FrancophonIA/ELRC3.0 huggingface dataset:
English: During dose escalation in pivotal studies, efficacy was observed starting at a daily dose of 1.1 mg of base (1.5 mg of salt).
Slovenian: Pri povečevanju odmerka so v ključnih študijah opazili učinkovitost pri dnevnem odmerku 1,1 mg pramipeksola (1,5 mg soli) in več.
English: 1 tablet Oprymea 0.088 mg three times a day
Slovenian: 1 tableta zdravila Oprymea po 0,088 mg 3-krat na dan
English: - Hallucinations (seeing, hearing or feeling things that are not there) - Confusion - Excessive daytime sleepiness and suddenly falling asleep - Weight increase - Hypotension (low blood pressure) - Excess of fluid, usually in the legs (peripheral oedema) - Allergic reactions (e.g. rash, itching, hypersensitivity) - Fainting - Restlessness - Visual impairment - Weight loss including decreased appetite - 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:
Slovenian: - hiperkinezija (čezmerni gibi in nezmožnost mirovanja)*, - paranoja (npr. prevelik strah za lastno dobrobit)*, - blodnje*, - amnezija (moten spomin)*, - halucinacije (pojav, pri katerem vidite, slišite ali čutite nekaj, česar ni), - zmedenost, - prevelika zaspanost podnevi in nenaden nepremagljiv spanec, - povečanje telesne mase, - hipotenzija (nizek krvni tlak), - preveč tekočine, običajno v nogah (periferni edem), - alergijske reakcije (npr. izpuščaj, srbenje, preobčutljivost), - omedlevica, - nemir, - okvara vida, - hujšanje, tudi zmanjšan tek, - dispneja (težave pri dihanju), - kolcanje, - pljučnica (vnetje pljuč)*, - nezmožnost upreti se impulzu, težnji ali skušnjavi po dejanjih, ki bi lahko škodila vam ali drugim, kot so:
English: Focus Care Pharmaceuticals B.V. Tel: +31 (0)75 612 05 11
Slovenian: Tel: +31 (0)75 612 05 11
English: Impulse control disorders Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including Oprymea (see section 4.4).
Slovenian: Pri bolnikih, ki so se zdravili z dopaminskimi agonisti, tudi zdravilom Oprymea, se lahko pojavijo patološko hazardiranje, povečan libido, hiperseksualnost, kompulzivno trošenje denarja ali nakupovanje, prenajedanje in kompulzivno uživanje hrane (glejte poglavje 4.4).
English: Not known: - After stopping or reducing your Oprymea treatment: Depression, apathy, anxiety, fatigue,
Slovenian: Neznana pogostnost: - Po prenehanju zdravljenja z zdravilom Oprymea ali zmanjšanju odmerka: pojavijo se lahko depresija, apatija, anksioznost, utrujenost, znojenje ali bolečina (to se imenuje sindrom odtegnitve dopaminskega agonista).
English: White, oval, with bevelled edges, both sides scored, with imprint "P8" on both halves of one side of the tablet.
Slovenian: Bele, ovalne, s posnetimi robovi in z zarezo na obeh straneh ter oznako P8 na obeh polovicah ene strani tablete.
English: Oprymea 2.62 mg prolonged-release tablets
Slovenian: Oprymea 2,62 mg tablete s podaljšanim sproščanjem
English: 1 tablet Oprymea 0.18 mg three times a day OR
Slovenian: 1 tableta zdravila Oprymea po 0,18 mg 3-krat na dan ALI
English: White, oval, with bevelled edges, both sides scored, with imprint "P7" on both halves of one side of the tablet.
Slovenian: Bele, ovalne, s posnetimi robovi in z zarezo na obeh straneh ter oznako P7 na obeh polovicah ene strani tablete.
English: The tablets should be taken orally, swallowed with water, and can be taken either with or without food.
Slovenian: Tablete je potrebno jemati peroralno in sicer pogoltniti z vodo.
English: Once Daily Evening Dose (mg of salt)
Slovenian: Enkratni večerni odmerek (mg soli)
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.
Slovenian: Natančna ocena pogostnosti neželenih učinkov, ki so označeni z * ni možna, ker jih niso opisali v kliničnih preskušanjih pri 2.762 bolnikih, ki so se zdravili s pramipeksolom.
English: Most hallucinations are visual - Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs).
Slovenian: - Diskinezija (na primer nenormalni, nenadzorovani gibi udov).
English: Oprymea 3.15 mg prolonged-release tablets
Slovenian: Oprymea 3,15 mg tablete s podaljšanim sproščanjem
English: White, round, with bevelled edges, both sides scored, with imprint "P9" on both halves of one side of the tablet.
Slovenian: Bele, okrogle, s posnetimi robovi in z zarezo na obeh straneh ter oznako P9 na obeh polovicah ene strani tablete.
English: Each prolonged-release tablet contains 2.62 mg pramipexole (as 3.75 mg pramipexole dihydrochloride monohydrate).
Slovenian: Ena tableta s podaljšanim sproščanjem vsebuje 2,62 mg pramipeksola v obliki 3,75 mg pramipeksolijevega dihidroklorida monohidrata.
English: You should have regular eye examinations during treatment with Oprymea - Severe heart or blood vessels disease.
Slovenian: Med zdravljenjem z zdravilom Oprymea morate redno hoditi na očesne preglede.
English: Oprymea 0.26 mg prolonged-release tablets
Slovenian: Oprymea 0,26 mg tablete s podaljšanim sproščanjem
English: In patients with a creatinine clearance between 30 and 50 ml/min, treatment should be started with 0.26 mg Oprymea prolonged-release tablets every other day.
Slovenian: Bolnike s kreatininskim očistkom od 30 do 50 ml/min začnemo zdraviti z Oprymea 0,26 miligramskimi tabletami s podaljšanim sproščanjem vsak drugi dan. Preden odmerek po enem tednu previdno povečamo na dnevni odmerek vsak dan, je treba natančno oceniti odzivanje na zdravljenje in prenašanje.
English: 3 tablets Oprymea 0.18 mg OR
Slovenian: 3 tablete zdravila Oprymea po 0,18 mg
English: BOX for blisters
Slovenian: ŠKATLA za pretisne omote
English: Oprymea 0.35 mg tablets Pramipexole
Slovenian: Oprymea 0,35 mg tablete pramipeksol
English: Frequency cannot be estimated from the available data
Slovenian: pojavijo se lahko pri največ 1 od 10.000 bolnikov Neznana pogostnost: pogostnosti ni mogoče oceniti iz razpoložljivih podatkov
English: In patients with a creatinine clearance between 20 and 50 ml/min, the initial daily dose of Oprymea 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).
Slovenian: Začnemo z dajanjem 0,088 mg pramipeksola (0,125 mg soli) dvakrat na dan (tj. 0,176 mg pramipeksola oz. 0,25 mg soli).
English: Each prolonged-release tablet contains 3.15 mg pramipexole (as 4.5 mg pramipexole dihydrochloride monohydrate).
Slovenian: Ena tableta s podaljšanim sproščanjem vsebuje 3,15 mg pramipeksola v obliki 4,5 mg pramipeksolijevega dihidroklorida monohidrata.
English: Oprymea 0.52 mg prolonged-release tablets
Slovenian: Oprymea 0,52 mg tablete s podaljšanim sproščanjem
English: Oprymea 0.18 mg tablets Pramipexole
Slovenian: Oprymea 0,18 mg tablete pramipeksol
English: Nervous system disorders headache dizziness somnolance sudden onset of sleep syncope dyskinesia amnesia hyperkinesia
Slovenian: Bolezni živčevja glavobol omotičnost zaspanost nenaden nepremagljiv spanec sinkopa diskinezija amnezija hiperkinezija
English: Each tablet contains 0.088 mg pramipexole (as 0.125 mg pramipexole dihydrochloride monohydrate).
Slovenian: Ena tableta vsebuje 0,088 mg pramipeksola, kar ustreza 0,125 mg pramipeksolijevega dihidroklorida monohidrata.
English: Oprymea prolonged-release tablets are a once-a-day oral formulation of pramipexole.
Slovenian: Oprymea tablete s podaljšanim sproščanjem so peroralna oblika pramipeksola za jemanje enkrat na dan.
English: Each prolonged-release tablet contains 2.1 mg pramipexole (as 3 mg pramipexole dihydrochloride monohydrate).
Slovenian: Ena tableta s podaljšanim sproščanjem vsebuje 2,1 mg pramipeksola v obliki 3 mg pramipeksolijevega dihidroklorida monohidrata.
English: 2 tablets Oprymea 0.088 mg
Slovenian: 2 tableti zdravila Oprymea po 0,088 mg
English: 4 tablets Oprymea 0.088 mg
Slovenian: 4 tablete zdravila Oprymea po 0,088 mg
English: Oprymea 0.7 mg tablets Pramipexole
Slovenian: Oprymea 0,7 mg tablete pramipeksol
English: Each prolonged-release tablet contains 1.05 mg pramipexole (as 1.5 mg pramipexole dihydrochloride monohydrate).
Slovenian: Ena tableta s podaljšanim sproščanjem vsebuje 1,05 mg pramipeksola v obliki 1,5 mg pramipeksolijevega dihidroklorida monohidrata.
English: Oprymea 0.26 mg: Each prolonged-release tablet contains 0.26 mg pramipexole (as 0.375 mg pramipexole dihydrochloride monohydrate).
Slovenian: Oprymea 0,26 mg: Ena tableta s podaljšanim sproščanjem vsebuje 0,26 mg pramipeksola v obliki 0,375 mg pramipeksolijevega dihidroklorida monohidrata.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: Skupni dnevni odmerek (mg)
English: Oprymea 0.52 mg: Each prolonged-release tablet contains 0.52 mg pramipexole (as 0.75 mg pramipexole dihydrochloride monohydrate).
Slovenian: Oprymea 0,52 mg: Ena tableta s podaljšanim sproščanjem vsebuje 0,52 mg pramipeksola v obliki 0,75 mg pramipeksolijevega dihidroklorida monohidrata.
English: Oprymea 1.57 mg prolonged-release tablets
Slovenian: Oprymea 1,57 mg tablete s podaljšanim sproščanjem
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.
Slovenian: Oprymea 3,15 mg tablete s podaljšanim sproščanjem so bele ali skoraj bele, okrogle (premera 10 mm), rahlo izbočene, s prirezanimi robovi in z morebitnimi pikami ter z vtisnjeno oznako P5 na eni strani in 315 na drugi strani.
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:
Slovenian: - amnezija (moten spomin), - hiperkinezija (čezmerni gibi in nezmožnost mirovanja), - povečanje telesne mase, - alergijske reakcije (npr. izpuščaj, srbenje, preobčutljivost) - omedlevica, - hiperseksualnost - srčno popuščanje (srčne motnje, ki lahko povzročijo težave z dihanjem in otekanje gležnjev)*, - neustrezno izločanje antidiuretičnega hormona*, - nemir, - dispneja (težave pri dihanju), - kolcanje, - pljučnica (vnetje pljuč).
English: Total daily dose (mg)
Slovenian: Enkratni večerni odmerek (mg)
English: 1 tablet Oprymea 0.18 mg OR
Slovenian: 1 tableta zdravila Oprymea po 0,18 mg ALI
English: Each prolonged-release tablet contains 1.57 mg pramipexole (as 2.25 mg pramipexole dihydrochloride monohydrate).
Slovenian: Ena tableta s podaljšanim sproščanjem vsebuje 1,57 mg pramipeksola v obliki 2,25 mg pramipeksolijevega dihidroklorida monohidrata.
English: In the absence of human data, Oprymea should not be used during breast-feeding.
Slovenian: Zaradi pomanjkanja podatkov pramipeksola ne dajemo materam, ki dojijo.
English: If a further dose increase is necessary the daily dose should be increased by 0.54 mg of base (0.75 mg of salt) at weekly intervals up to a maximum dose of 3.3 mg of base (4.5 mg of salt) per day.
Slovenian: Če je potrebno, lahko dnevni odmerek v tedenskih intervalih še povečujemo po 0,54 mg (0,75 mg soli) do največjega odmerka, to je 3,3 mg pramipeksola (4,5 mg soli).
English: 1 tablet Oprymea 0.088 mg
Slovenian: 1 tableta zdravila Oprymea po 0,088 mg
English: Warnings and precautions Talk to your doctor before taking Oprymea.
Slovenian: Pred začetkom jemanja zdravila Oprymea se posvetujte z zdravnikom.
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.
Slovenian: 0,26 mg: Bele ali skoraj bele, okrogle (premera 10 mm), rahlo izbočene tablete s prirezanimi robovi in z morebitnimi pikami ter z vtisnjeno oznako P1 na eni strani.
English: 6 tablets Oprymea 0.088 mg
Slovenian: 6 tablet zdravila Oprymea po 0,088 mg
English: Oprymea 0.35 mg tablets 20 tablets: EU/1/08/469/011 30 tablets: EU/1/08/469/012 60 tablets: EU/1/08/469/013 90 tablets: EU/1/08/469/014 100 tablets: EU/1/08/469/015
Slovenian: Oprymea 0,35 mg tablete 20 tablet: EU/1/08/469/011 30 tablet: EU/1/08/469/012 60 tablet: EU/1/08/469/013 90 tablet: EU/1/08/469/014 100 tablet: EU/1/08/469/015
English: Oprymea 1.05 mg prolonged-release tablets
Slovenian: Oprymea 1,05 mg tablete s podaljšanim sproščanjem
English: Dose (mg of salt)
Slovenian: Odmerek soli (mg)
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.
Slovenian: 0,52 mg: Bele ali skoraj bele, okrogle (premera 10 mm), rahlo izbočene tablete s prirezanimi robovi in z morebitnimi pikami ter z vtisnjeno oznako P2 na eni strani.
English: Only one patient switched to pramipexole prolonged-release tablets experienced a drug-related adverse event leading to withdrawal.
Slovenian: Z zdravilom povezan neželeni dogodek, zaradi katerega je bilo zdravljenje ukinjeno, je imel po prehodu na pramipeksol tablete s podaljšanim sproščanjem samo en bolnik.
English: Oprymea 1.1 mg tablets 20 tablets: EU/1/08/469/021 30 tablets: EU/1/08/469/022 60 tablets: EU/1/08/469/023 90 tablets: EU/1/08/469/024 100 tablets: EU/1/08/469/025
Slovenian: Oprymea 1,1 mg tablete 20 tablet: EU/1/08/469/021 30 tablet: EU/1/08/469/022 60 tablet: EU/1/08/469/023 90 tablet: EU/1/08/469/024 100 tablet: EU/1/08/469/025
English: Oprymea 0.26 mg prolonged-release tablets Each prolonged-release tablet contains 0.26 mg pramipexole (as 0.375 mg pramipexole dihydrochloride monohydrate).
Slovenian: Oprymea 0,26 mg tablete s podaljšanim sproščanjem Ena tableta s podaljšanim sproščanjem vsebuje 0,26 mg pramipeksola v obliki 0,375 mg pramipeksolijevega dihidroklorida monohidrata.
English: Oprymea 2.1 mg prolonged-release tablets
Slovenian: Oprymea 2,1 mg tablete s podaljšanim sproščanjem
English: 1.05 mg: White or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P3 on one side, with bevelled edges and possible spots.
Slovenian: 1,05 mg: Bele ali skoraj bele, okrogle (premera 10 mm), rahlo izbočene tablete s prirezanimi robovi in z morebitnimi pikami ter z vtisnjeno oznako P3 na eni strani.
English: Each tablet contains 1.1 mg pramipexole (as 1.5 mg pramipexole dihydrochloride monohydrate).
Slovenian: Ena tableta vsebuje 1,1 mg pramipeksola, kar ustreza 1,5 mg pramipeksolijevega dihidroklorida monohidrata.
English: Oprymea 0.26 mg prolonged-release tablets Oprymea 0.52 mg prolonged-release tablets Oprymea 1.05 mg prolonged-release tablets
Slovenian: Oprymea 0,26 mg tablete s podaljšanim sproščanjem Oprymea 0,52 mg tablete s podaljšanim sproščanjem Oprymea 1,05 mg tablete s podaljšanim sproščanjem
English: Each prolonged-release tablet contains 0.26 mg pramipexole (as 0.375 mg pramipexole dihydrochloride monohydrate).
Slovenian: Ena tableta s podaljšanim sproščanjem vsebuje 0,26 mg pramipeksola v obliki 0,375 mg pramipeksolijevega dihidroklorida monohidrata.
English: Oprymea 2.62 mg prolonged-release tablets 10 prolonged-release tablets: EU/1/08/469/046 30 prolonged-release tablets: EU/1/08/469/047 90 prolonged-release tablets: EU/1/08/469/048 100 prolonged-release tablets: EU/1/08/469/049
Slovenian: Oprymea 2,62 mg tablete s podaljšanim sproščanjem 10 tablet s podaljšanim sproščanjem: EU/1/08/469/046 30 tablet s podaljšanim sproščanjem: EU/1/08/469/047 90 tablet s podaljšanim sproščanjem: EU/1/08/469/048 100 tablet s podaljšanim sproščanjem: EU/1/08/469/049
English: Each prolonged-release tablet contains 0.52 mg pramipexole (as 0.75 mg pramipexole dihydrochloride monohydrate).
Slovenian: Ena tableta s podaljšanim sproščanjem vsebuje 0,52 mg pramipeksola v obliki 0,75 mg pramipeksolijevega dihidroklorida monohidrata.
English: Oprymea 0.26 mg prolonged-release tablets 10 prolonged-release tablets: EU/1/08/469/026 30 prolonged-release tablets: EU/1/08/469/027 90 prolonged-release tablets: EU/1/08/469/028 100 prolonged-release tablets: EU/1/08/469/029
Slovenian: Oprymea 0,26 mg tablete s podaljšanim sproščanjem 10 tablet s podaljšanim sproščanjem: EU/1/08/469/026 30 tablet s podaljšanim sproščanjem: EU/1/08/469/027 90 tablet s podaljšanim sproščanjem: EU/1/08/469/028 100 tablet s podaljšanim sproščanjem: EU/1/08/469/029
English: Oprymea 2.62 mg prolonged-release tablets Pramipexole
Slovenian: Oprymea 2,62 mg tablete s podaljšanim sproščanjem pramipeksol
English: Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly with Oprymea.
Slovenian: Kadar dajemo navedena zdravila sočasno z zdravilom Opymea, moramo upoštevati zmanjšanje odmerka pramipeksola.
English: Very common may affect more than 1 in 10 people Common may affect up to 1 in 10 people
Slovenian: pojavijo se lahko pri največ 1 od 10 bolnikov
English: Each tablet contains 0.7 mg pramipexole (as 1 mg pramipexole dihydrochloride monohydrate).
Slovenian: Ena tableta vsebuje 0,7 mg pramipeksola v obliki 1 mg pramipeksolijevega dihidroklorida monohidrata.
English: Oprymea 0.18 mg tablets 20 tablets: EU/1/08/469/006 30 tablets: EU/1/08/469/007 60 tablets: EU/1/08/469/008 90 tablets: EU/1/08/469/009 100 tablets: EU/1/08/469/010
Slovenian: Oprymea 0,18 mg tablete 20 tablet: EU/1/08/469/006 30 tablet: EU/1/08/469/007 60 tablet: EU/1/08/469/008 90 tablet: EU/1/08/469/009 100 tablet: EU/1/08/469/010
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]
Slovenian: EU/1/08/469/011 [20 tablet] EU/1/08/469/012 [30 tablet] EU/1/08/469/013 [60 tablet] EU/1/08/469/014 [90 tablet] EU/1/08/469/015 [100 tablet]
English: Oprymea is used to: - treat the symptoms of primary Parkinson's disease in adults.
Slovenian: Zdravilo Oprymea uporabljamo za: - zdravljenje simptomov primarne Parkinsonove bolezni pri odraslih; lahko ga uporabljamo samostojno ali v kombinaciji z levodopo (drugo zdravilo za Parkinsonovo bolezen).
English: Oprymea 3.15 mg prolonged-release tablets Pramipexole
Slovenian: Oprymea 3,15 mg tablete s podaljšanim sproščanjem pramipeksol
English: Each tablet contains 0.35 mg pramipexole (as 0.5 mg pramipexole dihydrochloride monohydrate).
Slovenian: Ena tableta vsebuje 0,35 mg pramipeksola v obliki 0,5 mg pramipeksolijevega dihidroklorid monohidrata.
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]
Slovenian: EU/1/08/469/021 [20 tablet] EU/1/08/469/022 [30 tablet] EU/1/08/469/023 [60 tablet] EU/1/08/469/024 [90 tablet] EU/1/08/469/025 [100 tablet]
English: Oprymea 1.57 mg prolonged-release tablets 10 prolonged-release tablets: EU/1/08/469/038 30 prolonged-release tablets: EU/1/08/469/039 90 prolonged-release tablets: EU/1/08/469/040 100 prolonged-release tablets: EU/1/08/469/041
Slovenian: Oprymea 1,57 mg tablete s podaljšanim sproščanjem 10 tablet s podaljšanim sproščanjem: EU/1/08/469/038 30 tablet s podaljšanim sproščanjem: EU/1/08/469/039 90 tablet s podaljšanim sproščanjem: EU/1/08/469/040 100 tablet s podaljšanim sproščanjem: EU/1/08/469/041
English: Oprymea 0.7 mg tablets 20 tablets: EU/1/08/469/016 30 tablets: EU/1/08/469/017 60 tablets: EU/1/08/469/018 90 tablets: EU/1/08/469/019 100 tablets: EU/1/08/469/020
Slovenian: Oprymea 0,7 mg tablete 20 tablet: EU/1/08/469/016 30 tablet: EU/1/08/469/017 60 tablet: EU/1/08/469/018 90 tablet: EU/1/08/469/019 100 tablet: EU/1/08/469/020
English: Each tablet contains 0.18 mg pramipexole (as 0.25 mg pramipexole dihydrochloride monohydrate).
Slovenian: Ena tableta vsebuje 0,18 mg pramipeksola, kar ustreza 0,25 mg pramipeksolijevega dihidroklorida monohidrata.
English: Ascending dose schedule of Oprymea prolonged-release tablets Week Daily dose (mg) Number of tablets
Slovenian: Shema povečevanja odmerka zdravila Oprymea tablete s podaljšanim sproščanjem Teden
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.
Slovenian: Oprymea 0,52 mg tablete s podaljšanim sproščanjem so bele ali skoraj bele, okrogle (premera 10 mm), rahlo izbočene, s prirezanimi robovi in z morebitnimi pikami ter z vtisnjeno oznako P2 na eni strani.
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]
Slovenian: EU/1/08/469/001 [20 tablet] EU/1/08/469/002 [30 tablet] EU/1/08/469/003 [60 tablet] EU/1/08/469/004 [90 tablet] EU/1/08/469/005 [100 tablet]
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.
Slovenian: Oprymea 2,1 mg tablete s podaljšanim sproščanjem so bele ali skoraj bele, okrogle (premera 10 mm), rahlo izbočene, s prirezanimi robovi in z morebitnimi pikami ter z vtisnjeno oznako P4 na eni strani.
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]
Slovenian: EU/1/08/469/006 [20 tablet] EU/1/08/469/007 [30 tablet] EU/1/08/469/008 [60 tablet] EU/1/08/469/009 [90 tablet] EU/1/08/469/010 [100 tablet]
English: Oprymea 3.15 mg prolonged-release tablets 10 prolonged-release tablets: EU/1/08/469/050 30 prolonged-release tablets: EU/1/08/469/051 90 prolonged-release tablets: EU/1/08/469/052 100 prolonged-release tablets: EU/1/08/469/053
Slovenian: Oprymea 3,15 mg tablete s podaljšanim sproščanjem 10 tablet s podaljšanim sproščanjem: EU/1/08/469/050 30 tablet s podaljšanim sproščanjem: EU/1/08/469/051 90 tablet s podaljšanim sproščanjem: EU/1/08/469/052 100 tablet s podaljšanim sproščanjem: EU/1/08/469/053
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]
Slovenian: EU/1/08/469/042 [10 tablet s podaljšanim sproščanjem] EU/1/08/469/043 [30 tablet s podaljšanim sproščanjem] EU/1/08/469/044 [90 tablet s podaljšanim sproščanjem] EU/1/08/469/045 [100 tablet s podaljšanim sproščanjem]
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]
Slovenian: EU/1/08/469/026 [10 tablet s podaljšanim sproščanjem] EU/1/08/469/027 [30 tablet s podaljšanim sproščanjem] EU/1/08/469/028 [90 tablet s podaljšanim sproščanjem] EU/1/08/469/029 [100 tablet s podaljšanim sproščanjem]
English: Oprymea 0.26 mg prolonged-release tablets Pramipexole
Slovenian: Oprymea 0,26 mg tablete s podaljšanim sproščanjem pramipeksol
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]
Slovenian: EU/1/08/469/016 [20 tablet] EU/1/08/469/017 [30 tablet] EU/1/08/469/018 [60 tablet] EU/1/08/469/019 [90 tablet] EU/1/08/469/020 [100 tablet]
English: White or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P2 on one side, with bevelled edges and possible spots.
Slovenian: Bele ali skoraj bele, okrogle (premera 10 mm), rahlo izbočene tablete s prirezanimi robovi in z morebitnimi pikami ter z vtisnjeno oznako P2 na eni strani.