FrancophonIA/ELRC3.0 huggingface dataset:
English: Diacomit is an anti-epileptic medicine that contains the active substance stiripentol.
Croatian: Diacomit je antiepileptik koji sadrži djelatnu tvar stiripentol.
English: Because the number of patients with SMEI is low, the disease is considered ‘rare', and Diacomit was designated as an ‘orphan medicine' (a medicine used in rare diseases) on 5 December 2001.
Croatian: Budući da je broj bolesnika sa SMEI nizak, dotična se bolest smatra „rijetkom” te se Diacomit označava kao lijek za liječenje rijetkih bolesti od 5. prosinca 2001.
English: The full EPAR for Diacomit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Diacomit nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What is the risk associated with Diacomit?
Croatian: Koji su rizici povezani s lijekom Diacomit?
English: Diacomit must not be used in patients who have had psychoses (a serious mental state with a distorted sense of reality) with attacks of delirium (a mental state with confusion, excitement, restlessness and hallucinations).
Croatian: Diacomit se ne smije koristiti u bolesnika koji imaju psihoze (ozbiljno mentalno stanje poremećenog osjećaja za stvarnost) s napadajima delirija (metalnog stanja zbunjenosti, uzbuđenja, nemirnosti i halucinacija).
English: For more information about treatment with Diacomit, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Diacomit pročitajte u uputama o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: The studies compared Diacomit capsules or sachets with placebo (a dummy treatment), when they were added to the children's existing treatment with clobazam and valproate.
Croatian: Ispitivanja su usporedile kapsule ili vrećice lijeka Diacomit s placebom (lažnim liječenjem), kada su se isti dodavali u postojeće liječenje djece s klobazamom i valproatom.
English: Diacomit is used in children with a very rare type of epilepsy called ‘severe myoclonic epilepsy in infancy' (SMEI), also known as Dravet's syndrome.
Croatian: Diacomit se koristi u djece s vrlo rijetkim tipom epilepsije naziva „teška mioklona epilepsija djetinjstva” (SMEI), koja je poznata i pod nazivom Dravetov sindrom.
English: It decided that Diacomit's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Povjerenstvo je odlučilo da koristi od lijeka Diacomit nadmašuju s njim povezane rizike i preporučilo je da se izda odobrenje za stavljanje lijeka u promet.
English: Why has Diacomit been approved?
Croatian: Zašto je lijek Diacomit odobren?
English: Diacomit is used as an add-on to clobazam and valproate (other anti-epileptic medicines) to treat generalised tonic-clonic seizures (major fits, including loss of consciousness) when these are not adequately controlled with clobazam and valproate.
Croatian: Diacomit se koristi kao dodatni lijek uz terapiju klobazamom i valproatom (drugi antiepileptici) za liječenje generaliziranih refraktornih toničko-kloničkih napadaja (velikih napadaja, uključujući i gubitak svijesti) kada se grčevi ne mogu na odgovarajući način kontrolirati primjenom klobazama i valproata.
English: It is also known to amplify the effects of other anti-epileptic medicines and to slow down the rate at which they are broken down by the liver.
Croatian: Smatra se da pojačava djelovanje drugih antiepileptika te usporava brzinu kojom jetra razgrađuje ove lijekove.
English: What is Diacomit?
Croatian: Što je Diacomit?
English: The exact way in which stiripentol, the active substance in Diacomit, acts as an anti-epileptic medicine is not fully known.
Croatian: Nije u potpunosti utvrđen točan način djelovanja stiripentola, djelatne tvari lijeka Diacomit, koji djeluje kao antiepileptik.
English: What benefit has Diacomit shown during the studies?
Croatian: Koje su koristi lijeka Diacomit dokazane u ispitivanjima?
English: What is Diacomit used for?
Croatian: Za što se Diacomit koristi?
English: For the full list of all side effects reported with Diacomit, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Diacomit, potražite u uputi o lijeku.
English: How does Diacomit work?
Croatian: Kako djeluje Diacomit?
English: How is Diacomit used?
Croatian: Kako se Diacomit koristi?
English: See the package leaflet for the full list of restrictions.
Croatian: Potpuni popis ograničenja potražite u uputi o lijeku.
English: How has Diacomit been studied?
Croatian: Kako se Diacomit ispitivao?
English: Do not take a smaller amount.
Croatian: Nemojte uzeti manju količinu.
English: This will usually take about two minutes.
Croatian: Za to je obično potrebno oko dvije minute.
English: In particular:
Croatian: Osobito:
English: - This medicine has been prescribed for you only.
Croatian: Ovaj je lijek je propisan samo Vama.
English: The frequency of these events is currently not known:
Croatian: Učestalost tih nuspojava trenutno je nepoznata:
English: Plasma protein binding is on average 85-90%.
Croatian: Vezanje za proteine plazme u prosjeku je 85-90 %.
English: In case of short-term overdose no emergency medical treatment is required.
Croatian: U slučaju kratkotrajnog predoziranja nije potrebno hitno medicinsko liječenje.
English: Keep taking your medicine until your doctor tells you to stop, even if you feel better.
Croatian: Nastavite uzimati lijek sve dok Vam liječnik ne kaže da prestanete, čak i ako se osjećate bolje.
English: Jorveza with food and drink
Croatian: Jorveza s hranom i pićem
English: Press it gently against the roof of your mouth with your tongue until it has dissolved completely (this usually takes about two minutes).
Croatian: Lagano je pritisnite jezikom o nepce sve dok se potpuno ne otopi (za to je obično potrebno oko 2 minute).
English: The effects of these illnesses can be much more severe during treatment with this medicine.
Croatian: Učinci tih bolesti mogu biti puno teži tijekom liječenja ovim lijekom.
English: In case your symptoms do not get better in the first 6 weeks of treatment, you may need to take this medicine for up to 6 more weeks.
Croatian: U slučaju da Vam se simptomi ne poboljšaju u prvih 6 tjedana liječenja, možda ćete trebati uzimati ovaj lijek još 6 tjedana.
English: The symptoms of some infections can be unusual or less noticeable.
Croatian: Simptomi nekih infekcija mogu biti neuobičajeni ili manje primjetni.
English: This will ensure that your medicine works properly.
Croatian: To će osigurati pravilno djelovanje lijeka.
English: Your treatment should last about 6 to 12 weeks.
Croatian: Vaše liječenje bi trebalo trajati oko 6 do 12 tjedana.
English: If you miss a dose, just take the next dose at the usual time.
Croatian: Ako zaboravite jednu dozu, samo uzmite sljedeću dozu u uobičajeno vrijeme.
English: The use of this medicine in children younger than 18 years of age has not yet been studied.
Croatian: Primjena ovog lijeka u djece mlađe od 18 godina još nije ispitana.
English: Other medicines and Jorveza
Croatian: Drugi lijekovi i Jorveza
English: If you take more Jorveza than you should
Croatian: Ako uzmete više Jorveze nego što ste trebali
English: Common: may affect up to 1 in 10 people
Croatian: Često: mogu se javiti u najviše 1 na 10 osoba
English: Take the following precautions during treatment with Jorveza because your immune system may be weakened:
Croatian: Poduzmite sljedeće mjere opreza tijekom liječenja Jorvezom jer Vam imunološki sustav može biti oslabljen:
English: Subsequent treatment should be symptomatic and supportive.
Croatian: Kasnije liječenje je simptomatsko i potporno.
English: The relevance of this to man has not been established.
Croatian: Nije utvrđena relevantnost ovog učinka u ljudi.
English: Speak to your doctor if you want to interrupt or end your treatment early.
Croatian: Javite se svom liječniku ako želite prekinuti ili ranije završiti liječenje.
English: The clinical relevance of these findings to man has not been established (see section 4.6).
Croatian: Klinički značaj ovih nalaza za ljude nije ustanovljen (vidjeti dio 4.6).
English: There should be at least 30 minutes before eating or drinking or performing oral hygiene.
Croatian: Treba proteći najmanje 30 minuta prije jela ili pića ili provođenja oralne higijene.
English: It is important that you do not stop taking your medicine without talking to your doctor.
Croatian: Važno je da ne prestanete uzimati lijek, a da o tome niste razgovarali s liječnikom.
English: − If you know that you are due to have an operation please tell your doctor that you are taking Jorveza.
Croatian: Ako znate da se spremate na operaciju, molimo obavijestite svog liječnika da uzimate Jorvezu.
English: Jorveza may cause typical side effects of corticosteroid medicines and may affect all parts of the body, particularly when you take this medicine at high doses and over a long time (see section 4).
Croatian: Jorveza može uzrokovati nuspojave tipične za kortikosteroidne lijekove koje mogu zahvatiti sve dijelove tijela, osobito kada uzimate ovaj lijek u visokim dozama i kroz dulje vrijeme (pogledajte dio 4).
English: If you have taken too many orodispersible tablets on one occasion, take your next dose as prescribed.
Croatian: Ako ste jednom prilikom uzeli previše raspadljivih tableta za usta, sljedeću dozu uzmite kao što je propisano.
English: Your doctor will decide on the appropriate measures and if it is still all right for you to take this medicine.
Croatian: Liječnik će odlučiti o odgovarajućim mjerama te je li ipak dobro za Vas da uzimate ovaj lijek.
English: Symptoms of infections can be atypical or masked.
Croatian: Simptomi infekcija mogu biti atipični ili maskirani.
English: − If you need to be vaccinated please speak to your doctor first.
Croatian: Ako se trebate cijepiti, molimo prvo razgovarajte s Vašim liječnikom.
English: However, no systematic data are available.
Croatian: Međutim, nema dostupnih sistematski prikupljenih podataka.
English: What Jorveza is and what it is used for
Croatian: Što je Jorveza i za što se koristi
English: Take one orodispersible tablet in the morning and one orodispersible tablet in the evening.
Croatian: Uzmite jednu raspadljivu tabletu za usta ujutro i jednu raspadljivu tabletu za usta navečer.
English: − Keep away from people who have chickenpox or herpes zoster (shingles) if you have not had these infections.
Croatian: - Držite se podalje od osoba koje imaju vodene kozice ili herpes zoster ako nikada niste imali te infekcije.
English: If you have a kidney problem, your doctor will decide if Jorveza is suitable for you.
Croatian: Ako imate problema s bubrezima, liječnik će odlučiti je li Jorveza odgovarajuća za Vas.
English: If you have any of the conditions mentioned above you may be at increased risk of side effects.
Croatian: Ako imate ijedno od gore navedenih stanja, rizik od nuspojava kod Vas može biti povećan.
English: Saluretics
Croatian: Saluretici
English: White, round, biplane orodispersible tablet, with diameter of 7.1 mm and height of 2.2 mm.
Croatian: Bijela, okrugla, plosnata raspadljiva tableta za usta, promjera 7,1 mm i debljine 2,2 mm.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from budesonide therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje / suzdržati se od liječenja budezonidom uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: The treatment with this medicinal product should be initiated by a physician experienced in the diagnosis and treatment of eosinophilic esophagitis.
Croatian: Liječenje ovim lijekom mora započeti liječnik s iskustvom u dijagnosticiranju i liječenju eozinofilnog ezofagitisa.
English: Frequencies are defined as 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) or not known (cannot be estimated from the available data).
Croatian: (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) ili nepoznato (ne može se procijeniti iz dostupnih podataka).
English: This is equivalent to 2.6% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 2,6 % preporučenog maksimalnog dnevnog unosa natrija za odraslu osobu.
English: Tell your doctors that you are taking Jorveza before you have any tests.
Croatian: Obavijestite liječnike da uzimate Jorvezu prije bilo kakvih pretraga.
English: Budesonide had no mutagenic effects in a number of in vitro and in vivo tests.
Croatian: Budezonid nije imao mutagenih učinaka u brojnim in vitro i in vivo testovima.
English: For information about the observed adverse reactions, see section 4.8.
Croatian: Za informacije o opaženim nuspojavama, vidjeti dio 4.8.
English: Concomitant treatment with ketoconazole or other CYP3A4 inhibitors should be avoided (see section 4.5).
Croatian: Treba izbjegavati istodobno liječenje ketokonazolom ili drugim inhibitorima CYP3A4 (vidjeti dio 4.5)
English: Do not take this medicine during pregnancy without checking with your doctor first.
Croatian: Nemojte uzimati ovaj lijek tijekom trudnoće, a da to prethodno niste provjerili s liječnikom.
English: Interference with serological testing
Croatian: Utjecaj na serološko testiranje
English: Some of these medicines may increase the effects of Jorveza and your doctor may wish to monitor you carefully if you are taking these medicines.
Croatian: Neki od tih lijekova mogu povećati učinke Jorveze i ako uzimate te lijekove, liječnik će Vas možda htjeti pažljivo pratiti.
English: EU/1/17/1254/003 EU/1/17/1254/004 EU/1/17/1254/005
Croatian: EU/1/17/1254/001 EU/1/17/1254/002 EU/1/17/1254/003 EU/1/17/1254/004 EU/1/17/1254/005
English: Oestrogens, oral contraceptives
Croatian: Estrogeni, oralni kontraceptivi
English: Do not eat, drink, brush your teeth or rinse your mouth for at least 30 minutes after you have taken the orodispersible tablet.
Croatian: Nemojte jesti, piti, prati zube ili ispirati usta najmanje 30 minuta nakon što ste uzeli raspadljivu tabletu za usta.
English: Contact a doctor if you are in doubt.
Croatian: Obratite se liječniku u slučaju sumnje.
English: What you need to know before you take Jorveza
Croatian: Što morate znati prije nego počnete uzimati Jorvezu
English: Symptoms of fungal infection can be white spots in the mouth and throat and difficulty in swallowing.
Croatian: Simptomi gljivične infekcije mogu biti bijele mrlje u ustima i grlu i otežano gutanje.
English: − Tell your doctor if you have not yet had measles and/or if and when you have received your last vaccination for this disease.
Croatian: - Obavijestite svog liječnika ako do sada niste imali ospice i/ili jeste li i kada ste zadnji put primili cijepivo protiv te bolesti.
English: Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).
Croatian: Jorveza je indicirana za liječenje eozinofilnog ezofagitisa u odraslih (starijih od 18 godina).
English: Place the orodispersible tablet on the tip of your tongue and close your mouth.
Croatian: Stavite raspadljivu tabletu za usta na vrh jezika i zatvorite usta.
English: Patients with hepatic impairment should not be treated (see sections 4.4 and 5.2).
Croatian: Bolesnike s oštećenjem funkcije jetre ne smije se liječiti (vidjeti dijelove 4.4 i 5.2).
English: Budesonide passes in small amounts into the breast milk.
Croatian: Budezonid u malim količinama prelazi u majčino mlijeko.
English: Budesonide had no effect on fertility in rats.
Croatian: Budezonid nije imao učinka na plodnost štakora.
English: Therefore, concomitant use should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side effects, in which case patients should be monitored for systemic corticosteroid side effects.
Croatian: Stoga je potrebno izbjegavati njihovu istodobnu primjenu, osim kada korist nadmašuje povećani rizik od sistemskih nuspojava kortikosteroida, a u tom slučaju je bolesnike potrebno pratiti radi otkrivanja sistemskih nuspojava kortikosteroida.
English: The usual duration of treatment is 6 weeks.
Croatian: Liječenje obično traje 6 tjedana.
English: If you have any liver disease, you should not take Jorveza.
Croatian: Ako imate ikakvu bolest jetre, ne smijete uzimati Jorvezu.
English: Budesonide is excreted in human milk (data on excretion after inhalative use is available).
Croatian: Budezonid se izlučuje u majčino mlijeko (dostupni su podaci o izlučivanju nakon uporabe putem inhalacije).
English: Following administration of Jorveza, budesonide is rapidly absorbed.
Croatian: Nakon primjene Jorveze, budezonid se brzo apsorbira.
English: Do not take this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „EXP“.
English: No such effect has been observed with budesonide and concomitant intake of low-dose combination oral contraceptives.
Croatian: Takav učinak nije opažen uz istodobno uzimanje budezonida i niskodoznih kombiniranih oralnih kontraceptiva.
English: The antibody response to other vaccines may be diminished.
Croatian: Odgovor protutijela na druga cjepiva može oslabljen.
English: Pharmacotherapeutic group: Antidiarrheals, intestinal antiinflammatory/antiinfective agents, corticosteroids acting locally, ATC code: A07EA06
Croatian: Farmakoterapijska skupina: antidijaroici, crijevna protuupalna/antiinfektivna sredstva, kortikosteroidi s lokalnim djelovanjem, ATK oznaka: A07EA06
English: Jorveza should not be used in children and adolescents under 18 years of age.
Croatian: Jorveza se ne smije primjenjivati u djece i adolescenata mlađih od 18 godina.
English: EU/1/17/1254/001 (20 orodispersible tablets) EU/1/17/1254/002 (30 orodispersible tablets) EU/1/17/1254/003 (60 orodispersible tablets) EU/1/17/1254/004 (90 orodispersible tablets) EU/1/17/1254/005 (100 orodispersible tablets)
Croatian: EU/1/17/1254/001 (20 raspadljivih tableta za usta) EU/1/17/1254/002 (30 raspadljivih tableta za usta) EU/1/17/1254/003 (60 raspadljivih tableta za usta) EU/1/17/1254/004 (90 raspadljivih tableta za usta) EU/1/17/1254/005 (100 raspadljivih tableta za usta)
English: − oestrogens (used for hormone replacement therapy or contraception)
Croatian: - estrogene (primjenjuju se kao hormonska nadomjesna terapija ili za kontracepciju)
English: The safety and efficacy of Jorveza in children and adolescents under the age of 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka Jorveza u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: − inflammation of the pancreas, which causes severe pain in the belly and back
Croatian: - upala gušterače, što uzrokuje jaku bol u trbuhu i leđima
English: Pack sizes: 20, 30, 60, 90 or 100 orodispersible tablets.
Croatian: Veličine pakiranja: 20, 30, 60, 90 ili 100 raspadljivih tableta za usta.
English: Systemic effects of glucocorticosteroids
Croatian: Sistemski učinci glukokortikosteroida
English: The following side effects have been reported and are typical with medicines similar to Jorveza (corticosteroids), and can therefore also occur with this medicine.
Croatian: Prijavljene su sljedeće nuspojave koje su tipične uz lijekove slične Jorvezi (kortikosteroidi) te se stoga mogu pojaviti i uz ovaj lijek.
English: Do not take this medicine if you are breast-feeding unless you have checked with your doctor.
Croatian: Nemojte uzimati ovaj lijek ako dojite osim ako to niste provjerili s liječnikom.
English: Jorveza comes in blisters in packs with 20, 30, 60, 90 or 100 orodispersible tablets.
Croatian: Jorveza se isporučuje u blisterima u pakiranjima od 20, 30, 60, 90 ili 100 raspadljivih tableta za usta.
English: The orodispersible tablet should not be taken with liquid or food.
Croatian: Raspadljivu tabletu za usta se ne smije uzimati s tekućinom ili hranom.
English: Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity.
Croatian: Infekcije Supresija upalnog odgovora i imunološkog sustava povećava podložnost infekcijama i njihovu težinu.
English: − if you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Jorvezu - ako ste alergični na budezonid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: The risk of adverse reactions (systemic glucocorticosteroid effects) will be increased.
Croatian: Rizik od nuspojava (sistemskih učinaka glukokortikosteroida) bit će povećan.
English: Jorveza contains the active substance budesonide, a corticosteroid medicine that reduces inflammation.
Croatian: Jorveza sadrži djelatnu tvar budezonid, kortikosteroidni lijek koji smanjuje upalu.
English: Because adrenal function may be suppressed by treatment with budesonide, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values).
Croatian: Budući da liječenje budezonidom može dovesti do supresije funkcije nadbubrežnih žlijezda, poticajni ACTH test koji se koristi za dijagnozu insuficijencije hipofize može dati netočne rezultate (niske vrijednosti).
English: There are few data of pregnancy outcomes after oral administration of budesonide in humans.
Croatian: Postoji malo podataka o ishodima trudnoće nakon oralne primjene budezonida u ljudi.
English: These side effects depend on the duration of treatment, concomitant and previous glucocorticosteroid treatment and the individual sensitivity.
Croatian: Ove nuspojave ovise o trajanju liječenja, istodobnom ili prethodnom liječenju glukokortikosteroidima i osjetljivosti pojedinog bolesnika.
English: CYP3A5 does not contribute significantly to the metabolism of budesonide.
Croatian: CYP3A5 ne pridonosi značajno metabolizmu budezonida.
English: When ketoconazole was administered approximately 12 hours after budesonide, the plasma concentration of budesonide increased approximately 3-fold.
Croatian: Kada se ketokonazol primijenio približno 12 sati nakon budezonida, koncentracija budezonida u plazmi povisila se približno 3 puta.
English: If you have any problem with your kidney or liver, talk to your doctor.
Croatian: Ako imate bilo kakvih problema s bubrezima ili jetrom, obratite se liječniku.
English: If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Croatian: Ako bolesnik ima simptome kao što su zamućen vid ili neke druge poremećaje vida, treba razmotriti potrebu da ga se uputi oftalmologu radi procjene mogućih uzroka, koji mogu uključivati kataraktu, glaukom ili rijetke bolesti, kao što je centralna serozna korioretinopatija (CSCR) koja je zabilježena nakon sustavne i topikalne uporabe kortikosteroida.
English: Because budesonide is not excreted via the kidneys, patients with mild to moderate impairment may be treated with caution with the same doses as patients without renal impairment.
Croatian: Budući da se budezonid ne izlučuje putem bubrega, bolesnike s blagim do umjerenim oštećenjem može se oprezno liječiti istim dozama kao i bolesnike bez oštećenja funkcije bubrega.
English: 20 orodispersible tablets 30 orodispersible tablets 60 orodispersible tablets 90 orodispersible tablets 100 orodispersible tablets
Croatian: 20 raspadljivih tableta za usta 30 raspadljivih tableta za usta 60 raspadljivih tableta za usta 90 raspadljivih tableta za usta 100 raspadljivih tableta za usta
English: Some glucocorticoids have been reported to produce cleft palate in animals.
Croatian: Za neke je glukokortikoide prijavljeno da uzrokuju rascjep nepca u životinja.