FrancophonIA/ELRC3.0 huggingface dataset:
English: As with other insulins, hypoglycaemia was the most frequently observed undesirable effect in patients
Slovenian: Podobno kot pri drugih insulinih, je hipoglikemija najpogostejši neželeni učinek pri bolnikih,
English: Before travelling, consult your doctor or nurse to talk about timings of meals and insulin administration while travelling, the possible effects of changing to different time zones on blood sugar levels and control and the availability of EXUBERA in the countries you are visiting.
Slovenian: Pred potovanjem se posvetujte s svojim zdravnikom ali medicinsko sestro o urah dneva, ob katerih boste v času potovanja uživali obroke hrane in jemali insulin, o možnih posledicah prehoda v drug časovni pas na koncentracijo in kontrolo krvne glukoze in o tem, ali je v državah, ki jih boste obiskali, zdravilo EXUBERA na voljo.
English: Animal studies did not show that inhaled human insulin accumulates in the lung.
Slovenian: Študije na živalih niso pokazale, da bi se humani insulin za inhaliranje kopičil v pljučih.
English: Insulin treatment can cause the body to produce antibodies to insulin (substances that bind to insulin).
Slovenian: Zdravljenje z insulinom lahko povzroči, da telo začne izdelovati protitelesa (snovi, ki se vežejo na insulin) proti insulinu.
English: Do not open the blister containing EXUBERA.
Slovenian: Ne odpirajte folije pretisnega omota, ki vsebuje zdravilo EXUBERA.
English: 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.
Slovenian: Nekateri bolniki, ki so po prehodu z insulina živalskega izvora na humani insulin doživeli hipoglikemične reakcije, so poročali, da so bili zgodnji opozorilni simptomi hipoglikemije manj izraženi ali drugačni kot pri njihovem prejšnjem insulinu.
English: The insulin inhaler should be replaced annually.
Slovenian: Insulinski inhalator je treba zamenjati enkrat na leto.
English: 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 respiratory symptoms (see section 4.5).
Slovenian: 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).
English: While the chamber is removed from the base (see “Take your insulin inhaler apart”), hold the base in your hand with the grey button facing you.
Slovenian: Ko sta komora in podnožje razstavljena (glejte “Insulinski inhalator razstavite”), primite podnožje z roko tako, da je sivi gumb obrnjen proti vam.
English: The blue dot on the bottom of the chamber must be on the same side as the blue button.
Slovenian: Modra pika na dnu komore mora biti na
English: Poorly controlled, unstable, or severe asthma.
Slovenian: Slabo urejena, nestabilna ali huda astma.
English: Therefore, EXUBERA should be used with caution in patients of low body weight.
Slovenian: Zato je treba EXUBERO pri bolnikih z nizko telesno maso uporabljati previdno.
English: Marketing Authorisation Holder and Manufacturer The marketing authorisation holder is Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom.
Slovenian: Imetnik dovoljenja za promet in izdelovalec Imetnik dovoljenja za promet z zdravilom je Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13
English: Experience with inhaled insulin in patients with congestive heart failure is very limited and its use is therefore not recommended in such patients where lung function is significantly compromised.
Slovenian: Izkušnje z inhaliranim insulinom pri bolnikih s kongestivnim srčnim popuščanjem so zelo omejene in zato se njegova uporaba ne priporoča pri bolnikih, pri katerih je delovanje pljuč pomembno
English: Five blister cards are in a clear plastic (PET) thermoformed tray with a desiccant and covered with a clear plastic (PET) lid.
Slovenian: Pet ploščic s pretisnimi omoti je v prozornem plastičnem (PET) termooblikovanem podstavku s sušilnim sredstvom, pokrite so s pokrovčkom iz prozorne plastike (PET).
English: Hypoglycaemia may occur as a result of an excess of insulin relative to food intake, energy
Slovenian: Hipoglikemija se lahko pojavi zaradi presežka insulina glede na zaužito hrano, porabo energije ali
English: Importantly, the incidence of all-causality adverse events related to coronary artery disease, such as angina pectoris or myocardial infarction was not increased with the use of EXUBERA.
Slovenian: Pomembno je, da se incidenca neželenih dogodkov ne glede na vzrok, povezanih z boleznijo koronarnih arterij, na primer angino pektoris in miokardnim infarktom, ni povečala z uporabo EXUBERE.
English: In each case, it may be necessary to adjust your insulin dosage to avoid too low or too high blood sugar levels.
Slovenian: V vsakem primeru bo mogoče treba prilagoditi vaše odmerjanje insulina, da ne bo prišlo do prenizkih ali previsokih koncentracij krvnega sladkorja.
English: Mode of Action
Slovenian: Način delovanja
English: Before starting treatment your doctor will carry out a simple test on your lung function to decide whether EXUBERA is the right treatment for you.
Slovenian: Pred začetkom zdravljenja vam bo zdravnik s preprosto preiskavo izmeril delovanje pljuč, da se bo lahko odločil, ali je EXUBERA pravo zdravilo za vas.
English: -If you have missed a dose of insulin or if you have taken too low a dose, your blood sugar level may become too high.
Slovenian: - Če ste pozabili vzeti odmerek insulina ali če ste vzeli premajhen odmerek, utegne raven vašega krvnega sladkorja preveč zrasti.
English: 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.
Slovenian: Študije toksičnosti inhalacije pri podganah in opicah, ki so trajale do 6 mesecev dolgo, niso dale dokazov kakšne posebne nevarnosti za dihala zaradi insulinskega praška za inhaliranje.
English: In such situations, the management of your diabetes may require a lot of care and you may need to seek advice from your
Slovenian: V takih primerih bo urejanje vaše sladkorne bolezni zahtevalo veliko natančnost in se boste morali za nasvet obrniti na svojega zdravnika ali medicinsko
English: Hypoglycaemia can generally be corrected by immediate carbohydrate intake.
Slovenian: Hipoglikemijo lahko običajno popravimo s takojšnjim zaužitjem ogljikovih hidratov.
English: The efficacy and safety of inhaled human insulin in patients with baseline FEV1 < 70% predicted have not been established and the use of inhaled human insulin in this population is not recommended.
Slovenian: Učinkovitost in varnost humanega insulina za inhaliranje pri bolnikih z izhodiščnim FEV1 < 70 % nista bili določeni in uporaba humanega insulina za inhaliranje pri tej populaciji ni priporočljiva.
English: Please follow closely the instructions for dosage, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) as discussed with your doctor or nurse.
Slovenian: Natančno se ravnajte po navodilih za odmerjanje, spremljanje koncentracije glukoze (preiskave krvi in urina), prehrano in telesno aktivnost (fizično delo in vadba), o katerih ste se pogovorili s svojim
English: The raised dots can be felt even when the blister is already inserted for reassurance that the
Slovenian: Izbokline lahko otipate, tudi ko je pretisni omot že vstavljen, in se tako prepričate, da ste
English: Octreotide/lanreotide (used in special endocrine conditions) may change the need for insulin.
Slovenian: Oktreotid/lanreotid (uporablja se pri posebnih boleznih žlez z notranjim izločanjem) lahko spremeni potrebe po insulinu.
English: Severe hypoglycaemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death.
Slovenian: Težka hipoglikemija lahko povzroči nezavest in/ali konvulzije, začasno ali trajno okvaro delovanja
English: You should change your insulin inhaler once a year from the date you first use the inhaler.
Slovenian: Insulinski inhalator zamenjajte enkrat na leto, na datum, ko ste ga prvič uporabili.
English: Your doctor will decide how much EXUBERA you will initially need based on your weight and recommend any changes after that based on your diet and amount of exercise.
Slovenian: Vaš zdravnik bo na podlagi vaše telesne mase odločil, koliko zdravila EXUBERA boste v začetku potrebovali, in vam priporočil morebitne spremembe odmerjanja na podlagi vaše prehrane in količine
English: For use only with the insulin inhaler.
Slovenian: Uporabljati se sme samo z insulinskim inhalatorjem.
English: Unlike subcutaneous insulin preparations, the bioavailability of EXUBERA is not influenced by Body Mass Index.
Slovenian: Drugače kot velja za podkožne pripravke insulina, indeks telesne mase ne vpliva na biološko uporabnost EXUBERE.
English: 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
Slovenian: 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
English: These small treatment group differences resolved within 6 weeks upon discontinuation after 2 years of treatment (see sections 4.8 and 5.1).
Slovenian: Te majhne razlike med različno zdravljenimi skupinami so izzvenele v 6 tednih po prekinitvi 2 leti trajajočega zdravljenja (glejte poglavji 4.8 in 5.1).
English: Always make sure you have the correct strength and number of EXUBERA blisters available before taking your dose.
Slovenian: Vedno poskrbite za to, da imate na voljo zadostno število pretisnih omotov zdravila EXUBERA pravilne jakosti, preden vzamete odmerek.
English: Patients developing dyspnoea while treated with EXUBERA should be examined for pulmonary or cardiac causes.
Slovenian: Bolnike, ki se jim med zdravljenjem z EXUBERO pojavi dispneja, je treba pregledati glede pljučnih oz. srčnih vzrokov zanjo.
English: 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).
Slovenian: 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 3mg pretisnim omotom (glejte poglavja 2, 4.2 in 4.4).
English: - If you have further questions, please ask your doctor, diabetes nurse or pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom, medicinsko sestro za diabetike ali s
English: If any of these side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Slovenian: Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: 6.6 Special precautions for disposal and other handling EXUBERA unit dose blisters must only be used with the insulin inhaler.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Enoodmerni pretisni omoti zdravila EXUBERA se smejo uporabljati samo z insulinskim inhalatorjem.
English: A unit dose blister is the individual container in which the insulin powder is packaged and will be called a blister in the rest of this leaflet.
Slovenian: Enoodmerni pretisni omot je posamični vsebnik, v katerem je pakiran insulinski prašek, in ga bomo v nadaljevanju tega navodila imenovali pretisni omot.
English: A number of substances affect glucose metabolism and may require dose adjustment of insulin.
Slovenian: Številne snovi vplivajo na presnovo glukoze, tako da utegne zaradi njih biti potrebna prilagoditev odmerka insulina.
English: In contrast, exposure to other people's cigarette smoke may decrease the amount of insulin your body
Slovenian: V nasprotju s tem lahko izpostavljenost dimu cigaret, ki jih kadijo drugi, zmanjša količino insulina, ki
English: • If you are allergic to insulin, the active ingredient contained in EXUBERA or any of the other ingredients of EXUBERA.
Slovenian: - če ste preobčutljivi za (alergični na) insulin, zdravilno učinkovino v zdravilu EXUBERA, ali katerokoli sestavino zdravila EXUBERA.
English: Inadequate dosage or discontinuation of treatment especially in insulin-dependant diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.
Slovenian: Nezadostno odmerjanje ali prekinitev zdravljenja, posebno pri diabetikih, odvisnih od insulina, lahko povzroči hiperglikemijo in diabetično ketoacidozo, ki lahko povzročita smrt.
English: 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 approximately 17 and 30%, respectively (see section 4.5).
Slovenian: Ko so zdravilo EXUBERA dajali zdravim prostovoljcem po dveurni pasivni izpostavljenosti cigaretnemu dimu v kontroliranih eksperimentalnih razmerah, sta se AUC in Cmax insulina zmanjšala za približno 17 oziroma 30 % (glejte poglavje 4.5).
English: INFORMATION IN BRAILLE EXUBERA 1 mg
Slovenian: INFORMACIJE V BRAILLOVI PISAVI Exubera 1 mg
English: For any information about this medicine, please contact the local EXUBERA Customer Care Centre.
Slovenian: Za kakršnekoli informacije o tem zdravilu se obrnite na Center za svetovanje o zdravilu EXUBERA v
English: The Insulin Release Unit (IRU) should be replaced once every 2 weeks.
Slovenian: Nastavek za sproščanje (Insulin release unit - IRU) je treba zamenjati enkrat na 2 tedna.
English: The tray is sealed in a plastic foil pouch with a desiccant, which keeps the medicine dry and should not be eaten.
Slovenian: Podstavek je zavarjen v vrečki iz plastične folije in ima priloženo sušilno sredstvo; slednje ohranja zdravilo suho, in ga ne smete zaužiti.
English: Change from Baseline in FEV1 (L) ( Mean +/- SD)
Slovenian: Sprememba FEV1 (l) od izhodišča ( povprečje +/- SD)
English: - you have had diabetes for a long time - due to diabetes, you suffer from a certain type of nervous disease (autonomic neuropathy), - you have recently suffered hypoglycaemia (e.g. the day before) or if it develops slowly, - you have almost normal or, at least, greatly improved blood sugar levels, - you are taking or have taken certain other medicines (see section 2, “Taking other medicines”).
Slovenian: - imate sladkorno bolezen že dolgo časa, - imate zaradi sladkorne bolezni določeno vrsto bolezni živčevja (avtonomno nevropatijo), - ste pred nedavnim (npr. en dan prej) imeli hipoglikemijo ali če se le-ta razvija počasi, - imate skoraj normalne ali vsaj močno izboljšane koncentracije krvnega sladkorja, - jemljete ali ste jemali nekatera druga zdravila (glejte poglavje 2 “Jemanje drugih zdravil”).
English: 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.
Slovenian: 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
English: In subjects with diabetes and in subjects without diabetes, no apparent differences in absorption of inhaled human insulin were observed between men and women.
Slovenian: Pri osebah s sladkorno boleznijo in osebah brez nje niso opazili jasnih razlik med moškimi in ženskami glede absorpcije humanega insulina za inhaliranje.
English: No further information is available for the remaining 3 subjects who discontinued.
Slovenian: Za ostale tri bolnike, ki so prenehali sodelovati v študiji, nadaljnih informacij ni.
English: All patients initiated on EXUBERA should have a baseline lung function examination (e.g. spirometry to measure FEV1).
Slovenian: Vsi bolniki, ki začenjajo uporabljati EXUBERO, morajo opraviti izhodiščno preiskavo pljučne funkcije (npr. spirometrijo za določitev FEV1).
English: Of these patients, 5 exhibited a significant improvement in FEV1 following discontinuation of therapy and one subject did not decrease further from the end of study value.
Slovenian: Petim izmed teh se je funkcija FEV1 po prekinitvi terapije pomembno izboljšala, enemu bolniku pa se v primerjavi z vrednostjo ob prekinitvi sodelovanja v študiji ni več zmanjševala.
English: INFORMATION IN BRAILLE EXUBERA 3 mg
Slovenian: INFORMACIJE V BRAILLOVI PISAVI Exubera 3 mg
English: Patients must not smoke during therapy with EXUBERA and must have stopped smoking at least 6 months prior to starting EXUBERA therapy.
Slovenian: Med zdravljenjem z zdravilom EXUBERA bolniki ne smejo kaditi, v poštev za zdravljenje s tem zdavilom pridejo samo bolniki, ki so prenehali kaditi vsaj 6 mesecev pred začetkom zdravljenja.
English: One subject in the EXUBERA and one in the comparator group discontinued treatment due to chest pain.
Slovenian: En preiskovanec v skupini z zdravilom EXUBERA, in eden v skupini s primerjalnim zdravilom sta prekinila zdravljenje zaradi bolečine v prsih.
English: If at 6 months a decline of 15-20% or > 500ml from baseline lung function is observed, spirometry should be repeated after 3 months.
Slovenian: Če je po 6 mesecih opazno zmanjšanje za 1520 % ali 500 ml od izhodiščnega izvida, je treba spirometrijo ponoviti čez 3 mesece.
English: Insulin antibody levels were higher in patients with type 1 diabetes compared to type 2 diabetes and plateaued within 6-12 months of exposure in both groups.
Slovenian: Koncentracije insulinskih protiteles so bile višje pri bolnikih z diabetesom tipa 1 kot pri tistih z diabetesom tipa 2 in so pri obeh skupinah dosegle plato po 6-12 mesecih izpostavljenosti.
English: 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 the insulin requirement.
Slovenian: Hipoglikemija, ki je na splošno najpogostejši neželeni učinek zdravljenja z insulinom in tudi zdravljenja z zdravilom EXUBERA in številnimi peroralnimi antidiabetiki, se lahko pojavi, če je odmerek insulina prevelik glede na potrebo po njem.
English: Carry some information with you to show you are diabetic.
Slovenian: Pri sebi imejte nekaj, iz česar bo razvidno, da imate sladkorno bolezen.
English: 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.
Slovenian: Humani insulin znižuje glukozo v krvi in pospešuje anabolne učinke ter zmanjšuje katabolne učinke, zvečuje transport glukoze v celice in nastajanje glikogena v mišicah in jetrih ter izboljšuje izrabo piruvata.
English: Discontinuation of EXUBERA therapy after 2 years resulted in resolution of treatment group differences within 6 weeks (see sections 4.4 and 5.1).
Slovenian: Prekinitev zdravljenja z zdravilom EXUBERA po 2 letih je povzročila izginotje razlik med skupinama z različnima zdraviloma v 6 tednih (glejte poglavji 4.4 in 5.1).
English: What EXUBERA looks like and contents of the pack
Slovenian: Izgled zdravila EXUBERA in vsebina pakiranja
English: - The active substance is insulin human.
Slovenian: - Zdravilna učinkovina je humani insulin.
English: EXUBERA should be taken within 10 minutes before the start of a meal.
Slovenian: Zdravilo EXUBERA vzemite največ 10 minut pred začetkom obroka.
English: • If you have poorly controlled , unstable, or severe asthma.
Slovenian: - če imate slabo urejeno, nestabilno ali hudo astmo.
English: Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia.
Slovenian: Opustitev obroka ali nenačrtovana naporna telesna aktivnost lahko povzroči hipoglikemijo.
English: The use of a bronchodilator (reliever inhaler) for asthma or other airway conditions may cause a more pronounced fall in blood sugar in response to inhaled insulin (see section 2 “Do not take EXUBERA” and section 2 “Take special care with EXUBERA”).
Slovenian: Uporaba bronhodilatatorja (inhalator za olajšanje) za astmo ali druge bolezni dihal lahko povzroči izrazitejše znižanje krvnega sladkorja v odziv na inhalirani insulin (glejte poglavje 2 “Ne jemljite zdravila EXUBERA“ in “Bodite posebno pozorni pri uporabi zdravila EXUBERA”).
English: This may include a mix of 1 mg (green coloured) and 3 mg (blue coloured) blisters.
Slovenian: Ta lahko obsega mešanico 1-mg (zelenih) in 3-mg (modrih) pretisnih omotov.
English: If you are under 18 years of age, please speak to your doctor, as use of EXUBERA is not recommended for patients under 18 years of age.
Slovenian: Če ste mlajši od 18 let, se pogovorite z zdravnikom, ker uporabe zdravila EXUBERA pri bolnikih,
English: Dose adjustment may be required based on the meal size and nutrient composition, time of day (higher insulin requirements in the morning), pre-meal blood glucose concentration, recent or
Slovenian: Prilagoditev odmerka utegne biti potrebna na podlagi velikosti obroka in hranilni sestavi, dnevnega časa (večje potrebe po insulinu zjutraj), koncentracije glukoze v krvi pred obrokom, nedavne ali
English: It is important that you take the number of 1 mg and 3 mg blisters that your doctor recommends in the combination that he or she recommends.
Slovenian: Pomembno je, da vzamete toliko 1-mg in 3-mg pretisnih omotov v takšni kombinaciji, kot vam je priporočil zdravnik.
English: Hold the insulin inhaler upright with the blue button facing towards you.
Slovenian: Primite insulinski inhalator in ga držite navpično, modri gumb naj bo obrnjen proti vam.
English: Administration of EXUBERA 10 minutes prior to administration of salbutamol did not affect the bronchodilatory response to salbutamol in non-diabetic subjects with mild-moderate asthma.
Slovenian: Dajanje zdravila EXUBERA 10 minut pred dajanjem salbutamola ni vplivalo na bronhodilatacijski odziv na salbutamol pri nediabetičnih osebah z blago do zmerno astmo.
English: Oedema and refraction abnormalities of the eye
Slovenian: Edem in refrakcijske očesne nenormalnosti
English: Long-term safety of inhaled human insulin has not been established in paediatric patients with diabetes and its use is therefore not recommended in patients under 18 years of age (see section 5.2).
Slovenian: Pri pediatričnih bolnikih s sladkorno boleznijo niso dokazali dolgoročne varnosti humanega insulina za inhaliranje, zato ne priporočamo njegove uporabe pri bolnikih, mlajših od 18 let (glejte poglavje
English: It also promotes the uptake of amino acids into cells and promotes protein synthesis and enhances the uptake of potassium into cells.
Slovenian: Pospešuje tudi privzem aminokislin v celice in pospešuje sintezo beljakovin in zvečuje privzem kalija v celice.
English: Insulin treatment may also cause temporary build-up of water in the body with swelling in the calves and ankles.
Slovenian: Zdravljenje z insulinom lahko povzroči tudi začasno kopičenje vode v telesu z otekanjem meč in