FrancophonIA/ELRC3.0 huggingface dataset:
English: Always make sure you have the correct strength and number of EXUBERA blisters available before taking your dose.
Danish: De skal altid sikre Dem, at De har den korrekte styrke og korrekt antal blistere, inden De tager Deres dosis.
English: Caution: please remember that artificial sweeteners and foods with artificial sweeteners (e.g. diet drinks) are of no help in hypoglycaemia.
Danish: NB: Husk at kunstige sødemidler og madvarer indeholdende kunstige sødemidler (f.eks. light sodavand) ikke kan anvendes til behandling af hypoglykæmi.
English: If your liver or kidneys do not function well speak to your doctor, who may advise that you use lower insulin doses.
Danish: Hvis Deres lever eller nyrer ikke fungerer normalt, skal De tale med lægen, som måske vil råde Dem til at tage en mindre dosis insulin.
English: Patients should inhale the insulin powder from the mouthpiece in one slow and steady inhalation.
Danish: Patienten skal inhalere insulinpulveret gennem mundstykket i én langsom og ensartet inhalation.
English: If you are ill or have a major injury, then your blood sugar may increase (hyperglycaemia) or if you are not eating enough your blood sugar may become too low (hypoglycaemia).
Danish: Hvis De er syg eller kommer alvorligt til skade, kan Deres blodsukker stige (hyperglykæmi), eller hvis De ikke spiser nok, kan Deres blodsukker blive for lavt (hypoglykæmi).
English: A follow-up lung function measurement is recommended after the first 6 months of therapy.
Danish: En opfølgningsundersøgelse af lungefunktionen efter de første 6 måneder af behandlingen er anbefalet.
English: Before taking a medicine ask your doctor if it can affect your blood sugar level, and what action, if any, you need to take.
Danish: Før De begynder at tage et lægemiddel, skal De spørge lægen, om det kan påvirke blodsukkeret, og hvilke forholdsregler De eventuelt skal tage.
English: Inhaled insulin frequently induces insulin antibodies, the risk of which to the foetus is not known.
Danish: Inhaleret insulin fremkalder hyppigt insulinantistoffer, hvoraf risikoen for fosteret er ukendt.
English: Long-term safety of inhaled human insulin has not been established in paediatric patients with diabetes and its use is therefore not recommended in patients under 18 years of age (see section 5.2).
Danish: Langtidssikkerheden af inhaleret humant insulin er ikke undersøgt hos pædiatriske patienter med diabetes, og anvendelse til patienter under 18 år anbefales derfor ikke (se pkt.
English: The table below contains adverse reactions seen in controlled clinical studies including more than 1970 patients exposed to EXUBERA.
Danish: Tabellen nedenfor viser de mulige bivirkninger, som er set i kontrollerede kliniske forsøg med deltagelse af mere end 1970 patienter behandlet med EXUBERA.
English: Speak to a doctor immediately if you are not able to control the hypoglycaemia or if it recurs.
Danish: Søg omgående læge, hvis De ikke kan få kontrol over Deres hypoglykæmi, eller hvis tilstanden kommer igen.
English: Severe (GOLD stage III or IV) Chronic obstructive pulmonary disease (COPD).
Danish: Alvorlig (GOLD stadie III eller IV) Kronisk Obstruktiv Lungesygdom (KOL).
English: Please talk to your doctor if you have problems administering EXUBERA or controlling your blood glucose.
Danish: Tal med Deres læge, hvis De får problemer med at tage EXUBERA eller får problemer med at kontrollere Deres blodsukker.
English: The first symptoms which alert you to hypoglycaemia (“warning symptoms”) may change, be weaker
Danish: De første symptomer på, at der er ved at opstå hypoglykæmi ("advarselssymptomer"), kan ændre
English: It is important that you take the number of 1 mg and 3 mg blisters that your doctor recommends in the combination that he or she recommends.
Danish: Det er vigtigt, at De tager det antal 1 mg og 3 mg blistere, som lægen har foreskrevet og i den
English: These subjects experienced an average decrease in FEV1 of 21% (range 16%-33%) from baseline and were treated with EXUBERA for an average of 23 months.
Danish: Disse patienter oplevede et gennemsnitligt fald i FEV1 på 21% (varierende fra 16-33%) i forhold til baseline, og de blev behandlet med EXUBERA i gennemsnitlig 23 måneder.
English: Push the blue button until it clicks and watch for the insulin cloud to appear in the chamber.
Danish: Tryk på den blå knap, indtil der kommer et klik og afvent, at insulinskyen kan ses i
English: Peak insulin concentration is reached generally by 45 minutes for inhaled human insulin.
Danish: Maksimal insulinkoncentration nås generelt efter 45 minutter ved inhaleret humant insulin.
English: Hypoglycaemia, in general the most frequent undesirable effect of insulin therapy including EXUBERA and many oral antidiabetic agents, may occur if the insulin dose is too high in relation to the insulin requirement.
Danish: Hypoglykæmi, som generelt er den hyppigst forekommende bivirkning ved insulinbehandling inklusiv EXUBERA og mange orale antidiabetika, kan forekomme, hvis insulindosis er for høj i forhold til insulinbehovet.
English: Alcohol may increase the action of insulin and cause low blood sugar levels.
Danish: Alkohol kan øge insulinvirkningen og kan give lavt blodsukker.
English: The relative bioavailability of EXUBERA compared to subcutaneous fast-acting human insulin is approximately 10%.
Danish: Den relative biotilgængelighed af EXUBERA sammenlignet med subkutant hurtigtvirkende humant insulin er ca. 10%.
English: -If you have missed a dose of insulin or if you have taken too low a dose, your blood sugar level may become too high.
Danish: - Hvis De har sprunget en dosis insulin over eller har taget for lille en dosis, kan blodsukkeret blive for højt.
English: Use of inhaled human insulin is associated with an increase in frequency, and levels of insulin antibodies.
Danish: Brug af inhaleret humant insulin er forbundet med en stigning i hyppighed og mængde af insulinantistoffer.
English: A small decrease in your lung function may occur during EXUBERA treatment, although you should not notice any symptoms.
Danish: En mindre nedsættelse af lungefunktionen kan optræde under behandling med EXUBERA, selv om De ikke burde kunne mærke nogen symptomer.
English: Inadequate dosage or discontinuation of treatment especially in insulin-dependant diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.
Danish: Utilstrækkelig dosering eller seponering af behandling specielt hos insulinkrævende diabetikere kan føre til hyperglykæmi og diabetisk ketoacidose, som kan medføre død.
English: Squeeze the handle until it snaps shut.
Danish: Klem på håndtaget indtil det lukkes med et smæld.
English: Both EXUBERA and comparator treated subjects experienced declines in lung function over time during these trials (Figures 2 and 3).
Danish: Både EXUBERA- og sammenligningsprodukt-behandlede forsøgspersoner oplevede fald i lungefunktionen over tid under disse kliniske forsøg (Fig. 2 og 3).
English: To use an EXUBERA blister, first separate the blister from the spine by tearing along the tear line
Danish: For at anvende en EXUBERA blister skal De først dele blisterne fra bagsiden ved at rive langs linjen
English: Hypoglycaemia - As with all insulin therapy, the most common side effect with EXUBERA is hypoglycaemia (too low blood sugar).
Danish: Hypoglykæmi - Som for al insulinbehandling er den hyppigste bivirkning med EXUBERA hypoglykæmi (for lavt blodsukker).
English: MINIMUM PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING FOIL OVERWRAP
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: Test your blood sugar level and your urine for ketones as soon as any such symptoms of hyperglycaemia occur as described above.
Danish: Kontrollér blodsukkeret og undersøg urinen for ketonstoffer, så snart en eller flere af de symptomer, som er beskrevet ovenfor, opstår.
English: Animal studies did not show that inhaled human insulin accumulates in the lung.
Danish: Dyreforsøg viser ikke, at inhaleret humant insulin ophobes i lungerne.
English: INH and INH washout N=158, 155, 143, 139, 123.
Danish: INH og INH udvaskning N=158, 155, 143, 139, 123.
English: EXUBERA is an inhalation powder, pre-dispensed, and is supplied as tear-off unit dose blisters marked with either ‘1 mg EXUBERA' with green ink or ‘3 mg EXUBERA' with blue ink.
Danish: EXUBERA er et afdelt inhalationspulver og leveres som afrivnings-enkeltdosisblistere mærket enten ”1 mg EXUBERA” med grønt blæk eller ”3 mg EXUBERA” med blåt blæk.
English: Oedema and refraction abnormalities of the eye
Danish: Ødem og refraktionsanomalier i øjet
English: A range of different chest symptoms were reported as treatment-related adverse reactions and were referred to as non-specific chest pain.
Danish: En række forskellige brystrelaterede symptomer ses som behandlingsrelaterede bivirkninger og blev karakteriseret som værende ikke-specifikke brystsmerter.
English: The majority (> 95%) of dyspnoea was reported as mild to moderate.
Danish: Størstedelen (> 95%) af de rapporterede dyspnøtilfælde var milde til moderate.
English: Do not open the blister containing EXUBERA.
Danish: De må ikke åbne blisteren med EXUBERA.
English: Some patients have experienced fluid in the lung lining (pleural effusion).
Danish: Nogle patienter har oplevet væske i lungerne (pleuraekssudat).
English: Insulin antibody levels were higher in patients with type 1 diabetes compared to type 2 diabetes and plateaued within 6-12 months of exposure in both groups.
Danish: Insulinantistof-niveauet var højere hos patienter med type 1 diabetes sammenlignet med patienter med type 2 diabetes, og et stabilt niveau blev opnået inden for 6-12 måneders eksponering for begge grupper.
English: The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at et fungerende bivirkningsovervågningssystem er implementeret, inden lægemidlet markedsføres.
English: Changes to your sight may occur upon starting insulin therapy.
Danish: Ændringer af synet kan opstå, når De starter på insulinbehandling.
English: The safety of EXUBERA alone, or in combination with subcutaneous insulin or oral agents has been evaluated in clinical studies of more than 2700 patients with type 1 or type 2 diabetes, including more than 1975 adults exposed for greater than 6 months and more than 745 adults for greater than 2 years.
Danish: Sikkerheden af EXUBERA-behandling alene eller i kombination med subkutant insulin eller orale lægemidler er evalueret i kliniske forsøg på mere end 2700 patienter med type 1 eller type 2 diabetes, inklusiv mere end 1975 voksne, der var i behandling i mere end 6 måneder, og mere end 745 voksne i
English: EXUBERA is used to reduce high blood sugar in adult patients with type 2 diabetes mellitus who
Danish: EXUBERA anvendes til at nedsætte for højt blodsukker hos voksne patienter med type 2 diabetes
English: The cough tended to occur within seconds to minutes after insulin inhalation and was predominantly mild in severity.
Danish: Hosten opstår generelt inden for sekunder til minutter efter insulininhalationen og er primært mild.
English: Number of 3 mg Blisters per Dose
Danish: Antal 3 mg blistere pr. dosis
English: Please speak to your doctor immediately if you take EXUBERA and resume smoking or have smoked in the last 6 months
Danish: Tal straks med lægen, hvis De tager EXUBERA, og begynder at ryge igen eller har røget inden for de sidste 6 måneder, før De starter med at tage EXUBERA.
English: In controlled clinical trials of Exubera, the incidence of new primary lung cancer per 100 patient-years of study drug exposure was 0.130 (5 cases over 3800 patient-years) for Exubera-treated patients and 0.03 (1 case over 3900 patient-years) for comparator-treated patients.
Danish: I kontrollerede kliniske forsøg med EXUBERA er hyppigheden af ny primær lungecancer pr. 100 patientår behandlet med forsøgsmedicin 0,130 (5 tilfælde på 3800 patientår) for EXUBERA-behandlede patienter og 0,03 (1 tilfælde på 3900 patientår) for patienter behandlet med sammenligningsprodukt.
English: More severe episodes, with coma, seizure, or neurological impairment may be treated with intramuscular/subcutaneous glucagon (0.5 to 1 mg) or concentrated intravenous glucose.
Danish: Sværere tilfælde med koma, kramper eller neurologisk svækkelse kan behandles med intramuskulær/subkutan glucagon (0,5-1 mg) eller koncentreret intravenøs glucoseopløsning.
English: Experience with inhaled insulin in patients with congestive heart failure is very limited and its use is therefore not recommended in such patients where lung function is significantly compromised.
Danish: Erfaring med inhaleret insulin til patienter med kronisk hjerteinsufficiens er begrænset, og anvendelse til patienter med signifikant kompromitteret lungefunktion anbefales derfor ikke.
English: Comparator N=145, 143, 125, 129, 120.
Danish: Sammenligningprodukt N=145, 143, 125, 129, 120.
English: Number of 1 mg Blisters per Dose
Danish: Antal 1 mg blistere pr. dosis
English: Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in
Danish: Efter at have genvundet bevidstheden, anbefales det at give patienten oral kulhydrat for at undgå
English: EXUBERA (inhaled human insulin) is a fast-acting human insulin for use in type 1 or type 2 diabetes.
Danish: EXUBERA (inhaleret humant insulin) er et hurtigtvirkende humant insulin til behandling af type 1 eller type 2 diabetes.
English: Always make sure you have the correct blisters available before using your insulin inhaler.
Danish: De skal altid sørge for at have det rigtige antal blistere tilgængeligt, før De bruger insulininhalatoren.
English: The blue dot on the bottom of the chamber must be on the same side as the blue button.
Danish: Den blå prik i bunden af kammeret skal hoveddelen ind samtidigt.
English: If you have infection in your airways (such as bronchitis or upper respiratory tract infection) while taking EXUBERA you should monitor your blood glucose frequently and you may need to adjust your EXUBERA dose.
Danish: Hvis De får infektion i luftvejene (f.eks. bronkitis eller øvre luftvejsinfektion), mens De tager EXUBERA, skal De kontrollere Deres blodsukker hyppigt, og det kan blive nødvendigt, at De justerer dosis af EXUBERA.
English: The concomitant use of bronchodilators such as salbutamol may increase the absorption of EXUBERA and may therefore increase the risk of hypoglycaemia when used to relieve acute respiratory symptoms (see section 4.5).
Danish: Samtidig brug af bronkodilatorer som f.eks. salbutamol kan øge absorptionen af EXUBERA og kan derfor øge risikoen for hypoglykæmi, hvis disse anvendes til at afhjælpe akutte luftvejssymptomer (se
English: - The other ingredients are: mannitol, glycine, sodium citrate (as dihydrate) and sodium hydroxide.
Danish: - Øvrige indholdsstoffer: mannitol, glycin, natriumcitrat (som dihydrat) og natriumhydroxid.
English: 6 of these discontinued subjects underwent follow-up pulmonary function testing.
Danish: 6 af de patienter, der afbrød behandlingen, gennemgik en opfølgende lungefunktionstest.
English: Where pulmonary oedema is present, or there is a clinically relevant reduction in pulmonary function, EXUBERA should be discontinued and the patient switched to injectable insulin.
Danish: I tilfælde af lungeødem, eller hvis der opstår klinisk relevant nedsat lungefunktion, bør EXUBERA seponeres, og patienten skiftes over til injicerbart insulin.
English: One blister card contains 6 perforated unit dose blisters (PVC/Aluminium).
Danish: 1 blisterkort indeholder 6 perforerede enkeltdosisblistere (PVC/aluminium).
English: Change from Baseline in FEV1 (L) ( Mean +/- SD)
Danish: Ændring i forhold til baseline i FEV1 (l) ( Mean +/- SD)
English: EXUBERA can also be used to treat type 1 diabetes in adults whose level of blood sugar is not wellcontrolled by insulin injections.
Danish: EXUBERA kan også anvendes til behandling af voksne med type 1 diabetes, hvis deres blodsukkerniveau ikke kan kontrolleres godt nok med insulininjektioner.
English: In such situations, the management of your diabetes may require a lot of care and you may need to seek advice from your
Danish: I sådanne situationer kan kontrollen af Deres diabetes kræve meget omhyggelig kontrol, og det kan blive nødvendigt, at De kontakter Deres læge eller diabetessygeplejerske.
English: Mild episodes of hypoglycaemia usually can be treated with oral carbohydrates.
Danish: Milde tilfælde af hypoglykæmi kan sædvanligvis behandles med oral indtagelse af kulhydrater.
English: One subject in the EXUBERA and one in the comparator group discontinued treatment due to chest pain.
Danish: Én forsøgsperson fra EXUBERA-gruppen og én fra sammenligningsproduktgruppen seponerede behandling på grund af brystsmerter.
English: Hold the insulin inhaler upright with the blue button facing towards you.
Danish: Hold insulininhalatoren lodret med den blå knap ind mod Dem selv.
English: Inhalation toxicity studies in rats and monkeys for up to 6 months gave no evidence for a special risk to the respiratory tract due to insulin inhalation powder.
Danish: Inhalationstoksicitetsforsøg på rotter og aber i op til 6 måneder viser ingen speciel risiko for luftrøret
English: If a patient starts or resumes smoking, EXUBERA must be discontinued immediately due to the increased risk of hypoglycaemia and an alternative treatment
Danish: Hvis en patient starter eller genoptager rygning, skal EXUBERA-behandling omgående afbrydes, da der vil være øget risiko for hypoglykæmi, og der skal herefter påbegyndes anden behandling (se pkt.
English: Also contains: Mannitol, glycine, sodium citrate (as dihydrate), sodium hydroxide
Danish: Indeholder også mannitol, glycin, natriumcitrat (som dihydrat) og natriumhydroxid
English: A unit dose blister is the individual container in which the insulin powder is packaged and will be called a blister in the rest of this leaflet.
Danish: En enkeltdosisblister er den beholder, som insulinpulveret er pakket i, og denne vil i resten af denne
English: EXUBERA is indicated for the treatment of adult patients with type 2 diabetes mellitus not adequately controlled with oral antidiabetic agents and requiring insulin therapy.
Danish: EXUBERA er indiceret til behandling af voksne patienter med type 2 diabetes mellitus, som ikke er tilstrækkelig kontrolleret på orale antidiabetika, og som kræver insulinbehandling.
English: 6.6 Special precautions for disposal and other handling EXUBERA unit dose blisters must only be used with the insulin inhaler.
Danish: 6.6 Regler for destruktion og anden håndtering EXUBERA enkeltdosisblistere må kun anvendes sammen med insulininhalatoren.
English: Insulin therapy may cause sodium retention and oedema.
Danish: Insulinbehandling kan give natriumretention og ødem.
English: Patients started on EXUBERA must receive comprehensive instructions in the use of the inhaler (see IFU).
Danish: Patienter, der skal starte på behandling med EXUBERA, skal have grundig anvisning i brugen af inhalatoren (se brugsanvisningen).
English: Administration of EXUBERA 10 minutes prior to administration of salbutamol did not affect the bronchodilatory response to salbutamol in non-diabetic subjects with mild-moderate asthma.
Danish: Indgift af EXUBERA 10 minutter før indgift af salbutamol påvirkede ikke det bronkodilatoriske respons af salbutamol hos ikke-diabetikere med mild-moderat astma.
English: In patients with a confirmed (i.e. at least two consecutive tests, 3 to 4 weeks apart) FEV1 decline of > 20% from baseline, EXUBERA therapy should be discontinued and the patient monitored as clinically indicated.
Danish: Hos patienter med et bekræftet (dvs. mindst 2 på hinanden følgende tests, foretaget med 3-4 ugers mellemrum) fald i FEV1 på >20% i forhold til baseline , bør behandling med EXUBERA seponeres, og patienten skal monitoreres som klinisk indiceret.
English: If you need dose titrations of less than 1 mg it is recommended you do not use EXUBERA (see section 3 “How to take EXUBERA” for further advice and section 6 “Further information”).
Danish: Hvis De har brug for en dosis på mindre end 1 mg, anbefales det ikke at anvende EXUBERA (se yderligere informationer i afsnit 3 ”Hvordan De tager EXUBERA” og afsnit 6 ”Yderligere oplysninger”).
English: EXUBERA is also indicated for the treatment of adult patients with type 1 diabetes mellitus, in addition to long or intermediate acting subcutaneous insulin, for whom the potential benefits of adding inhaled insulin outweigh the potential safety concerns (see section 4.4).
Danish: EXUBERA er også indiceret til behandling af voksne patienter med type 1 diabetes mellitus i tillæg til langtidsvirkende eller middellangtvirkende subkutant insulin, hvis den mulige fordel ved tillæg af inhaleret insulin opvejer de mulige sikkerhedsaspekter (se pkt.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS {ART/TYPE}
English: There is very little experience with EXUBERA in patients with congestive heart failure.
Danish: Der er kun lidt erfaring med behandling af patienter med kronisk hjerteinsufficiens.
English: Human insulin lowers blood glucose and promotes anabolic effects as well as decreasing catabolic effects, increases the transport of glucose into cells as well as the formation of glycogen in the muscles and the liver, and improves pyruvate utilisation.
Danish: Humant insulin sænker blodsukkeret og fremskynder den anabolske effekt og mindsker ligeledes den katabolske effekt, fremmer transporten af glucose til cellerne og dannelsen af glycogen til muskler og lever, og forbedrer udnyttelsen af pyruvat.
English: Insulin human
Danish: Insulin, humant
English: If at 6 months a decline of 15-20% or > 500ml from baseline lung function is observed, spirometry should be repeated after 3 months.
Danish: Hvis der efter 6 måneder ses et fald på 15-20% eller >500 ml i forhold til baseline lungefunktion, bør spirometri gentages efter 3 måneder.
English: Your blood sugar levels may fall too much, if for example: - you take too much insulin, - you miss meals or delay them, - you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates), - you lose or are unable to consume carbohydrates due to vomiting or diarrhoea, - you drink alcohol, particularly if you are not eating much, - you take more physical exercise than usual or a different type of physical activity, - you are recovering from an injury or operation or other stress, - you are recovering from a feverish illness or from another illness, - you are taking or have stopped taking certain other medicines (see section 2, “Taking other
Danish: Blodsukkeret kan blive for lavt, hvis De f.eks.: - Tager for meget insulin, - springer måltider over eller udsætter dem, - ikke spiser nok eller spiser mad, der indeholder færre kulhydrater end normalt (sukker og sukkerlignende stoffer kaldes kulhydrater; mens kunstige sødemidler IKKE er kulhydrater), - mister kulhydrater på grund af opkastning og diarré, - drikker alkohol, især hvis De ikke spiser ret meget, - får mere motion end normalt eller er udsat for en anden form for fysisk aktivitet, - er ved at komme Dem efter en læsion eller operation eller andre former for stress, - er ved at komme Dem efter en febersygdom eller anden sygdom, - tager eller er holdt op med at tage visse andre lægemidler (se punkt 2, "Indtagelse af andre
English: An explanation for the differences in bioavailability appears to be the different energy to mass ratio between the 1 and 3 mg unit blisters since with less powder in the blister the inhaler is more efficient in breaking up or de-agglomerating the powder leading to a larger proportion of smaller aerodynamic particle sizes for the 1 mg blister
Danish: En forklaring på forskellen i biotilgængeligheden synes at være energiforskellen i masseratio mellem blistere à 1 og 3 mg. Jo mindre pulver i blisteren, jo mere effektivt kan inhalatoren opdele eller de-agglomerere pulveret, hvilket fører til en større andel af mindre, aerodynamiske partikelstørrelser for blistere à 1 mg (se pkt.