FrancophonIA/ELRC3.0 huggingface dataset:
English: Cholestagel resulted in a statistically significant LDL-C reduction of 11% and 11% at 6 and 12 weeks vs an increase of 7% and 1% in the placebo group; mean baseline levels were 3.75 mmol/L and 3.86 mmol/L, respectively.
Slovenian: Zdravilo Cholestagel je povzročilo statistično pomembno znižanje koncentracije holesterola LDL za 11 % po 6 tednih in 11 % po 12 tednih iz povprečne izhodiščne koncentracije 3,75 mmol/L, v placebo skupini pa se je koncentracija holesterola LDL po 6 tednih zvišala za 7 %, po 12 tednih pa za 1 % iz povprečne izhodiščne koncentracije 3,86 mmol/L.
English: Marketing authorisation holder Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, the Netherlands
Slovenian: Imetnik dovoljenja za promet z zdravilom Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Nizozemska
English: Co-administration of colesevelam and glipizide decreases the exposure of glipizide.
Slovenian: Sočasno jemanje holesevelama in glipizida zmanjša izpostavljenost glipizidu.
English: In an interaction study in healthy volunteers, Cholestagel reduced the AUC and Cmax of levothyroxine when administered either concomitantly or after 1 hour.
Slovenian: V študiji o medsebojnem delovanju pri zdravih prostovoljcih je zdravilo Cholestagel znižalo vrednosti AUC in Cmax levotiroksina tako ob sočasnem jemanju kot po 1 uri.
English: The location of such potential obstruction, the degree of obstruction and the presence or absence of normal gut motility would determine treatment.
Slovenian: Zdravljenje bi bilo odvisno od mesta in stopnje obstrukcije ter normalne ali nenormalne gibljivosti prebavil.
English: Anticoagulant therapy should be monitored closely in patients receiving warfarin or similar agents, since bile acid sequestrants, like Cholestagel, have been shown to reduce absorption of vitamin K and therefore interfere with warfarin's anticoagulant effect (see also section 4.5).
Slovenian: Pri bolnikih, ki prejemajo varfarin ali podobne učinkovine, morate zdravljenje z antikoagulanti pozorno spremljati, kajti adsorbenti žolčnih kislin, kot je zdravilo Cholestagel, zmanjšujejo absorpcijo vitamina K in tako ovirajo antikoagulantni učinek varfarina (glejte tudi poglavje 4.5).
English: For all patients, Cholestagel resulted in a statistically significant LDL-C reduction of 11% at 3.8 g/day and 4% at 1.9 g/day, versus a 3% increase in the placebo group.
Slovenian: Pri vseh bolnikih se je po zdravljenju z zdravilom Cholestagel statistično pomembno znižala koncentracija holesterola LDL, in sicer za 11 % v skupini, ki je prejemala odmerek 3,8 g/dan, in za 4 % v skupini, ki je prejemala odmerek 1,9 g/dan, v placebo skupini pa se je koncentracija zvišala za 3 %.
English: Your doctor may tell you to take the Cholestagel dose either once a day or twice a day; in either case Cholestagel should be taken with a meal.
Slovenian: Zdravnik vam bo morda dejal, da vzamete odmerek zdravila Cholestagel bodisi enkrat ali dvakrat dnevno.
English: What Cholestagel contains
Slovenian: Kaj vsebuje zdravilo Cholestagel
English: Cholestagel 625 mg film-coated tablets Colesevelam
Slovenian: Cholestagel 625 mg filmsko obložene tablete holesevelam
English: Patients starting on ciclosporin already taking Cholestagel should have their ciclosporin blood concentrations monitored as normal and their dose adjusted as normal.
Slovenian: Bolniki, ki že jemljejo zdravilo Cholestagel in bodo hkrati začeli jemati ciklosporin, morajo imeti kontrolne izmerjene vrednosti ciklosporina v krvi normalne in odmerek ciklosporina prilagojen normalni vrednosti.
English: As noted in general, when a drug interaction cannot be excluded with a concomitant medicinal product, Cholestagel should be administered at least four hours before or at least four hours after the concomitant medication to minimise the risk of reduced absorption of the concomitant medication.
Slovenian: Na splošno velja, da je potrebno v primeru, kadar ne morete izključiti medsebojnega delovanja s sočasno uporabljenim zdravilom, zdravilo Cholestagel vzeti vsaj štiri ure pred ali vsaj štiri ure po sočasno uporabljenem zdravilu, da bi zmanjšali tveganje zmanjšane absorpcije sočasno uporabljenega zdravila.
English: Cholestagel contains the active substance colesevelam (as hydrochloride).
Slovenian: Zdravilo Cholestagel vsebuje učinkovino holesevelam (v obliki holesevelamijevega klorida).
English: Cholestagel has not been compared directly to other bile acid sequestrants in clinical trials.
Slovenian: V kliničnih preskušanjih niso neposredno primerjali zdravila Cholestagel z drugimi adsorbenti žolčnih kislin.
English: The maximum recommended dose is 6 tablets per day taken as 3 tablets twice per day with meals or 6 tablets taken once per day with a meal.
Slovenian: Najvišji priporočeni odmerek je 6 tablet dnevno, ki se vzamejo kot 3 tablete dvakrat dnevno, ob obrokih, ali 6 tablet enkrat dnevno, ob obroku.
English: - The active substance is colesevelam (as hydrochloride).
Slovenian: - Zdravilna učinkovina je holesevelam (v obliki holesevelamijevega klorida).
English: For statin-naïve patients on monotherapy, Cholestagel resulted in a statistically significant LDL-C reduction of 12% at 3.8 g/day and 7% at 1.9 g/day, versus a 1% reduction in the placebo group (see section 4.2).
Slovenian: Pri bolnikih, ki se še niso zdravili s statini v obliki monoterapije, se je po zdravljenju z zdravilom Cholestagel statistično pomembno znižala koncentracija holesterola LDL, in sicer za 12 % v skupini, ki je prejemala odmerek 3,8 g/dan, in za 7 % v skupini, ki je prejemala odmerek 1,9 g/dan, v placebo skupini pa se je koncentracija znižala za 1 % (glejte poglavje 4.2).
English: Co-administration of colesevelam and olmesartan decreases the exposure of olmesartan.
Slovenian: Sočasno jemanje holesevelama in olmesartana zmanjša izpostavljenost olmesartanu.
English: The background incidence of flatulence and diarrhoea were higher in patients receiving placebo in the same controlled clinical studies.
Slovenian: V istih nadziranih kliničnih študijah so opazili večjo pogostost pojavljanja flatulence in diareje pri bolnikih, ki so prejemali placebo.
English: Anticoagulant therapy should be monitored closely in patients receiving warfarin or similar agents, since bile acid sequestrants, like Cholestagel, have been shown to reduce absorption of vitamin K and therefore interfere with warfarin's anticoagulant effect.
Slovenian: Pri bolnikih, ki prejemajo varfarin ali podobna zdravila, morate zdravljenje z antikoagulanti pozorno spremljati, kajti adsorbenti žolčnih kislin, kot je zdravilo Cholestagel, zmanjšujejo absorpcijo vitamina K in tako ovirajo antikoagulatni učinek varfarina.
English: Patients starting on Cholestagel already taking ciclosporin should have their blood concentrations monitored prior to combination therapy and frequently monitored immediately starting co-therapy with the ciclosporin dose adjusted accordingly.
Slovenian: Pri bolnikih, ki že jemljejo ciklosporin in bodo hkrati začeli jemati tudi zdravilo Cholestagel, se morajo izvajati kontrolne meritve vrednosti v krvi pred kombiniranim zdravljenjem in nato pogosto takoj po začetku kombiniranega zdravljenja s ciklosporinom; odmerek ciklosporina mora biti ustrezno prilagojen.
English: Therefore when a drug interaction cannot be excluded with a concomitant medicinal product for which minor variations in the therapeutic level would be clinically important, Cholestagel should be administered at least four hours before or at least four hours after the concomitant medication to minimize the risk of reduced absorption of the concomitant medication.
Slovenian: Kadar ne morete izključiti medsebojnega delovanja s sočasno uporabljenim zdravilom, pri katerem bi lahko bile manjše spremembe pri zdravljenju klinično pomembne, je potrebno zdravilo Cholestagel vzeti najmanj štiri ure pred ali najmanj štiri ure po sočasno uporabljenem zdravilu, da bi zmanjšali tveganje za zmanjšano absorpcijo sočasno uporabljenega zdravila.
English: Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam The Netherlands
Slovenian: Paasheuvelweg 25, 1105 BP Amsterdam Nizozemska
English: Therefore, patients taking both ciclosporin and Cholestagel should have their blood concentrations monitored prior to and frequently after when Cholestagel therapy is stopped with their ciclosporin dose adjusted accordingly.
Slovenian: Zato je potrebno pri bolnikih, ki hkrati jemljejo ciklosporin in zdravilo Cholestagel, izvajati kontrolne meritve vrednosti v krvi pred zdravljenjem in nato pogosto po prenehanju zdravljenja z zdravilom Cholestagel; odmerek ciklosporina pa mora biti ustrezno prilagojen.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 625 mg of colesevelam (as hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 625 mg holesevelama (v obliki holesevelamijevega klorida).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 10. marec 2004
English: High density polyethylene bottles with a polypropylene cap.
Slovenian: Plastenke iz polietilena visoke gostote s pokrovom iz polipropilena z ali zunanje ovojnine.
English: The recommended starting dose of Cholestagel is 6 tablets per day taken as 3 tablets twice per day with meals or 6 tablets once per day with a meal.
Slovenian: Priporočeni začetni odmerek je 6 tablet dnevno, ki se vzamejo kot 3 tablete dvakrat dnevno, ob obrokih, ali 6 tablet enkrat dnevno, ob obroku.
English: Additionally, if you have any condition that could cause you to have a deficiency of vitamins A, D, E or K, your doctor may want to check your vitamin levels periodically while you are taking Cholestagel.
Slovenian: Poleg tega vam bo med jemanjem zdravila Cholestagel zdravnik morda želel občasno preveriti koncentracije vitaminov, če imate bolezen, ki bi lahko povzročila pomanjkanje vitaminov A, D, E ali K. Če bo potrebno, vam bo svetoval jemanje vitaminskih nadomestkov.
English: Cholestagel in combination with statins and in combination with ezetimibe was well tolerated and the adverse reactions observed were consistent with the known safety profile of statins or ezetimibe alone.
Slovenian: Ugotovljeni neželeni učinki so bili skladni z znanim varnostnim profilom statinov samih oz. ezetimiba samega.
English: Olmesartan should be administered at least 4 hours prior to colesevelam.
Slovenian: Olmesartan je treba vzeti vsaj 4 ure pred zaužitjem holesevelama.
English: No interaction was observed when Cholestagel was administered at least four hours after levothyroxine.
Slovenian: Niso opazili medsebojnega delovanja, če je bilo zdravilo Cholestagel vzeto najmanj štiri ure po levotiroksinu.
English: Glipizide should be administered at least 4 hours prior to colesevelam.
Slovenian: Glipizid je potrebno vzeti vsaj 4 ure pred zaužitjem holesevelama.
English: Levothyroxine
Slovenian: Levotiroksin
English: As described in Section 2, if you will be taking Cholestagel along with another medicine it is possible that your doctor will advise you to take Cholestagel at least 4 hours before or at least 4 hours after taking the other medicine.
Slovenian: Če boste med zdravljenjem z zdravilom Cholestagel jemali drugo zdravilo, vam bo morda zdravnik svetoval, da zdravilo Cholestagel vzamete najmanj 4 ure pred ali najmanj 4 ure po tem, ko ste vzeli druga zdravila, kot je opisano v poglavju 2.
English: The recommended dose for Cholestagel is 3 tablets taken twice a day with meals or 6 tablets a day with a meal.
Slovenian: Priporočeni odmerek zdravila Cholestagel je 3 tablete dvakrat dnevno, ob obroku, ali 6 tablet enkrat dnevno, ob obroku.
English: This interaction was also observed when Cholestagel was administered one hour after the oral contraceptive pill.
Slovenian: Tako medsebojno delovanje so opazili tudi, če je bilo zdravilo Cholestagel vzeto eno uro po peroralni kontracepcijski tabletki, vendar pa niso opazili medsebojnega delovanja, če je bilo zdravilo Cholestagel vzeto štiri ure po peroralni kontracepcijski tabletki.
English: The effect of 3.8 g Cholestagel plus 10 mg ezetimibe versus 10 mg ezetimibe alone on LDL-C levels was assessed in a multicentre, randomised, double-blind, placebo-controlled, parallel-group study in 86 patients with primary hypercholesterolaemia over a 6-week treatment period.
Slovenian: V multicentrični, randomizirani, dvojno slepi, s placebom kontrolirani študiji vzporednih skupin s 86 bolniki s primarno hiperholesterolemijo so v 6 tednih zdravljenja ocenjevali učinek kombinacije 3,8 g zdravila Cholestagel in 10 mg ezetimiba v primerjavi z 10 mg ezetimiba samega na koncentracijo holesterola LDL.
English: There were no significant effects on growth, sexual maturation, fat-soluble vitamin levels or clotting factors, and the adverse reaction profile for Cholestagel was comparable to that seen with placebo.
Slovenian: Ni bilo pomembnih učinkov na rast, spolno dozorevanje, koncentracijo v maščobi topnih vitaminov ali faktorjev strjevanja krvi.
English: Therefore glimepiride should be administered at least 4 hours prior to colesevelam.
Slovenian: Zato je potrebno glimepirid vzeti vsaj 4 ure pred zaužitjem holesevelama.
English: Cholestagel had no effect on the bioavailability of lovastatin in an interaction study.
Slovenian: V študiji interakcije so ugotovili, da zdravilo Cholestagel ni imelo učinka na biološko razpoložljivost lovastatina.
English: Cholesterol is the sole precursor of bile acids.
Slovenian: Edini prekurzor žolčnih kislin je holesterol.
English: Constipation or bloating could occur.
Slovenian: Lahko se pojavijo prebavne motnje.
English: Anticoagulant therapy
Slovenian: Zdravljenje z antikoagulanti
English: No interaction was observed when Cholestagel was administered four hours after glyburide.
Slovenian: Niso opazili medsebojnega delovanja, če je bilo zdravilo Cholestagel vzeto najmanj štiri ure po gliburidu.
English: Package sizes are: 24 tablets (1 X 24)
Slovenian: Velikosti pakiranj: 24 tablet (1 x 24) 100 tablet (2 x 50) 180 tablet (1 x 180)
English: Colesevelam is a non-absorbed, lipid-lowering polymer that binds bile acids in the intestine, impeding their reabsorption.
Slovenian: Holesevelam je polimer, ki se ne absorbira in znižuje koncentracije lipidov.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/268/001-004
Slovenian: EU/1/03/268/001 - 24 tablet EU/1/03/268/002 - 100 tablet EU/1/03/268/003 - 180 tablet v škatli EU/1/03/268/004 - 180 tablet brez škatle
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: For patients on ciclosporin starting or stopping Cholestagel or patients on Cholestagel with a need to start ciclosporin: Cholestagel reduces the bioavailability of ciclosporin (see also section 4.5).
Slovenian: Za bolnike, ki jemljejo ciklosporin in bodo začeli jemati ali prenehali jemati zdravilo Cholestagel, ali za bolnike, ki jemljejo zdravilo Cholestagel in morajo začeti jemati tudi ciklosporin:
English: Cholestagel predominantly binds hydrophobic bile acids.
Slovenian: Zdravilo Cholestagel veže pretežno hidrofobne žolčne kisline.
English: Common (may affect up to 1 in 10 people): vomiting, diarrhoea, indigestion, abdominal pain, abnormal stools, feeling sick, bloating, headache, raised levels of triglycerides (fats) in your blood.
Slovenian: Pri bolnikih, ki so jemali zdravilo Cholestagel, so poročali o naslednjih neželenih učinkih: zelo pogosto (pojavijo se lahko pri več kot 1 od 10 bolnikov): flatulenca (vetrovi), zapeka; pogosto (pojavijo se lahko pri največ 1 od 10 bolnikov); bruhanje, driska, prebavne motnje, bolečine v trebuhu, nenormalno blato, slabost, napenjanje, glavobol, povišane vrednosti trigliceridov (maščob) v krvi; občasno (pojavijo se lahko pri največ 1 od 100 bolnikov): bolečine v mišicah, povišane vrednosti jetrnih encimov v krvi, oteženo požiranje; zelo redko (pojavijo se lahko pri največ 1 od 10.000 bolnikov): vnetje trebušne slinavke; neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov): zapora črevesja (ki je lahko pogostejša med bolniki, za katere je znano, da so imeli v preteklosti zaporo črevesja ali jim je bil odstranjen del črevesja)
English: The addition of Cholestagel 3.8 g daily to maximally-tolerated statin and ezetimibe therapy was assessed in a multi-centre, randomised, double-blind, placebo-controlled study in 86 patients with familial hypercholesterolaemia.
Slovenian: V multicentrični, randomizirani, dvojno slepi, s placebom kontrolirani študiji s 86 bolniki z družinsko hiperholesterolemijo so ocenjevali dodatek 3,8 g zdravila Cholestagel dnevno h kombinaciji statina in ezetimiba, ki so jo bolniki najbolje prenašali.
English: No interaction was observed when Cholestagel was administered one hour after repaglinide.
Slovenian: Niso opazili medsebojnega delovanja, če je bilo zdravilo Cholestagel vzeto najmanj štiri ure po repaglinidu.
English: Check with your doctor or pharmacist if you are unsure.
Slovenian: Če ste negotovi, se posvetujte s svojim zdravnikom ali farmacevtom.
English: EXP
Slovenian: Obstipacija
English: No interaction was observed when glimepiride was taken at least 4 hours before colesevelam.
Slovenian: Ob jemanju glimepirida vsaj 4 ure pred zaužitjem holesevelama medsebojnega delovanja niso opazili.
English: Ελλάδα sanofi-aventis AEBE Τηλ: +30 210 900 16 00
Slovenian: Τηλ: +30 210 900 16 00
English: Date of first authorisation: 15 January 2001 Date of latest renewal: 15 January 2006
Slovenian: Datum prve odobritve: 15. januar 2001 Datum zadnjega podaljšanja: 15. januar 2006
English: Symptomatic and supportive treatment is recommended.
Slovenian: Priporočamo simptomatsko in podporno terapijo.
English: ● yellowing of the skin and/or eyes
Slovenian: ● rumeno obarvanje kože in/ali oči
English: The clinical relevance of these observations remains to be confirmed.
Slovenian: Klinični pomen teh izsledkov še ni potrjen.
English: Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep.
Slovenian: Ublažitev teh simptomov traja ves dan in vam bo pomagala, da boste lahko spet opravljali običajne vsakdanje dejavnosti in spali.
English: ● severe allergic reactions
Slovenian: ● hude alergijske reakcije
English: Desloratadine is moderately bound (83 % - 87 %) to plasma proteins.
Slovenian: Desloratadin se zmerno (83-87 %) veže na plazemske beljakovine.
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) and not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
English: It helps control your allergic reaction and its symptoms.
Slovenian: Pomagalo vam bo lajšati alergijske reakcije in njihove simptome.
English: Patients should be informed that most people do not experience drowsiness.
Slovenian: Bolnikom morate povedati, da večina ljudi ne postane zaspanih.
English: Swallow the dose of oral solution and then drink some water.
Slovenian: Pogoltnite odmerek peroralne raztopine in potem popijte malo vode.
English: Adults and adolescents (12 years of age and over)
Slovenian: Odrasli in mladostniki (stari 12 let ali več)
English: This percentage may vary according to ethnic background.
Slovenian: Ta odstotek se lahko razlikuje v odvisnosti od narodnosti bolnikov.
English: In children below 2 years of age, the diagnosis of allergic rhinitis is particularly difficult to distinguish from other forms of rhinitis.
Slovenian: Pri otrocih, mlajših od 2 let, je diagnozo alergijski rinitis še posebej težko razlikovati od drugih oblik rinitisa.
English: Desloratadine does not readily penetrate the central nervous system.
Slovenian: Desloratadin ne prehaja zlahka v osrednji živčni sistem.
English: If you notice any of these serious side effects, stop taking the medicine and seek urgent medical advice straight away.
Slovenian: Če opazite katerega koli od teh resnih neželenih učinkov, nemudoma prenehajte jemati zdravilo in poiščite nujno zdravniško pomoč.
English: Paediatric population Interaction studies have only been performed in adults.
Slovenian: Pediatrična populacija Študije medsebojnega delovanja so bile izvedene samo pri odraslih.
English: There are no known interactions of Aerius with other medicines.
Slovenian: Ni znanih interakcij med zdravilom Aerius in drugimi zdravili.
English: Manufacturer: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.
Slovenian: Izdelovalec: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgija.
English: Contains mannitol and aspartame.
Slovenian: Vsebuje manitol in aspartam.
English: Not known: frequency cannot be estimated from the available data ● unusual weakness
Slovenian: Neznana pogostnost: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti ● neobičajna šibkost
English: Treatment with Aerius also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
Slovenian: Zdravljenje z zdravilom Aerius je tudi bistveno zmanjšalo motnje spanja in dnevnih dejavnosti bolnika, kar so ugotavljali na podlagi meritev s štiritočkovno lestvico za oceno teh spremenljivk.
English: In the event of overdose, consider standard measures to remove unabsorbed active substance.
Slovenian: V primeru prevelikega odmerjanja zdravila upoštevajte standardne ukrepe za odstranjevanje neabsorbirane učinkovine iz telesa.
English: ● abnormal behaviour
Slovenian: ● nenormalno vedenje
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Aerius therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Aerius, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformative nor foeto/ neonatal toxicity of desloratadine.
Slovenian: Velika količina podatkov pri nosečnicah (več kot 1.000 izpostavljenih nosečnosti) kaže na odsotnost malformacij, fetotoksičnosti ali neonatalne toksičnosti desloratadina.
English: Other medicines and Aerius
Slovenian: Druga zdravila in zdravilo Aerius
English: Very rare: the following may affect up to 1 in 10,000 people ● severe allergic reactions
Slovenian: Zelo redki: naslednji se lahko pojavijo pri največ 1 od 10.000 bolnikov ● hude alergijske reakcije
English: Desloratadine is the primary active metabolite of loratadine.
Slovenian: Desloratadin je primarni aktivni presnovek loratadina.
English: Desloratadine has been identified in breastfed newborns/infants of treated women.
Slovenian: Desloratadin so ugotovili pri dojenih novorojencih/otrocih zdravljenih žensk.
English: Excipient(s) with known effect: This medicine contains mannitol and aspartame (E951).
Slovenian: Pomožne snovi z znanim učinkom: To zdravilo vsebuje manitol in aspartam (E951).
English: Pharmacotherapeutic group: antihistamines - H1 antagonist, ATC code: R06A X27
Slovenian: Farmakoterapevtska skupina: antihistaminiki za sistemsko zdravljenje - antagonist H1 receptorjev, Oznaka ATC: R06A X27
English: The presence of food prolongs Tmax for desloratadine from 2.5 to 4 hours and Tmax for 3-OHdesloratadine from 4 to 6 hours.
Slovenian: Prisotnost hrane podaljša Tmax desloratadina z 2,5 na 4 ure in Tmax 3-OH-desloratadina s 4 na 6 ur.
English: As a precautionary measure, it is preferable to avoid the use of Aerius during pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Aerius bolje izogibati.
English: Aerius effectively controlled symptoms for 24 hours.
Slovenian: Zdravilo Aerius učinkovito obvladuje te simptome za čas 24 ur.