natgillin/translations-raw huggingface dataset:
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.
V manjši mešani skupini (n=36) bolnikov s tipom 1 in tipom 2, zdravljenih z zdravilom EXUBERA > 36 mesecev dolgo, je
ho human insulin in healthy subjects and in subjects with type 1 or type 2 diabetes (see Figure 4).
et prekinitev zdravljenja povzročila povprečno zvečanje FEV1 za 0, 036 L v naslednjih 6 mesecih.
EXUBERA (4mg)
om 5. 2 Farmakokinetične lastnosti
ge 70 Change From Baseline Serum Free Insulin
Absorpcija
60 n Inha le d Ins ulin Concentration (uU/ ml)
pr Humani insulin za inhaliranje se absorbira skozi pljuča.
Fast-acting Human Insulin (12 IU) tn
za insulinski analogi in hitreje kot subkutano aplicirani hitrodelujoči humani insulin (glejte sliko 4).
10 od
a nj lje vo do ā ve a m ni
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
Povprečne spremembe serumskih koncentracij prostega insulina (µ i. e. / ml) po inhalaciji 4 mg humanega insulina ali subkutani injekciji 12 i. e. hitrodelujočega humanega insulina pri debelih lo
The time to peak insulin concentration (Tmax) is generally half of that for subcutaneously administered fast-acting human insulin.
Čas do najvišje koncentracije insulina (Tmax) je na splošno za polovico krajši od tistega pri subkutano ra
Peak insulin concentration is reached generally by 45 minutes for inhaled ic
Najvišja koncentracija insulina se pri humanem insulinu za inhaliranje doseže na splošno po 45 minutah.
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
Pri preiskovancih z diabetesom tipa 1 in 2 je Zd
In subjects with type 1 diabetes mellitus, inhaled human insulin had a comparable intrasubject M
bila intraindividualna variabilnost časa do največje koncentracije insulina ob uporabi insulina za inhaliranje manjša kot ob subkutani uporabi hitrodelujočega humanega insulina.
variability of AUC to subcutaneously administered fast-acting human insulin.
Pri preiskovancih z diabetesom mellitusom tipa 1 je bila intraindividualna variabilnost AUC humanega insulina za inhaliranje primerljiva kot pri subkutano apliciranem hitrodelujočem humanem insulinu.
The relative bioavailability of EXUBERA compared to subcutaneous fast-acting human insulin is approximately 10%.
13 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
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.
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.
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
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).
et 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.
om Pri zdravih preiskovancih je bila biološka uporabnost treh 1- mg pretisnih omotov za enkratni odmerek približno 40% večja kot enega 3- mg pretisnega omota za enkratni odmerek.
An explanation for the differences in bioavailability appears to be the different energy to mass ratio between the 1 and 3 mg unit blisters
Razlaga različne biološke uporabnosti je verjetno različno razmerje med energijo in maso pri 1- mg in 3- mg pretisnih omotih za
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
ris Distribution
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
a Po peroralni inhalaciji posamičnega odmerka humanega insulina ostane približno 30% celotne
ut airways and 40% reaches the deep lung.
nj vsebine pretisnega omota v omotu ali v napravi, 20% se ga odloži v orofarinksu, 10% v prehodnih lje dihalnih poteh, 40% pa doseže globoke predele pljuč.
ra Animal studies did not show that inhaled human insulin accumulates in the lung.
Študije na živalih niso pokazale, da bi se humani insulin za inhaliranje kopičil v pljučih. vo
Special Populations
Posebne skupine bolnikov do
Smoking
Kajenje ā
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
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 ve
(see sections 4.3 and 4.5). tn
poglavji 4. 3 in 4. 5).
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
Ko so zdravilo EXUBERA dajali zdravim prostovoljcem po dveurni pasivni izpostavljenosti a
approximately 17 and 30%, respectively (see section 4.5). od
cigaretnemu dimu v kontroliranih eksperimentalnih razmerah, sta se AUC in Cmax insulina zmanjšala m
Respiratory Diseases (Underlying Lung Disease) pr
za približno 17 oziroma 30% (glejte poglavje 4. 5). ni
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
Bolezni dihal (osnovne bolezni pljuč) lo
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
Pri nediabetičnih preiskovancih z blago do zmerno astmo sta bili AUC in Cmax humanega insulina za inhaliranje v odsotnosti zdravljenja z bronhodilatatorjem nekoliko manjši kot pri preiskovancih brez vi
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
astme. ra
when EXUBERA was administered alone (see sections 4.2 and 4.5).
Pri nediabetičnih preiskovancih s KOPB se je absorpcija humanega insulina za inhaliranje zdela večja kot pri osebah brez KOPB (glejte poglavje 4. 4).
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 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 (glejte poglavji 4. 2 in 4. 5).
The effect of renal impairment on the absorption of inhaled human insulin has not been studied (see section 4.2).
Uporaba flutikazona 30 minut pred EXUBERO pri nediabetičnih preiskovancih z blago do zmerno astmo ni vplivala na farmakokinetiko EXUBERE (glejte poglavje 4. 5).
14 Hepatic impairment
14 Okvare ledvic
The effect of hepatic 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).
Gender
Okvare jeter
In subjects with diabetes and in subjects without diabetes, no apparent differences in absorption of inhaled human insulin were observed between men and women.
Učinka okvar jeter na absorpcijo humanega insulina za inhaliranje niso proučevali (glejte poglavje 4. 2).
ed Children and adolescents
et Spol
In children (6-11 years) and adolescents (12-17 years) with type 1 diabetes, inhaled human insulin
om Pri osebah s sladkorno boleznijo in osebah brez nje niso opazili jasnih razlik med moškimi in ženskami glede absorpcije humanega insulina za inhaliranje.
ris was absorbed more rapidly than fast-acting human insulin.
za Pri otrocih (6- 11 let) in mladostnikih (12- 17 let) z diabetesom tipa 1 se je humani insulin za inhaliranje absorbiral hitreje kot hitrodelujoči humani insulin.
Bioavailability of inhaled human insulin relative to subcutaneously administered fast-acting human insulin was comparable to that of adult
Biološka uporabnost humanega insulina za inhaliranje glede na subkutano injicirani hitrodelujoči humani insulin je bila primerljiva s tisto pri
ho subjects with type 1 diabetes (see section 4.2).
a odraslih bolnikih z diabetesom tipa 1 (glejte poglavje 4. 2).
ut ra In older subjects with type 2 diabetes, inhaled human insulin was absorbed more rapidly than subcutaneously administered fast-acting human insulin.
nj Starejši bolniki lje Pri starejših bolnikih z diabetesom tipa 2 se je humani insulin za inhaliranje absorbiral hitreje kot subkutano injicirani hitrodelujoči humani insulin.
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.
Biološka uporabnost humanega insulina za vo inhaliranje glede na subkutano injicirani hitrodelujoči humani insulin je bila primerljiva s tisto pri mlajših odraslih bolnikih z diabetesom tipa 2. do
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
Študije toksičnosti inhalacije pri podganah in opicah, ki so trajale do 6 mesecev dolgo, niso dale ā
PHARMACEUTICAL PARTICULARS uc
FARMACEVTSKI PODATKI a m
6.1 List of excipients od
6. 1 Seznam pomožnih snovi ni
Mannitol Glycine pr
manitol glicin natrijev citrat (v obliki dihidrata) lo
Sodium Citrate (as dihydrate) Sodium Hydroxide al
natrijev hidroksid vi
6.2 Incompatibilities in
6. 2 Inkompatibilnosti ra
Not applicable. ic
Zd
6.3 Shelf life ed
6. 3 Rok uporabnosti
After first opening the foil overwrap:
Po prvem odprtju prekrivne folije:
3 months.
3 mesece.
Store below 30oC.
Shranjujte pri temperaturi do 30o C.
Store below 25oC.
Po odprtju prekrivne folije: shranjujte pri temperaturi do 25o C.
15 The inhaler and its components should be stored and used in a dry place.
Inhalator in njegove sestavne dele shranjujte in uporabljajte na suhem.
Do not refrigerate or freeze the insulin inhaler.
et Inhalatorja za insulin ne shranjujte v hladilniku in ga ne zamrzujte.
6.5 Nature and contents of container
om 6. 5 Vrsta ovojnine in vsebina
One blister card contains 6 perforated unit dose blisters (PVC/ Aluminium).
Vsaka ploščica s pretisnimi omoti vsebuje 6 perforiranih pretisnih omotov za enkratni odmerek
Five blister cards are in a clear plastic (PET) thermoformed tray with a desiccant and covered with a clear plastic (PET) lid.
Podstavek je
The tray is sealed in a foil laminate pouch with a desiccant.
za neprodušno zaprt v vrečki iz laminirane folije s sušilnim sredstvom.
ed Packaging sizes supplied:
Na voljo so naslednje velikosti pakiranj:
ris • Cardboard box containing 30 x 1 PVC/ Aluminium perforated unit dose blisters (1 pouch)
a • Kartonska škatla, ki vsebuje 30 x 1 perforiran pretisni omot za enkratni odmerek iz
ho • Cardboard box containing 60 x 1 PVC/ Aluminium perforated unit dose blisters (2 pouches)
nj PVC/ aluminija (1 vrečka) lje • Kartonska škatla, ki vsebuje 60 x 1 perforiran pretisni omot za enkratni odmerek iz PVC/ aluminija (2 vrečki) vo
ut • Cardboard box containing 90 x 1 PVC/ Aluminium perforated unit dose blisters (3 pouches)
• Kartonska škatla, ki vsebuje 90 x 1 perforiran pretisni omot za enkratni odmerek iz do
ra • Cardboard box containing 180 x 1 PVC/ Aluminium perforated unit dose blisters (6 pouches)
• Kartonska škatla, ki vsebuje 180 x 1 perforiran pretisni omot za enkratni odmerek iz ā
• Cardboard box containing 270 x 1 PVC/ Aluminium perforated unit dose blisters (9 pouches)
• Kartonska škatla, ki vsebuje 270 x 1 perforiran pretisni omot za enkratni odmerek iz PVC/ aluminija (9 vrečk) a
• ge Cardboard box containing 60 x 1 PVC/ Aluminium perforated unit dose blisters (2 pouches) and 2 spare Insulin Release Units (IRU) n lo • Cardboard box containing 270 x 1 PVC/ Aluminium perforated unit dose blisters (9 pouches) and 6 spare Insulin Release Units (IRU) o tn
PVC/ aluminija (9 vrečk) in 6 rezervnih nastavkov za sproščanje insulina (Insulin release unit - IRU) vi
• A kit containing 90 x 1 PVC/ Aluminium perforated unit dose blisters (3 pouches), 1 insulin inhaler, 1 spare chamber and 6 spare Insulin Release Units (IRU) uc
• Komplet, ki vsebuje 90 x 1 perforiran pretisni omot za enkratni odmerek iz PVC/ aluminija ra
Additional insulin inhaler, insulin release units and chamber packages are available. od
(3 vrečke), 1 insulinski inhalator, 1 rezervno komoro in 6 rezervnih nastavkov za sproščanje insulina (Insulin release unit - IRU) Zd
Not all pack sizes may be marketed. pr
Na trgu ni vseh navedenih pakiranj.
6.6 Special precautions for disposal and other handling
16 6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
EXUBERA unit dose blisters must only be used with the insulin inhaler. al in
Enoodmerni pretisni omoti zdravila EXUBERA se smejo uporabljati samo z insulinskim inhalatorjem.
The insulin inhaler should be replaced annually. ic
Insulinski inhalator je treba zamenjati enkrat na leto.
The Insulin Release Unit (IRU) should be replaced once every 2 weeks. ed
Nastavek za sproščanje insulina (Insulin release unit - IRU) je treba zamenjati enkrat na 2 tedna.
If the insulin inhaler is inadvertently exposed to extremely moist conditions during use this usually leads to a subsequent decreased insulin dose delivered from the inhaler.
et Če je insulinski inhalator med uporabo po nepazljivosti izpostavljen izredno vlažnemu okolju, to najverjetneje povzroči, da sprosti manjši odmerek insulina.
In this case, the Insulin M
V takšnem primeru je treba nastavek za
Release Unit (IRU) must be changed prior to the next inhalation (see section 4.4).
om sproščanje insulina (Insulin release unit - IRU) pred naslednjo inhalacijo zamenjati (glejte poglavje 4. 4).
16 7.
pr 7.
Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13, 9NJ United Kingdom
za Pfizer Limited Ramsgate Road, Sandwich, Kent,
8.
nj lje 8.
ed EU/ 1/ 05/ 327/ 001 EU/ 1/ 05/ 327/ 002
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET vo EU/ 1/ 05/ 327/ 001 EU/ 1/ 05/ 327/ 002 do
ris EU/ 1/ 05/ 327/ 003 EU/ 1/ 05/ 327/ 004
EU/ 1/ 05/ 327/ 003 EU/ 1/ 05/ 327/ 004 EU/ 1/ 05/ 327/ 005 EU/ 1/ 05/ 327/ 006 ā
ho EU/ 1/ 05/ 327/ 005 EU/ 1/ 05/ 327/ 006 EU/ 1/ 05/ 327/ 007
EU/ 1/ 05/ 327/ 007 ve
ut EU/ 1/ 05/ 327/ 008
EU/ 1/ 05/ 327/ 008 a
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET m
DATE OF REVISION OF THE TEXT o tn uc od pr al in ic ed M
DATUM ZADNJE REVIZIJE BESEDILA lo vi ra Zd
EXUBERA 3 mg inhalation powder pre-dispensed.
2.
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. uc
EXUBERA je indicirana za zdravljenje odraslih bolnikov z diabetesom mellitusom tipa 2, ki ni ustrezno urejen s peroralnimi antidiabetiki in potrebujejo insulinsko terapijo. ā
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 od
EXUBERA je indicirana tudi kot dodatek dolgo - ali srednjedolgo - delujočemu subkutanemu insulinu ve
adding inhaled insulin outweigh the potential safety concerns (see section 4.4). pr
za zdravljenje odraslih bolnikov z diabetesom mellitusom tipa 1, pri katerih možne koristi dodanega inhaliranega insulina prevladajo nad možnimi tveganji (glejte poglavje 4. 4). a
4.2 Posology and method of administration
4. 3 Odmerjanje in način uporabe m
Inhaled human insulin may be used alone or in combination with oral antidiabetic agents and/ or long or intermediate acting subcutaneously administered insulins to optimise glycaemic control. in ic
Humani insulin za inhaliranje lahko uporabljamo samega ali v kombinaciji s peroralnimi antidiabetiki in/ ali dolgo - ali srednjedolgo - delujočemi subkutano apliciranimi insulini za optimizacijo glikemične kontrole. lo vi
18 Daily doses and timing of administration
18 Začetno in nadaljne odmerjanje (odmerek in časovni razpored jemanja zdravila) mora zdravnik določiti za vsakega bolnika posebej in ju prilagoditi bolnikovemu individualnemu odzivu in potrebam (npr. dieti, telesni aktivnosti in načinu življenja).
Approximate guidelines for initial, pre-meal EXUBERA doses, based on patient body weight, are indicated in Table 1:
om Okvirne smernice za začetne odmerke zdravila EXUBERA, aplicirane pred obroki, na podlagi bolnikove telesne masa, kaže preglednica 1:
ed
pr
ris
30 40
ho
a
ra Table 1:
Preglednica 1:
Approximate Guidelines for Initial, Pre-Meal EXUBERA Dose (based on patient
Okvirne smernice za začetno odmerjanje EXUBERE pred obroki (na podlagi bolnikove telesne teže). do
A 1 mg blister of inhaled insulin is approximately equivalent to 3 IU of subcutaneously injected fast- n acting human insulin.
1- mg pretisni omot inhaliranega insulina ustreza približno 3 i. e. subkutano injiciranega hitrodelujočega humanega insulina.
A 3 mg blister of inhaled insulin is approximately equivalent to 8 IU of lo subcutaneously injected fast-acting human insulin.
Preglednica 1 ā
Table 1 above presents the approximate IU dose of fast-acting human insulin for initial, pre-meal EXUBERA doses in mg. o tn
prikazuje približno enakovreden odmerek v i. e. hitrodelujočega humanega insulina za začetne ve
Therefore, EXUBERA should be used with caution in patients of low body weight.
EXUBERE ni a
The use of EXUBERA in patients requiring dose titrations of less than 1 mg is not recommended (see section 4.4). uc
priporočljivo uporabljati pri bolnikih, ki potrebujejo prilagoditve odmerka, manjše od 1 mg (glejte poglavje 4. 4). m
Dose adjustment may be required based on the meal size and nutrient composition, time of day od
Prilagoditev odmerka utegne biti potrebna na podlagi velikosti obroka in hranilni sestavi, dnevnega ni
(higher insulin requirements in the morning), pre-meal blood glucose concentration, recent or anticipated exercise. pr
časa (večje potrebe po insulinu zjutraj), koncentracije glukoze v krvi pred obrokom, nedavne ali predvidene telesne aktivnosti. lo
During intercurrent respiratory illness (e. g. bronchitis, upper respiratory tract infections) close monitoring of blood glucose concentrations and dose adjustment may be required on an individual al
Med interkurentno boleznijo dihal (npr. bronhitis, infekcije zgornjih dihal) utegne biti potrebno vi
basis (see section 4.4). in
natančno spremljanje koncentracij glukoze v krvi in prilagajanje odmerka na individualni podlagi (glejte poglavje 4. 4). ra
For further details on how to use the insulin inhaler refer to the instructions for use (IFU). ic
Za nadaljnje podrobnosti o načinu uporabe insulinskega inhalatorja glejte navodila za uporabo Zd
Hepatic and renal impairment ed
Okvare jeter in ledvic
M
Pri bolnikih z okvaro jeter ali ledvic utegnejo biti potrebe po insulinu zmanjšane.
Children and adolescents
19 Otroci in mladostniki
19 Congestive heart failure
et Kongestivno srčno popuščanje
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
za Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov.
Hypoglycaemia.
a Hipoglikemija.
ed Patients must not smoke during therapy with EXUBERA and must have stopped smoking at least 6 months prior to starting EXUBERA therapy.
nj Med zdravljenjem z zdravilom EXUBERA bolniki ne smejo kaditi, v poštev za zdravljenje s tem lje zdavilom pridejo samo bolniki, ki so prenehali kaditi vsaj 6 mesecev pred začetkom zdravljenja.
If a patient starts or resumes smoking, EXUBERA must
Če bolnik začne ali spet začne kaditi, je treba zdravilo EXUBERA zaradi zvečanega tveganja hipoglikemije nemudoma ukiniti in uporabiti alternativno zdravljenje (glejte poglavje 5. 2). vo
ho Poorly controlled, unstable, or severe asthma.
Slabo urejena, nestabilna ali huda astma. do
ut Severe (GOLD stage III or IV) Chronic obstructive pulmonary disease (COPD).
Huda kronična obstruktivna pljučna bolezen (KOPB) (stadij III ali IV po GOLD). ā
ra 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi ve
ge Patients started on EXUBERA must receive comprehensive instructions in the use of the inhaler (see IFU).
Bolniki, ki jih začnete zdraviti z zdravilom EXUBERA, morajo prejeti izčrpna navodila o uporabi insulinskega inhalatorja (glejte Navodilo za uporabo insulinskega inhalatorja).
Patients should inhale the insulin powder from the mouthpiece in one slow and steady n inhalation.
Bolniki morajo vdihniti insulinski prašek iz ustnika v enem samem počasnem in enakomernem vdihu.
Patients should then hold their breath for 5 seconds and exhale normally.
dih za 5 sekund in normalno izdihnejo.
A consistent and standard inhalation technique should be employed to ensure both optimal and consistent drug lo delivery. o
Uporabljati morajo dosledno in standardno tehniko inhaliranja, m
Patients should avoid exposing the product to high moisture or relative humidity conditions e. g. a tn
s čimer bodo zagotovili tako optimalni kot vedno enak vnos zdravila. ni
steamy bathroom, when taking their dose.
Bolniki zdravila med uporabo ne smejo izpostaviti zelo vlažnemu okolju oz. okolju z veliko relativno vlažnostjo (npr. kopalnica, polna pare). lo
If the insulin inhaler is inadvertently exposed to extremely moist conditions during use this usually uc
Če je insulinski inhalator med uporabo po nepazljivosti izpostavljen izredno vlažnemu okolju, to vi
leads to a subsequent decreased the insulin dose delivered from the inhaler.
najverjetneje povzroči, da sprosti manjši odmerek insulina.
In this case, the Insulin Release Unit (IRU) must be changed prior to the next inhalation (see section 6.6). od
V takšnem primeru je treba nastavek za sproščanje insulina (Insulin release unit - IRU) pred naslednjo inhalacijo zamenjati (glejte poglavje ra
Dosing pr
Zd
Transferring a patient to another type or brand of insulin should be done under strict medical supervision as this may result in a change in dosage. al
Odmerjanje
Consecutive inhalation of three 1 mg unit dose blisters causes a significantly higher insulin exposure in
Prehod bolnika z ene vrste insulina na drugo mora potekati pod strogim zdravniškim nadzorstvom, kajti posledica je lahko spremenjeno odmerjanje.
Therefore three 1 mg unit dose blisters should not be ic
Izpostavljenost insulinu je po zaporedni inhalaciji treh 1- mg pretisnih omotov za enkratni odmerek bistveno večja kot po inhalaciji enega 3- mg pretisnega omota za enkratni odmerek.