natgillin/translations-raw huggingface dataset:
Since the mechanism of action of the polymyxins is different from that of other antibacterial agents, resistance to colistin and polymyxin by the above mechanism alone would not be expected to result in resistance to other drug classes.
Pričakuje se navzkrižna rezistenca med natrijevim kolistimetatom in polimiksinom B. Ker se mehanizem delovanja polimiksinov razlikuje od tistega pri drugih protibakterijskih zdravilih, ni pričakovati, da bi odpornost na kolistin in polimiksin samo po zgornjem mehanizmu povzročila odpornost na druge razrede zdravil.
If you do not hear the capsule spinning, the capsule may be stuck in the compartment.
Če ne slišite, kako se kapsula vrti, to morda pomeni, da se je zataknila.
• Weight fluctuations, decreased appetite
• nihanje telesne mase, zmanjšanje apetita,
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.
Zdravilo Colobreathe se uporablja za nadzor trdovratnih okužb pljuč, ki jih povzroča bakterija Pseudomonas aeruginosa pri odraslih bolnikih in otrocih, starih 6 in več let, s cistično fibrozo.
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.
Po popravku vrednosti AUC 0-6 glede na odmerek in telesno maso so pri otrocih opazili nekoliko višjo vrednost AUC 0-6/odmerek/maso za celotni natrijev kolistimetat in celotni prosti kolistin.
Removing the empty capsule from the Turbospin
Odstranitev prazne kapsule iz inhalatorja Turbospin
• The “Physician DVD”
• »DVD za zdravnika«,
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).
Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom Colobreathe za vse skupine pediatrične populacije za bolnike s cistično fibrozo s pljučno okužbo/kolonizacijo s Pseudomonas aeruginosa (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Hypersensitivity to the active substance, colistin sulphate or polymyxin B.
Preobčutljivost na zdravilno učinkovino, kolistinijev sulfat ali polimiksin B.
• Diarrhoea, wind
• driska, vetrovi,
To inhale Colobreathe from the capsule through the Turbospin inhaler follow the procedure described below.
Za inhaliranje zdravila Colobreathe iz kapsule skozi inhalator Turbospin upoštevajte spodaj opisani postopek.
Do not use this medicine after the expiry date, which is stated on the outer carton and blister after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji škatli in pretisnem omotu poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
Colobreathe can only be administered using this device.
Zdravilo Colobreathe se lahko uporabi samo s tem pripomočkom.
8 capsules with 1 Turbospin inhaler (1 strip of 8 capsules) 56 capsules with 1 Turbospin inhaler (4 strips of 14 capsules) 56 capsules with 1 Turbospin inhaler (7 strips of 8 capsules)
8 kapsul z 1 inhalatorjem Turbospin (1 pretisni omot z 8 kapsulami) 56 kapsul z 1 inhalatorjem Turbospin (4 pretisni omoti s 14 kapsulami) 56 kapsul z 1 inhalatorjem Turbospin (7 pretisnih omotov z 8 kapsulami
• if you/your child need to have a general anaesthetic caution must be taken.
• če boste vi ali vaš otrok potrebovali splošno anestezijo, morate biti previdni.
Nonclinical data reveal no special hazard for humans based on conventional studies of genotoxicity.
Predklinični podatki na osnovi običajnih študij genotoksičnosti ne kažejo posebnega tveganja za človeka.
There were 32 patients aged 6-12 years, 41 patients aged 13-17 years and 114 patients aged 18 years and older.
Med njimi je bilo 187 bolnikov, starih 6 let ali več, izpostavljenih zdravilu Colobreathe ena kapsula dvakrat na dan v 24-tedenski primerjalni študiji faze 3. 32 bolnikov je bilo starih med 6 in 12 let, 41 bolnikov je bilo starih med 13 in 17 let in 114 bolnikov je bilo starih 18 let ali več.
Colistimethate sodium is not recommended during pregnancy and in women of childbearing potential not using contraception.
Natrijevega kolistimetata ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
Colistimethate sodium has no notable effects on fertility in male or female rats or mice.
Natrijev kolistimetat nima opaznih učinkov na plodnost pri podganjih in mišjih samcih ter samicah.
You/your child should confirm the order of your treatments with your doctor.
Za vas/vašega otroka naj vrstni red teh oblik zdravljenja potrdi zdravnik.
When you/your child start using Colobreathe, you/your child may find they have cough, breathlessness, tightness of chest or wheezing.
Ko začnete vi/vaš otrok uporabljati zdravilo Colobreathe, se lahko zgodi, da se razvije kašelj, oteženo dihanje, tiščanje v prsih ali sopenje.
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.
Pri sočasni uporabi inhaliranega natrijevega kolistimetata z drugimi potencialno nefrotoksičnimi ali nevrotoksičnimi zdravili, kot so aminoglikozidi, ali živčnomišični blokatorji, kot so kurariformne učinkovine, je potrebna previdnost.
• The contents of one Colobreathe capsule should be inhaled twice a day using the Turbospin inhaler.
• Vsebina ene kapsule zdravila Colobreathe se inhalira dvakrat na dan s pomočjo inhalatorja
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.
Po 7-dnevnem odmerjanju zdravila Colobreathe 1.662.500 i.e. dvakrat dnevno pri odraslih, mladostnikih in pediatričnih bolnikih s cistično fibrozo so opazili srednje vrednosti C max celotnega kolistimetata do 455 ng/ml (srednja vrednost pri odraslih).
Care should still be taken in administering Colobreathe to patients who are known to have a propensity for nephrotoxic or neurotoxic events.
Kljub temu je potrebna previdnost pri dajanju zdravila Colobreathe bolnikom z znano nagnjenostjo k nefrotoksičnim ali nevrotoksičnim dogodkom.
Subjects were randomised to receive either one 1,662,500 IU capsule of colistimethate sodium twice daily, or 300 mg of tobramycin, twice daily.
Osebe so bile randomizirane tako, da so dobivale bodisi eno kapsulo z 1.662.500 i.e. natrijevega kolistimetata dvakrat na dan bodisi 300 mg tobramicina dvakrat na dan.
Injury, poisoning and procedural complications
Poškodbe in zastrupitve in zapleti pri posegih napaka pri dajanju zdravil
If you/your child use more Colobreathe than you/your child should, or have accidentally swallowed the capsule, contact your doctor immediately for advice.
Če ste vi/vaš otrok uporabili večji odmerek zdravila Colobreathe, kot bi smeli, ali če ste kapsulo nehote pogoltnili, se takoj posvetujte s svojim zdravnikom.
Do not swallow Colobreathe capsules.
Kapsul Colobreathe ne zaužijte.
There is no experience of using Colobreathe concurrently with other inhaled antibacterial agents.
Izkušenj z uporabo zdravila Colobreathe sočasno z drugimi inhalacijskimi protibakterijskimi zdravili ni.
Currently there is no experience of overdose with the use of Colobreathe.
Simptomi Trenutno ni izkušenj s prevelikim odmerjanjem pri uporabi zdravila Colobreathe.
The Turbospin is an inspiratory flow driven dry powder inhaler made of polypropylene and stainless steel.
Pripomoček Turbospin je inhalator za suh prašek, narejen iz polipropilena in nerjavečega jekla, ki ga aktivira zračni tok vdihavanja.
Deeply press the piston a few times whilst keeping the chamber turned upside down.
Bat nekajkrat potisnite do konca, medtem ko držite komoro obrnjeno navzdol.
Colobreathe inhalation powder, hard capsule (inhalation powder) is supplied as small, hard, transparent gelatin capsules containing a fine white powder.
Zdravilo Colobreathe prašek za inhaliranje, trda kapsula (prašek za inhaliranje) je dobavljen v obliki majhnih, trdih, prozornih želatinskih kapsul, ki vsebujejo droben bel prašek.
All patients using LOCF
Vsi bolniki z uporabo metode zgodovinskih podatkov (LOCF - Last Observation Carried
EU/1/11/747/001 56 hard capsules (4 strips of 14 capsules) EU/1/11/747/002 8 hard capsules (1 strip of 8 capsules) EU/1/11/747/003 56 hard capsules (7 strips of 8 capsules)
EU/1/11/747/001 56 trdih kapsul (4 pretisni omoti s 14 kapsulami) EU/1/11/747/002 8 trdih kapsul (1 pretisni omot z 8 kapsulami) EU/1/11/747/003 56 trdih kapsul (7 pretisnih omotov z 8 kapsulami)
• if you/your child are taking aminoglycoside antibiotics used to treat infections caution must be taken;
• če vi ali vaš otrok jemljete aminoglikozidne antibiotike za zdravljenje okužb, morate biti previdni;
Colobreathe is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older (see section 5.1).
Zdravilo Colobreathe je indicirano za zdravljenje kroničnih pljučnih okužb z bakterijo Pseudomonas aeruginosa pri bolnikih s cistično fibrozo (CF), starih 6 let in več (glejte poglavje 5.1).
Актавис ЕАД Teл: +359 2 489 95 82
Teл: +359 2 489 95 82
Other medicines and Colobreathe
Druga zdravila in zdravilo Colobreathe
Colistimethate sodium (CMS) is a cyclic polypeptide antibacterial active substance that is derived from Bacillus polymyxa var. colistinus and belongs to the polymyxin group.
Mehanizem delovanja Natrijev kolistimetat je ciklična polipeptidna protibakterijska učinkovina, pridobljena iz Bacillus polymyxa var. colistinus.
Vomiting, nausea Diarrhoea, toothache, salivary hypersecretion, flatulence
Bolezni prebavil disgevzija bruhanje, navzea driska, zobobol, hipersekrecija sline, flatulenca
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%).
Pri zdravljenju z zdravilom Colobreathe so najpogosteje poročali o naslednjih neželenih učinkih, izraženih v odstotkih: kašelj (55 %), neprijeten okus (51%), draženje žrela, (34 %),
Do not store Colobreathe above 25oC.
Zdravilo Colobreathe shranjujte pri temperaturi do 25 oC.
There is very low transpulmonary absorption of colistimethate after inhalation of Colobreathe (see section 5.2).
Po inhaliranju zdravila Colobreathe je pljučna absorpcija kolistimetata zelo majhna (glejte poglavje 5.2).
To pierce the capsule:
Prebodite kapsulo:
Other possible side effects
Dodatni možni neželeni učinki
How it works Colobreathe works by destroying the bacterial cell membrane, having a lethal effect on them.
Zdravilo Colobreathe deluje tako, da uničuje celične membrane bakterij, kar ima na bakterije smrtonosni učinek.
The Physician and patient “DVDs/leaflet forms” should contain the following key elements and messages:
• podatke »DVD za bolnika« v »obliki brošure z navodili« za bolnike, ki nimajo dostopa do predvajalnika DVD »DVD/podatki v obliki brošure z navodili« za zdravnike in bolnike morajo vsebovati naslednje bistvene elemente in sporočila:
Colistimethate sodium may be secreted in the breast milk.
Natrijev kolistimetat se lahko izloča v materino mleko.
Uncommon: may affect up to 1 in 100 people
Občasni: pojavijo se lahko pri do 1 bolniku od 100 bolnikov
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).
Pri sočasni uporabi natrijevega kolistimetata in zdravil, ki lahko delujejo nefrotoksično ali nevrotoksično, vključno z nedepolarizirajočimi mišičnimi relaksanti, je potrebna previdnost (glejte poglavje 4.5).
• already have a muscle condition known as myasthenia gravis or the inherited condition,
• bolezen mišic, imenovano miastenija gravis ali podedovano bolezen, imenovano porfirija;
For use with the Turbospin inhaler only.
Samo za uporabo z inhalatorjem Turbospin.
Forced expiratory volume decreased
Preiskave zmanjšanje forsiranega ekspiratornega volumna
Common: may affect up to 1 in 10 people
Pogosti: pojavijo se lahko pri do 1 bolniku od 10 bolnikov
Co-treatment with colistimethate sodium and macrolides such as azithromycin and clarithromycin, or fluoroquinolones such as norfloxacin and ciprofloxacin should be undertaken with caution in patients with myasthenia gravis (see section 4.4).
Pri bolnikih z miastenijo gravis naj sočasno zdravljenje z natrijevim kolistimetatom in makrolidi, kot sta azitromicin in klaritromicin, ali fluorokinoloni, kot sta norfloksacin in ciprofloksacin, poteka previdno (glejte poglavje 4.4).
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.
Če ste vi/vaš otrok pozabili uporabiti zdravilo Colobreathe Če vi/vaš otrok pozabite uporabiti odmerek zdravila Colobreathe, vzemite (vi/vaš otrok) izpuščeni odmerek takoj, ko se spomnite.
• Now, with the capsule locked in place, continue pushing the piston as far as it will go and then release.
• Ko je kapsula v položaju, potisnite bat do konca in ga nato sprostite.
What Colobreathe looks like and contents of the pack
Izgled zdravila Colobreathe in vsebina pakiranja
• 56 hard capsules and one Turbospin powder inhaler device sufficient for 4 weeks use.
• 56 trdih kapsul - en inhalator za prašek Turbospin, kar zadošča za 4 tedne uporabe;
Clean the Turbospin inhaler after each dose using the following procedure: 1.
Čiščenje inhalatorja Turbospin Inhalator Turbospin očistite po vsakem odmerku, in sicer na naslednji način:
Polymyxins work by damaging the cell membrane and the resulting physiological effects are lethal to the bacterium.
Polimiksin deluje tako, da poškoduje celično membrano, kar fiziološko pomeni smrt za bakterijo.
Inhalation powder, hard capsule (inhalation powder) Hard transparent PEG-gelatin capsules containing a fine white powder.
prašek za inhaliranje, trde kapsule (prašek za inhaliranje) Trde prozorne PEG-želatinske kapsule, ki vsebujejo droben bel prašek.
It is possible while using Colobreathe that you may experience dizziness, confusion or have problems with your sight.
Pri uporabi zdravila Colobreathe se lahko pojavijo omotica, zmedenost ali težave z vidom.
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.
Če imate vi ali vaš otrok kakršne koli težave z ledvicami ali živčevjem, morate biti pri uporabi zdravila Colobreathe previdni.
Each 8 capsule pack contains one Turbospin powder inhaler device and 1 blister of 8 hard capsules sufficient for 4 days use.
Eno pakiranje z 8 kapsulami vsebuje en inhalator za prašek Turbospin in en pretisni omot z 8 trdimi kapsulami, kar zadošča za 4 dni uporabe.
• Allergic (hypersensitivity) reactions, the signs may include rash and itching
• alergijske (preobčutljivostne) reakcije, ki se med drugim kažejo kot izpuščaj in srbenje,
Therefore, dose adjustment in patients with renal impairment is not considered necessary.
Bolnikom z okvaro ledvic torej ni treba prilagoditi odmerka.
How to use Colobreathe
Kako uporabljati zdravilo Colobreathe
There are no or limited amount of data from the use of inhaled colistimethate sodium in pregnant women.
Podatkov o uporabi inhaliranega natrijevega kolistimetata pri nosečnicah ni oziroma so omejeni.
The order in which other treatments should be taken or carried out
Vrstni red izvajanja drugih oblik zdravljenja
Remove a single capsule from the blister.
Iz pretisnega omota vzemite eno kapsulo.
Sore throat or mouth has been reported with nebulised colistimethate sodium and may occur with Colobreathe.
Pri natrijevem kolistimetatu, danem z nebulatorjem, so poročali o vnetju grla, pojavi pa se lahko tudi z zdravilom Colobreathe.
Hold that position before continuing to follow through with the piercing.
Držite jo v tem položaju in nadaljujte.
You can check whether the capsule is empty by unscrewing the mouthpiece and checking the capsule.
Ali je kapsula prazna, se lahko prepričate tako, da odvijete ustnik in jo pregledate.
• 8 hard capsules and one Turbospin inhaler device sufficient for 4 days use.
• 8 trdih kapsul - en inhalator za prašek Turbospin, kar zadošča za 4 dni uporabe.
In the 24-week clinical study, where Colobreathe was administered twice daily to adults and children aged 6-17, the adverse reactions identified in the paediatric population were similar to that for the overall population.
V 24-tedenski klinični študiji, kjer so zdravilo Colobreathe dajali dvakrat na dan odraslim in otrokom,
The other ingredients are: Capsule Shell Gelatin polyethylene glycol sodium lauryl sulfate purified water
Sestavine PEG-želatinskih trdih kapsul: želatina polietilenglikol prečiščena voda natrijev lavrilsulfat
Each capsule contains 1,662,500 IU, which is approximately equal to 125 mg of colistimethate sodium.
Ena kapsula vsebuje 1.662.500 i.e., kar ustreza približno 125 mg natrijevega kolistimetata.
Physico-chemical data suggest excretion of colistimethate sodium in human milk.
Dojenje Na podlagi fizikalno-kemijskih podatkov se predvideva izločanje natrijevega kolistimetata v materino mleko.
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.
Manj kot 3 % odmerka so se izločili z urinom v obliki natrijevega kolistimetata in kolistina.
• if you/your child are taking colistimethate by injection or nebulisation caution must be taken;
• če vi ali vaš otrok uporabljate kolistimetat v obliki injekcij ali z nebulizatorjem, morate biti previdni;
Now replace the mouthpiece by screwing it back into place.
Znova namestite ustnik, tako da ga privijete nazaj na ustrezno mesto.
Colistimethate is not significantly absorbed from the lung after inhalation of Colobreathe.
Absorpcija kolistimetata iz pljuč po inhalaciji zdravila Colobreathe ni obsežna.
Absorption of colistimethate from the gastro-intestinal tract does not occur to any appreciable extent in the normal individual.
Absorpcija kolistimetata iz prebavil pri zdravih osebah ne poteka v omembe vrednem obsegu.
Preparing the Turbospin
Priprava inhalatorja Turbospin
Each capsule contains 1,662,500 IU (approximately equivalent to 125 mg) of colistimethate sodium.
Ena kapsula vsebuje 1.662.500 i.e. (kar ustreza približno 125 mg) natrijevega kolistimetata.
Caution should be taken with concomitant use of Colobreathe and parenteral or nebulised colistimethate sodium.
Pri sočasni uporabi zdravila Colobreathe in natrijevega kolistimetata, danega parenteralno ali z nebulizatorjem, je potrebna previdnost.
• Vomiting, nausea
• bruhanje, slabost,
Each 56 capsule pack contains one Turbospin powder inhaler device and 7 blisters of 8 capsules or one Turbospin powder inhaler device and 4 blisters of 14 capsules (56 hard capsules) sufficient for 4 weeks use.
Eno pakiranje s 56 kapsulami vsebuje en inhalator za prašek Turbospin in 7 pretisnih omotov z 8 kapsulami ali en inhalator za prašek Turbospin in 4 pretisne omote s 14 kapsulami (56 trdih kapsul),
No force is required.
Navedba smiselno ni potrebna.
Haemoptysis, bronchospasm, asthma, wheezing, chest discomfort, lower respiratory tract infection, productive cough, crackles lung
Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja, kašelj, disfonija, draženje grla hemoptiza, bronhospazem, astma, sopenje, nelagodje v prsnem košu, okužba spodnjih dihal, produktiven kašelj,
Colobreathe is inhaled into the lungs as a powder from the capsule using the hand-held inhaler called the Turbospin.
Zdravilo Colobreathe v obliki praška iz kapsule se inhalira v pljuča z ročnim inhalatorjem, imenovanim Turbospin.
• Cough, throat irritation
• kašelj, draženje žrela,
Colobreathe capsules are to be used only with the Turbospin powder inhaler.
Zdravilo Colobreathe kapsule se uporabljajo samo z inhalatorjem za prašek Turbospin.
Do not swallow the capsules.
Kapsul ne zaužijte.
High concentrations of total free colistin (mean 23.5mg/L) and total colistimethate (mean 178mg/L) were observed in sputum at 1 hour post-dose on Day 8 following BID dosing for 7 days across all age groups.
Na 8. dan po 7-dnevnem odmerjanju dvakrat dnevno so v vseh starostnih skupinah 1 uro po odmerku opazili v sputumu visoke koncentracije celotnega prostega kolistina (srednja vrednost 23,5 mg/l) in celotnega kolistimetata (srednja vrednost 178 mg/l).
Weight fluctuation, decreased appetite
Presnovne in prehranske motnje nihanje telesne mase, zmanjšanje apetita
Clean the chamber using a tissue or cotton bud.
Komoro očistite s papirnatim robčkom ali kosmičem vate.
Unscrew the mouthpiece, exposing the chamber of the Turbospin inhaler.
Odvijte ustnik, da razkrijete komoro inhalatorja Turbospin.
• have reacted badly to inhaled dry powder medicines previously unless this has already been discussed with your doctor.
Povejte svojemu zdravniku, če je pri vas/vašem otroku pojavi kaj od naslednjega: • predhoden slab odziv na inhalirano zdravilo v obliki suhega praška, razen če ste se o tem že pogovorili s svojim zdravnikom;
• Excessive production of saliva
• pretirano izločanje sline,
The capsules must not be swallowed.
Izpiralne tekočine ne smete pogoltniti.
Taking Colobreathe using the Turbospin inhaler Preparing the Turbospin
Jemanje zdravila Colobreathe z uporabo inhalatorja Turbospin Priprava inhalatorja Turbospin
If you/your child needs to have other forms of colistimethate either by injection or nebulisation caution should be used but your doctor should be aware of this.
Če morate vi ali vaš otrok uporabljati kolistimetat v drugi obliki, z injiciranjem ali nebulizatorjem, morate biti previdni.
( Mean)
(povprečje)
Taking Colobreathe using the Turbospin inhaler
Jemanje zdravila Colobreathe z uporabo inhalatorja Turbospin
The tiny particles of medication in the capsule are picked up by the airflow and carried down your airway into your lungs.
S pretokom zraka skozi dihalne poti se drobni delci zdravila prenesejo iz kapsule v pljuča.
The active substance is colistimethate sodium.
Zdravilna učinkovina je natrijev kolistimetat.
Balance disorder, headache
Bolezni živčevja motnje ravnotežja, glavobol konvulzije, somnolenca
Discard the Turbospin inhaler after the completion of a treatment pack.
Inhalator Turbospin zavrzite, ko porabite pakiranje zdravila.
Posology
Ustnik
Do not stop your treatment early unless your doctor says you can.
Če ste vi/vaš otrok prenehali uporabljati zdravilo Colobreathe Ne prenehajte z zdravljenjem, razen če vam zdravnik naroči, da lahko.
Therefore, dose adjustment in low age groups is considered not necessary.
Zato ni videti, da bi mlajši bolniki potrebovali prilagojen odmerek.
Colobreathe 1,662,500 IU inhalation powder, hard capsules
Colobreathe 1.662.500 i.e. prašek za inhaliranje, trde kapsule
• Toothache
• tesnoba,
Bronchospasm or coughing may occur on inhalation.
Po inhaliranju se lahko pojavi bronhospazem ali kašelj.
The rinse should not be swallowed.
Vode, s katero izpirate, ne smete pogoltniti.
Do not try to loosen the capsule by repeatedly pressing the piston.
Odstranite pokrovček tako, da ga nežno povlečete.
Skin rash may also indicate hypersensitivity and if this occurs treatment should be withdrawn.
Tudi kožni izpuščaj lahko nakazuje preobčutljivost.
Haemoptysis
Tobramicin
• Nose bleeds, catarrh (mucus in your nose, which may make you feel blocked up),
• krvavitev iz nosu, katar (sluz v nosu, zaradi katere čutite zamašenost), izkašljevanje goste zelene sluzi, bolečina v žrelu in sinusih,
Immune system disorders
Bolezni imunskega sistema preobčutljivost na zdravilo
Contents of the pack and other information
Shranjevanje zdravila Colobreathe Vsebina pakiranja in dodatne informacije
Colobreathe 1,662,500 IU inhalation powder, hard capsules colistimethate sodium
Colobreathe 1.662.500 i.e. prašek za inhaliranje, trde kapsule natrijev kolistimetat