natgillin/translations-raw huggingface dataset:
al Hosten opstår generelt inden for sekunder til minutter efter insulininhalationen og er primært mild.
The cough tended to occur within seconds to minutes after insulin inhalation and was predominantly od
s Hosten aftager over tid.
This cough decreased over time.
1% af patienterne seponerede EXUBERA- behandling på grund af hoste.
One percent of patients discontinued EXUBERA treatment due to cough. pr
Dyspnø
Dyspnoea al
et Størstedelen (> 95%) af de rapporterede dyspnøtilfælde var milde til moderate.
The majority (> 95%) of dyspnoea was reported as mild to moderate.
0, 4% af de
In EXUBERA treated subjects in
er forsøgspersoner, der var i EXUBERA- behandling seponerede behandlingen på grund af dyspnø.
0.4% discontinued treatment due to dyspnoea. ic
ris Brystsmerter
Chest pain ed
to En række forskellige brystrelaterede symptomer ses som behandlingsrelaterede bivirkninger og blev karakteriseret som værende ikke- specifikke brystsmerter.
A range of different chest symptoms were reported as treatment-related adverse reactions and were referred to as non-specific chest pain..
Størstedelen (> 95%) af disse bivirkninger au var milde til moderate.
The majority (> 95%) of these events was reported as mild to M
Én forsøgsperson fra EXUBERA- gruppen og én fra sammenligningsprodukt - gruppen seponerede behandling på grund af brystsmerter.
One subject in the EXUBERA and one in the comparator group discontinued treatment due to chest pain.
Det er væsentligt, at forekomsten af e bivirkninger af alle årsager, der var relateret til koronararteriesygdom, såsom angina pectoris eller myokardieinfarkt, ikke øges ved brug af EXUBERA. er ng
Importantly, the incidence of all-causality adverse events related to coronary artery disease, such as angina pectoris or myocardial infarction was not increased with the use of EXUBERA.
Andre bivirkninger
24 Other reactions
Små forskelle i faldet i FEV1 imellem behandlingsgrupperne ses i gruppen behandlet med EXUBERA e
Small treatment group differences in decline of FEV1 were observed in the EXUBERA group relative to comparator therapy.
I kliniske forsøg på op til 2 år ses ikke kk
In clinical studies of up to two years duration, there was no accelerated decline beyond 3-6 months.
4. 4 og 5. 1). i er
Discontinuation of EXUBERA therapy after 2 years resulted in resolution of treatment group differences within 6 weeks (see sections 4.4 and 5.1).
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. t le
A decline from baseline in FEV1 of > 15% occurred in 1.3% of EXUBERA-treated type 1 subjects
Insulinantistoffer id
Insulin antibodies
I kliniske m
In clinical
forsøgspersoner, der forblev i behandling med subkutant humant insulin.
ho 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.
Insulinantistof- niveauet var højere hos patienter med type 1 diabetes sammenlignet med patienter med type 2 diabetes, og et stabilt Læ
Insulin antibody levels were higher in patients with type 1
niveau blev opnået inden for 6- 12 måneders eksponering for begge grupper.
ut diabetes compared to type 2 diabetes and plateaued within 6-12 months of exposure in both groups.
Der er ikke identificeret nogen klinisk betydning af disse antistoffer.
ra No clinical significance of these antibodies has been identified.
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.
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). lo
4. 4 Respiratorisk).
Oedema and refraction abnormalities of the eye o tn
23 Ødem og refraktionsanomalier i øjet Insulinbehandling kan give natriumretention og ødem.
Insulin therapy may cause sodium retention and oedema.
g Milde tilfælde af hypoglykæmi kan sædvanligvis behandles med oral indtagelse af kulhydrater.
Mild episodes of hypoglycaemia usually can be treated with oral carbohydrates.
al Dosisjustering, ændring i kostplaner eller fysisk aktivitet kan være nødvendig.
Adjustments in drug dosage, meal patterns, or exercise may be needed. al
s Sværere tilfælde med koma, kramper eller neurologisk svækkelse kan behandles med
More severe episodes, with coma, seizure, or neurological impairment may be treated with in
il intramuskulær/ subkutan glucagon (0, 5 - 1 mg) eller koncentreret intravenøs glucoseopløsning.
Glucose ic
t Glucoseopløsning skal også gives intravenøst, hvis patienten ikke responderer på glucagon inden for
must also be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes. ed
er Efter at have genvundet bevidstheden, anbefales det at give patienten oral kulhydrat for at undgå tilbagefald.
Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
ris to
M
A10AF01. er
A10AF01
Virkningsmekanisme ng
25 Mode of Action
katabolske effekt, fremmer transporten af glucose til cellerne og dannelsen af glycogen til muskler og lever, og forbedrer udnyttelsen af pyruvat.
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.
Humant insulin fremskynder ligeledes e
It inhibits glycogenolysis and gluconeogenesis, increases lipogenesis in the liver and adipose tissue and inhibits lipolysis.
optagelsen af aminosyrer i cellerne samt fremskynder proteinsyntesen og øger kaliumoptagelsen i kk
It also promotes the uptake of amino acids into cells and promotes protein synthesis and enhances the uptake of potassium into cells.
Ligesom hurtigtvirkende insulin- analoger har inhaleret humant insulin en hurtigere indsættende er
Inhaled human insulin, like fast-acting insulin analogues, has a more rapid onset of glucose lowering
glucosesænkende virkning sammenlignet med subkutant indgivet opløseligt humant insulin.
ed activity compared to subcutaneously administered soluble human insulin.
Inhaleret humant insulin har glucosesænkende virkningsvarighed sammenlignelig med subkutant indgivet hurtigtvirkende humant insulin og længere end hurtigtvirkende insulin- analoger (se figur 1). t le
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).
Subkutant Lispro (18 E) id
ris SC Lispro (18 U)
Exubera (6 mg) Gennemsnitlig GIR (% of
ho Mean GIR (% of Maximum)
m
Exubera (6mg))
Hurtigtvirkende ge
ut Fast-acting Human Insulin
humant insulin (18 maximum)
ra (18 U)
E) Læ
Time (min) (o
Tid (min)
lo
24 Fig.
n
1.
ge
Gennemsnitlig glucoseinfusionshastighed (GIR) normaliseret til GIRmax for hver forsøgsperson i behandling versus tid for raske frivillige forsøgspersoner.
Mean Glucose Infusion Rate (GIR) Normalised to GIRmax for Each Subject Treatment tn
Når humant insulin inhaleres, indtræder den glucosesænkende virkning inden for 10- 20 minutter, den maksimale effekt topper ca.
When human insulin is inhaled, the onset of glucose lowering activity is within 10-20 minutes, the uc
6 timer.
The duration of action lasts approximately 6 hours. od
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.
In subjects with type 1 or type 2 diabetes, inhaled human insulin has a faster onset of glucose pr
g al Den intraindividuelle variation af den glucosesænkende virkning af inhaleret humant insulin er generelt sammenlignelig med subkutant indgivet hurtigtvirkende humant insulin givet til
lowering effect in the early hours after dosing when compared with subcutaneously administered fast- acting human insulin. al
s forsøgspersoner med type 1 og type 2 diabetes mellitus.
The intra-subject variability of glucose lowering activity of inhaled human insulin was generally comparable to that of subcutaneously administered fast-acting human insulin in subjects with type 1 in
t
and 2 diabetes mellitus. ic
Brug af inhaleret humant insulin er forbundet med en stigning i hyppighed og mængde af
Use of inhaled human insulin is associated with an increase in frequency, and levels of insulin ed
et insulinantistoffer.
antibodies.
I et prospektivt eksplorativt 6 måneders forsøg hos forsøgspersoner med type 1 diabetes ses ingen ændringer i glucosefarmakodynamikken med inhaleret humant insulin.
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 M
er Information fra kliniske forsøg
Information on Clinical Trials
to effektiv glykæmisk kontrol sammenlignet med subkutant indgivet hurtigtvirkende humant insulin.
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.
Type 1 diabetes au e I kliniske forsøg på type 1 diabetes har patienter, der er i EXUBERA- behandling i kombination med er
26 Type 1 Diabetes
langtids - eller middellangtidsvirkende insulin, et lignende fald i HbA1c som patienter, der tager subkutant insulin alene.
In clinical trials in type 1 diabetes, patients using a regimen of EXUBERA in combination with long- or intermediate-acting insulin had similar reductions in HbA1c compared with patients taking subcutaneous insulin alone.
Procentdelen af patienter, der opnår en HbA1c < 7, 0% er sammenlignelig ng
The percentage of patients who achieved a goal of HbA1c < 7.0% was comparable between the treatment groups.
end hos dem, der kun behandles med subkutant indgivet hurtigtvirkende humant insulin. e
Fasting plasma glucose levels were significantly lower in patients treated with regimens including EXUBERA compared with those treated with subcutaneously administered fast-acting human insulin only regimens.
Type 2 diabetes kk
ed Type 2 Diabetes
middellangtidsvirkende insulin ses lignende fald i HbA1c sammenlignet med de patienter der kun er
ris Patients in a clinical trial for type 2 diabetes, who used a regimen of EXUBERA in combination with long- or intermediate-acting insulin, had similar changes in HbA1c compared with patients treated
behandles med subkutant insulin.
ho with subcutaneous insulin alone.
Fastende plasmaglucoseniveauer er signifikant lavere hos patienter, der behandles med EXUBERA t le
Fasting plasma glucose levels were significantly lower in patients treated with EXUBERA regimens
end hos dem, der behandles med subkutant insulin. id
ut compared with those treated with subcutaneous insulin.
I kliniske forsøg, der inkluderer patienter med type 2 diabetes, der ikke var velkontrollerede på orale m
ra 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
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 ge
ge improvements in HbA1c compared with patients treated with oral agents alone.
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 Læ
In most of these studies the percentages of patients achieving HbA1c < 7.0% were higher for patients using a regimen n including EXUBERA compared to patients on oral agents alone.
Fastende plasmaglucose er enten lig med eller lavere hos patienter, der behandles med EXUBERA sammenlignet med patienter, der udelukkende behandles med orale præparater.
Fasting plasma glucose was similar to or lower in patients using a regimen including EXUBERA compared to patients treated with oral lo agents alone.
Hos patienter med type 2 diabetes, der er velkontrollerede med orale antidiabetika, forbedres den glykæmiske kontrol ikke yderligere med inhaleret insulin.
In patients with type 2 diabetes sufficiently controlled with oral agents the glycaemic control was not further improved by inhaled insulin. o tn
Randomiseret, åben label forsøg med parallelle grupper blev gennemført for at undersøge FEV1 - ændringer efter initiering af EXUBERA- behandling hos type 1 og type 2 diabetikere.
Randomised, open label parallel group studies were conducted to examine FEV1 changes following uc
25 over tid under disse kliniske forsøg (Fig.
Both EXUBERA and comparator treated subjects experienced declines in lung function over time during these trials (Figures 2 and 3).
2 og 3).
Small od
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.
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. pr
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 EXUBERA - behandlede og hos 3, 4% af de sammenligningsprodukt- behandlede type 2 diabetikere.
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 al
g al s 0. 3 IN H 0. 25 C o m p a r a to r 0. 2
27 0 .3 IN H 0 .2 5 C o m p ar a to r 0 .2 0 .1 5 Change from Baseline in FEV1 (L)
il Ændring i forhold til baseline i FEV1 (l)
- 0 .1
0. 15
- 0 .1 5
t 0. 1 0. 05
ed
et 0 - 0.
- 0 .2
er - 0.
- 0 .2 5
1 - 0.
- 0 .3
1 5 - 0.
- 0 .3 5
to - 0.
- 0 .4 5
N=Antal forsøgspersoner ved baseline, uge 12, uge 24, uge 36, uge 48, uge 60, uge 72, uge 84 uge 96, LOCF.
ut N=Number of Subjects at Baseline, week 12, week 24, week 36, week 48, week 60, week 72,
Sammenligningsprodukt N=253, 238, 252, 248, 252, 249, 230, 224, 216, 253.
Comparator N= 253, 238, 252, 248, 252, 249, 230, 224, 216, 253.
Observeret ændring fra baseline i FEV1 (l) hos patienter med type 1 diabetes mellitus. læ e kk
nge from Baseline in FEV1 (L) in patients with type 1 diabetes mellitus.
Insulin human (INH) i
o
Sammenligningsprodukt er Ændring i forhold til Baseline i FEV1 (l)
n lo
0. 3
ge
0. 25 0. 2 0. 15
Comparator
t
0.3
0. 1 le (Middel + / - SD)
0.2 0.15 0.1 0.05 (Mean +/ - SD)
- 0. 05 - 0. 1 - 0. 15 m
0 -0.05 -0.1 -0.15 pr
- 0. 2 - 0. 25 ge
-0.2 -0.25 -0.3 -0.35 al
- 0. 3 - 0. 35 - 0. 4 - 0. 45 Læ
-0.4 -0.45
FEV1 reversibilitet
28 FEV1 reversibility
g al Hos type 1 diabetikere forsvandt de små forskelle imellem behandlingsgrupperne (0, 010 l til fordel for sammenligningsproduktet) indenfor 2 uger efter ophør med EXUBERA efter 12 ugers behandling.
In type 1 subjects, resolution of small treatment group differences (0.010L favouring comparator) occurred within 2 weeks of EXUBERA cessation following 12 weeks of therapy.
s Hos type 2 diabetikere forsvandt de små forskelle imellem behandlingsgrupperne (0, 039 l til fordel for
Inhaled human insulin is absorbed as rapidly as fast-acting insulin analogues and more rapidly than subcutaneously administered fast-acting
il sammenligningsproduktet) indenfor 6 uger efter ophør med EXUBERA efter 2 års behandling (figur
ho human insulin in healthy subjects and in subjects with type 1 or type 2 diabetes (see Figure 4).
t 3).
Figure 4:
I en mindre gruppe (n = 36) af blandede type 1 og 2 diabetikere behandlet med EXUBERA i
Mean changes in serum free insulin concentrations (µU/ mL) after inhalation of 4mg of
et > 36 måneder førte ophør af behandling til en gennemsnitlig FEV1 stigning på 0, 036 l over den følgende 6 måneders periode.
ut human insulin or subcutaneous injection of 12 IU fast-acting human insulin in obese subjects with
er
ra type 2 diabetes.
5. 2
ge 80
Farmakokinetiske egenskaber
70 Change From Baseline Serum Free Insulin
ris Absorption
n EXUBERA (4mg) lo 60
to Inhaleret humant insulin indtages via lungerne.
Inha le d Ins ulin Concentration (uU/ ml)
Inhaleret humant insulin absorberes lige så hurtigt som au 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). e er ng Ændring i forhold til Baseline serumfri insulin
o
læ
50
EXUBERA (4mg) Koncentration (uE/ ml)
tn
Inhaleret insulin e
S ub cuta neo us Ins uli n
Subcutaneous Insulin i kk er
30
Hurtigtvirkende insulin (12 IE) t le id m ge
20 od
Tid (min) Læ
10 pr
Figur 4:
e (m in)
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.
The time to peak insulin concentration (Tmax) is generally half of that for subcutaneously administered in
Maksimal insulinkoncentration (Tmax) nås generelt på den halve tid i forhold til subkutant administreret hurtigtvirkende humant insulin.
fast-acting human insulin.
27 Hos forsøgspersoner med type 1 diabetes mellitus var den intraindividuelle variation i AUC for inhaleret humant insulin sammenlignelig med subkutant administreret hurtigtvirkende humant insulin.
variability of AUC to subcutaneously administered fast-acting human insulin.
10%.
The relative bioavailability of EXUBERA compared to subcutaneous fast-acting human insulin is approximately 10%.
g EXUBERA ikke af Body Mass Index.
Unlike subcutaneous insulin preparations, the bioavailability of EXUBERA is not influenced by Body Mass Index.
al I et forsøg med raske forsøgspersoner øges systemisk eksponering (AUC og Cmax) af inhaleret humant
In a study in healthy subjects, systemic exposure (AUC and Cmax) of inhaled human insulin
s insulin på en tilnærmelsesvis dosisproportional måde fra 1 - 6 mg, når der maksimalt blev givet samlet
29 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.
2, 4. 2 og 4. 4).
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).
40% højere biotilgængelighed af 3 blistere à 1 mg sammenlignet med 1 blister à
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.
Jo mindre pulver i blisteren, jo mere
An explanation for the differences in bioavailability appears to be the different energy to mass ratio between the 1 and 3 mg unit blisters
to 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.
ed 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 (see sections 2 and 4.4).
2 og 4. 4).
ris Distribution
30% af det totale blisterindhold er
ho Following oral inhalation of a single dose of human insulin approximately 30% of the total blister content remains in the blister or device, 20% is deposited in the oropharynx, 10% in the conducting
i blisteren eller udstyret, 20% lagres i oropharynx, 10% i de øvre luftveje, og 40% når de nedre ng
ut airways and 40% reaches the deep lung.
Dyreforsøg viser ikke, at inhaleret humant insulin ophobes i lungerne. læ
ra Animal studies did not show that inhaled human insulin accumulates in the lung.
Særlige patientgrupper e kk
Special Populations
Rygning i
Smoking
3- 5 er
ge
2- 3 gange højere), og risikoen for hypoglykæmi kan derfor øges (se pkt.
Smoking greatly increases the rate and extent of absorption of inhaled human insulin (Cmax about 3 to 5 times and AUC about 2 to 3 times higher) and therefore could increase the risk of hypoglycaemia o
4. 3 og 4. 5). t le
(see sections 4.3 and 4.5). tn
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 id
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 uc
4. 5). m
approximately 17 and 30%, respectively (see section 4.5). od
Respiratoriske sygdomme (tilgrundliggende lungesygdomme) ge
Respiratory Diseases (Underlying Lung Disease) pr
Hos ikke- diabetikere med mild til moderat astma, der ikke er i behandling med bronkodilatorer, er Læ
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. al
AUC og Cmax af inhaleret humant insulin lidt lavere end hos forsøgspersoner, der ikke har astma.
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). in ic
4. 4).
Administration of salbutamol 30 minutes prior to EXUBERA in non-diabetic subjects with mild- moderate asthma resulted in an increase in insulin AUC and Cmax of between 25 and 51% compared to ed
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.
when EXUBERA was administered alone (see sections 4.2 and 4.5).
Nedsat nyrefunktion
30 Renal impairment
s il Køn
ed Gender
t et Der er ikke set nogen umiddelbare forskelle i absorptionen af inhaleret humant insulin mellem mandlige og kvindelige forsøgspersoner med og uden diabetes.
In subjects with diabetes and in subjects without diabetes, no apparent differences in absorption of
er Børn og unge
ho Children and adolescents
to diabetes end hurtigtvirkende humant insulin.
Bioavailability of inhaled human insulin
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.
ra relative to subcutaneously administered fast-acting human insulin was comparable to that of adult subjects with type 1 diabetes (see section 4.2).
4. 2). au e Ældre er
Elderly
Inhaleret humant insulin absorberes hurtigere hos ældre forsøgspersoner med type 2 diabetes end sub - ng
ge
kutant administreret hurtigtvirkende humant insulin.
In older subjects with type 2 diabetes, inhaled human insulin was absorbed more rapidly than subcutaneously administered fast-acting human insulin.
Biotilgængeligheden af inhaleret humant insulin i forhold til subkutant administreret hurtigtvirkende humant insulin er sammenlignelig med biotilgængeligheden hos yngre voksne forsøgspersoner med type 2 diabetes. læ
Bioavailability of inhaled human insulin lo relative to subcutaneously administered fast-acting human insulin was comparable to those in younger adult subjects with type 2 diabetes. o tn
Prækliniske sikkerhedsdata e kk
5.3 Preclinical safety data
Inhalationstoksicitetsforsøg på rotter og aber i op til 6 måneder viser ingen speciel risiko for luftrøret på grund af insulininhalationspulveret. i er
Inhalation toxicity studies in rats and monkeys for up to 6 months gave no evidence for a special risk uc
FARMACEUTISKE OPLYSNINGER t le
to the respiratory tract due to insulin inhalation powder. od