País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
Oestradiol hemihydrate; Norethisterone acetate
Novo Nordisk Pharmaceuticals Pty Ltd
Medicine Registered
Product Information Tripi8.doc Page 1 of 16 PRODUCT INFORMATION TRISEQUENS ® NAME OF THE MEDICINE Oestradiol (as hemihydrate) Norethisterone acetate DESCRIPTION Trisequens is a sequential oestrogen/progestogen preparation formulated with the natural human oestrogen, oestradiol, and norethisterone acetate. The first 12 tablets in the calendar dial pack contain oestradiol alone. In the next 10 tablets norethisterone acetate is added to induce endometrial shedding. The last 6 tablets contain a low dose of oestradiol. This regimen provides adequate oestrogen replacement throughout the cycle and reduces the risk of endometrial hyperplasia. ACTIVE INGREDIENTS Oestradiol - chemical name: estra-1,3,5(10)-triene-3,17β-diol (as hemihydrate). Oestradiol is a white or almost white crystalline powder which is practically insoluble in water and soluble in acetone. Oestradiol has 5 chiral centres. The molecular formula is C 18 H 24 O 2 . Oestradiol hemihydrate has a molecular weight of 281.39. Norethisterone acetate - chemical name: 17 -acetoxy-19-nor-17-pregn-4-en-20-yn-3-one. Norethisterone acetate (NETA) is a white or yellowish-white crystalline powder which is practically insoluble in water and soluble in ethanol and acetone. Norethisterone acetate has 6 chiral centres. The molecular formula is C 22 H 28 O 3 , with a molecular weight of 340.5. STRUCTURE Oestradiol hemihydrate Norethisterone acetate CAS no.: 35380-71-3 CAS no. 51-98-9 EXCIPIENTS The tablet cores of the blue, white and red tablets contain: lactose, maize starch, hydroxypropylcellulose, talc, magnesium stearate. _Film-coatings _ Blue tablets: hypromellose, talc, titanium dioxide (E171), indigo carmine (E132) and macrogol 400. ’½H 2 O’ Product Information Tripi8.doc Page 2 of 16 White tablets: hypromellose, glycerol triacetate and talc. Red tablets: hypromellose, talc, titanium dioxide (E171), r Leer el documento completo