FrancophonIA/ELRC3.0 huggingface dataset:
English: The tablet can be divided into equal halves.
Croatian: Tableta se može razdijeliti na jednake polovice.
English: In open continuation trials lasting for more than three years there were no signs of decreasing efficacy.
Croatian: Također, u otvorenim produženim studijama u trajanju preko 3 godine, nije bilo znakova smanjenja djelotvornosti.
English: The absolute bioavailability is greater than 90 % and the maximum plasma concentrations occur between 1 and 3 hours.
Croatian: Apsolutna bioraspoloživost je veća od 90%, a maksimalne koncentracije u plazmi postižu se za 1-3 sata.
English: Frequency cannot be estimated from the available data
Croatian: Nepoznato učestalost se ne može procijeniti iz dostupnih podataka
English: Swallow the tablets with water.
Croatian: Progutajte tablete s vodom.
English: Take care if you are using any medicines that calm you down (have a sedative effect) or if you are drinking alcohol.
Croatian: Budite oprezni ako uzimate bilo kakve lijekove za smirenje (sa sedativnim učinkom) ili ako pijete alkohol.
English: Augmentation was specifically investigated in a controlled clinical trial over 26 weeks.
Croatian: Augmentacija je bila specifično proučavana u kontroliranim kliničkim ispitivanjima u trajanju od preko 26 tjedana.
English: The doctor will advise you on the right dosing.
Croatian: Liječnik će Vam preporučiti pravilnu dozu.
English: Augmentation refers to the earlier onset of symptoms in the evening (or even the afternoon), increase in symptoms, and spread of symptoms to involve other extremities.
Croatian: Augmentacija se odnosi na raniji nastup večernjih simptoma (ili čak poslijepodne), povećanje simptoma, i širenje simptoma na druge ekstremitete.
English: Your doctor will review your treatment after 3 months to decide whether or not to continue the treatment.
Croatian: Liječnik će revidirati Vaše liječenje nakon 3 mjeseca kako bi odlučio treba li ili ne nastaviti s liječenjem.
English: It can be used alone or in combination with levodopa (another medicine for Parkinson's disease).
Croatian: Može se koristiti sam ili u kombinaciji s levodopom (još jedan lijeka za liječenje Parkinsonove bolesti).
English: You can then build up the dose again, as you did the first time.
Croatian: Zatim možete doći do Vaše prethodno uzimane doze, kako ste učinili i prvi puta.
English: In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma.
Croatian: U štakorica, koncentracija radioaktivne djelatne tvari bila je veća u mlijeku nego u plazmi.
English: With 95 % certainty, the frequency category is not greater than uncommon, but might be lower.
Croatian: S 95 % sigurnosti, učestalost nije veća od kategorije manje često, a može biti i manja.
English: Also, it can pass into the breast milk and can reach your baby.
Croatian: Lijek se također može izlučiti u majčino mlijeko i može doći do Vašeg djeteta.
English: If you have to stop taking this medicine, your doctor will reduce the dose gradually.
Croatian: Ako morate prestati uzimati ovaj lijek, Vaš će liječnik postepeno smanjivati dozu.
English: Patients should be informed that (mostly visual) hallucinations can occur.
Croatian: Bolesnici trebaju biti informirani o mogućnosti pojave halucinacija (uglavnom vizualnih).
English: • Strong impulse to gamble excessively despite serious personal or family consequences.
Croatian: • snažan nagon za pretjeranim kockanjem usprkos teškim posljedicama za osobu ili obitelj.*
English: The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
Croatian: Potencijalni učinak pramipeksola na reproduktivnu funkciju istraživan je na štakorima i zečevima.
English: As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
Croatian: Kako se antikolinergici uglavnom eliminiraju biotransformacijom, mogućnost pojave interakcije je ograničena, iako interakcija s antikolinergicima nije istraživana.
English: The frequency category is probably not greater than “uncommon”.
Croatian: Kategorija učestalosti vjerojatno nije veća od „manje često“.
English: Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following:
Croatian: Recite svom liječniku ako imate (ili ste imali) ili razvijete bilo kakva stanja ili simptome, osobito neke od sljedećih:
English: The usual maintenance dose is 1.1 mg per day.
Croatian: Uobičajena doza održavanja je 1,1 mg dnevno.
English: Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements.
Croatian: Stimulacija dopamisnkih receptora potiče živčane impulse u mozgu što pomaže u kontroli pokreta tijela.
English: The effect on pregnancy and lactation has not been investigated in humans.
Croatian: Učinak na trudnoću i dojenje nije istraživan kod ljudi.
English: Such effect was not observed in patient studies.
Croatian: Takav učinak nije zamijećen u ispitivanjima na bolesnicima.
English: A delay in sexual development (i.e., preputial separation and vaginal opening) was observed in rats.
Croatian: Odgođeni spolni razvoj (tj. prepucijsko odvajanje i vaginalno otvaranje) primijećen je na štakorima.
English: In case of severe cardiovascular disease, care should be taken.
Croatian: U slučaju teških kardiovaskularnih bolesti, potreban je poseban oprez.
English: You may experience that symptoms start earlier than usual, be more intense and involve other limbs.
Croatian: Mogli biste primjetiti da simptomi počinju ranije nego inače, da su intenzivniji i uključuju druge udove.
English: • Uncontrollable excessive shopping or spending
Croatian: - nekontrolirana prekomjerna kupnja ili trošenje
English: Kaplan-Meier analysis of time to augmentation showed no significant difference between pramipexole and placebo groups.
Croatian: Kaplan-Meierova analiza vremena do augmentacije pokazala nije značajne razlike između pramipeksola i placeba.
English: If the problems persist more than a few weeks, your doctor may need to adjust your treatment.
Croatian: Ako tegobe uporno traju dulje od nekoliko tjedana, liječnik će Vam možda trebati prilagoditi liječenje.
English: This includes medicines, herbal remedies, health foods or supplements that you have obtained without a prescription.
Croatian: To uključuje lijekove, biljne preparate, zdravu hranu ili dodatke koje ste kupili bez recepta.
English: Plasma protein binding
Croatian: Vezanje na proteine plazme
English: • Weight loss including decreased appetite
Croatian: • gubitak težine uključujući smanjeni apetit
English: • amantadine (which can be used to treat Parkinson's disease)
Croatian: • amantadin (koji se može koristiti za liječenje Parkinsonove bolesti)
English: Clinical efficacy and safety in Parkinson's disease
Croatian: Klinička djelotvornost i sigurnost kod Parkinsonove bolesti
English: • Contact your doctor or nearest hospital casualty department immediately for advice.
Croatian: • Obratite se odmah svome liječniku ili na hitni prijem u najbližoj bolnici za savjet.
English: Hallucinations or somnolence can occur.
Croatian: Može doći do pojave halucinacija ili somnolencije.
English: • treat the symptoms of primary Parkinson's disease in adults.
Croatian: • liječenju simptoma primarne Parkinsonove bolesti u odraslih.
English: • Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
Croatian: • Nemogućnost odupiranja nagonu, porivu ili iskušenju za vršenje radnji koje bi mogle naškoditi Vama ili drugima, što može uključivati:
English: You will need to have your blood pressure checked regularly, especially at the beginning of treatment.
Croatian: Trebali biste redovito kontrolirati krvni tlak, osobito na početku liječenja.
English: This is to avoid postural hypotension (a fall in blood pressure on standing up).
Croatian: To je zato da se izbjegne posturalna hipotenzija (pad krvnog tlaka kod ustajanja).
English: If you stop taking your tablets for more than a few days and want to restart the treatment, you must start again at the lowest dose.
Croatian: Ako prestanete uzimati tablete na dulje od nekoliko dana te želite ponovno početi liječenje, morate opet početi s najnižom dozom.
English: The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
Croatian: To nije primijećeno u pigmentiranih štakora, niti u ispitivanjima karcinogenosti 2-godišnjih albino miševa, a niti u drugim ispitivanim životinjskim vrstama.
English: The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
Croatian: Poluvrijeme eliminacije (t1/2) varira od 8 sati kod mladih sve do 12 sati kod starijih osoba.
English: Combination with levodopa
Croatian: Kombinacija s levodopom
English: Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
Croatian: Stoga se ne očekuje interakcija s drugim lijekovima koji imaju utjecaj na vezanje za proteine plazme ili eliminaciju putem biotransformacije.
English: The following dose schedule is suggested for initiation of therapy:
Croatian: Preporučuje se sljedeća shema doza u početku terapije:
English: • Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)*
Croatian: • prejedanje (jedenje ogromnih količina hrane u kratkom razdoblju) ili kompulzivno jedenje (izjedanje veće količine hrane nego što je normalno i više nego je potrebno za utaženje gladi)*
English: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Croatian: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex,
English: Blisters:
Croatian: Blisteri:
English: 1 This side effect has been observed in post-marketing experience.
Croatian: 1 Ova nuspojava je zabilježena u postmarketinškom praćenju.
English: Your doctor will then discuss with you if you should continue to take Pramipexole Teva.
Croatian: Vaš liječnik će razgovarati s Vama trebate li nastaviti uzimati Pramipeksol Teva.
English: Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.
Croatian: Bolesnici koji su doživjeli somnolenciju i/ili epizodu iznenadnog usnivanja ne smiju upravljati motornim vozilima niti strojevima.
English: Augmentation
Croatian: Augmentacija
English: Talk to your doctor before taking Pramipexole Teva.
Croatian: Obratite se svom liječniku prije nego uzmete Pramipeksol Teva.
English: What Pramipexole Teva is and what it is used for
Croatian: Što je Pramipeksol Teva i za što se koristi
English: Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Croatian: U klasifikaciji prema organskim sustavima, nuspojave su navedene prema učestalosti (broj bolesnika kod kojih se očekuje nuspojava), uz uporabu sljedećih kategorija: vrlo često (≥1/10), često (≥1/100 do <1/10), manje često (≥1/1 000 do <1/100), rijetko (≥1/10 000 do <1/1 000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Pharmacotherapeutic group: anti-Parkinson drugs, dopamine agonists, ATC code: N04BC05
Croatian: Farmakoterapijska skupina: antiparkinsonici, agonisti dopamina, ATK oznaka: N04BC05.
English: Parkinson's disease
Croatian: Parkinsonova bolest
English: You should avoid taking Pramipexole Teva together with antipsychotic medicines.
Croatian: Trebali biste izbjegavati uzimanje lijeka Pramipeksol Teva zajedno s antipsihotičkim lijekovima.
English: If you have moderate or severe kidney disease, your doctor will prescribe a lower dose.
Croatian: Ako imate umjerenu ili tešku bolest bubrega, liječnik će Vam propisati nižu dozu.
English: The relevance for humans is unknown.
Croatian: Nije poznat značaj za ljude.
English: In humans, the protein binding of pramipexole is very low (< 20 %) and the volume of distribution is large (400 l).
Croatian: U ljudi, vezanje pramipeksola na proteine plazme je vrlo nisko (<20%), a volumen distribucije je vrlo velik (400 l).
English: The same study also showed that, at doses of 2 mg/kg (of salt) and higher, pramipexole was associated with retinal degeneration in albino rats.
Croatian: Isto ispitivanje je također pokazalo da je u dozama od 2 mg/kg (soli) i višim, pramipeksol povezan s retinalnom degeneracijom u albino štakora.
English: Renal excretion of unchanged pramipexole is the major route of elimination.
Croatian: Bubrežna ekskrecija nepromijenjenog pramipeksola je glavni put eliminacije lijeka.
English: Pramipexole Teva should not be used during pregnancy unless clearly necessary, i.e. if the potential benefit justifies the potential risk to the foetus.
Croatian: Teva se ne smije primjenjivati tijekom trudnoće osim ako je nužno potreban, tj. ako očekivana korist opravdava potencijalni rizik za fetus.
English: • Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.
Croatian: • promijenjeno ili povećano zanimanje za seksom i ponašanje koje znatno zabrinjava Vas ili druge, na primjer, povećani spolni nagon.*
English: • quinine (which can be used for the prevention of painful night-time leg cramps and for the treatment of a type of malaria known as falciparum malaria (malignant malaria))
Croatian: • kinin (koji se može koristiti za prevenciju bolnih noćnih grčeva u nogama i za liječenje vrste malarije poznate kao falciparum malarija (zloćudna malarija))
English: Lowest maintenance dose Highest maintenance dose
Croatian: Najniža doza održavanja
English: It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of postural hypotension associated with dopaminergic therapy.
Croatian: Preporučuje se kontroliranje krvnog tlaka, posebno na početku liječenja, zbog opasnosti od nastanka posturalne hipotenzije povezane s dopaminergičkom terapijom.
English: However, there was no significant difference during the maintenance phase.
Croatian: Međutim, tijekom primjene doze održavanja stanja, nije bilo značajnih razlika.
English: • Hypotension (low blood pressure)
Croatian: • hipotenzija (niski krvni tlak)
English: Providing patients do not experience intolerable undesirable effects, the dose should be titrated to achieve a maximal therapeutic effect.
Croatian: Pod pretpostavkom da bolesnici nemaju nepodnošljive nuspojave, dozu je potrebno titrirati do postizanja maksimalnog terapijskog učinka.
English: If treatment is interrupted for more than a few days it should be re-initiated by dose titration carried out as above.
Croatian: Ako se liječenje prekida na više od nekoliko dana, potrebno ga je ponovo započeti s titracijom doza kao što je prethodno navedeno.
English: behavioural symptoms of impulse control disorders and compulsions1 (such as:
Croatian: bihevioralni simptomi u vidu poremećaja kontrole nagona i kompulzije1 (kao što je:
English: • cisplatin (to treat various types of cancers)
Croatian: • cisplatin (za liječenje nekoliko vrsta raka)
English: Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
Croatian: Bolesnike s psihotičnim poremećajima smije se liječiti agonistima dopamina samo ako je očekivana korist veća od rizika takvog liječenja.
English: There is no pharmacokinetic interaction with selegiline and levodopa.
Croatian: Ne postoji farmakokinetička interakcija sa selegilinom i levodopom.
English: Patients should be informed about this before tapering the dopamine agonist, and monitored regularly thereafter.
Croatian: Bolesnike je o tome potrebno obavijestiti prije snižavanja doze agonista dopamina te ih redovito pratiti.
English: Neuroleptic malignant syndrome
Croatian: Maligni neuroleptički sindrom
English: The daily dose is administered in equally divided doses 3 times a day.
Croatian: Dnevna doza primjenjuje se podijeljena u jednake doze 3 puta dnevno.
English: Although dystonia may be a symptom of Parkinson's disease, the symptoms in these patients have improved after reduction or withdrawal of pramipexole.
Croatian: Iako distonija može biti simptom Parkinsonove bolesti, simptomi u tih bolesnika poboljšali su se nakon smanjenja ili povlačenja pramipeksola.
English: Table 1: Parkinson's disease
Croatian: Tablica 1: Parkinsonova bolest
English: Evaluation of these side effects is based on the following frequencies:
Croatian: Ocjena ovih nuspojava zasniva se na sljedećim učestalostima:
English: • Urge to behave in an unusual way*
Croatian: • potreba za neuobičajenim ponašanjem*
English: The adjusted mean difference was -4.3 points (CI 95% -6.4; -2.1 points, p-value <0.0001).
Croatian: Prilagođena prosječna razlika bila je -4,3 boda (CI 95%-6,4; -2,1 boda, p-vrijednost <0,0001).
English: Other medicines and Pramipexole Teva
Croatian: Drugi lijekovi i Pramipeksol Teva
English: GALIEN LPS 98 rue Bellocier 89100 Sens France
Croatian: GALIEN LPS 98 rue Bellocier 89100 Sens Francuska
English: • Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness
Croatian: • promjene u obrascu spavanja, kao što su nesanica i pospanost
English: Out of these, approximately 1,000 were in more advanced stages, received concomitant levodopa therapy, and suffered from motor complications.
Croatian: Njih oko 1000 bili su u uznapredovalim stadijima bolesti, istodobno su dobivali terapiju levodopom te su imali motoričke komplikacije.
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake „EXP“.
English: Your doctor may need to adjust or stop your dose.
Croatian: Liječnik će možda morati prilagoditi ili ukinuti Vašu dozu.
English: • Inappropriate antidiuretic hormone secretion*
Croatian: • neodgovarajuće lučenje antidiuretskog hormona*
English: Merckle GmbH Ludwig-Merckle-Straße 3 89143 Blaubeuren Germany
Croatian: Merckle GmbH Ludwig-Merckle-Straße 3 89143 Blaubeuren
English: 63 % of patients on pramipexole and 52 % of patients on placebo reported at least one adverse drug reaction.
Croatian: 63% bolesnika na pramipeksolu i 52% bolesnika na placebu prijavilo je najmanje jednu nuspojavu.
English: This will be increased every 5-7 days as directed by your doctor until your symptoms are controlled (maintenance dose).
Croatian: Ova doza će se povećavati svakih 5-7 dana prema uputi Vašeg liječnika, sve dok Vaši simptomi ne budu pod kontrolom (doza održavanja).
English: Due to the selection of animal species and the limited parameters investigated, the adverse effects of pramipexole on pregnancy and male fertility have not been fully elucidated.
Croatian: Zbog selekcije životinjskih vrsta i ograničenosti istraživanih parametara nema konačnog zaključka o nuspojavama pramipeksola na trudnoću i mušku plodnost.
English: However, if its use is unavoidable, breast-feeding should be discontinued.
Croatian: Međutim, ako je njegova primjena neizbježna, potrebno je prestati s dojenjem.
English: Patients should be regularly monitored for the development of mania and delirium.
Croatian: Bolesnike je potrebno redovito pratiti radi mogućnosti razvoja manije i delirija.
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 or 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 ili gubitak osjećaja za stvarnost).
English: A sudden stop could cause you to develop a medical condition called neuroleptic malignant syndrome which may represent a major health risk.
Croatian: Nagli prekid mogao bi uzrokovati razvoj medicinskog stanja koje se zove neuroleptički maligni sindrom koji može predstavljati veliku opasnost za zdravlje.
English: There is no clinical experience with massive overdose.
Croatian: Za sada nema kliničkih iskustava masovnog predoziranja.
English: Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.
Croatian: Obavijestite svog liječnika ako Vi ili vaša obitelj/skrbnici primijetite da razvijate nagone i žudnju za Vas neuobičajenim ponašanjem i ne možete odoljeti porivu ili iskušenju za određenom aktivnosti koja bi mogla naštetiti Vama ili drugima.
English: H-4042 Debrecen
Croatian: H-4042 Debrecen Mađarska
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti podnositi ako je lijek uvršten u referentni popis datuma EU (EURD popis) predviđen člankom 107(c) stavkom 7 Direktive
English: Pramipexole Teva can reduce the production of breast milk.
Croatian: Pramipeksol Teva može smanjiti stvaranje mlijeka.
English: • Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)*
Croatian: • zatajenje srca (problemi sa srcem koji mogu izazvati nedostatak zraka i otečenost gležnjeva)*
English: The tablets should be taken orally, swallowed with water, and can be taken either with or without food.
Croatian: Tablete treba uzeti kroz usta, progutati s vodom, a mogu se uzeti s hranom ili bez nje.
English: • Excess of fluid, usually in the legs (peripheral oedema)
Croatian: - prekomjerna količina tekućine, obično u nogama (periferni edem)
English: Patient's response should be evaluated after 3 months treatment and the need for treatment continuation should be reconsidered.
Croatian: Odgovor bolesnika na liječenje je potrebno ocjenjivati nakon 3 mjeseca liječenja, te razmotriti njegov nastavak.
English: Reports in the literature indicate that treatment of Restless Legs Syndrome with dopaminergic medicinal products can result in augmentation.
Croatian: Podaci u literaturi ukazuju na to da liječenje sindroma nemirnih nogu dopaminergičkim lijekovima može rezultirati augmentacijom.
English: If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
Croatian: Ukoliko su prisutni simptomi stimulacije središnjeg živčanog sustava, može biti indicirana primjena neuroleptika.
English: • Paranoia (e.g. excessive fear for one's own well-being)*
Croatian: • paranoja (npr. pretjeran strah za vlastitu dobrobit)*
English: • mexiletine (to treat irregular heartbeats, a condition known as ventricular arrhythmia)
Croatian: • meksiletin (za liječenje nepravilnog kucanja srca, stanje poznato kao ventrikularna aritmija)
English: • cimetidine (to treat excess stomach acid and stomach ulcers)
Croatian: • cimetidin (za liječenje viška želučane kiseline i ulkusa želuca)
English: Ask your doctor or pharmacist for advice before taking any medicine.
Croatian: Posavjetujte se s liječnikom ili ljekarnikom prije uzimanja svakog lijeka.
English: Inhibitors/competitors of active renal elimination pathway Cimetidine reduced the renal clearance of pramipexole by approximately 34 %, presumably by inhibition of the cationic secretory transport system of the renal tubules.
Croatian: Inhibitori/kompetitori aktivnog renalnog sustava eliminacije Cimetidin smanjuje klirens pramipeksola u bubrezima za oko 34%, vjerojatno inhibicijom kationskog sekrecijskog transportnog sustava u renalnim tubulima.