natgillin/translations-raw huggingface dataset:
Also, if you experience breathing difficulties that you have not previously discussed with your doctor, you should discuss them before
Tudi če imate kakšne težave z dihanjem, o katerih se s svojim zdravnikom še niste pogovorili, to storite, še preden se začnete zdraviti z zdravilom EXUBERA.
Symptoms that may tell you that your blood sugar levels are too high: thirst, increased need to pass water, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heartbeat, and glucose and ketone bodies in urine may be signs of too high blood sugar.
Simptomi, ki vam povedo, da je koncentracija vašega krvnega sladkorja previsoka: žeja, zvečana potreba po uriniranju, utrujenost, suha koža, pordelost obraza, izguba teka, nizek krvni tlak, pospešen srčni utrip in glukoza in ketonska telesa v urinu so lahko znaki previsokega krvnega sladkorja.
For information on the treatment of hypoglycaemia, see the end of section 4 “Possible side effects”.
Za informacije o zdravljenju hipoglikemije glejte zadnji del poglavja 4 ”Možni neželeni učinki”.
Mistakes in dosage
Napake pri odmerjanju
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).
Pri nediabetičnih preiskovancih s KOPB se je absorpcija humanega insulina za inhaliranje zdela večja kot pri osebah brez KOPB (glejte poglavje 4.4).
EXUBERA is an inhalation powder, pre-dispensed, and is supplied as tear-off unit dose blisters marked with either ‘1 mg EXUBERA' with green ink or ‘3 mg EXUBERA' with blue ink.
Zdravilo EXUBERA je odmerjen prašek za inhaliranje, ki je na voljo v pretisnih omotih za enkratni odmerek; omoti imajo na eni strani oznako ‘1 mg EXUBERA', natisnjeno z zeleno barvo, ali ‘3 mg EXUBERA', natisnjeno z modro barvo.
Do not wipe the blister slot
Ne brišite reže za pretisni
The use of EXUBERA in patients requiring dose titrations of less than 1 mg is not recommended (see section 4.2).
EXUBERE ni priporočljivo uporabljati pri bolnikih, ki potrebujejo prilagoditve odmerka, manjše od 1 mg (glejte poglavje 4.2).
It inhibits glycogenolysis and gluconeogenesis, increases lipogenesis in the liver and adipose tissue and inhibits lipolysis.
Zavira glikogenolizo in glukoneogenezo, zvečuje lipogenezo v jetrih in maščevju in zavira lipolizo.
Slowly and deeply breathe in the insulin cloud
Počasi in globoko vdihnite insulinski oblaček skozi usta v enem samem vdihu.
After your dose Turn the mouthpiece back to its closed position.
Zasukajte ustnik nazaj v zaprti položaj.
WHAT EXUBERA IS AND WHAT IT IS USED FOR EXUBERA is an inhalation powder contained in blisters.
KAJ JE ZDRAVILO EXUBERA IN ZA KAJ GA UPORABLJAMO Zdravilo EXUBERA je prašek za inhaliranje, pakiran v pretisnih omotih.
Administration of salbutamol 30 minutes prior to EXUBERA in non-diabetic subjects with mildmoderate asthma resulted in an increase in insulin AUC and Cmax of between 25 and 51% compared to when EXUBERA was administered alone (see sections 4.2 and 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).
If you suspect an allergy to EXUBERA, speak to your doctor immediately.
Če posumite, da ste alergični na zdravilo EXUBERA, se o tem nemudoma pogovorite s svojim zdravnikom.
Turn the top of the IRU clockwise until the blue line points to the lock symbol on the top of the base.
Zasukajte vrh nastavka za sproščanje insulina v smeri urnega kazalca, dokler modra črta ne kaže proti simbolu zaklepanja na vrhu podnožja.
In general, to prevent hypoglycaemia you must eat more food and monitor your blood sugar.
Na splošno velja, da morate več jesti in spremljati svoj krvni sladkor, da preprečite hipoglikemijo.
Figure 4: 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
Slika 4: Povprečne spremembe serumskih koncentracij prostega insulina (µi.e./ml) po inhalaciji 4 mg humanega insulina ali subkutani injekciji 12 i.e. hitrodelujočega topnega humanega insulina pri debelih bolnikih s sladkorno boleznijo tipa 2.
Approximate guidelines for initial, pre-meal EXUBERA doses, based on patient body weight, are indicated in Table 1:
Okvirne smernice za začetne odmerke zdravila EXUBERA, aplicirane pred obroki, na podlagi bolnikove telesne masa, kaže preglednica 1:
Your doctor will prescribe your starting pre-meal dose of EXUBERA based on your body weight.
Zdravnik vam bo predpisal začetni odmerek zdravila EXUBERA glede na vašo telesno maso.
Substances that may enhance the blood-glucose lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic agents, angiotensin converting enzyme (ACE) inhibitors, monoamino oxidase (MAO) inhibitors, non-selective beta-blocking agents, salicylates and sulphonamide antibiotics.
Snovi, ki utegnejo zvečati hipoglikemični učinek in dovzetnost za hipoglikemijo, vključujejo peroralne antidiabetike, inhibitorje konvertaze angiotenzina (ACE), inhibitorje monoaminooksidaze (MAO), neselektivne blokatorje adrenergičnih receptorjev beta, salicilate in sulfonamidne antibiotike.
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.
V povprečju so te osebe EXUBERO prejemale 23 mesecev, vrednost FEV1 pa se je v povprečju zmanjšala za 21 % (razpon med 16-33 %).
Hypoglycaemia - As with all insulin therapy, the most common side effect with EXUBERA is hypoglycaemia (too low blood sugar).
Hipoglikemija - Tako kot vedno pri zdravljenju z insulinom je tudi pri zdravilu EXUBERA najpogostejši neželeni učinek hipoglikemija (prenizek krvni sladkor).
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 prospective exploratory 6 month study in subjects with type 1 diabetes, alterations in the glucose pharmacodynamics with inhaled human insulin were not observed.
V prospektivni eksploratorni 6-mesečni študiji na bolnikih z diabetesom tipa 1 niso našli dokazov za spremembe farmakodinamike glukoze pri uporabi humanega insulina za inhaliranje.
Bioavailability of inhaled human insulin relative to subcutaneously administered fast-acting human insulin was comparable to that of adult subjects with type 1 diabetes (see section 4.2).
Biološka uporabnost humanega insulina za inhaliranje glede na subkutano injicirani hitrodelujoči humani insulin je bila primerljiva s tisto pri odraslih bolnikih z diabetesom tipa 1 (glejte poglavje 4.2).
Table 1: Approximate Guidelines for Initial, Pre-Meal EXUBERA Dose (based on patient
Preglednica 1: Okvirne smernice za začetno odmerjanje EXUBERE pred obroki (na podlagi
The tray is sealed in a foil laminate pouch with a desiccant.
Podstavek je neprodušno zaprt v vrečki iz laminirane folije s sušilnim sredstvom.
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.
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, pomanjkljivi.
After opening the foil overwrap: Store below 25˚C.
Po odprtju prekrivne folije: shranjujte pri temperaturi do 25o C.
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).
Takšne reakcije na insulin ali na pomožne snovi so lahko na primer povezane z generaliziranimi kožnimi reakcijami, angioedemom, bronhospazmom, hipotenzijo in šokom in so lahko smrtno nevarne (glejte
Severe (GOLD stage III or IV) Chronic obstructive pulmonary disease (COPD).
Huda kronična obstruktivna pljučna bolezen (KOPB) (stadij III ali IV po GOLD).
Medicines that may cause your blood sugar to rise include corticosteroids (used to treat inflammatory conditions, except topical administration), danazol (used for the treatment of some female hormonal disorders), oral contraceptives (used for birth control), thyroid hormones (used for the treatment of malfunction of the thyroid gland), growth hormones (used in endocrine conditions), sympathomimetic agents (used for the treatment of asthma) and thiazides (used in special endocrine conditions).
Zdravila, ki lahko povzročijo zvišanje vašega krvnega sladkorja, vključujejo kortikosteroide (uporabljajo se za zdravljenje vnetnih stanj, razen pri lokalni uporabi), danazol (uporablja se za zdravljenje nekaterih ženskih hormonskih bolezni), peroralne kontraceptive (uporabljajo se za načrtovanje družine), ščitnične hormone (uporabljajo se za zdravljenje motenega delovanja žleze ščitnice), rastne hormone (uporabljajo se pri boleznih žlez z notranjim izločanjem), simpatikomimetike (uporabljajo se za zdravljenje astme) in tiazide (uporabljajo se pri posebnih boleznih žlez z notranjim
The use of EXUBERA in patients requiring dose titrations of less than 1 mg is not recommended (see section
EXUBERE ni priporočljivo uporabljati pri bolnikih, ki potrebujejo prilagoditve odmerka, manjše od 1 mg (glejte
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).
Talk to your doctor if you have any lung disease such as asthma, emphysema or chronic bronchitis.
Če imate kakšno pljučno bolezen, na primer astmo, emfizem ali kronični bronhitis, se pogovorite s svojim zdravnikom.
Inhaled human insulin is delivered by the pulmonary route.
Humani insulin za inhaliranje se absorbira skozi pljuča.
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).
In clinical 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.
V kliničnih preskusih so se insulinska protitelesa razvila pogosteje in povprečne koncentracije insulinskih protiteles so bile višje pri bolnikih, ki so prešli s subkutanega humanega insulina na zdravilo EXUBERA, kot pri bolnikih, ki so ostali na subkutanem humanem insulinu.
Therefore, the 3 mg blister is not interchangeable with three 1 mg blisters (see sections 4.2, 4.4 and 5.2).
Zato 3-mg pretisni omot ni zamenljiv s tremi 1-mg pretisnimi omoti (glejte poglavja 4.2, 4.4 in 5.2).
Additional insulin inhaler, insulin release units and chamber packages are available.
Na voljo so tudi dodatna pakiranja insulinskega inhalatorja, nastavkov za sproščanje insulina in insulinskih komor.
EXUBERA is used to reduce high blood sugar in adult patients with type 2 diabetes mellitus who
Zdravilo EXUBERA uporabljamo za zniževanje visokega krvnega sladkorja pri odraslih bolnikih z diabetesom mellitusom tipa 2, ki potrebujejo insulin.
Medicines that may cause your blood sugar to fall include diabetes tablets, angiotensin converting enzyme (ACE) inhibitors (used for the treatment of certain heart conditions, high blood pressure or elevated protein/albumin in the urine), monoamine oxidase (MAO) inhibitors (used for the treatment of depression), certain beta-blockers (used for the treatment of certain heart conditions and high blood pressure), salicylates (e.g. aspirin, used to relieve pain and lower fever) and
Zdravila, ki lahko povzročijo padec krvnega sladkorja, vključujejo tablete za zdravljenje sladkorne bolezni, zaviralce angiotenzinske konvertaze (ACE) (uporabljajo se za zdravljenje nekaterih bolezni srca, visokega krvnega tlaka ali zvišanih beljakovin/albuminov v urinu), zaviralce monoamin-oksidaze (MAO) (uporabljajo se za zdravljenje depresije), nekatere zaviralce adrenergičnih receptorjev beta (uporabljajo se za zdravljenje nekaterih bolezni srca in zvišanega krvnega tlaka), salicilate (npr. aspirin, ki se uporablja za lajšanje bolečin in zniževanje zvišane telesne temperature) in sulfonamidne
Mean Glucose Infusion Rate (GIR) Normalised to GIRmax for Each Subject Treatment When human insulin is inhaled, the onset of glucose lowering activity is within 10-20 minutes, the maximum effect is exerted approximately 2 hours after inhalation.
Po inhalaciji humanega insulina nastopi aktivnost zniževanja glukoze v 10-20 minutah, učinek je največji približno 2 uri po inhalaciji.
Do not store the insulin inhaler in the refrigerator or freezer.
Inhalatorja za insulin ne shranjujte v hladilniku in ga ne zamrzujte.
As part of this plan, the Marketing Authorisation Holder will provide health care professionals with educational materials for healthcare professionals and patients that are aimed at risk minimisation and will support safe and effective use for the product by the patient.
V okviru tega načrta bo imetnik dovoljenja za promet z zdravilom zdravnikom posredoval izobraževalna gradiva za zdravnike in bolnike.
Do not use three 1 mg blisters in place of one 3 mg blister, as this will give you a much higher dose of insulin.
Namesto enega 3-mg pretisnega omota ne smete uporabiti treh 1-mg pretisnih omotov, ker boste v tem primeru dobili veliko večji odmerek insulina.
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).
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).
6 of these discontinued subjects underwent follow-up pulmonary function testing.
Pri šestih bolnikih od tistih, s katerimi so sodelovanje v študiji prekinili, so s spremljanjem pljučne funkcije nadaljevali.
One blister card contains 6 perforated unit dose blisters (PVC/Aluminium).
Vsaka ploščica s pretisnimi omoti vsebuje 6 perforiranih pretisnih omotov za enratni odmerek (PVC/aluminij).
In older subjects with type 2 diabetes, inhaled human insulin was absorbed more rapidly than subcutaneously administered fast-acting human insulin.
Pri starejših bolnikih z diabetesom tipa 2 se je humani insulin za inhaliranje absorbiral hitreje kot subkutano injicirani hitrodelujoči humani insulin.
Development of such antibodies is seen more commonly in patients treated with EXUBERA compared to subcutaneous insulin.
Razvoj teh protiteles je bolj pogost pri bolnikih, ki so bili zdravljeni z zdravilom EXUBERA, kot s subkutanim insulinom.
Do not substitute three 1 mg blisters for one 3 mg blister.
Enega 3-mg pretisnega omota ne smete nadomestiti s tremi 1-mg.
Inhaled human insulin, like fast-acting insulin analogues, has a more rapid onset of glucose lowering activity compared to subcutaneously administered soluble human insulin.
Humani insulin za inhaliranje, podobno kot hitrodelujoči analogi insulina, ima hitrejši nastop aktivnosti zniževanja glukoze kot subkutano aplicirani hitrodelujoči humani insulin.
Your doctor may replace EXUBERA with an injectable insulin for your diabetes.
Zdravnik vam bo za zdravljenje diabetesa zdravilo EXUBERA morda nadomestil z insulinom za injiciranje.
The new IRU is now locked in place.
Sedaj je novi nastavek za sproščanje insulina pravilno nameščen na svojem mestu.
• A pack containing 30, 60, 90, 180 and 270 x 1 of 1 mg PVC/Aluminium perforated unit dose
• pakiranje, ki vsebuje 30, 60, 90, 180 in 270 x 1 1-mg perforiran pretisni omot za enkratni
Your insulin dosage may need to be changed during pregnancy and after giving birth.
Med nosečnostjo in po porodu bo vaše odmerjanje insulina morda potrebno spremeniti.
Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in
Ko se bolniku vrne zavest, je priporočljivo peroralno zaužitje ogljikovih hidratov, s čimer preprečimo
With one hand, squeeze the two chamber release Buttons at the same time on the side of the base while pulling the base all the way out of the
Z eno roko stisnite oba gumba za sprostitev komore, ki sta ob straneh spodnjega dela inhalatorja, in hkrati z drugo roko povlecite
Patients should avoid exposing the product to high moisture or relative humidity conditions e.g. a 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).
See
Kako
• A pack containing 30, 60, 90, 180 and 270 x 1 of 3 mg PVC/Aluminium perforated unit dose
• pakiranje, ki vsebuje 30, 60, 90, 180 in 270 x 1 3-mg perforiran pretisni omot za enkratni
There is no experience with EXUBERA in patients with pneumonia.
Z uporabo EXUBERE pri bolnikih s pljučnico ni izkušenj.
Use of inhaled human insulin is associated with an increase in frequency, and levels of insulin antibodies.
Uporaba humanega insulina za inhaliranje se kaže z zvečanjem pogostnosti in koncentracije protiteles.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton/Unit dose blisters (30, 60, 90, 180 and 270)
PODATKI NA ZUNANJI OVOJNINI Škatla / enoodmerni pretisni omoti (30, 60, 90, 180 in 270)
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Washout Phase
Faza spiranja
• If you have severe (GOLD stage III or IV), Chronic Obstructive Pulmonary Disease (COPD).
- če imate hudo kronično obstruktivno pljučno bolezen (KOPB) (stadij III ali IV po GOLD).
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
Pri bolnikih z diabetesom tipa 1 ali tipa 2 ima humani insulin za inhaliranje hitrejši nastop učinka glede zniževanja glukoze v prvih urah po odmerku kot subkutano injicirani hitrodelujoči humani
Inhaled Insulin Subcutaneous Insulin
nastavek za sproščanje insulina insulinski pretisni omot
If you temporarily run out of 3 mg blisters, two 1 mg blisters should be used and you should monitor your blood glucose levels closely.
Če vam začasno zmanjka 3-mg pretisnih omotov, vzemite dva 1-mg pretisna omota in natančno spremljajte svoj krvni sladkor.
Respiratory
Dihala
In this case, the Insulin Release Unit (IRU) must be changed prior to the next inhalation (see section 4.4).
V takšnem primeru je treba nastavek za sproščanje insulina (Insulin release unit - IRU) pred naslednjo inhalacijo zamenjati (glejte poglavje
Keep this leaflet.
Glejte sliko.
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 injiciranem hitrodelujočem humanem insulinu.
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.
Humani insulin za inhaliranje lahko uporabljamo samega ali v kombinaciji s peroralnimi antidiabetiki in/ali dolgo- ali srednjedolgo- delujočemi subkutano apliciranimi insulini za
A follow-up lung function measurement is recommended after the first 6 months of therapy.
Po prvih 6 mesecih zdravljenja je priporočljiva ponovna ocena pljučne funkcije.
Do not use three separate 1 mg blisters in place of one 3 mg blister, as this will give you a much higher insulin dose (see “How to take EXUBERA” for further advice).
Namesto enega 3-mg pretisnega omota ne smete uporabiti treh ločenih 1-mg pretisnih omotov, ker boste v tem primeru dobili veliko večji odmerek insulina (za dodatna navodila glejte ”Kako uporabljati zdravilo EXUBERA“).
Line up the blue line on the top of the IRU with the unlock symbol on the top of the base.
Poravnajte modro črto na vrhu nastavka za sproščanje insulina s simbolom odklepanja na
If 3 mg blisters are unavailable, use only two 1 mg blisters as replacement.
Če nimate na voljo 3-mg pretisnega omota, namesto njega uporabite le dva 1-mg.
To use an EXUBERA blister, first separate the blister from the spine by tearing along the tear line
Pred uporabo pretisnega omota zdravila EXUBERA omot najprej ločite od hrbtišča tako, da ga
QUALITATIVE AND QUANTITATIVE COMPOSITION Each unit dose blister contains 3 mg insulin human.
KAKOVOSTNA IN KOLIČINSKA SESTAVA En enoodmerni pretisni omot vsebuje 3 mg humanega insulina.
Squeeze the handle until it snaps shut.
Stisnite ročico, da se bo s tleskom zaprla.
You should avoid taking EXUBERA in moist conditions e.g. a bathroom following a steamy shower as this will usually give you a lower insulin dose than you need (see “Instructions for Use” at the end
Zdravila EXUBERA ne smete uporabljati v vlažnem okolju, npr. v kopalnici po prhi, ki povzroči veliko pare, saj boste zaradi tega v telo najverjetneje vnesli manjši odmerek insulina, kot ga potrebujete (za nasvet glejte “Navodilo za uporabo insulinskega inhalatorja” na koncu tega navodila).
One percent of patients discontinued EXUBERA
En odstotek bolnikov je prekinil zdravljenje z zdravilom EXUBERA zaradi kašlja.
For Cmax, the intrasubject variability of inhaled insulin is greater than that of subcutaneously administered fastacting human insulin.
Intraindividualna variabilnost Cmax inhaliranega insulina je večja kot subkutano apliciranega hitrodelujočega humanega insulina.
For further details on how to use the insulin inhaler refer to the instructions for use (IFU).
Za nadaljnje podrobnosti o načinu uporabe insulinskega inhalatorja glejte navodila za uporabo Navodilo za uporabo insulinskega inhalatorja).
Small treatment group differences in decline of FEV1 were observed in the EXUBERA group relative to comparator therapy.
V skupini z zdravilom EXUBERA so v primerjavi s skupino, zdravljeno s primerjalnim zdravilom, opazili majhne razlike v zmanjšanju FEV1 .
For instructions on how to look after your insulin inhaler see “Instructions for Use” at the end of the package leaflet.
Navodila o tem, kako skrbeti za insulinski inhalator, boste našli v “Navodilu za uporabo insulinskega inhalatorja”, ki se nahaja na koncu tega navodila.
If the 3 mg blister is temporarily unavailable, two 1 mg blisters should be substituted and blood glucose monitored closely.
Če bolnik trenutno nima na voljo 3-mg pretisnega omota, naj uporabi dva 1-mg pretisna omota in naj natančno nadzira glukozo v krvi.
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 improvements in HbA1c compared with patients treated with oral agents alone.
V kliničnih preskušanjih na bolnikih z diabetesom tipa 2, pri katerih glikemična kontrola samo s peroralnimi antidiabetiki ni zadostna, se je HbA1c bolj izboljšal pri bolnikih, zdravljenih s shemami z zdravilom EXUBERA samim ali v kombinaciji s peroralnimi antidiabetiki, kot pri bolnikih, zdravljenih samo s peroralnimi antidiabetiki.
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
Bolniki z diabetesom tipa 2, ki so v kliničnem preskušanju uporabljali shemo z zdravilom EXUBERA v kombinaciji z dolgo- ali srednjedolgo-delujočim insulinom, so imeli podobne spremembe HbA1c kot bolniki, zdravljeni samo s subkutanim insulinom.