ruoounu. nnSlunCIS&UINI-rOSIlnS - the Society for Reproductive ...

NSnot due no potyeystle mtarianQr~elttdnoma.::.,....'I'ulE()UriI·.l:t··~ breastll, uterus" testis, ~us,iIPd pltuit!U't ~.- Prior bypersensitti'ity td Puregon!'_ Any condition in which a pregaaney (in~ ~ulliplepregnan'cy) would bepartlcu1arly haza11d()llJ(e.g, e:memesofwelght disorders and uterine abno~).- Unexplained vaginal b1 7 ed!ng.prepncy.PUREGON® - PRODUCT INFORMATION_Puregonoiscontraindicatedwhen an effective ~nse can-,not be obtained, suchas;- PrimarYovarian failure such as Indicated byhighlevels ofFSH.Organic disorders of the reproductive organs incompatible~ ma\forinationsof theut_ Puregon° should not be used in the elderly or in children,(vi) ~CAUTI()NS_k;I pregnancies occurring after induction of oVulation withgonadotropic preparations there is an increased risk ofmuItiplets.AnliIySls of pooled data does not indicate thllt the use ofgona4l:>trop/nlf lB ovulation induction and medically assisted.reproduction progrll1II8 cani.es an inereased risk of con,genjtallllll1tbrmations.- Priorthe foilL QtrefuI clinic:algeri.if:al. Pllthology.lI11 unacteptable increase in the amount of third SPllCe fluidacMa'pagenaentinclud~ac1n:liQlstration of limitedand serum albumin.t .ofetl1la, is recomq;for inadequate gonadal fuIlction,assessed;tion to deth't>'",!"",,,>,;w,,,,,,,Puregono100IU/o.5DlL Clear glass vials cont:airiib:g,.t6llitropinbeta 100 IU per 0.5 mL ofsolution for injection.Puregono150 lU/0.5DlL Clearglass vials cont3iDlgg.rfollitrQpmbeta 150 IU per 0.5 mL ofsolution for injectioni:Puregono 200 J:U/0.5mL Clearglass vials con~g(g1.\ittOPlnbeta 200 IU per 0.5 mL ofsolution for injPuregono 225 IU/0.5mL Clear glass vialsbeta 225 IU per 0.5 mL of solutiOl)fo~.~jPuregonO 250 IU/0.5mL Clearglassbeta 250 IU per 0.5 mL of solutionforlfi,jt;ctio~\i7f'Instructions for use/handlingThe freeze-dried substance is reconstirutevent.Puregon" solution for injectioJ;lis used lIS }.s.StoragePowderfor injection:Stored in the dark below 30·C (do not ;"",,,,,"'\ ,., ." ".Solution for injection:Stored at 2 to S·C (refrigerate, do not freeze).Shelf·life: All forms - two years whenstoredPuregono may be used until the expirationpackage.Powder for injection: Since an opened ampoule'01';ylal cannotbe resealed in such a way to further guarati~;ttie;jsterilltyof the contents, the solution should be used immediately afterreconstitution.Solutionfor injection: The entire contents ofthe vial shouldbe used in one injection.Vials are single-use only.The Information supplied relatesoruy to I'tiii:gdh-ahd lil:lQl!J