FrancophonIA/ELRC3.0 huggingface dataset:
English: Further information on the HMPC assessment of dried bilberry 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: Daljnje informacije o HMPC-ovoj ocjeni lijekova koji sadrže osušen plod borovnice, 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: Dried bilberry fruit can also be found in combination with other herbal substances in some herbal medicines.
Croatian: Osušen plod borovnice može postojati također i u kombinaciji s drugim biljnim tvarima u nekim biljnim lijekovima.
English: Further information on the risks associated with dried bilberry 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 povezanim s lijekovima koji sadrže osušen plod borovnice, 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: Any applications for the licensing of medicines containing dried bilberry 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 osušen plod borovnice moraju se podnijeti nacionalnim tijelima nadležnima za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of dried bilberry fruit.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Odbora za biljne lijekove (HMPC) u pogledu medicinske primjene sušenog ploda borovnice.
English: Information on the use and licensing of dried bilberry 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 osušen plod borovnice u državama članicama EU-a mogu se dobiti od nadležnih nacionalnih tijela.
English: This summary is not intended to provide practical advice on how to use medicines containing dried bilberry fruit.
Croatian: Svrha ovog sažetka nije davati praktične savjete o načinu primjene lijekova koji sadrže osušen borovničin plod.
English: What is dried bilberry fruit?
Croatian: Što je osušen borovničin plod?
English: Herbal medicines containing dried bilberry fruit are usually available as herbal tea to be drunk or used to rinse the mouth.
Croatian: Biljni lijekovi koji sadrže osušen plod borovnice najčešće su dostupni kao biljni čaj koji se pije ili koristi za ispiranje usta.
English: Other information about dried bilberry fruit medicines
Croatian: Ostale informacije o lijekovima koji sadrže osušen plod borovnice
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing dried bilberry fruit.
Croatian: Države članice EU-a uzimaju u obzir zaključke HMPC-a prilikom ocjene zahtjeva za davanje odobrenja za biljne lijekove koji sadrže osušen plod borovnice.
English: Detailed instructions on how to take dried bilberry fruit medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: Detaljne upute o načinu uzimanja lijekova koji sadrže osušen plod borovnice i o tome tko ih smije uzimati navedene su u uputi o lijeku koja je priložena uz lijek.
English: The HMPC conclusions on the use of dried bilberry fruit medicines for treating mild diarrhoea and minor inflammation of the lining of the mouth are based on their ‘traditional use'.
Croatian: Zaključci HMPC-a o primjeni lijekova koji sadrže osušen plod borovnice za liječenje blagog proljeva i blaže upale sluznice usne šupljine temelje se na njihovoj „tradicionalnoj primjeni”.
English: For more information about treatment with dried bilberry 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 osušen plod borovnice pročitajte uputu o lijeku priloženu uz lijek, odnosno obratite se svom liječniku ili ljekarniku.
English: What are the risks associated with dried bilberry fruit medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže osušen plod borovnice?
English: The HMPC noted the lack of clinical studies with dried bilberry fruit for these uses.
Croatian: HMPC je ukazao na manjak kliničkih ispitivanja sušenog ploda borovnice za navedene primjene.
English: Results from laboratory studies, although limited, indicate that the tannins in dried bilberry fruit have antimicrobial and astringent properties which can explain the traditional use of the dried fruit for treating mild diarrhoea and minor inflammation of the lining of the mouth.
Croatian: Rezultati ispitivanja provedenih u laboratoriju upućuju na to da tanini u sušenom plodu borovnice imaju antimikrobna svojstva i utječu na zatvaranje, što objašnjava tradicionalnu primjenu sušenog voća u liječenju blagog proljeva i blaže upale sluznice usne šupljine.
English: At the time of the HMPC assessment, no side effects had been reported with dried bilberry fruit medicines.
Croatian: U vrijeme kad je HPMC provodio ocjenu, nisu prijavljene nikakve nuspojave prilikom primjene lijekova koji sadrže osušen plod borovnice.
English: For practical information about using dried bilberry 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 osušen plod borovnice bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svom liječniku ili ljekarniku.
English: The HMPC concluded that, on the basis of its long-standing use, dried bilberry fruit can be used for the treatment of mild diarrhoea and minor inflammation of the lining of the mouth.
Croatian: Na temelju dugotrajne primjene, HMPC je zaključio da se osušen borovničin plod može koristiti za liječenje blagog proljeva i blaže upale sluznice usne šupljine.
English: How are dried bilberry fruit medicines approved in the EU?
Croatian: Kako se u EU-u odobravaju lijekovi koji sadrže osušen plod borovnice?
English: What evidence supports the use of dried bilberry fruit medicines?
Croatian: Kojim se dokazima potkrjepljuje primjena lijekova koji sadrže osušen plod borovnice?
English: Dried bilberry fruit is the common name for the dried fruit of the plant Vaccinium myrtillus L. Dried bilberry fruit preparations are obtained by comminuting (reducing into tiny pieces) the ripe, dry fruit.
Croatian: Osušen borovničin plod je uobičajen naziv za sušen plod biljke Vaccinium myrtillus L.
English: Similar analyses were performed.
Croatian: Provedene su slične analize.
English: The rest of the studies have been submitted in the form of published literature.
Croatian: Ostala su ispitivanja dostavljena u obliku objavljene literature.
English: LNG is a synthetic progestagen.
Croatian: LNG je sintetički progestagen.
English: UPA has been approved in 73 countries worldwide and it is being marketed for five years.
Croatian: UPA je odobren u 73 države širom svijeta te je na tržištu pet godina.
English: Ulipristal acetate (UPA)
Croatian: Ulipristal acetat (UPA)
English: Table 3: Meta-analysis on four clinical studies conducted with UPA
Croatian: Tabela 3: Meta-analiza četiri klinička ispitivanja provedena s UPA
English: For emergency contraception one tablet of 1.5 mg LNG needs to be taken, or two tablets of 0.75 mg LNG at once.
Croatian: Za potrebe hitne kontracepcije potrebno je uzeti jednu tabletu od 1,5 mg LNG-a ili dvije tablete od 0,75 mg LNG-a najednom.
English: N pregnancies 11
Croatian: N trudnoće 11
English: It is unknown what the explanation is for the contradicting results in both meta-analyses.
Croatian: Nije poznato pojašnjenje za ove kontradiktorne rezultate u obje meta analize.
English: Further, in all women emergency contraception should be taken as soon as possible after unprotected intercourse.
Croatian: Nadalje, u svih se žena hitna kontracepcija mora uzeti što je prije moguće nakon nezaštićenog odnosa.
English: N pregnancies 1
Croatian: N trudnoće 1
English: This is reflected in the wide range of estimates of prevented fraction across different studies.
Croatian: Ovo se odražava na veliki raspon procjena spriječene frakcije diljem različitih ispitivanja.
English: Further, the data of the two meta-analyses should be reflected in section 5.1 of the SmPC.
Croatian: Nadalje, podaci obje meta-analize moraju se prikazati u odjeljku 5.1 SPC-a.
English: However, the analyses are based on a limited number of women, especially in the highest body weight/BMI categories, which subsequently result in very wide and overlapping 95% confidence limits.
Croatian: No, analize se temelje na ograničenom broju žena, posebice u kategorijama s najvišom tjelesnom težinom/BMI-om, što posljedično rezultira vrlo širokim i preklapajućim 95% ograničenjima pouzdanosti.
English: Emergency contraceptives can be used to prevent an unintended pregnancy following an unprotected sexual intercourse or in case of failure of a contraceptive method.
Croatian: Hitni kontraceptivi mogu se koristiti za sprječavanje neželjene trudnoće nakon nezaštićenog seksualnog odnosa ili u slučaju neuspješnosti kontracepcijske metode.
English: The data used in the analyses of effect of UPA in relation to weight/BMI are partly based on the same studies two abovementioned studies for LNG, and another randomised controlled study (HRA2914-507, HRA2914-508, HRA2914-513) as well as an open label study (HRA2914-509).
Croatian: Podaci korišteni u analizama djelovanja UPA u odnosu na tjelesnu težinu/BMI djelomično se temelje na istim ispitivanjima dva prethodno navedena ispitivanja za LNG, te druga randomizirana kontrolirana ispitivanja (HRA2914-507, HRA2914-508, HRA2914-513) kao i otvorenom ispitivanju (HRA2914-509).
English: Dada OA et al. A randomized, double-blind, noninferiority study to compare two regimens of levonorgestrel for emergency contraception in Nigeria.
Croatian: A randomized, double-blind, noninferiority study to compare two regimens of levonorgestrel for emergency contraception in Nigeria.
English: The products are indicated for emergency contraception within 72 hours (3 days) of unprotected sexual intercourse or contraceptive failure, and have been approved in more than 100 countries worldwide and used for more than 30 years.
Croatian: Lijekovi su indicirani za hitnu kontracepciju unutar 72 sata (3 dana) od nezaštićenog seksualnog odnosa ili neuspješne kontracepcije, te su odobreni u više od 100 država širom svijeta i koriste se dulje od 30 godina.
English: Pregnancy rate 1.56% 0.96% 2.36% 5.19% Confidence
Croatian: Stopa trudnoća 1,56% 0,96% 2,36% 5,19% Pouzdanost
English: Ulipristal acetate (UPA) (30 mg) (ellaOne) is an orally synthetic progesterone receptor modulator, which acts via high affinity binding to the human progesterone receptor.
Croatian: Ulipristal acetat (UPA) (30 mg) (ellaOne) jest oralni sintetički modulator receptora progesterona, koji djeluje zahvaljujući velikoj sklonosti vezivanja na ljudski receptor progesterona.
English: All together, the current data are considered not robust enough to support the current recommendation of decreased efficacy in women with body weight above 75 kg and inefficacy in women with body weight above 80 kg as is currently included in the product information of one LNG-containing emergency contraceptive medicinal product (Norlevo).
Croatian: Sveukupno, aktualni podaci se ne smatraju dovoljno čvrstima kako bi se podržale aktualne preporuke za smanjenu djelotvornost u žena s tjelesnom težinom većom od 75 kg i nedjelotvornosti u žena s tjelesnom težinom većom od 80 kg kako je trenutno uključeno u informacije o proizvodu jednog hitnog kontraceptiva koji sadrži LNG (Norlevo).
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for the emergency contraceptive medicinal products containing LNG or UPA.
Croatian: • je Povjerenstvo razmotrilo postupak sukladno članku 31. Direktive 2001/83/EC za hitne kontraceptive koji sadrže LNG ili UPA.
English: 2 von Hertzen H et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO
Croatian: Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO
English: Available data should be included in the product information, but no restrictions of use based on body weight/BMI are recommended at this stage.
Croatian: Dostupni podaci moraju biti uključeni u informacije o proizvodu, no bez ograničenja u primjeni na temelju tjelesne težine/BMI-a kako je preporučeno u ovoj fazi.
English: Annex II Scientific conclusions and grounds for variation to the terms of the marketing authorisations
Croatian: Znanstveni zaključci i razlozi za izmjenu uvjeta odobrenja za stavljanje proizvoda u promet
English: From these data there is no clear indication of an effect of weight or BMI on efficacy in general, or specifically among overweight or obese women.
Croatian: Iz ovih podataka nema jasne indikacije djelovanja tjelesne težine ili BMI-a na djelotvornost općenito ili posebice među ženama s prekomjernom težinom ili gojaznim ženama.
English: Pregnancy rate 1.83% 0.99% 0.57% 1.17% Confidence
Croatian: Stopa trudnoća 1,83% 0,99% 0,57% 1,17% Pouzdanost
English: On 16 January 2014 the Swedish Agency sent a notification for a referral under Article 31 of directive 2001/83 EC regarding all emergency contraceptives containing LNG or UPA asking the CHMP to give its opinion on whether the marketing authorisations should be maintained, varied, suspended or withdrawn.
Croatian: Dana 16. siječnja 2014., Švedska agencija uputila je obavijest o postupku upućivanja sukladno članku 31. Direktive 2001/83 EZ vezano uz sve hitne kontraceptive koji sadrže LNG ili UPA tražeći od CHMP njihovo mišljenje o tome trebaju li se odobrenja za stavljanje lijekova u promet zadržati, izmijeniti, suspendirati ili povući.
English: Benefit -risk balance
Croatian: Omjer koristi i rizika
English: While the analyses of data from the three randomised controlled trials in which 2,098 women received UPA indicate a weak effect of body weight or BMI on pregnancy rates, the open label study (n=1,241) indicated no such effect.
Croatian: Iako analize podataka iz tri randomizirana kontrolirana ispitivanja, u kojih je 2.098 žena primilo UPA ukazuju na slabo djelovanje tjelesne težine ili BMI-a na stope trudnoće, otvoreno ispitivanje (n=1,241) nije indikativno za takvo djelovanje.
English: In the meta-analysis including the three WHO studies, primarily including African and Asian women, no trend for a reduced efficacy with increasing body weight/BMI was observed (Table 1).
Croatian: U meta-analizi koja je obuhvatila tri WHO ispitivanja, koja su primarno provedena na afrikankama i azijatkinjama, nije uočen trend u smanjivanju djelotvornosti s povećavanjem tjelesne težine/BMI (tabela 1.).
English: In particular, limited but inconclusive data suggest that there may be reduced efficacy of these medicinal products with increased body weight in women.
Croatian: Posebice, skromni, no neuvjerljivi podaci ukazuju na mogućnost smanjene djelotvornosti ovih lijekova s povišenom tjelesnom težinom u žena.
English: The product is indicated for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.
Croatian: Lijek je indiciran za hitne slučajeve kontracepcije unutar 120 sati (5 dana) od nezaštićenog seksualnog odnosa ili neuspješne kontracepcije.
English: The data are currently too limited and therefore insufficiently precise to draw definite conclusions whether efficacy is negatively influenced by increased body weight and BMI; for instance for the obese category (BMI ≥30) three pregnancies were reported in the first analysis, and eleven pregnancies in the second.
Croatian: Podaci su trenutno preskromni te su stoga nedovoljno precizni za donošenje konačnih zaključaka o negativnom utjecaju na djelotvornost koji je posljedica povišene tjelesne težine i BMI-a; primjerice u slučaju kategorije gojaznih žena (BMI ≥30) prijavljene su tri trudnoće u prvoj analizi, te jedanaest trudnoća u drugoj.
English: A range of different factors have an impact on a woman´s fertility and the ability of emergency contraceptives to prevent a pregnancy, e.g. timing of intake of emergency contraception in relation to intercourse, conception probability, further acts of unprotected intercourse, age, ethnicity, previous infections of the genital tract, male fertility, etc.
Croatian: Na žensku plodnost utjecaj ima cijeli raspon različitih čimbenika, a sposobnost hitnih kontraceptiva za sprječavanje trudnoće, primjerice pravovremeni unos hitnog kontracepcijskog sredstva u odnosu na seksualni odnos, izglednost začeća, daljnji nezaštićeni odnosi, dob, etnička pripadnost, prethodne infekcije genitalnog trakta, muška plodnost, itd.
English: 1 von Hertzen H et al. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception.
Croatian: Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception.
English: In the three WHO studies (Von Hertzen et al., 1998 and 2002; Dada et al., 2010) no trend for a reduced efficacy with increasing body weight/BMI was observed, whereas in the two other studies (Creinin et al., 2006 and Glasier et al., 2010) a reduced contraceptive efficacy was observed with increasing body weight or BMI.
Croatian: U tri ispitivanja provedena od strane WHO-a (Von Hertzen et al., 1998. i 2002.; Dada et al., 2010.) nije uočen trend za smanjenu djelotvornost s povišenom tjelesnom težinom/BMI-om, dok je u dva druga ispitivanja (Creinin et al., 2006. i Glasier et al., 2010.) uočena smanjena djelotvornost kontraceptiva s povišenjem tjelesne težine i BMI-om.
English: 5 Glasier A et al. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomized noninferiority trial and meta-analysis.
Croatian: Ulipristal acetate versus levonorgestrel for emergency contraception: a randomized noninferiority trial and meta-analysis.
English: Considering the need to further characterise this risk, the MAHs are strongly recommended to investigate the pharmacodynamic effect (ovulation inhibition) of LNG in obese women in the future.
Croatian: Uzimajući u obzir potrebu za daljnjom karakterizacijom ovog rizika, nositelji odobrenja izričito su preporučili istraživanje farmakodinamičkog djelovanja (inhibicije ovulacije) LNG-a u gojaznih žena u buduće.
English: The emergency contraceptives can be divided into levonorgestrel (LNG)- and ulipristal acetate (UPA)-containing emergency contraceptives and they act by inhibiting and/or delaying ovulation.
Croatian: Hitni kontraceptivi mogu se podijeliti na hitne kontraceptive koji sadrže levonorgestrel (LNG) i ulipristal acetat (UPA), a djeluju inhibirajući ili/i odgađajući ovulaciju.
English: Creinin MD et al. Progesterone receptor modulator for emergency contraception: a randomized controlled trial.
Croatian: Progesterone receptor modulator for emergency contraception: a randomized controlled trial.
English: Grounds for the variation to the terms of the marketing authorisation Whereas
Croatian: Razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet Budući da
English: Further, since the limited data available do not support with any certainty the conclusion that their contraceptive effect is reduced in women with high bodyweight, no adjustment of the dose is recommended at this stage, and any information that already is included in the section 4.2 of the SmPC making reference to effect and body weight should be removed.
Croatian: Nadalje, budući da skromni dostupni podaci ne podržavaju s određenom dozom sigurnosti zaključak da je njihovo kontracepcijsko djelovanje smanjeno u žena s povišenom tjelesnom težinom, u ovoj fazi se ne preporuča prilagođavanje doze, a bilo koje informacije koje su već uključene u odjeljku 4.2. SPC-a, koje navode povezanost djelovanja i tjelesne težine, moraju se ukloniti.
English: The use of emergency contraception is an occasional method that is far less effective compared with most contraceptive products used on a regular basis, e.g. combined hormonal contraceptives, gestagen-only pills and various long-acting methods like intra-uterine devices and implants.
Croatian: Primjena hitne kontracepcije je privremena metoda koja je manje učinkovita u usporedbi s kontracepcijskim proizvodima koji se koriste na redovitoj bazi, primjerice hormonalni kontraceptivi, tablete koje sadrže samo gestagen i različite dugodjelujuće metode poput proizvoda koji se ugrađuju u rodnicu i implantata.
English: Overall summary of the scientific evaluation of emergency contraceptives medicinal products containing levonorgestrel or ulipristal acetate
Croatian: Cjelokupan sažetak znanstvene ocjene hitnih kontracepcijskih lijekova koji sadrže levonorgestrel ili ulipristal acetat
English: In addition the CHMP is of the opinion that conducting a pharmacodynamic/pharmacokinetic (PD/PK) study may provide some information which may help to further characterise the risk of decreased efficacy in women with high body weight/BMI and ovulation inhibition.
Croatian: Nadalje, CHMP je mišljenja da provođenje farmakodinamičkog/farmakokinetičkog (FD/FK) ispitivanja može pružiti informacije koje mogu pomoći u daljnjem karakteriziranju rizika smanjene djelotvornosti u žena s prekomjernom tjelesnom težinom/BMI-om i inhibicijom ovulacije.
English: Pregnancy rate 0.00% 1.23% 1.29% 2.57%
Croatian: N trudnoće Stopa trudnoća 0,00% 1,23% 1,29% 2,57%
English: A trend was observed in the UPA group for increasing number of pregnancies with increasing weight or BMI.
Croatian: Uočen je trend u grupi koja je uzimala UPA s povećanim brojem trudnoća u slučaju povišene tjelesne mase ili povišenog BMI-a.
English: Both meta-analyses excluded off-label use of LNG-containing of emergency contraceptives, i.e. intake later than 72 hours after unprotected intercourse and women who had further acts of unprotected intercourse.
Croatian: Obje meta-analize isključile su primjenu hitnih kontraceptiva koji sadrže LNG mimo indikacije, odnosno unos nakon 72 sata nakon nezaštićenog odnosa i u žena koje su imale daljnje nezaštićene odnose.
English: • The CHMP concluded that the available data is limited and does not support a definite conclusion that increased bodyweight reduces efficacy of emergency contraceptives medicinal products containing LNG or UPA.
Croatian: • je CHMP zaključio da su dostupni podaci skromni i ne podržavaju donošenje konačnih zaključaka da povišena tjelesna težina smanjuje djelotvornost hitnih kontraceptiva koji sadrže LNG ili UPA.
English: Overall conclusion
Croatian: Ukupan zaključak
English: Therefore, even if data from some studies suggest a lower ability of LNG-containing emergency contraceptives to prevent pregnancies in women of higher weight/BMI, this is only one factor influencing the effect and it is difficult to define a certain cut-off for weight/BMI at which no effect is present.
Croatian: Stoga, čak i kada podaci iz različitih ispitivanja ukazuju na smanjenu sposobnost kontraceptiva koji sadrže LNG u sprječavanju trudnoća u žena povišene tjelesne težine /BMI-a, to je samo jedan čimbenik koji utječe na djelovanje te je teško definirati određenu graničnu vrijednost za tjelesnu težinu/BMI, u kojoj djelovanje nije prisutno.
English: Table 2: Meta-analysis on studies of Creinin et al., 2006 and Glasier et al., 2010
Croatian: Tabela 2: Meta-analiza ispitivanja Creinin et al., 2006. i Glasier et al., 2010.