FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor should advise you before using Colobreathe whether the benefits of the medicine exceed the risks.
Croatian: Liječnik Vas mora savjetovati, prije početka primjene lijeka Colobreathe, jesu li koristi primjene veće od rizika.
English: Colistimethate sodium is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se koristiti kolistimetatnatrij tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: One study in cystic fibrosis patients gives the steady-state volume of distribution as 0.09 l/kg.
Croatian: Jedno ispitivanje bolesnika s cističnom fibrozom navodi volumen distribucije u stanju dinamičke ravnoteže od 0,09 l/kg.
English: The capsules must not be swallowed.
Croatian: Kapsule se ne smiju progutati.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http:/www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: • Now, with the capsule locked in place, continue pushing the piston as far as it will go and then release.
Croatian: • Sada, s kapsulom blokiranom u mjestu, nastavite pritiskati klip koliko god ide i zatim ga otpustite.
English: Do not store Colobreathe above 25oC.
Croatian: Ne čuvati Colobreathe na temperaturi iznad 25°C.
English: If you do not hear the capsule spinning, the capsule may be stuck in the compartment.
Croatian: Ako ne čujete da se kapsula okreće, možda se zaglavila u odjeljku.
English: A systemic absorption study showed minimal urinary excretion with less than 3% of the dose of Colobreathe excreted in the urine as colistimethate sodium and colistin.
Croatian: Ispitivanje sistemske apsorpcije lijeka Colobreathe pokazalo je minimalno izlučivanje u urinu s manje od 3% doze lijeka Colobreathe izlučenog u urinu u obliku kolistimetatnatrija i kolistina.
English: Studies in animals using parenteral administration have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama uz parenteralnu primjenu pokazala su reproduktivnu toksičnost (vidjeti dio
English: Colistimethate sodium and colistin have been investigated in vitro to determine the effects on the expression of cytochrome P450 (CYP) enzymes on treating primary cultures of fresh human hepatocytes.
Croatian: Kolistimetatnatrij i kolistin ispitani su in vitro radi utvrđivanja učinaka na ekspresiju enzima citokroma P450 (CYP) pri liječenju primarnih kultura svježe izoliranih ljudskih hepatocita.
English: • Lack of energy, tiredness
Croatian: • nedostatak energije, umor
English: Take care not to cover the air slits with your fingers or mouth during inhalation.
Croatian: Pazite da prilikom udisanja, prstima ili ustima ne prekrijete otvore za zrak.
English: EU/1/11/747/001 56 hard capsules (4 blisters of 14 capsules) EU/1/11/747/002 8 hard capsules (1 blister of 8 capsules) EU/1/11/747/003 56 hard capsules (7 blisters of 8 capsules)
Croatian: EU/1/11/747/001 56 tvrdih kapsula (4 blistera sa 14 kapsula) EU/1/11/747/002 8 tvrdih kapsula (1 blister sa 8 kapsula) EU/1/11/747/003 56 tvrdih kapsula (7 blistera sa 8 kapsula)
English: Caution should be taken with concomitant use with other formulations of colistimethate sodium as there is little experience and there is a possibility of summative toxicity.
Croatian: Potreban je oprez kod istodobne primjene s drugim formulacijama kolistimetatnatrija jer postoje malobrojna iskustva, a postoji i mogućnost od zbrojnog učinka toksičnosti.
English: The Phase 3 clinical study was a randomised, open-label active comparator study comparing the efficacy of colistimethate sodium 1,662,500 IU dry powder for inhalation to tobramycin nebuliser solution for inhalation, 300 mg/5 ml, in 380 subjects with documented cystic fibrosis complicated by chronic pulmonary infection with Pseudomonas aeruginosa.
Croatian: Kliničko ispitivanje faze III bilo je randomizirano, otvoreno ispitivanje s aktivnim poredbenim lijekom, u kojem se uspoređivala djelotvornost 1 662 500 IU kolistimetatnatrija suhog praška za inhalacije s 300 mg/5 ml otopine tobramicina za inhalaciju atomizatorom, u 380 ispitanika s dokumentiranom cističnom fibrozom i komplikacijom kronične plućne infekcije s Pseudomonas aeruginosa.
English: Resistant bacteria are characterised by modification of the phosphate groups of lipopolysaccharide, which become substituted with ethanolamine or aminoarabinose.
Croatian: Karakteristika rezistentnih bakterija je modifikacija fosfatnih skupina lipopolisaharida, koje se zamjenjuju etanolaminom ili aminoarabinozom.
English: Do not swallow Colobreathe capsules.
Croatian: Nemojte progutati kapsule Colobreathe.
English: • Inhaled bronchodilators
Croatian: • Inhalacijski bronhodilatatori
English: The Marketing Authorisation Holder shall agree the format and content of the healthcare professional and patient educational pack with the National Competent Authority prior to launch in the Member State.
Croatian: Nositelj odobrenja će dogovoriti oblik i sadržaj edukacijskog materijala za zdravstvenog radnika i bolesnika s nadležnim državnim tijelom prije stavljanja lijeka u promet u državi članici.
English: In embryo-fetal development studies in mice, resorptions and reduced ossification were seen, and in rats reduced fetal weights, reduced ossification and at the high dose of 10 mg colistin base per day, reduced post-natal survival.
Croatian: U ispitivanjima razvoja embrija/ploda u miševa, opažene su resorpcija i smanjeno okoštavanje, a u štakora smanjena tjelesna masa ploda, smanjeno okoštavanje i, pri visokoj dozi od 10 mg kolistina dnevno, smanjeno postnatalno preživljenje.
English: There were no notable effects on fertility or general reproductive performance in male or female rats or mice.
Croatian: Nisu opaženi učinci na plodnost ili općenitu reproduktivnu sposobnost u mužjaka ili ženki štakora i miševa.
English: There is no information about the safety of Colobreathe in pregnant women.
Croatian: Nema podataka o sigurnosti lijeka Colobreathe u trudnica.
English: After each inhalation of Colobreathe, the mouth should be rinsed with water.
Croatian: Nakon svakog udisanja lijeka Colobreathe, usta treba isprati vodom.
English: • “Physician DVD” information in “leaflet form” for those physicians who do not have access to a
Croatian: • Podatke „DVD za liječnika“ u „obliku uputa" za liječnike koji nemaju pristup čitaču DVD-a
English: What Colobreathe looks like and contents of the pack
Croatian: Kako Colobreathe izgleda i sadržaj pakiranja
English: An embryo-fetal study in rabbits reported no effects at intravenous doses up to 80 mg/kg colistimethate sodium (32 mg colistin base/kg).
Croatian: Ispitivanje embrija/ploda u kunića nije pokazalo učinaka pri intravenskim dozama do 80 mg/kg kolistimetatnatrija (32 mg kolistina/kg).
English: • The “Patient DVD”
Croatian: • „DVD za bolesnika“
English: Other medicines and Colobreathe
Croatian: Drugi lijekovi i Colobreathe
English: As you breathe in slowly, you suck air through the body of the Turbospin inhaler into the capsule chamber.
Croatian: Dok polako udišete, usisavate zrak kroz tijelo inhalatora Turbospin u komoricu kapsule.
English: Inhalation may induce coughing or bronchospasm which may be controlled by pre-treatment with inhaled beta2 agonists.
Croatian: Inhaliranje može izazvati kašalj ili bronhospazam, koji se mogu nadzirati prethodnim liječenjem inhalacijom beta2 agonista.
English: You can check whether the capsule is empty by unscrewing the mouthpiece and checking the capsule.
Croatian: 12. Možete provjeriti je li kapsula prazna tako da odvijete nastavak za usta i pregledate kapsulu.
English: • Introduction to the product: provide information on the contents of the box ie that 28 days treatment is 56 capsules and 1 device.
Croatian: • Predstavljanje lijeka: podaci o sadržaju kutije, tj. da se za 28-dnevno liječenje u kutiji nalazi 56
English: • Raised temperature
Croatian: • povišena tjelesna temperatura.
English: Colistimethate sodium (CMS) is a cyclic polypeptide antibacterial active substance that is derived from Bacillus polymyxa var. colistinus and belongs to the polymyxin group.
Croatian: Kolistimetatnatrij (KMN) je ciklična polipeptidna antibakterijska djelatna tvar koja se dobiva iz Bacillus polymyxa var. colistinus te pripada skupini polimiksina.
English: Safety and efficacy have been assessed in controlled studies for up to 24 weeks.
Croatian: Sigurnost i djelotvornost procijenjene su u kontroliranim ispitivanjima, koja su trajala do 24 tjedna (vidjeti dio 5.1).
English: Efficacy was measured by the change in FEV1 % predicted compared to baseline after a 24-week treatment period.
Croatian: Djelotvornost je izmjerena na temelju promjene očekivane vrijednosti FEV1 % u usporedbi s početnom vrijednošću nakon 24-tjednog razdoblja liječenja.
English: To pierce the capsule:
Croatian: Za probijanje kapsule:
English: Measures to increase the rate of elimination of colistimethate sodium e.g. mannitol diuresis, prolonged haemodialysis or peritoneal dialysis may be tried, but effectiveness is unknown.
Croatian: Može se pokušati mjerama za povećavanje brzine izlučivanja kolistimetatnatrija, npr. diurezom s manitolom, produženom hemodijalizom ili peritonealnom dijalizom, ali učinkovitost nije poznata.
English: Colobreathe contains colistimethate sodium, a type of antibiotic called a polymyxin.
Croatian: Colobreathe sadrži kolistimetatnatrij, vrstu antibiotika koji se naziva polimiksin.
English: The number of these side-effects may reduce as you continue to use the inhaler or your doctor may prescribe a bronchodilator to use before or after taking Colobreathe.
Croatian: Broj tih nuspojava može se smanjiti nastavkom uporabe inhalatora, a liječnik Vam može također propisati bronhodilatator, koji se primjenjuje prije ili nakon uzimanja lijeka Colobreathe.
English: The use of colistimethate sodium in patients with clinically significant haemoptysis should be undertaken or continued only if the benefits of treatment are considered to outweigh the risks of inducing further haemorrhage.
Croatian: Primjena kolistimetatnatrija u bolesnika s klinički značajnom hemoptizom smije se započeti ili nastaviti samo ako se smatra da su koristi liječenja veće od rizika izazivanja ponovnog krvarenja.
English: Single dose intravenous studies in human pregnancy show that colistimethate sodium crosses the placenta and consequently there is potential for foetal toxicity if administered during pregnancy.
Croatian: Ispitivanja jednokratne intravenske doze u trudnica pokazala su da kolistimetatnatrij prolazi kroz placentu, stoga može biti toksičan za plod ako se primjenjuje tijekom trudnoće.
English: Piercing the capsule and inhaling the medicine
Croatian: Probijanje kapsule i udisanje lijeka
English: Haemoptysis is a complication in cystic fibrosis and is more frequent in adults.
Croatian: Hemoptiza je komplikacija cistične fibroze i češća je u odraslih.
English: If the capsule cannot be loosened and the powder cannot be inhaled, dispose of the broken capsule and any powder remaining in it and use another.
Croatian: Ako ne možete osloboditi kapsulu i udahnuti prašak, bacite slomljenu kapsulu i sav preostali prašak u njoj i primijenite drugu.
English: When AUC 0-6 was adjusted by dose and body weight, a slightly higher AUC 0-6 /D/W for total CMS and total free colistin was observed in children.
Croatian: Kada je AUC 0-6 prilagođen prema dozi i tjelesnoj težini, u djece je opažen nešto viši AUC 0-6 /D/W za ukupni KMN i ukupni slobodni kolistin.
English: The capsules are contained in oPA/aluminium/pvc blisters with a peelable lidding foil composed of polyester/aluminium of either 8 or 14 hard capsules in each blister.
Croatian: Kapsule su sadržane u oPA/aluminij/PVC blisterima s odvojivom zaštitnom folijom od poliestera/aluminija sa 8 ili 14 tvrdih kapsula u jednom blisteru.
English: These reactions usually disappear or significantly diminish with continued use and may be ameliorated by appropriate treatment with beta2agonists prior to or following dry powder colistimethate sodium inhalation.
Croatian: Te reakcije obično nestaju ili se značajno smanjuju s nastavkom primjene ili primjerenim liječenjem beta2 agonistima prije ili nakon inhalacije suhog praška kolistimetatnatrija.
English: Taking these at the same time as Colobreathe may cause problems with muscle weakness;
Croatian: Istodobno uzimanje tih lijekova s lijekom Colobreathe može prouzročiti tegobe s mišićnom slabosti;
English: − that cough decreases with repeated use of the product and should stabilize after the first month or so.
Croatian: − se kašalj smanjuje s ponavljajućom primjenom lijeka i da se stabilizira približno nakon mjesec dana.
English: The most commonly reported adverse reactions as a percent of Colobreathe treated patients were: cough (55%), unpleasant taste (51%), throat irritation (34%), dyspnoea (10%) and dysphonia (10%).
Croatian: Pri liječenju lijekom Colobreathe, najčešće prijavljivane nuspojave, izražene u postocima, bile su: kašalj (55%), neugodan okus (51%), nadražaj grla (34%), dispneja (10%) i disfonija (10%).
English: • if you/your child suffer from myasthenia gravis and are taking macrolide type antibiotics such as azithromycin and clarithromycin, or fluoroquinolones such as norfloxacin and ciprofloxacin.
Croatian: • ako Vi/Vaše dijete imate bolest koja se naziva miastenija gravis i uzimate makrolidne antibiotike, kao što su azitromicin i klaritromicin, ili fluorokinolone, kao što su norfloksacin i ciprofloksacin.
English: If this occurs, you can loosen the capsule by gently tapping the chamber of the inhaler.
Croatian: Ako se to dogodi, kapsulu možete osloboditi laganim tapkanjem po komorici inhalatora.
English: Skin rash may also indicate hypersensitivity and if this occurs treatment should be withdrawn.
Croatian: Osip kože može također ukazivati na preosjetljivost i, ako se pojavi, liječenje se mora prekinuti.
English: Caution should be taken with concomitant use of colistimethate sodium and potential nephrotoxic or neurotoxic medicinal products, including non-depolarising muscle relaxants (see section 4.5).
Croatian: Potreban je oprez kada se kolistimetatnatrij primjenjuje istodobno kad i potencijalno nefrotoksični ili neurotoksični lijekovi, uključujući nedepolarizirajuće mišićne relaksanse (vidjeti dio 4.5).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Colobreathe in one or more subsets of the paediatric population in Pseudomonas aeruginosa pulmonary infection/colonisation in patients with cystic fibrosis (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka Colobreathe u jednoj ili više podskupina pedijatrijske populacije za bolesnike s cističnom fibrozom s plućnom infekcijom/kolonizacijom s Pseudomonas aeruginosa (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Colobreathe can only be administered using this device.
Croatian: Colobreathe se smije primjenjivati samo koristeći taj uređaj.
English: Now replace the mouthpiece by screwing it back into place.
Croatian: Sada vratite nastavak za usta i zavijte ga na svoje mjesto.
English: Do not swallow the capsules.
Croatian: Ne gutati kapsule.
English: Based on the safety profile of colistimethate sodium, neurotoxity may occur with the possibility of dizziness, confusion or visual disturbances.
Croatian: Na temelju sigurnosnog profila kolistimetatnatrija, može se pojaviti neurotoksičnost uz moguću omaglicu, konfuziju ili smetnje vida.
English: Pseudomonas aeruginosa is a very common bacterium that infects nearly all cystic fibrosis patients at some time during their lives.
Croatian: Pseudomonas aeruginosa je vrlo česta bakterija koja jednom u životu zarazi skoro svakog bolesnika s cističnom fibrozom.
English: If you/your child has any problems with your kidneys or nerves, care should be taken when administering Colobreathe but your doctor should be aware of this.
Croatian: Ako Vi/Vaše dijete imate bilo kakvih problema s bubrezima ili živcima, potreban je oprez prilikom primjene lijeka Colobreathe, a Vaš liječnik treba biti upoznat s time.
English: Concomitant use of inhaled colistimethate sodium with other medicinal products that are potentially nephrotoxic or neurotoxic, such as aminoglycosides, or neuromuscular blocking products, such as curariform agents should be undertaken with caution.
Croatian: Istodobnu primjenu inhaliranog kolistimetatnatrija s drugim lijekovima koji mogu biti nefrotoksični ili neurotoksični, kao što su aminoglikozidi, ili neuromišićni blokatori poput kurarimimetičkih lijekova treba započeti uz oprez.
English: • Blockage in the ears
Croatian: • začepljene uši
English: • if you/your child are allergic to colistimethate sodium, colistin sulphate or polymyxins.
Croatian: • ako ste Vi/Vaše dijete alergični na kolistimetatnatrij, kolistinsulfat ili polimiksine.
English: Gently insert the capsule into the chamber with the widest end first.
Croatian: Kapsulu nježno stavite u komoricu prvo sa širim krajem.
English: Rinsing may reduce the risk of developing oral fungal super-infection during treatment and may also reduce the unpleasant taste associated with colistimethate sodium.
Croatian: Ispiranje može smanjiti rizik od nastanka oralne gljivične superinfkecije tijekom liječenja i može također smanjiti neugodan okus povezan uz kolistimetatnatrij.
English: If you/your child forget to take a dose of Colobreathe then you/your child should take your missed dose as soon as you/your child remember.
Croatian: Ako Vi/Vaše dijete zaboravite uzeti dozu lijeka Colobreathe, uzmite (Vi/Vaše dijete) propuštenu dozu čim se sjetite.
English: Cross resistance between colistimethate sodium and polymyxin B is expected.
Croatian: Očekuje se križna rezistencija između kolistimetatnatrija i polimiksina B.
English: Bronchospasm and coughing
Croatian: Bronhospazam i kašljanje
English: Remove a single capsule from the blister pack.
Croatian: Izvadite jednu kapsulu iz blister pakiranja.
English: Although the population PK analysis showed that age is a statistically significant covariate, the AUC 0-6 and dose adjusted AUC0-6 (AUC 0-6 /D) for total CMS and total free colistin were similar between children and adolescents, while higher AUC 0-6 was observed in the adult group.
Croatian: Iako je populacijska farmakokinetička analiza pokazala da je dob statistički značajna kovarijabla, AUC 0-6 i AUC0-6 prilagođen za dozu (AUC 0-6 /D) za ukupni KMN i ukupni slobodni kolistin bili su slični kod djece i adolescenata,
English: You may see a small amount of powder released from the capsule chamber after the capsule is pierced, this is normal.
Croatian: Možda ćete vidjeti malu količinu praška ispuštenu iz komorice nakon probijanja kapsule.
English: Hypersensitivity to the active substance, colistin sulphate or polymyxin B.
Croatian: Preosjetljivost na djelatnu tvar, kolistinsulfat ili polimiksin B.
English: If you/your child accidentally peel back the foil, and any capsules become exposed, please discard these capsules.
Croatian: Ako Vi/Vaše dijete nehotično odvojite foliju tako da su kapsule izložene zraku, te kapsule bacite.
English: If you/your child have any further questions on the use of this medicine, ask your doctor.
Croatian: Ako Vi/Vaše dijete imate dodatnih pitanja o primjeni lijeka, posavjetujte se s liječnikom.
English: Colistimethate is not significantly absorbed from the lung after inhalation of Colobreathe.
Croatian: Kolistimetat se ne apsorbira značajno iz pluća nakon inhaliranja lijeka Colobreathe.
English: Colobreathe should be used with extreme caution in patients with myasthenia gravis because of potential for drug induced neuromuscular blockade.
Croatian: Colobreathe treba primjenjivati uz krajnji oprez u bolesnika s miastenijom gravis zbog moguće neuromuskularne blokade prouzročene lijekom.
English: The most commonly reported adverse reactions as a percent of all Colobreathe treated patients were: unpleasant taste (62%), cough (59.4%), throat irritation (43.9%), dyspnoea (16.6%) and dysphonia (10.7%).
Croatian: Pri liječenju lijekom Colobreathe, u svih bolesnika, najčešće prijavljivane nuspojave, izražene u postocima, bile su: neugodan okus (62%), kašalj (59,4%), nadražaj grla (43,9%), dispneja (16,6%) i disfonija (10,7%).
English: If acute respiratory exacerbations develop additional intravenous or oral antibacterial agent therapy should be considered.
Croatian: Ako se razvije akutna respiratorna egzacerbacija, potrebno je razmotriti davanje dodatnih intravenskih ili peroralnih antibakterijskih lijekova.
English: After administration of 1,662, 500IU twice daily for 7 days in adult, adolescent and paediatric cystic fibrosis patients mean C max values of total colistimethate of up to 455ng/ml (adult mean) were observed.
Croatian: Colobreathe 1 662 500 IU dvaput na dan tijekom 7 dana u odraslih, adolescenata i djece s cističnom fibrozom, zabilježene su prosječne vrijednosti C max ukupnog kolistimetata do 455 ng/ml (prosjek u odraslih).
English: For inhalation use only.
Croatian: Samo za primjenu inhalacijom.
English: If you/your child forget to use Colobreathe
Croatian: Ako ste Vi/Vaše dijete zaboravili primijeniti Colobreathe
English: Carry on from there as instructed.
Croatian: Nakon toga, nastavite prema uputama.
English: Warnings and precautions Tell your doctor if you/your child has ever had any of the following conditions:
Croatian: Obavijestite liječnika ako ste Vi/Vaše dijete ikada imali jedno od sljedećeg:
English: • if you/your child are taking aminoglycoside antibiotics used to treat infections caution must be taken;
Croatian: • ako Vi/Vaše dijete uzimate aminoglikozidne antibiotike koji se koriste za liječenje infekcija nužan je oprez;
English: Absorption of colistimethate from the gastro-intestinal tract does not occur to any appreciable extent in the normal individual.
Croatian: Apsorpcija kolistimetata iz gastrointestinalnog trakta u zdravih osoba ne događa se u značajnom opsegu.
English: Colistimethate sodium should be used with extreme caution in patients with porphyria.
Croatian: Kolistimetatnatrij je potrebno primjenjivati uz krajnji oprez u bolesnika s porfirijom.
English: Colobreathe is used to control persistent lung infections caused by the bacterium Pseudomonas aeruginosa in adult patients and children aged 6 years and older with cystic fibrosis.
Croatian: Colobreathe se koristi za kontrolu ustrajne plućne infekcije prouzročene bakterijom Pseudomonas aeruginosa u odraslih bolesnika, i djece u dobi od 6 godina i starijih, s cističnom fibrozom.
English: Forced expiratory volume decreased
Croatian: Smanjeni forsirani ekspiratorni volumen
English: − emphasise that patients should persist with the treatment.
Croatian: − naglasak da bolesnik mora nastaviti s liječenjem
English: Currently there is no experience of overdose with the use of Colobreathe.
Croatian: Trenutno nema iskustva s predoziranjem prilikom primjene lijeka Colobreathe.
English: Overdose is unlikely by the inhaled route but has been recognised after systemic use.
Croatian: Predoziranje nije vjerojatno prilikom primjene lijekova inhaliranjem, ali je potvrđeno pri sistemskoj primjeni.
English: • The contents of one Colobreathe capsule should be inhaled twice a day using the Turbospin inhaler.
Croatian: • Sadržaj jedne kapsule lijeka Colobreathe mora se udisati dvaput na dan inhalatorom Turbospin.
English: There is no experience of using Colobreathe concurrently with other inhaled antibacterial agents.
Croatian: Nema iskustva s primjenom lijeka Colobreathe istodobno s drugim inhaliranim antibakterijskim lijekovima.
English: Do not use this medicine after the expiry date, which is stated on the outer carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza „Rok valjanosti“.