natgillin/translations-raw huggingface dataset:
Why was Vascace reviewed? 
Zakaj je bilo zdravilo Vascace pregledano?
The European Medicines Agency has completed a review of Vascace. 
Evropska agencija za zdravila je zaključila pregled zdravila Vascace.
Other sections such as those on special warnings, interactions and pregnancy and lactation were also harmonised. 
Usklajena so bila tudi druga poglavja, kot na primer poglavje s posebnimi opozorili, interakcijami ter poglavje o nosečnosti in dojenju.
It is used to treat hypertension and long-term heart failure (inability of the heart to pump enough blood around the body). 
Uporablja se za zdravljenje hipertenzije in dolgotrajnega srčnega popuščanja (nezmožnost srca, da črpa zadostno količino krvi po telesu).
The reduced blood pressure also helps patients with heart failure, because it is easier for the heart to pump out blood if the pressure in the blood vessels is not too high. 
Znižan krvni tlak pomaga tudi bolnikom s srčnim popuščanjem, saj srce lažje črpa kri, kadar tlak v krvnih žilah ni previsok.
It blocks the action of the enzyme ACE, which is responsible for the production of a hormone in the body called angiotensin II. 
Zavira delovanje encima ACE, ki je odgovoren za tvorjenje telesnega hormona, imenovanega angiotenzin II.
This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed. 
Zaradi tega je med državami članicami prišlo do razhajanj glede uporabe zdravila, kar je razvidno iz razlik v povzetkih glavnih značilnosti zdravila, označevanju in navodilih za uporabo v državah, kjer je zdravilo na trgu.
It must not be used in patients with angioedema (swelling beneath the skin) associated with previous treatment with ACE inhibitor or in patients with hereditary or idiopathic angioedema. 
Ne sme se uporabljati pri bolnikih z angioedemom (podkožnim otekanjem), povezanim s predhodnim zdravljenjem z zaviralci ACE ali pri bolnikih z dednim ali idiopatskim angioedemom.
If this dose is well tolerated by the patient, it can be increased to 1 or 2.5 mg once a day. 
Če bolnik ta odmerek dobro prenaša, se odmerek lahko poveča na 1 ali 2,5 mg enkrat na dan.
The CHMP agreed that Vascace should be used for the treatment of hypertension and chronic heart failure. 
CHMP se je strinjal, da se zdravilo Vascace lahko uporablja za zdravljenje hipertenzije in kroničnega srčnega popuščanja.
What is Vascace? 
Kaj je zdravilo Vascace?
A lower starting dose of 0.5 mg is recommended for hypertension in patients with a highly activated ‘renin-angiotensin-aldosterone system' as they may experience an excessive drop in blood pressure. 
Manjši začetni odmerek 0,5 mg se priporoča pri zdravljenju hipertenzije pri bolnikih z močno aktiviranim „sistemom renin-angiotenzin-aldosteron“, saj pri njih lahko pride do prekomernega padca krvnega tlaka.
For hypertension, the recommended starting dose is 1 mg per day, which can be adjusted depending on how the patient's blood pressure responds. 
Priporočeni začetni odmerek pri zdravljenju hipertenzije je 1 mg na dan, ki pa se lahko prilagodi glede na odziv bolnikovega krvnega tlaka.
The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU. 
CHMP je ob upoštevanju predloženih podatkov in znanstvene razprave v odboru menil, da je treba povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo uskladiti po vsej EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Vascace in the European Union (EU). 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da je treba v Evropski uniji (EU) uskladiti podatke o predpisovanju zdravila Vascace.
By blocking the production of this hormone, cilazapril allows the blood vessels to widen, reducing the blood pressure. 
Cilazapril z zaviranjem tvorjenja tega hormona omogoča širjenje krvnih žil ter s tem nižanje krvnega tlaka.
The Committee recommended that Vascace should not be used in patients who are hypersensitive (allergic) to cilazapril or to any other ingredients of the product, or to other ACE inhibitors. 
Odbor je priporočil, da zdravila Vascace ne smejo uporabljati bolniki, ki utegnejo biti preobčutljivi za (alergični na) cilazapril ali katero koli drugo sestavino zdravila ali druge zaviralce ACE.
Vascace is a medicine that contains the active substance cilazapril. 
Vascace je zdravilo, ki vsebuje zdravilno učinkovino cilazapril.
On 16 September 2009, European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Vascace in the EU. 
Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Vascace v EU, je dne 16. septembra 2009 zadevo napotila na CHMP.
For heart failure, the recommended starting dose is 0.5 mg once a day for one week. 
Priporočeni začetni odmerek pri zdravljenju srčnega popuščanja je 0,5 mg enkrat na dan en teden.
The active substance in Vascace, cilazapril, is an ‘angiotensin converting enzyme (ACE) inhibitor'. 
Zdravilna učinkovina v zdravilu Vascace, cilazapril, je „zaviralec angiotenzinske konvertaze (ACE)“.
Vascace was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)). 
Usklajevalna skupina za postopek z medsebojnega priznavanja in decentralizirane postopke za zdravila za uporabo v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Vascase potrebno usklajevanje.
Company responses provided on: 28 December 2009, 22 March 2010 Opinion date: 
Odgovori družbe, poslani dne:
• Do not store below 4°C. 
• Ne shranjujte pri temperaturi pod 4°C.
Flexible PVC container holding 1.5, 2.0 or 2.5 litres. 
Mehke PVC vrečke po 1,5, 2,0 ali 2,5 litra.
12 months (for medicinal products manufactured at Alliston, Canada and North Cove, USA only). 
12 mesecev (samo za zdravila proizvedena v Allistonu, Kanada in North Cove, ZDA).
The Lineo connector contains iodine. 
Lineo konektor vsebuje jod.
6.5 Nature and Contents of Container 
6.5 Vrsta ovojnine in vsebina
The lineo connector that may equip the Y transfer line of the twin bag, contains 10.5% of Povidone iodine ointment 
Lineo konektor, ki lahko opremi Y cevje dvojne vrečke, vsebuje 10,5% povidon jodovo mazilo.
How to store EXTRANEAL 
Shranjevanje zravila EXTRANEAL
• Store in the original package. 
• Shranjujte v originalni ovojnini.
Changes are shown as greyed boxed wording 
Spremembe so prikazane v sivo obarvanem delu teksta.
Summary of Product Characteristics 
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
The shelf life of the product as packaged for sale is 24 months 12 months (for medicinal products manufactured at Alliston, Canada and North Cove, USA only). 
Rok uporabnosti zdravila v prodajnem pakiranju je 24 mesecev 12 mesecev (samo za zdravila proizvedena v Allistonu, Kanada in North Cove, ZDA).
The product, once removed from its overpouch, should be used immediately 
Ko zdravilo vzamete iz zunanjega ovoja, ga morate takoj uporabiti.
Not all configurations may be marketed. 
Na trgu ni prisotnih vseh oblik pakiranja.
• Dispose EXTRANEAL as you have been trained 
• Zdravilo EXTRANEAL odstranjujte, kakor so vas poučili.
Amendments to be included in the relevant sections of the summary of product characteristics and package leaflets for Dianeal PD4 and Extraneal, as applicable. 
Priloge, ki se bodo v skladu z ustreznostjo, vključile k posameznim poglavjem Povzetka glavnih značilnosti zdravila in Navodila za uporabo za Dianeal in Extraneal.
The date is stated on the carton label and on the bag after the abbreviation Exp. and the symbol . 
• Zdravila EXTRANEAL ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki škatle in na vrečki poleg oznake Exp. in simbola .
Twin bag (lineo connector) Not all pack sizes may be marketed. 
4 vrečke na škatlo dvojna vrečka (lineo konektor) Na trgu ni vseh navedenih pakiranj.
Amendments to the relevant sections of the summaries of product characteristics and package leaflets 
Priloga III Priloge k posameznim poglavjem povzetka glavnih znacilnosti zdravila in navodila za uporabo
• Keep out of the reach and sight of children. 
• Zdravilo shranjujte nedosegljivo otrokom!
Product configuration 
NAVODILO ZA UPORABO
EXTRANEAL 5. 
1.5 l
Data was also particularly limited for paediatric patients. 
Podatki so prav tako izjemno omejeni za pediatrične bolnike.
It was agreed that colistin can be used without age restrictions, but only for the treatment of serious infections. 
Soglašal je, da se lahko kolistin uporablja brez starostnih omejitev, vendar samo za zdravljenje resnih okužb.
This is possibly because of its limited parenteral use, due to the existence of safer, less neurotoxic and nephrotoxic therapeutic options. 
To je morebitna posledica njegove omejene parenteralne uporabe zaradi varnejših, manj nevrotoksičnih in nefrotoksičnih terapevtskih možnosti.
Overall summary of the scientific evaluation of polymyxin-based products (see Annex A and Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo polimiksine (glejte Prilogo A in Prilogo I)
Polymyxins are a group of naturally occurring antibiotics produced by the bacterium Paenibacillus polymyxa. 
Polimiksini so skupina naravno prisotnih antibiotikov, ki jih proizvaja bakterija Paenibacillus polymyxa.
The scope of the procedure includes nationally-authorised medicinal products and a centrally-authorised medicinal product, Colobreathe (dry powder for inhalation), authorised in February 2012. 
Obseg postopka vključuje nacionalno odobrena zdravila in zdravilo Colobreathe (suh prašek za inhaliranje), odobreno po centraliziranem postopku februarja 2012.
In addition, differences across the world in the expression of the strength and dose of colistin products may result in medication errors and put patients at risk. 
Poleg tega lahko globalne razlike v izražanju jakosti in odmerka zdravil, ki vsebujejo kolistin, povzročijo napake pri uporabi zdravila in bolnika izpostavijo tveganju.
However, data was extremely limited in certain patient populations and as a result, no firm recommendations could be made for patients with renal impairment, on renal replacement therapy or with hepatic impairment. 
Vendar so podatki za nekatere skupine bolnikov zelo omejeni, zato ni bilo mogoče pripraviti prepričljivih priporočil za bolnike z okvaro ledvic, bolnike na ledvičnem nadomestnem zdravljenju ali tiste z okvaro jeter.
The emergence of multi-drug resistant Gram-negative bacteria that cause nosocomial infections is a growing problem worldwide. 
Pojav proti več zdravilom odpornih gramnegativnih bakterij, ki povzročajo bolnišnične okužbe, je vedno večja svetovna težava.
The CHMP decided that the medical need was greatest for high dose products for parenteral and inhalation use and that the scope of the review should be limited to these medicinal products. 
Odbor CHMP je odločil, da je medicinska potreba največja pri visokoodmernih zdravilih za parenteralno ter inhalacijsko uporabo in da je treba obseg pregleda omejiti na ta zdravila.
Only polymyxin E (referred to as colistin) is approved for clinical use in the EU. 
Za klinično uporabo v EU je odobren samo polimiksin E (imenovan kolistin).
Limited therapeutic options have led to an increased clinical use of colistin, a polymyxin antibiotic developed over 50 years ago and which has retained activity against a number of multi-drug resistant pathogens. 
Omejene terapevtske možnosti so povzročile povečano klinično uporabo kolistina, polimiksinskega antibiotika, razvitega pred več kot 50 leti, ki je ohranil učinkovitost proti številnim patogenom, odpornim proti več zdravilom.
Two forms of colistin are used clinically: colistin sulphate and its microbiologically inactive prodrug, colistimethate sodium (CMS). 
Klinično se uporabljata dve obliki kolistina: kolistinijev sulfat in njegovo mikrobiološko neaktivno predzdravilo, natrijev kolistimetat (NKM).
CMS for parenteral use is indicated for the treatment of serious infections caused by Gram-negative pathogens and CMS for inhalation use is indicated for the management of chronic pulmonary infections due to P. aeruginosa in patients with cystic fibrosis. 
NKM za parenteralno uporabo je indiciran za zdravljenje resnih okužb, ki jih povzročajo gramnegativni patogeni, NKM za inhalacijsko uporabo pa za zdravljenje kroničnih pljučnih okužb, ki jih povzroča P. aeruginosa, pri bolnikih s cistično fibrozo.
Corresponding changes were made to the package leaflets. 
Navodila za uporabo so bila ustrezno spremenjena.
In its assessment, the CHMP reviewed all available data, including submissions by marketing authorisation holders during the procedure and consulted the Pharmacokinetics Working Party and the Infectious Disease Working Party. 
Pri svoji oceni je odbor CHMP pregledal vse razpoložljive podatke, vključno z dokumenti, ki so jih med postopkom predložili imetniki dovoljenj za promet z zdravilom, in se posvetoval z delovno skupino za farmakokinetiko ter delovno skupino za infekcijske bolezni.
The CHMP reviewed the optimal way of expressing the strength and dose of polymyxin-containing products and was of the opinion that given the established use of international units (IU) in EU clinical practice and in the European and British Pharmacopoeia, the EU product information for CMS should continue to be expressed in IU. 
Odbor CHMP je preveril optimalni način izražanja jakosti ter odmerka zdravil, ki vsebujejo polimiksine, in menil, da morajo biti glede na uveljavljeno uporabo mednarodnih enot (i.e.) v klinični praksi EU in evropski ter britanski farmakopeji informacije o zdravilu v EU še naprej izražene v i.e.
In particular, the CHMP considered that a loading dose should be administered, to ensure plasma concentrations above the minimum inhibitory concentration from the very first administration. 
Odbor CHMP je predvsem izpostavil, da je treba uporabiti začetni odmerek, ki bo zagotovil, da bodo koncentracije v plazmi večje od minimalne inhibitorne koncentracije že od prve uporabe naprej.
Polymyxins are currently listed among the critically important antimicrobials and in view of the importance of ensuring the availability of efficacious and safe antibiotics in order to efficiently respond to the threat posed by the spread of antimicrobial resistance, the European Commission initiated a procedure under Article 31 of Directive 2001/83/EC on 16 September 2013, requesting the CHMP to give its opinion on the benefit-risk of polymyxin-based products and on the need for regulatory measures. 
Zaradi pomembnosti zagotavljanja razpoložljivosti učinkovitih in varnih antibiotikov, ki omogočajo učinkovit odziv na grožnjo, ki jo predstavlja širjenje odpornosti proti antibiotikom, je Evropska komisija 16. septembra 2013 začela postopek v skladu s členom 31 Direktive 2001/83/ES, v katerem odbor CHMP poziva, naj poda svoje mnenje glede razmerja med tveganji in koristmi zdravil na osnovi polimiksinov ter potrebe po regulativnih ukrepih.
• the CHMP carried out a benefit-risk evaluation of polymyxin-based products under Article 31 of Directive 2001/83/EC, reviewing all available data, including responses submitted by the marketing authorisation holders during the procedure and recommendations from the Pharmacokinetics and the Infectious Disease working parties, 
• odbor CHMP je izvedel oceno razmerja med tveganji in koristmi zdravil na osnovi polimiksinov v skladu s členom 31 Direktive 2001/83/ES, pri čemer je pregledal vse razpoložljive podatke, vključno z odgovori, ki so jih med postopkom predložili imetniki dovoljenj za promet z zdravilom, in priporočili delovnih skupin za farmakokinetiko ter infekcijske bolezni;
Colistin has a relatively high level of toxicity associated with parenteral administration and CMS was therefore developed for parenteral and inhalation use. 
Kolistin ima relativno visoko raven toksičnosti, povezane s parenteralno uporabo, zato so za parenteralno in inhalacijsko uporabo razvili NKM.
• the CHMP considered that the dose and strength of polymyxin-based products should continue to be expressed in international units, 
• odbor CHMP je menil, da morata biti odmerek in jakost zdravil na osnovi polimiksinov še naprej izražena v mednarodnih enotah;
However, the CHMP introduced a dose content conversion table between CMS expressed in IU, CMS expressed in mg and CBA expressed in mg, to raise awareness of the different ways of expressing the strength and dose and to help prescribers who obtain additional information from the literature. 
Vendar je uvedel preglednico za pretvorbo odmerka med NKM, izraženim v i.e., NKM, izraženim v mg, in aktivnostjo kolistinske baze (CBA), izraženo v mg, da bi povečal pozornost glede različnih načinov izražanja jakosti ter odmerka in pomagal predpisovalcem, ki pridobivajo dodatne informacije iz literature.
As a consequence, the existing preclinical and clinical pharmacokinetic (PK) and pharmacodynamic (PD) information is limited, the product information has not been significantly updated over the years and the dosage regimens in use today are not based upon robust PK/PD data. 
Posledično so obstoječi predklinični in klinični farmakokinetični (FK) ter farmakodinamični (FD) podatki omejeni, informacije o zdravilu se niso pomembno posodobile že leta in današnji režimi odmerjanja ne temeljijo na zanesljivih FK/FD podatkih.
The Committee, as a consequence, concluded that the benefit-risk balance of the polymyxin-based products included in the scope of this procedure remains positive under normal conditions of use, taking into account the agreed changes to the product information, as applicable. 
odbor je posledično zaključil, da je razmerje med tveganji in koristmi zdravil na osnovi polimiksinov, vključenih v sklop tega postopka, še naprej pozitivno pri normalnih pogojih uporabe, če se upoštevajo dogovorjene spremembe informacij o zdravilu, kot je ustrezno.
Indeed, recent clinical experience and the medical literature point to the urgent need to update the product information, in particular the indications, the dosage recommendations and the PK/PD information, as highlighted by recent reports of suboptimal efficacy and the emergence of colistin resistance, in particular when used as monotherapy. 
Nedavne klinične izkušnje in medicinska literatura kažejo na nujno potrebo po posodobitvi informacij o zdravilu, predvsem indikacij, priporočil za odmerjanje in FK/FD podatkov, kar so izpostavili v nedavnih poročilih o suboptimalni učinkovitosti in pojavu odpornosti proti kolistinu, zlasti kadar se uporablja kot monoterapija.
Annex II Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations, as relevant 
Znanstveni zaključki in podlaga za ohranitev dovoljenj za promet z zdravilom ali spremembo pogojev dovoljenj za promet z zdravilom, kot je ustrezno
A key concern is to maintain the efficacy of colistin against multi-drug resistant pathogens and to avoid the selection of resistance arising from monotherapy and the CHMP therefore agreed recommendations for the co-administration of parenteral colistin with other antibiotics. 
Pri tem je ključno, da se vzdržuje učinkovitost kolistina proti multirezistentnim patogenom in prepreči nastanek odpornosti zaradi monoterapije, zato je odbor CHMP pripravil priporočila za sočasno uporabo parenteralnega kolistina skupaj z drugimi antibiotiki.
• the existing preclinical and clinical data and the product information including the indications, dosage recommendations and pharmacokinetic and pharmacodynamic information for polymyxin-based products in the EU are not up to date or based on robust data, as highlighted by recent reports of suboptimal efficacy and the emergence of colistin resistance, 
• obstoječi predklinični ter klinični podatki in informacije o zdravilu, vključno z indikacijami, priporočili za odmerjanje ter farmakokinetičnimi in farmakodinamičnimi podatki, za zdravila na osnovi polimiksinov v EU niso posodobljeni ali ne temeljijo na zanesljivih podatkih, kot so izpostavila nedavna poročila o suboptimalni učinkovitosti in pojavu odpornosti proti kolistinu;
Grounds for the maintenance and the variation to the terms of the marketing authorisation, as applicable 
Podlaga za ohranitev in spremembo pogojev dovoljenja za promet z zdravilom, kot je ustrezno
For Colobreathe, referred to in Annex A, the CHMP recommended the maintenance of the marketing authorisation, without any variations to the term of the marketing authorisation. 
Za zdravilo Colobreathe iz Priloge A je odbor CHMP priporočil ohranitev dovoljenja za promet z zdravilom brez sprememb pogojev dovoljenja za promet z zdravilom.
Finally, extensive revisions were made to reflect current pharmacokinetic and pharmacodynamic data, including an update of the EUCAST breakpoints and the list of susceptible species. 
Na koncu so uvedli obsežne spremembe, ki odražajo trenutne farmakokinetične in farmakodinamične podatke, vključno s posodobitvijo mejnih vrednosti po EUCAST in seznamom občutljivih vrst.
• the CHMP considered the available data to be sufficient to support revisions of the indication for both parenteral use and inhalation use medicinal products, in line with clinical experience and current therapeutic guidelines 
• odbor CHMP je menil, da so razpoložljivi podatki zadostni za podporo sprememb indikacije za zdravila za parenteralno ter inhalacijsko uporabo v skladu s kliničnimi izkušnjami in trenutnimi terapevtskimi smernicami;
The CHMP also reviewed the data on adverse events observed with the use of colistin and agreed that the use of colistin for parenteral use is associated with nephrotoxicity and neurotoxicity but considered that these risks must be balanced against the risk of the underlying disease and the high mortality from the treated conditions and that they can be satisfactorily mitigated by statements in the SmPC. 
Odbor CHMP je pregledal tudi podatke o neželenih dogodkih, opaženih pri uporabi kolistina, in soglašal, da je parenteralna uporaba kolistina povezana z nefrotoksičnostjo ter nevrotoksičnostjo, vendar je menil, da je treba ta tveganja pretehtati glede na tveganje osnovne bolezni in veliko umrljivost zaradi zdravljenih stanj ter da jih je mogoče zadovoljivo zmanjšati z navedbami v povzetku glavnih značilnosti zdravila.
Therefore, for the medicinal products referred to in Annex I, the CHMP recommended the variation to the terms of the marketing authorisation, for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III to the opinion. 
Zato je odbor CHMP za zdravila iz Priloge I priporočil spremembe pogojev dovoljenja za promet z zdravilom, za katera so ustrezna poglavja povzetka glavnih značilnosti zdravila in navodil za uporabo navedena v Prilogi III k temu mnenju.
A large number of PK/PD studies were reviewed together with data from clinical experience and the CHMP considered the available data to be sufficient to support revisions of the indication for both parenteral and inhalation use products, in line with clinical experience and current therapeutic guidelines. 
Odbor CHMP je pregledal številne FK/FD študije skupaj s podatki iz kliničnih izkušenj in menil, da so razpoložljivi podatki zadostni za podporo sprememb indikacije za zdravila za parenteralno ter inhalacijsko uporabo v skladu s kliničnimi izkušnjami in trenutnimi terapevtskimi smernicami.
Regarding the centrallyauthorised product Colobreathe, the CHMP considered the product information to be up to date, with no need for revision. 
Pri zdravilu Colobreathe, odobrenem po centraliziranem postopku, je odbor CHMP menil, da so informacije o zdravilu že posodobljene in jih ni treba spreminjati.