natgillin/translations-raw huggingface dataset:
Små forskelle i faldet i FEV1 imellem behandlingsgrupperne ses i gruppen behandlet med EXUBERA i sammenligning med sammenligningsprodukt- behandling.
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 e
In clinical studies of up to two years duration, there was no accelerated decline beyond 3-6 months.
4. 4 og 5. 1). i
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 er
A decline from baseline in FEV1 of > 15% occurred in 1.3% of EXUBERA-treated type 1 subjects
med type 1 diabetes og hos 5, 0% af de EXUBERA- behandlede type 2 diabetikere.
ed and in 5.0% of EXUBERA-treated type 2 subjects.
Insulinantistoffer t le
Insulin antibodies
Der kan dannes insulinantistoffer under behandling med alle insuliner inklusiv EXUBERA.
ris Insulin antibodies may develop during treatment with all insulins including EXUBERA.
I kliniske id
In clinical
patienter, som skiftede deres subkutane humane insulin ud med EXUBERA sammenlignet med 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 ge
Insulin antibody levels were higher in patients with type 1
Der er ikke identificeret Læ
ut diabetes compared to type 2 diabetes and plateaued within 6-12 months of exposure in both groups.
nogen klinisk betydning af disse antistoffer.
ra No clinical significance of these antibodies has been identified.
4. 4 Respiratorisk).
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
Ødem og refraktionsanomalier i øjet
Oedema and refraction abnormalities of the eye o tn
8 Insulinbehandling kan give natriumretention og ødem.
Insulin therapy may cause sodium retention and oedema.
Disse symptomer er normalt af forbigående karakter.
These effects are usually transitory. uc
Overdosering
4.9 Overdose od
Der kan forekomme hypoglykæmi som et resultat af et insulinoverskud i forbindelse med fødeindtagelse, energiforbrug eller begge dele.
Hypoglycaemia may occur as a result of an excess of insulin relative to food intake, energy expenditure or both. pr
Dosis -
Mild episodes of hypoglycaemia usually can be treated with oral carbohydrates.
g justering, ændring i kostplaner eller fysisk aktivitet kan være nødvendig.
Adjustments in drug dosage, meal patterns, or exercise may be needed. al
al 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
s intramuskulær/ subkutan glucagon (0, 5- 1 mg) eller koncentreret intravenøs glucoseopløsning.
Glucose ic
il 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
et Efter at have genvundet bevidstheden, anbefales det at give patienten oral kulhydrat for at undgå
Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
ris
M
Lægemidler, som anvendes ved diabetes, ATC- kode:
Medicinal products used in diabetes, ATC code:
A10AF01. e er
A10AF01
Virkningsmekanisme ng
9 Mode of Action
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 læ
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 optagelsen af aminosyrer i cellerne samt fremskynder proteinsyntesen og øger kaliumoptagelsen i e
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 i
Inhaled human insulin, like fast-acting insulin analogues, has a more rapid onset of glucose lowering
Inhaleret er
ed activity compared to subcutaneously administered soluble human insulin.
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 ho SC Lispro (18 U) Mean GIR (% of Maximum)
Exubera (6 mg) Gennemsnitlig GIR (% of
Exubera (6mg)
Hurtigtvirkende m
ut) Fast-acting
humant insulin (18 maximum) ge
ra Human Insulin (18 U)
E) Læ
ge
Tid (min)
Time (min) o
Fig.
(tn
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 Versus Time in Healthy Volunteers. uc
9 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 od
2 timer efter inhalation.
maximum effect is exerted approximately 2 hours after inhalation.
6 timer.
The duration of action lasts approximately 6 hours. pr
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 lowering effect in the early hours after dosing when compared with subcutaneously administered fast- al
Den intraindividuelle variation af den glucosesænkende virkning af inhaleret humant insulin er
acting human insulin. in
g generelt sammenlignelig med subkutant indgivet hurtigtvirkende humant insulin givet til
The intra-subject variability of glucose lowering activity of inhaled human insulin was generally ic
al forsøgspersoner med type 1 og type 2 diabetes mellitus.
comparable to that of subcutaneously administered fast-acting human insulin in subjects with type 1 and 2 diabetes mellitus. ed
s 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 M
il insulinantistoffer.
antibodies.
t 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.
et Information fra kliniske forsøg
Information on Clinical Trials
ris 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.
to Type 1 diabetes
10 Type 1 Diabetes
au 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 e 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 imellem behandlingsgrupperne. er ng
The percentage of patients who achieved a goal of HbA1c < 7.0% was comparable between the treatment groups.
Fastende plasmaglucoseniveauer er signifikant lavere hos patienter, der behandles med EXUBERA end hos dem, der kun behandles med subkutant indgivet hurtigtvirkende humant insulin. læ
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 e
ed Type 2 Diabetes
I et klinisk forsøg på type 2 diabetes patienter, som fik EXUBERA i kombination med langtids - eller kk
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
middellangtidsvirkende insulin ses lignende fald i HbA1c sammenlignet med de patienter, der kun behandles med subkutant insulin. i er
ho with subcutaneous insulin alone.
Fastende plasmaglucoseniveauer er signifikant lavere hos patienter, der behandles med EXUBERA end hos dem, der behandles med subkutant insulin. t le
Fasting plasma glucose levels were significantly lower in patients treated with EXUBERA regimens compared with those treated with subcutaneous insulin.
præparater, større gunstig ændring i HbA1c sammenlignet med de patienter, der kun bliver behandlet m
In most of these
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 ge
ge 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.
Fastende plasmaglucose er enten lig med eller lavere hos patienter, der behandles med EXUBERA sammenlignet med patienter, der udelukkende behandles Læ
Fasting plasma glucose was similar n to or lower in patients using a regimen including EXUBERA compared to patients treated with oral 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 lo control was not further improved by inhaled insulin.
FEV1 fald
FEV1 decline 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 initiation of EXUBERA therapy in type 1 and 2 subjects.
Både EXUBERA - og sammenligningsprodukt- behandlede forsøgspersoner oplevede fald i lungefunktionen 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 uc
10 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. od
0. 15
A decline from baseline in FEV1 of > 15% occurred in 1.3% of EXUBERA-treated and 1.0% of pr
il 0. 1
11 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)
t 0. 05 0
0 .1 0 .0 5 0
et - 0.
- 0 .0 5
0 5 (Middel + / - SD)
(Mean +/ - SD)
- 0.
- 0 .1
1
ed
er - 0.
- 0 .2
1 5 - 0.
- 0 .2 5
2 - 0.
- 0 .3
2 5
- 0 .3 5
ris - 0.
ris
3 5 - 0.
- 0 .4 5
to - 0.
- 0 .5
5
ho
au
60
N=Antal forsøgspersoner ved baseline, uge 12, uge 24, uge 36, uge 48, uge 60, uge 72, uge er
ut N=Number of Subjects at Baseline, week 12, week 24, week 36, week 48, week 60, week 72,
84 uge 96, LOCF.
ra week 84, week 96, LOCF.
Insulin, humant (INH) N=236, 231, 233, 233, 235, 235, 226, 217, 208, 236. ng
INH N= 236, 231, 233, 233, 235, 235, 226, 217, 208, 236.
Sammenligningsprodukt N=253, 238, 258, 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
nge from Baseline in FEV1 (L) in patients with type 1 diabetes mellitus.
i
o
Insulin human (INH) er
INH tn
Sammenligningsprodukt Ændring i forhold til Baseline i FEV1 (l)
Comparator
0. 25 0. 2
INH Washout
Insulin human udvaskning
0.25 Change from Baseline in FEV1 (L)
0. 15 le
uc
0. 1 (Middel + / - SD)
0.2 0.15 0.1 0.05 (Mean +/ - SD)
0. 05 0 id
od
- 0. 05 - 0. 1 m
0 -0.05 -0.1 -0.15 pr
- 0. 15 - 0. 2 - 0. 25 ge
-0.2 -0.25 -0.3 -0.35 al
- 0. 3 - 0. 35 - 0. 4 Læ
-0.4 -0.45
- 0. 45
in
- 0. 5
-0.5
Sammenligningsfase
Comparative Phase
Besøg (uger) N=Antal forsøgspersoner ved Baseline, uge 52, uge 104, uge +6, uge +12.
Visit (weeks) N=Number of Subjects at Baseline, week 52, week 104, week +6, week +12. ed
Observeret ændring fra baseline i FEV1 (l) hos patienter med type 2 diabetes mellitus.
M
I fase 2/ 3 forsøg afbrød 9 ud af 2498 forsøgspersoner behandlingen med EXUBERA på grund af fald i
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.
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.
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.
FEV1 reversibilitet
12 FEV1 reversibility
Hos
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 type 2 diabetikere forsvandt de små forskelle imellem behandlingsgrupperne (0, 039 l til fordel for
In type 2 subjects, resolution of small treatment group differences (0.039L favouring comparator) occurred within 6 weeks of EXUBERA cessation following 2 years of therapy (Figure 3).
il sammenligningsprodukt) inden for 6 uger efter ophør med EXUBERA efter 2 års behandling (figur 3).
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.
t I en mindre gruppe (n = 36) af blandede type 1 og 2 diabetikere behandlet med EXUBERA i
5.2 Pharmacokinetic properties
et > 36 måneder førte ophør af behandling til en gennemsnitlig FEV1 stigning på 0, 036 l over den følgende 6 måneders periode.
Inhaled human insulin is absorbed as rapidly as fast-acting insulin analogues and more rapidly than subcutaneously administered fast-acting
er
ho human insulin in healthy subjects and in subjects with type 1 or type 2 diabetes (see Figure 4).
5. 2
ut ra 80
Farmakokinetiske egenskaber
EXUBERA (4mg)
ris Absorption
ge 70 Change From Baseline Serum Free Insulin
to Inhaleret humant insulin indtages via lungerne.
60 n Inha le d Ins ulin Concentration (uU/ ml)
læ
lo
EXUBERA (4mg) e Koncentration (uE/ ml)
50
Inhaleret insulin kk
S ub cuta neo us Ins uli n
Subcutaneous Insulin i er
40 o
Hurtigtvirkende insulin (12 IE) t le id m ge
Fast-acting Human Insulin (12 IU) tn
Tid (min) Læ
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.
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 type 2 diabetes. al in
Maksimal insulinkoncentration nås generelt efter 45 minutter ved inhaleret humant insulin.
Peak insulin concentration is reached generally by 45 minutes for inhaled ic
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.
In subjects with type 1 diabetes mellitus, inhaled human insulin had a comparable intrasubject M
12 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.
Den relative biotilgængelighed af EXUBERA sammenlignet med subkutant hurtigtvirkende humant
The relative bioavailability of EXUBERA compared to subcutaneous fast-acting human insulin is approximately 10%.
al EXUBERA ikke af Body Mass Index.
Unlike subcutaneous insulin preparations, the bioavailability of EXUBERA is not influenced by Body Mass Index.
s 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
I et forsøg, hvor 3 blistere af lægemiddelformen 1 mg
13 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.
30% og 40% højere end inhalation af 1 blister à 3 mg, hvilket viser, at 3 blistere à
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 3 mg hos raske forsøgspersoner.
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.
to energiforskellen i masseratio mellem blistere à 1 og 3 mg.
An explanation for the differences in bioavailability appears to be the different energy to mass ratio between the 1 and 3 mg unit blisters
Jo mindre pulver i blisteren, jo mere effektivt kan inhalatoren opdele eller de- agglomerere pulveret, hvilket fører til en større andel af au 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). e Distribution er
ris Distribution
30% af det totale blisterindhold ng
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 luftveje. læ
ut airways and 40% reaches the deep lung.
Dyreforsøg viser ikke, at inhaleret humant insulin ophobes i lungerne. e
ra Animal studies did not show that inhaled human insulin accumulates in the lung.
Særlige patientgrupper kk
Special Populations
Rygning i er
Smoking
4. 3 og 4. 5). t le
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
Når EXUBERA gives til raske frivillige forsøgspersoner, efter at de i et kontrolleret forsøgsmiljø har id
(see sections 4.3 and 4.5). tn
været udsat for passiv rygning fra cigaretter i 2 timer, nedsættes insulin AUC og Cmax med henholdsvis m
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). ge
approximately 17 and 30%, respectively (see section 4.5). od
Respiratoriske sygdomme (underliggende lungesygdomme) Læ
Respiratory Diseases (Underlying Lung Disease) pr
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.
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
4. 4).
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
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.
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
4. 2 og 4. 5).
M
4. 5).
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).
4. 2).
The effect of renal impairment on the absorption of inhaled human insulin has not been studied (see section 4.2).
Nedsat leverfunktion
14 Hepatic impairment
4. 2).
The effect of hepatic impairment on the absorption of inhaled human insulin has not been studied (see section 4.2).
s il Køn
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 inhaled human insulin were observed between men and women.
er Børn og unge
ed Children and adolescents
ris Inhaleret humant insulin absorberes hurtigere hos børn (6- 11 år) og unge (12- 17 år) med type 1
In children (6-11 years) and adolescents (12-17 years) with type 1 diabetes, inhaled human insulin
to diabetes end hurtigtvirkende humant insulin.
ris was absorbed more rapidly than fast-acting human insulin.
4. 2). au e Ældre er
ho subjects with type 1 diabetes (see section 4.2).
Inhaleret humant insulin absorberes hurtigere hos ældre forsøgspersoner med type 2 diabetes end sub - ng
Elderly
kutant administreret hurtigtvirkende humant insulin.
ut ra 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 relative to subcutaneously administered fast-acting human insulin was comparable to those in younger adult subjects with type 2 diabetes.
Inhalationstoksicitetsforsøg på rotter og aber i op til 6 måneder viser ingen speciel risiko for luftrøret på grund af insulininhalationspulveret. i er
5.3 Preclinical safety data n ge lo 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. o tn
FARMACEUTISKE OPLYSNINGER t le
PHARMACEUTICAL PARTICULARS uc
Fortegnelse over hjælpestoffer id
6.1 List of excipients od
Mannitol m
Mannitol Glycine pr
Glycin Natriumcitrat (som dihydrat) ge
Sodium Citrate (as dihydrate) Sodium Hydroxide al
Natriumhydroxid Læ
6.2 Incompatibilities in
Uforligeligheder
Not applicable. ic
Ikke relevant.
6.3 Shelf life ed
Opbevaringstid
2 years.
2 år.
M