FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients randomized to the placebo group were receiving the placebo plus linagliptin 5 mg with background metformin Mixed-effects models for repeated measurements (MMRM) on FAS (OC) includes baseline HbA1c, baseline eGFR (MDRD), geographical region, visit treatment,and treatment by visit interaction.
Croatian: Bolesnici randomizirani u placebo skupinu primali su placebo plus linagliptin 5 mg uz osnovnu terapiju metforminom Modeli miješanih učinaka za ponovljena mjerenja (engl. mixed-effects models for repeated measurements, MMRM)
English: Each film-coated tablet contains 25 mg empagliflozin and 5 mg linagliptin.
Croatian: Jedna filmom obložena tableta sadrži 25 mg empagliflozina i 5 mg linagliptina.
English: INFORMATION IN BRAILLE Glyxambi 25 mg/5 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Glyxambi 25 mg/5 mg
English: • In patients with an estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 or creatinine clearance (CrCl) ≥60 mL/min, no dose adjustment is required.
Croatian: (eng. estimated glomerular filtration rate, eGFR) ≥ 60 ml/min/1,73 m2 ili klirensom kreatinina
English: Each film-coated tablet contains 10 mg empagliflozin and 5 mg linagliptin.
Croatian: Jedna filmom obložena tableta sadrži 10 mg empagliflozina i 5 mg linagliptina.
English: In clinical trials with Glyxambi, there was no notable difference of the frequency of urinary tract infections in patients treated with Glyxambi (Glyxambi 25 mg/5 mg: 8.5 %; Glyxambi 10 mg/5 mg: 7.5 %) compared to the patients treated with empagliflozin and linagliptin.
Croatian: U kliničkim ispitivanjima lijeka Glyxambi nije bilo primjetne razlike učestalosti infekcija mokraćnog sustava u bolesnika liječenih lijekom Glyxambi (Glyxambi 25 mg/5 mg: 8,5%; Glyxambi 10 mg/5 mg: 7,5%) u usporedbi s bolesnicima liječenim empagliflozinom i linagliptinom.
English: Glyxambi 10 mg/5 mg film-coated tablets Glyxambi 25 mg/5 mg film-coated tablets empagliflozin/linagliptin
Croatian: Glyxambi 10 mg/5 mg filmom obložene tablete Glyxambi 25 mg/5 mg filmom obložene tablete empagliflozin/linagliptin
English: Your doctor may want to lower the dose of these other medicines, to prevent your blood sugar levels from getting too low.
Croatian: • druge lijekove za liječenje šećerne bolesti, poput inzulina ili sulfonilureje; Vaš liječnik će možda htjeti sniziti dozu ovih drugih lijekova kako bi se spriječio nastanak pretjerano niske razine šećera u krvi.
English: Glyxambi 10 mg/5 mg film-coated tablets
Croatian: Glyxambi 10 mg/5 mg filmom obložene tablete
English: Amylase increased
Croatian: Pojačano mokrenje
English: Comparison vs. linagliptin 5 mg - adjusted mean
Croatian: Usporedba naspram linagliptin 5 mg prilagođena srednja vrijednost
English: Glyxambi 25 mg/5 mg film-coated tablets
Croatian: Glyxambi 25 mg/5 mg filmom obložene tablete
English: In the CARMELINA study (see section 5.1), bullous pemphigoid was reported in 0.2% patients treated with linagliptin and in no patients treated with placebo.
Croatian: U ispitivanju CARMELINA (vidjeti dio 5.1) bulozni pemfigoid bio je prijavljen u 0,2% bolesnika liječenih linagliptinom i ni u jednog bolesnika koji je primao placebo. vidjeti dio 4.4 za dodatne informacije vidjeti dio u nastavku
English: In clinical trials with Glyxambi, genital infections in patients treated with Glyxambi (Glyxambi 25 mg/5 mg: 3.0 %; Glyxambi 10 mg/5 mg: 2.5 %) were reported more frequently than for linagliptin but less freqeuntly than for empagliflozin.
Croatian: U kliničkim ispitivanjima lijeka Glyxambi genitalne infekcije u bolesnika liječenih lijekom Glyxambi (Glyxambi 25 mg/5 mg: 3,0%; Glyxambi 10 mg/5 mg: 2,5%) su bile češće prijavljivane u usporedbi s bolesnicima liječenim linagliptinom, ali rjeđe u odnosu na empagliflozin.
English: In clinical trials with Glyxambi, increased urination in patients treated with Glyxambi (Glyxambi 25 mg/5 mg: 2.6 %; Glyxambi 10 mg/5 mg: 1.4 %) was reported more frequently than for linagliptin and with similar frequency than for empagliflozin.
Croatian: U kliničkim ispitivanjima lijeka Glyxambi pojačano mokrenje u bolesnika liječenih lijekom Glyxambi (Glyxambi 25 mg/5 mg: 2,6%; Glyxambi 10 mg/5 mg: 1,4%) je bilo češće prijavljeno u usporedbi s bolesnicima liječenim linagliptinom te sa sličnom učestalošću u usporedbi s bolesnicima liječenim empagliflozinom.
English: CV = cardiovascular, MI = myocardial infarction Treated set (TS), i.e. patients who had received at least one dose of study drug Pooled doses of empagliflozin 10 mg and 25 mg Since data from the trial were included in an interim analysis, a two-sided 95.02% confidence interval applied which corresponds to a p-value of less than 0.0498 for significance.
Croatian: Budući da su podaci iz ispitivanja bili uključeni u interim analizu, primijenjen je dvostrani 95,02%-tni interval pouzdanosti što odgovara p-vrijednosti od manje od 0,0498 za značajnost.
English: Empagliflozin improves both fasting and post prandial plasma glucose levels.
Croatian: Empagliflozin snižava razinu glukoze u plazmi natašte i nakon jela.
English: NAME OF THE MEDICINAL PRODUCT Glyxambi 10 mg/5 mg tablets empagliflozin/linagliptin
Croatian: NAZIV LIJEKA Glyxambi 10 mg/5 mg tablete empagliflozin/linagliptin
English: NAME OF THE MEDICINAL PRODUCT Glyxambi 25 mg/5 mg tablets empagliflozin/linagliptin
Croatian: NAZIV LIJEKA Glyxambi 25 mg/5 mg tablete empagliflozin/linagliptin
English: • In patients with an eGFR <60 mL/min/1.73 m 2 or CrCl <60 mL/min, Glyxambi should not be initiated.
Croatian: • Terapija lijekom Glyxambi ne smije se započeti u bolesnika s eGFR< 60 ml/min/1,73 m 2 ili
English: However, temporary interruption of Glyxambi should be considered in patients with complicated urinary tract infections.
Croatian: Međutim, u bolesnika s kompliciranim infekcijama mokraćnog sustava potrebno je razmotriti privremeni prekid terapije lijekom Glyxambi.
English: NAME OF THE MEDICINAL PRODUCT Glyxambi 10 mg/5 mg film-coated tablets Glyxambi 25 mg/5 mg film-coated tablets
Croatian: Glyxambi 10 mg/5 mg filmom obložene tablete Glyxambi 25 mg/5 mg filmom obložene tablete
English: Glyxambi 25 mg/5 mg film-coated tablets EU/1/16/1146/010 (7 x 1 film-coated tablets) EU/1/16/1146/011 (10 x 1 film-coated tablets) EU/1/16/1146/012 (14 x 1 film-coated tablets) EU/1/16/1146/013 (28 x 1 film-coated tablets) EU/1/16/1146/014 (30 x 1 film-coated tablets) EU/1/16/1146/015 (60 x 1 film-coated tablets) EU/1/16/1146/016 (70 x 1 film-coated tablets) EU/1/16/1146/017 (90 x 1 film-coated tablets) EU/1/16/1146/018 (100 x 1 film-coated tablets)
Croatian: Glyxambi 25 mg/5 mg filmom obložene tablete EU/1/16/1146/010 (7 x 1 filmom obložena tableta) EU/1/16/1146/011 (10 x 1 filmom obložena tableta) EU/1/16/1146/012 (14 x 1 filmom obložena tableta) EU/1/16/1146/013 (28 x 1 filmom obložena tableta) EU/1/16/1146/014 (30 x 1 filmom obložena tableta) EU/1/16/1146/015 (60 x 1 filmom obložena tableta) EU/1/16/1146/016 (70 x 1 filmom obložena tableta) EU/1/16/1146/017 (90 x 1 filmom obložena tableta) EU/1/16/1146/018 (100 x 1 filmom obložena tableta)
English: The study population included 1211 (17.4 %) patients ≥ 75 years of age, the mean HbA1c was 8.0 %, 63 % were male.
Croatian: Ispitivana populacija uključivala je 1211 (17,4%) bolesnika u dobi
English: Hepatic impairment:
Croatian: Oštećenje jetrene funkcije:
English: EU/1/16/1146/010 7 x 1 film-coated tablets EU/1/16/1146/011 10 x 1 film-coated tablets EU/1/16/1146/012 14 x 1 film-coated tablets EU/1/16/1146/013 28 x 1 film-coated tablets EU/1/16/1146/014 30 x 1 film-coated tablets EU/1/16/1146/015 60 x 1 film-coated tablets EU/1/16/1146/016 70 x 1 film-coated tablets EU/1/16/1146/017 90 x 1 film-coated tablets EU/1/16/1146/018 100 x 1 film-coated tablets
Croatian: EU/1/16/1146/010 7 x 1 filmom obložena tableta EU/1/16/1146/011 10 x 1 filmom obložena tableta EU/1/16/1146/012 14 x 1 filmom obložena tableta EU/1/16/1146/013 28 x 1 filmom obložena tableta EU/1/16/1146/014 30 x 1 filmom obložena tableta EU/1/16/1146/015 60 x 1 filmom obložena tableta EU/1/16/1146/016 70 x 1 filmom obložena tableta EU/1/16/1146/017 90 x 1 filmom obložena tableta EU/1/16/1146/018 100 x 1 filmom obložena tableta
English: EU/1/16/1146/001 7 x 1 film-coated tablets EU/1/16/1146/002 10 x 1 film-coated tablets EU/1/16/1146/003 14 x 1 film-coated tablets EU/1/16/1146/004 28 x 1 film-coated tablets EU/1/16/1146/005 30 x 1 film-coated tablets EU/1/16/1146/006 60 x 1 film-coated tablets EU/1/16/1146/007 70 x 1 film-coated tablets EU/1/16/1146/008 90 x 1 film-coated tablets EU/1/16/1146/009 100 x 1 film-coated tablets
Croatian: EU/1/16/1146/001 7 x 1 filmom obložena tableta EU/1/16/1146/002 10 x 1 filmom obložena tableta EU/1/16/1146/003 14 x 1 filmom obložena tableta EU/1/16/1146/004 28 x 1 filmom obložena tableta EU/1/16/1146/005 30 x 1 filmom obložena tableta EU/1/16/1146/006 60 x 1 filmom obložena tableta EU/1/16/1146/007 70 x 1 filmom obložena tableta EU/1/16/1146/008 90 x 1 filmom obložena tableta EU/1/16/1146/009 100 x 1 filmom obložena tableta
English: Glyxambi 10 mg/5 mg film-coated tablets EU/1/16/1146/001 (7 x 1 film-coated tablets) EU/1/16/1146/002 (10 x 1 film-coated tablets) EU/1/16/1146/003 (14 x 1 film-coated tablets) EU/1/16/1146/004 (28 x 1 film-coated tablets) EU/1/16/1146/005 (30 x 1 film-coated tablets) EU/1/16/1146/006 (60 x 1 film-coated tablets) EU/1/16/1146/007 (70 x 1 film-coated tablets) EU/1/16/1146/008 (90 x 1 film-coated tablets) EU/1/16/1146/009 (100 x 1 film-coated tablets)
Croatian: Glyxambi 10 mg/5 mg filmom obložene tablete EU/1/16/1146/001 (7 x 1 filmom obložena tableta) EU/1/16/1146/002 (10 x 1 filmom obložena tableta) EU/1/16/1146/003 (14 x 1 filmom obložena tableta) EU/1/16/1146/004 (28 x 1 filmom obložena tableta) EU/1/16/1146/005 (30 x 1 filmom obložena tableta) EU/1/16/1146/006 (60 x 1 filmom obložena tableta) EU/1/16/1146/007 (70 x 1 filmom obložena tableta) EU/1/16/1146/008 (90 x 1 filmom obložena tableta) EU/1/16/1146/009 (100 x 1 filmom obložena tableta)
English: Non-CV mortality N (%) Hazard ratio vs. placebo (95% CI)
Croatian: Moždani udar bez smrtnog ishoda N (%) Omjer hazarda naspram placeba (95% CI) p−vrijednost Mortalitet svih uzroka N (%) Omjer hazarda naspram placeba (95% CI) p-vrijednost Nekardiovaskularni mortalitet N (%) Omjer hazarda naspram placeba (95% CI)
English: STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 25 mg empagliflozin and 5 mg linagliptin.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 25 mg empagliflozina i 5 mg linagliptina.
English: STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 10 mg empagliflozin and 5 mg linagliptin.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 10 mg empagliflozina i 5 mg linagliptina.
English: Increased urination Dysuria
Croatian: Pojačano mokrenje Dizurija
English: It is not known whether Glyxambi is harmful to the unborn child. As a precautionary measure it is preferrable to avoid the use of this medicine during pregnancy.
Croatian: Nije poznato je li Glyxambi štetan za nerođeno dijete.
English: NAME OF THE MEDICINAL PRODUCT Glyxambi 10 mg/5 mg film-coated tablets empagliflozin/linagliptin
Croatian: Glyxambi 10 mg/5 mg filmom obložene tablete empagliflozin/linagliptin
English: 100 ml vial
Croatian: Karencija bočica 100
English: Pharmaceutical form
Croatian: Farmac eutski oblik
English: ● severe allergic reactions
Croatian: ● teške alergijske reakcije
English: Adults and adolescents 12 years of age and over
Croatian: Odrasli i adolescenti u dobi od 12 godina i stariji
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koji druge lijekove.
English: Do not use this medicine if you notice any change in the appearance of the tablets.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primjetite bilo kakvu promjenu izgleda tableta.
English: Date of first authorisation: 24 November 2011 Date of latest renewal: 8 August 2016
Croatian: Datum posljednje obnove odobrenja: 8. kolovoza 2016.
English: Desloratadine Teva with food, drink and alcohol
Croatian: Desloratadin Teva s hranom, pićem i alkoholom
English: < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Croatian: < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The recommended dose is one tablet once a day with water, with or without food.
Croatian: Preporučena doza je jedna tableta jedanput na dan, a uzima se s vodom, uz obrok ili natašte.
English: Packs of 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 90, 100 and 105 film-coated tablets.
Croatian: Pakiranja od 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 90, 100 i 105 filmom obloženih tableta.
English: Desloratadine Teva may be taken with or without a meal.
Croatian: Desloratadin Teva se može uzeti uz ili bez obroka.
English: Common: the following may affect up to 1 in 10 people
Croatian: Česte: sljedeće nuspojave mogu se javiti u do 1 na 10 osoba:
English: Treatment with desloratadine also significantly reduced interference with sleep and daytime function, as measured by a fourpoint scale used to assess these variables.
Croatian: Liječenje desloratadinom također je značajno smanjilo utjecaj na spavanje i dnevne aktivnosti, što se mjerilo skalom od četiri stupnja za procjenu tih varijabli.
English: Talk to your doctor or pharmacist before taking Desloratadine Teva
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Desloratadin Teva.
English: Very rare: the following may affect up to 1 in 10,000 people
Croatian: Vrlo rijetke: sljedeće nuspojave mogu se javiti u do 1 na 10 000 osoba:
English: OPA/Alu/PVC - Aluminium blisters.
Croatian: OPA/Alu/PVC-aluminij blisteri.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude temeljem konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala,
English: Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Desloratadine Teva.
Croatian: Vezano za trajanje liječenja, Vaš će liječnik odrediti od kojeg tipa alergijskog rinitisa bolujete te koliko dugo trebate uzimati Desloratadin Teva.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili glukoza-galaktoza malapsorpcijom ne smiju uzimati ovaj lijek.
English: Adults and adolescents (12 years of age and over) The recommended dose of Desloratadine Teva 5 mg film-coated tablets is one tablet once a day.
Croatian: Odrasli i adolescenti (u dobi od 12 godina i stariji) Preporučena doza lijeka Desloratadin Teva 5 mg filmom obložene tablete je jedna tableta jedanput na dan.
English: Other medicines and Desloratadine Teva
Croatian: Drugi lijekovi i Desloratadin Teva
English: ● liver inflammation ● abnormal liver function tests body movement Not known: frequency cannot be estimated from the available data
Croatian: ● odstupanja od normalnih rezultata pokretima tijela testova jetrene funkcije Nepoznata učestalost: ne može se procijeniti iz dostupnih podataka
English: Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures
Croatian: Omaglica, somnolencija, nesanica, psihomotorna hiperaktivnost, napadaji
English: Each film-coated tablet contains 1.2 mg of lactose monohydrate (see section 4.4).
Croatian: Jedna filmom obložena tableta sadrži 1,2 mg laktoza hidrata (vidjeti dio 4.4.)
English: Use caution when taking Desloratadine Teva with alcohol.
Croatian: Potreban je oprez kada se Desloratadin Teva uzima s alkoholom.
English: Desloratadine Teva 5 mg
Croatian: Desloratadin Teva 5 mg
English: ● yellowing of the skin and/or eyes ● increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to UV
Croatian: ● povećana osjetljivost kože na sunčevu svjetlost, čak i u slučaju slabog sunca, i na UV (ultraljubičastu) svjetlost, na primjer UV svjetlost solarija
English: There are no known interactions of Desloratadine Teva with other medicines.
Croatian: Nema poznatih interakcija između lijeka Desloratadin Teva i drugih lijekova.
English: Contents of the pack and other information What Desloratadine Teva contains
Croatian: Sadržaj pakiranja i druge informacije Što Desloratadin Teva sadrži
English: The safety and efficacy of Desloratadine Teva 5 mg film-coated tablets in children below the age of 12 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka Desloratadin Teva 5 mg filmom obložene tablete u djece mlađe od 12 godina nisu ustanovljene.
English: How to store Desloratadine Teva Contents of the pack and other information
Croatian: Kako čuvati Desloratadin Teva Sadržaj pakiranja i druge informacije
English: Desloratadine Teva contains desloratadine which is an antihistamine.
Croatian: Desloratadin Teva sadrži desloratadin koji je antihistaminik.
English: • if you are allergic to desloratadine, or any of the other ingredients of this medicine (listed in section 6) or to loratadine.
Croatian: • ako ste alergični (preosjetljivi) na desloratadin, ili na neki drugi sastojak lijeka Desloratadin Teva (naveden u dijelu 6.) ili na loratadin.
English: If you take more Desloratadine Teva than you should
Croatian: Ako uzmete više Desloratadina Teva nego što ste trebali
English: What Desloratadine Teva looks like and contents of the pack
Croatian: Kako Desloratadin Teva izgleda i sadržaj pakiranja
English: It also contains lactose monohydrate.
Croatian: Također sadrži laktozu hidrat.
English: A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Desloratadine Teva 5 mg film-coated tablets therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Desloratadin Teva 5 mg filmom obložene tablete uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Podrobnije informacije o ovom lijeku dostupne su na web stranicama Europske agencije za lijekove http://www.ema.europa.eu.
English: Increased appetite
Croatian: ● povećan apetit
English: Tachycardia, palpitations QT prolongation
Croatian: Tahikardija, palpitacije Produljenje QT intervala
English: What Desloratadine Teva is and what it is used for What Desloratadine Teva is
Croatian: Što je Desloratadin Teva i za što se koristi Što je Desloratadin Teva
English: Desloratadine Teva 5 mg film-coated tablets are supplied in blister packs of 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 90, 100 and 105 film-coated tablets and in perforated blister packs of 50 x 1 film-coated tablet (unit dose).
Croatian: Desloratadin Teva 5 mg filmom obložene tablete su dostupne u blisterima od 7, 10, 14, 20, 21, 28, 30, 40,50,60, 90, 100 i 105 filmom obloženih tableta te u perforiranim blisterima od 50 x 1 filmom obložena tableta (jedinična doza).
English: During the marketing of Desloratadine Teva, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely.
Croatian: Nakon stavljanja u promet lijeka Desloratadin Teva, slučajevi teških alergijskih reakcija (otežano disanje, zviždanje pri disanju, svrbež, koprivnjača i oticanje) bili su prijavljeni vrlo rijetko.
English: In the case of severe renal insufficiency, Desloratadine Teva 5 mg film-coated tablets should be used with caution (see section 5.2).
Croatian: U slučaju teške insuficijencije bubrega, Desloratadin Teva 5 mg filmom obložene tablete treba oprezno primjenjivati (vidjeti dio 5.2).
English: There is no evidence of clinically relevant medicine accumulation following once daily dosing of desloratadine (5 mg to 20 mg) for 14 days.
Croatian: Ne postoji dokaz o klinički značajnoj akumulaciji lijeka nakon primjene desloratadina jednom dnevno (5 mg do 20 mg) tijekom
English: Desloratadine Teva relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older.
Croatian: Desloratadin Teva ublažava simptome povezane s alergijskim rinitisom (upala nosnih puteva uzrokovana alergijom, na primjer, kod peludne groznice ili alergije na grinje) u odraslih osoba i adolescenata u dobi od 12 ili više godina.
English: In a clinical trial with 578 adolescent patients, 12 through 17 years of age, the most common adverse event was headache; this occurred in 5.9 % of patients treated with desloratadine and 6.9 % of patients receiving placebo.
Croatian: U kliničkom ispitivanju s 578 ispitanika adolescenata, u dobi od 12 do 17 godina, najčešći štetni događaj bila je glavobolja koja se javljala u 5,9 % bolesnika liječenih desloratadinom i u 6,9 %
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da imate bolest nepodnošenja nekih šećera, prije nego što počnete uzimati ovaj lijek posavjetujte se sa svojim liječnikom.
English: Desloratadine Teva is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with: - allergic rhinitis (see section 5.1) - urticaria (see section 5.1)
Croatian: Desloratadin Teva je indiciran u odraslih i adolescenata u dobi od 12 ili više godina za ublažavanje simptoma povezanih s: - alergijskim rinitisom (vidjeti dio 5.1), - urtikarijom (vidjeti dio 5.1).
English: OPA/Alu/PVC - Aluminium perforated unit dose blisters.
Croatian: OPA/Alu/PVC-aluminij perforirani blisteri djeljivi na jedinične doze.
English: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom or
Croatian: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, Ujedinjeno Kraljevstvo ili
English: - The other ingredients are microcrystalline cellulose, pregelatinised maize starch, talc, silica colloidal anhydrous, lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine (E132), shellac and propylene glycol.
Croatian: - Pomoćne tvari su: mikrokristalična celuloza, prethodno geliran kukuruzni škrob, talk, koloidni bezvodni silicijev dioksid, laktoza hidrat, hipromeloza, titanijev dioksid (E171), makrogol 400, indigo carmine (E132), šelak i propilenglikol.
English: Merckle GmbH Ludwig-Merckle-Strasse 3 D-89143 Blaubeuren Germany
Croatian: Merckle GmbH Ludwig-Merckle-Strasse 3 D-89143 Blaubeuren
English: Pack of 50 x 1 film-coated tablet (unit dose).
Croatian: Pakiranje od 50 x 1 filmom obložena tableta (jedinična doza).
English: In both studies, changes in exposure (AUC and Cmax) of desloratadine and 3-hydroxydesloratadine were not clinically relevant.
Croatian: U oba ispitivanja promjene u izloženosti (AUC i Cmax) desloratadinu i 3
English: Desloratadine Teva is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Croatian: Desloratadin Teva se također koristi za ublažavanje simptoma povezanih s urtikarijom (promjene na koži uslijed alergije).
English: As a precautionary measure, it is preferable to avoid the use of Desloratadine Teva 5 mg film-coated tablets during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Desloratadin Teva 5 mg filmom obložene tablete tijekom trudnoće.
English: Adults During the marketing of Desloratadine Teva, the following side effects were reported as:
Croatian: Odrasli Nakon stavljanja u promet lijeka Desloratadin Teva, sljedeće su nuspojave prijavljene kao: