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ANNEX
I{"epublic r:l' thc Philippincs
Dcparlnrent of Ilcalth
FOOD ANT} URUG AI)M IN IS'I'I{A'I'I()N
26 Ap ril ?$?2
t
I. lior lnclusion
busilatc)
'fcln:i , :, rirlt { r\rnloclipine ti0 nr gl 5
'l'ablet
| , . beslrlntc.)
i
I
x,ir *flllIu,- _ ._l Dasage Strcrr Htfl i
i
Dosilgr Fcrnr
I
I
I
,j
l,-..-
| (ilrr: ;rl;- IMctlorlnirr I
I
i
i
'['n h lcr
t
i
I
iciisc lrr:11 ) t
I
I
t
(livic f)rivo. Filiuvcst Corlloratc City., Alahanl{ l78l h4untinlupa, l}lrilil:pincs lntgfiqaemr]]l
Sv*t*rri
'lirtnk Lirrc +0.i 3 85 7 900 1 Fax +6-l I 807 A75l tSStl{Sti$flx$i",
ulg
(a -l{oturrrla iogue tcr
Lsoluucittc, calciut:r
salt) Cak:ium-4-
rncthyl -?-0xu - v eilerate
.....101 rng
((, -Kctc':iltralcgur: ttr
Lcucinc, calciurn salt )
C'aiciuru-2-rtxu*.3 -
Phcnylpropiattate
..68 nrg
(ii-It$t r-)aualoguc t o
Ilhcnylalaninc, iaiciurn
saltl Calciunr-3-
nr etir5'l -2-oxo- butyrate
,""a,'86 ttrg
(a- l(ctnanalogue to
Valin*, calciunr salt)
l)osngc Sfrcngtlr
- it;;*s- I,1r,,;
250 rrrgfinl s,Jtti*,;m
(ll't l\/}
i 'iliiii*l'l'ahljit
t*-*
Cili;tiline 1Po 1tg _ *j__ *_lf i; i
t
I
i
5U nig
t---
I
t
t
I
I t rng/ l0 cui?
I
I
t.__
{9.5 msl24 hours}
i t 7
l,' .' . i
I
4"$r
ItivastiHnrinc (")
rng15 cr:r '[ransr.lcnnal Patu]r
!1,!111{/-lu horlrs)
Vrifi itlxet ine 5 nrg F ilur-( lnatcd 'l'nblct
(as hJclrr"rbronildg)
*Tir*rabJe'I-nG
Vortioxetine I [i rng
(,1.1' ltydrurl:yonlid*)
Vorlinxetirre --
l) r:ts Ijil nr -(loal etl' I'ablcl
{as hyclro[:rr:rnidc)
Vor"tioxetine 2A r11g F ihn-Clo*tecl Tatrlst
(as hyclrolrrouricle)
/,{trlrstttnirh3 100 nig Capsulc
Zorrisaluicle 50 lng Capsu lc
Zonisanricle 25 nl p; ! [-o{s
Pagr' 3 of'll
,, i.,r ;
r5 ,\f
i
{n
I
T
I
i
!-_
I
lt r
*-t
h,pirubicin 2 rrrg/rnl { I0 Cbnccntratr Siolutiorr tbr
rngiS ntl-,) Irr jectimr ( LV ilntravcsical)
{as 'l'r-ih.r-drate}
r\nrpriciitin las sodiunl) -i I g/Silfi nrg P"",rl* l*G;;;;;
S uIbar-:tanr (as sr:cl iuryJ {l.v,il.h,I.)
,{n:pici I Iin ti* ic,cf iiinil i '
500 mg / 350 rng Porvclcr {br Injcction
Sil jhar-:l;lrtr (as socliHrri)
*-
Anrpicillur (a.q socliunr) t P*;cfi;:rui lr;--ir*--
I r,lhacten: (ns socliupr )
(lMilv)
,\r'npr,:il i n { ar r"iiiri;;ri l-
1 75(,l lrrr,. Stcrils Porvdg fbr'
Sirll.nctai r i { ns sodiurn} Inj e ct ir:n
;\tnpiuiliin (as sodiunr) +" 1.5 g (1g + 500 g,) I'nrvclcr lor Injcctian
$u llractar:l (as soriiurn) V}
-[fl*Hr';tiffiryt5
llr,
!ii ',, I I'agc 4 *l'8
$t 16 {,o
i A,lpicillin (as sodium) - I
:
l"-
I.{ r, I)urvder lbr Inieutiuu
ii- SulLractarn (as sc,cliunr) I
(rMilv)
.i. ....-.-
t, "_...
i (lv/lM)
_ Sylhtctam ias.,sdjuill
i Atracurium (as besilate) lo *gfurl Srrlr,tt",, 1b.1,
I
rr,) {I.v.)
,fti:at*iu,r*"ifut* -l3lr*il'l
l0 nrg/ml, s;i'iii;'i iil i,uilii*iii iiii
l.V. Inlirsir:rr
t,-
I
i
ll utJeson icle ----J:!-ugfglr)
'25$ ntcg/tttl , Suspension lbr
I
(
I (500 rncglZ rrrl ,) Nelrulization
i
I
i
Budesonicle :oij i,*,a- Pres su ri't*d M st cr"ctl
I
I
Dosc Inhalcr'
I
lludcsorr iclc 200 rncg IJry llou'cler in Ca;rsul*
i
l. tor 0rrrI Inhalntiort
Rr.lde.sauicle 500 rncgirul-, I! ebu li'ti ng Su spertsi on
( I 000 m*glT rnl) (Sreril*)
lJucleson de 200 nicg per Achration Meterecl DoseInhaler
Budeson de 250 rtrcg/nr L " " Rflpirittory' Sgspcnsion
lludesonidc .200 mcg N4etcrcri I )osc Inhalal.iern
lJudesorride (:4 mcg pcr actuation Aqueous Nasai Spra1,
Buclesor:ide 200 nrcgrcloxe I:)owcler lor 1nhalatir-rrr
B sorricle / Fomrate rr:1
r,rcle 80 rncg 11.5 mcg P0 u,cler lirr Inha latiorr
Fuurarate Dilryclrate
I
I
I}ucl*sonide i Fonnoteroi , 320 mcg I 9 rr:cg per dosc tr)owdcr ftl- Inhalation
It,.*- Fumaratr: Diirydrate
iI
fJurlcrsorritie'"1- Z$A mcgi6 nlcg I)r'1' Pr:wclet- firr
j
I ltomroterol Furrrar ate Inlurlatit"rn
I Dilrydrati;
I
I
ij
Ce lazoiin (as socliurn) 500 mg Porvdcr Ior Injecticn
t
I
I
t
(IVIIMi
i ['clcpiit:,: {i,. i,i;.t"r.irtrr, t.Ul lg Pr.lrvrJcr fbr Inj*ct iorr
i
{1,tuI,i1,V,1
I
('trirrt;rx iri ;c { ;is sorlir,rrn } 25fi nrg Porvrlel" I'bt' Injeclion (tVi lM)
('* I riilx r ,iii I its sod iunr ) 1o
,t: l,.,i"ir*i ii,i iru iliii,;i
(lV lufusirur)
r"* ii tiri.ii i: i,-. i,,
"
pr',rru lu Ilawdcr {irr Injcction {lVilM)
{',;:il ;t/ t;.ii I; t,, (, l:, l",i,itlirtiiilL:,1 500 rng Porvclcr {irr Injcr:tiun {lfulil\i)
L'uli;tzitliur,-: { lrs pcn tahyclratc) lrr Ilorvdcr fbr I.V. I n t-us ion
l*titi,ir,,,i., tj,.; Sod i unr ) 1g Ilorvrlcr lirr Injcctiorr (lM/lV)
('c l1ri iixilrlil ( as Sorl iuun) ao Porvder lirr Injcctiun (lMllv)
ile firlil.\{uie (as riodiunr } lgi 50() nrg Porvdcr li:rr I njec:tion (I i\,lilV )
- sl l1:,1lti
iilll !iu_ s:-t_tligd. .,"__
{'cfir"i;tx$llc las sclrliunr} 500 rrrg Ilog,der lbr In jectinrr (l lt-4/lI')
{
q^. l$ ,{tlt
a
..,, ..]
I
I
{-le fh roxinrc (a s axct il ) 500 mg
I
{as lrydrochioriclc)
i
I
(as hydroshloride)
L:iprof'loxacin 3 rugirnL Solutinn frrr IV lrrfusion
(as hyrlrochloridc)
Cllirrrianrycin 3,00 rng Clapsu le t
as hydr n*hloride
Clinclarnyciu I 5n rnginr[.-
--
.q;;ilti;;;i ft;;ri,ii;ii,;
- i
as phosrlutl.e (l.ivI.il,v.1
Cllinclanrycin 150 nrg Capsr;lc i
i
as hydr'cchloriclc) i
i
I'agc 6 t.tl- 8
"t
/)-
T. ls vn
{12:5 rngin:L;l
IIe:;:;rrirr sodiurrr l{}00 ItJinrl. Solul iur t {i.x' I rrjectinrr ( IVlSq}
Levotloxacirr 500 rng/l00 mL Siolution fbr" tV Infhsicur
l,cl,of loxitcin (ns lrern ihydrate) 5 rn yf n{, Solutit>tr lirr tV It:{'usinrt
G",ii**il i-ffi,rlt yrtrrt-r 500 rng I' i I nr -Coated'["a[rlet
Lrlvo{ioxacir r (as lleurihyclratr:) 250 nrg, F i lrrr-(.loater:l l";rhl et
"['a
[-,r\'o f]oxacin ( as hemihydrate) 750 rns I;i lru -Cloatcd blet
Lc,T,o flclxacin (;ls hern ilrych'ate) 5 rrrg/5 nrl Solut ir.trt lor iutravcllous
(5(l() nrg/100 nrl-) inlLsion
l .evolloxacin (as herniirydrate) 5 rnginrL lbr intra t'elltrlls
Sol ul.icrn
(500 mglll00 url-) inlirsion
urnpcncill
h{ ts Porvclsr Fur In_isclion (lYj
Il{cropsnclrl ( as trilry<lratc) ls Purvcler For Injcction (lV)
h,'l crope r1cr11 500 rng Sterile Porvder lor Irrier:tion
MetroniCazotrc 500 nrg ,i l$() rnl. Solut ion For lrt.jr:ctiort
(0.5('n w/v)
rr:niilazole (as U*nhaale)',
N'l cl 125 mg I 5 rrrl {}r'3t
It orep inepl'lrine (as bitarlrate) I rns,i nr I.. Solution
(4 rurgi4 nrl-)
N r:repincplrine (ns bi tartratc) I rrrgi rn L Ct:rtceulrrrte ltrrIV lnIusion
1! orcpineplrI ine (ars tritar-tratc) L rtg,]l[. Solutior: Ii:r' Injcction
hior"cl: incl:lrri nc ('as bi tartr"ate) '1 fi1g1fu [, Cloncentrate fiir Solution Ior
(4 rnsr-i rn L; IV Inllsion
l)iperacillin (as .socliurn) * 4 gl50Ll nrg Irowder krr [n^icction (lVi
azuhactam (ars sodi u rn )
1'
Piyreracillin (as socliurn) -1" a 91500 rng Por.vder for IV Inlusion
'I'azobautam fas r*ocl i un:J
Iliperacillin (as sodium) * 2 gl25l) rng Por,r,dcr fbr lV Infusion
Tazohactam (as sodiurn)
I)iperacillin (as socliunr) -t- '[
? g l25t) urg Powder: l'or' [niection (lV)
r pze haq s;,1fffl?rt iu rsl _
i 00 rirg Lyophilizecl llor,vde r fcrr
Inicctiou ftrt' I.V. lrrfusion
I(ocurunium Bri:rniclc i(l ntili rui l
Solutir"rn for Iniectiorr (lV)
i,;,i:,.,iiiry"iii ls Powcler for iniection (1.V.)
\,'itrlcoln1.c irt
:-* -so!l ry;3. Parvclcr- f?x In iectir:rr (1. V.l
{l,ii r r r, r, i ;,'i i,, f ii r ty iii:.i rrii iii i ;il] 50fi nrt Ilowcler lior In.icction t'lV)
\'r ilrlcolrl 1,c in (a s |yclrocfu lclride) 1 Pr:u,rlcr l;r:lr Irr,iectir:q (lV) j
*
itu,iio,i, .;* il-i," ir),d"r.lrt0", e) I I (Xii , ,ii:l
-*?;;;;ilfi; -^:
hlicgljttt, I ttr; i
; ffi 1
L,*.1," r t,t.i iiir- r ){)i rill.,l
.
..* .*. i
\1, -,", *;;;;; ;l[,d r,.,ctri"iii-i
r i'
,
t. f'olrydur f or Injcctirr,:i j
( lV lnfirsinn ) i
[]nge 7 ol'f;
Shuulel yoLt have any eluestions/clarificatiorrs. kinclly adclrcss thern to thc fDA llolicy *ncl
I'lanuing Serrri ce at pps@fcla. gov.ph.
i'lge l{ trl'8