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mono fuel
fjuwil wieħed
Last Update: 2014-11-21
Usage Frequency: 2
Quality:
mono study
l-istudju mono
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
mono- therapy
investigazzjoniji et
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
the chmp considered that the safety data submitted indicates that the local and systemic aes observed during clinical studies were as expected in terms of types and rates for a polysaccharide- protein conjugate vaccine and showed similar reactogenicity to other mono-component menc and hib vaccines in various clinical studies.
is- chmp ikkunsidra li t- tagħrif ta ’ sigurtà sottomess jindika li l- każijiet avversi lokali u sistemiċi osservati waqt studji kliniċi kienu kif mistennija f’ tipi u rati għall- vaċċin ikkonjugat ta ’ polisakkarajd - proteina u urew reazzjoniġeniċità għal vaċċini menc u hib ta ’ komponent wieħed f’ diversi studji kliniċi.
the safety profile of the combined use of saxagliptin plus dapagliflozin in these trials for up to 52 weeks was comparable to the safety profiles for the mono-components.
il- profil tas-sigurtà tal-użu kombinat ta' saxagliptin kif ukoll dapagliflozin f'dawn il-provi sa 52 ġimgħa kien komparabbli mal-profili tas-sigurtà tal-mono-komponenti.
a adverse reactions reported in ≥ 2 % of subjects treated with the combined use of saxagliptin + dapagliflozin in the pooled safety analysis, or if reported in < 2 % in the pooled safety analysis, they were based on the individual mono-components data.
a reazzjonijiet avversi rrapportati f’≥ 2 % tal-individwi kkurati bl-użu kombinat ta’ saxagliptin + dapagliflozin fl-analiżi tas-sigurtà miġbura, jew jekk rapportati f’< 2 % fl-analiżi tas-sigurtà miġbura, kienu bbażati fuq id-dejta dwar il-mono-komponenti individwali.