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irregularitajiet irraportati mill-istati membri
irregularities reported by member states

Ġew irraportati l- effetti avversi li ġejjin:
the following adverse reactions have been reported:

Ġew irraportati każijiet iżolati ta 'dawn li ġejjin:
single cases of the following have been reported:

b’mod ġenerali, ma ġewx irraportati problemi speċifiċi ta’ koordinazzjoni.
in general, no specific coordination problems have been reported.

perforazzjoni gastro- intestinali ġew irraportati f’pazjenti ikkurati minn tracolimus.
gastrointestinal perforation has been reported in patients treated with tacrolimus.

infezzjonijiet tat-tuberkulożi ġew irraportati f’pażjenti kkurati b’zinbryta.
tuberculosis infections have been reported in patients treated with zinbryta.

l- aktar reazzjonijiet komuni li ġew irraportati huma mniżżlin f’ sezzjoni 4. 8.
the most commonly reported reactions are listed in section 4.8.

każijiet mhux komuni ta’ edima ġew irraportati f’pazjenti kkurati b’pemetrexed.
uncommon cases of oedema have been reported in patients treated with pemetrexed.

f’ ċerti każijiet, reazzjonijiet serji ħafna ta ’ sensittivita` eċċessiva ġew irraportati.
in some cases very serious hypersensitivity reactions have been reported.

dawn il- każi ġew irraportati b’ esperjenza wara li l- mediċina tpoġġiet fis- suq:
the following events have been reported in post-marketing experience:

sensittività eċċessiva: ġew irraportati reazzjonijiet ta ’ sensittività eċċessiva, li jinkludu edema angionewtrotika u reazzjoni anafilattika.
22 hypersensitivity: hypersensitivity reactions, including angioneurotic oedema and anaphylactic reaction have been reported.

kif ukoll, polz iħabbat ħafna u abnormalitajiet fil- valv tal- qalb ġew irraportati bi trattament ta ’ increlex.
also, a racing pulse and heart valve abnormalities have been reported with increlex treatment.

l- izjed effetti mhux mixtieqa li gew irraportati kienu sturdament, nagħas, uġigħ ta ’ ras u sturdament meta tqum minn mindud.
the most frequently reported adverse reactions were dizziness, somnolence, headache and postural dizziness.

- xi ftit każijiet ta 'leżjonijiet fuq il- ġilda fil- minkbejn, bħal gundalli iebsin żgħar, ġew irraportati
- a few cases of skin lesions on elbows like little hard lumps have been reported in children

iċ- ċrieki ta ’ dawl kienu fil- biċċa l - kbira irraportati li huma ta ’ intensita` moderata.
phosphenes were generally reported to be of mild to moderate intensity.

in-numri tal-kolonji revertanti kull pjanċa huma irraportati kemm għas-serje tal-kontroll u wkoll ta’ dawk ittrattati.
the number of revertant colonies per plate are reported for both control and treated series.

il-biċċa l-kbira tal-każijiet kienu minn ħfief sa moderati; madankollu, każijiet ta’ grad sever ġew irraportati.
most events were mild to moderate; however, severe cases have been reported.

it-tip u l-mod ta’ tumuri malinni li ġew irraportati waqt il-perijodu ta’ open-label tal-provi kienu simili għal dawk irrapportati waqt l-esperjenza double-blind.
the type and pattern of malignancies reported during the open-label period of the trials were similar to those reported for the double-blind experience.