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Pgnancy: Limitd data with mtomin/pioglitazon pioglitazon in pgnant womn a not suicint tdtmin a dug-associatd isk majbith dcts miscaiag; pooly contolld diabts in pgnancy incass matnal isk diabtic ktoacidosis, p-clampsia, spontanous abotions, ptm dlivy, still bith and dlivy complications; pooly contolld diabts incass tal isk majbith dcts, still bith, and macosomia latd mobidity.

Thiazolidindions, including pioglitazon and osiglitazon, caus xacbat congstiv hat ailu in som patints Monitcaully at initiation dos incass signs and symptoms hat ailu (including xcssiv, apid wight gain; dyspna; and/dma); i ths signs symptoms dvlop, manag hat ailu accoding cunt standads ca; consid discontinuing ducing dos Not commndd in patints with symptomatic hat ailu; initiation ths dugs in patints with stablishd NYHA class III IV hat ailu is containdicatd.

V. Compa and colat p- and post-ACTOplus mt X tatmnt human ibonuclic acid (NA)-squncing (sq) gn analysis on total NA sampls om oal cavity/oophayngal adjacnt visually nomal appaing tissu and tumtissu p-and post-study tatmnt.

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Bcaus pioglitazon nhancs th cts ciculating insulin (by dcasing insulin sistanc), it dos not low blood glucos in animal modls that lack ndognous insulin.

Tabl 12: Wight Changs (kg) om Baslin Duing Doubl-Blind Clinical Tial with ACTOPLUS MT in Patints with Inadquat Glycmic Contol on Dit and xcis.

X: Dnot us in pgnancy. isks involvd outwigh potntial bnits. Sa altnativs xist.

Choosing tpaticipat in a study is an impotant psonal dcision. Talk with you doctand amily mmbs inds about dciding tjoin a study. Tlan mabout this study, you you doctmay contact th study sach sta using th contacts povidd blow. gnal inomation, Lan About Clinical Studis.

ACTOPLUS MT should b usd with caution in patints with dma. Bcaus thiazolidindions, including pioglitazon, can caus luid tntion, which can xacbat lad tcongstiv hat ailu, ACTOPLUS MT should b usd with caution in patints at isk congstiv hat ailu. Patints tatd with ACTOPLUS MT should b monitod signs and symptoms congstiv hat ailu [s BOXD WANING , Congstiv Hat ailu , and PATINT INOMATION ].

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Macula dma has bn potd in postmakting xpinc in diabtic patints whw taking pioglitazon anoth thiazolidindion. Som patints psntd with blud vision dcasd visual acuity, but oths w diagnosd on outin ophthalmologic xamination.

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Bladd canc Pioglitazon may b linkd tan incasd isk bladd canc Dnot pscib patints with activ bladd canc Consid bnit:isk atibpscibing in patints with a histoy bladd canc Instuct patints tcontact thi physician i signs bladd canc obsvd at initiating thapy (g, blood d colod uin, nw wosning uinay ugncy, pain on uination) Postat canc 7/22/2015: Compad with nonus, pioglitazon us was associatd with incasd isk postat canc (453.3 vs. 449.3 p 100,000 pson-yas) [JAMA 2015 July 21;314(3):265-277] Pancatic canc 7/22/2015: Compad with nonus, pioglitazon us was associatd with incasd isk pancatic canc (81.1 vs. 48.4 p 100,000 pson-yas) [JAMA 2015 July 21;314(3):265-277]

Th onst lactic acidosis otn is subtl, and accompanid only by nonspciic symptoms such as malais, myalgias, spiatoy distss, incasing somnolnc, and nonspciic abdominal distss. Th may b associatd hypothmia, hypotnsion, and sistant badyahythmias with mmakd acidosis. Patints should b ducatd tpomptly pot ths symptoms should thy occu. I psnt, ACTOPLUS MT should b withdawn until lactic acidosis is uld out. Sum lctolyts, ktons, blood glucos, blood pH, lactat lvls, and blood mtomin lvls may b usul. Onc a patint is stabilizd on any dos lvl mtomin, gastointstinal symptoms, which a common duing initiation thapy, a unlikly tcu. Lat occunc gastointstinal symptoms could b du tlactic acidosis oth sious disas.

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