FrancophonIA/ELRC3.0 huggingface dataset:
English: However, injectable forms of these medicines can still be given for short-term obstetric use under specific conditions.
Croatian: No, injekcijski oblici ovih lijekova mogu se još uvijek primjenjivati u kratkoročnoj opstetričnoj primjeni u određenim okolnostima.
English: However, their use should be limited to pregnant women between 22 and 37 weeks of gestation and women receiving these medicines should be kept under specialist supervision for the duration of treatment, which is limited to a maximum of 48 hours.
Croatian: No, njihova primjena mora biti ograničena na trudnice između 22. i 37. tjedna gestacije, te žene u kojih se primjenjuje ovaj lijek moraju biti pod nadzorom specijaliste tijekom trajanja liječenja, koje je ograničeno maksimalno na 48 sati.
English: These medicines should no longer be used in oral or suppository forms in obstetric indications (for the care of pregnant women), such as for suppressing premature labour or excessive labour contractions.
Croatian: Ovi se lijekovi ne smiju više koristiti u oralnim oblicima ili kao čepići u opstetričnim indikacijama (za terapiju trudnica), poput primjerice za suzbijanje prijevremenog poroda ili prekomjernih porođajnih kontrakcija.
English: • Parenteral short-acting beta-agonists are effective in the short-term and they can still be used in all authorised obstetric indications (inhibition of premature labour, external cephalic version, emergency use in specified conditions).
Croatian: • Parenteralni kratkodjelujući beta-agonisti djelotvorni su kratkoročno i mogu se još uvijek koristiti u svim odobrenim opstetričnim indikacijama (inhibicija prijevremenog poroda, vanjska cefalična verzija, hitna primjena pod specifičnim uvjetima).
English: • These medicines can still be given intravenously (into a vein) to suppress premature labour, but their use is limited to a maximum of 48 hours, and only in women between the 22nd and the 37th weeks of pregnancy.
Croatian: • Ovi lijekovi se i dalje mogu primjenjivati intravenozno (u venu) za suzbijanje prijevremenog poroda, no njihova je primjena ograničena na maksimalno 48 sati i samo u žena između 22. i 37. tjedna trudnoće.
English: As the PRAC recommendations have been endorsed by consensus by the CMDh, they will now be implemented directly in all Member States, according to an agreed timetable.
Croatian: S obzirom da je CMDh konsenzusom potvrdio preporuku PRAC-a, sve države članice sada će izravno primijeniti preporuku u skladu s dogovorenim rasporedom.
English: In countries where injectable forms are also authorised for external cephalic version (a method for moving the baby into the right position for birth) and emergency use in specific conditions, the PRAC
Croatian: U državama u kojima su injekcijski oblici također odobreni za vanjsku cefaličku verziju (metodu pomicanje djeteta u ispravan položaj za porod) i hitnu primjenu u specifičnim uvjetima, PRAC je preporučio da ovi oblici ostanu
English: Therefore, the PRAC concluded that the benefits of injectable forms of these medicines continue to outweigh their risks when used under specific conditions: these medicines should only be used to suppress premature labour for up to 48 hours, between the 22nd and the 37th weeks of pregnancy and under specialist supervision with continuous monitoring of the mother and the unborn baby.
Croatian: Stoga je PRAC zaključio da koristi injekcijskih oblika ovih lijekova i dalje nadmašuju njihove rizike ako se koriste u specifičnim uvjetima: ovi se lijekovi trebaju koristiti samo za potiskivanje prijevremenog poroda do maksimalno 48 sati, između 22. i 37. tjedna trudnoće i uz kontinuirano praćenje majke i nerođenog djeteta od strane specijaliste.
English: They are available as tablets, oral solutions, solutions for injection or infusion, and suppositories.
Croatian: Dostupni su kao tablete, oralne otopine, otopine za injekciju i infuziju, te čepići.
English: These recommendations follow a review of available cardiovascular safety data on the medicines fenoterol, hexoprenaline, isoxsuprine, ritodrine, salbutamol and terbutaline when used in obstetric indications.
Croatian: Ove preporuke proizlaze na temelju pregleda dostupnih podataka o kardiovaskularnoj sigurnosti lijekova fenoterol, heksoprenalin, isoksuprin, ritodrin, sulbutamol i terbutalin kada se primjenjuju u opstetričnim indikacijama.
English: Oral and suppository formulations which are only authorised in obstetric indications will have their marketing authorisations revoked and shall be removed from the market by the Marketing Authorisation Holders by 25th November 2013 at the latest.
Croatian: Ukidaju se odobrenja za stavljanje lijeka u promet za oralne formulacije i formulacije čepića koje su odobrene samo u opstetričnim indikacijama, te iste nositelji odobrenja trebaju povući sa tržišta najkasnije do 25. studenog 2013. godine.
English: The medicines included in the EU review are: fenoterol, hexoprenaline, isoxsuprine, ritodrine, salbutamol and terbutaline, which have been authorised for tocolytic treatment (to suppress labour contractions).
Croatian: Sljedeći su lijekovi obuhvaćeni pregledom na razini EU: fenoterol, hekoprenalin, isoksuprin, ritodrin, salbutamol i terbutalin, koji su odobreni za tokolitičko liječenje (za inhibiranje porođajnih kontrakcija).
English: Smooth muscle is found in many organs, including on the inner linings of the airways, blood vessels, stomach and gut, and womb.
Croatian: Glatki mišić se nalazi u mnogim organima, uključujući i sluznicu dišnih putova, unutarnju prevlaku krvnih žila, želučanu sluznicu te unutarnje prevlake crijeva i maternice.
English: In addition to oral medicines and suppositories, this review also covered injectable short-acting betaagonists used as tocolytics.
Croatian: Uz peroralne lijekove i čepiće, ovaj pregled je također pokrio kratkodjelujuće beta-agoniste koji se ubrizgavaju i koriste kao tokolitici.
English: The PRAC concluded that there was a risk of serious cardiovascular side effects to both the mother and unborn baby when high-dose short-acting beta-agonists are used in obstetric indications, with the data suggesting these mostly occur with prolonged use.
Croatian: PRAC je zaključio da postoji rizik od ozbiljnih kardiovaskularnih nuspojava za majku i nerođeno dijete prilikom primjene velikih doza kratkodjelujućih beta-agonista u opstetričnim indikacijama, pri čemu podaci ukazuju da većina ovih nuspojava nastupa u slučaju produžene primjene.
English: • Parenteral short-acting beta-agonists should not be used in women with a history of heart disease or significant risk factors for heart disease or when prolongation of the pregnancy is hazardous to mother or fetus.
Croatian: • Parenteralni kratkodjelujući beta-agonisti ne smiju se primjenjivati u žena s anamnezom srčane bolesti ili značajnim faktorima rizika za srčanu bolest ili ako je produljenje trudnoće opasno za majku ili fetus.
English: • Given the identified cardiovascular adverse reaction profile and the very limited data supporting the benefits of oral forms and suppositories as short or long-term tocolytics, these formulations should no longer be used in any obstetric indication.
Croatian: • S obzirom na identificirani profil kardiovaskularnih nuspojava i vrlo skromne podatke koji podupiru koristi oralnih oblika i čepića kao kratkoročnih ili dugoročnih tokolitika, ove se formulacije više neće koristi u ikojoj opstetričnoj indikaciji.
English: Given the cardiovascular risk and the very limited data on the effectiveness of the oral and suppository forms of these medicines, the PRAC concluded that their benefit-risk balance is not favourable and these medicines should no longer be used in obstetric indications.
Croatian: S obzirom na kardiovaskularni rizik i vrlo skromne podatke o djelotvornosti ovih lijekova u oralnom obliku i kao čepića, PRAC je zaključio da omjer koristi i rizika nije povoljan te da se ovi lijekovi više ne smiju koristiti u opstetričnim indikacijama.
English: • High-dose short-acting beta-agonists are associated with a risk of serious adverse cardiovascular events to both the mother and the fetus, particularly when used for a prolonged period of time.
Croatian: • Kratkodjelujući beta-aginisti u velikim dozama povezani su s rizikom od ozbiljnih kardiovaskularnih nuspojava kako u majke tako i u fetusa, posebice ako se koriste tijekom produženog razdoblja.
English: • Because of a risk of problems affecting the heart and circulation to both the mother and unborn baby with high-dose short-acting beta-agonists, these medicines must not be used by mouth or as suppositories to suppress premature labour in pregnant women.
Croatian: • S obzirom na rizik od problema koji utječu na srce i krvožilni sustav majke i nerođenog djeteta uslijed primjene velike doze kratkodjelujućih beta-agonista, ovi se lijekovi ne smiju primjenjivati oralno ili kao čepići za suzbijanje prijevremenog poroda u trudnica.
English: The CMDh is a medicines regulatory body representing the European Union (EU) Member States recommended that they remain authorised in these indications.
Croatian: CMDh je regulatorno tijelo za lijekove koje predstavlja države članice Europske unije (EU).
English: These recommendations follow a review by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC), which looked into the known risk of cardiovascular side effects (problems affecting the heart and blood vessels) with high doses of short-acting beta-agonists when used as tocolytics (medicines that suppress labour contractions).
Croatian: Povjerenstvo je pregledalo poznate rizike kardiovaskularnih nuspojava (srčanih i krvožilnih problema) s velikim dozama kratkodjelujućih betaagonista u slučajevima kada se koriste kao tokolitici (lijekovi za suzbijanje porođajnih kontrakcija).
English: • Although these medicines are also used for the treatment of asthma, they are usually given at lower doses for this condition; if you are being treated with short-acting beta-agonists and have any questions or concerns about your treatment, speak to your doctor or pharmacist.
Croatian: Ako se liječite kratkodjelujućim beta-agonistima i imate bilo kakvih pitanja ili nedoumica u svezi s liječenjem, obratite se svojem liječniku ili ljekarniku.
English: Name Strength
Croatian: (Zaštićeno) ime
English: Its effects have not been studied beyond six weeks.
Croatian: Njegovo djelovanje nije ispitivano dulje od šest tjedana.
English: Similar results were seen in adults and in children.
Croatian: Slični su rezultati uočeni u odraslih osoba i djece.
English: It contains the active substance emedastine (0.5 mg/ml).
Croatian: Sadrže djelatnu tvar emedastin (0,5 mg/ml).
English: Emadine emedastine
Croatian: Emadine emedastin
English: The results of the allergen challenge tests supported these results.
Croatian: Rezultati testova alergenske provokacije govore u prilog ovim rezultatima.
English: Emadine is used in adults and children aged three years and older.
Croatian: Emadine se koristi u odraslih osoba i djece u dobi od tri godine i starijih.
English: If more than one type of eye treatment is being used, each one should be given at least 10 minutes apart and any eye ointments should be given last.
Croatian: Ako se koristi više od jednog tipa terapije za oči, svaku terapiju treba primjenjivati u razmaku od 10 minuta, a masti za oči treba koristiti zadnje.
English: Therefore, care should be taken by people who wear soft contact lenses.
Croatian: Stoga, osobe koje nose kontaktne leće moraju obratiti posebnu pozornost.
English: The main measure of effectiveness was the reduction in itching and redness, measured on a nine-point scale over up to six weeks.
Croatian: Glavna mjera djelotvornosti bilo je smanjenje svrbeži i crvenila, izmjereno na ljestvici od devet bodova tijekom razdoblja od šest tjedana.
English: The full EPAR for Emadine can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Emadine nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: These symptoms include itching, redness and swelling.
Croatian: Ti simptomi uključuju svrbež, crvenilo i oticanje.
English: Emadine is not recommended for patients older than 65 years or in patients who have problems with their liver or kidneys.
Croatian: Primjena lijeka Emadine ne preporučuje se u bolesnika starijih od 65 godina ili u bolesnika koji imaju problema s jetrom ili bubrezima.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Emadine on 27 January 1999.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Emadine vrijedi na prostoru Europske unije od 27. siječnja 1999.
English: Emadine is available in a bottle and in single-dose containers.
Croatian: Emadine je dostupan u bočici i u spremnicima za jednu dozu.
English: Other information about Emadine
Croatian: Ostale informacije o lijeku Emadine
English: The company also presented the results of studies in which patients received Emadine, levocabastine or placebo (a dummy treatment) before being subjected to an ‘allergen challenge'.
Croatian: Farmaceutska tvrtka također je predstavila rezultate ispitivanja u kojima su bolesnici primali lijek Emadine, levokabastin ili placebo (lažno liječenje), prije nego što su podvrgnuti „testu alergenske provokacije”.
English: This is a test where patients with an allergy who are not currently showing any allergic symptoms receive a defined dose of an allergen (the substance that they are allergic to) to trigger an allergic reaction.
Croatian: To je test u kojem bolesnici oboljeli od alergije, a koji trenutno ne pokazuju nikakve alergijske simptome, prime konačnu dozu alergena (tvari na koju su alergični) kako bi se aktivirala alergijska reakcija.
English: The active substance in Emadine, emedastine, is an antihistamine.
Croatian: Djelatna tvar lijeka Emadine, emedastin, je antihistamin.
English: Emadine is given as one drop in the affected eye(s) twice a day.
Croatian: Emadine se koristi kao jedna kapljica u bolesno(e) oko (oči) dvaput dnevno.
English: Emadine has been compared with levocabastine (another antihistamine) in one main study involving 222 patients with seasonal conjunctivitis aged four years and over.
Croatian: Emadine je uspoređen s levokabastinom (drugim antihistaminom) u jednom glavnom ispitivanju koje je obuhvatilo 222 bolesnika sa sezonskim konjuktivitisom u dobi od četiri godine i više.
English: For more information about treatment with Emadine, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Emadine pročitajte u uputama o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: When the receptors are blocked, histamine cannot have its effect, which leads to a decrease in the symptoms of allergy.
Croatian: Prilikom blokiranja receptora, histamin ne može djelovati što rezultira smanjenjem simptoma alergije.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Emadine.
Croatian: Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za uporabu lijeka Emadine.
English: The most common side effects with Emadine (which may affect between 1 and 2 patients in 100) are eye pain, eye pruritus (itchy eye) and conjunctival hyperaemia (increased blood flow to the eye, leading to redness).
Croatian: Najčešće nuspojave lijeka Emadine (koje su uočene u 1 do 2 bolesnika na 100 bolesnika) su bolne oči, pruritus oka (svrbež oka) i konjunktivalna hiperemija (povećani protok krvi u oku, što uzrokuje crvenilo).
English: In both groups of patients, itching scores fell from around 5.1 at the start of the study, to around 3.8 after five minutes and around 2.7 after two hours.
Croatian: U obje vrste bolesnika, rezultati svrbeži smanjili su se s otprilike 5,1 u početku ispitivanja na otprilike 3,8 nakon pet minuta te na otprilike 2,7 nakon dva sata.
English: For redness, the scores fell from around 2.7 to 0.5 for Emadine and to 1.1 for levocabastine.
Croatian: U slučaju crvenila rezultati su pali s otprilike 2,7 na 0,5 za lijek Emadine i na 1,1 za levokabastin.
English: The bottle form of Emadine contains benzalkonium chloride, which is known to discolour soft contact lenses.
Croatian: Lijek Emadine u bočici sadrži benzalkonijev klorid, za koji je poznato da mijenja boju mekanih leća.
English: What is the risk associated with Emadine?
Croatian: Koji su rizici povezani s lijekom Emadine?
English: This is a summary of the European public assessment report (EPAR) for Emadine.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Emadine.
English: Emadine is used to treat the symptoms of seasonal allergic conjunctivitis (inflammation of the eyes caused by pollen in patients with hayfever).
Croatian: Emadine se koristi za liječenje simptoma sezonskog alergijskog konjuktivitisa (upale očiju uzrokovane peludi u bolesnika s peludnom groznicom).
English: What is Emadine?
Croatian: Što je Emadine?
English: Emadine was as effective as levocabastine in reducing symptoms of seasonal conjunctivitis.
Croatian: Emadine je bio podjednako djelotvoran kao levokabastin u smanjivanju simptoma sezonskog konjuktivitisa.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Emadine's benefits are greater than its risks for the symptomatic treatment of seasonal allergic conjunctivitis.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučilo je da koristi od lijeka Emadine nadmašuju s njim povezane rizike za simptomatsko liječenje sezonskog alergijskog konjuktivitisa.
English: For the full list of all side effects and restrictions with Emadine, see the package leaflet.
Croatian: Potpun popis svih nuspojava i ograničenja s lijekom Emadine dostupan je u uputi o lijeku.
English: Emadine is a clear eye drop solution.
Croatian: Emadine su prozirne kapi za oči.
English: The Committee recommended that Emadine be given marketing authorisation.
Croatian: Povjerenstvo je preporučilo izdavanje odobrenja za stavljanje lijeka u promet za lijek Emadine.
English: In the long term, the itching scores fell from an average of around 3.9 on the first day, falling to 0.8 for Emadine and 2.0 for levocabastine after six weeks.
Croatian: Uočeno je i slično smanjenje u rezultatima crvenila koji su se smanjili prosječno s 3,9 prvoga dana na 0,8 s lijekom Emadine i 2,0 s lijekom levokabastin nakon šest tjedana.
English: Why has Emadine been approved?
Croatian: Zašto je lijek Emadine odobren?
English: What benefit has Emadine shown during the studies?
Croatian: Koje su koristi lijeka Emadine dokazane u ispitivanjima?
English: What is Emadine used for?
Croatian: Za što se Emadine koristi?
English: How is Emadine used?
Croatian: Kako se Emadine koristi?
English: It works by blocking the receptors that histamine normally attaches to. Histamine is a substance in the body that causes allergic symptoms.
Croatian: Djeluje blokirajući receptore na koje se histamin normalno vezuje.
English: How has Emadine been studied?
Croatian: Kako se Emadine ispitivao?
English: How does Emadine work?
Croatian: Kako djeluje Emadine?
English: Patients should be made aware of this.
Croatian: Pacijente o ovome treba informirati.
English: It is important that your hands and the items you use are as clean as possible.
Croatian: Važno je da Vaše ruke i predmeti koje koristite budu što čišći.
English: Do not use Ovitrelle if you notice any signs of deterioration, if the liquid contains particles or is not clear.
Croatian: Ako ne ugledate kapljicu (kapljice) tekućine na vrhu ili blizu vrha igle:
English: It is best to put it back into its original package.
Croatian: Najbolje je vratiti ju u originalno pakiranje.
English: Multiple pregnancy may lead to medical complications for you and your babies.
Croatian: Višestruke trudnoće mogu uzrokovati medicinske komplikacije za Vas i Vašu bebu.
English: Do not attempt to inject a second time.
Croatian: Ne pokušavajte injicirati drugi put.
English: Ask your pharmacist how to throw away medicines no longer used.
Croatian: Pitajte svog ljekarnika kako baciti lijekove koje više ne koristite.
English: Assemble everything you need.
Croatian: Pripremite sve što Vam je potrebno.
English: Switzerland
Croatian: Švicarska
English: • Gather everything you need and lay it out:
Croatian: • Pripremite sve što Vam je potrebno i položite na površinu:
English: Studies on carcinogenic potential were not performed.
Croatian: Ispitivanja kancerogenog potencijala nisu provedena.
English: The potential risk for humans is unknown.
Croatian: Nije poznat mogući rizik kod ljudi.
English: Inject under the skin, as you were taught.
Croatian: Injektirajte pod kožu, kao što Vam je objašnjeno.
English: • if you have unexplained vaginal bleeding
Croatian: • Ako imate neobjašnjivo vaginalno krvarenje.
English: Date of latest renewal: 02 February 2006
Croatian: Datum posljednje obnove odobrenja: 2. veljače 2006.
English: This instructions for use was last revised in:
Croatian: Ove upute za uporabu su zadnji puta revidirane u:
English: Do not use Ovitrelle if any of the above applies to you.
Croatian: Ne primjenjujte Ovitrelle ako se bilo što od gore navedenog odnosi na Vas.
English: Do not inject directly into a vein.
Croatian: Ne injektirajte izravno u venu.
English: If you are developing OHSS, you may be told not to have sex or to use a barrier contraceptive method for at least four days.
Croatian: Ako razvijate OHSS, možda će Vam reći da ne biste smjeli imati spolne odnose ili da biste trebali koristiti barijernu metodu kontracepcije tijekom najmanje četiri dana.
English: Dispose of all used items:
Croatian: Bacite sve korištene predmete:
English: Ask your doctor or pharmacist how to get a new needle.
Croatian: Upitajte svog liječnika ili ljekarnik kako možete nabaviti novu iglu.
English: • Malformations of sexual organs incompatible with pregnancy
Croatian: • Malformacije spolnih organa koje su nespojive s trudnoćom
English: This is justified, given the proteinous nature of the active substance and the negative outcome of the genotoxicity testing.
Croatian: To je opravdano, s obzirom na proteinsku građu djelatne tvari i negativan ishod testova genotoksičnosti.
English: The following definitions apply to the frequency terminology used hereafter: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalost pojavljivanja opisana je sljedećom terminologijom: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: However, the in-use stability has been demonstrated for 24 hours at + 2°C to 8°C.
Croatian: Međutim, dokazana stabilnost za primjenu je 24 sata na temperaturi +2 °C do 8 °C.
English: • Extrauterine pregnancy in the previous 3 months
Croatian: • Izvanmaternična trudnoća u prethodna 3 mjeseca
English: If you do not see any liquid, you may try a second time (you may do this a maximum of two times) starting from step 1 of section “If you do not see a tiny drop(s) of fluid at or near the tip” above.
Croatian: Ako ne vidite nikakvu tekućinu možete pokušati ponovno (ovo možete napraviti maksimalno dva puta) počevši od koraka 1 prethodno navedenog dijela „Ako ne ugledate kapljicu (kapljice) tekućine na vrhu ili blizu vrha igle“.
English: A comparative study between the freeze-dried and the liquid formulation showed bioequivalence between the two formulations.
Croatian: Komparativno ispitivanje između liofilizirane i tekuće formulacije pokazalo je bioekvivalenciju između tih dviju formulacija.