FrancophonIA/ELRC3.0 huggingface dataset:
English: If you take any medicines that reduce immunity to infections or have any other type of treatment (such as radiotherapy) that affects the immune system, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg can still be given but your response to the vaccine may be poor.
Danish: Hvis du tager medicin, som nedsætter immunforsvaret, eller får en anden behandling (fx strålebehandling), som påvirker immunforsvaret, kan Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram stadig gives, men virkningen af vaccinen kan være nedsat.
English: • Pain, redness, swelling or a hard lump at the injection site
Danish: • Smerter, rødmen, hævelse eller en hårdhed, hvor indsprøjtningen blev givet
English: Regardless of whether one or two doses of priming vaccine had been given 6 months earlier, the seroprotection rates against A/Indonesia were >80% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 and the seroprotection rates against A/Vietnam were >90% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005.
Danish: Uanset om der var blevet givet en eller to primære vaccinedoser 6 måneder tidligere, var seroprotektionsraterne > 80 % mod A/Indonesia efter en dosis AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 og seroprotektionsraterne > 90 % mod A/Vietnam efter en dosis af AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Indonesia/05/2005.
English: However, if coadministration with another vaccine is considered to be essential, the vaccines should be injected into separate limbs.
Danish: Hvis samtidig vaccination med andre vacciner er nødvendigt, gives den anden vaccine i den anden arm.
English: GlaxoSmithKline (GSK) SRL Tel: + 40 (0)21 3028 208
Danish: GlaxoSmithKline (GSK) SRL Tel: + 40 (0)21 3028 208 www.gsk.ro
English: Please tell your doctor if you are/may be pregnant or intend to become pregnant, or if you are breast-feeding and follow his advice.
Danish: Hvis du er gravid, forsøger at blive gravid eller ammer, fortæl det til lægen,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 25 VIALS OF EMULSION
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNING MED 25 HÆTTEGLAS INDEHOLDENDE EMULSION
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine.
Danish: Tidligere anafylaktisk (dvs. livstruende) reaktion over for et eller flere af stofferne eller over for spor af reststoffer (æg og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulphat og natriumdeoxycholat) i denne vaccine.
English: Common (these may occur with up to 1 in 10 doses of the vaccine):
Danish: Almindelige (det sker efter op til 1 ud af 10 vaccinedoser):
English: Uncommon (these may occur with up to 1 in 100 doses of the vaccine):
Danish: Ikke almindelige (det sker efter op til 1 ud af 100 vaccinedoser):
English: One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 administered after one or two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004.
Danish: En dosis AS03-adjuveret vaccine indholdende 3,75 μg HA fra A/Indonesia/05/2005 administreret efter en eller to doser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004.
English: In 152 subjects aged > 60 years the anti-HA antibody seroprotection and seroconversion rates against A/Indonesia/5/2005 at day 42 after two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 were 23% and the seroconversion factor was 2.7.
Danish: Hos 152 personer i alderen over 60 år var anti-HA-antistof-serobeskyttelsen og serokonverteringsraten 23 % mod A/Indonesia/05/2005 på dag 42 efter to doser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 og serokonverteringsfaktoren var 2,7.
English: A minor infection such as a cold should not be a problem, but your doctor will advise whether you can still be vaccinated with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Danish: En mindre infektion, fx forkølelse, er normalt ikke noget problem, men lægen afgør, om du kan vaccineres med Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram.
English: In another clinical study, 152 subjects aged > 60 years (stratified in ranges from 61 to 70, 71 to 80 and > 80 years of age) received either a single or a double dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days.
Danish: I et andet klinisk forsøg fik 152 personer over 60 år (stratificeret i grupper fra 61-70 år, 71-80 år og > 80 år) enten en enkelt- eller en dobbeltdosis AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1) på dag 0 og 21.
English: • if you have had any allergic reaction other than a sudden life threatening allergic reaction to any ingredient contained in the vaccine, to thiomersal, to egg and chicken protein, ovalbumin formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
Danish: • hvis du har haft andre overfølsomhedsreaktioner end den pludselige, livstruende overfølsomhedsreaktion, over for et af indholdsstofferne i vaccinen, thiomersal, æg og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulphat (antibiotikum) eller natriumdeoxycholat (se afsnit 6, der giver yderligere oplysninger)
English: • Narrowing or blockage of blood vessels with kidney problems
Danish: • Nyreproblemer, som følge af indsnævring eller blokering af blodkar.
English: Suspension for emulsion for injection 50 vials: suspension
Danish: 50 hætteglas: suspension
English: If you are older than 80 years of age, you may receive two double injections of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Danish: Hvis du er over 80 år, skal du muligvis have to dobbeltindsprøjtninger med Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram.
English: GlaxoSmithKline AS Tlf: + 47 22 70 20 00 firmapost@gsk.no
Danish: Tlf: + 47 22 70 20 00 firmapost@gsk.no
English: - two packs of 25 vials (type I glass) of 2.5 ml emulsion (10 x 0.25 ml doses) with a stopper (butyl rubber).
Danish: - to pakker med 25 hætteglas (type I-glas) hver indeholdende 2,5 ml emulsion (10 x 0,25 ml
English: The doctor or nurse will give Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg as an injection into your upper arm muscle.
Danish: Lægen eller sygeplejersken vil give dig Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram som en indsprøjtning i overarmsmusklen.
English: In a different study in 50 subjects aged 18-60 years the anti-HA antibody seroprotection rates 21 days after the second dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 were 20% against A/Indonesia/5/2005, 35% against A/Anhui/01/2005 and 60% against A/Turkey/Turkey/1/2005.
Danish: I et andet forsøg med 50 personer i alderen 18-60 år var anti-HA-antistof-seroprotektionsraten 20 % mod A/Indonesia/05/2005 21 dage efter den anden dosis AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004, 35 % mod A/Anhui/01/2005 og 60 % mod A/Turkey/Turkey/1/2005.
English: The second dose should be given after an interval of at least three weeks.
Danish: Det anbefales at den anden vaccination bliver givet mindst tre uger efter den første vaccination.
English: Immune response againstA/Vietnam/1194/2004 :
Danish: Immunrespons mod A/Vietnam/1194/2004:
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is a vaccine for use in adults from 18 years old.
Danish: Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram er en vaccine, som anvendes til voksne i alderen fra 18.
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should be used in accordance with official guidance.
Danish: Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram bør anvendes i overensstemmelse med officielle retningslinjer.
English: In another clinical study, 39 subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 fourteen months after they had received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 administered on day 0 and day 21.
Danish: I et andet klinisk forsøg fik 39 personer i alderen 18-60 år en dosis AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Indonesia/05/2005 fjorten måneder efter at have fået to doser AS03adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 på dag 0 og 21.
English: In a clinical study, subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from either A/Vietnam/1194/2004 or Indonesia/5/2005 six months after they had received one or two priming doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 on day 0 or on days 0 and 21 respectively.
Danish: I et klinisk forsøg fik personer i alderen 18-60 år en dosis AS03-adjuveret vaccine indeholdende 3,75 μg HA fra enten A/Vietnam/1194/2004 eller A/Indonesia/05/2005 6 måneder efter administration af en eller to primære doser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 på henholdsvis dag 0 eller på dag 0 og 21.
English: Tell the doctor requesting these tests that you have recently received Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals
Danish: Fortæl til lægen, som har bedt om at få sådanne blodprøver foretaget, at du for nyligt har fået Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram.
English: Emulsion for emulsion for injection 25 vials: emulsion
Danish: 25 hætteglas: emulsion
English: GlaxoSmithKline Biologicals Branch of SmithKline Beecham Pharma GmbH & Co. KG Zirkustraße 40, D-01069 Dresden Germany
Danish: KG Zirkustraße 40, D-01069 Dresden Tyskland
English: For further information, see sections 4.4 and 5.1.
Danish: 4.4 og 5.1.
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should under no circumstances be administered intravascularly or intradermally.
Danish: Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram må under ingen omstændigheder gives intravaskulært eller intradermalt.
English: Do not have Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg if any of the above apply to you.
Danish: Du må ikke få Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram hvis noget af ovennævnte passer på dig.
English: Like all medicines, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg can cause side effects, although not everybody gets them.
Danish: Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Danish: Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: Therefore, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is not intended to be given at the same time as other vaccines.
Danish: Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram bør derfor ikke gives samtidig med andre vacciner.
English: The potential benefits to the mother and risks to the infant should be considered before administering Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg during lactation.
Danish: De potentielle fordele for moderen og risikoen for barnet skal overvejes før administration af Prepandemisk influenzavaccine GlaxoSmithKline i ammeperioden.
English: Uncommon: Generalised skin reactions including urticaria
Danish: Ikke almindelig: Generaliserede hudreaktioner inkl.
English: There is no information on the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg in pregnant or breast-feeding women.
Danish: Der findes ingen oplysninger om brugen af Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram til gravide eller ammende kvinder.
English: No post-marketing surveillance data are available following Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg administration.
Danish: Der findes ingen data fra overvågning efter markedsføring for Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram .
English: A complete vaccination course with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg consists of two doses.
Danish: Et fuldstændigt vaccinationsprogram med Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline 3,75 μg består af to doser.
English: You will receive two doses of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Danish: Du vil få to vaccinationer af Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram.
English: PSUR submission when Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is used during the influenza pandemic:
Danish: Indsendelse af PSUR når Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram administreres under en influenzapandemi:
English: * haemagglutinin
Danish: * hæmagglutinin
English: These side effects may occur with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Danish: Disse bivirkninger kan også opstå efter anvendelse af Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram.
English: Booster seroconversion rate2
Danish: Boosterserokonverteringsrate2
English: One pack of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg consists of:
Danish: En pakke Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram består af:
English: No data have been generated in pregnant women with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg or with any other vaccine that contains the AS03 adjuvant.
Danish: Der foreligger ingen data om Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram eller andre vacciner, der indeholder AS03adjuvans til gravide kvinder.
English: In the event of other variation being observed, discard the vaccine.
Danish: Hvis den rekonstituerede vaccine ser anderledes ud, bør den kasseres.
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension and emulsion for emulsion for injection.
Danish: Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram suspension og emulsion til injektionsvæske, emulsion.
English: If a double dose is given, the injections should be given into opposite limbs.
Danish: Før injektion skal de to væsker sammenblandes.
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg consists of two containers:
Danish: Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram består af to hætteglas:
English: • Sleeplessness
Danish: • Søvnighed
English: Take special care with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg:
Danish: Vær ekstra forsigtig med at anvende Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram:
English: Against A/Indonesia 21 days after boosting with A/Indonesia
Danish: Mod A/Indonesia 21 dage efter boosterdosis A/Indonesia N= 49 Efter en primær Efter to primære Efter en primær Efter to primære dosis doser dosis doser
English: There are no data on the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg given at the same time as other vaccines.
Danish: Der findes ingen oplysninger om samtidig brug af Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram og andre vacciner.
English: How to store Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Danish: - Lægen har ordineret Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret,
English: What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg contains
Danish: Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram indeholder
English: • Low blood platelet count which can result in bleeding or bruising
Danish: • Overfølsomhedsreaktioner, der kan føre til alvorligt blodtryksfald, og som, hvis de ikke behandles, kan føre til kollaps, bevidstløshed og dødsfald.
English: Split influenza virus inactivated, containing antigen* equivalent to:
Danish: Efter rekonstitution indeholder 1 dosis (0,5 ml): Split influenzavirus, inaktiveret, indeholdende antigen svarende til:
English: The volume of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg (5 ml) after mixing corresponds to 10 doses of vaccine.
Danish: Efter rekonstitution svarer indeholdet af Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram (5 ml) til 10 vaccinedoser.
English: What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg looks like and contents of the pack
Danish: Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram - udseende og pakningsstørrelse
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Danish: Biologicals 3,75 mikrogram suspension og emulsion til injektionsvæske, emulsion Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret)
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension for emulsion for injection IM
Danish: Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram suspension til injektionsvæske, emulsion.
English: Emulsion for emulsion for injection for Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg
Danish: Emulsion til Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram injektionsvæske, emulsion
English: Norge
Danish: KG
English: The side effects listed below have occurred with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg in clinical studies:
Danish: Nedennævnte bivirkninger er set i kliniske forsøg med vaccination med Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram.
English: How to store Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg
Danish: Det skal du vide om Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram
English: Only do this once.
Danish: Det må du kun gøre én gang.
English: Wait 5 to 15 minutes;
Danish: Vent 5-15 minutter
English: This is because there is limited information in this group of people.
Danish: Det er, fordi der er begrænset information om denne gruppe.
English: Note: There were some differences in analysis methods across the 3 studies.
Danish: Bemærk: Der var nogle forskelle i analysemetoder på tværs af de 3 studier.
English: Date of first authorisation: 13 April 2012 Date of latest renewal: 11 January 2017
Danish: Dato for første markedsføringstilladelse: 13. april 2012 Dato for seneste fornyelse: 11. januar 2017
English: Patients should be advised to carefully read them.
Danish: Patienterne skal rådes til at læse dem grundigt igennem.
English: There are insufficient data in this population to support a recommendation for or against dose adjustment.
Danish: Der foreligger ikke tilstrækkelige data for denne population til at støtte en anbefaling for eller imod dosisjustering.
English: You should avoid using this medicine if you are pregnant.
Danish: Du bør undgå at bruge dette lægemiddel, hvis du er gravid.
English: Absolute mL
Danish: Absolut ml
English: - Worsening of symptoms.
Danish: - Forværring af symptomer.
English: - Use a new inhaler each week.
Danish: - Brug en ny inhalator hver uge.
English: There are no data available for children under 12 years of age.
Danish: Der foreligger ingen data for børn under 12 år.
English: Absolute % predicted Relative % predicted
Danish: Relativ forventet %
English: Dornase alfa (if applicable) 5.
Danish: Dornase alfa (hvis relevant) 5.
English: This effect was not noted in any other species and did not result in clinical signs.
Danish: Denne virkning blev ikke bemærket hos andre arter og resulterede ikke i kliniske tegn.
English: The first dose is taken in 4 steps:
Danish: Den første dosis tages i 4 trin:
English: Your doctor will tell you how long to use this medicine for.
Danish: Lægen vil fortælle dig, hvor længe du skal bruge medicinen.
English: Frequencies are defined as:
Danish: Hyppighederne er defineret således:
English: There are also links to other websites about rare diseases and treatments.
Danish: Der er også links til websites om sjældne sygdomme og om, hvordan de behandles.
English: This happens commonly, which may affect up to 1 in 10 people.
Danish: Det er almindeligt og rammer op til 1 ud af 10
English: - Have the evening dose at least 2 to 3 hours before you go to bed.
Danish: - Du skal tage aftendosen mindst 2-3 timer, før du går i seng.
English: For patients receiving several respiratory therapies, the recommended order is:
Danish: For patienter, som får flere respirationsbehandlinger, er den anbefalede rækkefølge:
English: Adults 18 years of age and over
Danish: Voksne på 18 år og derover
English: • acute bleeding ≥240 ml in a 24-hour period
Danish: • akut blødning ≥240 ml inden for 24 timer