a placebo-controlled clinical trial.
Icelandic: Langtíma verkun var metin í klínískri samanburðarrannsókn með lyfleysu.
English: Each prolonged-release tablet contains 1.57 mg pramipexole (as 2.25 mg pramipexole dihydrochloride monohydrate).
Icelandic: Hver forðatafla inniheldur 1,57 mg af pramipexóli (sem 2,25 mg af pramipexól tvíhýdróklóríð einhýdrati).
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.
Icelandic: Upphafsskammtur er 0,264 mg (0,375 mg salts) á sólarhring og skal hann aukinn smám saman á 5-7 daga fresti.
English: Very common: - Nausea (sickness).
Icelandic: - geðveiki (t.d. sambærileg einkenni og við geðklofa).
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.
Icelandic: Upphafsskammtur er 0,26 mg (0,375 mg salts) á sólarhring og skal hann aukinn smám saman á 5-7 daga fresti.
English: Endocrine inappropriate disorders antidiuretic hormone secretion
Icelandic: Innkirtlar óeðlileg seyting þvagstemmuvaka
English: Oprymea 0.088 mg tablets Pramipexole
Icelandic: Oprymea 0,088 mg tafla
English: Each prolonged-release tablet contains 1.05 mg pramipexole (as 1.5 mg pramipexole dihydrochloride monohydrate).
Icelandic: Hver forðatafla inniheldur 1,05 mg af pramipexóli (sem 1,5 mg af pramipexól tvíhýdróklóríð einhýdrati).
English: Each prolonged-release tablet contains 3.15 mg pramipexole (as 4.5 mg pramipexole dihydrochloride monohydrate).
Icelandic: Hver forðatafla inniheldur 3,15 mg af pramipexóli (sem 4,5 mg af pramipexól tvíhýdróklóríð einhýdrati).
English: Oprymea 1.57 mg prolonged-release tablets Pramipexole
Icelandic: Oprymea 1,57 mg forðatöflur Pramipexól
English: Oprymea 3.15 mg prolonged-release tablets
Icelandic: Oprymea 3,15 mg forðatöflur
English: EU/1/08/469/001[20 tablets] EU/1/08/469/002 [30 tablets] EU/1/08/469/003 [60 tablets] EU/1/08/469/004 [90 tablets] EU/1/08/469/005 [100 tablets]
Icelandic: EU/1/08/469/001 [20 töflur] EU/1/08/469/002 [30 töflur] EU/1/08/469/003 [60 töflur] EU/1/08/469/004 [90 töflur] EU/1/08/469/005 [100 töflur]
English: (mg of base)
Icelandic: (Titration step)
English: Each prolonged-release tablet contains 2.1 mg pramipexole (as 3 mg pramipexole dihydrochloride monohydrate).
Icelandic: Hver forðatafla inniheldur 2,1 mg af pramipexóli (sem 3 mg af pramipexól tvíhýdróklóríð einhýdrati).
English: Hepatic impairment
Icelandic: - Höfuðverkur
English: EU/1/08/469/011 [20 tablets] EU/1/08/469/012 [30 tablets] EU/1/08/469/013 [60 tablets] EU/1/08/469/014 [90 tablets] EU/1/08/469/015 [100 tablets]
Icelandic: EU/1/08/469/011 [20 töflur] EU/1/08/469/012 [30 töflur] EU/1/08/469/013 [60 töflur] EU/1/08/469/014 [90 töflur] EU/1/08/469/015 [100 töflur]
English: Oprymea 1.05 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P3 on one side, with bevelled edges and possible spots.
Icelandic: Oprymea 1,05 mg forðatöflur eru hvítar eða nánast hvítar kringlóttar (10 mm í þvermál), örlítið tvíkúptar töflur, ígreyptar með P3 á annarri hliðinni, með skásniðnum brúnum og hugsanlega með blettum.
English: EU/1/08/469/050 [10 prolonged-release tablets] EU/1/08/469/051 [30 prolonged-release tablets] EU/1/08/469/052 [90 prolonged-release tablets] EU/1/08/469/053 [100 prolonged-release tablets]
Icelandic: EU/1/08/469/050 [10 forðatöflur] EU/1/08/469/051 [30 forðatöflur] EU/1/08/469/052 [90 forðatöflur] EU/1/08/469/053 [100 forðatöflur]
English: EU/1/08/469/021 [20 tablets] EU/1/08/469/022 [30 tablets] EU/1/08/469/023 [60 tablets] EU/1/08/469/024 [90 tablets] EU/1/08/469/025 [100 tablets]
Icelandic: EU/1/08/469/021 [20 töflur] EU/1/08/469/022 [30 töflur] EU/1/08/469/023 [60 töflur] EU/1/08/469/024 [90 töflur] EU/1/08/469/025 [100 töflur]
English: You should avoid taking Oprymea together with antipsychotic medicines.
Icelandic: Varast ber að nota Oprymea samhliða notkun geðrofslyfja.
English: EU/1/08/469/006 [20 tablets] EU/1/08/469/007 [30 tablets] EU/1/08/469/008 [60 tablets] EU/1/08/469/009 [90 tablets] EU/1/08/469/010 [100 tablets]
Icelandic: EU/1/08/469/006 [20 töflur] EU/1/08/469/007 [30 töflur] EU/1/08/469/008 [60 töflur] EU/1/08/469/009 [90 töflur] EU/1/08/469/010 [100 töflur]
English: Oprymea 1.57 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P12 on one side, with bevelled edges and possible spots.
Icelandic: Oprymea 1,57 mg forðatöflur eru hvítar eða nánast hvítar kringlóttar (10 mm í þvermál), örlítið tvíkúptar töflur, ígreyptar með P12 á annarri hliðinni, með skásniðnum brúnum og hugsanlega með blettum.
English: Oprymea 2.1 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P4 on one side, with bevelled edges and possible spots.
Icelandic: Oprymea 2,1 mg forðatöflur eru hvítar eða nánast hvítar kringlóttar (10 mm í þvermál), örlítið tvíkúptar töflur, ígreyptar með P4 á annarri hliðinni, með skásniðnum brúnum og hugsanlega með blettum.
English: EU/1/08/469/034 [10 prolonged-release tablets] EU/1/08/469/035 [30 prolonged-release tablets] EU/1/08/469/036 [90 prolonged-release tablets] EU/1/08/469/037 [100 prolonged-release tablets]
Icelandic: EU/1/08/469/034 [10 forðatöflur] EU/1/08/469/035 [30 forðatöflur] EU/1/08/469/036 [90 forðatöflur] EU/1/08/469/037 [100 forðatöflur]
English: EU/1/08/469/016 [20 tablets] EU/1/08/469/017 [30 tablets] EU/1/08/469/018 [60 tablets] EU/1/08/469/019 [90 tablets] EU/1/08/469/020 [100 tablets]
Icelandic: EU/1/08/469/016 [20 töflur] EU/1/08/469/017 [30 töflur] EU/1/08/469/018 [60 töflur] EU/1/08/469/019 [90 töflur] EU/1/08/469/020 [100 töflur]
English: Oprymea 1.57 mg prolonged-release tablets
Icelandic: Oprymea 1,57 mg forðatöflur
English: You should have regular eye examinations during treatment with Oprymea - Severe heart or blood vessels disease.
Icelandic: Þú þarft að fara reglulega í augnskoðun meðan á Oprymea meðferð stendur.
English: Oprymea 1.05 mg prolonged-release tablets Pramipexole
Icelandic: Oprymea 1,05 mg forðatöflur Pramipexól
English: EU/1/08/469/042 [10 prolonged-release tablets] EU/1/08/469/043 [30 prolonged-release tablets] EU/1/08/469/044 [90 prolonged-release tablets] EU/1/08/469/045 [100 prolonged-release tablets]
Icelandic: EU/1/08/469/042 [10 forðatöflur] EU/1/08/469/043 [30 forðatöflur] EU/1/08/469/044 [90 forðatöflur] EU/1/08/469/045 [100 forðatöflur]
English: Oprymea 0.52 mg prolonged-release tablets Pramipexole
Icelandic: Oprymea 0,52 mg forðatöflur Pramipexól
English: Each prolonged-release tablet contains 0.26 mg pramipexole (as 0.375 mg pramipexole dihydrochloride monohydrate).
Icelandic: Hver forðatafla inniheldur 0,26 mg af pramipexóli (sem 0,375 mg af pramipexól tvíhýdróklóríð einhýdrati).
English: The following dose schedule is suggested:
Icelandic: Í fylgiseðlinum eru eftirfarandi kaflar:
English: Oprymea 0.52 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P2 on one side, with bevelled edges and possible spots.
Icelandic: Oprymea 0,52 mg forðatöflur eru hvítar eða nánast hvítar, kringlóttar (10 mm í þvermál), örlítið tvíkúptar töflur, ígreyptar með P2 á annarri hliðinni með skásniðnum brúnum og hugsanlega með blettum.
English: EU/1/08/469/046 [10 prolonged-release tablets] EU/1/08/469/047 [30 prolonged-release tablets] EU/1/08/469/048 [90 prolonged-release tablets] EU/1/08/469/049 [100 prolonged-release tablets]
Icelandic: EU/1/08/469/046 [10 forðatöflur] EU/1/08/469/047 [30 forðatöflur] EU/1/08/469/048 [90 forðatöflur] EU/1/08/469/049 [100 forðatöflur]
English: In patients with a creatinine clearance less than 20 ml/min, the daily dose of Oprymea 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 Oprymea í einum stökum skammti og byrja með 0,088 mg (0,125 mg salts) á sólarhring.
English: 1 tablet Oprymea 0.088 mg three times a day
Icelandic: Oprymea 0,088 mg tafla þrisvar sinnum á sólarhring
English: EU/1/08/469/030 [10 prolonged-release tablets] EU/1/08/469/031[30 prolonged-release tablets] EU/1/08/469/032[90 prolonged-release tablets] EU/1/08/469/033[100 prolonged-release tablets]
Icelandic: EU/1/08/469/030 [10 forðatöflur] EU/1/08/469/031 [30 forðatöflur] EU/1/08/469/032 [90 forðatöflur] EU/1/08/469/033 [100 forðatöflur]
English: Oprymea 0.26 mg prolonged-release tablets Pramipexole
Icelandic: Oprymea 0,26 mg forðatöflur Pramipexól
English: - Hyperkinesia (increased movements and inability to keep still) - Weight increase - Allergic reactions (e.g. rash, itching, hypersensitivity) - Fainting - Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)* - Inappropriate antidiuretic hormone secretion* - Restlessness - Dyspnoea (difficulties to breathe) - Hiccups - Pneumonia (infection of the lungs) - Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
Icelandic: - Hjartabilun (hjartavandamál sem geta valdið mæði eða ökklabjúg)* - Óeðlileg seyting þvagstemmuvaka* - Aukið át (taumlaust át, matgræðgi) - Hreyfitruflun (t.d. óeðlilegar, ósjálfráðar hreyfingar útlima)
English: Blister
Icelandic: Lyfhrif
English: Mannitol
Icelandic: LOTUNÚMER
English: Prolonged-release tablet
Icelandic: - Hiksti - Lungnabólga (sýking í lunga)
English: Oprymea 2.1 mg prolonged-release tablets Pramipexole
Icelandic: Oprymea 2,1 mg forðatöflur Pramipexól
English: EU/1/08/469/038 [10 prolonged-release tablets] EU/1/08/469/039 [30 prolonged-release tablets] EU/1/08/469/040 [90 prolonged-release tablets] EU/1/08/469/041 [100 prolonged-release tablets]
Icelandic: EU/1/08/469/038 [10 forðatöflur] EU/1/08/469/039 [30 forðatöflur] EU/1/08/469/040 [90 forðatöflur] EU/1/08/469/041 [100 forðatöflur]
English: EU/1/08/469/026 [10 prolonged-release tablets] EU/1/08/469/027 [30 prolonged-release tablets] EU/1/08/469/028 [90 prolonged-release tablets] EU/1/08/469/029 [100 prolonged-release tablets]
Icelandic: EU/1/08/469/026 [10 forðatöflur] EU/1/08/469/027 [30 forðatöflur] EU/1/08/469/028 [90 forðatöflur] EU/1/08/469/029 [100 forðatöflur]
English: There is no relevant use of Oprymea in the paediatric population for the indication of Parkinson's Disease.
Icelandic: Notkun Oprymea á ekki við hjá börnum við ábendingunni Parkinsonsveiki.
English: Oprymea 1.05 mg prolonged-release tablets
Icelandic: Oprymea 1,05 mg forðatöflur
English: White or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P1 on one side, with bevelled edges and possible spots.
Icelandic: Hvítar eða nánast hvítar, kringlóttar (þvermál 10 mm), örlítið tvíkúptar töflur ígreyptar með P1 á annarri hliðinni með skásniðnum brúnum og hugsanlega með blettum.
English: What Oprymea looks like and contents of the pack Oprymea 0.088 mg tablets are white, round, with bevelled edges and imprint "P6" on one side of the tablet.
Icelandic: Oprymea 0,088 mg töflur eru hvítar, kringlóttar með skáskornum brúnum og merktar „P6“ á annarri hlið töflunnar.
English: Placebocontrolled clinical trials included approximately 1,800 patients of Hoehn and Yahr stages I - V treated with pramipexole.
Icelandic: I-V á Hoehn og Yahr kvarða sem voru meðhöndlaðir með pramipexóli.
English: Each prolonged-release tablet contains 0.52 mg pramipexole (as 0.75 mg pramipexole dihydrochloride monohydrate).
Icelandic: Hver forðatafla inniheldur 0,52 mg af pramipexóli (sem 0,75 mg af pramipexól tvíhýdróklóríð einhýdrati).
English: 0.26 mg: White or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P1 on one side, with bevelled edges and possible spots.
Icelandic: Oprymea 0,26 mg forðatöflur eru hvítar eða nánast hvítar, kringlóttar (10 mm í þvermál), örlítið tvíkúptar töflur, ígreyptar með P1 á annarri hliðinni, með skásniðnum brúnum og hugsanlega með blettum.
English: 7 tablets of Oprymea 1.05 mg
Icelandic: Oprymea 1,05 mg töflur
English: INNER BOX (week 2)
Icelandic: YTRI ASKJA (Vika 2)
English: White or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P4 on one side, with bevelled edges and possible spots.
Icelandic: Hvítar eða nánast hvítar, kringlóttar (þvermál 10 mm), örlítið tvíkúptar töflur ígreyptar með P4 á annarri hliðinni með skásniðnum brúnum og hugsanlega með blettum.
English: White or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P3 on one side, with bevelled edges and possible spots.
Icelandic: Hvítar eða nánast hvítar, kringlóttar (þvermál 10 mm), örlítið tvíkúptar töflur ígreyptar með P3 á annarri hliðinni með skásniðnum brúnum og hugsanlega með blettum.
English: 2 tablets Oprymea 0.088 mg
Icelandic: Oprymea 0,18 mg tafla EÐA 2 Oprymea 0,088 mg töflur
English: White or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P12 on one side, with bevelled edges and possible spots.
Icelandic: Hvítar eða nánast hvítar, kringlóttar (þvermál 10 mm), örlítið tvíkúptar töflur ígreyptar með P12 á annarri hliðinni með skásniðnum brúnum og hugsanlega með blettum.
English: 0.52 mg: White or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P2 on one side, with bevelled edges and possible spots.
Icelandic: Oprymea 0,52 mg forðatöflur Hvítar eða nánast hvítar, kringlóttar (þvermál 10 mm), örlítið tvíkúptar töflur ígreyptar með P2 á annarri hliðinni með skásniðnum brúnum og hugsanlega með blettum.
English: Oprymea 0.52 mg prolonged-release tablets
Icelandic: Oprymea 0,52 mg forðatöflur