FrancophonIA/ELRC3.0 huggingface dataset:
English: EXUBERA is not recommended for patients with lung disease.
Danish: EXUBERA anbefales ikke til patienter med lungesygdomme.
English: In clinical trials of Exubera, there have been 6 newly diagnosed cases of primary lung malignancies among Exubera-treated patients, and 1 newly diagnosed case among comparator treated patients.
Danish: I kliniske forsøg med EXUBERA er der diagnosticeret 6 nye tilfælde af primær lungemalignitet blandt patienter behandlet med EXUBERA, og 1 nyt tilfælde blandt patienter behandlet med sammenligningsprodukt.
English: Adjustments in drug dosage, meal patterns, or exercise may be needed.
Danish: Dosisjustering, ændring i kostplaner eller fysisk aktivitet kan være nødvendig.
English: You should change the IRU in your insulin inhaler every 2 weeks.
Danish: De bør udskifte insulinfrigivelsesenheden i Deres insulininhalator hver 2. uge.
English: Quickly form a seal with your lips around the mouthpiece so the insulin will not leak out.
Danish: Sæt læberne tæt om mundstykket, så insulinen ikke siver ud.
English: Observed Change from Baseline in FEV1 (L) in patients with type 1 diabetes mellitus.
Danish: Observeret ændring fra baseline i FEV1 (l) hos patienter med type 1 diabetes mellitus.
English: During intercurrent respiratory illness close monitoring of blood glucose concentrations and dose adjustment may be required on an individual basis (see section 4.2).
Danish: Under interkurrent luftvejssygdom kan tæt kontrol af blodsukker og dosisjustering være nødvendig på individuel basis (se pkt.
English: In clinical trials small but consistent treatment group differences in decline of pulmonary function (particularly Forced Expiratory Volume in one second (FEV1)) favouring comparator treated subjects have been observed.
Danish: I kliniske forsøg er der set små men konstante forskelle i fald i lungefunktionen (især Forced Expiratory Volume i et sekund (FEV1)) imellem behandlingsgrupperne med en lille fordel til patienter behandlet med sammenligningsprodukt.
English: The contents of the blisters should be breathed in through your mouth into your lungs using the insulin inhaler.
Danish: Indholdet i en blister skal suges ind gennem munden og ned i lungerne ved hjælp af insulininhalatoren.
English: Breast-feeding women may require adjustments in insulin dose and diet.
Danish: Ammende kvinder kan have behov for at justere insulindosis og diæt.
English: The use of a bronchodilator (reliever inhaler) for asthma or other airway conditions may cause a more pronounced fall in blood sugar in response to inhaled insulin (see section 2 “Do not take EXUBERA” and section 2 “Take special care with EXUBERA”).
Danish: Brug af bronkodilator (inhalationsbehandling) ved astma eller andre luftvejssygdomme kan føre til mere udtalt fald i blodsukkeret efter indtagelse af inhaleret insulin (se afsnit 2 ”De bør ikke tage EXUBERA” og afsnit 2 ” Vær særlig forsigtig med at anvende EXUBERA”).
English: After opening the foil overwrap: Store below 25˚C.
Danish: Efter åbning af folieovertrækket: Opbevares under 25°C.
English: EXUBERA has been administered to patients with intercurrent respiratory illness (e.g. bronchitis, upper respiratory tract infections) during clinical trials.
Danish: EXUBERA er i kliniske forsøg blevet givet til patienter med interkurrent luftvejssygdom (f.eks. bronkitis, øvre luftvejsinfektioner).
English: Hold the insulin inhaler in your hand.
Danish: Hold insulininhalatoren i hånden.
English: Bronchospasm may rarely occur.
Danish: Bronkospasme kan forekomme i sjældne tilfælde.
English: Observed Change from Baseline in FEV1 (L) in patients with type 2 diabetes mellitus.
Danish: Observeret ændring fra baseline i FEV1 (l) hos patienter med type 2 diabetes mellitus.
English: Table 1: Approximate Guidelines for Initial, Pre-Meal EXUBERA Dose (based on patient
Danish: Tabel 1: Vejledende guideline for initial EXUBERA-dosis før et måltid (udregnet efter
English: Therefore, EXUBERA should not be used during pregnancy.
Danish: EXUBERA bør derfor ikke anvendes under graviditet.
English: In most of these studies the percentages of patients achieving HbA1c < 7.0% were higher for patients using a regimen including EXUBERA compared to patients on oral agents alone.
Danish: I de fleste af disse forsøg er procentdelen af de patienter, der opnår HbA1c < 7,0 % højere for de patienter, der er i behandling med EXUBERA sammenlignet med patienter der udelukkende behandles med orale præparater.
English: If you have low body weight check with your doctor if you can use EXUBERA.
Danish: Hvis De har lav legemsvægt, skal De spørge lægen, om De kan anvende EXUBERA.
English: Insulin Blister
Danish: Insulinblister
English: There has also been 1 post-marketing report of a primary lung malignancy in an Exubera-treated patient.
Danish: Efter markedsføring er der også rapporteret om 1 tilfælde af primær lungemalignitet hos en patient behandlet med EXUBERA.
English: Administration of salbutamol 30 minutes prior to EXUBERA in non-diabetic subjects with mildmoderate asthma resulted in an increase in insulin AUC and Cmax of between 25 and 51% compared to when EXUBERA was administered alone (see sections 4.2 and 4.5).
Danish: Indgift af salbutamol 30 minutter før EXUBERA hos ikke-diabetikere med mild-moderat astma førte til en stigning i insulin AUC og Cmax på mellem 25-51% sammenlignet med EXUBERA indgivet alene (se pkt.
English: Controlled clinical trials in type 1 or type 2 diabetes have shown that EXUBERA achieves and maintains effective glycaemic control comparable to subcutaneously administered fast-acting human insulin.
Danish: Kontrollerede kliniske forsøg af type 1 eller type 2 diabetes viser, at EXUBERA opnår og fastholder effektiv glykæmisk kontrol sammenlignet med subkutant indgivet hurtigtvirkende humant insulin.
English: If you temporarily run out of 3 mg blisters, two 1 mg blisters should be used and you should monitor your blood glucose levels closely.
Danish: Hvis De midlertidigt løber tør for 3 mg blistere, skal De bruge 2 blistere à 1 mg og De skal nøje kontrollere Deres blodsukker.
English: The insulin inhaler should be replaced annually.
Danish: Insulininhalatoren bør udskiftes 1 gang årligt.
English: Hypoglycaemia may occur as a result of an excess of insulin relative to food intake, energy
Danish: Der kan forekomme hypoglykæmi som et resultat af et insulinoverskud i forbindelse med fødeindtagelse, energiforbrug eller begge dele.
English: Beta-blocking agents may mask the symptoms of hypoglycaemia.
Danish: Betablokkere kan maskere hypoglykæmiske symptomer.
English: Fast-acting Human Insulin (12 IU)
Danish: Hurtigtvirkende insulin (12 IE)
English: In a smaller group (n=36) of mixed type 1 and 2 subjects treated with EXUBERA for > 36 months, cessation of therapy resulted in a mean FEV1 increase of 0.036L over the subsequent 6 months.
Danish: I en mindre gruppe (n = 36) af blandede type 1 og 2 diabetikere behandlet med EXUBERA i > 36 måneder førte ophør af behandling til en gennemsnitlig FEV1 stigning på 0,036 l over den
English: The following symptoms indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.
Danish: Symptomerne på lavt blodsukker i hjernen er: hovedpine, udtalt sultfornemmelse, kvalme, opkastning, træthed, søvnighed, søvnforstyrrelser, rastløshed, aggressiv adfærd, koncentrationsbesvær, nedsat reaktionsevne, depression, konfusion, taleforstyrrelser (til tider fuldstændig tab af talens brug), synsforstyrrelser, rysten, lammelser, prikkende og stikkende fornemmelse (paræstesi), følelsesløshed og prikken og stikken omkring munden, svimmelhed, manglende selvbeherskelse, ude af stand til at tage vare på sig selv, kramper, bevidsthedstab.
English: Please also read the “Instructions for Use” of the inhaler at the end of the package leaflet carefully before taking EXUBERA.
Danish: Læs brugsanvisningen for inhalatoren som findes i sidste del af denne indlægsseddel grundigt inden De tager EXUBERA.
English: As part of this plan, the Marketing Authorisation Holder will provide health care professionals with educational materials for healthcare professionals and patients that are aimed at risk minimisation and will support safe and effective use for the product by the patient.
Danish: Som led i denne plan skal indehaveren af markedsføringstilladelsen stille undervisningsmateriale beregnet til både sundhedspersonale og patienter til rådighed for sundhedspersonale.
English: When an EXUBERA treated patient becomes pregnant appropriate subcutaneous insulin should be substituted for inhaled insulin.
Danish: Når en patient i EXUBERA-behandling bliver gravid, bør inhaleret insulin erstattes med passende subkutant insulin.
English: There is no clinical experience with EXUBERA use in pregnancy.
Danish: Der er ingen klinisk erfaring med anvendelse af EXUBERA-behandling under graviditet.
English: In patients with hepatic or renal impairment insulin requirements may be diminished.
Danish: Hos patienter med nedsat lever- eller nyrefunktion kan insulinbehovet være mindsket.
English: Dispose of the used IRU safely according to local requirements or check with your healthcare professional.
Danish: Træk den brugte insulinfrigivelsesenhed op og ud henhold til de lokale krav eller tjek dette med
English: Inhaled human insulin is delivered by the pulmonary route.
Danish: Inhaleret humant insulin indtages via lungerne.
English: In patients with type 2 diabetes sufficiently controlled with oral agents the glycaemic control was not further improved by inhaled insulin.
Danish: Hos patienter med type 2 diabetes, der er velkontrollerede med orale antidiabetika, forbedres den glykæmiske kontrol ikke yderligere med inhaleret insulin.
English: Substances that may reduce the blood-glucose lowering effect include corticosteroids, danazol, oral contraceptives, thyroid hormones, growth hormone, sympathomimetic agents and thiazides.
Danish: Stoffer, som kan nedsætte den blodsukkersænkende effekt omfatter kortikosteroider, danazol, orale antikontraceptiva, thyreoideahormoner, væksthormoner, sympatomimetika og thiazider.
English: It is advisable to test your blood sugar immediately after taking glucose to check that you really have
Danish: Det anbefales, at blodsukkeret kontrolleres umiddelbart efter indtagelsen af sukker, for at se om De virkelig havde hypoglykæmi.
English: These changes are usually mild and go away with time.
Danish: Disse ændringer er normalt milde
English: Make sure that you can use the inhaler properly as this could affect the
Danish: Vær sikker på, at De kan anvende inhalatoren korrekt, da dette kan have indflydelse på, hvor meget insulin De inhalerer.
English: Store the insulin inhaler in a dry place at room temperature.
Danish: Opbevar insulininhalatoren på et tørt sted ved stuetemperatur.
English: - you have had diabetes for a long time - due to diabetes, you suffer from a certain type of nervous disease (autonomic neuropathy), - you have recently suffered hypoglycaemia (e.g. the day before) or if it develops slowly, - you have almost normal or, at least, greatly improved blood sugar levels, - you are taking or have taken certain other medicines (see section 2, “Taking other medicines”).
Danish: - De på grund af Deres diabetes lider af visse andre former for sygdomme i nervesystemet - De for nylig har haft hypoglykæmi (f.eks. dagen før), eller hvis tilstanden udvikles langsomt, - De har et næsten normalt eller i det mindste betydeligt forbedret blodsukker, - De tager eller har taget visse andre lægemidler (se punkt 2, "Indtagelse af andre
English: In a prospective exploratory 6 month study in subjects with type 1 diabetes, alterations in the glucose pharmacodynamics with inhaled human insulin were not observed.
Danish: I et prospektivt eksplorativt 6 måneders forsøg hos forsøgspersoner med type 1 diabetes ses ingen ændringer i glucosefarmakodynamikken med inhaleret humant insulin.
English: Do not use three 1 mg blisters in place of one 3 mg blister, as this will give you a much higher dose of insulin.
Danish: De må ikke tage 3 blistere à 1 mg i stedet for 1 blister à 3 mg, da dette vil give en meget højere dosis insulin.
English: In this case, the Insulin Release Unit (IRU) must be changed prior to the next inhalation (see section 4.4).
Danish: I dette tilfælde skal insulinfrigivelsesenheden skiftes inden den næste inhalation (se pkt.
English: The use of EXUBERA in patients requiring dose titrations of less than 1 mg is not recommended (see section
Danish: Brug af EXUBERA til patienter, som kræver dosistitrering på mindre end 1 mg anbefales ikke (se pkt.
English: Press the grey button and pull out the insulin
Danish: Pres den grå knap ind og tag insulinblisteren ud.
English: EXUBERA is available in 1 mg and 3 mg unit dose blisters which are for administration via the lungs by oral inhalation only with the insulin inhaler.
Danish: EXUBERA findes i 1 mg og 3 mg enkeltdosisblistere, som kun anvendes ved hjælp af insulininhalatoren som oral pulmonal inhalationsbehandling.
English: Hypoglycaemia (low blood sugar levels) are also more likely to occur if: - you have just begun insulin treatment or changed to another insulin preparation, - your blood sugar levels are almost normal or are unstable, - you suffer from severe kidney or liver disease, or some other disease such as hypothyroidism.
Danish: Der er også større risiko for udvikling af for hypoglykæmi (lavt blodsukker), hvis: - De netop har påbegyndt insulinbehandling eller har skiftet til et andet insulinpræparat, - Deres blodsukker er næsten normalt eller ustabilt, - De lider af en alvorlig nyre- eller leversygdom, eller af anden sygdom som f.eks. nedsat
English: Refraction abnormalities of the eye may occur upon initiation of insulin therapy.
Danish: Refraktionsanomalier i øjet kan forekomme ved initiering af insulinbehandling.
English: Symptoms that tell you that your blood sugar level is falling too much or too fast may be, for example: sweating, clammy skin, anxiety, fast heartbeat, high blood pressure, palpitations and irregular heartbeat, chest pain (angina pectoris).
Danish: Symptomer på, at Deres blodsukker falder for meget eller for hurtigt kan f.eks. være: svedtendens, klam hud, angst, hurtig puls, højt blodtryk, hjertebanken og uregelmæssig puls, brystsmerter (angina pectoris).
English: EXUBERA should not be taken during pregnancy.
Danish: EXUBERA bør ikke tages under graviditet.
English: Insulin Release Unit Chamber Release Button (not visible)
Danish: Insulinfrigivelsesenhed Kammerfrigivelsesknap (ikke synlig) Grå knap
English: Administration of salbutamol prior to EXUBERA may result in increased insulin absorption (see section 5.2).
Danish: Administration af salbutamol før EXUBERA kan give øget insulinabsorption (se pkt.
English: The Insulin Release Unit (IRU) should be replaced once every 2 weeks.
Danish: Insulinfrigivelsesenheden skal udskiftes hver 2. uge.
English: These injections may be justified even if it is not
Danish: Det er forsvarligt at give disse indsprøjtninger, også selv om det ikke er sikkert, at De har hypoglykæmi.
English: For any information about this medicine, please contact the local EXUBERA Customer Care Centre.
Danish: Hvis De vil have yderligere oplysninger om EXUBERA, skal De henvende Dem til det lokale EXUBERA kundecenter.
English: In a study in healthy subjects, systemic exposure (AUC and Cmax) of inhaled human insulin increased in an approximately dose proportional fashion from 1 mg to 6 mg when a maximum of two blisters from either strength or their combination was administered.
Danish: I et forsøg med raske forsøgspersoner øges systemisk eksponering (AUC og Cmax) af inhaleret humant insulin på en tilnærmelsesvis dosisproportional måde fra 1- 6 mg, når der maksimalt blev givet samlet 2 blistere af hver styrke eller i kombination.
English: Dose adjustment may be required based on the meal size and nutrient composition, time of day (higher insulin requirements in the morning), pre-meal blood glucose concentration, recent or
Danish: Dosisjusteringer kan være nødvendige baseret på måltidets størrelse og næringsmæssige sammensætning, tid på dagen (højere insulinbehov om morgenen), blodsukkerkoncentration før
English: Inhaled human insulin may be used alone or in combination with oral antidiabetic agents and/or long or intermediate acting subcutaneously administered insulins to optimise glycaemic control.
Danish: Inhaleret humant insulin kan anvendes alene eller i kombination med orale antidiabetika og/eller langtidsvirkende eller middellangtvirkende insuliner indgivet subkutant for at
English: In EXUBERA treated subjects 0.4% discontinued treatment due to dyspnoea.
Danish: 0,4 % af de forsøgspersoner, der var i EXUBERA-behandling seponerede behandlingen på grund af dyspnø.
English: Approximate guidelines for initial, pre-meal EXUBERA doses, based on patient body weight, are indicated in Table 1:
Danish: Vejledende guideline for initial EXUBERA-dosis før et måltid, udregnet efter legemsvægt, findes i tabel 1:
English: You should avoid taking EXUBERA in moist conditions e.g. a bathroom following a steamy shower as this will usually give you a lower insulin dose than you need (see “Instructions for Use” at the end
Danish: De bør undgå at tage EXUBERA i fugtige omgivelser, f.eks. i badeværelset efter et dampende brusebad, da det normalt vil give Dem en lavere dosis insulin, end De har behov for (se brugsanvisning som findes i sidste del af denne indlægsseddel for yderligere oplysninger).
English: In children (6-11 years) and adolescents (12-17 years) with type 1 diabetes, inhaled human insulin was absorbed more rapidly than fast-acting human insulin.
Danish: Inhaleret humant insulin absorberes hurtigere hos børn (6-11 år) og unge (12-17 år) med type 1 diabetes end hurtigtvirkende humant insulin.
English: INFORMATION IN BRAILLE EXUBERA 3 mg
Danish: INFORMATION I BRAILLE-SKRIFT EXUBERA 3 mg
English: Such reactions to insulin or to the other ingredients can cause skin reactions, severe swelling of skin or mucous membranes (angio-oedema), shortness of breath, a fall in blood pressure and may become life threatening.
Danish: Disse reaktioner på insulin eller de øvrige indholdsstoffer kan forårsage hudreaktioner, kraftig hævelse af huden eller slimhinderne (angioødem), kortåndethed, faldende blodtryk, og de kan være livstruende.
English: If the insulin inhaler is inadvertently exposed to extremely moist conditions during use this usually leads to a subsequent decreased insulin dose delivered from the inhaler.
Danish: Hvis insulininhalatoren uforvarende udsættes for ekstremt fugtige forhold under anvendelsen, fører dette sædvanligvis til en efterfølgende nedsættelse af den insulindosis, som afgives fra inhalatoren.
English: WHAT EXUBERA IS AND WHAT IT IS USED FOR EXUBERA is an inhalation powder contained in blisters.
Danish: EXUBERAS VIRKNING OG HVAD DE SKAL BRUGE DET TIL EXUBERA er et inhalationspulver i blister.
English: Small treatment group differences (favouring comparator) in change from baseline of 0.034L in type 1 and 0.039L in type 2 occurred after 2 years of therapy.
Danish: Små forskelle imellem behandlingsgrupperne (til fordel for sammenligningsproduktet) i ændring fra baseline på 0,034 l hos type 1 og 0,039 l hos type 2 diabetikere ses efter 2 års behandling.
English: For Cmax, the intrasubject variability of inhaled insulin is greater than that of subcutaneously administered fastacting human insulin.
Danish: For Cmax er den intraindividuelle variation af inhaleret insulin større end for subkutant administreret hurtigtvirkende humant insulin.
English: When EXUBERA was administered to healthy volunteers following 2-hours of passive exposure to cigarette smoke in a controlled experimental setting, insulin AUC and Cmax were reduced by approximately 17 and 30%, respectively (see section 4.5).
Danish: Når EXUBERA gives til raske frivillige forsøgspersoner, efter at de i et kontrolleret forsøgsmiljø har været udsat for passiv rygning fra cigaretter i 2 timer, nedsættes insulin AUC og Cmax med henholdsvis
English: It inhibits glycogenolysis and gluconeogenesis, increases lipogenesis in the liver and adipose tissue and inhibits lipolysis.
Danish: Insulin hæmmer glycogenolyse og gluconeogenese, øger lipogenesen i lever og fedtvæv samt hæmmer lipolysen.
English: For further information on hyperglycaemia, see the end of section 4 “Possible side effects”.
Danish: Yderligere oplysninger om hyperglykæmi findes sidst i punkt 4 ”Hvilke mulige bivirkninger EXUBERA har”.
English: There is no experience on the use of EXUBERA in pregnant women.
Danish: Der er ingen erfaring med behandling med EXUBERA til gravide kvinder.
English: EXUBERA 1 mg inhalation powder pre-dispensed EXUBERA 3 mg inhalation powder pre-dispensed
Danish: EXUBERA 1 mg afdelt inhalationspulver EXUBERA 3 mg afdelt inhalationspulver
English: In a study where the dosage form of three 1 mg blisters was compared with one 3 mg blister, Cmax and AUC of inhaling three 1 mg blisters were approximately 30% and 40% greater, respectively, than that of inhaling from one 3 mg blister, indicating that three 1 mg blisters are not interchangeable with one 3 mg blister (see sections 2, 4.2 and 4.4).
Danish: I et forsøg, hvor 3 blistere af lægemiddelformen 1 mg blister blev sammenlignet med 1 blister à 3 mg, var Cmax og AUC efter inhalation af 3 blistere à 1 mg henholdsvis ca. 30% og 40% højere end inhalation af 1 blister à 3 mg , hvilket viser, at 3 blistere à 1 mg ikke kan erstattes af 1 blister à 3 mg (se pkt.
English: Washout Phase
Danish: Udvaskningsfase
English: (Seen in less than 1 in 100 but more than 1 in 1000 patients).
Danish: Bivirkninger, som er rapporteret som ikke almindelige (ses hos mindre end 1 ud af 100, men hos mere end 1 ud af 1000 patienter)
English: Each unit dose blister contains 1 mg or 3 mg of the active substance insulin human.
Danish: Hver enkeltdosisblister indeholder 1 mg eller 3 mg af det aktive stof humant insulin.
English: Uncommon side effects are inflammation of the throat (pharyngitis), nose bleed (epistaxis), airway constriction with difficulties breathing (bronchospasm), wheezing, voice alteration (dysphonia), throat pain (pharyngolaryngeal pain), tonsillar disorder, dry mouth and chest pain.
Danish: Ikke almindelige bivirkninger er infektion i halsen (pharyngitis), næseblod (epistaxis), luftvejsindsnævring og besvær med at trække vejret (bronkospasme), hvæsende vejrtrækning, stemmeændring (dysfoni), smerter i halsen (pharyngolaryngeale smerter), problemer med mandlerne,
English: In non-diabetic subjects with mild to moderate asthma, AUC and Cmax for inhaled human insulin in the absence of treatment with a bronchodilator was slightly less than in subjects without asthma.
Danish: Hos ikke-diabetikere med mild til moderat astma, der ikke er i behandling med bronkodilatorer, er AUC og Cmax af inhaleret humant insulin lidt lavere end hos forsøgspersoner, der ikke har astma.
English: Small treatment group differences in decline of FEV1 were observed in the EXUBERA group relative to comparator therapy.
Danish: Små forskelle i faldet i FEV1 imellem behandlingsgrupperne ses i gruppen behandlet med EXUBERA i sammenligning med sammenligningsprodukt-behandling.
English: The mouthpiece should now
Danish: Mundstykket skal nu vende ind
English: Do not store the insulin inhaler in the refrigerator or freezer.
Danish: Insulininhalatoren må ikke opbevares i køleskab eller nedfryses.
English: Development of such antibodies is seen more commonly in patients treated with EXUBERA compared to subcutaneous insulin.
Danish: Dannelse af disse antistoffer ses hyppigere hos patienter, der behandles med EXUBERA sammenlignet med subkutant insulin.
English: Additional insulin inhaler, insulin release units and chamber packages are available.
Danish: Yderligere pakninger med insulininhalatorer, insulinfrigivelsesenheder og reservekamre er
English: Do not take EXUBERA
Danish: Tag ikke EXUBERA: