FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Analiza populacijske farmakokinetike za TOBI Podhaler u bolesnika s cističnom fibrozom procijenila je prividni volumen distribucije tobramicina u središnjem odjeljku na 84,1 litru za tipičnog bolesnika s
English: TOBI Podhaler is supplied in monthly packs containing 4 weekly cartons and a reserve Podhaler device in its storage case.
Croatian: TOBI Podhaler pakiran je u mjesečnim pakiranjima koja sadrže 4 tjedne kutije i rezervni inhalator Podhaler u svom spremniku.
English: A population pharmacokinetic analysis for TOBI Podhaler in cystic fibrosis patients aged 6 to 66 years estimated the apparent serum clearance of tobramycin to be 14 litres/h.
Croatian: Analiza populacijske farmakokinetike za TOBI Podhaler u bolesnika s cističnom fibrozom u dobi od 6 do 66 godina procijenila je prividni klirens tobramicina iz seruma na 14 litara/h.
English: One capsule contains 28 mg tobramycin.
Croatian: Jedna kapsula sadrži 28 mg tobramicina.
English: • When you start a new weekly pack of capsules, use the new Podhaler device that is supplied in the pack.
Croatian: • Kada otvorite novo tjedno pakiranje kapsula, upotrijebite novi uređaj Podhaler koji je priložen u pakiranju.
English: See also section 4.2 and “Monitoring of serum tobramycin concentrations” below.
Croatian: Vidjeti također dio 4.2 i „Praćenje koncentracije tobramicina u serumu“ u nastavku.
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
Croatian: Što je TOBI Podhaler i za što se koristi Što morate znati prije nego počnete uzimati TOBI Podhaler Kako uzimati TOBI Podhaler
English: The use of TOBI Podhaler in patients with clinically significant haemoptysis should be undertaken or continued only if the benefits of treatment are considered to outweigh the risks of inducing further haemorrhage.
Croatian: Podhalera u bolesnika s klinički značajnom hemoptizom treba započeti ili nastaviti samo ako se smatra da koristi liječenja premašuju rizike od izazivanja daljnjeg krvarenja.
English: Strains of Pseudomonas can become resistant to treatment with an antibiotic over time.
Croatian: Pseudomonas tijekom vremena mogu postati otporni na liječenje.
English: Patientreported convenience and overall treatment satisfaction (as collected through a patient-reported outcomes questionnaire) were consistently higher with TOBI Podhaler compared with tobramycin nebuliser solution in each cycle.
Croatian: Praktičnost i općenito zadovoljstvo liječenjem prema prijavama bolesnika (prikupljenima kroz upitnike za bolesnike o ishodima) bili su dosljedno viši s TOBI Podhalerom u usporedbi s tobramicin otopinom za nebulizator u svakom ciklusu.
English: Mylan IRE Healthcare Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 Ireland
Croatian: Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13
English: TOBI Podhaler capsules must not be swallowed.
Croatian: TOBI Podhaler kapsule se ne smiju gutati.
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.
Croatian: TOBI Podhaler je indiciran za supresivno liječenje kronične plućne infekcije uzrokovane bakterijom Pseudomonas aeruginosa u odraslih i djece u dobi od 6 i više godina s cističnom fibrozom.
English: Adequate data do not exist for the use of TOBI Podhaler in patients after organ transplantation.
Croatian: Ne postoje primjereni podaci za primjenu TOBI Podhalera u bolesnika nakon presađivanja organa.
English: The systemic exposure to tobramycin after inhalation of TOBI Podhaler is expected to be primarily from the inhaled portion of the medicinal product as tobramycin is not absorbed to any appreciable extent when administered via the oral route.
Croatian: Očekuje se da će sistemska izloženost tobramicinu nakon inhalacije TOBI Podhalera u prvom redu biti iz inhaliranog dijela lijeka, budući da se tobramicin ne apsorbira u značajnoj mjeri kada se primjenuje peroralnim putem.
English: Each weekly carton contains 56 x 28 mg capsules (7 blisters with 8 capsules per blister), and a Podhaler device in its storage case.
Croatian: Svaka tjedna kutija sadrži 56 x 28 mg kapsula (7 blistera s 8 kapsula po blisteru), i uređaj Podhaler u svom spremniku.
English: Do not push capsule through foil.
Croatian: Ne gurati kapsulu kroz foliju.
English: MIC increases observed were in large part reversible during offtreatment periods.
Croatian: Uočena povišenja MIK-a velikim su dijelom bila reverzibilna tijekom razdoblja neuzimanja terapije.
English: • Never blow into the mouthpiece of the device.
Croatian: • Nikada ne pušite u nastavak za usta na uređaju.
English: If a patient reports tinnitus or hearing loss during TOBI Podhaler therapy the physician should consider referring them for audiological assessment.
Croatian: Ako bolesnik prijavi tinitus ili gubitak sluha tijekom terapije TOBI Podhalerom, liječnik treba razmotriti upućivanje tog bolesnika na audiološku obradu.
English: If there is evidence of continued therapy-induced cough with TOBI Podhaler, the physician should consider whether an approved tobramycin nebuliser solution should be used as an alternative treatment.
Croatian: Ako postoje dokazi o kontinuiranom kašlju izazvanom terapijom TOBI Podhalerom, liječnik treba razmotriti odobrenu tobramicin otopinu za nebulizator kao alternativnu terapiju.
English: The Podhaler inhalation device and its storage case are made from plastic materials (polypropylene).
Croatian: Podhaler inhalator i spremnik za njegovo čuvanje napravljeni su od plastičnih materijala
English: If you are breast feeding, you should talk to your doctor before taking this medicine.
Croatian: Ako dojite, obratite se svom liječniku prije uzimanja ovog lijeka.
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:
Croatian: Na osnovi in vitro podataka i/ili iskustava iz kliničkih ispitivanja, može se očekivati sljedeća osjetljivost organizama povezanih s plućnim infekcijama kod CF-a na TOBI Podhaler: Osjetljivi
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.
Croatian: Da biste probušili kapsulu, držite inhalator s nastavkom za usta okrenutim prema dolje, čvrsto pritisnite tipku palcem do kraja i zatim otpustite tipku.
English: • Do not press the piercing button more than once at a time.
Croatian: • Ne pritišćite tipku za probijanje kapsule više od jedanput.
English: • Put the capsule back into the inhaler chamber (step 6)
Croatian: • Vratite kapsulu u komoru inhalatora (korak 6)
English: Inhalation powder, hard capsules 56 capsules + 1 inhaler
Croatian: Prašak inhalata, tvrde kapsule 56 kapsula + 1 inhalator
English: Pseudomonas aeruginosa Haemophilus influenzae Staphylococcus aureus Insusceptible Burkholderia cepacia Stenotrophomonas maltophilia Alcaligenes xylosoxidans
Croatian: Burkholderia cepacia Stenotrophomonas maltophilia Alcaligenes xylosoxidans
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.
Croatian: Ako izgleda da kapsula nije probušena, vratite je u inhalator, čvrsto pritisnite tipku do kraja i napravite još dvije inhalacije iz kapsule.
English: Inhaling medicines can cause chest tightness and wheezing and this can happen immediately after inhalation of TOBI Podhaler.
Croatian: Inhalacija lijekova može uzrokovati stezanje u prsnom košu i piskanje, a to se može dogoditi odmah nakon inhalacije TOBI Podhalera.
English: • When you start a new weekly pack of capsules, use the new inhaler that is supplied in the pack.
Croatian: • Kada otvorite novo tjedno pakiranje kapsula, upotrijebite novi inhalator koji je priložen u pakiranju.
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.
Croatian: Nadalje, postignuto je poboljšanje od 6% u postotku predviđenog FEV1 u oko 30% odraslih bolesnika u skupini koja je primala TOBI Podhaler u odnosu na 36% onih koji su primali TOBI otopinu za nebulizator.
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.
Croatian: Na kraju 4-tjednog ciklusa doziranja TOBI Podhalera (112 mg dvaput na dan), maksimalna koncentracija tobramicina u serumu 1 sat nakon doze bila je 1,99 ± 0,59 µg/ml.
English: Before putting the mouthpiece in your mouth, breathe out fully, away from the inhaler.
Croatian: Prije nego što u usta stavite nastavak za usta, izdahnite do kraja i to dalje od inhalatora.
English: • 4 capsules in the morning to be inhaled using the Podhaler device.
Croatian: • 4 kapsule ujutro koje se inhaliraju uz korištenje Podhaler uređaja.
English: Always store inhaler in its case.
Croatian: Inhalator uvijek čuvati u njegovom spremniku.
English: • 4 capsules in the evening to be inhaled using the Podhaler device.
Croatian: • 4 kapsule uvečer koje se inhaliraju uz korištenje Podhaler uređaja.
English: 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).
Croatian: Podhalera bila je brža uz srednju vrijednost razlike od otprilike 14 minuta (6 minuta u odnosu na 20 minuta s otopinom za nebulizator).
English: • Discard all the empty capsules.
Croatian: • Uklonite sve prazne kapsule.
English: If TOBI Podhaler is swallowed, don't worry but tell your doctor as soon as possible.
Croatian: Ako progutate TOBI Podhaler, ne brinite ali što prije to recite svom liječniku.
English: • Do not swallow TOBI Podhaler capsules.
Croatian: • Ne gutajte kapsule TOBI Podhaler.
English: In patients with a predisposing risk due to previous prolonged, systemic aminoglycoside therapy it may be necessary to consider renal and audiological assessment before initiating TOBI Podhaler therapy.
Croatian: bolesnika s predisponirajućim rizikom uzrokovanim prethodnom produljenom sistemskom terapijom aminoglikozidima moglo bi biti potrebno razmotriti bubrežne i audiološke pretrage prije početka terapije TOBI Podhalerom.
English: Adult patients tended to discontinue more frequently for tolerability reasons with TOBI Podhaler than with the nebuliser solution.
Croatian: Odrasli bolesnici bili su skloniji učestalijim prekidima liječenja zbog manje podnošljivosti s TOBI Podhalerom nego s otopinom za nebulizator.
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.
Croatian: (kao FEV1% predviđenog), simulacije temeljene na modelu pokazale su da na vršne (Cmax) i najniže (Ctrough) koncentracije nisu znatno utjecale promjene BMI-ja ili plućne funkcije.
English: Productive cough
Croatian: Produktivan kašalj
English: Each hard capsule contains 28 mg tobramycin.
Croatian: Svaka tvrda kapsula sadrži 28 mg tobramicina.
English: • Never place a TOBI Podhaler capsule directly into the mouthpiece of the device.
Croatian: • Nikad ne stavljajte TOBI Podhaler kapsulu izravno u nastavak za usta na uređaju.
English: It is bactericidal at concentrations equal to or slightly greater than inhibitory concentrations.
Croatian: U koncentracijama koje su jednake ili malo veće od inhibitornih koncentracija djeluje baktericidno.
English: Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected auditory or vestibular dysfunction.
Croatian: Potreban je oprez kod propisivanja TOBI Podhalera bolesnicima s potvrđenom ili suspektnom auditivnom ili vestibularnom disfunkcijom.
English: Set the mouthpiece aside on a clean, dry surface.
Croatian: Odložite nastavak za usta sa strane na čistu, suhu površinu.
English: The powder in the capsules is for you to inhale.
Croatian: Prašak u kapsulama namijenjen je za udisanje.
English: Tobramycin is primarily excreted unchanged in the urine and renal function is expected to affect the exposure to tobramycin.
Croatian: Tobramcin se prvenstveno izlučuje nepromijenjen u mokraći pa se očekuje da će bubrežna funkcija utjecati na izloženost tobramicinu.
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Ototoksičnost
English: • Do not wash the inhaler with water.
Croatian: • Ne perite inhalator vodom.
English: How much TOBI Podhaler to take
Croatian: Koliko TOBI Podhalera uzeti
English: • Set the mouthpiece aside on a clean, dry surface.
Croatian: • Odložite nastavak za usta na čistu, suhu površinu.
English: Reinspect capsule.
Croatian: Ponovno provjerite kapsulu.
English: Inhale the capsule - 2nd breath:
Croatian: Inhalirajte kapsulu - drugi udisaj:
English: • Put the capsule back into the inhaler chamber (step 6).
Croatian: • Vratite kapsulu u komoru inhalatora (korak 6).
English: A majority of the patients were tobramycin-experienced adults with chronic pulmonary P. aeruginosa infection.
Croatian: Većina bolesnika bili su odrasle osobe s kroničnom plućnom infekcijom P. aeruginosa koji su već imali iskustva s tobramicinom.
English: What TOBI Podhaler is and what it is used for What TOBI Podhaler is
Croatian: Što je TOBI Podhaler i za što se koristi Što je TOBI
English: Established susceptibility breakpoints for parenteral administration of tobramycin are inappropriate in the aerosolised administration of the medicinal product.
Croatian: Ustanovljene granice osjetljivosti za parenteralnu primjenu tobramicina ne odgovaraju onima kod primjene lijeka aerosolom.
English: Unscrew mouthpiece and remove the capsule from the chamber.
Croatian: Odvijte nastavak za usta i izvadite kapsulu iz komore.
English: 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.
Croatian: 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.
English: • Fever
Croatian: • Vrućicu
English: If this applies to you, tell your doctor without taking TOBI Podhaler.
Croatian: Ako se to odnosi na Vas, obavijestite svog liječnika i nemojte uzimati TOBI Podhaler.
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.
Croatian: Podhaler dođe do ototoksičnosti ili nefrotoksičnosti, potrebno je prekinuti terapiju tobramicinom dok koncentracija u serumu ne padne ispod 2 µg/ml.
English: • 1 inhaler (the Podhaler device) and its storage case.
Croatian: • 1 inhalator (uređaj Podhaler) sa spremnikom za čuvanje.
English: Inhale the capsule - 1st breath:
Croatian: Inhalirajte kapsulu - prvi udisaj:
English: Just before use, remove the Podhaler device from its case.
Croatian: Neposredno prije primjene izvadite uređaj Podhaler iz spremnika.
English: • Replace the mouthpiece and repeat Steps 7, 8 and 9.
Croatian: • Vratite nastavak za usta i ponovite korake 7, 8 i 9.
English: • 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.
Croatian: • Netom prije uporabe izvadite inhalator iz spremnika tako da držite dno i odvrnete vrh spremnika u smjeru suprotnom od kazaljke na satu.
English: 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%.
Croatian: U aktivno kontroliranim ispitivanjima svi su bolesnici imali >6 godina (raspon 6-66 godina)
English: 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.
Croatian: Ako se utvrdi postojanje bronhospazma izazvanog terapijom, liječnik mora pažljivo ocijeniti premašuju li koristi od korištenja TOBI Podhalera rizike za bolesnika.
English: The maximum tolerated daily dose of TOBI Podhaler has not been established.
Croatian: Najveća podnošljiva dnevna doza TOBI
English: How to store TOBI Podhaler Contents of the pack and other information Instructions for use with the Podhaler device (overleaf)
Croatian: Sadržaj pakiranja i druge informacije Upute za uporabu s uređajem Podhaler (na drugoj strani)
English: Inhalation powder, hard capsules Multipack: 448 capsules (2 packs of 224 + 5 inhalers)
Croatian: Prašak inhalata, tvrde kapsule Višestruko pakiranje: 448 kapsula (2 pakiranja od 224 + 5 inhalatora)
English: If you inhale too much TOBI Podhaler, tell your doctor as soon as possible.
Croatian: Ako inhalirate previše TOBI Podhalera, što prije se obratite svom liječniku.
English: Mylan Finland Oy Puh/Tel: +358 20 720 9555
Croatian: Puh/Tel: +358 20 720 9555
English: • Always keep the TOBI Podhaler capsules and device in a dry place.
Croatian: • Uvijek čuvajte TOBI Podhaler kapsule i uređaj na suhom mjestu.
English: Contains 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), calcium chloride and sulphuric acid (for pH adjustment).
Croatian: Sadrži 1,2-distearoil-sn-glicero-3-fosfokolin (DSPC), kalcijev klorid i sulfatnu kiselinu (za podešavanje pH).
English: Each weekly carton contains 7 blisters (capsule cards) of 8 capsules each, and a Podhaler device in its storage case.
Croatian: Svaka tjedna kutija sadrži 7 blistera (kartica s kapsulama) od po 8 kapsula, te uređaj Podhaler u svojem spremniku za čuvanje.
English: If you forget to take TOBI Podhaler
Croatian: Ako ste zaboravili uzeti TOBI Podhaler
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.
Croatian: Ako uzimate nekoliko različitih inhalacijskih lijekova kao i drugu terapiju za cističnu fibrozu, TOBI
English: TOBI Podhaler capsules must always be stored in the blister to protect from moisture and only removed immediately before use.
Croatian: TOBI Podhaler kapsule uvijek se moraju čuvati u blisteru radi zaštite od vlage te izvaditi tek neposredno prije primjene.
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.
Croatian: Podhalera mora dati pod nadzorom, nakon uporabe bronhodilatatora ako je to dio terapije koju bolesnik trenutačno prima.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MONTHLY INTERMEDIATE CARTON OF MULTIPACK COMPRISING 2 MONTHLY PACKS, EACH CONTAINING 4 WEEKLY PACKS) (WITHOUT BLUE BOX)
Croatian: 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)
English: Store the Podhaler device in its tightly closed case when not in use.
Croatian: Čuvajte uređaj Podhaler u njegovom čvrsto zatvorenom spremniku kada se ne koristi.
English: • Amphotericin B, cefalotin, polymyxins (used to treat microbial infections), ciclosporin, tacrolimus (used to reduce the activity of immune system).
Croatian: • Amfotericin B, cefalotin, polimiksini (koji se koriste za liječenje mikrobnih infekcija),
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.
Croatian: antibiotik može ući izravno u Vaša pluća kako bi se borio protiv bakterija koje uzrokuju infekciju te
English: Nephrotoxicity was not observed during TOBI Podhaler clinical studies.
Croatian: Nefrotoksičnost nije uočena tijekom kliničkih ispitivanja TOBI Podhalera.
English: In the event of accidental oral ingestion of TOBI Podhaler capsules, toxicity is unlikely as tobramycin is poorly absorbed from an intact gastrointestinal tract.
Croatian: Podhaler kapsula, mala je vjerojatnost toksičnosti budući da se tobramicin slabo apsorbira iz intaktnog gastrointestinalnog trakta.
English: Place inhaler back in storage case and close tightly.
Croatian: Vratite inhalator natrag u spremnik i čvrsto ga zatvorite.
English: What TOBI Podhaler looks like and contents of the pack
Croatian: Podhaler izgleda i sadržaj pakiranja
English: Inhalation powder, hard capsules Multipack: 224 capsules (4 packs of 56 + 1 inhaler) + reserve inhaler
Croatian: Prašak inhalata, tvrde kapsule Višestruko pakiranje: 224 kapsule (4 pakiranja od 56 + 1 inhalator) + rezervni inhalator
English: 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).
Croatian: 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).
English: • Pierce the capsule by pressing firmly the blue button with your thumb as far as it will go, then release the button.
Croatian: • Probušite kapsulu tako što ćete palcem čvrsto do kraja pritisnuti plavu tipku, a zatim je otpustite.
English: 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.
Croatian: 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.
English: • Replace the mouthpiece and repeat steps 8,9 and 10.
Croatian: • Vratite nastavak za usta i ponovite korake 8, 9 i 10.
English: • Hold the body of the inhaler and unscrew the mouthpiece in an anti-clockwise direction.
Croatian: • Držite tijelo inhalatora i odvijte nastavak za usta u smjeru suprotnom od smjera kazaljki na satu.
English: Four patients in the TOBI Podhaler treatment group experienced significant decreases in hearing which were transient in three patients and persistent in one case.
Croatian: Podhaler doživjela značajan gubitak sluha koji je bio prolazan u tri bolesnika, a trajan u jednog bolesnika.
English: Sulfuric acid (for pH adjustment)
Croatian: (za podešavanje pH).
English: Other medicines and TOBI Podhaler
Croatian: Drugi lijekovi i TOBI
English: For use only with the inhaler provided in the pack.
Croatian: Za uporabu samo uz inhalator priložen u pakiranju.
English: Tél: +33 1 56 64 10 70
Croatian: Mylan Medical SAS Tél: +33 1 56 64 10 70
English: Children below the age of 13 years may be more likely to cough when treated with TOBI Podhaler compared with older subjects.
Croatian: Veća je vjerojatnost da će djeca mlađa od 13 godina kašljati uslijed terapije TOBI
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari Sadržaj kapsule
English: Adverse reactions specifically associated with overdose of TOBI Podhaler have not been identified.
Croatian: Nuspojave specifično povezane s predoziranjem TOBI Podhalerom nisu utvrđene.
English: How long to take TOBI Podhaler
Croatian: Koliko dugo uzimati TOBI Podhaler
English: 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.
Croatian: 25% i 84% od predviđenih normalnih vrijednosti za svoju dob, spol i visinu na temelju Knudsonovih kriterija.