iF Fl ++ FU 11 W. tr Dt tr

g
10102124
03:10PM
No.l
iF Fl ++FU11W.tr Dt tr
Governoda Regiio Administrativa Especialde Macau
ffii+.H
Serviqosde Sairde
*ffitffiffi,
011I/DAF/I0
No ref.
Eff:
2410212010
Data/Date:
H
De/From:
Affairs
of Pharmaceutical
ffl3fl/Dept.: W+n+ffiffi. Department
- Department
Chief
: *'Xruf#ffi,F Dr. ChoiPengCheong
ffiE#lAss./Signat.
EHffi/Fax: (853)-28524016
Para/To
tE:
Ass./Subject:
*13F5/Dept.:
\kl*)vtAtt.-c/o:
€Hffi/Fax:
LABAs)Ae'EE!f *n'Aen
BetaAgonists,
HE€f Bqff9JAI(Long-Acting
Latest safety update on Lons-Acting Beta Aeonists(LABAs)
EI E,ff.
U3
N" folhasA{.pages:
E'=WFWhWtr
g-Acting
JtrWH ( usFDA) Eff ffiie € X + BfifrAFi{ Bq€gitrEtrtI(Lon
nIFE
LABAs)AA'HF!
BetaAgonists,
nWffiRtk ;flRLABAs
R#iH;fl , USFDAAr}ffiW,ffiffi
,fFffi
g}gXru#ffi,E^,fr jHH,fLH!JFI
. € 5T,fiffiE F.NI, XKq E F ffiW4 ffi.,USFDAFff
PA
#<MWWWIH6[.
+&ffi Jthffi
* YV,f+iHH* *ffi itHD/T SrF :
ffifrE#l?'
oAH-FxfnHtLABAsIl,'l^ffi
H!#WIfr
ffi,THEHffi
{FH"
Ff U+4trU6rffi
o rl€'Ff if f Hrf H!#YrJ&nTH26
X\Wf1JffH!)Fl7EIFf mf LABAs
"
LABAs
o {ffiEIFAD/ffi
HlEf , HWffi9,fliJ#lftiJIk,
trtr'fFffi
ffifrlLABAs{FH
ffiFfiXI4ftlJr#Fffi
"
.
*1WWWftU)EjH
M,ffi ffiffiffi{Hffitr X
o }*ifA€'{trffiffiEH+ry,^Hljfr!5r,Hfn*tr}+ffi
, 4[ffiF]gr[*fELABA,ffitgffiA€'*fE
'[4.
WWIID/'gT['frBF#FlJItFfft
ffiHH9&.-fELABAH!&fi
LABAsFf
d&#6
USFDA==HXF,I*jf
,frjFE'!,EuL)EHte'fFffi
tffi Ffi r'.reBA*f4ffi
UErffi
ffiffifl Flitff KtfrAFiH&JEIpA
"
ffi# : 4fll|ftfit$fitflffireA:Fif
AccuhalerAnhaler.
n qfiHffiryjfflfiWf\FJffr Seretide
SereventAccuhaler/Inhaler.Oxis TurbuhalerDlk SymbicortTurbuhaler"
Bs..#HtjHm4^H,f&ffii$€XA+4rj*E^tHFi{Bq€9itrtrtril4R1&WWllgrfi!{*,f
"JT
Rtr,H;fi0/T,\I+*fi=TIfuAffiE*F :
o
fffi*fffi+H - http:i/www.ssm.gov.mo/design/webservices/c_wservices_main.htm
- tW77+&Hf+Hft,KE6
o S116
slffi +i:+,l.:tF
o {sH 28s240r6
:
eie,tr{Att064
A4 ffiffit]l+ reee+-12E
SS-Mod. 064 ,;
FormatoA4 Imp. Dez. 1999
2
10/02/24 12:49PM
W FI f+ FUft E'.tr D[ ffi
Governoda RegidoAdministrativa Especialde Macau
fsi
(.
+.
H
Servigosde Saride
HT"l fEffi *WfuffiW-Hql4fthtq://www.ssm.gov.mo/design/services/serpt-chn.pdf
fE
lttT#E+E*f6.tnHI+lEEftFfi,;fffrt#+A\ffi
FfiF-{€s5e83s1748se8343e9qryJw%#tlg'
g
g|I
Wffi ffi ffi 4 Hm
4 iF*@lreWffiI|
Hfr
fr&,{frE K f; E!{HiE, i]i q-K tF#+a\ffi Ffi{Sry
\frfr
85008068.
-#f,X
hE!
United StatesFood and Drug Administration(UsFDA) notified healthcareprofessionalsabout the
latest safety update on Long-Acting Beta Agonists(LABAs) Due to safety concems,FDA is classlabeling changesfor all LABAs. Thesechangesare basedon FDA's analysesof studiesshowing an
increasedrisk of severeexacerbationof asthma symptoms, leading to hospitalizations in patients
as well as death in somepatientsusing LABAs for the treatmentof asthma.
Healthcareprofessionalsare reminded that to ensurethe safe use of theseproducts:
o
Single-ingredient LABAs should only be used in combination with an asthma controller
medication;they shouldnot be usedalone.
o
LABAs should only be used long-term in patients whose asthma cannot be adequately
controlled on asthmacontroller medications.
o
LABAs should be used for the shortestduration of time required to achievecontrol of asthma
symptomsand discontinued,if possible,once asthmacontrol is achieved.Patientsshould then
be maintained on an asthmacontroller medication.
o
Pediatric and adolescent patients who require the addition of a LABA to an inhaled
corticosteroid should use a combination product containing both an inhaled corticosteroid and
a LABA, to ensurecompliancewith both medications.
USFDA has determinedthat the benefits of LABAs in improving asthma symptoms outweigh the
potential risks when used appropriatelywith an asthmacontroller medication in patients who need
the addition of LABAs.
Note : The Long-Acting Beta Agonists authorized for distribution in the Macao market include
Seretide AccuhalerAnhaler . Serevent Accuhaler/Inhaler . Oxis Turbuhaler and Svmbicort
Turbuhaler.
If physicians, pharmacists or healthcare professionals suspect any kind of adverse reaction
subsequentto the use of Long-Acting Beta Agonists or other drug, pleasereport through any of the
following methods :
o Online - http://www.ssm.gov.mo/design/webservices/c_wservices_main.htm
r
o Mail to - 51 Avenida do Sidonio Pais,Edificio China Plaza,2noFloor, Macao S.A.R.,China
o Fax to - 853-28524016
ffii4.,trt6ttooa
Aq*Ht&Eltl*
reee
+12 tr
SS-Mod.Oe+\
FormatoA4 Imp. Dez. 1999
1010212412:49PM
iF Fl ++ElJft fi9E E[ F
Governoda RegidoAdministrativa Especialde Macau
lsi
+.
H
Serviqos de Saride
(..
The report form can be collected in person at Department of Pharmaceutical Affairs or
downloaded from the website designatedas http://www.ssm.gov.mo/design/sewices/serpt_chn.pdf.
Should you have any query, pleasecontactMs. BeatriceYoung or Mr. Jeffrey Lam at 8598-3517
or 8598-3439 respectively from the Division of Pharmacovigilanceand Pharmacoeconomics
during office hours. In caseofurgent situationsduring offhours, pleasepage85008068.
Thanking you in advancefor your attention!
tr*,
#fnHffi ff-*.
F
Chief of Departmentof PharmaceuticalAffairs
O€-€^^.. -5
*',(ru
f'+
Choi PengCheong
*4€fr+lReferencesI
http://www.fda.gov/Safety/MedWatch/Safetylnformation/SafetyAlertsforHumanMedicalProducts/
ucm201003.htm
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetylnformationforPatientsandProviders/
ucm200l76.htm
filHffit€'^w
A4ffiffitpl+reee
+12 tr
SS-Mod.064r
Formato A4 Imp. Dez. 1999