FrancophonIA/ELRC3.0 huggingface dataset:
English: EXUBERA-Service-Center/Service Client local
Danish: Klanteninformatiedienst voor EXUBERA/ EXUBERA-Service-Center/Service Client local EXUBERA
English: The Marketing Authorisation Holder must implement nationally an educational plan, prior to marketing, and as agreed with the competent authorities in the Member States.
Danish: inden lægemidlet markedsføres, og som aftalt med de ansvarlige myndigheder i
English: Such reactions to insulin or the excipients may, for example, be associated with generalised skin reactions, angio-oedema, bronchospasm, hypotension and shock and may be life-threatening (see section 4.4 Respiratory).
Danish: Disse reaktioner over for insulin eller hjælpestofferne kan muligvis være forbundet med generaliseret hudreaktion, angioødem, bronkospasme, hypotension og shock, og de kan være livstruende (se pkt.
English: In clinical trials, insulin antibodies developed more frequently and mean levels of insulin antibodies were higher in patients who switched their subcutaneous human insulin to EXUBERA compared to subjects who remained on subcutaneous human insulin.
Danish: I kliniske forsøg dannes insulinantistoffer hyppigere og det gennemsnitlige insulinantistof-niveau er højere hos patienter, som skiftede deres subkutane humane insulin ud med EXUBERA sammenlignet med forsøgspersoner, der forblev i behandling med subkutant humant insulin.
English: In non-diabetic subjects with COPD, the absorption of inhaled human insulin appeared greater compared with that in subjects without COPD (see section 4.4).
Danish: Hos ikke-diabetikere med KOL er absorptionen af inhaleret humant insulin større sammenlignet med forsøgspersoner uden KOL (se pkt.
English: Figure 4: Mean changes in serum free insulin concentrations (µU/mL) after inhalation of 4mg of human insulin or subcutaneous injection of 12 IU fast-acting human insulin in obese subjects with
Danish: Figur 4: Gennemsnitlig ændring i serumfrie insulinkoncentrationer (μE/ml) efter inhalation af 4 mg humant insulin eller subkutan injektion af 12 E hurtigtvirkende humant insulin hos overvægtige forsøgspersoner med type 2 diabetes.
English: Discontinuation of EXUBERA therapy after 2 years resulted in resolution of treatment group differences within 6 weeks (see sections 4.4 and 5.1).
Danish: Seponering af EXUBERA-behandling efter 2 år førte til, at forskellene mellem behandlingsgrupperne forsvandt inden for 6 uger (se pkt.
English: Squeeze the two chamber release buttons at the same time on the side of the base.
Danish: Pres de to kammerudløsningsknapper ind samtidigt på siden af hoveddelen.
English: In contrast, exposure to other people's cigarette smoke may decrease the amount of insulin your body
Danish: I modsætning hertil kan passiv rygning nedsætte mængden af insulin, som kroppen optager.
English: Hold the black ring at the bottom of the base and use it to pull the base out of the chamber.
Danish: Tag fat i den sorte ring i bunden af hoveddelen og
English: Medicines that may cause your blood sugar to rise include corticosteroids (used to treat inflammatory conditions, except topical administration), danazol (used for the treatment of some female hormonal disorders), oral contraceptives (used for birth control), thyroid hormones (used for the treatment of malfunction of the thyroid gland), growth hormones (used in endocrine conditions), sympathomimetic agents (used for the treatment of asthma) and thiazides (used in special endocrine conditions).
Danish: Blodsukkeret kan stige, hvis De bruger binyrebarkhormoner (som bruges til behandling af betændelsestilstande; undtaget er produkter til anvendelse på huden), danazol (bruges til behandling af visse kvindelige hormonforstyrrelser), orale antikonceptionsmidler (bruges til svangerskabsforebyggelse), thyreoideahormoner (bruges til behandling af funktionsfejl i skjoldbruskkirtlen), væksthormon (bruges ved endokrine lidelser), sympatomimetika (bruges til behandling af astma) og thiazider (bruges ved specielle endokrine lidelser).
English: In Phase 2/3 trials, 9 out of 2498 subjects treated with EXUBERA were discontinued from trials due to a decline in pulmonary function whose end of study FEV1 showed a decline of ≥ 15% from baseline.
Danish: I fase 2/3 forsøg afbrød 9 ud af 2498 forsøgspersoner behandlingen med EXUBERA på grund af fald i
English: Administration of fluticasone 30 minutes prior to EXUBERA did not affect the pharmacokinetics of EXUBERA in non-diabetic subjects with mild-moderate asthma (see section 4.5).
Danish: Indgift af fluticason 30 minutter før EXUBERA ændrede ikke EXUBERAs farmakokinetik hos ikkediabetikere med mild-moderat astma (se pkt.
English: As with other insulins, hypoglycaemia was the most frequently observed undesirable effect in patients
Danish: Som for andre insulinpræparater er hypoglykæmi også den hyppigst forekommende bivirkning hos patienter i EXUBERA-behandling.
English: If 3 mg blisters are unavailable, use only two 1 mg blisters as replacement.
Danish: Hvis blistere à 3 mg ikke er tilgængelige, anvendes kun 2 blistere à 1 mg som erstatning.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE AUTHORISATION HOLDER(S) RESPONSIBLE FOR
Danish: A. FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG
English: If you are unsure contact your doctor,
Danish: Hvis De er usikker, skal De kontakte lægen, diabetessygeplej
English: Turn the used IRU about a one-quarter turn counter clockwise towards the unlock symbol.
Danish: Drej den brugte insulinfrigivelsesenhed ca. ¼ omgang mod uret hen til aflåsningssymbolet.
English: Mean Glucose Infusion Rate (GIR) Normalised to GIRmax for Each Subject Treatment When human insulin is inhaled, the onset of glucose lowering activity is within 10-20 minutes, the maximum effect is exerted approximately 2 hours after inhalation.
Danish: Når humant insulin inhaleres, indtræder den glucosesænkende virkning inden for 10-20 minutter, den maksimale effekt topper ca. 2 timer efter inhalation.
English: Dose adjustments may be required based on meal size and nutrient composition, time of day (higher insulin requirements in the morning), pre-meal blood glucose concentration, recent or planned
Danish: Det kan være nødvendigt at justere dosis på grund af måltidets størrelse, næringsstoffernes sammensætning, tidspunkt på døgnet (højere insulinbehov om morgenen), blodsukkerkoncentration forud for måltidet, nylig eller forventet fysisk aktivitet.
English: You should also tell your doctor if you develop any other increasing breathing difficulties while
Danish: De bør fortælle lægen, hvis de får yderligere vejrtrækningsproblemer, mens De tager EXUBERA.
English: For information on the treatment of hypoglycaemia, see the end of section 4 “Possible side effects”.
Danish: Yderligere oplysninger om behandling af hypoglykæmi findes sidst i punkt 4 ” Hvilke mulige bivirkninger EXUBERA har”.
English: (Seen in more than 1 in 10 patients)
Danish: Bivirkninger, som er rapporteret meget hyppigt (ses hos mere end 1 ud af 10 patienter)
English: Medicines that may cause your blood sugar to fall include diabetes tablets, angiotensin converting enzyme (ACE) inhibitors (used for the treatment of certain heart conditions, high blood pressure or elevated protein/albumin in the urine), monoamine oxidase (MAO) inhibitors (used for the treatment of depression), certain beta-blockers (used for the treatment of certain heart conditions and high blood pressure), salicylates (e.g. aspirin, used to relieve pain and lower fever) and
Danish: Blodsukkeret kan falde, hvis De bruger følgende lægemidler: tabletter mod diabetes, angiotension konverterende enzym (ACE) hæmmere (bruges til behandling af visse hjerteproblemer, forhøjet blodtryk eller forhøjet protein/albumin i urinen), monoaminooxidase (MAO) hæmmere (bruges til behandling af depression), visse beta-blokkere (bruges til behandling af visse hjerteproblemer og forhøjet blodtryk), salicylater (f.eks. aspirin, bruges som smertestillende og febernedsættende middel)
English: Turn the top of the IRU clockwise until the blue line points to the lock symbol on the top of the base.
Danish: Drej toppen af insulinfrigivelsesenheden med uret, indtil den blå streg peger mod låsesymbolet på
English: An approximately 40% higher bioavailability of three 1 mg unit dose blisters compared to one 3 mg unit dose blister was observed in healthy subjects.
Danish: Der blev set en ca. 40% højere biotilgængelighed af 3 blistere à 1 mg sammenlignet med 1 blister à 3 mg hos raske forsøgspersoner.
English: In order to be able to take action immediately, patients should carry glucose with them at all times.
Danish: Patienten bør altid have glucose på sig for omgående at kunne tage dette, hvis det skulle blive nødvendigt.
English: You should change your insulin inhaler once a year from the date you first use the inhaler.
Danish: De bør udskifte insulininhalatoren 1 gang årligt efter at den er taget i brug.
English: Inhaled human insulin is absorbed as rapidly as fast-acting insulin analogues and more rapidly than subcutaneously administered fast-acting human insulin in healthy subjects and in subjects with type 1 or type 2 diabetes (see Figure 4).
Danish: Inhaleret humant insulin absorberes lige så hurtigt som hurtigtvirkende insulin-analoger og hurtigere end hurtigtvirkende humant insulin indgivet subkutant hos raske forsøgspersoner og forsøgspersoner med type 1 eller type 2 diabetes (se figur 4).
English: If you suspect an allergy to EXUBERA, speak to your doctor immediately.
Danish: Hvis De tror, De er overfølsom over for EXUBERA, skal De straks tale med Deres læge.
English: Inhaled human insulin has a duration of glucose lowering activity comparable to subcutaneously administered fast-acting human insulin and longer than fast-acting insulin analogues (see Figure 1).
Danish: Inhaleret humant insulin har glucosesænkende virkningsvarighed sammenlignelig med subkutant indgivet hurtigtvirkende humant insulin og længere end hurtigtvirkende insulin-analoger (se figur 1).
English: During intercurrent respiratory illness (e.g. bronchitis, upper respiratory tract infections) close monitoring of blood glucose concentrations and dose adjustment may be required on an individual
Danish: I forbindelse med interkurrente respiratoriske sygdomme (f.eks. bronkitis, øvre luftvejsinfektioner) kan tæt blodsukkerkontrol og individuel dosisjustering være nødvendig (se pkt.
English: Intrasubject variability of time to peak insulin concentrations was less for inhaled human insulin than for subcutaneous fast-acting human insulin in subjects with type 1 or 2 diabetes.
Danish: Den intraindividuelle variation i tiden til opnåelse af maksimale insulinkoncentrationer var lavere for inhaleret insulin end for subkutant hurtigtvirkende humant insulin hos forsøgspersoner med type 1 eller 2 diabetes.
English: It also promotes the uptake of amino acids into cells and promotes protein synthesis and enhances the uptake of potassium into cells.
Danish: Humant insulin fremskynder ligeledes optagelsen af aminosyrer i cellerne samt fremskynder proteinsyntesen og øger kaliumoptagelsen i
English: • A pack containing 30, 60, 90, 180 and 270 x 1 of 1 mg PVC/Aluminium perforated unit dose
Danish: • Karton med 30, 60, 90, 180 og 270 x 1 à 1 mg PVC/aluminium perforeret enkeltdosisblister
English: In obese subjects with type 2 diabetes, intrasubject variability was comparable to or less than that of subcutaneously administered fast-acting human insulin for Cmax and AUC.
Danish: Hos overvægtige forsøgspersoner med type 2 diabetes, er den intraindividuelle variation sammenlignelig med, eller mindre end, subkutant administreret hurtigtvirkende humant insulin, hvad angår Cmax og AUC.
English: They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
Danish: Symptomer på hypoglykæmi opstår sædvanligvis pludseligt og kan omfatte koldsved, kold bleg hud, træthed, nervøsitet eller tremor, angst, usædvanlig træthed eller svaghed, konfusion, koncentrationsbesvær, døsighed, ekstrem sultfornemmelse, synsforstyrrelser, hovedpine, kvalme og palpitationer.
English: Do not get the inside of the IRU wet.
Danish: Gør ikke indersiden af insulinfrigivelsesenheden våd.
English: Do NOT put the chamber in the dishwasher.
Danish: Kom ikke hoveddelen i vand.
English: In clinical trials involving patients with type 2 diabetes not sufficiently controlled with oral agents alone, patients using a regimen of EXUBERA alone or in combination with oral agents, had greater improvements in HbA1c compared with patients treated with oral agents alone.
Danish: I kliniske forsøg, der inkluderer patienter med type 2 diabetes, der ikke var velkontrollerede på orale præparater alene, har patienter, der kun behandles med EXUBERA eller i kombination med orale præparater, større gunstig ændring i HbA1c sammenlignet med de patienter, der kun bliver behandlet med orale præparater.
English: Also, read the Patient Information Leaflet for, EXUBERA 1 mg and 3 mg powder for inhalation predispensed.
Danish: Læs også indlægssedlen for EXUBERA 1 mg og 3 mg afdelt inhalationspulver.
English: • A pack containing 30, 60, 90, 180 and 270 x 1 of 3 mg PVC/Aluminium perforated unit dose
Danish: • Karton med 30, 60, 90, 180 og 270 x 1 à 3 mg PVC/aluminium perforeret enkeltdosisblister
English: These small treatment group differences resolved within 6 weeks upon discontinuation after 2 years of treatment (see sections 4.8 and 5.1).
Danish: Disse små forskelle mellem behandlingsgrupperne forsvandt inden for 6 uger efter seponering efter 2 års behandling (se pkt.
English: Symptoms that may tell you that your blood sugar levels are too high: thirst, increased need to pass water, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heartbeat, and glucose and ketone bodies in urine may be signs of too high blood sugar.
Danish: Tørst, øget vandladningstrang, træthed, tør hud, ansigtsrødme, tab af appetit, lavt blodtryk, hurtig hjerterytnme, og sukker og ketonstoffer i urinen kan være tegn på for højt blodsukker.
English: The time to peak insulin concentration (Tmax) is generally half of that for subcutaneously administered fast-acting human insulin.
Danish: Maksimal insulinkoncentration (Tmax) nås generelt på den halve tid i forhold til subkutant administreret hurtigtvirkende humant insulin.
English: If you accidentally expose your inhaler to moist conditions during use, this will usually decrease the dose of insulin you take.
Danish: Hvis De ved et uheld udsætter Deres inhalator for fugtige omgivelser under anvendelse, vil dette sædvanligvis nedsætte den mængde insulin De får.
English: A decline from baseline in FEV1 of > 15% occurred in 1.3% of EXUBERA-treated type 1 subjects and in 5.0% of EXUBERA-treated type 2 subjects.
Danish: Et fald i forhold til baseline i FEV1 på ≥ 15% ses hos 1,3% af de EXUBERA-behandlede patienter med type 1 diabetes og hos 5,0% af de EXUBERA-behandlede type 2 diabetikere.
English: a) The need for consistent and standard inhalation technique to ensure both optimal and consistent b) Special precaution with the insulin inhaler d) 1 mg and 3 mg dose inequivalence e) Magnitude of titration steps and resulting precautions f) The change in pulmonary function and the need for pulmonary function monitoring g) Smoking in relation to induced alteration in pharmacokinetics i) Increased insulin antibody levels j) Recommendation for special populations; underlying lung diseases such as asthma and COPD,
Danish: Undervisningsmaterialet skal indeholde oplysninger, som har til hensigt både at minimere bivirkninger og at sikre effektiv anvendelse af lægemidlet ved at give tilstrækkelige informationer om: a) Nødvendigheden af en ensartet og standard inhalationsteknik for at sikre både optimal og b) Særlige forholdsregler ved brugen af insulininhalatoren d) Manglende ækvivalens mellem en dosis på 1 mg og på 3 mg e) Dosistitrering og tilhørende forsigtighedssregler f) Ændringer i lungefunktionen og behov for at kontrollere lungefunktionen g) Rygnings inducerende påvirkning af farmakokinetikken j) Anbefalinger for særlige grupper; underliggende lungesygdomme som f.eks. astma og KOL, kronisk hjerteinsufficiens, graviditet, børn og unge
English: In subjects with type 1 or type 2 diabetes, inhaled human insulin has a faster onset of glucose lowering effect in the early hours after dosing when compared with subcutaneously administered fast
Danish: Hos forsøgspersoner med type 1 eller type 2 diabetes har inhaleret humant insulin en hurtigere indsættende glucosesænkende virkning i de første timer efter dosering sammenlignet med subkutant indgivet hurtigtvirkende humant insulin.
English: Substances that may enhance the blood-glucose lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic agents, angiotensin converting enzyme (ACE) inhibitors, monoamino oxidase (MAO) inhibitors, non-selective beta-blocking agents, salicylates and sulphonamide antibiotics.
Danish: Stoffer, som kan forstærke den blodsukkersænkende virkning og som kan øge risikoen for hypoglykæmi omfatter orale antidiabetika, angiotensin konverterende enzym (ACE) hæmmere, monoaminoxidase (MAO) hæmmere, non-selektive betablokkere, salicylater og sulfonamidantibiotika.
English: For the 1 mg product, the spine of the blister card has one raised ridge with the individual blisters embossed with one raised dot each.
Danish: På bagsiden af 1 mg blisterkortet er der en hævet rille, og de enkelte blistere er præget med en hævet prik hver.
English: Other reactions
Danish: Overfølsomhedsreaktioner
English: These symptoms often develop before the symptoms
Danish: Disse symptomer går ofte forud for symptomerne på lavt blodsukker i hjernen.
English: Then eat something that has a long-acting effect in raising your blood sugar (e.g. bread).
Danish: Spis herefter madvarer med langsomt optagelige kulhydrater (f.eks brød) for at normalisere Deres blodsukker.
English: Pfizer Manufacturing Frankfurt GmbH & Co. KG Industry Park Hoechst
Danish: KG Industry Park Hoeschst
English: A consistent and standard inhalation technique should be employed to ensure both optimal and consistent drug
Danish: Patienten skal derefter holde vejret i 5 sekunder og derefter puste ud på normal vis. En ensartet og standard inhalationsteknik skal anvendes for at sikre både optimal og
English: Comparator N= 253, 238, 252, 248,
Danish: Sammenligningsprodukt N=253, 238, 252, 248, 252, 249, 230, 224, 216, 253.
English: Administration of fluticasone prior to EXUBERA does not appear to affect insulin absorption (see section 5.2).
Danish: Administration af fluticason før EXUBERA har ingen virkning på EXUBERAs insulinabsorption (se
English: If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet.
Danish: Hvis De ammer, skal De kontakte lægen, da det kan være nødvendigt at justere Deres insulindosis og
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each unit dose blister contains 1 mg insulin human.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver enkeltdosisblister indeholder 1 mg humant insulin.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each unit dose blister contains 3 mg insulin human.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver enkeltdosisblister indeholder 3 mg humant insulin.
English: EXUBERA - Centrul de Rela)ii cu Clien)ii Tel.: 0800 390 000
Danish: EXUBERA - Centrul de Relaţii cu Clienţii Tel.: 0800 390 000
English: A decline from baseline in FEV1 of > 15% occurred in 1.3% of EXUBERA-treated and 1.0% of comparator-treated type 1 subjects and in 5.0% of EXUBERA-treated and 3.4% of comparator-treated
Danish: Et fald i forhold til baseline i FEV1 på ≥ 15% ses hos 1,3% af de EXUBERA-behandlede patienter og hos 1,0% af de sammenligningsprodukt-behandlede type 1 diabetikere og hos 5,0% af de EXUBERAbehandlede og hos 3,4% af de sammenligningsprodukt-behandlede type 2 diabetikere.
English: EXUBERA should only be breathed in through your mouth and should only be taken with your
Danish: EXUBERA må kun inhaleres gennem munden, og må kun tages ved hjælp af insulininhalatoren.
English: In clinical trials in type 1 diabetes, patients using a regimen of EXUBERA in combination with longor intermediate-acting insulin had similar reductions in HbA1c compared with patients taking subcutaneous insulin alone.
Danish: I kliniske forsøg på type 1 diabetes har patienter, der er i EXUBERA-behandling i kombination med langtids- eller middellangtidsvirkende insulin, et lignende fald i HbA1c som patienter, der tager subkutant insulin alene.
English: Respiratory,
Danish: 4.4 Respiratorisk).
English: Epistaxis Bronchospasm Wheezing Dysphonia Pharyngolaryngeal Pain Tonsillar Disorder Dry Mouth
Danish: Bronkospasme Hvæsende vejrtrækning Dysfoni
English: oC. Store in the original package in order to protect from moisture.
Danish: Opbevares under 30° C. Opbevares i den originale yderpakning for at beskytte mod fugt.
English: For the 3 mg product, the spine of the blister card has three raised ridges with the individual blisters embossed with three raised dots each.
Danish: På bagsiden af 3 mg blisterkortet er der 3 hævede riller, og de enkelte blistere er præget med 3 prikker hver.
English: Information on Clinical Trials
Danish: Gastrointestinale sygdomme
English: Alcohol may intensify and prolong
Danish: Alkohol kan intensivere og forlænge den hypoglykæmiske effekt af insulin.
English: If the washed chamber is not dry prior to taking your next dose, use your spare chamber.
Danish: Sørg for at der ikke er kammeret tilbage i hoveddelen, finder De i punktet Hvis det vaskede kammer ikke er tørt, før De tager
English: Fasting plasma glucose was similar to or lower in patients using a regimen including EXUBERA compared to patients treated with oral agents alone.
Danish: Fastende plasmaglucose er enten lig med eller lavere hos patienter, der behandles med EXUBERA sammenlignet med patienter, der udelukkende behandles med orale præparater.
English: Keep this leaflet.
Danish: Gem denne brugsanvisning.
English: Consecutive inhalation of three 1 mg unit dose blisters causes a significantly higher insulin exposure than inhalation of one 3 mg unit dose blister.
Danish: Inhalation af 3 konsekutive enkeltdosisblistere à 1 mg giver betydelig højere insulineksponering end inhalation af 1 enkeltdosisblister à 3 mg.
English: In subjects with type 1 diabetes mellitus, inhaled human insulin had a comparable intrasubject variability of AUC to subcutaneously administered fast-acting human insulin.
Danish: Hos forsøgspersoner med type 1 diabetes mellitus var den intraindividuelle variation i AUC for inhaleret humant insulin sammenlignelig med subkutant administreret hurtigtvirkende humant insulin.
English: Fasting plasma glucose levels were significantly lower in patients treated with EXUBERA regimens compared with those treated with subcutaneous insulin.
Danish: Fastende plasmaglucoseniveauer er signifikant lavere hos patienter, der behandles med EXUBERA end hos dem, der behandles med subkutant insulin.
English: Bioavailability of inhaled human insulin relative to subcutaneously administered fast-acting human insulin was comparable to that of adult subjects with type 1 diabetes (see section 4.2).
Danish: Biotilgængeligheden af inhaleret humant insulin i forhold til subkutant administreret hurtigtvirkende humant insulin er sammenlignelig med biotilgængeligheden hos voksne forsøgspersoner med type 1 diabetes (se pkt.
English: Do not substitute three 1 mg blisters for one 3 mg blister.
Danish: 1 blister à 3 mg må ikke erstattes med 3 blistere à 1 mg.
English: In this case you must change the Insulin Release Unit (IRU) prior to your
Danish: I sådanne tilfælde skal De udskifte insulinfrigivelsesenheden inden Deres næste inhalation.
English: Read all of this leaflet carefully before starting to use your insulin inhaler
Danish: Læs denne brugsanvisning godt igennem, før insulininhalatoren tages i brug.