FrancophonIA/ELRC3.0 huggingface dataset:
English: Regarding safety, overall the side effects were considered manageable.
Croatian: S obzirom na sigurnost lijeka, smatra se da se nuspojave općenito mogu kontrolirati.
English: Jardiance was also shown to reduce cardiovascular events in patients with type 2 diabetes who already had cardiovascular disease.
Croatian: Usto, pokazalo se da se primjenom lijeka Jardiance smanjuje učestalost kardiovaskularnih događaja kod bolesnika s dijabetesom tipa 2 koji su već imali kardiovaskularnu bolest.
English: How does Jardiance work?
Croatian: Kako djeluje Jardiance?
English: For practical information about using Jardiance, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Jardiance bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Modest but clinically meaningful reductions in HbA1c were also seen when Jardiance was added to other medicines.
Croatian: HbA1c uočena su također kada se Jardiance dodavao drugim lijekovima.
English: The active substance in Jardiance, empagliflozin, works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Croatian: Djelatna tvar u lijeku Jardiance, empagliflozin, djeluje inhibirajući protein u bubrezima koji se naziva kotransporter natrija i glukoze 2 (SGLT2).
English: How is Jardiance used?
Croatian: Kako se Jardiance koristi?
English: concluded that Jardiance was shown to be effective in lowering blood glucose levels in patients with type 2 diabetes, when given alone or in combination with other diabetes medicines with different mechanisms of action.
Croatian: CHMP je zaključio da se lijek Jardiance pokazao djelotvornim u snižavanju razine glukoze u krvi u bolesnika s dijabetesom tipa 2 kada se uzima kao monoterapija ili u kombinaciji s drugim lijekovima protiv dijabetesa s različitim mehanizmima djelovanja.
English: For the full list of all side effects and restrictions with Jardiance, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Jardiance potražite u uputi o lijeku.
English: All the studies showed a modest but clinically meaningful decrease in HbA1c with Jardiance compared with placebo: in the study investigating use of Jardiance without other medicines, the reduction in HbA1c was 0.74% more than placebo with the 10 mg dose and 0.85% more than placebo with the 25 mg dose.
Croatian: HbA1c iznosilo je 0,74 % više nego uz primjenu placeba u dozi od 10 mg te 0,85 % više nego uz primjenu placeba u dozi od 25 mg.
English: By blocking the action of SGLT2, empagliflozin causes more glucose to be removed via the kidney, through the urine, thereby reducing the levels of glucose in the blood.
Croatian: Inhibirajući djelovanje proteina SGLT2 empagliflozin omogućuje izlučivanje veće količine glukoze mokraćom, preko bubrega, čime se snižava razina glukoze u krvi.
English: As blood is filtered by the kidneys, SGLT2 stops glucose in the bloodstream from being passed out into the urine.
Croatian: Kako se krv pročišćava u bubrezima, protein SGLT2 onemogućuje da glukoza iz krvotoka prijeđe u mokraću.
English: In addition, beneficial reductions in weight and blood pressure were seen in patients treated with Jardiance.
Croatian: U bolesnika liječenih lijekom Jardiance također je uočeno korisno smanjivanje tjelesne težine i krvnoga tlaka.
English: 2 years.
Croatian: 2 godine
English: The following side effects could be very serious:
Croatian: Sljedeće bi nuspojave mogle biti vrlo ozbiljne:
English: Tell the doctor if you have any of the following:
Croatian: Recite liječniku ako imate bilo što od navedenog:
English: c Nominal p-value.
Croatian: c Nominalna p-vrijednost.
English: Sucralose (E955)
Croatian: Sukraloza (E955)
English: The medicine may be harmful for those suffering from alcoholism.
Croatian: Lijek bi mogao biti štetan za osobe koje pate od alkoholizma.
English: This leaflet was last revised in .
Croatian: Ova je uputa zadnji puta revidirana u.
English: You may start on a low dose that your doctor gradually increases over time.
Croatian: Možete početi s niskom dozom koju će Vaš liječnik s vremenom postupno povećavati.
English: In this population, efficacy has not been established.
Croatian: U ovoj populaciji, djelotvornost nije utvrđena.
English: No effect
Croatian: Nema učinka
English: Maintenance Dose Maximum Recommended Dose
Croatian: Doza održavanja Maksimalna preporučena doza
English: Ask your pharmacist about how to throw away any medicine that you no longer use.
Croatian: Pitajte svog ljekarnika kako baciti lijekove koje više ne koristite.
English: In addition, monitoring of plasma concentrations should be considered.
Croatian: Pored toga, treba se razmotriti praćenje koncentracija u plazmi.
English: Ethanol in the formulation
Croatian: Etanol u formulaciji
English: Routine Monitoring:
Croatian: Rutinsko praćenje:
English: The pack contains the following items
Croatian: Pakiranje sadrži sljedeće predmete:
English: - you notice unusual changes in your mood or behaviour or have thoughts of harming or killing yourself.
Croatian: - ako primijetite neobične promjene u svom raspoloženju ili ponašanju ili ako imate primisli o ozljeđivanju ili samoubojstvu.
English: The mechanism of this risk is not known, and the available data do not exclude the possibility of an increased risk for cannabidiol.
Croatian: Mehanizam ovog rizika nije poznat, a dostupni podaci ne isključuju mogućnost povećanog rizika za kanabidiol.
English: The increase was reversible in healthy adults.
Croatian: Povećanje je kod zdravih odraslih osoba bilo reverzibilno.
English: It can be used in adults, adolescents and children of at least 2 years of age.
Croatian: Može se primjenjivati kod odraslih osoba, adolescenata i djece dobi od najmanje 2 godine.
English: Take the next dose at your regular time.
Croatian: Sljedeću dozu uzmite u redovito vrijeme.
English: If your liver is not working properly, your treatment may need to be stopped.
Croatian: Ako Vam jetra ne funkcionira pravilno, Vaše će se liječenje možda morati prekinuti.
English: Biotransformation and elimination
Croatian: Biotransformacija i eliminacija
English: What is in this leaflet
Croatian: Što se nalazi u ovoj uputi?
English: Do not throw away any medicine in the wastewater or household waste.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: Experience with doses higher than the recommended therapeutic dose is limited.
Croatian: Iskustvo s dozama većima od preporučene terapijske doze je ograničeno.
English: There have not been any clinical studies formally investigating this interaction.
Croatian: Nisu provedena formalna klinička ispitivanja koja bi ispitala ovu interakciju.
English: Do not push the plunger forcefully or direct the medicine to the back of the mouth or throat.
Croatian: Nemojte na silu gurati klip ili usmjeravati lijek u stražnji dio usta ili u grlo.
English: Shake off any water from both parts and allow them to dry in the air until the next use.
Croatian: Istresite preostalu vodu iz oba dijela i pustite da se osuše na zraku do sljedeće uporabe.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzimali ili biste mogli uzeti bilo koje druge lijekove.
English: Increased appetite
Croatian: Povećani apetit
English: In this case, keep careful track of how many times you have filled the syringe (e.g., by marking off each 5 ml dose, respectively) so that you take the right dose.
Croatian: U tom slučaju pažljivo pratite koliko ste puta napunili štrcaljku (npr. bilježenjem svake doze od 5 ml) kako biste uzeli ispravnu dozu.
English: Contact your doctor or go to a hospital straight away (See section 4).
Croatian: Obratite se svom liječniku ili odmah otiđite u bolnicu (pogledajte dio 4).
English: This will help protect the environment.
Croatian: Ove će mjere pomoći u očuvanju okoliša.
English: There was a significant positive correlation between the derived AUC of cannabidiol and the probability of a ≥ 50% response.
Croatian: Postojala je značajna pozitivna korelacija između deriviranog AUC kanabidiola i vjerojatnosti odgovora od ≥ 50%.
English: The apparent volume of distribution was high in healthy volunteers at 20,963 L to 42,849 L and greater than total body water, suggesting a wide distribution of cannabidiol.
Croatian: Prividni volumen distribucije je bio visok u zdravih dobrovoljaca pri 20 963 l do 42 849 l i veći od ukupne vode u tijelu, što sugerira široku distribuciju kanabidiola.
English: Read all of this leaflet carefully before you or the patient start taking this medicine because it contains important information for you or the patient
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži važne podatke za Vas ili bolesnika.
English: Somnolence and sedation
Croatian: Somnolencija i sedacija
English: Dosing should be resumed at the existing treatment schedule.
Croatian: Doziranje treba nastaviti prema postojećem rasporedu liječenja.
English: For any information about this medicine, please contact the medical information representative of the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
English: a average increases of 47% in AUC and 73% in Cmax b based on Cmax and AUC
Croatian: a prosječni porast 47% za AUC i 73% za Cmax b na temelju Cmax i AUC-a
English: The frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Croatian: Učestalost je definirana kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100).
English: Your doctor and pharmacist will tell you how much (number of ml) Epidyolex to take each day, how many times a day you should take it and which syringe you should use for your dose (1 ml or 5 ml).
Croatian: Vaš liječnik i ljekarnik će Vam reći koliko (broj ml) Epidyolexa uzeti svakog dana, koliko puta dnevno ga trebate uzeti i koju štrcaljku da upotrijebite za svoju dozu (1 ml ili 5 ml).
English: Your doctor or pharmacist will let you know which syringe to use depending on the dose that has been prescribed.
Croatian: Vaš će Vam liječnik ili ljekarnik reći koju štrcaljku da upotrebljavate, ovisno o dozi koja je propisana.
English: Epidyolex contains refined sesame oil which may rarely cause severe allergic reactions.
Croatian: Epidyolex sadrži rafinirano sezamovo ulje koje rijetko može uzrokovati teške alergijske reakcije.
English: Intensified Monitoring:
Croatian: Intenzivirano praćenje:
English: The mechanism of this interaction remains unknown.
Croatian: Mehanizam ove interakcije ostaje nepoznat.
English: Continue to use the medicine as normal.
Croatian: Nastavite primjenjivati lijek na uobičajen način.
English: If cannabidiol has to be discontinued, the dose should be decreased gradually.
Croatian: Ako se uzimanje kanabidiola mora prekinuti, dozu treba smanjivati postupno.
English: Do not take Epidyolex - if you are allergic to cannabidiol or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Epidyolex - ako ste alergični na kanabidiol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: The doctor will explain how to gradually stop taking Epidyolex.
Croatian: Liječnik će objasniti kako postupno prestati s uzimanjem Epidyolexa.
English: Pharmacokinetics in special patient groups
Croatian: Farmakokinetika u posebnim skupinama bolesnika
English: If the solution in the bottle has turned cloudy, this doesn't change how well it works.
Croatian: Ako se tekućina u bočici zamuti, to ne mijenja način na koji djeluje.
English: In the case of more than 7 days' missed doses, re-titration to the therapeutic dose should be made.
Croatian: U slučaju da se propuste doze za više od 7 dana, treba provesti ponovnu titraciju do terapijske doze.
English: If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this 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 ovaj lijek.
English: The safety and efficacy of cannabidiol in children aged 6 months to 2 years have not yet been established.
Croatian: Sigurnost i djelotvornost kanabidiola u djece u dobi od 6 mjeseci do 2 godine nisu još ustanovljene.
English: Irritability, Insomnia, Aggression, Abnormal behaviour, Agitation
Croatian: Razdražljivost, nesanica, agresivnost, neuobičajeno ponašanje, agitacija
English: Reversibility was not assessed in studies in LGS and DS.
Croatian: Reverzibilnost nije ocijenjena u ispitivanjima za LGS i DS.
English: One 100 ml bottle
Croatian: Jedna bočica od 100 ml
English: If you have these thoughts at any time, contact your doctor
Croatian: Ako imate ovakve misli u bilo kojem trenutku, obratite se svom liječniku.
English: Use within 8 weeks after first opening the bottle.
Croatian: Primijeniti u roku od 8 tjedana od prvog otvaranja bočice.
English: Juvenile toxicity
Croatian: Juvenilna toksičnost
English: Patients with prolonged elevations of serum transaminases should be evaluated for other possible causes.
Croatian: Bolesnike s dugotrajno povišenim serumskim transaminazama treba procijeniti glede drugih mogućih uzroka.
English: Contact your doctor or go to a hospital straight away.
Croatian: Odmah se javite svom liječniku ili otiđite u bolnicu.
English: Other CNS depressants, including alcohol, can potentiate the somnolence and sedation effect.
Croatian: Drugi depresori CNS-a, uključujući alkohol, mogu pojačati učinak somnolencije i sedacije.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama su pokazala reproduktivnu toksičnost (vidjeti dio 5.3).
English: If you miss many doses, please talk to your doctor about the correct dose to take.
Croatian: Ako propustite više doza, razgovarajte sa svojim liječnikom o ispravnoj sljedećoj dozi.
English: In the event of overdose the patient should be observed and appropriate symptomatic treatment given, including monitoring of vital signs.
Croatian: U slučaju predoziranja bolesnika treba promatrati i pružiti mu odgovarajuće liječenje simptoma, uključujući praćenje vitalnih znakova.
English: Suicidal behaviour and ideation
Croatian: Suicidalno ponašanje i suicidalne primisli
English: In vitro, > 94% of cannabidiol and its phase I metabolites were bound to plasma proteins, with preferential binding to human serum albumin.
Croatian: In vitro, > 94% kanabidiola i njegovih metabolita faze I se vezalo za proteine plazme s preferencijalnim vezivanjem na humani serumski albumin.
English: In some cases, the decreased weight was reported as an adverse event (see the table above).
Croatian: U nekim je slučajevima gubitak tjelesne težine prijavljen kao štetan događaj (pogledati gornju tablicu).
English: In the case of one or more missed doses, the missed doses should not be compensated.
Croatian: U slučaju jedne ili više preskočenih doza, preskočenu dozu ne treba nadoknađivati.
English: If there is an air bubble in the syringe, push the liquid back into the bottle whilst keeping the bottle upside down, and repeat Step 5 until the bubble has gone.
Croatian: Ako u štrcaljki ima mjehurića zraka, vratite tekućinu natrag u bočicu dok držite bočicu naopako, te ponavljajte korak 5 dok mjehurići ne nestanu.
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics; ATC code: N03AX24
Croatian: Farmakoterapijska skupina: antiepileptici, drugi antiepileptici; ATK oznaka: N03AX24
English: The adaptor could come off and cause choking if it is not fully inserted.
Croatian: Adapter može skliznuti i dovesti do gušenja ako nije do kraja umetnut.
English: The mechanism has not been determined.
Croatian: Mehanizam nije utvrđen.
English: (See also section 3, How to take Epidyolex).
Croatian: (Pogledajte i dio 3, Kako uzimati Epidyolex).
English: Compared to dronabinol (synthetic THC) and alprazolam, cannabidiol has low abuse potential.
Croatian: U usporedbi s dronabinolom (sintetički THC) i alprazolamom, kanabidiol ima nizak potencijal za zloporabu.
English: Each study consisted of a 4-week baseline period, a 2-week titration period and a 12-week maintenance period.
Croatian: Svako se ispitivanje sastojalo od početnog razdoblja od 4 tjedna, razdoblja titracije od 2 tjedna i razdoblja održavanja od 12 tjedana.
English: A no-effect dose was not established.
Croatian: Doza bez učinka nije utvrđena.
English: The elevations typically occur in the first two months of treatment initiation; however, there were cases observed up to 18 months after initiation of treatment, particularly in patients taking concomitant valproate.
Croatian: Povišenja se obično pojavljuju u prva dva mjeseca nakon početka liječenja; no bilo je slučajeva u kojima su uočena do 18 mjeseci nakon početka liječenja, osobito kod bolesnika koji istovremeno uzimaju valproat.
English: Patients should be advised not to drive or operate machinery until they have gained sufficient experience to gauge whether it adversely affects their abilities (see section 4.8).
Croatian: Bolesnicima treba savjetovati da ne voze i ne upravljaju strojevima dok ne steknu dovoljno iskustva kako bi mogli procijeniti ima li to nepovoljne učinke na njihove sposobnosti (vidjeti dio 4.8).
English: Increased systemic levels of these active substances may lead to enhanced pharmacological effects and to an increase in adverse drug reactions.
Croatian: Povećane sistemske razine ovih aktivnih tvari mogu dovesti do pojačanih farmakoloških učinaka i povećanja broja nuspojava.
English: As a precautionary measure, cannabidiol should not be used during pregnancy unless the potential benefit to the mother clearly outweighs the potential risk to the foetus.
Croatian: Kao mjeru opreza, kanabidiol ne bi trebalo primjenjivati tijekom trudnoće, osim ako moguća korist za majku jasno nadjačava mogući rizik za fetus.
English: Talk to your doctor about driving, using machines or when children undertake activities such as cycling or other sports, because you may feel sleepy after taking this medicine.
Croatian: Razgovarajte sa svojim liječnikom o vožnji, uporabi strojeva ili dječjim aktivnostima, poput vožnje bicikla i drugih sportova, jer biste se Vi ili bolesnik nakon uzimanja lijeka mogli osjećati pospano.
English: Embryofoetal mortality was observed at the high dose, with no treatment-related effects on implantation loss at the low or mid doses.
Croatian: Embriofetalni mortalitet je uočen pri visokim dozama, bez s liječenjem povezanih učinaka na gubitak implantata pri niskim i srednjim dozama.
English: Following the directions from the doctor or pharmacist, the bag containing the other syringes and adapter should be discarded from the pack unless your doctor or pharmacist tells you to keep both syringes until your final dose has been reached.
Croatian: Prema uputama liječnika ili ljekarnika vrećicu s ostalim štrcaljkama i adapterom treba baciti iz pakiranja, osim ako Vam Vaš liječnik ili ljekarnik kaže da sačuvate obje štrcaljke dok se ne postigne Vaša konačna doza.
English: - if your doctor determines that you have certain abnormal liver blood tests.
Croatian: - ako liječnik utvrdi da imate određena odstupanja u nalazima iz krvi za jetru.
English: Do not reduce the dose or stop this medicine unless the doctor tells you to.
Croatian: Nemojte smanjivati dozu ili prekinuti uzimanje lijeka osim ako Vam tako kaže liječnik.
English: Each Epidyolex carton is supplied with:
Croatian: Svako se kartonsko pakiranje Epidyolexa isporučuje s:
English: Tell your doctor if you have liver problems because the doctor may need to adjust the dose.
Croatian: Recite liječniku ako imate problema s jetrom, jer će on možda trebati prilagoditi dozu.
English: Genotoxicity studies have not detected any mutagenic or clastogenic activity.
Croatian: Ispitivanja genotoksičnosti nisu otkrila mutagenu niti klastogenu aktivnost.
English: Make sure the oral syringe is completely dry before the next use, or it could make the solution appear cloudy if water gets in the bottle.
Croatian: Uvjerite se da je štrcaljka za usta potpuno suha prije sljedeće uporabe, jer bi se tekućina mogla zamutiti ako voda dospije u bočicu.
English: Epidyolex must not be given to children under the age of 2 years, since there is no information on use in children below this age.
Croatian: Epidyolex se ne smije davati djeci mlađoj od 2 godine, jer nema informacija o primjeni u djece mlađe dobi.
English: Upon changes in cannabidiol dose above 10 mg/kg/day or changes in medicinal products (dose change or additions) that are known to impact the liver, this monitoring schedule should be restarted.
Croatian: Nakon promjene doze kanabidiola iznad 10 mg/kg/dan ili promjene u lijekovima (promjena doze ili dodaci) za koje je poznato da utječu na jetru, ovaj raspored praćenja treba krenuti ispočetka.
English: Do not place the oral syringe in a dishwasher.
Croatian: Štrcaljku za usta nemojte stavljati u perilicu posuđa.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Croatian: DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
English: If you have any solution left in the bottle more than 8 weeks after it was first opened, you should not use it.
Croatian: Ako u bočici još imate tekućine 8 tjedana nakon prvog otvaranja, ne biste je trebali upotrebljavati.
English: Very common side effects (may affect more than 1 in 10 people):
Croatian: Vrlo česte nuspojave (mogu se pojaviti u više od 1 na 10 osoba):
English: You should not drive, use machines or take part in activities that require you to be alert and have fine control, until it is established that your ability to perform such activities is not affected.
Croatian: Ne smijete voziti, upotrebljavati strojeve ili sudjelovati u aktivnostima koje zahtijevaju budnost i finu kontrolu dok se ne utvrdi kako Vaša sposobnost za obavljanje takvih aktivnosti nije smanjena.
English: Cannabidiol does not exert its anticonvulsant effect through interaction with cannabinoid receptors.
Croatian: Kanabidiol ne ispoljava svoj antikonvulzivni učinak kroz interakciju s receptorima kanabinoida.
English: The DS population in studies GWPCARE2 and GWPCARE1 was predominantly paediatric patients, with only 5 adult patients who were 18 years old (1.6%), and therefore limited efficacy and safety data were obtained in the adult DS population.
Croatian: DS populacija u ispitivanjima GWPCARE2 i GWPCARE1 su bili uglavnom pedijatrijski bolesnici, uz samo 5 odraslih bolesnika koji su imali 18 godina (1,6%), pa su tako podaci o djelotvornosti i sigurnosti dobiveni od odrasle DS populacije ograničeni.
English: Overall
Croatian: Ukupno
English: Do not start or stop other medicines without talking to your doctor or pharmacist.
Croatian: Nemojte prekidati ili počinjati s uzimanjem drugih lijekova bez razgovora sa svojim liječnikom ili ljekarnikom.
English: - Epidyolex makes you feel sleepy.
Croatian: - Epidyolex Vas može učiniti pospanima.
English: In clinical trials, cannabidiol discontinuation was achieved by reducing the dose by approximately 10% per day for 10 days (see section 4.4).
Croatian: U kliničkim je ispitivanjima prekid uzimanja kanabidiola ostvaren smanjivanjem doze za oko 10% dnevno tijekom 10 dana (vidjeti dio 4.4).
English: Drop seizures were defined as atonic, tonic, or tonic-clonic seizures that led or could have led to a fall or injury.
Croatian: Astatski napadaji su definirani kao atonički, tonički ili toničko-klonički napadaji koji su vodili ili mogli dovesti do pada ili ozljede.