natgillin/translations-raw huggingface dataset:
Established susceptibility breakpoints for parenteral administration of tobramycin are inappropriate in the aerosolised administration of the medicinal product. 
Ustanovljene granice osjetljivosti za parenteralnu primjenu tobramicina ne odgovaraju onima kod primjene lijeka aerosolom.
Unscrew mouthpiece and remove the capsule from the chamber. 
Odvijte nastavak za usta i izvadite kapsulu iz komore.
In the placebo-controlled study with TOBI Podhaler, the adverse reactions for which reported frequency was higher with TOBI Podhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia. 
U placebom kontroliranom ispitivanju s TOBI Podhalerom, nuspojave za koje je zabilježena učestalost bila viša s TOBI Podhalerom nego s placebom bile su faringolaringealna bol, disgeuzija i disfonija.
• Fever 
• Vrućicu
If this applies to you, tell your doctor without taking TOBI Podhaler. 
Ako se to odnosi na Vas, obavijestite svog liječnika i nemojte uzimati TOBI Podhaler.
If oto- or nephrotoxicity occurs in a patient receiving TOBI Podhaler, tobramycin therapy should be discontinued until serum concentration falls below 2 µg/ml. 
Podhaler dođe do ototoksičnosti ili nefrotoksičnosti, potrebno je prekinuti terapiju tobramicinom dok koncentracija u serumu ne padne ispod 2 µg/ml.
• 1 inhaler (the Podhaler device) and its storage case. 
• 1 inhalator (uređaj Podhaler) sa spremnikom za čuvanje.
Inhale the capsule - 1st breath: 
Inhalirajte kapsulu - prvi udisaj:
Just before use, remove the Podhaler device from its case. 
Neposredno prije primjene izvadite uređaj Podhaler iz spremnika.
• Replace the mouthpiece and repeat Steps 7, 8 and 9. 
• Vratite nastavak za usta i ponovite korake 7, 8 i 9.
• Just before use, remove the inhaler from its case by holding the base and twisting off the top of the case in an anti-clockwise direction. 
• Netom prije uporabe izvadite inhalator iz spremnika tako da držite dno i odvrnete vrh spremnika u smjeru suprotnom od kazaljke na satu.
In the active controlled studies, all patients were aged >6years old (range 6-66 years) with an FEV1 % predicted at screening of between 24% and 76%. 
U aktivno kontroliranim ispitivanjima svi su bolesnici imali >6 godina (raspon 6-66 godina)
If there is evidence of therapy-induced bronchospasm, the physician should carefully evaluate whether the benefits of continued use of TOBI Podhaler outweigh the risks to the patient. 
Ako se utvrdi postojanje bronhospazma izazvanog terapijom, liječnik mora pažljivo ocijeniti premašuju li koristi od korištenja TOBI Podhalera rizike za bolesnika.
The maximum tolerated daily dose of TOBI Podhaler has not been established. 
Najveća podnošljiva dnevna doza TOBI
How to store TOBI Podhaler Contents of the pack and other information Instructions for use with the Podhaler device (overleaf) 
Sadržaj pakiranja i druge informacije Upute za uporabu s uređajem Podhaler (na drugoj strani)
Inhalation powder, hard capsules Multipack: 448 capsules (2 packs of 224 + 5 inhalers) 
Prašak inhalata, tvrde kapsule Višestruko pakiranje: 448 kapsula (2 pakiranja od 224 + 5 inhalatora)
If you inhale too much TOBI Podhaler, tell your doctor as soon as possible. 
Ako inhalirate previše TOBI Podhalera, što prije se obratite svom liječniku.
Mylan Finland Oy Puh/Tel: +358 20 720 9555 
Puh/Tel: +358 20 720 9555
• Always keep the TOBI Podhaler capsules and device in a dry place. 
• Uvijek čuvajte TOBI Podhaler kapsule i uređaj na suhom mjestu.
Contains 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), calcium chloride and sulphuric acid (for pH adjustment). 
Sadrži 1,2-distearoil-sn-glicero-3-fosfokolin (DSPC), kalcijev klorid i sulfatnu kiselinu (za podešavanje pH).
Each weekly carton contains 7 blisters (capsule cards) of 8 capsules each, and a Podhaler device in its storage case. 
Svaka tjedna kutija sadrži 7 blistera (kartica s kapsulama) od po 8 kapsula, te uređaj Podhaler u svojem spremniku za čuvanje.
If you forget to take TOBI Podhaler 
Ako ste zaboravili uzeti TOBI Podhaler
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. 
Ako uzimate nekoliko različitih inhalacijskih lijekova kao i drugu terapiju za cističnu fibrozu, TOBI
TOBI Podhaler capsules must always be stored in the blister to protect from moisture and only removed immediately before use. 
TOBI Podhaler kapsule uvijek se moraju čuvati u blisteru radi zaštite od vlage te izvaditi tek neposredno prije primjene.
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. 
Podhalera mora dati pod nadzorom, nakon uporabe bronhodilatatora ako je to dio terapije koju bolesnik trenutačno prima.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MONTHLY INTERMEDIATE CARTON OF MULTIPACK COMPRISING 2 MONTHLY PACKS, EACH CONTAINING 4 WEEKLY PACKS) (WITHOUT BLUE BOX) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU MJESEČNA UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA KOJE SE SASTOJI OD 2 MJESEČNA PAKIRANJA, OD KOJIH SVAKO SADRŽI 4 TJEDNA PAKIRANJA) (BEZ PLAVOG OKVIRA)
Store the Podhaler device in its tightly closed case when not in use. 
Čuvajte uređaj Podhaler u njegovom čvrsto zatvorenom spremniku kada se ne koristi.
• Amphotericin B, cefalotin, polymyxins (used to treat microbial infections), ciclosporin, tacrolimus (used to reduce the activity of immune system). 
• Amfotericin B, cefalotin, polimiksini (koji se koriste za liječenje mikrobnih infekcija),
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. 
antibiotik može ući izravno u Vaša pluća kako bi se borio protiv bakterija koje uzrokuju infekciju te
Nephrotoxicity was not observed during TOBI Podhaler clinical studies. 
Nefrotoksičnost nije uočena tijekom kliničkih ispitivanja TOBI Podhalera.
In the event of accidental oral ingestion of TOBI Podhaler capsules, toxicity is unlikely as tobramycin is poorly absorbed from an intact gastrointestinal tract. 
Podhaler kapsula, mala je vjerojatnost toksičnosti budući da se tobramicin slabo apsorbira iz intaktnog gastrointestinalnog trakta.
Place inhaler back in storage case and close tightly. 
Vratite inhalator natrag u spremnik i čvrsto ga zatvorite.
What TOBI Podhaler looks like and contents of the pack 
Podhaler izgleda i sadržaj pakiranja
Inhalation powder, hard capsules Multipack: 224 capsules (4 packs of 56 + 1 inhaler) + reserve inhaler 
Prašak inhalata, tvrde kapsule Višestruko pakiranje: 224 kapsule (4 pakiranja od 56 + 1 inhalator) + rezervni inhalator
After inhalation of a 112 mg single dose (4 x 28 mg capsules) of TOBI Podhaler in cystic fibrosis patients, sputum Cmax of tobramycin was 1047 ± 1080 µg/g (mean ± SD). 
Nakon inhalacije jednokratne doze od 112 mg (4 x 28 mg kapsule) TOBI Podhalera u bolesnika s cističnom fibrozom, Cmax tobramicina u sputumu bio je 1047 ± 1080 µg/g (srednja vrijednost ± SD).
• Pierce the capsule by pressing firmly the blue button with your thumb as far as it will go, then release the button. 
• Probušite kapsulu tako što ćete palcem čvrsto do kraja pritisnuti plavu tipku, a zatim je otpustite.
In comparison, after inhalation of a single dose of tobramycin 300 mg/5 ml nebuliser solution (TOBI), Cmax was 1.04 ± 0.58 µg/ml and median Tmax was one hour. 
Za usporedbu, nakon inhalacije jednokratne doze tobramicin 300 mg/5 ml otopine za nebulizator (TOBI), Cmax je bio 1,04 ± 0,58 µg/ml, a medijan Tmax bio je jedan sat.
• Replace the mouthpiece and repeat steps 8,9 and 10. 
• Vratite nastavak za usta i ponovite korake 8, 9 i 10.
• Hold the body of the inhaler and unscrew the mouthpiece in an anti-clockwise direction. 
• Držite tijelo inhalatora i odvijte nastavak za usta u smjeru suprotnom od smjera kazaljki na satu.
Four patients in the TOBI Podhaler treatment group experienced significant decreases in hearing which were transient in three patients and persistent in one case. 
Podhaler doživjela značajan gubitak sluha koji je bio prolazan u tri bolesnika, a trajan u jednog bolesnika.
Sulfuric acid (for pH adjustment) 
(za podešavanje pH).
Other medicines and TOBI Podhaler 
Drugi lijekovi i TOBI
For use only with the inhaler provided in the pack. 
Za uporabu samo uz inhalator priložen u pakiranju.
Children below the age of 13 years may be more likely to cough when treated with TOBI Podhaler compared with older subjects. 
Veća je vjerojatnost da će djeca mlađa od 13 godina kašljati uslijed terapije TOBI
PHARMACEUTICAL PARTICULARS 6.1 List of excipients 
FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari Sadržaj kapsule
Adverse reactions specifically associated with overdose of TOBI Podhaler have not been identified. 
Nuspojave specifično povezane s predoziranjem TOBI Podhalerom nisu utvrđene.
How long to take TOBI Podhaler 
Koliko dugo uzimati TOBI Podhaler
In the placebo controlled study, patients were aged 6 - ≤22 years with an FEV1 at screening of between 25% and 84% of predicted normal values for their age, sex and height based upon Knudson criteria. 
25% i 84% od predviđenih normalnih vrijednosti za svoju dob, spol i visinu na temelju Knudsonovih kriterija.
224 (4 x 56) capsules and 5 inhalers (monthly multipack) 448 (8 x 56) capsules and 10 inhalers (2 x monthly multipack wrapped in foil) Not all pack sizes may be marketed. 
224 (4 x 56) kapsula i 5 inhalatora (mjesečno višestruko pakiranje) 448 (8 x 56) kapsula i 10 inhalatora (2 x mjesečno višestruko pakiranje zamotano u foliju)
Separate the morning and evening doses from the capsule card. Peel back the foil from the capsule card to reveal one TOBI Podhaler capsule and remove it from the card. 
Skinite foliju s kartice s kapsulama kako biste otkrili jednu TOBI Podhaler kapsulu i izvadili je iz kartice.
If any of these apply to you, tell your doctor before taking TOBI Podhaler. 
Ako se bilo što od navedenoga odnosi na Vas, obavijestite svog liječnika prije nego uzmete TOBI Podhaler.
After inhalation of a 112 mg single dose (4 x 28 mg capsules) of TOBI Podhaler in cystic fibrosis patients, the maximum serum concentration (Cmax) of tobramycin was 1.02 ± 0.53 μg/ml (mean ± SD) and the median time to reach the peak concentration (Tmax) was one hour. 
Nakon inhalacije jednokratne doze od 112 mg (4 x 28 mg kapsule) TOBI Podhalera u bolesnika s cističnom fibrozom, maksimalna koncentracija tobramicina u serumu (Cmax) bila je 1,02 ± 0,53 μg/ml (srednja vrijednost ± SD) a medijan vremena do postizanja vršne koncentracije (Tmax) bio je jedan sat.
Cough was reported with use of TOBI Podhaler in clinical studies. 
Kašalj Kašalj je zabilježen uz primjenu TOBI Podhalera u kliničkim ispitivanjima.
Unscrew mouthpiece (1) and remove the capsule from the chamber (2). 
Odvijte nastavak za usta (1) i izvadite kapsulu iz komore
Keep it dry and store it in its case. 
Čuvajte ga na suhom i pohranite u spremnik.
• Only use the inhaler contained in this pack. 
• Koristite samo inhalator priložen u ovom pakiranju.
The most commonly reported adverse reactions in the main safety, active-controlled clinical study with TOBI Podhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis. 
TOBI Podhalera u usporedbi s tobramicin otopinom za nebulizator u bolesnika s cističnom fibrozom i infekcijom s P. aeruginosa bile su kašalj, produktivan kašalj, pireksija, dispneja, orofaringealna bol, disfonija i hemoptiza.
Mylan Italia SRL Tel: +39 0261246921 
Tel: +39 0261246921
Please discard inhaler and its case after 1 week of use. 
Baciti inhalator i njegov spremnik nakon 1 tjedna uporabe.
Aphonia 
Afonija
Always take TOBI Podhaler exactly as your doctor has told you. 
Podhaler točno onako kako Vam je rekao liječnik.
• The other ingredients are DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine), calcium chloride, sulfuric acid (for pH adjustment). 
• Drugi sastojci su DSPC (1,2-distearoil-sn-glicero-3-fosfokolin), kalcijev klorid, sulfatna kiselina
Clinical studies with inhaled tobramycin solution (TOBI) have shown a small increase in tobramycin, amikacin and gentamicin Minimum Inhibitory Concentrations for P. aeruginosa isolates tested. 
pokazala su malo povećanje u minimalnim inhibitornim koncentracijama tobramicina, amikacina i gentamicina za testirane izolate P. aeruginosa.
This necessitates sputum concentrations of tobramycin after inhalation to be about ten-fold above the minimum inhibitory concentration (MIC) or higher for P. aeruginosa suppression. 
Zbog toga za supresiju P. aeruginosa koncentracije tobramicina u sputumu nakon inhalacije moraju biti oko deset puta iznad minimalne inhibitorne koncentracije (MIK) ili više.
• Chest discomfort, chest pain from muscles or skeletal origins 
• Nelagodu u prsnom košu, bol mišića ili kostiju prsnog koša
Other medicinal products that have been reported to increase the potential toxicity of parenterally administered aminoglycosides include: - amphotericin B, cefalotin, ciclosporin, tacrolimus, polymyxins (risk of increased nephrotoxicity); - platinum compounds (risk of increased nephrotoxicity and ototoxicity); - anticholinesterases, botulinum toxin (neuromuscular effects). 
- amfotericin B, cefalotin, ciklosporin, takrolimus, polimiksini (rizik od povećane nefrotoksičnosti); - spojeve koji sadržavaju platinu (rizik od povećane nefrotoksičnosti i ototoksičnosti);
BGP Products SIA Tālr: +371 676 055 80 
Tālr: +371 676 055 80
Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. 
Unutar svake skupine učestalosti, nuspojave su prikazane od težih prema blažima.
How to inhale your medicine with the Podhaler device • Only use Podhaler device contained in this pack. 
Kako inhalirati Vaš lijek pomoću uređaja Podhaler
Nephrotoxicity has been reported with the use of parenteral aminoglycosides. 
Nefrotoksičnost je zabilježena kod primjene parenteralnih aminoglikozida.
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). 
Podhaler 112 mg (4 x 28 mg kapsule) primjenjivao se dvaput na dan, tijekom tri ciklusa od po 28 dana uzimanja terapije te 28 dana neuzimanja terapije (ukupno razdoblje liječenja od 24 tjedna).
• Blocked nose 
• Začepljen nos
Musculoskeletal chest pain 
Mišićno-koštana bol u prsnom košu
• Store the Podhaler device in its tightly closed case when not in use. 
• Čuvajte uređaj Podhaler u čvrsto zatvorenom spremniku kada se ne koristi.
• Discoloration of the substance you cough up (sputum) 
• Promjena boje tvari koju iskašljavate (ispljuvka)
See also “Monitoring of serum tobramycin concentrations” above. 
Vidjeti također „Praćenje koncentracije tobramicina u serumu“ gore.
• Peel back the foil from the capsule card to reveal one capsule only. 
• Skinite foliju s kartice s kapsulama tako da se vidi samo jedna kapsula.
The apparent terminal half-life of tobramycin in serum after inhalation of a 112 mg single dose of TOBI Podhaler was approximately 3 hours in cystic fibrosis patients and consistent with the half-life of tobramycin after inhalation of tobramycin 300 mg/5 ml nebuliser solution (TOBI). 
Podhalera bio je otprilike 3 sata u bolesnika s cističnom fibrozom i u skladu s poluvijekom tobramicina nakon inhalacije tobramicin 300 mg/5 ml otopine za nebulizator (TOBI).
In clinical studies, some patients on TOBI Podhaler therapy showed an increase in aminoglycoside minimum inhibitory concentrations (MIC) for P. aeruginosa isolates tested. 
Podhaler pokazali su povećanje minimalnih inhibitornih koncentracija (MIK) aminoglikozida za testirane izolate P. aeruginosa.
TOBI Podhaler 28 mg inhalation powder, hard capsules 
TOBI Podhaler 28 mg prašak inhalata, tvrde kapsule
Bronchospasm can occur with inhalation of medicinal products and has been reported with TOBI Podhaler in clinical studies. 
Bronhospazam koji može nastupiti nakon inhalacije lijekova zabilježen je u kliničkim ispitivanjima i uz primjenu TOBI Podhalera.
• Screw the mouthpiece on firmly until it stops. 
• Čvrsto navijte nastavak za usta dok se ne zaustavi.
Replace the mouthpiece and screw it on firmly until it stops. 
Vratite nastavak za usta i čvrsto ga navijte dok se ne zaustavi.
• Nosebleed 
• Grlobolju
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). 
Zatim skinite foliju povlačeći je s kartice s kapsulama tako da otkrijete jednu po jednu kapsulu, vidjeti
Do not overtighten. 
Pazite da ga ne navijete prečvrsto.
Based on clinical trial data the inhalation powder TOBI Podhaler was associated with a higher reported rate of cough compared with tobramycin nebuliser solution (TOBI). 
Podhaler bio je povezan s većom prijavljenom stopom kašlja u usporedbi s tobramicin otopinom za nebulizator (TOBI).
Based on the interaction profile for tobramycin following intravenous and aerosolised administration, concurrent and/or sequential use of TOBI Podhaler is not recommended with other medicinal products with nephrotoxic or ototoxic potential. 
Na temelju profila interakcije za tobramicin nakon intravenske primjene i aerosolom, istodobna i/ili sekvencijska primjena TOBI
56 inhalation powder, hard capsules and 1 inhaler (weekly pack) 224 (4 x 56) inhalation powder, hard capsules and 5 inhalers (monthly multipack) 448 (8 x 56) inhalation powder, hard capsules and 10 inhalers (2 x monthly multipack wrapped in foil) 
56 prašak inhalata, tvrdih kapsula i 1 inhalator (tjedno pakiranje) 224 (4 x 56) prašak inhalata, tvrde kapsule i 5 inhalatora (mjesečno višestruko pakiranje)
Concomitant use of TOBI Podhaler with diuretic compounds (such as ethacrynic acid, furosemide, urea or intravenous mannitol) is not recommended. 
furosemid, urea ili intravenski manitol) se ne preporučuje.
Mylan Ireland Limited Tel: +353 87 1694982 
Tel: +353 87 1694982
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). 
To se mora uzeti u obzir prije propisivanja TOBI Podhalera, budući da je prašak inhalata TOBI
Discard the empty capsule. 
14. Bacite praznu kapsulu.
When the full dose (4 capsules) has been inhaled, wipe mouthpiece with a clean dry cloth. 
(4 kapsule), obrišite nastavak za usta čistom, suhom krpicom.
• Set the top of the case aside. 
• Odložite vrh spremnika sa strane.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING WEEKLY INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU TJEDNA UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA)
BGP Products s.r.o. 
BGP PRODUCTS SRL
Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. 
Unutar svakog organskog sustava nuspojave su poredane po učestalosti, od najučestalijih prema manje učestalim.
ON TOBI Podhaler OFF TOBI Podhaler 
UZ TOBI Podhaler BEZ TOBI Podhalera
When to take TOBI Podhaler 
Kada uzeti TOBI Podhaler
TOBI Podhaler 28 mg inhalation powder, hard capsules tobramycin 
TOBI Podhaler 28 mg prašak inhalata, tvrde kapsule tobramicin
Mylan Denmark ApS Tlf: +45 28 11 69 32 
Tlf: +45 28 11 69 32
1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) Calcium chloride 
1,2-distearoil-sn-glicero-3-fosfokolin (DSPC) kalcijev klorid sulfatna kiselina (za podešavanje pH)
• When you are ready, take your 2nd breath by repeating 
• Kad ste stpremni, napravite drugi udisaj ponavljajući korak 8 i koristeći istu kapsulu.
(To be displayed only on the inner lid of the intermediate carton of multipack) Read the package leaflet before use. 
(Navesti na unutrašnjosti poklopca unutarnje kutije višestrukog pakiranja) Prije uporabe pročitajte uputu o lijeku.
In the active-controlled open-label study, patients aged 20 years and older tended to discontinue more frequently with TOBI Podhaler than with the nebuliser solution; discontinuations due to adverse events accounted for about half of the discontinuations with each formulation. 
Podhalerom nego otopinom za nebulizator; prekidi uzrokovani štetnim događajima odnosili su se na oko polovinu prekida kod svake formulacije.
• Only use the capsules with the inhaler provided in this pack. 
• Kapsule koristite samo pomoću inhalatora priloženog u pakiranju.
Table 1 Adverse reactions Adverse reactions 
Tablica 1 Nuspojave Nuspojave
Oropharnygeal pain 
Orofaringealna bol
In a second open-label, multicentre study, patients received treatment with either TOBI Podhaler (112 mg) or tobramycin 300 mg/5 ml nebuliser solution (TOBI), administered twice daily for three cycles. 
(112 mg) ili tobramicin 300 mg/5 ml otopinom za nebulizator (TOBI), uz primjenu dvaput na dan kroz tri ciklusa.
Clear colourless capsules containing a white to almost white powder, with “NVR AVCI” printed in blue on one part of the capsule and Novartis logo printed in blue on the other part of the capsule. 
Prozirne bezbojne kapsule koje sadrže bijeli do gotovo bijeli prašak, s oznakom „NVR AVCI“
If your underlying lung disease seems worse while taking TOBI Podhaler, tell your doctor straight away. 
Ako Vam se čini da se Vaša osnovna plućna bolest pogoršava dok uzimate TOBI
Mylan Healthcare Norge AS Tlf: +47 66 75 33 00 
Tlf: +47 66 75 33 00
No reproduction toxicology studies have been conducted with tobramycin administered by inhalation. 
Nisu provedena ispitivanja toksičnosti inhalacijskog tobramicina na reproduktivnu funkciju.
(To be displayed only on the inner lid of the outer carton of multipack) Read the package leaflet before use. 
(Navesti na unutrašnjosti poklopca vanjske kutije višestrukog pakiranja) Prije uporabe pročitajte uputu o lijeku.
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). 
Opažen je numerički niži odgovor bolesnika u dobi ≥20 godina: promjena od početnog FEV1 opažena u bolesnika u dobi od ≥20 godina bila je manja
If you take more TOBI Podhaler than you should 
Ako uzmete više TOBI
Only TOBI Podhaler capsules are to be used in the Podhaler device. 
U uređaju Podhaler smiju se koristiti samo TOBI
The improvement in percent predicted FEV1 was numerically greater in the TOBI Podhaler treatment group and was statistically non-inferior to TOBI nebuliser solution. 
Poboljšanje u postotku predviđenog FEV1 bilo je numerički veće u terapijskoj skupini koja je uzimala TOBI
Treatment with TOBI Podhaler for 28 days resulted in a statistically significant reduction in P. aeruginosa sputum density (-1.61 log10 CFUs), as did the nebuliser solution (-0.77 log10 CFUs). 
P. aeruginosa u sputumu (-1,61 log10 CFUs), a isto je vrijedilo i za otopinu za nebulizator (-0,77 log10
After you have taken TOBI Podhaler for 28 days, you then have a 28-day break, during which you do not inhale any TOBI Podhaler. 
Podhaler imat ćete stanku od 28 dana tijekom koje ne udišete
(To be displayed only on the inner lid of the outer carton of unit pack) Read the package leaflet before use. 
(Navesti na unutrašnjosti poklopca vanjske kutije jediničnog pakiranja) Prije uporabe pročitajte uputu o lijeku.
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). 
P. aeruginosa otporne na intravenski tobramicin (vidjeti dio 5.1).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF UNIT PACK (INCLUDING BLUE BOX) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA JEDINIČNOG PAKIRANJA (S PLAVIM OKVIROM)
How to take TOBI Podhaler 
Kako uzeti TOBI Podhaler
These medicines may harm the kidneys or hearing. 
Vam oštetiti bubrege ili sluh.
10 and 11. 
28 dana