natgillin/translations-raw huggingface dataset:
36 France Roche Tél: +33 (0) 1 46 40 50 00 ou Chugai Pharma France Tél: +33 (0) 1 56 37 05 20
France Roche Tél: +33 (0) 1 46 40 50 00 ou Chugai Pharma France Tél: +33 (0) 1 56 37 05 20
Du kan finde yderligere information om RoActemra på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http://www.emea.europa.eu/
Følgende oplysninger er tiltænkt læger og sundhedspersonale:
The following information is intended for medical or healthcare professionals only
Under anvendelse af aseptiske procedurer tages der en mængde steril, pyrogenfri natriumchlorid 9 mg/ ml (0, 9%) injektionsvæske, opløsning fra en 100 ml infusionspose svarende til den påkrævede mængde RoActemra- koncentrat.
Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/ml (0.9%) solution for injection from a 100 ml infusion bag, equal to the volume of RoActemra concentrate required for the patients dose, under aseptic conditions.
Den påkrævede mængde RoActemra- koncentrat (0, 4 ml/ kg) trækkes op af hætteglasset og anbringes i infusionsposen på 100 ml.
The required amount of RoActemra concentrate (0.4 ml/kg) should be withdrawn from the vial and placed in the 100 ml infusion bag.
37 Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
37
Rotarix er en oral vaccine (en vaccine, der indtages gennem munden).
Rotarix is an oral vaccine.
Den fås i to former: • et pulver og en solvens, som blandes til en oral suspension i en oral applikator • en oral suspension i en fyldt oral applikator eller tube Rotarix indeholder en levende fortyndet (svækket) form af human rotavirus (RIX4414- stamme).
It contains a live attenuated (weakened) form of the human rotavirus (RIX4414 strain).
Rotarix anvendes til spædbørn fra seksugersalderen som en vaccine til forebyggelse af gastroenteritis (diarre og opkastning) forårsaget af rotavirusinfektioner.
Rotarix is used in babies from six weeks of age as a vaccine to prevent gastroenteritis (diarrhoea and vomiting) caused by rotavirus infections.
Rotarix gives som to doser med et interval på mindst fire uger.
Rotarix is given as two doses, given at least four weeks apart.
Den første dosis gives, når spædbarnet er over seks uger gammelt.
The first dose is given when the baby is older than six weeks.
Ideelt bør begge doser gives, inden barnet er 16 uger gammelt, og de skal være givet, når barnet er 24 uger gammelt.
It is better if the full course (both doses) is given before the child is aged 16 weeks, and in any case, it should have been given by the time the child is 24 weeks old.
Når det er suspensionen, der anvendes, skal indholdet af den fyldte orale applikator eller tube gives i spædbarnets mund.
The powder and solvent are mixed just before administration, and the resulting suspension is given directly into the mouth of the baby using the oral syringe provided.
Rotarix kan gives samtidigt med andre vacciner.
Rotarix can be given at the same time as other vaccinations.
Dette virus er levende, men er blevet svækket, så det ikke forårsager sygdommen, hvilket gør det egnet til brug i en vaccine.
The virus is alive, but it has been weakened so that it does not cause the disease, and this makes it suitable to use in a vaccine.
Et antistof er et særligt protein, som kan neutralisere eller ødelægge et antigen såsom et smitstof eller et virus.
When a child is given the vaccine, the immune system (the system that fights diseases) recognises the weakened virus as ‘ foreign’ and makes antibodies against it (an antibody is a special protein that can neutralise or destroy an antigen, such as an infectious agent or virus).
Mellem 78 og 95% af spædbørn, som har fået Rotarix, danner antistoffer mod rotavirus efter vaccinationen.
Between 78 and 95% of babies receiving Rotarix make antibodies against rotavirus after vaccination.
Reproduction is authorised provided the source is acknowledged Hvordan blev Rotarix undersøgt?
How has Rotarix been studied?
Virkningerne af Rotarix blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Rotarix were first tested in experimental models before being studied in humans.
De kliniske undersøgelser af Rotarix hos mennesker omfattede over 72 000 spædbørn og blev gennemført i forskellige lande rundt om i verden.
Overall, the clinical studies of Rotarix in humans involved over 72,000 infants and took place in various countries worldwide.
I alle undersøgelserne blev vaccinen sammenlignet med placebo (en uvirksom behandling).
In all studies, the vaccine was compared with a placebo (a dummy vaccine).
I hovedundersøgelsen, som omfattede over 63 000 spædbørn, så man nærmere på Rotarix ’ sikkerhed og virkning.
The main study looked at the effectiveness and safety of Rotarix, and it involved over 63,000 infants.
Undersøgelsen var meget omfattende, fordi den skulle se nærmere på, om vaccinen forårsagede en meget sjælden, alvorlig bivirkning, der kaldes intussusception.
The study was very large because it was designed to see if the vaccine caused a very rare, serious side effect, intussusception, a condition in which part of the bowel becomes enfolded within another part of the bowel, leading to a blockage.
Det er en tilstand, hvor en del af tarmen folder sig sammen med en anden del af tarmen, hvilket fører til blokering.
Effectiveness was measured by looking at how many 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Der blev gennemført fire yderligere undersøgelser hos over 3 000 spædbørn for at bekræfte, at de to former af vaccinen var lige sikre, og at de havde samme virkning med hensyn til at stimulere produktionen af antistoffer mod rotavirus.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged children developed severe rotavirus gastroenteritis in the months after they had been vaccinated (and before they reached one year of age).
I hovedundersøgelse var antallet af tilfælde af svær rotavirusforårsaget gastroenteritis lavere efter vaccinationen med Rotarix:
In over 20,000 children in whom effectiveness was assessed, the number of cases of severe rotavirus gastroenteritis decreased following vaccination with Rotarix:
0, 1% af spædbørnene, som blev vaccineret med Rotarix og hos hvem virkningen blev undersøgt, udviklede svær rotavirus gastroenteritis (12 ud af over 9 000) sammenlignet med 0, 9% blandt dem, der fik placebo (77 ud af næsten 9 000).
12 infants vaccinated with Rotarix developed severe rotavirus gastroenteritis compared to 77 cases among those who received placebo.
31 500 spædbørn fik Rotarix og 31 500 fik placebo, udviklede ni spædbørn intussusception efter vaccination med Rotarix, sammenlignet med 16, som udviklede dette efter at have fået en placebovaccine.
In the main study, in which about 31,500 children received Rotarix and 31,500 received placebo, nine children developed intussusception following vaccination with Rotarix, compared to 16 who developed the disease after receiving a placebo vaccine.
Dette viser, at der ikke er forhøjet risiko for intussusception med Rotarix.
This shows that there is no increased risk of intussusception with Rotarix.
De hyppigste bivirkninger (som ses hos flere end 1 ud af 10 patienter) er irritabilitet og appetitløshed.
The most common side effects (seen in more than 1 patient in 10) are irritability and loss of appetite.
Den fuldstændige liste over de indberettede bivirkninger ved Rotarix fremgår af indlægssedlen.
For the full list of all side effects reported with Rotarix, see the Package Leaflet.
Rotarix må ikke anvendes til spædbørn, der kan være overfølsomme (allergiske) over for et eller flere af indholdsstofferne i vaccinen, eller som tidligere har vist tegn på allergi efter en dosis rotavirusvaccine.
Rotarix should not be used in children who may be hypersensitive (allergic) to any of the ingredients of the vaccine, or who have shown signs of allergy after having received a previous dose of rotavirus vaccine.
Det må ikke gives til børn, som tidligere har haft intussusception, eller som har problemer med tarmene, der kan gøre dem prædisponeret for sygdommen.
It should not be given to children who have had intussusception in the past, or who have problems with their bowel that could predispose them to the disease.
Det må heller ikke gives til børn, hvis immunsystem er svækket.
It should also not be given to children whose immune system is weakened.
Rotarix må ikke under nogen omstændigheder injiceres.
For the full list of restrictions, see the Package Leaflet.
Som det gælder for alle vacciner, kan Rotarix, hvis det anvendes til spædbørn, der er født alt for tidligt, medføre risiko for apnø (korte vejrtrækningspauser).
As for all vaccines, if Rotarix is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Spædbørnenes vejrtrækning bør overvåges i op til tre dage efter vaccinationen, især efter den første vaccination.
Their breathing should be monitored for up to three days after vaccination.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Rotarix er større end risiciene ved vaccination af spædbørn fra seksugersalderen med henblik på forebyggelse af gastroenteritis som følge af rotavirusinfektion.
The Committee for Medicinal Products for Human Use (CHMP) decided that Rotarix’ s benefits are greater than its risks for the vaccination of infants from the age of six weeks for the prevention of gastroenteritis due to rotavirus infection.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Rotarix.
The Committee recommended that Rotarix be given marketing authorisation.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rotarix til GlaxoSmithKline Biologicals s. a. den 21. februar 2006.
The European Commission granted a marketing authorisation valid throughout the European Union for Rotarix to GlaxoSmithKline Biologicals s. a. on 21 February 2006.
Den fuldstændige EPAR for Rotarix findes her.
The full EPAR for Rotarix can be found here.
Dette sammendrag blev sidst ajourført i 09- 2008.
This summary was last updated in 12-2007.
Ikke mindre end 106. 0 CCID50
not less than 106.0 CCID50
Pulver og solvens til oral Oral anvendelse suspension
Powder and solvent for oral suspension
1 glasbeholder + 1 oral applikator + 1 overførselsaggregat
1 glass container + 1 oral applicator + 1 transfer adapter
Oral anvendelse Blød tube (polyethylen)
Squeezable tube (polyethylene)
Rotarix pulver og solvens til oral suspension Rotavirus- vaccine, levende
Rotarix powder and solvent for oral suspension Rotavirus vaccine, live
Efter rekonstituering, indeholder 1 dosis (1 ml):
After reconstitution, 1 dose (1ml) contains:
Human rotavirus RIX4414 stamme (levende svækket) *
Human rotavirus RIX4414 strain (live, attenuated)*
ikke mindre end 106. 0 CCID50
not less than 106.0 CCID50
* fremstillet på veroceller
*Produced on Vero cells
4. 4)
This product contains sucrose 9 mg and sorbitol 13.5 mg (see section 4.4)
Pulveret er hvidt Solvensen er en uklar væske med et langsomt sættende hvidt bundfald og en farveløs supernatant.
The solvent is a turbid liquid with a slow settling white deposit and a colourless supernatant.
4. 2).
Rotarix is indicated for the active immunisation of infants from the age of 6 weeks for prevention of gastro-enteritis due to rotavirus infection (see section 4.2).
I kliniske undersøgelser, er der vist effekt mod gastro- enteritis forårsaget af rotavirus af typerne G1P[ 8], G2P[ 4], G3P[ 8], G4P[ 8] og G9P[ 8] (se pkt 4. 4 og 5. 1).
In clinical trials, efficacy was demonstrated against gastro-enteritis due to rotavirus of types G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8] (see sections 4.4 and 5.1).
Anvendelse af Rotarix bør baseres på officielle rekommandationer.
The use of Rotarix should be based on official recommendations.
Første dosis bør gives fra 6- ugers alderen.
The first dose may be administered from the age of 6 weeks.
Der bør være et interval på mindst 4 uger mellem doserne.
There should be an interval of at least 4 weeks between doses.
Vaccinationsprogrammet skal helst være gennemført før 16- ugers alderen, men skal være afsluttet ved 24- ugers alderen.
The vaccination course should preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks.
Der er kun sjældent observeret spytning eller gylp af vaccinen i de kliniske undersøgelser, og i disse tilfælde blev der ikke givet en erstatningsdosis.
In clinical trials, spitting or regurgitation of the vaccine has rarely been observed and, under such circumstances, a replacement dose was not given.
Det anbefales, at børn, som modtager den første dosis Rotarix, fuldender 2- dosis programmet med Rotarix.
It is recommended that infants who receive a first dose of Rotarix complete the 2-dose regimen with Rotarix.
Der er ingen data med hensyn til sikkerhed, immunogenicitet eller effektivitet hvis Rotarix gives som første dosis og en anden rotavirus- vaccine gives som anden dosis eller vice versa.
There are no data on safety, immunogenicity or efficacy when Rotarix is administered for the first dose and another rotavirus vaccine is administered for the second dose or vice versa.
2 Indgivelsesmåde
2 Method of administration
Overfølsomhed ved tidligere administration af rotavirus- vacciner.
Hypersensitivity after previous administration of rotavirus vaccines.
Tidligere tilfælde af intussusception.
Previous history of intussusception.
Personer med ukorrigeret medfødt misdannelse af mave- tarmkanalen, som vil medføre prædisponering for intussuception.
Subjects with uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
Børn, hvor der er konstateret eller mistanke om nedsat immunforsvar.
Infants who have known or suspected immunodeficiency.
Asymptomatisk HIV- infektion forventes ikke at indvirke på sikkerhed eller effekt af Rotarix.
Asymptomatic HIV infection is not expected to affect the safety or efficacy of Rotarix.
Som følge af manglende erfaring anbefales Rotarix imidlertid ikke til asymptomatiske HIV personer.
However, in the absence of sufficient data, administration of Rotarix to asymptomatic HIV subjects is not recommended.
Administration af Rotarix bør udsættes hos personer, som lider af sygdom med akut og alvorlig feber.
Administration of Rotarix should be postponed in subjects suffering from acute severe febrile illness.
Administration af Rotarix bør udsættes hos personer, der lider af diaré eller opkastning.
The administration of Rotarix should be postponed in subjects suffering from diarrhoea or vomiting.
Det er god klinisk praksis, at den medicinske anamnese tages i betragtning forud for vaccination specielt med hensyn til tidligere kontraindikationer samt, at der udføres en klinisk undersøgelse.
It is good clinical practice that vaccination should be preceded by a review of the medical history especially with regard to the contraindications and by a clinical examination.
Ved hjælp af ELISA blev der målt antigener i 50% af afføringerne efter første dosis og i 4% efter anden dosis.
Viral antigen particles detected by ELISA were found in 50% of stools after the first dose and 4% of stools after the second dose.
Ved undersøgelse af disse afføringsmaterialer for levende vaccinestammer var kun 17% positive.
When these stools were tested for the presence of live vaccine strain, only 17% were positive.
Rotarix bør gives med forsigtighed til personer med pårørende, der har nedsat immunforsvar, så som personer med ondartede sygdomme eller personer, der på anden måde er immunkompromitterede eller personer, der får immunsupprimerende behandling.
Rotarix should be administered with caution to individuals with immunodeficient close contacts, such as individuals with malignancies, or who are otherwise immunocompromised or individuals receiving immunosuppressive therapy.
Personer i kontakt med nylig vaccinerede, bør rådes til at overholde personlig hygiejne (f. eks. vaske deres hænder efter bleskift).
Contacts of recent vaccinees should observe personal hygiene (e. g. wash their hands after changing child’ s nappies).
Der opnås muligvis et lavere immunrespons og graden af klinisk beskyttelse er ubekendt.
Limited data in 140 premature children indicate that Rotarix can be given to premature children, however a lower immune response may be observed and the level of clinical protection remains unknown.
3 Da fordelene ved vaccination er stor for denne gruppe børn, bør vaccination ikke udelades eller forsinkes.
3 As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or delayed.
I kliniske undersøgelser, er der vist effekt mod gastro- enteritis forårsaget af rotavirus af typerne G1P[ 8], G2P[ 4], G3P[ 8], G4P[ 8] og G9P[ 8].
In clinical trials, efficacy was demonstrated against gastro-enteritis due to rotavirus of types G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8].
Graden af beskyttelse mod andre serotyper er ukendt.
The extent of protection that Rotarix might provide against other serotypes is unknown.
5. 1).
Clinical studies from which efficacy data were derived were conducted in Europe and Central and South America (see section 5.1).
Rotarix beskytter ikke mod gastro- enteritis forårsaget af andre patogener end rotavirus.
Rotarix does not protect against gastro-enteritis due to other pathogens than rotavirus.
Vaccinen indeholder hjælpestofferne saccharose og sorbitol.
The vaccine contains sucrose and sorbitol as excipients.
Denne vaccine bør ikke administreres til patienter med hereditær fructoseintolerans, glucosegalactosemalabsorption eller sucraseisomaltaseinsufficiens.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this vaccine.
Rotarix kan gives samtidigt med alle følgende monovalente eller kombinerede vacciner [inklusive hexavalente vacciner (DTPa- HBV- IPV/ Hib)]: difteri- tetanus- helcelle pertussis- vaccine (DTPw), diphtheria- tetanus- acellulær pertussis- vaccine (DTPa), Haemophilus influenzae type b- vaccine (Hib), inactiveret polio- vaccine (IPV), hepatitis B- vaccine (HBV), konjugeret pneumokok- vaccine og serotype C konjugeret meningokok- vaccine.
Rotarix can be given concomitantly with any of the following monovalent or combination vaccines [including hexavalent vaccines (DTPa-HBV-IPV/ Hib)]: diphtheria-tetanus-whole cell pertussis vaccine (DTPw), diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus influenzae type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), pneumococcal conjugate vaccine and meningococcal serogroup C conjugate vaccine.
Kliniske forsøg viste, at immunrespons og sikkerhedsprofiler af de administrerede vacciner var upåvirkede.
Clinical studies demonstrated that the immune responses and the safety profiles of the administered vaccines were unaffected.
Samtidig administration af Rotarix og oral polio- vaccine (OPV) påvirker ikke immunresponset overfor de forskellige polio- antigener.
Concominant administration of Rotarix and oral polio vaccine (OPV) does not affect the immune response to the polio antigens.
Selvom samtidig administration af OPV svagt kan nedsætte immunresponset overfor rotavirus- vaccine, blev den kliniske beskyttelse mod alvorlig rotavirus gastro- enteritis opretholdt i et klinisk forsøg med 4. 200 børn, som fik Rotarix samtidig med OPV.
Although concomitant administration of OPV may slightly reduce the immune response to rotavirus vaccine, clinical protection against severe rotavirus gastro-enteritis was shown to be maintained in a clinical trial involving more than 4200 subjects who received Rotarix concomitantly with OPV.
Der er ingen restriktioner med hensyn til barnets indtagelse af mad eller væske, inklusive brystmælk, hverken før eller efter vaccination.
There are no restrictions on the infant’ s consumption of food or liquid, either before or after vaccination.
Derfor er der ikke tilgængelige data for anvendelse under graviditet eller amning, og reproduktionsforsøg på dyr er ikke udført.
Thus human data on use during pregnancy or lactation are not available and animal reproduction studies have not been performed.
Baseret på evidens fra kliniske forsøg, reducerer amning ikke den beskyttelse mod rotavirus gastro - enterititis, som Rotarix forårsager.
Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against rotavirus gastro-enteritis afforded by Rotarix.
40. 200 børn.
4 In a total of eleven placebo-controlled clinical trials, approximately 77800 doses of Rotarix were administered to approximately 40200 infants.
I to kliniske forsøg (Finland) blev Rotarix administreret alene (administration af rutine børnevacciner blev forskudt).
In two clinical trials (Finland), Rotarix was administered alone (administration of routine paediatric vaccines was staggered).
Forekomsten af diaré, opkastning, tab af appetit, feber og irritabilitet i den gruppe, der fik Rotarix, var ikke forskellig fra den gruppe, der fik placebo.
The incidence of diarrhoea, vomiting, loss of appetite, fever and irritability was not different in the group receiving Rotarix when compared to the group receiving placebo.
Der sås ingen stigning i forekomst
No increase in the incidence or severity of these reactions was seen with the second dose.
I de ni andre kliniske førsøg (Europa, Canada, USA, Latinamerika, Singapore, Sydafrika) blev Rotarix administreret samtidigt med andre pædiatriske vacciner (se pkt.
In the remaining nine trials (Europe, Canada, USA, Latin America, Singapore, South-Africa), Rotarix was co-administered with routine paediatric vaccines (see section 4.5).
Bivirkningsprofilen hos disse børn var samstemmende med bivirkningsprofilen hos de børn, der fik de samme pædiatriske vacciner samt placebo.
The adverse reaction profile observed in these subjects was similar to the adverse reaction profile observed in subjects receiving the same paediatric vaccines and placebo.
Bivirkninger er anført herunder kategoriseret efter organklasse og hyppighed.
Adverse reactions are listed below per system organ class and frequency.
Hyppigheder rappoteres som:
Frequencies are reported as:
(≥ 1/ 10) (≥ 1/ 100 til, < 1/ 10) (≥ 1/ 1. 000 til, < 1/ 100) (≥ 1/ 10. 000 til, < 1/ 1. 000)
Very common (≥ 1/ 10) Common (≥ 1/ 100, < 1/ 10) Uncommon (≥ 1/ 1,000, < 1/ 100) Rare (≥ 1/ 10,000, < 1/ 1,000)
Søvnighed
Nervous system disorders Uncommon: somnolence
Hæshed, næseflåd
Respiratory, thoracic and mediastinal disorders Rare: hoarseness, rhinorrhoea
Forstoppelse
Gastrointestinal disorders Very common: loss of appetite Common: diarrhoea, vomiting, abdominal pain, flatulence, regurgitation of food Uncommon: constipation
Muskelkramper
Skin and subcutaneous tissue disorders Rare: dermatitis, rash
Infektion i øvre luftveje
Musculoskeletal and connective tissue disorders Rare: muscle cramp
Feber, træthed
Infections and infestations Rare: upper respiratory tract infection General disorders and administration site conditions Common: fever, fatigue
Søvnbesvær, gråd
Psychiatric disorders Very common: irritability Uncommon: sleep disorder, crying
Risikoen for invagination er undersøgt i en stor sikkerhedsundersøgelse udført i Latinamerika og Finland, hvor der indgik 63. 225 personer.
The risk of intussusception has been evaluated in a large safety trial conducted in Latin America and Finland where 63225 subjects were enrolled.
Denne undersøgelse viste, at der ikke er nogen øget risiko for invagination i Rotarixgruppen sammenlignet med placebogruppen som vist i tabellen nedenfor.
This trial gave evidence of no increased risk of intussusception in the Rotarix group when compared with the placebo group as shown in the table below.
Invagination inden 31
Intussusception within 31 days after administration of:
dage efter:
Rotarix N=31673
Rotarix (N = 31. 673)
Placebo N=31552
Placebo (N = 31. 552)
Relative risk (95% CI*)
Relativ
First dose
risiko (95% CI *)
2
Konfidensinterval
0.50 (0.07; 3.80)
1 5
5
2 5
5 5
0, 50 (0, 07; 3, 80) 0, 99 (0, 31; 3, 21)
0.99 (0.31; 3.21)