FrancophonIA/ELRC3.0 huggingface dataset:
English: Capecitabine Teva 150 mg film-coated tablets
Danish: Capecitabine Teva 150 mg filmovertrukne tabletter
English: Oval biconvex light peach film-coated tablets with inscription “C” on one side and “500” on the other side.
Danish: Capecitabine Teva 500 mg filmovertrukne tabletter Ovale, bikonvekse, lys ferskenfarvede filmovertrukne tabletter præget med “C” på den ene side og “500” på den anden.
English: What Capecitabine Teva is and what it is used for
Danish: Capecitabine Teva er indiceret som behandling af
English: -2nd appearance -3rd appearance
Danish: Ved 2. forekomst Ved 3. forekomst
English: A meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine monotherapy or capecitabine in combination with different chemotherapy regimens in multiple indications (colon, colorectal, gastric and breast cancer) showed that HFS (all grades) occurred in 2066
Danish: En metaanalyse af 14 kliniske studier med data fra mere end 4.700 patienter, som er blevet behandlet med capecitabin-monoterapi eller capecitabin i kombination med forskellige kemoterapiregimer indenfor flere indikationer (kolonkræft, kolorektalkræft, ventrikelkræft og brystkræft) viste, at håndog fodsyndrom (alle grader) forekom hos 2.066 (43 %) patienter gennemsnitligt 239 [95 % konfidensinterval 201, 288] dage efter behandlingsstart med capecitabin.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Capecitabine Teva is indicated for the treatment of: - for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer (see section 5.1).
Danish: - for den adjuverende behandling af patienter, som er opereret for stadium III (Dukes stadium C) kolonkræft (se pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Capecitabine Teva 150 mg film-coated tablets Each film-coated tablet contains 150 mg capecitabine.
Danish: Capecitabine Teva 150 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 150 mg capecitabin.
English: Hypersensitivity reaction, Hypoaesthesia
Danish: Hypokaliæmi, hyponatriæmi, hypomagnesiæmi, hypokalcæmi, hyperglycæmi
English: • shortness of breath, nose bleeds, cough, runny nose
Danish: • stakåndethed, næseblødninger, hoste, snue
English: 625 mg/m2
Danish: Reduceret dosis 625 mg/m2
English: Hypotension, Hot flush, Peripheral coldness
Danish: Dyb venethrombose, Hypertension, Petekkier, Hypotension, Hedeture, Perifer kuldefølelse
English: Capecitabine Teva 150 mg film-coated tablets Each film-coated tablet contains 15.6 mg lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Capecitabine Teva 150 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 15,6 mg lactose.
English: 950 mg/m2
Danish: Reduceret dosis 950 mg/m2
English: Jaundice
Danish: Hjerte
English: Alopecia, Nail disorder Hyperhidrosis, Rash erythematous,
Danish: Hyperhidrosis, erytematøst udslæt, urticaria, nattesved
English: Thrombophlebitis Deep vein thrombosis,
Danish: Thromboflebit is
English: Febrile neutropenia, Pancytopenia, Granulocytopenia, Thrombocytopeni a, Leukopenia, Haemolytic anaemia,
Danish: Febril neutropeni, Pancytopeni, Granulocytopeni
English: • liver failure
Danish: • leversvigt
English: • inflammation leading to dysfunction or obstruction in bile secretion (cholestatic hepatitis)
Danish: • betændelse med svigtende eller blokeret udskillelse af galde til følge
English: • fever, swelling in the limbs, feeling ill
Danish: • feber, hævede ben og arme, sygdomsfornemmelse
English: However, grade 3 or 4
Danish: 4.3 og 4.4).
English: NAME OF THE MEDICINAL PRODUCT Capecitabine Teva 150 mg film-coated tablets Capecitabine Teva 500 mg film-coated tablets
Danish: Capecitabine Teva 150 mg filmovertrukne tabletter Capecitabine Teva 500 mg filmovertrukne tabletter capecitabin
English: Capecitabine was at least equivalent to IV 5-FU/LV in disease-free survival in per protocol population (hazard ratio 0.92; 95% CI 0.80-1.06).
Danish: mht. sygdomsfri overlevelse i protokolpopulationen (hazard ratio 0,92; 95 % konfidensinterval 0,80-1,06).
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Alopeci, neglesygdomme
English: - EOF: epirubicin (50 mg/m2 as a bolus on day 1 every 3 weeks), oxaliplatin (130 mg/m2 given as a 2 hour infusion on day 1 every three weeks), and 5-FU (200 mg/m daily given by continuous infusion via a central line).
Danish: - ECX: epirubicin (50 mg/m2 som bolus på dag 1 hver 3. uge), cisplatin (60 mg/m2 som en totimers infusion på dag 1 hver 3. uge) og capecitabin (625 mg/m2 to gange dagligt givet kontinuerligt) - EOF: epirubicin (50 mg/m2 som bolus på dag 1 hver 3. uge), oxaliplatin (130 mg/m2 som en totimers infusion på dag 1 hver 3. uge) og 5-FU (200 mg/m2 dagligt givet som kontinuerlig infusion via en central linje).
English: Reduced dose
Danish: Nedsat appetit
English: Musculoskeletal stiffness, Muscular weakness
Danish: Hævelse af led, Knoglesmerter, Ansigtssmerter, Muskuloskeletal stivhed,
English: Do not smoke or eat while handling the product.
Danish: Der må ikke ryges og spises samtidig med håndtering af produktet.
English: Young Pigs:
Danish: Unge grise:
English: Sarcoptes scabiei var. suis
Danish: Skabmider: Sarcoptes scabiei var. suis
English: Additional Information
Danish: YDERLIGERE INFORMATION
English: Take care to avoid self-administration: the product may cause local irritation and/or pain at the site of injection.
Danish: Pas på selv-administration: produktet kan forårsage lokal-irritation og/eller smerte på injektionsstedet.
English: 5.8 Overdose
Danish: 5.8 Overdosering
English: Do not administer Porcimectin Injection during the first 40 days of pregnancy.
Danish: Anvend ikke Porcimectin Injection i løbet af de første 40 dage af drægtighedsperioden.
English: Haematopinus suis
Danish: Lus: Haematopinus suis
English: Replace with a fresh sterile needle after every 10 to 12 animals.
Danish: Nålen udskiftes med en ny, steril nål for hver 10 til 12 dyr.
English: The recommended route of administration is by subcutaneous injection into the neck.
Danish: Den anbefalede administrationsmåde er subkutan injektion i nakken.
English: Ivermectin is a member of the avermectin group.
Danish: Ivermectin tilhører avermectin-gruppen.
English: In young pigs, especially those below 16 kg for which less than 0.5 ml Porcimectin Injection is indicated, dosing accuracy is important.
Danish: Hos unge grise, specielt under 16 kg, hvor > 0,5 ml Porcimectin Injection er indikeret, er nøjagtig dosering vigtig.
English: Porcimectin Injection is indicated for the effective treatment and control of the following harmful parasites of pigs:
Danish: Porcimectin Injection er indikeret behandling og kontrol af følgende skadelige parasitter hos svin:
English: Multidose high density polyethylene bottles of 50 ml, 250 ml and 500 ml sealed with bromobutyl seals and aluminium overseals, containing a clear, colourless sterile solution.
Danish: Multidosis tætte polyethylen-flasker på 50 ml, 250 ml og 500 ml lukket med bromobutyl propper og aluminium forsegling, indeholdende en klar, farveløs steril opløsning.
English: This is equivalent to 1 ml per 33 kg bodyweight.
Danish: Dette svarer til 1 ml pr. 33 kg legemsvægt.
English: At a dose level of 0.3 mg ivermectin per kg bodyweight, a mean Cmax of 6.94 ng/ml was reached at a mean Tmax of 86.75 hours, and the mean elimination half life was 133.56 hours.
Danish: Ved dosering af 0,3 mg ivermectin pr. kg legemsvægt opnåedes et Cmax-gennemsnit på 6,94 ng/ml ved et Tmax-gennemsnit på 86,75 timer, og den gennemsnitlige halveringstid var 133,56 timer.
English: While the major single component excreted was unaltered drug, the major metabolite in swine are 3'' -O-desmethyl-H2B1a and 3'' -O-desmethyl-H2B1b.
Danish: Metaboliseringerne i svin er normalt 3'' -O-desmethyl-H2B1a og 3'' -O-desmethyl-H2B1b.
English: 5.9 Special Warnings for each Target Species
Danish: 5.9 Særlige advarsler for hver dyreart
English: Marketing Authorisation Number
Danish: Markedsføringstilladelse nr.:
English: 5.11 Special Precautions to be taken by the person administering the product to animals
Danish: 5.11 Særlige forsigtighedsregler for den person, som administrerer produktet
English: A dose of 30 mg ivermectin per kg (100 x the recommended dose of 0.3 mg per kg) injected subcutaneously to pigs caused lethargy, ataxia, bilateral mydriasis, intermittent tremors, laboured breathing and lateral recumbency.
Danish: En dosis på 30 mg ivermectin pr. kg (100 gange den anbefalede dosis på 0,3 mg pr. kg) injiceret subkutant forårsagede sløvhed, ataxi, bilateral mydriasis, periodisk skælven, anstrengt vejrtrækning, og lateral liggende stilling.
English: Gastrointestinal roundworms: (Adults and fourth stage larvae):
Danish: Gastrointestinale rundorme (Voksne og fjerde stadie larver):
English: Porcimectin Injection for pigs can be used in breeding sows and boars and will not affect fertility.
Danish: Porcimectin Injection til svin kan anvendes til avlssøer og orner og vil ikke påvirke fertiliteten.
English: Meat: 28 days
Danish: Slagtesvin: 28 dage.
English: Each ml contains 10 mg of ivermectin sufficient to treat 33 kg of bodyweight of pigs.
Danish: Hver ml indeholder 10 mg ivermectin, hvilket er tilstrækkeligt til behandling af 33 kg legemsvægt.
English: 5.2 Contra-indications
Danish: 5.2 Kontra-indikationer
English: NAME OF VETERINARY MEDICINAL PRODUCT Porcimectin Injection, 1%, Solution for Injection for swine
Danish: SPECIALITETENS NAVN Porcimectin Injection, 1 % injektionsvæske, opløsning, til svin
English: Porcimectin Injection can be used concurrently without adverse effects with foot and mouth disease vaccine or clostridial vaccine, given at separate injection sites.
Danish: Porcimectin Injection kan uden bivirkninger anvendes samtidig med vacciner mod mund- og klovsyge eller clostridier forudsat separate injektionssteder.
English: Metastrongylus spp.
Danish: Lungeorm: Metastrongylus spp.
English: Hyostrongylus rubidus
Danish: Ascaris suum Hyostrongylus rubidus
English: 5.10 Withdrawal Periods
Danish: 5.10 Tilbageholdelsestider:
English: Porcimectin Injection for Pigs has been formulated specifically for use in this species.
Danish: Porcimectin Injection til svin er formuleret specielt til brug hos svin.
English: 5.5 Use During Pregnancy and Lactation:
Danish: 5.5 Drægtighed og diegivning:
English: Porcimectin Injection for pigs can be given to all ages of animals including piglets.
Danish: Porcimectin Injection til svin kan anvendes til alle aldersklasser af svin, inklusive pattegrise.
English: Strongyloides ransomi (adults and somatic larval stages) Lungworms:
Danish: Strongyloides ransomi (voksen og somatisk larvestadie)
English: Therefore, the CVMP has recommended the granting of the Marketing Authorisation(s) for which the Summary of Product Characteristics is set out in Annex III for Porcimectin injection.
Danish: Derfor har CVMP anbefalet, at der udstedes markedsføringstilladelse(r) for Porcimectin injection.
English: If using a single-dose hypodermic syringe, use a separate sterile needle to withdraw Porcimectin Injection from the container.
Danish: Såfremt der anvendes en enkeltdosis hypodermisk kanyle bør Porcimectin Injection trækkes op fra beholderen ved brug af en separat steril nål.
English: All these reactions disappeared without treatment 5.4 Special Precautions for Use
Danish: Disse reaktioner forsvandt uden behandling.
English: Belgium Porcimec P 1 % w/v (10 mg/ml)
Danish: Porcimec P 1 % w/v (10 mg/ml)
English: The use of a syringe that can accurately deliver as little as 0.1 ml is recommended.
Danish: Det anbefales at anvende en sprøjte, der måler i enheder helt ned til 0,1 ml.
English: In pigs, the recommended dosage level is 300 mcg ivermectin per kg bodyweight.
Danish: Anbefalet dosis til svin er 0,3 mg ivermectin pr. kg legemsvægt.
English: 6.6 Special Precautions for the disposal of unused product or waste material, if any
Danish: 6.6 Særlige forsigtighedsregler vedrørende bortskaffelse af rester eller evt. affald Bortskaffelse af ubrugte veterinærprodukter og restprodukter skal ske i overensstemmelse med gældende lovgivning.
English: 6.3 Special Precautions for Storage None.
Danish: 6.3 Særlige opbevaringsforhold
English: 4.1 Pharmacodynamic properties
Danish: 4.1 Farmakologiske egenskaber
English: 5.3 Undesirable Effects
Danish: 5.3 Bivirkninger
English: 5.1 Indications For Use
Danish: 5.1 Indikationer
English: Mild and transient pain reactions may be seen in some pigs following subcutaneous injection at injection site.
Danish: Forbigående ubehag er blevet observeret på injektionsstedet hos enkelte dyr efter subkutan injektion.
English: CLINICAL PARTICULARS 5.0 Target Species: Pigs
Danish: 5.0 Dyrearter
English: Bimeda, (a division of Cross Vetpharm Group Limited) Broomhill Road, Tallaght, Dublin 24,
Danish: Bimeda, (Cross Vetpharm Group Limited)
English: Ireland.
Danish: Ingen.
English: 6.2 Shelf-life
Danish: 5.7 Dosering
English: IRELAND
Danish: Medlemsstat
English: Biliary excretion, followed by elimination in faeces is probably the major route of ivermectin excretion in pigs.
Danish: Hos svin udskilles ivermectin fortrinsvis via galden efterfulgt af udskillelse gennem fæces.
English: 5.6 Interaction with Other Medicaments and other Forms of Interactions
Danish: 5.6 Interaktioner
English: Mange mites:
Danish: Ud fra følgende betragtninger:
English: PHARMACEUTICAL FORM Solution for injection
Danish: LÆGEMIDDELFORM Injektionsvæske, opløsning.
English: The marketing authorisation was renewed on 10 February 2002 and on 10 February 2007.
Danish: Markedsføringstilladelsen blev fornyet den 10. februar 2002 og den 10. februar 2007.
English: The additional studies showed that the presence of antibodies was maintained for at least four years.
Danish: De supplerende undersøgelser viste, at tilstedeværelsen af antistoffer blev fastholdt i mindst fire år.
English: This means that the viruses and surface antigens are fixed onto aluminium compounds, to stimulate a better response.
Danish: Dvs. at vira og overfladeantigener er bundet til aluminiumsforbindelser for at fremkalde en bedre reaktion.
English: The only difference between the two vaccines is the amount of vaccine in each vial or syringe.
Danish: Den eneste forskel mellem de to vacciner er mængden af vaccine i hvert hætteglas eller hver injektionssprøjte.
English: It is used in infants, children and adolescents aged between one and 15 years who are not already immune to these two diseases and who are at risk of contracting both of them.
Danish: Den anvendes til spædbørn, børn og unge på mellem 1 og 15 år, som ikke allerede er immune over for disse to sygdomme, og som er i risiko for at få dem. Lægemidlet udleveres kun efter recept.
English: Two studies were carried out in a total of 180 children and adolescents, all of whom received Twinrix Paediatric.
Danish: Der blev foretaget to undersøgelser med i alt 180 børn og unge, der alle fik Twinrix Pædiatrisk.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Danish: Vacciner fungerer ved at lære kroppens naturlige forsvar, også kaldet immunsystemet, hvordan det forsvarer sig mod en sygdom.
English: The recommended vaccination schedule for Twinrix Paediatric is three doses with a gap of one month between the first two doses and a gap of five months between the second and third.
Danish: Det anbefalede vaccinationsprogram for Twinrix Pædiatrisk er tre doser med en måneds mellemrum mellem de to første doser og fem måneders mellemrum mellem den anden og tredje dosis.
English: Further studies looked at the persistence of antibody levels after vaccination.
Danish: I yderligere undersøgelser så forskerne nærmere på persistensen af antistofmængden efter vaccinationen.
English: The main measure of effectiveness was the proportion of the children who had developed protective levels of antibodies to hepatitis A and hepatitis B.
Danish: Det primære mål for virkning var andelen af børn, der udviklede beskyttende niveauer af antistoffer mod hepatitis A og hepatitis B.
English: It should be given by injection into the muscle of the upper arm or the thigh.
Danish: Vaccinen skal gives som en injektion i musklen på overarmen eller i låret.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TWINRIX PAEDIATRIC EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) TWINRIX PÆDIATRISK EPAR - sammendrag for offentligheden
English: The European Commission granted a marketing authorisation valid throughout the EU to GlaxoSmithKline Biologicals s.a. for Twinrix Paediatric on 10 February 1997.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Twinrix Pædiatrisk til GlaxoSmithKline Biologicals s.a. den 10. februar 1997.
English: It is available in a 0.5 ml vial and in a 0.5 ml prefilled syringe.
Danish: Den fås i hætteglas med 0,5 ml og som en fyldt injektionssprøjte med 0,5 ml.
English: When a person is given the vaccine, the immune system recognises the viruses and surface antigens as ‘foreign' and makes antibodies against them.
Danish: Når en person bliver vaccineret, opfatter immunsystemet virus og overfladeantigener som fremmede og danner antistoffer mod dem.
English: All children had satisfactory antibody levels to hepatitis A by two months, and almost 100% had protective levels of antibodies to hepatitis B by six months (just before the third vaccine dose).
Danish: Alle børnene opnåede tilfredsstillende mængder af antistoffer mod hepatitis A efter to måneder, og næsten 100 % opnåede beskyttende mængder af antistoffer mod hepatitis B efter seks måneder lige før den tredje dosis vaccine.
English: The studies showed that Twinrix Paediatric produced an immune response that was at least as good as that seen during studies of Twinrix Adult.
Danish: Undersøgelserne viste, at Twinrix Pædiatrisk frembragte en immunreaktion, der var mindst lige så god som den reaktion, der blev set i undersøgelserne af Twinrix Voksen.
English: Levels of antibodies to both hepatitis A and B increased after the third dose of the vaccine.
Danish: Niveauerne af antistoffer mod hepatitis A og B steg efter den tredje dosis vaccine.
English: Twinrix Paediatric is identical to the vaccine Twinrix Adult, which has been available in the European Union (EU) since 1996.
Danish: Twinrix Pædiatrisk er identisk med Twinrix Voksen-vaccinen, der har kunnet fås i EU siden 1996.
English: The most common side effect with Twinrix Paediatric (seen in more than 1 in 10 doses of the vaccine) is pain and redness at the injection site.
Danish: Den almindeligste bivirkning ved Twinrix Pædiatrisk (set ved flere end 1 ud af 10 doser vaccine) er ømhed og rødme omkring injektionsstedet.
English: Twinrix Paediatric should not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to neomycin (an antibiotic).
Danish: Twinrix Pædiatrisk bør ikke anvendes af personer, der kan være overfølsomme over for et af de aktive stoffer, et af de øvrige indholdsstoffer eller antibiotikummet neomycin.
English: The active substances in Twinrix Paediatric and Twinrix Adult have been available in the EU for a number of years in separate vaccines: Havrix Adult for protection against hepatitis A and Engerix-B for protection against hepatitis B.
Danish: Det aktive stof i Twinrix Pædiatrisk og Twinrix Voksen har kunnet fås i EU i en årrække i forskellige vacciner, f.eks. Havrix Voksen til beskyttelse mod hepatitis A og Engerix-B til beskyttelse mod hepatitis B.
English: It is recommended that individuals who receive the first dose should complete all three doses of Twinrix Paediatric.
Danish: Det anbefales, at personer, der får den første dosis, gennemfører hele tredosisprogrammet med Twinrix Pædiatrisk.
English: A booster dose of Twinrix Paediatric, or of a separate hepatitis A or B vaccine may be given, according to official recommendations.
Danish: Der kan gives en boosterdosis (forstærkningsdosis) af Twinrix Pædiatrisk eller af en separat vaccine mod hepatitis A eller B i overensstemmelse med officielle anbefalinger.
English: It contains inactivated (killed) hepatitis A viruses and parts of the hepatitis B virus as active substances.
Danish: Den indeholder som aktive stoffer inaktiveret (dræbt) hepatitis A-virus og dele af hepatitis B-virus.
English: Twinrix Paediatric is a vaccine, which is available as a suspension for injection.
Danish: Twinrix Pædiatrisk er en vaccine, der fås som en suspension til injektion.
English: Twinrix Paediatric is a vaccine.
Danish: Twinrix Pædiatrisk er en vaccine.
English: Other information about Twinrix Paediatric:
Danish: Andre oplysninger om Twinrix Pædiatrisk:
English: The full EPAR for Twinrix Paediatric can be found here.
Danish: Den fuldstændige EPAR for Twinrix Pædiatrisk findes her.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Twinrix Paediatric's benefits are greater than its risks for use in non-immune infants, children and adolescents from one year up to and including 15 years who are at risk of both hepatitis A and hepatitis B infection.
Danish: Udvalget for Humanmedicinske Lægemidler konkluderede, at fordelene ved Twinrix Pædiatrisk opvejer risiciene ved anvendelse til ikke-immune spædbørn, børn og unge fra 1 år til og med 15 år, som har risiko for at få en infektion med hepatitis A og hepatitis B. Udvalget anbefalede udstedelse af markedsføringstilladelse for Twinrix Pædiatrisk.
English: Twinrix Paediatric is used to protect against hepatitis A and hepatitis B infection (diseases that affect the liver).
Danish: Twinrix Pædiatrisk anvendes til at beskytte mod infektion med hepatitis A og hepatitis B, der begge er sygdomme, som påvirker leveren.
English: Twinrix Paediatric contains small amounts of inactivated hepatitis A viruses and the ‘surface antigen' (proteins from the surface) of the hepatitis B virus.
Danish: Twinrix Pædiatrisk indeholder små mængder af inaktiverede hepatitis A-virus og proteiner fra overfladen af hepatitis B-virus, såkaldte overfladeantigener.
English: For the full list of all side effects reported with Twinrix Paediatric, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Twinrix Pædiatrisk fremgår af indlægssedlen.
English: The surface antigens of the hepatitis B virus are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Danish: Dvs. at de dannes af en gærart, der har fået indsat et gen (dna), som gør den i stand til at producere proteinerne.
English: What is the risk associated with Twinrix Paediatric?
Danish: Hvilken risiko er der forbundet med Twinrix Pædiatrisk?
English: It should also not be used in people who have had an allergic reaction after being given hepatitis A or hepatitis B vaccines.
Danish: Den bør heller ikke anvendes til personer, der har haft en overfølsomhedsreaktion, efter de har fået en vaccine mod hepatitis A eller hepatitis B. Vaccination med Twinrix Pædiatrisk skal udskydes hos patienter med pludseligt opstået, alvorlig feber.
English: The antibodies will help to protect against diseases caused by these viruses.
Danish: Når immunsystemet efterfølgende udsættes for disse vira, vil det være i stand til hurtigere at danne antistoffer mod dem. Antistofferne hjælper med at beskytte mod de sygdomme, der fremkaldes af disse vira.
English: Why has Twinrix Paediatric been approved?
Danish: Hvorfor blev Twinrix Pædiatrisk godkendt?
English: Because Twinrix Paediatric and Twinrix Adult contain identical ingredients, some of the data used to support the use of Twinrix Adult were used to support the use of Twinrix Paediatric.
Danish: Nogle af de oplysninger, der forelå til støtte for anvendelsen af Twinrix Voksen, blev også anvendt til Twinrix Pædiatrisk, da Twinrix Pædiatrisk og Twinrix Voksen har de samme indholdsstoffer.
English: What is Twinrix Paediatric?
Danish: Hvad er Twinrix Pædiatrisk?
English: How has Twinrix Paediatric been studied?
Danish: Hvordan blev Twinrix Pædiatrisk undersøgt?
English: What is Twinrix Paediatric used for?
Danish: Hvad anvendes Twinrix Pædiatrisk til?