FrancophonIA/ELRC3.0 huggingface dataset:
English: [For vancomycin powder for concentrate for solution for infusion for parenteral administration, the indications should be as follows:]
Danish: 4.1 Terapeutiske indikationer [Dette afsnit skal lyde som følger:] [For vancomycin pulver til koncentrat til infusionsvæske, opløsning til parenteral administration, skal indikationerne være som følger:]
English: except Clostridium innocuum
Danish: undtagen Clostridium innocuum Eubacterium spp.
English: However, in severe inflammation of the intestinal mucosa, especially in combination with renal insufficiency, side effects that occur when vancomycin is administered parenterally may appear.
Danish: Ved alvorlig betændelse i tarmslimhinden, især i kombination med nyreinsufficiens, kan der dog opstå bivirkninger, som forekommer ved parenteral administration.
English: [For parenteral formulations authorised for oral use:] Oral administration
Danish: [For parenterale formuleringer godkendt til oral anvendelse:] Oral indgivelse
English: Warnings and precautions Talk to your doctor or hospital pharmacist or nurse before using Vancomycin if: - You suffered a previous allergic reaction to teicoplanin because this could mean you are also allergic to vancomycin.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager <X>, hvis: - du tidligere har haft en allergisk reaktion over for teicoplanin, fordi det kan betyde, at du også er allergisk over for vancomycin - du har en hørelidelse, især hvis du er ældre (du skal muligvis have foretaget høreprøver under behandlingen) - du har en nyrelidelse (du skal have dit blod og dine nyrer undersøgt under behandlingen) - du, i stedet for oralt, får vancomycin ved infusion til behandling af diarré forbundet med infektion af bakterien Clostridium difficile.
English: Vancomycin is indicated in all age groups for the treatment of the following infections (see sections 4.2, 4.4 and 5.1): - complicated skin and soft tissue infections (cSSTI) - bone and joint infections - community acquired pneumonia (CAP) - hospital acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP) - infective endocarditis
Danish: [For vancomycin pulver til koncentrat til infusionsvæske godkendt til intravenøs anvendelse] Vancomycin anvendes til alle aldersgrupper ved infusion til behandling af følgende alvorlige betændelsestilstande: - betændelser i huden og i væv under huden - betændelser i knogler og led - lungebetændelse (også kaldet "pneumoni") - betændelse i hjertehinden (endocarditis) og for at forhindre endocarditis hos risikopatienter,
English: Infants and children aged from one month to less than 12 years of age: The recommended dose is 10 to 15 mg/kg body weight every 6 hours (see section 4.4).
Danish: Den anbefalede dosis er 10 til 15 mg/kg legemsvægt hver 6. time (se pkt.
English: PHARMACOLOGICAL PROPERTIES
Danish: 5.2 Farmakokinetiske egenskaber
English: [For parenteral formulations authorised for oral use, the indication should be as follows:] Oral administration
Danish: [For parenterale formuleringer, der er godkendt til oral anvendelse, skal indikationen være som følger:]
English: Intermittent haemodialysis Peritoneal dialysis
Danish: Intermitterende hæmodialyse Peritoneal dialyse Kontinuerlig nyreerstatningsbehandling
English: After oral administration, only a fraction of the administered dose is recovered in the urine.
Danish: [For parenterale formuleringer godkendt til oral anvendelse skal følgende ordlyd inkluderes:] Efter oral administration genfindes kun en del af den administrerede dosis i urinen.
English: Hypersensitivity reactions, anaphylactic reactions Ear and labyrinth disorders:
Danish: Overfølsomhedsreaktioner, anafylaktiske reaktioner
English: Dyspnoea, stridor Gastrointestinal disorders: Rare
Danish: Dyspnø, stridor
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apotekspersonalet.
English: - Sudden onset of severe allergic skin reaction with skin flaking blistering or peeling skin.
Danish: (hævede lymfeknuder), unormale blod- og leverfunktionstests - Udslæt med blærer og feber.
English: [For parenteral formulations authorised for intraperitoneal use, the indication should be as follows:] Intraperitoneal administration
Danish: [For parenterale formuleringer godkendt til intraperitoneal anvendelse, skal indikationen være som følger:]
English: If you get any side effects, talk to your doctor, hospital pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: If you have an inflammatory disorder of the digestive tract (you may be at risk of side effects, especially if you also have a kidney disorder).
Danish: • du lider af betændelse i mave-tarm-kanalen (der kan være risiko for, at du får bivirkninger,
English: - Being sick (throwing up), diarrhoea - Confusion, drowsiness, lack of energy, swelling, fluid retention, decreased urine - Rash with swelling or pain behind the ears, in the neck, groin, under the chin and armpits (swollen lymph nodes), abnormal blood and liver function tests - Rash with blisters and fever.
Danish: - Stakåndethed, støjende vejrtrækning (en høj lyd som følge af besværet luftgennemstrømning i de øvre luftveje) - Udslæt og betændelse i munden, kløe, kløende udslæt, nældefeber - Nyreproblemer, der primært kan påvises ved blodprøver - Rødmen på overkrop og ansigt, venebetændelse.
English: Cardiac arrest
Danish: Hjertestop
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section
Danish: Overfølsomhed overfor det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION [For all vancomycin 125 mg capsule] [The following wording to be reflected in this section] Each capsule contains 125mg vancomycin hydrochloride equivalent to 125,000IU vancomycin.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING [For alle vancomycin 125 mg kapsler]
English: Children aged from one month to less than 12 years of age The dosage will be calculated according to your body weight.
Danish: Doseringen vil blive beregnet i forhold til din legemsvægt.
English: - Loss of balance, ringing in your ears, dizziness - Blood vessel inflammation - Nausea (feeling sick) - Inflammation of the kidneys and kidney failure - Pain in the chest and back muscles - Fever, chills
Danish: Sjældne bivirkninger (kan forekomme hos 1 ud af 1.000 personer): - Fald i antallet af hvide blodlegemer, røde blodlegemer og blodplader (de blodlegemer, der er ansvarlige for, at blodet størkner) - Stigning i antallet af visse af de hvide blodlegemer i blodet - Tab af balanceevne, ringen for ørene, svimmelhed - Betændelse i blodkarrene - Kvalme - Betændelse i nyrerne og nyresvigt - Smerter i bryst- og rygmuskler - Feber, kulderystelser.
English: 12 months.
Danish: 12 måneder.
English: These side effects usually disappear within 1 to 2 days without treatment.
Danish: Disse bivirkninger forsvinder normalt i løbet af 1-2 dage uden behandling.
English: 4.9 Overdose No case of overdose has been reported.
Danish: 4.9 Overdosering Der er ikke rapporteret tilfælde af overdosering.
English: Date and time of mixing:
Danish: Dato og tidspunkt for sammenblanding:
English: 08 July 2010 (pending on enrolment of subjects and data availability)
Danish: 8. juli 2010 (afhængig af inklusionen af personer og tilgængelige data)
English: The immune response to Fluarix was satisfactory.
Danish: Immunresponset mod Fluarix var tilfredsstillende.
English: Tell your doctor if you are pregnant, think you may be pregnant, plan to become pregnant.
Danish: Fortæl det til din læge, hvis du er gravid, tror du kan være gravid eller planlægger at blive gravid.
English: And also from:
Danish: Samt yderligere fra:
English: The dose recommendations take into account available data from:
Danish: De anbefalede doser tager hensyn til tilgængelige data fra:
English: Interim and final results will be submitted one week after being available.
Danish: Interim og endelige resultater vil blive indsendt en uge efter opnåelsen af disse.
English: Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly around the world.
Danish: Pandemisk influenza er en type influenza, som forekommer med nogle årtiers mellemrum, og som spreder sig hurtigt i hele verden.
English: This vaccine complies with the WHO recommendation and EU decision for the pandemic.
Danish: Denne vaccine opfylder WHO's anbefalinger og EU's beslutninger i forbindelse med en pandemi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/624/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/10/624/001
English: Study initiated in October 2009; Final report foreseen in April 2010
Danish: Forsøg initieret i oktober 2009; Endelig rapport forventes i april 2010
English: • if you have a severe infection with a high temperature (over 38°C).
Danish: • hvis du har en alvorlig infektion med høj feber (over 38 °C).
English: The frequency of adverse reactions was similar between the two groups.
Danish: Hyppigheden af bivirkningerne var sammenlignelige for begge grupper.
English: Details regarding databases (e.g., data sources, characteristics of the data, potential analysis) need to be
Danish: Detaljer om databaserne (f.eks. datakilder, karakteristik af data, potentiel analyse) skal rapporteres.
English: Interpandemic trivalent vaccines
Danish: Interpandemiske trivalente vacciner
English: Pandemic influenza vaccine should be used in accordance with Official Guidance.
Danish: Pandemisk influenza-vaccine bør anvendes i overensstemmelse med officielle retningslinjer.
English: None of the ingredients in the vaccine can cause flu.
Danish: Ingen af indholdsstofferne i vaccinen kan forårsage influenza.
English: When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease.
Danish: Når en person vaccineres, danner immunsystemet (kroppens naturlige forsvarsmekanisme) sin egen beskyttelse (antistoffer) mod sygdommen.
English: • The correct way to prepare the vaccine prior to administration.
Danish: • Instruktion i korrekt tilberedning af vaccinen forud for administration.
English: Read all of this leaflet carefully before you receive this vaccine.
Danish: Læs denne indlægsseddel grundigt inden du får denne vaccine.
English: In these clinical studies most side effects were mild in nature and short term.
Danish: De fleste bivirkninger i disse forsøg var milde og kortvarige.
English: >80 years
Danish: > 80 år
English: Arepanrix has been authorised under “Conditional Approval”.
Danish: Arepanrix er blevet godkendt med en ”betinget godkendelse”.
English: The use of a second dose should take into consideration the information provided in sections 4.4, 4.8 and 5.1.
Danish: Ved administration af anden vaccinedosis skal der tages højde for informationerne anført i afsnit 4.4, 4.8 og 5.1.
English: If this applies to you then your vaccination will usually be postponed until you are feeling better.
Danish: Hvis dette gælder for dig, vil vaccinationen blive udsat, indtil du har det bedre.
English: Your doctor or nurse will administer the vaccine in accordance with official recommendations.
Danish: Din læge eller sygeplejerske vil give dig vaccinen i overensstemmelse med officielle anbefalinger.
English: PSUR submission during the influenza pandemic:
Danish: Indsendelse af PSUR under en influenza-pandemi:
English: • Severe stabbing or throbbing pain along one or more nerves
Danish: • Kraftigt stikkende eller bankende smerter langs en eller flere nerver
English: Timelines described in the RMP
Danish: Indsendelses tidspunkt beskrevet i RMP.
English: The vaccine will be injected into a muscle (usually in the upper arm).
Danish: Vaccinen vil blive indsprøjtet i en muskel (normalt i overarmen).
English: Retrospective cohort: to be initiated in Feb 2010; Preliminary analysis in April
Danish: Retrospektiv kohorte: vil blive initieret i februar 2010; præliminære analyser i april.
English: Do not use the suspension and the emulsion after the expiry date which is stated on the carton.
Danish: Brug ikke suspensionen og emulsionen efter den udløbsdato, der står på pakningen.
English: 71-80 years
Danish: 71-80 år
English: Prompt analysis of cumulative safety information, in light of the extent of exposure, will be crucial for regulatory decisions and protection of the population to be vaccinated.
Danish: Omgående analyse af de kumulative sikkerhedsoplysninger er i lyset af omfanget af eksponering afgørende for myndighedernes beslutning og beskyttelse af den population, der skal vaccineres.
English: The vaccine contains an ‘adjuvant' AS03 to stimulate a better response.
Danish: Vaccinen indeholder en 'adjuvans' (AS03) for at opnå en bedre virkning.
English: Results submitted 1 week after being available.
Danish: Resultaterne indsendt en uge efter opnåelsen af disse.
English: Instructions for mixing and administration of the vaccine:
Danish: Instruktion for rekonstitution og administration af vaccinen:
English: After the addition of the adjuvant to the antigen, the mixture should be well shaken.
Danish: Efter tilsætning af adjuvans til antigen, skal blandingen omrystes godt.
English: You should discuss with your doctor whether you should receive Arepanrix.
Danish: Du skal drøfte med din læge, om du bør få Arepanrix.
English: These transitory false-positive results may be due to IgM production in response to the vaccine.
Danish: De forbigående falsk positive resultater kan skyldes vaccineinduceret produktion af IgM.
English: Arepanrix can only be marketed when there is an official WHO/EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Arepanrix takes due account of the officially declared pandemic strain.
Danish: Arepanrix kan kun markedsføres, hvis der findes en officiel WHO/EU-erklæring om en pandemisk influenza og kun på betingelse af at markedsføringstilladelsesindehaveren af Arepanrix tager passende hensyn til den officielt erklærede pandemiske vaccinestamme.
English: • The minimal data elements to be transmitted in individual case safety reports in order to facilitate the evaluation and the identification of the vaccine administered to each subject, including the invented name, the vaccine manufacturer and the batch number.
Danish: • At minimumskriterier for data overført til ”individual case safety reports” giver mulighed for at evaluere og identificere den administrerede vaccine inklusive produktnavn, fremstiller og batchnummer.
English: If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile illness or acute infection.
Danish: Hvis den pandemiske situation tillader det, skal vaccination af patienter med svær, febril sygdom eller akut infektion udsættes.
English: Area
Danish: Område
English: Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB02.
Danish: Farmakoterapeutisk klassifikation: Influenza-vacciner, ATC-kode J07BB02.
English: Excipients: the vaccine contains 5 micrograms thiomersal
Danish: Hjælpestoffer: vaccinen indeholder 5 mikrogram thiomersal.
English: The symptoms of pandemic flu are similar to those of ordinary flu but may be more severe.
Danish: Symptomerne (tegnene) på en pandemisk influenza er de samme som ved en almindelig influenza, men de kan være mere alvorlige.
English: • if you are having a blood test to look for evidence of infection with certain viruses.
Danish: • hvis du skal have taget en blodprøve for at fastslå en eventuel infektion forårsaget af bestemte vira.
English: During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation (EC) No 726/2004 will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time.
Danish: Under en pandemi er frekvensen for indsendelse af PSUR som nævnt i artikel 24 i EU's forordning nr. 726/2004 ikke tilstrækkelig i forbindelse med sikkerhedsmonitorering af en pandemisk vaccine, hvor patienterne forventes at blive udsat for høj eksponering i løbet af kort tid.
English: The characteristics and the validity of these sources is to be agreed with EMEA within 1 month of the Commission Decision granting the Marketing Authorisation in order to conduct additional studies for emerging benefitrisk evaluation.
Danish: Karakteristikken og valideringen af disse kilder skal aftales med EMEA inden for 1 måned efter Kommissiones godkendelse af markedsføringstilladelsen for, at kunne understøtte yderligere udvikling i evalueringen af risikobalancen.
English: From Post-marketing surveillance with interpandemic trivalent vaccines, the following adverse reactions have also been reported:
Danish: I forbindelse med overvågning efter markedsføring af interpandemiske, trivalente vacciner er der også indberettet følgende bivirkninger:
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Danish: Som ved alle andre injicerbare vacciner, skal passende medicinsk behandling og overvågning altid være til stede i tilfælde af, at der opstår en sjælden, anafylaktisk reaktion efter administration af vaccinen.
English: • Post-marketing surveillance
Danish: • Overvågning efter markedsføring
English: The vaccine should not be administered intravascularly.
Danish: Vaccinen bør ikke administreres intravaskulært.
English: 3-5 years
Danish: 3-5 år
English: • Other ingredients:
Danish: • Øvrige indholdsstoffer:
English: OTHER Storage (2ºC-8ºC), do not freeze, protect from light
Danish: ANDET Opbevaring (2 °C til 8 °C), må ikke fryses, beskyttes mod lys
English: In such cases, the Western blot method is negative.
Danish: I disse tilfælde vil den efterfølgende Western Blot-analyse give negative resultater.
English: Animal studies with Arepanrix do not indicate reproductive toxicity (see section 5.3).
Danish: Dyreforsøg med Arepanrix indikerer ikke reproduktiv toksicitet (se pkt.
English: Tell the doctor requesting these tests that you have recently been given Arepanrix.
Danish: Fortæl det til den læge, som har udbedt sig disse blodprøver, at du for nyligt har fået Arepanrix.
English: As with all vaccines, Arepanrix may not fully protect all persons who are vaccinated.
Danish: Som det også er tilfældet for andre vacciner, giver Arepanrix ikke fuld beskyttelse til alle, der bliver vaccineret.
English: This medicinal product contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose, i.e. essentially sodium- and potassium-free.
Danish: Denne medicin indeholder mindre end 1 mmol natrium (23 mg) og mindre end 1 mmol kalium (39 mg) pr. dosis, dvs. det er stort set natrium- og kaliumfrit.
English: This means that further evidence on this medicinal product is awaited.
Danish: Det betyder, at der stadig afventes yderligere evidens for lægemidlet.
English: The clinical relevance of the haemagglutination inhibition (HI) titre ≥1:40 in children is unknown.
Danish: Den kliniske relevans af hæmagglutinationshæmmingstiter (HI) ≥ 1:40 hos børn er ukendt.
English: 4all subjects seronegative prior to vaccination
Danish: alle seronegative personer før vaccination
English: The Applicant/MAH commits not to release lots prepared using the extended formulation/fill process until the relevant validation data have been submitted and approved (RR#7Q5)
Danish: Kvalitative aspekter Ansøgeren/indehaveren af markedsføringstilladelsen forpligter sig til ikke at frigive batch fremstillet ved brug af den udvidede fremstillings-/fylde-proces, indtil relevante valideringsdata er indsendt og godkendt (RR#7Q5).
English: Important information about some of the ingredients of Arepanrix This vaccine contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Arepanrix Denne vaccine indeholder thiomersal som konserveringsmiddel, og det er muligt, at du kan få en overfølsomhedsreaktion.
English: • Adverse events to be prioritised for reporting, i.e. fatal and life-threatening adverse reactions, unexpected severe adverse reactions, adverse events of special interest (AESI).
Danish: • At visse bivirkninger i forbindelse med indberetning skal opprioriteres, dvs. fatale og livstruende bivirkninger, uventede alvorlige bivirkninger, bivirkninger af speciel interese (AESI).
English: A dose (0.25 ml) of the vaccine will be given.
Danish: En dosis (0,25 ml) vaccine vil blive givet.
English: Some effects mentioned under section 4.
Danish: Nogle af de bivirkninger, der er nævnt i pkt.
English: • The Applicant/MAH shall agree with Member States to measures facilitating the identification and traceability of the A/H1N1 pandemic vaccine administered to each patient, in order to minimise medication errors and aid patients and health care professionals to report adverse reactions.
Danish: • Ansøgeren/Indehaveren af markedsføringstilladelsen skal sammen med medlemslandene aftale foranstaltninger, der muliggør identifikation og sporbarhed af den A/H1N1 pandemiske vaccine, som administreres til hver enkelt patient, for herved at minimere administrationsfejl og hjælpe patienter og sundhedspersonale med at indberette bivirkninger.
English: Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.
Danish: Sundhedspersonalet skal derfor overveje fordele og potentielle risici ved administration af vaccinen til personer med trombocytopeni eller andre koagulationsforstyrrelser, hvor intramuskulær injektion er kontraindiceret, medmindre den potentielle fordel er større end risikoen for blødning.
English: The side-effects are generally similar to those related to seasonal flu vaccines.
Danish: Bivirkningerne er generelt de samme som ved sæsoninfluenza.
English: The side effects listed below have occurred in the days or weeks after vaccination with vaccines given routinely every year to prevent flu.
Danish: Bivirkningerne nedenfor er set i dagene eller ugerne efter vaccination med den vaccine, som gives rutinemæssigt til beskyttelse af sæsoninfluenza.
English: Pharmacovigilance The Applicant/MAH commits to support a Postauthorisation study in immunocompromised subjects (adults with HIV) being conducted by PCIRN (Public Health Agency of Canada - Canadian Institutes of Health Research Influenza Research Network) and provide the final result
Danish: Pharmacovigilance Ansøgeren/indehaveren af markedsføringstilladelsen forpligter sig til at understøtte et post-marketing forsøg i immunkompromitterede personer (voksne med hiv) som udføres af PCIRN (Public Health Agency of Canada - Canadian Institutes of Health Research Influenza Research Network) og at indsende det endelige resultat.
English: Immune response to Arepanrix (H1N1) in adults aged 18-60 years:
Danish: Immunrespons mod Arepanrix (H1N1) hos voksne i alderen 18-60 år:
English: If vaccination is considered to be necessary, facilities for resuscitation should be immediately available in case of need.
Danish: Hvis vaccination skønnes nødvendig, skal genoplivningsudstyr være umiddelbart inden for rækkevidde, hvis behovet skulle opstå.
English: The results of this heterologous challenge study indicate 80.7%-100% protection in all adjuvanted candidate vaccines compared to 43% protection with the non adjuvanted vaccine, showing the benefit of AS03 adjuvantation.
Danish: Resultatet af dette heterologe forsøg indikerer en beskyttelse på 80,7 % - 100 % for alle adjuverede vaccinekandidater sammenlignet med 43 % beskyttelse for ikke-adjuverede vacciner, hvilket viser fordelen ved AS03 adjuveringen.
English: A minor infection such as a cold should not be a problem, but your doctor will advise whether you could still be vaccinated with Arepanrix.
Danish: En mindre infektion, f.eks. forkølelse, er normalt ikke noget problem, men lægen eller sygeplejersken afgør, om du kan vaccineres med Arepanrix.