natgillin/translations-raw huggingface dataset:
Please discuss with your doctor what you should do if you were to take too much or too little EXUBERA, or if you miss a dose, so that you know what to do. 
Pogovorite se s svojim zdravnikom o tem, kaj je treba storiti, če vzamete preveč ali premalo zdravila EXUBERA ali če pozabite vzeti en odmerek, tako da boste v takšnem primeru vedeli, kaj morate storiti.
In clinical studies of up to two years duration, there was no accelerated decline beyond 3-6 months. 
V kliničnih študijah, ki so trajale do dve leti dolgo, od 3. do 6. meseca naprej ni bilo pospešenega zmanjševanja.
It is advisable to test your blood sugar immediately after taking glucose to check that you really have 
Priporočljivo je, da si takoj po zaužitju glukoze testirate krvni sladkor, da preverite, ali imate res
If you are not able to swallow or if you are unconscious, you will require an injection of glucose or glucagon (a medicine which increases blood sugar). 
Če ne morete požirati ali če ste nezavestni, boste potrebovali injekcijo glukoze ali glukagona (zdravilo, ki zviša krvni sladkor).
More severe episodes, with coma, seizure, or neurological impairment may be treated with intramuscular/subcutaneous glucagon (0.5 to 1 mg) or concentrated intravenous glucose. 
Težje epizode s komo, napadi krčev ali nevrološkimi okvarami lahko zdravimo z intramuskularnim/subkutanim glukagonom (0,5 do 1 mg) ali koncentrirano intravensko glukozo.
If you are taking EXUBERA, do not smoke (see section 2, “Do not take 
Če uporabljate zdravilo EXUBERA, ne smete kaditi (glejte poglavje 2 “Ne jemljite
All patients who were diagnosed with lung cancer had a prior history of cigarette smoking. 
Vsi bolniki, pri katerih so odkrili raka pljuč, so imeli anamnezo kajenja cigaret.
The first symptoms which alert you to hypoglycaemia (“warning symptoms”) may change, be weaker 
Prvi simptomi, ki vas opozorijo na hipoglikemijo (“opozorilni simptomi”), se lahko spremenijo,
Symptoms of hypoglycaemia usually occur suddenly. 
Simptomi hipoglikemije se navadno pojavijo nenadoma.
Note: 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. 
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.
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. 
Pred potovanjem skozi različne časovne pasove je treba bolniku svetovati, naj se posvetuje z zdravnikom, ker utegne to pomeniti, da bo moral bolnik jemati insulin in uživati dnevne obroke ob
Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or operating machinery). 
Ne pozabite na možnost te težave v vsakem položaju, ko bi lahko spravili v nevarnost sebe ali druge (na primer pri upravljanju avtomobila ali uporabi strojev).
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 
Kajenje močno poveča delež in obseg absorpcije humanega insulina za inhaliranje (Cmax je za 3- do 5krat večja, AUC za 2- do 3- krat večja) in bi zato lahko povečalo tveganje za hipoglikemijo (glejte
If you notice an immediate and severe worsening of your breathing soon after taking a dose of EXUBERA, you should stop taking EXUBERA and tell your doctor immediately or go to the casualty 
Če opazite takojšnje in izrazito poslabšanje dihanja kmalu po tistem, ko ste vzeli odmerek zdravila EXUBERA, morate zdravilo prenehati jemati in to nemudoma povedati svojemu zdravniku ali oditi na
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. 
Prehod bolnika z ene vrste insulina na drugo mora potekati pod strogim zdravniškim nadzorstvom, kajti posledica je lahko spremenjeno odmerjanje.
Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis) resulting from lack of insulin. 
Bolečine v želodcu, pospešeno in globoko dihanje, zaspanost ali celo izguba zavesti so lahko znaki težkega stanja (ketoacidoze), ki ga povzroči pomanjkanje insulina.
Re-administration of EXUBERA requires a careful risk evaluation, and may only be done under close medical monitoring with appropriate clinical facilities. 
Pri ponovni uporabi zdravila EXUBERA je potrebno skrbno ovrednotenje tveganja, zdravilo se sme ponovno uvesti samo ob strogem zdravniškem nadzoru in ustreznih medicinskih kapacitetah.
Please speak to your doctor immediately if you take EXUBERA and resume smoking or have smoked in the last 6 months 
Prosimo, da se nemudoma pogovorite s svojim zdravnikom, če jemljete zdravilo EXUBERA in ste spet začeli kaditi ali ste kadili v zadnjih 6 mesecih pred začetkom jemanja zdravila
EXUBERA is often given in combination with other diabetes treatments. 
Zdravilo EXUBERA se pogosto daje v kombinaciji z drugimi zdravili za zdravljenje sladkorne
Other drugs that may alter pulmonary absorption or lung permeability have not been studied. 
Drugih zdravil, ki utegnejo zmanjšati absorpcijo skozi pljuča ali pljučno permeabilnost, niso proučevali.
In children (6-11 years) and adolescents (12-17 years) with type 1 diabetes, inhaled human insulin was absorbed more rapidly than fast-acting human insulin. 
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.
The starting and subsequent dosage (dose and timings) should be determined individually by the physician and adjusted according to the patient's individual response and requirements (e.g. diet, physical activity and life-style). 
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).
The cough is usually mild and often gets better over time. 
Kašelj je navadno blag in se sčasoma pogosto ublaži.
Do not use EXUBERA if you notice that a blister is not properly sealed or damaged. 
Ne uporabite zdravila EXUBERA, če opazite, da pretisni omot ni pravilno zaprt ali da je poškodovan.
Press the grey button and pull out the insulin 
Pritisnite sivi gumb in izvlecite insulinski pretisni
Then eat something that has a long-acting effect in raising your blood sugar (e.g. bread). 
Nato pojejte nekaj, kar vam bo za dalj časa zvišalo krvni sladkor (npr. kruh).
Body System Very Common 
Telesni sistem zelo pogosti pogosti občasni
FEV1 reversibility 
Reverzibilnost FEV1
Please see the end of this section for important further information about hypoglycaemia and its treatment. 
Prosimo glejte zadnji del tega poglavja, kjer boste našli pomembne nadaljnje informacije o hipoglikemiji in njenem zdravljenju.
If you smoke, the amount of insulin your body absorbs will be increased and you will have a greater risk of hypoglycaemia. 
Če kadite, se bo povečala količina insulina, ki se absorbira v telesu, in tako bo večja tudi nevarnost hipoglikemije.
Turn the mouthpiece to the open position. 
Zasukajte ustnik v odprti položaj.
Test your blood sugar level and your urine for ketones as soon as any such symptoms of hyperglycaemia occur as described above. 
Testirajte si raven krvnega sladkorja in urin na ketone, takoj ko se pojavi eden ali več zgoraj opisanih simptomov hiperglikemije.
If the washed chamber is not dry prior to taking your next dose, use your spare chamber. 
Če se oprana komora do takrat, ko morate vzeti naslednji odmerek, ne posuši, uporabite rezervno
A consistent and standard inhalation technique should be employed to ensure both optimal and consistent drug 
Uporabljati morajo dosledno in standardno tehniko inhaliranja, s čimer bodo zagotovili tako optimalni kot vedno enak vnos zdravila.
As with other insulins, the patient's ability to concentrate and react may be impaired as a result of hypoglycaemia. 
Podobno kot pri drugih insulinih se lahko bolnikova sposobnost za koncentriranje in odzivanje zaradi hipoglikemije zmanjša.
Although these antibodies may be produced, they do not have any effect on your blood glucose control. 
Ta protitelesa sicer lahko nastajajo, vendar nimajo nikakršnega vpliva na uravnavanje vaše ravni glukoze v krvi.
Comparator N=145, 143, 125, 129, 120. 
Primerjano zdravilo N=145, 143, 125, 129, 120.
There are no fixed rules for insulin dosage. 
Za odmerjanje insulina ni trdnih pravil.
The percentage of patients who achieved a goal of HbA1c < 7.0% was comparable between the treatment groups. 
Odstotni delež bolnikov, ki so dosegli ciljno vrednost HbA1c < 7,0 %, je bil primerljiv pri obeh zdravljenih skupinah.
This cough decreased over time. 
Ta kašelj je sčasoma postajal manj izrazit.
Make sure that you can use the inhaler properly as this could affect the 
Vsekakor poskrbite, da boste znali inhalator pravilno uporabljati, ker bi to lahko vplivalo na količino insulina, ki
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 airways and 40% reaches the deep lung. 
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 dihalnih poteh, 40 % pa doseže globoke predele pljuč.
After the cloud appears, immediately turn the mouthpiece around. 
Ko se pojavi oblaček, nemudoma zasukajte ustnik, ki naj bo sedaj obrnjen proti vam.
Due to the rapid onset of activity, inhaled human insulin should be given within 10 minutes before the start of a meal. 
Zaradi hitrega nastopa delovanja morate humani insulin za inhaliranje dajati največ 10 minut pred začetkom obroka.
Insulin antibodies may develop during treatment with all insulins including EXUBERA. 
Insulinska protitelesa se lahko pojavijo med zdravljenjem z vsemi insulini, vključno z zdravilom EXUBERA.
Visit (weeks) 
čas (min)
Any patients experiencing such a reaction should discontinue EXUBERA and seek medical evaluation immediately. 
Bolniki, pri katerih bi se pojavila takšna reakcija, naj prekinejo z jemanjem zdravila EXUBERA in si takoj priskrbijo zdravniški pregled.
Cough - A cough may occur within seconds to minutes after inhaling EXUBERA. 
Kašelj - Kašelj se lahko pojavi v nekaj sekundah ali nekaj minutah po inhaliranju zdravila EXUBERA.
Do not use soap or any other cleanser. 
Ne uporabljajte detergenta ali kakšnega drugega čistila.
You should contact your doctor or pharmacist as soon as possible to get more 3 mg blisters. 
Čimprej pojdite k zdravniku ali farmacevtu, da boste dobili nove 3-mg pretisne omote.
Patients should inhale the insulin powder from the mouthpiece in one slow and steady inhalation. 
Bolniki morajo vdihniti insulinski prašek iz ustnika v enem samem počasnem in enakomernem vdihu.
Before you start taking EXUBERA your doctor or nurse will tell you how to use the inhaler properly. 
Preden začnete jemati zdravilo EXUBERA, vam bosta vaš zdravnik ali medicinska sestra pokazala, kako pravilno uporabljati inhalator.
The table below contains adverse reactions seen in controlled clinical studies including more than 1970 patients exposed to EXUBERA. 
Spodnja preglednica vsebuje neželene učinke, ki so jih opazili v kontroliranih kliničnih študijah, ki so zajele več kot 1970 bolnikov, izpostavljenih zdravilu EXUBERA.
-If you have taken too much insulin, you may develop hypoglycaemia. 
- Če ste vzeli preveč insulina, se pri vas lahko razvije hipoglikemija.
(If the new IRU does not drop into place or fits tightly, remove 
(Če novi nastavek za sproščanje insulina ne zdrsne na mesto ali če se preveč tesno prilega, ga izvlecite in poskusite
• If you smoke, or if you have smoked in the last six months you must not take EXUBERA as you may have extra risk of hypoglycaemia (very low blood sugar). 
- če kadite ali če ste v zadnjih šestih mesecih kadili, zdravila EXUBERA ne smete jemati, ker utegne biti pri vas še posebno velika nevarnost hipoglikemije (nizkega krvnega sladkorja).
EXUBERA is an anti-diabetic agent that lowers your blood sugar. 
EXUBERA je antidiabetično zdravilo, ki znižuje vaš krvni sladkor.
The inhaler and its components should be stored and used in a dry place. 
Inhalator in njegove sestavne dele shranjujte in uporabljajte na suhem.
Alcohol may increase the action of insulin and cause low blood sugar levels. 
Alkohol lahko okrepi delovanje insulina in povzroči znižanje krvnega sladkorja.
Diabetes is a disease in which your body does not produce enough insulin to control the level of blood sugar. 
Diabetes je bolezen, pri kateri telo ne izloča dovolj insulina, da bi obvladovalo koncentracijo krvnega sladkorja.
The safety of EXUBERA alone, or in combination with subcutaneous insulin or oral agents has been evaluated in clinical studies of more than 2700 patients with type 1 or type 2 diabetes, including more than 1975 adults exposed for greater than 6 months and more than 745 adults for greater than 2 years. 
Varnost zdravila EXUBERA, bodisi samega bodisi v kombinaciji s subkutanim insulinom ali peroralnimi antidiabetiki, so ovrednotili v kliničnih študijah več kot 2700 bolnikov z diabetesom tipa 1 ali tipa 2, med drugim več kot 1975 odraslih, ki so bili izpostavljeni zdravilu več kot 6 mesecev, in več kot 745 odraslih, ki so bili zdravilu izpostavljeni več kot 2 leti.
Experience with inhaled insulin in patients 75 years of age is limited. 
Starejši bolniki Izkušnje z inhaliranim insulinom pri bolnikih, starih ≥ 75 let, so omejene.
Close your mouth and hold your breath for 5 
Zaprite usta in za 5 sekund zadržite sapo.
If your liver or kidneys do not function well speak to your doctor, who may advise that you use lower insulin doses. 
Če vaša jetra ali ledvici ne delujejo dobro, se pogovorite z zdravnikom, ki vam bo mogoče svetoval, da zmanjšajte odmerke insulina.
As with other insulins, hypoglycaemia was the most frequently observed undesirable effect in patients 
Podobno kot pri drugih insulinih, je hipoglikemija najpogostejši neželeni učinek pri bolnikih,
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. 
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.
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.
Insulin treatment can cause the body to produce antibodies to insulin (substances that bind to insulin). 
Zdravljenje z insulinom lahko povzroči, da telo začne izdelovati protitelesa (snovi, ki se vežejo na insulin) proti insulinu.
Do not open the blister containing EXUBERA. 
Ne odpirajte folije pretisnega omota, ki vsebuje zdravilo EXUBERA.
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. 
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.
The insulin inhaler should be replaced annually. 
Insulinski inhalator je treba zamenjati enkrat na leto.
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). 
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).
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. 
Ko sta komora in podnožje razstavljena (glejte “Insulinski inhalator razstavite”), primite podnožje z roko tako, da je sivi gumb obrnjen proti vam.
The blue dot on the bottom of the chamber must be on the same side as the blue button. 
Modra pika na dnu komore mora biti na
Poorly controlled, unstable, or severe asthma. 
Slabo urejena, nestabilna ali huda astma.
Therefore, EXUBERA should be used with caution in patients of low body weight. 
Zato je treba EXUBERO pri bolnikih z nizko telesno maso uporabljati previdno.
Marketing Authorisation Holder and Manufacturer The marketing authorisation holder is Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom. 
Imetnik dovoljenja za promet in izdelovalec Imetnik dovoljenja za promet z zdravilom je Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13
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. 
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
Five blister cards are in a clear plastic (PET) thermoformed tray with a desiccant and covered with a clear plastic (PET) lid. 
Pet ploščic s pretisnimi omoti je v prozornem plastičnem (PET) termooblikovanem podstavku s sušilnim sredstvom, pokrite so s pokrovčkom iz prozorne plastike (PET).
Hypoglycaemia may occur as a result of an excess of insulin relative to food intake, energy 
Hipoglikemija se lahko pojavi zaradi presežka insulina glede na zaužito hrano, porabo energije ali
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. 
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.
In each case, it may be necessary to adjust your insulin dosage to avoid too low or too high blood sugar levels. 
V vsakem primeru bo mogoče treba prilagoditi vaše odmerjanje insulina, da ne bo prišlo do prenizkih ali previsokih koncentracij krvnega sladkorja.
Mode of Action 
Način delovanja
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. 
Pred začetkom zdravljenja vam bo zdravnik s preprosto preiskavo izmeril delovanje pljuč, da se bo lahko odločil, ali je EXUBERA pravo zdravilo za vas.
-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. 
- Če ste pozabili vzeti odmerek insulina ali če ste vzeli premajhen odmerek, utegne raven vašega krvnega sladkorja preveč zrasti.
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. 
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.
In such situations, the management of your diabetes may require a lot of care and you may need to seek advice from your 
V takih primerih bo urejanje vaše sladkorne bolezni zahtevalo veliko natančnost in se boste morali za nasvet obrniti na svojega zdravnika ali medicinsko
Hypoglycaemia can generally be corrected by immediate carbohydrate intake. 
Hipoglikemijo lahko običajno popravimo s takojšnjim zaužitjem ogljikovih hidratov.
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. 
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.
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. 
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
The raised dots can be felt even when the blister is already inserted for reassurance that the 
Izbokline lahko otipate, tudi ko je pretisni omot že vstavljen, in se tako prepričate, da ste
Octreotide/lanreotide (used in special endocrine conditions) may change the need for insulin. 
Oktreotid/lanreotid (uporablja se pri posebnih boleznih žlez z notranjim izločanjem) lahko spremeni potrebe po insulinu.
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
You should change your insulin inhaler once a year from the date you first use the inhaler. 
Insulinski inhalator zamenjajte enkrat na leto, na datum, ko ste ga prvič uporabili.
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. 
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
For use only with the insulin inhaler. 
Uporabljati se sme samo z insulinskim inhalatorjem.
Unlike subcutaneous insulin preparations, the bioavailability of EXUBERA is not influenced by Body Mass Index. 
Drugače kot velja za podkožne pripravke insulina, indeks telesne mase ne vpliva na biološko uporabnost EXUBERE.
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 
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
These small treatment group differences resolved within 6 weeks upon discontinuation after 2 years of treatment (see sections 4.8 and 5.1). 
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).
Always make sure you have the correct strength and number of EXUBERA blisters available before taking your dose. 
Vedno poskrbite za to, da imate na voljo zadostno število pretisnih omotov zdravila EXUBERA pravilne jakosti, preden vzamete odmerek.
Patients developing dyspnoea while treated with EXUBERA should be examined for pulmonary or cardiac causes. 
Bolnike, ki se jim med zdravljenjem z EXUBERO pojavi dispneja, je treba pregledati glede pljučnih oz. srčnih vzrokov zanjo.