FrancophonIA/ELRC3.0 huggingface dataset:
English: In a Phase I trial, where pramipexole immediate release and prolonged-release tablets were assessed in fasted state, the minimum and peak plasma concentration (Cmin, Cmax) and exposure (AUC) of the same daily dose of SIFROL prolonged-release tablets given once daily and SIFROL tablets given three times a day were equivalent.
Croatian: U ispitivanju faze I, u kojem su ocjenjivane pramipeksol tablete s trenutnim oslobađanjem i pramipeksol tablete s produljenim oslobađanjem natašte, minimalne i maksimalne koncentracije u plazmi (Cmin, Cmax) i ekspozicija (AUC) jednakoj dnevnoj dozi SIFROL tableta s produljenim oslobađanjem, primjenjivanih jedanput dnevno i SIFROL tableta primjenjivanih tri puta dnevno, bile su jednake.
English: A lower maintenance dose of three SIFROL 0.088 mg tablets a day is also possible.
Croatian: Također je moguća niža doza održavanja od tri SIFROLA 0,088 mg tablete dnevno.
English: SIFROL 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg and 3.15 mg prolonged-release tablets are white to offwhite and of oval shape.
Croatian: SIFROL 1,05 mg, 1,57 mg, 2,1 mg, 2,62 mg i 3,15 mg tablete s produljenim oslobađanjem su bijele do gotovo bijele boje i ovalnog oblika.
English: The daily dose should not exceed 6 tablets SIFROL 0.088 mg or a dose of 0.54 mg (0.75 mg pramipexole salt).
Croatian: Dnevna doza ne smije prelaziti 6 tableta SIFROL 0,088 mg ili dozu od 0,54 mg (0,75 mg soli pramipeksola).
English: There is no relevant use of SIFROL in the paediatric population for the indication of Parkinson's Disease.
Croatian: Nema relevantne primjene SIFROLA u pedijatrijskoj populaciji za indikaciju Parkinsonove bolesti.
English: Since the daily dose for the treatment of Restless Legs Syndrome will not exceed 0.54 mg of base (0.75 mg of salt) SIFROL can be discontinued without tapering off.
Croatian: S obzirom da dnevna doza u liječenju sindroma nemirnih nogu neće prelaziti 0,54 mg baze (0,75 mg soli), liječenje SIFROLOM se može prekinuti bez postupnog snižavanja doze.
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)*
Croatian: (izjedanje veće količine hrane nego što je normalno i više nego je potrebno za utaženje gladi)* - manija (agitacija, osjećaj ushita ili pretjeranog uzbuđenja)* - delirij (poremećaj svijesti, konfuzija, gubitak osjećaja za stvarnost)*
English: SIFROL is not recommended for use in children and adolescents below 18 years since the efficacy and safety has not been established in this population.
Croatian: Primjena SIFROLA se ne preporučuje u djece i adolescenata u dobi do 18 godina jer njegova sigurnost i djelotvornost nije ustanovljena za ovu populaciju.
English: The use of SIFROL has not been studied in haemodialysis patients, or in patients with severe renal impairment.
Croatian: Primjena SIFROLA nije ispitivana u bolesnika na hemodijalizi, ili bolesnika s teškim bubrežnim oštećenjem.
English: Patients with kidney disease If you have severe kidney disease, SIFROL may not be a suitable treatment for you.
Croatian: Ako imate tešku bolest bubrega, SIFROL možda neće biti prikladan za Vaše liječenje.
English: Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
Croatian: Pramipeksol se u vrlo maloj mjeri veže na proteine plazme (<20%), te se vrlo malo biotransformira u ljudi.
English: In patients with a creatinine clearance between 20 and 50 ml/min, the initial daily dose of SIFROL 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).
Croatian: U bolesnika s klirensom kreatinina između 20 i 50 ml/min, početna dnevna doza SIFROLA treba se podijeliti u dvije odvojene doze, počevši od 0,088 mg baze (0,125 mg soli) dva puta dnevno, (0,176 mg baze/0,25 mg soli dnevno).
English: There is no relevant use of SIFROL prolonged-release tablets in the paediatric population for the indication of Parkinson's Disease.
Croatian: Nema relevantne primjene SIFROL tableta s produljenim oslobađanjem u pedijatrijskoj populaciji za indikaciju Parkinsonove bolesti.
English: The once daily administration of SIFROL prolonged-release tablets causes less frequent fluctuations in the pramipexole plasma concentration over 24 hours compared to the three times daily administration of pramipexole immediate release tablets.
Croatian: Jednokratna dnevna primjena SIFROL tableta s produljenim oslobađanjem rjeđe izaziva fluktuacije u koncentracijama pramipeksola u plazmi tijekom 24 sata u usporedbi s trokratnom dnevnom primjenom pramipeksol tableta s trenutnim oslobađanjem.
English: During the first week, the usual dose is 1 tablet SIFROL 0.088 mg three times a day (equivalent to 0.264 mg daily):
Croatian: Tijekom prvog tjedna, uobičajena doza je 1 tableta SIFROLA 0,088 mg tri puta dnevno (što odgovara 0,264 mg dnevno):
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).
Croatian: Obavijestite liječnika ako Vi ili Vaša obitelj / skrbnik primijetite razvoj manije (agitacija, osjećaj ushita ili pretjeranog uzbuđenja) ili delirija (poremećaj svijesti, konfuzija, gubitak osjećaja za stvarnost).
English: If you have moderate kidney disease, the usual starting dose is 1 tablet SIFROL 0.088 mg twice a day.
Croatian: Ako imate umjerenu bolest bubrega, uobičajena početna doza je 1 tableta SIFROLA 0,088 mg dvaput dnevno.
English: The recommended starting dose of SIFROL is 0.088 mg of base (0.125 mg of salt) taken once daily 2-3 hours before bedtime.
Croatian: Preporučena početna doza SIFROLA je 0,088 mg baze (0,125 mg soli) jedanput dnevno 2-3 sata prije spavanja.
English: Take your SIFROL (immediate release) tablets as normal the day before you switch.
Croatian: Uzmite SIFROL tablete (s trenutnim oslobađanjem) po uobičajenom rasporedu dan prije prijelaza na drugu terapiju.
English: All strengths of SIFROL are available in aluminium blister strips of 10 tablets per strip, in cartons containing 3 or 10 blister strips (30 or 100 tablets).
Croatian: Sve jačine lijeka SIFROL dostupne su u aluminijskim blisterima s 10 tableta, u kutijama s 3 ili 10 blistera (30 ili 100 tableta).
English: During the first week, the usual dose is 1 tablet SIFROL 0.088 mg once a day (equivalent to 0.088 mg daily):
Croatian: Tijekom prvog tjedna, uobičajena doza je 1 tableta SIFROL 0,088 mg jedanput dnevno (što odgovara 0,088 mg dnevno):
English: How to store SIFROL
Croatian: Kako čuvati SIFROL
English: When SIFROL is given in combination with levodopa, it is recommended that the dose of levodopa is reduced and the dose of other anti-parkinsonian medicinal products is kept constant while increasing the dose of SIFROL.
Croatian: Kada se SIFROL primjenjuje u kombinaciji s levodopom, preporučuje se sniziti dozu levodope i ne mijenjati doze ostalih antiparkinsonika, dok se povisuje doza SIFROLA.
English: What SIFROL looks like and contents of the pack SIFROL 0.088 mg tablets are white, of round shape, flat, and without scoring.
Croatian: Kako SIFROL izgleda i sadržaj pakiranja SIFROL 0,088 mg tablete su bijele, okruglog oblika, plosnate, bez razdjelne crte.
English: All strengths of SIFROL are available in aluminium blister strips of 10 tablets per strip, in cartons containing 1, 3 or 10 blister strips (10, 30 or 100 prolonged-release tablets).
Croatian: Sve jačine lijeka SIFROL dostupne su u aluminijskim blisterima s 10 tableta, u kutijama s 1, 3, ili 10 blistera (10, 30 ili 100 tableta s produljenim oslobađanjem).
English: SIFROL 0.7 mg tablets are white, of round shape, and flat.
Croatian: SIFROL 0,7 mg tablete su bijele, okruglog oblika, plosnate.
English: 1 tablet SIFROL 0.7 mg and 1 tablet SIFROL 0.35 mg three times a day
Croatian: 1 tableta SIFROL 0,7 mg i 1 tableta SIFROL 0,35 mg tri puta dnevno
English: In severe kidney disease, the usual starting dose is just 1 tablet SIFROL 0.088 mg a day.
Croatian: Kod teške bolesti bubrega, uobičajena početna doza je samo 1 tableta SIFROL 0,088 mg dnevno.
English: In patients with a creatinine clearance less than 20 ml/min, the daily dose of SIFROL should be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily.
Croatian: U bolesnika s klirensom kreatinina manjim od 20 ml/min, SIFROL je potrebno primijeniti u jednokratnoj dozi, počevši od 0,088 mg baze (0,125 mg soli) dnevno.
English: Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with SIFROL.
Croatian: Tijekom liječenja SIFROLOM bolesnici moraju biti informirani o tome, te ih se mora upozoriti na povećan oprez pri upravljanju motornim vozilima ili strojevima.
English: Common: - Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness - Tiredness (fatigue) - Headache - Abnormal dreams - Constipation - Dizziness - Vomiting (being sick)
Croatian: Često: - promjene u obrascu spavanja, kao što su nesanica i pospanost - umor - glavobolja - neobični snovi - zatvor - omaglica - povraćanje
English: If you are switching from SIFROL (immediate release) tablets Your doctor will base your dose of SIFROL prolonged-release tablets on the dose of SIFROL (immediate release) tablets you were taking.
Croatian: Liječnik će započeti s dozom SIFROL tableta s produljenim oslobađanjem adekvatno Vašoj dozi SIFROL tableta (s trenutnim oslobađanjem) koju ste uzimali.
English: Ascending dose schedule of SIFROL prolonged-release tablets Week Daily dose (mg of base)
Croatian: Raspored doziranja SIFROLA Titracijski korak Večernja doza jedanput dnevno (mg baze)
English: Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly with SIFROL.
Croatian: Potrebno je razmotriti mogućnost sniženja doze pramipeksola u slučaju primjene navedenih lijekova u kombinaciji sa SIFROLOM.
English: If you have advanced Parkinson's disease and are also taking levodopa, you might develop dyskinesia during the uptitration of SIFROL.
Croatian: Ako imate uznapredovalu Parkinsonovu bolest te također uzimate levodopu, može doći do razvoja diskinezije tijekom povećavanja doze SIFROLA.
English: SIFROL 0.18 mg tablets and SIFROL 0.35 mg tablets are white, of oval shape, and flat.
Croatian: SIFROL 0,18 mg tablete i SIFROL 0,35 mg tablete su bijele, ovalnog oblika, plosnate.
English: Parkinson's disease and are also taking levodopa, you might develop dyskinesia during the up titration of SIFROL.
Croatian: Parkinsonovu bolest te također uzimate levodopu, može doći do razvoja diskinezije tijekom povećavanja doze SIFROLA.
English: A lower maintenance dose of one SIFROL 0.26 mg prolonged-release tablet a day is also possible.
Croatian: Također je moguća niža doza održavanja od jedne SIFROL 0,26 mg tablete s produljenim oslobađanjem dnevno.
English: 1 tablet SIFROL 0.35 mg and 1 tablet SIFROL 0.18 mg
Croatian: 1 tableta SIFROL 0,35 mg i 1 tableta SIFROL 0,18 mg
English: SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets
Croatian: SIFROL 0,088 mg tablete SIFROL 0,18 mg tablete SIFROL 0,35 mg tablete SIFROL 0,7 mg tablete
English: SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets Pramipexole
Croatian: SIFROL 0,088 mg tablete SIFROL 0,18 mg tablete SIFROL 0,35 mg tablete SIFROL 0,7 mg tablete pramipeksol
English: - Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs) - Hyperkinesia (increased movements and inability to keep still)* - Paranoia (e.g. excessive fear for one's own well-being)* - Delusion* - Amnesia (memory disturbance)* - 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:
Croatian: - zatajenje srca (problemi sa srcem koji mogu izazvati nedostatak zraka i otečenost gležnjeva)* - neodgovarajuće lučenje antidiuretskog hormona* - diskinezija (npr. abnormalni, nekontrolirani pokreti udova) - hiperkinezija (učestali pokreti i nesposobnost ostajanja u mirnom položaju)* - paranoja (npr. pretjeran strah za vlastitu dobrobit)* - zablude (deluzije)* - amnezija (poremećaj pamćenja)* - halucinacije (vidjeti, čuti ili osjećati stvari koje nisu prisutne) - smetenost - prekomjerna dnevna pospanost i iznenadno usnivanje - porast tjelesne težine - hipotenzija (niski krvni tlak) - prekomjerno nakupljanje tekućine, obično u nogama (periferni edem) - alergijske reakcije (npr. osip, svrbež, preosjetljivost) - nesvjestica - nemir - poremećaj vida - gubitak težine uključujući smanjeni apetit - zaduha (otežano disanje) - štucanje - upala pluća (infekcija pluća)* - Nemogućnost odupiranja nagonu, porivu ili iskušenju za vršenje radnji koje bi mogle naškoditi
English: SIFROL 0.26 mg prolonged-release tablets SIFROL 0.52 mg prolonged-release tablets SIFROL 1.05 mg prolonged-release tablets SIFROL 1.57 mg prolonged-release tablets SIFROL 2.1 mg prolonged-release tablets SIFROL 2.62 mg prolonged-release tablets SIFROL 3.15 mg prolonged-release tablets
Croatian: SIFROL 0,26 mg tablete s produljenim oslobađanjem SIFROL 0,52 mg tablete s produljenim oslobađanjem SIFROL 1,05 mg tablete s produljenim oslobađanjem SIFROL 1,57 mg tablete s produljenim oslobađanjem SIFROL 2,1 mg tablete s produljenim oslobađanjem SIFROL 2,62 mg tablete s produljenim oslobađanjem SIFROL 3,15 mg tablete s produljenim oslobađanjem
English: Not known: - After stopping or reducing your SIFROL treatment: Depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).
Croatian: Nepoznato: - Nakon prestanka liječenja ili sniženja doze lijeka SIFROL: mogu se javiti depresija, apatija,
English: SIFROL 0.35 mg tablets EU/1/97/050/011-012
Croatian: SIFROL 0,35 mg tablete EU/1/97/050/011-012
English: 2 tablets SIFROL 0.18 mg three times a day
Croatian: 2 tablete SIFROLA 0,18 mg tri puta dnevno
English: SIFROL with food, drink and alcohol You should be cautious while drinking alcohol during treatment with SIFROL.
Croatian: Potreban je oprez prilikom konzumacije alkohola tijekom liječenja SIFROLOM.
English: SIFROL 0.35 mg tablets
Croatian: SIFROL 0,35 mg tablete
English: SIFROL 0.088 mg tablets
Croatian: SIFROL 0,088 mg tablete
English: 1 tablet SIFROL 0.35 mg three times a day OR
Croatian: 1 tableta SIFROLA 0,35 mg tri puta dnevno ILI
English: SIFROL 2.62 mg prolonged-release tablets EU/1/97/050/031-033
Croatian: SIFROL 2,62 mg tablete s produljenim oslobađanjem EU/1/97/050/031-033
English: SIFROL 0.7 mg tablets EU/1/97/050/005-006
Croatian: SIFROL 0,7 mg tablete EU/1/97/050/005-006
English: 1 tablet SIFROL 0.35 mg OR
Croatian: 1 tableta SIFROL 0,35 mg
English: SIFROL 0.52 mg prolonged-release tablets EU/1/97/050/016-018
Croatian: SIFROL 0,52 mg tablete s produljenim oslobađanjem EU/1/97/050/016-018
English: SIFROL 0.7 mg tablets
Croatian: SIFROL 0,7 mg tablete
English: SIFROL 0.088 mg tablets EU/1/97/050/001-002
Croatian: SIFROL 0,088 mg tablete EU/1/97/050/001-002
English: SIFROL 0.18 mg tablets
Croatian: SIFROL 0,18 mg tablete
English: SIFROL 0.18 mg tablets EU/1/97/050/003-004
Croatian: SIFROL 0,18 mg tablete EU/1/97/050/003-004
English: INFORMATION IN BRAILLE SIFROL 0.088 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU SIFROL 0,088 mg
English: 2 tablets SIFROL 0.088 mg three times a day
Croatian: 2 tablete SIFROLA 0,088 mg tri puta dnevno
English: INFORMATION IN BRAILLE SIFROL 0.35 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU SIFROL 0,35 mg
English: 1 tablet SIFROL 0.18 mg three times a day OR
Croatian: 1 tableta SIFROLA 0,18 mg tri puta dnevno ILI
English: INFORMATION IN BRAILLE SIFROL 0.18 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU SIFROL 0,18 mg
English: 1 tablet SIFROL 0.088 mg three times a day
Croatian: 1 tableta SIFROL 0,088 mg tri puta dnevno
English: INFORMATION IN BRAILLE SIFROL 0.7 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU SIFROL 0,7 mg
English: SIFROL 2.62 mg prolonged-release tablets
Croatian: SIFROL 2,62 mg tablete s produljenim oslobađanjem
English: What SIFROL looks like and contents of the pack SIFROL 0.26 mg and 0.52 mg prolonged-release tablets are white to off-white, of round shape, and have bevelled edges.
Croatian: SIFROL 0,26 mg i 0,52 mg tablete s produljenim oslobađanjem su bijele do gotovo bijele boje, okruglog oblika, te imaju kose rubove.
English: SIFROL 1.05 mg prolonged-release tablets EU/1/97/050/019-021
Croatian: SIFROL 1,05 mg tablete s produljenim oslobađanjem EU/1/97/050/019-021
English: SIFROL 2.1 mg prolonged-release tablets EU/1/97/050/022-024
Croatian: SIFROL 2,1 mg tablete s produljenim oslobađanjem EU/1/97/050/022-024
English: NAME OF THE MEDICINAL PRODUCT SIFROL 0.088 mg tablets Pramipexole
Croatian: NAZIV LIJEKA SIFROL 0,088 mg tablete pramipeksol
English: SIFROL 1.57 mg prolonged-release tablets EU/1/97/050/028-030
Croatian: SIFROL 1,57 mg tablete s produljenim oslobađanjem EU/1/97/050/028-030
English: SIFROL 0.52 mg prolonged-release tablets
Croatian: SIFROL 0,52 mg tablete s produljenim oslobađanjem
English: SIFROL 3.15 mg prolonged-release tablets EU/1/97/050/025-027
Croatian: SIFROL 3,15 mg tablete s produljenim oslobađanjem EU/1/97/050/025-027
English: In advanced Parkinson's disease, in combination treatment with levodopa, dyskinesia can occur during the initial titration of SIFROL.
Croatian: Tijekom početne titracije SIFROLA kod uznapredovale Parkinsonove bolesti, može doći do pojava diskinezije kod bolesnika liječenih kombinacijom pramipeksola i levodope.
English: 2 tablets SIFROL 0.18 mg OR
Croatian: 2 tablete SIFROL 0,18 mg
English: 1 tablet SIFROL 0.088 mg
Croatian: 1 tableta SIFROL 0,088 mg
English: 3 tablets SIFROL 0.18 mg OR
Croatian: 3 tablete SIFROL 0,18 mg
English: SIFROL 3.15 mg prolonged-release tablets
Croatian: SIFROL 3,15 mg tablete s produljenim oslobađanjem
English: INFORMATION IN BRAILLE SIFROL 2.62 mg prolonged-release tablets 17.
Croatian: 16. PODACI NA BRAILLEOVOM PISMU SIFROL 2,62 mg tablete s produljenim oslobađanjem
English: 4 tablets SIFROL 0.088 mg
Croatian: 4 tablete SIFROL 0,088 mg
English: SIFROL 1.05 mg prolonged-release tablets
Croatian: SIFROL 1,05 mg tablete s produljenim oslobađanjem
English: SIFROL 1.57 mg prolonged-release tablets
Croatian: SIFROL 1,57 mg tablete s produljenim oslobađanjem
English: SIFROL 0.26 mg prolonged-release tablets
Croatian: SIFROL 0,26 mg tablete s produljenim oslobađanjem
English: 6 tablets SIFROL 0.088 mg
Croatian: 6 tableta SIFROL 0,088 mg
English: INFORMATION IN BRAILLE SIFROL 0.26 mg prolonged-release tablets 17.
Croatian: 16. PODACI NA BRAILLEOVOM PISMU SIFROL 0,26 mg tablete s produljenim oslobađanjem
English: INFORMATION IN BRAILLE SIFROL 0.52 mg prolonged-release tablets 17.
Croatian: 16. PODACI NA BRAILLEOVOM PISMU SIFROL 0,52 mg tablete s produljenim oslobađanjem
English: EU/1/97/050/004 [100 tablets]
Croatian: EU/1/97/050/004 [100 tableta]
English: NAME OF THE MEDICINAL PRODUCT SIFROL 0.18 mg tablets Pramipexole
Croatian: NAZIV LIJEKA SIFROL 0,18 mg tablete pramipeksol
English: INFORMATION IN BRAILLE SIFROL 1.57 mg prolonged-release tablets 17.
Croatian: 16. PODACI NA BRAILLEOVOM PISMU SIFROL 1,57 mg tablete s produljenim oslobađanjem
English: EU/1/97/050/012 [100 tablets]
Croatian: EU/1/97/050/012 [100 tableta]
English: SIFROL 2.1 mg prolonged-release tablets
Croatian: SIFROL 2,1 mg tablete s produljenim oslobađanjem
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/011 [30 tablets]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/97/050/011 [30 tableta]
English: INFORMATION IN BRAILLE SIFROL 1.05 mg prolonged-release tablets 17.
Croatian: 16. PODACI NA BRAILLEOVOM PISMU SIFROL 1,05 mg tablete s produljenim oslobađanjem
English: Each prolonged-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.26 mg pramipexole.
Croatian: Jedna tableta s produljenim oslobađanjem sadrži 0,375 mg pramipeksoldiklorid hidrata što odgovara 0,26 mg pramipeksola.
English: INFORMATION IN BRAILLE SIFROL 3.15 mg prolonged-release tablets 17.
Croatian: 16. PODACI NA BRAILLEOVOM PISMU SIFROL 3,15 mg tablete s produljenim oslobađanjem
English: EU/1/97/050/002 [100 tablets]
Croatian: EU/1/97/050/002 [100 tableta]
English: NAME OF THE MEDICINAL PRODUCT SIFROL 0.35 mg tablets Pramipexole
Croatian: NAZIV LIJEKA SIFROL 0,35 mg tablete pramipeksol
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/016 [10 prolonged-release tablets] EU/1/97/050/017 [30 prolonged-release tablets] EU/1/97/050/018 [100 prolonged-release tablets]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/97/050/016 [10 tableta s produljenim oslobađanjem] EU/1/97/050/017 [30 tableta s produljenim oslobađanjem] EU/1/97/050/018 [100 tableta s produljenim oslobađanjem]
English: Ascending dose schedule of SIFROL prolonged-release tablets Week Daily dose (mg) Number of tablets One SIFROL 0.26 mg prolonged-release tablet.
Croatian: Režim doziranja SIFROL tableta s produljenim oslobađanjem Tjedan Dnevna doza (mg) Broj tableta Jedna SIFROL 0,26 mg tableta s produljenim oslobađanjem Jedna SIFROL 0,52 mg tableta s produljenim oslobađanjem ILI dvije SIFROL 0,26 mg tablete s produljenim oslobađanjem Jedna SIFROL 1,05 mg tableta s produljenim oslobađanjem ILI dvije SIFROL 0,52 mg tablete s produljenim oslobađanjem ILI četiri SIFROL 0,26 tablete s produljenim oslobađanjem.
English: NAME OF THE MEDICINAL PRODUCT SIFROL 0.7 mg tablets Pramipexole
Croatian: NAZIV LIJEKA SIFROL 0,7 mg tablete pramipeksol
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/025 [10 prolonged-release tablets] EU/1/97/050/026 [30 prolonged-release tablets] EU/1/97/050/027 [100 prolonged-release tablets]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/97/050/025 [10 tableta s produljenim oslobađanjem] EU/1/97/050/026 [30 tableta s produljenim oslobađanjem] EU/1/97/050/027 [100 tableta s produljenim oslobađanjem]
English: EU/1/97/050/006 [100 tablets]
Croatian: EU/1/97/050/006 [100 tableta]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/031 [10 prolonged-release tablets] EU/1/97/050/032 [30 prolonged-release tablets] EU/1/97/050/033 [100 prolonged-release tablets]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/97/050/031 [10 tableta s produljenim oslobađanjem] EU/1/97/050/032 [30 tableta s produljenim oslobađanjem] EU/1/97/050/033 [100 tableta s produljenim oslobađanjem]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/013 [10 prolonged-release tablets] EU/1/97/050/014 [30 prolonged-release tablets] EU/1/97/050/015 [100 prolonged-release tablets]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/97/050/013 [10 tableta s produljenim oslobađanjem] EU/1/97/050/014 [30 tableta s produljenim oslobađanjem] EU/1/97/050/015 [100 tableta s produljenim oslobađanjem]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/028 [10 prolonged-release tablets] EU/1/97/050/029 [30 prolonged-release tablets] EU/1/97/050/030 [100 prolonged-release tablets]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/97/050/028 [10 tableta s produljenim oslobađanjem] EU/1/97/050/029 [30 tableta s produljenim oslobađanjem] EU/1/97/050/030 [100 tableta s produljenim oslobađanjem]
English: MARKETING AUTHORISATION NUMBER(S) SIFROL 0.26 mg prolonged-release tablets EU/1/97/050/013-015
Croatian: SIFROL 0,26 mg tablete s produljenim oslobađanjem EU/1/97/050/013-015