FrancophonIA/ELRC3.0 huggingface dataset:
English: • red ear drum
Croatian: • crvenilo bubnjića
English: • blood tests showing increased levels of chloride, potassium, sodium, uric acid, protein total,
Croatian: • povišene razine klorida, kalija, natrija, mokraćne kiseline, ukupnih proteina, gama glutamiltransferaze, kreatin fosfokinaze, ureje i kreatinina na pretragama krvi
English: • very severe skin reactions, including Steven-Johnson syndrome and dermatitis exfoliative These skin reactions are life-threatening rashes with fever and blisters and can effect the lining of the mouth and genitals.
Croatian: Te reakcije kože su osipi opasni po život s vrućicom i plikovima te mogu utjecati na sluznicu usne šupljine i genitalija.
English: Acute renal failure, renal failure, pre-renal failure, renal disorder, anuria, nephritis, and increased blood creatinine have been reported in patients with influenza who were receiving peramivir.
Croatian: U bolesnika oboljelih od gripe koji su primali peramivir zabilježeni su akutno zatajenje bubrega, zatajenje bubrega, prerenalno zatajenje bubrega, poremećaj funkcije bubrega, anurija, nefritis te povišena razina kreatinina u krvi.
English: • inflammation of stomach lining
Croatian: • upala želučane ovojnice
English: Administer the diluted solution via intravenous infusion over 15 to 30 minutes.
Croatian: 6. Razrijeđenu otopinu primijenite intravenskom infuzijom u trajanju od 15 do 30 minuta.
English: • skin inflammation, eczema, rash, nettle-rash
Croatian: • upala kože, ekcem, osip, koprivnjača
English: Clear, colourless, solution.
Croatian: Bistra bezbojna otopina.
English: Adverse Reaction According to Frequency*
Croatian: Nuspojave prema učestalosti*
English: • Dilute the required dose of peramivir concentrate in sodium chloride 9 mg/mL (0.9 %) or
Croatian: • Potrebnu dozu koncentrata peramivira razrijedite otopinom natrijeva klorida od 9 mg/ml (0,9 %) ili 4,5 mg/ml (0,45 %) za infuziju, 5-postotnom otopinom dekstroze ili otopinom Ringerova laktata do volumena od 100 ml.
English: • chest discomfort, fatigue
Croatian: • nelagoda u prsima, umor
English: Breast-feeding
Croatian: Speke
English: • upper abdominal pain, abdominal discomfort
Croatian: • bol u gornjem dijelu trbuha, nelagoda u trbuhu
English: 95% CI
Croatian: 95%-tni CI
English: Do not use water.
Croatian: Nemojte upotrijebiti vodu.
English: Explain that the device should be discarded after 28 days.
Croatian: Objašnjenje da se uređaj mora baciti nakon 28 dana.
English: Always use this medicine exactly as your doctor has told you.
Croatian: Uvijek primijenite lijek točno onako kako Vam je rekao Vaš liječnik.
English: You/your child must not take 2 doses within 12 hours.
Croatian: Vi/Vaše dijete ne smijete uzeti 2 doze unutar 12 sati.
English: If it is not empty, repeat steps 7, 8 and 9 until you have inhaled all of the contents.
Croatian: Ako nije prazna, ponovite korake 7, 8 i 9 dok niste udahnuli sav sadržaj.
English: Some people will get this infection whilst very young but for others it will be much later.
Croatian: Neki se zaraze vrlo mladi, dok se u drugih to dogodi mnogo kasnije.
English: • Unpleasant taste
Croatian: • neugodan okus.
English: • If this happens, you may be able to feel these pieces on your tongue or in your airways.
Croatian: • Ako se to dogodi, možda ćete osjetiti te komadiće na jeziku ili u dišnim putevima.
English: • Information on the need to comply with the treatment in order to maximise the potential benefits.
Croatian: • Informacije o potrebi pridržavanja načina liječenja kako bi se najbolje povećale moguće koristi.
English: • Hoarse or weak, or even loss of the voice
Croatian: • promukao ili slab glas, ili čak gubitak glasa
English: If this infection is not properly controlled it will cause damage to the lungs.
Croatian: Ako ta infekcija nije odgovarajuće kontrolirana uzrokovat će oštećenje pluća.
English: Do not drive or use any machines until the symptoms have gone away.
Croatian: Nemojte upravljati vozilima ni strojevima dok ti simptomi ne nestanu.
English: Breathe out slowly.
Croatian: Polako izdahnite.
English: Hold that position before continuing to follow through with the piercing.
Croatian: Zadržite taj položaj prije nego nastavite s probijanjem.
English: The first dose should be given under medical supervision.
Croatian: Prva doza mora se dati pod liječničkim nadzorom.
English: Once you have removed the capsule it must be used immediately.
Croatian: Kada izvadite kapsulu, morate je odmah iskoristiti.
English: Protein binding is low.
Croatian: Vezivanje na proteine je niskog postotka.
English: • Ringing or buzzing noises in the ear, problems with balance
Croatian: • zvonjenje ili zujanje u uhu, poteškoće s ravnotežom
English: Do not stop your treatment early unless your doctor says you can.
Croatian: Ne prekidajte liječenje prijevremeno, osim ako Vam liječnik kaže da smijete.
English: • The chances of the capsule breaking into pieces are increased if the capsule is pierced more than once during Step 6.
Croatian: • Mogućnost da se kapsula slomi na komadiće je veća ako se kapsula probije više od jedanput u koraku 6.
English: Treatment may be continued for as long as the physician considers that the patient is obtaining clinical benefit.
Croatian: Liječenje se može nastaviti dokle god liječnik smatra da bolesnik ima kliničke koristi.
English: Nonclinical data reveal no special hazard for humans based on conventional studies of genotoxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja genotoksičnosti.
English: No in-vivo interaction studies have been performed.
Croatian: Nisu provedena ispitivanja interakcija in-vivo.
English: Like all medicines this medicine can cause side effects, although not everyone gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti u svakoga.
English: There were 32 patients aged 6-12 years, 41 patients aged 13-17 years and 114 patients aged 18 years and older.
Croatian: 32 bolesnika bilo je u dobi od 6 do 12 godina, 41 bolesnika u dobi od 13 do 17 godina i 114 bolesnika u dobi od 18 godina i starijih.
English: Explanation that using inhaled antibiotics can reduce the need for intravenous antibiotics.
Croatian: Objašnjenje da inhalirani antibiotici mogu smanjiti potrebu za intravenskim antibioticima.
English: However, overdose may possibly result in higher systemic exposure.
Croatian: Međutim, predoziranje može rezultirati višom sistemskom ekspozicijom.
English: No force is required.
Croatian: Nije potrebno primjenjivati silu.
English: The results of the Intent-To-Treat (ITT) population for the primary efficacy outcome are shown below:
Croatian: Rezultati populacije planirane za liječenje (Intent-To-Treat, ITT) u pogledu primarnog ishoda djelotvornosti prikazani su u nastavku:
English: No dose adjustment is considered to be necessary (see section 5.2).
Croatian: Smatra se da nije potrebno prilagođavati dozu (vidjeti dio 5.2).
English: The data from the primary outcome parameter, change in FEV1 % predicted, are not normally distributed.
Croatian: Podaci parametra primarnog ishoda, promjena očekivane vrijednosti FEV1 %, nisu normalno distribuirani.
English: The safety of Colobreathe has been assessed in a total of 237 subjects (225 cystic fibrosis patients and 12 healthy volunteers).
Croatian: Sigurnost lijeka Colobreathe procijenjena je na ukupno 237 ispitanika (225 bolesnika s cističnom fibrozom i 12 zdravih dobrovoljaca).
English: • Discussion about common side effects and in particular cough and taste abnormality: Explanation that:
Croatian: • Rasprava o čestim nuspojavama i naročito o kašlju i neuobičajenom okusu: Objašnjenje da:
English: It should be noted that treatment was not interrupted when patients received concomitant parenteral antibacterial active substances.
Croatian: Treba napomenuti da liječenje nije bilo prekinuto kada su bolesnici istodobno parenteralno dobivali antibakterijske djelatne tvari.
English: Do not give Colobreathe to children under the age of 6 years as it is not suitable for them.
Croatian: Djeci mlađoj od 6 godina nemojte davati Colobreathe jer za njih nije prikladan.
English: High PK variability was observed in all three groups.
Croatian: Visoka farmakokinetička varijabilnost opažena je u sve tri skupine.
English: • have reacted badly to inhaled dry powder medicines previously unless this has already been discussed with your doctor.
Croatian: • prethodno loše reagirali na inhalirani lijek u obliku suhog praška, osim ako ste o tome već razgovarali sa svojim liječnikom
English: Place the mouthpiece between your lips and teeth.
Croatian: Stavite nastavak za usta između usana i zuba.
English: There is no specific antidote, therefore management should be done by supportive treatment.
Croatian: Nema specifičnog antidota, stoga se za zbrinjavanje treba koristiti suportivno liječenje.
English: Capsules: no special requirements for disposal.
Croatian: Kapsule: nema posebnih zahtjeva za zbrinjavanje.
English: Patients should be warned not to drive or operate machines if this occurs.
Croatian: Bolesnike treba upozoriti da u tom slučaju ne upravljaju vozilima i da ne rade sa strojevima.
English: Then, breathe in slowly and deeply through your mouth at a rate sufficient for you to hear or feel the capsule spinning.
Croatian: Zatim, udahnite kroz usta polako i duboko, brzinom koja je dovoljna da čujete ili osjetite kako se kapsula okreće.
English: Consideration should be given to official guidance on the appropriate use of antibacterial active substances.
Croatian: Potrebno je razmotriti službene smjernice o odgovarajućoj primjeni antibakterijskih djelatnih tvari.
English: Adjusted Treatment difference
Croatian: Prilagođena razlika između liječenja
English: Date of first authorisation: 13/02/2012 Date of latest renewal: 26/09/2016
Croatian: Datum posljednje obnove odobrenja: 26/09/2016
English: Colobreathe is available in packs containing either 8 or 56 hard capsules.
Croatian: Colobreathe je dostupan u pakiranju koje sadrži 8 ili 56 tvrdih kapsula.
English: Adults and children of 6 years of age and older
Croatian: Odrasli i djeca u dobi od 6 godina ili starija
English: The ITT population excluded patients who had been treated but demonstrated no evidence of chronic infection.
Croatian: Iz populacije ITT bili su isključeni bolesnici koji su bili liječeni, a koji nisu imali znakova kronične infekcije.
English: If any of these effects become a problem, please contact your doctor who may change your treatment.
Croatian: Ako se bilo koji od tih učinaka razvije u tegobu, posavjetujte se sa svojim liječnikom, koji može promijeniti način liječenja.
English: Medication error
Croatian: Medikacijska pogreška
English: The subjects were aged 6 years and above and had an FEV1% predicted of 25-75%.
Croatian: Ispitanici su bili u dobi od 6 godina i stariji i imali su očekivanu vrijednost FEV1% od 25 do 75%.
English: • There should be a 12 hour gap between doses.
Croatian: • Između doza mora postojati razmak od 12 sati.
English: Tmax for total colistimethate occurred between 0.5 and 1 hour post-dose.
Croatian: Tmax ukupnog kolistimetata nastupio je između 0,5 i 1 sata nakon doze.
English: It can also result in neuromuscular blockade that can lead to muscular weakness, apnoea and possible respiratory arrest.
Croatian: Može rezultirati i neuromuskolarnom blokadom koja može voditi do mišićne slabosti, apneje i mogućeg respiracijskog aresta.
English: Do not try to loosen the capsule by repeatedly pressing the piston.
Croatian: Nemojte pokušavati osloboditi kapsulu pritiskanjem klipa više puta.
English: The safety and efficacy of Colobreathe in children under 6 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Colobreathe u djece mlađe od 6 godina nije ustanovljena.
English: Your doctor will decide how long you/your child's treatment should last.
Croatian: Vaš će liječnik odlučiti koliko dugo mora trajati liječenje za Vas/Vaše dijete.
English: The adjusted treatment difference and 95% confidence interval have been back transformed from log transformed data.
Croatian: Prilagođena razlika između liječenja i 95%-tni interval pouzdanosti bili su povratno transformirani iz prethodno logaritmiranih vrijednosti.
English: Inhale the medicine again by repeating Steps 7 and 8 to ensure you have emptied the capsule.
Croatian: 11. Ponovno udahnite lijek tako da ponovite korake 7 i 8 kako biste bili sigurni da ste ispraznili kapsulu.
English: Contents of the pack and other information What Colobreathe contains
Croatian: Sadržaj pakiranja i druge informacije Što Colobreathe sadrži
English: • 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.
Croatian: • Inhalator držite tako da je nastavak za usta u uspravnom položaju, klip nježno pritisnite prema gore dok ne dostigne vidljivu crtu - tada ćete osjetiti otpor i to će blokirati kapsulu u mjestu, tako da je spremna za probijanje.
English: Oral fungal super-infection
Croatian: Oralna gljivična superinfekcija
English: Treatment with colistimethate sodium or colistin did not induce the activity of any enzyme tested (CYP1A2, 2B6, 2C8, 2C9, 2C19 and 3A4/5).
Croatian: Liječenje kolistimetatnatrijem ili kolistinom nije izazvalo aktivnost nijednog ispitanog enzima (CYP1A2, 2B6, 2C8, 2C9, 2C19 i 3A4/5).
English: Convulsions, somnolence
Croatian: Konvulzije, somnolencija
English: Inhalation powder, hard capsule.
Croatian: Prašak inhalata, tvrda kapsula
English: An allergic reaction with Colobreathe is possible (typically serious allergic reactions may cause rashes, swelling of the face, tongue and neck, inability to breathe due to narrowing of the airways and loss of consciousness).
Croatian: Alergijska reakcija na Colobreathe je moguća (obično ozbiljne alergijske reakcije mogu izazvati osipe, oticanje lica, jezika i vrata, nemogućnost disanja zbog sužavanja dišnih puteva i gubitak svijesti).
English: Animal studies of safety pharmacology, repeated dose toxicity or toxicity to reproduction, employing routes assuring systemic exposure, showed no particular hazard.
Croatian: Ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza ili reproduktivne toksičnosti u životinja, s načinom davanja koji osigurava sistemsku ekspoziciju, ne ukazuju na poseban rizik.
English: The efficacy of Colobreathe has been demonstrated in a study of 24-weeks duration.
Croatian: Djelotvornost lijeka Colobreathe dokazana je u ispitivanju koje je trajalo 24 tjedna.
English: • Do not pierce the capsule more than once.
Croatian: • Kapsulu nemojte probijati više od jedanput.
English: • The capsule shell is made of gelatin, which is harmless to humans if swallowed or inhaled.
Croatian: • Ovojnica kapsule izrađena je od želatine, koja je bezopasna za ljude ako se proguta ili udahne.
English: Nephrotoxicity/neurotoxicity
Croatian: Nefrotoksičnost/neurotoksičnost
English: Penn Pharmaceutical Services Ltd. 23-24 Tafarnaubach Industrial Estate Tredegar, Gwent NP2 3AA United Kingdom
Croatian: Penn Pharmaceutical Services Ltd. 23-24 Tafarnaubach Industrial Estate Tredegar, Gwent NP2 3AA Ujedinjeno Kraljevstvo
English: The capsules are packed in blister packs supplied in cartons containing:
Croatian: Kapsule su pakirane u blister pakiranju u kutiji koja sadrži:
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare ((≥1/10,000 to <1/1,000), very rare <1/10,000), not known (cannot be estimated from the available data).
Croatian: i <1/100), rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: 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.
Croatian: Budući da se mehanizam djelovanja polimiksina razlikuje od mehanizma drugih antibakterijskih lijekova, ne očekuje se da bi rezistencija na kolistin i polimiksin samo po navedenom mehanizmu prouzročila rezistenciju na druge skupine lijekova.
English: • Detailed instructions about how to use the medication: starting from unpacking of the product and finishing with disposal of the used capsule and device.
Croatian: • Detaljne upute o primjeni lijeka: kako se otvara pakiranje lijeka i kako se na kraju odlažu iskorištene kapsule i uređaj.
English: Polymyxins persist in the liver, kidney, brain, heart and muscle.
Croatian: Polimiksini perzistiraju u jetri, bubrezima, mozgu, srcu i mišićima.
English: 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.
Croatian: Budući da se 80% parenteralne doze u nepromijenjenom obliku pojavljuje u urinu, i budući da nema izlučivanja putem žuči, može se pretpostaviti da se preostali lijek inaktivira u tkivima.
English: What Colobreathe is and what it is used for
Croatian: Što je Colobreathe i za što se koristi
English: Pharmacotherapeutic group: antibacterials for systemic use, other antibacterials.
Croatian: Farmakoterapijska skupina: antibakterijski lijekovi za sistemsku primjenu, ostali antibakterijski lijekovi.
English: Therefore, dose adjustment in patients with renal impairment is not considered necessary.
Croatian: Stoga se prilagođavanje doze u bolesnika s oštećenjem bubrega ne smatra potrebnim.
English: Occasionally, very small pieces of the capsule shell can get into your mouth or airways.
Croatian: Povremeno, vrlo mali komadići ovojnice kapsule mogu dospjeti u usta ili dišne puteve.
English: The following instructions should be adhered to by the patient when taking Colobreathe:
Croatian: Bolesnik se treba pridržavati sljedećih uputa prilikom uzimanja lijeka Colobreathe:
English: 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.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja kolistimetatnatrijem uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: The dose interval should be as close as possible to 12 hours.
Croatian: Razmak između doza mora biti što bliži 12 sati.
English: It comes away with a gentle pull.
Croatian: Skida se nježnim povlačenjem.
English: Store in the original package until immediately before use in order to protect from moisture.
Croatian: Čuvati u originalnom pakiranju do neposredno prije primjene radi zaštite od vlage.
English: You/your child may get an unpleasant taste in your mouth after inhaling Colobreathe.
Croatian: Kod Vas/Vašeg djeteta može se pojaviti neugodan okus u ustima nakon udisanja lijeka Colobreathe.
English: This may be related to Candida albicans infection or hypersensitivity.
Croatian: To može biti povezano s infekcijom gljivicom Candida albicans ili s preosjetljivošću.
English: − these are only of nuisance value for most patients
Croatian: − predstavljaju za većinu bolesnika samo neugodu
English: Some detail about cleaning the Turbospin device.
Croatian: Neki detalji o čišćenju uređaja Turbospin.
English: 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:
Croatian: Nositelj odobrenja će osigurati da se svim liječnicima koji bi mogli propisati ili primijeniti lijek Colobreathe isporuči edukacijski materijal za zdravstvene radnike i bolesnike koji sadrži:
English: Polymyxins are selective for Gram-negative bacteria that have a hydrophobic outer membrane.
Croatian: Polimiksini su selektivni za gram-negativne bakterije, koje imaju hidrofobnu vanjsku membranu.
English: When the capsule is empty, unscrew the mouthpiece, then remove and discard the empty capsule.
Croatian: Kada je kapsula prazna, odvijte nastavak za usta, zatim uklonite i bacite praznu kapsulu.
English: 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.
Croatian: Kako bi se osigurala pravilna primjena lijeka, potrebno je da liječnik ili drugi zdravstveni radnik uputi bolesnika kako koristiti inhalator, a prva doza mora se dati pod liječničkim nadzorom.
English: If you/your child experience signs of an allergic reaction you should seek urgent medical attention.
Croatian: Ako se kod Vas/Vašeg djeteta pojave znakovi alergijske reakcije, hitno potražite medicinsku pomoć.
English: 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.
Croatian: Epidemiološka granična vrijednost kolistimetatnatrija za Pseudomonas aeruginosa, s kojom se populacija divljeg tipa razlikuje od izolata sa stečenom rezistencijom, je 4 mg/l.
English: 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.
Croatian: U 24-tjednom kliničkom ispitivanju, u kojem se Colobreathe davao dvaput dnevno odraslima i djeci u dobi od 6 do 17 godina, nuspojave utvrđene u pedijatrijskoj populaciji bile su slične onima u sveukupnoj populaciji.
English: In the 24 week clinical study, the following adverse reactions were observed across all ages.
Croatian: U 24-tjednom kliničkom ispitivanju, sljedeće su nuspojave primijećene u svim starosnim skupinama.
English: Once all the contents have been inhaled, rinse your mouth out well with water and spit out.
Croatian: 13. Kada ste udahnuli sav sadržaj, dobro isperite usta vodom i ispljunite.
English: Tell your doctor if you/your child are taking, have recently taken or might use any other medicines, and in particular:
Croatian: Obavijestite liječnika ako Vi/Vaše dijete uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koji drugi lijek.
English: More common signs and symptoms of intravenous overdose include unsteadiness, paraesthesia and dizziness.
Croatian: Češći znakovi i simptomi intravenskog predoziranja uključuju nemir, paresteziju i omaglicu.
English: Weight fluctuation, decreased appetite
Croatian: Oscilacije težine, smanjeni apetit
English: Your doctor, pharmacist or nurse should show you/your child how to inhale the medicine when you/your child first start treatment:
Croatian: Vaš liječnik, ljekarnik ili medicinska sestra treba Vama/Vašem djetetu pokazati na početku liječenja kako se lijek udiše:
English: • Unusual noises in the chest (your doctor would hear this when listening to your lungs with a stethoscope)
Croatian: • neobični šumovi u prsnom košu (čuje ih Vaš liječnik kada sluša pluća stetoskopom)
English: Naturally resistant Gram-negative bacteria, such as Proteus mirabilis and Burkholderia cepacia, show complete substitution of their lipid phosphate by ethanolamine or aminoarabinose.
Croatian: Prirodno rezistentne Gram-negativne bakterije, kao što su Proteus mirabilis i Burkholderia cepacia, pokazuju potpunu zamjenu svojih lipidnih fosfata etanolaminom ili aminoarabinozom.
English: The estimated mean terminal half-lives for total CMS and total free colistin were 3.0 and 6.4 h, respectively.
Croatian: Procijenjeni prosječni terminalni poluvijekovi za ukupni KMN i ukupni slobodni kolistin bili su 3,0 h odnosno 6,4 h.
English: 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.
Croatian: Inhalator Turbospin izvadite iz usta i zadržite dah približno 10 sekundi, ili dokle god Vam to ne stvara nelagodu, zatim polako izdahnite.
English: • Diarrhoea, wind
Croatian: • proljev, vjetrovi