FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the following side effects are seen in between 1 and 10 patients in 1,000: upper respiratory tract infection (colds) including inflammation of the throat and sinuses, urinary tract infection (infection of the structures that carry urine) including bladder infection, anaemia (low red blood cell counts), hyperkalaemia (high blood potassium levels), depression, insomnia (difficulty sleeping), syncope (fainting), vertigo (a spinning sensation), bradycardia (slow heart rate), hypotension (low blood pressure), dyspnoea (difficulty breathing), cough, abdominal pain (stomach ache), diarrhoea, dyspepsia (heartburn), flatulence (gas), vomiting, hyperhidrosis (excessive sweating), pruritus (itching), rash, myalgia (muscle pain), back pain, muscle spasms, renal impairment (reduced kidney function) including sudden kidney failure, chest pain, asthenia (weakness) and increased blood levels of creatinine (a marker of muscle breakdown).
Danish: svimmelhed, bradykardi (langsom hjerterytme), hypotension (lavt blodtryk), dyspnø (vejrtrækningsbesvær), hoste, mavesmerter, diarré, dyspepsi (halsbrand), flatulens (luft i maven), opkastning, hyperhidrose (forøget svedafsondring), kløe, udslæt, myalgi (muskelsmerter), rygsmerter, muskeltrækninger, nyreproblemer (nedsat nyrefunktion), herunder pludselig nyresvigt, brystsmerter, asteni (kraftesløshed) og øget indhold af kreatinin i blodet (en markør for muskelnedbrydning).
English: In the treatment of essential hypertension, Micardis was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Danish: Til behandling af essentiel hypertension var Micardis mere effektivt end placebo til at nedsætte det diastoliske blodtryk, og virkningerne af Micardis svarede til virkningerne af andre lægemidler mod forhøjet blodtryk.
English: Patients with severely reduced kidney function should receive a lower starting dose of 20 mg once a day.
Danish: Patienter med svært nedsat nyrefunktion bør få en lavere startdosis på 20 mg én gang dagligt.
English: In the prevention of cardiovascular problems, Micardis had a similar effect to ramipril, with around 17% of patients dying, being admitted to hospital because of cardiovascular problems, or having a heart attack or stroke.
Danish: Til forebyggelse af kardiovaskulære problemer svarede virkningen af Micardis til virkningen af ramipril, idet ca. 17 % af patienterne døde, blev hospitalsindlagt som følge af kardiovaskulære problemer eller fik et hjerteanfald eller slagtilfælde.
English: What is Micardis?
Danish: Hvad er Micardis?
English: Side effects with Micardis are not common.
Danish: Normalt er der ikke bivirkninger ved Micardis.
English: For the full list of all side effects reported with Micardis, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Micardis fremgår af indlægssedlen.
English: Patients with mild or moderately reduced liver function should not receive doses higher than 40 mg a day.
Danish: Patienter med mild eller moderat nedsat leverfunktion bør højst få 40 mg dagligt.
English: If the target blood pressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
Danish: Ved utilstrækkelig virkning kan dosis øges til 80 mg, eller Micardis kan anvendes i kombination med et andet lægemiddel for hypertension, for eksempel hydrochlorothiazid.
English: The full EPAR for Micardis is available on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Micardis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Hvis du ønsker yderligere oplysninger om behandling med Micardis, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What is Micardis used for?
Danish: Hvad anvendes Micardis til?
English: What benefit has Micardis shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Micardis?
English: How has Micardis been studied?
Danish: Hvordan blev Micardis undersøgt?
English: How is Micardis used?
Danish: Hvordan anvendes Micardis?
English: How does Micardis work?
Danish: Hvordan virker Micardis?
English: This summary was last updated in 07-2013.
Danish: Dette sammendrag blev sidst ajourført i 07-2013.
English: The body is able to remove this salt from the cells.
Danish: Kroppen er i stand til at fjerne denne salt fra cellerne.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cystagon on 23 June 1997.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cystagon den 23. juni 1997.
English: It is available as capsules (50 and 150 mg).
Danish: Det fås som kapsler (50 og 150 mg).
English: It should also not be used in women who are breastfeeding, or who are pregnant (particularly during the first three months) unless it is clearly necessary.
Danish: Det må heller ikke anvendes hos kvinder, der ammer, eller som er gravide (især i løbet af de første tre måneder), medmindre dette er absolut nødvendigt.
English: The maximum dose should never exceed 1.95 g per m2 per day.
Danish: Maksimaldosen bør aldrig overstige 1,95 g per m2 per dag.
English: This is a summary of the European public assessment report (EPAR) for Cystagon.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cystagon.
English: The full EPAR for Cystagon can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Cystagon findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It also improves survival and growth rate in the children treated.
Danish: Det forbedrer også overlevelsesprocenten og væksten hos de børn, der blev behandlet.
English: The starting dose should be increased gradually over 4 to 6 weeks.
Danish: Startdosis bør øges gradvist over 4-6 uger.
English: The amount of cystine in the organs is therefore reduced, and this limits the damage to these organs.
Danish: Mængden af cystin i organerne mindskes således, hvilket begrænser skaden på disse organer.
English: Starting doses should be one quarter to one sixth of the final expected doses.
Danish: Startdoser bør være på mellem en sjettedel og en fjerdedel af de endeligt forventede doser.
English: Cystagon has been investigated in three main studies including 234 patients over a 12-year period.
Danish: Cystagon er blevet analyseret i tre hovedundersøgelser, der omfattede 234 patienter over en 12-årig periode.
English: The three studies showed that Cystagon delays kidney problems and the need for dialysis or renal transplantation, when treatment is started at an early age.
Danish: De tre undersøgelser viste, at Cystagon forsinker nyreproblemer og behovet for dialyse eller nyretransplantation, når behandlingen påbegyndes i en tidlig alder.
English: Because the disease is very serious, it was not possible for ethical reasons to compare Cystagon directly to placebo (a dummy treatment).
Danish: Da sygdommen er meget alvorlig, var det af etiske grunde ikke muligt at fortage en direkte sammenligning mellem Cystagon og placebo (en uvirksom behandling).
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 Cystagon.
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 Cystagon.
English: Cystine levels in white blood cells should be monitored and used to adjust the dose.
Danish: Cystinniveauet i de hvide blodceller bør overvåges for at bestemme den nødvendige dosering.
English: The comparison was done instead with a group of patients who had been treated with a dummy treatment as part of another, unrelated trial.
Danish: Sammenligningen blev i stedet foretaget med en anden gruppe patienter, som havde modtaget en placebobehandling som del af en anden, ikke-tilknyttet undersøgelse.
English: For patients over the age of 12 and over 50 kg in weight, the recommended daily dose is 2 g divided into 4 doses.
Danish: For patienter over 12 år, som vejer mere end 50 kg, er den anbefalede daglige dosis 2 g fordelt på 4 doser.
English: The studies looked at the kidney function, the survival and the growth rate of the patients.
Danish: I undersøgelserne blev der fokuseret på nyrefunktionen, overlevelsesprocenten og væksten hos patienterne.
English: The CHMP decided that Cystagon's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Cystagon opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: For more information about treatment with Cystagon, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Cystagon, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: These studies included children and newly recruited patients in whom two different doses were tested.
Danish: Undersøgelserne omfattede børn og nyligt indkaldte patienter, som modtog to forskellige doser.
English: Cystagon treatment should be started by a doctor who has experience in the treatment of cystinosis.
Danish: Behandling med Cystagon bør påbegyndes af en læge med erfaring i behandling af cystinose.
English: Other information about Cystagon
Danish: Andre oplysninger om Cystagon:
English: For children up to the age of 12 years, the recommended daily dose is calculated according to body surface area (which is calculated from the patient's height and weight), as 1.30 g per m2 divided into 4 doses.
Danish: For børn under 12 år beregnes den anbefalede daglige dosis ud fra legemsoverfladen (dvs. patientens højde og vægt), som 1,30 g per m2 fordelt på 4 doser.
English: Cystagon is a medicine containing the active substance mercaptamine (also known as cysteamine).
Danish: Cystagon er et lægemiddel, der indeholder det aktive stof mercaptamine (også kendt som cysteamin).
English: Cystinosis is a rare, fatal disease, and Cystagon is considered a useful medicine for this disease.
Danish: Cystanose er en meget sjælden og livstruende sygdom, og Cystagon anses for at være et brugbart lægemiddel mod denne sygdom.
English: Cystagon must not be used in people who are hypersensitive (allergic) to cysteamine or any of the other ingredients, or to another medicine called penicillamine.
Danish: Cystagon må ikke anvendes hos personer, som er overfølsomme (allergiske) over for cysteamin, andre af indholdsstofferne eller et andet lægemiddel, som kaldes penicillamin.
English: Cystinosis is a rare inherited disease in which excess amounts of cystine, an amino acid naturally found in the body, build up within cells, especially in the kidneys and the eyes, damaging them.
Danish: Cystinose er en sjælden, arvelig sygdom, ved hvilken der ophobes cystin (en aminosyre, der findes naturligt i kroppen) i kroppens celler, især i nyrene og øjnene, hvorved cellerne beskadiges.
English: The most common side effects with Cystagon (seen in more than 1 patient in 10) are loss of appetite, vomiting, nausea (feeling sick), diarrhoea, lethargy (lack of energy) and pyrexia (fever).
Danish: De mest almindelige bivirkninger ved Cystagon (som ses hos flere end 1 ud af 10 patienter) er appetitløshed, kvalme, opkastning, diarré, udmattelse og feber.
English: For the full list of all side effects reported with Cystagon, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Cystagon fremgår af indlægssedlen.
English: The active substance in Cystagon, mercaptamine, reacts with cystine to form another amino acid, called cysteine, and a compound called a cysteine-cysteamine salt.
Danish: Det aktive stof i Cystagon, mercaptamin, reagerer med cystin og danner en ny aminosyre kaldet cystein, og en forbindelse, der kaldes en cystein-cysteaminsalt.
English: What is the risk associated with Cystagon?
Danish: Hvilken risiko er der forbundet med Cystagon?
English: Why has Cystagon been approved?
Danish: Hvorfor blev Cystagon godkendt?
English: What is Cystagon?
Danish: Hvad er Cystagon?
English: What is Cystagon used for?
Danish: Hvad anvendes Cystagon til?
English: What benefit has Cystagon shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Cystagon?
English: How has Cystagon been studied?
Danish: Hvordan blev Cystagon undersøgt?
English: How is Cystagon used?
Danish: Hvordan anvendes Cystagon?
English: Cystagon is used in patients who have nephropathic (kidney) cystinosis.
Danish: Cystagon anvendes til behandling af patienter, som lider af nefropatisk cystinose.
English: How does Cystagon work?
Danish: Hvordan virker Cystagon?
English: In such cases, the Western Blot method is negative.
Danish: I disse tilfælde er Western Blot metoden negativ.
English: A-2304 Orth/Donau Austria
Danish: A-2304 Orth/Donau Østrig
English: • you have a severe infection with a high temperature (over 38 °C).
Danish: • hvis du har en kraftig infektion med høj temperatur (over 38 °C).
English: CZ-281 63 Kostelec nad Cernymi lesy Czech Republic
Danish: CZ-281 63 Kostelec nad Cernymi lesy
English: Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.
Danish: Fortæl det til din læge, hvis du er gravid, tror du måske er gravid, eller planlægger at få et barn.
English: No case of overdose has been reported.
Danish: Der er ikke rapporteret tilfælde af overdosering.
English: If this applies to you then your vaccination will usually be postponed until you are feeling better.
Danish: Er dette tilfældet, vil din vaccination som regel blive udsat, indtil du har det bedre.
English: In the first few weeks after vaccination with Celvapan the results of these tests may not be correct.
Danish: I de første par uger efter vaccination med Celvapan er resultaterne af disse analyser muligvis ikke korrekte.
English: Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du får vaccinen, da den indeholder vigtige oplysninger.
English: Preferred MedDRA Term
Danish: Foretrukket MedDRA-term
English: These transitory false-positive results may be due to IgM production in response to the vaccine.
Danish: Disse forbigående falsk positive resultater kan skyldes IgM produktion som respons på vaccinen.
English: In accordance with Article 114 Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Danish: I henhold til artikel 114 i direktiv 2001/83/EC foretages den officielle batchfrigivelse af et statsligt laboratorium eller et laboratorium udpeget hertil.
English: Results from Vaccine Effectiveness Study in Jersey
Danish: Resultater af vaccineeffektivitetsstudie på Jersey
English: This is because the vaccination may not be recommended, or may need to be delayed.
Danish: Det skyldes, at vaccination muligvis frarådes eller bør udsættes.
English: Do not use Celvapan after the expiry date which is stated on the carton.
Danish: Brug ikke Celvapan efter den udløbsdato, der står på pakningen.
English: The use of Celvapan may be considered during pregnancy if this is thought to be necessary, taking into
Danish: Brug af Celvapan kan overvejes under graviditet, hvis det skønnes nødvendigt, og under hensyntagen
English: It should be noted that the adverse reactions may be intensified.
Danish: Det skal bemærkes, at bivirkningsreaktionerne kan forværres.
English: Shake before use.
Danish: Omrystes før brug.
English: However, some differences in frequency and type of side effects were observed.
Danish: Der var dog visse forskelle med hensyn til hyppigheden og typen af bivirkninger.
English: • you have problems with your immune system, since your response to the vaccine may then be poor.
Danish: • hvis du har problemer med dit immunforsvar, da din respons på vaccinen så kan være dårlig.
English: Day 361
Danish: Dag 361
English: Such reactions have occurred both in patients with a history of multiple allergies and in patients with no known allergy.
Danish: Sådanne reaktioner er forekommet både hos patienter, der tidligere har haft multiple allergier, og hos patienter uden kendt allergi.
English: The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Danish: Det immunologiske respons kan nedsættes, hvis patienten er i immunsupprimerende behandling.
English: Tell the doctor requesting these tests that you have recently been given Celvapan.
Danish: Fortæl den læge, der ønsker disse analyser, at du for nylig har fået Celvapan.
English: 21 Days After
Danish: Efter 21 dage
English: There were no reported vaccine failures in either of these paediatric age groups.
Danish: Der var ingen rapporterede vaccinesvigt i disse to pædiatriske aldersgrupper.
English: “Possible side effects” may affect your ability to drive or use
Danish: ”Bivirkninger” kan påvirke din evne til at køre bil og til at arbejde
English: A minor infection such as a cold should not be problem, but your doctor or nurse should advise whether you could still be vaccinated with Celvapan.
Danish: En mindre infektion som en forkølelse bør ikke være noget problem, men din læge eller sygeplejerske bør vejlede dig med hensyn til, om du stadig bør vaccineres med Celvapan,
English: Day 181
Danish: Dag 181
English: Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB01
Danish: Farmakoterapeutisk klassifikation: Influenzavacciner, ATC-kode J07BB01
English: The frequency of these adverse reactions is not known.
Danish: Hyppigheden af disse bivirkninger er ukendt.
English: There were fewer reactions after the second dose of the vaccine compared with the first dose.
Danish: Der var færre bivirkninger efter den anden dosis af vaccinen end efter den første dosis.
English: • you are having a blood test to look for evidence of infection with certain viruses.
Danish: • hvis du skal have taget en blodprøve for at se efter tegn på infektion med visse vira.
English: None of the ingredients in the vaccine can
Danish: Ingen af indholdsstofferne i vaccinen kan forårsage
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/.
Danish: Yderligere oplysninger om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs (EMAs) hjemmeside http://www.ema.europa.eu.
English: • Safety and immunogenicity data in healthy adults, including older people.
Danish: • Sikkerheds- og immunogenicitetsdata hos raske voksne, inklusive ældre.
English: The safety of Celvapan in pregnancy and lactation has been assessed in a limited number of pregnant
Danish: Celvapans sikkerhed under graviditet og amning er blevet vurderet hos et begrænset antal kvinder.
English: Pain in arms and or legs (in the majority of cases reported as pain in the vaccination arm)
Danish: Smerter i arme og/eller ben (i de fleste tilfælde indberettet som smerter i den vaccinerede arm)
English: The other ingredients are: trometamol, sodium chloride, water for injections, polysorbate 80.
Danish: De øvrige indholdsstoffer er: Trometamol, natriumchlorid, vand til injektionsvæsker, polysorbat 80.
English: Your doctor or nurse will administer the vaccine in accordance with official recommendations.
Danish: En læge eller sygeplejerske vil give dig vaccinen i henhold til de officielle retningslinjer.
English: The vaccine will be injected into a muscle (usually in the upper arm).
Danish: Vaccinen bliver indsprøjtet i en muskel (oftest i overarmen).
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF
English: Immunisation shall be postponed in patients with severe febrile illness or acute infection.
Danish: Immuniseringen af patienter med alvorlig febril sygdom eller akut infektion skal udsættes.
English: Pharyngolaryngeal pain
Danish: Faryngolaryngeale smerter
English: Your doctors know that this might happen and will have emergency treatment ready to use.
Danish: Din læge ved, at dette kan forekomme og vil have nødbehandling klar.
English: However, chemical and physical in-use stability has been demonstrated for 3 hours at room temperature.
Danish: Der er påvist en kemisk og fysisk holdbarhed i op til 3 timer ved stuetemperatur.
English: Children aged less than 6 months Vaccination is not currently recommended in this age group.
Danish: Børn yngre end 6 måneder På nuværende tidspunkt anbefales vaccination ikke til denne aldersgruppe.
English: • Side effects observed with flu vaccines given routinely every year The side effects listed below have occurred in the days or weeks after vaccination with vaccines given routinely every year to prevent flu.
Danish: • Bivirkninger set under rutinemæssig influenzavaccination, der gives hvert år Bivirkninger anført nedenfor er forekommet i dagene eller ugerne efter vaccination med influenzavacciner, der rutinemæssigt gives hvert år for at forebygge influenza.
English: Allergic reactions may occur following vaccination, in rare cases leading to shock.
Danish: Der kan opstå allergiske reaktioner efter vaccinationen, som i sjældne tilfælde kan føre til shock.
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 andre injicerbare vacciner bør passende medicinsk behandling og overvågning altid være til stede i tilfælde af sjælden anafylaktisk reaktion ved indgift af vaccinen.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med
English: • Safety and immunogenicity data obtained three weeks after administration of two doses of
Danish: • Sikkerheds- og immunogenicitetsdata opnået tre uger efter indgivelse af to doser Celvapan
English: This is a multidose container.
Danish: Dette er en beholder med flere doser.
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen er den sidste dag i den
English: ADR frequency is based upon the following scale: Very Common (≥ 1/10); Common (≥ 1/100< 1/10), Uncommon (≥ 1/1,000 - < 1/100), Rare (≥ 1/10,000 - < 1/1,000), Very Rare (< 1/10,000)
Danish: Bivirkningshyppigheden refererer til følgende skala: Meget almindelig (≥1/10); Almindelig (≥1/100 til <1/10), Ikke almindelig (≥1/1.000 til <1/100), Sjælden (≥1/10.000 til <1/1.000),
English: • The correct way to prepare the vaccine prior to administration.
Danish: • Korrekt håndtering af vaccinen før indgivelse.
English: After first opening, the product should be used immediately.
Danish: Produktet bør anvendes omgående efter første åbning.
English: Such alterations in liver function have not been seen to date in human clinical studies.
Danish: Sådanne forandringer i leverfunktionen er til dato ikke iagttaget i kliniske studier med mennesker.
English: Safety data after the first and second vaccination suggest a similar safety profile to that reported for the influenza vaccines
Danish: Sikkerhedsdata efter første og anden vaccination antyder en sikkerhedsprofil, der svarer til den, der blev rapporteret for influenzavacciner baseret på en
English: Vaccination is not currently recommended in this age group.
Danish: På nuværende tidspunkt anbefales vaccination ikke til denne aldersgruppe.
English: In the clinical studies, most side effects were mild in nature and short term.
Danish: I de kliniske studier var de fleste bivirkninger lette og kortvarige.