natgillin/translations-raw huggingface dataset:
15 Hyperkaliæmi er blevet observeret hos en antal patienter i behandling med ACE- hæmmere inklusive TRITAZIDE.
Hyperkalaemia Hyperkalaemia has been observed in some patients treated with ACE inhibitors including TRITAZIDE.
4. 5).
If concomitant use of the above mentioned agents is deemed appropriate, regular monitoring of serum potassium is recommended (see section 4.5).
Hepatisk Encefalopati Elektrolytforstyrrelser pga af diuretikabehandling inklusive hydrochlorothiazid kan forårsage hepatisk encefalopati hos patienter med leversygdom.
Hepatic Encephalopathy Electrolyte disturbances due to diuretic therapy including hydrochlorothiazide may cause hepatic encephalopathy in patients with liver disease.
Hypercalkæmi Hydrochlorothiazid stimulerer calcium reabsorptionen og kan forårsage hypercalkæmi.
Hypercalcaemia Hydrochlorothiazide stimulates renal calcium reabsorption and may cause hypercalcaemia.
4. 8).
Angioedema Angioedema has been reported in patients treated with ACE inhibitors including ramipril (see section 4.8).
Intestinalt angioødem er blevet rapporteret hos patienter i behandling med ACE- hæmmere inklusive TRITAZIDE (se pkt.
Intestinal angioedema has been reported in patients treated with ACE inhibitors including TRITAZIDE (see section 4.8).
Anafylaktiske reaktioner under desensibilisering Sandsynligheden og sværhedsgraden af anafylaktisk og anafylaktoide reaktioner på insektgift og andre allergener er øget under ACE- hæmning.
Anaphylactic reactions during desensitization The likelihood and severity of anaphylactic and anaphylactoid reactions to insect venom and other allergens are increased under ACE inhibition.
Neutropeni/ agranulocytose Neutropeni/ agranulocytose, såvel som trombocytopeni og anæmi, er sjældent set og knoglemarvsdepression er også rapporteret.
Neutropenia/agranulocytosis Neutropenia/agranulocytosis have been rarely seen and bone marrow depression has also been reported.
4. 5 og 4. 8).
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).
Etniske forskelle ACE- hæmmere medfører en højere incidens af angioødem hos sorte patienter end hos ikke- sorte patienter.
Ethnic differences ACE inhibitors cause higher rate of angioedema in black patients than in non black patients.
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.
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.
Atleter Hydrochlorothiazider kan inducere et positivt resultat i antidoping test.
17 Athletes Hydrochlorothiazide may produce a positive analytic result in the anti-doping test.
Metaboliske og endokrine påvirkninger Thiazidbehandling kan påvirke glukosetolerancen.
Metabolic and endocrine effects Thiazide therapy may impair glucose tolerance.
Stigning i kolesterol - og triglyceridniveau kan være associeret med behandling med thiazider.
Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy.
Hoste
Cough Cough has been reported with the use of ACE inhibitors.
16 Hoste er blevet rapporteret ved anvendelse af ACE- hæmmere, Det er typisk en non- produktiv, vedvarende hoste, der forsvinder ved ophør af behandlingen.
Characteristically, the cough is non- productive, persistent and resolves after discontinuation of therapy.
ACE- hæmmerinduceret hoste skal betragtes som en differentialdiagnose til hoste.
ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough.
Andet Der kan ved thiazidbehandling forekomme allergiske reaktioner hos patienter, som ikke har eller har haft tilfælde af allergi eller astma bronchiale.
Other Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma.
Ekstrakorporale behandling der medfører blodkontakt med negativt ladede overflader såsom dialyse og hæmofiltrering med bestemte high- flux membraner (f. eks. polyakrylnitrilmembraner) og lavdensitets lipoprotein aferese med dextransulfat grundet øget risiko for anafylaktoide reaktioner (se pkt.
Extracorporeal treatments leading to contact of blood with negatively charged surfaces such as dialysis or haemofiltration with certain high-flux membranes (e.g. polyacrylonitril membranes) and low density lipoprotein apheresis with dextran sulphate due to increased risk of severe anaphylactoid reactions (see section 4.3).
4. 3) Hvis sådanne behandlinger er påkrævet bør det det overvejes at anvende en anden type dialysemembran eller en anden type antihypertensivum.
If such treatment is required, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent.
Forholdsregler
Precautions for use
Antihypertensiva (f. eks. diuretika) og andre stoffer der kan sænke blodtrykket (f. eks. nitrater, tricykliske antidepressiva, anæstetika, akut alkoholindtag, bacloren, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin):
Antihypertensive agents (e.g. diuretics) and other substances that may decrease blood pressure (e.g. nitrates, tricyclic antidepressants, anaesthetics, acute alcohol intake, baclofen, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin):
4. 2 for diuretika)
Potentiation of the risk of hypotension is to be anticipated (see section 4.2 for diuretics).
Vasopressor sympatomimetika og andre stoffer (f. eks. isoproterenol, dobutamin, dopamin, epinephrin) der kan reducere den antihypertensive effekt af TRITAZIDE:
Vasopressor sympathomimetics and other substances (epinephrine) that may reduce the antihypertensive effect of ramipril:
Der anbefales monitorering af blodtrykket.
Blood pressure monitoring is recommended.
Allopurinol, immunosuppressiva, kortikosteroider, procainamid, cytostatika og andre stoffer der kan ændre antallet af blodlegemer:
Allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics and other substances that may change the blood cell count.
4. 4).
Increased likelihood of haematological reactions (see section 4.4).
Lithiumsalte:
Lithium salts:
Udskillelsen af lithium kan reduceres med ACE- hæmmere, og derfor kan lithiumtoksicitet øges.
Excretion of lithium may be reduced by ACE inhibitors and therefore lithium toxicity may be increased.
Samtidig anvendelse af thiazid diuretika kan forøge risikoen for litiumforgiftning og forøge den allerede forøgede risiko for litiumforgiftning med ACE- hæmmer.
Concomitant use of thiazide diuretics may increase the risk of lithium toxicity and enhance the already increased risk of lithium toxicity with ACE inhibitors.
Antidiabetika inklusiv insulin:
18 Antidiabetic agents including insulin:
Hypoglykæmiske reaktioner kan opstå.
Hypoglycaemic reactions may occur.
Hydrochlorothiazid kan svække effekten af antidiabetisk medicin. Der anbefales derfor nøje monitorering af blodglukose i den initiale fase af samtidig administration.
Particularly close blood glucose monitoring is therefore recommended in the initial phase of co-administration.
Nonsteroide antiinflammatoriske stoffer og acetylsalicylsyre:
Nonsteroidal anti-inflammatory drugs and acetylsalicylic acid:
Reduktionen af den antihypertensive effekt af TRITAZIDE er forventelig.
Reduction of the antihypertensive effect of TRITAZIDE is to be anticipated.
Desuden kan samtidig behandling med ACE- hæmmere og NSAID’ er føre til øget risiko for forværret nyrefunktion og øget kaliæmi.
Furthermore, concomitant treatment of ACE inhibitors and NSAIDs may lead to an increased risk of worsening of renal function and to an increase in kalaemia.
Effekten af antikoagulanter kan nedsættes ved samtidig behandling med hydrochlorothiazid.
Oral anticoagulants: anticoagulant effect may be decreased due to concomitant use of hydrochlorothiazide.
Kortikosteroider, ACTH Amphotericin B, carbeoxolon, store mængder lakrids, laxativa (ved lang tids anvendelse) og andre kaliuretiske eller plasma kalium nedsættende stoffer: forøget risiko for hypokaliæmi.
Corticosteroids, ACTH, amphotericin B, carbenoxolone, large amounts of liquorice, laxatives (in case of a prolonged use), and other kaliuretic or plasma potassium decreasing agents: increased risk of hypokalaemia.
Deres proarytmiske effekt kan forøges eller deres antiarytmiske effekt nedsættes ved tilstedeværelse af elektrolytforstyrrelser (f. eks hypokalæmi eller hypomagnesia) -
Digitalis preparations, active substances known to prolong the QT interval and antiarrhythmics: their proarrhythmic toxicity may be increased or their antiarrhythmic effect decreased in the presence of electrolyte disturbances (e.g. hypokalaemia, hypomagnesaemia).
Methyldopa:
Methyldopa:
Hæmolyse er muligt.
Haemolysis possible.
Muskelafslappende midler af Curaretypen:
Curare-type muscle relaxants:
Mulig forøgelse og forlængelse af den muskelafslappende effekt.
Possible intensification and prolongation of the muscular relaxing effect.
Calciumsalte og plasma calcium forøgende stoffer.
Calcium salts and plasma calcium increasing medicinal products:
Derfor er tæt kontrol af serum calcium nødvendig.
Rise in serum calcium concentration is to be anticipated in case of concomitant administration of hydrochlorothiazide; therefore close monitoring of serum calcium is required.
Af den additive effect med hydrochlorothiazide.
Carbamazepine: risk of hyponatraemia due to additive effect with hydrochlorothiazide.
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.
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.
HydroChlorothiazid udskilles i distla tubulus og reducerer udskillelsen af penicillin.
Penicillin: hydrochlorothiazide is excreted in the distal tubulus, and reduces excretion of penicillin.
Hydrochlorothiazid reducerer quinine udskillelsen
Quinine: hydrochlorothiazide reduces quinine excretion.
(se punkterne 4. 3 og 4. 4).
TRITAZIDE is not recommended during the first trimester of pregnancy (see section 4.4) and contraindicated during the second and third trimesters of pregnancy (see section 4.3).
Epidemiologiske undersøgelser af risikoen for teratogenitet ved behandling med ACE- hæmmere under graviditetens første trimester er inkonklusive, men en lille forøget risiko kan ikke udelukkes.
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.
Ved planlægning af graviditet bør patienten overgå til alternativ antihypertensiv behandling med en kendt sikkerhedsprofil vedrørende brug under graviditet, med mindre fortsat behandling med ACE - hæmmere vurderes at være nødvendig.
Unless continued ACE inhibitor 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.
Ved påvist graviditet bør behandling med ACE- hæmmere seponeres omgående, og alternativ antihypertensiv behandling eventuelt indledes.
When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.
Det er kendt, at eksponering for ACE- hæmmere/ Angiotensin II Receptor Antagonister i graviditetens andet og tredje trimester forårsager human føtotoksicitet (nedsat nyrefunktion, oligohydramnion, forsinket ossifikation af kraniet) og neonatal toksicitet (nyreinsufficiens, hypotension, hyperkaliæmi) (se også pkt.
ACE inhibitor/ Angiotensin II Receptor Antagonist (AIIRA) therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
5. 3).
(See 19 also 5.3'Preclinical safety data').
Ved eksponering for ACE- hæmmere i andet eller tredje trimester anbefales ultralydsscanning af fosterets nyrefunktion og kranium.
Should exposure to ACE inhibitor have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Børn, hvis mødre har taget ACE- hæmmere, bør observeres nøje for hypotension, oliguri og hyperkaliæmi (se punkt 4. 3 og 4. 4).
Newborns whose mothers have taken ACE inhibitors should be closely observed for hypotension, oliguria and hyperkalaemia (see also sections 4.3 and 4.4).
Hydrochlorthiazid kan forårsage føto- placental iskæmi og risiko for væksthæming i tilfælde af forlænget eksponering under tredje trimester af graviditeten.
Hydrochlorothiazide, in cases of prolonged exposure during the third trimester of pregnancy, may cause a foeto-placental ischaemia and risk of growth retardation.
5. 2), og der anbefales derfor alternativ behandling med bedre etableret sikkerhedsprofil under amning, særligt ved amning af nyfødte eller for tidligt fødte børn.
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.
Der kan opstå hypokaliæmi og nuklear icteus ved
Thiazides during breast-feeding by lactating mothers have been associated with a decrease or even suppression of lactation.
18 overfølsomhed overofr sulfonamidderivater.
Hypersensitivity to sulphonamide-derived active substances, hypokalaemia and nuclear icterus might occur.
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.).
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).
Sikkerhedsprofilen for ramipril + hydrochlorothiazide inkluder bivirkninger der skyldes hypotension og/ eller væskemangel efter øget diuresis..
The safety profile of ramipril + hydrochlorothiazide includes adverse reactions occurring in the context of hypotension and/or fluid depletion due to increased 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..
The two active substances have inverse effects on plasma potassium.
Alvorlige bivirkninger inkluderer angioødeedem, anafylaktisk reationer, renal eller hepatisk svækkelse, pancreatitis, alvorlige hudreaktioner og neutropeni/ agranulocytose.
Serious adverse reactions include angioedema or anaphylactic reaction, renal or hepatic impairment, pancreatitis, severe skin reactions and neutropenia/agranulocytosis.
Hyppigheden af bivirkningerne er defineret ud fra følgende konvention:
Adverse reactions frequency is defined using the following convention:
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).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Meget sjælden
Common
Ikke kendt
Uncommon Myocardial ischaemia including angina pectoris, tachycardia, arrhythmia, palpitations, oedema peripheral
Hjerte
Very rare
Myokardie infarkt
Not known Myocardial infarction
Blod og lymfesystem
20 Blood and lymphatic system disorders
Øjne Synsforstyrrelser
Eye disorders
inklusiv sløret syn konjunktivitis
Visual disturbance including blurred vision, conjunctivitis
Høreforstyrrelser
Hearing impaired
19 Lidelser I luftveje, thorax og mediastinum
Respiratory, thoracic and mediastinal disorders
Bronkospasme inklusiv forværring af astma Alveolitisk allergi, non cardiogen lungeødem pga hydroklorthiazid
Bronchospasm including asthma aggravated Alveolitis allergic, non cardiogenic pulmonary oedema due to hydrochlorothiazide
Gastrointestinal betændelse, fordøjelses forstyrrelser, abdominal ubehag, dyspepsi, gastritis,
Gastrointestinal inflammation, digestive disturbances, abdominal discomfort, dyspepsia, gastritis, nausea, constipation
Opkast, aphtous stomatitis, glossitis, diarré, abdominal
Vomiting, aphtous stomatitis, glossitis, diarrhoea, abdominal pain upper, dry mouth
Sialoadenitis pga
Gingivitis due to hydrochlorothiazide
Gingivitis due pga hydroklorthiazid
Sialoadenitis due to hydrochlorothiazide
Renal inklusiv akut nyresvigt, øget urinsekretion, øget
Renal and urinary disorders
urinsyreindhold I blodet, blod kreatinine forhøjet
Renal impairment including renal failure acute, urine output increased, blood urea increased, blood creatinine increased 21
Interstitial nephritis pga hydroklorothiazide
Worsening of a pre- existing proteinuria Interstitial nephritis due to hydrochlorothiazide
I meget sjældne tilfælde kan luftvejsobstruktionen forårsaget af angioødem have dødelig udgang; dermatitis psoriasiform, hyperhidrosis, rødme, især makulo -
Angioedema: very exceptionally, the airway obstruction resulting from angioedema may have a fatal outcome; dermatitis psoriasiform, hyperhidrosis, rash, in particular maculo-papular, pruritus, alopecia
Toxisk epidermal nekrolyse, Stevens- Johnson syndrom, erythem multiform, pemphigus, psoriasis forværret, exfoliative dermatitis, photosensitivity reaktion, onycholysis, pemphigoid eller lichenoid exanthema eller enanthema, urticaria
Toxic epidermal necrolysis, Stevens- Johnson syndrome, erythema multiforme, pemphigus, psoriasis aggravated, exfoliative dermatitis, photosensitivity reaction, onycholysis, pemphigoid or lichenoid exanthema or enanthema, urticaria
Arthralgia, muskel spasms Muskulær svækkelse, muskuloskeletal stivhed, tetani pga hydrochlorothiazide
Arthralgia, muscle spasms Muscular weakness, musculoskeletal stiffness, tetany due to hydrochlorothiazide
Diabetes mellitus utilstrækkelig kontrol, glukose
Diabetes mellitus inadequate control, glucose tolerance
Blood kalium forhøjet pga
Blood potassium increased due
Blod natrium nedsat Glycosuri, metabolisk
Blood sodium decreased
tolerance nedsat, blod glukose nedsat, blod urin syre forhøjet, podagra forværret, blod kolesterol
decreased, blood glucose increased, blood uric acid increased, gout aggravated, blood cholesterol and/or triglycerides increased due to hydrochlorothiazide
ramipril
to ramipril
og/ eller triglycerider forhøjet pga hydrochlorothiazide
Glycosuria, metabolic alkalosis, hypochloraemia, hypomagnesaemia, hypercalcaemia, dehydration due to hydrochlorothiazide
Thrombose efter alvorlig hypokaliæmi, vaskulær stenose, hypoperfusion, Raynaud’ s fænomen, vaskulitis
Thrombosis in the context of severe fluid depletion, vascular stenosis, hypoperfusion, Raynaud’s phenomenon, vasculitis
Almene symptomer og reaktioner på administrationsstedet
22 General disorders and administration site conditions
Brystsmerter, feber
Chest pain, pyrexia
Kolestatisk eller cytolytisk hepatitis (I meget få tilfælde med dødelig udgang)), Hepatisk enzyme og/ eller bilirubin forhøjet
Cholestatic or cytolytic hepatitis (fatal outcome has been very exceptional), hepatic enzyme and /or bilirubin conjugated increased
Symptomerne på overdosering af ACE- hæmmere kan være kraftig perifer vasodilation (med kraftig hypotension, chok) bradykardi, elektrolytforstyrrelser nyreinsufficiens, hjertearytmier, svækket bevidsthed inklusiv koma, cerebrale kramper, pareser og paralytisk ileus.
Symptoms associated with overdosage of ACE inhibitors may include excessive peripheral vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, renal failure, cardiac arrhythmia, impairment of consciousness including coma, cerebral convulsions, pareses, and paralytic ileus.
Hos prædisponerede patienter (f. eks. prostata hyperplasi) kan hydrochlorthiazid medføre akut urinretention.
In predisposed patients (e.g. prostatic hyperplasia) hydrochlorothiazide overdose may induce acute urinary retention.
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).
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.
21 5.
23 5.
Terapeutisk klassifikation: C 09 BA 05 – ACE- hæmmere og diuretika
Pharmacotherapeutic group: ramipril and diuretics, ATC code C09BA05
Angiotensin- converting enzyme, kininase II).
Ramipril Ramiprilat, the active metabolite of the prodrug ramipril, inhibits the enzyme dipeptidylcarboxypeptidase I (synonyms: angiotensin-converting enzyme; kininase II).
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.
The average response to ACE inhibitor monotherapy was lower in black (Afro- Caribbean) hypertensive patients (usually a low-renin hypertensive population) than in non-black patients.
Hydrochlorthiazid er et thiaziddiuretikum.
Hydrochlorothiazide Hydrochlorothiazide is a thiazide diuretic.
Ændret natriumbalance, reduktion af ekstracellulært vand og plasmavolumen, ændring i den renale vaskulære modstand såvel som et reduceret respons overfor noradrenalin og angiotensin II.
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.
Ramipril Administration af ramipril forårsager en udtalt reduktion i den periferalee arterielle modstand.
Ramipril Administration of ramipril causes a marked reduction in peripheral arterial resistance.
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.
Generally, there are no major changes in renal plasma flow and glomerular filtration rate.
Hos de fleste patienter ses den antihypertensive effekt fra behandlingsstart med en enkelt dosis 1 til 2 timer efter oral administration.
Administration of ramipril to patients with hypertension leads to a reduction in supine and standing blood pressure without a compensatory rise in heart rate.
Den antihypertensive virkning af en enkelt dosis varer sædvanligvis 24 timer.
In most patients the onset of the antihypertensive effect of a single dose becomes apparent 1 to 2 hours after oral administration.
Maximum effekt af en enkelt dosis nås almindeligvis fra 3 til 6 timer efter oral administration.
The peak effect of a single dose is usually reached 3 to 6 hours after oral administration.
2 timer efter administration og maksimum nås efter 3- 6 timer og varer 6- 12 timer.
Hydrochlorothiazide With hydrochlorothiazide, onset of diuresis occurs in 2 hours, and peak effect occurs at about 4 hours, while the action persists for approximately 6 to 12 hours.