FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor may ask you to use other appropriate medicines before taking TOBI Podhaler.
Slovenian: Zdravnik vas bo morda prosil, da vzamete druga ustrezna zdravila pred uporabo zdravila TOBI Podhaler.
English: Unscrew mouthpiece (1) and remove the capsule from the chamber (2).
Slovenian: Odvijte ustnik (1) in vzemite kapsulo iz ležišča (2).
English: See also information on previous and concomitant use of systemic aminoglycosides and diuretics in section 4.4.
Slovenian: Glejte tudi podatke o predhodni in sočasni uporabi sistemskih aminoglikozidov in diuretikov v poglavju 4.4.
English: TOBI Podhaler should not be given to children less than 6 years old.
Slovenian: Zdravila TOBI Podhaler ne smejo prejemati otroci, ki so stari manj kot 6 let.
English: Do not use each inhaler and its case for longer than 1 week.
Slovenian: Posameznega inhalatorja z etuijem ne uporabljajte več kot 1 teden.
English: The Podhaler inhalation device and its storage case are made from plastic materials (polypropylene).
Slovenian: Inhalator Podhaler in njegov zaščitni etui sta izdelana iz plastičnih materialov (iz polipropilena).
English: Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Slovenian: V okviru vsakega organskega sistema so neželeni dogodki razvrščeni po pogostnosti, pri čemer so najprej navedeni najbolj pogosti učinki.
English: Haemoptysis is a complication in cystic fibrosis and is more frequent in adults.
Slovenian: Hemoptiza je zaplet pri cistični fibrozi in je bolj pogosta pri odraslih.
English: The main resistance mechanisms are drug efflux and drug inactivation by modifying enzymes.
Slovenian: Glavna mehanizma rezistence sta izločanje zdravila in inaktivacija zdravila z encimi, ki ga modificirajo.
English: 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:
Slovenian: 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:
English: Pharmacotherapeutic group: Antibacterials for systemic use, Aminoglycoside antibacterials, ATC Code: J01GB01
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje bakterijskih infekcij, aminoglikozidni antibiotiki, oznaka ATC: J01GB01
English: There are no adequate data on the use of tobramycin via inhalation in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi tobramicina z inhalacijo pri nosečnicah.
English: This analysis did not show gender or age-related pharmacokinetic differences
Slovenian: Pri tej analizi se ni pokazalo, da bi se farmakokinetične lastnosti razlikovale v odvisnosti od spola ali starosti.
English: If you are aged 65 years or older, your doctor may perform additional tests to decide if TOBI Podhaler is right for you.
Slovenian: 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.
English: Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function.
Slovenian: Aminoglikozidi lahko še dodatno poslabšajo šibkost mišic, saj lahko na živčno-mišično funkcijo delujejo podobno kot kurare.
English: Do not take the capsules out of the card in advance.
Slovenian: Kapsul ne jemljite iz tablice vnaprej.
English: • Look at the inhaler to make sure it is not damaged or dirty.
Slovenian: • Preglejte inhalator in se prepričajte, da ni poškodovan ali umazan.
English: Tobramycin is eliminated from the systemic circulation primarily by glomerular filtration of the unchanged compound.
Slovenian: Tobramicin se izloča iz sistemskega obtoka predvsem z glomerulno filtracijo nespremenjene spojine.
English: These medicines may cause muscle weakness to appear or become worse..
Slovenian: Navedena zdravila lahko povzročajo mišično šibkost ali njeno poslabšanje.
English: • 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.
Slovenian: • 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.
English: Ask your pharmacist how to dispose of medicines and inhalers no longer required.
Slovenian: Pri farmacevtu se pozanimajte, kako lahko zavržete zdravila in inhalatorje, ki jih ne potrebujete več.
English: • So for each remaining capsule, repeat steps 5,6, 7, 8, 9,
Slovenian: • Za vsako od preostalih kapsul ponovite korake št. 5, 6,
English: 10 and 11.
Slovenian: 7, 8, 9, 10 in 11.
English: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Slovenian: 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).
English: Always store inhaler in its case.
Slovenian: Inhalator vedno shranjujte v njegovem etuiju.
English: Remove the inhaler from your mouth, and hold your breath for about 5 seconds.
Slovenian: Inhalator odmaknite od ust in približno 5 sekund zadržujte dih.
English: Based on available data from animals a risk of toxicity (e.g. ototoxicity) at prenatal exposure levels cannot be excluded.
Slovenian: 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.
English: • Other medicines which may harm your kidneys or hearing.
Slovenian: • drugih zdravil, ki lahko škodujejo ledvicam ali sluhu.
English: Inhale the powder deeply with a single breath.
Slovenian: Z enim vdihom globoko inhalirajte prašek.
English: • The active substance is tobramycin.
Slovenian: • Učinkovina je tobramicin.
English: Briefly inspect the inhaler to make sure it is not damaged or dirty.
Slovenian: Na hitro preglejte inhalator in se prepričajte, da ni poškodovan ali umazan.
English: Lift here to open.
Slovenian: Odprite tu.
English: 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.
Slovenian: 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.
English: Clinical experience
Slovenian: KLINIČNI PODATKI
English: 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.
Slovenian: Če ste pozabili vzeti zdravilo TOBI Podhaler in je do naslednjega odmerka več kot 6 ur, vzemite odmerek takoj, ko ga lahko.
English: Severely maternally toxic doses to female rabbits (i.e. nephrotoxicity) lead to spontaneous abortions and death.
Slovenian: Odmerki, ki so delovali zelo toksično na samice kuncev (in sicer nefrotoksično), so povzročili spontane splave in smrt pri zarodkih.
English: Hypersensitivity to the active substance and any aminoglycoside, or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino in katerikoli aminoglikozid ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: For safety results see section 4.8
Slovenian: Za rezultate glede varnosti zdravila glejte poglavje 4.8.
English: • Anticholinesterases such as neostigmine and pyridostigmine (used to treat muscle weakness), or botulinum toxin.
Slovenian: • antiholinesteraze, kot sta neostigmin in piridostigmin (za zdravljenje mišične šibkosti), ali botulinski toksin.
English: 56 capsules and 1 inhaler
Slovenian: 56 kapsul in 1 inhalator
English: If you have questions about how long to take TOBI Podhaler for, talk to your doctor or your pharmacist.
Slovenian: Če imate vprašanja glede tega, kako dolgo jemati zdravilo TOBI Podhaler, se obrnite na zdravnika ali farmacevta.
English: Inspect the used capsule.
Slovenian: Preglejte uporabljeno kapsulo.
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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: After this if the capsule is still full and appears to be unpunctured, replace the inhaler with the reserve inhaler and try again.
Slovenian: Če je kapsula po tem poskusu še vedno polna in ni videti predrta, zamenjajte inhalator z rezervnim in poskusite znova.
English: Serum concentrations greater than 12 µg/ml are associated with tobramycin toxicity and treatment should be discontinued if concentrations exceed this level.
Slovenian: Pri koncentracijah, ki presegajo 12 µg/ml, prihaja do toksičnega delovanja tobramicina, zato je treba zdravljenje prekiniti, če koncentracija presega to vrednost.
English: It is a very common bacterium that infects the lungs of nearly everyone with cystic fibrosis at some time during their lives.
Slovenian: To je zelo pogosta bakterija, ki pri skoraj vsakem posamezniku s cistično fibrozo prej ali slej v življenju povzroči okužbo pljuč.
English: Inhale the content of 4 capsules twice a day (4 capsules in the morning and 4 capsules in the evening), using the Podhaler device.
Slovenian: Inhalirajte vsebino 4 kapsul dvakrat na dan (4 kapsule zjutraj in 4 kapsule zvečer), in sicer s pomočjo inhalatorja Podhaler.
English: After a few normal breaths away from the inhaler, perform a second inhalation from the same capsule.
Slovenian: Po nekaj normalnih vdihih in izdihih stran od inhalatorja izvedite še drugi vdih iz iste kapsule.
English: 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.
Slovenian: 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.
English: • Platinum compounds such as carboplatin and cisplatin (used to treat some forms of cancer).
Slovenian: • zdravila, ki vsebujejo platino, kot sta karboplatin in cisplatin (za zdravljenje nekaterih vrst raka).
English: In case of missed dose with at least 6 hours until the next dose, the patient should take the dose as soon as possible.
Slovenian: Če bolnik izpusti odmerek in je do naslednjega odmerka še najmanj 6 ur, naj bolnik vzame odmerek čimprej.
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%.
Slovenian: 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.
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).
Slovenian: 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).
English: • Store in the original packaging in order to protect from moisture.
Slovenian: • Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
English: In the active-controlled study, at least 89% of patients had P. aeruginosa isolates with MICs at least 15 times lower than mean post-dose sputum concentration, both at baseline and at the end of the third active treatment cycle.
Slovenian: V aktivno kontrolirani študiji je imelo najmanj 89 % bolnikov izolate bakterije P. aeruginosa z MIK, ki je bila vsaj 15-krat nižja od povprečne koncentracije zdravila v slini po odmerjanju, in sicer tako ob izhodišču kot ob koncu tretjega aktivnega ciklusa zdravljenja.
English: 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).
Slovenian: Druga zdravila, o katerih so poročali, da povečujejo potencialno toksičnost parenteralno apliciranih aminoglikozidov, vključujejo: - amfotericin B, cefalotin, ciklosporin, takrolimus, polimiksine (tveganje za povečano nefrotoksičnost); - sredstva, ki vsebujejo platino (tveganje za povečano nefrotoksičnost in ototoksičnost);
English: • Do not press the piercing button more than once at a time.
Slovenian: • Gumba za prediranje kapsule ne pritiskajte več kot enkrat zaporedno.
English: Because of the potential for ototoxicity and nephrotoxicity in infants, a decision should be made whether to terminate breast-feeding or discontinue treatment with TOBI Podhaler, taking into account the importance of the treatment to the mother.
Slovenian: Zaradi možnosti ototoksičnega in nefrotoksičnega delovanja na otroka se je treba odločiti med prenehanjem dojenja in prekinitvijo zdravljenja z zdravilom TOBI Podhaler, pri čemer je treba upoštevati, kako pomembno je zdravljenje za mater.
English: In clinical studies, patients receiving TOBI Podhaler continued to take dornase alfa, bronchodilators, inhaled corticosteroids and macrolides, no evidence of drug interactions with these medicines was identified.
Slovenian: V kliničnih študijah so bolniki, ki so prejemali zdravilo TOBI Podhaler, še naprej uporabljali dornazo alfa, bronhodilatatorje, inhalacijske kortikosteroide in makrolide, pri tem pa niso ugotovili nobenih znakov medsebojnega delovanja z navedenimi zdravili.
English: The improvements in lung function achieved during the first treatment cycle were maintained during the two subsequent cycles of treatment with TOBI Podhaler.
Slovenian: Izboljšanje pljučne funkcije, do katerega je prišlo v času prvega ciklusa zdravljenja, se je ohranilo tudi v naslednjih dveh ciklusih zdravljenja z zdravilom TOBI Podhaler.
English: Remove inhaler from mouth, and hold breath for approximately 5 seconds, then exhale normally away from the inhaler.
Slovenian: Inhalator odmaknite od ust in zadržujte dih približno 5 sekund, nato pa normalno izdihnite v smeri stran od inhalatorja.
English: Patients with serum creatinine 2 mg/dl or more and blood urea nitrogen (BUN) 40 mg/dl or more have not been included in clinical studies and there are no data in this population to support a recommendation for or against dose adjustment with TOBI Podhaler.
Slovenian: Bolnikov, ki so imeli koncentracijo kreatinina v serumu 2 mg/dl ali več in koncentracijo dušika sečnine v krvi 40 mg/dl ali več, niso vključevali v klinične študije, zato pri tej skupini bolnikov ni podatkov, na podlagi katerih bi lahko priporočali ali odsvetovali prilagajanje odmerkov zdravila TOBI Podhaler.
English: No other inhaler may be used.
Slovenian: Drugega inhalatorja ni dovoljeno uporabljati.
English: The two doses (of 4 capsules each) should be inhaled as close as possible to 12 hours apart and not less than 6 hours apart.
Slovenian: Dva odmerka dnevno (vsakokrat po 4 kapsule) je treba inhalirati v časovnem razmiku, ki je kar najbližje 12 uram in ni krajši od 6 ur.
English: Immediately insert the capsule into the inhaler chamber.
Slovenian: Kapsulo takoj vstavite v ležišče na inhalatorju.
English: TOBI Podhaler has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo TOBI Podhaler nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: 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.
Slovenian: Po jemanju zdravila TOBI Podhaler 28 dni je na vrsti 28-dnevni odmor, v katerem ne inhalirate zdravila TOBI Podhaler.
English: For the best results from this medicine, please use it as this leaflet instructs you.
Slovenian: Da bi dosegli kar najboljše rezultate zdravljenja, uporabljajte zdravilo v skladu z Navodilom za uporabo.
English: Although the magnitude of improvements in lung function was smaller in this study, this is explained by the previous exposure of this patient population to treatment with inhaled tobramycin.
Slovenian: Obseg izboljšanja pljučne funkcije je bil v tej študiji manjši, kar je mogoče pojasniti z dejstvom, da so bili bolniki v tej študiji že predhodno izpostavljeni inhalacijskemu tobramicinu.
English: Please read the following instructions carefully to learn how to use and care for your Podhaler device.
Slovenian: Skrbno preberite naslednja navodila, da boste znali uporabljati inhalator Podhaler in skrbeti zanj.
English: The European Medicines Agency has waived the obligation to submit the results of studies with TOBI Podhaler in one or more subsets of the paediatric population in treatment of pseudomonas aeruginosa pulmonary infection/colonisation in patients with cystic fibrosis (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom TOBI Podhaler za vse podskupine pediatrične populacije pri zdravljenju okužbe pljuč/kolonizacije z bakterijo Pseudomonas aeruginosa pri bolnikih s cistično fibrozo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: • Each capsule card contains 8 capsules (corresponding to a daily dose: content of 4 capsules to be inhaled in the morning and content of 4 capsules to be inhaled in the evening).
Slovenian: • ena tablica s kapsulami vsebuje 8 kapsul (kar ustreza dnevnemu odmerku: vsebino 4 kapsul je treba inhalirati zjutraj, vsebino drugih 4 kapsul pa zvečer).
English: Resistance to tobramycin involves different mechanisms.
Slovenian: Pri rezistenci na tobramicin sodelujejo različni mehanizmi.
English: The serum concentration of tobramycin should only be monitored through validated methods.
Slovenian: Koncentracijo tobramicina v serumu je treba meriti samo z validiranimi (preizkušenimi) metodami.
English: See also section 4.2 and “Monitoring of serum tobramycin concentrations” below.
Slovenian: Glejte tudi poglavje 4.2 in "Spremljanje koncentracij tobramicina v serumu" v nadaljevanju.
English: Each TOBI Podhaler capsule should be inhaled with two breath-hold manoeuvres and checked to ensure it is empty.
Slovenian: Eno kapsulo zdravila TOBI Podhaler je treba inhalirati z dvema postopkoma zadrževanja diha in nato preveriti, ali je kapsula res prazna.
English: Adverse drug reactions in Table 1 are listed according to system organ classes in MedDRA.
Slovenian: V preglednici 1 so neželeni učinki zdravila navedeni po organskih sistemih klasifikacije MedDRA.
English: Each inhaler is only used for 7 days.
Slovenian: En inhalator lahko uporabljate le 7 dni.
English: Do not use TOBI Podhaler capsules with any other device, and do not use the Podhaler device to take any other medicine.
Slovenian: TOBI Podhaler ne uporabljajte z nobenim drugim inhalatorjem, inhalatorja Podhaler pa ne uporabljate za jemanje nobenega drugega zdravila.
English: It must not be administered by any other route or using any other inhaler.
Slovenian: Zdravila se ne sme aplicirati na noben drug način in z nobenim drugim inhalatorjem.
English: Suppression of sputum P. aeruginosa density was similar across age groups in both arms.
Slovenian: Zmanjševanje gostote bakterij P. aeruginosa v izpljunku je bilo podobno v vseh starostnih skupinah v obeh krakih.
English: The inhaler should never be washed with water.
Slovenian: Inhalatorja nikoli ne smete umivati z vodo.
English: In case of signs of acute toxicity, immediate withdrawal of TOBI Podhaler and testing of renal function are recommended.
Slovenian: V primeru znakov akutnega toksičnega delovanja sta priporočena takojšnja prekinitev zdravljenja z zdravilom TOBI Podhaler in izvajanje preiskav ledvične funkcije.
English: In general, toxicity is seen at higher systemic tobramycin levels than are achievable by inhalation at the recommended clinical dose.
Slovenian: Večinoma so toksično delovanje opažali pri sistemskih koncentracija tobramicina, ki so bile višje od tistih, ki jih je mogoče doseči pri inhalaciji priporočenih kliničnih odmerkov.
English: TOBI Podhaler is administered by inhalation using the Podhaler device (see section 6.6 for detailed instructions for use).
Slovenian: Zdravilo TOBI Podhaler je treba aplicirati z inhaliranjem s pomočjo inhalatorja Podhaler (za podrobna navodila za uporabo glejte poglavje 6.6).
English: Each weekly carton of TOBI Podhaler contains:
Slovenian: Ena škatla za tedensko pakiranje zdravila TOBI Podhaler vsebuje:
English: How to inhale your medicine with the Podhaler device • Only use Podhaler device contained in this pack.
Slovenian: Kako inhalirati zdravilo z inhalatorjem Podhaler • Uporabljajte samo inhalator Podhaler, ki je priložen v tem pakiranju.
English: It is important that you keep using the product twice each day during your 28 days on treatment and that you keep to the 28-day on, 28-day off cycle.
Slovenian: Pomembno je, da v 28-dnevnem obdobju uporabe zdravila jemljete zdravilo dvakrat na dan in da se držite sheme 28 dni uporabe zdravila, ki ji sledi 28 dni odmora, ko zdravila ne uporabljate.
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.
Slovenian: V skupini z zdravilom TOBI Podhaler je pri štirih bolnikih prišlo do pomembnega poslabšanja sluha, ki je bilo pri treh bolnikih prehodno, v enem primeru pa trajno.
English: In children under 13 years of age, discontinuations were more frequent in the TOBI nebuliser solution arm whereas in patients aged 13 to 19, discontinuation rates with both formulations were similar.
Slovenian: Pri otrocih, ki so bili stari manj kot 13 let, je do prekinitve zdravljenja prišlo pogosteje v skupini z uporabo raztopine za nebulator TOBI, medtem ko je pri bolnikih, ki so bili stari od 13 do 19 let, prihajalo do prekinitev enako pogosto pri obeh oblikah zdravila.
English: TOBI Podhaler is a powder for inhalation that is filled into capsules.
Slovenian: Zdravilo TOBI Podhaler je prašek za inhaliranje, polnjen v kapsule.
English: The vast majority of adverse reactions reported with TOBI Podhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods.
Slovenian: V veliki večini so bili neželeni učinki, o katerih so poročali pri uporabi zdravila TOBI Podhaler, blago ali zmerno izraženi, pri čemer ni kazalo, da bi se izraženost razlikovala med posameznimi ciklusi oziroma med obdobjem celotne študije in obdobji jemanja zdravila.
English: A difference in FEV1 response by age was noted.
Slovenian: Opažali so, da se odziv FEV1 razlikuje glede na starost bolnikov.
English: These medicines may harm the kidneys.
Slovenian: Navedena zdravila lahko škodujejo ledvicam.