FrancophonIA/ELRC3.0 huggingface dataset:
English: Time to first event of CV death, non-fatal MI, or non-fatal stroke N (%) Hazard ratio vs. placebo (95.02% CI) p−value for superiority
Danish: Tid til første hændelse af CV-død, ikke-dødeligt MI eller ikke-dødelig apopleksi, N (%) Hazard ratio.
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.
Danish: I kliniske studier med Glyxambi sås ingen særlig forskel på hyppigheden af urinvejsinfektioner hos patienter, der fik Glyxambi (Glyxambi 25 mg/5 mg: 8,5 %; Glyxambi 10 mg/5 mg: 7,5 %), sammenlignet med patienter, der fik empagliflozin og linagliptin.
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.
Danish: Det vides ikke, om Glyxambi er skadeligt for det ufødte barn.
English: Linagliptin had no clinically relevant effect on the pharmacokinetics of metformin, glibenclamide, simvastatin, pioglitazone, warfarin, digoxin, empagliflozin or oral contraceptives providing in vivo evidence of a low propensity for causing drug interactions with substrates of CYP3A4, CYP2C9, CYP2C8, P-gp and organic cationic transporter (OCT).
Danish: Dette giver in vivo-evidens for lav tilbøjelighed til at forårsage lægemiddelinteraktioner med substrater for CYP3A4, CYP2C9, CYP2C8, P-gp og organisk kationtransporter (OCT).
English: How to take Glyxambi
Danish: Sådan skal du tage Glyxambi
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.
Danish: I kliniske studier med Glyxambi blev øget vandladning rapporteret hyppigere for patienter behandlet med Glyxambi (Glyxambi 25 mg/5 mg: 2,6 %; Glyxambi 10 mg/5 mg: 1,4 %) end for linagliptin og med samme hyppighed som for empagliflozin.
English: One main metabolite with a relative exposure of 13.3 % of linagliptin at steady-state was detected which was found to be pharmacologically inactive and thus to not contribute to the plasma DPP-4 inhibitory activity of linagliptin.
Danish: En hovedmetabolit med en relativ eksponering på 13,3 % af linagliptin-dosis ved steady state blev påvist.
English: In the CARMELINA study (see section 5.1), bullous pemphigoid was reported in 0.2% patients treated with linagliptin and in no patients treated with placebo.
Danish: 5.1) blev bulløs pemfigoid rapporteret hos 0,2 % af patienterne behandlet med linagliptin, og hos ingen af de patienter, der fik placebo.
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.
Danish: I kliniske studier med Glyxambi blev genitale infektioner rapporteret hyppigere hos patienter, der blev behandlet med Glyxambi (Glyxambi 25 mg/5 mg: 3,0 %; Glyxambi 10 mg/5 mg: 2,5 %), sammenlignet med linagliptin, men mindre hyppigt end for empagliflozin.
English: STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 10 mg empagliflozin and 5 mg linagliptin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 10 mg empagliflozin og 5 mg linagliptin.
English: However, renal function and risk of volume depletion should be taken into account in elderly patients (see sections 4.4 and 4.8).
Danish: Dosisjustering er ikke nødvendig på baggrund af alder. Nyrefunktion og risiko for volumendepletering skal dog tages i betragtning hos ældre patienter (se pkt.
English: Patients randomized to the empagliflozin 10 mg or 25 mg groups were receiving Glyxambi 10 mg/5 mg or 25 mg/5 mg with background metformin
Danish: Patienter, der blev randomiseret til empagliflozin 10 mg- eller 25 mg-grupperne, fik Glyxambi 10 mg/5 mg eller 25 mg/5 mg sammen med metformin som baggrundsbehandling Patienter, der blev randomiseret til placebo-gruppen, fik placebo plus linagliptin 5 mg sammen med metformin som baggrundsbehandling
English: Non-fatal stroke N (%) Hazard ratio vs. placebo (95% CI) p−value
Danish: Ikke-dødeligt MI, N (%) Hazard ratio vs. placebo (95 % CI) p-værdi
English: Comparison vs. empagliflozin - adjusted mean
Danish: Sammenligning med empagliflozin justeret middelværdi
English: • In patients with an eGFR <60 mL/min/1.73 m 2 or CrCl <60 mL/min, Glyxambi should not be initiated.
Danish: • Behandling med Glyxambi bør ikke initieres hos patienter med eGFR under 60 ml/min/1,73 m eller CrCl under 60 ml/min.
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)
Danish: Glyxambi 25 mg/5 mg filmovertrukne tabletter EU/1/16/1146/010 (7 x 1 filmovertrukne tabletter) EU/1/16/1146/011 (10 x 1 filmovertrukne tabletter) EU/1/16/1146/012 (14 x 1 filmovertrukne tabletter) EU/1/16/1146/013 (28 x 1 filmovertrukne tabletter) EU/1/16/1146/014 (30 x 1 filmovertrukne tabletter) EU/1/16/1146/015 (60 x 1 filmovertrukne tabletter) EU/1/16/1146/016 (70 x 1 filmovertrukne tabletter) EU/1/16/1146/017 (90 x 1 filmovertrukne tabletter) EU/1/16/1146/018 (100 x 1 filmovertrukne tabletter)
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).
Danish: Sammenlignet med placebo var alvorlig hypoglykæmi hyppigere hos patienter, der fik empagliflozin, når det blev givet som tillæg til basal insulin med eller uden metformin og med eller uden sulfonylurinstof (under de indledende 18 ugers behandling, hvor insulin ikke kunne justeres: empagliflozin 10 mg: 0 %; empagliflozin 25 mg: 1,3 %; placebo: 0 %.
English: Foot care
Danish: # Se pkt.
English: Gender had no clinically relevant effect on the pharmacokinetics of empagliflozin or linagliptin based on population pharmacokinetic analysis.
Danish: Baseret på en farmakokinetisk populationsanalyse havde køn ingen klinisk relevant indvirkning på empagliflozins eller linagliptins farmakokinetik.
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
Danish: EU/1/16/1146/010 7 x 1 filmovertrukne tabletter EU/1/16/1146/011 10 x 1 filmovertrukne tabletter EU/1/16/1146/012 14 x 1 filmovertrukne tabletter EU/1/16/1146/013 28 x 1 filmovertrukne tabletter EU/1/16/1146/014 30 x 1 filmovertrukne tabletter EU/1/16/1146/015 60 x 1 filmovertrukne tabletter EU/1/16/1146/016 70 x 1 filmovertrukne tabletter EU/1/16/1146/017 90 x 1 filmovertrukne tabletter EU/1/16/1146/018 100 x 1 filmovertrukne tabletter
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
Danish: EU/1/16/1146/001 7 x 1 filmovertrukne tabletter EU/1/16/1146/002 10 x 1 filmovertrukne tabletter EU/1/16/1146/003 14 x 1 filmovertrukne tabletter EU/1/16/1146/004 28 x 1 filmovertrukne tabletter EU/1/16/1146/005 30 x 1 filmovertrukne tabletter EU/1/16/1146/006 60 x 1 filmovertrukne tabletter EU/1/16/1146/007 70 x 1 filmovertrukne tabletter EU/1/16/1146/008 90 x 1 filmovertrukne tabletter EU/1/16/1146/009 100 x 1 filmovertrukne tabletter
English: If you take more of this medicine than you should, immediately talk to a doctor or go to a hospital.
Danish: Hvis du får de anførte symptomer hyppigere, skal du kontakte lægen.
English: NAME OF THE MEDICINAL PRODUCT Glyxambi 10 mg/5 mg tablets empagliflozin/linagliptin
Danish: LÆGEMIDLETS NAVN Glyxambi 10 mg/5 mg tabletter empagliflozin/linagliptin
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)
Danish: Glyxambi 10 mg/5 mg filmovertrukne tabletter EU/1/16/1146/001 (7 x 1 filmovertrukne tabletter) EU/1/16/1146/002 (10 x 1 filmovertrukne tabletter) EU/1/16/1146/003 (14 x 1 filmovertrukne tabletter) EU/1/16/1146/004 (28 x 1 filmovertrukne tabletter) EU/1/16/1146/005 (30 x 1 filmovertrukne tabletter) EU/1/16/1146/006 (60 x 1 filmovertrukne tabletter) EU/1/16/1146/007 (70 x 1 filmovertrukne tabletter) EU/1/16/1146/008 (90 x 1 filmovertrukne tabletter) EU/1/16/1146/009 (100 x 1 filmovertrukne tabletter)
English: NAME OF THE MEDICINAL PRODUCT Glyxambi 25 mg/5 mg tablets empagliflozin/linagliptin
Danish: LÆGEMIDLETS NAVN Glyxambi 25 mg/5 mg tabletter empagliflozin/linagliptin
English: One side is debossed with the Boehringer Ingelheim company symbol, the other side is debossed with “25/5” (tablet dimensions: 8 mm each side).
Danish: Blegrosa, trekantet filmovertrukken tablet på 8 mm, som er plan med buede sider og præget med "25/5" på den ene side og Boehringer Ingelheims firmalogo på den anden side.
English: Glyxambi 25 mg/5 mg film-coated tablets (tablets) are pale pink, arc triangular, flat faced and beveledged.
Danish: Glyxambi 25 mg/5 mg er blegrosa, trekantede filmovertrukne tabletter på 8 mm, som er plane med buede sider og præget med "25/5" på den ene side og firmalogo på den anden.
English: All-cause mortality N (%) Hazard ratio vs. placebo (95% CI) p-value
Danish: Mortalitet uanset årsag, N (%) Hazard ratio vs. placebo (95 % CI) p-værdi
English: One side is debossed with the Boehringer Ingelheim company symbol, the other side is debossed with “10/5” (tablet dimensions: 8 mm each side).
Danish: Lysegul, trekantet filmovertrukken tablet på 8 mm, som er plan med buede sider og præget med "10/5" på den ene side og Boehringer Ingelheims firmalogo på den anden side.
English: In non-diabetic patients with mild, moderate and severe hepatic insufficiency (according to the ChildPugh classification), mean AUC and Cmax of linagliptin were similar to healthy subjects following administration of multiple 5 mg doses of linagliptin.
Danish: Efter administration af gentagne doser linagliptin 5 mg var linagliptins middel-AUC og -Cmax sammenlignelige hos ikke-diabetiske patienter med let, moderat og svært nedsat leverfunktion (i henhold til Child-Pugh-klassifikation) og hos raske forsøgspersoner.
English: Glyxambi 25 mg/5 mg film-coated tablets Tablet core
Danish: Glyxambi 25 mg/5 mg filmovertrukne tabletter Tabletkerne:
English: NAME OF THE MEDICINAL PRODUCT Glyxambi 10 mg/5 mg film-coated tablets empagliflozin/linagliptin
Danish: LÆGEMIDLETS NAVN Glyxambi 10 mg/5 mg filmovertrukne tabletter empagliflozin/linagliptin
English: NAME OF THE MEDICINAL PRODUCT Glyxambi 25 mg/5 mg film-coated tablets empagliflozin/linagliptin
Danish: LÆGEMIDLETS NAVN Glyxambi 25 mg/5 mg filmovertrukne tabletter empagliflozin/linagliptin
English: Body mass index had no clinically relevant effect on the pharmacokinetics of empagliflozin or linagliptin based on population pharmacokinetic analysis.
Danish: Baseret på en farmakokinetisk populationsanalyse havde BMI ingen klinisk relevant indvirkning på empagliflozins eller linagliptins farmakokinetik.
English: Due to the mechanism of action of empagliflozin, patients taking Glyxambi will test positive for glucose in their urine.
Danish: Test for glucose i urinen vil være positiv på grund af empagliflozins virkningsmekanisme.
English: Glyxambi 10 mg/5 mg film-coated tablets Tablet core
Danish: Glyxambi 10 mg/5 mg filmovertrukne tabletter Tabletkerne:
English: Age did not have a clinically meaningful impact on the pharmacokinetics of empagliflozin or linagliptin based on population pharmacokinetic analysis.
Danish: Baseret på en farmakokinetisk populationsanalyse havde alder ingen klinisk relevant indvirkning på empagliflozins eller linagliptins farmakokinetik.
English: Glyxambi 10 mg/5 mg film-coated tablets Glyxambi 25 mg/5 mg film-coated tablets empagliflozin/linagliptin
Danish: Glyxambi 10 mg/5 mg filmovertrukne tabletter Glyxambi 25 mg/5 mg filmovertrukne tabletter
English: The intensity of urinary tract infections was similar to placebo for mild, moderate and severe intensity reports.
Danish: Sværhedsgraden (let, moderat, svær) af urinvejsinfektionerne var den samme som for placebo.
English: • urine that appears cloudy
Danish: • uklar urin
English: Glyxambi 10 mg/5 mg film-coated tablets (tablets) are pale yellow, arc triangular, flat faced and bevel-edged.
Danish: Glyxambi 10 mg/5 mg er lysegule, trekantede filmovertrukne tabletter på 8 mm, som er plane med buede sider og præget med "10/5" på den ene side og firmalogo på den anden.
English: Therefore, special attention should be given to their volume intake in case of co-administered medicinal products which may lead to volume depletion (e.g. diuretics, ACE inhibitors).
Danish: Ved samtidig administration af lægemidler, der kan medføre volumendepletering (f.eks. diuretika, ACE-hæmmere), skal man derfor være særligt opmærksom på patientens væskeindtagelse.
English: If you take more Glyxambi than you should
Danish: Hvis du har taget for meget Glyxambi
English: • When eGFR is persistently below 45 mL/min/1.73 m2 or CrCl persistently below 45 mL/min, treatment should be discontinued (see sections 4.4, 4.8, 5.1, and 5.2).
Danish: • Hvis eGFR vedvarende ligger under 45 ml/min/1,73 m2, eller CrCl vedvarende ligger under
English: Packaging Content Package size
Danish: Emballage Indhold Salgspakninger Tilbageholdelsestid
English: EU Number Tradename Strength
Danish: Eu Nummer
English: Date of first authorisation: 24 November 2011 Date of latest renewal: 8 August 2016
Danish: Dato for første tilladelse: 24. november 2011 Dato for seneste fornyelse: 8. august 2016
English: It helps control your allergic reaction and its symptoms.
Danish: Det hjælper med at regulere din allergiske reaktion og dens symptomer
English: Common: the following may affect up to 1 in 10 people
Danish: Almindelig: følgende kan forekomme hos op til 1 ud af 10 personer
English: Adults and adolescents 12 years of age and over
Danish: Voksne og teenagere i alderen 12 år og derover
English: Do not use this medicine if you notice any change in the appearance of the tablets.
Danish: Tag ikke lægemidler, hvis du bemærker ændringer i tabletternes udseende.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og blisterpakningen efter ”EXP”.
English: The recommended dose is one tablet once a day with water, with or without food.
Danish: Den sædvanlige dosis er en tablet en gang dagligt sammen med vand, med eller uden mad.
English: This medicinal product does not require any special storage conditions.
Danish: Denne medicin kræver ikke særlige opbevaringsforhold.
English: ● weight increased ● increased appetite
Danish: ● vægtforøgelse ● øget appetit
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.
Danish: Med hensyn til varigheden af behandlingen, vil din læge bestemme hvilken type allergisk snue, du lider af, og vil fastsætte, hvor længe du skal tage Desloratadine Teva.
English: Packs of 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 90, 100 and 105 film-coated tablets.
Danish: Pakninger med 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 90, 100 og 105 filmovertrukne tabletter.
English: Treatment with desloratadine also significantly reduced interference with sleep and daytime function, as measured by a fourpoint scale used to assess these variables.
Danish: Behandling med desloratadin reducerede også signifikant påvirkningen af søvn og daglig funktionsevne, målt ved en fire-points skala, der anvendtes for at vurdere disse parametre.
English: • if you have poor kidney function.
Danish: - hvis du har dårlig nyrefunktion.
English: Desloratadine Teva may be taken with or without a meal.
Danish: Desloratadine Teva kan tages med eller uden mad.
English: Indigo carmine (E132)
Danish: Indigotin (E132).
English: Desloratadine Teva with food, drink and alcohol
Danish: Brug af Desloratadine Teva sammen med mad, drikke og alkohol
English: Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures
Danish: Svimmelhed, somnolens, insomnia, psykomotorisk hyperaktivitet, anfald
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: There are no known interactions of Desloratadine Teva with other medicines.
Danish: Der er ingen kendte interaktioner mellem Desloratadine Teva og andre lægemidler.
English: ● change in the way the heart beats
Danish: ● ændring i måden hjertet slår
English: • if you are allergic to desloratadine, or any of the other ingredients of this medicine (listed in section 6) or to loratadine.
Danish: • hvis du er allergisk over for desloratadin, et af de øvrige indholdsstoffer i Desloratadine Teva (angivet i afsnit 6) eller over for loratadin.
English: Taking Desloratadine Teva is not recommended if you are pregnant or nursing a baby.
Danish: Det frarådes, at du tager Desloratadine Teva, hvis du er gravid, eller hvis du ammer dit spædbarn.
English: Adults During the marketing of Desloratadine Teva, the following side effects were reported as:
Danish: Voksne Efter markedsføring af Desloratadine Teva er følgende bivirkninger blevet rapporteret:
English: Microcrystalline cellulose Pregelatinised maize starch Talc
Danish: Mikrokrystallinsk cellulose Prægelatineret majsstivelse Talcum
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.
Danish: Sikkerhed og virkning af Desloratadine Teva 5 mg filmovertrukne tabletter hos børn under 12 år er ikke klarlagt.
English: Use caution when taking Desloratadine Teva with alcohol.
Danish: Du skal udvise forsigtighed, hvis du tager Desloratadine Teva sammen med alkohol.
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).
Danish: Desloratadin Teva 5 mg filmovertrukne tabletter er pakket i blisterpakninger med 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 90, 100 og 105 filmovertrukne tabletter og i perforerede enkeltdosisblisterpakninger med 50 x 1 filmovertrukket tablet (enkeltdosispakning).
English: It also contains lactose monohydrate.
Danish: Indeholder også lactosemonohydrat.
English: Desloratadine Teva is an antiallergy medicine that does not make you drowsy.
Danish: Desloratadine Teva er et lægemiddel mod allergi, som ikke gør dig døsig.
English: Blue, round, biconvex film-coated tablet - printed in with ink: “D5” on one side and plain on the other.
Danish: Blå, runde, bikonvekse, filmovertrukne tabletter - med ”D5” printet med blæk på den ene side og uden print på den anden side.
English: Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren Germany
Danish: Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren Tyskland
English: Tachycardia, palpitations QT prolongation
Danish: Takykardi, hjertebanken Forlænget QT-interval
English: OPA/Alu/PVC - Aluminium blisters.
Danish: OPA/Alu/pvc-aluminiumblisterpakninger.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTERPAKNING
English: Read the package leaflet before use.
Danish: Oral anvendelse Læs indlægssedlen inden brug.
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.
Danish: - Aktivt stof: 5 mg desloratadin - Øvrige indholdsstoffer: mikrokrystallinsk cellulose, prægelatineret majsstivelse, talcum, kolloid vandfri silica, lactosemonohydrat, hypromellose, titandioxid (E171), macrogol 400, indigotin (E132), shellac og propylenglycol.
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.
Danish: Hvorvidt amningen skal fortsættes eller om behandlingen med Desloratadine Teva 5 mg filmovertrukne tabletter skal seponeres/undlades skal vurderes ud fra afvejning af barnets fordele ved amning og kvindens fordele ved behandling.
English: Desloratadine Teva contains desloratadine which is an antihistamine.
Danish: Desloratadine Teva indeholder desloratadin, som er et antihistamin.
English: Merckle GmbH Ludwig-Merckle-Strasse 3 D-89143 Blaubeuren Germany
Danish: Merckle GmbH Ludwig-Merckle-Strasse 3 89143 Blaubeuren Tyskland
English: Tablet coating Lactose monohydrate Hypromellose Titanium dioxide (E171) Macrogol 400
Danish: Lactosemonohydrat Hypromellose Titandioxid (E171) Macrogol 400
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til din læge eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Package leaflet: Information for the patient Desloratadine Teva 5 mg film-coated tablets
Danish: Indlægsseddel : Information til patienten Desloratadine Teva 5 mg filmovertrukne tabletter
English: Titanium dioxide (E171) Propylene glycol
Danish: Titandioxid (E171) Propylenglycol.
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
Danish: ● øget hudfølsomhed over for sollys, selv i overskyet vejr, og over for ultraviolet (UV) lys, f.eks. UVlys i et solarium
English: Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea
Danish: Mavepine, kvalme, opkastning, dyspepsi, diarré
English: During the marketing of Desloratadine Teva, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely.
Danish: Under markedsføringen af Desloratadine Teva er der rapporteret meget sjældne tilfælde af alvorlige allergiske reaktioner (vejrtrækningsbesvær, hiven efter vejret, kløe, nældefeber og hævelse).