FrancophonIA/ELRC3.0 huggingface dataset:
English: Although a possible effect on tiredness and weakness was observed, shortcomings in the design of the studies prevented any firm conclusions being drawn.
Croatian: Iako je zamijećen mogući učinak na umor i slabost, zbog nedostataka nacrta ispitivanja nije bilo moguće doći do pouzdanih zaključaka.
English: Eleutherococcus root should only be used in adults and adolescents over the age of 12 years and should not be taken for more than 2 months.
Croatian: Korijen sibirskog ginsenga smije se koristiti samo u odraslih osoba i adolescenata starijih od 12 godina i ne smije se koristiti dulje od dva mjeseca.
English: 2 February 2016 EMA/283374/2014
Croatian: EMA/283374/2014
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom consulted if the symptoms continue for more than 2 weeks of treatment.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom2. veljače 2016.
English: What are the HMPC conclusions on its medicinal uses?
Croatian: Koji su zaključci HMPC-a o njegovoj medicinskoj primjeni?
English: Eleutherococcus senticosus (Rupr.
Croatian: Eleutherococcus senticosus (Rupr. et Maxim.)
English: Eleutherococcus root EMA/283374/2014
Croatian: Korijen sibirskog ginsenga EMA/283374/2014
English: For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.
Croatian: Za detaljnije informacije o ispitivanjima koje je ocijenio HMPC pogledajte izvješće HMPC-a o ocjeni lijeka.
English: In some cases the solvent is evaporated to obtain a dry extract.
Croatian: U nekim se slučajevima otapalo uparava kako bi se dobio suhi ekstrakt.
English: They are also obtained by using a technique to extract compounds from plant material by dissolving them in a solvent (such as ethanol or water) to form a liquid extract or tincture (an alcoholic extract).
Croatian: Također se dobivaju primjenom tehnike za ekstrakciju spojeva otapanjem biljnog materijala u otapalu (npr. etanol ili voda) kako bi se dobio tekući ekstrakt ili tinktura (alkoholni ekstrakt).
English: The HMPC concluded that, on the basis of its long-standing use, eleutherococcus root can be used for the relief of symptoms of asthenia (abnormal loss of strength and energy) such as tiredness and weakness.
Croatian: Na temelju dugotrajne primjene, HMPC je zaključio da se korijen sibirskog ginsenga može koristiti za ublažavanje simptoma astenije (abnormalan gubitak snage i energije) poput umora i slabosti.
English: Further information on the HMPC assessment of eleutherococcus root medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Daljnje informacije o HMPC-ovoj ocjeni lijekova koji sadrže korijen sibirskog ginsenga, uključujući pojedinosti zaključaka Odbora, mogu se pronaći pod karticom „All documents” na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Any applications for the licensing of medicines containing eleutherococcus root have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Croatian: Svi zahtjevi za odobrenje lijekova koji sadrže korijen sibirskog ginsenga moraju se podnijeti nacionalnim tijelima nadležnima za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: Insomnia, irritability, tachycardia (rapid heartbeat) and headaches have been reported as side effects with eleutherococcus root medicines, although their frequency is not known.
Croatian: Nesanica, razdražljivost, tahikardija (ubrzani otkucaji srca) i glavobolje prijavljene su nuspojave prilikom primjene lijekova koji sadrže korijen sibirskog ginsenga, no njihova učestalost nije poznata.
English: Further information on the risks associated with eleutherococcus root medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Više o rizicima povezanim s lijekovima koji sadrže korijen sibirskog ginsenga, uključujući odgovarajuće mjere opreza za njihovu sigurnu primjenu, možete pronaći u monografiji pod karticom „All documents” na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Herbal medicines containing eleutherococcus root are usually available as herbal teas to be drunk, or in solid or liquid forms to be taken by mouth.
Croatian: Biljni lijekovi koji sadrže korijen sibirskog ginsenga najčešće su dostupni kao biljni čajevi koji se piju ili u krutom ili tekućem obliku za uzimanje kroz usta.
English: Eleutherococcus root is the common name for the root of the plant Eleutherococcus senticosus (Rupr.
Croatian: Korijen sibirskog ginsenga uobičajeni je naziv za korijen biljke Eleutherococcus senticosus (Rupr. et Maxim.)
English: Eleutherococcus root can also be found in combination with other herbal substances in some herbal medicines.
Croatian: Korijen sibirskog ginsenga može postojati također i u kombinaciji s drugim biljnim tvarima u nekim biljnim lijekovima.
English: This summary is not intended to provide practical advice on how to use medicines containing eleutherococcus root.
Croatian: Svrha ovog sažetka nije davati praktične savjete o načinu primjene lijekova koji sadrže korijen sibirskog ginsenga.
English: The HMPC conclusions on the use of eleutherococcus root medicines for relieving symptoms of asthenia are based on their ‘traditional use' in this condition.
Croatian: Zaključci HMPC-a o primjeni lijekova koji sadrže korijen sibirskog ginsenga za ublažavanje simptoma astenije temelje se na njihovoj „tradicionalnoj primjeni” kod tog stanja.
English: Eleutherococcus root preparations are obtained by drying and comminuting (reducing into tiny pieces) or powdering the root.
Croatian: Pripravci od korijena sibirskog ginsenga dobivaju se sušenjem i usitnjavanjem (smanjivanjem na manje komadiće) ili usitnjavanjem korijena u prah.
English: Information on the use and licensing of eleutherococcus root medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o primjeni i davanju odobrenja za lijekove koji sadrže korijen sibirskog ginsenga u državama članicama EU-a mogu se dobiti od nadležnih nacionalnih tijela.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing eleutherococcus root.
Croatian: Države članice EU-a uzimaju u obzir zaključke HMPC-a prilikom ocjene zahtjeva za davanje odobrenja za biljne lijekove koji sadrže korijen sibirskog ginsenga.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of eleutherococcus root.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Odbora za biljne lijekove (HMPC) u pogledu medicinske primjene korijena sibirskog ginsenga.
English: In its assessment, the HMPC also considered numerous clinical studies with eleutherococcus root.
Croatian: Prilikom svoje ocjene HMPC je razmotrio i niz kliničkih ispitivanja korijena sibirskog ginsenga.
English: For more information about treatment with eleutherococcus root medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Za više informacija o liječenju lijekovima koji sadrže korijen sibirskog ginsenga pročitajte uputu o lijeku priloženu uz lijek, odnosno obratite se svom liječniku ili ljekarniku.
English: Detailed instructions on how to take eleutherococcus root medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: o načinu uzimanja lijekova koji sadrže korijen sibirskog ginsenga i o tome tko ih smije uzimati navedene su u uputi o lijeku koja je priložena uz lijek.
English: For practical information about using eleutherococcus root medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Croatian: Za praktične informacije o primjeni lijekova koji sadrže korijen sibirskog ginsenga bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svom liječniku ili ljekarniku.
English: A doctor or a qualified healthcare practitioner should be
Croatian: Potrebno je obratiti se liječniku ili kvalificiranom zdravstvenom djelatniku ako se simptomi nastave dulje od dva tjedna tijekom liječenja.
English: Therefore, the HMPC conclusions on the use of eleutherococcus root medicines are based on their long-standing use.
Croatian: Zaključci HMPC-a o lijekovima koji sadrže korijen sibirskog ginsenga stoga se temelje na njihovoj dugotrajnoj primjeni.
English: What are the risks associated with eleutherococcus root medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže korijen sibirskog ginsenga?
English: Other information about eleutherococcus root medicines
Croatian: Ostale informacije o lijekovima koji sadrže korijen sibirskog ginsenga
English: What evidence supports the use of eleutherococcus root medicines?
Croatian: Kojim se dokazima potkrjepljuje primjena lijekova koji sadrže korijen sibirskog ginsenga?
English: How are eleutherococcus root medicines approved in the EU?
Croatian: Kako se u EU-u odobravaju lijekovi koji sadrže korijen sibirskog ginsenga?
English: What is eleutherococcus root?
Croatian: Što je korijen sibirskog ginsenga?
English: You may need to read it again.
Croatian: Možda ćete je trebati ponovno pročitati.
English: • At the request of the European Medicines Agency;
Croatian: • na zahtjev Europske agencije za lijekove;
English: If your symptoms do not improve
Croatian: Ako Vam se simptomi ne poboljšaju
English: Date of first authorisation: 20th March 2017
Croatian: Datum prvog odobrenja: 20. ožujka 2017.
English: This will allow quick identification of new safety information.
Croatian: Time se omogućuje brzo otkrivanje novih sigurnosnih informacija.
English: 55 micrograms
Croatian: 55 mikrograma
English: - This medicine has been prescribed for you only.
Croatian: - Ovaj je lijek propisan samo Vama.
English: Children and adolescents Do not give this medicine to children or adolescents below the age of 18 years.
Croatian: Nemojte davati ovaj lijek djeci i adolescenatima mlađima od 18 godina.
English: Health-related quality of life:
Croatian: Kvaliteta života vezana uz zdravlje:
English: This leaflet was last revised in Other sources of information
Croatian: Ova uputa je zadnji puta revidirana u Ostali izvori informacija
English: What is in this leaflet
Croatian: Što se nalazi u ovoj uputi
English: • infection of nose and throat
Croatian: • infekcija nosa i grla
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV
English: Just inhale your next dose at the usual time.
Croatian: Samo inhalirajte sljedeću dozu u uobičajeno vrijeme.
English: Check with your doctor or pharmacist if you are not sure.
Croatian: Provjerite s liječnikom ili ljekarnikom ako niste sigurni.
English: UNIQUE IDENTIFIER - 2D BARCODE
Croatian: JEDINSTVENI IDENTIFIKATOR - 2D BARKOD
English: An updated RMP should be submitted:
Croatian: Ažurirani RMP treba dostaviti:
English: If possible, show them the inhaler, the package or this leaflet.
Croatian: Ako je moguće, pokažite im inhalator, pakiranje ili ovu uputu.
English: Once daily
Croatian: Jedanput na dan.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Croatian: DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO
English: Component of a multipack can't be sold separately.
Croatian: Sastavni dio višestrukog pakiranja, ne može se prodavati odvojeno.
English: This will help to keep you free of symptoms throughout the day and night.
Croatian: Na taj ćete se način lakše osloboditi simptoma i danju i noću.
English: Other side effects have occurred in a very small number of people but their exact frequency is unknown (cannot be estimated from the available data):
Croatian: Druge nuspojave javile su se kod vrlo malog broja ljudi, ali je njihova točna učestalost nepoznata (ne može se procijeniti iz dostupnih podataka):
English: • Breathe out slowly and gently.
Croatian: • Polako i nježno izdahnite.
English: Systemic exposure to the metabolites is low.
Croatian: Sistemska izloženost metabolitima je niska.
English: Ask your pharmacist how to dispose of medicines no longer required.
Croatian: Pitajte svoga ljekarnika kako baciti lijekove koje više ne koristite.
English: Hold this breath in for as long as possible (at least 3-4 seconds).
Croatian: Zadržite taj dah koliko god dugo možete (najmanje 3-4 sekunde).
English: Biotransformation
Croatian: Biotransformacija
English: Do not store above 30°C.
Croatian: Ne čuvati na temperaturi iznad 30°C.
English: Check with your doctor if you think any of these may apply to you.
Croatian: Provjerite sa svojim liječnikom ako mislite da bi se nešto od navedenoga moglo odnositi na Vas.
English: You may notice that your heart is beating faster than usual, you have visual disturbances or have a dry mouth.
Croatian: Možda ćete primijetiti da Vam srce kuca brže nego inače, da imate smetnje vida ili suha usta.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek jer sadrži Vama važne podatke.
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 uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Allergic reactions are uncommon (may affect up to 1 in 100 people).
Croatian: Alergijske reakcije su manje česte (mogu se javiti u do 1 na 100 osoba).
English: Do not throw away any medicines via wastewater or household waste.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: • Risk Management Plan (RMP)
Croatian: LIJEKA • Plan upravljanja rizikom (RMP)
English: It is not possible to accidentally take extra medicine or a double dose in one inhalation.
Croatian: Nije moguće slučajno uzeti veću količinu lijeka ili dvostruku dozu u jednoj inhalaciji.
English: Take it back to your pharmacist for advice.
Croatian: Vratite ga ljekarniku i zatražite savjet.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
English: A risk to breastfed newborns/infants cannot be excluded.
Croatian: Ne može se isključiti rizik za dojenu novorođenčad/dojenčad.
English: Therefore, statistical significance on this comparison cannot be inferred.
Croatian: Stoga se statistička značajnost spomenute usporedbe ne može utvrditi.
English: Allergic reactions
Croatian: Alergijske reakcije
English: This includes 576 patients who received the recommended dose of 55 micrograms once daily.
Croatian: To uključuje 576 bolesnika koji su primali preporučenu dozu od 55 mikrograma jedanput na dan.
English: Instructions for use:
Croatian: Upute za primjenu:
English: Reproductive toxicity
Croatian: Reproduktivna toksičnost
English: Glaxo Wellcome Production Zone Industrielle No.2, 23 Rue Lavoisier, 27000 Evreux, France
Croatian: Glaxo Wellcome Production Zone Industrielle No.2, 23 Rue Lavoisier, 27000 Evreux, Francuska
English: This will help to protect the environment.
Croatian: Ove će mjere pomoći u očuvanju okoliša.
English: Always use this medicine exactly as your doctor has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako Vam je rekao liječnik.
English: After this date the inhaler should no longer be used.
Croatian: Nakon tog datuma inhalator se više ne smije upotrijebiti.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama nisu ukazala na izravne niti neizravne štetne učinke kada je u pitanju reproduktivna toksičnost (vidjeti dio 5.3).
English: Umeclidinium bromide should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the fetus.
Croatian: Umeklidinijev bromid se tijekom trudnoće smije primjenjivati samo ako očekivana korist za majku opravdava mogući rizik za plod.
English: In vitro plasma protein binding in human plasma was on average 89%.
Croatian: Vezanje za proteine u plazmi ljudi in vitro u prosjeku je iznosilo 89%.
English: No formal statistical testing was performed on this endpoint.
Croatian: Nije provedeno formalno statističko ispitivanje za ovu mjeru ishoda.
English: The recommended dose is one inhalation every day at the same time of day.
Croatian: Preporučena doza je jedna inhalacija svakoga dana u isto vrijeme.
English: Summary of the safety profile
Croatian: Sažetak sigurnosnog profila
English: The MAH shall complete, within the stated timeframe, the below measure:
Croatian: Nositelj odobrenja dužan je, unutar navedenog vremenskog roka, provesti niže navedene mjere:
English: This medicinal product contains lactose.
Croatian: Ovaj lijek sadrži laktozu.
English: In addition, patients with clinically significant uncontrolled cardiovascular disease were excluded from clinical studies.
Croatian: Osim toga, bolesnici s klinički značajnom nekontroliranom kardiovaskularnom bolešću nisu bili uključeni u klinička ispitivanja.
English: See section 4.
Croatian: Pogledajte dio 4.
English: The tray can be discarded after first opening.
Croatian: Podložak se može baciti nakon prvog otvaranja.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primijenite ovaj lijek.
English: Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control.
Croatian: Pojačano korištenje kratkodjelujućih bronhodilatatora za ublažavanje simptoma ukazuje na slabiju kontrolu bolesti.
English: If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Croatian: Ako dođe do predoziranja, bolesnika treba liječiti suportivno te po potrebi uvesti odgovarajući nadzor.
English: Characteristics in specific groups of subjects or patients
Croatian: Značajke u posebnim skupinama ispitanika ili bolesnika
English: Warnings and precautions
Croatian: Upozorenja i mjere opreza
English: Non clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenog potencijala.
English: The dose counter counts down by 1 to confirm.
Croatian: Broj na brojaču doza smanjit će se za 1 u znak potvrde.
English: You may not be able to taste or feel the medicine, even when you are using the inhaler correctly.
Croatian: Možda nećete moći okusiti ni osjetiti lijek, čak ni kada inhalator koristite na pravilan način.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Moguće nuspojave Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: You only need to inhale once a day because the effect of this medicine lasts for 24 hours.
Croatian: Dovoljno je da lijek inhalirate jedanput na dan jer on djeluje tijekom 24 sata.
English: - if you are allergic to umeclidinium or any of the other ingredients of this medicine (listed in section
Croatian: - ako ste alergični na umeklidinij ili neki drugi sastojak ovoga lijeka (naveden u dijelu 6.).
English: When you take the inhaler out of its tray, it will be in the ‘closed' position.
Croatian: Kad izvadite inhalator iz njegovog podloška, bit će u „zatvorenom“ položaju.
English: Distribution
Croatian: Distribucija
English: It will only be effective as long as you are using it. Don't stop unless your doctor advises you to, even if you feel better, as your symptoms may get worse.
Croatian: Nemojte prestati primjenjivati lijek, osim ako Vam to ne kaže liječnik, čak i ako se osjećate bolje, jer se simptomi mogu pogoršati.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: a) Prepare a dose
Croatian: a) Pripremite dozu
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Following intravenous administration to healthy subjects, the mean volume of distribution was 86 litres.
Croatian: Nakon intravenske primjene u zdravih ispitanika, srednja vrijednost volumena distribucije iznosila je 86 litara.
English: 4.6 Fertility, pregnancy and lactation
Croatian: 4.6 Plodnost, trudnoća i dojenje Trudnoća
English: A. Menarini Industrie Farmaceutiche Riunite s.r.l.
Croatian: Menarini Industrie Farmaceutiche Riunite s.r.l.
English: If you have any of the following symptoms after taking Rolufta Ellipta, stop using this medicine and tell your doctor immediately:
Croatian: Ako imate bilo koji od sljedećih simptoma nakon primjene lijeka Rolufta Ellipta, prekinite primjenu ovog lijeka i odmah obavijestite svog liječnika:
English: Asthma
Croatian: Astma
English: Plasma clearance following intravenous administration was 151 litres/hour.
Croatian: Eliminacija Klirens iz plazme nakon intravenske primjene iznosio je 151 litara/sat.
English: It is very important that you use Rolufta Ellipta every day, as instructed by your doctor.
Croatian: Vrlo je važno da lijek Rolufta Ellipta primjenjujete svaki dan prema uputama liječnika.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: 4.7 Effects on ability to drive and use machines
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima
English: 2) Prepare a dose
Croatian: 2) Pripremite dozu
English: Keep this medicine out of the sight and reach of children.
Croatian: Lijek čuvajte izvan pogleda i dohvata djece.
English: If you accidentally use too much of this medicine, contact your doctor or pharmacist for advice immediately as you may need medical attention.
Croatian: Ako slučajno primijenite previše ovog lijeka, odmah se obratite svom liječniku ili ljekarniku za savjet jer ćete možda trebati liječničku pomoć.
English: Elderly patients
Croatian: Stariji bolesnici
English: If your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse, or if you are using your quick-acting inhaler more often: contact your doctor as soon as possible.
Croatian: Ako Vam se simptomi KOPB-a (nedostatak zraka, piskanje pri disanju, kašalj) ne poboljšaju ili se pogoršaju, ili ako primjenjujete brzodjelujući inhalacijski lijek češće nego inače: obratite se svom liječniku što je prije moguće.