FrancophonIA/ELRC3.0 huggingface dataset:
English: The magnitude of these effects is small and has minimal clinical importance.
Danish: Omfanget af disse virkninger er lille og har minimal klinisk betydning.
English: The inclusion of syncope in section 4.8 is also justified.
Danish: Medtagelsen af synkope under afsnit 4.8 er også berettiget.
English: Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.
Danish: Afhængig af, hvordan du reagerer på behandlingen, vil din læge måske foreslå en højere eller lavere dosis.
English: Also, the safety profile of the components could be considered well known.
Danish: Komponenternes sikkerhedsprofil kunne desuden betegnes som kendt.
English: Some side effects can be serious and need immediate medical attention:
Danish: Nogle bivirkninger kan være alvorlige og kræver omgående lægebehandling:
English: Other side effects include:
Danish: De øvrige bivirkninger omfatter:
English: There were significant divergences in the contraindications.
Danish: Der var store forskelle i kontraindikationerne.
English: • Swallow the tablet with a glass of water.
Danish: • Tag tabletten sammen med et glas vand.
English: This should be taken into account during dosetitration".
Danish: Der skal tages højde for dette under dosistitrering".
English: It may be necessary to change the dose, to take other precautions, or in some cases to stop taking one of the medicines.
Danish: Det kan være nødvendigt at ændre dosis, at tage andre forholdsregler eller i nogle tilfælde stoppe med den ene medicin.
English: Your doctor will tell you exactly how many tablets of Diovan Comp to take.
Danish: Din læge vil fortælle dig helt nøjagtigt, hvor mange Diovan Comp tabletter du skal tage.
English: Avoid taking alcohol until you have talked to your doctor.
Danish: Undgå at indtage alkohol indtil du har talt med din læge.
English: Diovan Comp should not be used in these patients.
Danish: Diovan Comp bør ikke anvendes til disse patienter.
English: 2 & 4, rue Lionel Terray 92500 RUEIL-MALMAISON, France
Danish: 2 & 4, rue Lionel Terray 92500 RUEIL-MALMAISON, Frankrig
English: Both of these substances help to control high blood pressure (hypertension).
Danish: Begge disse stoffer hjælper med at kontrollere forhøjet blodtryk (hypertension).
English: Sweden Novartis Sverige AB Box 1150
Danish: Novartis Sverige AB Box 1150
English: You should see your doctor immediately if you experience symptoms of angioedema, such as:
Danish: Du skal omgående kontakte din læge, hvis du får symptomer på angioødem, som f.eks.
English: If you forget to take a dose, take it as soon as you remember.
Danish: Hvis du har glemt at tage en dosis, så tag den så snart du kommer i tanker om det.
English: But according to the European hypertension treatment Guidelines (Mancia et al., Eur Heart J 2007;28(12):1462-536) it is no longer warranted.
Danish: Men ifølge de europæiske retningslinjer for behandling af hypertension ("the European hypertension treatment Guidelines", Mancia et al., Eur Heart J 2007; 28(12):1462-536) er dette ikke længere påkrævet.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF DIOVAN COMP AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF DIOVAN COMP OG TILKNYTTEDE NAVNE (SE BILAG I)
English: Section 4.1 - Therapeutic Indications (See Annex III for the agreed therapeutic indications)
Danish: Afsnit 4.1 - Terapeutiske indikationer (se bilag III for de godkendte terapeutiske indikationer)
English: Absolute bioavailability of hydrochlorothiazide is 60-80% after oral administration.
Danish: Hydrochlorthiazids absolutte biotilgængelighed er 60-80 % efter oral administration.
English: • Do not change the dose or stop taking the tablets without consulting your doctor.
Danish: • Du må ikke ændre denne dosis eller holde op med at tage tabletterne uden at tale med din læge.
English: Therefore, monitoring of renal function at the beginning of the treatment is recommended, as well as adequate hydration of the patient.
Danish: Det anbefales derfor at monitorere nyrefunktionen i begyndelsen af behandlingen, ligesom tilstrækkelig hydrering af patienten anbefales.
English: Thrombocytopenia sometimes with purpura
Danish: Trombocytopeni, undertiden med purpura
English: • Do not use Diovan Comp after the expiry date which is stated on the pack.
Danish: • Brug ikke Diovan Comp efter den udløbsdato, der står på pakningen.
English: The increase in mean AUC is linear and dose proportional in the therapeutic range.
Danish: Øgningen i middel-AUC er lineær og dosisproportional i det terapeutiske område.
English: This makes it all the more important for you to keep your appointments with your doctor even if you are feeling well.
Danish: Det er derfor vigtigt, at du overholder dine lægebesøg, selvom du føler dig rask.
English: If a readministration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.
Danish: Hvis readministration af diuretika skønnes nødvendig, anbefales det at beskytte eksponerede områder mod sol og kunstig UVA.
English: The terminal half-life is 6-15 h.
Danish: Den terminale halveringstid er 6-15 t.
English: Calcium salts and vitamin D
Danish: Calciumsalte og D-vitamin
English: • if you suffer from hyperaldosteronism.
Danish: • hvis du lider af hyperaldosteronisme.
English: This will help you to get the best results and lower the risk of side effects.
Danish: Det vil hjælpe dig til at opnå den bedste behandling og mindske risikoen for bivirkninger.
English: DK-2100 Kopenhagen Ø
Danish: DK-2100 København Ø
English: In conclusion, the CHMP recommended, in line with the recently finalized referral procedure for Cozaar Comp, that “angiotensin-II-antagonist” is changed to “valsartan” in this indication.
Danish: Afslutningsvis anbefalede CHMP i overensstemmelse med den nyligt afsluttede indbringelsesprocedure for Cozaar Comp, at "angiotensin II-antagonist" ændres til "valsartan" i denne indikation.
English: Norway Novartis Norge AS Postboks 237 Økern 0510 Oslo
Danish: Novartis Norge AS Postboks 237 Økern 0510 Oslo
English: • blistering of the lips, eyes or mouth
Danish: • blærer på læber, øjne eller mund
English: Hydrochlorothiazide also accumulates in erythrocytes at approximately 1.8 times the level in plasma.
Danish: Hydrochlorthiazid akkumuleres også i erytrocytter, hvor niveauet af det er ca. 1,8 gange højere end i plasma.
English: Also, a paragraph regarding interaction with tetracycline has been deleted.
Danish: Desuden er der blevet slettet et punkt om interaktion med tetracyclin.
English: Based on the QRD comments on the Diovan and on the class labelling text regarding the use of AIIRAs during pregnancy the section 4.6 was implemented.
Danish: Baseret på QRD-kommentarerne om Diovan og på den klassificerende tekst om brugen af AIIRA under graviditet blev afsnit 4.6 implementeret.
English: The use of Diovan Comp in children and adolescents (below the age of 18 years) is not recommended.
Danish: Anvendelse af Diovan Comp til børn og unge (under 18 år) frarådes.
English: Your doctor may need to check the amount of potassium in your blood regularly.
Danish: Din læge kan være nødt til at måle indholdet af kalium i dit blod regelmæssigt.
English: Such patients should therefore be advised about the possibility of hyponatraemic reactions, and should be monitored accordingly.
Danish: Sådanne patienter skal derfor oplyses om risikoen for hyponatriæmiske reaktioner og skal monitoreres for disse.
English: Elderly No dose adjustment is required in elderly patients.
Danish: Ældre Der kræves ingen dosisjustering hos ældre patienter.
English: “Treatment of essential hypertension in adults”
Danish: "Behandling af essentiel hypertension hos voksne"
English: Other hypersensitivity/allergic reactions including serum sickness
Danish: Andre overfølsomheds-/allergiske reaktioner, herunder serumsyge
English: Alcohol may make your blood pressure fall more and/or increase the risk of you becoming dizzy or feeling faint.
Danish: Alkohol kan få dit blodtryk til at falde mere og/eller øge risikoen for, at du bliver svimmel eller føler, at du er ved at besvime.
English: Dose titration with the individual components is recommended.
Danish: Dosistitrering med de individuelle komponenter anbefales.
English: A specific warning for athletes was to be deleted as the CHMP considered that drugs should not be taken for sport purposes.
Danish: En specifik advarsel henvendt til sportsudøvere skulle slettes, da CHMP's holdning var, at lægemidler ikke bør indtages med sportspræstationer for øje.
English: This may result in hypercalcaemia.
Danish: Dette kan medføre hyperkalcæmi.
English: • fever (cutaneous lupus erythematosus)
Danish: • feber (kutan lupus erythematosus)
English: Treatment of essential hypertension in adults.
Danish: Behandling af essentiel hypertension hos voksne.
English: Patients with primary hyperaldosteronism should not be treated with Diovan Comp as their reninangiotensin system is not activated.
Danish: Patienter med primær hyperaldosteronisme bør ikke behandles med Diovan Comp, da deres reninangiotensin-system ikke er aktiveret.
English: • if the level of potassium or sodium in your blood is lower than normal, or if the level of calcium in your blood is higher than normal despite treatment.
Danish: • hvis mængden af kalium eller natrium i dit blod er lavere end normalt, eller hvis mængden af calcium i dit blod er højere end normalt på trods af behandling.
English: • skin rash with or without itching together with some of the following signs or symptoms: fever,
Danish: • udslæt med eller uden kløe sammen med nogle af de følgende tegn eller symptomer: feber,
English: Diovan Comp is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy.
Danish: Diovan Comp bør ikke anvendes til børn under 18 år pga. manglende dokumentation for sikkerhed og virkning.
English: The purpose of the study was to determine the optimal dose of valsartan for reducing UAE in hypertensive patients with type 2 diabetes.
Danish: Formålet med undersøgelsen var at bestemme den optimale valsartandosis til reduktion af UAE hos hypertensive patienter med type 2 diabetes.
English: Medicinal products that could induce torsades de pointes
Danish: Lægemidler som kan fremkalde torsades de pointes
English: The effect of the treatment can be influenced if Diovan Comp is taken together with certain other medicines.
Danish: Virkningen af behandlingen kan blive påvirket, hvis du tager Diovan Comp sammen med visse andre typer medicin.
English: • if you have recently received a new kidney.
Danish: • hvis du for nylig har fået en ny nyre.
English: If photosensitivity reaction occurs during treatment, it is recommended to stop the treatment.
Danish: Hvis der opstår lysfølsomhedsreaktioner under behandlingen, anbefales det at seponere behandlingen.
English: Always take Diovan Comp exactly as your doctor has told you.
Danish: Tag altid Diovan Comp nøjagtigt efter lægens anvisning.
English: • The usual dose of Diovan Comp is one tablet per day.
Danish: • Den sædvanlige dosis Diovan Comp er én tablet daglig.
English: However, in some patients 4-8 weeks treatment may be required.
Danish: Dog kan 4-8 ugers behandling være nødvendig hos nogle patienter.
English: However, in some patients, 4-8 weeks treatment may be required.
Danish: Men hos nogle patienter kan fire til otte ugers behandling være nødvendig.
English: Hungary Novartis Hungaria Kft. Bartók Béla út 43-47
Danish: Ungarn Novartis Hungaria Kft. Bartók Béla út 43-47
English: Section 4.2 - Posology and Method of Administration Under this section the CHMP identified several area of disagreement.
Danish: Afsnit 4.2 - Dosering og indgivelsesmåde I dette afsnit identificerede CHMP flere områder, hvor der findes uoverensstemmelser.
English: • Do not use any Diovan Comp pack that is damaged or shows signs of tampering.
Danish: • Brug ikke pakninger af Diovan Comp, der er beskadiget eller viser tegn på at have være åbnet.
English: Like all medicines, Diovan Comp can cause side effects, although not everybody gets them.
Danish: Diovan Comp kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: There is no change in the kinetics of hydrochlorothiazide on repeated dosing, and accumulation is minimal when dosed once daily.
Danish: Der er ingen ændring i kinetikken for hydrochlorthiazid ved gentagen dosering, og akkumuleringen er minimal ved dosering én gang dagligt.
English: Regarding the use of Diovan Comp during pregnancy and lactation, the CHMP decided to delete lactation as a contraindication in the revised SPC.
Danish: Når det gælder brugen af Diovan Comp under graviditet og amning, besluttede CHMP at slette amning som en kontraindikation i det reviderede produktresumé.
English: No findings emerged that would exclude the use of therapeutic doses in man.
Danish: Der fremkom ingen fund, der ville udelukke brugen af den terapeutiske dosis hos mennesker.
English: Clinical data, however, demonstrate that the antihypertensive effect of all doses of valsartan/HCTZ is substantially present within 2 weeks, and maximal effects are attained within 4 weeks.
Danish: Kliniske data viser dog, at den antihypertensive effekt af alle doser af valsartan/HCTZ kunne påvises inden for to uger, og den maksimale effekt opnås inden for fire uger.
English: • swelling and blistering of the skin (due to increased sensitivity to sun)
Danish: • hævelser og blæredannelse i huden (pga. øget følsomhed over for sol)
English: Due to the lack of experience with concomitant use of valsartan and lithium, this combination is not recommended.
Danish: På grund af den manglende erfaring med samtidig brug af valsartan og lithium kan kombinationen ikke anbefales.
English: In most patients, maximal effects are observed within 4 weeks.
Danish: Hos de fleste patienter ses den maksimale effekt inden for fire uger.
English: There is currently no experience on the safe use of Diovan Comp in patients who have recently undergone kidney transplantation.
Danish: Der er på nuværende tidspunkt ingen erfaring med sikkerheden ved brug af Diovan Comp til patienter, som for nyligt er blevet nyretransplanteret.
English: • if you are taking high doses of water tablets (diuretics).
Danish: • hvis du tager høje doser af vanddrivende medicin (diuretika).
English: • ciclosporin, a medicine used for organ transplant to avoid organ rejection
Danish: • ciclosporin, medicin, der bruges ved organtransplantation for at undgå afstødning
English: • amantadine (a medicine used to prevent influenza)
Danish: • amantadin (medicin, der bruges til forebyggelse af influenza)
English: The following contra-indications were not included in all Member States: - Hepatic encephalopathy - Biliary obstruction - Gout -Addison's disease
Danish: Følgende kontraindikationer var ikke medtaget i alle medlemsstater: - Leverencefalopati - Biliær obstruktion - Urinsyregigt - Addisons sygdom
English: A harmonised wording regarding pregnancy across the Angiotensin II Receptor Antagonists (AIIRA) class was introduced in October 2007 (Recommendations from EMEA Pharmacovigilance Working Party regarding the use of ACE inhibitors & AIIRAs in pregnancy).
Danish: En harmoniseret formulering om graviditet for hele klassen af angiotensin II-receptorantagonister (AIIRA) blev indført i oktober 2007 (anbefalinger fra EMEA's arbejdsgruppe vedrørende lægemiddelovervågning i forbindelse med brug af ACE-hæmmere og AIIRA under graviditet).
English: The antihypertensive effect persists over 24 hours after dosing.
Danish: Den antihypertensive effekt varer i 24 timer efter dosering.
English: • sad mood (depression)
Danish: • tristhed (depression)
English: Sodium and/or volume depletion should be corrected before starting treatment with Diovan Comp.
Danish: Natrium- og/eller væskemangel bør korrigeres før behandling med Diovan Comp initieres.
English: Diovan Comp is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Danish: Diovan Comp frarådes i den tidlige perioden af graviditeten og må ikke tages, hvis du er mere end 3 måneder henne i graviditeten, da det kan medføre alvorlige skader på dit barn, hvis det bruges på dette tidspunkt (se afsnittet om graviditet).
English: Although hydrochlorthiazide is excreted into human milk, this does not warrant a contraindication.
Danish: Selv om hydrochlorothiazid udskilles i modermælk hos mennesker, berettiger dette ikke en kontraindikation.
English: Valsartan is primarily eliminated in faeces (about 83% of dose) and urine (about 13% of dose), mainly as unchanged drug.
Danish: Valsartan udskilles primært i fæces (cirka 83 % af dosis) og i urin (cirka 13 % af dosis), hovedsageligt som uomdannet stof.
English: There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester.
Danish: Erfaringerne med hydrochlorthiazid under graviditet, særlig i første trimester, er begrænsede.
English: This should be taken into account during dose titration.
Danish: Dette bør tages i betragtning under dosistitrering.
English: The treatment with a thiazide may influence the glucose tolerance.
Danish: Behandling med et thiazid kan påvirke glucosetolerancen.
English: For hydrochlorotiazide, >95% of the absorbed dose being excreted as unchanged compound in the urine.
Danish: For hydrochlorthiazids vedkommende udskilles >95 % af den absorberede dosis uændret i urinen.
English: Caution should be exercised in patients who have shown prior hypersensitivity to other angiotensin II receptor antagonists.
Danish: Der skal udvises forsigtighed hos patienter, der tidligere har vist overfølsomhed over for andre angiotensin II-antagonister.
English: • if you are unable to urinate.
Danish: • hvis du ikke er i stand til at lade vandet.
English: • severe upper stomach pain; lack or low levels of different blood cells
Danish: • kraftige smerter øverst i maven, mangel på eller lavt niveau af forskellige blodceller
English: Thiazides should be discontinued before carrying out tests for parathyroid function.
Danish: Thiazider bør seponeres før udførelse af test for paratyroid funktion.
English: • faintness, fainting on standing up
Danish: • svimmelhed, besvimelse, når man rejser sig op
English: • Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as “water tablets”).
Danish: • Hydrochlorthiazid tilhører en gruppe medicin, der kaldes thiaziddiuretika (også kendt som vanddrivende medicin).
English: Since there is no effect on ACE and no potentiation of bradykinin or substance P, angiotensin II antagonists are unlikely to be associated with coughing.
Danish: Da der ikke er nogen virkning på ACE og ingen potensering af bradykinin eller substans P, er det usandsynligt, at behandling med angiotensin II-antagonister vil være forbundet med hoste.
English: The systemic availability of hydrochlorothiazide is reduced by about 30% when co-administered with valsartan.
Danish: Den systemiske tilgængelighed af hydrochlorthiazid nedsættes med omkring 30 %, når det administreres samtidig med valsartan.
English: This observed interaction has no impact on the combined use of valsartan and hydrochlorothiazide, since controlled clinical trials have shown a clear anti-hypertensive effect, greater than that obtained with either active substance given alone, or placebo.
Danish: Denne observerede interaktion har ingen effekt på brug af kombinationen valsartan og hydrochlorthiazid, da kontrollerede forsøg har vist en tydelig antihypertensiv virkning, som er større end den, der ses, når et af de aktive stoffer gives alene, eller ved placebo.
English: In conclusion, the CHMP agreed the following: "The antihypertensive effect is substantially present within 2 weeks.
Danish: CHMP vedtog således følgende indikation: "Den antihypertensive effekt kan påvises inden for to uger.
English: The CHMP recommended to insert “photosensitivity with hydrochlorothiazide” under this section with a cross reference to section 4.8 and a specific warning for the investigation of parathyroid function.
Danish: CHMP anbefalede at tilføje "lysfølsomhed i forbindelse med hydrochlorothiazid" under dette afsnit med en krydshenvisning til afsnit 4.8 og en specifik advarsel om at overvåge skjoldbruskkirtelfunktionen.
English: The MAH justified the choice of not including information on the involvement of transporter proteins in section 4.5 of Diovan Comp SPC, in line with the outcome of the Diovan referral.
Danish: Indehaveren af markedsføringstilladelsen begrundede beslutningen om ikke at medtage oplysningerne om transportproteiner under afsnit 4.5 i produktresuméet for Diovan Comp, hvilket stemmer overens med resultatet af indbringelsesproceduren for Diovan.
English: Epidemiological studies have shown that long-term treatment with hydrochlorothiazide reduces the risk of cardiovascular mortality and morbidity.
Danish: Epidemiologiske studier har vist, at langvarig behandling med hydrochlorthiazid nedsætter risikoen for kardiovaskulær mortalitet og morbiditet.
English: Alcohol, anaesthetics and sedatives Potentiation of orthostatic hypotension may occur.
Danish: Alkohol, anæstetika og sedativa Potentiering af ortostatisk hypotension kan forekomme.
English: Novartis (Hellas) S.A.C.I.
Danish: Grækenland Novartis (Hellas) S.A.C.I.
English: • You can take Diovan Comp with or without food.
Danish: • Du kan tage Diovan Comp med eller uden mad.
English: Patients were randomised to one of 3 doses of valsartan (160, 320 and 640 mg/od) and treated for 30 weeks.
Danish: Patienterne blev randomiseret til en af 3 valsartandoser (160, 320 eller 640 mg 1 gang daglig) og blev behandlet i 30 uger.
English: Additional information on the individual components Adverse reactions previously reported with one of the individual components may be potential undesirable effects with Diovan Comp as well, even if not observed in clinical trials or during postmarketing period.
Danish: Yderligere oplysninger om de individuelle komponenter Bivirkninger, der tidligere er rapporteret med en af de enkelte komponenter, kan være potentielle bivirkninger ved Diovan Comp, også selvom de ikke er set i kliniske forsøg eller i perioden efter markedsføring.
English: It acts selectively on the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
Danish: Det virker selektivt på AT1receptor-subtypen, som er ansvarlig for angiotensin II's kendte virkninger.
English: The CHMP agreed that a greater reduction in both systolic and diastolic BP were seen in the non-responder studies for all strengths from week 4 to week 8 compared to the factorial studies.
Danish: CHMP konstaterede, at der blev observeret et større fald i både det systoliske og det diastoliske blodtryk i undersøgelserne med ikkeresponderende patienter ved alle styrker fra uge 4 til uge 8 sammenlignet med de faktorielle undersøgelser.
English: The CHMP, in the interest of readability, revised this section and agreed on including information about the thiazide.
Danish: For læsbarhedens skyld reviderede CHMP dette afsnit og besluttede at tilføje oplysninger om thiazid.
English: These contraindications were deleted in the revised PI as the CHMP found enough justifications and agreed about the four exclusion.
Danish: Disse kontraindikationer blev slettet i den reviderede produktinformation, da CHMP fandt tilstrækkeligt med begrundelser og derfor besluttede denne udelukkelse.
English: • itching or red skin
Danish: • kløende eller rød hud
English: • lithium, a medicine used to treat some types of psychiatric illness
Danish: • lithium, medicin, som anvendes til at behandle visse typer psykiske lidelser
English: Necrotising vasculitis and toxic epidermal necrolysis, cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus
Danish: Nekrotiserende vasculitis og toksisk epidermal nekrolyse, kutane lupus erythematosus-lignende reaktioner, reaktivering af kutan lupus erythematosus
English: These findings appear to have no relevance to the use of therapeutic doses of valsartan in humans.
Danish: Disse fund synes ikke at være relevante for anvendelsen af terapeutiske doser valsartan til mennesker.