FrancophonIA/ELRC3.0 huggingface dataset:
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report
Danish: I overensstemmelse med CHMP-retningslinjerne for risikostyringsprogrammer for lægemidler til mennesker skal den opdaterede RMP fremsendes samtidig med den næste periodiske
English: If anaphylactic reactions or angioedema occur, Riprazo should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms has occurred.
Danish: Hvis anafylaktiske reaktioner eller angioødem opstår, skal Riprazo seponeres med det samme, og der skal iværksættes relevant behandling og monitorering, indtil komplet og vedvarende resolution af tegn og symptomer indtræffer.
English: The MAH shall submit an updated risk management plan (RMP) that adequately describes all the safety concerns, the pharmacovigilance activities and the interventions designed to identify, characterise, prevent or minimise the risks within a month following the Commission Decision of the renewal procedure (EMEA/H/C/853/R/068).
Danish: Indehaveren af markedsføringstilladelsen skal indsende et opdateret risikostyringsprogram (RMP), som på tilstrækkelig vis beskriver alle sikkerhedsproblemer, lægemiddelovervågningsaktiviteter og tiltag, som er udformet med henblik på at identificere, karakterisere, forebygge eller minimere risici, inden for én måned efter Kommissionsbeslutningen for genregistrerinsproceduren (EMEA/H/C/853/R/068).
English: Riprazo tablets contain an active substance called aliskiren.
Danish: Riprazo-tabletter indeholder et aktivt stof, som kaldes aliskiren.
English: Preliminary study results indicated a hazard ratio for the primary endpoint of 1.09 in favour of placebo (95% Confidence Interval: 0.97, 1.22, 2-sided p=0.17).
Danish: Præliminære resultater fra studiet indikerede en hazard ratio for det primære endepunkt på 1,09 til fordel for placebo (95 % konfidensinterval: 0,97-1,22, 2-sidet p=0,17).
English: Serious adverse reactions include anaphylactic reaction and angioedema which have been reported in post-marketing experience and may occur rarely (less than 1 case per 1,000 patients).
Danish: Alvorlige bivirkninger omfatter anafylaktiske reaktioner og angioødem, som er blevet rapporteret efter markedsføringen, og forekommer sjældent (mindre end 1 tilfælde ud af 1.000 patienter).
English: Beneficial effects of Riprazo on mortality and cardiovascular morbidity and target organ damage are
Danish: Gavnlige virkninger af Riprazo med hensyn til mortalitet, kardiovaskulær morbiditet og organskade er
English: The effects of Riprazo on warfarin pharmacokinetics have not been evaluated.
Danish: Effekten af Riprazo på warfarins farmakokinetik er ikke blevet evalueret.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Riprazo in one or more subsets of the paediatric population in hypertension (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Riprazo i en eller flere undergrupper af den pædiatriske population med hypertension (se pkt.
English: Riprazo has negligible influence on the ability to drive and use machines.
Danish: Riprazo påvirker i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Riprazo was secreted in the milk of lactating rats.
Danish: Riprazo udskilles i mælken hos diegivende rotter.
English: You should not take this medicine
Danish: Du må ikke tage dette
English: - if you are allergic to aliskiren or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for aliskiren eller et af de øvrige indholdsstoffer i Riprazo (angivet i punkt 6).
English: Riprazo should be taken with a light meal once a day, preferably at the same time each day.
Danish: Riprazo bør tages med et let måltid mad én gang daglig, fortrinsvis på samme tidspunkt hver dag.
English: The MAH shall submit the final results and study report for the active treatment phase of the ALTITUDE study when available
Danish: Indehaveren af markedsføringstilladelsen skal indsende de endelige resultater og studierapporten for den aktive behandlingsfase fra ALTITUDE-studiet, når
English: Riprazo induced an additive blood-pressure-lowering effect when added to hydrochlorothiazide.
Danish: Riprazo inducerede en additiv blodtrykssænkende virkning ved kombination med hydrochlorthiazid.
English: Excessive hypotension was uncommonly (0.1%) seen in patients with uncomplicated hypertension treated with Riprazo alone.
Danish: Kraftig hypotension var usædvanlig (0,1 %) hos patienter med ukompliceret hypertension, som blev behandlet med Riprazo alene.
English: Anaphylactic reactions, hypersensitivity reactions
Danish: Anafylaktiske reaktioner, overfølsomhedsreaktioner
English: Aliskiren belongs to a class of medicines called renin inhibitors.
Danish: Aliskiren tilhører en klasse af medicin, kaldet reninhæmmere.
English: At steady state meals with low fat content reduce Cmax by 76% and AUC0tau by 67% in hypertensive patients.
Danish: Ved steady state reducerer måltider med lavt fedtindhold Cmax med 76 % og AUC0-tau med 67 % hos hypertensive patienter.
English: - Organic anion transporting polypeptide (OATP) inhibitors Preclinical studies indicate that aliskiren might be a substrate of organic anion transporting polypeptides.
Danish: - Hæmmere af organisk anion-transporterende polypeptid (OATP) Prækliniske studier tyder på, at aliskiren kan være et substrat for organisk anion-transporterende polypetider.
English: The usual starting dose is one 150 mg tablet once daily.
Danish: Den sædvanlige startdosis er en tablet på 150 mg én gang daglig.
English: In post-marketing experience, renal dysfunction and cases of acute renal failure have been reported in
Danish: Efter markedsføring er der rapporteret om renal dysfunktion og tilfælde af akut nyresvigt hos
English: You may
Danish: Det kan være
English: However, when driving vehicles or operating machinery it must be borne in mind that dizziness or weariness may occasionally
Danish: Når man fører motorkøretøjer eller betjener maskiner, skal man være opmærksom på, at der lejlighedsvis kan optræde svimmelhed eller træthed under behandling med Riprazo.
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; renin inhibitor, ATC code: C09XA02
Danish: Farmakoterapeutisk klassifikation: Stoffer, der virker på renin-angiotensin-systemet, reninhæmmer, ATC-kode: C09XA02
English: - if you have serious congestive heart failure (a type of heart disease where the heart cannot
Danish: - hvis du har alvorlig hjertesvigt (en hjertesygdom, hvor dit hjerte ikke kan pumpe nok blod rundt
English: The safety and efficacy of Riprazo in children aged below 18 years have not yet been established.
Danish: Pædiatrisk population Riprazos sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: The recommended dose of Riprazo is 150 mg once daily.
Danish: Den anbefalede dosis af Riprazo er 150 mg én gang dagligt.
English: • Deadlines for submission of the APOLLO study results.
Danish: • tidsfrister for indsendelse af rapport over studieresultater fra APOLLO.
English: The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at det lægemiddelovervågningssystem, som er beskrevet i modul 1.8.1 i markedsføringstilladelsen, er på plads og fungerer før og under
English: - Digoxin and verapamil bioavailability may be slightly decreased by Riprazo.
Danish: - Biotilgængeligheden af digoxin og verapamil kan blive lettere nedsat af Riprazo.
English: In the event of severe and persistent diarrhoea, Riprazo therapy should be stopped (see section 4.8).
Danish: Ved alvorlig og vedvarende diarré bør behandling med Riprazo stoppes (se pkt.
English: - A commitment to submit the final study report of the epidemiological
Danish: • en forpligtelse til at indsende den endelige studierapport for det epidemiologiske studie om
English: Contraindicated (see section 4.3)
Danish: Kontraindiceret (se pkt.
English: You should take this medicine with a light meal once a day, preferably at the same time each day.
Danish: Du bør tage dette lægemiddel sammen med et let måltid mad, én gang daglig, fortrinsvis på samme tidspunkt hver dag.
English: Although aliskiren has known irritation potential, safety margins obtained in humans at the dose of 300 mg during a study in healthy volunteers were considered to be appropriate at 9-11-fold based on faecal concentrations or 6-fold based on mucosa concentrations in comparison with 250 mg/kg/day in the rat carcinogenicity study.
Danish: Selvom aliskiren har et kendt irritationspotentiale blev de opnåede sikkerhedsmargener i et studie på raske frivillige forsøgspersoner hos mennesker ved en dosis på 300 mg anset for at være passende ved 9-11 gange baseret på fækale koncentrationer eller 6 gange baseret på koncentrationerne i mucosa, sammenlignet med 250 mg/kg/dag i karcinogenitetsstudiet hos
English: - if you have renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
Danish: - hvis du har nyrearteriestenose (forsnævring af blodtilførslen til en eller begge nyrer).
English: In experimental animals, it has been shown that P-gp is a major determinant of Riprazo bioavailability.
Danish: I forsøgsdyr er det blevet vist a P-gp har stor indflydelse på Riprazos biotilgængelighed.
English: In addition, an increased incidence of serious adverse outcomes was observed with aliskiren compared to placebo for renal complications (4.7% versus 3.3%), hyperkalaemia (36.9% versus 27.1%), hypotension (18.4% versus 14.6%) and stroke (2.7% versus 2.0%).
Danish: Desuden blev der observeret en øget forekomst af alvorlige hændelser ved aliskiren sammenlignet med placebo; nyrekomplikationer (4,7 % vs. 3,3 %), hyperkaliæmi (36,9 % vs. 27,1 %), hypotension (18,4 % vs. 14,6 %) og apopleksi (2,7 % vs. 2,0 %).
English: No controlled clinical data are available on the use of Riprazo in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Danish: Der er ingen tilgængelige kontrollerede kliniske data om brug af Riprazo til patienter med unilateral eller bilateral nyrearteriestenose eller brug af Riprazo til patienter med stenose i en enkelt nyre.
English: - Compounds that have been investigated in clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate and hydrochlorothiazide.
Danish: - Stoffer, som er undersøgt i kliniske farmakokinetiske studier inkluderer acenocoumarol, atenolol, celecoxib, pioglitazon, allopurinol, isosorbid-5-mononitrat og hydrochlortiazid.
English: or an “angiotensin II receptor blocker” such as valsartan, telmisartan, irbesartan etc.
Danish: eller en ”angiotensin-II receptorblokker”, som fx valsartan, telmisartan, irbesartan osv.
English: Immune system disorders
Danish: Immunsystemet Sjælden:
English: If you take more Riprazo than you should If you have accidentally taken too many Riprazo tablets, consult a doctor immediately.
Danish: Hvis du er kommet til at tage for mange tabletter af Riprazo, skal du straks kontakte en læge.
English: Increased aliskiren exposure during co-administration of CYP3A4 inhibitors that also inhibit P-gp can therefore be expected (see other P-gp references in section 4.5).
Danish: Øget aliskiren-eksponering ved samtidig administration af CYP3A4-hæmmere, som også hæmmer P-gp, kan derfor forventes (se også andre afsnit om P-gp-interaktioner i pkt.
English: - A description and timelines for the new study replacing APOLLO and designed to elucidate efficacy and safety in the elderly, including gastrointestinal cancer as a pre-specified endpoint.
Danish: - rn beskrivelse og tidslinjer af det nye studie, som erstatter APOLLO, der er designet til at belyse effekt og sikkerhed hos ældre, inklusive gastrointestinal cancer, som et forud specificeret endepunkt.
English: • A description and timelines for the new study replacing APOLLO and designed to elucidate efficacy and safety in the elderly, including gastrointestinal cancer as a pre-specified endpoint.
Danish: • en beskrivelse og tidslinjer af det nye studie, som erstatter APOLLO, der er designet til at belyse effekt og sikkerhed hos ældre, inklusive gastrointestinal cancer, som et forud
English: When aliskiren was co-administered with furosemide, the AUC and Cmax of furosemide were reduced by 28% and 49%, respectively.
Danish: Når aliskiren blev administreret sammen med furosemid, faldt AUC og Cmax for furosemid med henholdsvis 28 % og 49 %.
English: an “angiotensin II receptor blocker” such as valsartan, telmisartan, irbesartan etc. - if you have impaired kidney function, your doctor will carefully consider whether Riprazo is suitable for you and may wish to monitor you carefully.
Danish: en ”angiotensin-II receptorblokker”, som fx valsartan, telmisartan, irbesartan osv. - hvis du har nedsat nyrefunktion, vil din læge nøje overveje, om Riprazo er egnet til dig, og kan
English: Grapefruit juice should not be taken together with Riprazo (see section 4.5).
Danish: Grapefrugtjuice må ikke tages sammen med Riprazo (se pkt.
English: - Co-administration of aliskiren with either metformin (↓28%), amlodipine (↑29%) or cimetidine (↑19%) resulted in between 20% and 30% change in Cmax or AUC of Riprazo.
Danish: - Samtidig administration af aliskiren med enten metformin (↓28 %), amlodipin (↑29 %) eller cimetidin (↑19 %) resulterede i en ændring af Cmax eller AUC for Riprazo på mellem 20 % og 30 %.
English: This effect is also seen with other agents acting on the reninangiotensin system, such as ACEIs and ARBs.
Danish: Denne virkning ses også med andre stoffer, som virker på renin-angiotensin-systemet, fx ACE-hæmmere og ARB'er.
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Danish: Indehaveren af markedsføringstilladelsen skal udføre de lægemiddelopvervågningsaktiviteter, som er beskrevet i lægemiddelovervågningsplanen (ifølge aftalen i RMP, modul 1.8.2 i markedsføringstilladelsen), og enhver efterfølgende opdatering af RMP, som er godkendt af Udvalget
English: However, as with other medicinal products acting on the renin-angiotensin system, there is an increased risk of renal insufficiency, including acute renal failure, when patients with renal artery stenosis are treated with aliskiren.
Danish: Der er dog, ligesom for andre lægermidler, der virker på renin-angiotensin-systemet, en øget risiko for nyreinsufficiens, inklusive akut nyresvigt, når patienter med nyrearteriestenose behandles med aliskiren.
English: - A description and timelines for the new observational study on incidence of colorectal hyperplasia in aliskiren-treated patients.
Danish: - en beskrivelse og tidslinjer for et nyt observationsstudie om forekomsten af kolorektal hyperplasi hos aliskiren behandlede patienter.
English: In clinical studies Riprazo has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μmol/l or 1.70 mg/dl in women and ≥ 177 μmol/l or 2.00 mg/dl in men and/or estimated GFR < 30 ml/min/1.73 m2), history of dialysis, nephrotic syndrome or renovascular hypertension.
Danish: Riprazo er ikke undersøgt i kliniske studier med hypertensive patienter, der har svært nedsat nyrefunktion (serumkreatinin ≥ 150 μmol/l eller 1,70 mg/dl hos kvinder og ≥ 177 μmol/l eller 2,00 mg/dl hos mænd og/eller estimeret GFR < 30 ml/min./1,73 m2), tidligere dialyse, nefrotisk syndrom eller renovaskulær hypertension.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
Danish: Fortæl altid lægen eller på apoteket, hvis du bruger anden medicin eller har gjort det for nylig.
English: Findings during repeat-dose toxicity studies in animals were consistent with the known local irritation potential or the expected pharmacological effects of aliskiren.
Danish: Hændelser under gentagen-dosis toksicitetsstudier i dyr var i overensstemmelse med det kendte potentiale for lokalirritation eller de forventede
English: As with other medicinal products acting on the renin-angiotensin system, angioedema or symptoms suggestive of angioedema (swelling of the face, lips, throat and/or tongue) have been reported in patients treated with aliskiren.
Danish: Som ved andre lægemidler, der virker på renin-angiotensin-systemet, er angioødem eller symptomer, som tyder på angioødem (hævet ansigt, læber, svælg og/eller tunge) blevet rapporteret hos patienter, som behandles med aliskiren.
English: Coadministration of Riprazo had no significant impact on atorvastatin, metformin or amlodipine pharmacokinetics.
Danish: Samtidig administration af Riprazo havde ingen signifikant indvirkning på atorvastatins, metformins eller amlodipins farmakokinetik.
English: Riprazo may be used alone or in combination with other antihypertensive agents with the exception of use in combination with angiotensin converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB) in patients with diabetes mellitus or renal impairment (glomerular filtration rate
Danish: Riprazo kan anvendes alene eller kombineres med andre antihypertensiva dog ikke i kombination med angiotensin-konverteringsenzym (ACE)-hæmmere eller angiotensin-II receptorblokkere (ARB) hos patienter med diabetes mellitus eller nedsat nyrefunktion (glomerulær filtrationsrate (GFR)
English: Description of selected adverse reactions Hypersensitivity reactions including anaphylactic reactions and angioedema have occurred during
Danish: Overfølsomhedsreaktioner inklusive anafylaktiske reaktioner og angioødem er forekommet under
English: Patients should be informed to report to the physician any signs suggestive of allergic reactions, in particular difficulties in breathing or swallowing, swelling of face, extremities, eyes, lips or tongue.
Danish: Patienter skal informeres om at kontakte læge, hvis de udvikler tegn på allergiske reaktioner, specielt vejrtrækningsproblemer eller synkebesvær, hævelse i ansigt, arme og ben, øjne, læber eller tunge.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG
English: - The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-gp inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated (see section 4.5).
Danish: - Brug af aliskiren sammen med ciclosporin eller itraconazol, to yderst potente P-glykoprotein(P-gp)-hæmmere, eller andre potente P-gp-hæmmere (fx quinidin) er kontraindiceret (se pkt.
English: In hypertensive patients, once-daily administration of Riprazo at doses of 150 mg and 300 mg provided dose-dependent reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval (maintaining benefit in the early morning) with a mean peak to trough ratio for diastolic response of up to 98% for the 300 mg dose.
Danish: Hos hypertensive patienter gav administration af Riprazo en gang dagligt i doser på 150 mg og 300 mg dosisafhængige reduktioner i både det systoliske og det diastoliske blodtryk, som blev opretholdt over hele dosisintervallet på 24 timer (med vedvarende gavnlig virkning tidligt om morgenen) med en gennemsnitlig peak/trough ratio for diastolisk respons på op til 98 % for 300-mgdosen.
English: - Timelines to submit further data on colorectal hyperplasia events from
Danish: • tidslinjer for indsendelse af yderligere data om hændelser af kolorektal hyperplasi fra
English: Inducers of P-gp (St. John's wort, rifampicin) might therefore decrease the bioavailability of Riprazo.
Danish: Inducere af P-gp (perikon, rifampicin) kan derfor nedsætte biotilgængeligheden af Riprazo.
English: Meals (low or high fat content) have been shown to reduce the absorption of Riprazo substantially
Danish: Måltider (med højt eller lavt fedtindhold) reducerer absorptionen af Riprazo betragteligt (se pkt.4.2).
English: In patients who did not adequately respond to 5 mg of the calcium channel blocker amlodipine, the addition of Riprazo 150 mg had a blood-pressure-lowering effect similar to that obtained by increasing amlodipine dose to 10 mg, but had a lower incidence of oedema (aliskiren 150 mg/amlodipine 5 mg 2.1% vs. amlodipine 10 mg 11.2%).
Danish: Hos patienter, som ikke responderede tilstrækkeligt på 5 mg af calciumantagonisten amlodipin, havde kombinationen med Riprazo 150 mg en blodtrykssænkende virkning, som svarede til den opnåede virkning ved at amlodipindosen blev øget til 10 mg, men med en lavere incidens af ødem (aliskiren 150 mg/amlodipin 5 mg 2,1 % kontra amlodipin 10 mg 11,2 %).
English: Riprazo is not recommended in patients with severe renal impairment
Danish: Riprazo anbefales ikke til patienter med stærkt nedsat nyrefunktion
English: The assays included in vitro assays in bacterial and mammalian cells and in vivo assessments in rats.
Danish: Analyserne omfattede in vitro-analyser af bakterie- og pattedyrsceller og in vivo-vurderinger hos
English: Detailed information on this medicine is available on the European Medicines Agency website:
Danish: Ydeligere information om Riprazo findes på Det Europæiske Lægemiddelagenturs hjemmeside
English: • OBLIGATION TO CONDUCT POST-AUTHORISATION MEASURES The MAH shall complete, within the stated timeframe, the following measures:
Danish: Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme afslutte følgende
English: As a result no dose adjustment for Riprazo or these co-administered
Danish: Dosisjustering for Riprazo eller disse samtidigt administrerede lægemidler er derfor ikke nødvendig.
English: In obese hypertensive patients who did not adequately respond to HCTZ 25 mg, add-on treatment with Riprazo 300 mg provided additional blood pressure reduction that was comparable to add-on treatment with irbesartan 300 mg or amlodipine 10 mg.
Danish: Hos adipøse patienter med utilstrækkelig respons på HCTZ 25 mg gav tillægsbehandling med Riprazo 300 mg en yderligere blodtryksnedsættende effekt, som var sammenlignelig med tillægsbehandling af irbesartan 300 mg eller amlodipin 10 mg.
English: In post-marketing experience, cases of angioedema or angioedema-like reactions have been reported when aliskiren was co-administered with ACEIs and/or ARBs.
Danish: Efter markedsføring er der rapporteret tilfælde af angioødem eller angioødem-lignende reaktioner, når aliskiren blev administreret sammen med ACE-hæmmere og/eller ARB'er.
English: Compared to a diuretic (hydrochlorothiazideHCTZ), Riprazo 300 mg lowered systolic/diastolic blood pressure by 17.0/12.3 mmHg, compared to 14.4/10.5 mmHg for HCTZ 25 mg after 12 weeks of treatment.
Danish: Sammenlignet med et diuretikum (hydrochlortiazid - HCTZ) sænkede Riprazo 300 mg det systoliske/diastoliske blodtryk med 17,0/12,3 mmHg sammenlignet med 14,4/10,5 mmHg for HCTZ
English: Riprazo monotherapy studies have shown blood pressure lowering effects comparable to other classes of antihypertensive agents including ACEI and ARB.
Danish: Undersøgelser af Riprazo-monoterapi har vist en blodtrykssænkende effekt, som er sammenlignelig med andre klasser af antihypertensiva, herunder ACE-hæmmere og angiotension-II-antagonister.
English: A single dose interaction study in healthy subjects has shown that ciclosporin (200 and 600 mg) increases Cmax of aliskiren 75 mg approximately 2.5-fold and AUC approximately 5-fold.
Danish: Et interaktionsforsøg med raske personer, hvor dosis blev administreret en gang, har vist, at ciclosporin (200 og 600 mg) øger Cmax af aliskiren 75 mg cirka 2,5 gange og AUC cirka 5 gange.