4 Skond rapport dwar studji dwar il- Busilvex kien hemm każ ta ’ sindrom ta 'periklu respiratorju akut u falliment respiratorju assoċjat ma ’ fibrożi pulmonari interstizjali, dan il- pazjent miet, għalkemm, ma kienet identifikata l- ebda etjoloġija ċara. | 4 Occurrence of acute respiratory distress syndrome with subsequent respiratory failure associated with interstitial pulmonary fibrosis was reported in Busilvex studies in one patient who died, although, no clear aetiology was identified. |
Anatoli Marchenko (1938–1986), wieħed mid-dissidenti l-aktar magħrufa tal-eks-Unjoni Sovjetika, miet fil-ħabs ta’Christopol f’Diċembru 1986 riżultat ta’ strajk tal-ġuħ wara 20 sena fil-ħabs. | Anatoli Marchenko (1938–1986), one of the former Soviet Union’s best-known dissidents, died in Chistopol prison in December 1986 as the result of a hunger strike after more than 20years in prison. |
Biss, il- mewt ta ’ 4 pazjenti kienet meqjusa mill - investigatur ta ’ l- istudju li hi marbuta mat- trattament b ’ clofarabine: pazjent esperjenza sindrom tat - tnixxija vaskulari akuta li kienet marbuta ma 'clofarabine li wasslet għall- arrest kardijaku; pazjent miet minn problema respiratorja u ħsara epatoċellulari; pazjent minn xokk setptiku u falliment multi - organiku: pazjent minn falliment multi- organiku. | However, the deaths of 4 patients were considered by the study investigator to be related to treatment with clofarabine: one patient experienced clofarabine-related acute vascular leak syndrome that contributed to cardiac arrest; one patient died from respiratory distress and hepatocellular damage; one patient from septic shock and multi-organ failure; and one patient from multi-organ failure. |
Disgħa u tletin każ f’ 22/ 132 pazjenti kienu meqjusa li kienu marbuta ma ’ clofarabine li minnhom infezzjoni ta ’ l- impjant (każ wieħed), sepsis (każ wieħed), xokk septiku (2 każi; pazjent wieħed miet (ara hawn fuq)) kienu meqjusa serji. | Thirty nine events in 22/ 132 patients were considered to be related to clofarabine of which implant infection (1 event), sepsis (1 event) and septic shock (2 events; 1 patient died (see above)) were considered to be serious. |
Erbatax- il każ f’ 10/ 132 pazjent kienu meqjusa bħala marbuta ma ’ clofarabine li minnhom kien hemm koleċistite akuta (1 każ), kolelitjasis (1 każ), ħsara epatoċelluri (1 każ; il- pazjent miet (ara hawn fuq)) u iperbilirubinemja (2 każi; pazjent ma kompliex it- terapija (ara hawn fuq) kienu meqjusa serji. | Fourteen events in 10/ 132 patients were considered to be related to clofarabine of which acute cholecystitis (1 event), cholelithiasis (1 event), hepatocellular damage (1 event; patient died (see above)) and hyperbilirubinaemia (2 events; patients discontinued therapy (see above)) were considered to be serious. |
(ċ) ikunu ġew maqtula qabel ma jkun għadda dan il-perjodu għal raġunijiet ta’ saħħa jew mietu minħabba mard jew inċident. | have been slaughtered for health reasons or have died as a result of sickness or accident before that period has elapsed. |
(ċ) inqatlu għal raġunijiet ta’ saħħa jew mietu b’riżultat ta’ mard jew inċident qabel ma jkun skada dan il-perjodu; | have been slaughtered for health reasons or have died as a result of sickness or accident before that period has elapsed. |
Fejn il-każ tat-TSE kkonfermat f’azjenda jkun każ ta’ scrapie atipika, l-azjenda għandha tiġi soġġetta għall-protokoll intensifikat ta’ monitoraġġ tat-TSE li jidher hawn taħt għal perjodu ta’ sentejn mid-data tal-iskoperta tal-aħħar każ ta’ scrapie atipika: l-annimali ovini u kaprini kollha li għandhom iktar minn 18-il xahar u li nqatlu għall-konsum mill-bniedem u l-annimali ovini u kaprini kollha li għandhom iktar minn 18-il xahar li mietu jew li nqatlu fl-azjenda għandhom jiġu ttestjati għall-preżenza tat-TSE skont il-metodi tal-laboratorju u l-protokolli stabbiliti fl-Anness X, Kapitolu C, Parti 3, punt 3.2. | Where the TSE case confirmed on a holding is an atypical scrapie case, the holding shall be subject to the following intensified TSE monitoring protocol for a period of two years from the date of the detection of the last atypical scrapie case: all ovine and caprine animals which are over the age of 18 months and slaughtered for human consumption and all ovine and caprine animals over the age of 18 months which have died or been killed on the holding shall be tested for the presence of TSE in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2. |
Fejn l-annimali jkunu mietu matul it-trasport b’riżultat ta’ forza maġġuri wara li ħallew it-territorju doganali tal-Komunità: | Where the animals have died during transport as a result of force majeure after leaving the customs territory of the Community: |
Għall-annimali li mietu, il-kawża tal-mewt għandha, meta magħrufa, tiġi nnotata; u | For animals that have died, the cause of death shall, when known, be noted; and |