FrancophonIA/ELRC3.0 huggingface dataset:
English: This summary was last updated in 02-2008.
Danish: Dette sammendrag blev sidst ajourført i 02-2008.
English: Their breathing should be monitored for up to three days after vaccination.
Danish: Deres vejrtrækning bør overvåges i op til tre dage efter vaccinationen.
English: This helps to protect against the diseases that these bacteria and viruses cause.
Danish: Dette bidrager til at beskytte mod de sygdomme, som disse bakterier og vira kan fremkalde.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Danish: Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede de gennemførte undersøgelser og nåede frem til sine anbefalinger om, hvordan lægemidlet skal
English: The vaccine must only be given by injection into a muscle.
Danish: Vaccinen må kun gives ved injektion i en muskel.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PROCOMVAX
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) PROCOMVAX
English: PROCOMVAX is a combination of components that have been available in the European Union (EU) in other vaccines for a number of years.
Danish: PROCOMVAX er en kombination af komponenter, der har været tilgængelige i Den Europæiske Union (EU) i andre vacciner i en årrække.
English: for PROCOMVAX on 7 May 1999.
Danish: den 7. maj 1999.
English: The European Commission granted a marketing authorisation valid throughout the EU to Sanofi Pasteur MSD S.N.C.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for PROCOMVAX til Sanofi Pasteur MSD S.N.C.
English: PROCOMVAX has been studied in one main study involving 882 infants.
Danish: PROCOMVAX blev undersøgt i én hovedundersøgelse, hvori 882 spædbørn deltog.
English: However, the company provided further information from other studies to show that three doses of PROCOMVAX produced adequate levels of protection.
Danish: Virksomheden fremlagde imidlertid yderligere oplysninger fra andre undersøgelser, der viste, at tre doser af PROCOMVAX medførte en tilstrækkelig beskyttelse.
English: In both groups, the infants were vaccinated at two, four, and 12 to 15 months of age.
Danish: I begge grupper blev spædbørnene vaccineret ved alderen to, fire og 12-15 måneder.
English: Infants who show signs of hypersensitivity (allergic reaction) after an injection should not receive further injections of the vaccine.
Danish: Spædbørn, der fremviser tegn på overfølsomhed (allergisk reaktion) efter en injektion, bør ikke gives flere injektioner af vaccinen.
English: The Committee recommended that PROCOMVAX be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for PROCOMVAX.
English: This conclusion was confirmed with the results from seven additional studies supplied by the company.
Danish: Resultaterne fra syv andre undersøgelser, som virksomheden indsendte, bekræftede denne konklusion.
English: These 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: De fremstilles ved hjælp af en metode, der kaldes rekombinant dna-teknologi: Det vil sige, at de dannes af en gærart, der har fået indsat et gen (dna), som gør den i stand til at producere proteinerne.
English: PROCOMVAX should not be used in infants who may be hypersensitive (allergic) to any of the active substances or any of the other ingredients.
Danish: PROCOMVAX bør ikke anvendes hos spædbørn, der kan være overfølsomme (allergiske) over for de aktive stoffer eller andre af indholdsstofferne.
English: PROCOMVAX contains small amounts of:
Danish: PROCOMVAX indeholder små mængder
English: The study compared the effects of PROCOMVAX with those of separate vaccines containing the same active substances.
Danish: I undersøgelsen sammenlignedes virkningen af PROCOMVAX med virkningen af separate vacciner med de samme aktive stoffer.
English: PROCOMVAX is not recommended for infants younger than six weeks of age, because of a risk of a reduced protective response to Hib.
Danish: PROCOMVAX anbefales ikke til spædbørn under seks uger på grund af risikoen for reduceret beskyttelse mod Hib.
English: The active substances are ‘adsorbed', meaning that they are fixed onto aluminium compounds, and the vaccine contains an ‘adjuvant' (a compound containing aluminium) to stimulate a better response.
Danish: De aktive stoffer er adsorberede, hvilket vil sige, at de er bundet til aluminiumsforbindelser, og vaccinen indeholder en adjuvans, der er et stof, som indeholder aluminium, for at fremme en bedre reaktion.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Danish: Vacciner fungerer ved at lære kroppens naturlige forsvar, også kaldet immunsystemet, hvordan det forsvarer sig mod sygdomme.
English: Other common side effects are fever, anorexia (loss of appetite), vomiting, diarrhoea, irritability, somnolence (sleepiness), crying (including unusual highpitched crying and prolonged crying) and otitis media (infection of the middle ear).
Danish: Andre hyppige bivirkninger er feber, appetitløshed, opkastning, diarré, irritabilitet, søvntrang, gråd (herunder usædvanlig skinger og langvarig gråd) og mellemørebetændelse.
English: PROCOMVAX is a vaccine, which is available as a suspension for injection.
Danish: PROCOMVAX er en vaccine, der fås som en suspension til injektion.
English: The most common side effects seen with PROCOMVAX are reactions at the injection site, including pain, soreness, erythema (redness) and swelling.
Danish: De hyppigste bivirkninger ved PROCOMVAX er reaktioner på injektionsstedet, herunder smerte, ømhed, rødme og hævelse.
English: PROCOMVAX is a vaccine.
Danish: PROCOMVAX er en vaccine.
English: • a protein purified from Hib, attached to a carrier (a protein purified from the outer membrane of
Danish: • et protein, der er oprenset fra Hib og koblet til en bærer (et protein oprenset fra ydermembranen af
English: PROCOMVAX is used to vaccinate infants aged between six weeks and 15 months against ‘invasive' disease caused by Hib (such as bacterial meningitis) and infection with the hepatitis B virus.
Danish: PROCOMVAX anvendes til vaccination af spædbørn på mellem seks uger og 15 måneder mod ”invasiv” sygdom fremkaldt af Hib (f.eks. bakteriel meningitis) og infektion med hepatitis B-virussen.
English: Children who receive one dose of a hepatitis B vaccine at or shortly after birth can be given PROCOMVAX.
Danish: Børn, der får en dosis hepatitis B-vaccine ved fødslen eller kort tid derefter, kan vaccineres med PROCOMVAX.
English: The vaccination schedule is three doses of PROCOMVAX, ideally at two, four, and 12 to 15 months of age.
Danish: Vaccinationsprogrammet er tre doser PROCOMVAX, der helst skal gives ved to-, fire- og 12- til 15måneders-alderen.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that PROCOMVAX's benefits are greater than its risks for vaccination against invasive disease caused by Hib and against infection caused by all known subtypes of hepatitis B virus in infants six weeks to 15 months of age.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved PROCOMVAX er større end risiciene ved vaccination mod invasiv sygdom fremkaldt af Hib og mod infektion med alle kendte undertyper af hepatitis B-virus hos spædbørn i alderen seks uger til 15 måneder.
English: • surface antigen (proteins from the surface) of the hepatitis B virus.
Danish: • overfladeantigener, dvs. proteiner fra overfladen, fra hepatitis B-virussen.
English: How has PROCOMVAX been studied?
Danish: Hvordan blev PROCOMVAX undersøgt?
English: The main measure of effectiveness whether protective levels of antibodies to Hib and hepatitis B virus had developed at one and two months after vaccination.
Danish: Det primære mål for virkning var, om børnene havde udviklet beskyttende mængder af antistoffer mod Hib og hepatitis B-virus en og to måneder efter vaccinationen.
English: In the main study, the responses both to PROCOMVAX and to the separate vaccines were low in terms of levels of antibodies against Hib.
Danish: I hovedundersøgelsen var der en lav respons både på PROCOMVAX og de separate vacciner, når det gælder mængden af antistoffer mod Hib.
English: Vaccination with PROCOMVAX should be postponed in infants with moderate or severe sudden fever until they have recovered.
Danish: Vaccination med PROCOMVAX af spædbørn med moderat til svær pludselig feber bør udskydes, til
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger om baggrunden for CHMP's anbefalinger, kan du læse de faglige
English: The main study also showed that PROCOMVAX produced adequate levels of protection against hepatitis B virus.
Danish: Det blev også påvist i hovedundersøgelsen, at vaccination med PROCOMVAX medførte en tilstrækkelig beskyttelse mod hepatitis B-virus.
English: The results of further studies were used to support the use of PROCOMVAX, both in infants who had and who had not received hepatitis B vaccination in the past.
Danish: Resultaterne af yderligere undersøgelser blev anvendt til at støtte brugen af PROCOMVAX til både de spædbørn, der tidligere var blevet vaccineret mod hepatitis B, og dem, der ikke var.
English: What benefit has PROCOMVAX shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved PROCOMVAX?
English: When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses as ‘foreign' and makes antibodies against them.
Danish: Når et spædbarn bliver vaccineret, opfatter immunsystemet delene fra bakterierne og viraene som fremmede og danner antistoffer mod dem. Immunsystemet vil efterfølgende være i stand til at danne antistoffer langt hurtigere, når barnet på naturlig vis eksponeres for bakterierne eller viraene.
English: It contains proteins from Haemophilus influenzae type b (‘Hib', a bacterium that can cause meningitis) and parts of the hepatitis B virus as active substances.
Danish: De aktive stoffer i vaccinen er proteiner fra Haemophilus influenzae type b (”Hib”, en bakterie, som kan fremkalde meningitis) og
English: As for all vaccines, if PROCOMVAX is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Danish: Ligesom for andre vacciner gælder det for PROCOMVAX, at der er en risiko for apnø, dvs. korte pauser i vejrtrækningen, hvis vaccinen gives til spædbørn, der er født meget for tidligt.
English: For the full list of all side effects reported with PROCOMVAX, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved
English: The additional studies showed that protection against hepatitis B from PROCOMVAX was adequate in infants who had and who had not received hepatitis B vaccination in the past.
Danish: Det blev i de andre undersøgelser påvist, at den beskyttelse mod hepatitis B, som PROCOMVAX giver, var tilstrækkelig hos spædbørn, uanset om de tidligere var blevet vaccineret mod hepatitis B
English: The tmax was delayed by two hours.
Danish: Tmax blev forsinket i to timer.
English: Keep the bottle tightly closed.
Danish: Hold flasken tæt tillukket.
English: If you do get any of them, it is unlikely to be serious, but you need to check.
Danish: Hvis De får nogen af dem, er det sandsynligvis ikke alvorligt, men De er nødt til at få det kontrolleret.
English: Treatment discontinuation may be considered as follows:
Danish: Seponering af behandlingen kan overvejes som følger:
English: Date of first authorisation: 06 March 2003 Date of latest renewal: 06 March 2008
Danish: Dato for første markedsføringstilladelse: 06. marts 2003 Dato for seneste fornyelse: 06. marts 2008
English: As data becomes available
Danish: Som data bliver tilgængelige
English: You may need blood tests for several months after treatment.
Danish: Det kan være nødvendigt at tage blodprøver i flere måneder efter behandlingen.
English: • Take care not to infect other people.
Danish: • Pas på ikke at smitte andre mennesker.
English: The optimum duration of treatment is unknown.
Danish: Den optimale behandlingsvarighed er ukendt.
English: Exacerbation of hepatitis:
Danish: Forværring af hepatitis:
English: County Cork, T45 DP77 Ireland
Danish: County Cork, T45 DP77 Irland
English: Clinical efficacy and safety:
Danish: Klinisk virkning og sikkerhed:
English: • Tell your doctor immediately if you are pregnant or planning to become pregnant.
Danish: • Fortæl det omgående til Deres læge, hvis De er gravid eller planlægger at blive gravid.
English: • If you are over 65 years of age your doctor may monitor your health more closely.
Danish: • Hvis De er over 65 år, vil Deres læge muligvis kontrollere Deres helbred særligt omhyggeligt.
English: Wait and take the next dose at the regular time.
Danish: Vent og tag den næste dosis til sædvanlig tid.
English: Side effects before or after having a liver transplant
Danish: Bivirkninger før eller efter en levertransplantation
English: These patients should be followed closely.
Danish: Disse patienter bør følges nøje.
English: People with liver disease may also be at risk.
Danish: Mennesker med leversygdom kan også være udsat for risiko.
English: Elderly: The clinical experience in patients > 65 years of age is very limited.
Danish: Ældre: Den kliniske erfaring med patienter > 65 år er meget begrænset.
English: Improvement in liver function was also seen after one year of therapy.
Danish: Forbedring af leverfunktion blev også set efter 1 års terapi.
English: Do not take a double dose (two doses close together).
Danish: De må ikke tage en dobbeltdosis (to doser kort tid efter hinanden).
English: • If you are HIV positive this medicine will not control your HIV infection.
Danish: • Hvis De er hiv-positiv, kan denne medicin ikke kontrollere Deres hiv-infektion.
English: • A different dose may be given to patients with kidney problems.
Danish: • Der kan gives en anden dosis til patienter med nyreproblemer.
English: The frequency of the following side effects is not known (frequency cannot be estimated from the available data):
Danish: Hyppigheden af følgende bivirkninger er ikke kendt (kan ikke estimeres ud fra de tilgængelige data):
English: Hepsera can be taken with or without food.
Danish: Hepsera kan tages med eller uden mad.
English: The risk of this occurring is increased with long-term use of Hepsera.
Danish: Risikoen for, at dette forekommer, bliver større ved langvarig anvendelse af Hepsera.
English: Pharmacokinetic studies were principally conducted in Caucasian patients.
Danish: Farmakokinetiske studier er primært blevet udført på kaukasiske patienter.
English: It is not known whether the active substance in this medicine passes into breast milk.
Danish: Man ved ikke, om det aktive stof i denne medicin går over i modermælken.
English: Some patients have experienced:
Danish: Nogle patienter har fået:
English: Your doctor should run tests to check your kidneys and liver are working properly, before and during your treatment.
Danish: Deres læge bør tage nogle prøver for at kontrollere, at Deres nyrer og lever fungerer ordentligt, før og under behandlingen.
English: It is important not to miss a dose.
Danish: Det er vigtigt ikke at springe en dosis over.
English: Higher doses must not be administered.
Danish: Højere doser må ikke gives.
English: Hepsera with food and drink
Danish: Brug af Hepsera sammen med mad og drikke
English: As adefovir is structurally related to nucleoside analogues, this risk cannot be excluded.
Danish: Da adefovir strukturelt er relateret til nukleosidanaloger, kan denne risiko ikke udelukkes.
English: Hepsera reduces the amount of the virus in your body, and has been shown to reduce liver damage.
Danish: Hepsera reducerer mængden af virus i kroppen og har vist sig at mindske skaderne på leveren.
English: 30 tablets.
Danish: 30 tabletter.
English: Hepsera belongs to a group of medicines called antiviral medicines.
Danish: Hepsera hører til en gruppe af medicin, som kaldes "antivirale lægemidler".
English: Increases in creatinine
Danish: Stigning i kreatinin
English: Magnesium stearate
Danish: Magnesiumstearat
English: Improvements or stabilisation were seen in Child-Pugh-Turcotte score.
Danish: Forbedringer eller stabilisering blev set i Child-Pugh-Turcotte's score.
English: It can cause too much lactic acid in the blood and enlargement of the liver.
Danish: Det kan føre til for meget mælkesyre i blodet og forstørrelse af leveren.
English: No patients became HBsAg- or HBeAg-negative during the study.
Danish: Ingen patienter blev HBsAg- eller HBeAg-negative i løbet af undersøgelsen.
English: It is not known whether Hepsera is safe to use during human pregnancy.
Danish: Man ved ikke, om Hepsera er sikkert at bruge, når man er gravid.
English: • your doctor should order blood tests every three months to check your medicine is keeping your chronic hepatitis B infection under control.
Danish: • bør Deres læge bestille blodprøver hver 3. måned for at holde øje med, at medicinen holder Deres kroniske hepatitis B-infektion under kontrol.
English: Hepsera can affect the way your kidneys work.
Danish: Hepsera kan påvirke den måde, nyrerne arbejder på.
English: • pentamidine, for other types of infection.
Danish: • pentamidin, mod andre typer infektion.
English: • Kidney problems, as shown by blood tests
Danish: • Nyreproblemer, ses ved blodprøver
English: • If it is nearly time for your next dose, skip the missed dose.
Danish: • Hvis det næsten er tid for den næste dosis, så spring den glemte dosis over.
English: The safety data derived from 5 pivotal randomized controlled studies, including a total of 1,174 patients, were reviewed.
Danish: Sikkerhedsdata udledt fra 5 pivotale randomiserede, kontrollerede studier, der inkluderede i alt 1.174 patienter, blev vurderet på ny.
English: EU/1/03/251/001 30 tablets EU/1/03/251/002 90 (3 bottles of 30) tablets
Danish: EU/1/03/251/001 30 tabletter EU/1/03/251/002 90 (3 bokse med 30) tabletter
English: Safety in patients with decompensated disease:
Danish: Sikkerhed hos patienter med dekompenseret sygdom:
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apotekspersonalet til råds, før De tager dette lægemiddel.
English: Depending on the results, your doctor may change how often you take Hepsera.
Danish: Afhængigt af resultaterne kan lægen ændre, hvor tit De skal tage Hepsera.
English: If you accidentally take too many Hepsera tablets, contact your doctor or nearest hospital immediately.
Danish: Hvis De er kommet til at tage for mange Hepsera-tabletter, så kontakt omgående Deres læge eller nærmeste hospital.
English: Five patients achieved and maintained HBsAg seroconversion (HBsAg negative/HBsAb positive).
Danish: Fem af patienterne opnåede og opretholdt HBsAg-serokonversion (HBsAg negativ/HBsAb positiv).
English: Patients should be monitored every six months for hepatitis B biochemical, virological and serological markers.
Danish: Patienter skal kontrolleres hver sjette måned for biokemiske, virologiske og serologiske hepatitis B markører.
English: • Do not take Hepsera if you are taking any medicines containing tenofovir.
Danish: • Tag ikke Hepsera, hvis De tager medicin indeholdende tenofovir.
English: common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100) or not known (identified through postmarketing safety surveillance and the frequency cannot be estimated from the available data).
Danish: Hyppigheder er defineret som meget almindelige (≥ 1/10), almindelige (≥ 1/100, < 1/10), ikke almindelige (≥ 1/1.000, < 1/100) eller ikke kendt (identificeret fra sikkerhedsovervågning efter markedsføring og frekvensen kan ikke estimeres ud fra forhåndenværende data).
English: Lactic acidosis occurs more often in women, particularly if they are very overweight.
Danish: Laktatacidose forekommer oftere hos kvinder, især hvis de er meget overvægtige.
English: On the basis of these data, the frequency of these adverse drug reactions is calculated to be 0.4% corresponding to the frequency category uncommon.
Danish: På grundlag af disse data beregnes frekvensen af disse bivirkninger til at være 0,4 %, svarerende til frekvenskategorien ikke almindelig.
English: With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuing the selected therapy remains appropriate for the patient.
Danish: Ved langvarig behandling i mere end 2 år tilrådes regelmæssig revurdering for at bekræfte, at det fortsat er hensigtsmæssigt for patienten at fortsætte den valgte behandling.
English: • Use an effective method of contraception to avoid becoming pregnant if you are a woman of child-bearing age taking Hepsera.
Danish: • Brug en effektiv præventionsmetode for at undgå at blive gravid, hvis De er kvinde, der kan få børn, og De tager Hepsera.
English: 90 (3 bottles of 30) tablets.
Danish: 90 (3 bokse med 30) tabletter.
English: • Do not use Hepsera in children or adolescents under 18 years of age.
Danish: • Hepsera må ikke anvendes til børn eller unge under 18 år.
English: If overdose occurs, the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary.
Danish: Såfremt der forekommer overdosering, skal patienten overvåges for tegn på toksicitet, og der skal gives støttende standardbehandling efter behov.
English: The available data do not appear to indicate any difference in pharmacokinetics with regard to race.
Danish: De foreliggende data synes ikke at angive nogen forskel i farmakokinetik med hensyn til race.
English: Cmax (ng/ml) AUC0-∞ (ng·h/ml) CL/F (ml/min) CLrenal (ml/min)
Danish: Cmax (ng/ml) AUC0-∞ (ng·t/ml) CL/F (ml/min) CLrenal (ml/min)
English: Paediatric population:
Danish: Pædiatrisk population:
English: Normalisation of ALT, albumin, bilirubin and prothrombin time was seen at week 48 in 51-85 % of the patients.
Danish: Normalisering af ALAT, albumin, bilirubin og protrombintid blev set ved uge 48 hos 51-85 % af patienterne.
English: Not all pack sizes may be marketed.
Danish: Begge pakningsstørrelser er ikke nødvendigvis markedsført.
English: Hepsera does not reduce the risk of passing on HBV to others through sexual contact or blood contamination.
Danish: Hepsera reducerer ikke risikoen for at smitte andre med HBV via seksuel kontakt eller blodkontamination.
English: A vaccine is available to protect those at risk from becoming infected with HBV.
Danish: Der findes en vaccine til at beskytte dem, der er udsat for at blive smittet med HBV.
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget studier af virkningen på evnen til at føre motorkøretøj og betjene maskiner.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: The adverse reactions considered at least possibly related to treatment are listed below, by body system organ class, and frequency (see Table 1).
Danish: Bivirkninger, som anses for at være i det mindste muligvis relateret til behandlingen, er anført nedenfor efter legemssystemorganklasse og hyppighed (se tabel 1).
English: Hepsera [outer packaging only]
Danish: Hepsera [kun på den ydre emballage]