FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of a high-fat meal with linagliptin prolonged the time to reach Cmax by 2 hours and lowered Cmax by 15 % but no influence on AUC0-72h was observed.
Slovak: Absolútna biologická dostupnosť linagliptínu je približne 30 %. Súbežná konzumácia jedla s vysokým obsahom tuku a linagliptínu predĺžila čas do dosiahnutia Cmax o 2 hodiny a znížila Cmax o 15
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
Slovak: x 1 filmom obalená tableta EU/1/16/1146/005 30 x 1 filmom obalená tableta EU/1/16/1146/006 60 x 1 filmom obalená tableta EU/1/16/1146/007 70 x 1 filmom obalená tableta EU/1/16/1146/008
English: After this double-blind period, treatment with both empagliflozin 10 mg and empagliflozin 25 mg provided statistically significant improvements in HbA1c, FPG and body weight compared to placebo; all patients continued treatment with metformin and linagliptin 5 mg during the study.
Slovak: Po tomto dvojito zaslepenom období liečba s empagliflozínom 10 mg a empagliflozínom 25 mg preukázala štatisticky významné zlepšenia HbA1c, FPG a telesnej hmotnosti s porovnaní s placebom.
English: Glyxambi 10 mg/5 mg film-coated tablets
Slovak: Glyxambi 10 mg/5 mg filmom obalené tablety
English: Glyxambi 10 mg/5 mg film-coated tablets Glyxambi 25 mg/5 mg film-coated tablets empagliflozin/linagliptin
Slovak: Glyxambi 10 mg/5 mg filmom obalené tablety Glyxambi 25 mg/5 mg filmom obalené tablety empagliflozín/linagliptín
English: Pale yellow, arc triangular, flat faced, bevel-edged, film-coated tablets.
Slovak: Svetloružové, ploché, filmom obalené tablety v tvare zaobleného trojuholníka.
English: Linagliptin had no adverse effects on fertility or early embryonic development at exposures greater than 900-times the clinical exposure.
Slovak: Pri expozíciách, ktoré 900-násobne presahujú klinickú expozíciu, linagliptín nemal žiadne nežiaduce účinky na fertilitu ani skorý embryonálny vývin.
English: Change from baseline (adjusted mean)
Slovak: Zmena od východiskovej hodnoty (upravený priemer)
English: Glyxambi 25 mg/5 mg film-coated tablets
Slovak: Glyxambi 25 mg/5 mg filmom obalené tablety
English: Interstitial cell tumours in the testes were observed with a higher incidence in rats at 300 mg/kg/day and above, but not at 100 mg/kg/day which corresponds to approximately 18 times the maximal clinical exposure to empagliflozin.
Slovak: Pri samčekoch potkana sa pri dávke 300 mg/kg/deň a vyššej, ale nie pri dávke 100 mg/kg/deň, ktorá zodpovedá približne 18-násobku maximálnej klinickej expozície empagliflozínu, vo vyššej miere pozorovali nádory intersticiálnych buniek semenníkov.
English: In patients with mild, moderate and severe hepatic insufficiency (Child-Pugh classification), mean AUC and Cmax of empagliflozin increased (AUC by 23 %, 47 %, 75 % and Cmax by 4 %, 23 %,48 %) compared to subjects with normal hepatic function (see section 4.2).
Slovak: %, u pacientov so stredne závažnou poruchou funkcie pečene sa AUC empagliflozínu zvýšila približne o 47 % a Cmax približne o 23 % a u pacientov so závažnou poruchou funkcie pečene sa AUC empagliflozínu zvýšila približne o 75 % a Cmax približne o 48
English: Comparison vs. linagliptin 5 mg - adjusted mean
Slovak: Porovnanie s linagliptínom 5 mg upravený priemer
English: Nephropathy
Slovak: Nazofaryngitída
English: In patients with mild, moderate or severe renal impairment (eGFR <30 to <90 mL/min/1.73 m2) and patients with kidney failure or end stage renal disease (ESRD), AUC of empagliflozin increased by approximately 18 %, 20 %, 66 %, and 48 %, respectively compared to subjects with normal renal function.
Slovak: 30 až < 90 ml/min/1,73 m2) o 66 % a u pacientov so zlyhávaním obličiek alebo ochorením obličiek v terminálnom štádiu (ESRD) približne o 48
English: A statistically significant greater number of patients with a baseline HbA1c ≥7.0 % and treated with linagliptin achieved a target HbA1c of <7 % compared to placebo (see Table 4).
Slovak: 7,0 % liečených linagliptínom dosiahol cieľovú hodnotu HbA1c <
English: The unbound concentrations, which are usually less than 1 % at the therapeutic dose of linagliptin, were increased 4 to 5-fold after co-administration with ritonavir.
Slovak: Koncentrácie neviazaného liečiva, ktoré sú pri terapeutickej dávke linagliptínu zvyčajne menšie než 1
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.
Slovak: V klinických skúšaniach s Glyxambi bola zvýšená miera močenia u pacientov liečených Glyxambi (Glyxambi 25 mg/5 mg: 2,6 %; Glyxambi 10 mg/5 mg: 1,4
English: Empagliflozin 10 mg
Slovak: Po perorálnej dávke 10 mg [
English: Glyxambi 25 mg/5 mg film-coated tablets (tablets) are pale pink, arc triangular, flat faced and beveledged.
Slovak: Glyxambi 25 mg/5 mg filmom obalené tablety sú svetloružové, ploché , filmom obalené tablety v tvare zaobleného trojuholníka.
English: Patients ( %) achieving HbA1c <7 % with baseline HbA1c ≥7 %24 weeks
Slovak: 7 % s východiskovou hodnotou HbA1c ≥
English: Glyxambi 10 mg/5 mg film-coated tablets (tablets) are pale yellow, arc triangular, flat faced and bevel-edged.
Slovak: Glyxambi 10 mg/5 mg filmom obalené tablety sú svetložlté, ploché, filmom obalené tablety v tvare zaobleného trojuholníka.
English: The frequency of patients with major hypoglycaemic events was increased in patients treated with empagliflozin compared to placebo when given as add-on to basal insulin +/- metformin and +/sulphonylurea (empagliflozin 10 mg: 0 %, empagliflozin 25 mg: 1.3 %, placebo: 0 % during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 0 %, empagliflozin 25 mg: 1.3 %, placebo 0 % over the 78-week trial), and add-on to MDI insulin with or without metformin (empagliflozin 10 mg: 1.6 %, empagliflozin 25 mg: 0.5 %, placebo: 1.6 % during initial 18 weeks treatment when insulin could not be adjusted and over the 52-week trial).
Slovak: Frekvencia pacientov so závažnými hypoglykemickými udalosťami sa zvýšila u pacientov liečených empagliflozínom v porovnaní s placebom, ak sa liek podával vo forme prídavnej liečby k bazálnemu inzulínu +/- metformín a +/- sulfonylmočovina (10 mg empagliflozínu: 0 %, 25 mg emplagliflozínu: 1,3
English: Gender had no clinically relevant effect on the pharmacokinetics of empagliflozin or linagliptin based on population pharmacokinetic analysis.
Slovak: Pohlavie nemalo na základe analýzy populačnej farmakokinetiky žiadny klinicky významný účinok na farmakokinetiku empagliflozínu alebo linagliptínu.
English: Renal impairment:
Slovak: Limited Tel:
English: Age did not have a clinically meaningful impact on the pharmacokinetics of empagliflozin or linagliptin based on population pharmacokinetic analysis.
Slovak: Vek nemal na základe analýzy populačnej farmakokinetiky žiadny klinicky významný vplyv na farmakokinetiku empagliflozínu alebo linagliptínu.
English: The frequency of volume depletion events was increased in patients 75 years and older treated with empagliflozin 10 mg (2.3 %) or empagliflozin 25 mg (4.3 %) compared to placebo (2.1 %).
Slovak: U pacientov vo veku 75 rokov a starších liečených 10 mg empagliflozínu (2,3
English: Glyxambi should not be used to treat type 1 diabetes.
Slovak: U pacientov s cukrovkou 1. typu sa Glyxambi nemá používať.
English: Body mass index had no clinically relevant effect on the pharmacokinetics of empagliflozin or linagliptin based on population pharmacokinetic analysis.
Slovak: Index telesnej hmotnosti nemá na základe analýzy populačnej farmakokinetiky žiadny klinicky významný účinok na farmakokinetiku empagliflozínu alebo linagliptínu.
English: Your blood sugar levels may increase when you stop taking Glyxambi.
Slovak: Ak prestanete užívať Glyxambi, vaša hladina cukru v krvi sa môže zvýšiť.
English: The double-blind, placebo-controlled CARMELINA study evaluated the cardiovascular and renal safety of linagliptin versus placebo as adjunct to standard care therapy in patients with type 2 diabetes and with increased CV risk evidenced by a history of established macrovascular or renal disease.
Slovak: V dvojito zaslepenej, placebom kontrolovanej štúdii CARMELINA sa hodnotila kardiovaskulárna a renálna bezpečnosť linagliptínu oproti placebu ako doplnok k bežnej liečbe u pacientov s diabetes mellitus
English: In a factorial design study patients inadequately controlled on metformin were treated for 24-weeks with Glyxambi 10 mg/5 mg, Glyxambi 25 mg/5 mg, empagliflozin 10 mg, empagliflozin 25 mg or linagliptin 5 mg.
Slovak: Pacienti štúdie s faktoriálnym dizajnom s nedostatočnou kontrolou pri metformíne boli liečení 24 týždňov s Glyxambi 10 mg/5 mg, Glyxambi 25 mg/5 mg, empagliflozínom 10 mg, empagliflozínom 25 mg alebo linagliptínom 5 mg. Liečba s Glyxambi viedla k štatisticky významnému zlepšeniu HbA1c a hladiny glukózy nalačno (FPG) v porovnaní s 5 mg linagliptínu, ako aj v porovnaní s 10 mg alebo 25 mg empagliflozínu.
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.
Slovak: V klinických skúšaniach s Glyxambi boli infekcie pohlavných orgánov u pacientov liečených Glyxambi (Glyxambi 25 mg/5 mg: 3,0 %; Glyxambi 10 mg/5 mg: 2,5
English: In clinical trials with empagliflozin, the overall frequency of patients with increased blood creatinine and decreased glomerular filtration rate were similar between empagliflozin and placebo (blood creatinine increased: empagliflozin 10 mg 0.6%, empagliflozin 25 mg 0.1%, placebo 0.5%; glomerular filtration rate decreased: empagliflozin 10 mg 0.1%, empagliflozin 25 mg 0%, placebo 0.3%).
Slovak: V klinických skúšaniach s empagliflozínom bola celková frekvencia výskytu pacientov so zvýšenou hladinou kreatinínu v krvi a poklesom glomerulárnej filtrácie podobná pri empagliflozíne a placebe (nárast kreatinínu v krvi: empagliflozín 10 mg 0,6
English: Hypoglycaemias in the placebo-controlled studies (10.9 %; N=471) were mild (80 %; N=384), moderate (16.6 %; N=78) or severe (1.9 %; N=9) in intensity.
Slovak: %; N= 384), stredne závažné (16,6
English: In empagliflozin trials, the overall frequency of urinary tract infection was similar in patients treated with empagliflozin 25 mg and placebo (7.0 % and 7.2 %), and higher in patients treated with empagliflozin 10 mg (8.8 %).
Slovak: V skúšaniach s empagliflozínom bola celková frekvencia výskytu infekcie močových ciest u pacientov liečených 25 mg empagliflozínu a placebom (7,0
English: NAME OF THE MEDICINAL PRODUCT Glyxambi 10 mg/5 mg film-coated tablets Glyxambi 25 mg/5 mg film-coated tablets
Slovak: Glyxambi 10 mg/5 mg filmom obalené tablety Glyxambi 25 mg/5 mg filmom obalené tablety
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.
Slovak: Pri samčekoch potkana sa pri najvyššej dávke, ale nie pri 300 mg/kg/deň, čo zodpovedá 26-násobku maximálnej klinickej expozície empagliflozínu, pozorovali benígne vaskulárne proliferatívne lézie (hemangiómy) mezenterickej lymfatickej uzliny súvisiace s liečbou.
English: The most frequent adverse reaction was urinary tract infection (7.5 % with Glyxambi 10 mg empagliflozin / 5 mg linagliptin and 8.5 % with Glyxambi 25 mg empagliflozin / 5 mg linagliptin) (see Description of selected adverse reactions).
Slovak: % s Glyxambi 25 mg empagliflozín/5 mg linagliptín) (pozri Popis vybraných nežiaducich reakcií).
English: Metformin + linagliptin 5 mg Empagliflozin 10 mg
Slovak: Glyxambi 10 mg/5 mg empagliflozín 25 mg empagliflozín 10 mg linagliptín 5 mg
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.
Slovak: V klinických skúšaniach s Glyxambi sa nepozoroval významný rozdiel vo frekvencii infekcií močových ciest u pacientov liečených Glyxambi (Glyxambi 25 mg/5 mg: 8,5
English: Pale pink, arc triangular, flat faced, bevel-edged, film-coated tablets.
Slovak: Svetložlté, ploché, filmom obalené tablety v tvare zaobleného trojuholníka.
English: In a pre-specified subgroup of patients with baseline HbA1c greater or equal than 8.5 %, the reduction from baseline in HbA1c at 24 weeks with Glyxambi 25 mg/5 mg was -1.8 % (p<0.0001 versus linagliptin 5 mg, p<0.001 versus empagliflozin 25 mg) and with Glyxambi 10 mg/ 5 mg -1.6 % (p<0.01 versus linagliptin 5 mg, n.s. versus empagliflozin 10 mg).
Slovak: V preddefinovanej podskupine pacientov s východiskovou hodnotou HbA1c vyššou alebo rovnajúcou sa 8,5 % bol pokles od východiskovej hodnoty v HbA1c s Glyxambi 25 mg/5 mg −1,8
English: Urinary tract infection, seen commonly The signs of urinary tract infection are:
Slovak: Prejavmi infekcie močových ciest sú:
English: NAME OF THE MEDICINAL PRODUCT Glyxambi 10 mg/5 mg tablets empagliflozin/linagliptin
Slovak: Glyxambi 10 mg/5 mg tablety empagliflozín/linagliptín
English: Exposure in T2DM patients with severe RI was increased by about 1.4-fold compared to T2DM patients with normal renal function.
Slovak: Pri stredne ťažkom poškodení funkcie obličiek sa pozoroval mierny vzostup expozície asi o 1,7-násobok v porovnaní s kontrolnou skupinou . Expozícia pacientov s diabetes mellitus 2. typu s ťažkou renálnou insuficienciou sa zvýšila asi o
English: • cough
Slovak: (LOCF)
English: In a pre-specified subgroup of patients with baseline HbA1c greater or equal than 8.5 % the reduction from baseline in HbA1c with empagliflozin 25 mg/linagliptin 5 mg was -1.3 % at 24 weeks (p<0.0001 versus placebo and linagliptin 5 mg) and with empagliflozin 10 mg/ linagliptin 5 mg -1.3 % at 24 weeks (p<0.0001 versus placebo and linagliptin 5 mg).
Slovak: V preddefinovanej podskupine pacientov s východiskovou hodnotou HbA1c vyššou alebo rovnajúcou sa 8,5 % bol pokles od východiskovej hodnoty v HbA1c s empagliflozínom 25 mg/linagliptín 5 mg
English: In patients inadequately controlled after this 16 week period, patients received double-blind treatment with either linagliptin 5 mg or placebo for 24-weeks.
Slovak: Pacientom s nedostatočnou kontrolou pri maximálnej tolerovanej dávke metformínu bola po dobu 16 týždňov pridaná otvorená liečba empagliflozínom 10 mg alebo empagliflozínom 25 mg. Pacientom s nedostatočnou kontrolou po tomto 16-týždňovom období bola podaná dvojito zaslepená liečba s linagliptínom 5 mg alebo placebom po dobu 24 týždňov.
English: Inhibition of SGLT2 in patients with type 2 diabetes mellitus and hyperglycaemia leads to excess glucose excretion in the urine.
Slovak: 2. typu a hyperglykémiou vedie k rozsiahlemu vylučovaniu glukózy do moču.
English: NAME OF THE MEDICINAL PRODUCT Glyxambi 25 mg/5 mg tablets empagliflozin/linagliptin
Slovak: Glyxambi 25 mg/5 mg tablety empagliflozín/linagliptín
English: Table 1 Adverse reactions System organ class
Slovak: Trieda orgánových systémov Frekvencia výskytu Nežiaduca reakcia Infekcie a nákazy
English: NAME OF THE MEDICINAL PRODUCT Glyxambi 10 mg/5 mg film-coated tablets empagliflozin/linagliptin
Slovak: Glyxambi 10 mg/5 mg filmom obalené tablety empagliflozín/linagliptín
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.
Slovak: Nie je známe, či má Glyxambi škodlivý účinok pre nenarodené dieťa.
English: The treatment with Glyxambi resulted in statistically significant improvements in HbA1c and fasting plasma glucose (FPG) compared to linagliptin 5 mg and also compared to empagliflozin 10 mg or 25 mg. Glyxambi also provided statistically significant improvements in body weight compared to linagliptin 5 mg.
Slovak: Glyxambi spôsobil aj štatisticky významné zlepšenie telesnej hmotnosti v porovnaní s linagliptínom 5 mg.
English: Comparison vs. placebo (odds ratio) (95 % CI)
Slovak: Pomer rizika v porovnaní s placebom (95,02
English: • skin rash
Slovak: • kožná vyrážka,
English: NAME OF THE MEDICINAL PRODUCT Glyxambi 25 mg/5 mg film-coated tablets empagliflozin/linagliptin
Slovak: Glyxambi 25 mg/5 mg filmom obalené tablety empagliflozín/linagliptín
English: In clinical trials with Glyxambi, there was no notable difference in the frequency of volume depletion in patients treated with Glyxambi (Glyxambi 25 mg/5 mg: 0.4 %; Glyxambi 10 mg/5 mg: 0.8 %) compared to the patients treated with empagliflozin and linagliptin.
Slovak: V klinických skúšaniach s Glyxambi sa nepozoroval viditeľný rozdiel vo frekvencii deplécie objemu u pacientov liečených Glyxambi (Glyxambi 25 mg/5 mg: 0,4
English: Amylase increased
Slovak: Zvýšená hladina amylázy Zvýšená hladina lipázy
English: Increased urination Dysuria
Slovak: Zvýšená miera močenia Dyzúria
English: A total of 2,173 patients with type 2 diabetes mellitus and inadequate glycaemic control were treated in clinical studies to evaluate the safety and efficacy of Glyxambi; 1,005 patients were treated with Glyxambi 10 mg empagliflozin/5 mg linagliptin or 25 mg empagliflozin/5 mg linagliptin.
Slovak: 1 005 pacientov bolo liečených Glyxambi 10 mg empagliflozínu/5 mg linagliptínu alebo 25 mg empagliflozínu/5 mg linagliptínu.
English: Linagliptin 5 mg
Slovak: 5 mg linagliptín a 8,5
English: Comparison vs. placebo (adjusted mean) (95 % CI)
Slovak: Porovnanie s placebom: (upravený priemer)
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.
Slovak: ≥ 60 ml/min/1,73 m2 alebo klírensom kreatinínu (CrCl)
English: In clinical trials with Glyxambi, the frequency of patients with increased blood creatinine (Glyxambi 25 mg/5 mg: 0.4%; Glyxambi 10 mg/5 mg: 0%) and decreased glomerular filtration rate (Glyxambi 25 mg/5 mg: 0.4%; Glyxambi 10 mg/5 mg: 0.6%) has been comparable to those reported from the empagliflozin clinical trials.
Slovak: %; Glyxambi 10 mg/5 mg: 0 %) a pokles rýchlosti glomerulárnej filtrácie (Glyxambi 25 mg/5 mg: 0,4
English: • In patients with an eGFR <60 mL/min/1.73 m 2 or CrCl <60 mL/min, Glyxambi should not be initiated.
Slovak: Glyxambi sa nemá začať podávať pacientom s eGFR < 60 ml/min/1,73 m 2 alebo
English: The frequency of patients with major hypoglycaemic events was low (< 1 %) and similar for empagliflozin and placebo as monotherapy, as add-on to metformin +/- sulfonylurea, and as add-on to pioglitazone +/- metformin.
Slovak: %) a bola podobná ako pri monoterapii empagliflozínom a placebom vo forme prídavnej liečby k liečbe metformínom so sulfonylmočovinou alebo bez nej alebo ako prídavná liečba k pioglitazónu s metformínom alebo bez neho.
English: Following a [
Slovak: 10 do <
English: Česká republika Boehringer Ingelheim spol.
Slovak: United Kingdom Boehringer Ingelheim
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.
Slovak: Pacienti randomizovaní do skupiny s linagliptínom 5 mg dostávali fixnú kombináciu tabliet Glyxambi 10 mg/5 mg plus metformín alebo fixnú kombináciu tabliet Glyxambi 25 mg/5 mg plus metformín.
English: Film coating Hypromellose 2910 Mannitol (E421) Talc
Slovak: Filmový obal hypromelóza 2910 manitol (E421) mastenec oxid titaničitý (E171) makrogol 6000 žltý oxid železitý (E172)
English: Paediatric patients
Slovak: Osobitné skupiny pacientov
English: Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 173
Slovak: KG Binger Strasse 173
English: Metformin + empagliflozin 10 mg
Slovak: % s Glyxambi 10 mg empagliflozín/
English: The pack sizes are 7 x 1, 10 x 1, 14 x 1, 28 x 1, 30 x 1, 60 x 1, 70 x 1, 90 x 1 and 100 x 1 film-coated tablets.
Slovak: Veľkosti balenia po 7 x 1, 10 x 1, 14
English: Target species
Slovak: Cieľové zvieratá
English: EU Number Tradename Strength
Slovak: EU číslo Názov lieku
English: Do not give this medicine to children less than 12 years of age.
Slovak: Nepodávajte tento liek deťom mladším ako 12 rokov.
English: The recommended dose is one tablet once a day with water, with or without food.
Slovak: Odporúčaná dávka je jedna tableta raz denne s vodou, s jedlom alebo bez jedla.
English: • if you are allergic to desloratadine, or any of the other ingredients of this medicine (listed in section 6) or to loratadine.
Slovak: • ak ste alergický na desloratadín alebo na ktorúkoľvek z ďalších zložiek tohto lieku (uvedených v časti 6) alebo na loratadín.
English: Adults and adolescents 12 years of age and over
Slovak: Dospelí a dospievajúci vo veku 12 rokov a starší
English: Date of first authorisation: 24 November 2011 Date of latest renewal: 8 August 2016
Slovak: Dátum posledného predĺženia registrácie: 8. augusta 2016
English: Packs of 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 90, 100 and 105 film-coated tablets.
Slovak: Balenia 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 90, 100 a 105 filmom obalených tabliet.
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
Slovak: • zožltnutie kože a/alebo očí • zvýšená citlivosť kože na slnko, dokonca aj v prípade zamračeného počasia, a na UV (ultrafialové)
English: It also contains lactose monohydrate.
Slovak: Obsahuje tiež monohydrát laktózy.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Slovak: Pacienti so zriedkavými dedičnými problémami galaktózovej intolerancie, laponského deficitu laktázy alebo glukózo-galaktózovej malabsorpcie nesmú užívať tento liek.
English: Treatment with desloratadine also significantly reduced interference with sleep and daytime function, as measured by a fourpoint scale used to assess these variables.
Slovak: Liečba desloratadínom tiež významne redukovala interferenciu so spánkom a dennými funkciami, ako sa nameralo štvor-bodovou stupnicou na zisťovanie týchto premenných.
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.
Slovak: Ak zabudnete užiť Desloratadin Teva Ak zabudnete načas užiť vašu dávku, užite ju čo najskôr, ako je to možné, a potom sa vráťte k vášmu pravidelnému dávkovaciemu rozvrhu.
English: Use caution when taking Desloratadine Teva with alcohol.
Slovak: Buďte opatrní pri užívaní Desloratadinu Teva s alkoholom.
English: ● unusual weakness
Slovak: • nezvyčajná slabosť
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.
Slovak: Čo sa týka trvania liečby, váš lekár určí, na ktorý typ alergickej rinitídy trpíte, a rozhodne, ako dlho musíte Desloratadin Teva užívať.
English: Desloratadine Teva with food, drink and alcohol
Slovak: Desloratadin Teva a jedlo, nápoje a alkohol
English: Adverse reactions seen with desloratadine
Slovak: Nežiaduce reakcie pozorované pri desloratadine
English: Other medicines and Desloratadine Teva
Slovak: Iné lieky a Desloratadin Teva
English: There are no known interactions of Desloratadine Teva with other medicines.
Slovak: Nie sú známe žiadne interakcie Desloratadinu Teva s inými liekmi.