FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/2/13/155/001 (1 tablet, 270 mg/4.5 mg) EU/2/13/155/002 (1 x 3 tablets, 270 mg/4.5 mg) EU/2/13/155/003 (1 x 6 tablets, 270 mg/4.5 mg) EU/2/13/155/004 (1 tablet, 425 mg/7.1 mg) EU/2/13/155/005 (1 x 3 tablets, 425 mg/7.1 mg) EU/2/13/155/006 (1 x 6 tablets, 425 mg/7.1 mg)
Croatian: EU/2/13/155/001 (1 tableta, 270 mg/4,5 mg) EU/2/13/155/002 (1 x 3 tablete, 270 mg/4,5 mg) EU/2/13/155/003 (1x 6 tableta, 270 mg/4,5 mg) EU/2/13/155/004 (1 tableta, 425 mg/7,1 mg) EU/2/13/155/005 (1 x 3 tablete, 425 mg/7,1 mg) EU/2/13/155/006 (1x 6 tableta, 425 mg/7,1 mg)
English: Trifexis 1040 mg/17.4 mg spinosad 1040 mg/milbemycin oxime 17.4 mg
Croatian: Trifexis 1040 mg/17,4 mg spinosad 1040 mg/milbemicin oksim 17,4 mg
English: It is recommended that lungworm prevention should be continued until at least 1 month after the last exposure to slugs and snails, but not for more than 6 consecutive months using Trifexis in any one year.
Croatian: Preporučuje se nastavak prevencije plućnog oblića do najmanje 1 mjesec nakon posljednjeg izlaganja puževima i golaćima, ali se Trifexis ne smije primjenjivati više od 6 mjeseci zaredom, u jednoj godini.
English: Post-marketing reports following the concomitant use of spinosad with ivermectin indicate that dogs have experienced trembling/twitching, salivation/drooling, seizures, ataxia, mydriasis, blindness and disorientation.
Croatian: Izvještaji nakon stavljanja VMP u promet nakon istovremene primjene spinosada i ivermektina pokazuju da je u pasa uočeno drhtanje/trzanje, salivacija/slinjenje, epileptički napadaji, ataksija, midrijaza, sljepilo i gubitak orijentacije.
English: Trifexis 1040 mg/17.4 mg tablets:
Croatian: Trifexis 1040 mg/17,4 mg tablete:
English: For the treatment and prevention of flea (Ctenocephalides felis) infestations in dogs where one or more of the following indications are required concurrently: - prevention of heartworm disease (L3, L4 Dirofilaria immitis), - prevention of angiostrongylosis by reducing the level of infection with immature adult (L5)
Croatian: Za liječenje i prevenciju infestacija buhama (Ctenocephalides felis) kod pasa, kada se pojavi jedna ili više istovremenih indikacija: - za prevenciju bolesti srčanog crva (L3, L4, Dirofilaria immitis).
English: 4333 and 2 dimples
Croatian: 4333 i 2 rupice
English: Post-marketing reports: following the concomitant use of spinosad with ivermectin indicate that dogs have experienced trembling/twitching, salivation/drooling, seizures, ataxia, mydriasis, blindness and disorientation.
Croatian: Izvještaji nakon stavljanja VMP u promet, nakon istovremene primjene spinosada i ivermektina pokazuju da je u pasa uočeno drhtanje/trzanje, salivacija/slinjenje, epileptički napadaji, ataksija, midrijaza, sljepilo i gubitak orijentacije.
English: As the safety of this veterinary medicinal product in male dogs used for breeding has not been determined, it should only be used according to the benefit-risk assessment by the responsible veterinarian
Croatian: Budući da neškodljivost ovog veterinarsko-medicinskog proizvoda nije potvrđena u pasa za rasplod, isti se smije primijeniti samo nakon procjene odnosa koristi/rizika od strane odgovornog veterinara.
English: EU/2/13/155/001 (1 tablet, 270 mg/4.5 mg) EU/2/13/155/002 (1 x 3 tablets, 270 mg/4.5 mg) EU/2/13/155/003 (1 x 6 tablets, 270 mg/4.5 mg) EU/2/13/155/004 (1 tablet, 425 mg/7.1 mg) EU/2/13/155/005 (1 x 3 tablets, 425 mg/7.1 mg) EU/2/13/155/006 (1 x 6 tablets, 425 mg/7.1 mg) EU/2/13/155/007 (1 tablet, 665 mg/11.1 mg) EU/2/13/155/008 (1 x 3 tablets, 665 mg/11.1 mg) EU/2/13/155/009 (1 x 6 tablets, 665 mg/11.1 mg) EU/2/13/155/010 (1 tablet, 1040 mg/17.4 mg) EU/2/13/155/011 (1 x 3 tablets, 1040 mg/17.4 mg) EU/2/13/155/012 (1 x 6 tablets, 1040 mg/17.4 mg) EU/2/13/155/013 (1 tablet, 1620 mg/27.0 mg) EU/2/13/155/014 (1 x 3 tablets, 1620 mg/27.0 mg) EU/2/13/155/015 (1 x 6 tablets, 1620 mg/27.0 mg)
Croatian: EU/2/13/155/001 (1 tableta, 270 mg/4,5 mg) EU/2/13/155/002 (1 x 3 tablete, 270 mg/4,5 mg) EU/2/13/155/003 (1x 6 tableta, 270 mg/4,5 mg) EU/2/13/155/004 (1 tableta, 425 mg/7,1 mg) EU/2/13/155/005 (1 x 3 tablete, 425 mg/7,1 mg) EU/2/13/155/006 (1x 6 tableta, 425 mg/7,1 mg) EU/2/13/155/007 (1 tableta, 665 mg/11,1 mg) EU/2/13/155/008 (1 x 3 tablete, 665 mg/11,1 mg) EU/2/13/155/009 (1x 6 tableta, 665 mg/11,1 mg) EU/2/13/155/010 (1 tableta, 1040 mg/17,4 mg) EU/2/13/155/011 (1 x 3 tablete, 1040 mg/17,4 mg) EU/2/13/155/012 (1x 6 tableta, 1040 mg/17,4 mg) EU/2/13/155/013 (1 tableta, 1620 mg/27,0 mg) EU/2/13/155/014 (1 x 3 tablete, 1620 mg/27,0 mg) EU/2/13/155/015 (1x 6 tableta, 1620 mg/27,0 mg)
English: Angiostrongylus vasorum, - treatment of gastrointestinal nematode infections caused by hookworm (L4, immature adult (L5)
Croatian: - za prevenciju angiostrongiloze, smanjenjem infestacije s nezrelim odraslim (L5) Angiostrongylus vasorum, - za liječenje gastrointestinalne infestacije nematodima, uzrokovane: kukastim crvom (L4, nezrele odrasle jedinke (L5) i odrasle jedinke Ancylostoma caninum), glistama pasa (nezrele odrasle jedinke
English: Trifexis 425 mg/7.1 mg spinosad 425 mg/milbemycin oxime 7.1 mg
Croatian: Trifexis 425 mg/7,1 mg spinosad 425 mg/milbemicin oksim 7,1 mg
English: PACKAGE SIZE 1 chewable tablet 3 chewable tablets 6 chewable tablets
Croatian: VELIČINA PAKOVANJA 1 tableta za žvakanje
English: Trifexis 425 mg/7.1 mg tablets:
Croatian: Trifexis 425 mg/7,1 mg tablete:
English: EU/2/13/155/007 (1 tablet, 665 mg/11.1 mg) EU/2/13/155/008 (1 x 3 tablets, 665 mg/11.1 mg) EU/2/13/155/009 (1 x 6 tablets, 665 mg/11.1 mg) EU/2/13/155/010 (1 tablet, 1040 mg/17.4 mg) EU/2/13/155/011 (1 x 3 tablets, 1040 mg/17.4 mg) EU/2/13/155/012 (1 x 6 tablets, 1040 mg/17.4 mg) EU/2/13/155/013 (1 tablet, 1620 mg/27.0 mg) EU/2/13/155/014 (1 x 3 tablets, 1620 mg/27.0 mg) EU/2/13/155/015 (1 x 6 tablets, 1620 mg/27.0 mg)
Croatian: EU/2/13/155/007 (1 tableta, 665 mg/11,1 mg) EU/2/13/155/008 (1 x 3 tablete, 665 mg/11,1 mg) EU/2/13/155/009 (1x 6 tableta, 665 mg/11,1 mg) EU/2/13/155/010 (1 tableta, 1040 mg/17,4 mg) EU/2/13/155/011 (1 x 3 tablete, 1040 mg/17,4 mg) EU/2/13/155/012 (1x 6 tableta, 1040 mg/17,4 mg) EU/2/13/155/013 (1 tableta, 1620 mg/27,0 mg) EU/2/13/155/014 (1 x 3 tablete, 1620 mg/27,0 mg) EU/2/13/155/015 (1x 6 tableta, 1620 mg/27,0 mg)
English: PACKAGE LEAFLET FOR: Trifexis 270 mg/4.5 mg chewable tablets for dogs Trifexis 425 mg/7.1 mg chewable tablets for dogs Trifexis 665 mg/11.1 mg chewable tablets for dogs Trifexis 1040 mg/17.4 mg chewable tablets for dogs Trifexis 1620 mg/27 mg chewable tablets for dogs
Croatian: UPUTA O VMP ZA: Trifexis 270 mg/4,5 mg tablete za žvakanje za pse Trifexis 425 mg/7,1 mg tablete za žvakanje za pse Trifexis 665 mg/11,1 mg tablete za žvakanje za pse Trifexis 1040 mg/17,4 mg tablete za žvakanje za pse Trifexis 1620 mg/27 mg tablete za žvakanje za pse
English: Trifexis 270 mg/4.5 mg spinosad 270 mg/milbemycin oxime 4.5 mg
Croatian: Trifexis 270 mg/4,5 mg spinosad 270 mg/milbemicin oksim 4,5 mg
English: Spinosad and milbemycin oxime have been shown to be substrates for P-glycoprotein (P-gp) and therefore could interact with other P-gp substrates (for example, digoxin, doxorubicin) or other macrocyclic lactones.
Croatian: Pokazalo se da su spinosad i milbemicin oksim supstrati P-glikoproteina (Pgp) i stoga mogu uzajamno djelovati s drugim
English: Trifexis 270 mg/4.5 mg tablets:
Croatian: Trifexis 270 mg/4,5 mg tablete:
English: 4336 and 5 dimples
Croatian: 4336 i 5 rupica
English: 4346 and 3 dimples
Croatian: 4346 i 3 rupice
English: It is recommended that heartworm prevention treatment should be continued at regular monthly intervals until at least 1 month after the last exposure to mosquitoes, but not for more than 6 consecutive months using Trifexis in any one year.
Croatian: Preporučuje se nastavak prevencije bolesti srčanog crva u redovnim mjesečnim intervalima sve do 1 mjesec nakon posljednjeg izlaganja komarcima, ali Trifexis se ne smije davati dulje od 6 mjeseci uzastopno, unutar jedne godine.
English: In pregnant and lactating dogs (bitches), the safety of this veterinary medicinal product has not been sufficiently established.
Croatian: Neškodljivost ovog veterinarsko-medicinskog proizvoda kod gravidnih i kuja koje doje nije dovoljno utvrđena.
English: Trifexis 270 mg/4.5 mg chewable tablets for dogs (3.9 - 6.0 kg) Trifexis 425 mg/7.1 mg chewable tablets for dogs (6.1 - 9.4 kg) Trifexis 665 mg/11.1 mg chewable tablets for dogs (9.5 - 14.7 kg) Trifexis 1040 mg/17.4 mg chewable tablets for dogs (14.8 - 23.1 kg) Trifexis 1620 mg/27 mg chewable tablets for dogs (23.2 - 36.0 kg)
Croatian: Trifexis 270 mg/4,5 mg tablete za žvakanje za pse (3,9 - 6,0 kg) Trifexis 425 mg/7,1 mg tablete za žvakanje za pse (6,1 - 9,4 kg) Trifexis 665 mg/11,1 mg tablete za žvakanje za pse (9,5 - 14,7 kg) Trifexis 1040 mg/17,4 mg tablete za žvakanje za pse (14,8 - 23,1 kg) Trifexis 1620 mg/27 mg tablete za žvakanje za pse (23,2 - 36,0 kg)
English: Trifexis 270 mg/4.5 mg for dogs (3.9 - 6.0 kg) Trifexis 425 mg/7.1 mg for dogs (6.1 - 9.4 kg) Trifexis 665 mg/11.1 mg for dogs (9.5 - 14.7 kg) Trifexis 1040 mg/17.4 mg for dogs (14.8 - 23.1 kg) Trifexis 1620 mg/27 mg for dogs (23.2 - 36.0 kg)
Croatian: Trifexis 270 mg/4,5 mg za pse (3,9 - 6,0 kg) Trifexis 425 mg/7,1 mg za pse (6,1 - 9,4 kg) Trifexis 665 mg/11,1 mg za pse (9,5 - 14,7 kg) Trifexis 1040 mg/17,4 mg za pse (14,8 - 23,1 kg) Trifexis 1620 mg/27 mg za pse (23,2 - 36,0 kg)
English: Heartworm prevention treatment should be continued monthly, with the last administration being given one month after the dog has left the region, but not for more than 6 consecutive months using Trifexis in any one year.
Croatian: Prevencija bolesti srčanog crva mora se nastaviti na mjesečnoj bazi, a posljednja primjena treba biti mjesec dana nakon što je pas napustio takvo područje, ali Trifexis se ne smije davati dulje od 6 mjeseci uzastopno unutar jedne godine.
English: In another study, after repeated monthly oral administration of 70 mg spinosad and 1.18 mg milbemycin oxime/kg bodyweight to fed adult dogs for twelve consecutive months, steady state for systemic exposure (AUC) was reached in month 3.
Croatian: U drugom ispitivanju, nakon ponovljenog mjesečnog oralnog davanja 70 mg spinosada i 1,18 mg milbemicin oksima/kg tjelesne težine uhranjenim odraslim psima tijekom dvanaest mjeseci, postignuto je stabilno stanje sustavne izloženosti (AUC) u 3. mjesecu za.
English: In another study, after repeated monthly oral administration of 70 mg spinosad and 1.18 mg milbemycin oxime/kg bodyweight to fed juvenile dogs for twelve consecutive months, steady state for systemic exposure (AUC) was reached by month 7.
Croatian: U drugom ispitivanju, nakon ponovljenog mjesečnog oralnog davanja 70 mg spinosada i 1,18 mg milbemicin oksima/kg tjelesne težine uhranjenim mladim psima tijekom dvanaest mjeseci zaredom, postignuto je stabilno stanje sustavne izloženosti (AUC) do 7. mjeseca.
English: In another study, after repeated oral administration of 70 mg spinosad and 1.18 mg milbemycin oxime/kg bodyweight to fed juvenile dogs for twelve consecutive months, steady state for systemic exposure (AUC) was reached by month 7.
Croatian: U drugom ispitivanju, nakon ponovljenog peroralnog davanja 70 mg spinosada i 1,18 mg milbemicin oksima/kg tjelesne težine, uhranjenim mladim psima tijekom dvanaest mjeseci zaredom, postignuto je stabilno stanje sustavne izloženosti (AUC) do 7. mjeseca.
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
Croatian: 14. RIJEČI „ČUVATI IZVAN POGLEDA
English: Date of first authorisation: 15 July 2016
Croatian: Datum prvog odobrenja: 15. srpnja 2016.
English: What to do if you forget to take a tablet.
Croatian: Što trebate učiniti ako ste zaboravili uzeti tabletu.
English: (See sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations studied.)
Croatian: (Vidjeti dijelove 4.2, 4.4, 4.5 i 5.1 za dostupne podatke o ispitivanim kombinacijama).
English: - You can take the tablet at any time of the day.
Croatian: - Tabletu možete uzeti u bilo koje doba dana.
English: Qtern is taken orally once daily.
Croatian: Qtern se uzima peroralno jedanput na dan.
English: Some symptoms need immediate medical attention:
Croatian: Neki simptomi zahtijevaju hitnu liječničku pomoć:
English: The safety and efficacy of this medicinal product in children and adolescents aged 0 to < 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost ovog lijeka kod djece i adolescenata u dobi od 0 do < 18 godina nisu još ustanovljene.
English: Taking this medicine - Swallow the tablet whole with half a glass of water.
Croatian: Uzimanje lijeka - Tabletu progutajte cijelu, s pola čaše vode.
English: Fournier's gangrene has to be treated immediately.
Croatian: Fournierovu gangrenu potrebno je odmah liječiti.
English: What Qtern is and what it is used for
Croatian: Što je Qtern i za što se koristi
English: Tablet is to be swallowed whole.
Croatian: Tabletu treba progutati cijelu.
English: - Do not take a double dose of Qtern to make up for a forgotten dose.
Croatian: - Nemojte uzeti dvostruku dozu lijeka Qtern da biste nadoknadili zaboravljenu dozu.
English: EU/1/16/1108/001 14 film-coated tablets EU/1/16/1108/002 28 film-coated tablets EU/1/16/1108/003 98 film-coated tablets EU/1/16/1108/004 30 film-coated tablets
Croatian: EU/1/16/1108/001 14 filmom obloženih tableta EU/1/16/1108/002 28 filmom obloženih tableta EU/1/16/1108/003 98 filmom obloženih tableta EU/1/16/1108/004 30 filmom obloženih tableta
English: There is no restriction based solely on age.
Croatian: Nema ograničenja isključivo na temelju dobi.
English: Qtern is not recommended during pregnancy and your doctor will ask you to stop taking this medicine if you become pregnant.
Croatian: Qtern se ne preporučuje tijekom trudnoće i Vaš će liječnik zatražiti da prestanete uzimati ovaj lijek ako zatrudnite.
English: The increased/decreased risk was not statistically significant in any of the organ systems.
Croatian: Niti povećan niti smanjen rizik nije ni u jednom organskom sustavu bio statistički značajan.
English: Study CV181168
Croatian: Ispitivanje CV181168
English: For more information, see section “Other medicines and Qtern” below.
Croatian: Za više informacija vidjeti dio „Drugi lijekovi i Qtern” u nastavku.
English: It may be taken at any time of day with or without food.
Croatian: Može se uzeti u bilo koje doba dana, s hranom ili bez nje.
English: Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs above.
Croatian: Liječnik će Vam reći kako liječiti niske razine šećera u krvi i što učiniti ako se pojavi neki od gore navedenih znakova.
English: Your doctor may ask you to stop taking Qtern until you recover to prevent dehydration.
Croatian: Vaš liječnik može zatražiti da prestanete uzimati Qtern dok se ne oporavite kako biste spriječili dehidraciju.
English: Your doctor will advise you of the signs and symptoms of heart failure.
Croatian: Liječnik će Vas upozoriti na znakove i simptome zatajenja srca.
English: Your doctor may decide to temporarily or permanently stop your treatment with Qtern.
Croatian: Vaš liječnik može odlučiti privremeno ili trajno prekinuti Vaše liječenje lijekom Qtern.
English: PA/Alu/PVC-Alu blister
Croatian: PA/Al/PVC-Al blister.
English: See section 4.4
Croatian: Vidjeti dio 4.4
English: What Qtern looks like and contents of the pack
Croatian: Kako Qtern izgleda i sadržaj pakiranja
English: Talk to your doctor about the best way to control your blood sugar while you are pregnant.
Croatian: Razgovarajte sa svojim liječnikom o najboljem načinu kontrole razine šećera u krvi tijekom trudnoće.
English: If you take more Qtern tablets than you should, talk to a doctor or go to a hospital straight away.
Croatian: Ako uzmete više Qtern tableta nego što ste trebali, odmah se obratite liječniku ili otiđite u bolnicu.
English: There are insufficient data to draw conclusions regarding exposure in patients > 70 years old.
Croatian: Nema dovoljno podataka da bi se donijeli zaključci o izloženosti kod bolesnika starijih od 70 godina.
English: Qtern is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients.
Croatian: Primjena lijeka Qtern ne preporučuje se kod djece i adolescenata mlađih od 18 godina jer lijek nije ispitivan kod tih bolesnika.
English: This is a rare but serious and potentially life-threatening event that requires urgent surgical intervention and antibiotic treatment.
Croatian: To je rijedak, no ozbiljan i potencijalno po život opasan događaj koji zahtijeva hitnu kiruršku intervenciju i liječenje antibioticima.
English: What Qtern is and what it is used for What you need to know before you take Qtern How to take Qtern
Croatian: Što je Qtern i za što se koristi Što morate znati prije nego počnete uzimati Qtern Kako uzimati Qtern
English: Therefore, Qtern should not be used during pregnancy.
Croatian: Stoga, Qtern se ne smije upotrebljavati tijekom trudnoće.
English: Especially tell your doctor: - if you are taking a medicine used to increase the amount of water you pass out of the body (diuretic).
Croatian: Posebno je važno da obavijestite svog liječnika: - ako uzimate lijek koji se koristi za povećavanje količinu vode koju izlučujete iz tijela (diuretik).
English: Necrotising fasciitis of the perineum (Fournier's gangrene)
Croatian: Nekrotizirajući fasciitis perineuma (Fournierova gangrena)
English: Additional analysis did not indicate a differential effect among NYHA classes.
Croatian: Dodatna analiza nije ukazala na razliku u učinku kod različitih NYHA stupnjeva.
English: If you have type 2 diabetes, your pancreas does not make enough insulin or your body is not able to use the insulin it produces properly.
Croatian: Ako imate šećernu bolesti tipa 2, gušterača Vam ne proizvodi dovoljno inzulina ili tijelo ne može pravilno iskoristiti inzulin koji proizvodi.
English: This is an antibiotic used to treat infections such as tuberculosis.
Croatian: To je antibiotik koji se koristi za liječenje infekcija poput tuberkuloze. - ketokonazol.
English: This may be used to treat inflammation in different body parts and organs.
Croatian: On se može koristiti za liječenje upala u različitim dijelovima tijela i organima.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union references dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Like for all diabetic patients it is important to check your feet regularly and adhere to any other advice regarding foot care given by your health care professional.
Croatian: Kao i za sve bolesnike sa šećernom bolešću, važno je redovito provjeravati svoja stopala i pridržavati se svih drugih savjeta o njezi stopala koje vam daje Vaš zdravstveni radnik.
English: UNIQUE IDENTIFIER 2D BARCODE
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD
English: This is a medicine used to treat angina (chest pain) and lower blood pressure.
Croatian: To je lijek koji se koristi u liječenju angine (bolova u prsima) i za snižavanje krvnog tlaka.
English: If you take more Qtern than you should
Croatian: Ako uzmete više lijeka Qtern nego što ste trebali
English: Do not stop taking Qtern without talking to your doctor first.
Croatian: Nemojte prestati uzimati Qtern ako prethodno o tome niste razgovarali s liječnikom.
English: Your doctor may prescribe other medicines to lower the amount of sugar in your blood.
Croatian: Liječnik Vam može propisati i druge lijekove kako bi snizio količinu šećera u Vašoj krvi.
English: These pharmacokinetic effects are not clinically meaningful and do not require dose adjustment.
Croatian: Ovi farmakokinetički učinci nisu klinički značajni i nije potrebna prilagodba doze.
English: The AUC values of 5-OH-saxagliptin were also increased.
Croatian: Vrijednosti AUC-a 5-OH-saksagliptina također su bile povećane.
English: Difference in HbA1c effect
Croatian: Razlika u učinku na HbA1c
English: SU = sulphonylurea
Croatian: SU = sulfonilureja.
English: Frequency categories were defined according to very common (≥ 1/10), common (≥ 1/100 to ˂ 1/10), uncommon (≥ 1/1000 to ˂ 1/100), rare ( 1/10,000 to < 1/1000) and not known (cannot be estimated from the available data).
Croatian: Kategorije učestalosti su definirane kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100) i rijetko (≥ 1/10 000 i < 1/1000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Your doctor may ask you to stop taking Qtern.
Croatian: Liječnik može zatražiti da prestanete uzimati Qtern.
English: Patients who completed the initial 24-week study period were eligible to enter a controlled 28-week long-term study extension (52 weeks).
Croatian: Bolesnici koji su završili početno 24-tjedno razdoblje ispitivanja mogli su ući u kontrolirani 28-tjedni dugoročni nastavak ispitivanja (52 tjedna).
English: The efficacy and safety profile of Qtern in these patients has not been established.
Croatian: Djelotvornost i sigurnosni profil lijeka Qtern kod tih bolesnika nisu utvrđeni.
English: The numerical imbalance of breast, bladder and prostate tumours must be considered with caution; it will be further investigated in post-authorisation studies.
Croatian: Brojčanu neravnotežu tumora dojke, mokraćnog mjehura i prostate potrebno je razmotriti s oprezom; biti će dodatno ispitano u ispitivanjima nakon stavljanja lijeka u promet.
English: Not known
Croatian: Rijetko Nepoznato
English: • Prior to initiation of concomitant medicinal products that may reduce renal function and periodically thereafter.
Croatian: • prije početka istodobnog liječenja lijekovima koji mogu umanjiti bubrežnu funkciju i periodički nakon toga
English: The majority of patients in this study had a baseline HbA1c of > 8 % (see table 3).
Croatian: Većina bolesnika u tom ispitivanju imala je početnu vrijednost HbA1c > 8% (vidjeti tablicu 3).
English: Use of alternative methods to monitor glycaemic control is advised.
Croatian: Preporučeno je korištenje alternativnih metoda za praćenje regulacije glikemije.
English: - You can take your tablet with or without food.
Croatian: - Tabletu možete uzeti s hranom ili bez nje.
English: This is not considered clinically meaningful, therefore, no dose adjustment for saxagliptin is recommended on the basis of age alone.
Croatian: To se ne smatra klinički značajnim i stoga se ne preporučuje prilagođavati dozu saksagliptina samo na temelju dobi.
English: If pancreatitis is suspected, this medicinal product should be discontinued; if acute pancreatitis is confirmed, it should not be restarted.
Croatian: Posumnja li se na pankreatitis, treba prekinuti primjenu ovog lijeka; ako se akutni pankreatitis potvrdi, liječenje ovim lijekom ne smije se ponovno uvoditi.
English: Qtern can be administered with or without food.
Croatian: Qtern se može primjenjivati s hranom ili bez nje.
English: Use with potent CYP3A4 inducers
Croatian: Primjena sa snažnim induktorima CYP3A4
English: Other medicines and Qtern
Croatian: Drugi lijekovi i Qtern
English: AstraZeneca UK Limited Silk Road Business Park Macclesfield Cheshire SK10 2NA
Croatian: AstraZeneca UK Limited Silk Road Business Park, Macclesfield Cheshire SK10 2NA Ujedinjeno Kraljevstvo
English: Constipation, dry mouth, pancreatitis
Croatian: povraćanje konstipacija, suha usta, pankreatitis
English: Qtern is used for a type of diabetes called “type 2 diabetes mellitus” in adult patients (aged 18 years and older).
Croatian: Qtern se primjenjuje za liječenje jedne vrste šećerne bolesti koja se naziva "šećerna bolest tipa 2" kod odraslih bolesnika (u dobi od 18 ili više godina).
English: Each belongs to a group of medicines called “oral anti-diabetics”.
Croatian: Obje pripadaju skupini lijekova koji se nazivaju oralnim antidijabeticima.