FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee recommended that Olanzapine Cipla be given marketing authorisation.
Croatian: Povjerenstvo je preporučilo izdavanje odobrenja za stavljanje u promet lijeka Olanzapine Cipla u EU-u.
English: What is Olanzapine Cipla used for?
Croatian: Za što se Olanzapine Cipla koristi?
English: How is Olanzapine Cipla used?
Croatian: Kako je Olanzapine Cipla ispitivan?
English: As a result, levodopa remains active for longer.
Croatian: Kao rezultat toga levodopa ostaje aktivna dulje vrijeme.
English: The patients then lose their ability to control their movements reliably.
Croatian: Bolesnici potom gube sposobnost pouzdane kontrole pokreta.
English: The full EPAR for Ongentys can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Ongentys nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Among these, dyskinesia (difficulty controlling movement) may affect around 2 in 10 people.
Croatian: Među ostalima, diskinezija (teškoća pri kontroli pokreta) može se javiti u otprilike 2 na 10 osoba.
English: Ongentys is available as capsules (25 mg and 50 mg) to be taken by mouth.
Croatian: Ongentys je dostupan u obliku kapsula (25 mg i 50 mg) koje se uzimaju na usta.
English: Fluctuations happen when the effects of the medication wear off and symptoms re-emerge before the next dose is due.
Croatian: Fluktuacije se događaju kada učinci lijeka oslabe i kada se ponovno pojave simptomi prije uzimanja sljedeće doze.
English: What measures are being taken to ensure the safe and effective use of Ongentys?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ongentys?
English: Ongentys opicapone
Croatian: Ongentys opikapon
English: This study looked at how well the treatments reduced the time when patients have more difficulty moving about, called ‘off periods'.
Croatian: Ovo je ispitivanje istražilo koliko su dobro terapije skratile vrijeme u kojem su bolesnici imali više poteškoća pri kretanju, takozvana „razdoblja isključenosti”.
English: Regarding its safety, Ongentys was considered to be comparable to other medicines of the same class.
Croatian: U pogledu sigurnosti, Ongentys se smatrao usporediv s drugim lijekovima istog razreda.
English: Ongentys must not be used in:
Croatian: Ongentys se ne smije primjenjivati:
English: It is not intended to provide practical advice on how to use Ongentys.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Ongentys.
English: This is a summary of the European public assessment report (EPAR) for Ongentys.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Ongentys.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ongentys's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Ongentys nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: This helps to improve the symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Croatian: To pomaže poboljšavanju simptoma Parkinsonove bolesti kao što su ukočenost i usporeni pokreti.
English: Why is Ongentys approved?
Croatian: Zašto je Ongentys odobren?
English: Both studies were extended for one additional year and confirmed the benefits of Ongentys when used long-term.
Croatian: Oba su ispitivanja produljena za jednu dodatnu godinu te su potvrdila koristi od dugoročne primjene lijeka Ongentys.
English: The benefits of Ongentys in Parkinson's disease were investigated in two main studies.
Croatian: Koristi lijeka Ongentys u Parkinsonovoj bolesti ispitivane su u okviru dvaju glavnih ispitivanja.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ongentys have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza koje zdravstveni djelatnici te bolesnici trebaju poštovati radi sigurne i učinkovite upotrebe lijeka Ongentys nalaze se u sažetku opisa svojstava proizvoda i u uputi o lijeku.
English: Ongentys is used when these fluctuations cannot be treated with the standard levodopa-containing combinations alone.
Croatian: Ongentys se primjenjuje kad se ove fluktuacije ne mogu liječiti samo standardnim kombinacijama koje sadržavaju levodopu.
English: What is Ongentys and what is it used for?
Croatian: Što je Ongentys i za što se koristi?
English: Opicapone blocks an enzyme that is involved in the breakdown of levodopa in the body called catechol-O-methyl transferase (COMT).
Croatian: Opikapon blokira enzim koji je uključen u razgradnju levodope u tijelu, a koji se naziva katekol-O-metiltransferaza (COMT).
English: In both studies, patients had on average off periods of about 6 to 7 hours at the start of the study.
Croatian: U oba su ispitivanja u početku bolesnici imali razdoblja isključenosti od otprilike 6 do 7 sati.
English: It enhances the effects of levodopa, a copy of the neurotransmitter dopamine that can be taken by mouth.
Croatian: Pojačava učinak levodope, tvari koja je kopija neurotransmitera dopamina koja se može uzimati na usta.
English: The recommended dose is 50 mg, taken once a day at bedtime, at least one hour before or after levodopa combination medicines.
Croatian: Preporučena je doza 50 mg, jedanput na dan prije spavanja, najmanje jedan sat prije ili nakon uzimanja kombinacije koja sadrži levodopu.
English: They are linked to a reduction in the effect of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and having difficulty moving about.
Croatian: One se povezuju sa smanjenim učinkom levodope, kada bolesnik doživljava iznenadne izmjene „aktivnog” stanja i mogućnosti kretanja te „pasivnog” stanja i poteškoća s kretanjem.
English: Other information about Ongentys
Croatian: Ostale informacije o lijeku Ongentys
English: In patients with Parkinson's disease, the cells in the brain that produce the neurotransmitter dopamine begin to die and the amount of dopamine in the brain decreases.
Croatian: U bolesnika s Parkinsonovom bolesti stanice mozga koje proizvode neurotransmiter dopamin počinju odumirati i količina dopamina u mozgu se smanjuje.
English: In the second study, which also looked at the reduction in off periods, Ongentys was compared with placebo in 427 patients who were taking a levodopa / DDCI combination.
Croatian: U okviru drugog ispitivanja koje je isto tako istražilo skraćivanje razdoblja isključenosti, Ongentys je uspoređen s placebom u 427 bolesnika koji su uzimali kombinaciju levodope / DDCI-ja.
English: Ongentys contains the active substance opicapone.
Croatian: Ongentys sadržava djelatnu tvar opikapon.
English: Ongentys is a medicine used to treat adults with Parkinson's disease, a progressive brain disorder that causes shaking and muscle stiffness, and slows movement.
Croatian: Ongentys je lijek koji se primjenjuje za liječenje odraslih osoba s Parkinsonovom bolešću, progresivnim moždanim poremećajem koji uzrokuje drhtanje i krutost mišića te usporava kretanje.
English: • patients taking medicines known as non-selective monoamine oxidase (MAO) inhibitors except when used to treat Parkinson's disease.
Croatian: • u bolesnika koji uzimaju lijekove poznate kao neselektivni inhibitori monoaminooksidaze, osim ako se primjenjuju za liječenje Parkinsonove bolesti.
English: The active substance in Ongentys, opicapone, works to restore the levels of dopamine in the parts of the brain that control movement and coordination.
Croatian: Opikapon, djelatna tvar u lijeku Ongentys, djeluje u svrhu obnove razina dopamina u dijelovima mozga koji kontroliraju pokret i koordinaciju.
English: After 14-15 weeks, off periods were shortened by 117 minutes (almost 2 hours) in patients taking Ongentys 50 mg, compared with 96 minutes (about 1 and a half hour) in patients taking the comparator medicine entacapone and 56 minutes (less than 1 hour) in patients taking placebo.
Croatian: Nakon 14-15 tjedana razdoblja isključenosti u bolesnika koji su uzimali Ongentys 50 mg skratila su se za 117 minuta (gotovo 2 sata), u usporedbi s 96 minuta (otprilike jedan i pol sat) u bolesnika koji su uzimali usporedni lijek entakapon te 56 minuta (manje od jednog sata) u bolesnika koji su uzimali placebo.
English: The most common side effects with Ongentys are disorders of the nervous system (brain and spinal cord).
Croatian: Najčešća nuspojava lijeka Ongentys jesu poremećaji živčanog sustava (mozak i leđna moždina).
English: What are the risks associated with Ongentys?
Croatian: Koji su rizici povezani s lijekom Ongentys?
English: Ongentys was shown to be more effective than placebo and at least as effective as the comparator entacapone in reducing off periods in patients with Parkinson's disease taking levodopa combination medicines.
Croatian: Ongentys se pokazao djelotvornijim od placeba te barem jednako djelotvoran kao usporedni entakapon u skraćivanju razdoblja isključenosti u bolesnika s Parkinsonovom bolesti koji su uzimali kombinaciju lijekova s levodopom.
English: • patients with a history of neuroleptic malignant syndrome (a nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres);
Croatian: • u bolesnika koji su u prošlosti imali maligni neuroleptički sindrom (poremećaj živčanog sustava prouzročen antipsihotičkim lijekovima) ili rabdomiolizu (raspad mišićnog tkiva);
English: Ongentys is used as an add-on to levodopa / DOPA decarboxylase inhibitors (DDCI) (other medicines for Parkinson's disease) in patients who are having fluctuations in the control of their condition.
Croatian: Ongentys se primjenjuje kao dodatna terapija uz terapiju kombinacijom levodope/inhibitora DOPA dekarboksilaze (DDCI) (ostali lijekovi za liječenje Parkinsonove bolesti) u bolesnika koji imaju fluktuacije u kontroliranju svoje bolesti.
English: • patients with tumours of the adrenal glands (small glands located on top of the kidneys) such as pheochromocytoma and paraganglioma;
Croatian: • u bolesnika s tumorima nadbubrežnih žlijezda (male žlijezde koje se nalaze na vrhu bubrega) kao što su feokromocitom i paragangliom;
English: For more information about treatment with Ongentys, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Ongentys pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: After 14-15 weeks, off periods were shortened by 119 minutes (almost 2 hours) in patients taking Ongentys 50 mg, compared with 64 minutes in patients taking placebo.
Croatian: Nakon 14-15 tjedana razdoblja isključenosti u bolesnika koji su uzimali Ongentys 50 mg skratila su se za 119 minuta (gotovo 2 sata), u usporedbi sa 64 minute u bolesnika koji su uzimali placebo.
English: How is Ongentys used?
Croatian: Kako se Ongentys koristi?
English: How does Ongentys work?
Croatian: Kako djeluje Ongentys?
English: For practical information about using Ongentys, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Ongentys pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: In the first study, 600 patients with fluctuations were given Ongentys, entacapone (another medicine for Parkinson's disease) or placebo (a dummy treatment), in addition to their current levodopa / DDCI combination.
Croatian: U okviru prvog ispitivanja 600 bolesnika s fluktuacijama, osim svoje trenutačne kombinacije levodope / DDCIja, primilo je Ongentys, entakapon (drugi lijek za Parkinsonovu bolest) ili placebo (slijepo liječenje).
English: What benefits of Ongentys have been shown in studies?
Croatian: Koje su koristi lijeka Ongentys utvrđene u ispitivanjima?
English: For the full list of all side effects reported with Ongentys, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Ongentys potražite u uputi o lijeku.
English: - if you are a woman.
Croatian: - ako ste žena.
English: ● Risk Management Plan (RMP) Not applicable.
Croatian: • Plan upravljanja rizikom (RMP) Nije primjenjivo.
English: Date of latest renewal: 9 September 2014.
Croatian: Datum posljednje obnove: 09. rujna 2014.
English: 4 years
Croatian: 4 godine.
English: However, due to high inter-subject variability, these differences were not statistically significant.
Croatian: Međutim, zbog visoke varijabilnosti između ispitanika, ove razlike nisu bile statistički značajne.
English: Therefore the use of such combinations is not recommended.
Croatian: Stoga se primjena takvih kombinacija ne preporučuje.
English: - if you are taking riociguat.
Croatian: - ako uzimate riociguat.
English: 036 80 Martin Slovak Republic
Croatian: 036 80 Martin Slovačka Republika
English: Children and adolescents This medicine should NOT be given to children and adolescents under the age of 18.
Croatian: Ovaj se lijek NE smije davati djeci i adolescentima mlađim od 18 godina.
English: In cases of overdose, standard supportive measures should be adopted as required.
Croatian: U slučajevima predoziranja po potrebi treba primijeniti standardne suportivne mjere.
English: - if you have low blood pressure.
Croatian: 5. ako imate nizak krvni tlak.
English: It is not possible to determine whether these events are related directly to these factors or to other factors.
Croatian: Nije moguće odrediti jesu li ti događaji povezani direktno s tim ili s drugim čimbenicima.
English: PVdC/PVC/Aluminium blisters.
Croatian: PVdC/PVC/Aluminijski blisteri.
English: Do not use nitrates to treat your chest pain.
Croatian: • Nemojte uzimati nitrate za liječenje bolova u prsima.
English: There are no adequate and well-controlled studies in pregnant or breast-feeding women.
Croatian: Nisu provedena odgovarajuća ili dobro kontrolirana ispitivanja u trudnica ili dojilja.
English: Alcoholic drink can make erection difficulties worse.
Croatian: Alkoholna pića mogu pogoršati probleme s erekcijom.
English: The maximum recommended dose is 100 mg.
Croatian: Najviša preporučena doza je 100 mg.
English: Elderly Dosage adjustments are not required in elderly patients (≥ 65 years old).
Croatian: Starije osobe Prilagodbe doziranja u starijih bolesnika nisu potrebne (≥ 65 godina starosti).
English: Stevens-Johnson Syndrome (SJS)*, Toxic Epidermal Necrolysis (TEN)*
Croatian: Stevens-Johnsonov sindrom (SJS), * toksična epidermalna nekroliza (TEN) *
English: You should not take more film-coated tablets than your doctor tells you to.
Croatian: Ne smijete uzeti više filmom obloženih tableta nego što Vam je propisao liječnik.
English: The safety and efficacy of sildenafil was maintained in long-term studies.
Croatian: Sigurnost i djelotvornost sildenafila bila je održana u dugotrajnim ispitivanjima.
English: Most, but not all, of these patients had pre-existing cardiovascular risk factors.
Croatian: Većina, ali ne svi od ovih bolesnika, imala je već od ranije prisutne kardiovaskularne čimbenike rizika.
English: Teva Operations Poland Sp. z o.o.
Croatian: Teva Operations Poland Sp. z o.o. ul.
English: Further information on clinical trials
Croatian: Dodatne informacije o kliničkim ispitivanjima
English: The maximum recommended dosing frequency is once per day.
Croatian: Najveća preporučena učestalost doziranja iznosi jednom dnevno.
English: Its effect is more potent on PDE5 than on other known phosphodiesterases.
Croatian: Njegov učinak je jači na PDE5 nego na druge poznate fosfodiesteraze.
English: Concomitant use with alpha-blockers
Croatian: Istodobna primjena s alfa-blokatorima
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 December 2009.
Croatian: Datum prvog odobrenja: 23. prosinca 2009.
English: Many events were reported to occur during or shortly after sexual intercourse and a few were reported to occur shortly after the use of sildenafil without sexual activity.
Croatian: Za mnoge događaje je prijavljeno da su nastupili za vrijeme ili ubrzo nakon spolnog odnosa, a za nekolicinu da su nastali ubrzo nakon primjene sildenafila bez spolne aktivnosti.
English: Due to the nitrate component it has the potential to result in a serious interaction with sildenafil.
Croatian: Zbog svoje nitratne komponente ima potencijal da dovede do ozbiljnih interakcija sa sildenafilom.
English: Effect on bleeding
Croatian: Učinak na krvarenje
English: Very common (may affect more than 1 in 10 people): headache.
Croatian: Vrlo često (mogu se javiti kod više od 1 na 10 osoba): glavobolja
English: The amount of time Sildenafil ratiopharm takes to work varies from person to person, but it normally takes between half an hour and one hour.
Croatian: Vrijeme potrebno za početak djelovanja Sildenafil ratiopharma razlikuje se od osobe do osobe, ali se obično kreće između pola sata i jednog sata.
English: In clinical trials sildenafil was administered to more than 8,000 patients aged 19-87.
Croatian: U kliničkim ispitivanjima, sildenafil je primijenjen kod više od 8000 bolesnika u dobi 19-87 godina.
English: Therefore sexual stimulation is required in order for sildenafil to produce its intended beneficial pharmacological effects.
Croatian: Stoga je seksualna stimulacija neophodna kako bi sildenafil proizveo svoje željene povoljne farmakološke učinke.
English: In addition, physicians should advise patients what to do in the event of postural hypotensive symptoms.
Croatian: Pored toga, liječnici trebaju savjetovati bolesnike što učiniti u slučaju pojave simptoma posturalne hipotenzije.
English: The recommended dose is 50 mg taken as needed approximately one hour before sexual activity.
Croatian: Preporučena doza iznosi 50 mg i uzima se po potrebi približno jedan sat prije spolne aktivnosti.
English: These reports included dizziness and light-headedness, but not syncope.
Croatian: Ta izvješća obuhvaćala su omaglicu i nesvjesticu, ali ne sinkopu.
English: The mean absolute oral bioavailability is 41% (range 25-63%).
Croatian: Srednja apsolutna oralna bioraspoloživost iznosi 41% (raspon 25-63%).
English: If you are taking riociguat or are unsure tell your doctor.
Croatian: Ako uzimate riociguat ili niste sigurni, obratite se svom liječniku.
English: It reduces the action of the natural chemical in your body, which makes erections go away.
Croatian: Smanjuje djelovanje prirodne kemijske tvari u tijelu, koja dovodi do slabljenja erekcije.
English: Therefore sildenafil should be administered to these patients only after careful benefit-risk assessment.
Croatian: Stoga sildenafil treba primjenjivati u takvih bolesnika samo nakon pažljive procjene koristi i rizika.
English: This medicine will only help you to get an erection if you are sexually stimulated.
Croatian: Ovaj lijek će Vam pomoći u postizanju erekcije jedino ako ste seksualno stimulirani.
English: Swallow the film-coated tablet whole with a glass of water.
Croatian: Filmom obloženu tabletu progutajte cijelu s čašom vode.
English: Your doctor should in that case carefully check whether your heart can take the additional strain of having sex.
Croatian: Liječnik će u tom slučaju pažljivo provjeriti može li Vaše srce podnijeti dodatni napor, odnosno spolni odnos.
English: Mean pulmonary systolic blood pressure decreased by 9%.
Croatian: Srednji pulmonalni sistolički krvni tlak se snizio za 9%.
English: If you are taking one of these medicines, your doctor may start you on the lowest dose (25 mg) of Sildenafil ratiopharm.
Croatian: Ako uzimate neki od tih lijekova, liječnik Vam za početak može propisati najnižu dozu (25 mg) lijeka Sildenafil ratiopharm.
English: Tell your doctor or pharmacist if you are already taking riociguat.
Croatian: Obavijestite svog liječnika ili ljekarnika ako već uzimate riociguat.
English: In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance.
Croatian: U slučaju erekcije koja traje duže od 4 sata, bolesnik treba odmah zatražiti liječničku pomoć.
English: Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have greater effects.
Croatian: Očekuje se da bi jači CYP3A4 inhibitori kao što su ketokonazol i itrakonazol imali veće učinke.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti, reproduktivne i razvojne toksičnosti.
English: Because not all adverse reactions are reported to the Marketing Authorisation Holder and included in the safety database, the frequencies of these reactions cannot be reliably determined.
Croatian: S obzirom da sve nuspojave nisu prijavljene nositelju odobrenja i nisu uključene u bazu podataka o sigurnosti primjene lijeka, učestalost tih nuspojava nije moguće pouzdano odrediti.
English: Pharmacokinetics in special patient groups Elderly
Croatian: Farmakokinetika u posebnim skupinama bolesnika
English: In the natural setting, i.e. with sexual stimulation, it restores impaired erectile function by increasing blood flow to the penis.
Croatian: U prirodnim uvjetima, tj. uz seksualnu stimulaciju, ponovno uspostavlja narušenu erektilnu funkciju povećavajući dotok krvi u penis.
English: Taking Sildenafil ratiopharm together with some medicines may lead to problems.
Croatian: Uzimanje lijeka Sildenafil ratiopharm zajedno s nekim lijekovima može uzrokovati određene probleme.
English: Plasma concentrations of this metabolite are approximately 40% of those seen for sildenafil.
Croatian: Koncentracije ovog metabolita u plazmi iznose približno 40% od onih opaženih za sildenafil.
English: Cardiovascular risk factors
Croatian: Čimbenici kardiovaskularnog rizika
English: In controlled clinical trials, the discontinuation rate due to sildenafil was low and similar to placebo.
Croatian: U kontroliranim kliničkim ispitivanjima, stopa odustalih zbog sildenafila bila je niska i slična placebu.
English: If you have an erection, which lasts for more than 4 hours, you should contact a doctor immediately.
Croatian: Ako imate erekciju, koja traje dulje od 4 sata, odmah se morate javiti liječniku.
English: - A sudden decrease or loss of vision - this occurs rarely.
Croatian: Iznenadno slabljenje ili gubitak vida - javlja se rijetko.
English: No studies on the effects on the ability to drive and use machines have been performed.
Croatian: Ispitivanja učinaka na sposobnost upravljanja vozilima i rada sa strojevima nisu provedena.
English: Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity.
Croatian: Prije početka bilo kojeg liječenja erektilne disfunkcije, liječnici moraju uzeti u obzir kardiovaskularni status svojih bolesnika jer postoji određeni stupanj rizika za srce koji je povezan sa spolnom aktivnošću.
English: It is not possible to determine whether these events were directly related to Sildenafil ratiopharm.
Croatian: Nije moguće odrediti jesu li te nuspojave bile izravno povezane s lijekom Sildenafil ratiopharm.
English: - if you have certain rare inherited eye diseases (such as retinitis pigmentosa).
Croatian: - ako imate određene rijetke nasljedne bolesti oka (kao što je retinitis pigmentosa).
English: These medicines are often used to relieve the symptoms of chest pain (angina pectoris).
Croatian: Ti se lijekovi često primjenjuju za ublažavanje simptoma boli u prsima (angina pektoris).
English: This medicine might make some people feel dizzy or affect their vision or hearing.
Croatian: Ovaj lijek može u nekih ljudi izazvati omaglicu ili utjecati na vid ili sluh.