natgillin/translations-raw huggingface dataset:
Mere end 50 % af de patienter, der nåede målblodtrykket med fastdosiskombinationen inden for fire uger, havde ikke behov for en kombinationsbehandling.
More than 50% of those patients reaching the target BP on the FDC within 4 weeks did not require a combination.
Nyretransplantation Der er ingen erfaring med patienter, der for nylig er nyretransplanteret.
Renal transplantation There is no experience in patients with recent kidney transplantation.
Desuden hæmmer losartan ikke ACE (kininase II), enzymet som nedbryder bradykinin.
Furthermore, losartan does not inhibit ACE (kininase II), the enzyme that degrades bradykinin.
Forværring eller aktivering af systemisk lupus erythematosus er rapporteret i forbindelse med behandling med thiazider.
Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazides.
• hvis De har eller har haft en allergisk tilstand, astma eller en tilstand som kan medføre ledsmerter, hududslæt og feber (systemisk lupus erythematosus)
• if you have or have had an allergic condition, asthma or a condition that causes joint pain, skin rashes and fever (systemic lupus erythematodus).
Generelt gav losartan et fald i serumurinsyre (sædvanligvis <0,4 mg/dl), som var vedvarende ved kronisk terapi.
Generally losartan causes a decrease in serum uric acid (usually <0.4 mg/dL) which was persistent in chronic therapy.
Hvis lægen har fortalt Dem, at der er visse sukkerarter, De ikke kan tåle, skal De kontakte Deres læge, før De tager denne medicin.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Den mest sandsynlige manifestation ved overdosering vil være hypotension og takykardi; bradykardi kan opstå af parasympatisk (vagus) stimulation.
The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation.
Både losartan og dets primære aktive metabolit har meget større affinitet over for AT1-receptoren end over for AT2-receptoren.
Both losartan and its principal active metabolite have a far greater affinity for the AT1 receptor than for the AT2 receptor.
Det er vigtigt at fortsætte med at tage Cozaar Comp., så længe lægen foreskriver det, da det vil sikre en jævn kontrol af Deres blodtryk.
It is important to continue taking Cozaar Comp for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.
Derfor bør losartan/hydrochlorthiazid ikke administrers til børn og unge.
Therefore, losartan/hydrochlorothiazide should not be administered to children and adolescents.
Ca. 14% af en intravenøs eller oralt administreret dosis af losartan omdannes til dets aktive metabolit.
About 14% of an intravenously- or orally-administered dose of losartan is converted to its active metabolite.
Sjælden (berører mere end én person ud af 10.000 og færre end én person ud af 1.000): • Hepatitis (betændelse i leveren), unormale leverfunktionsprøver
Rare (more than 1 out of 10000 patients and less than 1 out of 1000 patients) • Hepatitis (inflammation of the liver), abnormal liver function tests
Ud over disse bivirkninger er der rapporteret om yderligere bivirkninger efter produktets introduktion på markedet.
Next to these effects, there are further adverse reactions reported after the introduction of the product to the market as follows:
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.viale Shakespeare 47 , 00144 Rom, Italien
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.- viale Shakespeare 47, 00144 Rome, Italy
• Nedsat seksuallyst, impotens
• Decreased sexual appetite, impotence,
Efter en oral dosis 14C-mærket losartan til mennesker, blev ca. 35% af radioaktiviteten genfundet i urin og 58% i fæces.
Following an oral dose of 14C-labeled losartan in man, about 35% of radioactivity is recovered in the urine and 58% in the feces.
Hvis De bliver gravid, mens De tager Cozaar Comp., skal De omgående kontakte lægen.
If you become pregnant while on Cozaar Comp, tell your doctor immediately.
Hvis plasmakoncentrationen følges i mindst 24 timer er plasmahalveringstiden set at variere mellem 5,6 og 14,8 timer.
When plasma levels have been followed for at least 24 hours, the plasma half-life has been observed to vary between 5.6 and 14.8 hours.
Når dette sammenlignes med, at kun 8,2 % af patienterne kan nå målblodtrykket noget hurtigere sammenlignet med en trinvis tilgang, er benefit/risk-forholdet negativt både for patienter med svær og for patienter med mild til moderat hypertension.
When compared to only 8.2% of patients that can reach target BP somewhat faster compared to a stepwise approach, the risk benefit ratio is negative both for patients with severe and for patients with mild to moderate hypertension.
Som det er tilfældet med al antihypertesniv behandling kan hypotension forekomme hos nogle patienter.
As with all antihypertensive therapy, symptomatic hypotension may occur in some patients.
Carbamazepin Risiko for symptomatisk hyponatriæmi.
Carbamazepine Risk of symptomatic hyponatremia.
De skal helst ikke drikke alkohol, når De tager disse tabletter; alkohol og Cozaar Comp. kan medføre gensidig øget virkning.
You are advised not to drink alcohol whilst taking these tablets: alcohol and Cozaar Comp tablets may increase each other's effects.
Selvom der ikke findes kontrollerede epidemiologiske data vedrørende risikoen ved angiotensin IIreceptorhæmmere (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.
Når losartan administreres oralt, udskilles ca. 4% af dosis uændret i urinen, og ca. 6% af dosis udskilles via urinen som aktiv metabolit.
When losartan is administered orally, about 4% of the dose is excreted unchanged in the urine, and about 6% of the dose is excreted in the urine as active metabolite.
Angiotensin-II, der er en potent vasokonstriktor, er det primære aktive hormon i renin-angiotensinsystemet og en betydningsfuld determinant for hypertensions patofysiologi.
Angiotensin II, a potent vasoconstrictor, is the primary active hormon of the renin-angiotensin system and an important determinant of the pathophysiology of hypertension.
Efterfølgende er der blevet sat spørgsmålstegn ved den gavnlige virkning af atenolol, hvad angår kardiovaskulær morbiditet og mortalitet.
Since then the beneficial effect of atenolol regarding CV morbidity and mortality has been questioned.
Komponenterne i Cozaar Comp. har vist sig at have additiv virkning på reduktionen af blodtrykket, således at blodtrykket reduceres mere end ved brug af komponenterne alene.
The components of Cozaar Comp have been shown to have an additive effect on blood pressure reduction, reducing blood pressure to a greater degree than either component alone.
I losartangruppen fik 44 % af patienterne hydrochlorthiazid, og i atenololgruppen lå tallet på 38 %.
In the losartan group 44% of the patients received HCTZ, in the atenolol group 38%.
LIFE (The Losartan Intervention For Endpoint Reduction In Hypertension) var en randomiseret, trippelblindet, aktiv kontrolleret undersøgelse foretaget hos 9193 hypertensive patienter i alderen 55-80 år med EKG-diagnosticeret hypertrofi af venstre ventrikel.
The Losartan Intervention For Endpoint reduction in hypertension (LIFE) study was a randomised, triple-blind, active-controlled study in 9193 hypertensive patients aged 55 to 80 years with ECGdocumented left ventricular hypertrophy.
Præparater, der indeholder lithium, bør ikke tages sammen med Cozaar Comp. uden lægens nøje overvågning.
Preparations containing lithium should not be taken with Cozaar Comp without close supervision by your doctor.
Dosisjustering af antidiabetika kan være nødvendig.
Dosage adjustment of the antidiabetic drug may be required.
CHMP var betænkelig ved, at der ikke var nogen beviser, som understøttede, at hvert enkelt af de to stoffer i Cozaar Comp (losartan og hydrochlorthiazid) giver et dokumenteret bidrag til den indikation, som søgtes godkendt, og som var påkrævet i henhold til vejledningen om produkter med fastdosiskombination.
The CHMP was concerned that there is no evidence that supports each of the two substances in Cozaar Comp (losartan and HCTZ) having a documented contribution to the claimed indication as required by the The NfG on fixed dose combination products.
In vitro og in vivo blokerer losartan og dennes farmakologisk aktive carboxylsyremetabolit E-3174 alle fysiologisk relevante virkninger af angiotensin-II, uafhængig af kilde eller syntesevej.
In vitro and in vivo losartan and its pharmacologically active carboxylic acid metabolite E-3174 block all physiologically relevant actions of angiotensin II, regardless of the source or route of its synthesis.
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 coadministered with angiotensin II receptor antagonists.
Forsøg at tage Cozaar Comp. dagligt som foreskrevet.
Try to take Cozaar Comp daily as prescribed.
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.
Losartan har vist sig at have en mild og forbigående urikosurisk effekt.
Losartan has been shown to have a mild and transient uricosuric effect.
Som ved anden medicin der påvirker natriumudskillelsen, kan lithiumudskillelsen reduceres.
As with other medicines which affect the excretion of sodium, lithium excretion may be reduced.
Lægen bestemmer, hvilken dosis af Cozaar Comp. der er hensigtsmæssig for Dem, afhængigt af Deres tilstand, og om De tager anden medicin.
Your doctor will decide on the appropriate dose of Cozaar Comp depending on your condition and whether you are taking other medicines.
Lad blisterpakningen blive i den ydre karton og hold beholderen tæt tillukket.
Keep the blister in the outer carton and the keep the bottle tightly closed.
Lindenplatz 1 85540, Haar Tyskland
Lindenplatz 1 85540, Haar Germany
Losartan bibeholder den glomerulære filtrationshastighed og reducerer filtrationsfraktionen.
Losartan maintains glomerular filtration rate and reduces filtration fraction.
Af denne grund finder ingen potensering af bradykininmedierede virkninger sted.
Consequently, there is thus no increase in bradykinin-mediated undesirable effects.
Afsnit 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen:
Section 4.4 Special warnings and precautions for use:
Øget dosering af probenecid og sulfinpyrazon kan være nødvendig.
Increase in dosage of probenecid or sulfinpyrazone may be necessary.
Cyclosporin
Cyclosporine
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.
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 nonblacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.
Metformin bør anvendes med forsigtighed på grund af risikoen for lactacidose, der induceres af muligt funktionelt nyresvigt, der er forbundet med hydrochlorthiazid.
Metformin should be used with caution because of the risk of lactic acidosis induced by possible functional renal failure linked to hydrochlorothiazide.
• hvis De har primær hyperaldosteronisme (et syndrom der er forbundet med øget udskillelse af hormonet aldosteron fra binyrerne, som skyldes en abnormitet i kirtlen).
• if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldesterone by the adrenal gland, caused by an abnormality within the gland).
Behandling med Cozaar Comp. bør ikke initieres under graviditet.
Cozaar Comp should not be initiated during pregnancy.
Ud over den aktive metabolit dannes inaktive metabolitter, herunder 2 hovedmetabolitter dannet ved hydroxylering af butylsidekæden og en metabolit af mindre betydning, en N-2-tetrazolglucuronid.
In addition to the active metabolite, inactive metabolites are formed, including two major metabolites formed by hydroxylation of the butyl side chain and a minor metabolite, an N-2 tetrazole glucuronide.
Der har været isolerede rapporter om hæmolytisk anæmi, som forekommer ved samtidig anvendelse af hydrochlorthiazid og methyldopa.
There have been isolated reports of haemolytic anaemia occurring with concomitant use of hydrochlorothiazide and methyldopa.
I tilfælde af høje doser af salicylater kan hydrochlorthiazid forstærke salicylaternes toksiske effekt på centralnervesystemet.
In case of high dosages of salicylates hydrochlorothiazide may enhance the toxic effect of the salicylates on the central nervous system.
Markant hyperkalcæmi kan være tegn på skjult hyperparathyroidisme.
Marked hypercalcemia may be evidence of hidden hyperparathyroidism.
Tyskland MSD Chibropharm GmbH Postfach 1202 D-85530 Haar, Tyskland
Germany MSD Chibropharm GmbH Postfach 1202 D-85530 Haar
Patienter med sjælden arvelig galactoseintolerance, Lapp-lactasemangel eller glucose/galactosemalabsorption bør ikke tage denne medicin (se pkt.
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).
Andre stoffer, der kan inducere hypotension, som tricykliske antidepressiva, antipsykotika, baclofen, amifostin: Samtidig anvendelse af disse lægemidler, der som hoved- eller sideeffekt sænker blodtrykket, kan øge risikoen for hypotension.
Other substances inducing hypotension like tricyclic antidepressants, antipsychotics, baclofene, amifostine: Concomitant use with these drugs that lower blood pressure, as main or side-effect, may increase the risk of hypotension.
I en samlet analyse af 16 dobbeltblindede kliniske undersøgelser med 4131 patienter, var incidensen af spontant rapporteret hoste hos patienter, der fik losartan den samme (3,1%) som hos de patienter, der fik placebo (2,6%) eller hydrochlorthiazid (4,1%), hvorimod incidensen med ACE-hæmmere var 8,8%).
In addition, in an overall analysis of 16 double-blind clinical trials in 4131 patients, the incidence of spontaneously reported cough in patients treated with losartan was similar (3.1%) to that of patients treated with placebo (2.6%) or hydrochlorothiazide (4.1%), whereas the incidence with ACE inhibitors was 8.8%.
Der var ikke tegn på teratogenicitet hos rotter eller kaniner, der havde fået behandling med losartan/hydrochlorthiazid-kombinationen.
There was no evidence of teratogenicity in rats or rabbits treated with the losartan/hydrochlorothiazide combination.
Cozaar Comp. kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Cozaar Comp tablets can cause side effects, although not everybody gets them.
Den antihypertensive virkning af Cozaar Comp. holder i 24 timer.
The antihypertensive effect of Cozaar Comp is sustained for a 24-hour period.
Korticosteroider, ACTH Øget elektrolytdepletering, især hypokalæmi.
Corticosteroids, ACTH Intensified electrolyte depletion, particularly hypokalemia.
Lad blisterpakningen blive i den ydre karton.
Keep the blister in the outer carton.
Cozaar Comp. anvendes til behandling af essentiel hypertension (forhøjet blodtryk).
Cozaar Comp is indicated for the treatment of essential hypertension (high blood pressure).
Cozaar Comp. kan administreres sammen med andre antihypertensiva.
Cozaar Comp may be administered with other antihypertensive agents.
• hvis De har diabetes
• if you are diabetic
LIFE-undersøgelsen
LIFE Study
Farmakoterapeutisk klassifikation: Kombination af angiotensin II-receptor(type AT1)-antagonist og thiaziddiuretikum, antihypertensivum, ATC-kode: C09DA01
Pharmacotherapeutic group: Combination containing an angiotensin II-receptor(type AT1)-antagonist and a thiazide diuretic, Antihypertensive, ATC code: C09DA01
Behandling med Cozaar Comp. bør seponeres, og patienten observeres nøje.
Therapy with Cozaar Comp should be discontinued and the patient observed closely.
Vigtig information om nogle af de øvrige indholdsstoffer i Cozaar Comp.
Important information about some of the ingredients of Cozaar Comp
Afsnit 4.3 Kontraindikationer
Section 4.3 Contra-indications
Der er ingen klinisk signifikant effekt på plasmakoncentrationsprofilen, når losartan gives sammen med et standardiseret måltid.
There was no clinically significant effect on the plasma concentration profile of losartan when the drug was administered with a standardized meal.
• hvis De har højt indhold af kalcium eller lavt indhold af kalium eller De er på en diæt med lavt kalium
• if you have high calcium or low potassium levels or you are on a low potassium diet
Der er ingen erfaring med brug af Cozaar Comp. til børn.
There is no experience with the use of Cozaar Comp in children.
Mens den foreslåede indikation for losartanmonoterapi derfor blev godkendt af et flertal på CHMPs plenarmøde og blev understøttet af følgende ordlyd: “risikoreduktion af slagtilfælde hos hypertensive patienter med venstresidig ventrikelhypertrofi dokumenteret ved EKG”, så gælder følgende betragtninger for fastdosiskombinationen:
Therefore, whilst the proposed indication for losartan monotherapy was considered approvable after a majority vote by the CHMP plenum and is supported with the following wording: “reduction of risk of stroke in hypertensive patients with left ventricular hypertrophy, documented by ECG”, the following considerations apply for the FDC:
Hertfordshire EN11 9BU Storbritannien
Hertfordshire, EN11 9BU United Kingdom
Føtal toksicitet hos rotter, som fremgik af en let stigning i overtallige ribben i F1-generationen, sås når hunrotter blev behandlet før og under gestationen.
Foetal toxicity in rats, as evidenced by a slight increase in supernumerary ribs in the F1 generation, was observed when females were treated prior to and throughout gestation.
• hvis De er overfølsom (allergisk) over for andre sulfonamidafledte stoffer (f.eks. andre thiazider,
• if you are allergic (hypersensitive) to other sulfonamide-derived substances (e. g. other thiazides,
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.
Når det er klinisk hensigtsmæssigt, kan det overvejes at skifte direkte fra monoterapi til den faste kombination hos patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret.
When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately controlled.
Frankrig Merck Sharp Dohme Chibret 3 av. Hoche
Merck Sharp Dohme Chibret 3 av. Hoche
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.
Almindelige (berører færre end én person ud af 10 men flere end én person ud af 100):
Common (affecting less than one person in 10 but more than one person in 100):
Der er rapporteret om tilfælde af thrombocytopeni hos nyfødte og føtal eller neonatal icterus efter behandling af moderen med thiazider.
Cases of thrombocytopenia in neonates and fetal or neonatal jaundice were reported after treating the mothers with thiazides.
Efter oral administration absorberes losartan godt og undergår firstpass metabolisme, hvorved der dannes en aktiv carboxylsyremetabolit og andre inaktive metabolitter.
Following oral administration, losartan is well absorbed and undergoes first-pass metabolism, forming an active carboxylic acid metabolite and other inactive metabolites.
Som det sås i undersøgelser med losartan alene, forekom føtale og neonatale bivirkninger, herunder nyretoksicitet og fosterdød, når gravide rotter blev behandlet med losartan/hydrochlorthiazidkombinationen sent i gestationen og/eller diegivningen.
As observed in studies with losartan alone, adverse foetal and neonatal effects, including renal toxicity and foetal death, occurred when pregnant rate were treated with the losartan/hydrochlorothiazide combination during late gestation and/or lactation.
Indehaveren af markedsføringstilladelsen blev anmodet om at fremlægge data vedrørende sikkerhed og virkning for disse patientundergrupper (Losartan, Atenolol, Losartan + hydrochlorthiazid, Atenolol + hydrochlorthiazid) for at få en større indsigt i hydrochlorthiazids bidrag til det samlede benefit/riskforhold.
The MAH was asked to provide data on safety and efficacy for these subgroups of patients (Losartan, Atenolol, Losartan + HCTZ, Atenolol + HCTZ) in order to gain more insight into the contribution of HCTZ to the overall benefit risk ratio.
Tag dog ikke dobbelt dosis hvis De har glemt at tage en tablet.
However, if you miss a dose, do not take an extra dose.
Efter oral administration falder losartans og dets aktive metabolits plasmakoncentration polyeksponentielt med en terminal halveringstid på henholdsvis ca. 2 timer og 6-9 timer.
Following oral administration, plasma concentrations of losartan and its active metabolite decline polyexponentially with a terminal half-life of about 2 hours and 6-9 hours, respectively.
Stigning i biotilgængelighed over for thiazidtypediuretika ved at nedsætte den gastrointestinale motilitet samt mavetømningshastigheden.
Increase of the bioavailability to thiazide-type diuretics by decreasing gastrointestinal motility and stomach emptying rate.
• hvis De har lavt indhold af kalium, lavt indhold af natrium eller højt indhold af kalcium, som ikke kan forbedres ved behandling
• if you have low potassium, low sodium or high calcium levels which cannot be corrected by treatment
Slovenien Merck Sharp & Dohme, inovativna zdravila d.o.o., Smartinska cesta 140, 1000 Ljubljana, Slovenien
Slovenia Merck Sharp & Dohme, inovativna zdravila d.o.o., Smartinska cesta 140, 1000 Ljubljana
• hvis De kaster/har kastet voldsomt op eller har/har haft kraftig diarré
• if you have or have had severe vomiting and/or diarrhoea
Behandling med thiazider bør seponeres, før der udføres tests af parathyroideafunktionen.
Thiazides should be discontinued before carrying out tests for parathyroid function.
Andre antihypertensiva, undtagen ACE-hæmmere, angiotensin II-antagonister eller betablokkere, blev tilføjet hvis dette var nødvendigt for at opnå det ønskede blodtryk.
Other antihypertensives, with the exception of ACE inhibitors, angiotensin II antagonists or beta-blockers were added if necessary to reach the goal blood pressure.
• hvis De har alvorligt nedsat leverfunktion
• if you have severely impaired liver function
Thiazider passerer placentabarrieren og findes i navlestrengsblodet.
Thiazides pass the placental barrier and are found in cord blood.
Det har været rapporteret, at rifampicin og fluconazol reducerede den aktive metabolits koncentration.
Rifampicin and fluconazole have been reported to reduce levels of active metabolite.
Alkohol, barbiturater, narkotiske stoffer eller antidepressiva Potensering af orthostatisk hypotension kan forekomme.
Alcohol, barbiturates, narcotics or antidepressants: Potentiation of orthostatic hypotension may occur.