natgillin/translations-raw huggingface dataset:
The safety of Colobreathe has been assessed in a total of 237 subjects (225 cystic fibrosis patients and 12 healthy volunteers).
Varnost zdravila Colobreathe so ocenili pri skupaj 237 osebah (225 bolnikov s cistično fibrozo in 12
• The capsule shell is made of gelatin, which is harmless to humans if swallowed or inhaled.
• Ovoj kapsule je izdelan iz želatine, ki ljudem ne škoduje, če jo zaužijejo ali vdihnejo.
• Raised temperature
• povišana telesna temperatura.
The adjusted treatment difference and 95% confidence interval have been back transformed from log transformed data.
Vrednosti rezultatov, tj. razlike prilagojenega zdravljenja in 95-odstotnega intervala zaupanja, so bile transformirane nazaj iz poprej logaritmiranih vrednosti.
If any of these effects become a problem, please contact your doctor who may change your treatment.
Če se kateri koli učinek razvije v težavo, se posvetuje s svojim zdravnikom, ki bo morda način zdravljenja spremenil.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http:/www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
Remove the Turbospin inhaler from your mouth and hold your breath for about 10 seconds or for as long as is comfortable, then breathe out slowly.
Inhalator Turbospin vzemite iz ust in zadržite dih za približno 10 sekund ali dokler ga lahko zadržite brez težav.
More common signs and symptoms of intravenous overdose include unsteadiness, paraesthesia and dizziness.
Več znakov in simptomov intravenskega prevelikega odmerjanja vključuje nestabilnost, parestezijo in omotico.
Do not give Colobreathe to children under the age of 6 years as it is not suitable for them.
Otrokom, starim manj kot 6 let, ne dajajte zdravila Colobreathe, saj zanje ni primerno.
• Lack of energy, tiredness
• pomanjkanje energije, utrujenost,
If you/your child have any further questions on the use of this medicine, ask your doctor.
Če imate vi/vaš otrok dodatna vprašanja o uporabi zdravila, se posvetujte s svojim zdravnikom.
Your doctor, pharmacist or nurse should show you/your child how to inhale the medicine when you/your child first start treatment:
Vaš zdravnik, farmacevt ali medicinska sestra naj vam/vašemu otroku ob začetku zdravljenja pokaže, kako se zdravilo inhalira:
As 80% of a parenteral dose can be recovered unchanged in the urine, and there is no biliary excretion, it can be assumed that the remaining drug is inactivated in the tissues.
Ker se 80 % parenteralnega odmerka v nespremenjeni obliki pojavi v urinu in ker ni izločanja skozi žolč, je mogoče predvidevati, da se preostanek zdravila v tkivu deaktivira.
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.
Uporaba natrijevega kolistimetata pri bolnikih s klinično pomembno hemoptizo naj se začne ali nadaljuje le, če se ocenjuje, da so koristi zdravljenja večje od tveganja za ponovno krvavitev.
Animal studies of safety pharmacology, repeated dose toxicity or toxicity to reproduction, employing routes assuring systemic exposure, showed no particular hazard.
Študije farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih ali vpliva na sposobnost razmnoževanja pri živalih z načinom dajanja, ki zagotavlja sistemsko izpostavljenost, ne kažejo posebnega tveganja za človeka.
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.
Pri sočasni uporabi z drugimi formulacijami natrijevega kolistimetata je potrebna previdnost, saj je izkušenj malo in obstaja možnost sumativne toksičnosti.
• Difficulty in breathing
• težave z dihanjem,
Occasionally, very small pieces of the capsule shell can get into your mouth or airways.
Občasno lahko zelo majhni delci ovoja kapsule zaidejo v vaša usta ali dihalne poti.
The epidemiological cut off value for colistimethate sodium for Pseudomonas aeruginosa, distinguishing the wild type population from isolates with acquired resistance traits, is 4 mg/l.
Epidemiološka mejna vrednost za Pseudomonas aeruginosa, s katero se populacija divje vrste razlikuje od izolatov s pridobljeno odpornostjo, je 4 mg/ml.
Inhalation powder, hard capsule.
prašek za inhaliranje, trda kapsula
Polymyxins persist in the liver, kidney, brain, heart and muscle.
Polimiksini se ohranijo v jetrih, ledvicah, možganih, srcu in mišicah.
Like all medicines this medicine can cause side effects, although not everyone gets them.
Možni neželeni učinki Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
One study in cystic fibrosis patients gives the steady-state volume of distribution as 0.09 l/kg.
Ena študija bolnikov s cistično fibrozo navaja porazdelitev v stanju dinamičnega ravnovesja 0,09 l/kg.
Colistimethate sodium should be used with extreme caution in patients with porphyria.
Natrijev kolistimetat je treba uporabljati izredno previdno pri bolnikih s porfirijo.
Take care not to cover the air slits with your fingers or mouth during inhalation.
Med vdihavanjem pazite, da ne boste s prsti ali usti prekrili zračnih rež.
The above side effects have been seen in people of all ages with similar frequency.
Zgornji neželeni učinki so se pojavili pri vseh bolnikih s podobno pogostnostjo.
Please discuss the use of Colobreathe with your doctor.
O uporabi zdravila Colobreathe se posvetujte s svojim zdravnikom.
Taking these at the same time as Colobreathe may cause problems with muscle weakness;
Sočasno jemanje teh zdravil z zdravilom Colobreathe lahko povzroči težave z mišično oslabelostjo;
• The capsule is now pierced and the contents can be inhaled.
• Kapsula je tako prebodena in lahko vdihnete njeno vsebino.
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.
V študiji razvoja embria/zarodka pri miših so opazili resorpcijo in zmanjšano okostenitev, pri podganah pa zmanjšano telesno maso zarodka, zmanjšano okostenitev in pri visokih odmerkih 10 mg kolistina na dan, zmanjšano preživetje po rojstvu.
The safety and efficacy of Colobreathe in children under 6 years of age have not been established.
Pediatrična populacija Varnost in učinkovitost zdravila Colobreathe pri otrocih, starih manj kot 6 let, še nista bili dokazani.
A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from colistimethate sodium therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z natrijevim kolistimetatom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
Once you have removed the capsule it must be used immediately.
Odstranjeno kapsulo morate uporabiti takoj.
Nephrotoxicity/neurotoxicity
Nefrotoksičnost/nevrotoksičnost
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use Colobreathe are provided with a healthcare professional and patient educational pack containing the following:
Imetnik dovoljenja za promet z zdravilom mora poskrbeti, da bodo vsi zdravniki, ki bodo predpisovali zdravilo Colobreathe, prejeli paket izobraževalnega gradiva za zdravstvene delavce in navodila za bolnike, ki vsebuje:
Overdose can also cause acute renal failure characterised by decreased urine output and increased serum concentrations of BUN and creatinine.
Preveliko odmerjanje lahko povzroči tudi akutno ledvično odpoved, za katero je značilno manjše izločanje urina in povečanje koncentracij BUN in kreatinina v serumu.
Naturally resistant Gram-negative bacteria, such as Proteus mirabilis and Burkholderia cepacia, show complete substitution of their lipid phosphate by ethanolamine or aminoarabinose.
Naravno odporne po Gramu negativne bakterije, kot sta Proteus mirabilis in Burkholderia cepacia, kažejo celovito zamenjavo svojih lipidnih fosfatov z etanolaminom ali aminoarabinozo.
The estimated mean terminal half-lives for total CMS and total free colistin were 3.0 and 6.4 h, respectively.
Srednji ocenjeni končni razpolovni čas celotnega natrijevega kolistimetata in celotnega prostega kolistina je bil 3,0 oziroma 6,4 h.
Some detail about cleaning the Turbospin device.
Nekaj podrobnosti o čiščenju pripomočka Turbospin.
Piercing the capsule and inhaling the medicine
Prebadanje kapsule in inhaliranje zdravila
Pharmacotherapeutic group: antibacterials for systemic use, other antibacterials.
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje bakterijskih infekcij, druga protibakterijska zdravila.
• The “Patient DVD”
• »DVD za bolnika«.
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.
Natrijev kolistimetat in kolistin so raziskali in vitro, da bi ugotovili učinke na ekspresijo encimov citokroma P450 (CYP) z obdelavo primarnih kultur svežih humanih hepatocitov.
Store in the original package until immediately before use in order to protect from moisture.
Shranjujte v originalni ovojnini do tik pred uporabo, da zagotovitev zaščite pred vlago.
Polymyxins are selective for Gram-negative bacteria that have a hydrophobic outer membrane.
Polimiksini so selektivni za po Gramu negativne bakterije, ki imajo hidrofobno zunanjo membrano.
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.
Kapsule so pakirane v pretisnih omotih iz oPA/aluminija/PVC s pokrovom iz odluščljive folije iz poliestra/aluminija, ki vsebujejo po 8 ali 14 trdih kapsul v vsakem pretisnem omotu.
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.
Študije enkratnega intravenskega odmerka pri nosečnicah kažejo, da natrijev kolistimetat prehaja skozi placento, zato obstaja možnost toksičnosti za plod, če se daje med nosečnostjo.
• Changes in how your lungs function (found by testing)
• spremembe v delovanju pljuč (ugotovijo se s testiranjem),
Studies in animals using parenteral administration have shown reproductive toxicity (see section 5.3).
Študije na živalih s parenteralnim dajanjem so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
• “Physician DVD” information in “leaflet form” for those physicians who do not have access to a
• Podatke »DVD za zdravnika« v »obliki brošure z navodili« za zdravnike, ki nimajo dostopa do predvajalnika DVD
Change in FEV1 (% predicted) from baseline at Week 24 (ITT Population) Patient group Colobreathe
Sprememba vrednosti FEV1 (napovedani odstotki) od izhodišča v 24. tednu (populacija ITT) Skupina bolnikov
Inhale the medicine again by repeating Steps 7 and 8 to ensure you have emptied the capsule.
Še enkrat vdihnite zdravilo tako, da ponovite koraka 7 in 8.
What Colobreathe is and what it is used for What you need to know before you use Colobreathe How to use Colobreathe
Kaj je zdravilo Colobreathe in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Colobreathe Kako uporabljati zdravilo Colobreathe
Bronchospasm and coughing
Bronhospazem in kašljanje
Your doctor should advise you before using Colobreathe whether the benefits of the medicine exceed the risks.
Vaš zdravnik vam mora pred začetkom uporabe zdravila Colobreathe vedno svetovati, ali so koristi zdravila večje kot z njim povezana tveganja.
Overdose is unlikely by the inhaled route but has been recognised after systemic use.
Preveliko odmerjanje ni verjetno pri uporabi zdravila z inhaliranjem, vendar je bilo potrjeno pri sistemski uporabi.
Inhalation may induce coughing or bronchospasm which may be controlled by pre-treatment with inhaled beta2 agonists.
Inhaliranje lahko spodbudi kašelj ali bronhospazem, ki ju lahko nadzirate s predhodnim zdravljenjem z inhaliranjem agonistov beta2.
An embryo-fetal study in rabbits reported no effects at intravenous doses up to 80 mg/kg colistimethate sodium (32 mg colistin base/kg).
Študija embria/zarodka pri kuncih ni pokazala učinkov pri intravenskih odmerkih do 80 mg/kg natrijevega kolistimetata (32 mg kolistina/kg).
After each inhalation of Colobreathe, the mouth should be rinsed with water.
Po vsakem inhaliranju zdravila Colobreathe je treba usta izprati z vodo.
You/your child may get an unpleasant taste in your mouth after inhaling Colobreathe.
Pri vas/vašem otroku se lahko pojavi neprijeten občutek v ustih po inhaliranju zdravila Colobreathe.
The following instructions should be adhered to by the patient when taking Colobreathe:
Bolnik mora pri uporabi zdravila Colobreathe upoštevati naslednja navodila:
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.
Število teh neželenih učinkov se lahko z nadaljevanjem uporabe inhalatorja zmanjša, vaš zdravnik pa lahko predpiše tudi bronhodilatator, ki se uporabi pred uporabo zdravila Colobreathe ali po njej.
• blood in your sputum (the substance you cough up)
• kri v izbljuvku (snov, ki jo izkašljate)
Resistant bacteria are characterised by modification of the phosphate groups of lipopolysaccharide, which become substituted with ethanolamine or aminoarabinose.
Za rezistentne bakterije je značilno preoblikovanje fosfatnih skupin lipopolisaharidov, ki jih zamenja etanolamin ali aminoarabinoza.
Pseudomonas aeruginosa is a very common bacterium that infects nearly all cystic fibrosis patients at some time during their lives.
Pseudomonas aeruginosa je zelo pogosta bakterija, ki enkrat v življenju okuži skoraj vsakega bolnika s cistično fibrozo.
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.
Klinična učinkovitost Klinična študija faze 3 je bila randomizirana odprta študija z aktivno primerjavo, v kateri so primerjali učinkovitost 1.662.500 i.e. suhega praška za inhaliranje natrijevega kolistimetata s 300 mg/5 ml raztopine tobramicina v nebulatorju pri 380 osebah z dokumentirano cistično fibrozo in zapletom zaradi kronične pljučne okužbe z bakterijo Pseudomonas aeruginosa.
• Unusual noises in the chest (your doctor would hear this when listening to your lungs with a stethoscope)
• neobičajni šumi v prsnem košu (sliši jih vaš zdravnik, ko pljuča posluša s stetoskopom),
If you/your child experience signs of an allergic reaction you should seek urgent medical attention.
Če se pri vas/vašem otroku pojavi alergijska reakcija, poiščite nujno medicinsko pomoč.
Use as directed by the physician.
Uporabljajte po navodilih zdravnika.
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.
Poskusite lahko z ukrepi za povečanje hitrosti izločanja natrijevega kolistimetata, kot so npr. diureza z manitolom, podaljšana hemodializa ali peritonealna dializa, vendar učinkovitost ni znana.
Once all the contents have been inhaled, rinse your mouth out well with water and spit out.
Ko vdihnete vso vsebino, si usta dobro izperite z vodo, ki jo nato izpljunite.
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.
Te reakcije običajno izginejo ali se značilno zmanjšajo z nadaljevanjem uporabe, mogoče pa jih je tudi ublažiti z ustreznim zdravljenjem z agonisti beta2 pred inhaliranjem suhega praška z natrijevim kolistimetatom ali po njem.
Your doctor will decide how long you/your child's treatment should last.
kako dolgo naj traja zdravljenje za vas/vašega otroka.
Tell your doctor if you/your child are taking, have recently taken or might use any other medicines, and in particular:
Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo.
• 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.
• če imate vi ali vaš otrok miastenijo gravis in jemljete makrolidne antibiotike, kot sta azitromicin in klaritromicin, ali fluorokinolone, kot sta norfloksacin in ciprofloksacin.
If acute respiratory exacerbations develop additional intravenous or oral antibacterial agent therapy should be considered.
Če se razvije akutno respiratorno poslabšanje, je treba premisliti o dajanju dodatnih intravenskih ali peroralnih protibakterijskih zdravil.
When the capsule is empty, unscrew the mouthpiece, then remove and discard the empty capsule.
Ko je kapsula prazna, odvijte ustnik ter odstranite in zavrzite prazno kapsulo.
Haemoptysis is a complication in cystic fibrosis and is more frequent in adults.
Hemoptiza je zaplet pri cistični fibrozi, ki je bolj običajen pri odraslih.
• Blockage in the ears
• zaspanost, • blokada v ušesih,
Colobreathe should be used with extreme caution in patients with myasthenia gravis because of potential for drug induced neuromuscular blockade.
Zdravilo Colobreathe je treba uporabljati izredno previdno pri bolnikih z miastenijo gravis zaradi možne živčno-mišične blokade, ki jo povzroči zdravilo.
Explanation of the Turbospin and how it works.
Turbospin in njegovem delovanju.
• if you/your child are allergic to colistimethate sodium, colistin sulphate or polymyxins.
• če ste vi/vaš otrok alergični na natrijev kolistimetat, kolistinijev sulfat ali polimiksine.
Rinsing may reduce the risk of developing oral fungal super-infection during treatment and may also reduce the unpleasant taste associated with colistimethate sodium.
Izpiranje lahko zmanjša nevarnost nastanka ustne glivične superinfekcije med zdravljenjem, prav tako pa lahko zmanjša neprijeten okus, povezan s natrijevim kolistimetatom.
Very common: may affect more than 1 in 10 people
Zelo pogosti: pojavijo se lahko pri več kot 1 bolniku od 10 bolnikov
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.
Če se kapsule ne da sprostiti in vdihavanje praška ni mogoče, zavrzite prelomljeno kapsulo skupaj s preostalim praškom in uporabite drugo.
Gently insert the capsule into the chamber with the widest end first.
Previdno vstavite kapsulo v komoro, s širšim delom naprej.
If you/your child accidentally peel back the foil, and any capsules become exposed, please discard these capsules.
Če vi/vaš otrok nehote odluščite folijo tako, da so kapsule izpostavljene zraku, te kapsule zavrzite.
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%).
Pri zdravljenju z zdravilom Colobreathe so pri vseh bolnikih najpogosteje poročali o naslednjih neželenih učinkih, izraženih v odstotkih: neprijeten okus (62 %), kašelj (59,4 %), draženje grla, (43,9 %), dispneja (16,6 %) in disfonija (10,7 %).
What Colobreathe is and what it is used for
Kaj je zdravilo Colobreathe in za kaj ga uporabljamo
• Hold the inhaler with the mouthpiece upright, gently push the piston upwards until the visible line is reached - you will feel resistance at this point and this will lock the capsule in place ready for piercing.
Nežno potisnite bat navzgor, dokler ne dosežete natisnjene črte - začutili boste upor, kapsula pa se bo zaskočila na mesto, tako da bo pripravljena na prebod.
All subjects were also required to have successfully completed a minimum of two cycles of nebulised tobramycin solution run-in prior to randomisation.
Vse osebe so morale pred randomizacijo uspešno končati uvajalno obdobje z vsaj dvema cikloma raztopine tobramicina v nebulatorju.
• Coughing up blood, wheezing, chest discomfort, asthma, productive cough (a cough which brings up mucus), infection of the lungs, lung crackles (your doctor would hear this when listening to your lungs using a stethoscope)
• izkašljevanje krvi, sopenje, nelagodje v prsnem košu, astma, produktiven kašelj (kašelj, pri katerem se izpljuva sluz), okužba pljuč, šumi na pljučih (sliši jih vaš zdravnik, ko pljuča posluša s stetoskopom),
To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler by a physician or other health professional, with the first dose being given under medical supervision.
Kapsule se ne smejo pogoltniti.Za zagotovitev pravilnega dajanja zdravila mora zdravnik ali drug zdravstveni delavec bolniku pokazati, kako uporabljati inhalator, pri čemer se prvi odmerek uporabi pod zdravniškim nadzorom.
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.
Čeprav je analiza populacijske farmakokinetike pokazala, da je starost statistično pomembna kovariata, so bile vrednosti AUC0-6 in popravljene vrednosti AUC0-6 glede na odmerek (AUC0-6/odmerek) za celotni natrijev kolistimetat in celotni prosti kolistin podobne pri otrocih in mladostnikih, medtem ko so v skupini odraslih opazili višjo vrednost AUC0-6.
Contents of the pack and other information What Colobreathe contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Colobreathe
Carry on from there as instructed.
Nadaljujte po navodilih.
• Thirst
• žeja.
What you need to know before you use Colobreathe Do not use Colobreathe:
Kaj morate vedeti, preden boste uporabili zdravilo Colobreathe Ne uporabljajte zdravila Colobreathe:
There is no information about the safety of Colobreathe in pregnant women.
Ni podatkov o uporabi zdravila Colobreathe pri nosečnicah.
No dose adjustment is considered to be necessary (see section 5.2).
Okvara ledvic Ocenjuje se, da odmerka ni treba prilagajati (glejte poglavje 5.2).
Colobreathe contains colistimethate sodium, a type of antibiotic called a polymyxin.
Zdravilo Colobreathe vsebuje natrijev kolistimetat, vrsto antibiotika, imenovanega polimiksin.
High PK variability was observed in all three groups.
V vseh treh skupinah so opazili veliko variabilnost farmakokinetičnih parametrov.
Based on the safety profile of colistimethate sodium, neurotoxity may occur with the possibility of dizziness, confusion or visual disturbances.
Na podlagi varnostnega profila natrijevega kolistimetata se lahko pojavi nevrotoksičnost z možno omotičnostjo, zmedenostjo ali motnjami vida.
If this occurs, you can loosen the capsule by gently tapping the chamber of the inhaler.
Če se to zgodi, jo lahko sprostite tako, da narahlo potrkate po komori inhalatorja.
There were no notable effects on fertility or general reproductive performance in male or female rats or mice.
Učinkov na plodnost ali splošno sposobnost razmnoževanja pri podganjih in mišjih samcih ali samicah niso opazili.
As you breathe in slowly, you suck air through the body of the Turbospin inhaler into the capsule chamber.
S počasnim vdihom potegnete zrak skozi telo inhalatorja Turbospin v komoro s kapsulo.