FrancophonIA/ELRC3.0 huggingface dataset:
English: Intravenous gemcitabine has become widely accepted as the standard of chemotherapy care for advanced pancreatic cancer but has yielded disappointing results as combination treatment in patients with locally advanced (nonresectable) or metastatic pancreatic cancer and the MAH considered that gemcitabine monotherapy remains the standard of chemotherapy care for advanced/metastatic, nonresectable pancreatic adenocarcinoma.
Danish: Intravenøs gemcitabin har vundet udbredelse som den accepterede standard inden for behandling med kemoterapi ved fremskreden pancreascancer, men resultaterne af kombinationsbehandlingen af patienter med lokalt fremskreden (ikke-resektabel) eller metastaserende pancreascancer har været skuffende, og indehaveren af markedsføringstilladelsen anser fortsat monoterapi med gemcitabin for at være standarden inden for kemoterapibehandling af fremskreden/metastaserende, ikke-resektabel pancreatisk adenokarcinom.
English: “Gemcitabine is indicated in locally advanced or metastatic epithelial ovarian carcinoma, in combination with carboplatin, in patients with relapsed disease following a recurrence free interval of at least 6 months after-platinum based, first-line therapy”
Danish: “Gemcitabin er indikeret ved lokalt fremskreden eller metastaserende epitelial ovariecancer, i kombination med carboplatin, hos patienter, der har haft tilbagefald efter en recidivfri periode på mindst seks måneder efter platinbaseret førstevalgsbehandling.”
English: • Injection site reactions-mainly mild in nature
Danish: Reaktioner på administrationsstedethovedsageligt milde af natur
English: Irregular heart beat (arrhythmia)
Danish: Uregelmæssig puls (arytmi)
English: Difficulty breathing
Danish: Vejrtrækningsproblemer
English: Gemcitabine should be used with caution in patients with hepatic insufficiency or with impaired renal function as there is insufficient information from clinical studies to allow clear dose recommendation for this patient population (see section 4.2).
Danish: Gemcitabin skal anvendes med forsigtighed til patienter med nedsat nyre- eller leverfunktion, da der er utilstrækkelige data fra kliniske forsøg til at give entydige dosisrekommandationer til disse patientpopulationer (se pkt.
English: White to off-white plug or powder.
Danish: Gemzar er et hvidt til off-white pulver.
English: The CHMP was of the opinion that the MAH proposal was acceptable, but considered that interactions and conditions relevant for all cytotoxics are expected for gemcitabine and that adequate warning should therefore be provided in section 4.4 and 4.5.
Danish: CHMP mente, at forslaget fra indehaveren af markedsføringstilladelsen var acceptabelt, men at der, fordi der forventes interaktioner og forhold i forbindelse med gemcitabin, som har relevans for alle cytotoksiske stoffer, bør advares tilstrækkeligt herom under pkt.
English: Omit dose * *Treatment omitted will not be re-instated within a cycle before the absolute granulocyte count reaches at least 500 (x106/l) and the platelet count reaches 50,000 (x106/l).
Danish: Spring dosis over Udeladt behandling vil ikke blive genoptaget i løbet af en cyklus, før det absolutte granulocyttal når mindst 500 (x 10 6/l) og blodpladetallet når 50.000 (x 10 6/l).
English: Cellular metabolism and mechanism of action: Gemcitabine (dFdC), which is a pyrimidine antimetabolite, is metabolised intracellularly by nucleoside kinase to the active diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides.
Danish: Cellulær metabolisme og virkningsmekanisme Gemcitabin (difluordeoxycytidin DfdC), som er en pyrimidin antimetabolit, metaboliseres intracellulært af nukleosid-kinaser til de aktive difosfat-(dFdCDP) og trifosfat-(dFdCTP) nukleosider.
English: • Increased gamma-glutamyl transferase (GGT)
Danish: Forhøjet bilirubin Forhøjet gammaglutamyltransferase (GGT)
English: For Section 4.2, the MAH proposed a harmonised wording, addressing in particular the sections about dosage adjustment, about impaired renal function and on precautions in administration.
Danish: 4.2, der især vedrører afsnittene om dosisjustering, nedsat nyrefunktion samt forsigtighedsregler i forbindelse med administration.
English: Dosage reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient.
Danish: Dosisreduktionen mellem hver cyklus eller i løbet af en cyklus kan baseres på den grad af toksicitet, som patienten oplever.
English: Hydrochloric acid (E507) (for pH adjustment) Sodium hydroxide (E524) (for pH adjustment)
Danish: Natriumhydroxid (til pH justering).
English: • ovarian cancer, together with carboplatin.
Danish: - Ovariekræft, hvor det bruges sammen carboplatin.
English: Lithuania Eli Lilly Holdings Limited Kingsclere Road, Basingstoke, Hampshire RG21 6XA United Kingdom
Danish: Eli Lilly Holdings Limited Kingsclere Road, Basingstoke, Hampshire RG21 6XA Storbritannien
English: Eli Lilly Holdings Linited, Kingsclere Road, Basingstoke,
Danish: Eli Lilly Holdings Limited, Kingsclere Road, Basingstoke,
English: Mannitol (E421), sodium acetate, hydrochloric acid and sodium hydroxide.
Danish: LISTE OVER HJÆLPESTOFFER Mannitol (E421), natriumacetat, saltsyre og natriumhydroxid.
English: • Absolute granulocyte count < 500 x 106/l for more than 5 days
Danish: • Absolut granulocyttal < 500 x 106/l i mere end 5 dage • Absolut granulocyttal < 1000 x 10
English: Difficulty breathing (it is very common to have mild breathing difficulty soon after the Gemzar infusion which soon passes, however uncommonly or rarely there can be more severe lung problems)
Danish: Vejrtrækningsproblemer (det er meget almindeligt at have lette vejrtrækningsproblemer lige efter Gemzar-infusionen, hvilket hurtigt går over.
English: - If you have further questions, please ask your doctor, nurse or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller apoteket.
English: Also, a statistically significant prolongation of the time to progression from 0.9 to 2.3 months (log-rank p<0.0002) and a statistically significant prolongation of median survival from 4.4 to 5.7 months (log-rank p<0.0024) was observed in patients treated with gemcitabine compared to patients treated with 5-fluorouracil.
Danish: Desuden sås en statistisk signifikant forlængelse af tiden til progression fra 0,9 til 2,3 måneder (log-rank p<0,0002) og en statistisk signifikant forlængelse af median overlevelse fra 4,4 til 5,7 måneder (log-rank p<0,0024) blev observeret hos gemcitabinbehandlede patienter i forhold til patienter behandlet med 5-fluorouracil.
English: Skin rash- allergic skin rash, frequently itchy Hair loss
Danish: Hududslæt, allergisk hududslæt, hyppig kløe Hårtab
English: Disposal Any unused product should be disposed of in accordance with local requirements.
Danish: Ikke anvendt opløsning bør bortskaffes i overensstemmelse med lokale krav.
English: Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally]
Danish: Indehaveren af markedsføringstilladelsen og fremstiller [Se bilag I - Udfyldes nationalt]
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains gemcitabine hydrochloride equivalent to 200 mg gemcitabine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Et hætteglas indeholder gemcitabinhydrochlorid, svarende til 200 mg gemcitabin.
English: If particulate matter is observed, do not administer.
Danish: Hvis der observeres partikler, må opløsningen ikke anvendes.
English: Overall, the MAH therefore considered gemcitabine plus paclitaxel combination chemotherapy to be an effective regimen in patients with metastatic breast cancer, with an expected and manageable toxicity and a favourable risk-benefit profile.
Danish: Indehaveren af markedsføringstilladelsen anså derfor generelt kemoterapi med en kombination af gemcitabin og paclitaxel for at være et effektivt regime med en forventet og kontrollerbar toksicitet og et gunstig risk/benefit-forhold til patienter med metastaserende brystcancer.
English: Lilly France S.A. 2 rue du colonel Lilly 67642 Fegersheim France
Danish: Lilly France S.A. 2 rue du colonel Lilly 67642 Fegersheim Frankrig
English: • Elevation of liver transaminases (AST and ALT) and alkaline phosphatase
Danish: Forhøjede levertransaminaser (ASAT/ALAT) og basiske fosfataser
English: The CHMP noted the pivotal study JHQJ was powered to detect differences in TtDP in overall survival and that the pivotal study for the ovarian cancer had a specific population consisting of platinum sensitive patients with a very poor prognosis and the CHMP was of the opinion that the proposed wording was in accordance with the submitted study for the marketing authorisation in this indication.
Danish: CHMP bemærkede, at den pivotale undersøgelse, JHQJ, fokuserede på at påvise forskelle i TtDP ved samlet overlevelse, og at den pivotale undersøgelse vedrørende ovariecancer havde en specifik population bestående af platinsensitive patienter med en meget dårlig prognose.
English: • Thrombocytosis
Danish: 4.2) Thrombocytopeni
English: The volume of distribution of the peripheral compartment was 47.4 l/m2.
Danish: Fordelingsvolumen af det perifere fordelingsrum var 47,4 l/ m Volumet for det perifere fordelingsrum var ikke afhængig af køn.
English: Each vial contains 200 or 1000 mg of gemcitabine (as gemcitabine hydrochloride).
Danish: Hvert hætteglas indeholder 200 mg eller 1000 mg gemcitabin (som gemcitabinhydroklorid).
English: Gemcitabine, in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy.
Danish: “Gemcitabin i kombination med paclitaxel er indikeret til behandling af patienter med ikke-resektabel, lokalt recidiverende eller metastaserende brystcancer, som har haft tilbagefald efter adjuverende/neoadjuverende kemoterapi.
English: The active substance is gemcitabine.
Danish: Gemzar indeholder: - Aktivt stof: gemcitabin.
English: Respiratory, thoracic and mediastinal disorders Pulmonary oedema
Danish: Luftveje, thorax og mediastinum Pulmonært ødem
English: In a randomised phase III study of 529 patients with inoperable, locally recurrent or metastatic breast cancer with relapse after adjuvant/neoadjuvant chemotherapy, gemcitabine in combination with paclitaxel showed a statistically significant prolongation of time to documented disease progression from 3.98 to 6.14 months (log-rank p=0.0002) in patients treated with gemcitabine/paclitaxel compared to patients treated with paclitaxel.
Danish: I en randomiseret fase III undersøgelse af 529 patienter med inoperabel, lokalt recidiverende eller metastatisk brystcancer, som havde fået genvækst efter adjuverende/neoadjuverende kemoterapi, havde patienter behandlet med gemcitabin/paclitaxel en statistisk signifikant forlængelse af tiden til dokumenteret progression i sygdommen fra 3,98 måneder til 6,14 måneder (log-rank p=0,0002) i forhold til paclitaxel-behandlede patienter.
English: Patients receiving gemcitabine should be monitored prior to each dose for platelet, leucocyte and granulocyte counts.
Danish: Patienter i behandling med gemcitabin skal have bestemt trombocyttal, leukocyttal og granulocyttal før hver dosis.
English: Strength Pharmaceutical form
Danish: Lægemidlets navn (særnavn) Styrke Lægemiddelform
English: Uncommon • Interstitial pneumonitis (see section
Danish: Interstitiel pneumoni (se pkt.
English: Treatment will start on day 1 of the next cycle once the absolute granulocyte count reaches at least 1,500 (x106/l) and the platelet count reaches 100,000 (x106/l).
Danish: Behandling vil blive påbegyndt på dag 1 af næste cyklus, når det absolutte granulocyttal når mindst 1.500 (x 10 6/l) og blodpladetllet når 100.000
English: In a randomised phase III study of 126 patients with advanced or metastatic pancreatic cancer, gemcitabine showed a statistically significant higher clinical benefit response rate than 5-fluorouracil (23.8% and 4.8% respectively, p=0.0022).
Danish: I en randomiseret fase III undersøgelse af 126 patienter med fremskreden eller metastatisk pancreascancer viste gemcitabin en statistisk signifikant højere responsrate end 5-fluorouracil udtrykt ved klinisk forbedring (henholdsvis 23,8% og 4,8%; p=0,0022).
English: Gemcitabine is indicated for the treatment of patients with locally advanced or metastatic epithelial ovarian carcinoma, in combination with carboplatin, in patients with relapsed disease following a recurrence-free interval of at least 6 months after platinum-based, first-line therapy.
Danish: Gemcitabin er indiceret til behandling af patienter med med lokalt fremskreden eller metastatisk epitelial ovariekarcinom i kombination med carboplatin og til patienter med recidiverende sygdom efter en periode på mindst 6 måneder uden tilbagefald efter platinbaseret 1. linjes behandling.
English: Pancreatic cancer
Danish: Pancreascancer
English: • very rare: affects less than 1 user in 10,000
Danish: • Meget sjældne bivirkninger: Forekommer hos færre end 1 ud af 10.000 patienter.
English: Nervous system disorders Cerebrovascular accident
Danish: Nervesystemet Hjerneblødning
English: “Gemcitabine, in combination with cisplatin is indicated as first line treatment of patients with locally advanced or metastatic non small cell lung cancer.
Danish: “Gemcitabin i kombination med cisplatin er indikeret som førstevalgsbehandling af patienter med lokalt fremskreden eller metastaserende ikke-småcellet lungecancer.
English: HOW TO STORE GEMZAR
Danish: SÅDAN SKAL DU BRUGE GEMZAR
English: The most commonly reported adverse drug reactions associated with Gemzar treatment include: nausea with or without vomiting, raised liver transaminases (AST/ALT) and alkaline phosphatase, reported in approximately 60% of patients; proteinuria and haematuria reported in approximately 50% patients; dyspnoea reported in 10-40% of patients (highest incidence in lung cancer patients); allergic skin rashes occur in approximately 25% of patients and are associated with itching in 10% of patients.
Danish: De mest almindelige rapporterede bivirkninger forbundet med gemcitabinbehandling omfatter: kvalme med eller uden opkastning, forhøjede levertransaminaser (ASAT/ALAT) og alkalisk fosfataser, disse er rapporteret hos ca. 60% af patienterne.
English: Take special care with Gemzar:
Danish: Vær ekstra forsigtig med at bruge Gemzar
English: Rare • Hypotension
Danish: Hypotension.
English: Mean steady state volume of distribution (Vss): 150 l/m2 (range 96-228 l/m2).
Danish: Gennemsnitlig steady-state fordelingsvolumen (VSS): 150 l/m
English: Number (%) of Patients MVAC (methotrexate, vinblastine, doxorubicin and cisplatin) arm (N=196)
Danish: Grad 3 og 4 bivirkninger MVAC versus gemcitabin plus cisplatin Antal (%) patienter MVAC (methotrexat, vinblastin, doxorubicin og cisplatin) arm (N=196)
English: In another randomised phase III study of 135 patients with stage IIIB or IV NSCLC, a combination of gemcitabine and cisplatin showed a statistically significant higher response rate than a combination of cisplatin and etoposide (40.6% and 21.2%, respectively, p=0.025).
Danish: I en anden randomiseret fase III undersøgelse af 135 patienter med ikke-småcellet lungecancer stadium IIIB eller IV havde en kombination af gemcitabin og cisplatin en statistisk signifikant højere responsrate end en kombination af cisplatin og etoposid (henholdsvis 40.6% og 21,2%; p=0,025).
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution Read the package leaflet before use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intravenøs brug efter rekonstitution.
English: • bladder cancer, together with cisplatin.
Danish: - Blærekræft, hvor det bruges sammen med cisplatin.
English: Combination use The recommended dose for gemcitabine is 1250 mg/m2 body surface area given as a 30-minute intravenous infusion on Day 1 and 8 of the treatment cycle (21 days).
Danish: Kombinationsbehandling Den anbefalede dosis af gemcitabin er 1250 mg/m2 indgivet intravenøst over 30 minutter på dag 1 og 8 i en behandlingscyklus (21 dage).
English: Other sections of the SPC: While the full harmonisation of the quality dossier was not part of the scope of the referral, the sections of the SPC (in particular sections 2 and 6) and the corresponding Package Leaflet sections relating to Quality were assessed and harmonised.
Danish: Produktresuméets øvrige punkter: Selvom om den indbragte sag ikke vedrørte en fuldstændig harmonisering af kvalitetsdossieret, blev produktresuméets punkter (navnlig pkt.
English: The resulting solution is clear and ranges in colour from colourless to light straw-coloured.
Danish: Den rekonstituerede opløsning er klar og farveløs til lys strågul.
English: A statistically significant prolongation of the time to progression, from 3.7 to 5.6 months (log-rank p<0.0012) and a statistically significant prolongation of median survival from 7.6 months to 9.1 months (log-rank p<0.004) was observed in patients treated with gemcitabine/cisplatin compared to patients treated with cisplatin.
Danish: En statistisk signifikant forlængelse af tiden til progression i sygdommen fra 3,7 til 5,6 måneder (log-rank p<0,0012) samt en statistisk signifikant forlængelse af median overlevelse fra 7,6 til 9,1 måneder (log-rank p<0,004) blev observeret hos patienter behandlet med gemcitabin/cisplatin i forhold til cisplatinbehandlede patienter.
English: Gemcitabine, in combination with cisplatin is indicated as first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Danish: Gemcitabin er indiceret som 1. linjes behandling i kombination med cisplatin til patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungecancer (NSCLC).
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Danish: DATO FOR FØRSTE MAKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Combination use in breast cancer
Danish: Kombinationsbehandling ved brystcancer
English: To reconstitute, add 5 ml of sterile sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, to the 200 mg vial or 25 ml sterile sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, to the 1000 mg vial.
Danish: Ved rekonstitution tilsættes 5 ml steril natriumklorid 9 mg/ml (0,9%) injektionsvæske, opløsning (uden konservering) til hætteglasset med 200 mg eller 25 ml steril natriumklorid 9 mg/ml (0,9%) injektionsvæske, opløsning (uden konservering) til hætteglasset med1000 mg.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald bør bortskaffes i overensstemmelse med lokale krav.
English: Gemcitabine and carboplatin combination therapy When given in combination with carboplatin the pharmacokinetics of gemcitabine were not altered
Danish: Kombinationsbehandling med gemcitabin og carboplatin Pharmakokinetikken for gemcitabin ændres ikke, når det gives i kombination med carboplatin.
English: The MAH agreed that the indication is redundant because the first line treatment of pancreatic treatment with gemcitabine is standard of care and agreed to remove it.
Danish: Indehaveren af markedsføringstilladelsen var enig i, at indikationen er overflødig, da førstevalgsbehandlingen med gemcitabin er standard ved behandling af pancreascancer, og indvilligede i at slette den. CHMP slettede også omtalen af performance status og vedtog følgende ordlyd:
English: Lilly France S.A.S 2 Rue du Colonel Lilly 6740 Fegersheim France
Danish: Rumænien Lilly France S.A.S 2 Rue du Colonel Lilly 6740 Fegersheim
English: FARMASERVE LILLY S.A.Cl 15 Km National Road Athens-Lamia Kifissia, 14564 Greece
Danish: Grækenland FARMASERVE LILLY S.A.Cl 15 Km National Road
English: • very common: affects more than 1 user in 10
Danish: • Meget almindelige bivirkninger: Forekommer hos flere end 1 ud af 10 patienter.
English: In a randomised phase III study of 522 patients with inoperable, locally advanced or metastatic NSCLC, gemcitabine in combination with cisplatin showed a statistically significant higher response rate than cisplatin alone (31.0% and 12.0%, respectively, p<0.0001).
Danish: I en randomiseret fase III undersøgelse af 522 patienter med inoperabel, lokalt fremskreden eller metastatisk ikke-småcellet lungecancer viste gemcitabin i kombination med cisplatin en statistisk signifikant højere responsrate end cisplatin alene (henholdsvis 31,0% og 12,0%; p<0,0001).
English: Dose modification of gemcitabine within a cycle for breast cancer, given in combination with paclitaxel Absolute granulocyte count (x 106/l)
Danish: Dosisændring af gemcitabin givet i kombination med paclitaxel i løbet af en cyklus ved brystcancer Absolut granulocyttal (x 106/l)
English: • Thrombocytopaenia
Danish: Trombocytopeni
English: PHARMACEUTICAL FORM AND CONTENTS 1 vial, powder for solution for infusion
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 1 hætteglas, pulver til infusionsvæske, opløsning
English: Belgium ELI LILLY Benelux s.a. Rue De L'Etuve 52
Danish: ELI LILLY Benelux s.a. Rue De L'Etuve 52 B-1000 Brussels Belgien
English: Therefore, men being treated with gemcitabine are advised not to father a child during and up to 6 months after treatment and to seek further advice regarding cryoconservation of sperm prior to treatment because of the possibility of infertility due to therapy with gemcitabine (see section 4.6).
Danish: Det anbefales også at søge yderligere rådgivning angående kryokonservering af sæd før behandling, på grund af muligheden for infertilitet som følge af behandling med gemcitabin (se pkt 4.6).
English: Finally, a number of additional minor comments, including comments to remaining sections of the SPC, were made by the CHMP and implemented directly in the SPC text.
Danish: Endelig fremsatte CHMP en række mindre væsentlige bemærkninger, bl.a. vedrørende de resterende punkter i produktresuméet.
English: When gemcitabine is administered daily, high mortality among the animals but minimal antitumoural activity is observed.
Danish: Gives gemcitabin daglig, ses høj letalitet og ringe tumoraktivitet.
English: Each vial contains 200 or 1000 mg of gemcitabine.
Danish: Hvert hætteglas indeholder 200 mg eller 1000 mg gemcitabin.
English: SPECIAL STORAGE CONDITIONS Unopened vial: Store below 30°C Read the leaflet for the shelf life of the reconstituted product
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Uåbnet hætteglas: Opbevares under 30ºC.
English: The CHMP reviewed the information regarding the use of Gemcitabine in ovarian cancer and was of the opinion that the combination gemcitabine/carboplatin is an option in second line therapy in patients with sensitive platinum disease and an alternative in patients with previous paclitaxel/carboplatin toxicity (Therefore the CHMP retained the indication in ovarian cancer in the harmonised SPC, with the wording:
Danish: CHMP gennemgik oplysningerne om anvendelse af gemcitabin til behandling af ovariecancer og var af den opfattelse, at kombinationen af gemcitabin og carboplatin er en andetvalgsbehandlingsmulighed for patienter med en platinsensitiv sygdom og et alternativ for patienter med tidligere paclitaxel/carboplatintoksicitet.
English: In fertility studies gemcitabine caused hypospermatogenesis in male mice (see section 5.3).
Danish: I fertilitetsstudier forårsagede gemcitabin hypospermatogenese i hanmus (se pkt.
English: Dose modification of gemcitabine within a cycle for ovarian cancer, given in combination with carboplatin Absolute granulocyte count (x 106/l)
Danish: Dososændring af gemcitabin givet i kombination med carboplatin i løbet af en cyklus ved ovariecancer Absolut granulocyttal (x 106/l)
English: Gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas.
Danish: Gemcitabin er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk adenokarcinom i pancreas.
English: Interstitial pneumonitis (scarring of the air sacs of the lung) Spasm of the airways (wheeze) Abnormal chest X ray/scan (scarring of the lungs)
Danish: Interstitiel lungebetændelse (ardannelse i lungernes luftsække) Kramper i luftvejene (hvæsende vejrtrækning) Unormalt røntgenbillede af brystkassen (arvævsdannelse i lungerne)