FrancophonIA/ELRC3.0 huggingface dataset:
English: Amprenavir ↓ expected (CYP3A4 induction by St. John's wort)
Croatian: Amprenavir očekuje se ↓ (indukcija CYP3A4 Gospinom travom)
English: For adults with mild hepatic impairment (Child-Pugh score: 5-6) the recommended dose is 700 mg fosamprenavir twice daily with 100 mg ritonavir once daily.
Croatian: Za odrasle s blagim oštećenjem jetre (Child-Pugh indeks: 5-6) preporučena doza je 700 mg fosamprenavira dva puta dnevno sa 100 mg ritonavira jedanput dnevno.
English: In subjects with moderate hepatic impairment (Child-Pugh score of 7-9), a reduced dose of fosamprenavir 450 mg twice daily with a reduced dosing frequency of ritonavir 100 mg once daily is predicted to deliver similar plasma amprenavir Cmax and AUC(0-12), but approximately 35 % lower plasma total amprenavir C12 values and approximately 88 % higher plasma unbound amprenavir C12 values than achieved in subjects with normal hepatic function receiving the standard fosamprenavir with ritonavir 700 mg / 100 mg twice daily regimen.
Croatian: Kod ispitanika s umjerenim oštećenjem jetre (Child-Pugh indeks 7-9) predviđa se da bi smanjena doza fosamprenavira od 450 mg 2 puta dnevno uz smanjenu učestalost doziranja ritonavirom od 100 mg jednom dnevno dala slične vrijednosti Cmax i AUC(0-12) amprenavira u plazmi, ali s oko 35 % nižom ukupnom vrijednosti C12 amprenavira u plazmi i oko 88% višim vrijednostima C12 za nevezani amprenavir od onih koje se postižu kod ispitanika s normalnom funkcijom jetre a koji primaju standardni režim doziranja fosamprenavirom i ritonavirom 700 mg/100 mg 2 puta dnevno.
English: For adult patients the fosamprenavir oral suspension should be taken without food and on an empty stomach.
Croatian: Odrasli bolesnici trebaju oralnu suspenziju fosamprenavira uzeti bez hrane, na prazan želudac.
English: If you have mild liver disease, the dose is 14 ml Telzir oral suspension (700 mg fosamprenavir) twice daily with 100 mg ritonavir only once daily.
Croatian: Ako bolujete od blage bolesti jetre doza je 14 ml Telzir oralne suspenzije (700 mg fosamprenavira) dva puta dnevno s 100 mg ritonavira samo jedan put dnevno.
English: Not studied.
Croatian: Nisu ispitivani.
English: Genotypic interpretation systems may be used to estimate the activity of amprenavir / ritonavir or fosamprenavir / ritonavir in subjects with PI-resistant isolates.
Croatian: Za procjenu aktivnosti amprenavira/ritonavira ili fosamprenavira/ritonavira kod ispitanika s izolatima otpornim na PI može se koristiti sustav za genotipsku interpretaciju.
English: Ergonovine: ↑ expected Ergotamine: ↑ expected Methylergonovine: ↑ expected
Croatian: Dihidroergotamin Ergotamin Ergonovin Metilergonovin
English: Baseline Characteristics ART/PI status, n (%) ART-naïve ART-experienced, PI-naïve PI-experienced Median duration of prior ART exposure, weeks NRTI PI Median plasma HIV-1 RNA log10 copies/mL
Croatian: Status liječenja antiretrovirusnom terapijom/inhibitorima proteaze, n (%) bolesnici koji ranije nisu primali antiretrovirusnu terapiju bolesnici koji su ranije primali antiretrovirusnu terapiju, ali ne i IP bolesnici koji su ranije primali IP Medijan trajanja izloženosti ranijoj antiretrovirusnoj terapiji, tjedni NRTI IP Medijan HIV-1 RNK log10 kopija/ml u plazmi
English: If a patient is already taking St John's wort, check amprenavir, ritonavir and HIV RNA and stop St John's wort.
Croatian: provjerite razine amprenavira, ritonavira i HIV RNK te prekinite uzimanje Gospine trave.
English: It is recommended that HIV-infected women must not breast-feed under any circumstances to avoid transmission of HIV.
Croatian: Kako bi se izbjegao prijenos HIV-a, preporučuje se da žene inficirane HIV-om nikada ne doje djecu.
English: Fosamprenavir with ritonavir therapy should be definitively stopped in case of severe rash or in case of rash of mild or moderate intensity associated with systemic or mucosal signs (see section 4.4).
Croatian: U slučaju teškog osipa ili u slučaju osipa blagog ili umjerenog intenziteta praćenog znacima zahvaćenosti sluznice ili sistemske zahvaćenosti terapiju fosamprenavirom s ritonavirom treba definitivno obustaviti (vidjeti dio 4.4).
English: NAME OF THE MEDICINAL PRODUCT Telzir 700 mg film-coated tablets
Croatian: Uputa o lijeku: Informacije za korisnika Telzir 700 mg filmom obložene tablete fosamprenavir
English: Geometric mean change
Croatian: Geometrijska srednja vrijednost promjene (%)
English: For adults with moderate hepatic impairment (Child-Pugh score: 7-9) the recommended dose is 450 mg fosamprenavir twice daily with 100 mg ritonavir once daily.
Croatian: Kod odraslih s umjerenim oštećenjem jetre (Child-Pugh indeks: 7-9) preporučena doza je 450 mg fosamprenavira 2 puta dnevno sa 100 mg ritonavira jedanput dnevno.
English: (Modest induction of CYP3A4 by FPV/RTV)
Croatian: (Blaga indukcija CYP3A4 lijekovima FPV/RTV)
English: Placental transfer of amprenavir has been shown to occur in humans.
Croatian: Pokazalo se da amprenavir prolazi kroz posteljicu u ljudi.
English: Amprenavir: AUC ↓ 82% Contraindicated (see section
Croatian: Amprenavir: AUC ↓ 82%
English: Microcrystalline cellulose Croscarmellose sodium Povidone K30
Croatian: celuloza, mikrokristalična karmelozanatrij, umrežena povidon K30 magnezijev stearat silicijev dioksid, koloidni, bezvodni
English: Stay in regular contact with your doctor
Croatian: →Obratite se svom liječniku.
English: All patients in this study had failed treatment with a previous protease inhibitor regimen (defined as plasma HIV-1 RNA that never went below 1,000 copies/ml after at least 12 consecutive weeks of therapy, or initial suppression of HIV-1 RNA which subsequently rebounded to ≥ 1,000 copies/ml).
Croatian: 12 uzastopnih tjedana terapije, ili kao početna supresija HIV1 RNK koja se nakon toga vratila na ≥1 000 kopija/ml).
English: Don't stop Telzir without advice Take Telzir for as long as your doctor recommends.
Croatian: Nemojte prestati uzimati Telzir bez savjeta
English: In the studies of PI-experienced adult patients, PRO30017 (amprenavir 600 mg / ritonavir 100 mg twice daily in sub-study A and B with 80 and 37 patients respectively), the following mutations emerged in patients with virological failure: L10F/I/V, V11I, I13V, K20R, V32I, L33F, E34Q, M36I, M46I/L, I47V, G48V, I50V, I54L/M/T/V, Q58E, D60E, I62V, A71V, V77I, V82A/I, I84V, I85V, L90M and I93L/M.
Croatian: A i B u koje je bilo uključeno 80 odnosno 37 bolesnika), kod bolesnika s virološkim neuspjehom pojavile su se sljedeće mutacije: L10F/I/V, V11I, I13V, K20R, V32I, L33F, E34Q, M36I, M46I/L, I47V, G48V, I50V, I54L/M/T/V, Q58E, D60E, I62V, A71V, V77I, V82A/I, I84V, I85V, L90M i I93L/M.
English: NAME OF THE MEDICINAL PRODUCT Telzir 50 mg/ml oral suspension
Croatian: Uputa o lijeku: Informacije za korisnika Telzir 50 mg/ml oralna suspenzija fosamprenavir
English: Each ml of oral suspension contains 50 mg fosamprenavir as fosamprenavir calcium (equivalent to approximately 43 mg amprenavir).
Croatian: Jedan ml oralne suspenzije sadrži 50 mg fosamprenavira u obliku fosamprenavirkalcija (što odgovara približno 43 mg amprenavira).
English: Each ml of suspension contains 50 mg of fosamprenavir as fosamprenavir calcium salt (equivalent to approximately 43 mg of amprenavir).
Croatian: Svaki ml suspenzije sadrži 50 mg fosamprenavira u obliku fosamprenavirkalcija (što odgovara približno 43 mg amprenavira).
English: Headache, dizziness, oral paraesthesia
Croatian: Poremećaji živčanog sustava Glavobolja, omaglica, oralne parestezije
English: Each ml of oral suspension contains 50 mg fosamprenavir as fosamprenavir calcium (equivalent to approximately 43 mg of amprenavir)
Croatian: Jedan ml oralne suspenzije sadrži 50 mg fosamprenavira u obliku fosamprenavirkalcija (što odgovara približno 43 mg amprenavira)
English: Vardenafil
Croatian: Terfenadin
English: If you get any side effects →Talk to your doctor or pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: Diarrhoea
Croatian: INFEKCIJE
English: Telzir with low doses of ritonavir is used in combination with other anti-retroviral medicines (‘combination therapy') to treat adults, adolescents and children aged over 6 years infected with HIV.
Croatian: ("kombinirana terapija") u liječenju odraslih, adolescenata i djece u dobi iznad 6 godina koji su inficirani HIV-om.
English: There have been reports of increased bleeding including spontaneous skin haematomas and haemarthroses in haemophiliac patients type A and B treated with protease inhibitors (PIs).
Croatian: A i B koji su liječeni inhibitorima proteaze (IP), uključujući spontane hematome na koži i hemartroze.
English: In subjects with severe hepatic impairment (Child-Pugh score of 10-13), a reduced dose of fosamprenavir 300 mg twice daily with a reduced dosing frequency of ritonavir 100 mg once daily delivered 19% lower plasma amprenavir Cmax, 23% lower AUC(0-12), and 38% lower C12 values, but similar unbound plasma amprenavir C12 values than achieved in subjects with normal hepatic function receiving the standard fosamprenavir with ritonavir 700 mg / 100 mg twice daily regimen.
Croatian: 300 mg 2 puta dnevno uz smanjenu učestalost doziranja ritonavirom od 100 mg jednom dnevno omogućavala je 19% niže vrijednosti Cmax za amprenavir u plazmi, 23% niže vrijednosti AUC(0-12) i 38 % niže vrijednosti C12, ali sa sličnim C12 vrijednostima za nevezani amprenavir u plazmi od onih koje se postižu kod ispitanika s normalnom funkcijom jetre, a koji primaju standardni dozni režim fosamprenavirom i ritonavirom 700 mg/100 mg 2 puta dnevno.
English: When antineoplastic agents agents:
Croatian: ANTINEOPLASTICI KOJI SE
English: Simeprevir
Croatian: Simeprevir Daklatazvir
English: Amprenavir metabolism is inhibited by ritonavir, via inhibition of CYP3A4, resulting in increased plasma concentrations of amprenavir.
Croatian: Ritonavir inhibira metabolizam amprenavira putem inhibicije CYP3A4,
English: Daclatasvir
Croatian: Midazolam
English: Children from 6 years of age and weighing less than 39 kg Use Telzir oral suspension.
Croatian: Djeca od 6. godine života sa tjelesnom težinom manjom od 39 kg
English: itraconazole are not recommended.
Croatian: uključujući rabdomiolizu.
English: 100 mg
Croatian: <25 kg
English: ORAL ANTICOAGULANTS
Croatian: ORALNI KONTRACEPTIVI
English: Non-inferiority was demonstrated between fosamprenavir co-administered with ritonavir and lopinavir / ritonavir based on the proportions of patients achieving plasma HIV-1 RNA levels < 400 copies/ml at 48 weeks (primary endpoint).
Croatian: Temeljem udjela bolesnika koji su postigli razine HIV-1 RNA u plazmi < 400 kopija/ml u 48. tjednu (primarni ishod), dokazana je neinferiornost fosamprenavira istodobno primijenjenog s ritonavirom prema lopinaviru/ritonaviru.
English: These may affect up to 1 in 10 people:
Croatian: Česte nuspojave mogu se javiti u manje od 1 od 10 osoba:
English: Children from 6 years of age and weighing at least 39 kg Children can take the adult tablet dose of one 700 mg Telzir tablet twice daily with ritonavir 100 mg twice daily if they can swallow the tablets whole.
Croatian: Ako tablete mogu progutati cijele, djeca mogu primati dozu tablete za odrasle od jedne tablete lijeka Telzir od 700 mg dva puta dnevno s ritonavirom od 100 mg dva puta dnevno.
English: ViiV Healthcare SAS Tél: + 33 (0)1 39 17 6969 Infomed@viivhealthcare.com
Croatian: ViiV Healthcare SAS Tél: + 33 (0)1 39 17 6969
English: Fosamprenavir is rapidly and almost completely hydrolysed to amprenavir and inorganic phosphate as it is absorbed through the gut epithelium, following oral administration.
Croatian: Nakon peroralne primjene fosamprenavir se apsorbira putem crijevnog epitela te brzo i gotovo u cijelosti hidrolizira na amprenavir i anorganske fosfate.
English: (Mixed CYP3A4 induction/inhibition)
Croatian: (Miješano indukcija/inhibicija CYP3A4)
English: The current (July 2006) ANRS AC-11 algorithm for fosamprenavir / ritonavir defines resistance as the presence of the mutations V32I+I47A/V, or I50V, or at least four mutations among: L10F/I/V, L33F, M36I, I54A/L/M/S/T/V,
Croatian: V32I+I47A/V, ili I50V ili barem četiri mutacije od: L10F/I/V, L33F, M36I, I54A/L/M/S/T/V, I62V,
English: If you notice any of these symptoms: Tell your doctor.
Croatian: Ako primijetite neki od tih simptoma:
English: (CYP3A4 induction by FPV/RTV)
Croatian: (indukcija CYP3A4 lijekovima FPV/RTV)
English: Bottle with 225 ml oral suspension A 10 ml graduated dosing syringe and adapter are also provided in the pack
Croatian: Boca s 225 ml oralne suspenzije
English: Each tablet contains 700 mg of fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg amprenavir).
Croatian: Jedna filmom obložena tableta sadrži 700 mg fosamprenavira u obliku fosamprenavirkalcija (što odgovara približno 600 mg amprenavira).
English: These may affect up to 1 in 100 people:
Croatian: Manje česte nuspojave mogu se javiti u manje od 1 na 100 osoba:
English: Important information about ingredients of Telzir oral suspension Telzir oral suspension contains propyl and methyl parahydroxybenzoate.
Croatian: Važne informacije o nekim sastojcima Telzir oralne suspenzije
English: Amiodarone: ↑ expected Bepridil: ↑ expected Quinidine: ↑ expected
Croatian: Dihidroergotamin: očekuje se ↑ Ergonovin: očekuje se ↑ Ergotamin: očekuje se ↑ Metilergonovin: očekuje se ↑
English: Calcium chloride dihydrate Artificial grape bubblegum flavour Natural peppermint flavour Purified water
Croatian: 6.1 Popis pomoćnih tvari hipromeloza sukraloza propilenglikol metilparahidroksibenzoat (E218) propilparahidroksibenzoat (E216) polisorbat 80 kalcijev klorid dihidrat umjetna aroma gume za žvakanje s okusom grožđa prirodna aroma peperminta pročišćena voda
English: The recommended dose is 14 ml Telzir oral suspension (700 mg fosamprenavir) twice daily with 100 mg ritonavir (as capsule or oral solution) twice daily.
Croatian: Preporučena doza je 14 ml Telzir oralne suspenzije (700 mg fosamprenavira) dva puta dnevno s
English: In vivo a) ART-naïve or PI-naïve patients
Croatian: In vivo a) Bolesnici koji ranije nisu primali antiretrovirusnu ili IP terapiju
English: Ketoconazole 200 mg once daily for four days
Croatian: 200 mg jednom dnevno tijekom 4 dana
English: No FPV/RTV drug interaction studies
Croatian: Otporni na FPV/RTV ≥ 4 mutacije od ocjene
English: Sucralose
Croatian: ADRENERGIČNIH
English: Fatigue
Croatian: Nuspojave
English: If you take too much Telzir
Croatian: Ako uzmete više lijeka Telzir nego što ste trebali
English: Zidovudine
Croatian: Natašte
English: Ranitidine 300 mg single dose
Croatian: 300 mg u jednoj dozi (Telzir 1400 mg u jednoj dozi)
English: Abacavir
Croatian: Maravirok
English: GlaxoSmithKline s.r.o.
Croatian: GlaxoSmithKline Slovakia s. r. o.
English: Solution
Croatian: PRIMJENU
English: Flecainide: ↑ expected Propafenone: ↑ expected
Croatian: Flekainid: očekuje se ↑ Propafenon: očekuje se ↑
English: If you notice any of these symptoms: →Tell your doctor.
Croatian: →Ako se nešto od navedenog odnosi na Vas, obavijestite svog liječnika.
English: Clinically validated phenotypic interpretation systems may be used in association with the genotypic data to estimate the activity of amprenavir / ritonavir or fosamprenavir / ritonavir in patients with PIresistant isolates.
Croatian: Za procjenu aktivnosti amprenavira/ritonavira ili fosamprenavira/ritonavira kod bolesnika s izolatima otpornim na IP mogu se koristiti klinički validirani sistemi za fenotipsku interpretaciju.
English: 225 ml oral suspension A 10 ml graduated dosing syringe and adapter are also provided in the pack
Croatian: U pakiranju se također nalaze graduirana odmjerna štrcaljka od 10 ml i nastavak
English: Flecainide: ↑ expected
Croatian: Flutikazon propionat
English: Elderly
Croatian: Ranitidin
English: Change from baseline in CD4 cells (cells/µl)
Croatian: Promjena od početnih vrijednosti CD4
English: If you have mild liver disease, the dose is one Telzir tablet (700 mg) twice daily with 100 mg ritonavir only once daily.
Croatian: Ako bolujete od blage bolesti jetre, doza je jedna tableta lijeka Telzir (700 mg) dva puta dnevno s
English: Rapamycin
Croatian: Rifampicin
English: b) PI-experienced patients
Croatian: b) bolesnici koji su ranije primali IP terapiju
English: Lamivudine
Croatian: Efavirenz
English: AAUCMB Mean Diff (97.5% CI)
Croatian: FPV/RTV BID naspram LPV/RTV BID AAUCMB Srednja vrijednost razlike (97,5% CI)
English: 33-38 kg Oral suspension
Croatian: 225 ml oralne suspenzije
English: When warfarin or other oral anticoagulants are coadministered with Telzir a reinforced monitoring of INR (International Normalised Ratio) is recommended (see section 4.5).
Croatian: International normalised ratio) u slučajevima kada se istodobno s lijekom Telzir primjenjuje varfarin ili drugi oralni antikoagulansi (vidjeti dio 4.5).
English: Harmire Road Barnard Castle Co. Durham DL12 8DT United Kingdom
Croatian: Durham DL12 8DT Ujedinjeno Kraljevstvo ili
English: 90 x 1 tablets (unit dose)
Croatian: 90x1 tableta obložene tablete
English: Powder for oral suspension bottle (glass)
Croatian: 10 mg/ml prašak za oralnu suspenziju
English: Solution for injection Intravenous use vial (glass)
Croatian: 0,8 mg/ml otopina za injekciju u venu
English: How much to take and when
Croatian: Koliko uzeti i kada
English: Additional information on special populations Elderly (≥ 65 years)
Croatian: Dodatne informacije o posebnim populacijama Starije osobe (≥65 godina)
English: Medical attention may be needed.
Croatian: Možda će biti potrebna medicinska pomoć.
English: However, this has not been established in the target population.
Croatian: To, međutim, nije ustanovljeno u ciljnoj populaciji.
English: Statistical non-inferiority was not achieved.
Croatian: Nije postignuta statistička neinferiornost.
English: The absolute bioavailability is 85%.
Croatian: Apsolutna bioraspoloživost je 85%.
English: Then take your next dose at the usual time.
Croatian: Nakon toga sljedeću dozu uzmite u uobičajeno vrijeme.
English: 112 tablets.
Croatian: 112 tableta.
English: Your doctor will tell you exactly how many tablets of Jalra to take.
Croatian: Liječnik će Vam reći točno koliko tableta Jalre trebate uzimati.
English: You may have to take this treatment over a long period of time.
Croatian: Ovu terapiju ćete možda morati uzimati kroz duže vremensko razdoblje.
English: If you take more Jalra than you should
Croatian: Ako uzmete više Jalre nego što ste trebali
English: Adjudicated cardiovascular events were balanced overall.
Croatian: Procijenjeni kardiovaskularni događaji bili su općenito uravnoteženi.
English: These changes are, however, not considered to be clinically relevant.
Croatian: Ove se promjene, međutim, ne smatraju klinički značajnim.
English: Do not stop taking Jalra unless your doctor tells you to.
Croatian: Nemojte prestati uzimati Jalru osim ako Vam to ne kaže liječnik.
English: If you need to see a doctor or go to the hospital, take the pack with you.
Croatian: Ako trebate otići liječniku ili u bolnicu, pakovanje ponesite sa sobom.
English: The maximum daily dose is 100 mg.
Croatian: Maksimalna dnevna doza je 100 mg.
English: A double dose should not be taken on the same day.
Croatian: U istom se danu ne smije uzeti dvostruka doza lijeka.
English: What Jalra is and what it is used for
Croatian: Što je Jalra i za što se koristi
English: If it is almost time for your next dose, skip the dose you missed.
Croatian: Ako je uskoro vrijeme za Vašu sljedeću dozu, preskočite dozu koju ste propustili uzeti.
English: If you have questions about how long to take this medicine, talk to your doctor.
Croatian: Ako imate pitanja o tome koliko dugo trebate uzimati ovaj lijek, obratite se svom liječniku.
English: Doses higher than 100 mg are not recommended.
Croatian: Ne preporučuju se doze veće od 100 mg.
English: Even though you are now starting a medicine for your diabetes, it is important that you continue to follow the diet and/or exercise which has been recommended for you.
Croatian: Iako sada počinjete uzimati lijek za svoju šećernu bolest, važno je da se nastavite pridržavati prehrane i/ili fizičke aktivnosti koja Vam je preporučena.
English: Date of first authorisation: 19 November 2008 Date of latest renewal: 28 November 2013
Croatian: Datum posljednje obnove odobrenja: 28. studenog 2013.
English: The expiry date refers to the last day of that month.
Croatian: “EXP“- Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.
English: • if you are allergic to vildagliptin or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na vildagliptin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: The amount of Jalra people have to take varies depending on their condition.
Croatian: Količina Jalre koju ljudi moraju uzimati ovisi o njihovu stanju.
English: Multipack: 336 (3 packs of 112) tablets.
Croatian: Višestruko pakiranje: 336 (3 pakiranja od 112) tableta.
English: Characteristics in specific groups of patients
Croatian: Svojstva u posebnim skupinama bolesnika
English: Rare cases of hepatic dysfunction (including hepatitis) have been reported.
Croatian: Rijetko su bili prijavljeni slučajevi poremećaja jetrene funkcije (uključujući hepatitis).
English: If you forget to take a dose of this medicine, take it as soon as you remember.
Croatian: Ako ste zaboravili uzeti dozu ovoga lijeka, uzmite ju čim se sjetite.
English: • Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Croatian: Vaše stanje kako bi utvrdio ima li liječenje željeni učinak.
English: EU/1/08/485/011 336 tablets (3 packs of 112)
Croatian: EU/1/08/485/011 336 tableta (3 pakiranja od 112)
English: In the event of an overdose, supportive management is recommended.
Croatian: U slučaju predoziranja preporučuje se suportivno liječenje.
English: Frequencies are defined as 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 se definira kao 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: What you need to know before you take Jalra
Croatian: Što morate znati prije nego počnete uzimati Jalru
English: However, there were imbalances in baseline cardiovascular risk favouring placebo and the number of events was low, precluding firm conclusions.
Croatian: Međutim, postojale su nejednakosti u početnom kardiovaskularnom riziku u korist placeba, a broj događaja bio je nizak, što onemogućuje čvrste zaključke.
English: The usual dose of Jalra is either:
Croatian: Uobičajena doza Jalre iznosi ili:
English: No data are available (see also section 5.1).
Croatian: Nema dostupnih podataka (vidjeti također dio 5.1).
English: However, the magnitude of change is not clinically significant, so that Jalra can be given with or without food.
Croatian: Međutim, stupanj promjene nije klinički značajan pa se Jalra može primjenjivati s hranom ili bez nje.
English: If you take too many Jalra tablets, or if someone else has taken your medicine, talk to your doctor straight away.
Croatian: Ako uzmete previše tableta Jalre, ili ako je netko drugi uzeo Vaš lijek, odmah se javite svom liječniku.
English: EU/1/08/485/001 7 tablets EU/1/08/485/002 14 tablets EU/1/08/485/003 28 tablets EU/1/08/485/004 30 tablets EU/1/08/485/005 56 tablets EU/1/08/485/006 60 tablets EU/1/08/485/007 90 tablets EU/1/08/485/008 112 tablets EU/1/08/485/009 180 tablets EU/1/08/485/010 336 tablets
Croatian: EU/1/08/485/001 7 tableta EU/1/08/485/002 14 tableta EU/1/08/485/003 28 tableta EU/1/08/485/004 30 tableta EU/1/08/485/005 56 tableta EU/1/08/485/006 60 tableta EU/1/08/485/007 90 tableta EU/1/08/485/008 112 tableta EU/1/08/485/009 180 tableta EU/1/08/485/010 336 tableta
English: The maximum change (increase or decrease) in the exposure to vildagliptin is ~30%, which is not considered to be clinically relevant.
Croatian: Maksimalna promjena (porast ili smanjenje) izloženosti vildagliptinu iznosi ~30%, što se ne smatra klinički značajnim.