natgillin/translations-raw huggingface dataset:
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.
Having reviewed all available data, the CHMP considered that CMS and colistin represent a crucial therapeutic option in the armamentarium available to prescribers in the context of the treatment of infections caused by multi-drug resistant Gram-negative pathogens.
Ko je odbor CHMP pregledal vse razpoložljive podatke, je menil, da NKM in kolistin predstavljata ključno terapevtsko možnost, ki je na voljo predpisovalcem za zdravljenje okužb, ki jih povzročajo multirezistentni gramnegativni patogeni.
• the CHMP considered that colistimethate sodium and colistin represent a crucial therapeutic option in the context of the treatment of infections caused by multi-drug resistant Gramnegative pathogens,
• odbor CHMP je menil, da natrijev kolistimetat in kolistin predstavljata ključno terapevtsko možnost za zdravljenje okužb, ki jih povzročajo multirezistentni gramnegativni patogeni;
• the CHMP considered that the risks of nephrotoxicity and neurotoxicity observed with colistin for parenteral use should be balanced against the risk of the underlying disease and the high mortality from the treated conditions and that it can be satisfactorily mitigated by warnings and recommendations in the SmPC,
• odbor CHMP je menil, da je treba tveganja nefrotoksičnosti in nevrotoksičnosti, ki so jih opazili pri kolistinu za parenteralno uporabo, pretehtati glede na tveganje osnovne bolezni in veliko umrljivost zaradi zdravljenih stanj ter da jih je mogoče zadovoljivo zmanjšati z opozorili in priporočili v povzetku glavnih značilnosti zdravila;
• the CHMP made extensive revisions to the SmPC to reflect current pharmacokinetic and pharmacodynamic data, including an update of the EUCAST breakpoints and the list of susceptible species,
• odbor CHMP je temeljito pregledal in popravil povzetke glavnih značilnosti zdravila, da odražajo trenutne farmakokinetične in farmakodinamične podatke, vključno s posodobitvijo mejnih vrednosti po EUCAST in seznamom občutljivih vrst;
In conclusion, the CHMP is of the opinion that the benefit-risk of the polymyxin-based products included in the scope of this procedure remains positive, provided that changes, as applicable, are made to their product information as set out in Annex III to the opinion.
V svojem sklepu je odbor CHMP menil, da razmerje med tveganji in koristmi zdravil, ki vsebujejo polimiksine in so vključena v ta postopek, ostaja pozitivno, če se v informacije o zdravilu vnesejo spremembe, navedene v Prilogi III k temu mnenju, kot je primerno.
The posology and method of administration section was also revised in its entirety, for all patient subpopulations, in order to define the optimal treatment regimens for achieving plasma concentrations above the critical minimal inhibitory concentrations.
Da bi opredelili optimalne režime zdravljenja za doseganje koncentracij v plazmi, večjih od kritičnih minimalnih inhibitornih koncentracij, so spremenili tudi celotni poglavji o odmerjanju in načinu uporabe za vse podskupine bolnikov.
Strength Pharmaceutical Form Route of Administration
Številka EU ime jakost farmacevtska oblika pot uporabe ovojnina
These are your last remaining tablets.
To so zadnje tablete, ki jih še imate.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 June 2015
Datum prve odobritve: 19. junij 2015
The Patient alert card should contain the following key safety messages:
Kartica z opozorili za bolnika mora vsebovati naslednja ključna varnostna sporočila:
INFORMATION FOR HEALTHCARE PROFESSIONALS
INFORMACIJE ZA ZDRAVSTVENE DELAVCE
PRESCRIBER INFORMATION For more information or in case of emergency, please contact: Physician's name:
INFORMACIJE O PREDPISOVALCU Za več informacij ali v nujnem primeru se obrnite na: Ime zdravnika:
Prior to launch of Lixiana in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Pred prihodom zdravila Lixiana na trg vsake države članice se mora imetnik dovoljenja za promet z zdravilom dogovoriti o vsebini in obliki izobraževalnega programa, vključno s komunikacijskimi mediji, načini distribucije in vsemi drugimi vidiki programa, s pristojnim nacionalnim organom.
• Allergic reaction
• alergijska reakcija,
A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from therapy.
Odločiti se je treba ali prenehati z dojenjem ali prenehati oz. vzdržati se zdravljenja.
Discontinuation for surgery and other interventions
Ukinitev zaradi operacije in drugih posegov
Signature of physician:
Podpis zdravnika:
The same information is also available on the following URL: www.dspatient.eu.
Te informacije so na voljo tudi na naslednji povezavi: www.dspatient.eu.
Overall list of possible side effects:
Celoten seznam možnih neželenih učinkov:
Vaginal bleeds were reported commonly in women under the age of 50 years, while it was uncommon in women over the age of 50 years.
O vaginalnih krvavitvah so poročali pogosto pri ženskah, mlajših od 50 let, in občasno pri ženskah, starejših od 50 let.
Do not take Lixiana if you are pregnant or breast-feeding.
Ne jemljite zdravila Lixiana, če ste noseči ali dojite.
- if you have an increased risk of bleeding, as could be the case if you have any of the following conditions:
- če imate zvečano tveganje krvavitve, kar bi bilo možno, če imate katero od naslednjih bolezni:
Do not stop taking Lixiana unless advised by your doctor.
Ne prenehajte jemati zdravila Lixiana, razen če vam to svetuje zdravnik.
Lixiana 15 mg is not indicated as monotherapy, as it may result in decreased efficacy.
Zdravilo Lixiana 15 mg ni indicirano za monoterapijo, saj bi lahko prišlo do zmanjšane učinkovitosti.
Most patients (85%) should be able to achieve an INR ≥ 2.0 within 14 days of concomitant administration of Lixiana and VKA.
Večina bolnikov (85 %) bi morala biti sposobna doseči INR ≥ 2,0 v 14 dneh sočasnega zdravljenja z zdravilom Lixiana in VKA.
Lixiana is used in adults to:
Zdravilo Lixiana se pri odraslih uporablja:
Take as recommended by your doctor:
Zdravilo jemljite tako, kot vam je priporočil zdravnik:
85276 Pfaffenhofen, Bayern Germany
85276 Pfaffenhofen, Bayern Nemčija
30 mg once daily
60 mg enkrat na dan*
What Lixiana is and what it is used for 2.
Kaj je zdravilo Lixiana in za kaj ga uporabljamo 2.
The method used to estimate renal function (CrCL in mL/min) during the clinical development of Lixiana was the Cockcroft-Gault method.
Metoda, uporabljena za oceno delovanja ledvic (CrCL v ml/min) med kliničnim razvojem zdravila Lixiana,je bila Cockcroft-Gaultova metoda.
• endstage kidney disease or if you are on dialysis
• končni stadij bolezni ledvic ali če ste na dializi,
Table 10: Efficacy Results from the Hokusai-VTE Study - mITT population, overall study period
Preglednica 10: Rezultati učinkovitosti iz študije Hokusai-VTE - populacija mITT, celotno obdobje študije
• For creatinine in µmol/L:
• Za kreatinin vµmol/l:
The MAH shall ensure that in each Member State where Lixiana is marketed, all healthcare professionals who are expected to use Lixiana are provided with the following educational material:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vsaki državi članici, v kateri se bo tržilo zdravilo Lixiana, vsi zdravstveni delavci, za katere se pričakuje, da bodo uporabljali zdravilo Lixiana, prejeli naslednje izobraževalne materiale:
85276 Pfaffenhofen Germany
85276 Pfaffenhofen Nemčija
For all patients undergoing cardioversion: Confirmation should be sought prior to cardioversion that the patient has taken Lixiana as prescribed.
Za vse bolnike, pri katerih se izvaja kardioverzija: Pred kardioverzijo se je treba prepričati, da je bolnik vzel zdravilo Lixiana, kakor je bilo predpisano.