FrancophonIA/ELRC3.0 huggingface dataset:
English: (~8.8µg/kg) 1 (~17.6µg/kg) 1 (~27.2µg/kg) 1 (~36µg/kg) 1 (~44.8µg/kg) 1 ml ml ml ml ml
Danish: (~ 8,8 µg/kg)1
English: • skeletal muscle relaxants (botulinum toxin)
Danish: • muskelafslappende midler (botulismetoksin)
English: − has myasthenia gravis (muscle weakness and tiredness)
Danish: − har svækkede muskler ledsaget af træthed (myasthenia gravis)
English: Salivation is primarily mediated by parasympathetic innervation of the salivary glands.
Danish: Spytsekretion medieres fortrinsvist af parasympatisk innervering af spytkirtlerne.
English: • Abnormal contractions of the digestive tract when food is ingested (gastrointestinal motility disorder)
Danish: • Unormale sammentrækninger i fordøjelseskanalen ved indtagelse af mad
English: The significance of the non-clinical findings for humans is not clear, and the lack of human data on the medicinal product leads to glycopyrronium being contraindicated in pregnant women.There are insufficient data in the public domain to adequately assess effects on the reproductive system in young adults, and safety in human pregnancy has not been established.
Danish: Betydningen af disse prækliniske fund for mennesker er ikke klarlagt, og manglen på humane data for glycopyrronium gør, at lægemidlet er kontraindiceret til gravide kvinder.
English: Frequency category
Danish: Periodisk letantændelighed
English: glycopyrronium has low central bioavailability, except in the case where the blood brain barrier has been compromised (e.g. a shunt infection).
Danish: Hos den pædiatriske population var biotilgængeligheden af glycopyrronium i CNS lav efter administration af 5 mikrogram/kg glycopyrronium intravenøst, medmindre blod-hjerne-barrieren er kompromitteret (f.eks. ved shuntinfektion).
English: Monitoring by physicians and caregivers is required with adherence to the management instructions below:
Danish: Lægen og omsorgspersonen skal overvåge sådanne bivirkninger og følge nedenstående vejledning til at håndtere dem:
English: • Reduced secretions in the chest;
Danish: • Nedsat sekret i bronkierne
English: Oral solution One 60 ml bottle One 8 ml oral syringe One syringe adaptor.
Danish: Oral opløsning En 60 ml flaske En 8 ml oral sprøjte En sprøjteadapter.
English: General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administrationsstedet Pyreksi
English: After use, leave the syringe adaptor in the neck of the bottle.
Danish: Lad sprøjteadapteren blive siddende i flaskehalsen efter brug.
English: • allergic reaction (rash, itching, red raised itchy rash (hives), difficulty breathing or swallowing, dizziness)
Danish: • Allergisk reaktion (udslæt, kløe, nældefeber, besvær med at trække vejret eller synke,
English: Caution should be exercised in children with compromised blood brain barrier eg.
Danish: Der skal udvises forsigtighed hos børn med kompromitteret blod-hjerne-barriere f.eks. på grund af intraventrikulær shunt, hjernetumor eller encefalitis.
English: Dental
Danish: Tænder
English: Glycopyrronium should be discontinued if pneumonia is present.
Danish: Behandlingen med glycopyrronium bør afbrydes, hvis patienten får pneumoni.
English: No effects on fertility were observed in male rats.
Danish: Der er ikke set påvirkning af fertiliteten hos hanrotter.
English: dose was low at approximately 3% (range 1.3-13.3%) in children aged 7-14 years undergoing intraocular surgery (n = 6) due to the medicinal product's low lipid solubility.
Danish: Glycopyrroniums gennemsnitlige absolutte orale biotilgængelighed ved sammenligning af en oral enkeltdosis på 50 mikrogram/kg og en intravenøs enkeltdosis på 5 mikrogram/kg var lav, nemlig ca. 3 % (1,3-13,3 %) hos børn i alderen 7-14 år, der gennemgik intraokulær kirurgi (n = 6), og dette skyldes lægemidlets lave fedtopløselighed.
English: If you give too much Sialanar to your child
Danish: Sådan skal du give Sialanar til barnet/den unge
English: Glycopyrronium treatment should be withdrawn until the pneumonia resolves.
Danish: Behandlingen med glycopyrronium skal afbrydes, indtil pneumonien har fortaget sig.
English: It is important to make sure an acurate dose is given each time, in order to prevent harmful effects of Sialanar seen with dosing errors or overdose.
Danish: Hvis du har givet barnet/den unge for meget Sialanar Det er vigtigt, at du hver gang sørger for at give barnet/den unge den rigtige dosis, så skadevirkninger ved forkert dosering eller overdosering af Sialanar kan undgås.
English: 3 PHARMACEUTICAL FORM
Danish: FARMAKOLOGISKE EGENSKABER
English: Dry mouth
Danish: Tør hud
English: This may affect performance at skilled tasks such as driving, riding a bicycle, or using machines.
Danish: Sialanar kan påvirke synet og koordinationsevnen og dermed evnen til at udføre opgaver, der kræver opmærksomhed, som f.eks. at køre bil, cykle og betjene maskiner.
English: Data on reproductive endpoints for glycopyrronium are very limited.
Danish: Der foreligger kun få vurderinger af reproduktionsrelaterede effektmål for glycopyrronium.
English: Long-term use
Danish: Brug over længere tid
English: Intermittent explosive disorder
Danish: Hæmmet svedafsondring
English: Drowsiness
Danish: Rastløshed
English: Mydriasis
Danish: Øjne Mydriasis
English: Overactivity
Danish: Hyperaktivitet
English: Upper respiratory tract infection
Danish: Infektioner og parasitære sygdomme Infektion i de øvre luftveje
English: Angle-closure glaucoma
Danish: Snævervinklet glaukom
English: Respiratory
Danish: Humørsvingninger
English: 1 refers to µg/kg glycopyrronium *Maximum individual dose in this weight range
Danish: * Maksimal individuel dosis i denne vægtkategori
English: Thane Road
Danish: Marine House
English: • Nasal congestion
Danish: • hæmmet svedafsondring
English: Manufacturer
Danish: Opkastning
English: Halitosis
Danish: Dosering
English: (~12.8µg/kg) 1 (~25.6µg/kg) 1 (~38.4µg/kg) 1 (~51.2µg/kg) 1 (~64µg/kg) 1 ml ml ml ml ml
Danish: (~ 36 µg/kg)1
English: This reduced transmission can de-activate the cells that produce saliva.
Danish: Ved at hæmme cellernes kommunikation kan produktionen af spyt nedsættes eller blokeres.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG
English: Hepatic impairment
Danish: Psykiske forstyrrelser Irritabilitet
English: • Upper respiratory tract infection (chest infection);
Danish: • Infektion i de øvre luftveje (f.eks. forkølelse, ondt i halsen)
English: • restlessness; overactivity; short attention span; frustration; mood changes; temper outbursts or explosive behaviour; excessive sensitivity; seriousness or sadness; frequent crying episodes;
Danish: • Rastløshed, hyperaktivitet, nedsat opmærksomhedsevne, frustration, humørsvingninger,
English: For the full list of excipients, see section 6.1
Danish: For brugervejledning, se pkt.
English: Replace the closure.
Danish: Sæt låget på igen.
English: • Pneumonia (severe chest infection)
Danish: • Dehydrering (væskemangel)
English: Posology
Danish: Brugeranvisning
English: 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Danish: 6.1 Hjælpestoffer
English: Temper tantrum
Danish: Mave-tarm-kanal
English: − is taking any of the following medicines (see section Other medicines and Sialanar):
Danish: − tager et eller flere af følgende lægemidler (se punktet "Brug af anden medicin sammen med Sialanar"): kaliumchlorid som en fast lægemiddelform, der tages gennem munden antikolinerge lægemidler.
English: Psychiatric disorders
Danish: KLINISKE OPLYSNINGER
English: Renal impairment Severe renal impairment (see section 4.3).
Danish: Nedsat nyrefunktion Svært nedsat nyrefunktion (se pkt.
English: Glycopyrronium treatment should be withdrawn until the constipation resolves.
Danish: Behandlingen med glycopyrronium skal afbrydes, indtil obstipationen har fortaget sig.
English: • Dry mouth
Danish: • Tilstoppet næse
English: In the paediatric population 5 µg/kg i.v.
Danish: Kg µg/kg)1
English: The majority of these side effects disappear within 1 to 2 days.
Danish: Hovedparten af disse bivirkninger forsvinder efter 1-2 dage.
English: This helps to protect against the disease caused by the virus.
Danish: Dette medvirker til at beskytte mod den sygdom, som virusset forårsager.
English: It contains a flu strain called A/Vietnam/1194/2004 (H5N1).
Danish: Det indeholder influenzastammen A/Vietnam/1194/2004 (H5N1).
English: Foclivia received a marketing authorisation valid throughout the EU on 19 October 2009.
Danish: Foclivia fik en markedsføringstilladelse med gyldighed i hele EU den 19. oktober 2009.
English: Further information can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/foclivia.
Danish: Yderligere information om Foclivia findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/foclivia.
English: The authorisation was based on the authorisation granted to Focetria in 2007 (‘informed consent').
Danish: Markedsføringstilladelsen var baseret på den tilladelse, som blev udstedt for Focetria i 2007 ("informeret samtykke").
English: The vaccine can only be obtained with a prescription and should be used according to official recommendations.
Danish: Vaccinen fås kun på recept og bør anvendes i henhold til de officielle anbefalinger.
English: Foclivia has been authorised under ‘exceptional circumstances'.
Danish: Foclivia er godkendt under "særlige omstændigheder".
English: When the person comes into contact with this or a similar virus, these antibodies, together with other components of the immune system, will be able to kill the viruses and help protect against the disease.
Danish: Når personen kommer i kontakt med dette eller et lignende virus, vil disse antistoffer sammen med andre komponenter i immunsystemet være i stand til at dræbe virusset og hjælpe med at beskytte mod sygdommen.
English: As for all medicines, data on the use of Foclivia are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Foclivia løbende overvåget.
English: Other information about Foclivia
Danish: Andre oplysninger om Foclivia
English: According to EMA's criteria, a pandemic preparedness vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
Danish: Ifølge EMA's kriterier skal en beredskabsvaccine frembringe en beskyttende mængde antistoffer hos mindst 70 % af personerne for at kunne anses for egnet.
English: The main measures of effectiveness were the levels of antibodies against the flu virus in the blood before vaccination, on the day of the second injection (day 22), and 21 days later (day 43).
Danish: Det primære mål for virkning var mængden af antistoffer mod influenzavirusset i blodet før vaccination, på datoen for anden injektion (dag 22) og 21 dage senere (dag 43).
English: However, if a pandemic has started, it may be appropriate to give the vaccine to these people, as long as facilities for resuscitation are available.
Danish: Hvis der er udbrudt en pandemi, kan det dog være hensigtsmæssigt at vaccinere sådanne personer, forudsat at der er genoplivningsudstyr til rådighed.
English: Vaccines work by preparing the immune system (the body's natural defences) to defend itself against a disease.
Danish: Vacciner virker ved at lære immunsystemet (kroppens naturlige forsvar), hvordan det skal forsvare sig mod en sygdom.
English: What measures are being taken to ensure the safe and effective use of Foclivia?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Foclivia?
English: Foclivia would be given according to official recommendations.
Danish: Foclivia gives i overensstemmelse med de officielle anbefalinger.
English: A flu pandemic occurs when a new type (strain) of flu virus can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Danish: En influenzapandemi forekommer, når der opstår en ny type (stamme) af et influenzavirus, der let kan spredes fra person til person, fordi de ikke har nogen immunitet (beskyttelse) mod den. En pandemi kan berøre de fleste lande og regioner i verden.
English: The European Medicines Agency decided that Foclivia's benefits are greater than its risk and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Foclivia opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Foclivia is a vaccine used in adults to protect against flu when a ‘pandemic' has been officially declared by the World Health Organization (WHO) or the European Union (EU).
Danish: Foclivia er en vaccine, der anvendes til at beskytte voksne mod influenza, når udbrud af en pandemi officielt er erklæret af Verdenssundhedsorganisationen (WHO) eller af Den Europæiske Union (EU).
English: Foclivia contains some parts of inactivated (killed) influenza (flu) virus.
Danish: Foclivia indeholder visse dele af inaktiveret (dræbt) influenzavirus.
English: Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because nobody has been exposed to it, and to which nobody is immune.
Danish: I stedet kan de fremstille en vaccine med en influenzavirusstamme, der specifikt udvælges, fordi ingen har været udsat for den, og ingen er immune over for den.
English: Before a pandemic starts, nobody knows which strain of flu virus will be involved, so companies cannot prepare the correct vaccine in advance.
Danish: Inden der udbryder en pandemi, er der ingen, som ved, hvilken influenzavirusstamme der forårsager den, så virksomhederne kan ikke på forhånd fremstille den korrekte vaccine.
English: Foclivia is given by injection into the upper arm muscle or the thigh in two doses, at least 3 weeks apart.
Danish: Foclivia gives ved injektion i overarms- eller lårmusklen i to doser med mindst tre ugers mellemrum.
English: Foclivia should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any substances found at trace levels in the vaccine, such as egg, chicken protein, kanamycin or neomycin (antibiotics), formaldehyde and cetyltrimethylammonium bromide (CTAB).
Danish: Foclivia bør ikke gives til personer, der har haft en anafylaktisk reaktion (en alvorlig overfølsomhedsreaktion) over for en af vaccinens komponenter eller øvrige stoffer, der findes på sporstofniveau, f.eks. æg, kyllingeprotein, kanamycin eller neomycin (antibiotika), formaldehyd og cetyltrimethylammoniumbromid (CTAB).
English: An overview of Foclivia and why it is authorised in the EU
Danish: En oversigt over Foclivia, og hvorfor det er godkendt i EU
English: Why is Foclivia authorised in the EU?
Danish: Hvorfor er Foclivia godkendt i EU?
English: What is Foclivia and what is it used for?
Danish: Hvad er Foclivia, og hvad anvendes det til?
English: The main study of Foclivia included 486 healthy people (a third of whom were over the age of 60) and compared the ability of two doses of Foclivia to trigger the production of antibodies (immunogenicity).
Danish: Hovedstudiet med Foclivia omfattede 486 raske forsøgspersoner (hvoraf en tredjedel var over 60 år), og her blev virkningen ved to forskellige doser af Foclivia sammenlignet, hvad angår dannelse af antistoffer (den immunogene virkning).
English: Twenty-one days after the second injection, 86% of the people receiving the vaccine with 7.5 micrograms haemagglutinin had levels of antibodies that would protect them against H5N1.
Danish: 21 dage efter den anden injektion havde 86 % af de personer, der havde fået en vaccine med 7,5 mikrogram hæmagglutinin, produceret antistofmængder, der var tilstrækkelige til at beskytte dem mod H5N1.
English: The study showed that Foclivia produced an antibody response that satisfies these criteria.
Danish: I studiet udløste Foclivia et antistofrespons, der opfylder disse kriterier.
English: The immune system will then be able to produce antibodies more quickly when it comes into contact with the virus again.
Danish: Immunsystemet kan således danne antistoffer hurtigere, når det eksponeres for det samme virus igen.
English: The most common side effects with Foclivia (which may affect up to 1 people in 10) are headache, sweating, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (redness, swelling, hardening, bruising, pain), fever, feeling unwell, tiredness and shivering.
Danish: De hyppigste bivirkninger ved Foclivia (der kan forekomme hos op til 1 ud af 10 personer) er hovedpine, svedtendens, ledsmerter, muskelsmerter, reaktioner på injektionsstedet (rødme, hævelse, hård hud, blå mærker og smerter), feber, utilpashed, træthed og kulderystelser.
English: Since Foclivia has been authorised under exceptional circumstances, the company that markets Foclivia will collect information on the safety and effectiveness of the final pandemic vaccine when it includes the flu strain responsible for a pandemic in the vaccine.
Danish: Da Foclivia er godkendt under særlige omstændigheder, skal den virksomhed, der markedsfører Foclivia, indsamle oplysninger om sikkerheden og virkningen ved den endelige pandemivaccine, når den influenzastamme, der forårsager en pandemi, inkluderes i vaccinen.
English: Side effects reported with Foclivia are carefully evaluated and any necessary action taken to protect people who receive Foclivia.
Danish: De indberettede bivirkninger ved Foclivia vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: During a pandemic, the virus strain in Foclivia will have to be replaced by the strain causing the pandemic before the vaccine can be used.
Danish: Under en pandemi skal virusstammen i Foclivia erstattes med den stamme, der forårsager pandemien, inden vaccinen kan bruges.
English: The vaccine also contains an ‘adjuvant' to increase the vaccine's effectiveness.
Danish: Vaccinen indeholder også en såkaldt adjuvans (en olieholdig forbindelse), som gør vaccinen mere effektiv.
English: What information is still awaited for Foclivia?
Danish: Hvilke oplysninger afventes der stadig for Foclivia?
English: When a person is given the vaccine, the immune system recognises the virus as ‘foreign' and makes antibodies against it.
Danish: Når en person vaccineres, opfatter immunsystemet virusset som fremmed og producerer antistoffer mod det.
English: The figure was 85% in people who received the 15-microgram dose.
Danish: Hos de personer, der fik 15 mikrogram, var den tilsvarende andel 85 %.
English: What are the risks associated with Foclivia?
Danish: Hvilke risici er der forbundet med Foclivia?
English: The participants received two injections of Foclivia, containing either 7.5 or 15 micrograms of haemagglutinin (a protein found in flu viruses), 21 days apart.
Danish: Deltagerne fik med 21 dages mellemrum to injektioner af Foclivia med enten 7,5 eller 15 mikrogram hæmagglutinin (et protein, der findes i influenzavira).
English: For the full list of all side effects of Foclivia, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Foclivia fremgår af indlægssedlen.
English: How is Foclivia used?
Danish: Hvordan anvendes Foclivia?
English: Recommendations and precautions to be followed by healthcare professionals and their patients for the safe and effective use of Foclivia have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Foclivia.
English: This means that, because the vaccine is a pandemic preparedness vaccine and does not yet contain the strain of flu virus that is causing a pandemic, it has not been possible to obtain full information about the final pandemic vaccine.
Danish: Det betyder, at det ikke har været muligt at indhente fyldestgørende oplysninger om den endelige pandemiske vaccine, da det er en pandemisk beredskabsvaccine, som endnu ikke indeholder den influenzavirusstamme, der forårsager en pandemi.
English: They test this vaccine to see how people react to it, allowing them to predict how people will react when the flu strain causing a pandemic is included in the vaccine.
Danish: Derved kan det forudsiges, hvordan mennesker vil reagere, når den influenzastamme, der er årsag til en pandemi, inkluderes i vaccinen.
English: How does Foclivia work?
Danish: Hvordan virker Foclivia?
English: This is a special type of vaccine that can be developed to help with the management of a future pandemic.
Danish: Foclivia er en pandemisk beredskabsvaccine, dvs. en særlig vaccinetype, der kan udvikles for at kontrollere en fremtidig pandemi.
English: What benefits of Foclivia have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Foclivia?
English: Foclivia contains some parts the H5N1 virus.The virus has been first inactivated so that it does not cause disease.
Danish: Foclivia indeholder visse dele af H5N1-virusset.
English: Whole virion influenza vaccine, inactivated containing antigen of pandemic strain*: A/California/7/2009 (H1N1)v 7.5 micrograms** per 0.5 ml dose * propagated in Vero cells (continuous cell line of mammalian origin) ** expressed in micrograms haemagglutinin.
Danish: Influenzavaccine, hele virion, inaktiveret, indeholder antigen af pandemisk stamme*: A/California/07/2009 (H1N1)v
English: Intramuscular use vial (glass) 0.5 ml
Danish: Hætteglas (glas) 0,5 ml
English: Packaging Content (concentration)
Danish: Emballage
English: Benefit/risk
Danish: Benefit/risk-forhold
English: Until June 2005, veralipride was authorised in Spain.
Danish: Indtil juni 2005 var veraliprid godkendt i Spanien.
English: It was first authorised in 1979 and is currently authorised in the EU in Belgium, France, Italy, Luxembourg and Portugal under the names Agreal and Agradil.
Danish: Det blev første gang godkendt i 1979, og i EU er det på nuværende tidspunkt godkendt i Belgien, Frankrig, Italien, Luxembourg og Portugal under navnene Agreal og Agradil.
English: Few data are available beyond 3 months, mostly in non comparative studies.
Danish: Der foreligger kun få data, der rækker ud over 3 måneder, og disse er hovedsagelig fra ikke-sammenlignende undersøgelser.
English: Produtos Farmacêuticos, S.A. PRT Empreendimento Lagoas Park - Edifício 72º e 3º Porto Salvo
Danish: Produtos Farmacêuticos, S.A. PRT Empreendimento Lagoas Park - Edificio 72° e 3° Porto Salvo
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING VERALIPRIDE (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF LÆGEMIDLER INDEHOLDENDE VERALIPRID (se bilag I)
English: The 27-year post-marketing period offers a long period of safety profile surveillance.
Danish: De 27 års markedsføring har givet mulighed for overvågning af sikkerhedsprofilen i lang tid.
English: • The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing veralipride
Danish: • udvalget behandlede indbringelsen i henhold til artikel 31 i Rådets direktiv 2001/83/EF, med senere ændringer, for lægemidler indeholdende veraliprid
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR WITHDRAWAL OF THE MARKETING AUTHORISATION PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSE FOR TILBAGEKALDELSE AF MARKEDSFØRINGSTILLADELSEN FREMLAGT AF EMEA
English: Lastly, QT-prolongation is a class-effect of dopamine-antagonists.
Danish: Endelig er forlænget QT-interval en klassevirkning af dopaminantagonister.
English: In addition, the Committee considered that the proposed risk minimisation activities were not able to reduce the risks to an acceptable level or predict which women may be at risk;
Danish: Udvalget tog desuden i betragtning, at de foreslåede tiltag til risikominimering ikke gør det muligt at mindske risiciene til et acceptabelt niveau eller forudsige, hvilke kvinder, der kan være udsat for risiko
English: Spain therefore withdrew veralipride's marketing authorisation on 27 June 2005.
Danish: Spanien tilbagekaldte derfor markedsføringstilladelsen for veraliprid den 27. juni 2005.