FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients taking certain medicines, including some medicines for HIV infection,
Croatian: Liječnik može preporučiti nižu početnu dozu u bolesnika koji uzimaju određene lijekove, uključujući neke lijekove za liječenje infekcije HIV-om, tuberkuloze ili gljivičnih infekcija.
English: How is Adempas used?
Croatian: Kako djeluje Adempas?
English: For the full list of side effects with Adempas, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Adempas potražite u uputi o lijeku.
English: MA (EU) number (Invented) name
Croatian: Broj (EU) odobrenja(Zaštićeno) ime Doza
English: Route of Administration Immediate Packaging Pack size
Croatian: Put primjene Unutarnje pakovanje Veličina pakovanja blister (PVC/PE/PVdC-Alu) 84 tableta
English: Some patients also have episodes of severe muscle weakness (cataplexy) that can cause collapse.
Croatian: Neki bolesnici također imaju epizode teške slabosti mišića (katapleksija) koje mogu uzrokovati kolaps.
English: Wakix is available as tablets (4.5 and 18 mg).
Croatian: Wakix je dostupan u obliku tableta (od 4,5 i 18 mg).
English: Serious but rare side effects are abnormal loss of weight and spontaneous abortion.
Croatian: Ozbiljne, ali rijetke nuspojave su abnormalan gubitak težine i spontani pobačaj.
English: Results from this study also showed a decrease in the number of cataplexy attacks.
Croatian: Rezultati tog ispitivanja također su ukazivali na smanjen broj napada katapleksije.
English: This leads to symptoms such as an irresistible urge to sleep, even at inappropriate times and places, and disturbed night-time sleep.
Croatian: To dovodi do simptoma kao što su neodoljiva potreba za spavanjem, čak i u neprikladno vrijeme i na neprikladnim mjestima te poremećen noćni san.
English: The most common side effects with Wakix (which may affect up to 1 in 10 people) are insomnia (difficulty sleeping), headache, nausea (feeling sick), anxiety, irritability, dizziness, depression, tremor, sleep disorders, tiredness, vomiting, vertigo (a spinning sensation) and dyspepsia (heartburn).
Croatian: Najčešće nuspojave lijeka Wakix (mogu se javiti u do 1 na 10 osoba) su nesanica (teškoće sa spavanjem), glavobolja, mučnina (osjećaj slabosti), tjeskoba, razdražljivost, ošamućenost, depresija, tremor, poremećaji sna, umor, povraćanje, vrtoglavica (osjećaj vrtnje) i dispepsija (žgaravica).
English: This increases the activity of certain brain cells called ‘histamine neurons', which are important for keeping the body awake.
Croatian: To povećava aktivnost određenih stanica mozga koje se nazivaju „histaminski neuroni”, a koje su važne za održavanje tijela budnim.
English: Narcolepsy is a long-term sleep disorder which affects the brain's ability to regulate the normal sleep-wake cycle.
Croatian: Narkolepsija je dugoročan poremećaj spavanja koji utječe na sposobnost mozga da regulira normalni ciklus budnost-spavanje.
English: During the first week of treatment, the recommended dose is 9 mg per day, taken in the morning during breakfast.
Croatian: Preporučena doza tijekom prvog tjedna liječenja je 9 mg na dan, a uzima se ujutro uz doručak.
English: Wakix should always be used at the lowest effective dose.
Croatian: Wakix uvijek treba koristiti tako da se uzima najmanja učinkovita doza.
English: In addition, Wakix works differently from currently available treatments and therefore offers an alternative treatment option.
Croatian: Osim toga, Wakix djeluje na drugačiji način u odnosu na trenutno dostupne terapije i stoga pruža alternativno rješenje za liječenje.
English: This is a standard scale used in patients with narcolepsy which ranges from 0 to 24.
Croatian: To je standardna ljestvica koja se koristi u bolesnika s narkolepsijom čiji je raspon od 0 do 24.
English: Wakix has been investigated in 2 main studies involving a total of 261 adults with narcolepsy, the majority of whom also had cataplexy.
Croatian: Wakix je ispitivan u okviru dvaju glavnih ispitivanja koja su uključivala ukupno 261 odraslu osobu s narkolepsijom, pri čemu je većina imala katapleksiju.
English: Wakix is a medicine used to treat adults with narcolepsy.
Croatian: Wakix je lijek koji se koristi za liječenje odraslih osoba s narkolepsijom.
English: During the second week of treatment, the dose can be increased to 18 mg per day or decreased to 4.5 mg per day.
Croatian: Tijekom drugog tjedna liječenja doza se može povećati na 18 mg na dan ili smanjiti na 4,5 mg na dan.
English: The second study, however, did not show a difference between Wakix and placebo at reducing sleepiness or cataplexy.
Croatian: Međutim, drugo ispitivanje nije pokazalo razliku između Wakixa i placeba u smanjenju pospanosti ili katapleksije.
English: What measures are being taken to ensure the safe and effective use of Wakix?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Wakix?
English: In patients with moderately reduced liver function or with kidney problems, the maximum dose should be 18 mg per day.
Croatian: U bolesnika s umjereno smanjenom funkcijom jetre ili u bolesnika s problemima s bubrezima najveća moguća doza mora biti 18 mg na dan.
English: In addition, the company that markets Wakix will carry out an observational study to collect information on the safety of the medicine when used in medical practice.
Croatian: Osim toga, tvrtka koja Wakix stavlja na tržište provest će opservacijsko ispitivanje radi prikupljanja informacija o sigurnosti primjene lijeka u medicinskoj praksi.
English: This is a summary of the European public assessment report (EPAR) for Wakix.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Wakix.
English: The overall data available demonstrate that Wakix has a positive effect on the two major symptoms of narcolepsy, excessive daytime sleepiness and cataplexy.
Croatian: Svi dostupni podaci pokazuju da Wakix ima pozitivan učinak na dva glavna simptoma narkolepsije, prekomjernu pospanost preko dana i katapleksiju.
English: What is Wakix and what is it used for?
Croatian: Što je Wakix i za što se koristi?
English: When looking at sleepiness with an objective test called Maintenance of Wakefulness Test or MWT, the results of the two studies together showed that Wakix significantly improved wakefulness compared with placebo.
Croatian: Prilikom razmatranja pospanosti uz pomoć objektivnog testa koji se naziva test održavanja budnosti, odnosno MWT, ukupni rezultati obaju ispitivanja pokazala su da Wakix znatno povećava budnost u odnosu na placebo.
English: Other information about Wakix
Croatian: Ostale informacije o lijeku Wakix
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Wakix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Wakix dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Because the number of patients with narcolepsy is low, the disease is considered ‘rare', and Wakix was designated an ‘orphan medicine' (a medicine used in rare diseases) on 10 July 2007.
Croatian: S obzirom na mali broj bolesnika koji boluju od narkolepsije, ta se bolest smatra „rijetkom” te se Wakix označava kao lijek za liječenje rijetkih bolesti od 10. srpnja 2007.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Wakix's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji stoga je odlučio da koristi od lijeka Wakix nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: The active substance in Wakix, pitolisant, works by attaching to receptors in the brain called ‘histamine H3 receptors'.
Croatian: Djelatna tvar u lijeku Wakix, pitolisant, djeluje tako da se veže za receptore u mozgu koji se nazivaju „histaminski H3 receptori”.
English: The safety profile of Wakix is considered acceptable, with no major safety concerns identified.
Croatian: Sigurnosni profil lijeka Wakix smatra se prihvatljivim jer nisu utvrđeni elementi koji bi ukazivali na ozbiljnu zabrinutost u pogledu sigurnosti.
English: The full EPAR and risk management plan summary for Wakix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Wakix nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Wakix is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Wakix.
English: The main measure of effectiveness was based on how sleepy patients felt during daytime, assessed using the Epworth Sleepiness Scale or ESS.
Croatian: Glavna mjera učinkovitosti temeljila se na tome kako su se bolesnici osjećali tijekom dana, što se procjenjivalo uz pomoć Epworthove ljestvice pospanosti odnosno ESS-a.
English: Wakix can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of sleep disorders.
Croatian: Wakix se izdaje samo na liječnički recept i liječenje mora započeti liječnik s iskustvom u liječenju poremećaja sna.
English: It is not intended to provide practical advice on how to use Wakix.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Wakix.
English: the dose may be further increased to the maximum dose of 36 mg per day.
Croatian: Tijekom trećeg tjedna liječenja doza se može dodatno povećati na najveću moguću dozu od 36 mg na dan.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Wakix, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Wakix nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: What are the risks associated with Wakix?
Croatian: Koji su rizici povezani s lijekom Wakix?
English: For more information about treatment with Wakix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Wakix pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Wakix contains the active substance pitolisant.
Croatian: Wakix sadrži djelatnu tvar pitolisant.
English: Wakix is used in patients with or without cataplexy.
Croatian: Wakix se primjenjuje u bolesnika koji imaju ili nemaju katapleksiju.
English: The studies compared Wakix with placebo (a dummy treatment).
Croatian: Wakix je u ispitivanjima uspoređivan s placebom (prividnim liječenjem).
English: Why is Wakix approved?
Croatian: Zašto je lijek Wakix odobren?
English: Wakix must not be used in patients with severely reduced liver function and in women who are breastfeeding.
Croatian: Wakix se ne smije primjenjivati u bolesnika s ozbiljno smanjenom funkcijom jetre te u dojilja.
English: For practical information about using Wakix, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Wakix pročitajte u uputi o lijeku ili se obratite svom liječniku ili ljekarniku.
English: What benefits of Wakix have been shown in studies?
Croatian: Koje su koristi lijeka Wakix utvrđene u ispitivanjima?
English: How does Wakix work?
Croatian: Kako djeluje Wakix?
English: How is Wakix used?
Croatian: Kako se Wakix koristi?
English: In a further study in 105 patients with narcolepsy and cataplexy, Wakix was also more effective than placebo at reducing the number of cataplexy attacks per week: the number of cataplexy attacks decreased from around 9 to around 3 per week in patients taking Wakix, while it remained at around 7 per week in patients taking placebo.
Croatian: U dodatnom ispitivanju na 105 bolesnika s narkolepsijom i katapleksijom Wakix se također pokazao učinkovitijim od placeba u smanjenju broja tjednih napadaja katapleksije.
English: The first study showed that Wakix was more effective than placebo at reducing daytime sleepiness: patients taking Wakix had an average reduction of 3 points more in the ESS scale than those taking placebo after 8 weeks of treatment.
Croatian: Nakon 8 tjedana liječenja, kod bolesnika koji su uzimali Wakix zabilježeno smanjenje na ljestvici EES bilo je prosjeku veće za 3 boda u odnosu na bolesnike koji su uzimali placebo.
English: For the full list of all side effects reported with Wakix, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Wakix potražite u uputi o lijeku.
English: 0.6 ml (10 mg/ml) 1 pre-filled syringe
Croatian: 0.6 ml (10 mg/ml) 1 napunjena štrcaljka
English: Subcutaneous use pre-filled syringe (glass)
Croatian: Supkutano napunjena štrcaljka (staklena)
English: 31 July 2014
Croatian: 31. srpnja 2014.
English: The referral started on 6 November 2013.
Croatian: Postupak upućivanja započet je 6. studenog 2013.
English: International non-proprietary name (INN): tylosin
Croatian: Međunarodni nezaštićeni naziv (INN): tilozin
English: Article 35 of Directive 2001/82/EC, as amended
Croatian: Direktive 2001/82/EZ, s dopunama
English: The final opinion was converted into a Decision by the European Commission on 31 July 2014.
Croatian: Europska Komisija usvojila je konačno mišljenje u obliku Odluke dana 31. srpnja 2014.
English: The Committee appointed E. Persson as rapporteur and A. Wachnik-Święcicka as co-rapporteur.
Croatian: Persson kao izvjestitelja i A. Wachnik-Święcicka kao pomoćnog izvjestitelja.
English: Veterinary Medicines Division
Croatian: Odjel za veterinarsko medicinske proizvode
English: The CVMP was requested to consider whether tylosin is still effective against swine dysentery (caused by Brachyspira hyodysenteriae) and whether the treatment durations beyond three weeks are justified.
Croatian: Od CVMP-a je zatraženo da donese zaključak je li tilozin još uvijek djelotvoran protiv svinjske dizenterije (uzrokovane bakterijom B. hyodysenteriae) te je li opravdano trajanje liječenja dulje od tri tjedna.
English: Tylosin is a macrolide antibiotic which is produced by Streptomyces fradiae.
Croatian: Tylosin je makrolidni antibiotik koji proizvode bakterije Streptomyces fradiae.
English: Opinion following an Article 35
Croatian: Članak 35.
English: Based on the evaluation of the currently available data, the CVMP considered that the overall benefitrisk profile for these products remains positive subject to amendments in the product information.
Croatian: Na temelju ocjene dostupnih podataka, CVMP je zaključio kako je omjer koristi i rizika za predmetne veterinarsko-medicinske proizvode ostaje pozitivan, te je predmetom dopuna informacija o proizvodu.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in Annex III.
Croatian: Znanstveni zaključci su navedeni u Dodatku II zajedno s dopunama u sažetcima opisa svojstava proizvoda, etiketama i uputama o lijeku u Dodatku III.
English: Written comments on the recommendations and proposed changes in the product information were provided by the applicants and marketing authorisation holders on 7 March 2014.
Croatian: Podnositelji zahtjeva i nositelji odobrenja za stavljanje VMP-a u promet dostavili su dana 07. ožujka 201. pisane komentare o preporukama i predloženim izmjenama u informacijama o proizvodu.
English: On 30 October 2013, Sweden presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs.
Croatian: Dana 30. listopada 2013., Švedska je dostavila Agenciji obavijest o upućivanju u skladu sa člankom 35. Direktive 2011/82/EZ, u vezi s veterinarsko-medicinskim proizvodima koji sadrže tilozin koji se daje svinjama peroralno putem krmiva ili vode za piće.
English: referral for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs
Croatian: za veterinarsko medicinske proizvode koji sadrže tilozin koji se daje svinjama peroralno putem krmiva ili vode za piće
English: Opinion following an Article 35 referral for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs EMA/492247/2014
Croatian: Mišljenje nakon provedenog postupka upućivanja provedenog sukladno članku 35. za veterinarsko medicinske proizvode koji sadrže tilozin koji se daje svinjama peroralno putem krmiva ili vode za piće
English: Therefore, on 8 May 2014 the Committee adopted by consensus a positive opinion, recommending variations to the terms of the marketing authorisations for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs.
Croatian: izmjene u uvjetima odobrenja za stavljanje u promet veterinarsko-medicinskog proizvoda koji sadrže tilozin koji se daje svinjama peroralno putem krmiva ili vode za piće.
English: Package size βlister (PVC/PE/PVDC/alu)
Croatian: 75 mg 75 mg filmom obložena tableta filmom obložena tableta kroz usta kroz usta blister (PVC/PE/PVDC/alu) blister (PVC/PE/PVDC/alu) kalendar
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging
Croatian: Put primjene Unutarnje pakovanje
English: Further information on Semintra can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Više informacija o VMP-u Semintra nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The target SBP is between 120 and 140 mmHg.
Croatian: Ciljna je vrijednost SBP-a od 120 do 140 mmHg.
English: Semintra must not be given to pregnant or lactating cats.
Croatian: Semintra se ne smije davati mačkama tijekom graviditeta i laktacije.
English: This overview was last updated in March 2018.
Croatian: Pregled je posljednji put ažuriran u 03. 2018.
English: Other information about Semintra:
Croatian: Ostale informacije o VMP-u Semintra:
English: After 4 weeks the dose can be reduced in cats with systolic blood pressure (SBP) of less than 140 mmHg.
Croatian: Nakon četiri tjedna doza se može smanjiti u mačaka sa sistoličkim krvnim tlakom (SBP) nižim od 140 mmHg.
English: What is Semintra and what is it used for?
Croatian: Što je Semintra i za što se koristi?
English: Why is Semintra authorised in the EU?
Croatian: Zašto je Semintra odobren u EU-u?
English: If contact with the eyes occurs they should be rinsed with water.
Croatian: U slučaju kontakta VMP-a s očima, treba ih isprati vodom.
English: Two different strengths are available: 4 mg/ml to reduce proteinuria and 10 mg/ml to treat high blood pressure.
Croatian: Dostupne su dvije različite jačine: 4 mg/ml za smanjenje proteinurije i 10 mg/ml za liječenje visokog krvnog tlaka.
English: The European Medicines Agency decided that Semintra's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove odlučila je da koristi od VMP-a Semintra nadmašuju s njim povezane rizike te se može izdati odobrenje za njegovu primjenu u EU-u.
English: Semintra received a marketing authorisation valid throughout the EU, on 13 February 2013.
Croatian: Za VMP Semintra izdano je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 13. veljače 2013.
English: Pregnant women should take special care to avoid contact with the product.
Croatian: Trudnice moraju obratiti posebnu pozornost kako bi izbjegle kontakt s VMPom.
English: Semintra is a veterinary medicine used in cats to reduce proteinuria (protein in the urine) and to treat high blood pressure.
Croatian: Semintra je veterinarsko-medicinski proizvod koji se koristi u mačaka za smanjenje proteinurije (prisutnost proteina u mokraći) i liječenje visokog krvnog tlaka.
English: An overview of Semintra and why it is authorised in the EU
Croatian: Pregled VMP-a Semintra i zašto je odobren u EU-u
English: Semintra decreased protein in the urine within the first seven days after the start of treatment.
Croatian: VMP Semintra smanjio je protein u mokraći tijekom prvih sedam dana liječenja.
English: If Semintra is swallowed accidentally, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Croatian: U slučaju da se VMP Semintra slučajno proguta, potrebno je odmah potražiti liječnički savjet te mu pokazati uputu o VMP-u ili njegovu etiketu.
English: This allows blood pressure to drop with a resulting decrease in protein in the urine which may slow down progression of kidney disease.
Croatian: Time se omogućuje sniženje krvnog tlaka te ima za posljedicu manju količinu proteina u mokraći, što može usporiti progresiju bubrežne bolesti.
English: High blood pressure is also a long term problem of ageing cats which can occur with chronic kidney disease, hyperthyroidism (overactive thyroid gland) and other conditions.
Croatian: Visok krvni tlak također je dugoročan problem u starijih mačaka koji se može pojaviti kod kronične bubrežne bolesti, hipertireoze (prekomjerno aktivna štitnjača) i drugih stanja.
English: What are the risks associated with Semintra?
Croatian: Koji su rizici povezani s VMP-om Semintra?
English: People who are hypersensitive to telmisartan or other angiotensin II receptor antagonists should avoid contact with Semintra.
Croatian: Osobe koje su preosjetljive na telmisartan ili druge antagoniste receptora angiotenzina II trebaju izbjegavati kontakt s VMP-om Semintra.
English: Proteinuria can occur with chronic (long-term) kidney disease in cats, a common disease in elderly cats characterised by a progressive deterioration of kidney function over time.
Croatian: Proteinurija se može pojaviti kod kronične (dugotrajne) bubrežne bolesti, uobičajene bolesti u starijih mačaka, za koju je svojstveno progresivno pogoršanje funkcije bubrega.
English: The medicine is given once a day by mouth using the measuring syringe provided.
Croatian: VMP se daje jedanput na dan kroz usta s pomoću priložene mjerne štrcaljke.
English: Hands should be washed after giving the medicine.
Croatian: Nakon primjene VMP-a treba oprati ruke.
English: The most common side effects seen with Semintra are mild and short-lived vomiting and diarrhoea (which may affect up to 1 in 10 cats treated with the 10 mg/ml strength solution).
Croatian: Najčešće zabilježene nuspojave VMP-a Semintra jesu blago i kratkotrajno povraćanje i proljev (mogu se javiti u manje od 1 na 10 mačaka liječenih otopinom jačine 10 mg/ml).
English: In a second field study involving 294 cats with hypertension with average age 13 years, 194 cats given Semintra once a day for 28 days had a reduction of SBP of 25 mmHg at day 28 compared to 11 mmHg for 100 cats given placebo (a dummy treatment).
Croatian: U drugom terenskom ispitivanju koje je obuhvaćalo 294 mačke s hipertenzijom u prosječnoj dobi od 13 godina, u 194 mačke koje su jedanput na dan tijekom 28 dana primale VMP Semintra zabilježeno je sniženje SBP-a od 25 mmHg na 28. dan, u usporedbi s 11 mmHg u 100 mačaka koje su primale placebo (prividno liječenje).
English: To treat high blood pressure an initial dose of 2 mg telmisartan per kg bodyweight is used.
Croatian: Za liječenje visokog krvnog tlaka primjenjuje se početna doza od 2 mg telmisartana po kg tjelesne težine.
English: Angiotensin II is a powerful vasoconstrictor (a substance that constricts blood vessels).
Croatian: Angiotenzin II snažan je vazokonstriktor (tvar koja sužava krvne žile).