FrancophonIA/ELRC3.0 huggingface dataset:
English: Children and adults with kidney problems, including those on dialysis, are usually given lower doses.
Croatian: Djeca i odrasli s bubrežnim tegobama, uključujući one na dijalizi, obično primaju niže doze.
English: For special precautions for disposal and handling of reconstituted solutions, see section 6.6.
Croatian: Za posebne mjere za zbrinjavanje i rukovanje rekonstituiranim otopinama vidjeti dio 6.6.
English: What you need to know before you <take> <use> [Product name]
Croatian: Što morate znati prije nego počnete <uzimati> <primjenjivati> [naziv lijeka]
English: If you are quite unwell, you will be given a higher dose of 9 million units once at the start of treatment.
Croatian: Ako ste jako bolesni, na početku liječenja ćete jedanput primiti veću dozu od 9 milijuna jedinica.
English: Three times daily dosing is recommended.
Croatian: Preporučuje se doziranje triput na dan.
English: How to <take><use> [Product name]
Croatian: Kako <uzimati> <primjenjivati > [naziv lijeka]
English: Relevant clinical guidance on treatment regimens, including duration of treatment, periodicity and coadministration of other antibacterial agents should be adhered to.
Croatian: Potrebno je pridržavati se relevantnih kliničkih smjernica o režimima liječenja, uključujući trajanje liječenja, periodičnost i istodobnu primjenu drugih antibakterijskih lijekova.
English: A tabulated presentation of the posology could be considered acceptable.
Croatian: Tablični prikaz doziranja mogao bi biti prihvatljiv.
English: [Information on suitable nebuliser(s) and output characteristics may be included]
Croatian: [Mogu se uključiti informacije o prikladnom(im) atomizatoru(ima) i izlaznim karakteristikama uređaja]
English: The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Croatian: Prevalencija stečene rezistencije za određene vrste može se razlikovati po geografskim regijama i vremenskim razdobljima pa je poželjno imati lokalne podatke o rezistenciji, osobito kod liječenja teških infekcija.
English: In particular there are limited safety data for the use of high doses (> 6MIU/day) and the use of a loading dose, and for special populations (patients with renal impairment and the paediatric population).
Croatian: Osobito su ograničeni podaci o sigurnosti primjene visokih doza (> 6 milijuna IU/dan) i primjene udarne doze, ali i za posebne populacije (bolesnike s oštećenjem bubrežne funkcije i pedijatrijsku populaciju).
English: [Product name] is given by injection to treat some types of serious infections caused by certain bacteria.
Croatian: [Naziv lijeka] daje se injekcijom za liječenje nekih vrsta ozbiljnih infekcija koje uzrokuju određene bakterije.
English: The volume of distribution is relevantly enlarged in critically ill subjects.
Croatian: Volumen distribucije značajno je povećan u kritičnih bolesnika.
English: For dose preparation, particularly where combination of multiple vials is needed, reconstitution of the required dose must be performed using strict aseptic technique (see section 6.6).
Croatian: Prilikom pripreme doze, osobito kada je potrebno kombinirati veći broj bočica, rekonstitucija potrebne doze mora se provesti strogom primjenom aseptične tehnike (vidjeti dio 6.6).
English: No in vivo interaction studies have been performed.
Croatian: Nisu provedena ispitivanja interakcija in vivo.
English: [Product name] is used when these infections are cause by specific bacteria called Pseudomonas aeruginosa.
Croatian: [Naziv lijeka] se primjenjuje kada te infekcije uzrokuje određena bakterija koja se zove Pseudomonas aeruginosa.
English: The following dose recommendations are made based on limited population-pharmacokinetic data in critically ill patients (see section 4.4):
Croatian: Sljedeće preporuke za doziranje temelje se na ograničenim populacijskim farmakokinetičkim podacima prikupljenima u kritičnih bolesnika (vidjeti dio 4.4):
English: CMS is eliminated predominantly by the kidneys via glomerular filtration.
Croatian: KMN se pretežno eliminira kroz bubrege glomerularnom filtracijom.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Croatian: Potrebno je razmotriti službene smjernice o odgovarajućoj primjeni antibakterijskih lijekova.
English: Colistimethate sodium should only be used when other, more commonly prescribed antibiotics are not effective or not appropriate.
Croatian: Kolistimetatnatrij je potrebno primjenjivati samo kada drugi, češće propisivani antibiotici nisu djelotvorni ili primjereni.
English: In critically ill patients, half-life has been reported to be prolonged to around 9-18h.
Croatian: Prijavljeno je i da se u kritičnih bolesnika poluvijek produljuje na približno 9-18 sati.
English: For inhalation use.
Croatian: Za inhalacijsku primjenu.
English: In case of an allergic reaction, treatment with colistimethate sodium must be discontinued and appropriate measures implemented.
Croatian: U slučaju alergijske reakcije, mora se obustaviti liječenje kolistimetatnatrijem i moraju se uvesti odgovarajuće mjere.
English: The benefit of prolonged treatment duration should be balanced against the potentially increased risk of renal toxicity.
Croatian: Korist dugotrajna liječenja potrebno je odvagnuti u odnosu na potencijalno povećan rizik od bubrežne toksičnosti.
English: The most commonly observed adverse effect of CMS administration was aseptic meningitis (see section 4.8).
Croatian: Najčešće primijećena nuspojava primjene KMN-a bio je aseptični meningitis (vidjeti dio 4.8).
English: High serum concentrations of colistimethate sodium, which may be associated with overdosage or failure to reduce the dosage in patients with renal impairment, have been reported to lead to neurotoxic effects such as facial paraesthesia, muscle weakness, vertigo, slurred speech, vasomotor instability, visual disturbances, confusion, psychosis and apnoea.
Croatian: Prijavljeno je da visoke koncentracije kolistimetatnatrija u serumu, koje bi mogle biti povezane s predoziranjem ili izostankom smanjenja doze u bolesnika s oštećenjem bubrežne funkcije, dovode do neurotoksičnih učinaka poput parestezije lica, mišićne slabosti, vrtoglavice, nerazgovijetna govora, vazomotoričke nestabilnosti, vidnih smetnji, konfuzije, psihoze i apneje.
English: The dosage can be adjusted depending on the severity of the condition and clinical response.
Croatian: Doza se može prilagoditi ovisno o težini bolesti i kliničkom odgovoru.
English: There are limited clinical data on the efficacy and safety of intravenous colistimethate sodium.
Croatian: Ograničeni su klinički podaci o djelotvornosti i sigurnosti intravenske primjene kolistimetatnatrija.
English: [Product name] is given to you by your doctor as an infusion into a vein over 30 - 60 minutes.
Croatian: [Naziv lijeka] će Vam dati Vaš liječnik u obliku infuzije u venu tijekom 30-60 minuta.
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 kolistimetnatrija jer su iskustva malobrojna, a postoji mogućnost aditivne toksičnosti.
English: Colistimethate sodium or colistin did not induce the activity of any P 450 (CYP) enzyme tested (CYP1A2, 2B6, 2C8, 2C9, 2C19 and 3A4/5) in in vitro studies in human hepatocytes.
Croatian: Niti kolistimetatnatrij niti kolistin u in vitro ispitivanjima na ljudskim hepatocitima nije inducirao aktivnost nijednog ispitanog enzima P450 (CYP) (CYP1A2, 2B6, 2C8, 2C9, 2C19 i 3A4/5).
English: fAUC/ MIC is considered to be correlated with clinical efficacy.
Croatian: Smatra se da je fAUC/MIK u korelaciji s kliničkom djelotvornošću.
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 onoga drugih antibakterijskih lijekova, ne očekuje se da će rezistencija na kolistin i polimiksin uzrokovana prethodno opisanim mehanizmom prouzročiti rezistenciju na druge skupine lijekova.
English: It is recommended that colistimethate sodium (CMS) should be administered under the supervision of physicians with appropriate experience in its use.
Croatian: Preporučuje se primjenjivati kolistimetatnatrij (KMN) pod nadzorom liječnika koji imaju odgovarajuće iskustvo s njegovom primjenom.
English: Pharmacotherapeutic group: antibacterials for systemic use, other antibacterials, polymyxins.
Croatian: Farmakoterapijska skupina: antibakterijski lijekovi za sistemsku primjenu, ostali antibakterijski lijekovi, polimiksini.
English: If you suffer from myasthenia gravis and are also taking other antibiotics called macrolides (such as azithromycin, clarithromycin or erythromycin) or antibiotics called fluoroquinolones (such as ofloxacin, norfloxacin and ciprofloxacin), taking [Product name] further increases the risk of muscle weakness and breathing difficulties.
Croatian: Ako bolujete od miastenije gravis, a uz to uzimate i druge antibiotike koji se zovu makrolidi (poput azitromicina, klaritromicina ili eritromicina) ili antibiotike koji se zovu fluorokinoloni (poput ofloksacina, norfloksacina i ciprofloksacina), uzimanje lijeka [Naziv lijeka] dodatno povećava rizik od mišićne slabosti i otežana disanja.
English: It is estimated that approximately 30% of colistimethate sodium is converted to colistin in healthy subjects, its clearance is dependent on creatinine clearance and as renal function decreases, a greater portion of CMS is converted to colistin.
Croatian: Procjenjuje se da se u zdravih ispitanika približno 30% kolistimetatnatrija pretvara u kolistin; njegov klirens ovisi o klirensu kreatinina, a kako se bubrežna funkcija smanjuje, veći udio KMN-a pretvara se u kolistin.
English: The use of intrathecal or intraventricular administration of colistimethate sodium in the treatment of meningitis was not systematically investigated in clinical trials and is supported by case reports only.
Croatian: Intratekalna ili intraventrikularna primjena kolistimetatnatrija u liječenju meningitisa nije sustavno istražena u kliničkim ispitivanjima te je podupiru samo prikazi slučajeva.
English: The volume of distribution of colistin in healthy subjects is low and corresponds approximately to extracellular fluid (ECF).
Croatian: Volumen distribucije kolistina u zdravih dobrovoljaca je nizak i približno odgovara izvanstaničnoj tekućini.
English: The elimination of the active colistin is incompletely characterised.
Croatian: Eliminacija aktivnoga kolistina nije u potpunosti okarakterizirana.
English: The usual daily dose in children weighing up to 40 kg is 75.000 to 150.000 units per kilogram body weight, divided into three doses.
Croatian: Uobičajena dnevna doza u djece tjelesne težine do 40 kg iznosi 75 000 do 150 000 jedinica po kilogramu tjelesne težine, a primjenjuje se u tri zasebne doze.
English: The data supporting the dose regimen in paediatric patients are very limited.
Croatian: Podaci koji podupiru režim doziranja u pedijatrijskih bolesnika vrlo su ograničeni.
English: Note: The following intrathecal and intraventricular administration posology recommendations should be included in the SmPC as the current pharmaceutical formulation of all products included in this procedure is suitable for these routes of administration (based on the pH, absence of preservatives and antioxidant and volume for injection).
Croatian: Napomena: U Sažetak opisa svojstava lijeka potrebno je uključiti sljedeće preporuke za doziranje kod intratekalne i intraventrikularne primjene jer je sadašnja farmaceutska formulacija svih lijekova uključenih u ovaj postupak prikladna za te putove primjene (s obzirom na pH, odsutnost konzervansa i antioksidansa te volumen injekcije).
English: Polymyxins are selective for aerobic Gram-negative bacteria that have a hydrophobic outer membrane.
Croatian: Polimiksini selektivno djeluju na aerobne Gram-negativne bakterije koje imaju hidrofobnu vanjsku membranu
English: The dose is expressed in the US, and other parts of the world, as milligrams of colistin base activity (mg CBA).
Croatian: SAD-u i drugim dijelovima svijeta doza se izražava u miligramima aktivnosti kolistinske baze (mg CBA).
English: Therapeutic guidelines should be adhered to.
Croatian: Potrebno je pridržavati se smjernica za liječenje.
English: [Product name] is administered intravenously as a slow infusion over 30 - 60 minutes.
Croatian: [Naziv lijeka] se primjenjuje intravenski u obliku spore infuzije u trajanju od 30-60 minuta.
English: In the EU, the dose of colistimethate sodium (CMS) must be prescribed and administered only as International Units (IU).
Croatian: Europskoj uniji se doza kolistimetatnatrija (KMN) mora propisivati i primjenjivati isključivo u internacionalnim jedinicama (IU).
English: Section 4.1 Therapeutic indications
Croatian: Dio 4.1 Terapijske indikacije
English: Patients who are hypovolaemic or those receiving other potentially nephrotoxic drugs are at increased risk of nephrotoxicity from colistin (see sections 4.5 and 4.8).
Croatian: U bolesnika s hipovolemijom ili bolesnika koji primaju druge potencijalno nefrotoksične lijekove postoji povećan rizik od nefrotoksičnosti kolistina (vidjeti dijelove 4.5 i 4.8).
English: The usual daily dose in adults is 9 million units, divided into two or three doses.
Croatian: Uobičajena dnevna doza u odraslih iznosi 9 milijuna jedinica, a primjenjuje se u dvije ili tri zasebne doze.
English: Dose conversion table:
Croatian: Tablica za konverziju doze:
English: Resistant bacteria are characterised by modification of the phosphate groups of lipopolysaccharide, which become substituted with ethanolamine or aminoarabinose.
Croatian: Rezistentne bakterije karakterizira modifikacija fosfatnih skupina lipopolisaharida, čije mjesto zauzimaju etanolamin ili aminoarabinoza.
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: Kod prirodno rezistentnih Gram-negativnih bakterija, kao što su Proteus mirabilis i Burkholderia cepacia, dolazi do potpune zamjene lipidnih fosfata etanolaminom ili aminoarabinozom.
English: Intravenous colistimethate sodium does not cross the blood brain barrier to a clinically relevant extent.
Croatian: Intravenski primijenjen kolistimetatnatrij ne prolazi kroz krvno-moždanu barijeru u klinički značajnoj mjeri.
English: The information on the pharmacokinetics of colistimethate sodium (CMS) and colistin is limited.
Croatian: Informacije o farmakokinetici kolistimetatnatrija (KMN) i kolistina su ograničene.
English: In the absence of meningeal inflammation, penetration into the cerebrospinal fluid (CSF) is minimal, but increases in the presence of meningeal inflammation.
Croatian: Ako nema upale moždanih ovojnica, penetracija u cerebrospinalnu tekućinu je minimalna, ali se u slučaju upale moždanih ovojnica povećava.
English: Polymyxins have been reported to have a concentration-dependent bactericidal effect on susceptible bacteria.
Croatian: Prijavljeno je da polimiksini imaju o koncentraciji ovisan baktericidni učinak na osjetljive bakterije.
English: No-HD days: 2.25 MIU/day (2.2-2.3 MIU/day).
Croatian: Dani bez hemodijalize: 2,25 milijuna IU/dan (2,2-2,3 milijuna IU/dan).
English: The product label states the number of IU per vial.
Croatian: Na označavanju lijeka navodi se broj IU po bočici.
English: Haemodialysis and continuous haemo(dia)filtration Colistin appears to be dialyzable through conventional haemodialysis and continuous venovenous haemo(dia)filtration (CVVHF, CVVHDF).
Croatian: Čini se da se kolistin može dijalizirati standardnom hemodijalizom i kontinuiranom veno-venskom hemo(dija)filtracijom (engl. continuous venovenous haemo(dia)filtration, CVVHF, CVVHDF).
English: Older people No dose adjustments in older patients with normal renal function are considered necessary.
Croatian: Smatra se da nije potrebna prilagodba doze u starijih bolesnika s normalnom bubrežnom funkcijom.
English: [Product name] is indicated in adults and children including neonates for the treatment of serious infections due to selected aerobic Gram-negative pathogens in patients with limited treatment options (see sections 4.2, 4.4, 4.8 and 5.1).
Croatian: [Naziv lijeka] je indiciran za liječenje ozbiljnih infekcija uzrokovanih odabranim aerobnim Gram-negativnim patogenima u odraslih osoba i djece, uključujući novorođenčad, kod kojih su mogućnosti liječenja ograničene (vidjeti dijelove 4.2, 4.4, 4.8 i 5.1).
English: Twice daily dosing is recommended.
Croatian: Preporučuje se doziranje dvaput na dan.
English: Intrathecal and intraventricular administration
Croatian: Intratekalna i intraventrikularna primjena
English: 4.5-5.5 MIU
Croatian: 4,5-5,5 milijuna IU
English: Both CMS and colistin display linear PK in the clinically relevant dose range.
Croatian: I KMN i kolistin pokazuju linearnu farmakokinetiku u klinički relevantnom rasponu doza.
English: The usual dose for children less than 2 years old is 0.5-1 million units twice daily (maximum 2 million units per day).
Croatian: Uobičajena doza za djecu mlađu od 2 godine iznosi 0,5-1 milijun jedinica dvaput na dan (maksimalno 2 milijuna jedinica na dan).
English: As the development of resistance to intravenous colistin has been reported in particular when it is used as a monotherapy, co- administration with other antibacterial should also be considered in order to prevent the emergence of resistance.
Croatian: Budući da je prijavljen razvoj rezistencije na intravenski primijenjen kolistin, osobito kada se primjenjuje u monoterapiji, istodobnu primjenu s drugim antibakterijskim lijekom potrebno je razmotriti i radi sprječavanja razvoja rezistencije.
English: Monitoring should be performed for perioral paraesthesia and paraesthesia in the extremities, which are signs of overdose (see section
Croatian: Potrebno je pratiti moguću pojavu perioralne parestezije i parestezije u ekstremitetima, koje su znakovi predoziranja (vidjeti dio 4.9).
English: Firm dose recommendations cannot be made.
Croatian: Ne mogu se dati definitivne preporuke za doziranje.
English: HD days: 3 MIU/day on haemodialysis days, to be given after the HD session.
Croatian: Dani hemodijalize: doza od 3 milijuna IU/dan na dane kada se provodi hemodijaliza, koja se primjenjuje nakon hemodijalize.
English: There are no data regarding the use or magnitude of a loading dose in critically ill children.
Croatian: Nema podataka o primjeni ni visini udarne doze u kritično bolesne djece.
English: Section 5.2 Pharmacokinetic properties
Croatian: Dio 5.2 Farmakokinetička svojstva
English: [Product name] is given as an inhalation to treat chronic chest infections in patients with cystic fibrosis.
Croatian: [Naziv lijeka] primjenjuje se inhalacijom (udisanjem) za liječenje kroničnih plućnih infekcija u bolesnika s cističnom fibrozom.
English: The dose of colistimethate sodium should be adjusted according to creatinine clearance (see section 4.2).
Croatian: Dozu kolistimetatnatrija potrebno je prilagoditi sukladno klirensu kreatinina (vidjeti dio 4.2).
English: The dose to be administered and the treatment duration should take into account the severity of the infection as well as the clinical response.
Croatian: Pri određivanju doze i trajanja liječenja potrebno je uzeti u obzir težinu infekcije i klinički odgovor.
English: There are extremely limited data from population PK studies from very small numbers of patients on renal replacement therapy.
Croatian: Dostupni su vrlo ograničeni podaci iz populacijskih farmakokinetičkih ispitivanja prikupljeni u vrlo malog broja bolesnika koji su primali nadomjesno liječenje bubrežne insuficijencije.
English: Polymyxins work by damaging the cell membrane and the resulting physiological effects are lethal to the bacterium.
Croatian: Polimiksini djeluju tako da razaraju staničnu membranu, a fiziološki učinci koji pritom nastaju smrtonosni su za bakteriju.
English: Colistin is a cyclic polypeptide antibacterial agent belonging to the polymyxin group.
Croatian: Kolistin je ciklički polipeptidni antibakterijski lijek koji pripada skupini polimiksina.
English: It is important to consider this diagnosis in patients who develop diarrhoea during or after the use of colistimethate sodium (see section 4.8).
Croatian: Važno je razmotriti tu dijagnozu u bolesnika u kojih se tijekom ili nakon primjene kolistimetatnatrija pojavi proljev (vidjeti dio 4.8).
English: 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).
Croatian: Istodobno liječenje kolistimetatnatrijem i makrolidima poput azitromicina i klaritromicina ili fluorokinolonima poput norfloksacina i ciprofloksacina mora se provoditi uz oprez u bolesnika s miastenijom gravis (vidjeti dio 4.4).
English: Renal maturity should be taken into consideration when selecting the dose.
Croatian: Pri odabiru doze potrebno je uzeti u obzir zrelost bubrega.
English: 125.000 IU/day Intrathecally administered doses should not exceed those recommended for intraventricular use.
Croatian: Intratekalno primijenjene doze ne smiju biti veće od onih preporučenih za intraventrikularnu primjenu.
English: Colistimethate sodium is known to reduce the presynaptic release of acetyl-choline at the neuromuscular junction and should be used in patients with myasthenia gravis with the greatest caution and only if clearly needed.
Croatian: Poznato je da kolistimetatnatrij smanjuje presinaptičko otpuštanje acetilkolina na neuromuskularnom spoju i stoga ga se u bolesnika s miastenijom gravis mora primjenjivati uz najveći oprez i samo ako je to posve neophodno.
English: Due to the effects of colistin on the release of acetylcholine, non-depolarising muscle relaxants should be used with caution in patients receiving colistimethate sodium as their effects could be prolonged (see section 4.4).
Croatian: Zbog učinaka kolistina na otpuštanje acetilkolina, nedepolarizirajući mišićni relaksansi se u bolesnika koji primaju kolistimetatnatrij moraju primjenjivati uz oprez jer bi njihovi učinci mogli biti produljeni (vidjeti dio 4.4).
English: The usual dose for adults, adolescents and children aged 2 years or older is 1-2 million units two to three times per day (maximum 6 million units per day).
Croatian: Uobičajena doza za odrasle, adolescente i djecu u dobi od 2 ili više godina iznosi 1-2 milijuna jedinica dva do tri puta na dan (maksimalno 6 milijuna jedinica na dan).
English: Colistimethate sodium should be used with extreme caution in patients with porphyria.
Croatian: Kolistimetatnatrij se mora primjenjivati uz izniman oprez u bolesnika s porfirijom.
English: 5.5-7.5 MIU
Croatian: 5,5-7,5 milijuna IU
English: Peak plasma concentrations of colistin have been shown to occur with a delay of up to 7 hours after administration of colistimethate sodium in critically ill patients.
Croatian: Pokazalo se da se vršne koncentracije kolistina u plazmi mogu dosegnuti i do 7 sati kasnije nakon primjene kolistimetatnatrija u kritičnih bolesnika.
English: The dose should be based on lean body weight.
Croatian: Doza se mora temeljiti na tjelesnoj težini bez masnog tkiva.
English: The loading dose applies to patients with normal and impaired renal functions including those on renal replacement therapy.
Croatian: Udarna doza vrijedi za bolesnike s normalnom i one s oštećenom bubrežnom funkcijom, uključujući bolesnike koji primaju nadomjesno liječenje bubrežne insuficijencije.
English: R>4 mg/L a Breakpoints apply to dosage of 2-3 MIU x 3.
Croatian: R>4 mg/l a Granične vrijednosti odnose se na dozu od 2-3 milijuna IU x 3. Može biti potrebna udarna doza (9 milijuna IU).
English: Caution is advised when administering colistimethate sodium in these patients.
Croatian: Preporučuje se oprez kada se kolistimetatnatrij primjenjuje u tih bolesnika.