FrancophonIA/ELRC3.0 huggingface dataset:
English: As in adults, Diovan is contraindicated in paediatric patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis (see sections 4.3 and 5.2).
Danish: Som hos voksne er Diovan kontraindiceret hos pædiatriske patienter med svært nedsat leverfunktion, biliær cirrhose og hos patienter med chiolestasis (se pkt.
English: • decreased kidney function (signs of renal impairment)
Danish: • nedsat nyrefunktion (tegn på nyreinsufficiens)
English: Increase of serum potassium
Danish: Øget serum-kalium
English: • if you are suffering from a narrowing of the kidney artery.
Danish: • hvis du lider af forsnævring af blodtilførslen til nyrerne.
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN [Se Bilag I - Udfyldes nationalt]
English: In a clinical trial of patients with a history of dry cough during ACE inhibitor therapy, 19.5% of trial subjects receiving valsartan and 19.0% of those receiving a thiazide diuretic experienced cough compared to 68.5% of those treated with an ACE inhibitor (p<0.05).
Danish: I en klinisk undersøgelse med patienter, som tidligere havde haft tør hoste under behandling med en ACE-hæmmer, konstateredes tør hoste hos 19,5 % af patienterne i valsartanbehandling, 19,0 % i thiazidbehandling, sammenholdt med 68,5 % i behandling med en ACE-hæmmer (P < 0,05).
English: These effects above mentioned represent an expected exaggerated pharmacological effect of angiotensin converting enzyme inhibitors and angiotensin II type 1 blockers; such effects are observed if rats are treated during the first 13 days of life.
Danish: Disse her omtalte virkninger repræsenterer en forventet overdreven farmakologisk effekt af ACE-hæmmere og angiotensin-II type I-blokkere.
English: • Diovan solution contains 0.3 g sucrose per millilitre.
Danish: • Diovan oral opløsning indeholder 0,3 g saccharose per milliliter.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml contains 3 mg of valsartan.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver ml indeholder 3 mg valsartan
English: Citric acid, anhydrous Sodium citrate
Danish: Citronsyre, vandfri Natriumcitrat
English: Renal and urinary disorders Not known
Danish: Nyrer og urinveje Ikke kendt
English: Clinical experience in children at or above 6 years of age In a clinical study involving 261 hypertensive paediatric patients 6 to 16 years of age, patients who weighed <35 kg received 10, 40 or 80 mg of valsartan tablets daily (low, medium and high doses), and patients who weighed 35 kg received 20, 80, and 160 mg of valsartan tablets daily (low, medium and high doses).
Danish: I et klinisk forsøg med 261, der inkluderede hypertensive pædiatriske patienter i alderen 6 til 16 år, fik patienter, som vejede <35 kg 10, 40 eller 80 mg valsartantabletter dagligt (lav, middel og høj dosis), og patienter, som vejede 35 kg fik 20, 80 eller 160 mg valsartantabletter dagligt (lav, middel og høj dosis).
English: • Do not store above 30°C.
Danish: • Må ikke opbevares ved temperaturer over 30 °C.
English: The dose should be adjusted based on blood pressure response up to a maximum dose of 80 mg valsartan (corresponding to 27 ml of the solution).
Danish: Dosis bør justeres til en maksimal dosis på 80 mg valsartan (svarende til 27 ml oral opløsning) i henhold til virkningen på blodtrykket.
English: • Diovan solution contains methyl parahydroxybenzoate (E218).
Danish: • Diovan oral opløsning indeholder methylparahydroxybenzoat (E218).
English: Dose adjustment is therefore not required in patients with renal impairment (creatinine clearance >10 ml/min).
Danish: Dosisjustering er derfor ikke påkrævet for patienter med nedsat nyrefunktion (kreatinin-clearance >10 ml/min).
English: For dosing recommendations in this case, see section 4.2.
Danish: For dosisanbefalinger i sådanne tilfælde, se pkt.
English: The increased plasma levels of Ang II following AT1 receptor blockade with valsartan may stimulate the unblocked AT2 receptor, which appears to counterbalance the effect of the AT1 receptor.
Danish: Dette kan stimulere den ublokerede AT2-receptor subtype, som tilsyneladende modvirker effekten af AT1-receptoren.
English: Valsartan is unlikely to be removed by haemodialysis.
Danish: Det er usandsynligt at Valsartan fjernes ved hæmodialyse.
English: Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other agents that may increase potassium levels (heparin, etc.) is not recommended.
Danish: Samtidig brug af kaliumtilskud, kaliumbesparende diuretika, salterstatninger indeholdende kalium eller andre produkter, som kan øge kaliumniveauet (heparin o.
English: • The other ingredients are sucrose, methyl parahydroxybenzoate (E218), potassium sorbate,
Danish: • Øvrige indholdsstoffer: saccharose, methylparahydroxybenzoat (E218), kaliumsorbat,
English: Ear and labyrinth system disorders Uncommon
Danish: Øre og labyrint Ikke almindelig
English: Patients were randomized to one of 3 doses of valsartan (160, 320 and 640 mg/od) and treated for 30 weeks.
Danish: (160, 320 og 640 mg/od) og behandledes i 30 uger.
English: 1 bottle containing 160 ml oral solution.
Danish: Pakningsstørrelse: 1 flaske med 160 ml oral opløsning.
English: These doses in rats (600 mg/kg/day) are approximately 18 times the maximum recommended human dose on a mg/m2 basis (calculations assume an oral dose of
Danish: Disse doser hos rotter (600 mg/kg/dag) er cirka 18 gange højere end den anbefalede humane maksimumdosis, udregnet ifølge mg/m2 (beregningerne går ud fra en oral dosis på 320 mg/dag til en patient, der vejer 60 kg).
English: Volume to take
Danish: Volumen
English: Use in paediatric patients aged 6 to 18 years with hepatic impairment As in adults, Diovan is contraindicated in paediatric patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis (see sections 4.3, 4.4 and 5.2).
Danish: Brug hos patienter i aldersgruppen 6 til 18 år med nedsat leverfunktion Som hos voksne er Diovan kontraindiceret hos pædiatriske patienter med svært nedsat leverfunktion, biliær cirrhose og hos patienter med cholestasis (se pkt.
English: Renal and urinary disorders Common
Danish: Nyrer og urinveje Almindelig
English: Vascular disorders Not known
Danish: Vaskulære sygdomme Ikke kendt
English: Children weighing between 18 kg and <35 kg received valsartan 80 mg or enalapril 10 mg; those between 35 kg and <80 kg received valsartan 160 mg or enalapril 20 mg; those 80 kg received valsartan 320 mg or enalapril 40 mg.
Danish: Børn, der vejede mellem 18 kg og <35 kg fik valsartan 80 mg eller enalapril 10 mg.
English: INSTRUCTIONS ON USE [To be completed nationally] 16.
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN [Udfyldes nationalt]
English: • Diovan solution contains poloxamer (188).
Danish: • Diovan oral opløsning indeholder poloxamer (188).
English: Methyl parahydroxybenzoate (E218) Potassium sorbate
Danish: Methylparahydroxybenzoat (E218) Kaliumsorbat
English: poloxamer (188), citric acid anhydrous, sodium citrate, artificial blueberry flavour, propylene glycol (E1520), sodium hydroxide, hydrochloric acid, purified water.
Danish: poloxamer (188), vandfri citronsyre, natriumcitrat, kunstig blåbærsmag, propylenglycol
English: Holding the oral syringe in place, carefully turn the bottle and oral syringe upside down.
Danish: Hold den orale sprøjte på plads og vend forsigtigt flasken og den orale sprøjte på hovedet.
English: There is currently no experience on the safe use in patients with a creatinine clearance <10 ml/min and patients undergoing dialysis, therefore valsartan should be used with caution in these patients (see sections 4.2 and 4.4).
Danish: Der findes ingen erfaring mht. sikker brug hos patienter med en kreatinin-clearance < 10 ml/min og patienter i dialysebehandling, derfor bør valsartan anvendes med forsigtighed til disse patienter (se pkt.
English: Take special care with Diovan:
Danish: Vær ekstra forsigtig med at tage Diovan
English: 180 ml amber type III glass bottle with a white child resistant polypropylene cap, including a polyethylene sealing disk and a yellow tamper evident ring, in addition the pack includes one dispensing kit containing one 5 ml oral dosing polypropylene syringe, one press in bottle adapter and one 30 ml polypropylene dosing cup.
Danish: 180 ml ravgul, type III glasflaske med et hvidt, børnesikret polypropylenlåg, inklusive en polyethylenforseglingsskive og en gul sikkerhedsring.
English: NAME OF THE MEDICINAL PRODUCT Diovan and associated names 3 mg/ml oral solution
Danish: LÆGEMIDLETS NAVN Diovan og tilhørende navne 3 mg/ml oral opløsning
English: Renal failure and impairment
Danish: Nyresvigt og nyreinsufficiens
English: It comes with a dispensing kit containing one press in bottle adapter, one 5 ml oral polypropylene dosing syringe and one 30 ml polypropylene dosing cup.
Danish: Der er vedlagt doseringsudstyr bestående af doseringsadapter, en 5 ml oral polypropylen-doseringssprøjte og en 30 ml polypropylen-doseringskop.
English: In a study of 26 paediatric hypertensive patients (aged 1 to 16 years) given a single dose of a suspension of valsartan (mean: 0.9 to 2 mg/kg, with a maximum dose of 80 mg), the clearance (litres/h/kg) of valsartan was comparable across the age range of 1 to 16 years and similar to that of adults receiving the same formulation.
Danish: 0,9 til 2 mg/kg med en maksimal dosis på 80 mg) var clearance (liter/time/kg) af valsartan ensartet på tværs af aldersgruppe fra 1 til 16 år og lignende til det for voksne, som fik samme formulering.
English: Use in paediatric patients aged 6 to 18 years with renal impairment Use in paediatric patients with a creatinine clearance <30 ml/min and paediatric patients undergoing dialysis has not been studied, therefore valsartan is not recommended in these patients.
Danish: Brug hos pædiatriske patienter i aldersgruppen 6 til 18 år med nedsat nyrefunktion Brug til pædiatriske patienter med en kreatininclearence <30 ml/min og til pædiatriske patienter i dialyse er ikke undersøgt.
English: Diovan and associated names 3 mg/ml oral solution Valsartan
Danish: Diovan og tilhørende navne 3 mg/ml oral opløsning Valsartan
English: In severely sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur in rare cases after initiation of therapy with Diovan.
Danish: Symptomatisk hypotension kan i sjældne tilfælde opstå efter påbegyndt behandling med Diovan hos patienter med alvorlig natrium- og/eller væskemangel, såsom de, der får høje doser af diuretika.
English: Holding the open bottle upright on a table, push the bottle adapter firmly into the neck of the bottle as far as it will go.
Danish: Tryk flaskeadapteren fast ned i flaskehalsen, så langt, som den kan komme.
English: o In the pharmacovigilance plan: Targeted checklists for follow up of adverse events listed above as potential risks in the paediatric population A study primarily aimed at establishing the long-term safety in CKD and non-CKD paediatric patients.
Danish: Målrettede tjeklister for opfølgning på de utilsigtede hændelser, der er nævnt ovenfor som potentielle risici hos den pædiatriske population.
English: Replace the child-resistant screw cap after use.
Danish: Sæt det børnesikrede skruelåg på efter brug.
English: Food decreases exposure (as measured by AUC) to valsartan by about 40% and peak plasma concentration (Cmax) by about 50%, although from about 8 h post dosing plasma valsartan concentrations are similar for the fed and fasted groups.
Danish: (Cmax) med cirka 50 %, selv om valsartankoncentrationen i plasma fra cirka 8 timer efter doseringen er ens for gruppen med føde og en fastende gruppe.
English: In hypertension in children and adolescents, where underlying renal abnormalities are common, caution is recommended with the concomitant use of valsartan and other substances that inhibit the renin angiotensin aldosterone system which may increase serum potassium.
Danish: Det anbefales at være forsigtig med samtidig brug af valsartan og andre stoffer, der hæmmer reninangiotensin-aldosteron-systemet, som kan øge serumkalium hos børn og unge med hypertension, hvor en underliggende uregelmæssig nyrefunktion er almindelig.
English: Do not take Diovan:
Danish: Tag ikke Diovan
English: How to take Diovan
Danish: SÅDAN SKAL DU TAGE DIOVAN
English: However, other agents that affect the renin-angiotensin system may increase blood urea and serum creatinine in patients with unilateral renal artery stenosis, therefore monitoring of renal function is recommended when patients are treated with valsartan.
Danish: Imidlertid anbefales monitorering af nyrefunktionen, når patienter behandles med valsartan, fordi andre stoffer, som påvirker renin-angiotensin-systemet, kan øge blodurinstof og serum-kreatinin hos patienter med unilateral nyrearteristenose.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Diovan solution.
Danish: Kontakt lægen, før du tager Diovan opløsning, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: 1 dispenser kit containing one press in bottle adapter, one 5 ml oral syringe and one 30 ml dosing cup.
Danish: 1 doseringsudstyr med en doseringsadapter, en 5 ml oral doseringssprøjte og en 30 ml doseringskop.
English: NAME OF THE MEDICINAL PRODUCT Diovan and associated names 3 mg/ml oral solution Valsartan
Danish: LÆGEMIDLETS NAVN Diovan og tilhørende navne 3 mg/ml oral opløsning Valsartan
English: Pack size: 1 bottle containing 160 ml oral solution
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 1 flaske indeholder 160 ml oral opløsning.
English: Use in paediatric patients with a creatinine clearance <30 ml/min and paediatric patients undergoing dialysis has not been studied, therefore valsartan is not recommended in these patients.
Danish: Brug til pædiatriske patienter med en kreatininclearance <30 ml/min og til pædiatriske patienter i dialyse er ikke undersøgt.
English: • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Danish: • Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: Diovan has not been studied in patients with severe hepatic dysfunction (see sections 4.2, 4.3 and 4.4).
Danish: Diovan er ikke undersøgt hos patienter med alvorlig leverinsufficiens (se pkt.
English: No dose adjustment is required for paediatric patients with a creatinine clearance >30 ml/min.
Danish: Dosisjustering til pædiatriske patienter med en kreatininclearance >30 ml/min er ikke nødvendig.
English: A dosing cup:
Danish: En doseringskop:
English: There is currently no experience on the safe use in patients with a creatinine clearance <10 ml/min and patients undergoing dialysis, therefore valsartan should be used with caution in these patients.
Danish: Der er på nuværende tidspunkt ingen erfaring vedrørende sikker brug hos patienter med kreatininclearance <10 ml/min og hos patienter i dialyse.
English: Cardiac disorders Uncommon
Danish: Mave-tarm-kanalen Ikke almindelig
English: Stopping your treatment with Diovan may cause your disease to get worse.
Danish: Din sygdom kan blive forværret, hvis du holder op med at tage Diovan.
English: EU/EEA Marketing Authorisation Holder
Danish: Indehaver af markedsføringstilladelse
English: Renal function and serum potassium should be closely monitored (see sections 4.4 and 5.2).
Danish: Nyrefunktion og serumkalium skal monitoreres tæt (se pkt.
English: Excretion:
Danish: Amning:
English: Potential risks: renal impairment, elevation of liver function values, hypersensitivity including angioedema and serum sickness, hemoglobin/hematocrit decreased and medication error including overdose.
Danish: nedsat hæmoglobin/hæmatokrit og medicineringsfejl, herunder overdosis.
English: GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally] 15.
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING [Udfyldes nationalt]
English: In patients with mild to moderate hepatic impairment without cholestasis, Diovan should be used with caution (see sections 4.2 and 5.2).
Danish: Diovan bør anvendes med forsigtighed til patienter med let til moderat nedsat leverfunktion uden cholestasis (se pkt.
English: o the usual dose is 40 mg of valsartan (corresponding to 13 ml of the solution).
Danish: • Hvis du vejer 35 kg eller mere o er den sædvanlige dosis 40 mg valsartan (svarende til 13 ml opløsning).
English: The signs may include rash, itching, hives.
Danish: Symptomerne kan være udslæt, kløe eller nældefeber.
English: Rash, Pruritis
Danish: Udslæt, pruritus
English: No dose adjustment is required for adult patients with creatinine clearance >10 ml/min (see sections 4.2 and 5.2).
Danish: Dosisjustering er ikke nødvendig hos voksne patienter med kreatininclearance >10 ml/min (se pkt.
English: This dose is 6 times the maximum recommended human dose on a mg/m2 basis
Danish: Denne dosis er 6 gange den maksimale anbefalede humane dosis baseret på mg/m2 (beregninger antager en oral dosis på 320 mg/dag og en patient på 60 kg).
English: If you take more Diovan than you should
Danish: Hvis du har taget for meget Diovan
English: • spinning sensation (vertigo)
Danish: • snurrende/svimlende følelse (svimmelhed)
English: OTHER SPECIAL WARNING(S), IF NECESSARY EXPIRY DATE
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER
English: • Keep out of the reach and sight of children.
Danish: • Opbevares utilgængeligt for børn
English: No dose adjustment is required for paediatric patients with a creatinine clearance >30 ml/min (see sections 4.2 and 5.2).
Danish: Dosisjustering til pædiatriske patienter med en kreatininclearance >30 ml/min er ikke nødvendig (se pkt.
English: Hydrochloric acid
Danish: Saltsyre
English: Increase in Blood Urea Nitrogen General disorders and administration site conditions Uncommon
Danish: Almene symptomer og reaktioner på administrationsstedet Ikke almindelig
English: BEFORE YOU TAKE DIOVAN
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE DIOVAN
English: Dizziness, Postural dizziness
Danish: Svimmelhed, stillingsbetinget svimmelhed
English: If any of these apply to you, do not take Diovan
Danish: Hvis noget af dette gælder for dig, bør du ikke tage Diovan
English: Reductions in systolic blood pressure were comparable in patients receiving valsartan (15 mmHg) and enalapril (14 mm Hg) (non-inferiority p-value <0.0001).
Danish: De patienter der vejede mellem 35 kg og <80 kg fik valsartan 160 mg eller enalapril 20 mg og de der var 80 kg fik valsartan 320 mg eller enalapril 40 mg. Sænkningen i systolisk blodtryk var ens for patienter, som fik valsartan (15 mmHg) og enalapril (14 mmHg) (non-inferioritet p-værdi <0,0001).
English: It is important to tell your doctor if you have:
Danish: Det er vigtigt, at du fortæller din læge, hvis du har:
English: Other available treatment options should be considered.
Danish: Andre tilgængelige behandlingsmuligheder skal overvejes.
English: If necessary you may receive additional salts.
Danish: Hvis det er nødvendigt, må du få yderligere salte.
English: The lowest possible effective dose should be applied.
Danish: Den lavest mulige effektive dosis skal anvendes.
English: Surgery and trauma:
Danish: Kirurgi og traume:
English: The maximum recommended daily dose must not be exceeded.
Danish: Den maksimale anbefalede daglige dosis må ikke overskrides.
English: The product information shall be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktinformationen kan efterfølgende opdateres af de relevante myndigheder i medlemsstaten i samarbejde med referencemedlemsstaten i overensstemmelse med procedurer beskrevet i kapitel 4 i afsnit III i Direktiv 2001/83/EC.
English: Do not use <Product name> if you:
Danish: Brug ikke <Produktnavn> hvis du:
English: In addition it will be ensured that you receive enough fluids.
Danish: Der vil endvidere blive sørget for, at du får nok væske.
English: • have too much fluid in your body and you have been told that you have a condition known as hyperhydration
Danish: • har for meget væske i kroppen, og du har fået fortalt, at du har en tilstand, som kaldes hyperhydrering
English: Your doctor will use the lowest possible effective dose and will not infuse <Product name> for more than 24 hours.
Danish: Din læge vil anvende den lavest mulige effektive dosis og vil ikke indgive <Produktnavn> i mere end 24 timer.
English: • have received an organ transplant
Danish: • har fået en organtransplantation
English: Frequency not known (cannot be estimated from the available data)
Danish: Frekvens ikke kendt (kan ikke vurderes ud fra tilgængelige data)
English: Surgery and trauma: Your doctor will consider carefully if this medicine is suitable for you.
Danish: Operation og traume: Din læge vil overveje nøje, om denne medicin er egnet til dig.
English: In the case of repeated administration, blood coagulation parameters should be monitored carefully.
Danish: I tilfælde af gentagen administration skal blodkoagulationsparametre monitoreres omhyggeligt.
English: The maximum daily dose is <30ml/kg for 6% HES (130/0.40) and 6% HES (130/0.42); for other HES products the maximum daily dose should be recalculated accordingly>.
Danish: Den maksimale daglige dosis er <30 ml/kg for 60 mg/ml HES (130/0,40) og 60 mg/ml HES (130/0,42); for andre HES-præparater skal den maksimale daglige dosis beregnes igen i henhold hertil>.
English: There is only limited experience of the use of this medicine in children.
Danish: Der er kun begrænset erfaring med brug af denne medicin til børn.
English: Section 4.3 Contraindications
Danish: Afsnit 4.3 Kontraindikationer
English: The expected benefit of treatment should be carefully weighed against uncertainty with regard to this long term safety.
Danish: De forventede fordele ved behandlingen skal afvejes nøje i forhold til den uvished, der er omkring sikkerheden på lang sigt.
English: Volume overload due to overdose or too rapid infusion must always be avoided.
Danish: Volumenoverbelastning på grund af overdosering eller for hurtig infusion skal altid undgås.
English: Your doctor will decide on the correct dose for you to receive.
Danish: Din læge fastsætter den korrekte dosis til dig.
English: An increased need for renal replacement therapy has been reported up to 90 days after HES administration.
Danish: Et øget behov for nyreerstatningsterapi er blevet rapporteret op til 90 dage efter HES-administration.
English: The relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.
Danish: De pågældende punkter i produktresuméet og indlægssedlen er resultatet af referral proceduren.
English: Your doctor will adjust the dose of <Product name> carefully in order to prevent fluid overload.
Danish: Din læge vil justere dosis af <Produktnavn> omhyggeligt for at undgå væskeoverbelastning.
English: • are allergic to any of the active substances or any of the other ingredients of this medicine
Danish: • er allergisk over for det aktive stof eller et af de øvrige indholdsstoffer i <Produktnavn>
English: - congestive heart failure
Danish: - kongestiv hjerteinsufficiens
English: • have been told that you have a severe increase of potassium [Note: only for products which contain potassium], sodium or chloride in your blood
Danish: • har fået fortalt, at du har en alvorlig stigning i mængden af kalium (bemærk: kun for præparater, som indeholder kalium), natrium eller chlorid i dit blod.
English: - severe coagulopathy - organ transplant patients
Danish: - svær koagulopati - organtransplantation
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Danish: Bilag III Ændringer til relevante afsnit i produktresuméer og indlægssedler
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V*.