FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are not sure, talk to your doctor before taking TRITAZIDE.
Danish: Kontakt din læge før du anvender TRITAZIDE hvis du er usikker.
English: In patients concurrently treated with diuretics, as hypotension may occur following initiation of the treatment, caution is recommended.
Danish: Da hypotension kan forekomme efter start af behandlingen, anbefales forsigtighed hos patienter der samtidigt behandles med diuretika.
English: • Sleep problems
Danish: Søvnproblemer
English: Ramipril and Hydrochlorothiazide
Danish: Ramipril og hydrochlorthiazid
English: They may be affected by TRITAZIDE:
Danish: TRITAZIDE kan nemlig påvirke virkningen af dem:
English: -Hypersensitivity to the active substance or to any other ACE (Angiotensin Converting Enzyme) inhibitor, hydrochlorothiazide, other thiazide diuretics, sulphonamides or any of the excipients of TRITAZIDE and associated names (see section 6.1).
Danish: CMPH vedtog den harmoniserede formulering af kontraindikationerne: - Overfølsomhed over for det aktive stof eller over for andre angiotensinkonverterende enzymhæmmere (ACE-I), hydrochlorothiazid, andre thiazid-diuretika, sulfonamider eller et eller flere af hjælpestofferne i TRITAZIDE og tilknyttede navne (se pkt.
English: Hypersensitivity to sulphonamide-derived active substances, hypokalaemia and nuclear icterus might occur.
Danish: Der kan opstå hypokaliæmi og nuklear icteus ved overfølsomhed overofr sulfonamidderivater.
English: • Blood tests showing less potassium than usual in your blood.
Danish: Blodprøveresultater der viser mindre kalium i blodet end normalt
English: Insufficient information is available regarding the use of ramipril during breast-feeding and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Danish: 5.2), og der anbefales derfor alternativ behandling med bedre etableret sikkerhedsprofil under amning, særligt ved amning af nyfødte eller for tidligt fødte børn.
English: Administration of ramipril to patients with hypertension leads to a reduction in supine and standing blood pressure without a compensatory rise in heart rate.
Danish: Almindeligvis er der ingen større ændring i det renale plasma flow og den glomerulære filtrationsrate.Administration af ramipril til patienter med hypertension medfører en nedsættelse i det liggende og stående blodtryk uden en kompenserende stigning i hjertefrekvens.
English: Sialoadenitis due to hydrochlorothiazide
Danish: Sialoadenitis pga hydroklorothiazide
English: Sweden: Triatec Comp Mite 2.5 mg/12.5 mg tabletter, Triatec Comp 5 mg/25 mg tabletter
Danish: Sverige: Triatec Comp Mite 2.5 mg/12.5 mg tabletter, Triatec Comp 5 mg/25 mg tabletter
English: The ramipril active substance may induce persistent dry cough, while the hydrochlorothiazide active substance may lead to worsening of glucose, lipid and uric acid metabolism.
Danish: Sikkerhedsprofilen for ramipril + hydrochlorothiazide inkluder bivirkninger der skyldes hypotension og/eller væskemangel efter øget diuresis.. Ramipril inducerer persistevedvarende tør hoste , mens hydrochlorothiazide kan give anledning til forværret glucose, lipid og urinsyre metabolismen.De to aktive stoffer har invers effekt på plasma kalium..
English: Calculous cholecystitis due to hydrochlorothiazide
Danish: Calculous kolecystitis forårsaget af hydrochlorothiazide
English: The combination is indicated for the treatment of hypertension in all Member States where licensed, although it is noted that terms including essential hypertension, arterial hypertension and arterial essential hypertension are used.
Danish: Termer som essentiel hypertension, arteriel hypertension og arteriel essentiel hypertension bruges dog også.
English: Interstitial nephritis due to hydrochlorothiazide
Danish: Interstitial nephritis pga hydroklorothiazide
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription (including herbal medicines).
Danish: Fortæl det altid til lægen eller apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: Gingivitis due to hydrochlorothiazide
Danish: Gingivitis due pga hydroklorthiazid
English: This change of the text is to ensure it doesn't suggest an immediate artificial abortion, which is not justified by the clinical experiences collected till now.
Danish: Denne ændring af teksten skal sikre, at der ikke tilrådes til omgående provokeret abort, hvilket der ikke er grundlag for på baggrund af de kliniske erfaringer, der er indsamlet indtil nu. CHMP vedtog således en harmoniseret formulering i overensstemmelse med arbejdsgruppen vedrørende lægemiddelovervågnings formulering omkring brugen af ACE-I under graviditet.
English: Bulgaria: Tritace 2.5 Plus 2.5 mg/12.5 mg таблетки, Tritace 5 Plus 5 mg/25 mg таблетки
Danish: Bulgarien Tritace 2.5 Plus 2.5 mg/12.5 mg таблетки, Tritace 5 Plus 5 mg/25 mg таблетки
English: TRITAZIDE 2.5 5 mg/ 12,5 mg tablete
Danish: TRITAZIDE 2.5 5 mg/ 12,5 mg Tablettere
English: This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled with ramipril alone or hydrochlorothiazide alone.
Danish: Dette kombinationspræperat er indiceret til patienter, der ikke kan behandles sufficient med monoterapi.
English: Psychiatric disorders
Danish: Psykiske lidelser
English: These could be signs of lung problems including inflammation
Danish: Dette kunne være tegn på lungeproblemer.
English: The text agreed in the PhVWP of this warning doesn't encourage or propose the use of ACE inhibitors during the first trimester of the pregnancy on the contrary once the pregnancy is detected the prescriber has to stop the use of ACE inhibitors and to change if it is necessary for another antihypertensive agent as soon as possible.
Danish: Den tekst, som er vedtaget i arbejdsgruppen vedrørende lægemiddelovervågning for denne advarsel, opmuntrer ikke til eller foreslår at anvende ACE-hæmmere under graviditetens første trimester.
English: Spain Sweden sanofi-aventis AB
Danish: Spanien Sverige sanofi-aventis AB Box 14142
English: LIST OF EXCIPIENTS [To be completed nationally]
Danish: LISTE OVER HJÆLPESTOFFER [Udfyldes nationalt]
English: NAME OF THE MEDICINAL PRODUCT TRITAZIDE and associated names (see Annex I) 2.5 mg/12.5 mg tablets TRITAZIDE and associated names (see Annex I) 5 mg/12.5 mg tablets TRITAZIDE and associated names (see Annex I) 5 mg/25 mg tablets [See Annex I - to be completed nationally] ramipril/hydrochlorothiazide
Danish: TRITAZIDE og tilhørende navne (Se bilag I) 2,5 mg/12,5 mg tabletter TRITAZIDE og tilhørende navne (Se bilag I) 5 mg/12,5 mg tabletter TRITAZIDE og tilhørende navne (Se bilag I) 5 mg/25 mg tabletter [Se bilag I - Udfyldes nationalt] ramipril/hydrochlorothiazide
English: Slovenia: Tritazide 2.5 mg/12.5 mg tablete, Tritazide 5 mg/25 mg tablete
Danish: Slovenien: Tritazide 2.5 mg/12.5 mg tablete, Tritazide 5 mg/25 mg tablete
English: NAME OF THE MEDICINAL PRODUCT TRITAZIDE and associated names (see Annex I) 2.5 mg/12.5 mg tablets TRITAZIDE and associated names (see Annex I) 5 mg/12.5 mg tablets TRITAZIDE and associated names (see Annex I) 5 mg/25 mg tablets
Danish: TRITAZIDE and associated names (see Annex I) 2.5 mg/12.5 mg Tabletter TRITAZIDE and associated names (see Annex I) 5 mg/12.5 mg Tabletter TRITAZIDE and associated names (see Annex I) 5 mg/25 mg Tabletter
English: Poland
Danish: Polen:
English: (See also 5.3 'Preclinical safety data').
Danish: (se punkterne 4.3 og 4.4).
English: Poland: Tritace 2.5 Comb 2.5 mg/12.5 mg tabletki, Tritace 5 Comb 5 mg/25 mg tabletki
Danish: Tritace 2.5 Comb 2.5 mg/12.5 mg tabletki, Tritace 5 Comb 5 mg/25 mg tabletki
English: {Name and address} {Tel} {fax} {e-mail}
Danish: [Se bilag I - udfyldes nationalt] {Navn og adresse} {telefon} {fax} {e-mail}
English: Pharmacotherapeutic group: ramipril and diuretics, ATC code C09BA05
Danish: Terapeutisk klassifikation:C 09 BA 05 - ACE-hæmmere og diuretika
English: • Blood tests showing more potassium than usual in your blood.
Danish: Blodprøverresultater der viser mere kalium i blodet end normalt
English: P.O.
Danish: Se pkt.
English: In patients with hepatic cirrhosis the pharmacokinetics of hydrochlorothiazide has not changed significantly.
Danish: Farmakokinetikken for hydrochlorthiazid er ikke væsentligt anderledes hos patienter med levercirrhose.
English: BEFORE YOU TAKE TRITAZIDE
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE TRITAZIDE
English: In diabetic patients dosage adjustments of insulin or oral hypoglycaemic agents may be required.
Danish: Justering af medicin til behandling af diabetes, herunder insulin, kan være nødvendig.
English: Electrolyte imbalance
Danish: Elektrolyforstyrrelser
English: • Making it easier for your heart to pump blood around your body.
Danish: • Gør det lettere for dit hjerte at pumpe blodet rundt i din krop Hydroklorthiazid tilhører gruppen af lægemidler der kaldes ”tiazider” eller vanddrivende lægemidler.
English: • If you are having a test for parathyroid function.
Danish: • Skal have testet din biskjoldbruskkirtel.
English: Depending on the machine that is used,
Danish: Afhængigt af det apparatur der anvendes, kan det være uhensigtsmæssigt at anvende Tritace samtidig.
English: Significant activation of renin-angiotensin-aldosterone system is to be anticipated and medical supervision including blood pressure monitoring is necessary, for example in: - patients with severe hypertension - patients with decompensated congestive heart failure - patients with haemodynamically relevant left ventricular inflow or outflow impediment (e.g. stenosis of the aortic or mitral valve) - patients with unilateral renal artery stenosis with a second functional kidney - patients in whom fluid or salt depletion exists or may develop (including patients with diuretics) - patients with liver cirrhosis and/or ascites - patients undergoing major surgery or during anaesthesia with agents that produce hypotension.
Danish: Patienter med eksisterende salt og væskemangel eller kan opstå (inklusive patienter som anvender diuretika) Patienter med levercirrhose og/eller ascites Patienter planlagt til større operationer, eller under anæstesi med stoffer der medfører hypotension.
English: • This medicine has been prescribed for you.
Danish: - Lægen har ordineret Tritazide til dig personligt.
English: Very rare (affects less than 1 in 10,000 people)
Danish: Meget sjældne bivirkninger (forekommer hos færre end 1 ud af 10.000 patienter) Kvalme, diarré eller halsbrand
English: If necessary, the dose can be progressively increased to achieve target blood pressure; the maximum permitted doses are 10 mg of ramipril and 25 mg of hydrochlorothiazide daily”
Danish: De maksimale tilladte doser er 10 mg ramipiril og 25 mg hydrochlorothiazid dagligt."
English: - Hypersensitivity to the active substance or to any other ACE (Angiotensin Converting Enzyme) inhibitor, hydrochlorothiazide, other thiazide diuretics, sulfonamides or any of the excipients of TRITAZIDE (see section 6.1).
Danish: Overfølsomhed over de aktive stoffer eller over for et eller flere af de øvrige hjælpestoffer, eller andre ACE (Angiotensin Converting Enzyme)-hæmmere (se pkt.
English: • Swallow the tablets with liquid.
Danish: • Medicin der indeholder jod.
English: Unless continued ACE inhibitor/ AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Danish: Patienter der planlægger graviditet bør skiftes til alternativ antihypertensiv behandling, der besidder en etablereret sikkerhedsprofil for gravide, medmindre fortsat behandling med ACE-hæmmere/AIIRA betragtes som essentiel.
English: • Hair loss
Danish: Hårtab
English: Norway
Danish: Norge Polen
English: Slovak Republic: Tritazide 2.5 mg/12.5 mg tablety, Tritazide 5 mg/25 mg tablety
Danish: Slovakiet: Tritazide 2.5 mg/12.5 mg tablety, Tritazide 5 mg/25 mg tablety
English: • Medicines which can increase the amount of potassium in your blood such as spironolactone,
Danish: • Medicin der kan øge indholdet af kalium i blodet såsom spironolakton, triamterene, amilorid, kalium salte og heparin (blodfortyndende middel)
English: Czech Republic Tritazide 2.5 mg/12.5 mg tablety, Tritazide 5 mg/25 mg tablety
Danish: Tjekkiet: Tritazide 2.5 mg/12.5 mg tablety, Tritazide 5 mg/25 mg tablety
English: What TRITAZIDE looks like and contents of the pack Tablets [To be completed nationally] Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally] {Name and address} {tel} {fax} {email}
Danish: Indehaver af markedsføringstilladelsen [Se Bilag I - udfyldes nationalt] {Navn og adresse} {telefon} {fax} {e-mail}
English: vomiting and diarrhoea
Danish: Forstoppelse og smerter i maveregionen
English: Tests
Danish: Forholdsregler
English: • Change in the way things smell
Danish: Forstyrrelse af lugtesansen
English: • Take this medicine by mouth at the same time of day each day, usually in the morning.
Danish: Indtag medicinen gennem munden, på samme tidspunkt på dagen hver dag Slug tabletterne hele med rigelig væske Du må ikke tygge eller knuse tabletterne
English: Eye disorders
Danish: Tørre øjne
English: Whereas
Danish: i anamnesen
English: This could be a sign of a kidney problem (interstitial nephritis)
Danish: Dette kan være tegn på nyresygdom (interstitial nephritis) Højere sukkerindhold i urinen end normalt
English: PACKAGE LEAFLET
Danish: Lysskyhed
English: • Indigestion or feeling sick
Danish: Fordøjelsesbesvær og kvalme
English: • A swelling in your gut called “intestinal angioedema” presenting with symptoms like abdominal pain,
Danish: Hævelser, smerter og rødmen i kinden (betændelse af spytkirtlerne) Hævelse i tarmsystemet kaldet ”intestinal angiødem” der medfører symptomer som smerter i maveregionen, opkast og diarré
English: - History of hereditary or idiopathic angioedema - Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see section 4.5) - Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney - -2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6) - Lactation (see section 4.6) - Severe impairment of renal function with a creatinine clearance below 30 ml/min in undialysed patients - Clinically relevant electrolyte disturbances which may worsen following treatment with TRITAZIDE (see section 4.4) - Severe impairment of liver function, hepatic encephalopathy
Danish: 4.5) - Signifikant bilateral nyrearteriestenose eller nyrearteriestenose i en enkelt fungerende nyre - Graviditet i andet og tredje trimester (se pkt.
English: • Headache, feeling week or tired
Danish: Hovedpine eller træthedsfornemmelse
English: the CHMP has recommended the amendment of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Tritazide and associated names (see Annex I).
Danish: Produktresumé, etikettering og indlægsseddel fremgår af bilag III.
English: OTHER Monday Tuesday Wednesday Thursday Friday Saturday Sunday
Danish: Mandag Tirsdag Onsdag Torsdag Fredag Lørdag Søndag
English: These measures will help to protect the environment.
Danish: Disse foranstaltninger vil bidrage til at beskytte miljøet.
English: This will help you to remember to take it.
Danish: Dette vil hjælpe dig til at huske at tage den.
English: This will help get the best results for your health.
Danish: Det vil hjælpe med at opnå de bedste resultater for dit helbred.
English: However, try to take it at the same time each day.
Danish: Du bør dog forsøge at tage den på samme tidspunkt hver dag.
English: • Your doctor will prescribe the strength that is right for you.
Danish: • Din læge vil ordinere den styrke, der er den rigtige til dig.
English: Similar reductions were observed up to 104 weeks.
Danish: Tilsvarende reduktioner blev set i op til 104 uger.
English: The increased/decreased risk was not statistically significant in any of the organ systems.
Danish: Den øgede/reducerede risiko var ikke statistisk signifikant i nogen af organsystemerne.
English: The majority of these reactions were transient and reversible.
Danish: De fleste af disse reaktioner var forbigående og reversible.
English: A risk to the newborns/infants cannot be excluded.
Danish: Risiko for nyfødte/spædbørn kan ikke udelukkes.
English: Then take your next dose at the usual time.
Danish: Tag derpå den næste dosis på det sædvanlige tidspunkt.
English: Tablets are to be swallowed whole.
Danish: Tabletterne skal sluges hele.
English: Monitoring of renal function is recommended as follows:
Danish: Det anbefales at monitorere nyrefunktionen som følger:
English: Talk to your doctor about the best way to control your blood sugar while you are pregnant.
Danish: Tal med din læge om den bedste måde at kontrollere dit blodsukker på, mens du er gravid.
English: Do not stop taking Forxiga without talking to your doctor first.
Danish: Hold ikke op med at tage Forxiga uden først at tale med din læge.
English: These effects were sustained in longer-term trials.
Danish: Disse virkninger blev opretholdt i længerevarende studier.
English: Not all pack sizes may be marketed in your country.
Danish: Ikke alle pakningsstørrelser markedsføres nødvendigvis i dit land.
English: Forxiga can be taken orally once daily at any time of day with or without food.
Danish: Forxiga kan tages oralt én gang dagligt på et hvilket som helst tidspunkt af dagen med eller uden mad.
English: Mean duration of diabetes ranged from 1.4 to 16.9 years.
Danish: Den gennemsnitlige varighed af diabetes varierede fra 1,4 til 16,9 år.
English: There were no clinically relevant differences in systemic exposures between White, Black or Asian races.
Danish: Der var ingen klinisk relevante forskelle i systemiske eksponeringer mellem den hvide, sorte eller asiatiske race.
English: • Swallow the tablet whole with half a glass of water.
Danish: • Slug tabletten hel med et halvt glas vand.
English: • awakening from sleep at night to pass urine
Danish: • opvågnen om natten for at lade vandet
English: Especially tell your doctor:
Danish: Fortæl det altid til lægen:
English: Subjects (%) achieving:
Danish: Forsøgspersoner (%) der opnåede:
English: on one side and “1427” on the other side.
Danish: på den ene side og "1427" på den anden side.
English: Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs above.
Danish: Din læge vil fortælle dig, hvordan du skal behandle for lavt blodsukker, og hvad du skal gøre, hvis du får nogen af ovenstående tegn.
English: • These are medicines taken by mouth for diabetes.
Danish: • Det er medicin, som tages gennem munden for diabetes.
English: There are insufficient data to draw conclusions regarding exposure in patients > 70 years old.
Danish: Der foreligger ikke tilstrækkelige data til at drage konklusioner vedrørende eksponering hos patienter > 70 år.
English: It belongs to a group of medicines called “oral anti-diabetics”.
Danish: Det tilhører en gruppe medicin kaldet "orale antidiabetika".
English: Adverse reactions listed below are classified according to frequency and system organ class (SOC).
Danish: De nedenfor anførte bivirkninger er klassificeret efter hyppighed og systemorganklasse (SOC).
English: The safety and efficacy of dapagliflozin in children aged 0 to < 18 years have not yet been established.
Danish: Sikkerhed og effekt af dapagliflozin til børn i alderen 0 til < 18 år er endnu ikke klarlagt.
English: • The recommended dose is one 10 mg tablet each day.
Danish: • Den anbefalede dosis er én tablet på 10 mg dagligt.
English: Volume depletion b,e
Danish: Volumendepletering b,e
English: System organ class
Danish: SystemorganKlasse
English: • You can take your tablet with or without food.
Danish: • Du kan tage tabletten med eller uden mad.
English: • if you are 75 years old or older, you should not start taking Forxiga.
Danish: • Hvis du er over 75 år, bør du ikke begynde at tage Forxiga.
English: • You can take the tablet at any time of the day.
Danish: • Tabletten kan indtages når som helst på dagen.
English: Dapagliflozin was rapidly and well absorbed after oral administration.
Danish: Dapagliflozin blev hurtigt og godt absorberet efter oral indgivelse.
English: SGLT2 inhibitors should be used with caution in these patients.
Danish: SGLT2-hæmmere bør anvendes med forsigtighed til disse patienter.
English: None were found to be dose-related.
Danish: Ingen af dem blev påvist at være dosisrelaterede.
English: Paediatric population Interaction studies have only been performed in adults.
Danish: Pædiatrisk population Interaktionsstudier er kun udført hos voksne.
English: • if you have a history of serious heart disease or if you have had a stroke.
Danish: • Hvis har en sygehistorie med alvorlig hjertesygdom eller har haft et stroke.
English: • if you have “type 1 diabetes” - the type that usually starts when you are young, and your body does not produce any insulin.
Danish: • Hvis du har "type 1-diabetes" - den type, som sædvanligvis starter, når man er ung, og kroppen ikke producerer insulin.
English: Patients should be assessed for ketoacidosis immediately if these symptoms occur, regardless of blood glucose level.
Danish: Patienterne skal straks vurderes for ketoacidose, hvis disse symptomer opstår, uanset blodglucoseniveau.
English: This effect was observed at Week 1 of treatment and maintained in studies extended through Week 104.
Danish: Denne effekt blev observeret ved uge 1 af behandlingen og blev opretholdt i studierne op til og med uge 104.
English: Very common Common*
Danish: Meget almindelig Almindelig
English: • Prior to initiation of concomitant medicinal products that may reduce renal function and periodically thereafter
Danish: • Før start på behandling med samtidige lægemidler, der kan nedsætte nyrefunktionen, og periodisk derefter
English: • Your doctor may start you on a 5 mg dose if you have a liver problem.
Danish: • Din læge kan give dig en startdosis på 5 mg, hvis du har leverproblemer.
English: • changes in laboratory blood tests (for example creatinine or urea)
Danish: • ændringer i laboratorieblodprøver (f.eks. kreatinin eller urea)
English: However, an increased exposure due to age-related decrease in renal function can be expected.
Danish: Der kan dog forventes en forøget eksponering på grund af den aldersrelaterede nedgang i nyrefunktionen.
English: Forxiga is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients.
Danish: Børn og teenagere Forxiga frarådes til børn og teenagere under 18 år, da det ikke er blevet undersøgt hos disse patienter.
English: • Do not take a double dose of Forxiga to make up for a forgotten dose.
Danish: • Du må ikke tage en dobbeltdosis Forxiga som erstatning for den glemte dosis.
English: • For renal function approaching moderate renal impairment, at least 2 to 4 times per year.
Danish: • Ved udvikling af moderat nedsat nyrefunktion mindst 2-4 gange om året.
English: There is no clinically meaningful increase in exposure based on age alone in subjects up to 70 years old.
Danish: Der er ingen klinisk relevant øgning i eksponeringen baseret på alder alene hos forsøgspersoner op til 70 år.
English: • If it is 12 hours or more until your next dose, take a dose of Forxiga as soon as you remember.
Danish: • Hvis der er 12 timer eller mere til din næste dosis: Tag en dosis Forxiga, så snart du kommer i tanke om det.
English: If you have type 2 diabetes, your pancreas does not make enough insulin or your body is not able to use the insulin it produces properly.
Danish: Hvis du har type 2-diabetes, producerer din bugspytkirtel ikke nok insulin, eller kroppen kan ikke udnytte det insulin, som den producerer, godt nok.
English: In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient's clinical status.
Danish: I tilfælde af en overdosis skal der iværksættes passende understøttende behandling i henhold til patientens kliniske status.