FrancophonIA/ELRC3.0 huggingface dataset:
English: Work within the network to establish an EU communications strategy; Work to ensure availability for the Agency of the highest-quality expertise at EU level for evaluation of medicines and for monitoring and assessing their safety; Establish an inventory of available scientific expertise in the European medicines network; identify and complement insufficient expertise and plan for succession of established expertise; Develop an EU competence-development strategy and strengthen competence development at EU level.
Danish: Udarbejde en oversigt over den videnskabelige sagkundskab, der er tilgængelig i det europæiske lægemiddelnetværk; afdække og supplere områder, hvor der ikke er tilstrækkelig sagkundskab, og planlægge generationsskifte inden for den etablerede sagkundskab
English: Staff
Danish: Personale
English: Pharmacovigilance and post authorisation safety and efficacy of medicines
Danish: Lægemiddelovervågningog lægemidlers sikkerhed og virkninger efter godkendelse
English: Committee on Orphan Medicinal Products meetings 10-12 January
Danish: Møder i Udvalget for Lægemidler til Sjældne Sygdomme 10.-12. januar
English: Type-IA variations
Danish: Type-I-ændringer
English: For matters relating to pharmacovigilance for
Danish: For spørgsmål vedrørende lægemiddelovervågning Panos TSINTIS af humanmedicinske lægemidler
English: Direct telephone: (44-20) 75 23 7114 Fax: (44-20) 74 18 85 45
Danish: Fax: (44-20) 74 18 85 90 Tlf. nr. uden for arbejdstiden: (44-7880) 55
English: New medicinal products (non-orphan)
Danish: markeder uden for EU Lægemidler til sjældne sygdomme Nye lægemidler (ikke sjældne sygdomme)
English: applications New MRL applications
Danish: M RL ansøgninger om f o rlæ nge ls e / æ ndring M RL nye ansøgninger
English: Occupied as per
Danish: Besat pr.
English: medicinal products for human use
Danish: Humanmedicinske plantelægemidler
English: Line extensions
Danish: Produktserieudvidelser
English: Total grade B C*7
Danish: Lønklasse C i alt
English: Within a month following the Commission Decision
Danish: Inden for en måned efter kommissionens beslutning
English: Swallow the tablet whole with some water.
Danish: Synk tabletten hel med lidt vand.
English: and 4.8).
Danish: og 4.8).
English: Both of these substances help to control high blood pressure (hypertension).
Danish: Begge disse stoffer hjælper med at kontrollere for højt blodtryk (hypertension).
English: Fertility, prenatal development and postnatal development were unaffected in rats.
Danish: Fertilitet, prænatal og postnatal udvikling var upåvirket hos rotter.
English: Do not stop taking this medicine, even if you are feeling well (unless your doctor tells you to do so).
Danish: Du må ikke stoppe med denne medicin, selv om du har det godt (medmindre du har aftalt det med din læge).
English: These reduce the amount of angiotensin II the body can make.
Danish: Disse nedsætter den mængde angiotensin-II, kroppen kan producere.
English: As with many other medicines used to treat high blood pressure, this medicine may make you feel dizzy.
Danish: Som ved mange andre typer medicin, der bruges til behandling af forhøjet blodtryk, kan denne medicin få dig til at føle dig svimmel.
English: If this is the case, your doctor will tell you how to switch from that treatment to Riprazo HCT.
Danish: Hvis dette er tilfældet, vil din læge fortælle dig, hvordan du kan skifte fra den behandling til Riprazo HCT.
English: Do not use Riprazo HCT after the expiry date which is stated on the carton.
Danish: Brug ikke Riprazo HCT efter den udløbsdato, der står på pakningen.
English: Riprazo HCT may have been prescribed to you because your previous treatment did not lower your blood pressure enough.
Danish: Riprazo HCT kan være blevet ordineret til dig, fordi din tidligere behandling ikke sænkede dit blodtryk tilstrækkeligt.
English: Therefore the use of Riprazo HCT with an NSAID requires caution, especially in elderly patients.
Danish: Anvendelse af Riprazo HCT og et NSAID kræver derfor forsigtighed, især hos ældre patienter.
English: Hydrochlorothiazide has been extensively prescribed for many years, frequently in higher doses than those contained in Riprazo HCT.
Danish: Hydrochlorthiazid er blevet ordineret i stor udstrækning i mange år, ofte i højere dosis end indholdet i Riprazo HCT.
English: The safety of Riprazo HCT has been evaluated in 9 clinical trials with more than 3,900 patients, including over 700 treated for over 6 months, and 190 for over 1 year.
Danish: Riprazo HCT's sikkerhed er blevet evalueret i 9 kliniske forsøg med mere end 3.900 patienter, herunder over 700 behandlet i over 6 måneder og 190 i over 1 år.
English: As for any combination of two active substances, side effects associated with each individual component cannot be excluded.
Danish: Som for alle kombinationer af to aktive stoffer, kan bivirkninger, der er forbundet med hvert af de enkelte aktive stoffer, ikke udelukkes.
English: Aliskiren/hydrochlorothiazide Over 3,900 hypertensive patients received Riprazo HCT once daily in clinical trials.
Danish: Aliskiren/hydrochlorthiazid Mere end 3.900 hypertensive patienter har fået Riprazo HCT en gang dagligt i kliniske forsøg.
English: It is therefore recommended to monitor the effects when initiating and adjusting furosemide therapy to avoid possible underutilisation in clinical situations of volume overload.
Danish: Det anbefales derfor at monitorere virkningen ved initiering og justering af furosemidbehandling for at undgå potentiel underudnyttelse i kliniske situationer med volumen-overload.
English: No pharmacokinetic data are available in the paediatric population.
Danish: Der er ingen tilgængelige farmakokinetiske data for den pædiatriske population.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Danish: • senest 60 dage efter en vigtig milepæl er nået (lægemiddelovervågning eller risikominimering).
English: These could be symptoms of an increase of pressure in your eye and can happen within hours to weeks of taking Riprazo HCT.
Danish: Dette kan være symptomer på øget tryk i øjet og kan opstå inden for timer eller uger efter indtagelse af Riprazo HCT.
English: - if you experience a decrease in vision or eye pain.
Danish: - hvis du oplever nedsat syn eller øjensmerter.
English: No clinically relevant interactions have been identified.
Danish: Der er ikke identificeret interaktioner af klinisk betydning.
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.
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.
English: Packs containing 90 (3x30), 98 (2x49) or 280 (20x14) tablets are multi-packs.
Danish: Pakninger med 90 (3x30), 98 (2x49) eller 280 (20x14) tabletter er multipakninger.
English: The use of Riprazo HCT in children and adolescents up to 18 years of age is not recommended.
Danish: Riprazo HCT bør ikke anvendes til børn og unge op til 18 år.
English: Side effects reported in clinical studies for patients treated with Riprazo HCT were: Common (affecting less than 1 in 10 patients):
Danish: Bivirkninger indberettet fra kliniske forsøg med patienter behandlet med Riprazo HCT var: Almindelig (forekommer hos færre end 1 ud 10 patienter):
English: No carcinogenic potential for aliskiren was detected in a 2-year rat study and a 6-month transgenic mouse study.
Danish: Intet karcinogent potentiale blev observeret i et 2-årigt rottestudie og i et 6-måneders studie af transgene mus.
English: Riprazo HCT is used to treat high blood pressure.
Danish: Riprazo HCT anvendes til behandling af for højt blodtryk.
English: There is no evidence that Riprazo HCT would reduce or prevent diuretic-induced hyponatraemia.
Danish: Der er ingen dokumentation for, at Riprazo HCT vil reducere eller forhindre diuretikainduceret hyponatriæmi.
English: Warfarin: The effects of aliskiren on warfarin pharmacokinetics have not been evaluated.
Danish: Warfarin: Effekten af aliskiren på warfarins farmakokinetik er ikke blevet evalueret.
English: Conversely, it is anticipated that prokinetic substances such as cisapride may decrease the bioavailability of thiazidetype diuretics.
Danish: Omvendt forventes det, at prokinetiske stoffer som cisaprid kan nedsætte biotilgængeligheden af thiaziddiuretika.
English: If angioedema occurs, Riprazo HCT should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms has occurred.
Danish: Hvis angioødem opstår, skal Riprazo HCT seponeres med det samme, og der skal gives relevant behandling og monitorering indtil komplet og vedvarende resolution af tegn og symptomer indtræffer.
English: Additional information on individual components Other adverse reactions previously reported with one of the individual components may occur with Riprazo HCT even if not observed in clinical trials.
Danish: Yderligere oplysninger om individuelle komponenter Andre bivirkninger, der tidligere er blevet indberettet for en af de individuelle komponenter, kan forekomme med Riprazo HCT, selvom de ikke er blevet observeret i kliniske forsøg.
English: Riprazo HCT should be used with caution in patients with heart failure due to limited clinical efficacy and safety data.
Danish: Riprazo HCT skal anvendes med forsigtighed til patienter med hjertesvigt pga. begrænsede kliniske effekt- og sikkerhedsdata.
English: Like all medicines, Riprazo HCT can cause side effects, although not everybody gets them.
Danish: Riprazo HCT kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: However, when driving vehicles or operating machinery it must be borne in mind that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy.
Danish: Når man fører motorkøretøjer eller betjener maskiner, skal man imidlertid være opmærksom på, at der lejlighedsvis kan forekomme svimmelhed eller træthed under antihypertensiv behandling.
English: BLISTERS (PVC/PCTFE OR PA/ALU/PVC) BLISTER (CALENDAR) (PVC/PCTFE OR PA/ALU/PVC)
Danish: BLISTER (PVC/PCTFE ELLER PA/ALU/PVC) BLISTER (KALENDERPAKNING) (PVC/PCTFE ELLER PA/ALU/PVC)
English: Aliskiren should be used with caution in patients with serious congestive heart failure (New York Heart Association (NYHA) functional class III-IV).
Danish: Aliskiren bør anvendes med forsigtighed til patienter med svært hjertesvigt (New York Heart Association (NYHA) klasse III-IV).
English: During your treatment, your doctor may adjust your dose depending on your blood pressure response.
Danish: Under din behandling kan din læge justere din dosis afhængig af hvordan du reagerer på behandlingen.
English: Aliskiren Aliskiren is an orally active, non-peptide, potent and selective direct inhibitor of human renin.
Danish: Aliskiren Aliskiren er en oral aktiv, non-peptid, potent,selektiv og direkte hæmmer af humant renin.
English: • Decrease in vision or pain in your eyes due to high pressure (possible signs of acute-angle closure glaucoma)
Danish: • Nedsat syn eller øjensmerter på grund af højt tryk i øjet (mulige tegn på akut lukketvinklet glaukom)
English: Important information about some of the ingredients of Riprazo HCT Riprazo HCT contains lactose (milk sugar).
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Riprazo HCT Riprazo HCT indeholder laktose (mælkesukker).
English: The known aliskiren adverse drug reactions are presented in the table below using the same convention as described previously for the fixed combination.
Danish: De kendte bivirkninger ved aliskiren er præsenteret i tabellen herunder ved brug af de samme konventioner, som tidligere er beskrevet for faste kombinationer.
English: Riprazo HCT is unlikely to affect the ability to drive and use machines.
Danish: Det er usandsynligt, at Riprazo HCT påvirker evnen til at føre motorkøretøj eller betjene maskiner.
English: Riprazo HCT is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy (see section 5.2).
Danish: Riprazo HCT bør ikke anvendes til børn og unge under 18 år pga. manglende dokumentation for sikkerhed og virkning (se pkt.
English: hands and feet, eyes, lips and/or tongue).
Danish: hænder og fødder, øjenomgivelser, læber og/eller tunge (angioødem).
English: You may need to stop Riprazo HCT.
Danish: Det kan være nødvendigt at stoppe behandlingen med Riprazo HCT.
English: In controlled clinical trials, the incidence of diarrhoea in Riprazo HCT-treated patients was 1.3% compared to 1.4% for aliskirenor 1.9% for hydrochlorothiazide-treated patients.
Danish: I kontrollerede, kliniske forsøg var incidensen af diarré hos Riprazo HCT-behandlede patienter 1,3 %, sammenlignet med 1,4 % for aliskiren- eller 1,9 % for hydrochlorthiazidbehandlede patienter.
English: Impotence General disorders and administration site conditions Not known:
Danish: Impotens Almene symptomer og reaktioner på administrationsstedet Ikke kendt:
English: Always take Riprazo HCT exactly as your doctor has told you.
Danish: Tag altid Riprazo HCT nøjagtigt efter lægens anvisning.
English: Pharmacotherapeutic group: Renin inhibitor (aliskiren) combinations with diuretics (hydrochlorothiazide), ATC code: C09XA52
Danish: Farmakoterapeutisk klassifikation: Reninhæmmer (aliskiren) kombinationer med diuretika (hydrochlorthiazid), ATC-kode: C09XA52
English: Information on Riprazo HCT interactions
Danish: Information om interaktioner med Riprazo HCT
English: As with any antihypertensive agent, excessive reduction of blood pressure in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Danish: Som ved alle antihypertensiva kan en for stor reduktion af blodtrykket hos patienter med iskæmisk kardiomyopati eller iskæmisk kardiovaskulær sygdom føre til myokardieinfarkt eller slagtilfælde.
English: Aliskiren was devoid of any mutagenic potential, embryo-foetal toxicity or teratogenicity.
Danish: Aliskiren havde ikke noget mutagent potentiale, embryo-føtal toksicitet eller teratogenicitet.
English: Your doctor may need to change your dose and/or take other precautions if you are taking one of the following medicines: - furosemide, a medicine belonging to the type known as diuretics, or water tablets, which is used to increase the amount of urine you produce.
Danish: Det kan være nødvendigt for din læge at ændre din dosis og/eller tage andre forholdsregler, hvis du tager et af følgende lægemidler: - furosemid, medicin, der tilhører gruppen af diuretika, også kaldet vanddrivende tabletter og bruges til at øge urinproduktionen.
English: P-gp substrates or weak inhibitors: No relevant interactions with atenolol, digoxin, amlodipine or cimetidine have been observed.
Danish: P-gp-substrater og svage P-gp-hæmmere: Der er ikke observeret nogen relevante interaktioner med atenolol, digoxin, amlodipin eller cimetidin.
English: Riprazo HCT should be discontinued if hypercalcaemia develops during treatment.
Danish: Riprazo HCT skal seponeres, hvis der udvikles hyperkalcæmi under behandlingen.
English: Blood and lymphatic system disorders Rare:
Danish: Blod og lymfesystem Sjælden:
English: General In the event of severe and persistent diarrhoea, Riprazo HCT therapy should be stopped.
Danish: Generelt I tilfælde af alvorlig og vedvarende diarré bør behandling med Riprazo HCT stoppes.
English: Safety pharmacology studies with aliskiren did not reveal any adverse effects on central nervous, respiratory or cardiovascular function.
Danish: Sikkerhedsfarmakologistudier med aliskiren afslørede ingen bivirkninger på funktionen af centralnervesystemet og respiratorisk eller kardiovaskulær funktion.
English: Methyldopa: There have been isolated reports of haemolytic anaemia occurring with concomitant use of hydrochlorothiazide and methyldopa.
Danish: Methyldopa: Der har været isolerede rapporter om hæmolytisk anæmi, som er opstået ved samtidig brug af hydrochlorthiazid og methyldopa.
English: The following adverse reactions have been reported in patients treated with thiazide diuretics alone, including hydrochlorothiazide:
Danish: Følgende bivirkninger er blevet rapporteret hos patienter behandlet med thiaziddiuretika alene, inklusive hydrochlorthiazid:
English: Therefore, because of the risk of therapeutic failure, grapefruit juice should not be taken together with Riprazo HCT.
Danish: På grund af risiko for terapeutisk svigt bør grapefrugtjuice ikke tages sammen med Riprazo HCT.
English: Riprazo HCT tablets contain two active substances, called aliskiren and hydrochlorothiazide.
Danish: Riprazo HCT-tabletter indeholder to aktive stoffer, som kaldes aliskiren og hydrochlorthiazid.
English: Following oral administration of Riprazo HCT tablets, the median peak plasma concentration time is within 1 hour for aliskiren and 2.5 hours for hydrochlorothiazide.
Danish: Efter oral indgivelse af Riprazo HCT-tabletter er tiden for middel peak-plasmakoncentrationen under 1 time for aliskiren og 2,5 timer for hydrochlorthiazid.
English: Your doctor will normally advise you to stop taking Riprazo HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Riprazo HCT.
Danish: Normalt vil din læge råde dig til at stoppe med at tage Riprazo HCT, inden du bliver gravid, eller så snart du har konstateret, at du er gravid.
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 toksicitetsstudier med gentagne doser i dyr var i overensstemmelse med det kendte potentiale for lokalirritation eller de forventede farmakologiske effekter af aliskiren.
English: If Riprazo HCT is used during breast-feeding, doses should be kept as low as possible.
Danish: Hvis Riprazo HCT anvendes under amning, bør dosis holdes så lav som muligt.
English: Aliskiren is a substance that belongs to a new group of medicines called renin inhibitors.
Danish: Aliskiren er et stof, der hører til en ny klasse af medicin, kaldet reninhæmmere.
English: Multi-packs containing 90, 98 or 280 tablets.
Danish: Multipakninger med 90, 98 eller 280 tabletter.
English: Riprazo HCT is not recommended during pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Danish: Riprazo HCT frarådes under graviditeten og må ikke tages, når du er mere end 3 måneder henne i graviditeten, fordi det kan forårsage alvorlig skade på dit barn, hvis det tages efter tredje graviditetsmåned.
English: Renal dysfunction, acute renal failure Reproductive system and breast disorders Common:
Danish: Renal dysfunktion, akut nyresvigt Det reproduktive system og mammae Almindelig:
English: Cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, vasculitis necrotising and toxic epidermal necrolysis
Danish: Kutan lupus erythematosus-lignende reaktioner, reaktivering af kutan lupus erythematosus, nekrotiserende vaskulitis og toksisk epidermal
English: Food interactions: Meals with a high fat content have been shown to reduce the absorption of aliskiren substantially.
Danish: Fødeindtag: Måltider med højt fedtindhold har vist at reducere absorptionen af aliskiren betragteligt.
English: The rate and extent of absorption of Riprazo HCT are equivalent to the bioavailability of aliskiren and hydrochlorothiazide when administered as individual monotherapies.
Danish: Hastigheden og omfanget af absorptionen af Riprazo HCT svarer til biotilgængeligheden for aliskiren og hydrochlorthiazid, når det indgives som individuelle monoterapier.
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: Antidiabetic agents (e.g. insulin and oral antidiabetic agents): Thiazides may alter glucose tolerance.
Danish: Antidiabetika (fx insulin og orale midler): Thiazider kan ændre glucosetolerancen.
English: Riprazo HCT contains lactose.
Danish: Riprazo HCT indeholder laktose.
English: The recommended dose of Riprazo HCT is one tablet per day.
Danish: Den anbefalede dosis af Riprazo HCT er en tablet pr. dag.
English: Riprazo HCT combines two antihypertensive compounds to control blood pressure in patients with essential hypertension: Aliskiren belongs to the class of direct renin inhibitors and hydrochlorothiazide to the class of thiazide diuretics.
Danish: Riprazo HCT kombinerer to antihypertensive komponenter til kontrol af blodtryk hos patienter med essentiel hypertension: Aliskiren tilhører klassen af direkte reninhæmmere og hydrochlorthiazid tilhører klassen af thiaziddiuretika.
English: You should not take Riprazo HCT together with grapefruit juice.
Danish: Du må ikke tage Riprazo HCT sammen med grapefrugtjuice.
English: Treatment with Aliskiren up to 300 mg resulted in an overall incidence of adverse reactions similar to placebo.
Danish: Behandling med Aliskiren op til 300 mg resulterede i en generel incidens af bivirkninger, der svarede til placebo.
English: Riprazo HCT 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: Riprazo HCT frarådes i den tidlige periode af graviditeten og må ikke tages, hvis du er mere end 3 måneder henne i graviditeten, da det kan forårsage alvorlig skade på dit barn, hvis det tages på dette tidspunkt (se afsnittet om Graviditet).
English: If blood pressure remains uncontrolled after 2-4 weeks of therapy, the dose may be titrated up to a maximum of Riprazo HCT 300 mg/25 mg daily.
Danish: Hvis blodtrykket ikke er under kontrol efter 2-4 ugers behandling kan dosis titreres op til en maksimal daglig dosis på 300 mg/25 mg Riprazo HCT.
English: As a result no dose adjustment for aliskiren or these coadministered medicinal products is necessary.
Danish: Dosisjustering for aliskiren eller disse samtidigt administrerede lægemidler er derfor ikke nødvendig.
English: Other antihypertensive agents: The antihypertensive effect of Riprazo HCT may be increased with the concomitant use of other antihypertensive agents.
Danish: Andre antihypertensiva: Riprazo HCT's antihypertensive virkning kan øges ved samtidig brug af andre antihypertensiva.
English: Furosemide: When aliskiren was co-administered with furosemide, the AUC and Cmax of furosemide were reduced by 28% and 49%, respectively.
Danish: Furosemid: Når aliskiren blev administreret sammen med furosemid, faldt AUC og Cmax for furosemid med henholdsvis 28 % og 49 %.
English: If any of the above applies to you, do not take Riprazo HCT and talk to your doctor.
Danish: Hvis noget af dette gælder for dig, skal du ikke tage Riprazo HCT og fortælle det til lægen.
English: Medicinal products affecting serum sodium level: The hyponatraemic effect of diuretics may be intensified by concomitant administration of medicinal products such as antidepressants, antipsychotics, antiepileptics, etc.
Danish: Lægemidler der påvirker serumnatrium: Den hyponatriæmiske virkning af diuretika kan forstærkes ved samtidig administration af lægemidler som antidepressiva, antipsykotika, antiepileptika osv.
English: Take special care with Riprazo HCT - if you have impaired kidney function, your doctor will carefully consider whether Riprazo HCT
Danish: Vær ekstra forsigtig med at tage Riprazo HCT - hvis du har nedsat nyrefunktion, vil din læge nøje overveje, om Riprazo HCT er egnet til dig,