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Διαλύτης ......................................................................................................................................qs 1 dose
diluent.........................................................................................................................................qs 1 dose

56x1 δισκίο (unit dose)
56x1 tablet (unit dose)

49 x 1 δισκία (unit dose)
49 x 1 tablets

repeat- dose (90 days) toxicity testing
repeat-dose (90 days) toxicity testing

flexirox 20 mg, poudre Αναβράζονe en sachet- dose
flexirox 20 mg, poudre effervescente en sachet-dose

3, 6 log10 pfu Έκδοχα ……………………………………………………………………............ qs 1 dose Διαλύτης:
3.6 log10 pfu excipient........................................................................................................................... qs 1 dose diluent:

perforated unit dose blister (pvc/ pe/ pvdc/ alu)
blister (pvc/ pe/ pvdc/ alu) blister (pvc/ pe/ pvdc/ alu) blister (pvc/ pe/ pvdc/ alu) blister (pvc/ pe/ pvdc/ alu) blister (pvc/ pe/ pvdc/ alu) perforated unit dose blister (pvc/ pe/ pvdc/ alu)

single- dose fluoroquinolone therapy of acute uncomplicated urinary tract infection in women:
single-dose fluoroquinolone therapy of acute uncomplicated urinary tract infection in women:

position paper on the non- clinical safety studies to support clinical trials with a single low dose of a compound
note for guidance on photosafety testing

concept paper on the development of a cpmp position paper on the non- clinical safety studies to support low dose clinical screening studies in humans
concept paper on the development of a cpmp position paper on the non-clinical safety studies to support low dose clinical screening studies in humans

Μεγέθη συσκευασίας των 14, 28, 56, 168 δισκίων ελεγχόμενης αποδέσμευσης και 32 x 1 δισκία ελεγχόμενης αποδέσμευσης σε διάτρητη unit dose κυψέλη.
pack sizes of 14, 28, 56, 168 modified-release tablets and 32 x 1 modified-release tablets in a perforated unit dose blister.

Ο παρακάτω πίνακας παρουσιάζει τη δοσιμετρία όπως υπολογίστηκε με χρήση του λογισμικού olinda (organ level internal dose assessment).
the table below shows the dosimetry as calculated using the olinda (organ level internal dose assessment) software.

Οι δοσιμετρικοί υπολογισμοί βασίσθηκαν σε κλινικές μελέτες βιοκατανομής με χρήση μεθόδων που αναπτύχθηκαν για τους υπολογισμούς της δόσης ακτινοβολίας από την Επιτροπή mird (medical internal radiation dose) της Εταιρείας Πυρηνικής Ιατρικής.
the dosimetry estimates were based on clinical biodistribution studies using methods developed for radiation dose calculations by the medical internal radiation dose (mird) committee of the society of nuclear medicine.