FrancophonIA/ELRC3.0 huggingface dataset:
English: CV mortality and all cause mortality were numerically higher with the combination.
Danish: Kardiovaskulær død eller død af andre årsager var numerisk højere ved kombinationen.
English: Dose-relationship of adverse reactions was not established and they showed no correlation with gender, age or race of the patients.
Danish: Bivirkninger var ikke dosisrelaterede og viste ingen korrelation med patienternes køn, alder eller race.
English: Kinzalkomb with food and alcohol
Danish: Brug af Kinzalkomb sammen med mad og alkohol
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/214/011-015
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/02/214/011-015
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Danish: Dobbelthæmning af renin-angiotensin-aldosteronsystemet (RAAS)
English: - The active ingredient hydrochlorothiazide can cause an unusual reaction, resulting in a decrease in vision and eye pain.
Danish: • Det aktive indholdsstof hydrochlorthiazid kan være årsag til en usædvanlig reaktion, hvilket kan resultere i synsnedsættelse og øjensmerter.
English: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Kinzalkombs” and “Warnings and precautions”).
Danish: - Hvis du samtidig tager en ACE-hæmmer eller aliskiren - se også information under overskriften ”Tag ikke Kinzalkomb” og ”Advarsler og forsigtighedsregler”.
English: Telmisartan is metabolised by conjugation to form a pharmacologically inactive acylglucuronide.
Danish: Telmisartan metaboliseres ved konjugering, hvor der dannes et farmakologisk inaktivt acylglucuronid.
English: If you forget to take Kinzalkomb
Danish: Hvis du har glemt at tage Kinzalkomb
English: Talk to your doctor before taking Kinzalkomb:
Danish: Kontakt lægen, før du tager Kinzalkomb:
English: This medicine does not require any special temperature storage conditions.
Danish: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringstemperatur.
English: Furthermore, orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics or antidepressants.
Danish: Endvidere kan ortostatisk hypotension forværres af alkohol, barbiturater, narkotika eller antidrepessiva.
English: Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
Danish: Telmisartan displacerer angiotensin II med meget høj affinitet fra dets bindingssted på AT1-receptorsubtypen, som er ansvarlig for de kendte virkninger af angiotension II.
English: Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin.
Danish: Telmisartan hæmmer ikke "angiotensin-convertingenzyme" (kininase-II-enzymet), som også nedbryder bradykinin.
English: The safety and efficacy of Kinzalkomb in children and adolescents aged below 18 have not been established.
Danish: Kinzalkombs sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: When clinically appropriate, direct change from monotherapy to the fixed combination may be considered
Danish: Hvis det er klinisk relevant, kan et direkte skift fra monoterapi til den faste kombination overvejes.
English: Kinzalkomb once daily produces effective and smooth reductions in blood pressure across the therapeutic dose range.
Danish: Kinzalkomb administreret én gang dagligt giver en effektiv og jævn reduktion i blodtrykket i hele det terapeutiske dosisinterval.
English: Take it as soon as you remember then carry on as before.
Danish: Hvis du glemmer at tage medicinen, skal du tage den straks du kommer i tanke om det, og derefter fortsætte som du plejer.
English: Elderly Pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years.
Danish: Ældre Der er ingen forskelle med hensyn til telmisartans farmakokinetik hos personer over eller under 65 år.
English: Marked hypercalcaemia may be evidence of hidden hyperparathyroidism.
Danish: Tydelig hyperkalciæmi kan være et tegn på skjult hyperparatyroidisme.
English: Adverse reactions of unknown frequency reported with the use of hydrochlorothiazide alone include: Infections and infestations
Danish: Følgende bivirkninger af ukendt hyppighed er rapporteret ved brug af hydrochlorthiazid alene: Infektioner og parasitære sygdomme
English: Pressor amines (e.g. noradrenaline)
Danish: Pressor-aminer (fx noradrenalin)
English: Kinzalkomb can have influence on the ability to drive and use machines.
Danish: Kinzalkomb kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: • Second and third trimesters of pregnancy (see sections 4.4 and 4.6).
Danish: • Andet og tredje trimester af graviditeten (se pkt.
English: Metformin should be used with precaution: risk of lactic acidosis induced by a possible functional renal failure linked to hydrochlorothiazide.
Danish: Metformin skal bruges med forsigtighed: Risikoen for laktacidose forårsaget af et muligt funktionelt nyresvigt i forbindelse med hydrochlorthiazid.
English: The effects of fixed dose combination of telmisartan/HCTZ on mortality and cardiovascular morbidity are currently unknown.
Danish: Effekten af en fastdosiskombination af telmisartan/hydrochlorthiazid på dødelighed og kardiovaskulær morbiditet er indtil videre ukendt.
English: Respiratory distress (including pneumonitis and pulmonary oedema)
Danish: Dyspnø Åndedrætsbesvær (inklusive pneumonit og lungeødem)
English: Occasionally, the outer layer of the blister pack separates from the inner layer between the blister pockets.
Danish: Det er lejlighedsvis set, at det ydre lag af blisterpakningen løsner sig fra det indre lag mellem blisterlommerne.
English: Telmisartan is an orally effective and specific angiotensin II receptor subtype 1 (AT1) antagonist.
Danish: Telmisartan er en oralt administreret effektiv specifik angiotensin II-receptorsubtype 1(AT1)antagonist.
English: Anxiety Depression
Danish: Angst Depression
English: The European Medicines Agency has waived the obligation to submit the results of studies with Kinzalkomb in all subsets of the paediatric population in hypertension (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Kinzalkomb i alle undergrupper af den pædiatriske population med hypertension (se pkt.
English: Kinzalkomb is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet.
Danish: Kinzalkomb er en kombination af to aktive stoffer - telmisartan og hydrochlorthiazid - i én tablet.
English: The all-cause mortality rate was 11.6 % and 11.8 % among telmisartan and ramipril treated patients, respectively.
Danish: Død af alle årsager var 11,6 % henholdsvis 11,8 % for telmisartan- og ramiprilbehandlede patienter.
English: In a follow-up trial with the 80 mg/25 mg combination, blood pressure was further decreased (resulting in an overall reduction of 11.5/9.9 mm Hg (SBP/DBP).
Danish: I et opfølgningsstudie med 80 mg/25 mg kombination sås en yderligere reduktion af blodtrykket (resulterende i en samlet reduktion på 11,5/9,9 mm Hg (SBP/DBP).
English: Telmisartan: Following oral administration peak concentrations of telmisartan are reached in 0.5 - 1.5 h after dosing.
Danish: Telmisartan: Ved oral administration opnås peak-koncentrationerne af telmisartan i løbet af 0,5-1,5 time efter indgift.
English: Reduction in blood platelets, which increases risk of bleeding or bruising (small purple-red marks in skin or other tissue caused by bleeding), high blood calcium level, headache.
Danish: Reduktion i blodplader, som øger risikoen for blødning eller blå mærker (små lilla-røde mærker på huden eller andet væv forårsaget af blødning), højt calciumindhold i blodet, hovedpine.
English: The hazard ratio for telmisartan vs. ramipril was 1.01 (97.5 % CI 0.931.10, p (non-inferiority) = 0.0019 at a margin of 1.13).
Danish: Hazard ratio for telmisartan vs. ramipril var 1,01 (97,5 % CI 0,93-1,10; p (non-inferioritet) = 0,0019 ved en margin på 1,13).
English: Hydrochlorothiazide: Following oral administration of Kinzalkomb peak concentrations of hydrochlorothiazide are reached in approximately 1.0 - 3.0 hours after dosing.
Danish: Hydrochlorthiazid: Ved oral administration af Kinzalkomb nås peak-koncentrationerne af hydrochlorthiazid i løbet af 1,0-3,0 time efter indgift.
English: Remove your Kinzalkomb tablet from the blister only directly prior to intake.
Danish: Tag først din Kinzalkomb-tablet ud af blisteren lige før indtagelse.
English: Therefore, in these patients blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required, when indicated.
Danish: Derfor bør monitorering af glucose hos disse patienter overvejes, og en dosisjustering af insulin eller antidiabetika kan være nødvendig.
English: Investigations Not known:
Danish: Undersøgelser Ikke kendt:
English: Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
Danish: Absorptionen af hydrochlorthiazid svækkes ved tilstedeværelsen af anioniske resiner.
English: These could be symptoms of an increase of pressure in your eye and can happen within hours to weeks of taking Kinzalkomb.
Danish: Dette kan være symptomer på forhøjet tryk i øjet og kan udvikles indenfor få timer til uger, efter behandling med Kinzalkomb er startet.
English: Kinzalkomb contains milk sugar (lactose) and sorbitol.
Danish: Kinzalkomb indeholder mælkesukker (laktose) og sorbitol.
English: 3: For further description, please see sub-section“Description of selected adverse reactions” Hydrochlorothiazide:
Danish: 3: For yderligere beskrivelse, se underpunktet ”Beskrivelse af udvalgte bivirkninger” Hydrochlorthiazid:
English: An 80 mg dose of telmisartan administered to healthy volunteers almost completely inhibits the angiotensin II evoked blood pressure increase.
Danish: En dosis på 80 mg telmisartan givet til raske frivillige hæmmer næsten fuldstændigt en angiotensin IIprovokeret blodtryksforhøjelse.
English: In addition, Kinzalkomb should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Danish: Desuden skal Kinzalkomb anvendes med forsigtighed til patienter med nedsat leverfunktion eller progredierende leversygdom, idet små forskydninger i væske- og elektrolytbalancen kan udløse hepatisk coma.
English: The cytochrome P450 isoenzymes are not involved in the metabolism of telmisartan.
Danish: CYP-isoenzymer er ikke involveret i metaboliseringen af telmisartan.
English: Telmisartan selectively binds the AT1 receptor.
Danish: Telmisartan bindes selektivt til AT1receptoren.
English: Hydrochlorothiazide should not be used for gestational oedema, gestational hypertension or preeclampsia due to the risk of decreased plasma volume and placental hypoperfusion, without a beneficial effect on the course of the disease.
Danish: Hydrochlorthiazid bør ikke bruges mod graviditetsødem, forhøjet blodtryk under graviditet eller præeklampsi på grund af risikoen for nedsat plasmavolumen og placental hypoperfusion uden gavnlig virkning på sygdomsforløbet.
English: In functionally anephric patients the elimination half-life is about 34 hours.
Danish: Hos patienter med totalt manglende nyrefunktion er elimineringshalveringstiden ca. 34 timer.
English: • Hypersensitivity to other sulphonamide-derived substances (since hydrochlorothiazide is a sulphonamide-derived medicinal product).
Danish: • Overfølsomhed over for andre derivater af sufonamid (hydrochlorthiazin er et sulfonamidderivat)
English: In a typical study in patients with a mean creatinine clearance of 90 ml/min the elimination half-life of hydrochlorothiazide was increased.
Danish: I et typisk forsøg med patienter med en middel kreatinin-clearance på 90 ml/min, var elimineringshalveringstiden for hydrochlorthiazid øget.
English: Hydrochlorothiazide is 68 % protein bound in the plasma and its apparent volume of distribution is 0.83 - 1.14 l/kg.
Danish: 68% af hydrochlorthiazidet er bundet i plasma, og det tilsyneladende fordelingsvolumen er 0,83-1,14 l/kg.
English: Thiazides have an effect on the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts.
Danish: Thiaziderne påvirker den renale tubulære mekanisme, der styrer elektrolytreabsorption, med en direkte øgning af udskillelsen af natrium og klorid i omtrent lige store mængder.
English: Therefore the combination should be administered with caution, especially in the elderly.
Danish: Derfor bør samtidig behandling foregå under nøje overvågning, især af ældre patienter.
English: Latent diabetes mellitus may become manifest during thiazide therapy.
Danish: En latent diabetes mellitus kan eventuelt blive manifest ved thiazidbehandling.
English: Kinzalkomb may be less effective in lowering the blood pressure in black patients.
Danish: Kinzalkomb kan have en mindre blodtrykssænkende virkning hos sorte patienter.
English: If you accidentally take too many tablets you may experience symptoms such as low blood pressure and rapid heartbeat.
Danish: Hvis du har taget for mange Kinzalkomb tabletter Hvis du har taget for mange tabletter, kan du få symptomer såsom lavt blodtryk og hjertebanken.
English: A cumulative dose-response relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100,000 mg) (see also section 4.4).
Danish: Der blev påvist en kumulativ dosis/respons relation med en justeret OR-værdi på 2,1 (95 %-KI: 1,7-2,6), der steg til OR 3,9 (3,04,9) ved et stort forbrug (~25.000 mg) og OR 7,7 (5,7-10,5) ved den højeste kumulative dosis (~100.000 mg) (se også pkt.
English: Precautions to be taken before handling or administering the medicinal product Kinzalkomb should be kept in the sealed blister due to the hygroscopic property of the tablets.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet Kinzalkomb skal forblive i den forseglede blister pga. hygroskopiske egenskaber.
English: Tell your doctor if you are breast-feeding or about to start breast-feeding.
Danish: Fortæl lægen, hvis du ammer eller vil starte på at amme.
English: This is confirmed by measurements made at the point of maximum effect and immediately prior to the next dose (through to peak ratios consistently above 80 % after doses of 40 and 80 mg of telmisartan in placebo controlled clinical studies).
Danish: Dette er bekræftet ved målinger, der blev foretaget på tidspunktet for maksimal effekt og umiddelbart forud for den næste dosis (trough/peak ratio var over 80% efter dosering af 40 mg og 80 mg telmisartan i alle placebokontrollerede kliniske forsøg).
English: If your liver is not working properly, the usual dose should not exceed 40 mg/12.5 mg once a day.
Danish: Hvis din leverfunktion er nedsat, bør dosis ikke være højere end 40 mg/12,5 mg én gang om dagen.
English: The antihypertensive efficacy of telmisartan is comparable to that of agents representative of other classes of antihypertensive medicinal products (demonstrated in clinical trials comparing telmisartan to amlodipine, atenolol, enalapril, hydrochlorothiazide, and lisinopril).
Danish: Telmisartans antihypertensive virkning er sammenlignelig med effekten af andre klasser af antihypertensiva (påvist i kliniske forsøg, der sammenlignede telmisartan med amlodipin, atenolol, enalapril, hydrochlorthiazid og lisinopril).
English: Hydrochlorothiazide is not metabolised in man.
Danish: Hydrochlorthiazid metaboliseres ikke.
English: Such conditions should be corrected before the administration of Kinzalkomb.
Danish: Sådanne tilstande bør korrigeres, før behandling med Kinzalkomb initieres.
English: Kinzalkomb should be kept in the sealed blister due to the hygroscopic property of the tablets.
Danish: Kinzalkomb skal opbevares i den forseglede blister på grund af tabletternes hygroskopiske egenskaber.
English: Experience with Kinzalkomb is modest in the patients with mild to moderate renal impairment, therefore periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Danish: Erfaringer med Kinzalkomb er begrænsede hos patienter med let til moderat nedsat nyrefunktion, og derfor anbefales periodisk kontrol af serumværdierne for kalium, kreatinin og urinsyre.
English: In dogs renal tubular dilation and atrophy were observed.
Danish: I hunde blev der observeret tubulær dilatation og atrofi af nyrene.
English: The overall incidence of adverse reactions reported with telmisartan (41.4 %) was usually comparable to placebo (43.9 %) in placebo controlled trials.
Danish: I placebo-kontrollerede forsøg var den samlede forekomst af bivirkninger, som blev rapporteret i forbindelse med telmisartan (41,4 %) sædvanligvis sammenlignelig med placebo (43,9 %).
English: Sorbitol and Lactose Monohydrate
Danish: Sorbitol og lactosemonohydrat
English: If any of the above applies to you, tell your doctor or pharmacist before taking Kinzalkomb.
Danish: Hvis et af ovennævnte punkter gælder for dig, skal du tale med din læge eller apoteket om det, inden du tager Kinzalkomb.
English: Adverse reactions known to occur with each component given singly but which have not been seen in clinical trials may occur during treatment with Kinzalkomb.
Danish: Bivirkninger, der er kendt for de enkelte komponenter, men som ikke er forekommet i de kliniske forsøg, kan forekomme ved behandling med Kinzalkomb.
English: • if your doctor determines that you have low potassium levels or high calcium levels in your blood that do not get better with treatment.
Danish: • hvis din læge i en blodprøve finder for lavt indhold af kalium eller for højt indhold af calcium og dette ikke bedres ved behandling
English: In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the AUC0-24 and Cmax of ramipril and ramiprilat.
Danish: I et forsøg medførte samtidig administration af telmisartan en stigning i AUC0-24 og Cmax af ramipril og ramiprilat på op til 2,5 gange.
English: Slow heartbeat, dizziness, vomiting, reduced kidney function including kidney failure, have also been reported.
Danish: Langsom puls, svimmelhed, opkastning, nedsat nyrefunktion, herunder nyresvigt, er også rapporteret.
English: In case of surgery or anaesthetics, you should tell your doctor that you are taking Kinzalkomb.
Danish: Før en operation eller bedøvelse bør du fortælle din læge, at du tager Kinzalkomb.
English: If calcium supplements or calcium sparing medicinal products (e.g. vitamin D therapy) must be prescribed, serum calcium levels should be monitored and calcium dosage adjusted accordingly.
Danish: Hvis der gives calciumsupplement eller calciumbesparende lægemidler (fx D-vitamin), skal serumcalcium monitoreres og calciumdoseringen justeres herefter.
English: Your doctor will normally advise you to stop taking Kinzalkomb before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Kinzalkomb.
Danish: Normalt vil din læge anbefale dig at stoppe med at tage Kinzalkomb, før du bliver gravid eller så snart du ved, du er gravid.
English: Treatment with hydrochlorothiazide may cause electrolyte imbalance in your body.
Danish: Behandling med hydrochlorthiazid kan forårsage ændringer i kroppens saltbalance.
English: Thiazides should be used with caution in patients with impaired hepatic function (see section 4.4).
Danish: Thiazider skal anvendes med forsigtighed hos patienter med nedsat leverfunktion (se pkt.
English: Hyperkalaemia Hypoglycaemia (in diabetic patients)
Danish: Hyperkaliæmi Hypoglykæmi (hos diabetes patienter)
English: The event may be a chance finding or related to a mechanism currently not known (see section 5.1).
Danish: Observationen kan være en tilfældighed eller relateret til en mekanisme, som på nuværende tidspunkt ikke er kendt (se også pkt.
English: This medicinal product does not require any special temperature storage conditions.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringstemperatur.
English: The active substances are telmisartan and hydrochlorothiazide.
Danish: Aktive stoffer: Telmisartan og hydrochlorthiazid.
English: Rare cases have also been reported with angiotensin II receptor antagonists (including Kinzalkomb).
Danish: I sjældne tilfælde er dette også set ved behandling med angiotensin II-receptorantagonister (som Kinzalkomb).
English: Kinzalkomb tablets are for once-daily oral administration and should be taken with liquid, with or without food.
Danish: Kinzalkomb tabletter administreres oralt én gang daglig med væske, med eller uden mad.
English: Total plasma clearance of telmisartan after oral administration is >1500 ml/min.
Danish: Telmisartans totale plasmaclearance efter oral administration er >1.500 ml/min Den terminale eliminationshalveringstid var >20 timer.
English: Possible side effects of Kinzalkomb:
Danish: Bivirkninger ved Kinzalkomb:
English: Cytotoxic agents (e.g. cyclophosphamide, methotrexate)
Danish: Cytotoksiske lægemidler (fx cyclophosphamid, methotrexat)
English: Dosage adjustment of the antidiabetic medicinal products may be required (see section 4.4).
Danish: Dosisjustering af antidiabetika kan blive nødvendig (se pkt.
English: Antidiabetic medicinal products (oral agents and insulin)
Danish: Antidiabetika (orale præparater og insuliner)
English: Medicinal products used in the treatment for gout (e.g. probenecid, sulfinpyrazone and allopurinol) Dosage adjustment of uricosuric medications may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Danish: Lægemidler, der anvendes til behandling af urinsyregigt (fx probenecid, sulfinpyrazon og allopurinol) Dosisjustering af urikosuriske midler kan være nødvendig, idet hydrochlorthiazid kan øge serumurinsyre.
English: Therefore, the use of Kinzalkomb is not recommended.
Danish: Derfor frarådes brug af Kinzalkomb.
English: Based on the pharmacological mechanism of action of hydrochlorothiazide its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia.
Danish: Baseret på hydrochlorthiazids farmakologiske virkningsmekanisme kan brug i andet og tredje trimester kompromittere den føtoplacentale perfusion og forårsage føtale og neonatale bivirkninger såsom ikterus, forstyrrelser i elektrolytbalancen og trombocytopeni.
English: • Refractory hypokalaemia, hypercalcaemia.
Danish: • Refraktær hypokaliæmi, hyperkalcæmi.
English: • Hypersensitivity to any of the active substances or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for de aktive stoffer eller over for ét eller flere af hjælpestofferne anført i pkt.
English: The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia, dizziness, vomiting, increase in serum creatinine, and acute renal failure have also been reported.
Danish: De mest udtalte symptomer ved telmisartan-overdosering var hypotension og takykardi; også bradykardi, svimmelhed, opkastning, forhøjelse i serum-kreatinin og akut nyresvigt er set.
English: Thiazide diuretics may increase serum calcium levels due to the decreased excretion.
Danish: Thiaziddiuretika kan øge serumkalciumniveauet på grund af nedsat udskillelse.
English: Risk factors for developing acute angleclosure glaucoma may include a history of sulfonamide or penicillin allergy.
Danish: Risikofaktorer for udvikling af akut snævervinklet glaukom kan være kendt sulfonamid- eller penicillinallergi.
English: Electrolyte imbalance
Danish: Forstyrrelser i elektrolytbalancen