FrancophonIA/ELRC3.0 huggingface dataset:
English: What Dasselta is and what it is used for What you need to know before you take Dasselta How to take Dasselta
Croatian: Što se nalazi u ovoj uputi Što je Dasselta i za što se koristi Što morate znati prije nego počnete uzimati Dasseltu Kako uzimati Dasseltu
English: Common (the following may affect up to 1 in 10 people): - fatigue, - dry mouth, - headache.
Croatian: Česte (sljedeće nuspojave mogu se javiti u do 1 na 10 osoba) - umor - suha usta - glavobolja
English: Not known: frequency cannot be estimated from the available data - slow heartbeat, - change in the way the heart beats, - abnormal behaviour, - aggression.
Croatian: Nepoznata učestalost: ne može se procijeniti iz dostupnih podataka - usporen rad srca - promjene u načinu otkucaja srca - neuobičajeno ponašanje - agresija.
English: For urticaria, the duration of treatment may be variable from patient to patient and therefore you should follow the instructions of your doctor.
Croatian: Trajanje liječenja urtikarije razlikuje se od bolesnika do bolesnika, stoga trebate slijediti upute svog liječnika.
English: There are no known interactions of Dasselta with other medicines.
Croatian: Nema poznatih interakcija između lijeka Dasselta i drugih lijekova.
English: An improvement in pruritus of more than 50 % was observed in 55 % of patients treated with desloratadine compared with 19 % of patients treated with placebo.
Croatian: Zabilježeno je smanjenje svrbeža za više od 50% u 55% bolesnika liječenih desloratadinom, u usporedbi s 19% bolesnika koji su primali placebo.
English: In the case of severe renal insufficiency, Dasselta should be used with caution (see section 5.2).
Croatian: U slučaju teške insuficijencije bubrega, Dasseltu treba oprezno primjenjivati (vidjeti dio 5.2).
English: Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake „EXP“.
English: Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to loratadine.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili na loratadin.
English: Adults and adolescents (12 years of age and over) The recommended dose of Dasselta is one tablet once a day.
Croatian: Odrasli i adolescenti (u dobi od 12 godina i stariji) Preporučena doza lijeka Dasselta je jedna tableta jedanput na dan.
English: film-coated tablet for blister:
Croatian: filmom obložena tableta za blister:
English: Excipient with known effect: Each film-coated tablet contains 16.15 mg lactose (as monohydrate).
Croatian: Pomoćna tvar s poznatim učinkom: Jedna filmom obložena tableta sadrži 16,15 mg laktoze (u obliku hidrata).
English: Tablet container (HDPE, volume 60 ml), PP closure with desiccant: 250 film-coated tablets, in a box.
Croatian: Spremnik za tablete (HDPE, volumen 60 ml), plastični (PP) zatvarač sa sredstvom za sušenje: 250 filmom obloženih tableta, u kutiji.
English: Dasselta 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: Dasselta je indicirana 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: In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, desloratadine was effective in relieving pruritus and decreasing the size and number of hives by the end of the first dosing interval.
Croatian: U dva placebom kontrolirana ispitivanja u trajanju od šest tjedana u bolesnika s kroničnom idiopatskom urtikarijom, desloratadin je učinkovito ublažavao svrbež i smanjivao veličinu i broj koprivnjača do kraja prvog intervala doziranja.
English: 7 film-coated tablets 10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 90 film-coated tablets 100 film-coated tablets for tablet container: 250 film-coated tablets
Croatian: 7 filmom obloženih tableta 10 filmom obloženih tableta 20 filmom obloženih tableta 30 filmom obloženih tableta 50 filmom obloženih tableta 90 filmom obloženih tableta 100 filmom obloženih tableta za spremnik za tablete: 250 filmom obloženih tableta
English: During the marketing of desloratadine, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely.
Croatian: Nakon stavljanja desloratadina u promet, slučajevi teških alergijskih reakcija (otežano disanje, zviždanje pri disanju, svrbež, koprivnjača i oticanje) bili su prijavljeni vrlo rijetko.
English: Dasselta is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Croatian: Dasselta se također koristi za ublažavanje simptoma povezanih s urtikarijom (promjene na koži uslijed alergije).
English: After oral administration, desloratadine selectively blocks peripheral histamine H1receptors because the substance is excluded from entry to the central nervous system.
Croatian: Nakon peroralne primjene, desloratadin selektivno blokira periferne histaminske H1-receptore budući da ne prodire u središnji živčani sustav.
English: In clinical studies with desloratadine, the following side effects were reported as:
Croatian: U kliničkim ispitivanjima s loratadinom, sljedeće nuspojave bile su prijavljene kao:
English: Dasselta 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: Dasselta 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: 250 film-coated tablets
Croatian: 250 filmom obloženih tableta
English: Each film-coated tablet contains 5 mg desloratadine.
Croatian: Jedna filmom obložena tableta sadrži 5 mg desloratadina.
English: Dasselta is available in carton boxes of 7, 10, 20, 30, 50, 90 and 100 film-coated tablets in blisters and in tablet container of 250 film-coated tablets.
Croatian: Dasselta je dostupna u kutijama od 7, 10, 20, 30, 50, 90 i 100 filmom obloženih tableta u blisterima te u spremniku za tablete koji sadrži 250 film obloženih tableta.
English: What Dasselta is Dasselta contains desloratadine which is an antihistamine.
Croatian: Što je Dasselta Dasselta sadrži desloratadin, koji je antihistaminik.
English: Dasselta is an antiallergy medicine that does not make you drowsy.
Croatian: Dasselta je lijek protiv alergije koji ne izaziva pospanost.
English: If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your doctor will recommend you a treatment schedule that will depend on the evaluation of the history of your disease.
Croatian: Ako je Vaš alergijski rinitis intermitentni (simptomi su prisutni manje od 4 dana u tjednu ili manje od 4 tjedna), Vaš liječnik će Vam preporučiti raspored liječenja koji će ovisiti o procjeni Vaše povijesti bolesti.
English: Use caution when taking Dasselta with alcohol.
Croatian: Potreban je oprez kada se Dasselta uzima s alkoholom.
English: In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with desloratadine were reported in 3 % of patients in excess of those treated with placebo.
Croatian: U kliničkim ispitivanjima kod različitih indikacija, uključujući alergijski rinitis i kroničnu idiopatsku urtikariju, pri preporučenoj dozi od 5 mg dnevno, kod primjene desloratadina zabilježene su nuspojave u 3% više bolesnika nego u onih koji su primali placebo.
English: Not known: frequency cannot be estimated from the available data - unusual weakness, - 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 lights of a solarium, - changes in the way the heart beats,
Croatian: Nepoznate: učestalost se ne može procijeniti iz dostupnih podataka - neuobičajena slabost - žutilo kože i/ili očiju - povećana osjetljivost kože na sunčevu svjetlost, čak i u slučaju slabog sunca, i na UV
English: Light blue, round, film-coated tablets with beveled edges (diameter: 6.5 mm, thickness: 2.3-3.5 mm).
Croatian: Svijetlo plave, okrugle, filmom obložene tablete s ukošenim rubovima (promjera: 6,5 mm, debljine: 2,3-3,5 mm).
English: In a clinical pharmacology trial desloratadine tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Croatian: U kliničkom farmakološkom ispitivanju, uzimanje tableta desloratadina istodobno s alkoholom nije pojačalo štetne učinke alkohola na ponašanje (vidjeti dio 5.1).
English: Fertility There is no data available on male/female fertility.
Croatian: Plodnost Nisu dostupni podaci o plodnosti u muškaraca/žena.
English: Other undesirable effects reported during the post-marketing period in paediatric patients with an unknown frequency included QT prolongation, arrhythmia, bradycardia, abnormal behaviour and aggression.
Croatian: Ostale nuspojave nepoznate učestalosti prijavljene u pedijatrijskih bolesnika nakon stavljanja lijeka u promet uključivale su produljenje QT intervala, aritmiju, bradikardiju, neuobičajeno ponašanje i agresiju.
English: Excipient: lactose monohydrate.
Croatian: Pomoćna tvar: laktoza hidrat.
English: As with other antihistamine trials in chronic idiopathic urticaria, the minority of patients who were identified as nonresponsive to antihistamines was excluded.
Croatian: Kao i kod drugih ispitivanja antihistaminika kod kronične idiopatske urtikarije, manji broj pacijenata, u kojih je utvrđeno da ne reagiraju na antihistaminike, bio je isključen iz ispitivanja.
English: Elevations of liver enzymes, increased bilirubin, hepatitis
Croatian: Poremećaji jetre i žuči vrlo rijetko nepoznato povećanje jetrenih enzima, povišeni bilirubin, hepatitis žutica
English: If you are pregnant or nursing a baby, taking Dasselta is not recommended.
Croatian: Ako ste trudni ili dojite, nije preporučljivo uzimati Dasseltu.
English: In clinical pharmacology trials, co-administration with alcohol did not increase the alcohol-induced impairment in performance or increase in sleepiness.
Croatian: U kliničkim farmakološkim ispitivanjima, istodobna primjena desloratadina i alkohola nije pojačala štetne učinke alkohola na ponašanje ili povećala pospanost.
English: In a single dose study performed in adults, desloratadine 5 mg did not affect standard measures of flight performance including exacerbation of subjective sleepiness or tasks related to flying.
Croatian: U ispitivanju učinka jednokratnih doza desloratadina od 5 mg u odraslih osoba, nije bilo utjecaja na standardna mjerila uspješnosti upravljanja letjelicama, uključujući i egzacerbaciju subjektivnog osjećaja pospanosti ili zadataka vezanih uz upravljanje letjelicama.
English: In patients with allergic rhinitis, desloratadine was effective in relieving symptoms such as sneezing, nasal discharge and itching, as well as ocular itching, tearing and redness, and itching of palate.
Croatian: U bolesnika s alergijskim rinitisom, desloratadin je bio učinkovit u ublažavanju simptoma kao što su kihanje, curenje i svrbež nosa, kao i svrbež, suzenje i crvenilo očiju te svrbež nepca.
English: How to take Dasselta
Croatian: Kako uzimati Dasseltu
English: What Dasselta contains - The active substance is desloratadine.
Croatian: Što Dasselta sadrži - Djelatna tvar je desloratadin.
English: However, cases of alcohol intolerance and intoxication have been reported during post marketing use.
Croatian: Međutim, nakon stavljanja lijeka u promet prijavljeni su slučajevi intolerancije alkohola i intoksikacije.
English: Dasselta 5 mg film-coated tablets
Croatian: Dasselta 5 mg filmom obložene tablete
English: Dasselta contains lactose
Croatian: Dasselta sadrži laktozu
English: In clinical studies in adults, side effects were about the same as with a dummy tablet.
Croatian: U kliničkim ispitivanjima u odraslih osoba nuspojave su bile slične s onima kod uzimanja tablete placeba.
English: During the marketing of desloratadine-containing products, the following side effects were reported as:
Croatian: Odrasli Nakon stavljanja Dasselte u promet sljedeće su nuspojave prijavljene kao:
English: Dasselta 5 mg film-coated tablets Desloratadine
Croatian: Dasselta 5 mg filmom obložene tablete desloratadin
English: Microcrystalline cellulose (E460) Hypromellose (E464) Hydrochloric acid (E507) Sodium hydroxide (E524) Maize starch
Croatian: Jezgra tablete: celuloza, mikrokristalična (E460) hipromeloza (E464) kloridna kiselina (E507) natrijev hidroksid (E524) kukuruzni škrob laktoza hidrat talk (E553b)
English: How to store Dasselta
Croatian: Kako čuvati Dasseltu
English: Lactose monohydrate Titanium dioxide (E171) Indigo carmine (E132)
Croatian: Film ovojnica: hipromeloza (E464) makrogol laktoza hidrat titanijev dioksid (E171) indigotin (E132)
English: Dasselta contains lactose.
Croatian: Dasselta sadrži laktozu.
English: - The other ingredients in the tablet core are: microcrystalline cellulose (E460), hypromellose (E464), hydrochloric acid (E507), sodium hydroxide (E524), maize starch, lactose monohydrate (see section 2 under »Dasselta contains lactose«.)
Croatian: - Drugi sastojci u jezgri tablete su mikrokristalična celuloza (E460), hipromeloza (E464), kloridna kiselina (E507), natrijev hidroksid (E524), kukuruzni škrob, laktoza hidrat (vidjeti dio 2 pod „Dasselta sadrži laktozu“) i talk (E553b).
English: When Dasselta should be used
Croatian: Kada treba uzimati Dasseltu
English: Metabolism and nutritional disorders
Croatian: Poremećaji metabolizma i prehrane nepoznato povećan apetit
English: Desloratadine has no or negligible influence on the ability to drive and use machines based on clinical trials.
Croatian: Temeljem rezultata kliničkih ispitivanja desloratadin ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: No serious side effects are expected with accidental overdose.
Croatian: Kod slučajnog predoziranja ne biste trebali imati ozbiljnijih nuspojava.
English: - The other ingredients in the film-coating are: hypromellose (E464), macrogol, lactose monohydrate (see section 2 under »Dasselta contains lactose«.
Croatian: - Drugi sastojci u film ovojnici su hipromeloza (E464), makrogol, laktoza hidrat (vidjeti dio 2 pod „Dasselta sadrži laktozu“), titanijev dioksid (E171) i indigotin (E132).
English: Dry mouth
Croatian: Za primjenu kroz usta
English: However, if you take more Dasselta than you were told to, tell your doctor or pharmacist immediately.
Croatian: Vam je propisano, obratite se odmah svom liječniku ili ljekarniku.
English: TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Croatian: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Njemačka
English: Tablet core:
Croatian: Peroralna primjena.
English: Increased appetite
Croatian: ROK VALJANOSTI
English: Adults
Croatian: Proizvođači
English: Photosensitivity
Croatian: Način primjene
English: There is a possibility that this may lead to hypermagnesaemia.
Croatian: Postoji mogućnost da će to dovesti do hipermagnezijemije.
English: <Invented Name> provides 0.3 mmol/kg/d of magnesium when administered at maximum dose (see section 4.2).
Croatian: <Zaštićeno ime> daje 0,3 mmol/kg/d magnezija kada se primjenjuje maksimalna doza (vidjeti dio 4.2).
English: Elevated levels of Magnesium in blood
Croatian: Povišene razine magnezija u krvi
English: Hypermagnesaemia
Croatian: Hipermagnezijemija
English: If blood magnesium levels are elevated, the infusion will be stopped or reduced.
Croatian: Ako su povišene razine magnezija u krvi, infuzija će se zaustaviti ili smanjiti.
English: This is especially important in those patients at increased risk of developing hypermagnesaemia including patients with impaired renal function, patients receiving other medicinal products which place them at risk of developing hypermagnesaemia or patients receiving magnesium from other sources, including neonates whose mother's recently received magnesium in the antepartum period.
Croatian: To je naročito važno kod onih bolesnika koji imaju povećani rizik od razvoja hipermagnezijemije, uključujući bolesnike s oštećenom funkcijom bubrega, bolesnike koji dobivaju druge lijekove zbog kojih su pod rizikom od razvoja hipermagnezijemije ili bolesnika koji dobivaju magnezij iz drugih izvora, uključujući novorođenčad čije su majke nedavno primile magnezij u razdoblju prije poroda.
English: Summary of Product Characteristics of Numeta G16%E, and associated names
Croatian: Uputa o lijeku za Numeta G16%E, i povezana imena
English: As signs of hypermagnesaemia may not be detected, monitoring of magnesium levels is advised at baseline and at appropriate intervals thereafter, in accordance with routine clinical practice and the needs of the individual patient.
Croatian: Kako znakovi hipermagnezijemije možda neće biti otkriveni, praćenje razina magnezija preporučuje se na početku i u odgovarajućim intervalima nakon toga, u skladu s rutinskom kliničkom praksom i potrebama pojedinačnog bolesnika.
English: As these signs may be difficult to detect, your child´s blood values may be monitored by their doctor, in particular if your child has risk factors for elevated levels of magnesium in blood, including impaired renal function.
Croatian: Budući da ove znakove može biti teško ustanoviti, liječnik će možda nadzirati parametre u krvi Vašeg djeteta, osobito ako Vaše dijete ima rizične faktore za povišenje razina magnezija u krvi, uključujući oštećenu funkciju bubrega.
English: The amount of magnesium in <Invented Name>, may cause elevated levels of magnesium in blood.
Croatian: Količina magnezija u lijeku <Zaštićeno ime> može uzrokovati povišene razine magnezija u krvi.
English: If serum magnesium levels are elevated (above reference range normal values) the infusion of <Invented Name> should be stopped or infusion rate reduced as deemed clinically appropriate and safe.
Croatian: Ako su razine magnezija u serumu povećane (iznad referentnih raspona normalnih vrijednosti), infuziju lijeka <Zaštićeno ime> treba prekinuti ili smanjiti brzinu infuzije kako se smatra klinički prikladnim i sigurnim.
English: [This wording should be inserted at the end of the section]
Croatian: [Potrebno je umetnuti ovaj tekst na kraju dijela]
English: Fluid and electrolyte status including magnesium (see Hypermagnesaemia) should be closely monitored in these patients.
Croatian: Potrebno je pomno nadzirati status tekućine i elektrolita uključujući magnezij (vidjeti Hipermagnezijemija) u ovih bolesnika.
English: Use with caution in patients with renal insufficiency.
Croatian: Lijek treba koristiti s oprezom u bolesnika s insuficijencijom bubrega.
English: The signs of hypermagnesaemia include generalised weakness, hypo-reflexia, nausea, vomiting, hypocalcaemia, respiratory failure, hypotension and arrhythmias.
Croatian: Znakovi hipermagnezijemije uključuju generaliziranu slabost, hiporefleksiju, mučninu, povraćanje, hipokalcemiju, respiratorno zatajenje, hipotenziju i aritmije.
English: The signs of this could include weakness, slow reflexes, nausea, vomiting, low calcium levels in blood, breathing difficulties, low blood pressure and irregular heartbeat.
Croatian: Znakovi koji upućuju na to uključuju slabost, usporene reflekse, mučninu, povraćanje, niske razine kalcija u krvi, teškoće s disanjem, sniženi krvni tlak i nepravilan srčani ritam.
English: [This wording should be inserted at the top of the SmPC] This medicinal product is subject to additional monitoring.
Croatian: [Potrebno je umetnuti ovaj tekst na početku upute o lijeku] Ovaj je lijek pod dodatnim praćenjem.
English: [The wording below should be added to this section]
Croatian: [Potrebno je umetnuti sljedeći tekst u ovaj dio]
English: Section 4.4 Special warnings and precautions for use Renal [This wording should be inserted]
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi
English: Note:
Croatian: Bubrezi
English: Severe water and electrolyte equilibration disorders, severe fluid overload states, and severe metabolic disorders should be corrected before starting the infusion.
Croatian: Prije započinjanja s infuzijom moraju se korigirati teški poremećaji ravnoteže vode i elektrolita, teška stanja opterećenja tekućinom i teški metabolički poremećaji (vidjeti 4.3 Kontraindikacije).
English: The tablets are to be taken at least one hour before or after a meal.
Croatian: Tablete se uzimaju najmanje jedan sat prije ili poslije obroka.
English: It is used for the treatment of adults and children over the age of two years with:
Croatian: Primjenjuje se za liječenje odraslih i djece starije od dvije godine s:
English: This summary was last updated in 12-2015.
Croatian: Ovaj sažetak je posljednji put ažuriran u prosincu 2015.
English: Patients need to receive an initial higher dose (loading dose) on the first day of treatment.
Croatian: Bolesnici moraju primiti početnu veću dozu (udarnu dozu) prvoga dana liječenja.
English: The full EPAR for Voriconazole Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za Voriconazole Accord nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The dose may be increased or decreased according to how the patient responds.
Croatian: Doza se može povećati ili smanjiti ovisno o tome kako bolesnik podnosi lijek.
English: Without ergosterol, the fungus is killed or prevented from spreading.
Croatian: Bez ergosterola, gljivica umire ili je onemogućeno njezino širenje.
English: Voriconazole Accord is available as tablets (50 mg or 200 mg).
Croatian: Lijek Voriconazole Accord dostupan je u obliku tableta (50 ili 200 mg).
English: It works by preventing the formation of ergosterol, which is an important part of fungal cell membranes.
Croatian: Djeluje tako da sprečava stvaranje ergosterola koji je važan sastavni dio stanične stijenke gljivica.
English: This means that Voriconazole Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Vfend.
Croatian: To znači da je Voriconazole Accord sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Vfend.
English: The aim of the loading dose is to attain effective blood levels quickly.
Croatian: Udarna se doza daje radi brzog postizanja učinkovitih razina koncentracije u krvi.
English: • invasive aspergillosis (a type of fungal infection due to Aspergillus);
Croatian: • invazivnom aspergilozom (vrstom gljivične infekcije uzrokovane gljivicom Aspergillus);
English: The loading dose is then followed by a maintenance dose that can be adjusted according to the patient's response.
Croatian: Nakon udarne doze daje se doza održavanja koja se može prilagoditi sukladno tome kako bolesnik podnosi lijek.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Voriconazole Accord has been shown to have comparable quality and to be bioequivalent to Vfend.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno da Voriconazole Accord posjeduje usporedivu kvalitetu te je bioekvivalentan s lijekom Vfend.
English: • serious fungal infections caused by Scedosporium or Fusarium (two different types of fungus).
Croatian: • teškim gljivičnim infekcijama uzrokovanima vrstama iz rodova Scedosporium ili Fusarium (dvije različite vrste gljivica).