FrancophonIA/ELRC3.0 huggingface dataset:
English: Hexavac is a hexavalent vaccine which contains combined antigens derived from Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, Hepatitis B virus, polio virus and Haemophilus influenzae type b. This combined vaccine is indicated for primary and booster vaccination of children against the viruses and bacteria mentioned above.
Danish: Hexavac er en seksvalent vaccine, som indeholder kombinerede antigener fra Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B-virus, poliovirus samt Haemophilus influenzae type b. Denne kombinationsvaccine er indikeret til primærvaccination og boostervaccination af børn mod ovennævnte vira og bakterier.
English: Between July and September 2005, the marketing authorisation holder gave oral explanations to the CHMP and its working parties on the low immunogenicity of the HepB component in long-term protection against Hepatitis B afforded by Hexavac.
Danish: Mellem juli og september 2005 fremsatte indehaveren af markedsføringstilladelsen mundtlige forklaringer til CHMP og arbejdsgrupperne om HepB-komponentens lave immunogenicitet ved den langtidsbeskyttende effekt af Hexavac mod hepatitis B.
English: Considering all points raised, including time lines required to fully explore all issues related to low HepB immunogenicity following vaccination with Hexavac, the CHMP recommended the suspension for the Marketing Authorisation of Hexavac.
Danish: Når der tages højde for alle fremsatte synspunkter, herunder de tidslinjer, der er nødvendige for at gennemføre en fuldstændig undersøgelse af alle de problemer, der er forbundet med en lav HepBimmunogenicitet efter vaccination med Hexavac, anbefaler CHMP, at markedsføringstilladelsen for Hexavac suspenderes.
English: These facts were put into perspective with the clinical consequences observed so far and the apparent low benefits and uncertainties obtained from the Hepatitis B vaccination utilising Hexavac for the target population.
Danish: Disse fakta blev sat i det rette perspektiv med de kliniske konsekvenser, der er observeret indtil nu, og de tydelige få fordele samt usikkerheder, der er forbundet med hepatitis B-vaccination med Hexavac for målpopulationen.
English: The concerns over the immunogenicity of the HepB component increased when lower than expected seroconversion rates were observed following the concomitant administration of Hexavac with other meningococcal and pneumococcal vaccines.
Danish: Bekymringerne for HepB-komponentens immunogenicitet voksede, da der blev observeret lavere serokonversionsrater end forventet efter samtidig administration af Hexavac og andre meningokok- og pneumokokvacciner.
English: On 26 May 2005, the CHMP agreed on the need to convene an Ad Hoc Expert Group Meeting on Hepatitis short and long-term protection afforded by recombinant Hepatitis B vaccines.
Danish: CHMP vedtog den 26. maj 2005, at der er behov for at indkalde til et ad hoc-ekspertgruppemøde om rekombinante hepatitis B-vacciners lang- og korttidsbeskyttende effekt mod hepatitis.
English: Reference was made to the highly variable quality of the HepB component contained in Hexavac emerging from a manufacturing production in which the root cause of the low immunogenicity has failed to be identified.
Danish: Der blev henvist til den stærkt svingende kvalitet af HepB-komponenten i Hexavac, som viser sig under en fremstillingsproces, hvor hovedårsagen til den lave immunogenicitet ikke er blevet identificeret.
English: The MAH proposed the development of strategies to identify the source of the problem, as well as to produce a more immunogenic formulation.
Danish: Indehaveren af markedsføringstilladelsen foreslog en udvikling af strategier, som kan identificere problemkilden og finde frem til en mere immunogen formel.
English: Notwithstanding the MAH proposals, the CHMP considered that the applicability of the MAH proposals need to be substantiated by data, which validity needs to be determined.
Danish: Til trods for forslagene fra indehaveren af markedsføringstilladelsen, mente CHMP, at anvendeligheden af forslagene fra indehaveren af markedsføringstilladelsen skal dokumenteres af data, som kræver en nærmere undersøgelse.
English: Nevertheless, in accordance with the current knowledge, the CHMP considers that childhood Hepatitis B vaccines should be as immunogenic as possible necessitating a maximum of a single booster dose during adolescence to ensure protective efficacy at the time vaccinated subjects might be exposed to a higher risk of infection compared to infancy and childhood.
Danish: Ikke desto mindre mener CHMP i henhold til den aktuelle viden, at hepatitis B-vacciner til børn skal være så immunogene som muligt, hvilket nødvendiggør en enkelt maksimumbooster-dosis i pubertetsalderen for at sikre en beskyttende effekt på det tidspunkt, hvor vaccinerede patienter muligvis udsættes for en højere infektionsrisiko i forhold til spædbørnsalderen og barndommen.
English: Furthermore, the MAH has proposed to change the Product Information (PI), namely separate administration of pneumococcal and meningococcal conjugate vaccines.
Danish: Desuden foreslog indehaveren af markedsføringstilladelsen, at produktoplysningerne ændres, særligt vedrørende separat administration af pneumokok- og meningokok-konjugatvacciner.
English: Overall, the CHMP considered the multifactorial nature of the low immunogenicity of the HepB component in Hexavac.
Danish: CHMP overvejede generelt den multifaktorelle art af den lave immunogenicitet af Hexavacs HepBkomponent.
English: The CHMP expressed concerns that there is evidence of unpredictable variability in Hepatitis B antibody response following vaccination with Hexavac.
Danish: CHMP udtrykte bekymring over, at der foreligger dokumentation for uforudsigelig variabilitet i antistofresponsen på hepatitis B efter vaccination med Hexavac.
English: The MAH reiterated their commitment to establish a test to discriminate batches of Hexavac which have elucidated a good vs. an insufficient immune response during clinical trials.
Danish: Indehaveren af markedsføringstilladelsen bekræftede sin forpligtelse til at etablere en test, som kan skelne mellem Hexavac-partier, som har udvist en god immunrespons og en utilstrækkelig immunrespons under kliniske forsøg.
English: Additional concerns were raised by the recent finding that children primary immunised with Hexavac apparently respond to a booster dose of a monovalent Hepatitis B vaccine as a function of the geometric mean titres (GMTs) achieved upon completion of the primary immunisation series.
Danish: Der blev givet udtryk for bekymringer med hensyn til det seneste resultat, som påviser, at børn, der har modtaget en primærvaccine med Hexavac, tilsyneladende responderer på en booster-dosis af en monovalent hepatitis B-vaccine som en funktion af de antistoftitre, der blev opnået efter afslutning på den primære immunisering.
English: Concerns were expressed on the low immunogenicity of the HepB component of Hexavac and the potential consequences on long-term protection against Hepatitis B infection and boostability post primary course of vaccination with this vaccine.
Danish: Der blev udtrykt bekymring over HepB-komponentens lave immunogenicitet i Hexavac, de mulige konsekvenser ved langtidsbeskyttelse mod hepatitis B-infektion og booster-evnen efter det primære vaccinationsforløb med denne vaccine.
English: • The CHMP considered that the benefit/risk balance of Hexavac for primary and booster vaccination of children against diphtheria, tetanus, pertussis, Hepatitis B caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by Haemophilus influenzae type
Danish: • CHMP medtog i sine overvejelser, at benefit/risk-forholdet for Hexavac til primærvaccination og booster-vaccination af børn mod difteri, stivkrampe, kighoste, hepatitis B, forårsaget af alle kendte virussubtyper, børnelammelse og invasive infektioner, forårsaget af Haemophilus influenzae type har CHMP anbefalet, at markedsføringstilladelsen for Hexavac suspenderes.
English: The CHMP identified that the decreased immunogeniticy of the HepB component released by the MAH seems to be due to variability in the production process for this component.
Danish: CHMP identificerede, at den nedsatte immunogenicitet af den HepB-komponent, som er frigivet af indehaveren af markedsføringstilladelsen, skyldes variabiliteten i produktionsprocessen for denne komponent.
English: • The CHMP identified that the decreased immunogeniticy of the HepB component released by the MAH seems to be due to variability in the production process for this component.
Danish: • CHMP identificerede, at den nedsatte immunogenicitet af den HepB-komponent, som er frigivet af indehaveren af markedsføringstilladelsen, skyldes variabiliteten i produktionsprocessen for
English: • Considering the data on low immunogenicity available today, the CHMP identified a potential risk associated to continued vaccination with Hexavac, in terms of long-term protection against Hepatitis B infection and subject boostability post priming with Hexavac.
Danish: • Hvis der tages højde for de data, der foreligger om lav immunogenicitet i dag, har CHMP identificeret en mulig risiko, som er forbundet med fortsat vaccination med Hexavac, hvad angår langtidsbeskyttelse mod hepatitis B-infektion og patientens booster-evne efter priming med
English: Considering the data on low immunogenicity available today, the CHMP identified a potential risk associated to continued vaccination with Hexavac, in terms of long-term protection against Hepatitis B infection and subject boostability post priming with Hexavac.
Danish: Hvis der tages højde for de data, der foreligger om lav immunogenicitet i dag, har CHMP identificeret en mulig risiko, som er forbundet med fortsat vaccination med Hexavac, hvad angår langtidsbeskyttelse mod hepatitis B-infektion og patientens booster-evne efter priming med Hexavac.
English: Unpredictable variances to the immunogenicity of the HepB component were investigated by the MAH.
Danish: Indehaveren af markedsføringstilladelsen undersøgte de uforudsigelige variationer i HepBkomponentens immunogenicitet.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TRAZEC
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) TRAZEC
English: Most of the patients received treatment for up to six months: 789 received it for at least six months, and 190 received it for a year.
Danish: De fleste af patienterne modtog behandling i op til 6 måneder, 789 i mindst 6 måneder og 190 fik Trazec i 1 år.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Trazec to Novartis Europharm Limited on 3 April 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Trazec til Novartis Europharm Limited den 3. april 2001.
English: What is the risk associated with Trazec?
Danish: Hvilken risiko er der forbundet med Trazec?
English: Trazec is given within one to 30 minutes before breakfast, lunch and dinner and the dose is adjusted to give the best control.
Danish: Trazec indtages 1-30 minutter før måltidet (inden morgenmaden, frokosten og middagen), og dosen justeres for at give den bedste kontrol.
English: Its use is not recommended in pregnancy or while breast feeding.
Danish: Lægemidlet anbefales ikke anvendt ved graviditet eller amning.
English: This dose may need to be increased to a daily dose of 120 mg three times a day after one or two weeks.
Danish: Denne dosis skal muligvis øges til en daglig dosis på 120 mg tre gange dagligt efter en eller to uger.
English: It is available as pink, round (60 mg), yellow, oval (120 mg) and red, oval (180 mg) tablets.
Danish: Det leveres som en lyserød (60 mg), gul (120 mg) eller rød (180 mg) tablet.
English: The maximum total daily dose is 180 mg three times a day.
Danish: Den samlede daglige maksimumsdosis er 180 mg tre gange dagligt.
English: The recommended starting dose is 60 mg three times a day before meals.
Danish: Den anbefalede startdosis er 60 mg tre gange dagligt inden måltidet.
English: This helps to keep the blood glucose controlled after meals and is used to control
Danish: Dette medvirker til at holde blodglukosen under kontrol efter måltiderne
English: Nateglinide, the active ingredient in Trazec, stimulates the pancreas to produce insulin more quickly.
Danish: Nateglinide, det aktive stof i Trazec, stimulerer bugspytkirtlen til at producere insulin hurtigere.
English: Trazec is a medicine contains the active substance nateglinide.
Danish: Trazec er et lægemiddel, som indeholder det aktive stof nateglinide.
English: The Committee recommended that Trazec be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Trazec.
English: A total of 2,122 patients received Trazec in all trials combined.
Danish: Sammenlagt blev 2 122 patienter behandlet med Trazec i undersøgelserne.
English: The Committee for Medicinal products for Human Use (CHMP) decided that Trazec's benefits are greater than its risks for the treatment of type 2 diabetes, in combination with metformin, in patients who are not controlled despite receiving the maximum daily dose of metformin.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved Trazec er større end risiciene ved behandling af type 2- diabetes i kombination med metformin hos patienter, som ikke er under kontrol trods modtagelse af den maksimale daglige dosis af metformin.
English: A doctor should regularly test the patient's blood glucose to find the lowest effective dose.
Danish: Patientens blodsukker skal kontrolleres regelmæssigt af en læge for at fastsætte den effektive minimumsdosis.
English: In combination with metformin, which mainly affected fasting plasma glucose (the amount of glucose in the blood when the person has not eaten anything), the effect of Trazec on HbA1c was better than either medicine alone.
Danish: I kombination med metformin, som hovedsagelig indvirker på plasmaglukosen i fastende tilstand (mængden af sukker i blodet, når personen ikke har spist noget), var effekten af Trazec på HbA1c bedre end nogen af lægemidlerne alene.
English: The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Danish: I undersøgelserne målte man blodets indhold af et stof kaldet glykosyleret hæmoglobin (HbA1c), der viser, hvor godt blodets sukkerindhold reguleres.
English: Other common side effects (seen in between 1 and 10 patients in 100) are abdominal (tummy) pain, diarrhoea, dyspepsia (heartburn), and nausea (feeling sick).
Danish: De øvrige almindelige bivirkninger (som ses hos mellem 1 og 10 patienter ud af 100) er abdominale smerter (mavesmerter), diarré, dyspepsi (haldbrand) og kvalme.
English: Trazec should not be used in people who may be hypersensitive (allergic) to nateglinide or any of the other ingredients, who have type 1 diabetes, a severe liver problem, or who have diabetic ketoacidosis (a serious complication of diabetes).
Danish: Trazec bør ikke anvendes af personer, som kan være overfølsomme (allergiske) over for nateglinide eller et af de øvrige stoffer, og som har type 1-diabetes eller en svær leversygdom, eller som har diabetisk ketoacidose (en alvorlig komplikation ved diabetes).
English: Trazec doses might also need to be adjusted when given with some medicines used in heart conditions, to treat pain, to treat asthma, and other conditions.
Danish: Det kan også være nødvendigt at justere doseringen af Trazec, når det gives sammen med visse andre lægemidler, der anvendes ved hjertesygdomme, til behandling af smerter, astma og andre sygdomme.
English: On its own, Trazec was shown to be more effective than placebo, but less effective than some antidiabetes medicines such as metformin.
Danish: Trazec som monoterapi viste sig at være mere effektiv end placebo, men mindre effektiv end visse lægemidler mod diabetes såsom metformin.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood.
Danish: Type 2-diabetes er en sygdom, hvor bugspytkirtlen ikke producerer tilstrækkeligt insulin til at regulere blodets glykosekoncentration.
English: Trazec is used in patients who have non insulin-dependent diabetes (type 2 diabetes).
Danish: Trazec anvendes til patienter, som lider af ikke-insulinkrævende diabetes (type 2-diabetes).
English: For the full list of all side effects reported with Trazec, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Trazec fremgår af indlægssedlen.
English: Trazec may in some cases cause hypoglycaemia (low blood glucose).
Danish: Trazec kan i visse tilfælde forårsage hypoglykæmi (lavt blodsukker).
English: Trazec is used together with metformin (another antidiabetes medicine) to lower blood glucose (sugar) in patients whose diabetes cannot be controlled by metformin alone.
Danish: Trazec anvendes sammen med metformin (et andet middel mod sukkersyge) til at sænke blodglykosen (blodsukkeret) hos patienter, hvis sukkersyge ikke kan kontrolleres med metformin alene.
English: The main studies compared Trazec to placebo (a dummy treatment), or to other medicines used in type 2 diabetes (metformin, glibenclamide or troglitazone).
Danish: I hovedundersøgelserne blev Trazec sammenlignet med placebo (uvirksom behandling) eller med andre lægemidler til behandling af type 2-diabetes (metformin, glibenclamid eller troglitazon).
English: The marketing authorisation was renewed
Danish: Markedsføringstilladelsen blev
English: Other studies also looked at ‘switching' from an antidiabetes medicine to Trazec, and ‘adding' Trazec to other antidiabetes medicines.
Danish: Endvidere blev der gennemført andre undersøgelser af dels et ”skift” fra et lægemiddel mod diabetes til Trazec, dels af Trazec som ”tillægsbehandling” til andre lægemidler mod diabetes.
English: What benefit has Trazec shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Trazec?
English: It is available as tablets (600 mg).
Danish: Det fås som tabletter (600 mg).
English: The recommended dose of Efavirenz Teva for adults is 600 mg once a day.
Danish: Den anbefalede dosis af Efavirenz Teva til voksne er 600 mg én gang dagligt.
English: The full EPAR for Efavirenz Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Efavirenz Teva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Efavirenz Teva on 9 January 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Efavirenz Teva den 09 januar 2012.
English: It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells in the body and make more viruses.
Danish: Det blokerer aktiviteten af revers transkriptase, et enzym, som produceres af hiv, og som gør det muligt for det at inficere celler i kroppen og producere mere virus.
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 Efavirenz Teva.
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 Efavirenz Teva.
English: It is used together with other antiviral medicines to treat adults and children aged three years or older infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Det anvendes sammen med andre antivirale lægemidler til behandling af voksne og børn på tre år og derover, som er smittet med humant immundefektvirus type 1 (hiv-1).
English: Efavirenz Teva does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Efavirenz Teva helbreder ikke hivinfektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: For more information about treatment with Efavirenz Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Efavirenz Teva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is recommended that Efavirenz Teva be taken on an empty stomach and without food, preferably at bedtime.
Danish: Det anbefales, at Efavirenz Teva tages på tom mave og uden samtidig fødeindtagelse, fortrinsvis ved sengetid.
English: Patients taking rifampicin (an antibiotic) may need to take a higher dose of Efavirenz Teva.
Danish: Patienter, der tager rifampicin (et antibiotikum) kan være nødt til at tage en højere dosis Efavirenz Teva.
English: This is a summary of the European public assessment report (EPAR) for Efavirenz Teva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Efavirenz Teva.
English: This means that Efavirenz Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Sustiva.
Danish: Det betyder, at Clopidogrel Teva er identisk med et ‘referencelægemiddel', der allerede er godkendt i Den Europæiske Union, og som hedder Sustiva.
English: Efavirenz Teva tablets are not suitable for children weighing less than 40 kg. Efavirenz-containing capsules are available for these patients.
Danish: Efavirenz Teva-tabletter er ikke egnede til børn, der vejer mindre end 40 kg. Der findes kapsler indeholdende Efavirenz til disse patienter.
English: Therefore, the CHMP's view was that, as for Sustiva, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Sustiva.
English: The CHMP concluded that, in accordance with EU requirements, Efavirenz Teva has been shown to have comparable quality and to be bioequivalent to Sustiva.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Efavirenz Teva er af sammenlignelig kvalitet og er bioækvivalent med Sustiva.
English: By blocking this enzyme, Efavirenz Teva, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Ved at blokere dette enzym reducerer Efavirenz Teva, i kombination med andre antiretrovirale lægemidler, hiv-mængden i blodet og holder den nede.
English: The active substance in Efavirenz Teva, efavirenz, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Danish: Det aktive stof i Efavirenz Teva, nevirapin, er en non-nukleosid revers transkriptasehæmmer (NNRTI).
English: Treatment with Efavirenz Teva should be started by a doctor who has experience in the management of HIV infection.
Danish: Behandling med Efavirenz Teva bør indledes af en læge med erfaring i behandling af hivinfektion.
English: Because Efavirenz Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Sustiva.
Danish: Da Efavirenz Teva er et generisk lægemiddel, har patientundersøgelserne været begrænset til tests for at påvise, at det er bioækvivalent med referencelægemidlet, Sustiva.
English: EPAR summary for the public efavirenz
Danish: EPAR sammendrag for offentligheden efavirenz
English: Because Efavirenz Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Efavirenz Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.