natgillin/translations-raw huggingface dataset:
Member States shall ensure that blood establishments, hospital blood banks, or facilities retain the data set out in Annex I for at least 30 years in an appropriate and readable storage medium in order to ensure traceability.
Države članice za namene sledljivosti zagotovijo, da transfuzijske ustanove ali transfuzijske banke v bolnišnici ali druge ustanove hranijo podatke iz Priloge I v primerni in berljivi obliki najmanj 30 let.
Notification of serious adverse reactions
Obveščanje o hudih neželenih reakcijah
Member States shall ensure that those facilities where transfusion occurs have procedures in place to retain the record of transfusions and to notify blood establishments without delay of any serious adverse reactions observed in recipients during or after transfusion which may be attributable to the quality or safety of blood and blood components.
Države članice zagotovijo, da imajo ustanove, kjer poteka transfuzija, postopke za hranjenje podatkov o transfuzijah in nemudoma obveščajo transfuzijske ustanove o kakršnih koli hudih neželenih reakcijah, ki jih opazijo pri prejemnikih med ali po transfuziji in ki jih lahko pripišemo kakovosti ali varnosti krvi in komponent krvi.
Member States shall ensure that reporting establishments have procedures in place to communicate to the competent authority as soon as known all relevant information about suspected serious adverse reactions.
Države članice zagotovijo, da imajo ustanove, ki poročajo, postopke, s katerimi kar najhitreje sporočijo pristojnemu organu vse potrebne informacije o sumu na hude neželene reakcije.
The notification formats set out in Part A and Part C of Annex II shall be used.
Uporablja se oblika obveščanja iz dela A in dela C Priloge II.
Member States shall ensure that reporting establishments:
Države članice zagotovijo, da ustanove, ki poročajo:
notify to the competent authority all relevant information about serious adverse reactions of imputability level 2 or 3, as referred to in Part B of Annex II, attributable to the quality and safety of blood and blood components;
pristojnemu organu sporočijo vse potrebne informacije o povezanosti med transfuzijo in neželenimi reakcijami stopnje 2 ali 3, ki jih lahko pripišemo kakovosti in varnosti krvi in komponent krvi, kot določa del B Priloge II;
notify the competent authority of any case of transmission of infectious agents by blood and blood components as soon as known;
obvestijo pristojni organ o vsakem prenosu povzročiteljev s krvjo prenosljivih nalezljivih bolezni takoj, ko zanj izvejo;
describe the actions taken with respect to other implicated blood components that have been distributed for transfusion or for use as plasma for fractionation;
opišejo sprejete ukrepe v zvezi z drugimi vpletenimi komponentami krvi, ki so bile razdeljene za transfuzijo ali uporabljene kot plazma za frakcioniranje;
evaluate suspected serious adverse reactions according to the imputability levels set out in Part B of Annex II;
ovrednotijo sum na hude neželene reakcije glede na stopnjo povezanosti med transfuzijo in neželenimi reakcijami iz dela B Priloge II;
complete the serious adverse reaction notification, upon conclusion of the investigation, using the format set out in Part C of Annex II;
po zaključku preiskave o hudi neželeni reakciji dopolnijo obvestilo z uporabo obrazca iz dela C Priloge II;
submit a complete report on serious adverse reactions to the competent authority on an annual basis using the format set out in Part D of Annex II.
z obrazcem iz dela D Priloge II pristojnemu organu vsako leto predložijo popolno poročilo o hudih neželenih reakcijah.
Notification of serious adverse events
Obveščanje o hudih neželenih dogodkih
Member States shall ensure that blood establishments and hospital blood banks have procedures in place to retain the record of any serious adverse events which may affect the quality or safety of blood and blood components.
Države članice zagotovijo, da imajo transfuzijske ustanove in transfuzijske banke v bolnišnicah postopke, po katerih hranijo zapise o hudih neželenih dogodkih, ki lahko vplivajo na kakovost ali varnost krvi in komponent krvi.
Member States shall ensure that reporting establishments have procedures in place to communicate to the competent authority as soon as known, using the notification format set out in Part A of Annex III, all relevant information about serious adverse events which may put in danger donors or recipients other than those directly involved in the event concerned.
Države članice zagotovijo, da imajo ustanove, ki poročajo, postopke, da takoj sporočijo pristojnemu organu z obrazcem iz dela A Priloge III vse pomembne informacije o hudih neželenih dogodkih, ki lahko ogrozijo dajalce ali prejemnike, ki niso neposredno vpleteni v zadevni dogodek.
evaluate serious adverse events to identify preventable causes within the process;
ovrednotijo hude neželene dogodke, da se med procesom odkrijejo vzroki, ki jih je mogoče preprečiti;
complete the serious adverse event notification, upon conclusion of the investigation, using the format set out in Part B of Annex III;
po zaključku preiskave dopolnijo obvestilo z uporabo obrazca iz dela B Priloge III o hudem neželenem dogodku;
submit a complete report on serious adverse events to the competent authority on an annual basis using the format set out in Part C of Annex III.
z obrazcem iz dela C Priloge III pristojnim organom vsako leto predložijo popolno poročilo o hudih neželenih dogodkih.
Requirements for imported blood and blood components
Zahteve za uvoženo kri in komponente krvi
Member States shall ensure that for imports of blood and blood components from third countries blood establishments have a system of traceability in place equivalent to that provided for in Article 2(2) to (5).
Države članice zagotovijo, da imajo transfuzijske ustanove za uvoženo kri in komponente krvi iz tretjih držav sistem sledljivosti, enakovreden temu iz člena 2(2) do (5).
Member States shall ensure that for imports of blood and blood components from third countries blood establishments have a system of notification in place equivalent to that provided for in Articles 5 and 6.
Države članice zagotovijo, da imajo transfuzijske ustanove za uvoženo kri in komponente krvi iz tretjih držav sistem obveščanja, enakovreden temu iz členov 5 in 6.
Member States shall submit to the Commission an annual report, by 30 June of the following year, on the notification of serious adverse reactions and events received by the competent authority using the formats in Part D of Annex II and Part C of Annex III.
Države članice do 30. junija naslednjega leta predložijo Komisiji letno poročilo v obliki iz dela D Priloge II in dela C Priloge III o obveščanju o hudih neželenih reakcijah in dogodkih, ki jih prejmejo od pristojnega organa.
Communication of information between competent authorities
Posredovanje informacij med pristojnimi organi
Member States shall ensure that their competent authorities communicate to each other such information as is appropriate with regard to serious adverse reactions and events in order to guarantee that blood or blood components known or suspected to be defective are withdrawn from use and discarded.
Države članice zagotovijo, da njihovi pristojni organi posredujejo drug drugemu take informacije, kot je primerno zaradi hudih neželenih reakcij in dogodkov, da se zagotovi, da se kri in komponente krvi, za katere je znano ali se sumi, da niso ustrezne, umaknejo iz uporabe in odstranijo.
Without prejudice to Article 7 of Directive 2002/98/EC, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 August 2006 at the latest.
Ne glede na člen 7 Direktive 2002/98/ES države članice sprejmejo zakone in druge predpise za uskladitev s to direktivo najpozneje do 31. avgusta 2006.
This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
Ta direktiva začne veljati 20. dan po objavi v Uradnem listu Evropske unije.
OJ L 203, 21.7.1998, p. 14.
UL L 203, 21.7.1998, str. 14.
Record of data on traceability as provided for in Article 4
Zapisovanje podatkov o sledljivosti, kot predvideva člen 4
BY BLOOD ESTABLISHMENTS
S STRANI TRANSFUZIJSKIH USTANOV
Blood establishment identification
Identifikacija transfuzijske ustanove
Blood donor identification
Identifikacija krvodajalca
Blood unit identification
Identifikacija enote krvi
Individual blood component identification
Identifikacija posamezne komponente krvi
Date of collection (year/month/day)
Datum odvzema (leto, mesec, dan)
Facilities to which blood units or blood components are distributed, or subsequent disposition.
Ustanove, kamor so razdeljene ali kasneje odstranjene enote krvi ali komponente krvi.
BY FACILITIES
S STRANI USTANOV
Blood component supplier identification
Identifikacija dobavitelja komponente krvi
Issued blood component identification
Identifikacija izdane komponente krvi
Transfused recipient identification
Identifikacija prejemnika transfuzije
For blood units not transfused, confirmation of subsequent disposition
Potrdilo o odstranitvi za neporabljene enote krvi
Date of transfusion or disposition (year/month/day)
Datum transfuzije ali odstranitve (leto, mesec, dan)
Lot number of the component, if relevant.
Številka serije komponente, če je potrebno.
NOTIFICATION OF SERIOUS ADVERSE REACTIONS
OBVEŠČANJE O HUDIH NEŽELENIH REAKCIJAH
Rapid notification format for suspected serious adverse reactions
Obrazec za hitro obveščanje o sumu na hude neželene reakcije
Reporting establishment
Ustanova, ki poroča
Report identification
Identifikacija poročila
Reporting date (year/month/day)
Datum poročanja (leto, mesec, dan)
Date of transfusion (year/month/day)
Datum transfuzije (leto, mesec, dan)
Age and sex of recipient
Starost in spol prejemnika
Date of serious adverse reaction (year/month/day)
Datum hude neželene reakcije (leto, mesec, dan)
Serious adverse reaction is related to
Huda neželena reakcija je povezana:
Whole blood
S polno krvjo
Red blood cells
Z eritrociti
Platelets
S trombociti
Plasma
S plazmo
Other (specify)
Drugo (navedite)
Type of serious adverse reaction(s)
Vrsta hudih neželenih reakcij:
Immunological haemolysis due to ABO incompatibility
Imunska hemoliza zaradi neskladja v krvnih skupinah ABO
Immunological haemolysis due to other allo-antibody
Imunska hemoliza zaradi drugih aloprotiteles
Non-immunological haemolysis
Neimunska hemoliza
Transfusion-transmitted bacterial infection
S transfuzijo prenešena bakterijska okužba
Anaphylaxis/hypersensitivity
Anafilaksija/Preobčutljivost
Transfusion related acute lung injury
S transfuzijo povezana akutna okvara pljuč
Transfusion-transmitted viral infection (HBV)
S transfuzijo prenešena okužba s HBV
Transfusion-transmitted viral infection (HCV)
S transfuzijo prenešena okužba s HCV
Transfusion-transmitted viral infection (HIV-1/2)
S transfuzijo prenešena okužba s HIV-1/2
Transfusion-transmitted viral infection, Other (specify)
S transfuzijo prenešena virusna okužba, drugo (navedite)
Transfusion-transmitted parasitical infection (Malaria)
S transfuzijo prenešena okužba s parazitom malarije
Transfusion-transmitted parasitical infection, Other (specify)
S transfuzijo prenešena okužba s parazitom, drugo (navedite)
Post-transfusion purpura
Posttransfuzijska purpura
Graft versus host disease
Bolezen presadka proti gostitelju
Other serious reaction(s) (specify)
Druge hude reakcije (navedite).
Imputability level (NA, 0-3)
Stopnja povezanosti med transfuzijo in neželenimi reakcijami(NO, 0-3)
Serious adverse reactions — imputability levels
Hude neželene reakcije – stopnja povezanosti med transfuzijo in neželenimi reakcijami
Imputability levels to assess serious adverse reactions.
Ocenjevanje stopnje povezanosti med transfuzijo in hudimi neželenimi reakcijami
Imputability level
Stopnja
Explanation
Obrazložitev
Not assessable
Ni ocenljivo
When there is insufficient data for imputability assessment.
Kadar obstaja premalo podatkov za oceno povezanosti med transfuzijo in hudimi neželenimi reakcijami.
0Excluded
0Izključeno
When there is conclusive evidence beyond reasonable doubt for attributing the adverse reaction to alternative causes.
Kadar obstaja prepričljiv, nedvomen dokaz o tem, da je mogoče pripisati neželene reakcije drugim vzrokom.
Unlikely
Malo verjetno
When the evidence is clearly in favour of attributing the adverse reaction to causes other than the blood or blood components.
Kadar obstaja jasen dokaz o tem, da je neželeno reakcijo mogoče pripisati drugim vzrokom, ne krvi ali komponentam krvi.
Possible
Možno
When the evidence is indeterminate for attributing adverse reaction either to the blood or blood component or to alternative causes.
Kadar je dokaz o pripisovanju neželene reakcije krvi ali komponentam krvi ali drugim vzrokom nejasen.
Likely, Probable
Verjetno
When the evidence is clearly in favour of attributing the adverse reaction to the blood or blood component.
Kadar obstaja jasen dokaz o tem, da je neželeno reakcijo mogoče pripisati krvi ali komponentam krvi.
Certain
Nedvomno
When there is conclusive evidence beyond reasonable doubt for attributing the adverse reaction to the blood or blood component.
Kadar obstaja prepričljiv, nedvomen dokaz o tem, da je neželena reakcija posledica transfuzije krvi ali komponente krvi.
Confirmation format for serious adverse reactions
Obrazec za potrjevanje hudih neželenih reakcij
Confirmation date (year/month/day)
Datum potrditve (leto, mesec, dan)
Confirmation of serious adverse reaction (Yes/No)
Potrditev hude neželene reakcije (da/ne)
Change of type of serious adverse reaction (Yes/No)
Sprememba vrste hude neželene reakcije (da/ne)
If Yes, specify
Če je odgovor da, obrazložite
Clinical outcome (if known)
Klinični izid (če je znan):
Complete recovery
Popolna ozdravitev
Minor sequelae
Manjše posledice
Serious sequelae
Hude posledice
Death
Smrt.
Annual notification format for serious adverse reactions
Obrazec za letno obveščanje o hudih neželenih reakcijah
This Table refers to
Ta tabela se nanaša na:
[ ] Whole blood
[ ] polno kri
[ ] Red blood cells
[ ] eritrociti
[ ] Platelets
[ ] trombociti
[ ] Plasma
[ ] plazmo
[ ] Other
[ ] drugo
(use separate table for each component)
(za vsako komponento uporabite drugo tabelo).
Number of units issued (total number of units issued with a given number of blood components)
Število izdanih enot (skupno število izdanih enot z danim številom komponent krvi)
Number of recipients transfused (total number of recipients transfused with a given number of blood components) (if available)
Število prejemnikov transfuzije (skupno število prejemnikov s številom prejetih komponent krvi) (če obstajajo podatki)
Number of units transfused (the total number of blood components (units) transfused over the reporting period) (if available)
Število transfundiranih enot (skupno število komponent krvi (enot), uporabljenih za transfuzijo v obdobju poročanja) (če obstajajo podatki)
Total number reported
Skupno število poročil
Number of serious adverse reactions with imputability level 0 to 3 after confirmation (see Annex IIA)
Število hudih neželenih reakcij po potrditvi s stopnjo povezanosti od 0 do 3 (glej Prilogo IIA)
Number of deaths
Število smrtnih primerov
not assessable
Ni mogoče oceniti
Level
Stopnja
0Level
0Stopnja
Immunological Haemolysis
Imunska hemoliza
Due to ABO incompatibility
Zaradi neskladja v krvnih skupinah ABO
Due to other allo-antibody
Zaradi drugih aloprotiteles
Transfusion-transmitted viral Infection
S transfuzijo prenešena virusna okužba
Transfusion-transmitted parasitical infection
S transfuzijo prenešena okužba s parazitom
Other serious reactions (specify)
Druge hude reakcije (navedite)
NOTIFICATION OF SERIOUS ADVERSE EVENTS
OBVEŠČANJE O HUDIH NEŽELENIH DOGODKIH
Rapid Notification Format for Serious Adverse Events
Obrazec za hitro obveščanje o hudih neželenih dogodkih
Date of serious adverse event (year/month/day)
Datum hudega neželenega dogodka (leto, mesec, dan)
Serious adverse event, which may affect quality and safety of blood component due to a deviation in:
Hudi neželen dogodek, ki lahko vpliva na kakovost in varnost komponente krvi zaradi nepravilnosti pri:
Product defect
Napaka izdelka
Equipment failure
Napaka v opremi
Human error
Človeška napaka
(specify)
(navedite)
Whole blood collection
zbiranju polne krvi
Apheresis collection
aferezi
Testing of donations
testiranju dajalcev
Processing
predelavi
Storage
skladiščenju
Distribution
razdeljevanju
Materials
materialih
Others (specify)
drugo (navedite)
Confirmation Format for Serious Adverse Events
Obrazec za potrjevanje resnih neželenih dogodkov
Confirmation date(year/month/day)
Datum potrditve (leto, mesec, dan)
Date of serious adverse event(year/month/day)
Datum hudega neželenega dogodka (leto, mesec, dan)
Root cause analysis (details)
Analiza izvornega vzroka (podrobnosti)
Corrective measures taken (details)
Sprejeti korektivni ukrepi (podrobnosti)
Annual Notification Format for Serious Adverse Events
Obrazec za letno obveščanje o resnih neželenih dogodkih
1 January-31 December (year)
od 1. januarja do 31. decembra (leto)
Total number of blood and blood components processed:
Skupno število enot predelane krvi in komponent krvi:
Serious adverse event, affecting quality and safety of blood component due to a deviation in:
Hud neželen dogodek, ki je vplival na kakovost in varnost komponente krvi zaradi nepravilnosti pri:
Total number
Skupno število
Commission Directive 2005/62/EC
Direktiva Komisije 2005/62/ES
implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments
o izvajanju Direktive Evropskega parlamenta in Sveta 2002/98/ES glede standardov in specifikacij Skupnosti v zvezi s sistemom kakovosti za transfuzijske ustanove
Having regard to Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC [1], and in particular point (h) of the second paragraph of Article 29 thereof,
ob upoštevanju Direktive Evropskega parlamenta in Sveta 2002/98/ES z dne 27. januarja 2003 o določitvi standardov kakovosti in varnosti za zbiranje, preskušanje, predelavo, shranjevanje in razdeljevanje človeške krvi in komponent krvi ter o spremembi Direktive 2001/83/ES [1] in zlasti točke (h) drugega odstavka člena 29 Direktive,
Directive 2002/98/EC lays down standards of quality and safety for the collection and testing of human blood and blood components, whatever their intended purpose, and for their processing, storage and distribution when intended for transfusion so as to ensure a high level of human health protection.
Direktiva 2002/98/ES določa standarde kakovosti in varnosti za zbiranje ter preskušanje človeške krvi in komponent krvi, ne glede na namen njihove uporabe, in za njihovo predelavo, shranjevanje in razdeljevanje za potrebe transfuzije, da se zagotovi visoka raven varovanja zdravja ljudi.
In order to prevent the transmission of diseases by blood and blood components and to ensure an equivalent level of quality and safety, Directive 2002/98/EC calls for the establishment of specific technical requirements including Community standards and specifications with regard to a quality system for blood establishments.
Da se prepreči prenos bolezni s krvjo in komponentami krvi in da se zagotovi enaka raven kakovosti in varnosti, Direktiva 2002/98/ES predvideva uvedbo posebnih tehničnih zahtev, vključno s standardi Skupnosti in specifikacijami, ki zadevajo sistem kakovosti za transfuzijske ustanove.
A quality system for blood establishments should embrace the principles of quality management, quality assurance, and continuous quality improvement, and should include personnel, premises and equipment, documentation, collection, testing and processing, storage and distribution, contract management, non-conformance and self-inspection, quality control, blood component recall, and external and internal auditing.
Sistem kakovosti za transfuzijske ustanove se mora ravnati po načelih vodenja, zagotavljanja ter nenehnega izboljševanja kakovosti, vanj pa morajo biti vključeni osebje, prostori in oprema, dokumentacija, zbiranje, preskušanje in predelava, shranjevanje in razdeljevanje, pogodbeno delo, nadzor neskladnosti in notranji nadzor, nadzor kakovosti, odpoklic komponent krvi ter zunanje in notranje preverjanje.
This Directive lays down those technical requirements, which take account of Council Recommendation 98/463/EC of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the European Community [2], Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [3], Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use [4], Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components [5], certain recommendations of the Council of Europe, the monographs of the European Pharmacopoeia, particularly in respect of blood or blood components as a starting material for the manufacture of proprietary medicinal products, recommendations of the World Health Organisation, as well as international experience in this field.
Ta direktiva določa navedene tehnične zahteve, ki upoštevajo Priporočilo Sveta 98/463/ES z dne 29. junija 1998 o primernosti dajalcev krvi in plazme ter testiranju zbrane krvi v Evropski skupnosti [2], Direktivo Evropskega parlamenta in Sveta 2001/83/ES z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [3], Direktivo Komisije 2003/94/ES z dne 8. oktobra 2003 o določitvi načel in smernic dobre proizvodne prakse v zvezi z zdravili za uporabo v humani medicini in zdravili za uporabo v humani medicini v preskušanju [4], Direktivo Komisije 2004/33/ES z dne 22. marca 2004 o izvajanju Direktive Evropskega parlamenta in Sveta 2002/98/ES glede tehničnih zahtev za kri in komponente krvi [5], nekatera priporočila Sveta Evrope, monografije v Evropski farmakopeji, zlasti glede krvi ali komponent krvi kot vhodnih snovi za proizvodnjo lastniških zdravil, pa tudi priporočila Svetovne zdravstvene organizacije (WHO) in mednarodne izkušnje na tem področju.
In order to ensure the highest quality and safety for blood and blood components, guidance on good practice should be developed to support the quality system requirements for blood establishments taking fully into account the detailed guidelines referred to in Article 47 of Directive 2001/83/EC so as to ensure that the standards required for medicinal products are maintained.
Da bi zagotovili najvišjo kakovost ter varnost krvi in komponent krvi, je treba izdelati smernice dobre prakse, ki bodo v podporo sistemu kakovosti za transfuzijske ustanove, ob polnem upoštevanju podrobnih smernic iz člena 47 Direktive 2001/83/ES, in bo zagotovljeno ohranjanje standardov, ki se zahtevajo za zdravila.
Blood and blood components imported from third countries, including those used as starting material or raw material for the manufacture of medicinal products derived from human blood and human plasma intended for distribution in the Community, should meet equivalent Community standards and specifications relating to a quality system for blood establishments as set out in this Directive.
Kri in komponente krvi, uvožene iz tretjih držav, vključno s tistimi, ki se uporabljajo kot vhodna snov ali surovina za izdelavo zdravil, pripravljenih iz človeške krvi in človeške plazme, namenjene za razdeljevanje v Skupnosti, morajo izpolnjevati standarde, ki so enakovredni standardom Skupnosti, in specifikacije glede sistema kakovosti za transfuzijske ustanove, kakor ga določa ta direktiva.