FrancophonIA/ELRC3.0 huggingface dataset:
English: Information on the use and licensing of ginkgo leaf medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o uporabi i odobrenju lijekova koji sadrže ginkov list u državama članicama EU-a treba zatražiti od nadležnih nacionalnih tijela.
English: Any applications for the licensing of medicines containing ginkgo leaf 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 ginkov list moraju se podnijeti nacionalnim tijelima nadležnim za lijekove, koja ocjenjuju zahtjeve za biljne lijekove i uzimaju u obzir znanstvene zaključke HMPC-a.
English: In its assessment, the HMPC considered a number of clinical studies with ginkgo leaf looking at its effectiveness in improving memory.
Croatian: HMPC je prilikom ocjene razmotrio niz kliničkih ispitivanja s ginkovim listom istražujući učinkovitost u poboljšanju pamćenja.
English: In patients who have a tendency to bleed or who use blood thinning medicines, ginkgo leaf medicines containing the dry extract should only be used after consulting a doctor.
Croatian: U bolesnika koji su skloni krvarenju ili koji koriste lijekove za razrjeđivanje krvi, lijekovi koji sadrže suhi ekstrakt ginkovog lista trebaju se koristiti nakon savjetovanja s liječnikom.
English: Further information on the HMPC assessment of ginkgo leaf 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 ginkov list, 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: Further information on the risks associated with ginkgo leaf 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 ginkov list, uključujući odgovarajuće mjere predostrožnosti za sigurnu uporabu, nalaze se u monografiji u rubrici „All documents” na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The dry extract is prepared using a technique to extract compounds from plant material by dissolving them in acetone which is then evaporated to obtain the dry extract.
Croatian: Suhi ekstrakt se priprema ekstrakcijom spojeva iz biljnog materijala otapanjem u acetonu koji se zatim uparava kako bi se dobio suhi ekstrakt.
English: For further information, see the HMPC assessment report.
Croatian: Za podrobnije informacije o ispitivanjima pogledajte izvješće HMPC-a o ocjeni lijeka.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing ginkgo leaf.
Croatian: Države članice EU-a uzimaju u obzir zaključke HMPC-a prilikom ocjenjivanja zahtjeva za odobrenje biljnih lijekova koji sadrže ginkov list.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of ginkgo leaf.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Povjerenstva za biljne lijekove (HMPC) u pogledu medicinske uporabe ginkovog lista.
English: At the time of the HMPC assessment, the most common side effect with ginkgo leaf medicines used for the treatment of mild dementia was headache (seen in more than 1 patient in 10).
Croatian: U trenutku ocjene HMPC-a, najčešća nuspojava lijekova koji sadrže ginkov list, korištenog u terapiji blage demencije bila je glavobolja (uočeno u više od 1 na 10 bolesnika).
English: The HMPC also concluded that, on the basis of their long-standing use, ginkgo leaf medicines containing the powdered leaf can be used for the relief of heaviness in the legs and the sensation of cold hands and feet that may occur with minor circulation problems.
Croatian: HMPC je zaključio da se, na temelju dugotrajne primjene, lijekovi koji sadrže ginkov list u prahu mogu koristiti za ublažavanje težine u nogama i osjećaja hladnoće u rukama i stopalima koji mogu nastupiti u slučaju manjih problema sa cirkulacijom.
English: How does ginkgo leaf work as a medicine?
Croatian: Kako ginkov list djeluje kao lijek?
English: The most relevant clinical trials performed in adults aged 50 years and above indicated that ginkgo leaf medicines containing the dry extract could have beneficial effects on cognitive function in mild dementia.
Croatian: Najznačajnija klinička ispitivanja provedena u odraslih osoba u dobi od 50 godina i starijih ukazuju da lijekovi koji sadrže suhi ekstrakt ginkovog lista mogu imati korisno djelovanje na kognitivnu funkciju u slučaju blage demencije.
English: Ginkgo leaf medicines containing these preparations are usually available in liquid and solid forms to be taken by mouth.
Croatian: Lijekovi koji sadrže ginkov list, u obliku navedenih pripravaka najčešće su dostupni u tekućim i krutim oblicima za primjenu kroz usta.
English: Ginkgo leaf medicines should only be used in adults.
Croatian: Lijekovi koji sadrže ginkov list smiju se koristiti samo u odraslih osoba.
English: The HMPC concluded that ginkgo leaf medicines containing the dry extract can be used to improve the age-related cognitive impairment (worsening of mental abilities) and quality of life of adults with mild dementia.
Croatian: HMPC je zaključio da se lijekovi koji sadrže suhi ekstrakt ginkovog lista mogu koristiti za poboljšanje kognitivnog oštećenja povezanog s dobi (pogoršanje mentalnih sposobnosti) i kvalitetom života u odraslih osoba s blagom demencijom.
English: Although clinical studies with ginkgo leaf medicines for minor circulation problems are available, they were too limited to be used as evidence and the HMPC conclusions for this indication are based on the medicines' long-standing use.
Croatian: Iako su klinička ispitivanja s lijekovima koji sadrže ginkov list u slučaju manjih problema s cirkulacijom dostupna, previše su ograničena da bi se koristila kao dokaz te se zaključci HMPC-a za ovu indikaciju temelje na dugotrajnoj primjeni lijeka.
English: Other information about ginkgo leaf medicines
Croatian: Ostale informacije o lijekovima koji sadrže ginkov list
English: These ginkgo leaf preparations can also be found in combination with other herbal substances in some herbal medicines.
Croatian: Ovi pripravci ginkovog lista dostupni su u kombinaciji s drugim biljnim tvarima u pojedinim biljnim lijekovima.
English: What is ginkgo leaf?
Croatian: Što je ginkov list?
English: For more information about treatment with ginkgo 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 ginkov list pročitajte u uputi o lijeku priloženoj uz lijek ili se obratite svom liječniku ili ljekarniku.
English: The HMPC conclusions on the use of ginkgo leaf medicines for minor circulation problems are based on their ‘traditional use'.
Croatian: Zaključci HMPC-a o primjeni lijekova koji sadrže ginkov list u slučaju manjih problema sa cirkulacijom temeljeni su na njihovoj "tradicionalnoj uporabi".
English: What are the risks associated with ginkgo leaf medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže ginkov list?
English: Detailed instructions on how to take ginkgo leaf medicines and who can use them can be found in the package leaflets that come with the medicines.
Croatian: Detaljne upute o načinu uzimanja lijekova koji sadrže ginkov list te tko ih može uzimati dostupne su u uputi o lijeku koja je priložena uz lijek.
English: The HMPC conclusions on the use of ginkgo leaf medicines to improve the age-related cognitive impairment and quality of life of adults with mild dementia are based on their ‘well-established use' in this indication.
Croatian: Zaključci HMPC-a o primjeni lijekova koji sadrže ginkov list za poboljšanje kognitivnih oštećenja povezanog s dobi i kvalitetom života u odraslih osoba s blagom demencijom temelji se na njihovoj "provjerenoj medicinskoj uporabi" u ovoj indikaciji.
English: What evidence supports the use of ginkgo leaf medicines?
Croatian: Koji dokazi potkrepljuju uporabu lijekova koji sadrže ginkov list?
English: For practical information about using ginkgo 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 ginkov list bolesnici trebaju pročitati priloženu uputu o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: Ginkgo leaf
Croatian: Ginkov list
English: How are ginkgo leaf medicines approved in the EU?
Croatian: Kako se u EU-u odobravaju lijekovi koji sadrže ginkov list?
English: Ginkgo leaf is the common name for the leaf of the plant Ginkgo biloba L. This summary covers ginkgo leaf medicines containing a specific herbal preparation made by powdering the dried leaf or as dry extract.
Croatian: Ginkov list je uobičajen naziv za list biljke Ginkgo biloba L.
English: 5 April 2016 EMA/823974/2015
Croatian: EMA/823974/2015
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: To znači da iako ne postoji dovoljno dokaza iz kliničkih ispitivanja, učinkovitost ovih biljnih lijekova je vjerojatna i postoje dokazi o njihovoj sigurnoj primjeni na opisani način tijekom najmanje 30 godina (uključujući najmanje 15 godina u EU).
English: Saw palmetto fruit should only be used in male adults and the elderly.
Croatian: Sabalov plod smije se koristiti samo u odraslih muškaraca i osoba starije dobi.
English: BPH is a non-cancerous increase in size of the prostate gland which surrounds the urethra, the tube that carries urine from the bladder out of the body.
Croatian: BPH je nekancerogeno povećanje žlijezde prostate koja okružuje uretru, cijev koja prenosi urin od mjehura do izlaska iz tijela.
English: If symptoms persist during the use of the medicine, a doctor or a qualified healthcare practitioner should be consulted.
Croatian: Ako se simptomi nastave tijekom primjene lijeka, potrebno je obratiti se liječniku ili kvalificiranom zdravstvenom radniku.
English: Common side effects (seen between 1 and 10 patients in 100) reported with saw palmetto fruit are abdominal (belly) pain and headache.
Croatian: Česte nuspojave (uočene u 1 do 10 na 100 bolesnika) prijavljene prilikom primjene sabalovog ploda jesu abdominalna bol (bol u trbuhu) i glavobolja.
English: Saw palmetto fruit is the common name for the fruit of the plant Serenoa repens (W. Bartram) Small.
Croatian: Sabalov plod je uobičajeni naziv za plodove biljke Serenoa repens (W. Bartram) Small.
English: Although a possible effect in relief of lower urinary tract symptoms related to BHP was observed, there were shortcomings in the studies such as too few patients and too short a treatment period.
Croatian: Iako je primijećen mogući učinak na ublažavanje simptoma donjeg mokraćnog sustava povezanih s BPH-om, ispitivanja su imala nedostatke, odnosno uključivala su premali broj bolesnika i razdoblje liječenja bilo je prekratko.
English: For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.
Croatian: Za detaljnije informacije o ispitivanjima koje je procijenio HMPC pogledajte izvješće HMPC-a o ocjeni lijeka.
English: The way saw palmetto fruit acts is not fully known, but from laboratory studies it is thought to work by reducing the action of male sex hormones such as testosterone, which play a role in causing enlargement of the prostate gland in BPH; and it may also have anti-inflammatory effects.
Croatian: Način na koji sabalov plod djeluje nije sasvim poznat, ali temeljem laboratorijskih ispitivanja smatra se da smanjuje djelovanje muških spolnih hormona, primjerice testosterona, koji utječu na povećanje prostate kod BPH-a, a može imati i protuupalni učinak.
English: Any applications for the licensing of medicines containing saw palmetto fruit 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 sabalov plod moraju se podnijeti nacionalnim tijelima nadležnima za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: Further information on the HMPC assessment of saw palmetto fruit 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 sabalov plod, uključujući pojedinosti zaključaka Povjerenstva, mogu se pronaći pod karticom „All documents” na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: How does saw palmetto fruit work as a medicine?
Croatian: Kako sabalov plod djeluje kao lijek?
English: Further information on the risks associated with saw palmetto fruit 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 povezanima s lijekovima koji sadrže sabalov plod, 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: This summary is not intended to provide practical advice on how to use medicines containing saw palmetto fruit.
Croatian: Svrha ovog sažetka nije davati praktične savjete o načinu primjene lijekova koji sadrže sabalov plod.
English: In its assessment, the HMPC considered a number of clinical studies with saw palmetto fruit hexane extract some of which showed that it is as effective as finasteride and tamsulosin (other medicines approved to treat BPH) at treating BPH symptoms for periods up to 1 year.
Croatian: Prilikom svoje ocjene HMPC je razmotrio niz kliničkih ispitivanja s heksanskim ekstraktom sabalovog ploda, od kojih su neka pokazala da je jednako učinkovit kao finasterid i tamsulozin (drugi odobreni lijekovi za liječenje BPH-a) u liječenju simptoma BPH-a za razdoblje do jedne godine.
English: The HMPC also concluded that, on the basis of its long-standing use, saw palmetto fruit (extracted with ethanol) can be used for the relief of lower urinary tract symptoms (such as difficulty starting urination or a frequent need to urinate) related to BPH, after serious conditions have been excluded by a doctor.
Croatian: HMPC je također zaključio da se na temelju njegove dugotrajne primjene, sabalov plod (ekstrahiran pomoću etanola) može koristiti za ublažavanje simptoma donjeg mokraćnog sustava (kao što su teškoće sa započinjanjem mokrenja ili česta potreba za mokrenjem) koji su povezani s BPH-om, nakon što je liječnik isključio ozbiljna stanja.
English: Information on the use and licensing of saw palmetto fruit medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o primjeni i davanju odobrenja za lijekove koji sadrže sabalov plod u državama članicama EU-a mogu se dobiti od nadležnih nacionalnih tijela.
English: Herbal medicines containing saw palmetto fruit are usually available in solid forms to be taken by mouth.
Croatian: Biljni lijekovi koji sadrže sabalov plod najčešće su dostupni u krutom obliku i uzimaju se kroz usta.
English: Saw palmetto fruit preparations may be obtained by using a technique to extract compounds from plant material by dissolving them in a solvent (hexane or ethanol), which is then partially evaporated to obtain a soft extract.
Croatian: Pripravci sabalovog ploda mogu se dobiti primjenom tehnike za ekstrakciju spojeva iz biljnog materijala otapanjem u otapalu (u heksanu ili metanolu) koje se zatim djelomično uparava kako bi se dobio gusti ekstrakt.
English: In its assessment, the HMPC also considered clinical studies with saw palmetto fruit ethanol extract.
Croatian: Prilikom svoje ocjene HMPC je razmotrio i klinička ispitivanja etanolnog ekstrakta sabalovog ploda.
English: The HMPC concluded that saw palmetto fruit (extracted with hexane) can be used to treat the symptoms of benign prostatic hyperplasia (BPH).
Croatian: HMPC je zaključio da se sabalov plod (ekstrahiran pomoću heksana) može koristiti za liječenje simptoma benigne hiperplazije prostate (BPH).
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing saw palmetto fruit.
Croatian: Države članice EU-a uzimaju u obzir zaključke HMPC-a prilikom ocjene zahtjeva za davanje odobrenja za biljne lijekove koji sadrže sabalov plod.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom instructions on how to take saw palmetto fruit medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Other information about saw palmetto fruit medicines
Croatian: Ostale informacije o lijekovima koji sadrže sabalov plod
English: For more information about treatment with saw palmetto fruit 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 sabalov plod pročitajte uputu o lijeku priloženu uz lijek, odnosno obratite se svom liječniku ili ljekarniku.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of saw palmetto fruit.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Povjerenstva za biljne lijekove (HMPC) u pogledu medicinske primjene sabalovog ploda.
English: For practical information about using saw palmetto fruit 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 sabalov plod bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svom liječniku ili ljekarniku.
English: What are the risks associated with saw palmetto fruit medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže sabalov plod?
English: What is saw palmetto fruit?
Croatian: Što je sabalov plod?
English: Saw palmetto fruit
Croatian: Sabalov plod
English: The HMPC conclusions on the use of ethanol-extracted saw palmetto fruit medicines for the relief of lower urinary tract symptoms related to BPH are based on their ‘traditional use' in this condition.
Croatian: Zaključci HMPC-a o primjeni lijekova koji sadrže sabalov plod za ublažavanje simptoma donjeg mokraćnog sustava povezanih s BPH-om temelje se na njihovoj „tradicionalnoj primjeni” kod tog stanja.
English: Therefore, the HMPC conclusions on the use of saw palmetto medicines are based on their long-standing use.
Croatian: Zaključci HMPC-a o lijekovima koji sadrže sabalov plod stoga se temelje na njihovoj dugotrajnoj primjeni.
English: The HMPC conclusions on the use of hexane-extracted saw palmetto fruit medicines for the symptomatic treatment of BPH are based on their ‘well-established use' in this condition.
Croatian: Zaključci HMPC-a o primjeni lijekova koji sadrže heksanski ekstrakt sabalovog ploda za simptomatsko liječenje BPH-a temelje se na „provjerenoj medicinskoj uporabi” kod tog stanja.
English: How are saw palmetto fruit medicines approved in the EU?
Croatian: Kako se u EU-u odobravaju lijekovi koji sadrže sabalov plod?
English: What evidence supports the use of saw palmetto fruit medicines?
Croatian: Kojim se dokazima potkrjepljuje primjena lijekova koji sadrže sabalov plod?
English: 23 January 2015
Croatian: 23. siječnja 2015.
English: It is available as capsules.
Croatian: Dostupan je kao kapsule.
English: Teysuno has been authorised in the EU since March 2011.
Croatian: Teysuno je odobren u EU-u od ožujka 2011.
English: What is Teysuno?
Croatian: Što je Teysuno?
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Croatian: Ako sudjelujete u kliničkom ispitivanju ili programu milosrdnog davanja lijekova te vam je potrebno više informacija o svom liječenju, obratite se liječniku koji vas liječi.
English: The full European Public Assessment Report for Teysuno can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Teysuno dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: On 6 January 2015, Nordic Group BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the indication for Teysuno.
Croatian: Dana 6. siječnja 2015., Nordic Group BV službeno je obavijestio Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoju prijavu za za odobrenje za stavljanje u promet lijeka Teysuno.
English: There are no consequences on the use of Teysuno in its authorised indication.
Croatian: Nema posljedica za korištenje lijeka Teysuno u odobrenoj indikaciji.
English: Tegafur is a ‘prodrug' that is converted in the body to another medicine called 5-fluorouracil (5-FU).
Croatian: Tegafur je „prolijek“ koji se u tijelu konvertira u drugi lijek naziva 5-fluorouracil (5-FU).
English: Teysuno contains the active substances tegafur, gimeracil and oteracil.
Croatian: Teysuno sadrži djelatne tvari tegafur, gimeracil i oteracil.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Croatian: Prijava je povučena nakon što je CHMP ocijenio dokumentaciju koju je tvrtka dostavila te je sastavio popis pitanja.
English: As a result, it prevents the growth of cancer cells and eventually kills them.
Croatian: Djelovanje lijeka rezultira sprječavanjem rasta stanica raka, te ih naposljetku ubija.
English: The two other active substances in Teysuno allow tegafur to be effective at lower doses and with fewer side effects: gimeracil by preventing the breakdown of 5-FU, and oteracil by reducing the activity of 5FU in normal, non-cancerous tissue in the gut.
Croatian: Druge dvije djelatne tvari lijeka Teysuno omogućuju tegafuru djelotvornost pri nižim dozama i s manje nuspojava: gimeracil sprječavajući razgradnju 5-FU i oteracil smanjujući djelovanje 5-FU u normalnom, nekancerogenom tkivu u crijevima.
English: What was Teysuno expected to be used for?
Croatian: Za što se Teysuno trebao koristiti?
English: 5-FU is similar to pyrimidine, a substance found in the genetic material of cells (DNA and RNA).
Croatian: 5-FU je sličan lijek pirimidinu, tvari koja je prisutna u genetičkom materijalu stanica (DNK i RNK).
English: It is used in combination with cisplatin (a platinum-based cancer medicine).
Croatian: Koristi se u kombinaciji s cisplatinom (lijekom protiv raka temeljenim na platini).
English: How is Teysuno expected to work?
Croatian: Kako je Teysuno trebao djelovati?