FrancophonIA/ELRC3.0 huggingface dataset:
English: Carcinogenicity studies with inhaled tobramycin do not increase the incidence of any variety of tumour.
Slovenian: V študijah kancerogenosti z inhalacijskim tobramicinom ni prišlo do povečane pojavnosti pri nobeni vrsti tumorja.
English: • Replace the mouthpiece and repeat Steps 7, 8 and 9.
Slovenian: • Ponovno namestite ustnik in ponovite korake št. 7, 8 in 9.
English: The first dose of TOBI Podhaler should be given under supervision, after using a bronchodilator if this is part of the current regimen for the patient.
Slovenian: Prvi odmerek zdravila TOBI Podhaler je treba dati pod nadzorom, in sicer po uporabi bronhodilatatorja, če ga bolnik že sicer uporablja v svoji shemi zdravljenja.
English: It is one of the most damaging bacteria for people with cystic fibrosis.
Slovenian: Za ljudi s cistično fibrozo je to ena najbolj škodljivih bakterij.
English: TOBI Podhaler inhalation powder, hard capsules consist of a white to almost white powder for inhalation filled into clear colourless hard capsules with “NVR AVCI” imprinted in blue ink on one part of the capsule and the Novartis logo imprinted in blue on the other part of the capsule.
Slovenian: TOBI Podhaler prašek za inhaliranje, trde kapsule, je bel do skoraj bel prašek za inhaliranje v prozornih, brezbarvnih trdih kapsulah z natisnjeno modro oznako "NVR AVCI" na enem delu kapsule in z modrim logotipom Novartis na drugem delu.
English: Before putting the mouthpiece in your mouth, breathe out fully, away from the inhaler.
Slovenian: Preden vstavite ustnik v usta, globoko izdihnite v smeri stran od inhalatorja.
English: The safety and efficacy of TOBI Podhaler in children aged under 6 years have not been established.
Slovenian: Pediatrični bolniki Varnost in učinkovitost zdravila TOBI Podhaler pri otrocih, starih do 6 let, nista bili dokazani.
English: When the full dose (4 capsules) has been inhaled, wipe mouthpiece with a clean dry cloth.
Slovenian: Po inhalaciji celotnega odmerka (vsebine 4 kapsul) obrišite ustnik s čisto suho krpo.
English: TOBI Podhaler is supplied in monthly packs containing 4 weekly cartons and a reserve Podhaler device in its storage case.
Slovenian: Zdravilo TOBI Podhaler je na voljo v mesečnem pakiranju, ki vsebuje 4 škatle za tedensko pakiranje in rezervni inhalator Podhaler v etuiju.
English: Safety and efficacy have not been studied in patients with forced expiratory volume in 1 second (FEV1) <25% or >75% predicted, or patients colonised with Burkholderia cepacia.
Slovenian: Varnosti in učinkovitosti zdravila niso proučevali pri bolnikih z vrednostjo forsiranega ekspiracijskega volumna v prvi sekundi (FEV1) manj kot 25 % ali več kot 75 % napovedane vrednosti, ali pri bolnikih,
English: TOBI Podhaler capsules must always be stored in the blister (capsule card), and only removed immediately before use.
Slovenian: Kapsule TOBI Podhaler je treba vedno shranjevati v pretisnem omotu (v tablici s kapsulami) in jih vzeti iz njega šele tik pred uporabo.
English: If oto- or nephrotoxicity occurs in a patient receiving TOBI Podhaler, tobramycin therapy should be discontinued until serum concentration falls below 2 µg/ml.
Slovenian: Če pri bolniku, ki jemlje zdravilo TOBI Podhaler, pride do ototoksičnosti ali nefrotoksičnosti, je treba zdravljenje s tobramicinom prekiniti, dokler se njegova koncentracija v serumu ne zniža pod 2 µg/ml.
English: If an allergic response is suspected, TOBI Podhaler should be discontinued.
Slovenian: Če obstaja sum na alergijski odziv, je treba uporabo zdravila TOBI Podhaler prekiniti.
English: • Do not wash the inhaler with water.
Slovenian: • Inhalatorja ne umivajte z vodo.
English: Based upon in vitro data and/or clinical trial experience, the organisms associated with pulmonary infections in CF may be expected to respond to TOBI Podhaler therapy as follows:
Slovenian: Na podlagi podatkov in vitro in/ali izkušenj iz kliničnih študij je mogoče pričakovati, da se bodo organizmi, ki povzročajo okužbe pljuč pri cistični fibrozi, odzivali na zdravljenje z zdravilom TOBI
English: Please also refer to nephrotoxicity information in section 4.4.
Slovenian: Glejte tudi podatke o toksičnosti za ledvice v poglavju 4.4.
English: 3 years Discard the Podhaler device and its case 1 week after first use.
Slovenian: 3 leta Inhalator Podhaler skupaj z etuijem zavrzite 1 teden po prvi uporabi.
English: • Unusual difficulty in breathing with wheezing or coughing and chest tightness (common).
Slovenian: • neobičajno oteženo dihanje s piskanjem ali kašljem in z občutkom stiskanja v prsih (pogosti).
English: One capsule contains 28 mg tobramycin.
Slovenian: Ena kapsula vsebuje 28 mg tobramicina.
English: The clinical significance of changes in MICs of tobramycin for P. aeruginosa has not been clearly established in the treatment of cystic fibrosis patients.
Slovenian: Klinični pomen spreminjanja MIK tobramicina za bakterije P. aeruginosa pri zdravljenju bolnikov s cistično fibrozo ni povsem dognan.
English: Over half of the patients in both the TOBI Podhaler and TOBI nebuliser solution treatment groups received new (additional) anti-pseudomonal antibiotics (64.9% and 54.5% respectively, the difference consisting mainly of oral ciprofloxacin use).
Slovenian: Tako v skupini z zdravilom TOBI Podhaler kot v skupini z raztopino za nebulator TOBI je več kot polovica bolnikov prejemala nove (dodatne) antibiotike z delovanjem proti bakteriji P. aeruginosa (64,9 % oziroma 54,5 % bolnikov, do razlike je prišlo predvsem zaradi uporabe peroralnega ciprofloksacina).
English: There is a theoretical risk that patients being treated with TOBI Podhaler may develop P. aeruginosa isolates resistant to intravenous tobramycin over time (see section 5.1).
Slovenian: Pri bolnikih, ki jemljejo zdravilo TOBI Podhaler, obstaja teoretično tveganje, da se pri njih sčasoma razvijejo izolati bakterije P. aeruginosa, ki so rezistentni na intravenski tobramicin (glejte poglavje 5.1).
English: Then peel back the foil by rolling it back from the capsule card to reveal one capsule at a time, see Figures (c) and (d).
Slovenian: Nato potegnite zaščitno folijo s tablice s kapsulami, tako da folijo zvijate nazaj in odkrijete vsakokrat samo eno kapsulo, glejte sliki (c) in (d).
English: Adequate data do not exist for the use of TOBI Podhaler in patients after organ transplantation.
Slovenian: O uporabi zdravila TOBI Podhaler pri bolnikih po presaditvi organa ni na voljo zadostnih podatkov.
English: Furthermore, an improvement of 6% in percent predicted FEV1 was obtained in about 30% versus 36% of the adult patients in the TOBI Podhaler and TOBI nebuliser solution group respectively.
Slovenian: Poleg tega je do povečanja odstotka napovedane vrednosti FEV1 za 6 % prišlo pri približno 30 % odraslih bolnikov v skupini z zdravilom TOBI Podhaler v primerjavi s 36 % odraslih bolnikov v skupini z raztopino za nebulator TOBI.
English: Each Podhaler device and its case are used for seven days and then discarded and replaced.
Slovenian: En inhalator Podhaler z etuijem je namenjen sedemdnevni uporabi, nato pa ga je treba zavreči in vzeti novega.
English: The extent of systemic exposure (AUC) was also similar for the 112 mg TOBI Podhaler dose and the 300 mg tobramycin nebuliser solution dose.
Slovenian: Tudi obseg sistemske izpostavljenosti (AUC) je bil podoben pri uporabi odmerka 112 mg zdravila TOBI Podhaler in pri uporabi odmerka 300 mg raztopine tobramicina za nebulator.
English: If you experience any of these, tell your doctor straight away.
Slovenian: Če pride do katerega od teh simptomov pri vas, takoj obvestite zdravnika.
English: Inhale the capsule - 2nd breath:
Slovenian: Inhalirajte vsebino kapsule - drugi vdih:
English: The recommended dose is 112 mg tobramycin (4 x 28 mg capsules), administered twice daily for 28 days.
Slovenian: Priporočeni odmerek je 112 mg tobramicina (štiri 28-miligramske kapsule), ki ga bolnik jemlje 28 dni dvakrat dnevno.
English: If you are taking tobramycin or another aminoglycoside antibiotic by injection, it can sometimes cause hearing loss, dizziness and kidney damage.
Slovenian: Če uporabljate tobramicin ali druge aminoglikozidne antibiotike v obliki injekcij, lahko v nekaterih primerih pride do poslabšanja sluha, omotičnosti in okvare ledvic.
English: Please check the order of medications with your doctor.
Slovenian: Glede vrstnega reda uporabe zdravil se dogovorite z zdravnikom.
English: Patients receiving concomitant parenteral aminoglycoside therapy (or any medication affecting renal excretion, such as diuretics) should be monitored as clinically appropriate taking into account the risk of cumulative toxicity.
Slovenian: Pri bolnikih, ki sočasno parenteralno prejemajo druga aminoglikozidna zdravila (ali katero od drugih zdravil, ki vplivajo na izločanje preko ledvic, na primer diuretike), je treba upoštevati možnost kumulativne toksičnosti.
English: TOBI Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis.
Slovenian: Zdravilo TOBI Podhaler je indicirano za supresivno zdravljenje kronične okužbe pljuč z bakterijo Pseudomonas aeruginosa pri odraslih in otrocih, starih 6 let ali več, ki imajo cistično fibrozo.
English: The powder in the capsules is for you to inhale.
Slovenian: Prašek v kapsulah je namenjen za inhaliranje.
English: Patients who were randomised to the placebo treatment group received placebo during the first treatment cycle and TOBI Podhaler in the subsequent two cycles.
Slovenian: Bolniki, ki so bili randomizirani v skupino s placebom, so v prvem ciklusu zdravljenja prejemali placebo, v drugih dveh ciklusih pa zdravilo TOBI Podhaler.
English: Inhalation powder, hard capsules 56 capsules + 1 inhaler
Slovenian: prašek za inhaliranje, trde kapsule 56 kapsul + 1 inhalator
English: TOBI Podhaler is taken in alternating cycles of 28 days on treatment followed by 28 days off treatment.
Slovenian: Zdravilo TOBI Podhaler je treba jemati v izmeničnih ciklusih, 28-im dnem zdravljenja sledi 28-dnevno obdobje brez zdravljenja.
English: Treatment with TOBI Podhaler for 28 days resulted in a statistically significant reduction in P. aeruginosa sputum density (mean difference with placebo about 2.70 log10 in colony forming units/CFUs).
Slovenian: Zdravljenje z zdravilom TOBI Podhaler 28 dni je statistično značilno zmanjšalo gostoto bakterij P. aeruginosa v izpljunku (razlika v primerjavi s placebom približno 2,70 log10 v kolonijskih enotah (colony forming units - CFUs)).
English: Do not overtighten.
Slovenian: Pazite, da ga ne zategnete preveč.
English: This should be taken into account before prescribing TOBI Podhaler, considering the inhalation powder TOBI Podhaler was associated with a higher rate of cough (see above).
Slovenian: Navedeno je treba upoštevati pri predpisovanju zdravila TOBI Podhaler, glede na to, da je bil prašek za inhaliranje TOBI Podhaler povezan s pogostejšim kašljem (glejte zgoraj).
English: In a 6-month (3 treatment cycles) study of TOBI Podhaler versus tobramycin nebuliser solution, which included a majority of tobramycin-experienced adult patients with chronic pulmonary P. aeruginosa infection, the suppression of sputum P. aeruginosa density was similar across age groups in both arms; however the increase from baseline FEV1 was larger in younger age groups (6 - <20) than in the adult subgroup (20 years and older) in both arms.
Slovenian: V 6-mesečni študiji (s 3 ciklusi zdravljenja) z zdravilom TOBI Podhaler v primerjavi z raztopino tobramicina za nebulator, v katero so bili vključeni večinoma odrasli bolniki, ki so imeli kronično okužbo z bakterijo P. aeruginosa in so že prej prejemali tobramicin, je bilo zmanjšanje gostote bakterij P. aeruginosa v izpljunku v obeh krakih podobno v vseh starostnih skupinah, pri tem pa je bilo zvečanje vrednosti FEV1 od izhodišča v obeh krakih večje pri mlajših starostnih skupinah (6<20 let) v primerjavi s podskupino odraslih (starih 20 let ali več).
English: Tear along the perforations of the capsule card lengthwise then widthwise, as indicated in pictures (1) and (2).
Slovenian: Trgajte po perforaciji tablice s kapsulami najprej po dolžini in nato po širini, kot prikazujeta sliki 1 in 2.
English: Set the mouthpiece aside on a clean, dry surface.
Slovenian: Ustnik odložite na čisto in suho površino.
English: The proportions of patients requiring hospitalisation for respiratory events were 24.4% with TOBI Podhaler and 22.0% with TOBI nebuliser solution.
Slovenian: V skupini z zdravilom TOBI Podhaler je zaradi respiratornih dogodkov potrebovalo hospitalizacijo 24,4 % bolnikov, v skupini z raztopino za nebulator TOBI pa 22,0 % bolnikov.
English: Contents of the pack and other information What TOBI Podhaler contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo TOBI Podhaler
English: What TOBI Podhaler is and what it is used for What you need to know before you take TOBI Podhaler How to take TOBI Podhaler Possible side effects
Slovenian: Kaj je zdravilo TOBI Podhaler in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo TOBI Podhaler Kako jemati zdravilo TOBI Podhaler
English: • It is best to leave close to 12 hours between doses, but this must be at least 6 hours
Slovenian: • časovni razmik med odmerkoma naj bo čim bližje 12 uram, vsekakor pa naj bo med odmerkoma najmanj 6 ur.
English: 1 reserve inhaler inside.
Slovenian: Pakiranje vsebuje 1 rezervni inhalator.
English: When patients in the placebo treatment group were switched from placebo to TOBI Podhaler at the start of the second treatment cycle, they experienced a similar improvement from baseline in percent predicted FEV1.
Slovenian: Pri bolnikih v skupini s placebom je po prehodu s placeba na zdravilo TOBI Podhaler na začetku drugega ciklusa zdravljenja prišlo do podobnega izboljšanja odstotka napovedane FEV1 od izhodišča.
English: • Never place a TOBI Podhaler capsule directly into the mouthpiece of the device.
Slovenian: • Kapsule zdravila TOBI Podhaler nikoli ne vstavite neposredno v ustnik inhalatorja.
English: A population pharmacokinetic analysis for TOBI Podhaler in cystic fibrosis patients estimated the apparent volume of distribution of tobramycin in the central compartment to be 84.1 litres for a typical CF patient.
Slovenian: Na podlagi analize populacijske farmakokinetike zdravila TOBI Podhaler pri bolnikih s cistično fibrozo je pri tipičnem bolniku s cistično fibrozo ocenjeni navidezni volumen porazdelitve tobramicina v centralnem kompartmentu 84,1 litra.
English: A numerically lower response in patients aged ≥20 years was observed: the change from baseline FEV1 observed in the patients aged ≥20 years was smaller (0.3% with TOBI Podhaler and 0.9% with TOBI nebuliser solution).
Slovenian: starih 20 let ali več, so opažali številčno slabši odziv: pri bolnikih, starih 20 let ali več, je bila sprememba FEV1 od izhodišča manjša (0,3 % pri uporabi zdravila TOBI Podhaler in 0,9 % pri uporabi raztopine za nebulator TOBI).
English: When you inhale TOBI Podhaler, the antibiotic can enter directly into your lungs to fight against the bacteria causing the infection and to improve your breathing.
Slovenian: Podhaler, pride antibiotik neposredno v pljuča, deluje proti bakterijam, ki povzročajo okužbo, in izboljša dihanje.
English: At the end of a 4-week dosing cycle of TOBI Podhaler (112 mg twice daily), maximum serum concentration of tobramycin 1 hour after dosing was 1.99 ± 0.59 µg/ml.
Slovenian: Po koncu 4-tedenskega ciklusa odmerjanja zdravila TOBI Podhaler (112 mg dvakrat na dan) je bila najvišja koncentracija tobramicina v serumu 1 uro po odmerjanju 1,99 ± 0,59 µg/ml.
English: Inhaling medicines can also cause cough and this can happen with TOBI Podhaler.
Slovenian: Inhaliranje zdravil lahko povzroči tudi kašelj, do česar lahko pride tudi pri uporabi zdravila TOBI Podhaler.
English: The TOBI Podhaler Phase III clinical development programme consisted of two studies and 612 treated patients with a clinical diagnosis of CF, confirmed by quantitative pilocarpine iontophoresis sweat chloride test or well-characterised disease causing mutations in each cystic fibrosis transmembrane regulator (CFTR) gene, or abnormal nasal transepithelial potential difference characteristic of CF.
Slovenian: Klinične izkušnje Faza III kliničnega razvoja zdravila TOBI Podhaler je obsegala dve študiji in 612 zdravljenih bolnikov s klinično diagnozo cistične fibroze, potrjeno s testom vsebnosti kloridov v znoju s kvantitativno pilokarpinsko iontoforezo ali z dobro opredeljeno boleznijo, ki povzroča mutacije v obeh CFTR genih
English: • When you start a new weekly pack of capsules, use the new inhaler that is supplied in the pack.
Slovenian: • Ko odprete novo tedensko pakiranje kapsul, začnite uporabljati tudi nov inhalator, ki je priložen pakiranju.
English: • Pierce the capsule by pressing firmly the blue button with your thumb as far as it will go, then release the button.
Slovenian: • Kapsulo predrete tako, da s palcem močno pritisnete na moder gumb kolikor gre in nato gumb spustite.
English: If the capsule is punctured but still contains some powder, place it back into the inhaler and take another two inhalations from the capsule.
Slovenian: Če je kapsula predrta, vendar vsebuje še nekaj praška, jo vstavite nazaj v inhalator in z dodatnima dvema vdihoma vdihnite vsebino iz kapsule.
English: • Amphotericin B, cefalotin, polymyxins (used to treat microbial infections), ciclosporin, tacrolimus (used to reduce the activity of immune system).
Slovenian: • amfotericin B, cefalotin, polimiksini (za zdravljenje okužb z mikrobi), ciklosporin, takrolimus
English: INSTRUCTIONS FOR USE OF THE PODHALER DEVICE
Slovenian: NAVODILA ZA UPORABO INHALATORJA PODHALER
English: • Set the mouthpiece aside on a clean, dry surface.
Slovenian: • Ustnik odložite na čisto in suho površino.
English: To puncture capsule, hold the inhaler with the mouthpiece down, press the button firmly with your thumb as far as it will go, then release the button.
Slovenian: Kapsulo predrete tako, da držite inhalator obrnjen z ustnikom navzdol, s palcem pa kolikor gre močno pritisnete na gumb, in gumb nato spustite.
English: Tobramycin showed no genotoxic potential in a battery of genotoxicity tests.
Slovenian: Tobramicin v sklopu genotoksičnih testov ni kazal genotoksičnega potenciala.
English: In the absence of conventional susceptibility breakpoints for the inhaled route of administration, caution must be exercised in defining organisms as susceptible or insusceptible to inhaled tobramycin.
Slovenian: Ker pri vnosu zdravila z inhalacijo ni na voljo običajnih mejnih vrednosti za občutljivost bakterij, je potrebna previdnost pri opredelitvi, kateri organizmi so občutljivi oziroma neobčutljivi na inhalacijski tobramicin.
English: If TOBI Podhaler is swallowed, don't worry but tell your doctor as soon as possible.
Slovenian: Če zdravilo TOBI Podhaler pogoltnete, naj vas ne skrbi, a kljub temu čimprej obvestite zdravnika.
English: • Chest discomfort, chest pain from muscles or skeletal origins
Slovenian: • piskanje pri dihanju, vlažni hropci • neprijeten občutek v prsih, bolečine v prsih, ki so mišičnega ali skeletnega izvora
English: • Never blow into the mouthpiece of the device.
Slovenian: • Nikoli ne pihajte v ustnik inhalatorja.
English: Hold the foil close to where you are rolling back.
Slovenian: Ko vlečete zaščitno folijo, jo držite blizu mesta, kjer jo zvijate nazaj.
English: Reinspect capsule.
Slovenian: Nato kapsulo ponovno preglejte.
English: Discard the empty capsule.
Slovenian: Zavrzite prazno kapsulo.
English: If you experience any of these, stop taking TOBI Podhaler and tell your doctor straight away.
Slovenian: Če pride do katerega od teh simptomov pri vas, prenehajte jemati zdravilo TOBI Podhaler in takoj obvestite zdravnika.
English: TOBI Podhaler capsules must not be swallowed.
Slovenian: Kapsul zdravila TOBI Podhaler se ne sme pogoltniti.
English: While the volume was shown to vary with body mass index (BMI) and lung function (as FEV1% predicted), model-based simulations showed that peak (Cmax) and trough (Ctrough) concentrations were not impacted markedly with changes in BMI or lung function.
Slovenian: (ITM) in pljučne funkcije (kot jo izraža odstotek napovedane vrednosti FEV1), je simulacija z modelom pokazala, da spremembe ITM in pljučne funkcije ne vplivajo bistveno na najvišjo (Cmax) in najnižjo (Cnajnižja) koncentracijo.
English: Unscrew mouthpiece and remove the capsule from the chamber.
Slovenian: Odvijte ustnik in vzemite kapsulo iz ležišča.
English: In a randomised, double-blind, placebo-controlled, multicentre study, TOBI Podhaler 112 mg (4 x 28 mg capsules) was administered twice daily, for three cycles of 28 days on-treatment and 28 days off-treatment (a total treatment period of 24 weeks).
Slovenian: V randomizirani, dvojno slepi, s placebom kontrolirani, multicentrični študiji so bolniki prejemali zdravilo TOBI Podhaler v odmerku 112 mg (štiri 28-miligramske kapsule) dvakrat na dan v treh 28-dnevnih ciklusih, od katerih je vsakemu sledilo 28-dnevno obdobje brez zdravljenja (skupno je obdobje zdravljenja trajalo 24 tednov).
English: There are insufficient data in this population to support a recommendation for or against dose adjustment.
Slovenian: Pri tej skupini bolnikov ni dovolj podatkov o uporabi zdravila, da bi lahko priporočali ali odsvetovali morebitno prilagajanje odmerkov.
English: The unique characteristics of chronic P. aeruginosa infections in CF patients, such as anaerobic conditions and high frequency of genetic mutations, may also be important factors for reduced susceptibility of P. aeruginosa in CF patients.
Slovenian: Pri bolnikih s cistično fibrozo lahko predstavljajo pomemben dejavnik za zmanjšano občutljivost bakterij P. aeruginosa tudi posebne značilnosti kronične okužbe z bakterijo P. aeruginosa, kot so anaerobni pogoji in velika pogostnost genskih mutacij.
English: • Remove the capsule from the card.
Slovenian: • Kapsulo vzemite iz tablice.
English: Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected neuromuscular disorders such as myasthenia gravis or Parkinson's disease.
Slovenian: Pri predpisovanju zdravila TOBI Podhaler bolnikom z ugotovljeno živčno-mišično boleznijo, kot sta miastenija gravis ali Parkinsonova bolezen, ali s sumom na tako bolezen, je potrebna previdnost.
English: Subcutaneous administration of tobramycin did not affect mating behaviour or cause impairment of fertility in male or female rats.
Slovenian: Pri podganah subkutana aplikacija tobramicina ni vplivala na paritveno vedenje in ni zmanjševala plodnosti niti pri samcih niti pri samicah.
English: A majority of the patients were tobramycin-experienced adults with chronic pulmonary P. aeruginosa infection.
Slovenian: Večina bolnikov je bila odraslih s kronično okužbo pljuč z bakterijo P. aeruginosa in so že prej prejemali tobramicin.
English: Development of resistance during inhaled tobramycin therapy could limit treatment options during acute exacerbations; this should be monitored.
Slovenian: Razvoj rezistence v času zdravljenja z inhalacijskim tobramicinom lahko zmanjša izbor zdravil, ki bi bila sicer primerna v primerih akutnega poslabšanja.
English: Tobramycin is primarily excreted unchanged in the urine and renal function is expected to affect the exposure to tobramycin.
Slovenian: Tobramicin se pretežno izloča z urinom v nespremenjeni obliki, zato je mogoče pričakovati, da delovanje ledvic vpliva na izpostavljenost tobramicinu.
English: If you are taking several different inhaled treatments and following other therapies for cystic fibrosis, you should take TOBI Podhaler after all of these are done.
Slovenian: Če uporabljate več različnih inhalacijskih zdravil in načinov zdravljenja cistične fibroze, vzemite zdravilo TOBI Podhaler kot zadnje po uporabi drugih zdravil.
English: If the capsule appears to be unpunctured, place it back into the inhaler, press the button firmly as far as it goes and take another two inhalations from the capsule.
Slovenian: Če kapsula ni videti predrta, jo vstavite nazaj v inhalator, kolikor gre močno pritisnite na gumb, in z dodatnima dvema vdihoma vdihnite vsebino iz kapsule.