FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the effect of multiple doses is not known.
Danish: Dog kendes ikke effekten af flere doser.
English: 1000 Ljubljana Slovenia
Danish: 1000 Ljubljana Slovenien
English: The list of products which interact or may interact with Tritazide is acceptable.
Danish: Listen over produkter, som interagerer eller kan interagere med Tritazide, er acceptabel.
English: Ethnic differences
Danish: Etniske forskelle
English: Lithium levels must be monitored.
Danish: Lithiumniveauet skal monitoreres.
English: It must not be chewed or crushed.
Danish: Må ikke tygges eller knuses.
English: The patient should be closely monitored and the treatment should be symptomatic and supportive.
Danish: Patienten bør monitoreres tæt, og behandles symptomatisk og understøttende.
English: How much to take
Danish: Hvor meget der skal tages:
English: The CHMP adopted the proposed interactions under this section.
Danish: CMPH vedtog de foreslåede interaktioner under dette punkt.
English: • TRITAZIDE may be taken with or without food.
Danish: • Du kan anvende TRITAZIDE sammen med, eller uden mad.
English: • Reduced sexual desire in men or women
Danish: Nedsat seksuel lyst hos mænd og kvinder
English: If you have diabetes, this may make your diabetes worse
Danish: Hvis du har diabetes, kan det forværre din diabetes.
English: 4.5 Interaction
Danish: 4.5 Interaktion
English: This could be a sign of a severe allergic reaction to TRITAZIDE
Danish: Dette kan være tegn på en alvorlig allergisk reaktion mod TRITAZIDE
English: Do not take TRITAZIDE if any of the above apply to you.
Danish: Anvend ikke TRITAZIDE hvis noget af det ovenstående gælder for dig.
English: Critical Evaluation
Danish: Kritisk vurdering
English: Testing should be more frequent in elderly and cirrhotic patients.
Danish: Måling bør foretages oftere hos ældre og cirrhotiske patienter.
English: The combination product can be considered as bioequivalent to products containing the individual components.
Danish: Kombinationen betragtes som bioækvivalent med produkter der indeholder de individuelle komponenter.
English: The main areas for harmonisation were as follows:
Danish: Følgende hovedområder skulle harmoniseres:
English: Do not drive to the hospital, get somebody else to take you or call for an ambulance.
Danish: Du må ikke selv køre bil, få derfor en anden til at køre dig, eller ring efter en ambulance.
English: Worsening of a preexisting proteinuria
Danish: Forværring af præeksisternde proteinuria
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF TRITAZIDE AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF TRITAZIDE OG TILKNYTTEDE NAVNE (SE BILAG I)
English: In most cases the initial dose is the same, but there are differences with respect to subsequent titration (both in terms of frequency of increase and maximum daily dose).
Danish: I de fleste tilfælde er initialdosis ens, men der er forskelle i forbindelse med den efterfølgende titrering (både i forhold til hyppigheden af øgning og maksimal daglig dosis).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Danish: ANVENDELSESOMRÅDE OG ADMINISTRATIONSVEJ(E) Oral anvendelse.
English: Adverse reactions frequency is defined using the following convention: 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), not known (cannot be estimated from the available data).
Danish: Hyppigheden af bivirkningerne er defineret ud fra følgende konvention: 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: This may be a sign of your body holding onto more water than usual
Danish: Hvilket kan være et tegn på at kroppen tilbageholder mere vand end vanligt.
English: Sulphonamide diuretics should be taken at least one hour before or four to six hours after these medications.
Danish: Sulfonamid diuretika bør tages mindst en time før eller fire til seks timer efter disse lægemidler.
English: The two active substances work together to lower your blood pressure.
Danish: De to aktive lægemidler virker sammen for at nedsætte blodtrykket.
English: 176-74 Kallithea Greece
Danish: 176-74 Kallithea Grækenland
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Danish: Dette lægemiddeler godkendt i EEAs medlemslande under følgende navne: Østrig:
English: Patient should be kept under observation for at least 12 to 24 hours and discharged after complete resolution of the symptoms.
Danish: Patienten bør holdes under observation i mindst 12 til 24 timer, og udskrives efter fuldstændig opløsning af symptomerne.
English: It may harm them even if their symptoms are the same as yours.
Danish: Det kan være skadeligt for andre, selvom de har de samme symptomer som du har.
English: Methyldopa: Haemolysis possible.
Danish: Methyldopa: Hæmolyse er muligt.
English: Stop taking TRITAZIDE and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:
Danish: Stop indtagelse af TRITAZIDE ogkontaktr lægen med det samme, hvis du oplever én af følgende alvorlige bivirkninger - du kan have brug for akut lægehjælp:
English: The elimination half-life is 5 to 6 hours.
Danish: Eliminationshalveringstiden er 5-6 timer.
English: Like all medicines, TRITAZIDE can cause side effects, although not everybody gets them.
Danish: TRITAZIDE kan som al anden medicin give bivirkninger, selvom ikke alle får bivirkninger.
English: 167 14 Bromma Sweden
Danish: 167 14 Bromma Sverige
English: Box 2043
Danish: P.O. Box 2043
English: Emergency therapy should be instituted promptly.
Danish: Nødbehandling bør iværksættes hurtigt.
English: However the company challenged this view and proposed a contraindication through out pregnancy, based on data from the ramipril pregnancy register.
Danish: Virksomheden rejste imidlertid tvivl om dette synspunkt og foreslog en kontraindikation under hele graviditeten baseret på data fra graviditetsregistret for ramipril.
English: Arthralgia, muscle spasms
Danish: Arthralgia, muskel spasms
English: It is recommended to monitor the white blood cell count to permit detection of a possible leucopoenia.
Danish: Det anbefales, at monitorere det hvide blodlegemetal for at kunne detektere muligt leukopeni.
English: You may need to stop your TRITAZIDE treatment one day beforehand; ask your doctor for advice
Danish: Det kan være nødvendigt at stoppe Tritace behandlingen en dag i forvejen; spørg din læge
English: • Making your blood vessels relax and widen
Danish: • Får dine blodkar til at slappe af og udvide sig
English: If you become pregnant while on TRITAZIDE, tell your doctor immediately.
Danish: Hvis du bliver gravid mens du er i behandling med TRITAZIDE, skal du fortælle det til din læge med det samme.
English: It works by:
Danish: Det virker ved at:
English: They are used together when treatment with just one did not work.
Danish: De anvendes sammen hvor behandling med den ene slags medicin ikke har været nok.
English: Reproduction studies in rats and rabbits revealed that the combination is somewhat more toxic than either of the single components but none of the studies revealed a teratogenic effect of the combination.
Danish: Reproduktionsstudier i rotter og kaniner viste, at kombinationen er en anelse mere toksisk end hver af de enkelte komponenter, men ingen af studierne viste teratogene effekter af kombinationen.
English: Contra-indicated combinations
Danish: Kontraindicerede kombinationer
English: • Medicines to stop the rejection of organs after a transplant such as ciclosporin
Danish: • Medicin der stopper afstødning af organer efter en transplantation såsom ciklosporin
English: Anorexia, decreased appetite
Danish: Anoreksi, nedsat appetit
English: They are extended with the contraindications of HCTZ.
Danish: De er udvidet til også at omfatte kontraindikationerne for HCTZ.
English: The increased renal excretion of these ions is accompanied by increased urine output (due to osmotic binding of water).
Danish: Den øgede renale udskillelse af disse ioner ledsages af øget urinudskillelse (på grund af osmotisk binding af vand).
English: TRITAZIDE and associated names should be started at the lowest available dosage.
Danish: TRITAZIDE og tilknyttede navne bør påbegyndes ved den mindst mulige dosis.
English: Zentiva HU Kft Népfürdo u.22 1138 Budapest Hungary
Danish: Zentiva HU Kft Népfürdo u.22 1138 Budapest Ungarn
English: Based on urinary recovery, the extent of absorption is at least 56 % and is not significantly influenced by the presence of food in the gastrointestinal tract.
Danish: Absorptionen er, baseret på urinopsamling, mindst 56 % og er ikke betydeligt influeret af tilstedeværelsen af mad i mave-tarmkanalen.
English: • Decreasing your body's production of substances that raise your blood pressure
Danish: • Mindske kroppens produktion af stoffer der gør, at man får forhøjet blodtryk
English: • If you have ever had a serious allergic reaction called “angioedema”.
Danish: • Hvis du tidligere har haft en alvorlig overfølsomhedsreaktion der kaldes ”angioødem”.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I LISTE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, ADMINISTRATIONSVEJE, INDEHAVER AF MARKEDSFØRINGSTILLADELSEN I MEDLEMSLANDENE
English: If low potassium levels are detected, correction is required.
Danish: Hvis lavt kaliumnivau måles, er korrektioner nødvendige.
English: If this happens, do not drive or use any tools or machines.
Danish: Hvis dette sker for dig, bør du ikke køre eller bruge visse former for maskiner.
English: This may be given for an operation or any dental work.
Danish: Dette kan være i forbindelse med en operation eller tandlægebesøg.
English: • Quinine (for malaria)
Danish: • Quinine (mod malaria)
English: Repeated doses administration studies performed in rats and monkeys revealed only disturbances in electrolytes balance.
Danish: Studier med gentagne administrationer i rotter og aber har kun vist forstyrrelser i elektrolytbalancen.
English: • If you are sports person having an anti-doping test. TRITAZIDE might give you a positive result.
Danish: • Hvis du skal have foretaget en anti-doping test. TRITAZIDE kan give positivt resultat.
English: Taking TRITAZIDE with food and alcohol
Danish: Brug af TRITAZIDE sammen med mad og drikke
English: • If you are having dialysis or any other type of blood filtration.
Danish: • Hvis du er i dialysebehandling eller andre typer filtrering af blodet.
English: Monitoring of renal function
Danish: Monitorering af nyrefunktionen
English: It has been shown that the antihypertensive effect is sustained under long term therapy lasting 2 years.
Danish: Det har vist sig, at den antihypertensive effekt opretholdes under langtidsterapi på to år.
English: The majority of the contraindications are related to use of ramipril as a component of the Tritazide.
Danish: Størstedelen af kontraindikationerne vedrører brugen af ramipril som komponent i Tritazide.
English: Tritazide was included in the list of products for Summary of Products Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended, as the abovementioned medicinal product does not have the same SPC across EU Member States, Iceland and Norway.
Danish: Tritazide stod på den liste over produkter, for hvilke produktresuméerne skulle harmoniseres, som CMD(h) havde udarbejdet i henhold til artikel 30, stk. 2, i direktiv 2001/83/EF, med senere ændringer, da produktresuméet for ovennævnte lægemiddel ikke er det samme i de forskellige medlemsstater, Island og Norge.
English: - Patients with strongly activated renin-angiotensin-aldosterone system
Danish: - Patienter med stærkt aktiveret renin-angiotensin-aldosteronsystem.
English: No studies on mutagenicity and carcinogenicity have been performed with the combination as studies with individual components showed no risk.
Danish: Der er ikke udført studier for mutagenicitet og carcinogenicitet for kombinationen, da studier med de individuelle stoffer ingen risiko har vist.
English: POLIFARMA SPA Viale dell'Arte 69 00144 Roma Italy
Danish: Viale dell'Arte 69 00144 Roma Italien
English: Peak plasma concentrations of hydrochlorothiazide are reached within 1.5 to 5 hours.
Danish: Maksimal plasmakoncentration af hydrochlorthiazid opnås inden for 1,5 til 5 timer.
English: After the first dose or subsequent increases in dose it is not advisable to drive or operate machinery for several hours.
Danish: Efter første dosis eller efterfølgende stigninger i dosis frarådes det, at føre motorkøretøjer, eller betjene maskiner i adskillige timer).
English: 56218 Mülheim-Kärlich Germany
Danish: 56218 Mülheim-Kärlich Tyskland
English: NL-2800 BD Gouda The Netherlands
Danish: NL-2800 BD Gouda Holland
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg din læge eller apoteket til råds, før du tager nogen form for medicin
English: Reduction in sodium levels can be initially asymptomatic and regular testing is therefore essential.
Danish: Reduktion i natrium niveau kan initialt være asymptomatisk og jævlig måling er derfor nødvendig.
English: Administration of ramipril causes a marked reduction in peripheral arterial resistance.
Danish: Administration af ramipril forårsager en udtalt reduktion i den periferalee arterielle modstand.
English: The maximum antihypertensive effect of continued treatment with ramipril is generally apparent after 3 to 4 weeks.
Danish: Den maksimale antihypertensive effekt af fortsat behandling med ramipril ses almindeligvis efter 3 til 4 uger.
English: Initial doses should be lower and subsequent dose titration should be more gradual because of greater chance of undesirable effects especially in very old and frail patients.
Danish: Startdosis bør være lavere og efterfølgende dosistitrering bør se ske mere gradvist, grundet større risiko for bivirkninger, særligt hos meget gamle og skrøbelige patienter.
English: Always take TRITAZIDE exactly as your doctor has told you.
Danish: Tag altid TRITAZIDE nøjagtigt efter lægens anvisning.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier
English: Because of the potential for serious reactions in nursing infants from both active substances, a decision should be made whether to discontinue nursing or to discontinue therapy taking account of the importance of this therapy to the mother.
Danish: Grundet risikoen for alvorlige reaktioner overfor de to aktive stoffer hos ammende nyfødte, bør der der tages en beslutning om hvorvidt amning eller behandling bør ophøre, med hensyntagen til vigtigheden af denne behandling for moderen.
English: Consideration must be given to reducing the diuretic dose or discontinuing the diuretic before starting treatment with TRITAZIDE.
Danish: Det bør overvejes at reducere dosis af diuretika eller stoppe behandling med diuretika før behandling med TRITAZIDE startes.
English: Anaphylactic reactions during desensitization
Danish: Anafylaktiske reaktioner under desensibilisering
English: • Primary Hyperaldosteronism
Danish: - Primær hyperaldosteronisme
English: Generally, it is recommended to correct dehydration, hypovolaemia or salt depletion before initiating treatment (in patients with heart failure, however, such corrective action must be carefully weighed out against the risk of volume overload).
Danish: Generelt anbefales det, at udbedre dehydrering, hypovolæmi eller saltmangel før behandlingen påbegyndes (dog bør sådanne korrigerende handlinger nøje vurderes mod risikoen for volumenoverbelastning hos patienter med hjerteinsufficiens).
English: Elderly Your doctor will reduce the initial dose and adjust your treatment more slowly.
Danish: Ældre: Lægen vil nedsætte startdosis og tilpasse behandlingen langsomt.
English: SANOFI-AVENTIS ESTONIA OÜ Pärnu mnt. 139 E/2 11317 Tallinn Estonia
Danish: SANOFI-AVENTIS ESTONIA OÜ Pärnu mnt. 139 E/2 11317 Tallinn Tyskland
English: The antihypertensive effect of a single dose usually lasts for 24 hours.
Danish: Den antihypertensive virkning af en enkelt dosis varer sædvanligvis 24 timer.
English: • Medicines for cancer (chemotherapy)
Danish: • Medicin mod kræft (kemoterapi)
English: • Swollen arms and legs.
Danish: Hævede arme og ben.
English: These patients presented with abdominal pain (with or without nausea or vomiting).
Danish: Disse patienter meddelte om mavesmerter (med eller uden kvalme og opkastning).
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Danish: Hvis du har yderligere spørgsmål om anvendelsen af dette produkt kan du spørge på apoteket eller hos lægen.
English: The mechanism of antihypertensive effect of thiazide diuretics is not fully known.
Danish: Mekanismen bag den antihypertensive effekt af thiazid er ikke fuldstændigt beskrevet.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Danish: MÆRKNING DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OUTER CARTON
English: A temporary discontinuation of TRITAZIDE should be considered prior to desensitization.
Danish: En midlertidig seponering af TRITAZIDE bør overvejes før desensibilisering.
English: SANOFI-AVENTIS CYPRUS LTD 14, Charalambou Mouskou street 2015 - Nicosia
Danish: SANOFI-AVENTIS CYPERN LTD 14, Charalambou Mouskou street 2015 - Nicosia
English: This can happen especially at the start of treatment, or when changing over from other preparations.
Danish: Dette forekommer især ved starten af behandlingen, ved overgang fra andre lægemidler.
English: Iceland Ireland sanofi-aventis Ireland Ltd. Citywest Business Campus Dublin 24
Danish: Island Irland sanofi-aventis Ireland Ltd. Citywest Business Campus Dublin 24
English: • Objects looking yellow
Danish: Fornemmelse af at ting ser gule ud
English: Because of its potent, saturable binding to ACE and slow dissociation from the enzyme, ramiprilat shows a prolonged terminal elimination phase at very low plasma concentrations.
Danish: Grundet den potente mættelige binding til ACE og langsomme adskillelse fra enzymet, viser ramiprilat en forlænget terminal eliminationsfase ved meget lave plasmakoncentrationer.
English: Treatment should be immediately discontinued in case of hepatic encephalopathy.
Danish: Behandlingen skal straks stoppes i tilfælde af hepatisk encefalopati.
English: Lithuania Luxembourg
Danish: Letland Lithauen Luxembourg
English: Distribution The serum protein binding of ramipril is about 73 % and that of ramiprilat about 56 %.
Danish: Distribution Serum proteinbindingen af ramipril er omkring 73 % og omkring 56 % for ramiprilat.
English: Patients with impairment of renal function may require reduced doses of TRITAZIDE.
Danish: Patienter med nedsat nyrefunktion kan behøve dosisreduktion af TRITAZIDE.
English: The first measurement of plasma potassium levels should be carried out during the first week following the start of treatment.
Danish: Den første bestemmelse af plasmakalium bør udføres under den første uges behandling.
English: Your lithium amount will need to be closely checked by your doctor
Danish: Dit litiumindhold skal derfor overvåges nøje af din læge.
English: - Patients at risk of cardiac or cerebral ischemia in case of acute hypotension The initial phase of treatment requires special medical supervision.
Danish: -Patienter med risiko for kardiel- eller cerebral iskæmi i tilfælde af akut hypotension Opstartsfasen af behandlingen kræver særligt medicinsk opsyn.
English: It inhibits the reabsorption of sodium and chloride in the distal tubule.
Danish: Det hæmmer reabsorptionen af natrium og chlorid i de distale tubuli.
English: • Severe stomach pain which may reach through to your back.
Danish: Alvorlig mavepine der strækker sig om til ryggen.
English: Pregnancy: ACE inhibitors such as ramipril, or Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Danish: Graviditet: ACE-hæmmere såsom ramipril eller Angiotension II Receptor Antagonister (AIIRA) bør ikke påbegyndes under graviditet.
English: • If you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus
Danish: • Har kollagen vaskulær sygdom såsom skleroderma eller systemisk lupus erythematosus
English: Treatment of high blood pressure Your doctor will adjust the amount you take until your blood pressure is controlled.
Danish: For højt blodtryk: Din læge vil justere din dosis indtil dit blodtryk er under kontrol.
English: • Calcium supplements
Danish: • Kalcium tilskud
English: This difference is related to the saturable capacity of the enzyme to bind ramiprilat.
Danish: Denne forskel relateres til den mættelige kapacitet af enzymets binding til ramiprilat.
English: The bioavailability of the active metabolite ramiprilat after oral administration of 2.5 mg and 5 mg ramipril is 45 %.
Danish: Biotilgængeligheden af den aktive metabolit ramiprilat efter oral administration af 2,5 mg og 5 mg ramipril er 45 %.
English: A number of areas of disharmony in the product information for Tritazide have been evaluated by the CHMP and a revised PI was adopted.
Danish: CHMP har vurderet en række områder, hvor der fandtes uoverensstemmelser i produktinformationen for Tritazide, og en revideret produktinformation blev vedtaget.
English: Curare-type muscle relaxants: Possible intensification and prolongation of the muscular relaxing effect.
Danish: Muskelafslappende midler af Curaretypen: Mulig forøgelse og forlængelse af den muskelafslappende effekt.
English: Do not pass it on to others.
Danish: Lad derfor være med at give Tritazide til andre.
English: AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel Germany
Danish: AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel
English: If any of the above apply to you (or you are not sure), talk to your doctor before taking TRITAZIDE.
Danish: Hvis noget af det ovenstående gælder for dig så (eller du er usikker), så kontakt din læge før du anvender TRITAZIDE.
English: If you are concerned about how much you can drink while you are taking TRITAZIDE, discuss this with your doctor as medicines used to reduce blood pressure and alcohol can have additive effects.
Danish: Hvis du er bekymret for hvor meget du må drikke samtidig med at du er i behandling med Tritace, bør du tale med din læge, da blodtrykssænkende medicin kan forstærke virkningen af alkohol.
English: SANOFI-AVENTIS France 1-13, boulevard Romain Rolland 75014 Paris
Danish: SANOFI-AVENTIS Frankrig 1-13, boulevard Romain Rolland 75014 Paris
English: Check your blood sugar amounts closely while taking TRITAZIDE
Danish: Kontroller derfor dit blodsukker nøje når du anvender Tritace.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLERELLER AFFALD FRA SÅDANNE
English: QUALITATIVE AND QUANTITATIVE COMPOSITION [To be completed nationally]
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING [Udfyldes nationalt]
English: Characteristically, the cough is nonproductive, persistent and resolves after discontinuation of therapy.
Danish: Det er karakteristisk for hosten, at den er nonproduktiv, vedvarende og ophører ved seponering af behandlingen.
English: The onset of the antihypertensive effect occurs after 3 to 4 days and can last up to one week after discontinuation of therapy.
Danish: Den antihypertensive effekt optræder efter 3-4 dage og varer i op til 1 uge efter behandlingsophør.
English: TRITAZIDE might affect the results of the test
Danish: TRITAZIDE kan påvirke testresultatet.
English: Renal function should be assessed before and during treatment and dosage adjusted especially in the initial weeks of treatment.
Danish: Nyrefunktionen bør fastslås før og under behandlingen, og dosis bør justeres i de første uger af behandlingen.