FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, doses of Quinsair do not need to be adjusted in patients with mild to moderate renal impairment.
Slovenian: Zato odmerkov zdravila Quinsair pri bolnikih z blago do zmerno okvaro ledvic ni treba prilagajati.
English: if you have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or vascular EhlersDanlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure, or known atherosclerosis).
Slovenian: če imate družinsko zdravstveno zgodovino aortne anevrizme ali aortne disekcije ali druge dejavnike tveganja ali stanja, ki povečajo nagnjenost k nastanku teh bolezni (npr. vezivnotkivne bolezni, kot je Marfanov sindrom, ali žilne oblike Ehlers-Danlosovega sindroma ali žilne bolezni, kot so Takayasujev arteritis, velikocelični arteritis, Behçetova bolezen, visok krvni tlak ali znana ateroskleroza).
English: Median time to administration of anti-pseudomonal antimicrobials
Slovenian: Mediani čas do uporabe zdravil, ki delujejo proti bakteriji Pseudomonas
English: However, dose adjustments were not employed in clinical studies of Quinsair which allowed for the inclusion of patients with mild to moderate renal impairment (estimated creatinine clearance ≥ 20 ml/min using the Cockcroft-Gault formula in adult patients and ≥ 20 ml/min/1.73 m2 using the Bedside Schwartz formula in patients < 18 years old).
Slovenian: Vendar pa odmerkov v kliničnih študijah z zdravilom Quinsair niso prilagajali, kar je omogočilo vključitev bolnikov z blago do zmerno okvaro ledvic (ocenjeni kreatininski očistek ≥ 20 ml/min z uporabo Cockcroft-Gaultove formule pri odraslih bolnikih in ≥ 20 ml/min/1,73 m2 z uporabo Bedside
English: Keeping the handset level, place the mouthpiece in the patient's mouth making sure their lips are closed around it.
Slovenian: Nebulator držite ravno in ustnik vstavite v bolnikova usta; bolnik naj ustnice sklene okoli ustnika.
English: Respiratory domain of Cystic Fibrosis Questionnaire - Revised (CFQ-R)
Slovenian: Revidirani vprašalnik za cistično fibrozo, poglavje Dihala (CFQ-R, Respiratory domain of Cystic Fibrosis QuestionnaireRevised)
English: Multiple dose administration of Quinsair 240 mg twice daily by inhalation results in levofloxacin systemic exposure approximately 50% lower than that observed following systemic administration of comparable doses (see Table 3).
Slovenian: Večkratno odmerjanje zdravila Quinsair 240 mg dvakrat na dan z inhaliranjem je povzročilo sistemsko izpostavljenost levofloksacinu, ki je bila približno 50% nižja kot tista, ki so jo opazili po sistemskem dajanju primerljivih odmerkov (glejte preglednico 3).
English: The information that appears on the ampoule is:
Slovenian: Podatki na ampuli so:
English: - Check that your Zirela Nebuliser System works properly before starting your treatment.
Slovenian: - Pred začetkom zdravljenja se prepričajte, da sistem nebulatorja Zirela pravilno deluje.
English: Quinsair 240 mg once daily.
Slovenian: Zdravilo Quinsair 240 mg dvakrat na dan
English: Theophylline, fenbufen or similar non-steroidal anti-inflammatory drugs No pharmacokinetic interactions of levofloxacin were found with theophylline in a clinical study.
Slovenian: Teofilin, fenbufen ali podobna nesteroidna protivnetna zdravila V klinični študiji niso ugotovili farmakokinetičnega medsebojnega delovanja med levofloksacinom in teofilinom.
English: N = 93 90.5 days
Slovenian: N = 93 90,5 dni
English: If you have used more Quinsair than you should, tell your doctor as soon as possible.
Slovenian: Če ste uporabili večji odmerek zdravila Quinsair, kot bi smeli Če ste uporabili več zdravila Quinsair, kot bi smeli, to čim prej povejte zdravniku.
English: N = 93 110 days
Slovenian: N = 93 110 dni
English: Quinsair 240 mg BID N = 189
Slovenian: Zdravilo Quinsair 240 mg dvakrat na dan N = 189
English: How to use Quinsair
Slovenian: Kako uporabljati zdravilo Quinsair
English: Quinsair is used to treat lung infections caused by Pseudomonas aeruginosa in adults with cystic fibrosis.
Slovenian: Zdravilo Quinsair se uporablja za zdravljenje pljučnih okužb, ki jih povzroča bakterija Pseudomonas aeruginosa pri odraslih s cistično fibrozo.
English: Following systemic administration, levofloxacin obeys linear pharmacokinetics over a range of 50 to 1000 mg.
Slovenian: Po sistemskem dajanju je farmakokinetika levofloksacina v razponu od 50 do 1.000 mg linearna.
English: Quinsair should be taken by inhalation using a Zirela Nebuliser Handset (including a Zirela Aerosol Head).
Slovenian: Zdravilo Quinsair se uporablja z inhaliranjem s pomočjo nebulatorja Zirela (vključno s pršilno glavo Zirela).
English: Insomnia*
Slovenian: nespečnost *
English: - Seizures and convulsions
Slovenian: - Epileptični napadi in konvulzije
English: It is recommended that patients should not expose themselves unnecessarily to strong sunlight or to artificial UV rays (e.g. sunray lamp, solarium) during treatment and for 48 hours following treatment discontinuation in order to prevent photosensitisation.
Slovenian: Bolnikom se med zdravljenjem in še 48 ur po prenehanju odsvetuje nepotrebno izpostavljanje močni sončni svetlobi ali umetnim virom žarkov UV (npr. UV-svetilke, solariji), da se prepreči fotosenzibilizacija.
English: Visual disturbance*
Slovenian: motnje vida*
English: Final study report - by Q2 2022.
Slovenian: Kumulativne vmesne analize - letno Končno poročilo o študijido 2. četrtletja 2022
English: - Photosensitivity
Slovenian: - Fotosenzibilizacija
English: 3) After a few seconds, an aerosol mist will begin to flow into the aerosol chamber of the Zirela Nebuliser Handset.
Slovenian: 3) Po nekaj sekundah bo začel v komoro za aerosol nebulatorja Zirela pršeti aerosol.
English: In Studies 204, 207 and 209, the relative change in FEV1 percent predicted from baseline to the end of treatment in Cycle 1 was of similar magnitude in the 51 adolescents with CF (≥ 12 to < 18 years old and weighing ≥ 30 kg) receiving Quinsair 240 mg twice daily to that in adults.
Slovenian: V študijah 204, 207 in 209 je bila relativna sprememba napovedanega odstotka FEV1 od izhodišča do konca zdravljenja v 1. ciklu pri 51 mladostnikih s CF (≥ 12 do < 18 let s telesno maso ≥ 30 kg), ki so dobivali zdravilo Quinsair 240 mg dvakrat na dan, podobna kot pri odraslih.
English: Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis (CF, see section 5.1).
Slovenian: Zdravilo Quinsair je indicirano za zdravljenje kroničnih pljučnih okužb z bakterijo Pseudomonas aeruginosa pri odraslih bolnikih s cistično fibrozo (CF, glejte poglavje 5.1).
English: Taking Quinsair at the same time as these medicines could increase your risk of a fit (seizure).
Slovenian: Uporaba zdravila Quinsair sočasno s temi zdravili lahko poveča vaše tveganje za konvulzijo (epileptični napad).
English: This should be connected to either an eBase Controller or an eFlow rapid Control Unit.
Slovenian: Povežite ga na krmilnik eBase ali na krmilno enoto eFlow rapid.
English: For the subgroup of patients who received TIS during the Core Phase and switched to Quinsair in the Extension Phase, the improvement in FEV1 percent predicted was more marked on Quinsair than on TIS (LS Mean change in FEV1 percent predicted on TIS ranged between 0.97% to 3.60% across Cycles 1 to 3 and between 4.00% to 6.91% across Cycles 4 to 6 on Quinsair).
Slovenian: Za podskupino bolnikov, ki so v osrednji fazi prejeli raztopino tobramicina za inhaliranje in so v fazi podaljška prešli na zdravilo Quinsair, je bilo izboljšanje napovedanega odstotka FEV1 bolj izrazito za zdravilo Quinsair kot za raztopino tobramicina za inhaliranje (sprememba povprečne vrednosti LS za napovedani odstotek FEV1 pri raztopini tobramicina za inhaliranje je bila v razponu od 0,97% do 3,60% v 1. do 3. ciklu in od 4,00% do 6,91% v 4. do 6. ciklu za zdravilo Quinsair).
English: Levofloxacin is not recommended in patients with a known history of myasthenia gravis.
Slovenian: Levofloksacin se ne priporoča pri bolnikih, za katere je znano, da imajo miastenijo gravis v anamnezi.
English: Hyposmia*, Somnolence*
Slovenian: hipozmija*, zaspanost*
English: The following side effects have also been reported after taking tablets or an intravenous infusion containing levofloxacin, so they might possibly occur after using Quinsair:
Slovenian: Po jemanju tablet ali intravenski infuziji, ki je vsebovala levofloksacin, so poročali tudi o naslednjih neželenih učinkih, zato se lahko morda pojavijo tudi po uporabi zdravila Quinsair:
English: Tendinitis, Costochondritis, Joint stiffness
Slovenian: tendinitis, kostohondritis, togost sklepov
English: Quinsair is not recommended for use in patients with severe renal impairment (creatinine clearance ˂ 20 ml/min).
Slovenian: Uporaba zdravila Quinsair se ne priporoča pri bolnikih s hudo okvaro ledvic (očistek kreatinina ˂ 20 ml/min).
English: General disorders and administration site conditions1
Slovenian: Splošne težave in spremembe na mestu aplikacije1
English: Levofloxacin caused no impairment of fertility or reproductive performance in rats (see section 5.3).
Slovenian: Pri podganah levofloksacin ni vplival na plodnost ali sposobnost razmnoževanja (glejte poglavje 5.3).
English: Quinsair should only be used with the Zirela Nebuliser Handset (including a Zirela Aerosol Head) provided in the pack connected to an eBase Controller or an eFlow rapid Control Unit (see section 6.6).
Slovenian: Zdravilo Quinsair je dovoljeno uporabljati le z nebulatorjem Zirela (vključno s pršilno glavo Zirela), priloženim v pakiranju, povezanim na krmilnik eBase ali krmilno enoto eFlow rapid (glejte poglavje 6.6).
English: Alanine aminotransferase increased, Aspartate aminotransferase increased, Pulmonary function test decreased*, Blood glucose increased and decreased*, Blood creatinine increased* Breath sounds abnormal*
Slovenian: povečanje ravni alaninaminotransferaze povečanje ravni aspartataminotransferaze zmanjšanje vrednosti testov pljučne funkcije*, povečanje in zmanjšanje ravni glukoze v krvi *, povečanje ravni kreatinina v krvi* nenormalni zvoki ob dihanju*
English: However, Quinsair is not recommended for use in patients with severe renal impairment (creatinine clearance ˂ 20 ml/min, see section 4.2).
Slovenian: Vendar pa se uporaba zdravila Quinsair ne priporoča pri bolnikih s hudo okvaro ledvic (očistek kreatinina ˂ 20 ml/min, glejte poglavje 4.2).
English: Uncommon: may affect up to 1 in 100 people - Feeling confused or nervous - Shaking - Sensation of dizziness, spinning or falling over (vertigo) - Excessive sweating
Slovenian: Občasni: pojavijo se lahko pri do 1 od 100 bolnikov - občutek zmedenosti ali živčnosti - tresenje - občutek omotice, vrtenja ali omedlevanja (vertigo) - pretirano znojenje
English: The Manufacturer's Instructions for Use of the Zirela Nebuliser System should be reviewed prior to the first use of Quinsair.
Slovenian: Pred prvo uporabo zdravila Quinsair je treba prebrati proizvajalčeva navodila za uporabo nebulatorskega sistema Zirela.
English: Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely.
Slovenian: Redko se lahko pojavita bolečina in oteklina sklepov ter vnetje ali pretrganje tetiv.
English: Airway clearance techniques;
Slovenian: 3. tehnike čiščenja dihalnih poti,
English: N = 189 141 days
Slovenian: N = 189 141 dni
English: Quinsair may make you feel dizzy, tired or weak, or cause problems with your eyesight.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zaradi zdravila Quinsair boste morda omotični, utrujeni ali šibki ali pa boste imeli težave z vidom.
English: 56 (14 sachets of 4) ampoules.
Slovenian: 56 ampul (14 vrečic s po 4 ampulami).
English: Do not use Quinsair: - if you are allergic to levofloxacin, to any other quinolone antibiotics, such as moxifloxacin,
Slovenian: Ne uporabljajte zdravila Quinsair: - če ste alergični na levofloksacin, kateri koli drugi kinolonski antibiotik, kot so moksifloksacin, ciprofloksacin ali ofloksacin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: This comprises an inner carton box containing 56 ampoules and a Package Leaflet.
Slovenian: Sestavljata ga notranja škatla, ki vsebuje 56 ampul, in navodilo za uporabo.
English: However, in the absence of human data and findings in non-clinical studies suggesting a risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, use of Quinsair is contraindicated during pregnancy (see sections 4.3 and 5.3).
Slovenian: Ker pa ni podatkov pri človeku in ker ugotovitve predkliničnih študij kažejo na tveganje, da fluorokinoloni poškodujejo nosilni hrustanec rastočega organizma, je uporaba zdravila Quinsair med nosečnostjo kontraindicirana (glejte poglavji 4.3 in 5.3).
English: Any unused product must be thrown away.
Slovenian: Vso neuporabljeno zdravilo morate zavreči.
English: Do not use this medicine after the expiry date which is stated on the ampoule, the foil sachet and the boxes after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ampuli, vrečici iz folije in škatlah poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: - Severe skin reactions
Slovenian: - Hude kožne reakcije.
English: Fatigue/asthenia, Exercise tolerance decreased
Slovenian: utrujenost/astenija, zmanjšana zmožnost vadbe pireksija
English: (Note: In Study 204, an additional 38 patients were randomised to Quinsair 120 mg once daily (≥ 18 years, n = 35; ≥ 16 to < 18 years old, n = 3) and an additional 37patients were randomised to Quinsair 240 mg once daily (≥ 18 years, n = 34; ≥ 16 to < 18 years old, n = 3).)
Slovenian: (Opomba: V študiji 204 je bilo dodatnih 38 bolnikov randomiziranih za zdravilo Quinsair 120 mg enkrat na dan (≥ 18 let, n = 35; ≥ 16 do < 18 let, n = 3) in dodatnih 37 bolnikov je bilo randomiziranih za zdravilo Quinsair 240 mg enkrat na dan (≥ 18 let, n = 34; ≥ 16 do < 18 let, n = 3).)
English: 3 ml, Low density polyethylene ampoule.
Slovenian: 3 ml ampula iz polietilena nizke gostote
English: Rare: may affect up to 1 in 1,000 people - Hallucinations and/or feeling paranoid - Feeling agitated - Unusual dreams or nightmares - Convulsions (fits) - Tingling sensation (pins and needles) and/or numbness - Palpitations - Low blood pressure - Muscle weakness
Slovenian: Redki: pojavijo se lahko pri do 1 od 1.000 bolnikov - halucinacije in/ali občutek paranoidnosti - občutek vznemirjenosti - neobičajne sanje ali nočne more - konvulzije (krči) - občutek ščemenja (mravljinčenja) in/ali odrevenelosti - palpitacije - nizek krvni tlak - mišična oslabelost
English: • Hypersensitivity to the active substance, other quinolones or to any of the excipients listed in section 6.1.
Slovenian: • Preobčutljivost na zdravilno učinkovino, druge kinolone ali katero koli pomožno snov,
English: Outer box
Slovenian: Zunanja škatla
English: In the absence of human data and findings in non-clinical studies suggesting a risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, use of Quinsair is contraindicated in breast-feeding women (see sections 4.3 and 5.3).
Slovenian: Ker ni podatkov pri človeku in ker ugotovitve predkliničnih študij kažejo na tveganje, da fluorokinoloni poškodujejo nosilni hrustanec rastočega organizma, je uporaba zdravila Quinsair pri doječih ženskah kontraindicirana (glejte poglavji 4.3 in 5.3).
English: Adult and adolescent (≥ 12 to < 18 years old and weighing ≥ 30 kg) patients who had a FEV1 percent predicted between 25% and 85% were enrolled.
Slovenian: Vključeni bolniki so bili odrasli in mladostniki (≥ 12 do < 18 let s telesno maso ≥ 30 kg) s predvidenim odstotkom FEV1 med 25% in 85%.
English: Not known: frequency cannot be estimated from the available data - Low numbers of all types of cells in the blood - Diabetic coma - Severe mental problems (which in very rare cases may lead to self-harm) - Pain, burning, tingling, numbness and/or weakness in the limbs (neuropathy) - Involuntary muscle movements, twitching or spasms - Fainting - Severe throbbing headaches with loss of eyesight - Temporary loss of vision - Rapid or abnormal heart beat - Inflammation of the lung - Severe skin reactions such as painful blistering or lesions possibly in the mouth, nose or vagina - Increased sensitivity of the skin to sunlight or UV light (sunbeds or other UV lamps) - Inflammation of the blood vessels - Inflammation of the mouth or lips - Rapid breakdown of muscles - Inflammation of a tendon or a broken tendon - Pain including pain in the back, chest, arms and legs and arms
Slovenian: Neznani: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti - nizko število vseh vrst krvnih celic - diabetična koma - hude duševne težave (ki lahko v zelo redkih primerih povzročijo samopoškodovanje) - bolečina, skelenje, ščemenje, odrevenelost in/ali šibkost okončin (nevropatija) - nehotni mišični gibi, trzanje ali spazmi - omedlevica - hudi utripajoči glavoboli z izgubo vida - začasna izguba vida - hiter ali nenormalen srčni utrip - vnetje pljuč - hude kožne reakcije, kot so boleči mehurji ali lezije, po možnosti v ustih, nosu ali nožnici - večja občutljivost kože na svetlobo ali UV-žarke (solarije ali druge UV-svetilke) - vnetje krvnih žil - vnetje ust ali ustnic - hitra razgradnja mišic - vnetje tetive ali raztrganje tetive - bolečine, vključno z bolečino v hrbtu, prsnem košu, rokah in nogah
English: Fluoroquinolones have been shown to cause arthropathy in weight-bearing joints of immature animals.
Slovenian: Pokazalo se je, da fluorokinoloni povzročajo artropatijo nosilnih sklepov pri mladih živalih.
English: In clinical trials, 51 adolescents with CF (≥ 12 to < 18 years old) received Quinsair 240 mg twice daily and 6 adolescents with CF received Quinsair 120 mg (n = 3) or 240 mg (n = 3) once daily.
Slovenian: V kliničnih preskušanjih je 51 mladostnikov s CF (≥ 12 do < 18 let) dvakrat na dan prejemalo 240 mg zdravila Quinsair in 6 mladostnikov s CF je enkrat na dan prejemalo 120 mg zdravila Quinsair (n = 3) ali 240 mg zdravila Quinsair (n = 3).
English: If you experience any of these side effects after taking Quinsair, contact your doctor immediately prior to continuing treatment.
Slovenian: Če se po uporabi zdravila Quinsair pojavi kateri koli od teh neželenih učinkov, se takoj obrnite na zdravnika, tj. preden nadaljujete z zdravljenjem.
English: Musculoskeletal and connective tissue disorders1
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva1
English: 2) Hold the handset level, press and hold the on/off button on the controller for a few seconds.
Slovenian: 2) Nebulator držite ravno ter pritisnite in za nekaj sekund držite gumb za vklop/izklop na krmilniku.
English: N = 189 131 days
Slovenian: N = 189 131 dni
English: Cases of hepatic necrosis up to fatal hepatic failure have been reported with systemically administered levofloxacin, primarily in patients with severe underlying diseases (e.g. sepsis, see section 4.8).
Slovenian: Ob sistemskem jemanju levofloksacina so bili opisani primeri jetrne nekroze, vključno z življenjsko ogrožajočo jetrno odpovedjo, v glavnem pri bolnikih z resnimi primarnimi obolenji, npr. sepso (glejte poglavje 4.8).
English: All patients had also received a minimum of 3 courses of inhaled anti-pseudomonal antimicrobial therapy in the 12 months (Study 204) or 18 months (Study 207) prior to entry into the study, but none in the 28 days immediately preceding study entry.
Slovenian: Vsi bolniki so v 12 mesecih (študija 204) ali 18 mesecih (študija 207) pred vključitvijo v študijo prejeli tudi vsaj 3 cikle inhalacijske protimikrobne terapije proti bakteriji Pseudomonas, vendar ne v 28 dneh tik pred vstopom v študijo.
English: Quinsair is administered by inhalation over a 5 minute period using a Quinsair specific Zirela Nebuliser Handset and Zirela Aerosol Head connected to an eBase Controller or an eFlow rapid Control Unit (see section 4.2).
Slovenian: Zdravilo Quinsair se daje kot 5-minutne inhalacije z uporabo nebulatorja Zirela, specifičnega za zdravilo Quinsair, in pršilne glave Zirela, ki se priključi na krmilnik eBase ali krmilno enoto eFlow rapid (glejte poglavje 4.2).
English: Pancytopenia*, Agranulocytosis*, Haemolytic anaemia*
Slovenian: Bolezni krvi in limfatičnega sistema pancitopenija*, agranulocitoza*, hemolitična anemija*
English: Doses do not need to be adjusted in patients with mild to moderate renal impairment (estimated creatinine clearance ≥ 20 ml/min using the Cockcroft-Gault formula).
Slovenian: Odmerkov pri bolnikih z blago do zmerno okvaro ledvic (ocenjen očistek kreatinina ≥ 20 ml/min po Cockcroft-Gaultovi formuli) ni treba prilagajati.
English: Symptoms include: - General itching and feeling of heat - especially affecting the scalp, mouth, throat, palms or soles of your feet - Severe wheezing, or noisy or difficult breathing - Severe hives/nettle rash - Swelling of the lips, face, throat or tongue - Pale or greyish skin colour - A fast heart beat - Faintness or passing out
Slovenian: Simptomi vključujejo: - splošno srbenje in občutek vročine, zlasti po lasišču, ustih, žrelu, dlaneh ali podplatih - hudo sopenje ali glasno oz. težko dihanje - hudo koprivnico/urtikarijo - oteklost ustnic, obraza, žrela ali jezika - bledo ali sivkasto barvo kože - hiter srčni utrip - omedlevico ali izgubo zavesti
English: CDAD may range in severity from mild to life-threatening, the most severe form of which is pseudomembranous colitis.
Slovenian: Bolezni, povezane s Clostridium difficile, so različno resne, od blagih do življenjsko nevarnih, med njimi pa je najhujša oblika psevdomembranski kolitis.
English: Vulvovaginal mycotic infection
Slovenian: Infekcijske in parazitske bolezni vulvovaginalna mikotična okužba ustna glivična okužba
English: Quinolones may lower the seizure threshold and may trigger seizures (see section 4.8).
Slovenian: Kinoloni lahko znižajo prag konvulzivnih napadov in sprožijo napade (glejte poglavje 4.8).
English: - Liver problems.
Slovenian: - Težave z jetri.
English: A total of 189 patients were randomised to Quinsair 240 mg twice daily (≥ 18 years, n = 170; ≥ 12 to < 18 years old, n = 19) and 93 were randomised to TIS (≥ 18 years, n = 84; ≥ 12 to < 18 years old, n = 9).
Slovenian: Skupaj 189 bolnikov je bilo randomiziranih za zdravilo Quinsair 240 mg dvakrat na dan (≥ 18 let, n = 170; ≥ 12 do < 18 let, n = 19) in 93 jih je bilo randomiziranih za TIS (≥ 18 let, n = 84; ≥ 12 do < 18 let, n = 9).
English: Squeeze all of the contents of one ampoule into the medicine reservoir of the Zirela Nebuliser Handset.
Slovenian: Vso vsebino ene ampule iztisnite v vsebnik za zdravilo nebulatorja Zirela.
English: Coagulation tests, therefore, should be monitored in patients treated with vitamin K antagonists (see section 4.4).
Slovenian: Pri bolnikih, ki dobivajo antagoniste vitamina K, je zato treba spremljati koagulacijske teste (glejte poglavje 4.4).
English: If acute symptomatic bronchospasm occurs after receiving Quinsair, patients may benefit from the use of a short-acting inhaled bronchodilator at least 15 minutes to 4 hours prior to subsequent doses (see sections 4.4 and 4.8).
Slovenian: Če se po uporabi zdravila Quinsair pojavi akutni simptomatski bronhospazem, bo bolniku morda koristil kratkodelujoči inhalirani bronhodilatator, ki ga mora uporabiti vsaj 15 minut do 4 ure pred naslednjimi odmerki (glejte poglavji 4.4 in 4.8).
English: 3.56 micrometres (1.51 geometric standard deviation); drug delivery rate: 24.86 mg/minute (4.05 standard deviation, SD) and total drug delivered: 236.1 mg (7.1 SD).
Slovenian: Študije in vitro z uporabo nebulatorskega sistema Zirela z zdravilom Quinsair so pokazale naslednje značilnosti dostave zdravila: masni mediani aerodinamični premer (porazdelitev velikosti kapljic): 3,56 mikrometrov (1,51 geometrični standardni odklon); hitrost dostave zdravila: 24,86 mg/minuto (4,05 standardni odklon, SD (standard deviation)) in celokupna dostava zdravila: 236,1 mg (7,1 SD).