FrancophonIA/ELRC3.0 huggingface dataset:
English: In a 24-week active-controlled clinical study of Cayston therapy, increases were observed in the MIC90 for all P. aeruginosa isolates as well as in the percentages of patients with P. aeruginosa resistant (MIC above the parenteral breakpoint) to aztreonam, to at least 1 beta-lactam antibiotic, and to all 6 beta-lactam antibiotics tested (see section 5.1).
Slovenian: V 24-tedenski aktivno kontrolirani klinični študiji zdravljenja z zdravilom Cayston so opazili povečanje MIK90 za vse izolate povzročitelja P. aeruginosa in povečanje odstotka bolnikov s povzročiteljem P. aeruginosa, odpornim (MIK nad parenteralno mejno vrednostjo) na aztreonam, na vsaj 1 betalaktamski antibiotik in na vseh 6 testiranih betalaktamskih antibiotikov (glejte poglavje 5.1).
English: Cayston should not be reconstituted until a dose is ready to be administered.
Slovenian: Zdravilo Cayston se ne sme rekontituirati, dokler bolnik ni pripravljen na uporabo odmerka.
English: Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill
Slovenian: Gilead Sciences Ireland UC IDA Business & Technology Park
English: pyrexia
Slovenian: pireksija
English: One glass vial containing Cayston is opened by carefully removing the blue cap and the metal ring, and then the grey rubber stopper.
Slovenian: Eno stekleno vialo, ki vsebuje zdravilo Cayston, odprite tako, da previdno odstranite modro zaporko in kovinski obroček ter nato še siv gumijast zamašek.
English: The unopened vials may also be stored outside the refrigerator but below 25°C for up to 28 days.
Slovenian: Neodprte viale lahko shranjujete tudi zunaj hladilnika na temperaturi do 25 °C do 28 dni.
English: After reconstitution, immediate use of Cayston is recommended.
Slovenian: Priporoča se, da rekonstituirano raztopino zdravila Cayston takoj uporabite.
English: EU/1/09/543/001: 28-day pack of Cayston
Slovenian: EU/1/09/543/001: 28-dnevni paket zdravila Cayston
English: After a few seconds, an aerosol mist will begin to flow into the Aerosol Chamber of the Altera Nebuliser Handset.
Slovenian: Po nekaj sekundah bo začel v komoro za aerosol kompleta z nebulatorjem Altera pršeti aerosol.
English: Lung function test decreased
Slovenian: Poslabšanje testa pljučne funkcije
English: Patients were randomised in a 2:2:1:1 ratio to be treated with aztreonam 75 mg 2 or 3 times a day or volume-matched placebo 2 or 3 times a day for 28 days immediately following the 28-day lead-in course of open-label TNS.
Slovenian: Bolnike so naključno razporedili v razmerju 2:2:1:1, tako da so prejemali aztreonam 75 mg 2-krat ali 3-krat na dan, ali ustrezno prostornino placeba 2-krat ali 3-krat na dan, 28 dni takoj po 28-dnevnem uvodnem ciklu zdravljenja odprtega prejemanja RTN.
English: Individual patients' plasma aztreonam concentrations exhibited considerable variability.
Slovenian: Koncentracije aztreonama v plazmi posameznih bolnikov so kazale velika nihanja.
English: If any of these apply to you tell your doctor before using Cayston.
Slovenian: Če kar koli od naštetega velja za vas, obvestite svojega zdravnika, preden uporabite zdravilo
English: Sputum concentrations
Slovenian: Koncentracije izpljunka
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.
Slovenian: Zdravilo Cayston je indicirano za supresivno zdravljenje kroničnih pljučnih okužb z bakterijo Pseudomonas aeruginosa pri bolnikih s cistično fibrozo (CF), starih 6 let in več.
English: Follow Step A to D in Figure 1 below to open the amber vial:
Slovenian: Odprite rjavo vialo, tako da sledite korakom od A do D na sliki 1 spodaj:
English: Known mechanisms of resistance to aztreonam mediated by mutation of chromosomal genes include: hyperexpression of the Class C beta-lactamase AmpC and up-regulation of the efflux pump MexAB-OprM.
Slovenian: Znani mehanizmi odpornosti na aztreonam, ki ga povzroči mutacija kromosomskih genov, vključujejo: hiperekspresija betalaktamaze AmpC razreda C in zvišanje ravni protonske črpalke MexAB-OprM.
English: The recommended dose for adults is 75 mg three times per 24 hours for 28 days.
Slovenian: Odrasli in otroci, stari 6 let in več Priporočeni odmerek za odrasle je 75 mg trikrat na 24 ur, 28 dni.
English: Gilead Sciences Ltd Tel: + 44 (0) 8000 113700
Slovenian: United Kingdom Gilead Sciences Ltd Tel: + 44 (0) 8000 113700
English: However, similar improvements in lung function were seen after treatment with Cayston among patients with aztreonam susceptible or resistant P. aeruginosa isolates.
Slovenian: Vendar pa so podobno izboljšanje pljučne funkcije opazili že po zdravljenju z zdravilom Cayston pri bolnikih z izolati povzročitelja P. aeruginosa, občutljivimi ali odpornimi na aztreonam.
English: Among patients with multidrug-resistant P. aeruginosa, improvements in respiratory symptoms and pulmonary function were observed following treatment with Cayston.
Slovenian: Med bolniki z multiplo rezistentnim povzročiteljem P. aeruginosa po zdravljenju z zdravilom Cayston opazili izboljšanja dihalnih simptomov in pljučne funkcije.
English: Entry criteria included CF, baseline FEV1 between 25% and 75% predicted, and chronic P. aeruginosa lung infection.
Slovenian: Merila za sodelovanje so vključevala izhodiščni napovedani odstotek FEV1 za CF od 25% do 75% in kronično pljučno okužbo s P. aeruginosa.
English: Caystonis an antibiotic used to suppress chronic lung infection caused by the bacteria Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis.
Slovenian: Zdravilo Cayston je antibiotik, ki se uporablja za zaviranje kroničnih okužb pljuč, ki jih povzroča bakterija Pseudomonas aeruginosa pri bolnikih, starih 6 let in več, s cistično fibrozo.
English: CP-AI-007 enrolled 164 adult (predominantly) and paediatric patients randomised in a 1:1 ratio comparing Cayston 75 mg (80 patients) or placebo (84 patients) administered 3 times a day for 28 days (one course).
Slovenian: V študiji CP-AI-007 je sodelovalo 164 odraslih (v večini) in pediatričnih bolnikov, ki so bili naključno razporejeni v razmerju 1:1, pri katerih so primerjali zdravilo Cayston 75 mg (80 bolnikov) ali placebo
English: • Pack containing one 28-day pack of Cayston plus one Altera Nebuliser Handset
Slovenian: • Paket, ki vsebuje en 28-dnevni paket zdravila Cayston in en komplet z nebulatorjem Altera
English: The adjusted mean actual change from baseline in FEV1 % predicted across 3 treatment courses was 2.05 and -0.66 in the Cayston and TNS groups, respectively (treatment difference: 2.70; p = 0.0023; 95% CI: 0.98, 4.43).
Slovenian: Prilagojena srednja dejanska sprememba od izhodišča napovedanega odstotka FEV1 % v 3 ciklih zdravljenja je bila 2,05 v skupini z zdravilom Cayston in -0,66 v skupini z RTN (razlika v zdravljenju: 2,70; p = 0,0023; 95-odstotni IZ: 0,98; 4,43).
English: Each 28-day pack of Cayston contains 84 vials of lyophilised aztreonam and 88 solvent ampoules.
Slovenian: En 28-dnevni paket zdravila Cayston vsebuje 84 vial liofiliziranega aztreonama in 88 ampul vehikla.
English: Patients were randomised in a 1:1 ratio to receive either aztreonam (75 mg) administered by inhalation 3 times a day or TNS (300 mg) administered 2 times a day.
Slovenian: Bolniki so bili randomizirani v razmerju 1:1 in so prejemali bodisi aztreonam (75 mg), dan z inhalacijo 3-krat dnevno, ali RTN (300 mg), dan 2 krat dnevno.
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.
Slovenian: Korak B: Pripravite kovinsko tesnilo za odstranitev, tako da povlečete modro zaporko navzdol v vodoravni položaj (tako da je spodnji del modre zaporke obrnjen navzgor).
English: Each 28-day pack of Cayston contains 84 vials of lyophilised Cayston and 88 solvent ampoules.
Slovenian: En 28-dnevni paket zdravila Cayston vsebuje 84 vial liofiliziranega zdravila Cayston in 88 ampul vehikla.
English: Treatments were administered for three cycles of 28 days on therapy followed by 28 days off therapy.
Slovenian: Zdravljenje so dajali tri cikle po 28 dni, nato pa je sledilo 28 dni brez zdravljenja.
English: Cayston is administered by inhalation over a 2 to 3 minute period, using a Cayston specific Altera Nebuliser Handset and Altera Aerosol Head connected to an eBase Controller or an eFlow rapid Control Unit.
Slovenian: Zdravilo Cayston se 2 do 3 minute inhalira z uporabo nebulatorja Altera in glave za izdelavo aerosola za zdravilo Cayston, povezanima s kontrolnikom eBase ali kontrolno enoto eFlow rapid.
English: Take one amber vial of Cayston and one ampoule of solvent from the box.
Slovenian: Iz škatle vzemite eno rjavo vialo zdravila Cayston in eno ampulo vehikla.
English: Close the medicine reservoir by aligning the tabs of the medicine cap with the slots on the reservoir.
Slovenian: Zaprite vsebnik za zdravilo tako, da poravnate jezičke pokrova za zdravilo z zarezami na vsebniku.
English: Preparing the Altera Nebuliser to take your Cayston 1.
Slovenian: Uporaba nebulatorja Altera za uporabo zdravila Cayston 1.
English: Cayston should only be used with the Altera Nebuliser Handset and Altera Aerosol Head connected to an eBase Controller or an eFlow rapid Control Unit.
Slovenian: Zdravilo Cayston se sme uporabljati samo s kompletom z nebulatorjem Altera in glavo za izdelavo aerosola, povezanim s kontrolnikom eBase ali kontrolno enoto eFlow rapid.
English: Powder should only be mixed with the solvent provided.
Slovenian: Prašek se lahko meša samo s priloženim vehiklom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CAYSTON OUTER CARTON (No Blue Box - for use only for co-packaging with Altera Nebuliser Handset)
Slovenian: CAYSTON ZUNANJA ŠKATLA (Brez »blue box« podatkov - samo za uporabo pri skupnem pakiranju s kompletom z nebulatorjem Altera)
English: The adjusted mean percent change from baseline to Day 28 in FEV1 % predicted was 8.35 and 0.55 in the Cayston and TNS groups, respectively (treatment difference: 7.80; p = 0.0001; 95% CI: 3.86, 11.73).
Slovenian: Prilagojena srednja sprememba odstotka od izhodišča na 28. dan napovedanega odstotka FEV1 % je bila 8,35 za skupino, zdravljeno z zdravilom Cayston, in 0,55 za skupino, zdravljeno z RTN (razlika zdravljenja: 7,80; p = 0,0001; 95-odstotni IZ: 3,86; 11,73).
English: Read the manufacturer's instructions for use provided with your Altera Nebuliser System carefully.
Slovenian: Za uporabo sistema nebulatorja Altera skrbno preberite navodila izdelovalca.
English: General disorders and administration site conditions: Very common:
Slovenian: Splošne težave in spremembe na mestu aplikacije:
English: Systemic concentration of aztreonam following inhaled administration of Cayston is approximately 1% of the concentration resulting from a standard dose of aztreonam for injection.
Slovenian: Sistemska koncentracija aztreonama po inhalacijski uporabi zdravila Cayston je približno 1% koncentracije po standardnem odmerku aztreonama za injiciranje.
English: The Altera Nebuliser Handset is designed to last for three 28-day courses of Cayston when used as directed.
Slovenian: Komplet z nebulatorjem Altera je zasnovan tako, da je uporaben tri 28-dnevne cikle zdravljenja z zdravilom Cayston, če se uporablja po navodilih.
English: Breathe normally (inhale and exhale) through the mouthpiece.
Slovenian: Normalno dihajte (vdihujte in izdihujte) skozi ustnik.
English: EU/1/09/543/002: 28-day pack of Cayston plus one Altera Nebuliser Handset
Slovenian: EU/1/09/543/002: 28-dnevni paket zdravila Cayston in en komplet z nebulatorjem Altera
English: You can use either an eBase Controller or an eFlow rapid Control Unit with the Altera Handset.
Slovenian: S kompletom Altera lahko uporabite bodisi kontrolnik eBase ali kontrolno enoto eFlow rapid.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
English: Cayston is contained in a 2 ml amber glass vial with a grey rubber stopper and aluminium tear-off overseal with a blue cap.
Slovenian: Zdravilo Cayston je shranjeno v 2ml rjavi stekleni viali s sivim gumijastim zamaškom in aluminijasto dvižno vrhnjo zaporko z modro zaporko.
English: How to take Cayston
Slovenian: Kako uporabljati zdravilo Cayston
English: Each vial contains aztreonam lysine equivalent to 75 mg aztreonam.
Slovenian: Vsaka viala vsebuje aztreonam lizin ki ustreza 75 mg aztreonama.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij Gilead Sciences Ireland UC
English: Cayston needs to be mixed with a solvent before being inhaled through the Altera Nebuliser.
Slovenian: Zdravilo Cayston morate zmešati z vehiklom pred inhalacijo skozi nebulator Altera.
English: Uncommon side effects (affects 1 to 10 users in 1000) - Joint swelling
Slovenian: Pogosti neželeni učinki (pojavijo se pri 1 do 10 bolnikih od 100 bolnikov) - težave pri dihanju
English: - Do not use Cayston if you notice that the package has been tampered with.
Slovenian: - Ne uporabljajte zdravila Cayston, če opazite znake odpiranja embalaže.
English: Powder vial: Type I amber glass vial with siliconised grey rubber stopper and aluminium tear off overseal with a blue cap.
Slovenian: Viala s praškom: Rjavkasta viala iz stekla vrste I s silikoniziranim sivim gumijastim zamaškom in aluminijasto dvižno vrhnjo zaporko z modro zaporko.
English: No dose adjustment is necessary in cases of renal impairment since the systemic concentration of aztreonam following inhaled administration of Cayston is very low (approximately 1% of the concentration resulting from a dose of 500 mg aztreonam for injection).
Slovenian: Pri okvarjenem delovanju ledvic ni treba prilagajati odmerka, ker je sistemska koncentracija aztreonama po inhalacijski uporabi zdravila Cayston zelo nizka (približno 1% koncentracije po 500 mg odmerka aztreonama za injiciranje).
English: After this time replace your Altera Nebuliser Handset, including the aerosol head.
Slovenian: Po tem obdobju je treba kompleto z nebulatorjem Altera zamenjati skupaj z glavo za izdelavo aerosola.
English: Solvent ampoules must be separated by gently pulling them apart.
Slovenian: Ampule z vehiklom ločite tako, da jih previdno odtrgate eno od druge.
English: - Take Cayston 3 times a day in repeated cycles of 28 days on therapy followed by 28 days off Cayston therapy.
Slovenian: - Zdravilo Cayston uporabite trikrat dnevno v ponavljajočih 28-dnevnih ciklih zdravljenja, ki naj jim sledi 28 dni brez zdravljenja z zdravilom Cayston.
English: Systemic concentration of aztreonam following inhaled administration of Cayston is low compared to a standard dose of aztreonam for injection (approximately 1% of the concentration resulting from a dose of 500 mg aztreonam for injection).
Slovenian: Sistemska koncentracija aztreonama po inhalacijski uporabi zdravila Cayston je nizka v primerjavi s standardnim odmerkom aztreonama za injiciranje (približno 1% koncentracije po odmerku 500 mg aztreonama za injiciranje).
English: You must use the Cayston specific Altera Nebuliser Handset containing an Altera Aerosol Head.
Slovenian: Uporabljajte za zdravilo Cayston posebni komplet z nebulatorjem Altera, ki ima glavo za izdelavo aerosola Altera.
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.
Slovenian: V kliničnih študijah, v katerih so aztreonam uporabljali sočasno z bronhodilatatorji, dornazo alfa, encimi trebušne slinavke, azitromicinom, tobramicinom, peroralnimi steroidi (manj kot 10 mg na dan/20 mg vsak drugi dan) in inhaliranimi steroidi niso opazili znakov kakršnega koli medsebojnega delovanja zdravil z zdravilom Cayston.
English: Pyrexia was observed at a higher incidence rate in paediatric patients aged 6 to 17 years compared to adults.
Slovenian: Pri pediatričnih bolnikih, starih 6 do 17 let, so opazili višjo stopnjo incidence pireksije v primerjavi z odraslimi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (Outer carton containing one 28-day pack of Cayston and one Altera Nebuliser Handset with a Blue Box)
Slovenian: ZUNANJA ŠKATLA (Zunanja škatla vključno z »blue box« podatki vsebuje en 28-dnevni paket zdravila Cayston in en komplet z nebulatorjem Altera)
English: Musculoskeletal and connective tissue disorders: Common:
Slovenian: izpuščaj1 Bolezni mišično-skeletnega sistema in vezivnega tkiva:
English: Treatment with up to nine 28-day courses of 75 mg 3 times a day Cayston therapy resulted in clinically important improvements in respiratory symptoms, pulmonary function, and sputum
Slovenian: Rezultat do devetih 28-dnevnih ciklov zdravljenja z zdravilom Cayston 75 mg trikrat dnevno je bilo klinično pomembno izboljšanje dihalnih simptomov, delovanja pljuč in gostote CFU izpljunka povzročitelja P. aeruginosa CFU.
English: - The powder vial contains 75 mg aztreonam (as lysine).
Slovenian: - Viala s praškom vsebuje 75 mg aztreonama (kot lizin).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CAYSTON OUTER CARTON (With a Blue Box - Not for co-packaging with the Altera Nebuliser Handset)
Slovenian: CAYSTON ZUNANJA ŠKATLA (Vključno z »blue box« podatki - Ni za skupno pakiranje s kompletom z nebulatorjem Altera)
English: Cayston is not for use in children under the age of 6 years.
Slovenian: Otroci, mlajši od 6 let, ne smejo uporabljati zdravila Cayston.
English: Cayston is a white to off-white powder and solvent for nebuliser solution.
Slovenian: Zdravilo Cayston je bel do sivkasto bel prašek in vehikel za inhalacijsko raztopino za nebulator.
English: How to take Cayston using the Altera Nebuliser Handset
Slovenian: Kako uporabljati zdravilo Cayston s kompletom z nebulatorjem Altera
English: Continue to inhale and exhale comfortably until the treatment is finished.
Slovenian: Ne dihajte skozi nos. Sproščeno vdihujte in izdihujte do konca zdravljenja.
English: County Cork
Slovenian: Carrigtohill County Cork Irska
English: Powder vial and solvent ampoule:
Slovenian: Viala s praškom in ampula z vehiklom:
English: An association between persistent isolation of MRSA and worse clinical outcome has been reported in the literature.
Slovenian: V literaturi poročajo o povezavi med persistentno izolacijo bakterije MRSA in poslabšanjem kliničnega izida.
English: Each 28-day course of Cayston was followed by a 28-day off drug period.
Slovenian: Vsakemu 28-dnevnemu ciklu zdravljenja je sledilo 28-dnevno obdobje brez jemanja zdravila.
English: arthralgia
Slovenian: artralgija
English: Gilead Sciences Belgium SPRL-BVBA Tél/Tel: + 32 (0) 2 401 35 50
Slovenian: België/Belgique/Belgien Gilead Sciences Belgium SPRL-BVBA Tél/Tel: + 32 (0) 2 401 35 50
English: Cayston should only be reconstituted with the solvent provided.
Slovenian: Zdravilo Cayston se lahko rekonstituira samo s priloženim vehiklom.
English: For the combined Phase 3 placebo-controlled studies, ten minutes following a single dose of 75 mg inhaled aztreonamon Days 0, 14, and 28, the mean sputum concentrations in 195 patients with CF were 726 µg/g, 711 µg/g, and 715 µg/g, respectively, indicating no increased accumulation of aztreonam following repeated dosing.
Slovenian: 14., in 28. dan srednje koncentracije v izpljunku pri 195 bolnikih s CF 726 µg/g, 711 µg/g oz. 715 µg/g, kar kaže, da ni povečane akumulacije aztreonama po večkratni uporabi.
English: Individual patients' sputum aztreonam concentrations exhibited considerable variability.
Slovenian: Koncentracije aztreonama v izpljunku posameznih bolnikov so kazale velika nihanja.
English: The emergence of parenteral P. aeruginosa resistance to aztreonam or other beta-lactam antibiotics may have potential consequences for the treatment of acute pulmonary exacerbations with systemic antibiotics.
Slovenian: Pojavnost parenteralne odpornosti povzročitelja P. aeruginosa na aztreonam ali druge betalaktamske antibiotike ima lahko potencialne posledice na zdravljenje akutnega poslabšanja pljučne simptomatike s sistemskimi antibiotiki.
English: Powder and solvent for nebuliser solution 42 single-use vials
Slovenian: prašek in vehikel za inhalacijsko raztopino za nebulator 42 vial za enkratno uporabo 44 1-ml ampul vehikla za enkratno uporabo
English: The emergence of parenteral P. aeruginosa resistance to aztreonam and other beta-lactam antibiotics may have potential consequences for the treatment of acute pulmonary exacerbations with systemic antibiotics.
Slovenian: Pojav parenteralne odpornosti povzročitelja P. aeruginosa na aztreonam in druge betalaktamske antibiotike ima lahko potencialne posledice za zdravljenje akutnega poslabšanja pljučne simptomatike s sistemskimi antibiotiki.
English: Gilead Sciences Belgium SPRL-BVBA Tél/Tel: + 32 (0) 2 401 35 79
Slovenian: Luxembourg/Luxemburg Gilead Sciences Belgium SPRL-BVBA Tél/Tel: + 32 (0) 2 401 35 79
English: Powder and solvent for nebuliser solution 84 single-use vials
Slovenian: prašek in vehikel za inhalacijsko raztopino za nebulator 84 vial za enkratno uporabo 88 1-ml ampul vehikla za enkratno uporabo
English: Powder vial also contains L-Lysine Solvent ampoule contains sodium chloride, water for injections
Slovenian: Ampula z vehiklom vsebuje natrijev klorid, vodo za injekcije.
English: In a 24-week active-controlled study of Cayston therapy, no increases in P. aeruginosa MIC50 (± 2 dilution change) were observed, whereas MIC90 increased to 4 times the initial MIC. At the end of the study, the percentage of patients with aztreonam MIC for P. aeruginosa above the parenteral breakpoint (> 8 µg/ml) increased from 34% at baseline to 49%, the percentage of patients with P. aeruginosa resistant to at least 1 betalactam antibiotic increased from 56% at baseline to 67%, and the percentage of patients with P. aeruginosa resistant to all 6 beta-lactam antibiotics tested increased from 13% at baseline to 18%.
Slovenian: (> 8 µg/ml) povečal z izhodiščnih 34 % na 49 %, odstotek bolnikov s povzročiteljem P. aeruginosa, odpornim na vsaj 1 betalaktamski antibiotik, se je povečal z izhodiščnih 56 % na 67 % in odstotek bolnikov s povzročiteljem P. aeruginosa, odpornim na vseh 6 betalaktamskih antibiotikov, se je povečal z izhodiščnih 13 % na 18 %.Obstaja nevarnost, da izolati povzročitelja P. aeruginosa razvijejo odpornost proti aztreonamu ali drugim betalaktamskim antibiotikom pri bolnikih, zdravljenih z zdravilom Cayston.
English: In contrast, the serum concentration of aztreonam following administration of aztreonam for injection (500 mg) is approximately 54 µg/ml.
Slovenian: Za primerjavo je koncentracija aztreonama v serumu po uporabi aztreonama za injiciranje (500 mg)
English: Each powder vial contains 75 mg aztreonam.
Slovenian: Ena viala s praškom vsebuje 75 mg aztreonama.
English: How to store Cayston
Slovenian: Shranjevanje zdravila Cayston
English: No dose adjustment is necessary in cases of hepatic impairment.
Slovenian: Pri okvarjenem delovanju jeter ni treba prilagajati odmerka.
English: Do not mix Cayston with any other medicines in the Altera Nebuliser Handset.
Slovenian: Zdravila Cayston ne mešajte z drugimi zdravili v kompletu z nebulatorjem Altera.
English: Keep the handset level.
Slovenian: - Navodilo shranite.
English: Hepatic impairment
Slovenian: Okvarjeno delovanje ledvic
English: Put the prepared Cayston solution in the Altera Nebuliser Handset (see below).
Slovenian: Pripravljeno raztopino zdravila Cayston vstavite v komplet z nebulatorjem Altera (glejte spodaj).
English: Respiratory, thoracic and mediastinal disorders: Very common:
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora:
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.
Slovenian: Študija CP-AI-006 je bila odprta študija, ki je bila podaljšek študij CP-AI-005 in CP-AI-007.