FrancophonIA/ELRC3.0 huggingface dataset:
English: Preparations from dried eucalyptus leaf are obtained by comminuting (reducing into tiny pieces) the dried leaves of older branches of the tree, or by using them to produce a tincture (an alcoholic extract of the plant material).
Croatian: Pripravci iz osušenog eukaliptusovog lista dobivaju se usitnjavanjem osušenih listova starijih grana stabla, ili listovi koriste za pripravu tinkture (alkoholnog ekstrakta biljnog materijala).
English: Other information about eucalyptus leaf medicines
Croatian: Ostale informacije o lijekovima koji sadrže eukaliptusov list
English: What are the risks associated with eucalyptus leaf medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže eukaliptusov list?
English: For practical information about using eucalyptus leaf medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Croatian: Za praktične informacije o uporabi lijekova koji sadrže eukaliptusov list bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svom liječniku ili ljekarniku.
English: For more information about treatment with eucalyptus leaf medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekovima koji sadrže eukaliptusov list pročitajte u uputi o lijeku priloženoj uz lijek odnosno obratite se svom liječniku ili ljekarniku.
English: What is eucalyptus leaf?
Croatian: Što je eukaliptusov list?
English: What evidence supports the use of eucalyptus leaf medicines?
Croatian: Koji dokazi potkrjepljuju uporabu lijekova koji sadrže eukaliptusov list?
English: Eucalyptus leaf
Croatian: Eukaliptusov list
English: How are eucalyptus leaf medicines approved in the EU?
Croatian: Kako se u Europskoj uniji odobravaju lijekovi koji sadrže eukaliptusov list?
English: 1 bottle + 1 measuring spoon
Croatian: 1 boca + 1 mjerna žlica
English: Package size mg/ml
Croatian: Veličina pakiranja mg/ml oralna otopina
English: You will hear a click.
Croatian: Čut ćete klik.
English: 26 July 2018
Croatian: 26. srpnja 2018.
English: The injection could take about 15 seconds.
Croatian: Injekcija bi mogla potrajati oko 15 sekundi.
English: Elderly (aged 65 years and over)
Croatian: Stariji (u dobi od 65 godina i više)
English: Your symptoms may return if you stop the treatment.
Croatian: Vaši bi se simptomi mogli vratiti ako prekinete liječenje.
English: This can dry out the medicine.
Croatian: To može isušiti lijek.
English: - Then contact your doctor, who will tell you when you should schedule your next dose.
Croatian: - Zatim se obratite svom liječniku, koji će Vam reći kad trebate planirati svoju sljedeću dozu.
English: Of these, more than 1,300 patients were exposed for at least 12 months.
Croatian: Od toga je više od 1300 bolesnika bilo izloženo najmanje 12 mjeseci.
English: There may be local regulations for disposal.
Croatian: Moguće je da postoje lokalni propisi za odlaganje.
English: Both -2.5
Croatian: oboje -2,5
English: The injections can also be given by another individual who has been appropriately instructed.
Croatian: Injekcije može davati i druga osoba koja je primila odgovarajuće upute.
English: Stomach area (abdomen)
Croatian: Područje trbuha (abdomen)
English: If you need to use the same injection site, just make sure it is not the same spot on that site you used last time.
Croatian: Ako morate upotrijebiti isto mjesto primjene, pazite da to ne bude na istom dijelu mjesta koji ste zadnji put upotrijebili.
English: Single use.
Croatian: Jednokratna uporaba.
English: Choose a different site each time you give yourself an injection.
Croatian: Odaberite drugo mjesto svaki put kad si dajete injekciju.
English: If you have not noticed any treatment effect after 3 months, tell your doctor who will decide whether you should continue treatment.
Croatian: Ako niste primijetili bilo kakav učinak liječenja nakon 3 mjeseca, obavijestite svog liječnika koji će odlučiti hoćete li nastaviti liječenje.
English: Differences from placebo were observed from Month 1 onwards.
Croatian: Razlike u odnosu na placebo opažene su od 1. mjeseca nadalje.
English: The safety and efficacy of Aimovig in children below the age of 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost Aimoviga u djece u dobi ispod 18 godina nisu još ustanovljene.
English: 79.8% completed the entire study out to 52 weeks.
Croatian: 79,8% je završilo cijelo ispitivanje do 52 tjedna.
English: The injection must be administered within 5 minutes.
Croatian: Injekcija se mora primijeniti u roku od 5 minuta.
English: Note: When the injection is completed, the window will turn yellow and you may hear a second click.
Croatian: Napomena: kad je injekcija dovršena, prozorčić će požutjeti i možda ćete čuti drugi klik.
English: Consideration should be given to discontinuing treatment in patients who have shown no response after 3 months of treatment.
Croatian: Treba razmotriti prekid liječenja u bolesnika koji nisu pokazali odgovor nakon 3 mjeseca liječenja.
English: Less than 2% of patients in these studies discontinued due to adverse events.
Croatian: Manje od 2% bolesnika u ovim ispitivanjima je prekinulo ispitivanje zbog štetnih događaja.
English: It has biological activity in cynomolgus monkeys, but this species is not an appropriate model for evaluation of tumorigenic risk.
Croatian: Ima biološku aktivnost u cynomolgus majmuna, ali ta vrsta nije odgovarajući model za ocjenu tumorogenog rizika.
English: Do not give this medicine to children or adolescents (under 18 years old) because the use of Aimovig has not been studied in this age group.
Croatian: Nemojte davati ovaj lijek djeci ili adolescentima (mlađima od 18 godina) zato što primjena Aimoviga nije bila ispitivana u toj dobnoj skupini.
English: 59% of patients completing the study achieved a 50% response in the last month of the study.
Croatian: 59% bolesnika koji su završili ispitivanje postigli su odgovor od 50% u zadnjem mjesecu ispitivanja.
English: Two elimination phases were observed for erenumab.
Croatian: Opažene su dvije faze eliminacije za erenumab.
English: Some patients may benefit from a dose of 140 mg every 4 weeks (see section 5.1).
Croatian: Neki bolesnici mogu imati koristi od doze od 140 mg svaka 4 tjedna (vidjeti dio 5.1).
English: It should also be protected from direct sunlight.
Croatian: Potrebno ju je i zaštititi od izravne sunčeve svjetlosti.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, reproduktivne i razvojne toksičnosti.
English: Apply an adhesive plaster if needed.
Croatian: Stavite flaster ako je potrebno.
English: Gather all materials needed for the injections:
Croatian: Prikupite sve materijale potrebne za injekcije:
English: If you have received more Aimovig than you should or if the dose has been given earlier than it should have been, tell your doctor.
Croatian: Ako ste primili više Aimoviga nego što ste trebali ili ako je doza dana ranije nego što je trebala biti, recite svom liječniku.
English: Use Aimovig exactly as prescribed by your doctor.
Croatian: Primijenite Aimovig točno onako kako je propisao Vaš liječnik.
English: After you remove the pen from the skin, the needle will automatically be covered by the safety guard.
Croatian: Nakon što maknete brizgalicu s kože, iglu će automatski prekriti štitnik.
English: Follow the new schedule exactly as your doctor has told you.
Croatian: Slijedite novi raspored točno onako kako Vam je liječnik rekao.
English: Yellow window (injection complete)
Croatian: Žuti prozorčić (injekcija dovršena)
English: There were also no adverse effects on surrogate markers of fertility (anatomical pathology or histopathology changes in reproductive organs) in these studies.
Croatian: Također nije bilo štetnih učinaka na surogatne markere plodnosti (anatomske patološke ili histopatološke promjene u reproduktivnim organima) u ovim ispitivanjima.
English: Talk to your doctor or pharmacist about proper disposal.
Croatian: Razgovarajte sa svojim liječnikom ili ljekarnikom o pravilnom odlaganju.
English: The outer area of your upper arm can also be used as an injection site, but only if someone else is giving you the injection.
Croatian: Vanjski dio Vaše nadlaktice također se može koristiti kao mjesto za injekciju, ali samo ako Vam netko drugi daje injekciju.
English: Contact your doctor.
Croatian: Obratite se svom liječniku.
English: Clinical studies have demonstrated that the majority of patients responding to therapy showed clinical benefit within 3 months.
Croatian: Klinička su ispitivanja pokazala da je većina bolesnika koja je odgovorila na liječenje imala kliničke koristi u roku od 3 mjeseca.
English: Both
Croatian: oboje
English: After you have cleaned the area, do not touch it again before injecting.
Croatian: Napomena: Nakon što ste očistili područje, nemojte ga ponovo dodirivati prije injekcije.
English: What Aimovig is and what it is used for
Croatian: Što je Aimovig i za što se koristi
English: Efficacy was sustained up to 1 year in the active re-randomisation part of Study 2.
Croatian: Djelotvornost se održala do 1 godine u aktivnom, ponovo randomiziranom dijelu Ispitivanja 2.
English: If you forget to use Aimovig - If you forget an Aimovig dose, take it as soon as possible after you realise.
Croatian: Ako ste zaboravili primijeniti Aimovig - Ako zaboravite uzeti dozu Aimoviga, uzmite je čim prije kad to shvatite.
English: Aimovig is given as an injection under your skin (known as a subcutaneous injection).
Croatian: Aimovig se daje kao injekcija pod kožu (što se naziva supkutanom injekcijom).
English: Do not use Aimovig: - if you are allergic to erenumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Aimovig: - ako ste alergični na erenumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Approximately 41% of patients in the study had medication overuse.
Croatian: Otprilike 41% bolesnika u ispitivanju prekomjerno je upotrebljavalo lijekove.
English: It belongs to a group of medicines called monoclonal antibodies.
Croatian: Pripada skupini lijekova koji se nazivaju monoklonska protutijela.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Croatian: DRUGO(A) POSEBNO (A) UPOZORENJE(A), AKO JE POTREBNO
English: Do not put Aimovig back in the refrigerator once it has been removed.
Croatian: Ne vraćajte Aimovig u hladnjak nakon što je izvađen.
English: Doses up to 280 mg have been administered subcutaneously in clinical studies with no evidence of dose-limiting toxicity.
Croatian: Doze do 280 mg primjenjivane su supkutano u kliničkim ispitivanjima bez dokaza o toksičnosti koja ograničava dozu.
English: No cases of overdose have been reported in clinical studies.
Croatian: Nije bilo slučajeva predoziranja prijavljenih u kliničkim ispitivanjima.
English: The mutagenic potential of erenumab has not been evaluated; however, monoclonal antibodies are not expected to alter DNA or chromosomes.
Croatian: Mutageni potencijal erenumaba nije se ocjenjivao; međutim, ne očekuje se da će monoklonska protutijela promijeniti DNK ili kromosome.
English: For data collection a recall period of 3 months has been used.
Croatian: Za prikupljanje podataka korišteno je razdoblje prisjećanja od 3 mjeseca.
English: For data collection a recall period of 1 month has been used.
Croatian: Za prikupljanje podataka korišteno je razdoblje prisjećanja od 1 mjeseca.
English: Most of the reactions were mild or moderate in severity.
Croatian: Većina reakcija bila je blaga ili umjerena po težini.
English: Talk to your doctor before using Aimovig: - if you have ever had an allergic reaction to rubber latex.
Croatian: Obratite se svom liječniku prije nego primijenite Aimovig: - ako ste ikad imali alergijsku reakciju na gumu lateks.
English: Overall, 39% had failed one or more previous prophylactic pharmacotherapies due to lack of efficacy or poor tolerability.
Croatian: Ukupno, u 39% slučajeva je jedna ili više prethodnih profilaktičkih farmakoterapija bila neuspješna zbog nedostatka djelotvornosti ili slabe podnošljivosti.
English: Clean the injection site with an alcohol wipe and let the skin dry.
Croatian: Očistite mjesto za primjenu injekcije alkoholnom maramicom i pustite da se koža osuši.
English: If you use more Aimovig than you should
Croatian: Ako primijenite više Aimoviga nego što ste trebali
English: Patients with certain major cardiovascular diseases were excluded from clinical studies (see section 5.1).
Croatian: Bolesnici s određenim težim kardiovaskularnim bolestima bili su isključeni iz kliničkih ispitivanja (vidjeti dio 5.1).
English: Inhibition of the effects of CGRP could theoretically attenuate compensatory vasodilation in ischaemic-related conditions.
Croatian: Inhibicija učinaka CGRP-a teoretski bi mogla smanjiti kompenzacijsku vazodilataciju u stanjima povezanima s ishemijom.
English: Treatment should be initiated by physicians experienced in the diagnosis and treatment of migraine.
Croatian: Liječenje treba započeti liječnik s iskustvom u dijagnosticiranju i liječenju migrene.
English: You or your caregiver can give the injection into your abdomen or your thigh.
Croatian: Vi ili Vaš njegovatelj možete dati injekciju u Vaš trbuh ili Vaše bedro.
English: Throughout the dosing period erenumab is predominantly eliminated via a non-specific proteolytic pathway with the effective half-life of 28 days.
Croatian: Tijekom razdoblja doziranja erenumab se pretežno eliminira nespecifičnim proteolitičkim putem s efektivnim poluvremenom od 28 dana.
English: Patients with poorly controlled hypertension or BMI >40 were excluded from Study 1.
Croatian: Bolesnici sa slabo kontroliranom hipertenzijom ili BMI >40 su bili isključeni iz Ispitivanja
English: In contrast with other neuropeptides, CGRP levels have been shown to increase significantly during migraine and return to normal with headache relief.
Croatian: Za razliku od drugih neuropeptida, pokazalo se da se razine peptida CGRP značajno povećavaju tijekom migrene i vraćaju se u normalu s ublažavanjem glavobolje.
English: Aimovig showed similar exercise duration compared to placebo and did not aggravate myocardial ischaemia in these patients.
Croatian: Aimovig je pokazao slično trajanje fizičkog napora u usporedbi s placebom i nije pogoršao ishemiju miokarda u tih bolesnika.
English: At low concentrations, the elimination is predominately through saturable binding to target (CGRP-R), while at higher concentrations the elimination of erenumab is largely through a non-specific proteolytic pathway.
Croatian: Pri niskim koncentracijama eliminacija se uglavnom odvija kroz saturabilno vezanje za ciljni receptor (CGRP-R), dok se pri višim koncentracijama eliminacija erenumaba uglavnom odvija nespecifičnim proteolitičkim putem.
English: Note: Needle is inside.
Croatian: Napomena: Igla je unutra.
English: Not to be sold separately.
Croatian: Nije namijenjen za zasebnu prodaju.
English: Do not stop using Aimovig without talking to your doctor first.
Croatian: Nemojte prestati uzimati Aimovig ako niste prethodno o tome razgovarali sa svojim liječnikom.
English: Do not try to inject Aimovig until this training has been given.
Croatian: Ne pokušavajte ubrizgavati Aimovig dok ne dobijete tu obuku.
English: Afterwards, use of Aimovig could be considered during breast-feeding only if clinically needed.
Croatian: Nakon toga, primjena Aimoviga tijekom dojenja bi se mogla uzeti u obzir samo ako je klinički potrebna.
English: Mean change c
Croatian: Srednja promjena c
English: If it is stored at a higher temperature or for a longer period it must be discarded.
Croatian: Ako se čuva na višoj temperaturi kroz dulji period, mora se baciti.
English: Aimovig may cause skin reactions such as rash or itching which are usually mild.
Croatian: Aimovig može uzrokovati kožne reakcije poput osipa ili svrbeža koje su obično blage.
English: Your doctor or nurse will give you or your caregiver training in the right way to prepare and inject Aimovig.
Croatian: Liječnik ili medicinska sestra obučit će Vas ili Vašeg njegovatelja kako pravilno pripremiti i ubrizgati Aimovig.
English: Step 2: Get ready
Croatian: 2. korak: pripremite se
English: After use
Croatian: Poslije uporabe
English: Pharmacotherapeutic group: Analgetics, antimigraine preparations, ATC code: N02CX07
Croatian: Farmakoterapijska skupina: Analgetici, pripravci za liječenje migrene, ATK oznaka: N02CX07 Mehanizam djelovanja
English: A total of over 2,500 patients (more than 2,600 patient years) have been treated with Aimovig in registration studies.
Croatian: Ukupno je više od 2500 bolesnika (više od 2600 bolesnik-godina) liječeno Aimovigom u ispitivanjima za registraciju.
English: Using slow and constant pressure, push the plunger rod all the way down until it stops moving.
Croatian: Uz polagan i konstantan pritisak pritisnite klip do kraja dok se ne prestane micati.
English: Both <0.001a,d
Croatian: n/a oboje <0,001 a,d
English: 74.1% of patients completed the 52-week extension.
Croatian: 74,1% bolesnika završilo je 52-tjedni nastavak ispitivanja.
English: Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period.
Croatian: Poznato je da se ljudski imunoglobulini G (IgG) izlučuju u mlijeko tijekom prvih nekoliko dana nakon poroda, što se ubrzo zatim smanjuje na niske koncentracije; posljedično, ne može se isključiti rizik za dojenče na majčinom mlijeku tijekom ovog kratkog razdoblja.
English: For secondary endpoints, all p-values are reported as unadjusted p-values and are statistically significant after adjustment for multiple comparisons.
Croatian: Za sekundarne mjere ishoda, sve p-vrijednosti prijavljene su kao neprilagođene p-vrijednosti i statistički su značajne nakon prilagodbe za višestruke usporedbe.
English: Pruritus includes preferred terms of generalised pruritus, pruritus and pruritic rash.
Croatian: Pruritus uključuje preporučene pojmove generalizirai pruritus, pruritus i pruritični osip.
English: Note: When you remove the syringe, if it looks like there is still medicine in the syringe barrel this means you have not received a full dose.
Croatian: Napomena: kad uklonite štrcaljku, ako izgleda kao da ima još lijeka u tijelu štrcaljke, to znači da niste primili cijelu dozu.
English: Remove your thumb from the button, but keep pushing down on the skin.
Croatian: Maknite palac s tipke, ali i dalje držite brizgalicu pritisnutu na kožu.
English: Before you use the Aimovig pre-filled syringe, read this important information:
Croatian: Prije nego što upotrijebite Aimovig napunjenu štrcaljku, pročitajte ove važne informacije:
English: Carcinogenicity studies have not been conducted with erenumab.
Croatian: Ispitivanja kancerogenosti nisu provedena s erenumabom.
English: Do not use this medicine if you notice that the solution contains particles, is cloudy or is distinctly yellow.
Croatian: Ne upotrebljavajte ovaj lijek ako primijetite da otopina sadrži čestice, da je zamućena ili izrazito žuta.
English: You may need to use either one or two syringes based on your prescribed dose.
Croatian: Možda ćete morati koristiti jednu ili dvije štrcaljke na temelju propisane doze.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for erenumab, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za erenumab, znanstveni zaključci CHMP-a su sljedeći:
English: When done, release your thumb, and gently lift the syringe off of the skin and then release the pinched skin.
Croatian: Kad završite, maknite palac i lagano podignite štrcaljku od kože te otpustite uštipnutu kožu.
English: The removable cap of the Aimovig pre-filled syringe/pen contains dry natural rubber latex, which may cause allergic reactions in individuals sensitive to latex.
Croatian: Zaštitna kapica Aimovig napunjene štrcaljke/brizgalice sadrži lateks od suhe prirodne gume, koji može uzrokovati alergijske reakcije u pojedinaca osjetljivih na lateks.
English: Patients had a median age of 43 years, 83% were female and 94% were white.
Croatian: Bolesnici su imali medijan dobi od 43 godine, 83% bile su žene i 94% bijelci.
English: Following a single 140 mg intravenous dose, the mean (SD) volume of distribution during the terminal phase (Vz) was estimated to be 3.86 (0.77) l.
Croatian: Nakon jednokratne intravenske doze od 140 mg, srednji (SD) volumen distribucije tijekom terminalne faze (Vz) procjenjivao se na 3,86 (0,77) l.
English: The most frequent injection site reactions were localised pain, erythema and pruritus.
Croatian: Najučestalije reakcije na mjestu primjene injekcije bile su lokalizirana bol, eritem i pruritus.
English: Erenumab potently and specifically competes with the binding of CGRP and inhibits its function at the CGRP receptor, and has no significant activity against other calcitonin family of receptors.
Croatian: Erenumab se potentno i specifično natječe s vezanjem CGRP-a i inhibira njegovu funkciju na CGRP receptoru te nema značajnu aktivnost prema drugim članovima kalcitoninske obitelji receptora.
English: CI = confidence interval; MMD = monthly migraine days; HIT-6 = Headache Impact Test; MIDAS = Migraine Disability Assessment a
Croatian: CI = interval pouzdanosti; DMM = dani migrene mjesečno; HIT-6 = Test utjecaja glavobolje; MIDAS = Procjena onesposobljenosti uzrokovane migrenom a
English: There was no impact of anti-erenumab antibody development on efficacy or safety.
Croatian: Razvoj protutijela na erenumab nije utjecao na djelotvornost ili sigurnost.
English: Patients with renal impairment Patients with severe renal impairment (eGFR <30 ml/min/1.73 m2) have not been studied.
Croatian: Bolesnici s oštećenjem bubrega Bolesnici s teškim oštećenjem bubrega (eGFR <30 ml/min/1,73 m2) nisu bili ispitivani.
English: Aimovig is intended for patient self-administration after proper training.
Croatian: Aimovig je namijenjen za bolesnikovu samoprimjenu nakon odgovarajuće obuke.
English: Firmly push the pen down onto the skin until it stops moving.
Croatian: Čvrsto pritisnite brizgalicu na kožu dok se ne prestane micati.
English: Overall, 68% had failed one or more previous prophylactic pharmacotherapies due to lack of efficacy or poor tolerability, and 49% had failed two or more previous prophylactic pharmacotherapies due to lack of efficacy or poor tolerability.
Croatian: Ukupno je u 68% slučajeva jedna ili više prethodnih profilaktičkih farmakoterapija bila neuspješna zbog nedostatka djelotvornosti ili slabe podnošljivosti, a u 49% slučajeva je dvije ili više prethodnih profilaktičkih farmakoterapija bilo neuspješno zbog nedostatka djelotvornosti ili slabe podnošljivosti.
English: The CGRP receptor is located at sites that are relevant to migraine pathophysiology, such as the trigeminal ganglion.
Croatian: CGRP receptor smješten je na mjestima koja su relevantna za patofiziologiju migrene, kao što je trigeminalni ganglij.
English: Do not choose an area where the skin is tender, bruised, red, or hard.
Croatian: - Nemojte odabrati područje na kojem je koža osjetljiva, s modricama, crvena ili tvrda.
English: What Aimovig is and what it is used for What you need to know before you use Aimovig How to use Aimovig
Croatian: Što je Aimovig i za što se koristi Što morate znati prije nego počnete primjenjivati Aimovig Kako primjenjivati Aimovig
English: Gather all materials needed for the injection(s).
Croatian: Prikupite sve materijale potrebne za injekciju(e).
English: When you remove the pen, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means you have not received a full dose.
Croatian: Kad maknete brizgalicu, ako prozorčić nije požutio ili ako izgleda kao da se lijek još uvijek ubrizgava, to znači da niste primili cijelu dozu.