FrancophonIA/ELRC3.0 huggingface dataset:
English: - EOX: epirubicin (50 mg/m as a bolus on day 1 every 3 weeks), oxaliplatin (130 mg/m given as a 2 hour infusion on day 1 every three weeks), and capecitabine (625 mg/m2 twice daily continuously).
Danish: - EOX: epirubicin (50 mg/ m2 som bolus på dag 1 hver 3. uge), oxaliplatin (130 mg/m2 som en to-timers infusion på dag 1 hver 3. uge) og capecitabin (625 mg/m2 to gange dagligt givet kontinuerligt).
English: 5-Fluorouracil 400 mg/m intravenous bolus, followed by
Danish: 400 mg/m2 intravenøs bolus, efterfulgt af 600 mg/ m2 intravenøs 22 timer
English: During pregnancy and lactation,
Danish: Graviditet og amning
English: Xeloda 500 mg film-coated tablets Pack size of 120 film-coated tablets (12 blisters of 10 tablets)
Danish: Xeloda 150 mg filmovertrukne tabletter Pakningsstørrelse60 filmovertrukne tabletter (6 blistre á 10 tabletter) Xeloda 500 mg filmovertrukne tabletter Pakningsstørrelse 120 filmovertrukne tabletter (12 blistre á 10 tabletter) 6.6 Regler for bortskaffelse og anden håndtering Procedurer for sikker håndtering af cytotoksiske lægemidler skal følges.
English: - ECF: epirubicin (50 mg/ m2 as a bolus on day 1 every 3 weeks), cisplatin (60 mg/m2 as a two hour infusion on day 1 every 3 weeks) and 5-FU (200 mg/m2 daily given by continuous infusion via a central line).
Danish: - ECF: epirubicin (50 mg/ m2 som bolus på dag 1 hver 3. uge), cisplatin (60 mg/m2 som en totimers infusion på dag 1 hver 3. uge) og 5-FU (200 mg/m2 dagligt givet som kontinuerlig infusion via et centralt venekateter).
English: 53% to 60% of all-grades HFS was observed in capecitabine monotherapy trials (comprising studies in adjuvant therapy in colon cancer, treatment of metastatic colorectal cancer, and treatment of breast cancer) and a frequency of 63% was observed in the capecitabine/docetaxel arm for the treatment of metastatic breast cancer.
Danish: 4.4) For capecitabindosis på 1.250 mg/m2 to gange dagligt på dagene 1 til 14 hver 3. uge blev der observeret hånd- og fodsyndrom i alle grader med en hyppighed på 53 % til 60 % i cabecitabinmonoterapistudierne (bestående af studier i adjuverende behandling af kolonkræft, behandling af metastatisk kolorektalkræft og behandling af brystkræft).
English: Recommended posology (see section 5.1):
Danish: Anbefalet dosering (se pkt.
English: Blister, Skin ulcer, Rash, Urticaria, Photosensitivity reaction, Palmar erythema, Swelling face, Purpura, Radiation recall syndrome
Danish: Urticaria, Fotosensitivitetsreaktioner, Palmart erythem, Hævelse i ansigtet,
English: In patients with severe renal impairment (creatinine clearance below 30 ml/min), Recent or concomitant treatment with brivudine (see section 4.4 and 4.5 for drug-drug interaction),
Danish: 4.4) · Graviditet og amning, · Patienter med svær leukopeni, neutropeni eller trombocytopeni, · Patienter med svær leverinsufficiens, · Patienter med svær nyreinsufficiens (creatininclearance under 30 ml/min), · Nylig eller samtidig behandling med brivudin (se pkt.
English: Light peach film-coated tablet of biconvex, oblong shape with the marking ‘150' on the one side and ‘Xeloda' on the other side.
Danish: Lys ferskenfarvet filmovertrukken, bikonveks, aflang tablet med mærkningen ”150” på den ene side og ”Xeloda” på den anden side.
English: Pyrexia, Weakness, +Lethargy, Temperature intolerance
Danish: Svaghed, +Letargi,
English: Constipation, Dyspepsia
Danish: Træthed, Asteni
English: Peach film-coated tablet of biconvex, oblong shape with the marking ‘500' on the one side and ‘Xeloda' on the other side.
Danish: Ferskenfarvet filmovertrukken, bikonveks, aflang tablet med mærkningen ”500” på den ene side og ”Xeloda” på den anden side.
English: The film-coated tablets are peach tablets of biconvex, oblong shape with the marking ‘500' on the one side and ‘Xeloda' on the other side.
Danish: Xeloda 500 mg filmovertrukne tabletter er ferskenfarvede, bikonvekse, aflange tabletter med mærkningen ”500” på den ene side og ”Xeloda” på den anden side.
English: The film-coated tablets are light peach tablets of biconvex, oblong shape with the marking ‘150' on the one side and ‘Xeloda' on the other side
Danish: Xeloda 150 mg filmovertrukne tabletter er lys ferskenfarvede, bikonvekse, aflange tabletter med mærkningen ”150” på den ene side og ”Xeloda” på den anden side.
English: Hyperglycaemia
Danish: Phenytoin
English: • bowel obstruction, collection of fluid in the abdomen, inflammation of the small or large intestine, the stomach or the oesophagus, pain in the lower abdomen, abdominal discomfort, heartburn (reflux of food from the stomach), blood in the stool jaundice (yellowing of skin and eyes)
Danish: nerveskader (neuropati) og føleforstyrrelser, · sløret syn eller dobbeltsyn, · svimmelhed, øresmerter, · uregelmæssige hjerteslag (arytmi) og hjertebanken, brystsmerter og hjertetilfælde (blodprop), · blodprop i de dybe vener, højt eller lavt blodtryk, hedeture, kolde hænder og fødder, lilla mærker på huden · blodprop i lungerne, sammenklappede lunger, ophostning af blod, astma, stakåndethed ved anstrengelse, · forstoppelse, væskeansamling i maven, betændelse i tynd- og tyktarm, maven eller spiserøret,
English: Colon and colorectal cancer:
Danish: Kolon- og kolorektalkræft
English: Eye disorders
Danish: Øjensmerter,
English: Hypocalcaemia,
Danish: Hyperbilirubinæ mi,
English: Common side effects (may affect up to 1 in 10 people) include: decreases in the number of white blood cells or red blood cells (seen in tests) dehydration, weight loss sleeplessness (insomnia), depression
Danish: Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 personer): · betændelse i blodet, urinvejsinfektion, betændelse i huden, næse- og halsinfektioner, svamp
English: • headache, sleepiness, dizziness, abnormal sensation in the skin (numbness or tingling sensation), taste changes eye irritation, increased tears, eye redness (conjunctivitis) inflammation of the veins (thrombophlebitis), shortness of breath, nose bleeds, cough, runny nose cold sores or other herpes infections infections of the lungs or respiratory system (e.g. pneumonia or bronchitis)
Danish: blod i afføringen, · gulsot (gulfarvning af hud og øje) · sår og vabler på huden, solfølsom hud, rødme i håndfladerne, hævelse eller smerter i ansigtet · hævede og/eller stive led, knoglesmerter, muskelsvaghed eller -stivhed, · væskeansamling i nyrerne, øget vandladning om natten, inkontinens, blod i urinen, stigning i kreatinin i blodet (tegn på nedsat nyrefunktion), · unormal blødning fra skeden · hævelse, kulderystelser og stivhed
English: • if you know that you have a partial deficiency in the activity of the enzyme dihydropyrimidine dehydrogenase (DPD)
Danish: Kontakt lægen eller apotekspersonalet, før du tager Xeloda · hvis du ved, at du har delvis mangel på aktivitet af enzymet dihydropyrimidindehydrogenase
English: UAB “RoБългария Рош България ЕООД Тел: +359 2 818 44 44
Danish: Тел: +359 2 818 44 44
English: Renal and urinary disorder
Danish: Nyrer og urinveje
English: Hypotension, Hot flush, Peripheral coldness
Danish: Hypotension, Hedeture,
English: • tiredness
Danish: Neuralgi,
English: Not applicable
Danish: Oral anvendelse
English: Hiccups, Pharyngolaryngeal pain, Dysphonia
Danish: Hyperhidrose, Erytematøst udslæt, Urticaria,
English: Flushing, Hypotension, Hypertensive crisis, Hot flush, Phlebitis
Danish: Ansigtsrødme, Hypotension, Hypertensiv krise, Hedetur,
English: Xeloda 500 mg film-caoted tablets
Danish: Xeloda 500 mg filmovertrukne tabletter
English: Hepatobiliary disorders
Danish: Oftalmologiske komplikationer
English: Xeloda 150 mg film-coated tablets Each film-coated tablet contains 150 mg capecitabine.
Danish: Det aktive stof er capecitabin Xeloda 150 mg filmovertrukne tabletter Hver tablet indeholder150 mg capecitabine
English: Posology
Danish: Encephalopati
English: Do this only once.
Danish: Gør det kun en enkelt gang.
English: • Repeat steps 8, 9, 10 and 11.
Danish: • Gentag trin 8, 9, 10 og 11.
English: Date of first authorisation: 30 November 2009 Date of latest renewal: 18 September 2014
Danish: Dato for første markedsføringstilladelse: 30. november 2009 Dato for seneste fornyelse: 18. september 2014
English: If this happens:
Danish: Hvis dette sker:
English: If this happens, you may be able to feel these pieces on your tongue.
Danish: Hvis dette sker, kan du muligvis mærke de små stykker på tungen.
English: Tell your doctor immediately
Danish: Kontakt øjeblikkeligt din læge:
English: This ensures that there is always enough medicine in your body to help you breathe more easily throughout the day and night.
Danish: Dette sikrer, at der altid er tilstrækkeligt med medicin i din krop til at hjælpe dig med at trække vejret nemmere i løbet af dagen og natten.
English: Steady state was achieved within 12 to 14 days.
Danish: Steady-state blev opnået inden for 12 til 14 dage.
English: • Hold your breath for at least 5-10 seconds or as long as you comfortably can while taking the inhaler out of your mouth.
Danish: • Hold vejret i mindst 5-10 sekunder eller så længe det er behageligt for dig, mens du tager inhalatoren ud af munden.
English: if you have heart problems.
Danish: hvis du har hjerteproblemer.
English: Approximately 41% of patients had severe COPD.
Danish: Ca. 41 % af patienterne havde svær KOL.
English: if you have epilepsy.
Danish: hvis du har epilepsi.
English: Other side effects may include:
Danish: Andre bivirkninger omfatter:
English: • Inhale the medicine again by repeating steps 8 and 9.
Danish: • Inhaler medicinen igen ved at gentage trin 8 og 9.
English: Hold breath:
Danish: Hold vejret:
English: These were reported voluntarily from a population of uncertain size, and it is therefore not always possible to reliably estimate the frequency or establish a causal relationship to exposure to the medicinal product.
Danish: De blev indberettet frivilligt fra en population af ukendt størrelse, og det er derfor ikke altid muligt på pålidelig vis at estimere frekvensen eller fastslå en årsagssammenhæng til eksponering for lægemidlet.
English: Treatment Dose (microgram)
Danish: Behandlings-dosis (mikrogram)
English: These were in the vast majority mild or moderate and became less frequent if treatment was continued.
Danish: Disse var overvejende lette eller moderate og blev mindre hyppige ved fortsat behandling.
English: Table 2 Symptom relief at 6 months treatment duration
Danish: Tabel 2 Symptomlindring efter 6 måneders behandlingsvarighed
English: A decreased pregnancy rate has been observed in rats.
Danish: Der er observeret en nedsat graviditetsrate i rotter.
English: Most people are able to empty the capsule with one or two inhalations.
Danish: De fleste kan tømme kapslen ved en eller to inhalationer.
English: Patients who do not experience improvement in breathing should be asked if they are swallowing the medicine rather than inhaling it.
Danish: Patienter, der ikke oplever en forbedring i vejrtrækningen, skal spørges, om de synker medicinen i stedet for at inhalere den.
English: • cold-like symptoms.
Danish: • forkølelseslignende symptomer.
English: • Breathe in rapidly but steadily and as deeply as you can.
Danish: • Tag en hurtig, men rolig og så dyb indånding som muligt.
English: The dose should only be increased on medical advice.
Danish: Dosis bør kun øges efter medicinsk vurdering.
English: You will feel tired, very thirsty and hungry (without gaining weight) and will pass more urine than usual (common).
Danish: Du føler dig træt, meget tørstig og sulten (uden at tage på i vægt) og har hyppigere vandladning end normalt (almindelig bivirkning).
English: If you do, don't worry.
Danish: Hvis det sker, er der ikke grund til bekymring.
English: In case such effects occur, treatment may need to be discontinued.
Danish: Hvis sådanne virkninger forekommer, kan det muligvis være nødvendigt at seponere behandlingen.
English: Limited treatment experience is available in individuals of African descent.
Danish: Der er begrænset erfaring for individer af afrikansk oprindelse.
English: The maximum dose is 300 microgram once daily.
Danish: Den maksimale dosis er 300 mikrogram en gang dagligt.
English: The mean age of patients was 64 years, with 48% of patients aged 65 years or older, and the majority (80%) was Caucasian.
Danish: Patienternes gennemsnitsalder var 64 år, hvoraf 48 % af patienterne var 65 år eller ældre, og størstedelen (80 %) var af kaukasisk oprindelse.
English: These may be signs of a condition called bronchospasm.
Danish: Dette kan være tegn på en tilstand kaldet bronkospasmer.
English: Do not use more than your doctor tells you to use.
Danish: Tag ikke mere, end din læge har fortalt dig.
English: • if you get high levels of sugar in your blood (diabetes).
Danish: • hvis du får højt indhold af sukker i blodet (sukkersyge).
English: As long as the capsule is empty, you have received enough of your medicine.
Danish: Så længe kapslen er tom, har du fået en tilstrækkelig mængde af din medicin.
English: Mass balance was complete with ≥90% of the dose recovered in the excreta.
Danish: Massebalance var fuldstændig med ≥90 % af dosen genfundet i ekskretet.
English: b: indacaterol 150 and
Danish: b: indacaterol 150 og
English: Clean your inhaler once a week.
Danish: Rengør inhalatoren én gang om ugen.
English: If the capsule is empty, there is no need for concern.
Danish: Hvis kapslen er tom, er der ikke grund til bekymring.
English: The magnitude of response was generally greater than seen with active comparators (Table 2).
Danish: Størrelsen af responset var generelt større end responset for aktive produkter til sammenligning (tabel 2).
English: It will also help you to remember to use it.
Danish: Det hjælper dig også til at huske at tage medicinen.
English: Indacaterol was not embryotoxic or teratogenic in rats or rabbits.
Danish: Indacaterol var ikke embryotoksisk eller teratogent hos rotter eller kaniner.
English: Maximum plasma concentration and overall systemic exposure increase with age but no dose adjustment is required in elderly patients.
Danish: Maksimal plasmakoncentration og samlet systemisk eksponering øges med alderen, men der kræves ikke dosisjustering hos ældre patienter.
English: An additional adverse reaction was tremor (common).
Danish: En yderligere bivirkninger var tremor (almindelig).
English: medicines that lower the amount of potassium in your blood.
Danish: medicin, som nedsætter mængden af kalium i blodet.
English: The chances of the capsule shattering will be increased if the capsule is accidentally pierced more than once (step 6).
Danish: Risikoen for, at kapslen splintres, forøges, hvis kapslen ved et uheld perforeres mere end en enkelt gang (trin 6).
English: Patients should be instructed on how to administer the product correctly.
Danish: Patienter skal informeres om korrekt administration af præparatet.
English: The in vitro human serum and plasma protein binding was 94.1-95.3% and 95.1-96.2%, respectively.
Danish: Den humane in vitro serum- og plasmaproteinbinding var henholdsvis 94,1-95,3 % og 95,1-96,2 %.
English: The usual dose is to inhale the content of one capsule each day.
Danish: Den sædvanlige dosis er inhalation af indholdet af én kapsel dagligt.
English: • You should hear a “click” as the capsule is being pierced.
Danish: • Du skal høre et "klik", når kapslen perforeres.
English: The capsules are transparent (uncoloured) and contain a white powder.
Danish: Kapslerne er gennemsigtige (farveløse) og indeholder et hvidt pulver.
English: The frequency of notable QTcF intervals [i.e. >450 ms (males) and >470 ms (females)] and reports of hypokalaemia were similar to placebo.
Danish: Hyppigheden for betydningsfulde QTcF-intervaller [dvs. >450 ms (mænd) og >470 ms (kvinder)] og rapporteret hypokaliæmi var tilsvarende placebo.
English: Therefore indacaterol should not be given together with betaadrenergic blockers (including eye drops) unless there are compelling reasons for their use.
Danish: Indacaterol bør derfor ikke gives sammen med betaadrenerge blokkere (herunder øjendråber), medmindre der er tvingende årsager hertil.
English: Within each system organ class, adverse reactions are ranked by frequency in descending order according to the following convention: 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 (<1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningerne for hver systemorganklasse er ordnet efter hyppighed i faldende orden i henhold til følgende definitioner: 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 (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: It was observed with a higher frequency in female than in male patients and in current smokers than in ex-smokers.
Danish: Hosten blev observeret med en større hyppighed hos kvinder end hos mænd og hyppigere hos aktive rygere end hos tidligere rygere.
English: Keep it dry.
Danish: Den skal holdes tør.
English: Reduction in puffs/day of rescue medication use vs. baseline a
Danish: Reduktion af inhalationer/dag af anfalds-medicin vs. baseline a
English: • Then breathe out.
Danish: • Ånd herefter ud.
English: It is not harmful if these pieces are swallowed or inhaled.
Danish: Det er ikke farligt at sluge eller inhalere disse stykker.
English: 4,764 patients were exposed to indacaterol up to one year at doses up to twice the maximum recommended dose.
Danish: 4.764 patienter blev eksponeret for indacaterol i op til et år ved doser på op til det dobbelte af maksimal anbefalet dosis.
English: Contains lactose (see package leaflet for further information) and gelatin.
Danish: Indeholder lactose (se indlægssedlen for yderligere oplysninger) og gelatine.
English: You may be more likely to get side effects.
Danish: Du kan have større risiko for at få bivirkninger.
English: After intravenous infusion the volume of distribution of indacaterol during the terminal elimination phase was 2557 litres indicating an extensive distribution.
Danish: Efter intravenøs infusion var indacaterols fordelingsvolumen under den terminale eliminationsfase 2557 liter, hvilket indikerer en omfattende distribution.
English: Put a mark in today's box if it helps to remind you of when your next dose is due.
Danish: Sæt et kryds i feltet ud for dags dato, hvis det hjælper dig til at huske, hvornår det er tid til din næste dosis.
English: If a dose is missed the next dose should be taken at the usual time the next day.
Danish: Hvis en dosis glemmes, skal næste dosis tages til sædvanlig tid næste dag.
English: Oslif Breezhaler should only be used during pregnancy if the expected benefits outweigh the potential risks.
Danish: Oslif Breezhaler må kun anvendes under graviditet, hvis de forventede fordele opvejer de mulige risici.
English: Do not inhale a double dose to make up for a forgotten dose.
Danish: Du må ikke inhalere en dobbeltdosis som erstatning for den glemte dosis.
English: If you do not hear a whirring noise: The capsule may be stuck in the capsule chamber.
Danish: Hvis du ikke hører en snurrende lyd: Kapslen kan muligvis sidde fast i kapselkammeret.
English: The bronchodilator effect did not depend on the time of dosing, morning or evening.
Danish: Den bronkodilaterende virkning var ikke afhængig af tidspunktet for dosering, som blev givet enten om morgenen eller om aftenen.
English: PA/Alu/PVC - Alu blister containing 10 hard capsules.
Danish: PA/Alu/PVC - Alu blister, som indeholder 10 hårde kapsler.
English: Percentage of patients who achieved MCID TDI†
Danish: Procentdel af patienter, som opnåede MCID TDI†
English: This medicine relaxes these muscles in the lungs, making it easier for air to get in and out of the lungs.
Danish: Dette lægemiddel afslapper disse muskler i lungerne, hvilket gør det nemmere for luften at komme ind og ud af lungerne.
English: It is not known whether indacaterol/metabolites are excreted in human milk.
Danish: Det vides ikke, om indacaterol/metabolitter udskilles i human mælk.
English: There are no data from the use of indacaterol in pregnant women available.
Danish: Der er utilstrækkelige data fra anvendelse af indacaterol til gravide kvinder.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Do not press the side buttons more than once.
Danish: Tryk ikke sideknapperne ind mere end en enkelt gang.
English: Check your inhaler to see if the capsule is empty and that you have received the full dose.
Danish: Kontroller inhalatoren for at se, om kapslen er tom, og at du har taget hele dosis.
English: Relevant prolongations of QTcF were not detectable in comparison to placebo.
Danish: Relevante forlængelser af QTcF var ikke målbare i forhold til placebo.
English: Therefore the frequency was calculated from clinical trial experience.
Danish: Derfor blev hyppigheden beregnet udfra erfaringer fra kliniske studier.
English: You may notice that your heart is beating faster than usual, or you may have a headache, feel drowsy, feel nauseous or have to vomit.
Danish: Du kan opleve, at dit hjerte slår hurtigere end normalt, eller du kan få hovedpine, føle dig sløv, have kvalme eller kaste op.
English: Renal clearance of indacaterol was, on average, between 0.46 and 1.20 litres/hour.
Danish: Renal clearance af indacaterol var gennemsnitlig mellem 0,46 og 1,20 liter/time.
English: Do not wash your inhaler with water.
Danish: Vask ikke din inhalator med vand.
English: • swollen hands, ankles and feet (oedema)
Danish: • hævede hænder, ankler og fødder (ødem)
English: The side buttons should be facing left and right.
Danish: Sideknapperne skal vende mod højre og venstre.
English: Mean peak improvements in FEV1 relative to baseline were 250-330 ml at steady state.
Danish: De gennemsnitlige maximale forbedringer i FEV1 i forhold til baseline var 250-330 ml ved steady state.
English: Occasionally, very small pieces of the capsule can get past the screen and enter your mouth.
Danish: Undertiden kan meget små stykker af kapslen passere gennem gitteret og ind i din mund.
English: Please read the instructions at the end of this leaflet for more information about how to use the inhaler.
Danish: Læs brugsanvisningen sidst i denne indlægsseddel for at få yderligere oplysninger om, hvordan du bruger inhalatoren.
English: After oral administration of radiolabelled indacaterol in a human ADME (absorption, distribution, metabolism, excretion) study, unchanged indacaterol was the main component in serum, accounting for about one third of total drug-related AUC over 24 hours.
Danish: Efter oral administration af radioaktivt mærket indacaterol i et humant ADME-forsøg (absorption, distribution, metabolisme, ekskretion), var indacaterol, som uændret form den primære komponent i serum og udgjorde ca. en tredjedel af det samlede lægemiddelrelaterede AUC over 24 timer.
English: Oslif Breezhaler should be administered at the same time of the day each day.
Danish: Oslif Breezhaler bør tages på samme tidspunkt hver dag.
English: REMEMBER:
Danish: HUSK:
English: Pharmacokinetic data were obtained from a number of clinical studies, from healthy volunteers and COPD patients.
Danish: De farmakokinetiske data er indhentet fra en række kliniske forsøg, fra raske frivillige og KOLpatienter.
English: Percentage of days with no rescue medication use a
Danish: Procentdel af dage uden brug af anfalds-medicin
English: Of these patients, 2,611 were on treatment with 150 microgram once daily and 1,157 on treatment with 300 microgram once daily.
Danish: Ud af disse patienter blev 2.611 behandlet med 150 mikrogram pr. dag, og 1.157 blev behandlet med 300 mikrogram pr. dag.
English: c: indacaterol 300 microgram, formoterol and placebo MCID = minimal clinically important difference (≥1 point change in TDI, ≥4 point change in SGRQ) n/e= not evaluated at six months
Danish: c: indacaterol 300 mikrogram, formoterol og placebo MCID = minimal clinically important difference (ændring på ≥1 point i TDI, ændring på ≥4 point i SGRQ) i/e= ikke evalueret efter seks måneder