natgillin/translations-raw huggingface dataset:
Elektrolytforstyrrelser Elektrolytforstyrrelser er almindeligt forekommende hos patienter med nyreinsufficiens, med eller uden diabetes, og bør behandles.
Electrolyte imbalances Electrolyte imbalances are common in patients with renal impairment, with or without diabetes, and should be addressed.
Derfor bør kaliums plasmakoncentration såvel som kreatininclearance monitoreres tæt, især patienter med hjertesvigt og kreatininclearance på 30- 50 ml/ min bør monitoreres tæt.
Therefore, the plasma concentrations of potassium and creatinine clearance values should be closely monitored; especially patients with heart failure and a creatinine clearance between 30-50 ml/ min should be closely monitored.
4. 5).
The concomitant use of potassium sparing diuretics, potassium supplements and potassium containing salt substitutes with losartan/ hydrochlorothiazide is not recommended (see section 4.5).
Leverinsufficiens Baseret på farmakokinetiske data, som viser signifikant forhøjede plasmakoncentrationer af losartan hos cirrhotiske patienter, bør Cozaar Comp. anvendes med forsigtighed hos patienter med mild til moderat leverinsufficiens i anamnesen.
Liver function impairment Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of losartan in cirrhotic patients, Cozaar Comp should be used with caution in patients with a history of mild to moderate hepatic impairment.
4. 2, 4. 3 og 5. 2).
Therefore Cozaar Comp is contraindicated in patients with severe hepatic impairment (see sections 4.2, 4.3 and 5.2).
Nyreinsufficiens Som følge af hæmningen af renin- angiotensinsystemet, er der rapporteret forandringer i nyrefunktionen herunder nyresvigt (især hos patienter hvis nyrefunktion er afhængig af renin- angiotensin - aldosteronsystemet som patienter med svær hjerteinsufficiens eller tidligere nedsat nyrefunktion).
Renal function impairment As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function, including renal failure, have been reported (in particular, in patients whose renal function is dependent on the renin-angiotensin-aldosterone system, such as those with severe cardiac insufficiency or pre-existing renal dysfunction).
Som for andre lægemidler, der påvirker renin- angiotensin- aldosteronsystemet, er der rapporteret om øget carbamid og serumkreatinin hos patienter med bilateral nyrearteriestenose eller unilateral nyrearteriestenose (hvis funktionelt ennyret); disse ændringer i nyrefunktionen kan være reversible ved seponering af behandlingen.
As with other drugs that affect the renin-angiotensin-aldosterone system, increases in blood urea and serum creatinine have also been reported in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney; these changes in renal function may be reversible upon discontinuation of therapy.
21 Primær hyperaldosteronisme Patienter med primær hyperaldosteronisme vil generelt ikke respondere på antihypertensiva, der virker ved hæmning af renin- angiotensinsystemet.
Primary hyperaldosteronism Patients with primary aldosteronism generally will not respond to antihypertensive drugs acting through inhibition of the renin-angiotensin system.
Koronar hjertesygdom og cerebrovaskulær sygdom Som det er tilfældet med andre antihypertensiva kan et kraftigt fald i blodtrykket hos patienter med iskæmisk kardiovaskulær og cerebrovaskulær sygdom medføre myokardieinfarkt eller stroke.
22 As with any antihypertensive agents, excessive blood pressure decrease in patients with ischaemic cardiovascular and cerebrovascular disease could result in a myocardial infarction or stroke.
Hjerteinsufficiens Hos patienter med hjerteinsufficiens, med eller uden nyreinsufficiens, er der, som med andre lægemidler der påvirker renin- angiotensinsystemet, risiko for svær arteriel hypotension og (ofte akut) nyreinsufficiens.
In patients with heart failure, with or without renal impairment, there is - as with other drugs acting on the renin-angiotensin system - a risk of severe arterial hypotension, and (often acute) renal impairment.
Aorta - og mitralklapstenose, obstruktiv hypertrofisk kardiomyopati Som det er tilfældet med andre vasodilatorer er særlig forsigtighed indiceret hos patienter, der har aorta - eller mitralstenose eller obstruktiv hypertrofisk kardiomyopati.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyophathy As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Etniske forskelle Som det blev bemærket i forbindelse med angiotensinkonverterende enzymhæmmere er losartan og de andre angiotensinantagonister tilsyneladende mindre effektive til sænkning af blodtrykket hos negroide personer i forhold til ikke- negroide, muligvis på grund af større prævalens af lavrenin tilstande i den negroide hypertensive population.
Ethnic differences As observed for angiotensin converting enzyme inhibitors, losartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non- blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.
Graviditet Behandling med Cozaar Comp. bør ikke initieres under graviditet.
Pregnancy Cozaar Comp should not be initiated during pregnancy.
Med mindre fortsat behandling med losartan/ hydrochlorthiazid anses for essentiel, bør patienter, der planlægger graviditet, skiftes til alternativ antihypertensiv behandling, som har en etableret sikkerhedsprofil for anvendelse under graviditet.
Unless continued Losartan/ HTCZ 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.
4. 3 og 4. 6).
When pregnancy is diagnosed, treatment with Cozaar Comp should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Hypotension og elektrolyt - / væskeforstyrrelser Som det er tilfældet med al antihypertesniv behandling kan hypotension forekomme hos nogle patienter.
Hypotension and electrolyte/ fluid imbalance As with all antihypertensive therapy, symptomatic hypotension may occur in some patients.
Patienterne bør observeres for kliniske tegn på væske - eller elektrolytforstyrrelser, f. eks. væskemangel, hyponatriæmi, hypochloræmisk alkalose, hypomagnesiæmi eller hypokaliæmi, som kan forekomme ved tilstødende diarré eller opkastning.
Patients should be observed for clinical signs of fluid or electrolyte imbalance, e. g., volume depletion, hyponatremia, hypochloremic alkalosis, hypomagnesemia or hypokalemia which may occur during intercurrent diarrhea or vomiting.
Metaboliske og endokrine påvirkninger Thiazidbehandling kan påvirke glucosetolerancen.
Metabolic and endocrine effects Thiazide therapy may impair glucose tolerance.
4. 5).
Dosage adjustment of antidiabetic agents, including insulin, may be required (see section 4.5).
Stigning i kolesterol - og triglyceridkoncentration kan være associeret med behandling med thiazider.
Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.
Thiazidbehandling kan fremskynde hyperurikæmi og/ eller arthritis urica hos nogle patienter.
Thiazide therapy may precipitate hyperuricemia and/ or gout in certain patients.
Da losartan nedsætter urinsyremængden, dæmper losartan i kombination med hydrochlorthiazid den diuretikainducerede hyperurikæmi.
Because losartan decreases uric acid, losartan in combination with hydrochlorothiazide attenuates the diuretic- induced hyperuricemia.
Thiazider bør anvendes med forsigtighed til patienter med nedsat leverfunktion eller progressiv leversygdom, da mindre ændringer i væske - og elektrolytbalancen kan udløse hepatisk koma.
Hepatic impairment Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, as it may cause intrahepatic cholestasis, and since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
4. 3 og 5. 2).
Cozaar Comp is contraindicated for patients with severe hepatic impairment (see section 4.3 and 5.2).
Andet Der kan ved thiazidbehandling forekomme allergiske reaktioner hos patienter, som ikke har eller har haft tilfælde af allergi eller astma bronchiale.
23 Other In patients receiving thiazides, hypersensitivity reactions may occur with or without a history of allergy or bronchial asthma.
6. 1).
Excipient Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine (see section 6.1).
Som ved andre stoffer, der blokerer angiotensin- II eller dets virkning, kan samtidig brug af kaliumbesparende diuretika (f. eks. spironolacton, triamteren, amilorid), kaliumtilskud eller kaliumholdige salterstatninger medføre stigninger i serumkalium.
As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e. g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium.
Derfor bør serumlithiumkoncentrationen monitoreres omhyggeligt, hvis lithiumsalte administreres sammen med angiotensin II- receptorantagonister.
Therefore, serum lithium levels should be monitored carefully if lithium salts are to be co- administered with angiotensin II receptor antagonists.
Når angiotensin II- antagonister administreres samtidigt med NSAID (dvs. selektive COX- 2 hæmmere, acetylsalicylsyre i antiinflammatoriske doser og non- selektive NSAID) kan afsvækning af den antihypertensive virkning forekomme.
When angiotensin II antagonists are administered simultaneously with NSAIDs (i. e. selective COX-2 inhibitors, acetylsalicylic acid at anti-inflammatory doses) and non-selective NSAIDs, attenuation of the antihypertensive effect may occur.
Samtidig anvendelse af angiotensin II- antagonister eller diuretika og NSAID kan medføre øget risiko for forværring af nyrefunktionen, herunder mulig akut nyresvigt og stigning i serumkalium, især hos patienter med eksisterende dårlig nyrefunktion.
Concomitant use of angiotensin II antagonists or diuretics and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
Hos nogle patienter med kompromitteret nyrefunktion, og som bliver behandlet med NSAID, herunder selektive COX- 2- hæmmere, kan samtidig administration angiotensin II- receptorantagonister resultere i en yderligere forværring af nyrefunktionen.
In some patients with compromised renal function who are being treated with non-steroidal anti- inflammatory drugs, including selective cyclooxygenase-2 inhibitors, the co-administration of angiotensin II receptor antagonists may result in a further deterioration of renal function.
Andre stoffer, der kan inducere hypotension, som tricykliske antidepressiva, antipsykotika, baclofen, amifostin:
Other substances inducing hypotension like tricyclic antidepressants, antipsychotics, baclofene, amifostine:
Samtidig anvendelse af disse lægemidler, der som hoved - eller sideeffekt sænker blodtrykket, kan øge risikoen for hypotension.
Concomitant use with these drugs that lower blood pressure, as main or side-effect, may increase the risk of hypotension.
Alkohol, barbiturater, narkotiske stoffer eller antidepressiva Potensering af orthostatisk hypotension kan forekomme.
Potentiation of orthostatic hypotension may occur.
23 Antidiabetika (orale lægemidler eller insulin) Behandling med thiazid kan påvirke glucosetolerancen.
The treatment with a thiazide may influence the glucose tolerance.
Andre antihypertensiva Additiv virkning.
24 Other antihypertensive drugs Additive effect.
Cholestyramin og colestipolresiner Absorptionen af hydrochlorthiazid er nedsat i forbindelse med anionbytterresiner.
Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
Enkeltdoser cholestyramin eller colestipol binder hydrochlorthiaziden og reducerer absorptionen af denne fra mave- tarmkanalen med op til henholdsvis 85% og 43%.
Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively.
Pressoraminer (f. eks. adrenalin) Mulig nedsættelse af respons på pressoraminer, men ikke tilstrækkelig til at udelukke anvendelsen.
Pressor amines (e. g., adrenaline) Possible decreased response to pressor amines but not sufficient to preclude their use.
Skeletale muskelafslappende stoffer, nondepolariserende (f. eks. tubocurarin) Mulighed for forøget respons på muskelafslappende stoffer.
Skeletal muscle relaxants, nondepolarizing (e. g., tubocurarine) Possible increased responsiveness to the muscle relaxant.
Lithium Diuretika reducerer den renale udskillelse af lithium og kan medføre høj risiko for lithiumforgiftning; samtidig anvendelse anbefales ikke.
Lithium Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity; concomitant use is not recommended.
Lægemidler til behandling af arthritis urica (probenecid, sulfinpyrazon og aalopurinol) Dosisjustering af urikosuriske lægemidler kan være nødvendig, da hydrochlorthiazid kan øge koncentrationen af serumurinsyre.
Medicinal products used in the treatment of gout (probenecid, sulfinpyrazone and allopurinol) Dosage adjustment of uricosuric medicinal products may be necessary since hydrochlorothiazide may raise the level of serum uric acid.
Antikolinerge lægemidler (f. eks. atropin, biperiden) Stigning i biotilgængelighed over for thiazidtypediuretika ved at nedsætte den gastrointestinale motilitet samt mavetømningshastigheden.
Anticholinergic agents (e. g. atropine, biperiden) Increase of the bioavailability to thiazide-type diuretics by decreasing gastrointestinal motility and stomach emptying rate.
Cytotoksiske lægemidler (f. eks. cyclophosphamid, methotrexat) Thiazider kan reducere den renale ekskretion af cytotoksiske lægemidler og styrke deres myelosuppressive effekt.
Cytotoxic agents (eg cyclophosphamide, methotrexate) Thiazides may reduce the renal excretion of cytotoxic medicinal products and potentiate their myelosuppressive effects.
Salicylater I tilfælde af høje doser af salicylater kan hydrochlorthiazid forstærke salicylaternes toksiske effekt på centralnervesystemet.
Salicylates In case of high dosages of salicylates hydrochlorothiazide may enhance the toxic effect of the salicylates on the central nervous system.
Methyldopa Der har været isolerede rapporter om hæmolytisk anæmi, som forekommer ved samtidig anvendelse af hydrochlorthiazid og methyldopa.
Methyldopa There have been isolated reports of haemolytic anaemia occurring with concomitant use of hydrochlorothiazide and methyldopa.
Cyclosporin Samtidig behandling med cyclosporin kan øge risikoen for hyperurikæmi og komplikationer af arthritis uricatypen.
Cyclosporine Concomitant treatment with cyclosporine may increase the risk of hyperuricaemia and gout-type complications.
Digitalisglycosider Thiazidinduceret hypokaliæmi eller hypomagnesiæmi kan fremme forekomst af digitalisinduceret hjertearytmi.
Digitalis glycosides Thiazide-induced hypokalaemia or hypomagnesaemia may favour the onset of digitalis-induced cardiac arrhythmias.
24 Lægemidler der påvirkes af serumkaliumforstyrrelser Periodisk monitorering af serumkalium og EKG anbefales, når losartan/ hydrochlorthiazid administreres sammen med lægemidler, der påvirkes af serumkaliumforstyrrelser (f. eks. digitalisglycosider og antiarytmika) og med følgende torsade de pointes (ventrikulær takykardi) inducerende lægemidler (inklusive nogle antiarytmika), idet hypokaliæmi er en disponerende faktor for torsades de pointes (ventrikulær takykardi):
25 (ventricular tachycardia)-inducing medicinal products (including some antiarrhythmics), hypokalaemia being a predisposing factor to torsades de pointes (ventricular tachycardia):
• Klasse Ia antiarytmika (f. eks. quinidin, hydroquinidin, disopyramid). • Klasse III antiarytmika (f. eks. amiodaron, sotalol, dofetilid, ibutilid). • Nogle antipsykotika (f. eks. thioridazin, chlorpromazin, levomepromazin, trifluperazin, cyamemazin, sulpirid, sultoprid, amisulprid, tiaprid, pimozid, haloperidol, droperidol). • Andre (f. eks. bepridil, cisaprid, diphemanil, erythromycin IV, halofantrin, mizolastin, pentamidin, terfenadin, vincamin IV).
• Class Ia antiarrythmics (eg quinidine, hydroquinidine, disopyramide). • Class III antiarrythmics (eg amiodarone, sotalol, dofetilide, ibutilide). • Some antipsychotics (eg thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol). • Others (eg bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin, pentamidine, terfenadine, vincamine IV).
Kalciumsalte Thiaziddiuretika kan øge serumcalciumkoncentrationen på grund af nedsat ekskretion.
Calcium salts Thiazide diuretics may increase serum calcium levels due to decreased excretion.
4. 4).
Laboratory Test Interactions Because of their effects on calcium metabolism, thiazides may interfere with tests for parathyroid function (see section 4.4).
Jodholdige kontrasstoffer I tilfælde af diuretikainduceret dehydrering er der øget risiko for akut nyresvigt, især ved høje doser af jodpræparatet.
Iodine Contrast Media In case of diuretic-induced dehydration, there is an increased risk of acute renal failure, especially with high doses of the iodine product.
4. 4).
Pregnancy The use of Cozaar Comp is not recommended during the first trimester of pregnancy (see section 4.4).
4. 3 og 4. 4).
The use of Cozaar Comp is contra-indicated during the 2nd and 3rd trimester of pregnancy (see section 4.3 and 4.4).
Epidemiologisk evidens for risiko for teratogenicitet efter eksponering for ACE- hæmmere i 1. trimester af graviditeten har ikke været konklusive; en lille risikostigning kan dog 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.
Selvom der ikke findes kontrollerede epidemiologiske data vedrørende risikoen ved angiotensin II - receptorhæmmere (AIIRAer), kan de samme risici være forbundet med denne lægemiddelklasse.
Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Inhibitors (AIIRAs), similar risks may exist for this class of drugs.
Med mindre fortsat ARB- behandling anses for at være essentiel, bør patienter, der planlægger graviditet, skiftes til alternative anithypertensive behandlinger, som har en etableret sikkerhedsprofil for anvendelse under graviditet.
Unless continued ARB 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.
5. 3).
Cozaar Comp 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) (see also 5.3'Preclinical safety data ').
4. 3 og 4. 4).
Infants whose mothers have taken Cozaar Comp should be closely observed for hypotension (see also section 4.3 and 4.4).
Hydrochlorthiazid kan reducere både plasmavolumen og blodgennemstrømningen i livmoder/ placenta.
Hydrochlorothiazide may reduce both plasma volume and uteroplacental blood flow.
De kan medføre
They may cause fetal electrolyte disturbances and
25 føtale elektrolytforstyrrelser og muligvis andre reaktioner, som er blevet observeret hos voksne.
26 possibly other reactions that have been observed in adults.
Amning Det vides ikke, om losartan udskilles i modermælken hos mennesker.
Lactation It is not known whether losartan is excreted in human milk.
4. 3).
Because of the potential for adverse effects on the nursing infant, Cozaar Comp is contraindicated during breast-feeding (see section 4.3).
Bivirkningerne nedenfor er klassificeret, hvor dette er hensigtsmæssigt, i henhold til systemorganklasser og frekvens i overensstemmelse med følgende konvention:
The adverse events below are classified where appropriate by system organ class and frequency according to the following convention:
≥1/ 10 ≥1/ 100, < 1/ 10 ≥1/ 1. 000, ≤1/ 100 ≥1/ 10. 000, ≤1/ 1. 000 ≤1/ 10. 000 ≤1/ 10. 000
≥ 1/ 100, < 1/ 10 ≥ 1/ 1,000, ≤ 1/ 100 ≥ 1/ 10,000, ≤ 1/ 1,000 ≤ 1/ 10,000 ≤ 1/ 10,000
Der er i kliniske undersøgelser med losartankalium- hydrochlorthiazid ikke observeret bivirkninger specielt associeret til kombinationsbehandlingen.
In clinical trials with losartan potassium salt and hydrochlorothiazide, no adverse events peculiar to this combination of substances were observed.
Bivirkningerne var begrænset til dem, som tidligere er rapporteret ved behandling med losartankalium og/ eller hydrochlorthiazid.
The adverse events were restricted to those which were formerly observed with losartan potassium salt and/ or hydrochlorothiazide.
Disse er:
Next to these effects, there are further adverse reactions reported after the introduction of the product to the market as follows:
Lever og galdeveje Sjælden:
Hepato-biliary disorders Rare:
Hyperkaliæmi, stigning i ALAT.
Hyperkalaemia, elevation of ALT
Yderligere bivirkninger, som er set med en af komponenterne, og som kan være mulige bivirkninger ved losartankalium/ hydrochlorthiazid er følgende:
Additional adverse events that have been seen with one of the individual components and may be potential adverse events with losartan potassium/ hydrochlorothiazide are the following:
Anæmi, Schönlein- Henochs purpura, ekkymose, hæmolyse.
Anaemia, Henoch-Schönlein purpura, ecchymosis, haemolysis
26 Immunsystemet Sjælden:
Immune system disorders Rare:
Anafylaktiske reaktioner, angioødem, urticaria.
Anaphylactic reactions, angioedema, urticaria
Metabolisme og ernæring Ikke almindelig:
27 Metabolism and nutrition disorders Uncommon:
Anoreksi, arthritis urica.
Anorexia, gout
Insomnia.
Insomnia Uncommon:
Ikke almindelig: angst, angstforstyrrelser, panikangst, forvirring, depression, unormale drømme, søvnforstyrrelser, somnolens, hukommelsessvækkelse.
Anxiety, anxiety disorder, panic disorder, confusion, depression, abnormal dreams, sleep disorder, somnolence, memory impairment
Ikke almindelig:
Headache, dizziness Uncommon:
Nervøsitet, paræstesi, perifer neuropati, tremor, migræne, synkope.
Nervousness, paraesthesia, peripheral neuropathy, tremor, migraine, syncope
Sløret syn, brænden/ stikken i øjnene, konjunktivitis, nedsat synsskarphed.
Blurred vision, burning/ stinging in the eye, conjunctivitis, decrease in visual acuity
Vertigo, tinnitus.
Vertigo, tinnitus
Hypotension, orthostatisk hypotension, sternalgi, angina pectoris, AV- blok af 2. grad, cerebrovaskulær hændelse, myokardieinfarkt, palpitation, arytmi (atrieflimren, sinusbradykardi, takykardi, ventrikulær takykardi, ventrikelflimren).
Hypotension, orthostatic hypotension, sternalgia, angina pectoris, grade II-AV block, cerebrovascular event, myocardial infarction, palpitation, arrhythmias (atrial fibrillations, sinus bradycardia, tachycardia, ventricular tachycardia, ventricular fibrillation)
Vasculitis.
Vasculitis
Ikke almindelig:
Cough, upper respiratory infection, nasal congestion, sinusitis, sinus disorder Uncommon:
Gener i svælget, pharyngitis, laryngitis, dyspnø, bronkitis, epistaksis, rhinitis, respiratorisk kongestion.
Pharyngeal discomfort, pharyngitis, laryngitis, dyspnoea, bronchitis, epistaxis, rhinitis, respiratory congestion
Ikke almindelig:
Abdominal pain, nausea, diarrhoea, dyspepsia Uncommon:
Konstipation, tandsmerter, tør mund, flatulens, gastritis, opkastning.
Constipation, dental pain, dry mouth, flatulence, gastritis, vomiting
Lever og galdeveje Ikke kendt:
Hepato-biliary disorders Not known:
Abnorm leverfunktion.
Liver function abnormalities