FrancophonIA/ELRC3.0 huggingface dataset:
English: Most studies involved patients with mild to moderate hypertension and one involved patients with severe hypertension.
Danish: De fleste undersøgelser omfattede patienter med mild til moderat hypertension, og en af undersøgelserne omfattede patienter med svær hypertension.
English: Three additional studies were carried out to show that the active substances were absorbed in the body in the same way when they taken as separate tablets and as Riprazo HCT.
Danish: Der blev udført tre yderligere undersøgelser for at vise, at de aktive stoffer bliver absorberet i kroppen på samme måde, når de tages som separate tabletter og som Riprazo HCT.
English: For more information about treatment with Riprazo HCT, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Riprazo HCT, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The company presented information used in the assessment of aliskiren and from the published literature to support its application for Riprazo HCT, as well as information from additional studies.
Danish: Virksomheden fremlagde information, der blev anvendt ved vurderingen af aliskiren, og information fra den offentliggjorte litteratur til støtte for sin ansøgning om Riprazo HCT, og den fremlagde desuden information fra yderligere undersøgelser.
English: Riprazo HCT is used to treat essential hypertension (high blood pressure) in adults.
Danish: Riprazo HCT anvendes til behandling af essentiel hypertension (for højt blodtryk) hos voksne.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Riprazo HCT.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Riprazo HCT.
English: Other information about Riprazo HCT
Danish: Andre oplysninger om Riprazo HCT
English: Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension.
Danish: Hydrochlorothiazid er et diuretikum, som er en anden type behandling af hypertension.
English: The CHMP decided that Riprazo HCT's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Riprazo HCT er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Riprazo HCT.
English: EPAR summary for the public aliskiren / hydrochlorothiazide
Danish: EPAR - sammendrag for offentligheden aliskiren/hydrochlorthiazid
English: The dose depends on the doses of aliskiren and/or hydrochlorothiazide that the patient was taking before.
Danish: Dosis afhænger af de doser aliskiren og/eller hydrochlorthiazid, som patienten har taget tidligere.
English: It must not be taken with ciclosporin, itraconazole or other medicines known as ‘potent P-glycoprotein inhibitors' (such as quinidine).
Danish: Det må ikke anvendes sammen med ciclosporin, itraconazol eller andre såkaldte “potente Pglykoproteinhæmmere” (såsom kinidin).
English: The studies compared the combination of aliskiren and hydrochlorothiazide with placebo (a dummy treatment), with aliskiren or hydrochlorothiazide taken alone, or with other medicines for hypertension (valsartan, irbesartan, lisinopril or amlodipine).
Danish: I undersøgelserne sammenlignede man kombinationen af aliskiren og hydrochlorthiazid med placebo (en virkningsløs behandling), med aliskiren eller hydrochlorthiazid anvendt alene eller med andre lægemidler mod hypertension (valsartan, irbesartan, lisinopril eller amlodipin).
English: For the full list of all side effects reported with Riprazo HCT, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Riprazo HCT fremgår af indlægssedlen.
English: Riprazo HCT must not be used in people who are hypersensitive (allergic) to aliskiren, hydrochlorothiazide, any of the other ingredients or sulfonamides.
Danish: Riprazo HCT må ikke anvendes hos personer, der er overfølsomme (allergiske) over for aliskiren, hydrochlorthiazid, nogen af de øvrige indholdsstoffer eller sulfonamider.
English: By lowering blood pressure, the risk caused by high blood pressure, such as having a stroke, is reduced.
Danish: Ved at sænke blodtrykket reduceres risikoen for skader på grund af for højt blodtryk, såsom slagtilfælde.
English: Riprazo HCT is used in patients whose blood pressure is not adequately controlled by aliskiren or hydrochlorothiazide taken alone.
Danish: Riprazo HCT anvendes til patienter, hvis blodtryk ikke kan kontrolleres tilstrækkeligt med aliskiren eller hydrochlorthiazid alene.
English: In patients already adequately controlled with the two active substances, the dose of Riprazo HCT must contain the same doses of aliskiren and hydrochlorothiazide that the patient was taking before.
Danish: Hos patienter, som allerede kontrolleres tilstrækkeligt med de to aktive stoffer, skal dosis af Riprazo HCT indeholde de samme doser aliskiren og hydrochlorthiazid, som patienten har taget tidligere.
English: Patients previously taking only aliskiren or hydrochlorothiazide may need to take the two substances as separate tablets and adjust the doses before switching to Riprazo HCT.
Danish: Patienter, som tidligere har taget aliskiren eller hydrochlorthiazid alene, kan være nødt til at tage de to stoffer som separate tabletter og tilpasse dosis, før de skifter til Riprazo HCT.
English: It can also be used in patients whose blood pressure is adequately controlled with aliskiren and hydrochlorothiazide taken as separate tablets, to replace the same doses of the two active substances.
Danish: Det kan ligeledes anvendes til patienter, hvis blodtryk kontrolleres tilstrækkeligt med aliskiren og hydrochlorthiazid taget som separate tabletter for at erstatte de samme doser af de to aktive stoffer.
English: In patients whose blood pressure was not adequately controlled on either aliskiren or hydrochlorothiazide alone, switching to the combination resulted in greater falls in blood pressure than remaining on one active substance alone.
Danish: Hos patienter, hvis blodtryk ikke var tilstrækkeligt kontrolleret med enten aliskiren eller hydrochlorthiazid alene, resulterede overgangen til kombinationen i et større fald i blodtrykket end den fortsatte anvendelse af et aktivt stof alene.
English: Riprazo HCT contains two active substances, aliskiren and hydrochlorothiazide.
Danish: Riprazo HCT indeholder to aktive stoffer, aliskiren og hydrochlorthiazid.
English: Riprazo HCT in combination with an ‘angiotensin converting enzyme (ACE) inhibitors' or ‘angiotensin receptor blockers' (ARBs) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Danish: Riprazo HCT i kombination med “angiotensinkonvertasehæmmere” (“ACE-hæmmere”) eller “angiotensinreceptorantagonister” (ARB) må ikke anvendes hos patienter med sukkersyge eller moderat til svært nedsat nyrefunktion.
English: Riprazo HCT is a medicine that contains the active substances aliskiren and hydrochlorothiazide.
Danish: Riprazo HCT er et lægemiddel, der indeholder de aktive stoffer aliskiren og hydrochlorthiazid.
English: It must not be used in patients who have had angioedema (swelling under the skin) with aliskiren, hereditary angioedema or angioedema of no obvious cause, who have severe kidney or liver impairment, or whose blood potassium levels are too low or blood calcium levels are too high.
Danish: Det må ikke anvendes hos patienter, der har fået angioødem (hævelse under huden) ved behandling med aliskiren, patienter med arveligt angioødem eller angioødem uden kendt årsag, patienter med svær nyre- eller leverfunktionsnedsættelse eller patienter med for lavt kaliumindhold eller for højt kalciumindhold i blodet.
English: What is the risk associated with Riprazo HCT?
Danish: Hvilken risiko er der forbundet med Riprazo HCT?
English: Why has Riprazo HCT been approved?
Danish: Hvorfor blev Riprazo HCT godkendt?
English: It blocks the activity of a human enzyme called renin, which is involved in the production of a substance called angiotensin I in the body.
Danish: Det blokerer virkningen af et humant enzym kaldet renin, der i kroppen medvirker ved dannelsen af stoffet angiotensin I. Angiotensin I omdannes til hormonet angiotensin II, som er en kraftig vasokonstriktor (et stof, der forsnævrer blodkarrene).
English: How has Riprazo HCT been studied?
Danish: Hvordan blev Riprazo HCT undersøgt?
English: What is Riprazo HCT?
Danish: Hvad er Riprazo HCT?
English: What benefit has Riprazo HCT shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Riprazo HCT?
English: What is Riprazo HCT used for?
Danish: Hvad anvendes Riprazo HCT til?
English: How is Riprazo HCT used?
Danish: Hvordan anvendes Riprazo HCT?
English: How does Riprazo HCT work?
Danish: Hvordan virker Riprazo HCT?
English: Repeat this action vigorously for at least 15 seconds.
Danish: Gentag omhyggeligt denne handling i mindst 15 sekunder.
English: Vaccination is the best way to protect against these diseases.
Danish: Vaccination er den bedste måde at beskytte sig mod disse sygdomme.
English: The severity and type of symptoms can vary.
Danish: Sværhedsgraden og arten af symptomerne kan variere.
English: • you have a severe infection with a high temperature (over 38°C).
Danish: • du har en alvorlig infektion med høj feber (over 38 °C).
English: Hold the syringe upright in a closed hand.
Danish: Hold sprøjten lodret i en lukket hånd.
English: Side effects that may occur are the following:
Danish: Følgende bivirkninger kan forekomme:
English: A minor infection such as a cold should not be a problem, but talk to your doctor first.
Danish: En lettere infektion såsom forkølelse er normalt ikke noget problem, men tal med din læge om det først.
English: Most people recover completely but the illness is usually severe enough to keep people ill for about a month.
Danish: De fleste personer kommer sig fuldstændigt efter sygdommen, som dog almindeligvis er så alvorlig, at man er syg i ca. en måned.
English: Turbid white suspension.
Danish: Uklar hvid suspension.
English: Each injection is given on a separate visit.
Danish: Hver injektion gives ved separate lægebesøg.
English: Such reactions may occur before leaving the doctor's surgery.
Danish: De nævnte reaktioner kan optræde, inden du forlader lægens klinik.
English: This schedule may be given to adults only needing a rapid protection (e.g. overseas travellers).
Danish: Dette vaccinationsprogram må kun gives til voksne, som har behov for hurtig beskyttelse (f.eks. oversøisk rejsende).
English: EXPIRY DATE EXP: MM/YYYY
Danish: UDLØBSDATO EXP: MM/YYYY
English: Cases of overdose have been reported during post-marketing surveillance.
Danish: Der er set tilfælde af overdosering i forbindelse med overvågning efter markedsføring.
English: Stinging and burning sensation
Danish: Sviende og brændende fornemmelse
English: Shake the syringe by tipping it upside down and back again.
Danish: Ryst sprøjten ved at vende den på hovedet og tilbage igen.
English: The vaccine should be re-suspended before use.
Danish: Vaccinen skal resuspenderes inden brug.
English: You will receive a total of three injections over 6 months.
Danish: Du vil få i alt tre injektioner i løbet af 6 måneder.
English: None of the components in the vaccine are infectious.
Danish: Ingen af stofferne i vaccinen er smitsomme.
English: Guidelines for boosting are based on the assumption that antibodies are required for protection; anti-HAV antibodies have been predicted to persist for at least 10 years.
Danish: Vejledning om boosting er baseret på antagelsen om, at antistoffer er nødvendige for beskyttelse; anti-HAV-antistoffer forudses at kunne persistere i mindst 10 år.
English: If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this vaccine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du får denne vaccine.
English: Read all of this leaflet carefully before you start receiving this vaccine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du får vaccinen, da den indeholder vigtige oplysninger.
English: Non-clinical data reveal no special hazard for humans based on general safety studies.
Danish: Prækliniske data viste ikke nogen specifikke humane risikofaktorer baseret på generelle sikkerhedsstudier.
English: Symptoms of hepatitis A begin 3 to 6 weeks after coming into contact with the virus.
Danish: Symptomer på hepatitis A begynder 3 til 6 uger efter, at man har været i kontakt med virus.
English: • you are allergic to: - the active substances or any of the other ingredients of this medicine (listed in section 6).
Danish: • du er allergisk over for: - et af de aktive stoffer eller et af de øvrige indholdsstoffer i vaccinen (angivet i punkt 6).
English: Protection against hepatitis A and hepatitis B develops within 2-4 weeks.
Danish: Beskyttelse mod hepatitis A og hepatitis B udvikles indenfor 2-4 uger.
English: A dose of 1.0 ml is recommended for adults and adolescents 16 years of age and above.
Danish: En dosis på 1,0 ml anbefales til voksne og unge på 16 år og derover.
English: b. If the vaccine still does not appear as a uniform hazy white suspension - tip upside down and back again for at least another 15 seconds - then inspect again.
Danish: b. Hvis vaccinen stadig ikke fremstår som en ensartet, uklar hvid suspension - vend den på hovedet og tilbage igen i yderligere mindst 15 sekunder - inspicer derefter igen.
English: The first dose will be given on an elected date.
Danish: Den første vaccinedosis gives på en udvalgt dato.
English: After a few days the whites of eyes and skin may become yellowish (jaundice).
Danish: Efter få dage kan huden og det hvide i øjnene blive gullig (gulsot).
English: The vaccine may contain traces of neomycin which is used during the manufacturing process (see section 4.3).
Danish: Vaccinen kan indeholde spormængder af neomycin, som anvendes under fremstillingsprocessen (se pkt.
English: Hepatitis B surface antigen3,4
Danish: Hepatitis B-overfladeantigen3,4
English: Post-marketing surveillance
Danish: Overvågning efter markedsføring
English: Young children may not develop jaundice.
Danish: Små børn udvikler ikke altid gulsot.
English: The 0, 7 and 21 day primary schedule plus a fourth dose at month 12 is for use in exceptional circumstances in adults.
Danish: Det primære program på dag 0, 7 og 21 plus en fjerde dosis ved 12. måned, er kun til anvendelse i specielle situationer hos voksne.
English: The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Danish: Vaccinen skal inspiceres visuelt for fremmede partikler og/eller ændringer i det fysiske udseende før administration.
English: - Primary vaccination schedule
Danish: - Primært vaccinationsprogram
English: These factors include older age, male gender, obesity, smoking, route of administration, and some chronic underlying diseases.
Danish: Disse faktorer omfatter alder, mandligt køn, overvægt, rygning, administrationsmåde og visse kroniske sygdomme.
English: • you have a poor immune system due to illness or drug treatment.
Danish: • du har nedsat immunforsvar på grund af en sygdom eller som følge af behandling med medicin.
English: General guidelines for booster vaccination can therefore be drawn from experience with the monovalent vaccines.
Danish: Generelle retningslinjer for boostervaccination kan derfor overføres fra erfaringerne med de monovalente vacciner.
English: EU/1/96/020/001 - pack of 1 without needle EU/1/96/020/002 - pack of 10 without needle EU/1/96/020/003 - pack of 25 without needle EU/1/96/020/007 - pack of 1 with 1 needle EU/1/96/020/008 - pack of 10 with 10 needles EU/1/96/020/009 - pack of 25 with 25 needles
Danish: EU/1/96/020/001 - pakning med 1 uden kanyle EU/1/96/020/002 - pakning med 10 uden kanyler EU/1/96/020/003 - pakning med 25 uden kanyler EU/1/96/020/007 - pakning med 1 med 1 kanyle EU/1/96/020/008 - pakning med 10 med 10 kanyler EU/1/96/020/009 - pakning med 25 med 25 kanyler
English: Long-term antibody persistence data following vaccination with Twinrix Adult are available up to 15 years after vaccination.
Danish: Data vedrørende antistoftilstedeværelsen på langt sigt efter vaccination med Twinrix Voksen er tilgængelige i op til 15 år efter vaccination.
English: Pack sizes of 1, 10 and 25 with or without needles.
Danish: Pakningsstørrelse på 1, 10 og 25 med eller uden kanyle.
English: However, this route of administration may result in suboptimal immune response to the vaccine (see section 4.4).
Danish: Denne administrationsvej kan imidlertid medføre et suboptimalt immunrespons over for vaccinen (se pkt.
English: The doctor will give Twinrix Adult as an injection into your upper arm muscle.
Danish: Lægen vil give Twinrix Voksen som en injektion i din muskel i overarmen.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Danish: Som ved alle injicérbare vacciner skal passende medicinsk behandling og overvågning altid være let tilgængelig i tilfælde af en sjælden anafylaktisk reaktion som følge af administrationen af vaccinen.
English: In situations where a booster dose of both hepatitis A and hepatitis B are desired, Twinrix Adult can be given.
Danish: I situationer, hvor en boosterdosis af både hepatitis A og hepatitis B ønskes, kan Twinrix Voksen gives.
English: Pharmaco-therapeutic group: Hepatitis vaccines, ATC code: J07BC20.
Danish: Farmakoterapeutisk klassifikation: Hepatitis-vacciner ATC-kode: J07BC20
English: Twinrix Adult has no or negligible influence on the ability to drive and use machines.
Danish: Twinrix Voksen har ingen eller ubetydelig indflydelse på evnen til at føre motorkøretøj og betjene maskiner.
English: • Hepatitis B: Hepatitis B is caused by the hepatitis B virus.
Danish: • Hepatitis B: Hepatitis B er forårsaget af hepatitis B-virus.
English: This study did not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/fetal development, parturition or post-natal development.
Danish: Studiet viste ingen direkte eller indirekte skadelige virkninger på fertilitet, graviditet, på fosterudviklingen, på parturition eller den postnatale udvikling.
English: Although the concomitant administration of Twinrix Adult and other vaccines has not specifically been studied, it is anticipated that, if different syringes and other injection sites are used, no interaction will be observed.
Danish: Skønt samtidig administration af Twinrix Voksen og andre vacciner ikke er specifikt undersøgt, antages det, at hvis forskellige sprøjter og andre injektionssteder anvendes, vil der ikke observeres nogen interaktion.
English: Subjects received an additional dose of the same vaccine(s) 48 months after the first dose of the primary vaccination course.
Danish: Nogle personer fik yderligere en dosis af den/de samme vaccine(r) 48 måneder efter den første dosis i det primære vaccinationsprogram.
English: Abnormal liver function tests * refers to adverse reactions observed in clinical trials performed with the paediatric formulation
Danish: Unormale leverfunktionstest * henviser til bivirkninger set i kliniske studier udført med den pædiatriske formulering.
English: The vaccine should never be given into a vein.
Danish: Vaccinen må aldrig gives direkte ind i en blodåre.
English: The kinetics of antibody decline are also similar.
Danish: Kinetikforholdene vedrørende nedgangen i antistofferne er også lig hinanden.
English: One month after the fourth dose, all vaccinees demonstrated seroprotective levels of anti-HBs antibodies and were seropositive for anti-HAV antibodies.
Danish: En måned efter den fjerde dosis viste alle vaccinerede beskyttende niveauer af anti-HB-antistoffer og var sero-positive for anti-HAV-antistoffer.
English: The administration of Twinrix Adult should be postponed in subjects suffering from acute severe febrile illness.
Danish: Administration af Twinrix Voksen skal udskydes hos personer, der lider af akut alvorlig febril sygdom.
English: Since intradermal injection or intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, these routes should be avoided.
Danish: Da intradermal injektion eller intramuskulær administration i glutealregionen kan føre til et suboptimalt respons overfor vaccinen, skal disse administrationsveje undgås.
English: The vaccine will not prevent infection caused by other agents such as hepatitis C and hepatitis E and other pathogens known to infect the liver.
Danish: Vaccinen forebygger ikke infektion forårsaget af andre agentia såsom hepatitis C og hepatitis E eller andre patogene organismer, som vides at inficere leveren.
English: • Hepatitis A: Hepatitis A is an infectious disease, which can affect the liver.
Danish: • Hepatitis A: Hepatitis A er en smitsom sygdom, der kan angribe leveren.
English: It is not known whether Twinrix Adult will prevent hepatitis A and hepatitis B in such cases.
Danish: Det vides ikke, om Twinrix Voksen vil forebygge hepatitis A og hepatitis B i sådanne tilfælde.
English: The vaccine has not been tested in patients with impaired immunity.
Danish: Vaccinen er ikke testet i patienter med svækket immunsystem.
English: Gastrointestinal symptoms, diarrhoea, nausea
Danish: Almindelig Gastrointestinale symptomer, diarré, kvalme
English: The standard primary course of vaccination with Twinrix Adult consists of three doses, the first administered at the elected date, the second one month later and the third six months after the first dose.
Danish: Standardvaccinationsprogrammet for primær vaccination med Twinrix Voksen består af tre doser, den første administreres på en udvalgt dato, den anden en måned senere og den tredje seks måneder efter den første dosis.
English: The hepatitis A virus can be passed from person to person in food and drink, or by swimming in water contaminated by sewage.
Danish: Hepatitis A-virus kan overføres fra person til person via mad og drikke eller ved badning i vand, som er forurenet med spildevand.
English: The need for a booster dose of hepatitis B vaccine in healthy individuals who have received a full primary vaccination course has not been established; however some official vaccination programmes currently include a recommendation for a booster dose of hepatitis B vaccine and these should be respected.
Danish: Behovet for en boosterdosis med hepatitis B-vaccine hos raske personer, som har modtaget et fuldt primært vaccinationsprogram, er ikke blevet fastlagt; dog indeholder flere officielle vaccinationsprogrammer for tiden en rekommendation af en boosterdosis af hepatitis B-vaccine, hvilket skal respekteres.
English: After a fourth dose given at month 12, the incidence of systemic and local adverse reactions was comparable to that seen after vaccination at 0, 7, 21 days.
Danish: Efter den fjerde dosis administreret i 12. måned var forekomsten af systemiske og lokale bivirkninger sammenlignelig med, hvad der blev set efter vaccination på dag 0, 7 og 21.
English: However, if you get any of these symptoms you should contact a doctor urgently.
Danish: Hvis du får nogle af disse symptomer, skal du straks kontakte lægen.
English: The HA virus is propagated in MRC5 human diploid cells.
Danish: HA-virus har formeret sig i MRC5 humane diploide celler.
English: • you have experienced any health problems after previous administration of a vaccine.
Danish: • du tidligere har haft helbredsproblemer efter at være blevet vaccineret.