natgillin/translations-raw huggingface dataset:
Når et barn bliver vaccineret, opfatter immunsystemet bakteriedelene og virussene som "fremmede" og danner antistoffer mod dem.
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.
Den anbefalede indledende vaccinationsplan er enten to doser, der gives med to måneders mellemrum, eller tre doser, der gives med mindst én måneds mellemrum.
The recommended initial vaccination schedule is either two doses, given two months apart or three doses, given at least one month apart.
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).
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).
Hexacima gives ved dyb indsprøjtning i en muskel, sædvanligvis i den øverste del af låret eller i skulderen.
Hexacima is given by deep injection into a muscle, normally in the upper thigh or the shoulder.
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.
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.
Derefter vil immunsystemet fremover hurtigt kunne danne antistoffer, når personen udsættes for de samme bakterier eller virusser.
The immune system will then be able to produce antibodies quickly when the person is naturally exposed to the bacteria or viruses.
Virkningen blev sammenlignet med en kombination af separate vacciner mod de sygdomme, der dækkes af Hexacima.
The effects were compared with a combination of separate vaccines designed to protect against the diseases included in Hexacima.
• hepatitis B (en virusforårsaget leverbetændelse)
• hepatitis B (a viral liver infection);
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.
For more information about treatment with Hexacima, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Fem af undersøgelserne vedrørte virkningen af en boosterdosis, der blev givet til 1 511 børn mindst seks måneder efter den første vaccinationsplan.
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.
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).
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).
Difteri, tetanus, pertussis (acellulær, komponent), hepatitis B (rDNA), poliomyelitis (inaktiveret) og Haemophilus influenzae type b konjugeret vaccine (adsorberet)
Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
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.
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.
De hyppigste bivirkninger ved Hexacima er smerter og rødme på injektionsstedet, irritabilitet og grådreaktion.
The most common side effects with Hexacima include pain and redness at the site of injection, irritability and crying.
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.
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.
Hvis du ønsker praktisk vejledning om anvendelsen af Hexacima, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Hexacima, patients should read the package leaflet or contact their doctor or pharmacist.
Som boosterdosis kan anvendes Hexacima eller en passende kombination af andre vacciner.
Hexacima or an appropriate combination of other vaccines can be used for the booster dose.
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).
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.
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.
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.
Hvordan anvendes Hexacima?
How is Hexacima used?
Hexacima er en vaccine, der indeholder aktive stoffer afledt af difteri-, stivkrampe-, kighoste- og Haemophilus influenzaetype b-bakterier, hepatitis B-virus og inaktiverede poliovirusser.
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.
Den fuldstændige liste over indberettede bivirkninger ved Hexacima fremgår af indlægssedlen.
For the full list of all side effects reported with Hexacima, see the package leaflet.
Hvilke fordele viser undersøgelserne, at der er ved Hexacima?
What benefits of Hexacima have been shown in studies?
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.
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.
Hos børn med moderat til svær feber bør vaccination med Hexacima udsættes.
Vaccination with Hexacima should be postponed if a child has a moderate to severe fever.
Vaccinationens virkning blev hovedsagelig bedømt ved dannelsen af beskyttende antistoffer mod de pågældende sygdomme.
The main measure of effectiveness was the production of antibody levels known to be protective against those diseases.
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.
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.
Hexacima leveres som injektionsvæske (suspension) i hætteglas og fyldte sprøjter.
Hexacima is available as a suspension for injection in vials and prefilled syringes.
Hvordan virker Hexacima?
How does Hexacima work?
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).
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).
Hvis du har for meget eller for lidt, så prøv igen indtil du har den korrekte mængde.
If you have too much or too little, try again until you have the correct amount.
Hvis patienten vejer så mange kg
If the patient weighs this many kg
Rebetol må ikke tages alene.
Rebetol must not be used alone.
Bemærk: Din læge kan have ændret mængden baseret på de seneste testresultater.
Reminder: Your doctor may have changed the amount based on recent test results.
Tyg ikke de hårde kapsler.
Do not chew the hard capsules.
Hav ikke samleje med en gravid kvinde, medmindre du bruger kondom.
Do not have sex with a pregnant woman unless you use a condom.
2220 Heist op den Berg Belgien
2220 Heist op den Berg Belgium
En patient kan mangle eller have haft et andet resultat for uge 4 og uge 12.
A patient may be missing or have had a different result for week 4 or week 12.
Når flasken er blevet åbnet, kan den orale opløsning anvendes i en måned.
Once the bottle has been opened, the oral solution can be used for 1 month.
Den absolutte biotilgængelighed er imidlertid omkring 45 %-65 %, hvilket synes at skyldes first pass metabolisme.
However, absolute bioavailability is approximately 45 %-65 %, which appears to be due to first pass metabolism.
Prøv at undgå, at den orale sprøjte rører indersiden af munden.
Try not to let the oral syringe touch the inside of the mouth.
• hvis du har haft alvorlige hjerteproblemer inden for de sidste 6 måneder.
• had a serious heart problem during the past 6 months.
Dit blod vil derfor blive undersøgt regelmæssigt for at sikre, at hiv-infektionen ikke forværres.
Therefore, your blood will be checked regularly to be sure that the HIV infection is not getting worse.
Samlet respons a (n=118)
Overall Response a (n = 118)
Tal med din læge, hvis du eller barnet du har ansvar for:
Talk to your doctor if you or the child you are caring for:
Hvis sprøjten rører indersiden af munden, så skyl den med vand, før den indføres i flasken igen.
If the syringe has touched the inside of the mouth, rinse it with water before inserting it in the bottle again.
Hvis du er gravid, må du ikke tage dette lægemiddel.
If you are pregnant, you must not take this medicine.
Clearance steg som en funktion af legemsvægten og faldt ved højere alder end 40 år.
Clearance increased as a function of body weight and was reduced at ages greater than 40 years.
C. Træk stangen ud, indtil du kan læse det korrekte antal ml for den dosis, du afmåler.
C. Pull the rod out until you can read the correct number of mL for the dose you are measuring.
Reducer Rebetol-dosis*, hvis:
Reduce Rebetol dose* if:
Sprøjten bør skylles med vand efter hver anvendelse for at undgå klæbrighed.
The syringe should be rinsed with water after each use to avoid stickiness.
Kombinationsbehandling sænkede også relapsraten.
Combination therapy also decreased the relapse rate.
Dato for første tilladelse: 25. januar 2005 Dato for seneste fornyelse: 23. april 2009
Date of first authorisation: 25 January 2005 Date of latest renewal: 23 April 2009
Kaukasiske patienter havde en højere vedvarende virologisk respons rate i forhold til de afroamerikanske.
Caucasian patients had a higher sustained virologic response rate compared to the African Americans.
Hvis respons i 12. uge imidlertid var opnået, var der en lille forskel i SVR uanset tidligere behandling eller tidligere respons.
However, if a week 12 response was achieved, there was little difference in SVR regardless of prior treatment or prior response.
3 år Efter anbrud: Lægemidlet bør anvendes inden for en måned.
3 years After first opening: the medicinal product should be used within one month.
Hvis den forværres, vil din læge beslutte, om din Rebetolbehandling skal ændres.
If it gets worse, your doctor will decide whether or not your Rebetol treatment needs to be changed.
Dato for første tilladelse: 07. maj 1999 Dato for seneste fornyelse: 23. april 2009
Date of first authorisation: 07 May 1999 Date of latest renewal: 23 April 2009
Den kliniske relevans af resultaterne fra denne enkeltdosis undersøgelse er uvis.
The clinical relevance of results from this single dose study is unknown.
Det er ukendt, om Rebetol udskilles i human mælk.
It is not known whether Rebetol is excreted in human milk.
Der bør udvises forsigtighed, når de 2 lægemidler administreres samtidigt.
Caution should be exercised when both medicines are co-administered.
Ældre ( 65 år)
Elderly ( 65 years of age)
D. Tag den orale sprøjte ud af flasken og kontroller, at den korrekte mængde synes i bunden af sprøjten.
D. Take the oral syringe out of the bottle and check to see that the correct amount appears in the bottom of the syringe.
Det anbefales derfor, at nyrefunktionen vurderes hos alle patienter før initiering af Rebetol.
Therefore, it is recommended that renal function be evaluated in all patients prior to initiation of Rebetol.
Mænd, hvis partnere er gravide, skal informeres om at anvende kondom for at minimere overførsel af Rebetol til partneren.
Men whose partners are pregnant must be instructed to use a condom to minimise delivery of Rebetol to the partner.
Dette kan diskuteres med din læge (se afsnittet “Tag ikke Rebetol”).
This should be discussed with your doctor (see section “Do not take Rebetol”).
Respons % 12. uge (n/N)
Response week 12 % (n/N)
Tag/giv den manglende dosis så hurtigt som muligt samme dag.
Take/administer the missed dose as soon as possible during the same day.
Alle Genotyper Genotype 1 Genotype 2 Genotype 3 Genotype 4
All Genotypes Genotype 1 Genotype 2 Genotype 3 Genotype 4
Efter ophørt dosering var halveringstiden cirka 298 timer, hvilket sandsynligvis afspejler langsom elimination fra nonplasma compartments.
Upon discontinuation of dosing the half-life was approximately 298 hours, which probably reflects slow elimination from non-plasma compartments.
Hvis du har glemt at tage Rebetol
If you forget to take Rebetol
Rebetol skal gives oralt sammen med mad.
Rebetol should be administered orally with food.
Samlet population*
Overall Population*
METAVIR Fibrose score F2
METAVIR Fibrosis score F2
Disse undersøgelser antyder, at potentiel karcinogenicitet af ribavirin hos mennesker, er usandsynlig.
These studies suggest that a carcinogenic potential of ribavirin in humans is unlikely.
Rebetol er kontraindiceret under graviditet.
The use of Rebetol is contraindicated during pregnancy.
Den høje vedvarende responsrate i denne undergruppe af patienter blev identificeret i en interimanalyse (n=49) og prospektivt bekræftet (n=48).
The high sustained response rate in this subgroup of patients was identified in an interim analysis (n=49) and prospectively confirmed (n=48).
• har hiv- (humant immundefekt virus) infektion eller nogensinde har haft andre problemer med dit immunsystem.
• have HIV (human immunodeficiency virus) or have ever had any other problems with your immune system.
I alle tre behandlingsgrupper, var den vedvarende virologiske respons rate ens.
In all three treatment groups, sustained virologic response rates were similar.
b: n = antallet af respondenter/antal patienter med given genotype og fastsat behandlingsvarighed.
b: n = number of responders/number of subjects with given genotype, and assigned treatment duration.
Hos disse patienter var SVR 12 %.
In those patients the SVR was 12 %.
I klinisk studie C/I98-580 blev 1.530 naive patienter behandlet i et år med et af følgende kombinationsregimer:
In clinical trial C/I98-580, 1,530 naïve patients were treated for one year with one of the following combination regimens:
MIE = millioner internationale enheder; TIW = tre gange ugentlig.
MIU = million international units; TIW = three times a week.
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.
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.
Valg af Rebetol-formulering er baseret på patientens individuelle karakteristika.
The selection of Rebetol formulation is based on individual characteristics of the patient.
Undersøgelse 2
Study 2
Data for langtidsvirkning - Voksne
Long-term efficacy data - Adults
Ældre patienter (i alderen  65 år)
Elderly patients ( 65 years of age)
Det er uvist, om Rebetol i sædvæske vil udøve de potentielle teratogene eller genotoksiske virkninger på det humane embryo/foster.
It is unknown whether the Rebetol that is contained in sperm will exert its potential teratogenic or genotoxic effects on the human embryo/foetus.
HCV genotype og baseline virusmængde er prognostiske faktorer, som er kendt for at påvirke responsrater.
HCV genotype and baseline virus load are prognostic factors which are known to affect response rates.
• har andre problemer med leveren ud over hepatitis C-infektion.
• have another liver problem in addition to hepatitis C infection.
Dette lægemiddel stopper mangfoldiggørelsen af hepatitis C-virus.
This medicine stops the multiplication of hepatitis C virus.
Bivirkningsprofilen var også den samme ved lavere forekomster.
The side effect profile was also similar at the lower incidences.
94 af 107 børn blev inkluderet i det opfølgende 5-årige langtidsstudie.
Ninety-four of 107 children enrolled in the 5 year long-term follow-up trial.
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.
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.
Fireogtyve % havde bridging fibrose eller cirrose (Knodell 3/4).
Twenty-four % had bridging fibrosis or cirrhosis (Knodell 3/4).
Pædiatrisk population Der foreligger ingen data for børn under 3 år.
Paediatric population No data are available in children below 3 years of age.
Specifikke farmakokinetik undersøgelser hos ældre personer er ikke blevet udført.
Specific pharmacokinetic evaluations for elderly subjects have not been performed.
B. Mens du holder spidsen i væsken, trækkes stangen ud.
B. While keeping the tip in the liquid, pull the rod out.
Vedvarende virologisk respons
Sustained Virologic Response
Den totale vedvarende responsrate efter en 24 ugers behandlingsperiode var 50 %.
The overall sustained response rate after a 24-week treatment duration was 50 %.
Mekanismen ved hvilken Rebetol i kombination med andre lægemidler udøver sine virkninger mod HCV er ukendt.
The mechanism by which Rebetol in combination with other medicinal products exerts its effects against HCV is unknown.
Dette synes at være forårsaget af en reduktion af den tilsyneladende clearance hos disse patienter.
This appears to be due to reduction of apparent clearance in these patients.
*Genotype 1 modtager 48 ugers behandling **Genotype 2, 3 modtager 24 ugers behandling ***De præsenterede resultater er fra et enkelt tidspunkt.
*Genotype 1 receive 48 weeks treatment **Genotype 2, 3 receive 24 weeks treatment ***The presented results are from a single point of time.
Kvindelige patienter
Female patients
Den fremkomne clearance model viste, at legemsvægt, køn, alder og serum kreatinin var de vigtigste covariate.
The clearance model developed showed that body weight, gender, age, and serum creatinine were the main covariates.
Kun henholdsvis tolv ud af 492 vedvarende respondenter og 3 ud af 366 vedvarende respondenter fik tilbagefald i undersøgelserne.
Twelve out of 492 sustained responders and only 3 out of 366 sustained responders relapsed, respectively, in the studies.
Nedsat voksehastighed (højde- og/eller vægttab i forhold til alder)
Growth rate decrease (height and/or weight decrease for age)
Hold sprøjten op til din mund og frigiv dosis ind i munden (eller munden hos den patient, du tager dig af) ved at trykke stangen ind.
Hold the syringe to your mouth and release the dose into your mouth (or the mouth of the patient you are caring for) by pushing in the rod.
I kliniske undersøgelser udført i denne population, blev Rebetol brugt i en dosis på 15 mg/kg/dag (Tabel 1).
In clinical studies performed in this population, Rebetol was used in doses of 15 mg/kg/day (Table 1).
Hertil kommer, at 98 % (51/52) med normale ALAT niveauer ved opfølgningsuge 24 havde normal ALAT-niveau ved deres sidste besøg.
Additionally, 98 % (51/52) with normal ALT levels at follow-up week 24 maintained normal ALT levels at their last visit.
Selvmordsforsøg, panik anfald, hallucinationer
Suicide attempts, panic attack, hallucination
Rebetol ophobes intracellulært og udskilles meget langsomt fra kroppen.
Rebetol accumulates intracellularly and is cleared from the body very slowly.
Du eller din plejer skal kontakte lægen omgående, hvis du oplever nogle af disse bivirkninger.
You or your caregiver should call your doctor immediately if you have any of these side effects.
Der blev ikke observeret ribavirin effekter på neuroadfærd eller reproduktiv udvikling.
No ribavirin effects were observed regarding neurobehavioural or reproductive development.
Rebetol-kapsler er pakket i blisterpakninger, som består af polyvinylklorid (PVC)/polyethylen (PE)/polyvinyliden klorid (PVdC).
Rebetol capsules are packaged in blisters consisting of polyvinyl chloride (PVC)/polyethylene (PE)/polyvinylidene chloride (PVdC).
Respons på behandlingen i begge af disse undersøgelser er vist i Tabel 11.
The response to treatment in both of these trials is presented in Table 11.
Der synes ikke at være en signifikant aldersrelateret effekt på Rebetols farmakokinetik.
There does not appear to be a significant age-related effect on the pharmacokinetics of Rebetol.
Disse tidspunkter (4- og 12 behandlingsuge) har vist sig at være prædiktiv med hensyn til vedvarende respons (Tabel 10).
These time points (treatment week 4 and treatment week 12) have been shown to be predictive for sustained response (Table 10).
3 kapsler
3 capsules
Dette udelukker imidlertid ikke forekomsten af hepatitistilfælde i patienter med cirrhosis (inklusive hepatocarcinoma).
However, this does not preclude the occurrence of hepatic events in patients with cirrhosis (including hepatocarcinoma).
Hård kapsel (kapsel)
Hard capsule (capsule)
Tag al din medicin: Tag eller indgiv den foreskrevne dosis gennem munden om morgenen og aftenen, til et måltid.
Taking all your medicine: Take or give the prescribed dose by mouth in the morning and evening, with a meal.
(efter Rebetol dosis [mg/kg], genotype og virusmængde) HCV Genotype
(by Rebetol dose [mg/kg], genotype and viral load) HCV Genotype
Rebetols vigtigste sikkerhedsaspekt er hæmolytisk anæmi, der opstår inden for de første uger af behandlingen.
The salient safety issue of Rebetol is haemolytic anaemia occurring within the first weeks of therapy.
Tilføjelse af behandling med en alfa interferon alene eller i kombination med ribavirin kan øge risikoen i denne patientundergruppe.
Adding treatment with an alpha interferon alone or in combination with ribavirin may increase the risk in this patient subset.
Intet vedvarende respons
No sustained Response