KCD9B9K =;5e "WQ`MWN_^Q\ZW ^M\^\M^Q# >YTMWM^UZY 5Q\Z]ZW

Átírás

1 KCD9B9K =;5e "WQ`MWN_^Q\ZW ^M\^\M^Q# >YTMWM^UZY 5Q\Z]ZW ;Z\ C\MW >YTMWM^UZY CYWb PRESCRIBING INFORMATION DESCRIPTION K[X TVg\iX Vb`cbaXag by OFG<E<O?=7 #_XiT_UhgXeb_ 7Xebfb_ \f _XiT_UhgXeb_ gtegetgx& g[x #I$'XaTag\b`Xe by T_UhgXeb_( CXiT_UhgXeb_ gtegetgx \f T ex_tg\ix_l fx_xvg\ix UXgT, 'TWeXaXeZ\V exvxcgbe TZba\fg #fxx 7@>B>75@ D=5EA57C@C<L$( CXiT_UhgXeb_ gtegetgx [Tf g[x V[X`\VT_ at`x #I$'" + 'RR#+&+'W\`Xg[l_Xg[l_$T`\abS`Xg[l_S'.'[lWebkl'+&-'UXamXaXW\`Xg[Tab_ C'gTegeTgX #,4+ ft_g$& TaW \g [Tf g[x Yb bj\az V[X`\VT_ fgehvghex4 OH H N HO OH HO HOOC COOH OH 2 K[X `b_xvh_te jx\z[g by _XiT_UhgXeb_ gtegetgx \f 0,2(1+& TaW \gf X`c\e\VT_ Ybe`h_T \f #9 +-?,+ EF - $, u 9.? 0 F 0 \f T j[\gx gb _\Z[g'lX bj fb_\w& YeXX_l fb_hu_x \a jtgxe TaW ixel f_\z[g_l fb_hu_x \a Xg[Tab_( CXiT_UhgXeb_ gtegetgx \f g[x ZXaXe\V at`x Ybe #I$'T_UhgXeb_ gtegetgx \a g[x La\gXW JgTgXf( 7Xebfb_ \f T cexffhe\mxw `XgXeXW'WbfX TXebfb_ \a[t_xe #D;@$& j[\v[ cebwhvxf Ta TXebfb_ Ybe bet_ VbagT\af T fhfcxaf\ba by `\Veba\mXW _XiT_UhgXeb_ gtegetgx& cebcx Tag?=7'+-.T #+&+&+&,'gxgety_hbebxg[tax$& ;X[lWeTgXW 7_Vb[b_ LJG& TaW F_X\V 7V\W E=( K[X \a[t_xe f[bh_w UX ce\`xw Ul ex_xtf\az. fcetlf \agb g[x T\e& TjTl Yeb` g[x YTVX& UXYbeX hf\az \g Ybe g[x Y\efg g\`x TaW j[xa g[x \a[t_xe [Tf abg UXXa hfxw Ybe `bex g[ta - WTlf( 7YgXe ce\`\az j\g[. TVghTg\baf& XTV[ TVghTg\ba WX_\iXef /3 `VZ by _XiT_UhgXeb_ gtegetgx #Xdh\iT_Xag gb./ `VZ by _XiT_UhgXeb_ YeXX UTfX$ Yeb` g[x TVghTgbe #be `bhg[c\xvx$( <TV[ +/ Z VTa\fgXe cebi\wxf,** TVghTg\baf #be \a[t_tg\baf$ TaW XTV[ 2(. Z VTa\fgXe cebi\wxf 2* TVghTg\baf #be \a[t_tg\baf$( K[\f cebwhvg WbXf abg VbagT\a V[_bebY_hbebVTeUbaf #9=9f$( CLINICAL PHARMACOLOGY AQOTMYU]X ZR 5O^UZY2 7Vg\iTg\ba by UXgT, 'TWeXaXeZ\V exvxcgbef ba T\ejTl f`bbg[ `hfv_x _XTWf gb g[x TVg\iTg\ba by TWXal_TgX VlV_TfX TaW gb Ta \avextfx \a g[x \agetvx h_te VbaVXageTg\ba by VlV_\V'-"& /"'TWXabf\aX `babc[bfc[tgx #VlV_\V 7DG$( K[X \avextfx \a VlV_\V 7DG \f TffbV\TgXW j\g[ g[x TVg\iTg\ba by cebgx\a ^\atfx 7& j[\v[ \a ghea& \a[\u\gf )

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3 Pharmacokinetics 7 cbch_tg\ba c[te`tvb^\axg\v #GGB$ `bwx_ jtf WXiX_bcXW hf\az c_tf`t VbaVXageTg\baf by #I$'T_UhgXeb_ bugt\axw Yeb` 0-, Tfg[`Tg\V ctg\xagf TZXW. gb 2+ lxtef \a g[exx _TeZX ge\t_f( K[X GGB `bwx_'wxe\ixw c[te`tvb^\axg\v ctet`xgxef Ybe #I$'T_UhgXeb_ \a cxw\tge\v TaW TWb_XfVXag)TWh_g ctg\xagf exvx\i\az T 3* `VZ WbfX by OFG<E<O?=7 #_XiT_UhgXeb_ 7Xebfb_ be T +2* `VZ WbfX by etvx`\v T_UhgXeb_ Ul?=7 `XgXeXW'WbfX \a[t_xe TeX cexfxagxw \a KTU_X +( K[XfX c[te`tvb^\axg\v WTgT \aw\vtgx g[tg `XTa XkcbfheX gb #I$'T_UhgXeb_ jtf +-! gb +0! _Xff \a TWh_g TaW -*! gb -,! _Xff \a cxw\tge\v ctg\xagf Z\iXa 7Xebfb_ Tf Vb`cTeXW gb g[bfx Z\iXa T Vb`cTeTU_X WbfX by etvx`\v T_UhgXeb_( N[Xa Vb`cTeXW gb TWh_g ctg\xagf& cxw\tge\v ctg\xagf Z\iXa 3* `VZ by _XiT_UhgXeb_ [TiX T +1! _bjxe `XTa XkcbfheX gb #I$'T_UhgXeb_( GMNWQ )2 AQMY AZPQW&D\QPUO^QP "E#&5WN_^Q\ZW DTM\XMOZVUYQ^UO DM\MXQ^Q\] F^_Pb DZ[_WM^UZY 7Wb_XfVXag)7Wh_g GTg\Xagf #"+, lxtef$ GXW\Tge\V GTg\Xagf #.'++ lxtef$ DM\MXQ^Q\ KCD9B9K =;5 >YTMWM^UZY 5Q\Z]ZW G\QM^XQY^ EMOQXUO 5WN_^Q\ZW =;5 A8> 9`Tk #az)`c$ *(+33 *(,-2 g`tk #[e$ *(/. *(/- 7L9 #*'0$ #azu[e)`c$ *(03/ *(132 9`Tk #az)`c$ *(+0- *(,-2 g`tk #[e$ *(10 *(12 7L9 #*'0$ #azu[e)`c$ *(/13 *(2,2 Metabolism and TiT\_TU_X \a g[x chu_\f[xw _\gxetghex fhzzxfgf g[tg g[x ce\`tel Xaml`X exfcbaf\u_x Ybe g[x `XgTUb_\f` by T_UhgXeb_ XaTag\b`Xef \a [h`taf \f JLCK+7- #fh_ybgetafyxetfx$( N[Xa etvx`\v T_UhgXeb_ jtf TW`\a\fgXeXW X\g[Xe \agetixabhf_l be i\t \a[t_tg\ba TYgXe bet_ V[TeVbT_ TW`\a\fgeTg\ba& g[xex jtf T -' gb.'yb_w W\YYXeXaVX \a g[x TeXT hawxe g[x VbaVXageTg\ba'g\`X VheiXf UXgjXXa g[x #I$' TaW #J$'T_UhgXeb_ XaTag\b`Xef& j\g[ #J$'T_UhgXeb_ VbaVXageTg\baf UX\aZ Vbaf\fgXag_l [\Z[Xe(?bjXiXe& j\g[bhg V[TeVbT_ cexgextg`xag& TYgXe X\g[Xe bet_ be \a[t_tg\ba TW`\a\fgeTg\ba g[x W\YYXeXaVXf jxex 2' gb,.' Yb_W& fhzzxfg\az g[tg #I$'T_UhgXeb_ \f cexyxexag\t l `XgTUb_\mXW \a g[x ZTfgeb\agXfg\aT_ getvg& cexfh`tu_l Ul JLCK+7-( K[X ce\`tel ebhgx by X_\`\aTg\ba by T_UhgXeb_ XaTag\b`Xef \f g[ebhz[ exat_ XkVeXg\ba #2*! gb +**!$ by X\g[Xe g[x ctexag Vb`cbhaW be g[x ce\`tel `XgTUb_\gX( CXff g[ta,*! by g[x WehZ \f WXgXVgXW \a g[x YXVXf( =b bj\az \agetixabhf TW`\a\fgeTg\ba by etvx`\v T_UhgXeb_& UXgjXXa,/! TaW.0! by g[x #I$'T_UhgXeb_ YeTVg\ba by g[x WbfX jtf XkVeXgXW Tf hav[tazxw #I$'T_UhgXeb_ \a g[x he\ax( +

4 Special Populations Hepatic Impairment: K[X XYYXVg by [XcTg\V \`ct\e`xag ba g[x c[te`tvb^\axg\vf by 7Xebfb_ [Tf abg UXXa XiT_hTgXW( Renal Impairment: K[X XYYXVg by exat_ \`ct\e`xag ba g[x c[te`tvb^\axg\vf by etvx`\v T_UhgXeb_ jtf XiT_hTgXW \a / fhu]xvgf j\g[ VeXTg\a\aX V_XTeTaVX by 1 gb /- `C)`\a& TaW g[x exfh_gf jxex Vb`cTeXW j\g[ g[bfx Yeb` [XT_g[l ib_hagxxef( IXaT_ W\fXTfX [TW ab XYYXVg ba g[x [T_Y'_\YX& Uhg g[xex jtf T 01! WXV_\aX \a etvx`\v T_UhgXeb_ V_XTeTaVX( 9Thg\ba f[bh_w UX hfxw j[xa TW`\a\fgXe\aZ [\Z[ WbfXf by 7Xebfb_ gb ctg\xagf j\g[ exat_ \`ct\e`xag( Clinical Trials 5P_W^] MYP 5PZWQ]OQY^]2 K[X XYY\VTVl TaW ftyxgl by 7Xebfb_ jxex XfgTU_\f[XW \a gjb 2'jXX^& `h_g\vxagxe& etawb`\mxw& WbhU_X'U_\aW& TVg\iX' TaW c_tvxub'vbageb XW ge\t_f \a 1.2 TWh_gf TaW TWb_XfVXagf j\g[ Tfg[`T UXgjXXa g[x TZXf by +, TaW 2+ g[xfx gjb ge\t_f& 7Xebfb_ #.*- ctg\xagf$ jtf Vb`cTeXW gb Ta?=7'+-.T c_tvxub D;@ #+00 ctg\xagf$& TaW g[x ge\t_f \av_hwxw T `Te^XgXW T_UhgXeb_?=7'+-.T D;@ #+13 ctg\xagf$ Tf Ta TVg\iX Vbageb_( JXe\T_ YbeVXW Xkc\eTgbel ib_h`x \a + fxvbaw #=<M + $ `XTfheX`Xagf WX`bafgeTgXW g[tg 3* `VZ #, \a[t_tg\baf$ by 7Xebfb_ cebwhvxw f\za\y\vtag_l ZeXTgXe \`cebix`xag \a =<M + bixe g[x cexgextg`xag it_hx g[ta c_tvxub( K[X exfh_gf Yeb` bax by g[x ge\t_f TeX f[bja \a =\ZheX + Tf g[x `XTa cxevxag V[TaZX \a =<M + Yeb` gxfg'wtl UTfX_\aX Tg ;Tl + #a6../$ TaW ;Tl /0 #a6-21$( K[X exfh_gf Yeb` g[x fxvbaw ge\t_ jxex f\`\_te(,

5 ;US_\Q )2 DQ\OQY^ 7TMYSQ UY ;9I ) R\ZX GQ]^&8Mb 6M]QWUYQ UY 5P_W^] MYP 5PZWQ]OQY^] 5SQP )* ^Z 0) LQM\] M^ 8Mb ) MYP 8Mb -. Mean % Change in FEV Day 1 Xopenex HFA Inhalation Aerosol (n=219) Racemic Albuterol HFA 180 mcg (n=119) Placebo (n=107) Time (hours) 30 Day 56 Xopenex HFA Inhalation Aerosol (n=187) Mean % Change in FEV Racemic Albuterol HFA 180 mcg (n=105) Placebo (n=95) Time (hours) -

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