natgillin/translations-raw huggingface dataset:
Taking into account the PRAC Assessment Report on the PSUR(s) for glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone, the scientific conclusions of CHMP are as follows: 
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za glimepirid/pioglitazon hidroklorid,
Uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - gas - difficulty sleeping (insomnia) 
- vnetje sinusov (sinuzitis) - vetrovi - težave s spanjem (nespečnost)
Competact 15 mg/850 mg film-coated tablets pioglitazone/metformin hydrochloride 
Competact 15 mg/850 mg filmsko obložene tablete pioglitazon/metforminijev klorid
Inform your doctor as soon as possible if you develop symptoms suggesting a problem with your liver (like feeling sick without explanations, vomiting, stomach ache, tiredness, loss of appetite and/or dark urine) as your liver function should be checked. 
(kot je občutek slabosti brez razloga, bruhanje, bolečine v trebuhu, utrujenost, izguba apetita in/ali temen urin), ker je potrebno preveriti delovanje jeter.
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 - Cardiac failure or history of cardiac failure (NYHA stages I to IV) - Current bladder cancer or a history of bladder cancer - Uninvestigated macroscopic haematuria - Acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure, 
- akutnih ali kroničnih boleznih, ki so lahko vzrok hipoksije tkiv, npr. srčno ali respiratorno popuščanje, nedaven miokardni infarkt, šok;
(ACE) inhibitors and angiotensin II receptor antagonists) 
(COX) II, zaviralci angiotenzinske konvertaze (zaviralci ACE), antagonisti receptorjev angiotenzina II in diuretiki, zlasti diuretiki Henlejeve zanke.
14 Tablet blister 
filmsko obložena tableta 14 tablet
Posology 
Sre
Maximum daily dose is 2,000 mg. 
45 do 59 Največji dnevni odmerek je 2.000 mg.
Package leaflet: Information for the patient Competact 15 mg/850 mg film-coated tablets pioglitazone/metformin hydrochloride 
Navodilo za uporabo Competact 15 mg/850 mg filmsko obložene tablete pioglitazon/metforminijev klorid
Others 
Sob
Pioglitazone should be used with caution during concomitant administration of cytochrome P450 2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin). 
Pri sočasnem dajanju z zaviralci (npr. gemfibrozil) ali induktorji (npr. rifampicin) citokroma P450 2C8
recent myocardial infarction, shock - Hepatic impairment - Acute alcohol intoxication, alcoholism - Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) - Diabetic pre-coma - Severe renal failure (GFR < 30 mL/min) 
- huda ledvična odpoved (GFR < 30 ml/min); - akutnih stanjih, ki lahko spremenijo delovanje ledvic: dehidraciji; hudih okužbah; šoku;
Thu. 
Pon
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BELANETTE AND ASSOCIATED NAMES (see Annex I) 
ZAKLJUČNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA BELANETTE IN POVEZANIH IMEN (glejte Dodatek I)
The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure. 
Veljavni povzetek glavnih značilnosti zdravila, ovojnina in navodilo za uporabo so končne verzije besedil, sprejete med postopkom Koordinacijske skupine..
Therefore blind users will be able to double check the information written on the cardboard wallets (Braille text) with the information obtained from a physician (during the visit). 
Zato bodo slepi uporabniki lahko dodatno primerjali podatke, ki so zapisani na zloženkah iz lepenke (Braillova pisava) s podatki, ki so jih dobili od zdravnika (med obiskom).
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES 
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJ A ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
The Belanette blister is glued in a carton which is subsequently folded to a wallet configuration. 
Pretisni omot zdravila Belanette je prilepljen na lepenko, ki je zložena v obliko, podobno denarnici.
• If this happens, you may be able to feel these pieces on your tongue. 
• Če pride do tega, jih boste morda začutili na jeziku.
Date of first authorisation: 20 July 2011 Date of latest renewal: 18 February 2016 
Datum prve odobritve: 20. julij 2011 Datum zadnjega podaljšanja: 18. februar 2016
Take the other 3 capsules in the same way. 
Preostale 3 kapsule vzemite na enak način.
You then start another course. 
Nato začnete z novim krogom.
Data in different age groups 
Podatki v različnih starostnih skupinah
Taking your capsules at the same time each day will help you remember when to take them. 
Če boste jemali kapsule vsak dan ob istem času, si boste lažje zapomnili, kdaj jih morate vzeti.
Some people do not get this infection until later on in their lives, while others get it very young. 
Nekateri ljudje se okužijo šele v kasnejšem obdobju življenja, drugi pa že zelo mladi.
Tell your doctor if you have ever had any of the following conditions: 
Posvetujte se z zdravnikom, če ste imeli kdaj prej katero od naslednjih težav:
It should appear pierced and empty. 
Videti morate, da je predrta in prazna.
Cough was not related to bronchospasm. 
Kašelj ni bil povezan z bronhospazmom.
People with cystic fibrosis have many symptoms of the disease. 
Ljudje s cistično fibrozo imajo številne simptome te bolezni.
Elderly patients (≥65 years) 
Starejši bolniki (stari 65 let ali več)
The dose is the same for everyone aged 6 years and older. 
Odmerek je enak za vse bolnike, ki so stari 6 let ali več.
Patients after organ transplantation 
Bolniki po presaditvi organa
• You are now ready to inhale the capsule in 2 separate breaths (Steps 8 and 9). 
• Zdaj ste pripravljeni za inhaliranje vsebine kapsule z dvema ločenima vdihoma (koraka št. 8 in 9).
The frequencies in Table 1 are based on the reporting rates from the active-controlled study. 
Pogostnosti v preglednici 1 temeljijo na pogostnosti poročil v aktivno kontrolirani študiji.
Consideration should be given to official guidance on the appropriate use of antibacterial agents. 
Pri zdravljenju je treba upoštevati uradne smernice o ustrezni uporabi antibakterijskih sredstev.
• Cough, productive cough, voice alteration (hoarseness) 
• kašelj, produktiven kašelj, sprememba glasu (hripavost)
• Do not use this medicine after the expiry date which is stated on the box or capsule card. 
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali tablici s kapsulami.
The hard capsules are supplied in PVC/PA/Alu/PVC- PET/Alu blisters. 
Trde kapsule so na voljo v PVC/PA/Alu/PVC- PET/Alu pretisnih omotih.
• 7 capsule cards (one card for each day of the week). 
• 7 tablic s kapsulami (ena tablica za vsak dan v tednu),
Use this if your weekly inhaler is not functioning correctly, is wet, or has dropped on the ground. 
Uporabite ga v primeru, če inhalator iz tedenskega pakiranja ne deluje pravilno, je moker ali pade na tla.
Tell your doctor or a pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. 
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
What is Pseudomonas aeruginosa 
Kaj je Pseudomonas aeruginosa
In the active-controlled study, audiology testing was performed in selected centres accounting for about a quarter of the study population. 
V aktivno kontrolirani študiji so preiskave sluha izvajali v izbranih študijskih centrih, opravila jih je približno četrtina bolnikov vključenih v študijo.
4 capsules = 1 dose 
4 kapsule = 1 odmerek
Occasionally, very small pieces of the capsule can get past the screen and get into your mouth. 
Občasno lahko zelo majhni delci kapsule zaidejo skozi mrežico v usta.
• Coughing up blood (very common) 
• izkašljevanje krvi (zelo pogosto)
• Decreasing hearing (ringing in the ears is a potential warning sign of hearing loss), noises (such as hissing) in the ears (common). 
• slabšanje sluha (zvenenje v ušesih je lahko opozorilni znak slabšanja sluha), zvoki (kot je sikanje) v ušesih (pogosti)
It is not known whether inhaling this medicine when you are pregnant causes side effects. 
Ni znano, ali inhaliranje tega zdravila med nosečnostjo povzroča neželene učinke.
Keep it dry and store it in its case. 
Pazite, da ostane suh, in ga shranjujte v etuiju.
Mylan IRE Healthcare Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 Ireland 
Mylan IRE Healthcare Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 Irska
Basic instructions for use are given below, more detailed instructions are available from the patient leaflet. 
Spodaj so podana osnovna navodila za uporabo, bolj podrobna navodila pa so na voljo v Navodilu za uporabo.
Otherwise, the patient should wait for the next dose and not inhale more capsules to make up for the missed dose. 
V nasprotnem primeru mora bolnik počakati na naslednji odmerek in ne sme inhalirati več kapsul, da bi nadomestil izpuščeni odmerek.
FOUR capsules are required for ONE complete dose. 
Za EN celoten odmerek potrebujete ŠTIRI kapsule.
Patients in this study had no exposure to inhaled tobramycin for at least 4 months prior to study start. 
Bolniki v tej študiji najmanj 4 mesece pred začetkom študije niso bili izpostavljeni inhalacijskemu tobramicinu.
Monthly pack. 
Mesečno pakiranje.
2 x monthly multipack wrapped in foil 
2 x mesečno pakiranje, zavito v folijo
In the open label extensions, each additional 6 months of treatment resulted in incremental increases similar in magnitude to that observed in the 6 months of placebo-controlled studies. 
V odprtih podaljšanjih študij je v vsakem dodatnem 6-mesečnem obdobju zdravljenja prišlo do zvišanja podobnega obsega kot v 6 mesecih v študijah, kontroliranih s placebom
See also information on clinical benefit and tolerability in sections 4.4, 4.8 and 5.1. 
Glejte tudi podatke o kliničnih koristih in prenosljivosti v poglavjih 4.4, 4.8 in 5.1.
• muscle weakness that lasts or becomes worse over time, a symptom mostly related to conditions such as myasthenia or Parkinson's disease. 
• šibkost mišic, ki vztraja ali se sčasoma še slabša, kar je večinoma simptom pri boleznih, kot sta miastenija ali Parkinsonova bolezen.
Your doctor will supervise your first dose of TOBI Podhaler and check your lung function before and after dosing. 
Zdravnik bo nadzoroval vaše prvo odmerjanje zdravila TOBI Podhaler in preveril vašo pljučno funkcijo pred odmerjanjem zdravila in po njem.
• hearing problems (including noises in the ears and dizziness) 
• težave s sluhom (vključno z različnimi zvoki v ušesih in z omotičnostjo),
ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
224 capsules + 5 inhalers 
224 kapsul + 5 inhalatorjev
The variability in pharmacokinetic parameters was higher in sputum as compared to serum. 
Variabilnost farmakokinetičnih parametrov je bila večja v izpljunku kot v serumu.
Should cough remain unchanged, other antibiotics should be considered. 
Če glede kašlja ne pride do sprememb, je treba razmisliti o uporabi drugih antibiotikov.
• blood in your sputum (the substance you cough up) 
• kri v izpljunku (v vsebini, ki jo izkašljate),
These may still happen while taking TOBI Podhaler, but should not be any more frequent or seem worse than before. 
Ti simptomi so lahko prisotni tudi v obdobju jemanja zdravila TOBI Podhaler, vendar ne bi smeli biti bolj pogosti ali bolj izraziti kot prej.
Tear the perforations along the length then width: see Figures (a) and (b). 
Trgajte po perforaciji najprej po dolžini in nato po širini: glejte sliki (a) in (b).
Wash and fully dry your hands. 
Roke si umijte in jih temeljito osušite.
If the infection is not properly fought, it will continue to damage your lungs, causing further problems to your breathing. 
Če okužbe ne bi ustrezno zdravili, bi ta še naprej kvarila pljuča in tako povzročala nadaljnje težave z dihanjem.
The dose of TOBI Podhaler is the same for all patients within the approved age range, regardless of age or weight. 
Odmerek zdravila TOBI Podhaler je v odobrenem starostnem okviru enak za vse bolnike, ne glede na starost ali telesno maso.
See also section 4.2. 
Glejte tudi poglavje 4.2.
Your doctor may ask you to use other appropriate medicines before taking TOBI Podhaler. 
Zdravnik vas bo morda prosil, da vzamete druga ustrezna zdravila pred uporabo zdravila TOBI Podhaler.
Unscrew mouthpiece (1) and remove the capsule from the chamber (2). 
Odvijte ustnik (1) in vzemite kapsulo iz ležišča (2).
See also information on previous and concomitant use of systemic aminoglycosides and diuretics in section 4.4. 
Glejte tudi podatke o predhodni in sočasni uporabi sistemskih aminoglikozidov in diuretikov v poglavju 4.4.
TOBI Podhaler should not be given to children less than 6 years old. 
Zdravila TOBI Podhaler ne smejo prejemati otroci, ki so stari manj kot 6 let.
Do not use each inhaler and its case for longer than 1 week. 
Posameznega inhalatorja z etuijem ne uporabljajte več kot 1 teden.
The Podhaler inhalation device and its storage case are made from plastic materials (polypropylene). 
Inhalator Podhaler in njegov zaščitni etui sta izdelana iz plastičnih materialov (iz polipropilena).
Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. 
V okviru vsakega organskega sistema so neželeni dogodki razvrščeni po pogostnosti, pri čemer so najprej navedeni najbolj pogosti učinki.
Haemoptysis is a complication in cystic fibrosis and is more frequent in adults. 
Hemoptiza je zaplet pri cistični fibrozi in je bolj pogosta pri odraslih.
The main resistance mechanisms are drug efflux and drug inactivation by modifying enzymes. 
Glavna mehanizma rezistence sta izločanje zdravila in inaktivacija zdravila z encimi, ki ga modificirajo.
The following medicines can increase the chances of harmful effects occurring if they are given to you while you are also receiving injections of tobramycin or other aminoglycoside antibiotic: 
Naslednja zdravila lahko povečajo možnost, da pride do škodljivega delovanja, če jih prejemate v času, ko se zdravite tudi z injekcijami tobramicina ali drugih aminoglikozidnih antibiotikov:
Pharmacotherapeutic group: Antibacterials for systemic use, Aminoglycoside antibacterials, ATC Code: J01GB01 
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje bakterijskih infekcij, aminoglikozidni antibiotiki, oznaka ATC: J01GB01
There are no adequate data on the use of tobramycin via inhalation in pregnant women. 
Ni zadostnih podatkov o uporabi tobramicina z inhalacijo pri nosečnicah.
This analysis did not show gender or age-related pharmacokinetic differences 
Pri tej analizi se ni pokazalo, da bi se farmakokinetične lastnosti razlikovale v odvisnosti od spola ali starosti.
If you are aged 65 years or older, your doctor may perform additional tests to decide if TOBI Podhaler is right for you. 
Če ste stari 65 let ali več, bo zdravnik morda pri vas opravil dodatne preiskave, da bi ugotovil, ali je zdravilo TOBI Podhaler za vas primerno.
Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function. 
Aminoglikozidi lahko še dodatno poslabšajo šibkost mišic, saj lahko na živčno-mišično funkcijo delujejo podobno kot kurare.
Do not take the capsules out of the card in advance. 
Kapsul ne jemljite iz tablice vnaprej.
• Look at the inhaler to make sure it is not damaged or dirty. 
• Preglejte inhalator in se prepričajte, da ni poškodovan ali umazan.
Tobramycin is eliminated from the systemic circulation primarily by glomerular filtration of the unchanged compound. 
Tobramicin se izloča iz sistemskega obtoka predvsem z glomerulno filtracijo nespremenjene spojine.
These medicines may cause muscle weakness to appear or become worse.. 
Navedena zdravila lahko povzročajo mišično šibkost ali njeno poslabšanje.
• The chances of the capsule breaking into pieces will be increased if the capsule is accidentally pierced more than once or if the device is not held with the mouthpiece pointing down during step 7. 
• Možnost, da se kapsula tako zdrobi, je večja, če kapsulo pri koraku št. 7 nehote predrete več kot enkrat ali če inhalatorja pri tem ne držite z ustnikom navzdol.
Ask your pharmacist how to dispose of medicines and inhalers no longer required. 
Pri farmacevtu se pozanimajte, kako lahko zavržete zdravila in inhalatorje, ki jih ne potrebujete več.
• So for each remaining capsule, repeat steps 5,6, 7, 8, 9, 
• Za vsako od preostalih kapsul ponovite korake št. 5, 6,
10 and 11. 
7, 8, 9, 10 in 11.
common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare 
Poleg tega je za vsak neželeni učinek navedena tudi ustrezna kategorija pogostnosti v skladu z naslednjim dogovorom (CIOMS III): zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000); pogostnost neznana (je ni mogoče oceniti iz razpoložljivih podatkov).
Always store inhaler in its case. 
Inhalator vedno shranjujte v njegovem etuiju.
Remove the inhaler from your mouth, and hold your breath for about 5 seconds. 
Inhalator odmaknite od ust in približno 5 sekund zadržujte dih.
Based on available data from animals a risk of toxicity (e.g. ototoxicity) at prenatal exposure levels cannot be excluded. 
Na osnovi dostopnih podatkov iz študij na živalih ni mogoče izključiti tveganja za toksično delovanje (na primer za ototoksičnost) pri stopnji izpostavljenosti v času pred rojstvom.
• Other medicines which may harm your kidneys or hearing. 
• drugih zdravil, ki lahko škodujejo ledvicam ali sluhu.
Inhale the powder deeply with a single breath. 
Z enim vdihom globoko inhalirajte prašek.
• The active substance is tobramycin. 
• Učinkovina je tobramicin.
Briefly inspect the inhaler to make sure it is not damaged or dirty. 
Na hitro preglejte inhalator in se prepričajte, da ni poškodovan ali umazan.
Lift here to open. 
Odprite tu.
In addition, all patients were infected with P. aeruginosa as demonstrated by a positive sputum or throat culture (or bronchoalveolar lavage) within 6 months prior to screening, and also in a sputum culture taken at the screening visit. 
Vsi bolniki so bili okuženi z bakterijo P. aeruginosa, kar je pokazal pozitiven izvid kulture izpljunka ali kulture iz žrela (ali bronhoalveolarne lavaže) v 6 mesecih pred začetnim obiskom in pozitiven izvid kulture izpljunka, odvzet pri začetnem obisku.
Clinical experience 
KLINIČNI PODATKI
If you forget to take TOBI Podhaler and there are at least 6 hours to your next dose, take your dose as soon as you can. 
Če ste pozabili vzeti zdravilo TOBI Podhaler in je do naslednjega odmerka več kot 6 ur, vzemite odmerek takoj, ko ga lahko.
Severely maternally toxic doses to female rabbits (i.e. nephrotoxicity) lead to spontaneous abortions and death. 
Odmerki, ki so delovali zelo toksično na samice kuncev (in sicer nefrotoksično), so povzročili spontane splave in smrt pri zarodkih.
Hypersensitivity to the active substance and any aminoglycoside, or to any of the excipients listed in section 6.1. 
Preobčutljivost na učinkovino in katerikoli aminoglikozid ali katero koli pomožno snov, navedeno v poglavju 6.1.
For safety results see section 4.8 
Za rezultate glede varnosti zdravila glejte poglavje 4.8.
• Anticholinesterases such as neostigmine and pyridostigmine (used to treat muscle weakness), or botulinum toxin. 
• antiholinesteraze, kot sta neostigmin in piridostigmin (za zdravljenje mišične šibkosti), ali botulinski toksin.
56 capsules and 1 inhaler 
56 kapsul in 1 inhalator
If you have questions about how long to take TOBI Podhaler for, talk to your doctor or your pharmacist. 
Če imate vprašanja glede tega, kako dolgo jemati zdravilo TOBI Podhaler, se obrnite na zdravnika ali farmacevta.
Inspect the used capsule. 
Preglejte uporabljeno kapsulo.
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. 
V študijo, kontrolirano s placebom, so bili vključeni bolniki, ki so bili stari 6 - ≤22 let, njihov FEV1 pa je bil ob začetnem obisku med 25 % in 84 % napovedane normalne vrednosti za njihovo starost, spol in telesno višino po Knudsonovih kriterijih.
Systemic exposure following inhalation of TOBI Podhaler is very low, however TOBI Podhaler should not be used during pregnancy unless clearly necessary, i.e. when the benefits to the mother outweigh the risks to the foetus. 
Sistemska izpostavljenost zdravilu TOBI Podhaler po inhalaciji je sicer majhna, vendar se zdravila TOBI Podhaler ne sme uporabljati med nosečnostjo, razen če je nujno potrebno, torej le v primeru, da koristi za mater presegajo tveganja za plod.
After this if the capsule is still full and appears to be unpunctured, replace the inhaler with the reserve inhaler and try again. 
Če je kapsula po tem poskusu še vedno polna in ni videti predrta, zamenjajte inhalator z rezervnim in poskusite znova.
Serum concentrations greater than 12 µg/ml are associated with tobramycin toxicity and treatment should be discontinued if concentrations exceed this level. 
Pri koncentracijah, ki presegajo 12 µg/ml, prihaja do toksičnega delovanja tobramicina, zato je treba zdravljenje prekiniti, če koncentracija presega to vrednost.
It is a very common bacterium that infects the lungs of nearly everyone with cystic fibrosis at some time during their lives. 
To je zelo pogosta bakterija, ki pri skoraj vsakem posamezniku s cistično fibrozo prej ali slej v življenju povzroči okužbo pljuč.
Inhale the content of 4 capsules twice a day (4 capsules in the morning and 4 capsules in the evening), using the Podhaler device. 
Inhalirajte vsebino 4 kapsul dvakrat na dan (4 kapsule zjutraj in 4 kapsule zvečer), in sicer s pomočjo inhalatorja Podhaler.
After a few normal breaths away from the inhaler, perform a second inhalation from the same capsule. 
Po nekaj normalnih vdihih in izdihih stran od inhalatorja izvedite še drugi vdih iz iste kapsule.
TOBI Podhaler significantly improved lung function compared with placebo, as shown by the relative increase in percent predicted FEV1 of about 13% after 28 days of treatment. 
Zdravilo TOBI Podhaler je statistično značilno izboljšalo pljučno funkcijo v primerjavi s placebom, kar dokazuje relativno povečanje odstotka napovedane vrednosti FEV1 za približno 13 % po 28 dneh zdravljenja.
• Platinum compounds such as carboplatin and cisplatin (used to treat some forms of cancer). 
• zdravila, ki vsebujejo platino, kot sta karboplatin in cisplatin (za zdravljenje nekaterih vrst raka).
In case of missed dose with at least 6 hours until the next dose, the patient should take the dose as soon as possible. 
Če bolnik izpusti odmerek in je do naslednjega odmerka še najmanj 6 ur, naj bolnik vzame odmerek čimprej.
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%. 
V aktivno kontroliranih študijah so bili vsi bolniki stari več kot 6 let (od 6 do 66 let), njihov FEV1 pa je bil ob začetnem obisku med 24 % in 76 % napovedane vrednosti.
In the active-controlled study, administration of a TOBI Podhaler dose was faster with a mean difference of approximately 14 minutes (6 minutes vs. 20 minutes with the nebuliser solution). 
V aktivno kontrolirani študiji je bila aplikacija odmerka zdravila TOBI Podhaler hitrejša s povprečno razliko približno 14 minut (6 minut v primerjavi z 20 minutami apliciranja raztopine za nebulator).