FrancophonIA/ELRC3.0 huggingface dataset:
English: • invasive diseases (such as meningitis) caused by H. influenzae type b bacteria.
Danish: • invasive sygdomme (såsom meningitis) forårsaget af bakterien H. influenzae type b.
English: Hexacima contains small amounts of materials derived from the bacteria and viruses it protects against.
Danish: Hexacima indeholder små mængder af materialer, der stammer fra bakterien og virusset, som det beskytter imod.
English: What is Hexacima and what is it used for?
Danish: Hvad er Hexacima, og hvad anvendes det til?
English: It is not intended to provide practical advice on how to use Hexacima.
Danish: Det er ikke en praktisk vejledning i, hvordan Hexacima bør anvendes.
English: It must not be used in children who have an uncontrolled or severe illness affecting the brain or nervous system, such as uncontrolled epilepsy, unless the condition has stabilised with treatment and the benefit clearly outweighs the risk.
Danish: Vaccinen må ikke anvendes til børn med ukontrolleret eller svær hjerne- eller nervesygdom, såsom ukontrolleret epilepsi, medmindre sygdommen er stabiliseret ved behandling, og fordelene klart opvejer risikoen.
English: Why is Hexacima approved?
Danish: Hvorfor blev Hexacima godkendt?
English: This means that some of the active substances are fixed onto aluminium compounds, to stimulate a better response.
Danish: Det betyder, at nogle af de aktive stoffer er bundet til aluminiumholdige forbindelser, der forstærker vaccinens virkning.
English: • poliomyelitis (polio, a disease that affects the nerves and can lead to muscle weakness or paralysis);
Danish: • poliomyelitis (polio, en sygdom, der angriber nerverne og kan medføre muskelsvaghed eller lammelse)
English: A booster dose should be given at least six months after the last of these initial doses.
Danish: Der bør gives en boosterdosis (forstærkningsdosis) mindst seks måneder efter den sidste af disse startdoser.
English: What are the risks associated with Hexacima?
Danish: Hvilke risici er der forbundet med Hexacima?
English: When a child is given the vaccine, the immune system recognises the parts of the bacteria and viruses as ‘foreign' and makes antibodies against them.
Danish: Når et barn bliver vaccineret, opfatter immunsystemet bakteriedelene og virussene som "fremmede" og danner antistoffer mod dem.
English: The recommended initial vaccination schedule is either two doses, given two months apart or three doses, given at least one month apart.
Danish: Den anbefalede indledende vaccinationsplan er enten to doser, der gives med to måneders mellemrum, eller tre doser, der gives med mindst én måneds mellemrum.
English: Regarding safety, the CHMP considered that Hexacima's overall safety profile is similar to other vaccines, although Hexacima is more likely than similar vaccines to cause reactions (mainly at the injection site).
Danish: Med hensyn til sikkerheden fandt CHMP, at Hexacimas sikkerhedsprofil overordnet svarer til andre vacciners, omend der er større sandsynlighed for, at Hexacima i forhold til lignende vacciner vil fremkalde reaktioner (hovedsagelig på injektionsstedet).
English: Hexacima is given by deep injection into a muscle, normally in the upper thigh or the shoulder.
Danish: Hexacima gives ved dyb indsprøjtning i en muskel, sædvanligvis i den øverste del af låret eller i skulderen.
English: Hexacima has been studied in several countries worldwide in 12 main studies involving over 3,400 children between six weeks and two years of age who were given three doses of the vaccine during their first six months of life according to different local vaccination schedules.
Danish: Hexacima er blevet undersøgt i en række lande over hele verden i 12 hovedundersøgelser med over 3 400 børn mellem seks uger og to år gamle, der fik tre doser af vaccinen inden seksmåneders alderen i henhold til forskellige lokale vaccinationsplaner.
English: The immune system will then be able to produce antibodies quickly when the person is naturally exposed to the bacteria or viruses.
Danish: Derefter vil immunsystemet fremover hurtigt kunne danne antistoffer, når personen udsættes for de samme bakterier eller virusser.
English: The effects were compared with a combination of separate vaccines designed to protect against the diseases included in Hexacima.
Danish: Virkningen blev sammenlignet med en kombination af separate vacciner mod de sygdomme, der dækkes af Hexacima.
English: • hepatitis B (a viral liver infection);
Danish: • hepatitis B (en virusforårsaget leverbetændelse)
English: For more information about treatment with Hexacima, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Hexacima, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Five of these studies examined the effect of giving a booster dose at least 6 months after the initial vaccination schedule in 1,511 children.
Danish: Fem af undersøgelserne vedrørte virkningen af en boosterdosis, der blev givet til 1 511 børn mindst seks måneder efter den første vaccinationsplan.
English: Hexacima must not be used in children who have ever had an allergic reaction to Hexacima or a vaccine containing the same components, including substances used during the manufacture of the vaccine and which may be found at extremely low levels (such as the antibiotics neomycin or streptomycin).
Danish: Hexacima må ikke anvendes til børn, som tidligere har haft en allergisk reaktion over for Hexacima eller en vaccine, der indeholder de samme komponenter, herunder stoffer, der anvendes ved fremstilling af vaccinen og som muligvis kan forefindes i ekstremt små mængder (som f.eks. antibiotikaene neomycin eller streptomycin).
English: Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Danish: Difteri, tetanus, pertussis (acellulær, komponent), hepatitis B (rDNA), poliomyelitis (inaktiveret) og Haemophilus influenzae type b konjugeret vaccine (adsorberet)
English: These studies showed that Hexacima produces similar antibody profiles over time to comparable vaccines, and that the vaccine can be given at the same time as Prevenar and Rotarix.
Danish: Undersøgelserne viste, at Hexacima frembringer antistofdannelse med samme forløb over tid som andre tilsvarende vacciner, og at vaccinen kan gives samtidig med Prevenar og Rotarix.
English: The most common side effects with Hexacima include pain and redness at the site of injection, irritability and crying.
Danish: De hyppigste bivirkninger ved Hexacima er smerter og rødme på injektionsstedet, irritabilitet og grådreaktion.
English: The CHMP noted that Hexacima has been shown to produce protective antibody levels against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and H. influenzae type b infections in children between six weeks and two years of age regardless of ethnicity.
Danish: CHMP bemærkede, at Hexacima har vist sig at udvikle beskyttende antistofniveauer mod difteri, stivkrampe, kighoste, hepatitis B, poliomyelitis og H. influenzae type b-infektioner hos børn mellem seks uger og to år uanset etnisk oprindelse.
English: For practical information about using Hexacima, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Hexacima, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Hexacima or an appropriate combination of other vaccines can be used for the booster dose.
Danish: Som boosterdosis kan anvendes Hexacima eller en passende kombination af andre vacciner.
English: It must not be used in children who have ever had encephalopathy (a brain disease) of unknown cause within seven days of receiving a vaccine containing pertussis components in the past.
Danish: Hexacima må ikke anvendes hos børn, der tidligere har fået encefalopati (en hjernesygdom) af ukendt årsag inden for syv dage efter at være blevet vaccineret med en vaccine indeholdende komponenter af kighoste (pertussis).
English: In the study, children who received Hexacima produced a similar antibody response to those who received a comparator vaccine (Infanrix hexa), when given as a two-dose schedule followed by a booster 6 months later.
Danish: I denne undersøgelse udløstes der hos de børn, der fik Hexacima, en antistofrespons, der svarede til antistofresponsen hos de børn, der fik en sammenligningsvaccine (Infanrix hexa), når vaccinen blev givet som en todosisplan efterfulgt af en boostervaccine seks måneder senere.
English: How is Hexacima used?
Danish: Hvordan anvendes Hexacima?
English: Hexacima is a vaccine containing active substances derived from diphtheria, tetanus, pertussis and Haemophilus influenzae type b bacteria, the hepatitis B virus, and inactivated polioviruses.
Danish: Hexacima er en vaccine, der indeholder aktive stoffer afledt af difteri-, stivkrampe-, kighoste- og Haemophilus influenzaetype b-bakterier, hepatitis B-virus og inaktiverede poliovirusser.
English: For the full list of all side effects reported with Hexacima, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Hexacima fremgår af indlægssedlen.
English: What benefits of Hexacima have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Hexacima?
English: The studies showed that protective antibody levels against the various diseases developed in between 90 and 100% of children after the first three doses of Hexacima; protection was maintained or improved when a booster dose was given.
Danish: Undersøgelserne viste, at der hos mellem 90 % og 100 % af børnene blev dannet en beskyttende mængde antistoffer mod de forskellige sygdomme efter de første tre doser af Hexacima.
English: Vaccination with Hexacima should be postponed if a child has a moderate to severe fever.
Danish: Hos børn med moderat til svær feber bør vaccination med Hexacima udsættes.
English: The main measure of effectiveness was the production of antibody levels known to be protective against those diseases.
Danish: Vaccinationens virkning blev hovedsagelig bedømt ved dannelsen af beskyttende antistoffer mod de pågældende sygdomme.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hexacima have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Hexacima.
English: Hexacima is available as a suspension for injection in vials and prefilled syringes.
Danish: Hexacima leveres som injektionsvæske (suspension) i hætteglas og fyldte sprøjter.
English: How does Hexacima work?
Danish: Hvordan virker Hexacima?
English: A subsequent study involving 455 children looked at the longer-term persistence of protective antibodies up to 3 years after a booster dose with Hexacima, and another study in 1,336 children evaluated the response to different lots of the vaccine and what happened when it was given with vaccines for infections caused by the bacterium Streptococcus pneumoniae (Prevenar) and rotavirus (Rotarix).
Danish: Endnu en undersøgelse med 1 336 børn vedrørte virkningen af forskellige vaccinebatcher (produktionsserier), og hvad der skete, når vaccinen blev givet sammen med vacciner mod bakterien Streptococcus pneumoniae (Prevenar) og rotavirus (Rotarix).
English: If you have too much or too little, try again until you have the correct amount.
Danish: Hvis du har for meget eller for lidt, så prøv igen indtil du har den korrekte mængde.
English: If the patient weighs this many kg
Danish: Hvis patienten vejer så mange kg
English: Rebetol must not be used alone.
Danish: Rebetol må ikke tages alene.
English: Reminder: Your doctor may have changed the amount based on recent test results.
Danish: Bemærk: Din læge kan have ændret mængden baseret på de seneste testresultater.
English: Do not chew the hard capsules.
Danish: Tyg ikke de hårde kapsler.
English: Do not have sex with a pregnant woman unless you use a condom.
Danish: Hav ikke samleje med en gravid kvinde, medmindre du bruger kondom.
English: 2220 Heist op den Berg Belgium
Danish: 2220 Heist op den Berg Belgien
English: A patient may be missing or have had a different result for week 4 or week 12.
Danish: En patient kan mangle eller have haft et andet resultat for uge 4 og uge 12.
English: Once the bottle has been opened, the oral solution can be used for 1 month.
Danish: Når flasken er blevet åbnet, kan den orale opløsning anvendes i en måned.
English: However, absolute bioavailability is approximately 45 %-65 %, which appears to be due to first pass metabolism.
Danish: Den absolutte biotilgængelighed er imidlertid omkring 45 %-65 %, hvilket synes at skyldes first pass metabolisme.
English: Try not to let the oral syringe touch the inside of the mouth.
Danish: Prøv at undgå, at den orale sprøjte rører indersiden af munden.
English: • had a serious heart problem during the past 6 months.
Danish: • hvis du har haft alvorlige hjerteproblemer inden for de sidste 6 måneder.
English: Therefore, your blood will be checked regularly to be sure that the HIV infection is not getting worse.
Danish: Dit blod vil derfor blive undersøgt regelmæssigt for at sikre, at hiv-infektionen ikke forværres.
English: Overall Response a (n = 118)
Danish: Samlet respons a (n=118)
English: Talk to your doctor if you or the child you are caring for:
Danish: Tal med din læge, hvis du eller barnet du har ansvar for:
English: If the syringe has touched the inside of the mouth, rinse it with water before inserting it in the bottle again.
Danish: Hvis sprøjten rører indersiden af munden, så skyl den med vand, før den indføres i flasken igen.
English: If you are pregnant, you must not take this medicine.
Danish: Hvis du er gravid, må du ikke tage dette lægemiddel.
English: Clearance increased as a function of body weight and was reduced at ages greater than 40 years.
Danish: Clearance steg som en funktion af legemsvægten og faldt ved højere alder end 40 år.
English: C. Pull the rod out until you can read the correct number of mL for the dose you are measuring.
Danish: C. Træk stangen ud, indtil du kan læse det korrekte antal ml for den dosis, du afmåler.
English: Reduce Rebetol dose* if:
Danish: Reducer Rebetol-dosis*, hvis:
English: The syringe should be rinsed with water after each use to avoid stickiness.
Danish: Sprøjten bør skylles med vand efter hver anvendelse for at undgå klæbrighed.
English: Combination therapy also decreased the relapse rate.
Danish: Kombinationsbehandling sænkede også relapsraten.
English: Date of first authorisation: 25 January 2005 Date of latest renewal: 23 April 2009
Danish: Dato for første tilladelse: 25. januar 2005 Dato for seneste fornyelse: 23. april 2009
English: Caucasian patients had a higher sustained virologic response rate compared to the African Americans.
Danish: Kaukasiske patienter havde en højere vedvarende virologisk respons rate i forhold til de afroamerikanske.
English: However, if a week 12 response was achieved, there was little difference in SVR regardless of prior treatment or prior response.
Danish: Hvis respons i 12. uge imidlertid var opnået, var der en lille forskel i SVR uanset tidligere behandling eller tidligere respons.
English: 3 years After first opening: the medicinal product should be used within one month.
Danish: 3 år Efter anbrud: Lægemidlet bør anvendes inden for en måned.
English: If it gets worse, your doctor will decide whether or not your Rebetol treatment needs to be changed.
Danish: Hvis den forværres, vil din læge beslutte, om din Rebetolbehandling skal ændres.
English: Date of first authorisation: 07 May 1999 Date of latest renewal: 23 April 2009
Danish: Dato for første tilladelse: 07. maj 1999 Dato for seneste fornyelse: 23. april 2009
English: The clinical relevance of results from this single dose study is unknown.
Danish: Den kliniske relevans af resultaterne fra denne enkeltdosis undersøgelse er uvis.
English: It is not known whether Rebetol is excreted in human milk.
Danish: Det er ukendt, om Rebetol udskilles i human mælk.
English: Caution should be exercised when both medicines are co-administered.
Danish: Der bør udvises forsigtighed, når de 2 lægemidler administreres samtidigt.
English: Elderly ( 65 years of age)
Danish: Ældre ( 65 år)
English: D. Take the oral syringe out of the bottle and check to see that the correct amount appears in the bottom of the syringe.
Danish: D. Tag den orale sprøjte ud af flasken og kontroller, at den korrekte mængde synes i bunden af sprøjten.
English: Therefore, it is recommended that renal function be evaluated in all patients prior to initiation of Rebetol.
Danish: Det anbefales derfor, at nyrefunktionen vurderes hos alle patienter før initiering af Rebetol.
English: Men whose partners are pregnant must be instructed to use a condom to minimise delivery of Rebetol to the partner.
Danish: Mænd, hvis partnere er gravide, skal informeres om at anvende kondom for at minimere overførsel af Rebetol til partneren.
English: This should be discussed with your doctor (see section “Do not take Rebetol”).
Danish: Dette kan diskuteres med din læge (se afsnittet “Tag ikke Rebetol”).
English: Response week 12 % (n/N)
Danish: Respons % 12. uge (n/N)
English: Take/administer the missed dose as soon as possible during the same day.
Danish: Tag/giv den manglende dosis så hurtigt som muligt samme dag.
English: All Genotypes Genotype 1 Genotype 2 Genotype 3 Genotype 4
Danish: Alle Genotyper Genotype 1 Genotype 2 Genotype 3 Genotype 4
English: Upon discontinuation of dosing the half-life was approximately 298 hours, which probably reflects slow elimination from non-plasma compartments.
Danish: Efter ophørt dosering var halveringstiden cirka 298 timer, hvilket sandsynligvis afspejler langsom elimination fra nonplasma compartments.
English: If you forget to take Rebetol
Danish: Hvis du har glemt at tage Rebetol
English: Rebetol should be administered orally with food.
Danish: Rebetol skal gives oralt sammen med mad.
English: Overall Population*
Danish: Samlet population*
English: METAVIR Fibrosis score F2
Danish: METAVIR Fibrose score F2
English: These studies suggest that a carcinogenic potential of ribavirin in humans is unlikely.
Danish: Disse undersøgelser antyder, at potentiel karcinogenicitet af ribavirin hos mennesker, er usandsynlig.
English: The use of Rebetol is contraindicated during pregnancy.
Danish: Rebetol er kontraindiceret under graviditet.
English: The high sustained response rate in this subgroup of patients was identified in an interim analysis (n=49) and prospectively confirmed (n=48).
Danish: Den høje vedvarende responsrate i denne undergruppe af patienter blev identificeret i en interimanalyse (n=49) og prospektivt bekræftet (n=48).
English: • have HIV (human immunodeficiency virus) or have ever had any other problems with your immune system.
Danish: • har hiv- (humant immundefekt virus) infektion eller nogensinde har haft andre problemer med dit immunsystem.
English: In all three treatment groups, sustained virologic response rates were similar.
Danish: I alle tre behandlingsgrupper, var den vedvarende virologiske respons rate ens.
English: b: n = number of responders/number of subjects with given genotype, and assigned treatment duration.
Danish: b: n = antallet af respondenter/antal patienter med given genotype og fastsat behandlingsvarighed.
English: In those patients the SVR was 12 %.
Danish: Hos disse patienter var SVR 12 %.
English: In clinical trial C/I98-580, 1,530 naïve patients were treated for one year with one of the following combination regimens:
Danish: I klinisk studie C/I98-580 blev 1.530 naive patienter behandlet i et år med et af følgende kombinationsregimer:
English: MIU = million international units; TIW = three times a week.
Danish: MIE = millioner internationale enheder; TIW = tre gange ugentlig.
English: Depending on the genotype of the hepatitis C virus that you have, your doctor may choose to treat you with a combination of this medicine with other medicines.
Danish: Afhængigt af hvilken genotype af hepatitis C-virus du har, kan lægen vælge at behandle dig med en kombination af dette lægemiddel og andre lægemidler.
English: The selection of Rebetol formulation is based on individual characteristics of the patient.
Danish: Valg af Rebetol-formulering er baseret på patientens individuelle karakteristika.
English: Study 2
Danish: Undersøgelse 2
English: Long-term efficacy data - Adults
Danish: Data for langtidsvirkning - Voksne
English: Elderly patients ( 65 years of age)
Danish: Ældre patienter (i alderen  65 år)
English: It is unknown whether the Rebetol that is contained in sperm will exert its potential teratogenic or genotoxic effects on the human embryo/foetus.
Danish: Det er uvist, om Rebetol i sædvæske vil udøve de potentielle teratogene eller genotoksiske virkninger på det humane embryo/foster.
English: HCV genotype and baseline virus load are prognostic factors which are known to affect response rates.
Danish: HCV genotype og baseline virusmængde er prognostiske faktorer, som er kendt for at påvirke responsrater.
English: • have another liver problem in addition to hepatitis C infection.
Danish: • har andre problemer med leveren ud over hepatitis C-infektion.
English: This medicine stops the multiplication of hepatitis C virus.
Danish: Dette lægemiddel stopper mangfoldiggørelsen af hepatitis C-virus.
English: The side effect profile was also similar at the lower incidences.
Danish: Bivirkningsprofilen var også den samme ved lavere forekomster.
English: Ninety-four of 107 children enrolled in the 5 year long-term follow-up trial.
Danish: 94 af 107 børn blev inkluderet i det opfølgende 5-årige langtidsstudie.
English: Furthermore, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4 % vs. 1 %) during treatment and during the 6 month follow-up after treatment.
Danish: Derudover blev selvmordstanker eller -forsøg rapporteret hyppigere sammenlignet med voksne patienter (2,4 % mod 1 %) under behandling og i den 6 måneder lange opfølgningsperiode efter behandling.
English: Twenty-four % had bridging fibrosis or cirrhosis (Knodell 3/4).
Danish: Fireogtyve % havde bridging fibrose eller cirrose (Knodell 3/4).
English: Paediatric population No data are available in children below 3 years of age.
Danish: Pædiatrisk population Der foreligger ingen data for børn under 3 år.
English: Specific pharmacokinetic evaluations for elderly subjects have not been performed.
Danish: Specifikke farmakokinetik undersøgelser hos ældre personer er ikke blevet udført.
English: B. While keeping the tip in the liquid, pull the rod out.
Danish: B. Mens du holder spidsen i væsken, trækkes stangen ud.
English: Sustained Virologic Response
Danish: Vedvarende virologisk respons
English: The overall sustained response rate after a 24-week treatment duration was 50 %.
Danish: Den totale vedvarende responsrate efter en 24 ugers behandlingsperiode var 50 %.
English: The mechanism by which Rebetol in combination with other medicinal products exerts its effects against HCV is unknown.
Danish: Mekanismen ved hvilken Rebetol i kombination med andre lægemidler udøver sine virkninger mod HCV er ukendt.
English: This appears to be due to reduction of apparent clearance in these patients.
Danish: Dette synes at være forårsaget af en reduktion af den tilsyneladende clearance hos disse patienter.
English: *Genotype 1 receive 48 weeks treatment **Genotype 2, 3 receive 24 weeks treatment ***The presented results are from a single point of time.
Danish: *Genotype 1 modtager 48 ugers behandling **Genotype 2, 3 modtager 24 ugers behandling ***De præsenterede resultater er fra et enkelt tidspunkt.
English: Female patients
Danish: Kvindelige patienter
English: The clearance model developed showed that body weight, gender, age, and serum creatinine were the main covariates.
Danish: Den fremkomne clearance model viste, at legemsvægt, køn, alder og serum kreatinin var de vigtigste covariate.