natgillin/translations-raw huggingface dataset:
Fluticasone furoate GSK sprayes ind i næsen.
When to use it and how much to use Fluticasone furoate GSK is sprayed into the nose as a fine mist.
Fluticasone furoate GSK må ikke sprayes ind i øjnene.
Fluticasone furoate GSK is not for use in the eyes.
Hvornår skal Fluticasone furoate GSK bruges? • 1 gang daglig • På samme tidspunkt hver dag På denne måde bliver dine symptomer behandlet døgnet rundt.
This will treat your symptoms throughout the day and night.
Nogle mennesker får først maksimal virkning efter flere dages brug.
How long Fluticasone furoate GSK takes to work Some people will not feel the full effects until several days after first using Fluticasone furoate GSK.
Hvis du har brugt for meget Fluticasone furoate GSK Kontakt lægen, skadestuen eller apoteket, hvis du har taget mere Fluticasone furoate GSK, end der står i denne information, eller mere end lægen har foreskrevet.
If you use more Fluticasone furoate GSK than you should Talk to your doctor or pharmacist.
Hvis du har glemt at bruge Fluticasone furoate GSK • Hvis du glemmer en dosis, skal du tage den, når du kommer i tanke om det.
If you forget to use Fluticasone furoate GSK • If you miss a dose, take it when you remember. • If it is nearly the time for your next dose, wait until then.
Spørg lægen eller apoteket, hvis der er noget, du er i tvivl om eller føler dig usikker på.
If you have any further questions on the use of this product, ask you doctor or pharmacist.
Næsesprayen • Medicinen er i en glasflaske i en kappe af plastic. • Den indeholder enten 30, 60 eller 120 pust. • I vinduet på siden af næsesprayen kan du se, hvor meget medicin der er tilbage.
19 How to test the nasal spray before use The nasal spray • Your medicine comes in a glass bottle inside a plastic casing. • The glass bottle contains either 30, 60 or 120 sprays. • A window on the side of the casing allows you to see how much medicine is left.
20 Sådan skal du bruge næsesprayen
20 Using your nasal spray
Tør næsestudsen og indersiden af hætten – se billede e og f.
After each use, wipe the nozzle and the inside of the cap – see pictures e and f.
Der skal ikke bruges vand – kun en ren og tør klud.
Don ’ t use water to do this, wipe with a clean, dry tissue.
Hvis du har brugt for meget Fluticasone furoate GSK Kontakt lægen, skadestuen eller apoteket.
If you use more Fluticasone furoate GSK than you should Talk to your doctor or pharmacist.
Hvis du har glemt at bruge Fluticasone furoate GSK • Hvis du glemmer en dosis, skal du tage den, når du kommer i tanke om det. • Hvis det er tæt på næste dosis, skal du blot vente og tage den.
If you forget to use Fluticasone furoate GSK • If you miss a dose take it when you remember. • If it is nearly the time for your next dose, wait until then.
Fluticasone furoate GSK kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Fluticasone furoate GSK can cause side effects, although not everybody gets them.
Meget almindelig (det sker hos flere end 1 ud af 10 patienter) • Næseblod (som regel let), især hvis du bruger Fluticasone furoate GSK hele tiden i over 6 uger.
Very common side effects (These can affect more than 1 person in 10) • Nosebleeds (generally minor), particularly if you use Fluticasone furoate GSK for more than 6 weeks continuously.
SÅDAN OPBEVARER DU FLUTICASONE FUROATE GSK
HOW TO STORE FLUTICASONE FUROATE GSK
Brug ikke Fluticasone furoate GSK efter den udløbsdato, der står på pakningen.
Do not use Fluticasone furoate GSK after the expiry date which is stated on the label and carton.
Fluticasone furoate GSK næsespray skal bruges senest to måneder efter flasken blev åbnet første gang.
Fluticasone furoate GSK nasal spray should be used within 2 months after first opening.
Fluticasone furoate GSK indeholder:
What Fluticasone furoate GSK contains The active substance is fluticasone furoate.
Fluticasone furoate GSK ’ udseende og pakningsstørrelse Medicinen er en hvid suspension i brun glasflaske med pumpefunktion.
What Fluticasone furoate GSK looks like and contents of the pack The medicine is a white nasal spray suspension contained in an amber glass bottle, fitted with a pump.
Fluticasone furoate GSK fås i pakninger på 30, 60 og 120 pust.
Fluticasone furoate GSK is available in pack sizes 30, 60 and 120 sprays.
Fremstiller Glaxo Operations UK Limited (Glaxo Wellcome Operations) Harmire Road Barnard Castle County Durham, DL12 8DT
Glaxo Operations UK, Ltd, (trading as Glaxo Wellcome Operations) Harmire Road Barnard Castle County Durham DL12 8DT United Kingdom
22 Storbritannien
22 For information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
23 GlaxoSmithKline S. p. A.
23 Italia GlaxoSmithKline S. p. A.
GlaxoSmithKline Oy Puh/ Tel: + 358 (0) 10 30 30 30 Finland. tuoteinfo@ gsk. com
Suomi/ Finland GlaxoSmithKline Oy Puh/ Tel: + 358 (0)10 30 30 30 Finland. tuoteinfo@gsk. com
Du kan finde yderligere information om Fluticasonfuroat GSK på Det Europæiske Lægemiddelagenturs (EMEA’ s) hjemmeside http: // www. emea. europa. eu /.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http: / /www. emea. europa. eu/
Det er en injektionsvæske, suspension, der indeholder visse dele (de ydre membraner) af influenzavirus.
It is a suspension for injection that contains some parts (outer membranes) of the influenza (flu) virus.
Vaccinen indeholder influenzastammen A/ Viet Nam/ 1194/ 2004 (H5N1).
It contains a flu strain called A/ Viet Nam/ 1194/ 2004 (H5N1).
Focetria er en vaccine, der kun må bruges, når udbrud af en pandemi officielt er erklæret af Verdenssundhedsorganisationen (WHO) eller af Den Europæiske Union (EU).
Focetria is a vaccine that can only be used once a flu ‘ pandemic’ has been officially declared by the World Health Organization (WHO) or European Union (EU).
Udbrud af en influenzapandemi forekommer, når der opstår en ny type (stamme) af et influenzavirus, der let smitter fra menneske til menneske, fordi mennesker ikke er immune over for den.
A flu pandemic occurs when a new type (strain) of flu virus emerges that can spread easily from person to person because people have no immunity (protection) against it.
Focetria vil da blive udleveret i henhold til officielle anbefalinger.
Focetria would be given according to official recommendations.
Focetria gives to gange med mindst tre ugers mellemrum.
Focetria is given in two doses, at least three weeks apart.
Focetria er en "modelvaccine".
Focetria is a ‘ mock-up’ vaccine.
Først når pandemien bryder ud, ved man, hvilken influenzavirusstamme, der forårsager den.
Before a pandemic starts, nobody knows which strain of flu virus will be involved, so companies cannot prepare the correct vaccine in advance.
Vaccinen kan derfor ikke fremstilles på forhånd.
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.
I stedet kan firmaerne fremstille en vaccine med en influenzavirusstamme, der er udvalgt efter, at ingen personer har været udsat for smitte med den, og ingen er immune.
They can 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.
Firmaerne kan afprøve vaccinen på mennesker for at se, hvordan de reagerer på den.
When a person is given the vaccine, the immune system recognises the virus as ‘ foreign’ and makes antibodies against it.
Derved kan det forudsiges, hvordan mennesker vil reagere på en vaccine med den influenzastamme, der er årsag til en pandemi.
Focetria contains small amounts of parts of a virus called H5N1.
Vacciner virker ved at "lære" immunsystemet (organismens naturlige forsvar), hvordan det skal forsvare organismen mod sygdommen.
The virus has been first inactivated (killed) so that it does not cause any disease.
Når man bliver vaccineret, opfatter immunsystemet virus som "fremmede" og producerer antistoffer mod dem.
The outer membranes that contain the ‘ surface antigens ’ (proteins on the outer membrane of the virus that the body recognises as foreign) have then been extracted and purified.
Derefter vil immunsystemet fremover kunne producere antistoffer hurtigere, hvis det møder samme virus igen.
The vaccine also contains an ‘ adjuvant ’ (a compound containing oil) to stimulate a better response.
Derved er man bedre beskyttet mod sygdommen.
If a pandemic starts, the virus strain in Focetria will be replaced by the strain causing the pandemic before the vaccine can be used.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Focetria indeholder små mængder af viruset H5N1.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Focetria been studied?
Virkningerne af Focetria blev først testet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Focetria were first tested in experimental models before being studied in humans.
Hovedundersøgelsen af Focetria omfattede 486 raske personer (en tredjedel over 60 år) og sammenlignede evnen af to forskellige doser af Focetria til at udløse produktion af antistoffer (den immunogene virkning).
The main study of Focetria included 486 healthy subjects (a third of whom were over the age of 60) and compared the ability of two doses of Focetria to trigger the production of antibodies (immunogenicity).
Deltagerne fik med 21 dages mellemrum to injektioner af Focetria med enten 7, 5 eller 15 mikrogram hæmagglutinin (et protein, der findes i influenzavirus).
The participants received two injections of Focetria, containing either 7.5 or 15 micrograms of haemagglutinin (a protein found in flu viruses), 21 days apart.
Behandlingens virkning blev hovedsagelig bedømt på mængden af antistoffer mod influenzaviruset i patienternes blod dels før vaccinationen, dels på dagen for den anden injektion (dag 22) og dels 21 dage senere (dag 43).
The main measures of effectiveness were the levels of antibodies against the flu virus in the patients’ blood before vaccination, on the day of the second injection (day 22), and 21 days later (day 43).
Hvilken fordel viser undersøgelserne, der er ved Focetria?
What benefit has Focetria shown during the studies?
I undersøgelsen udløste Focetria en antistofrespons, der opfylder disse kriterier.
The study showed that Focetria produced an antibody response that satisfies these criteria.
21 dage efter den anden injektion havde 86% af de personer, der havde fået en vaccine med 7, 5 mikrogram hæmagglutinin, tilstrækkeligt med antistof til at være beskyttet mod H5N1.
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.
Hos de patienter, der fik 15 mikrogram, var den tilsvarende andel 85%.
The figure was 85% in the patients who received the 15-micrograms dose.
De hyppigste bivirkninger af Focetria (som ses hos flere end 1 ud af 10 patienter) er hovedpine, svedtendens, ledsmerter, muskelsmerter, reaktioner på injektionsstedet (rødme, hævelse, hårdhed, blå mærker, smerte), feber, utilpashed, træthed og kulderystelser.
The most common side effects with Focetria (seen in between 1 and 10 people in 100) are headache, sweating, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (redness, swelling, hardening, bruising, pain), fever, malaise (feeling unwell), fatigue (tiredness) and shivering.
Den fuldstændige liste over de indberettede bivirkninger for Focetria fremgår af indlægssedlen.
For the full list of all side effects reported with Focetria, see the Package Leaflet.
Focetria bør ikke gives til patienter, der har haft en anafylaktisk reaktion (en svær overfølsomhedsreaktion) over for nogen af vaccinens komponenter eller over for nogen af de sporstoffer, den indeholder, f. eks. æg, kyllingeprotein, kanamycin eller neomycinsulfat (antibiotika), formaldehyd, cetyltrimethylammoniumbromid (CTAB) eller polysorbat 80.
Focetria should not be given to patients 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 eggs, chicken protein, kanamycin or neomycin sulphate (two antibiotics), formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Focetria opvejer risiciene til forebyggelse af influenza ved en officielt erklæret pandemisk situation.
The Committee for Medicinal Products for Human Use (CHMP) decided that Focetria’ s benefits are greater than its risks for the prophylaxis of influenza in an officially declared pandemic situation.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Focetria.
The committee recommended that Focetria be given marketing authorisation.
Focetria er godkendt under "særlige omstændigheder".
Focetria has been authorised under “ Exceptional Circumstances”.
Det vil sige, at da man ikke kender den influenzavirusstamme, der eventuelt vil forårsage en pandemi, har det ikke været muligt at skaffe fuldstændige oplysninger om den fremtidige vaccine til brug mod pandemien.
This means that because the strain of flu virus that may cause a pandemic is not known, it has not been possible to obtain full information about the future pandemic vaccine.
Hvilke oplysninger om Focetria afventes stadig?
What information is still awaited for Focetria?
Hvis der udsendes en erklæring om, at der er udbrudt en pandemi, skal det firma, der fremstiller Focetria, tilsætte den pågældende influenzastamme til vaccinen.
If a pandemic is declared, the company that makes Focetria will include the flu strain responsible in the vaccine.
Firmaet skal da indsamle oplysninger om sikkerhed og virkning af den endelige vaccine til brug mod pandemien, og skal indsende oplysningerne til CHMP til vurdering.
It will then collect information on the safety and effectiveness of the final pandemic vaccine, and submit this to the CHMP for evaluation.
Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Focetria?
Which measures are being taken to ensure the safe use of Focetria?
Oplysningerne skal omfatte
If Focetria is used during a pandemic, the company that makes it will collect information on the safety of the vaccine while it is being used.
vaccinens bivirkninger og sikkerheden hos børn, gravide, meget syge patienter og personer med nedsat immunforsvar.
This will include information on its side effects and its safety in children, pregnant women, patients with severe conditions, and people who have problems with their immune systems.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Focetria til Novartis Vaccines and Diagnostics S. r. l. den 2. maj 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for Focetria to Novartis Vaccines and Diagnostics S. r. l. on 2 May 2007.
Den fuldstændige EPAR for Focetria kan ses her.
The full EPAR for Focetria can be found here.
Dette sammendrag blev sidst ajourført i 05- 2007.
This summary was last updated in 05-2007.
Focetria 15 µg / ml
15 µg / ml
Fyldt injektionssprøjte (glas) 0, 5 ml
pre-filled syringe (glass)
Hætteglas (glas) 0, 5 ml (1 dosis = 0, 5 ml)
0.5 ml (1 dose = 0.5ml)
Hætteglas (glas) 5, 0 ml (1 dosis = 0, 5 ml)
5.0 ml (1 dose = 0.5 ml)
10 hætteglas (multidosis:
10 vials (multidose:
10 doser)
10 doses)
Focetria injektionsvæske, suspension i fyldt injektionssprøjte
Focetria suspension for injection in pre-filled syringe Pandemic influenza vaccine (surface antigen, inactivated, adjuvanted)
Influenzavirus overfladeantigen (hæmagglutinin og neuraminidase) * af følgende stamme:
Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:
0, 5 ml dosis
7.5 micrograms** per 0.5 ml dose
* dyrket i æg ** udtrykt i mikrogram hæmagglutinin.
* propagated in eggs ** expressed in microgram haemagglutinin.
Adjuvans MF59C. 1, som indeholder: squalen polysorbat 80 sorbitantrioleat
polysorbate 80 sorbitan trioleate
9, 75 milligram 1, 175 milligram 1, 175 milligram
This vaccine complies with the WHO recommendations and EU
Denne vaccine opfylder WHO’ s anbefalinger og EU’ s bestemmelser for pandemien.
decision for the pandemic.
4. 2 og 5. 1).
Pandemic influenza vaccine should be used in accordance with Official Guidance (see sections 4.2 and 5.1).
Focetria er vurderet hos voksne i alderen 18- 60 år og ældre over 60 år efter vaccination dag 0 og dag 21.
Focetria has been evaluated in adults aged 18-60 years and elderly over 60 years following a 0, 21 day schedule.
Der bør gives en ny vaccinedosis efter et interval på mindst 3 uger.
A second dose of vaccine should be given after an interval of at least 3 weeks.
Vaccinen skal injiceres intramuskulært i musculus deltoideus.
Immunisation should be carried out by intramuscular injection into the deltoid muscle.
Der foreligger ingen data for unge under 18 år eller for børn.
No data are available in subjects below 18 years or in children.
Sundhedspersonalet skal derfor vurdere fordele og eventuelle risici ved administration af vaccinen til denne population.
Therefore health care providers need to assess the benefits and potential risks of administering the vaccine in that population.
4. 6.
For pregnant women, see section 4.6.
Anamnese med anafylaktisk (dvs. livstruende) reaktion på ethvert indholdsstof eller spor af æg, kyllingeproteiner, kanamycin - og neomycinsulfat, formaldehyd og cetyltrimethylammoniumbromid (CTAB) i denne vaccine..
History of an anaphylactic (i. e. life-threatening) reaction to any of the constituents or trace residues of eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB) of this vaccine.
Se pkt.
However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need.
4. 4. vedrørende Særlige advarsler og forsigtighedsregler vedrørende brugen.
See section 4.4. for Special warnings and special precautions for use.
Der bør udvises forsigtighed, når denne vaccine gives til personer med kendt overfølsomhed (ud over anafylaktiske reaktioner) over for det aktive stof, over for et eller flere af hjælpestofferne, over for æg, kyllingeproteiner, kanamycin - og neomycinsulfat, formaldehyd og cetyltrimethylammoniumbromid (CTAB).
Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients and to eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB).
Vaccinen må under ingen omstændigheder gives intravaskulært eller subkutant.
The vaccine should under no circumstances be administered intravascularly or subcutaneously.
5. 1).
A protective response may not be induced in all vaccines (see section 5.1).
Focetria bør ikke gives samtidig med andre vacciner.
Focetria should not be given at the same time as other vaccines.
Den immunologiske respons kan reduceres, hvis patienten behandles med immunhæmmere.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Efter influenzavaccination er der observeret falske positive resultater i serologiske test, som har anvendt ELISA- metoden til at påvise antistoffer mod HIV- 1, Hepatitis C og specielt HTLV- 1.
Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed.
Resultaterne afvises af Western Blot- teknikken.
The Western Blot technique disproves the results.
De forbigående falsk- positive reaktioner kan skyldes vaccinens IgM- respons.
The transient false positive reactions could be due to the IgM response by the vaccine.
Der er ikke genereret dokumentation med Focetria hos gravide.
No data have been generated with Focetria in pregnant women.
Derfor skal sundhedspersonalet vurdere fordele og potentielle risici ved administration af vaccinen til gravide kvinder og tage officielle anbefalinger med i vurderingen.
Therefore health care providers need to assess the benefits and potential risks of administering the vaccine to pregnant women taking into consideration official recommendations.
Data fra vaccinationer med sæsonmæssig interpandemisk, inaktiverede, trivalente vacciner hos gravide kvinder tyder ikke på, at uønskede virkninger hos fosteret og moderen skyldtes vaccinen.
Data from vaccinations with seasonal interpandemic inactivated trivalent vaccines in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine.
Det er usandsynligt, at Focetria påvirker evnen til at føre motorkøretøj og betjene maskiner.
Focetria is unlikely to produce any effect on the ability to drive and use machines.
I kliniske studier med forskellige formuleringer (H5N3, H9N2 og H5N1) fik 542 personer kandidatvaccinen.
In clinical trials with different formulations (H5N3, H9N2 and H5N1) 542 subjects were exposed to thecandidate vaccine.
Heraf fik 464 personer mock- up- vaccinen (A/ H5N1).
Of theses subjects, 464 subjects received the mock-up vaccine (A/ H5N1).
I de kliniske studier med pandemivaccinen var de fleste reaktioner lette, kortvarige og kvalitativt på samme niveau som dem, der blev induceret af konventionelle sæson- influenzavacciner.
From the clinical trials with the pandemic vaccine, most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by conventional seasonal influenza vaccines.
3 let forøget hyppighed af lokale reaktioner (især lette smerter) sammenlignet med konventionelle, ikke - adjuverede influenzavacciner.
It is widely accepted that the adjuvant effect leading to increased immunogenicity is associated with a slightly higher frequency of local reactions (mostly mild pain) compared with conventional, nonadjuvanted influenza vaccines.
5. 1 for yderligere information om mock- up vacciner).
3 Adverse reactions from clinical trials with the mock-up vaccine are listed below (see section 5.1 for more information on mock-up vaccines).
Inden for hver enkelt frekvensgruppe skal bivirkningerne opstilles efter, hvor alvorlige de er.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness:
Nervesystemet Almindelig (> 1/ 100, < 1/ 10): hovedpine
Nervous system disorders Common (> 1/ 100, < 1/ 10): headache
Hud og subkutane væv Almindelig (> 1/ 100, < 1/ 10 svedtendens
Skin and subcutaneous tissue disorders Common (> 1/ 100, < 1/ 10): sweating
Knogler, led, muskler og bindevæv Almindelig (> 1/ 100, < 1/ 10): led- og muskelsmerter
Muscoskeletal, connective tissue and bone disorders Common (> 1/ 100, < 1/ 10): arthralgia and myalgia
Feber, utilpashed, træthed og kulderystelser.
General disorders and administration site conditions Common (> 1/ 100, < 1/ 10): injection site redness, injection site swelling, injection site induration, injection site ecchymosis and injection site pain, fever, malaise, fatigue and shivering
Disse reaktioner forsvinder som regel inden for 1- 2 dage uden behandling.
These reactions usually disappear within 1-2 days without treatment.
Ved bivirkningsovervågning efter markedsføring af adjuverede, interpandemiske, trivalente vacciner med lignende sammensætning som Focetria (overfladeantigen, inaktiveret, adjuveret med MF59C. 1) er der rapporteret følgende bivirkninger:
From Post-marketing surveillance with adjuvanted interpandemic trivalent vaccines with the similar composition of Focetria (surface antigen, inactivated, adjuvanted with MF59C.1), the following adverse events have been reported:
Ikke almindelig (> 1/ 1. 000, < 1/ 100):
Uncommon (> 1/ 1,000, < 1/ 100):