FrancophonIA/ELRC3.0 huggingface dataset:
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Rotarix, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Parents/guardians should be advised to promptly report such symptoms to their healthcare provider.
Danish: Forældre eller plejepersoner skal informeres om straks at give lægen besked, hvis sådanne symptomer forekommer.
English: The two doses of the vaccine must have been given by the age of 24 weeks, although they should preferably have been given before 16 weeks of age.
Danish: Begge doser skal være givet i 24-ugersalderen, dog helst inden 16-ugers-alderen.
English: LIST OF EXCIPIENTS Powder: sucrose, sorbitol See the package leaflet for further information
Danish: LISTE OVER HJÆLPESTOFFER Pulver: saccharose, sorbitol Læs indlægssedlen for yderligere information.
English: In three placebo-controlled clinical trials (Finland, India and Bangladesh), in which Rotarix was administered alone (administration of routine paediatric vaccines was staggered), the incidence and severity of the solicited events (collected 8 days post-vaccination), diarrhoea, vomiting, loss of appetite, fever, irritability and cough/runny nose were not significantly different in the group receiving Rotarix when compared to the group receiving placebo.
Danish: I tre placebokontrollerede kliniske studier (Finland, Indien og Bangladesh), hvor Rotarix blev administreret alene (rutinemæssige børnevaccinationer blev forskudt), var forekomsten og sværhedsgraden af de forventede bivirkninger set 8 dage efter vaccination (diaré, opkastning, appetitløshed, feber, irritabilitet og hoste/rinit) ikke væsentlig forskellig i den gruppe, der fik Rotarix, sammenlignet med den gruppe, der fik placebo.
English: Apnoea in very premature infants (≤ 28 weeks of gestation)
Danish: Apnø hos meget tidligt fødte børn (≤ 28 uger af svangerskabet) (se pkt.
English: Rotarix is available in a pack of 50 tubes.
Danish: Rotarix findes i pakninger á 50 tuber
English: 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.
Danish: Rotarix skal gives med forsigtighed til personer med pårørende, der har nedsat immunforsvar, såsom personer med maligne sygdomme eller personer, der på anden måde er immunkompromitterede eller personer, der får immunsupprimerende behandling.
English: 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 4,200 subjects who received Rotarix concomitantly with OPV.
Danish: Selvom samtidig administration af OPV svagt kan nedsætte immunresponset overfor rotavirus-vaccine, blev den kliniske beskyttelse mod alvorlige typer rotavirus-gastroenteritis opretholdt i et klinisk studie med flere end 4.200 børn, som fik Rotarix samtidig med OPV.
English: The safety profile presented below is based on data from clinical trials conducted with either the lyophilised or the liquid formulation of Rotarix.
Danish: Bivirkningsprofilen nedenfor er baseret på data fra kliniske studier med Rotarix, enten den frysetørrede eller den flydende formulering.
English: High Income countries
Danish: Højindkomstlande
English: Impact studies with Rotarix conducted in Panama, Brazil and Mexico showed a decrease in all-cause diarrhoea mortality ranging from 17% to 73% in children less than 5 years of age, within 2 to 4 years after vaccine introduction.
Danish: Indvirkningsstudier med Rotarix udført i Panama, Brasilien og Mexico viste et fald i total-mortalitet på grund af diarré på 17 % til 73 % hos børn under 5 år inden for 2-4 år efter introduktion af vaccinen.
English: These data are considered sufficient to support the inclusion of urticaria in section 4.8 of the SmPC with the frequency very rare, as the SmPC guideline recommends to list in section 4.8 all adverse reactions for which, after a thorough assessment, a causal relationship between the medicinal product and the adverse event is at least a reasonable possibility.
Danish: 4.8 i SmPC'et med hyppigheden meget sjælden, da SmPC-retningslinjerne anbefaler, at alle bivirkninger for hvilke, der efter grundig vurdering, findes i det mindste en rimelig mulighed for et årsagsforhold mellem lægemidlet og bivirkningen, nævnes under pkt.
English: Instructions for administration of the vaccine in a pre-filled oral applicator:
Danish: Instruktioner for administration af vaccinen i en fyldt oral applikator:
English: Put back in fridge immediately
Danish: Læg straks tilbage i køleskabet
English: It might be necessary to postpone the vaccination until recovery.
Danish: Det kan være nødvendigt at udsætte vaccinationen, indtil dit barn er raskt.
English: - This vaccine has been prescribed for your child only.
Danish: - Lægen har ordineret denne vaccine til dit barn.
English: Protective efficacy in Latin America
Danish: Beskyttende effekt i Latinamerika
English: Repeatedly flick the top of the tube until it is clear of any liquid
Danish: Knips gentagne gange på tubespidsen indtil den er fri for væske
English: Clinical studies have been conducted in Europe, Latin America, Africa and Asia to evaluate the protective efficacy of Rotarix against any and severe rotavirus gastro-enteritis.
Danish: Der er udført kliniske studier i Europa, Latinamerika, Afrika og Asien for at undersøge den beskyttende effekt af Rotarix mod hhv. enhver type rotavirus-gastroenteritis og mod alvorlige typer rotavirus-gastroenteritis.
English: 6.6 Special precautions for disposal and other handling The vaccine is presented as a clear, colourless liquid, free of visible particles, for oral administration.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Vaccinen er en klar, farveløs væske, fri for synlige partikler til oral administration.
English: Side effects that have been reported during marketed use of Rotarix include:
Danish: Bivirkninger, som er set efter markedsføring af Rotarix omfatter:
English: Pharmaco-therapeutic group: rotavirus diarrhoea vaccines, ATC code: J07BH01 Protective efficacy
Danish: Farmakoterapeutisk klassifikation: rotavirus-diaré-vacciner, ATC-kode: J07BH01 Beskyttende effekt
English: As a precaution, healthcare professionals should follow-up on any symptoms indicative of intussusception (severe abdominal pain, persistent vomiting, bloody stools, abdominal bloating and/or high fever) since data from observational safety studies indicate an increased risk of intussusception, mostly within 7 days after rotavirus vaccination (see section 4.8).
Danish: Sundhedspersonalet skal af sikkerhedmæssige årsager følge op på alle symptomer på invagination (svære abdominalsmerter, vedvarende opkastning, blod i afføringen, oppustet mave og/eller høj feber), da data fra observations-sikkerhedsstudier indikerer en øget risiko for invagination, oftest inden for 7 dage efter vaccination med Rotarix (se pkt.
English: The vaccine is presented as a clear, colourless liquid, free of visible particles, for oral administration.
Danish: Vaccinen er en klar, farveløs væske, fri for synlige partikler til oral administration.
English: Cases of transmission of this excreted vaccine virus to seronegative contacts of vaccinees have been observed without causing any clinical symptom.
Danish: Transmission af udskilt vaccinevirus til seronegative personer i kontakt med den vaccinerede er set uden, at det har medført nogen kliniske symptomer.
English: How Rotarix is given
Danish: Sådan gives Rotarix
English: Remove the plastic cover from the glass container containing the powder
Danish: Fjern plastikforseglingen fra glasbeholderen med pulver.
English: e.g., a person with cancer or who is taking medicines that may weaken the immune system.
Danish: Dette kan være personer, som har en kræftsygdom eller som tager medicin, der svækker immunforsvaret.
English: No data are available on the use of Rotarix for post-exposure prophylaxis.
Danish: Der er ingen tilgængelige data vedrørende anvendelse af Rotarix som profylakse efter eksponering.
English: Transfer the entire content of the oral applicator into the glass container containing the powder
Danish: Overfør hele den orale applikators indhold til glasbeholderen med pulver.
English: Squeezable tube
Danish: Blød tube
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF (DE) BIOLOGISK AKTIVE STOFFER OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: • Clear any liquid from the thinnest section of the tube by flicking just below the membrane.
Danish: • Fjern væsken fra den tyndeste del af tuben ved at knipse på stykket, lige under membranen.
English: Administer the vaccine
Danish: Administrer vaccinen
English: Instructions for administration of the vaccine in a squeezable tube: Please read the instructions for use all the way through before starting to give the vaccine.
Danish: Instruktioner for administration af vaccinen i en blød tube: Læs hele instruktionen, inden vaccinen administreres.
English: Administration of Rotarix should be postponed in subjects suffering from acute severe febrile illness.
Danish: Administration af Rotarix skal udsættes hos personer, som lider af sygdom med akut og alvorlig feber.
English: Vaccine efficacy during the first year of life progressively increased with increasing disease severity, reaching 100% (95% CI: 84.7;100) for Vesikari scores ≥17.
Danish: Effekten i første leveår stiger progressivt med stigende sværhedsgrad af sygdom, indtil 100 % (95 % CI: 84,7; 100) for Vesikari-score ≥ 17.
English: 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.
Danish: Rotarix kan gives samtidigt med alle følgende monovalente eller kombinerede vacciner [inklusive hexavalente vacciner (DTPa-HBV-IPV/Hib)]: difteri-tetanus-helcelle pertussis-vaccine (DTPw), difteri-tetanus-acellulær pertussis-vaccine (DTPa), Haemophilus influenzae type b-vaccine (Hib), inaktiveret polio-vaccine (IPV), hepatitis B-vaccine (HBV), konjugeret pneumokok-vaccine og serotype C konjugeret meningokok-vaccine.
English: If your child gets any of the side effects, talk to your doctor or pharmacist.
Danish: Hvis dit barn får bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: - The other ingredients in Rotarix are:
Danish: - Øvrige indholdsstoffer i Rotarix:
English: The administration of Rotarix should be postponed in subjects suffering from diarrhoea or vomiting.
Danish: Administration af Rotarix skal udsættes hos personer, der lider af diaré eller opkastning.
English: • Check the liquid is clear and colourless, without any particles in it.
Danish: • Tjek at væsken er klar og farveløs, og at der ikke er nogen partikler i den.
English: Oral applicator
Danish: Oral applikator
English: For instructions for the preparation or reconstitution of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om rekonstitution af lægemidlet før administration, se pkt.
English: This vaccine is for oral administration only.
Danish: Denne vaccine er kun til oral administration.
English: Circulating rotavirus strains
Danish: Cirkulerende rotavirusstammer
English: Protective efficacy in Africa
Danish: Beskyttende effekt i Afrika
English: 1 dose (1.5 ml)
Danish: 1 dosis (1,5 ml)
English: During the third year of life, there were no cases of severe RV gastro-enteritis in the Rotarix group (N=4,222) versus 13 (0.3%) in the placebo group (N=4,185).
Danish: I løbet af det tredje leveår var der ingen tilfælde af alvorlig rotavirus-gastroenteritis i Rotarix-gruppen (n = 4.222) versus 13 (0,3 %) i placebo-gruppen (n = 4.185).
English: Please read the instructions for use all the way through before starting to give the vaccine.
Danish: Læs venligst hele brugsanvisningen igennem, inden du begynder at give vaccinen.
English: - Multi-monodose (5 single dose) squeezable tube presentation connected by a bar: 2 years The vaccine should be used immediately after opening.
Danish: - Multi-enkeltdosis bestående af 5 sammenhængende enkeltdoser i bløde tuber: 2 år Vaccinen skal anvendes umiddelbart efter anbrud.
English: Rotarix contains sucrose and sorbitol
Danish: Rotarix indeholder saccharose og sorbitol
English: Protective efficacy in Europe
Danish: Beskyttende effekt i Europa
English: Do not use this vaccine after the expiry date which is stated on the carton.
Danish: Brug ikke vaccinen efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: (2) GSK sponsored studies (3) Data from a post-hoc analysis (4) Vaccine effectiveness was calculated using rotavirus-negative hospital control participants (estimates from
Danish: (2) GSK sponsorerede studier (3) Data fra en post-hoc-analyse (4) Vaccine-effektiviteten blev beregnet ved brug af rotavirus-negative hospitaliserede kontrolgruppedeltagere (estimater fra Taiwan blev beregnet ved kombineret rotavirus-negative hospitaliserede kontrolgruppedeltagere og hospitaliserede kontrolgruppedeltager uden diarré) (5) Vaccine-effektiviteten blev beregnet ved brug af nabokontrolgrupper.
English: PHARMACEUTICAL FORM AND CONTENTS Oral suspension
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Oral suspension
English: This vaccine is intended for oral administration only.
Danish: Denne vaccine er kun beregnet til oral administration.
English: The extent of protection that Rotarix might provide against other rotavirus strains that have not been circulating in clinical trials is currently unknown.
Danish: Graden af beskyttelse mod andre rotavirus-stammer, som ikke er undersøgt i kliniske studier, er på nuværende tidspunkt ukendt.
English: Gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency (SCID) disorder
Danish: Gastroenteritis med udskillelse af vaccinevirus hos børn med svær kombineret immundefekt (SCID)
English: Read the instructions before administration of the vaccine.
Danish: Læs vejledningen før administration af vaccinen.
English: • in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
Danish: • længere mellemrum mellem vejrtrækningerne hos meget for tidligt fødte børn (født i 28. svangerskabsuge eller tidligere) kan forekomme 2-3 dage efter vaccination.
English: If the reconstituted vaccine is to be stored temporarily before administration, replace the protective tip cap on the oral applicator.
Danish: Hvis den rekonstituerede vaccine skal opbevares midlertidigt, før den administreres, sættes beskyttelseshætten på den orale applikator.
English: A clinical study performed in Africa (Rotarix: N = 2,974; placebo: N = 1,443) evaluated Rotarix given at approximately 10 and 14 weeks of age (2 doses) or 6, 10 and 14 weeks of age (3 doses).
Danish: I et klinisk studie udført i Afrika (Rotarix: n = 2.974; placebo: n = 1.443) blev Rotarix administreret til børn omkring 10-ugers- og 14-ugers-alderen (2 doser) eller 6-, 10- og 14-ugers-alderen (3 doser).
English: Press the cap down to pierce the membrane.
Danish: Pres tubehætten ned for at perforere membranen.
English: • irritability
Danish: • irritabilitet.
English: In addition, nine impact studies on all-cause diarrhoea hospitalisation conducted in Africa and Latin America showed a reduction of 14% to 57% between 2 and 5 years after vaccine introduction.
Danish: Derudover viste ni indvirkningsstudier udført i Afrika og Latinamerika, omhandlende totalhospitalisering på grund af diarré, en reduktion på 14 % til 57 % mellem 2 og 5 år efter introduktion af vaccinen.
English: For instructions for administration, see section 6.6.
Danish: For instruktioner om administration, se pkt.
English: As with all vaccines, Rotarix may not completely protect all people who are vaccinated against the rotavirus infections it is intended to prevent.
Danish: Som for alle andre vacciner, giver Rotarix ikke alle vaccinerede børn fuld beskyttelse imod de rotavirus-infektioner, som den er beregnet til at forebygge.
English: Rotarix may be given at the same time your child receives other normally recommended vaccines, such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, oral or inactivated polio, hepatitis B vaccines as well as pneumococcal and meningococcal serogroup C conjugate vaccines.
Danish: Rotarix kan gives samtidigt med, at dit barn får andre anbefalede vacciner, så som vacciner mod difteri, stivkrampe, kighoste, Haemophilus influenzae type b, polio (oral eller inaktiveret), hepatitis B, samt konjugerede vacciner mod pneumokokker og meningokokker serotype C.
English: Human rotavirus RIX4414 strain (live, attenuated)*
Danish: Human rotavirus RIX4414 stamme (levende, svækket)*
English: • if your child was born with a malformation of the gut that could lead to intussusception.
Danish: • hvis dit barn har en medfødt misdannelse i tarmen, som kan medføre invagination.
English: Rotarix is supplied as a whitish powder in a single dose glass container and a separate oral applicator of solvent which contains a slow settling white deposit and a colourless supernatant.
Danish: Rotarix er et hvidligt pulver i et enkeltdosis glasbeholder og en separat oral applikator fyldt med solvens, som består af et langsomt bundfældende hvidt pulver og en farveløs ovenstående væske.
English: In a total of four clinical trials, approximately 3,800 doses of Rotarix liquid formulation were administered to approximately 1,900 infants.
Danish: I alt fire kliniske studier med ca. 3.800 doser Rotarix (flydende formulering) blev givet til ca. 1.900 spædbørn.
English: The reconstituted vaccine will appear more turbid than the solvent alone.
Danish: Den rekonstituerede vaccine vil fremstå mere uklar end solvensen alene.
English: * Not statistically significant (p ≥ 0.05).
Danish: * Ikke statistisk signifikant (p ≥ 0,05).
English: Grounds for the variation to the terms of the marketing authorisation(s) On the basis of the scientific conclusions for rotavirus vaccine monovalent (live, oral) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing rotavirus vaccine monovalent (live, oral) is unchanged subject to the proposed changes to the product information The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
Danish: På baggrund af de videnskabelige konklusioner for rotavirus-vaccine monovalent (levende, oral) er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder rotavirus-vaccine monovalent (levende, oral), forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: • Squeeze the liquid gently into the side of the child's mouth, towards the inside of their cheek.
Danish: • Pres roligt væsken ind i siden af barnets mund, mod indersiden af kinden.
English: The immunologic mechanism by which Rotarix protects against rotavirus gastro-enteritis is not completely understood.
Danish: Den immunologiske mekanisme, hvorved Rotarix virker mod rotavirus-gastroenteritis, er ikke fastlagt fuldstændigt.
English: The vaccine (1 ml liquid) will be given orally.
Danish: Vaccinen (1 ml væske) gives i munden.
English: In addition, efficacy against uncommon rotavirus genotypes G8P[4](severe gastro-enteritis) and G12P[6] (any gastro-enteritis) has been demonstrated.
Danish: Derudover blev der påvist effekt mod de ikke almindeligt forekommende rotavirus-genotyper G8P[4] (alvorlige typer gastroenteritis) og G12P[6] (enhver type gastroenteritis).
English: • Squeeze the liquid gently into the side of the child's mouth - towards the inside of their cheek.
Danish: • Pres roligt væsken ind i siden af barnets mund - mod indersiden af kinden.
English: Talk to your doctor/health care professional before your child receives Rotarix if:
Danish: Kontakt lægen eller sundhedspersonalet, før dit barn får Rotarix, hvis:
English: Instructions for administration of the vaccine:
Danish: Instruktioner for administration af vaccinen:
English: Connect the oral applicator into the transfer adapter by pushing it firmly on this device
Danish: Forbind den orale applikator med overførselsaggregatet ved et fast tryk på aggregatet.
English: The efficacy against severe RV gastro-enteritis requiring hospitalisation was 100% (95% CI: 72.4; 100).
Danish: Effekten mod alvorlig rotavirus-gastroenteritis, som krævede hospitalisering, var 100 % (95 % CI: 72,4; 100).
English: Human rotavirus RIX4414 strain (live, attenuated)
Danish: Human rotavirus RIX4414 stamme (levende, svækket)
English: Rotarix is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastroenteritis due to rotavirus infection (see sections 4.2, 4.4 and 5.1).
Danish: Rotarix er indiceret til aktiv immunisering af børn i alderen fra 6-24 uger til forebyggelse af gastroenteritis forårsaget af rotavirus-infektion (se pkt.
English: Any severity Severe†
Danish: Enhver type Alvorlige typer†
English: Position the cap to open the tube
Danish: Placering af tubehætten for at åbne tuben
English: Read the leaflet for the shelf-life of the reconstituted medicine.
Danish: Læs indlægssedlen for oplysninger om holdbarhed af det rekonstituerede lægemiddel EXP {MM/ÅÅÅÅ}
English: Low Income Countries
Danish: Lavindkomstlande
English: After the reconstitution, the vaccine should be administered immediately.
Danish: Efter rekonstituering skal vaccinen anvendes med det samme.
English: Vaccine efficacy was 100% (95% CI: 67.5; 100).
Danish: Effekten var 100 % (95 % CI: 67,5; 100).
English: The solvent is a turbid liquid with a slow settling white deposit and a colourless supernatant.
Danish: Solvensen er en uklar væske med et langsomt sættende hvidt bundfald og en farveløs supernatant.
English: Subjects with uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
Danish: Personer med ukorrigeret medfødt misdannelse af mave-tarmkanalen, som vil medføre prædisponering for invagination.
English: This product contains sucrose 9 mg and sorbitol 13.5 mg (see section 4.4).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Dette produkt indeholder 9 mg saccharose og 13,5 mg sorbitol (se pkt.
English: Ask your pharmacist how to throw away medicines your child no longer uses.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: The first dose may be given from the age of 6 weeks.
Danish: Første dosis kan gives fra 6-ugers-alderen.
English: Oral suspension in pre-filled oral applicator 1 pre-filled oral applicator 1 dose (1.5 ml)
Danish: Oral suspension i fyldt oral applikator 1 fyldt oral applikator 1 dosis (1,5 ml)
English: In a total of twenty-three clinical trials, approximately 106,000 doses of Rotarix (lyophilised or liquid formulation) were administered to approximately 51,000 infants.
Danish: Der er i treogtyve kliniske studier, administreret ca. 106.000 doser Rotarix (frysetørret pulver eller flydende formulering) til ca. 51.000 spædbørn.
English: After your child has received Rotarix, contact a doctor/health care professional right away if your child experiences severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever (see also section 4 “Possible side effects”).
Danish: Kontakt straks lægen eller sundhedspersonalet, hvis dit barn får alvorlige mavesmerter, vedvarende opkastning, blod i afføringen, oppustet mave og/eller høj feber efter at have fået Rotarix (se også afsnit 4 ”Bivirkninger”).