FrancophonIA/ELRC3.0 huggingface dataset:
English: PACKAGE LEAFLET: Afoxolaner MERIAL 11 mg chewable tablets for dogs 2-4 kg Afoxolaner MERIAL 28 mg chewable tablets for dogs >4-10 kg Afoxolaner MERIAL 68 mg chewable tablets for dogs >10-25 kg Afoxolaner MERIAL 136 mg chewable tablets for dogs >25-50 kg
Croatian: UPUTA O VMP : Afoksolaner MERIAL 11 mg tableta za žvakanje za pse 2-4 kg Afoksolaner MERIAL 28 mg tableta za žvakanje za pse >4-10 kg Afoksolaner MERIAL 68 mg tableta za žvakanje za pse >10-25 kg Afoksolaner MERIAL 136 mg tableta za žvakanje za pse >25-50 kg
English: Afoxolaner MERIAL 11 mg chewable tablets for dogs 2-4 kg Afoxolaner MERIAL 28 mg chewable tablets for dogs >4-10 kg Afoxolaner MERIAL 68 mg chewable tablets for dogs >10-25 kg Afoxolaner MERIAL 136 mg chewable tablets for dogs >25-50 kg
Croatian: Afoksolaner MERIAL 11 mg tablete za žvakanje za pse 2-4 kg Afoksolaner MERIAL 28 mg tablete za žvakanje za pse >4-10 kg Afoksolaner MERIAL 68 mg tablete za žvakanje za pse >10-25 kg Afoksolaner MERIAL136 mg tablete za žvakanje za pse >25-50 kg
English: The patient should take one tablet once a day.
Croatian: Bolesnik treba uzimati jednu tabletu jedanput dnevno.
English: In both studies there were no cases of resistance to treatment after 48 weeks.
Croatian: U obama ispitivanjima nije bilo slučajeva rezistencije na liječenje nakon 48 tjedana.
English: What is Dovato and what is it used for?
Croatian: Što je Dovato i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Dovato?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Dovato?
English: Dovato (dolutegravir / lamivudine)
Croatian: Dovato (dolutegravir/lamivudin)
English: Other information about Dovato
Croatian: Ostale informacije o lijeku Dovato
English: Dovato is a medicine for treating infection with human immunodeficiency virus type 1 (HIV-1) in adults and adolescents over 12 years old who weigh at least 40 kg.
Croatian: Dovato je lijek za liječenje infekcije virusom humane imunodeficijencije tipa 1 (HIV-1) u odraslih i adolescenata starijih od 12 godina i tjelesne težine od najmanje 40 kg.
English: In these studies, 91% of patients with HIV-1 who took the Dovato combination no longer had detectable levels of HIV (below 50 copies per ml) after 48 week compared with 93% of those who were taking the triple combination.
Croatian: U tim ispitivanjima 91 % bolesnika zaraženih virusom HIV-1 koji su uzimali kombinaciju lijeka Dovato više nije imalo značajne razine virusa HIV (ispod 50 kopija po ml) nakon 48 tjedana, u usporedbi s 93 % onih koji su uzimali trostruku kombinaciju.
English: What are the risks associated with Dovato?
Croatian: Koji su rizici povezani s lijekom Dovato?
English: Both active substances have already been authorised in the European Union as separate tablets: dolutegravir in 2014 and lamivudine in 1996.
Croatian: Obje djelatne tvari već su odobrene u Europskoj uniji u obliku zasebnih tablete: dolutegravir u 2014., a lamivudin u 1996.
English: Dovato is available as tablets containing 50 mg of dolutegravir and 300 mg of lamivudine.
Croatian: Dovato je dostupan u obliku tableta od 50 mg dolutegravira i 300 mg lamivudina.
English: Dovato (dolutegravir / lamivudine) EMA/276259/2019
Croatian: Dovato (dolutegravir/lamivudin) EMA/276259/2019
English: Dovato does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Dovato ne liječi infekciju HIV-om ni AIDS, ali može odgoditi oštećenje imunosnog sustava te razvoj infekcija i bolesti povezanih s AIDS-om.
English: Why is Dovato authorised in the EU?
Croatian: Zašto je lijek Dovato odobren u EU-u?
English: Side effects reported with Dovato are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Dovato pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: An overview of Dovato and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Dovato i zašto je odobren u EU-u
English: Triple combination therapy is used for HIV treatment to reduce the chance of the virus becoming resistant to treatment.
Croatian: Trostruka kombinirana terapija primjenjuje se za liječenje infekcije HIV-om kako bi se smanjili izgledi da virus postane otporan na liječenje.
English: As for all medicines, data on the use of Dovato are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Dovato kontinuirano se prate.
English: Dolutegravir stops the activity of an enzyme called integrase (and is known as an integrase inhibitor), while lamivudine stops the activity of reverse transcriptase (and is known as a nucleoside reverse transcriptase inhibitor or NRTI).
Croatian: Dolutegravir zaustavlja djelovanje enzima koji se naziva integraza (a poznat je kao inhibitor integraze), a lamivudin zaustavlja djelovanje reverzne transkriptaze (i poznat je kao nukleozidni inhibitor reverzne transkriptaze ili NRTI).
English: The most common serious side effects (which may affect up to 1 in 100 people) are allergic reactions, including rash and severe liver problems.
Croatian: Najčešće ozbiljne nuspojave (koje se mogu javiti u više od 1 na 100 osoba) jesu alergijske reakcije, uključujući osip i teške probleme s jetrom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dovato have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Dovato nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: For more information about using Dovato, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Dovato pročitajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: The most common side effects with Dovato (which may affect up to 1 in 10 people) are headache, diarrhoea, nausea and difficulty sleeping.
Croatian: Najčešće nuspojave lijeka Dovato (koje se mogu javiti u više od 1 na 10 osoba) jesu glavobolja, proljev, mučnina i otežano spavanje.
English: The two active substances in Dovato, dolutegravir and lamivudine, block the activity of enzymes that the virus uses to make new copies of itself.
Croatian: Dvije djelatne tvari lijeka Dovato, dolutegravir i lamivudin, inhibiraju djelovanje enzima koje virus upotrebljava za stvaranje novih vlastitih kopija.
English: Dovato can only be obtained with a prescription and should be prescribed by a doctor who is experienced in managing HIV infection.
Croatian: Lijek Dovato izdaje se samo na recept, a treba ga propisati liječnik s iskustvom u liječenju infekcije HIV-om.
English: Dovato received a marketing authorisation valid throughout the EU on 1 July 2019 Further information on Dovato can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/dovato This overview was last updated in 08-2019.
Croatian: Više informacija o lijeku Dovato dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/dovato
English: Two main studies, involving 1,441 patients, have shown that the combination of the two active substances in Dovato is as effective at lowering the amount of HIV in the blood as a triple combination therapy (dolutegravir plus tenofovir plus emtricitabine).
Croatian: U dvama glavnim ispitivanjima, koja su obuhvatila 1 433 bolesnika, kombinacija dviju djelatnih tvari u lijeku Dovato pokazala se jednako učinkovitom u smanjenju količine HIV-a u krvi kao i terapija trostrukom kombiniranom terapijom (dolutegravir i tenofovir i emtricitabin).
English: This medicine contains the active substances dolutegravir and lamivudine and is used to treat infections that are not resistant to medicines of the same class as dolutegravir or to lamivudine.
Croatian: Ovaj lijek sadrži djelatne tvari dolutegravir i lamivudin te se primjenjuje za liječenje infekcija koje nisu otporne na lijekove istog razreda kao dolutegravir i lamivudin.
English: In two main studies, the Dovato combination was just as effective as a triple combination in patients with HIV-1, with no cases of resistance developing in these patients.
Croatian: Dovato bila je jednako učinkovita kao trostruka kombinacija u bolesnika s virusom HIV-1, pri čemu u tih bolesnika nije došlo do pojave rezistencije.
English: How does Dovato work?
Croatian: Kako djeluje Dovato?
English: What benefits of Dovato have been shown in studies?
Croatian: Koje su koristi od lijeka Dovato utvrđene u ispitivanjima?
English: How is Dovato used?
Croatian: Kako se Dovato primjenjuje?
English: Furthermore, both active substances are available in a single tablet and are acceptably safe.The European Medicines Agency therefore decided that Dovato's benefits are greater than its risks and that it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je odlučila da koristi od lijeka Dovato nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: 3 (3x1) inhalers (360(3x120) actuations) (multipack)
Croatian: 3 (3x1) inhalatora (360 (3x120) potisaka) (višestruko pakiranje)
English: 1 inhaler (120 actuations)
Croatian: 1 inhalator (120 potisaka)
English: Pack size
Croatian: Jačina
English: Uncontrollable excessive shopping or spending.
Croatian: Nekontrolirano prekomjerno kupovanje ili trošenje.
English: There is no specific antidote.
Croatian: Nema specifičnog antidota.
English: Take the next dose normally, when it is time to take it.
Croatian: Uzmite sljedeću dozu kako je uobičajeno, kada je vrijeme da je uzmete.
English: You should speak with your doctor about any suspicious skin changes.
Croatian: Morate razgovarati sa svojim liječnikom o svakoj sumnjivoj promjeni na koži.
English: Your doctor may need to adjust or stop your dose.
Croatian: Vaš liječnik će možda morati prilagoditi dozu ili prekinuti liječenje.
English: Strong impulse to gamble excessively despite serious personal or family consequences.
Croatian: Jak nagon za pretjeranim kockanjem unatoč ozbiljnim posljedicama po njih ili obitelj.
English: • Not known (frequency cannot be estimated from the available data)
Croatian: • Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka)
English: The frequency of possible side effects listed below is defined using the following convention:
Croatian: Učestalost niže navedenih mogućih nuspojava definirana je koristeći sljedeće pravilo:
English: Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.
Croatian: Promijenjen ili povećan seksualni interes i ponašanje koje je značajno zabrinjavajuće za Vas ili druge, primjerice povećan seksualni nagon.
English: This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.
Croatian: Uputa je zadnji puta revidirana u <{MM/GGGG}><{mjesec GGGG}>.
English: Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.
Croatian: Obavijestite svog liječnika ako iskusite ovakvo ponašanje; s njim ćete razgovarati o načinima kako kontrolirati ili smanjiti simptome.
English: • abnormal dreams
Croatian: • abnormalni snovi
English: The effect was evident, although its magnitude was modest in this patient population with mild disease.
Croatian: Učinak je bio očit, unatoč tome što je njegov razmjer bio skroman u ovoj populaciji bolesnika s blagom bolešću.
English: Caution should be exercised when prescribing to pregnant women.
Croatian: Nužan je oprez kod propisivanja trudnicama.
English: Rasagiline is not recommended for use in children and adolescents due to lack of data on safety and efficacy.
Croatian: Primjena razagilina ne preporučuje se u djece i adolescenata zbog nedostatka podataka o sigurnosti i djelotvornosti.
English: The recommended dose is 1 tablet of 1 mg taken by mouth once daily.
Croatian: Preporučena doza je 1 tableta od 1 mg uzeta na usta jedanput dnevno.
English: Any suspicious skin lesion should be evaluated by a specialist.
Croatian: Svako sumnjivo oštećenje kože mora se pregledati kod specijalista.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription or if you are smoking or intend to stop smoking.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzimali ili biste mogli uzimati bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta, ili ako pušite ili namjeravate prestati pušiti.
English: There was a significant and beneficial effect in quality of life (as assessed by PD-QUALIF scale).
Croatian: Učinak na kvalitetu života bio je značajan i koristan (procijenjeno PD-QUALIF ljestvicom).
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje u promet gotovog lijeka:
English: Less than 1% of rasagiline is excreted as unchanged product in urine.
Croatian: Manje od 1% razagilina se izlučuje nepromijenjeno u urinu.
English: Not applicable.
Croatian: Nije primjenjivo
English: Elderly No change in dose is required for elderly patients.
Croatian: Nije potrebna promjena doze kod starijih bolesnika.
English: No studies on the effects on the ability to drive and use machines have been performed.
Croatian: Nisu provedena ispitivanja o učincima na sposobnost upravljanja vozilima i strojevima.
English: H-2900 Komárom Hungary.
Croatian: H-2900 Komárom Mađarska.
English: Patients should be regularly monitored for the development of impulse control disorders.
Croatian: Bolesnike se mora redovito nadzirati za razvoj poremećaja kontrole impulsa.
English: • allergy
Croatian: • alergija
English: Dopamine is a chemical in the brain involved in movement control.
Croatian: Dopamin je kemijska tvar u mozgu koja je uključena u kontrolu pokreta.
English: Patients should be cautioned about operating hazardous machines, including motor vehicles, until they are reasonably certain that Rasagiline does not affect them adversely.
Croatian: Bolesnici trebaju biti oprezni pri upravljanju opasnim strojevima, uključujući motorna vozila, dok nisu dovoljno sigurni da Rasagiline na njih ne utječe štetno.
English: If you take more Rasagiline Mylan than you should If you think that you may have taken too many Rasagiline Mylan tablets, contact your doctor or pharmacist immediately.
Croatian: Ako uzmete više lijeka Rasagiline Mylan nego što ste trebali Ako mislite da ste možda uzeli previše Rasagiline Mylan tableta, odmah se obratite svom liječniku ili ljekarniku.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Croatian: • uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: CARTON FOR BLISTER PACK
Croatian: KUTIJA ZA BLISTER PAKIRANJE
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.
English: During the clinical development program, the occurrence of cases of melanoma prompted the consideration of a possible association with rasagiline.
Croatian: Tijekom programa kliničkog razvoja, pojava slučajeva melanoma potaknula je razmatranja o mogućoj povezanosti s razagilinom.
English: • low blood pressure when rising to a standing position with symptoms like dizziness/light
Croatian: • nizak krvni tlak pri ustajanju u stojeći položaj sa simptomima kao što su omaglica/ošamućenost
English: Rasagiline is rapidly absorbed, reaching peak plasma concentration (Cmax) in approximately 0.5 hours.
Croatian: Razagilin se brzo apsorbira, dosežući vršnu koncentraciju u plazmi (Cmax) za približno 0,5 sati.
English: Ask your doctor for advice prior to driving or using machines.
Croatian: Posavjetujte se sa svojim liječnikom prije upravljanja vozilima ili strojevima.
English: Rasagiline is administered orally, at a dose of 1 mg once daily with or without levodopa.
Croatian: Razagilin se primjenjuje peroralno, u dozi od 1 mg jednom dnevno, sa ili bez levodope.
English: Rasagiline Mylan is used for the treatment of Parkinson's disease.
Croatian: Rasagiline Mylan se primjenjuje za liječenje Parkinsonove bolesti.
English: It can be used together with or without levodopa (another medicine that is used to treat Parkinson's disease).
Croatian: Može se primjeniti zajedno s levodopom ili bez levodope (drugi lijek koji se primjenjuje za liječenje Parkinsonove bolesti).
English: Adverse events were mild or moderate and not related to rasagiline treatment.
Croatian: Štetni događaji bili su blagi ili umjereni i nisu bili povezani s liječenjem razagilinom.
English: Animals studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravne ili neizravne štetne učinke na trudnoću, embrionalni/fetalni razvoj, porod ili postnatalni razvoj (vidjeti dio 5.3).
English: The mean volume of distribution following a single intravenous dose of rasagiline is 243 l.
Croatian: Distribucija Srednji volumen distribucije nakon jedne intravenske doze razagilina je 243 l.
English: Rasagiline Mylan helps to increase and sustain levels of dopamine in the brain.
Croatian: Rasagiline Mylan pomaže u povećavanju i održavanju razina dopamina u mozgu.
English: In addition, skin cancer was reported in around 1% of patients in the placebo controlled clinical trials.
Croatian: Dodatno, rak kože je bio prijavljen u oko 1 % bolesnika u placebo kontroliranim kliničkim ispitivanjima.
English: Pharmacotherapeutic group: Anti-Parkinson drugs, Monoamine oxidase-B inhibitors, ATC code: N04BD02
Croatian: Farmakoterapijska skupina: Antiparkinsonici, inhibitori monoaminooksidaze B, ATK oznaka: N04BD02
English: In case of overdose, patients should be monitored and the appropriate symptomatic and supportive therapy instituted.
Croatian: U slučaju predoziranja, bolesnike se mora nadzirati te započeti odgovarajuće simptomatsko i suportivno liječenje.
English: • numbness and muscle weakness of the hand (carpal tunnel syndrome)
Croatian: • utrnulost i slabost mišića ruke (sindrom karpalnog tunela)
English: Blister packs of 7, 10, 28, 30, 100 or 112 tablets PVC/PVDC/Al.
Croatian: Blister pakiranja od 7, 10, 28, 30, 100 ili 112 tableta PVC/PVDC/Al.
English: • difficulty in muscular coordination (balance disorder)
Croatian: • poteškoće u mišićnoj koordinaciji (poremećaj ravnoteže)
English: The following side effects have been reported in placebo controlled clinical trials:
Croatian: Sljedeće nuspojave su prijavljene u placebo kontroliranim kliničkim ispitivanjima:
English: With Parkinson's disease, there is a loss of cells that produce dopamine in the brain.
Croatian: Kod Parkinsonove bolesti postoji gubitak stanica koje proizvode dopamin u mozgu.
English: Rasagiline did not present genotoxic potential in vivo and in several in vitro systems using bacteria or hepatocytes.
Croatian: Razagilin nije pokazao genotoksični potencijal in vivo te u nekoliko in vitro sustava korištenjem bakterija ili hepatocita.
English: These symptoms may resemble those observed with non-selective MAO inhibitors.
Croatian: Ovi simptomi mogu nalikovati na one opažene kod neselektivnih MAO inhibitora.
English: These results indicate that rasagiline's therapeutic concentrations are unlikely to cause any clinically significant interference with substrates of these enzymes.
Croatian: Ovi rezultati indiciraju da nije vjerojatno da terapijske koncentracije razagilina prouzročuju bilo kakvu klinički značajnu interferenciju sa supstratima ovih enzima.
English: In both studies, the primary measure of efficacy was the change from baseline to treatment period in the mean number of hours that were spent in the “OFF” state during the day (determined from “24-hour” home diaries completed for 3 days prior to each of the assessment visits).
Croatian: U oba je ispitivanja primarna mjera djelotvornosti bila promjena u srednjem broju sati provedenih u „OFF“ stanju tijekom dana (određivano iz „24-satnih“ kućnih dnevnika popunjavanih tijekom 3 dana prije svakog posjeta procjene) od početne vrijednosti do razdoblja liječenja.
English: Parkinson's disease is associated with symptoms of hallucinations and confusion.
Croatian: Parkinsonova bolest je povezana sa simptomima halucinacija i konfuzije.
English: There was also a statistically significant improvement over placebo with the rasagiline 0.5 mg group, yet the magnitude of improvement was lower.
Croatian: Također je postojalo i statistički značajno poboljšanje u razagilin 0,5 mg skupini u usporedbi s placebom, iako je razmjer poboljšanja bio manji.
English: • abnormal results of blood tests (leucopenia)
Croatian: • abnormalni rezultati krvnih testova (leukopenija)
English: Overdose can be associated with significant inhibition of both MAO-A and MAO-B.
Croatian: Predoziranje može biti povezano sa značajnom inhibicijom MAO-A i MAO-B.
English: Hypersensitivity to the active substance or to any of the excipients (listed in section 6.1).
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari (navedene u dijelu 6.1).
English: There have been reports of hypotensive effects when rasagiline is taken concomitantly with levodopa.
Croatian: Bilo je prijava hipotenzivnih učinaka kada je razagilin uziman istodobno s levodopom.
English: Decreasing the dose of levodopa may ameliorate this side effect.
Croatian: Smanjenje doze levodope može ublažiti ovu nuspojavu.
English: In a single-dose study healthy volunteers received 20 mg/day and in a ten-day study healthy volunteers received 10 mg/day.
Croatian: U ispitivanju s jednokratnom primjenom lijeka zdravi dobrovoljci su primili 20 mg/dan, a u desetodnevnom ispitivanju su primali 10 mg/dan.
English: Patients with Parkinson's disease are particularly vulnerable to the adverse effects of hypotension due to existing gait issues.
Croatian: Bolesnici s Parkinsonovom bolesti su posebno osjetljivi na nepovoljne učinke hipotenzije zbog postojećih problema s hodanjem.
English: There were no cases of serotonin syndrome in the rasagiline clinical program in which 115 patients were exposed concomitantly to rasagiline and tricyclics and 141 patients were exposed to rasagiline and SSRIs/ SNRIs.
Croatian: Nije bilo slučajeva serotoninskog sindroma u kliničkom programu s razagilinom u kojem je 115 bolesnika istodobno bilo izloženo razagilinu i triciklicima, a 141 bolesnik bio je izložen razagilinu i SSRI-ima/SNRI-ima.
English: The metabolism of rasagiline proceeds through two main pathways: N-dealkylation and/or hydroxylation to yield: 1-Aminoindan, 3-hydroxy-N-propargyl-1 aminoindan and 3-hydroxy-1-aminoindan.
Croatian: Metabolizam razagilina se odvija kroz dva glavna puta: N-dealkilacijom i/ili hidroksilacijom te nastaju: 1-aminoindan, 3-hidroksi-N-propargil-1 aminoindan i 3-hidroksi-1 aminoindan.
English: Take the Rasagiline Mylan carton with you to show the doctor or pharmacist.
Croatian: Ponesite sa sobom Rasagiline Mylan kutiju da pokažete svom liječniku ili ljekarniku.