FrancophonIA/ELRC3.0 huggingface dataset:
English: What Tasmar looks like and contents of the pack Tasmar is an orange yellow to brown yellow, oval shaped, film-coated tablet.
Croatian: Tasmar je narančasto žuta do smeđe žuta, ovalna filmom obložena tableta.
English: Renal and urinary disorders Common
Croatian: Poremećaji bubrega i mokraćnog sustava često diskoloracija urina
English: EU/1/97/044/001 30 tablets EU/1/97/044/002 60 tablets
Croatian: EU/1/97/044/001 30 tableta EU/1/97/044/002 60 tableta
English: If you get any side effects talk to you doctor or pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane vrlo često anoreksija
English: What you need to know before you take Tasmar Do not take Tasmar: if you have liver disease or increased liver enzymes if you have severe involuntary movement (dyskinesia) if you have a previous history of severe symptoms of muscle stiffening, fever or mental confusion (Neuroleptic Malignant Syndrome (NMS) Symptom Complex ) and /or if you have damage of skeletal muscle tissue (non-traumatic Rhabdomyolysis) or fever (Hyperthermia).
Croatian: Nemojte uzimati Tasmar: - ako imate bolest jetre ili povišene jetrene enzime - ako imate teške nevoljne pokrete (diskineziju) - ako u povijesti bolesti imate teške simptome kočenja mišića, vrućice ili mentalne smetenosti
English: Each film-coated tablet contains 200 mg tolcapone tolcapone 200 mg
Croatian: Svaka filmom obložena tableta sadrži 200 mg tolkapona 200 mg tolkapona
English: The active substance is tolcapone (100 mg in each film- coated tablet) The other ingredients are:
Croatian: Što Tasmar sadrži - Djelatna tvar je tolkapon (100 mg u svakoj filmom obloženoj tableti)
English: When beginning and during treatment with Tasmar, your dose of Levodopa may need to be changed.
Croatian: Vaša doza levodope će se možda morati promijeniti pri početku i tijekom liječenja Tasmarom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton and bottle label, 100 film-coated tablets
Croatian: Kartonska kutija i naljepnica na bočici, 100 filmom obloženih tableta
English: Impulse control disorders* (Libido increased, hypersexuality, pathological gambling, compulsive spending or buying, binge eating, compulsive eating (see section 4.4))
Croatian: Psihijatrijski poremećaji vrlo često poremećaj spavanja prekomjerno sanjanje somnolencija konfuzija halucinacije rijetko poremećaj kontrole impulsa (povećanje libida, hiperseksualnost, patološko kockanje, kompulzivno trošenje ili kupovanje, prejedanje, kompulzivno jedenje (vidjeti dio 4.4))
English: Hepatic impairment: Because of the risk of liver injury observed during post-marketing use, Tasmar is contraindicated in patients with liver disease or increased liver enzymes.
Croatian: Oštećenje jetre: Tasmar je kontraindiciran u bolesnika s bolešću jetre ili povišenim jetrenim enzimima zbog rizika od oštećenja jetre opaženog tijekom postmarketinške primjene.
English: may affect up to 1 in 10 people
Croatian: mogu se javiti u do 1 na 10 osoba
English: Tasmar 200 mg film coated tablets
Croatian: Tasmar 200 mg filmom obložene tablete
English: Each film-coated tablet contains 100 mg tolcapone.
Croatian: Svaka filmom obložena tableta sadrži 100 mg tolkapona.
English: Each film-coated tablet contains 200 mg tolcapone.
Croatian: Svaka filmom obložena tableta sadrži 200 mg tolkapona.
English: Excipients with known effect: Each tablet contains 15 mg lactose For the full list of excipients, see section 6.1.
Croatian: Pomoćne tvari s poznatim učinkom: svaka tableta sadrži 15 mg laktoze
English: Calcium hydrogen phosphate Microcrystalline cellulose Povidone K30
Croatian: Jezgra tablete: kalcijev hidrogenfosfat celuloza, mikrokristalična povidon K30 natrijev škroboglikolat laktoza talk magnezijev stearat.
English: NMS (Neuroleptic Malignant Syndrome): Symptoms of Neuroleptic Malignant Syndrome (NMS) may occur during Tasmar treatment.
Croatian: Tijekom liječenja Tasmarom mogu se javiti simptomi neuroleptičkog malignog sindroma (NMS).
English: Each film-coated tablet contains 100 mg tolcapone
Croatian: Svaka filmom obložena tableta sadrži 100 mg tolkapona
English: Dyskinesia Dystonia Headache Dizziness
Croatian: Štetni događaji bol u abdomenu dispepsija
English: What Tasmar contains The active substance is tolcapone (200 mg in each film- coated tablet) The other ingredients are: Tablet core: Calcium hydrogen phosphate, Microcrystalline cellulose, Povidone K30, Sodium starch glycollate, Lactose monohydrate, Talc, Magnesium stearate.
Croatian: - Drugi sastojci su: Jezgra tablete: kalcijev hidrogenfosfat, mikrokristalična celuloza, povidon K30, natrijev škroboglikolat, laktoza monohidrat, talk, magnezijev stearat.
English: Tasmar 100 mg film-coated tablets
Croatian: Tasmar 100 mg filmom obložene tablete
English: What Tasmar looks like and contents of the pack Tasmar is a pale to light yellow, oval shaped, film-coated tablet.
Croatian: Tasmar je blijeda do svijetložuta, ovalna filmom obložena tableta.
English: Vomiting Constipation Xerostomia Abdominal pain Dyspepsia
Croatian: Štetni događaji kserostomija bol u abdomenu dispepsija
English: Neuroleptic Malignant Syndrome Symptom Complex Isolated cases of patients with symptoms suggestive of Neuroleptic Malignant Syndrome Symptom Complex (see sectiom 4.4) have been reported following reduction or discontinuation of Tasmar and following introduction of Tasmar when this was accompanied by a significant reduction in other concomitant dopaminergic medications.
Croatian: Nakon smanjenja doze ili prestanka liječenja Tasmarom, ili nakon početka liječenja Tasmarom kada je to bilo praćeno značajnim smanjenjem drugih istodobno primjenjivanih dopaminergičkih lijekova, prijavljeni su izolirani slučajevi bolesnika sa simptomima koji upućuju na grupu simptoma neuroleptičkog malignog sindroma (vidjeti dio 4.4).
English: Titanium dioxide
Croatian: • Teška diskinezija
English: Dyskinesia
Croatian: OBLIK
English: Neuroleptic Malignant Syndrome Symptom Complex (see section 4.4)
Croatian: Poremećaji živčanog sustava vrlo često diskinezija distonija glavobolja omaglica somnolencija ortostatske smetnje rijetko grupa simptoma neuroleptičkog malignog sindroma (vidjeti dio 4.4)
English: How to store Tasmar Keep this medicine out of the sight and reach of children.
Croatian: Ovaj lijek čuvajte izvan pogleda i dohvata djece.
English: Yellow iron oxide Ethylcellulose
Croatian: Film ovojnica: hidroksipropilmetilceluloza talk željezov oksid, žuti etilceluloza titanijev dioksid triacetin natrijev laurilsulfat
English: Tasmar 200 mg film-coated tablets Tolcapone
Croatian: Tasmar 200 mg filmom obložene tablete tolkapon
English: Tasmar 100 mg film-coated tablets Tolcapone
Croatian: Tasmar 100 mg filmom obložene tablete tolkapon
English: It may harm them, even if their symptoms seem the same as yours.
Croatian: Može im štetiti, čak i ako su njihovi znakovi bolesti jednaki Vašima.
English: The daily dose should be divided into at least two single doses.
Croatian: Dnevnu dozu treba podijeliti na najmanje dvije zasebne doze.
English: FIRST PRESCRIPTION
Croatian: PRVI RECEPT
English: The higher the dose, the higher the risks but all doses carry a risk.
Croatian: Što je veća doza, veći su i rizici, ali sve doze sa sobom nose određen rizik.
English: Your doctor will discuss this with you but you should also follow the advice in section 2 of this leaflet.
Croatian: Vaš će liječnik razgovarati s Vama o tome, ali morate se pridržavati i savjeta u dijelu 2. ove upute.
English: This is a greater risk of major malformations than for the general population, for whom the risk is about 2-3%.
Croatian: Ovaj rizik od značajnih malformacija veći je nego u općoj populaciji, u kojoj iznosi približno 2-3%.
English: There are limited data on the long term outcomes.
Croatian: Podaci o dugoročnim ishodima su ograničeni.
English: Afibrinogenemia has also been reported and may be fatal.
Croatian: Prijavljena je i afibrinogenemija, koja može biti smrtonosna.
English: Talk to your doctor or family planning clinic if you need advice on contraception.
Croatian: Razgovarajte sa svojim liječnikom ili otiđite u centar za planiranje obitelji ako trebate savjet o kontracepciji.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Informacije o lijeku mogu naknadno revidirati nacionalna nadležna tijela u suradnji s referentnom državom članicom, ako je to potrebno, sukladno postupcima propisanima u poglavlju 4. glave III Direktive 2001/83/EZ.
English: Your doctor will stop your treatment and advise you further.
Croatian: Liječnik će prekinuti liječenje i savjetovati Vas o daljnjim postupcima.
English: Developmental disorders
Croatian: Razvojni poremećaji
English: In particular the prescriber must ensure the patient understands:
Croatian: Osobito je važno da se liječnik koji propisuje lijek pobrine da bolesnica razumije:
English: Because valproate has been used for many years we know that in women who take valproate around 10 babies in every 100 will have birth defects.
Croatian: Budući da se valproat koristi već mnogo godina, znamo da će u žena liječenih valproatom približno 10 djece na svakih 100 rođenih imati prirođene mane.
English: • It can cause serious birth defects and can affect the way in which the child develops as it grows.
Croatian: • Može uzrokovati ozbiljne prirođene mane i utjecati na to kako se dijete razvija dok raste.
English: Available data show an increased incidence of minor and major malformations.
Croatian: Dostupni podaci ukazuju na povećanu incidenciju manjih i većih malformacija.
English: If based on a careful evaluation of the risks and the benefits valproate treatment is continued during the pregnancy, it is recommended to: - Use the lowest effective dose and divide the daily dose valproate into several small doses to be taken throughout the day.
Croatian: Ako se temeljem pomne procjene rizika i koristi liječenje valproatom nastavi tijekom trudnoće, preporučuje se: - Primijeniti najnižu djelotvornu dozu i podijeliti dnevnu dozu na nekoliko manjih doza koje se uzimaju tijekom dana.
English: Valproate is excreted in human milk with a concentration ranging from 1% to 10% of maternal serum levels.
Croatian: Valproat se izlučuje u majčino mlijeko u koncentraciji koja se kreće u rasponu od 1% do 10% koncentracije u serumu majke.
English: If you decide later you want to have a child you should not stop taking your medicine until you have discussed this with your doctor and agreed a plan for switching you onto another product if this is possible.
Croatian: Ako kasnije odlučite da želite imati dijete, nemojte prestati uzimati lijek dok o tome ne razgovarate sa svojim liječnikom i dok s njim ne dogovorite plan za prelazak na neki drugi lijek, ako je to moguće.
English: Data derived from a meta-analysis (including registries and cohort studies) has shown that 10.73% of children of epileptic women exposed to valproate monotherapy during pregnancy suffer from congenital malformations (95% CI: 8.16 -13.29).
Croatian: Podaci dobiveni u meta-analizi (uključujući registre i kohortna ispitivanja) pokazuju da 10,73% djece žena s epilepsijom liječenih monoterapijom valproatom tijekom trudnoće ima prirođene malformacije (95% CI: 8,16 - 13,29).
English: You should talk to your doctor well before you become pregnant so that you can put several actions in place so that your pregnancy goes as smoothly as possible and any risks to you and your unborn child are reduced as much as possible.
Croatian: Razgovarajte sa svojim liječnikom puno prije nego što zatrudnite kako biste mogli poduzeti neke mjere koje će omogućiti da trudnoća prođe što mirnije i da se što više smanje rizici za Vas i Vaše nerođeno dijete.
English: • The nature and the magnitude of the risks of exposure during pregnancy, in particular the teratogenic risks and the risks of developmental disorders.
Croatian: • prirodu i opseg rizika izlaganja lijeku tijekom trudnoće, osobito teratogene rizike i rizike od razvojnih poremećaja
English: If this is the first time you have been prescribed valproate your doctor will have explained the risks to an unborn child if you become pregnant.
Croatian: Ako je ovo prvi put da Vam je propisan valproat, liječnik Vam je vjerojatno objasnio rizike za nerođeno dijete ako zatrudnite.
English: • The need for regular review of treatment.
Croatian: • potrebu za redovitim ocjenjivanjem liječenja
English: The exact gestational period of risk for these effects is uncertain and the possibility of a risk throughout the entire pregnancy cannot be excluded.
Croatian: Nije poznato točno gestacijsko razdoblje u kojem su ti rizici prisutni pa se ne može isključiti mogućnost postojanja rizika tijekom čitave trudnoće.
English: • Do not stop using your contraception before you have talked to your doctor and worked together on a plan to ensure your epilepsy/bipolar disorder is controlled and the risks to your baby are reduced.
Croatian: • Nemojte prestati koristiti kontracepciju prije nego što razgovarate sa svojim liječnikom i zajedno osmislite plan kojim ćete epilepsiju/bipolarni poremećaj držati pod kontrolom i smanjiti rizik za Vaše dijete.
English: Case reports indicate that fertility dysfunctions are reversible after treatment discontinuation.
Croatian: Prikazi slučajeva pokazuju da su poremećaji plodnosti reverzibilni nakon prekida liječenja.
English: Your doctor may decide to change the dose of valproate or switch you to another medicine before you start trying for a baby.
Croatian: Vaš će liječnik možda odlučiti promijeniti dozu valproata ili će Vas prebaciti na drugi lijek prije nego što pokušate zatrudnjeti.
English: Do not stop taking your contraception, until you have discussed this with your doctor.
Croatian: Nemojte prestati koristiti kontracepciju dok o tome ne razgovarate sa svojim liječnikom.
English: • The need to use effective contraception.
Croatian: • potrebu za korištenjem učinkovite kontracepcije
English: Congenital malformations and developmental disorders (see section 4.4 and section 4.6).
Croatian: Prirođene malformacije i razvojni poremećaji (vidjeti dio 4.4 i dio 4.6).
English: • If you are a woman capable of becoming pregnant your doctor should only prescribe valproate for you if nothing else works for you.
Croatian: • Ako ste žena koja može zatrudnjeti, liječnik Vam smije propisati valproat samo ako ništa drugo kod Vas ne djeluje.
English: The use of a prolonged release formulation may be preferable to other treatment formulations in order to avoid high peak plasma concentrations.
Croatian: Formulacija s produljenim oslobađanjem mogla bi biti pogodnija za liječenje od ostalih formulacija kako bi se izbjegle visoke vršne koncentracije u plazmi.
English: This hemorrhagic syndrome is related to thrombocytopenia, hypofibrinogenemia and/or to a decrease in other coagulation factors.
Croatian: Taj je hemoragijski sindrom povezan s trombocitopenijom, hipofibrinogenemijom i/ili smanjenom razinom drugih koagulacijskih faktora.
English: Intelligence quotient (IQ) measured in school aged children (age 6) with a history of valproate exposure in utero was on average 7-10 points lower than those children exposed to other antiepileptics.
Croatian: Kvocijent inteligencije (IQ) mjeren u djece školske dobi (6-godišnjaci) koja su bila izložena valproatu in utero prosječno je bio 7-10 bodova niži nego u djece izložene drugim antiepilepticima.
English: Studies in preschool children exposed in utero to valproate show that up to 30-40% experience delays in their early development such as talking and walking later, lower intellectual abilities, poor language skills (speaking and understanding) and memory problems.
Croatian: Ispitivanja provedena u djece predškolske dobi izložene valproatu in utero pokazuju da do 30-40% djece ima zastoje u ranom razvoju, kao što su kasniji početak govora i hodanja, slabije razvijene intelektualne sposobnosti, loše jezične vještine (govor i razumijevanje) te poteškoće s pamćenjem.
English: The prescriber must ensure that the patient is provided with comprehensive information on the risks alongside relevant materials, such as a patient information booklet, to support her understanding of the risks.
Croatian: Liječnik koji propisuje lijek mora bolesnici dati detaljne informacije o rizicima, kao i relevantne materijale poput knjižice s informacijama za bolesnicu, kako bi joj pomogao razumjeti rizike.
English: Stop taking valproate and schedule an urgent appointment with your doctor.
Croatian: Prestanite uzimati valproat i hitno posjetite svoga liječnika.
English: Data have shown that exposure to valproate in utero can have adverse effects on mental and physical development of the exposed children.
Croatian: Podaci pokazuju da izloženost valproatu in utero može štetno utjecati na mentalni i fizički razvoj izložene djece.
English: However, this syndrome must be distinguished from the decrease of the vitamin-K factors induced by phenobarbital and enzymatic inducers.
Croatian: Međutim, taj se sindrom mora razlikovati od smanjenja razine faktora ovisnih o vitaminu K koje induciraju fenobarbital i induktori enzima.
English: Although the role of confounding factors cannot be excluded, there is evidence in children exposed to valproate that the risk of intellectual impairment may be independent from maternal IQ.
Croatian: Iako se ne može isključiti uloga ometajućih faktora, postoje dokazi koji pokazuju da bi rizik od poremećaja intelektualnih sposobnosti u djece izložene valproatu mogao biti neovisan o majčinu kvocijentu inteligencije.
English: • Do not take valproate if you are pregnant or if you are a women of childbearing potential and you are not using effective contraception.
Croatian: • Nemojte uzimati valproat ako ste trudni ili ako ste žena u reproduktivnoj dobi koja ne koristi učinkovitu kontracepciju.
English: Ask your doctor about taking folic acid.
Croatian: Pitajte svog liječnika o uzimanju folne kiseline.
English: Female children, female adolescents and woman of childbearing potential (see above and section 4.4)
Croatian: Djevojčice, adolescentice i žene reproduktivne dobi (vidjeti gore i dio 4.4)
English: If you are trying for a baby you should not use valproate.
Croatian: Ako pokušavate zatrudnjeti, ne smijete koristiti valproat.
English: The risk is dose dependent but a threshold dose below which no risk exists cannot be established.
Croatian: Rizik ovisi o dozi, ali ne može se utvrditi granična doza ispod koje rizik ne postoji.
English: • If you take valproate during pregnancy you have a higher risk than other women of having a child with birth defects that require medical treatment.
Croatian: • Ako uzimate valproat tijekom trudnoće, kod Vas postoji veći rizik da ćete roditi dijete s prirođenim manama koje će trebati liječiti nego kod drugih žena.
English: [This sentence below should be adapted to National requirements] Make sure you read the patient booklet and sign the Acknowledgement of Risk form which should be given to you and discussed with you by your doctor or pharmacist.
Croatian: [Sljedeću rečenicu treba prilagoditi nacionalnim zahtjevima] Obavezno pročitajte Knjižicu za bolesnicu i potpišite obrazac kojim potvrđujete da ste upoznati s rizikom, koji bi Vam trebao dati i o njemu s Vama razgovarati
English: Female children/Female adolescents/Women of childbearing potential/Pregnancy:
Croatian: Djevojčice/adolescentice/žene reproduktivne dobi/trudnice:
English: The benefit and risk should be carefully reconsidered at regular treatment reviews, at puberty and urgently when a woman of childbearing potential treated with <invented name> plans a pregnancy or if she becomes pregnant.
Croatian: Koristi i rizike treba pomno ponovno razmotriti tijekom redovitih ocjena liječenja, u pubertetu te hitno kada žena reproduktivne dobi liječena lijekom <Zaštićeno ime> planira trudnoću ili zatrudni.
English: • If a woman plans a pregnancy or becomes pregnant, valproate therapy should be stopped.
Croatian: • Ako žena planira trudnoću ili zatrudni, terapija valproatom mora se prekinuti.
English: [The text below should be inserted in all indications].
Croatian: [Tekst u nastavku treba uključiti kod svih indikacija].
English: Available data suggest that antiepileptic polytherapy including valproate is associated with a greater risk of congenital malformations than valproate monotherapy.
Croatian: Dostupni podaci ukazuju na to da se antiepileptična politerapija koja uključuje valproat povezuje s većim rizikom od prirođenih malformacija nego monoterapija valproatom.
English: Available data show that children exposed to valproate in utero are at increased risk of autistic spectrum disorder (approximately three-fold) and childhood autism (approximately five-fold) compared with the general study population.
Croatian: Dostupni podaci pokazuju da u djece izložene valproatu in utero postoji povećan rizik od poremećaja iz autističnog spektra (približno trostruko veći) i autizma u djetinjstvu (približno peterostruko veći) nego u općoj ispitivanoj populaciji.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from <invented name> therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Croatian: Mora se donijeti odluka o tome hoće li se prekinuti dojenje ili obustaviti/privremeno prekinuti terapija lijekom <Zaštićeno ime>, uzimajući u obzir koristi dojenja za dijete i koristi liječenja za ženu.
English: • Valproate can be harmful to unborn children when taken by a woman during pregnancy.
Croatian: • Valproat može naštetiti nerođenom djetetu ako ga žena uzima tijekom trudnoće.
English: - To institute specialized prenatal monitoring in order to detect the possible occurrence of neural tube defects or other malformations.
Croatian: - Treba uvesti specijalizirano prenatalno praćenje kako bi se otkrila moguća oštećenja neuralne cijevi ili druge malformacije.
English: The most common types of malformations include neural tube defects, facial dysmorphism, cleft lip and palate, craniostenosis, cardiac, renal and urogenital defects, limb defects (including bilateral aplasia of the radius), and multiple anomalies involving various body systems.
Croatian: Najčešće vrste malformacija uključuju poremećaje neuralne cijevi, dismorfiju lica, rascjep usne i nepca, kraniosinostozu, oštećenja srca, bubrega i urogenitalnog trakta, oštećenja ekstremiteta (uključujući obostranu aplaziju palčane kosti) i veći broj anomalija koje zahvaćaju različite tjelesne sustave.
English: Valproate can cause birth defects and problems with early development of the child if it is taken during pregnancy.
Croatian: Valproat može uzrokovati prirođene mane i poteškoće u ranom razvoju djeteta ako se uzima tijekom trudnoće.
English: If you do become pregnant you will be monitored very closely both for the management of your underlying condition and to check how your unborn child is developing.
Croatian: Ako zatrudnite, liječnik će Vas pažljivo nadzirati kako bi mogao liječiti Vašu osnovnu bolest i kontrolirati razvoj nerođena djeteta.
English: • Valproate carries a risk if taken during pregnancy.
Croatian: • Valproat nosi određene rizike ako se uzima u trudnoći.
English: However the available evidence does not suggest it prevents the birth defects or malformations due to valproate exposure.
Croatian: Međutim, dostupni podaci ne pokazuju da ona sprječava prirođene mane ili malformacije uzrokovane izlaganjem valproatu.
English: Preferably <invented name> should be prescribed as monotherapy and at the lowest effective dose, if possible as a prolonged release formulation to avoid high peak plasma concentrations.
Croatian: <Zaštićeno ime> je poželjno propisati u monoterapiji i u najnižoj djelotvornoj dozi, po mogućnosti u formulaciji s produljenim oslobađanjem kako bi se izbjegle visoke vršne koncentracije u plazmi.
English: Valproate administration may also impair fertility in men (see section 4.8).
Croatian: Primjena valproata može negativno utjecati i na plodnost muškaraca (vidjeti dio 4.8).