FrancophonIA/ELRC3.0 huggingface dataset:
English: Place the oral syringe tip between the dog's cheek and gum and press the plunger until the ring-stop causes the plunger to stop.
Croatian: Štrcaljku za oralnu primjenu postavite između obraza i desni psa pa potiskujte klip dok ga prsten ne zaustavi.
English: The Sileo oral syringe delivers the product in small increments (0.25 ml).
Croatian: Štrcaljka za oralnu primjenu Sileo proizvod primjenjuje u malim dozama (0,25 ml).
English: Dexmedetomidine as an alpha-2 adrenoceptor agonist alters the levels of NA, serotonin (5-HT) and dopamine (DA) in the hippocampus and frontal cortex, indicating that such compounds affect also the regions of the brain involved in creating and maintaining complex anxieties.
Croatian: Deksmedetomidin kao alfa-2 adrenergični antagonist mijenja razine noradrenalina, serotonina (5-HT) i dopamina (DA) u hipokampusu i čeonom korteksu, ukazujući da takvi spojevi utječu i na područja mozga koja sudjeluju u stvaranju i održavanju kompleksnih anksioznosti.
English: The effects of dexmedetomidine can be eliminated using a specific antidote (reversal medicine).
Croatian: Učinci deksmedetomidina mogu se ukloniti primjenom određenog antidota (protulijeka).
English: Shelf life after first opening the immediate packaging (removal of the cap): 4 weeks.
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja (skidanje čepa): 4 tjedna.
English: In case of eye or oromucosal contact, rinse abundantly with fresh water.
Croatian: U slučaju kontakta s kožom ili sluznicom, obilno operite svježom vodom.
English: In case of skin contact wash the exposed skin immediately after exposure with large amounts of water and remove contaminated clothes.
Croatian: Ako dođe u kontakt s kožom, odmah je nakon izlaganja obilno operite vodom i skinite kontaminiranu odjeću.
English: Instructions for dosing the gel:
Croatian: Upute za doziranje gela:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Oral syringe
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: Box 4366 Nydalen N-0402 Oslo
Croatian: Orion Pharma AS Animal Health P.O. Box 4366 Nydalen N-0402 Oslo
English: DOSE SELECTION AND DOSING:
Croatian: ODABIR DOZE I DOZIRANJE:
English: The use of other central nervous system depressants is expected to potentiate the effects of dexmedetomidine and therefore an appropriate dose adjustment should be made by the veterinary surgeon.
Croatian: Prilikom primjene drugih depresiva središnjeg živčanog sustava očekuje se potenciranje učinaka deksmedetomidina, stoga veterinar mora prilagoditi dozu.
English: Avenida Río de Janeiro, 60-66, planta 13 08016 Barcelona (España) Tel: + 34 93 5955000
Croatian: Avenida Río de Janeiro, 60-66, planta 13 08016 Barcelona
English: The dosing table provides the number of dots to be administered corresponding to the dog's bodyweight.
Croatian: U tablici za doziranje prikazan je broj točaka koje je potrebno primijeniti u skladu s masom psa.
English: The Sileo oral syringe is capable of delivering the product in 0.25 ml increments.
Croatian: Štrcaljka za oralnu primjenu može isporučiti proizvod u dozama od 0,25 ml.
English: New oral syringe set up before first dosing:
Croatian: POSTAVLJANJE NOVE ŠTRCALJKE ZA ORALNU PRIMJENU PRIJE PRVOG DOZIRANJA:
English: The effects of dexmedetomidine can be eliminated using a specific antidote, atipamezole (alpha-2 adrenoceptor antagonist).
Croatian: Učinci deksmedetomidina mogu se ukloniti primjenom posebnog antidota, atipamezola (alfa-2 adrenergičnog antagonista).
English: Push yellow seal and pull open
Croatian: Pritisnite žutu zaštitu i povucite da biste otvorili.
English: Lock the ring-stop by turning it away from you.
Croatian: Prsten zaključajte okretanjem od sebe.
English: Common reactions: - paleness of the mucous membranes at the application site - tiredness (sedation) - vomiting - uncontrolled urination.
Croatian: Česte nuspojave: - bljedilo mukoznih membrana na mjestu primjene, - umor (sedacija), - povraćanje, - nekontrolirano mokrenje.
English: MOVE RING Move the ring-stop to the opposite end of the plunger.
Croatian: 4. POMICANJE PRSTENA Prsten pomaknite na suprotan kraj klipa.
English: OTHER INFORMATION INSTRUCTIONS FOR DOSING THE GEL:
Croatian: 15. OSTALE INFORMACIJE UPUTE ZA DOZIRANJE GELA:
English: MARKETING AUTHORISATION NUMBER(S) EU/2/15/181/001 (1 x 3 ml oral syringe)
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/15/181/001 (štrcaljka za oralnu primjenu, 1 x 3 ml)
English: In case of accidental ingestion or prolonged mucosal contact, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: Ako se slučajno proguta ili ako je dulje vrijeme u kontaktu sa sluznicom, odmah zatražite liječničku pomoć i pokažite mu uputu o VMP ili naljepnicu.
English: Keep the package out of sight and reach of children at all times.
Croatian: Pakovanje uvijek držite izvan dosega djece.
English: Higher than recommended doses of Sileo gel may also induce a number of other alpha-2 adrenoceptor mediated effects, which include mydriasis, depression of motor and secretory functions of the gastrointestinal tract, temporary AV-blocks, diuresis and hyperglycaemia.
Croatian: Doze gela Sileo veće od preporučenih mogu potaknuti druge alfa-2 adrenergične učinke, što uključuje midrijazu, depresiju motornih funkcija i funkcija izlučivanja probavnog sustava, privremene AV blokove, diurezu i hiperglikemiju.
English: Ružová dolina 6, 821 08 Bratislava, SR Tel: +421 250 221 215
Croatian: 821 08 Bratislava, SR Tel: +421 250 221 215
English: If the oromucosal gel is swallowed it will become less effective.
Croatian: Ako se gel za usnu sluznicu proguta, bit će manje učinkovit.
English: Hydroxypropylcellulose Sodium laurilsulfate Brilliant blue (E133) Tartrazine (E102)
Croatian: 6.1 Popis pomoćnih tvari voda, pročišćena propilen-glikol hidroksipropilceluloza natrijev lauril-sulfat briljant plavo (E133) tartrazin (E102) natrij-hidroksid (za prilagodbu pH) kloridna kiselina (za prilagodbu pH)
English: Text on the seals: Push
Croatian: Tekst na zaštiti: Pritisni
English: INDICATION(S) For the alleviation of acute anxiety and fear associated with noise in dogs.
Croatian: INDIKACIJE Za ublažavanje akutne anksioznosti i straha u pasa vezanih uz buku.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Sileo is a translucent, green oromucosal gel containing 0.1 mg/ml dexmedetomidine hydrochloride (active substance), equivalent to 0.09 mg/ml dexmedetomidine.
Croatian: Sileo je prozirni, zeleni gel za usnu sluznicu koji sadrži 0,1 mg/ml deksmedetomidin hidroklorida (djelatna tvar), ekvivalentno 0,09 mg/ml deksmedetomidina.
English: Dexmedetomidine, the active ingredient of Sileo, is an alpha-2 adrenoceptor agonist.
Croatian: Deksmedetomidin, djelatna tvar gela Sileo, agonist je alfa-2 adrenoceptora.
English: Hold the plunger with your right hand and lock the ring-stop by turning it away from you.
Croatian: 5. ZAKLJUČAVANJE Klip držite desnom rukom i zaključajte prsten okretanjem od sebe.
English: Instead, it must be placed onto the mucosa between the dog's cheek and gum of the dog.
Croatian: Mora se primijeniti na sluznicu između obraza i desni psa.
English: Dexmedetomidine hydrochloride 0.1 mg (equivalent to 0.09 mg dexmedetomidine).
Croatian: Djelatna tvar: deksmedetomidin hidroklorid 0,1 mg (ekvivalentno 0,09 mg deksmedetomidina).
English: Translucent, green gel.
Croatian: Prozirni, zeleni gel.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Dexmedetomidine hydrochloride 0.1 mg/ml
Croatian: KOLIČINA DJELATNE(IH) TVARI Deksmedetomidin hidroklorid 0,1 mg/ml
English: Active substance:
Croatian: Česte nuspojave:
English: Deutschland Ecuphar GmbH, Brandteichstraße 20, 17489 Greifswald, Deutschland
Croatian: 17489 Greifswald Deutschland
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES 1 ml: Dexmedetomidine hydrochloride 0.1 mg
Croatian: I DRUGIH TVARI 1 ml: deksmedetomidin hidroklorid 0,1 mg
English: Viale Francesco Restelli, 3/7 20124 Milano (Italia) Tel: + 39 0282950604
Croatian: Viale Francesco Restelli, 3/7 20124 Milano
English: Dexmedetomidine is eliminated by biotransformation mainly in the liver, with a half-life in dogs ranging from 0.5 to 3 hours after oromucosal administration.
Croatian: Poluvijek je u pasa u rasponu od 0,5 do 3 sata nakon oromukozne primjene.
English: Feeding and giving the dog treats within 15 minutes after administration of the gel should therefore be avoided.
Croatian: Stoga je potrebno 15 minuta nakon primjene gela izbjegavati hranjenje psa i davanje poslastica.
English: N-methylation, N-glucuronidation and oxidation in the imidazole ring have also been observed.
Croatian: U imidazolnom prstenu uočeni su i N-metilacija, N-glukuronidacija i oksidacija.
English: Reduced heart rate may be seen after administration of higher than recommended doses of Sileo gel.
Croatian: Nakon primjene doza gela Sileo većih od preporučenih, moguće je usporavanje pulsa.
English: Due to peripheral vasoconstriction, transient paleness of mucous membranes at the application site may be observed.
Croatian: Moguće je uočiti prolazno bljedilo mukoznih membrana na mjestu primjene zbog perifernih vazokonstrikcija.
English: Sileo is administered onto the oral mucosa between the dog's cheek and gum.
Croatian: Sileo se primjenjuje na sluznicu usta između obraza i desni psa.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/15/181/001-005 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10/06/2015
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/15/181/001-005
English: PACKAGE SIZE 1 x 3 ml oral syringe
Croatian: OBLIK Gel za usnu sluznicu VELIČINA PAKOVANJA Štrcaljka za oralnu primjenu, 1 x 3 ml
English: WEAR GLOVES
Croatian: 1. NOŠENJE RUKAVICA
English: Wear impermeable disposable gloves when handling the veterinary medicinal product.
Croatian: Prilikom rukovanja veterinarsko-medicinskim proizvodom nosite jednokratne nepropusne rukavice.
English: No measurable concentrations were found after gastro-intestinal gavage of dexmedetomidine to dogs.
Croatian: Nakon prisilne primjene deksmedetomidina sondom u pasa nisu pronađene mjerljive koncentracije.
English: Special precautions for use in animals:
Croatian: Posebne mjere opreza prilikom primjene:
English: If the oromucosal gel is swallowed it will become ineffective.
Croatian: Ako se gel za usnu sluznicu proguta, neće biti učinkovit.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Sileo 0.1 mg/ml oromucosal gel dexmedetomidine HCl
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Sileo 0,1 mg/ml gel za usnu sluznicu deksmedetomidin HCl
English: BACK TO PACKAGE
Croatian: 11. VRAĆANJE U KUTIJU
English: Your dog should not be given Sileo if it: - has severe liver, kidney or heart disease.
Croatian: Psu nemojte davati Sileo u sljedećim situacijama: - ako boluje od teške bolesti jetre, bubrega ili srca, - ako je preosjetljiv na djelatnu tvar ili na bilo koju pomoćnu tvar, - ako je pospan od prethodno primijenjenog lijeka.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oromucosal use.
Croatian: NAČIN I PUT(EVI) PRIMJENE
English: The use of other central nervous system depressants is expected to potentiate the effects of dexmedetomidine and therefore an appropriate dose adjustment should be made.
Croatian: 4.8 Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija Prilikom primjene drugih depresiva središnjeg živčanog sustava očekuje se potenciranje učinaka deksmedetomidina, stoga je potrebno prilagoditi dozu.
English: PHARMACEUTICAL FORM Oromucosal gel.
Croatian: OBLIK Gel za usnu sluznicu.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Sileo 0.1 mg/ml oromucosal gel for dogs dexmedetomidine hydrochloride
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Sileo 0,1 mg/ml gel za usnu sluznicu za pse deksmedetomidin hidroklorid
English: WITHDRAWAL PERIOD
Croatian: 6. OTKLJUČAVANJE
English: Pull
Croatian: NUSPOJAVE
English: Save the cap for replacement.
Croatian: Čep sačuvajte da biste ga ponovno upotrijebili.
English: B. PACKAGE LEAFLET
Croatian: 2. DRŽANJE KLIPA
English: (for 5 x 1, 10 x 1 and 20 x 1 multipacks only)
Croatian: Višestruko pakovanje nije namijenjeno izravnoj distribuciji vlasnicima životinja. (samo za 5 x 1, 10 x 1 i 20 x 1 višestruka pakovanja)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Sileo 0.1 mg/ml oromucosal gel for dogs
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Sileo 0,1 mg/ml, gel za usnu sluznicu za pse
English: Interaction with other medicinal products and other forms of interaction: Inform your veterinary surgeon if your dog is using other medicines.
Croatian: Obavijestite svog veterinara ako pas dobiva druge lijekove.
English: PHARMACEUTICAL FORM Oromucosal gel
Croatian: Štrcaljka za oralnu primjenu
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Croatian: PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA Informacije o bacanju lijeka kada više nije potreban zatražite od veterinara ili liječnika.
English: BATCH NUMBER
Croatian: Broj točaka
English: PACKAGE LEAFLET FOR: Sileo 0.1 mg/ml oromucosal gel for dogs
Croatian: UPUTA O VMP ZA Sileo 0,1 mg/ml, gel za usnu sluznicu za pse
English: HOLD PLUNGER
Croatian: Povuci
English: 1139 Budapest, Pap Károly u. 4-6 Tel: +36 1 886 3015
Croatian: 1139 Budapest, Pap Károly u.
English: Therefore, the Committee considered that these effects need to be closely monitored and managed.
Croatian: Stoga je Odbor zaključio da te učinke treba pomno nadzirati i analizirati.
English: This summary was last updated in 01-2016.
Croatian: Sažetak je posljednji put ažuriran u siječnju 2016.
English: The patient's disease should be confirmed by genetic testing whenever possible.
Croatian: Kad god je to moguće, bolest treba potvrditi genetskim testiranjem.
English: Treatment should begin at a dose of 5 mg once per day, and if well tolerated may be steadily increased to a maximum dose of 60 mg per day.
Croatian: Terapiju treba započeti s dozom od 5 mg jednom dnevno te ako se dobro podnosi može se polako povećati do maksimalne doze od 60 mg dnevno.
English: Lojuxta lomitapide
Croatian: Lojuxta lomitapid
English: Lojuxta has been authorised under ‘exceptional circumstances'.
Croatian: Lijek Lojuxta je odobren u „iznimnim okolnostima”.
English: It will also contain educational materials to be given to patients, including a brochure and an alert card.
Croatian: Također će sadržavati edukativne materijale koji se daju bolesnicima, uključujući brošuru i karticu upozorenja.
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Croatian: Objašnjava kako je Agencija ocijenila lijek da bi preporučila njegovo odobrenje u EU-u te uvjete za njegovo korištenje.
English: It is available as capsules (5, 10, 20, 30, 40 and 60 mg) to be taken by mouth on an empty stomach, at least two hours after the evening meal.
Croatian: Lijek je dostupan u obliku kapsula (5, 10 i 20, 30, 40 i 60 mg) koje se uzimaju natašte kroz usta barem dva sata nakon večernjeg obroka.
English: It must also not be used by patients with moderately or severely reduced liver function or with unexplained, abnormal liver test results, or by patients with significant or long-term bowel problems.
Croatian: Također ga ne smiju koristiti bolesnici s umjerenom ili jako oslabljenom funkcijom jetre ili s neobjašnjenim, neuobičajenim rezultatima jetrenih testova ili bolesnici sa značajnim ili dugotrajnim problemima s crijevima.
English: The most common side effects are problems with the gut, which may affect as many as 9 out of 10 people: diarrhoea and nausea (feeling sick) were each seen in around 7 out of 10 people, dyspepsia (heartburn) and vomiting were each seen in more than 3 out of 10 people, while pain, discomfort and bloating of the abdomen (belly), constipation and flatulence were each seen in at least 2 out of 10 people.
Croatian: Najčešće nuspojave su problemi sa želucem koji mogu zahvatiti 9 od 10 osoba: proljev i mučnina bili su uočeni kod otprilike 7 od 10 osoba, dispepsija (žgaravica) i povraćanje bili su uočeni kod više od 3 od 10 osoba, dok su bol, nelagoda u trbuhu i nadutost abdomena (trbuh), konstipacija (zatvor) i flatulencija uočeni kod barem 2 od 10 osoba.
English: However, the CHMP noted that the long-term benefit for the heart and circulatory system still needed to be confirmed.
Croatian: Međutim, CHMP je napomenuo da dugotrajne dobrobiti za srce i krvotok još treba potvrditi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lojuxta on 31 July 2013.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Lojuxta na snazi u Europskoj uniji od 31. srpnja 2013.
English: On average, the patients' LDL cholesterol levels were reduced by 40%.
Croatian: U prosjeku su razine LDL kolesterola u krvi bolesnika bile smanjene za 40 %.
English: What measures are being taken to ensure the safe and effective use of Lojuxta?
Croatian: Koje se mjere poduzimaju kako bi se osiguralo sigurno i učinkovito korištenje lijeka Lojuxta?
English: The study will also provide data on pregnancies in women taking the medicine, and on healthcare professionals' compliance with the recommendations to screen and monitor patients before and during treatment.
Croatian: Ispitivanje će također pružiti podatke o trudnoćama u žena koje uzimaju lijek te o pridržavanju zdravstvenih djelatnika preporuka o procjeni i nadzoru bolesnika prije i tijekom terapije.
English: This is because it has not been possible to obtain complete information about Lojuxta to date due to the rarity of the disease.
Croatian: Razlog za navedeno je nemogućnost dobivanja potpunih informacija o lijeku Lojuxta zbog rijetkosti bolesti.
English: This is a summary of the European public assessment report (EPAR) for Lojuxta.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku za lijek Lojuxta.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Lojuxta'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 odlučio je da koristi od lijeka Lojuxta nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: Patients taking certain other medicines may also need to take a reduced dose or take Lojuxta and their other medication at different times.
Croatian: Bolesnici koji uzimaju određene druge lijekove možda također trebaju uzimati smanjenu dozu lijeka ili uzimati lijek Lojuxta i druge lijekove koje piju u različito vrijeme.
English: Lojuxta must not be used in women who are pregnant.
Croatian: Lijek Lojuxta ne smije se koristiti u trudnica.
English: Lojuxta must not be used together with over 40 mg per day of simvastatin (another medicine used to lower blood cholesterol levels) or with certain other medicines that affect the way lomitapide is broken down in the body.
Croatian: Lojuxta se ne smije koristiti skupa s dozom simvastatina većom od 40 mg po danu (drugi lijek koji se koristi za snižavanje razina kolesterola u krvi) ili s određenim drugim lijekovima koji utječu na način razgradnje lomitapida u organizmu.
English: What is Lojuxta and what is it used for?
Croatian: Što je Lojuxta i za što se koristi?
English: Patients should avoid drinking grapefruit juice while taking Lojuxta.
Croatian: Bolesnici trebaju izbjegavati piti sok od grejpa tijekom primjene lijeka Lojuxta.
English: Treatment should be started and monitored by a doctor experienced in treating conditions involving high levels of fats in the blood.
Croatian: Terapiju (liječenje) treba započeti i nadzirati liječnik iskusan u liječenju stanja koja uključuju visoke razine masnoća u krvi.
English: It is not intended to provide practical advice on how to use Lojuxta.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Lojuxta.
English: Patients on kidney dialysis may need to take a reduced dose.
Croatian: Bolesnici koji su na dijalizi bubrega možda trebaju uzimati smanjenu dozu.
English: By blocking this protein, Lojuxta decreases the level of fats released into the blood, thereby helping to reduce the level of cholesterol in hypercholesterolaemia.
Croatian: Blokadom ovog proteina, Lojuxta smanjuje razinu masnoća koje se otpuštaju u krv i tako pomaže smanjenju razine kolesterola kod hiperkolesterolemije.
English: Lojuxta is a medicine that contains the active substance lomitapide.
Croatian: Lojuxta je lijek koji sadrži djelatnu tvar lomitapid.
English: Lojuxta was not compared with any other treatment.
Croatian: Lijek Lojuxta nije uspoređivan niti s jednom drugom terapijom.
English: A risk management plan has been developed to ensure that Lojuxta is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Lojuxta.
English: The main measure of effectiveness was the change in the patients' blood levels of ‘low density lipoprotein' (LDL) cholesterol, commonly known as ‘bad cholesterol', after 26 weeks of treatment.
Croatian: Glavna mjera učinkovitosti bila je promjena u razinama „lipoproteina niske gustoće” (LDL) u krvi bolesnika koji se još nazivaju i „loši kolesterol” nakon 26 tjedana liječenja.
English: The Committee also noted that Lojuxta had side effects in the gut in most patients, which caused some patients to stop treatment, and that it led to increased liver enzyme levels whose long-term consequences are not known.
Croatian: Odbor je također zaključio da lijek Lojuxta uzrokuje nuspojave u želucu većine bolesnika, što je ponukalo neke bolesnike na to da prekinu terapiju, a to je kod njih uzrokovalo porast razine jetrenih enzima čije dugoročne posljedice nisu poznate.
English: Other information about Lojuxta
Croatian: Druge informacije o lijeku Lojuxta
English: The benefits of Lojuxta in reducing blood cholesterol were assessed in a main study involving 29 patients with homozygous familial hypercholesterolaemia.
Croatian: Dobrobiti lijeka Lojuxta u smanjenju razine kolesterola bile su analizirane u glavnom ispitivanju koje je uključivalo 29 bolesnika s homozigotnom obiteljskom hiperkolesterolemijom.
English: It is used to treat adult patients with homozygous familial hypercholesterolaemia, an inherited disease causing high blood levels of cholesterol (a type of fat).
Croatian: Koristi se za liječenje bolesnika s homozigotnom obiteljskom hiperkolesterolemijom, nasljednom bolesti koja uzrokuje visoke razine kolesterola (vrsta masnoće).
English: In addition, the company that markets Lojuxta will provide educational materials to all doctors expected to prescribe Lojuxta, containing information on how to select suitable patients as well as key safety information, including side effects, interactions with other medicines and use in women who could potentially have children.
Croatian: Osim toga, tvrtka koja stavlja na tržište lijek Lojuxta osigurati će edukativne materijale svim liječnicima za koje se očekuje da će propisivati lijek Lojuxta, a koji će sadržavati informacije o tome kako odabrati prikladne bolesnike kao i ključne sigurnosne informacije uključujući i nuspojave, interakcije s drugim lijekovima i primjenu kod žena koje bi mogle zatrudnjeti.
English: It is used together with a low fat diet and other medicines to reduce the level of fats in the blood.
Croatian: Koristi se zajedno s niskomasnom dijetom i drugim lijekovima za smanjenje razine masnoća u krvi.
English: Since Lojuxta has been approved under exceptional circumstances, the company that markets the medicine is carrying out a long-term study in patients taking Lojuxta to provide further data on its safety and effectiveness, including its side effects on the liver, stomach, gut, and cardiovascular system.
Croatian: Budući da je lijek Lojuxta odobren u iznimnim okolnostima, farmaceutska tvrtka koja lijek Lojuxta stavlja na tržište provodi dugotrajno ispitivanje na bolesnicima koji uzimaju lijek Lojuxta kako bi osigurala dodatne podatke o njegovoj sigurnosti i učinkovitosti, uključujući nuspojave lijeka na jetru, trbuh, želudac i kardiovaskularni sustav.