FrancophonIA/ELRC3.0 huggingface dataset:
English: In the absence of compatibility studies, this medicinal product must not be mixed with other
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med
English: The data below summarizes the frequencies of the adverse reactions that were recorded following vaccination during clinical trials and worldwide post-marketing experience, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000), not known (cannot be estimated from available data).
Danish: Nedenstående data fra kliniske studier opsummerer hyppigheden af de bivirkninger, som blev indberettet efter vaccination i kliniske studier og erfaringer efter markedsføring globalt med anvendelse af følgende termer: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000) meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: This vaccine is recommended to help to protect you against flu.
Danish: Denne vaccine er beregnet til at give beskyttelse imod influenza.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemidler samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: INTANZA will help to protect you against the three strains of virus contained in the vaccine, or other strains closely related to them.
Danish: INTANZA vil hjælpe med at give beskyttelse imod de tre virusstammer, som vaccinen indeholder, eller andre stammer, der er nært beslægtet med disse.
English: INTANZA may be given at the same time as other vaccines.
Danish: INTANZA kan gives samtidig med andre vacciner.
English: INTANZA is not recommended for use in children and adolescents below 18 years due to insufficient data on safety and efficacy.
Danish: INTANZA anbefales ikke til børn og unge under 18 år på grund af utilstrækkelige data vedr.
English: During clinical trials and after the vaccine came on the market, the following side effects were reported with the use of INTANZA.
Danish: Under de kliniske undersøgelser og efter markedsføring af vaccinen har følgende bivirkninger været indberettet i forbindelse med brugen af INTANZA:
English: Please read the instruction before use
Danish: Læs brugsanvisningen inden brug
English: What you need to know before you use INTANZA
Danish: Det skal De vide, før De begynder at tage INTANZA
English: The most common reactions occurring after vaccine administration were local reactions at injection
Danish: De almindeligste reaktioner, som forekom efter vaccination, var lokale reaktioner på
English: INTANZA is administered to you by your doctor or nurse.
Danish: De vil få INTANZA af Deres læge eller sygeplejerske.
English: You hear a click and a shield comes out to cover the needle.
Danish: Der høres et klik, og en afskærmning kommer frem, som dækker over nålen.
English: INTANZA should under no circumstances be administered intravascularly.
Danish: INTANZA må under ingen omstændigheder gives intravaskulært.
English: Full effect of the vaccine is generally achieved 2-3 weeks after the
Danish: Fuld effekt af vaccinen opnås normalt 2 til 3
English: Other vaccines or medicines and INTANZA Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Danish: Brug af andre vacciner eller anden medicin sammen med INTANZA Fortæl altid til lægen eller apotekspersonalet, hvis De bruger anden medicin eller har gjort det for nylig.
English: Sanofi Pasteur - Parc Industriel d'Incarville - 27100 Val-de-Reuil - France Sanofi Pasteur, Campus Mérieux - 1541, avenue Marcel Mérieux - 69280 Marcy l'Etoile - France For any information about this medicine, please contact the local representative of the Marketing
Danish: Sanofi Pasteur - Parc Industriel d'Incarville- 27100 Val-de-Reuil- Frankrig Sanofi Pasteur, Campus Mérieux - 1541, avenue Marcel Mérieux - 69280 Marcy l'Etoile - Frankrig Hvis De ønsker yderligere oplysninger om dette lægemiddel, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: The safety of INTANZA has been assessed in 3 open-label randomised clinical trials, 3,372 vaccinees received an injection of INTANZA.
Danish: INTANZAs sikkerhed er blevet undersøgt i 3 randomiserede, åbne kliniske undersøgelser, i hvilke 3.372 personer blev vaccineret med INTANZA.
English: - Other vaccines: INTANZA can be given at the same time as other vaccines by using separate limbs.
Danish: - Andre vacciner: INTANZA kan gives samtidig med andre vacciner, hvis der bruges separate ekstremiteter.
English: - You should tell your doctor before vaccination if you have a poor immune response (immunosuppression) due to disease or medicines, because the vaccine may not work very well in this case.
Danish: - De skal fortælle det til Deres læge, hvis Deres immunforsvar er svækket (immunsuppression) uanset om det skyldes sygdom eller medicin, da dette kan betyde, at vaccinen i så fald ikke fungerer så godt.
English: INTANZA has no or negligible influence on the ability to drive and use machines.
Danish: INTANZA påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: When an injection of INTANZA is given, the immune system (body's natural defences) will develop
Danish: Når man får en vaccination med INTANZA, vil immunsystemet (kroppens naturlige forsvarssystem) udvikle beskyttelse imod influenzasmitte.
English: Store in a refrigerator (2°C-8°C).
Danish: Opbevares i køleskab (2 C - 8 C).
English: Very limited data in immunocompromised patients are available for INTANZA.
Danish: Der foreligger kun meget begrænsede data vedrørende INTANZA hos immunkompromitterede
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine (see
Danish: Som ved alle injicerbare vacciner, bør passende medicinsk behandling og overvågning altid være til rådighed i tilfælde af, at der skulle opstå en anafylaktisk reaktion efter administration af vaccinen (se
English: EU/1/08/505/004 - pack of 1 pre-filled syringe with a Micro-Injection System EU/1/08/505/005 - pack of 10 pre-filled syringes with a Micro-Injection System EU/1/08/505/006 - pack of 20 pre-filled syringes with a Micro-Injection System
Danish: EU/1/08/505/004 - pakning med 1 fyldt injektionssprøjte med et mikroinjektionssystem EU/1/08/505/005 - pakning med 10 fyldte injektionssprøjter med et mikroinjektionssystem EU/1/08/505/006 - pakning med 20 fyldte injektionssprøjter med et mikroinjektionssystem
English: Reactions of not known frequency (frequency cannot be estimated from the available data) - Allergic reactions including skin reactions that may spread throughout the body such as hives, severe allergic reactions (anaphylactic reactions), swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breathe (angioedema), failure of the circulatory system
Danish: Reaktioner med ikke kendt hyppighed (hyppighed kan ikke vurderes ud fra tilgængelige data) - Allergiske reaktioner, herunder hudreaktioner, som kan brede sig til hele kroppen, som f.eks. nældefeber, alvorlige allergiske reaktioner (anafylaktiske reaktioner), hævelse af ansigt, tunge eller i svælget, synkebesvær, nældefeber og vejrtrækningsbesvær (angioødem), kredsløbssvigt
English: INTANZA may contain residues of eggs such as ovalbumin and residues of neomycin, formaldehyde and octoxinol 9, which are used during the manufacturing process (see section 4.3).
Danish: INTANZA kan indeholde reststoffer fra æg som f.eks. ovalbumin og rester af neomycin, formaldehyd og octoxinol 9, som anvendes under fremstillingen (se pkt.
English: The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually
Danish: Varigheden af immuniteten imod homologe stammer eller stammer, som er nært relateret til vaccinestammerne, varierer, men er normalt 6-12
English: Pack of 1 or 10 or 20 pre-filled syringe(s) with a Micro-Injection System
Danish: Pakning med 1 eller 10 eller 20 fyldte injektionssprøjte(r) med mikroinjektionssystem
English: INTANZA is given as an injection into the upper layer of the skin (preferably the muscle of the upper
Danish: INTANZA gives som en injektion i det øverste hudlag (fortrinsvis i området over overarmsmusklen).
English: Sanofi Pasteur Europe, 2 Avenue Pont Pasteur, 69007 Lyon, France.
Danish: Sanofi Pasteur Europe, 2 Avenue Pont Pasteur, 69007 Lyon, Frankrig.
English: Apparent local reactions after intradermal administration were more frequent than after intramuscular administration of an adjuvanted or non-adjuvanted comparator vaccine.
Danish: Forekomsten af lokale reaktioner efter intrakutan indgivelse var hyppigere end efter intramuskulær indgivelse af en vaccine med eller uden adjuvans, der blev anvendt til sammenligning.
English: Remove the needle cap from the Micro-Injection
Danish: Tag nålehætten af mikroinjektions
English: Marketing Authorisation Holder: Sanofi Pasteur Europe, 2 Avenue Pont Pasteur, 69007 Lyon,
Danish: Indehaver af markedsføringstilladelsen: Sanofi Pasteur Europe, 2 Avenue Pont Pasteur, 69007 Lyon,
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Danish: Hvis De oplever bivirkninger, bør De tale med din læge, sygeplejerske eller apoteket.
English: HOW TO USE INTANZA
Danish: SÅDAN FÅR DE INTANZA
English: Injection is considered successful whether or not the presence of a
Danish: Injektionen betragtes som vellykket uanset om der observeres tilstedeværelse af et prik i huden eller ej.
English: A/Michigan/45/2015 (H1N1)pdm09 - like strain A/Hong Kong/4801/2014 (H3N2) - like strain
Danish: A/Michigan/45/2015 (H1N1)pdm09 - lignende stamme A/Hong Kong/4801/2014 (H3N2) - lignende stamme
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest ændret i MM/ÅÅÅÅ
English: What INTANZA contains
Danish: Intanza indeholder:
English: INTANZA is at least as immunogenic as the comparator trivalent inactivated influenza vaccine administered by intramuscular route for each of the 3 influenza strains in subjects from 60 years of age and over.
Danish: INTANZA er mindst lige så immunogent som den trivalente, inaktiverede influenzavacine givet via intramuskulær injektion for hver af de 3 influenzastammer hos forsøgspersoner i alderen fra 60 år og
English: INTANZA is as immunogenic as the comparator trivalent adjuvanted (MF-59 containing) vaccine in terms of GMT for each of the 3 influenza strains with the SRH method and for 2 strains with the HI method.
Danish: INTANZA er lige så immunogent som den trivalente, inaktiverede influenzavacine med adjuvans (MF-59), som blev brugt til sammenligning, med hensyn til GMT for hver af de 3 influenzastammer, baseret på SRH-metoden, og for 2 stammer, baseret på HI-metoden.
English: Systemic safety profile of INTANZA is similar to the comparator vaccine, adjuvanted or nonadjuvanted, administered intramuscularly.
Danish: INTANZAs systemiske sikkerhedsprofil svarer til den, som blev observeret ved intramuskulær indgivelse af en vaccine med eller uden adjuvans, der blev anvendt til sammenligning.
English: In a pivotal randomised comparative phase III trial, 2,606 subjects over 60 years of age received 0.1 ml of INTANZA by intradermal route and 1,089 subjects over 60 years of age received 0.5 ml of a trivalent inactivated influenza vaccine administered by intramuscular route.
Danish: I en pivotal randomiseret komparativ fase III-undersøgelse fik 2.606 forsøgspersoner på over 60 år 0,1 ml INTANZA administreret intrakutant, og 1.089 forsøgspersoner på over 60 år fik 0,5 ml trivalent inaktiveret influenzavaccine administreret intramuskulær.
English: In a randomised comparative phase III trial, 398 subjects over 65 years of age received 0.1 ml of INTANZA by intradermal route and 397 subjects over 65 years of age received 0.5 ml of a trivalent inactivated adjuvanted (MF-59 containing) influenza vaccine at the same dosage administered by intramuscular route.
Danish: I en randomiseret komparativ fase III undersøgelse fik 398 personer over 65 år 0,1 ml INTANZA administreret intrakutant, og 397 personer over 65 år fik 0,5 ml trivalent inaktiveret influenzavaccine (med samme dosis) med adjuvans (MF-59) administreret intramuskulært.
English: In case of presence of liquid at the injection site after vaccine administration, re-vaccination is not required.
Danish: Selv om der skulle forekomme væske på injektionsstedet efter vaccination, er genvaccination ikke påkrævet.
English: The active substances are Influenza virus (inactivated split) of the following strains*:
Danish: De aktive indholdsstoffer er influenzavirus (inaktiveret, split) fra følgende stammer*:
English: Talk to your doctor, pharmacist or nurse before using INTANZA.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før De tager INTANZA.
English: After repetitive yearly injections the safety profile of INTANZA is similar to the previous injections.
Danish: Efter gentagne årlige injektioner svarer INTANZAs sikkerhedsprofil til den, der sås ved de tidligere b. Oversigt over bivirkninger i tabelform
English: Influenza virus (inactivated, split) of the following strains*:
Danish: Influenzavirus (inaktiveret, split) fra følgende stammer*:
English: With the same hand, push very firmly with the thumb on the plunger to activate the needle shield.
Danish: Brug den samme hånd som ved injektionen, og tryk meget kraftigt med tommelfingeren på stemplet for at aktivere nåleafskærmningen.
English: divize vakcín sanofi-aventis, s.r.o.
Danish: Česká republika Sanofi Pasteur divize vakcín sanofi-aventis, s.r.o.
English: Influenza virus (inactivated, split) of the following strains:
Danish: Influenzavirus (inaktiveret, split) fra følgende stammer:
English: INTANZA 15 microgram/strain, suspension for injection Influenza vaccine (split virion, inactivated)
Danish: INTANZA 15 mikrogram/stamme injektionsvæske, suspension Influenzavaccine (split virion, inaktiveret)
English: A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Michigan/45/2015, NYMC X-275) ................................................................................................................................ 15 micrograms HA** A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B) ................................................................................................................................ 15 micrograms HA** B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) ....................... 15 micrograms HA**
Danish: A/Hong Kong/4801/2014 (H3N2) - lignende stamme (A/Hong Kong/4801/2014, NYMC X-263B) ……..…........................................................................................................... ....... ..15 mikrogram HA** B/Brisbane/60/2008 - lignende stamme (B/Brisbane/60/2008, vild type) ............... 15 mikrogram HA**
English: INTANZA is a suspension for injection in a pre-filled syringe of 0.1 ml with a Micro-Injection
Danish: INTANZA er en injektionsvæske, suspension i en fyldt injektionssprøjte på 0,1 ml med mikroinjektionssystem i pakninger med 1, 10 eller 20.
English: See also section 3.
Danish: Se også pkt.
English: Pre-filled syringe label text
Danish: Tekst på etiket på fyldt injektionssprøjte
English: A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Michigan/45/2015, NYMC X-275) ............................................................................................................................. 15 micrograms HA**
Danish: A/Michigan/45/2015 (H1N1)pdm09 - lignende stamme (A/Michigan/45/2015, NYMC X-275) ................. ................................................................................................................. 15 mikrogram HA**
English: • Any component that may be present in very small amounts such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol 9.
Danish: • alle indholdsstoffer, som kan findes i vaccinen i meget små mængder, fx æg (ovalbumin,
English: Sanofi-Aventis Estonia OÜ Tel.: +372 627 3488
Danish: Sanofi Aventis Latvia SIA Vakcīnu nodaļa Tel.: +371 67114978
English: Detailed information on this vaccine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Se den nyeste indlægsseddel på www.indlaegsseddel.dk.
English: B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) .................... 15 micrograms HA**
Danish: B A/New Caledonia/ 20/99 A/Wisconsin/ 67/2005 B/Malaysia/ 2506/2004
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26 June 2017
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26.
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/118)
Danish: Resultatet af en indbringelsesprocedure i henhold til artikel 35 i direktiv 2001/82/EF (EMEA/V/A/118)
English: What is zinc oxide?
Danish: Hvad er zinkoxid?
English: The European Commission issued a decision on 26 June 2017 and Member States may defer the withdrawal of the marketing authorisations for up to five years from this date, if they consider that immediate action may have adverse impact in their territory given the lack of availability of alternatives and the change required in pig farming practices.
Danish: Europa-Kommissionen udstedte en afgørelse 26. juni 2017, og medlemsstaterne kan udsætte tilbagetrækningen af markedsføringstilladelserne i op til fem år fra denne dato, hvis de mener, at omgående handling vil have en negativ indvirkning på deres territorium i betragtning af manglen på alternativer og den krævede ændring i svineavlspraksisser.
English: Zinc oxide is an inorganic compound and is known to be relatively poorly absorbed.
Danish: Zinkoxid er en uorganisk forbindelse kendt for at blive absorberet forholdsvis dårligt.
English: Different indications and dosages are currently recommended, but zinc oxide is mainly used in the feed at a dosage of 100 mg per kg body weight per day for 14 consecutive days, which equates to 2500 ppm zinc in feed.
Danish: Aktuelt anbefales forskellige indikationer og doseringer, men zinkoxid anvendes primært i foder i daglige doser på 100 mg pr. kg legemsvægt i 14 dage i træk, svarende til 2 500 ppm zink i foder.
English: The applicants and marketing authorisation holders concerned by the referral procedure submitted proprietary data and scientific references on efficacy, antimicrobial resistance and environmental risk.
Danish: Ansøgere om markedsføringstilladelse samt indehavere heraf, der er berørte af proceduren for indbringelse af sager, indgav oplysninger om eneret og videnskabelige referencer om effektivitet, antimikrobiel resistens og miljørisiko.
English: Why were orally-administered veterinary medicinal products containing zinc oxide reviewed?
Danish: Hvorfor blev veterinærlægemidler, der indeholder zinkoxid, gennemgået?
English: On 16 March 2017, the European Medicines Agency (the Agency) completed a review of the safety and effectiveness of veterinary medicinal products containing zinc oxide to be administered orally to food-producing species.
Danish: Den 16. marts 2017 afsluttede Det Europæiske Lægemiddelagentur (agenturet) en gennemgang af sikkerheden og virkningen af lægemidler, der indeholder zinkoxid og skal gives oralt til - fødevareproducerende arter.
English: The CVMP acknowledged that there is a risk of co-selection for resistance (the selection of multiple antimicrobial resistance genes by an antimicrobial) associated with the use of zinc oxide but that, at the present time, such risk is not quantifiable.
Danish: CVMP anerkender, at der er en risiko for co-selektion for resistensgener (selektion af adskillige antimikrobielle resistensgener ved et antimikrobielt stof) forbundet med anvendelsen af zinkoxid, men at risikoen ikke kan kvantificeres på nuværende tidspunkt.
English: The CVMP recommended the refusal of the granting of the marketing authorisations and the withdrawal of the existing marketing authorisations for veterinary medicinal products containing zinc oxide.
Danish: CVMP har anbefalet afslag på udstedelse af markedsføringstilladelse og tilbagetrækning af de eksisterende markedsføringstilladelser for veterinærlægemidler, der indeholder zinkoxid.
English: The CVMP considered that there is some uncertainty associated with the calculated risks for some environmental compartments and recommended various risk mitigation measures, which were anticipated to reduce the accumulation of zinc in the environment.
Danish: CVMP mente, at der er en vis usikkerhed forbundet med risikoberegningen i forbindelse med visse omgivende miljøer og anbefalede forskellige foranstaltninger til afbødning af risici, der forventedes af reducere ophobningen af zink i miljøet.
English: Nevertheless, in February 2016, due to remaining concerns related to the risk to the environment and the potential increase of prevalence of antibiotic resistant bacteria from the use of products containing zinc oxide, the Netherlands and France initiated a referral procedure under Article 35 of Directive 2001/82/EC for all orally-administered veterinary medicinal products containing zinc oxide and requested the CVMP to review all available data and to evaluate the overall benefit-risk balance of the products concerned.
Danish: På grund af resterende bekymringer om risikoen for miljøet og den eventuelle øgning i prævalensen af antibiotikaresistente bakterier fra brugen af midler, der indeholder zinkoxid, iværksatte Nederlandene og Frankrig, alligevel i februar 2016, en procedure for indbringelse af sager i henhold til artikel 35 i direktiv 2001/82/EF for alle veterinærlægemidler, der indeholder zinkoxid og gives oralt, og anmodede CVMP om at gennemgå alle tilgængelige data samt vurdere det overordnede benefit/risk-forhold for de pågældende produkter.
English: In May 2015, following a referral procedure (EMEA/V/A/108) under Article 33(4) of Directive 2001/82/EC for Gutal 1000 g/kg premix for medicated feeding stuff for piglets1, the CVMP identified a risk to the environment due to accumulation of zinc.
Danish: Som følge af en procedure for indbringelse af sager (EMEA/V/A/108) i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF for Gutal 1 000 g/kg-forblanding til medicineret foder til smågrise1, identificerede CVMP, i maj 2015, en risiko for miljøet pga. ophobning af zink.
English: Effective measures to manage the accumulation of zinc in the environment were not identified and, as a result, the CVMP recommended the refusal of the granting of the marketing authorisations and the withdrawal of the existing marketing authorisations for veterinary medicinal products containing zinc oxide.
Danish: Der blev ikke fastlagt effektive foranstaltninger til håndtering af ophobningen af zink i miljøet, og som resultat heraf anbefalede CVMP at afvise udstedelse af markedsføringstilladelser samt at trække eksisterende markedsføringstilladelser for veterinære lægemidler med zinkoxid, tilbage.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for veterinary medicinal products containing zinc oxide to be administered orally to pigs is negative, as the benefits of zinc oxide for the prevention of diarrhoea in pigs do not outweigh the risks for the environment.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at den overordnede benefit/risk-balance for veterinærlægemidler, der indeholder zinkoxid og administreres oralt til grise, er negativ, da fordelene ved zinkoxid til forebyggelse af diarré hos grise ikke opvejer risikoen for miljøet.