FrancophonIA/ELRC3.0 huggingface dataset:
English: This helps to ensure that you get the proper dose of medicine.
Croatian: Tako ćete biti sigurni da ćete dobiti pravilnu dozu lijeka.
English: Do not twist the blue cap.
Croatian: Nemojte zavrtati plavu kapicu.
English: Other medicines and Cayston
Croatian: Drugi lijekovi i Cayston
English: Solvent: 3 years.
Croatian: Otapalo: 3 godine.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Croatian: Potrebno je uzeti u obzir službene smjernice za odgovarajuću primjenu antibakterijskih lijekova.
English: Date of first authorisation: 21 September 2009 Date of latest renewal: 26 May 2016
Croatian: Datum posljednje obnove: 26 svibnja 2016.
English: Microbiology
Croatian: Mikrobiologija
English: - if you are allergic to aztreonam or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na aztreonam ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1000 to < 1/100).
Croatian: Učestalosti su definirane na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10) i manje često (≥ 1/1000 i < 1/100).
English: EU/1/09/543/001 EU/1/09/543/002
Croatian: EU/1/09/543/002
English: If you miss a dose, you can still take all 3 daily doses as long as they are at least 4 hours apart.
Croatian: Ako propustite dozu, i dalje možete uzeti sve 3 dnevne doze dokle god ih uzimate u razmacima od najmanje od 4 sata.
English: If you take more Cayston than you should
Croatian: Ako uzmete više Caystona nego što ste trebali
English: If you notice that the performance has changed before this time (for instance, if it takes longer to produce a mist, more than 5 minutes), please refer to the Altera Nebuliser instructions for use.
Croatian: Ako primijetite kakve promjene u radu prije isteka tog vremena (ako, primjerice, stvaranje pare traje dulje, više od 5 minuta), pogledajte upute za upotrebu atomizatora Altera.
English: If you can't leave a gap of 4 hours just skip the missed dose.
Croatian: Ako ne možete održati razmak od 4 sata, samo preskočite propuštenu dozu.
English: The ampoule is imprinted in English only.
Croatian: Podaci na ampuli su tiskani samo na engleskom jeziku.
English: This may be more common in children than in adults.
Croatian: Javlja se češće u djece nego u odraslih.
English: Cayston is not for use in children under the age of 6 years.
Croatian: Cayston nije namijenjen djeci mlađoj od 6 godina.
English: Each treatment takes about 2 to 3 minutes to inhale.
Croatian: Za inhaliranje svake doze potrebno je otprilike 2 do 3 minute.
English: Carefully remove (but do not yet discard) the rubber stopper.
Croatian: Oprezno izvadite gumeni čep (ali nemojte ga još baciti).
English: If you get a rash, tell your doctor immediately because this could mean that you have an allergic reaction to Cayston.
Croatian: Ako dobijete osip, smjesta se obratite liječniku jer to može značiti da imate alergijsku reakciju na
English: Powder vial: 4 years.
Croatian: Bočica s praškom: 4 godine.
English: Hold the handset level and place the mouthpiece in your mouth and close your lips around it (Figure 4).
Croatian: stavite nastavak za usta u usta i priljubite usne oko njega (Slika 4).
English: However, all mean sputum concentration values were associated with relatively large standard deviations.
Croatian: No, sve prosječne vrijednosti koncentracije u iskašljaju bile su povezane s relativno velikim standardnim odstupanjima.
English: If you have ever coughed up blood you should only use Cayston if your doctor thinks the benefit of taking this medicine outweighs the risk of coughing up blood.
Croatian: Ako ste ikada iskašljavali krv, smijete primijeniti Cayston samo ako Vaš liječnik smatra da su prednosti uzimanja ovog lijeka veće od rizika iskašljavanja krvi.
English: The safety and efficacy of Cayston in children younger than 6 years of age have not been established.
Croatian: Sigurnost i djelotvornost Caystona u djece mlađe od 6 godina nije ustanovljena.
English: If a case of bronchospasm is suspected to be part of an allergic reaction appropriate measures should be taken (see “allergic reactions” paragraph above).
Croatian: Ako se posumnja da je bronhospazam dio alergijske reakcije, potrebno je poduzeti odgovarajuće mjere (vidjeti prethodni odlomak “Alergijske reakcije”).
English: Keep the handset level.
Croatian: Držite ručnu napravu ravno.
English: Refer to section 4.4.
Croatian: Pogledajte dio 4.4.
English: If Cayston is to be prescribed to the elderly then the posology is the same as for adults.
Croatian: Ako se Cayston propisuje starijim osobama, doziranje je isto kao i za odrasle.
English: You will hear one “beep” and the status light will turn green.
Croatian: Začut ćete jedan zvučni signal, a žaruljica stanja zasvijetlit će zeleno.
English: Doses should be taken at least 4 hours apart.
Croatian: Doze treba uzimati u razmacima od najmanje 4 sata.
English: The 1 ml solvent is contained in a plastic ampoule.
Croatian: 1 ml otapala nalazi se u plastičnoj ampuli.
English: Press and hold the On/Off button on the Control Unit for a few seconds.
Croatian: Pritisnite tipku za uključivanje/isključivanje na kontrolnoj jedinici na nekoliko sekundi.
English: Cayston should not be used during pregnancy unless the clinical condition of the woman requires treatment with aztreonam.
Croatian: Cayston se ne smije primjenjivati tijekom trudnoće, osim ako kliničko stanje žene ne zahtijeva liječenje aztreonamom.
English: There are no data from the use of aztreonam in pregnant women.
Croatian: Nema podataka o primjeni aztreonama u trudnica.
English: What Cayston is and what it is used for What you need to know before you take Cayston How to take Cayston
Croatian: Što je Cayston i za što se koristi Što morate znati prije nego počnete uzimati Cayston
English: Recovery data indicate that about 10% of the dose is excreted as this metabolite.
Croatian: Podaci o izlučenim spojevima ukazuju da se otprilike 10% doze izluči u obliku ovog metabolita.
English: Patients continued on their baseline medications, including macrolide antibiotics.
Croatian: Bolesnici su nastavili primati osnovne lijekove, uključujući makrolidne antibiotike.
English: You may get a temporary lowering of lung function test result during treatment with Cayston, but this is typically not a lasting effect.
Croatian: Možda ćete iskusiti privremeno smanjenje rezultata testiranja funkcije pluća tijekom liječenja Caystonom, no to obično ne traje dugo.
English: The four additional solvent ampoules are provided in case of spillage.
Croatian: Četiri dodatne ampule s otapalom isporučuju se za slučaj prolijevanja.
English: Continue to inhale and exhale comfortably until the treatment is finished.
Croatian: Nastavite udisati i izdisati bez naprezanja dok se tretman ne završi.
English: The majority of the treatment-emergent isolations were intermittent.
Croatian: Većina izolacija prouzročenih liječenjem bila je povremena.
English: When treatment is complete, open the medicine cap to ensure that all medicine has been used.
Croatian: Po završetku liječenja otvorite čep za lijek da biste provjerili je li primijenjen sav lijek.
English: Cayston is not expected to affect your ability to drive or use machines.
Croatian: Ne očekuje se da bi Cayston mogao utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
English: The principal metabolite (SQ26,992) is inactive and is formed by opening of the beta-lactam ring due to hydrolysis.
Croatian: Glavni metabolit (SQ26992) je inaktivan te se stvara otvaranjem beta-laktamskog prstena uslijed hidrolize.
English: If for any reason you must stop the treatment before you have finished, press and hold the On/Off button for one full second.
Croatian: 8. Ako iz bilo kojeg razloga morate prekinuti liječenje prije završetka, pritisnite i držite tipku za uključivanje/isključivanje jednu punu sekundu.
English: The recommended dose for adults is 75 mg three times per 24 hours for 28 days.
Croatian: Preporučena je doza za odrasle 75 mg tri puta u 24 sata tijekom 28 dana.
English: Pharmacotherapeutic group: Antibacterials for systemic use, other beta-lactam antibacterials, ATC code: J01DF01
Croatian: Farmakoterapijska skupina: Antibakterijski lijekovi za sustavnu primjenu, drugi beta-laktamski antibakterijski lijekovi, ATK oznaka: J01DF01
English: Preparing your Cayston for inhalation
Croatian: Priprema Vašeg Caystona za inhalaciju
English: ESBLs from Class A, B and D beta-lactamases may have activity against aztreonam.
Croatian: ESBL klase A, B i D beta-laktamaza mogu djelovati protiv aztreonama.
English: You can breast-feed during treatment with Cayston because the amount of Cayston likely to be passed to your child during breast-feeding will be extremely small.
Croatian: Tijekom liječenja Caystonom smijete dojiti, jer je količina Caystona koja će se vjerojatno prenijeti Vašem djetetu tijekom dojenja iznimno mala.
English: Use the prepared solution within 8 hours.
Croatian: Pripravljenu otopinu primijenite u roku od 8 sati.
English: Patients received Cayston at the same frequency (2 or 3 times a day) as they took Cayston or placebo in the randomised studies.
Croatian: Bolesnici su primali Cayston jednako često (2 ili 3 puta na dan) kao što su primali Cayston ili placebo u randomiziranim ispitivanjima.
English: When all of the medicine has been delivered, you will hear a tone that means “treatment complete” (2 beeps).
Croatian: Nakon primjene cijelog lijeka začut ćete ton koji označava da je liječenje završeno (dva zvučna signala).
English: The information that appears on the ampoule is presented below:
Croatian: Podaci koji se pojavljuju na ampuli slijede u nastavku:
English: Each of the three doses should be taken by inhalation at least four hours apart, using an Altera Nebuliser Handset.
Croatian: Svaku od triju doza treba uzeti inhalacijom u razmaku od najmanje četiri sata pomoću ručnog atomizatora Altera.
English: Fifty-nine paediatric patients aged 6 to 17 years were included in the study.
Croatian: Pedeset i devet pedijatrijskih bolesnika u dobi od 6 do 17 godina bili su uključeni u ispitivanje.
English: If there is more than a few drops of liquid left, replace the medicine cap and restart treatment.
Croatian: Ako je ostalo više od nekoliko kapi tekućine, vratite čep za lijek i nastavite s liječenjem.
English: As an inhaled medicine, Cayston could cause you to cough and this could lead to coughing up blood.
Croatian: S obzirom da je to lijek za inhaliranje, Cayston može uzrokovati kašalj i to može dovesti do iskašljavanja krvi.
English: Do not try to take Cayston using any other type of nebuliser handset (including the eFlow rapid handset).
Croatian: Nemojte pokušavati uzeti Cayston pomoću neke druge vrste ručnog atomizatora (uključujući atomizator eFlow rapid).
English: Check that your nebuliser works properly before starting your treatment with Cayston.
Croatian: Provjerite radi li atomizator ispravno prije početka liječenja Caystonom.
English: Plasma concentrations
Croatian: Koncentracije u plazmi
English: If an allergic reaction to aztreonam does occur, stop administration of the medicinal product and initiate treatment as appropriate.
Croatian: U slučaju alergijske reakcije na aztreonam, prekinite primjenu lijeka i započnite odgovarajuće liječenje.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u
English: The following side effects have been observed after the use of aztreonam for injection, but not after taking Cayston: swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing, sweating, skin irritation and flaking, itchy rash, flushing, small red spots and very rarely, blistering of the skin.
Croatian: Sljedeće su nuspojave primijećene nakon primjene aztreonama za injekciju, ali ne i nakon primjene Caystona: natečenost lica, usana, jezika i/ili grla uz otežano gutanje ili disanje, znojenje, nadraženost i ljuštenje kože, osip sa svrbežom, crvenilo, male crvene točkice i, vrlo rijetko, pojava mjehurića na koži.
English: bronchodilator mucolytics (a medicine that helps to dissolve the thick mucous produced in the lungs) and finally:
Croatian: bronhodilatator mukolitici (lijek koji pridonosi rastapanju guste sluzi koju proizvode pluća) i na kraju:
English: - Do not prepare Cayston until you are ready to administer a dose.
Croatian: - Nemojte pripremati Cayston dok ne budete spremni za primjenu doze.
English: Clinical studies of Cayston did not include Cayston-treated patients aged 65 years and older to determine whether they respond differently from younger patients.
Croatian: Klinička ispitivanja Caystona nisu uključila dovoljan broj bolesnika liječenih Caystonom u dobi od 65 i više godina da bi se moglo utvrditi razlikuje li se njihov odgovor od odgovora mlađih bolesnika.
English: Data from these studies revealed minimal differences in mean plasma aztreonam concentrations between age groups in patients receiving Cayston 3 times a day.
Croatian: Podaci iz ovih ispitivanja otkrili su minimalne razlike u prosječnim plazmatskim koncentracijama aztreonama između dobnih skupina u bolesnika koji primaju Cayston tri puta dnevno.
English: Figure 3b
Croatian: Slika 3b
English: There are no clinical data on the use of Cayston in pregnant women, therefore you should not take Cayston during pregnancy unless specifically discussed with your doctor.
Croatian: Ne postoje klinički podaci o primjeni Caystona u trudnica pa taj lijek ne biste smjeli uzimati tijekom trudnoće, osim ako to niste izričito razmotrili s liječnikom.
English: Be sure to completely empty the vial.
Croatian: Provjerite jeste li potpuno ispraznili bočicu.
English: Intravenous aztreonam is not suitable for inhalation.
Croatian: Intravenski aztreonam nije prikladan za inhalaciju.
English: Investigations: Common:
Croatian: Pretrage: Često:
English: Squeeze out the contents completely into the vial (Figure 2).
Croatian: Istisnite cijeli sadržaj u bočicu (Slika 2).
English: Plasma aztreonam concentrations in paediatric patients aged 3 months to < 6 years are comparable to those observed for children > 6 years, adolescents and adults.
Croatian: Koncentracije aztreonama u plazmi u pedijatrijskih bolesnika u dobi od 3 mjeseca do < 6 godina usporedive su s onima opaženima u djece u dobi > 6 godina, adolescenata i odraslih.
English: Patients continued on their baseline medications and whenever indicated additional antibiotics were used in the majority of patients to treat exacerbations.
Croatian: Bolesnici su nastavili primati osnovne lijekove, a kad god je to bilo indicirano, egzacerbacije su liječene dodatnim antibioticima u većine bolesnika.
English: Efficacy has not been established in patients with FEV1 > 75% predicted.
Croatian: Djelotvornost Caystona nije utvrđena u bolesnika u kojih je FEV1 bio >75% predviđene vrijednosti.
English: Pyrexia was observed at a higher incidence rate in paediatric patients aged 6 to 17 years compared to adults.
Croatian: Pireksija je primijećena s većom stopom incidencije u pedijatrijskih bolesnika u dobi od 6 do 17 godina u usporedbi s odraslima.
English: Bronchospasm has been reported after Cayston administration (see section 4.8).
Croatian: Bronhospazam je prijavljen nakon primjene Caystona (vidjeti dio 4.8).
English: - Do not use Cayston if you notice that the package has been tampered with.
Croatian: - Cayston nemojte primjenjivati ako primijetite da je pakiranje oštećeno.
English: Do not prepare more than one dose at a time.
Croatian: Nemojte pripravljati više doza odjednom.
English: The dosing in children aged 6 years and older is the same as for adults.
Croatian: Doziranje u djece u dobi od 6 godina i starije jednako je doziranju za odrasle.
English: Patients were required to have been off antipseudomonal antibiotics for at least 28 days before treatment with study drug.
Croatian: Bolesnici nisu smjeli uzimati antipseudomonalne antibiotike u trajanju od najmanje 28 dana prije liječenja ispitivanim lijekom.
English: Figure 3a
Croatian: Slika 3a
English: White to off-white powder.
Croatian: Bijeli do bjelkasti prašak.
English: Aztreonam for injection has not been formulated for inhalation, and contains arginine, a substance known to cause pulmonary inflammation.
Croatian: Aztreonam za injekciju nije formuliran za inhalaciju i sadrži arginin, što je tvar koja dokazano uzrokuje upalu pluća.
English: The vial is then gently swirled until contents have completely dissolved.
Croatian: Bočica se potom lagano okreće dok se sadržaj potpuno ne otopi.
English: - Do not use Cayston if it has been stored outside a refrigerator for more than 28 days.
Croatian: - Cayston nemojte primjenjivati ako se dulje od 28 dana čuvao izvan hladnjaka.
English: Do not stop taking Cayston without first talking to your doctor.
Croatian: Nemojte prestati uzimati Cayston dok se ne posavjetujete s liječnikom.
English: There are rare reports of organisms with metallo-beta-lactamases (MBLs), Class B, that are resistant to aztreonam, VIM-5 (K. pneumoniae and P. aeruginosa - Turkey), VIM-6 (P. putida - Singapore) and VIM-7 (P. aeruginosa - United States), however, it is possible that these organisms were expressing multiple resistance mechanisms and thus a MBL was not responsible for the observed resistance to aztreonam.
Croatian: Postoje rijetka izvješća o mikroorganizmima s metalo-beta-laktamazama (MBL) klase B koji su rezistentni na aztreonam, VIM-5 (K. pneumoniae i P. aeruginosa - u Turskoj), VIM-6 (P. putida - u Singapuru) i VIM-7 (P. aeruginosa - u Sjedinjenim Američkim Državama), međutim, moguće je da ti organizmi izražavaju višestruke mehanizme rezistencije, pa MBL tako nije odgovoran za primijećenu rezistenciju na aztreonam.
English: Aztreonam exhibits activity in vitro against gram-negative aerobic pathogens, including P. aeruginosa.
Croatian: Aztreonam in vitro pokazuje djelovanje protiv gram-negativnih aerobnih patogena, uključujući P. aeruginosa.
English: - Each dose consists of one vial of Cayston mixed with one ampoule of solvent.
Croatian: - Svaka se doza sastoji od jedne bočice Caystona pomiješane s jednom ampulom otapala.
English: However, no evidence of any drug interactions with aztreonam were identified from clinical studies in which Cayston was taken concomitantly with bronchodilators, dornase alfa, pancreatic enzymes, azithromycin, tobramycin, oral steroids (less than 10 mg daily/20 mg every other day) and inhaled steroids.
Croatian: Međutim, nisu pronađeni dokazi o bilo kakvim interakcijama lijekova s aztreonamom u kliničkim ispitivanjima u kojima se Cayston uzimao istovremeno s bronhodilatatorima, dornaza alfom, enzimima gušterače, azitromicinom, tobramicinom, steroidima za peroralnu primjenu (u dozi manjoj od 10 mg na dan ili 20 mg svaki drugi dan) i inhalacijskim steroidima.
English: If you have taken more Cayston than you should, talk to a doctor or pharmacist immediately.
Croatian: Ako uzmete više Caystona nego što ste trebali, smjesta se obratite liječniku ili ljekarniku.
English: Cayston was compared to TNS over three 28-day courses of treatment in a randomised, activecontrolled, multicenter study (GS-US-205-0110).
Croatian: Cayston je uspoređen s TNS-om tijekom tri 28 dnevne kure liječenja u randomizirnom, aktivno kontroliranom, multicentričnom liječenju (GS-US-205-0110).
English: Mechanisms of resistance
Croatian: Mehanizam razvoja rezistencije
English: However, due to the uncontrolled nature of the study and concomitant medications no conclusion can be drawn on the sustainability of the observed short term benefit over subsequent courses of treatment.
Croatian: Međutim, kako samo ispitivanje i istovremeno uzimanje drugih lijekova nisu bili kontrolirani, nije moguće izvesti nikakav zaključak o održivosti primijećene kratkoročne koristi tijekom dodatnih kura liječenja.
English: CP-AI-006 was an open-label follow-on study to CP-AI-005 and CP-AI-007 evaluating the safety of repeated exposure to aztreonamand the effect on disease-related endpoints over multiple 28-day courses.
Croatian: CP-AI-006 je bilo otvoreni nastavak ispitivanja nakon ispitivanja CP-AI-005 i CP-AI-007 kojim se procjenjivala sigurnost ponavljane izloženosti aztreonamu i učinak na ishode povezane s bolešću tijekom više 28-dnevnih kura.
English: There are rare reports of Class D beta-lactamases from clinical isolates of P. aeruginosa, OXA-11 (Turkey) and OXA-45 (United States) that hydrolyse aztreonam.
Croatian: Postoje rijetka izvješća o beta-laktamazama klase D u kliničkim izolatima P. aeruginosa, OXA-11 (u Turskoj) i OXA-45 (u Sjedinjenim Američkim Državama), koje hidroliziraju aztreonam.
English: - Do not use the solvent or prepared Cayston if it is cloudy or if there are particles in the solution.
Croatian: - Otapalo ili pripravljeni Cayston nemojte primjenjivati ako su mutni ili ako u otopini ima čestica.
English: Once treatment is complete, disconnect the Control Unit and take apart the Altera Nebuliser Handset for cleaning and disinfecting.
Croatian: Po dovršetku liječenja odvojite kontrolnu jedinicu i rastavite ručni atomizator Altera radi čišćenja i dezinfekcije.
English: There are no data on the use of Cayston in patients with severe hepatic impairment (ALT or AST greater than 5 times the upper limit of normal).
Croatian: Nema podataka o primjeni Caystona u bolesnika s teškim oštećenjem funkcije jetre (ALT ili AST više od 5 puta iznad gornje granice normale).
English: Systemically absorbed aztreonam is eliminated about equally by active tubular secretion and glomerular filtration.
Croatian: Sistemski apsorbiran aztreonam eliminira se podjednako aktivnim tubularnim izlučivanjem i glomerularnom filtracijom.
English: Aztreonam, a monobactam, is only weakly immunogenic.
Croatian: Aztreonam, kao monobaktamski antibiotik, samo je slabo imunogen.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Cayston in one or more subsets of the paediatric population in cystic fibrosis patients with Pseudomonas aeruginosa pulmonary infection/colonisation (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja Caystona u jednoj ili više podskupina pedijatrijske populacije bolesnika s cističnom fibrozom i plućnom infekcijom/kolonizacijom Pseudomonas aeruginosa (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The following rare and severe adverse reactions have been reported after parenteral use of other aztreonam containing products: toxic epidermal necrolysis, anaphylaxis, purpura, erythema multiforme, exfoliative dermatitis, urticaria, petechiae, pruritus, diaphoresis.
Croatian: Sljedeće rijetke i teške nuspojave prijavljene su nakon parenteralne primjene drugih lijekova koji sadrže aztreonam: toksična epidermalna nekroliza, anafilaksija, purpura, multiformni eritem, eksfolijativni dermatitis, urtikarija, petehije, svrbež, dijaforeza.
English: After a few seconds, an aerosol mist will begin to flow into the Aerosol Chamber of the Altera Nebuliser Handset.
Croatian: Nakon nekoliko sekundi aerosolna para počet će teći u komoru za aerosol ručnog atomizatora Altera.
English: CP-AI-005 enrolled 246 adult (predominantly) and paediatric patients.
Croatian: Ispitivanje CP-AI-005 provedeno je u 246 (uglavnom) odrasla i pedijatrijska bolesnika.
English: If you are using other inhaled therapies to treat cystic fibrosis, the recommended order of use is as follows:
Croatian: Ako cističnu fibrozu liječite drugim inhalacijskim terapijama, preporučeni je redoslijed primjene sljedeći:
English: May be stored outside a refrigerator but below 25°C for up to 28 days.
Croatian: Može se čuvati izvan hladnjaka, ali na temperaturi ispod 25°C do 28 dana.
English: Short acting bronchodilators can be taken between 15 minutes and 4 hours and long acting bronchodilators can be taken between 30 minutes and 12 hours prior to each dose of Cayston.
Croatian: Bronhodilatatori kratkog djelovanja mogu se uzeti između 15 minuta i 4 sata, a bronhodilatatore dugog djelovanja između 30 minuta i 12 sati prije doze