natgillin/translations-raw huggingface dataset:
substituted for one 3 mg unit dose blister (see sections 2, 4.2 and 5.2). ed
Zato se enega 3 - mg pretisnega omota za enkratni odmerek ne sme nadomestiti s tremi 1- mg (glejte poglavja 2, 4. 2 in 5. 2).
M
20 Če bolnik trenutno nima na voljo 3- mg pretisnega omota, naj uporabi dva 1- mg pretisna omota in naj natančno nadzira glukozo v krvi.
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
et Hipoglikemija, ki je na splošno najpogostejši neželeni učinek zdravljenja z insulinom in tudi
20 the insulin requirement.
om zdravljenja z zdravilom EXUBERA in številnimi peroralnimi antidiabetiki, se lahko pojavi, če je odmerek insulina prevelik glede na potrebo po njem.
They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
za kožo, utrujenost, živčnost ali tremor, tesnobo, nenavadno utrujenost ali šibkost, zmedenost, oteženo koncentriranje, zaspanost, čezmerno lakoto, spremembe vida, glavobol, navzejo in palpitacije.
Severe hypoglycaemia may lead to unconsciousness and/ or convulsions and may result in temporary or permanent impairment of brain function or even death.
Težka hipoglikemija lahko povzroči nezavest in/ ali konvulzije, začasno ali trajno okvaro delovanja
In order to be able to
a možganov ali celo smrt.
ed take action immediately, patients should carry glucose with them at all times.
nj Hipoglikemijo lahko običajno popravimo s takojšnjim zaužitjem ogljikovih hidratov.
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia.
Da bi lahko lje bolniki nemudoma ukrepali, morajo vedno nositi s seboj glukozo.
ris Patients whose blood glucose control is greatly improved e. g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be advised
Opustitev obroka ali nenačrtovana naporna telesna aktivnost lahko povzroči hipoglikemijo. vo Bolnikom, ki se jim kontrola glukoze v krvi možno izboljša npr. z intenzivnim insulinskim zdravljenjem, se lahko spremenijo običajni opozorilni simptomi hipoglikemije, zato jim moramo do
ho accordingly.
ustrezno svetovati.
ut ra A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin to human insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
hipoglikemične reakcije, so poročali, da so bili zgodnji opozorilni simptomi hipoglikemije manj izraženi ali drugačni kot pri njihovem prejšnjem insulinu. a
n
Pred potovanjem skozi različne časovne pasove je treba bolniku svetovati, naj se posvetuje z m
ge
zdravnikom, ker utegne to pomeniti, da bo moral bolnik jemati insulin in uživati dnevne obroke ob drugih časih kot sicer. ni
Before travelling between different time zones, the patient should be advised to consult the doctor, since this may mean that the patient has to take insulin and meals at different times. lo Inadequate dosage or discontinuation of treatment especially in insulin-dependant diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal. o tn
Nezadostno odmerjanje ali prekinitev zdravljenja, posebno pri diabetikih, odvisnih od insulina, lahko lo
When used with other antidiabetic agents, the dose of each agent should be carefully adjusted to determine the optimal dose required to achieve the desired pharmacological effect. uc
Kadar to zdravilo uporabljamo skupaj z drugimi antidiabetiki, je treba odmerek vsakega zdravila skrbno prilagoditi, da določite optimalni odmerek, ki je potreben za dosego želenega farmakološkega ra
Insulin requirements may be altered during intercurrent conditions such as illness, emotional disturbances, or stress. od
Potrebe po insulinu se lahko spremenijo med interkurentnimi stanji, na primer boleznimi, čustvenimi motnjami ali stresom.
Pulmonary Safety pr
Varnost za dihala
Underlying respiratory disorders al
Obstoječe bolezni dihal
EXUBERA should not be used in patients with lung disease such as asthma and COPD, as there are insufficient data to support the safe use in these patients. in ic
Bolniki s pljučnimi boleznimi, kakršni sta astma in KOPB, ne smejo uporabljati EXUBERE, ker so podatki, ki bi govorili v prid varne uporabe tega zdravila pri takšnih bolnikih, pomankljivi.
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 ed
21 Sočasna uporaba bronhodilatatorjev, kot je salbutamol, lahko poveča absorpcijo EXUBERE in zato lahko poveča tveganje za hipoglikemijo, kadar je uporabljen za odpravo akutnih respiratornih simptomov (glejte poglavje 4. 5).
21 Decline in pulmonary function
om Zmanjšano delovanje pljuč
ed baseline FEV1 < 70% predicted have not been established and the use of inhaled human insulin in this population is not recommended A follow-up lung function measurement is recommended after the first 6 months of therapy.
nj inhaliranje pri bolnikih z izhodiščnim FEV1 < 70% nista bili določeni in uporaba humanega insulina za inhaliranje pri tej populaciji ni priporočljiva. Po prvih 6 mesecih zdravljenja je priporočljiva lje ponovna ocena pljučne funkcije.
ho 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
Pri bolnikih, ki se jim FEV1 potrjeno (npr. na vsaj dveh zaporednih testiranjih) zmanjša za > 20% v primerjavi z izhodiščnim FEV1, je treba zdravljenje z EXUBERO prekiniti in bolnika nadzirati, kot je klinično indicirano.
There is no experience with the reinstitution of EXUBERA therapy in patients
Pri bolnikih, ki se jim delovanje pljuč popravi, ni izkušenj s ponovno uvedbo EXUBERE. ā ve
among Exubera-treated patients, and 1 newly diagnosed case among comparator treated patients.
V pomarketinškim obdobju je bil opisan 1 primer primarnega malignoma pljuč pri bolniku, zdravljenem z zdravilom EXUBERA.
There has also been 1 post-marketing report of a primary lung malignancy in an Exubera-treated patient.
V kontroliranih kliničnih preskušanjih zdravila EXUBERA je bila incidenca novega primarnega raka pljuč med uporabniki zdravila EXUBERA 0, 130 na 100 bolnik- let izpostavljenosti raziskovanemu zdravilu (5 primerov v 3. 800 bolnik- letih) in med uporabniki primerjalnega zdravila 0, 03 (1 primer v 3. 900 bolnik- letih).
There were too few in
22 povezano z zdravilom EXUBERA.
22 Administration of fluticasone prior to EXUBERA does not appear to affect insulin absorption (see section 5.2).
Uporaba flutikazona pred EXUBERO ne vpliva na absorpcijo insulina (glejte poglavje 5. 2).
Active smoking greatly enhances whereas passive exposure to tobacco smoke in non-smokers decreases the rate and extent of absorption of EXUBERA (see sections 4.3 and 5.2).
pr Aktivno kajenje močno poveča hitrost in obseg absorpcije EXUBERE, pasivna izpostavljenost nekadilcev tobačnemu dimu pa ju zmanjša (glejte poglavji 4. 3 in 5. 2).
23 The table below contains adverse reactions seen in controlled clinical studies including more than 1970 patients exposed to EXUBERA.
23 Spodnja preglednica vsebuje neželene učinke, ki so jih opazili v kontroliranih kliničnih študijah, ki so zajele več kot 1970 bolnikov, izpostavljenih zdravilu EXUBERA.
Productive Cough Throat Irritation
dispneja produktivni kašelj, vnetje žrela
Bronchospasm Wheezing
epistaksa bronhospazem sopihanje disfonija
Dysphonia
suho žrelo,
Pharyngolaryngeal Pain
faringolaringealna bolečina
ho Tonsillar Disorder
za težave z mandeljni
General
a nj
ra Disorders and Administration Site Conditions
Splošne težave in spremembe na mestu aplikacije
n
lje
ge
bolečina v prsih
In the overall clinical program, including uncontrolled extension studies, there were two reports of pleural effusion in which a treatment-related effect could not be excluded. lo Hypoglycaemia o
vo Opomba: v celotnem kliničnem programu (vključno z nekontroliranimi podaljšanji študij) so zabeležili dva primera plevralnega izliva, pri katerih ni bilo mogoče izključiti povezanosti s terapijo. do
As with other insulins, hypoglycaemia was the most frequently observed undesirable effect in patients tn
Podobno kot pri drugih insulinih, je hipoglikemija najpogostejši neželeni učinek pri bolnikih, ve
treated with EXUBERA. uc
zdravljenih z zdravilom EXUBERA.
Cough
Kašelj a
The cough tended to occur within seconds to minutes after insulin inhalation and was predominantly od
Kašelj se je navadno pojavljal v nekaj sekundah do nekaj minutah po inhalaciji insulina in je bil, kar se m
mild in severity.
izraženosti tiče, pretežno blag.
One percent of patients discontinued EXUBERA treatment due to cough. pr
En odstotek bolnikov je prekinil zdravljenje z zdravilom EXUBERA zaradi kašlja. ni
Dyspnoea al
Dispneja lo
In EXUBERA treated subjects in
Od oseb, zdravljenih z zdravilom vi
0.4% discontinued treatment due to dyspnoea. ic
EXUBERA, jih je 0, 4% prekinilo zdravljenje zaradi dispneje. ra
The majority (> 95%) of these events was reported as mild to M
Za večino (> 95%) teh dogodkov so poročali, da so bili blagi do zmerni.
24 Other reactions
24 Drugi neželeni učinki
ed and in 5.0% of EXUBERA-treated type 2 subjects.
om bolnikov, pri bolnikih z diabetesom tipa 2 pa pri 5, 0% bolnikov.
25 Mode of Action
25 Način delovanja
ris SC Lispro (18 U)
SC Lispro (18 i. e.)
ho Mean GIR (% of Maximum)
pr povprečna GIR (% maksimuma)
Exubera (6mg))
Exubera (6 mg) hitrodelujoči
ra (18 U)
za humani insulin (18 i. e.)
Time (min) (o
a nj lje vo čas (min) do
Mean Glucose Infusion Rate (GIR) Normalised to GIRmax for Each Subject Treatment tn
Povprečna hitrost infuzije glukoze (GIR), normalizirana na GIRmax za zdravljenje vsakega preiskovanca v primerjavi s časom pri zdravih prostovoljcih. ā
When human insulin is inhaled, the onset of glucose lowering activity is within 10-20 minutes, the uc
Po inhalaciji humanega insulina nastopi aktivnost zniževanja glukoze v 10- 20 minutah, učinek je ve
maximum effect is exerted approximately 2 hours after inhalation.
največji približno 2 uri po inhalaciji.
The duration of action lasts approximately 6 hours. od
Delovanje traja približno 6 ur.
In subjects with type 1 or type 2 diabetes, inhaled human insulin has a faster onset of glucose pr
Pri bolnikih z diabetesom tipa 1 ali tipa 2 ima humani insulin za inhaliranje hitrejši nastop učinka a
lowering effect in the early hours after dosing when compared with subcutaneously administered fast- acting human insulin. al
glede zniževanja glukoze v prvih urah po odmerku kot subkutano injicirani hitrodelujoči humani m
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
Variabilnost aktivnosti zniževanja glukoze humanega insulina za inhaliranje je bila na splošno primerljiva s tisto pri subkutano apliciranem hitrodelujočem humanem insulinu pri bolnikih z diabetesom mellitusom tipa 1 in 2. lo vi
Use of inhaled human insulin is associated with an increase in frequency, and levels of insulin ed
Uporaba humanega insulina za inhaliranje se kaže z zvečanjem pogostnosti in koncentracije protiteles.
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
Zd
26 Type 1 Diabetes
26 Diabetes tipa 1
ho with subcutaneous insulin alone.
Večji odstotni delež bolnikov, zdravljenih z zdravilom EXUBERA, je dosegel HbA1c < 7, 0%.
Fasting plasma glucose levels were significantly lower in patients treated with EXUBERA regimens
za Koncentracije plazemske glukoze na tešče so bile pomembno nižje pri bolnikih, zdravljenih s shemami z zdravilom EXUBERA, kot pri bolnikih, zdravljenih s subkutanim insulinom.
ut compared with those treated with subcutaneous insulin.
V kliničnih preskušanjih na bolnikih z diabetesom tipa 2, pri katerih glikemična kontrola samo s
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
a peroralnimi antidiabetiki ni zadostna, se je HbA1c bolj izboljšal pri bolnikih, zdravljenih s shemami z
ge improvements in HbA1c compared with patients treated with oral agents alone.
nj zdravilom EXUBERA samim ali v kombinaciji s peroralnimi antidiabetiki, kot pri bolnikih, zdravljenih samo s peroralnimi antidiabetiki.
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.
V večini od teh študij so bili odstotni deleži bolnikov, ki lje so dosegli HbA1c < 7, 0%, višji pri bolnikih, ki so uporabljali shemo, ki je vključevala zdravilo EXUBERA, kot pri bolnikih, zdravljenih samo s peroralnimi antidiabetiki.
Fasting plasma glucose was similar to or lower in patients using a regimen including EXUBERA compared to patients treated with oral lo agents alone.
Insulin za inhaliranje ni dodatno do
In patients with type 2 diabetes sufficiently controlled with oral agents the glycaemic control was not further improved by inhaled insulin. o tn
izboljšal urejenosti glikemije pri bolnikih z diabetesom tipa 2, ki so imeli bolezen zadostno urejeno s peroralnimi antidiabetiki.
FEV1 decline
Zmanjšanje FEV1 ā ve
Randomised, open label parallel group studies were conducted to examine FEV1 changes following uc
Za raziskovanje sprememb FEV1 po uvedbi zdravljenja z zdravilom EXUBERA pri bolnikih z diabetesom tipa 1 in tipa 2 so opravili randomizirane odprte študije s paralelnimi skupinami.
Small od
Tako pri bolnikih, zdravljenih z zdravilom EXUBERA, kot pri bolnikih, zdravljenih s primerjalnim zdravilom, a
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
se je med temi preskušanji sčasoma zmanjšala pljučna funkcija (sliki 2 in 3).
type 2 subjects. in ic ed M
Po 2 letih zdravljenja so m
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)
se pojavile majhne razlike med skupinami, zdravljenimi z različnimi zdravili (v korist primerjalnega zdravila), sprememba od izhodišča je bila 0, 034 L pri tipu 1 in 0, 039 L pri tipu 2. ni
ut N=Number of Subjects at Baseline, week 12, week 24, week 36, week 48, week 60, week 72,
Pri bolnikih z diabetesom tipa 1 se je zmanjšanje FEV1 za > 15% od izhodišča pojavilo pri 1, 3% bolnikov, zdravljenih z zdravilom EXUBERA, in pri 1, 0% bolnikov, zdravljenih s primerjalnim lo
Comparator N= 253, 238, 252, 248, 252, 249, 230, 224, 216, 253.
zdravilom; pri bolnikih z diabetesom tipa 2 se je takšno zmanjšanje FEV1 pojavilo pri 5, 0% bolnikov, zdravljenih z zdravilom EXUBERA, in pri 3, 4% bolnikov, zdravljenih s primerjalnim zdravilom. vi ra Zd
Observed Cha
27 et om pr za a nj Slika 2.
nge from Baseline in FEV1 (L) in patients with type 1 diabetes mellitus.
Opažena sprememba FEV1 (L) od izhodišča pri bolnikih z diabetesom mellitusom tipa 1. lje vo
INH tn
INH do
0.25 Change from Baseline in FEV1 (L)
prim. zdravilo spiranje INH 0. 3 0. 2 5 Sprememba FEV1 (l) od izhodišča
uc
0. 2 ā
0.2 0.15 0.1 0.05 (Mean +/ - SD)
0. 1 5 0. 1 (povprečje + / - SD)
od
0. 0 5 ve
0 -0.05 -0.1 -0.15 pr
0 - 0. 0 5 - 0. 1 - 0. 1 5 - 0. 2 a
-0.2 -0.25 -0.3 -0.35 al
- 0. 2 5 - 0. 3 m
-0.4 -0.45
- 0. 3 5 - 0. 4 - 0. 4 5 ni
ic
lo
Visit (weeks) N=Number of Subjects at Baseline, week 52, week 104, week +6, week +12. ed
obisk (tedni) N=število bolnikov v izhodišču, v 52. tednu, v 104. tednu, tednu +6, tednu +12. vi
Comparator N=145, 143, 125, 129, 120.
Primerjano zdravilo N=145, 143, 125, 129, 120. ra Zd
M
Opažena sprememba FEV1 (L) od izhodišča pri bolnikih z diabetesom mellitusom tipa 2.
28 FEV1 reversibility
28 Reverzibilnost FEV1
5.2 Pharmacokinetic properties
om 5. 2 Farmakokinetične lastnosti
ed Absorption
Absorpcija
ris Inhaled human insulin is delivered by the pulmonary route.
pr Humani insulin za inhaliranje se absorbira skozi pljuča.
Inhaled human insulin is absorbed as rapidly as fast-acting insulin analogues and more rapidly than subcutaneously administered fast-acting
Pri zdravih preiskovancih in preiskovancih z diabetesom tipa 1 ali tipa 2 se humani insulin za inhaliranje absorbira enako hitro kot hitrodelujoči
ho human insulin in healthy subjects and in subjects with type 1 or type 2 diabetes (see Figure 4).
za insulinski analogi in hitreje kot subkutano aplicirani hitrodelujoči humani insulin (glejte sliko 4).
Mean changes in serum free insulin concentrations (µU/ mL) after inhalation of 4mg of
Povprečne spremembe serumskih koncentracij prostega insulina (µi. e. / ml) po inhalaciji 4 mg m
ut human insulin or subcutaneous injection of 12 IU fast-acting human insulin in obese subjects with
humanega insulina ali subkutani injekciji 12 i. e. hitrodelujočega topnega humanega insulina pri ni
ra type 2 diabetes.
debelih bolnikih s sladkorno boleznijo tipa 2.
The time to peak insulin concentration (Tmax) is generally half of that for subcutaneously administered in
Čas do najvišje koncentracije insulina (Tmax) je na splošno za polovico krajši od tistega pri subkutano lo
fast-acting human insulin.
injiciranem hitrodelujočem topnem humanem insulinu.
Intrasubject variability of time to peak insulin concentrations was less for inhaled human insulin than for subcutaneous fast-acting human insulin in subjects with type 1 or 2 diabetes. ed
tipa 1 in 2 je bila intraindividualna variabilnost časa do največje koncentracije insulina ob uporabi ra
In subjects with type 1 diabetes mellitus, inhaled human insulin had a comparable intrasubject M
Zd
The relative bioavailability of EXUBERA compared to subcutaneous fast-acting human insulin is approximately 10%.
Relativna biološka uporabnost EXUBERE je v primerjavi s podkožno uporabljenim hitrodelujočim humanim insulinom približno 10%.
In a study in healthy subjects, systemic exposure (AUC and Cmax) of inhaled human insulin
29 V študiji na zdravih osebah se je sistemska izpostavljenost (AUC in Cmax) humanega insulina za inhaliranje zvečala med odmerkoma 1 mg in 6 mg približno proporcionalno odmerku, če so bolniki prejeli največ dva pretisna omota katerekoli jakosti ali kombinacijo obeh jakosti.
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).
V študiji, v kateri so obliko odmerjanja s tremi 1- mg pretisnimi omoti primerjali z enim 3- mg pretisnim omotom, sta bili Cmax in AUC po inhalaciji treh 1- mg pretisnih omotov približno za 30% in 40% večji kot po inhalaciji iz enega 3- mg pretisnega omota, kar kaže na to, da trije 1- mg pretisni omoti niso zamenljivi z enim 3 - mg pretisnim omotom (glejte poglavja 2, 4. 2 in 4. 4).
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.
Razlaga različne biološke
An explanation for the differences in bioavailability appears to be the different energy to mass ratio between the 1 and 3 mg unit blisters
om uporabnosti je verjetno različno razmerje med energijo in maso pri 1- mg in 3- mg pretisnih omotih za enkratni odmerek.
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).
Kolikor manj je namreč praška v pretisnem omotu, toliko učinkoviteje inhalator loči oz. deaglomerira prašek, zato je delež manjših aerodinamičnih velikosti delcev pri 1- mg pretisnem omotu večji (glejte poglavji 2 in 4. 4).
ris Distribution
pr Porazdelitev
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
za Po peroralni inhalaciji posamičnega odmerka humanega insulina ostane približno 30% celotne vsebine pretisnega omota v omotu ali v napravi, 20% se ga odloži v orofarinksu, 10% v prehodnih
ut airways and 40% reaches the deep lung.
a dihalnih poteh, 40% pa doseže globoke predele pljuč.
ra Animal studies did not show that inhaled human insulin accumulates in the lung.
nj Študije na živalih niso pokazale, da bi se humani insulin za inhaliranje kopičil v pljučih. lje Posebne skupine bolnikov vo Kajenje do
Special Populations
Kajenje močno poveča delež in obseg absorpcije humanega insulina za inhaliranje (Cmax je za 3 - do 5 - krat večja, AUC za 2 - do 3 - krat večja) in bi zato lahko povečalo tveganje za hipoglikemijo (glejte poglavje 4. 3). ā
Smoking
Ko so zdravilo EXUBERA dajali zdravim prostovoljcem po dveurni pasivni izpostavljenosti ve
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
cigaretnemu dimu v kontroliranih eksperimentalnih razmerah, sta se AUC in Cmax insulina zmanjšala za približno 17 oziroma 30% (glejte poglavje 4. 5). a
(see sections 4.3 and 4.5). tn
Bolezni dihal (osnovne bolezni pljuč) 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
Pri nediabetičnih preiskovancih z blago do zmerno astmo sta bili AUC in Cmax humanega insulina za ni
Respiratory Diseases (Underlying Lung Disease) pr
inhaliranje v odsotnosti zdravljenja z bronhodilatatorjem nekoliko manjši kot pri preiskovancih brez astme (glejte poglavje 4. 4). lo
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
Pri nediabetičnih preiskovancih s KOPB se je absorpcija humanega insulina za inhaliranje zdela večja vi
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
kot pri osebah brez KOPB (glejte poglavje 4. 4). ra
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
Uporaba salbutamola 30 minut pred EXUBERO je pri nediabetičnih preiskovancih z blago do zmerno astmo povzročila od 25 do 51% povečanje AUC in Cmax v primerjavi z uporabo EXUBERE same Zd
M
(glejte poglavji 4. 2 in 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).
Uporaba flutikazona 30 minut pred EXUBERO pri nediabetičnih preiskovancih z blago do zmerno astmo ni vplivala na farmakokinetiko EXUBERE (glejte poglavje 4. 5).
30 Renal impairment
Okvare ledvic
The effect of renal impairment on the absorption of inhaled human insulin has not been studied (see section 4.2).
Učinka ledvičnih okvar na absorpcijo humanega insulina za inhaliranje niso proučevali (glejte poglavje 4. 2).
Hepatic impairment
30 Okvare jeter
The effect of hepatic impairment on the absorption of inhaled human insulin has not been studied (see section 4.2).
Učinka okvar jeter na absorpcijo humanega insulina za inhaliranje niso proučevali (glejte poglavje 4. 2).
ed Gender
Spol
In subjects with diabetes and in subjects without diabetes, no apparent differences in absorption of
Pri osebah s sladkorno boleznijo in osebah brez nje niso opazili jasnih razlik med moškimi in ženskami glede absorpcije humanega insulina za inhaliranje.
ho Children and adolescents
et Otroci in mladostniki