FrancophonIA/ELRC3.0 huggingface dataset:
English: Jinarc can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in treating autosomal dominant polycystic kidney disease and with knowledge about the risks of treatment with Jinarc.
Croatian: Jinarc se izdaje samo na liječnički recept, a terapiju treba započeti i pratiti liječnik iskusan u liječenju autosomatske dominantne bolesti policističnih bubrega te koji je upoznat s rizicima liječenja lijekom Jinarc.
English: Results showed that in patients treated with Jinarc the decline in kidney function was 35% less than with placebo after 1 year of treatment.
Croatian: Rezultati su pokazali da je u bolesnika koji su primali terapiju lijekom Jinarc nakon jedne godine liječenja smanjenje funkcije bubrega bilo 35 % manje nego kod bolesnika koji su uzimali placebo.
English: What benefits of Jinarc have been shown in studies?
Croatian: Koje su koristi od lijeka Jinarc utvrđene u ispitivanjima?
English: How does Jinarc work?
Croatian: Kako djeluje Jinarc?
English: Jinarc must not be used in patients who are anuric (cannot pass urine or have difficulty in passing it), volume depleted (have reduced amounts of fluids in the body) and in patients who cannot perceive or respond to thirst.
Croatian: Jinarc se ne smije koristiti u bolesnika s anurijom (nemogućnošću mokrenja ili otežanim mokrenjem), kod kojih postoji deplecija volumena (smanjene količine tekućina u tijelu) i u bolesnika koji ne osjećaju žeđ ili ne odgovaraju na žeđ. Ne smije se koristiti u bolesnika s hipernatremijom (povišenim koncentracijama natrija u krvi) i u bolesnika koji su alergični na tolvaptan ili lijekove slične tolvaptanu, takozvane benzazepine ili njihove derivate.
English: For the full list of side effects reported with Jinarc, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Jinarc potražite u uputi o lijeku.
English: 4 December 2015
Croatian: 4. prosinec 2015.
English: EMA/HMPC/333915/2015 Corr.1
Croatian: EMA/HMPC/333915/2015
English: These medicines should only be used in adults and should not be taken for longer than 10 days.
Croatian: Lijekovi se trebaju koristiti samo u odraslih osoba tijekom razdoblja ne duljeg od 10 dana.
English: However, the amount of pyrrolizidine alkaloids has to be specified in each comfrey root medicine and patients should not be exposed to more than 0.35 microgram of pyrrolizidine alkaloids per day.
Croatian: Međutim, količina pirolizidinskih alkaloida mora biti specificirana u svakom lijeku koji sadrži gavezov korijen, a bolesnik se ne smije izlagati količini većoj od 0,35 mikrograma pirolizidinskih alkaloida dnevno.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Croatian: dovoljno dokaza iz kliničkih ispitivanja, učinkovitost tih biljnih lijekova je vjerojatna te postoji dokaz sigurne uporabe na opisani način tijekom najmanje 30 godina (uključujući najmanje 15 godina u EUu).
English: Comfrey root EMA/HMPC/333915/2015
Croatian: Gavezov korijen EMA/HMPC/333915/2015
English: The HMPC also noted 4 clinical studies carried out with a different comfrey preparation (not covered by this summary).
Croatian: HMPC je također istaknuo 4 klinička ispitivanja provedena s različitim pripravcima gavezovog korijena (nisu obuhvaćena ovim sažetkom).
English: No significant risk is expected when comfrey root medicines are used on the skin for short periods.
Croatian: Ne očekuje se značajan rizik ako se lijekovi koji sadrže gavezov korijen koriste na koži tijekom kratkih razdoblja.
English: At the time of the HMPC assessment, no side effects had been reported with these medicines.
Croatian: U trenutku ocjene HMPC-a, nisu prijavljene nikakve nuspojave prilikom primjene ovih lijekova.
English: Information on the use and licensing of comfrey root medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o uporabi i odobrenju lijekova koji sadrže gavezov korijen u državama članicama EU-a treba zatražiti od nadležnih nacionalnih tijela.
English: Comfrey root contains substances known as pyrrolizidine alkaloids, which have toxic effects on the liver when taken by mouth.
Croatian: Gavezov korijen sadrži tvari poznate pod nazivom pirolizidinski alkaloidi koji imaju toksično djelovanje na jetru kada se uzimaju kroz usta.
English: However, since the exact composition of the herbal preparation used in these studies is not known, these data were not taken into account and the HMPC conclusions on the use of comfrey root medicines are based on their long-standing use.
Croatian: Međutim, budući da točan sastav biljnog pripravka koji se koristio u tim ispitivanjima nije poznat, podaci nisu uzeti u obzir te su zaključci HMPC-a o primjeni lijekova koji sadrže gavezov korijen temeljeni na njegovoj dugotrajnoj primjeni.
English: Any applications for the licensing of medicines containing comfrey 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 gavezov korijen moraju se podnijeti nacionalnim tijelima nadležnim za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: Further information on the risks associated with comfrey 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 informacija o rizicima povezanim s lijekovima koji sadrže gavezov korijen, uključujući odgovarajuće mjere opreza za sigurnu uporabu, nalazi se u monografiji u rubrici „All documents” na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the HMPC assessment of comfrey 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: Dodatne informacije o HMPC-ovoj ocjeni lijekova koji sadrže gavezov korijen, uključujući pojedinosti zaključaka Povjerenstva, nalaze se u rubrici „All documents” na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC conclusions on the use of comfrey root medicines for the relief of symptoms of minor sprains and bruises are based on their ‘traditional use' in these conditions.
Croatian: Zaključci HMPC-a o uporabi lijekova koji sadrže gavezov korijen za ublažavanje simptoma blažih istegnuća i modrica temelje se na „tradicionalnoj uporabi” kod tih stanja.
English: Herbal medicines containing this comfrey root preparation are available in semi-solid forms (such as creams or ointments) to be applied to the skin.
Croatian: Biljni lijekovi koji sadrže ovaj pripravak gavezovog korijena dostupni su u polučvrstom obliku (poput krema ili masti) za primjenu na kožu.
English: What is comfrey root?
Croatian: Što je gavezov korijen?
English: This summary is not intended to provide practical advice on how to use medicines containing comfrey root.
Croatian: Svrha ovog sažetka nije pružanje praktičnih savjeta za uporabu lijekova koji sadrže gavezov korijen.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of comfrey root.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Povjerenstva za biljne lijekove (HMPC) u pogledu medicinske uporabe gavezovog korijena.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing comfrey root.
Croatian: Države članice EU-a uzimaju u obzir zaključke HMPCa prilikom ocjenjivanja zahtjeva za odobrenje biljnih lijekova koji sadrže gavezov korijen.
English: These studies suggested a reduction in swelling and pain in patients using this herbal preparation for sprains and bruises.
Croatian: Ta ispitivanja ukazuju na smanjenje otoka i boli u bolesnika koji su uzimali ovaj biljni pripravak za istegnuća i modrice.
English: Detailed instructions on how to take comfrey root medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: Detaljne upute o načinu primjene lijekova koji sadrže gavezov korijen te o tome tko ih može koristiti navedene su u uputi o lijeku priloženoj uz lijek.
English: In its assessment, the HMPC considered the well documented use of comfrey root for the relief of symptoms of minor sprains and bruises.
Croatian: U svojoj ocjeni, HMPC je razmotrio dobro dokumentiranu uporabu gavezovog korijena za ublažavanje simptoma blažih istegnuća i modrica.
English: Comfrey root is the common name for the root of the plant Symphytum officinale L. This summary covers Comfrey root medicines containing a specific herbal preparation, which is obtained by ethanol extraction (a technique used to extract compounds from plant material by dissolving them in alcohol).
Croatian: Ovaj sažetak odnosi se na lijekove koji sadrže specifičan biljni pripravak gavezovog korijena koji se dobiva ekstrakcijom etanolom (tehnika koja se koristi za ekstrakciju spojeva iz dijelova biljaka otapanjem u alkoholu).
English: Other information about comfrey root medicines
Croatian: Ostale informacije o lijekovima koji sadrže gavezov korijen
English: What are the risks associated with comfrey root medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže gavezov korijen?
English: The HMPC concluded that, on the basis of its long-standing use, these comfrey root medicines can be used for the relief of symptoms of minor sprains and bruises.
Croatian: HMPC je zaključio da se, na temelju dugotrajne primjene, lijekovi koji sadrže gavezov korijen mogu koristiti za ublažavanje simptoma blažih istegnuća i modrica.
English: For more information about treatment with comfrey root medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekovima koji sadrže gavezov korijen pročitajte u uputi o lijeku priloženoj uz lijek, odnosno obratite se svom liječniku ili ljekarniku.
English: For practical information about using comfrey root 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 gavezov korijen bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svojem liječniku ili ljekarniku.
English: What evidence supports the use of comfrey root medicines?
Croatian: Koji dokazi potkrjepljuju uporabu lijekova koji sadrže gavezov korijen?
English: How are comfrey root medicines approved in the EU?
Croatian: Kako se u EU-u odobravaju lijekovi koji sadrže gavezov korijen?
English: Comfrey root
Croatian: Gavezov korijen
English: Do not take a double dose to make up for a forgotten tablet
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu tabletu.
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek uzimajte ovaj lijek točno onako kako Vam je rekao Vaš liječnik ili ljekarnik.
English: • if you have had an allergy or reaction to any medicine used to treat your disease.
Croatian: • ako ste imali alergiju ili reakciju na bilo koji lijek koji ste koristili za liječenje Vaše bolesti.
English: Put the tablet in your mouth and swallow with water or another liquid.
Croatian: Staviti tabletu u usta i progutati s vodom ili nekom drugom tekućinom.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI JEDINICI LIJEKA
English: The patient population included 41.8% women.
Croatian: Populacija bolesnika uključivala je 41,8% žena.
English: Balkanpharma Dupnitsa AD 3 Samokovsko Shosse Str., Dupnitsa 2600, Bulgaria
Croatian: Balkanpharma Dupnitsa AD 3 Samokovsko Shosse Str., Dupnitsa 2600, Bugarska
English: Date of first authorisation: 28 July 2009 Date of latest renewal: 16 May 2014
Croatian: Datum zadnje obnove odobrenja: 16. svibnja 2014.
English: • If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section
Croatian: • ako ste alergični na klopidogrel ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: However, clopidogrel and ASA have been administered together for up to one year (see section
Croatian: Međutim, klopidogrel i ASK su se istodobno primjenjivali u trajanju do jedne godine (vidjeti dio
English: The ACTIVE-A study included patients who could not receive VKA therapy because they were unable or unwilling to receive the treatment.
Croatian: Studija ACTIVE-A uključivala je bolesnike koji nisu mogli primati terapiju VKA, zbog toga što nisu bili podobni ili nisu željeli primati terapiju.
English: Some other medicines may influence the use of Clopidogrel Teva or vice versa.
Croatian: Neki lijekovi mogu utjecati na djelovanje Klopidogrela Teva i obratno.
English: • if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days
Croatian: • ako ste imali krvni ugrušak u arteriji u mozgu (ishemijski moždani udar) koji se pojavio unutar posljednjih sedam dana.
English: It is preferable not to take this medicine during pregnancy.
Croatian: Ne preporučuje se uzimanje ovoga lijeka za vrijeme trudnoće.
English: Carefully peel off the backing.
Croatian: Pažljivo odlijepiti stražnju stranu folije.
English: How to store Clopidogrel Teva Contents of the pack and other information
Croatian: Kako čuvati Klopidogrel Teva Sadržaj pakiranja i druge informacije
English: Patients who had developed a previous allergic reaction and/or haematological reaction to one thienopyridine may have an increased risk of developing the same or another reaction to another thienopyridine.
Croatian: Bolesnici koji su prethodno razvili alergijsku reakciju i/ili hematološku reakciju na jedan od tienopiridina mogu imati povišeni rizik od razvoja iste ili druge reakcijena drugi tienopiridin.
English: Clopidogrel Teva contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Croatian: Klopidogrel Teva sadrži klopidogrel i pripada skupini lijekova koji se nazivaju antitrombocitni lijekovi.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Croatian: Detaljne informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu/
English: Bottles contain 30 or 100 film-coated tablets.
Croatian: Bočice sadržavaju 30 ili 100 filmom obloženih tableta.
English: Clopidogrel has been evaluated for safety in more than 44,000 patients who have participated in clinical studies, including over 12,000 patients treated for 1 year or more.
Croatian: Sigurnost primjene klopidogrela ispitana je na više od 44 000 bolesnika koji su sudjelovali u kliničkim ispitivanjima, uključujući više od 12 000 bolesnika koji su lijek primali godinu dana ili više.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajima nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
English: Do not use this medicine after the expiry date which is stated on the outer carton, bottle or blister, after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, bočici ili blisteru iza oznake „EXP“.
English: Clopidogrel Teva 75 mg
Croatian: Klopidogrel Teva 75 mg
English: Your doctor should have prescribed Clopidogrel Teva and acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding.
Croatian: Liječnik Vam treba propisati Klopidogrel Teva i acetilsalicilatnu kiselinu ako ne možete uzimati oralne antikoagulanse te nemate rizik od velikog krvarenja.
English: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Croatian: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, Velika Britanija
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Croatian: detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu
English: While you are taking Clopidogrel Teva:
Croatian: Dok uzimate Klopidogrel Teva:
English: After single and repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed.
Croatian: Nakon jednokratne i ponovljene oralne doze od 75 mg na dan, klopidogrel se brzo apsorbira.
English: What Clopidogrel Teva is and what it is used for
Croatian: Što je Klopidogrel teva i za što ste koristi
English: Light pink to pink, capsule-shaped film-coated tablets debossed with “93” on one side and “7314” on the other side.
Croatian: Svijetlo ružičaste do ružičaste filmom obložene tablete u obliku kapsula s utisnutom oznakom „93“ na jednoj i „7314“ na drugoj strani.
English: This is linked to the way your medicine works as it prevents the ability of blood clots to form.
Croatian: To je povezano s načinom na koji lijek djeluje jer sprječava mogućnost stvaranja krvnih ugrušaka.
English: For the 28x1 tablets pack size, you can check the day on which you last took a tablet of Clopidogrel Teva by referring to the calendar printed on the blister
Croatian: Za pakiranje od 28x1 tableta, možete provjeriti dan kada ste zadnji put uzeli tabletu Klopidogrel
English: Based on enrollment criteria, physicians enrolled patients in ACTIVE-W if they were candidates for vitamin K antagonist (VKA) therapy (such as warfarin).
Croatian: Na osnovi uključujućih kriterija liječnici su bolesnike uključivali u studiju ACTIVE-W ako su bili kandidati za terapiju antagonistima vitamina K (kao što je varfarin).
English: What Clopidogrel Teva is and what it is used for What you need to know before you take Clopidogrel Teva How to take Clopidogrel Teva Possible side effects
Croatian: Što je Klopidogrel Teva i za što se koristi Što morate znati prije nego što počnete uzimati Klopidogrel Teva Kako uzimati Klopidogrel Teva
English: • The active substance is clopidogrel.
Croatian: • Djelatna tvar je klopidogrel.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING BOTTLE LABEL (30 or 100 film-coated tablets)
Croatian: PODACI KOJE NAJMANJE MORA SADRŽAVATI UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI (30 ili 100 filmom obloženih tableta)
English: You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Clopidogrel Teva and acetylsalicylic acid for this condition.
Croatian: Trebalo Vam je biti rečeno da su za ovo stanje 'oralni antikoagulansi' učinkovitiji od acetilsalicilatne kiseline ili kombinirane primjene Klopidogrel
English: Clopidogrel and the main circulating (inactive) metabolite bind reversibly in vitro to human plasma proteins (98% and 94% respectively).
Croatian: Klopidogrel i glavni cirkulirajući (neaktivni) metabolit reverzibilno se in vitro vežu za proteine u ljudskoj plazmi (98%, odnosno 94%).
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excl. heparin, ATC Code: B01AC04.
Croatian: Farmakoterapijska skupina:Antitrombotici, inhibitori agregacije trombocita izuzev heparina, ATK oznaka: B01AC04.
English: The primary outcome, a composite of cardiovascular death, stroke, urgent revascularization, and
Croatian: Primarni ishod, koji se sastojao od kardiovaskularne smrti, moždanog udara, hitne revaskularizacije i
English: Teva Pharma Belgium N.V./S.A./AG Tel/Tél: +32 3 820 73 73
Croatian: Teva Pharma Belgium N.V./S.A. Tel/Tél: +32 3 820 73 73
English: If you forget to take a dose of Clopidogrel Teva, but remember within 12 hours of usual time,take your tablet straightaway and then take your next tablet at the usual time.
Croatian: Ako zaboravite uzeti jednu dozu Klopidogrela Teva, ali se toga sjetite u roku od 12 sati, odmah uzmite tabletu, a sljedeću tabletu uzmite u uobičajeno vrijeme.
English: If you become pregnant while taking Clopidogrel Teva, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Croatian: Ako zatrudnite za vrijeme uzimanja lijeka Klopidogrel Teva, odmah se posavjetujte s liječnikom jer nije preporučeno uzimati klopidogrel za vrijeme trudnoće.
English: • if you have kidney or liver disease.
Croatian: • ako imate bolest bubrega ili jetre
English: • Signs of liver problems such as yellowing of the skin and /or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Warnings and precautions').
Croatian: • znakove oštećenja funkcije jetre kao što su žuta boja kože ili očiju (žutica), bez obzira jesu li povezani s krvarenjem koje se pojavljuje kao crvene točkice ispod kože i/ili zbunjenošću (vidjeti dio 2. "Upozorenja i mjere opreza");
English: • Clopidogrel Teva is supplied in:
Croatian: Klopidogrel Teva dostupan je u:
English: Other medicines and Clopidogrel Teva
Croatian: Drugi lijekovi Klopidogrel Teva
English: Other alleles associated with absent or reduced metabolism are less frequent and include CYP2C19*4, *5, *6, *7, and *8.
Croatian: Ostali aleli povezani sa izostankom ili smanjenim metabolizmom uključuju CYP2C19*4, *5, *6, *7 i *8, ali oni su manje zastupljeni.
English: If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment.
Croatian: Ako ste imali jake bolove u prsištu (nestabilna angina ili srčani udar), liječnik Vam u početku liječenja može jednokratno dati 300 mg Klopidogrela Teva (1 tableta od 300 mg ili 4 tablete od po 75 mg).
English: The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY, COMMIT and ACTIVE-A studies are discussed below.
Croatian: Klinički značajne nuspojave opažene u studijama CAPRIE, CURE, CLARITY, COMMIT i ACTIVE-A opisane su u daljnjem tekstu.
English: In a relative bioavailability study in adults, the constituted solution of clopidogrel showed a similar extent and slightly higher rate of absorption of the main circulating (inactive) metabolite compared to the authorised tablet.
Croatian: U relativnoj studiji bioraspoloživosti lijeka u odraslih, konstituirana otopina klopidogrela pokazala je sličan raspon i neznatno veću brzinu apsorpcije glavnog cirkulirajućeg (neaktivnog) metabolita, u usporedbi s tabletom.
English: Each film-coated tablet contains 59.05 mg of lactose (as monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 59,05 mg laktoze ( u obliku monohidrata)