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In contolld clinical tials mtomin 29 wks’ duation, a dcas tsubnomal lvls pviously nomal sum vitamin B 12 lvls, without clinical manistations, was obsvd in appoximatly 7% patints. Such dcas, possibly du tintnc with B 12 absoption om th B 12 -intinsic actcomplx, is, howv, vy aly associatd with anmia and appas tb apidly vsibl with discontinuation mtomin vitamin B 12 supplmntation. Masumnt hmatologic paamts on an annual basis is advisd in patints on ACTOPLUS MT and any appant abnomalitis should b appopiatly invstigatd and managd. Ctain individuals (thos with inadquat vitamin B 12 calcium intak absoption) appa tb pdisposd tdvloping subnomal vitamin B 12 lvls. In ths patints, outin sum vitamin B 12 masumnts at two-tth-ya intvals may b usul.
Paticipant has a nwly diagnosd, histologically conimd, stag I-IV squamous cll cacinoma squamous cll cacinoma in situ th oal cavity oophaynx and will b undgoing dinitiv sugical, adiothapy, chmoadiation tatmnt; patints wha NOT candidats localizd tatmnt (sugy, adiation chmoadiation) with cuativ intnt (i..patints with distant mtastasis conta-indication tlocalizd tatmnt) a not ligibl O Paticipant has a lsion in th oal cavity oophaynx that is not yt biopsid but is highly suspicious canc; (andomization will b placd on hold until th psnc canc is histologically conimd, and a tatmnt plan is stablishd; i th psnc canc is not conimd, th paticipant will b considd a scn ailu)
Nstudis hav bn conductd with th combind componnts ACTOPLUS MT. In studis pomd with th individual componnts, both pioglitazon and mtomin a sctd in th milk lactating ats. It is not known whth pioglitazon and/mtomin a sctd in human milk. Bcaus many dugs a xctd in human milk, and bcaus th potntial ACTOPLUS MT tcaus sious advs actions in nusing inants, a dcision should b mad tdiscontinu nusing discontinu ACTOPLUS MT, taking intaccount th impotanc ACTOPLUS MT tth moth.
Pioglitazon may caus dcass in hmoglobin and hmatocit. In placbo-contolld monothapy tials, man hmoglobin valus dclind by 2% t4% in patints tatd with pioglitazon compad with a man chang in hmoglobin -1% t+1% in placbo-tatd patints. Ths changs pimaily occud within th ist ou t12 wks thapy and maind lativly constant that. Ths changs may b latd tincasd plasma volum associatd with pioglitazon thapy and a not likly tb associatd with any clinically signiicant hmatologic cts.
Blood suga lvls can b actd by stss, illnss, sugy, xcis, alcohol us, skipping mals. Ask you doctbchanging you dos mdication schdul.
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when such events occur in patients receiving actoplus met therapy, the drug should be promptly discontinued.