FrancophonIA/ELRC3.0 huggingface dataset:
English: One glass vial containing Cayston is opened by carefully removing the blue cap and the metal ring, and then the grey rubber stopper.
Croatian: Jedna staklena bočica koja sadrži Cayston otvara se tako da se najprije pažljivo uklone plava kapica i metalni prsten, a potom sivi gumeni čep.
English: Cayston contains the active substance aztreonam.
Croatian: Cayston sadrži djelatnu tvar aztreonam.
English: If not used immediately, the prepared solution must be stored at 2°C - 8°C and used within 8 hours.
Croatian: Ako se ne primijeni odmah, pripravljena otopina mora se čuvati na temperaturi između 2°C - 8°C i primijeniti u roku od 8 sati.
English: Pharmacokinetic properties for aztreonam for injection
Croatian: Farmakokinetička svojstva aztreonama za injekciju
English: Cayston was evaluated over a period of 28-days of treatment (one course) in two randomised, doubleblind, placebo-controlled, multicentre studies (CP-AI-005 and CP-AI-007).
Croatian: Liječenje Caystonom u trajanju od 28 dana (jedna kura) procijenilo se u dvama randomiziranim, dvostruko slijepim, multicentričnim, placebom kontroliranim ispitivanjima (CP-AI-005 i CP-AI-007).
English: Read the manufacturer's instructions for use provided with your Altera Nebuliser System carefully.
Croatian: Pažljivo pročitajte proizvođačeve upute za upotrebu koje ste dobili uz sustav za atomiziranje Altera.
English: The unopened vials may also be stored outside the refrigerator but below 25°C for up to 28 days.
Croatian: Neotvorene bočice mogu se čuvati i izvan hladnjaka, ali na temperaturi ispod 25°C do 28 dana.
English: Cystic fibrosis, also known as mucoviscidosis, is a life-threatening inherited disease that affects the mucus glands of internal organs, especially the lungs, but also of the liver, pancreas, and the digestive system.
Croatian: Cistična fibroza, poznata i pod nazivom mukoviscidoza, po život je opasna nasljedna bolest koja zahvaća sluzne žlijezde unutarnjih organa, osobito pluća, ali i jetre, gušterače i probavnog sustava.
English: During clinical studies of Cayston, isolation of MRSA did not result in worsening of lung function.
Croatian: Tijekom kliničkih ispitivanja Caystona, izolacija MRSA-e nije uzrokovala pogoršanje plućne funkcije.
English: For inhalation use.
Croatian: Za primjenu inhalacijom.
English: The Kaplan-Meier estimates for this event rate at week 24 were 36% in aztreonamtreated patients and 54% in TNS-treated patients.
Croatian: Kaplan-Meierove procjene za stopu ovih događaja u 24. tjednu iznosile su 36% kod bolesnika liječenih aztreonamom te 54% kod bolesnika liječenih TNS-om.
English: Approximately 10% of the total inhaled aztreonamdose is excreted in the urine as unchanged drug, as compared to 60-65% following intravenous administration of aztreonam for injection.
Croatian: Približno 10% ukupne doze inhaliranog aztreonama izlučuje se u urinu kao nepromijenjeni lijek u usporedbi s 60 do 65% nakon intravenske primjene aztreonama za injekciju.
English: Resistance to aztreonam, other antibiotics and treatment-emergent microorganisms
Croatian: Rezistencija na aztreonam, druge antibiotike i mikroorganizmi prouzročeni liječenjem
English: Animal and human data demonstrate low risk of cross-reactivity between aztreonam and beta-lactam antibiotics.
Croatian: Podaci dobiveni ispitivanjima na životinjama i ljudima pokazuju mali rizik od križne reaktivnosti između aztreonama i beta-laktamskih antibiotika.
English: However, decreased P. aeruginosa susceptibility was not predictive of clinical efficacy of Cayston during the study.
Croatian: No, smanjena osjetljivost P. aeruginosa nije bila prediktivna za kliničku djelotvornost Caystona tijekom kliničkog ispitivanja.
English: Class A betalactamases reported to hydrolyse aztreonam include the VEB type (primarily Southeast Asia), PER type (Turkey), and GES and IBC types (France, Greece, and S. Africa).
Croatian: Beta-laktamaze klase A za koje je zabilježeno da hidroliziraju aztreonam obuhvaćaju vrstu VEB (prvenstveno u Jugoistočnoj Aziji), vrstu PER (u Turskoj) te vrste GES i IBC (u Francuskoj, Grčkoj i Južnoj Africi).
English: To re-start the treatment, press and hold the On/Off button for one full second and then restart the treatment.
Croatian: Da biste nastavili s liječenjem, pritisnite i držite tipku za uključivanje/isključivanje jednu punu sekundu, a zatim nastavite s liječenjem.
English: But, if you cannot use the prepared dose straight away, replace the stopper in the vial and store in a refrigerator.
Croatian: No ako pripravljenu dozu ne možete primijeniti odmah, čepom ponovno zatvorite bočicu i spremite je u hladnjak.
English: Aztreonam is known to be excreted renally and therefore administration of Cayston in patients with renal impairment (serum creatinine > 2 times upper limit of normal) should be undertaken with caution.
Croatian: Poznato je da se aztreonam izlučuje putem bubrega, pa Cayston bolesnicima s oštećenom funkcijom bubrega (kreatinin u serumu > 2 puta iznad gornje granice normale) treba primjenjivati s oprezom.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Croatian: Za upute o rekonstituciji lijeka prije primjene vidjeti dio 6.6.
English: Gently tap the amber vial containing the Cayston so that the powder settles at the bottom.
Croatian: Lagano kucnite smeđu bočicu koja sadrži Cayston tako da se prašak slegne na dno.
English: Press down and turn the cap clockwise as far as it will go (Figure 3b).
Croatian: Pritisnite čep i zakrenite ga u smjeru kazaljke na satu koliko god je to moguće (Slika 3b).
English: Patients with Burkholderia cepacia isolated from sputum within the previous 2 years were excluded from the clinical studies.
Croatian: Bolesnici u kojih je u iskašljaju tijekom prethodne 2 godine izolirana Burkholderia cepacia bili su isključeni iz kliničkih ispitivanja.
English: Following reconstitution, Cayston is a clear, colourless to slightly coloured solution.
Croatian: Nakon rekonstitucije Cayston je bistra, bezbojna do blago obojena otopina.
English: If not used immediately, the reconstituted solution must be stored at 2°C - 8°C and used within 8 hours.
Croatian: Ako se ne primijeni odmah, rekonstituirana otopina mora se čuvati na temperaturi između 2°C - 8°C i primijeniti u roku od 8 sati.
English: Do not use this medicine if it has been stored outside a refrigerator for more than 28 days.
Croatian: Ovaj lijek se ne smije upotrijebiti ako se dulje od 28 dana čuvao izvan hladnjaka.
English: Make sure the Altera Nebuliser Handset is on a flat, stable surface.
Croatian: Provjerite je li ručni atomizator Altera na ravnoj, stabilnoj podlozi.
English: Open the ampoule of solvent by twisting off the tip.
Croatian: Otvorite ampulu s otapalom tako što ćete odvrnuti vrh.
English: An association between persistent isolation of MRSA and more severe disease and increased mortality has been reported in the literature.
Croatian: Povezanost između trajne izolacije MRSA i ozbiljnijih bolesti te povećane smrtnosti zabilježena je u literaturi.
English: In the limited subgroup of patients who received inhaled tobramycin for less than 84 days in the previous 12 months (n = 40), lung function improvements at Day 28 and across three 28-day treatment courses were numerically smaller among aztreonam-treated patients than TNS-treated patients.
Croatian: U ograničenim podskupinama bolesnika koji su primali inhalirani tobramicin tijekom manje od 84 dana u prethodnih 12 mjeseci (n = 40), poboljšanja plućne funkcije u 28. danu te tijekom tri 28dnevne kure liječenja bila su brojčano manja kod bolesnika liječenih aztreonamom nego kod bolesnika liječenih TNS-om.
English: Talk to your doctor before taking Cayston: - if you are allergic to any other antibiotics (such as penicillins, cephalosporins, and/or carbapenems) - if you do not tolerate or have chest tightness from taking other inhaled medicines
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Cayston: - ako ste alergični na bilo koje druge antibiotike (primjerice peniciline, cefalosporine i/ili karbapeneme) - ako ne podnosite ili osjećate stezanje u prsištu kod uzimanja drugih lijekova za udisanje - ako imate tegobe s bubrezima - ako ste ikada iskašljavali krv - ako ste ikada imali loše rezultate testiranja plućne funkcije
English: Lung function test decreased has been reported with use of Cayston, but was not associated with a sustained decrease in FEV1 (see section 5.1).
Croatian: Smanjenje rezultata testiranja funkcije pluća zabilježeno je s primjenom Caystona, ali nije povezano s održanim padom FEV1 (vidjeti dio 5.1).
English: Step B: Pull the blue cap down to a flat (horizontal) position (where the bottom of the blue cap faces up), to prepare the metal seal for removal.
Croatian: Korak B: Odignite plavu kapicu i pogurajte je do vodoravnog (horizontalnog) položaja (da joj donja strana bude okrenuta prema gore), kako bi je namjestili za uklanjanje metalnog prstena.
English: Patients participating in these studies could subsequently receive multiple courses of Cayston in an open-label follow-on study (CP-AI-006).
Croatian: Bolesnici koji su sudjelovali u tim ispitivanjima naknadno su mogli primiti više kura Caystona u otvorenom ispitivanju nastavka liječenja (follow-on ispitivanje CP-AI-006).
English: Therefore, and because of low oral absorption, aztreonam exposure in breast-fed infants due to mothers receiving Cayston is likely to be extremely low.
Croatian: Zbog toga, kao i zbog niske peroralne apsorpcije, izloženost dojenčadi aztreonamu do koje dolazi jer im majke primaju Cayston vjerojatno je iznimno mala.
English: The adverse reactions considered at least possibly related to treatment from clinical study and postmarketing experience are listed below by body system organ class and frequency.
Croatian: Nuspojave koje se smatraju barem moguće povezanima s liječenjem u kliničkim ispitivanjima i nakon stavljanja lijeka u promet navedene su u nastavku prema klasifikaciji organskih sustava i učestalosti.
English: Nebulised therapies, including Cayston, may be associated with bronchospasm (an acute reduction of ≥ 15% in FEV1).
Croatian: Terapije koje se primjenjuju atomizatorom, uključujući Cayston, mogu biti povezane s bronhospazmom (akutnim smanjenjem FEV1 za ≥ 15%).
English: This pack contains one Altera Nebuliser Handset.
Croatian: Ovo pakiranje sadrži jedan ručni atomizator Altera.
English: A few drops of medicine may remain in the reservoir at the end of treatment.
Croatian: Na kraju liječenja u spremniku može ostati nekoliko kapi lijeka.
English: In GS-US-205-0110, 268 patients with CF and chronic P. aeruginosa lung infection were randomised and received Cayston (n = 136) or TNS (n = 132).
Croatian: U ispitivanju GS-US-205-0110, 268 bolesnika s CF-om i kroničnom infekcijom pluća s P. aeruginosa bili su randomizirani te su primali Cayston (n = 136) ili TNS (n = 132).
English: Patients participating in this study in Europe who completed at least 1 course of Cayston or TNS during the randomised phase could subsequently receive up to three 28-day courses of Cayston in an open-label extension phase.
Croatian: Bolesnici koji su sudjelovali u ovom ispitivanju u Europi, a koji su dovršili najmanje jednu kuru Caystona ili TNS-a tijekom randomizirane faze imali su mogućnost naknadnog primanja tri 28-dnevne kure Caystona u otvorenoj fazi nastavka liječenja.
English: The occurrence of rash may be indicative of an allergic reaction to aztreonam.
Croatian: Pojava osipa može upućivati na alergijsku reakciju na aztreonam.
English: GILEAD SCIENCES
Croatian: DRUGO GILEAD SCIENCES
English: Do not reconstitute more than one dose at a time.
Croatian: Nemojte rekonstituirati više doza odjednom.
English: For complete details on cleaning and disinfecting refer to the manufacturer's instructions for use provided with your Altera Nebuliser Handset.
Croatian: Podrobne pojedinosti o čišćenju i dezinficiranju potražite u proizvođačevim uputama za upotrebu koje ste dobili uz ručni atomizator Altera.
English: For storage conditions of the reconstitued medicinal product, see section 6.3.
Croatian: Uvjete čuvanja rekonstituiranog lijeka vidjeti u dijelu 6.3.
English: Assessment of adverse reactions is based on experience in four Phase 3 clinical studies involving CF patients with chronic P. aeruginosa infection and post-marketing spontaneous reporting.
Croatian: Procjena nuspojava temelji se na iskustvu iz četiri klinička ispitivanja faze 3 koja su uključivala CF bolesnike s kroničnom infekcijom P. aeruginosa i spontane prijave nakon stavljanja lijeka u promet.
English: In studies of up to nine 28-day courses of Cayston therapy, no increases of clinical significance were observed in the treatment-emergent isolation of other gram-negative bacterial respiratory pathogens (Burkholderia species, Stenotrophomonas maltophilia and Alcaligenes species).
Croatian: Tijekom ispitivanja terapije Caystonom primijenjene u najviše devet 28-dnevnih kura nisu primijećena nikakva klinički značajna povećanja izolacije drugih gram negativnih respiratornih patogenih bakterija (vrste Burkholderia, Stenotrophomonas maltophilia te vrste Alcaligenes) prouzročena liječenjem.
English: Inhalation of nebulised solutions may induce a cough reflex which could aggravate underlying conditions (see section 4.4).
Croatian: Udisanje atomizirane otopine može potaknuti refleks kašlja koji može pogoršati osnovnu bolest (vidjeti dio 4.4).
English: Loss of susceptibility to aztreonam in CF patients with P. aeruginosa occurs either through selection of strains with mutations located on the chromosome or rarely through acquisition of plasmid/integron mediated genes.
Croatian: Gubitak osjetljivosti P. aeruginosa na aztreonam u bolesnika s CF-om događa se ili putem odabira sojeva s mutacijama lociranim na kromosomu ili, rijetko, preuzimanjem gena posredovanjem plazmida/integrona.
English: Adverse reactions specifically associated with overdose of Cayston have not been identified.
Croatian: Nuspojave specifično povezane s predoziranjem Caystonom nisu utvrđene.
English: Aztreonam is not extensively metabolised.
Croatian: Aztreonam ne podliježe opsežnom metabolizmu.
English: Aztreonam binds to penicillin-binding proteins of susceptible bacteria, which leads to inhibition of bacterial cell wall synthesis, followed by filamentation and cell lysis.
Croatian: Aztreonam se veže za proteine osjetljivih bakterija koje vežu penicilin, što dovodi do inhibicije sinteze bakterijske stanične stijenke , a zatim i do filamentacije i lize stanice.
English: Very common side effects (affects more than 1 user in 10) - Cough - Blocked nose - Wheezing - Sore throat - Shortness of breath - High temperature.
Croatian: Vrlo česte nuspojave (javljaju se u više od 1 korisnika na 10) - kašalj začepljen nos - piskanje pri disanju - grlobolja - nedostatak zraka - povišena temperatura.
English: Preparing the Altera Nebuliser to take your Cayston 1.
Croatian: Priprema atomizatora Altera za uzimanje Caystona 1.
English: Take one amber vial of Cayston and one ampoule of solvent from the box.
Croatian: Uzmite jednu smeđu bočicu Caystona i jednu ampulu s otapalom iz kutije.
English: Cayston can be used during breast-feeding.
Croatian: Cayston se može primjenjivati tijekom dojenja.
English: Bronchospasm (an acute reduction of ≥ 15% in FEV1) is a complication associated with nebulised therapies.
Croatian: Bronhospazam (akutno smanjenje FEV1 za ≥ 15%) je komplikacija povezana s terapijom koja se primjenjuje atomizatorom.
English: Cayston should not be reconstituted until a dose is ready to be administered.
Croatian: Cayston se ne smije rekonstituirati dok doza nije spremna za primjenu.
English: An increased prevalence of methicillin-resistant Staphylococcus aureus (MRSA), methicillin-sensitive S. aureus (MSSA), Aspergillus and Candida species was observed over time in patients treated with several Cayston treatment courses.
Croatian: Povećana prevalencija Staphylococcus aureus rezistentnog na meticilin (MRSA), na meticilin osjetljivog S. aureus (MSSA) te vrste Aspergillus i Candida primijećene su tijekom vremena u bolesnika liječenih s nekoliko kura Caystona.
English: A single sputum sample from a CF patient may contain multiple isolates of P. aeruginosa and each isolate may have a different level of in vitro susceptibility to aztreonam.
Croatian: Jedan uzorak iskašljaja bolesnika s CF-om može sadržavati više izolata P. aeruginosa, a svaki od njih može imati različitu razinu osjetljivosti na aztreonam in vitro.
English: Entry criteria included CF, FEV1 ≤ 75% predicted, stable pulmonary disease, a recent positive sputum culture for P. aeruginosa, and previous treatment with aerosolised antibiotics without demonstration of drug intolerance.
Croatian: Kriteriji pristupanja uključivali su CF, FEV1 ≤ 75% predviđenog, stabilnu plućnu bolest, pozitivnu kulturu iskašljaja na P. aeruginosa u nedavnom testiranju te prethodno liječenje s aerosoliziranim antibioticima bez dokaza nepodnošenja lijeka.
English: In a Phase 2 open-label study (GS-US-205-0162), 105 paediatric patients aged 3 months to < 18 years (24 patients aged 3 months to < 2 years; 25 patients aged 2 to < 6 years; 56 patients aged 6 to < 18 years) with CF and documented initial/new onset P. aeruginosa infection/colonisation received Cayston 3 times a day for a single course of 28 days.
Croatian: U otvorenom ispitivanju faze 2 (GS-US-205-0162), 105 pedijatrijskih bolesnika u dobi od 3 mjeseca do < 18 godina (24 bolesnika u dobi od 3 mjeseca do < 2 godine; 25 bolesnika u dobi od 2 do < 6 godina; 56 bolesnika u dobi od 6 do < 18 godina) s CF i dokumentiranom početnom/novonastalom infekcijom/kolonizacijom P. aeruginosa primalo je Cayston 3 puta na dan tijekom jedne kure od
English: Cayston should not be used with any other type of handset or aerosol head.
Croatian: Cayston se ne smije primjenjivati ni s kojom drugom ručnom napravom ili glavom za aerosol.
English: Next, gently swirl the vial until the powder has completely dissolved and the liquid is clear.
Croatian: Zatim lagano okrećite bočicu dok se prašak u potpunosti ne otopi i dok tekućina ne postane bistra.
English: Common side effects (affects 1 to 10 users in 100) - Difficulty breathing - Chest discomfort - Runny nose - Coughing up blood - Rash
Croatian: Česte nuspojave (javljaju se u od 1 do 10 korisnika na 100) - otežano disanje - nelagodan osjećaj u prsnom košu - curenje iz nosa - iskašljavanje krvi
English: An acute reduction of ≥ 15% in FEV1 is a complication associated with nebulised therapies, including Cayston (see section 4.4).
Croatian: Akutno smanjenje FEV1 za ≥ 15% komplikacija je povezana s terapijama koje se primjenjuju atomizatorom, uključujući Cayston (vidjeti dio 4.4).
English: - The solvent ampoule contains water for injections and sodium chloride.
Croatian: - Ampula s otapalom sadrži vodu za injekcije i natrijev klorid.
English: There was no clinically relevant effect of age or sex on the pharmacokinetics of aztreonam.
Croatian: Dob i spol nemaju nikakav klinički važan utjecaj na farmakokinetička svojstva aztreonama.
English: Aztreonam-treated patients also demonstrated larger mean improvements in CFQ-R respiratory symptoms scores compared to TNS-treated patients across 3 treatment courses (6.30 versus 2.17, p = 0.019).
Croatian: Bolesnici liječeni aztreonamom također su iskazali veća prosječna poboljšanja u rezultatima CFQ-R dišnih simptoma u usporedbi s bolesnicima liječenim TNS-om tijekom 3 kure liječenja (6,30 nasuprot 2,17, p = 0,019).
English: After this time replace your Altera Nebuliser Handset, including the aerosol head.
Croatian: Nakon toga zamijenite ručni atomizator Altera, uključujući glavu za aerosol.
English: Administration of Cayston in CF patients with active haemoptysis should be undertaken only if the benefits of treatment are considered to outweigh the risks of inducing further haemorrhage.
Croatian: Cayston u CF bolesnika s aktivnom hemoptizom smije se primijeniti samo ako se smatra da koristi liječenja nadmašuju rizike od poticanja daljnjeg krvarenja.
English: Development of resistance during inhaled aztreonam therapy could limit treatment options during acute exacerbations.
Croatian: Razvoj rezistencije tijekom terapije inhaliranim aztreonamom može ograničiti mogućnosti liječenja tijekom akutnih egzacerbacija.
English: An association between persistent isolation of MRSA and worse clinical outcome has been reported in the literature.
Croatian: Povezanost između ustrajne izolacije MRSA-e i lošijeg kliničkog ishoda zabilježena je u literaturi.
English: Powder vial and solvent ampoule: Store in a refrigerator (2°C - 8°C).
Croatian: Bočica s praškom i ampula s otapalom: Čuvati u hladnjaku (2°C - 8°C).
English: If you stop taking Cayston
Croatian: Ako prestanete uzimati Cayston
English: If aerosol mist does not begin to flow, please refer to the Altera manual for information.
Croatian: Ako aerosolna para ne počne teći, dodatne informacije potražite u Alterinu priručniku.
English: If you forget to take Cayston
Croatian: Ako ste zaboravili uzeti Cayston
English: In the two Phase 3 placebo-controlled clinical studies where patients received Cayston for 28 days, the most frequently occurring adverse reactions to Cayston were cough (58%), nasal congestion (18%), wheezing (15%), pharyngolaryngeal pain (13.0%), pyrexia (12%) and dyspnoea (10%).
Croatian: U dvama placebom kontroliranim ispitivanjima faze 3 u kojima su bolesnici tijekom 28 dana primali Cayston najčešće nuspojave Caystona bile su kašalj (58%), kongestija nosa (18%), piskanje pri disanju (15%), bol u ždrijelu i grkljanu (13,0%), pireksija (12%) i dispneja (10%).
English: Treatment-emergent persistent isolation (defined as absent at screening/baseline then present at 3 or more subsequent consecutive visits) of MSSA occurred in 6% of aztreonam-treated patients compared to 3% of TNS-treated patients.
Croatian: Trajne izolacije prouzročene liječenjem (definirane kao odsutne prilikom probira/na početku, a potom prisutne u 3 ili više uzastopnih posjeta nakon toga) MSSA-e pojavile su se u 6% bolesnika liječenih aztreonamom u usporedbi s 3% bolesnika liječenih TNS-om.
English: During the 6-month randomised phase of study GS-US-205-0110, treatment-emergent isolation of MSSA and MRSA was observed more commonly among aztreonam-treated patients than Tobramycin Nebuliser Solution (TNS)-treated patients.
Croatian: Tijekom 6-mjesečne randomizirane faze ispitivanja GS-US-205-0110, izolacija MSSA-e i MRSA-e prouzročenih liječenjem, primijećena je više kod bolesnika liječenih aztreonamom nego s otopinom tobramicina za atomizator (TNS-om, Tobramycin Nebuliser Solution).
English: Following administration of aztreonam for injection, aztreonam is excreted in human milk at very low concentrations.
Croatian: Nakon primjene aztreonama za injekciju aztreonam se izlučuje u majčino mlijeko u vrlo malim koncentracijama.
English: How to take Cayston using the Altera Nebuliser Handset
Croatian: Kako uzeti Cayston pomoću ručnog atomizatora Altera
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Croatian: POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN I POGLEDA
English: The elimination half-life of aztreonam from serum is approximately 2.1 hours for inhalation administration, similar to what has been reported for aztreonam for injection.
Croatian: Poluvrijeme eliminacije aztreonama iz seruma iznosi približno 2,1 sat za primjenu inhalacijom, što je slično zabilježenom poluvremenu aztreonama za injekciju.
English: Rash has been reported with the use of Cayston and may be indicative of an allergic reaction to aztreonam (see section 4.4).
Croatian: Uz primjenu Caystona zabilježen je osip, koji može ukazivati na alergijsku reakciju na aztreonam (vidjeti dio 4.4).
English: Cayston is indicated for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older.
Croatian: Cayston je indiciran za supresivnu terapiju kroničnih plućnih infekcija uzrokovanih s Pseudomonas aeruginosa u bolesnika s cističnom fibrozom (CF) u dobi od 6 godina i starijih.
English: Solvent ampoules must be separated by gently pulling them apart.
Croatian: Ampule s otapalom moraju se nježno razdvojiti jedna od druge.