natgillin/translations-raw huggingface dataset:
Ikke almindelige (kan ramme op til 1 ud af 100 patienter) - Brænden eller smerter i tungen - CF-relateret sukkersyge - Smerter i bryst og mave - Forandret stemme - Koldsved - Tillukning - Dehydrering - Nedsat appetit - Diarré - Øresmerter - Træthed - Svimmelhed - Kvalme - Utilpashed - Influenza og feber - Luft i maven - Halsbrand - Broksmerter - Hyperventilation - Kløe, udslæt, akne - Stive led og ledsmerter - Sygelig tankegang - Sår i munden - Infektion i luftvejene - Løbende næse - Spytinfektion - Irritation i halsen - Problemer med at sove - Infektion med gærsvamp i munden (trøske) - Urininkontinens 
Uncommon (may affect up to 1 in 100 people) - Burning or painful sensation on the tongue - CF related diabetes - Chest and abdominal pain - Change in voice - Cold sweat - Congestion - Dehydration - Decreased appetite - Diarrhoea - Ear pain - Feeling tired - Feeling dizzy - Feeling sick (nausea) - Feeling unwell - Flu and fever - Wind - Heartburn - Hernia pain - Hyperventilation - Itching, rash, acne - Joint stiffness and pain - Morbid thoughts - Mouth ulcers - Respiratory tract infection - Runny nose - Sputum infection - Throat irritation - Trouble sleeping - Yeast infection of the mouth (thrush) - Unintentional loss of urine
- Du får det bedste resultat med Bronchitol, hvis du inhalerer kapslerne en for en. 
- To get the best results from Bronchitol, inhale each capsule one after another.
Hvis inhalatoren skal rengøres, skal det kontrolleres, at den er tom, hvorefter den skal vaskes i varmt vand. 
If the inhaler does require cleaning, it must be ensured that the device is empty, then it should be washed in warm water and before re-use,the inhaler should be allowed to thoroughly air dry.
Den endelige rapport forventes i første kvartal af 2018. 
The final report is expected in Q3
Den estimerede virkning af behandling (middelværdiændring og 95 % CI i forhold til baseline over 26 uger, mITT-population) på FVC var 108,78 ml (95 % CI: 49,21, 168,35) i studie 301, 71,4 ml (95 % CI: 10,57, 132,13) i studie 302 og 40 ml (95 % Cl: -12, 92) i studie 303. 
The estimated effect of treatment (mean change and 95% CI from baseline over 26 weeks, mITT population) on FVC was 108.78 ml (95% CI: 49.21, 168.35) in study 301 and 71.4 ml (95% CI: 10.57, 132.13) in study 302 and 40 ml (95% CI: -12, 92) in study 303.
Bronchitol inhaleres i lungerne for at hjælpe med cystisk fibrose, som er en arvelig sygdom, der påvirker de kirtler i lungerne, tarmen og bugspytkirtlen, som udskiller slim og fordøjelsessafter. 
Bronchitol is inhaled into the lungs to help with cystic fibrosis, an inherited disease that affects the glands in the lungs, gut and pancreas that secrete fluids such as mucus and digestive juices.
Pakningen med en initialdosis Bronchitol indeholder 1 blister med 10 kapsler og 1 inhalator. 
One initiation dose pack of Bronchitol contains 1 blister with 10 capsules and 1 inhaler.
27 (7,1 %) ud af 378 patienter, som gennemførte mannitoltolerancetesten (MTT) i studie 301, 18 (5,3 %) ud af 341 patienter i studie 302 og 25 (5,1 %) ud af 486 patienter i studie 303 havde en positiv MTT. 
Twenty seven (7.1%) out of 378 patients who undertook the mannitol tolerance test (MTT) in study 301, 18 (5.3%) out of 341 patientsin study 302 and 25 (5.1%) out of 486 patients in Study 303 had a positive (MTT).
Ikke almindelig Øget alkalisk fosfatase i blodet, positiv sputumtest for bakterier eller svampe 
Uncommon Blood alkaline phosphatase increased, Bacteria or fungus sputum test positive
En pakning med 2 ugers Bronchitol-behandling indeholder 28 blistere med 10 kapsler hver (280 kapsler i alt) og 2 inhalatorer. 
One 2-week treatment pack of Bronchitol contains 28 blisters with 10 capsules each (280 capsules in total) and 2 inhalers.
I undersøgelse 302 havde 15,2 % af forsøgspersonerne i mannitolarmen og 19 % i kontrolarmen en PDPE. 
In study 302 15.2% subjects in the mannitol arm and 19% in the control had a PDPE.
Yderligere oplysninger om, hvordan du passer din inhalator, kan du se sidst i brugsanvisningen. 
For more advice on how to look after your inhaler, please see the end of the instructions.
Virkning og sikkerhed er ikke klarlagt hos patienter med bronkiektasi, som ikke har CF. 
Efficacy and safety have not been established in non-CF bronchiectasis patients.
Det skal du vide, før du begynder at bruge Bronchitol 
What you need to know before you use Bronchitol
Bivirkninger, som kun opstod ved vurderingen af startdosen (MTT), er bronkospasmer, brystsmerter, odynofagi og kløgning. 
Adverse reactions that occurred only with initiation dose assessment (MTT) are bronchospasm, chest pain, odynophagia and retching
I undersøgelse 302 var den relative ændring (95 % CI) for rhDNase-brugere og ikke-brugere henholdsvis 3,21 (-0,61, 7,03) og 4,73 (-1,93, 11,40). 
In study 302 the relative change (95% CI) for rhDNase users and non-users was 3.21 (-0.61, 7.03) and 4.73 (-1.93, 11.40), respectively.
I studie 303 var den relative ændring (95 % CI) for rhDNase-brugere og ikke-brugere henholdsvis 1,30 (-0,91, 3,51) og 4,45 (0,52, 8,38). 
In study 303 the relative change (95% CI) for rhDNase users and non-users was 1.30 (-0.91, 3.51) and 4.45 (0.52, 8.38), respectively.
Sikkerhed og virkning af Bronchitol hos børn og unge i alderen 6-18 år er endnu ikke klarlagt. 
The safety and efficacy of Bronchitol in children and adolescents aged 6 to 18 years has not yet been established.
Ikke almindelig Pyreksi 
Uncommon Pyrexia
I ITT-populationen i en ublindet dosisrespons studie, DPM-CF-202, var middelværdien (SD) for den procentvise ændring i FEV1 for dosen på 400 mg 8,75 (SD: 12,4) og -1,569 (SD: 9,0) for dosen på 40 mg (p < 0,0001). 
In the ITT population of an open label dose response study, DPM-CF-202, the mean (SD) percent change in FEV1 for the 400 mg dose was 8.75 (SD: 12.4) and -1.569 (SD: 9.0) for 40 mg dose (p <
Bronkodilator 
Bronchodilator
27 (7,1 %) ud af 378 patienter, som gennemførte mannitoltolerancetesten (MTT) i studie301, 18 (5,3 %) ud af 341 patienter i studie 302 og 25 ud af 486 patienter (5,1 %) i studie 303 havde en positiv MTT defineret som enten 1) et fald i FEV1 >20 % i forhold til baseline ved midtpunktet (trin 4) eller 2) et fald i forhold til baseline ved testens afslutning på > 20 %, som ikke bedredes til < 20 % inden for 15 minutter, eller 3) som havde et fald i FEV1 > 50 % i forhold til baseline ved testens afslutning (trin 6), eller 4), som havde et fald i Sp02 til < 89 % under proceduren. 
Twenty seven (7.1%) out of 378 patients who undertook the mannitol tolerance test (MTT) in study 301, 18 (5.3) out of 341 patients in study 302 and 25 out of 486 patients (5.1%) in study 303 had a positive MTT defined as either 1) a fall in FEV1 >20% from baseline at midpoint (step 4) or 2) fall from baseline > 20 % at end of test that did not recover to < 20% within 15 minutes or 3) who had a fall in FEV1 > 50% from baseline at end of test (step 6) or 4) who had a fall in Sp02 to < 89% during the procedure.
Sikkerhed og virkning af Bronchitol hos børn under 6 år er endnu ikke klarlagt. 
The safety and efficacy of Bronchitol in children aged less than 6 years has not been established.
- Skil aldrig inhalatoren ad. - Læg aldrig en kapsel direkte i inhalatorens mundstykke. 
- Never place a capsule directly into the mouth-piece of your inhaler.
Bronkial hyperreaktivitet over for inhaleret mannitol (se pkt. 
Bronchial hyperresponsiveness to inhaled mannitol (see section 4.4).
En kapsel indeholder 40 mg mannitol. 
Each capsule contains 40 milligrams mannitol.
Brug Bronchitol før fysioterapi, hvis det er en del af din normale daglige behandlingsrutine Dornase alfa (Pulmozyme), hvis det er en del af din behandlingsrutine Inhalationsantibiotika, hvis det er en del af din behandlingsrutine 
Dornase alfa (Pulmozyme) if this is part of your treatment routine Inhaled antibiotics if this is part of your treatment routine
Ikke almindelig Svimmelhed 
Uncommon Dizziness
Bivirkninger, der kun forekom ved vurderingen af startdosen (MTT), er dehydrering, fald i forceret eksspiratorisk volumen, hypoksi, diarré, smerter i øvre abdomen, aftøs stomatitis, odynofagi, brystsmerter og stigning i alkaliskfosfatase i blodet. 
Adverse reactions that occurred only with the initiation dose assessment (MTT) are dehydration, forced expiratory volume decreased, hypoxia, diarrhoea, abdominal pain upper, aphthous stomatitis, odynophagia, chest pain and blood alkaline phosphatase increased.
- Inhaler kapslens indhold ved hjælp af inhalatoren med en til to indåndinger. 
- Inhale the contents of the capsule using the inhaler, with one or two breaths in.
I studie 301 var de totalt set hyppigst rapporterede bivirkninger under MTT hoste hos 20 (5,3 %) forsøgspersoner, hvæsende vejrtrækning/bronkospasme hos syv (1,9 %) forsøgspersoner og ubehag i brystet hos seks (1,6 %) forsøgspersoner. 
In study 301, overall the most frequently reported adverse reactions during the MTT were cough in 20 (5.3%) subjects, wheezing/bronchospasm in seven (1.9%) subjects and chest discomfort in six (1.6%) subjects.
Nærmere oplysninger om anvendelsen af inhalatoren kan findes i indlægssedlen. 
Detailed instructions on how to use the inhaler can be found in the patient information leaflet.
Hos unge (12-17 år) blev den relative ændring i % forventet FEV1 sammenlignet med kontrolgruppen forbedret med henholdsvis 3,31 % (95 % CI -2,29, 8,90, N=55) og 0,42 % (95 % CI -5,45, 6,29, N=94) over 26 uger (p=0,245 og 0,888). 
In adolescents (12-17 years) relative change in % predicted FEV1 compared to control improved by 3.31% (95% CI -2.29, 8.90, N=55) and 0.42% (95% CI -5.45, 6.29, N=94) over 26 weeks (p=0.245 and 0.888) respectively.
Lav et hul i kapslen - Det frigiver pulveret i kapslen, når du trækker vejret ind. I denne indlægsseddel kalder vi det at 'prikke'. 
Make a hole in the capsule - This lets the powder in the capsule be released when you breathe in.
Den forventede middelværdi (SD) for baseline-FEV1-procent i studie DPM-CF-301 (sikkerhedspopulation, N= 295) var 62,4 (SD:16,45) og 61,4 (SD:16,13) i henholdsvis mannitol- og kontrolgruppen. 
Mean (SD) baseline FEV1 percent predicted in study DPM-CF-301 (safety population, N= 295) was 62.4 (SD:16.45) and 61.4 (SD:16.13) in the mannitol and control groups, respectively.
I studie DPM-CF-301 og 302 blev den relative % forventet FEV1 sammenlignet med kontrolgruppen hos børn (6-11 år) forbedret med henholdsvis 0,44 % (95 % CI -5,90, 6,77, N=43) og 6,1 % (95 % CI -1,28, 13,54, N=59) over 26 uger (p=0,892 og 0,104). 
In studies DPM-CF-301 and 302 relative % predicted FEV1 compared to control in children (6-11 years) was improved by 0.44% (95% CI -5.90, 6.77, N=43) and 6.1% (95% CI -1.28, 13.54, N=59) over 26 weeks (p=0.892 and 0.104) respectively.
Advarsler og forsigtighedsregler Tal meddin læge eller apotekspersonalet, før du bruger Bronchitol: - hvis du har astma 
Talk to your doctor or pharmacist before using this medicine: - if you have asthma;
Den hyppigst observerede bivirkning i forbindelse med anvendelse af Bronchitol under vurdering af initialdosis hos den pædiatriske population er hoste (4,8 % af patienterne). 
The most commonly observed adverse reaction associated with the use of Bronchitol during the initiation dose assessment with the paediatric population is cough (4.8% of patients).
Den hyppigst observerede bivirkning i forbindelse med anvendelse af Bronchitol under vurdering af initialdosis er hoste (2,9 % af patienterne) (se pkt. 
The most commonly observed adverse reaction associated with the use of Bronchitol during the initiation dose assessment is cough (2.9% of patients), (see section 4.4).
Bronchitol-kapsler kan kun bruges med den inhalator, som medfølger i pakningen. 
Bronchitol capsules can only be used with the inhaler provided in the pack.
Nedsat nyre- eller leverfunktion 
Impaired lung function
Luk inhalatoren - Hold inhalatoren lodret. 
Close the inhaler - Keep the inhaler in an upright position.
Den vigtigste bivirkning i forbindelse med anvendelse af Bronchitol under vurdering af initialdosis hos den pædiatriske population er bronkospasme. 
The most important adverse reaction associated with the use of Bronchitol during the initiation dose assessment with the paediatric population is bronchospasm.
Hæmoptyse er en almindelig bivirkning, som er rapporteret i de kliniske studie af Bronchitol. 
Haemoptysis has been commonly reported with Bronchitol in clinical studies.
Den hyppigst observerede bivirkning i forbindelse med anvendelse af Bronchitol er hoste. 
The most commonly observed adverse reaction associated with the use of Bronchitol is cough.
- Pulveret i kapslerne må kun inhaleres med den inhalator, som medfølger i pakningen. 
- The powder in the capsules must only be inhaled using the inhaler included in the pack.
Før behandling med Bronchitol indledes, skal alle patienter vurderes med henblik på bronkial hyperreaktivitet over for inhaleret mannitol under administration af initialdosen (se pkt. 
Before commencing treatment with Bronchitol all patients should be assessed for bronchial hyperresponsiveness to inhaled mannitol during administration of their initiation dose (see sections 4.4 and 5.1).
2-ugers-æsken indeholder 28 blistere (med 10 kapsler hver) og to inhalatorer. 
The 2-week carton contains 28 blisters (of 10 capsules each) and two inhaler devices.
Æsken med initialdosis indeholder 1 blister (med 10 kapsler) og en inhalator. 
The initiation dose carton contains 1 blister (of 10 capsules) and one inhaler device.
Farmakoterapeutisk klassifikation: Midler mod hoste og forkølelse, mucolytika ATC-kode: R05CB16 
Pharmacotherapeutic group: Cough and cold preparations, Mucolytic.
Der foreligger ingen kliniske data for virkningen af mannitol på human fertilitet. 
For mannitol no clinical data on fertility is available.
Brug din bronkieudvidende medicin 
Use your bronchodilator;
Pulveret inhaleres i lungerne med den inhalator, som medfølger i pakningen. 
The powder is inhaled into the lungs using the inhaler provided in the pack.
En patient defineres som hyperreaktiv overfor inhaleret mannitol og må ikke blive ordineret den terapeutiske dosisplan, hvis de oplever noget af det følgende under den indledende vurdering af dosis: - ≥10 % fald i SpO2 i forhold til baseline på noget tidspunkt i vurderingen - Fald i FEV1 er ≥20 % i forhold til baseline ved 240 mg kumulativ dosis - FEV1 er faldet med 20-<50 % (i forhold til baseline) ved vurderingens afslutning og vender ikke tilbage til <20 % inden for 15 minutter - FEV1 er faldet med ≥50 % (i forhold til baseline) ved vurderingens afslutning 
- ≥10% fall from baseline in SpO2 at any point of the assessment; - FEV1 fall from baseline is ≥20% at 240 mg cumulative dose; - FEV1 has fallen 20-<50% (from baseline) at the end of the assessment and does not return to
Kapslerne indføres særskilt i inhalatoren. 
Each of the capsules is loaded into the device separately.
Den vigtigste bivirkning i forbindelse med anvendelse af Bronchitol er hæmoptyse. 
The most important adverse reaction associated with the use of Bronchitol is haemoptysis.
Der er ikke udført karcinogenicitets studie med mannitol til inhalation. 
Carcinogenicity studies have not been carried out with inhaled mannitol.
Hos rhDNase-brugerne i studie 301 var den relative ændring i forventet FEV1 % i forhold til baseline over 26 ugers behandling 2,83 (95 % CI -0,62, 6,27). 
The treatment effect of Bronchitol on FEV1 was less evident in the subgroup of patients who were receiving concomitant rhDNase.In rhDNase users in study 301 the relative change in FEV1 % predicted from baseline across 26 weeks of treatment was 2.83 (95% CI -0.62, 6.27).
Der er ikke udført reproduktions- og udviklingstoksicitets studie med mannitol til inhalation. 
Reproduction and developmental toxicity studies have not been carried out with inhaled mannitol.
Bronchitol er til inhalation med den inhalator, som medfølger i pakningen. 
Bronchitol is for inhalation use, using the inhaler provided in the pack.
Hyperreaktive patienter bør ikke ordineres den terapeutiske dosisplan med Bronchitol (se afsnit 4.3). 
Hyperresponsive patients should not be prescribed the therapeutic dose regimen of Bronchitol (see section 4.3).The usual precautions regarding bronchial hyperresponsiveness monitoring apply (see section 4.2).
Inhalator 
Inhaler device
Kapslerne må først tages ud af blisterpakningen umiddelbart før brug. 
Do not remove capsules from blister until immediately before use.
Den vigtigste bivirkning i forbindelse med anvendelse af Bronchitol under vurdering af initialdosis er bronkospasme (se pkt. 
The most important adverse reaction associated with the use of Bronchitol during the initiation dose assessment is bronchospasm (see section 4.4).
Sådan skal du bruge Bronchitol 
How to use Bronchitol
I tvivlstilfælde gentages vurderingen af initialdosis som beskrevet i pkt. 
The initiation dose assessment described in section 4.2 should be repeated if uncertainty exists.
Brug den anden inhalator, mens den tørrer. 
While it is drying, use your other inhaler.
Pædiatrisk population Sikkerhed og virkning af Bronchitol hos børn og unge under 18 år endnu ikke klarlagt (se pkt. 
The safety and efficacy of Bronchitol in children and adolescents aged less than 18 years has not been established (see section 4.2).
Bronchitol 40 mg inhalationspulver, hårde kapsler 
Bronchitol 40 mg inhalation powder, hard capsules
Hoste var en almindelig bivirkning, som blev rapporteret i de kliniske studie af Bronchitol (se pkt. 
Cough was commonly reported with use of Bronchitol in clinical studies (see section 4.8).
Ikke almindelig Produktiv hoste, irritation i halsen, astma, bronkospasme, fald i forceret eksspiratorisk volumen, rinoré, dyspnø, dysfoni, hyperventilation, obstruktion af luftvejene, 
Oropharyngeal pain, Wheezing Uncommon Productive cough, Throat irritation, Asthma, Bronchospasm, Forced expiratory volume decreased, Rhinorrhoea, Dyspnoea Dysphonia, Hyperventilation, Obstructive airways disorder, Respiratory tract congestion, Sputum discoloured, Hypoxia
Den hyppigst observerede bivirkning i forbindelse med anvendelse af Bronchitol er hoste (se pkt. 
The most commonly observed adverse reaction associated with the use of Bronchitol is cough (see section 4.4).
Tag hætten af - Hold inhalatoren lodret med begge hænder, og tag hætten af. 
Take off the cap - Using both hands, hold the inhaler upright and take off the cap.
Patienter skal overvåges for bronkial hyperreaktivitet overfor inhaleret mannitol under deres indledende vurdering af dosis før de påbegynder den terapeutiske dosisplan med Bronchitol. 
Patients must be monitored for bronchial hyperresponsiveness to inhaled mannitol during their initiation dose assessment before commencing the therapeutic dose regimen of Bronchitol.If the patient is unable to perform spirometry or complete the initiation dose assessment, they must not be prescribed Bronchitol.
Kapslernes indhold inhaleres via inhalatoren to gange dagligt med en til to inhalationer. 
The contents of the capsules are inhaled via the inhaler device with one or two breaths.
Læs indlægssedlen for oplysninger om anvendelse af inhalator. 
Refer to package leaflet for inhaler device instructions.
Bronchitol 40 mg, inhalationspulver, hårde kapsler mannitol 
Bronchitol 40 mg, inhalation powder, hard capsules mannitol
Bronchitol 40 mg, inhalationspulver, hårde kapsler Mannitol 
Bronchitol 40 mg, inhalation powder, hard capsules Mannitol
Ikke almindelig Pyreksi, træthed, influenzalignende sygdom, broksmerter, utilpashed, brystsmerter 
Condition aggravated, Chest discomfort Uncommon Pyrexia, Fatigue, Influenza like illness, Hernia pain, Malaise, Chest pain
Der indgik kun voksne patienter i studie DPM-CF303. 
Study DPM-CF-303 was all adult patients.
Brug af anden medicin sammen med Bronchitol Fortæl altid lægen eller på apoteket, hvis du bruger anden medicin eller har gjort det for nylig. 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Posttussiv opkastning, opkastning Ikke almindelig Kvalme, diarré, opstød, flatulens, gastroøsofageal reflukssygdom, glossodyni, kløgning, stomatitis, smerter i øvre abdomen, aftøs stomatitis, odynofagi Hud og subkutane væv Ikke almindelig Akne, koldsved, pruritus, udslæt, kløende udslæt Knogler, led, muskler og bindevæv 
Post-tussive vomiting, Vomiting Uncommon Nausea, Diarrhoea, Eructation, Flatulence, Gastrooesophageal reflux disease, Glossodynia, Retching, Stomatitis, Abdominal pain upper, Aphthous Stomatitis, Odynophagia
I studie DPM-CF-303 (N=423) var den forventede baseline FEV1-procent 63,17 (SD: 15,15) og 62,98 (SD: 13,65). 
In study DPM-CF-303 (N=423) the baseline FEV1 percent predicted was 63.17 (SD: 15.15) and 62.98 (SD: 13.65).In study DPM-CF-301 64.4 % of the patient population were adults while in study DPM-CF302 this figure was 49.5%.
Der er ikke udført reproduktionsStudie med mannitol til inhalation. 
Animal reproduction studies have not been carried out with inhaled mannitol.
Det skal du vide, før du begynder at bruge Bronchitol Sådan skal du bruge Bronchitol Bivirkninger 
What Bronchitol is and what it is used for What you need to know before you use Bronchitol How to use Bronchitol
Ikke almindelig Bærer af bakteriel sygdom, bronkitis, bronkopneumoni, lungeinfektion, oral candidiasis, faryngitis, stafylokokinfektion, infektion i øvre luftveje Metabolisme og ernæring Ikke almindelig Nedsat appetit, CF-relateret diabetes, dehydrering Psykiske forstyrrelser 
Infections and infestations Uncommon Bacterial disease carrier, Bronchitis, Bronchopneumonia, Lung infection, Oral candidiasis, Pharyngitis, Staphylococcal infection, Upper respiratory tract infection
Almindelig Hoste, tilstand forværret, hæmoptyse, orofaryngeale smerter, brystubehag, hvæsende vejrtrækning, astma, produktiv hoste Ikke almindelig Bronkitis, bronkopneumoni, dysfoni, hyperventilation, misfarvet sputum, irritation i halsen, faryngitis, infektion i øvre luftveje, bronkospasme, dyspnø, brystsmerter 
Uncommon Bronchitis, Bronchopneumonia, Dysphonia, Hyperventilation, Sputum Discoloured, Throat irritation, Pharyngitis, Upper respiratory tract infection, Bronchospasm, Dyspnoea, Chest pain
Luftveje, thorax og mediastinum 
Cough, Haemoptysis,
Hvis du har brugt for meget Bronchitol 
If you use more Bronchitol than you should
Læs den medfølgende indlægsseddel for oplysninger om anvendelse af inhalator. 
Refer to enclosed leaflet for inhaler device instructions.
Trin 6: Patientens FEV1 måles 15 minutter efter initialdosis 
Step 5: Patient inhales 160 mg (4x40 mg capsules), FEV1 is measured and SpO2 is monitored Step 6: Patients FEV1 is measured 15 minutes post initiation dose.
Almindelig Hovedpine Ikke almindelig Svimmelhed 
Renal or hepatic impairment
Fortsæt øjeblikkeligt til næste trin. 
Proceed immediately to next step.
Må under ingen omstændigheder fryses igen. 
Do not re-freeze under any circumstances.
Anvend sædvanlige aseptiske forholdsregler ved alle administrationsprocedurer. 
Apply the usual aseptic precautions to all administration procedures.
Den bør anvendes umiddelbart efter tilberedningen (al den opløste vaccine skal bruges inden for en time). 
It should be used immediately after the preparation (all of the diluted vaccine should be used up within one hour).
Gentag denne oprensningsproces en eller to gange. 
Repeat the rinsing operation once or twice.
ATCvet kode QI01AD15 
ATCvet code QI01AD15
En enkelt vaccination er tilstrækkelig til at yde beskyttelse i hele risikoperioden. 
A single vaccination is sufficient to provide protection during the risk period.
Apparatet skal være godkendt til sikkert og effektivt at give den korrekte dosis. 
The device should be proven to safely and effectively deliver the appropriate dose.
Dato for første markedsføringstilladelse: 09/08/2002 Dato for seneste fornyelse: 06/07/2012 
Date of first authorisation: 09/08/2002 Date of last renewal: 06/07/2012
Skal anvendes umiddelbart efter tilberedning. 
Use immediately after preparation.