natgillin/translations-raw huggingface dataset:
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. 
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.
• 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) 
• 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.
• Nyreproblemer, som følge af indsnævring eller blokering af blodkar. 
• Narrowing or blockage of blood vessels with kidney problems
50 hætteglas: suspension 
Suspension for emulsion for injection 50 vials: suspension
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. 
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.
- to pakker med 25 hætteglas (type I-glas) hver indeholdende 2,5 ml emulsion (10 x 0,25 ml 
- two packs of 25 vials (type I glass) of 2.5 ml emulsion (10 x 0.25 ml doses) with a stopper (butyl rubber).
Lægen eller sygeplejersken vil give dig Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram som en indsprøjtning i overarmsmusklen. 
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.
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. 
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.
Det anbefales at den anden vaccination bliver givet mindst tre uger efter den første vaccination. 
The second dose should be given after an interval of at least three weeks.
Immunrespons mod A/Vietnam/1194/2004: 
Immune response againstA/Vietnam/1194/2004 :
Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram er en vaccine, som anvendes til voksne i alderen fra 18. 
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is a vaccine for use in adults from 18 years old.
Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram bør anvendes i overensstemmelse med officielle retningslinjer. 
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should be used in accordance with official guidance.
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. 
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.
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. 
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.
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. 
Tell the doctor requesting these tests that you have recently received Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals
25 hætteglas: emulsion 
Emulsion for emulsion for injection 25 vials: emulsion
KG Zirkustraße 40, D-01069 Dresden Tyskland 
GlaxoSmithKline Biologicals Branch of SmithKline Beecham Pharma GmbH & Co. KG Zirkustraße 40, D-01069 Dresden Germany
4.4 og 5.1. 
For further information, see sections 4.4 and 5.1.
Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram må under ingen omstændigheder gives intravaskulært eller intradermalt. 
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should under no circumstances be administered intravascularly or intradermally.
Du må ikke få Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram hvis noget af ovennævnte passer på dig. 
Do not have Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg if any of the above apply to you.
Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger. 
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.
Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her. 
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram bør derfor ikke gives samtidig med andre vacciner. 
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.
De potentielle fordele for moderen og risikoen for barnet skal overvejes før administration af Prepandemisk influenzavaccine GlaxoSmithKline i ammeperioden. 
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.
Ikke almindelig: Generaliserede hudreaktioner inkl. 
Uncommon: Generalised skin reactions including urticaria
Der findes ingen oplysninger om brugen af Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram til gravide eller ammende kvinder. 
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.
Der findes ingen data fra overvågning efter markedsføring for Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram . 
No post-marketing surveillance data are available following Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg administration.
Et fuldstændigt vaccinationsprogram med Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline 3,75 μg består af to doser. 
A complete vaccination course with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg consists of two doses.
Du vil få to vaccinationer af Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram. 
You will receive two doses of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Indsendelse af PSUR når Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram administreres under en influenzapandemi: 
PSUR submission when Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is used during the influenza pandemic:
* hæmagglutinin 
* haemagglutinin
Disse bivirkninger kan også opstå efter anvendelse af Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram. 
These side effects may occur with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Boosterserokonverteringsrate2 
Booster seroconversion rate2
En pakke Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram består af: 
One pack of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg consists of:
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. 
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.
Hvis den rekonstituerede vaccine ser anderledes ud, bør den kasseres. 
In the event of other variation being observed, discard the vaccine.
Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram suspension og emulsion til injektionsvæske, emulsion. 
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension and emulsion for emulsion for injection.
Før injektion skal de to væsker sammenblandes. 
If a double dose is given, the injections should be given into opposite limbs.
Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram består af to hætteglas: 
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg consists of two containers:
• Søvnighed 
• Sleeplessness
Vær ekstra forsigtig med at anvende Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram: 
Take special care with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg:
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 
Against A/Indonesia 21 days after boosting with A/Indonesia
Der findes ingen oplysninger om samtidig brug af Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram og andre vacciner. 
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.
- Lægen har ordineret Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, 
How to store Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram indeholder 
What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg contains
• Overfølsomhedsreaktioner, der kan føre til alvorligt blodtryksfald, og som, hvis de ikke behandles, kan føre til kollaps, bevidstløshed og dødsfald. 
• Low blood platelet count which can result in bleeding or bruising
Efter rekonstitution indeholder 1 dosis (0,5 ml): Split influenzavirus, inaktiveret, indeholdende antigen svarende til: 
Split influenza virus inactivated, containing antigen* equivalent to:
Efter rekonstitution svarer indeholdet af Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram (5 ml) til 10 vaccinedoser. 
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.
Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram - udseende og pakningsstørrelse 
What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg looks like and contents of the pack
Biologicals 3,75 mikrogram suspension og emulsion til injektionsvæske, emulsion Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) 
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)
Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram suspension til injektionsvæske, emulsion. 
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension for emulsion for injection IM
Emulsion til Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram injektionsvæske, emulsion 
Emulsion for emulsion for injection for Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg
KG 
Norge
Nedennævnte bivirkninger er set i kliniske forsøg med vaccination med Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram. 
The side effects listed below have occurred with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg in clinical studies:
Det skal du vide om Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram 
How to store Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg
Det må du kun gøre én gang. 
Only do this once.
Vent 5-15 minutter 
Wait 5 to 15 minutes;
Det er, fordi der er begrænset information om denne gruppe. 
This is because there is limited information in this group of people.
Bemærk: Der var nogle forskelle i analysemetoder på tværs af de 3 studier. 
Note: There were some differences in analysis methods across the 3 studies.
Dato for første markedsføringstilladelse: 13. april 2012 Dato for seneste fornyelse: 11. januar 2017 
Date of first authorisation: 13 April 2012 Date of latest renewal: 11 January 2017
Patienterne skal rådes til at læse dem grundigt igennem. 
Patients should be advised to carefully read them.
Der foreligger ikke tilstrækkelige data for denne population til at støtte en anbefaling for eller imod dosisjustering. 
There are insufficient data in this population to support a recommendation for or against dose adjustment.
Du bør undgå at bruge dette lægemiddel, hvis du er gravid. 
You should avoid using this medicine if you are pregnant.
Absolut ml 
Absolute mL
- Forværring af symptomer. 
- Worsening of symptoms.
- Brug en ny inhalator hver uge. 
- Use a new inhaler each week.
Der foreligger ingen data for børn under 12 år. 
There are no data available for children under 12 years of age.
Relativ forventet % 
Absolute % predicted Relative % predicted
Dornase alfa (hvis relevant) 5. 
Dornase alfa (if applicable) 5.
Denne virkning blev ikke bemærket hos andre arter og resulterede ikke i kliniske tegn. 
This effect was not noted in any other species and did not result in clinical signs.
Den første dosis tages i 4 trin: 
The first dose is taken in 4 steps:
Lægen vil fortælle dig, hvor længe du skal bruge medicinen. 
Your doctor will tell you how long to use this medicine for.
Hyppighederne er defineret således: 
Frequencies are defined as:
Der er også links til websites om sjældne sygdomme og om, hvordan de behandles. 
There are also links to other websites about rare diseases and treatments.
Det er almindeligt og rammer op til 1 ud af 10 
This happens commonly, which may affect up to 1 in 10 people.
- Du skal tage aftendosen mindst 2-3 timer, før du går i seng. 
- Have the evening dose at least 2 to 3 hours before you go to bed.
For patienter, som får flere respirationsbehandlinger, er den anbefalede rækkefølge: 
For patients receiving several respiratory therapies, the recommended order is:
Voksne på 18 år og derover 
Adults 18 years of age and over
• akut blødning ≥240 ml inden for 24 timer 
• acute bleeding ≥240 ml in a 24-hour period
- Pust ud, og træk vejret normalt igen. 
- Breathe out, and then breathe normally again.
Der er ikke udført formelle interaktions studie. 
No formal interaction studies have been conducted.
Den foreslåede rækkefølge er som følger, medmindre lægen har sagt noget andet: 
The suggested order is as follows, unless otherwise advised by your doctor:
Du må ikke holde op med at bruge Bronchitol uden at tale med lægen først, også selvom du har det bedre. 
Do not stop using your Bronchitol without talking to your doctor first, even if you feel better.
Ansøgeren bedes indsende periodiske analyser af CF-studie hver 6. måned i 3 år og derefter en gang om året i 2 år. 
The applicant is requested to submit periodic analysis of the CF study every 6 months for 3 years and annually for 2 years.
Tal med lægen, hvis hosten ikke forsvinder, eller den bekymrer dig. 
Talk to your doctor if the cough won't go away or worries you.
Gentag trin 3-10 for hver kapsel - Udfør disse trin for hver af de 10 kapsler. 
Repeat steps 3 to 10 for each capsule - Perform these steps for each of the ten capsules.
Gentag inhalationen for at få din dosis. 
Repeat the inhalation to get your dose.
Det er derfor ikke muligt at udelukke en risiko for nyfødte/spædbørn. 
A risk to the newborns/infants cannot be excluded.
Hvis det ikke sker, sidder kapslen måske fast. 
If this does not happen, the capsule may be stuck.
o Behovet for at monitorere behandlingen, og hvornår behandling skal seponeres. 
o The need for monitoring and when to withhold treatment.
Fysioterapi/motion 4. 
Physiotherapy/exercise 4.
Aluminium/polyamid/PVC/aluminiumsblistere. 
Aluminium/polyamide/PVC/aluminium blisters.
Tmax efter inhaleret administration var 1,5 ± 0,5 timer. 
The Tmax after inhaled administration was 1.5 ± 0.5 hours.
Behandlingsdosis (2-ugers-pakninger) - Du skal bruge Bronchitol hver dag. 
Treatment dose (2-week packs) - You must use Bronchitol every day.
Yderligere 2,8 % (n=34) af patienterne fra de tre studie havde ufuldstændige MTT'er og blev ikke randomiseret. 
An additional 2.8% (n=34) of patients from the three studies had incomplete MTTs and were not randomised.
Læg kapslen i - Kontrollér først, at dine hænder er tørre. 
Put in the capsule - First make sure your hands are dry.
Produktiv hoste kan bidrage til clearance af sputum. 
Productive cough can contribute to sputum clearance.
Alle patienter skal overvåges, indtil deres FEV1 er vendt tilbage til baseline-niveauet. 
All patients should be monitored until their FEV1 has returned to baseline levels.
- Du hoster blod op eller har blod i spyttet. 
- Coughing up blood or blood in your sputum.
- Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis. 
- Do not use a double dose to make up for a forgotten dose.
Før lancering af lægemidlet i de enkelte medlemsstater skal indehaveren af markedsføringstilladelsen aftale indholdet af og formatet for undervisningsmaterialet med den nationale kompetente myndighed. 
Prior to launch of the medicinal product in each Member State, the Marketing Authorisation Holder shall agree the content and format of the educational material with the national competent authority.
Hvis du holder op med at bruge Bronchitol, kan symptomerne blive værre. 
If you stop using Bronchitol your symptoms may get worse.
Rækkefølge for brug af denne medicin 
Order of using this medicine
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 (≥1/100.000 til 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data). 
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (≥1/100,000 to <1/10,000); not known (cannot be estimated from the available data).
Kravene om fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs webportal. 
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Der foreligger begrænsede data vedrørende brug af mannitol til gravide kvinder. 
There are limited data from the use of mannitol in pregnant women.
Svær/alvorlig hæmoptyse er: 
A massive/serious haemoptysis is considered to be:
Middelterminalhalveringstiden hos voksne var omkring 4-5 timer i serum og omkring 3,66 timer i urin. 
The mean terminal half-life in adults was approximately 4 to 5 hours from serum and approximately 3.66 hours from urine.
Det er også med til at forbedre lungernes tilstand og din vejrtrækning. 
It also helps improve the condition of your lungs and your breathing.
Pakningen med 2 ugers behandling er til behandlingsbrug. 
The 2-week treatment pack is for treatment use.
Hvis du har glemt at bruge Bronchitol - Hvis du glemmer at tage en dosis af medicinen, skal du tage den, så snart du husker det, og fortsætte som normalt. 
If you forget to use Bronchitol - If you forget a dose, use it as soon as you remember it and carry on as usual.
Brug Bronchitol som en del af din normale daglige behandlingsrutine. 
Use Bronchitol as part of your normal daily treatment routine.
En lille procentdel af systemisk absorberet mannitol gennemgår metabolisering til glykogen og kuldioxid i leveren. 
A small percentage of systemically absorbed mannitol undergoes hepatic metabolism to glycogen and carbon dioxide.
Du må ikke forsøge at løsne kapslen ved at trykke på prikkeknapperne igen. 
Do not try to loosen the capsule by pressing the piercing buttons again.
Det er almindeligt. 
This happens commonly.