naTeHTeKC OBan H - PHARMA GARANT GmbH

- - (patentex
~HCTPYK4~s:I
(MH4>opMaLlMß
Anß nOTpe6MTeneM)
no np~MEHEH~1O
nPEnAPATA
naTeHTeKC OBan H
Oval N)
PerMCTpaLlMOHHblM HOMep B P:
nNQ015094/01 OT 23.12.05
ToprOBoe Ha3BaHMe:
naTeHTeKc GBan H
MHH:
HOHOKCI1HOn
XMMM'ieCKOe Ha3BaHMe:
p-HOHl1ncpeHOKCl1nnOnI13TOKCI13TaHOn
ßeKapCTBeHHaß 4>opMa:
cynn0311T0pl111Barl1HanbHble
COCTaB:
B 1 cynn0311T0pl111cop,ep>KI1T~:
AKH1BHOe BelljecTBo: HOHoKcI1Hon-9 - 75 Mr:
BcnOMoraTenbHble BelljecTBa:
nOnl13TI1neHrnl1KOnb (MaKPoron) 1500,
nOnl13TI1neHrnl1KOnb (MaKporon) 1000, BI1HHa~
KI1CnOTa, HaTpl1~ rl1p,poKap60HaT,
naYPl1ncyn~aT.
HaTpl1~
OnMC8HMe
Cynn0311T0pl1116enoro l.\BeTa
apMaKoTepaneBTM'ieCK8ß rpyn na:
KOHTpal.\enTl1BHoe
npl1MeHeHI1~
cpep,cTBo p,n~MecTHoro
Kop, A TX: G02BB
apMaKOnOrM'ieCKMe CBOMCTBa
naTeHTeKc GBan H-3TO BBOp,I1MbleBO snara-
nl1~e, yp,06Hble p,n~ npl1MeHeHI1~ neHo06pa3Y­
1O~l1e npOTI1B03ayaTOYHbie
cynn0311T0pl1l1.
(KoHTpal.\enTl1BHble)
Cynn0311T0pl111 naTeHTeKca GBan H npl1 TeMnepaType
Tena pacnnaBn~IOT~, 11,He3aBI1CI1MOOT
KOnl1yeCTBa Bnaranl1~Horo
06pa3YIOT neHY.
ceKpeTa,
npenapaT CHI1>KaeTnOBepxHocTHoe HaT~>KeHl1e
nl1nl1p,HOVlMeM6paHbi cnepMaT03011p,OB 11
He06paTl1Mo
p,BI1>KeHI1IO.
napanl13yeT I1Xcnoc06HocTb K
MeXaHl1yeCKOe p,eVlCTBl1e:cnepMaT0l.\l1p,HOe
Be~ecTBo paBHoMepHo pacnpep,en~cb BO Bnaranl1~e,
06pa3yeT CTa611nbHblVl6apbep. KOTOpblVl
npen~TCTByeT npOHI1KHOBeHl11OcnepMaTo­
3011p,OBB MaTKY.
npenapaT naTeHTeKc GBan H 06nap,aeT
npocpl1naKTI1YeCKI1M 3cpcpeKToM B OTHOWeHl111
I1HcpeKl.\l1V1,nepep,alO~l1xc~ nonOBblM nYTeM.
nOKa3aHMß K npMMeHeHMIO
KOHTpal.\enl.\l1~, B T. Y. Y >KeH~I1H:
• KOTopble XOT~T ynoTpe6n~Tb np0Tl1B03aYa­
TOYHoe cpep,cTBo TonbKO B Tex cnyYa~x, Korp,a
11M3TO Heo6xop,I1MO.
• KOTopble He I1MelOT peryn~pHblX
CHOWeHI1V1,
nonOBblX
• C Heperyn~pHblM MeHcTpyanbHblM 1.\I1KnOM.
• KOTopble XOT~TynoTpe6n~Tb npOTI1B03aYa­
TOYHOe cpep,CTBO He3aBI1CI1MOOT napTHepa.
• KOTopble no nlO6blM npl1YI1HaM p,On>KHbl
npeKpaTl1Tb (Ha KopOTKoe I1nl1 p,nl1TenbHOe
BpeM~) ynOTpe6neHI1e nepopanbHblX ropMO­
HanbHblX npOTI1B03ayaTOYHblX npenapaTOB,
• KOTopble ynoTpe6n~IOT neKapCTBeHHble
--

- -
cpeACTBa, CH~>KalOll1~e 3cpcpeKT~BHOCTb nepo­
panbHblX ropMoHanbHblX npOT~B03aLJaTOLJHbIX
npenapaTOB,
• An~ KOTOpblXynoTpe6neH~e APyr~x B~AOB
npOT~B03aLJaTOLJHbIXCpeACTB ~Bn~eTC~ OnaCHblM
An~ 3AOPOBb~ ~n~ CYll1eCTBYIOTnpOT~BOnOKa­
3aH~~ An~ ~x ynoTpe6neH~R
npOTMBOnOKa3aHM~
• nOBbIWeHHa~ LJYBCTB~enbHOCTb K npenapary
• aHOMan~~ pa3B~~~ nOnOBblX OpraHOB
• 3p03~~ WeLiiK~ MaTK~
Cnoco6 npMMeHeHM~M A03bl
06~3aTenbHblM ycnoB~eM 3cpcpeKT~BHOCT~
naTeHTeKC OBana H ~Bn~eTC~ erD npaB~nbHoe
np~MeHeH~e.
np~MeHeH~e naTeHTeKC OBana H BeCbMa
npOCToe. nepeA ynoTpe6neH~eM cynn03~op~Lii
BbIH~MaeTC~ ~3 6n~CTepa B MapK~pOBaHHOM
MeCTe (p~c. 1).
nepeA Ka>KAbIM nonOBblM aKTOM cynn03~op~Lii
BBOA~c~ rny60Ko BO Bnaran~ll1e (p~c. 2).
npenapaT CTaHOB~C~ aKT~BHbIM LJepe3 10 M~HYT
OT MOMeHTa BBeAeH~~ (p~c. 3).
3a 3TO BpeM~ aKT~BHoe cnepMaT0I.\~AHoe
Bell1ecTBo paBHoMepHo pacnpeAen~eTc~ no
Bnaran~ll1Y ~ 06pa3yeT cTa6~nbHblLii 6apbep,
KOTOPblLiinpenmcTByeT npOXO>KAeH~1OcnepMa­
T030~AoB B MaTKY (p~c. 4).
Ecn~ >Ke B TeLJeH~e 0AHOro LJaca nonoBoLii aKT He
3aKOHLJeH,He06xOA~MO nOBTopHoe BBeAeH~e
0AHOro cynn03~op~~, XOT~~ AOKa3aHO, LJTOnpena­
paT ~MeeT npOAOn>K~enbHOCTb AeLiicTB~~ 2 LJaca.
nepeA Ka>KAbIM HOBblM nonOBblM aKTOM He06xo­
A~MO nOBTOpHoe BBeAeH~e cynn03~op~~ Aa>Ke
~ B Tex cnYLJa~x, KorAa npOMe>KYTOKBpeMeH~
Me>KAYABYM~ nonOBblM~ aKTaM~ MeHee 1 LJaca.
naTeHTeKC OBan H MO>KHOnp~MeH~Tb B
TeLJeH~e An~enbHoro nep~oAa BpeMeH~.
n060"lHOe AeMcTBMe
npenapaT xopowo nepeHoc~c~ 060~M~ napT­
HepaM~. B peAK~x cnYLJa~x nO~Bn~eTC~ 0ll1Yll1e­
H~e TennOTbl. B cnYLJa~x HapyweH~~ Bar~Hanb­
HoLiiM~Kpocpnopbl B03MO>KHO0ll1Yll1eH~e 3YAa ~
>K>KeH~~BO Bnaran~ll1e ~n~ nonoBoro LJneHa.
nepeA03MpOBKa
He on~caHa.
83aMMOAeMCTBMe C APyrMMM neKapcT­
BeHHblMM npenapaTaMM
He ~MeeT c~cTeMHoro B03AeLiicTB~~
CDopMa BblnycKa
no 6 'Cynn03~op~eB B KOHrypHYIO ~LJeLiiKoBYIO
ynaKoBKY ~3 nneHK~ non~B~H~nxnop~AHoLii.
1~n~ 2 KOHrypHbie ynaKoBK~ BMeCTe C
~HCTpYKI.\~eLiino np~MeHeH~1O nOMell1alOT B
KapToHHYIO naLJKY.
YcnoBM~ xpaHeHM~
np~ TeMneparype He Bblwe 25°C, B HeAocryn­
HOMAn~ AeTeLii MeCTe.
CpOK rOAHocTM
2,5 roAa. He np~MeH~Tb no ~CTeLJeH~~ cpoKa
roAHOCT~, YKa3aHHoro Ha ynaKOBKe.
YcnOBM~ OTnYCKa M3 anTeK
5e3 pel.\ema.
npeAnpM~Me-npOM3BOAMTenb
MERZ 0-60318, IepMaH~~,
8«Mepl.\ ctJpaHKcpYPT-Ha-MaLiiHe ctJapMa fM6X ~ Ko. • KIäA ••
npeACTaB~enbCTBO B MocKBe
«Mepl.\ ctJapMa fM6X ~ Ko. KfaA ••:
1-~ yn. 71MCKOronon~ 9/13
TenecpoH: (495)2573810
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