FrancophonIA/ELRC3.0 huggingface dataset:
English: Psychiatric disorders Uncommon:
Danish: Vaskulære sygdomme Ikke almindelig:
English: - Hypomagnesaemia
Danish: - Hypomagnesiæmi
English: NAME OF THE MEDICINAL PRODUCT Kinzalkomb 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
Danish: LÆGEMIDLETS NAVN Kinzalkomb 80 mg/25 mg tabletter telmisartan/hydrochlorthiazid
English: Kinzalkomb 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Danish: Kinzalkomb 80 mg/12,5 mg tabletter telmisartan/hydrochlorthiazid
English: Kinzalkomb 40 mg/12.5 mg tablets Red and white oval shaped two layer tablet of 5.2 mm engraved with the code number 'H4'.
Danish: Kinzalkomb 40 mg/12,5 mg tabletter Ovale 5,2 mm aflange tabletter i to lag, et rødt og et hvidt, hvori koden ”H4” er præget.
English: NAME OF THE MEDICINAL PRODUCT Kinzalkomb 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Danish: LÆGEMIDLETS NAVN Kinzalkomb 40 mg/12,5 mg tabletter telmisartan/hydrochlorthiazid
English: - Hypercalcaemia
Danish: - Hyperkalciæmi
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder: 80 mg telmisartan og 12,5 mg hydrochlorthiazid.
English: Aplastic anaemia, haemolytic anaemia, bone marrow failure, leukopenia, neutropenia, agranulocytosis,
Danish: Trombocytopeni (nogle gange med purpura) Aplastisk anæmi, hæmolytisk anæmi, knoglemarvssvigt, leukopeni, neutropeni, agranulocytose
English: Exacerbation or activation of systemic lupus erythematosus Metabolism and nutrition disorders Uncommon: Rare:
Danish: Forværring eller aktivering af systemisk lupus erythematosus
English: What Kinzalkomb is and what it is used for What you need to know before you take Kinzalkomb How to take Kinzalkomb
Danish: Det skal du vide, før du begynder at tage Kinzalkomb Sådan skal du tage Kinzalkomb Bivirkninger
English: Arthrosis, tendon pain
Danish: Takykardi, arytmi
English: NAME OF THE MEDICINAL PRODUCT Kinzalkomb 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Danish: LÆGEMIDLETS NAVN Kinzalkomb 80 mg/12,5 mg tabletter telmisartan/hydrochlorthiazid
English: Hypersensitivity, anaphylactic reactions Metabolism and nutrition disorders Uncommon: Rare:
Danish: Metabolisme og ernæring Ikke almindelig:
English: Thiazide diuretic-associated azotaemia may occur in patients with impaired renal function.
Danish: Hos patienter med nedsat nyrefunktion kan thiazid medføre azotæmi.
English: Tachycardia, arrhythmias
Danish: Artrose, senesmerter
English: Cases of interstitial lung disease have been reported from post-marketing experience in temporal association with the intake of telmisartan.
Danish: Efter markedsføring er der set tilfælde af interstitiel lungesygdom hos patienter i behandling med telmisartan uden at der dog er fastslået nogen årsagssammenhæng.
English: • Cholestasis and biliary obstructive disorders.
Danish: • Galdeophobning i galdegange og galdeobstruktion
English: Back pain, muscle spasms, myalgia Arthralgia, muscle cramps, pain in limb Reproductive system and breast disorders Uncommon:
Danish: Rygsmerter, muskelspasmer, myalgi Artralgi, muskelkramper, smerter i ekstremiteter
English: Infections and infestations
Danish: • Leversygdom
English: Restlessness
Danish: Rastløshed
English: In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of angiotensin II receptor antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Danish: Samtidig behandling med angiotensin II-receptorantagonister og stoffer der hæmmer cyklooxygenasen, kan medføre en yderligere svækkelse hos nogle patienter, der allerede har nedsat nyrefunktion (dehydrering, alder).
English: Muscoloskeletal, connective tissue and bone disorders Uncommon:
Danish: Knogler, led, musker og bindevæv Ikke almindelig:
English: Yellow and white oval shaped tablet of 6.2 mm engraved with the code 'H9'.
Danish: Ovale 6,2 mm aflange tabletter i to lag, et gult og et hvidt, hvori koden ”H9” præget på.
English: Telmisartan:
Danish: Fertilitet:
English: - Gout.
Danish: (se pkt.
English: Digitalis glycosides
Danish: Digitalisglykosider
English: Never take two doses on the same day.
Danish: Tag aldrig to doser på den samme dag.
English: Excretion Following administration of an oral [
Danish: Udskillelse Efter administration af en oral dosis [
English: Lipase increased**
Danish: Forhøjet lipase**
English: Children and adolescents Trajenta is not recommended for children and adolescents under 18 years.
Danish: Børn og unge Trajenta anbefales ikke til børn og unge under 18 år.
English: It is unknown if Trajenta is harmful to the unborn child.
Danish: Det vides ikke, om Trajenta er skadeligt for det ufødte barn.
English: Do not stop taking Trajenta without first consulting your doctor.
Danish: Du må ikke holde op med at tage Trajenta uden først at have rådført dig med din læge.
English: Body weight did not differ significantly between the groups.
Danish: Der var ingen signifikant forskel i kropsvægt mellem grupperne.
English: The clinical trials before marketing authorisation have been performed up to a BMI equal to 40 kg/m
Danish: De kliniske studier før markedsføringstilladelsen er gennemført hos personer med et BMI op til 40 kg/m
English: Your blood sugar levels may increase when you stop taking Trajenta.
Danish: Blodsukkerniveauet kan stige, hvis du holder op med at tage Trajenta.
English: Therefore, it is preferable to avoid using Trajenta if you are pregnant.
Danish: Derfor bør du undgå at bruge Trajenta, hvis du er gravid.
English: • have or have had a disease of the pancreas.
Danish: • har eller tidligere har haft sygdom i bugspytkirtlen.
English: STOP taking Trajenta and contact a doctor immediately if you notice any of the following serious side effects:
Danish: STOP med at tage Trajenta og kontakt din læge med det samme, hvis du bemærker en eller flere af følgende alvorlige bivirkninger:
English: Of these, 4.0% were mild and 0.9% were moderate and 0.1% were classified as severe in intensity.
Danish: Af disse blev 4,0 % klassificeret som lette, 0,9 % som moderate og 0,1 % som svære i intensitet.
English: You can take Trajenta with or without food.
Danish: Trajenta kan tages med eller uden mad.
English: Linagliptin and its main metabolite did not show a genotoxic potential.
Danish: Linagliptin og dets vigtigste metabolit viste ikke noget genotoksisk potentiale.
English: • If you forget to take a dose of Trajenta, take it as soon as you remember it.
Danish: • Hvis du har glemt at tage en dosis Trajenta, så tag den straks, du kommer i tanke om det.
English: Diabetic skin lesions are a common complication of diabetes.
Danish: Hudlæsioner er en almindelig komplikation ved diabetes.
English: There was no difference between groups in severe hypoglycaemic events.
Danish: Der var ingen forskel mellem grupperne i svære hypoglykæmiske tilfælde.
English: This was achieved with a stable insulin dose (40.1 IU).
Danish: Dette blev opnået med en stabil insulindosis (40,1 IE).
English: No teratogenic effects were observed in rabbits at >1,000 times human exposure.
Danish: Der blev ikke observeret nogen teratogene virkninger i kaniner ved > 1.000 gange den humane eksponering.
English: The tablets can be taken with or without a meal at any time of the day.
Danish: Tabletterne kan tages med eller uden mad på et vilkårligt tidspunkt af dagen.
English: • Common: level of lipase in the blood increased.
Danish: • Almindelige: Forhøjet indhold af lipase i blodet.
English: Do not use Trajenta if the package is damaged or shows signs of tampering.
Danish: Brug ikke Trajenta, hvis pakningen er beskadiget eller viser tegn på at være forsøgt åbnet.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager Trajenta.
English: If you experience any of the signs of illness mentioned above, stop taking Trajenta and call your doctor right away.
Danish: Hvis du oplever nogen af ovenstående tegn på sygdom, skal du holde op med at tage Trajenta og straks kontakte din læge.
English: Trajenta should not be used to treat these conditions.
Danish: Trajenta må ikke bruges til behandling af disse sygdomme
English: - The other ingredients are
Danish: - Øvrige indholdsstoffer:
English: Trajenta contains the active substance linagliptin which belongs to a group of medicines called “oral anti-diabetics”.
Danish: Trajenta indeholder det aktive stof linagliptin, som tilhører en klasse af lægemidler, som kaldes ”orale antidiabetika”.
English: Some patients have had the following side effects while taking Trajenta alone or in combination with other medicinal products for the treatment of diabetes:
Danish: Nogle patienter har oplevet følgende bivirkninger, når de har taget Trajenta alene eller i kombination med andre lægemidler til behandling af sukkersyge:
English: Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis.
Danish: Brugen af DPP-4-hæmmere er forbundet med risiko for udvikling af akut pankreatitis.
English: Doses of background antidiabetic medicinal products were kept stable during the first 12 weeks, after which adjustments were permitted.
Danish: Dosis af den antidiabetiske baggrundsbehandling blev holdt stabil gennem de første 12 uger, hvorefter dosisjustering var tilladt.
English: Higher baseline HbA1c was associated with a greater reduction in HbA1c.
Danish: Højere baseline-HbA1c var forbundet med en større reduktion i HbA1c.
English: Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Danish: Linagliptin bør ikke anvendes til patienter med type 1-diabetes eller til behandling af diabetisk ketoacidose.
English: Film coating Hypromellose Titanium dioxide (E171) Talc
Danish: Filmovertræk Hypromellose Titandioxid (E171) Talcum
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 August 2011
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 24. august 2011 Dato for seneste fornyelse: 22. marts 2016
English: These studies had 929 patients of 65 years and over who were on linagliptin.
Danish: I disse studier var 929 patienter i alderen 65 år og derover i behandling med linagliptin.
English: Thus, full efficacy of linagliptin in combination with strong P-gp inducers might not be achieved, particularly if these are administered long-term.
Danish: Derfor opnås muligvis ikke en fuld virkning af linagliptin i kombination med potente P-gp-induktorer, især ikke ved langvarig behandling.
English: There was a significant difference in reduction in HbA1c between Asian patients (0.8%) and White patients (0.5%) in the pooled studies.
Danish: Der var en signifikant forskel i reduktionen i HbA1c mellem asiatiske patienter (0,8 %) og hvide patienter (0,5 %) i de poolede studier.
English: A significantly higher incidence of malignant lymphomas only in female mice at the highest dose (> 200 times human exposure) is not considered relevant for humans (explanation: nontreatment related but due to highly variable background incidence).
Danish: En signifikant højere incidens af maligne lymfomer udelukkende hos hunmus ved den højeste dosis (> 200 gange human eksponering) betragtes ikke som relevant for mennesker (forklaring: ikke-behandlingsrelateret, men skyldes baggrundsincidens med stor variabilitet).
English: There was no increased risk in hospitalization for heart failure which was an additional adjudicated endpoint observed compared to usual care without linagliptin in patients with type 2 diabetes (see table 2).
Danish: Der var ingen øget risiko for indlæggelse for hjertesvigt, hvilket var et ekstra adjudikeret endepunkt, som blev observeret, sammenlignet med sædvanlig behandling uden linagliptin hos patienter med type 2diabetes (se tabel 2).
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) or not known (cannot be estimated from the available data).
Danish: Bivirkningerne er opdelt efter hyppighed: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If pancreatitis is suspected, Trajenta should be discontinued; if acute pancreatitis is confirmed, Trajenta should not be restarted.
Danish: Hvis der er mistanke om pankreatitis, skal Trajenta seponeres: hvis akut pankreatitis bekræftes, må behandling med Trajenta ikke påbegyndes igen.
English: The reductions in glycosylated haemoglobin A1c (HbA1c) were similar across different subgroups including gender, age, renal impairment and body mass index (BMI).
Danish: Reduktionen i glykeret hæmoglobin A1c (HbA1c) var ensartet på tværs af forskellige undergrupper, herunder køn, alder, nedsat nyrefunktion og body mass index (BMI).
English: Your doctor may ask you to stop Trajenta.
Danish: Din læge kan beslutte, at du skal stoppe med at tage Trajenta.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS (PERFORATED)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTRE (PERFOREREDE)
English: In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring and institute clinical measures if required.
Danish: I tilfælde af en overdosis er det hensigtsmæssigt at benytte de sædvanlige understøttende foranstaltninger såsom at fjerne ikke absorberet lægemiddel fra mave-tarmkanalen, klinisk monitorering og om nødvendigt, at igangsætte kliniske foranstaltninger.
English: Sulphonylureas and insulin are known to cause hypoglycaemia.
Danish: Sulfonylurinstoffer og insulin er kendt for at forårsage hypoglykæmi.
English: Incretins are secreted at a low basal level throughout the day and levels rise immediately after meal intake.
Danish: Inkretiner secerneres i dagtimerne resulterende i et lavt basisniveau, der øges umiddelbart efter et måltid.
English: When linagliptin is added to metformin, the dose of metformin should be maintained, and linagliptin administered concomitantly.
Danish: Når linagliptin anvendes i tillæg til metformin, bør dosis af metformin opretholdes, og linagliptin administreres samtidigt.
English: The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Danish: Brug ikke Trajenta efter den udløbsdato, der står på blisterkort og pakning.
English: Based on these results and in vivo interaction studies, linagliptin is considered unlikely to cause interactions with other P-gp substrates.
Danish: På baggrund af disse resultater og in vivo-studier af lægemiddelinteraktioner anses det for usandsynligt, at linagliptin interagerer med andre P-gp-substrater.
English: During controlled clinical trials in healthy subjects, single doses of up to 600 mg linagliptin (equivalent to 120 times the recommended dose) were generally well tolerated.
Danish: I kontrollerede kliniske studier hos raske frivillige var enkeltdoser på op til 600 mg linagliptin (svarende til 120 gange den anbefalede dosis) generelt veltolererede.
English: • have type 1 diabetes (your body does not produce any insulin) or diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting).
Danish: • har type 1-diabetes (din krop danner ikke insulin) eller diabetisk ketoacidose (en følgesygdom til diabetes som medfører højt blodsukkerniveau, hurtigt vægttab, kvalme eller opkastning).
English: • Rare: blistering of skin (bullous pemphigoid).
Danish: • Sjælden: Blæredannelse på huden (bulløs pemfigoid).
English: Most patients (80.5%) received insulin as background therapy, alone or in combination with other oral anti-diabetics such as sulphonylurea, glinide and pioglitazone.
Danish: De fleste patienter (80,5 %) fik insulin som baggrundsbehandling enten alene eller i kombination med orale antidiabetika såsom sulfonylurinstof, glinid eller pioglitazon.
English: If you stop taking Trajenta
Danish: Hvis du holder op med at tage Trajenta
English: Linagliptin once daily produced clinically significant improvements in glycaemic control, with no clinically relevant change in body weight.
Danish: Linagliptin givet én gang dagligt medførte klinisk signifikante forbedringer i glykæmisk kontrol uden klinisk relevant ændring af kropsvægten.
English: For any information about this medicine, please contact the local representatives of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Trajenta, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Therefore, linagliptin is not an inhibitor of OCT-mediated transport.
Danish: Linagliptin er derfor ikke en inhibitor af OCT-medieret transport.
English: • Uncommon: inflamed nose or throat (nasopharyngitis), cough, constipation (in combination with insulin), level of amylase in the blood increased.
Danish: • Ikke almindelige: Betændelse i næse eller svælg (nasofaryngit), hoste, forstoppelse (i kombination med insulin), forhøjet indhold af amylase i blodet.
English: Table 2 Cardiovascular and renal outcomes by treatment group in the CARMELINA study
Danish: Tabel 2 Kardiovaskulære og renale endepunkter pr. behandlingsgruppe i CARMELINA-studiet
English: “D5” on one side and the Boehringer Ingelheim logo on the other.
Danish: "D5" på den ene side og firmalogo på den anden.
English: The safety and efficacy of linagliptin in children and adolescents has not yet been established.
Danish: Pædiatrisk population Linagliptins sikkerhed og virkning hos børn og unge er endnu ikke klarlagt.
English: Tablet core: Mannitol, pregelatinised starch (maize), maize starch, copovidone, magnesium stearate
Danish: Tabletkerne: Mannitol, pregelatineret stivelse (majs), majsstivelse, copovidon, magnesiumstearat
English: If you forget to take Trajenta
Danish: Hvis du har glemt at tage Trajenta
English: Simulations of steady-state plasma concentrations of linagliptin with and without ritonavir indicated that the increase in exposure will be not associated with an increased accumulation.
Danish: Simulationer af steady state-plasmakoncentrationer af linagliptin, med og uden samtidig administration af ritonavir, tydede på, at øget eksponering ikke er forbundet med øget akkumulering.
English: The dose of linagliptin is 5 mg once daily.
Danish: Dosis af linagliptin er 5 mg én gang dagligt.
English: Available pharmacokinetic data in animals have shown excretion of linagliptin/metabolites in milk.
Danish: De tilgængelige farmakokinetiske data fra dyrestudier viser, at linagliptin/metabolitter udskilles i mælk.
English: It is not known if Trajenta passes into human breast milk.
Danish: Det vides ikke, om Trajenta går over i mælk.
English: After a median follow up of 6.25 years, linagliptin did not increase the risk of major adverse cardiovascular events (see table 3) as compared to glimepiride.
Danish: Efter en median opfølgning på 6,25 år øgede linagliptin ikke risikoen for større kardiovaskulære hændelser (se tabel 3), sammenlignet med glimepirid.
English: This is an antibiotic used to treat infections such as tuberculosis.
Danish: • Rifampicin - et antibiotikum, der bruges til behandling af infektioner såsom tuberkulose.
English: Trajenta is used for ‘type 2 diabetes' in adults, if the disease cannot be adequately controlled with one oral anti-diabetic medicine (metformin or sulphonylureas) or diet and exercise alone.
Danish: Trajenta bruges ved type 2-diabetes hos voksne, når sygdommen ikke kan kontrolleres tilstrækkeligt med et oralt diabeteslægemiddel (metformin eller sulfonylurinstof) eller udelukkende med diæt og motion.
English: There was a further follow up 40 week treatment period during which dose adjustments in antidiabetes background therapies were allowed.
Danish: I en yderligere opfølgningsperiode på 40 uger var dosisjustering af den antidiabetiske baggrundsbehandling tilladt.
English: Skin and subcutaneous tissue disorders Angioedema*
Danish: Hud og subkutane væv Angioødem*
English: Pharmacokinetic studies suggest that no dose adjustment is required for patients with hepatic impairment but clinical experience in such patients is lacking.
Danish: Farmakokinetiske studier tyder på, at dosisjustering ikke er nødvendig hos patienter med nedsat leverfunktion, men der mangler klinisk erfaring.
English: No studies on the effect on human fertility have been conducted for linagliptin.
Danish: Der er ikke gennemført studier af linagliptins virkning på human fertilitet.
English: Oral 2 year carcinogenicity studies in rats and mice revealed no evidence of carcinogenicity in rats or male mice.
Danish: 2-årige, orale karcinogenicitetsstudier i rotter og mus viste ikke nogen evidens for karcinogenicitet hos rotter eller hanmus.
English: After a median follow up of 2.2 years, linagliptin, when added to usual care, did not increase the risk of major adverse cardiovascular events or renal outcome events.
Danish: Efter en median opfølgning på 2,2 år øgede linagliptin, når det blev tilføjet til den sædvanlige behandling, ikke risikoen for større uønskede kardiovaskulære hændelser eller renale hændelser.
English: There were also 1,238 patients with mild renal impairment, and 143 patients with moderate renal impairment on linagliptin.
Danish: Desuden blev 1.238 patienter med let nedsat nyrefunktion og 143 patienter med moderat nedsat nyrefunktion behandlet med linagliptin.
English: Older subjects (65 to 80, oldest patient was 78 years) had comparable plasma concentrations of linagliptin compared to younger subjects.
Danish: Ældre (65 til 80 år, de ældste patienter var 78 år) og yngre havde sammenlignelige plasmakoncentrationer af linagliptin.
English: C] linagliptin oral 10 mg dose, approximately 5% of the radioactivity was excreted in urine.
Danish: C]-linagliptin 10 mg dosis blev ca. 5 % af radioaktiviteten udskilt med urinen.
English: Film coating: Hypromellose, titanium dioxide (E171), talc, macrogol (6000), iron oxide red (E172)
Danish: Filmovertræk: Hypromellose, titandioxid (E171), talcum, macrogol (6.000), rød jernoxid (E172)
English: It is important to keep following the advice about diet and exercise that you have been given by your doctor or nurse.
Danish: Du skal fortsat følge de råd om diæt og motion, som lægen eller sygeplejersken har givet.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with linagliptin in one or more subsets of the paediatric population in Type 2 diabetes (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med linagliptin i en eller flere undergrupper af den pædiatriske population ved type 2-diabetes (se pkt.
English: The incidence of hypoglycaemia in the linagliptin group (7.5%) was significantly lower than that in the glimepiride group (36.1%).
Danish: Incidensen af hypoglykæmi i linagliptingruppen (7,5 %) var signifikant lavere end incidensen i glimepiridgruppen (36,1 %).