FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in HALOCUR is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Croatian: Djelatna tvar u Halocuru je dozvoljena tvar kako je navedeno u tablici 1 Dodatka Uredbe Komisije (EU) No 37/2010:
English: In case of skin and eye contact wash the exposed area thoroughly with clean water.
Croatian: Kod slučajnog kontakta s kožom ili očima izloženo područje dobro isprati čistom vodom.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Croatian: Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijal dobiven primjenom tih veterinarsko-medicinskih proizvoda treba odlagati u skladu s lokalnim propisima.
English: For treatment of anorexic calves, the product should be administered in half a litre of an electrolyte solution.
Croatian: Za liječenje anoreksične teladi, proizvod treba primijeniti s pola litre elektrolitske otopine.
English: This medicinal product does not require any special storage conditions.
Croatian: Ovaj veterinarsko-medicinski proizvod ne zahtjeva posebne uvjete čuvanja.
English: The product is mainly excreted in the urine.
Croatian: Proizvod se uglavnom izlučuje u mokraći.
English: <Batch> <Lot> <BN> number.
Croatian: <Serija> <Lot> <BS> broj
English: Benzoic acid (E 210) Tartrazine (E 102) Lactic acid (E 270) Water, purified
Croatian: Benzoična kiselina (E 210) Tartrazin (E 102) Mliječna kiselina ( E 270) Voda, pročišćena
English: For oral use in calves after feeding.
Croatian: Za oralnu uporabu u teladi nakon hranjenja.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove ( http://www.ema.europa.eu/).
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.emea.europa.eu/.
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: Medicines should not be disposed of via wastewater.
Croatian: Proizvod ne treba odlagati u otpadne vode.
English: Shelf-life after first opening the container: 6 months.
Croatian: Rok valjanosti nakon otvaranja kontejnera: 6 mjeseci.
English: Repetitive contact with the product may lead to skin allergies.
Croatian: Učestalo korištenje proizvoda može uzrokovati alergijsku reakciju na koži.
English: The bioavailability of the drug in the calf, following single oral administration, is about 80 %.
Croatian: Biodostupnost lijeka u teleta, nakon jedne oralne primjene, je oko 80%.
English: Pharmacotherapeutic group: Quinazolinone derivate ATCvet code: QP51AX08
Croatian: Farmakoterapijska skupina: derivati kvinazolinona, ATCvet kod: QP51AX08 5.1 Farmakodinamička svojstva
English: Halofuginone base
Croatian: Halofuginon baza
English: Should clinical signs of overdosing occur the treatment must be stopped immediately and the animal fed unmedicated milk or milk replacer.
Croatian: Ako se klinički znakovi predoziranja jave liječenje mora biti odmah zaustavljeno i životinje se hrane bez lijekova u mlijeku ili mliječnoj zamjenici.
English: The plasmatic concentrations of halofuginone after repeated oral administrations are comparable to the pharmacokinetic pattern after single oral treatment.
Croatian: Plasmatska koncentracije halofuginona nakon ponovljenih oralnih primjena je usporediva s farmakokinetskim uzorkom nakon jedne oralne terapije.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE HDPE container (500 ml and 1000 ml presentations)
Croatian: PODACI NA VANJSKOM PAKOVANJU HDPE spremnik (500 ml i 1000 ml veličine)
English: To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration is necessary.
Croatian: Kako bi se osigurala točna doza potrebno je koristiti ili brizgaljku ili odgovarajući pribor za oralnu primjenu.
English: Special precautions for use in animals:
Croatian: Posebna upozorenja za upotrebu kod životinja:
English: Administer after colostrum feeding, or after milk or milk replacer feeding only, using either a syringe or any appropriate device for oral administration.
Croatian: Primijeniti nakon hranjenja kolostrumom, mlijekom ili mliječnim zamjenicama primijeniti samo koristeći brizgaljku ili odgovarajući pribor za oralnu primjenu.
English: The active substance, halofuginone, is an antiprotozoal agent of the quinazolinone derivatives group (nitrogenous polyheterocycles).
Croatian: Djelatna tvar, halofuginon je antiprotozoarna tvar, derivat skupine kvinazolinona (poliheterociklični dušik).
English: EU/2/99/013/001-002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/99/013/001-002
English: France
Croatian: Nizozemska
English: Avoid skin, eye or mucosal contact with the product.
Croatian: Izbjegavati kontakt proizvoda sa kožom, očima ili sluznicom.
English: Marketing authorisation holder: Intervet International B.V. Wim de Körverstraat 35
Croatian: Nositelj odobrenja za stavljanje u promet: Intervet International BV Wim de Körverstraat 35
English: - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: Reduction of diarrhoea due to diagnosed Cryptosporidium parvum.
Croatian: Smanjenje proljeva zbog dijagnoze Cryptosporidium parvum.
English: Administration should start within 24 hours after the onset of diarrhoea.
Croatian: Primjena bi trebala započeti unutar 24 sata nakon početka proljeva.
English: The veterinary medicinal product is a canary yellow oral solution.
Croatian: Veterinarsko-medicinski proizvod je oralna otopina jarko žute boje.
English: The time necessary to obtain the maximum concentration Tmax is 11 hours.
Croatian: Vrijeme potrebno za dobivanje maksimalne koncentracije
English: HALOCUR contains 0.5 mg/ml halofuginone base (as lactate salt).
Croatian: HALOCUR sadržava 0,5 mg/ml halofunginon baza (kao laktatna sol)
English: Manufacturer responsible for batch release: Intervet Productions S.A.
Croatian: Proizvođač odgovoran za puštanje serije u promet: Intervet Productions SA
English: The apparent volume of distribution is 10 l/kg.
Croatian: Prividni obujam raspodjele je 10 l/kg.
English: Halofuginone base (as lactate salt)
Croatian: Halofuginon baza (kao laktatna sol)
English: New born calves.
Croatian: Novorođena telad.
English: Halofuginone lactate (RU 38788) is a salt whose antiprotozoal properties and efficacy against Cryptosporidium parvum have been demonstrated both in in vitro conditions and in artificial and natural infections.
Croatian: Halofuginon laktat (RU 38788) je sol čija su se antiprotozoarna svojstva i djelotvornost protiv
English: The dosage is: 100 µg of halofuginone base / kg body weight (BW) / once a day for 7 consecutive days, i.e. 2 ml of HALOCUR / 10 kg BW / once a day for 7 consecutive days.
Croatian: Doza je: 100 µg halofuginon baze/kg tjelesne mase (TM)/ jednom dnevno / 7 uzastopnih dana, odnosno 2 ml HALOCUR / 10 kg TM/ jednom dnevno / 7 uzastopnih dana.
English: The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Croatian: Pomoćne tvari navedene u dijelu 6.1 SPC-a su dozvoljene tvari za koje je u tablici 1 Dodatka Uredbe Komisije ( EU)
English: Prevention of diarrhoea due to diagnosed Cryptosporidium parvum, in farms with history of cryptosporidiosis.
Croatian: Prevencija proljeva zbog dijagnoze Cryptosporidium parvum, na farmama s poviješću prethodne pojave kriptosporidioze.
English: STATEMENT OF ACTIVE SUBSTANCE
Croatian: SASTAV DJELATNIH TVARI
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated )
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojave) - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja)
English: Intervet Productions SA Rue de Lyons F-27460 Igoville France
Croatian: F-27460 Igoville Francuska
English: Oral solution Canary yellow homogenous clear solution.
Croatian: Jarko žuta homogena bistraotopina.
English: 35 kg < calves ≤ 45 kg: 8 ml of HALOCUR once a day during 7 consecutive days
Croatian: 35 kg <telad ≤ 45 kg: 8 ml HALOCUR jednom dnevno tijekom 7 uzastopnih dana 45 kg <telad <60 kg: 12 ml HALOCUR jednom dnevno tijekom 7 uzastopnih dana
English: It is mainly active on the free stages of the parasite (sporozoïte, merozoïte).
Croatian: Spoj ima kriptosporidiostatski učinak na Cryptosporidium parvum, te je uglavnom aktivan na slobodne stadijima parazita (sporozoït, merozoït).
English: Read package leaflet before use.
Croatian: Pročitati uputu prije primjene.
English: 500 ml bottle containing 490 ml of oral solution 1000 ml bottle containing 980 ml of oral solution
Croatian: VELIČINA PAKOVANJA 500 ml bočica koja sadrži 490 ml oralne otopine 1000 ml bočica koja sadrži 980 ml oralne otopine
English: 30 µg/kg 30 µg/kg 10 µg/kg 25 µg/kg
Croatian: 10 µg/kg 25 µg/kg jetra bubrezi mišići masno tkivo
English: For oral use in new born calves after feeding.
Croatian: Za oralnu primjenu u novorođene teladi nakon hranjenja: Pročitati uputu prije primjene.
English: Animal species MRLs
Croatian: Životinjsk a vrsta MRL Ciljna tkiva Ostale odredbe
English: High-density polyethylene portable bottle of 500 ml containing 490 ml of the oral solution.
Croatian: Polietilenska prijenosna boca visoke gustoće od 500 ml koja sadrži 490 ml oralne otopine.
English: Withdrawal period: Meat and offal: 13 days.
Croatian: KARENCIJA(E) Karencija: Meso i jestive iznutrice: 13 dana .
English: Target tissues
Croatian: Oralna otopina
English: Intervet International B.V. Wim de Körverstraat 35 NL-5831 AN Boxmeer The Netherlands
Croatian: NL-5831 AN Boxmeer
English: HALOCUR 0.5 mg/ml oral solution for calves
Croatian: HALOCUR 0,5 mg / ml oralna otopina za telad
English: High-density polyethylene portable bottle of 1000 ml containing 980 ml of the oral solution.
Croatian: Polietilenska prijenosna boca visoke gustoće od 1000 ml koja sadrži 980 ml oralne otopine.
English: Name and address of the manufacturer responsible for batch release
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije u promet Intervet Proizvodnja S.A.
English: PACKAGE LEAFLET: HALOCUR 0.5 mg/ml oral solution for calves
Croatian: Halocur 0,5 mg/ml oralne otopine za telad
English: TARGET SPECIES
Croatian: CILJNE VRSTE ŽIVOTINJA Novorođena telad
English: 45 kg < calves < 60 kg: 12 ml of HALOCUR once a day during 7 consecutive days For smaller or higher weights, a precise calculation should be performed (2 ml/10 kg BW).
Croatian: Za manju ili veću tjelesnu masu, treba izvršiti precizan izračun (2 ml/10 kg TM).
English: Immediate Packaging Content (concentratio n)
Croatian: Farmaceutski oblik Put primjene Unutarnje pakovanje Sastav (koncentracija)
English: Cats
Croatian: Konji
English: 1 blister (7 tablets)
Croatian: Blisteri (Alu/Alu) 7 tableta 1 blister (7 tableta)
English: Subcutaneous or intravenous use (dogs), subcutaneous use (cats)
Croatian: Potkožno ili u venu (psi), potkožno (mačke)
English: Subcutaneous use
Croatian: Mačke Potkožno
English: Oral suspension Pigs
Croatian: Svinje Kroz usta
English: Contact our press officers Monika Benstetter or Martin Harvey
Croatian: Obratite se našim djelatnicima za medije Monika Benstetter ili Martin Harvey
English: • Patients who have any questions should ask their doctor or pharmacist.
Croatian: • Bolesnici koji imaju bilo kakvih pitanja trebaju se obratiti svojem liječniku ili ljekarniku.
English: 2 More information can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Referrals/Tredaptive, Pelzont and Trevaclyn.
Croatian: 2 Više informacija dostupno je na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Human medicines/Referrals/Tredaptive, Pelzont and Trevaclyn.
English: In the EU, acipimox-containing medicines are currently marketed in Austria, Belgium, Denmark, Hungary, Italy, Luxembourg, the Netherlands and the United Kingdom.
Croatian: Na području EU-a lijekovi koji sadrže acipimoksom trenutno su dostupni na tržištima u Austriji, Belgiji, Danskoj, Mađarskoj, Italiji, Luksemburgu, Nizozemskoj i Ujedinjenoj Kraljevini.
English: This was endorsed by the CMDh.
Croatian: Ovo je potvrđeno od strane CMDh-a.
English: In higher doses, it reduces the levels of fat in the blood.
Croatian: U većim dozama, snižava razine masti u krvi.
English: 1 The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Croatian: 1 CMDh, tijelo koje predstavlja države članice EU-a, odgovorno je za osiguravanje usklađenih sigurnosnih standarda za lijekove odobrene putem nacionalnih postupaka diljem EU-a.
English: A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Croatian: Pregled ovih podataka prvi je puta provelo Povjerenstvo za ocjenu rizika na području farmakovigilancije (PRAC).
English: The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Croatian: Preporuke PRAC-a dostavljene su Koordinacijskoj grupi za postupak međusobnog priznavanja i decentralizirane postupke za humane lijekove (CMDh), koja je usvojila konačno mišljenje.
English: • Most patients taking acipimox are already using it in this way, but the product information is being updated to clarify the recommended use.
Croatian: • Većina bolesnika koji uzimaju acipimoks već ga uzima na ovaj način, no informacije o proizvodu se ažuriraju da bi se pojasnila preporučena primjena.
English: CMDh endorses PRAC recommendation
Croatian: CMDh potvrdio preporuku PRAC-a
English: • Acipimox is a medicine used to treat disorders related to high levels of fat in the blood.
Croatian: • Acipimoks je lijek koji se koristi za liječenje poremećaja povezanih s visokim razinama masti u krvi.
English: These recommendations were originally made by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) at its meeting of 5-8 November 2013.
Croatian: Ove je preporuke prvotno iznijelo Povjerenstvo za ocjenu rizika na području farmakovingilacije (PRAC) pri Europskoj agenciji za lijekove na sastanku održanom od 5. do 8. studenog 2013.
English: Medicines containing nicotinic acid or related substances have been authorised in the EU via national procedures since the mid-1950s.
Croatian: Lijekovi koji sadrže nikotinsku kiselinu ili povezane djelatne tvari odobreni su na razini EU-a putem nacionalnih postupaka od sredine 1950.-ih.
English: 20 February 2014 EMA/108603/2014
Croatian: 20. veljače 2014.
English: The review of nicotinic acid and its related substances acipimox and xantinol nicotinate was initiated on 27 February 2013 at the request of the Danish Health and Medicines Authority, under Article 31 of Directive 2001/83/EC.
Croatian: Pregled nikotinske kiseline i povezanih tvari acipimoksa i ksantinol nikotinata započet je dana 27. veljače 2013. na zahtjev danske Agencije za zdravstvo i lijekove, sukladno članku 31. Direktive 2001/83/EZ.
English: Nicotinic acid is a naturally occurring substance used in low doses as a vitamin (known as niacin or vitamin B3).
Croatian: Nikotinska kiselina prirodno se pojavljuje u tvarima koje se koriste u malim dozama poput vitamina (poznati pod nazivom niacin ili vitamin B3).
English: As the CMDh position was adopted by majority vote, it was sent to the European Commission, which endorsed it and issued an EU-wide legally binding decision on 20 February 2014.
Croatian: S obzirom da je mišljenje CMDh-a usvojeno većinom glasova, isto je dostavljeno Europskoj komisiji, koja ga je potvrdila i usvojila kao pravno obvezujuću odluku na razini EU-a 20. veljače 2014.
English: Nicotinic acid was also authorised in combination with laropiprant.
Croatian: Nikotinska kiselina također je odobrena u kombinaciji s laropiprantom.
English: The CMDh endorsed the PRAC recommendations by majority at its meeting of 16-18 December 2013 and its position was sent to the European Commission which endorsed it and issued an EU-wide legally binding decision on 20 February 2014.
Croatian: CMDh je većinski potvrdio preporuke PRAC-a na svojem sastanku održanom od 16. do 18. prosinca 2013., te je svoje mišljenje dostavio Europskoj komisiji koja ga je potvrdila i usvojila kao pravno obvezujuću odluku na razini EU-a dana 20. veljače 2014.
English: As a result, the European Medicines Agency recommended the suspension of medicines containing the combination of nicotinic acid and laropiprant across the EU2.
Croatian: Slijedom navedenog, Europska agencija za lijekove preporučila je suspenziju lijekova koji sadrže kombinaciju nikotinske kiseline i laropipranta na razini EU-a2.
English: Acipimox is a substance closely related to nicotinic acid that has been available since 1984 as Olbetam and other trade names for the treatment of lipid disorders.
Croatian: Acipimoks je tvar koja je usko povezana s nikotinskom kiselinom koja je dostupna od 1984. pod nazivom Olbetam i drugim trgovačkim nazivima za liječenje poremećaja lipida.
English: • Based on the available data, the indications for acipimox should be restricted to alternative or adjunct treatment in patients who have not responded adequately to other treatments such as statin or fibrate treatment.
Croatian: • Na temelju dostupnih podataka, indikacije za acipimoks trebaju se ograničiti na alternativnu ili dodatnu terapiju u bolesnika koji nisu primjereno odgovorili na druge terapije poput liječenja statinom ili fibratom.
English: Acipimox-containing medicines should be used when changes in lifestyle, including diet and exercise, and treatment with other medicines are not adequate.
Croatian: Lijekovi koji sadrže acipimoks trebaju se koristiti samo u slučajevima kada promjene u životnom stilu, uključujući prehranu i vježbanje, te terapija drugim lijekovima nisu primjerene.
English: The review of acipimox was based on the limited available efficacy and safety data on acipimox as well as data from the scientific literature relating to the structurally related compound nicotinic acid.
Croatian: Pregled acipimoksa temeljio se na ograničenim dostupnim podacima o djelotvornosti i sigurnosti kao i na podacima iz znanstvene literature u vezi sa strukturno povezanim spojem nikotinske kiseline.
English: Flushing, rash and gastrointestinal effects (nausea, dyspepsia, diarrhoea and upper abdominal pain) are the most frequently reported adverse effects for acipimox and are listed in the acipimox product information, together with pruritus, erythema, urticaria and angioedema.
Croatian: Crvenilo, osip i gastrointestinalno djelovanje (mučnina, dispesija, proljev i bol u gornjem abdomenu) najčešće su prijavljene nuspojave lijeka acipimoks i navedene su u informacijama o proizvodu, zajedno s pruritusom, eritemom, urtikarijom i angiedemom.
English: In July 2013 it was established that nicotinic acid and the related substance xantinol nicotinate were not currently marketed in the EU to treat lipid disorders (xantinol nicotinate is authorised in some EU countries for oral use as a vasodilator, a medicine that widens the blood vessels used to treat blood circulation problems) and the review was therefore restricted to acipimox only.
Croatian: U srpnju 2013. utvrđeno je da nikotinska kiseline i povezana tvar ksantinol nikotinat nisu trenutno odobreni za stavljanje u promet u EU-u za liječenje poremećaja lipida (ksantinol nikotinat odobren je samo u pojedinim državama EU-a za peroralnu primjenu kao vazodilatator, lijek koji širi krvne žile, a koristi se za liječenje problema s optokom krvi), te je pregled s toga ograničen samo na acipimoks.
English: In addition, the PRAC consulted an ad-hoc expert group of European experts on the use of acipimox.
Croatian: Nadalje, PRAC se o primjeni acipimoksa savjetovao s ad-hoc stručnom grupom europskih stručnjaka.
English: On 18 December 2013, the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh)1 confirmed by majority that medicines containing acipimox should have their marketing authorisations amended to ensure that they are used across the European Union only as an additional or alternative treatment in type IIb and type IV hyperlipoproteinaemia.
Croatian: Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh)1 većinski je potvrdila da odobrenje za stavljanje u promet lijekova koji sadrže acipimoks treba izmijeniti kako bi se osiguralo da se ovi lijekovi diljem Europske unije koriste samo kao dodatna ili alternativna terapija za hiperlipoproteinemiju tipa IIb i tipa IV.
English: The study showed that adding this combination to treatment with statins (another class of medicines used to treat lipid disorders) did not lead to additional benefits in reducing the risk of major vascular events such as heart attack and stroke, but did result in a higher frequency of non-fatal but serious side effects.
Croatian: Ispitivanjem je dokazano da dodavanje ove kombinacije terapiji statinima (drugoj klasi lijekova koji se koriste za liječenje poremećaja lipida) nije donijelo dodatne koristi u snižavanju rizika od većih vaskularnih događaja poput srčanog udara i moždanog udara, no nije rezultiralo većom učestalošću ozbiljnih nuspojava bez smrtnih posljedica.
English: After looking at the available data on acipimox, including evidence from the literature, spontaneous reports of adverse effects and advice from a group of experts in the treatment of lipid disorders, as well as data from HPS2-THRIVE, the PRAC concluded that acipimox continues to have a role as an additional or alternative treatment to reduce triglycerides in those forms of hyperlipoproteinaemia that involve high triglyceride levels (with or without increased cholesterol), in patients in whom lifestyle changes and use of other medicines such as fibrates and statins are not adequate.
Croatian: Nakon pregleda dostupnih podataka o acipimoksu, uključujući i dokaze iz literature, spontane prijave nuspojava i savjete grupe stručnjaka na području liječenja poremećaja lipida, kao i podataka prikupljenih ispitivanjem HPS2-THRIVE, PRAC je zaključio da acipimoks i dalje ima ulogu kao dodatna ili alternativna terapija za snižavanje triglicerida u onih oblika hiperlipoproteinemije koji uključuju visoke razine triglicerida (s ili bez povišenog kolesterola) u bolesnika u kojih promjene životnog stila i primjena drugih lijekova, poput fibrata i statina, nisu primjerene.
English: Laropiprant has no effect on cholesterol but it reduces flushing, which is a known side effect of nicotinic acid.
Croatian: Laropiprant nema utjecaja na kolesterol, no smanjuje crvenilo, koje je poznato kao nuspojava nikotinske kiseline.
English: • Having reviewed the available safety data, including data on nicotinic acid obtained from HPS2THRIVE, the PRAC considered the safety profile of acipimox to be well characterised.
Croatian: • Nakon pregleda dostupnih podataka o sigurnosti primjene, uključujući i podatke o nikotinskoj kiselini prikupljenih ispitivanjem HPS2-THRIVE, PRAC je zaključio da je sigurnosni profil acipimoksa dobro opisan.