Roundwhale R-C1 - 2.2.4 Adverse Reactions


QBJOQBUJFOUT
 4JODFUIFFFDUTPGTUJNVMBUJPOPGUIFCSBJOBSFVO
LOPXOTUJNVMBUJPOTIPVMEOPUCFBQQMJFEBDSPTTZPVS
IFBEBOEFMFDUSPEFTTIPVMEOPUCFQMBDFEPOPQQPTJUF
TJEFTPGZPVSIFBE
 5IFTBGFUZPGFMFDUSJDBMTUJNVMBUJPOEVSJOHQSFHOBODZ
IBTOPUCFFOFTUBCMJTIFE
 :PVNBZFYQFSJFODFTLJOJSSJUBUJPOPSIZQFSTFOTJUJWJUZ
EVFUPUIFFMFDUSJDBMTUJNVMBUJPOPSFMFDUSJDBMDPOEVD
UJWFNFEJVNTJMJDBHFM
 *GZPVIBWFTVTQFDUFEPSEJBHOPTFEIFBSUEJTFBTFPS
FQJMFQTZZPVTIPVMEGPMMPXQSFDBVUJPOTSFDPNNFOEFE
CZZPVSQIZTJDJBO
 $BVUJPOJGZPVIBWFBUFOEFODZUPCMFFEJOUFSOBMMZFH
GPMMPXJOHBOJOKVSZPGGSBDUVSF
 $POTVMUXJUIZPVSQIZTJDJBOQSJPSUPVTFUIFEFWJDF
BGUFSBSFDFOUTVSHJDBMQSPDFEVSFCFDBVTFTUJNVMBUJPO
NBZEJTSVQUUIFIFBMJOHQSPDFTT
 $BVUJPOJGTUJNVMBUJPOJTJOUFOEFEUPCFBQQMJFEPWFS
UIFNFOTUSVBUJPOPSQSFHOBOUVUFSVT
 'PSTJOHMFQBUJFOUVTFPOMZ
 5IJTTUJNVMBUPSTIPVMEOPUCFVTFECZQBUJFOUTXIPJT
OPODPNQMJBOUBOEFNPUJPOBMMZEJTUVSCFEJODMVEJOH
XIPNXJUIEFNFOUJBPSMPX*2
 5IFJOTUSVDUJPOPGVTFJTMJTUFEBOETIPVMECFPCFZFE
BOZJNQSPQFSVTFNBZCFEBOHFSPVT
 3BSFDBTFTPGTLJOJSSJUBUJPONBZPDDVSBUUIFTJUFPGUIF
FMFDUSPEFQMBDFNFOUGPMMPXJOHMPOHUFSNBQQMJDBUJPO
 %POPUVTFUIJTEFWJDFJOUIFQSFTFODFPGPUIFSFRVJQ
NFOUXIJDITFOETFMFDUSJDBMQVMTFTUPZPVSCPEZ
 %POPUVTFTIBSQPCKFDUTTVDIBTBQFODJMPSCBMMQPJOU
UJQUPPQFSBUFUIFCVUUPOTPOUIFDPOUSPMQBOFM