FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials with empagliflozin, the overall frequency of volume depletion (including the predefined terms blood pressure (ambulatory) decreased, blood pressure systolic decreased, dehydration, hypotension, hypovolaemia, orthostatic hypotension, and syncope) was similar in patients treated with empagliflozin (empagliflozin 10 mg: 0.6 %, empagliflozin 25 mg: 0.4 %) and placebo (0.3 %).
Slovenian: V kliničnih preskušanjih z empagliflozinom je bila skupna pogostnost zmanjšanja volumna (vključno s predhodno opredeljenimi pojmi znižanje krvnega tlaka (ambulantno), znižanje sistoličnega krvnega tlaka, dehidracija, hipotenzija, hipovolemija, ortostatska hipotenzija in sinkopa) podobna pri bolnikih,
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)
Slovenian: Glyxambi 25 mg/5 mg filmsko obložene tablete EU/1/16/1146/010 (7 x 1 filmsko obložena tableta) EU/1/16/1146/011 (10 x 1 filmsko obložena tableta) EU/1/16/1146/012 (14 x 1 filmsko obložena tableta) EU/1/16/1146/013 (28 x 1 filmsko obložena tableta) EU/1/16/1146/014 (30 x 1 filmsko obložena tableta) EU/1/16/1146/015 (60 x 1 filmsko obložena tableta) EU/1/16/1146/016 (70 x 1 filmsko obložena tableta) EU/1/16/1146/017 (90 x 1 filmsko obložena tableta) EU/1/16/1146/018 (100 x 1 filmsko obložena tableta)
English: General toxicity studies in rats up to 13 weeks were performed with the combination of empagliflozin and linagliptin.
Slovenian: S kombinacijo empagliflozina in linagliptina so izvedli splošne študije toksičnosti, ki so trajale do 13 tednov.
English: • increased pancreas enzyme lipase
Slovenian: • zvišana raven encima lipaze iz trebušne slinavke,
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
Slovenian: EU/1/16/1146/010 7 x 1 filmsko obložena tableta EU/1/16/1146/011 10 x 1 filmsko obložena tableta EU/1/16/1146/012 14 x 1 filmsko obložena tableta EU/1/16/1146/013 28 x 1 filmsko obložena tableta EU/1/16/1146/014 30 x 1 filmsko obložena tableta EU/1/16/1146/015 60 x 1 filmsko obložena tableta EU/1/16/1146/016 70 x 1 filmsko obložena tableta EU/1/16/1146/017 90 x 1 filmsko obložena tableta EU/1/16/1146/018 100 x 1 filmsko 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
Slovenian: EU/1/16/1146/001 7 x 1 filmsko obložena tableta EU/1/16/1146/002 10 x 1 filmsko obložena tableta EU/1/16/1146/003 14 x 1 filmsko obložena tableta EU/1/16/1146/004 28 x 1 filmsko obložena tableta EU/1/16/1146/005 30 x 1 filmsko obložena tableta EU/1/16/1146/006 60 x 1 filmsko obložena tableta EU/1/16/1146/007 70 x 1 filmsko obložena tableta EU/1/16/1146/008 90 x 1 filmsko obložena tableta EU/1/16/1146/009 100 x 1 filmsko obložena tableta
English: • skin rash
Slovenian: • moten urin,
English: Your blood sugar levels may increase when you stop taking Glyxambi.
Slovenian: Če boste zdravilo Glyxambi prenehali jemati, se bodo ravni krvnega sladkorja morda povišale.
English: Name and address of the manufacturer responsible for batch release Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 173
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij Boehringer Ingelheim Pharma GmbH & Co.
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)
Slovenian: Glyxambi 10 mg/5 mg filmsko obložene tablete EU/1/16/1146/001 (7 x 1 filmsko obložena tableta) EU/1/16/1146/002 (10 x 1 filmsko obložena tableta) EU/1/16/1146/003 (14 x 1 filmsko obložena tableta) EU/1/16/1146/004 (28 x 1 filmsko obložena tableta) EU/1/16/1146/005 (30 x 1 filmsko obložena tableta) EU/1/16/1146/006 (60 x 1 filmsko obložena tableta) EU/1/16/1146/007 (70 x 1 filmsko obložena tableta) EU/1/16/1146/008 (90 x 1 filmsko obložena tableta) EU/1/16/1146/009 (100 x 1 filmsko obložena tableta)
English: STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 25 mg empagliflozin and 5 mg linagliptin.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 25 mg empagliflozina in 5 mg linagliptina.
English: In male rats, treatment related benign vascular proliferative lesions (haemangiomas) of the mesenteric lymph node were observed at the highest dose, but not at 300 mg/kg/day, which corresponds to approximately 26 times the maximal clinical exposure to empagliflozin.
Slovenian: Pri podganjih samcih so pri največjih odmerkih, ne pa tudi pri 300 mg/kg/dan, kar ustreza približno 26-kratni največji klinični izpostavljenosti empagliflozinu, opazili z zdravilom povezane benigne vaskularne proliferativne lezije (hemangiome) mezentrialnih bezgavk.
English: Pancreatitis Mouth ulceration
Slovenian: Bulozni pemfigoid
English: , urticaria
Slovenian: Jetrna okvara
English: Systemic exposure of empagliflozin increased in a dose proportional manner.
Slovenian: Izpostavljenost empagliflozinu je pri bolnikih s hudo jetrno okvaro povečana.
English: STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 10 mg empagliflozin and 5 mg linagliptin.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 10 mg empagliflozina in 5 mg linagliptina.
English: Patients randomized to the linagliptin 5 mg group were receiving either fixed dose combination tablets Glyxambi 10 mg/5 mg plus metformin or fixed dose combination tablets Glyxambi 25 mg/5 mg plus metformin; patients randomized to the placebo group were receiving placebo plus empagliflozin 10 mg plus metformin or placebo plus empagliflozin 25 mg plus metformin MMRM model on FAS (OC) includes baseline HbA1c, baseline eGFR (MDRD), geographical region, visit, treatment, and treatment by visit interaction.
Slovenian: Bolniki, ki so bili randomizirani v skupino z linagliptinom 5 mg, so prejemali tablete Glyxambi s fiksno kombinacijo 10 mg/5 mg in metformin ali tablete Glyxambi s fiksno kombinacijo 25 mg/5 mg in metformin.
English: • In patients with an eGFR <60 mL/min/1.73 m 2 or CrCl <60 mL/min, Glyxambi should not be initiated.
Slovenian: • Zdravila Glyxambi se ne sme uvesti pri bolnikih z eGFR < 60 ml/min/1,73 m 2 ali
English: Haematocrit increased Serum lipids increased Blood creatinine increased/Glomerular filtration rate decreased derived from empagliflozin experiences derived from linagliptin experiences derived from linagliptin postmarketing experience derived from empagliflozin postmarketing experience Mean changes from baseline in haematocrit were 3.3% and 4.2% for Glyxambi 10 mg/5 mg and 25 mg/5 mg, respectively, compared to 0.2% for placebo.
Slovenian: Preiskave pogosti pogosti občasni občasni občasni zvišana raven amilaze zvišana raven lipaze zvišana raven hematokrita zvišana raven lipidov v serumu zvišana raven kreatinina v krvi/zmanjšana hitrost glomerularne filtracije izhaja iz izkušenj z empagliflozinom izhaja iz izkušenj z linagliptinom izhaja iz izkušenj z linagliptinom v obdobju trženja izhaja iz izkušenj z empagliflozinom v obdobju trženja
English: NAME OF THE MEDICINAL PRODUCT Glyxambi 10 mg/5 mg film-coated tablets empagliflozin/linagliptin
Slovenian: Glyxambi 10 mg/5 mg filmsko obložene tablete empagliflozin/linagliptin
English: Cardiac failure
Slovenian: Ledvična okvara
English: Liver, kidneys, stomach, reproductive organs, thymus, spleen, and lymph nodes were target organs of toxicity in Cynomolgus monkeys at more than 450-times the clinical exposure.
Slovenian: Pri opicah vrste Cynomolgus so bili pri izpostavljenosti, ki je bila več kot 450-krat večja od klinične izpostavljenosti, ciljni organi za toksične učinke jetra, ledvice, želodec, reproduktivni organi, priželjc, vranica in bezgavke.
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.
Slovenian: Ni znano, ali zdravilo Glyxambi škoduje nerojenemu otroku.
English: NAME OF THE MEDICINAL PRODUCT Glyxambi 25 mg/5 mg film-coated tablets empagliflozin/linagliptin
Slovenian: Glyxambi 25 mg/5 mg filmsko obložene tablete empagliflozin/linagliptin
English: Talk to your doctor if you have kidney problems.
Slovenian: Če imate težave z ledvicami, se pogovorite z zdravnikom.
English: All-cause mortality N (%) Hazard ratio vs. placebo (95% CI) p-value
Slovenian: razmerje tveganja v primerjavi s placebom (95 % IZ) vrednost p kap brez smrtnega izida N (%) razmerje tveganja v primerjavi s placebom (95 % IZ) vrednost p smrtnost zaradi vseh razlogov N (%) razmerje tveganja v primerjavi s placebom (95 % IZ) vrednost p umrljivost, ki ni srčno-žilnega izvora N
English: 100 ml vial
Slovenian: Škatla z 10 odmerki, 20 ml steklenička
English: Packaging Content Package size
Slovenian: Vsebina Vsebina vsebnika
English: EU Number Tradename Strength
Slovenian: EU evidenčna št. Zaščiteno ime
English: Zero days
Slovenian: Karenca
English: Route of administration
Slovenian: Načina dajanja Pakiranje
English: Date of first authorisation: 24 November 2011 Date of latest renewal: 8 August 2016
Slovenian: Datum prve odobritve: 24. november 2011 Datum zadnjega podaljšanja: 8. avgust 2016
English: Desloratadine is moderately bound (83 % - 87 %) to plasma proteins.
Slovenian: Desloratadin se zmerno (83 % - 87 %) veže na plazemske beljakovine.
English: Adults and adolescents 12 years of age and over
Slovenian: Odrasli in mladostniki, stari 12 let in več
English: The recommended dose is one tablet once a day with water, with or without food.
Slovenian: Priporočeni odmerek je ena tableta, enkrat na dan z vodo, s hrano ali brez nje.
English: It also contains lactose monohydrate.
Slovenian: Vsebuje tudi laktozo monohidrat.
English: • if you are allergic to desloratadine, or any of the other ingredients of this medicine (listed in section 6) or to loratadine.
Slovenian: • če ste alergični na desloratadin ali katero koli sestavino tega zdravila (navedeno v poglavju 6) ali na loratadin.
English: Packs of 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 90, 100 and 105 film-coated tablets.
Slovenian: Pakiranja po 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 90, 100 ali 105 filmsko obloženih tablet.
English: Paediatric population Interaction studies have only been performed in adults.
Slovenian: Študije medsebojnega delovanja so bile izvedene samo pri odraslih.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Slovenian: V natisnjenem navodilu za uporabo morata biti navedena ime in naslov izdelovalca odgovornega za sprostitev zadevne serije.
English: Not known: frequency cannot be estimated from the available data
Slovenian: Otroci Neznana: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti
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.
Slovenian: Kar zadeva trajanje zdravljenja, bo vaš zdravnik najprej ugotovil vrsto alergijskega rinitisa, ki jo imate, in na podlagi tega določil, kako dolgo naj bi jemali zdravilo Desloratadin Teva.
English: In the event of overdose, consider standard measures to remove unabsorbed active substance.
Slovenian: Zdravljenje V primeru prevelikega odmerjanja zdravila upoštevajte standardne ukrepe za odstranjevanje neabsorbirane učinkovine iz telesa.
English: Each film-coated tablet contains 1.2 mg of lactose monohydrate (see section 4.4).
Slovenian: Ena filmsko obložena tableta vsebuje 1,2 mg laktoze monohidrata (glejte poglavje 4.4).
English: EU/1/11/732/001 EU/1/11/732/002 EU/1/11/732/003 EU/1/11/732/004 EU/1/11/732/005 EU/1/11/732/006 EU/1/11/732/007 EU/1/11/732/008 EU/1/11/732/009 EU/1/11/732/010 EU/1/11/732/011 EU/1/11/732/012 EU/1/11/732/013 EU/1/11/732/014
Slovenian: EU/1/11/732/001 EU/1/11/732/002 EU/1/11/732/003 EU/1/11/732/004 EU/1/11/732/005 EU/1/11/732/006 EU/1/11/732/007 EU/1/11/732/008 EU/1/11/732/009
English: Taking Desloratadine Teva is not recommended if you are pregnant or nursing a baby.
Slovenian: Jemanje zdravila Desloratadin Teva vam ne priporočamo, če ste noseči ali če dojite.
English: If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule.
Slovenian: Če ste pozabili vzeti zdravilo Desloratadin Teva Če ste pozabili vzeti odmerek pravočasno, ga vzemite čimprej, potem pa nadaljujte z ustaljenim režimom odmerjanja.
English: At the recommended dose, this medicine is not expected to affect your ability to drive or use machines.
Slovenian: Ni pričakovati, da bi to zdravilo v priporočenem odmerku vplivalo na vašo sposobnost za vožnjo ali upravljanje strojev.
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.
Slovenian: Varnost in učinkovitost zdravila Desloratadin Teva 5 mg filmsko obložene tablete pri otrocih, mlajših od 12 let, nista bili dokazani.
English: Desloratadine Teva with food, drink and alcohol
Slovenian: Zdravilo Desloratadin Tevaskupaj s hrano, in pijačo in alkoholom
English: Desloratadine Teva 5 mg
Slovenian: Desloratadin Teva 5 mg
English: There are no known interactions of Desloratadine Teva with other medicines.
Slovenian: Ni znanih interakcij med zdravilom Desloratadin Teva in drugimi zdravili.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se posvetujte z njim pred jemanjem tega zdravila.
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).
Slovenian: Zdravilo Desloratadin Teva 5 mg filmsko obložene tablete je na voljo v pretisnih omotih po 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 90, 100 ali 105 filmsko obloženih tablet in perforiranih pretisnih omotih po 50 x 1 filmsko obložena tableta (enoodmerni pretisni omot).
English: Adverse reactions seen with desloratadine
Slovenian: Neželeni učinki opaženi pri desloratidinu
English: In the case of severe renal insufficiency, Desloratadine Teva 5 mg film-coated tablets should be used with caution (see section 5.2).
Slovenian: V primeru hude ledvične insuficience morate zdravilo Desloratadin Teva 5 mg filmsko obložene tablete uporabljati previdno (glejte poglavje 5.2).
English: Desloratadine plasma concentrations can be detected within 30 minutes of administration.
Slovenian: Absorpcija Plazemsko koncentracijo desloratadina lahko zaznamo že v 30 minutah po uporabi zdravila.
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.
Slovenian: - Druge sestavine zdravila so mikrokristalna celuloza, predgelirani koruzni škrob, smukec, koloidni brezvodni slicijev dioksid, laktoza monohidrat, hipromeloza, titanov dioksid (E171), makrogol 400, indigotin (E132), šelak in propilenglikol.
English: What you need to know before you take Desloratadine Teva Do not take Desloratadine Teva
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Desloratadin Teva Ne jemljite zdravila Desloratadin Teva
English: Contents of the pack and other information What Desloratadine Teva contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje Desloratadin Teva
English: In another study, grapefruit juice had no effect on the disposition of desloratadine.
Slovenian: drugi študiji so ugotavljali, da tudi sok grenivke ne vpliva na porazdelitev desloratadina.
English: Desloratadine Teva may be taken with or without a meal.
Slovenian: Zdravilo Desloratadin Teva se lahko jemlje s hrano ali brez nje.
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)
Slovenian: Zdravilo Desloratadin Teva je indiciran pri odraslih in mladostnikih, starih 12 let in več, za lajšanje simptomov: - alergijskega rinitisa (glejte poglavje 5.1) - urtikarije (glejte poglavje 5.1)
English: OPA/Alu/PVC - Aluminium blisters.
Slovenian: OPA/Alu/PVC - aluminijasti pretisni omoti.
English: Merckle GmbH Ludwig-Merckle-Strasse 3 D-89143 Blaubeuren Germany
Slovenian: Merckle GmbH Ludwig-Merckle-Strasse 3 D-89143 Blaubeuren
English: Other medicines and Desloratadine Teva
Slovenian: Druga zdravila in zdravilo Desloratadin Teva
English: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom or
Slovenian: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, Velika Britanija ali
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.
Slovenian: V kliničnih preskušanjih pri različnih indikacijah za uporabo zdravila, vključno z alergijskim rinitisom in kronično idiopatsko urtikarijo so pri priporočenem odmerku 5 mg desloratadina na dan o neželenih učinkih poročali pri 3 % bolnikov več kot pri tistih, ki so bili zdravljeni s placebom.
English: In each trial, the effects were sustained over the 24 hour dosing interval.
Slovenian: V vsakem preskušanju so učinki zdravila trajali ves čas 24
English: Desloratadine Teva is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Slovenian: Zdravilo Desloratadin Teva se uporablja tudi za lajšanje simptomov urtikarije, (težave s kožo zaradi alergije).
English: Adults During the marketing of Desloratadine Teva, the following side effects were reported as:
Slovenian: Med trženjem zdravila Desloratadin Teva so poročali o naslednjih neželenih učinkih:
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.
Slovenian: Zdravilo Desloratadin Teva lajša simptome alergijskega rinitisa (vnetje nosnih poti zaradi alergije, na primer seneni nahod ali alergija na pršice) pri odraslih in mladostnikih, starih 12 let in več.
English: The dose can be taken with or without food.
Slovenian: Način uporabe peroralna uporaba Odmerek se lahko vzame s hrano ali brez nje.
English: Marketing Authorisation Holder Teva B.V.
Slovenian: Imetnik dovoljenja za promet z zdravilom Teva B.V.
English: Pack of 50 x 1 film-coated tablet (unit dose).
Slovenian: Pakiranje 50 x 1 filmsko obložena tableta (enoodmerni pretisni omot).
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
Slovenian: ● povečana občutljivost kože za sonce, tudi če gre za indirektno izpostavljenost soncu (čez oblake, meglo) in UV (ultravijolično) svetlobo, na primer UV svetlobo v solariju.
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.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Desloratadin Teva, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: 50 x 1 film-coated tablet (unit dose) 60 film-coated tablets
Slovenian: 50 x 1 filmsko obložena tableta (enoodmerni pretisni omot) 60 filmsko obloženih tablet
English: Desloratadine Teva contains desloratadine which is an antihistamine.
Slovenian: Zdravilo Desloratadin Teva vsebuje zdravilno učinkovino desloratadin, ki je antihistaminik.
English: Blue, round, biconvex film-coated tablet - printed in with ink: “D5” on one side and plain on the other.
Slovenian: Modre, okrogle, bikonveksne filmsko obložene tablete - z natisnjeno oznako “D5” na eni strani in brez oznake na drugi.
English: How to store Desloratadine Teva Contents of the pack and other information
Slovenian: Shranjevanje zdravila Desloratadin Teva Vsebina pakiranja in dodatne informacije
English: What Desloratadine Teva is and what it is used for What Desloratadine Teva is
Slovenian: Kaj je zdravilo Desloratadin Teva in za kaj ga uporabljamo Kaj je zdravilo Desloratadin Teva
English: What Desloratadine Teva is and what it is used for What you need to know before you take Desloratadine Teva How to take Desloratadine Teva Possible side effects
Slovenian: Kaj je zdravilo Desloratadin Teva in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Desloratadin Teva Kako jemati zdravilo Desloratadin Teva
English: The most frequent of adverse reactions reported in excess of placebo were fatigue (1.2 %), dry mouth (0.8 %) and headache (0.6 %).
Slovenian: Najpogostejši neželeni učinki, katerih pogostnost je bila večja kot pri placebu, so bili utrujenost (1,2 %), suha usta
English: Titanium dioxide (E171) Propylene glycol
Slovenian: Tiskarsko barvilo šelak titanov dioksid (E171) propilenglikol
English: OPA/Alu/PVC - Aluminium perforated unit dose blisters.
Slovenian: OPA/Alu/PVC - perforirani pretisni omoti za enkratni odmerek.
English: Desloratadine Teva is an antiallergy medicine that does not make you drowsy.
Slovenian: Zdravilo Desloratadin Teva je zdravilo proti alergiji, ki ne povzroča zaspanosti.
English: Tablet coating Lactose monohydrate Hypromellose Titanium dioxide (E171) Macrogol 400
Slovenian: Obloga tablete laktoza monohidrat hipromeloza titanov dioksid (E171) makrogol 400 indigotin (E132)
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).
Slovenian: V klinični farmakološki raziskavi pri sočasnem jemanju tablet desloratadina in uživanju alkohola ni bilo okrepljenih škodljivih učinkov alkohola (glejte poglavje 5.1).
English: Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren Germany
Slovenian: Merckle GmbH Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren
English: EU/1/11/732/013 50 x 1 film-coated tablet (unit dose) EU/1/11/732/014 105 film-coated tablets
Slovenian: EU/1/11/732/013 50 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/11/732/014 105 filmsko obloženih tablet
English: As a precautionary measure, it is preferable to avoid the use of Desloratadine Teva 5 mg film-coated tablets during pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Desloratadin Teva 5 mg filmsko obložene tablete bolje izogibati.