FrancophonIA/ELRC3.0 huggingface dataset:
English: Abrupt discontinuation of ramipril does not produce a rapid and excessive rebound increase in blood pressure.
Danish: Pludseligt ophør med ramipril giver ikke et hurtigt og excessivt tilbageslag med stigning i blodtryk til følge.
English: The CHMP also noted the importance to insert a paragraph regarding cough in line with the warning of previously harmonised ACE-I, therefore agreed the following: “Cough has been reported with the use of ACE inhibitors.
Danish: CHMP bemærkede desuden, at det er vigtigt at få indført et afsnit om hoste i overensstemmelse med advarslen i forbindelse med de tidligere harmoniserede ACE-hæmmere, og vedtog derfor følgende: "Der er rapporteret hoste ved brug af ACE-hæmmere.
English: There is a risk of impairment of renal function, particularly in patients with congestive heart failure or after renal transplant.
Danish: Der er risiko for nedsat nyrefunktion, særligt hos patienter med kongestiv hjerteinsufficiens eller efter nyretransplantation.
English: • Carbamazepine (for epilepsy).
Danish: • Carbamazepin (mod epilepsi)
English: TRITAZIDE is used to treat high blood pressure.
Danish: TRITAZIDE anvendes ved forhøjet blodtryk.
English: Some adverse effects (e.g. symptoms of a reduction in blood pressure such as dizziness) may impair the patient's ability to concentrate and react and, therefore, constitute a risk in situations where these abilities are of particular importance (e.g. operating a vehicle or machinery).
Danish: Visse bivirkninger (f.eks. nogle symptomer på reduktion af blodtryk så som uklarhed og svimmelhed) kan påvirke evnen til koncentrere sig og reagere, og udgør derfor en risiko i situationer hvor disse evner er særligt vigtige (f.eks.ved betjening af motorkøretøj eller betjening af maskiner i mindre eller moderat grad.).
English: • Flushing, fainting, hypotension (abnormally low blood pressure), especially when you stand or sit up quickly
Danish: Rødmen, besvimelse, hypotension (unormalt lavt blodtryk), specielt når du rejser eller sætter dig hurtigt op
English: Since angiotensin II also stimulates the release of aldosterone, ramiprilat causes a reduction in aldosterone secretion.
Danish: Da angiotensin II også stimulerer frigivelsen af aldosteron, forårsager ramiprilat en reduktion i aldosteronfrigivelsen.
English: Metabolic and endocrine effects
Danish: Metaboliske og endokrine påvirkninger
English: If such treatment is required, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent.
Danish: 4.3) Hvis sådanne behandlinger er påkrævet bør det det overvejes at anvende en anden type dialysemembran eller en anden type antihypertensivum.
English: A single oral dose of ramipril produced an undetectable level of ramipril and its metabolites in breast milk.
Danish: En enkelt oral dosering af ramipril gav et ikke-detekterbart niveau af ramipril, og dets metabolit i modermælk.
English: • If you have severe liver problems
Danish: • Hvis du lider af alvorlig leversygdom
English: You must tell your doctor if you think that you are (or might become) pregnant You should not take TRITAZIDE in the first 12 weeks of pregnancy, and you must not take them at all after the 13th week as their use during pregnancy may possibly be harmful to the baby.
Danish: Fortæl det altid til lægen hvis du tror du er gravid eller overvejer at blive det. Du bør ikke anvende Tritace i de første 12 uger af din graviditet, og efter den 13. uge bør du helt undgå at tage TRITAZIDE da medicinen kan være skadeligt for fosteret.
English: Athletes Hydrochlorothiazide may produce a positive analytic result in the anti-doping test.
Danish: Atleter Hydrochlorothiazider kan inducere et positivt resultat i antidoping test.
English: Steady-state plasma concentrations of ramiprilat after once daily dosing with the usual doses of ramipril are reached by about the fourth day of treatment.
Danish: Steady-state plasmakoncentration af ramiprilat efter en daglig dosering med sædvanlig dosis ramipril opnås omtrent på behandlingens fjerdedag.
English: TRITAZIDE should be started at the lowest available dosage.
Danish: TRITAZIDE skal initieres med lavest mulige dosis.
English: Antidiabetic agents including insulin: Hypoglycaemic reactions may occur.
Danish: Antidiabetika inklusiv insulin: Hypoglykæmiske reaktioner kan opstå.
English: As with other ACE inhibitors, ramipril may be less effective in lowering blood pressure in black people than in non black patients, possibly because of a higher prevalence of hypertension with low renin level in the black hypertensive population.
Danish: Som med andre ACE-hæmmere kan ramipril være mindre effektiv til sænkning af blodtrykket hos sorte patienter end hos ikke-sorte patienter, sandsynligvis på grund af en højere prævalens af hypertension med lavt renin niveau hos den sorte, hypertensive population.
English: • Difficulty breathing or worsening of asthma
Danish: Vejrtrækningsproblemer eller forværring af astma
English: 2970 Hørsholm Denmark
Danish: Slotsmarken 13 2970 Hørsholm Danmark
English: The CHMP included under this session the warning about Primary Hyperaldosteronism, therefore adopted the following harmonised wording: “The combination ramipril + hydrochlorothiazide does not represent a treatment of choice for primary hyperaldosteronism.
Danish: CHMP inkluderede i dette afsnit advarslen om primær hyperaldosteroisme og vedtog derfor den følgende harmoniserede formulering: "Kombinationen af ramipril og hydrochlorothiazid udgør ikke et behandlingstilbud mod primær hyperaldosteroisme.
English: Sanofi-aventis Belgium Culliganlaan 1C 1831 Diegem Belgium
Danish: Sanofi-aventis Belgien Culliganlaan 1C 1831 Diegem Belgien
English: • If you have kidney problems where the blood supply to your kidney is reduced(renal artery stenosis)
Danish: • Hvis du lider af nyresygdom hvor blodtilførslen til nyrerne er nedsat (renal arterie stenose)
English: It is recommended that treatment with angiotensin converting enzyme inhibitors such as ramipril should be discontinued where possible one day before surgery.
Danish: Det anbefales at behandling med angiotensin converting enzyme-hæmmere såsom ramipril seponeres, om muligt en dag før operationen.
English: • Patients at particular risk of hypotension
Danish: Patienter med særlig risiko for hypertension
English: The average response to ACE inhibitor monotherapy was lower in black (AfroCaribbean) hypertensive patients (usually a low-renin hypertensive population) than in non-black patients.
Danish: Det gennemsnitlige respons på ACE hæmmer monoterapi var lavere hos sorte (Afro-Caribbean) hypertensive patienter (sædvanligvis en lav-renin hypertensiv befolkning) end hos ikke-sorte patienter.
English: Thiazides during breast-feeding by lactating mothers have been associated with a decrease or even suppression of lactation.
Danish: Thiazider gennem modermælk er blevet forbundet med en nedgang eller endda udeblivelse af amning.
English: This could be a sign of pancreatitis (inflammation of the pancreas)
Danish: Dette kan være tegn på pancreatitis (betændelse i bugspytkirtlen).
English: As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Danish: Som ved al diuretika behandling, bør periodiske bestemmelser af serum elektrolytter foretages med passende intervaller.
English: • Steroid medicines for inflammation such as prednisolone
Danish: • Steroider mod betændelse såsom prednisolon
English: Patients with creatinine clearance levels between 30 and 60 ml/min should only be treated with the lowest fixed dose combination of ramipril and hydrochlorothiazide after administration of ramipril alone.
Danish: Patienter med kreatininclearence mellem 30 og 60 ml/min bør kun behandles med lavest dosiskombination af ramipril og hydrochlorothiazid efter administration af ramipril alene.
English: There were however some contraindications with HCTZ labelled in some local SPC's and not proposed in the harmonised SPC.
Danish: Der var dog visse kontraindikationer, hvor HCTZ fremgik af lokale produktresuméer og ikke fremgik af det harmoniserede produktresumé.
English: Possible mechanisms of the antihypertensive action of hydrochlorothiazide could be: the modified sodium balance, the reduction in extracellular water and plasma volume, a change in renal vascular resistance as well as a reduced response to norepinephrine and angiotensin II.
Danish: Hydrochlorthiazids mulige antihypertensive virkningsmekanismer kunne være: Ændret natriumbalance, reduktion af ekstracellulært vand og plasmavolumen, ændring i den renale vaskulære modstand såvel som et reduceret respons overfor noradrenalin og angiotensin II.
English: TRITAZIDE is contraindicated in severe renal impairment due to the hydrochlorothiazide component (creatinine clearance < 30 ml/min) (see section 4.3).
Danish: TRITAZIDE er kontraindiceret ved alvorlig nedsat nyrefunktion på grund af stoffet hydro-chlorothiazid (Kreatininclearence < 30 ml/min) (se afsnit 4.3).
English: • Medicines used for the treatment of low blood pressure, shock, cardiac failure, asthma or allergies such as ephedrine, noradrenaline or adrenaline.
Danish: • Medicin mod for lavt blodtryk, shock, hjertesvigt, astma eller allergi såsom efedrin, noradrenalin eller adrenalin.
English: Carbamazepine: risk of hyponatraemia due to additive effect with hydrochlorothiazide.
Danish: Carbamazepin: Risiko for hyponatriami pga. Af den additive effect med hydrochlorothiazide.
English: Considering that no major concern can be established concerning the safety, efficacy and clinical adverse event of the ramipril/HCTZ combination in non responders to HCTZ and ramipril alone, the CHMP adopted the following two harmonised wordings for indications: -Treatment of essential hypertension -This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled with ramipril alone or hydrochlorothiazide alone.
Danish: I betragtning af, at der ikke er nogen større problemer i forhold til sikkerhed, effekt og kliniske bivirkninger i forbindelse med kombinationen ramipril/HCTZ hos patienter, der ikke responderer på HCTZ og ramipril alene, vedtog CHMP følgende to harmoniserede formuleringer af indikationer: - Behandling af essentiel hypertension - Denne fastdosiskombination er indiceret til patienter, hvis blodtryk ikke kan kontrolleres tilfredsstillende ved hjælp af ramipril eller hydrochlorothiazid alene.
English: Bronchospasm including asthma aggravated
Danish: Bronkospasme inklusiv forværring af astma
English: Hyperkalaemia may occur; therefore close monitoring of serum potassium is required.
Danish: Hyperkaliæmi kan opstå, derfor kræves tæt monitorering af serumkalium.
English: Nonsteroidal anti-inflammatory drugs and acetylsalicylic acid: Reduction of the antihypertensive effect of TRITAZIDE is to be anticipated.
Danish: Nonsteroide antiinflammatoriske stoffer og acetylsalicylsyre: Reduktionen af den antihypertensive effekt af TRITAZIDE er forventelig.
English: Peak concentrations of ramiprilat in these patients, however, are not different from those seen in subjects with normal hepatic function.
Danish: Maksimal koncentrationerne af ramiprilat hos disse patienter er dog ikke forskellige fra dem set hos subjekter med normal leverfunktion.
English: Myocardial infarction
Danish: Myokardie infarkt
English: Hydrochlorothiazide can reduce plasma volume as well as the uteroplacental blood flow.
Danish: Hydrochlorthiazid kan reducere plasmavolumen såvel som den uteroplacentale blodcirkulation.
English: The CHMP recommended a contraindication only for the second and third trimester of pregnancy in line with PhVWP wording on use of AEC-I in pregnancy.
Danish: CHMP anbefalede kun en kontraindikation for graviditetens andet og tredje trimester i overensstemmelse med ordlyden fra arbejdsgruppen vedrørende lægemiddelovervågning i forbindelse med brug af ACE-I under graviditet.
English: Blood potassium increased due to ramipril
Danish: Blood kalium forhøjet pga ramipril
English: The CHMP also adopted a harmonised wording regarding pregnancy and lactation under this section (see SPC).
Danish: CHMP vedtog desuden en harmoniseret formulering om graviditet og amning under dette punkt (se produktresuméet).
English: • If you have high amounts of potassium in your blood (shown in blood test results)
Danish: • Har højt indhold af kalium i dit blod (set i blodprøveresultater)
English: Ramipril and hydrochlorothiazide are excreted in breast milk to such an extent that effects on the suckling child are likely if therapeutic doses of ramipril and hydrochlorothiazide are administered to breast-feeding women.
Danish: Ramipril og hydrochlorthiazid udskilles i modermælk i en sådan grad, at effekt på det ammende barn er sandsynliggjort, hvis der administreres terapeutiske doser af ramipril og hydrochlorthiazid til den ammende kvinde.
English: • If you have lost a lot of body salts or fluids (through being sick (vomiting), having diarrhoea, sweating more than usual, being on a low salt diet, taking diuretics (water tablets) for a long time or having had dialysis)
Danish: • Har mistet store mængder kropsvæske og salt (efter at have kastet op, haft diarre, har svedt mere end normalt, har været på diæt med lavt saltindhold, hvis du har taget vanddrivende medicin over længere tid, eller hvis du har været i dialysebehandling)
English: Cumulative effects of the active substance may develop in patients with impaired renal function.
Danish: Kumulativ effekt af det aktive indhodsstof kan opstå hos patienter med nedsat nyrefunktion.
English: Penicillin: hydrochlorothiazide is excreted in the distal tubulus, and reduces excretion of penicillin.
Danish: Penicillin: HydroChlorothiazid udskilles i distla tubulus og reducerer udskillelsen af penicillin.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Danish: ADVARSEL OM; AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: AstraZeneca S.p.A Palazzo Volta Via Francesco Sforza 20080 Basiglio (MI) Italy
Danish: Palazzo Volta Via Frankrigsco Sforza 20080 Basiglio (MI) Italien
English: Latent diabetes mellitus may become manifest during thiazide therapy.
Danish: Latent diabetes mellitus kan blive manifest under behandling med thiazider.
English: Pharmacodynamic effects
Danish: Farmakodynamiske effekter
English: Other side effects reported:
Danish: Andre rapporterede bivirkninger:
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Danish: Epidemiologiske tegn på risiko for teratogenicitet efter eksponering for ACE-hæmmere under graviditetens første trimester har ikke været entydige, men en mindre stigning i risikoen kan ikke udelukkes.
English: Your doctor will need to check your blood pressure.
Danish: Din læge vil tage dit blodtryk.
English: Iodine containing contrast media: in case of dehydration induced by diuretics including hydrochlorothiazide, there is increased risk of acute renal impairment, in particular when use of important doses of iodine containing contrast media.
Danish: Kontrast media indeholdende iod: I tilfælde af dehydrering induceret af diuretika inklusive hydrochlorothiazid, er der en forøget risiko for akut nuresvigt, specielt ved anvendelse af store mængder kontrast media indeholdende iod.
English: Malta Netherlands
Danish: Malta Holland
English: Non-productive tickling cough, bronchitis
Danish: Nonproduktiv kildende hoste, bronkitis
English: TRITAZIDE has to be swallowed with liquid.
Danish: TRITAZIDE skal synkes med væske.
English: SANOFI-AVENTIS GMBH OSTERREICH SATURN Tower Leonard-Bernstein-Straße 10 A-1220 Vienna Austria
Danish: SANOFI-AVENTIS GMBH OSTERREICH SATURN Tower Leonard-Bernstein-Straße 10 A-1220 Vienna Østrig
English: Patients with strongly activated renin-angiotensin-aldosterone system are at risk of an acute pronounced fall in blood pressure and deterioration of renal function due to ACE inhibition, especially when an ACE inhibitor or a concomitant diuretic is given for the first time or at first dose increase.
Danish: Patienter med stærkt aktiveret renin-angiotensin-aldosteronsystem har risiko for udtalt blodtryksfald, og forværrelse af nyrefunktionen grundet ACE-hæmning, særligt når en ACE-hæmmer eller samtidigt diuretikum gives første gange, eller ved første dosisøgning.
English: • Loss or change in the way things taste
Danish: Mistet eller ændring i smagssans
English: This is because TRITAZIDE can affect the way some other medicines work.
Danish: Dette er fordi TRITAZIDE kan påvirke den måde anden medicin virker på ligesom anden medicin kan påvirke den måde TRITAZIDE virker på.
English: Dilutional hyponatraemia may occur.
Danish: Dilutional hyponatræmi kan forekomme.
English: Please tell your doctor if any of the following gets serious or lasts longer than a few days.
Danish: Kontakt lægen hvis nogen af følgende bivirkninger bliver alvorlige eller hvis de varer længere end et par dage:
English: After multiple once-daily doses of ramipril, the effective half-life of ramiprilat concentrations was 1317 hours for the 5-10 mg doses and longer for the lower 1.25-2.5 mg doses.
Danish: Efter flere doser ramipril en gang daglig er den effektive halveringstid af ramiprilatkoncentrationerne 1317 timer for 5-10 mg doser, og endnu længere for 1,25-2,5 mg doser.
English: Pharmacokinetics and Metabolism
Danish: Farmakokinetik og Metabolisme
English: Reduced angiotensin II formation and inhibition of bradykinin breakdown lead to vasodilatation.
Danish: Nedsat angiotensin II dannelse og hæmning af bradykinins nedbrydning fører til vasodilatation.
English: Excretion of the metabolites is primarily renal.
Danish: Udskillelse af metabolitterne foregår primært renalt.
English: The combination 2.5mg /12.5mg led to greater reduction in blood pressure than the treatment with individual components, and the combination of 5mg/25mg produced a better therapeutic effect than doubling the ramipril dose to 10mg.
Danish: Kombinationen 2,5 mg/12,5 mg medførte større fald i blodtrykket end behandling med enkeltkomponenter, og kombinationen af 5 mg/25 mg havde en bedre terapeutisk effekt, end når dosis af ramipril blev fordoblet til 10 mg.
English: SANOFI-AVENTIS BULGARIA EOOD Alexandar Stamboliyski blvd. 103 office building Sofia Tower, fl. 8, Sofia 1303
Danish: Alexandar Stamboliyski blvd. 103 office building Sofia Tower, fl. 8, Sofia 1303
English: Hydrochlorothiazide stimulates renal calcium reabsorption and may cause hypercalcaemia.
Danish: Hydrochlorothiazid stimulerer calcium reabsorptionen og kan forårsage hypercalkæmi.
English: Slovak Republic SANOFI-AVENTIS SLOVAKIA s.r.o., Žilinská 7-9
Danish: SANOFI-AVENTIS SLOVAKIA s.r.o., Žilinská 7-9
English: TRITAZIDE is a combination of two medicines called ramipril and hydrochlorothiazide.
Danish: TRITAZIDE er en kombination af to slags lægemidler der kaldes ramipril og hydroklorthiazid.
English: The blood-pressure-lowering effect is accompanied by slight increases in the filtration fraction, renal vascular resistance and plasma renin activity.
Danish: Den blodtrykssænkende effekt ledsages af en let øgning af filtrationsfraktionen, den renale vaskulære modstand og plasmareninaktivitet.
English: They can increase the chance of getting side effects if you take them with TRITAZIDE:
Danish: Risikoen for bivirkninger kan øges, hvis de tages sammen med TRITAZIDE:
English: The concurrent administration of ramipril and hydrochlorothiazide does not affect their bioavailability.
Danish: Samtidig administration af ramipril og hydrochlorthiazid påvirker ikke biotilgængeligheden.
English: TRITAZIDE may increase the amount of lithium in your blood.
Danish: Tritace kan øge indholdet af litium i blodet.
English: • Red swollen tongue or dry mouth
Danish: Rød hævet tunge eller mundtørhed
English: More frequent monitoring is advised in the initial phase of treatment and in patients with impaired renal function, those with concomitant collagen disease (e.g. lupus erythematosus or scleroderma), and all those treated with other medicinal products that can cause changes in the blood picture (see sections 4.5 and 4.8).
Danish: Mere hyppig monitorering tilrådes i den initielle fast af behandlingen, og hos patienter med nedsat nyrefunktion, samtidig kollagen sygdom (f.eks. lupus erythematosus eller skleroderma), og for alle i behandling med andre lægemidler, der kan medføre ændringer i blodbilledet.
English: The combination of ramipril and hydrochlorothiazide with lithium is therefore not recommended.
Danish: Kombinationen med ramipril og hydrochlorothiazide med litium anbefales derfor ikke.
English: These can be signs of blood or bone marrow problems.
Danish: Dette kan være tegn på blod- eller knoglemarvs problemer.
English: Moreover, rare cases of hypoglycaemia and thrombocytopenia in neonates have been reported in case of exposure near term.
Danish: Der udover er der rapporteret om sjældne tilfælde af hypoglykæmi og trombocytopeni i nyfødte ved eksponering tæt på termin.
English: ANNEX IISCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL FREMLAGT AF EMEA
English: • Allopurinol (used to lower the uric acid in your blood)
Danish: • Allupurinol (anvendes til at mindske mængden af urinsyre i blodet)
English: • If you have abnormal amounts of salt substances (calcium, potassium, sodium) in your blood
Danish: • Hvis du har unormale saltværdier (kalcium, kalium, natrium) i blodet
English: Plasma concentrations of ramiprilat decline in a polyphasic manner.
Danish: Plasmakoncentrationerne af ramiprilat falder polyfasisk.
English: Suggested measures include primary detoxification (gastric lavage, administration of adsorbents) and measures to restore haemodynamic stability, including administration of alpha 1 adrenergic agonists or angiotensin II (angiotensinamide) administration.
Danish: Der foreslås primær detoksifikation (ved f.eks. maveskylning, administration af adsorbanter) og foranstaltninger til at genskabe hæmodynamisk stabilitet, såsom administration af alpha 1 adrenerge agonister eller angiotensin II (angiotensinamid).
English: Angioedema: very exceptionally, the airway obstruction resulting from angioedema may have a fatal outcome; dermatitis psoriasiform, hyperhidrosis, rash, in particular maculo-papular, pruritus, alopecia
Danish: Angioedema: I meget sjældne tilfælde kan luftvejsobstruktionen forårsaget af angioødem have dødelig udgang; dermatitis psoriasiform, hyperhidrosis, rødme,især makulopapular, pruritus, alopeci
English: Presumably through blockade of the renin-angiotensin-aldosterone system, co-administration of ramipril to hydrochlorothiazide tends to reverse the potassium loss associated with these diuretics.
Danish: Formentlig via en blokade af renin-angiotension-aldosteronsystemet har co-administration af ramipril med hydrochlorthiazid en tilbøjelighed til at kunne reversere kaliumtabet der normalt ses med disse diuretika.
English: The CHMP pointed out that this indication is limited to essential hypertension and the positioning of the indications is add-on therapy when each monotherapy has failed.
Danish: CHMP påpegede, at denne indikation kun omfatter essentiel hypertension, og indikationerne udgør tillægsbehandling efter mislykket monoterapi.
English: Please tell your doctor if you are taking any of the following medicines.
Danish: Tal med din læge, hvis du anvender følgende typer medicin.
English: The pharmacokinetics of hydrochlorothiazide has not been studied in patients with cardiac failure.
Danish: Farmakokinetikken for hydrochlorthiazid er ikke blevet undersøgt hos patienter med hjerteinsufficiens.
English: In case of angioedema TRITAZIDE must be discontinued.
Danish: I tilfælde af angioødem skal TRITAZID seponeres.
English: • Dehydration
Danish: Dehydrering
English: Colestyramine or other enterally administered ion exchangers: reduced absorption of hydrochlorothiazide.
Danish: Cholestyramin og andre entero administreret ionbyttere: nedsat absorption af hydrochlorthiazid.