FrancophonIA/ELRC3.0 huggingface dataset:
English: The proportion of children with neurological conditions, such as autism spectrum disorder (ASD) and Smith-Magenis syndrome, who also have insomnia is high and not many treatments are available.
Slovenian: Delež otrok z nevrološkimi boleznimi, kot sta motnja avtističnega spektra (ASD) in sindrom SmithMagenis, ki hkrati trpijo tudi zaradi nespečnosti, je velik, na voljo pa ni veliko zdravil.
English: Other information about Slenyto
Slovenian: Druge informacije o zdravilu Slenyto
English: What benefits of Slenyto have been shown in studies?
Slovenian: Kakšne koristi zdravila Slenyto so se pokazale v študijah?
English: Because Slenyto releases melatonin slowly over a few hours, it mimics the natural production of melatonin in the body.
Slovenian: Ker se melatonin iz zdravila Slenyto sprošča počasi, v obdobju nekaj ur, posnema naravno nastajanje melatonina v telesu.
English: The dose can be increased up to a maximum of 10 mg if the medicine is not working well enough.
Slovenian: Če zdravilo ne učinkuje dovolj dobro, se odmerek lahko poveča do največ 10 mg.
English: The active substance in Slenyto, melatonin, is a naturally occurring hormone, which is normally produced by a gland in the brain called the pineal gland.
Slovenian: Učinkovina v zdravilu Slenyto, melatonin, je naravni hormon, ki ga običajno proizvaja žleza v možganih, imenovana češerika.
English: Slenyto has been shown to be effective at improving sleeping time in children and adolescents with neurological conditions, including autism spectrum disorder and Smith-Magenis syndrome.
Slovenian: Dokazali so, da je zdravilo Slenyto učinkovito pri izboljšanju časa spanja pri otrocih in mladostnikih z nevrološkimi boleznimi, vključno z motnjo avtističnega spektra in sindromom Smith-Magenis.
English: Slenyto is used after other measures such as keeping to a regular sleeping routine have not worked.
Slovenian: Zdravilo Slenyto se uporablja, ko drugi ukrepi, kot so redna spalna rutina, niso učinkoviti.
English: In a main study of 125 patients, those given Slenyto over 13 weeks slept on average for 51 extra minutes of sleep a night compared with and 19 extra minutes for those given placebo (a dummy treatment).
Slovenian: V glavni študiji s 125 bolniki so bolniki, ki so 13 tednov prejemali zdravilo Slenyto, spali povprečno 51 minut na noč več, bolniki, ki so prejemali placebo (zdravilo brez učinkovine), pa 19 minut več.
English: Slenyto increases levels of melatonin in the blood, helping them to sleep.
Slovenian: Zdravilo Slenyto poveča ravni melatonina v krvi in tako bolnikom pomaga zaspati.
English: How is Slenyto used?
Slovenian: Kako se zdravilo Slenyto uporablja?
English: Slenyto has been shown to improve sleeping times in these patients, with patients taking Slenyto sleeping for an extra 51 minutes a night compared with an extra 19 minutes with placebo.
Slovenian: Dokazali so, da zdravilo Slenyto pri teh bolnikih izboljša čas spanja, saj so bolniki, ki so prejemali zdravilo Slenyto, spali 51 minut več, bolniki, ki so prejemali placebo, pa 19 minut več.
English: How does Slenyto work?
Slovenian: Kako zdravilo Slenyto deluje?
English: 16 December 2014 EMA/785229/2014 corr1
Slovenian: 16. december 2014 EMA/785229/2014
English: The review of polymyxin-based medicines was initiated on 16 September 2013 at the request of the European Commission, under Article 31 of Directive 2001/83/EC.
Slovenian: Pregled zdravil, ki vsebujejo polimiksine, se je začel 16. septembra 2013 na zahtevo Evropske komisije v skladu s členom 31 Direktive 2001/83/ES.
English: Currently, products containing colistimethate sodium for use by injection or by inhalation as a solution or as a mist (nebulised) are approved under various trade names in Austria, Belgium, Bulgaria, Croatia, the Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Malta, Netherlands Poland, Portugal, Romania, Slovakia, Spain, Sweden and United Kingdom.
Slovenian: Trenutno so zdravila, ki vsebujejo natrijev kolistimetat in se uporabljajo z injiciranjem ali v obliki raztopine ali meglice (s pomočjo nebulatorja) za inhaliranje, pod različnimi trgovskimi imeni odobrena v Avstriji, Belgiji, Bolgariji, na Hrvaškem, v Češki republiki, na Danskem, v Estoniji, Franciji, Nemčiji, Grčiji, na Madžarskem, Irskem, v Italiji, Luksemburgu, na Malti, Nizozemskem, Poljskem, Portugalskem, v Romuniji, na Slovaškem, v Španiji, na Švedskem in v Združenem kraljestvu.
English: • Patients who have any questions about their treatment should consult their doctor or pharmacist.
Slovenian: • Bolniki, ki imajo kakršna koli vprašanja o zdravljenju, naj se posvetujejo z zdravnikom ali farmacevtom.
English: • Dosage should be in line with relevant treatment guidelines.
Slovenian: • Odmerjanje mora biti skladno z ustreznimi smernicami za zdravljenje.
English: The CHMP opinion was forwarded to the European Commission, which issued a final decision valid throughout the EU on 16 December 2014.
Slovenian: Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je 16. decembra 2014 izdala končni sklep, ki velja za celotno EU.
English: However, it was considered that in the interim the product information should be updated throughout the EU to reflect what was currently known.
Slovenian: Vendar pa je bilo ocenjeno, da je treba v tem času posodobiti informacije o zdravilu po vsej EU, da se vključi vse, kar je trenutno znanega.
English: Critically ill patients should be given a higher starting dose (loading dose) to provide an effective level of the antibiotic in the body more quickly.
Slovenian: Kritično bolnim bolnikom je treba predpisati večji začetni (polnilni) odmerek, da se hitreje zagotovi učinkovita raven antibiotika v telesu.
English: Recommendations issued for safe use in patients with serious infections resistant to standard antibiotics
Slovenian: Izdana so bila priporočila za varno uporabo pri bolnikih z resnimi okužbami, odpornimi proti standardnim antibiotikom
English: To address the differences in the way in which the strength of colistimethate sodium and colistin are expressed in the EU and in other regions such as the USA and Australia, which has led to errors in reporting in the medical literature and could potentially lead to serious medication errors, the following table will be included in the product information:
Slovenian: Da bi odpravili razlike v načinu izražanja jakosti natrijevega kolistimetata in kolistina v EU in na drugih območjih, kot so ZDA in Avstralija, zaradi katerih je prihajalo do napak pri poročanju v medicinski literaturi in ki bi lahko povzročile resne napake pri zdravljenju, bo v informacije o zdravilu vključena naslednja razpredelnica:
English: Colistin-base activity (CBA) (mg)1
Slovenian: Aktivnost kolistinske baze (mg)1
English: The Agency's recommendations are based on a review of the available clinical, pharmacological and pharmacokinetic data, although significant gaps still exist, particularly with regard to the pharmacokinetics in special populations such as children and patients with renal impairment.
Slovenian: Priporočila agencije temeljijo na pregledu razpoložljivih kliničnih, farmakoloških in farmakokinetičnih podatkov, čeprav precej podatkov še vedno manjka, zlasti tistih o farmakokinetiki pri posebnih populacijah, kot so otroci in bolniki z okvaro ledvic.
English: Polymyxin-based products have been available since the 1960s, but their use quickly decreased due to the availability of antibiotics with fewer potential side effects.
Slovenian: Zdravila, ki vsebujejo polimiksine, so na voljo od šestdesetih let prejšnjega stoletja, vendar se je njihova uporaba hitro zmanjšala, ko so postali na voljo antibiotiki, ki imajo manj možnih neželenih učinkov.
English: The Committee recommended that doses should always be expressed in international units (IU) but because doses of colistimethate sodium can be expressed in different ways a conversion table should be included in the product information.
Slovenian: Odbor je priporočil, da se odmerki vedno izražajo v mednarodnih enotah (i.e.), ker pa so odmerki natrijevega kolistimetata lahko izraženi na različne načine, mora biti v informacije o zdravilu vključena razpredelnica za pretvorbo.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) reviewed the available data about the pharmacokinetics, effectiveness and safety of these medicines.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je pregledal razpoložljive podatke o farmakokinetiki, učinkovitosti in varnosti teh zdravil.
English: European Medicines Agency completes review of polymyxin-based medicines
Slovenian: Evropska agencija za zdravila zaključila pregled zdravil, ki vsebujejo polimiksine
English: This has led to a resurgence in recent years in the use of polymyxins in patients with few other options.
Slovenian: Zaradi tega se je v zadnjih letih ponovno povečala uporaba polimiksinov pri bolnikih, ki imajo malo drugih možnosti.
English: 1 Nominal potency of the drug substance = 12.500 IU/mg
Slovenian: Nominalna jakost zdravilne učinkovine zdravila = 12.500 i.e./mg.
English: The review of these data was conducted by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which considered them and formulated the Agency's final opinion.
Slovenian: Pregled teh podatkov je opravil Odbor za zdravila za uporabo v humani medicini (CHMP), pristojen za vprašanja, povezana z zdravili za uporabo v humani medicini, ki je proučil podatke in oblikoval končno mnenje agencije.
English: On 23 October 2014 the European Medicines Agency (EMA) completed a review of the safety and effectiveness of products containing the antibiotics colistin or colistimethate sodium (known as polymyxins) and recommended changes to their product information to ensure safe use in the treatment of serious infections that are resistant to standard antibiotics.
Slovenian: Evropska agencija za zdravila (EMA) je 23. oktobra 2014 zaključila pregled varnosti in učinkovitosti zdravil, ki vsebujejo antibiotik kolistin ali natrijev kolistimetat (znana kot polimiksina), ter priporočila spremembe informacij o zdravilu za zagotovitev varne uporabe pri zdravljenju resnih okužb, ki so odporne proti standardnim antibiotikom.
English: The recommended dose in adults is 1 to 2 million IU given 2 to 3 times a day, and in children 0.5 to 1 million IU twice daily, adjusted according to the severity of the condition and the response.
Slovenian: Priporočeni odmerek za odrasle je od 1 do 2 milijona i.e., ki se daje 2- do 3-krat na dan, za otroke pa od 0,5 do 1 milijona i.e. dvakrat na dan, prilagojeno glede na resnost bolezni in odziv.
English: The European Commission therefore requested the EMA to review the available data and make recommendations on whether the marketing authorisations for these medicines should be changed and the product information amended appropriately.
Slovenian: Evropska komisija je zato zaprosila Evropsko agencijo za zdravila, naj pregleda razpoložljive podatke in poda priporočila o tem, ali bi bilo treba spremeniti dovoljenja za promet s temi zdravili in ustrezno posodobiti informacije o zdravilu.
English: • In children, the suggested dose is 75,000 to 150,000 IU/kg daily, in 3 divided doses.
Slovenian: • Predlagani odmerek za otroke je od 75.000 do 150.000 i.e./kg na dan v 3 deljenih odmerkih.
English: Although data were very limited, the Committee recommended doses for use in patients with kidney problems and in children, and provided guidance on dosage in adults when given directly into fluid surrounding the brain or spinal cord (intrathecal or intraventricular injection).
Slovenian: Čeprav so bili podatki zelo omejeni, je Odbor priporočil odmerke za uporabo pri bolnikih, ki imajo težave z ledvicami, in otrocih ter podal smernice za odmerjanje pri odraslih, ki zdravilo prejmejo neposredno v tekočino, ki obdaja možgane ali hrbtenjačo (intratekalno ali intraventrikularno injiciranje).
English: Research currently underway may provide further information on pharmacodynamics and pharmacokinetics of these medicines to improve the evidence-base behind any dose recommendations.
Slovenian: Raziskava, ki trenutno poteka, bi lahko zagotovila dodatne podatke o farmakodinamiki in farmakokinetiki teh zdravil, s katerimi bi okrepili dokaze, na katerih temeljijo vsa priporočila za odmerjanje.
English: • The product information for medicines containing colistimethate sodium will be updated as required to take these recommendations into account.
Slovenian: • Informacije o zdravilu za zdravila, ki vsebujejo natrijev kolistimetat, bodo ustrezno posodobljene, tako da se bodo upoštevala ta priporočila.
English: Based on the limited available evidence the recommended dose in adults is 9 million IU daily in 2 or 3 divided doses as a slow intravenous infusion; in critically ill patients a loading dose of 9 million IU should be given.
Slovenian: Glede na omejene razpoložljive dokaze je priporočeni odmerek za odrasle 9 milijonov i.e. na dan v 2 ali 3 deljenih odmerkih, ki se dajejo s počasno intravensko infuzijo; kritično bolnim bolnikom je treba dati polnilni odmerek 9 milijonov i.e.
English: In addition, colistimethate sodium has been approved in the EU for inhalation as a dry powder under the trade name Colobreathe.
Slovenian: Poleg tega je natrijev kolistimetat v EU odobren tudi v obliki suhega praška za inhaliranje pod trgovskim imenom Colobreathe.
English: • The available information on colistimethate sodium has been reviewed and recommendations have been made on its safe use and appropriate dosage.
Slovenian: • Opravljen je bil pregled razpoložljivih podatkov o natrijevem kolistimetatu in podana priporočila o njegovi varni uporabi in ustreznem odmerjanju.
English: However, current experience has raised concerns that the existing product information, in particular relating to dosing and the way the medicine is handled in the body (pharmacokinetics), might need updating.
Slovenian: Vendar pa so trenutne izkušnje vzbudile skrbi, da bi bilo morda treba posodobiti obstoječe informacije o zdravilu, zlasti v zvezi z odmerjanjem in obnašanjem zdravila v telesu (farmakokinetika).
English: Products taken by mouth (which mainly contain colistin and are not absorbed into the body in significant amounts but act locally on the gut) and those applied externally were not covered in this review.
Slovenian: Zdravila, ki se jemljejo skozi usta (in ki v glavnem vsebujejo kolistin ter se v telesu ne absorbirajo v pomembnih količinah, temveč lokalno učinkujejo na črevesje), in zdravila za zunanjo uporabo v ta pregled niso bila vključena.
English: The medicine should be given with another suitable antibiotic where possible.
Slovenian: Če je mogoče, je zdravilo treba dajati sočasno z drugim ustreznim antibiotikom.
English: • Use of intravenous colistimethate sodium together with other medications that are potentially nephrotoxic or neurotoxic should be undertaken with great caution.
Slovenian: • Pri uporabi intravenskega natrijevega kolistimetata skupaj z drugimi zdravili, ki so lahko nefrotoksična ali nevrotoksična, je potrebna izjemna previdnost.
English: Products containing colistin are available for use by mouth or for external application but are not included in this review, as they are not considered to produce significant amounts of the active substance in the body.
Slovenian: Zdravila, ki vsebujejo kolistin, so na voljo za uporabo skozi usta ali zunanjo uporabo, vendar niso bila vključena v ta pregled, saj ne povzročijo pomembnih količin zdravilne učinkovine v telesu.
English: Where appropriate, adult doses of 125,000 IU for intraventricular administration and no more than this for intrathecal administration are recommended.
Slovenian: Kadar je to primerno, se za odrasle priporočajo odmerki 125.000 i.e. za intraventrikularno dajanje in največ tolikšni tudi za intratekalno dajanje.
English: A parallel review under Article 5(3) of Regulation (EC) No 726/2004 is currently also under way, looking at the quality of the products and the way the potency of colistimethate sodium is measured and tested, and may result in further changes to the product information once complete.
Slovenian: Trenutno poteka tudi vzporeden pregled v skladu s členom 5(3) Uredbe (ES) št. 726/2004, namenjen proučitvi kakovosti zdravil ter načina merjenja in preskušanja jakosti natrijevega kolistimetata, ob zaključku katerega se bodo morda v informacije o zdravilu vključile dodatne spremembe.
English: Consideration should be given to co-administration with another antibacterial agent whenever this is possible.
Slovenian: Razmisliti je treba o sočasni uporabi z drugim antibiotikom, kadar je to mogoče.
English: Colistin and its prodrug colistimethate sodium are the only polymyxins approved for clinical use in the EU, and the review was limited to products used by injection or inhalation (all formulated as colistimethate sodium).
Slovenian: Kolistin in njegovo predzdravilo natrijev kolistimetat sta edina polimiksina, ki sta odobrena za klinično uporabo v EU, pregled pa je bil omejen na zdravila, ki se uporabljajo z injiciranjem ali inhaliranjem (vsa v obliki natrijevega kolistimetata).
English: (Products for inhalation as a dry powder have a different dosage and distribution in the body, and were not affected by the conclusions of the review.)
Slovenian: (Zdravila v obliki suhega praška za inhaliranje se drugače odmerjajo in porazdelijo v telesu, zato zaključki pregleda zanje ne veljajo.)
English: Polymyxins are a group of antibiotics that includes colistin and colistimethate sodium (a ‘prodrug' that is converted to colistin in the body), which have been available in the EU since the 1960s for the treatment of susceptible infections.
Slovenian: Polimiksini so skupina antibiotikov, med katere spadata tudi kolistin in natrijev kolistimetat („predzdravilo“, ki se v telesu pretvori v kolistin) in ki so od šestdesetih let prejšnjega stoletja v EU na voljo za zdravljenje zanje občutljivih okužb.
English: Due in part to this limited use, colistimethate sodium has retained activity against a number of bacteria which have become resistant to commonly used antibiotics.
Slovenian: Natrijev kolistimetat je deloma tudi zaradi te omejene uporabe ohranil učinkovitost proti številnim bakterijam, ki so postale odporne proti pogosto uporabljanim antibiotikom.
English: • Doses should always be expressed in IU of colistimethate sodium.
Slovenian: • Odmerki morajo biti vedno izraženi v i.e. natrijevega kolistimetata.
English: • Intravenous colistimethate sodium does not cross the blood-brain barrier to a significant extent.
Slovenian: • Intravenski natrijev kolistimetat ne prehaja dovolj skozi krvno-možgansko pregrado.
English: • Colistin and colistimethate sodium are older antibiotics (belonging to the class called polymyxins) that are sometimes used for infections that have become resistant to newer treatments.
Slovenian: • Kolistin in natrijev kolistimetat sta starejša antibiotika (iz razreda zdravil, imenovanih polimiksini), ki se včasih uporabljata za okužbe, ki so postale odporne proti novejšim zdravilom.
English: Colistimethate sodium is given by injection or inhaled, and becomes colistin inside the body.
Slovenian: Natrijev kolistimetat se daje z injiciranjem ali inhaliranjem in se v telesu pretvori v kolistin.
English: • Injection or infusion (drip) of colistimethate sodium should only be used to treat serious infections in patients with few other treatment options, normally combined with another antibiotic.
Slovenian: • Natrijev kolistimetat se lahko z injiciranjem ali infundiranjem (kapalno infuzijo) daje samo za zdravljenje resnih okužb pri bolnikih, ki imajo malo drugih možnosti zdravljenja, običajno v kombinaciji z drugim antibiotikom.
English: Colistimethate sodium (mg)
Slovenian: Natrijev kolistimetat (mg)
English: • Intravenous colistimethate sodium is indicated in adults and children including neonates for the treatment of serious infections due to aerobic Gram-negative pathogens in patients with limited treatment options.
Slovenian: • Intravenski natrijev kolistimetat je indiciran pri odraslih in otrocih, vključno z novorojenčki, za zdravljenje resnih okužb, ki jih povzročajo aerobni gramnegativni patogeni, kadar imajo bolniki omejene možnosti zdravljenja.
English: A parallel review is currently underway, looking at the quality of the products and the way the potency of colistimethate sodium is measured and tested, and may result in further changes to the product information once complete.
Slovenian: Trenutno poteka vzporeden pregled, namenjen proučitvi kakovosti zdravil ter načina merjenja in preskušanja jakosti natrijevega kolistimetata, ob zaključku katerega se bodo morda v informacije o zdravilu vključile dodatne spremembe.
English: The review considered products given by injection or inhaled as a liquid into the lungs (systemic use) containing colistimethate sodium, which is converted to the active substance colistin in the body.
Slovenian: V pregled so bila vključena zdravila, ki se dajejo z injiciranjem ali se v obliki tekočine inhalirajo v pljuča (sistemska uporaba) in vsebujejo natrijev kolistimetat, ki se v telesu pretvori v zdravilno učinkovino kolistin.
English: Colistimethate sodium (IU)
Slovenian: Natrijev kolistimetat (i.e.)
English: • When given by inhalation, colistimethate sodium solutions may be used for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adults and children with cystic fibrosis.
Slovenian: • Raztopine natrijevega kolistimetata, ki se dajejo z inhaliranjem, se lahko uporabljajo za obvladovanje kroničnih pljučnih okužb, ki jih povzroča Pseudomonas aeruginosa, pri odraslih in otrocih s cistično fibrozo.
English: CHMP concluded that colistimethate sodium may also be given by inhalation or in a nebuliser to treat ongoing (chronic) infections with the bacterium Pseudomonas aeruginosa in patients with cystic fibrosis.
Slovenian: Odbor CHMP je zaključil, da se natrijev kolistimetat lahko daje tudi z inhaliranjem ali z nebulatorjem za zdravljenje obstoječih (kroničnih) okužb z bakterijo Pseudomonas aeruginosa pri bolnikih s cistično fibrozo.
English: Doses should be reduced according to creatinine clearance in patients with renal impairment.
Slovenian: Pri bolnikih z okvaro ledvic je treba odmerke zmanjšati glede na očistek kreatinina.
English: The CHMP concluded that injection or infusion (drip) of colistimethate sodium should be reserved for the treatment of serious infections due to susceptible bacteria, in patients whose other treatment options are limited.
Slovenian: Odbor CHMP je zaključil, da se lahko natrijev kolistimetat z injiciranjem ali infundiranjem (kapalno infuzijo) daje samo za zdravljenje resnih okužb, ki jih povzročajo občutljive bakterije, pri bolnikih, pri katerih so druge možnosti zdravljenja omejene.
English: Colistimethate sodium may also be inhaled as a liquid vapour to treat lung infection in patients with cystic fibrosis.
Slovenian: Prav tako se natrijev kolistimetat lahko inhalira v obliki tekočinske pare za zdravljenje pljučne okužbe pri bolnikih s cistično fibrozo.
English: • adults and children from 6 years of age with chronic (long-term) kidney disease.
Slovenian: • odraslih in otrocih, starih šest let in več, s kronično (dolgotrajno) boleznijo ledvic.
English: • adult patients on dialysis (a technique to remove unwanted substances from the blood);
Slovenian: • odraslih bolnikih na dializi (tehniki odstranjevanja neželenih snovi iz krvi);
English: This authorisation was based on the authorisation granted to Renvela in 2009 (‘informed consent').
Slovenian: Izdaja tega dovoljenja je temeljila na dovoljenju za promet z zdravilom Renvela, ki je bilo izdano leta 2009 (uporaba dokumentacije s soglasjem).
English: Further information on Sevelamer carbonate Winthrop can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/sevelamer-carbonate-winthrop.
Slovenian: Nadaljnje informacije za zdravilo Sevelamer carbonate Winthrop so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/sevelamer-carbonate-winthrop.